The Biden administration released the list of the first 10 Part D drugs subject to the price negotiation process established by the 2022 Inflation Reduction Act:

• Bristol-Pfizer’s Eliquis, used as a blood thinner;
• Eli Lilly’s Jardiance, used for diabetes and heart failure;
• Johnson & Johnson’s Xarelto, used as a blood thinner;
• Merck’s Januvia, used for diabetes;
• AstraZeneca’s Farxiga, used for diabetes and heart failure;
• Novartis’ Entresto, used for heart failure;
• Amgen’s Enbrel, used for autoimmune diseases;
• AbbVie-J&J’s Imbruvica, used for blood cancers;
• J&J’s Stelara, used for autoimmune diseases; and
• Novo Nordisk’s NovoLog, used for diabetes.

 

The Centers for Medicare and Medicaid Services plans to hold a public patient- focused listening session for each of the selected drugs between October 30, 2023, and November 15, 2023. The listening sessions will provide an opportunity for patients and other interested parties to share input on therapeutic alternatives to the selected drugs, how the selected drugs address unmet medical needs, and the impact of selected drugs on specific populations. Registration to apply to be a speaker opened on September 1, 2023, and will close on October 2, 2023. The public is also invited to submit data on selected drugs, therapeutic alternatives to the selected drugs, data related to unmet medical needs, and data on impacts on specific populations by October 2, 2023.

 

Majority Leader Steve Scalise Undergoing Treatment for Blood Cancer

House Majority Leader Steve Scalise (R-La.) has been diagnosed with multiple myeloma, “a very treatable blood cancer,” according to a statement released last week. Scalise has already begun treatment, which will last several months. He plans to return to Washington when the House of Representatives reconvenes later this month, and announced that he expects to continue his work as Majority Leader during this period.

 

White House Calls on Congress to Pass Continuing Resolution

The Biden administration formally asked Congress to pass a short-term spending bill to prevent a government shutdown at the end of the fiscal year on September 30. The White House is also seeking $40 billion in emergency spending as a part of the stopgap package. Conservatives in the House Freedom Caucus have already expressed opposition to any clean continuing resolution that does not include the Secure the Border Act, address the “unprecedented weaponization of the Justice Department and FBI,” and “end the Left’s cancerous woke policies in the Pentagon.” Both Democrat and Republican leaders of the Senate have signaled their support for a stopgap spending measure, and Senate Majority Leader Chuck Schumer (D-N.Y.) stated that the Senate’s focus will be on government funding when the chamber returns from August recess this week.

 

Doc Caucus Members Ask Appropriators to Act on Abortion Training Programs

The GOP Doctors Caucus sent a letter to House Appropriations Labor-Health and Human Services-Education Subcommittee Chairman Robert Aderholt (R-Ala.) in support of a change to physician training requirements that would result in medical residents having to opt-in to learn about abortion services, rather than the current process of allowing them to opt-out of such lessons. Several Doc Caucus members and former practicing OB/GYN Rep. Michael Burgess (R-Texas) raised concerns that the current opt-out process “is fundamentally unjust and places undue pressure on [residents] to partake in training that may conflict with their beliefs.” The letter encourages appropriators to prohibit federal funds from being used to implement opt-out curricula.

 

House Budget Panel Launches Health Care Task Force

House Budget Committee Chairman Jodey Arrington (R-Texas) recently announced the formation of a task force on health care. The task force will focus on bending the cost curve of health care, and will work to examine key drivers of health care costs and proposals to reduce health care spending. Rep. Michael Burgess (R-Texas) will serve as the chair of the task force, whose members include Reps. Drew Ferguson (R-Ga.), Buddy Carter (R-Ga.), Lloyd Smucker (R-Pa.), Blake Moore (R-Utah), and Rudy Yakym (R-Ind.). According to Arrington, the Task Force “will be guided by the principles that health care in America should be affordable, accessible, and personalized.” It plans to explore the Congressional Budget Office’s modeling and projection capabilities of health care policies “to ensure policymakers can access the best data when evaluating potential impacts on the federal budget and patients.” The task force issued a request for information (RFI) seeking comments by October 15 “on solutions to improve outcomes and reduce federal health care spending in the budget.”

 

NIH Nominee Reaches Agreement with Warren on Ethics Demands

Sen. Elizabeth Warren (D-Mass.) will support the confirmation of Monica Bertagnolli to serve as the Director of the National Institutes of Health (NIH) after the Biden administration nominee agreed to a pair of ethics demands. Bertagnolli agreed to not seek employment or compensation from any pharmaceutical company with an annual revenue of $10 billion or more for four years after leaving her government post. She also agreed to recuse herself from NIH decisions related to companies with which she has had a prior relationship for four years. The standard recusal period is two years. Bertagnolli’s path to confirmation is still complicated by Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sander’s (I-Vt.) refusal to schedule a hearing on her nomination. Sanders has pledged to oppose all administration health nominees until the White House takes unilateral action to cut drug prices. The NIH has been without a permanent leader since Dr. Francis Collins stepped down in December 2021.

 

Warren, Jayapal Urge FDA to Address Orange Book-Related Problems

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) sent a letter to the Food and Drug Administration (FDA) urging the agency to close alleged regulatory loopholes which they assert delay the entry of generic competition to the market and enable manufacturers of brand pharmaceuticals to keep high prices in place for longer periods of time. The lawmakers specifically recommend that the FDA narrow the patents allowed to be listed in the Orange Book, which is used by generic drug companies to determine when they can file a generic drug for approval. The letter also calls for increased information sharing between the FDA and the U.S. Patent and Trademark Office to help determine whether manufacturers are using the patent system in an anti-competitive manner.

 

New HHS OIG Strategy on Medicare, Medicaid Managed Care

The U.S. Department of Health and Human Services Office of the Inspector General (OIG) published a coordinated oversight plan for managed care in the Medicare and Medicaid programs last week. The strategy will be used to align OIG’s audits, evaluations, investigations, and enforcement of managed care. It aims to promote access to care for people enrolled in managed care, provide comprehensive financial oversight, promote data accuracy, and encourage data driven decisions. OIG’s work will be guided by the following managed care life cycle and the unique risks and vulnerabilities associated with each stage: plan establishment and contracting, enrollment, payment, and the provision of services.

 

POLICY BRIEFINGS

 

Department of Labor Proposes to Extend Overtime Protections

The Biden administration has proposed to revive an Obama-era regulation to require employers to pay overtime to salaried workers earning less than $55,000 a year. The regulation, which would increase the salary threshold for overtime from $35,668, would impact a total of 3.6 million employees, including approximately 600,000 individuals working in the nation’s health care and social services sectors. The notice of proposed rulemaking will be open for public comment for 60 days.

 

Recently Introduced Health Legislation

H.R.5269 – To amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment and maintenance of a Pediatric Research Site Network; Sponsor: Curtis, John R. [Rep.-R-UT-3]; Committees: House – Energy and Commerce

 

H.R.5287 – To direct the Secretary of Veterans Affairs to establish a pilot program to provide veteran health savings accounts to allow veterans to receive primary care furnished under non-Department direct primary care service arrangements, and for other purposes. Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Veterans’ Affairs

 

H.R.5299 – To amend title XVIII of the Social Security Act to establish a demonstration program for international coverage under the Medicare program; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5308 – To reauthorize the Distance Learning and Telemedicine Program of the Department of Agriculture; Sponsor: Langworthy, Nicholas A. [Rep.-R-NY-23]; Committees: House – Agriculture

 

H.R.5312 -To amend the Child Nutrition Act of 1966 to support women, infants, and children impacted by substance use disorder, and for other purposes; Sponsor: Manning, Kathy E. [Rep.-D-NC-6]; Committees: House – Education and the Workforce

 

H.R.5317 – To amend the Internal Revenue Code of 1986 to allow distributions from a health flexible spending arrangement or health reimbursement arrangement directly to a health savings account in connection with establishing coverage under a high deductible health plan; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Ways and Means

President Joe Biden plans to request additional funding from Congress for new COVID-19 vaccines. It is unclear whether the money would go toward research and development of an updated vaccine beyond the one already in development, or whether the administration will seek to restart the federal program providing free coronavirus shots for all Americans. In either case, the request is likely to meet opposition from Republicans on Capitol Hill. The Centers for Disease Control and Prevention is scheduled to meet on September 12 to discuss the latest round of COVID-19 vaccines to be deployed this fall.

 

Freedom Caucus to Oppose Clean CR

The House Freedom Caucus released a statement last week in anticipation of the use of a continuing resolution to fund the federal government beyond the end of the fiscal year on September 30. The Caucus stresses their support for reining in “reckless inflationary spending,” stating their refusal to support any stopgap spending measure that “continues Democrats’ bloated COVID-era spending.” The Freedom Caucus will oppose any clean, short-term funding bill that does not include the Secure the Border Act, address the “unprecedented weaponization of the Justice Department and FBI,” and “end the Left’s cancerous woke policies in the Pentagon.”

 

CBO Announces 2023 Panel of Health Advisers

The Congressional Budget Office (CBO) has announced the members of its Panel of Health Advisers for the coming year. The panel advises CBO on its cost analyses and provides assistance to support CBO’s understanding of “cutting edge research and the latest real-world developments in health care delivery and financing.” The complete list of advisers and their affiliations can be found here.

 

CMS Releases First Guidance on OOP Smoothing Program

The Centers for Medicare and Medicaid Services (CMS) released the first of two draft guidance documents last week to implement the Medicare Prescription Payment Plan Program. The program, which was established under the Inflation Reduction Act, will permit seniors to spread (or ‘smooth’) out their out-of-pocket (OOP) drug costs over a 12-month period. It is set to begin on January 1, 2025. The guidance instructs Part D plans on how to identify patients who may benefit from the program, how such patients should be notified via their pharmacy, and how insurers should reimburse pharmacies for the cost-sharing patients would otherwise pay upfront. Comments on the guidance are due September 20, 2023. A second guidance, planned for release early next year, will shed light on how the program will impact plan bids for 2025.

 

First Medicare Price Negotiation Drugs to Be Announced This Week

The Biden administration will announce the first 10 prescription drugs selected for the first round of the Inflation Reduction Act’s Medicare price negotiation policy early this week. The announcement is expected to precede a Tuesday event at the White House on lowering health care costs scheduled for 2 p.m. Eastern. Under the law, CMS is required to publish the list of up to 10 Medicare Part D drugs it selects for negotiation by September 1.

 

FDA Issues Warning Letters on Unapproved Skin Infection Treatments

The Food and Drug Administration (FDA) has issued six warning letters, including several to the nation’s major retailers, about the selling of unapproved products labeled to treat molluscum contagiosum. There are currently no over-the-counter products approved to treat the viral skin infection, which is common in children. The letters require the companies to respond within 15 days with evidence that they are no longer selling the products or that their sale is not in violation of FDA regulations, or risk further action by the agency.

 

Conservative Think Tanks Prepare Health Plans Ahead of 2024 Election

Paragon Health, the Heritage Foundation, and America First Policy Institute are at work drafting health policies in anticipation of the 2024 presidential election. Axios reported last week on work by the conservative think tanks to prepare health care policies and consider potential appointees should a Republican retake the White House next year. The plans include a focus on the use of association health plans, Medicaid block grants, site neutral payments, and an expansion of Trump-era transparency regulations.

 

WaPo Explores Geographic Distribution of Physician Income

The Washington Post published a recent article exploring the geographic distribution of physician income and why the nation’s highest paid doctors work in the Dakotas. While the nationwide average is $405,000, the average physician in their prime earning years (age 40 to 55) made $524,000 annually in South Dakota, while in North Dakota they made $468,000. Other rural states – Alaska, Wyoming, and Nebraska – round out the top five states for physician pay. The article suggests that the lack of competition in rural America may be responsible in part for these disparities in doctor pay, along with Medicare’s subsidization of seniors’ health care costs and the lack of variation in the program’s reimbursement rates for physician work from state-to-state.

 

Recently Introduced Health Legislation

H.R.5237 – To require the Comptroller General of the United States to submit a report on the effects of the fentanyl crisis, and for other purposes; Sponsor: Fry, Russell [Rep.-R-SC-7]; Committees: House – Energy and Commerce

 

H.R.5247 – To amend title 38, United States Code, to improve the authority of the Secretary of Veterans Affairs to hire psychiatrists; Sponsor: Cartwright, Matt [Rep.-D-PA-8]; Committees: House – Veterans’ Affairs

 

H.R.5256 – To amend title XVIII of the Social Security Act to provide payment under part A of the Medicare Program on a reasonable cost basis for anesthesia services furnished by an anesthesiologist in certain rural hospitals in the same manner as payments are provided for anesthesia services furnished by anesthesiologist assistants and certified registered nurse anesthetists in such hospitals, and for other purposes; Sponsor: Moolenaar, John R. [Rep.-R-MI-2]; Committees: House – Ways and Means

 

H.R.5259 – To direct the Secretary of Defense to include in periodic health assessments of members of the Armed Forces an evaluation of whether the member has been exposed to perfluoroalkyl substances and polyfluoroalkyl substances, and for other purposes; Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

 

H.R.5261 – To direct the Secretary of Defense to provide to each health care provider of the Department of Defense training regarding the potential health effects of perfluoroalkyl or polyfluoroalkyl substances; Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

Senate Majority Leader Chuck Schumer (D-N.Y.) has expressed support for a continuing resolution (CR) extending through early December to fund the federal government and avoid a government shutdown when current funding runs out at the end of the fiscal year (FY) on September 30. The Senate is scheduled to be in session only 17 days before the FY 2024 appropriations bills need to be passed, and the House will be in session only 12 days. Schumer stated that he has already spoken with House Speaker Kevin McCarthy (R-Calif.) about the passage of a stopgap spending measure as government funding negotiations continue. McCarthy himself recognized the need for such a temporary measure during a GOP conference call last week. The Speaker underscored the importance of the short-term bill lasting no later than early December.

Congress has used CRs to extend government funding through December in each of the last three years. This year, the House of Representatives has passed just one of the 12 annual appropriations bills, legislation to fund Military Construction, Veterans Affairs, and related agencies, while the Senate has passed none but reported all 12 bills out of committee before the August recess. Republicans in the House continue to have internal disagreements regarding overall spending levels and policy riders, such as those related to the politicization of the Department of Justice, abortion, and border security. Government funding negotiations could be further complicated by the need to attach the administration’s supplemental funding request – which is expected to be increased to account for growing disaster aid costs to respond to destructive wildfires in Hawaii – to a CR.

The latest debt limit deal included a provision to trigger a 1% across the board discretionary spending cut if the government is not fully funded by January 1. Senators are scheduled to return from August recess on September 5 and House members on September 12. Congress must also reauthorize by September 30 the SUPPORT Act, the Pandemic and All-Hazards Preparedness Act, the Children’s Hospitals Graduate Medical Education Program, and extend funding for the Community Health Center Fund.

 

WH Outlines R&D Priorities for FY 2025 Budget

The Biden administration is asking federal agencies to prioritize achieving better health outcomes in any research and development projects they might propose for funding in fiscal year (FY) 2025. The White House Office of Science and Technology Policy and the Office of Management and Budget (OMB) sent a memo on Thursday outlining R&D priorities for FY 2025 budget requests to OMB. The guidance includes funding activities related to the President’s Cancer Moonshot Initiative (with a focus on early detection, novel therapies, and prevention), antibiotic resistance and infectious outbreaks, preventing exposure to harmful chemicals, and mitigating the health effects of climate change.

 

Senate Democrats Comment on FDA’s Proposed Opioid Disposal Requirements

Agroup of ten Senate Democrats have sent a letter urging the Food and Drug Administration (FDA) to expand upon its proposed prescription opioid disposal policies. The agency’s April proposal, aimed at preventing abuse of and exposure to prescription opioids, would require patients be provided with mail-back envelopes and safe-disposal education when they are prescribed opioids in the outpatient setting. The lawmakers suggest that the FDA include a requirement for an at-home disposal option as well, highlighting that rural patients may not have regular access to the mail. The letter was led by Sens. Martin Heinrich (D-N.M.), Jon Tester (D-Mont.), and Patty Murray (D-Wash.). Comments on the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy are due by August 28.

 

ProPublica Reports on Hidden Payment Processing Fees

ProPublica published an article last week shedding light on the payment processing fees charged by insurers when they pay physicians for their work electronically. The creation of these fees follows the shift from paper to electronic processing and the subsequent growth of the payment processing industry. Public records requests made by New York urologist Alex Shteynshlyuger to the Centers for Medicare and Medicaid Services (CMS) revealed federal officials frequently deferring to the payment processing company Zelis, employer of a former CMS staffer and author of current federal standards for paying doctors via electronic funds transfers. In his capacity as vice president of legislative affairs at Zelis, Matthew Albright convinced CMS that a 2000 regulation prohibiting insurers from charging excessive fees for direct transactions did not apply to payment processors. The article details how physicians are often automatically enrolled in higher-fee payment methods without their consent. When they ask to by paid by paper check, insurers often resume electronic payments and the associated fees against the wishes of the provider. Payment processors argue their service offers doctors increased convenience and efficiency, allowing them to be reimbursed by many insurers through a single payment processor. The reporting highlights a survey which found that nearly 60% of medical practices are compelled to pay fees for electronic payment at least some of the time. A separate poll found that these fees can cost larger medical practices as much as $1 million each year.

 

Recently Introduced Health Legislation

H.R.5183 – To amend title XVIII of the Social Security Act to provide for coverage of cancer care planning and coordination under the Medicare program. Sponsor: DeSaulnier, Mark [Rep.-D-CA-10]; Committees: House – Energy and Commerce; Ways and Means.

 

H.R.5206 – To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Ways and Means

 

H.R.5207 – To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Ways and Means

 

H.R.5208 – To amend the Internal Revenue Code of 1986 to clarify the treatment of locum tenens physicians and advanced care practitioners as independent contractors to help alleviate physician shortages, including in underserved areas. Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Ways and Means

 

H.R.5212 – To amend the Federal Fire Prevention and Control Act of 1974 to make available under the assistance to firefighters grant program the establishment of cancer prevention programs, and for other purposes. Sponsor: Gottheimer, Josh [Rep.-D-NJ-5]; Committees: House – Science, Space, and Technology

 

H.R.5213 – To ensure that prior authorization medical decisions under Medicare are determined by physicians. Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House – Ways and Means; Energy and Commerce

The Biden administration released its request for $40 billion in supplemental funding for fiscal year 2024 last week. The supplemental budget request to Congress includes approximately $24 billion for continued aid to Ukraine. These emergency funds would not be subject to budget caps, and are likely to meet strong Republican opposition on the Hill. The request to meet critical needs also includes $350 million to support the Substance Abuse and Mental Health Services Administration and the federal response to the overdose epidemic. The money would be directed to states and territories via the State Opioid Response Grant program. The Indian Health Service would receive $50 million for the provision of substance use treatment and prevention services. Approximately $800 million of the $40 billion would be put toward efforts to reduce the supply of illegal fentanyl through the departments of Justice and Homeland Security.

 

Cassidy Urges Correct Implementation of Surprise Billing Law

Senate Health, Education, Labor, and Pensions Committee Ranking Member Bill Cassidy (R-La.) has sent a letter to Secretary of Health and Human Services Xavier Becerra urging the administration to correctly implement the No Surprises Act. Cassidy argues that rather “than implement the criteria as written in the statute, the Centers for Medicare and Medicaid Services took artistic license” and “deviated from the criteria,” which has resulted in numerous legal disputes. The letter outlines the adverse patient impacts that have resulted from the administration’s flawed implementation of the 2021 law and highlights the “lack of consistent, standardized information flow between parties and the absence of timely payments once a payment determination has been made.” Cassidy poses a series of over 40 questions covering issues including the qualifying payment amount, ensuring timely and accurate payments, the independent dispute resolution process, batching challenges, the administrative fee, and audit and enforcement authorities, and requests a response from Secretary Becerra by September 15.

 

Lawmakers Question Nonprofit Hospital Abuse of Tax-Exempt Status

Abipartisan group of senators are asking the Biden administration to investigate nonprofit hospitals’ compliance with community benefit requirements. These hospitals receive tax exemptions in exchange for community benefits – the provision of free or discounted care to low-income individuals. Sens. Elizabeth Warren (D-Mass.), Raphael Warnock (D-Ga.), Bill Cassidy (R-La.), and Chuck Grassley (R-Iowa) sent letters to the Internal Revenue Service and Treasury Department calling for an examination of the approximately $28 billion in nonprofit hospital tax exemptions. The lawmakers highlight concerns that the definition of community benefits is overly broad, allowing “some nonprofit hospitals to avoid providing essential care in the community for those who need it most.” The letter calls for the government to update the forms hospitals file to disclose charity care and to identify hospitals whose tax-exempt status was revoked and those that were audited or deemed at risk for non-compliance with charity care requirements.

 

Intelligence Chair Warner Comments On Google Medical Language Model

Senate Intelligence Committee Chairman Mark Warner (R-Va.) has sent a letter to the CEO of Google asking him to increase transparency, strengthen privacy, and establish ethical guardrails around the company’s medical language model dubbed Med-PaLM2. Warner cites reports of inaccuracies in the model, arguing that “premature deployment of unproven technology could lead to the erosion of trust in our medical professionals and institutions, the exacerbation of existing racial disparities in health outcomes, and an increased risk of diagnostic and care-delivery errors.” Google, which made Med-PaLM 2 available to a limited number of health care organizations for testing, has previously stated that users of its technology retain complete control of their data.

 

HHS Announces Funding to Grow Nursing Workforce

The U.S. Department of Health and Human Services (HHS) has announced that it will award more than $100 million to strengthen the nation’s nursing workforce. Nearly $65 million will be put toward advanced nursing education and nurse practitioner residency and fellowship programs. Another $26 million will be used to recruit and retain more nursing faculty. Approximately $9 million will support the training of licensed practice nurses to become registered nurses. The funding announcement is a part of a broader effort at HHS to grow the nation’s health care workforce.

 

UnitedHealthcare to Scale Back Use of Prior Authorization

Effective September 1 and November 1, UnitedHealthcare will move forward with a plan to reduce its overall volume of prior authorization requirements by 20% for the vast majority of its commercial and Medicaid members. The company has detailed which procedures would no longer be subject to prior authorization, including hundreds of codes for genetic testing. UnitedHealthcare also plans to implement a gold card program starting next year, which would eliminate prior authorization requirements for physicians with high approval rates. Cigna and Aetna have recently announced similar intentions to scale back some of their prior authorization requirements.

 

New WaPo Analysis of Physician Spread of COVID Misinformation

The Washington Post released a report last week investigating complaints against U.S. doctors for the spread of COVID-19 misinformation. The investigation’s survey of all 50 state medical boards found at least 480 COVID-19 misinformation related complaints. Only 20 doctors were officially sanctioned for their behavior, with five losing their licenses and only one having their license revoked. These providers often promoted unproven treatments like ivermectin and hydroxychloroquine for the treatment of COVID-19, or spread false statements about the use of vaccines and masks.

 

Recently Introduced Health Legislation

H.R.5138 – To amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital stay requirement for coverage of skilled nursing facility services under Medicare, and for other purposes; Sponsor: Courtney, Joe [Rep.-D-CT-2]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5142 – To amend the Public Health Service Act to make updates to the Vaccine Injury Compensation Program, and for other purposes; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Energy and Commerce

 

H.R.5143 – To amend the Internal Revenue Code of 1986 to provide authority to add additional vaccines to the list of taxable vaccines; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Ways and Means

 

H.R.5150 – To direct the Secretary of Defense to submit to Congress a report evaluating beneficiary access to TRICARE network pharmacies; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Armed Services

 

H.R.5151 – To require responsiveness testing of Defense Logistics Agency pharmaceutical contracts; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Armed Services

 

H.R.5159 – To amend title XVIII of the Social Security Act to ensure stability in payments to home health agencies under the Medicare program; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5163 – To amend the Controlled Substances Act to allow for the use of telehealth in substance use disorder treatment, and for other purposes; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Energy and Commerce; Judiciary

 

H.Res.649 – Calling on the United States to champion a regional artificial intelligence strategy in the Americas to foster inclusive artificial intelligence systems that combat biases within marginalized groups and promote social justice, economic well-being, and democratic values; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House – Foreign Affairs; Science, Space, and Technology

 

H.R.5165 – To amend title XIX of the Social Security Act to allow States more flexibility with respect to using contractors to make eligibility determinations and redeterminations on behalf of the State Medicaid plan, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

When Congress returns from recess in September, lawmakers will begin work to reconcile the differences between the two versions of the must- pass $886 billion National Defense Authorization Act (NDAA) advanced by each chamber earlier this summer. The Senate-passed annual defense authorization bill (S. 2226) does not include several contentious provisions attached to the House legislation. The House-passed defense policy bill (H.R. 2670) would prohibit time off and travel allowances for service members seeking abortions. It would also block military health insurance from covering gender hormone treatments or sex reassignment surgeries for transgender individuals.

The Senate is scheduled to reconvene on September 5, and the House is scheduled to return on September 12. In addition to passing the Pentagon spending measure, Congress has a lengthy list of other expiring programs and must-pass legislation to complete before September 30, including fiscal year (FY) 2024 government funding, the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization, animal drug user fee reauthorization, President’s Emergency Plan for AIDS Relief (PEPFAR) reauthorization, and funding for public health programs (community health centers, National Health Service Corps, Children’s Hospitals Graduate Medical Education, etc.).

 

Wyden Issues Letters on ADHD Medication Shortages

Senate Finance Committee Chairman Ron Wyden (D-Ore.) has sent a letter calling on makers of ADHD medication to either increase manufacturing or relinquish their remaining federal quota allotment to permit other manufacturers to produce more than their allotted quota of amphetamine and amphetamine products. According to a joint statement from the Food and Drug Administration and Drug Enforcement Administration (DEA), manufacturers are on track to fall one billion doses below quota. “The following actions are urgently needed,” Wyden argues. “Companies with spare quota allotments should relinquish them to the DEA so the DEA can approve applications from companies that have requested an increase; companies with excess production capacity that have met their quota allotment should apply for an increase; and manufacturers should sufficiently report voluntary and required information on their production, so the agencies have a complete understanding of how the shortage is being resolved and potential future shortages.”

 

Select Coronavirus Panel to Probe Vaccine Mandates

The House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic has launched an investigation into the development and implementation of vaccination policies and mandates. The panel plans to explore whether regulations stemming from the U.S. Department of Health and Human Services, the Department of Defense, and the Department of Labor stopped the spread and transmission of the coronavirus. According to Chairman Brad Wenstrup, DPM (R-Ohio), the panel will explore how the mandates came to be to inform congressional action in the case of a future pandemic.

 

Dr. Jeanne Marrazzo Named New Head of NIAID

Dr. Jeanne Marrazzo has been named the new director of the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Marrazzo is currently the director of the Division of Infectious Diseases at the University of Alabama at Birmingham. She is expected to begin her role as NIAID Director in the fall. She will replace Hugh Auchincloss, Jr., M.D., who has served as acting director of NIAID after long-time director Anthony S. Fauci, M.D., stepped down in December 2022. Dr. Marrazzo’s research has focused on the human microbiome, specifically as it relates to female reproductive tract infections and hormonal contraception; prevention of HIV infection using biomedical interventions; and the pathogenesis and management of bacterial vaginosis, sexually transmitted diseases in HIV-infected persons, and management of antibiotic resistance in gonorrhea. Dr. Marrazzo is a Fellow of the American College of Physicians and of the Infectious Diseases Society of America and is board certified in infectious diseases.

 

White House Launces New Pandemic Preparedness Office

The White House announced the launch of the Office of Pandemic Preparedness and Response (OPPR) Policy last week. It will be a permanent office in the Executive Office of the President charged with leading, coordinating, and implementing actions related to preparedness for, and response to, known and unknown biological threats or pathogens that could lead to a pandemic or to significant public health-related disruptions in the US. OPPR will take over the duties of the current COVID-19 Response Team and Mpox Team at the White House and will continue to coordinate and develop policies and priorities related to pandemic preparedness and response. Major General (ret) Paul Friedrichs has been selected as the office’s inaugural director. Friedrichs previously served as Joint Staff Surgeon at the Pentagon and as medical adviser to the Department of Defense Covid-19 Task Force.

 

HHS Announces Formation of Long COVID Office

The U.S. Department of Health and Human Services (HHS) has launched a new Office of Long COVID Research and Practice. The office will coordinate the federal government’s response to the long-term effects and associated conditions of COVID-19. The Office of Long COVID Research will be located within HHS’s Office of the Assistant Secretary for Health under the leadership of the HHS Assistant Secretary for Health, Admiral Rachel Levine. The Office is charged with on-going coordination of the whole-of-government response to the longer-term effects of COVID-19, including Long COVID and associated conditions and the implementation of the National Research Action Plan on Long COVID and the Services and Supports for Longer-Term Impacts of COVID-19. Fourteen federal departments currently engage on long COVID, including over a dozen HHS Operating and Staff Divisions with the goal of reducing the impacts of long COVID by improving quality of life for people living with long COVID and reducing disparities related to long COVID.

 

March of Dimes Releases New Data on Maternal Care Deserts

The nation saw a 4% decline in the number of hospitals offering labor and delivery services between 2019 and 2020, according to new data from the March of Dimes. This figure captures significant disparities across the nation – with Alabama and Wyoming losing nearly 25% of their birthing hospitals during this time, and Idaho, Indiana, and West Virginia losing nearly 10%. Approximately 5.6 million women currently reside in counties with no access to maternity care, while 32 million women are at risk of poor health outcomes because of a lack of nearby maternity care options. The March of Dimes characterizes more than one-third of all U.S. counties as maternal care deserts because of their lack of access to reproductive health services. The problem is particularly acute in rural areas and states that have not expanded their Medicaid programs. The U.S. currently has the worst maternal mortality rate among developed nations. The impact of the Supreme Court’s overturning of Roe v. Wade on maternal health remains unclear, as the report relies on data gathered in 2020 and 2021 prior to the Supreme Court’s ruling.

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

H.R.5074 – To amend the American Taxpayer Relief Act of 2012 to delay implementation of the inclusion of oral-only ESRD-related drugs in the Medicare ESRD prospective payment system. Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5076 – To clarify that, in awarding funding under title X of the Public Health Service Act, the Secretary of Health and Human Services may not discriminate against eligible States, individuals, or other entities for refusing to counsel or refer for abortions. Sponsor: Cole, Tom [Rep.-R-OK-4]; Committees: House – Energy and Commerce

 

H.R.5077 – To establish the National Artificial Intelligence Research Resource, and for other purposes. Sponsor: Eshoo, Anna G. [Rep.-D-CA-16]; Committees: House – Science, Space, and Technology

 

H.R.5080 – To amend the Internal Revenue Code of 1986 to exclude certain Nurse Corps payments from gross income. Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Ways and Means

 

H.R.5093 – To amend title XVIII of the Social Security Act to preserve sole community hospital determinations made by the Secretary of Health and Human Services, and for other purposes. Sponsor: Waltz, Michael [Rep.-R-FL-6]; Committees: House – Ways and Means

 

H.Res.639 – Supporting the goals and ideals of “Minority Mental Health Awareness Month” and recognizing the disproportionate impacts of mental health conditions and struggles on minority populations and communities; Sponsor: Crockett, Jasmine [Rep.-D-TX-30]; Committees: House – Energy and Commerce

 

H.Res.640 – Addressing the national crisis of suicide among minority adolescents; Sponsor: Espaillat, Adriano [Rep.-D- NY-13]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.5116 – To amend the Public Health Service Act to extend health information technology assistance eligibility to behavioral health, mental health, and substance abuse professionals and facilities, and for other purposes; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce

 

H.R.5128 – To amend title XVIII of the Social Security Act to ensure stability in payments to home health agencies under the Medicare program; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Ways and Means; Energy and Commerce

Lawmakers completed their final workdays before the congressional August recess last week. While the Senate passed its $886 billion annual defense policy bill with overwhelming bipartisan support, Foreign Relations Chair Bob Menendez (D-N.J.) was unsuccessful in his attempt to attach a five-year reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR) to the National Defense Authorization Act. Republicans are pushing to restore a Trump-era abortion restriction blocking funding for any groups that provide or promote abortion as a part of PEPFAR reauthorization.

For the first time since 2018, the Senate Appropriations Committee has completed work on all 12 annual spending bills, advancing the Labor-Health and Human Services-Education package out of committee on Thursday. All 12 of the Senate appropriations measures received bipartisan support. The Labor-HHS bill includes $224.4 billion in funding, a roughly $14.5 billion increase. The U.S. Department of Health and Human Services Department (HHS) would receive $117 billion. A full summary of the bill is available here. Bill text, as amended, is available here. The bill report, as amended, is available here. Adopted amendments are available here. Congressionally Directed Spending projects included in the bill are available here.

On the House side, Republicans pivoted away from plans to vote on the chamber’s fiscal year (FY) 2024 Agriculture-Rural Development-Food and Drug Administration appropriations bill on the floor last week. The bill faced pushback from conservatives demanding further spending cuts. Several moderate members also expressed reservations about a policy contained in the bill to restrict access to the abortion medication mifepristone.

The Senate is scheduled to reconvene on September 5, and the House is scheduled to return on September 12. Lawmakers will have a lengthy list of expiring programs and must-pass legislation to complete before September 30, including FY 2024 government funding, the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization, animal drug user fee reauthorization, PEPFAR reauthorization, and funding for public health programs (community health centers, National Health Service Corps, Children’s Hospitals GME, etc.).

 

Congress Passes Bill to Overhaul Nation’s Organ Transplant System

Congress passed the Securing the U.S. Organ Procurement and Transplantation Network Act (H.R. 2544) to increase competition in the nation’s organ transplant network last week. The bill would allow the Health Resources and Services Administration to open competitive bidding on multiple contracts for public and private entities to manage the Organ Procurement and Transplantation Network (OPTN). The legislation would also require a Government Accountability Office report on the financing of OPTN. The United Network for Organ Sharing (UNOS) has managed the OPTN contract since 1986. The current OPTN contract with UNOS is set to expire and be up for renewal on September 30. The legislation passed the House of Representatives by voice vote and was adopted by the Senate through unanimous consent. The bill will now be sent to President Joe Biden to be signed into law.

 

Senate Finance Advances PBM Package

The Senate Finance Committee voted 26-1 to advance a series of proposals to reform the pharmacy benefit manager (PBM) industry last week. Sen. Ron Johnson (R-Wis.) was the only member to vote against the bill. The Modernizing and Ensuring PBM Accountability (MEPA) Act would delink PBMs’ compensation from manufacturer list prices, requiring that payments to PBMs be based on a bona fide service fee that is not tied to the list price of a drug. It would ban the practice of spread pricing in state Medicaid programs, and require Medicare Advantage and Part D plans to use standardized pharmacy performance measures for the purposes of incentive payments, price concessions, or fees charged to a pharmacy. The bill also directs the U.S. Department of Health and Human Services Office of the Inspector General to review the state of PBM compensation and to study Part D drug mark-ups. The Congressional Budget Office (CBO) estimates that the measure would produce approximately $666 million in savings through 2028. The measures will likely be made a part of a larger package of drug pricing reforms expected to be considered by the Senate before the end of the year. In a statement released following Wednesday’s markup, Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) committed “to continue working on additional proposals that will constitute a more comprehensive suite of reforms, and requested feedback from the CBO on proposals that would help to cut out-of-pocket costs, increase pharmacy access and (ensure) that seniors benefit from lower-cost biosimilars.”

 

House Ways and Means Approves Health Care Transparency Bills Along Party Lines

The House Ways and Means Committee advanced legislation to increase transparency in the nation’s health care system last week. The Health Care Price Transparency Act (H.R. 4822) would require pharmacy benefit managers and group health plans to submit an annual report to Part D plan sponsors containing a series of information on prescription drug pricing and spending effective three years after enactment of the legislation. It would also limit beneficiary cost sharing in Part D to no more than the average net price of a drug staring in 2027. The bill also included provisions to address prior authorization policies in Medicare Advantage based on the bipartisan Improving Seniors’ Timely Access to Care Act which passed the House in the 117th Congress. The Providers and Payers COMPETE Act (H.R. 3284) would require an annual report from the U.S. Department of Health and Human Services on the effect of Medicare regulations on provider and payer consolidation, and the impact of such consolidation on the health care delivery system. The bills were approved by party line votes. Democrats argued that the bills will not meaningfully lower prescription drug costs, and expressed opposition to the exemption of Medicare Advantage plans from increased transparency requirements and the absence of reporting requirements to shed light on private equity involvement in the health care system. The two bills are expected to be incorporated into a larger health care package that includes other price transparency legislation advanced by the Education and the Workforce and Energy and Commerce committees earlier this year.

 

Sanders Postpones Primary Care, Workforce Markup

Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders (I-Vt.) postponed consideration of his primary care and health workforce package originally scheduled for markup last Thursday. In Sanders’ statement announcing the change of plans, the Chairman indicated that he is working with Sen. Roger Marshall, MD (R-Kan.) to prepare a “major piece of bipartisan primary care legislation” for consideration by the first week of September. The original package proposed by Sanders faced opposition from Republican members of the committee, who argued that the funding authorized by the measure – totaling $100 billion – was too high. The bill included between $10.2 billion and $13.42 billion per year for community health centers. It would have also prohibited hospitals from charging facility fees for services provided by off-site physicians. The reauthorization package advanced out of the House Energy and Commerce Committee provides only a slight increase for community health centers – from $4 billion to $4.2 billion annually for the next two years.

 

Lawmakers Urge Medicare Physician Payment Reform

Agroup of 101 lawmakers led by Reps. Larry Bucshon (R-Ind.) and Ami Bera (D-Calif.) have sent a letter to House of Representatives leadership on the need to prioritize Medicare physician payment reform. The lawmakers argue that the Medicare physician payment system’s failure to maintain levels of reimbursement and to adequately incentivize high- quality care has led to poorer health outcomes and shortages of health care providers. The lawmakers urge Congress to enact reforms to the Medicare Access and CHIP Reauthorization Act and to establish a stable payment mechanism that appropriately pays for health outcomes in order to “keep our patients safe, access to care available, and the health care workforce strong.”

 

E&C Republicans Release Drug Shortages Discussion Draft

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) released a discussion draft last week containing proposals to address the nation’s ongoing drug shortages. The bill would provide manufacturers of generic, sterile injectable drugs for serious diseases more market flexibility to invest in manufacturing and speed production when potential shortages arise. The draft would increase group purchasing organization disclosure requirements, require the Food and Drug Administration to exercise its existing reporting requirement authorities, and establish a pilot program to conduct preapproval inspections of new domestic sterile manufacturing facilities. It would also require analysis of the impact of federal policies like the 340B drug pricing program, the Medicaid generic drug inflationary rebate, and Medicare reimbursement policy on drug shortages. Feedback on the discussion draft should be submitted to [email protected] by August 25, 2023. Ranking Member Frank Pallone, Jr. (D-N.J.) criticized the bill, expressing concerns that its proposals are “handouts to pharmaceutical corporations that would increase costs for patients and potentially lead to more shortages.”

 

Bipartisan, Bicameral RFI on CBD Regulation

Bipartisan leadership of the Senate Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee are requesting information from stakeholders about the Food and Drug Administration’s (FDA) regulation of cannabidiol (CBD). The effort seeks to address questions about the best way to provide a legal pathway to market for CBD products, and follows an announcement by the FDA earlier this year on the need for legislation to inform CBD product regulation. The information gathered will support the lawmakers’ assessment of the potential for a regulatory pathway for hemp-derived CBD products that prioritizes consumer safety and provides certainty to the U.S. market. Comments in response to the request for information (RFI) are due to the committees ([email protected] and [email protected]) by August 18.

 

POLICY BRIEFINGS

 

Lawmakers Reintroduce Value in Health Care Act

Reps. Darin LaHood (R-Ill.), Suzan DelBene (D-Wash.), Kim Schrier, MD (D-Wash.), Brad Wenstrup (R-Ohio), Earl Blumenauer (D-Ore.), and Larry Bucshon, MD (R-Ind.) have reintroduced a bipartisan bill (H.R. 5013) that aims to increase participation in Accountable Care Organizations (ACOs). The Value in Health Care Act would revise Medicare’s Alternative Payment Models program to incentivize greater participation in value-based health care. The legislation would increase the percentage of shared savings beginning participants receive, modify program risk adjustment and performance metrics, strengthen technical support for participants, and extend the annual lump sum participation bonus for an additional two years.

 

Burgess Reintroduces GOLD CARD Act

Rep. Michael C. Burgess, MD (R-Texas) has reintroduced the Getting Over Lengthy Delays in Care As Required by Doctors (GOLD CARD) Act (H.R. 4968). The bill would exempt qualifying providers from prior authorization requirements under Medicare Advantage (MA) plans. The exemption would apply to providers who had at least 90% of prior authorization requests approved the preceding year. In related news, the Improving Seniors’ Timely Access to Care Act was advanced by the House Ways and Means Committee as a part of the Health Care Price Transparency Act last week. The measure would modernize the use of prior authorization in the MA program by establishing an electronic prior authorization process, requiring the U.S. Department of Health and Human Services to establish a process for real-time decisions for items and services that are routinely approved, and requiring MA plans to report on the extent of their use of prior authorization and their rate of approvals or denials.

 

Democrats Introduce Bill to Expand IRA Drug Pricing Provisions

House Democratic committee leaders introduced legislation (H.R. 4895) last week that aims to expand the impact of the Inflation Reduction Act’s drug pricing provisions. The Lowering Drug Costs for American Families Act would extend the drug price negotiation program to all Americans with private coverage, apply the law’s inflation rebates to individuals covered by private health plans, and increase the annual number of prescription drugs subject to negotiation from 20 to 50. The bill was introduced by Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-N.J.), Ways and Means Committee Ranking Member Richard E. Neal (D-Mass.), and Education and the Workforce Committee Ranking Member Robert C. “Bobby” Scott (D-Va.).

 

White House Releases Report on Compliance with Mental Health Parity Law

The Biden administration released a report to Congress last week on the state of compliance with the Mental Health Parity and Addiction Equity Act. It is the first time that such a report names the health insurance plans that are failing to meet the requirements of the law. Six categories of compliance problems are identified in the report, including prior authorization requirements for in-network and out-of-network inpatient services; concurrent care review for in-network and out-of-network inpatient and outpatient services; standards for provider admission to participate in a network; out-of- network reimbursement rates and how they were determined; impermissible exclusions of key treatments for mental health conditions; and adequacy standards for mental health provider networks. The report also includes examples of corrective actions plans have taken to address their deficiencies. The report was released in conjunction with a new proposed rule to strengthen the standards for health plans to meet the requirements of the mental health parity statute.

 

ARPA-H Launches Cancer Surgery Program

The Advanced Research Projects Agency for Health is seeking proposals for its first cancer focused program dubbed Precision Surgical Interventions (PSI). PSI aims to help all surgical procedures reach their intended goal with no errors and no need for re-operation. It will work toward developing solutions to two major surgical problems: tumor edge visualization and critical anatomy visualization. Proposer’s Day for interested researchers will open September 7.

 

Recently Introduced Health Legislation

H.R.4822 – To improve price transparency with respect to certain health care services, and for other purposes; Sponsor: Smith, Jason [Rep.-R-MO-8]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce; Budget

 

H.R.4827 – To require applications for a health profession opportunity grant under section 2008 of the Social Security Act to contain evidence of in-demand jobs or worker shortages; Sponsor: Boyle, Brendan F. [Rep.-D-PA-2]; Committees: House – Ways and Means

 

H.R.4828 – To amend title XVIII of the Social Security Act to promote price transparency for imaging tests under the Medicare program; Sponsor: Carey, Mike [Rep.-R-OH-15]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.4829 – To amend the Public Health Service Act to provide for the participation of physical therapists in the National Health Service Corps Loan Repayment program, to amend title XVIII of the Social Security Act to expand Medicare Rural Health Clinic Services and Federally Qualified Health Center Services to include physical therapy services, and for other purposes; Sponsor: DeGette, Diana [Rep.-D-CO-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4830 – To establish an interactive online dashboard to improve public access to information about grant funding related to mental health and substance use disorder programs; Sponsor: Gonzales, Tony [Rep.-R-TX-23]; Committees: House – Energy and Commerce

 

H.R.4832 – To amend the Indian Self-Determination Act and the Indian Health Care Improvement Act to provide advance appropriations authority for certain accounts of the Bureau of Indian Affairs and Bureau of Indian Education of the Department of the Interior and the Indian Health Service of the Department of Health and Human Services, and for other purposes; Sponsor: McCollum, Betty [Rep.-D-MN-4]; Committees: House – Natural Resources; Energy and Commerce; Education and the Workforce; Budget

 

H.R.4833 – To provide grants for the conduct of demonstration projects designed to provide education and training for eligible individuals to enter and follow a career pathway in the field of pregnancy, childbirth, or post-partum, under the health profession opportunity grant program under section 2008 of the Social Security Act; Sponsor: Moore, Gwen [Rep.- D-WI-4]; Committees: House – Ways and Means

 

H.R.4837 – To amend the Public Health Service Act to help build a stronger health care workforce; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4839 – To amend title XVIII of the Social Security Act to require certain facilities under the Medicare program to disclose certain information relating to charges and prices; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Ways and Means; Energy and Commerce

 

S.2459 – A bill to amend title XVIII of the Social Security Act to ensure appropriate supervision requirements for outpatient physical therapy and outpatient occupational therapy, and for other purposes; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

 

S.2464 – A bill to amend title XXVII of the Public Health Service Act to prohibit group health plans and health insurance issuers offering group or individual health insurance coverage from imposing cost-sharing requirements with respect to diagnostic and supplemental breast examinations; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2465 – A bill to require the Secretary of Veterans Affairs to establish a pilot program to furnish doula services to veterans; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Veterans’ Affairs

 

S.2474 – A bill to amend title XVIII of the Social Security Act to ensure appropriate cost-sharing for chronic care drugs under Medicare part D; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Finance

 

S.2476 – A bill to amend the Public Health Service Act to provide for a behavioral and mental health outreach and education strategy to reduce stigma associated with mental health among the Hispanic and Latino population, and for other purposes; Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2477 – A bill to amend title XVIII of the Social Security Act to provide pharmacy payment of certain services; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

S.2481 – A bill to amend title XIX of the Social Security Act to encourage appropriate prescribing under Medicaid for victims of opioid overdose; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Finance

 

S.2483 – A bill to amend the Public Health Service Act to provide additional transparency and consumer protections relating to medical debt collection practices; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2485 – A bill to award posthumously a Congressional Gold Medal to Henrietta Lacks, in recognition of her immortal cells which have made invaluable contributions to global health, scientific research, our quality of life, and patients’ rights; Sponsor: Van Hollen, Chris [Sen.-D-MD]; Committees: Senate – Banking, Housing, and Urban Affairs

 

S.2493 – A bill to require the Medicare Payment Advisory Commission (MedPAC) submit to Congress two reports on arrangements with pharmacy benefit managers with respect to prescription drug plans MA-PD plans; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

H.R.4846 – To amend the Internal Revenue Code of 1986, title XXVII of the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 to provide for oversight of pharmacy benefit manager services; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.4849 – To allow for hemp-derived cannabidiol and hemp-derived cannabidiol containing substances in dietary supplements and food; Sponsor: Blumenauer, Earl [Rep.-D-OR-3]; Committees: House – Energy and Commerce

 

H.R.4851 – To provide for improvements in the implementation of the National Suicide Prevention Lifeline, and for other purposes; Sponsor: Cárdenas, Tony [Rep.-D-CA-29]; Committees: House – Energy and Commerce; Ways and Means; Armed Services; Veterans’ Affairs; Oversight and Accountability

 

H.R.4874 – To provide for technical assistance under the health profession opportunity grant program under section 2008 of the Social Security Act; Sponsor: Kildee, Daniel T. [Rep.-D-MI-8]; Committees: House – Ways and Means

 

H.R.4878 – To amend title XVIII of the Social Security Act to ensure appropriate supervision requirements for outpatient physical therapy and outpatient occupational therapy; Sponsor: Lesko, Debbie [Rep.-R-AZ-8]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4881 – To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program; Sponsor: Malliotakis, Nicole [Rep.-R-NY-11]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4882 – To amend title XVIII of the Social Security Act to promote laboratory price transparency under the Medicare program; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.4883 – To amend title XVIII of the Social Security Act to require the disclosure of certain ownership information relating to health care provider and pharmacy ownership, and for other purposes; Sponsor: Murphy, Gregory [Rep.-R- NC-3]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.4884 – To amend the Public Health Service Act to provide for a behavioral and mental health outreach and education strategy to reduce stigma associated with mental health among the Hispanic and Latino population, and for other purposes; Sponsor: Napolitano, Grace F. [Rep.-D-CA-31]; Committees: House – Energy and Commerce

 

H.R.4885 – To improve training requirements for health profession opportunity grant programs and exclude assistance provided by those programs from income tax, and for other purposes; Sponsor: Panetta, Jimmy [Rep.-D-CA-19]; Committees: House – Ways and Means

 

H.R.4886 – To provide for a study by the National Academies of Sciences, Engineering, and Medicine on the prevalence and mortality of cancer among individuals who served as active duty aircrew in the Armed Forces, and for other purposes; Sponsor: Pfluger, August [Rep.-R-TX-11]; Committees: House – Veterans’ Affairs

 

H.R.4892 – To amend title XIX of the Social Security Act to provide a higher Federal matching rate for increased expenditures under Medicaid for behavioral health services (including those related to mental health and substance use), and for other purposes; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

S.2510 – A bill to improve supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2511 – A bill to expand psychological mental and behavioral health services to Medicare, Medicaid, and CHIP beneficiaries by permitting reimbursement of psychological services provided by certain supervised psychology trainees, and facilitating the reimbursement of those services; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance

 

S.2536 – A bill to require the Secretary of Agriculture to provide training materials for the use of health care professionals to inform their patients about the availability of benefits under the supplemental nutrition assistance program, and for other purposes; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Agriculture, Nutrition, and Forestry

 

S.2538 – A bill to authorize the Secretary of Health and Human Services to award grants to regional biocontainment laboratories for maintaining surge capacity for purposes of responding to outbreaks of infectious diseases or acts of bioterrorism; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2539 – A bill to clarify that, in awarding funding under title X of the Public Health Service Act, the Secretary of Health and Human Services may not discriminate against eligible States, individuals, or other entities for refusing to counsel or refer for abortions; Sponsor: Lankford, James [Sen.-R-OK]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2544 – A bill to amend the Public Health Service Act to improve reproductive health care of individuals with disabilities; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.4895 – To amend title XI of the Social Security Act to expand the drug price negotiation program, and for other purposes; Sponsor: Pallone, Frank, Jr. [Rep.-D-NJ-6]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.4901 – To amend the Public Health Service Act to improve reproductive health care of individuals with disabilities; Sponsor: Bush, Cori [Rep.-D-MO-1]; Committees: House – Energy and Commerce

 

H.R.4905 – To amend the Internal Revenue Code of 1986, the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 to promote group health plan price transparency; Sponsor: Fitzpatrick, Brian K. [Rep.-R- PA-1]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means

 

H.R.4911 – To provide for the establishment of a pilot program to provide grants to community mental health centers for the placement of social workers with law enforcement agencies, and for other purposes; Sponsor: Harder, Josh [Rep.-D- CA-9]; Committees: House – Judiciary

 

H.R.4914 – To provide for research and improvement of cardiovascular health among the South Asian population of the United States, and for other purposes; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Energy and Commerce

 

H.R.4917 – To amend title XVIII of the Social Security Act to provide no-cost coverage for PFAS testing under the Medicare program; Sponsor: Kildee, Daniel T. [Rep.-D-MI-8]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4918 – To authorize the Secretary of Health and Human Services to provide grants to medical and other health profession schools to expand or develop education and training programs for substance use prevention and treatment, and for other purposes; Sponsor: Kim, Andy [Rep.-D-NJ-3]; Committees: House – Energy and Commerce

 

H.R.4930 – To provide grants for the conduct of demonstration projects designed to provide education and training for eligible individuals to enter and follow a career pathway in the field of pregnancy, childbirth, or post-partum, under the health profession opportunity grant program under section 2008 of the Social Security Act; Sponsor: Moore, Gwen [Rep.- D-WI-4]; Committees: House – Ways and Means

 

H.R.4933 – To amend the Public Health Service Act to modify the loan repayment program for the substance use disorder treatment workforce to relieve workforce shortages; Sponsor: Napolitano, Grace F. [Rep.-D-CA-31]; Committees: House – Energy and Commerce

 

H.R.4941 – To amend title V of the Public Health Service Act to establish within the Substance Abuse and Mental Health Services Administration a Center for Unhoused Individuals, and for other purposes; Sponsor: Schiff, Adam B. [Rep.-D- CA-30]; Committees: House – Energy and Commerce

 

H.R.4942 – To provide incentives to physicians to practice in rural and medically underserved communities, and for other purposes; Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]; Committees: House – Judiciary

 

H.R.4946 – To amend title XVIII of the Social Security Act to eliminate the 190-day lifetime limit on inpatient psychiatric hospital services under the Medicare Program; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Ways and Means

 

H.R.4950 – To amend title XIX of the Social Security Act to encourage appropriate prescribing under Medicaid for victims of opioid overdose; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Energy and Commerce

 

S.Res.319 – A resolution declaring racism a public health crisis; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.323 – A resolution supporting the goals and ideals of Fentanyl Prevention and Awareness Day on August 21, 2023; Sponsor: Grassley, Chuck [Sen.-R-IA]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.2556 – A bill to amend title XIX of the Social Security Act to ensure Medicaid coverage of mental health services and primary care services furnished on the same day; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

 

S.2559 – A bill to amend the Internal Revenue Code of 1986 to establish a stewardship fee on the production and importation of opioid pain relievers, and for other purposes; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Finance

 

S.2560 – A bill to address and support research on Long COVID; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2569 – A bill to amend the Controlled Substances Act to clarify that the possession, sale, purchase, importation, exportation, or transportation of drug testing equipment that tests for the presence of fentanyl or xylazine is not unlawful; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Judiciary

 

S.2580 – A bill to support programs for mosquito-borne and other vector-borne disease surveillance and control; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2584 – A bill to establish a commission on long-term care; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2586 – A bill to address prescription drug shortages and improve the quality of prescription drugs, and for other purposes; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2590 – A bill to amend the Public Health Service Act to provide additional funding for the Commissioned Corps of the Public Health Service; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2602 – A bill to limit the scope of regulations issued by the Secretary of Health and Human Services to control communicable diseases, and for other purposes; Sponsor: Paul, Rand [Sen.-R-KY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2617 – A bill to prohibit the Secretary of Health and Human Services from restricting direct access by health care facilities to medical countermeasures; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2621 – A bill to amend the Internal Revenue Code of 1986 to expand and improve health savings accounts, and for other purposes; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Finance

 

S.2622 – A bill to clarify the application of the appointment and confirmation requirements for the Director of the Centers for Disease Control and Prevention; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2624 – An original bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2024, and for other purposes; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Appropriations

 

S.2638 – A bill to authorize the Secretary of Health and Human Services to build safer, thriving communities, and save lives, by investing in effective community-based violence reduction initiatives, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Judiciary

 

S.2639 – A bill to amend the Public Health Service Act to require the Secretary of Health and Human Services to carry out activities to establish, expand, and sustain a public health nursing workforce, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2644 – A bill to establish standards for trauma kits purchased using funds provided under the Edward Byrne Memorial Justice Assistance Grant Program; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Judiciary

 

S.2645 – A bill to reduce the health risks of heat by establishing the National Integrated Heat Health Information System within the National Oceanic and Atmospheric Administration and the National Integrated Heat Health Information System Interagency Committee to improve extreme heat preparedness, planning, and response, requiring a study, and establishing financial assistance programs to address heat effects, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Commerce, Science, and Transportation

 

S.2646 – A bill to expand access to health care services for immigrants by removing legal and policy barriers to health insurance coverage, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Finance

 

S.2647 – A bill to improve research and data collection on stillbirths, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2649 – A bill to improve community care provided by the Department of Veterans Affairs, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans’ Affairs

 

S.2650 – A bill to establish a Commission on the Federal Regulation of Cannabis to study a prompt and plausible pathway to the Federal regulation of cannabis, and for other purposes; Sponsor: Hickenlooper, John W. [Sen.-D-CO]; Committees: Senate – Judiciary

 

S.2657 – A bill to provide for green and resilient health care infrastructure, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2665 – A bill to require the Secretary of Defense to provide to firefighters of the Department of Defense medical testing and related services to detect and prevent certain cancers; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Armed Services

 

S.2666 – A bill to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2672 – A bill to require the Secretary of Health and Human Services to develop a strategic framework to improve the development and distribution of diagnostic tests in response to chemical, biological, radiological, or nuclear threats; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2683 – A bill to establish requirements for purchasing certain generic drugs from manufacturers who produce the drug domestically; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2684 – A bill to amend title XI of the Social Security Act to require the Secretary of Health and Human Services to verify whether a health care provider is licensed in good standing before issuing the provider a unique health identifier, and for other purposes; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Finance

 

S.2686 – A bill to require the Comptroller General of the United States to conduct a study on the economic impact and health outcomes associated with the response to the COVID-19 pandemic in the United States; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2688 – A bill to amend the Public Health Service Act to extend health information technology assistance eligibility to behavioral health, mental health, and substance abuse professionals and facilities, and for other purposes; Sponsor: Mullin, Markwayne [Sen.-R-OK]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2699 – A bill to combat the fentanyl crisis; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2714 – A bill to establish the National Artificial Intelligence Research Resource, and for other purposes; Sponsor: Heinrich, Martin [Sen.-D-NM]; Committees: Senate – Commerce, Science, and Transportation

 

H.Res.632 – Recognizing July 28, 2023, as “World Hepatitis Day”; Sponsor: Velazquez, Nydia M. [Rep.-D-NY-7]; Committees: House – Energy and Commerce

 

H.R.4953 – To reduce the health risks of heat by establishing the National Integrated Heat Health Information System within the National Oceanic and Atmospheric Administration and the National Integrated Heat Health Information System Interagency Committee to improve extreme heat preparedness, planning, and response, requiring a study, and establishing financial assistance programs to address heat effects, and for other purposes; Sponsor: Bonamici, Suzanne [Rep.-D-OR-1]; Committees: House – Energy and Commerce; Science, Space, and Technology

 

H.R.4968 – To amend title XVIII of the Social Security Act to exempt qualifying physicians from prior authorization requirements under Medicare Advantage plans, and for other purposes; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.4975 – To establish a grant to provide mental and behavioral health services and diversion programs to at-risk youth, and for other purposes; Sponsor: Cárdenas, Tony [Rep.-D-CA-29]; Committees: House – Judiciary

 

H.R.4985 – To establish a grant program to support schools of medicine and schools of osteopathic medicine in underserved areas; Sponsor: Costa, Jim [Rep.-D-CA-21]; Committees: House – Energy and Commerce

 

H.R.4988 – To amend the Federal Food, Drug, and Cosmetic Act to modernize the methods of authenticating controlled substances in the pharmaceutical distribution supply chain, and for other purposes; Sponsor: Davis, Donald G. [Rep.-D- NC-1]; Committees: House – Energy and Commerce

 

H.R.5002 – To direct the Secretary of Veterans Affairs to carry out a pilot program for the cognitive care of veterans, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Veterans’ Affairs

 

H.R.5003 – To authorize the Secretary of Health and Human Services to build safer, thriving communities, and save lives, by investing in effective community-based violence reduction initiatives, and for other purposes; Sponsor: Horsford, Steven [Rep.-D-NV-4]; Committees: House – Judiciary; Education and the Workforce

 

H.R.5007 – To provide for green and resilient health care infrastructure, and for other purposes; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Energy and Commerce

 

H.R.5008 – To expand access to health care services for immigrants by removing legal and policy barriers to health insurance coverage, and for other purposes; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.5010 – To require the Secretary of Health and Human Services, in coordination with the Director of the Centers for Disease Control and Prevention, to submit to the Congress an annual report on the effects of gun violence on public health; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Energy and Commerce

 

H.R.5012 – To improve research and data collection on stillbirths, and for other purposes; Sponsor: Kim, Young [Rep.-R- CA-40]; Committees: House – Energy and Commerce

 

H.R.5013 – To direct the Secretary of Health and Human Services to revise certain regulations in relation to the Medicare shared savings program and other alternative payment arrangements to encourage participation in such program, and for other purposes; Sponsor: LaHood, Darin [Rep.-R-IL-16]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5027 – To improve the understanding of, and promote access to treatment for, chronic kidney disease, and for other purposes; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.5066 – To amend the Public Health Service Act to authorize grants to evaluate, develop, and expand the use of technology-enabled collaborative learning and capacity building models to improve maternal health outcomes, and for other purposes; Sponsor: Williams, Nikema [Rep.-D-GA-5]; Committees: House – Energy and Commerce

The House Appropriations Committee released its Labor-Health and Human Services-Education appropriations bill for fiscal year (FY) 2024 and advanced the package out of subcommittee last week. The bill would cut topline spending levels by 29%, with the U.S. Department of Health and Human Services (HHS) receiving a total of $103.3 billion – $14 billion less than current levels. Funding for the Centers for Disease Control and Prevention would be cut by $1.6 billion, funding for the National Institutions of Health would be cut by $3.8 billion, and funding for the Advanced Research Projects Agency for Health would be cut by $1 billion. Appropriations for the Agency for Healthcare Research and Quality would be eliminated altogether, with appropriators arguing the agency is duplicative of other HHS programs. Title X family planning grants would also be eliminated. The bill includes several contentious policy riders, including a requirement that HHS report to Congress how many abortions are provided under exceptions to the Hyde Amendment. The Senate Appropriations Committee is reportedly planning to mark up its own Labor-HHS-Education appropriations bill on July 27.

The House Appropriations Committee also approved its FY 2024 State and Foreign Operations appropriations bill last week. The bill includes a total of $1.5 billion for USAID, an approximately $500 million cut, and would extend authorization for the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for one year. It includes a provision to prevent the administration from entering any international agreement via the World Health Assembly without two-thirds Senate approval. It also includes several abortion- related riders, including the Helms amendment restriction on the use of global health funds to pay for abortions and the Mexico City Policy barring support for organizations that perform or promote abortions. The Senate Appropriations Committee is scheduled to markup its FY 2024 State and Foreign Operations appropriations bill on July 20.

 

Education Workforce Panel Considers Health Transparency Measures

The House Education and Workforce Committee advanced four bipartisan health care transparency measures out of committee last week. The bills approved by the panel include:

• H.R. 4509, the Transparency in Billing Act, which would require accurate billing practices by hospitals to ensure that group health plans pay for appropriately billed services.
• H.R. 4507, the Transparency in Coverage Act, to codify the “Transparency in Coverage” final rule, which provides consumers with price transparency for medical services and prescription drugs.
• H.R. 4527, the Health DATA Act, to ensure health plan fiduciaries are not contractually restricted from receiving cost or quality of care information about their plan.
• H.R. 4508, the Hidden Fee Disclosure Act, which would strengthen requirements that pharmacy benefit managers and Third-Party Administrators disclose compensation to plan fiduciaries.

 

Finance Committee to Markup PBM Package

The Senate Finance Committee has scheduled a July 26 markup of legislative proposals to increase transparency and accountability in the pharmacy benefit manager (PBM) industry. While it remains unclear what legislation the package will contain, it is expected to build on the roadmap released by Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) in April outlining the types of bipartisan solutions they wished to pursue. The Chairman’s Mark will be released 48 hours in advance of the markup.

 

Senate Democrats Release Report on Generic Insulin Access

Senate Democrats released a report last week shedding light on the accessibility of generic insulin products. The report, which was prepared by the offices of Sens. Richard Blumenthal (D-Conn.), Elizabeth Warren (D-Mass.), and Raphael Warnock (D-Ga.), found that while nearly half of the 300 pharmacies surveyed did not have Eli Lilly’s generic insulin Lispro in stock, 80% of those pharmacies had the more expensive brand product Humalog available. The average price of Lispro for uninsured individuals totaled $97.51, more than triple the advertised list price. The three major manufacturers of insulin – Eli Lilly, Novo Nordisk Inc., and Sanofi – publicly committed to limiting patient costs for generic insulin to $25 per vial earlier this year. Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sander (I-Vt.) met with Senate Majority Leader Chuck Schumer (D-N.Y.) to discuss the issue last week. Schumer has stated his intention to advance bipartisan legislation to lower the cost of insulin and prescription drugs during the chamber’s current work period.

 

Cassidy Releases Proposal to Reauthorize Key Health Programs

Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-La.) has introduced legislation to reauthorize community health centers and several other public health programs. Cassidy’s proposal, which mirrors the bipartisan bill advanced by the House Energy and Commerce Committee, would offer small increases in funding for community health centers, the National Health Service Corps (NHSC), and the Teaching Health Center Graduate Medical Education (THCGME) Program. It stands in contrast to HELP Chairman Bernie Sander’s (I-Vt.) plan, which included significant funding increases. Authorization for the programs is set to expire at the end of the fiscal year on September 30. Cassidy’s Community Health Center Reauthorization Act would extend and increase funding for community health centers at $4.2 billion a year for the next two years. The Community Health Center Fund currently receives $4 billion in federal funding annually. The NHSC would be funded at $350 million for two years, an increase of $40 million per year. Funding for the THCGME program would increase from $175 million to $275 million over six years.

 

Senate Judiciary Advances Rogue Pharmacy Legislation

The Senate Judiciary Committee advanced bipartisan legislation last week to require social media companies and digital communication service providers to report to the Drug Enforcement Administration when their platforms are used by rogue pharmacies or drug dealers to illegally sell or distribute drugs. S. 1080, the Cooper Davis Act, was advanced in a 16-5 vote. The bill is named in honor of a 16-year-old teenager who died after taking a counterfeit prescription drug laced with fentanyl in August 2021. It was later discovered that a drug dealer solicited the teenager via Snapchat.

 

E&C GOP Investigation NIH Reappointments

Republican leadership of the House Energy and Commerce Committee are investigating the process surrounding the appointment of 14 National Institutes of Health (NIH) officials, including former National Institutes of Allergy and Infectious Diseases Director Anthony Fauci. The lawmakers assert that the individuals were not correctly reappointed to their positions in late 2021, calling into question the legality of the more than $25 billion in research grants they approved. While NIH center and institute leaders are permitted to serve multiple five-year terms, the 21st Century Cures Act requires the U.S. Department of Health and Human Services Secretary to personally handle such appointments. Chair Cathy McMorris Rodgers (R-Wash.) asserts that in the case of the 14 NIH leaders, reappointments were made by the NIH director and later ratified by Secretary Xavier Becerra. According to committee staff, the panel plans to continue pressing the issue with administration officials and are considering the need for legislation to clarify the appointment process.

 

Nomination for NIH Director Remains Stalled Before HELP Committee

Dr. Monica Bertagnolli, the White House’s nominee to lead the National Institutes of Health (NIH), has declined Sen. Elizabeth Warren’s (D-Mass.) request to make a public ethics pledge committing to not seek employment in an industry related to her government post for at least four years after leaving public service. Bertagnolli’s nomination also faces a hurdle from Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-Vt.), who has said he will oppose all administration health nominees who do not commit to working to lower drug prices. Bertagnolli reportedly has concerns about the scope of each commitment, and left a meeting with Warren last week without reaching an agreement. The NIH has been without a confirmed director for a year and a half, but administration officials have stated that they remain committed to Bertagnolli’s confirmation.

 

GAO Updates PHE Preparedness Recommendations

The Government Accountability Office (GAO) has released a new report containing additional recommendations for federal agencies to better prepare for future public health emergencies (PHE). As of April 2023, the GAO has made 386 recommendations to 26 federal agencies and 19 suggestions to Congress to strengthen response and preparedness. About 45% of those have been fully or partially addressed. GAO’s latest recommendations focus on access to diagnostic testing and medical countermeasures, access to real-time information about emerging threats, and the risk of improper payments and fraud.

 

Upcoming Congressional Hearings and Markups

House Energy and Commerce Subcommittee on Health hearing “Innovation Saves Lives: Evaluating Medicare Coverage Pathways for Innovative Drugs, Medical Devices, and Technology;” 10:30 a.m.; July 18

 

House Oversight and Accountability Subcommittee on Health Care and Financial Services hearing “Why Expanding Medicaid to DACA Recipients Will Exacerbate the Border Crisis;” 2:00 p.m.; July 18

 

House Small Business Subcommittee on Oversight, Investigations, and Regulations hearing “Burdensome Red Tape: Overregulation in Health Care and the Impact on Small Businesses;” 10:00 a.m.; July 19

 

Joint Economic Committee hearing to examine the economic impact of diabetes; 2:00 p.m.; July 19

 

Senate Homeland Security and Governmental Affairs Committee hearing to examine America’s supply chain security, focusing on understanding and mitigating threats; 10:00 a.m.; July 20

 

Senate Finance Subcommittee on Health hearing “The Cost of Inaction and the Urgent Need to Reform the U.S. Transplant System;” 10:00 a.m.; July 20

 

Senate Health, Education, Labor, and Pensions Committee markup of S. ___, Pandemic and All-Hazards Preparedness and Response Act; 10:30 a.m.; July 20

 

Senate Appropriations Committee markup of FY 2024 State and Foreign Operations, Energy and Water Development, Housing, and Urban Development; 10:30 a.m.; July 20

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

H.R.4507 – To amend the Employee Retirement Income Security Act of 1974 to promote transparency in health coverage and reform pharmacy benefit management services with respect to group health plans, and for other purposes; Sponsor: Good, Bob [Rep.-R-VA-5]; Committees: House – Education and the Workforce; Energy and Commerce; Ways and Means

 

H.R.4508 – To amend the Employee Retirement Income Security Act of 1974 to clarify and strengthen the application of certain employer-sponsored health plan disclosure requirements; Sponsor: Courtney, Joe [Rep.-D-CT-2]; Committees: House – Education and the Workforce

 

H.R.4509 – To amend the Employee Retirement Income Security Act of 1974 to require group health plans and health insurance issuers offering group health insurance coverage to only pay claims submitted by hospitals that have in place policies and procedures to ensure accurate billing practices, and for other purposes. Sponsor: Foxx, Virginia [Rep.-R- NC-5]; Committees: House – Education and the Workforce

 

H.R.4516 – To amend the Public Health Service Act to provide for the inclusion of a biological attribution strategy, and an early warning strategy and implementation plan, in the National Health Security Strategy, and for other purposes. Sponsor: Crenshaw, Dan [Rep.-R-TX-2]; Committees: House – Energy and Commerce

 

H.R.4518 – To amend title 38, United States Code, to modify the program of comprehensive assistance for family caregivers of veterans, and for other purposes. Sponsor: Davis, Donald G. [Rep.-D-NC-1]; Committees: House – Veterans’ Affairs

 

H.R.4525 – To provide an individual with an eligible medical condition access to an employee restroom facilities of a retail establishment under certain conditions, and for other purposes. Sponsor: Norton, Eleanor Holmes [Del.-D-DC-At Large]; Committees: House – Energy and Commerce

 

S.2231 – A bill to amend title V of the Social Security Act to support stillbirth prevention and research, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Finance

 

S.2237 – A bill to amend the Public Health Service Act to require the Secretary to award grants, contracts, or cooperative agreements to eligible entities to establish, maintain, or improve activities related to the detection and monitoring of infectious diseases through wastewater for public health emergency preparedness and response purposes, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2239 – A bill to prevent maternal mortality and severe maternal morbidity among Black pregnant and postpartum individuals and other underserved populations, to provide training in respectful maternity care, to reduce and prevent bias, racism, and discrimination in maternity care settings, and for other purposes; Sponsor: Warnock, Raphael G. [Sen.-D-GA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2243 – A bill to amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools and other programs, including social work, physician assistant, and chaplaincy education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative and hospice care; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2245 – A bill to require a review of women and lung cancer, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2246 – A bill to authorize the appropriation of funds to the National Institutes of Health and the Centers for Disease Control and Prevention for conducting or supporting research on barriers to gender affirming care; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.4527 – To amend the Employee Retirement Income Security Act of 1974 to ensure plan fiduciaries may access de- identified information relating to health claims, and for other purposes; Sponsor: Chavez-DeRemer, Lori [Rep.-R-OR-5]; Committees: House – Education and the Workforce

 

H.R.4529 – To amend the Public Health Service Act regarding guidance documents of the Centers for Disease Control and Prevention, and for other purposes; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce

 

H.R.4531 – To reauthorize certain programs that provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Energy and Commerce; Judiciary; Education and the Workforce

 

H.R.4534 – To require a review of women and lung cancer, and for other purposes; Sponsor: Boyle, Brendan F. [Rep.-D- PA-2]; Committees: House – Energy and Commerce

 

H.R.4535 – To amend the Internal Revenue Code of 1986 to increase funding for Social Security and Medicare; Sponsor: Boyle, Brendan F. [Rep.-D-PA-2]; Committees: House – Ways and Means

 

H.R.4541 – To improve the identification and support of children and families who experience trauma; Sponsor: Davis, Danny K. [Rep.-D-IL-7]; Committees: House – Education and the Workforce; Energy and Commerce; Judiciary

 

S.2254 – A bill to amend title XVIII of the Social Security Act to establish pharmacy benefit manager reporting requirements with respect to prescription drug plans and MA-PD plans under Medicare part D; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Finance

 

S.2259 – A bill to require the Secretary of Veterans Affairs to carry out a pilot program to establish community integration network infrastructure for services for veterans, to require the collection from veterans of information related to social determinants of health, and for other purposes; Sponsor: Sullivan, Dan [Sen.-R-AK]; Committees: Senate – Veterans’ Affairs

 

S.2263 – A bill to require the Secretary of Veterans Affairs to reimburse the cost of transportation by ambulance for highly rural veterans seeking care under the laws administered by the Secretary, regardless of whether such veteran qualifies for payments or allowances for beneficiary travel; Sponsor: Sullivan, Dan [Sen.-R-AK]; Committees: Senate – Veterans’ Affairs

 

H.R.4572 – To provide for research and education with respect to uterine fibroids, and for other purposes; Sponsor: Clarke, Yvette D. [Rep.-D-NY-9]; Committees: House – Energy and Commerce

 

H.R.4581 – To amend title V of the Social Security Act to support stillbirth prevention and research, and for other purposes; Sponsor: Hinson, Ashley [Rep.-R-IA-2]; Committees: House – Energy and Commerce

 

H.R.4582 – To amend the Public Health Service Act to authorize the use of Preventive Health and Health Services Block Grants to purchase life-saving opioid antagonists for schools and to provide related training and education to students and teachers, and for other purposes; Sponsor: Lamborn, Doug [Rep.-R-CO-5]; Committees: House – Energy and Commerce

 

H.R.4585 – To amend title XIX of the Social Security Act to provide a higher Federal matching rate for increased expenditures under Medicaid for maternal health care services; Sponsor: Manning, Kathy E. [Rep.-D-NC-6]; Committees: House – Energy and Commerce

 

S.2329 – A bill to establish an emerging pathogen preparedness program within the Food and Drug Administration to improve regulatory oversight of medical countermeasures for future pandemics. Sponsor: Hickenlooper, John W. [Sen.-D- CO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2323 – A bill to amend title XVIII of the Social Security Act to provide for expanded coverage of services furnished by genetic counselors under part B of the Medicare program, and for other purposes. Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance

 

S.2308 – A bill to extend funding for teaching health centers that operate GME programs, community health centers, and the National Health Service Corps. Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2305 – A bill to improve the requirements for making a determination of interchangeability of a biological product and its reference product. Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2304 – A bill to amend the Public Health Service Act to support dual or concurrent enrollment programs in allied health. Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2303 – A bill to provide for research and education with respect to uterine fibroids, and for other purposes. Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2300 – A bill to require that information on spending associated with national emergencies be subject to the same reporting requirements as other Federal funds under the Federal Funding Accountability and Transparency Act of 2006, and for other purposes. Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Homeland Security and Governmental Affairs

 

33. S.2297 – A bill to improve the provision of benefits and services to members of the Ready Reserve Corps of the Public Health Service, and for other purposes. Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2294 – A bill to amend title 38, United States Code, to furnish hospital care and medical services to veterans and dependents who were stationed at military installations at which those veterans and dependents were exposed to perfluorooctanoic acid or other perfluoroalkyl and polyfluoroalkyl substances, to provide for a presumption of service connection for certain veterans who were stationed at military installations at which those veterans were exposed to such substances, and for other purposes. Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Veterans’ Affairs

 

S.2293 – A bill to establish the Chief Artificial Intelligence Officers Council, Chief Artificial Intelligence Officers, and Artificial Intelligence Governance Boards, and for other purposes. Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Homeland Security and Governmental Affairs

 

S.2288 – A bill to amend title XVIII of the Social Security Act to provide coverage of medically necessary home resiliency services under Medicare. Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Finance

 

S.Res.294 – A resolution expressing support for the designation of May 2023 as “American Stroke Month”. Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.4599 – To provide for the Secretary of Health and Human Services to establish grant programs to improve the health and positive youth development impacts of youth sports participation, and for other purposes; Sponsor: Allred, Colin Z. [Rep.-D-TX-32]; Committees: House – Education and the Workforce; Energy and Commerce

 

H.R.4603 – To provide for the prioritization of projects that provide behavioral and mental health treatment services in selecting grantees under certain rural development programs, and extend the substance abuse disorder set-aside and priority under the programs; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Agriculture

 

H.R.4605 – To amend titles XIX and XXI of the Social Security Act to improve maternal health coverage under Medicaid and CHIP, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4623 – To establish a voluntary program to identify and promote internet-connected products that meet industry- leading cybersecurity and data security standards, guidelines, best practices, methodologies, procedures, and processes, and for other purposes; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Energy and Commerce

 

H.R.4626 – To encourage sponsors of oral contraceptive drugs to submit applications for the approval of such drugs as over-the-counter, and for other purposes; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Energy and Commerce

President Joe Biden announced a series of new administration initiatives aimed at lowering health care costs and strengthening patient protections on Friday. The announcements were the latest in a series of actions by the administration to push the President’s “Bidenomics” agenda and eliminate hidden junk fees. Friday’s releases included new proposed rules to reverse the Trump administration’s expansion of short-term, limited duration health plans. Democrats argue that such “junk” plans undermine the patient protections put in place by the Affordable Care Act. The new regulations would limit these plans to four months, instead of the current three-year maximum, and would require more disclosure around coverage limitations. The administration also released guidance intended to prevent health care providers from gaming the No Surprises Act’s regulations around surprise medical billing. The guidance would specifically limit the ability of insurers that contract with hospitals to claim provided care was not in network. It would also require insurers to disclose facility fees that are charged to patients. Finally, the administration announced a new effort being undertaken by the Consumer Financial Protection Bureau, the U.S. Department of Health and Human Services, and the Treasury Department to examine whether health care provider and third-party efforts to encourage consumers to sign up for medical credit cards and loans are operating outside of existing consumer protections and breaking the law.

 

Schumer Sends Dear Colleague on July Work Period

In a Dear Colleague letter on Sunday, Senate Majority Leader Chuck Schumer (D-N.Y.) previewed his agenda for the chamber’s upcoming work period following lawmakers’ return from the July 4th recess on Monday. In addition to considering bipartisan appropriations bills through regular order, Schumer hopes to advance bipartisan legislation to lower the cost of insulin and prescription drugs, combat the fentanyl crisis, and promote community health. He also announced his intention to build on his SAFE Innovation Framework for Artificial Intelligence (AI), which outlines how the Senate can advance American leadership in AI and harness its potential while protecting against potential harms. The Senate’s summer recess is currently scheduled to begin on July 31.

 

HELP Releases Bipartisan PAHPA Discussion Draft

Chair and Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee Bernie Sanders (I-Vt.) and Bill Cassidy (R-La.) released a staff-level agreement on a package to reauthorize the Pandemic and All- Hazards Preparedness Act (PAHPA) last week. While the lawmakers were able to reach a deal on much of the discussion draft to extend PAHPA authorities for five years, differences remain on several prescription drug pricing and drug development voucher provisions. Democrats are pushing to cap the cost of any product developed with the support of the Centers for Disease Control and Prevention or the Biomedical Advanced Research and Development Authority at the lowest price among G7 countries – U.S., U.K, Canada, France, Germany, Italy, and Japan. Republicans are seeking the reauthorization and expansion of the priority review voucher program at the Food and Drug Administration. The GOP proposal aims to incentivize the development of more medical countermeasures (MCMs) by providing a new, non- transferrable priority review voucher to companies that develop new MCMs on top of the transferrable voucher they currently receive, and by including threats to the Armed Forces within the program. HELP leadership sought feedback on their plan and the policies still under negotiation by July 10. Authorization for PAHPA’s public health programs expires on September 30.

 

CMS Proposes 340B Remedy Following Supreme Court Decision

The Centers for Medicare and Medicaid Services (CMS) is proposing to provide hospitals participating in the 340B drug program with $9 billion as compensation for $10.5 billion in payment cuts dating back to 2018. CMS states that the higher payment rate for 340B hospitals that has been in place since 2022 will cover the remaining $1.5 billion. The Supreme Court ruled last year that cuts made to the 340B program by the U.S. Department of Health and Human Services – aimed at increasing payment accuracy and addressing hospital overspending – were unlawful because CMS did not fully survey the impacted hospitals’ costs for acquiring 340B-eligible drugs. The proposed rule released last week outlines a plan to distribute the money to the approximately 1,600 hospitals that were paid less due to the now-invalidated policy. The proposed lump sum approach would involve Medicare administrative contractors calculating how much each hospital will receive within 60 days, along with a 0.5% cut to non-drug items and services for all hospitals to keep the resolution budget neutral.

 

FDA Fully Approves Leqembi

The Food and Drug Administration (FDA) has granted full approval to the Alzheimer’s treatment Leqembi. The drug has been shown to modestly slow cognitive decline in the early stages of Alzheimer’s disease, but also comes with potentially life-threatening side effects. It is the first drug for slowing the progression of Alzheimer’s – and not just targeting its symptoms – to be granted full FDA approval. In its phase three clinical trial of 1,795 patients with mild cognitive impairment or early-stage Alzheimer’s, disease progression was slowed by 27% over an 18-month period. The FDA’s approval includes a boxed warning about the potential for brain swelling and hemorrhage, which can lead to seizures and death. Approximately 12.6 % of patients who received Leqembi in the clinical trial developed brain swelling, compared with 1.7% of those in the placebo group, and around 17% of the Leqembi group experienced brain bleeds, versus 9% in the placebo group. Three deaths have been linked to the drug. Leqembi is administered intravenously every two weeks and will carry a list price of $26,500 per year. Following the FDA’s approval of the drug, the Centers for Medicare and Medicaid Services (CMS) confirmed that it would provide coverage of Leqembi under the Medicare program. In keeping with its previously announced policy, CMS will mandate that physicians collect real-world evidence on the performance of the treatment through participation in a qualifying CMS-facilitated registry.

 

U.S. Maternal Mortality Rates Continue to Rise

U.S. maternal mortality rates have doubled over the last decade according to a new study published in the Journal of the American Medical Association last week. The estimated number of deaths per 100,000 live births increased from 12.7 deaths in 1999 to 32.2 deaths in 2019. States in the south saw the highest maternal death rates across all race and ethnicity groups, and black women had the highest median maternal death rate.

 

Upcoming Congressional Hearings and Markups

Senate HELP Subcommittee on Primary Health & Retirement Security hearing “Superbugs: The Impact of Antimicrobial Resistance on Modern Medicine;” 10:00 a.m.; July 11

 

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Investigating the Proximal Origin of a Cover Up;” 10:00 a.m.; July 11

 

Senate Appropriations Committee hearing “Accelerating Breakthroughs: How the Special Diabetes Program Is Creating Hope for those Living with Type 1 Diabetes;” 10:00 a.m.; July 11

 

Senate Judiciary Subcommittee on Intellectual Property hearing “Artificial Intelligence and Intellectual Property – Part II: Copyright;” 3:00 p.m.; July 12

 

House Small Business Subcommittee on Oversight, Investigations, and Regulations hearing “Burdensome Red Tape: Overregulation in Health Care and the Impact on Small Businesses;” 10:00 a.m.; July 19

 

Recently Introduced Health Legislation

H.Res.564 – Supporting the goals and ideals of Alzheimer’s and Brain Awareness Month. Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; Committees: House – Energy and Commerce

 

H.Res.572 – Expressing support for the designation of the month of June 2023 as “National Post-Traumatic Stress Injury Awareness Month” and June 27, 2023, as “National Post-Traumatic Stress Injury Awareness Day”. Sponsor: Peters, Scott H. [Rep.-D-CA-50]; Committees: House – Armed Services; Veterans’ Affairs

 

H.R.4395 – To amend the Energy Policy and Conservation Act to modify standards for water heaters, furnaces, boilers, and kitchen cooktops, ranges, and ovens, and for other purposes. Sponsor: Bice, Stephanie I. [Rep.-R-OK-5]; Committees: House – Energy and Commerce

 

H.R.4400 – To direct the Secretary of Veterans Affairs to conduct an independent review of the deaths of certain veterans by suicide, and for other purposes. Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Veterans’ Affairs

 

H.R.4402 – To amend title XI of the Social Security Act to clarify manufacturer transparency reporting requirements for certain transfers used for educational purposes. Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4408 – To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes. Sponsor: Gallagher, Mike [Rep.-R-WI-8]; Committees: House – Energy and Commerce

 

H.R.4410 – To amend title XVIII of the Social Security Act to make the Medicare Savings Program available in all jurisdictions. Sponsor: González-Colón, Jenniffer [Resident Commissioner-R-PR-At Large]; Committees: House – Energy and Commerce

 

H.R.4411 – To amend title XVIII of the Social Security Act to establish a floor in Medicare Advantage benchmark rates for regions with low Medicare fee-for-service penetration. Sponsor: González-Colón, Jenniffer [Resident Commissioner-R-PR- At Large]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.4412 – To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to award grants to States to implement a tick identification pilot program. Sponsor: Gottheimer, Josh [Rep.-D-NJ-5]; Committees: House – Energy and Commerce

 

H.R.4413 – To provide for the issuance of a Lyme Disease Research Semipostal Stamp. Sponsor: Gottheimer, Josh [Rep.- D-NJ-5]; Committees: House – Oversight and Accountability; Energy and Commerce

 

H.R.4414 – To amend title X of the Public Health Service Act to prohibit requiring a recipient or subrecipient of funds to provide referrals for abortion, and for other purposes. Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House – Energy and Commerce

 

H.R.4418 – To amend title 10, United States Code, to repeal the restriction on the use of funds and facilities of the Department of Defense for abortion care. Sponsor: Houlahan, Chrissy [Rep.-D-PA-6]; Committees: House – Armed Services

 

H.R.4419 – To amend the Public Health Service Act with respect to the Public Health Emergency Medical Countermeasures Enterprise, and for other purposes. Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation Contd.

H.R.4420 – To reauthorize certain programs under the Public Health Service Act with respect to public health security and all-hazards preparedness and response related to the Centers for Disease Control and Protection, and for other purposes. Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce

 

H.R.4421 – To reauthorize certain programs under the Public Health Service Act with respect to public health security and all-hazards preparedness and response related to the Administration for Strategic Preparedness and Response, and for other purposes. Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce

 

H.R.4424 – To direct the Secretary of Veterans Affairs to study and report on the prevalence of cholangiocarcinoma in veterans who served in the Vietnam theater of operations during the Vietnam era, and for other purposes. Sponsor: LaLota, Nick [Rep.-R-NY-1]; Committees: House – Veterans’ Affairs

 

H.R.4431 – To amend the Omnibus Crime Control and Safe Streets Act of 1968 to provide for a pilot program under the Comprehensive Opioid Abuse Grant Program for local law enforcement agencies located in rural areas to purchase naloxone to prevent and reduce opioid overdose deaths, and for other purposes. Sponsor: Newhouse, Dan [Rep.-R-WA-4]; Committees: House – Judiciary

 

H.R.4438 – To amend title XVIII of the Social Security Act to provide for coverage and payment of Alpha-1 Antitrypsin Deficiency Disorder treatment under part B of such title, and for other purposes. Sponsor: Salazar, Maria Elvira [Rep.-R- FL-27]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4449 – To establish the Commission on Strengthening the Domestic Pharmaceutical Supply Chain, and for other purposes. Sponsor: Torres, Ritchie [Rep.-D-NY-15]; Committees: House – Energy and Commerce

 

H.R.4458 – To amend title III of the Public Health Service Act to provide for clarity with respect to the duration of contracts for procurement of supplies for the Strategic National Stockpile, and for other purposes. Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce

 

H.R.4459 – To amend title III of the Public Health Service Act to specify the duration of contracts, grants, cooperative agreements, or other transactions awarded or entered into with the Biomedical Advanced Research and Development Authority, and for other purposes. Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce

 

H.R.4473 – To amend title XVIII of the Social Security Act to provide for site neutral payment for cancer care services under part B of the Medicare program; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4489 – To amend the 21st Century Cures Act to clarify that grants for State and Tribal response to opioid use disorders may, at the discretion of the Secretary of Health and Human Services, also be used to address associated health conditions, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Energy and Commerce

 

H.R.4490 – To amend the Controlled Substances Act to authorize pharmacies to deliver certain controlled substances to an administering practitioner in lieu of delivering such substances to the to the ultimate user, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Energy and Commerce; Judiciary

 

H.R.4498 – To promote a 21st century artificial intelligence workforce; Sponsor: Soto, Darren [Rep.-D-FL-9]; Committees: House – Education and the Workforce; Science, Space, and Technology

The House Energy and Commerce Subcommittee on Health plans to move forward with a markup of legislation to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) on July 13 despite an unresolved dispute over the exclusion of provisions to address the nation’s ongoing drug shortages in the must-pass package. On Friday, Rep. Richard Hudson (R-N.C.), a senior member of the House Energy and Commerce Committee who had taken the lead on soliciting stakeholder comments in preparation for the PAHPA reauthorization, introduced three separate bills (H.R. 4419, H.R. 4420, and H.R. 4421) which seek to reauthorize PAHPA-related programs. Democrats on the panel continue to push for the inclusion of drug shortage measures as a part of the reauthorization bill. Ranking Member Frank Pallone (D-N.J.) supports giving the Food and Drug Administration (FDA) new authorities to combat the shortages, arguing in a statement last week that the “initial PAHPA included a provision requiring FDA to prepare for shortage issues that might arise, and all previous reauthorizations have included FDA-related policy.” Republicans support a narrower reauthorization package, saying that it will ease the chances of passing a reauthorization bill before the current all-hazards and public health security programs expire on September 30. Committee Chair Cathy McMorris Rodgers (R-Wash.) is requesting information from stakeholders on current drug shortages as a separate matter, while Democrats are seeking assurance that any drug shortages bill be considered in must-pass legislation if it is not included in PAHPA reauthorization. Subcommittee Republicans are expected to attach a measure to reauthorize and expand the SUPPORT Act, passed in 2018 to combat the opioid crisis, as a part of the PAHPA reauthorization bill. According to Politico, lawmakers hope to then consider the reauthorization package before the full committee on either July 19 or July 27.

 

PEPFAR Reauthorization Complicated by Abortion Dispute

The issue of abortion is complicating congressional efforts to reauthorize the President’s Emergency Plan for AIDS Relief (PEPFAR). The program, created in 2003 under the George W. Bush administration, is credited with saving more than 25 million lives through its support of antiretroviral treatments and efforts to prevent HIV infections and strengthen health care systems across the globe. PEPFAR has historically enjoyed bipartisan support on Capitol Hill, but Democrats and Republicans are currently at odds about federal funding for HIV/AIDS prevention groups that also support access to abortion. Chair of the House Foreign Affairs Subcommittee on Global Health, Global Human Rights, and International Organizations Chris Smith (R-N.J.), who led the last PEPFAR reauthorization in 2018, has stated that he will not write another update for PEPFAR programs unless it includes a prohibition on funding for organizations that back abortion services. Democrats have characterized the inclusion of such a provision as a poison pill and argue that there is no evidence that PEPFAR funding has gone to providing or promoting abortion.

 

SCOTUS Issues Ruling Reversing Affirmative Action

The Supreme Court issued a decision last week to effectively end the use of affirmative action in the college admissions process. Justices ruled that these programs violate the Constitution’s equal protection clause, which bars racial discrimination by government entities. Justices Clarence Thomas, Samuel Alito, Neil Gorsuch, Brett Kavanaugh, and Amy Coney Barrett joined the majority opinion written by Chief Justice John Roberts. In response to the historic ruling, U.S. Department of Health and Human Services Secretary Xavier Becerra issued a statement highlighting the impact of the court’s decision on the health care workforce. Becerra argues that people of color have been historically excluded from attending medical school, noting that there is still a “significant deficit” in the number of Black and Latino doctors and medical students. “We need more health workers, especially those who look like and share the experiences of the people they serve,” Becerra stated. “This ruling will make it even more difficult for the nation’s colleges and universities to help create future health experts and workers that reflect the diversity of our great nation. The health and wellbeing of Americans will suffer as a result.”

 

CBO Releases Score of Telehealth Expansion Act

The Congressional Budget Office estimates that the Telehealth Expansion Act (S. 1001/H.R. 1843) has a 10-year price tag of $5.05 billion, driven by lost revenue from income and payroll taxes associated with increased contributions to Health Savings Accounts. The bill would permanently allow high-deductible health plans to offer telehealth before enrollees hit their deductible. Plans are currently only able to do so through the end of 2024 under a COVID-era statute. While the legislation, which was advanced by the House Ways and Means Committee earlier this year, has some bipartisan support, many Democrats have argued against strengthening high deductible health plans and undermining Affordable Care Act patient protections. Democrats have also raised concerns about the bill’s potential cost.

 

CMS Releases Final Drug Price Negotiation Guidance

The Centers for Medicare and Medicaid Services (CMS) released its revised guidance on Friday detailing the rules of the road for implementation of the Inflation Reduction Act’s “Medicare Drug Price Negotiation Program.” The final guidance relaxes the proposed requirement that pharmaceutical manufacturers not disclose information about price negotiations. It also removes the confidentiality policy’s data destruction requirements. These changes will result in the government no longer considering such materials as confidential.

 

ARPA-H Office Director Discusses Health Science Futures Work

The Advanced Research Projects Agency for Health’s (ARPA-H) Health Science Futures Director Amy Jenkins previewed her office’s work in an interview with Politico last week. In describing the foundational breakthroughs the Health Science Futures Office aims to accomplish, Jenkins stressed that the work of ARPA-H will be disease agnostic and will focus on developing, scaling, and applying different types of solutions to any disease state. She also discussed ARPA’s goal of de-risking innovation through the exploration of multiple approaches to a problem. Jenkins anticipates that ARPA-H will eventually have around 80 program managers that issue frequent research solicitations – once every year and a half – with 20 or more solicitations expected in the next calendar year. ARPA-H is currently soliciting research proposals for its first program, Novel Innovations for Tissue Regeneration in Osteoarthritis. Proposals are due on July 28, 2023.

 

HHS Releases Smoking Cessation Framework

The U.S. Department of Health and Human Services (HHS) released a draft framework last week to support and accelerate smoking cessation efforts. The framework is intended to serve as a roadmap for strengthening collaboration both amongst federal agencies and with nonfederal stakeholders. HHS highlights the framework as a part of the Biden administration’s Cancer Moonshot, which aims to reduce cancer mortality by 50% within 25 years. Smoking is the largest single driver of cancer mortality, causing approximately 30% of all cancer deaths. The draft framework is organized around six goals:

• Eliminate smoking-related and cessation-related disparities;
• Increase awareness and knowledge of smoking and cessation;
• Strengthen and sustain cessation services and supports;
• Increase access to and coverage of comprehensive, evidence-based cessation treatment;
• Expand public health surveillance of smoking and cessation behaviors and strengthen performance measurement and evaluation; and
• Promote ongoing and innovative research to support and accelerate smoking cessation.
• HHS is seeking public input on the framework by July 30.

 

Upcoming Congressional Hearings and Markups

Senate HELP Subcommittee on Primary Health & Retirement Security hearing “Superbugs: The Impact of Antimicrobial Resistance on Modern Medicine;” 10:00 a.m.; July 11

 

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Investigating the Proximal Origin of a Cover Up;” 10:00 a.m.; July 11

 

Senate Appropriations Committee hearing “Accelerating Breakthroughs: How the Special Diabetes Program Is Creating Hope for those Living with Type 1 Diabetes;” 10:00 a.m.; July 11

 

House Small Business Subcommittee on Oversight, Investigations, and Regulations hearing “Burdensome Red Tape: Overregulation in Health Care and the Impact on Small Businesses;” 10:00 a.m.; July 19

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

H.Res.550 – Expressing the sense of the House of Representatives regarding the Centers for Medicare & Medicaid Services developing a mobility metric to guide providers in preventing mobility loss among hospitalized older adults. Sponsor: Houchin, Erin [Rep.-R-IN-9]; Committees: House – Energy and Commerce

 

H.Res.555 – Recognizing the importance of intersectionality for abortion access. Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Energy and Commerce

 

H.R.4315 – To amend title XVIII of the Social Security Act to protect beneficiaries with limb loss and other orthopedic conditions by providing access to appropriate, safe, effective, patient-centered orthotic and prosthetic care; to reduce fraud, waste, and abuse with respect to orthotics and prosthetics; and for other purposes. Sponsor: Thompson, Glenn [Rep.-R- PA-15]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4324 – To amend the Federal Trade Commission Act to provide the Commission with notice and comment rulemaking authority respecting unfair or deceptive acts or practices and to provide for civil penalties for violations of such Act respecting unfair or deceptive acts or practices, and for other purposes. Sponsor: Castor, Kathy [Rep.-D-FL-14]; Committees: House – Energy and Commerce

 

H.R.4328 – To provide for establishment of the National Task Force on the Nursing Shortage. Sponsor: Costa, Jim [Rep.- D-CA-21]; Committees: House – Energy and Commerce

 

H.R.4329 – To provide enhanced funding for family planning services. Sponsor: Davids, Sharice [Rep.-D-KS-3]; Committees: House – Energy and Commerce

 

H.R.4330 – To amend title 18, United States Code, to require serial numbers to be engraved on ammunition, and for other purposes. Sponsor: Davis, Danny K. [Rep.-D-IL-7]; Committees: House – Judiciary

 

H.R.4331 – To amend title XIX of the Social Security Act to increase Federal Medicaid funding for States that provide intensive community-based services for adults with serious mental illness, and for other purposes. Sponsor: Goldman, Daniel S. [Rep.-D-NY-10]; Committees: House – Energy and Commerce

 

H.R.4334 – To amend chapter 171 of title 28, United States Code, to allow suit against the United States for injuries and deaths of members of the Armed Forces caused by improper medical care, and for other purposes. Sponsor: Issa, Darrell E. [Rep.-R-CA-48]; Committees: House – Judiciary

 

H.R.4339 – To amend title XIX of the Social Security Act to ensure enhanced Federal funding made available to States under the Medicaid program is equitably distributed to political subdivisions. Sponsor: Lawler, Michael [Rep.-R-NY-17]; Committees: House – Energy and Commerce

 

H.R.4343 – To amend the National Organ Transplant Act to clarify the definition of valuable consideration, to clarify that pilot programs that honor and promote organ donation do not violate that Act, and for other purposes. Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce

 

H.R.4345 – To protect the dignity of fetal remains, and for other purposes. Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House – Energy and Commerce

 

H.R.4347 – To amend title 18, United States Code, to provide increased penalties for mass killings involving machineguns or certain semiautomatic weapons, and for other purposes. Sponsor: Moulton, Seth [Rep.-D-MA-6]; Committees: House – Judiciary

 

H.R.4358 – To provide lawful permanent resident status and authorized dual intent for certain doctoral degree holders. Sponsor: Thanedar, Shri [Rep.-D-MI-13]; Committees: House – Judiciary

 

H.R.4363 – To address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor’s background, or forthcoming survivorship needs, and for other purposes. Sponsor: Wasserman Schultz, Debbie [Rep.-D-FL-25]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.Res.561 – Expressing opposition to the use of State power against people in the United States seeking essential health care, including criminalization of the full range of sexual and reproductive health care such as abortion, gender-affirming care, and contraceptive care, and disapproving of State punishment of people for their pregnancy outcomes; Sponsor: Williams, Nikema [Rep.-D-GA-5]; Committees: House – Energy and Commerce; Judiciary

 

H.R.4368 – Making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2024, and for other purposes; Sponsor: Harris, Andy [Rep.-R- MD-1]; Committees: House – Appropriations

 

H.R.4371 – To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, and in consultation with the Secretary of Education and the President’s Council on Fitness, Sports, and Nutrition, to conduct a study on the causes of deaths and catastrophic injuries related to high school and collegiate sports and formulate recommendations to prevent such deaths and catastrophic injuries, and for other purposes; Sponsor: Carter, Troy [Rep.-D-LA-2]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.4375 – To amend title XVIII of the Social Security Act to provide coverage of medically necessary home resiliency services under Medicare; Sponsor: Frost, Maxwell [Rep.-D-FL-10]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4381 – To amend the Public Health Service Act with respect to the determination, termination, and renewal of public health emergencies, and for other purposes; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce; Rules

 

H.R.4382 – To require the Secretary of Agriculture to conduct a study on the accessibility of addiction and mental health care providers and services for farmers and ranchers who have been impacted by severe and persistent drought, extreme weather events, instability in the commodities market, misinformation targeting consumers, and for other purposes; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Agriculture

 

H.R.4383 – To amend title 10, United States Code, to waive cost-sharing under the TRICARE program for three mental health outpatient visits per year for certain beneficiaries, and for other purposes; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Armed Services

 

H.R.4391 – To amend the Internal Revenue Code of 1986 to treat certain assisted reproduction expenses as medical expenses of the taxpayer; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Ways and Means

 

H.R.4392 – To increase access to pre-exposure prophylaxis to reduce the transmission of HIV; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Energy and Commerce; Oversight and Accountability; Ways and Means; Veterans’ Affairs; Armed Services; Natural Resources; Financial Services; Education and the Workforce

Before leaving for a two week recess, the House of Representatives passed the CHOICE Arrangement Act (H.R. 3799) by a 220-209 party-line vote. The bill would codify two Trump-era regulations intended to lower the cost of employer- sponsored health insurance. The first would allow companies to offer association health plans, and the second would allow employers to provide tax-free contributions through individual coverage health reimbursement arrangements (ICHRAs) to help employees pay for health coverage in the individual market. Democrats have argued that these policies can be used by employers to discriminate against certain classes of employees. The Congressional Budget Office (CBO) estimates that the bill would add $348 million to the federal deficit over the next decade. The bill is unlikely to be taken up by the Democratic- controlled Senate. The House and Senate will return to session the week of July 10th.

Senate Appropriators Adopt 302(b) Allocations, Two FY24 Spending Bills

Senate appropriators have adopted the top-line spending levels agreed to in this year’s bipartisan debt limit deal. The Senate Appropriations Committee agreed to the subcommittee allocations for fiscal year (FY) 2024’s twelve annual appropriations bills by a 15-13 party line vote. The figures represent a $12.2 billion cut compared to FY 2023 levels, but are consistent with the debt limit agreement signed into law earlier this month. Committee Chair Patty Murray (D-Wash.), however, has stated plans to redirect unspent funds and use emergency spending to increase total spending levels. Republicans objected to the topline figures, stating that they were not consulted in the drafting of the allocations. Their Republican counterparts in the House of Representatives have opted to adopt spending levels below the ceiling agreed to in the most recent debt limit negotiations.

Senate appropriators also advanced the Agriculture- Rural Development-Food and Drug Administration (FDA) and Military Construction-Veterans Affairs (VA) appropriations bills in two 28-0 votes last week. The Agriculture-FDA bill includes $26 billion in discretionary spending, a $513 million increase in budget authority over current levels. The FDA would see a $20 million increase. The Military Construction-VA bill includes $135.3 billion in nondefense discretionary spending, a slight increase over FY 2023. VA medical care would see a $2.3 billion increase for a total of $121 billion.

EPW Leadership Requests Comments on PFAS Discussion Draft

Leadership of the Senate Enviornment and Public Works (EPW) Committee has released a bipartisan draft bill on per- and polyfluoroalkyl substances (PFAS). The legislation seeks to improve the mitigation and remediation of PFAS contamination. The legal definition of PFAS included in the bill would exclude many types of the chemicals used by the medical device industry. The panel is requesting stakeholder comments on the draft by July 3, 2023.

RSC Releases FY2024 Budget, Includes Medicare Reforms

The Republican Study Committee (RSC) released its fiscal year 2024 budget last week. The proposal, titled “Protecting America’s Economic Security,” balances the budget in seven years, cuts spending by $16.3 trillion over the next decade, and reduces taxes by $5.1 trillion over 10 years. The budget is comprised of over 220 individual bills and initiatives from RSC members, including a Medicare premium support plan that would implement a model whereby the program’s trust funds would be merged into a single fund that would pay premium subsidies to Medicare beneficiaries. The RSC budget asserts that this type of model could reduce premiums overall by 7%.

Blunt Rochester Officially Enters DE Senate Race

As expected, Rep. Lisa Blunt Rochester (D-Del.) has filed the paperwork necessary to launch a 2024 Senate campaign. Sen. Tom Carper (D-Del.) announced earlier this year that he would not seek reelection and endorsed Blunt Rochester to succeed him. If elected, she would be the first woman and first person of color to serve the state of Delaware in the Senate.

Employers Endorse Legislation to Address “Dishonest Billing”

The ERISA Industry Committee has spearheaded a letter to members of Congress signed by other business stakeholders endorsing the Facilitating Accountability in Reimbursement (FAIR) Act (H.R. 3417), and the Site-based Invoicing and Transparency Enhancement (SITE) Act (S.1869). The letter argues that the bills will help address the problem of dishonest billing, or when hospitals “secretly reclassify a doctor’s office they own as a hospital setting in order to charge more money.” The employers argue that these practices contribute to consolidation and higher prices across the health care industry. The FAIR Act, introduced by Reps. Kevin Hern (R-Okla.) and Annie Kuster (D-N.H.), aims to harmonize billing practices by ensuring all off-campus outpatient departments have separate national provider identification (NPI) numbers. It would also direct the Centers for Medicare and Medicaid Services to prioritize auditing facilities recently converted to off campus hospital outpatient departments to ensure they are meeting remote location of a hospital facility requirements. The SITE Act, introduced by Sens. Mike Braun (R-Ind.) and Maggie Hassan (D-N.H.), would end the 2015 Bipartisan Budget Act’s site-neutral exceptions, and prevent off-campus emergency departments from charging higher rates than on-campus emergency departments when standalone emergency facilities are near a hospital campus. It would also require health systems to establish and bill using a unique NPI for every off-campus outpatient department.

Upcoming Congressional Hearings and Markups

House Small Business Subcommittee on Oversight, Investigations, and Regulations hearing “Burdensome Red Tape: Overregulation in Health Care and the Impact on Small Businesses;” 10:00 a.m.; July 19

Recently Introduced Health Legislation

H.R.4202 – To amend title 18, United States Code, to expand to all firearms the requirement that Federal firearms licensees report sales of 2 or more handguns to the same unlicensed person within 5 consecutive business days. Sponsor: Torres, Norma J. [Rep.-D-CA-35]; Committees: House – Judiciary

H.R.4201 – To amend title 18, United States Code, to require a gun lock to be provided to every firearm purchaser. Sponsor: Tlaib, Rashida [Rep.-D-MI-12]; Committees: House – Judiciary

H.R.4195 – To amend title XXVII of the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to allow parental choice in the selection of primary health insurance coverage or primary coverage under a group health plan for certain dependent children. Sponsor: Davids, Sharice [Rep.-D-KS-3]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

H.Res.522 – Recognizing the role of father engagement in improving overall health outcomes during pregnancy, birth, and postpartum, for both the mother and baby. Sponsor: Veasey, Marc A. [Rep.-D-TX-33]; Committees: House – Energy and Commerce

S.2044 – A bill to require the Secretary of Health and Human Services to establish reference prices for prescription drugs for purposes of Federal health programs, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

S.2052 – A bill to amend title XVIII of the Social Security Act to enforce any willing pharmacy requirements and establish safeguards to ensure patient access to pharmacies in Medicare part D, and for other purposes; Sponsor: Tester, Jon [Sen.-D- MT]; Committees: Senate – Finance

S.2059 – A bill to impose sanctions with respect to pharmaceutical companies of the People’s Republic of China and certain cartels that traffic fentanyl into the United States, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Banking, Housing, and Urban Affairs

H.R.4215 – To require the Secretary of Health and Human Services to establish reference prices for prescription drugs for purposes of Federal health programs, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce; Ways and Means; Armed Services; Veterans’ Affairs; Oversight and Accountability; Natural Resources

H.R.4223 – To establish an artificial intelligence commission, and for other purposes; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Science, Space, and Technology

S.Res.264 – A resolution designating June 2023 as “National Post-Traumatic Stress Awareness Month” and June 27, 2023, as “National Post-Traumatic Stress Awareness Day”; Sponsor: Sullivan, Dan [Sen.-R-AK]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.2070 – A bill to prohibit the Secretary of Veterans Affairs from replacing physician anesthesiologists with certified registered nurse anesthetists under the health care system of the Department of Veterans Affairs, and for other purposes; Sponsor: Cantwell, Maria [Sen.-D-WA]; Committees: Senate – Veterans’ Affairs

S.2078 – A bill to direct the Secretary of Veterans Affairs to take actions necessary to ensure that certain individuals may update the burn pit registry with the cause of death of a registered individual, and for other purposes; Sponsor: Welch, Peter [Sen.-D-VT]; Committees: Senate – Veterans’ Affairs

POLICY BRIEFINGS
Recently Introduced Health Legislation Contd.

S.2079 – A bill to amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug intended for human use to identify each ingredient in such drug that is, or is derived directly or indirectly from, a major food allergen or a gluten-containing grain, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

S.2080 – A bill to reauthorize and improve the pilot program to support State medical stockpiles, to ensure that State, local, Tribal, and territorial public health departments or officials are consulted by the Public Health Emergency Medical Countermeasures Enterprise, and for other purposes; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

S.2081 – A bill to amend section 485 of the Higher Education Act of 1965 to require venue-specific heat illness emergency action plans for any institution of higher education that is a member of an athletic association or athletic conference, and for other purposes; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Health, Education, Labor, and Pensions

S.2084 – A bill to direct the Secretary of Defense to establish an outreach program to inform members of the Armed Forces assigned to work near burn pits of the risks of toxic exposure, and for other purposes; Sponsor: Welch, Peter [Sen.- D-VT]; Committees: Senate – Armed Services

S.2085 – A bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests; Sponsor: Crapo, Mike [Sen.-R-ID]; Committees: Senate – Finance

S.2093 – A bill to establish a program at BARDA for developing medical countermeasures for viral threats with pandemic potential; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

S.2101 – A bill to provide for an earlier effective date for the requirement of Senate confirmation of the Director of the Centers for Disease Control and Prevention; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

H.Res.530 – Expressing support for the designation of June 21, 2023, as National ASK (Asking Saves Kids) Day to promote children’s health and safe storage of guns in the home; Sponsor: Crow, Jason [Rep.-D-CO-6]; Committees: House – Energy and Commerce

H.R.4240 – To require that opioid overdose rescue kits be located at public elementary and secondary schools, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Education and the Workforce; Energy and Commerce

H.R.4242 – To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue guidance on considerations for conducting clinical trials for psychedelic assisted therapy; Sponsor: Crenshaw, Dan [Rep.-R-TX-2]; Committees: House – Energy and Commerce

H.R.4249 – To amend title 38, United States Code, to furnish hospital care and medical services to veterans and dependents who were stationed at military installations at which the veterans and dependents were exposed to perfluorooctanoic acid or other per- and polyfluoroalkyl substances, to provide for a presumption of service connection for certain veterans who were stationed at military installations at which the veterans were exposed to such substances, and for other purposes; Sponsor: Kildee, Daniel T. [Rep.-D-MI-8]; Committees: House – Veterans’ Affairs

H.R.4256 – To amend section 485 of the Higher Education Act of 1965 to require venue-specific heat illness emergency action plans for any institution of higher education that is a member of an athletic association or athletic conference, and for other purposes; Sponsor: Mfume, Kweisi [Rep.-D-MD-7]; Committees: House – Education and the Workforce

H.R.4261 – To amend titles XVIII and XIX of the Social Security Act to provide for coverage of peripheral artery disease screening tests furnished to at-risk beneficiaries under the Medicare and Medicaid programs without the imposition of cost-sharing requirements, and for other purposes; Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Energy and Commerce; Ways and Means

H.R.4262 – To direct the Secretary of Veterans Affairs to provide for the online administration of the Civilian Health and Medical Program of the Department of Veterans Affairs, and for other purposes; Sponsor: Peters, Scott H. [Rep.-D-CA-50]; Committees: House – Veterans’ Affairs

H.R.4263 – To amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug intended for human use to identify each ingredient in such drug that is, or is derived directly or indirectly from, a major food allergen or a gluten- containing grain, and for other purposes; Sponsor: Phillips, Dean [Rep.-D-MN-3]; Committees: House – Energy and Commerce

H.R.4269 – To direct the Secretary of Labor to conduct a study on the effectiveness of spending by the Occupational Safety and Health Administration to provide technical assistance and compliance assistance in relation to heat-related illness; Sponsor: Tenney, Claudia [Rep.-R-NY-24]; Committees: House – Education and the Workforce

S.Res.270 – A resolution designating July 15, 2023, as “National Leiomyosarcoma Awareness Day”; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Judiciary

S.Res.271 – A resolution designating June 15, 2023, as “World Elder Abuse Awareness Day” and the month of June as “Elder Abuse Awareness Month”; Sponsor: Grassley, Chuck [Sen.-R-IA]; Committees: Senate – Judiciary

S.Res.276 – A resolution expressing opposition to the use of State power against people in the United States seeking essential health care, including criminalization of the full range of sexual and reproductive health care such as abortion, gender-affirming care, and contraceptive care, and disapproving of State punishment of people for their pregnancy outcomes; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

S.Res.283 – A resolution recognizing June 28, 2023, as the 125th anniversary of the American Association of Colleges of Osteopathic Medicine and commending the work of the association to improve the health of the people of the United States; Sponsor: Risch, James E. [Sen.-R-ID]; Committees: Senate – Health, Education, Labor, and Pensions

S.2107 – A bill to allow grantees under the HIV Health Care Services Program to allocate a portion of such funding for services to individuals at risk of acquiring HIV; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

S.2112 – A bill to make the Care Compare internet website and its data more accessible by individuals using search engines; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Finance

S.2115 – A bill to authorize the President to enter into trade agreements for the reciprocal elimination of duties or other import restrictions with respect to medical goods to contribute to the national security and public health of the United States, and for other purposes; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

S.2117 – A bill to allow participants in the National Health Service Corps to defer their obligated service in order to receive training in palliative care services; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

S.2118 – A bill to clarify the inability of the President to declare national emergencies under the National Emergencies Act, major disasters or emergencies under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, and public health emergencies under the Public Health Service Act on the premise of climate change, and for other purposes; Sponsor: Capito, Shelley Moore [Sen.-R-WV]; Committees: Senate – Environment and Public Works

S.2119 – A bill to reauthorize the Firefighter Cancer Registry Act of 2018; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

S.2128 – A bill to amend title XIX of the Social Security Act to increase Federal Medicaid funding for States that provide intensive community-based services for adults with serious mental illness, and for other purposes; Sponsor: Gillibrand, Kirsten E. [Sen.-D-NY]; Committees: Senate – Finance

S.2129 – A bill to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan and Medicare Advantage organizations offering an MA-PD plan under part D of the Medicare program that use a formulary to include certain drugs and biosimilar biological products on such formulary, and for other purposes; Sponsor: Lankford, James [Sen.-R-OK]; Committees: Senate – Finance

S.2131 – An original bill making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for the fiscal year ending September 30, 2024, and for other purposes; Sponsor: Heinrich, Martin [Sen.- D-NM]; Committees: Senate – Appropriations

S.2133 – A bill to amend title XVIII of the Social Security Act to establish a Medically Tailored Home-Delivered Meals Demonstration Program to test a payment and service delivery model under part A of Medicare to improve clinical health outcomes and reduce the rate of readmissions of certain individuals; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

S.2137 – A bill to amend title XVIII of the Social Security Act to ensure stability in payments to home health agencies under the Medicare program; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

S.2157 – A bill to repeal prescription drug price control provisions of the Inflation Reduction Act; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate – Finance

S.2163 – A bill to direct the Secretary of Education to study student mental health at institutions of higher education and to issue guidance on compliance with the Americans with Disabilities Act of 1990 for mental health and substance use disorder policies of institutions of higher education, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

S.2164 – A bill to increase oversight and transparency with respect to Medicare billing codes; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Finance

S.2172 – A bill to amend the Internal Revenue Code of 1986 to exclude from gross income certain federally-subsidized loan repayments for dental school faculty; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Finance

S.2183 – A bill to require the Secretary of Health and Human Services to establish an exposure registry and conduct epidemiological studies to assess health outcomes associated with the Red Hill Incident; Sponsor: Schatz, Brian [Sen.-D- HI]; Committees: Senate – Armed Services

S.2186 – A bill to require the Center for Medicare and Medicaid Innovation to test allowing blood transfusions to be paid separately from the Medicare hospice all-inclusive per diem payment; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Finance

S.2188 – A bill to increase access to pre-exposure prophylaxis to reduce the transmission of HIV; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

S.2191 – A bill to amend the Public Health Service Act to ensure the consensual donation and respectful disposition of human bodies and human body parts donated or transferred for education, research, or the advancement of medical, dental, or mortuary science and not for use in human transplantation, and for other purposes; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

S.2194 – A bill to remove limitations under Medicaid, Medicare, CHIP, and the Department of Veterans Affairs on benefits for persons in custody pending disposition of charges; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Finance

S.2198 – A bill to require the Comptroller General of the United States to conduct a study and submit a report on price- related compensation and payment structures in the prescription drug supply chain; Sponsor: Bennet, Michael F. [Sen.-D- CO]; Committees: Senate – Finance

S.2205 – A bill to regulate human cadaveric islets for transplantation as organs; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate – Health, Education, Labor, and Pensions

S.2213 – A bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivor’s background, or forthcoming survivorship needs, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Finance

H.R.4272 – To provide public awareness and outreach regarding the dangers of fentanyl, to expand the grants authorized under the Comprehensive Opioid Abuse Grant Program, to expand treatment and recovery services for people with opioid addictions, and to increase and to provide enhanced penalties for certain offenses involving counterfeit pills; Sponsor: Jackson Lee, Sheila [Rep.-D-TX-18]; Committees: House – Energy and Commerce; Judiciary

H.R.4274 – To require the Secretary of Health and Human Services to improve the detection, prevention, and treatment of mental health issues among public safety officers, and for other purposes; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce; Science, Space, and Technology

H.R.4275 – To amend the Public Health Service Act to ensure the consensual donation and respectful disposition of human bodies and human body parts donated or transferred for education, research, or the advancement of medical, dental, or mortuary science and not for use in human transplantation, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce

H.R.4279 – To establish the National Commission on Critical Supply Chains, and for other purposes; Sponsor: Brown, Shontel M. [Rep.-D-OH-11]; Committees: House – Energy and Commerce

H.R.4281 – To establish the Office of Sexual and Reproductive Health and Well-Being within the Department of Health and Human Services, to generate a whole-of-government approach to protecting and affirming sexual and reproductive rights, and for other purposes; Sponsor: Bush, Cori [Rep.-D-MO-1]; Committees: House – Energy and Commerce

H.R.4286 – To amend title XIX of the Social Security Act to require coverage under State plans under the Medicaid program for annual lung cancer screening with no cost sharing for individuals for whom screening is recommended by U.S. Preventive Services Task Force guidelines, to expand coverage under Medicaid of counseling and pharmacotherapy for cessation of tobacco use, and for other purposes; Sponsor: Higgins, Brian [Rep.-D-NY-26]; Committees: House – Energy and Commerce; Ways and Means

H.R.4300 – To clarify the inability of the President to declare national emergencies under the National Emergencies Act, major disasters or emergencies under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, and public health emergencies under the Public Health Service Act on the premise of climate change, and for other purposes; Sponsor: Pfluger, August [Rep.-R-TX-11]; Committees: House – Transportation and Infrastructure; Energy and Commerce

H.R.4304 – To regulate human cadaveric islets for transplantation as organs; Sponsor: Rosendale Sr., Matthew M. [Rep.-R- MT-2]; Committees: House – Energy and Commerce

H.R.4306 – To amend title 38, United States Code, to establish presumptions of service connection for diseases associated with firefighting; Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]; Committees: House – Veterans’ Affairs

H.R.4307 – To authorize the President to enter into trade agreements for the reciprocal elimination of duties or other import restrictions with respect to medical goods to contribute to the national security and public health of the United States, and for other purposes; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Ways and Means; Rules

After blocking floor votes on several bills in opposition to the spending caps set by the recent debt ceiling compromise negotiated by the White House and House Speaker Kevin McCarthy (R-Calif.), a small group of conservative Republicans in the House of Representatives appear to have won concessions from the Speaker to cut spending by an additional $120 billion. In defending his new agreement, McCarthy stated that the debt deal decided “a ceiling, not a floor” for spending, and that it was always his intention to pass appropriations legislation below the Fiscal Responsibility Act’s caps. The new plan would permit $1.47 trillion in discretionary spending for fiscal year (FY) 2024. The Departments of Labor, Education, and Health and Human Services would be cut by 29% under the GOP plan.

The House Appropriations Committee advanced its FY 2024 Agriculture-Rural Development-Food and Drug Administration (FDA) spending bill last week. The package, which was approved via a party-line vote, would trim 2.1% in overall spending compared to FY 2023. The bill provides $6.6 billion for the FDA, including user fee funding, less than the $7.2 billion requested by the agency in the President’s budget. It includes a provision to restrict access to the abortion medication mifepristone. The policy would nullify the FDA’s January decision to remove the in-person dispensing requirement for the drug. The legislation also includes a measure to prevent the agency from prohibiting the sale of menthol cigarettes and flavored cigars, or from limiting the amount of nicotine allowed in cigarettes. The Senate Appropriations Committee will begin consideration of the first of its FY 2024 spending bills this week, marking up the Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2024 and the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024 on Thursday.

 

Lawmakers Grapple with Ongoing Drug Shortages

Democrats on the House Energy and Commerce Committee are threatening to oppose a package to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) if provisions to address the nation’s ongoing drug shortages are not included. The reauthorization package was negotiated by Energy and Commerce Committee members Richard Hudson (R-N.C.) and Anna Eshoo (D-Calif.), but Eshoo recently stated that she has pulled her support for the bill after Republicans refused to include a measure to increase transparency in the drug supply chain. During a legislative hearing focused on the PAHPA reauthorization last week, panel Republicans argued that a narrow reauthorization would help ensure House passage of the legislation, but committed to separately work on a bipartisan basis to address the problem of drug shortages. PAHPA’s pandemic preparedness programs expire September 30.

Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) are seeking information from health care stakeholders about the emerging and persistent drug shortages currently facing the nation. The lawmakers pose a series of 14 questions to inform their examination of the drivers of medication shortages and potential policy solutions “to bolster patient access and shore up our critical drug supply chains.” Feedback should be submitted to [email protected] by July 7.

 

Sanders Releases Report on Drug Pricing, Public Investment in Medical Research

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) has released a report highlighting the costs of drugs and medical devices that received funding from the National Institutes of Health (NIH). Sanders calls on the NIH to reinstate the use of reasonable pricing clauses in the agency’s contracting requirements. These clauses would force companies to set reasonable prices when they license NIH inventions. The HELP Committee has yet to notice a date for the confirmation hearing of Monica Bertagnolli to serve as the next NIH Director. Sanders has said that he will oppose any administration health nominee who does not commit to lowering drug prices.

 

Preventive Services Mandate Restored as Legal Challenge Proceeds

The Department of Justice (DOJ) has reached an agreement with the plaintiffs challenging the Affordable Care Act’s (ACA) preventive care mandate to protect no-cost coverage of certain services while the legal case proceeds. In exchange, DOJ has pledged to not enforce the mandate for the parties challenging the law who claim that coverage of HIV prevention drugs and other preventive care services violates their religious beliefs. The employers and individuals challenging the law have asserted that because members of the U.S. Preventive Services Task Force (USPSTF) are not Senate confirmed nor overseen by Senate confirmed federal employees, their recommendations for what services must be covered by insurers at no cost to the beneficiary cannot be enforced. They have also argued that coverage of pre-exposure prophylaxis medication – PrEP – to prevent the transmission of HIV violates their religious rights. The 5th U.S. Circuit Court of Appeals signed the stipulated order partially halting the lower court’s March ruling which struck the ACA’s requirement. While a ruling in the case is expected in the coming months, an appeal to the U.S. Supreme Court is likely no matter what decision the 5th Circuit reaches.

 

MedPAC, MACPAC Release June Reports to Congress

The Medicare Payment Advisory Commission (MedPAC) is recommending that the Centers for Medicare and Medicaid Services (CMS) lower its payment rates for telehealth services. MedPAC’s annual June Report to the Congress recommends that the agency rescind fee increases initially instituted in response to the COVID-19 pandemic as early as 2024. The Commission argues that providing care via telehealth does not cost practices as much as in-person care. The report suggests that the increased use of telehealth throughout the COVID-19 public health emergency did not adversely impact the quality of care, and only slightly increased costs for the Medicare program. MedPAC recommends that CMS work with Congress to standardize telehealth payments so as not to disincentivize in-person care, and expresses support for the use of beneficiary cost-sharing to help avoid overuse of virtual services.

The latest MedPAC report also recommends that lawmakers implement changes to the Medicare Part B benefit to lower drug spending. The panel suggests capping the payment rate for Part B drugs made available via the accelerated approval pathway, and recommends that Medicare be given the authority to use reference pricing to establish a single average sales price-based payment rate for Part B drugs and biologics with similar health effects. The report details the Commission’s concerns that current Medicare wage indexes are not accurate and create inequities in the health care system, and recommends that Congress replace current wage indexes with a new system for hospitals and providers. The June 2023 report also includes a recommendation that Congress align payment rates for the same services provided across different ambulatory settings.

The Medicaid and CHIP Payment and Access Commission (MACPAC) also released its June 2023 report last week. MACPAC recommends automatic adjustments to disproportion

 

New Research Paper Details MA Overpayments

Anew white paper from the Leonard D. Schaeffer Center for Health Policy & Economics indicates that Medicare Advantage (MA) plans were overpaid by 14.4% in 2020 due to favorable patient selection. Researchers found that patients with lower-than-average expenditures than those with similar risk factors were significantly more likely to switch from traditional Medicare to the MA program. As a result, the risk-score-adjusted expenditures for these 16.9 million beneficiaries who switched coverage between 2006 and 2019 were substantially below average. The report asserts that basing MA payment benchmarks on fee-for-service (FFS) expenditures is “increasingly problematic” as FFS enrollment continues to decline. Researchers stress the need for reforming how MA payments are set, such as by decoupling MA payments from FFS benchmarks or instituting competitive bidding.

 

Upcoming Congressional Hearings and Markups

House Energy and Commerce Subcommittee on Health legislative hearing “Responding to America’s Overdose Crisis: An Examination of Legislation to Build Upon the SUPPORT Act;” 10:00 a.m.; June 21

 

House Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing “Competition and Transparency: the Pathway Forward for a Stronger Health Care Market;” 10:15 a.m.; June 21

 

House Veterans’ Affairs Subcommittee on Health hearing on H.R. 3520, Veterans Care Improvement Act; H.R. 1182, Veterans Serving Veterans Act; H.R. 1774, VA Emergency Transportation Act; H.R. 2683, VA Flood Preparedness Act; H.R. 2768, PFC Joseph P. Dwyer Peer Support Program Act; H.R. 2818, Autonomy for Disabled Veterans Act; H.R. 3581, Caregiver Outreach and Program Enhancement (COPE) Act; H.R. 1278, DRIVE Act; H.R. 1639, VA Zero Suicide Demonstration Project Act; and H.R. 1815, Expanding Veterans’ Options for Long Term Care Act; 10:30 a.m.; June 21

 

Senate Veterans’ Affairs Committee hearing “Examining the Effectiveness of the Office of Integrated Veteran Care;” 3:30 p.m.; June 21

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “MACRA Checkup: Assessing Implementation and Challenges that Remain for Patients and Doctors;” 10:30 a.m.; June 22

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

H.Res.485 – Expressing support for the designation of “Batten Disease Awareness Day” on June 9. Sponsor: Bean, Aaron [Rep.-R-FL-4]; Committees: House – Oversight and Accountability

 

H.Res.490 – Supporting the designation of the week of June 12 through June 18, 2023, as “National Men’s Health Week”. Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Oversight and Accountability

 

H.R.3946 – To amend the Public Health Service Act to reauthorize and extend the Fetal Alcohol Spectrum Disorders Prevention and Services program, and for other purposes. Sponsor: Bacon, Don [Rep.-R-NE-2]; Committees: House – Energy and Commerce

 

H.R.3948 -To expand access to health care for veterans in the Freely Associated States, and for other purposes. Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Veterans’ Affairs

 

H.R.3962 – To establish a Federal Advisory Council to Support Victims of Gun Violence. Sponsor: Evans, Dwight [Rep.- D-PA-3]; Committees: House – Judiciary

 

H.R.3988 – To provide for congressional approval of national emergency declarations. Sponsor: Roy, Chip [Rep.-R- TX-21]; Committees: House – Transportation and Infrastructure; Foreign Affairs; Rules

 

H.R.3993 – To provide a private right of action against the maker of any component of a ghost gun, and any person who facilitated a sale of the ghost gun, for injury or death resulting from the use of the ghost gun. Sponsor: Torres, Ritchie [Rep.-D-NY-15]; Committees: House – Judiciary

 

S.1922 – A bill to amend title XVIII of the Social Security Act to provide coverage for wigs as durable medical equipment under the Medicare program, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Finance

 

S.1925 – A bill to require the Secretary of Health and Human Services to improve the detection, prevention, and treatment of mental health issues among public safety officers, and for other purposes; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.496 – Expressing support for the designation of June 13 as “Posttraumatic Growth Day”; Sponsor: Bergman, Jack [Rep.-R-MI-1]; Committees: House – Energy and Commerce

 

H.Res.498 – Recognizing June 28, 2023, as the 125th anniversary of the American Association of Colleges of Osteopathic Medicine and commending its work to improve the health of the people of the United States; Sponsor: Graves, Sam [Rep.- R-MO-6]; Committees: House – Education and the Workforce; Energy and Commerce

 

H.R.4005 – To direct the Comptroller General of the United States to conduct a study on naloxone access; Sponsor: Kuster, Ann M. [Rep.-D-NH-2]; Committees: House – Energy and Commerce

 

H.R.4007 – To ensure references to opioid overdose reversal agents in grant programs of the Department of Health and Human Services are not limited to naloxone; Sponsor: Armstrong, Kelly [Rep.-R-ND-At Large]; Committees: House – Energy and Commerce

 

H.R.4009 – To establish emergency paid sick leave for individuals impacted by a public health emergency, and for other purposes; Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; Committees: House – Education and the Workforce; Oversight and Accountability; House Administration; Judiciary; Ways and Means

 

H.R.4011 – To amend title XXVII of the Public Health Service Act to improve patient access to oral medications, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce

 

H.R.4012 – To repeal the guidance titled “CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter”; Sponsor: Brecheen, Josh [Rep.-R-OK-2]; Committees: House – Energy and Commerce

 

H.R.4027 – To amend title XVIII of the Social Security Act to eliminate late enrollment penalties under part B of the Medicare program for individuals residing in Puerto Rico if such individuals enroll within 5 years of becoming entitled to benefits under part A of such program; Sponsor: González-Colón, Jenniffer [Resident Commissioner-R-PR-At Large]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4028 – To amend titles XVIII and XIX of the Social Security Act to make premium and cost-sharing subsidies available to low-income Medicare part D beneficiaries who reside in Puerto Rico or another territory of the United States; Sponsor: González-Colón, Jenniffer [Resident Commissioner-R-PR-At Large]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4034 – To amend title XVIII of the Social Security Act to provide coverage for wigs as durable medical equipment under the Medicare program, and for other purposes; Sponsor: McGovern, James P. [Rep.-D-MA-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4047 – To amend title 38, United States Code, to increase the amount paid by the Secretary of Veterans Affairs to veterans for improvements and structural alterations furnished as part of home health services; Sponsor: Sorensen, Eric [Rep.-D-IL-17]; Committees: House – Veterans’ Affairs

 

S.Res.249 – A resolution expressing support for the designation of July 2023 as “National Sarcoma Awareness Month”; Sponsor: Johnson, Ron [Sen.-R-WI]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.250 – A resolution designating June 6, 2023, as National Naloxone Awareness Day; Sponsor: Scott, Rick [Sen.-R-FL]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.1950 – A bill to extend the temporary order for fentanyl-related substances; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Judiciary

 

S.1951 – A bill to amend title 38, United States Code, to expand entitlement of veterans to care from the Department of Veterans Affairs and to guarantee health care benefits for veterans enrolled in the patient enrollment system of the Department, and for other purposes; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Veterans’ Affairs

 

S.1954 – A bill to improve the provision of health care furnished by the Department of Veterans Affairs for veterans diagnosed with diabetes and heart disease, and for other purposes; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Veterans’ Affairs

 

S.1961 – A bill to require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks, and for other purposes; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.4053 – To provide for the review of the scheduling under the Controlled Substances Act of buprenorphine-naloxone combination products, and for other purposes; Sponsor: Kuster, Ann M. [Rep.-D-NH-2]; Committees: House – Energy and Commerce; Judiciary

 

H.R.4054 – To amend the SUPPORT for Patients and Communities Act to reauthorize grants to improve trauma support services and mental health care for children and youth in educational settings; Sponsor: Budzinski, Nikki [Rep.-D-IL-13]; Committees: House – Education and the Workforce

 

H.R.4056 – To amend title XIX of the Social Security Act to ensure that medical assistance is available to children in foster care who are placed in a qualified residential treatment program under the Medicaid program; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce

 

H.R.4057 – To amend the SUPPORT for Patients and Communities Act to reauthorize surveillance and data collection by the Centers for Disease Control and Prevention for child, youth, and adult trauma; Sponsor: Blunt Rochester, Lisa [Rep.-D- DE-At Large]; Committees: House – Energy and Commerce

 

H.R.4061 – To require the Secretary of Health and Human Services to establish an exposure registry and conduct epidemiological studies to assess health outcomes associated with the Red Hill Incident; Sponsor: Case, Ed [Rep.-D-HI-1]; Committees: House – Energy and Commerce; Armed Services

 

H.R.4063 – To amend the SUPPORT for Patients and Communities Act to reauthorize a pilot program for public health laboratories to detect fentanyl and other synthetic opioids; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

 

H.R.4076 – To authorize funding for a bilateral cooperative program with Israel for the development of health technologies; Sponsor: Pappas, Chris [Rep.-D-NH-1]; Committees: House – Energy and Commerce

 

H.R.4079 – To amend the Public Health Service Act to reauthorize a loan repayment program for the substance use disorder treatment workforce; Sponsor: Rogers, Harold [Rep.-R-KY-5]; Committees: House – Energy and Commerce

 

H.R.4080 – To amend the SUPPORT for Patients and Communities Act to extend a task force to develop best practices for trauma-informed identification, referral, and support; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Education and the Workforce; Energy and Commerce; Judiciary

 

H.R.4087 – To prohibit the use of Federal funds to conduct or support certain gain-of-function research by a foreign adversary; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Energy and Commerce

 

S.1967 – A bill to amend title XVIII of the Social Security Act to establish requirements relating to the responsibility of pharmacy benefit managers under Medicare part D; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Finance

 

S.1976 – A bill to amend title XVIII of the Social Security Act to clarify congressional intent and preserve patient access to home infusion therapy under the Medicare program, and for other purposes; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

S.1991 – A bill to reauthorize certain programs under the SUPPORT for Patients and Communities Act, and for other purposes; Sponsor: McConnell, Mitch [Sen.-R-KY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1994 – A bill to amend title 38, United States Code, to require medical facilities of the Department of Veterans Affairs to share certain data with State cancer registries, and for other purposes; Sponsor: Kelly, Mark [Sen.-D-AZ]; Committees: Senate – Veterans’ Affairs

 

S.1995 – A bill to support public health infrastructure; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1999 – A bill to protect an individual’s ability to access contraceptives and to engage in contraception and to protect a health care provider’s ability to provide contraceptives, contraception, and information related to contraception; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.4088 – To amend the SUPPORT for Patients and Communities Act to reauthorize a program to support individuals in substance use disorder treatment and recovery to live independently and participate in the workforce, and for other purposes; Sponsor: Barr, Andy [Rep.-R-KY-6]; Committees: House – Education and the Workforce; Energy and Commerce

 

H.R.4089 – To amend the Public Health Service Act to reauthorize grants for first responder training; Sponsor: D’Esposito, Anthony [Rep.-R-NY-4]; Committees: House – Energy and Commerce

 

H.R.4091 – To amend the SUPPORT for Patients and Communities Act to expand required reports on T-MSIS substance use disorder data to include mental health condition data; Sponsor: Valadao, David G. [Rep.-R-CA-22]; Committees: House – Energy and Commerce

 

H.R.4092 – To amend the Public Health Service Act to reauthorize support for residential treatment programs for pregnant and postpartum women; Sponsor: Perez, Marie Gluesenkamp [Rep.-D-WA-3]; Committees: House – Energy and Commerce

 

H.R.4093 – To provide for a study on the effects of remote monitoring on individuals who are prescribed opioids; Sponsor: Balderson, Troy [Rep.-R-OH-12]; Committees: House – Energy and Commerce

 

H.R.4095 – To amend the Public Health Service Act to reauthorize grants to address the problems of persons who experience violence related stress; Sponsor: De La Cruz, Monica [Rep.-R-TX-15]; Committees: House – Energy and Commerce

 

H.R.4096 – To amend title XIX of the Social Security Act to expand the application of Medicaid State programs to monitor antipsychotic medications to all Medicaid beneficiaries; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.4097 – To amend the Public Health Service Act to reauthorize mental and behavioral health education and training grants; Sponsor: Sykes, Emilia Strong [Rep.-D-OH-13]; Committees: House – Energy and Commerce

 

H.R.4098 – To amend the Public Health Service Act to reauthorize grants for building communities of recovery; Sponsor: Pettersen, Brittany [Rep.-D-CO-7]; Committees: House – Energy and Commerce

 

H.R.4099 – To amend the Public Health Service Act to reauthorize a program of preventing overdoses of controlled substances; Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce

 

H.R.4100 – To amend the Public Health Service Act to reauthorize a monitoring and education program regarding infections associated with illicit drug use and other risk factors; Sponsor: Chavez-DeRemer, Lori [Rep.-R-OR-5]; Committees: House – Energy and Commerce

 

H.R.4101 – To amend the Public Health Service Act to reauthorize a National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support; Sponsor: James, John [Rep.-R-MI-10]; Committees: House – Energy and Commerce

 

H.R.4102 – To amend the SUPPORT for Patients and Communities Act to reauthorize the Recovery Housing Program; Sponsor: Barr, Andy [Rep.-R-KY-6]; Committees: House – Financial Services

 

H.R.4104 – To amend title XVIII of the Social Security Act to clarify congressional intent and preserve patient access to home infusion therapy under the Medicare program, and for other purposes; Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4105 – To amend the Controlled Substances Act to prohibit certain acts related to fentanyl, analogues of fentanyl, and counterfeit substances, and for other purposes; Sponsor: Buck, Ken [Rep.-R-CO-4]; Committees: House – Judiciary; Energy and Commerce

 

H.R.4106 – To amend the 21st Century Cures Act to expressly authorize the use of certain grants to implement substance use disorder and overdose prevention activities with respect to fentanyl and xylazine test strips; Sponsor: Crockett, Jasmine [Rep.-D-TX-30]; Committees: House – Energy and Commerce

 

H.R.4110 – To provide the Food and Drug Administration with authority to conduct microbial sampling on concentrated animal feeding operations as necessary to facilitate a foodborne illness outbreak investigation, determine the root cause of an outbreak of foodborne illness, or address other public health needs; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Energy and Commerce

 

H.R.4115 – To amend title XVIII of the Social Security Act to apply prescription drug inflation rebates to drugs furnished in the commercial market and to change the base year for rebate calculations; Sponsor: Gallego, Ruben [Rep.-D-AZ-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4121 – To protect an individual’s ability to access contraceptives and to engage in contraception and to protect a health care provider’s ability to provide contraceptives, contraception, and information related to contraception; Sponsor: Manning, Kathy E. [Rep.-D-NC-6]; Committees: House – Energy and Commerce

 

H.R.4122 – To award posthumously a Congressional Gold Medal to Henrietta Lacks, in recognition of her immortal cells which have made invaluable contributions to global health, scientific research, our quality of life, and patients’ rights; Sponsor: Mfume, Kweisi [Rep.-D-MD-7]; Committees: House – Financial Services; House Administration

 

Recently Introduced Health Legislation Contd.

H.R.4132 – To provide for the imposition of sanctions with respect to forced organ harvesting within the People’s Republic of China, and for other purposes; Sponsor: Perry, Scott [Rep.-R-PA-10]; Committees: House – Foreign Affairs; Judiciary

 

H.R.4134 – To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish a process to allow the holders of abbreviated new drug applications to make labeling changes to include new or updated safety-related information, and for other purposes; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Energy and Commerce

 

S.Res.255 – A resolution expressing support for the designation of June 19, 2023, as “World Sickle Cell Awareness Day” in order to increase public awareness across the United States and global community about sickle cell disease and the continued need for empirical research, early detection screenings, novel effective treatments leading to a cure, and preventative care programs with respect to complications from sickle cell anemia and conditions relating to sickle cell disease; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Foreign Relations

 

S.Res.257 – A resolution designating July 19, 2023, as “Glioblastoma Awareness Day”; Sponsor: Graham, Lindsey [Sen.-R- SC]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.2009 – A bill to amend the Older Americans Act of 1965 to authorize a national network of statewide senior legal hotlines, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2012 – A bill to amend title XVIII of the Social Security Act to provide for coverage of dental services under the Medicare program; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Finance

 

S.2016 – A bill to amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Sponsor: Schatz, Brian [Sen.-D-HI]; Committees: Senate – Finance

 

S.2024 – A bill to provide for the establishment of an education program to expand abortion care training and access; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.2026 – A bill to provide support for programs of the Department of Veterans Affairs relating to the coordination of maternity health care, and for other purposes; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Veterans’ Affairs

 

S.2039 – A bill to amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.514 – Expressing support for the designation of June 19, 2023, as “World Sickle Cell Awareness Day” in order to increase public alertness across the United States and global community about sickle cell disease, the continued need for empirical research, early detection screenings for sickle cell trait carriers, novel effective treatments leading to a cure, and preventative care programs with respect to complications from sickle cell anemia and conditions related to sickle cell disease; Sponsor: Davis, Danny K. [Rep.-D-IL-7]; Committees: House – Energy and Commerce

 

H.R.4146 – To amend title XVIII of the Social Security Act to provide for coverage of dental services under the Medicare program; Sponsor: Barragan, Nanette Diaz [Rep.-D-CA-44]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.4147 – To provide for the establishment of an education program to expand abortion care training and access; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce

 

H.R.4150 – To improve the provision of health care furnished by the Department of Veterans Affairs for veterans diagnosed with diabetes and heart disease, and for other purposes; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House – Veterans’ Affairs

 

H.R.4157 – To require the Secretary of Veterans Affairs to prepare an annual report on suicide prevention, and for other purposes; Sponsor: Connolly, Gerald E. [Rep.-D-VA-11]; Committees: House – Veterans’ Affairs

 

H.R.4182 – To improve men’s health initiatives, and for other purposes; Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Energy and Commerce

 

H.R.4189 – To amend title XVIII of the Social Security Act to expand access to telehealth services, and for other purposes; Sponsor: Thompson, Mike [Rep.-D-CA-4]; Committees: House – Energy and Commerce; Ways and Means

Congress passed legislation last week to suspend the debt ceiling until 2025. Passage of the Fiscal Responsibility Act (H.R. 3746) ends the most significant standoff over the nation’s borrowing limit since 2011. The debt ceiling deal was passed by the House of Representatives on Wednesday 314-117 with support from 149 Republicans, including eight hard right Freedom Caucus members, and 165 Democrats. The Senate approved the measure on Thursday in a 63-36 vote with support from 44 Democrats, 2 Independents, and only 17 Republicans. President Joe Biden signed the bill into law on June 3, two days before the government would have defaulted on its debt obligations in the absence of a borrowing cap extension. The Congressional Budget Office (CBO) estimates that the agreement will reduce the deficit by $1.5 trillion through fiscal year (FY) 2033, including a $1.3 trillion reduction in discretionary spending starting in FY 2024. The agreement includes a 1% sequester on discretionary spending which would be triggered should Congress fail to pass all FY 2024 appropriations bills. The cuts would not impact mandatory programs such as Medicare and Social Security. The compromise was the culmination of weeks of negotiations between the White House and the office of House Speaker Kevin McCarthy (R-Calif.). While it was passed with bipartisan support in both chambers of Congress, the bill was criticized by the flanks of each party for the concessions made by both Republican and Democratic leadership. The table beginning on page two summarizes the major spending and policy provisions contained in the deal.

Durbin Urges FDA to Address Cancer Drug Shortages

Senate Judiciary Committee Chair Dick Durbin (D-Ill.) sent a letter to the Food and Drug Administration (FDA) last week calling on the agency to address ongoing shortages of the critical cancer medications carboplatin and cisplatin. In the letter, Durbin describes the adverse impact of drug shortages on medical research and ongoing clinical trials and discusses the widespread problems with the nation’s drug and medical supply chain. In the short term, he recommends that FDA “use its authority to allow for the safe importation of these drugs from other countries, work with manufacturers to extend expiration dates-if safe and appropriate-on existing supplies of the drugs, regularly provide clear and timely updates to providers on expected timelines for additional supply, and ensure expedited inspections and reviews to assist in resolving this shortage.”

Utah Representative Chris Stewart Announces Resignation

Utah Representative Chris Stewart (R-Utah) has announced his resignation from Congress citing his wife’s current health concerns. Stewart has served the second district of Utah for a decade. Before being elected to Congress in 2012, he was the CEO of the Shipley Group, a consulting firm focusing on energy and the environment. Stewart sits on the House Permanent Select Committee on Intelligence and the Appropriations Committee. He is also a member of the Judiciary Committee’s Select Subcommittee on the Weaponization of the Federal Government. Stewart has said that he will step down as soon as there is an orderly transition process in place. His resignation will have a negligible impact on the chamber’s balance of power given Rep. David Cicilline’s (D-R.I.) departure on June 1st. Cicilline previously announced plans to leave Congress to lead the Rhode Island Foundation. Congressman Cicilline served the first district of Rhode Island for 12 years. Prior to being elected to Congress, he was the mayor of Providence for two terms. Cicilline was a member of the Judiciary Committee and the Foreign Affairs Committee.

Biden Expected to Appoint Mandy Cohen to Lead CDC

President Joe Biden is expected to tap former North Carolina health secretary Mandy Cohen to replace the outgoing Rochelle Walensky as the next director of the Centers for Disease Control and Prevention (CDC). Walensky plans to step down from her post at the end of this month. Cohen is an internal medicine physician who served as chief of staff and later chief operations officer at the Centers for Medicare and Medicaid Services during the Obama administration. As North Carolina Department of Health and Human Services Secretary from 2017 to 2021, Cohen led the state’s response to the COVID-19 pandemic. She currently works as an executive at Aledade, a private sector firm that works to support physician-led accountable care organizations and value-based care solutions. According to the Washington Post, the President will make a formal announcement of his pick later this month. The position of CDC director does not currently require Senate confirmation.

96% of Americans Have Some Level of COVID-19 Immunity

New data from the Centers for Disease Control and Prevention (CDC) indicates that 96% of Americans have some level of COVID-19 antibodies present in their bodies. The CDC analyzed data from blood samples of approximately 143,000 Americans ages 16 and older from July through September 2022 and found that 96% of them contained antibodies to SARS-CoV-2 from previous infection or vaccination. This figure includes 22.6% from infection alone and 26.1% from vaccination alone; 47.7% had hybrid immunity. Hybrid immunity prevalence was lowest among adults aged 65 years or older. In CDC’s last analysis between April and June 2021, only 68% of blood samples contained COVID-19 antibodies.

Upcoming Congressional Hearings and Markups

House Education and Workforce Committee markup to consider five bills, including H.R. 1147, Whole Milk for Healthy Kids Act of 2023, H.R. 2813, Self-Insurance Protection Act, H.R. 2868, Association Health Plans Act, and H.R. 824, Telehealth Benefit Expansion for Workers Act of 2023; 10:15 a.m.; June 6

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Looking Back Before Moving Forward: Assessing CDC’s Failures in Fulfilling its Mission;” 10:30 am.; June 7

Senate Judiciary Subcommittee on Intellectual Property hearing “Artificial Intelligence and Intellectual Property – Part I: Patents, Innovation, and Competition;” 3:00 p.m.; June 7

Senate Veterans’ Affairs Committee hearing “An Abiding Commitment to Those Who Served: Examining Veterans’ Access to Long Term Care;” 3:00 p.m.; June 7

Senate Finance Committee hearing “Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs;” 10:00 a.m.; June 8

Senate Health, Education, Labor, and Pensions Committee hearing “Why Are So Many American Youth in a Mental Health Crisis? Exploring Causes and Solutions” 10:00 a.m.; June 8

Senate Judiciary Committee Executive Session to consider S. 1080, Cooper Davis Act to amend the Controlled Substances Act to require electronic communication service providers and remote computing services to report to the Attorney General certain controlled substances violations; 10:00 a.m.; June 8

House Energy and Commerce Subcommittee on Health field hearing “Addressing the Opioid Crisis: Examining the SUPPORT Act Five Years Later;” 9:30 a.m.; June 9

POLICY BRIEFINGS
Recently Introduced Health Legislation

H.R.3742 – To direct the Comptroller General of the United States to evaluate the Federal Government’s collection and sharing of public health data to respond to public health emergencies. Sponsor: Peters, Scott H. [Rep.-D-CA-50]; Committees: House – Energy and Commerce

H.R.3741 – To amend title X of the Public Health Service Act to prohibit funds under such title from being used for any system through which counseling or referrals are provided to individuals regarding abortion services. Sponsor: Mann, Tracey [Rep.-R-KS-1]; Committees: House – Energy and Commerce

S.1755 – A bill to amend title 10, United States Code, to extend the period during which certain survivors of a member of the Selected Reserve of the Ready Reserve of a reserve component of the Armed Forces are eligible for health benefits under TRICARE Reserve Select; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Armed Services

H.R.3751 – To require the Secretary of Defense to submit a report on overdoses among members of the Armed Forces; Sponsor: Moulton, Seth [Rep.-D-MA-6]; Committees: House – Armed Services H.R.3752 – To provide for civil monetary penalties for violations of mental health parity requirements; Sponsor: Norcross, Donald [Rep.-D-NJ-1]; Committees: House – Education and the Workforce

S.Res.229 – A resolution designating May 2023 as “National Brain Tumor Awareness Month”; Sponsor: Daines, Steve [Sen.-R-MT]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.1766 – A bill to require the Secretary of Defense to submit a report on overdoses among members of the Armed Forces; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Armed Services

S.1767 – A bill to amend the Public Health Service Act to provide for emergency grants to safeguard essential health care workers, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

S.1769 – A bill to amend title XIX of the Social Security Act to establish a demonstration project testing Whole Child Health Models, and for other purposes; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

S.1773 – A bill to amend the Public Health Service Act to provide for a national outreach and education strategy and research to improve behavioral health among the Asian American, Native Hawaiian, and Pacific Islander population, while addressing stigma against behavioral health treatment among such population; Sponsor: Hirono, Mazie K. [Sen.-D-HI]; Committees: Senate – Health, Education, Labor, and Pensions

S.1774 – A bill to amend the Social Security Act to provide for an increased Federal medical assistance percentage for State expenditures on certain behavioral health services furnished under the Medicaid program, and for other purposes; Sponsor: Warnock, Raphael G. [Sen.-D-GA]; Committees: Senate – Finance

S.1784 – A bill to increase language access to behavioral health services at eligible health centers, and for other purposes; Sponsor: Heinrich, Martin [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

S.1785 – A bill to establish programs to address addiction and overdoses caused by illicit fentanyl and other opioids, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

H.Res.459 – Expressing support for the designation of June 2, 2023, as “National Gun Violence Awareness Day” and June 2023 as “National Gun Violence Awareness Month”; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Judiciary

H.Res.460 – Expressing the sense of the House of Representatives that the Congress should enact the Older Americans Bill of Rights to establish that older Americans should have the right to live with dignity and with independence; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Education and the Workforce; Energy and Commerce; Ways and Means

H.R.3759 – To direct the Secretary of Transportation to establish a grant program to facilitate the installation, on bridges, of evidence-based suicide deterrents, including suicide prevention nets and barriers, and for other purposes; Sponsor: Beyer, Donald S., Jr. [Rep.-D-VA-8]; Committees: House – Transportation and Infrastructure

H.R.3760 – To amend title VII of the Public Health Service Act to strengthen the mental health workforce, and for other purposes; Sponsor: Carter, Troy [Rep.-D-LA-2]; Committees: House – Energy and Commerce

H.R.3761 – To amend the Social Security Act to provide for an increased Federal medical assistance percentage for State expenditures on certain behavioral health services furnished under the Medicaid program, and for other purposes; Sponsor: Castor, Kathy [Rep.-D-FL-14]; Committees: House – Energy and Commerce; Education and the Workforce

H.R.3768 -To address maternity care shortages and promote optimal maternity outcomes by expanding educational opportunities for midwives, and for other purposes; Sponsor: Hinson, Ashley [Rep.-R-IA-2]; Committees: House – Energy and Commerce

H.R.3771 – To establish a multiagency Middle School Mental Health Task Force at the Department of Education and the Department of Health and Human Services; Sponsor: Kean, Thomas H. [Rep.-R-NJ-7]; Committees: House – Education and the Workforce; Energy and Commerce

S.Res.231 – A resolution expressing support for the designation of June 2, 2023, as “National Gun Violence Awareness Day” and June 2023 as “National Gun Violence Awareness Month”; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Judiciary

S.Res.232 – A resolution expressing support for the designation of May 17, 2023, as “DIPG Pediatric Brain Cancer Awareness Day” to raise awareness of, and encourage research on, diffuse intrinsic pontine glioma tumors and pediatric cancers in general; Sponsor: Rubio, Marco [Sen.-R-FL]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.Res.234 – A resolution designating May 2023 as “Older Americans Month”; Sponsor: Kelly, Mark [Sen.-D-AZ]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.Res.235 – A resolution supporting the designation of the week of May 7, 2023, as “Children’s Mental Health Awareness Week” and May 11, 2023, as “Children’s Mental Health Awareness Day”; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.1792 – A bill to amend title 38, United States Code, to modify the program of comprehensive assistance for family caregivers of veterans, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans’ Affairs

S.1797 – A bill to establish a demonstration program to allow States to test payment models for maternity care provided under Medicaid and the Children’s Health Insurance Program; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

S.1798 – A bill to establish a Countering Weapons of Mass Destruction Office and an Office of Health Security in the Department of Homeland Security, and for other purposes; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Homeland Security and Governmental Affairs

S.1800 – A bill to amend the Public Health Service Act to reauthorize and extend the Fetal Alcohol Spectrum Disorders Prevention and Services program, and for other purposes; Sponsor: Murkowski, Lisa [Sen.-R-AK]; Committees: Senate – Health, Education, Labor, and Pensions

S.1803 – A bill to amend title XVIII of the Social Security Act to revise payment for air ambulance services under the Medicare program; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Finance

H.R.3783 – To protect public health and human safety by prohibiting the farming of mink for their fur, to compensate farmers as they transition out of the industry, and for other purposes; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House – Agriculture; Budget

H.R.3791 – To amend the Public Health Service Act with respect to public health data accessibility, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce

President Joe Biden and House Speaker Kevin McCarthy (R-Calif.) have reached a deal to avert a U.S. default on its debt obligations and suspend the debt ceiling through January 2025. The agreement – dubbed the Fiscal Responsibility Act – caps non-defense spending, keeping it roughly flat in 2024 and increasing it by just 1% in 2025. It includes a penalty if Congress fails to pass fiscal year (FY) 2024 appropriations legislation, imposing a 1% across the board cut if the bills are not passed. The compromise also expands work requirements in the Supplemental Nutrition Assistance Program from up to age 49 under current law to age 54. The more stringent work requirements would sunset in 2030 without further action by Congress.

The deal was crafted by Office of Management and Budget Director Shalanda Young, White House senior adviser Steve Ricchetti, White House legislative affairs director Louisa Terrell, Rep. Garret Graves (R-La.), Rep. Patrick McHenry (R-N.C.), and the Speaker’s chief of staff Dan Meyer. The House of Representatives will return to session during a planned Memorial Day recess. The House Rules Committee will consider the bill on Tuesday afternoon and McCarthy is expected to bring the bill for a vote on the House floor on Wednesday. Both Republican and Democratic leadership have indicated that there is enough support to pass the deal. If the package is sent to the Senate on Wednesday, the chamber could then vote on the bill as early as Saturday morning (June 3), unless members agree to advance the measure via unanimous consent. The Treasury is projected to run out of cash reserves on June 5.

In related news, the House Appropriations Committee postponed the markup of four FY 2024 appropriations bills last week, citing the then ongoing debate on the debt limit. Chair Kay Granger (R-Texas) stated that she wished to give Speaker McCarthy “maximum flexibility” as he engaged in debt ceiling negotiations with the White House. The panel was scheduled to mark up the Agriculture-Rural Development-Food and Drug Administration spending package last Wednesday. The Senate Appropriations Committee previously announced plans to consider funding bills starting in June.

 

House Passes WH-Endorsed Fentanyl Bill

The House of Representatives passed the HALT Fentanyl Act (H.R. 467) last week. The bill would make permanent the temporary scheduling of fentanyl-related substances (FRS) as Schedule I substances, which are subject to heighted regulatory and law enforcement. The temporary scheduling of FRS is set to expire at the end of 2024. The bill would cover those substances with a high potential for abuse and no currently accepted medical use; medical-grade fentanyl would continue to be a Schedule II substance. Seventy-four Democrats joined Republicans in support of the measure, which was also endorsed by the White House. Other Democrats, however, including House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.), criticized the legislation and raised concerns about its potential to exacerbate inequities in the criminal justice system and the possible implications for FRS that are found that have medical applications.

 

E&C Advances Six Health Bills

The House Energy and Commerce Committee advanced nineteen bills last week, including legislation to overhaul the nation’s organ donation system and to reform pharmacy benefit manager (PBM) practices. The panel advanced the six following health bills out of committee:

• H.R. 1418, theAnimal Drug User Fee Amendments of 2023was favorably reported to the House by a bipartisan vote of 49-0.
• H.R. 2544, theSecuring the U.S. Organ Procurement and Transplantation Network Actwas favorably reported to the House by a bipartisan vote of 48-0.
• H.R. 2666, theMedicaid VBPs for Patients (MVP) Actwas reported favorably to the House by a bipartisan vote of 31- 19.
• H.R. 3284, theProviders and Payers COMPETE Actwas reported favorably to the House by a bipartisan vote of 49-0.
• H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program, was favorably reported to the House by a vote of 29-22.
• H.R. 3561, thePromoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023or the PATIENT Act of 2023 was favorably reported to the House by a bipartisan vote of 49-0. The bill was amended to includeH.R. 3285, theFairness for Patient Medications Act.

 

Select COVID-19 Subcommittee Probes NIH Funding to Chinese Lab

House Select Subcommittee on the Coronavirus Crisis Pandemic Chairman Brad Wenstrup (R-Ohio) has sent a letter to the National Institutes of Health (NIH) requesting information on its 2020 decision to cut funding for the Wuhan Institute of Virology (WIV). According to a letter obtained by the panel, the NIH informed the University of California, Irvine in May 2020 that it would be terminating the subgrant funding to the Chinese laboratory because its research posed “serious bio-safety concerns.” Wenstrup blames the agency for publicly obscuring its support for the work of the WIV, which some suspect is the origin of the COVID-19 pandemic, while privately acknowledging the safety concerns posed by the research.

 

CBO Releases Latest Health Coverage Projections

The Congressional Budget Office (CBO) released updated projections last week of health insurance coverage for people under age 65 over the next decade. The share of Americans under age 65 who are uninsured is currently at a historic low of 8.3%, which CBO attributes to temporary policies instituted in response to the COVID-19 pandemic, including continuous coverage provisions in state Medicaid programs and enhanced premium subsidies in theAffordable Care Act’sindividual marketplace. CBO’s analysis indicates that more than six million people will lose their health insurance coverage following the end of these COVID-era policies. While the nation’s uninsured rate will remain below pre-pandemic levels, it is expected to rise from 8.3% to 10.1% in 2033.

 

Longtime Delaware Senator Carper to Retire in 2024

Sen. Tom Carper (D-Del.), 76, announced last week that he will not run for reelection in 2024. Carper has served for over 20 years in the Senate. Prior to this time, he served as the governor of Delaware and as the state’s sole representative in the U.S. House for five terms. He currently sits on the Enviornment and Public Works, Finance, and Homeland Security and Governmental Affairs committees. He is the fourth Democratic senator – along with Dianne Feinstein (Calif.), Debbie Stabenow (Mich.), and Ben Cardin (Md.) – to announce his retirement from the chamber. Carper has endorsed Rep. Lisa Blunt Rochester (D-Del.) to succeed him. Blunt Rochester has indicated that she is interested in running for the seat but has not officially announced her candidacy.

 

CMS Releases Updated FAQ on PHE Unwinding

The Centers for Medicare and Medicaid Services (CMS) released an updated frequently asked questions document last week on the end of the COVID-19 public health emergency (PHE) indicating that the Medicare program will no longer cover telehealth services provided by hospital-based physical and occupational therapists and speech language pathologists beyond 2023. CMS states that it will exercise discretion through the end of this year to continue paying for outpatient therapy provided via telehealth billed from institutional providers. The agency did not specify for how long skilled nursing facilities and home health agencies could continue to bill for telehealth therapy services. The most recent omnibus spending bill delinked Medicare telehealth access from the PHE declaration, extending reimbursement for certain telehealth services through 2024.

 

Upcoming Congressional Hearings and Markups

House Rules Committee meeting to consider the Fiscal Responsibility Act of 2023; 3:00 p.m.; May 30

 

Senate Judiciary Committee Executive Session to consider S. 1080,Cooper Davis Actto amend the Controlled Substances Act to require electronic communication service providers and remote computing services to report to the Attorney General certain controlled substances violations, and S. 474,REPORT Act;10:00 a.m.; June 1

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

 

H.Res.434 – Declaring a mental health crisis among youth in the United States, and expressing the pressing need for historic investments in mental health care for students; Sponsor: Moulton, Seth [Rep.-D-MA-6]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.Res.436 – Expressing support for the designation of the week of May 22 through 26, 2023, as “Educator Mental Health Awareness Week”; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Education and the Workforce

 

H.R.3561 -To promote hospital and insurer price transparency, and for other purposes; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.3570 – To provide public awareness and outreach regarding the dangers of fentanyl, to expand the grants authorized under the Comprehensive Opioid Abuse Grant Program, to expand treatment and recovery services for people with opioid addictions, and to increase and to provide enhanced penalties for certain offenses involving counterfeit pills; Sponsor: Jackson Lee, Sheila [Rep.-D-TX-18]; Committees: House – Energy and Commerce; Judiciary

 

H.R.3577 – To require the Assistant Secretary for Preparedness and Response to establish an automated supply chain tracking application that provides near real-time insight into the amount of critical medical and health supplies available in the Strategic National Stockpile; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce

 

H.R.3581 – To amend title 38, United States Code, to modify the family caregiver program of the Department of Veterans Affairs to include services related to mental health and neurological disorders, and for other purposes; Sponsor: Kiggans, Jennifer A [Rep.-R-VA-2]; Committees: House – Veterans’ Affairs

 

H.R.3583 – To provide for the overall health and well-being of young people, including the promotion and attainment of lifelong sexual health and healthy relationships, and for other purposes; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Education and the Workforce; Energy and Commerce

 

H.R.3584 – To direct the Secretary of Veterans Affairs to conduct and support research on the efficacy and safety of medicinal cannabis, and for other purposes; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Veterans’ Affairs

 

H.R.3589 – To require group health plans and group or individual health insurance coverage to provide coverage for over-the-counter contraceptives; Sponsor: Pressley, Ayanna [Rep.-D-MA-7]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means

 

H.Con.Res.48 – Condemning the Chinese Communist Party for the Wuhan Lab “leak” causing the deadly COVID-19 pandemic; Sponsor: Santos, George [Rep.-R-NY-3]; Committees: House – Foreign Affairs

 

H.R.3613 – To amend title XXVIII of the Public Health Service Act to eliminate the sunset of authority to make certain appointments for National Disaster Medical System, and for other purposes; Sponsor: Schrier, Kim [Rep.-D-WA-8]; Committees: House – Energy and Commerce

 

H.R.3616 – To direct the Administrator of the Federal Aviation Administration to include medications and medical equipment for the emergency treatment of known or suspected opioid overdose in aircraft emergency medical kits, and for other purposes; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Transportation and Infrastructure

 

H.R.3617 – To amend title 10, United States Code, to expand the authority to provide a wig and treat traction alopecia under the TRICARE program, and for other purposes; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Armed Services

 

H.R.3619 – To amend the Federal Food, Drug, and Cosmetic Act to ban certain substances in cosmetic products, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

H.R.3620 – To amend the Public Health Service Act with respect to cosmetic safety, with an emphasis on communities of color and professional salon workers, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.3621 – To amend title VI of the Federal Food, Drug, and Cosmetic Act to provide for greater transparency with respect to fragrance and flavor ingredients in cosmetics, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D- IL-9]; Committees: House – Energy and Commerce

 

H.R.3622 – To amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the supply chain transparency needed for companies to make safe cosmetics, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

H.R.3623 – To amend title XVIII of the Social Security Act to establish a national graduate nurse education program; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3629 – To amend the Controlled Substances Act to list fentanyl-related substances as schedule I controlled substances, and for other purposes; Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Energy and Commerce; Judiciary

 

H.R.3631 – To amend the Public Health Service Act to extend the authorization of appropriations for grants for State strategic stockpiles; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.3633 – To amend the Public Health Service Act to provide for a public awareness campaign with respect to human papillomavirus, and for other purposes; Sponsor: Castor, Kathy [Rep.-D-FL-14]; Committees: House – Energy and Commerce

 

H.R.3635 – To amend title XVIII of the Social Security Act to ensure fairness in Medicare hospital payments by establishing a floor for the area wage index applied with respect to certain hospitals; Sponsor: Ferguson, A. Drew, IV [Rep.- R-GA-3]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3641 – To direct the Secretary of Veterans Affairs to rescind guidelines and ensure the removal of signs and guidance relating to the COVID-19 pandemic; Sponsor: Jackson, Ronny [Rep.-R-TX-13]; Committees: House – Veterans’ Affairs

 

H.R.3644 – To amend title 38, United States Code, to extend the authorization period for emergency treatment in non- Department of Veterans Affairs medical facilities under the Veterans Community Care Program; Sponsor: Latta, Robert E. [Rep.-R-OH-5]; Committees: House – Veterans’ Affairs

 

H.R.3645 – To amend the Public Health Service Act to establish emergency grants to safeguard essential health care workers, and for other purposes; Sponsor: Lee, Summer L. [Rep.-D-PA-12]; Committees: House – Energy and Commerce

 

H.R.3649 – To direct the Secretary of Veterans Affairs to establish a pilot program to furnish hyperbaric oxygen therapy to a veteran who has a traumatic brain injury or post-traumatic stress disorder; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Veterans’ Affairs

 

H.R.3659 – To amend the Public Health Service Act to provide for a demonstration program to facilitate the clinical adoption of pregnancy intention screening initiatives by health care and social service providers; Sponsor: Bonamici, Suzanne [Rep.-D-OR-1]; Committees: House – Energy and Commerce

 

H.R.3664 – To prohibit the availability of Federal funds to the World Health Organization pending the conduct of an investigation relating to the influence over such organization by Chinese Communist Party, and for other purposes; Sponsor: Santos, George [Rep.-R-NY-3]; Committees: House – Foreign Affairs

 

H.R.3668 – To amend title 10, United States Code, to improve the TRICARE program for certain members of the Retired Reserve of the reserve components; Sponsor: Johnson, Bill [Rep.-R-OH-6]; Committees: House – Armed Services

 

H.R.3669 – To amend the Elementary and Secondary Education Act of 1965 to improve mental health services for students, and for other purposes; Sponsor: Allen, Rick W. [Rep.-R-GA-12]; Committees: House – Education and the Workforce

 

H.R.3671 – To require the Secretary of Health and Human Services to improve the detection, prevention, and treatment of mental health issues among public safety officers, and for other purposes; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce; Science, Space, and Technology

 

H.R.3674 – To amend title XVIII of the Social Security Act to increase the nonfacility practice expense relative value units for specified services furnished under the Medicare program; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3677 – To direct the Comptroller General of the United States to conduct reviews of certain budget requests of the President for the medical care accounts of the Department of Veterans Affairs; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House – Veterans’ Affairs

 

H.R.3679 – To direct the Administrator of the Federal Aviation administration to develop an interagency task force to develop and implement a strategy to identify and advance research on communicable diseases in air travel, and for other purposes; Sponsor: Cherfilus-McCormick, Sheila [Rep.-D-FL-20]; Committees: House – Science, Space, and Technology

 

H.R.3680 – To amend the Public Health Service Act to provide for a national outreach and education strategy and research to improve the behavioral and mental health of the Asian American, Native Hawaiian, and Pacific Islander population, while addressing stigma within such population against behavioral and mental health treatment; Sponsor: Chu, Judy [Rep.-D-CA-28]; Committees: House – Energy and Commerce

 

H.R.3682 – To amend the Public Health Service Act to authorize certain grants (for youth suicide early intervention and prevention strategies) to be used for school personnel in elementary and secondary schools and students in secondary schools to receive student suicide awareness and prevention training, and for other purposes; Sponsor: Cleaver, Emanuel [Rep.-D-MO-5]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.3684 – To direct the Secretary of Defense to establish a grant program for using psychedelic substances to treat certain conditions, and for other purposes; Sponsor: Crenshaw, Dan [Rep.-R-TX-2]; Committees: House – Armed Services

 

H.R.3688 – To provide for the mandatory recall of drugs regulated by the Food and Drug Administration; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Energy and Commerce

 

H.R.3691 – To amend title XVIII of the Social Security Act to revise payment for air ambulance services under the Medicare program; Sponsor: Estes, Ron [Rep.-R-KS-4]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3701 – To amend title XIX of the Social Security Act to strengthen coverage under the Medicaid program for certain foster youth individuals; Sponsor: Kamlager-Dove, Sydney [Rep.-D-CA-37]; Committees: House – Energy and Commerce

 

H.R.3703 – To direct the Comptroller General of the United States to conduct and complete a review examining the efforts of the Secretary of Health and Human Services to ensure that the United States is prepared to rapidly produce certain medical countermeasures in the event of a public health emergency, and for other purposes; Sponsor: Latta, Robert E. [Rep.-R-OH-5]; Committees: House – Energy and Commerce

 

H.R.3706 – To expand and enhance existing adult day programs for younger people with neurological diseases or conditions (such as multiple sclerosis, Parkinson’s disease, traumatic brain injury, or other similar diseases or conditions) to support and improve access to respite services for family caregivers who are taking care of such people, and for other purposes; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Energy and Commerce

 

H.R.3707 – To amend the Internal Revenue Code of 1986 to provide a tax credit for expenses for household and elder care services necessary for gainful employment; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Ways and Means

 

H.R.3710 – To amend title 18, United States Code, to prohibit health professionals from providing false or misleading information with respect to assisted reproduction, and for other purposes; Sponsor: McClain, Lisa C. [Rep.-R-MI-9]; Committees: House – Judiciary

 

H.R.3713 – To amend the Public Health Service Act to revise and extend projects relating to children and to provide access to school-based comprehensive mental health programs; Sponsor: Napolitano, Grace F. [Rep.-D-CA-31]; Committees: House – Energy and Commerce

 

H.R.3718 – To require the Secretary of Veterans Affairs to take certain actions to improve the processing by the Department of Veterans Affairs of claims for disability compensation for post-traumatic stress disorder, and for other purposes; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Veterans’ Affairs

 

H.R.3722 – To require a pilot program on activities under the pre-separation transition process of members of the Armed Forces for a reduction in suicide among veterans, and for other purposes; Sponsor: Nunn, Zachary [Rep.-R-IA-3]; Committees: House – Armed Services; Veterans’ Affairs

 

H.R.3723 – To amend the Federal Food, Drug, and Cosmetic Act to expand the types of devices for which required labeling may be made available solely by electronic means; Sponsor: Obernolte, Jay [Rep.-R-CA-23]; Committees: House – Energy and Commerce

 

H.R.3725 – To amend title XVIII of the Social Security Act to provide benefits under the Medicare program for first responders at the age of 57; Sponsor: Panetta, Jimmy [Rep.-D-CA-19]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3726 – To direct the Secretary of Education to study student mental health at institutions of higher education and to issue guidance on compliance with the Americans with Disabilities Act of 1990 for mental health and substance use disorder policies of institutions of higher education, and for other purposes; Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House – Education and the Workforce

 

H.R.3730 – To amend title XVIII of the Social Security Act to modernize provisions relating to rural health clinics under Medicare; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3731 – To authorize the Secretary of Health and Human Services to award grants to reduce barriers to immigrants becoming nurses or allied health professionals in the United States, and for other purposes; Sponsor: Smith, Adam [Rep.- D-WA-9]; Committees: House – Energy and Commerce

 

H.R.3732 – To authorize the Secretary of Health and Human Services to award grants for career support for skilled internationally educated health professionals; Sponsor: Smith, Adam [Rep.-D-WA-9]; Committees: House – Energy and Commerce

 

H.R.3733 – To address barriers immigrants and refugees face to entering the health care workforce, and for other purposes; Sponsor: Smith, Adam [Rep.-D-WA-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3736 – To amend title XIX of the Social Security Act to extend the requirement for State Medicaid plans to provide coverage for medication-assisted treatment; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

H.R.3737 – To direct the Director of the Centers for Disease Control and Prevention to submit a report to Congress on the feasibility of reporting data relating to injuries in high school sports to improve the safety of student athletes; Sponsor: Veasey, Marc A. [Rep.-D-TX-33]; Committees: House – Energy and Commerce; Education and the Workforce

The House Appropriations Subcommittee on Agriculture, Rural Development, and the Food and Drug Administration (FDA) advanced its fiscal year 2024 spending bill by voice vote last week. The bill would provide $6.6 billion in funding for the FDA, less than the $7.2 billion requested in the President’s budget. It includes provisions to block the FDA from allowing mail-order access to mifepristone and from banning menthol or setting a maximum nicotine level in cigarettes. The measure was criticized by panel Democrats who indicated plans to offer numerous amendments during the full committee markup, which is scheduled for May 24.

 

E&C Health Subcommittee Advances 17 Health Bills

The House Energy and Commerce Subcommittee on Health advanced 17billslast week, including legislation to overhaul the nation’s organ donation system, mandate additional reporting in the 340B program, reform pharmacy benefit manager (PBM) practices, and permit value-based purchasing agreements in state Medicaid programs. The panel advanced the following bills to the full committee:

• • H.R. 3281, theTransparent PRICE Actwhich was amended to include the following bills:
    • H.R. 3237, to require each outpatient department of a provider to include a unique identification number on claims for services, and to require hospitals with an outpatient department of a provider to submit to the Centers for Medicare & Medicaid Services an attestation with respect to each outpatient department
    • H.R. 3262, to amend title XI of the Social Security Act to increase transparency of certain health-related ownership information
    • H.R. 3248, theDiagnostic Lab Testing Transparency Act
    • H.R. 3282, thePromoting Transparency and Healthy Competition in Medicare Act
    • H.R. 2679, thePBM Accountability Act
    • H.R. 2559, theStrengthening Community Care Act of 2023
    • H.R. 2550, theSpecial Diabetes Program Reauthorization Act of 2023
    • H.R. 2547, theSpecial Diabetes Program for Indians Reauthorization Act of 2023
    • H.R. 2665, theSupporting Safety Net Hospitals Act
    • H.R. 1613, theDrug Price Transparency in Medicaid Act of 2023
  • H.R. 1418, theAnimal Drug User Fee Amendments of 2023
  • H.R. 2544, theSecuring the U.S. Organ Procurement and Transplantation Network Act
  • H.R. 2666, theMedicaid VBPs for Patients (MVP) Act
  • H.R. 3285, theFairness for Patient Medications Act
  • H.R. 3284, theProviders and Payers COMPETE Act
  • H.R. 3290, to amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug

discount program

 

Sanders Drafting $200 Billion Health Package

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) plans to propose a nearly $200 billion health care package that includes $130 billion in funding for community health centers and $60 billion to strengthen the health care workforce. While the HELP Committee has been working on a bipartisan basis on several health care related issues, Ranking Member Bill Cassidy (R-La.) indicated that the total amount of funding included in the Chairman’s plan may be too steep to garner Republican support. Funding for community health centers will expire on September 30th if the program is not reauthorized before the end of the fiscal year. In the House of Representatives, leadership has reached an agreement to increase money for community health centers by approximately 5% over two years – a small fraction of the amount that has been proposed by Sanders.

 

Lawmakers Press MA Insurers on Claims Denials

Republicans on the House Energy and Commerce Committee have sent aletterto the CEO of The Cigna Group requesting an explanation of how the insurance company uses an automated system to deny medical claims without reading them. The request is in response to an investigative report by ProPublica focusing on Cigna’s procedure-to- diagnosis (PXDX) review process. The lawmakers highlight that 80% of Medicare Advantage (MA) coverage denials were overturned, suggesting that Cigna’s PXDX review process is leading to patients paying out-of-pocket for medical care that should be covered under their insurance policy contract. Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-Va.) ask Cigna to provide documents related to the PXDX process.

The Senate Homeland Security and Governmental Affairs Committee (HSGAC) is conducting its own investigation into the frequency of MA claims denials and the role that artificial intelligence (AI) plays in coverage determinations. The panel sent letters to the three largest MA insurers – Humana, United Healthcare, and CVS – asking for data on their number of prior authorization requests and denials since 2019. The lawmakers also ask for information about the use of software algorithms to deny prior authorization requests. HSGAC’s Permanent Subcommittee on Investigations also convened a hearing last week to consider the subject of health care denials and delays in the MA program.

 

NIH Nominee to Face Questions on Drug Pricing, EcoHealth Grants

President Joe Biden announced the nomination of National Cancer Institute Director Monica Bertagnolli to lead the National Institutes of Health (NIH). Bertagnolli’s nomination is subject to Senate confirmation. While there is not yet a timeline for consideration of her nomination, Senate HELP Committee Chairman Bernie Sanders (I-Vt.)wrotePresident Biden last month to say that he “will strongly oppose any future nominee to a major federal health agency who is not prepared to significantly lower the price of prescription drugs in this country.” Republicans, including Ranking Member Bill Cassidy (R-La.), are expected to discuss with Bertagnolli the origins of the coronavirus pandemic and NIH grants to EcoHealth Alliance.

 

Scott Files Paperwork to Run for President

Sen. Tim Scott (R-S.C.) has filed paperwork with the Federal Election Commission to enter the 2024 presidential race. He is expected to formally launch his campaign on Monday. The GOP field currently includes former President Donald Trump, former U.S. ambassador to the United Nations Nikki Haley, entrepreneur Vivek Ramaswamy, former Arkansas Governor Asa Hutchinson, and conservative radio host Larry Elder. Scott has served in the Senate since 2013 and is currently a member of the Finance Committee, Health, Education, Labor, and Pensions Committee, and Special Committee on Aging. Florida Governor Ron DeSantis is expected to announce his plan to run for president mid-week.

 

GAO Releases New Report on Noncompete Agreements

The Government Accountability Office (GAO) has released a newreportdetailing its investigation into non-compete agreements, including those in the health care and social assistance employment sector. The GAO found that 57% of health care and social assistance employers surveyed require new hires to sign agreements restricting them from taking jobs with rival companies. The report was requested by Sens. Ron Wyden (D-Ore.), Elizabeth Warren (D-Mass.), Tim Kaine (D-Va.), Christopher Murphy (D-Conn.), Marco Rubio (R-Fla.), and Todd Young (R-Ind.).

 

ARPA-H Announces Inaugural Program

The Advanced Research Projects Agency for Health (ARPA-H) announced the launch of its first program last week. The Novel Innovations for Tissue Regeneration in Osteoarthritis (NITRO) aims to develop breakthroughs that would allow the human body to repair its owns joints. Osteoarthritis is a leading cause of disability in the U.S. It impacts more than 32 million Americans and costs an estimated $136 billion per year. Research teams interested in in NITRO can find more information about a Proposers’ Dayhere.

 

Upcoming Congressional Hearings and Markups

House Oversight and Accountability Committee hearing “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part I: Self-Interest or Health Care?” 10:00 a.m.; May 23

 

House Veterans’ Affairs Committee hearing “COVID-19 Supplemental Funding: Did It Protect and Improve Veteran Care?” 10:00 a.m.; May 23

 

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “VA Information Technology Contracting: Challenges in Consolidation of Competition and Conflict of Interest;” 8:00 a.m.; May 24

 

House Oversight and Accountability Subcommittee on Economic Growth, Energy Policy, and Regulatory Affairs hearing “Consumer Choice on the Backburner: Examining the Biden Administration’s Regulatory Assault on Americans’ Gas Stoves;” 10:00 a.m.; May 24

 

House Appropriations Committee markup of fiscal year 2024 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill; 10:00 a.m.; May 24

 

House Ways and Means Subcommittee on Trade hearing “Modernizing Customs Policies to Protect American Workers and Secure Supply Chains;” 9:00 a.m.; May 25

 

House Oversight and Accountability Subcommittee on Cybersecurity, Information Technology, and Government Innovation field hearing “Advances in AI: Views from Silicon Valley;” 10:00 a.m.; June 1

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

S.1592 – A bill to clarify coverage of occupational therapy under the Medicare program; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Finance

 

S.1594 – A bill to require the Secretary of Health and Human Services to convene a task force to develop strategies and coordinate efforts to eliminate preventable maternal mortality, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1595 – A bill to prohibit taxpayer-funded gender transition procedures, and for other purposes; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Finance

 

S.1597 – A bill to amend chapter 110 of title 18, United States Code, to prohibit gender transition procedures on minors, and for other purposes; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Judiciary

 

S.1598 – A bill to clarify and improve accountability for certain members of the Armed Forces during consideration for medical separation in the Integrated Disability Evaluation System of the Department of Defense, and for other purposes; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Armed Services

 

S.1599 – A bill to amend the Public Health Service Act to provide for grants to promote representative community engagement in maternal mortality review committees, and for other purposes; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1601 – A bill to protect moms and babies against climate change, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1602 – A bill to provide for grants to address maternal mental health conditions and substance use disorders, and for other purposes; Sponsor: Gillibrand, Kirsten E. [Sen.-D-NY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1603 – A bill to amend the Public Health Service Act to increase vaccination rates of pregnant and postpartum individuals, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1605 – A bill to authorize appropriations for data collection, surveillance, and research on maternal health outcomes during public health emergencies, and for other purposes; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1606 – A bill to end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.404 – Expressing support for the designation of May 15, 2023, as “Prader-Willi Syndrome Awareness Day” to raise awareness of and promote research on the disorder; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

H.R.3281 – To promote hospital and insurer price transparency; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce

 

H.R.3282 – To amend title XVIII of the Social Security Act to promote transparency of common ownership interests under parts C and D of the Medicare program; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3284 – To require the Secretary of Health and Human Services to submit an annual report on the impact of certain Medicare regulations on provider and payer consolidation; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3285 – To establish patient protections with respect to highly rebated drugs; Sponsor: Griffith, H. Morgan [Rep.-R- VA-9]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means

 

H.R.3290 – To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Energy and Commerce

 

H.R.3302 – To protect Moms and babies against climate change, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce

 

H.R.3303 – To provide support for programs of the Department of Veterans Affairs relating to the coordination of maternity health care, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Veterans’ Affairs

 

H.R.3304 -To authorize appropriations for data collection, surveillance, and research on maternal health outcomes during public health emergencies, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce

 

H.R.3305 – To end preventable maternal mortality, severe maternal morbidity, and maternal health disparities in the United States, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce; Education and the Workforce; Veterans’ Affairs; Natural Resources; Judiciary

 

H.R.3310 – To end preventable maternal mortality and severe maternal morbidity in the United States and close disparities in maternal health outcomes, and for other purposes; Sponsor: Adams, Alma S. [Rep.-D-NC-12]; Committees: House – Energy and Commerce

 

H.R.3312 – To address maternal mental health conditions and substance use disorders, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.3320 – To amend the Public Health Service Act to improve maternal health data collection processes and quality measures, and for other purposes; Sponsor: Davids, Sharice [Rep.-D-KS-3]; Committees: House – Energy and Commerce; Natural Resources

 

H.R.3322 – To address social determinants of maternal health to eliminate maternal mortality, severe maternal morbidity, and maternal health disparities, and for other purposes; Sponsor: Hayes, Jahana [Rep.-D-CT-5]; Committees: House – Energy and Commerce

 

H.R.3328 – To amend chapter 110 of title 18, United States Code, to prohibit gender transition procedures on minors, and for other purposes; Sponsor: LaMalfa, Doug [Rep.-R-CA-1]; Committees: House – Judiciary

 

H.R.3329 – To prohibit taxpayer-funded gender transition procedures, and for other purposes; Sponsor: LaMalfa, Doug [Rep.-R-CA-1]; Committees: House – Energy and Commerce; Judiciary; Ways and Means

 

H.R.3346 – To direct the Administrator of the Centers for Medicare & Medicaid Services to implement the Perinatal Care Alternative Payment Model Demonstration Project to test various payment models with respect to maternity care provided to pregnant and postpartum individuals, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

H.R.3347 – To prohibit the Secretary of Veterans Affairs from replacing physician anesthesiologists with certified registered nurse anesthetists under the health care system of the Department of Veterans Affairs, and for other purposes; Sponsor: Scott, David [Rep.-D-GA-13]; Committees: House – Veterans’ Affairs

 

H.R.3348 – To amend the Public Health Service Act with respect to maternal vaccination awareness and equity, and for other purposes; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Energy and Commerce

 

H.R.3352 – To amend the Internal Revenue Code of 1986 to treat diapers as qualified medical expenses; and to prohibit States and local governments to impose a tax on the retail sale of diapers; Sponsor: Watson Coleman, Bonnie [Rep.-D- NJ-12]; Committees: House – Ways and Means; Judiciary

 

S.1607 – A bill to amend title XVIII of the Social Security Act to permit a private cause of action for damages in the case of a group health plan which fails to provide for primary payment or appropriate reimbursement; Sponsor: Scott, Tim [Sen.-R-SC]; Committees: Senate – Finance

 

S.1610 – A bill to authorize administrative absences and travel and transportation allowances for members of the Armed Forces to travel and obtain reproductive health care; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Armed Services

 

S.1612 – A bill to require the Secretary of Veterans Affairs to publish a rule to implement the requirement that the Secretary be permitted to waive the limitation in law on reimbursement of veterans receiving domiciliary care in State homes; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Veterans’ Affairs

 

S.1621 – A bill to provide for an exemption from authorized strength limitations for licensed behavioral health providers; Sponsor: Ossoff, Jon [Sen.-D-GA]; Committees: Senate – Armed Services

 

S.1624 – A bill to require certain civil penalties to be transferred to a fund through which amounts are made available for the Gabriella Miller Kids First Pediatric Research Program at the National Institutes of Health, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1627 – A bill to amend the Internal Revenue Code of 1986 to create a tax credit for nurse preceptors; Sponsor: Kelly, Mark [Sen.-D-AZ]; Committees: Senate – Finance

 

H.R.3355 – To amend the Public Health Service Act to reauthorize a loan repayment program for the substance use disorder treatment workforce, and for other purposes; Sponsor: Rogers, Harold [Rep.-R-KY-5]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3368 – To require the Secretary of Veterans Affairs to publish a rule to implement the requirement that the Secretary be permitted to waive the limitation in law on reimbursement of veterans receiving domiciliary care in State homes; Sponsor: Golden, Jared F. [Rep.-D-ME-2]; Committees: House – Veterans’ Affairs

 

H.R.3373 – To direct the Secretary of the Navy to take certain actions relating to improved mental health care, and for other purposes; Sponsor: Kiggans, Jennifer A [Rep.-R-VA-2]; Committees: House – Armed Services

 

H.R.3379 – To amend title XVIII of the Social Security Act to improve access to skilled nursing facilities for primary immunodeficiency patients; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3380 – To amend the Public Health Service Act to expand and improve health care services by health centers and the National Health Service Corps for individuals with a developmental disability, and for other purposes; Sponsor: Moulton, Seth [Rep.-D-MA-6]; Committees: House – Energy and Commerce

 

H.R.3382 – To amend title XVIII of the Social Security Act to eliminate the coinsurance requirement for certain colorectal cancer screening tests furnished under the Medicare program; Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3387 – To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to provide for certain health coverage of newborns; Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means

 

H.R.3388 – To amend title XVIII of the Social Security Act to permit a private cause of action for damages in the case of a group health plan which fails to provide for primary payment or appropriate reimbursement; Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3391 – To extend the Gabriella Miller Kids First Pediatric Research Program at the National Institutes of Health, and for other purposes; Sponsor: Wexton, Jennifer [Rep.-D-VA-10]; Committees: House – Energy and Commerce

 

S.1633 – A bill to amend title 38, United States Code, to recognize and honor the service of individuals who served in the United States Cadet Nurse Corps during World War II, and for other purposes; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Veterans’ Affairs

 

S.1636 – A bill to amend title XVIII of the Social Security Act to protect access to telehealth services under the Medicare program; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Finance

 

S.1653 – A bill to amend the Public Health Safety Act to establish a program to award grants to State, local, and Tribal governments to purchase and distribute anti-blood loss supplies for use in a medical emergency, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1655 – A bill to establish a Medicare-for-all national health insurance program; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Finance

 

S.1656 – A bill to protect the privacy of personal reproductive or sexual health information, and for other purposes; Sponsor: Hirono, Mazie K. [Sen.-D-HI]; Committees: Senate – Commerce, Science, and Transportation

 

S.1664 – A bill to allow Americans to earn paid sick time so that they can address their own health needs and the health needs of their families; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1668 – A bill to improve the Organ Procurement and Transplantation Network, and for other purposes; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.415 – Expressing support for the designation of May as “National Bladder Cancer Awareness Month”; Sponsor: Cartwright, Matt [Rep.-D-PA-8]; Committees: House – Energy and Commerce

 

H.Res.416 – Expressing support for the designation of the 17th day in May as “DIPG Awareness Day” to raise awareness and encourage research into cures for diffuse intrinsic pontine glioma (DIPG) and pediatric cancers in general; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

 

H.Res.419 – Expressing support for the designation of May as Ehlers-Danlos Syndrome Awareness Month to increase the knowledge of this little-known, potentially fatal, genetic disease; Sponsor: Ruppersberger, C. A. Dutch [Rep.-D-MD-2]; Committees: House – Energy and Commerce

 

H.R.3409 – To allow Americans to earn paid sick time so that they can address their own health needs and the health needs of their families; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Education and the Workforce; House Administration; Oversight and Accountability

 

H.R.3412 – To authorize the Assistant Secretary for Mental Health and Substance Use, acting through the Director of the Center for Substance Abuse Treatment, to award grants to States to expand access to clinically appropriate services for opioid abuse, dependence, or addiction; Sponsor: Foster, Bill [Rep.-D-IL-11]; Committees: House – Energy and Commerce

 

H.R.3417 – To ensure fair billing practices for items and services furnished by off-campus outpatient departments of a provider; Sponsor: Hern, Kevin [Rep.-R-OK-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3420 – To protect the privacy of personal reproductive or sexual health information, and for other purposes; Sponsor: Jacobs, Sara [Rep.-D-CA-51]; Committees: House – Energy and Commerce

 

H.R.3421 – To establish an improved Medicare for All national health insurance program; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce; Rules; Oversight and Accountability; Armed Services; Judiciary

 

H.R.3426 – To amend the Internal Revenue Code of 1986 to include expenses relating to membership in health care sharing ministries to qualify for the deduction for medical expenses, and for other purposes; Sponsor: Kelly, Mike [Rep.-R- PA-16]; Committees: House – Ways and Means

 

H.R.3428 – To amend title 38, United States Code, to recognize and honor the service of individuals who served in the United States Cadet Nurse Corps during World War II, and for other purposes; Sponsor: Lawler, Michael [Rep.-R-NY-17]; Committees: House – Veterans’ Affairs; Armed Services

 

H.R.3432 – To amend title XVIII of the Social Security Act to ensure coverage of mental and behavioral health services furnished through telehealth; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3433 – To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes; Sponsor: McCaul, Michael T. [Rep.-R-TX-10]; Committees: House – Energy and Commerce

 

H.R.3440 – To amend title XVIII of the Social Security Act to protect access to telehealth services under the Medicare program; Sponsor: Pappas, Chris [Rep.-D-NH-1]; Committees: House – Energy and Commerce; Ways and Means

 

S.Res.221 – A resolution promoting minority health awareness and supporting the goals and ideals of National Minority Health Month in April 2023, which include bringing attention to the health disparities faced by minority populations of the United States such as American Indians, Alaska Natives, Asian Americans, African Americans, Hispanics, and Native Hawaiians or other Pacific Islanders; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Voice Vote.

 

S.Res.224 – A resolution designating May 2023 as “ALS Awareness Month”; Sponsor: Whitehouse, Sheldon [Sen.-D-RI]; Committees: Senate – Judiciary

 

S.1673 – A bill to amend title XVIII to protect patient access to ground ambulance services under the Medicare program; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Finance

 

S.1687 – A bill to amend title XVIII of the Social Security Act to establish a system to notify individuals approaching Medicare eligibility; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.1691 – A bill to amend title XVIII of the Social Security Act to improve the enrollment of retiring individuals in the Medicare program; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.1697 – A bill to provide for the overall health and well-being of young people, including the promotion and attainment of lifelong sexual health and healthy relationships, and for other purposes; Sponsor: Hirono, Mazie K. [Sen.-D-HI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1698 – A bill to require group health plans and group or individual health insurance coverage to provide coverage for over-the-counter contraceptives; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1699 – A bill to support the use of technology in maternal health care, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1700 – A bill to address mental health issues for youth, particularly youth of color, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1701 – A bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1703 – A bill to amend title XVIII of the Social Security Act to ensure Medicare-only PACE program enrollees have a choice of prescription drug plans under Medicare part D; Sponsor: Carper, Thomas R. [Sen.-D-DE]; Committees: Senate – Finance

 

 

S.1710 – A bill to amend the Public Health Service Act to grow and diversify the perinatal workforce, and for other purposes; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1712 – A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1729 – A bill to facilitate nationwide accessibility and coordination of 211 services and 988 services in order to provide information and referral to all residents and visitors in the United States for mental health emergencies, homelessness needs, other social and human services needs, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1745 – A bill to amend title 38, United States Code, to expand access to the Veterans Community Care Program of the Department of Veterans Affairs to include certain veterans seeking mental health or substance-use services, and for other purposes; Sponsor: Daines, Steve [Sen.-R-MT]; Committees: Senate – Veterans’ Affairs

 

S.1749 – A bill to amend title XVIII and XIX of the Social Security Act with respect to nursing facility requirements, and for other purposes; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

H.Res.425 – Supporting the designation of July 19, 2023, as “Glioblastoma Awareness Day”; Sponsor: Mast, Brian J. [Rep.- R-FL-21]; Committees: House – Energy and Commerce

 

H.R.3471 – To preempt States from establishing, implementing, or enforcing any ban on the prescription, provision, or use of a drug, biological product, or device for contraception if such drug, biological product, or device is approved, licensed, cleared, or otherwise authorized for human use by the Food and Drug Administration for contraception, and for other purposes; Sponsor: Bice, Stephanie I. [Rep.-R-OK-5]; Committees: House – Energy and Commerce

 

H.R.3481 – To provide paid family and medical leave benefits to certain individuals, and for other purposes; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Ways and Means

 

H.R.3498 – To facilitate nationwide accessibility and coordination of 211 services and 988 services in order to provide information and referral to all residents and visitors in the United States for mental health emergencies, homelessness needs, other social and human services needs, and for other purposes; Sponsor: Higgins, Brian [Rep.-D-NY-26]; Committees: House – Energy and Commerce

 

H.R.3503 – To direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes; Sponsor: Kelly, Robin L. [Rep.-D- IL-2]; Committees: House – Energy and Commerce

 

H.R.3520 – To improve the provision of care and services under the Veterans Community Care Program of the Department of Veterans Affairs, and for other purposes; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Veterans’ Affairs

 

H.R.3523 – To grow and diversify the perinatal workforce, and for other purposes; Sponsor: Moore, Gwen [Rep.-D-WI-4]; Committees: House – Energy and Commerce

 

H.R.3532 – To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes; Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Energy and Commerce; Rules

 

H.R.3548 – To address mental health issues for youth, particularly youth of color, and for other purposes; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Energy and Commerce

 

H.R.3549 – To amend title XVIII of the Social Security Act to ensure Medicare-only PACE program enrollees have a choice of prescription drug plans under Medicare part D; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3554 – To amend title 38, United States Code, to expand access to the Veterans Community Care Program of the Department of Veterans Affairs to include certain veterans seeking mental health or substance-use services, and for other purposes; Sponsor: Zinke, Ryan K. [Rep.-R-MT-1]; Committees: House – Veterans’ Affairs

The Senate Health, Education, Labor, and Pensions (HELP) Committee markup of four drug pricing related bills was postponed last week after a disagreement between panel Democrats and Republicans about the process by which the legislation was brought forth for consideration. Republicans argued that several amendments filed by Democrats contained policies that committee leadership agreed to set aside during their initial bipartisan negotiations on the package of bills, some of which had been awaiting scores from the Congressional Budget Office and technical assistance from federal agencies. HELP Committee members also questioned why the markup was taking place prior to a related hearing scheduled for May 10 in which the nation-s largest insulin manufacturers and pharmacy benefit managers have agreed to testify. The markup has been rescheduled for Thursday, May 11.

 

Appropriations Markups to Begin Mid-May

Senate Appropriations Chair Patty Murray (D-Wash.) announced plans for her panel to begin marking up fiscal year (FY) 2024 spending legislation on May 18th. Negotiations between Murray and Ranking Member Susan Collins (R-Maine) on top-line spending levels are still ongoing. House Appropriations Committee leadership recently announced its own FY 2024 appropriations markup schedule as well: the first subcommittee markups will be held May 17th and 18th, with the first full committee markups tentatively planned for May 23rd, 24th, and 25th. The remaining subcommittee markups will be held June 7th and 8th, with the full committee completing consideration of the measures June 13th, 14th, and 15th.

 

E&C Republicans Probe Viral Manipulation Research, CDC Reorganization

Top Republicans on the House Energy and Commerce Committee are asking the Government Accountability Office to evaluate the benefits and risks of predictive field research programs for viruses. The letter comes as a part of the panel-s investigation into the origins of COVID-19. The letter was signed by Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight and Investigations Subcommittee Chair Morgan Griffith (R-Va.). The lawmakers have also asked acting director of the National Institutes of Health (NIH) Lawrence Tabak to supply details about all internal and external NIH research projects involving virus manipulation.

Rodgers, Guthrie, and Griffith also sent a letter to the Centers for Disease Control and Prevention (CDC) requesting information related to its Moving Forward Initiative which has resulted in the agency undertaking a large-scale reorganization. The letter criticizes the CDC for conducting the initiative “largely in secret,” providing just a 10-day notice and comment period and only convening a single related public meeting. The agency used the findings of the Moving Forward Initiative to justify its request to Congress for additional authority to mandate data reporting from state, local, territorial, and tribal public health agencies. “The CDC must provide the Committee with more than a cursory, summarized overview of the findings of the Moving Forward Initiative before the Committee can even begin to consider the agency-s request for additional authority,” the lawmakers state.

 

Wyden, Matsui, McHenry Urge Bakers to Comply with Spirit of Sesame Labeling Law

Sen. Ron Wyden (D-Ore.), Rep. Doris Matsui (D-Calif.), and Rep. Patrick McHenry (R-N.C.) have sent a letter to the American Bakers Association urging its members to stop unnecessarily adding sesame to baked goods in order to protect consumers with a sesame allergy. “The dangerous practice of adding sesame to baked goods that have not previously contained the ingredient, often without notice, undermines the trust that people with food allergies place in the food industry,” the letter states. The lawmakers argue that “instead of acting to protect consumers, manufacturers are adding trace amounts of sesame to their baking products since the passage of the FASTER Act. It appears that this is being done to avoid the costs associated with the processes and systems controls necessary to ensure safe baking practices.” The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which became law in April 2021, requires manufacturers to ensure that products containing sesame are appropriately labeled.

 

Finance Committee Explores Prevalence of Mental Health Ghost Networks

The Senate Finance Committee released a ‘secret shopper- report last week which found that most Medicare Advantage plan mental health provider directories contain misleading or false contact information. In a study of directories across 12 different plans in six states, Finance majority staff found that more than 80% of mental health care providers listed as in- network were in fact not available to the plan-s enrollees. The report recommends increased oversight and audits of health plan directories, and suggests fining plans that do not have accurate directories. The committee released the report prior to a hearing on the prevalence of these so-called ghost networks on Wednesday, May 10.

 

Sen. Ben Cardin Will Not Seek Reelection

Sen. Ben Cardin (D-Md.), 79, announced last week that he will not seek re-election in 2024. Cardin was first elected to the Senate in 2006 following 17 years representing Maryland-s Third Congressional District in the House of Representatives. He currently serves as Chair of the Small Business and Entrepreneurship Committee and is a senior member of the Senate Foreign Relations, Finance, and Environment and Public Works committees. Rep. David Trone (D- Md.) and Montgomery County Council member Will Jawando (D) have announced that they will run for Cardin-s Senate seat, and Prince George-s County Executive Angela Alsobrooks (D) is also considering a bid in the 2024 election.

 

WHO Declares End of COVID-19 Global Health Emergency; U.S. PHE to End May 11

At the recommendation of the World Health Organization-s (WHO) COVID-19 Emergency Committee, WHO Director-General Tedros Adhanom Ghebreyesus has declared an end to COVID-19 as a Public Health Emergency of International Concern. WHO officials were careful to emphasize that while the emergency phase of the coronavirus pandemic is over, COVID-19 remains a global public health threat. “COVID has changed our world and it has changed us,” Tedros said. “If we all go back to how things were before COVID-19, we will have failed to learn our lessons and we will have failed future generations.”

As previously announced, the Biden administration will officially terminate the U.S. COVID-19 public health emergency (PHE) on May 11. The end of the PHE declaration will result in a restructured federal COVID-19 response that shifts much of the responsibility for vaccine and treatment distribution to the private sector. People without health insurance will continue to be able to access vaccines and treatments at no out-of-pocket cost through 2024. Vaccines will remain free in Medicare, Medicaid, and the Children-s Health Insurance Program, but beneficiaries of these programs could face increased cost sharing for COVID-19 tests and treatments. Certain other flexibilities and regulatory authorities instituted in response to the COVID-19 PHE have already been de-linked from the emergency declaration. The Consolidated Appropriations Act, 2023, for example, extended certain telehealth policies and hospital at home waivers through 2024.

Experts have warned that there is an approximately 20% chance of an outbreak rivaling the intensity of the omicron variant occurring in the next two years. It was reported last week that scientists shared their analysis of the possibility of the virus mutating in such a way that evades vaccines and treatments with the Biden administration as it was working to wind down the PHE. The White House declined to comment about the experts- analysis.

 

Walensky to Leave Post of CDC Director

Rochelle Walensky will leave her position as Director of the Centers for Disease Control and Prevention (CDC), a post she has held since the start of the Biden administration. During her time as director Walensky acknowledged the CDC-s shortcomings in response to the COVID-19 pandemic and launched an effort to reorganize and modernize the agency. Walensky plans to step down on June 30 but did not provide a reason behind her decision to resign.

 

Tanden Tapped as Next Head of the Domestic Policy Council

According to recent reports, President Joe Biden will soon name Neera Tanden as the next Director of the Domestic Policy Council. Tanden will replace Susan Rice, who has announced her plans to leave the administration later this month. Tanden currently serves as White House staff secretary and senior adviser. She was previously nominated to lead the Office of Management and Budget but withdrew from consideration after bipartisan objections to her use of Twitter to criticize political opponents. Biden aide Stef Feldman will replace Tanden as staff secretary.

 

DEA Temporarily Extends COVID-19 Telehealth Prescribing Flexibilities

The Drug Enforcement Administration (DEA) announced last week that it will continue to permit providers to prescribe controlled substances via telehealth as the agency works to finalize its related proposed regulations in response to the end of the COVID-19 public health emergency (PHE). The rules proposed in February would have allowed doctors to prescribe only an initial 30-day supply of certain DEA-regulated drugs through telehealth. For other drugs – including Adderall – patients would be required to complete an in-person visit with a provider before receiving a prescription. The DEA stated that it received a record number of comments in response to the proposed rules. It did not specify how long the temporary extension of the COVID-19 era flexibilities will last.

In related news, a bipartisan group of senators sent a letter to the DEA calling on the agency to address gaps in patient access to the opioid use disorder drug buprenorphine. “We are concerned that the DEA has failed to develop and provide sufficiently clear guidance for pharmacists, wholesalers, distributors, and patients for accessing buprenorphine,” the lawmakers said in a letter to the agency. The letter was signed by Sens. Maggie Hassan (D-N.H.), Martin Heinrich (D-N.M.), Thom Tillis (R-N.C.), Elizabeth Warren (D-Mass.) and Sheldon Whitehouse (D-R.I.).

New Survey Examines Impact of Pandemic on Nursing Shortages

Anew survey from AMN Healthcare reveals that nearly one-third of nurses nationwide will leave the profession because of the COVID-19 pandemic. The percentage of nurses saying they were satisfied with their choice of career dropped to 71% in 2023, after holding steady at 80% to 85% for the prior decade. The survey of 182,000 nurses also found a decline in the percentage of nurses who are satisfied with the quality of care they provide from 75% to 64%.

 

POLICY BRIEFINGS

 

Upcoming Congressional Hearings and Markups

House Ways and Means Committee field hearing on “Trade in America: Securing Supply Chains and Protecting the American Worker – Staten Island;” 10:00 a.m.; May 9

 

House Veterans- Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: Pharmacy;” 3:00 p.m.; May 9

 

House Transportation & Infrastructure Subcommittee on Highways and Transit hearing “Freight Forward: Overcoming Supply Chain Challenges to Deliver for America;” 10:00 a.m.; May 10

 

Senate Health, Education, Labor, and Pensions Committee hearing “The Need to Make Insulin Affordable for All Americans;” 1:00 p.m.; May 10

 

House Ways and Means Subcommittee on Health hearing on Examining Policies that Inhibit Innovation and Patient Access; 2:00 p.m.; May 10

 

House Select Subcommittee on the Coronavirus Pandemic hearing “Investigating Pandemic Immunity: Acquired, Therapeutic or Both;” 10:00 a.m.; May 11

 

Senate Health, Education, Labor, and Pensions Committee markup of S. 1067, Ensuring Timely Access to Generics Act of 2023, S. 1114, Expanding Access to Low-Cost Generics Act of 2023, S. 1214, RARE Act, and S. 1339, Pharmacy Benefit Manager Reform Act; 10:00 a.m.; May 11

 

House Energy and Commerce Subcommittee on Health hearing “Preparing for and Responding to Future Public Health Security Threats;” 10:00 a.m.; May 11

 

Senate Finance Committee hearing “Cross-border Rx: Pharmaceutical Manufacturers and U.S. International Tax Policy;” 10:00 a.m.; May 11

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains;” 10:30 a.m.; May 11

 

House Transportation & Infrastructure Subcommittee on Railroads, Pipelines, and Hazardous Materials hearing “Getting Back on Track: Exploring Rail Supply Chain Resilience and Challenges;” 2:00 p.m.; May 11

 

House Oversight and Accountability Subcommittee on Health Care and Financial Services hearing “FDA Oversight Part II: Responsibility for the Infant Formula Shortage;” 2:00 p.m.; May 11

 

Recently Introduced Health Legislation

 

H.R.3030 – To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, and for other purposes. Sponsor: Sorensen, Eric [Rep.-D-IL-17]; Committees: House – Energy and Commerce

 

H.R.3029 – To amend the Internal Revenue Code of 1986 to allow individuals with direct primary care service arrangements to remain eligible individuals for purposes of health savings accounts, and for other purposes. Sponsor: Smucker, Lloyd [Rep.-R-PA-11]; Committees: House – Ways and Means

 

H.R.3024 – To amend the Family and Medical Leave Act of 1993 to permit additional leave for bone marrow or blood stem cell donation, and for other purposes. Sponsor: Phillips, Dean [Rep.-D-MN-3]; Committees: House – Education and the Workforce; Oversight and Accountability; House Administration

 

H.R.3023 – To direct the Secretary of Veterans Affairs and the Secretary of Defense to furnish stellate ganglion block to veterans and members of the Armed Forces with post-traumatic stress disorder, and for other purposes. Sponsor: Perry, Scott [Rep.-R-PA-10]; Committees: House – Armed Services; Veterans- Affairs

 

H.R.3017 – To amend title XVIII of the Social Security Act to improve access to skilled nursing facilities for primary immunodeficiency patients. Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.3011 – To establish a task force of the Department of Defense on mental health. Sponsor: Kilmer, Derek [Rep.-D- WA-6]; Committees: House – Armed Services

 

H.R.3009 – To direct the Secretary of Defense to carry out a pilot program to pre-program suicide prevention resources into certain smart devices issued to members of the Armed Forces. Sponsor: Joyce, David P. [Rep.-R-OH-14]; Committees: House – Armed Services

 

H.R.3008 – To amend the Federal Food, Drug, and Cosmetic Act to provide for notification by manufacturers of critical essential medicines of increased demand of such drugs, and for other purposes. Sponsor: Jacobs, Sara [Rep.-D-CA-51]; Committees: House – Energy and Commerce

 

H.R.3004 – To amend the Internal Revenue Code of 1986 to provide for a temporary expansion of health insurance premium tax credits for certain low-income populations, and to amend title XIX of the Social Security Act to establish a Federal Medicaid program. Sponsor: Fletcher, Lizzie [Rep.-D-TX-7]; Committees: House – Ways and Means; Energy and Commerce

 

H.Res.347 – Expressing support for designation of the mouth of April 2023 as “Parkinson-s Awareness Month”. Sponsor: Wexton, Jennifer [Rep.-D-VA-10]; Committees: House – Energy and Commerce

 

H.Res.345 – Recognizing that infertility is a widespread problem that affects populations of diverse ages, races, ethnicities, and genders. Sponsor: Wasserman Schultz, Debbie [Rep.-D-FL-25]; Committees: House – Energy and Commerce

 

H.Res.338 – 118th Congress (2023-2024) Expressing support for the designation of April 30, 2023, as “National Adult Hepatitis B Vaccination Awareness Day”. Sponsor: Johnson, Henry C. “Hank,” Jr. [Rep.-D-GA-4]; Committees: House – Energy and Commerce

 

S.1395 – A bill to temporarily suspend the debt limit through December 31, 2024; Sponsor: Schumer, Charles E. [Sen.- D-NY]; Latest Action: Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.

 

S.1403 – A bill to amend the Public Health Service Act to establish a grant program to award grants to accredited public institutions of higher education, and for other purposes; Sponsor: Mullin, Markwayne [Sen.-R-OK]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.348 – Declaring gun violence a public health crisis; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House – Energy and Commerce

 

H.Res.351 – Recognizing the impact the stigmatization of menstruation has on the lives of women, girls, and people who menstruate, and expressing support for the designation of the month of May as “National Menstrual Health Awareness Month”; Sponsor: Meng, Grace [Rep.-D-NY-6]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.Res.355 – Supporting the designation of May 2023 as “National Brain Tumor Awareness Month”; Sponsor: Quigley, Mike [Rep.-D-IL-5]; Committees: House – Energy and Commerce

 

H.R.3055 – To amend the Elementary and Secondary Education Act of 1965 to include certain mental health professionals as specialized instructional support personnel; Sponsor: Harder, Josh [Rep.-D-CA-9]; Committees: House – Education and the Workforce

 

H.R.3065 – To amend the Public Health Service Act to provide funding for trained school personnel to administer drugs and devices for emergency treatment of known or suspected opioid overdose, and for other purposes; Sponsor: Phillips, Dean [Rep.-D-MN-3]; Committees: House – Energy and Commerce

 

H.R.3066 – To establish the National Commission on the COVID-19 Pandemic, and for other purposes; Sponsor: Posey, Bill [Rep.-R-FL-8]; Committees: House – Energy and Commerce; Financial Services; Transportation and Infrastructure

 

H.R.3068 – To prohibit discrimination in health care and require the provision of equitable health care, and for other purposes; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3069 – To amend title XI of the Social Security Act to improve access to care for all Medicare and Medicaid beneficiaries through models tested under the Center for Medicare and Medicaid Innovation, and for other purposes; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.3073 – To amend the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to promote mental wellness and resilience and prevent and heal mental health, behavioral health, and psychosocial conditions through developmentally and culturally appropriate community programs, and award grants for the purpose of establishing, operating, or expanding community-based mental wellness and resilience programs, and for other purposes; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

H.R.3074 – To amend title XIX of the Social Security Act to remove the Medicaid coverage exclusion for inmates in custody pending disposition of charges, and for other purposes; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Energy and Commerce

 

H.R.3076 – To amend title 36, United States Code, to direct the Secretary of Veterans Affairs to establish a flag for next of kin of veterans who die by suicide; Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House – Judiciary

 

H.R.3077 – To amend title 38, United States Code, to establish a counseling program for certain survivor of veterans deceased as the result of suicide; Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House – Veterans- Affairs

 

S.1423 – A bill to amend the Public Health Service Act to authorize a scholarship and loan repayment program to incentivize physicians to enter into the field of sickle cell disease research, treatment, and patient care, and for other purposes; Sponsor: Van Hollen, Chris [Sen.-D-MD]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1424 – A bill to amend title XXVII of the Public Health Service Act to improve health care coverage under vision and dental plans, and for other purposes; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1426 – A bill to improve the identification and support of children and families who experience trauma; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1436 – A bill to expand and extend benefits available to veterans in response to the COVID-19 pandemic, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans- Affairs

 

S.Res.197 – A resolution designating the week of May 1, 2023, through May 7, 2023, as “Tardive Dyskinesia Awareness Week”; Sponsor: Mullin, Markwayne [Sen.-R-OK]; Committees: Senate – Judiciary

 

S.1441 – A bill to establish a Center for Biomedical Innovation and Development in order to accelerate innovation and development of advanced medical countermeasure products; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1446 – A bill to amend the Internal Revenue Code of 1986 to exclude certain Nurse Corps payments from gross income; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Finance

 

S.1447 – A bill to amend the Public Health Service Act to establish a grant program supporting trauma center violence intervention and violence prevention programs, and for other purposes; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1450 – A bill to establish a cap on costs for covered prescription drugs under Medicare parts B and D; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Finance

 

S.1451 – A bill to band anticompetitive terms in facility and insurance contracts that limit access to higher quality, lower cost care; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1452 – A bill to promote mental wellness and resilience and prevent and heal mental health, behavioral health, and psychosocial conditions through developmentally and culturally appropriate community programs, and award grants for the purpose of establishing, operating, or expanding community-based mental wellness and resilience programs, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

House Passes GOP Debt Ceiling Bill Along Party Lines

The House of Representatives passed the GOP leadership’s legislative proposal to raise the debt ceiling last week in a 217-215 vote. Four Republicans – Matt Gaetz (Fla.), Andy Biggs (Ariz.), Ken Buck (Colo.), and Tim Burchett (Tenn.) – joined Democrats in opposition to the measure. The Limit, Save, Grow Act of 2023 (H.R. 2811) would lift the nation’s $34.1 trillion debt limit by $1.5 trillion or until March 31, 2024, whichever comes first, in exchange for $130 billion in proposed budget cuts. The bill would achieve these cuts by freezing discretionary spending at fiscal year (FY) 2022 levels – $1.47 trillion. Any future spending increases would be capped at 1% annually for the next decade, reaching $1.61 trillion in total discretionary spending in FY 2033. The bill would permit new budget authority only for certain activities, including health care fraud and abuse prevention. The legislation also includes provisions to claw back unspent and unobligated COVID-19 funding and to institute work requirements for social safety net programs. Medicaid recipients would be required to work, look for work, or participate in community engagement for 80 hours a month, exempting those with dependent children and those who are “physically or mentally unfit,” enrolled in an educational program, under 19 years old, or over 56 years old. The Congressional Budget Office estimates that the bill would reduce the federal deficit by $4.8 trillion over the next decade. The Medicaid work requirement proposal would reduce federal spending by $109 billion, with the budget office forecasting that 1.5 million adults would lose federal funding for their Medicaid coverage. Approximately 900,000 of those individuals would retain their health insurance coverage through Medicaid state funding, while 600,000 would become uninsured. H.R. 2811 has been rejected by congressional Democrats and the White House in favor of a clean increase to the debt limit, with Majority Leader Chuck Schumer (D-N.Y.) characterizing the bill as dead on arrival in the Senate and the White House confirming that the President would veto the legislation should it reach his desk. Without an increase or suspension of the debt ceiling, the nation could default on its payment obligations as early as June.

 

HELP to Markup Four Drug Pricing Bills This Week

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) and Ranking Member Bill Cassidy (R-La.) have announced a bipartisan deal to consider a slate of drug pricing related proposals. The four bills will be marked up by the panel on Tuesday. The committee will consider:

• The RARE Act (S. 1214), to codify that the scope of orphan drug exclusivity aligns with the approved use or indication of an orphan drug, rather than the disease or condition for which the drug received orphan drug designation.
• The Ensuring Timely Access to Generics Act of 2023 (S. 1067), which would permit the FDA to deny a citizen petition submitted with the primary purpose of delaying the approval of a follow-on generic or biosimilar application, or if the petition does not raise valid scientific or regulatory issues.
• The Expanding Access to Low-Cost Generics Act of 2023 (S. 1114), to allow generic companies that are not “first filers” to enter the market if the first filer who otherwise received 180-day exclusivity has failed to come to market by 33 months since the date of submission of the application when there is another applicant who is otherwise ready to market their product.
• The Pharmacy Benefit Manager Reform Act (S. 1339), which would increase oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage.

Senate Majority Leader Chuck Schumer (D-N.Y.) aims to bring a drug pricing package to the floor this year. The Senate Commerce, Judiciary, and Finance committees are also working to pass their own drug pricing proposals, and Sanders has stated that he expects to see several of the related bills merged when they reach the Senate floor.

 

House Appropriations Markups to Commence May 17th

The House Appropriations Committee will begin conducting markups of FY 2024 spending bills later this month. According to a letter from Chairwoman Kay Granger (R-Texas) to panel members, the first subcommittee markups will be scheduled for May 17th and 18th, with the first full committee markups tentatively planned for May 23rd, 24th, and 25th. The remaining subcommittee markups will be held June 7th and 8th, with the full committee completing consideration of the measures June 13th, 14th, and 15th.

 

Senate Republicans Block VA Cannabis Research Proposal

The Senate blocked consideration of legislation last week that would have directed the Department of Veterans Affairs (VA) to conduct research on the effects of cannabis on patients in the VA health care system suffering from trauma, stress, chronic pain, and opioid use disorder. The VA Medicinal Cannabis Research Act (S. 326), introduced by Sens. Jon Tester (D-Mont.) and Dan Sullivan (R-Alaska), was unanimously passed out of committee earlier this year but failed in a 57-42 procedural motion that required 60 votes to advance on the Senate floor. Eight Republicans joined Democrats in support of the bill: Veterans’ Affairs Committee members Jerry Moran (Kansas), Bill Cassidy (La.), Mike Rounds (S.D.), and Dan Sullivan (Alaska), along with Susan Collins (Maine), Lisa Murkowski (Alaska), Josh Hawley (Mo.), and Eric Schmitt (Mo.).

 

Warren, Jayapal Make Drug Pricing Recommendations for USPTO

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) have sent a letter to the U.S. Patent and Trademark Office (USPTO) reiterating their request that the agency take action against alleged efforts by pharmaceutical manufacturers to prevent generic competition from coming to market. “We have yet to see the USPTO take substantial steps to exercise its existing administrative authorities to help lower drug prices, encourage competition, and increase innovation,” the letter states. The lawmakers sent similar letters to the agency in June 2021 and December 2022. Warren and Jayapal specifically urge the USPTO to consider the following recommendations:

• Revise the practice of granting obvious patents;
• When challenged, patents tied together by terminal disclaimers should all stand or fall together;
• Raise filing fees and limit the number and time period for continuation applications to discourage “obviousness-type double patents;”
• Require applicants to disclose at the time of filing whether the drug compound covered by the patent application is in clinical trials;
• Reverse policies that have led to an increase in discretionary denials of petitions filed through the inter partes review process; and
• Establish an office dedicated to building public transparency, serving the public interest, and strengthening interagency communication.

 

Coronavirus Select Subcommittee Requests Intel from Chinese Scientists

Republicans on the House Select Subcommittee on the Coronavirus Pandemic have asked the Chinese embassy to permit five Chinese scientists to be interviewed about how the coronavirus pandemic started. The request comes in response to the Chinese embassy’s opposition to a recent subcommittee hearing regarding the origins of COVID-19. “Continued stonewalling by China will not only harm the globe’s ability to predict, prepare, protect, and prevent the next pandemic but will also…fail to promote ‘international solidarity,'” the letter states. The committee asks to hear from Dr. George Gao, former director of the Chinese Center for Disease Control and Prevention; Dr. Shi Zhengli, director of the Center for Emerging Infectious Diseases, the Wuhan Institute of Virology; Dr. Ben Hu, a researcher with the Wuhan Institute of Virology; and Dr. Chen Wei, Major General of the People’s Liberation Army.

 

E&C Republicans Launch Probe into NIH Communications Spending

House Energy and Commerce Committee Republicans have launched an investigation into spending by the National Institutes of Health (NIH) on public information and communication services. The NIH has spent nearly $1 billion over the last five years on public relations contracts. The committee sent letters to the 10 communications and consulting firms awarded a contract in 2018 that is due to expire in December to request more information about their work for NIH. “Government contracts for public relations, consulting, and media services can devolve into a kind of de facto public relations service for the personal aggrandizement of senior leadership. They can be used to promote an agency’s brand and image instead of being used to communicate accurate information to the public,” the letter states. The panel aims to determine how the agency uses contract public relations firms and whether they are an appropriate use of taxpayer dollars.

 

Physicians Consider Impact of Potential Mifepristone Restrictions on Off-Label Prescribing

Physicians across the country are working to determine the impact of recent legal rulings related to the accessibility of mifepristone on their prescribing practices. Earlier this month, the Supreme Court acted to prevent lower court rulings suspending access to mifepristone from taking effect. Mifepristone is approved by the Food and Drug Administration (FDA) for abortion, though it is frequently prescribed off-label for miscarriage management. The U.S. 5th Circuit Court of Appeals will hear arguments on May 17 from anti-abortion groups in support of overturning the FDA’s approval of mifepristone and counterarguments from the Biden administration and the pill’s manufacturer seeking to maintain access to the pill nationwide. The 5th Circuit’s prior ruling would have kept the drug on the market but restricted access to telemedicine prescriptions, mail delivery, pharmacy dispensing, and generic versions of the drug and only permitted prescriptions within seven weeks of gestation. Meanwhile, a separate federal court ruling from Washington state could shield some states and the District of Columbia from any attempts to restrict mifepristone availability. While some legal experts assert that any future restrictions on the medication abortion pill could be circumvented by prescribing the drug off-label, many prescribers are concerned about the possibility of prosecution, harassment, and retaliation from state licensing boards and civil litigation. “We don’t feel at all comfortable,” American Medical Association President Jack Resneck stated in an interview. “Off-label prescribing is common, but it is really unclear in this case what physicians would be able to do.”

 

Upcoming Congressional Hearings and Markups

 

Senate Health, Education, Labor, and Pensions Committee markup of S. 1067, Ensuring Timely Access to Generics Act of 2023, S. 1114, Expanding Access to Low-Cost Generics Act of 2023, S. 1214, RARE Act, and S. 1339, Pharmacy Benefit Manager Reform Act; 10:00 a.m.; May 2

 

Senate Finance Committee hearing “Barriers to Mental Health Care: Improving Provider Directory Accuracy to Reduce the Prevalence of Ghost Networks;” 10:00 a.m.; May 3

 

Senate Veterans’ Affairs Committee hearing “Examining the Effectiveness of the Office of Integrated Veteran Care;” 3:00 p.m.; May 3

 

Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education, and Related Agencies hearing “Fiscal Year 2024 budget for the National Institutes of Health;” 10:00 a.m.; May 4

 

Senate Health, Education, Labor, and Pensions Committee hearing “Preparing for the Next Public Health Emergency: Reauthorizing the Pandemic and All-Hazards Preparedness Act;” 1:00 p.m.; May 4

 

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: Pharmacy;” 3:00 p.m.; May 9

 

Senate Health, Education, Labor, and Pensions Committee hearing “The Need to Make Insulin Affordable for All Americans;” 1:00 p.m.; May 10

 

 

POLICY BRIEFINGS

 

Recently Introduced Health Legislation

H.R.2804 – To amend the Controlled Substances Act with respect to the registration of opioid treatment programs to increase stakeholder input from relevant communities and to ensure such programs are treating patients in need, and for other purposes; Sponsor: Espaillat, Adriano [Rep.-D-NY-13]; Committees: House – Energy and Commerce; Judiciary

 

H.R.2809 – To authorize an electronic health record modernization program of the Department of Veterans Affairs and increase oversight and accountability of the program to better serve veterans, medical professionals of the Department, and taxpayers, and for other purposes; Sponsor: Takano, Mark [Rep.-D-CA-39]; Committees: House – Veterans’ Affairs; Armed Services

 

S.Res.170 – A resolution supporting the goals and ideals of World Malaria Day; Sponsor: Wicker, Roger F. [Sen.-R-MS]; Committees: Senate – Foreign Relations

 

S.1262 – A bill to amend title 5, United States Code, to require Federal employee health benefit plans to include assisted reproductive treatment benefits, and for other purposes; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Homeland Security and Governmental Affairs

 

S.1264 – A bill to amend title XVIII of the Social Security Act to strengthen the drug pricing reforms in the Inflation Reduction Act; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Finance

 

S.1269 – A bill to reduce the price of insulin and provide for patient protections with respect to the cost of insulin; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.2813 – To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to exclude from the definition of health insurance coverage certain medical stop-loss insurance obtained by certain plan sponsors of group health plans, and for other purposes; Sponsor: Good, Bob [Rep.-R- VA-5]; Committees: House – Education and the Workforce; Energy and Commerce; Ways and Means

 

H.R.2816 – To amend title XI of the Social Security Act to strengthen transparency requirements with respect to pharmacy benefit managers; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2818 – To amend title 38, United States Code, to increase the amount paid by the Secretary of Veterans Affairs to veterans for improvements and structural alterations furnished as part of home health services; Sponsor: Bacon, Don [Rep.-R-NE-2]; Committees: House – Veterans’ Affairs

 

H.R.2819 – To amend the Public Health Service Act to limit the liability of health care professionals who volunteer to provide health care services in response to a disaster; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Energy and Commerce; Judiciary

 

H.R.2828 – To require Federal employee health benefit plans to include assisted reproductive treatment benefits, and for other purposes; Sponsor: Connolly, Gerald E. [Rep.-D-VA-11]; Committees: House – Oversight and Accountability

 

H.R.2829 – To amend title XVIII of the Social Security Act to remove cost-sharing responsibilities for chronic care management services under the Medicare program; Sponsor: Duncan, Jeff [Rep.-R-SC-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2852 – To require the Secretary of Defense to provide to firefighters of the Department of Defense medical testing and related services to detect and prevent certain cancers; Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

 

H.R.2853 – To amend title XVIII of the Social Security Act to expand access to clinical care in the home, and for other purposes; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2854 – To require the Administrator of the United States Agency for International Development to submit a report on progress relating to malaria reduction, and for other purposes; Sponsor: Smith, Christopher H. [Rep.-R-NJ-4]; Committees: House – Foreign Affairs

 

H.R.2857 – To direct the Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services to conduct an annual study on health care competition and consolidation at the State level; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Energy and Commerce

 

H.R.2858 – To amend the Pension Funding Equity Act of 2004 to repeal the antitrust exemption applicable to graduate medical resident matching programs; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Judiciary

 

H.R.2859 – To amend the Internal Revenue Code of 1986 to establish new community benefit standards for tax-exempt hospital organizations, and for other purposes; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Ways and Means

 

H.R.2860 – To amend title XVIII of the Social Security Act to repeal the Obamacare ban on provider-owned hospitals, and for other purposes; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2861 – To require the Government Accountability Office to evaluate the effects of anticompetitive contracting clauses in contracts between health insurers and health care providers and to determine actions taken by the Federal Trade Commission and the Department of Justice relating to the use of such clauses in such contracts and to assess their ability to effectively enforce the Federal antitrust laws with respect to such use; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Energy and Commerce; Judiciary

 

H.R.2862 – To eliminate the inpatient-only service list; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2863 – To amend title XVIII of the Social Security Act and title XXVII of the Public Health Service Act to address incorrect billing by off-campus hospital locations, and for other purposes; Sponsor: Spartz, Victoria [Rep.-R-IN-5]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2867 – To establish an awareness campaign related to the lethality of fentanyl and fentanyl-contaminated drugs, to establish a Federal Interagency Work Group on Fentanyl Contamination of Drugs, and to provide community-based coalition enhancement grants to mitigate the effects of drug use; Sponsor: Trone, David J. [Rep.-D-MD-6]; Committees: House – Energy and Commerce

 

H.R.2868 – To amend the Employee Retirement Income Security Act of 1974 to clarify the treatment of certain association health plans as employers, and for other purposes; Sponsor: Walberg, Tim [Rep.-R-MI-5]; Committees: House – Education and the Workforce

 

S.1294 – A bill to provide for payment rates for durable medical equipment under the Medicare program; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

S.1296 – A bill to amend title XI of the Social Security Act to improve access to care for all Medicare and Medicaid beneficiaries through models tested under the Center for Medicare and Medicaid Innovation, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Finance

 

S.1297 – A bill to ensure the right to provide reproductive health care services, and for other purposes; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Judiciary

 

S.1298 – A bill to award grants for the creation, recruitment, training and education, retention, and advancement of the direct care workforce and to award grants to support family caregivers; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1302 – A bill to amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Finance

 

S.1315 – A bill to improve the provision of care and services under the Veterans Community Care Program of the Department of Veterans Affairs, and for other purposes; Sponsor: Moran, Jerry [Sen.-R-KS]; Committees: Senate – Veterans’ Affairs

 

S.1317 – A bill to amend the Public Health Service Act to provide for public health research and investment into understanding and eliminating structural racism and police violence; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.2880 – To amend title XVIII of the Social Security Act to establish certain requirements for pharmacy benefit managers under part D of the Medicare program; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2884 – To facilitate direct primary care arrangements under Medicaid; Sponsor: Crenshaw, Dan [Rep.-R-TX-2]; Committees: House – Energy and Commerce

 

H.R.2890 – To amend the Federal Trade Commission Act to make hospital organizations and cooperative hospital service organizations subject to the law relating to unfair methods of competition; Sponsor: Jayapal, Pramila [Rep.-D-WA-7]; Committees: House – Judiciary

 

H.R.2893 – To amend title XVIII of the Social Security Act to provide for certain rules regarding the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost-sharing subsidies under part D of the Medicare program, and for other purposes; Sponsor: Lee, Susie [Rep.-D-NV-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.2904 – To amend the Public Health Service Act to provide for public health research and investment into understanding and eliminating structural racism and police violence; Sponsor: Pressley, Ayanna [Rep.-D-MA-7]; Committees: House – Energy and Commerce

 

H.R.2907 – To ensure the right to provide reproductive health care services, and for other purposes; Sponsor: Schrier, Kim [Rep.-D-WA-8]; Committees: House – Energy and Commerce; Judiciary

 

H.R.2914 – To amend the Internal Revenue Code of 1986 to extend the health coverage tax credit; Sponsor: Turner, Michael R. [Rep.-R-OH-10]; Committees: House – Ways and Means

 

S.Res.180 – A resolution expressing support for the designation of April 30, 2023, as “National Adult Hepatitis B Vaccination Awareness Day”; Sponsor: Hirono, Mazie K. [Sen.-D-HI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.184 – A resolution expressing support for the designation of April 2023 as “Parkinson’s Awareness Month”; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1333 – A bill to authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants for providing evidence-based caregiver skills training to family caregivers of children with autism spectrum disorder or other developmental disabilities or delays, and for other purposes; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1339 – A bill to provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1346 – A bill to authorize the Secretary of Health and Human Services, acting through the Director of the Center for Mental Health Services of the Substance Abuse and Mental Health Services Administration, to award grants to implement innovative approaches to securing prompt access to appropriate follow-on care for individuals who experience an acute mental health episode and present for care in an emergency department, and for other purposes; Sponsor: Capito, Shelley Moore [Sen.-R-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1347 – A bill to amend title 10, United States Code, to waive cost-sharing under the TRICARE program for three mental health outpatient visits per year for certain beneficiaries, and for other purposes; Sponsor: Ossoff, Jon [Sen.-D-GA]; Committees: Senate – Armed Services

 

S.1355 – A bill to establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections, and for other purposes; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1360 – A bill to require the Secretary of Defense to include exposure to perfluoroalkyl substances and polyfluoroalkyl substances in periodic health assessments of members of the Armed Forces, and for other purposes; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Armed Services

 

S.1367 – A bill to amend XIX of the Social Security Act to cover physician services delivered by podiatric physicians to ensure access by Medicaid beneficiaries to appropriate quality foot and ankle care, to amend title XVIII of such Act to modify the requirements for diabetic shoes to be included under Medicare, and for other purposes; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

 

S.1373 – A bill to increase access to medication for opioid overdose reversal, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1374 – A bill to prohibit group health plans and health insurance issuers from entering into contracts that would prevent or restrict patient access to drug pricing information otherwise available through consumer decision-support tools; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1375 – A bill to amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.1378 – A bill to amend title XVIII of the Social Security Act to provide incentives for behavioral health integration under the Medicare program; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Finance

 

S.1384 – A bill to promote and protect from discrimination living organ donors; Sponsor: Gillibrand, Kirsten E. [Sen.-D- NY]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.333 – Expressing support for designation of April as “National Donate Life Month” and expressing gratitude to all Americans who have registered to be organ and tissue donors; Sponsor: Costa, Jim [Rep.-D-CA-21]; Committees: House – Energy and Commerce

 

H.R.2923 – To promote and protect from discrimination living organ donors; Sponsor: Nadler, Jerrold [Rep.-D-NY-12]; Committees: House – Energy and Commerce; Oversight and Accountability; House Administration; Education and the Workforce; Financial Services

 

H.R.2935 – To amend title 10, United States Code, to extend the period during which certain survivors of a member of the Selected Reserve are eligible for health benefits under TRICARE Reserve Select; Sponsor: Courtney, Joe [Rep.-D-CT-2]; Committees: House – Armed Services

 

H.R.2940 – To amend title III of the Public Health Service Act to establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections, and for other purposes; Sponsor: Ferguson, A. Drew, IV [Rep.-R-GA-3]; Committees: House – Energy and Commerce; Oversight and Accountability; Ways and Means; Budget

 

H.R.2959 – To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes; Sponsor: LaTurner, Jake [Rep.-R-KS-2]; Committees: House – Ways and Means; Judiciary; Energy and Commerce

 

H.R.2965 – To authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants for providing evidence-based caregiver skills training to family caregivers of children with autism spectrum disorder or other developmental disabilities or delays, and for other purposes; Sponsor: Meng, Grace [Rep.-D-NY-6]; Committees: House – Energy and Commerce

 

H.R.2977 – To direct the Secretary of Health and Human Services to award grants for the purpose of establishing, operating, or expanding one-stop crisis facilities, and for other purposes; Sponsor: Smith, Adam [Rep.-D-WA-9]; Committees: House – Energy and Commerce; Financial Services; Judiciary

 

H.R.2986 – To amend the Internal Revenue Code of 1986 to provide a deduction for certain charity care furnished by physicians, and for other purposes; Sponsor: Webster, Daniel [Rep.-R-FL-11]; Committees: House – Ways and Means