Knowledge Base Article
June 2023 Coverage Updates
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Coverage Updates
June 7, 2023: Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndrome (MDS)
The CMS issued a National Coverage Analysis (NCA) Tracking Sheet. CMS has received a complete, formal request to reconsider NCD 110.23, they requested full coverage of allogeneic HSCT for individuals with MDS and the removal of the Coverage with Evidence Development (CED requirement currently tied to coverage for HSCT for Medicare beneficiaries with MDS. CMS is soliciting public comments relevant to the request and is accepting comments from 6/7/2023 – 7/7/2023. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=312
June 22, 2023: CMS Fact Sheet: Details of Plan to Cover New Alzheimer's Drugs
CMS notes that if the FDA grants traditional approval, then Medicare will cover the drug in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs. This fact sheet gives more details on how a registry will work to make sure coverage will be available for any Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease that received FDA traditional approval. https://www.cms.gov/files/document/fact-sheet-june-2023.pdf
June 22, 2023: CMS Proposed Transitional Coverage for Emerging Technologies (TCET) Pathway
On June 22, 2023 CMS announced a proposed Transitional Coverage for Emerging Technologies (TCET) pathway as part of its commitment to fostering innovation while ensuring faster and more consistent access to emerging technologies. In addition, CMS released three proposed guidance documents: 1) Coverage with Evidence Development; 2) Evidence Review and 3) Clinical Endpoints Guidance for Knee Osteoarthritis. Additional information on today’s releases can be found here: https://www.cms.gov/blog/transforming-medicare-coverage-new-medicare-coverage-pathway-emerging-technologies-and-revamped and https://www.cms.gov/newsroom/fact-sheets/notice-comment-transitional-coverage-emerging-technologies-cms-3421-nc
Education Updates
MLN Fact Sheet: Medicare Part D Vaccines
This MLN Fact Sheet was updated this month to clarify that Medicare Part B covers vaccines and vaccine administration and Part D patient cost-sharing may include a vaccine administration fee. https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/vaccines-part-d-factsheet-icn908764.pdf
Other Updates
June 5, 2023: OIG Publishes Spring 2023 Semiannual Report to Congress
The OIG notes that this semiannual report is intended to keep the HHS Secretary and Congress fully and currently informed of OIG’s crucial findings and recommendations during the reporting period October 1, 2022 through March 31, 2023. https://oig.hhs.gov/reports-and-publications/archives/semiannual/2023/spring-sar-2023.pdf
This material was compiled to share information. MMP, Inc. is not offering legal advice. Every reasonable effort has been taken to ensure the information is accurate and useful.
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