Health Care Watch: March 10, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from March 3 – March 10. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On March 3, the House and Senate Appropriations Committees released the text of the Consolidated Appropriations Act of 2024. The legislation includes policies to mitigate Medicare physician fee schedule cuts, improve funding for community health centers, delay cuts in Medicaid Disproportionate Share Hospital (DSH) payments and other non-controversial health policies. Specifically, the legislation would provide a 1.68% increase in Medicare payments to physicians, backdate funding to the beginning of the fiscal year, bring community health center funding to an annualized rate of $4.27 billion per year, and require state Medicaid programs to cover all forms medication-assisted treatment beyond 2025. A detailed summary can be found here.
On March 6, the House approved the six-bill government funding package, sending the bill to the Senate for passage. The Senate passed the legislation on March 8 and President Biden signed the bill on March 9, avoiding a partial government shutdown.
On March 6, the Ways & Means Committee held a markup of health care legislation and favorably reported:
H.R. 7513, the Protecting America’s Seniors’ Access to Care Act, which would prevent the Department of Health & Human Services (HHS) from finalizing its proposal to mandate that nursing homes maintain minimum staffing levels;
H.R. 5074, the Kidney PATIENT Act of 2023, which would delay the inclusion of oral-only drugs from being included in the Medicare dialysis payment bundle until 2027; and
H.R. 7512, the Real-Time Benefit Tool Implementation Act, which would require the Centers for Medicare & Medicaid Services (CMS) to implement electronic real-time benefit tools in Part D by January 1, 2027.
On March 6, leaders from the Energy & Commerce, Ways & Means, and Oversight and Accountability committees, along with the GOP Doctors Caucus Co-Chairs, sent a letter seeking a briefing from HHS Inspector General (IG) Christi Grimm and CMS Administrator Chiquita Brooks-LaSure regarding Medicare fraud schemes involving catheter billing. The letter request briefings from the HHS IG and CMS by March 20, 2024, regarding what steps are being taken to address this reported fraud and prevent its reoccurrence.
Senate
On March 5, Sen. John Barrasso (R-WY) announced he will pass on a bid for GOP Leader in the next Congress, instead pursuing the No. 2 job of party whip. His decision narrows the GOP leadership race down to Sens. John Thune (R-SD) and John Cornyn (R-TX), for the time being.
On March 5, Sen. Kyrsten Sinema (I-AZ) announced that she will not run for reelection this year, setting up a race between Democratic Rep. Ruben Gallego and Republican Kari Lake to succeed her.
On March 7, Health, Education, Labor, and Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) and Ranking Member Bill Cassidy (R-LA), along with a bipartisan group of senators, released a request for input from stakeholders on policies the Committee should consider during the reauthorization of the Older Americans Act (OAA). Specifically, the senators asked for feedback on the effectiveness of pandemic-era flexibilities, as well as policies enacted by the 2020 reauthorization, in responding to the needs of older adults across the country.
REGULATORY UPDATE
On March 4, CMS announced that all manufacturers participating in the first cycle of Medicare drug price negotiations have responded with counteroffers. This news comes after HHS sent initial offers on February 1, 2024. Negotiations will continue over the next several months. If HHS and a participating manufacturer agree on a maximum fair price by the end of the negotiation period, those new negotiated prices will be published by September 1, 2024, and take effect beginning in 2026.
On March 4, HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) released a fact sheet detailing the projected impact of the Inflation Reduction Act on lowering drug costs for Medicare Part D enrollees who live in rural areas. Among other findings, ASPE found that about 289,000 rural enrollees are projected to save $1,000 or more in 2025 thanks to the IRA’s new caps on out-of-pocket costs and other drug related provisions.
On March 5, the Justice Department’s Antitrust Division, Federal Trade Commission (FTC) and HHS jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over health care. The agencies issued a Request for Information (RFI) requesting public comment on deals conducted by health systems, private payers, private equity funds and other alternative asset managers that involve health care providers, facilities or ancillary products or services. The RFI also requests information on transactions that would not be reported to the Justice Department or FTC for antitrust review under the Hart-Scott-Rodino Antitrust Improvements Act. In addition to the launch of the RFI, all three agencies participated in a virtual public workshop that will explore the impact of private equity in health care and will discuss what the federal government is doing to address any harmful effects.
On March 5, HHS announced that it is aware that Change Healthcare – a unit of UnitedHealth Group (UHG) – was impacted by a cybersecurity incident in late February and stated that the agency’s first priority is to help coordinate efforts to avoid disruptions to care throughout the health care system. HHS stated that it is in regular contact with UHG leadership, state partners, and with numerous external stakeholders to better understand the nature of the impacts and to ensure the effectiveness of UHG’s response. On March 6, CMS released a statement regarding the cyberattack. CMS noted that it is actively examining their authority to help support providers and are actively working with states to do the same. CMS also stated that it is in frequent communication with UHG and will continue to press them to swiftly communicate with the health care sector and to offer better options for interim payments to providers.
On March 5, the Food & Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee votedunanimously to recommend that the agency approve three-strain flu vaccines for the 2024-2025 season.
On March 5, FDA cleared for marketing the first over-the-counter(OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels.
On March 5, FDA approved the first interchangeable biosimilar to Prolia (denosumab) and Xgeva (denosumab). Jubbonti (denosumab-bbdz) is an interchangeable biosimilar to Prolia for the treatment of osteoporosis in certain patient populations, and Wyost (denosumab-bbdz) is an interchangeable biosimilar to Xgeva for the treatment of bone complications from cancer.
On March 6, CMS announced that it is looking for nominations for individuals to serve on a technical expert panel (TEP) that will advise the implementation of Exchange Health Plan Quality Initiatives by providing input on topics such as public engagement efforts, guidance materials, data analysis and methodology, and measure set refinements. CMS is seeking individuals with differing perspectives and areas of expertise, specifically: rural healthcare, consumer/patient advocacy, healthcare for underserved communities, and health equity expertise. The TEP nomination period opens on March 1, 2024, and closes on March 15, 2024. The nomination form can be found here.
On March 6, HHS’ Health Resources and Services Administration (HRSA) announced the launch of nearly $50 million for Rural Opioid Treatment and Recovery Initiative and released the initiative’s funding application. Funding will support establishing and expanding comprehensive substance use disorder treatment and recovery services in rural areas, including by increasing access to medications for opioid use disorder, such as buprenorphine. Applications will be accepted through May 6, 2024, and can be found here.
On March 7, HHS’ ASPE released an Issue Brief to better understand the scope of current generic drug utilization in Part D as CMS’ Innovation Center works to develop the Medicare $2 Drug List (M2DL) Model. As background, the M2DL drug pricing model would create a “high-value” generic drug list that Part D plans could offer enrollees at a low, fixed copayment ($2 for a month’s supply) without restrictions (i.e., step therapy, prior authorization, quantity limits). ASPE found that in 2022, 43.3 million Part D enrollees (82 percent) filled 1.1 billion prescriptions for generic drugs. While most enrollees filled at least one prescription for $2 or less, most (54 percent) paid more than $2 for at least one generic drug. Over 6 million enrollees filled at least one prescription for over $20.
On March 8, FDA decided to delay its decision on Eli Lilly's experimental treatment for early Alzheimer's disease, donanemab, and stated that it will hold a meeting of outside experts to discuss its safety and efficacy. The date of the advisory committee meeting for donanemab has yet to be set by the FDA, resulting in a delay of potential drug approval beyond the first quarter of 2024.
On March 8, Amylyx Pharmaceuticals’ ALS drug, Relyvrio, failedto meet its primary goal of slowing disease progression in an ongoing Phase 3 clinical trial designed to confirm its effectiveness. Based on the data, Amylyx is voluntarily pausing promotion of Relyvrio, and said it will work with regulatory authorities and the broader ALS community to determine the appropriate next steps for the therapy — which may include voluntarily withdrawing it from the market.
On March 8, FDA approved a new indication for use for Novo Nordisk’s Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.
On March 8, CMS announced Utah’s extension of comprehensive coverage for postpartum individuals for a full 12 months through Medicaid and the Children’s Health Insurance Program (CHIP). Utah is the 45th state to be approved for the extended coverage.
White House
On March 4, the White House held a listening session on pharmacy benefit managers (PBMs). Attendees included National Economic Advisor Lael Brainard, Domestic Policy Advisor Neera Tanden, HHS Secretary Xavier Becerra, and Chair of the Federal Trade Commission Lina Khan. Participants highlighted reforms that could promote transparency and competition in pharmaceutical markets, support independent pharmacies, and lower drug costs. Participants also discussed a range of approaches used to lower costs across states and private employers.
On March 5, President Biden released a fact sheet detailing new actions aimed at lowering costs for Americans. Actions laid out in the fact sheet include the introduction of a Strike Force to crack down on unfair and illegal pricing. The strike force will be co-chaired by the Department of Justice (DOJ) and FTC and aim to strengthen interagency efforts to root out and stop illegal corporate behavior that increases prices through anti-competitive, unfair, deceptive, or fraudulent business practices. Additionally, President Biden stated that work will be done to eliminate junk fees and make health care markets more affordable and competitive.
On March 6, President Biden released a fact sheet that previews new drug pricing and other health policy proposals to Congress that the President will discuss in his State of the Union address and will be included in the President's Budget. Drug pricing proposals include calling on Congress to: increase the number of drugs Medicare can select for negotiation to 50 drugs per year, require the Medicare drug inflation rebates to extend to commercial drug sales, expand the $2,000 OOP cap to all private insurance, and limiting cost-sharing to $2 for high-value generic drugs for all Medicare plans. Other proposals include increasing access to high quality care through programs that keep health insurance premiums low, closing the Medicaid coverage gap, and cracking down on junk insurance surprise bills and fees and confusing health care pricing.
On March 7, President Biden gave his annual State of the Union Address. President Biden touched on many health-related topics with an emphasis on protecting reproductive freedoms and lowering drug costs for Americans. As indicated above, President Biden discussed expanding the number of drugs subject to Medicare price negotiations, extending prescription drug cost caps, and expanding the insulin cap. President Biden’s full remarks can be found here.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Proposed Rule; 11/9/23
Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421); Final Rule’ 12/19/23
Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (CMS-2439); Final Rule; 12/20/23
Ensuring Access to Medicaid Services (CMS-2442); Final Rule; 1/26/24
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rates (CMS-1808); Proposed Rule; 1/31/24
HHS Notice of Benefit and Payment Parameters for 2025 (CMS-9895); Final Rule; 2/15/24
FY 2025 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1810); Proposed Rule; 2/16/24
Short-Term, Limited-Duration Insurance; Independent, Noncoordinated Excepted Benefits Coverage; and Tax Treatment of Certain Accident and Health Insurance (CMS-9904); Final Rule; 2/22/24
Contract Year 2025 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4205); Final Rule; 2/22/24
FY 2025 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1806); Proposed Rule; 2/28/24
Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting (CMS-3442); Final Rule; 3/1/24
FY 2025 Inpatient Rehabilitation Facility (IRF) Prospective Payment System Rate Update and Quality Reporting Program (CMS-1804); Proposed Rule; 3/4/24
FY 2025 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1802); Proposed Rule; 3/5/24
FDA
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule; 8/29/23
Medical Devices; Laboratory Developed Tests; Final Rule; 3/1/24
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response Prior to a Declaration under Section 564; Draft Guidance for Laboratories and FDA Staff; Notice; 3/4/24
Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564.; Notice; 3/5/24
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 3/7/24
OCR
Rulemaking on Discrimination on the Basis of Disability in Health and Human Services Programs or Activities; Final Rule; 3/4/24
Health and Human Services Grants Regulation; Final Rule; 3/6/24
ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Proposed Rule; 1/18/24
REPORTS
Office of Inspector General (OIG)
On March 6, OIG released a snapshot of biosimilar cost and use trends in Medicare Part B. OIG found that that after biosimilar competition, both reference product and biosimilar prices fell, leading to lower costs for the Part B program and enrollees. Furthermore, while use of biosimilars in Part B has grown significantly, OIG found that opportunities exist to further reduce Part B and enrollee spending through increased use of more affordable biosimilars or with the implementation of different payment policies. OIG recommends that CMS pursue one or more payment changes that could further realize savings from biosimilars for Part B and enrollees.
On March 7, OIG released a report examining HRSA overpayments to providers under the phase 2 general distribution of the provider relief fund (PRF) program. OIG found that for all 150 sampled providers, HRSA made PRF payments to eligible providers. However, for 17 of the 150 sampled providers, HRSA made PRF payments that were not correctly calculated or were not supported by appropriate documentation. As a result, HRSA made $18.4 million in potential overpayments to the 17 sampled providers. On the basis of OIG’s sample results, OIG estimates that HRSA made $159.4 million in potential overpayments to providers. OIG made three recommendations to HRSA, including that HRSA conduct a review of the 17 sampled providers identified that had potential overpayments of $18.4 million and determine the amount of and seek repayment of any overpayments.
UPCOMING HEARINGS
House
Ways and Means Committee
March 12; 11:00 AM; 1100 Longworth
Hearing on Enhancing Access to Care at Home in Rural and Underserved Communities
March 18; field hearing in Dallas, TX on emergency care
March 20; time TBD; 1100 Longworth
Hearing on the President’s FY25 Budget Request
Witness: HHS Secretary Becerra
Energy and Commerce Health Subcommittee
March 12; 10:00 AM; 2123 Rayburn
Markup of 19 Health Related Legislative Proposals
Legislation to be considered:
H.R. 619, NAPA Reauthorization Act;
H.R. 620, Alzheimer’s Accountability and Investment Act;
H.R. 7218, Building Our Largest Dementia (BOLD)Infrastructure for Alzheimer's Act of 2024;
H.R. 5012, SHINE for Autumn Act of 2023;
H.R. 4581, Maternal and Child Health Stillbirth Prevention Act of 2023;
H.R. 2706, Charlotte Woodward Organ Transplant Discrimination Prevention Act;
H.R. 4646, SIREN Reauthorization Act;
H.R. 6160, To amend the Public Health Service Act to reauthorize a lifespan respite care program;
H.R. 6960, Emergency Medical Services for Children Reauthorization Act of 2024;
H.R. 7153, Dr. Lorna Breen Health Care Provider Protection Reauthorization Act;
H.R. 7251, Poison Control Centers Reauthorization Act of 2024;
H.R. 7224, To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program;
H.R. 7208, Traumatic Brain Injury Program Reauthorization Act of 2024;
H.R. 6829, Cardiomyopathy Health Education, Awareness, Research, and Training in the Schools (HEARTS) Act of 2023;
H.R. 7189, Congenital Heart Futures Reauthorization Act of 2024;
H.R. 7406, DeOndra Dixon INCLUDE Project Act of 2024;
H.R. 3916, SCREENS for Cancer Act of 2023;
H.R. 5074, Kidney PATIENT Act; and
H.R. 5526, Seniors’ Access to Critical Medications Act of 2023.
Senate
Finance Committee
March 14; 10:00 AM; 215 Dirksen
The President’s Fiscal Year 2025 Health & Human Services Budget
Witness: HHS Secretary Becerra
OTHER POLICY NEWS
On March 4, Perrigo announced that the first daily birth control pill, the Opill, will be available for purchase without a prescription later this month. Consumers will have the opportunity to purchase the Opill in a variety of sizes, including one-month and three-month packs, with a manufacturer's suggested retail price of $19.99 and $49.99, respectively.