HHS Issues Medicare Hospice Correction, FDA Device Classification, and NINDS Closed Review

Medicare Hospice Wage Index Correction

The Centers for Medicare & Medicaid Services (CMS) issued a correction to the final rule governing the FY 2027 Hospice Wage Index and Payment Rate Update, originally published in the August 3, 2026 Federal Register. The correction is effective October 1, 2026, and is treated as though it had been included in the original final rule.

The error originated in the calculation of the FY 2027 pre-floor, pre-reclassified Hospital Inpatient Prospective Payment Systems (IPPS) wage index, which was based on hospital cost reporting periods beginning on or after October 1, 2022 and before October 1, 2023. Under methodologies finalized in the FY 2027 IPPS/Long Term Care Hospitals Prospective Payment System final rule, rural emergency hospitals (REHs) — including hospitals that subsequently converted to REH status after the data period — are excluded from certain calculations, including the development of Medicare Severity Diagnosis-Related Group (MS-DRG) relative weights and the calculation of the standardized amount. The document states that CMS inadvertently treated a current IPPS hospital (CMS Certification Number 250078) as a hospital that had converted to REH status, thereby erroneously excluding its data from those calculations.

As a result of restoring that hospital's data and recalculating the FY 2027 IPPS pre-floor, pre-reclassified wage index, CMS recalculated the FY 2027 hospice wage index values for all Core-Based Statistical Areas (CBSAs) and rural areas, the wage index standardization factors, and subsequently the national payment rates for each level of hospice care, as well as the agency's impact analysis. Specific corrections were made to wage index values listed for CBSA 25980 (Hinesville, Georgia) and rural North Dakota, to Tables 1 through 4 covering Final FY 2027 Hospice RHC, CHC, IRC, and GIP Payment Rates, and to Table 22 covering the impact to hospices for FY 2027, including the impact percentage for hospices with greater than 20,000 RHC days. The corrected FY 2027 Hospice Wage Index file has been republished on the CMS website. The affected regulation is 42 CFR part 418.

CMS invoked the good cause exception under section 1871(b)(2)(C) of the Social Security Act and section 1871(e)(1)(B)(ii) to waive the standard notice-and-comment and delay-in-effective-date requirements, treating the corrections as effective as if included in the original August 3, 2026 publication.

FDA Classifies Vascular Autograft Solution as Class II

The Food and Drug Administration (FDA) issued a final order classifying the flushing and storage solution for vascular autografts at room temperature into class II (special controls) under 21 CFR part 876. The order is effective September 30, 2026, and the classification was applicable on October 4, 2023.

The action was initiated by a De Novo classification request submitted by Marizyme, Inc. on January 3, 2023, for its DuraGraft Vascular Conduit Solution. The document explains that any device not in commercial distribution before May 28, 1976, is automatically classified into class III and requires premarket approval unless FDA acts to classify or reclassify it. FDA used the De Novo classification process — authorized under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act — to move the device into class II with the establishment of special controls, which the agency determined provides a reasonable assurance of the device's safety and effectiveness.

The document states that FDA believes the action will enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens, by placing the device into a lower class than the automatic class III assignment. A further consequence of De Novo classification into class I or II, the document notes, is that the classified device can serve as a predicate for future devices of that type, allowing subsequent sponsors to use the less burdensome 510(k) premarket notification process rather than submitting a new De Novo request or premarket approval application.

NINDS Board of Scientific Counselors: Closed Meeting Scheduled

The National Institute of Neurological Disorders and Stroke (NINDS) has noticed a closed meeting of its Board of Scientific Counselors for November 8–9, 2027, to be held as a virtual meeting. On November 8, 2027, the session runs from 9:00 a.m. to 9:00 p.m.; on November 9, 2027, it runs from 10:00 a.m. to 3:00 p.m. Both sessions will address the same agenda: review and evaluation of personnel qualifications and performance, and the competence of individual investigators.

The meeting is closed to the public pursuant to section 552b(c)(6) of Title 5 U.S.C., on the grounds that the review, discussion, and evaluation of individual intramural programs and projects — including consideration of personnel qualifications, performance, and the competence of individual investigators — would, if disclosed, constitute a clearly unwarranted invasion of personal privacy. The listed address for both sessions is the Porter Neuroscience Research Center, Building 35A, 35 Convent Drive, Room GF-149, Bethesda, MD 20892. The contact person is Jeffrey S. Diamond, Ph.D., Acting Scientific Director, reachable through Program Analyst Caren Collins at 301-435-1896. Interested persons may submit written comments to the contact person. The notice was dated September 28, 2026.

What to Watch

• October 1, 2026: Effective date of the CMS correction to the FY 2027 Hospice Wage Index and Payment Rate Update (42 CFR part 418).
• September 30, 2026: Effective date of the FDA final order classifying the flushing and storage solution for vascular autografts at room temperature into class II (21 CFR part 876).
• November 8–9, 2027: Closed meeting of the NINDS Board of Scientific Counselors (virtual).

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