Health Care Watch: January 6, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from January 1 – January 6. 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 January 3, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairman Brett Guthrie (R-KY), and Oversight & Investigations Subcommittee Chairman Morgan Griffith (R-VA) sent a letter to Food & Drug Administration (FDA) Commissioner Robert Califf regarding how the agency handles internal scientific disagreements. The letter expresses concern as to whether FDA scientists face possible retaliation for expressing differing scientific views. In the letter, the Chairs note they are prepared to pursue compulsory measures should FDA fail to respond in a timely manner.
Reps. Blaine Luetkemeyer (R-MO) and Doug Lamborn (R-CO) announced, on January 4 and 5, respectively, that they would not seek re-election.
On January 5, Majority Leader Steve Scalise (R-LA) announced that he will work remotely until February as he undergoes further cancer treatment. His absence, coupled with Rep. Bill Johnson’s (R-OH) resignation on January 21 will leave the GOP with a 218 vote majority.
The House returns on January 9.
Senate
The Senate returns on January 8.
REGULATORY UPDATE
On January 2, the Centers for Medicare & Medicaid Services (CMS) released alerts notifying Skilled Nursing Facilities (SNF), Long-term Care Hospitals (LTCH), and Inpatient Rehabilitation Facilities (IRF) of upcoming measure removals from the SNF Quality Reporting Program (QRP). Measures planned for removal differ by provider type.
On January 3, Department of Health & Human Services (HHS) Secretary Xavier Becerra held a virtual meeting with long-term care facility (LTCF) leaders to express concerns about low vaccination rates among nursing home residents. The conversation was a follow-up call from a previous HHS virtual meeting on December 21 with LTCF leaders to discuss the Centers for Disease Control and Prevention’s (CDC) December 2023 report finding that just 33% of LTCF residents were up to date with their COVID-19 vaccinations. During the call, Secretary Becerra requested that member facilities share their best practices with HHS and any information as to why residents or their guardians may be declining COVID-19 vaccinations.
On January 3, FDA published a draft report on how the agency will use best practices for the efficient prioritization, development, review, clearance, issuance, and use of guidance documents. As a part of the draft report and plan, FDA is also considering opportunities to further improve its guidance development and review and clearance practices, streamline processes for regulatory submissions to FDA through issuance of guidance documents, and implement innovative guidance development processes.
On January 3, FDA issued final guidance containing recommendations for firms reformulating drugs that contain carbomers made with benzene. The purpose of the guidance is to provide recommendations for applicants and manufacturers on what tests should be performed and what documentation should be submitted or available to FDA to support the reformulation of drug products that use carbomers manufactured with benzene.
On January 3, FDA issued final guidance to help small entities comply with a new rule governing direct-to-consumer (DTC) prescription drug advertisements. The guidance requires that DTC prescription drug advertisements on television or radio format that state the name of the drug and its conditions of use, present the major statement relating to side effects and contraindications in a clear, conspicuous, and neutral manner.
On January 3, the Office of Inspector General released a favorable advisory opinion regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would contract with a preferred hospital organization to provide discounts on the otherwise-applicable Medicare inpatient deductibles for its policyholders and, in turn, would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay.
On January 4, CMS issued an memo to Part D plan sponsors entitled “Introduction of Prescription Oral Antivirals for COVID-19 to the Commercial Market.” The guidance outlines expectations for plans to ensure claims for oral antivirals are processed appropriately and that beneficiaries access them at no cost sharing.
On January 5, the FDA announced that it has authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This authorization is the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada. Florida has estimated that it could save up to $150 million in its first year of the program, importing medicines that treat H.I.V., AIDS, diabetes, hepatitis C and psychiatric conditions. However, Florida must still meet various requirements before the program can commence. The state must send FDA details on the drugs it plans to import and must ensure that the drugs are potent and not counterfeit, as well as place an FDA-approved label on medications instead of those used in Canada. Finally, it is likely that the approval will face legal challenges, in particular by the Pharmaceutical Research and Manufacturers of America (PhRMA) that called FDA’s authorization “reckless” and a threat to public health.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Interoperability and Prior Authorization for MA Organizations, Medicaid and CHIP Managed Care and State Agencies, FFE QHP Issuers, MIPS Eligible Clinicians, Eligible Hospitals and CAHs (CMS-0057); Final Rule; 10/25/23
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
Advance Notice of Methodological Changes for Calendar Year 2025 for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies & Draft CY 2025 Part D Redesign Program Instructions; Proposed Rule; 12/1/23
Disproportionate Share Hospital (DSH) Third Party Payer (CMS-2445); Final Rule; 12/8/23
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
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
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Revised Draft Guidance for Industry (CDER, 2023-36); Notice; 12/1/23
Medical Devices; Quality System Regulation Amendments; Final Rule; 12/6/23
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability; Notice;1/4/24
OCR
Confidentiality of Substance Use Disorder Patient Records; Final Rule; 12/4/23
SAMHSA
Medications for the Treatment of Opioid Use Disorder; Final Rule; 10/24/23
UPCOMING HEARINGS
Senate
HELP Committee
January 25; 10:00 AM
Why Does the United States Pay, By Far, The Highest Prices in the World for Prescription Drugs?
OTHER POLICY NEWS
On January 2, MedPAC announced that it will host its monthly public meetings on January 11 and 12. The meetings will discuss payment adequacy and give status updates on topics including: hospital inpatient and outpatient services, dialysis, hospice, skilled nursing, and home health services, IRF services, Medicare Part D services, ambulatory services, and the Medicare Advantage (MA) program (including standardized benefits). More information regarding the timing and topics if the meetings can be found here.
On January 3, the Journal of the American Medical Association (JAMA) released a report finding that that average hospital cost to provide inpatient treatment during the COVID-19 pandemic in the US increased 26% over a 2-year period; costs to provide inpatient care increased even as care practices changed, vaccination rates increased, and the variants of concern evolved.