National Coverage Analysis (NCA) View Public Comments

Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers

Public Comments

Commenter Comment Information
Dickson, Dane Title: Chief Executive Officer
Organization: Taproot Health
Date: 03/17/2019
Comment:

March 15, 2019

Tamara Syrek Jensen, J.D.
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

RE: Medicare National Coverage Analysis for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancer (CAG-00451N)

Dear Ms. Jensen and CAG Team:

I applaud the decision to cover CAR-T therapy and the language in which the coverage decision is crafted,

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Allen, Jeff Title: President & CEO
Date: 03/17/2019
Comment:

Jeff Allen, PhD
1800 M Street NW
Suite 1050 South
Washington, DC 20036

March 17, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms.

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Amoroso, Michael Title: Senior Vice President and Head of Worldwide Commer
Organization: Kite Pharma
Date: 03/17/2019
Comment:

SUBMITTED ELECTRONICALLY

March 15, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Determination for Chimeric Antigen Receptor (CAR) T-cell therapy for Cancers (CAG-0045IN)

Dear Ms. Syrek Jensen:

Kite Pharma (Kite), a Gilead Company, appreciates the opportunity

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Anonymous, Anonymous Title: N/A
Organization: N/A
Date: 03/17/2019
Comment:

March 15, 2019

Ms. Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: National Coverage Analysis (NCA) for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen,

I am writing to urge CMS to finalize the NCD without CED, since the CED creates an

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Klein, Andreas Title: Associate Chief, Hematology/Oncology
Organization: Tufts Medical Center
Date: 03/17/2019
Comment:
Thank you for the opportunity to comment. CMS is commended for efforts to increase access to life-saving CAR-T therapy to lymphoma patients in critical need of new therapies. A decision to cover must be matched by a commitment to cover the full costs of care for both inpatient and outpatient care in order to assure access for all Medicare patients. Qualifications proposed for participating centers places appropriate emphasis on capability, but should be more explicit in how such

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Carlson, Jennifer Title: Associate Vice President For External Relations
Organization: The OSU James Cancer Hospital and Solove Research Institute
Date: 03/17/2019
Comment:

March 15, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen,

The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital

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Phillips, Steve Title: Senior Director
Organization: Johnson & Johnson
Date: 03/17/2019
Comment:

March 17, 2019

Katherine B. Szarama, PhD
Lead Analyst
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Blvd.
Baltimore, MD 21244

Re: Proposed Decision Memo (PDM) for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Dr. Szarama:

Johnson & Johnson (“J&J”) is pleased to submit comments on the referenced

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N/A, N/A Organization: Biotechnology Innovation Organization
Date: 03/17/2019
Comment:

March 17, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Cc: Katherine B. Szarama, Ph.D., Lead Analyst ; Lori A. Paserchia, MD, Lead Medical Officer

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-Cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen,

We the undersigned organizations are writing in

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White, Claire Organization: Children’s Hospital of Philadelphia
Date: 03/17/2019
Comment:

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Ms. Jensen,

We appreciate the opportunity to provide feedback as the Centers for Medicare and Medicaid Services finalize the National Coverage Decision for Chimeric Antigen Receptor T-Cell Therapies. We acknowledge the complicated nature of these therapies

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Miller, Peter Title: Medical Doctor
Organization: Wake Forest School of Medicine
Date: 03/17/2019
Comment:
I strongly recommend for CMS to consider the absolute novel nature of CAR-T and similar therapies. These therapies have the high likelihood to be the wave of future cancer care and management. These therapies also require extensive multi-specialty expertise for some of the most complex patients. While these therapies are new and side-effects are attempting to be minimized, it is very clear that CAR-T is not an outpatient procedure. Although the therapy is giving hope to populations that had a

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Levy, Robin Title: Senior Director of Public Policy and Advocacy
Organization: International Myeloma Foundation
Date: 03/17/2019
Comment:

March 17, 2019

Lori A. Paserchia, MD
Lead Medical Officer
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Katherine B. Szarama, PhD
Lead Analyst
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Drs. Paserchia

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Pardee, Timothy Title: Associate Professor
Organization: Wake Forest Baptist Health
Date: 03/17/2019
Comment:

I would like to submit the following:

  • It is premature for CMS to implement a national coverage decision (NCD) due to the rapidly evolving nature of the science. CMS should hold on making a coverage decision until the field matures.
  • However, if CMS does finalize the NCD, we request the a NCD with registry reporting requirement without a CED. A CED may prompt some institutions to "opt out" further limiting access to Medicare beneficiaries.
  • Recognize the

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GORDAN, LUCIO Title: Dr.
Organization: Florida Cancer Specialists
Date: 03/17/2019
Comment:

The Honorable Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CAG-00451N
P.O. Box 8013
Baltimore, MD 21244-8013

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers; CAG-00451N

Dear Administrator Verma:

I am writing this communication on behalf of Florida Cancer Specialists in reference to the Proposed Decision Memo for Chimeric

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Verb, Katie Title: Director
Organization: PhRMA
Date: 03/17/2019
Comment:

March 17, 2019

VIA electronic delivery

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: Proposed National Coverage Determination for Chimeric Antigen Receptor (CAR) T-Cell Therapy for Cancers (CAG-00451N)

Dear Director Jensen:

The Pharmaceutical Research and Manufacturers of America (PhRMA) appreciates this

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Howard, Dianna Title: Director, Stem Cell Transplant and Cell Therapy
Organization: Wake Forest Baptist Comprehensive Cancer Center
Date: 03/17/2019
Comment:

As the director of the Stem Cell Transplant and Cell Therapy Program at Wake Forest Comprehensive Cancer Center I am writing to echo the recommendations of ASTCT with regard to CMS policy statement in regard to CAR T-cell Therapy for cancer. At Wake Forest we have an extensive catchment area that encompasses parts of 4 states. Our patients include an underserved Appalachian population already facing extreme challenges with access to specialized healthcare. CAR T-cell therapy is

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Franklin, Elizabeth Title: Executive Director, Cancer Policy Institute
Organization: Cancer Support Community
Date: 03/17/2019
Comment:

March 17, 2019

Seema Verma
Administrator
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
P.O. Box 8013
Baltimore, MD 21244-8013

Tamar Syrek Jensen
Director
Evidence and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Boulevard
S3-02-01
Baltimore, MD 21244

Re: Proposed Decision Memo for Chimeric Antigen Receptor

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Muller, Ralph Title: CEO
Organization: University of Pennsylvania Health System (Penn Medicine)
Date: 03/17/2019
Comment:

Seema Verma
Administrator
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
P.O. Box 8011
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Administrator Verma:

On behalf of the University of Pennsylvania Health System (UPHS), we appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) Proposed

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Walker, David Organization: Spectrum Health
Date: 03/17/2019
Comment:

March 15, 2019

Tamara Syrek Jensen, JD
Director, Evidence and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Via Electronic Submission

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen:

Spectrum Health appreciates the opportunity to provide comments on the Centers

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Bens, Cynthia Title: Senior Vice President, Public Policy
Organization: Personalized Medicine Coalition
Date: 03/17/2019
Comment:

March 17, 2019

Tamara Syrek Jensen, J.D.
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

Sent electronically

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancer (CAG-00451N)

Dear Ms. Syrek Jensen:

The Personalized Medicine Coalition (PMC), a multi-stakeholder group comprising more than 230

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Alvarnas, Joseph Title: Vice-President of Government Affairs
Organization: City of Hope
Date: 03/17/2019
Comment:

As the President for Strategy and Business Ventures and Vice President of Government Affairs at The City of Hope National Medical Center, we welcome the opportunity to submit comments on behalf of our institution regarding the Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451-N). City of Hope is a national leader in cancer care and is the only institution in the United States whose blood and marrow transplant program has produced allogeneic

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Foss-Campbell, Betsy Title: Senior Manager of Advocacy and Outreach
Organization: American Society of Gene & Cell Therapy
Date: 03/17/2019
Comment:

March 17, 2019

Tamara Syrek Jensen, JD, Director
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Katherine B. Szarama, PhD, Lead Analyst
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Lori A. Paserchia, MD, Lead Medical Officer
Evidence and Analysis Group
Centers for Medicare &

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Stewart, Christopher T. Title: Associate Vice President Public Policy
Organization: Humana
Date: 03/17/2019
Comment:

Tamara Syrek Jensen, J.D., Director
Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Katherine B. Szarama, Ph.D., Lead Analyst
Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Lori A. Paserchia, M.D., Lead Medical

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May, Donald Title: Executive Vice President
Organization: The Advanced Medical Technology Association (AdvaMed)
Date: 03/17/2019
Comment:

March 18, 2019

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mailstop S3-02-01
7500 Security Blvd.
Baltimore MD 21244

RE: Proposed National Coverage Determination for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen:

The Advanced Medical Technology Association (AdvaMed) offers the

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Wahidi, Momen Title: Chief Medical Officer, PRMO Duke Heath
Organization: Duke University Health System
Date: 03/16/2019
Comment:

March 14, 2019

Tamara Syrek Jensen, Director
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Katherine B. Szarama, PhD, Lead Analyst
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Lori A. Paserchia, MD, Lead Medical Officer
Evidence and Analysis Group
Centers for Medicare & Medicaid

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Kuntz, Crystal Title: Vice President, Healthcare Policy & Research
Organization: Biotechnology Innovation Organization
Date: 03/16/2019
Comment:

Submitted Electronically

March 16, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Cc: Katherine B. Szarama, Ph.D., Lead Analyst; Lori A. Paserchia, MD, Lead Medical Officer

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-Cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek

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Gutierrez, Meghan Date: 03/16/2019
Comment:

March 16, 2019

Ms. Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
Room 445-G
200 Independence Avenue, NW
Washington, DC 20201

Tamara Syrek Jensen
Director
Evidence and Analysis Group

Katherine B. Szarama, PhD
Lead Analyst
Evidence and Analysis Group

Lori A. Paserchia, MD
Lead Medical Officer
Evidence and Analysis

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Rinker, Terri Title: Chair person
Organization: Provider Round Table
Date: 03/16/2019
Comment:

The Provider Roundtable is pleased to submit comments on the Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N). The Provider Roundtable (PRT) is a forum for hospital professionals to collaborate on and communicate about health care regulatory issues that are critical to their organizations. The PRT includes representatives from 14 different health systems, serving patients in 18 states. PRT members are employees of hospitals and, as such, we

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Battaglini, Mark Title: Vice President Global Govn't Affairs Public Policy
Organization: bluebird bio
Date: 03/16/2019
Comment:

March 16, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen:

On behalf of bluebird bio, Inc. (“bluebird”), we appreciate the opportunity to submit comments in response to the Centers for Medicare

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Rice, Brent Title: Vice President, Global Market Access
Organization: Autolus Therapeutics plc
Date: 03/16/2019
Comment:

March 16, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Determination for Chimeric Antigen Receptor (CAR) T-cell therapy for Cancers

Dear Ms. Syrek Jensen:

Autolus Therapeutics plc (“Autolus”) appreciates the opportunity to provide comments on the Centers for Medicare

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Falb, Robert Title: Director, U.S. Policy and Advocacy
Organization: Alliance for Regenerative Medicine
Date: 03/16/2019
Comment:

March 16, 2019

Tamara Syrek-Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Blvd.
Baltimore, MD 21244

Cc: Katherine B. Szarama, PhD, Lead Analyst; Lori Paserchia, MD, Lead Medical Officer

Re: National Coverage Decision (NCD) for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Mrs.

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Langenderfer, Lisa Title: Director, Federal Government Relations
Organization: The US Oncology Network
Date: 03/16/2019
Comment:

March 17, 2019

VIA ELECTRONIC SUBMISSION

Tamara Syrek Jensen, JD,
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Director Jensen:

On behalf of the physicians of The US Oncology Network (The Network), I thank you for the opportunity to

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Bird, Karen Title: Executive Director
Organization: Alliance of Dedicated Cancer Centers
Date: 03/15/2019
Comment:

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen,

The Alliance of Dedicated Cancer Centers (ADCC) appreciates the opportunity to comment on Medicare’s proposed decision memorandum

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Speil, Steven Title: EVP, Policy
Organization: FAH
Date: 03/15/2019
Comment:

Charles N. Kahn III
President and CEO

March 15, 2019

VIA ELECTRONIC MAIL AND ELECTRONIC FILING

Tamara Syrek Jensen, JD
Director
Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard S3-02-01
Baltimore, MD 21244

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek

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College of American Pathologists, . Date: 03/15/2019
Comment:

March 15, 2019

Tamara Syrek Jensen, JD, Director
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Katherine B. Szarama, PhD, Lead Analyst
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Lori A. Paserchia, MD, Lead Medical Officer
Evidence and Analysis Group
Centers for Medicare &

More

Eaton, Keith Title: Medical Director, Quality, Safety, and Value
Organization: Seattle Cancer Care Alliance
Date: 03/15/2019
Comment:

March 15, 2018

Tamara Syrek Jensen
Director, Evidence and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard S3-02-01
Baltimore, Maryland 21244
tamara.syrekjensen@cms.hhs.gov

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-Cell Therapy for Cancers

Thank you for this opportunity to comment on Medicare’s National Coverage Determination for

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Miller, Linda Title: Chief Executive Officer
Organization: Foundation for the Accreditation of Cellular Therapy
Date: 03/15/2019
Comment:

Dear Ms. Syrek Jensen:

The Foundation for the Accreditation of Cellular Therapy (FACT) appreciates the opportunity to submit comments regarding the Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N). This letter provides a brief overview of FACT and our comments on the proposed decision memo.

Brief Overview of FACT

The mission of FACT is to improve the quality of cellular therapy through peer-developed

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Bresnahan, Andrew Organization: Northwestern Memorial Hospital
Date: 03/15/2019
Comment:

Dear Administrator Verma:

On behalf of Northwestern Medicine (NM), I wish to thank the Centers for Medicare and Medicaid Services (CMS) for its Proposed Decision Memo (CAG-00451N) for Coverage of Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers under Coverage Evidence Development (CED). CAR T-cell therapy has the extraordinary potential to save lives. It is imperative that a national standard of coverage be established to ensure that Medicare beneficiaries – and all

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Jacobson, Caron Title: Medical Director, Immune Effector Cell Therapy
Organization: Dana-Farber Cancer Institute
Date: 03/15/2019
Comment:

Ms. Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
Room 445-G
200 Independence Avenue, NW
Washington, DC 20201

Tamara Syrek Jensen
Director
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Katherine B. Szarama, PhD
Lead Analyst
Evidence and Analysis

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Miller, Erika Organization: American Society for Transplantation and Cellular Therapy
Date: 03/15/2019
Comment:

March 15, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek-Jensen:

The American Society for Transplantation and Cellular Therapy (ASTCT), formerly the American Society for Blood and Marrow Transplantation (ASBMT),

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Buckner, M.D., Jan Title: Chair - Oncology
Organization: Mayo Clinic
Date: 03/15/2019
Comment:

Ms. Tamara Syrek Jensen
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Department of Health and Human Services

Re: Proposed National Coverage Analysis Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers

Dear Director Syrek Jensen:

We appreciate the opportunity to provide comments on the proposed National Coverage Analysis Decision Memo for Chimeric Antigen Receptor (CAR) T-cell

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McGuirk, Joseph Title: Division Director, Cellular Therapeutics
Organization: The University of Kansas Cancer Center
Date: 03/15/2019
Comment:

March 14, 2019
Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek-Jensen:

The University of Kansas Cancer Center appreciates the opportunity to provide comments on the Centers for Medicare and Medicaid Services’ (CMS) Proposed Decision

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Paredes, Marie-Joy Title: Program Manager
Organization: Cleveland Clinic
Date: 03/15/2019
Comment:

March 15, 2019

Tamara Syrek Jensen, Director
Katherine B. Szarama, PhD, Lead Analyst
Lori A. Paserchia, MD, Lead Medical Officer
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: National Coverage Analysis for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Submitted electronically via: www.cms.gov

Dear Ms. Jensen, Dr. Szarama, and Dr.

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Graham, Camilla Title: Vice President, Medical Affairs
Organization: Sorrento Therapeutics
Date: 03/15/2019
Comment:

Public Comment for: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

March 15, 2019

Sorrento Therapeutics, Inc. based in San Diego, California, USA respectfully submits comments to CMS Decision Memo for coverage of CAR-T therapy for cancers including the standardization of patient reported outcomes.

Sorrento is a clinical stage biopharmaceutical company developing new therapies for cancer. Sorrento is currently

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Brady, Leslie Date: 03/15/2019
Comment:

March 15, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

SUBMITTED ELECTRONICALLY VIA CMS.GOV

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen:

The American Society of Hematology is pleased to offer comments on the Proposed Decision Memo for

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Bondi, Richard Title: Chief Financial Officer
Organization: UPMC Hillman Cancer Center
Date: 03/15/2019
Comment:

Subject: National Coverage Analysis for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Administrator Verma, Ms. Jensen and Drs. Szarama and Paserchia:

UPMC Hillman Cancer Center is pleased to submit comments on the proposed National Coverage Analysis for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers. UPMC Hillman Cancer Center is an NCI designated academic medical center servicing communities in Western and Central

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Okon, Ted Title: Executive Director
Organization: Community Oncology Alliance
Date: 03/15/2019
Comment:

On behalf of the Board of Directors of the Community Oncology Alliance (COA), we are submitting this comment letter regarding the Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N) (the “Coverage Determination”).

As you know, COA is an organization that is dedicated to advocating for the complex care and access needs of patients with cancer and the community oncology practices that serve them. COA is the only non-profit

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Bernstetter, Steve Title: Director, Regulatory Policy and Compliance
Organization: BJC HealthCare
Date: 03/15/2019
Comment:

Thank you for this opportunity to comment on the proposed National Coverage Determination (“NCD”) of Coverage with Evidence Development (“CED”) for Chimeric Antigen Receptor T-cell (“CAR-T”) therapies. BJC Healthcare, our member teaching institution, Barnes-Jewish Hospital, and our physician partners at the Washington University School of Medicine are among the limited number of providers of CAR-T therapies in the mid-west through our Siteman Cancer Centers. Our experience to date

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Negrin, Robert Title: MD, Professor of Medicine
Organization: Stanford Medicine
Date: 03/15/2019
Comment:

The Stanford Blood & Marrow Transplant Program appreciates the opportunity to provide comments on the Centers for Medicare and Medicaid Services’ (CMS) Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N). Stanford Health Care and the Stanford School of Medicine have performed CAR-T therapy since 2016, and we participated in some of the trials that led to current FDA approvals for this life-saving treatment.

In comments submitted in

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Withington, Tara Title: Executive Director
Organization: Society for Immunotherapy of Cancer
Date: 03/15/2019
Comment:

March 17, 2019

Tamara Syrek Jensen, Director
Joseph Chin, MD, Deputy Director
Lori M. Ashby, Director, Policy and Evidence Review
Daniel A. Canos, PhD, Director, Evidence Development
Katherine B. Szarama, PhD, Lead Analyst
Lori A. Paserchia, MD, Lead Medical Officer

Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Determination for Chimeric

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Gallo, Thomas Title: President
Organization: Association of Community Cancer Centers
Date: 03/15/2019
Comment:

March 15, 2019

BY ELECTRONIC DELIVERY

Tamara Syrek Jensen
Director, Evidence and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
S3-02-01
Baltimore, Maryland 21244
CAGinquiries@cms.hhs.gov

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen:

The Association of

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Griffin, Michael Title: Vice President of Advocacy and Public Policy
Organization: AdventHealth
Date: 03/15/2019
Comment:

Dear Ms. Syrek,

AdventHealth is pleased to provide comments in response to CMS’ Coverage Decision Memo for Chimeric Antigen Receptor (CAR)-T cell therapy. Our system includes 46 hospital facilities located across nine states and serves four million people every year. Our flagship facility, AdventHealth Orlando, is the largest single-site Medicare provider in the nation.

In the Coverage Decision Memo, CMS proposes to cover (CAR)-T cell therapy in both the inpatient and

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Pasquini, Marcelo Title: MD,MS
Organization: Center for International Blood and Marrow Transplant Research
Date: 03/15/2019
Comment:

March 16th, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CIBMTR Perspective on the Proposed Decision for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen,

The CMS decision to reimburse for treatment of patients with autologous

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Leppke, Susan Title: Director, Health and Public Policy
Organization: National Marrow Donor Program/Be The Match
Date: 03/15/2019
Comment:

March 15, 2019

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Proposed Decision Memo for the National Coverage Analysis (NCA) for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen,

On behalf of the National Marrow Donor Program®

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Migliori, Richard Title: EVP, Chief Medical Officer
Organization: UnitedHealth Group
Date: 03/15/2019
Comment:

UnitedHealth Group (UHG) supports the Proposed National Coverage Determination for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers. This NCD will ensure Medicare beneficiaries have equal and consistent access to these therapies across the country. In addition to providing beneficiaries access nationwide, UHG believes this NCD will help promote the collection of clinical data to guide evidence based coverage for CAR-T therapies and ensure patient safety in a vulnerable population.

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Stone, Leah Title: Senior Director, Public Policy
Organization: AABB
Date: 03/15/2019
Comment:

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Jensen:

AABB appreciates the opportunity to submit comments in response to the Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-Cell

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Leas, Leigh Anne Title: V.P. and U.S. Country Head, Public Policy
Organization: Novartis Services, Inc.
Date: 03/15/2019
Comment:

March 15, 2019

VIA ELECTRONIC DELIVERY

Tamara Syrek Jensen, JD, Director
Coverage and Analysis Group (CAG)
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Katherine B. Szarama, PhD, Lead Analyst
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Lori A. Paserchia, MD, Lead Medical Officer
Coverage and Analysis

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Gibson, Ben Title: VP
Organization: University of Chicago Medical Center
Date: 03/15/2019
Comment:

March 15 2019

Tamara Syrek Jensen, Director
Joseph Chin, MD, Deputy Director
Lori M. Ashby, Director, Policy and Evidence Review
Daniel A. Canos, PhD, Director, Evidence Development
Katherine B. Szarama, PhD, Lead Analyst
Lori A. Paserchia, MD, Lead Medical Officer
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Determination for Chimeric

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O'Donoghue, Bernadette Title: Vice President, Public Policy
Organization: The Leukemia & Lymphoma Society (LLS)
Date: 03/15/2019
Comment:

March 15, 2019

The Honorable Seema Verma
Administrator, Centers for Medicare & Medicaid Services Department of Health and Human Services
Attention: CAG-00451N 7500 Security Blvd
Baltimore, MD 21244

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Administrator Verma:

The Leukemia and Lymphoma Society (LLS) appreciates the opportunity to submit comments on the Proposed

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Carlson, Robert Title: Chief Executive Officer
Organization: National Comprehensive Cancer Network
Date: 03/15/2019
Comment:

March 15, 2019

Tamara Syrek Jensen, JD, Director
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen:

The National Comprehensive Cancer Network® (NCCN®) is pleased to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed

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MacDonald, Alison Date: 03/15/2019
Comment:

March 15, 2019

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen:

Dartmouth-Hitchcock Health appreciates the opportunity to submit comments addressing the national

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Demske, Amy Organization: Bristol-Myers Squibb
Date: 03/15/2019
Comment:

March 15, 2019

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

VIA ELECTRONIC SUBMISSION

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG—00451N)

Dear Director Syrek Jensen:

Bristol-Myers Squibb Company (BMS) appreciates the

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Shaw, Kate Title: Program Manager
Organization: Association of American Cancer Institutes
Date: 03/15/2019
Comment:

March 15, 2019

Tamara Syrek Jensen, JD
Director
Evidence and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear Ms. Syrek Jensen:

The Association of American Cancer Institutes (AACI) represents 98 National Cancer Institute (NCI)-designated and academic-based cancer centers

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Haltmeyer, Kris Title: Vice President, Legislative & Regulatory Policy
Organization: The Blue Cross Blue Shield Association (BCBSA)
Date: 03/15/2019
Comment:

March 13, 2019

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell therapy for Cancers (CAG-00451N)

Dear Administrator Verma:

The Blue Cross Blue Shield Association (BCBSA) appreciates the opportunity

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Hereford, James Title: President and CEO
Organization: Fairview Health Services
Date: 03/15/2019
Comment:

March 15, 2019

VIA ELECTRONIC SUBMISSION

Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1695-P
P.O. Box 8013
Baltimore, Maryland 21244-1850

Re: Centers for Medicare & Medicaid Services (CMS) Proposed National Coverage Determination for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Dear

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Kennedy, Brian Title: Executive Director
Organization: Alliance for Patient Access (AfPA)
Date: 03/15/2019
Comment:

March 15, 2019

Administrator Seema Verma
Centers for Medicare & Medicaid Services
Department of Health & Human Services
P.O. Box 8013
Baltimore, MD 21244-1850

Submitted electronically at: http://www.regulations.gov

Re: CAG-00451N - National Coverage Determination for Chimeric Antigen Receptor T-Cell Therapies

Dear Administrator Verma:

On behalf of the Alliance for Patient Access (AfPA), I write to thank

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Schwartz, David Title: Head of Global Policy
Organization: Cigna
Date: 03/15/2019
Comment:

March 15, 2019

VIA ELECTRONIC SUBMISSION TO www.cms.gov

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Re: Proposed National Coverage Determination for Chimeric Antigen Receptor T-cell (CAR-T) Therapy for Cancers

Dear Ms. Jensen:

Cigna welcomes the opportunity to respond to the Proposed National

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Battiwalla, Minoo Organization: Centennial Hospital, Nashville
Date: 03/14/2019
Comment:

Dear CMS:

I completely agree with the entirety of the American Society statement below. Please do the right thing to ensure equitable access for CMS patients.
Sincerely,
Minoo Battiwalla

March 15, 2019
Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell

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Bagger, Richard Title: Executive Vice President, Corporate Affairs
Organization: Celgene
Date: 03/14/2019
Comment:

March 15, 2019

BY ELECTRONIC DELIVERY

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
S3-02-01
Baltimore, Maryland 21244
CAGinquiries@cms.hhs.gov

Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

Celgene Corporation (Celgene)

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Tees, Michael Title: Physician, Hematology and Cellular Transplant
Organization: Colorado Blood Cancer Institute
Date: 03/14/2019
Comment:

As a practicing transplant physician understanding the value of CAR T-cell therapy in the treatment of many current and future patients, it is critical that we have this option available for all appropriate patients. Simply put, make the policies in place that allow administration of this therapy to those who meet FDA approved indications. Also simply put, allow the treatment team and center to administer this therapy safely and effectively. For this to occur, adequate compensation is

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Guzman, Alexis Title: Project Manager, Reimbursement Strategy
Organization: The University of Texas MD Anderson Cancer Center
Date: 03/14/2019
Comment:

Brad Gibson, CPA
Vice President and Treasurer
The University of Texas MD Anderson Cancer Center
PO Box 301429, Unit 1697
Houston, TX 77030
713-745-9585
bgibson@mdanderson.org

March 14, 2019

Ms. Seema Verma
Administrator
Centers for Medicare & Medicaid Services (CMS)
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: CAG-00451N, Proposed National Coverage Determination

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Flinn, Susan Title: health policy analyst, future Medicare beneficiary
Organization: self employed
Date: 03/14/2019
Comment:

Hello

I have been watching CMS’ policy development around CAR-T with much interest both as a health policy professional and a future Medicare beneficiary. I understand some of the nuances related to the high price of this therapy and the challenges that creates for payment by different payors including Medicare. I understand a Medicare Advantage plan requested CMS start a National Coverage Analysis for CAR-T since they are concerned about being able to pay for this therapy since

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Hudspeth, Michelle Title: Director, Pediatric Blood and Marrow Transplant
Organization: Medical University of South Carolina?
Date: 03/13/2019
Comment:

Please eliminate the CED requirement and implement an NCD with data collection instead to avoid causing additional access problems for patients. Please also expand the indications that would be covered from patients with relapsed or refractory cancer to indications covered on the FDA approved label; list CIBMTR as an approved registry, and remove the requirement tying PROs to reimbursement for CAR-T.

The proposed changes would directly negatively impact our ability to deliver

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Berry, Kate Title: Senior Vice President for Strategic Planning
Organization: AHIP
Date: 03/12/2019
Comment:

Thank you for the opportunity to provide comments on the Centers for Medicare and Medicaid Services (CMS) Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-Cell Therapy for cancers.

AHIP is the national trade association whose members provide coverage for health care and related services to millions of Americans every day. Through these offerings, we improve and protect the health and financial security of consumers, families, businesses, communities and the nation. We

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NA, NA Date: 03/12/2019
Comment:
Coverage that is contingent on patient behavior up to 24 months after the therapy is very confusing. When patients feel better, indeed, may be fully healed from their cancer, they will likely complete follow-up visits with their primary care physician, but they may not want to see a medical oncologist or think about their terrible cancer again and may choose not to complete the registry or PROs at those later intervals. Will CMS subsequently deny and retract payment because the hospital

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Commenter, Anonymous Date: 03/12/2019
Comment:
It is not clear if CMS will be publishing a list of CMS-approved CAR-T hospitals. Will I also be required to submit a certified letter to CMS that our cell therapy program meets all the requirements including a team and quality manager and a designated patient care area with isolation precautions, and written guidelines about transfer to ICU? What is the process to be approved because patients may have had cells collected, but not yet infused until after May 17, 2019 when the NCD is final

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NA, NA Date: 03/11/2019
Comment:

Hospitals don't have the resources to do the data analysis as described in the section 3.a.iii. It reads “The furnishing hospital shall address the CED questions on all registry patients by tracking the following clinical data elements at baseline, at treatment, and at follow-up 3 months, 6 months, 12 months, and 24 months after the treatment is administered.” There will be too few patients for any meaningful analysis by each individual hospital because each hospitals may only have two or

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Anonymous, Anonymous Date: 03/11/2019
Comment:
I don’t understand why CMS is stating relapsed or refractory and expressing at least one chimeric antigen, I thought this is part of what FDA does with labeling the drugs and is part of the FDA approval process. Why is CMS not accepting the FDA label for coverage? CMS has other policies that cover off-label use of anti-cancer drugs. CMS usually does not limit more than FDA. Why isn’t the NCD just for FDA labeled indications and then data submission like other NCDs are on devices? This

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Gillenwater, Cody Title: Medical director
Organization: Cambia Health Solutions
Date: 03/07/2019
Comment:

To Whom It May Concern-

Thank you for your careful consideration of the matter of CAR T-cell therapy for cancers. While these therapies provide renewed hope for many patients, there is much we still do not know about their long-term efficacy and safety. The proposed coverage with evidence development (CED) takes an important step toward developing our collective knowledge in this regard. The following are comments on the proposed criteria:

The proposed CED criteria

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Reese, Helen Title: Mrs
Date: 03/07/2019
Comment:
Please cover this procedure. [PHI Redacted] had this a year ago at the James Cancer Center in Columbus. It saved her life. Please please please- what a miracle!
Kundu, Suban Title: Yuo
Organization: https://yuo.world
Date: 03/07/2019
Comment:
Very important information. Thank you.
Carpenter, Jackson Date: 03/07/2019
Comment:
I do not know exactly what the CMS is looking for in these comments, however, I do know that a very large majority of Americans are not able to pay hundreds of thousands of dollars for medical treatment. Allowing Medicare to fund CAR-T therapy would be a significant step towards the ultimate goal of affordable access to proper health care for every American. The fact that [PHI Redacted] faces a potential medical bill of almost half of a million dollars is, respectfully,

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Smith, Ralph Title: PhD
Date: 02/25/2019
Comment:
CAR T-cell and TIL therapies were instrumental in saving [PHI Redacted] life after a diagnosis of stage 3 malignant mucousal melanoma. These life-saving therapies should be widely available to all.
Keller, Rebecca Title: Clinical Quality Specialist
Organization: UCHealth Colorado
Date: 02/25/2019
Comment:
I am in full agreement with the proposed coverage. I would love to see it expanded to include TIL (Tumor Infiltrating Lymphocytes) the cousin to CAR T that treats solid tumors. [PHI Redacted] is a recipient of TIL and six months out has no detectable disease. He had stage III mucosal melanoma at the time of his TIL treatment. These adoptive t-cell treatments are changing the lives and outcomes for so many lucky individuals wh