Agencies Prepare for Partial Shutdown as March 1 Deadline Approaches

Agencies Prepare for Partial Shutdown as March 1 Deadline Approaches-The House of Representatives will vote on four separate appropriations bills this week to avert a partial government shutdown as Congress’ first funding deadline approaches on March 1. House Speaker Mike Johnson (R-La.) acknowledged on a call with the GOP conference Friday night that another stopgap spending bill may be necessary to provide lawmakers with additional time to pass the Agriculture-Food and Drug Administration, Military Construction-Veterans Affairs, Energy-Water, and Transportation-Housing and Urban Development spending bills. House members are not scheduled to return to session until Wednesday. Senate Majority Leader Chuck Schumer (D-N.Y.) sent a letter to lawmakers on Sunday reporting that “intense discussions” continue. Although appropriators continue to work toward a compromise on the spending bills, many note that partisan policy riders are presenting hurdles. The federal government once again formally initiated the process of preparing for a partial shutdown, with the Office of Management and Budget instructing agencies to review and update their shutdown plans and providing templates for notifying employees of the status of appropriations. Lawmakers face a March 8 deadline for the remaining eight appropriations bills, including funding for the U.S. Department of Health and Human Services.

 

Leadership Announces New Bipartisan AI Task Force-House Speaker Mike Johnson (R-La.) and Minority Leader Hakeem Jeffries (D-N.Y.) have launched a new task force on artificial intelligence. The 24-member task force will be chaired by Rep. Jay Obernolte (R-Calif.) and co-chaired by Rep. Ted Lieu (D-Calif.). Membership includes several lawmakers active in the health care policy space, including Reps. Anna Eshoo (D-Calif.), Neal Dunn, MD (R-Fla.), Michelle Steel (R-Calif.), Don Beyer (D-Va.), Ami Bera, MD (D-Calif.), Bill Foster (D-Ill.), Rich McCormick, MD (R-Ga.), and Sara Jacobs (D-Calif.). The group plans to release a report outlining bipartisan proposals for regulating AI technology and spurring investment in AI later this year.

 

Coons, Tillis Spearhead Letters on March-In Rights, IP Protection-Sens. Chris Coons (D-Del.) and Thom Tillis (R-N.C.) are urging the Biden administration to reconsider its proposal to exercise march-in rights under the Bayh-Dole Act as a means to reduce the price of prescription drugs. The letter, which was signed by more than two dozen lawmakers, highlights the potential unintended consequences of including “reasonable pricing” as a factor in the draft framework for initiating the use of march-in rights. “Entrepreneurial startups and small companies across industries-from green technology and precision agriculture to advanced computing and semiconductors-would be subject to march-in petitions challenging their pricing decisions by rival businesses and even our foreign competitors and adversaries, who could use this tool to cast a cloud over the companies that drive our economy,” the lawmakers warn. They also outline the possible impact of the draft march-in framework on U.S. academic research institutions and efforts to revitalize American manufacturing and technological innovation.

 

The letter concerning the Bayh-Dole Act follows a letter sent by Sens. Coons and Tillis, along with Sens. Mazie Hirono (D-Hawaii) and James Lankford (R-Okla.), to National Security Adviser Jake Sullivan regarding the proposed global accord on pandemic prevention, preparedness, and response currently being negotiated by members of the World Health Organization. The lawmakers express concerns that the proposed agreement could undermine intellectual property (IP) laws “based on a faulty premise that IP rights impeded the global response to the COVID-19 crisis.” The letter asserts that many factors other than IP were responsible for barriers to treatment access, and that IP protection is “at the core of successful pandemic preparedness.”

 

Cassidy Releases White Paper on Health Data Privacy Protections-Senate Health, Education, Labor, and Pensions Committee Ranking Member Bill Cassidy (R-La.) released a new report last week outlining proposals to improve Americans’ health data privacy. The paper reviews the existing health privacy framework and discusses health data in the Health Insurance Portability and Accountability Act (HIPAA) “gray area” as well as data that falls outside of HIPAA. The white paper follows a request for information issued by Cassidy last year on how to enhance health data privacy protections covered under HIPAA as well as protections for new sources of data. Cassidy argues that Congress “needs to create guardrails around how health data not covered by HIPAA is shared to ensure interoperability does not sacrifice patient privacy” and should “create a more sustainable framework for future information sharing.”

 

Alabama Supreme Court Issues Ruling on Frozen Embryos-The Alabama Supreme Court ruled last week that couples who lost frozen embryos in an accident at a storage facility can sue under the state’s wrongful death law. The decision reverses a lower court ruling which dismissed the wrongful death claim on the grounds that the embryos were not a person or child. Since the decision, at least three of the state’s in vitro fertilization clinics have announced that they were pausing IVF services as they work to determine the legal implications of the ruling.

 

Congressional Retirements and Resignations-A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Butler (D), CA
Manchin (D), WV
HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Bishop (R), NC
Schiff (D), CA Lesko (R), AZ
Slotkin (D), MI Granger (R), TX
Allred (D), TX Buck (R), CO
Trone (D), MD Burgess (R), TX
Blunt Rochester (D), DE Wenstrup (R), OH
Napolitano (D), CA McHenry (R), NC
Wexton (D), VA McCarthy (R), CA (effective Dec. 31, 2023)
Kim, Andy (D), NJ Johnson (R), OH (effective Jan. 21, 2024)
Jackson, Jeff (D), NC Ferguson (R), GA
Sarbanes (D), MD Curtis (R), UT
Blumenauer (D), OR Luetkemeyer (R), MO
Kilmer (D), WA Lamborn (R), CO
Spanberger (D), VA Bucshon (R), IN
Kildee (D), MI Pence (R), IN
Phillips (D), MN Duncan (R), SC
Cardenas (D), CA Armstrong (R), ND
Eshoo (D), CA McMorris Rodgers (R), WA
Manning (D), NC Gallagher (R), WI
Higgins (D), NY (effective Feb. 2, 2024) Green (R), TN
Nickel (D), NC
Ruppersberger (D), MD
Sablan (D), MP

 

Upcoming Congressional Hearings and Markups

Senate Budget Committee hearing “No Rights to Speak of: The Economic Harms of Restricting Reproductive Freedom;” 10:00 a.m.; February 28

 

 

Senate Armed Services Subcommittee on Personnel hearing to receive testimony on traumatic brain injury and blast exposure care; 3:00 p.m.; February 28

 

House Energy and Commerce Subcommittee on Health hearing “Legislative Proposals to Support Patients with Rare Diseases;” 10:00 a.m.; February 29

 

 

Recently Introduced Health Legislation

H.R.7406-To amend the Public Health Service Act to authorize the Secretary of Health and Human Services to carry out a program of research, training, and investigation related to Down syndrome, and for other purposes. Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce

 

H.R.7405-To amend title 10, United States Code, to prohibit the exclusion of an individual from assignment to a medical personnel position of the Armed Forces on the basis of the amputation of the individual, and for other purposes. Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Armed Services

 

H.Res.1025-Expressing support for the designation of April 5, 2024, as “Barth Syndrome Awareness Day”; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

H.R.7418-To amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants; Sponsor: Kelly, Mike [Rep.-R-PA-16]; Committees: House – Ways and Means

 

Senate Passes Supplemental Appropriations Measure

Senate Passes Supplemental Appropriations Measure-The Senate passed a $95 billion bipartisan national security supplemental appropriations package last week including $60 billion in aid for Ukraine, $14 billion in aid for Israel, and $10 billion in humanitarian assistance to the Gaza Strip and Ukraine. The package also includes the FEND Off Fentanyl Act, which would provide $1.2 billion to curb fentanyl trafficking and allow for the sanctioning of fentanyl cartels. House Speaker Mike Johnson (R-La.) has stated that he will not bring the bill for consideration before the House of Representatives.

 

Lawmakers Consider Potential of Short and Long-Term Physician Fee Schedule Reform-Lawmakers are going on the record regarding the chances of a Medicare physician reimbursement fix this year. A 3.37% reduction to Medicare physician payments went into effect on January 1, 2024. Reps. Ami Bera (D-Calif.) and Robin Kelly (D-Ill.) told an American Medical Association conference last week that their current priority is at least partial reversal of the cut that took place at the beginning of this year. At the same event, Rep. Larry Bucshon (R-Ind.) stated that a doctor pay fix could be included in a government funding package next month. While there is bipartisan agreement that broader reforms to the Medicare Physician Fee Schedule (MPFS) are necessary, such work is not likely until 2025 given the slow-down in legislative activity during presidential election years. This effort will also be complicated by the retirement from Congress of several physician lawmakers and other champions of Medicare physician payment reform. In related news, Sens. Catherine Cortez Masto (D-Nev.), Marsha Blackburn (R-Tenn.), John Thune (R-S.D.), John Barrasso (R-Wyo.), Debbie Stabenow (D-Mich.), and Mark Warner (D-Va.) recently announced the formation of a working group to investigate and propose long-term reforms to the MPFS and make necessary updates to the Medicare Access and CHIP Reauthorization Act. The working group plans to reach out to stakeholders in the coming weeks to seek feedback and to begin developing policies that will address Medicare physician payment in the long-term.

 

Durbin, Braun Call on FDA to Address Rx Drug Promotion on Social Media-Sens. Dick Durbin (D-Ill.) and Mike Braun (R-Ind.) have sent a letter the Food and Drug Administration (FDA) calling on Commissioner Robert Califf to take action to address the “alarming proliferation of dangerous and misleading content promoting prescription drugs.” The lawmakers specifically request that the FDA modernize its draft guidance on prescription drug promotion, which has not been updated since 2014, to clarify that platforms like Instagram, Snapchat, X, and TikTok are subject to FDA regulation and requirements. They highlight the social media promotion of prescription drugs by telehealth companies as a perceived gap in the FDA’s jurisdiction. Durbin and Braun also argue that prescription drug promotion by social media influencers warrants particular attention. “The threats to children from misleading and unsubstantiated advertisements necessitate action, “The letter argues. “You have called health misinformation and disinformation a leading cause of death in the United States-and it is time the FDA addresses this challenge.”

 

E&C Leaders Ask GAO to Assess Risks of Selling Excess Laboratory Equipment-Republicans on the House Energy and Commerce Committee are calling for an investigation into how well the U.S. Department of Health and Human Services (HHS) and the Department of Agriculture manage the resale of laboratory equipment and protective gear. “The availability of both biological laboratory equipment and protective clothing on the commercial market provides access to materials needed to conduct legitimate scientific research, but also increases the chances this equipment could be used for malicious purposes, such as biological terrorism or warfare,” Committee Chair Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Brett Guthrie (R-Ky.), and Oversight Subcommittee Chair Morgan Griffith (R-Va.) write. The lawmakers request that the Government Accountability Office (GAO) examine the extent to which these items are resold or exported and the controls in place to limit the risk they are used to create biological weapons both within and outside the U.S.

 

Sanders Urges Strong Warning Labels to Combat Diabetes Epidemic and Obesity-Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) has sent a letter to the FDA urging Commissioner Califf to require the food and beverage industry to place strong warning labels on products high in sugar, salt, and saturated fats. Sanders points out the direct relationship between the nation’s diabetes epidemic and obesity crisis, and argues that the FDA “can and must do more to ensure that Americans, especially children, teens, and their parents understand the health risks associated with the consumption of these unhealthy and ultra-processed foods.” Sanders’ letter notes his plans for the HELP Committee to hold a hearing in the near future to consider what the FDA can do to ensure that the food and beverages Americans consume are not harming them.

 

Lawmakers Express Concerns About Private Equity in Health Care-The Massachusetts congressional delegation has written to Ceberus Capital Management expressing concerns about the private equity firm’s role in the finances of Steward Health Care-owned hospitals across the state. “We have long been concerned about the nefarious role of private equity in our economy. Ownership by private equity investors increases health care costs and reduces quality of care, and private equity firms have played a role in the collapse of hospitals around the country, hurting communities and the health care workers and other staff that serve them,” the letter argues. “The dire threat of Steward’s collapse appears to be a textbook example of the grave risks posed by a private equity takeover of the health care system.”

 

HHS, FTC Issue RFI on Generic Drug Shortages-HHS and the Federal Trade Commission (FTC) have issued a request for information (RFI) on generic drug shortages and the impact of group purchasing organizations (GPOs) and drug wholesalers on access to generic pharmaceuticals. The agencies are requesting public input on:

  • Whether and to what extent manufacturers, GPOs, and drug wholesalers are complying with their legal obligations under Section 3 of the Clayton Act and the Robinson-Patman Act.
  • Whether and to what extent the available protections for GPOs under the Federal Anti-Kickback Statute affect market concentration and contracting practices by GPOs, as well as drug shortages.
  • Whether and to what extent market concentration among GPOs and drug wholesalers has impacted smaller health care providers and rural hospitals.
  • Whether and to what extent concentration among GPOs and drug wholesalers has disincentivized suppliers from competing in generic drug markets.
  • The impact of the prevailing GPO compensation model, which may rely on rebates, chargebacks, and administrative fees from manufacturers and suppliers in exchange for favorable treatment, on generic manufacturers and other suppliers.

The RFI is a part of the administration’s effort to promote competition in pharmaceutical markets and ensure access to high-quality, affordable care. This latest announcement notes another forthcoming joint RFI from the FTC, HHS, and Department of Justice seeking input on how private equity and other corporations’ control of health care is impacting Americans.

 

HHS OIG Releases Telehealth Report-The HHS Office of the Inspector General (OIG) released a report last week finding that health care providers largely complied with Medicare requirements when billing for evaluation and management (E/M) services provided via telehealth during the first nine months of the COVID-19 pandemic. The agency found that for 105 of the 110 sampled E/M services provided via telehealth, providers complied with Medicare requirements; the Medicare program paid $446 for the five sampled E/M services for which providers did not document or insufficiently documented the services. Investigators determined that unallowable payments identified resulted primarily from clerical errors or the inability to access records.

 

FDA Approves First Cell Therapy for Solid Tumors-The FDA has approved Iovance Biotherapeutics’ Amtagvi to treat advanced melanoma that either cannot be removed from the body or has spread throughout the body and was previously treated with other therapies. It is the first cell therapy to be approved for the treatment of solid tumors. Iovance is currently working to complete a confirmatory trial to ensure Amtagvi has a clinical benefit to cancer patients.

 

Congressional Retirements and Resignations-Rep. Matt Rosendale (R-Mt.) has dropped his bid to unseat Sen. Jon Tester (D-Mont.) less than a week after launching his campaign for the Senate. Rosendale has not yet decided whether he will run for reelection to the House of Representatives. The filing deadline for Montana is March 11.

 

Rep. Mark Green (R-Tenn.) has announced his decision to retire at the end of the year. Green was first elected to Congress in 2018. He currently serves as the chair of the House Homeland Security Committee.

 

Former Rep. Tom Suozzi (D) defeated Republican candidate Mazi Pilip to succeed ousted Rep. George Santos (R-N.Y.) in the House of Representatives. His victory flips the state’s third congressional district back to Democrats and further narrows the GOP’s majority in the House.

 

Rep. James Clyburn (D-S.C.) has stepped down from his role as assistant Democratic leader, a position he has held for just over a year. He previously served as the House Majority Whip. His decision follows similar moves by former House Speaker Nancy Pelosi (D-Calif.) and former Majority Leader Steny Hoyer (D-Md.) to step down from their respective leadership roles after the 2022 election. Rep. Joe Neguse (D-Colo.), chair of the Democratic Policy and Communications Committee, plans to run for assistant leader, according to two Democratic leadership aides.

 

A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Butler (D), CA
Manchin (D), WV
HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Bishop (R), NC
Schiff (D), CA Lesko (R), AZ
Slotkin (D), MI Granger (R), TX
Allred (D), TX Buck (R), CO
Trone (D), MD Burgess (R), TX
Blunt Rochester (D), DE Wenstrup (R), OH
Napolitano (D), CA McHenry (R), NC
Wexton (D), VA McCarthy (R), CA (effective Dec. 31, 2023)
Kim, Andy (D), NJ Johnson (R), OH (effective Jan. 21, 2024)
Jackson, Jeff (D), NC Ferguson (R), GA
Sarbanes (D), MD Curtis (R), UT
Blumenauer (D), OR Luetkemeyer (R), MO
Kilmer (D), WA Lamborn (R), CO
Spanberger (D), VA Bucshon (R), IN
Kildee (D), MI Pence (R), IN
Phillips (D), MN Duncan (R), SC
Cardenas (D), CA Armstrong (R), ND
Eshoo (D), CA McMorris Rodgers (R), WA
Manning (D), NC Gallagher (R), WI
Higgins (D), NY (effective Feb. 2, 2024) Green (R), TN
Nickel (D), NC
Ruppersberger (D), MD
Sablan (D), MP

 

Recently Introduced Health Legislation

H.R.7317-To amend the Public Health Service Act to authorize the Secretary of Health and Human Services to award grants to nursing homes, assisted living facilities, and other long-term care facilities to improve their preparedness for power outages. Sponsor: Wilson, Frederica S. [Rep.-D-FL-24]; Committees: House – Energy and Commerce

 

H.R.7312-To provide for requirements for electronic-prescribing for controlled substances under group health plans and group and individual health insurance coverage. Sponsor: Kuster, Ann M. [Rep.-D-NH-2]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means; Judiciary

 

H.R.7307-To amend the Public Health Service Act to establish a grant program to expand the number of allied health professionals in underserved communities and rural areas, and for other purposes. Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce

 

S.3797-A bill to amend the Indian Health Care Improvement Act to address liability for payment of charges or costs associated with provision of purchased/referred care services, and for other purposes; Sponsor: Rounds, Mike [Sen.-R-SD]; Committees: Senate-Indian Affairs

 

S.3799-A bill to require the Secretary of Health and Human Services to evaluate how the frequency of summary notices provided to patients can be increased, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate-Finance

 

S.3800-A bill to increase the penalties for health care fraud, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate-Judiciary

 

S.Res.560-A resolution designating February 2024 as “American Heart Month”; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

H.R.7327-To amend title XIX of the Social Security Act to ensure adequate consideration of payment rates for multimission hospitals under the Medicaid program, and for other purposes; Sponsor: DeGette, Diana [Rep.-D-CO-1]; Committees: House – Energy and Commerce

 

H.R.7346-To amend the Public Health Service Act to provide for the continued implementation of the Climate and Health program by the Centers for Disease Control and Prevention; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce

 

H.R.7347-To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs; Sponsor: Van Orden, Derrick [Rep.-R-WI-3]; Committees: House – Veterans’ Affairs

 

H.R.7354-To establish an Interagency Task Force to examine the conditions and experiences of Black women and girls in education, economic development, healthcare, labor and employment, housing, justice and civil rights, to promote community-based methods for mitigating and addressing harm and ensuring accountability, and to study societal effects on Black women and girls, and for other purposes; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Judiciary; Education and the Workforce; Energy and Commerce; Financial Services

 

H.R.7368-To amend title XVIII of the Social Security Act to provide for the application of Medicare secondary payer rules to certain workers’ compensation settlement agreements and qualified Medicare set-aside provisions; Sponsor: Carey, Mike [Rep.-R-OH-15]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.7373-To direct the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to include alpha-gal syndrome on the list of nationally notifiable diseases; Sponsor: Garbarino, Andrew R. [Rep.-R-NY-2]; Committees: House – Energy and Commerce

 

H.R.7379-To amend title XXX of the Public Health Service Act to establish standards and protocols to improve patient matching; Sponsor: Kelly, Mike [Rep.-R-PA-16]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7381-To direct the Director of the National Institutes of Health to establish a grant program to facilitate research regarding the use of generative artificial intelligence in health care, and for other purposes; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Energy and Commerce

 

H.R.7383-To amend the Federal Food, Drug, and Cosmetic Act to set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce

 

H.R.7384-To amend the Federal Food, Drug, and Cosmetic Act to extend the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases; Sponsor: McCaul, Michael T. [Rep.-R-TX-10]; Committees: House – Energy and Commerce

 

H.R.7397-To amend title XVIII of the Social Security Act to establish a definition of essential health system in statute; Sponsor: Trahan, Lori [Rep.-D-MA-3]; Committees: House – Ways and Means; Energy and Commerce

House Passes Bill to Expand Prohibition on QALYs

House Passes Bill to Expand Prohibition on QALYs-The House of Representatives passed legislation (H.R. 485) along party lines last week to prohibit the use of quality-adjusted life years (QALYs) and similar metrics in Medicaid and other federal health programs. While supporters of the Protecting Health Care for All Patients Act argue that QALYs discriminate against people with disabilities, congressional Democrats have voiced concerns that the bill’s language is too vague and could impact a broader set of comparative effectiveness analysis used in federal drug price negotiations. Republicans have countered that the legislation mirrors language in the Affordable Care Act, which banned the use of QALYs to determine coverage in the Medicare program.

 

Oversight Panel Advances PBM Reform Bill-The House Oversight and Accountability Committee advanced the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283) last week. The bipartisan legislation introduced by Reps. Mariannette Miller-Meeks (R-Iowa) and Nanette Diaz Barragan (D-Calif.) would prohibit pharmacy benefit managers (PBMs) from tying fees or other types of remuneration to the price of a medicine and instead require fees to be structured as a flat fee based on the fair market value of PBM services. Additionally, the DRUG Act would ban the practices of spread pricing and patient steering, and prohibit PBMs from paying affiliated pharmacies more than independent community pharmacies for the same services. The bill was favorably reported by a 29-11 vote.

 

Budget Committee Marks Up Preventive Health Savings Act-The House Budget Committee unanimously advanced the bipartisan Preventive Health Savings Act (H.R. 766) last week in a 30-0 vote. The bill, which was introduced by Reps. Michael Burgess (R-Texas) and Diana DeGette (D-Colo.), directs the Congressional Budget Office (CBO) to more accurately reflect the long term and cost-saving potential of preventive health care initiatives. It also encourages the use of data-informed preventive health measures, and instructs the agency to extend its analysis from the existing 10-year budget window to a 30-year budget window to more sufficiently reflect the potential impact of preventive health policies.

 

Democrats Urge White House to Finalize March-In Rights Guidance-A group of more than 70 congressional Democrats sent a letter to Biden administration officials last week in support of the White House’s proposal to exercise march-in rights to ensure reasonable prices for taxpayer-funded inventions. The lawmakers offer comments for how the administration’s “Interagency Guidance Framework for Considering the Exercise of March-In Rights” might be strengthened, and urge the administration to finalize the draft framework without delay. “Reining in out-of-control prescription drug prices is one of the most pressing challenges facing the United States, and taxpayers are investing more than ever in biomedical research, sometimes funding 80 to 100 percent of the cost of developing a new medical product,” the letter states. “While we recognize the important role of the private sector in research and development and support the ability to make a reasonable profit, industry interests should not outweigh meeting health and safety needs for all consumers and providing accountability to taxpayers.” In addition to the letter from congressional Democrats, more than 500 comments were received from the public during the notice and comment period for the proposal, which ended on February 6.

 

E&C Subpoenas NIH for Documents Related to Sexual Harassment Investigation-The House Energy and Commerce Committee is subpoenaing the National Institutes of Health (NIH) for information related to allegations of sexual harassment within the agency and its grantees. An investigation led by Chair Cathy McMorris Rodgers (R-Wash.) found at least 300 cases of harassment since 2018. “As the largest public funder of biomedical research, the NIH is uniquely positioned to transform the culture of science to prevent sexual harassment and mitigate its detrimental impacts,” Chair Rodgers stated. “Unfortunately, the NIH has failed to comply adequately with requests for information and documents related to its handling of sexual harassment complaints.”

 

CBO Releases Latest Deficit Projections-The Congressional Budget Office (CBO) has released its latest Budget and Economic Outlook, covering the period of 2024 to 2034. CBO estimates that the federal budget deficit will grow by $1 trillion over the next decade, largely driven by federal spending on entitlement programs like Medicare, Medicaid, and Social Security. The agency projects that the deficit will grow from 5.6% of gross domestic product in 2024 to 6.1% in 2034. CBO notes that, since the Great Depression, deficits have exceeded that level only during and shortly after World War II, the 2007-2009 financial crisis, and the coronavirus pandemic.

 

Congressional Retirements and Resignations-After two decades in Congress, Chairwoman of the House Energy and Commerce Committee Cathy McMorris Rodgers (R-Wash.) announced that she will not run for reelection this year. McMorris Rodgers is a former Republican Conference Vice Chair. During her time as Energy and Commerce Republican leader, she helped advance the latest package of Food and Drug Administration user fee agreement reauthorizations and authored transparency legislation. Rep. Michael Burgess (R-Texas), the second-most-senior Republican on the Committee, previously announced his plan to retire this year. The next most senior Republican, Rep. Bob Latta (R-Ohio), is expected to run for the top seat on the panel. Health Subcommittee Chairman Brett Guthrie (R-Ky.) has also confirmed that he will run to lead the committee.

 

Rep. Mike Gallagher (R-Wisc.), who was first elected to the House in 2017, announced that he will not seek reelection. Before joining the House of Representatives, Gallagher served in the Marine Corps, staffed the Senate Foreign Relations Committee, and worked in the private sector. Currently, he chairs the House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party, and the House Armed Services Subcommittee on Cyber, Information Technologies, and Innovation. He also serves on the Permanent Select Committee on Intelligence.

 

Rep. Matt Rosendale (R-Mont.) has announced his bid for the GOP nomination to challenge Sen. Jon Tester (D-Mont.) for his seat in the upper chamber. Rosendale has served in the House of Representatives since 2021 and currently sits on the Veterans Affairs Committee. He will face Tim Sheehy, a retired Navy SEAL in the primary.

 

Rep. Victoria Spartz (R-Ind.) has reversed her decision to retire from Congress and will run for reelection this November.

 

Former Maryland Governor Larry Hogan (R) announced that he plans to run for the Maryland Senate seat currently held by retiring Senator Ben Cardin (D).

 

A running list of members of Congress who are retiring, seeking other office, or have vacated their office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Feinstein (D), CA
Manchin (D), WV
HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Bishop (R), NC
Schiff (D), CA Lesko (R), AZ
Slotkin (D), MI Granger (R), TX
Allred (D), TX Buck (R), CO
Trone (D), MD Burgess (R), TX
Blunt Rochester (D), DE Santos (R), NY (effective Dec. 1, 2023)
Napolitano (D), CA Wenstrup (R), OH
Wexton (D), VA McHenry (R), NC
Kim, Andy (D), NJ McCarthy (R), CA (effective Dec. 31, 2023)
Jackson, Jeff (D), NC Johnson, Bill (R), OH (effective Jan. 21, 2024)
Sarbanes (D), MD Ferguson (R), GA
Blumenauer (D), OR Curtis (R), UT
Kilmer (D), WA Luetkemeyer (R), MO
Spanberger (D), VA Lamborn (R), CO
Kildee (D), MI Bucshon (R), IN
Phillips (D), MN Pence (R), IN
Cardenas (D), CA Duncan (R), SC
Eshoo (D), CA Armstrong (R), ND
Manning (D), NC McMorris Rodgers (R), WA
Higgins (D), NY (effective Feb. 2, 2024) Rosendale (R), MT
Nickel (D), NC Mike Gallagher (R), WI
Ruppersberger (D), MD
Sablan (D), MP

 

Upcoming Congressional Hearings and Markups

 

House Select Committee on the Chinese Communist Party field hearing “Growing Stakes: The Bioeconomy and American National Security;” 8:30 a.m.; February 13

 

House Energy and Commerce Subcommittee on Health legislative hearing “Legislative Proposals to Support Patients and Caregivers;” 10:00 a.m.; February 14

 

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: Can the Oracle Pharmacy Software Be Made Safe and Effective?;” 8:00 a.m.; February 15

 

House Veterans’ Affairs Subcommittee on Health hearing “Artificial Intelligence at VA: Exploring its Current State and Future Possibilities;” 10:00 a.m.; February 15

 

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Assessing America’s Vaccine Safety Systems, Part 1;” 10:00 a.m.; February 15

 

Recently Introduced Health Legislation

 

H.R.7218-To amend title III of the Public Health Service Act to extend the program for promotion of public health knowledge and awareness of Alzheimer’s disease and related dementias, and for other purposes; Sponsor: Guthrie, Brett [Rep.-R-KY-2]; Committees: House – Energy and Commerce

 

H.R.7222-To amend the Internal Revenue Code of 1986 to allow expenses for parents to be taken into account as medical expenses, and for other purposes; Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Ways and Means

 

H.R.7224-To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program; Sponsor: Cohen, Steve [Rep.-D-TN-9]; Committees: House – Energy and Commerce

 

H.R.7226-To require research with respect to fentanyl and xylazine test strips, to authorize the use of grant funds for such test strips, and for other purposes; Sponsor: Crockett, Jasmine [Rep.-D-TX-30]; Committees: House – Energy and Commerce

 

H.R.7239-To amend the Controlled Substances Act to enhance the penalties applicable with respect to certain violations involving the use of interactive computer service to distribute a controlled substance, and for other purposes; Sponsor: Pfluger, August [Rep.-R-TX-11]; Committees: House – Judiciary; Energy and Commerce

 

S.3733-A bill to require the Secretary of Health and Human Services to conduct a national, evidence-based education campaign to increase public and health care provider awareness regarding the potential risks and benefits of human cell and tissue products transplants, and for other purposes; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3740-A bill 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: Cornyn, John [Sen.-R-TX]; Committees: Senate-Judiciary

 

S.3741-A bill to prohibit the Secretary of Health and Human Services from restricting funding for pregnancy centers; Sponsor: Scott, Tim [Sen.-R-SC]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.1000-Expressing support for the designation of February 4, 2024, as “National Cancer Prevention Day”; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

 

H.R.7248-To amend the Federal Food, Drug, and Cosmetic Act to establish a process for the qualification of nonclinical testing methods to reduce and replace the use of animals in nonclinical research, improve the predictivity of nonclinical testing methods, and reduce development time for a biological product or other drug, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.7254-To direct the Administrator of the Centers for Medicare and Medicaid to clarify that fully implanted active middle ear hearing devices are prosthetics and are not subject to the hearing aid coverage exclusion under the Medicare program; Sponsor: Fischbach, Michelle [Rep.-R-MN-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7258-To amend the Public Health Service Act to provide community-based training opportunities for medical students in rural areas and medically underserved communities, and for other purposes; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House – Energy and Commerce

 

H.Res.1004-Expressing support for the designation of February 4 through February 10, 2024, as “National Burn Awareness Week”; Sponsor: Thompson, Mike [Rep.-D-CA-4]; Committees: House – Oversight and Accountability

 

H.R.7265-To authorize the Secretary of Health and Human Services to award grants to establish or expand programs to implement evidence-aligned practices in health care settings for the purpose of reducing the suicide rates of covered individuals, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.7266-To amend the Public Health Service Act to authorize grants to support schools of nursing in increasing the number of nursing students and faculty and in program enhancement and infrastructure modernization, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House – Energy and Commerce

 

H.R.7267-To amend title XIX of the Social Security Act to provide a temporary higher Federal medical assistance percentage for Federal expenditures under the Medicaid program that are associated with the cost of compliance with certain Federal regulations with respect to services furnished in certain intermediate care facilities or home and community-based services furnished to individuals with intellectual and developmental disabilities; Sponsor: Tonko, Paul [Rep.-D-NY-20]; Committees: House – Energy and Commerce

 

H.R.7268-To amend the Public Health Service Act to authorize the Secretary of Health and Human Services to carry out a program of research, training, and investigation related to Down syndrome, and for other purposes; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce

 

H.R.7274-To amend title XVIII of the Social Security Act to provide for outreach and education to Medicare beneficiaries to simplify access to information for family caregivers through 1-800-MEDICARE, and for other purposes; Sponsor: Carey, Mike [Rep.-R-OH-15]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.7279-To amend title XVIII of the Social Security Act to reduce the administrative burden on physicians and physical and occupational therapists, with respect to plan of care certification and recertification requirements; Sponsor: Davis, Donald G. [Rep.-D-NC-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7282-To amend title XIX of the Social Security Act to provide States with an option to provide medical assistance to individuals between the ages of 22 and 64 for inpatient services to treat substance use disorders at certain facilities, and for other purposes; Sponsor: Foster, Bill [Rep.-D-IL-11]; Committees: House – Energy and Commerce

 

H.R.7283-To direct the Comptroller General of the United States to evaluate and report on the inpatient and outpatient treatment capacity, availability, and needs of the United States; Sponsor: Foster, Bill [Rep.-D-IL-11]; Committees: House – Energy and Commerce; Natural Resources

 

H.R.7292-To amend title XI of the Social Security Act to lower barriers to increase patient access to health care; Sponsor: Moore, Blake D. [Rep.-R-UT-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7300-To amend title V of the Social Security Act to extend funding for the family-to-family health information centers; Sponsor: Sherrill, Mikie [Rep.-D-NJ-11]; Committees: House – Energy and Commerce

 

H.R.7301-To amend the Protecting Access to Medicare Act of 2014 to clarify the meaning of psychiatric rehabilitation services under demonstration programs to improve community mental health services, and for other purposes; Sponsor: Torres, Ritchie [Rep.-D-NY-15]; Committees: House – Energy and Commerce

 

H.R.7305-To direct the Secretary of Defense to provide to the Committees on Armed Services of the Senate and House of Representatives a report and briefing on anomalous health incidents affecting members of the Armed Forces and civilian employees of the Department of Defense; Sponsor: Wenstrup, Brad R. [Rep.-R-OH-2]; Committees: House – Armed Services

 

S.3744-A bill to amend title XI of the Social Security Act to lower barriers to increase patient access to health care; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate-Finance

 

S.3756-A bill to establish a new pilot program that would test coverage of outpatient observation services furnished outside a hospital under the Acute Hospital Care at Home initiative; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate-Finance

 

S.3757-A bill to reauthorize the congenital heart disease research, surveillance, and awareness program of the Centers for Disease Control and Prevention, and for other purposes; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3765-A bill to amend the Public Health Service Act to reauthorize the Emergency Medical Services for Children program; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3766-A bill to amend title XVIII of the Social Security Act to provide for outreach and education to Medicare beneficiaries to simplify access to information for family caregivers through 1-800-MEDICARE, and for other purposes; Sponsor: Tillis, Thomas [Sen.-R-NC]; Committees: Senate-Finance

 

Government Funding Update

Government Funding Update-The Labor-Health and Human Services (HHS)-Education appropriations bill will face cuts in fiscal year (FY) 2024 under an agreement reached by bicameral appropriations leadership on spending totals for the 12 annual government funding bills. According to Senate Labor-HHS-Education Subcommittee Chair Tammy Baldwin (D-Wis.), the funding will be less than both FY2023 levels ($209.9 billion in base discretionary funding plus $4.2 billion in emergency funds) and the Senate’s FY 2024 bill, which included $224.4 billion in discretionary funding. While the funding allocations are not yet publicly available, House Agriculture-Food and Drug Administration (FDA) Subcommittee Ranking Member Sanford Bishop (D-Ga.) has confirmed that the Agriculture-FDA bill will see a bump in funding. Lawmakers have less than one month to negotiate details of the spending bills, as current funding for federal agencies is set to expire on March 1 for some agencies, including the FDA, and March 8 for the remainder, including HHS. Congress faces an effective April 30 deadline to pass the FY 2024 appropriations bills due to a provision in the most recent debt ceiling law that would impose an automatic spending cut on all discretionary funding should a continuing resolution still be in place at that time. In related news, the White House Office of Management and Budget has confirmed that the President will send Congress his FY 2025 budget proposal on March 11, just days after his March 7 State of the Union address and the FY 2024 funding deadlines.

 

The Senate will vote this week on $118 billion border deal released on Sunday. The agreement includes $62 billion in aid for Ukraine, $14 billion in aid for Israel, and $10 billion in humanitarian assistance to the Gaza Strip and Ukraine. It also includes the Fentanyl Eradication and Narcotics Deterrence (FEND) Off Fentanyl Act. Majority Leader Chuck Schumer (D-N.Y.) plans to hold a procedural vote on the package Wednesday, though it remains unclear if it has the necessary 60 votes to advance.

 

CMS Makes First Offers in Drug Price Negotiation Program-Last week, the Centers for Medicare and Medicaid Services (CMS) sent its initial price offers for the 10 products selected for the first round of Medicare prescription drug price negotiations to the affected pharmaceutical manufacturers. The companies have until March 2 to accept the offer or make a counteroffer, and each company will be able to meet with CMS three times during the negotiation process. The administration will publish final prices by September 1. CMS has not released how much the initial price offers, which are not made public, would generate in savings.

 

Senate Finance Advances ASPE Nominee-The Senate Finance Committee advanced the nomination of Rebecca Lee Haffajee, JD, PhD, MPH to serve as the U.S. Department of Health and Human Services Assistant Secretary for Planning and Evaluation (ASPE) last week in a 14-13 party line vote. Haffajee has served in this role in an acting capacity since 2021. Her nomination will now be sent to the full Senate for consideration. Prior to joining the administration, Haffajee worked as a policy researcher at the RAND Corporation and an assistant professor at the University of Michigan School of Public Health.

 

 

Baldwin Calls for Increased Competition in Asthma-Inhaler Market-Sen. Tammy Baldwin (D-Wis.) has written to the nation’s four largest asthma inhaler manufacturers regarding their use of the Food and Drug Administration’s (FDA) Orange Book to delay the entrance of generic drug products to the market. The letters from Baldwin to AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Teva urge the companies to remove improperly listed patents from the agency’s database of patent and exclusivity information for FDA-approved drugs. Her letters highlight that despite warnings from the Federal Trade Commission challenging more than 100 asthma inhaler patents listed in the Orange Book as inaccurate or improper, the companies have not yet removed the patents.

 

Senate Dems Urge DEA to Deschedule Marijuana-Twelve Senate Democrats, including Majority Leader Chuck Schumer (D-N.Y.), have sent a letter to Attorney General Merrick Garland and Drug Enforcement Administration (DEA) leader Anne Milgram urging the administration to ease cannabis restrictions. The U.S. Department of Health and Human Services recommended in August that the DEA reschedule marijuana from Schedule I to Schedule III, and the agency’s review of the recommendation is ongoing. The letter, led by Elizabeth Warren (D-Mass.) and John Fetterman (D-Pa.), urges the DEA to “reach the right conclusion” and deschedule marijuana from the Controlled Substances Act altogether “consistent with the clear scientific and public health rationale for removing marijuana from Schedule I, and with the imperative to relieve the burden of current federal marijuana policy on ordinary people and small businesses.”

 

Lawmakers File Brief in Mifepristone Case-A group of 50 senators and 213 members of the House of Representatives have filed a brief in support of the Biden administration ahead of the Supreme Court’s consideration of Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine. The case will determine whether the Supreme Court should stay the U.S. District Court for the Northern District of Texas’s order blocking the FDA’s approval of mifepristone. The lawmakers argue that the “perils of this unwarranted judicial intervention into science-based determinations can hardly be overstated.” The Supreme Court is scheduled to hear arguments in the case on March 26.

 

HHS Finalizes OUD Treatment Rule-The U.S. Department of Health and Human Services (HHS) has made permanent certain COVID-era flexibilities impacting the prescription of buprenorphine. The final rule, which applies to certified opioid treatment programs, will allow the opioid use disorder (OUD) treatment to be prescribed via telehealth, including audio-only visits, without an initiating in-person visit with the prescriber. The regulation also allows providers more flexibility around the provision of unsupervised methadone doses.

 

Congressional Retirements and Resignations-A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Feinstein (D), CA
Manchin (D), WV
HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Spartz (R), IN
Schiff (D), CA Bishop (R), NC
Slotkin (D), MI Lesko (R), AZ
Allred (D), TX Granger (R), TX
Trone (D), MD Buck (R), CO
Blunt Rochester (D), DE Burgess (R), TX
Napolitano (D), CA Santos (R), NY (effective Dec. 1, 2023)
Wexton (D), VA Wenstrup (R), OH
Kim, Andy (D), NJ McHenry (R), NC
Jackson, Jeff (D), NC McCarthy (R), CA (effective Dec. 31, 2023)
Sarbanes (D), MD Johnson, Bill (R), OH (effective Jan. 21, 2024)
Blumenauer (D), OR Ferguson (R), GA
Kilmer (D), WA Curtis (R), UT
Spanberger (D), VA Luetkemeyer (R), MO
Kildee (D), MI Lamborn (R), CO
Phillips (D), MN Bucshon (R), IN
Cardenas (D), CA Pence (R), IN
Eshoo (D), CA Duncan (R), SC
Manning (D), NC Armstrong (R), ND
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC
Ruppersberger (D), MD
Sablan (D), MP

 

Upcoming Congressional Hearings and Markups

House Rules Committee meeting to report a Rule for H.R. 485, Protecting Health Care for All Patients Act; 4:00 p.m.; February 5

 

House Budget Committee markup of H.R. 766, Preventive Health Savings Act; H.R. 7032, Congressional Budget Office Data Sharing Act; H.R. 5301, Eliminate Useless Reports Act; 10:00 a.m.; February 6

 

House Ways and Means Committee hearing “Examining Chronic Drug Shortages in the United States;” 10:00 a.m.; February 6

 

House Oversight and Accountability Committee markup to consider H.R. 6283, Delinking Revenue from Unfair Gouging (DRUG) Act, and other legislation; 10:00 a.m.; February 6

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Protecting American Health Security: Oversight of Shortcomings in the FDA’s Foreign Drug Inspection Program;” 10:30 a.m.; February 6

 

Senate Health, Education, Labor, and Pensions Committee hearing “Why Does the United States Pay, by Far, the Highest Prices in the World for Prescription Drugs?;” 10:00 a.m.; February 8

 

Senate Finance Committee hearing “Artificial Intelligence and Health Care: Promise and Pitfalls;” 10:00 a.m.; February 8

 

Recently Introduced Health Legislation

H.Res.979-Expressing the sense of the House of Representatives that public health authorities and tobacco control advocates should encourage American innovation and embrace harm reduction as part of the comprehensive United States approach to tobacco control; Sponsor: Reschenthaler, Guy [Rep.-R-PA-14]; Committees: House – Energy and Commerce; Foreign Affairs

 

H.R.7108-To support States and high-need local educational agencies in increasing the number of mental health services providers in schools; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Education and the Workforce

 

H.R.7119-To amend titles XVIII and XIX of the Social Security Act to prohibit skilled nursing facilities and nursing facilities from using pre-dispute arbitration agreements with respect to residents of those facilities under the Medicare and Medicaid programs, and for other purposes; Sponsor: Sanchez, Linda T. [Rep.-D-CA-38]; Committees: House – Ways and Means; Energy and Commerce

 

S.3679-A bill to reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3680-A bill to amend the Internal Revenue Code of 1986 to enhance the paid family and medical leave credit, and for other purposes; Sponsor: Fischer, Deb [Sen.-R-NE]; Committees: Senate-Finance

 

S.3685-A bill to amend the Family and Medical Leave Act of 1993 to permit leave for bone marrow or blood stem cell donation, and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3691-A bill to amend title XVIII of the Social Security Act to provide for the application of a cost-of-living adjustment to the non-labor related portion for hospital outpatient department services furnished in Alaska and Hawaii; Sponsor: Sullivan, Dan [Sen.-R-AK]; Committees: Senate-Finance

 

H.Res.984-Expressing support for the designation of January 30, 2024, as CTE (chronic traumatic encephalopathy) and RHI (repeated head impacts) Awareness Day; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Energy and Commerce

 

H.R.7136-To require the Secretary of Veterans Affairs to establish a comprehensive standard for timing between referrals and appointments for care from the Department of Veterans Affairs and to submit a report with respect to that standard, and for other purposes; Sponsor: Franklin, C. Scott [Rep.-R-FL-18]; Committees: House – Veterans’ Affairs

 

H.R.7140-To amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to require group health plans and health insurance issuers offering group or individual health insurance coverage to disclose the percentage of in-network participation for certain provider types, and for other purposes; Sponsor: Horsford, Steven [Rep.-D-NV-4]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.7141-To amend titles XIX and XXI of the Social Security Act and title XXVII of the Public Health Service Act to require no-cost coverage of human milk fortifier; Sponsor: McGarvey, Morgan [Rep.-D-KY-3]; Committees: House – Energy and Commerce

 

H.R.7142-To amend title XVIII of the Social Security Act to ensure appropriate access to non-opioid pain management drugs under part D of the Medicare program; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7147-To amend title XI of the Social Security Act to establish a pilot program for testing the use of a predictive risk-scoring algorithm to provide oversight of payments for durable medical equipment and clinical diagnostic laboratory tests under the Medicare program; Sponsor: Schweikert, David [Rep.-R-AZ-1]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7148-To amend title XVIII of the Social Security Act to provide for eligibility for coverage of home health services under the Medicare Program on the basis of a need for occupational therapy; Sponsor: Smucker, Lloyd [Rep.-R-PA-11]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.7149-To amend title XI of the Social Security Act to require the Center for Medicare and Medicaid Innovation to test a model to improve access to specialty health services for certain Medicare and Medicaid beneficiaries; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7153-To reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Energy and Commerce

 

S.3700-A bill to permit nurse practitioners and physician assistants to furnish necessary services, appliances, and supplies to individuals receiving medical benefits for illnesses; Sponsor: Hickenlooper, John W. [Sen.-D-CO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3701-A bill to establish education partnership programs between public schools and public health agencies to prevent the misuse and overdose of synthetic opioids by youth, and for other purposes; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3713-A bill to prohibit the Federal Government from conducting, funding, approving, or otherwise supporting any research involving human fetal tissue that is obtained pursuant to an induced abortion, and to prohibit the solicitation or knowing acquisition, receipt, or acceptance of a donation of such tissue; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Con.Res.87-Recognizing the need for research, education, and policy development regarding high-potency marijuana; Sponsor: Sessions, Pete [Rep.-R-TX-17]; Committees: House – Energy and Commerce

 

H.R.7155-To provide for the establishment, within the Food and Drug Administration, of an Abraham Accords Bureau to promote and facilitate cooperation between the Food and Drug Administration and entities in Abraham Accords countries wishing to work with the agency in order to develop and sell products in the United States, and for other purposes; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce

 

H.R.7161-To require States to report information on Medicaid payments to abortion providers; Sponsor: Banks, Jim [Rep.-R-IN-3]; Committees: House – Energy and Commerce

 

H.R.7164-To advance population research for chronic pain; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Energy and Commerce

 

H.R.7174-To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program; Sponsor: McCormick, Richard [Rep.-R-GA-6]; Committees: House – Energy and Commerce; Ways and Means

 

S.Con.Res.27-A concurrent resolution recognizing the need for research, education, and policy development regarding high-potency marijuana; Sponsor: Ricketts, Pete [Sen.-R-NE]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3722-A bill to require a report on access to maternal health care within the military health system, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Armed Services

 

S.3725-A bill to amend the Toxic Substances Control Act to codify a Federal cause of action and a type of remedy available for individuals significantly exposed to per- and polyfluoroalkyl substances, to encourage research and accountability for irresponsible discharge of those substances, and for other purposes; Sponsor: Gillibrand, Kirsten E. [Sen.-D-NY]; Committees: Senate – Environment and Public Works

 

H.Res.992-Recognizing February 4, 2024, as “World Cancer Day”, and its theme “Close the Care Gap”, to raise awareness about and launch efforts to eliminate racial and ethnic inequities and disparities in cancer care both in the United States and globally; Sponsor: Sewell, Terri A. [Rep.-D-AL-7]; Committees: House – Energy and Commerce

 

H.R.7183-To prohibit Federal funds from being used to provide certain gender transition procedures to minors; Sponsor: McCormick, Richard [Rep.-R-GA-6]; Committees: House – Energy and Commerce

 

H.R.7185-To amend the Office of National Drug Control Prevention Act of 1998 to include new requirements for assessments and reports, and for other purposes; Sponsor: Duarte, John S. [Rep.-R-CA-13]; Committees: House – Oversight and Accountability; Judiciary

 

H.R.7186-To provide for the integration of participant treatment within the Continuum of Care Program with Certified Community Behavioral Health Clinics, and for other purposes; Sponsor: Calvert, Ken [Rep.-R-CA-41]; Committees: House – Financial Services

 

H.R.7188-To require the Secretary of Health and Human Services to conduct a national, evidence-based education campaign to increase public and health care provider awareness regarding the potential risks and benefits of human cell and tissue products transplants, and for other purposes; Sponsor: Moolenaar, John R. [Rep.-R-MI-2]; Committees: House – Energy and Commerce

 

H.R.7189-To amend the Public Health Service Act to reauthorize a national congenital heart disease research, surveillance, and awareness program, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce

 

H.R.7194-To amend the Toxic Substances Control Act to codify a Federal cause of action and a type of remedy available for individuals significantly exposed to per- and polyfluoroalkyl substances, to encourage research and accountability for irresponsible discharge of those substances, and for other purposes; Sponsor: Dean, Madeleine [Rep.-D-PA-4]; Committees: House – Energy and Commerce; Judiciary

 

H.R.7207-To amend title XVIII of the Social Security Act to prohibit the Secretary of Health and Human Services from selecting certain activities relating to the development of anti-racism plans as clinical practice improvement activities under the Medicare program; Sponsor: Palmer, Gary J. [Rep.-R-AL-6]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7208-To reauthorize the Traumatic Brain Injury program; Sponsor: Pascrell, Bill, Jr. [Rep.-D-NJ-9]; Committees: House – Energy and Commerce

 

H.R.7212-To address the behavioral health workforce shortages through support for peer support specialists, and for other purposes; Sponsor: Salinas, Andrea [Rep.-D-OR-6]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.7213-To amend the Public Health Service Act to enhance activities of the National Institutes of Health with respect to research on autism spectrum disorder and enhance programs relating to autism / reauthorize certain programs with respect to autism spectrum disorder, and for other purposes; Sponsor: Smith, Christopher H. [Rep.-R-NJ-4]; Committees: House – Energy and Commerce

 

H.R.7214-To require a report on access to maternal health care within the military health system, and for other purposes; Sponsor: Stefanik, Elise M. [Rep.-R-NY-21]; Committees: House – Armed Services

 

H.R.7215-To express the sense of Congress that aliens who are present in the United States without lawful status under the immigration laws should not receive any benefit under the Medicare program or under the Medicaid program; Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.7216-To direct the Secretary of Health and Human Services to revise regulations to remove the requirement under the Medicare program that an ambulatory surgical center shall report the COVID-19 vaccination status of health care personnel; Sponsor: Van Duyne, Beth [Rep.-R-TX-24]; Committees: House – Energy and Commerce; Ways and Means

Agreement on Topline Funding Numbers

Agreement on Topline Funding Numbers-House and Senate Appropriations Committee leaders reached an agreement late Friday night on funding totals for the 12 fiscal year (FY) 2024 appropriations bills. The House and Senate now have approximately one month to negotiate details of the spending bills, as current funding for federal agencies is set to expire on March 1 for some agencies and March 8 for the remainder, including the Department of Health and Human Services. Congress faces an effective April 30 deadline to pass the FY 2024 appropriations bills due to a provision in the most recent debt ceiling law that would impose an automatic spending cut on all discretionary funding should a continuing resolution still be in place at that time.

 

Senate Passes Legislation to Address the Nursing Shortage-The Senate passed the Train More Nurses Act (S. 2853) by unanimous consent last week. The legislation aims to strengthen the nursing workforce and improve pathways for licensed practical nurses to become registered nurses. The bill would require the secretaries of Labor and the U.S. Department of Health and Human Services to conduct a study on federal grant programs that support the nursing workforce.

 

Administration, Congressional Policymakers Consider MA Program Reforms-The Senate Finance Committee plans to investigate the marketing practices of five Medicare Advantage (MA) third-party marketing organizations: eHealth, GoHealth, Agent Pipeline, SelectQuote, and TRANZACT. Chairman Ron Wyden (D-Ore.) asserts that the sale of beneficiaries’ information has “led to a race to the bottom as unscrupulous actors put their own financial interests ahead of seniors’ health needs.” The panel has sent letters to each of the companies requesting information on their business practices.

 

The Centers for Medicare and Medicaid Services (CMS) has issued a request for information (RFI) seeking input on the MA program related to “access to care, prior authorization, provider directories, and networks; supplemental benefits; marketing; care quality and outcomes; value-based care arrangements and equity; and healthy competition in the market.” The RFI follows a letter from a bipartisan group of senators including Sens. Bill Cassidy (R-La.), Elizabeth Warren (D-Mass.), Marsha Blackburn (R-Tenn.), and Catherine Cortez Masto (D-Nev.) to the agency in December 2023 urging the administration to improve the data collection and reporting practices of MA plans. Responses to the RFI are due on May 29, 2024.

 

The Medicaid and CHIP Payment and Access Commission (MACPAC) voted on a series of recommendations during its meeting last week to streamline the appeals process for claims denials made by Medicaid managed care organizations (MCOs). The Commission proposed to allow third-party doctors to conduct external medical reviews of MCO claims denials. Similar policies are already in place in 14 states across the nation. The recommendation follows a 2023 report from the U.S. Department of Health and Human Services which found high rates of prior authorization denials by MCOs. The same report found that external medical reviewers made decisions in beneficiaries’ favor more often than when MCOs oversaw the claims adjudication process. MACPAC also voted to recommend that CMS issue guidance on MCO denial forms, and that states conduct audits of denials made by MCOs. MACPAC’s recommendations will be published in the Commission’s March 2024 Report to Congress.

 

Finance Leaders Consider Policies to Prevent Generic Drug Shortages-Senate Finance Committee Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) have released a white paper outlining policy proposals the Committee is exploring to address generic drug shortages through modifications to the Medicare and Medicaid programs. The panel is considering the following areas for legislative development this year:

  • Medicare Part A and B payment reforms to stabilize the supply of generic sterile injectable medicines;
  • New incentives for providers and other prescription drug supply chain stakeholders to engage in shortage prevention and mitigation activities;
  • Reforms or new pilot programs in Medicare Part D to bolster incentives for pharmacies to purchase generic medicines from drug manufacturers that invest in shortage mitigation, quality, and drug supply chain resilience; and
  • Potential reforms to the Medicaid Drug Rebate Program targeting generic medicines in shortage.

Lawmakers to Launch Digital Health Caucus; HHS Releases Goals for Cybersecurity-Reps. Troy Balderson (R-Ohio) and Robin Kelly (D-Ill.) plan to launch the Congressional Digital Health Caucus during an event hosted by the Consumer Technology Association on Thursday. The caucus will focus on ensuring access to the benefits of digital health tools for all Americans. The event on February 1 will feature speakers from Google, Microsoft, Amazon Web Services, and Hippocratic AI to discuss artificial intelligence in digital health care.

 

In related news, a bipartisan group of senators have sent a letter to Majority Leader Chuck Schumer (D-N.Y.) calling for the creation of a federal agency responsible for regulating the technology industry. “Congress must create a new agency with the resources and meaningful enforcement authority to regulate these firms in a comprehensive, considered, and continuous manner,” the letter states. “We can successfully mitigate the risks of AI while simultaneously addressing the harms American families and businesses experience every day in our digital world.” The Majority Leader has recently convened a series of AI Insight Forums underscoring the need for a comprehensive approach to artificial intelligence. The letter, which was signed by Sens. Michael Bennet (D-Colo.), Lindsey Graham (R-S.C.), Elizabeth Warren (D-Mass.), and Peter Welch (D-Vt.), also endorses the Digital Platform Commission Act (S. 1671) and the Digital Consumer Protection Commission Act (S. 2597) to establish a new enforcement authority to oversee the tech sector.

 

The U.S. Department of Health and Human Services (HHS) released a set of voluntary cybersecurity performance goals for the health care sector on Wednesday. The measures include both essential goals to strengthen basic cybersecurity as well as enhanced goals to protect against sophisticated cyber-attacks. The goals were accompanied by a new gateway website to help the health care and public health sector implement these practices.

 

Pharmaceutical Manufacturers Agree to Testify in Feb. 8 Hearing-The CEOs of Johnson & Johnson and Merck have agreed to testify before the Senate Health, Education, Labor and Pensions (HELP) Committee, alongside the CEO of Bristol Meyers Squibb, on the issue of prescription drug pricing during a hearing to be held of February 8. Chairman Bernie Sanders (I-Vt.) had planned to hold a vote this week on issuing subpoenas for the CEOs but canceled the Executive Session explaining that “The use of a subpoena was clearly a last resort and I’m delighted that these CEOs will be coming into our committee voluntarily.”

 

Lawmakers Urge White House to Oppose WTO COVID-19 IP Waiver-A bipartisan group of senators sent a letter to President Joe Biden last week urging the administration to oppose a World Trade Organization (WTO) proposal to waive intellectual property (IP) protections for COVID-19 diagnostics and therapeutics. “Waiving rules meant to incentivize the discovery and production of life-saving medicines will cause investors and innovators to shift their efforts elsewhere,” the lawmakers argue. “What is more, allowing foreign competitors to disregard IP protections for made-in-the-USA biomedical technologies would undercut U.S. businesses and undermine the efforts of the workers who brought those technologies to market.” The issue will be discussed at a WTO ministerial conference next month. The letter was led by Sens. Mike Crapo (R-Idaho), Chris Coons (D-Del.), Tom Carper (D-Del.), and Thom Tillis (R-N.C.) and signed by 10 other senators.

 

Congressional Retirements and Resignations-Rep. Kelly Armstrong (R-N.D.) announced his candidacy for Governor of North Dakota last week. Armstrong was first elected to the House of Representatives in 2018 and currently serves on the Energy and Commerce Committee. Rep. Dutch Ruppersberger (D-Md.) announced that he would retire at the end of his term. Ruppersberger has served in the House since 2003 and currently sits on the House Appropriations Committee.

 

A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Feinstein (D), CA
Manchin (D), WV
HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Spartz (R), IN
Schiff (D), CA Bishop (R), NC
Slotkin (D), MI Lesko (R), AZ
Allred (D), TX Granger (R), TX
Trone (D), MD Buck (R), CO
Blunt Rochester (D), DE Burgess (R), TX
Napolitano (D), CA Santos (R), NY (effective Dec. 1, 2023)
Wexton (D), VA Wenstrup (R), OH
Kim, Andy (D), NJ McHenry (R), NC
Jackson, Jeff (D), NC McCarthy (R), CA (effective Dec. 31, 2023)
Sarbanes (D), MD Johnson, Bill (R), OH (effective Jan. 21, 2024)
Blumenauer (D), OR Ferguson (R), GA
Kilmer (D), WA Curtis (R), UT
Spanberger (D), VA Luetkemeyer (R), MO
Kildee (D), MI Lamborn (R), CO
Phillips (D), MN Bucshon (R), IN
Cardenas (D), CA Pence (R), IN
Eshoo (D), CA Duncan (R), SC
Manning (D), NC Armstrong (R), ND
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC
Ruppersberger (D), MD

 

 

Upcoming Congressional Hearings and Markups

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “The Future of Data Privacy and Artificial Intelligence at VA;” 3:30 p.m.; January 29

 

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Overseeing the Department of Health and Human Services’ Compliance with Congress;” 10:00 a.m.; January 31

 

House Energy and Commerce Subcommittee on Health hearing “Health Care Spending in the United States: Unsustainable for Patients, Employers, and Taxpayers;” 10:00 a.m.; January 31

 

Senate Homeland Security and Governmental Affairs Committee Executive Session to consider nominations and legislation including S. 3558, to prohibit contracting with certain biotechnology providers; 10:15 a.m.; January 31

 

Senate Veterans’ Affairs Committee hearing “Vet Centers: Supporting the Mental Health Needs of Servicemembers, Veterans and their Families;” 3:30 p.m.; January 31

 

House Judiciary Committee field hearing “Artificial Intelligence and Intellectual Property: Part II-Identity in the Age of AI; 9:00 a.m. PT; Los Angeles, CA; February 2

 

Senate Health, Education, Labor, and Pensions Committee hearing on the high costs of prescription drugs for patients; 10:00 a.m.; February 8

 

Recently Introduced Health Legislation

H.R.7059-To amend the Public Health Service Act to authorize a grant program to increase capacity for providing abortion services and other sexual and reproductive health care, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Energy and Commerce

 

H.R.7063-To prohibit Federal funds from being made available to any pregnancy center that diverts people from accessing comprehensive and timely medical care from licensed medical professionals; Sponsor: Landsman, Greg [Rep.-D-OH-1]; Committees: House – Energy and Commerce

 

H.R.7068-To amend the Controlled Substances Act to provide for the scheduling of tianeptine as a schedule III substance, and for other purposes; Sponsor: Panetta, Jimmy [Rep.-D-CA-19]; Committees: House – Energy and Commerce; Judiciary

 

S.Res.530-A resolution designating January 23, 2024, as “Maternal Health Awareness Day”; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Judiciary

 

S.3638-A bill to allow health plan policyholders to obtain information about controlled substances prescribed to adult children enrolled in such plan; Sponsor: Vance, J. D. [Sen.-R-OH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3641-A bill to require the Secretary of Defense to establish a pilot program for evidence-based perinatal mental health prevention for pregnant and postpartum members of the Armed Forces and dependents, and for other purposes; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Armed Services

 

S.3651-A bill to amend title XVIII of the Social Security Act to ensure coverage of mental health services furnished through telehealth; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate-Finance

 

S.3653-A bill to apply user fees with respect to tobacco products deemed subject to the requirements of chapter IX of the Federal Food, Drug, and Cosmetic Act; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.532-A resolution recognizing and supporting the goals and ideals of National Medicolegal Death Investigation Professionals Week; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate-Judiciary

 

S.3663-A bill to provide funding for programs and activities under the SUPPORT for Patients and Communities Act; Sponsor: Shaheen, Jeanne [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.7085-To prohibit contracting with certain biotechnology providers, and for other purposes; Sponsor: Gallagher, Mike [Rep.-R-WI-8]; Committees: House – Oversight and Accountability

 

H.R.7087-To direct the Secretary of Defense to establish a pilot program for evidence-based perinatal mental health prevention for pregnant and postpartum members of the Armed Forces and beneficiaries, and for other purposes; Sponsor: Houlahan, Chrissy [Rep.-D-PA-6]; Committees: House – Armed Services

 

H.R.7090-To amend the Internal Revenue Code of 1986 to exclude from gross income certain compensation to clinical trial participants; Sponsor: Kelly, Mike [Rep.-R-PA-16]; Committees: House – Ways and Means

 

H.R.7091-To amend title 38, United States Code, to require medical facilities of the Department of Veterans Affairs to share certain data with State cancer registries, and for other purposes; Sponsor: Kiggans, Jennifer A [Rep.-R-VA-2]; Committees: House – Veterans’ Affairs; Energy and Commerce

 

H.R.7093-To provide for Congressional approval of public health emergency declarations, and for other purposes; Sponsor: Moore, Barry [Rep.-R-AL-2]; Committees: House – Energy and Commerce; Rules

Congress Passes CR, Averting Government Shutdown Until March

Congress Passes CR, Averting Government Shutdown Until March-Congress successfully passed another two-step stopgap spending bill (H.R. 2872) last week. The measure extends funding deadlines for federal agencies from January 19 and February 2 to March 1 and March 8. The Senate passed the bill in a 77-18 vote on Thursday. The CR was approved by the House of Representatives in a 314-108 vote hours later, and signed by President Joe Biden on Friday. House Speaker Mike Johnson (R-La.) had previously pledged to not pass any additional temporary spending measures, and nearly half the House Republican caucus voted against the bill in opposition to the Speaker’s dealmaking with congressional Democrats and in demand of immigration and border security policy changes. Last week, prior to passage of the CR, Congressional leadership announced bipartisan agreement on a $1.66 trillion topline spending cap for fiscal year (FY) 2024, and lawmakers hope the latest CR will provide enough time to negotiate the details of the 12 annual appropriations bills. Congress faces an effective April 30 deadline to pass appropriations for FY 2024 due to a provision included in the most recent debt ceiling compromise which would impose an automatic across the board spending cut should a CR still be in place at that time. House GOP leadership have announced a change to the chamber’s schedule for next month, deciding to cut their February recess short and hold votes February 28 through March 1.

 

 

CMS Releases Final Interoperability and E-Prior Authorization Regulation-The Centers for Medicare and Medicaid Services (CMS) released its final rule on advancing interoperability and improving prior authorization processes last week. The regulation would impose new requirements aimed at enhancing the electronic exchange of health care data and improving prior authorization processes. Provisions in the final rule apply to Medicare Advantage organizations, state Medicaid and Children’s Health Insurance Program (CHIP) fee-for-service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally Facilitated Exchanges. The rule requires impacted payers to implement an HL7 FHIR Patient Access application programming interface (API), a provider access API, a payer-to-payer API, and a prior authorization API. It also includes provisions to require impacted payers to send prior authorization decisions within 72 hours for urgent requests and seven calendar days for standard requests, to provide a specific reason for denied prior authorization decisions, and to publicly report certain prior authorization metrics on an annual basis. The regulation also adds a new “Electronic Prior Authorization” measure for Merit-based Incentive Payment System eligible clinicians and hospitals, including critical access hospitals. The regulation was praised by the congressional champions of the Improving Seniors’ Timely Access to Care Act, who stated that the regulation will “make a big difference in helping seniors access the medical care they are entitled to without unnecessary delays and denials.” Rep. Suzan DelBene (D-Wash.) explained that although the rule address many of the things that were in the bill, there are areas where CMS “could have gone further, especially in terms of speed of decision-making.” She and the other bill sponsors plan to review the final rule and “see what else we can do legislatively to not only solidify and codify what is in the rule, but also look at what we can do to try to increase speed of responses.”

 

HELP to Vote on Prescription Drug Pricing Investigation-The Senate Health, Education, Labor, and Pensions (HELP) Committee is set to vote on January 31 to authorize an investigation into the high costs of prescription drugs. The panel will also vote on subpoenaing the CEOs of Johnson & Johnson and Merck to testify about why the manufacturers charge “substantially higher prices for medicine in the U.S. compared to other countries.” Chairman Bernie Sanders (I-Vt.) will need a majority of his panel to vote in support of the subpoenas. If he is successful, it will be the first time the committee has subpoenaed anyone in more than 40 years.

 

Biden Administration Drops Appeal on the Copay Accumulator Decision-The Biden administration has dropped its previous appeal of an October U.S. District Court decision to strike down a 2021 rule allowing copay accumulators. The decision was praised by many lawmakers on Capitol Hill, including Sens. Tim Kaine (D-Va.) and Roger Marshall (R-Kan.) and Reps. Buddy Carter (R-Ga.), Nanette Barragan (D-Calif.), and Mariannette Miller-Meeks (R-Iowa), who had urged the administration to drop its appeal and introduced the HELP Copays Act (S. 1375/H.R. 830), which would prohibit the use of copay accumulator programs. Nineteen states have already acted to ban copay accumulator adjustment programs.

 

Schatz Leads Bipartisan Letter on Permanent Telehealth Flexibilities-A bipartisan group of senators led by Sen. Brian Schatz (D-Hawaii) have sent a letter to the U.S. Department of Health and Human Services (HHS) urging the administration to work with Congress to ensure that all Medicare beneficiaries have permanent access to telehealth services. Temporary COVID-era waivers expanding access to telehealth are currently set to expire on December 31, 2024. The letter urges Secretary Xavier Becerra to communicate to Congress and the public the authorities, appropriations, resources, and other supports needed to enact permanent telehealth legislation. The lawmakers also encourage HHS to solicit information from stakeholders to address any outstanding implementation questions related to permanent policy.

 

ARPA-H to Solicit Rural Care Proposals-The Advanced Research Projects Agency for Health (ARPA-H) has launched a program to increase access to early disease detection and hospital level care in rural areas of the country. The Platform Accelerating Rural Access to Distributed & Integrated Medical care (PARADIGM) program aims to support the development of mobile health units to extend the reach of rural hospitals. A forthcoming PARADIGM program solicitation will solicit proposals from a wide range of applicants with proposals for bringing advanced medical services to underserved rural populations throughout the country. More information about the PARADIGM program and the scheduled Proposers’ Day to be held the week of February 12 can be found here.

 

FDA, CMS Issue Joint Statement on Regulation of LDTs-The Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) issued a joint statement last week reiterating mutual support for FDA oversight of the analytical and clinical validity of laboratory developed tests (LDTs). The statement acknowledges the concerns that have been raised about the safety and effectiveness of LDTs, and responds to the suggestion that these concerns should be addressed through the expansion of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). “The FDA and CMS have long stood together in mutual support of FDA oversight of the analytical and clinical validity of LDTs,” the statement reads. “Applying the same oversight approach to laboratories and non-laboratories that manufacture tests would better assure the safety and effectiveness of LDTs and would remove a disincentive for non-laboratory manufacturers to develop novel tests that can be available to and used by many laboratories for many patients.”

 

Congressional Retirements and Resignations-Rep. Jeff Duncan (R-S.C.) announced his retirement last week. Duncan was first elected to Congress in 2010, and currently sits on the Energy and Commerce Committee.

 

 

House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) announced the selection of Rep. Buddy Carter (R-Ga.) to replace Rep. Bill Johnson (R-Ohio) as Chair of the Environment, Manufacturing, and Critical Materials Subcommittee. Johnson resigned from Congress effective this week to start as President at Youngstown State University.

 

A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Feinstein (D), CA
Manchin (D), WV
 

HOUSE OF REPRESENTATIVES

Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Spartz (R), IN
Schiff (D), CA Bishop (R), NC
Slotkin (D), MI Lesko (R), AZ
Allred (D), TX Granger (R), TX
Trone (D), MD Buck (R), CO
Blunt Rochester (D), DE Burgess (R), TX
Napolitano (D), CA Santos (R), NY (effective Dec. 1, 2023)
Wexton (D), VA Wenstrup (R), OH
Kim, Andy (D), NJ McHenry (R), NC
Jackson, Jeff (D), NC McCarthy (R), CA (effective Dec. 31, 2023)
Sarbanes (D), MD Johnson, Bill (R), OH (effective Jan. 21, 2023)
Blumenauer (D), OR Ferguson (R), GA
Kilmer (D), WA Curtis (R), UT
Spanberger (D), VA Luetkemeyer (R), MO
Kildee (D), MI Lamborn (R), CO
Phillips (D), MN Bucshon (R), IN
Cardenas (D), CA Pence (R), IN
Eshoo (D), CA Duncan (R), SC
Manning (D), NC
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC

 

 

 

Upcoming Congressional Hearings and Markups

Senate Judiciary Subcommittee on Intellectual Property hearing to examine the Patent Eligibility Restoration Act, focusing restoring clarity, certainty, and predictability to the U.S. patent system; 2:30 p.m.; January 23

 

Senate Committee on Environment and Public Works oversight hearing to examine the Toxic Substances Control Act amendments implementation; 10:00 a.m.; January 24

 

Senate Special Committee on Aging hearing “Assisted Living Facilities: Understanding Long-Term Care Options for Older Adults;” 10:00 a.m.; January 25

 

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “The Future of Data Privacy and Artificial Intelligence at VA;” 3:30 p.m.; January 29

 

Senate Health, Education, Labor, and Pensions Committee executive session to authorize an investigation into the high costs of prescription drugs for patients in the United States compared to other countries; 11:00 a.m.; January 31

 

Recently Introduced Health Legislation

H.R.6986-To address patent thickets; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House-Judiciary

 

H.R.6992-To require the Secretary of Health and Human Services to establish a list of essential medicines, and for other purposes; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce

 

H.R.6993-To allow individuals to choose to opt out of the Medicare part A benefit; Sponsor: Palmer, Gary J. [Rep.-R-AL-6]; Committees: House – Ways and Means

 

S.3597-A bill to reauthorize programs relating to oral health promotion and disease prevention; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3598-A bill to require the Secretary of Veterans Affairs to establish a comprehensive standard for timing between referrals and appointments for care from the Department of Veterans Affairs and to submit a report with respect to that standard, and for other purposes; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Veterans’ Affairs

 

S.3607-A bill 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: Lee, Mike [Sen.-R-UT]; Committees: Senate-Finance

 

S.3608-A bill to amend the Internal Revenue Code of 1986 to prohibit treatment of certain distributions and reimbursements for certain abortions as qualified medical expenses; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate-Finance

 

H.R.7002-To provide for a wage differential program to support new nursing school faculty members; Sponsor: Bonamici, Suzanne [Rep.-D-OR-1]; Committees: House – Energy and Commerce

 

H.R.7014-To amend title XIX of the Social Security Act to prohibit Federal Medicaid funding for the administrative costs of providing health benefits to individuals who are unauthorized immigrants; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce

 

H.R.7017-To amend the Internal Revenue Code of 1986 to take certain Medicare premiums of household members into account in determining the health care insurance premiums tax credit; Sponsor: Levin, Mike [Rep.-D-CA-49]; Committees: House – Ways and Means

 

S.3609-A bill to ensure that women seeking an abortion are informed of the medical risks associated with the abortion procedure and the major developmental characteristics of the unborn child, before giving their informed consent to receive an abortion; Sponsor: Blackburn, Marsha [Sen.-R-TN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3612-A bill to prohibit the limitation of access to assisted reproductive technology, and all medical care surrounding such technology; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3621-A bill 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: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3628-A bill to amend title XVIII of the Social Security Act to improve mobility crisis under the Medicare program; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate-Finance

 

S.3630-A bill to amend title XI of the Social Security Act to establish a pilot program for testing the use of a predictive risk-scoring algorithm to provide oversight of payments for durable medical equipment and clinical diagnostic laboratory tests under the Medicare program; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate-Finance

 

H.Res.976-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 Nations 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.7044-To ensure that women seeking an abortion are notified, before giving informed consent to receive an abortion, of the medical risks associated with the abortion procedure and the major developmental characteristics of the unborn child; Sponsor: McClain, Lisa C. [Rep.-R-MI-9]; Committees: House – Energy and Commerce

 

H.R.7049-To repeal the Department of Veterans Affairs directive relating to the COVID-19 vaccination program for Veterans Health Administration health care personnel, and for other purposes; Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Veterans’ Affairs

 

H.R.7050-To amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the substance use disorder crisis; Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.7056-To prohibit the limitation of access to assisted reproductive technology, and all medical care surrounding such technology; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Energy and Commerce

Leaders Agree to Extend Laddered Short-Term Funding Plan

Leaders Agree to Extend Laddered Short-Term Funding Plan-Congressional leadership have reached an agreement on a second two-step continuing resolution (CR) to avoid January 20 and February 2 partial government shutdowns. Leaders have coalesced around a CR that maintains House Speaker Mike Johnson’s (R-La.) laddered government funding approach, extending appropriations for federal agencies to March 1 and March 8. A section-by-section is available here, and the legislative text is available here.

 

Johnson had previously pledged to not pass another stopgap spending bill. The change of course follows an initial bipartisan agreement reached last week on topline spending amounts. Johnson insists that he is standing by the deal struck with Senate Majority Leader Chuck Schumer (D-N.Y.), despite criticism from far-right members of the House GOP, who have pressured him to abandon it. The deal includes $1.59 trillion in spending for fiscal year 2024 – $886 billion in defense and $704 billion in non-defense spending.

 

MedPAC Votes on Payment Update Recommendations-The Medicare Payment Advisory Commission (MedPAC) voted on its latest payment update recommendations for physicians, hospitals, and the post-acute care sector during its January meeting last week. The Commission recommends updating 2025 Medicare payments for physicians and other health professional services by the amount specified in current law plus half the Medicare Economic Index increase, and reiterated a prior recommendation to create a non-budget-neutral add-on payment under the Medicare physician fee schedule for services provided to low-income beneficiaries. MedPAC also voted to recommend a positive update for hospitals – current law amount plus 1.5% for 2025. Commissioners voted in support of lower base pay rates for skilled nursing facilities, home health agencies, and inpatient rehabilitation facilities, and recommended that Congress eliminate the 2024 update for hospices in 2025. MedPAC also recommended that Congress update the Medicare end-stage renal disease prospective payment system by the amount under current law.

 

HELP Chair Launches Investigation Into Pricing of Asthma Inhalers-Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) and Sens. Tammy Baldwin (D-Wis.), Ben Ray Lujan (D-N.M.), and Ed Markey (D-Mass.) have sent letters to AstraZeneca, Boehringer Ingelheim, GSK, and Teva to request details about the “extremely high prices” of the manufacturers’ asthma inhaler products. The letters ask for information on internal strategic communications, patient assistance programs, and the costs involved in the manufacturing of inhalers. “There is no reason for these products to be so expensive,” the lawmakers assert. “The devices have been available since the 1950s and most of the drugs they use have been on the market for more than 25 years.”

 

Fauci Completes Two Days of Interviews Before House Panel-Dr. Anthony Fauci provided two days of closed-door testimony before the House of Representatives Select Subcommittee on the Coronavirus Pandemic last week. According to reports, panel Republicans focused much of their questioning on the definition of gain of function research funded by the National Institutes of Health (NIH). Fauci was also questioned about the origins of COVID-19 and issues related to the federal government’s pandemic response, including federal records violations, conflicts of interest, and conflicting guidance. While the meetings produced few surprises or new information, Fauci has agreed to testify in a future open session before the committee.

 

ARPA-H to Solicit Preventive Care Proposals-The Advanced Research Projects Agency for Health (ARPA-H) has launched a program to increase investments in solutions to preventable health challenges in underserved communities. The Health care Rewards to Achieve Improved Outcomes  (HEROES) program aims to strengthen investment in community-level preventive care resources, particularly in places that have historically lacked access to medical and health care breakthroughs. A forthcoming HEROES program solicitation will solicit proposals from “Health Accelerators” – groups or organizations such as health consortiums or community health centers – aimed at health challenges in parts of the country where the associated health outcome is worse than the national average. More information about the HEROES program and the scheduled February 13-14 Proposers’ Day can be found here.

 

HHS Appoints First Ever Chief Competition Officer-Stacy Sanders has been appointed to serve as the first-ever Chief Competition Officer at the U.S. Department of Health and Human Services (HHS). The newly created position will be responsible for coordinating, identifying, and elevating opportunities across HHS to promote competition in health care markets, and will work with the Federal Trade Commission and Department of Justice to address concentration in health care markets through data-sharing, reciprocal training programs, and the further development of additional health care competition policy initiatives. Sanders most recently worked as a counselor to HHS Secretary Xavier Becerra, overseeing the Department’s implementation of the Inflation Reduction Act. Earlier in her career, Sanders worked as staff director for the Senate Special Committee on Aging and as federal policy director of the Medicare Rights Center.

 

OMB Clears CMS Prior Authorization Regulation-The Office of Management and Budget (OMB) has cleared a final rule from the Centers for Medicare and Medicaid Services (CMS) on prior authorization. The regulation will place new requirements on Medicare Advantage organizations, state Medicaid fee-for-service (FFS) programs, state Children’s Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally facilitated Exchanges to improve the electronic exchange of health care data and streamline processes related to prior authorization. The proposed rule, which was first published in December 2022, would also add a new measure for eligible hospitals and critical access hospitals, under the Medicare Promoting Interoperability Program, and for Merit-based Incentive Payment System (MIPS) eligible clinicians, under the Promoting Interoperability performance category of MIPS, to encourage providers to adopt the electronic prior authorization processes. Once the final rule is implemented, it should make it easier for Congress to advance the Improving Seniors’ Timely Access to Care Act – bipartisan prior authorization legislation which passed the House during the 117th Congress.

 

Congressional Retirements and Resignations-Rep. Larry Bucshon, MD (R-Ind.) has announced plans to retire at the end of this year. Bucshon, a cardiothoracic surgeon, has served in the House of Representatives since 2011. He is a member of the GOP Doctors Caucus. During his time in Congress, Bucshon has been a champion of diagnostics reform legislation (the VALID Act) as well as other bipartisan health measures, including proposals to related to the Medicare physician reimbursement system. He is a member of the Energy and Commerce Committee. Rep. Greg Pence (R-Ind.) has also determined that he will not seek reelection to the House this year. Pence was first elected to represent Indiana’s 6th Congressional District in 2018, filling the same seat held by former Vice President Mike Pence before he was elected Indiana governor. He currently serves on the Energy and Commerce Committee. Currently, the number of members who are retiring from Capitol Hill next year currently stands only slightly higher than the average of 34 retirements per election cycle.

 

California Governor Gavin Newsom (D) has set a special election to fill the seat of retired former House Speaker Kevin McCarthy (R). The all-parties special primary election will take place on March 19, several weeks following the primary scheduled to fill McCarthy’s seat for the full two-year term. If no candidate wins a majority of the votes in the March 19th primary, the top two finishers will compete in a May 21 runoff election.

 

A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Feinstein (D), CA
Manchin (D), WV
HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Spartz (R), IN
Schiff (D), CA Bishop (R), NC
Slotkin (D), MI Lesko (R), AZ
Allred (D), TX Granger (R), TX
Trone (D), MD Buck (R), CO
Blunt Rochester (D), DE Burgess (R), TX
Napolitano (D), CA Santos (R), NY (effective Dec. 1, 2023)
Wexton (D), VA Wenstrup (R), OH
Kim, Andy (D), NJ McHenry (R), NC
Jackson, Jeff (D), NC McCarthy (R), CA (effective Dec. 31, 2023)
Sarbanes (D), MD Johnson, Bill (R), OH (effective Jan. 21, 2023)
Blumenauer (D), OR Ferguson (R), GA
Kilmer (D), WA Curtis (R), UT
Spanberger (D), VA Luetkemeyer (R), MO
Kildee (D), MI Lamborn (R), CO
Phillips (D), MN Bucshon (R), IN
Cardenas (D), CA Pence (R), IN
Eshoo (D), CA
Manning (D), NC
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC

 

Upcoming Congressional Hearings and Markups

Senate Homeland Security & Governmental Affairs Committee hearing “The Cyber Safety Review Board: Expectations, Outcomes, and Enduring Questions;” 10:00 a.m.; January 17

 

Senate Health, Education, Labor, and Pensions hearing “Addressing Long COVID: Advancing Research and Improving Patient Care;” 10:00 a.m.; January 18

 

Recently Introduced Health Legislation

S.3560 – A bill to amend title 38, United States Code, to authorize pre-enrollment of certain combat service members of the Armed Forces in the system of annual patient enrollment of the Department of Veterans Affairs; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Veterans’ Affairs

 

S.3573 – A bill to amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate-Finance

 

S.3575 – A bill to amend the Public Health Service Act to give a preference, with respect to project grants for preventive health services, for States that allow all trained individuals to carry and administer epinephrine, and for other purposes; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6936 – To require Federal agencies to use the Artificial Intelligence Risk Management Framework developed by the National Institute of Standards and Technology with respect to the use of artificial intelligence; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Oversight and Accountability; Science, Space, and Technology

 

S.3578 – A bill to amend title XIX of the Social Security Act to prohibit Federal Medicaid funding for the administrative costs of providing health benefits to individuals who are unauthorized immigrants; Sponsor: Cassidy, Bill [Sen.-R-LA]; Committees: Senate – Finance

 

S.3583 – A bill to address patent thickets; Sponsor: Welch, Peter [Sen.-D-VT]; Committees: Senate – Judiciary

 

H.R.6956 – To amend title XIX of the Social Security Act to prohibit the Secretary of Health and Human Services from treating any Medicaid-related funds recovered from one or more pharmaceutical companies or drug distributors with respect to opioid litigation as an overpayment under such title, and for other purposes; Sponsor: Kaptur, Marcy [Rep.-D-OH-9]; Committees: House – Energy and Commerce

 

H.R.6960 – To amend the Public Health Service Act to reauthorize the Emergency Medical Services for Children program; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

H.R.6961 – To amend title XVIII of the Social Security Act to provide coverage of medical nutrition therapy services for individuals with eating disorders under the Medicare program; Sponsor: Chu, Judy [Rep.-D-CA-28]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6963 – To direct the Secretary of Health and Human Services to enter into agreements with drug manufacturers to establish reserve supplies of covered pediatric cancer drugs, and for other purposes; Sponsor: Eshoo, Anna G. [Rep.-D-CA-16]; Committees: House – Energy and Commerce

 

H.R.6965 – To amend title XXVII of the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986 to establish requirements with respect to cost sharing for epinephrine injectors under group health plans and group and individual health insurance coverage; Sponsor: Frost, Maxwell [Rep.-D-FL-10]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

H.R.6968 – To direct the Secretary of Health and Human Services to give marriage and family therapists participating in the National Health Service Corps Loan Repayment Program the option of completing a postgraduate degree clinical training program that is accredited by the State in which the program is located in lieu of such a program that is accredited by the Commission on Accreditation for Marriage and Family Therapy Education; Sponsor: Harder, Josh [Rep.-D-CA-9]; Committees: House – Energy and Commerce

 

H.R.6977 – To amend the Public Health Service Act to provide for a demonstration project for the development and publication of independent value assessments for drugs, and for other purposes; Sponsor: Nadler, Jerrold [Rep.-D-NY-12]; Committees: House – Energy and Commerce

 

H.R.6979 – To amend the Internal Revenue Code of 1986 to provide a credit to small businesses for research activities related to the mitigation of certain drug threats; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Ways and Means

 

H.R.6980 – To amend the Immigration and Nationality Act to provide for the reallocation of unused waivers of the foreign residency requirement for certain J-visa holders; Sponsor: Nehls, Troy E. [Rep.-R-TX-22]; Committees: House – Judiciary

Leadership Announces Bipartisan Agreement on Overall Funding Levels Ahead of First Shutdown Deadline

Leadership Announces Bipartisan Agreement on Overall Funding Levels Ahead of First Shutdown Deadline

Lawmakers return to session this week after congressional leadership on Sunday announced bipartisan agreement on topline spending amounts which provide a path to avoid a January 20 partial government shutdown. House Speaker Mike Johnson (R-La.) communicated the development in a Dear Colleague letter stating “The topline constitutes $1.590 trillion for FY24 – the statutory levels of the Fiscal Responsibility Act. That includes $886 billion for defense and $704 billion for nondefense.” Senate Majority Leader Chuck Schumer (D-N.Y.) and House Minority Leader Hakeem Jeffries (D-N.Y.) released a joint statement on the agreement stating that “The bipartisan topline appropriations agreement clears the way for Congress to act over the next few weeks in order to maintain important funding priorities for the American people and avoid a government shutdown.” Office of Management and Budget Director Shalanda Young characterized the work to pass funding for the Departments of Agriculture, Veterans Affairs, Energy, Agriculture-Food and Drug Administration, Transportation, and Housing and Urban Development ahead of the first government funding deadline on January 20 as “daunting,” with House Speaker Mike Johnson (R-La.) standing by his pledge to not pass another continuing resolution. No decisions have been reached regarding which health care related riders could be attached to the January spending vehicle. A Medicaid disproportionate share hospital cut delay and funding for several programs, including the community health center program, face a January 19 expiration. Other potential policy riders include a partial Medicare physician reimbursement fix, health transparency legislation, pharmacy benefit manager reforms, and site neutrality proposals. Congress has until February 2 to pass the Labor-Health and Human Services funding legislation and the other remaining annual appropriations bills.

 

Senators Comment on Co-pay Assistance Lawsuit

A bipartisan group of 19 senators led by Tim Kaine (D-Va.) and Roger Marshall (R-Kan.) are urging the Biden administration to drop its appeal of a court decision that struck down a regulation allowing insurers to avoid counting manufacturer co-pay assistance toward patients’ maximum out-of-pocket costs and deductibles. Patient advocacy groups, who brought the lawsuit against the U.S. Department of Health and Human Services (HHS), argued that the rule contradicts the statutory definition of cost sharing and would result in increased costs for patients. The lawmakers characterize the court decision as “an important step in the right direction for low-income and other eligible patients who rely on manufacturer and nonprofit copay assistance programs to alleviate affordability and access challenges for their medicines.” The letter also expresses support for the Help Ensure Lower Patient Copays Act (S. 1375/H.R. 830) that would prohibit the use of copay accumulators.

 

E&C GOP Launches Probe into Internal Scientific Disagreements at FDA

Republicans on the House Energy and Commerce Committee are investigating the handling of internal scientific disagreements related to regulatory decisions at the Food and Drug Administration (FDA). The lawmakers specifically cite the events surrounding the departure of several agency vaccine regulators following updated coronavirus vaccine recommendations in August 2021. Their letter seeks information on the adequacy of the FDA’s existing policies for handling scientific disagreements, and whether FDA leadership has taken retaliatory actions against dissenting FDA officials. It requests a written response from the agency by January 24.

 

FDA Approves FL Request to Import Drugs from Canada

The FDA has approved a plan from the state of Florida to allow the importation of prescription drugs from Canada. Before drug importation can commence, the state will first need to submit specific medications for FDA review and approval and ensure the products have been tested for authenticity and safety. In its letter authorizing the proposal, the agency stated that Florida has demonstrated that its plan “will significantly reduce the cost of covered products to the American consumer without posing additional risk to the public’s health and safety.” The agency has already denied a citizen petition from PhRMA to block the importation plan. Other states, including Colorado and New Hampshire, along with American Indian tribes have expressed interest in submitting similar applications to the FDA.

 

Congressional Retirements and Resignations

Reps. Doug Lamborn (R-Colo.) and Blaine Luetkemeyer (R-Mo.) each announced last week that they will not be seeking reelection this year. Lamborn has served in Congress since 2006 and is a member of the Armed Services and Natural Resources committees. Luetkemeyer was first elected to the House in 2008. He currently serves on the Financial Services and Small Business committees.

 

A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Feinstein (D), CA
Manchin (D), WV

 

HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Spartz (R), IN
Schiff (D), CA Bishop (R), NC
Slotkin (D), MI Lesko (R), AZ
Allred (D), TX Granger (R), TX
Trone (D), MD Buck (R), CO
Blunt Rochester (D), DE Burgess (R), TX
Napolitano (D), CA Santos (R), NY (effective Dec. 1, 2023)
Wexton (D), VA Wenstrup (R), OH
Kim, Andy (D), NJ McHenry (R), NC
Jackson, Jeff (D), NC McCarthy (R), CA (effective Dec. 31, 2023)
Sarbanes (D), MD Johnson, Bill (R), OH (effective Jan. 21, 2023)
Blumenauer (D), OR Ferguson (R), GA
Kilmer (D), WA Curtis (R), UT
Spanberger (D), VA Luetkemeyer (R), MO
Kildee (D), MI Lamborn (R), CO
Jackson Lee (D), TX
Phillips (D), MN
Cardenas (D), CA
Eshoo (D), CA
Manning (D), NC
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC

 

 

Upcoming Congressional Hearings and Markups

 

Senate Homeland Security and Governmental Affairs hearing “Harnessing AI to Improve Government Services and Customer Experience;” 10:00 a.m.; January 10

 

House Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing “Lowering Costs and Increasing Access to Health Care with Employer-Driven Innovation;” 10:15 a.m.; January 11

 

House Veterans’ Affairs Committee oversight hearing “Rural Access: Is VA Meeting All Veterans Where They Live?;” immediately following committee business meeting; 10:15 a.m.; January 11

OMB Provides Clarification Around Debt Ceiling Agreement Sequestration Provision

OMB Provides Clarification Around Debt Ceiling Agreement Sequestration Provision

According to guidance released on December 22, the Office of Management and Budget (OMB) has instructed federal agencies to not prepare for sequestration cuts at this time. The federal government is currently operating under a continuing resolution (CR) that funds some parts of the government through January 19 and others through February 2. Congress faces an effective April 30 deadline to pass fiscal year 2024 appropriations, given that the most recent debt ceiling agreement included a provision to subject all discretionary spending to a 1% automatic cut should a stopgap spending measure still be in place past that date. The OMB guidance sought to provide clarification around the April 30 date, given that the law states that the 1% cut will be required if Congress relies on a CR beyond December 31; OMB, however, is not required to issue a sequestration order until the end of April. The guidance also confirms that cuts will be negated once lawmakers reach a full-year funding deal, even if that occurs after the April 30 deadline. The sequestration spending cuts would only apply during the period in which a CR is in place beyond April 30.

 

Ways and Means Chair Comments on NSA Implementation

House Ways and Means Committee Chairman Jason Smith (R-Mo.) has released a statement on the administration’s “bungled” implementation of the No Surprises Act, following the release of a Government Accountability Office (GAO) report outlining the challenges with implementation of the 2020 law. “GAO’s report is further evidence that the Biden administration is failing to deliver this law’s promised benefits to patients and providers,” Smith states. “While I’m pleased the bipartisan advocacy of members of the Ways and Means Committee has contributed to a reduction of the dispute resolution process administrative fee, there’s much more that needs to be fixed. We will continue our efforts to hold the Biden administration accountable for ignoring the law’s clear Congressional intent.”

 

Administration Extends IDR Flexibilities Following Portal Reopening

On December 21, the U.S. Departments of Health and Human Services, Labor, and the Treasury announced an extension of the deadline for parties to complete certain independent dispute resolution (IDR) activities that were impacted by the temporary suspension of IDR operations due to litigation surrounding the implementation of the No Surprises Act. Parties for whom the IDR initiation deadline under applicable regulations fell on any date between August 3, 2023, and December 14, 2023, will have until March 14, 2024, to initiate a new batched dispute or a new single dispute involving air ambulance services. For disputes initiated between August 3, 2023, and January 21, 2024, the administrative fee amount is $50 per party per dispute. For disputes initiated on or after January 22, 2024, the administrative fee amount is $115 per party per dispute. Certified IDR entity fees for disputes initiated on or after January 22, 2024, may be updated to fall within the ranges finalized in the December 21, 2023, final rules to establish the new administrative fee amount and certified IDR entity fee ranges. The administration previously reopened the federal IDR portal to process all dispute types on December 15.

 

IRA Medicare Reforms Effective Jan. 1

Several Medicare reforms passed as a part of the 2022 Inflation Reduction Act are now in effect, including an expansion of the federal Low-Income Subsidy (LIS) program. There will no longer be a partial LIS program providing a lower level of financial support for certain individuals. Effective January 1, 2024, anyone who qualifies for the LIS program will get full program benefits, covering the majority, if not all, out-of-pocket costs for prescription medications. The new year also brings the elimination of the 5% coinsurance for Medicare Part D beneficiaries who have entered the catastrophic phase of their coverage.

 

Former Texas Congresswoman Eddie Bernice Johnson Dies at 88

Former Congresswoman Eddie Bernice Johnson (D) passed away on Sunday at the age of 88. Johnson was a nurse before entering politics, first serving as a Texas state lawmaker before being elected to the House of Representatives in 1992. She was the first African American and woman to serve as chair of the House Committee on Science, Space and Technology. She retired in 2021 after serving nearly 30 years in Congress.

 

Congressional Retirements and Resignations

Rep. John Curtis (R-Utah) is planning to announce his candidacy for the U.S. Senate early this month. Curtis was first elected to Congress in 2017 and currently serves as a member of the House Energy and Commerce Committee. Sen. Mitt Romney (R-Utah) previously announced his decision to not seek a second Senate term in September.

 

A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE

Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Feinstein (D), CA
Manchin (D), WV
 

HOUSE OF REPRESENTATIVES

Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Spartz (R), IN
Schiff (D), CA Bishop (R), NC
Slotkin (D), MI Lesko (R), AZ
Allred (D), TX Granger (R), TX
Trone (D), MD Buck (R), CO
Blunt Rochester (D), DE Burgess (R), TX
Napolitano (D), CA Santos (R), NY (effective Dec. 1, 2023)
Wexton (D), VA Wenstrup (R), OH
Kim, Andy (D), NJ McHenry (R), NC
Jackson, Jeff (D), NC McCarthy (R), CA (effective Dec. 31, 2023)
Sarbanes (D), MD Johnson, Bill (R), OH (effective after March 2024)
Blumenauer (D), OR Ferguson (R), GA
Kilmer (D), WA
Spanberger (D), VA
Kildee (D), MI
Jackson Lee (D), TX
Phillips (D), MN
Cardenas (D), CA
Eshoo (D), CA
Manning (D), NC
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC

 

Recently Introduced Health Legislation

H.R.6903 – To direct the Secretary of Defense to develop a plan to ensure an adequate supply of medications for the military health system. Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

 

H.R.6897 – To require the Secretary of Defense to establish a pilot program to evaluate novel pharmaceutical manufacturing technologies to reduce the reliance of the Department on foreign manufacturers for active pharmaceutical ingredients and key starting materials. Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

 

H.R.6895 – To amend the National Defense Authorization Act for Fiscal Year 2023 to extend Federal support for bioindustrial manufacturing processes to include support for the manufacturing of certain pharmaceutical ingredients. Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

 

H.R.6892 – To provide for the coverage of medically necessary food and vitamins and individual amino acids for digestive and inherited metabolic disorders under Federal health programs and private health insurance, to ensure State and Federal protection for existing coverage, and for other purposes. Sponsor: McGovern, James P. [Rep.-D-MA-2]; Committees: House – Energy and Commerce; Ways and Means; Oversight and Accountability; Armed Services

 

H.R.6884 – To increase the minimum levels of financial responsibility for transporting property, and to index future increases to changes in inflation relating to medical care. Sponsor: Garcia, Jesus G. “Chuy” [Rep.-D-IL-4]; Committees: House – Transportation and Infrastructure

 

H.R.6881 – To direct the Federal Trade Commission to establish standards for making publicly available information about the training data and algorithms used in artificial intelligence foundation models, and for other purposes. Sponsor: Beyer, Donald S., Jr. [Rep.-D-VA-8]; Committees: House – Energy and Commerce

House Adjourns for Holiday Recess

House Speaker Mike Johnson (R-La.) sent the House of Representatives home for the holidays last week following the chamber’s passage of the fiscal year 2024 National Defense Authorization Act (H.R. 2670) by a vote of 310-118. The $886 billion defense policy bill was passed over the objection of 73 hardline conservative members of his caucus, who rejected the package negotiated with Democrats, which preserves the Pentagon’s abortion travel policy. The House is scheduled to reconvene on January 9, 10 days before Congress’ first government funding deadline. The Senate has delayed its holiday recess to continue negotiations on aid for Ukraine. Senate Majority Leader Chuck Schumer (D-N.Y.) has stated that the chamber will vote on aid this week whether or not a deal has been reached.

 

House Passes Health Transparency Bill, SUPPORT Act Reauthorization

The House of Representatives passed the Lower Costs, More Transparency Act (H.R. 5378) in a bipartisan 320-71 vote last week. The package is focused on increasing transparency in the hospital, insurer, and pharmacy benefit manager (PBM) industries. It includes many provisions previously advanced by the Energy and Commerce, Ways and Means, and Education and the Workforce committees, drawing much from the PATIENT Act, to provide patients with timelier and more accurate information about the cost of health care procedures and services. It also increases funding for community health centers and the Teaching Health Centers Graduate Medical Education program. The Congressional Budget Office estimates that the package would cut $715 million from the deficit over the next decade. The bill’s fate in the Senate remains unclear. The Senate Finance Committee and Senate Health, Education, Labor, and Pensions (HELP) Committee have each advanced their own PBM- related measures out of committee this year.

 

The House also passed the Support for Patients and Communities Reauthorization Act (H.R. 4531) last week in a 386-37 vote. The package would reauthorize the 2018 law’s substance use disorder treatment and recovery support services, prevention programming, and long-term recovery services through fiscal year 2028. The programs expired at the end of September. The Senate HELP Committee advanced its own version of the reauthorization bill (S. 644, as amended) out of committee last week in a 19-1 vote.

 

Democrats Probe Pharmacies Protection of Patient Privacy

Sen. Ron Wyden (D-Ore.), Rep. Pramila Jayapal (D-Wash.), and Rep. Sara Jacobs (D-Calif.) have sent a letter to the U.S. Department of Health and Human Services (HHS) regarding federal health privacy regulations. The lawmakers detail the findings of an oversight inquiry into the privacy practices of pharmacies related to law enforcement demands for patient records which found that none of the eight major pharmacy chains surveyed require a warrant prior to sharing pharmacy records with law enforcement agents. The letter urges HHS to consider further strengthening its HIPAA regulations “to more closely align them with Americans’ reasonable expectations of privacy and Constitutional principles.”

 

Carter, Barragan Lead Comments on Co-pay Assistance Lawsuit

Abipartisan group of 48 members of Congress are urging the U.S. Department of Health and Human Services to drop its appeal of a court decision that struck down a regulation allowing insurers to avoid counting manufacturer co- pay assistance toward patients’ maximum out-of-pocket costs and deductibles. Patient advocate groups, who brought the lawsuit against the department, argued that the rule contradicts the statutory definition of cost sharing and would result in increased costs for patients. The letter, led by Reps. Buddy Carter (R-Ga.) and Nanette Barragan (D-Calif.), expresses support for the court decision as “an important step in the right direction for patients who rely on manufacturer copay assistance to alleviate affordability and access challenges for their medicines.”

 

E&C GOP Demands Answers on FDA Foreign Drug Inspection Program

Republican leadership of the House Energy and Commerce Committee are threatening to subpoena Food and Drug Administration (FDA) leadership if they do not cooperate with an investigation into the agency’s inspection of foreign drug facilities. The lawmakers reiterate their concerns, originally shared in a July letter to the agency, about the quality of drugs produced in India and China and the impact of subsequent drug shortages on patients. “The U.S. cannot afford additional disruptions to the drug supply chain that reduce the availability of essential medications and force doctors and patients to make difficult treatment decisions,” the letter argues. Lawmakers are prepared to issue a subpoena by January 5 should the FDA fail to provide the requested documentation.

 

GAO Details Challenges of NSA Implementation

The Government Accountability Office released a new report last week on the implementation of the No Surprises Act (NSA). The report reviews the more than 490,000 payment disputes initiated between providers and insurers from April 2022 through June 2023, which is nearly 20 times more than regulators’ expectation. While 61% of these disputes remain unresolved, providers have prevailed in 77% of disputes in which a payment determination has been reached. The report attributes the large number of unresolved disputes to the complexity of determining whether disputes are eligible for the independent dispute resolution process.

 

Missouri Implements First PDMP

On December 13th, Missouri launched a statewide prescription drug monitoring program (PDMP) to help pharmacists, doctors, and other health professionals reduce abuse and misuse of Schedule II, III, and IV controlled substances in the state. The Missouri legislature approved the establishment of a statewide PDMP in 2021. For years, Missouri was the only state without a statewide PDMP; instead, the St. Louis County Department of Public Health operated a PDMP that served 75 jurisdictions within the state. The St. Louis PDMP plans to cease operations as a result of the new statewide program.

 

Congressional Retirements and Resignations

A running list of members of Congress who are retiring or seeking other office can be found below.

 

Recently Introduced Health Legislation

S.3458 – A bill to amend title XVIII of the Social Security Act to clarify the application of the in-office ancillary services exception to the physician self-referral prohibition for drugs furnished under the Medicare program; Sponsor: Sinema, Kyrsten [Sen.-I-AZ]; Committees: Senate – Finance

 

S.3462 – A bill to require the Secretary of Health and Human Services to issue draft guidance to address non-addictive analgesics for chronic pain; Sponsor: Marshall, Roger [Sen.-R-KS]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6693 – To amend title XVIII of the Social Security Act to authorize the coverage of additional lung cancer screening tests under the Medicare program; Sponsor: Buchanan, Vern [Rep.-R-FL-16]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6705 – To require the Secretary of Health and Human Services to treat certain tests for tuberculosis as breakthrough devices eligible for expedited development and priority review, to require certain establishments that perform donor screening or testing to screen or test for active and latent tuberculosis, and for other purposes; Sponsor: Moolenaar, John R. [Rep.-R-MI-2]; Committees: House – Energy and Commerce

 

H.R.6716 – To amend title XXVII of the Public Health Service Act to provide for a special enrollment period for pregnant women, and for other purposes; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce; Oversight and Accountability

 

S.3464 – A bill to support endemic fungal disease research, incentivize fungal vaccine development, discover new antifungal therapies and diagnostics, and for other purposes; Sponsor: Kelly, Mark [Sen.-D-AZ]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6731 – To support endemic fungal disease research, incentivize fungal vaccine development, discover new antifungal therapies and diagnostics, and for other purposes; Sponsor: Schweikert, David [Rep.-R-AZ-1]; Committees: House – Energy and Commerce

 

H.R.6732 – To amend title XI of the Social Security Act to clarify parameters for model testing and add accountability to model expansion under the Center for Medicare and Medicaid Innovation, and for other purposes; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Energy and Commerce; Ways and Means; Rules

 

S.Res.496 – A resolution designating September 2023 as “National Cholesterol Education Month” and September 30, 2023, as LDL-C Awareness Day; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate – Judiciary

 

S.3481 – A bill to amend title XVIII of the Social Security Act to expand and expedite access to cardiac rehabilitation programs and pulmonary rehabilitation programs under the Medicare program, and for other purposes; Sponsor: Capito, Shelley Moore [Sen.-R-WV]; Committees: Senate – Finance

 

S.3482 – A bill to establish a multi-stakeholder advisory committee tasked with providing detailed recommendations to address challenges to transmitting geolocation information with calls to the 988 Suicide and Crisis Lifeline, and for other purposes; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Commerce, Science, and Transportation

 

S.3490 – A bill to prohibit the Secretary of Veterans Affairs from providing health care to, or engaging in claims processing for health care for, any individual unlawfully present in the United States who is not eligible for health care under the laws administered by the Secretary; Sponsor: Tuberville, Tommy [Sen.-R-AL]; Committees: Senate – Veterans’ Affairs

 

S.3498 – A bill to amend title XVIII of the Social Security Act to provide for coverage of peer support services under the Medicare program; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Finance

 

S.3501 – A bill to provide greater support for grandfamilies and older caregiver relatives; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.3503 – A bill to direct the Secretary of Health and Human Services to revise certain regulations in relation to the Medicare shared savings program and other alternative payment arrangements to encourage participation in such program, and for other purposes; Sponsor: Whitehouse, Sheldon [Sen.-D-RI]; Committees: Senate – Finance

 

S.3509 – A bill to amend title XXVII of the Public Health Service Act to provide for a special enrollment period for pregnant persons, and for other purposes; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate – Finance

 

H.R.6742 – To establish a pilot program to provide an add-on payment to certain plans offering benefits designed to address the needs of dual-eligible individuals related to social determinants of health, and to provide administrative flexibility to improve integration for certain dual-eligible individuals; Sponsor: Blumenauer, Earl [Rep.-D-OR-3]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.6743 -To amend the Public Health Service Act to include public awareness about menopause and related chronic conditions, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.6744 – To prohibit the Secretary of Veterans Affairs from providing health care to, or engaging in claims processing for health care for, any individual unlawfully present in the United States who is not eligible for health care under the laws administered by the Secretary; Sponsor: Bost, Mike [Rep.-R-IL-12]; Committees: House – Veterans’ Affairs

 

H.R.6746 – To amend the Public Health Service Act to provide for a public awareness campaign with respect to iron deficiency; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Energy and Commerce

 

H.R.6748 – To amend title XVIII of the Social Security Act to provide for coverage of peer support services under the Medicare program; Sponsor: Chu, Judy [Rep.-D-CA-28]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6749 – To require the Director of the National Institutes of Health to evaluate the results and status of completed and ongoing research related to menopause, perimenopause, or mid-life women’s health, to conduct and support additional such research, and for other purposes; Sponsor: Clarke, Yvette D. [Rep.-D-NY-9]; Committees: House – Energy and Commerce

 

H.R.6763 – To establish a multi-stakeholder advisory committee tasked with providing detailed recommendations to address challenges to transmitting geolocation information with calls to the 988 Suicide and Crisis Lifeline, and for other purposes; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce

 

H.R.6764 – To direct the Secretary of Health and Human Services to modify the HIPAA privacy regulation with respect to the disclosure of certain protected health information; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Energy and Commerce

 

H.R.6768 – To amend the Public Health Service Act to require the Secretary of Health and Human Services to carry out activities to establish, expand, and sustain a public health nursing workforce, and for other purposes; Sponsor: Stansbury, Melanie Ann [Rep.-D-NM-1]; Committees: House – Energy and Commerce

 

S.Res.507 – A resolution designating September 25, 2023, as “National Ataxia Awareness Day”, and raising awareness of ataxia, ataxia research, and the search for a cure; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.510 – A resolution expressing the sense of the Senate that the scientific judgement of the Food and Drug Administration that mifepristone is safe and effective should be respected, and law and policy governing access to lifesaving, time-sensitive medication abortion care in the United States should be equitable and based on science; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3519 – A bill to direct the Secretary of Health and Human Services to issue guidance on whether hospital emergency departments should implement fentanyl testing as a routine procedure for patients experiencing an overdose, and for other purposes; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3525 – A bill to require the Secretary of Health and Human Services to maintain a peer-to-peer support line to provide emotional support, information, brief intervention, and mental health resources to youth who are experiencing stress or who are at risk of, or affected by, mental health disorders, and to establish a grant program for local educational agencies to employ school-based mental health coordinators; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3532 – A bill to amend the Public Health Service Act to provide for the establishment of a Task Force on Youth Mental Health Data Integration; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3545 – A bill to amend the Public Health Service Act with respect to public health data accessibility, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3546 – A bill to require a study on the quality of care difference between mental health and addiction therapy care provided by health care providers of the Department of Veterans Affairs compared to non-Department providers, and for other purposes; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Veterans’ Affairs

 

S.3548 – A bill to amend the Public Health Service Act to provide for hospital and insurer price transparency; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3550 – A bill to clarify training requirements for prescribers of controlled substances; Sponsor: Bennet, Michael F. [Sen.- D-CO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3552 – A bill to amend the Taxpayer Certainty and Disaster Tax Relief Act of 2020 to allow qualified tax-exempt organizations to claim the employee retention credit for employers affected by qualified disasters against Medicare hospital insurance taxes; Sponsor: Kennedy, John [Sen.-R-LA]; Committees: Senate – Finance

 

H.Res.937 – Raising awareness for the sarcoma cancer chordoma; Sponsor: Johnson, Henry C. “Hank,” Jr. [Rep.-D-GA-4]; Committees: House – Energy and Commerce

 

H.R.6780 – To amend title XVIII of the Social Security Act to establish a Medically Tailored Home-Delivered Meals Demonstration Program to test a payment and service delivery model under part A of Medicare to improve clinical health outcomes and reduce the rate of readmissions of certain individuals; Sponsor: McGovern, James P. [Rep.-D-MA-2]; Committees: House – Ways and Means

 

H.R.6790 – To amend the Public Health Service Act with respect to preventing end-stage kidney disease, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6791 – To amend the Digital Equity Act of 2021 to facilitate artificial intelligence literacy opportunities, and for other purposes; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]; Committees: House – Energy and Commerce

 

H.R.6794 – To amend title XVIII of the Social Security Act to extend the Medicare independence at home medical practice demonstration program; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.6800 – To amend title 38, United States Code, to codify the requirements for appointment, qualifications, and pay for therapeutic medical physicists of the Department of Veterans Affairs, and for other purposes; Sponsor: Cherfilus- McCormick, Sheila [Rep.-D-FL-20]; Committees: House – Veterans’ Affairs

 

H.R.6801 – To amend title XVIII of the Social Security Act to ensure that remote physiologic monitoring services are not subject to cost sharing under the Medicare program; Sponsor: Cherfilus-McCormick, Sheila [Rep.-D-FL-20]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.6802 – To improve supply chain resiliency for critical drug products with vulnerable supply chains and ensure that reserves of critical drugs and active pharmaceutical ingredients are maintained to prevent supply disruptions in the event of drug shortages or public health emergencies; Sponsor: Craig, Angie [Rep.-D-MN-2]; Committees: House – Energy and Commerce

 

H.R.6803 – To provide greater support for grandfamilies and older caregiver relatives; Sponsor: Davis, Danny K. [Rep.-D- IL-7]; Committees: House – Ways and Means; Education and the Workforce; Energy and Commerce; Financial Services

 

H.R.6804 – To amend the Public Health Service Act to establish a grant program to provide self-harm and suicide prevention services in primary care offices, and for other purposes; Sponsor: DeSaulnier, Mark [Rep.-D-CA-10]; Committees: House – Energy and Commerce

 

H.R.6807 – To increase funding for cancer research by the National Cancer Institute to be more in proportion to the mortality rates of cancer; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Appropriations; Energy and Commerce

 

H.R.6815 – To require the Nuclear Regulatory Commission to revise its regulations to protect patients from unintended exposure to radiation during nuclear medicine procedures, and for other purposes; Sponsor: Griffith, H. Morgan [Rep.-R- VA-9]; Committees: House – Energy and Commerce

 

H.R.6829 – To amend the Public Health Service Act to authorize and support the creation and dissemination of cardiomyopathy education, awareness, and risk assessment materials and resources to identify more at-risk families, to authorize research and surveillance activities relating to cardiomyopathy, and for other purposes; Sponsor: Pallone, Frank, Jr. [Rep.-D-NJ-6]; Committees: House – Energy and Commerce

 

H.R.6835 – To amend the Older Americans Act of 1965 to establish a grant program for multigenerational activities for long-term care facilities; Sponsor: Strickland, Marilyn [Rep.-D-WA-10]; Committees: House – Education and the Workforce

Health Transparency Bill to be Considered Under Suspension of the Rules

The House of Representatives is scheduled to vote on the Lower Costs, More Transparency Act (H.R. 5378) under suspension of the rules this week. The package is focused on increasing transparency in the hospital, insurer, and pharmacy benefit manager (PBM) industries. It includes many provisions previously advanced by the Energy and Commerce, Ways and Means, and Education and the Workforce committees, drawing much from the PATIENT Act, to provide patients with timelier and more accurate information about the cost of health care procedures and services. It also increases funding for community health centers and the Teaching Health Centers Graduate Medical Education Program. Since being pulled from floor consideration earlier this year, the bill now reportedly has the bipartisan support of leadership from both the Energy and Commerce and Education and Workforce committees. The chamber is also scheduled to consider H.R. 4531, the Support for Patients and Communities Reauthorization Act, under suspension of the rules. The bill would reauthorize substance use disorder treatment and recovery support services, prevention programming, and long-term recovery services.

 

Energy and Commerce Advances 19 Health Bills

The House Energy and Commerce Committee advanced a slate of health care related bills last week, including legislation to reform the pharmacy benefit manager (PBM) industry, lower the cost of prescription drugs, and increase stability in the Medicare payment system.

  • H.R. 5372, Expanding Seniors’ Access to Lower Cost Medicines Act of 2023 was passed by a vote of 48-0.
  • H.R. 2880, Protecting Patients Against PBM Abuses Act, was passed by a vote of 46-0.
  • H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare part D, and for other purposes, was passed by a vote of 44-0.
  • H.R. 5385, Medicare PBM Accountability Act, was passed by a vote of 44-0.
  • H.R. 5386, Cutting Copays Act, was passed by a vote of 41-1.
  • H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program, was passed by a vote of 45-0.
  • H.R. 5389, National Coverage Determination Transparency Act, was passed by a vote of 46-0.
  • H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act, was passed by a vote of 42-0.
  • H.R. 5396, Coverage Determination Clarity Act of 2023, was passed by a vote of 44-0.
  • H.R. 5371, Choices for Increased Mobility Act of 2023, was passed by a vote of 41-0.
  • H.R. 5388, Supporting Innovation for Seniors Act, was passed by a vote of 43-0.
  • H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage, was passed by a vote of 43-0.
  • H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023, was passed by a vote of 44-0.
  • H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023, was passed by a vote of 46-0.
  • H.R. 5555, DMEPOS Relief Act of 2023, was passed by voice vote.
  • H.R. 2365, National Plan to End Parkinson’s Act, was passed by a vote of 47-0.
  • H.R. 6545, Physician Fee Schedule Update and Improvements Act, was passed by a vote of 46-0.
  • H.R. 6364, Medicare Telehealth Privacy Act of 2023, was passed by a vote of 44-0.
  • H.R. 1352, Increasing Access to Biosimilars Act of 2023, was passed by a vote of 44-0.

 

Rep. Murphy Introduces Legislation to Fully Avert Medicare Physician Cut

Abipartisan group of lawmakers led by Rep. Greg Murphy (R-N.C.) introduced legislation last week that would eliminate the impending 3.37% Medicare reimbursement cut for physicians scheduled to go into effect on January 1. Original cosponsors of the Preserving Seniors’ Access to Physicians Act (H.R. 6683) include Reps. Danny Davis (D-Ill.), Brad Wenstrup (R-Ohio), Jimmy Panetta (D-Calif.), Larry Bucshon (R-Ind.), and Michael Burgess (R-Texas). The version of the Physician Fee Schedule Update and Improvements Act (H.R. 6545) advanced by the House Energy and Commerce Committee last week (see above) would increase support for physicians and other practitioners by changing the add-on adjustment from 1.25% to 2.5%, while also extending incentive payments for participating in eligible alternative payment models (APMs), updating the budget neutrality threshold from $20 million to $53 million, and ensuring timely updates to direct costs used to calculate practice expense relative value units.

 

House Passes TRANQ Research Act, VA Home Care Legislation

The House of Representatives passed the Testing, Rapid Analysis, and Narcotic Quality (TRANQ) Research Act (H.R. 1734), as amended by the Senate in June, by voice vote last week. The bill requires the National Institute of Standards and Technology to support research and other activities related to identifying xylazine (a compound used in veterinary medicine as a nonopioid tranquilizer), novel synthetic opioids, and other new psychoactive substances, and will now be sent to President Joe Biden for his signature. The chamber also passed the Elizabeth Dole Home Care Act (H.R. 542) in a 414-5 vote. The bill expands community-based services for aging veterans and aims to improve VA support for veterans and caregivers of all ages.

 

Budget Committee Leaders to Investigate Private Equity Hospital Ownership

Sens. Sheldon Whitehouse (D-R.I.) and Chuck Grassley (R-Iowa) have launched an investigation into the involvement of private equity in the nation’s hospitals. The lawmakers are requesting information from hospital system executives about the impact of their financial arrangements on patients, clinicians, and profits. The probe centers on Lifepoint Health and its owner Apollo Global Management. The lawmakers highlight the significant staffing reductions and substandard health care that has resulted in many hospitals following private equity acquisition. They are requesting details about related-party transactions and the degree to which private equity firms “are calling the shots” at these hospitals.

 

HELP Ranking Member Issues RFI on Gene Therapies

Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-La.) is requesting information from stakeholders on ways to improve and protect access to gene therapies for Americans with ultra-rare diseases. Cassidy intends to use the feedback received to inform future legislation to modernize and improve the market structure for gene therapies to ensure that it supports the continued development of innovative treatments for Americans with ultra-rare diseases. Responses should be submitted to [email protected] by January 22, 2024.

 

FDA Approves Groundbreaking CRISPR Drug for Treatment of Sickle Cell

The Food and Drug Administration (FDA) has approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. The agency approved both Casgevy, from Vertex Pharmaceuticals and CRISPR Therapeutics, and Lyfgenia, from Bluebird Bio., for the treatment of SCD on Friday. Casgevy is the FDA-approved treatment to use the genome-editing technology CRISPR. Lyfgenia is a cell-based gene therapy which uses a lentiviral vector (gene delivery vehicle) for genetic modification. The treatments are intended for patients with history of SCD related pain crises that can damage organs – a patient population estimated to include 10 to 20 percent of the approximately 100,000 individuals in the U.S. with SCD.

 

DEA Telehealth Regulations Forthcoming

The Drug Enforcement Administration (DEA) will propose new regulations for the prescription of controlled substances via telehealth this month, according to the Biden administration’s updated regulatory agenda. The agency’s COVID-era flexibilities permitting physicians to prescribe controlled substances without an in-person visit were extended through the end of 2024 earlier this year. The extension came in response to a mass of comments expressing concern with the DEA’s prior proposal to reinstate limitations around the remote prescribing of controlled substances and a requirement that an in-person visit occur prior to the prescription of controlled drugs via telehealth. The extra time was intended to give patients and providers time to adapt to the new rules once DEA promulgated a final set of regulations.

 

Congressional Retirements and Resignations

Former House Speaker Kevin McCarthy (R-Calif.) has announced plans to leave Congress later this month. McCarthy has served as a member of Congress since 2007. He was elected House Speaker in January 2023, but was ousted less than 10 months later by hardline conservatives displeased with a government funding deal brokered by McCarthy with the Biden administration and Senate Democrats. His departure from the House of Representatives will narrow the GOP’s majority in the chamber by one more vote least temporarily. California Governor Gavin Newsom’s office has stated that they are awaiting specifics around the timing of McCarthy’s departure to determine the next step toward filling his seat. In announcing his decision to resign, McCarthy stated that his political work was “only getting started” and that he “will continue to recruit our country’s best and brightest to run for elected office.”

 

Rep. Patrick McHenry (R-N.C.) will retire when his current term ends in January 2025. McHenry currently chairs the Financial Services Committee. He rose to prominence during his tenure of House speaker pro tempore following the ousting of former speaker Kevin McCarthy in October. He has served in the House since 2005.

 

Rep. Kathy Manning (D-N.C.) also announced that she will not seek reelection next year. Her decision follows North Carolina’s approval of new congressional maps that would have made winning reelection more difficult. “I won’t file for re-election in the egregiously gerrymandered Congressional districts,” Manning wrote on X, formerly known as Twitter. Manning has served two terms in Congress and currently sits on the Education and Workforce Committee.

 

In related election news, former congressional health policy staffer Kyle Hill announced his campaign for Congress last week. During his time on Capitol Hill in the offices of Reps. Steve Israel (D-N.Y.) and Suzan DelBene (D-Wash.), Hill helped craft the Seniors’ Timely Access to Care Act. He is a former registered dietitian and current volunteer emergency medical technician. He joins incumbent Rep. Nick LaLota (R), James Gaughran (D), Craig Herskowitz (D), Nancy Goroff (D), and Andy DeCecco (D) vying to represent New York’s 1st Congressional District.

 

A running list of other members of Congress who are retiring or seeking other office can be found below.


 

Upcoming Congressional Hearings and Markups

Senate Health, Education, Labor, and Pensions (HELP) Committee executive session to consider S. 1840, SCREENS for Cancer Act of 2023; S. 3392, Advancing Research in Education Act; S. 3393, SUPPORT for Patients and Communities Reauthorization Act; and S. 644, Modernizing Opioid Treatment Access Act; 10:00 a.m.; December 12

 

House Homeland Security Subcommittee on Cybersecurity and Infrastructure Protection hearing “Considering DHS’ and CISA’s Role in Securing Artificial Intelligence;” 10:00 a.m.; December 12

 

House Veterans’ Affairs Subcommittee on Health hearing “Staff Sergeant Parker Gordon Fox Suicide Prevention Grants: Saving Veterans’ Lives Through Community Connection;” 10:30 a.m.; December 12

 

Senate Special Committee on Aging hearing “Understanding a Growing Crisis: Substance Use Trends Among Older Adults;” 9:30 a.m.; December 14

 

Senate HELP Committee hearing “What is Fueling the Diabetes Epidemic?;” 10:00 a.m.; December 14

 

Recently Introduced Health Legislation

H.Res.904 – Supporting the goals of World AIDS Day. Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Energy and Commerce; Foreign Affairs

 

H.R.6545 – to amend title XVIII of the Social Security Act to make improvements to the physician fee schedule under the Medicare program. Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House – Energy and Commerce; Ways and Means

 

S.Res.483 – A resolution commending the officers of the Commissioned Corps of the United States Public Health Service for 225 years of work protecting, promoting, and advancing the health and safety of the United States; Sponsor: Wyden, Ron [Sen.-D-OR]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.3385 – A bill to prohibit contracting with certain biotechnology providers; Sponsor: Hagerty, Bill [Sen.-R-TN]; Committees: Senate – Homeland Security and Governmental Affairs

 

S.3387 – A bill to direct the Secretary of Health and Human Services to update and clarify its rule on substances generally recognized as safe and to establish within the Food and Drug Administration the Office of Food Chemical Safety, Dietary Supplements, and Innovation, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3388 – A bill to amend the Public Health Service Act to authorize grants to States, Indian Tribes, Tribal organizations, and political subdivisions thereof to hire, employ, train, and dispatch mental health professionals to respond in lieu of law enforcement officers in emergencies involving one or more persons with a mental illness or an intellectual or developmental disability, and for other purposes; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3393 – A bill to reauthorize the SUPPORT for Patients and Communities Act, and for other purposes; Sponsor: Sanders, Bernard [Sen.-I-VT]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6571 – To establish a critical supply chain resiliency and crisis response program in the Department of Commerce, and to secure American leadership in deploying emerging technologies, and for other purposes; Sponsor: Bucshon, Larry [Rep.-R-IN-8]; Committees: House – Energy and Commerce

 

S.3394 – A bill to amend title XVIII of the Social Security Act to expand the eligibility for designation as a rural emergency hospital under the Medicare program; Sponsor: Moran, Jerry [Sen.-R-KS]; Committees: Senate – Finance

 

S.3398 – A bill to amend the Public Health Service Act to establish an Office of Drug Manufacturing; Sponsor: Warren, Elizabeth [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3403 – A bill to amend title XVIII of the Social Security Act to establish a Medicare payment option for patients and eligible professionals to freely contract, without penalty, for Medicare fee-for-service items and services, while allowing Medicare beneficiaries to use their Medicare benefits; Sponsor: Paul, Rand [Sen.-R-KY]; Committees: Senate – Finance

 

S.3410 – A bill to prohibit the Secretary of Health and Human Services from finalizing a proposed rule regarding minimum staffing for nursing facilities, and to establish an advisory panel on the nursing home workforce; Sponsor: Fischer, Deb [Sen.-R-NE]; Committees: Senate – Finance

 

S.3411 – A bill to prohibit contracting with certain biotechnology providers; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Homeland Security and Governmental Affairs

 

H.R.6590 – To improve access to the Program of All-Inclusive Care for the Elderly, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6596 – To end the epidemic of gun violence and build safer communities by strengthening Federal firearms laws and supporting gun violence research, intervention, and prevention initiatives; Sponsor: Johnson, Henry C. “Hank,” Jr. [Rep.- D-GA-4]; Committees: House – Judiciary; Ways and Means; Energy and Commerce

 

H.R.6600 – To direct the Secretary of Health and Human Services to issue guidance on whether hospital emergency departments should implement fentanyl testing as a routine procedure for patients experiencing an overdose, and for other purposes; Sponsor: Lieu, Ted [Rep.-D-CA-36]; Committees: House – Energy and Commerce

 

H.R.6607 – To amend the Public Health Service Act to establish an Office of Drug Manufacturing; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce

 

S.3424 – A bill to reauthorize the program for strengthening communities of recovery for individuals with substance use disorders; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6635 – To prohibit the Department of Health and Human Services from treating pregnancy as an illness for purposes of approving abortion drugs; Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House – Energy and Commerce

 

H.R.6636 – To ensure that women seeking an abortion are notified, before giving informed consent to receive an abortion, of the medical risks associated with the abortion procedure and the major developmental characteristics of the unborn child; Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House – Energy and Commerce

 

S.3430 – An original bill to amend titles XVIII and XIX of the Social Security Act to expand the mental health care workforce and services, reduce prescription drug costs, and extend certain expiring provisions under Medicare and Medicaid, and for other purposes; Sponsor: Wyden, Ron [Sen.-D-OR]; Committees: Senate – Finance

 

S.3437 – A bill to amend the Social Security Act to authorize grants and training to support area agencies on aging and other community-based organizations in addressing social isolation among older individuals and adults with disabilities; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Finance

 

S.3444 – A bill to amend the Communications Act of 1934 to improve the accessibility of 9-8-8, and for other purposes; Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Commerce, Science, and Transportation

 

S.3447 – A bill to reauthorize the program to support residential treatment programs for pregnant and postpartum women, and for other purposes; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3449 – A bill to provide low-income individuals with opportunities to enter and follow a career pathway in the health professions, and for other purposes; Sponsor: Heinrich, Martin [Sen.-D-NM]; Committees: Senate – Finance

 

S.3450 – A bill to amend title XVIII of the Social Security Act to establish a demonstration program to promote collaborative treatment of mental and physical health comorbidities under the Medicare program; Sponsor: Bennet, Michael F. [Sen.-D-CO];Committees: Senate – Finance

 

S.3451 – A bill to amend titles XIX and XXI of the Social Security Act to provide mental health and substance use services to incarcerated individuals, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Finance

 

S.3453 – A bill to establish a grant program to facilitate peer-to-peer mental health support programs for secondary school students, and for other purposes; Sponsor: Hickenlooper, John W. [Sen.-D-CO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3454 – A bill to prohibit the use of Federal funds to purchase at-home tests for SARS-CoV-2 from certain foreign entities; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6663 – To amend the SUPPORT for Patients and Communities Act to authorize the use of certain grants to prevent suicide or overdose by children, adolescents, and young adults, and for other purposes; Sponsor: Craig, Angie [Rep.-D- MN-2]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.6664 – To encourage innovation in the development of pediatric drugs, and for other purposes; Sponsor: Eshoo, Anna G. [Rep.-D-CA-16]; Committees: House – Energy and Commerce

 

H.R.6668 – To prohibit the use of Federal funds to purchase at-home tests for SARS-CoV-2 from certain foreign entities; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce

 

H.R.6673 – To amend the Controlled Substances Act to provide for a new rule regarding the application of the Act to marijuana, and for other purposes; Sponsor: Joyce, David P. [Rep.-R-OH-14]; Committees: House – Energy and Commerce; Judiciary; Transportation and Infrastructure

 

H.R.6674 – To provide for the periodic issuance of up-to-date clinical guidance on addressing the health effects of per- and polyfluoroalkyl substances (PFAS), and for other purposes; Sponsor: Kildee, Daniel T. [Rep.-D-MI-8]; Committees: House – Energy and Commerce

 

H.R.6675 – To amend titles XIX and XXI of the Social Security Act to provide mental health and substance use services to incarcerated individuals, and for other purposes; Sponsor: Kuster, Ann M. [Rep.-D-NH-2]; Committees: House – Energy and Commerce

 

H.R.6683 – To amend title XVIII of the Social Security Act to increase support for physicians and other practitioners in adjusting to Medicare payment changes; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce; Ways and Means

House to Consider Two Health Bills this Week

The House of Representatives is scheduled to vote on two health care related bills this week. The Testing, Rapid Analysis, and Narcotic Quality (TRANQ) Research Act (H.R. 1734), as amended by the Senate in June, would require the National Institute of Standards and Technology to support research and other activities related to identifying xylazine (a compound used in veterinary medicine as a nonopioid tranquilizer), novel synthetic opioids, and other new psychoactive substances. The Elizabeth Dole Home Care Act (H.R. 542) would expand community-based services for aging veterans and aims to improve VA support for veterans and caregivers of all ages. Both pieces of legislation are scheduled to be considered under suspension of the rules.

 

White House Announces New Steps to Strengthen Medical Supply Chains

President Joe Biden announced nearly 30 new actions to strengthen the nation’s critical supply chains last week, including the establishment of a White House Council on Supply Chain Resilience. As a part of this effort the President will issue a Presidential Determination broadening the U.S. Department of Health and Human Services’ (HHS) authorities under Title III of the Defense Production Act to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and other inputs essential to the national defense. HHS will also designate a new Supply Chain Resilience and Shortage Coordinator for efforts to strengthen the resilience of critical medical product supply chains, and to address related shortages.

 

FDA Chief Scientist to Succeed Woodcock at FDA

Namandjé N. Bumpus has been appointed to replace Janet Woodcock as principal deputy commission of the Food and Drug Administration (FDA) when Woodcock retires next year. Bumpus has served as chief scientist of the FDA since June 2022. During her tenure, she has played a key role in the agency’s decision to remove Makena, a medication for preventing premature birth, from the market due to safety concerns, as well as in the agency’s proposal to ban formaldehyde and formaldehyde-releasing chemicals in hair- straightening products marketed in the U.S. Prior to joining the FDA, Bumpus served as Professor and Chair of the Department of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine. Her research career focused on drug metabolism, pharmacogenetics, bioanalytical chemistry, and infectious disease pharmacology. Bumpus will be the first Black woman to serve as principal deputy commissioner at the FDA.

 

Warren, Blumenthal Probe Private Equity-Backed Anesthesia Practice

Sens. Elizabeth Warren (D-Mass.) and Richard Blumenthal (D-Conn.) have sent a letter to U.S. Anesthesia Partners (USAP) raising concerns about reports that USAP is engaging in anticompetitive practices that are reducing patients’ quality of care, increasing prices, and suppressing worker wages. The letter cites an investigation by The Washington Post which found that the private equity (PE) backers of USAP have engaged in a series of small acquisitions to consolidate market power and then use “anticompetitive tactics to maintain its advantage – including restrictive non-compete agreements to prevent physicians from working for other practices in the area, cutting off choices for patients.” The lawmakers assert that USAP “is emblematic of the long-standing problems associated with PE’s involvement in our health care system,” and request a response from USAP by December 11.

 

Fauci to Appear Before Congressional Coronavirus Panel

Former White House medical adviser Anthony Fauci has agreed to testify before the House Select Subcommittee on the Coronavirus Pandemic in January regarding his role in the nation’s response to the COVID-19 pandemic. Fauci will be interviewed by the panel January 8-9 for seven hours per day. “Dr. Fauci was the face of America’s public health response during the COVID-19 pandemic, and his testimony will serve as a crucial component of the Select Subcommittee’s investigations into the origin of COVID-19, coercive mandates, gain-of-function type research, scientific censorship, and more,” Subcommittee Chairman Brad Wenstrup (R-Ohio) said in a statement.

 

George Santos Expelled from the House

The House of Representatives voted to expel Rep. George Santos (R-N.Y.) last week in a 311-114 vote, with nearly half of the chamber’s GOP members supporting his expulsion. Santos becomes only the sixth House lawmaker to be expelled in U.S. history, and the first since former Rep. Jim Traficant (D-OH) was expelled in 2002 following a conviction on federal corruption charges. The Santos decision followed a House Ethics Committee investigation into the lawmaker which found substantial evidence that Santos violated federal criminal laws. Republicans can now only afford to lose three members on party-line votes due to their slim majority. New York Governor Kathy Hochul (D) will call a special election to fill Santos’ seat within the next three months, with party committees nominating candidates to fill the vacancy. Former Rep. Tom Suozzi is one of several Democrats who have declared their intention to run for the seat in the regular 2024 election.

 

A running list of other members of Congress who are retiring, vacating office, or seeking another office can be found below.


 

Upcoming Congressional Hearings and Markups

Senate Finance Committee hearing “Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective;” 10:00 a.m.; December 5

 

House Energy and Commerce Committee markup of 44 pieces of legislation; December 5

 

House Oversight and Accountability Subcommittee on Cybersecurity, Information Technology, and Government Innovation hearing “White House Policy on AI;” 2:00 p.m.; December 6

 

House Veterans’ Affairs Subcommittee on Health hearing “Staff Sergeant Parker Gordon (SSG) Fox Suicide Prevention Grants: Saving Veterans’ Lives Through Community Connection;” 10:30 a.m.; December 12

 

Recently Introduced Health Legislation

S.Res.474 – A resolution designating November 2023 as American Diabetes Month; Sponsor: Shaheen, Jeanne [Sen.-D- NH]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.478 – A resolution designating November 2023 as “National Hospice and Palliative Care Month”; Sponsor: Rosen, Jacky [Sen.-D-NV]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

H.R.6483 – To amend the Public Health Service Act to require greater transparency and accountability within the grant- making process of the National Institutes of Health; Sponsor: Huizenga, Bill [Rep.-R-MI-4]; Committees: House – Energy and Commerce

 

H.R.6484 – To amend title XIX of the Social Security Act to ensure health insurance coverage continuity for former foster youth; Sponsor: Kamlager-Dove, Sydney [Rep.-D-CA-37]; Committees: House – Energy and Commerce

 

H.R.6487 – To amend title XI of the Social Security Act to prohibit health plans from imposing fees on health care providers for electronic funds transfers and health care payment and remittance advice transactions, and for other purposes; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce; Ways and Means.

 

H.R.6490 – To amend title XVIII of the Social Security Act to limit the penalty for late enrollment under part B of the Medicare Program to 15 percent and twice the period of no enrollment, and to exclude periods of COBRA, retiree, and VA coverage from such late enrollment penalty; Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House – Energy and Commerce; Ways and Means

 

S.Res.480 – A resolution recognizing November 2023 as “National Family Caregivers Month”; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.481 – A resolution expressing support for the goals of Stomach Cancer Awareness Month; Sponsor: Young, Todd [Sen.-R-IN]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

S.Res.482 – A resolution commemorating and supporting the goals of World AIDS Day; Sponsor: Booker, Cory A. [Sen.- D-NJ]; Committees: Senate – Foreign Relations

 

S.3364 – A bill to amend the SUPPORT for Patients and Communities Act to authorize the use of certain grants to prevent suicide or overdose by children, adolescents, and young adults, and for other purposes; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3370 – A bill to reauthorize the program on prenatal and postnatal health of the Centers for Disease Control and Prevention; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3374 – A bill to waive General Schedule qualification standards related to work experience for nurses at military medical treatment facilities, and for other purposes; Sponsor: Murray, Patty [Sen.-D-WA]; Committees: Senate – Homeland Security and Governmental Affairs

 

S.3383 – A bill to reform the Centers for Disease Control and Prevention, limit the scope of public health authorities, and for other purposes; Sponsor: Schmitt, Eric [Sen.-R-MO]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.897 – Expressing support for the goals of November National Lung Cancer Awareness Month and for the early detection and treatment of lung cancer; Sponsor: Boyle, Brendan F. [Rep.-D-PA-2]; Committees: House – Energy and Commerce

 

H.Res.898 – Recognizing November 2023 as “National Family Caregivers Month”; Sponsor: Evans, Dwight [Rep.-D- PA-3]; Committees: House – Education and the Workforce; Energy and Commerce; Ways and Means

 

H.Res.899 – Recognizing the Suicide Awareness and Remembrance Flag; Sponsor: Garbarino, Andrew R. [Rep.-R-NY-2]; Committees: House – Armed Services; Veterans’ Affairs

 

H.R.6519 – To amend the Federal Food, Drug, and Cosmetic Act to ban the use of intentionally added perfluoroalkyl or polyfluoroalkyl substances in cosmetics, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

 

H.R.6533 – To amend title XIX of the Social Security Act to require a Federal medical assistance percentage of 100 percent for urban Indian organizations, and for other purposes; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce

 

H.R.6534 – To establish a home-based telemental health care demonstration program for purposes of increasing mental health and substance use services in rural medically underserved populations and for individuals in farming, fishing, and forestry occupations; Sponsor: Salinas, Andrea [Rep.-D-OR-6]; Committees: House – Energy and Commerce

 

H.R.6537 – To waive General Schedule qualification standards related to work experience for nurses at military medical treatment facilities, and for other purposes; Sponsor: Strickland, Marilyn [Rep.-D-WA-10]; Committees: House – Armed Services

Arrington, Burgess Question CBO About Drug Development Analysis

House Budget Committee Chairman Jodey Arrington (R-Texas) and Budget Committee Health Care Task Force Chair Michael Burgess (R-Texas) have sent a letter to the Congressional Budget Office (CBO) regarding CBO’s process for analyzing the impact of policy proposals on U.S. drug development. The lawmakers specifically inquire about CBO’s review of the drug pricing provisions contained in last year’s Inflation Reduction Act (IRA). The letter points out that while CBO’s analysis suggested that the IRA would result in a total of 13 fewer drugs coming to market over the next 30 years, independent assessments and related studies have suggested that number is significantly higher. “With the growing impact of health spending on the federal budget, we appreciate that CBO recognizes the power of innovation to reduce health care costs,” the letter states. “Accordingly, it is increasingly important that CBO’s analysis of policies that impact drug development in the U.S is incorporating the latest and most accurate information to ensure policymakers are fully aware of the impact legislation will have on patient access to new drugs.”

 

Oversight Panel to Probe FTC’s Handling of Amgen Merger

House Oversight Committee Chairman James Comer (R-Ky.) has launched an investigation into the Federal Trade Commission’s (FTC) protection of confidential corporate information. Comer highlighted the FTC’s apparent misuse of confidential information in the premerger process of Amgen’s merger with Horizon Therapeutics. “Left unaddressed, these actions could have a chilling effect on the willingness of companies to engage the Commission in non-adversarial reviews of proposed mergers thereby creating more resource- intensive litigation paid for by taxpayers,” Comer states.

 

AHA Urges CMS to Address MA Plan Violations

The American Hospital Association has sent a letter to the Centers for Medicare and Medicaid Services (CMS) expressing concerns about Medicare Advantage organizations’ (MAO) compliance with Medicare Advantage (MA) coverage regulations. The letter provides examples of plan practices that circumvent the requirements detailed in the calendar year 2024 MA final rule and expresses concerns that these practices “will result in the maintenance of the status quo where MAOs apply their own coverage criteria that is more restrictive than Traditional Medicare proliferating the very behavior that CMS sought to address in the final rule, resulting in inappropriate denials of medically necessary care and disparities in coverage between beneficiaries in MA and those in the Traditional Medicare program.” AHA urges CMS to:

  • Clarify that coverage criteria for inpatient admissions are fully established under Traditional Medicare;
  • Clarify that the flexibility for MA plans to supplement Traditional Medicare rules with additional internal coverage criteria is not applicable for medical necessity reviews of inpatient admissions and level of care decisions and should only be used in certain limited circumstances;
  • Reinforce expectations to MAOs and confirm MAO compliance with public accessibility and evidentiary standards for internal coverage criteria; and
  • Take swift action to correct MA plan policies that do not comply with CMS rules.

 

Congress Retirements and Resignations

Several more lawmakers have added their names to the group of individuals who will not be returning to their elected positions next Congress:

  • Rep. Tony Cardenas (D-Calif.) will retire from Congress at the end of his current term. Cardenas was first elected to the House of Representatives in 2012, and currently serves as a member of the Energy and Commerce Committee.
  • Rep. Anna Eshoo (D-Calif.) also announced plans to retire. Eshoo currently serves as the top Democrat on the Energy and Commerce Subcommittee on Health. During her more than three decades in Congress, Eshoo has played a key role in the development of health care policy. She sponsored the bills that led to the creation of the Biomedical Advanced Research and Development Authority and the Advanced Research Projects Agency for Health. She was also a champion of the original Pandemic and All Hazards Preparedness Act.
  • Rep. Bill Johnson (R-Ohio) will not seek reelection in 2024. He announced last week that he has accepted an offer to become the new president of Youngstown State University. He will continue serving in the House “for several more months.” Johnson is a member of the Energy and Commerce Committee.
  • Rep. Dean Phillips (D-Minn.) will not seek reelection to Congress amidst his 2024 presidential campaign. Phillips was first elected to Congress in 2018 and is a member of the House Problem Solvers Caucus. He has pitched himself as a younger alternative to President Joe Biden in his presidential primary challenge.

A running list of members of Congress who are retiring or seeking other office can be found below.

 

Upcoming Congressional Hearings and Markups

Senate Judiciary Committee hearing “The Gun Violence Epidemic: A Public Health Crisis;” 10:00 a.m.; November 28

 

House Energy and Commerce Subcommittee on Health hearing “Understanding How AI is Changing Health Care;” 10:30 a.m.; November 29

 

House Energy and Commerce Subcommittee on Oversight and Investigations hearing “Unmasking Challenges CDC Faces in Rebuilding Public Trust Amid Respiratory Illness Season;” 10:00 a.m.; November 30

 

Recently Introduced Health Legislation

H.Res.874 – Expressing support for the designation of “Prematurity Awareness Month”. Sponsor: McClellan, Jennifer L. [Rep.-D-VA-4]; Committees: House – Energy and Commerce

 

H.Con.Res.77 – Expressing support for the designation of the week of November 13 through November 19, 2023, as “National Caregiving Youth Week” to raise awareness and encourage national recognition of children and adolescents under 18 years of age who serve as a primary or secondary caregiver for family or household members. Sponsor: Frankel, Lois [Rep.-D-FL-22]; Committees: House – Education and the Workforce

 

H.R.6445 – To amend title XVIII of the Social Security Act to improve coverage of audiology services under the Medicare program, and for other purposes. Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6451 – To amend the Public Health Service Act to authorize grants to States, Indian Tribes, Tribal organizations, and political subdivisions thereof to hire, employ, train, and dispatch mental health professionals to respond in lieu of law enforcement officers in emergencies involving one or more persons with a mental illness or an intellectual or developmental disability, and for other purposes. Sponsor: Porter, Katie [Rep.-D-CA-47]; Committees: House – Energy and Commerce; Judiciary

 

H.Con.Res.78 – Expressing the sense of Congress that public health professionals should be commended for their dedication and service to the United States on Public Health Thank You Day, November 20, 2023; Sponsor: Wittman, Robert J. [Rep.-R-VA-1]; Committees: House – Energy and Commerce

 

H.R.6459 -To amend title XI of the Social Security Act to limit demonstration projects related to abortion under Medicaid and CHIP; Sponsor: Brecheen, Josh [Rep.-R-OK-2]; Committees: House – Energy and Commerce

 

H.R.6460 – To prohibit the Secretary of Health and Human Services from issuing, finalizing, implementing, or enforcing any rule or guidance to facilitate abortions or access to abortions for an unaccompanied alien child; Sponsor: Brecheen, Josh [Rep.-R-OK-2]; Committees: House – Judiciary

 

H.R.6461 – To ensure that claims for benefits under the Black Lung Benefits Act are processed in a fair and timely manner, to better protect miners from pneumoconiosis (commonly known as “black lung disease”), and for other purposes; Sponsor: Cartwright, Matt [Rep.-D-PA-8]; Committees: House – Education and the Workforce; Ways and Means

 

H.R.6465 – To amend title XVIII of the Social Security Act to provide a phase-in for plasma-derived products under the manufacturer discount program; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6475 – To provide for the designation of areas as Health Disparity Zones to reduce health disparities and improve health outcomes in such areas, and for other purposes; Sponsor: Thanedar, Shri [Rep.-D-MI-13]; Committees: House – Energy and Commerce; Ways and Means

Congress Extends Government Funding Through Early 2024

Congress passed a stopgap spending measure (H.R. 6363) last week that funds some parts of the federal government through January 19 and others through February 2. The “two-step” continuing resolution (CR) was passed by the House of Representatives on Tuesday, with 209 Democrats joining 127 Republicans voting in support of the measure. The temporary funding bill was then approved by the Senate on Wednesday in an 87-11 vote. President Joe Biden signed the agreement into law on Thursday, less than a day before existing funding was set to expire. The package extends appropriations for Military Construction-Veterans Affairs (VA), Transportation-Housing and Urban Development (HUD), Agriculture-Rural Development-Food and Drug Administration (FDA), and Energy-Water Development through January 19, while funding for the remaining eight appropriations measures, including the U.S. Department of Health and Human Services, extends through February 2. Congress faces an effective April 30 deadline to pass fiscal year 2024 appropriations, given that the most recent debt ceiling agreement included a provision to subject all discretionary spending to a 1% cut should a CR still be in place past that date. Speaker Johnson stated last week that it would be the last time he supports a short-term government funding measure.

 

The CR was passed as further progress on FY 2024 appropriations bills has stalled. House leadership postponed a vote on their Labor-Health and Human Services-Education spending bill (H.R. 5894) last week after failing to secure enough support for its passage. The bill includes steep funding cuts for domestic agencies, including the National Institutes of Health (NIH). The chamber has also failed to move the Agriculture-FDA, Financial Services, and Transportation- HUD spending bills. The Senate has passed only three of the 12 annual appropriations bills, covering Agriculture-FDA, Military Construction-VA, and Transportation-HUD. The Senate is scheduled to return from Thanksgiving break on November 27, and the House is expected to reconvene on November 28.

 

E&C Health Panel Advances 21 Bills

The House Energy and Commerce Subcommittee on Health advanced 21 bills last week. The bills under consideration were focused on lowering prescription drug costs, improving the Medicare program’s coverage process, and addressing laboratory and physician reimbursement issues. The following legislation was approved by voice vote:

  • H.R. 5372, Expanding Seniors’ Access to Lower Cost Medicines Act of 2023
  • H.R. 2880, Protecting Patients Against PBM Abuses Act
  • H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and
  • quality under Medicare part D, and for other purposes
  • H.R. 5385, Medicare PBM Accountability Act
  • H.R. 5386, Cutting Copays Act
  • H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program.
  • H.R. 5389, National Coverage Determination Transparency Act
  • H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act
  • H.R. 5396, Coverage Determination Clarity Act of 2023
  • H.R. 5371, Choices for Increased Mobility Act of 2023
  • H.R. 5388, Supporting Innovation for Seniors Act
  • H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage
  • H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023
  • H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023
  • H.R. 6366, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program, and to revise the phase-in of clinical laboratory test payment changes under such program
  • H.R. 6369, To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models
  • H.R. 6371, Provider Reimbursement Stability Act of 2023
  • H.R. 6364, Medicare Telehealth Privacy Act of 2023
  • H.R. 1352, Increasing Access to Biosimilars Act of 2023
  • H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act, was advanced 21-6. Several Democrats, including full Committee Ranking Member Frank Pallone (D-N.J.), expressed concerns that the proposal could undermine the Centers for Medicare and Medicaid Services’ process for determining whether a medical product is reasonable and necessary. Democrats also opposed the H.R. 5555, the DMEPOS Relief Act, which advanced 16-12. The bill would maintain the enhanced reimbursement rates for durable medical equipment instituted in response to the COVID-19 pandemic. Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) stated her intention to finalize offsets for the bills and technical assistance from federal agencies before full committee markup.

 

Warnock, Kennedy Report on Insulin Deserts

Sens. Raphael Warnock (D-Ga.) and John Kennedy (R-La.) released a report last week on the urgency of lowering the cost of insulin for all patients across the nation. The lawmakers have proposed to limit the out-of-pocket cost of insulin to $35 a month in the private insurance market and for the uninsured, similar to the insulin out-of-pocket cap for Medicare beneficiaries included in last year’s Inflation Reduction Act. The Congressional Budget Office estimates that the private insurance portion of the bill (S. 954) would cost $629 million over the next decade. The lawmakers point out that this price tag is significantly less than the $410 billion annual cost of diabetes. Warnock is pushing for a vote on the legislation by the end of the year.

 

Bipartisan Group Investigates Health Risks of Meta Platforms

Sens. Elizabeth Warren (D-Mass.), Richard Blumenthal (D-Conn.), Josh Hawley (R-Mo.), Dick Durbin (D-Ill.), and Marsha Blackburn (R-Tenn.) sent a letter to Mark Zuckerberg, CEO of Meta, requesting information related to the mental and physical health risks posed by his company’s products, including Facebook and Instagram. The lawmakers assert that Meta “concealed and misrepresented its extensive knowledge about the threats to young people on its platforms.”

 

Congressional Retirements

Rep. Michael Burgess, MD (R-Texas) announced that he will not seek reelection at the conclusion of his 11th term in Congress next year. Burgess is the second highest ranking Republican on both the House Energy and Commerce Committee and House Rules Committee. He served as the top Republican on the Energy and Commerce Health Subcommittee during both the 115th and 116th Congresses. Burgess also leads the House Budget Committee’s health care task force and is co-chair of the GOP Doctors Caucus. During his time on Capitol Hill, Burgess has focused on health policy issues and has been a champion of Medicare physician payment reform. “It has been the honor of my life to have gone from a small-town doctor delivering babies, with no prior political experience, to elected to represent my friends and neighbors in the United States Congress,” Burgess said in a statement. Several other lawmakers also announced their decisions to leave Congress in recent days:

  • Rep. Abigail Spanberger (D-Va.) is retiring from the House to run for governor of Virginia.
  • Rep. Dan Kildee (D-Mich.) will retire from Congress at the end of his term. Kildee is a member of the House Ways and Means Committee.
  • Rep. George Santos (R-N.Y.) will not seek reelection. The decision follows a recommendation from the House Ethics Committee chairman that Santos be expelled from the House. The panel released the results from an investigation into the lawmaker last week which found substantial evidence that Santos violated federal criminal laws.

A running list of members of Congress who are retiring or seeking other office can be found here.

 

Combined Senate/House 2024 Calendar

The Senate has released a tentative calendar for 2024. The chamber’s schedule includes a two-week Presidents’ Day recess, a two-week recess in late March and early April, another week in late April, two weeks around the Fourth of July, and a five-week August recess, along with an October recess ahead of the 2024 elections. The lame duck session will include two-weeks spent on Capitol Hill in November and another three in December. The combined House and Senate legislative calendar for next year can be found here.

 

Senior FDA Regulator Woodcock to Retire

Janet Woodcock, Principal Deputy Commissioner at the FDA, has announced her plans to retire early next year after nearly four decades at the agency. During her time at the FDA, Woodcock has overseen the approval of numerous critical medical treatments, and played a central role in the government’s pandemic response through her work on COVID-19 therapeutics. Woodcock has also been a strong proponent of reforming the clinical trial system. FDA Commissioner Robert Califf called her “a legend in every sense of the word,” highlighting her “indelible mark” on public health. Woodcock has also been the subject of some controversy in recent years, centering on her role in the opioid epidemic as well her support for the approval of the Alzheimer’s drug Aduhelm and a Duchenne muscular dystrophy drug despite opposition from other agency officials.

 

President Appoints New NCI Director

The White House has appointed W. Kimryn Rathmell, MD, PhD to serve as the next director of the National Cancer Institute. Rathmell succeeds Monica Bertagnolli, who was recently confirmed by the Senate to lead the NIH. Dr. Rathmell is an oncologist and kidney cancer expert who heads the Vanderbilt University Medical Center. She has held key leadership positions at the American Society of Clinical Oncology, the Kidney Cancer Research Foundation, and the American Society for Clinical Investigation.

 

White House Initiative on Women’s Health Research

The White House announced the establishment of an initiative focused on women’s health research last week. The initiative will be led by First Lady Jill Biden, alongside the White House Gender Policy Council, and chaired by Carolyn Mazure, Yale School of Medicine professor of women’s health research, psychiatry, and psychology. It will direct multiple federal agencies to issue recommendations to advance women’s health research within 45 days. The initiative will also engage with the private and philanthropic sectors to identify areas for additional investment.

 

Speaker Johnson Hires New Health Staffer

Drew Keyes has been hired as Senior Policy Advisor for the office of House Speaker Mike Johnson (R-La.). Keyes most recently worked as a senior policy analyst at Paragon Health Institute. Keyes previously served as a professional policy staffer for the Republican Study Committee (RSC), where he was the staff lead for the RSC’s Health Care Task Force. Keyes got his start on Capitol Hill in the offices of Reps. Louie Gohmert (R-Texas) and Tom McClintock (R-Calif.).

 

Recently Introduced Health Legislation

S.3290 – A bill to amend title 38, United States Code, to modify the authority of the Secretary of Veterans Affairs to furnish improvements and structural alterations as part of home health services for disabled veterans; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Veterans’ Affairs

 

H.Res.867 – Expressing support for the designation of November 9, 2023, as “National Microtia and Atresia Awareness Day”; Sponsor: Neguse, Joe [Rep.-D-CO-2]; Committees: House – Energy and Commerce

 

H.R.6364 – To amend title XVIII of the Social Security Act to maintain certain telehealth flexibilities relating to provider privacy under the Medicare program; Sponsor: Balderson, Troy [Rep.-R-OH-12]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6366 – To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program, and to revise the phase-in of clinical laboratory test payment changes under such program; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6369 – To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models; Sponsor: Schrier, Kim [Rep.-D-WA-8]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6371 – To provide for certain adjustments to the physician fee schedule under the Medicare program; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6373 – To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to offer annual preventative health evaluations to veterans with a spinal cord injury or disorder and increase access to assistive technologies, and for other purposes; Sponsor: Bergman, Jack [Rep.-R-MI-1]; Committees: House – Veterans’ Affairs

 

H.R.6374 – To provide for the issuance of a Veterans Health Care Stamp; Sponsor: Burgess, Michael C. [Rep.-R-TX-26]; Committees: House – Oversight and Accountability; Veterans’ Affairs

 

H.R.6388 – To authorize the Secretary of Health and Human Services, acting through the Administration for Community Living, to carry out a grant program for States to provide telephone reassurance services to certain older adults and to other adults with disabilities, and for other purposes; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce

 

S.3297 – A bill to amend title XVIII of the Social Security Act to expand the availability of medical nutrition therapy services under the Medicare program; Sponsor: Collins, Susan M. [Sen.-R-ME]; Committees: Senate – Finance

 

H.Res.870 – Supporting the goals and ideals of National Rural Health Day; Sponsor: Harshbarger, Diana [Rep.-R-TN-1]; Committees: House – Energy and Commerce

 

H.R.6395 – To amend the Energy Act of 2020 to require the Secretary of the Interior to include the Secretary of Health and Human Services in consultations regarding designations of critical minerals, elements, substances, and materials; Sponsor: Curtis, John R. [Rep.-R-UT-3]; Committees: House – Natural Resources

 

H.R.6400 – To amend title XVIII of the Social Security Act to extend eligibility for certain payment increases for biosimilar biological products under the Medicare program; Sponsor: Cárdenas, Tony [Rep.-D-CA-29]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6403 – To amend the General Education Provisions Act to require the disclosure of student medical and counseling records to parents; Sponsor: Gaetz, Matt [Rep.-R-FL-1]; Committees: House – Education and the Workforce

 

H.R.6407 – To amend title XVIII of the Social Security Act to expand the availability of medical nutrition therapy services under the Medicare program; Sponsor: Kelly, Robin L. [Rep.-D-IL-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6412 – To amend title XXVII of the Public Health Service Act to provide certain informational resources related to Down syndrome; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce

 

H.R.6415 – To increase access to mental health, substance use, and counseling services for first responders, and for other purposes; Sponsor: Tokuda, Jill N. [Rep.-D-HI-2]; Committees: House – Energy and Commerce; Transportation and Infrastructure

 

S.3304 – A bill to ensure that claims for benefits under the Black Lung Benefits Act are processed in a fair and timely manner, to better protect miners from pneumoconiosis (commonly known as “black lung disease”), and for other purposes; Sponsor: Casey, Robert P., Jr. [Sen.-D-PA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3307 – A bill to amend title XVIII of the Social Security Act to require the inclusion of certain information in encounter data under Medicare Advantage; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Finance

 

S.3311 – A bill to direct the Secretary of Health and Human Services to conduct a demonstration program to test providing preferential treatment under the Medicare, Medicaid, and CHIP programs for certain drugs and biologicals manufactured in the United States; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Finance

 

S.3312 – A bill to provide a framework for artificial intelligence innovation and accountability, and for other purposes; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Commerce, Science, and Transportation

 

S.3326 – A bill to improve access to opioid use disorder treatment services under the Medicare program; Sponsor: Collins, Susan M. [Sen.-R-ME]; Committees: Senate – Finance

 

S.3327 – A bill to require the Secretary of Health and Human Services to publish a list of hospitals found to be in noncompliance with the hospital price transparency rule; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3330 – A bill to require the Secretary of Labor to conduct a study on the fiduciary duties of pharmacy benefit managers; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3337 – A bill to establish national data privacy standards in the United States, and for other purposes; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Commerce, Science, and Transportation

 

S.Res.470 – A resolution designating November 16th, 2023, as “National Rural Health Day”; Sponsor: Barrasso, John [Sen.-R-WY]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

 

H.R.6424 – To provide additional authorities for the leadership of the United States Agency for International Development in health technology innovation for global health in low-resource settings, and for other purposes; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Foreign Affairs

 

H.R.6428 – To help individuals receiving disability insurance benefits under title II of the Social Security Act obtain rehabilitative services and return to the workforce, and for other purposes; Sponsor: Hill, J. French [Rep.-R-AR-2]; Committees: House – Ways and Means

 

H.R.6430 – To amend title XVIII of the Social Security Act to extend Medicare-dependent hospital and Medicare low- volume hospital payments, and to direct the Comptroller General of the United States to carry out a report on Medicare rural hospital classifications; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House – Ways and Means

 

H.R.6433 – To preserve access to emergency medical services; Sponsor: Perez, Marie Gluesenkamp [Rep.-D-WA-3]; Committees: House – Energy and Commerce; Education and the Workforce

House Speaker Reveals 2-Step Plan to Avert Government Shutdown

House Speaker Mike Johnson (R-La.) plans to pursue a stopgap spending measure that would fund some parts of the federal government through January 19 and others through February 2. Under this “two-step continuing resolution (CR),” appropriations for Military Construction-Veterans Affairs, Transportation-Housing and Urban Development, Agriculture-Rural Development-Food and Drug Administration, and Energy-Water Development would be extended through January 19, while funding for the remaining eight appropriations measures would face the later deadline. The stopgap would not include any supplemental funding. Johnson is aiming to avoid “the absurd holiday-season omnibus tradition of massive, loaded up spending bills introduced right before the Christmas recess.” His plan, however, was received with some internal criticism, with conservative Rep. Chip Roy (R-Texas) expressing opposition to a clean CR that does not include additional spending cuts and policy riders. The House GOP can only afford four defections on a party-line vote. Lawmakers face a deadline of November 17 to fund the federal government and avoid a government shutdown when the current CR expires.

 

Senate Confirms Monica Bertagnolli as NIH Director

The Senate confirmed Monica Bertagnolli, M.D. as director of the National Institutes of Health (NIH) in a 62-36 vote last week. Nearly every Democrat joined 13 Republicans in support of her nomination. Sens. Bernie Sanders (I-Vt.) and John Fetterman (D-Pa.) were the only members of the Democratic caucus to vote no, with Fetterman echoing concerns previously voiced by Sanders that Bertagnolli is not “prepared to take on the greed and power of the drug companies.” Bertagnolli becomes the second woman to serve as permanent head of the medical research agency. She replaces principal deputy director Lawrence Tabak, D.D.S. who has worked as NIH acting director since the departure of long-time director Francis Collins, M.D. nearly two years ago. Bertagnolli is an oncologist who most recently served as the director of the National Cancer Institute.

 

Senate Finance Advances Mental Health, PBMs, Medicare Physician Fee Schedule Relief Extension Package

The Senate Finance Committee unanimously advanced the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act last week. The bill would mitigate the impending Medicare physician fee schedule cut by extending the relief from last year at the 2.5% level, rather than letting it drop to 1.25%. The package would expand eligibility for workforce shortage incentive programs for mental health and substance use disorder clinicians, support the use of licensed clinical social workers in the Medicare program, and require Medicare Advantage plans to have up-to-date and accurate provider directories. Additionally, the draft would mandate that prescription drug plan sponsors with preferred pharmacy networks have a minimum share of in-network pharmacies in underserved areas not tied to a pharmacy benefit manager or the sponsor. The bill also directs the U.S. Department of Health and Human Services to collect data on drug acquisition costs, and would require plans to include certain discount-eligible drugs in their formularies.

 

Finance Leadership Requests Artificial Intelligence Briefing

Senate Finance Committee Chairman Ron Wyden (D-Ore.) and Ranking Member Mike Crapo (R-Idaho) have sent a letter to the U.S. Department of Health and Human Services requesting staff briefings to learn more about how the department plans to adapt to the evolving artificial intelligence (AI) landscape. The lawmakers ask about any existing gaps in regulatory authority and about how the Centers for Medicare and Medicaid Services will monitor application of AI in the Medicare, Medicare Advantage, and Medicaid programs. “As agencies, providers, manufacturers, and insurers scale up their adoption of these types of tools across diverse health care settings,” the letter states, “the Senate Finance Committee seeks to strengthen our understanding of the relevant regulatory and statutory landscape, as well as engage on plans for adapting as the technology evolves.”

 

HELP Chair Continues Push for Reasonable Pricing and Access Standards

Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) sent a letter to Ambassador Pamela Hamamoto urging her to push for the inclusion of reasonable pricing and access standards in the new World Health Organization Pandemic Accord. “The U.S. should champion including reasonable pricing and technology sharing requirements into all funding agreements with pharmaceutical companies,” Sanders argues. “That is not just the right thing to do. It is the smart thing to do to protect the American people from viruses that respect no borders.”

 

Warren Comments on Amgen Acquisition of Horizon Therapeutics

Sen. Elizabeth Warren (D-Mass.) has sent a letter to the Federal Trade Commission (FTC) Chair Lina Khan expressing her disappointment with the agency’s decision to allow Amgen’s acquisition of Horizon Therapeutics to move forward. She expresses concerns about the potential impact of the merger on the price and availability of medicine. The letter urges the FTC to “vigorously challenge consolidation and anticompetitive behavior in the health care industry, consistent with its proposed merger guidelines.”

 

Congressional Retirements

Sen. Joe Manchin (D-W.Va.) has announced that he will not run for reelection next year. Manchin has served in the Senate since 2010. He currently sits on the Appropriations Committee and the Committee on Veterans’ Affairs. Manchin’s decision complicates Democrats’ hope to hold on to the Senate majority in 2025. Democrats and Democrat- aligned independents currently only hold a 51-seat majority in the chamber, and nearly all competitive seats up for reelection next year are held by Democrats. West Virginia Governor Jim Justice, who switched parties in 2017, and Rep. Alex Mooney (R-W.Va.) are running for the GOP nomination for Manchin’s Senate seat.

 

In the House, Rep. Brad Wenstrup, D.P.M. (R-Ohio) announced last week that he will be retiring from Congress at the end of next year. Wenstrup has served in Congress since 2013. He currently sits on the House Ways and Means Committee and is chairman of the Select Subcommittee on the Coronavirus Pandemic and co-chair of the GOP Doctors Caucus. Rep. Derek Kilmer (D-Wash.), House Appropriations Committee member, also announced that he will not seek reelection next year. Wenstrup and Kilmer join nearly two dozen other members of Congress who have already announced their plans to retire or seek other offices in 2024. Additionally, Rep. Brian Higgins (D-N.Y.) announced that after serving 19 years in the House, he will resign in February. He serves on the House Ways and Means Committee and Budget Committee. He also co-chairs the Bipartisan Cancer Caucus.

 

Ways and Means Republicans Criticize NSA Implementation

Republicans on the House Ways and Means Committee have sent a letter to the Biden administration criticizing its implementation of the No Surprises Act (NSA). The letter expresses concerns that some patients still receive a balance bill following the independent dispute resolution (IDR) process, and urges agencies to enforce the patient protections established by the law. But even worse, the letter states, are the “challenges when grouping IDR claims, the growing backlog of cases, and cases in which large health insurers fail to pay medical providers any amount after arbitration combine to place a significant financial burden on medical providers, forcing them to reduce available staff and services for patients.” The lawmakers also highlight the administration’s failure to issue rulemaking on the advanced explanation of benefits provision of the law.

 

E&C Republicans Probe SAMHSA Expenditures

House Energy and Commerce Committee Republicans have sent a “final notice” to the Substance Abuse and Mental Health Services Administration (SAMHSA) informing Administrator Miriam E. Delphin-Rittmon, Ph.D. that they will issue a subpoena if she fails to provide requested accounting details about how SAMHSA spent COVID-19 related supplemental money and 9-8-8 crisis care funding. The lawmakers are seeking “to get full accountability for SAMHSA funds,” stating that the agency “has repeatedly not provided requested information about expenditures, nor have any legal reasons been provided for not yet providing the requested information and documents.” Dr. Delphin-Rittmon is asked to produce the requested documents by November 27, 2023.

 

House Releases 2024 Legislative Calendar

House Majority Leader Steve Scalise (R-La.) released the chamber’s schedule for calendar year 2024 last week. The House’s schedule for the second session of the 118th Congress has 113 legislative days. It features similar recesses to prior years, including two weeks in February and the month of August, along with a week off in July for the Republican National Convention. The House plans to recess all October ahead of the 2024 elections and is scheduled to return after Veterans Day for a lame duck session. The Senate has not yet released its 2024 calendar.

 

House GOP Leadership Update

Rep. Blake Moore (R-Utah) has been elected the new vice chair of the House Republican Conference. He will fill the position formerly held by the new Speaker of the House Mike Johnson (R-La.). Moore was first elected to the House of Representatives in 2020 And currently serves on the Ways and Means and Budget committees. The role of conference vice chair is one of seven elected leadership positions in the House GOP and is responsible for focusing on political messaging.

 

President Acts to Expand Veterans’ Health Care Coverage

The White House announced several changes that will expand health care coverage for the nation’s veterans. Beginning this month, all living World War II veterans will be able to access health care services, including nursing home care, from the Department of Veterans Affairs at no cost. The administration will also work to accelerate PACT Act enrollment for veterans applying for benefits following exposure to toxic substances in the line of duty.

 

CMS Issues 2025 MA, Part D Proposed Rule

The Centers for Medicare and Medicaid Services has released its contract year 2025 policy and technical changes to the Medicare Advantage (MA) Plan Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE), and Health Information Technology Standards proposed rule. The regulation proposes new guardrails for plan compensation to agents and brokers to stop anti-competitive steering, and would fix the amount they can be paid per enrollee – regardless of the plan the beneficiary enrolls in – at $642. The current cap is $611. The rule would also prohibit MA plan organizations from contracting with third-party marketers that offer volume-based bonuses for enrollment into certain plans. CMS expresses concerns that such contract terms may interfere with the ability of agents or brokers to assist enrollees in finding the plan that is best suited to their needs. A fact sheet on the proposed rule can be found here.

 

Upcoming Congressional Hearings and Markups

House Rules Committee meets on H.R. 5894, the Labor, Health and Human Services, Education, and Related Agencies Appropriations Act, 2024; 4:00 p.m.; November 13

 

House Veterans’ Affairs Subcommittee on Health hearing “Emerging Therapies: Breakthroughs in the Battle Against Suicide?” 2:00 p.m.; November 14

 

Senate Finance Subcommittee on Health Care hearing “Ensuring Medicare Beneficiary Access: A Path to Telehealth Permanency;” 2:30 p.m.; November 14

 

Senate Foreign Relations Committee hearing “U.S. Leadership on Artificial Intelligence in an Era of Strategic Competition;” 10:00 a.m.; November 15

 

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: System Uptime;” 12:00 p.m.; November 15

 

Recently Introduced Health Legislation

H.R.6230 – To prohibit group health plans, health insurance issuers, and Federal health care programs from applying prior authorization requirements, utilization management techniques, and medical necessity reviews. Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House – Energy and Commerce; Oversight and Accountability

 

H.R.6227 – To amend the Federal Food, Drug, and Cosmetic Act to expand the tropical disease product priority review voucher program to encourage prevention and treatment of coccidioidomycosis. Sponsor: Schweikert, David [Rep.-R- AZ-1]; Committees: House – Energy and Commerce

 

S.3227 – A bill to amend the Internal Revenue Code of 1986 to provide an alternative manner of furnishing certain health insurance coverage statements to individuals; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

H.R.6243 – To direct the Secretary of Labor to issue an occupational safety and health standard that requires employers to keep opioid overdose reversal drugs onsite and develop and implement training plans to respond to drug overdose emergencies and to amend the Omnibus Crime Control and Safe Streets Act of 1968 to expand the grants authorized under the Comprehensive Opioid Abuse Grant Program; Sponsor: Gallego, Ruben [Rep.-D-AZ-3]; Committees: House – Education and the Workforce; Judiciary

 

H.R.6251 – To establish a grant program to provide schools with opioid overdose reversal drugs, to direct schools receiving Federal funds to report to certain Federal information systems any distribution of an opioid overdose reversal drug, and for other purposes; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Energy and Commerce; Education and the Workforce

 

S.3233 – A bill to amend title XVIII of the Social Security Act to reduce the occurrence of diabetes in Medicare beneficiaries by extending coverage under Medicare for medical nutrition therapy services to such beneficiaries with pre- diabetes or with risk factors for developing type 2 diabetes; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Finance

 

S.3236 – A bill to amend title XVIII of the Social Security Act to provide Medicare coverage of ambulance services that do not include transportation; Sponsor: Welch, Peter [Sen.-D-VT]; Committees: Senate – Finance

 

S.3244 – A bill to amend the Medicare Improvements for Patients and Providers Act of 2008 to extend funding outreach and assistance for low-income programs; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

S.3245 – A bill to amend title XIX of the Social Security Act to require the Secretary of Health and Human Services to conduct surveys of non-retail pharmacy drug prices, and for other purposes; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

H.R.6257 – To amend title XVIII of the Social Security Act to provide Medicare coverage of ambulance services that do not include transportation; Sponsor: Balint, Becca [Rep.-D-VT-At Large]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6258 – To amend the Child Abuse Prevention and Treatment Act to disqualify any State that discriminates against parents or guardians who oppose medical, surgical, pharmacological, psychological treatment, or clothing and social changes related to affirming the subjective claims of gender identity expressed by any minor if such claimed identity is inconsistent with such minor’s biological sex from receiving funding under such Act; Sponsor: Banks, Jim [Rep.-R-IN-3]; Committees: House – Education and the Workforce

 

H.R.6270 – To amend title I of the Patient Protection and Affordable Care Act to authorize the establishment of, and provide support for, State-based universal health care systems that provide comprehensive health benefits to State residents, and for other purposes; Sponsor: Khanna, Ro [Rep.-D-CA-17]; Committees: House – Energy and Commerce; Ways and Means; Armed Services; Oversight and Accountability; Education and the Workforce

 

H.R.6275 – To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes; Sponsor: Perez, Marie Gluesenkamp [Rep.-D-WA-3]; Committees: House – Energy and Commerce; Judiciary

 

H.R.6279 – To amend the Internal Revenue Code of 1986 to allow certain wearable devices to be purchased using health savings accounts and other spending arrangements and reimbursement accounts; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House – Ways and Means

 

S.3254 – A bill to amend the Internal Revenue Code of 1986 to allow expenses for parents to be taken into account as medical expenses, and for other purposes; Sponsor: Rosen, Jacky [Sen.-D-NV]; Committees: Senate – Finance

 

S.3258 – A bill to amend title XVIII of the Social Security Act to provide coverage of ALS-related services under the Medicare program for individuals diagnosed with amyotrophic lateral sclerosis, and for other purposes; Sponsor: Coons, Christopher A. [Sen.-D-DE]; Committees: Senate – Finance

 

S.3259 – A bill to amend the Public Health Service Act to reauthorize and expand technical assistance and support for recovery community organizations and peer support networks, and for other purposes; Sponsor: Collins, Susan M. [Sen.- R-ME]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3260 – A bill to direct the Secretary of Health and Human Services to establish a working group to formulate recommendations for standardizing the measurements of loneliness and isolation, and for other purposes; Sponsor: Ricketts, Pete [Sen.-R-NE]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6283 – To improve services provided by pharmacy benefit managers; Sponsor: Miller-Meeks, Mariannette [Rep.- R-IA-1]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce; Oversight and Accountability

 

H.R.6284 – To direct the Secretary of Health and Human Services to establish a working group to formulate recommendations for standardizing the measurements of loneliness and isolation, and for other purposes; Sponsor: Flood, Mike [Rep.-R-NE-1]; Committees: House – Energy and Commerce

 

H.R.6288 – To amend the Federal Food, Drug, and Cosmetic Act to provide for a Pediatric Brain Tumor Real-World Data Registry Program, and for other purposes; Sponsor: Bera, Ami [Rep.-D-CA-6]; Committees: House – Energy and Commerce

 

H.R.6296 – To provide for an emergency increase in Federal funding to State Medicaid programs for expenditures on home and community-based services; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce

 

H.R.6301 – To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide for cost-sharing for oral anticancer drugs on terms no less favorable than the cost-sharing provided for anticancer medications administered by a health care provider; Sponsor: Grothman, Glenn [Rep.-R-WI-6]; Committees: House – Education and the Workforce

 

H.R.6302 – To amend title XXVII of the Public Health Service Act to establish requirements for the disclosure of certain information relating to health care sharing ministries, and for other purposes; Sponsor: Huffman, Jared [Rep.-D-CA-2]; Committees: House – Energy and Commerce

 

H.R.6305 – To amend title III of the Public Health Service Act to impose a limitation on regulations relating to the control of communicable diseases, and for other purposes; Sponsor: Luna, Anna Paulina [Rep.-R-FL-13]; Committees: House – Energy and Commerce; Rules

 

H.R.6310 – To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models under the Medicare program; Sponsor: Ruiz, Raul [Rep.-D-CA-25]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6313 – To amend title XVIII of the Social Security Act to improve the accuracy of geographic adjustment factors under the Medicare program and to permanently extend certain adjustments to such factors for certain localities, and for other purposes; Sponsor: Smith, Adrian [Rep.-R-NE-3]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6315 – To amend title 38, United States Code, to authorize the Secretary of Veterans Affairs to waive the requirement of certain veterans to make copayments for hospital care and medical services in the case of an error by the Department of Veterans Affairs, and for other purposes; Sponsor: Smucker, Lloyd [Rep.-R-PA-11]; Committees: House – Veterans’ Affairs

 

S.3282 – A bill to amend title 38, United States Code, to authorize the Secretary of Veterans Affairs to waive the requirement of certain veterans to make copayments for hospital care and medical services in the case of an error by the Department of Veterans Affairs, and for other purposes; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Veterans’ Affairs

 

S.3284 – A bill to amend title 38, United States Code, to modify the limitation on reimbursement for emergency treatment of amounts owed to a third party or for which the veteran is responsible under a health-plan contract; Sponsor: Blumenthal, Richard [Sen.-D-CT]; Committees: Senate – Veterans’ Affairs

 

H.Res.860 – Expressing support for raising awareness about the growing population of young adults living with chronic health conditions in the United States; Sponsor: Raskin, Jamie [Rep.-D-MD-8]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.6330 – To direct the Secretary of Veterans Affairs to carry out a pilot program to collect and analyze data regarding suicides and attempted suicides by veterans on the property of the Department of Veterans Affairs, and for other purposes; Sponsor: Crow, Jason [Rep.-D-CO-6]; Committees: House – Veterans’ Affairs

 

H.R.6331 – To require the Secretary of Veterans Affairs to establish a pilot program to furnish doula services to veterans; Sponsor: Davis, Donald G. [Rep.-D-NC-1]; Committees: House – Veterans’ Affairs

 

H.R.6333 – To amend title 38, United States Code, to modify the limitation on reimbursement for emergency treatment of amounts owed to a third party or for which the veteran is responsible under a health-plan contract; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Veterans’ Affairs

 

H.R.6338 – To direct the Secretary of Veterans Affairs to establish a pilot program for gynecologic cancer care coordination at the Department of Veterans Affairs, and for other purposes; Sponsor: Garcia, Sylvia R. [Rep.-D-TX-29]; Committees: House – Veterans’ Affairs

 

H.R.6340 – To direct the Under Secretary for Health of the Department of Veterans Affairs to provide certain information to Department of Veterans Affairs medical center staff and homelessness service providers regarding the Coordinated Entry program, and for other purposes; Sponsor: Harder, Josh [Rep.-D-CA-9]; Committees: House – Veterans’ Affairs

 

H.R.6344 – To amend titles XVIII and XIX of the Social Security Act to require providers of services and health maintenance organizations under the Medicare and Medicaid programs to provide for certain policies to be in place relating to do-not-resuscitate orders or similar physician’s orders for unemancipated minors receiving services; Sponsor: LaTurner, Jake [Rep.-R-KS-2]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6347 – To limit cost-sharing for prescription drugs, and for other purposes; Sponsor: Manning, Kathy E. [Rep.-D- NC-6]; Committees: House – Energy and Commerce

 

H.R.6353 – To direct the Secretary of Veterans Affairs to conduct a review on opioid overdose deaths among veterans, and for other purposes; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Veterans’ Affairs

 

H.R.6360 – To amend title 38, United States Code, to assign the highest priority status for hospital care and medical services provided through the Department of Veterans Affairs to veterans who are former prisoners of war; Sponsor: Walberg, Tim [Rep.-R-MI-5]; Committees: House – Veterans’ Affairs

Medicare Physician Fee Schedule Final Rule Published

CMS released the CY 2024 Physician Fee Schedule (PFS) final rule on November 2. According to CMS, the finalized CY 2024 PFS conversion factor is $32.74, a decrease of $1.15 or 3.37% relative to CY 2023. Also note that CMS finalized maintaining a Merit-Based Incentive Payment System (MIPS) performance threshold of 75 points for 2024, rather than increasing it to 82 points, as proposed, which would have made it more challenging for physicians to avoid a penalty in 2026.

 

FY 2024 Appropriations Update

While both the House and Senate are making progress on their respective fiscal year (FY) 2024 spending bills, appropriators have yet to open any bicameral discussions to reconcile the two chambers’ very different approaches to government funding. Congress currently faces a November 17 deadline to avoid a government shutdown. The House of Representatives has passed seven of the 12 annual appropriations measures (Military Construction-Veterans Affairs (VA), Defense, Homeland Security, State-Foreign Operations, Energy-Water, Legislative Branch, Interior-Environment), while the Senate passed the chamber’s first minibus package containing appropriations for Agriculture-Food and Drug Administration, Military Construction-VA, and Transportation-Housing and Urban Development in a bipartisan 82-15 vote last week. The two chambers’ approaches to FY 2024 government funding vary significantly, however, with the House bills containing steeper spending cuts and contentious policy riders.

 

During his first meeting with Senate Republicans since being elected House Speaker, Mike Johnson (R-La.) argued in support of another continuing resolution (CR) extending government funding through January 15. House Majority Leader Steve Scalise (R-La.) has said that any stop-gap spending bill will contain both spending cuts and policy changes. Congress faces an effective April 30 deadline to pass FY 2024 appropriations, given that the most recent debt ceiling agreement included a provision to subject all discretionary spending to a 1% cut should a CR still be in place past that date.

 

The House also passed a $14.3 billion Israel aid package in a 226-196 vote last week. Most Democrats opposed the measure, which includes cuts to the Internal Revenue Service, and the White House has already threatened to veto the bill. Senate Majority Leader Chuck Schumer (D-N.Y.) has pledged that the Senate will consider a broader package including emergency spending for Israel, Gaza, and Ukraine. Speaker Johnson stated that the House will vote on aid to Ukraine as soon as this week as a part of a package that also contains border enforcement measures. Sens. Bernie Sanders (I-Vt.), Mazie Hirono (D-Hawaii), Ed Markey (D-Mass.), Jeff Merkley (D-Ore.), Elizabeth Warren (D-Mass.), and Peter Welch (D-Vt.) sent a letter to Senate leadership last week calling for any emergency supplemental appropriations bill for Ukraine, Israel, and Gaza to contain equal funding for “major crises” domestically, including the state of the U.S. primary health care system and the opioid crisis. The White House has requested $106 billion in emergency aid for Ukraine, Israel, and Gaza.

 

Republican appropriators in the House of Representatives released a revised version of their FY 2024 Labor-Health and Human Services-Education legislation last week. Similar to other spending bills being advanced by the House, the revised HHS appropriations measure includes a number of contentious policy riders, including a provision to prevent any funding from going toward postgraduate physician training programs that mandate abortion training or penalize students who opt out of such training. The bill also includes language to block the declaration of a public health emergency related to gun violence, along with a measure to prevent funding to implement President Joe Biden’s executive order on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation. Speaker Johnson plans to bypass a full committee markup and instead bring the bill to the floor for a vote the week of November 13.

 

Senate Finance to Mark Up Mental Health, PBMs, Medicare Physician Fee Schedule Relief Extension Package This Week

Senate Finance Committee leadership released a bipartisan discussion draft of legislation containing measures related to the pharmacy benefit manager (PBM) industry as well as provisions aimed at increasing access to mental health care. The package would expand eligibility for workforce shortage incentive programs for mental health and substance use disorder clinicians, support the use of licensed clinical social workers in the Medicare program, and require Medicare Advantage plans to have up-to-date and accurate provider directories. Additionally, the draft would add to the Modernizing and Ensuring PBM Accountability Act advanced by the panel in July by mandating that prescription drug plan sponsors with preferred pharmacy networks have a minimum share of in-network pharmacies in underserved areas not tied to a PBM or the sponsor. The bill also directs the U.S. Department of Health and Human Services to collect data on drug acquisition costs, and would require plans to include certain discount-eligible drugs in their formularies. The package also mitigates the impending Medicare physician fee schedule cut by extending the relief from last year at the 2.5% level, rather than letting it drop to 1.25%. The panel plans to markup the package on Wednesday.

 

Senate to Hold NIH Director Confirmation Vote

The Senate plans to vote early this week on the nomination of Monica Bertagnolli to serve as the next director of the National Institutes of Health. A vote to end debate on the Senate floor is scheduled for Monday, which could set the stage for a final confirmation vote on Tuesday. The Senate Committee on Health, Education, Labor and Pensions advanced her nomination in a bipartisan vote late last month.

 

Pallone, Neal Push for MA Broker Compensation Oversight

House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.) and Ways and Means Committee Ranking Member Richard Neal (D-Mass.) are urging the Centers for Medicare and Medicaid Services (CMS) to increase oversight of broker participation and compensation in the Medicare Advantage (MA) market. The lawmakers raise concerns that misaligned incentives have led to broker and marketing practices that may push seniors away from the insurance plans best suited to their needs. They request that CMS move to require MA plans to report total broker compensation amounts, inclusive of any bonus or incentive payments. They also ask the agency to change the total amount brokers can receive in compensation per enrollee.

 

Additional GOP Leaders Question Proposed Changes to Nursing Home Standards

Republican leadership of the House Energy and Commerce Committee, House Ways and Means Committee, and Senate Finance Committee have sent a letter to the U.S. Department of Health and Human Services arguing that the administration’s proposed nursing home staffing requirements will jeopardize access to care, particularly for Americans in rural and underserved areas. The new rule from CMS would increase the on-site registered nurse staffing requirement to 24 hours and mandate that nursing homes provide 2.45 hours of care per resident day from nurse aides and 0.55 hours per resident day from registered nurses. The lawmakers ask that the agency withdraw the rule and work on tailored solutions “addressing the severe health care workforce shortages” across the nation.

 

Warner, Cassidy Launch Health Care Cybersecurity Working Group

Senate Intelligence Committee Chairman Mark Warner (D-Va.) and Health, Education, Labor and Pensions Ranking Member Bill Cassidy (R-La.) announced the creation of a health care cybersecurity working group last week. The lawmakers, joined by Sens. John Cornyn (R-Texas) and Maggie Hassan (D-N.H.), plan to examine proposals to address the cybersecurity of the nation’s health care system. Sen. Warner released a report last year entitled Cybersecurity is Patient Safety which considered the establishment of minimum cyber hygiene practices for health care organizations.

 

COVID Panel Probes Global Biosafety Standards, Pandemic Origins

Reps. Brad Wenstrup (R-Ohio) and Raul Ruiz (D-Calif.) have sent a letter to the Government Accountability Office requesting a report on G-20 member nations’ biosafety and biosecurity standards. The Select Subcommittee on the Coronavirus Pandemic leadership ask for a comprehensive assessment of how the current biosafety and biosecurity standards of the foreign nations compare to those existing in the United States. “As we saw during the COVID-19 pandemic, biosafety and biosecurity issues have the potential to affect the international community,” the letter states. “While the United States evaluates its own biosafety and biosecurity standards, precautions taken by other nations remain highly relevant to the Select Subcommittee’s work.”

 

Chair Wenstrup, along with House Oversight and Accountability Chairman James Comer (R-Ky.) and Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.), also informed the U.S. Department of Health and Human Services of their decision to subpoena Assistant Secretary for Legislation Melanie Egorin last week. The committee leaders argue that she has spent months evading lawmakers’ questions related to the origins of COVID-19. Egorin must now testify at a deposition on November 16.

 

President Issues AI Executive Order

President Joe Biden issued an executive order on artificial intelligence last week. The move charges the National Institute of Standards and Technology with the creation of standards to ensure that AI tools are safe and effective, and will require AI developers to share safety test results and other information with the federal government. Additionally, the order directs the U.S. Department of Health and Human Services to establish a safety program to address harms or unsafe health care practices involving AI. Measures laid out by the order are set to be implemented over the next year.

 

Bipartisan Veterans Task Force Recommends Improvements for Women’s Care

Abipartisan congressional Women Veteran Task Force submitted a report to the House Committee on Veterans’ Affairs last week making recommendations on issues that uniquely affect women veterans. The Task Force recommends more gender specific training for practitioners administering VA disability exams. The report also highlights the potential need to develop national or regional gender-specific cancer support programs, and suggests that the VA consider updating their guidelines for screening women who have heterogeneous dense breasts.

 

Upcoming Congressional Hearings and Markups

Senate Finance Committee markup of discussion draft of mental health/PBM package; time TBA; November 8

 

Senate Appropriations Committee hearing “A Review of the President’s Supplemental Request for the Departments of Health and Human Services and Homeland Security;” 9:00 a.m.; November 8

 

Senate Homeland Security and Governmental Affairs Committee hearing “The Philosophy of AI: Learning from History and Shaping Our Future;” 9:30 a.m.; November 8

 

Senate Judiciary Subcommittee on Intellectual Property hearing “Reforming the Patent Trial and Appeal Board – The PREVAIL Act and Proposals to Promote U.S. Innovation Leadership;” 2:30 p.m.; November 8

 

Senate Health, Education, Labor, and Pensions Subcommittee on Primary Health and Retirement Security hearing “Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care;” 2:30 p.m.; November 8

 

House Veterans’ Affairs Subcommittee on Health hearing “Emerging Therapies: Breakthroughs in the Battle Against Suicide?” 2:00 p.m.; November 14

 

House Veterans’ Affairs Subcommittee on Technology Modernization hearing “Electronic Health Record Modernization Deep Dive: System Uptime;” 12:00 p.m.; November 15

 

Recently Introduced Health Legislation

S.3162 – A bill to improve the requirement for the Director of the National Institute of Standards and Technology to establish testbeds to support the development and testing of trustworthy artificial intelligence systems and to improve interagency coordination in development of such testbeds, and for other purposes; Sponsor: Lujan, Ben Ray [Sen.-D-NM]; Committees: Senate – Commerce, Science, and Transportation

 

S.3165 – A bill to help persons in the United States experiencing homelessness and significant behavioral health issues, including substance use disorder, by authorizing a grant program within the Department of Health and Human Services 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: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3167 – A bill to amend the Employee Retirement Income Security Act of 1974 to clarify the treatment of certain association health plans as employers, and for other purposes; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.6122 – To require the Secretary of Health and Human Services and the Secretary of Labor to conduct a study and issue a report on grant programs to support the nursing workforce; Sponsor: Nunn, Zachary [Rep.-R-IA-3]; Committees: House – Energy and Commerce; Education and the Workforce

 

S.3171 – A bill to amend the Public Health Service Act to promote healthy eating and physical activity among children; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3172 – A bill to amend the Internal Revenue Code of 1986 to include certain over-the-counter dietary supplement products and foods for special dietary uses as qualified medical expenses; Sponsor: Cramer, Kevin [Sen.-R-ND]; Committees: Senate – Finance

 

S.3175 – A bill to establish a grant program to support schools of medicine and schools of osteopathic medicine in underserved areas; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3193 – A bill to amend the Controlled Substances Act to allow for the use of telehealth in substance use disorder treatment, and for other purposes; Sponsor: Whitehouse, Sheldon [Sen.-D-RI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3196 – A bill to amend title XIX of the Social Security Act to provide a State option to extend Medicaid coverage for foster care children while receiving treatment from a qualified residential treatment program; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Finance

 

H.R.6144 – To amend the Omnibus Crime Control and Safe Streets Act of 1968 to authorize grant programs to combat fentanyl poisonings; Sponsor: Garcia, Mike [Rep.-R-CA-27]; Committees: House – Judiciary

 

H.R.6160 – To amend the Public Health Service Act to reauthorize a lifespan respite care program; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Energy and Commerce

 

H.R.6161 – To amend the Internal Revenue Code of 1986 to allow amounts paid for over-the-counter naloxone to be taken into account in determining the deduction for medical expenses; Sponsor: Molinaro, Marcus J. [Rep.-R-NY-19]; Committees: House – Ways and Means

 

H.R.6168 – To amend the Violent Crime Control and Law Enforcement Act of 1994 to ensure that healthcare providers can assist survivors of domestic violence, and for other purposes; Sponsor: Sykes, Emilia Strong [Rep.-D-OH-13]; Committees: House – Judiciary

 

S.3200 – A bill to reauthorize the loan repayment program for the substance use disorder treatment workforce; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Finance

 

S.3202 – A bill to amend the Internal Revenue Code of 1986 to provide an alternative manner of furnishing certain health insurance coverage statements to individuals; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

S.3204 – A bill to amend Internal Revenue Code of 1986 to streamline and improve the employer reporting process relating to health insurance coverage and to protect dependent privacy; Sponsor: Warner, Mark R. [Sen.-D-VA]; Committees: Senate – Finance

 

S.3206 – A bill to provide for a study on the accessibility of substance use disorder treatment and mental health care providers and services for farmers and ranchers, and for other purposes; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3211 – A bill to enhance our Nation’s nurse and physician workforce by recapturing unused immigrant visas; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Judiciary

 

S.3215 – A bill to conduct or support further comprehensive research for the creation of a universal influenza vaccine or preventative; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3219 – A bill to protect against seasonal and pandemic influenza, and for other purposes; Sponsor: Baldwin, Tammy [Sen.-D-WI]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3220 – A bill to expand the tropical disease product priority review voucher program to encourage prevention and treatment of coccidioidomycosis; Sponsor: Kelly, Mark [Sen.-D-AZ]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3224 – A bill to codify Internal Revenue Service guidance relating to treatment of certain services and items for chronic conditions as meeting the preventive care deductible safe harbor for purposes of high deductible health plans in connection with health savings accounts; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

H.R.6171 – To amend the Internal Revenue Code of 1986 to provide a refundable credit to individuals who donate certain life-saving organs; Sponsor: Wilson, Joe [Rep.-R-SC-2]; Committees: House – Ways and Means; Energy and Commerce

 

H.R.6176 – To prohibit Federal funding of Planned Parenthood Federation of America; Sponsor: Aderholt, Robert B. [Rep.-R-AL-4]; Committees: House – Energy and Commerce

 

H.R.6177 – To prohibit Federal funding for researchers who have conducted a study or experiment relating to gender identity, and for other purposes; Sponsor: Brecheen, Josh [Rep.-R-OK-2]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means; Natural Resources

 

H.R.6184 – To conduct or support further comprehensive research for the creation of a universal influenza vaccine or preventative; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House – Energy and Commerce

 

H.R.6204 – To provide for a grant program to support access to free eye care services for students attending public elementary schools and secondary schools; Sponsor: Schiff, Adam B. [Rep.-D-CA-30]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.R.6205 – To enhance our Nation’s nurse and physician workforce by recapturing unused immigrant visas; Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]; Committees: House – Judiciary

House GOP Elects Mike Johnson (La.) as Speaker

Republicans in the House of Representatives elected Rep. Mike Johnson (R-La.) to serve as the next Speaker of the House on Wednesday, ending a three-week impasse that stalled all legislative work in the chamber. Johnson was first elected to the House in 2016, having previously worked as a senior counsel for the Alliance Defending Freedom and as a former state legislator. The Alliance Defending Freedom was involved in the recent legal case that overturned Roe v. Wade, and is now leading the push to restrict access to abortion medication. Johnson himself has sponsored a bill that would ban all abortions past 15 weeks, and has signed on as a cosponsor of legislation to codify the Hyde amendment which prohibits the use of federal funds to pay for abortion, except to save the life of the mother, or if the pregnancy is the result of incest or rape. Johnson previously served as chair of the conservative Republican Study Committee. During this time, he backed a budget proposal to raise the Medicare eligibility age to 67 and to endorse site neutral payments in the Medicare program. In 2019, he led an effort to replace Obamacare with high-risk pools, to roll back Medicaid expansion in favor of per-capita caps on the program, and to expand the use of health savings accounts. Johnson is a longstanding opponent of gender affirming care for children, and has been critical of the Centers for Disease Control and Prevention’s handing of the COVID-19 pandemic. Johnson was one of former President Donald Trump’s top allies on the Hill during his efforts to overturn Joe Biden’s 2020 presidential election victory.

 

The new Speaker is a strong advocate of cutting government spending. While he voted against the most recent continuing resolution (CR), Johnson has indicated that he is open to the next stopgap spending bill extending government funding for as long as five months. Johnson plans to pursue votes on eight spending bills ahead of the November 17 deadline to fund the federal government. If a CR is needed, Johnson has stated his intent to propose one that expires on January 15 or April 15 “to ensure the Senate cannot jam the House with a Christmas omnibus.”

 

Congress faces an effective April 30 deadline to pass fiscal year (FY) 2024 funding, given that the most recent debt ceiling agreement included a provision to subject all discretionary spending to a 1% cut should a CR still be in place past that date. The House successfully passed its Energy-Water spending bill (H.R. 4394) by a 210-199 vote last week. The House is expected to vote on Legislative Branch, Interior-Environment, and Transportation-Housing and Urban Development (HUD) appropriations the week of October 30; Financial Services and Commerce-Justice-Science the week of November 6; and Labor-Health and Human Services (HHS)-Education and Agriculture-Food and Drug Administration (FDA) the week of November 13. This plan would involve skipping committee markup of the Commerce-Justice-Science and Labor-HHS-Education bills and bringing them straight to the floor. Johnson’s plans also involve the establishment of a working group to negotiate the Agriculture-FDA bill, which was pulled from floor consideration earlier this year due to Republican in-fighting over total spending levels and a restriction that would prevent the abortion medication mifepristone from being dispensed via the mail.

 

Senate appropriators have marked up all 12 of their annual spending bills with bipartisan support, and aim to pass their first three-bill minibus comprised of Agriculture-FDA, Military Construction-Veterans Affairs, and Transportation-HUD measures (H.R. 4366) in the coming days.

 

HELP Advances NIH Nominee

The Senate Health, Education, Labor and Pensions (HELP) Committee voted to advance the nomination of Dr. Monica Bertagnolli to serve as the Director of the National Institutes of Health (NIH) in a bipartisan 15-6 vote last week. Chairman Bernie Sanders (I-Vt.) voted against the nomination, stating that he was not convinced she is prepared “to take on the greed and power of the drug companies and health care industry.” Earlier in the week, Sanders sent a letter to Christi Grimm, U.S. Department of Health and Human Services Inspector General, asking her office to investigate an exclusive patent license granted by the NIH to for a cervical cancer treatment. “I am growing increasingly alarmed that not only has the NIH abdicated its authority to ensure that the new drugs it helps develop are reasonably priced, it may actually be exceeding its authority to grant monopoly licenses to pharmaceutical companies that charge the American people, by far, the highest prices in the world for prescription drugs,” Sanders states. He suggests that the NIH should instead offer nonexclusive licenses so that more companies can manufacture the treatment at a lower cost to patients.

 

Budget Panel Task Force Considers Changes to CBO’s Scoring Methods

The House Budget Committee Health Care Task Force held its inaugural member roundtable last week to discuss the Congressional Budget Office’s (CBO) methods for analyzing policies that impact drug development in the U.S. Participants discussed how the agency developed its estimates of the Inflation Reduction Act’s impact on patient access to cures. The Task Force aims to ensure that CBO’s future analyses capture additional factors and subsequent real-world effects of policies impacting medical innovation across the nation.

 

House Members Urge Administration to Reconsider Nursing Home Staffing Rule

Agroup of 100 bipartisan members of the House of Representatives are urging the Biden administration to reconsider its proposed nursing home staffing requirements. The new rule from the Centers for Medicare and Medicaid Services would increase the on-site registered nurse staffing requirement to 24 hours and mandate that nursing homes provide 2.45 hours of care per resident day from nurse aides and 0.55 hours per resident day from registered nurses. The lawmakers, led by Rep. Greg Pence (R-Ind.), assert that the regulation would result in “limited access to care for seniors, mandatory increases in state Medicaid budgets, and could most consequentially lead to widespread nursing home closures.”

 

Lawmakers Push for Marijuana Descheduling

Abipartisan group of lawmakers have sent a letter urging the Drug Enforcement Administration (DEA) to pursue a full descheduling of marijuana. The policymakers highlight the federal-state policy gap on cannabis faced by medical practices and other stakeholders. “While Congress works to send the President comprehensive cannabis legislation, the urgency of full descheduling should inform DEA’s position on overall cannabis reform and appropriate enforcement centered on advancing public safety, not unjust criminalization,” the letter states. “Marijuana’s continued inappropriate scheduling is both arcane and out-of-touch with the will of the American people.”

 

Comer Probes FTC Move to Block Illumina’s Acquisition of Grail

House Oversight Committee Chairman James Comer (R-Ky.) has sent a letter to the Federal Trade Commission (FTC) regarding the agency’s handling of Illumina Inc.’s attempted acquisition of Grail, a cancer test provider. The European Union ordered Illumina to unwind its acquisition of Grail earlier this month, following a similar move by the FTC to block the deal earlier this year. Comer argues that the “collusion” between the FTC and EU deserves further scrutiny, and requests records of communication between the U.S regulatory agency and its European counterparts. “The FTC’s actions set a bad precedent that emboldens foreign governments to attack American businesses,” the letter states. “By deferring to foreign entities’ approaches to certain transactions, the FTC is improperly denying U.S. businesses the due process rights they are entitled to before the FTC and American courts.”

 

AAP Releases New Medicaid/CHIP Policy Statement

The American Academy of Pediatrics (AAP) released a proposal last week to overhaul how Medicaid and the Children’s Health Insurance Program (CHIP) provide health care for the nation’s children. The recommendations are aimed at providing more consistent and equitable health insurance coverage under the programs across all 50 states. The proposal would combine Medicaid and CHIP into a single program, automatically enrolling all newborns and extending program eligibility to include individuals up to the age of 26, regardless of immigration status. It would also increase the income threshold for eligibility to 400% of the federal poverty level. AAP also suggests “an end to undervalued Medicaid payment, with rates at least comparable to prevailing Medicare rates and that support the full range of services needed to provide comprehensive care to children.”

 

Recently Introduced Health Legislation

H.Res.806 – Expressing support for the recognition of October 2023, as “World Menopause Awareness Month” and expressing the sense of the House of Representatives regarding global awareness and access to care during the menopausal transition and post-menopause; Sponsor: Blunt Rochester, Lisa [Rep.-D-DE-At Large]

 

H.Con.Res.74 – Expressing support for the Geneva Consensus Declaration on Promoting Women’s Health and Strengthening the Family and urging that the United States rejoin this historic declaration; Sponsor: Banks, Jim [Rep.-R- IN-3]

 

H.R.6020 – To amend the Public Health Service Act to eliminate consideration of the income of organ recipients in providing reimbursement of expenses to donating individuals, and for other purposes; Sponsor: Obernolte, Jay [Rep.-R- CA-23]

 

H.R.6023 – To amend title 38, United States Code, to provide for the retroactive payment of benefits for veterans with covered mental health conditions based on military sexual trauma, and for other purposes; Sponsor: Carbajal, Salud O. [Rep.-D-CA-24]

 

H.R.6028 – To amend the Controlled Substances Act regarding marihuana, and for other purposes; Sponsor: Mace, Nancy [Rep.-R-SC-1]

 

H.R.6029 – To provide Medicaid assistance to individuals and families affected by a disaster or emergency, and for other purposes; Sponsor: Panetta, Jimmy [Rep.-D-CA-19]

 

H.R.6030 – To amend title XVIII of the Social Security Act to provide an option for first responders age 50 to 64 who are separated from service due to retirement or disability to buy into Medicare; Sponsor: Phillips, Dean [Rep.-D-MN-3]

 

H.R.6033 – To require the Secretary of Health and Human Services to establish a task force to improve access to health care information technology for non-English speakers; Sponsor: Steel, Michelle [Rep.-R-CA-45]

 

H.R.6038 – To amend the Public Health Service Act to provide for a Reducing Youth Use of E-Cigarettes Initiative; Sponsor: Wasserman Schultz, Debbie [Rep.-D-FL-25]

 

S.3130 – A bill to amend the Indian Health Care Improvement Act to improve the recruitment and retention of employees in the Indian Health Service, restore accountability in the Indian Health Service, improve health services, and for other purposes; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Indian Affairs

 

S.3131 – A bill to amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program; Sponsor: Barrasso, John [Sen.-R-WY]; Committees: Senate – Finance

 

H.Res.813 – Supporting the designation of October 23, 2023, as “AADC Deficiency Awareness Day”; Sponsor: Murphy, Gregory [Rep.-R-NC-3]; Committees: House – Energy and Commerce

 

H.R.6040 – To prohibit the use of Federal funds for gender transition in minors; Sponsor: Boebert, Lauren [Rep.-R- CO-3]; Committees: House – Education and the Workforce

 

H.R.6045 – To direct the Comptroller General of the United States to conduct a study and submit a report on the efficacy of Federal drug surveillance systems, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House – Energy and Commerce

 

S.3136 – A bill to amend title XIX of the Social Security Act to extend the requirement for State Medicaid plans to provide coverage for medication-assisted treatment; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Finance

 

S.3137 – A bill to allow Americans to receive paid leave time to process and address their own health needs and the health needs of their partners during the period following a pregnancy loss, an unsuccessful round of intrauterine insemination or of an assisted reproductive technology procedure, a failed adoption arrangement, a failed surrogacy arrangement, or a diagnosis or event that impacts pregnancy or fertility, to support related research and education, and for other purposes; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3138 – A bill to amend titles XIX and XXI of the Social Security Act to provide for 12-month continuous enrollment of individuals under the Medicaid program and Children’s Health Insurance Program; Sponsor: Brown, Sherrod [Sen.-D- OH]; Committees: Senate – Finance

 

S.3143 – A bill to establish postmarket reporting requirements for pharmaceuticals, and for other purposes; Sponsor: Rubio, Marco [Sen.-R-FL]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3144 – A bill to protect survivors from brain injury by authorizing the Secretary of Health and Human Services to collect data on the prevalence of brain injuries resulting from domestic and sexual violence; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3145 – A bill to amend the Public Health Service Act to authorize fellowships under the Minority Fellowship Program to be awarded for training for professionals in the addiction medicine field; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3157 – A bill to amend title XVIII of the Social Security Act to expand eligibility for incentives under the Medicare health professional shortage area bonus program to practitioners furnishing mental health and substance use disorder services; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

 

S.3158 – A bill to require the Secretary of Health and Human Services to issue guidance to States on strategies under Medicaid and CHIP to increase mental health and substance use disorder care provider education, training, recruitment, and retention; Sponsor: Stabenow, Debbie [Sen.-D-MI]; Committees: Senate – Finance

 

H.Res.815 – Expressing support for the recognition of October 26, 2023, as “Intersex Awareness Day”, and supporting the goals and ideals of Intersex Awareness Day; Sponsor: Balint, Becca [Rep.-D-VT-At Large]; Committees: House – Energy and Commerce; Education and the Workforce

 

H.Res.821 – Supporting the goals and ideals of “Creutzfeldt-Jakob Disease (CJD) Awareness Day;” Sponsor: Valadao, David G. [Rep.-R-CA-22]; Committees: House – Energy and Commerce

 

H.R.6078 – To amend the Public Health Service Acts to make community colleges eligible to participate in the Nurse Education, Practice, Quality, and Retention-Pathway to Registered Nurse Program, and for other purposes; Sponsor: Ciscomani, Juan [Rep.-R-AZ-6]; Committees: House – Energy and Commerce. A press release can be found here.

 

H.R.6088 – To require the National Academy of Sciences to establish a grant program to develop safe AI models and safe AI research, and for other purposes; Sponsor: Kiley, Kevin [Rep.-R-CA-3]; Committees: House – Science, Space, and Technology. A press release can be found here.

 

H.R.6094 – To amend titles XVIII and XIX of the Social Security Act and title XXVII of the Public Health Service Act to refine the set of information sources for determining coverage of certain drugs and biologicals used in the treatment or management of a rare disease or condition, and for other purposes; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce; Ways and Means

 

H.R.6103 – To allow Americans to receive paid leave time to process and address their own health needs and the health needs of their partners during the period following a pregnancy loss, an unsuccessful round of intrauterine insemination or of an assisted reproductive technology procedure, a failed adoption arrangement, a failed surrogacy arrangement, or a diagnosis or event that impacts pregnancy or fertility, to support related research and education, and for other purposes; Sponsor: Pressley, Ayanna [Rep.-D-MA-7]; Committees: House – Education and the Workforce; House Administration; Oversight and Accountability; Judiciary

 

H.R.6109 – To amend the Internal Revenue Code of 1986 to establish the generic drugs and biosimilars production credit, and for other purposes; Sponsor: Tenney, Claudia [Rep.-R-NY-24]; Committees: House – Ways and Means

 

H.R.6110 – To amend title XVIII of the Social Security Act to restore physician judgment to prescribe the appropriate mix of skilled modalities that constitute an intensive rehabilitation therapy program in an inpatient rehabilitation hospital or unit; Sponsor: Thompson, Glenn [Rep.-R-PA-15]; Committees: House – Ways and Means

 

H.R.6112 – To establish postmarket reporting requirements for pharmaceuticals, and for other purposes; Sponsor: Waltz, Michael [Rep.-R-FL-6]; Committees: House – Energy and Commerce; Ways and Means

What’s Next in the House Speaker Race

The House of Representatives remains without a Speaker following a closed- door Republican conference vote on Friday to drop Rep. Jim Jordan (R-Ohio) as the party’s nominee. Jordan was unable to secure the support necessary to be elected over the course of three failed floor votes last week. The House GOP is expected to meet on Monday to hear from the new candidates seeking the position, and to vote as early as Tuesday on its next speaker- designate. The members currently running for the position include House Majority Whip Tom Emmer (R-Minn.), Republican Study Committee chairman Rep. Kevin Hern (R-Okla.), House Republican Vice Conference chairman Rep. Mike Johnson (R-La.), Rep. Pete Sessions (R-Texas), Rep. Austin Scott (R-Ga.), Rep. Byron Donalds (R-Fla.), Rep. Jack Bergman (R-Mich.), Rep. Dan Meuser (R-Pa.), and Rep. Gary Palmer (R-Ala.). The chamber has a significant agenda of items to tackle whenever a speaker is elected. The current continuing resolution (CR) funding the federal government expires November 17. Federal funding for community health centers and health workforce programs were also temporarily extended by the CR. Both the Pandemic All Hazards Preparedness Act (PAHPA) and the President’s Emergency Plan for AIDS Relief (PEPFAR) program authorizations expired on September 30, with only certain PAHPA authorities temporarily extended by the CR.

 

HELP to Vote on NIH Nominee This Week

President Joe Biden’s nominee to serve as Director of the National Institutes of Health (NIH) Dr. Monica Bertagnolli declined to specify what steps she would take to lower drug prices during her confirmation hearing before the Senate Health, Education, Labor, and Pensions (HELP) Committee last week. Chairman Bernie Sanders (I-Vt.) asked the nominee whether she would commit to reinstating and expanding the reasonable pricing clause in NIH contracts. While Bertagnolli agreed that taxpayers deserve a fair return on their investment, she did not explicitly commit to whether she would, or would not, use the reasonable pricing clause if confirmed. The HELP Committee is scheduled to vote on Bertagnolli’s nomination on Wednesday.

 

Senators Launch Mental Health Caucus

Sens. Alex Padilla (D-Calif.), Thom Tillis (R-N.C.), Tina Smith (D-Minn.), and Joni Ernst (R-Iowa) announced the launch of a new bipartisan Mental Health Caucus last week. The 10-member caucus will focus on addressing health care workforce issues, raising awareness of the 988-crisis hotline, and effectively implementing the Bipartisan Safer Communities Act. The other members of the caucus include Sens. Cory Booker (D-N.J.), Shelley Moore Capito (R-W.Va.), Susan Collins (R-Maine), John Fetterman (D-Pa.), Amy Klobuchar (D-Minn.), and Lisa Murkowski (R-Alaska).

 

Lawmakers Comment on Biden Administration’s Proposed Changes to Mental Health Parity Requirements

Leadership of the House Education and Workforce Committee have weighed in on the Biden administration’s proposed expansion of mental health parity requirements. The regulation builds on the Mental Health Parity and Addiction Equity Act by mandating that insurers analyze the outcomes of their coverage policies. In her comments submitted on the proposed rule, Chair Virginia Foxx (R-N.C.) argued that the regulation “will serve only to weaken parity compliance by given prominence to bureaucratic reporting, paperwork, and audits.” Ranking Member Bobby Scott (D-Va.) and Health Subcommittee Ranking Member Mark DeSaulnier (D-Calif.), however, expressed support for the proposed rule and urged the administration to further limit the exceptions to the non-quantitative treatment limitation requirements contemplated by the proposal.

 

CA Sen. Butler Will Not Seek a Full Term

Sen. Laphonza Butler (D-Calif.) has confirmed that she will not run for a full Senate term in 2024. Butler, a labor leader and consultant, was recently appointed to fill the seat of the late Dianne Feinstein. Senate Majority Leader Chuck Schumer (D-N.Y.) confirmed last week that Sen. Butler will take the late Feinstein’s seat on the Judiciary Committee. Sen. Kyrsten Sinema (I-Ariz.) will take her place on the Appropriations Committee and Sen. Mark Kelly (D-Ariz.) will fill her seat on the Intelligence panel.

 

CMS Rejects More than 300 Misleading MA Ads

The Centers for Medicare and Medicaid Services (CMS) rejected more than 300 misleading advertisements for Medicare Advantage (MA) plans in the lead-up to this year’s open enrollment period. For the first time, and in response to complaints about MA ads, the agency reviewed more than 1,700 ads between May and September. Of the more than 250 ads submitted by third-party marketing organizations, 192 were rejected. Plans were permitted to start advertising on October 1st ahead of open enrollment, which runs from October 15 through December 7. The Senate Finance Committee convened a hearing on the subject of deceptive MA marketing practices on Wednesday and heard testimony from the Ohio Department of Insurance, Security Health Plan, and Chapter, a technology-enabled Medicare and retirement navigation platform.

 

Upcoming Congressional Hearings and Markups

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic “Reforming the WHO: Ensuring Global Health Security and Accountability;” 10:00 a.m.; October 24

 

Senate Health, Education, Labor, and Pensions Committee executive session to consider the nomination of Monica Bertagnolli to be Director of the National Institutes of Health; 10:00 a.m.; October 25

 

House Energy and Commerce Subcommittee on Health hearing “Supporting Access to Long-Term Services and Supports: An Examination of the Impacts of Proposed Regulations on Workforce and Access to Care;” 2:00 p.m.; October 25

 

Senate Veterans’ Affairs Committee hearing “VA Accountability and Transparency: A Cornerstone of Quality Care and Benefits for Veterans;” 3:30 p.m.; October 25

 

Senate Specialty Committee on Aging hearing “Unlocking Hope: Access to Therapies for People with Rare, Progressive, and Serious Diseases;” 10:00 a.m.; October 26

 

Senate Committee on Health, Education, Labor, and Pensions field hearing “Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?;” 9:00 a.m.; October 27

 

Recently Introduced Health Legislation

H.R.5958 – To amend title XI of the Social Security Act to require that direct-to-consumer advertisements for drugs and biologicals include an appropriate disclosure of pricing information. Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]

 

H.R.5957 – To amend the Public Health Service Act to establish a program of research regarding the risks posed by the presence of dioxins, phthalates, pesticides, chemical fragrances, and other components of menstrual products and intimate care products. Sponsor: Meng, Grace [Rep.-D-NY-6]

 

H.Res.784 – Supporting the designation of October 15, 2023, as “National Pregnancy and Infant Loss Remembrance Day” and recognizing the people who have lost a pregnancy or an infant. Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]

 

S.3048 – A bill to amend the Family and Medical Leave Act of 1993 to prohibit an employer from recovering any health care premium paid by the employer for an employee if the employee fails to return to work due to the birth of a child, and for other purposes; Sponsor: Vance, J. D. [Sen.-R-OH]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3059 – A bill to amend title XVIII of the Social Security Act to establish provider directory requirements, and to provide accountability for provider director accuracy, under Medicare Advantage; Sponsor: Bennet, Michael F. [Sen.-D-CO]; Committees: Senate – Finance

 

S.3060 – A bill to establish a Youth Mental Health Research Initiative in the National Institutes of Health for purposes of encouraging collaborative research to improve youth mental health; Sponsor: Klobuchar, Amy [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.Res.792 – Expressing support for the designation of October 17, 2023, as “National Vitiligo Awareness Day”; Sponsor: Johnson, Henry C. “Hank,” Jr. [Rep.-D-GA-4]

 

H.R.5975 – To authorize grants to implement school-community partnerships for preventing substance use and misuse among youth; Sponsor: Sánchez, Linda T. [Rep.-D-CA-38]

 

H.R.5976 – To establish a Youth Mental Health Research Initiative in the National Institutes of Health for purposes of encouraging collaborative research to improve youth mental health; Sponsor: Watson Coleman, Bonnie [Rep.-D-NJ-12]

 

S.3069 – A bill to amend title XVIII of the Social Security Act to provide coverage for custom fabricated breast protheses following a mastectomy; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Finance

 

S.3070 – A bill to amend the SUPPORT for Patients and Communities Act to reauthorize the youth prevention and recovery initiative; Sponsor: Peters, Gary C. [Sen.-D-MI]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.5984 – To authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants for expanding, modernizing, or streamlining emergency room operations; Sponsor: Lawler, Michael [Rep.-R-NY-17]

 

S.3085 – A bill to establish a program for purposes of carrying out programs to prevent adverse childhood experiences and promoting positive childhood experiences, and to require the Secretary of Health and Human Services to conduct studies, evaluations, and research to address adverse childhood experiences, including through the promotion of positive childhood experiences; Sponsor: King, Angus S., Jr. [Sen.-I-ME]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.3090 – A bill to amend titles XIX and XXI of the Social Security Act to improve Medicaid and the Children’s Health Insurance Program for low-income mothers; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate – Finance

 

S.3091 – A bill to amend title XVIII of the Social Security Act to permit certain clinics to qualify as a rural emergency hospital under the Medicare program; Sponsor: Murkowski, Lisa [Sen.-R-AK]; Committees: Senate – Finance

 

S.3098 – A bill to amend title XIX of the Social Security Act to make permanent the Medicaid option to remove the IMD exclusion to provide medical assistance for certain individuals who are patients in an institution for mental diseases; Sponsor: Thune, John [Sen.-R-SD]; Committees: Senate – Finance

 

S.3103 – A bill to amend the Fair Credit Reporting Act to prohibit the inclusion of medical debt on a consumer report, and for other purposes; Sponsor: Merkley, Jeff [Sen.-D-OR]; Committees: Senate – Banking, Housing, and Urban Affairs

 

H.R.6003 – To amend the Fair Credit Reporting Act to prohibit the inclusion of medical debt on a consumer report, and for other purposes; Sponsor: Porter, Katie [Rep.-D-CA-47]

 

H.R.6004 – To amend titles XIX and XXI of the Social Security Act to improve Medicaid and the Children’s Health Insurance Program for low-income mothers; Sponsor: Pressley, Ayanna [Rep.-D-MA-7]

GOP Nominee Jordan Faces Unclear Path to Speaker

The House of Representatives remains without a speaker following the ousting of Kevin McCarthy (R-Calif.) on October 3. On Friday, Rep. Jim Jordan (R-Ohio) became the House GOP’s new nominee for speaker following a closed- door 124-81 vote. Speaker designate Steve Scalise (R-La.) dropped out of the race on Thursday after it became clear that he did not have enough support amongst Republican lawmakers to be elected on the floor. Scalise had previously beat out Jordan to earn the GOP conference nomination in a 113-99 vote earlier in the week. Any nominee will need to receive 217 votes to win the speakership on the floor. House Minority Leader Hakeem Jeffries (D-N.Y.) stated over the weekend that “informal conversations” are taking place regarding a bipartisan solution to the chamber’s current speaker situation. Over the weekend, House Republican Leadership announced plans to vote on the election of the Speaker on Tuesday afternoon.

 

A group of centrist House Democrats have sent a letter to House Speaker Pro Tempore Patrick McHenry (R-N.C.) stating that they would back the temporary expansion of McHenry’s authority to allow the chamber to take up urgent legislative matters, including government funding and foreign aid. The current continuing resolution expires on November 17, and the House is unable to vote on a government funding plan until a new speaker is elected. “In light of our nation’s pressing issues, a looming government shutdown, and the attacks on our key ally, Israel, we strongly support an immediate vote to expand the Speaker Pro Tempore’s authorities to all for the consideration of a legislative agenda limited to the most pressing issues,” the lawmakers said. They suggest the expansion of the speaker pro tempore’s authorities in 15-day increments until the election of a new speaker. The letter was signed by four leaders of the bipartisan Problems Solvers Caucus: Reps. Josh Gottheimer (D-N.J.), Ed Case (D-Hawaii), Susie Lee (D-Nev.), and Jared Golden (D-Maine).

 

GOP Doctors Caucus Release Proposal to Reform MPFS

The GOP Doctors Caucus released a discussion draft of legislation last week that would overhaul Medicare’s physician fee schedule (MPFS). The proposal would provide more flexibility around how much the Centers for Medicare and Medicaid Services can spend. The agency is currently restrained by a budget neutrality requirement. The bill would also update how the Medicare program calculates practice expense relative value units (RVUs). Practice expense RVUs have been on the decline since they were last addressed by Congress in 2015.

 

Blackburn Urges HHS to Affirm Parameters Around Patient Cost-Sharing

Sen. Marsha Blackburn (R-Tenn.) has sent a letter urging the U.S. Department of Health and Human Services (HHS) to affirm that patients’ prescription drug payments, including when financed through copay assistance, constitute cost- sharing, and should be treated as such. Blackburn cites data finding that manufacturer-funded copay assistance reduced Americans’ prescription drug costs by nearly $19 billion last year, and that forgone or delayed care due to accumulators and other comparable tools likely total between $1.3 billion and $2.5 billion annually. “By clarifying that cost-sharing, even when financed through a copay assistance program, still comprises cost-sharing, HHS could correct the legal defects of the 2021 Notice of Benefit and Payment Parameters and save patients tens of billions in out-of-pocket costs,” Blackburn argues.

 

HELP Dems Release Staff Report on Nonprofit Charity Care

Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-Vt.) has released a majority staff report asserting that major non-profit hospitals are prioritizing profits over spending on charity care. The Affordable Care Act requires nonprofit hospitals to establish financial assistance policies to care for patients who are unable to afford treatment. According to the report, between 2012 and 2019 nonprofit hospitals increased their average operating profits by 36% and nearly doubled their cash reserves, while their average spending on charity care decreased from $6.7 million to $6.4 million over the same period. Of the 16 largest nonprofit hospitals, 12 of them dedicated less than 2% of their total revenue to charity care, and half of those dedicated less than 1%. The report recommends mandating that tax-exempt hospitals provide a minimum level of charity care and suggests reforms to increase transparency around the reporting of community benefit data to the Internal Revenue Service.

 

Doc Caucus Comments on Proposed Nursing Home Staffing Requirements

The GOP Doctors Caucus is asking the Biden administration to reconsider its proposed rule regarding nursing home staffing requirements. The new rule from the Centers for Medicare and Medicaid Services would increase the on-site registered nurse staffing requirement to 24 hours and mandate that nursing homes provide 2.45 hours of care per resident day from nurse aides and 0.55 hours per resident day from registered nurses. The lawmakers express concerns that the “one-size-fits-all approach to staffing long-term care facilities, especially those in rural areas, is tone deaf to challenges they face.”

 

Upcoming Congressional Hearings and Markups

House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic hearing “Strengthening Biosafety and Biosecurity Standards: Protecting Against Future Pandemics;” 10:00 a.m.; October 18

 

House Science, Space, and Technology Subcommittee on Investigations and Oversight hearing “Balancing Knowledge and Governance: Foundations for Effective Risk Management of Artificial Intelligence;” 10:00 a.m.; October 18

 

House Energy and Commerce Subcommittee on Innovation, Data, and Commerce hearing “Safeguarding Data and Innovation: Building the Foundation for the Use of Artificial Intelligence;” 10:00 a.m.; October 18

 

Senate Committee on Health, Education, Labor, and Pensions hearing to examine the nomination of Monica M. Bertagnolli, of Massachusetts, to be Director of the National Institutes of Health; 10:00 a.m.; October 18

 

Senate Finance Committee hearing “Medicare Advantage Annual Enrollment: Cracking Down on Deceptive Practices and Improving Senior Experiences;” 10:00 a.m.; October 18 Senate Budget Committee hearing “Improving Care, Lowering Costs: Achieving Health Care Efficiency;” 10:00 a.m.; October 18

 

House Energy and Commerce Subcommittee on Environment, Manufacturing, and Critical Materials hearing “Exposing EPA Efforts to Limit Chemicals Needed for Life-Saving Medical Devices and Other Essential Products;” 10:30 a.m.; October 18

 

House Energy and Commerce Subcommittee on Health hearing “What’s the Prognosis?: Examining Medicare Proposals to Improve Patient Access to Care & Minimize Red Tape for Doctors;” 10:00 a.m.; October 19

 

House Veterans’ Affairs Subcommittee on Health hearing “Emerging Therapies: Breakthroughs in the Battle Against Suicide?” 1:30 p.m.; October 19

 

Senate Committee on Health, Education, Labor, and Pensions field hearing “Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?;” 9:00 a.m.; October 27

 

Recently Introduced Health Legislation

H.R.5910 – To prioritize educating and training for existing and new environmental health professionals. Sponsor: Thanedar, Shri [Rep.-D-MI-13]

 

H.R.5909 – To amend title XXVII of the Public Health Service Act to limit cost sharing for prenatal services in certain circumstances. Sponsor: Spanberger, Abigail Davis [Rep.-D-VA-7]

 

H.R.5906 – To amend title XI of the Social Security Act to exclude expenditures attributable to a State medicaid fraud control unit from the payment limits under Medicaid for Guam, the Northern Mariana Islands, and American Samoa. Sponsor: Sablan, Gregorio Kilili Camacho [Del.-D-MP-At Large]

 

H.R.5901 – To amend the Public Health Service Act to encourage programs to address college athlete mental health. Sponsor: Hudson, Richard [Rep.-R-NC-9]

 

H.R.5894 – Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2024, and for other purposes. Sponsor: Aderholt, Robert B. [Rep.-R-AL-4]

 

H.Res.766 – Supporting the designation of October 7, 2023, as National Ostomy Awareness Day. Sponsor: Payne, Donald M., Jr. [Rep.-D-NJ-10]

 

H.Res.780 – Expressing support for the goals of “World Sight Day” by promoting the importance of accessible, affordable, and inclusive eye care; Sponsor: Veasey, Marc A. [Rep.-D-TX-33]

 

H.R.5924 – To amend title XVIII of the Social Sec

urity Act with respect to the timing of changes to the annual out-of- pocket threshold for the Medicare prescription drug benefit, and to amend title XI of such Act with respect to the timing of the Medicare drug price negotiation program; Sponsor: Magaziner, Seth [Rep.-D-RI-2]

 

H.Res.782 – Thanking and promoting the professions of perinatal nurses by encouraging participation in National Perinatal Nurses Week; Sponsor: Joyce, David P. [Rep.-R-OH-14]

 

H.R.5935 – To amend title XVIII of the Social Security Act to extend the Quality Payment Program-Small Practice, Underserved, and Rural Support program; Sponsor: Stansbury, Melanie Ann [Rep.-D-NM-1]

 

H.R.5938 – To amend the Veterans’ Benefits Improvements Act of 1996 and the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020 to improve the temporary licensure requirements for contract health care professionals who perform medical disability examinations for the Department of Veterans Affairs, and for other purposes; Sponsor: Ciscomani, Juan [Rep.-R-AZ-6]

 

H.R.5948 – To terminate the Office of Gun Violence Prevention in the Executive Office of the President and prohibit the establishment of any similar successor office, and for other purposes; Sponsor: Rosendale Sr., Matthew M. [Rep.-R-MT-2]

Kevin McCarthy Ousted as House Speaker

Last week, eight conservative critics of Rep. Kevin McCarthy (R-Calif.) were joined by the House Democratic caucus in successfully ousting McCarthy as Speaker of the House in a 216-210 vote. The motion to vacate was brought to the floor by Rep. Matt Gaetz (R-Fla.) and supported by Republican Reps. Andy Biggs (Ariz.), Ken Buck (Colo.), Tim Burchett (Tenn.), Eli Crane (Ariz.), Bob Good (Va.), Nancy Mace (S.C.), and Matt Rosendale (Mont.). McCarthy is the first House speaker in history to be removed from the job. The GOP dissidents cited McCarthy’s support for the latest continuing resolution to prevent a government shutdown as the main reason for their campaign against him. Rep. Patrick McHenry (R-N.C.) has been tapped to serve as speaker pro-tempore, having been on the top of McCarthy’s secret list of successors, a practice initiated after 9/11 to protect the continuity of government. While the chamber cannot vote on legislation until a new speaker has been elected, McHenry now has the full power of speaker to sign enrolled bills and joint resolutions and usher the House through votes to elect a permanent replacement.

 

House Majority Leader Steve Scalise (R-La.) and Rep. Jim Jordan (R-Ohio), who both supported Speaker McCarthy in last week’s vote, have formally announced their candidacies to be the next Speaker. Both members are seen as ideologically to the right of McCarthy, with Jordan being considered the more conservative of the two. Jordan currently serves as chair of the House Judiciary Committee and is leading the GOP’s investigations into the current administration and Biden family. He recently voted against the continuing resolution to keep the government running through November 17, while Scalise voted in favor of it. Both candidates have focused on the need to address the fentanyl crisis and have criticized the Biden administration’s response to the COVID-19 pandemic. Jordan has been endorsed by former president Donald Trump. Gaetz has expressed support for both bids for speaker while emphasizing that a plan to reduce government spending is more important than the individual speaker themself.

 

The House GOP plans to hold a party conference on Tuesday to provide rank-and-file members the opportunity to ask questions of the candidates. The conference would then vote on their nominee for speakership. If a strong candidate emerges, McHenry plans to hold a floor vote to elect a new speaker on Wednesday. The next speaker faces a possible government shutdown when the current continuing resolution expires on November 17, as well as reauthorization of key health programs like the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), the Children’s Hospital Graduate Medical Education program, the Pandemic and All-Hazards Preparedness Act, and the SUPPORT Act, which expired last month.

 

GOP Senators Pledge to Block Bills Unrelated to Government Funding

Agroup of 20 Republican senators have sent a letter to Senate Majority Leader Chuck Schumer (D-N.Y.) pledging to withhold their support for any vote to proceed to items unrelated to the fiscal year 2024 appropriations process. “We urge you to present a plan to the Republican Conference for how you intend to pass the remaining appropriations bills and conference them with the House in a manner that respects an open amendment process and which does not end in a December omnibus spending package,” the letter states. The lawmakers highlight that limited time remains until government funding once again expires on November 17th.

 

Ways and Means Members Probe Implementation of Hospice Special Focus Program

Abipartisan group of House Ways and Means Committee members have sent a letter to the Biden administration regarding the Hospice Special Focus Program (SFP). The lawmakers assert that the Centers for Medicare and Medicaid Services’ (CMS) proposal for identifying poorly performing hospices is based on incomplete survey data and would “not adequately identify hospices that are truly struggling with performance.” The letter also encourages CMS to ensure Medicare-certified hospices get a preview of their performance under the SFP before the program is formally launched. The letter was signed by Reps. Beth Van Duyne (R-Texas), Earl Blumenauer (D-Ore.), Brad Wenstrup (R-Ohio), and Jimmy Panetta (D-Calif.).

 

Warren, Jayapal Urge Scrutiny of UnitedHealth, Amedisys Merger

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) have requested that antitrust regulators examine UnitedHealth Group’s proposed acquisition of home health and hospice provider Amedisys Inc. The letter characterizes the deal as the “latest example of massive health care conglomerates using anti-competitive mergers to increase their market dominance, reducing competition, hurting patients, and increasing health care costs.” The lawmakers urge the Department of Justice to closely scrutinize the deal and to “oppose the growing trend of insurers buying up health care providers to reduce competition.”

 

Laphonza Butler Sworn in as Senator

California Governor Gavin Newsom (D) tapped Laphonza Butler, president of EMILY’s List, to fill the seat of the late Sen. Dianne Feinstein. EMILY’s List advocates for the election of Democratic, pro-choice women to political office. Butler previously served as president of SEIU Local 2015 in California, and has also worked as a partner at political consulting firm SCRB Strategies. Butler was sworn in by Vice President Kamala Harris on Tuesday, becoming only the third Black female senator in history. She is one of three LGBTQ senators currently in office. She has not yet indicated whether she will seek the office in the 2024 election.

 

CBO Issues Call for New Obesity Research

The Congressional Budget Office (CBO) is requesting new research to inform its analysis of obesity treatment policies, including the use of new anti-obesity medications. Medicare is currently prohibited from covering weight-loss drugs like Ozempic and Trulicity, but legislation – including the Treat and Reduce Obesity Act (S. 2407/H.R. 4818) – has been introduced to change that policy. CBO’s blog on the issue states that were Medicare to pay for these drugs some of the cost would be captured through higher premiums and patient cost sharing, but that the drugs’ net cost to the Medicare program would still be “significant” over the next decade.

 

DEA Extends COVID Telehealth Rules for Remote Prescribing

The Drug Enforcement Administration (DEA) has extended COVID-era flexibilities for the prescription of controlled substances via telemedicine through the end of 2024. The agency’s second temporary rule will allow all patients to be prescribed controlled substances without an in-person visit. DEA plans to issue new standards by fall 2024 that will “most effectively expand access to telemedicine encounters” while also preventing misuse.

 

Recently Introduced Health Legislation

S.Res.389 – A resolution expressing support for the annual designation of October 1st as “National Latino/a Physician Day”. Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Health, Education, Labor, and Pensions

 

H.R.5864 – To amend title XIX of the Social Security Act to provide for coverage under the Medicaid program of non- invasive prenatal genetic screening; Sponsor: Fitzpatrick, Brian K. [Rep.-R-PA-1]; Committees: House – Energy and Commerce

 

H.R.5866 – To ensure comprehensive wraparound services for families impacted by substance use disorders, and for other purposes; Sponsor: Lee, Barbara [Rep.-D-CA-12]; Committees: House – Energy and Commerce; Ways and Means; Education and the Workforce

 

S.3006 – A bill to ensure comprehensive wraparound services for families impacted by substance use disorders, and for other purposes; Sponsor: Markey, Edward J. [Sen.-D-MA]; Committees: Senate – Health, Education, Labor, and Pensions

 

S.Res.405 – A resolution expressing support for the designation of September 30, 2023, as “National Veterans Suicide Prevention 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.3010 – A bill to amend title XVIII of the Social Security Act to provide coverage of medical nutrition therapy services for individuals with eating disorders under the Medicare program; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Finance

 

S.3021 – A bill to amend title XVIII of the Social Security Act to permanently extend certain in-home cardiopulmonary rehabilitation flexibilities established in response to COVID-19, and for other purposes; Sponsor: Sinema, Kyrsten [Sen.-I- AZ]; Committees: Senate – Finance

 

S.3022 – A bill to amend the Indian Health Care Improvement Act to allow Indian Health Service scholarship and loan recipients to fulfill service obligations through half-time clinical practice, and for other purposes; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate – Indian Affairs