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

 

Oversight Panel to Probe FTC’s Handling of Amgen Merger

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

 

AHA Urges CMS to Address MA Plan Violations

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

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

 

Congress Retirements and Resignations

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

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

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

 

Upcoming Congressional Hearings and Markups

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

 

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

 

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

 

Recently Introduced Health Legislation

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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

 

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

 

E&C Health Panel Advances 21 Bills

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

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

 

Warnock, Kennedy Report on Insulin Deserts

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

 

Bipartisan Group Investigates Health Risks of Meta Platforms

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

 

Congressional Retirements

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

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

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

 

Combined Senate/House 2024 Calendar

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

 

Senior FDA Regulator Woodcock to Retire

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

 

President Appoints New NCI Director

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

 

White House Initiative on Women’s Health Research

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

 

Speaker Johnson Hires New Health Staffer

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

 

Recently Introduced Health Legislation

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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

 

Senate Confirms Monica Bertagnolli as NIH Director

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

 

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

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

 

Finance Leadership Requests Artificial Intelligence Briefing

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

 

HELP Chair Continues Push for Reasonable Pricing and Access Standards

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

 

Warren Comments on Amgen Acquisition of Horizon Therapeutics

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

 

Congressional Retirements

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

 

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

 

Ways and Means Republicans Criticize NSA Implementation

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

 

E&C Republicans Probe SAMHSA Expenditures

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

 

House Releases 2024 Legislative Calendar

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

 

House GOP Leadership Update

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

 

President Acts to Expand Veterans’ Health Care Coverage

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

 

CMS Issues 2025 MA, Part D Proposed Rule

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

 

Upcoming Congressional Hearings and Markups

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

 

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

 

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

 

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

 

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

 

Recently Introduced Health Legislation

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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

 

FY 2024 Appropriations Update

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

 

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

 

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

 

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

 

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

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

 

Senate to Hold NIH Director Confirmation Vote

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

 

Pallone, Neal Push for MA Broker Compensation Oversight

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

 

Additional GOP Leaders Question Proposed Changes to Nursing Home Standards

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

 

Warner, Cassidy Launch Health Care Cybersecurity Working Group

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

 

COVID Panel Probes Global Biosafety Standards, Pandemic Origins

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

 

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

 

President Issues AI Executive Order

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

 

Bipartisan Veterans Task Force Recommends Improvements for Women’s Care

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

 

Upcoming Congressional Hearings and Markups

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Recently Introduced Health Legislation

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

 

S.3165 – A bill to help persons in the United States experiencing homelessness and significant behavioral health issues, including substance use disorder, by authorizing a grant program within the Department of Health and Human Services to assist State and local governments, continuums of care, community-based organizations that administer both health and homelessness services, and providers of services to people experiencing homelessness, better coordinate health care and homelessness services, and for other purposes; Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate – Health, Education, Labor, and Pensions

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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