March 27, 2023
This Week in Health Policy for March 27
This Week (March 27-31)
The House Energy & Commerce Health Subcommittee will hold a hearing on "Lowering Unaffordable Costs: Examining Transparency And Competition In Health Care."
The House Appropriations Committee will hold a budget hearing on "Fiscal Year 2024 Request for the Department of Health and Human Services."
The House Ways & Means Health Subcommittee will hold a hearing on "President Biden's Fiscal Year 2024 Budget Request with Health and Human Services Secretary Becerra."
The House Oversight and Accountability Subcommittee on Health Care and Financial Services will hold a hearing on "FDA Oversight Part I: The Infant Formula Shortage."
The House Appropriations Committee will hold member days
The House Appropriations Committee will hold a budget hearing on "Fiscal Year 2024 Request for the Department of Veterans Affairs."
The House Appropriations Committee will hold a budget hearing on "Fiscal Year 2024 Request for the Food and Drug Administration."
The House Ways & Means Work & Welfare Subcommittee will hold a hearing on "Welfare is Broken: Restoring Work Requirements to Lift Americans Out of Poverty."
The House Energy & Commerce Health Subcommittee will hold a hearing on "Fiscal Year 2024 Department Of Health And Human Services Budget."
Senate Health, Education, Labor and Pensions Committee will hold an executive session to consider several presidential nominations, including those for Equal Employment Opportunity Commission and the National Mediation Board.
Senate Finance Committee will hold a hearing on "An Oral Health Crisis: Identifying and Addressing Health Disparities."
Senate Finance Committee will hold a hearing on "Pharmacy Benefit Managers and the Prescription Drug Supply Chain: Impact on Patients and Taxpayers."
Last Week (March 20-24)
Health Care Highlights
FDA offers guidance for accelerated approval clinical trials for oncology. On Friday (March 24), the Food and Drug Administration (FDA) issued draft guidance providing recommendations on clinical trial design and data analysis for oncology drugs to be reviewed via the accelerated approval process.
White House launches hunger and disease effort. On Friday (March 24), the White House launched its challenge to work with private entities to end hunger and reduce diet-related diseases by 2030. As part of the initiative, the FDA issued a proposed rule to help reduce sodium in U.S. food and draft guidance with recommendations for food manufacturers on how to incorporate Dietary Guidance Statements on food labels.
ACA turns 13. On Thursday (March 23), President Biden delivered a speech celebrating the 13th anniversary of the Affordable Care Act's (ACA) passage and highlighting the ways the Biden administration has built on the ACA's coverage expansions. That same day, HHS released a report that showed nearly 15.6 million people were enrolled in exchange plans as of February 2023 and 18.8 million people were newly enrolled in a Medicaid expansion plan as of September 2022. The White House also released 51 fact sheets providing state-specific data on how Republican proposals to repeal the ACA would impact residents.
HRSA's proposal to modernize U.S. organ transplant system. On Wednesday (March 22), the Health Resources and Service Administration (HRSA) unveiled plans to overhaul the Organ Procurement and Transplantation Network (OPTN) and increase transparency into the organ matching process. As part of the initiative, HRSA unveiled a new data dashboard to centrally share information on the number of donors, waitlists, and transplant recipients. The proposal includes a new competitive bidding process for operations currently performed by the United Network for Organ Sharing (UNOS) under a single contract, as well as funding increases to update the OPTN IT systems.
North Carolina adopts Medicaid expansion. On Thursday (March 23), the North Carolina General Assembly voted to expand Medicaid to an estimated 600,000 North Carolina Adults with incomes below 133% of the federal poverty level. The bill, which Gov. Roy Cooper (D) is expected to sign, ties implementation of the expansion to the state's budget process, which state analysts say could lead to delays. If implemented, the move would make North Carolina the 40th state to expand Medicaid under the ACA.
Federal worker COVID-19 vaccine mandate remains on hold. On Thursday (March 23), the Fifth Circuit Court of Appeals in New Orleans upheld a Texas district court's nationwide injunction against the COVID-19 vaccine mandate for federal workers.
White House details biomanufacturing goals. On Thursday (March 23), the White House released a report that lays out "bold goals" around biotechnology and biomanufacturing, including plans to domestically produce at least a quarter of all active pharmaceutical ingredients for small molecule drugs in the next five years.
CMS extends MA Value-based Insurance Model. On Thursday (March 23), the Centers for Medicare and Medicaid Services announced it will extend the Medicare Advantage (MA) Value-Based Insurance Design (VBID) Model for five additional years, from calendar years 2025 through 2030, and introduce changes to support patients' health-related social needs and health equity.
HHS extends EUA authority. On Wednesday (March 22), HHS published a notice of amendment stating that it has revised the emergency declaration issued under the Federal Food, Drug, and Cosmetic Act to ensure emergency use authorizations (EUAs) issued during the public health emergency (PHE) can remain in place after the PHE declaration ends on May 11.
HRSA announced funding opportunity for nurse training programs. On Tuesday (March 21), the Health Resources & Services Administration announced a new grant funding opportunity totaling $8.9 million to support nurse training in clinical settings.
SAMHSA announces funding opportunity for behavioral health. On Friday (March 24), the Substance Abuse and Mental Health Services Administration (SAMHSA) announced two funding opportunities for Certified Community Behavioral Health Clinics (CCBHC), totaling $123.6 million, to help clinics implement new CCBHC programs and enhance and support existing programs.
Biden signs bill to declassify COVID-19 origin data. On Monday (March 20), President Biden signed into law the COVID-19 Origin Act, a bill that directs the Director of National Intelligence to declassify intelligence related to the origins of COVID-19.
Hearings, Markups, and Other Committee Action
Senate Health, Education, Labor and Pensions Committee helda hearing on "Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine." On Wednesday (March 22), the Committee held a hearing centered on Moderna's plan to increase the price of its COVID-19 MRNA vaccine to $130 per dose, up from the government's price of $26.36 per dose, as Moderna prepares to transition the drug from a government purchaser to the commercial market as part of the COVID-19 public health emergency winddown. During the hearing, lawmakers first heard testimony from Moderna's CEO Stéphane Bancel, who emphasized the increased costs Moderna would face in transitioning from a "pandemic" to an "endemic" disease response, as well as the overall value of the vaccine, as justification for the hike. In response, there was much debate among committee members as to the importance of maintaining an innovative U.S. drug market while preserving affordability and access to life saving drugs. Lawmakers also heard testimony from a panel of academics who shared their concerns regarding drug innovation and public accessibility.
Senate Finance Committee and Senate Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee held separate hearings on "The President's Fiscal Year 2024 Health and Human Services Budget." On Wednesday (March 22), the Senate Finance Committee and the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held separate hearings to discuss President Biden's fiscal year (FY) 2024 budget proposal for the Department of Health and Human Services (HHS). The hearings mark the beginning of a months-long appropriations process to fund HHS before the end of the fiscal year. Both committees heard testimony from HHS Secretary Xavier Becerra who defended the president's budget request and responded to wide-ranging questions from committee members, including those related to mental health and substance use disorders, HHS' handling of migrant children, proposed changes to the Medicare Advantage program, and more.
Senate Commerce, Science and Transportation Committee held a markup on "the Pharmacy Benefit Manager Transparency Act of 2023" and other legislation. On Wednesday (March 22), the committee voted 18-9 to advance the bipartisan Pharmacy Benefit Manager Transparency Act (S. 127). The bill would prohibit pharmacy benefit managers from engaging in so-called "spread pricing," which is a practice in which PBMs charge health plans and payers more for a prescription drug than the amount the pharmacy reimburses, and from clawing back reimbursements from pharmacies. The bill also would require PBMs to pass on 100% of rebates to health plans, add new transparency requirements, and authorize the FTC to enforce the policies. During the hearing, Ranking Member Ted Cruz (R-TX) and Sens. Marsha Blackburn (R-TN) and John Thune (R-SD) raised concerns about the bill's new FTC authorities, with Sen. Cruz saying it could further consolidate the PBM market by impeding smaller PBMs' ability to compete.
The Senate Committee on Veterans' Affairs helda hearing on "Strengthening Methods of Recruitment and Retention for VA's Workforce." On Wednesday (March 22), the Committee held a hearing that featured testimony from Tracey Therit, Chief Human Capital Officer, Department of Veterans Affairs (VA) and Jessica Bonjorni, Chief Human Capital Management, Veterans Health Administration. Ms. Therit discussed their implementation of The Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022 (PACT Act), which was signed into law on August 10, 2022, and applauded the bill's work to empower the VA to deliver additional care and benefits to millions of Veterans and their survivors. They noted that claims increased by more than 25% since enactment and said the VA executed a successful pilot of the new toxic exposure screening. They indicated that recruitment and retention is the VA's top priority and said they have implemented all provisions of the PACT Act except one — the pay waiver authority, which they are working towards. Committee members including Chairman Jon Tester (D-MT) and Jerry Moran (RKS) noted their concern about adequate compensation and keeping up with the private market, as well as issues with onboarding and addressing providers with low quality ratings. Sen. Tester also touted his bill, the VA Clinician Appreciation, Recruitment, Education, Expansion, and Retention Support (CAREERS) Act of 2023 (S. 10), which he said is aimed at bolstering recruitment and retention of clinicians, particularly those in rural areas, at the VA.
The House Energy & Commerce Committee held a markup and advanced five bills addressing the fentanyl crisis, shoring up the 988-lifeline and banning the use of QALYs. On Thursday (March 23), the Committee advanced five bills:
The House Ways & Means Health Subcommittee held a hearing on "Why Health Care is Unaffordable: The Fallout of Democrats' Inflation on Patients and Small Businesses." On Thursday (March 23), the Subcommittee held a hearing on factors driving health care inflation. During the hearing, Republican members spoke critically of the ACA, the Inflation Reduction Act's provisions to extend enhanced federal subsidies and the impact on inflation and health care costs. Democrats, meanwhile, spent their time defending the ACA and touting the coverage gains seen under the law. During the hearing, lawmakers heard from a panel of witnesses featuring small business owners and health policy experts. The small business owners spoke about their struggles to provide affordable health care for employees post-ACA and the policy experts discussed factors, including health care consolidation, that are driving high prices, and ways to ease those pressures.
Reports, Studies, and Journals
Congressional Budget Office: CBO's Projections of Federal Health Care Spending. CBO in a letter shared that it overestimated mandatory spending for health care in its 2010—2020 projections. CBO said most of the overestimated stemmed from an overestimate of per beneficiary spending in Medicare and Medicaid, as well as less-than-anticipated spending for Medicare Part D drugs and Medicaid long-term services.
JAMA: Perspectives of Patients About Immediate Access to Test Results Through an Online Patient Portal. The study, which is based on responses from more than 8,000 patients who accessed their test results via an online patient portal, found that more than 95% wanted to continue to receive test results through their portal, regardless of whether the results were normal or abnormal.
Annals of Internal Medicine: Worsening Spread of Candida auris in the United States, 2019 to 2021. The study, which is based on data from the Centers for Disease Control and Prevention, found drug resistant fungal infections tripled in the U.S. between 2019 and 2021to 1,471 cases. Of those cases, seven were resistant to all antifungal treatments.