Health Care Watch: February 25, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from February 18 – February 25. 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 February 16, Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-OH) sent a letter to Assistant Secretary for Legislation at the Department of Health & Human Services (HHS) Anne Egorin asking that HHS respond to a variety of questions regarding HHS’ compliance with the ongoing investigation regarding the origins of COVID-19. The letter threatens to subpoena HHS officials if responses are not made by March 1, 2024.
On February 21, Speaker Mike Johnson (R-LA) and Minority Leader Hakeem Jeffries (D-NY) announced a new bipartisan artificial intelligence (AI) task force with several members who are actively involved in health care policy. Leadership each appointed twelve members to the task force that represent key committees of jurisdiction and will be jointly led by Co-Chairs Jay Obernolte (R-CA) and Ted Lieu (D-CA). The task force will seek to produce a comprehensive report that will include guiding principles, forward-looking recommendations, and bipartisan policy proposals developed in consultation with committees of jurisdiction.
On February 21, Democrats on the Oversight and Accountability Committee, led by Ranking Member Jamie Raskin (D-MD), sent a letter to Teva, Pfizer, and Sandoz asking that the companies brief committee staff on ongoing shortages of cancer drugs such as carboplatin, cisplatin, and methotrexate.
On February 22, more than 150 House and Senate Democrats, led by Rep. Lois Frankel (D-FL), sent a letter to AHIP and UnitedHealth Group calling on them to meet coverage requirements for contraceptives under the Affordable Care Act. The letter states that plans should cover all Food & Drug Administration (FDA) approved contraceptives that don’t have a generic alternative without cost-sharing.
The House is in recess until February 28.
Senate
On February 21, Health, Education, Labor & Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a report outlining ways to improve privacy protections for Americans’ health data. The report comes after Ranking Member Cassidy requested information from stakeholders last year on how to enhance health data privacy protections covered by the Health Insurance Portability and Accountability Act (HIPAA) framework. The report outlines several proposals to modernize the HIPAA framework, safeguard health data not covered by HIPAA, and how to consider data that cannot be clearly defined as health or non-health.
REGULATORY UPDATE
On February 20, the Supreme Court rejected a motion filed by the attorney generals of Missouri, Kansas, and Idaho aiming to intervene in an upcoming case that will determine the future availability of the abortion pill mifepristone
On February 21, the Centers for Medicare & Medicaid Services (CMS) released the Medicaid Program Disproportionate Share Hospital (DSH) Third-Party Payer Final Rule. The final rule addresses recent legislative changes to the Social Security Act as a result of the Consolidated Appropriations Act, 2021 changes to the hospital-specific limit on Medicaid DSH payments. The final rule affords States and hospitals more clarity on how the limit will be calculated. Additionally, the final rule enhances administrative efficiency by making technical changes and clarifications to the DSH program.
On February 21, CMS announced that the February 2024 quarterly refresh for the Hospice Quality Reporting Program is now available on Care Compare and can be found here.
On February 21, HHS’ Office for Civil Rights (OCR) announced a settlement under HIPPA with Green Ridge Behavioral Health, LLC, a Maryland-based practice that provides psychiatric evaluations, medication management, and psychotherapy. The settlement resolves an investigation following a ransomware attack that affected the protected health information of more than 14,000 individuals. This marks the second settlement that OCR has reached with a HIPAA regulated entity for potential violations identified during an investigation following a ransomware attack.
On February 21, FDA issued the final guidance, Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment. This guidance supersedes the guidance of the same name initially published in September 2020. This guidance provides sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adults and adolescents.
On February 22, HHS’ OCR issued two Reports to Congress on HIPPA compliance and enforcement, specifically, on HIPAA Privacy, Security, and Breach Notification Rule Compliance and Breaches of Unsecured Protected Health Information. The reports, delivered to Congress, help regulated entities and their business associates in their HIPAA compliance efforts by sharing steps taken by OCR to investigate complaints, breach reports, and compliance reviews regarding potential violations of the HIPAA Rules. The reports also include important data on the number of HIPAA cases investigated, areas of noncompliance, and insights into trends such as cybersecurity readiness.
On February 23, CMS announced an upcoming webinar entitled Enrollee Advisory Committees Through a Health Equity Lens. The webinar will be held on March 14 from 2:30 – 3:30 PM ET. Registration can be found here.
White House
On February 21, First Lady Jill Biden announced that the Advanced Research Projects Agency for Health (ARPA-H) is launching its first-ever “Sprint for Women’s Health.” Over the next year, ARPA-H will invest $100 million to fund research surrounding women’s health and health outcomes.
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
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
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 February 20, OIG released a report detailing Medicare Advantage (MA) compliance of specific diagnosis codes that one MA organization, MediGold, submitted to CMS. OIG found that, with respect to the seven high-risk groups covered by the audit, most of the selected diagnosis codes that MediGold submitted to CMS for use in CMS' risk adjustment program did not comply with Federal requirements. Specifically, for 189 of the 210 sampled enrollee-years, the medical records that MediGold provided did not support the diagnosis codes and resulted in $469,907 in net overpayments. On the basis of the sample results, OIG estimates that MediGold received at least $3.7 million of net overpayments for 2017 and 2018. OIG recommends that MediGold: 1) refund to the Federal Government the $2.2 million of estimated net overpayments; 2) identify similar instances of noncompliance that occurred before and after the audit period and refund any resulting overpayments to the Federal Government; and 3) continue its examination of its existing compliance procedures to identify areas where improvements can be made.
Government Accountability Office (GAO)
On February 21, GAO released a report examining HHS’ efforts to address women’s worsening health outcomes. GAO found that maternal mortality and other adverse outcomes associated with pregnancy or childbirth worsened significantly in 2020 and 2021, as compared with 2018 and 2019. Disparities in maternal health outcomes persisted during the pandemic for certain groups, as the maternal mortality rate among non-Hispanic, Black or African American women was about 2.5 times greater than non-Hispanic, White women during these years. GAO recommends that HHS: 1) ensure the Maternal Health Blueprint's performance measurement strategy follows key practices; and 2) request that the Centers for Disease Control and Prevention (CDC) establish quantitative targets for the Perinatal Quality Collaborative program's near-term goals.
UPCOMING HEARINGS
House
Energy & Commerce Health Subcommittee
February 29; 10:00 AM; 2123 Rayburn
Legislative Proposals to Support Patients with Rare Diseases
Senate
Budget Committee
February 28; 10:00 AM; SD-608
No Rights to Speak of: The Economic Harms or Restricting Reproductive Freedom
Witnesses: Prof. Caitlin Myers, John G. McCullough Professor of Economics, Middlebury College; Leilah Zahedi-Spung, MD, Maternal Fetal Medicine, Complex Family Planning, Physicians for Reproductive Health; Mrs. Allie Phillips, Mom and Activist
OTHER POLICY NEWS
On February 20, Avalere released a report examining Medicare Part D plan tier placement of generic prescription drugs. Avalere found that over time, Part D plan sponsors placed an increasingly higher proportion of covered generic drugs on non-generic tiers. Specifically, the report states that Part D plan tier placement of generic prescription drugs has declined, from 64.5% in 2016 to 43.8% in 2024. Overall, the report finds that the proportion of generic products placed on non-generic tiers has increased over time but stabilized in recent years to 56%, noting that since 2016, there has been a 20.7 percentage point increase, and since 2019, there has been a 9.9 percentage-point increase.