Health Care Watch: September 2, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 27 – September 2. 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 August 29, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Ways & Means Committee Chairman Jason Smith (R-MO), and Senate Finance Committee Ranking Member Mike Crapo (R-ID) released a fact sheet critical of the Inflation Reduction Act’s (IRA’s) drug pricing provisions.
The House returns from its August recess on September 12.
Senate
On September 1, Majority Leader Charles Schumer (D-NY) told Senators that he hopes to consider legislation to lower the cost of prescription drugs (presumably via reforming pharmacy benefit managers) and insulin.
The Senate returns from its August recess on September 5.
REGULATORY UPDATE
On August 28, the Centers for Medicare & Medicaid Services (CMS) released the Medicaid Program and CHIP; Mandatory Medicaid and Children’s Health Insurance Program (CHIP) Core Set Reporting final rule. The final rule establishes requirements for mandatory annual State reporting of the Core Set of Children’s Health Care Quality Measures for Medicaid and CHIP.
On August 28, CMS released a study by Abt Associates that provides a comprehensive summary of results from the Nursing Home Staffing Study activities between May and December of 2022 and presents options for minimum nurse staffing requirements for consideration by CMS. The report found that there was no single staffing level that would guarantee quality care but estimates that higher staffing levels would lead to fewer hospitalizations and emergency room visits, faster care, and fewer failures to provide care.
On August 29, the Department of Health & Human Services (HHS) announced the first 10 drugs covered under Medicare Part D selected for the IRA’s Negotiation Program. Drug companies with a selected drug must agree to negotiations by October 1, 2023, and submit data to CMS by October 2, 2023. Negotiated maximum fair prices will be announced by September 1, 2024, and will become effective beginning in 2026. The 10 drugs selected for the first round of negotiations include: Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara, and NovoLog/Fiasp.
On August 30, CMS sent a letter to all 50 states and the District of Columbia requiring them to determine whether they have an eligibility systems issue that could cause individuals to be disenrolled from Medicaid or CHIP even if they are still eligible for coverage. The letter specifies that states must immediately take the following steps to avoid CMS taking action to bring states into compliance: 1) pause procedural disenrollments for those individuals impacted; 2) reinstate coverage for all affected individuals; 3) implement one or more CMS-approved mitigation strategy to prevent continued inappropriate disenrollments; and 4) fix state systems and processes to ensure renewals are conducted appropriately and in accordance with federal Medicaid requirements.
On August 30, the Food & Drug Administration (FDA) issued warning letters for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations to ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC. The letters reflect findings from FDA inspections of these facilities over the last several months.
On August 30, HHS Secretary Xavier Becerra declared a Public Health Emergency (PHE) for the state of Florida to address the health impacts of Hurricane Idalia and the Administration for Strategic Preparedness and Response (ASPR) deployed approximately 68 emergency response personnel to the state.
On August 31, HHS announced more than $450 million in funding for programs aimed at addressing the overdose epidemic. Awards include $80 million for rural communities in 39 states to support key strategies to respond to the overdose risk from fentanyl and other opioids, $279 million in Overdose Data to Action (OD2A) awards to states and localities to expand harm reduction strategies and link people to life-saving care, and $57.6 million across five grant programs to connect Americans who misuse substances to recovery and treatment supports.
On August 31, CMS extended the comment period on the Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022 proposed rule. Comments were originally due on September 5, 2023, but are now due on September 11, 2023. Comments can be made here.
On August 31, CMS announced its September ICD-10 Coordination and Maintenance committee meeting. The meeting will take place on September 12 and 13. The final agenda and meeting materials for the procedure code topics to be discussed at the meeting can be found here. Registration for the meeting can be found here.
On September 1, CMS released corrections to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; etc. final rule. Corrections are minor and can be found here.
On September 1, CMS released the Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting proposed rule. The proposed rule consists of three core staffing proposals: 1) minimum nurse staffing standards of 0.55 hours per resident day (HPRD) for Registered Nurses (RNs) and 2.45 HPRD for Nurse Aides (NAs); 2) a requirement to have an RN onsite 24 hours a day, seven days a week; and 3) enhanced facility assessment requirements. CMS also proposed to require states to collect and report on compensation for workers as a percentage of Medicaid payments for those working in nursing homes and intermediate care facilities. A fact sheet detailing the rule can be found here. Comments are due November 5, 2023, and can be made here.
WHITE HOUSE
On August 28, the Biden Administration released a statement highlighting efforts to support mental health services in K-12 education. Actions include expanding access to mental health support in schools including $2 billion for the Department of Education (ED) to create safe, inclusive learning environments for students and hire and train more mental health professionals for schools. ED is also working closely with HHS to further extend the reach of Federal mental health programs and investments into schools, and to leverage Medicaid funding to provide crucial health and mental health services at schools.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Medicare Secondary Payer and Certain Civil Money Penalties (CMS-6061); Final Rule; 3/1/22
Mandatory Medicaid and Children's Health Insurance Plan (CHIP) Core Set Reporting (CMS-2440); Final Rule; 7/28/23
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326); Final Rule; 7/31/23
CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(tt) of the Social Security Act (CMS-2447); Interim Final Rule; 8/16/23
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Federal Independent Dispute Resolution Process Fees (CMS-9890); Proposed Rule; 8/29/23
Independent Dispute Resolution Operations (CMS-9897); Proposed Rule; 8/29/23
FDA
Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format; Final Rule; 5/19/23
Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Certain Legally Marketed Medical Products: Questions and Answers (CDER, 2023-155); Notice; 7/13/23
Medical Devices; Laboratory Developed Tests; Proposed Rule; 7/26/23
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
REPORTS
Office of Inspector General (OIG)
On August 31, OIG released a report examining critical care for Medicaid enrollees with HIV. The report found that nationwide, 72,391 (or one-in-four) of the 265,493 Medicaid enrollees with HIV identified did not have evidence of one or more critical services in 2021, with the absence of viral load tests being the most common gap in care. Additionally, OIG found that 11,316 enrollees, or 4% of the 265,493 enrollees in Medicaid with HIV, did not have evidence of any of the three critical services as defined by Medicaid in 2021, which may mean that they were at greater risk of negative health impacts and HIV transmission. OIG made no recommendations.
UPCOMING HEARINGS
House
Energy & Commerce Committee
September 14, time TBD
Hearing on drug shortages
September 19; time TBD
Hearing on innovation
OTHER POLICY NEWS
On August 30, Emergent BioSolutions Inc. announced NARCAN® Naloxone HCl Nasal Spray 4 mg will be available on shelves nationwide and online beginning in September.
On September 7 and 8, the Medicare Payment Advisory Commission (MedPAC) will hold public meetings to discuss:
Context for Medicare payment policy;
Its Medicare Advantage (MA) workplan;
Standardized benefits in MA plans;
Improving the Commission’s estimate of MA coding intensity;
Acute Care Hospital at Home program; and
Ambulatory Surgical Centers.