Returning to Certain Pre-COVID-19 Policies & Coverage of Monoclonal Antibodies for Alzheimer’s Disease Stakeholder Call

CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS) Special Edition – Thursday, April 7, 2022

 

Returning to Certain Pre-COVID-19 Policies & Coverage of Monoclonal Antibodies for Alzheimer’s Disease Stakeholder Call CMS Returning to Certain Pre-COVID-19 Policies in Long-term Care and Other Facilities Join CMS for a Stakeholder Call on the Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease CMS Returning to Certain Pre-COVID-19 Policies in Long-term Care and Other Facilities CMS is taking steps to continue to protect nursing home residents’ health and safety by announcing guidance that restores certain minimum standards for compliance with CMS requirements. Restoring these standards will be accomplished by phasing out some temporary emergency declaration waivers that have been in effect throughout the COVID-19 public health emergency (PHE). These temporary emergency waivers were designed to provide facilities with the flexibilities needed to respond to the COVID-19 pandemic. During the PHE, CMS used a combination of emergency waivers, regulations, and sub-regulatory guidance to offer health care providers the flexibility needed to respond to the pandemic. In certain cases, these flexibilities suspended requirements in order to address acute and extraordinary circumstances. CMS has consistently monitored data within nursing homes and has used these data to inform decision making. With steadily increasing vaccination rates for nursing home residents and staff, and with overall improvements seen in nursing homes’ abilities to respond to COVID-19 outbreaks, CMS is taking steps to phase out certain flexibilities that are generally no longer needed to re-establish certain minimum standards while continuing to protect the health and safety of those residing in skilled nursing facilities/nursing facilities. Similarly, some of the same waivers are also being terminated for inpatient hospices, intermediate care facilities for individuals with intellectual disabilities, and ESRD facilities. More Information: Full press release Quality, Safety, and Oversight memo Join CMS for a Stakeholder Call on the Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease Today, the Centers for Medicare & Medicaid Services (CMS) released a national policy for coverage of aducanumab (brand name Aduhelm™) and any future monoclonal antibodies directed against amyloid approved by the FDA with an indication for use in treating Alzheimer’s disease. From the onset, CMS ran a transparent, evidence-based process that incorporated more than 10,000 stakeholder comments and more than 250 peer-reviewed documents into the determination. As finalized in this two-part National Coverage Determination (NCD), Medicare will cover monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer’s disease that receive traditional approval from the Food and Drug Administration (FDA) under coverage with evidence development (CED). CMS, as a part of this decision, will provide enhanced access and coverage for people with Medicare participating in CMS-approved studies, such as a data collection through routine clinical practice or registries. Registry data may be used to assess whether outcomes seen in carefully controlled clinical trials (e.g., FDA trials) are reproduced in the real-world and in a broader range of patients. Any new drugs in this class that receive FDA traditional approval may be available in additional care settings that people with Medicare can use, such as an outpatient department or an infusion center. Secondly, for drugs that FDA has not determined to have shown a clinical benefit (or that receive an accelerated FDA approval), Medicare will cover in the case of FDA or National Institutes of Health (NIH) approved trials. Under this NCD, CMS will support the FDA by covering the drug and any related services (including, in some cases, PET scans if required by trial protocol) for people with Medicare who are participating in these trials. More Information: Complete press release Fact sheet on Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease Final NCD CED decision memorandum Stakeholder Call What: CMS invites you to join a stakeholder call on the Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease Decision Follows Robust Stakeholder Input and Creates Pathway for Enhanced Access and Coverage of Drugs that Receive Traditional FDA Approval When: April 11, 2022 at 11:00 AM ET How to register. Report a problem viewing this newsletter. The Medicare Learning Network®, MLN Connects®, and MLN Matters® are registered trademarks of the U.S. Department of Health and Human Services (HHS). Paid for by HHS.