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# Medicare Finalizes Stem Cell Transplant Coverage For Myeloma Patients At Any ISS Stage
- URL: https://www.bullished.co/medicare-finalizes-stem-cell-transplant-coverage-for-myeloma-patients-at-any-iss-stage-45bf841d/
- Published: 2026-10-28T20:06:43.000Z
- Updated: 2026-10-28T20:06:43.000Z
- Description: CMS reconsidered one section of its transplant policy after a request from five groups, including the American Society of Hematology.
- Author: Matteo Parrino
- Tags: Markets, Industry: Healthcare, Topic: Health & Drug Regulation

The Centers for Medicare & Medicaid Services (CMS) finalized a wider national coverage policy for stem cell transplants in multiple myeloma, posting its [final decision memo](https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=323&ref=bullished.co) on Wednesday. Medicare will cover a single autologous transplant, which uses the patient's own stem cells, for patients with active disease at any stage under the International Staging System.

## Who qualifies under the new language

Coverage applies to patients who have active disease and meet the staging requirements. Staging is met by any stage under the International Staging System (ISS) and its revisions, or by Stage II or III under the Durie Salmon Staging System.

Active disease, as the International Myeloma Working Group defines it, means monoclonal plasma cells making up 10% of bone marrow or a biopsy-proven bony or extramedullary plasmacytoma. That is a tumor of monoclonal plasma cells in soft tissue outside the marrow and separate from bone. Patients also need evidence of at least one SLiM/CRAB myeloma-defining event.

CMS reconsidered only section B.II.b of the Stem Cell Transplantation national coverage determination, found at section 110.23 of the Medicare National Coverage Determinations Manual. The agency said the question was whether prognostic tools, particularly the ISS, predict outcomes after transplant well enough to change the criteria.

## Five requesters and a short comment window

Five groups made the request, according to the [tracking sheet](https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=323&ref=bullished.co). CMS accepted it on July 30 and posted a proposed memo the same day.

Comments on the proposal closed August 29\. The final memo followed on October 28.

## A disease of older adults

CMS described multiple myeloma as a relatively uncommon cancer in which malignant plasma cells build up in bone marrow and crowd out healthy cells. The median age at diagnosis is 65 to 74.

In the U.S., the agency cited approximately 36,000 new cases and 12,000 deaths a year. Staging systems, it noted, group patients by risk and expected outcomes using blood markers and tumor genetics, which helps clinicians set treatment intensity and monitoring.

The memo is final, and the new language replaces the earlier staging criteria in section B.II.b.

### Sources

- [Decision memo — Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (MM)](https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=323&ref=bullished.co) — Centers for Medicare & Medicaid Services
- [National coverage analysis tracking sheet — Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (MM)](https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=323&ref=bullished.co) — Centers for Medicare & Medicaid Services
- [Pfizer Cancer Therapy Shows Extended Progression-Free Survival in Multiple Myeloma Patients - Pfizer (NYS](https://www.benzinga.com/markets/biotech/26/10/62630251/pfizer-cancer-therapy-shows-extended-progression-free-survival-in-multiple-myeloma-patients?ref=bullished.co) — benzinga.com
- [Pfizer posts late-stage trial win for multiple myeloma drug | Seeking Alpha](https://seekingalpha.com/news/4657776-pfizer-posts-late-stage-trial-win-multiple-myeloma-drug?ref=bullished.co) — seekingalpha.com
- [Positive Data for Rina-S and Petosemtamab Strengthen Narrow-Moat Genmab's Oncology Strategy | Morningstar](https://www.morningstar.com/company-reports/1504635-positive-data-for-rina-s-and-petosemtamab-strengthen-narrow-moat-genmabs-oncology-strategy?listing=0P0000A5QU&ref=bullished.co) — morningstar.com
- [AbbVie Submits Biologics License Application (BLA) for Etentamig to U.S. FDA for Adults Living With Relapsed/Refractory Multiple Myeloma](https://www.prnewswire.com/news-releases/abbvie-submits-biologics-license-application-bla-for-etentamig-to-us-fda-for-adults-living-with-relapsedrefractory-multiple-myeloma-302919984.html?ref=bullished.co) — prnewswire.com