Tag: Administration

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-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 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-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 117^th 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 6^th 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 19^th 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

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