Health Care Watch: September 3, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 25 – August 31. 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 26, Ways and Means Committee Chairman Jason Smith (R-MO), Budget Committee Chairman Jodey Arrington (R-TX), and Senate Budget Committee Ranking Member Chuck Grassley (R-IA) sent a letter to Congressional Budget Office (CBO) Director Phillip Swagel asking CBO to analyze the new Medicare Part D Premium (PDP) Stabilization Demonstration program. Specifically, the letter asks that CBO provide a detailed breakdown of: the estimated budgetary effects for the new demonstration for plan year 2025; the isolated budgetary effects for each of the demonstration’s stated components; and the average projected payout to individual PDP sponsors under the demonstration.
The House returns from its August recess on September 9.
Senate
On August 27, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT) released a statement following drugmaker Eli Lilly’s announcement to lower the list price for the starter dose of its weight loss drug Zepbound. Chairman Sanders stated that he looks forward to discussing the high cost of diabetes and weight-loss drugs with the CEO of Novo Nordisk at a HELP Committee hearing on September 24, and engaging with Eli Lilly to urge the company to further reduce the list prices of Zepbound and Mounjaro.
On August 27, Finance Committee Chairman Ron Wyden (D-OR) released a statement highlighting a new analysis from Finance Committee majority staff. The analysis of Medicare Part B drug spending found that the rate of price increases by manufacturers with drugs covered under Part B slowed significantly since the price inflation penalties went into effect in January 2023, resulting in $3 billion dollars in savings for seniors and taxpayers. Additionally, the analysis found that at least 770,000 older Americans with Medicare had a direct reduction in their coinsurance payment for a Part B drug that saw a price increase faster than the rate of inflation.
The Senate returns from its August recess on September 9.
REGULATORY UPDATE
On August 26, the Centers for Medicare & Medicaid Services (CMS) announced a new round of awards, totaling $100 million, to organizations vital to helping underserved communities, consumers, and small businesses find and enroll in quality, affordable health coverage through HealthCare.gov. CMS is awarding the grants, in advance of this year’s Marketplace Open Enrollment, to 44 Navigator grantees in states using HealthCare.gov. The grants are part of a commitment of up to $500 million over five years.
On August 26, the Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced over $65 million in grant awards and notices of funding opportunity to help address the mental health and substance use crises. The awards include $27.5 million through the Strategic Prevention Framework – Partnerships for Success (SPF-PFS) program to help Tribes, state and local governments, and colleges and universities to develop and deliver substance use prevention services.
On August 26, the Food and Drug Administration (FDA) expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older.
On August 27, HHS announced more than $558 million in funding to improve maternal health. The Health Resources and Services Administration (HRSA) is awarding more than $440 million in funding to expand voluntary, evidence-based maternal, infant, and early childhood home visiting services for eligible families across the country. Additionally, the Centers for Disease Control and Prevention (CDC) announced a new investment of $118.5 million, over five years, to 46 states, six territories, and freely associated states to continue building the public health infrastructure to better identify and prevent pregnancy-related deaths.
On August 27, HHS released a readout of HHS Secretary Xavier Becerra’s roundtable with government officials, hospital and clinical leaders, distributors, and representatives from Becton Dickinson and Company (BD) to discuss mitigation strategies and solutions to alleviate the shortage of blood culture media bottles. During the call, representatives from BD described actions taken to increase and stabilize production output over the past several months, supplement demand with BD BACTEC™ in glass vials and support customers with extended shelf life where possible.
On August 28, U.S. Surgeon General Dr. Vivek Murthy released a Surgeon General’s Advisory on the Mental Health and Well-Being of Parents, highlighting the urgent need to better support parents, caregivers, and families. The Surgeon General’s Advisory calls for a shift in culture, policies, and programs and provides recommendations for several stakeholders that can help reduce stress for and better support the mental health and well-being of parents and caregivers through policy changes, community programs, and individual actions.
On August 29, HHS, through SAMHSA, announced $81.3 million in grant awards, including more than $16 million to support the integration of primary and behavioral health care. The announcement also included more than $24 million to expand capacity of drug treatment courts. Additional awards will support Tribal behavioral health, advance prevention science, support communities of recovery, and connect people to care.
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
Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434); Final Rule; 3/22/24
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
·Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023 (CMS-1799); Final Rule; 8/23/24
FDA
Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability; Notice; 7/9/24
Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Stakeholders; Availability (2023-814); Notice; 7/25/24
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability; Notice; 7/25/24
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
OASH
Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act; 8/6/24; Proposed Rule
Public Health Service Policies on Research Misconduct; Final Rule; 8/7/24
OS
HHS Adoption of Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; Interim Final Rule; 8/22/24
REPORTS
Office of Inspector General (OIG)
On August 29, OIG released a report examining South Carolina invoice rebates to manufacturers for physician-administered drugs dispensed to enrollees of Medicaid and managed-care organizations (MCOs). OIG found that South Carolina did not always comply with Federal Medicaid requirements for invoicing manufacturers for rebates for physician-administered drugs dispensed to MCO enrollees. OIG found that South Carolina did not invoice for, and collect from manufacturers, rebates totaling $14.2 million. OIG recommends that South Carolina: 1) invoice for and collect manufacturers’ rebates totaling $12.2 million; 2) work with CMS to determine whether the claims for other multiple-source physician-administered drugs, totaling $1.9 million were eligible for rebates; 3) ensure that all physician-administered drugs eligible for rebates after the audit period are processed for rebates; and 4) continue to review and strengthen its internal controls to ensure that all physician-administered drugs eligible for rebates are invoiced.
On August 29, OIG released a report examining Utah Medicaid eligibility actions during the unwinding period. OIG stated that of the 193,009 enrollees who had their Medicaid eligibility renewed, or coverage terminated during April 1 through September 30, 2023, OIG sampled 140 enrollees and determined that Utah incorrectly completed Medicaid eligibility actions for 6 enrollees. OIG estimates that Utah incorrectly renewed eligibility or incorrectly terminated Medicaid coverage for 5,233 of the 193,009 enrollees during the audit period. OIG recommends that Utah redetermine Medicaid eligibility for the six sampled enrollees identified as having incorrect eligibility determinations, provide periodic training to caseworkers, identify and correct data limitations OIG identified, and strengthen policies and procedures to provide for greater accuracy in the monthly unwinding data reports.
HEARINGS
House
Ways & Means Committee
September TBD
Markup of health care legislation
Senate
HELP Committee
September 12; TBD
Testimony from Ralph De La Torre, CEO, Steward Health Care System
September 24; 10:00 AM; SD-562
ADDITIONAL POLICY NEWS
On August 26, the Medicare Payment Advisory Commission (MedPAC) announced the public meeting schedule for the 2024-2025 cycle. The schedule can be found here.
On August 29, Alison Barkoff, the senior official performing the duties of the Administration for Community Living (ACL) Administrator and Assistant Secretary for Aging, announced that she will be leaving HHS in early October.