The Senate voted unanimously last week to require Director of National Intelligence Avril Haines to declassify information about the origins of the coronavirus pandemic. Passage of the COVID-19 Origin Act (S. 619) follows a recent report from the Department of Energy which concluded with ‘low confidence’ that COVID-19 most likely originated from a lab leak in China. Director of the Federal Bureau of Investigation (FBI) Christopher Wray separately acknowledged on Tuesday the FBI’s determination that the pandemic had most likely come from a laboratory incident in Wuhan.

 

HELP Leadership Seek Information on Health Care Workforce Shortages

Senate Health, Education, Labor, and Pensions Committee (HELP) Chair Bernie Sanders (I-Vt.) and Ranking Member Bill Cassidy (R-La.) have sent a letter to health care stakeholders requesting input on the drivers of current health care workforce shortages and possible legislative solutions to the problem. HELP Committee leadership have repeatedly stated their intent to prioritize health care worker shortages as an area of bipartisan compromise, with the panel holding its first hearing of the 118th Congress on the subject last month. The letter states their plan to use the information received to draft bipartisan legislation to strengthen workforce capacity. Sanders and Cassidy request responses be sent to HealthWorkforceComments @help.senate.gov no later than Monday, March 20.

 

Hudson, Eshoo Release RFI on PAHPA Reauthorization

House Energy and Commerce Committee members Reps. Richard Hudson (R-N.C.) and Anna Eshoo (D-Calif.) have released a request for information (RFI) on improving the nation’s biosecurity and preparedness infrastructure. The RFI comes as the lawmakers begin work to reauthorize the Pandemic and All Hazards Preparedness Act (PAHPA). Current authority for the program expires on September 30. “As I lead the process with my colleague, Rep. Eshoo, to improve our preparedness, I am seeking feedback and suggestions on how our country can be better prepared, further equipped, more transparent, and fully accountable when taking on future emergencies,” Rep. Hudson stated. Responses to the RFI are due by Monday, March 13.

 

Ways and Means Republicans Release Oversight Priorities

House Committee on Ways and Means Chair Jason Smith (R-Mo.) released his priorities for oversight hearings and related activities that the committee and its subcommittees plan to conduct over the course of the 118th Congress. Matters under the committee’s health care jurisdiction include oversight of the No Surprises Act implementation, oversight of the implementation of prescription drug provisions in the Inflation Reduction Act, adequacy and appropriateness of Medicare provider reimbursements, oversight of graduate medical education policies, and oversight of existing and proposed health care price transparency requirements. The plan also highlights concerns related to the delivery of health services and Medicare reimbursement.

 

Oversight Panel Launches Investigation into Role of PBMs

The House Committee on Oversight and Accountability has launched an investigation into the business practices of pharmacy benefit managers (PBMs) and their impact on patients, the nation’s pharmaceutical market, and overall health care costs. “Pharmacy benefit managers’ anticompetitive tactics are driving up health care costs for Americans and harming patient care,” Chair James Comer (R-Ky.) stated. “Federal agencies administering health care programs for seniors, active-duty military, and federal employees rely on PBMs as middlemen to set drug prices, which opens the door to government waste at the expense of American taxpayers.” Comer has requested information from the Office of Personnel Management, Centers for Medicare and Medicaid Services, and the Defense Health Agency on how government- administered health programs are affected by PBMs. He has also requested information from the nation’s three largest PBMs – Express Scripts, CVS Caremark, and OptumRx, about their business practices, including details on the total rebates and fees collected by the companies.

 

Bipartisan Bill Reintroduced to Encourage Prescription Drug Competition

On March 1, Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.), members of the Senate Health, Education, Labor, and Pensions (HELP) Committee, reintroduced the Prescription Drug Competition Act (S. 574). The Food and Drug Administration (FDA) may require drug manufacturers to have a Risk Evaluation and Mitigation Strategy (REMS) program to ensure the benefits of a drug with potential safety concerns outweigh the risks. However, as reported in the New York Times, drug manufacturers may patent their respective REMS programs and then leverage those patents to prevent alternative medications from entering the market. To address this, S. 574 would allow FDA to approve a generic medication immediately (avoiding the current 30-month stay) if the only impediment in the approval process is the reference product’s REMS patent. The legislation also includes provisions that would allow the continued sale of a generic medication facing litigation over a REMS patent. The legislation has been referred to the Senate HELP Committee.

 

POLICY BRIEFINGS

 

Lawmakers React to Elli Lilly’s Insulin Pricing Announcement

Eli Lilly announced last week that it will reduce the list price of its insulin products and cap patients’ out-of-pocket costs at $35 a month. The move was praised by Sen. Patty Murray (D-Wash.) who characterized it as “a critical step forward” but “long overdue.” Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-Vt.) subsequently sent letters to Sanofi and Novo Nordisk calling on the companies to lower the prices of their insulin products as well. He also previewed plans to introduce legislation to cap insulin costs at $20 per vial.

 

E&C Republicans Express Opposition to 2024 NBPP

Republican leadership of the House Committee on Energy and Commerce have sent a letter to the Biden administration expressing concerns with the 2024 Notice of Benefit and Payment Parameters (NBPP), which proposes to limit the number of plans that an issuer may offer in the Affordable Care Act marketplace that do not meet certain specifications. The U.S. Department of Health and Human Services estimates that the proposed regulation could result in the termination of 57% of plans on the federal platform – ultimately impacting 2.7 million Americans. “Despite once declaring that, ‘excessive market concentration threatens basic economic liberties,’ President Biden wants to drastically limit Americans’ choices in the health insurance market. In fact, under his latest rule, more than half of all Obamacare plans on the federal exchange would disappear,” the letter states. The lawmakers urge the administration to immediately abandon the proposal and advance policies that “discourage provider consolidation or improve transparency of health care prices to empower individuals and employers when purchasing health care.” The letter was signed by Committee Chair Cathy McMorris Rodgers (R-Wash.), Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-Va.), and Subcommittee on Health Chair Brett Guthrie (R-Ky.).

 

Ohio Senators Urge Health Surveys in East Palestine

Sens. Sherrod Brown (D-Ohio) and J.D. Vance (R-Ohio) have sent a letter to the Centers for Disease Control and Prevention and the Environmental Protection Agency urging the administration to undertake both immediate and long-term health surveys of individuals residing near the recent train derailment in East Palestine as soon as possible. The lawmakers argue that such surveys and assessments are needed to establish a medical baseline for the community exposed to the hazardous chemicals released in the derailment. “The residents of East Palestine and the surrounding community deserve to know if their health has been compromised by this disaster now and for years to come,” the letter states. “Therefore, we urge you to work with your colleagues across the federal government to allocate the resources and expertise needed to begin the surveys and assessment needed to establish a medical baseline for the community.”

 

FY 2024 Appropriations Update

Senate appropriations leadership announced plans to begin marking up fiscal year (FY) 2024 appropriations bills in May. Chair Patty Murray (D-Wash.) and Ranking Member Susan Collins (R-Maine) told panel members that they are currently negotiating a topline spending target that can be used in drafting the 12 annual spending bills. The Senate Appropriations Committee did not mark up any FY 2023 appropriations legislation last year.

House Appropriations Labor-Health and Human Services-Education Subcommittee Chair Robert Aderholt (R-Ala.) has decided to ban congressionally directed spending requests – or earmarks – from his panel’s FY 2024 appropriations bill. Many conservative members in the House of Representatives have expressed support for an across-the-board ban on earmarks in annual funding bills. Bans on earmark requests will also be applied to the Financial Services and Defense bills. House Appropriations Committee Chair Kay Granger (R-Texas) has indicated that Republicans will otherwise maintain the cap on earmarks at 15 per member, while also emphasizing that only those projects with a direct tie to the federal government will be considered for funding.

 

Senate Works to Advance Health Nominees

The Senate Finance Committee advanced President Joe Biden’s nomination of Rebecca Haffajee to serve as U.S. Department of Health and Human Services (HHS) Assistant Secretary for Planning and Evaluation (ASPE) last week over objections from panel Republicans in a 14-12 vote. Haffajee, an attorney and public health researcher, currently serves as ASPE’s principal deputy assistant secretary. Her nomination will now be sent to the full Senate for a vote. Senate Majority Leader Chuck Schumer (D-N.Y.) has also filed a procedural motion to limit debate and consider the nomination of Patrice Kunesh to serve as commissioner of the Administration for Native Americans at HHS.

 

Feinstein Hospitalized with Shingles

Sen. Dianne Feinstein (D-Calif.) has been hospitalized in San Francisco with a case of shingles after being diagnosed with the infection over the February recess. The Senate’s oldest member stated that she expects to make a full recovery and return to the chamber later this month. Feinstein adds to several health-related absences among Democrats in the Senate, who hold a narrow 51-49 seat majority, that could complicate the advancement of President Joe Biden’s judicial nominees. Feinstein is a member of the Senate Judiciary Committee, where Democrats hold a one-seat majority. Sen. John Fetterman (D-Pa.) remains in treatment for depression, and his office has not provided a timeframe for his return.

 

Rep. Castro Treated for Cancer

Rep. Joaquin Castro (D-Texas) will be absent from the House of Representatives for several weeks after undergoing surgery to remove cancerous tumors in his gastrointestinal tract. Castro stated that the “small, slow-growing, and mostly asymptomatic” gastrointestinal neuroendocrine tumors were discovered last summer following a series of tests, and that his overall prognosis is good. He plans to remain at home recovering for “several weeks” before returning to Washington.

 

Slotkin to Run for Senate

Rep. Elissa Slotkin (D-Mich.) announced last week that she will run to fill the seat of retiring Sen. Debbie Stabenow (D-Mich.) in 2024. Slotkin was first elected to the House of Representatives in 2018 after serving three tours in Iraq as an analyst for the Central Intelligence Agency. She currently serves on the House Armed Services and Agriculture committees.

 

FDA Panel Recommends Approval of RSV Vaccines

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted last week to recommend that the Food and Drug Administration (FDA) approve both Pfizer’s and GlaxoSmithKline’s (GSK) respiratory syncytial virus (RSV) vaccines. VRBPAC voted 7-4 with one abstention in support of the safety of Pfizer’s vaccine, and 7-4 with one abstention in support of the efficacy of Pfizer’s vaccine. Support for GSK’s product was wider – the panel voted 10-2 in support of its safety and were unanimous in support of its efficacy. Some panel members expressed concerns about the possibility of nervous system disorders like Guillain-Barré syndrome associated with the vaccines. If the vaccines are approved by the FDA, they will then be considered before the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for recommendations on how and when the vaccines are to be used.

 

New Survey Released on Telemedicine Use, Preferences

Most U.S. adults prefer getting prescription refills and care for minor illnesses via telemedicine rather than in-person care, according to a new survey released by Rock Health and Stanford University’s Center for Digital Health. The survey of more than 8,000 adults found that approximately two-thirds of Americans prefer in-person care for visits related to chronic conditions and mental health, while three-quarters of adults prefer in-person visits for annual wellness checks, emergency care, and physical therapy. The survey also covered the differences in rates of telemedicine use among different populations before and after the start of the coronavirus pandemic, finding telemedicine use grew especially among uninsured and rural respondents.

 

Upcoming Congressional Hearings and Markups

 

Senate Appropriations Subcommittee on Department of Defense meeting to receive a briefing on the Department of Defense Health Program; 10:00 a.m.; March 7

 

House Veterans Affairs Committee hearing “Veterans Health Information Systems and Technology Architecture (VistA);” 3:00 p.m.; March 7

 

House Intelligence Committee markup of H.R. 1376, COVID-19 Origins Act of 2023; 5:00 p.m.; March 7

 

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Investigating the Origins of COVID-19;” 9:00 a.m.; March 8

 

House Appropriations Subcommittee on Departments of Labor, Health and Human Services, Education, and Related Agencies Member Day Hearing; 10:00 a.m.; March 8

 

Senate Homeland Security & Governmental Affairs Committee hearing “Artificial Intelligence: Risks and Opportunities;” 10:00 a.m.; March 8

 

House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet hearing “Intellectual Property and Strategic Competition with China: Part I;” 10:00 a.m.; March 8

 

House Oversight and Accountability Subcommittee on Cybersecurity, Information Technology, and Government Innovation hearing “Advances in AI: Are We Ready for a Tech Revolution?” 2:00 p.m.; March 8

 

Senate Environment and Public Works Committee hearing to examine protecting public health and the environment in the wake of the Norfolk Southern train derailment and chemical release in East Palestine, Ohio; 10:00 a.m.; March 9

 

Senate Special Committee on Aging hearing “Uplifting Families, Workers, and Older Adults: Supporting Communities of Care;” 10:30 a.m.; March 9

 

Senate Health, Education, Labor, and Pensions Committee hearing “Taxpayers Paid Billions for It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.; March 22

 

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies public witness hearing; March 23

 

Recently Introduced Health Legislation

 

H.R.1191 – To amend title 38, United States Code, to expand eligibility for a presumption of service connection for diseases associated with exposure to certain herbicide agents for certain veterans who served in Guam; Sponsor: Moylan, James C. [Del.-R-GU-At Large]; Committees: House – Veterans’ Affairs

 

H.R.1182 – To amend the VA Choice and Quality Employment Act to direct the Secretary of Veterans Affairs to establish a vacancy and recruitment database to facilitate the recruitment of certain members of the Armed Forces to satisfy the occupational needs of the Department of Veterans Affairs, to establish and implement a training and certification program for intermediate care technicians in that Department, and for other purposes; Sponsor: González-Colón, Jenniffer [Resident Commissioner-R-PR-At Large]; Committees: House – Veterans’ Affairs

 

H.R.1173 – To amend the Federal Food, Drug, and Cosmetic Act regarding the patient medication information required to be included in the labeling of prescription drugs, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R- GA-1]; Committees: House – Energy and Commerce

 

H.R.1170 – To amend the Internal Revenue Code of 1986 to clarify that expenses for blood storage qualify as expenses for medical care; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House – Ways and Means

 

H.R.1166 – To enhance authorities under the Defense Production Act of 1950 to respond to the public health emergencies, to provide additional oversight of such authorities, and for other purposes; Sponsor: Vargas, Juan [Rep.-D- CA-52]; Committees: House – Financial Services

 

H.R.1154 – To combat forced organ harvesting and trafficking in persons for purposes of the removal of organs, and for other purposes; Sponsor: Smith, Christopher H. [Rep.-R-NJ-4]; Committees: House – Foreign Affairs; Judiciary

 

S.Res.85 – A resolution designating March 1, 2023, as “National Assistive Technology Awareness Day”. Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.84 – A resolution designating February 28, 2023, as “Rare Disease Day”. Sponsor: Brown, Sherrod [Sen.-D-OH]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.81 – A resolution relating to the establishment of a means for the Senate to provide advice and consent regarding the form of an international agreement relating to pandemic prevention, preparedness, and response. Sponsor: Risch, James E. [Sen.-R-ID]; Committees: Senate – Foreign Relations

 

S.Res.79 – A resolution expressing support for the designation of February 26, 2023, to March 4, 2023, as “National Fentanyl Awareness Week” and raising awareness of the negative impacts of fentanyl in the United States; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Judiciary

 

S.570 – A bill to amend title XIX of the Social Security Act to improve coverage of dental and oral health services for adults under Medicaid, and for other purposes. Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Finance

 

S.569 – A bill to amend title XXXIII of the Public Health Service Act with respect to flexibility and funding for the World Trade Center Health Program. Sponsor: Gillibrand, Kirsten E. [Sen.-D-NY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.565 – A bill to require the Secretary of Health and Human Services to award grants to pregnancy-help organizations. Sponsor: Risch, James E. [Sen.-R-ID]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.543 – A bill to increase research, education, and treatment for cerebral cavernous malformations. Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.186 – Expressing the sense of the House of Representatives that the People’s Republic of China should be held accountable for its handling of COVID-19. Sponsor: Mast, Brian J. [Rep.-R-FL-21]; Committees: House – Foreign Affairs

 

H.Res.185 – Declaring racism a public health crisis. Sponsor: Hayes, Jahana [Rep.-D-CT-5]; Committees: House – Energy and Commerce; Judiciary

 

H.Res.181 – Expressing support for the designation of February 28, 2023, as “Rare Disease Day”. Sponsor: Carson, Andre [Rep.-D-IN-7]; Committees: House – Energy and Commerce

 

H.Res.178 – Affirming the House of Representatives’ commitment to protect and strengthen Social Security and Medicare. Sponsor: Kildee, Daniel T. [Rep.-D-MI-8]; Committees: House – Ways and Means; Energy and Commerce

 

H.Res.175 – Recognizing the rise of cardiovascular disease as the world’s leading cause of preventable death and disability and as the global public health crisis of this generation and supporting the recognition of February 2023 as “American Heart Month”; Sponsor: Smith, Christopher H. [Rep.-R-NJ-4]; Committees: House – Energy and Commerce

 

H.Res.172 – Expressing support for designation of March 3, 2023, as “National Triple-Negative Breast Cancer Day”; Sponsor: Morelle, Joseph D. [Rep.-D-NY-25]; Committees: House – Oversight and Accountability

 

H.Res.170 – Recognizing it is the congressional intent of the Affordable Care Act that enhanced Federal medical assistance percentage funds are to be directly shared with the counties in States with a Medicaid local share requirement; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce

 

H.R.1199 – To amend title XVIII of the Social Security Act to ensure equitable payment for, and preserve Medicare beneficiary access to, diagnostic radiopharmaceuticals under the Medicare hospital outpatient prospective payment system; Sponsor: Dunn, Neal P. [Rep.-R-FL-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1201 – To amend title XIX of the Social Security Act to remove the exclusion from medical assistance under the Medicaid Program of items and services for patients in an institution for mental diseases, and for other purposes; Sponsor: Napolitano, Grace F. [Rep.-D-CA-31]; Committees: House – Energy and Commerce

 

H.R.1202 – To amend the Higher Education Act of 1965 to provide for interest-free deferment on student loans for borrowers serving in a medical or dental internship or residency program; Sponsor: Babin, Brian [Rep.-R-TX-36]; Committees: House – Education and the Workforce

 

H.R.1210 – To amend the Public Health Service Act to provide the Secretary of Health and Human Services with the authority to suspend the right to introduce certain persons or property into the United States in the interest of the public health; Sponsor: DesJarlais, Scott [Rep.-R-TN-4]; Committees: House – Energy and Commerce

 

H.R.1215 – To amend the Internal Revenue Code of 1986 to establish a refundable healthcare worker tax credit with semiannual advance payment; Sponsor: Magaziner, Seth [Rep.-D-RI-2]; Committees: House – Ways and Means

 

H.R.1224 – To amend the Public Health Service Act to provide for a national public awareness campaign to inform health care professionals and health care professional students on how to help patients navigate the legal landscape in the United States with respect to abortion and other reproductive health care services following the Supreme Court’s decision to overturn Roe v. Wade, and for other purposes; Sponsor: Trahan, Lori [Rep.-D-MA-3]; Committees: House – Energy and Commerce

 

H.R.1264 – To streamline the employer reporting process and strengthen the eligibility verification process for the premium assistance tax credit and cost-sharing subsidy. Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.1256 – To amend title 38, United States Code, to make certain improvements in the laws relating to the appointment of the Under Secretary of Health and Assistant Under Secretaries of Health of the Department of Veterans Affairs, and for other purposes. Sponsor: Mrvan, Frank J. [Rep.-D-IN-1]; Committees: House – Veterans’ Affairs

 

S.Res.90 – A resolution recognizing the significance of endometriosis as an unmet chronic disease for women and designating March 2023 as “Endometriosis Awareness Month”; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Judiciary

 

S.574 – A bill to amend the Federal Food, Drug, and Cosmetic Act to prevent the use of patents, trade secrets, or other intellectual property to inhibit competition; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.592 – A bill to amend title 38, United States Code, to increase the mileage rate offered by the Department of Veterans Affairs through their Beneficiary Travel program for health related travel, and for other purposes; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Veterans’ Affairs

 

S.600 – A bill to amend the Controlled Substance Act to list fentanyl-related substances as schedule I controlled substances; Sponsor: Johnson, Ron [Sen.-R-WI]; Committees: Senate – Judiciary

 

S.603 – A bill to establish procedures regarding the approval of opioid drugs by the Food and Drug Administration; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.604 – A bill to direct the Secretary of Health and Human Services to amend the mission statement of the Food and Drug Administration; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.606 – A bill to require the Food and Drug Administration to revoke the approval of one opioid pain medication for each new opioid medication approved; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.607 – A bill to allow the Secretary of Health and Human Services to deny approval of a new drug application for an opioid analgesic drug on the basis of such drug not being clinically superior to other commercially available drugs; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.614 – A bill to codify the temporary scheduling order for fentanyl-related substances by adding fentanyl-related substances to schedule I of the Controlled Substances Act; Sponsor: Cotton, Tom [Sen.-R-AR]; Committees: Senate – Judiciary

 

H.Res.193 – Expressing support for the goals and ideals of “World Hearing Day”; Sponsor: Thompson, Mike [Rep.-D- CA-4]; Committees: House – Energy and Commerce

 

H.R.1276 – To protect children from medical malpractice in the form of gender transition procedures; Sponsor: Banks, Jim [Rep.-R-IN-3]; Committees: House – Energy and Commerce; Judiciary; Education and the Workforce; Natural Resources; Ways and Means

 

H.R.1280 – To amend the Public Health Service Act to authorize the Secretary of Health and Human Services to carry out a program of research related to cerebral palsy, and for other purposes; Sponsor: Cohen, Steve [Rep.-D-TN-9]; Committees: House – Energy and Commerce

 

H.R.1291 – To amend the Controlled Substances Act to list fentanyl-related substances as schedule I controlled substances; Sponsor: Fitzgerald, Scott [Rep.-R-WI-5]; Committees: House – Energy and Commerce; Judiciary

 

H.R.1294 – To amend title XXXIII of the Public Health Service Act with respect to flexibility and funding for the World Trade Center Health Program; Sponsor: Garbarino, Andrew R. [Rep.-R-NY-2]; Committees: House – Energy and Commerce

 

H.R.1305 – To direct the Secretary of Health and Human Services, in consultation with the Secretary of State, to formulate a strategy for the Federal Government to secure support from foreign countries, multilateral organizations, and other appropriate entities to facilitate the development and commercialization of qualified pandemic or epidemic products, and for other purposes; Sponsor: Levin, Mike [Rep.-D-CA-49]; Committees: House – Foreign Affairs

 

H.R.1315 – To amend the Public Health Service Act to establish a Prostate Cancer Coordinating Committee, and for other purposes; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce

 

H.R.1316 – To amend titles XIX and XXI of the Social Security Act to allow States to provide for extended periods of continuous coverage under the Medicaid and CHIP programs for children, to provide a period of continuous eligibility under the Medicaid program for certain adults, and for other purposes; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Energy and Commerce

 

H.R.1326 – To modify the limitation on the deduction by individuals of certain State and local taxes and to provide coverage for hearing and vision care under the Medicare program; Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.1328 – To amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

S.624 – A bill to amend title X of the Public Health Service Act to prohibit family planning grants from being awarded to any entity that performs abortions, and for other purposes; Sponsor: Blackburn, Marsha [Sen.-R-TN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.626 – A bill to recommend that the Center for Medicare and Medicaid Innovation test the effect of a dementia care management model, and for other purposes; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

 

S.628 – A bill to amend the Internal Revenue Code of 1986 to provide for the treatment of direct primary care service arrangements as medical care, to provide that such arrangements do not disqualify deductible health savings account contributions, and for other purposes; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Finance

 

S.631 – A bill to protect the privacy of personally-identifiable health and location data, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Commerce, Science, and Transportation

 

S.635 – A bill to protect children from medical malpractice in the form of gender transition procedures; Sponsor: Cotton, Tom [Sen.-R-AR]; Committees: Senate – Judiciary

 

S.641 – A bill to terminate the requirement imposed by the Director of the Centers for Disease Control and Prevention for proof of COVID-19 vaccination for foreign travelers, and for other purposes; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.642 – A bill to facilitate the development of treatments for cancers, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Finance

 

S.644 – A bill to expand the take-home prescribing of methadone through pharmacies; Sponsor: Markey, Edward J. [Sen.- D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.652 – 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 an exceptions process for any medication step therapy protocol, and for other purposes; Sponsor: Murkowski, Lisa [Sen.-R-AK]; Committees: Senate – Health, Education, Labor, and Pensions

The Drug Enforcement Administration (DEA) has released a proposed rule to reinstate requirements that a patient see a doctor in-person before being prescribed certain controlled substances like Adderall and Oxycontin. These requirements had been waived for the duration of the COVID-19 pandemic. Providers would be permitted to prescribe an initial 30-day supply of buprenorphine for opioid use disorder, testosterone for gender affirming care, and ketamine for depression, but patients would then need to visit the provider in-person to continue their medications. Patients who began a covered medication during the pandemic would be given a 180-day grace period to comply with the in-person visit requirements. If finalized, the new regulation would go into effect when the COVID-19 public health emergency ends on May 11. The proposed rule will be open for public comment for 30 days.

 

GOP Health Leaders Request Transparency on Medicare Drug Negotiation Implementation

Republican health committee leaders have sent a letter to the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services regarding the $3 billion fund created by the Inflation Reduction Act for the implementation of new drug pricing measures. “We write to request information and regular updates on how the Biden administration plans to allocate, apply, and monitor this staggering sum moving forward,” the letter states. “By sidestepping regular order and bypassing the standard appropriations process, proponents of the IRA set aside billions in taxpayer dollars with no reporting requirements or tools to prevent waste, fraud, and abuse.” The lawmakers request updates on projected spending over the next decade so that Congress can appropriately adjust the IRA’s statutory spending level. The letter was signed by Senate Finance Committee Ranking Member Mike Crapo (R-Idaho), House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), and House Ways and Means Committee Chair Jason Smith (R-Mo.). They request a response from the administration by March 24.

 

Bilirakis, Tonko Launch Longevity Science Caucus

Reps. Gus Bilirakis (R-Fla.) and Paul Tonko (D-N.Y.) announced their formation of the Longevity Science Caucus last week. The group will work to promote aging technology and research in response to the decline in the nation’s life expectancy and to “support science and research that will enable people to live fuller and healthier lives.” Caucus membership includes Reps. Michael Burgess (R-Texas), Dan Crenshaw (R-Texas), and Anna Eshoo (D-Calif.), all members of the House Energy and Commerce Committee.

 

McClellan Sworn-In to House of Representatives; Lee and Cicilline Announce Future Plans

Rep. Jennifer McClellan (D-Va.) was sworn in as a member of the House of Representatives last week. She was elected to fill the only vacant seat in Congress. She succeeds the late Donald McEachin (D), who passed away in late November 2022. McClellan is an attorney and a 17-year state legislator. Her campaign for the House seat focused on expanding access to health care and protecting voting rights, the environment, and abortion services. She is the first Black woman to be elected to Congress from the state of Virginia.

Rep. Barbara Lee (D-Calif.) announced that she is joining the race to fill the Senate seat being vacated by Sen. Dianne Feinstein in 2024. Lee, a member of the House Appropriations and Budget committees, joins Reps. Katie Porter (D-Calif.) and Adam Schiff (D-Calif.) in running for Feinstein’s seat. Rep. David Cicilline (D-R.I.) announced that he will retire from the House of Representatives on June 1. Cicilline plans to become head of the Rhode Island Foundation. He currently serves as a member of the Judiciary Committee and Foreign Affairs Committee.

 

Warren Leads Letter on Keytruda Patents

Sen. Elizabeth Warren (D-Mass.) has sent a letter to the U.S. Patent and Trademark Office (USPTO) asking the agency to investigate Merck & Co.’s requests for new patents on its cancer treatment Keytruda. Merck is looking to patent a new self-injectable form of the drug. Warren expresses concerns that the company may be trying to use the patent system to prevent competition and urges USPTO Director Kathi Vidal to reject any requests that do not clearly meet the agency’s standards of novelty, utility, and non-obviousness. “Should the USPTO approve new patent applications for the drug, biosimilar competitors could be shut out of the market until 2036, giving Merck a total period of nearly 35 years of patent protection for Keytruda,” Warren argues. The letter was cosigned by Sen. Bernie Sanders (I-Vt.) and Reps. Katie Porter (D-Calif.) and Pramila Jayapal (D-Wash.).

 

Democrats Urge Administration to Address “Junk” Health Plans

Agroup of Senate Democrats have sent a letter to HHS Secretary Xavier Becerra asking the administration to take immediate action to address the availability of short-term, limited duration health insurance plans that violate the Affordable Care Act. The letter expresses concerns about individuals who will lose Medicaid coverage gained during the COVID-19 pandemic as state programs begin their redetermination processes. Without additional protections, “many Americans could find themselves enrolled in junk plans that do not provide comprehensive coverage or protection for individuals with pre-existing conditions,” the letter states. “It is past time for your department to step up and address the expansion and proliferation of junk plans.”

 

Wyden, Warren Request Info on McKinsey Hospital Guidance

Sens. Ron Wyden (D-Ore.) and Elizabeth Warren (D-Mass.) have sent a letter to McKinsey & Co. criticizing the consulting firm’s guidance to nonprofit hospitals, which they argue would take financial advantage of low-income patients. A recent report from the New York Times found that McKinsey was paid $45 million by non-profit hospital Providence Health to create a plan to use predatory tactics to pressure patients into paying for their care, no matter their income or ability to pay. “We write to seek a greater understanding of the full scope of McKinsey’s partnerships with nonprofit hospitals and the extent to which vulnerable patients may be exploited by them,” the lawmakers state.

 

POLICY BRIEFINGS

 

Upcoming Congressional Hearings and Markups

 
House Veterans’ Affairs Committee hearing “Building an Accountable VA: Applying Lessons Learned to Drive Future Success;” 2:00 p.m.; February 28

 

House Energy and Commerce Subcommittee on Innovation, Data, and Commerce hearing “Promoting U.S. Innovation and Individual Liberty through a National Standard for Data Privacy;” 8:30 a.m.; March 1

 

Senate Health, Education, Labor, and Pensions Committee hearing “Community Health Centers: Saving Lives, Saving Money;” 10:00 a.m.; March 2

 

House Veterans Affairs Committee hearing “Veterans Health Information Systems and Technology Architecture (VistA);” 3:00 p.m.; March 7

 

Senate Health, Education, Labor, and Pensions Committee hearing “Taxpayers Paid Billions for It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.; March 22

 

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies public witness hearing; March 23

 

Recently Introduced Health Legislation

 

H.R.1092 – To strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce

 

H.R.1090 – To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Energy and Commerce

 

H.R.1089 – To require directors of medical centers of the Department of Veterans Affairs to submit annual fact sheets to the Secretary of Veterans Affairs on the status of such facilities, and for other purposes; Sponsor: Lesko, Debbie [Rep.-R- AZ-8]; Committees: House – Veterans’ Affairs

 

H.R.1080 – To provide for the reinstatement or compensation of Federal employees forced to resign their careers between September 9, 2021, and January 24, 2022, because of the Federal COVID-19 vaccination mandate, and for other purposes; Sponsor: Gaetz, Matt [Rep.-R-FL-1]; Committees: House – Oversight and Accountability; Ways and Means

 

H.R.1079 – To amend title XIX of the Social Security Act to implement a minimum work requirement for able-bodied adults enrolled in State Medicaid programs; Sponsor: Gaetz, Matt [Rep.-R-FL-1]; Committees: House – Energy and Commerce

 

H.R.1074 – To amend title XIX of the Social Security Act to allow for greater State flexibility with respect to excluding providers who are involved in abortions; Sponsor: Cloud, Michael [Rep.-R-TX-27]; Committees: House – Energy and Commerce

 

H.R.1072 – To amend the Public Health Service Act to authorize supplemental awards to health centers to establish community transformation hubs; Sponsor: Clarke, Yvette D. [Rep.-D-NY-9]; Committees: House – Energy and Commerce

 

H.R.1066 – To require the Secretary of Health and Human Services to issue and disseminate guidance to States to clarify strategies to address social determinants of health under the Medicaid program and the Children’s Health Insurance Program, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.1110 – To direct the Secretary of Health and Human Services, the Medicare Payment Advisory Commission, and the Medicaid and CHIP Payment and Access Commission to conduct studies and report to Congress on actions taken to expand access to telehealth services under the Medicare, Medicaid, and Children’s Health Insurance programs during the COVID-19 emergency; Sponsor: Balderson, Troy [Rep.-R-OH-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1113 – To streamline enrollment in health insurance affordability programs and minimum essential coverage, and for other purposes; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1114 – To provide for optimized care, a coordinated Federal Government response, public education, and insurance reimbursement guidance for Long COVID, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.1117 – To implement certain recommendations to promote the inclusion of pregnant and lactating women in clinical research, and for other purposes; Sponsor: Castor, Kathy [Rep.-D-FL-14]; Committees: House – Energy and Commerce

 

H.R.1126 – To make improvements in prenatal and maternal care, and for other purposes; Sponsor: Fischbach, Michelle [Rep.-R-MN-7]; Committees: House – Energy and Commerce

 

H.R.1128 – To amend title XVIII of the Social Security Act to permit States to designate without any mileage limitations facilities that are located in rural areas as critical access hospitals; Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House – Ways and Means

 

H.R.1129 – To direct the Secretary of Health and Human Services to revise regulations to remove the requirement under the Medicare program that an off-campus facility or organization shall be located within a 35-mile radius of a hospital or critical access hospital; Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.1144 – To direct the Secretary of Veterans Affairs to develop a strategy for telehealth furnished by the Veterans Health Administration and submit a report on end-user devices distributed by the Secretary to veterans to facilitate such telehealth; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]; Committees: House – Veterans’ Affairs

Former President Jimmy Carter, 98, has begun receiving hospice care following a series of short hospital stays, according to The Carter Center. He has opted to forgo additional medical intervention in favor of spending his remaining time at home with his family, according to the statement from the center. Carter served as the 39th president of the United States from 1977 to 1981. He is the nation’s oldest living President and the nation’s longest-lived president.

 

Senate Appropriations Announces Subcommittee Rosters

Senate Appropriations Committee Chair Patty Murray (D-Wash.) and Ranking Member Susan Collins (R-Maine) have announced their panel’s subcommittee chairs, ranking members, and full rosters for the 118th Congress. Sen. Martin Heinrich (D-N.M.) and Sen. John Hoeven (R-N.D.) will serve as chair and ranking member of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee. Sen. Tammy Baldwin (D-Wis.) and Sen. Shelley Moore Capito (R-W.Va.) will serve as chair and ranking member of the Labor, Health and Human Services, Education, and Related Agencies Subcommittee. The full details on subcommittee leadership and rosters can be found here. Hart Health Strategies Inc. continues to update our Guide to the 118th Congress. This living document provides a list of health professionals serving in Congress, House and Senate leadership, congressional health committee members, and biographies on new members of Congress.

 

Coronavirus Panel Jumpstarts COVID-19 Origins Investigation

Republicans on the House Select Subcommittee on the Coronavirus Pandemic are requesting testimony, classified briefings, and documents from current Biden administration officials, U.S. intelligence agencies, and Anthony Fauci regarding the origins of the COVID-19 pandemic. The lawmakers are looking to further delve into theories that the coronavirus originated from laboratory experiments and gain-of-function research – possibly funded by U.S. dollars – in Wuhan, China, rather than from a Chinese market as much evidence indicates. Letters requesting information were sent to U.S. Department of Health and Human Services Secretary Xavier Becerra, former National Institute of Allergy and Infectious Diseases Director Anthony Fauci, EcoHealth Alliance President Peter Daszak, Director of National Intelligence Avril Haines, and White House adviser Francis Collins. Fauci has repeatedly stated that he would be willing to testify before any congressional committee if asked.

 

New GAO Report on Private Equity and IRB Effectiveness

The Government Accountability Office (GAO) released a new report last week regarding private equity consolidation of institutional review boards (IRBs). The report came at the request of Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie Sanders (I-Vt.) and Sens. Elizabeth Warren (D-Mass.) and Sherrod Brown (D-Ohio) due to concerns about the increased use of independent IRBs and the effect on protecting human subjects. The GAO makes four recommendations to improve federal oversight of IRBs, including that the U.S. Department of Health and Human Services and the Food and Drug Administration conduct annual risk assessments to determine if the agencies are routinely inspecting an adequate number of IRBs and to optimize the use of inspections in the oversight of IRBs and protection of research participants. GAO also suggests that agencies examine and implement approaches for measuring IRB effectiveness.

 

Feinstein Announces Retirement Decision

Sen. Dianne Feinstein (D-Calif.) announced her decision to not run for a seventh Senate term in 2024. Feinstein, 89, is the chamber’s longest serving Democrat and its oldest member. Her decision to retire was widely expected, with Reps. Katie Porter (D-Calif.) and Adam Schiff (D-Calif.) having previously announced bids for her seat in the Senate. Feinstein is currently a member of the Senate Judiciary Committee and the Appropriations Committee.

 

POLICY BRIEFINGS

Fetterman Seeks Treatment for Depression

Sen. John Fetterman (D-Pa.), 53, announced last week that he has checked himself into inpatient treatment at Walter Reed Medical Center and is seeking treatment for clinical depression on the recommendation of Congress’ attending physician. Fetterman is also in recovery from a stroke suffered on the campaign trail last year. According to the American Stroke Association, depression is common among stroke survivors. Fetterman’s aides have stated that he will likely return to the Senate from inpatient care in a few weeks.

 

Casey Undergoes Surgery for Prostate Cancer

Sen. Bob Casey (D-Pa.) underwent a scheduled surgery for prostate cancer last week and plans to return to the Senate “after a period of rest and recovery.” Doctors do not expect him to require further treatment, according to a tweet from the Senator’s office. While the chamber is not scheduled to reconvene until February 27, an extended absence from Casey, along with the absence of Sen. John Fetterman (D-Pa.), could have an impact on Senate business given Democrat’s slim 51-49 majority.

 

CBO Describes Scoring Methodology Behind Reconciliation Bill’s Drug Pricing Measures

The Congressional Budget Office (CBO) has released a presentation describing how the agency estimated the budgetary impact of the major prescription drug pricing provisions of the Inflation Reduction Act, passed last year via the budget reconciliation process. The law requires the U.S. Department of Health and Human Services to negotiate the prices of certain Medicare Part B and Part D drugs, requires pharmaceutical manufacturers of brand products to pay rebates if their prices exceed an inflation-adjusted benchmark, and provides for redesigns of the Part D benefit. In total, CBO estimated that these measures will reduce the federal deficit by $129 billion from 2022 through 2031.

 

Upcoming Congressional Hearings and Markups

Senate Health, Education, Labor, and Pensions Committee hearing “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.; March 22

 

House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies public witness hearing; March 23

 

Recently Introduced Health Legislation

H.R.982 – To address the health needs of incarcerated women related to pregnancy and childbirth, and for other purposes. Sponsor: Kamlager-Dove, Sydney [Rep.-D-CA-37]; Committees: House – Judiciary; Budget

 

H.R.977 – To repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals. Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.974 – To remove obstacles to the ability of law enforcement officers to enforce gun safety laws, and for other purposes. Sponsor: Beyer, Donald S., Jr. [Rep.-D-VA-8]; Committees: House – Judiciary

H.Res.122 – Expressing support for States to expand Medicaid under the Affordable Care Act to close the Medicaid coverage gap. Sponsor: Davis, Donald G. [Rep.-D-NC-1]; Committees: House – Energy and Commerce

 

S. 397 – A bill to provide for the publication by the Secretary of Health and Human Services of physical activity recommendations for Americans; Sponsor: Brown, Sherrod [D-OH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.403 – A bill to amend the Public Health Service Act to authorize a public education campaign across all relevant programs of the Health Resources and Services Administration to increase oral health literacy and awareness; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.406 – A bill to establish the Public Health Information and Communications Advisory Committee for purposes of providing recommendations and reports, and to support educational initiatives on communication and dissemination of information during public health emergencies; Sponsor: Murphy, Christopher [Sen.-D-CT]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.407 – A bill to amend title XIX of the Social Security Act to establish a methodology for determining State allotments for Medicaid disproportionate share hospital payments that is based on State poverty levels, to require States to prioritize disproportionate share hospital payments on the basis of Medicaid inpatient utilization and low-income utilization rates, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Finance

 

S.420 – A bill to prohibit Federal funds from being made available to facilities that refuse to provide treatment based on COVID-19 vaccination status; Sponsor: Paul, Rand [Sen.-R-KY]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.421 – A bill to prohibit Federal funding to the Wuhan Institute of Virology and to require a GAO study regarding Federal funds previously provided to such institute or to entities affiliated with the Chinese Government; Sponsor: Ernst, Joni [Sen.-R-IA]; Committees: Senate – Foreign Relations

 

S.423 – A bill to streamline enrollment in health insurance affordability programs and minimum essential coverage, and for other purposes; Sponsor: Van Hollen, Chris [Sen.-D-MD]; Committees: Senate – Finance

 

S.424 – A bill to protect the seniors of the United States, and for other purposes; Sponsor: Scott, Rick [Sen.-R-FL]; Latest Action: Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.

 

Recently Introduced Health Legislation -cntd

H.R.990 -To amend title XIX of the Social Security Act to establish a methodology for determining State allotments for Medicaid disproportionate share hospital payments that is based on State poverty levels, to require States to prioritize disproportionate share hospital payments on the basis of Medicaid inpatient utilization and low-income utilization rates, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce

 

H.R.991 – To prohibit Federal funds from being made available to entities that refuse to provide treatment based on COVID-19 vaccination status; Sponsor: Bishop, Dan [Rep.-R-NC-8]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.994 – To amend the Public Health Service Act to authorize a public education campaign across all relevant programs of the Health Resources and Services Administration to increase oral health literacy and awareness; Sponsor: Cárdenas, Tony [Rep.-D-CA-29]; Committees: House – Energy and Commerce

 

H.R.1001 – To amend the Higher Education Act of 1965 to include service as a veteran family caregiver as a public service job for purposes of the public service loan forgiveness program, and for other purposes; Sponsor: Connolly, Gerald E. [Rep.-D-VA-11]; Committees: House – Education and the Workforce

 

H.R.1003 -To direct the Secretary of Veterans Affairs to carry out a study and clinical trials on the effects of cannabis on certain health outcomes of veterans with chronic pain and post-traumatic stress disorder, and for other purposes; Sponsor: Correa, J. Luis [Rep.-D-CA-46]; Committees: House – Veterans’ Affairs

 

H.R.1004 – To establish the Public Health Information and Communications Advisory Committee for purposes of providing recommendations and reports, and to support educational initiatives on communication and dissemination of information during public health emergencies; Sponsor: DeGette, Diana [Rep.-D-CO-1]; Committees: House – Energy and Commerce

 

H.R.1011 -To require the Director of the Office of Management and Budget to conduct an audit of any unobligated coronavirus-related funding and to rescind all such funding, and for other purposes; Sponsor: Finstad, Brad [Rep.-RMN-1]; Committees: House – Oversight and Accountability; Appropriations

 

H.R.1012 -To amend the Public Health Service Act to clarify liability protections regarding emergency use of automated external defibrillators; Sponsor: Franklin, C. Scott [Rep.-R-FL-18]; Committees: House – Energy and Commerce

 

H.R.1024 – To amend the Public Health Service Act to ensure that nonanimal methods are prioritized, where applicable and feasible, in proposals for all research to be conducted or supported by the National Institutes of Health, to provide for the establishment of the National Center for Alternatives to Animals in Research and Testing, and for other purposes; Sponsor: Pappas, Chris [Rep.-D-NH-1]; Committees: House – Energy and Commerce

 

H.R.1025 – To prohibit Federal funding to the Wuhan Institute of Virology and to require a GAO study regarding Federal funds previously provided to such institute or to entities affiliated with the Chinese Government; Sponsor: Perry, Scott [Rep.-R-PA-10]; Committees: House – Foreign Affairs

 

H.R.1029 – To amend titles XVIII and XIX of the Social Security Act to make improvements to the treatment of the United States territories under the Medicare and Medicaid programs, and for other purposes; Sponsor: Plaskett, Stacey E. [Del.-D-VI-At Large]; Committees: House – Energy and Commerce; Ways and Means

 

S.444 – A bill to require any convention, agreement, or other international instrument on pandemic prevention, preparedness, and response reached by the World Health Assembly to be subject to Senate ratification; Sponsor: Johnson, Ron [Sen.-R-WI]; Committees: Senate – Foreign Relations

 

S.449 – A bill to amend title 38, United States Code, to improve the assignment of patient advocates at medical facilities of the Department of Veterans Affairs; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Veterans’ Affairs

 

S.455 – A bill to terminate the requirement imposed by the Director of the Centers for Disease Control and Prevention for proof of COVID-19 vaccination for foreign travelers, and for other purposes; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.456 – A bill to amend title 10, United States Code, to authorize non-medical counseling services, provided by certain mental health professionals, to military families; Sponsor: Sinema, Kyrsten [Sen.-I-AZ]; Committees: Senate – Armed Services

 

S.457 – A bill to establish a Federal tort against pediatric gender clinics and other entities pushing gender-transition procedures that cause bodily injury to children or harm the mental health of children; Sponsor: Hawley, Josh [Sen.-R-MO]; Committees: Senate – Judiciary

 

S.460 – A bill to amend the Indian Health Care Improvement Act to establish an urban Indian organization confer policy for the Department of Health and Human Services; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Indian Affairs

 

S.462 – A bill 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: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.464 – A bill to amend the Internal Revenue Code of 1986 to deny the deduction for advertising and promotional expenses for tobacco products and electronic nicotine delivery systems; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Finance

 

S.466 – A bill to provide for the National Academies of Sciences, Engineering, and Medicine to study and report on a Federal research agenda to advance the understanding of perfluoroalkyl and polyfluoroalkyl substances, and for other purposes; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Commerce, Science, and Transportation

 

S.468 – A bill to amend the Public Health Service Act to enhance compliance with hospital price transparency requirements, and for other purposes; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.470 – A bill to repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals, and for other purposes; Sponsor: Lankford, James [Sen.-R-OK]; Committees: Senate – Finance

 

S.471 – A bill to amend title XIX of the Social Security Act to allow for greater State flexibility with respect to excluding providers who are involved in abortions; Sponsor: Lankford, James [Sen.-R-OK]; Committees: Senate – Finance

 

S.476 – A bill to amend title XI of the Social Security Act to protect access to genetically targeted technologies; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Finance

 

S.492 – A bill to prohibit the imposition of certain substantial burdens, relating to COVID-19 vaccine mandates, on religious exercise, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Judiciary

 

S.526 – A bill to strengthen the use of patient-experience data within the benefit-risk framework for approval of new drugs; Sponsor: Wicker, Roger F. [Sen.-R-MS]; Committees: Senate – Health, Education, Labor, and Pensions

President Joe Biden delivered his State of the Union (SOTU) address on Tuesday; the speech highlighted his administration’s accomplishments on infrastructure, the climate, and consumer protections over the past two years. The President promised to not allow the nation to default on its debt, calling on Congress to pass a clean increase of the debt-ceiling and criticizing Republicans seeking to use debt-ceiling negotiations to force spending cuts. Biden’s speech also commended the work done by his administration to reach a point in which “COVID no longer controls our lives,” while acknowledging the need for Congress to fund ongoing efforts to support the development of new vaccines and treatments in response to emerging COVID-19 variants. Other health care priorities covered in the President’s address include:

Drug pricing: The President touted provisions contained in last year’s Inflation Reduction Act to cap out-of-pocket (OOP) drug costs for Medicare beneficiaries at $2,000 per year, allow drug price negotiations for the first time under the Medicare program, and to cap the OOP cost of insulin at $35 per month for Medicare beneficiaries. He also called for a universal $35 insulin price cap for all Americans.
Medicaid expansion: Biden called on the 11 states that have yet to expand their Medicaid programs to fill the coverage gap for the two million uninsured individuals who earn too much to qualify for Medicaid but too little to receive subsidies through their health insurance exchange.
Abortion: The President called on Congress to codify Roe v. Wade and stated that he would veto any national abortion ban passed by Congress.
Cancer Moonshot: Biden recommitted his support for the Cancer Moonshot initiative and called on Congress to do the same. The initiative aims to reduce the nation’s cancer death rate by 50% over the next 25 years.
Medicare: The President stated his plans to extend the Medicare Trust Fund by at least two decades and pledged to veto any attempts to cut the Medicare program.
The President’s full remarks, as prepared for delivery, can be found here. The Republican responses to the SOTU were delivered by Governor Sarah Huckabee Sanders (Ark.) and newly- elected Rep. Juan Ciscomani (Ariz.-06).

 

 

Senate Judiciary Advances Five Bipartisan Drug Pricing Bills

The Senate Judiciary Committee advanced five bipartisan bills aimed at reforming the drug patent system and increasing competition in the pharmaceutical marketplace. Each of the bills were reported favorably by voice vote. The following legislation was considered:

• S. 79, Interagency Patent Coordination and Improvement Act of 2023, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents.
• S. 113, Prescription Pricing for the People Act of 2023, to require the Federal Trade Commission (FTC) to study the role of intermediaries in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations.
• S. 142, Preserve Access to Affordable Generics and Biosimilars Act, to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products.
• S. 148, Stop STALLING Act, to enable the FTC to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns.
• S. 150, Affordable Prescriptions for Patients Act of 2023, to amend the Federal Trade Commission Act to prohibit product hopping. During consideration of this bill, Sen. Mazie Hirono (D-Hawaii) expressed concerns about potential unintended consequences, such as companies avoiding follow-on research out of fear of litigation. Sen. Mike Lee (R-Utah) also argued that the FTC already has the authority necessary to address such anticompetitive behavior.

 
While lawmakers appeared optimistic about the bills’ chances of passing the Senate, it remains unclear whether they would be taken up by the Republican-controlled House of Representatives.
 

Finance, HELP Leadership Consider Common Ground for 118th Congress

With congressional committees convening for their first organizational meetings of the 118th Congress in recent weeks, panel leadership have begun to shed light on their agendas for the next two years. In the Senate Finance Committee, Ranking Member Mike Crapo (R-Idaho) outlined health care priorities that largely align with those of Chair Ron Wyden (D-Ore.). While Crapo has highlighted the need for oversight of the Biden administration’s implementation of the Inflation Reduction Act’s drug pricing provisions, both leaders are aiming to target rising health care costs, health care workforce shortages, and access to telehealth during the 118th Congress. Sen. Ben Cardin (D-Md.) will serve as the new chair of the Senate Finance Health Care Subcommittee, replacing Sen. Debbie Stabenow (D-Mich.) who will remain a member of the subcommittee. Sen. Steve Daines (R-Mont.) will continue to serve as the subcommittee’s ranking member. Cardin has said that he will focus on behavioral health and care for those with substance use disorders, expanding Medicaid and Medicare coverage for dental health, and maintaining telehealth access as subcommittee chair. Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie Sanders (I-Vt.) and Ranking Member Bill Cassidy (R-La.) also previewed their common ground priorities during the panel’s first meeting of the 118th Congress last week. These focus areas include the opioid crisis, oral health care, mental health care, and prescription drug costs, with Ranking Member Cassidy specifically acknowledging the need to balance concerns around affordability and medical innovation in drug pricing.

 

HHS Prepares States, Stakeholders For End of PHE

U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra set a letter to governors last week discussing his decision to renew the COVID-19 public health emergency (PHE) for the final time, effective February 11, and to terminate the PHE on May 11. HHS also released a fact sheet providing a transition roadmap describing the impact of the PHE expiration. Those PHE-linked flexibilities and policies that will be affected by the end of the emergency declaration include:

Medicare beneficiaries who are enrolled in Part B will continue to have coverage without cost sharing for laboratory- conducted COVID-19 tests when ordered by a provider, but their current access to free over the counter (OTC) COVID-19 tests will end.
The requirement for private insurance companies to cover COVID-19 tests without cost sharing, both for OTC and laboratory tests, will end.
State Medicaid programs must provide coverage without cost sharing for COVID-19 testing until the last day of the first calendar quarter that begins one year after the last day of the COVID-19 PHE. That means that mandatory coverage will end on September 30, 2024.
Reporting of COVID-19 laboratory results and immunization data to CDC will change. HHS will no longer have the express authority to require lab test reporting for COVID-19. Hospital data reporting will continue as required by the Centers for Medicare and Medicaid Services conditions of participation through April 30, 2024, but reporting may be reduced from the current daily reporting to a lesser frequency.
Certain Food and Drug Administration COVID-19-related guidance documents for industry that affect clinical practice and supply chains will end or be temporarily extended. FDA is in the process of addressing which policies are no longer needed and which should be continued, and the agency will announce plans for each guidance prior to the end of the PHE.
During the PHE, manufacturers of certain devices related to the diagnosis and treatment of COVID-19 have been required to notify the FDA “of a permanent discontinuance in the manufacture of the device” or “an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States.” This requirement will end when the PHE ends.
Public Readiness and Emergency Preparedness (PREP) Act liability protections for countermeasure activities that are not related to any USG agreement (e.g., products entirely in the commercial sector or solely a state or local activity) will end unless another federal, state, or local emergency declaration is in place for the area where countermeasures are administered.
The ability of health care providers to safely dispense controlled substances via telemedicine without an in-person interaction is affected; however, there will be rulemaking that will propose to extend these flexibilities.
The Department will host a briefing on Monday, February 13 at 3:00 p.m. ET to discuss the end of the PHE. Registration information is available here.

 

BCBSA Proposes Policies to Reduce Health Care Costs

The Blue Cross Blue Shield Association (BCBSA) released a proposed plan last week to lower health care costs which it estimates would reduce federal deficits by $337 billion over the next decade and reduce overall national health expenditures by $767 billion. Their proposal focuses on lowering the prices paid for health care in Medicare and the commercial insurance market through six policies: adopting site-neutral payment policies in Medicare, expanding antitrust funding and enforcement, prohibiting anti-competitive provisions in provider contracts, facilitating generic drug and biosimilar entry, limiting the exclusivity period for biologicals, and repealing the tax deduction for drug advertising. BCBSA also proposes two additional policies which it argues will protect against increases in health care costs: preserving the ability of health insurers to use step therapy and pharmacy networks and to continue allowing health insurers to utilize prior authorization.

 

Upcoming Congressional Hearings and Markups

House Energy and Commerce Subcommittee on Oversight and Investigations and Subcommittee on Health field hearing “President Biden’s Border Crisis is a Public Health Crisis;” 6:00 p.m.; February 15

Senate Health, Education, Labor, and Pensions Committee hearing “Examining Health Care Workforce Shortages: Where Do We Go From Here?” 10:00 a.m.; February 16

Senate Committee on Commerce, Science, and Transportation hearing to examine bringing transparency and accountability to pharmacy benefit managers; 10:00 a.m.; February 16

 

POLICY BRIEFINGS

Recently Introduced Health Legislation

H.R.830 – 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: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.831 – To amend title XVIII of the Social Security Act to provide for coverage under part B of the Medicare program for medically necessary dental procedures; Sponsor: Cohen, Steve [Rep.-D-TN-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.833 – To amend titles XVIII and XIX of the Social Security Act to provide for enhanced payments to rural health care providers under the Medicare and Medicaid programs, and for other purposes; Sponsor: Graves, Sam [Rep.-R-MO-6]; Committees: House – Energy and Commerce; Ways and Means; Budget

 

H.R.834 – To amend title XVIII of the Social Security Act to support rural residency training funding that is equitable for all States, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.849 – To require the Department of Defense to share best practices with, and offers training to, State and local first responders regarding how to most effectively aid victims who experience trauma-related injuries; Sponsor: Torres, Ritchie [Rep.-D-NY-15]; Committees: House – Armed Services

 

H.R.853 – To amend titles II and XVIII of the Social Security Act to establish a Social Security Surplus Protection Account in the Federal Old-Age and Survivors Insurance Trust Fund to hold the Social Security surplus and a Medicare Surplus Protection Account in the Federal Hospital Insurance Trust Fund to hold the Medicare surplus, to provide for suspension of investment of amounts held in such Accounts until enactment of legislation providing for investment of the Trust Funds in investment vehicles other than obligations of the United States, and to establish a Social Security and Medicare Part A Investment Commission to make recommendations for alternative forms of investment of the Social Security and Medicare surpluses; Sponsor: Walberg, Tim [Rep.-R-MI-5]; Committees: House – Ways and Means

 

S.J.Res.10 – A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Veterans Affairs relating to “Reproductive Health Services”; Sponsor: Tuberville, Tommy [Sen.-R-AL]; Committees: Senate – Veterans’ Affairs

 

S.280 – A bill to ensure that only licensed health care professionals furnish disability examinations under a certain Department of Veterans Affairs pilot program for use of contract physicians for disability examinations, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Veterans’ Affairs

 

S.288 – A bill to prevent, treat, and cure tuberculosis globally; Sponsor: Menendez, Robert [Sen.-D-NJ]; Committees: Senate – Foreign Relations

 

S.289 – A bill to improve national security at the National Institutes of Health, to address national security issues in the licensure of biological products, to address national security considerations in research at the Department of Health and Human Services, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.302 – A bill to amend title 10, United States Code, to direct the Secretary of Defense to provide colorectal cancer screening for members of the uniformed services who served in locations associated with toxic exposure, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Armed Services

 

H.Res.99 – Supporting the goals and ideals of “National Black HIV/AIDS Awareness Day”; Sponsor: Lee, Barbara [Rep.- D-CA-12]; Committees: House – Energy and Commerce H.J.Res.31 – Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Department of Veterans Affairs relating to “Reproductive Health Services”; Sponsor: Cloud, Michael [Rep.-R- TX-27]; Committees: House – Veterans’ Affairs

 

H.R.875 – To authorize the Secretary of the Treasury to issue obligations to make Medicare and Social Security payments, despite the debt limit being reached; Sponsor: James, John [Rep.-R-MI-10]; Committees: House – Ways and Means

 

H.R.880 – To establish a program to provide for women’s heart health continuing medical education, and for other purposes; Sponsor: Sherrill, Mikie [Rep.-D-NJ-11]; Committees: House – Energy and Commerce

 

S.312 – A bill to amend title XVIII of the Social Security Act to modernize payments for ambulatory surgical centers under the Medicare program, and for other purposes; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Finance

 

S.315 – A bill to direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.323 – A bill to ensure the privacy of pregnancy termination or loss information under the HIPAA privacy regulations and the HITECH Act; Sponsor: Hirono, Mazie K. [Sen.-D-HI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.324 – A bill to authorize the Secretary of Health and Human Services to carry out activities relating to neglected diseases of poverty; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.326 – A bill to direct the Secretary of Veterans Affairs to carry out a study and clinical trials on the effects of cannabis on certain health outcomes of veterans with chronic pain and post-traumatic stress disorder, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate – Veterans’ Affairs

 

H.Res.118 – Maintaining Medicare; Sponsor: Van Duyne, Beth [Rep.-R-TX-24]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.885 – To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Energy and Commerce; Armed Services; Veterans’ Affairs; Judiciary; Ways and Means; Science, Space, and Technology

 

H.R.894 – To amend title 38, United States Code, to provide for limitations on copayments for contraception furnished by the Department of Veterans Affairs, and for other purposes; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Committees: House – Veterans’ Affairs

 

H.R.896 – To ensure that patients receive accurate health care information by prohibiting misleading and deceptive advertising or representation in the provision of health care services, to require the identification of the license of health care professionals, and for other purposes; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Energy and Commerce

 

H.R.901 – To require the Food and Drug Administration to prioritize enforcement of disposable electronic nicotine delivery system products; Sponsor: Cherfilus-McCormick, Sheila [Rep.-D-FL-20]; Committees: House – Energy and Commerce

 

H.R.902 – To provide for further comprehensive research at the National Institute of Neurological Disorders and Stroke on unruptured intracranial aneurysms; Sponsor: Clarke, Yvette D. [Rep.-D-NY-9]; Committees: House – Energy and Commerce

 

H.R.949 – To amend title XI of the Social Security Act to eliminate the general Medicaid funding limitations for territories of the United States, and for other purposes; Sponsor: Sablan, Gregorio Kilili Camacho [Del.-D-MP-At Large]; Committees: House – Energy and Commerce

 

H.R.952 – To amend title XIX of the Social Security Act to renew the application of the Medicare payment rate floor to primary care services furnished under the Medicaid program, and for other purposes; Sponsor: Schrier, Kim [Rep.-D- WA-8]; Committees: House – Energy and Commerce

 

H.R.955 – To amend title XVIII of the Social Security Act to allow payments under the Medicare program for certain items and services furnished by off-campus outpatient departments of a provider to be determined under the prospective payment system for hospital outpatient department services, and for other purposes; Sponsor: Smith, Adrian [Rep.-R- NE-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.960 – To amend title XVIII of the Social Security Act to prohibit the use of an inpatient-only list in designating hospital outpatient services under the Medicare program; Sponsor: Steube, W. Gregory [Rep.-R-FL-17]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.972 – To amend title XVIII of the Social Security Act to modernize payments for ambulatory surgical centers under the Medicare program, and for other purposes; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Energy and Commerce; Ways and Means

The Biden administration announced plans last week to end the COVID-19 emergency declarations on May 11. The decision applies to both the national emergency and public health emergency (PHE) in response to COVID-19 that have remained in place for over three years since they were first declared. The end of the emergency declarations 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 be responsible for paying for vaccines, tests, and treatments out-of-pocket, while insured individuals may see the cost of such products increase. Vaccines will remain free for Medicare, Medicaid, and Children’s Health Insurance Program beneficiaries. Other flexibilities and regulatory authorities instituted in response to the COVID-19 PHE would also end, though some measures have already been de-linked from the emergency declaration. The Consolidated Appropriations Act, 2023, for example, extends certain telehealth policies through 2024 and permits states to resume Medicaid redeterminations in April. Other provisions, such as the Medicare coverage requirement waivers (like the three-day hospital stay requirement prior to a skilled nursing facility admission) and permission for patients to get extended supplies of many drugs under the Medicare prescription drug benefit, were not extended in the year-end funding bill. Hospitals will also no longer receive the 20% increased Medicare payment for the treatment of COVID-19 patients. According to a senior administration official, the transition period over the next three months will allow the White House to “begin the process of a smooth operational wind-down of the flexibilities enabled by the COVID-19 emergency declarations.” The announcement was made within a series of White House statements in opposition to several bills passed by the House of Representatives warning that ending the PHE too soon would have “highly significant impacts on our nation’s health system and government operations.” The bills passed the House include:
H.R. 497 – Freedom for Health Care Workers Act, to block the federal COVID-19 vaccine mandate for health care workers under the Medicare and Medicaid programs;
H.R. 382 – Pandemic is Over Act, to end the COVID-19 PHE;
H.R. 139 – SHOW UP Act of 2023, to end COVID-era telework policies for federal workers; and
H.J. Res. 7, to terminate the national emergency declared on March 13, 2020.
This week, the House plans to vote on legislation (H.R. 185) that would end the COVID-19 vaccine mandate for international travelers entering the U.S. Proponents of the bill argue that the requirement should be dropped given the ending of the COVID-19 emergency declarations on May 11.

 

President’s FY24 Budget to Be Released March 9

The White House plans to release President Joe Biden’s fiscal year (FY) 2024 budget on Thursday, March 9. According to Brian Deese, National Economic Council Director, and Shalanda Young, Office of Management and Budget Director, the budget will “show how the President plans to invest in America, continue to lower costs for families, protect and strengthen Social Security and Medicare, and reduce the deficit.” They called on Republicans to release their own budget containing proposals for reducing the deficit. Majority Leader Steve Scalise (R-La.) confirmed the House GOP’s plan to release their proposed budget by April. Republicans have stated their intent to balance the federal budget within the next decade.

 

Wyden Requests Details on IRA’s Drug Rebate Provisions

Senate Finance Committee Chair Ron Wyden (D-Ore.) has sent a letter to the Centers for Medicare and Medicaid Services (CMS) requesting information on how the agency plans to collect the Medicare Part B and Part D inflation rebates created as a part of the drug pricing provisions in last year’s Inflation Reduction Act. The law requires manufacturers to pay a rebate to Medicare when they increase their drug prices faster than the rate of inflation, with Medicare penalizing manufacturers for price increases that outpace inflation starting in October 2022 for Part D drugs and in January 2023 for Part B drugs. Wyden asks for an explanation of how rebates will be calculated and a timeline for their implementation.

 

Senators Criticize Lack of FDA Vaping Regulation Enforcement

Abipartisan group of 13 senators has sent a letter to the U.S. Department of Health and Human Services criticizing the “repeated failures” of the Food and Drug Administration (FDA) to regulate the tobacco and e-cigarette market and to take action against companies marketing illegal vaping products. The agency recently estimated that it will not finish reviewing marketing applications from e-cigarette manufacturers until the end of December, six months later than previously projected. The FDA already stands 16 months past a court-ordered deadline to complete review of e-cigarette marketing applications. The lawmakers argue that as many as one million children will be at risk of starting e-cigarette use because of this delay. Their letter follows a report from the Reagan-Udall Foundation which found that the absence of “timely enforcement action jeopardizes public health and undermines creditability and effectiveness in tobacco product regulation.”

 

Legislators Urge Elevation of ONDCP

Abipartisan, bicameral group of 55 legislators is urging President Joe Biden to reinstate the Director of the Office of National Drug Control Policy (ONDCP) to a cabinet-level position amid rising rates of drug overdoses across the United States. They request that the President announce the change during this week’s State of the Union address, arguing that re-elevating “ONDCP to the Cabinet will allow it to marshal the full resources of the federal government against this scourge of overdoses and demonstrate to the Congress and the American people [his] commitment to ending it.” Overdoses currently represent the leading cause of death for Americans aged 18 to 45.

 

Lawmakers Request More Funding for KidneyX

Abipartisan, bicameral group of lawmakers is asking the Biden administration to increase funding for kidney care in the President’s fiscal year 2024 budget. The lawmakers request a $25 million investment in KidneyX – a partnership between the U.S. Department of Health and Human Services and the American Society of Nephrology that aims to encourage innovation in the prevention, diagnosis, and treatment of kidney diseases. “With more funding, KidneyX could expand the number of innovators it supports and accelerate the development of transformative technologies, particularly the artificial kidney,” the letter states. The lawmakers argue this investment could ultimately reduce the amount of money the nation spends on kidney care and the treatment of kidney failure. The letter was signed by Sens. Ben Cardin (D-Md.) and Todd Young (R-Ind.), and Reps. Suzan DelBene (D-Wash.) and Larry Bucshon (R-Ind.).

 

Democrats Ask Manufacturer to Revise Mifepristone Label

Agroup of Senate Democrats led by Sens. Mazie K. Hirono (D-Hawaii), Maggie Hassan (D-N.H.), and Elizabeth Warren (D-Mass.) is urging Danco Laboratories to add a miscarriage management indication to the drug label for Mifeprex (mifepristone). The lawmakers argue that because miscarriage is not currently included on the approved label, health care providers lack clear legal guidance on the product’s use and “patients experiencing early pregnancy loss who need mifepristone cannot easily access this critical treatment, placing them at risk of serious injury and death.” The Food and Drug Administration recently rejected a citizen petition filed by the American College of Obstetricians and Gynecologists, along with 48 other organizations, for such a label change on the grounds that only the manufacturer of the drug has the authority to request this type of change.

 

GAO Releases Report on Nation’s Ability to Investigate Pandemic Origins

The Government Accountability Office (GAO) released a new report last week examining the United States’ lack of a national strategy for investigating the origins of disease outbreaks and pandemics. The report details the technologies available for researchers to investigate a pandemic’s origin – such as genomic sequencing, bioinformatics analysis, genetic databases, serology, and epidemiological surveillance – and their limitations. Experts told the GAO, however, that such technologies are not the limiting factor for determining the likely origin of a pandemic. The agency identified three cross- cutting challenges facing disease origin investigations: a lack of sufficient access to samples and genetic sequence data; a lack of standardized processes for submitting, accessing, and using genetic sequence data; and a lack of a sufficient and skilled interdisciplinary workforce. The report also outlines five policy options to address these challenges:
Establish multilateral agreements for accessing and sharing samples and genetic sequence data;
Develop standardized processes for genetic sequence database use;
Improve current, or develop new, genetic sequence database tools;
Encourage the development, retention, and growth of a workforce with the critical skills needed for pandemic origin investigations; and
Augment or develop a national strategy to better coordinate and collaborate domestically and internationally on pandemic origin investigations.
A GAO representative testified before the House Energy and Commerce Oversight and Investigations Subcommittee during the panel’s first hearing of the 118th Congress, titled “Challenges and Opportunities to Investigating the Origins of Pandemics and Other Biological Events” last week. Republican leadership of the full committee have also revived their investigative work into the origins of COVID-19, sending letters to the National Institutes of Health and EcoHealth Alliance requesting documents related to research done at the Wuhan Institute of Virology.

 

POLICY BRIEFINGS

 

Upcoming Congressional Hearings and Markups

House Energy and Commerce Joint Subcommittee on Oversight and Investigations and Subcommittee on Health hearing “The Federal Response to COVID-19;” 10:00 a.m.; February 8
Senate Judiciary Committee Executive Business Meeting to consider nominations and markup the following bills: S. 79, Interagency Patent Coordination and Improvement Act; S. 113, Prescription Pricing for the People Act; S. 142, Preserve Access to Affordable Generics and Biosimilars Act; S. 148, Stop STALLING Act; and S. 150, Affordable Prescriptions for Patients Act; 9:00 a.m.; February 9
 

Recently Introduced Health Legislation

S.131 – A bill to amend chapter 81 of title 5, United States Code, to cover, for purposes of workers” compensation under such chapter, services by physician assistants and nurse practitioners provided to injured Federal workers, and for other purposes; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Homeland Security and Governmental Affairs
 
S.132 – A bill 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: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Veterans” Affairs
 
S.133 – A bill to extend the National Alzheimer”s Project; Sponsor: Collins, Susan M. [Sen.-R-ME]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.134 – A bill to require an annual budget estimate for the initiatives of the National Institutes of Health pursuant to reports and recommendations made under the National Alzheimer”s Project Act; Sponsor: Collins, Susan M. [Sen.-R-ME]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.141 – A bill to amend title 38, United States Code, to improve certain programs of the Department of Veterans Affairs for home and community based services for veterans, and for other purposes; Sponsor: Moran, Jerry [Sen.-R-KS]; Committees: Senate – Veterans” Affairs
 
S.142 – A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Judiciary
 
S.146 – A bill to reduce the price of insulin for patients; Sponsor: Hawley, Josh [Sen.-R-MO]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.148 – A bill to enable to Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Judiciary
 
S.150 – A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Judiciary
 
H.Res.73 – Expressing the sense of the House of Representatives that Medicare and Social Security provide an essential benefit for current enrollees and should be strengthened for future generations; Sponsor: Lesko, Debbie [Rep.-R-AZ-8]; Committees: House – Ways and Means; Energy and Commerce
 
H.R.618 – To amend chapter 81 of title 5, United States Code, to cover, for purposes of workers” compensation under such chapter, services by physician assistants and nurse practitioners provided to injured Federal workers, and for other purposes; Sponsor: Walberg, Tim [Rep.-R-MI-5]; Committees: House – Education and the Workforce
 
H.R.619 – To extend the National Alzheimer”s Project; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce
 
H.R.620 – To require an annual budget estimate for the initiatives of the National Institutes of Health pursuant to reports and recommendations made under the National Alzheimer”s Project Act; Sponsor: Smith, Christopher H. [Rep.-R-NJ-4]; Committees: House – Energy and Commerce
 
H.R.629 – To amend title XI of the Social Security Act to provide for State approval and implementation of specified waivers under the Medicaid program; Sponsor: Green, Mark E. [Rep.-R-TN-7]; Committees: House – Energy and Commerce
 
H.R.630 – To amend the Indian Health Care Improvement Act to establish an urban Indian organization confer policy for the Department of Health and Human Services; Sponsor: Grijalva, Raúl M. [Rep.-D-AZ-7]; Committees: House – Natural Resources; Energy and Commerce
 
H.R.632 – To amend title XIX of the Social Security Act and Public Health Service Act to improve the reporting of abortion data to the Centers for Disease Control and Prevention, and for other purposes; Sponsor: Norman, Ralph [Rep.- R-SC-5]; Committees: House – Energy and Commerce
 
H.R.633 – To amend title XXVII of the Public Health Service Act to exempt certain direct primary care arrangements from regulation as health insurance coverage; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]; Committees: House – Energy and Commerce
 
H.R.635 – To amend title XVIII of the Social Security Act to permanently include certain HCPCS codes as telehealth services under such title, and for other purposes; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]; Committees: House – Energy and Commerce; Ways and Means
 
S.164 – A bill to prohibit the consideration of COVID-19 vaccination status in determining eligibility for organ donation or transplantation, and in providing services to Medicare or Medicaid beneficiaries; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.166 – A bill to amend the Family and Medical Leave Act of 1993 to provide leave for the spontaneous loss of an unborn child, and for other purposes; Sponsor: Cotton, Tom [Sen.-R-AR]; Committees: Senate – Finance
 
S.167 – A bill to prohibit vaccination mandates for COVID-19; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Judiciary
 
S.169 – A bill to prohibit certain COVID-19 vaccination mandates for minors, and to require parental consent for COVID-19 vaccination of minors; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.171 – A bill to prohibit the consideration of patients” race, color, religion, sex, national origin, age, disability, vaccination status, veteran status, or political ideology or speech in determining eligibility for COVID-19 treatments and vaccines distributed by the Federal Government; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.172 – A bill to terminate any existing mask mandates imposed by the Federal Government, to prevent the implementation of new mask mandates, to preserve individual liberty, and for other purposes; Sponsor: Cruz, Ted [Sen.-R- TX]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.181 – A bill to protect individual liberty, ensure privacy, and prohibit discrimination with respect to the vaccination status of individuals, and for other purposes; Sponsor: Cruz, Ted [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions
 
H.R.670 – To amend title IV of the Public Health Service Act to direct the Secretary of Health and Human Services to establish a clearinghouse on intellectual disabilities, and for other purposes; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce
 
H.R.677 – To amend the Internal Revenue Code of 1986 to make improvements to Health Savings Accounts; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]; Committees: House – Ways and Means
 
S.198 – A bill to amend title XVIII of the Social Security Act to modernize provisions relating to rural health clinics under Medicare; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance
 
S.204 – A bill to amend title 18, United States Code, to prohibit a health care practitioner from failing to exercise the proper degree of care in the case of a child who survives an abortion or attempted abortion; Sponsor: Thune, John [Sen.-R- SD]; Committees: Senate – Judiciary
 
S.205 – A bill to promote minimum State requirements for the prevention and treatment of concussions caused by participation in school sports, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.208 – A bill to establish a procedure for terminating a determination by Surgeon General to suspend certain entries and imports from designated places; Sponsor: Lankford, James [Sen.-R-OK]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.213 – A bill to authorize the Secretary of the Treasury to issue obligations to make Medicare and Social Security payments, despite the debt limit being reached; Sponsor: Hawley, Josh [Sen.-R-MO]; Committees: Senate – Finance
 
S.216 – A bill 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: Moran, Jerry [Sen.-R-KS]; Committees: Senate – Veterans” Affairs
 
H.R.704 – To amend title XVIII of the Social Security Act to permit nurse practitioners and physician assistants to satisfy the documentation requirement under the Medicare program for coverage of certain shoes for individuals with diabetes; Sponsor: Blumenauer, Earl [Rep.-D-OR-3]; Committees: House – Energy and Commerce; Ways and Means
 
H.R.706 – To amend the Food and Nutrition Act of 2008 to allow households with children with chronic medical conditions to deduct allowable medical expenses incurred by such household member that exceeds $35 per month; Sponsor: Brown, Shontel M. [Rep.-D-OH-11]; Committees: House – Agriculture
 
H.R.711 – To amend title XXVII of the Public Health Service Act to eliminate the short-term limited duration insurance exemption with respect to individual health insurance coverage; Sponsor: Castor, Kathy [Rep.-D-FL-14]; Committees: House – Energy and Commerce
 
H.R.732 – To rename the program under part C of title XVIII of the Social Security Act, and for other purposes; Sponsor: Pocan, Mark [Rep.-D-WI-2]; Committees: House – Ways and Means; Energy and Commerce
 
Recently Introduced Health Legislation Contd.
 
H.R.733 – To direct the Secretary of Veterans Affairs to improve mental health care for veterans through the establishment of a minimum requirement for the number of Vet Centers per State; Sponsor: Sherrill, Mikie [Rep.-D-NJ-11]; Committees: House – Veterans’ Affairs
 
S.230 – A bill to amend title XVIII of the Social Security Act to support rural residency training funding that is equitable for all States, and for other purposes; Sponsor: Tester, Jon [Sen.-D-MT]; Committees: Senate ” Finance
 
S.237 – A bill to preserve access to abortion medications; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.242 – A bill to amend the Family and Medical Leave Act of 1993 and title 5, United States Code, to permit leave to care for a domestic partner, parent-in-law, or adult child, or another related individual, who has a serious health condition, and to allow employees to take, as additional leave, parental involvement and family wellness leave to participate in or attend their children’s and grandchildren’s educational and extracurricular activities or meet family care needs; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions
 
S.260 – A bill to amend title XVIII of the Social Security Act to permit nurse practitioners and physician assistants to satisfy the documentation requirement under the Medicare program for coverage of certain shoes for individuals with diabetes; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Finance
 
S.265 – A bill to reauthorize the rural emergency medical service training and equipment assistance program, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions
 
H.Res.93 – Expressing support for the designation of February 4, 2023, as “National Cancer Prevention Day”; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce
 
H.R.746 – To amend title 38, United States Code, to expand certain rehabilitation programs for certain veterans with service-connected disabilities; Sponsor: Obernolte, Jay [Rep.-R-CA-23]; Committees: House – Veterans’ Affairs
 
H.R.751 – To amend title XVIII of the Social Security Act to require as a condition of satisfying the definition of an approved medical residency training program for purposes of payments under Medicare for costs related to graduate medical education for hospitals operating such a program to submit information to encourage more equitable treatment of osteopathic and allopathic candidates in the residency application and review process, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Ways and Means; Energy and Commerce
 
H.R.753 – To direct the Secretary of Veterans Affairs to use on-site regulated medical waste treatment systems at certain Department of Veterans Affairs facilities, and for other purposes; Sponsor: Bost, Mike [Rep.-R-IL-12]; Committees: House – Veterans’ Affairs
 
H.R.754 – To establish an advisory commission regarding eligibility for health care furnished by the Secretary of Veterans Affairs; Sponsor: Bost, Mike [Rep.-R-IL-12]; Committees: House – Veterans’ Affairs
 
H.R.757 – To amend the Controlled Substances Act to prohibit manufacturing or distributing candy-flavored controlled substances for minors, and for other purposes; Sponsor: Banks, Jim [Rep.-R-IN-3]; Committees: House – Judiciary; Energy and Commerce
 
H.R.762 – To establish the Supply Chain Resiliency and Crisis Response Office in the Department of Commerce, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce
 
H.R.763 – To establish an Office of Manufacturing Security and Resilience in the Department of Commerce, to provide for a Department of Commerce assessment and strategy to counter threats to critical supply chains, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce
 
H.R.766 – To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Budget
 
H.R.767 – To preserve access to abortion medications; Sponsor: Bush, Cori [Rep.-D-MO-1]; Committees: House – Energy and Commerce
 
H.R.772 – To prohibit the Federal Government from issuing vaccine passports, to prohibit businesses from discriminating against patrons and customers by requiring documentation certifying COVID-19 vaccination, or post-transmission recovery, as a condition on the provision of products or services, and for other purposes; Sponsor: Davidson, Warren [Rep.-R-OH-8]; Committees: House – Oversight and Accountability; Energy and Commerce; Education and the Workforce
 
H.R.773 – To help persons in the United States experiencing homelessness and significant behavioral health issues, including substance use disorders, by authorizing a grant program within the Department of Housing and Urban Development to assist State and local governments, Continuums of Care, community-based organizations that administer both health and homelessness services, and providers of services to people experiencing homelessness, better coordinate health care and homelessness services, and for other purposes; Sponsor: Dean, Madeleine [Rep.-D-PA-4]; Committees: House – Financial Services
 
H.R.774 – To establish an Office of Manufacturing Security and Resilience in the Department of Commerce, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce
 
H.R.789 – To amend the Family and Medical Leave Act of 1993 and title 5, United States Code, to permit leave to care for a domestic partner, parent-in-law, or adult child, or another related individual, who has a serious health condition, and to allow employees to take, as additional leave, parental involvement and family wellness leave to participate in or attend their children’s and grandchildren’s educational and extracurricular activities or meet family care needs; Sponsor: Hayes, Jahana [Rep.-D-CT-5]; Committees: House – Education and the Workforce; Oversight and Accountability; House Administration
 
H.R.796 – To establish the Supply Chain Resiliency and Crisis Response Office in the Department of Commerce, and for other purposes; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Energy and Commerce
 
H.R.801 – To amend title III of the Public Health Service Act to provide for suspension of entries and imports from designated countries to prevent the spread of communicable diseases and import into the United States of certain controlled substances; Sponsor: Lesko, Debbie [Rep.-R-AZ-8]; Committees: House – Energy and Commerce
 
H.R.808 – To amend title 38, United States Code, to improve the assignment of patient advocates at medical facilities of the Department of Veterans Affairs; Sponsor: Moolenaar, John R. [Rep.-R-MI-2]; Committees: House – Veterans’ Affairs
 
H.R.812 – To repeal the Inflation Reduction Act of 2022; Sponsor: Ogles, Andrew [Rep.-R-TN-5]; Committees: House – Ways and Means; Energy and Commerce; Agriculture; Natural Resources; Financial Services; Science, Space, and Technology; Transportation and Infrastructure; Oversight and Accountability
 
H.R.814 – To protect benefits provided under Social Security, Medicare, and any other program of benefits administered by the Social Security Administration or the Centers for Medicare and Medicaid Services; Sponsor: Pocan, Mark [Rep.-D- WI-2]; Committees: House – Rules
 
H.R.815 – To amend title 38, United States Code, to make certain improvements relating to the eligibility of veterans to receive reimbursement for emergency treatment furnished through the Veterans Community Care program, and for other purposes; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Veterans’ Affairs
 
H.R.822 – To amend the Public Health Service Act to authorize the Secretary of Health and Human Services, acting through the Assistant Secretary for Mental Health and Substance Use, to award grants to eligible entities to establish or maintain a student mental health and safety helpline, and for other purposes; Sponsor: Stewart, Chris [Rep.-R-UT-2]; Committees: House – Energy and Commerce
 
H.R.824 – To amend title XXVII of the Public Health Service Act, the Employee Retirement Income and Security Act of 1974, and the Internal Revenue Code of 1986 to treat benefits for telehealth services offered under a group health plan or group health insurance coverage as excepted benefits; Sponsor: Walberg, Tim [Rep.-R-MI-5]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means
 
H.R.826 – To establish a National Resilience Center of Excellence in the Department of Commerce, and for other purposes; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Energy and Commerce

The U.S. Department of Health and Human Services Office of the Inspector General (OIG) released a report last week summarizing the findings of its audit of the National Institutes of Health’s (NIH) grant awards to EcoHealth Alliance, NIH’s monitoring of EcoHealth, and EcoHealth’s use of grant funds, including its monitoring of subawards to a foreign entity. The audit examined three NIH awards to EcoHealth totaling approximately $8 million, which included $1.8 million of EcoHealth’s subawards to eight subrecipients, including the Wuhan Institute of Virology (WIV). OIG concludes that despite identifying potential risks associated with research being performed under the EcoHealth awards, NIH did not effectively monitor or take timely action to address EcoHealth’s compliance with some requirements. Other deficiencies in the oversight of the awards identified by OIG include NIH’s improper termination of a grant; EcoHealth’s inability to obtain scientific documentation from WIV; and EcoHealth’s improper use of grant funds, resulting in $89,171 in unallowable costs. The report will be discussed during a congressional hearing scheduled for February 1 before the House Energy and Commerce Subcommittee on Oversight and Investigations.

 

Membership of the Select Subcommittee on the Coronavirus Pandemic

House Speaker Kevin McCarthy (R-Calif.) named the members of the Select Subcommittee on the Coronavirus Pandemic last week. The panel, which was established by the new rules package adopted by the House of Representatives earlier this month, will be comprised of Chair Brad Wenstrup (R-Ohio) alongside Reps. Nicole Malliotakis (R-N.Y.), Mariannette Miller-Meeks (R-Iowa), Debbie Lesko (R-Ariz.), Michael Cloud (R-Texas), John Joyce (R-Pa.), Marjorie Taylor Greene (R-Ga.), Ronny Jackson (R-Texas) and Rich McCormick (R-Ga.). The subcommittee, which is housed within the House Committee on Oversight and Accountability, has been charged with investigating the origins of COVID-19, the use of taxpayer funding and relief programs to address the pandemic, the efficacy of the federal government’s pandemic preparedness and response to the spread of COVID-19, and the nation’s implementation of vaccine policies.

 

Health Panel Leadership Preview Agendas for 118th Congress

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) announced last week that Rep. Brett Guthrie (R-Ky.) will serve as the new chair of panel’s Health Subcommittee. Guthrie has previewed his agenda for the 118th Congress, stating that he plans to focus on health care price transparency, issues related to fentanyl, drug scheduling, and mental health, and expanding access to telehealth in a sustainable way.
Rep. Vern Buchanan (R-Fla.) will serve as chair of the Ways and Means Health Subcommittee, as well as the vice chair of the full panel. Buchanan was a co-chair of the Republicans’ Healthy Future Task Force last congress, which focused on the opioid crisis, modernizing health care delivery, and reducing health care costs. Rep. Lloyd Doggett (D-Texas) will continue to serve as the subcommittee’s ranking member. Doggett has said that his top priority will be protecting Medicare from any Republican attempts to scale back the program, while ensuring equitable access to telehealth and preventing telehealth fraud and abuse represents a potential area of bipartisan compromise.
On the Senate side, Finance Committee Chair Ron Wyden (D-Ore.) has discussed his plans to expand upon his previous work on the CHRONIC Care Act. The law, spearheaded by Wyden and the late Sen. Orrin Hatch (R-Utah), expanded access to telehealth in the Medicare Advantage program as well as at-home dialysis care. In addition to further allowing Medicare to pay for nonmedical services for people with chronic conditions, Wyden also plans to focus on the role of pharmacy benefit managers and mental health issues – including payment parity, workforce challenges, and ghost networks – in the 118th Congress. Wyden has also pledged to investigate broader health care workforce issues such as nursing shortages.
Hart Health Strategies Inc. continues to track the latest committee leadership and roster announcements in our Guide to the 118th Congress, which is updated on an ongoing basis. This living document provides a list of health professionals serving in Congress, House and Senate leadership, congressional health committee members, and biographies on new members of Congress.

 

Schiff Announces Run for CA Senate Seat

Rep. Adam Schiff (D-Calif.) announced that he will run for Sen. Dianne Feinstein’s (D-Calif.) seat in the Senate in 2024. Schiff served as the lead prosecutor during the first impeachment trial of former President Donald Trump in 2020. Feinstein has yet to announce whether she will run for re-election, but the five-term senator, 89, is widely expected to retire.

 

GAO Releases New Report on Pandemic Relief Funds

The Government Accountability Office (GAO) released a report last week reviewing how the U.S. Department of Health and Human Services (HHS) allocated certain pandemic relief funds to support communities disproportionately affected by COVID-19. The report provides details about the $75 billion provided by HHS to four agencies – the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Indian Health Service, and the Office of Minority Health – which directed about $29 billion (over 35%) to support these communities. The agencies distributed another $33 billion – often to state health departments – with a recommendation to support these communities. GAO found that state officials often faced delays in acceptance of federal funds as well as capacity challenges that constrained their efforts to allocate and use the funds.

 

FDA Panel Recommends Harmonizing COVID-19 Vaccines

The Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend matching the composition of primary COVID-19 vaccine doses and booster doses during its meeting last week. This would result in the phasing out of the original COVID-19 vaccine and making all COVID-19 vaccines consist of the updated bivalent dose. If the VRBPAC’s recommendation is endorsed by the FDA and the CDC, a single vaccine composed of the updated bivalent shot will be used for both vaccinated and unvaccinated people going forward.

 

Advocates Celebrate Elimination of X-Waiver at White House Event

The Biden administration recognized the end of the x-waiver requirement in an event featuring federal officials, substance use disorder treatment advocates, and legislative champions at the White House last week. The Mainstreaming Addiction Treatment (MAT) Act, which was included in the year-end omnibus legislation signed into law late last year, eliminates the special training and required waiver process for prescribers of the opioid use disorder treatment buprenorphine. Supporters of the change say that elimination of the burdensome x-waiver requirement will increase access to addiction treatment, reduce the number of fatal opioid overdoses, and lessen the stigma around the use and prescription of buprenorphine.
 

POLICY BRIEFINGS

 

CDC Announces Internal Reorganization

The Centers for Disease Control and Prevention (CDC) announced several internal structural changes to the agency last week. Most of the CDC will now report directly to the Immediate Office of the Director, a change from the structure known as “Community of Practice” previously in place. According to staff familiar with the changes, a centralized leadership team of multi-disciplinary experts including the CDC director, chief of staff, and several deputy directors will be created to supervise the agency. The Center for Surveillance, Epidemiology, and Laboratory Services and the Center for State, Tribal, Local, and Territorial Support will be combined into a new agency entity called the National Center for State, Tribal, Local, and Territorial Public Health Infrastructure and Workforce. The Center for Preparedness and Response will be renamed the Office of Readiness and Response. Several new offices will also be created, including the Office of Health Equity and the Office of Public Health Data, Surveillance, and Technology. The reorganization follows Director Rochelle Walensky’s recognition last year that the CDC’s performance in responding to the COVID-19 pandemic did not meet expectations.
 

Upcoming Congressional Hearings and Markups

House Rules Committee meeting on H.J. Res. 7 – Relating to a national emergency declared by the President on March 13, 2020; H.R. 139 – SHOW UP Act; H.R. 382 – Pandemic is Over Act; and H.R. 497 – Freedom for Health Care Workers Act; 5:00 p.m.; January 30

 

House Energy and Commerce Subcommittee on Health hearing “Lives Worth Living: Addressing the Fentanyl Crisis, Protecting Critical Lifelines, and Combatting Discrimination Against Those with Disabilities;” 10:00 a.m.; February 1

 

House Oversight and Accountability Committee hearing “Federal Pandemic Spending: A Prescription for Waste, Fraud and Abuse;” 10:00 a.m.; February 1

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Challenges and Opportunities to Investigating the Origins of Pandemics and Other Biological Events;” 2:00 p.m.; February 1

 

Recently Introduced Health Legislation

H.R.445 – To establish within the Department of Health and Human Services an Ombuds for Reproductive and Sexual Health. Sponsor: Williams, Nikema [Rep.-D-GA-5]; Committees: House – Energy and Commerce

 

H.R.437 – To amend title X of the Public Health Service Act to require grant recipients to comply with all applicable State and local laws requiring notification or reporting of child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence, or human trafficking, and for other purposes. Sponsor: Smucker, Lloyd [Rep.-R-PA-11]; Committees: House – Energy and Commerce

 

H.R.436 – To prohibit United States contributions to the United Nations Population Fund. Sponsor: Roy, Chip [Rep.-R- TX-21]; Committees: House – Foreign Affairs

 

H.R.435 – To prohibit the award of Federal funds to an institution of higher education that hosts or is affiliated with a student-based service site that provides abortion drugs or abortions to students of the institution or to employees of the institution or site, and for other purposes. Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Education and the Workforce

 

H.R.434 – To establish certain protections for a member of the Armed Forces, or a cadet or midshipman at a military service academy, who refuses to receive a vaccination against COVID-19. Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Armed Services

 

H.R.431 – To implement equal protection under the 14th article of amendment to the Constitution for the right to life of each born and preborn human person. Sponsor: Mooney, Alexander X. [Rep.-R-WV-2]; Committees: House – Judiciary

 

H.R.429 – To amend the Internal Revenue Code of 1986 to deny the trade or business expense deduction for the reimbursement of employee costs of child gender transition procedure or travel to obtain an abortion. Sponsor: Mast, Brian J. [Rep.-R-FL-21]; Committees: House – Ways and Means

 

H.R.428 – To amend title 18, United States Code, to prohibit the unlawful disposal of fetal remains. Sponsor: Latta, Robert E. [Rep.-R-OH-5]; Committees: House – Judiciary

 

H.R.427 – To amend the Federal Food, Drug, and Cosmetic Act to prohibit the approval of new abortion drugs, to prohibit investigational use exemptions for abortion drugs, and to impose additional regulatory requirements with respect to previously approved abortion drugs, and for other purposes. Sponsor: Latta, Robert E. [Rep.-R-OH-5]; Committees: House – Energy and Commerce

H.R.421 – To prohibit chemical abortions performed without the presence of a healthcare provider, and for other purposes. Sponsor: Good, Bob [Rep.-R-VA-5]; Committees: House – Judiciary

 

H.R.420 – To amend title XVIII of the Social Security Act to provide for enhanced Medicare beneficiary information through access to annual Medicare notifications in multiple languages. Sponsor: Gomez, Jimmy [Rep.-D-CA-34]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.417 – To provide a set-aside of funds for Indian populations under the health profession opportunity grant program under section 2008 of the Social Security Act, and for other purposes. Sponsor: Gomez, Jimmy [Rep.-D-CA-34]; Committees: House – Ways and Means

 

H.R.416 – To amend title IV of the Public Health Service Act to prohibit sale or transactions relating to human fetal tissue. Sponsor: Franklin, C. Scott [Rep.-R-FL-18]; Committees: House – Energy and Commerce

 

H.R.411 – To ensure that Members of Congress and Congressional staff receive health care from the Department of Veterans Affairs instead of under the Federal Health Benefits Program or health care exchanges. Sponsor: Davidson, Warren [Rep.-R-OH-8]; Committees: House – House Administration; Veterans’ Affairs

 

H.R.410 – To amend the Public Health Service Act to provide for hospital and insurer price transparency. Sponsor: Davidson, Warren [Rep.-R-OH-8]; Committees: House – Energy and Commerce

 

H.R.407 – To prohibit the use of Federal funds to implement Executive order relating to reproductive health services. Sponsor: Clyde, Andrew S. [Rep.-R-GA-9]; Committees: House – Energy and Commerce; Judiciary; Ways and Means

 

H.R.405 – To amend the Public Health Service Act to provide for stockpiles to ensure that all Americans have access to generic drugs at risk of shortage, and for other purposes. Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.403 – To prohibit COVID-19 vaccination mandates, and for other purposes. Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Oversight and Accountability; House Administration; Energy and Commerce

 

H.R.401 – To prohibit the Director of the National Science Foundation from awarding grants and other forms of assistance to Chinese communist military companies and their affiliates, and for other purposes. Sponsor: Allen, Rick W. [Rep.-R-GA-12]; Committees: House – Science, Space, and Technology

 

H.R.398 – To amend the Public Health Service Act to prohibit the Secretary of Health and Human Services from conducting or supporting any research involving human fetal tissue that is obtained pursuant to an induced abortion, and for other purposes. Sponsor: Luetkemeyer, Blaine [Rep.-R-MO-3]; Committees: House – Energy and Commerce

 

S.Res.12 – A resolution designating January 23, 2023, as “Maternal Health Awareness Day”; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Judiciary

 

S.8 – A bill to amend the Internal Revenue Code of 1986 to expand eligibility for the refundable credit for coverage under a qualified health plan, to improve cost-sharing subsidies under the Patient Protection and Affordable Care Act, and for other purposes; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Finance

 

S.15 – A bill to amend title XIX of the Social Security Act and the Public Health Service Act to improve the reporting of abortion data to the Centers for Disease Control and Prevention, and for other purposes; Sponsor: Ernst, Joni [Sen.-R-IA]; Committees: Senate – Finance

 

S.18 – A bill to amend title 18, United States Code, to prohibit discrimination by abortion against an unborn child on the basis of Down syndrome; Sponsor: Daines, Steve [Sen.-R-MT]; Committees: Senate – Judiciary

 

S.24 – A bill to fight homelessness in the United States by authorizing a grant program within the Health Resources and Services Administration for housing programs that offer comprehensive services and intensive case management for homeless individuals and families; Sponsor: Feinstein, Dianne [Sen.-D-CA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.33 – A bill to rescue domestic medical product manufacturing activity by providing incentives in economically distressed areas of the United States and its possessions; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Finance

 

S.36 – A bill to review domestic biopharmaceutical manufacturing capabilities in order to improve public health and medical preparedness and response capabilities and domestic biopharmaceutical manufacturing capabilities; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.48 – A bill to amend title V of the Social Security Act to establish a grant program for community-based maternal mentoring programs; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Finance

 

S.55 – A bill to limit the detailing of directors of medical centers of the Department of Veterans Affairs to different positions within the Department, and for other purposes; Sponsor: Boozman, John [Sen.-R-AR]; Committees: Senate – Veterans’ Affairs

 

H.Res.55 – Recognizing the roles and the contributions of Americas Certified Registered Nurse Anesthetists (CRNAs) and their critical role in providing quality health care for the public and the Nation’s Armed Forces for more than 150 years, through multiple public health emergencies, and beyond; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

H.R.451 – To amend title 18, United States Code, to criminalize abuse with respect to assisted reproductive technology, and for other purposes; Sponsor: Bice, Stephanie I. [Rep.-R-OK-5]; Committees: House – Judiciary

 

H.R.456 – To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.459 – To ensure the privacy of pregnancy termination or loss information under the HIPAA privacy regulations and the HITECH Act; Sponsor: Eshoo, Anna G. [Rep.-D-CA-16]; Committees: House – Energy and Commerce

 

H.R.461 – To amend title 18, United States Code, to prohibit discrimination by abortion against an unborn child on the basis of Down syndrome; Sponsor: Estes, Ron [Rep.-R-KS-4]; Committees: House – Judiciary

 

H.R.467 – To amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other purposes; Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce; Judiciary

 

H.R.468 – To amend title XI of the Social Security Act to extend beyond the COVID-19 emergency period, with certain modifications, the Emergency Declaration Blanket Waiver relating to training and certification of nurse aides to alleviate burdens imposed on staff of skilled nursing facilities and nursing facilities; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.472 – To require the Attorney General to propose a program for making treatment for post-traumatic stress disorder and acute stress disorder available to public safety officers, and for other purposes; Sponsor: Joyce, David P. [Rep.-R- OH-14]; Committees: House – Judiciary

 

H.R.477 – To amend title V of the Social Security Act to establish a grant program for community-based maternal mentoring programs; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House – Energy and Commerce

 

H.R.485 – To amend title XI of the Social Security Act to prohibit the use of quality-adjusted life years and similar measures in coverage and payment determinations under Federal health care programs; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.492 – To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to establish a patient outreach system relating to mental health care, and for other purposes; Sponsor: Wittman, Robert J. [Rep.-R-VA-1]; Committees: House – Veterans’ Affairs

S.76 – A bill to require the Secretary of Health and Human Services to furnish tailored information to expecting mothers, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions
Recently Introduced Health Legislation Contd.

 

S.79 – A bill to amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Judiciary

 

S.80 – A bill to establish an Inspector General of the National Institutes of Health; Sponsor: Blackburn, Marsha [Sen.-R- TN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.81 – A bill to provide a moratorium on all Federal research grants provided to any institution of higher education or other research institute that is conducting gain-of-function research; Sponsor: Marshall, Roger [Sen.-R-KS]; Latest Action: Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.

 

H.R.497 – To eliminate the COVID-19 vaccine mandate on health care providers furnishing items and services under certain Federal health care programs; Sponsor: Duncan, Jeff [Rep.-R-SC-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.498 – To amend title V of the Public Health Service Act to secure the suicide prevention lifeline from cybersecurity incidents, and for other purposes; Sponsor: Obernolte, Jay [Rep.-R-CA-23]; Committees: House – Energy and Commerce

 

H.R.501 – To amend the Controlled Substances Act to require registrants to decline to fill certain suspicious orders, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce; Judiciary

 

H.R.516 – To fight homelessness in the United States by authorizing a grant program within the Health Resources and Services Administration for housing programs that offer comprehensive services and intensive case management for homeless individuals and families; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Financial Services

 

H.R.517 – To require the Secretary of Health and Human Services to furnish tailored information to expecting mothers, and for other purposes; Sponsor: Mace, Nancy [Rep.-R-SC-1]; Committees: House – Energy and Commerce

 

H.R.526 – To amend the Occupational Safety and Health Act of 1970 to prohibit the Secretary of Labor from issuing a temporary standard with respect to COVID-19 vaccination or testing, and for other purposes; Sponsor: Tenney, Claudia [Rep.-R-NY-24]; Committees: House – Education and the Workforce

 

H.R.527 – To void existing non-compete agreements for any employee who is fired for not complying with an employer’s COVID-19 vaccine mandate, and for other purposes; Sponsor: Tenney, Claudia [Rep.-R-NY-24]; Committees: House – Education and the Workforce; Energy and Commerce

S.95 – A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the approval of new abortion drugs, to prohibit investigational use exemptions for abortion drugs, and to impose additional regulatory requirements with respect to previously approved abortion drugs, and for other purposes; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.100 – A bill to amend title XIX of the Social Security Act to expand access to home and community-based services (HCBS) under Medicaid, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.109 – A bill to amend title XXI of the Social Security Act to prohibit lifetime or annual limits on dental coverage under the Children’s Health Insurance Program, and to require wraparound coverage of dental services for certain children under such program; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Finance

 

S.113 – A bill to require the Federal Trade Commission to study the role of intermediaries in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations, and for other purposes; Sponsor: Grassley, Chuck [Sen.-R-IA]; Committees: Senate – Judiciary

S.114 – A bill to amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate – Budget

 

S.121 – A bill to amend the Child Nutrition Act of 1966 to require the provision of training and information to certain personnel relating to food allergy identification and response, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D- IL]; Committees: Senate – Agriculture, Nutrition, and Forestry

 

S.127 – A bill to prevent unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs, and for other purposes; Sponsor: Cantwell, Maria [Sen.-D- WA]; Committees: Senate – Commerce, Science, and Transportation

H.Res.66 – Expressing support for Congress to focus on artificial intelligence; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Latest Action: House – 01/26/2023 Referred to the House Committee on Science, Space, and Technology

H.R.542 – To amend title 38, United States Code, to improve certain programs of the Department of Veterans Affairs for home and community based services for veterans, and for other purposes; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Latest Action: House – 01/26/2023 Referred to the House Committee on Veterans’ Affairs

H.R.543 – To amend title 38, United States Code, to improve the reimbursement of continuing professional education expenses for health care professionals of the Department of Veterans Affairs; Sponsor: Brownley, Julia [Rep.-D-CA-26]; Latest Action: House – 01/26/2023 Referred to the House Committee on Veterans’ Affairs

 

H.R.544 – To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to provide coverage for infertility treatment and standard fertility preservation services, and for other purposes; Sponsor: Brownley, Julia [Rep.-D- CA-26]; Latest Action: House – 01/26/2023 Referred to the House Committee on Veterans’ Affairs

 

H.R.547 – To amend title XIX of the Social Security Act to expand access to home and community-based services (HCBS) under Medicaid, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Latest Action: House – 01/26/2023 Referred to the House Committee on Energy and Commerce.

 

H.R.549 – To amend title II of the Social Security Act to eliminate the waiting periods for disability insurance benefits and Medicare coverage for individuals with metastatic breast cancer, and for other purposes; Sponsor: Garbarino, Andrew R. [Rep.-R-NY-2]; Latest Action: House – 01/26/2023 Referred to the House Committee on Ways and Means

 

H.R.555 – To amend the Defense Production Act of 1950 to ensure the supply of certain medical materials essential to national defense, and for other purposes; Sponsor: Hill, J. French [Rep.-R-AR-2]; Latest Action: House – 01/26/2023 Referred to the House Committee on Financial Services.

 

H.R.561 – To ensure affordable abortion coverage and care for every person, and for other purposes; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Latest Action: House – 01/26/2023 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Natural Resources, Armed Services, Veterans’ Affairs, the Judiciary, Oversight and Accountability, and Foreign Affairs.

 

H.R.568 – To amend the Controlled Substances Act with respect to fentanyl-related substances, and for other purposes; Sponsor: Pappas, Chris [Rep.-D-NH-1]; Latest Action: House – 01/26/2023 Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary.

 

H.R.574 – To prohibit the provision of Federal funds to the National Institutes of Health for the purposes of conducting biological, medical, or behavioral research involving the testing of dogs; Sponsor: Steube, W. Gregory [Rep.-R-FL-17]; Latest Action: House – 01/26/2023 Referred to the House Committee on Energy and Commerce.

Republicans continue to call on the White House and Democrats in Congress to engage in negotiations to increase the federal debt limit. The U.S. reached its $31.4 trillion debt limit on January 19, prompting the Treasury Department to begin taking “extraordinary measures” to delay a default on the national debt and urging Congress to act quickly. Treasury is projected to exhaust its borrowing authority around June of this year, and House Republicans are pushing for an agreement on spending cuts in exchange for increasing the statutory ceiling for the federal debt. House Speaker Kevin McCarthy (R-Calif.) has indicated that changes to entitlement programs as well as to annual discretionary spending are both under consideration. Biden administration officials, however, remain opposed to any bargaining around the debt limit, arguing that the nation’s borrowing authority should be addressed without conditions and is not something that should be politicized. While congressional Democratic leadership appear aligned with this position, Sen. Joe Manchin (D-W.Va.) stated last week that he is willing to seek a deal with Republicans on the debt limit. Manchin specifically expressed support for Sen. Mitt Romney’s (R-Utah) plan to create commissions charged with making recommendations to extend the solvency of the Medicare and Social Security trust funds. Romney’s proposal would guarantee a vote on the commissions’ recommendations before Congress. Senate Minority Leader Mitch McConnell (R-Ky.) has offered assurances that the nation will not breach the debt limit and expressed his confidence that talks with President Joe Biden on a spending compromise will resolve any standoffs.

 

Banks, Gallego Announce Senate Intentions

Rep. Jim Banks (R-Ind.) announced that he will run for Sen. Mike Braun’s (R-Ind.) seat in the Senate in 2024. Braun decided last year to retire from Congress and run for Indiana governor in 2024. Rep. Ruben Gallego (D-Ariz.) also announced his plans to challenge Sen. Kyrsten Sinema (I-Ariz.) for her seat in the Senate in 2024 last week. Gallego currently serves on the House Committee on Armed Services, the Committee on Natural Resources, and the Committee on Veterans’ Affairs. Sinema has yet to decide whether she will seek re-election after leaving the Democratic Party and becoming an independent late last year.

 

GAO Report Raises Concerns with Gain of Function Research Oversight

Anew report from the Government Accountability Office (GAO) examining the U.S. Department of Health and Human Services’ (HHS) oversight of gain-of-function research was released last week. The report expresses concerns about the effectiveness of and lack of transparency around grantee monitoring, and describes shortcomings related to the review of research proposals involving potential pandemic pathogens. While HHS is required to conduct extra reviews of the risks and benefits of research grant proposals that are “reasonably anticipated to create, transfer, or use enhanced potential pandemic pathogens,” there is no standard for what this actually means. The GAO recommends that HHS set a standard to ensure consistency in identifying high-risk research for departmental review and identify and share non-sensitive information with researchers, Congress, and the public about the review process. In response to the report, Republicans in the House of Representatives reiterated their intent to further investigate HHS funding of research involving pathogens with pandemic potential. House Oversight and Accountability Chair James Comer (R-Ky.) and House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) both plan to conduct investigations into gain-of- function research and its potential role in the cause of the COVID-19 pandemic.

 

Pallone Highlights Lack of Clinical Trial Transparency Enforcement

House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.) has sent a letter to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) regarding the agencies’ enforcement of regulations governing clinical trial transparency. Trials that are subject to FDA oversight and NIH funding are required to register their studies within 21 days of their first subject enrollment and post their results within a year of the trial’s completion. While the FDA released guidance on penalties for non-compliance with these standards in 2020, only four non-compliance notices have been posted – and none required the subjects to pay a civil money penalty. Pallone cites a study indicating that 31% of registered trials failed to report any results, while another 30% of trial sponsors failed to do so on time. He requests a response from the agencies by February 17 regarding clinical trial sponsor compliance with applicable requirements and appropriate agency enforcement.

 

Study Shows Barriers to Psychiatric Care for Military Families

Up to 35% of military families do not have access to adequate psychiatric care despite being insured by a government program that covers these services, according to a new study published in JAMA Network Open. The study found that 35% of Tricare beneficiaries lived in communities where the ratio of residents to psychiatrists – military or civilian – is more than 20,0000 to one, and another 6% lived more than 30 minutes driving distance from a psychologist. Individuals living in places with both low incomes and high-income inequality were more than two times more likely to face a shortage of psychiatrists, while retirees were nearly twice as likely to experience shortages and four times as likely to have no access to psychiatric care at all.

 

Recently Introduced Health Legislation

H.R.366 – To amend title 38, United States Code, to treat certain individuals who served in Vietnam as a member of the armed forces of the Republic of Korea as a veteran of the Armed Forces of the United States for purposes of the provision of health care by the Department of Veterans Affairs. Sponsor: Takano, Mark [Rep.-D-CA-39]; Committees: House – Veterans’ Affairs

 

H.R.363 – To amend title 18, United States Code, with respect to the sale, purchase, shipment, receipt, or possession of a firearm or ammunition by a user of medical marijuana, and for other purposes. Sponsor: Mooney, Alexander X. [Rep.-R- WV-2]; Committees: House – Judiciary

 

H.R.382 – To terminate the public health emergency declared with respect to COVID-19; Sponsor: Guthrie, Brett [Rep.- R-KY-2]; Committees: House – Energy and Commerce

 

H.R.383 – To nullify the modifications made by the Food and Drug Administration in January 2023 to the risk evaluation and mitigation strategy for the abortion pill mifepristone, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R- TN-1]; Committees: House – Energy and Commerce

 

H.R.384 – To prohibit the use or declaration of a public health emergency with respect to abortion, and for other purposes; Sponsor: Hern, Kevin [Rep.-R-OK-1]; Committees: House – Energy and Commerce

The House of Representatives approved a new rules package setting the chamber’s operating procedures for the 118th Congress last week. Unlike the Senate, which operates under standing rules from session to session, the House must adopt a new package of rules at the beginning of each new Congress to set the procedures by which the chamber considers and passes legislation. The rules allow a single House member to make a motion to vote the House speaker from leadership. This ‘motion to vacate’ concession was made by Speaker Kevin McCarthy (R-Calif.) as a part of his speakership election negotiations. The rules package replaces “pay as you go” (PAYGO) requirements with “cut-as-you-go” (CUTGO) which requires spending offsets for any legislation that increases the budget and requires that any tax rate increase be supported by three-fifths of the chamber. The new rules also officially end COVID-19-era remote work provisions as well as reinstate the Holman Rule, which allows members to introduce amendments to appropriations bills to make cuts to specific federal programs or fire or make pay cuts for specific government employees. The Holman Rule was last in place during the 115th Congress, but no amendments proposed were ever signed into law. The rules provided for consideration of several GOP legislative priorities – including the rescission of Internal Revenue Service funding, a ban on taxpayer-funded abortions, and an increase of oil and gas production on public land. It also set votes to establish two new congressional panels – the House Judiciary Subcommittee on Weaponization of the Federal Government and a Select Committee on the Strategic Competition between the U.S. and China.

 

House Passes Born- Alive Legislation

The House of Representatives passed the Born-Alive Abortion Survivors Protection Act (H.R. 26) last week. The legislation passed by a vote of 220-210, with Rep. Henry Cuellar (D-Texas) joining Republicans in support of the bill. H.R. 26 outlines requirements for health care providers to treat children born after an attempted abortion. The legislation establishes criminal penalties for health practitioners who fail to provide required care or fail to report such failure. The new House Republican majority have pledged to pass abortion restrictions during the 118th Congress. It is unlikely that any such bills will be considered in the Democratic-controlled Senate.

 

MO Republican Jason Smith to Chair Ways and Means

The House GOP Steering Committee selected Rep. Jason Smith (R-Mo.) to replace retired Rep. Kevin Brady (R-Texas) as chair of the House Committee on Ways and Means for the 118th Congress. Reps. Vern Buchanan (R-Fla.) and Adrian Smith (R-Neb.) were also vying for the position. Smith’s selection is still subject to approval by the full House Republican Caucus, which typically aligns with the Steering panel’s recommendation. A press release following Smith’s selection as chair outlined the focus of the Ways and Means Committee over the next two years on delivering more jobs, higher wages, and greater investment in America, including by building financial and health care security for families and re-shoring and strengthening supply chains to create medical independence. The Ways and Means Committee will also play a key role in negotiations to raise the debt ceiling later this year.

During the 117th Congress Rep. Smith was a champion of legislation to help ensure Medicare recipients who cannot access video during telehealth visits are able to access care through audio-only visits, as well as a bill that would require Medicare to permanently cover audio-only telehealth services for beneficiaries. He also helped introduce the Increasing Mental Health Options Act of 2022, which aims to ensure Medicare beneficiaries have access to clinical psychologists across all settings of care. Smith has opposed the Biden administration’s COVID-19 vaccine mandates and characterized a proposal to incorporate “anti-racism plans” as a quality metric for physicians under the Merit-based Incentive Payment Systems as discriminatory.

 

Agreement Reached on House Committee Ratios

House Democratic Leader Hakeem Jeffries (D-N.Y.) announced over the weekend that Democrats in the House of Representatives have reached an agreement with Republicans regarding ratios on so-called “A” or “exclusive” committees. Those committees are Appropriations, Energy and Commerce, Financial Services, and Ways and Means. Of those four committees, Appropriations will see one seat added to the majority and minority side, while Energy and Commerce will be reduced by three seats each for the majority and minority, and Financial Services reduced by one seat. The Ways and Means Committee ratio will stay the same. While official committee rosters will not be released by the Democrats until after the Democratic Steering and Policy Committee meets, the practical effect of this announcement could mean no new Democratic appointments on Energy and Commerce and Appropriations and a potential loss of a few Democrats on the Ways and Means Committee.

The latest information on recently announced changes to congressional committee membership can be found in Hart Health Strategies Inc.’s Guide to the 118th Congress, which is updated on an ongoing basis.

 

Sanders Presses Moderna on Possible Vaccine Price Hike

Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bernie Sanders (I-Vt.) has sent a letter to Moderna urging the company to reconsider and refrain from any decision to raise the price of its COVID-19 vaccine for non-government payers. The Wall Street Journal recently reported that the company is considering an increase to the price of the vaccine as it shifts from government contracts to private insurers for the distribution of the vaccine. Sanders argues that reports of Moderna considering raising the price of its COVID-19 vaccine from $26.36 to up to $130 per dose are “particularly offensive” because the federal government provided $1.7 billion to Moderna for vaccine research and development in partnership with the National Institutes of Health. This increase would “make the vaccine unaffordable for the residents of this country who made the production of the vaccine possible,” Sanders writes.

 

Democrats Ask HHS to Use March-In Rights for Prostate Cancer Treatment

Sen. Elizabeth Warren (D-Mass.), Sen. Angus King (I-Maine), and Rep. Lloyd Doggett (D-Texas) have sent a letter to the U.S. Department of Health and Human Services (HHS) urging the Secretary to use the federal government’s march- in rights under the Bayh-Dole Act to address the price of prostate cancer treatment Xtandi. The letter asserts that despite being developed with the support of federal funding, Americans pay as much as six times the cost paid by patients in other countries for Xtandi. The lawmakers urge HHS to grant patent licenses for generic manufacturers to produce the drug.

 

Former NE Governor Ricketts to Replace Sasse in Senate

Former Nebraska Governor Pete Ricketts (R) has been appointed by Gov. Jim Pillen (R) to fill the seat vacated by the retirement of Sen. Ben Sasse (R). Ricketts will serve through at least November 2024, when a special election will be held to fill the remaining two years of Sasse’s term. Ricketts has committed to running in 2024 and, should he win, in 2026 to serve a full six-year term in the Senate. The former two-term governor co-chaired the Republican Governors Association during the 2022 campaign cycle. During his time as Nebraska governor, Ricketts worked to improve access to mental health services for service members, veterans, and their families and acted to address both ongoing and pandemic-related health care workforce shortages.

 

POLICY BRIEFINGS

 

President to Deliver State of the Union Address Feb. 7

President Joe Biden will deliver his annual State of the Union address to Congress on February 7. The President is expected to tout his legislative victories over the last year, including the infrastructure bill and the Inflation Reduction Act. He will also lay out the administration’s vision for areas of potential bipartisan compromise in the newly divided Congress and is likely to discuss the need to raise the federal government’s borrowing authority this year.

 

Treasury to Begin Extraordinary Measures to Avoid Debt Default

Treasury Secretary Janet Yellen has informed House Speaker Kevin McCarthy (R-Calif.) that the U.S. is projected to reach its $31.4 trillion borrowing limit in less than a week. The Treasury Department will begin taking “extraordinary measures” on January 19 to delay a default on the national debt. Yellen urged Congress to act in a timely manner to raise or suspend the debt ceiling before the extraordinary measures run out, which could occur as early as June. Republicans have pledged that any action to address the debt limit should be tied to spending cuts.

 

COVID-19 PHE Renewed Through April

The Biden administration renewed the COVID-19 public health emergency (PHE) for the 11th, and possibly final, time last week. Senior White House officials are reportedly preparing to end the COVID-19 emergency designation this spring. The administration has pledged to provide a 60 days’ notice before terminating or allowing the PHE to expire – a deadline which has now been pushed until early February given the latest 90-day PHE extension to mid-April. Allowing the PHE to expire would result in the restructuring of the federal COVID-19 response and shift much of the responsibility for vaccine and treatment distribution to the private sector. Other flexibilities and regulatory authorities instituted in response to the COVID-19 PHE would also end, though some measures have already been de-linked from the emergency declaration. The most recent omnibus spending package, for example, included a two-year extension of telehealth policies and permits states to resume Medicaid redeterminations in April. Other provisions, such as the Drug Enforcement Administration’s virtual prescribing of controlled substances waivers, were not extended in the year-end funding bill.

The administration is weighing whether to begin scaling back its COVID-19 team in the coming months or keep it intact through the end of the year. Staff members who leave the administration in the interim, however, are not expected to be replaced, nor will a new chief medical adviser be named following the departure of Anthony Fauci at the end of last year. Although little federal funding for COVID-19 response remains following Congress’ failure to allocate more money last year, the administration continues to work to increase vaccine uptake and make treatments more widely available particularly in response to the rapid spread of the new COVID-19 subvariant XBB.1.5.

 

FLOTUS Undergoes Surgery to Remove Skin Lesions

First Lady Jill Biden underwent Mohs surgery at Walter Reed National Military Medical Center last week to remove two basal cell cancerous lesions. Doctors do not expect any further procedures to be necessary. According to White House physician Dr. Kevin O’Connor, the first lady “is in good spirits and is feeling well.”

 

CMS Announces Distribution of First Tranche of New GME Slots

The Centers for Medicare and Medicaid Services (CMS) announced the distribution of 200 graduate medical education (GME) slots created as a part of the Consolidated Appropriations Act, 2021, which provided for the creation of 1,000 additional Medicare-funded physician residency slots over the course of five years. Of these direct GME slots, 125 of the residency slots are being allocated for primary care (including obstetrics/gynecology), and 20 slots are being allocated for psychiatry. This year’s slots, distributed to 100 teaching hospitals in 30 states, the District of Columbia, and Puerto Rico, will be effective July 1, 2023. The application period for the 200 fiscal year 2024 slots will open later this month and close on March 31, 2023.

 

USPSTF Welcomes Three New Members

The U.S. Preventive Services Task Force (USPSTF) announced the addition of three new members to the task force last week. Each are appointed to serve four-year terms starting this month.

• Dr. Sandra Millon Underwood, R.N., Ph.D., professor emerita in the College of Nursing at the University of Wisconsin-Milwaukee
• Dr. Goutham Rao, M.D., FAHA, chair of the Department of Family Medicine and Community Health, and chief clinician experience officer for the University Hospitals Health System
• Dr. Joel Tsevat, M.D., M.P.H, general internist, professor of medicine, and Joaquin G. Cigarroa, Jr., M.D., distinguished chair in the Joe R. and Teresa Lozano Long School of Medicine at The University of Texas Health Science Center at San Antonio

 

Maine Epidemiologist Chosen for CDC Leadership Post

Nirav Shah, MD, JD has been tapped to serve as Principal Deputy Director of the Centers for Disease Control and Prevention. Shah, a doctor, lawyer, and epidemiologist, currently serves as Director of the Maine Center for Disease Control and Prevention. He will begin working as the CDC’s second-in-command in March. Shah previously served as the president of the Association of State and Territorial Health Officials from March 2021 through September 2022.

 

Gallup Releases Annual Poll on Professional Ethics Ratings

Nurses, doctors, and pharmacists have topped the ranks of Gallup’s measurement of American’s professional ethics ratings. Approximately 79% of U.S. adults say nurses have “very high” or “high” honesty and ethical standards, with medical doctors and pharmacists ranking second and third respectively – with 62% and 58% of Americans rating them highly. All three professions, however, have seen a drop in their ratings since the bumps shown in 2020 at the height of the COVID-19 pandemic. Telemarketers and members of Congress received the lowest ratings, with less than 10% of Americans rating their ethics highly.

 

Recently Introduced Health Legislation

H.Res.7 – Recognizing the importance of access to comprehensive, high-quality, life-affirming medical care for women of all ages; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.Res.9 – Expressing the sense of the House of Representatives that China is responsible for the COVID-19 pandemic and must be held financially liable for $16,000,000,000,000; Sponsor: Nehls, Troy E. [Rep.-R-TX-22]; Committees: House – Foreign Affairs

 

H.J.Res.7 – Relating to a national emergency declared by the President on March 13, 2020; Sponsor: Gosar, Paul A. [Rep.- R-AZ-9]; Committees: House – Transportation and Infrastructure

 

H.R.26 – To amend title 18, United States Code, to prohibit a health care practitioner from failing to exercise the proper degree of care in the case of a child who survives an abortion or attempted abortion; Sponsor: Wagner, Ann [Rep.-R- MO-2]; Committees: House – Judiciary

 

H.R.31 – To amend title XIX of the Social Security Act to provide for a demonstration project under the Medicaid program for political subdivisions of States to provide medical assistance for the expansion population under such program, and for other purposes; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Energy and Commerce

 

H.R.33 – To amend title XVIII of the Social Security Act to provide for coverage of dental, vision, and hearing care under the Medicare program; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.34 – To amend the Social Security Act and the Internal Revenue Code of 1986 to include net investment income tax imposed in the Federal Hospital Insurance Trust Fund and to modify the net investment income tax; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Ways and Means

 

H.R.35 – To amend title XVIII of the Social Security Act to provide for certain reforms with respect to medicare supplemental health insurance policies; Sponsor: Doggett, Lloyd [Rep.-D-TX-37]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.41 – To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to ensure the timely scheduling of appointments for health care at medical facilities of the Department of Veterans Affairs, and for other purposes; Sponsor: Baird, James R. [Rep.-R-IN-4]; Committees: House – Veterans’ Affairs

 

H.R.46 – To authorize funding to increase access to mental health care treatment to reduce gun violence; Sponsor: Jackson Lee, Sheila [Rep.-D-TX-18]; Committees: House – Energy and Commerce; Judiciary

 

H.R.55 – To amend title 18, United States Code, to enhance criminal penalties for health related stalking, and for other purposes; Sponsor: Jackson Lee, Sheila [Rep.-D-TX-18]; Committees: House – Judiciary

 

H.R.62 – To protect health care providers and people seeking reproductive health care services, and for other purposes; Sponsor: Jackson Lee, Sheila [Rep.-D-TX-18]; Committees: House – Energy and Commerce; Judiciary

 

H.R.69 – To abolish the Occupational Safety and Health Administration, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Education and Labor

 

H.R.70 – To abolish the Agency for Toxic Substances and Disease Registry, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.71 – To amend the Federal Food, Drug, and Cosmetic Act to exempt from regulation as devices non-invasive diagnostic devices, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.72 – To prohibit the use of Federal funds to maintain or collect information that can be used to identify any individual to whom a COVID-19 vaccine is administered, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.73 – To prohibit the use of Federal funds for the HHS Reproductive Healthcare Access Task Force; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.74 – To prohibit the use of Federal funds to propose, establish, implement, or enforce any requirement that an individual wear a mask or other face covering, or be vaccinated, to prevent the spread of COVID-19, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.75 – To repeal the authority of the Food and Drug Administration to require that drugs be dispensed only upon prescription, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.76 – To amend title XXVII of the Public Health Service Act to provide for a definition of short-term limited duration insurance, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.77 – To amend the Public Health Service Act to provide for cooperative governing of individual health insurance coverage; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce

 

H.R.79 – To direct the President to withdraw the United States from the Constitution of the World Health Organization, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Foreign Affairs

 

H.R.93 – To require a particular jury instruction in Federal civil actions that include a claim for damages based on negligence arising from the transmission of COVID19; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Judiciary

 

H.R.104 – To require the Secretary of Veterans Affairs to formally recognize caregivers of veterans, notify veterans and caregivers of clinical determinations relating to eligibility for caregiver programs, and temporarily extend benefits for veterans who are determined ineligible for the family caregiver program, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Veterans’ Affairs

 

H.R.105 – To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to furnish hyperbaric oxygen therapy to veterans with traumatic brain injury or post-traumatic stress disorder; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Veterans’ Affairs

 

H.R.106 – To amend the Internal Revenue Code of 1986 to provide that amounts paid for an abortion are not taken into account for purposes of the deduction for medical expenses; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Ways and Means

 

H.R.107 – To amend the Internal Revenue Code of 1986 to allow for tax-advantaged distributions from health savings accounts during family or medical leave, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Ways and Means

 

H.R.109 – To amend the Internal Revenue Code of 1986 to allow an above-the-line deduction for health insurance premiums; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Ways and Means

 

Recently Introduced Health Legislation Contd.

H.R.112 – To repeal the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Energy and Commerce; Ways and Means; Education and Labor; Natural Resources; Judiciary; House Administration; Rules; Appropriations

 

H.R.116 – To amend title 18, United States Code, to prohibit certain abortion procedures, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Judiciary; Energy and Commerce

 

H.R.117 – To prohibit any entity that receives Federal funds from the COVID relief packages from mandating employees receive a COVID-19 vaccine, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Oversight and Reform; Energy and Commerce

 

H.R.118 – To prohibit agencies from issuing vaccine passports, and for other purposes; Sponsor: Biggs, Andy [Rep.-R- AZ-5]; Committees: House – Oversight and Reform; House Administration

 

H.R.119 – To nullify certain executive orders regarding COVID19 vaccine mandates and to prohibit the Secretary of Labor from issuing a rule mandating vaccination against COVID19, and for other purposes; Sponsor: Biggs, Andy [Rep.-R- AZ-5]; Committees: House – Oversight and Reform; Education and Labor; Energy and Commerce; Ways and Means

 

H.R.120 – To direct that certain assessments with respect to toxicity of chemicals be carried out by the program offices of the Environmental Protection Agency, and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Science, Space, and Technology; Energy and Commerce

 

H.R.124 – To amend title XIX of the Social Security Act to provide incentives for education on the risk of renal medullary carcinoma in individuals who are receiving medical assistance under such title and who have Sickle Cell Disease; Sponsor: Green, Al [Rep.-D-TX-9]; Committees: House – Energy and Commerce

 

H.R.127 – To amend the Internal Revenue Code of 1986 to provide an exemption to the individual mandate to maintain health coverage for individuals residing in counties with fewer than 2 health insurance issuers offering plans on an Exchange; to require Members of Congress and congressional staff to abide by the Patient Protection and Affordable Care Act with respect to health insurance coverage; and for other purposes; Sponsor: Biggs, Andy [Rep.-R-AZ-5]; Committees: House – Ways and Means; Energy and Commerce; House Administration; Oversight and Reform

 

H.R.129 – To require the Secretary of Defense to ensure drop boxes are maintained on military installations for the deposit of unused prescription drugs, and for other purposes; Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Armed Services

 

H.R.133 – To amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program; Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.134 – To amend title XVIII of the Social Security Act to remove geographic requirements and expand originating sites for telehealth services; Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.167 – To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain urgent-use compounded medications, and for other purposes; Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce

 

H.R.170 – To direct the Secretary of Health and Human Services, in collaboration with the Assistant Secretary for Preparedness and Response and the Director of the Centers for Disease Control and Prevention, and in coordination with the Secretary of Defense and the Secretary of Homeland Security, to establish a program of entering into partnerships with eligible domestic manufacturers to ensure the availability of qualified personal protective equipment to prepare for and respond to national health or other emergencies, and for other purposes; Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce; Oversight and Reform

 

H.R.171 – To amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other purposes; Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House – Energy and Commerce; Judiciary

 

H.R.175 – To amend title 18, United States Code, to prohibit abortion in cases where a fetal heartbeat is detectable; Sponsor: Kelly, Mike [Rep.-R-PA-16]; Committees: House – Judiciary

 

H.R.177 – To amend title XI of the Social Security Act to ensure nursing facilities report information on medical directors of such facilities; Sponsor: Levin, Mike [Rep.-D-CA-49]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.185 – To terminate the requirement imposed by the Director of the Centers for Disease Control and Prevention for proof of COVID-19 vaccination for foreign travelers, and for other purposes; Sponsor: Massie, Thomas [Rep.-R-KY-4]; Committees: House – Energy and Commerce

 

H.R.197 – To amend title XVIII of the Social Security Act to include store-and-forward technologies as telecommunications systems through which telehealth services may be furnished for payment under the Medicare program; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.198 – To increase reporting requirements and transparency requirements in the 340B Drug Pricing Program, and for other purposes; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.206 – To amend the Federal Food, Drug, and Cosmetic Act to clarify that artificial intelligence and machine learning technologies can qualify as a practitioner eligible to prescribe drugs if authorized by the State involved and approved, cleared, or authorized by the Food and Drug Administration, and for other purposes; Sponsor: Schweikert, David [Rep.-R- AZ-1]; Committees: House – Energy and Commerce

 

H.R.207 – To amend title XVIII of the Social Security Act to provide coverage and payment for certain tests and assistive telehealth consultations, and for other purposes; Sponsor: Schweikert, David [Rep.-R-AZ-1]; Committees: House – Energy and Commerce; Ways and Means; Veterans’ Affairs

 

H.R.219 – To amend title XVIII of the Social Security Act to codify patients’ rights to hospital visitation, and for other purposes; Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.235 – To provide for research and education with respect to triple-negative breast cancer, and for other purposes; Sponsor: Jackson Lee, Sheila [Rep.-D-TX-18]; Committees: House – Energy and Commerce

 

H.R.238 – To amend the Omnibus Crime Control and Safe Streets Act of 1968 to reauthorize the residential substance use disorder treatment program, and for other purposes; Sponsor: Jackson Lee, Sheila [Rep.-D-TX-18]; Committees: House – Judiciary

 

H.R.244 – To amend title XVIII of the Social Security Act to remove the exclusion of Medicare coverage for hearing aids and examinations therefor, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce; Ways and Means

H.R.245 – To establish a grant program for nebulizers in elementary and secondary schools; Sponsor: Jackson Lee, Sheila [Rep.-D-TX-18]; Committees: House – Education and the Workforce; Energy and Commerce

 

H.Res.27 – Condemning attacks on health care facilities, health care personnel, and patients; Sponsor: DeGette, Diana [Rep.-D-CO-1]; Committees: House – Judiciary

 

H.R.271 – To provide for greater accountability with respect to Federal activities and expenditures relating to COVID-19, and for other purposes; Sponsor: Estes, Ron [Rep.-R-KS-4]; Committees: House – Energy and Commerce; Education and the Workforce; Judiciary; Armed Services; Oversight and Accountability

 

H.R.279 – To amend the Public Health Service Act to prohibit governmental discrimination against certain health care providers with certain objections to abortion; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.282 – To amend title XVIII of the Social Security Act to require hospitals reimbursed under the Medicare system to establish and implement security procedures to reduce the likelihood of infant patient abduction and baby switching, including procedures for identifying all infant patients in the hospital in a manner that ensures that it will be evident if infants are missing from the hospital; Sponsor: Jackson Lee, Sheila [Rep.-D-TX-18]; Committees: House – Ways and Means; Judiciary; Energy and Commerce

 

H.R.286 – To amend the Public Health Service Act to authorize grants to health care providers to enhance the physical and cyber security of their facilities, personnel, and patients; Sponsor: Escobar, Veronica [Rep.-D-TX-16]; Committees: House – Energy and Commerce

 

H.R.301 – To amend the State Department Basic Authorities Act of 1956 to authorize rewards regarding the identification of credible information regarding the origins of COVID-19, and for other purposes; Sponsor: Rose, John W. [Rep.-R- TN-6]; Committees: House – Foreign Affairs

 

H.R.305 – To authorize the Secretary of Education to carry out a grant program to assist local educational agencies with ensuring that each elementary and secondary school has at least one registered nurse on staff; Sponsor: Wilson, Frederica S. [Rep.-D-FL-24]; Committees: House – Education and the Workforce; Energy and Commerce

 

H.R.330 – To amend title X of the Public Health Service Act to prohibit family planning grants from being awarded to any entity that performs abortions, and for other purposes; Sponsor: Foxx, Virginia [Rep.-R-NC-5]; Committees: House – Energy and Commerce

 

H.R.343 – To prohibit United States assessed and voluntary contributions to the World Health Organization; Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Foreign Affairs

 

H.R.348 – To require an audit of COVID-19 relief funding; Sponsor: Tenney, Claudia [Rep.-R-NY-24]; Committees: House – Oversight and Accountability

Republican Kevin McCarthy Elected U.S. House Speaker

The House of Representatives elected Republican Kevin McCarthy (Calif.) as Speaker in the early hours of Saturday morning. The tally was 216-212, with Democrats remaining unified in support of Democratic leader Hakeem Jeffries (N.Y.) and six Republicans voting present. The successful 15th ballot followed four days of votes in which 20 GOP dissidents united to deny McCarthy the required votes needed for speaker, arguing that McCarthy was not conservative enough for the position. The protracted speaker contest was one that has not been seen in modern times – not since the Civil War era has Congress required so many rounds of voting to elect a speaker.

McCarthy was eventually able to flip more than a dozen conservative holdouts to end the standoff by agreeing to many of their demands – including reverting the motion to vacate back to what it looked like prior to the 116th congress. This will allow any one member of the majority or minority party to offer a privileged resolution to vacate the chair. The holdouts also successfully demanded that the number of seats on the House Rules Committee be expanded, and that legislation be posted at least 72 hours before votes on the floor. After McCarthy took the oath of office, the House was able to swear in lawmakers and formally open the first session of the 118th congress.

House Rules Package and Legislative Preview

Republicans released their updated rules package on Friday, which is first on the agenda during Monday evening’s session. The rules package must be adopted by January 13 to process payroll for House staff. Text of the package can be found here and a section-by-section summary can be found here.

An additional eight bills and resolutions will be first to be considered in the House during the 118th Congress, including H.R. 26, the Born-Alive Abortion Survivors Protection Act which the sponsors state would prohibit a health care practitioner from failing to exercise the proper degree of care in the case of a child who survives an abortion or attempted abortion.

Expected Renewal of Public Health Emergency

The COVID-19 public health emergency (PHE) first declared in January 2020 and last renewed on October 13, 2022, is expected to be renewed this week by Secretary of Health and Human Services Xavier Becerra. The Biden Administration committed to provide states a 60-day notice before ending the PHE and in the absence of such notice, it is expected that the PHE will be renewed into April rather than end on January 11.

Lawmakers Probe Promotion of Medical Credit Cards

Sens. Elizabeth Warren (D-Mass.), Ed Markey (D-Mass.), Bernie Sanders (I-Vt.), Chris Murphy (D-Conn.), and Sherrod Brown (D-Ohio) are requesting information about potentially deceptive promotions of medical credit cards. The lawmakers sent a letter to Wells Fargo & Co. and Synchrony Financial regarding their credit card offerings intended to cover expensive health care services. “Patients – often under duress because of concerns about their medical care – are being pushed into and then locked into medical credit cards despite the availability of alternative payment options that might be more beneficial and offer lower interest rates,” the letter states. The lawmakers request a response from the lenders by January 12.

Stabenow Announces Decision to Not Seek Another Senate Term

Sen. Debbie Stabenow (D-Mich.) announced last week that she will not run for reelection in 2024. Stabenow currently serves as Chair of the Democratic Policy and Communications Committee and as chair of the Senate Agriculture Committee. She the most senior Democrat on the Senate Finance Committee after Chairman Wyden (D-Ore.). Stabenow was first elected to the House of Representatives in 1996 and became the first women to be elected to the Senate from the state of Michigan in 2000. Reps. Elissa Slotkin (D-Mich.) and Debbie Dingell (D-Mich.) are reportedly considering a bid for Stabenow’s Senate seat.

Boyle to Take Leave from W&M While Serving as Budget Ranking Member

Rep. Brendan Boyle (D-Pa.) will take a temporary leave of absence from the House Ways and Means Committee this congress, following his selection as ranking member of the Budget Committee. This arrangement is in keeping with that chosen by Sen. Chris Van Hollen (D-Md.), who served on Ways and Means Committee but was also chosen to lead Budget Committee Democrats during his time in the House of Representatives. Minority Leader Hakeem Jeffries (D-N.Y.) has approved Boyle’s decision.

Sen. Casey Announces Cancer Diagnosis, Expects Full Recovery

Sen. Bob Casey (D-Pa.) announced last week that he has been diagnosed with prostate cancer. He will undergo surgery in the “coming months.” Casey stated that he expects a full recovery and expressed his confidence that he will be able to continue to serve in the 118th congress with “minimal disruption.”

The House of Representatives elected Republican Kevin McCarthy (Calif.) as Speaker in the early hours of Saturday morning. The tally was 216-212, with Democrats remaining unified in support of Democratic leader Hakeem Jeffries (N.Y.) and six Republicans voting present. The successful 15th ballot followed four days of votes in which 20 GOP dissidents united to deny McCarthy the required votes needed for speaker, arguing that McCarthy was not conservative enough for the position. The protracted speaker contest was one that has not been seen in modern times – not since the Civil War era has Congress required so many rounds of voting to elect a speaker.

McCarthy was eventually able to flip more than a dozen conservative holdouts to end the standoff by agreeing to many of their demands – including reverting the motion to vacate back to what it looked like prior to the 116th congress. This will allow any one member of the majority or minority party to offer a privileged resolution to vacate the chair. The holdouts also successfully demanded that the number of seats on the House Rules Committee be expanded, and that legislation be posted at least 72 hours before votes on the floor. After McCarthy took the oath of office, the House was able to swear in lawmakers and formally open the first session of the 118th congress.

 

House Rules Package and Legislative Preview

Republicans released their updated rules package on Friday, which is first on the agenda during Monday evening’s session. The rules package must be adopted by January 13 to process payroll for House staff. Text of the package can be found here and a section-by-section summary can be found here.

An additional eight bills and resolutions will be first to be considered in the House during the 118th Congress, including H.R. 26, the Born-Alive Abortion Survivors Protection Act which the sponsors state would prohibit a health care practitioner from failing to exercise the proper degree of care in the case of a child who survives an abortion or attempted abortion.
Expected Renewal of Public Health Emergency

The COVID-19 public health emergency (PHE) first declared in January 2020 and last renewed on October 13, 2022, is expected to be renewed this week by Secretary of Health and Human Services Xavier Becerra. The Biden Administration committed to provide states a 60-day notice before ending the PHE and in the absence of such notice, it is expected that the PHE will be renewed into April rather than end on January 11.

 

Lawmakers Probe Promotion of Medical Credit Cards

Sens. Elizabeth Warren (D-Mass.), Ed Markey (D-Mass.), Bernie Sanders (I-Vt.), Chris Murphy (D-Conn.), and Sherrod Brown (D-Ohio) are requesting information about potentially deceptive promotions of medical credit cards. The lawmakers sent a letter to Wells Fargo & Co. and Synchrony Financial regarding their credit card offerings intended to cover expensive health care services. “Patients – often under duress because of concerns about their medical care – are being pushed into and then locked into medical credit cards despite the availability of alternative payment options that might be more beneficial and offer lower interest rates,” the letter states. The lawmakers request a response from the lenders by January 12.

 

Stabenow Announces Decision to Not Seek Another Senate Term

Sen. Debbie Stabenow (D-Mich.) announced last week that she will not run for reelection in 2024. Stabenow currently serves as Chair of the Democratic Policy and Communications Committee and as chair of the Senate Agriculture Committee. She the most senior Democrat on the Senate Finance Committee after Chairman Wyden (D-Ore.). Stabenow was first elected to the House of Representatives in 1996 and became the first women to be elected to the Senate from the state of Michigan in 2000. Reps. Elissa Slotkin (D-Mich.) and Debbie Dingell (D-Mich.) are reportedly considering a bid for Stabenow’s Senate seat.

 

Boyle to Take Leave from W&M While Serving as Budget Ranking Member

Rep. Brendan Boyle (D-Pa.) will take a temporary leave of absence from the House Ways and Means Committee this congress, following his selection as ranking member of the Budget Committee. This arrangement is in keeping with that chosen by Sen. Chris Van Hollen (D-Md.), who served on Ways and Means Committee but was also chosen to lead Budget Committee Democrats during his time in the House of Representatives. Minority Leader Hakeem Jeffries (D-N.Y.) has approved Boyle’s decision.

 

Sen. Casey Announces Cancer Diagnosis, Expects Full Recovery

Sen. Bob Casey (D-Pa.) announced last week that he has been diagnosed with prostate cancer. He will undergo surgery in the “coming months.” Casey stated that he expects a full recovery and expressed his confidence that he will be able to continue to serve in the 118th congress with “minimal disruption.”