Health Care Watch: September 30, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from September 22 – September 28. 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 September 22, House Republicans released a stopgap spending bill which would fund the government through December 20. The House passed the legislation on September 25 in a 341-82 vote. The Senate passed the bill in a 78-18 vote shortly after. President Biden signed it into law on September 26.
On September 23, the House passed a variety of health care-related legislation including:
H.R.3433, the Give Kids a Chance Act of 2024 which provides a five-year reauthorization of the Food & Drug Administration’s (FDA) priority review voucher program, incentivizing drug development for rare pediatric diseases;
H.R.5526 the Seniors’ Access to Critical Medications Act of 2024 which would permanently allow independent doctors to send prescriptions to Medicare patients via mail;
H.R.2706 the Charlotte Woodward Organ Transplant Discrimination Prevention Act which would bar discrimination in the organ transplantation process based on mental and physical disabilities;
H.R.3884 the Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2023; and
S.133 the National Alzheimer's Project Act (NAPA) Reauthorization Act.
A list of all passed legislation can be found here.
Senate
On September 23, Health, Education, Labor & Pensions (HELP) Committee Ranking Member Senator Bill Cassidy (R-LA) sent letters to Lilly and Amgen requesting information as part of an ongoing investigation into how covered entities use and generate revenue from the 340B Drug Pricing Program. The letters request information to better understand the companies’ justifications for the restrictions on covered entities and how the restrictions affect distribution of 340B drugs.
On September 23, Finance Committee Chairman Ron Wyden (D-OR) sent letters to eight hospitals in states with abortion bans asking for more information following news reports that the hospitals delayed and denied women emergency reproductive health care in potential violation of the Emergency Medical Treatment and Active Labor Act (EMTALA). Chairman Wyden is requesting answers to questions about facilities’ policies and procedures.
On September 24, the HELP committee held a hearing examining the prices of GLP-1 drugs. During the hearing, members highlighted differences in GLP-1 drug prices between the United States and other countries, noting that certain GLP-1s are priced at $155 in Canada and $59 in Germany compared to $959 in the U.S. The committee also examined how pharmacy benefit managers (PBMs), insurance benefit designs, and regulatory obstacles contribute to elevated GLP-1 drug prices. Notably, Committee Chairman Bernie Sanders (I-VT) stated that the nation’s top PBMs have agreed to cover GLP-1s and lower prices if the manufacturers reduce their prices.
On September 25, Sens. Tammy Baldwin (D-WI) and Jeanne Shaheen (D-NH) introduced the Health Care Affordability Act. The legislation would make permanent the Affordable Care Act’s (ACA) enhanced premium tax credits (PTCs). The enhanced PTCs are currently set to expire at the end of 2025.
On September 25, the Senate voted unanimously to hold Steward Health Care CEO Ralph de la Torre in contempt of Congress, asking the Justice Department to pursue criminal charges against de la Torre for failing to comply with a congressional subpoena.
On September 25, the Homeland Security and Governmental Affairs Committee advanced the Risky Research Review Act, which would establish a Life Sciences Research Security Board within the Executive Branch. The independent board would oversee gain-of-function research and other high-risk life sciences research that potentially pose a threat to public health, safety, or national security.
On September 26, Finance Committee Chairman Wyden and Sen. Mark Warner (D-VA) released the Health Infrastructure Security and Accountability Act, which would require the Department of Health & Human Services (HHS) to develop and enforce a set of tough minimum cybersecurity standards for health care providers, health plans, clearinghouses and business associates, including stronger standards for systemically important entities and entities important for national security. The bill would also remove the existing cap on fines under the Health Insurance Portability and Accountability Act. A summary of the legislation can be found here.
On September 24, Finance Committee Chairman Wyden announced that HHS’ first Chief Competition Officer, Stacy Sanders, will service as Chief Health Adviser on the Senate Finance Committee majority staff beginning next month, replacing Shawn Bishop.
REGULATORY UPDATE
On September 20, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that aims to advance policies to promote the efficient operation of the Medicaid Drug Rebate Program (MDRP). This final rule includes policies to implement new statutory authorities included in the Medicaid Services Investment and Accountability Act of 2019 (MSIAA) to address situations in which manufacturers incorrectly report or misclassify their drugs in the MDRP. Additionally, the final rule also enhances MDRP integrity and strengthens policies that aim to ensure greater consistency and accuracy of drug information reporting, timely data collection, and efficient operation of the MDRP. As expected, the final rule did not include the Medicaid Best Price “stacking” policy that was contained in the proposed rule. A fact sheet detailing the final rule can be found here.
On September 20, CMS issued an information bulletin mandating that all states perform a compliance assessment and submit a plan to rectify any identified noncompliance with Medicaid and Children’s Health Insurance Program (CHIP) renewal requirements by the December 31, 2024. States must ensure full compliance with all federal renewal requirements by December 31, 2026.
On September 20, FDA approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. FluMist is the first vaccine to prevent influenza that does not need to be administered by a health care provider.
On September 20, FDA approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type C (NPC). Miplyffa, in combination with the enzyme inhibitor miglustat, is approved to treat neurological symptoms associated with NPC in adults and children 2 years of age and older. Miplyffa is the first drug approved by the FDA to treat NPC.
On September 24, CMS issued a final rule entitled, Medicare Program: Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023. The final rule is part of a larger strategy to address significant, anomalous, and highly suspect (SAHS) billing activity within Accountable Care Organizations (ACOs) reconciliation. A fact sheet detailing the final rule can be found here.
On September 24, the Health Resources and Services Administration (HRSA) announced nearly $75 million to support health care services in rural America. The funding will launch new opioid treatment and recovery services in rural communities, strengthen maternal health care in the South, and help rural hospitals stay open.
On September 24, HHS’ Administration for Strategic Preparedness and Response (ASPR), announced actions to increase the supply of mpox vaccine, supporting the U.S. Government’s commitment to make over a million combined doses of mpox vaccines available to the global mpox response. The U.S. announced that it is donating 1,000,000 doses to the international mpox response and ASPR is also loaning JYNNEOS manufacturer Bavarian Nordic 200,000 doses of ASPR-procured vaccine.
On September 24, FDA approved Aqneursa (levacetylleucine) for the treatment of neurological symptoms associated with NPC in adults and pediatric patients weighing at least 15 kilograms.
On September 26, CMS released comprehensive guidance to support states in ensuring that children with Medicaid and the Children’s Health Insurance Program (CHIP) coverage receive the full range of health care services they need. The guidance reinforces Medicaid’s Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) requirements and highlights strategies and best practices for states in implementing those requirements. Under Medicaid’s EPSDT requirements, eligible children and youth are entitled to a comprehensive array of prevention, diagnostic, and treatment services – including well-child visits, mental health services, dental, vision, and hearing services.
On September 26, HHS’ Advanced Research Projects Agency for Health (ARPA-H), announced funding for the Transforming Antibiotic R&D with Generative AI to stop Emerging Threats (TARGET) project, which will use AI to speed the discovery and development of new classes of antibiotics. The research will focus on three main areas: 1) using generative AI to expand the number of antibiotic candidates; 2) using deep learning to develop new screens to test a candidate’s suitability as a pharmaceutical; and 3) validating discoveries.
On September 26, HHS and the Substance Abuse and Mental Health Services Administration (SAMHSA) announced more than $1.5 billion in awards for fiscal year (FY) 2024 State Opioid Response (SOR), Tribal Opioid Response (TOR) and SOR/TOR Technical Assistance grants. The FY24 awards have an increased focus on services for transitional aged youth and young adults (ages 16-25 years); expand availability of medications for opioid use disorder (MOUD) in correctional settings; and emphasize the role of services that use a whole-person approach by considering an individual’s physical and mental health needs and their social supports.
On September 26, FDA approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. Cobenfy is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care
On September 26, FDA released a glossary of digital health and AI terms. The glossary is a compilation of commonly used terms in the digital health, artificial intelligence, and machine learning space and their definitions. The glossary is intended for general educational purposes and does not constitute agency guidance, policy, or recommendations.
On September 27, CMS issued the projected 2025 MA and Part D premiums for 2025. The average MA premium is expected to decrease from $18.23 in 2024 to $17.00 in next year and the average non-low income subsidy Part D premium to drop from $53.95 this year to $46.50 in 2025. the average CMS. Projects MA enrollment to climb to 37.5 million beneficiaries in 2025.
On September 27, HRSA issued a warning letter to Johnson & Johnson that the manufacturer will be terminated from participating in the federal 340B drug discount program unless it notifies HRSA by September 30 that it plans to scrap its plan to replace upfront drug discounts with a new rebate approach. HRSA also noted that it would ask HHS’ Office of Inspector General to take enforcement action if the manufacturer continues the program past the September 30 deadline.
WHITE HOUSE
On September 21, President Biden announced that the United States, Australia, India, and Japan are launching an effort to help end cancer in the Indo-Pacific, starting with cervical cancer and laying the groundwork to address other forms of cancer as well. The initiative is part of a broader set of announcements made at the Quad Leaders Summit. The Quad Cancer Moonshot will serve to strengthen the overall cancer care ecosystem in the Indo-Pacific by improving health infrastructure, expanding research collaborations, building data systems, and providing greater support for cancer prevention, detection, treatment, and care.
On September 23, First Lady Jill Biden announced that the Department of Defense (DoD) will commit $500 million annually toward women’s health research. The funding will support research into conditions that uniquely or disproportionately affect women, including rheumatoid arthritis, chronic fatigue, eating disorders and gynecological cancers.
On September 24, Vice President Kamala Harris voiced support for eliminating the Senate filibuster to pass a law to restore the protections of Roe v. Wade and secure abortion rights nationwide.
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
Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056); Final Rule; 6/27/24
HHS Notice of Benefit and Payment Parameters for 2026 (CMS-9888); Proposed Rule; 7/17/24
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Proposed Rule; 8/8/24
Appeal Rights for Certain Changes in Patient Status (CMS-4204); Final Rule; 8/22/24
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rate Changes (CMS-1808); Interim Final Rule; 9/13/24
Contract Year 2026 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4208); Proposed Rule; 9/20/24
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Finale Rule; 9/20/24
CY 2025 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1807); Final Rule; 9/25/24
CY 2025 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1809); Final Rule; 9/25/24
FDA
Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability; Notice; 7/9/24
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Notice; 8/26/24
Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Final Rule; 9/24/24
Notifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry; Notice; 9/26/24
REPORTS
Office of Inspector General (OIG)
On September 23, OIG released a report examining Medicare and Medicaid enrollees' access to MOUD in high-need areas. OIG found that in 2022, hundreds of counties in high need of MOUD services lacked office-based buprenorphine providers and opioid treatment programs and even in counties where MOUD providers did practice, they often did not treat any Medicare or Medicaid enrollees. Additionally, OIG found that factors that may influence MOUD providers’ ability and willingness to treat Medicare and Medicaid enrollees included Medicare Advantage (MA) prior authorization requirements, low Medicaid reimbursement rates, and inadequate public information about MOUD provider locations. OIG recommends that CMS: 1) geographically target efforts to increase the number of MOUD providers that treat Medicare enrollees in high-need counties; 2) geographically target efforts to increase the number of MOUD providers that treat Medicaid enrollees in high-need counties; 3) work with States to assess whether their Medicaid reimbursement rates for treatment with MOUD are sufficient to recruit and retain enough MOUD providers; and 4) work with SAMHSA to develop and maintain a list of active office-based buprenorphine providers.
On September 24, OIG released a report examining oversight of remote patient monitoring in Medicare. OIG found that the use of remote patient monitoring in Medicare increased dramatically from 2019 to 2022. OIG also found that about 43% of enrollees who received remote patient monitoring did not receive all three components of it, raising questions about whether the monitoring is being used as intended. OIG recommends that the CMS take the following steps to strengthen oversight of remote patient monitoring: 1) implement additional safeguards to ensure that remote patient monitoring is used and billed appropriately in Medicare; 2) require that remote patient monitoring be ordered and that information about the ordering provider be included on claims and encounter data for remote patient monitoring; 3) develop methods to identify what health data are being monitored; 4) conduct provider education about billing of remote patient monitoring; and 5) identify and monitor companies that bill for remote patient monitoring.
On September 25, OIG released a report examining Humana’s compliance with specific MA diagnosis codes. OIG found that for the eight high-risk groups covered by the audit, most of Humana’s submissions of the selected diagnosis codes to CMS for use in CMS’ risk adjustment program did not comply with Federal requirements. Specifically, for 202 of the 240 sampled enrollee-years, the diagnosis codes that Humana submitted to CMS were not supported by the medical records and resulted in $497,225 in overpayments. OIG estimates that Humana received at least $13.1 million in overpayments for 2017 and 2018. OIG recommends that Humana: 1) refund to the Federal Government the $6.8 million of estimated overpayments; 2) identify, for the high-risk diagnoses included in this report, similar instances of noncompliance that occurred before or after the audit period; and 3) continue to examine its existing compliance procedures.
ADDITIONAL POLICY NEWS
On September 25, the Association for Accessible Medicines (AAM) announced that its board of directors has chosen John Murphy to be the group’s new president and CEO. Murphy has prior experience working at the Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA).
On September 26, Kentucky Attorney General Russell Coleman filed a lawsuit against Express Scrips, claiming that the PBM colluded with opioid makers to boost sales of the addictive drugs and failed to manage suspicious volumes of the products.