National Coverage Analysis (NCA) Tracking Sheet for Stem Cell Transplantation (Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease) (CAG-00444R)

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Issue

Stem cell transplantation is a process in which hematopoietic stem cells are harvested from the bone marrow or peripheral blood of a patient (autologous) or a donor (allogeneic) and then administered by intravenous infusion. Hematopoietic stem cells are multi-potent stem cells that give rise to all the blood cell types; these stem cells form blood and immune cells. Autologous stem cell transplants are used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy and/or radiotherapy used to treat various malignancies. Allogeneic stem cell transplants may be used to restore function in recipients having an inherited or acquired deficiency or defect.

The NCD (110.8.1) for Stem Cell Transplantation provides covered and non-covered clinical indications.

The requestor is formally asking CMS for reconsideration and expansion of the current NCD.

This NCA will only evaluate the available evidence to determine whether a national coverage determination is warranted for

allogeneic stem cell transplantation in patients with sickle cell disease,
allogeneic stem cell transplantation in patients with myelofibrosis, and
allogeneic stem cell transplantation in patients with multiple myeloma.

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and that address the breadth of the request.

CMS is reorganizing the National Coverage Determination manual for section 110.8.1. This reorganization is an administrative change only to make it easier for the public to read and understand the NCD manual.

Benefit Category

No Benefit Category

Requestor Information

Requestor Name(s): Sergio Giralt, MD, President, American Society for Blood and Marrow Transplantation; Michael Boo, JD, Chief Strategy Officer, National Marrow Donor Program

Requestor Letter(s): View Letter

Important Dates

Formal Request Accepted and Review Initiated: 04/30/2015

Expected NCA Completion Date: 01/27/2016

Public Comment Period: 04/30/2015 - 05/30/2015

Proposed Decision Memo Released: 10/29/2015

Proposed Decision Memo Public Comment Period: 10/29/2015 - 11/28/2015

Decision Memo Released: 01/27/2016

Comments for this NCA: View Public Comments

Contacts

Lead Analyst(s):

Cheryl Gilbreath, PharmD, MBA, R.Ph.

Lead Medical Officer(s):

Lori Paserchia, MD

Actions Taken

April 30, 2015

CMS opens this NCA for Stem Cell Transplantation (Sickle Cell Disease and Myelofibrosis). The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.

Instructions on submitting comments can be found at: http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html

To submit a comment, please use the orange "Comment" button at the top of the page. Enter comments directly into the "Submit A Public Comment" webpage.

October 29, 2015

Posted proposed decision memo for Stem Cell Transplantation (Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease). CMS added multiple myeloma to this NCA.

January 27, 2016

Posted final decision memo.

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