Since Congress is in recess until after the midterm elections, we anticipate that this weekly Check-Up will be lighter on congressional news, but we will continue to report any notable updates in the healthcare space on the congressional, regulatory and judicial fronts.
Bill Introduced to Require CMS to Evaluate Drug Coverage Individually. On October 4, Reps. Buchanan (R-FL) and Barragán (D-CA) introduced legislation to require the Centers for Medicare & Medicaid Services (CMS) to evaluate treatments and cures individually and based on their own merits, rather than as a broad class of drugs.
The bill, known as the Mandating Exclusive Review of Individual Treatments (MERIT) Act (H.R. 9127), would clarify the use of the Medicare national coverage determination process and is a reaction to CMS’s decision earlier this year to restrict coverage for the Alzheimer’s disease drug Aduhelm. According to Rep. Buchanan, by making this unilateral decision, “CMS cast a very wide net by restricting coverage of any similar drugs in its class.”
As a senior member of the House Ways and Means Committee and a candidate for full committee chairman should Republicans gain control of the House in the midterm elections, Rep. Buchanan’s leadership on this issue is noteworthy and may be an indication of committee priorities in the 118th Congress.
CMS Releases RFI on National Directory of Healthcare Providers & Services. On October 5, CMS issued a request for information (RFI) on establishing a National Directory of Healthcare Providers & Services (NDH) that could serve as a centralized hub for healthcare provider, facility and entity directory information nationwide.
The RFI seeks input on the current state of healthcare provider directories and steps that CMS could take if the agency concludes that adequate legal authority exists to establish an NDH and proceeds to do so. The RFI also seeks comment on how the CMS-led directory could better serve patients, while reducing directory maintenance burden on providers and payers, by creating a single, centralized system promoting real-time accuracy for patients.
The RFI is open for a 60-day public comment period that closes on December 6.
CMS Releases Inflation Reduction Act Materials. On October 5, CMS released a fact sheet on the Inflation Reduction Act (IRA) that contains information about the Medicare, Medicaid, Children’s Health Insurance Program, and Health Insurance Marketplace provisions of the IRA, which President Biden signed into law on August 16.
CMS also released an IRA implementation timeline and frequently asked questions document, providing additional details about upcoming changes and benefits related to the IRA.
Earlier in the week, US Department of Health and Human Services (HHS) Secretary Becerra and CMS Administrator Brooks-LaSure issued statements on the implementation of Medicare Part B payment changes for certain biosimilars—one of the IRA’s first Medicare provisions to take effect. The IRA provides for a temporary increase in the add-on payment for qualifying biosimilars whose average sales price is not more than the price of the associated reference biological product. For more information on the IRA’s healthcare provisions, see our team’s summary.
Reproductive Healthcare Updates. On October 4, HHS, through its Office of Population Affairs, announced more than $6 million in grants to protect and expand access to reproductive healthcare. The funding includes Title X Family Planning Research grants, Research-to-Practice Center grants, and Teenage Pregnancy Prevention Evaluation and Research grants, and is intended to improve service delivery, promote the adoption of healthy behaviors and reduce existing health disparities.
The same day, President Biden and Vice President Harris convened the second meeting of the Administration’s Task Force on Reproductive Healthcare Access. These efforts are part of the Biden Administration’s ongoing response to the June 2022 Supreme Court decision overturning Roe v. Wade.
340B Payment Update. Our McDermott Will & Emery colleagues provide an update on the recent US District Court for the District of Columbia decision vacating the 2022 rule under which HHS reduced Medicare Part B payments on 340B drugs paid under the Outpatient Prospective Payment System (OPPS), restoring payments to the full OPPS rate.
As the McDermott article notes, typically the process for making changes to payment systems at CMS takes a significant amount of time. However, CMS has made comments to providers that the agency may be able to move faster than would typically be expected.
Congress is in recess until after the November 8 midterm elections. Regulatory developments are anticipated in the coming weeks as stakeholders look forward to the final payment rules for physicians and hospital outpatient services.
For more information, contact Debra Curtis, Kristen O’Brien or Erica Stocker.
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