Month: April 2024

Budget Leadership Requests GAO Review of CMMI–House Budget Committee Chairman Jodey Arrington (R-Texas) and Budget Committee Health Care Task Force Chair Michael Burgess (R-Texas) are requesting that the Government Accountability Office (GAO) investigate the effectiveness of the Center for Medicare and Medicaid Innovation (CMMI). Arrington and Burgess argue that CMMI has failed to deliver on its mandate to test new payment models that address health care costs and quality. CMMI spending is set to increase by $1.3 billion by 2030, while only six of the more than 50 models it has tested have resulted in statistically significant savings. “We must conduct budgetary oversight of mandatory health care programs such as CMMI that are adding to our national debt and not delivering for taxpayers or patients,” Arrington and Burgess stated. The lawmakers ask GAO to review the agency’s dedicated funding and performance and to evaluate which of the payment models tested by CMMI have saved money or increased spending.

Sanders Opens Investigation into Weight-Loss Drug Pricing–Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-Vt.) is opening a new investigation into the price of weight-loss drugs Ozempic and Wegovy. The products currently sell for approximately $1,000 a month. “The unjustifiably high prices of Ozempic and Wegovy are already straining the budgets of Medicare and Medicaid and severely limiting access for patients who need these drugs,” the HELP Chairman argued. Sanders sent a letter to Novo Nordisk’s CEO requesting that the drug company substantially reduce the list price and the net price of both Ozempic and Wegovy, and provide detailed information regarding the pricing, cost, and sale of each product. “The scientists at Novo Nordisk deserve great credit for developing these drugs that have the potential to be a game changer for millions of Americans struggling with type 2 diabetes and obesity. As important as these drugs are, they will not do any good for the millions of patients who cannot afford them,” Sanders wrote.

Cole Announces Appropriations Deadline and Updates to Earmarking Process–House Appropriations Committee Chairman Tom Cole (R-Okla.) announced a change to the congressional earmarking process for fiscal year (FY) 2025 last week. The new policy will restrict the House of Representatives from earmarking funds for nonprofits, including health care facilities, under the latest Transportation-Housing and Urban Development appropriations bill. House Republicans had previously banned earmarks under Defense, Financial Services, and Labor-Health and Human Services-Education appropriations ahead of FY 2024 spending bills. Cole also announced a deadline of May 3, 2024, for members to submit their earmark requests.

NJ Rep. Donald Payne Dies Following Heart Attack–Six-term Congressman Donald Payne Jr. (D-N.J.) died last week at the age of 65. Payne had been hospitalized since suffering a cardiac episode related to complications from diabetes earlier this month. Payne succeeded his father, New Jersey’s first-ever Black representative in Congress, in representing the state’s 10^th congressional district. During his time in the House of Representatives he sponsored legislation to promote screening for colorectal cancer and peripheral arterial disease. He was a member of the Homeland Security and Transportation and Infrastructure committees. House leadership announced that votes are no longer expected May 2 to accommodate his funeral service. Payne’s death leaves the House with a 217-212 Republican-Democratic split, with six vacancies.

WHO Finds Widespread Overuse of Antibiotics During COVID Pandemic–The World Health Organization (WHO) released new findings last week revealing extensive, world-wide overuse of antibiotics during the COVID-19 pandemic. While only 8% of hospitalized patients with COVID-19 had bacterial co-infections requiring antibiotics, 75% of patients were treated with antibiotics just in case they help. Antibiotic use ranged from 33% in the Western Pacific Region to 83% in the Eastern Mediterranean and the African Regions. “These findings underscore the important need to adequately resource the efforts to improve antibiotic prescribing globally, and are particularly relevant to discuss ahead of the upcoming UN General Assembly High-Level Meeting on Antimicrobial Resistance (AMR) to take place this September,” stated Dr. Yukiko Nakatani, WHO Assistant Director-General for AMR.

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

Upcoming Congressional Hearings and Markups

House Energy and Commerce Subcommittee on Health legislative hearing “Legislative Proposals to Increase Medicaid Access and Improve Program Integrity;” 10:00 a.m.; April 30

House Appropriations Subcommittee on Labor, Health and Human Services, and Education Member Day Hearing; 10:30 a.m.; April 30

Senate Armed Services Subcommittee on Personnel hearing to examine the Department of Defense’s efforts to ensure servicemembers’ access to safe, high-quality pharmaceuticals; the witness list can be found here; 2:30 p.m.; April 30

Senate Finance Committee hearing “Hacking America’s Health Care: Assessing the Change Healthcare Cyber Attack and What’s Next;” the witness list can be found here; 9:00 a.m.; May 1

House Energy and Commerce Subcommittee on Oversight and Investigation and Subcommittee on Health hearing to discuss gain-of-function research with EcoHealth Alliance President Dr. Peter Daszak; 10:00 a.m.; May 1

House Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss the Change Healthcare Cyberattack with Andrew Witty, CEO, UnitedHealth Group Inc.; 2:00 p.m.;

May 1

Senate Health, Education, Labor, and Pensions Committee hearing “What Can Congress Do to Address the Severe Shortage of Minority Health Care Professionals and the Maternal Health Crisis?” 10:00 a.m.; May 2

Recently Introduced Health Legislation

H.R.8084-To amend title XIX of the Social Security Act to require States to verify certain eligibility criteria for individuals enrolled for medical assistance quarterly, and for other purposes; Sponsor: Bilirakis, Gus M. [Rep.-R-FL-12]; Committees: House-Energy and Commerce

H.R.8089-To amend title XIX of the Social Security Act to require certain additional provider screening under the Medicaid program; Sponsor: Garcia, Mike [Rep.-R-CA-27]; Committees: House-Energy and Commerce

H.R.8094-To amend title XIX of the Social Security Act to modify certain asset recovery rules; Sponsor: Kean, Thomas H. [Rep.-R-NJ-7]; Committees: House-Energy and Commerce

S.Res.661-A resolution designating the week of April 15 through April 21, 2024, as “National Osteopathic Medicine Week”; Sponsor: Manchin, Joe, III [Sen.-D-WV]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.4201-A bill to amend title XVIII of the Social Security Act to modify the criteria for designation of rural emergency hospitals; Sponsor: Hyde-Smith, Cindy [Sen.-R-MS]; Committees: Senate-Finance

H.R.8106-To amend title XIX of the Social Security Act to increase transparency and expand coverage options with respect to home and community-based services under a Medicaid waiver; Sponsor: McMorris Rodgers, Cathy [Rep.-R-WA-5]; Committees: House – Energy and Commerce

H.R.8107-To amend title XIX of the Social Security Act to remove certain age restrictions on Medicaid eligibility for working adults with disabilities; Sponsor: Ciscomani, Juan [Rep.-R-AZ-6]; Committees: House – Energy and Commerce

H.R.8108-To amend title XIX of the Social Security Act to add a Medicaid State plan requirement with respect to the determination of residency of certain individuals serving in the Armed Forces; Sponsor: Kiggans, Jennifer A. [Rep.-R-VA-2]; Committees: House-Energy and Commerce

H.R.8109-To amend the Deficit Reduction Act of 2005 to make permanent the Money Follows the Person rebalancing demonstration; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House-Energy and Commerce

H.R.8110-To amend title XIX of the Social Security Act to make permanent the State option to extend protection against spousal impoverishment for recipients of home and community-based services under Medicaid; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House-Energy and Commerce

H.R.8111-To amend title XIX of the Social Security Act to ensure the reliability of address information provided under the Medicaid program; Sponsor: Miller-Meeks, Mariannette [Rep.-R-IA-1]; Committees: House-Energy and Commerce

H.R.8112-To amend title XIX of the Social Security Act to further require certain additional provider screening under the Medicaid program; Sponsor: D’Esposito, Anthony [Rep.-R-NY-4]; Committees: House-Energy and Commerce

H.R.8113-To amend title XIX of the Social Security Act to require reporting on certain directed payments under the Medicaid program; Sponsor: Griffith, H. Morgan [Rep.-R-VA-9]; Committees: House-Energy and Commerce

H.R.8114-To prohibit the Secretary of Health and Human Services from finalizing a rule proposed by the Centers for Medicare & Medicaid Services to place certain limitations on Medicaid payments for home or community-based services; Sponsor: Cammack, Kat [Rep.-R-FL-3]; Committees: House-Energy and Commerce

H.R.8115-To amend title XIX of the Social Security Act to allow for the deferral or disallowance of portions of payments for certain managed care violations under Medicaid; Sponsor: Sarbanes, John P. [Rep.-D-MD-3]; Committees: House-Energy and Commerce

H.R.8116-To amend title 28, United States Code, to limit the use of Federal funds for live tissue training for Department of Justice personnel; Sponsor: Dean, Madeleine [Rep.-D-PA-4]; Committees: House-Judiciary

H.R.8123-To amend the Federal Food, Drug, and Cosmetic Act to establish new prohibited acts relating to dietary supplements; Sponsor: Pallone, Frank [Rep.-D-NJ-6]; Committees: House-Energy and Commerce

E&C Schedule Hearing on Change Healthcare Cyberattack-Bipartisan leadership of the House Energy and Commerce Committee sent a letter to UnitedHealth Group, Inc. last week seeking information about the Change Healthcare cyberattack. “The health care system is rapidly consolidating at virtually every level, creating fewer redundancies and more vulnerability to the entire system if an entity with significant market share at any level of the system is compromised,” the committee leaders wrote. “In order to understand better the steps UnitedHealth has taken to address this situation, we request information about the impact of the cyberattack, the actions the company is taking to secure its systems, and the outreach to the health care community in the aftermath.” UnitedHealth’s CEO Andrew Witty will testify before Energy and Commerce’s Oversight and Investigations Subcommittee in a hearing scheduled for May 1 to discuss the cyberattack and how it has impacted patients and providers.

Cassidy Questions FDA Oversight of Clinical Decision Support Software-Senate Health, Education, Labor, and Pensions Committee Ranking Member Bill Cassidy (R-La.) has sent a letter to the Food and Drug Administration (FDA) criticizing the agency’s decision in a September 2022 guidance to classify clinical decision support (CDS) software as a medical device and to subject software developers to the FDA’s regulatory process. Cassidy argues that the move is not aligned with the agency’s statutory authority, highlighting that Congress excluded CDS software from being categorized as a medical device in the 21^st Century Cures Act. He expresses concerns about the implications of increased oversight of CDS on patient access to innovative medical technology, and notes that the FDA made the change without providing stakeholders an opportunity to submit feedback on the potential impacts of the policy. “This guidance unnecessarily calls into question the safety of these tools and expands the universe of entities regulated by FDA, many of which are small provider practices who have developed their own CDS tools…FDA’s guidance not only runs contrary to an explicit congressional directive but may jeopardize access to advanced tools that improve patient care,” the letter argues.

Buchanan Asks MedPAC to Rethink Approach to Digital Health Tools-Rep. Vern Buchanan (R-Fla.), Chair of the Ways and Means Subcommittee on Health, has sent a letter to the Medicare Payment Advisory Commission (MedPAC) encouraging the commission to rethink its approach to evaluating digital health tools and the use of artificial intelligence in the Medicare program. Buchanan expresses concerns that MedPAC’s current approach could punish providers for using, and innovators for developing, digital health tools that improve health outcomes and control costs. Buchanan argues that “for Medicare to meaningfully transition to value-based care, payment policies need to maximize efficiencies in care delivery and enhance patient safety using digital health tools.” The letter highlights the “quadruple aim” of digital health tools, and strongly encourages MedPAC to “incorporate digital health tools into future evaluations of Medicare policy recommendations and, in partnership with all stakeholders impacted by Medicare policy, ensure that its evaluations and recommendations related to digital health are inclusive of each of the quadruple aims.”

Democratic Senators Raise Concerns With Levemir Discontinuation-Sens. Jeanne Shaheen (D-N.H.), Raphael Warnock (D-Ga.), and Elizabeth Warren (D-Mass.) have sent a letter to the President and CEO of Novo Nordisk regarding the company’s recent decision to discontinue production of Levemir, one of three long-acting insulin products on the market. The letter highlights that access to affordable, in-demand biosimilar insulins will be further restricted by the discontinuation and the creation of significant barriers to demonstrating biosimilarity without a reference sample. The lawmakers ask Novo Nordisk about the supply chain constraints and issues related to formulary placement that led to the discontinuation of Levemir, and about how the company plans to ensure patient access to similar long-acting insulin products at similar cost-sharing without gaps in coverage.

GAO Releases New Report on State PBM Regulations-The Government Accountability Office (GAO) released a new report last week examining five states’ regulation of pharmacy benefit managers (PBMs). Each of the five states selected for review-Arkansas, California, Louisiana, Maine, and New York-have enacted a variety of laws to regulate PBMs, including fiduciary or duty of care requirements, drug pricing and pharmacy reimbursement requirements, transparency requirements, and pharmacy network and access requirements. The regulators interviewed by GAO generally agreed that broad regulatory authority was more effective than enacting specific statutory provisions, and also stressed the need for robust enforcement of PBM laws and effective penalties to enforce them.

CBO Releases Analysis of Medicare ACOs’ Past Performance and Future Directions-The Congressional Budget Office has released a new report summarizing recent research findings about accountable care organizations (ACOs) and the factors that have contributed to or limited their ability to achieve net budgetary savings for the Medicare program. The analysis found that certain types of ACOs are associated with greater savings, including ACOs led by independent physician groups, ACOs with a larger proportion of primary care providers, and ACOs whose initial baseline spending was higher than the regional average. CBO also outlines the factors that limit the savings from Medicare ACOs, including weak incentives for ACOs to reduce spending, a lack of the resources necessary for providers to participate in ACO models, and providers’ ability to selectively enter and exit the program on the basis of the financial benefits or losses they anticipate from participating.

PAs in Oregon to Rebrand as Physician Associates–Oregon has become the first state in the nation to legally allow physician assistants to use the title physician associate on their license. Other states, including Michigan and South Carolina, are considering similar measures. The change is opposed by the American Medical Association and other physician groups, who have expressed concerns about patient confusion around scope of practice. Oregon’s new law will take effect on June 6, 2024.

Congressional Retirements and Resignations-Rep. Jake LaTurner (R-Kan.) has announced that he will not seek re-election this November. LaTurner has served in Congress since 2021 and currently sits on the Homeland Security, Oversight and Reform, and Science, Space, and Technology committees.

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

Upcoming Congressional Hearings and Markups

House Appropriations Subcommittee on Labor, Health and Human Services, and Education Member Day Hearing; 10:30 a.m.; April 30

House Energy and Commerce Subcommittee on Oversight and Investigation and Subcommittee on Health hearing to discuss gain-of-function research with EcoHealth Alliance President Dr. Peter Daszak; time TBD; May 1

House Energy and Commerce Subcommittee on Oversight and Investigations hearing to discuss the Change Healthcare Cyberattack with Andrew Witty, CEO, UnitedHealth Group Inc.; 2:00 p.m.; May 1

Recently Introduced Health Legislation

H.R.7974-To amend the Federal Food, Drug, and Cosmetic Act to require labeling of food products containing insects, and for other purposes; Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House-Energy and Commerce

H.R.7994-To support the direct care professional workforce, and for other purposes; Sponsor: Dingell, Debbie [Rep.-D-MI-6]; Committees: House – Energy and Commerce; Education and the Workforce; Ways and Means; Judiciary; House Administration; Oversight and Accountability

H.R.7996-To amend title XIX of the Social Security Act to ensure Medicaid coverage of mental health services and primary care services furnished on the same day; Sponsor: Dunn, Neal P. [Rep.-R-FL-2]; Committees: House-Energy and Commerce

S.Res.647-A resolution recognizing the designation of the week of April 11 through April 17, 2024, as the seventh annual “Black Maternal Health Week”; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Health, Education, Labor, and Pensions

S.4131-A bill to reform Federal firearms laws, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate-Judiciary

S.4137-A bill to amend title XVIII of the Social Security Act to count a period of receipt of outpatient observation services in a hospital toward satisfying the 3-day inpatient hospital requirement for coverage of skilled nursing facility services under Medicare; Sponsor: Brown, Sherrod [Sen.-D-OH]; Committees: Senate-Finance

S.4147-A bill to continue to fund the IMPROVE initiative through the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and for other purposes; Sponsor: Butler, Laphonza R. [Sen.-D-CA]; Committees: Senate-Health, Education, Labor, and Pensions

S.Res.654-A resolution expressing concern about the elevated levels of lead in one-third of the world’s children and the global causes of lead exposure, and calling for the inclusion of lead exposure prevention in global health, education, and environment programs abroad; Sponsor: Cardin, Benjamin L. [Sen.-D-MD]; Committees: Senate-Foreign Relations

S.4159-A bill to amend the Public Health Service Act to encourage qualified individuals to enter the forensic pathology workforce, and for other purposes; Sponsor: Cornyn, John [Sen.-R-TX]; Committees: Senate – Health, Education, Labor, and Pensions

S.4169-A bill to establish and support primary care team education centers, and for other purposes; Sponsor: Kaine, Tim [Sen.-D-VA]; Committees: Senate-Health, Education, Labor, and Pensions

S.4174-A bill to amend title IV of the Public Health Service Act to direct the Secretary of Health and Human Services to establish a clearinghouse on intellectual disabilities, and for other purposes; Sponsor: Schmitt, Eric [Sen.-R-MO]; Committees: Senate-Health, Education, Labor, and Pensions

S.4178-A bill to establish artificial intelligence standards, metrics, and evaluation tools, to support artificial intelligence research, development, and capacity building activities, to promote innovation in the artificial intelligence industry by ensuring companies of all sizes can succeed and thrive, and for other purposes; Sponsor: Cantwell, Maria [Sen.-D-WA]; Committees: Senate-Commerce, Science, and Transportation

H.Res.1153-Recognizing the designation of the week of April 11 through April 17, 2024, as the seventh annual “Black Maternal Health Week”; Sponsor: Adams, Alma S. [Rep.-D-NC-12]; Committees: House-Energy and Commerce

H.R.8018-To require the Administrator of the Centers for Medicare & Medicaid Services and the Commissioner of Social Security to review and simplify the processes, procedures, forms, and communications for family caregivers to assist individuals in establishing eligibility for, enrolling in, and maintaining and utilizing coverage and benefits under the Medicare, Medicaid, CHIP, and Social Security programs respectively, and for other purposes. Sponsor: Cammack, Kat [Rep.-R-FL-3]; Committees: House – Energy and Commerce; Ways and Means

H.R.8025-To amend title 10, United States Code, to clarify roles and responsibilities within the Department of Defense relating to subconcussive and concussive brain injuries and to improve brain health initiatives of the Department of Defense, and for other purposes. Sponsor: Khanna, Ro [Rep.-D-CA-17]; Committees: House-Armed Services

H.R.8037-To continue to fund the IMPROVE initiative through the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and for other purposes; Sponsor: Underwood, Lauren [Rep.-D-IL-14]; Committees: House-Energy and Commerce

H.R.8042-To authorize the Secretary of Health and Human Services to award grants to qualified entities to support community paramedicine programs, and for other purposes; Sponsor: Cleaver, Emanuel [Rep.-D-MO-5]; Committees: House-Energy and Commerce

H.R.8049-To amend the Internal Revenue Code of 1986 to prohibit treatment of certain distributions and reimbursements for certain abortions as qualified medical expenses; Sponsor: Mooney, Alexander X. [Rep.-R-WV-2]; Committees: House-Ways and Means

H.J.Res.129-Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Departments of Labor, the Treasury, and Health and Human Services relating to “Short-Term, Limited-Duration Insurance and Independent, Noncoordinated Excepted Benefits Coverage”; Sponsor: Self, Keith [Rep.-R-TX-3]; Committees: House-Energy and Commerce; Education and the Workforce; Ways and Means

H.R.8064-To amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of hearing aids and related hearing services; Sponsor: Cartwright, Matt [Rep.-D-PA-8]; Committees: House-Energy and Commerce; Ways and Means

H.R.8065-To require the Secretary of Health and Human Services, acting through the Assistant Secretary for Preparedness and Response, to carry out a program under which the Secretary requires each regulated seller of a highly infectious agent to comply with certain logbook requirements, and for other purposes; Sponsor: Costa, Jim [Rep.-D-CA-21]; Committees: House-Energy and Commerce

H.R.8069-To amend the Public Health Service Act to encourage qualified individuals to enter the forensic pathology workforce, and for other purposes; Sponsor: Guest, Michael [Rep.-R-MS-3]; Committees: House – Energy and Commerce; Ways and Means

H.R.8075-To amend title XVIII of the Social Security Act to provide for Medicare coverage of staff-assisted home dialysis for certain hemodialysis and peritoneal dialysis patients and to ensure all patients are educated on modality options and receive the resources, information, and support to succeed on the modality of their choice, and for other purposes; Sponsor: Miller, Carol D. [Rep.-R-WV-1]; Committees: House-Energy and Commerce; Ways and Means

H.R.8078-To authorize Federal support of States in piloting interoperable State-based repositories of sepsis cases, and for other purposes; Sponsor: Sherrill, Mikie [Rep.-D-NJ-11]; Committees: House-Energy and Commerce

H.R.8080-To amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish and implement a department-wide after-action program and a risk communication strategy, and for other purposes; Sponsor: Torres, Ritchie [Rep.-D-NY-15]; Committees: House-Energy and Commerce

Bipartisan Privacy Rights Draft Released-House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) and Senate Commerce, Science and Transportation Chair Maria Cantwell (D-Wash.) jointlyreleaseda discussion draft for the American Privacy Rights Act. The legislation would set a national standard and minimize the data that companies can collect, keep, and use. It also would provide individuals with the right to opt out of targeted advertising and other data practices. The discussion draft provides enforcement by the Federal Trade Commission, State attorneys general, and consumers. Small businesses that are not selling customers’ personal information would be exempt. The discussion draft includes “health information” under the definition of “sensitive covered data.” Upon release of the draft, House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.) said “This is a very strong discussion draft, built on the foundation of years of hard work by the Energy and Commerce Committee to strengthen our nation’s data privacy laws.”

Aderholt Presses for Budget Reforms Before Vote on New Appropriations Leader-Rep. Robert Aderholt (R-Ala.) sent a Dear Colleague letter last week asking the House GOP to delay a vote to select the next chair of the House Appropriations Committee. Aderholt currently leads the Appropriations Subcommittee on Labor-Health and Human Services-Education. Rep. Tom Cole (R-Okla.) is widely considered the frontrunner to replace outgoing Appropriations Committee Chair Kay Granger (R-Texas). The GOP Steering Committee is scheduled to meet April 9 to select a new chair, but Aderholt urges his conference to first conduct an overhaul of the budget process before selecting a new leader. His letter recommends a focus on restoring regular order, strengthening bipartisanship, and promoting fiscal responsibility. “Instead of hastily selecting a new Appropriations chair, I believe that now is the time to focus on correcting the process and developing our theory of government on how we will manage our responsibilities,” Aderholt wrote.

CMS Finalizes 2025 MA Payment Update-The Centers for Medicare and Medicaid Services (CMS) finalized the calendar year 2025 rate announcement for the Medicare Advantage (MA) program last week in line with the agency’s January proposal. Payments to MA plans are projected to increase an average of 3.7%-totaling over $16 billion-from 2024 to 2025. The agency estimates that the federal government will pay between $500 and $600 billion in MA payments to private health plans in 2025. The rate announcement also finalizes updates to MA payment growth rates and changes to the MA payment methodology to improve payment accuracy. CMS also finalized concurrent changes to the structure of the Medicare Part D drug benefit to implement the Inflation Reduction Act’s $2,000 cap on annual out-of-pocket costs for people with Part D in 2025.

HHS Releases Drug Shortages White Paper-The U.S. Department of Health and Human Services (HHS) released a white paper last week outlining steps the administration has taken to prevent and mitigate drug shortages and proposing additional solutions for policymakers to consider. The paper focuses specifically on generic sterile injectables used in inpatient settings, though HHS acknowledges that the solutions considered in the paper may be applicable to other markets. HHS recommends further collaboration with the private sector to develop and implement a Manufacturer Resiliency Assessment Program and a Hospital Resilient Supply Program. The new programs would be aimed at increasing transparency in the market, linking purchasing and payment decisions to supply chain resilience practices, and incentivizing investments in supply chain resilience and diversification of the supply chain-including domestic manufacturing-to drive impactful change.

HSGAC Chairman Seeks Information on Private Equity Impact on ER Care-Senate Homeland Security and Governmental Affairs Committee (HSGAC) Chairman Gary Peters (D-Mich.) is requesting information from private equity firms about their impact on emergency department operations. Peters cites patient safety issues raised by emergency physicians about private-equity owned staffing companies and hospitals, highlighting that in some cases “physicians reportedly have been responsible for over 20 beds at a given time and patients routinely had a 16-hour wait time in the emergency department.” Peters also expresses concerns that companies “previously engaged in surprise billing may now consider other cost cutting efforts that more directly risk negatively impacting patient safety and care.” Peters sent letters to Team Health, Envision Healthcare, Apollo Global Management, US Acute Care Solutions, and Lifepoint Health.

E&C GOP Requests GAO Report on NIH Handling of National Security Concerns–Republicans on the House Energy and Commerce Committee are requesting that the Government Accountability Office “examine the extent to which the National Institutes of Health (NIH) adequately safeguards research funds from national security concerns related to the Chinese military or over the unethical use of human beings in research studies, especially from entities of concern in China.” The lawmakers highlight recent reports about the agency’s ability to screen for national security issues and vet foreign collaborators. They pose a series of questions aimed at better understanding the extent of current vulnerabilities and NIH’s ability to safeguard federal funding.

Grijalva Announces Cancer Diagnosis–Rep. Raul Grijalva (D-Ariz.) announced last week that he has been diagnosed with cancer. Grijalva had sought treatment several weeks ago for a persistent cough, which was initially diagnosed as pneumonia. “This diagnosis has been difficult to process, but I am confident in the vigorous course of treatment that my medical team has developed, and I’ve begun my journey to fight this cancer,” he stated. Grijalva does not plan to resign from Congress and will continue to work and run for reelection as he undergoes treatment.

Democratic Physicians on the Ballot This November-At least six Democratic doctors are running for the House of Representatives this election cycle, with many of their platforms focused on access to reproductive health and bringing down the cost of health care.

• Minnesota state senator Kelly Morrison, an OB-GYN, is running to replace retiring Rep. Dean Phillips (D-Minn.).
• Arizona state representative Amish Shah, an emergency physician, is running to flip Rep. David Schweikert’s (R-Ariz.) seat.
• Maxine Dexter, a pulmonary and critical care doctor, is running in the Democratic primary to replace retiring Rep. Earl Blumenauer (D).
• Tim Peck, an emergency physician, is running to flip Rep. Erin Houchin’s (R-Ind.) seat.
• Bob Lorinser, a family physician, is running in the Democratic primary for Michigan’s 1^st congressional district, a seat currently held by Rep. Jack Bergman (R-Mich.).
• Kristin Lyerly, an OB-GYN, is unopposed in the Democratic primary in the race to represent Wisconsin’s 8^th congressional district, a seat opened by the retirement of Rep. Mike Gallagher (R-Wis.).

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

Upcoming Congressional Hearings and Markups

Senate Appropriations Subcommittee on State, Foreign Operations, and Related Programs hearing “A Review of the President’s Fiscal Year 2025 Budget Request for the U.S. Agency for International Development;” 2:30 p.m.; April 9

Senate Finance Subcommittee on Health Care hearing “Closing Gaps in the Care Continuum: Opportunities to Improve Substance Use Disorder Care in the Federal Health Programs;” 2:30 p.m.; April 9

House Veterans’ Affairs Subcommittee on Technology Modernization oversight hearing “VA Supply Chain Modernization: Ready for Prime Time?” 3:00 p.m.; April 9

Senate Judiciary Committee hearing “Artificial Intelligence and Intellectual Property: Part III-IP Protection for AI-Assisted Inventions and Creative Works;” 10:00 a.m.; April 10

Senate Committee on Environment & Public Works hearing “Examining the State of Air Quality Monitoring Technology;” 10:00 a.m.; April 10

Senate Foreign Relations Committee hearing “FY 2025 United States Agency for International Development Budget Request;” 10::00 a.m.; April 10

House Energy and Commerce Subcommittee on Health hearing “Legislative Proposals to Support Patient Access to Telehealth Services;” 10:00 a.m.; April 10

House Appropriations Subcommittee on Homeland Security budget hearing “Fiscal Year 2025 Request for the Department of Homeland Security;” 10:00 a.m.; April 10

Senate Appropriations Subcommittee on Homeland Security hearing “A Review of the President’s Fiscal Year 2025 Budget Request for the Department of Homeland Security;” 2:30 p.m.; April 10

Senate Finance Committee hearing “Bolstering Chronic Care through Medicare Physician Payment;” 10:00 a.m.; April 11

House Oversight and Accountability Committee hearing “Oversight of the U.S. Food and Drug Administration;” 1:00 p.m.; April 11

House Appropriations Subcommittee on State, Foreign Operations, and Related Programs budget hearing “Fiscal Year 2025 Request for the United States Agency for International Development;” 1:30 p.m.; April 11

House Appropriations Subcommittee on Homeland Security Member Day hearing; 2:00 p.m.; April 11

House Energy and Commerce Committee hearing with EcoHealth Alliance President Dr. Peter Daszak; time TBD; May 1

Recently Introduced Health Legislation

H.R.7848-To update the National Action Plan for Adverse Drug Event Prevention to consider advances in pharmacogenomic research and testing, to improve electronic health records for pharmacogenomic information, and for other purposes. Sponsor: Swalwell, Eric [Rep.-D-CA-14]; Committees: House-Energy and Commerce

H.R.7834-To improve the licensing requirements for the retail sale of firearms, and for other purposes. Sponsor: Frost, Maxwell [Rep.-D-FL-10]; Committees: House-Judiciary

H.R.7855-To amend the Public Health Service Act to authorize rural residency planning and development grant programs, and for other purposes; Sponsor: Caraveo, Yadira [Rep.-D-CO-8]; Committees: House-Energy and Commerce

H.R.7856-To amend title XVIII of the Social Security Act to provide for coverage of the Medicare Diabetes Prevention program, and for other purposes; Sponsor: DeGette, Diana [Rep.-D-CO-1]; Committees: House-Energy and Commerce; Ways and Means

H.R.7858-To amend title XVIII of the Social Security Act to establish a Medicare incident to modifier for mental health services furnished through telehealth; Sponsor: James, John [Rep.-R-MI-10]; Committees: House-Energy and Commerce; Ways and Means

H.R.7863-To require the Secretary of Health and Human Services to issue guidance on furnishing behavioral health services via telehealth to individuals with limited English proficiency under Medicare program; Sponsor: Steel, Michelle [Rep.-R-CA-45]; Committees: House-Energy and Commerce

GAO Releases Report on Federal Improper Payments-The Government Accountability Office has released a new report on government-wide improper payments made in fiscal year 2023, finding that total improper payments declined by $11 billion from the prior fiscal year. According to the report, programs at the U.S. Department of Health and Human Services accounted for an estimated $100 billion of $236 billion in improper payments across all federal agencies. The Medicare program saw $51.1 billion in improper payments, while the Medicaid program saw $50.3 billion.

Wyden, Grassley Seek Details on UNOS Data Breach-Sens. Ron Wyden (D-Ore.) and Chuck Grassley (R-Iowa) sent a letter to the United Network for Organ Sharing (UNOS) last week regarding a November 2023 data breach that gave unauthorized access to at least 1.5 million patient records to Organ Procurement and Transplantation Network (OPTN) and DonorNet system users. The lawmakers outline the multiple prior concerns that they have raised regarding UNOS’ data security and its ability to operate critical information technology. Wyden and Grassley criticize UNOS’ “apparent inability to efficiently and effectively operate the OPTN” and request details about the November data breach by April 10.

Markey, Warren Push for Field Hearing on For-Profit Health Companies-Massachusetts Senators Ed Markey (D) and Elizabeth Warren (D) are once again calling on the head of a for-profit health system to testify at a field hearing on April 3^rd in their state about the impact of for-profit companies on patient access to health care. The lawmakers sent a letter to the CEO of Steward Health Care Systems following up on their initial invitation to testify before the Senate Health, Education, Labor and Pensions Subcommittee on Primary Health and Retirement Security last month. “Investing in and operating a health care system includes a responsibility to the public,” the letter states. “You must answer for Steward’s current financial insecurity and its impact on access to health care.”

Democrats Comment on Abortion, EMTALA in Amicus Brief-More than 250 congressional Democrats have filed an amicus brief ahead of a case in which Supreme Court justices will consider whether Idaho’s near-total abortion ban is subject to the Emergency Medical Treatment and Labor Act’s (EMTALA) requirements that abortion be offered when it constitutes the necessary stabilizing treatment for a pregnant patient experiencing a medical emergency. “If this Court allows Idaho’s near-total abortion ban to supersede federal law, pregnant patients in Idaho will continue to be denied appropriate medical treatment, placing them at heightened risk for medical complications and severe adverse health outcomes,” the brief states. The lawmakers also caution that “health care providers, forced to let Idaho’s abortion law take precedence over their medical judgment about their patients’ best interests, will continue their exile from Idaho, creating maternity-care “deserts” all over the state.” The brief was led by Sens. Chuck Schumer (D-N.Y.), Patty Murray (D-Wash.), Ron Wyden (D-Ore.), and Dick Durbin (D-Ill.); and Reps. Hakeem Jeffries (D-N.Y.), Katherine Clark (D-Mass.), Frank Pallone (D-N.J.), Jerry Nadler (D-N.Y.), Diana DeGette (D-Colo.), and Barbara Lee (D-Calif.).

White House Releases Memo on Use of AI-The White House released the first government-wide memo for federal departments and agencies on the use of artificial intelligence (AI). The memorandum directs agencies to advance AI governance and innovation while managing risks from the use of AI, particularly those affecting the rights and safety of the public, and follows President Joe Biden’s October 2023 Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. Agencies will be required to designate a chief AI officer within 60 days to coordinate the use of AI with existing officials and organizations within the agency. The memo also outlines requirements for the creation of publicly reported, annual AI use case inventories, including an identification of which use cases are safety-impacting and rights-impacting, and how agencies are working to manage those risks.

Congressional Retirements and Resignations-Rep. Annie Kuster (D-N.H.) will not seek re-election this year. Kuster has served in Congress since 2013 and currently sits on the House Energy and Commerce Committee and Health Subcommittee. She also chairs the centrist New Democrat Coalition. House Democratic leadership touted Kuster’s leadership in addressing the opioid crisis and lending a voice to survivors of sexual assault following her retirement announcement.

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

Upcoming Congressional Hearings and Markups

Senate Health, Education, Labor, and Pensions (HELP) Committee field hearing “When Health Care Becomes Wealth Care: How Corporate Greed Puts Patient Care and Health Workers at Risk;” 11:00 a.m.; April 3

Senate Foreign Relations Committee hearing “FY 2025 United States Agency for International Development Budget Request;” 10::00 a.m.; April 10 

Recently Introduced Health Legislation

S.Res.625-A resolution recognizing the week of March 17 through March 23, 2024, as “National Poison Prevention Week” and encouraging communities across the United States to raise awareness of the dangers of poisoning and promote poison prevention; Sponsor: Brown, Sherrod [Sen.-D-OH]; Submitted in the Senate, considered, and agreed to without amendment and with a preamble by Unanimous Consent.

S.4054-A bill to require entities to meet minimum cybersecurity standards to be eligible for Medicare accelerated and advance payment programs if the reason for the need for such payments is due to a cybersecurity incident; Sponsor: Warner, Mark R. [Sen.-D-VA]; Cosponsors: (0) Committees: Senate-Finance

S.4060-A bill to improve maternal health policies in correctional facilities, and for other purposes; Sponsor: Booker, Cory A. [Sen.-D-NJ]; Committees: Senate-Judiciary

S.4063-A bill to establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan; Sponsor: Schatz, Brian [Sen.-D-HI]; Committees: Senate-Finance

S.4065-A bill to prohibit discrimination in health care and require the provision of equitable health care, and for other purposes; Sponsor: Padilla, Alex [Sen.-D-CA]; Committees: Senate-Health, Education, Labor, and Pensions

H.R.7808-To amend title XIX of the Public Health Service Act to provide for prevention and early intervention services under the Block Grants for Community Mental Health Services program, and for other purposes; Sponsor: Pfluger, August [Rep.-R-TX-11]; Committees: House-Energy and Commerce

H.R.7809-To establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan; Sponsor: Schrier, Kim [Rep.-D-WA-8]; Committees: House-Energy and Commerce; Ways and Means

H.R.7812-To Direct the Secretary of Health and Human Services to carry out a grant program to support the establishment of a national, toll-free telephone helpline to provide information and assistance to parents, caregivers, and youth to prevent child abuse and strengthen families; Sponsor: Torres, Norma J. [Rep.-D-CA-35]; Committees: House-Education and the Workforce

H.R.7814-To amend the Internal Revenue Code of 1986 to exclude from gross income certain federally subsidized loan repayments for dental school faculty; Sponsor: Van Drew, Jefferson [Rep.-R-NJ-2]; Committees: House-Ways and Means; Energy and Commerce

H.R.7815-To authorize the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to award grants to expand and improve maternal health care services, and for other purposes; Sponsor: Waters, Maxine [Rep.-D-CA-43]; Committees: House-Energy and Commerce

H.R.7820-To amend the Public Health Service Act to direct the Secretary of Health and Human Services to conduct a public health education, awareness, and outreach campaign to enhance access to abortion and related health services. Sponsor: Crockett, Jasmine [Rep.-D-TX-30]; Committees: House-Energy and Commerce

H.R.7823-To amend the Federal Food, Drug, and Cosmetic Act to require a warning label advising that the effects of mifepristone can be counteracted, to amend the Public Health Service Act to establish a hotline to provide information to women seeking to counteract the effects of mifepristone, and for other purposes. Sponsor: Miller, Mary E. [Rep.-R-IL-15]; Committees: House-Energy and Commerce

H.R.7827-To amend the Federal Food, Drug, and Cosmetic Act to encourage the development of vaccines to prevent, treat, or mitigate opioid, cocaine, methamphetamine, or alcohol use disorder, to establish an x-prize for the development of such a vaccine, and for other purposes. Sponsor: Schweikert, David [Rep.-R-AZ-1]; Committees: House-Energy and Commerce

H.R.7829-To amend title XVIII of the Social Security Act to improve the payment method for oxygen and oxygen related equipment, supplies, and services, to increase beneficiary access to oxygen and oxygen related equipment, supplies, and services, and for other purposes. Sponsor: Valadao, David G. [Rep.-R-CA-22]; Committees: House-Energy and Commerce; Ways and Means