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

 

GOP Health Leaders Request Transparency on Medicare Drug Negotiation Implementation

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

 

Bilirakis, Tonko Launch Longevity Science Caucus

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

 

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

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

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

 

Warren Leads Letter on Keytruda Patents

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

 

Democrats Urge Administration to Address “Junk” Health Plans

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

 

Wyden, Warren Request Info on McKinsey Hospital Guidance

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

 

POLICY BRIEFINGS

 

Upcoming Congressional Hearings and Markups

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

 

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

 

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

 

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

 

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

 

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

 

Recently Introduced Health Legislation

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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

 

Senate Appropriations Announces Subcommittee Rosters

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

 

Coronavirus Panel Jumpstarts COVID-19 Origins Investigation

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

 

New GAO Report on Private Equity and IRB Effectiveness

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

 

Feinstein Announces Retirement Decision

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

 

POLICY BRIEFINGS

Fetterman Seeks Treatment for Depression

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

 

Casey Undergoes Surgery for Prostate Cancer

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

 

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

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

 

Upcoming Congressional Hearings and Markups

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

 

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

 

Recently Introduced Health Legislation

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

 

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

 

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

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Recently Introduced Health Legislation -cntd

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

S.462 – A bill to amend the Public Health Service Act to modify the loan repayment program for the substance use disorder treatment workforce to relieve workforce shortages; Sponsor: Smith, Tina [Sen.-D-MN]; Committees: Senate – Health, Education, Labor, and Pensions

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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

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

 

 

Senate Judiciary Advances Five Bipartisan Drug Pricing Bills

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

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

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

Finance, HELP Leadership Consider Common Ground for 118th Congress

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

 

HHS Prepares States, Stakeholders For End of PHE

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

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

 

BCBSA Proposes Policies to Reduce Health Care Costs

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

 

Upcoming Congressional Hearings and Markups

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

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

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

 

POLICY BRIEFINGS

Recently Introduced Health Legislation

H.R.830 – To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes; Sponsor: Carter, Earl L. “Buddy” [Rep.-R-GA-1]; Committees: House – Energy and Commerce

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

The Biden administration announced plans last week to end the COVID-19 emergency declarations on May 11. The decision applies to both the national emergency and public health emergency (PHE) in response to COVID-19 that have remained in place for over three years since they were first declared. The end of the emergency declarations will result in a restructured federal COVID-19 response that shifts much of the responsibility for vaccine and treatment distribution to the private sector. People without health insurance will be responsible for paying for vaccines, tests, and treatments out-of-pocket, while insured individuals may see the cost of such products increase. Vaccines will remain free for Medicare, Medicaid, and Children’s Health Insurance Program beneficiaries. Other flexibilities and regulatory authorities instituted in response to the COVID-19 PHE would also end, though some measures have already been de-linked from the emergency declaration. The Consolidated Appropriations Act, 2023, for example, extends certain telehealth policies through 2024 and permits states to resume Medicaid redeterminations in April. Other provisions, such as the Medicare coverage requirement waivers (like the three-day hospital stay requirement prior to a skilled nursing facility admission) and permission for patients to get extended supplies of many drugs under the Medicare prescription drug benefit, were not extended in the year-end funding bill. Hospitals will also no longer receive the 20% increased Medicare payment for the treatment of COVID-19 patients. According to a senior administration official, the transition period over the next three months will allow the White House to “begin the process of a smooth operational wind-down of the flexibilities enabled by the COVID-19 emergency declarations.” The announcement was made within a series of White House statements in opposition to several bills passed by the House of Representatives warning that ending the PHE too soon would have “highly significant impacts on our nation’s health system and government operations.” The bills passed the House include:
H.R. 497 – Freedom for Health Care Workers Act, to block the federal COVID-19 vaccine mandate for health care workers under the Medicare and Medicaid programs;
H.R. 382 – Pandemic is Over Act, to end the COVID-19 PHE;
H.R. 139 – SHOW UP Act of 2023, to end COVID-era telework policies for federal workers; and
H.J. Res. 7, to terminate the national emergency declared on March 13, 2020.
This week, the House plans to vote on legislation (H.R. 185) that would end the COVID-19 vaccine mandate for international travelers entering the U.S. Proponents of the bill argue that the requirement should be dropped given the ending of the COVID-19 emergency declarations on May 11.

 

President’s FY24 Budget to Be Released March 9

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

 

Wyden Requests Details on IRA’s Drug Rebate Provisions

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

 

Senators Criticize Lack of FDA Vaping Regulation Enforcement

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

 

Legislators Urge Elevation of ONDCP

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

 

Lawmakers Request More Funding for KidneyX

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

 

Democrats Ask Manufacturer to Revise Mifepristone Label

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

 

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

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

 

POLICY BRIEFINGS

 

Upcoming Congressional Hearings and Markups

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

Recently Introduced Health Legislation

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