Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (MM)

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Medvedova, Eva	Title: MD Organization: OHSU Date: 08/24/2026 Comment: Patients with any stage of Multiple Myeloma should have access to an autologous stem cell transplant. No modern clinical trial excludes stage I Multiple Myeloma patients from ASCT eligibility. ISS Stage is not an appropriate tool to determine ASCT elibility.
Levy, Valerie	Date: 08/24/2026 Comment: As the [PHI Redacted] of a myeloma patient, I know how important it is to have as many treatments as possible at one’s disposal. Heartbreakingly, this disease tends to mutate, become uncontrolled by the therapy, and return. But in the earlier stages of the disease, before the immune system has become too affected, you have the best chance to achieve a lasting remission. Limiting the oncologist’s options could have serious and lasting negative consequences for a patient’s prognosis. Less As the [PHI Redacted] of a myeloma patient, I know how important it is to have as many treatments as possible at one’s disposal. Heartbreakingly, this disease tends to mutate, become uncontrolled by the therapy, and return. But in the earlier stages of the disease, before the immune system has become too affected, you have the best chance to achieve a lasting remission. Limiting the oncologist’s options could have serious and lasting negative consequences for a patient’s More
Minish, Cornelia	Date: 08/23/2026 Comment: Anyone with diagnosed Multiple Myeloma should have the ability to choose whether or not to have a stem cell transplant and have it covered by insurance. The ISS staging is irrelevant as the criteria is quite subjective. [PHI Redacted]
Arpaia, Didi	Date: 08/23/2026 Comment: [PHI Redacted] CMS has no business taking this option that myeloma specialists see as an essential part of treatment away from patients by not covering it through insurance. Doctors and patients must dictate their treatment, not insurance companies. Please do not let this important treatment get cut from insurance and thereby made unavailable to cancer patients. We have enough to manage already without this happening.
McDonald, Bernadette	Date: 08/23/2026 Comment: Removing Medicare coverage for AuSCT in ISS Stage 1 MM patients is not a good idea. This will unnecessarily endanger patient lives and it will result in poorer treatment outcomes for this patient population. Only clinicians and patients should be making these decisions. AuSCT at whatever stage is a useful and proven treatment modality and should not be curtailed based on an outdated and imprecise disease definition.
Khan, Abdullah	Title: Associate Professor Organization: The Ohio State University Date: 08/23/2026 Comment: Autologous hematopoietic stem cell transplant remains the standard-of-care for transplant-eligible newly-diagnosed multiple myeloma. We participated in the DETERMINATION trial and transplant was more impactful on the stage 1 patients than the stage 2/3 patients. Every treatment is individualized to the patient and that cannot be arbitrarily limited by one staging system.
Simms, Robert	Date: 08/23/2026 Comment: All patients should receive the same covered treatment no matter the stage of the Cancer. This treatment could stop the cancer before it gets to a later stage. This could save money and lives over the long run. Do not limit the covered treatment options for the patients of this cancer. [PHI Redacted]
Englishman, Loretta	Date: 08/23/2026 Comment: If the clinical team decides that transplant is the best course of action, it should be covered, regardless of stage. Having a patient wait until they are “sicker” is ludicrous and frankly malpractice. I would not be alive had my autologous stem cell transplant not been covered by Medicare. Please think about what you’re doing.
Schmidt, Timothy	Title: Physician Organization: University of Wisconsin Date: 08/23/2026 Comment: Lack of inclusion of ISS stage 1 disease for CMSe coverage of autologous stem cell transplant is gravely misguided. While I support moving away from the current language that theoretically could provide grounds to deny transplant for patients with Durie-Salmon stage 1 disease, this is not the way. ISS stage 1 disease, while usually a good prognostic factor, does not account for all potential risk factors, which is why over the past 20 years there have been many attempts to revise it. Many people with ISS stage 1 disease have occult high risk disease. Regardless, there is no study that shows that patients with ISS stage 1 disease do not benefit from transplant. The clinical decision whether to proceed with transplant is complex, and should be made with consultation by a physician who is well trained in transplant and knows how to apply complex data to an individualized patient decision. Lack of inclusion of ISS stage 1 disease by CMS has the potential to change that decision from one that is solely focused on the patient, to one where nonsensical insurance denials dominate the narrative. This is a bad decision and I urge CMS to cover transplant regardless of ISS stage. Less Lack of inclusion of ISS stage 1 disease for CMSe coverage of autologous stem cell transplant is gravely misguided. While I support moving away from the current language that theoretically could provide grounds to deny transplant for patients with Durie-Salmon stage 1 disease, this is not the way. ISS stage 1 disease, while usually a good prognostic factor, does not account for all potential risk factors, which is why over the past 20 years there have been many attempts to revise it. Many More
Omel, Jim	Title: Retired MD Date: 08/23/2026 Comment: [PHI Redacted] Please let patients and their doctors decide treatment, not changing definitions of staging. Every case of myeloma is unique. ASCT has proven to provide the greatest depth of response to disease over decades of time.
Dholaria, Bhagirathbhai	Title: Associate professor of medicine Organization: Vanderbilt University Medical Center Date: 08/23/2026 Comment: Proposed changes are going to cost CMS a lot more than expected savings during the life time of a patient with multiple myeloma. ASCT is a cheapest treatment (~46k for outpatient transplant) available for disease-free years gained, compared to alternate treatment options (1 year of lenalidomide ~200k). Upon relapse, these patients will need either CAR T therapy (~500k) or daratumumab/telistamab ( ~50k/month). ISS I should be allowed to have this treatment option.
Bal, Susan	Date: 08/23/2026 Comment: All patients with newly diagnosed multiple must have access to autologous stem transplant. International staging system scoring provides a crude assessment of prognosis of patients using simple tools. While numerous other superior prognostic tools are now available for prognostic characterization, none are perfect and many patients characterized as ‘standard risk’ at the time of diagnosis can have difficult to treat functional high risk disease. That being said, many ISS-1 do well and have the potential to derive long term disease control from ASCT. I urge CMS to remove any ISS criteria as a decision making tool and approve ASCT for all myeloma patients and let the physician and patient make the ultimate determination for each patient. Less All patients with newly diagnosed multiple must have access to autologous stem transplant. International staging system scoring provides a crude assessment of prognosis of patients using simple tools. While numerous other superior prognostic tools are now available for prognostic characterization, none are perfect and many patients characterized as ‘standard risk’ at the time of diagnosis can have difficult to treat functional high risk disease. That being said, many ISS-1 do well and More
Rosen, Richard	Date: 08/22/2026 Comment: The SCT is essentially in the treatment of Multiple Myeloma and other similar diseases to help put the disease into remission. Early detection and treatment even ar stage I is important arrest the disease before it reaches later stages. Eliminating coverage for this potential live saving procedure even at this early stage may cost lives and greatly impact the quality of life for many patients.
Brewer, Angie	Date: 08/22/2026 Comment: AuSCT should remain as a first line treatment option for all MM patients. The doctors involved in patient care should decide what treatment is best for patients. CMS should NOT restrict this. First line treatment for MM does not mean SCT is the first treatment provided; patients typically have to first endure many other drug treatments for months to even get to the point of AuSCT, then take maintenance meds after the SCT. This is all considered first line treatment. Why should MM patients wait to get sicker to receive standard of care? SCTs have been a life saver for MM patients. Keep this as an option for ALL stages of myeloma patients. Less AuSCT should remain as a first line treatment option for all MM patients. The doctors involved in patient care should decide what treatment is best for patients. CMS should NOT restrict this. First line treatment for MM does not mean SCT is the first treatment provided; patients typically have to first endure many other drug treatments for months to even get to the point of AuSCT, then take maintenance meds after the SCT. This is all considered first line treatment. Why should MM patients More
Giralt, Sergio	Title: Attending Physician Adult BMT Service Organization: Memorial Sloan Kettering Cancer Center Date: 08/22/2026 Comment: I strongly oppose the speci?c eligibility criteria that the proposed language carries forward — coverage limited to patients at ISS Stage II or Stage III who, for previously treated disease, must have achieved at least a partial response (de?ned as a 50% decrease in measurable paraprotein or bone marrow in?ltration), and who must have "adequate cardiac, renal, pulmonary, and hepatic function." (CMS Proposed Decision Memo, CAG-00444R2, NCAId 323) These three elements are inconsistent with the contemporary standard of care and with the evidence base on which that standard rests. Speci?cally, they would deny coverage to: (1) patients with ISS/R-ISS Stage I disease; (2) patients with primary refractory disease who have not reached a 50% (partial) response to induction; and (3) patients with renal, cardiac, or hepatic dysfunction. Each of these exclusions is contradicted by prospectively collected randomized-trial and large-registry data. I ask CMS to remove the Stage II/III restriction, remove the =50%/partial-response requirement, and replace the blanket "adequate organ function" exclusion with individualized, physician-directed risk assessment. The ISS and R-ISS are prognostic staging systems, not predictive biomarkers for transplant e?cacy. They describe expected outcomes for a population; they do not identify a subgroup that fails to bene?t from high-dose therapy. Randomized trials enrolled Stage I patients and showed bene?t across ISS strata These trials form the evidentiary basis for the contemporary guideline recommendation that transplant-eligible patients with newly diagnosed myeloma be o?ered AuSCT regardless of ISS stage. The proposed requirement that a patient achieve at least a partial response (a 50% reduction in paraprotein) before transplant would systematically exclude patients with primary refractory disease — the very population for whom intensi?cation is most often clinically indicated. Renal impairment should not be a contraindication to auto SCT, patients on dialysis and with poor renal function routinely receive high dose melphalan with similar outcomes than those with normal renal function. The decision to recommend autologous transplant should be left at the discretion of the treating physician and not be a blanket exclusion by CMS. Similarly patients with cardiac, pulmonary or hepatic comorbidities should be assessed by the treating physician who will decide based on his/her knowledge of the patient and their disease whether the risk / benefit ratio justifies autologous SCT Less I strongly oppose the speci?c eligibility criteria that the proposed language carries forward — coverage limited to patients at ISS Stage II or Stage III who, for previously treated disease, must have achieved at least a partial response (de?ned as a 50% decrease in measurable paraprotein or bone marrow in?ltration), and who must have "adequate cardiac, renal, pulmonary, and hepatic function." (CMS Proposed Decision Memo, CAG-00444R2, NCAId 323) These three elements are inconsistent wit More
James, Sara	Date: 08/21/2026 Comment: Do NOT limit our transportation for stage 1 treatment. This treatment is imperative to stop the progression of this incureable disease, You have no right to do this until you walk in our shoes, then you will understand.
Young, P	Date: 08/21/2026 Comment: Stem Cell Transplant should remain available to all Multiple Myeloma patients as it is a longstanding and more importantly, effective treatment for this incurable cancer!
Baldwin, Elissa	Date: 08/21/2026 Comment: This rule is frankly outrageous and unnecessary. An autologous transplant, in combination with chemotherapy treatments is the best way to achieve longer progression-free survival in multiple myeloma patients. If the doctor deems it necessary, they should be able to have this treatment. This isn’t just a new immune system, it is a recovery method using their own stem cells after high dose chemotherapy. They need that recovery option in place to be able to have the appropriate intensity of therapy. Removing this therapy option for stage 1 patients is absurd. You’re almost asking for people to get worse or relapse just to get a standard of care treatment. This isn’t right and it’s very unnecessary. We should be guided by the professionals and evidence-based medicine, not by whatever this is. Less This rule is frankly outrageous and unnecessary. An autologous transplant, in combination with chemotherapy treatments is the best way to achieve longer progression-free survival in multiple myeloma patients. If the doctor deems it necessary, they should be able to have this treatment. This isn’t just a new immune system, it is a recovery method using their own stem cells after high dose chemotherapy. They need that recovery option in place to be able to have the appropriate intensity of More
Zickel, Christine	Date: 08/21/2026 Comment: [PHI Redacted] Having the transplant has lessened the time and cost of seeing medical professionals. This opportunity should not change. CMS should adhere to medical and scientific advice.
Haimov, Barbara	Date: 08/21/2026 Comment: Let MYELOMA SPECIALISTS make the decisions that are best for their patients WITHOUT interference and I must say, that as someone who is currently battling MM with only a single kidney, NOT EVERY CASE IS THE SAME.
Zakoski, Tamara	Title: Mrs Date: 08/21/2026 Comment: No MM patient should be unable to get the treatment that works best for them. This cancer can become aggressive quickly and cause extensive bone damage. All treatments should be available to all MM patients. Do not limit SCT for anyone!
Miller, Lisa	Date: 08/21/2026 Comment: I think any one should be able to get a transplant at what ever stag they are at. I think it would be better at stage 1 because are bodies haven't been put through at much so you would heal betyer [PHI Redacted]
Zonder, Jeffrey	Title: MD Organization: Barbara Ann Karmanos Cancer Institute Date: 08/21/2026 Comment: I strongly oppose the proposed action of using R-ISS stage to determine eligibility for Autologous Stem Cell Transplantation (ASCT) as treatment for multiple myeloma. There is no data to suggest that patients with R-ISS stage 1 myeloma cannot benefit from ASCT as part of their therapy. In fact, the opposite is true. The largest randomized study of transplant conducted in the United States, the DETERMINATION trial, confirmed that patients with ISS stage 1 myeloma benefitted the most from ASCT relative to those with other stages. The proposal to deny access to ASCT for R-ISS stage 1 myeloma patients appears to be based on the extremely flawed assumption that "R-ISS stage 1" is equivalent to "Durie-Salmon Stage 1," which is INCORRECT. These are not the same, and many patients with R-ISS stage 1 myeloma can be quite symptomatic. No current evidence or published expert guidelines (including the NCCN and International Myeloma Working Group) recommend using R-ISS stage to determine selection of therapy or determination of candidacy for ASCT. Less I strongly oppose the proposed action of using R-ISS stage to determine eligibility for Autologous Stem Cell Transplantation (ASCT) as treatment for multiple myeloma. There is no data to suggest that patients with R-ISS stage 1 myeloma cannot benefit from ASCT as part of their therapy. In fact, the opposite is true. The largest randomized study of transplant conducted in the United States, the DETERMINATION trial, confirmed that patients with ISS stage 1 myeloma benefitted the most from More
Gorlin, Rebecca	Date: 08/21/2026 Comment: To not cover stem cell transplants for people with multiple myeloma is murder.
Weaver, Gina	Date: 08/21/2026 Comment: I do not agree with limiting Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (MM) to later stages.
Biltibo, Eden	Title: Assistant Professor Organization: Vanderbilt University Medical Center Date: 08/21/2026 Comment: High dose chemotherapy and autologous stem cell transplant prolongs progression free survival (time in remission) for all stages of multiple myeloma patients and should be accessible to all. In fact, the lower-stage lower-risk patients have higher chance of cure with treatment and should not be deprived of any myeloma treatment modalities.
Callander,M.D., Natalie	Title: Director, Myeloma Clinical & Cellular Therapy Prog Organization: University of Wisconsin Carbone Cancer Center Date: 08/21/2026 Comment: I have worked in the field of multiple myeloma for the past 4 decades. I have witnessed first-hand the life saving and life extending effects of autologous stem cell transplantation for our patients with multiple myeloma, regardless of stage. We have gone from a median survival of only 3 years at the start of the 21st century to more than 12, using treatment regimens that SPECIFICALLY INCORPORATE autologous stem cell transplantation, most recently the PERSEUS trial. This recent trial may have pushed median survival to more than 17 years. Since I started performing these procedures, we have been able to extend these to patients even as old as 80, those on dialysis, even frailer patients who have benefited from this therapy. Mortality from this procedure nationwide is 1% or less. Furthermore, ASCT is a cost effect method to treat myeloma, typically around $100k, as opposed to newer agents that cost more than $1,000,000 annually to administer, and are unavailable to many myeloma patients. It is crucial that CMS understand that staging systems like the ISS are outdated. In fact, lower stage patients have historically benefited the MOST from ASCT. In my clinic at UW the long-term survivors (ie more than 20 years) are ONLY those who have received ASCT during some time in their disease course. This procedure must remain available for every patient with multiple myeloma. Less I have worked in the field of multiple myeloma for the past 4 decades. I have witnessed first-hand the life saving and life extending effects of autologous stem cell transplantation for our patients with multiple myeloma, regardless of stage. We have gone from a median survival of only 3 years at the start of the 21st century to more than 12, using treatment regimens that SPECIFICALLY INCORPORATE autologous stem cell transplantation, most recently the PERSEUS trial. This recent trial may have More
Sanchez, Matias	Title: MD Organization: University of Illinois Date: 08/21/2026 Comment: Using risk stratification system to cover myeloma will Miss many patients that are not well represented by RISS prognostic system. There are many functionally high risk patients for example that will have good RISS and will not be candidates however the disease has poor prognostic without transplant
Anderson, Denyse	Date: 08/21/2026 Comment: I strongly urge you allow coverage for Stem Cell Transplant for ALL patients with multiple myeloma, regardless of the stage of the disease. This decision is between the doctor and patient. My [PHI Redacted] Stem Cell Transplant was a tremendous success getting him into remission. That is the best outcome one with this disease can hope for. Do not take this opportunity away from others.
Klein, Roxanne	Date: 08/21/2026 Comment: I believe that limiting AutSCT for any stage of multiple myeloma is a mistake and should not be considered or limited by CMS
Lynch, Michelle	Date: 08/21/2026 Comment: [PHI Redacted] A delay in SCT can have extremely negative impacts to the health and quality of life of MM patients. Do not limit our ability to choose an aggressive battle with this cancer.
Land, Maria	Date: 08/21/2026 Comment: This is a terrible idea. CMS has no business limiting long practice treatments, which have proven highly effective as a first time treatment. This will cost lives and devastate families. I am horrified that CMS is considering this change.
Banas, Tarri	Date: 08/21/2026 Comment: Something as simple as "Stem Cell Transplant” should remain available to all Multiple Myeloma patients as it is a longstanding and more importantly, effective treatment for this incurable cancer. The doctor knows what is best for each patient and every patient should have all options available to them.
Anticev, Elissa	Date: 08/21/2026 Comment: "Stem Cell Transplant should remain available to all Multiple Myeloma patients as it is a longstanding and more importantly, effective treatment for this incurable cancer irregardless of age and insurance.”
Burnham-Cupples, Renee	Date: 08/21/2026 Comment: I am strongly opposed to the proposed changes that would limit coverage for stem cell transplantation in Medicare patients with Stage I Multiple Myeloma. ?? Patients with ISS Stage I Multiple Myeloma deserve access to ALL appropriate treatment options when their hematology/oncology care team recommends them. For many years, transplantation has been an important treatment option for eligible Multiple Myeloma patients. Taking this option away based solely on disease stage could prevent patients from receiving the treatment their doctors believe gives them the best chance for long-term disease control. ?? Medicare coverage decisions can also influence private insurance policies, making this issue important not only for Medicare beneficiaries, but potentially for many other patients as well. Less I am strongly opposed to the proposed changes that would limit coverage for stem cell transplantation in Medicare patients with Stage I Multiple Myeloma. ?? Patients with ISS Stage I Multiple Myeloma deserve access to ALL appropriate treatment options when their hematology/oncology care team recommends them. For many years, transplantation has been an important treatment option for eligible Multiple Myeloma patients. Taking this option away based solely on disease stage could prevent More
Morbitzer, Laurie	Date: 08/21/2026 Comment: Until a person has multiple Myeloma they wouldn't understand that it's better to do everything possible to kill the beast at an early stage vs a later stage. Everyone is wanting to save money but in the long run it's going to cost more money if you wait till it gets worse. Treatments alone are incredibly expensive.
McCarthy, Philip	Title: Professor of Oncology and Internal Medicine Organization: Roswell Park Comprehensive Cancer Center Date: 08/21/2026 Comment: I wish to submit my comments regarding the coverage for Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (MM). The staging system proposed: International Staging System (ISS) is not suitable for determining transplant eligibility. It estimates risk of disease progression and survival. It should not be used for transplant determination. This is also true for the Revised ISS (R-ISS) and the R2-ISS which are further modifications of the ISS. Transplant eligibility is based on disease burden, complications of disease, frailty and other patient characteristics. Less I wish to submit my comments regarding the coverage for Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (MM). The staging system proposed: International Staging System (ISS) is not suitable for determining transplant eligibility. It estimates risk of disease progression and survival. It should not be used for transplant determination. This is also true for the Revised ISS (R-ISS) and the R2-ISS which are further modifications of the ISS. Transplant eligibility is based More
Phelan, Michelle	Date: 08/21/2026 Comment: I am against the proposed changes that has issued a proposed memo stating that transplantation will no longer be covered in Stage I Multiple myeloma patients. A Medicare beneficiary with Multiple Myeloma ISS Stage I disease should have access to pursue a transplant if their care team recommends it. Limiting medical treatments that have been proven highly effective for many years as a first line treatment will cost lives. Thank you for your consideration.
Taylor, Sharon	Title: Mrs Date: 08/21/2026 Comment: No Multiple Myeloma patient should have to wait for a SCT (Stem Cell Transplant) until completing more than one round of other treatment. [PHI Redacted]
Love, Kim	Date: 08/21/2026 Comment: [PHI Redacted] living proof that Stage I patients can benefit from having access to this treatment option. Please do not take that choice away from future patients. The decision about transplant should be made by the patient and their medical team based on the individual—not simply on a stage number. Every myeloma patient deserves access to the treatment options that may give them more time, more hope, and a chance at a longer life.
Jones, Michelle	Date: 08/21/2026 Comment: I am against the proposed changes that has issued a proposed memo stating that transplantation will no longer be covered in Stage I Multiple myeloma patients. A Medicare beneficiary with Multiple Myeloma ISS Stage I disease should have access to pursue a transplant if their care team recommends it. Limiting medical treatments that have been proven highly effective for many years as a first line treatment will cost lives.. My [PHI Redacted] is ISS Stage II and currently in a very good partial response (VGPR) after his stem cell transplant. His doctor did not recognize the signs & lab results 5 years ago when he was Stage I. We have no doubt that if his cancer had been caught early he would be is a complete response (complete remission) after transplant. If CMS approves this proposal similar patients would not have the option of better results. Thank you for your consideration. Less I am against the proposed changes that has issued a proposed memo stating that transplantation will no longer be covered in Stage I Multiple myeloma patients. A Medicare beneficiary with Multiple Myeloma ISS Stage I disease should have access to pursue a transplant if their care team recommends it. Limiting medical treatments that have been proven highly effective for many years as a first line treatment will cost lives.. My [PHI Redacted] is ISS Stage II More
Martin, Kevin	Date: 08/21/2026 Comment: SCT has saved many lives. It needs to stay approved for 1st line funding.
Hughes, Rhonda	Date: 08/21/2026 Comment: Limiting a treatment based on damage level seems counterproductive. Stem Cell Transplants still are the standard treatment for those seeking long-term cancer management; and many find it a great success. It enables them to have much less maintenance than many other treatments. The decision to pursue an SCT needs to be left to those whose lives it effects and their medical team.
Burke, Theresa	Title: Pharmacist Organization: Self Date: 08/21/2026 Comment: This is a bad idea. CMS has no business limiting long practice treatments that have proven highly effective as a first time treatment. This will cost lives! I am against the proposed changes. Ms. Theresa Burke, RPh.
Teel, Jean	Title: Mrs Date: 08/21/2026 Comment: Please do NOT limit availability to successful treatment for Multiple Myeloma patients, no matter at what stage they are disgnosed. Such treatment has been proven successful! It saves lives.
Jones, MJ	Date: 08/21/2026 Comment: I strongly urge there be no restrictions on when a patient may receive SCT or Car-T. This should be a decision of the doctor and patient, working together. In no way should government or insurance companies determine what is best for an individual.
Story, Tamara	Date: 08/21/2026 Comment: [PHI Redacted] I know that it is important for treatment to begin before this disease has destroyed too much bone marrow. Waiting to give SCT means that the disease can attack kidneys, bones, etc. this causes more pain and complications that require long term aggressive treatment. Please let doctors and patients decide who and when SCT is needed.
Amy Buckert, Amy Buckert	Date: 08/21/2026 Comment: This is a potentially life-threatening decision for people without skin in the game to be making. Transplants are a huge decision for doctors and patients to make. Multiple myeloma is incurable, and we need every possible option open to us to continue living with this disease. Transplants have been proven to provide the greatest chance of a deep remission for this disease; a disease in which subsequent remissions are shorter each time. Please do not make this policy change. It will adversely effect so many people who need this life saving treatment. Leave this decision up to the doctors and patients. Less This is a potentially life-threatening decision for people without skin in the game to be making. Transplants are a huge decision for doctors and patients to make. Multiple myeloma is incurable, and we need every possible option open to us to continue living with this disease. Transplants have been proven to provide the greatest chance of a deep remission for this disease; a disease in which subsequent remissions are shorter each time. Please do not make this policy change. It will adversely More
Nicholson, Emily	Date: 08/21/2026 Comment: Stem Cell Transplant should remain available to all Multiple Myeloma patients as it is a longstanding and more importantly, effective treatment for this incurable cancer!
Mascorro, Marcia	Date: 08/21/2026 Comment: The stem cell transplant has proven to be one of the most effective medical treatments to extend the life, offer quality of life and even save the life of multiple myeloma patients. [PHI Redacted] Multiple myeloma patients become sick in ways that other cancer patients do not. They suffer from severe bone pain, anemia, severe lethargy and a host of other painful and debilitating conditions. To force a multiple myeloma patient to become sicker before they are allowed the best available treatment is medically counterintuitive and inhumane. Add to the above scenario the fact that labeling multiple myeloma by stages isn’t even a well developed approach to diagnosing, and you really have a problem. This concept must be shelved. Stem cell transplants must be made available to Medicare patients with multiple myeloma, regardless of “stage“. Less The stem cell transplant has proven to be one of the most effective medical treatments to extend the life, offer quality of life and even save the life of multiple myeloma patients. [PHI Redacted] Multiple myeloma patients become sick in ways that other cancer patients do not. They suffer from severe bone pain, anemia, severe lethargy and a host of other painful and debilitating conditions. To force a multiple myeloma patient to become sicker before they are allowed the best More
Allmand, Kay	Date: 08/21/2026 Comment: Please reconsider the proposed change of disallowing Stem Cell Transplants for Stage I Multiple Myeloma patients. This treatment is a long-standing & proven treatment for extending MM patient’s lives when administered early. It is critical that the this treatment be available for all stages of Multiple Myeloma.
Conner, Renee	Title: Patient Date: 08/21/2026 Comment: No treatment option should be taken away from a person with an incurable disease. Whether or not they choose the SCT route is their decision.
McDanal, Beth	Organization: N/A Date: 08/21/2026 Comment: In my opinion, doctors and patients should be the ones deciding on appropriate treatments, and the timelines at which they are given. MM is not a one size fits all cancer, and shouldn’t be treated as such. ASCT works well for providing a long remission for some, and not for others. The focus should be on research and approval of treatments that have proven to be effective as a potential lifesaving cure for all blood cancers.
Gerber, Diane	Organization: Multiple Myeloma Warrior Member Date: 08/21/2026 Comment: The goal of initial therapy is to achieve the deepest remission possible. SCT has generally shown to provide a patient with a longer progression-free survival. There should be no policy that would restrict access to SCT for patients with Stage 1 multiple myeloma.
syverson, Victoria	Date: 08/21/2026 Comment: Why not take someone at stage 1 and put them into remission for 10-20 years vs waiting for the cancer to progress? With stage 2 and 3 you have now introduced kidney issues potentially dialysis, more bone lesions that lead to a ton of orthopedic issues. Ongoing kidney and orthopedic issues lead to much higher costs and lower quality of life.
Henderson, Deborah	Date: 08/21/2026 Comment: I highly oppose restricting Stem Cell Transplants to Stage 1 Multiple Myeloma patients. This treatment should be available to anyone in any stage of this incurable disease. This decision would restrict treatment that could possibly extend a person’s life. Please do not do this.
Jefferson, Michele	Date: 08/21/2026 Comment: I feel stem cell transplants should be available for all Multiple Myeloma patients, regardless of stage. [PHI Redacted] stage 1 and was fortunate to have a stem cell transplant and remain in MRD- response three years later. Thankfully, this was covered by Medicare.
Langhorne, Dorothy	Date: 08/21/2026 Comment: Stem Cell Transplant should remain available to all Multiple Myeloma patients as it is a longstanding and more importantly, effective treatment for this incurable cancer. If a Multiple Myeloma patient can achieve remission earlier in treatment, then their quality of life can be substantially improved. Please allow all MM patients to access treatment at all stages of this incurable cancer.
Daw, Jessie	Date: 08/21/2026 Comment: Autologous stem cell transplant should remain available to all eligible multiple myeloma patients regardless of ISS stage because transplant eligibility should be based on individual patient fitness and age rather than staging criteria alone. The general consensus among myeloma specialists is that eligible patients should undergo autologous transplant at some point in their treatment spectrum, preferably earlier rather than later in the disease course, as transplant remains the standard of care that can provide deep responses and longer remissions. Medicare/Medicaid should maintain coverage decisions based on comprehensive medical evaluation by qualified physicians rather than implementing arbitrary staging restrictions that don't reflect the individualized nature of myeloma treatment. Less Autologous stem cell transplant should remain available to all eligible multiple myeloma patients regardless of ISS stage because transplant eligibility should be based on individual patient fitness and age rather than staging criteria alone. The general consensus among myeloma specialists is that eligible patients should undergo autologous transplant at some point in their treatment spectrum, preferably earlier rather than later in the disease course, as transplant remains the standard of More
DELL, SHARON	Date: 08/21/2026 Comment: No proven treatment for cancer should be made unavailable. While it is true that newer treatments are surfacing, stem cell transplant is still a proven backbone treatment. It may become obsolete in the future, but we are not there yet. The earlier cancer is treated the better. Some people have a long remission from stem cell transplant and can continue for years with only maintenance treatment or no treatment at all. No one is more aware of the cost of cancer treatment than the patient and very few can afford it without help. Please also consider leaving the out of pocket limits on Part D and extending it pass 2027. Please focus on why more and more people in the US are getting cancer rather than limiting their care. Thank you Less No proven treatment for cancer should be made unavailable. While it is true that newer treatments are surfacing, stem cell transplant is still a proven backbone treatment. It may become obsolete in the future, but we are not there yet. The earlier cancer is treated the better. Some people have a long remission from stem cell transplant and can continue for years with only maintenance treatment or no treatment at all. No one is more aware of the cost of cancer treatment than the patient and More
Propes, David	Date: 08/21/2026 Comment: Do not restrict Stage 1 patients from stem cell transplants. [PHI Redacted]
Alexander, Teri	Date: 08/21/2026 Comment: Eligibility for an ASCT is vital for ISS Stage I patients. MM is not a one size fits all disease. Early diagnosis and transplant has extended so many lives, taking that away from just one person is a great injustice to human lives. Let the doctors decide what is best for their patients.
Johnson, Carolyn	Date: 08/21/2026 Comment: Studies have proven time and time again the benefits of ASCTs in multiple myeloma, including in stage 1 disease. An ASCT can greatly improve the quality of life for myeloma patients, especially those who do not respond well to treatments or who have high risk disease. As with all treatments covered by Medicare/medicade, if the science supports the treatment, and the doctor finds that it is medically necessary, the choice to have the treatment should be left to the patient, not the government. DO NOT deny stem cell transplants for stage 1 myeloma patients . Less Studies have proven time and time again the benefits of ASCTs in multiple myeloma, including in stage 1 disease. An ASCT can greatly improve the quality of life for myeloma patients, especially those who do not respond well to treatments or who have high risk disease. As with all treatments covered by Medicare/medicade, if the science supports the treatment, and the doctor finds that it is medically necessary, the choice to have the treatment should be left to the patient, not the government. More
Jaclson, Tannda	Title: MM Organization: UAMS Date: 08/21/2026 Comment: Please do not remove SCT from Multiple Mylenoma therapy!!! Multiple Mylenoma is incurable!!! SCT helps to control this terrible disease!!!!!!!!
Sandler, Doris	Title: Ms Date: 08/21/2026 Comment: It is critical for Stem Cell Transplants are available for patients as their doctors deem necessary to treat life-altering diagnosis. Government should in no way be involved in decision making as pertains life saving treatments.
Young, Katy	Date: 08/21/2026 Comment: I strongly oppose the proposed CMS change that would limit Medicare coverage for autologous stem cell transplantation in multiple myeloma to patients with ISS Stage II or III disease. Autologous stem cell transplantation has been a long-established and highly effective treatment for eligible patients with multiple myeloma. Whether a patient should undergo transplant is an individualized medical decision that belongs between the patient and their myeloma specialist. ISS stage should not be used by CMS to take that option away. Patients with Stage I disease should not be penalized for being diagnosed at an earlier stage. If a patient and their physician determine that transplant is the appropriate treatment based on the patient’s individual disease characteristics, risk factors, health, and the available medical evidence, Medicare should provide coverage. Multiple myeloma is a serious and still-incurable blood cancer. Restricting access to an established treatment option could have profound and potentially life-threatening consequences for patients. CMS should be expanding access to appropriate cancer care—not creating a barrier that prevents physicians and patients from choosing a proven treatment. I urge CMS to remove the proposed ISS Stage II–III restriction and preserve Medicare coverage for autologous stem cell transplantation for all medically appropriate, transplant-eligible patients with multiple myeloma, regardless of ISS stage. Less I strongly oppose the proposed CMS change that would limit Medicare coverage for autologous stem cell transplantation in multiple myeloma to patients with ISS Stage II or III disease. Autologous stem cell transplantation has been a long-established and highly effective treatment for eligible patients with multiple myeloma. Whether a patient should undergo transplant is an individualized medical decision that belongs between the patient and their myeloma specialist. ISS stage should More
Rubinstein, Samuel	Title: Clinical Associate Professor of Medicine Organization: UNC-Chapel Hill Date: 08/21/2026 Comment: I have significant concerns about imperiling the ability of patients with ISS-1 multiple myeloma to undergo autologous stem cell transplantation under Medicare coverage. The ISS is an antiquated staging system which does not account for many factors that are now widely accepted to correlate with therapeutic resistance of myeloma. I manage many patients who have unambiguously high risk multiple myeloma (for which autologous stem cell transplantation results in improved overall survival) who technically would be classified under the ISS as having stage 1 disease. This policy as implemented would risk denying patients a lifesaving intervention. Less I have significant concerns about imperiling the ability of patients with ISS-1 multiple myeloma to undergo autologous stem cell transplantation under Medicare coverage. The ISS is an antiquated staging system which does not account for many factors that are now widely accepted to correlate with therapeutic resistance of myeloma. I manage many patients who have unambiguously high risk multiple myeloma (for which autologous stem cell transplantation results in improved overall survival) who More
Hartley Gillispie, Sue	Date: 08/21/2026 Comment: I urge the CMS not to pursue ISS staging requirements for ASCT. Multiple Myeloma is a highly individualized cancer with early detection and treatment providing the best outcomes for patients. Physicians are already delaying ASCT for some patients and reserving it for the most aggressive forms or late stages of the disease (including aggressive stage 1 cases) so this proposal seems like it must be driven by health insurance companies and lobbyists. Physicians need to maintain control of treatment options for their patients. Less I urge the CMS not to pursue ISS staging requirements for ASCT. Multiple Myeloma is a highly individualized cancer with early detection and treatment providing the best outcomes for patients. Physicians are already delaying ASCT for some patients and reserving it for the most aggressive forms or late stages of the disease (including aggressive stage 1 cases) so this proposal seems like it must be driven by health insurance companies and lobbyists. Physicians need to maintain control of More
Anderson, Larry	Title: Professor Organization: UT Southwestern Medical Center Date: 08/21/2026 Comment: Dear CMS, Please reconsider the proposed policy and do NOT limit stem cell transplant to higher stage patients. Stage 1 patients (using DS or ISS or R-ISS) often have very active and symptomatic disease, and stage 1 it is NOT synonymous with smoldering myeloma. Stage 1 patients should be allowed to have standard therapy with stem cell transplant to improve their chances of a durable remission.
Niederer, Jodi	Date: 08/21/2026 Comment: Stem Cell Transplants have saved many lives of those individuals with Multiple Myeloma regardless the Stage 1, 2 or 3. I believe it is discriminatory to exclude individuals with Stage 1 multiple myeloma to a treatment that is life saving. Please reconsider this action so that access is available to ALL diagnosed with multiple myeloma regardless the stage.
Al Hadidi, Samer	Title: Associate Professor Organization: UT Southwestern Medical Center Date: 08/21/2026 Comment: I urge CMS to reconsider the proposed ISS staging requirement for ASCT coverage in multiple myeloma. Long-term follow-up data—the longest of any phase 3 trial in myeloma—demonstrates that ISS stage I patients treated with transplant achieve durable, meaningful survival. Among 1,202 patients across three Total Therapy trials followed for 15-25 years, 55% were ISS stage I disease; these patients experienced survival rates approaching those of higher stages when given access to transplant. More recent data from our Total Therapy IV trial shows 13-year median overall survival with 61% surviving 10 years—outcomes achieved through transplant-based therapy offered to all appropriately selected patients regardless of stage. As a physician, my role is to discuss treatment options with patients based on clinical evidence—not to defend coverage decisions to insurance companies. Staging is a prognostic tool, not a clinical decision rule. The proposed policy contradicts evidence-based, patient-centered care. I recommend CMS remove staging requirements and trust clinicians to make appropriate recommendations for individual patients based on performance status, biology, and shared decision-making. Less I urge CMS to reconsider the proposed ISS staging requirement for ASCT coverage in multiple myeloma. Long-term follow-up data—the longest of any phase 3 trial in myeloma—demonstrates that ISS stage I patients treated with transplant achieve durable, meaningful survival. Among 1,202 patients across three Total Therapy trials followed for 15-25 years, 55% were ISS stage I disease; these patients experienced survival rates approaching those of higher stages when given access to More
Ramos, Mariline	Organization: RN Date: 08/21/2026 Comment: [PHI Redacted] who suffers with chronic pain when walking and generalized pain daily this is not a good idea many people will suffer greatly without the SCT.
Morellk, Frank	Organization: None Date: 08/21/2026 Comment: This potential decision appears to not consider the multi varied issues myeloma patients face at every stage of their disease To limit stem cell transplants to specific classifications of risk factors suggests that the disease is stagnant and does not evolve into different levels of complexities and treatments over time. A myeloma patients initial diagnosis is not etched in stone, and remains in the same stage for the balance of their treatment and life. There are mutation factors, co morbidities, reaction to treatments that are all essential considerations that establish one fact; early intervention/treatment presents the best opportunity for optimal outcome. Basically this proposal establishes that a myeloma patients condition should worsen before one of the most effective standard of care options is considered. Once this proposal is carefully thought through, taking all patient factors into account, and the unpredictability and evolving nature of multiple myeloma, hopefully this will be an afterthought, and not a reality. [PHI Redacted] Less This potential decision appears to not consider the multi varied issues myeloma patients face at every stage of their disease To limit stem cell transplants to specific classifications of risk factors suggests that the disease is stagnant and does not evolve into different levels of complexities and treatments over time. A myeloma patients initial diagnosis is not etched in stone, and remains in the same stage for the balance of their treatment and life. There are mutation factors, co More
Blau, Tony	Organization: All4Cure Date: 08/21/2026 Comment: I am professor emeritus at the University of Washington and founder and CEO of All4Cure, a platform for patients, clinicians and researchers, currently focused on multiple myeloma. All4Cure is designed to learn from each patient’s experience, identify patients eligible for clinical trials, and empower general oncologists to deliver expert level care. After carefully reviewing the complete journeys of >1200 MM patients, I believe that the proposed rule change would inevitably deny patients and their doctors from access to an important treatment option. [PHI Redacted] trying to make the right treatment decisions for oneself is hard enough without the additional burden of contending with well intended but harmful regulations. Less I am professor emeritus at the University of Washington and founder and CEO of All4Cure, a platform for patients, clinicians and researchers, currently focused on multiple myeloma. All4Cure is designed to learn from each patient’s experience, identify patients eligible for clinical trials, and empower general oncologists to deliver expert level care. After carefully reviewing the complete journeys of >1200 MM patients, I believe that the proposed rule change would inevitably deny patients More
Mitchell, K	Title: MM Caregiver Date: 08/21/2026 Comment: Taking way transplant for those in need is a huge mistake! You will cost lives if this option is taken away.
Clem, Catherine	Date: 08/21/2026 Comment: Please do not mess with this. This is a treatment that has been proven to word and have long term success. [PHI Redacted] had this treatment in 2024 & know it has been successful thus far.
Harris, Cindy	Date: 08/21/2026 Comment: Many people with stage 1 multiple myeloma have had amazing results and lived , long productive lives, sometimes with very little , if any, additional additional and costly lines of treatment. I’m against this .
Kahn, Peter	Date: 08/21/2026 Comment: This is a long-standing effective treatment. The fact that you are going to try to take this away from people is a huge mistake and probably driven by ideological reasons as opposed to scientific ones. It is essential that our government use reason not ideology. This is not the Soviet Union. We cannot allow this to happen.
Burgess, Robert	Date: 08/21/2026 Comment: Bad idea. Stem Cell transplant should remain available
Stiles, Tammy	Date: 08/21/2026 Comment: This is a really bad idea and will cost lives! A proven treatment should not be changed.
Richter, Kim	Date: 08/21/2026 Comment: [PHI Redacted] had a SCT with Stage 1, this pasted Nov. It’s an important part of having MM and anyone should qualify for it if it’s something they need. It’s not easy living with MM and now you want to take an option. You people should be ashamed of yourself!
Graham, Denise	Date: 08/21/2026 Comment: Not a good idea. This could cost lives
Strickland, Brian	Date: 08/21/2026 Comment: Stem Cell Transplant should remain available to all Multiple Myeloma patients as it is a longstanding and more importantly, effective treatment for this incurable cancer. [PHI Redacted] It’s critical that this remains available to everyone.
Fuller, Lynell	Date: 08/21/2026 Comment: [PHI Redacted] I know that treating MM aggressive g at first diagnosed onset is the best path to a longer more productive lifestyle. When waiting until the disease progresses to perform know effective treatments the efficacy starts declining. This is a tried and true and very effective treatment and to deny Medicare patients the right to choose is kin to sentencing them to an early grave. Each treatment extends life and with more treatments being approved it is an important tool in the process of extending life to MM survivors. It is SOC and denying this choice could ultimately make treatments more expensive and the added health issues lowering the quality of life for those of us living with this disease. Less [PHI Redacted] I know that treating MM aggressive g at first diagnosed onset is the best path to a longer more productive lifestyle. When waiting until the disease progresses to perform know effective treatments the efficacy starts declining. This is a tried and true and very effective treatment and to deny Medicare patients the right to choose is kin to sentencing them to an early grave. Each treatment extends life and with more treatments being approved it is an More
Jones, Suz	Date: 08/21/2026 Comment: As a family member of a current multiple myeloma patient in recovery following a stem cell transplant. I encourage Medicare to reconsider denying patients the early intervention that has proven successful in the treatment of multiple myeloma. Thank you for your consideration.
McAdams, Barbara	Date: 08/21/2026 Comment: I would like to express my concern over the possibility of limiting SCT in any way. Having an incurable cancer, like Multiple Myeloma, can cause fear and many challenges for patients. Especially those that are caught early or newly diagnosed. It is terrifying news to receive from your physician. What gives us all hope is that there are options for treatment. Thank you.
Jones, Ruth	Date: 08/21/2026 Comment: [PHI Redacted] is a stage II myeloma patient currently in a very good partial response after a stem cell transplant. He was diagnosed too late by his doctors. If the cancer would have been caught 5 years ago when his labs indicated he was sick he would have been stage 1 and with the current treatments available he would be in complete remission. How dare you - the government, decide who can get access to life saving treatments. There is enough money to fund medical research, life saving medical procedures.. tax the ultra wealthy nowwww!! Less [PHI Redacted] is a stage II myeloma patient currently in a very good partial response after a stem cell transplant. He was diagnosed too late by his doctors. If the cancer would have been caught 5 years ago when his labs indicated he was sick he would have been stage 1 and with the current treatments available he would be in complete remission. How dare you - the government, decide who can get access to life saving treatments. There is enough money to fund medical More
Harmon, Diana	Date: 08/21/2026 Comment: An Autologous Stem Cell Transplant must remain available to all patients regardless of staging! To deny patients this option early in the disease is unethical. Every patient deserves the best chance at a long and deep remission.
Ho, Diep-Thuy	Date: 08/21/2026 Comment: Medical treatment decisions should be left to the treating provider and the patient to make together. A long standing proven treatment option should not be excluded from Stage I patients, nor should it be made harder to obtain through adding unnecessary hurdles.
Herzog, Laralee	Date: 08/21/2026 Comment: This decision will cause the death of many patients needing a stem cell transplant. This cannot happen.
Boese, Carol	Title: Ms Date: 08/21/2026 Comment: [PHI Redacted] eligibility for an ASCT is vital for ISS Stage I patients. MM is not a one size fits all disease. Earlier transplants have shown to extend lives.
Goodyear, Allison	Date: 08/21/2026 Comment: I feel this is wrong. A patient’s and oncologist’s choice should not be determined by you.
Marquis, Linda	Date: 08/21/2026 Comment: Multiple Myeloma patient treatment decision including AuSCT should be an option without staging criteria
Harnas, Erin	Date: 08/21/2026 Comment: Stem Cell Transplant should remain available to all Multiple Myeloma patients because it is an effective treatment for this incurable cancer.
Brunetti, Linda	Title: Mrs Date: 08/21/2026 Comment: I believe that Stem Cell Transplant should remain available to all Multiple Myeloma patients as it is a longstanding, and more importantly, effective treatment for this incurable cancer.
Atwell, Sherry	Date: 08/21/2026 Comment: [PHI Redacted] This decision is to be msde by qualified doctors/specialists in this field of medicine!
Feldt, Christopher	Title: Coverage For Multiple Myeloma Date: 08/21/2026 Comment: I believe the standard of care should be up to the doctor and his patient. Insurance companies/government agencies should never be allowed to make the decision for the patient. Thank you.
Benson, Paula	Date: 08/21/2026 Comment: [PHI Redacted] I have seen how devastating this disease is, not only to the patient, but to the families and friends. SCT is a very powerful tool in our toolbox to fight this disease. I respectfully request that this important, possibly life saving tool not be removed.
Kopchinski, Kimberly	Date: 08/21/2026 Comment: Staging should not be used to determine eligibility/reimbursement for autologous stem cell transplantation for multiple myeloma. Lives will be lost Not having this available to all MM patients.
Carter, Cheryl	Date: 08/20/2026 Comment: If this was your loved one newly diagnosed with MM you would think different. Early treatment is essential for a positive outcome. Seniors have paid into the system and deserve the best care possible. As usual anything in the governments hands suck!
Minniear, Rosemary	Date: 08/20/2026 Comment: ASCT should continue to be available for patients with stage I Multiple Myeloma in order to allow them the best outcome possible. If treated aggressively early, the prognosis is so much better for patients. [PHI Redacted] I know how important this is.
Flanagan, Anne	Date: 08/20/2026 Comment: It is wrong to limit asct to stage 1 multiple Myeloma patients. This group of people have added so much to research efforts. I hope that you will reconsider this.
Walton-Turner, Karla	Date: 08/20/2026 Comment: [PHI Redacted] I'm very concerned that Stage 1 patients may have stem cell transplants restricted. It's highly effective treatment that extends remissions and saves lives.
Tackman, Kurt	Date: 08/20/2026 Comment: I believe that this treatment with proven effectiveness should remain available to individuals with any level of diagnosed disease.
Hutain, Wendy	Date: 08/20/2026 Comment: [PHI Redacted] I feel very strongly that a person newly diagnosed with multiple myeloma, any stage, should be able to choose to have, a possibly, life saving stem cell transplant. This choice should not be dictated by medicare or insurance. Having the best treatment available upfront so very important to that person's longevity and quality of life. Think of how you would want to be treated or your grandparent or mother or sister or even your child. They would need and you would want them to have the best available care upfront. With multiple myeloma, it's so very important! Do not do this! Please. Less [PHI Redacted] I feel very strongly that a person newly diagnosed with multiple myeloma, any stage, should be able to choose to have, a possibly, life saving stem cell transplant. This choice should not be dictated by medicare or insurance. Having the best treatment available upfront so very important to that person's longevity and quality of life. Think of how you would want to be treated or your grandparent or mother or sister or even your child. They would need and you More
Cottrell, Loretta	Date: 08/20/2026 Comment: As someone experienced with multiple myeloma and its impact on patient lives, I do not agree with the removal of ASCTs from the list of covered options for stage 1 patients. Research has shown that stage 1 patients stand to benefit significantly by achieving long term remission through ASCT. Further, so much about multiple myeloma is still unknown even with the advances of the last few years. I believe removing ASCTs from stage 1 options would be detrimental to the lives of those patients.
Strickler, apewatcher@hotmail.com	Date: 08/20/2026 Comment: Seriously, what are you doing here? From my understanding [PHI Redacted], there is no medically valid reason to do this. A Stem Cell Transplant at Stage I is effective and likely has the best outcome, in part because the patient at that stage is best able to tolerate the treatment. This will likely kill people, and why? Because you want to save money at the expense of the American citizens you’re supposed to care for? This is a bad idea. Withdraw it.
O, V	Date: 08/20/2026 Comment: How can patients who have a decent grasp of wellness be excluded from this important treatment? It is inhumane to deny coverage for this effective therapy for these stages. I cannot imagine why we would want to fail these blood cancer patients and lengthen their suffering when we have a useful, important tool in our very hands. What a cruel decision. Please reconsider covering transplant for the patients who need it.
Tounsley, Cipi	Date: 08/20/2026 Comment: I firmly believe that any and all treatments should remain available to any level of patients. As [PHI Redacted], having to choose between a life saving/prolonging procedure and not being covered for it is horrible. Please continue to cover stage I patients for autologous transplant and any other treatment that a patient could benefit from.
Kennedy, Diane	Title: Care Partner Organization: Independent Date: 08/20/2026 Comment: As a care partner to [PHI Redacted] who is a myeloma patient and [PHI Redacted] who has MGUS —- this is NOT based on science —- something we have always prided ourselves with in the United States of America. A patient's labs, imaging, and disease should determine whether an ASCT is beneficial. The staging in multiple myeloma has NEVER been a determining factor regarding disease progression or the likelihood of relapse. TRUST ME when I say —- no one signs up for an ASCT for fun!! This should be a SERIOUS decision between a patient and their care team, not decided arbitrarily by the government. Less As a care partner to [PHI Redacted] who is a myeloma patient and [PHI Redacted] who has MGUS —- this is NOT based on science —- something we have always prided ourselves with in the United States of America. A patient's labs, imaging, and disease should determine whether an ASCT is beneficial. The staging in multiple myeloma has NEVER been a determining factor regarding disease progression or the likelihood of relapse. TRUST ME when I say —- More
Wilcox, Craig	Date: 08/20/2026 Comment: I am a licensed Medicare insurance agent,[PHI Redacted] I know that if CMS stops covering transplants for people with Medicare, commercial payers will follow. Autologous transplant can benefit people at any stage of myeloma and it is important to hit the disease with maximally aggressive treatment from the start for the most durable responses. Other treatments will eventually replace SCT as they become approved for earlier use, but until then I hope CMS will reconsider its proposed policy change. Less I am a licensed Medicare insurance agent,[PHI Redacted] I know that if CMS stops covering transplants for people with Medicare, commercial payers will follow. Autologous transplant can benefit people at any stage of myeloma and it is important to hit the disease with maximally aggressive treatment from the start for the most durable responses. Other treatments will eventually replace SCT as they become approved for earlier use, but until then I hope CMS will reconsider its More
Burgans, Nancy	Date: 08/20/2026 Comment: Not a good idea
Abke, Sue	Date: 08/20/2026 Comment: I know many people who have survived years with Multiple Myeloma that had a stem cell transplant at Stage 1 God Bless and thanks Sue
Mellenthin, Dawn	Date: 08/20/2026 Comment: Cancer patients of any stage should have access to a stem cell transplant, if that’s what their doctor and them feel it is their best chance of survival. This is a decision that shouldn’t be made by anyone other than doctor and patient.
Elsasser, Joan	Date: 08/20/2026 Comment: This is not a good idea. I am against the proposed changes. CMS has no business limiting long practiced treatments that have been proven highly effective as a first line treatment. Tell them it will cost lives and you are against the proposed changes.
Teitelman, Judy	Date: 08/20/2026 Comment: Stem Cell Transplant should remain available to ALL Multiple Myeloma patients as it is a longstanding and more importantly, effective, treatment for this incurable cancer.
Ramaley, Bridgette	Date: 08/20/2026 Comment: This proposed change seems counterintuitive to the science. As the [PHI Redacted] of a person getting a SCT this fall, I can say with certainty that this is the best option as a first line treatment. To my understanding this is standard practice at this time and there is not currently scientific justification to change this practice. I think this proposed change will cost lives. This cancer is one where time is the best thing you can hope for. It’s not curable. So give people the best treatment that gives them the time. SCT as a first line option is the thing that gives the most time. Less This proposed change seems counterintuitive to the science. As the [PHI Redacted] of a person getting a SCT this fall, I can say with certainty that this is the best option as a first line treatment. To my understanding this is standard practice at this time and there is not currently scientific justification to change this practice. I think this proposed change will cost lives. This cancer is one where time is the best thing you can hope for. It’s not curable. So give More
Holt, Debbie	Title: retired RN Date: 08/20/2026 Comment: MM is a beast of a disease. The sooner it is caught and treated the better. I think stage 1 should be able to benefit from ASCT. Thank you
Dickinson, Nancy	Date: 08/20/2026 Comment: All patients should be able to have transplant benefits regards of their ISS staging ( I, II, III) There is data proving it’s beneficial for all stages.
Trueman, Bonnie	Date: 08/20/2026 Comment: [PHI Redacted] I don't agree with excluding patients with stage 1 Multiple Myeloma from eligibility for autologous transplant. Patients need more treatment options earlier with this cancer when our immune system is stronger and our overall health is better. Please reconsider. Thank you.
Leach, Lori	Date: 08/20/2026 Comment: This a bad idea and CMS has no business limiting long practiced treatments that have been proven highly effective as a first line treatment. It will cost lives and I, [PHI Redacted], am against the proposed changes.
Myrick, Mindy	Date: 08/20/2026 Comment: ASCT for stage 1 Multiple Myeloma patients should be covered. Studies have shown that ASCT is an important option for patients at all stages.
Stephenson, Alan	Title: Stem cell transplants for Multiple Myeloma Organization: Multiple Myeloma Warrior Community Date: 08/20/2026 Comment: As a [PHI Redacted], patient advocate, and founder of the 12,000 member multiple myeloma warrior community Facebook group., I am very concerned with the proposed changes regarding stem cell transplants being available as a first line treatment. [PHI Redacted] CMS has no business limiting patient treatment options that have a long history of being effective. This proposed change will cost lives.
Thibeault, Terence	Date: 08/20/2026 Comment: Stem Cell Transplant (SCT) is a well established medical treatment that should be available to all patients who are diagnosed with multiple myeloma regardless of which stage they are diagnosed with (1,2, or 3). It has long been established as the standard of care for Myeloma patients. Myeloma is very treatable condition, however denying access to SCT to a stage 1 patient can result in inadequate treatment and have devastating effects to the patient.
Chmielewski, Cindy	Organization: HealthTree Foundation Date: 08/20/2026 Comment: [PHI Redacted] I have serious concerns about excluding patients with Stage I multiple myeloma from Medicare coverage for autologous stem cell transplant (ASCT). Stage I does not mean a patient does not have active, treatment-requiring myeloma. It is a prognostic classification, and patients with Stage I disease may still be appropriate candidates for transplant. Having a more favorable prognosis should not result in having fewer evidence-based treatment options. Coverage decisions should reflect whether a patient has active myeloma and is medically appropriate for ASCT—not their stage alone. Patients and their physicians should be able to make individualized treatment decisions based on the best available evidence, without an arbitrary coverage barrier. Less [PHI Redacted] I have serious concerns about excluding patients with Stage I multiple myeloma from Medicare coverage for autologous stem cell transplant (ASCT). Stage I does not mean a patient does not have active, treatment-requiring myeloma. It is a prognostic classification, and patients with Stage I disease may still be appropriate candidates for transplant. Having a more favorable prognosis should not result in having fewer evidence-based treatment More
Krishnan, Amrita	Title: Professor Hematology/HCT Organization: City of Hope Date: 08/20/2026 Comment: I strongly urge CMS to revise the decision and include patients with ISS Stage I disease under coverage for autologous HCT Multiple randomized trials have demonstrated a benefit to auto HCT over conventional therapy including in patients with Stage 1 disease. Upfront auto HCT offers one of the longest PFS of any therapy and we should not deny such effective therapy to Stage I patients who have been proven to benefit from this therapy.
Richard, Shambavi	Title: Associate Professor of Medicine Organization: Mount Sinai School of Medicine Date: 08/20/2026 Comment: I have serious concerns about excluding patients with ISS stage 1 myeloma from eligibility for CMS coverage for autologous transplant. We have published data showing that myeloma patients of all stages benefit from an autologous transplant, and stage 1 paitents have a higher potential to benefit with possibility of long term remissions from transplant. The Durie Salmon and ISS staging are not interchangeable and all patients with myeloma should have access to this important treatment option.
Cottini, Francesca	Date: 08/20/2026 Comment: As a myeloma physician, I feel strongly that eligibility for ASCT should be based on active multiple myeloma defined by current IMWG SLiM/CRAB criteria rather than on stage-based restrictions. Excluding patients with ISS stage I multiple myeloma from CMS coverage for ASCT is not supported by contemporary evidence or clinical practice. Patients with ISS stage I disease often derive substantial benefit from ASCT, including some of the longest remissions, with many surviving beyond 10 years and potentially representing a curable subset. If staging criteria are retained, coverage should include patients across ISS stages I, II, and III, as treatment decisions depend on multiple clinical factors beyond ISS stage alone. ASCT remains a safe, cost-effective, and highly effective treatment option that should remain accessible to all appropriate myeloma patients. Less As a myeloma physician, I feel strongly that eligibility for ASCT should be based on active multiple myeloma defined by current IMWG SLiM/CRAB criteria rather than on stage-based restrictions. Excluding patients with ISS stage I multiple myeloma from CMS coverage for ASCT is not supported by contemporary evidence or clinical practice. Patients with ISS stage I disease often derive substantial benefit from ASCT, including some of the longest remissions, with many surviving beyond 10 years and More
Pasquini, Marcelo	Title: Professor Organization: Cleveland Clinic, Cleveland, United States Date: 08/20/2026 Comment: This current position will restrict access to patients, and the rationale is not scientific valid nor conform with standard practice worldwide. Recent clinical trials that demonstrate the benefit of upfront transplant over no transplant did not take into account DS staging. Limiting to patients with partial response or better is also a mistake. In the setting of current powerful upfront immunotherapy regimens, patients who have less than a PR can still upgrade their response with high dose melphalan. Lastly limitation based on renal function is unwarranted as the myeloma transplant community is comfortable in safely managing these transplants, and these patients can derive benefit. Less This current position will restrict access to patients, and the rationale is not scientific valid nor conform with standard practice worldwide. Recent clinical trials that demonstrate the benefit of upfront transplant over no transplant did not take into account DS staging. Limiting to patients with partial response or better is also a mistake. In the setting of current powerful upfront immunotherapy regimens, patients who have less than a PR can still upgrade their response with high dose More
Lonial, Sagar	Title: Chair and Professor Dept of Hema and Med Onc Organization: Emory Universirty school of Medicine and Winship Cancer Institute Date: 08/19/2026 Comment: I have serious concerns about excluding patients with ISS stage 1 myeloma from eligibility for CMS coverage for autologous transplant. emerging data suggests that for all mm patients that auto transplant continues to offer benefit (Persus trial update IMS 2026) and for stage 1 patients, they are enriched among the patients with remission >10 years and maybe in a cure fraction of patients. not being able to offer transplant which is much safer than CART, more cost effective, and has the potential for cure to the patients most suited to gain benefit from transplant does not make sense. while the old Durie Salmon stage 1 was not considered symptomatic myeloma, that is not the case with ISS stage 1 which should continue to be allowed access to this important treatment option Less I have serious concerns about excluding patients with ISS stage 1 myeloma from eligibility for CMS coverage for autologous transplant. emerging data suggests that for all mm patients that auto transplant continues to offer benefit (Persus trial update IMS 2026) and for stage 1 patients, they are enriched among the patients with remission >10 years and maybe in a cure fraction of patients. not being able to offer transplant which is much safer than CART, more cost effective, and has the More
Nooka, Ajay	Title: Professor of Hematology and Oncology Organization: Emory University Winship Cancer Institute Date: 08/19/2026 Comment: The pateints with ISS stage I and Durie- Salmon Stage I do benefit from autologous stem cell transplant. By denying the ISS stage I and Durie- Salmon Stage I myeloma patients of an autologous stem cell transplant, CMS will not be allowing for these patients to reach their life expectancy. Here is data from our own insititution where the patients with ISS stage I and Durie- Salmon Stage I (along with other myeloma patients) have lived beyond the 10-year mark, most impact yielded by transplant Joseph NS, Kaufman JL, Dhodapkar MV, Hofmeister CC, Almaula DK, Heffner LT, Gupta VA, Boise LH, Lonial S, Nooka AK. Long-Term Follow-Up Results of Lenalidomide, Bortezomib, and Dexamethasone Induction Therapy and Risk-Adapted Maintenance Approach in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2020 Jun 10;38(17):1928-1937. doi: 10.1200/JCO.19.02515. Epub 2020 Apr 16. Erratum in: J Clin Oncol. 2020 Aug 10;38(23):2702. doi: 10.1200/JCO.20.01986. PMID: 32298201; PMCID: PMC7587409. Less The pateints with ISS stage I and Durie- Salmon Stage I do benefit from autologous stem cell transplant. By denying the ISS stage I and Durie- Salmon Stage I myeloma patients of an autologous stem cell transplant, CMS will not be allowing for these patients to reach their life expectancy. Here is data from our own insititution where the patients with ISS stage I and Durie- Salmon Stage I (along with other myeloma patients) have lived beyond the 10-year mark, most impact yielded by More
Garfall, Alfred	Title: MD Organization: Abramson Cancer Center, University of Pennsylvania Date: 08/17/2026 Comment: I am an Associate Professor of Medicine and Director of the Autologous and Hematopoietic Stem Cell Transplant (AuHCT) program at the Abramson Cancer Center of the University of Pennsylvania. I disagree with the proposed change to the National Coverage Determination that would exclude coverage for patients with ISS stage 1 multiple myeloma. The ostensible rationale for the proposed change is to update the NCD to incorporate newer staging systems such as ISS, as the Durie-Salmon (DS) staging system is seldom used in practice today. The restriction of AuHCT to DS stage 2/3 patients was appropriate since many DS stage 1 patients would today be classified as smoldering rather than active multiple myeloma and thus not be appropriate for intensive therapy such as AuHCT. Stage 1 patients by the ISS, however, do have active multiple myeloma and are appropriate for AuHCT. Indeed, ISS stage 1 patients have been well represented in the major clinical trials that demonstrated the benefit of AuHCT for multiple myeloma, as detailed below. This change, though well-intentioned to update the NCD to incorporate newer staging systems, does not account for the substantial differences in these staging systems and excludes a large portion of patients with active multiple myeloma for whom AuHCT is appropriate and beneficial. The following evidence supports the benefit of AuHCT for ISS stage 1 patients: IFM 2009 showed improved progression-free survival (PFS) with upfront ASCT, including in the prespecified ISS stage I subgroup (Attal et al., N Engl J Med. 2017). DETERMINATION confirmed a substantial PFS benefit with upfront ASCT, again including ISS stage I disease (Richardson et al., N Engl J Med. 2022). EMN02/HO95 demonstrated improved PFS with ASCT versus non-transplant intensification across ISS stages I–III (Cavo et al., Lancet Haematol. 2020), and FORTE likewise supported upfront ASCT across ISS subgroups, including stage I (Gay et al., Lancet Oncol. 2021). Instead of stage-based restrictions, the NCD should instead require that patients have active multiple myeloma according to the current IMWG criteria, the SLiM/CRAB criteria. These criteria require the presence of myeloma-defining organ dysfunction or biomarkers that predict impending organ dysfunction. This requirement would accomplish the objective of the prior Durie-Salmon stage-based restrictions while aligning with contemporary diagnostic categories. Nonetheless, if CMS concludes that a staging reference must remain, the language should cover AuHCT for patients with active multiple myeloma across ISS stages I, II, and III. Thank you for your consideration. Less I am an Associate Professor of Medicine and Director of the Autologous and Hematopoietic Stem Cell Transplant (AuHCT) program at the Abramson Cancer Center of the University of Pennsylvania. I disagree with the proposed change to the National Coverage Determination that would exclude coverage for patients with ISS stage 1 multiple myeloma. The ostensible rationale for the proposed change is to update the NCD to incorporate newer staging systems such as ISS, as the Durie-Salmon (DS) More
Varga, Cindy	Title: Associate Professor Organization: Levine Cancer Institute Date: 08/15/2026 Comment: As a myeloma physician, I feel strongly that all patients with myeloma, regardless of iss stage, should be considered for asct. In fact, it is the iss stage I group that may reap the most benefit from ASCT. The decision to proceed with asct relies on many factors beyond iss staging. Please reconsider
Wilson, Carmen	Title: Physician Assistant Organization: Washington University School of Medicine Date: 08/14/2026 Comment: I am a PA specializing in multiple myeloma, hematopoietic cell transplantation and cellular therapy at Siteman Cancer Center. I strongly support CMS’s reconsideration of National Coverage Determination (NCD) 110.23. However, the proposed revision—adding the International Staging System (ISS) alongside Durie-Salmon stage II/III—preserves the central flaw in the current policy: prognostic stage should not determine Medicare coverage for autologous stem cell transplantation (ASCT). The historical reason for the Durie-Salmon restriction is important. When Durie-Salmon staging was introduced in 1975, smoldering multiple myeloma had not yet been defined. Durie-Salmon stage I therefore included a heterogeneous mixture of patients with active myeloma and patients who today would be classified as having smoldering myeloma. Excluding stage I patients from the early pivotal ASCT trials was reasonable because investigators appropriately sought to avoid exposing patients with asymptomatic disease to high-dose chemotherapy. Those trial eligibility criteria ultimately became embedded in the NCD. That problem has since been solved—not by a newer prognostic staging system, but by modern diagnostic criteria. The International Myeloma Working Group now clearly distinguishes smoldering from active multiple myeloma using SLiM/CRAB criteria. ISS and its revisions serve a different purpose: they estimate prognosis after active myeloma has been diagnosed. An ISS stage I patient with SLiM/CRAB-defined active myeloma is therefore fundamentally different from the heterogeneous Durie-Salmon stage I population that motivated the original restriction. Treating the two staging systems as interchangeable is an apples-to-oranges comparison. Contemporary randomized evidence also demonstrates that ASCT benefit is not confined to higher ISS stages. IFM 2009 showed improved progression-free survival (PFS) with upfront ASCT, including in the prespecified ISS stage I subgroup (Attal et al., N Engl J Med. 2017). DETERMINATION confirmed a substantial PFS benefit with upfront ASCT, again including ISS stage I disease (Richardson et al., N Engl J Med. 2022). EMN02/HO95 demonstrated improved PFS with ASCT versus non-transplant intensification across ISS stages I–III (Cavo et al., Lancet Haematol. 2020), and FORTE likewise supported upfront ASCT across ISS subgroups, including stage I (Gay et al., Lancet Oncol. 2021). These trials provide no evidence basis for denying ASCT coverage solely because a patient with active myeloma has favorable prognostic stage. The proposed policy would therefore create a new and clinically unjustified exclusion: Medicare beneficiaries with unequivocally active, treatment-requiring myeloma could be denied ASCT simply because they have ISS stage I disease. Favorable prognosis is not evidence that transplantation is unnecessary. I urge CMS to eliminate stage-based eligibility requirements rather than substitute ISS for Durie-Salmon. Coverage should be based on (1) active multiple myeloma requiring therapy by contemporary diagnostic criteria, including SLiM/CRAB; and (2) clinical appropriateness for high-dose therapy and ASCT as determined by a transplant physician, considering disease status, performance status, comorbidities, organ function, and overall fitness. At minimum, CMS should explicitly cover ASCT for patients with active multiple myeloma across ISS stages I, II, and III. The more durable solution is to remove prognostic stage from the coverage determination entirely. This would preserve the original policy’s appropriate intent—avoiding high-dose therapy for patients without treatment-requiring disease—while aligning Medicare coverage with modern myeloma diagnosis, randomized evidence, and clinical practice. Thank you for your consideration. Carmen Wilson, PA-C Less I am a PA specializing in multiple myeloma, hematopoietic cell transplantation and cellular therapy at Siteman Cancer Center. I strongly support CMS’s reconsideration of National Coverage Determination (NCD) 110.23. However, the proposed revision—adding the International Staging System (ISS) alongside Durie-Salmon stage II/III—preserves the central flaw in the current policy: prognostic stage should not determine Medicare coverage for autologous stem cell transplantation (ASCT). The More
Sidana, Surbhi	Title: Associate Professor Organization: Stanford University Date: 08/14/2026 Comment: Autologous stem cell transplant has shown PFS benefit in all sub-groups of patients with MM, including those with ISS stage 1 disease. These patients were part of all the randomized trials of transplant. Therefore, all patients with myeloma who are deemed eligible for transplant and wish to pursue it, should be allowed to proceed with transplant and not arbitrarily restricted based on ISS stage.
JANAKIRAM, MURALI	Title: MD Organization: CITY OF HOPE Date: 08/14/2026 Comment: I have cared for Medicare beneficiaries undergoing autologous transplantation for myeloma throughout my career, and I write to comment on the proposed revision to NCD 110.23, section B.II.b. I support CMS's decision to move beyond the Durie-Salmon staging system, which has been abandoned in clinical practice for the reasons the memorandum lays out. However, the proposed manual language, which covers single AuSCT only for “Stage II or III patients using Durie Salmon or International Staging System and its revisions,” would create a serious new problem while fixing an old one. It would, for the first time, remove guaranteed coverage from ISS stage I beneficiaries. I urge CMS to remove staging as a coverage criterion entirely, or, at minimum, to state explicitly that ISS stages I, II, and III are all covered. First, staging in myeloma is prognostic, not predictive of transplant benefit. The ISS and its revisions were built to estimate survival, not to select transplant candidates, and the memorandum's own evidence review evaluates them as prognostic tools. None of the randomized trials that established autologous transplantation as standard of care restricted enrollment by stage, and the progression-free survival benefit of transplant was observed across risk groups. In the DETERMINATION trial (Richardson et al., N Engl J Med 2022;387:132-147), patients across all ISS stages, including stage I, derived benefit from transplantation. A stage I patient is not a patient who needs transplant less. She / he is often the patient who gains the longest remission from it. Second, the proposed change is a contraction disguised as an expansion. Durie-Salmon stage I describes low-burden disease that today rarely meets IMWG criteria for treatment at all, so under the current NCD nearly every symptomatic patient fell into DS stage II or III and the restriction excluded almost no one. ISS stage I is different: it is defined only by a beta-2 microglobulin below 3.5 mg/L and albumin of 3.5 g/dL or higher, and it accounts for roughly one third of newly diagnosed patients. Carrying the words “stage II or III” from one system to the other transfers the numerals without the clinical meaning. The practical effect would be to strip coverage from the third of beneficiaries with the best expected transplant outcomes and the lowest treatment-related mortality. Third, the language as written is unadministrable. A patient can be ISS stage I but R-ISS stage II, or ISS stage I but R2-ISS stage III, on the basis of del(17p), t(4;14), or 1q abnormalities. The phrase “ISS and its revisions” does not specify which system governs when they disagree. R2-ISS also has four stages, so a plain reading of “stage II or III” would exclude R2-ISS stage IV, the highest-risk group in that system. Hundreds of transplant programs and Medicare contractors would each resolve these ambiguities differently. Fourth, no clinical guideline and no other major payer uses stage as a gatekeeper for transplantation. NCCN, ASTCT, IMWG, and the EHA-ESMO guidelines cited in the memorandum all recommend transplant for transplant-eligible newly diagnosed myeloma regardless of stage. Eligibility rests on the presence of active disease requiring therapy under IMWG criteria, together with adequate organ function and fitness, which the NCD already requires. Requested change: strike the staging requirement from section B.II.b, so that single AuSCT is covered for beneficiaries with newly diagnosed or responsive multiple myeloma and adequate cardiac, renal, pulmonary, and hepatic function. If CMS concludes that a staging reference must remain, the language should read “ISS stages I, II, or III, or the corresponding stages of its revisions.” Thank you for the opportunity to comment. Less I have cared for Medicare beneficiaries undergoing autologous transplantation for myeloma throughout my career, and I write to comment on the proposed revision to NCD 110.23, section B.II.b. I support CMS's decision to move beyond the Durie-Salmon staging system, which has been abandoned in clinical practice for the reasons the memorandum lays out. However, the proposed manual language, which covers single AuSCT only for “Stage II or III patients using Durie Salmon or International More
Kanakry, Jennifer	Title: Medical Director, Stem Cell Transplantation Organization: MedStar Georgetown University Hospital Date: 08/13/2026 Comment: August 13, 2026 Centers for Medicare & Medicaid Services Coverage and Analysis Group 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum CAG-00444R2, Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma To the Coverage and Analysis Group: I am a Professor of Oncology and staff physician in Hematology/Oncology and Stem Cell Transplantation at MedStar Georgetown University Hospital, where I oversee the cell therapy care of patients coming to Georgetown from across the DC region. Our largest patient population is mulitple myeloma patients and autologous transplant remains the standard of care for upfront therapy in transplant eligible patients. I have cared for Medicare beneficiaries undergoing autologous transplantation for myeloma, and I write to comment on the proposed revision to NCD 110.23, section B.II.b. I support CMS's decision to move beyond the Durie-Salmon staging system, which has been abandoned in clinical practice for the reasons the memorandum lays out. However, the proposed manual language, which covers single AuSCT only for “Stage II or III patients using Durie Salmon or International Staging System and its revisions,” would create a serious new problem while fixing an old one. It would, for the first time, remove guaranteed coverage from ISS stage I beneficiaries. I urge CMS to remove staging as a coverage criterion entirely, or, at minimum, to state explicitly that ISS stages I, II, and III are all covered. First, staging in myeloma is prognostic, not predictive of transplant benefit. The ISS and its revisions were built to estimate survival, not to select transplant candidates, and the memorandum's own evidence review evaluates them as prognostic tools. None of the randomized trials that established autologous transplantation as standard of care restricted enrollment by stage, and the progression-free survival benefit of transplant was observed across risk groups. In the DETERMINATION trial (Richardson et al., N Engl J Med 2022;387:132-147), patients across all ISS stages, including stage I, derived benefit from transplantation. A stage I patient is not a patient who needs transplant less. She / he is often the patient who gains the longest remission from it. Second, the proposed change is a contraction disguised as an expansion. Durie-Salmon stage I describes low-burden disease that today rarely meets IMWG criteria for treatment at all, so under the current NCD nearly every symptomatic patient fell into DS stage II or III and the restriction excluded almost no one. ISS stage I is different: it is defined only by a beta-2 microglobulin below 3.5 mg/L and albumin of 3.5 g/dL or higher, and it accounts for roughly one third of newly diagnosed patients. Carrying the words “stage II or III” from one system to the other transfers the numerals without the clinical meaning. The practical effect would be to strip coverage from the third of beneficiaries with the best expected transplant outcomes and the lowest treatment-related mortality. Third, the language as written is unadministrable. A patient can be ISS stage I but R-ISS stage II, or ISS stage I but R2-ISS stage III, on the basis of del(17p), t(4;14), or 1q abnormalities. The phrase “ISS and its revisions” does not specify which system governs when they disagree. R2-ISS also has four stages, so a plain reading of “stage II or III” would exclude R2-ISS stage IV, the highest-risk group in that system. Hundreds of transplant programs and Medicare contractors would each resolve these ambiguities differently. Fourth, no clinical guideline and no other major payer uses stage as a gatekeeper for transplantation. NCCN, ASTCT, IMWG, and the EHA-ESMO guidelines cited in the memorandum all recommend transplant for transplant-eligible newly diagnosed myeloma regardless of stage. Eligibility rests on the presence of active disease requiring therapy under IMWG criteria, together with adequate organ function and fitness, which the NCD already requires. Requested change: strike the staging requirement from section B.II.b, so that single AuSCT is covered for beneficiaries with newly diagnosed or responsive multiple myeloma and adequate cardiac, renal, pulmonary, and hepatic function. If CMS concludes that a staging reference must remain, the language should read “ISS stages I, II, or III, or the corresponding stages of its revisions.” Thank you for the opportunity to comment. Sincerely, Jennifer Kanakry Medical Director, Stem Cell Transplant and Cellular Immunotherapy Program MedStar Georgetown University Hospital Washington, DC 20007 Less August 13, 2026 Centers for Medicare & Medicaid Services Coverage and Analysis Group 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum CAG-00444R2, Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma To the Coverage and Analysis Group: I am a Professor of Oncology and staff physician in Hematology/Oncology and Stem Cell Transplantation at MedStar Georgetown University Hospital, where I oversee the cell therapy care More
Stockerl-Goldstein, Keith	Title: Professor of Medicine Organization: Washington University Date: 08/11/2026 Comment: The consensus of myeloma experts such as the IMWG and NCCN support the use of autologous transplant for patients with multiple myeloma at all stages. There are no data to support removing transplant as an appropriate therapy for patients with Stage I disease.
VIJ, RAVI	Title: PROFESSOR OF MEDICINE Organization: WASHINGTON UNIVERSITY Date: 08/11/2026 Comment: I AM WRITING TO SEEK CNTINUED COVERAGE OF AUTOLOGOUS STEM CELL TRANSPLANTATION FOR MULTIPLE MYELOMA IRRESPECTIVE OF ISS-R STAGE OF DISEASE AS THIS HAS BEEN A STANDARD OF CARE FOR NEARLY 3 DECADES. AUTOLOGOUS TRANSPLANT HAS PAIN SHOWN TO BENEFIT PATIENTS WITH MULTIPLE MYELOMA IRRESPECTIVE OF STAGE AND ADDS TO BOTH PROGRESSION-FREE AND POTENTIALLY OVERALL SURVIVAL FOR THESE PATIENTS AND DENIAL OF THIS BENEFIT TO ISS 1 STAGE DISEASE PATIENTS WOULD BE DETRIMENTAL TO THE OUTCOME
Portuguese, Andrew	Title: Assistant Professor Organization: Fred Hutchinson Cancer Center Date: 08/11/2026 Comment: To the Centers for Medicare & Medicaid Services: I am a physician specializing in multiple myeloma and hematopoietic cell transplantation at the Fred Hutchinson Cancer Center. I strongly support CMS’s reconsideration of National Coverage Determination (NCD) 110.23. However, the proposed revision—adding the International Staging System (ISS) alongside Durie-Salmon stage II/III—preserves the central flaw in the current policy: prognostic stage should not determine Medicare coverage for autologous stem cell transplantation (ASCT). The historical reason for the Durie-Salmon restriction is important. When Durie-Salmon staging was introduced in 1975, smoldering multiple myeloma had not yet been defined. Durie-Salmon stage I therefore included a heterogeneous mixture of patients with active myeloma and patients who today would be classified as having smoldering myeloma. Excluding stage I patients from the early pivotal ASCT trials was reasonable because investigators appropriately sought to avoid exposing patients with asymptomatic disease to high-dose chemotherapy. Those trial eligibility criteria ultimately became embedded in the NCD. That problem has since been solved—not by a newer prognostic staging system, but by modern diagnostic criteria. The International Myeloma Working Group now clearly distinguishes smoldering from active multiple myeloma using SLiM/CRAB criteria. ISS and its revisions serve a different purpose: they estimate prognosis after active myeloma has been diagnosed. An ISS stage I patient with SLiM/CRAB-defined active myeloma is therefore fundamentally different from the heterogeneous Durie-Salmon stage I population that motivated the original restriction. Treating the two staging systems as interchangeable is an apples-to-oranges comparison. Contemporary randomized evidence also demonstrates that ASCT benefit is not confined to higher ISS stages. IFM 2009 showed improved progression-free survival (PFS) with upfront ASCT, including in the prespecified ISS stage I subgroup (Attal et al., N Engl J Med. 2017). DETERMINATION confirmed a substantial PFS benefit with upfront ASCT, again including ISS stage I disease (Richardson et al., N Engl J Med. 2022). EMN02/HO95 demonstrated improved PFS with ASCT versus non-transplant intensification across ISS stages I–III (Cavo et al., Lancet Haematol. 2020), and FORTE likewise supported upfront ASCT across ISS subgroups, including stage I (Gay et al., Lancet Oncol. 2021). These trials provide no evidence basis for denying ASCT coverage solely because a patient with active myeloma has favorable prognostic stage. The proposed policy would therefore create a new and clinically unjustified exclusion: Medicare beneficiaries with unequivocally active, treatment-requiring myeloma could be denied ASCT simply because they have ISS stage I disease. Favorable prognosis is not evidence that transplantation is unnecessary. I urge CMS to eliminate stage-based eligibility requirements rather than substitute ISS for Durie-Salmon. Coverage should be based on (1) active multiple myeloma requiring therapy by contemporary diagnostic criteria, including SLiM/CRAB; and (2) clinical appropriateness for high-dose therapy and ASCT as determined by a transplant physician, considering disease status, performance status, comorbidities, organ function, and overall fitness. At minimum, CMS should explicitly cover ASCT for patients with active multiple myeloma across ISS stages I, II, and III. The more durable solution is to remove prognostic stage from the coverage determination entirely. This would preserve the original policy’s appropriate intent—avoiding high-dose therapy for patients without treatment-requiring disease—while aligning Medicare coverage with modern myeloma diagnosis, randomized evidence, and clinical practice. Thank you for your consideration. Sincerely, Andrew Portuguese, MD Assistant Professor Fred Hutchinson Cancer Center Less To the Centers for Medicare & Medicaid Services: I am a physician specializing in multiple myeloma and hematopoietic cell transplantation at the Fred Hutchinson Cancer Center. I strongly support CMS’s reconsideration of National Coverage Determination (NCD) 110.23. However, the proposed revision—adding the International Staging System (ISS) alongside Durie-Salmon stage II/III—preserves the central flaw in the current policy: prognostic stage should not determine Medicare coverage More
Costa, Luciano	Title: MD, PhD Organization: University of Alabama at Birmingham Date: 08/11/2026 Comment: I am a physician specialized in multiple myeloma with ample explerience in all aspects of care including autologous stem cell transplantation. The role of transplant in general is being questioned in a series of ongoing, well designed clinical trials. At present time autologous transplantation is an evidence-based, safe and, when compared to newer therapies, affordable treatment that extends PFS . There is no evidence limiting the benefit of transplantation to patients with Durie-Salmon stages 2 and 3. In fact, this very staging system is outdated, has little prognostic value and was never predictive of benefit of stem cell transplantation. Coverage for transplantation should apply to patients with symptomatic myeloma, irrespective of staging. Less I am a physician specialized in multiple myeloma with ample explerience in all aspects of care including autologous stem cell transplantation. The role of transplant in general is being questioned in a series of ongoing, well designed clinical trials. At present time autologous transplantation is an evidence-based, safe and, when compared to newer therapies, affordable treatment that extends PFS . There is no evidence limiting the benefit of transplantation to patients with Durie-Salmon stages More
Anwer, Faiz	Title: Professor of medicine, staff physician. Organization: Cleveland Clinic Date: 08/11/2026 Comment: August 11, 2026 Centers for Medicare & Medicaid Services Coverage and Analysis Group 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum CAG-00444R2, Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma To the Coverage and Analysis Group: I am a Professor of Medicine and staff physician in Hematology/Oncology and Stem Cell Transplantation at the Cleveland Clinic Taussig Cancer Center, where I direct the inpatient lymphoma and myeloma service. I have cared for Medicare beneficiaries undergoing autologous transplantation for myeloma throughout my career, and I write to comment on the proposed revision to NCD 110.23, section B.II.b. I support CMS's decision to move beyond the Durie-Salmon staging system, which has been abandoned in clinical practice for the reasons the memorandum lays out. However, the proposed manual language, which covers single AuSCT only for “Stage II or III patients using Durie Salmon or International Staging System and its revisions,” would create a serious new problem while fixing an old one. It would, for the first time, remove guaranteed coverage from ISS stage I beneficiaries. I urge CMS to remove staging as a coverage criterion entirely, or, at minimum, to state explicitly that ISS stages I, II, and III are all covered. First, staging in myeloma is prognostic, not predictive of transplant benefit. The ISS and its revisions were built to estimate survival, not to select transplant candidates, and the memorandum's own evidence review evaluates them as prognostic tools. None of the randomized trials that established autologous transplantation as standard of care restricted enrollment by stage, and the progression-free survival benefit of transplant was observed across risk groups. In the DETERMINATION trial (Richardson et al., N Engl J Med 2022;387:132-147), patients across all ISS stages, including stage I, derived benefit from transplantation. A stage I patient is not a patient who needs transplant less. She / he is often the patient who gains the longest remission from it. Second, the proposed change is a contraction disguised as an expansion. Durie-Salmon stage I describes low-burden disease that today rarely meets IMWG criteria for treatment at all, so under the current NCD nearly every symptomatic patient fell into DS stage II or III and the restriction excluded almost no one. ISS stage I is different: it is defined only by a beta-2 microglobulin below 3.5 mg/L and albumin of 3.5 g/dL or higher, and it accounts for roughly one third of newly diagnosed patients. Carrying the words “stage II or III” from one system to the other transfers the numerals without the clinical meaning. The practical effect would be to strip coverage from the third of beneficiaries with the best expected transplant outcomes and the lowest treatment-related mortality. Third, the language as written is unadministrable. A patient can be ISS stage I but R-ISS stage II, or ISS stage I but R2-ISS stage III, on the basis of del(17p), t(4;14), or 1q abnormalities. The phrase “ISS and its revisions” does not specify which system governs when they disagree. R2-ISS also has four stages, so a plain reading of “stage II or III” would exclude R2-ISS stage IV, the highest-risk group in that system. Hundreds of transplant programs and Medicare contractors would each resolve these ambiguities differently. Fourth, no clinical guideline and no other major payer uses stage as a gatekeeper for transplantation. NCCN, ASTCT, IMWG, and the EHA-ESMO guidelines cited in the memorandum all recommend transplant for transplant-eligible newly diagnosed myeloma regardless of stage. Eligibility rests on the presence of active disease requiring therapy under IMWG criteria, together with adequate organ function and fitness, which the NCD already requires. Requested change: strike the staging requirement from section B.II.b, so that single AuSCT is covered for beneficiaries with newly diagnosed or responsive multiple myeloma and adequate cardiac, renal, pulmonary, and hepatic function. If CMS concludes that a staging reference must remain, the language should read “ISS stages I, II, or III, or the corresponding stages of its revisions.” Thank you for the opportunity to comment. Sincerely, Faiz Anwer, M.D., F.A.C.P. Professor of Medicine, Department of Medicine Cleveland Clinic Lerner College of Medicine Case Western Reserve University School of Medicine Multiple Myeloma Program Hematology, Oncology, Stem Cell Transplantation Director, Inpatient Lymphoma Myeloma Service Taussig Cancer Center, 9500 Euclid Ave, CA60, Cleveland, OH 44195 Cleveland Clinic, 10201 Carnegie Ave, Cleveland, OH 44195 Fax: 216-444-9464 Less August 11, 2026 Centers for Medicare & Medicaid Services Coverage and Analysis Group 7500 Security Boulevard Baltimore, MD 21244 Re: Proposed Decision Memorandum CAG-00444R2, Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma To the Coverage and Analysis Group: I am a Professor of Medicine and staff physician in Hematology/Oncology and Stem Cell Transplantation at the Cleveland Clinic Taussig Cancer Center, where I direct the inpatient More
Schroeder, Mark	Date: 08/11/2026 Comment: High dose chemotherapy and autologous transplant should be covered for all newly diagnosed myeloma patients regardless of staging based on evidence from the DETERMINATION trial.
Sborov, Douglas	Title: Professor Date: 08/11/2026 Comment: Staging should not be used to determine eligibility/reimbursement for autologous stem cell transplantation for multiple myeloma.
Banerjee, Rahul	Title: Associate Professor Organization: Fred Hutchinson Cancer Center Date: 08/10/2026 Comment: Thank you for reviewing the NCD around autologous stem cell transplantation (ASCT) coverage in multiple myeloma. In brief, many of us realized too late that the letter you received dated June 9, 2025 (signed by Oliver Kim, whom I have spoken directly with) incorrectly stated the question at hand. The question is not whether Durie-Salmon or ISS staging is superior; instead, it is whether staging has any relevance toward ASCT eligibility or outcomes in multiple myeloma. The short answer is no. There is no reason why Stage 1 patients should be deprived of access to ASCT. All clinical trials in the modern era of newly diagnosed myeloma have included Stage 1 patients regardless of what staging criteria are used. Similarly, neither commercial insurers nor any transplant physician in the country use staging of any type to determine who will benefit from transplantation versus who won't. I have spoken with leadership at ASH and IMF (who had signed onto the original letter), and they were not aware of this letter - nor were any of us in the myeloma field. We ask that staging should be removed entirely from ASCT eligibility criteria for myeloma to avoid disparities for Medicare patients. They should have the same access to care as Americans with commercial insurance. Alternatively, if it more appropriate to list that ISS Stage 1-3 patients are eligible (namely, including Stage 1), that is sufficient as well. We are working as a field urgently to generate more public comments, including from professional societies, to supplement these individual comments. Thank you again for your consideration, and - as a myeloma expert myself - I am sincerely apologetic that our field did not provide you with the correct request back in 2025. We are working to fix this now! Less Thank you for reviewing the NCD around autologous stem cell transplantation (ASCT) coverage in multiple myeloma. In brief, many of us realized too late that the letter you received dated June 9, 2025 (signed by Oliver Kim, whom I have spoken directly with) incorrectly stated the question at hand. The question is not whether Durie-Salmon or ISS staging is superior; instead, it is whether staging has any relevance toward ASCT eligibility or outcomes in multiple myeloma. The short answer is More
Fay, Rebecca	Title: CMS amend §110.23 Date: 08/10/2026 Comment: I support the request per the explanation in the letter because there is additional scientific evidence regarding the use of ISS and its revisions when identifying covered indications of multiple myeloma. This evidence was not considered during the most recent review of NCD §110.23, and if it had been considered, it would have warranted a change to the NCD decision for AuSCT. The adoption of ISS as a preferred staging system for multiple myeloma is well supported in the medical literature, which we include as a list of citations in the appendix. Durie-Salmon was developed in 1975 and utilized clinical parameters that were “commonly available” at that time, but clinical advances have led to more contemporary prognostic staging systems.3 For example, the National Comprehensive Cancer Network (NCCN) references ISS and the two ISS revisions in its version 4.2024 guidelines.' American Society of Hematology Association of Cancer Care Centers Corewell Health International Myeloma Foundation Medical University of South Carolina, Hollings Cancer Center Less I support the request per the explanation in the letter because there is additional scientific evidence regarding the use of ISS and its revisions when identifying covered indications of multiple myeloma. This evidence was not considered during the most recent review of NCD §110.23, and if it had been considered, it would have warranted a change to the NCD decision for AuSCT. The adoption of ISS as a preferred staging system for multiple myeloma is well supported in the medical literature, More

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Autologous Stem Cell Transplantation (AuSCT) for Multiple Myeloma (MM)

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