Medicare now covers autologous stem cell transplant for active multiple myeloma at any ISS stage

On October 28, 2026, the Centers for Medicare & Medicaid Services posted its final decision memo for national coverage analysis CAG-00444R2, *Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (MM)*. It reconsiders one section of NCD 110.23, Stem Cell Transplantation: section B.II.b, the coverage criteria for autologous transplant in multiple myeloma.

The short version for a coding or billing desk is that the staging gate has moved. Since October 1, 2000, Medicare covered a single autologous transplant for myeloma only at Durie-Salmon stage II or III, and only when the disease was newly diagnosed or responsive and the patient had adequate organ function. The new manual language, effective October 28, 2026, accepts any stage under the International Staging System (ISS) and its revisions, keeps Durie-Salmon stage II or III as an option, and drops the response and organ-function rules.

What changed in NCD 110.23 section B.II.b

CMS's memo explains the response change directly. The original rule assumed that patients without at least a partial response before transplant would have poor outcomes, and CMS says a number of published studies have since refuted that. For organ function, CMS points to refinements in management and patient selection that now allow safer transplant in patients with comorbidities.

What "active disease" means in the new language

The new section B.II.b defines active disease the way the IMWG does. Both parts have to be there:

• Monoclonal plasma cells in the bone marrow of 10 percent or more, or a biopsy-proven bony or extramedullary plasmacytoma, and
• Evidence of at least one SLiM/CRAB myeloma-defining event

The memo spells out what those letters stand for. CRAB is hypercalcemia, renal impairment, anemia and bone lesions. SLiM adds three biomarkers: 60 percent or more monoclonal plasma cells in the marrow, an involved-to-uninvolved serum free light chain ratio of 100 or more, and two or more focal lesions on MRI.

CMS also explains why ISS stage I qualifies when Durie-Salmon stage I doesn't. Durie-Salmon stage I doesn't meet the SLiM/CRAB definition of active disease, while the ISS, R-ISS and R2-ISS apply only to patients already diagnosed with active myeloma. The memo notes that the precursor conditions, monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma, aren't considered active myeloma.

The final decision went further than the July proposal

CMS opened this reconsideration on July 30, 2026, after a formal request from the American Society of Hematology and others, and posted a proposed decision the same day. That proposal would have added ISS stage II or III but kept the newly diagnosed or responsive requirement and the organ-function requirement.

The 30-day comment period closed August 29, 2026, with 172 comments. CMS says most commenters supported modernizing the criteria but pushed for coverage of all patients with active disease or all ISS stages, and some asked CMS to drop the other requirements. The final memo does both: it adds ISS stage I and removes the response and organ-function rules.

What this decision doesn't change

• Tandem transplant. Multiple rounds of AuSCT for multiple myeloma remain on the nationally non-covered list in section C.
• Allogeneic transplant. CMS reconsidered only section B.II.b. Allogeneic stem cell transplant for myeloma is a separate part of NCD 110.23, which the NCD manual page still limits to Durie-Salmon or ISS stage II or III patients in an approved prospective clinical study.
• Newer risk tools. Some commenters worried that tools beyond ISS and its revisions would get inconsistent coverage. CMS's answer is that MACs will keep discretion over future risk assessment tools so they can keep pace as those tools are validated.
• Other indications. The remaining autologous indications, including primary AL amyloidosis, aren't part of this decision.

Coding and documentation notes

The decision memo doesn't list ICD-10-CM codes or claims processing instructions. When you code the diagnosis, the FY 2027 ICD-10-CM code descriptions file carries remission status in the fifth character of the multiple myeloma subcategory, C90.0-:

Code remission status from what the provider documents, not from the transplant plan. The ICD-10-CM code tells the payer what the patient has, but the new coverage criteria are clinical. The record has to show active disease, the myeloma-defining event and the stage under a named system (ISS, R-ISS, R2-ISS or Durie-Salmon). If the stage or the system isn't in the note, that's a query, not a guess.

Expect a lag before claims edits match the memo. As of November 2, 2026, the NCD 110.23 page in the Medicare Coverage Database still shows the prior manual language under transmittal 12813, and CMS's 2026 transmittals page lists no change request for this decision yet. CMS had already moved other NCD 110.23 stem cell business requirements out of October 2026 CR 14464 and into an April 2027 change request, according to Transmittal 13968. If a transplant with a date of service on or after October 28, 2026 is denied under the old criteria, keep a copy of the decision memo and its effective date with the appeal.