National Coverage Analysis (NCA) View Public Comments

Stem Cell Transplantation (Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease)

Public Comments

Commenter Comment Information
deRogatis, Lorraine Date: 11/28/2015
Comment:
I urge you to revise your proposed paremeters to ensure that clinical studies make stem cell transplant an option for all MPN patients.
Krishnamurti, Lakshmanan Title: Professor Pediatrics, Director BMT
Organization: Emory University, Childrens Helathcare of Atlanta, Atlanta, GA
Date: 11/28/2015
Comment:

We appreciate the thorough analysis of the published evidence in support of hematopoietic stem cell transplantation( HCT) for sickle cell disease. We also express our appreciation of the recognition by CMS of the serious medical consequences of sickle cell disease and the willingness of CMS to support HCT for sickle cell disease. We recognize that the evidence of the efficacy of HCT for sickle cell disease is based on clinical trials that have enrolled relatively small numbers of patients

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Kruszewski, Reid Date: 11/28/2015
Comment:
I am strongly in favor of CMS providing coverage for allogeneic SCT for these conditions, and would urge CMS to not require enrollment only through a study with a control, non-SCT, group. All Medicare Myelofibrosis patients need to have access to this important potential cure based on their hematologist recommendation for their treatment strategy.
Fisher, Mildred Date: 11/28/2015
Comment:
I appreciate your effort to help medicare patients to be able to have stem cell transplants.However there seems to be to many restrictions on the availablility for them to have one. Our lives depend 0n it. Thank you for your help.
Hjerpe, Antje Title: President
Organization: MPN Education Foundation MPN-NET
Date: 11/28/2015
Comment:

Dear Commissioner,

[PHI Redacted] patient with post Essential Thrombocythemia-myelofibrosis and an active participant on MPN-NET, an online, mutual help group for all patients with Philadelphia negative myeloproliferative neoplasms, including primary myelofibrosis. The proposed change to require transplant candidates who seek Medicare coverage for the procedure to be enrolled in a clinical trial with contemporaneous controls is designed to advance medical science,

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Smith, Rachel Title: Registered nurse
Date: 11/28/2015
Comment:
PLEASE be SURE that stem cell transplantation is an option for ALL Myelofibrosis patients, and not just a subset of those as part of a study. The option for access to all Medicare Myelofibrosis patients will save and enhance the lives of many Myelofibrosis patients, and their families, where their hematologists recommend an allogeneic transplant.
Alexander, David Organization: MPN Education Foundation MPN-NET
Date: 11/28/2015
Comment:

Dear Commissioner,

[PHI Redacted] patient with polycythemia vera and an active participant on MPN-NET, an online, mutual help group for all patients with Philadelphia negative myeloproliferative neoplasms, including primary myelofibrosis. The proposed change to require transplant candidates who seek Medicare coverage for the procedure to be enrolled in a clinical trial with contemporaneous controls is designed to advance medical science, but will not because the

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Kruszewski, Ron Date: 11/28/2015
Comment:
Dear Sir/Ms: I've read that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis. That's a most encouraging development. However, I encourage CMS to consider removing the requirement for this to be available for Myelofibrosis patients only approved for a study. Please open this coverage up to any Medicare Myelofibrosis patients that their hematologist believes that an allogeneic transplant is in the best interest for the long term health of the patient.
Andritsos, MD, Leslie Title: Director of Clinical Operations, Division of Hemat
Organization: Bone Marrow Transplant Program at the James Cancer Hospital and Solove Research Institute at The Ohio State University
Date: 11/28/2015
Comment:

November 28, 2015

To Whom It May Concern:

This letter is in response to the recent CMS proposal regarding changes in coverage for allogeneic transplantation for the treatment of multiple myeloma, myelofibrosis, and sickle cell disease. CMS has proposed to cover items and services necessary for research under §1862(a)(1)(E) using the Coverage with Evidence Development (CED) paradigm. The Blood and Marrow Transplant Program at the James Cancer Hospital and Richard J Solove

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Goldstein, MD, Steven C. Title: Associate Clinical Director, Adult Blood and Marro
Organization: University of Michigan Comprehensive Cancer Center
Date: 11/28/2015
Comment:

I would like to express my strongest support for extending Medicare coverage to patients with Myelofibrosis. As a transplant physician at the University of Michigan, it is a heartwrenching to have patients with life-threatening illnesses which are potentially curable with stem cell transplants but are not within reach for patients based on their insurance. Capturing the outcome data from these transplants is essential in advancing the field and the experience CMS has gained in supporting

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Hari MD, Parameswaran Title: Armand Quick - William Stapp Professor of Hematolo
Organization: Medical College of Wisconsin
Date: 11/28/2015
Comment:

CMS Draft Decision Memo Regarding Reimbursement for Hematopoietic Stem Cell Transplantation in Myeloma Medicare Beneficiaries

On October 29, the Centers for Medicare and Medicaid Services (CMS) issued a proposed decision memo regarding Medicare coverage for allogeneic hematopoietic cell transplant (HCT) for three

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Roddy, PharmD, BCOP, Julianna Date: 11/28/2015
Comment:

To Whom it may concern:

This letter is in regards to the recent announcement for the proposal coverage of allogeneic transplantation for multiple myeloma, myelofibrosis, and sickle cell disease. We appreciate that CMS is offering trying to cover items and services necessary for research under §1862(a)(1)(E) for allogeneic HSCT for certain Medicare beneficiaries with multiple myeloma, myelofibrosis, and sickle cell disease  using the Coverage with Evidence Development (CED)

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Bodle, Ethan Title: Dr
Date: 11/27/2015
Comment:

While I am strongly in favor of covering HCST for Multiple Myeloma; (2) Sickle Cell Disease; and (3) Myelofibrosis, O believe it is unethical to link such coverage to participation in clinical trials. This amounts to coercion of patients to participate in research. Furthermore, the requirement for a so-called control group which is denied life-saving therapy is also unethical. Existing epidemiological data on untreated outcomes already exists for these patients, as does data on HCST

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Connell, Patricia Date: 11/27/2015
Comment:

[PHI Redacted] diagnosed with polycythemia vera ten years ago. [PHI Redacted] diagnosed with moderate myelofibrosis, secondary to PV, and recent blood work seems to indicate that the myelofibrosis may be progressing. I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with myelofibrosis, however requiring concurrent controls in these clinical studies might limit access to this important and potentially lifesaving therapy. I

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CONNELL, JACK Date: 11/27/2015
Comment:

[PHI Redacted] was diagnosed with polycythemia vera ten years ago. Two years ago she was diagnosed with moderate myelofibrosis, secondary to PV, and recent blood work seems to indicate that the myelofibrosis may be progressing. I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with myelofibrosis, however requiring concurrent controls in these clinical studies might limit her access to this important and potentially lifesaving therapy. I urge

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delevie, raymond Date: 11/27/2015
Comment:

These comments are offered in support of my friend who was diagnosed more than two years ago as having myelofibrosis. They are also motivated by public interest considerations.

On January 23, 2015, Be the Match and other organizations formally requested that the Centers for Medicare and Medicaid Services (CMS) reconsider its National Coverage Determination(NCD) in section 110.8.1 of the Medicare National Coverage Determination Manual for allogenic hematopoietc stem cell

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Tober, Jim Date: 11/27/2015
Comment:
On behalf of a relative and many other MPN patients, I urge the agency to revise the proposed rule to enable all of those who might benefit from stem cell transplantation to have access to the procedure without the requirement to participate in a clinical trial with concurrent control.
Roth, Gabe Date: 11/27/2015
Comment:

I am commenting on proposed rule CAG-00444R, which would allow for blood stem cell transplants for myelofibrosis patients to be covered by Medicare only under trial-like conditions, where half would receive a life-saving transplant and the other half would not.

This proposal does not go far enough, as research and practice for this disease have proven one thing – a transplant is the lone way to cure MF. There is no drug therapy that can treat it.

In a recent interview in

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Whitman, Brian Title: Senior Manager, Policy and Practice
Organization: American Society of Hematology
Date: 11/27/2015
Comment:

Comments from the American Society of Hematology are below. A signed letter with the same comments will be submitted as well.

November 27, 2015

Tamara Syrek-Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Office of Clinical Standards and Quality
Coverage and Analysis Group
7500 Security Boulevard, Mail Stop C1-09-06
Baltimore, Maryland 21244-1850

Dear Ms. Syrek-Jensen:

The

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Bernhard, Laura Organization: Cleveland Clinic
Date: 11/27/2015
Comment:

Comments regarding proposed decision on Medicare coverage for HCT for Multiple Myeloma, Sickle Cell Disease and Myelofibrosis-

These are rare disease! Please consider alternate frameworks similar to the Breakthrough and Accelerated Approval Processes utilized by the FDA for orphan conditions.

Remove the requirement for concurrent non-HCT controls. Patients will be seeking any and all curative options for their illness, making it unlikely for them to consent to

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Richards, Jody Date: 11/26/2015
Comment:

Please consider removing the requirement for controls in clinical studies of stem cell transplants on MPN patients so that ALL MPN patients can have the option of having such treatment covered by their health insurance. It is their only chance for a cure.

Thank you.
Davis, Valene Date: 11/26/2015
Comment:

Please make the decision based on if your loved one had this disease. It's the ONLY chance for a cure and some people like [PHI Redacted] have 30+ years left in them. Please don't deny that for her and others!

Lech, Ronald Title: Mr.
Date: 11/26/2015
Comment:
I encourage CMS not to limit coverage for Myelofibrosis patients. Stem cell transplants are the only life saving options and should be available to all MPN patients.
Myruski, Barbara Title: MS
Date: 11/26/2015
Comment:

[PHI Redacted] diagnosed in 2011 with Myelofibrosis and to many doctors before that bone marrow test that confirmed [PHI Redacted] The problem is many insurances and also medicare dosen't seem to know much about it or cover the treatment for it. [PHI Redacted] should be given a chance to live the same as everyone else and insurance should be covering the cost as do other cancers. This is cancer of the bone marrow and the blood. Please

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anders, cynthia Date: 11/25/2015
Comment:

Just because it is a supposedly rare disease, you should not discriminate.

[PHI Redacted] breast cancer in 1972, it was a rare disease. Now every other woman I know has had it and I'm sure it has been in your family also.

Rare is if you don't have it, if you have it, it isn't rare.
Be fair to all diseases that would be helped by transplant

Holmberg, Leona Title: Member
Organization: Fred Hutchinson Cancer Research Center
Date: 11/25/2015
Comment:

In Multiple Myeloma , there are recent concensus guidelines published for salvage allogeneic TX ( S Giralt et al Biol of Blood and BM Transpl, vol21, page 2039, v 21, 2015). Overall allogeneic TX is reasonable to consider in patient with early relapse after primary therapy ie 24 months after primary therapy including auto TX and/or high-risk cytogenetics, plasma cell leukemia etc). Preference though is to enroll on clinical trial . I agree that prspective randomzied trials are

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Gilman, Andrew Title: Director, Blood and Marrow Transplantation
Organization: Levine Children's Hospital
Date: 11/25/2015
Comment:
I think that it's very important that patients have access to transplantation for these diseases when clinically indicated and in the setting of clinical trials when appropriate. There are at least hundreds of patients that have benefited from transplant for these diseases. While controlled trials to prove benefit are appropriate in certain settings and are desirable, appropriate controls are not always available or useful. For example, in sickle cell disease, if overall survival is the

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Scott, Bart Title: Associate Professor
Organization: Fred Hutchinson Cancer Reserach Center
Date: 11/25/2015
Comment:
Stem Cell Transplantation is indicated for myelofibrosis. A retrospective analysis showed improved survival with stem cell transplant in patients with Myelofibrosis who have int=-2 or high risk disease by DIPSS criteria. (Kroger et al. Blood 2015;125:3347-3350). While this study was restricted to patients less than 65, there is no magical difference between 64.99 and 65. The study was restricted to this age to determine a comparable group in the DIPSS cohort.
Lee, Myrlena Title: Administrative Director
Organization: Carolinas HealthCare System, Pediatric Hematology, Oncology, BMT
Date: 11/25/2015
Comment:

Patients with myelofibrosis, multiple myeloma and sickle cell disease are currently unable to undergo allogeneic stem cell transplant if Medicare is their only coverage. These patients come to the same clinics and interact with other patients who are able to have transplant covered by third party payers such as BlueCross Blue Shield, Aetna, Cigna and United HealthCare. Allogeneic stem cell transplant is the only curative therapy for these patients. Being on the administrative side and

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Mori, Shahram Title: MD PhD
Organization: Florida Hospital
Date: 11/25/2015
Comment:
The proposed CMS suggestion, Requiring concurrent non-HCT controls will be severely impacting the access to care of a patient population whose only hope for potential cure is allogeneic transplant. The age group that is the most commonly affected is the Medicare age group of >60 years. I hope CMS will note that Commercial insurance carriers routinely provide coverage for transplantation for these disease indications which they understand to be the only potential curative measure. Stem cell

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Siegel, David Title: Chief, Myeloma Division
Organization: John Theurer Cancer Center
Date: 11/25/2015
Comment:

I am sure much of what is being sent has to do with the need to keep all treatment options available. For MM I will make a slightly different argument. We can debate whether PBSCT gives better outcomes. Certainly, it has never been shown to be inferior to alternatives, it is associated with less in the way of long-term toxicities and is the only modality that offers the opportunity to be a decade long treatment-free survivor.

My argument is more practical. At the current

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Ferrara, James Title: Professor
Organization: Mount Sinai School of Medicine
Date: 11/25/2015
Comment:
HCT is a very important therapy for these diseases. It is important to study outcomes, but having a concurrent not HCT control group may be very difficult and should not be an absolute requirement for coverage. WE should not throw up additional barriers to patients seeking touse this life-saving strategy.
Roth, Ronald Title: Rabbi
Date: 11/25/2015
Comment:
It is very simple. Blood stem cell transplants are the only cure for myelofibrosis. An experiment is not necessary. Many people will die waiting for Medicare to pay for Blood stem cell transplants. I cannot understand why it is not covered now.
Rybka, Witold Title: Professor of Medicine and Pathology
Organization: Penn State Hershey Medical Center
Date: 11/25/2015
Comment:
I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Sickle Cell, Myelofibrosis, and Multiple Myeloma. I am a physician, Director of a Bone Marrow Transplantation Program at Penn State Hershey Medical Center. We treat patients with these diseases and want to be able to offer transplantation as a treatment option for their disease. I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit Medicare

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Carrum, George Title: Director of Adult stem cell transplant program
Organization: Baylor College of Medicine
Date: 11/25/2015
Comment:
I agree with both Dr. Vose and Dr. Petersdorf.
We would need to have a control arm for each of the following diseases (Multiple Myeloma, Myelofibrosis and Sickle cell disease). similar to the MDS observational study.
Woolfrey, Ann Title: Full Member, Attending Physician
Organization: Fred Hutchinson Cancer Research Center
Date: 11/25/2015
Comment:
I serve as the medical director for the Unrelated Donor program at the Fred Hutchinson Cancer Research Center, one of the largest centers for blood and marrow transplant, and the center that pioneered the curative potential of bone marrow transplantation for leukemias. We and many others have shown that blood or marrow transplantation (BMT) is curative for sickle cell disease (Walters, et al New England Journal of Medicine), Myelofibrosis (see Deeg, et al and Scott, et al), and Multiple

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Savasan, Sureyya Title: MD
Organization: Children's Hospital of Michigan
Date: 11/25/2015
Comment:
As a BMT physician, I have observed several children with sickle cell disease treated successfully with matched sibling donor (MSD) bone marrow transplantation (BMT). Their lives have dramatically changed. It has been very obvious how happy their parents have been. Many of the patients had a CNS event leading to BMT. Although regular blood transfusions have been successful to a certain degree in such patients, still, up to 40% of the patients is at risk of stroke, silent infarcts or other

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Stiff, Patrick Title: Director Cardinal Bernardin Cancer Center
Organization: Loyola University Medical Center
Date: 11/25/2015
Comment:

To whom it may concern:

I am director of the BMT program at Loyola University Medical Center for 30 years and have published ~150 articles on BMT and hematologic malignancies including on allogeneic transplantation for myelofibrosis.

While I am supportive of each of these three indications, I am concerned given the selection process for transplant we have instituted for myelofibrosis (transfusion dependency; weight loss of > 10% due to disease; pain due to

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McGuirk, Joseph Title: Division Director, Hematologic Malignancies
Organization: The University of Kansas Cancer Center
Date: 11/25/2015
Comment:

I am the Division Director of Hematologic Malignancies and Cellular Therapeutics, and the Medical Director of the Blood and Marrow Transplant at the University of Kansas Cancer Center. I am extremely grateful that CMS is allowing coverage for multiple myeloma, sickle cell disease and myelofibrosis patients. Clinical outcomes data indicates allogeneic stem cell transplant for these indications is an optimal treatment strategy. I am confident this decision on behalf of CMS will help save

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Petersdorf, MD, Effie Title: President
Organization: American Society for Blood and Marrow Transplantation
Date: 11/25/2015
Comment:

November 24, 2015

Tamara Syrek-Jensen
Acting Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Office of Clinical Standards and Quality
Coverage and Analysis Group
7500 Security Boulevard, Mail Stop C1-09-06
Baltimore, Maryland  21244-1850

E-mail: CAGinquiries@cms.hhs.gov

RE:  National Coverage Analysis (NCA) for Stem Cell Transplantation (Multiple

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Hari, Parameswaran Title: Professor of Medicine
Organization: Medical College of Wisconsin
Date: 11/24/2015
Comment:

CMS Draft Decision Memo Regarding Reimbursement for Hematopoietic Stem Cell Transplantation in Myeloma for Medicare Beneficiaries

On October 29, the Centers for Medicare and Medicaid Services (CMS) issued a proposed decision memo regarding Medicare coverage for allogeneic hematopoietic cell transplant (HCT) for three indications – Multiple Myeloma (MM), Primary Myelofibrosis and Sickle Cell disease. While welcomeing the proposed decision to consider allogeneic HCT in myeloma, we

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Kamani, Naynesh Title: MD
Organization: self
Date: 11/24/2015
Comment:

As a transplant physician who has spent the last 15 years of my career trying to increase utilization of BMT as a curative therapy for children and young adults with sickle cell disease, I am very concerned about the CMS proposed ruling that allogeneic HSCT for sickle cell disease (SCD) will be covered by Medicare only for certain beneficiaries with sickle cell disease who participate in a prospective clinical study with concurrent non-transplanted controls. The CMS review of published data

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Sanders, Diane Date: 11/24/2015
Comment:
[PHI Redacted] was diagnosed with Myelofibrosis in 2009 and would not be alive today without the stem cell transplant. He was lucky enough to have private insurance at the time, but was forced to retire and is now covered under Medicare. Should his disease return and he be required to undergo another transplant, it would be unfathomable to think that he would be denied coverage. His life was saved and is he thriving...I find it unethical to deny that opportunity for everyone,

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Jones, Landon Title: Author and magazine editor
Organization: Time Inc.
Date: 11/24/2015
Comment:
I wish to express my strong support for Medicare coverage of SCT for Myelofibrosis. The costs are coming down, and the success rates are improving and offer not only hope but a cure. That is an investment worth making.
Selby, George Title: M.D. Director Blood/Marrow Transplantation Program
Organization: University of Oklahoma
Date: 11/24/2015
Comment:
I appreciate the efforts of CMS to broaden coverage allowing hematopoietic stem cell transplantation for patients with multiple myeloma, sickle cell diseases and myelofibrosis. However, I fear that the proposal as written will actually dissuade patients from obtaining these potentially curative therapies. A mandate to participate in a concurrently controlled trial will prove unworkable as patients will be unwilling to be randomized to a control arm when the natural histories of

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Barnes, Yvonne Title: US Medical Lead, Hematology & Transplant
Organization: Sanofi US
Date: 11/24/2015
Comment:

Sanofi US is submitting these comments in support of CAG-00444R proposed decision memorandum to expand the Medicare National Coverage policy regarding hematopoietic stem cell transplantation (HSCT). As a healthcare company backed by world class research and development, Sanofi is developing innovative therapies to help Medicare beneficiaries lead longer, healthier, and more productive lives. Our company is pursuing leading patient solutions in major therapeutic areas including oncology,

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Kramer, Lisa Title: RN, OCN, BMTCN
Organization: Hackensack University Medical Center
Date: 11/24/2015
Comment:
I applaud the CMS proposal considering coverage for allogeneic HCT for the diagnoses of myelofibrosis, Sickle Cell disease and multiple myeloma on approved clinical trials, it is a long time in coming. However, I am very concerned about the concurrent non-HCT control requirement, as these diseases are not curative outside of stem cell transplantation. Who among us, with any 1 of these 3 life limiting diagnoses, would sign onto a clinical trial where the randomization is to either the HCT arm

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Shea, Thomas Title: Professor of Medicine
Organization: UNC Chapel Hill Bone Marrow and Stem cell Transplant Program
Date: 11/24/2015
Comment:

Dear CMS;

Thank you for this opportunity to comment on the proposed guidelines for establishing guidelines regarding payment for allogeneic stem cell transplantation in patients with Myelofibrosis, Sickle Cell Anemia and Multiple Myeloma. While I understand and agree with the need to collect non-transplant control data to support the value of this approach in these conditions, I am concerned that what you have proposed will not be an acceptable option for many of these patients.

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Fergo, Therese Date: 11/24/2015
Comment:
Please allow patients to chose for themselves. We have no other alternative but to try to avail ourselves with what is available. Please do not determine who will be randomly granted to live or die. Our only hope to survive is to have access to these vital procedures.
Sincerely,
Therese Fergo
Chell, Jeffrey Title: Chief Executive Officer
Organization: National Marrow Donor Program, Be The Match
Date: 11/24/2015
Comment:

National Marrow Donor Program, Be The Match
500 N. 5th Street
Minneapolis, MN 55401

Tamara Syrek-Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Office of Clinical Standards and Quality
Coverage and Analysis Group
7500 Security Boulevard, Mail Stop C1-09-06
Baltimore, Maryland 21244-1850

November 23, 2015

The National Marrow Donor Program (NMDP) is the world’s leading nonprofit

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Tobin, Vincent Date: 11/24/2015
Comment:
I applaud CMS for its decision to cover Stem Cell transplantation for myelofibrosis patients. However, in common with virtually every other commentator, I question the need for a concurrent trial. A myelofibrosis patient only considers transplant as a last resort. Such a patient should not be required to essentially be forced into a game of “Russian roulette” in order to obtain the only possible cure for this disease. Indeed, as every one of the eminent physicians commenting has noted (see

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RIZZO, J DOUGLAS Title: SR SCIENTIFIC DIR CIBMTR, PROJ DIR. SCTOD
Organization: CIBMTR AND MEDICAL COLLEGE OF WI
Date: 11/24/2015
Comment:

November 23, 2015

CMS Coverage Analysis Group
Baltimore, MD

RE: CAG-00444R Proposed Decision for SCT

As the Project Director of the Stem Cell Therapeutic Outcomes Database (SCTOD), and Principal Investigator of the approved observational study of hematopoietic cell transplantation (HCT) in patients over age 65 with Myelodysplastic Syndrome (MDS) under CED (Protocol #: CAG-0415N), I would like to provide some perspective on the national coverage determination

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Lin, Tara Title: Assistant Professor
Organization: University of Kansas Cancer Center
Date: 11/24/2015
Comment:

I appreciate the efforts by CMS to expand coverage and access to allogeneic stem cell transplant for patients with myeloma, myelofibrosis and sickle cell disease.

I am a stem cell transplant physician at the University of Kansas Cancer Center. I have specialized in the care of patients with hematologic malignancies and bone marrow disorders for over 10 years. It is critically important that patients with these diseases be offered stem cell transplantation, as it is the only

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Harvey, Elizabeth Title: RN, CHTC, Lead Tranpslant Coordinator
Organization: University of Kansas Blood and Marrow Transplant Program
Date: 11/24/2015
Comment:
I am strongly in favor of CMS providing coverage for allogeneic SCT Multiple Myeloma, Myelofibrosis and Sickle Cell disease. I would urge CMS not to require enrollment only through a study with a control, non-SCT, group. Such a requirement has the strong potential to decrease access to SCT for patients desperately in need. I have worked in the field of transplant for 25 years. We see patient on a daily basis that had no coverage for a life saving allogeneic stem cell transplant. Thank you

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Wiegmann, Theresa L. Title: Director, Public Policy
Organization: AABB
Date: 11/24/2015
Comment:

November 25, 2015

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd., Mail Stop S3-02-01
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Stem Cell Transplantation (Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease (CAG-00444R)

Dear Ms. Jensen:

On behalf of the thousands of individual and institutional members involved in cellular therapies

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Jacknis, Martin Title: President
Date: 11/23/2015
Comment:
[PHI Redacted] had myelofibrosis, and now [PHI Redacted] also has a myeloproliferative disease. I am thankful that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis. I am concerned that the proposed changes would be too restrictive and limit life-saving care for patients in need. It would be a shame, and potentially cost valuable lives, if the proposed restrictions are enacted as now written. All MPN patients should be able

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Anschutz, Julie Title: Mrs.
Date: 11/23/2015
Comment:
I urge you to please encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy. This could be a life saving treatment and only option. Please make it as available as possible.
Kimball, Mark Date: 11/23/2015
Comment:

My family and I strongly support expansion of coverage fpr these conditions. I have a friend who has successfully undergone transplant with fantastic results but related the issues of research design and how it could have badly affected his ability to receive the treatment he needed.

Furthermore, any policy changes should apply to all who might need transplant without regard to age and CMS should provide coverage for transplant when the doctor believes it is the best treatment

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zumberg, marc Date: 11/23/2015
Comment:

research in transplant and sickle cell disease is much needed and needs to be made as easy as possible.

This is a very important topic in an underserved population.

Transplant is the only potentially curative treatment for this diseae and patients need easy access to studies

Griswold, Corinne Date: 11/22/2015
Comment:
Thank you for addressing the need to allow Medicare coverage of stem cell transplants for Myelofibrosis patients. Our family is affected by Polycythemia Vera which can progress to MF. Please ensure that the clinical studies make stem cell transplant an option for ALL MPN patients!!
Michaelis, Laura Title: Associate Professor
Organization: Medical College of Wisconsin
Date: 11/22/2015
Comment:

To the attention of: CMS Coverage Analysis Group

We, the undersigned, are writing in response to the proposed CMS rule on transplant coverage for patients with the rare form of blood cancer called Primary Myelofibrosis. Each of us is a hematologist specializing in the care of these patients and together we have a large collective experience on the management of this rare, heterogeneous and largely lethal condition.

We applaud the efforts CMS is making to codify the

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Doose, Lyn and Larry Organization: MPN Research Foundation
Date: 11/22/2015
Comment:
[PHI Redacted] has Polycythemia Vera.
Please remove the requirements for concurrent controls since it will limit [PHI Redacted] ability to access stem cell transplant therapy in the future.
Roth, Ronald Title: Rabbi
Date: 11/22/2015
Comment:
The CMS guidelines for Myelofibrosis can be read as a reasoned response to determining whether stem cell transplants should be covered or not. For many it is simply a death sentence. I don’t want to sound too melodramatic, but stem cell transplants are a lifesaving procedure, admittedly risky, but the only possibility for cure for those with that incurable disease. If patients are denied coverage, or become the “control group” in an experiment and do not receive a stem cell transplant, they

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Meacham, Nelson Date: 11/22/2015
Comment:

I support the expansion of coverage. Especially for myelofibrosis.
A good friend was diagnosed about six years ago. As a result of his transplant he now leads a full life with his family and friends.

Any policy change should apply to all who might need transplant without regard to age.

Scovill, Russell Date: 11/22/2015
Comment:
Dear CMS,
[PHI Redacted] I appreciate that CMS is trying to provide coverage for Medicare patients with myelofibrosis and I encourage you to consider removing the requirement for concurrent controls in the proposed clinical studies because it will limit patient's ability to access this lifesaving therapy. There are medications available which help with treatment of symptoms, but to date stem cell transplants are the only known cure. Thank you.
Cramer, Cassandra Title: Mrs.
Date: 11/21/2015
Comment:
I am so pleased that CMS is considering covering items and services necessary for research for allogeneic HSCT for Medicare beneficiaries with myelofibrosis!
More studies can only help all of us with myelofibosis.
Baker, Barbara Date: 11/21/2015
Comment:
CMS is considering allowing stem cell transplants in myelofibrosis patients only if a patient participates in a clinical trial that includes concurrent non-transplant controls. Designing such a study in this rare disease is highly problematic and substantially limits transplants for myelofibrosis, a terminal diagnosis. Stem cell transplants are the only known cure for the disease. Patients in the control arm would face certain death.
Johnson, Carol Title: Mrs
Organization: MPNForum
Date: 11/21/2015
Comment:
Please look carefully at the peramitures you are setting. PV is bad enough but knowing that it can morph to MF adds another layer of stress; [PHI Redacted] Don't close the gate so tight that we die asking for help
Slepicoff, Ava Date: 11/21/2015
Comment:
I urge you to revise your proposed study parameters to ensure that the clinical studies make stem cell transplant an option for ALL MPN patients. Please do not further limit our already limited options for treatment. You wouldn't want this for yourself or a loved one. Thank you for your consideration.
Perkins, Richard Date: 11/21/2015
Comment:

This letter is written in support of CMS changing its coverage policy in relationship to payment for bone marrow transplant for patients with myelofibrosis. Myelofibrosis is one of many chronic myeloid disorders. CMS has determined that bone marrow transplantation is appropriate in some of the chronic myeloid disorders but not in myelofibrosis. Since these are “overlapping” disorders, with one disorder many times progressing to another, the artificial distinctions that have been used to

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Allison, Sandra Date: 11/21/2015
Comment:

[PHI Redacted] - I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis.
I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.

Thank you for your time and consideration
Sandra Allison

Demsky, Stewart Date: 11/21/2015
Comment:
I am thankful that CMS is trying to provide coverage for certain Medicare patients with Myelofibrosis; however, we are hoping that you revise your proposed study parameters to ensure that Stem Cell transplants are an option for all MPN patients.
Luedtke, Steve Date: 11/20/2015
Comment:
I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis by removing the requirement for concurrent controls in these clinical studies.
Trullinger, Tom Date: 11/20/2015
Comment:
I would like to encourage CMS to make medicare coverage of SCT for all patients with myelofibrosis available. Thank you
Riley, Diana Date: 11/20/2015
Comment:
Please provide Medicare coverage for stem cell transplants for all MPN patients that require one. Myeloproliferative neoplasms are rare, and very few of those diagnosed with one would ever require a stem cell transplant, so the cost to Medicare would not be great. Thank you for your consideration.
Diana Riley
Weil, Kathleen Date: 11/20/2015
Comment:
I support extending coverage of this lifesaving procedure. My cousin [PHI Redacted] (now thriving 6 years post procedure) is a stunning example of the effectiveness of stem cell transplantation for Myelofibrosis. Patients whose doctors believe that this is the best treatment option should not be denied the procedure because of age.
Sincerely,
Kathleen Weil
Keasler, Caryl Date: 11/20/2015
Comment:
[PHI Redacted] a disease for which bone marrow transplantation is the ONLY curative treatment. It is difficult to qualify for a transplant after the age of 65 because you have to show strong lungs, heart, liver, kidneys, and have no other serious co-morbidities. [PHI Redacted] had been randomized to be a control. I'm not sure that is even moral, since there is no other curative treatment. Transplant is usually chosen as a last resort. Please do not

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Corlett, Thomas Date: 11/20/2015
Comment:
[PHI Redacted] very likely to require progressively intense treatment. a stem cell treatment would likely save everyone a great deal.
Please include the listed conditions in your listing.
Thank you for your work and consideration
Giliam, Jim Date: 11/20/2015
Comment:

In 2008 [PHI Redacted] was diagnosed with Primary Myelofibrosis. According to her hematologist she was in a low risk category and had a relatively good prognosis. However the first thing her hematologist did was to determine if her either of her two brothers was a suitable match for a stem cell transplant.

It is quite well recognized among the MPN expert community how PMF can progress to the point where, based on diagnostic markers an emergent situation exists,

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Inglish, David Date: 11/20/2015
Comment:
-I support expansion of coverage of treatment to include the procedure for myelofibrosis (MF), multiple myeloma and sickle cell disease. It's important that we allow medical advancements made to be available to those who truly need those cures and not exclude them from coverage under CMS.
-My friends life was saved by a stem cell transplant for myelofibrosis (MF) about 6 years ago and his life has been transformed back into a healthy and productive adult as a result of that

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Weil, Kathleen Date: 11/20/2015
Comment:
I support extending coverage of this lifesaving procedure. [PHI Redacted] (now thriving 6 years post procedure) is a stunning example of the effectiveness of stem cell transplantation for Myelofibrosis. Patients whose doctors believe that this is the best treatment option should not be denied the procedure because of age.
Sincerely,
Kathleen Weil
Maxwell, Jeff Title: Retired Teacher
Date: 11/20/2015
Comment:
I support coverage for these illnesses . [PHI Redacted] is alive today because of a non relative donor and I know first hand how expensive these procedures can be.
LeMaistre, C. Fred Title: SVP, Physician in Chief Hematology
Organization: Sarah Cannon
Date: 11/20/2015
Comment:

The Sarah Cannon Blood Cancer Network (SCBCN) is very appreciative that CMS is trying to provide a pathway to coverage for hematopoietic cell transplantation (HCT) for Sickle Cell Disease, Myelofibrosis and Multiple Myeloma.

The experience of the eight programs in the SCBCN is reflected in the more than 11,000 patients who have received HCT in our centers and the almost 1,000 patients, including over 200 Medicare beneficiaries, we will transplant this year

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Stern, Karen Date: 11/20/2015
Comment:
I have submitted a public comment regarding my hope that you would make stem cell transplants available for medicare patients with Myelofibrosis and now i want to add my voice to those who are asking that you consider removing the requirement for concurrent controls in the proposed clinical studies because it will limit patient's ability to access this lifesaving therapy. [PHI Redacted] - Thank you
McHugh, Pamela Date: 11/20/2015
Comment:

Re: Stem cell transplant for Myelofibrosis

[PHI Redacted] all others with myeloproliferative disease appreciate your efforts to provide stem cell transplants through Medicare; we would also ask that you consider removing the requirement of concurrent controls in the proposed clinical studies because it will limit [the] ability to access this only option for a cure. Thank you for your efforts thus far.

Lazare, Margaret Date: 11/20/2015
Comment:
I am writing to encourage CMS to make stem cell transplants an option for all MPN patients.I understand that CMS is trying to provide coverage for Medicare patients with myelofibrosis.[PHI Redacted] I urge CMS to to consider removing the requirement for concurrent controls in the proposed clinical studies. The consequence will be limitation of patient's ability to access this lifesaving therapy.Thank you
House, Mike Date: 11/20/2015
Comment:
Appreciate that CMS is trying to provide coverage for Medicare patients with myelofibrosis and we encourage them to consider removing the requirement for concurrent controls in the proposed clinical studies because it will limit patients abilities to find the best facilities for their individual needs.
Bender, MF, FACP, Richard A. Title: Chief Medical Officer
Organization: Signal Genetics, Inc.
Date: 11/20/2015
Comment:

Dear Ms. Gilbreath ,

As an experienced medical oncologist and Chief Medical Officer of Signal Genetics, I understand the therapeutic challenge for newly diagnosed patients with multiple myeloma with "high risk" features. Their poor outcome with standard treatment modalities including high dose melphalan and tandem HSCT is discouraging, but has prompted a great deal of clinical investigation into a more accurate definition of "high risk" and advanced therapies (including

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Lipton, Joan Date: 11/19/2015
Comment:
It is extremely important that Medicare cover stem cell transplantation for patients with myelofibrosis particularly when medication fails to control this terrible disease. The decision for stem cell transplant should be made between doctor and patients of all ages (even above 70 years of age.). If this treatment is denied, patients die
Burns, Leonora Title: Mrs
Organization: MPN-NET
Date: 11/19/2015
Comment:
I understand you are considering making it less likely that transplantation will be available for Medicare members with myelofibrosis. I don't understand why you won't cover this procedure which is currently the only possibility of cure for those of us with myelofibrosis that has no longer become manageable by medication. Please make coverage available as you do for other disease where life is at stake.
Gilliam, Marcia Title: Mrs.
Date: 11/19/2015
Comment:
My comment is that stem cell transplants should be an option for all MPN patients. I appreciate that CMS is trying to provide coverage for Medicare patients with myelofibrosis and I encourage them to remove the requirement for concurrent controls in the proposed clinical studies because it will limit patient's ability to access this lifesaving therapy.
People with myelofibrosis work, pay taxes, and pay for their health insurance all their working lives, then when they reach age 65, the

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Goyal, Rakesh Title: Clinical Director, BMT & Cellular Therapies
Date: 11/19/2015
Comment:

I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with sickle cell disease.
I am the Clinical Director, Division of Blood and Marrow Transplantation and Cellular Therapies at a top 10 Children’s Hospital. I am a clinician researcher and have over 20 years’ experience as transplant physician. We treat children, teenagers and adults with sickle cell disease and want to be able to offer transplantation as a treatment option for their disease.

I

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Dicker, Neil Title: Dr.
Date: 11/19/2015
Comment:

[PHI Redacted] Saving one life saves an entire world.

It is necessary to consider that allogenic stem cell transplants do have favorable outcomes. In many cases, to deny someone access to the transplant is the same as condemming them to death from their disease.
I would encourage CMS to provide access to all patients when this is the only treatment option, and when their doctor recommends it.
It is not reasonable that research design should result in

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Bergmann, Richard Title: Mr.
Date: 11/19/2015
Comment:
Please do not add any restrictions that will limit stem cell transplants for patients with Myelofibrosis. At this time there is only one approved medication, Jakafi, for this terrible disease. Jakafi and stem cell transplant are the only options. Please do not limit treatment options.
Thank You, Sincerely, Richard Bergmann
Brown, Randy Title: Professor of Medicine
Organization: University of Florida School of Medicine
Date: 11/19/2015
Comment:
I am thankful that CMS is considering coverage for allogeneic transplant for patients with myelofibrosis. However, given our current state of knowledge for this disease I disagree with a randomized trial as adequate information exists to show that transplant is beneficial in patients with advanced myelofibrosis. Further, this therapy is potentially curative.
Russo, Sara Date: 11/19/2015
Comment:
[PHI Redacted] with a Myelofibosis blood cancer as identified by the WHO. A Stem Cell tranpslant is a vital therapy for those of us who have this problem. Right now it is the only viable almost cure for this. All other "treatments" are off label use of the drug. And well some pharmacies just don't carry them and that's the hospitals. Don't make us plead. I'd your family members had cancer would you make them plead for a possible cure I'd they were on medicade or Medicare, I

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PARKMAN, ROBERTSON Title: RD
Organization: STANFORD UNIVERSITY
Date: 11/19/2015
Comment:
For sickle cell, the endpoint should be decreased long term costs and quality of life. A control group will be difficult since it will take decades of followup
Gollub, Michael Title: MD
Date: 11/19/2015
Comment:

As a physician with knowledge of the potential benefits for stem cell therapy for many diseases, and as the father of a young man with MPN (Polycythemia Vera), I am concerned about the restrictive nature of the changes you are contemplating.

It would be a grave injustice and likely a tragic waste of valuable lives if the restrictions are maintained as stated.

Participation in all stem cell transplantation clinical studies should be open to all MPN patients. Please

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Weber, Catherine Date: 11/19/2015
Comment:
As a clinical pharmacy specialist with 5 years of experience working with the adult BMT population, I appreciate CMS's decision to create opportunity for Medicare patients to receive access to curative therapy for MM, MF, and sickle cell disease. However, the restrictive nature of the clinical study design requirements will not serve to facilitate the expansion of care to this population. I would suggest loosening the clinical study design requirements - especially to remove the requirement

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beardell MD, frank Title: Medical Director, Christiana Care
Organization: Christiana Care Health System Wilmington, Delaware
Date: 11/19/2015
Comment:

Dear Center for Medicaid and Medicare Services,

Thank you for the opportunity to comment on the demonstration project that CMS is sponsoring to provide allogeneic bone marrow transplantation coverage for Medicare beneficiaries with sickle cell anemia, myelofibrosis and multiple myeloma. I am a bone marrow transplant physician at Christiana Care Health System and Director of the Blood and Marrow Transplant Program.

Strong data exists as to the benefit of early

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Jones, Roy Title: PhD MD Professor
Organization: M D Anderson Cancer Center, Houston, TX
Date: 11/19/2015
Comment:

Allotransplantation for myeloma, myelofibrosis and sickle cell disease is already a proven curative treatment and is routinely covered by most commercial insurance plans. For every transplant indication in patients <65 years old, data now supports efficacy in fit older patients.

Because this is understood by well-informed patients, any requirement for randomization places patients in an untenable position of having to risk not receiving a treatment for their disease recommended

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Gettleman, Joel Date: 11/19/2015
Comment:
I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.
Klein,M.D., Leonard Title: Director Stem Cell Transplantation
Organization: Advocate Lutheran General Hospital
Date: 11/19/2015
Comment:
I fully support the CMS decision NCD110.8.1 in providing financial support for Myelofibrosis and SCD. As a practicing hematologist/oncologist/stem cell transplanter for over 35 years it has been astounding how the treatments for these diseases has lagged in becoming curable. Finally we now have the capability of being able to offer a potentially curable treatment to our patients. These patients are already carefully selected to those that have a poor survival with standard only supportive

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Finch, Dean Title: Deacon
Date: 11/19/2015
Comment:

[PHI Redacted] patient with Myelofibrosis. It has advance such that [PHI Redacted] eligible for stem cell transplant. This procedure could be life saving [PHI Redacted]. Please approve this for in your budget for all such patients.

God Bless

Weisdorf, Daniel Organization: University of Minnesota
Date: 11/19/2015
Comment:
This is a wise and reasonable approach which will provide coverage and also the prospective information to assess the value of this new treatment. I fully support this proposal.
Gollub, Matthew Title: MD
Organization: Rocky Mountain Hospital for Children
Date: 11/18/2015
Comment:

Stem Cell Transplantation (Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease)

As a pediatric intensivist who cares for children and adults with myelofirbosis, I want to ensure that all patients have access to stem cell transplants. More personally, [PHI Redacted] has PCV with the early stages of myelofibrosis. Please allow [PHI Redacted] to have this life saving therapy stem cell transplants save lives.

Chung, Fred Date: 11/18/2015
Comment:
Please ensure that stem cell transplants are an option for all Medicare beneficiaries with myelofibrosis. [PHI Redacted] I freely admit that I am making this comment out of my own self interest.
McQuillin, Tim Date: 11/18/2015
Comment:
I would like CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy. It can save my friend's life.
Rovner, Marc Date: 11/18/2015
Comment:

Please amend the policy to include stem cell transplants for all MPN patients and not just those with myelofibrosis. MF is just one of three MPN conditions, including PV and ET, and all those with MPNs should have stem cell transplants as an option. Thank you.

-Marc Rovner
griffin, martin Date: 11/18/2015
Comment:

I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis and other related blood disorders.

I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.

[PHI Redacted] had a bone marrow disorder that affected her blood. [PHI Redacted] Also as an African American,

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Ferguson, Wendy Date: 11/18/2015
Comment:
I've recently learned about CMS's proposal to provide coverage for Medicare beneficiaries with Myelofibrosis, and applaud these efforts. However I am deeply concerned about the impact of concurrent controls in the clinical studies. These controls would restrict a Medicare beneficiary's ability to access this important therapy. Please make the necessary changes to the proposal to ensure that stem cell transplants are available to ALL MPN patients.
Neuringer, Leonard Date: 11/18/2015
Comment:
Dear Sir/Ms:
I've read that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis.
That's a most encouraging development.
However, I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy. Thank You, Leonard Neuringer
Hexner, Elizabeth Title: Director, Penn MPN Program
Organization: University of Pennsylvania
Date: 11/18/2015
Comment:
Thank you for thoughtful consideration for clarifying coverage for myelofibrosis, myeloma and sickle cell disease for allogeneic stem cell transplantation. I too object to the requirement for a control arm: it will markedly curtail access to transplantation and is unlikely to yield rigorous comparative data regarding outcomes.
Nakamura, Ryotaro Title: MD
Organization: City of Hope National Medical Center
Date: 11/18/2015
Comment:

I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Sickle Cell, Myelofibrosis, and Multiple Myeloma.

I am a physician at City of Hope National Medical Center. We treat patients with these diseases and want to be able to offer transplantation as a treatment option for their disease.

I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit Medicare beneficiary's ability to

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Shapiro, Tobie Helene Date: 11/18/2015
Comment:
[PHI Redacted] This is not uncommon because the disease is that rare. A world-wide medical trial can hope to gather, for example, 300 qualifiable patients to volunteer for just a chance to benefit from a new therapy. As the alternative to taking this risk is death, the reasons to participate in a trial are compelling. We are very appreciative that you are making stem cell transplantation available, but are frightened for the many patients of this rare condition who will

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weiss, allison Date: 11/18/2015
Comment:
While I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis, I urge CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.
Horowitz, Mary Title: PI, Data and Coordinating Center
Organization: Blood and Marrow Transplant Clinical Trials Network
Date: 11/18/2015
Comment:

On behalf of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), we want to thank CMS for reconsidering expansion of the national coverage determination for allogeneic transplantation to include multiple myeloma, sickle cell disease (SCD) and primary myelofibrosis (PMF). This thoughtful reconsideration is warranted given the improvements in transplant-related mortality, especially in older adults, afforded by new strategies for pretransplant conditioning and prevention of

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Bolanos-Meade, Javier Title: MD
Date: 11/18/2015
Comment:
I read that Medicare will cover for BMT in sickle cell patients "only for certain beneficiaries with sickle cell disease who participate in a prospective clinical study with concurrent non-transplanted controls." I think this is a mistake. While BMT is recognised as a curative therapy for children with SCD, transplant still needs some study. Particularly now that we know that transplants can be done using non-myeloablative approaches, the data on this approach is quite limited. Before we can

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Goorha, Salil Title: MD
Organization: Baptist Cancer Center
Date: 11/18/2015
Comment:

I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Sickle Cell disease, Myelofibrosis, and Multiple Myeloma.

I am a Salil Goorha, MD at Batist Cancer Center in Memphis, TN. We treat patients with these diseases and want to be able to offer transplantation as a treatment option for their disease.
I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit Medicare beneficiary's

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Rosendale, Martin Title: CEO
Organization: Selnova, LLC
Date: 11/18/2015
Comment:

Thank you for considering Coverage with Evidence Development (CED) for allogeneic stem cell transplantation and for providing this opportunity for public comment.

CED can be a powerful and valuable tool for collecting effectiveness data and informing future clinical and coverage decisions. I applaud CMS for proposing CED to provide Medicare Beneficiaries access to potentially effective, and possibly life-saving, therapies.

Stem cell transplantation is a rapidly growing

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Lysobey, Michael Date: 11/18/2015
Comment:
I believe it is very important for CMS to provide coverage via Medicare for those with Myelofibrosis. Thank you so much for your efforts to ensure that happens. Please consider removing the requirement for concurrent controls in these clinical studies as that will limit a Medicare beneficiary's access to this important therapy. Stem cell transplants should be an option for all patients with myeloproliferative disorders, and there should not be such undue limits on access to stem cell

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Dixon, Shonni Date: 11/18/2015
Comment:
Asking CMS torevise their study parameters to ensure that the clinical studies make stem cell transplant an optionfor all MPN patients. [PHI Redacted] Any assistance is needed for our healthy future.
Miceli, Wayne Date: 11/18/2015
Comment:
I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.
Kai, Harrison Title: Mr
Date: 11/18/2015
Comment:
MF is real and it is painful. The option to have stem cell transplantation for all MPN patients is a legitimate request. Please consider allowing all MPN patients to have access to stem cell transplantation. Thank you.
Rodriguez, Nelly Title: RN, stem cell transplant case manager
Organization: Hackensack University Medical Center
Date: 11/18/2015
Comment:
The approval of allogeneic transplant for multiple myeloma would give many the oportunity to live as long as they were intended to if they were not afflicted with the disease. We know this type of transplant works, as can be attested by many patients who had this type of transplant and are now cured and able to live normal lives.
Kuriger, Karen Organization: Tate's Salon
Date: 11/18/2015
Comment:
I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy
Piccione-Soultz, Michelle Date: 11/18/2015
Comment:
I am writing in strong support of CMS reconsideration of the current NCD regarding hematopoietic cell transplantation (HCT) for patients with myelofibrosis and sickle cell anemia (SCA). The only hope for most all Myelofibrosis patients is a stem cell transplant. Myelofibrosis is a painful and disabling disease with a terminal prognosis. [PHI Redacted] is currently in a 2 year waiting period for Medicare coverage and has private insurance (COBRA) until then, which covers Stem

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Soultz, Kevin Date: 11/18/2015
Comment:
I am writing in strong support of CMS reconsideration of the current NCD regarding hematopoietic cell transplantation (HCT) for patients with myelofibrosis and sickle cell anemia (SCA). The only hope for most all Myelofibrosis patients is a stem cell transplant. Myelofibrosis is a painful and disabling disease with a terminal prognosis. [PHI Redacted] private insurance (COBRA) until then, which covers Stem Cell Transplants (SCTs). I was shocked to learn that Medicare does not

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ulshafer, karen Date: 11/18/2015
Comment:
Please consider covering SCT for myelofibrosis. It IS the ONLY cure for this terminal disease. Without this option, patients and families will be depressingly discouraged.
Bauman, Ralph Date: 11/18/2015
Comment:
Thank you for helping those suffering from Myelofibrosis. [PHI Redacted] has been fighting this rare blood disease for several years. Please help make it possible for stem cell transplants to be available to ALL who are suffering from all forms of MPN, including Medicare. Thank you!
Negrin, M.D., Robert S. Title: Chief, Division of Blood and Marrow Transplantatio
Organization: Stanford Health Care
Date: 11/18/2015
Comment:

November 18, 2015

Re: CAG-00444R Proposed Decision for SCT

Dear CMS,

The Stanford Blood & Marrow Transplant Program has performed over 5,800 transplants since being founded in 1987. In fiscal year 2015 we performed 359 transplants, of which almost 10% were for patients with Medicare as their primary coverage. As a part of the NCI-designated Stanford Cancer Institute, our program seeks to advance the science of hematopoietic cell transplantation while providing

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Rollston, Karen Date: 11/17/2015
Comment:
Thanks for working to get Medicare coverage for MPN stem cell transplantation. I would like you to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy. [PHI Redacted]
Bruner, Richard Title: Retired
Date: 11/17/2015
Comment:

It was wonderful news the CMS is considering providing Medicare coverage for Myelofibrosis [PHI Redacted] The medicine is losing effectiveness.

I hope and encourage CMS to consider also removing the requirement for concurrent controls in these clinical studies. It would limit a Medicare beneficiary's ability to access this important therapy by not doing so.

Smith, Denise Date: 11/17/2015
Comment:
I realize the CMS has the needs of the public at heart and a very large task at hand. Please consider that the medical service of stem cell replacement can be an important therapy for cancer patients with many different disorders . I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.. Thank you for your help.
Mueller, Dave Date: 11/17/2015
Comment:

Stem cell transplant should be covered under Medicare. [PHI Redacted] It seems to me that this procedure is very successful in Myelofibrosis and new conditioning is opening it up to more patients.

I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.

Turner, Margaret Title: MS
Date: 11/17/2015
Comment:
I am thrilled that CMS is considering providing coverage for Medicare beneficiaries with Myelofibrosis. [PHI Redacted] Stem cell transplant is the only hope for some of these patients [PHI Redacted]. This should be an option for Medicare patients who are at the end of the road without it. Thank you.
Sandomir, Alan Date: 11/17/2015
Comment:
I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis.
I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.
Please do not deny either coverage or the advancement of this medical science. The results can be devastating. The rewards can be profound.
Jean, Caroline Date: 11/17/2015
Comment:
I thank you CMS to look for help in those devasting chronic disease that are really hard to treat and [PHI Redacted] a totally decline in QoL getting it very young. [PHI Redacted] it's really hard also to get support and investment in research as the numbers of patients at very low compare to other cancers.
I hope that you will make sure that the most patient will have access to the studies i.e all MPN patient. As a lot are in their 40's and will have

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Davis, Marty Date: 11/17/2015
Comment:
I applaud the CMS for its efforts to expand coverage for stem cell treatment for Medicare members diagnosed with Myelofibrosis. [PHI Redacted] diagnosed with PV, which has 10-15% likelihood of transitioning into Mylefibrosis. For those who are and will be diagnosed with Myelofibrosis, I implore you to eliminate the concurrent controls in clinical studies because it will restrict access to a critical Myelofibrosis treatment.
Ricci, David Date: 11/17/2015
Comment:
I have MF. I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis. However, I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy. Thank you
David Ricci
Olander, Cynthia Date: 11/17/2015
Comment:
Please make sure ALL ML patients are included in this new study endeavor. Retired folks many of whom served our country, need this coverage to give them a chance for life. To be a grandparent, to contribute through volunteering and supporting their families. Thank you.
Thacher, Stephen Title: COL USA (Ret)
Date: 11/17/2015
Comment:
My comment is provided to ensure that stem cell transplants are an option for ALL MPN patients including someone close to me. I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.
Dyer, Kelly Date: 11/17/2015
Comment:
[PHI Redacted]a Myloproliferative Disorder. PLEASE allow for stem cell transplants to be available to all MPN patients. Thank you.
Chambers, Denise Title: Mrs.
Date: 11/17/2015
Comment:
I would ask that the Centers for Medicare and Medicaid Services revise their proposed study parameters to ensure that the clinical studies make stem cell transplant an option for all MPN patients. [PHI Redacted].
Senyak, Zhenya Title: Publisher
Organization: MPNforum Magazine
Date: 11/17/2015
Comment:
Stem cell transplantation has demonstrated its efficacy clinically and the procedure need not be subjected to the clinical trial process to the detriment of a patient's health. Often timing and the participation of a skilled transplant team as well as MUD is required for a successful ablation, transplant nd recovery. Subjecting a desperately ill MF patient to the rigors of SCT without the assurance of the highest level of professional care -- let alone some double blind designed protocol --

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Klapper, Phillip Title: MD
Date: 11/17/2015
Comment:
I strongly support the proposal to study stem cell transplantation for myelofibrosis since it provides the only known curative treatment. I understand the need for a control group. [PHI Redacted] We need data to define what criteria are needed for SCT selection in addition to age.
Thank you
Frischling, Gary Date: 11/17/2015
Comment:
I appreciate CMS desire to cover AHSCT for myelofibrosis patients. But it seems unduly limiting to restrict coverage to studies having non-transplant controls. It is valuable to patients, and equally valuable as well from the standpoint of developing useful clinical evidence, to support treatment in studies that, for example, compare different transplant protocols.
Anderton, Martin Date: 11/17/2015
Comment:

Please insure that stem cell transplants are available for all MPN patients. The requirements for concurrent controls in these clinical studies can only limit the number of people who can benefit from this therapy.

Thank you,

Marty Anderton
Bromberg, Steven Date: 11/17/2015
Comment:

To the good folks who make decisions re our Medicare coverage. Myelofibrosis is a terrible disease that impacts, for the most part, the elderly. In many instances, the elderly are more so than others, unable to help themselves. There are a very few organizations that are now doing extensive research with the hope of finding a cure, as there is non now and hopefully, at some point, prevention.

I would hope and encourage CMS to consider removing the requirement for concurrent

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Peabody, Celeste Title: Ms
Date: 11/17/2015
Comment:
[PHI Redacted] I really appreciate the content of this action. However, I would appreciate it more if you changed the verbiage to include ALL MPN patients for stem cell transplantation.[PHI Redacted] many times you guys are the front runners that most insurance companies take their cues from.
Thank you for your attention
Celeste M Peabody
Brandi, Jenny Date: 11/17/2015
Comment:
Please allow CMS to cover SCT without the Coverage with Evidence Development (CED) paradigm as described in the proposed decision. There are very few Myelofibrosis (MF) patients so the clinical trial requirement would deny patients a stem-cell transplant that is needed to live! A SCT is important for MF patients and needs to be done in a timely manner for MF patients to be able to survive. Please allow the decision for this to be with the doctor and patient. Thank you.
Bensen, Walt Date: 11/17/2015
Comment:
[PHI Redacted] it is important that this policy for transplant allow for all to have access to SCT/BMT. This disease is one that is relatively unknown to many, including physicians and most likely politicians who do not understand the scope of the disease. Without the option of transplant [patients] face death as there is no other cure. Thank you for your consideration in this important policy.
Steinhart, Nathaniel Date: 11/17/2015
Comment:
[PHI Redacted] Stem Cell Transplant should be available for all MPN patients. This is [the] only option, since there is no other cure. Please provide coverage now. Thank you.
Schafer, Alice Organization: .
Date: 11/17/2015
Comment:
[PHI Redacted]
Please removing the requirement for concurrent controls in the clinical studies for Myelofibrosis, because that will limit Medicare beneficiaries from accessing this valuable therapy.
Midgett, Kathleen Date: 11/17/2015
Comment:
[PHI Redacted] I am very thankful that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis.
Peed, Marina Date: 11/17/2015
Comment:
Please allow CMS to cover SCT without the Coverage with Evidence Development (CED) paradigm as described in the proposed decision. Given the small number of Myelofibrosis (MF) patients covered by CMS, the clinical trial requirements would deny care to patients who could achieve cure from a transplant. There are other ways to meet the objectives of CED with existing clinical and scientific data on MF patients and stem cell transplantation. We know that SCT extends life and quality of life for

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Majhail, Navneet Title: Director, Blood and Marrow Transplant Program
Organization: Cleveland Clinic, Cleveland, OH
Date: 11/17/2015
Comment:
First, I would like to thank CMS for taking on the very important initiative of coverage of stem cell transplantation for multiple myeloma, myelofibrosis and sickle cell disease. Having a mechanism to cover transplant for patients on Medicare/Medicaid will be a critical step in providing appropriate care for patients with these life threatening illnesses. However, I do have signficant concerns about the requirement to include concurrent non-transplant controls as a part of the CED mechanism.

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anctil, pierre Date: 11/17/2015
Comment:
PLEASE be SURE that stem cell transplantation is an option for ALL myelofibrosis patients. I am concerned that some will have more difficulty receiving this life saving treatment
Denny, David Date: 11/17/2015
Comment:
It is important that SCT for Myelofibrosis be covered because it is the only curative treatment. As a chronic disease an SCT might not be required for years, but if a patient waits until they are on Medicare and their disease advances, the lack of coverage is a death warrant. The lack of coverage is inhumane and tends to make one believe in the "death panels" that were said to come with state operated health care.
Anderson, Ron Date: 11/17/2015
Comment:

Thank you for considering including SCT for Myelofibrosis. THis bveneifit is critical to many patients. However, I would like to comment that the requirement to remove the requirement for concurrent controls in these clinical studies. During thecourse of the disease, a patient may suddenly have a significant turn of the disease into actual leukemia. When this condition occurs, there is very little time for the patient and the prognosis is very poor without an SCT. The timing of

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canas, zonia Title: retired Pharmacist
Date: 11/17/2015
Comment:
I am very grateful for CMS trying to provide coverage for Medicare beneficiaries with Myelofibrosis. Thank You.
Woerheide, Gloria Date: 11/17/2015
Comment:

Thank you for considering stem cell transplants for MPN patient. I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.

Thank you.
Joyner, James Date: 11/17/2015
Comment:
I strongly support CMS in its consideration of providing coverage for stem cell transplant for sickle cell disease and myelofibrosis. I also urge CMS to consider providing this life saving therapy to all blood related cancers including all Myeloproliferative Neoplasms (MPN). Omitting MPNs neglects a populace of long suffering patients desperate for a cure, and MPNs often progress to become myelofibrosis.
Scherrer, Lessa Date: 11/17/2015
Comment:

[PHI Redacted] I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with MF. [PHI Redacted] I am concerned that the requirement for concurrent controls in these medical studies will end up limiting the access to this important treatment for Medicare patients [PHI Redacted] As you may or may not know, MF is usually not diagnosed until around the age of 60, so it hits older patients disproportionately. This makes it

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Heise, Lisa Title: Mrs.
Date: 11/17/2015
Comment:
[PHI Redacted] There are a lot of people living with this and don't have enough insurance to cover cancer treatment let alone the transplant which could potentially save lives.
Boyce, John Date: 11/17/2015
Comment:
I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis but [PHI Redacted] I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.
Max, Jean Date: 11/17/2015
Comment:
I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis, but I hope you will ensure that stem cell transplants are an option for ALL MPN patients.
Selover, Kathy Date: 11/17/2015
Comment:
[PHI Redacted] I strongly urge CMS to reconsider the limitations placed on coverage of SCT for myelofibrosis patients. Myelofibrosis is an end stage disease and for some, an SCT is the only treatment. Requiring the patient to delay SCT until AML transformation is cruel treatment.
ELLIOTT, FRANCEY Title: MRS
Organization: Homemaker
Date: 11/17/2015
Comment:
  • I am grateful, [PHI Redacted] that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis.
  • I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy. [PHI Redacted] I believe any such concurrent controls will hamper hopes as well as the hopes of many others.
  • Thank you for

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    Reekie, Linda Date: 11/17/2015
    Comment:
    Medicare should be aware that Myelofibrosis is largely a disease of older patients who could greatly benefit from the opportunity to have a SCT. The procedure is not as rigorous as a BMT.
    Myrick, Cindia Date: 11/17/2015
    Comment:
    Please help us by making stem cell transplantation available for all MPN patients. [PHI Redacted]
    Broxmeyer, Marc Date: 11/17/2015
    Comment:
    I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Myelofibrosis.
    I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.
    eastin, gary Date: 11/17/2015
    Comment:
    I appreciate your willingness to pay for transplants where Myeloproliferative diseases are concerned. Please consider paying for transplants where necessary regardless of whether a clinical trial is involved. Many diseased individuals will not be accepted for trial and those people will die without transplant. Thank you for your consideration.
    cohn, jeffrey Date: 11/17/2015
    Comment:
    thank you very much for helping patients receive coverage for Medicaire beneficiaries for myelofibrosis. Please try your best to remove the requirements for concurrent controls in clinical studies. It will undoubtedly limit the ability of some patients to receive this important therapy, and it's all the hope they really have to survive.
    Fatone, Pamela J Date: 11/17/2015
    Comment:

    Myelofibrosis is a rare and incurable disease. The only option and not all MF patients qualify, is a Bone Marrow or Stem Cell Transplant. [PHI Redacted] was young when diagnoised with PMF, Primary Myelofibrosis...49. At the age of 53 He had his Stem Cell transplant at Memorial Sloan Kettering.... It saved his life! There is no PILL to cure MF only pills to mask symptoms. Please DO NOT take away The ONLY option, available to some of the MF population. How could you?

    Zuriff, Leonard Date: 11/17/2015
    Comment:
    Hi - thank you for this opportunity to comment. I hope the committee will consider to ensure that stem cell transplants are an option for ALL MPN patients. Thank you.
    Prosnitz, David Organization: Personnel Planners
    Date: 11/17/2015
    Comment:

    I appreciate that CMS is looking to provide coverage for Myelofibrosis.

    Please consider removing the requirement for concurrent controls in these clinical studies because it will limit a Medicare beneficiary's ability to access this important therapy.

    Street, Kathy Date: 11/17/2015
    Comment:
    Please revise the proposed study parameters to ensure that the clinical studies make stem cell transplant an option for all MPN patients.
    Ariel, Amy Organization: Ms.
    Date: 11/17/2015
    Comment:

    [PHI Redacted] I fully support expanded coverage, but urge the Agency to find a reasonable way to conduct the research. It is not fair for some patients to be told that they cannot access a life-saving transplant while other patients can access them simply to evaluate the efficacy of the transplant, when there is clear evidence in younger groups of people of its success and we know the outcome of not obtaining a transplant.

    I'm asking you to provide access to all

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    Simms, William Date: 11/17/2015
    Comment:
    Please strongly consider the life saving aspects of this coverage. [PHI Redacted] I advocate for others are not as fortunate but should be afforded life saving medical advances.
    Lowrey, Christopher Title: Professor of Medicine and Chief of Hematology
    Organization: Geisel School of Medicine at Dartmouth
    Date: 11/17/2015
    Comment:

    Dear CMS,

    I am writing to comment on the recently announced Proposed Decision Memo for Stem Cell Transplantation (Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease). As a hematologist with more than 25 years of transplant experience who trained at the NIH, I welcome your goal of better characterizing the risk and benefits associated with allogeneic transplantation for these three diseases. Based on quite extensive literature and my experience, I believe there is good

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    McCarthy, Philip Title: MD
    Organization: Roswell Park Cancer Institute
    Date: 11/17/2015
    Comment:
    I am writing to support CMS coverage for allogeneic hematopoietic stem cell transplant (alloHCT) for multiple myeloma, myelofibrosis and sickle cell disease. AlloHCT is a potentially curative option for selected patients with these life-threatening diseases. Not all of these patients should undergo an alloHCT. There are risk stratifications and treatment guidelines for high risk multiple myeloma, myelofibrosis and sickle cell disease. This allows for the appropriate selection of high risk

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    Metheny, Leland Title: MD
    Organization: University Hospitals, Case Medical Center
    Date: 11/17/2015
    Comment:
    Stem Cell Transplant for Myelofibrosis should be covered for medicare and mediaid patients. In patients with high risk disease, it has a very high likelihood of transforming into acute leukemia; if medicare and medicaid cover transplant for MF, physicians can potentially cure MF before transforming into acute leukemia. This may result in improved outcomes as well as cost saving.
    Johnson, Shelby Date: 11/17/2015
    Comment:
    This decision on Medicare coverage for HCT would potentially decrease access to HCT for some patients.
    michael, kathleen Date: 11/16/2015
    Comment:
    Please allow Medicare coverage for stem cell transplants in clinical trials to apply all MF patients.
    Griffiths, Robert Date: 11/16/2015
    Comment:

    [PHI Redacted] This is the only potential cure for this disease . I think this should be covered if the individual has a good match and is strong enough to make it thru.

    Schriber, Jeff Title: Medical Director
    Organization: Cancer Transplant Institute
    Date: 11/15/2015
    Comment:

    I would like to first commend CMS for looking to extend the coverage for MM, MPS and sickle cell. Each of these has substantial data that suggests benefit in appropriate patients. Frequently however this potentially curative option is limited due to lack of coverage. At our center we see a significant amount of MF who are transplanted. For patients with MM, we like most centers typically perform an autologous transplant however for younger patients or those who may have already failed an

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    Prager, Martin Organization: None
    Date: 11/15/2015
    Comment:
    I am a layman that has observed individuals with myelofibrosis (MF). MF is an older person's disease frequently affecting those of Medicare or Medicaid age. Individuals with MF suffer from a number of very serious chronic and acute medical conditions as a result. MF adversely affects their quality of life including the inability of work and/or simply lead a normal life. Some people with MF respond to the few available drugs or other therapies but all MF patients not treated with

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    Forzani, Mary Date: 11/15/2015
    Comment:
    Thank you for addressing the need to allow Medicare coverage for stem cell transplants for myelofibrosis patients. [PHI Redacted] Please ensure that the clinical studies make stem cell transplant an option for all who suffer from myelo proliferative neoplasms including essential thrombocytosis, polycythemia vera, and myelofibrosis. Thank you.
    Meyers, Nancy Title: Mrs
    Organization: MPN Foundation
    Date: 11/15/2015
    Comment:
    I'm delighted that CMS is addressing the need for SCT for mylofibrosis patients. We need to realize that this disease is extremely rare, and any limits to the patients participation may impact the research to make this treatment more viable for a very small group of patients. [PHI Redacted] Thank you for making this forum part of your decision.
    MacCollum, Lisa Date: 11/15/2015
    Comment:

    I ask that you remove the concurrent non-­-HCT control requirements as part of the proposed rule for Medicare coverage of HCT.

    [PHI Redacted] I believe that we need access to quality care and all treatment options without restrictions.

    Thank you for your kind consideration.

    Dreyfuss, Zoia Date: 11/14/2015
    Comment:

    Stem Cell Transplant is the only potentially curative therapy for Myelofibrosis. SCT has proven effective at extending patient life and even eradicating disease. In the case of Myelofibrosis, patients both over and under 65 have benefited significantly from transplants. For Medicare to deny transplant coverage for MF robs a significant cohort of patients of their only chance of survival. In addition, MF often progresses to Acute Myeloid Leukemia, a disease which carries an even worse

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    moorehead, maryellen Title: Stem Cell coverage for MF for Medicare Patients
    Date: 11/14/2015
    Comment:

    Thank you for addressing the need for medical coverage for those MF patients who, along with their medical team, choose Stem Cell Transplant as their best option for treatment. [PHI Redacted] Please vote to allow full coverage for MF.

    Stern, Karen Date: 11/13/2015
    Comment:

    Please consider making stem cell transplants available for Medicare patients for those with Myelofibrosis! It is the only hope that we have for a cure for this disease.

    Thank you

    Selinger, Howard Title: Chairman Dept. Family Medicine
    Organization: Frank H. Netter MD School of Medicine Quinnipiac University
    Date: 11/13/2015
    Comment:
    Often, for many, stem cell transplantion is a last resort as a potential life saving measure for terminal bone marrow disease. Please don't do anything that would limit this opportunity, when clinically indicated.
    Simon, Jeffrey Organization: Dr.
    Date: 11/13/2015
    Comment:
    I believe it would be best to allow Stem Cell Transplantation for all forms of MPN's
    Williams, Gratia Date: 11/13/2015
    Comment:

    Concerning MYELOMA ONLY. I am very pleased that CMS is reviewing the NCD for allogeneic transplants for myeloma patients. I began this advocacy on behalf of [PHI Redacted] who is a myeloma patient. It is imperative for CMS officials to consider carefully the issues of concern submitted by transplant physicians, hematologists, the National Marrow Donor Program and other stakeholders regarding, in particular, the requirement for "concurrent non-HCT controls" which will

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    McKiernan, Phyllis Title: APN
    Organization: Hackensack University Medical Center
    Date: 11/12/2015
    Comment:

    I understand that CMS is trying to provide coverage for Medicare beneficiaries with Sickle Cell, Myelofibrosis, and Multiple Myeloma. I am so pleased for this consideration.

    I am a Nurse Practitioner at Hackensack University Medical Center in NJ. We treat patients with these diseases and want to be able to offer transplantation as a treatment option for their disease. The literature shows transplant is a reasonable option for these patients and can offer cure or long-term

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    Burns, Linda Title: MD
    Organization: National Marrow Donor Program
    Date: 11/12/2015
    Comment:
    I am strongly in favor of CMS providing coverage for allogeneic SCT for these conditions, and would urge CMS to not require enrollment only through a study with a control, non-SCT, group. I am concerned that such a requirement will decrease access to SCT for patients desperately in need. I was a transplant physician for over 25 years and daily saw patients in need who had no coverage. While I applaud these first steps, I hope you will consider an alternative pathway to coverage for allo HCT.
    Fowler, Daniel Title: National Institutes of Health
    Organization: National Cancer Institute
    Date: 11/12/2015
    Comment:
    Recent advances in allogeneic transplant have increased the safety of this potentially curative therapy of multiple myeloma. The graft-versus-myeloma effect clearly exists, but the key to harnessing this effect is to deliver the transplant more safely. If this can be accomplished, the quality of life and increased survival of myeloma patients can be achieved. As stated in your proposal, it is important to collect as much data as possible on the CMS patients who receive allogeneic transplant

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    Bajwa, Rajinder Title: MD
    Date: 11/12/2015
    Comment:
    As a transplant physician we are offering transplants to patients with Sickle cell disease and will like to continue this procedure for the patients with sickle cell disease.
    Terpening, Michael Title: CIO
    Organization: Case Management International
    Date: 11/12/2015
    Comment:
    [PHI Redacted] I do not think it appropriate to require a control group study on transplants of this nature as it will essentially withold life saving treatments.
    As a health care outcomes analyst, I also think that an effective non-control based study can be developed to evaluate efficacy of the transplant process for the conditions under consideration WITHOUT withholding treatment to a control group. That would be a more humane way with the same results in

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    chao, nelson Title: MD
    Organization: duke university
    Date: 11/12/2015
    Comment:
    My thanks to CMS for the effort to provide coverage for multiple myeloma, myelofibrosis and sickle cell disease. I am a physician and researcher and the chief of the division of hematological malignancies and stem cell transplantation at Duke University. I urge CMS to consider removing the requirements for concurrent controls in these clinical studies because it will prevent Medicare beneficiaries from benefiting from this important life saving approach. Many of these patient can be cured with

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    Brazeau, Ann Title: CEO and Founder
    Organization: MPN Advocacy & Education Int'l
    Date: 11/12/2015
    Comment:

    November 12, 2015

    Centers for Medicaid and Medicare Services
    Department of Health and Human Services

    To Whom It May Concern:

    We applaud the Centers for Medicaid and Medicare Services (CMS) for addressing the need to provide Medicare coverage for transplants through approved clinical trials. However, we believe the concurrent non-HCT control requirements would actually impede a patient's ability to participate rather than improve their options for

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    Rao, Sridhar Title: Associate Investigator
    Organization: BloodCenter of Wisconsin
    Date: 11/11/2015
    Comment:
    Current barriers to coverage prevent bone marrow transplant physicians, such as myself, from providing possible curative approaches to patient with debilitating chronic medical conditions such as Sickle Cell Anemia. Given recent advances in stem cell therapies, we should be working at improving patient's lives, and not at restricting their access to high quality care.
    Steuer, Patricia Date: 11/11/2015
    Comment:
    Regarding CAG-00444R Proposed Decision for SCT:
    [PHI Redacted] I am writing to encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it will limit Medicare beneficiary's ability to access this important therapy.
    Please revise CMS proposed study parameters to ensure that the clinical studies are accessible to patients seeking transplant. I ask this for [PHI Redacted] and for many patients who

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    Snyder, David Title: Associate Direcotr, Department of Hematology/HCT
    Organization: City of Hope Cancer Center
    Date: 11/11/2015
    Comment:
    I treat many patients with myelofibrosis. Most of these patients are in the age range of 50-75 years. The only potentially curative option available for them is an allogeneic stem cell transplant. At our institution, we have an overall survival rate of 71% over the last 6 years. It is imperative that Medicare patients be given the opportunity to benefit from this treatment modality. We have standard protocols in place for long term follow up of all transplant survivors, in addition to the

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    Mahadeo, Kris Title: MD Director of Pediatric BMT
    Organization: Children's Hospital at Montefiore
    Date: 11/11/2015
    Comment:

    As the Director of Pediatric BMT at center committed to working with patients affected by Sicle Cell Disease, I am deeply concerned about the proposal that before CMS will pay for a transplant in sickle cell disease, the health care providers would be required to have a control group that was developed at the same time.

    Those of us who have worked with patients and families afflicted with this disease, have seen first hand the natural evolution of this disease without curative

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    Sprague, Kellie Title: Director, Bone Marrow and Stem Cell Program
    Organization: Tufts Medical Center
    Date: 11/11/2015
    Comment:

    I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with [Sickle Cell, Myelofibrosis, and Multiple Myeloma].

    I am a bone marrow transplant physician and clinical researcher at Tufts Medical Center in Boston. Our center treats patients with these diseases and want to be able to offer transplantation as a treatment option for their disease. I encourage CMS to consider removing the requirement for concurrent controls in these clinical studies because it

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    Pergam, Steven Title: MD, MPH
    Organization: Fred Hutchinson Cancer Research Center
    Date: 11/11/2015
    Comment:

    I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with Sickle Cell disease, Myelofibrosis, and Multiple Myeloma. But I have some concerns about options that may be curtailed with the current wording of these documents.

    I am concerned that the current recommendations will limit access to hematopoietic cell transplantation - a life-saving and potentially curative treatment for these conditions. I encourage CMS to consider removing the requirement for

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    Watters, Amber Date: 11/11/2015
    Comment:
    I appreciate that CMS is trying to provide coverage for Medicare beneficiaries with [Sickle Cell, Myelofibrosis, Multiple Myeloma]. This initiative is very important to improve the health and quality of life for patients with these disorders.
    Sieger, Emily Date: 11/10/2015
    Comment:

    [PHI Redacted] with Primary Myelofibrosis. At this point in time, and for the foreseeable future, SCT is the ONLY cure. I applaud your consideration of Medicare coverage for this procedure. However, the requirement that Medicare will pay for an SCT only if the patient is part of a clinical trial will rule out the vast majority of potential candidates for this life saving procedure. Rural patients in particular can rarely participate in clinical trials because of the

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    Sutton, Lindy Date: 11/10/2015
    Comment:
    I support CMS in their effort to possibly cover Stem Cell Transplantation for Myelofibrosis. It is the last choice for a cure for those with Myelofibrosis. After all medications have been tried to no avail the patient will likely die without the option of a cure with a stem cell transplant. Most patients are not diagnosed until their 60's therefore it is an important option for patients that may be on Medicare at the time of diagnosis.
    Sanchez-Vinson, Angelina Title: social worker
    Organization: KU Cancer Center
    Date: 11/10/2015
    Comment:
    I am in support of the CMS proposal for coverage for allogeneic hematopoietic cell transplant (HCT), for patients with Multiple Myeloma, Sickle Cell Disease or Myelofibrosis. Please revise the study parameters to ensure that the clinical studies are accessible to patients seeking transplant by removing the requirement for concurrent non-HCT controls. Medicare/Medicaid patients should have access to this life-saving treatment.
    Chernov, Allan Title: M.D.
    Organization: Blue Cross Blue Shield of Texas
    Date: 11/10/2015
    Comment:

    I am requesting that CMS include consideration of Health Care Service Corporation (HCSC) medical policy coverage positions in its review of public comments on proposed coverage of the three relatively rare conditions referenced above.

    HCSC, a Mutual Legal Reserve Company, has 15+ million members in 5 Blue Cross Blue Shield (BCBS) plans (TX, IL, OK, NM, MT) that are Independent Licensees of the Blue Cross and Blue Shield Association.

    HCSC has conditional coverage of

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    Steagall, Jodi Date: 11/10/2015
    Comment:

    Myleofibrosis stem cell transplant should be allowed without major restrictions if patients QOL is significantly affected and they're unable to work due to disease symptoms. Why would you want patients to suffer with symptoms and poor QOL especially of they're diagnosed much younger than the standard 60? Why make them feel like a constant burden to society because they are no longer able to work? Besides medical statistic data in your decision making process where's the human data? Do you

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    Thompson, Trevor Title: CEO
    Organization: Sickle Cell Foundation of Tennessee
    Date: 11/09/2015
    Comment:

    Dear CMS:

    As a CEO of Sickle Cell Disease Association of Tennessee [PHI Redacted], I am deeply concerned about the proposed edict that before CMS would pay for a transplant in sickle cell disease, the investigators would be required to have a control group that was developed at the same time. We have multiple individuals in our community based organization that have received a bone marrow transplant and have provided counseling and services before and after a

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    Abraham, Allistair Date: 11/09/2015
    Comment:

    To whom it may concern:

    I think it is very commendable that the CMS staff have taken significant time and effort to address the lack of coverage for Sickle Cell Disease and curative bone marrow transplantation. Allowing coverage to participate in a trial with transplant and control patients is quite attractive and in theory should answer questions about the benefit adults with sickle cell disease undergoing transplantation get compared to those who do not. Setting up such studies

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    Walters, Mark Title: Director, BMT program
    Organization: UCSF Benioff Children's Hosp, Oakland
    Date: 11/05/2015
    Comment:

    The proposal to limit CMS-approved coverage for stem cell transplantation in sickle cell disease to participants in prospective clinical trials that include concurrent non-transplant controls will effectively constrain access to this curative therapy. There is comprehensive and compelling evidence of a clinical benefit of transplantation in recipients of all ages who have severe disease manifestations. A sickle cell disease clinical trial comparing transplant and non-transplant concurrent

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    Westervelt, Peter Title: Professor of Medicine
    Organization: Washington University
    Date: 11/05/2015
    Comment:

    The Centers for Medicare and Medicaid Services (CMS) has proposed Medicare coverage for allogeneic hematopoietic cell transplant (HCT) for patients with three indications: (Multiple Myeloma, Sickle Cell Disease and Myelofibrosis), provided they participate in an approved clinical trial, similar to current HCT coverage for patients with MDS. However, as proposed, concurrent non-HCT controls are problematic for the following reasons:

    Requiring concurrent non-HCT controls which will

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    Parmelee, Brennan Title: RN Stem Cell Transplant Coordinator
    Date: 11/05/2015
    Comment:

    Please reconsider the requirement of concurrent non-HCT controls when conducting these trials. There is much evidence already which supports the notion that survival of these diseases is not conducive without a transplant (ie: a new immune system) because their current immune system has failed. In the case of SCD, the patient is doomed to live a life full of pain, complications, limitations and numerous set-backs that impact personal growth and development, economic flourish, education,

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    Flynn, Rose Title: Sr. Stem Cell Data Specialist
    Organization: Yale New Haven Hospital
    Date: 11/04/2015
    Comment:

    Although I do appreciate Medicare's requirements regarding the study process for the above three disease catagories, I would just like to remind the study investigators that "one size does not fit all." Having a diagnosis of any cancer is devastating, however Multiple Myeloma, Myelofibrosis & Sickle Cell Disease are exceptionally dreadful in that the current "standards of care" are only temporary fixes and we need to find something else that may very well offer these patients hope for cure

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    Xiong, Serena Organization: University of California Davis
    Date: 11/04/2015
    Comment:
    Allogeneic stem cell transplant is medically necessary for Multiple Myeloma, Sickle Cell Disease and Myelofibrosis. We recently had a patient with one of the fore mentioned diseases in need of allogeneic transplant and his treatment was delayed because we had to appeal to the secondary plan to cover the transplant as the primary coverage. This patient's plan fortunately approved the service but overall effected his survival rate.
    Colt, Loretta Date: 11/04/2015
    Comment:
    CAG-00444R Proposed Decision for SCT - Please continue funding research for these diseases through Medicare. Not only is it critical for these patients but it also sets a precedent for discontinuation of funding for other HCT related procedures in the future.
    Antin, Joseph Title: Chief Stem Cell Transplantation
    Organization: Dana-Farber Cancer Institute
    Date: 11/04/2015
    Comment:

    I am delighted that CMS is providing coverage for these 3 important diseases, I am concerned about the requirement for concomitant controls. In my view it is almost impossible to obtain valid control populations since few patients will be willing to be randomized. This is made particularly acute by a change in transplant practice in the last few years. Previously we can do a donor/no donor analysis which allowed us to use patients without histocompatible donors as suitable controls. While

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    Lewis, Howard Date: 11/04/2015
    Comment:
    Medicare coverage for MF well may be a life saver for [PHI Redacted]. I wish it was not restricted to a clinical trial environment.
    Jones, Richard Title: Professor, Director of BMT Program
    Organization: Johns Hopkins University
    Date: 11/02/2015
    Comment:

    At Johns Hopkins, we only perform allogeneic blood or marrow transplantation (alloBMT) for myeloma, myelofibrosis, and sickle cell anemia on prospective clinical trials aimed at improving outcomes. We have worked closely with our local CMS carrier concerning our alloBMT clinical trials in sickle cell anemia and myelofibrosis, diseases on which CMS has been “silent” regarding coverage for alloBMT. Based on these interactions, the local carrier has chosen to cover alloBMT trials in these

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    Goldworm, Sandra Date: 10/30/2015
    Comment:

    I have read your decision regarding myelofibrosis transplants.
    I do not follow your logic. If myelofibrosis morphs into AML,it is. covered. At that point the patient is very sick and chances of a good outcome are low.
    I am thankful that you pay about $240,000a year for Jakafi and Thalomid. tHese drugs arenot a cure and it is money not well spent. Why not spend a $500,000fora transplant thAt would give [PHI Redacted] His life back? iF docs feel this is viable,

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    goldworm, geoffrey Title: vmd
    Date: 10/30/2015
    Comment:
    I question the logic that medicare Part D pays over $200,000 a year to keep [PHI Redacted] on medications that relief the symptoms of myelofibrosis (Jakafi and Thalomid) but are not a cure. But Medicare will not cover a SCT (BMT) which is the only possible cure for the disease including its new decision of 10/29/15