National Coverage Analysis (NCA) View Public Comments

Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

Public Comments

Commenter Comment Information
Cramer, Vanessa Title: Associate Director, Policy
Organization: Ovarian Cancer Research Fund Alliance (OCRFA
Date: 01/18/2018
Comment:

January 17, 2018

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

Re: Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (NCD CAG00450N)

Dear Ms. Jensen:

Ovarian Cancer Research Fund Alliance (OCRFA) is a 501(c)(3) nonprofit organization dedicated to expanding investments in ovarian cancer research and advancing

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Jackson, Cynthia Title: Academic Molecular Laboratory Director
Date: 01/17/2018
Comment:

As an academic molecular pathologist for over 20 years I am writing to express my opposition to the CMS proposal for National Coverage Determination for NGS. During my career molecular diagnostics has grown from a small field of highly specialized testing to a widely used testing modality invaluable for genetics, infectious disease,and more recently oncology. The oncology molecular testing my laboratory performs using NGS is used for diagnosis as well as treatment by directing therapy

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Putcha, Girish Date: 01/17/2018
Comment:

Questions for Commenters

1. Should the proposed NCD be expanded or narrowed by clinical conditions, test methodology to measure the same clinical biomarker, or clinical scenarios? If so, please provide supporting documentation, including peer-reviewed evidence, and a detailed analysis in support of your view.

A challenge here is that one clearly cannot demonstrate that using a specific drug targeting a specific mutation based on results from a specific test improves

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Berry, Anna Title: Director of Genomics Programs
Organization: CellNetix Pathology and Laboratories
Date: 01/17/2018
Comment:

CellNetix Pathology and Laboratories is a large private pathology practice group and an affiliated laboratory located in Seattle, Washington, offering anatomic pathology services and appropriate ancillary testing, including immunohistochemistry, flow cytometry, and molecular testing for cancer and infectious disease, including several next generation sequencing panels for cancer. We examine over 200,000 specimens per year, and work with 25 hospitals across Washington State and in Alaska.

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Bivona, MD, PhD, Trever Title: Associate Professor
Organization: Department of Medicine, UCSF
Date: 01/17/2018
Comment:

January 17, 2018

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

Re: NCD CAG-00450N

Dear Ms. Syrek Jensen,

I applaud the decision linking NCD-level coverage to FDA clearance and approval of NGS testing. I am, however, concerned that the non-coverage section may limit access to comprehensive liquid biopsies for Medicare patients with metastatic

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Chae, Young Kwang Title: Assistant Professor
Organization: Northwestern University Feinberg School of Medicine
Date: 01/17/2018
Comment:

January, 17th, 2018

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

Re: NCD CAG-00450N

Dear Ms. Syrek Jensen,

In my oncology practice at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, I see many patients with advanced cancer. The opportunity to order NGS testing on their tumor DNA and the availability of many targeted

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Nowak, Jonathan Title: Associate Pathologist
Organization: Brigham and Women's Hospital / Dana-Farber Cancer Institute
Date: 01/17/2018
Comment:

Dear CMS,

I am Jonathan Nowak, MD, PhD, Instructor of Pathology, Harvard Medical School, and Associate Pathologist at the Brigham and Women’s Hospital in Boston. I am a board certified molecular genetic pathologist that works closely with my colleagues at the Dana-Farber Cancer Institute (DFCI) to care for patients with a wide variety of advanced solid tumors.

As should be evident to all, an understanding of cancer at a molecular genetic level is essential to refining our

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Hiznay, Mandie Title: caregiver/patient advocate
Date: 01/17/2018
Comment:

My names is Mandie Hiznay and I am a a patient advocate with a [PHI Redacted] who is a 6 1/2 year Stage IV lung cancer Survivor. Thank you for the opportunity to provide comment on the National Coverage Analysis entitled ‘Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer’. Cancer patients all over the country are benefitting from new knowledge in the genomic causes and drivers of cancer, as evidenced by increased access to personalized

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Iafrate, John Title: Professor of Pathology
Organization: Massachusetts General Hospital
Date: 01/17/2018
Comment:

Dear CMS,

As an academic pathologist and molecular diagnostic lab director performing LDT next generation sequencing sequencing of tumors at the Massachusetts General Hospital, I would like to express my concern with the proposed payment policy for cancer NGS. I believe the policy essentially gives Foundation Medicine a monopoly in this space, since there are no other FDA approved assays that have 5 or more genes clinically validated (i.e. Illumina and ThermoFisher Assays would not

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Lanman, Richard Title: MD
Organization: Guardant Health
Date: 01/17/2018
Comment:

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

RE: Proposed Decision Memorandum for National Coverage Analysis (NCA) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Jensen:

Guardant Health appreciates the opportunity to comment on CMS’ proposed

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Laudadio, Jennifer Title: MD
Date: 01/17/2018
Comment:

Thank you for the opportunity to review and comment on CMS’ proposed national coverage determination (NCD) entitled “Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N).”

I am a practicing molecular pathologist and an expert in the diagnosis of disease at the molecular level. I am commenting as private citizen. The laboratory that I work in does not perform next-generation sequencing (NGS) for clinical care, and I can therefore comment

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Fleurence, Rachael Title: Executive Director
Organization: NESTcc
Date: 01/17/2018
Comment:
The National Evaluation System for health Technology Coordinating Center (NESTcc) was formally launched in 2017 with the mission to support the timely, reliable, and cost-effective development of evidence using high quality real world data (including Electronic Health Records, claims, patient and device generated data etc.). The NESTcc Governing Committee is a multi-stakeholder representation including the medical device industry, the FDA, CMS, private payers, health systems, researchers,

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Padilla, MD, Mary Title: VP
Organization: Personal Genome Diagnostics, Inc
Date: 01/17/2018
Comment:

CMS Leadership
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard, Baltimore, MD 21244

Dear CMS Leadership,

On behalf of Personal Genome Diagnostics, we thank you for providing this opportunity to comment and support of the Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N).

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking

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Crothers, Barbara A Title: President
Organization: American Society of Cytopathology
Date: 01/17/2018
Comment:

Comment on CMS’ proposed Non-Coverage Determination (NCD) for Next Generation Sequencing (NGS)-based tests from the American Society of Cytopathology

The proposal for Non-Coverage Determination (NCD) for certain Next Generation Sequencing (NGS) testing has severe adverse unintended consequences that have come to the attention of the American Society of Cytopathology. CMS may not have been apprised of these consequences by other parties who have commented on the proposal. The

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Doebele, Robert Title: Associate Professor of Medicine
Organization: University of Colorado
Date: 01/17/2018
Comment:

Thank you for the opportunity to provide comment on the Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N). I am a medical oncologist, specializing in the treatment of patients with lung cancer, and have witnessed firsthand the progress in personalized medicine and targeted therapy that has occurred over the last decade. The remarkable advances in survival in lung cancer have been made possible in large part due to the

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Goede, Patrica Title: VP Clinical Informatics
Organization: XIFIN, Inc
Date: 01/17/2018
Comment:

January 17, 2018

Tamara Syrek-Jensen, JD
Director, Coverage and Analysis Group

Joseph Chin, MD, MS
Deputy Director, Coverage and Analysis Group

Katherine B. Szarama, PhD
Lead Analyst
katherine.szarama@cms.hhs.gov

RE: CAG-00450N Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

Dear Ms. Syrek-Jensen and Drs. Chin and Szarama:

On behalf of XIFIN, Inc, we

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Linthicum, Kimberly Title: Vice President, Government Affairs
Organization: Myriad Genetic Laboratories, Inc.
Date: 01/17/2018
Comment:

January 17, 2018

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

Re: Proposed Decision Memorandum for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Director Jensen:

Myriad Genetic Laboratories, Inc. is pleased to submit these comments on the Centers for Medicare & Medicaid

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Phillips, Steve Title: Senior Director, Coverage & Reimbursement Policy
Organization: Johnson & Johnson
Date: 01/17/2018
Comment:

On behalf of Johnson & Johnson (“J&J”), I am pleased to offer the following comments on the Centers for Medicare & Medicaid Services’ (CMS) Proposed Coverage Decision Memorandum (NCD) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.

Advances in science and technology are opening new horizons in healthcare and hold the promise of truly precise, personalized medicine. Today’s healthcare systems demand improved medical outcomes at lower costs, and

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Sadri, Navid Title: Medical Director, UHTL
Organization: University Hospitals Cleveland Medical Center
Date: 01/17/2018
Comment:

I’d like to thank CMS for the opportunity to comment on the proposed NCD for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer. I am a board-certified molecular genetic pathologist and the medical director of a CLIA-certified laboratory that provides laboratory developed NGS-based oncology testing. As part of a multidisciplinary team, I work closely with oncologist, pathologist, and other health care staff to provide appropriate, quick, accurate, and

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Pritchard, Colin Title: Associate Professor of Laboratory Medicine
Organization: University of Washington
Date: 01/17/2018
Comment:

January 17, 2018

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244
Submitted via email: tamara.syrekjensen@cms.hhs.gov and the NCA Docket at CAGinquiries@cms.hhs.gov

Dear Ms. Jensen,

I am an academic molecular pathologist at the University of Washington, where I co-direct the Genetics and Solid Tumors Laboratory that offers billable clinical

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Lawrence, Carolyn Title: Bioinformatician
Organization: Colorado Center For Personalized Medicine
Date: 01/17/2018
Comment:

This proposed decision for requiring FDA approval for NGS testing assays for cancer patients will have a detrimental effect on patient care, and stifle research and innovation in the rapidly evolving field of precision medicine.

Many hospitals, companies, and academic institutions across the country provide NGS testing to their patients in an already highly controlled and regulated manner. In many cases these tests have proved invaluable for directing patient treatment plans. The

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Fisher, Karen Title: Chief Public Policy Officer
Organization: Association of American Medical Colleges
Date: 01/17/2018
Comment:

January 17, 2018

Ms. Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mail Stop #S3-02-01
7500 Security Boulevard
Baltimore, Maryland 21244

RE: Proposed Decision Memo “Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)”

Dear Ms. Jensen,

The Association of American Medical Colleges

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Currie, Alex Title: Director of Federal Relations
Organization: Vanderbilt University Medical Center
Date: 01/17/2018
Comment:

SUBMITTED ELECTRONICALLY

Dear Director Jensen,

We thank you for providing this opportunity to comment on a proposed National Coverage Decision (NCD) regarding Next Generation Sequencing (NGS) analysis of tumors from patients with advanced cancer. We applaud CMS for proposing to provide coverage for next generation sequencing, which will give Medicare patients the opportunity to receive accurate, individualized, and effective care. We are glad that CMS acknowledges that NGS

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Oncologists, University of Colorado Date: 01/17/2018
Comment:

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

Re: Centers for Medicare & Medicaid Services (CMS) Proposed National Coverage Determination for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Jensen,

Thank you for the opportunity to provide comments on the above referenced proposed

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Burke, Tara Title: Director, Public Policy and Advocacy
Organization: Association for Molecular Pathology
Date: 01/17/2018
Comment:

January 17, 2018

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

RE: Proposed Decision Memorandum on Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG #00450N)

Dear Ms. Jensen,

The Association for Molecular Pathology (AMP) is pleased to offer comments on the proposed decision memorandum entitled, “Next

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Yourshaw, Michael Title: Bioinformatician
Organization: Colorado Center for Personalized Medicine
Date: 01/17/2018
Comment:

I am a Bioinformatician, with a PhD in Human Genetics from UCLA, at the Colorado Personalized Medicine Center. My work consists of developing, in collaboration with pathologists and genetics professionals, software for the analysis and visualization of Next Generation Sequencing (NGS) data within the context of a CLIA-certified laboratory. In addition, I am covered by Medicare and, thus, concerned with the quality, availability, and cost of NGS testing.

As a matter of law and

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Wilberger, Adam Title: Resident Physician, Pathology
Organization: University of Colorado School of Medicine
Date: 01/17/2018
Comment:

I am a 5th year resident physician in pathology spending my entire year in the molecular laboratory. Throughout residency, and especially this year, I have learned the incredible value of NGS in patient care. And while NGS is a fantastic tool, if performed incorrectly it can lead to just as great of problems.

During training, I have been thoroughly educated on the importance of proper lab practices, quality control, lab certification, and lab management. In spending time in the

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Ferris, Andrea Title: President and Chief Executive Officer
Organization: LUNGevity Foundation
Date: 01/17/2018
Comment:

January 17, 2018

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

Dear Ms. Syrek Jensen,

On behalf of LUNGevity Foundation, the nation’s preeminent lung cancer nonprofit that funds research, provides education and support, and builds communities for the 222,500 Americans diagnosed

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Sidiropoulos, Nikoletta Title: Medical Director, Genomic Medicine Program
Organization: University of Vermont Health Network
Date: 01/17/2018
Comment:

Submitted via email to CAGinquiries@cms.hhs.gov

January 17, 2018

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

Re: Proposed Decision Memo for Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer CAG-00450N

Dear Sir/Madam:

As the Medical Director and a practicing molecular

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Rosenbaum, Jason Title: Assistant Professor
Organization: University of Pennsylvania Center for Personalized Diagnostics
Date: 01/17/2018
Comment:

To Whom It May Concern:

I am a molecular pathologist specializing in massively parallel sequencing (MPS, commonly referred to as next-generation sequencing or NGS). I am certified by the American Board of Pathology in Molecular Pathology, Anatomic Pathology, and Clinical Pathology. As a physician, my primary concern is for my patients, and the Center for Medicare & Medicaid Services (CMS) shares my priorities. Nevertheless, as a physician I believe it is my responsibility to convey

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Menser, Lauren Date: 01/17/2018
Comment:

January 17, 2018

Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Dear Ms. Verma:

The five undersigned organizations request that you do not finalize the National Coverage Analysis entitled, Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer, as currently drafted. Our

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Wimmer, Harold Title: National President & CEO
Organization: American Lung Association
Date: 01/17/2018
Comment:

January 17, 2018

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

Dear Ms. Jensen:

The American Lung Association appreciates the opportunity to submit comments on National Coverage Determination on Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N).

The American

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Raez, Luis Title: Chief of Hematology/Oncology and Medical Director
Organization: Memorial Cancer Institute/Florida International University
Date: 01/17/2018
Comment:

Re: NCD CAG-00450N

Dear Ms. Syrek Jensen,

I am writing to voice my alarm at some of the restrictive elements of the proposed NCD covering NGS-based testing in advanced cancer. I welcome Medicare coverage of NGS testing. In fact, it is long overdue. But the draft policy would limit my choices for how I can care for Medicare patients. Please change it to address some of its obvious deficits.

I would contend that the introduction of comprehensive liquid

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Schlager, Lisa Title: Vice President, Public Policy
Organization: FORCE: Facing Our Risk of Cancer Empowered
Date: 01/17/2018
Comment:

On behalf of Facing Our Risk of Cancer Empowered (FORCE) and Living Beyond Breast Cancer, we are pleased to submit the following comments regarding the proposed National Coverage Determination (NCD) “Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.”

We support the Food and Drug Administration (FDA) and Centers for Medicare and Medicare Services (CMS) Parallel Review program to streamline approval and coverage processes. We also applaud the CMS

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Darbro, Benjamin Title: Assistant Professor of Pediatrics
Organization: University of Iowa
Date: 01/17/2018
Comment:
Our nation’s network of Academic University hospital NGS diagnostic laboratories provide high quality and heavily regulated services that are valuable, critical, and worthy of Medicare reimbursement. I am extremely concerned that the NCD, by tying all future reimbursement for our NGS based tests to FDA approval, creates a novel and extremely burdensome additional laboratory oversight regime that is not consistent with current legislation and which is incompatible with the continued practice of

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Rioth, Matthew Title: Assistant Professor of Medicine, Biomedical Inform
Date: 01/17/2018
Comment:
I am concerned that limiting CMS coverage for FDA-approved tests will needlessly hamper innovation in the field of biomarker discovery and precision oncology. While it is appropriate that the validity of these assays should be vetted, the requirement of FDA approval will likely be too onerous for all but the largest commercial labs to obtain. This will decrease competition and innovation in that space.
George, Sean Title: President and CEO
Organization: Invitae Corporation
Date: 01/17/2018
Comment:

January 17, 2018

Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Re: Proposed Decision Memorandum for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Verma:

Thank you for the opportunity to submit comments on the National Coverage

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Ring, Russell Organization: Roche Diagnostics Corporation
Date: 01/17/2018
Comment:

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

RE: Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Jensen:

Roche Diagnostics Corporation (“Roche”) is pleased to submit comments regarding the Proposed Decision Memo for Next Generation

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Zehnder, James Title: Professor of Pathology and Medicine
Organization: Stanford University
Date: 01/17/2018
Comment:
I am writing to urge you to preserve the innovation and personalized care accruing from academic laboratories developing and validating NGS methods for clinical use. This work benefits everyone and is rigorously quality controlled via the CAP accreditation process. University laboratories provide a mechanism for rapid translation of basic science advances to clinical patient care, in a way that not be done if this testing were restricted to a few large commercial labs.
Gocke, Christopher Title: Director, Division of Molecular Pathology
Organization: Johns Hopkins University School of Medicine
Date: 01/17/2018
Comment:

January 17, 2018
Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

CG# 00450N

Dear Ms. Jensen,

I am writing to express my disagreement with the “Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)”. As the director of a large CLIA licensed hospital molecular pathology

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Sheives, Paul Title: VP, Reimbursement & Regulatory Policy
Organization: American Clinical Laboratory Association
Date: 01/17/2018
Comment:

January 17, 2018

Ms. Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mail Stop #S3-02-01
7500 Security Boulevard
Baltimore, Maryland 21244

Dear Ms. Jensen,

Please accept these comments from the American Clinical Laboratory Association (ACLA) on the proposed decision memo titled "Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced

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Bens, Cynthia Title: Senior Vice President, Public Policy
Organization: Personalized Medicine Coalition
Date: 01/17/2018
Comment:

January 17, 2018

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 Medicare Coverage Decision Memorandum for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Syrek Jensen:

The Personalized Medicine

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Das, Soma Title: Professor and molecular laboratory director
Organization: University of Chicago
Date: 01/17/2018
Comment:

I am writing to oppose the proposed national coverage determination being considered by the Centers for Medicare and Medicaid Services. I am a professor in a highly regarded academic institution and the director of a molecular diagnostic laboratory that performs genetic and genomic testing for patients nationwide. The majority of molecular genetic tests available are laboratory developed tests (LDTs) which go through the rigor of CAP and CLIA guidelines. Next generation sequencing-based

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Aisner, Dara Title: Associate Professor
Organization: University of Colorado
Date: 01/17/2018
Comment:

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

Dear Ms. Jensen:

Thank you for the opportunity to comment on the National Coverage Analysis ‘National Coverage Analysis (NCA) Tracking Sheet for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)’. I am a molecular pathologist and laboratory director at the

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Melby, Glen Date: 01/17/2018
Comment:

My name is Glen Melby. [PHI Redacted]

The treatment [PHI Redacted] received is directly related to the genetic testing performed. As the new drugs improve [PHI Redacted] chances for survival, so also will continued genetic research being done with cancer cells. I hope to always have access to the best science has to offer. If further genetic testing will allow [PHI Redacted] to keep fighting, I hope that option is

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Bankowitz, Richard Title: Chief Medical Officer
Organization: America's Health Insurance Plans
Date: 01/17/2018
Comment:

America’s Health Insurance Plans (AHIP) appreciates the opportunity to comment on the national coverage analysis for NGS for Medicare beneficiaries with advanced cancer.

While the new diagnostic test - F1CDx™ - may help to identify a number of different genetic tumor mutations that may benefit from Food and Drug Administration-approved targeted treatment options (at this point in time: fifteen), the majority of genetic mutations identified by the F1CDx remain under

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David, Marjorie Title: Molecular Genetic Pathology Fellow
Organization: Baylor College of Medicine, Association for Molecular Pathology
Date: 01/17/2018
Comment:
Required FDA approval for NGS testing will definitely harm actual patient carethis could be you or your friend or family member. CAP currently has excellent and rigorous guidelines in place to regulate the quality of testing in individual laboratories for non-FDA approved test. This additional proposal only adds harmful regulation that will benefit a very few large companies. Current actionable findings that help patients now will be lost with this proposal. Future innovations will be

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Harbison, Jennifer Title: Director of Health Policy
Organization: University of Iowa Health Care
Date: 01/17/2018
Comment:

January 17, 2018

Ms. Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mail Stop #S3-02-01
7500 Security Boulevard
Baltimore, Maryland 21244

RE: Proposed Decision Memo “Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)”

Submitted electronically

Dear Ms. Jensen,

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alikhan, mir Title: attending physician
Organization: NorthShore University HealthSystem
Date: 01/17/2018
Comment:
I believe this policy is regressive in terms of academic centers to be able to continue their investigative work. For this to happen, there should be an equal financial opportunity and footing for all labs. If only one entity is given preference, this will restrict others from their projects and will negatively impact the discovery of molecular and genetic etiologies of disease.
Sholl, Lynette Title: Associate Medical Director, CAMD
Organization: Brigham and Women's Hospital
Date: 01/17/2018
Comment:

Thank you for allowing me to provide my comments on this national coverage determination. It is encouraging to learn that CMS is considering a policy that may provide a framework for consistent payment of next generation sequencing panel testing for Medicare recipients. However the current scope of the NCD is concerning; in particular the requirement for FDA approval is onerous and in all likelihood would lead to a centralization of NGS for cancer testing to a few commercial laboratories

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Appleberry, Ginger Title: Associate General Counsel
Organization: Caris Life Sciences
Date: 01/17/2018
Comment:

Foundation Medicine submitted on November 17, 2017, a request to the Centers for Medicare & Medicaid Services ("CMS") for a national coverage determination as part of the Parallel Review process for the FoundationOne CDx device ("F1CDx"), an advanced cancer screening test employing next generation sequencing technology. CMS issued the Proposed Decision Memorandum for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N) (the "Proposed NCD") on

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Daniele, Alessia Organization: Weill Cornell Medicine
Date: 01/17/2018
Comment:

January 16, 2018

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

Re: NCD CAG-00450N

Dear Ms. Syrek Jensen,

Weill Cornell Medicine (WCM) is committed to excellence in patient care, scientific discovery and the education of future physicians in New York City and around the world. The doctors and scientists of WCM are engaged in

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Demske, Amy Title: Director, Federal Payment Agencies
Organization: Bristol-Myers Squibb
Date: 01/17/2018
Comment:

January 17, 2018

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

Re:Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Syrek Jensen:

Bristol-Myers Squibb Company (BMS) appreciates the opportunity to submit the following comments

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Mansukhani, Mahesh Title: Associate Professor of Pathology and Cell Biology
Organization: Columbia University Irving Medical Center
Date: 01/17/2018
Comment:

Thank you for the opportunity to offer comments on the “Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)”.

The proposal to cover oncology testing with NGS platforms is a move in the positive direction, and I applaud your thoughtful approach to this. There are, however, a some serious concerns:

  1. NGS is not a “test” but a technology, that can be used for single gene assays, multigene discrete

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Grenert, James Title: MD, PhD, Medical Director
Organization: UCSF Clinical Cancer Genomics Laboratory
Date: 01/17/2018
Comment:

While it is encouraging to see that CMS recognizes the use and utility of next-generation sequencing (NGS) for treatment of cancer patients, there are several aspects of its proposed decision memo that raise significant concerns.
The most troubling aspect of the proposal is the limitation of reimbursement to FDA-approved assays. This will have a chilling effect on molecular laboratories in academic medical centers which, by and large, do not have the financial resources to carry out

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Nall, Mike Title: Chief Executive Officer
Organization: Biocept
Date: 01/17/2018
Comment:

January 16, 2018

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

Re: Proposed Decision Memorandum for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Director Syrek-Jensen:

On behalf of Biocept, Inc. we appreciate the opportunity to comment on the Proposed Decision

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Schulze, Matthew Title: Director, Center for Public Policy
Organization: American Society for Clinical Pathology
Date: 01/17/2018
Comment:

January 17, 2018

Ms. 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

Dear Ms. Jensen:

On behalf of the American Society of Clinical Pathology (ASCP), I am writing to provide comment on the proposed National Coverage Determination for the FoundationOne CDx (F1CDx) next generation sequencing (NGS)-based

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Drazan, Ken Title: President
Organization: GRAIL, Inc.
Date: 01/17/2018
Comment:

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

Re: Comments on Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG #00450N)

GRAIL, Inc. (GRAIL) is pleased to provide comments on the Centers for Medicare & Medicaid Services (CMS) proposed decision memo for Next Generation

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Seifert, Robert Title: Pathologist
Organization: University of Florida
Date: 01/17/2018
Comment:
This limitation would lead to a monopoly and severely limit innovation and research. The cost of these tests would increase dramatically. Furthermore there is no guarantee that these changes would improve patient safety and quality.
Onciu, Mihaela Title: Medical Director, OncoMetrix Laboratory
Organization: Poplar Healthcare
Date: 01/17/2018
Comment:

I am writing to you regarding your recent National Coverage Decision (NCD) (CAG-00450N). I am the Medical Director of OncoMetrix Laboratory, a part of Poplar Healthcare in Memphis, TN. Poplar Healthcare is a national anatomic and molecular pathology laboratory servicing thousands of treating physicians throughout the United States. Our staff of over 40 surgical pathologists receive well over 1,000 cases daily for histologic diagnosis. Many of these cases also require additional

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Flannery, David Title: Medical Director
Organization: American College of Medical Genetics and Genomics
Date: 01/17/2018
Comment:

The American College of Medical Genetics and Genomics (ACMG) welcomes the opportunity to comment on the proposed National Coverage Determination (NCD) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer. Our 2000 members are clinicians who evaluate, diagnose, and treat patients with genetic disorders, and laboratory medical geneticists who perform genetic and genomic testing. Our guiding principles regarding genetic and genomic testing policy are to ensure

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O'Connor, Mallory Title: Director, Healthcare Policy & Federal Programs
Organization: Biotechnology Innovation Organization
Date: 01/17/2018
Comment:

BIO COMMENTS RE: Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’) National Coverage Analysis (NCA) and proposed decision memo for Next Generation Sequencing (NGS) for Medicare beneficiaries with Advanced Cancer. BIO is the world's largest trade association

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Bird, Karen Title: Executive Director
Organization: Alliance of Dedicated Cancer Centers
Date: 01/17/2018
Comment:

By Electronic Delivery at: www.regulations.gov

Ms. Seema Verma
Administrator
Centers for Medicare & Medicaid Services (CMS)
Department of Health and Human Services
7500 Security Blvd.
Baltimore, MD 21244-8013

RE: Comments on the Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Administrator Verma:

The Alliance of Dedicated Cancer Centers (“ADCC”

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Marcanti, Barbara Title: Director, Strategic Reimbursement
Organization: NeoGenomics Laboratory
Date: 01/17/2018
Comment:

January 16, 2018

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

RE: Response to Request for Public Comment Period: Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Jensen:

NeoGenomics Laboratories wishes to provide CMS its comments on the

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Perlmutter, David Title: Exec Vice Chancellor for Medical Affairs and Dean
Organization: Washington University School of Medicine in St. Louis
Date: 01/17/2018
Comment:

January 17, 2018

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

Re: Proposed Decision Memo “Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)”

Submitted electronically

Dear Ms. Jensen:

On behalf of Washington University in St. Louis and its School of Medicine, I am writing to comment on

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Banitt, Tracy Date: 01/17/2018
Comment:
I feel this testing is very valuable to the diagnostic process for Advanced Cancer treatment. Please ensure this diagnostic tool is covered by Medicare
Branham, Chandra Organization: AdvaMed
Date: 01/17/2018
Comment:

January 17, 2018

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

RE: Proposed Medicare Coverage Decision Memorandum for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Syrek Jensen:

The Advanced

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Flax, Sherri Title: Vice Chair, Clinical Affairs, Dept. of Pathology
Organization: University of Florida
Date: 01/17/2018
Comment:
The Proposed Decision Memo for NGS for Medicare Beneficiaries with Advanced Cancer (CAG-00450N) is unduly burdensome on molecular laboratories. Most molecular labs have their own laboratory developed tests or modifications of existing FDA-approved molecular kits. Limiting coverage to FDA-approved tests basically gives Foundation Medicine a monopoly and will drastically impact the ability of many academic centers to provide timely care to cancer patients. Our center provides testing similar,

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Auerbach, Jena Title: Dr.
Organization: University of Florida
Date: 01/17/2018
Comment:
Regarding the proposed decision memo about NGS testing...
If only one lab has FDA approval, this is not conducive to healthcare. A monopoly leads to an increased price and inhibition of research.
Druker, Brian Title: Director, OHSU Knight Cancer Institute, JELD-WEN C
Organization: Oregon Health Science University/Knight Cancer Institute
Date: 01/17/2018
Comment:

The OHSU Knight Cancer Center (KCI) has been designated by the National Cancer Institute as a Comprehensive Cancer Center, the agency’s highest distinction. KCI is internationally recognized as a leader in cancer research and treatment, as well as a pioneer of personalized cancer medicine. The institute is a part of OHSU who employs over 15,000 people which includes some of the world’s leading researchers and physicians in the tireless care of over 303,000 patients each year. Critical to

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Wilson, MS, Nonda Organization: On behalf of the College of American Pathologists
Date: 01/17/2018
Comment:

January 17, 2018

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

RE: Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Jensen,

Thank you for the opportunity to review and comment on CMS’ proposed national coverage determination (NCD) entitled “Next Generation Sequencing (NGS) for

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Febbo, Phillip Title: Chief Medical Officer
Organization: Genomic Health, Inc.
Date: 01/17/2018
Comment:

January 17, 2018

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Medicare & Medicaid Services
Mail stop #S3-02-01
7500 Security Blvd
Baltimore, MD 21244-1850

RE: Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Director Jensen:

On behalf of Genomic Health, Inc., I am submitting comments regarding CMS’ Proposed

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Rodic, Nemanja Title: Assistant Professor of Pathology
Organization: University of Florida
Date: 01/17/2018
Comment:

On 1/17/2018, at 12:48 pm

Dear Sir or Madame:

In reference to, Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-450-N), please note that I oppose requiring laboratories to use FDA-approved companion assays. Allowing such singular monopoly would destroy NGS-based laboratory develop testing assays that are both analytically and clinically just as sensitive and specific as FDA-approved tests. This proposition is an

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MALMBERG, Donna Date: 01/17/2018
Comment:

[PHI Redacted]

Thank you for the opportunity to provide comment on the National Coverage Analysis entitled ‘Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer’. Cancer patients all over the country are benefitting from new knowledge in the genomic causes and drivers of cancer, as evidenced by increased access to personalized therapeutics and care based on the genetic makeup of cancer. We are grateful for advances in diagnostic

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Akkari, Yassmine Title: Scientific Director
Organization: Legacy Health
Date: 01/17/2018
Comment:

First, I would like to thank CMS for the opportunity to comment on the proposed decision memo on NGS coverage for Medicare beneficiaries with advanced cancer (CAG-00540N). I appreciate the opportunity to comment on this issue, as a laboratory director, ABMGG-certified in Clinical Molecular Genetics, Cytogenetics, and Ph.D. Medical Genetics, serving the Portland metropolitan region in Oregon and Southwest Washington. Our Molecular Pathology laboratory offers laboratory-developed tests that

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Blakely, MD, PhD, Collin Title: Assistant Professor
Organization: UCSF Helen Diller Comprehensive Cancer Center
Date: 01/17/2018
Comment:

January 17, 2018

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

Re: NCD CAG-00450N

Dear Ms. Syrek Jensen,

I support many of the policies put forth in the draft NCD referenced above. However, some language in the draft may limit my choices for how I care for Medicare patients and should be changed.

In my lung cancer

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Quinn, Bruce Title: Principal
Organization: Bruce Quinn Associates LLC
Date: 01/17/2018
Comment:

This is a brief summary of comments submitted by PDF with illustrations and graphics.

CMS should be applauded for its bold effort to transform Medicare oncology care to a learning healthcare system. However, the NCD rules lead to a number of serious unintended consequences. It would be far better to develop a program in the way the Oncology Care Model was developed, with town halls, requests for information, and selection among proposals and fully vetted options against clear and

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Hamilton, Stanley Date: 01/17/2018
Comment:

Coordinated Comments from a University of Texas System Molecular Diagnostics Laboratory Coalition on CMS Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

January 16, 2018

A coalition of molecular diagnostics laboratories at The University of Texas MD Anderson Cancer Center (MD Anderson), The University of Texas Southwestern Medical Center (UTSWMC), and The University of Texas Medical Branch (UTMB) at

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Miller, Vincent Title: Chief Medical Officer
Organization: Foundation Medicine
Date: 01/17/2018
Comment:

January 17, 2018

VIA Electronic Mail to: CAGinquiries@cms.hhs.gov

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

RE: Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Jensen:

On behalf of Foundation Medicine, Inc.

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Hansen, Christopher Title: President
Organization: American Cancer Society Cancer Action Network
Date: 01/17/2018
Comment:

January 17, 2018

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

Re: Coverage of NGS tumor panels-CAG-00450N

Dear Ms. Jensen,

The American Cancer Society Cancer Action Network (ACS CAN) appreciates the opportunity to submit comments regarding the national coverage

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Brockstein, Bruce Title: MD
Organization: NorthShore University HealthSystem
Date: 01/17/2018
Comment:

I would like to raise my concern about the recently proposed national coverage determination from CMS regarding NGS testing in oncology.

Precision laboratories are fundamental to precision oncology and are an important part of patient care; it is critical that these tests be performed according to quality standards in a variety of settings and centers, and that they be able to contribute to ongoing advances as well.

The recently proposed national coverage determination

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Schadt, Eric Title: Founder and CEO
Organization: Sema4
Date: 01/17/2018
Comment:

January 17, 2018

Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

Re: Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Verma:

On behalf of Sema4, thank you for the opportunity to submit comments on the

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Bauml, Joshua Title: Assistant Professor of Medicine
Organization: Perelman School of Medicine at the University of Pennsylvania
Date: 01/17/2018
Comment:

To Whom it May Concern:

I am an academic medical oncologist, focusing largely on the treatment of lung cancers. While thoracic oncology has led the way in terms of incorporation of NGS testing, I feel the proposed approval has significant limitations. First, it broadly applies NGS to tumors without established targets. In this role, it goes a bit "too far". Next, it limits approved testing to once per patient. This is a huge problem for patients receiving targeted therapies

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Ramalingam, Suresh Title: Professor of Hematology and Medical Oncology
Organization: Winship Cancer Institute of Emory University
Date: 01/17/2018
Comment:

I am a medical oncologist and researcher at Emory University. In addition to regularly seeing patients with metastatic cancer, I also conduct research into new therapeutic and diagnostic technologies. I am concerned that elements of the referenced draft NCD are too restrictive and might inadvertently reduce access of Medicare patients to high quality cancer care.

I am thinking specifically of the way the NCD treats comprehensive liquid biopsies. I have used the liquid biopsies test

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Withington, Tara Title: Executive Director
Organization: Society for Immunotherapy of Cancer
Date: 01/17/2018
Comment:

Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-8013
SENT ELECTRONICALLY TO: at press@cms.hhs.gov

We are writing to comment on the Proposed Decision Memorandum for Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer (CAG-00450N), issued by the Centers for Medicare and Medicaid Services (CMS) on November 30th, 2017.

The Society for Immunotherapy of Cancer

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Casebeer, Corinne Date: 01/17/2018
Comment:

[PHI Redacted]

I tell you this because I want to comment on the National Coverage Analysis entitled ‘Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer’. Cancer patients all over the country are benefitting from new knowledge in the genomic causes and drivers of cancer, as evidenced by increased access to personalized therapeutics and care based on the genetic makeup of cancer. We are grateful for advances in diagnostic technologies,

More

McCoach, Caroline Title: Assistant Professor
Organization: University of California, San Francisco
Date: 01/17/2018
Comment:

January, 16, 2018

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

Re: NCD CAG-00450N

Dear Ms. Syrek Jensen,

Thank you for providing this chance for the public to comment on the proposed NCD covering tissue-based NGS testing. This type of testing has truly become part of the standard of care for me at the University of San Francisco Helen Diller

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Moshkevich, Solomon Title: SVP Product & Strategy
Organization: Natera
Date: 01/17/2018
Comment:

Thank you for the opportunity to comment on the CMS decision.

Natera is a leader in innovative genetic testing with businesses focused on reproductive health and oncology. Our CLIA-certified and CAP-accredited laboratory in California has processed over 1 million cell-free DNA tests over the past five years. We have a nascent business in oncology, which we believe will help save many lives among people battling cancer, and which may be affected by the new National Coverage

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Lee, Brendan Title: Professor & Chairman
Organization: Baylor College of Medicine & Dept. Molecular and Human Genetics
Date: 01/17/2018
Comment:

We at Baylor College of Medicine are very concerned about the “Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N). The proposed regulation is anti-competitive and would adversely affect innovation, patient care, and implementation of personalized medicine. As such, it would dramatically hinder the goals espoused by the 21st Century Cures Act. This act, passed with bipartisan support of Congress, aims to bring state of

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CORDON-CARDO, CARLOS Title: Chariman Department of Pathology
Organization: The Mount Sinai Health System
Date: 01/17/2018
Comment:

January 17, 2018

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

RE:   Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms.Jensen:

We are writing to comment on the Proposed Decision Memorandum for Next

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Dietzen, PhD, DABCC, FAACC, Dennis J. Title: President
Organization: The American Association for Clinical Chemistry (AACC)
Date: 01/17/2018
Comment:
January 17, 2018
Centers for Medicare and Medicaid Services
Coverage and Analysis Group
7500 Security Blvd
Baltimore, Maryland   21244

Subj: Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Sir/Madam:

The American Association for Clinical Chemistry (AACC) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) proposed national coverage determination (NCD) for Next

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Finley, JD, LL.M, Marisa Title: Vice President, Center for Healthcare Policy
Organization: Baylor Scott & White Health
Date: 01/17/2018
Comment:

January 17, 2018

Ms. Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mail Stop #S3-02-01
7500 Security Boulevard
Baltimore, Maryland 21244

RE: Proposed Decision Memo “Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)”

Submitted electronically

Dear Ms. Jensen,

Baylor

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Greco, Laura Organization: ALK Positive
Date: 01/17/2018
Comment:

January 17, 2018

To the Centers for Medicare & Medicaid Services:

Re: Proposed Decision Memorandum on Next Generation Sequencing (“NGS”) for Medicare Beneficiaries with Advanced Cancer

We represent the community ALK Positive, a group of more than 800 survivors and caregivers of individuals with advanced anaplastic lymphoma kinase (“ALK”) positive Non-Small Cell Lung Cancer (“NSCLC”). ALK translocations in NSCLC are estimated to affect approximately 5% of NSCLC

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Kerins, Jr., Raymond F. Title: Senior Vice President, Head of Communications
Organization: Bayer Corporation ("Bayer")
Date: 01/17/2018
Comment:

January 15, 2018

Via Electronic Submission:

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

Subject: Medicare Program: National Coverage Analysis (NCA) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Syrek

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Kodityal, MD, Sandeep Title: Assistant Professor of Hematology-Oncology
Organization: Baylor College of Medicine
Date: 01/17/2018
Comment:

To Whom It May Concern,

I would like to congratulate the FDA and CMS for recent decisions regarding Next Generation Sequencing. As a full time medical oncologist, I have found that NGS has provided my patients with advanced disease the ability to access biomarker driven FDA approved therapies as well as clinical trials. I do hope that the CED registry will have a low burden for patients and their treatment team.

Best Regards,
Sandeep Kodityal, MD
Assistant

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Konnick, M.D., M.S., FCAP, Eric Title: Assistant Professor
Organization: Department of Laboratory Medicine - University of Washington
Date: 01/17/2018
Comment:

17 January 2018

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

Ms. Jensen -

Thank you for the opportunity to comment on the draft national coverage determination (NCD) CAG-00450N related to the FoundationOne CDx (F1CDx) test.

I am a physician and practicing molecular pathologist in the Department of Laboratory Medicine at the University

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Luther, Sara Title: Regulatory Process Manager | Medicare Strategy Uni
Organization: Mayo Clinic
Date: 01/17/2018
Comment:

January 15, 2018

Ms. Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mail Stop #S3-02-01
7500 Security Boulevard
Baltimore, Maryland 21244
Submitted electronically

RE: Comments on Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

More

Melmeyer, Paul Title: Director of Federal Policy
Organization: National Organization for Rare Disorders
Date: 01/17/2018
Comment:

January 17, 2018

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

RE: Comment on NCD entitled “Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer” (CAG #00450N)

Dear Ms. Jensen,

On behalf of the 30 million Americans with one of the approximately 7,000 known

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Thompson, MD, Alexis Title: President
Organization: The American Society of Hematology (ASH)
Date: 01/17/2018
Comment:

January 17, 2018

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

RE: Proposed Decision Memorandum on Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG #00450N)

Dear Ms. Jensen,

The American Society of Hematology (ASH) is pleased to offer comments on the proposed decision memorandum on Next

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Waltman, Susan C. Title: Executive Vice President for Legal, Regulatory...
Organization: Greater New York Hospital Association
Date: 01/17/2018
Comment:

January 17, 2018   

                                                                             

Submitted Electronically

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

Re:   Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

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Stocum, Michael Title: CEO
Organization: Inivata
Date: 01/16/2018
Comment:

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

On behalf of Inivata, Inc., I sincerely appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) draft proposed National Coverage Decision of Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N). While we agree with the progressive decision to

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SoRelle, Jeff Title: Molecular Genetics Pathology Fellow
Organization: University of Texas Southwestern
Date: 01/16/2018
Comment:

Thank you for allowing me to comment on this important policy. I work as a Molecular Genetics Pathology Fellow at the University of Texas Southwestern Medical Center.

We recently brought on a new NGS assay for patients with advanced cancer (many of whom are Medicare beneficiaries based on their age). This assay was created with the highest levels of technical talent from the basic science research field. We also were able to expand a basic panel to a large one that will

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Freeman-Daily, Janet Title: Co-Adminstrator
Organization: The ROS1ders
Date: 01/16/2018
Comment:

Dear Centers for Medicare and Medicaid Services,

We applaud the effort made by the Centers for Medicare and Medicaid (CMS) to provide coverage of next generation sequencing (NGS) tests for cancer patients via the Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N). We understand the need to prevent patients being harmed by and money being wasted on inaccurate testing, and we are glad to see CMS attempt to create a

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Trahan, Phil Date: 01/16/2018
Comment:

On February 14 [PHI Redacted] will celebrate 5 years of relatively normal life with Stage 4 Non-Small Cell Lung Cancer driven by an ALK genetic rearrangement. While he is not near Medicare age I believe that CMS determinations affect his well-being, and the proposal to cover the Foundation One test is welcome news. However, the broad scope of the proposed policy should be reconsidered, particularly the lifetime limit of one NGS test per patient and the monopoly it grants to

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Barsan, Vali Title: Physician
Organization: UCSD
Date: 01/16/2018
Comment:

Dear Sir/Madam,

Thank you for your hard work in this extremely challenging and fast-paced field that remains critical for understanding the mechanisms behind each patient’s tumor (and, especially in the population you reference, their immune contexture). Prior to starting Fellowship in Pediatric Hematology-Oncology (effective July 2018), I have participated both in the engineering development of NGS tests and their clinical implementation through Molecular Tumor Board (including

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Martin, Mary Date: 01/16/2018
Comment:

I am a patient advocate with a family member who has stage IV lung cancer. Through genomic testing my family member was able to identify ALK+ biomarker and get targeted therapy that is significantly extending their quality of life and overall survival duration.

Thank you for the opportunity to provide comment on the National Coverage Analysis entitled ‘Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer’. We are grateful for advances in diagnostic

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Ladanyi, MD, Marc Title: Chief, Molecular Diagnostics Service
Organization: Memorial Sloan Kettering Cancer Center
Date: 01/16/2018
Comment:

January 16, 2018

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

Re: Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Administrator Verma:

Memorial Sloan Kettering Cancer Center (MSKCC) appreciates the

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Laboratory Directors, Academic Title: Directors/Leaders
Organization: 152 academic laboratory leaders at 59 different academic centers
Date: 01/16/2018
Comment:

We, the undersigned, are all physicians and/or certified directors or members of the leadership of molecular diagnostics laboratories at a group of academic medical centers nationwide. We write in concern about the “Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)”, and thank CMS for the opportunity to provide our comments. While it is reassuring to see that CMS agrees that oncology testing using NGS platforms merits

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Mitchell, Anthony Date: 01/16/2018
Comment:

[PHI Redacted]

Thank you for the opportunity to provide comment on the National Coverage Analysis entitled ‘Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer’. Cancer patients all over the country are benefitting from new knowledge in the genomic causes and drivers of cancer, as evidenced by increased access to personalized therapeutics and care based on the genetic makeup of cancer. We are grateful for advances in diagnostic

More

Press, Richard Title: MD, PhD; Professor of Pathology
Organization: Oregon Health & Sciences University
Date: 01/16/2018
Comment:

January 17, 2018

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

RE: Proposed Decision Memorandum on Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG #00450N)

Dear Ms. Jensen,

As a practicing molecular pathologist with significant research and clinical expertise in the molecular pathology of cancer,

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Qadan, Ammar Title: Vice President, Global Market Access
Organization: Illumina, Inc.
Date: 01/16/2018
Comment:

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

Re: CAG-00450N

Dear Ms. Syrek Jensen,

On behalf of Illumina, a leading developer and manufacturer of next generation sequencing (NGS) tools for both research and clinical use, we appreciate the opportunity to provide comments on the proposed National Coverage Determination (NCD) for NGS for

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LoBello, D.O., FCAP, Janine Title: Laboratory Director
Organization: Ashion Analytics
Date: 01/16/2018
Comment:

I write this letter to express grave concern over the recently drafted memo by CMS, which outlines proposed changes for clinical laboratories: Next Generation Sequencing (NGS) for Medicare Beneficiaries (CAG-00450N).

As the Laboratory Director of a CLIA-certified and CAP-accredited reference lab focused on NGS’s integration into the Precision Medicine movement in oncology, I see the proposed guidelines as being stifling on several, intertwining levels,

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Murphy, Hannah Title: Executive Director
Organization: Coalition for 21st Century Medicine
Date: 01/16/2018
Comment:

January 16, 2018

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

Re: Proposed Decision Memorandum for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Director Jensen:

On behalf of the Coalition for 21st Century Medicine (C21), we appreciate the opportunity to submit

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Alexander, Kristine Organization: The Regence Group
Date: 01/16/2018
Comment:

Thank you for the opportunity to offer our thoughts on this issue. The promise of personalized medicine has led to a proliferation of large NGS panels that offer tumor mutation profiling, such as the F1CDX™. These panels are intuitively attractive to use in clinical care because they can screen for numerous mutations within many genes quickly, and may lead to greater efficiency in the disease work-up. It is also possible that some of these “bundled” gene tests may be more cost

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Allen, Jeff Title: President and CEO
Organization: Friends of Cancer Research
Date: 01/16/2018
Comment:

Friends of Cancer Research (Friends) appreciates the opportunity to comment on the CMS “Proposed Decision Memo for Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer”. Next Generation Sequencing (NGS) is a very powerful technology platform for detection of multiple genetic alterations and has the potential to provide significant benefits to patients. The proposed coverage for NGS-based diagnostics is a step in the right direction that can positively impact

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Leone, Gustavo Title: Director
Organization: Hollings Cancer Center, Med Univ of SC
Date: 01/16/2018
Comment:

Comments on CMS’s Proposed NCD for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

As director of the Hollings Cancer Center at the Medical University of South Carolina, I appreciate the opportunity to comment on the proposed decision memo on Next Generation Sequencing for Medicare beneficiaries with advanced cancer. The concerns we outline below also include the perspectives of Dr. Steven Carroll, professor and chair of MUSC’s Department of

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Green, Sybil Title: Director, Coverage and Reimbursement
Organization: American Society of Clinical Oncology
Date: 01/16/2018
Comment:

January 16, 2018

Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
200 Independence Ave, S.W.
Washington, DC 20201

RE: Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Administrator Verma:

The American Society of Clinical Oncology (ASCO) is pleased to offer these comments in response to the proposed decision memo

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Jennings, Lawrence Title: Director, HLA and Molecular Diagnostics Lab
Organization: Ann & Robert H. Lurie Children's Hospital of Chicago
Date: 01/16/2018
Comment:

Like many academic laboratories, we offer lab-developed procedures for somatic variant detection, classification and clinical reporting. We are regulated under CLIA and although it is not FDA approved or cleared, the FDA has determined that such approval or clearance is not necessary.
The results of clinical testing at our laboratory are just as valid as those performed elsewhere. Moreover, by performing such testing in-house, we can continually improve testing to meet changing needs

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Sirohi, Deepika Date: 01/16/2018
Comment:
Clinical diagnostic molecular laboratories at academic medical centers are directed by very experienced and well trained physicians and laboratorians who provide high quality and most updated precision medicine based on next generation sequencing assays for oncology patients. Making NGS assays an FDA approved test, would impede the current practice and deny many patients with personalized oncology care. CMS should leave determination of coverage for NGS based assays flexible leaving room for

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Carroll, Merita Title: Founder
Organization: ALK Positive
Date: 01/16/2018
Comment:

My names is Merita Carroll and I am a [PHI Redacted] patient advocate with, and founder of ALK Positive, a support group for ALK-positive lung cancer patients (https://www.alkpositive.org/).

[PHI Redacted]

[PHI Redacted]

This can and will never happen under this new policy. I cannot believe Medicare is in the business of delivering a death blow to their patients. Please reconsider your position in this

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Bauer, Todd Title: MD
Organization: Tennessee Oncology / Sarah Cannon Research Institute
Date: 01/16/2018
Comment:

As a provider seeing a large volume of patients with advanced malignancies, I have the chance to experience, on a daily basis, the power of targeted therapies for patients with alterations that have been revealed by molecular profiling. From ALK, to ROS1, to TRK, finding these alterations leads to more effective and better tolerated therapies that otherwise would not be considered for these patients.

Patients benefit not just in quantity of life, but in quality of life and the

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Davis, Anjee Title: President
Organization: Fight Colorectal Cancer
Date: 01/16/2018
Comment:

January 17th, 2018

To: Centers for Medicare and Medicaid Services and Food and Drug Administration

To Whom It May Concern:

Fight Colorectal Cancer (Fight CRC), with input from members of our Medical Advisory Board, appreciates the opportunity to publicly comment on the proposed decision guideline for next generation sequencing (NGS) for Medicare beneficiaries with advanced cancer.

Fight Colorectal Cancer (Fight CRC) is the United States’ leading

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Wright, Brian Title: Director of Clinical Services
Organization: ArcherDX
Date: 01/16/2018
Comment:

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244
Re: NCD CAG-00450N

ArcherDX, Inc (ArcherDX) appreciates the opportunity to respectfully submit the following comments in response to the “Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer” National Coverage Analysis (NCD).

ArcherDX applauds insurers,

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Paulette, Tanya Title: RN
Organization: Centra Lynchburg Hematology Oncology
Date: 01/16/2018
Comment:
I am urging you to commend the recent decision by the FDA to approve Foundation Medicine's comprehensive cancer diagnostic test, Foundation One CDx, and the proposed decision by CMS to reimburse on a national basis for this, and other Next Generation Sequencing cancer diagnostic tests that meet the suggested criteria. Many cancer patients suffer needlessly and pass away because of the difficulty in identifying the most effective therapy for cancer. Patients need access for genomic testing s

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Tomaszewicz, Keith Title: Labatory Manager
Organization: Umass Memorial Medical Center
Date: 01/16/2018
Comment:

Title: Laboratory Manager
Organization: UMass Memorial Medical Center, Diagnostic Molecular Oncology Lab
Date: 1/16/2018

As a laboratory manager in molecular diagnostics, I have concerns about the negative impact I foresee with the CMS proposed national coverage determination (NCD) for next generation sequencing. I have had the privilege to be heavily involved with our in-house NGS implementation, which has proven to be a powerful tool for Oncologists, Pathologists, and

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Tsongalis, Gregory Title: Professor and Director
Organization: Dartmouth Hitchcock Medical Center
Date: 01/16/2018
Comment:

January 17, 2018

Ms. Seema Verma
Administrator
Centers for Medicare & Medicaid Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W., Room 445-G
Washington, DC 20201

BY ELECTRONIC DELIVERY

Re: CAG-00450N – Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

Dear Ms. Verma:

Dartmouth-Hitchcock Health is pleased to submit comments on the Centers for

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Boling, Ellen Title: Registered Nurse
Organization: Centra Lynchburg Hematology Oncology
Date: 01/16/2018
Comment:
I am urging you to commend the recent decision by the FDA to approve Foundation Medicine's comprehensive cancer diagnostic test, Foundation One CDx, and the proposed decision by CMS to reimburse on a national basis for this, and other Next Generation Sequencing cancer diagnostic tests that meet the suggested criteria. Many cancer patients suffer needlessly and pass away because of the difficulty in identifying the most effective therapy for cancer. Patients need access for genomic testing so

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Gagan, Jeffrey Title: MD, PhD
Organization: Brigham and Women's Hospital
Date: 01/16/2018
Comment:

Dear CMS,

I am Dr. Jeffrey Gagan, MD, PhD, Molecular Genetic Pathology Fellow at Harvard Medical School. Thank you for the opportunity to provide comments on the proposed NCD for NGS assays in advance cancer patients.

During my relatively brief time in medical training, I have already witnessed several large paradigm shifts in how we approach DNA sequencing in oncology. While I agree that the traditional framework of an LDT may not be sufficient to regulate the clinical use

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Addario, Bonnie J. Organization: Bonnie J. Addario Lung Cancer Foundation
Date: 01/16/2018
Comment:

January 16, 2018

The Honorable Scott Gottlieb, MD
Commissioner
Food and Drug Administration
10903 New Hampshire Avenue, Room 2217
Silver Spring, MD 20993

Ms. Seema Verma
Administrator
Centers for Medicare and Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Commissioner Gottlieb and Administrator Verma:

As a patient founded, patient driven and patient led organization the Bonnie J. Addario Lung Cancer

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Carlson, MD, Robert W. Title: Chief Executive Officer
Organization: National Comprehensive Cancer Network
Date: 01/16/2018
Comment:

January 12, 2018

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

RE: Proposed Decision Memorandum for National Coverage Analysis (NCA) for Next Generation Sequencing (NOS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Jensen:

The National Comprehensive Cancer

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Chandra, DO, FCAP, FASCP, Pranil K. Title: Vice President and Chief Medical Officer
Organization: Genomic and Clinical Pathology Services, PathGroup
Date: 01/16/2018
Comment:

January 16, 2018

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244
Submitted via email: tamara.syrekjensen@cms.hhs.gov and CAGinquiries@cms.hhs.gov.

Dear Ms. Jensen,

PathGroup is pleased to provide comments to the proposed draft National Coverage Determination (NCD) for next generation sequencing in Advanced Cancer

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Franklin, LGSW, A CSW, Elizabeth Title: Executive Director, Cancer Policy Institute
Organization: Cancer Support Community (CSC)
Date: 01/16/2018
Comment:

January 16, 2018

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

RE: Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Director Syrek-Jensen:

On behalf of the Cancer Support Community (CSC), an international nonprofit organization that provides support,

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Patel, Sandip Date: 01/15/2018
Comment:
Would consider allowing cfDNA (cell-free DNA, liquid biopsy) as permissible for reimbursement
Nieva, Jorge Title: Dr.
Organization: USC/Norris Cancer Center
Date: 01/15/2018
Comment:
I am concerned about the limitation in the draft policy with regard to repeat testing. For patients with EGFR mutated lung cancer, the standard of care is to retest for new mutations in the tumor that may be driving treatment resistance. This may need to be done more than once and the same technology should be covered.
barnhart-hinkle, blair Title: Director, Government Relations
Organization: Cleveland Clinic
Date: 01/15/2018
Comment:

Cleveland Clinic (CC) is a not-for-profit, integrated healthcare system dedicated to patient care, teaching, and research. Our health system is comprised of a main campus, 10 community hospitals, and 21 family health centers with over 3,500 salaried physicians and scientists. Last year, our system had more than seven million patient visits and over 220,000 hospital admissions. We appreciate the dedication of the Agency staff on behalf of the Medicare Program and the work they devote to its

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Williams, Casey Title: Director
Organization: Avera Cancer Institute
Date: 01/15/2018
Comment:
I applaud the FDA and CMS for their leadership in bringing NGS testing to more patients with advanced cancer in the United States. In our program, we routinely use NGS to further evaluate advanced patients for additional treatment options, including subsequent lines of therapy and appropriate clinical trials. The ability to order these tests and not constantly worry about the administrative process and potential lack of insurance coverage is a significant step forward. It is my hope that

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Bale, Allen Title: Professor of Genetics
Organization: Yale University
Date: 01/15/2018
Comment:

Among the key roles of the FDA is “… advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health (FDA Mission Statement, 2017).

Many of my colleagues have already pointed out the negative effects of this regulation on innovation, patient care, and medical costs.

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Pfau, Ruthann Title: Clinical Laboratory Director
Organization: Institute for Genomic Medicine
Date: 01/15/2018
Comment:

To The CMS Coverage Determination Panel:

Thank you for the opportunity to comment on the document "Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)".

I write to you from a clinical services laboratory within an academic medical center, where we practice CLIA-licensed, CAP-certified, clinical standard-of-care oncology testing using next generation sequencing (NGS) as a basic clinical service. This

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Buckner, M.D., Jan Title: Chair, Department of Oncology
Organization: Mayo Clinic
Date: 01/15/2018
Comment:

January 12, 2018

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

Dear Ms. Jensen:

Background:
In association with the approval of the Foundation One Companion Dx under parallel review, CMS issued a National Coverage Analysis for the use of NGS-based tests in patients with advanced cancer.

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Cosgrove, Jennifer Date: 01/14/2018
Comment:

To Whom it May Concern:

[PHI Redacted]

It has come to my attention that CMS is thankfully recognizing the value of precision diagnostics in the care of cancer patients by proposing coverage for FoundationOne CDx (F1CDx). I am in favor of a positive coverage determination for the product reviewed in the Parallel Review program, F1CDx. I am, however, disappointed to learn that under a new policy some cancer patients will be limited to only one (1) test per

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Silberger, Julie Date: 01/14/2018
Comment:

Thank you for the opportunity to comment on the NGS coverage for Medicare beneficiaries. NGS is a critical tool in the personalized management of cancer; however, I am concerned that your proposal only covers one NGS test per lifetime.

Cancer patients typically require re-testing upon disease progression, and this often occurs multiple times as the cancer continues to mutate. And as new targets for treatment become available in the cancer field, additional opportunities open up

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Cushman-Vokoun, Allison Title: Medical Director Academic Molecular Diagnostic Lab
Date: 01/14/2018
Comment:

January 14, 2018

Ms. 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

Dear Ms. Jensen,

I am writing to you regarding CAG-00450N on behalf of myself, an academic molecular pathologist and medical director of a CLIA-certified, CAP-accredited molecular diagnostics laboratory that serves a large midwestern

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anderson, ian Title: md
Organization: st joseph health care
Date: 01/14/2018
Comment:
I am submitting comments to support the preliminary NCD that CMS has posted with intent to help patients with advanced cancer.
I applaud the Agency for this key step forward in expanding precision medicine into the cancer arena. It bolsters our collective goal of leveraging our proven knowledge of cancer genomics to finding new, more effective treatments for various forms of this disease.
High-quality, broad molecular profiling identifies more patients for biomarker-driven,

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Ewalt, Mark Title: Assistant Professor
Organization: University of Colorado
Date: 01/14/2018
Comment:

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

Re: CAG-00450N (NGS for Medicare Beneficiaries with Advanced Cancer)

Dear Ms. Syrek Jensen:

I am writing to you as an academic molecular pathologist and concerned citizen regarding the draft NCD for Next Generation Sequencing (NGS) in oncology. I am writing as an individual and my

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Merritt, Brian Title: Assistant Professor
Organization: Baylor College of Medicine
Date: 01/14/2018
Comment:
As an academic molecular pathologist, I am against this NCD proposal. By tying all future reimbursement for NGS-based tests to FDA approval, this creates a novel and extremely burdensome additional laboratory oversight regime that is not consistent with current legislation and which is incompatible with the continued practice of personalized care and laboratory medicine at a local level. Academic NGS diagnostic laboratories provide high-quality and heavily-regulated services that are valuable,

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Hollenbeck, Gina Date: 01/13/2018
Comment:

o whom it may concern;

[PHI Redacted]

Thank you for the opportunity to provide comment on the National Coverage Analysis entitled Next Generation Sequencing (Cancer patients all over the country are benefitting from new knowledge in the genomic causes and drivers of cancer, as evidenced by increased access to personalized therapeutics and care based on the genetic makeup of cancer. I am so grateful for advances in diagnostic technologies, such as NGS as it

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Jones, Dan Organization: Columbus, OH
Date: 01/13/2018
Comment:

This draft LCD clearly reflects the efforts of a single commercial genomics laboratory, working with CMS, to limit access to NGS testing for business reasons.

As someone who has worked at a high level both in commercial laboratories and academic genomics laboratories for many years, I know that when purely commercial considerations alone drive policy, patients are harmed.

A large number of operational factors, financial constraints and access issues affect whether patients

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Hall, Kathryn Title: Molecular Technologist
Organization: Colorado Molecular Correlates
Date: 01/12/2018
Comment:

My name is Kathryn Hall, and I am a Molecular Technologist at Colorado Molecular Correlates (CMOCO) at the University of Colorado Anschutz Medical Campus.

Thank you for the opportunity to provide you with feedback regarding your proposed National Coverage Determination.

CMOCO is a molecular diagnostics laboratory in the field of Precision Medicine, and our emphasis is primarily in solid tumor cancer samples (although we expanding into germline and heme-based assays). My

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Anthony, Douglas Title: Physician and Professor
Date: 01/12/2018
Comment:

Dear Colleagues,

The proposed national coverage determination concerning next generation sequencing is going to hurt patients and hurt medical care in the United States, and I sincerely hope the Centers for Medicare and Medicaid Services will eliminate further consideration of this plan.

My opinion is based on my expertise as a physician who specializes in laboratory testing, a medical director of a large clinical laboratory performing over 10 million tests per year, and a

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Sanford Biggerstaff, Julie Title: Laboratory Medical Director
Organization: Idaho Cytogenetics Diagnostic Laboratory
Date: 01/12/2018
Comment:
I am writing in opposition to the current proposal for oversight by the FDA of laboratory developed tests in the NGS/genomics area. This is a fast-moving field and this puts an onerous burden on any laboratory, but particularly smaller and academic laboratories, to ensure that tests are described and listed, not to mention that as tests are changed in the laboratory, the registration of the test is also updated. Please understand that the human genome contains approximately 30,000 genes,

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Yohe, Sophia Title: Assistant professor
Organization: University of Minnesota
Date: 01/12/2018
Comment:

CLIA '88 laws allow laboratories to develop in-house tests for patient care. These laboratory-developed tests (LDTs) are widely used at academic center and community labs for standard patient care, including making diagnoses and helping manage patients on standard-of-care approved medications. This basic clinical service is currently being performed in labs across the country for cancer patients and often uses NGS technologies. As clinical labs, any LDT (including NGS based tests)

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Lutz, Charles Title: Director, Division of Cell and Molecular Pathology
Organization: University of Kentucky
Date: 01/12/2018
Comment:
I am in favor of policies that allow university clinical laboratories to continue to offer NGS testing to their cancer patients. Policies that restrict access to this testing to companies with enough money to go through regulatory hurdles are bad. These companies are NOT transparent with their testing protocols and take a paternalistic "trust us" attitude. This does not allow individual physicians to evaluate exactly what they are getting for their patients.
Leyland-Jones, Brian Title: VP Avera Center for Precision Oncologyj
Organization: Avera Cancer Institute
Date: 01/12/2018
Comment:

* Above all, thanks for everything that FM has contributed to our patients, and for the multiple extra years of life that your genomic testing has contributed.”

* We have Stage 2, 3 and 4 patients in their 20’s, 30’s and 40’s, whose lives have been transformed by your testing.

Starostik, Petr Title: Director, Molecular Pathology
Organization: University of Florida
Date: 01/12/2018
Comment:

CAG-00450N

I direct a clinical molecular pathology laboratory at the College of Medicine of the University of Florida in Gainesville, FL. The laboratory is CLIA- certified as required for any type of clinical laboratory work and we are using our own laboratory-developed tests to run NGS-based mutation profiling assays for the most frequent cancer types one can see in the associated UF teaching hospital and the surrounding Florida area.

I follow actively the development of

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Wilcox, William Title: Professor of Human Genetics
Organization: Emory University School of Medicine
Date: 01/12/2018
Comment:

The march of CMS to require FDA approval for NGS tests is foolish. The field moves too fast.

In this particular case, requiring FDA approval for molecular NGS testing will unnecessarily slow down the clinical application of advances in research and result in needless deaths. How long would it take to get FDA approval to include a new gene that could be a major, targetable driver for that particular cancer? The whole idea behind personalized medicine is to identify the specific

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Kurzrock, Razelle Title: Senior Deputy Center Director
Organization: UC San Diego Moores Cancer Center
Date: 01/12/2018
Comment:

Tamara Syrek-Jensen, JD
Director, Coverage and Analysis Group

Joseph Chin, MD, MS
Deputy Director, Coverage and Analysis Group

Katherine B. Szarama, PhD
Lead Analyst
katherine.szarama@cms.hhs.gov

RE: CAG-00450N Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

Dear Ms. Syrek-Jensen and Drs. Chin and Szarama:

We applaud this National Coverage Decision (NCD), it is

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Barton, Colin Date: 01/12/2018
Comment:

[PHI Redacted]

Thank you for the opportunity to provide comment on the National Coverage Analysis entitled ‘Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer’.

Cancer patients all over the country are benefiting from new knowledge in the genomic causes and drivers of cancer, as evidenced by increased access to personalized therapeutics and care based on the genetic makeup of cancer. We are grateful for advances in diagnostic

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Jensen, MD, Roy A. Title: Director
Organization: The University of Kansas Cancer Center
Date: 01/12/2018
Comment:

TO: Centers for Medicare & Medicaid Services

FROM: Roy A. Jensen, MD

DATE: January 12, 2018

RE: Proposed Decision Memo on Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer NCD (CAG-00450N)

My name is Roy Jensen, MD, director of The University of Kansas Cancer Center. I would like to thank the Centers for Medicare and Medicaid Services for the opportunity to comment on the Proposed Decision Memo on Next Generation Sequencing for Medicare

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Nelson, M.D., Ph.D., Andrew C. Title: Assistant Professor
Organization: University of Minnesota
Date: 01/12/2018
Comment:

January 11, 2018

Tamara Syrek Jensen
Department of Laboratory Medicine & Pathology
Director, Coverage and Analysis Group
Center for Medicare & Medicaid Services
Mail stop# 53-02-01
7500 Security Boulevard
Baltimore, MD 21244

Dear Ms. Jensen-

My colleagues and I appreciate the open comment period to express our concerns with the Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced

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Ramsey, M.D., Paul G. Title: CEO, UW Medicine
Organization: University of Washington
Date: 01/12/2018
Comment:

January 12, 2018

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

Dear Ms. Jensen,

Thank you for the opportunity to comment on the draft national coverage determination (NCD) CAG-00450N related to the FoundationOne CDx (FlCDx) test.

UW Medicine provides high-complexity medical care for patients from Washington State and across the Pacific

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Schoenborn, Margot Title: Chief Administrative Officer & General Counsel
Organization: OmniSeq, Inc.
Date: 01/12/2018
Comment:

January 12, 2018

BY US MAIL & EMAIL
Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop #S3-02-01
7500 Security Boulevard
Baltimore, Maryland 21244
Tamara.Syrekjensen@cms.hhs.gov

Re: Comment on Proposed CAG-00450N

Dear Ms. Jensen:

Please accept the following comments of OmniSeq, Inc. on the proposed decision memorandum for Next

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Skacel, Marek Title: Director, Molecular Pathology Laboratory
Organization: Dahl-Chase Pathology Associates
Date: 01/11/2018
Comment:

Dear CMS representative,

We are writing to you from an independent molecular pathology laboratory operating in one of the more rural areas of the US, central and northern Maine regions.
We serve 15 regional hospital clients and numerous outpatient facilities within the state.

The above ruling you are currently considering would limit next generation sequencing (NGS) to assays that have received FDA approval. That decision would limit this testing to few laboratories in

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Shepard, Gregg Title: MD, Medical Oncology
Organization: Tennessee Oncology
Date: 01/11/2018
Comment:
I am concerned that this will limit patient access to cutting edge and timely care for advanced cancer. The requirements that the NGS be performed only in patients enrolled in an existing trial is not practical. Often the purpose of the GNS test is to see IF the cancer is approprate for treatment as part of a trial, but this is only known after the results are available. The requirement for the test to be done at a site that enrolls patients in registry with konwn clinical data will

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Mahajan, Vinay Date: 01/11/2018
Comment:
I am a Molecular Pathologist at the Brigham and Women's Hospital, and am strongly opposed to the decision. NGS sequencing has been the primary driver of the exponential growth in our understanding of tumor-driving mutations, and has proven enormously consequential for tumor diagnosis and therapy. Sequencing technology that is only a few years old is already insufficient to meet clinical demands. In this environment, it is vital to maintain and develop the clinical laboratory infrastructure in

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Brumsted, MD, John R. Title: President and Chief Executive Officer
Organization: University of Vermont (UVM) Health Network
Date: 01/11/2018
Comment:

Submitted via email to CAGinquiries@cms.hhs.gov

January 11, 2018

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

Re: Proposed Decision Memo for Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer CAG-00450N

Dear Sir/Madam:

I am submitting these comments on behalf of the

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Nolte, Frederick Title: Professor, Pathology and Laboratory Medicine
Organization: Medical University of South Carolina
Date: 01/10/2018
Comment:

My name is Frederick S. Nolte, PhD and I am a Professor of Pathology and Laboratory Medicine, Vice-chair for Laboratory Medicine, and Director of Molecular Pathology at the Medical University of South Carolina. Our clinical laboratories provide diagnostic services including NGS tests for patients with advanced cancer seen at our Hollings Cancer Center, a NCI designated cancer center. I am grateful to CMS for the opportunity to comment on the proposed NCD for NGS for Medicare Beneficiaries

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Wanjari, Pankhuri Date: 01/10/2018
Comment:
I work at an academic hospital lab where I analyze NGS data for cancer patients. These methods are clinically validated and are used for basic diagnosis and decision-support for standard approved therapies. It is a great experience working with physicians and pathologists and making significant contributions in personalized oncology clinical care. The proposed NCA will create a testing monopoly which is not good for national cancer care support network.
khandekar, janardan Title: Director Center for molecular Medicine
Organization: Northshore University healthSystem
Date: 01/10/2018
Comment:

It is now widely accepted that for optimum evaluation and therapy for cancer, it is essential that physicians, other healthcare workers and patients need to know site of origin as well as molecular drivers of cancer. Without complete molecular characterization of every cancer seen in hospitals, physician's offices one can not design plan for treatment of that cancer patient.

Molecular testing is rapidely evolving and understandably there is concern about proliferation of tests

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Eisenberg, Rebecca Title: Robert & Barbara Luciano Professor of Law
Organization: University of Michigan Law School
Date: 01/10/2018
Comment:

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

Re: NCD CAG-00450N

Dear Ms. Syrek Jensen,

We recently published a Policy Forum in Science encouraging more widespread insurance coverage, including coverage with evidence development (CED), for genomic testing of tumor DNA. [R Eisenberg & H Varmus (2017) Insurance Coverage for broad genomic tests in

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Patil, Sushant Title: Bioinformatician
Organization: University of Chicago Medicine
Date: 01/10/2018
Comment:
I work at an academic hospital lab. My full time work involves data analysis from standard-of-care NGS testing for cancer patients that are used for basic diagnosis and decision-support for standard approved therapies. I enjoy working closely together with physicians and pathologists to participate in personalized oncology clinical care. The proposed NCA will create a testing monopoly which is not good for national cancer care support network.
Hill, Charles Title: Director, Molecular Diagnostics Laboratory
Organization: Emory University Hospital
Date: 01/10/2018
Comment:
As a practicing molecular pathologist, I am concerned that the proposed national coverage determination will have a negative impact on patient care. Academic medical centers have developed the technologies and practice guidelines used by for-profit companies to submit for FDA approval. The proposed payment determination will slowly exclude these same centers from continuing to perform these tests due to their inability to be reimbursed for their efforts. Typical non-profit academic centers do

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Dolderer, Daniel Title: MD
Organization: UC Davis Medical Center
Date: 01/09/2018
Comment:

NGS oncology testing at academic centers and other labs is standard of care, for making basic diagnoses and to help manage patients on standard-of-care approved medications. Patients depend on these tests being readily available in order to get diagnosed and treated. They should be covered for most cancers, newly discovered or recurrent.

The coverage determination will produce a monopoly and jeopardizes the solvency of hundreds of NGS labs at academic centers and beyond by

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Bien-Willner, Gabriel Title: MD, PhD
Organization: Bien-Willner Physicians Grp PA
Date: 01/09/2018
Comment:

Oncology practice is at a crossroads. Although it has long been known that cancer is a genetic disease, we did not in the past have the resources or technology to study the causes of cancer for an individual patient. For simplicity’s sake, we supported the mantra of “one biomarker for one disease” although always realizing that reality is far more complicated. Now, with Next-Gen sequencing (NGS) technology, for the first time we really CAN understand what is driving the tumor, not in a

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phillips, Dorothy Title: Executive Director
Organization: Florida Society of Clinical Oncology
Date: 01/09/2018
Comment:

On behalf of the 3,000 members of the Florida Society of Clinical Oncology, we are pleased to offer the following comments.

Cancer care is evolving rapidly and personalized care is helping patients tolerate therapy and is improving outcomes.

With advances in genomic molecular profiling, physicians make better treatment decisions which provide a better quality of life and improved survival to their patients.

FLASCO, as an advocate for cancer patients in

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weichert, regina Title: Mrs
Date: 01/09/2018
Comment:

My name is Regina charlotte Weichert, I am from Texas,USA. I am sure this information will be useful to the general public on how [PHI Redacted] was cured from Ovarian cancer with herbal medication administered by Dr Zulu. He cures other diseases too. For further information visit www.zuluherbalremedy.com. For those of us that would come back appreciating me or might need further information, the above name is my facebook name or feel free to reach me on my cellphone

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Meropol, MD, Neal J. Title: Vice President of Research Oncology
Organization: Flatiron Health
Date: 01/09/2018
Comment:

January 9, 2018

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

Re: NGS for Medicare Beneficiaries with Advanced Cancer NCD CAG-00450N

Dear Ms. Jensen,

Flatiron Health is a leading health information technology company with a goal of improving cancer care through software solutions applied to clinical care and research.

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lee, susan Date: 01/08/2018
Comment:
With the advent of Precision Medicine and its success in finding and treating various stage cancers AND the development of reliable blood and tumor biopsy NGS it is time to embrace change. Cancer patients are benefiting greatly by the information NGS provides allowing them to return to their lives after a major cancer diagnosis. As cancer finds a way to continue to grow after periods of quiet —NGS also helps patients and doctors select treatments that look most promising or avoid

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Pac, Lincoln Title: Resident Physician
Organization: University of Washington
Date: 01/08/2018
Comment:
As a resident physician training to become a molecular pathologist, I am highly concerned that requiring FDA-approval for payment of NGS testing for advanced cancer patients will severely limit access to this diagnostic resource for my patients. The barrier to obtaining FDA-approval for many high-quality, validated NGS tumor panels will restrict research to improve quality and clinical utility in the academic centers that are driving the advancement of this technology. Many payers will likely

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Mroz, Pawel Title: Assistant Professor
Organization: University of Minnesota
Date: 01/08/2018
Comment:
I am writing to express my strongest opposition of this proposed scheme. The CMS should spend more time to familiarize itself with scientific facts and the numerous publications that are out there that provide ample scientific evidence that the proposed scheme is damaging to the patients, and will jeopardize the existence of academic and small private molecular diagnostic laboratories and stall progress of this continuously developing and expanding field. It is frankly staggering and

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Kwiatkowski, MD, PhD, David Title: Professor Medicine, Senior Physician
Organization: Harvard Medical School, Brigham and Women's Hospital
Date: 01/08/2018
Comment:

Dear sir/madam:

I am David J. Kwiatkowski, MD, PhD, Professor of Medicine at Harvard Medical School, and Senior Physician, Brigham and Women’s Hospital. I am the Program Leader of the Cancer Genetics Program at Dana Farber - Harvard Cancer Center. I have been a practicing oncologist for 35 years.

I appreciate the opportunity to comment on the proposed NCD, Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.

I am an oncologist and

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Jahanzeb, Mohammad Organization: University of Miami Sylvester Comprehensive Cancer Center
Date: 01/07/2018
Comment:
As an oncologist taking care of patients with lung cancer or breast cancer, I applaud the agency for taking steps to make NGS available to patients, facilitating matching the right patient to the right drug at the right time. I hope such testing will become routine and that the administrative burden of getting coverage will be kept low
Andrade, Melissa Date: 01/06/2018
Comment:
Preventing NGS LDT assays from receiving Medicare reimbursement does not benefit our patients. As the manager of the Clinical Molecular Laboratory in a Major Academic Medical Center, I condemn the idea that our validated assays are not as worthy of reimbursement as an FDA approved assay.
FDA approval is time consuming and expensive. Hospital laboratories do not have the capacity or funding to attempt the FDA approval process. What we have been granted legally in CLIA '88 is the ability

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Graham, Ann Title: Founder & President
Organization: MIB Agents Osteosarcoma Alliance
Date: 01/06/2018
Comment:

Thank you for your interest and perseverance in pursuing information and Medicare approval for NGS in people with advanced cancers.

As a patient of a rare cancer (osteosarcoma), with multiple and varied genomic mutations possible within the disease, [PHI Redacted] would have benefitted from knowing which marker to target (if it were available). The efficacy of targeting can only be done by those who are willing to go before us in receiving in vivo therapies. The

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Kadri, Sabah Title: Director of Bioinformatics
Organization: University of Chicago
Date: 01/05/2018
Comment:
I have been working at the University of Chicago doing clinical testing in cancer for almost 4 years. We are an academic hospital lab providing high-quality patient care through standard-of-care NGS testing for cancer patients, and have made a huge difference to the lives of thousands of patients since our lab was founded in 2013. I work closely with physicians as well as pathologists as we contribute to personalized oncology clinical care. We hold all our tests to the highest standards and

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Davies, Kurtis Title: Instructor
Organization: University of Colorado
Date: 01/05/2018
Comment:

Thank you very much for the opportunity to provide comments on the NCA proposal. I work as the Lead Assay Development Scientist in the laboratory at the University of Colorado that provides next-generation sequencing based analysis of solid tumor samples for our hospital.

First, I would like to emphasize the high standards that my laboratory adheres to and the extensive quality control procedures that we have in place. I believe that the proposed coverage determination would only

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Patel, Nimesh Date: 01/05/2018
Comment:
I am currently a molecular lab director at an academic institution. The current wording for the NCD indicated that the NGS test must be an FDA-approved companion in vitro diagnostic. This determination will benefit companies offering such testing, but will greatly limit patient access to important and time-sensitive testing and associated therapies. Studies have shown that laboratory-developed tests can be as sensitive and specific as FDA-approved testing. In addition, labs performing testing

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Hinrichs, Steven Title: Professor and Chair
Organization: UNMC
Date: 01/05/2018
Comment:

I am writing to share my opinion that the proposed CMS decision on NGS will have a major negative impact on Medicare beneficiaries and could cause them to be excluded from important cancer treatments.

The decision to acknowledge the value of NGS (criteria # 1) is correct, however the inclusion of only FDA approved tests (criteria # 2) and test reports is badly flawed policy. I would be pleased to provide more complete testimony should CMS seek additional input to fix the proposed

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Nelson, Andrew Title: MD, PhD
Organization: University of Minnesota
Date: 01/05/2018
Comment:

Thank you for the opportunity to comment on the Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N). I strongly oppose this National Coverage Determination (NCD) because the scope is too broad and will have potentially disastrous consequences on the care of advanced cancer patients in the United States.

I am an academic attending physician (M.D./Ph.D.) board certified in both Molecular Genetic Pathology and Anatomic

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Kim, MD, PhD, Annette S. Title: Associate Professor, Harvard Medical School
Organization: Brigham & Women's Hospital
Date: 01/05/2018
Comment:

Dear CMS,

I am Dr. Annette S. Kim, MD, PhD, Associate Professor, Harvard Medical School, and Assistant Director of the Center for Advanced Molecular Diagnostics at Brigham and Women's Hospital. I am also on the Board of the Association of Molecular Pathology and serve on the College of American Pathologist Molecular Oncology Committee. Thank you for the opportunity to provide comments on the proposed NCD for NGS assays in advance cancer patients.

With the approval of NGS

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Perkins, Sherrie L. Title: Chief Exexutive Officer
Organization: ARUP Laboratories
Date: 01/05/2018
Comment:

January 5, 2018

Administrator Seema Verma
Centers for Medicare and Medicaid Services

RE: Centers for Medicare & Medicaid Services (CMS) Proposed National Coverage Determination for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

Dear Administrator Verma,

Thank you for the opportunity to comment on the “Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

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Stewart, Alexander Title: MBChB
Organization: Mayo Clinic
Date: 01/04/2018
Comment:
I am the director of individualized medicine (genomic or precision medicine) at Mayo Clinic and a practicing hematologist with expertise in treating multiple myeloma. This highly restrictive "FDA only" policy will dramatically reduce patient access to highly important genomic information about there tumor which has significance for prognosis, therapeutic selection, drug resistance and clonal diversity. It is a regressive and poor policy that should not be pursued in a country with high

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Gish, Jane Date: 01/04/2018
Comment:
NGS sequencing should be covered by Medicare as it will make treatment more efficient by showing which targeted medications can benefit certain patients, and will also make treatment less burdensome as it will be more targeted.
Lin, Suh-Ling Date: 01/04/2018
Comment:
It is essential for Medicare to cover NGS testing to benefit Medicare patients!!
Weisberger, M.D., James Title: Executive Vice President, Clinical
Organization: BioReference Laboratories, Inc.
Date: 01/04/2018
Comment:

VIA E-MAIL

January 4, 2018

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

Re: Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Director Jensen,

We are writing to comment on the Proposed Decision Memorandum for Next Generation Sequencing (NGS) for Medicare

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Hui, Kar Date: 01/03/2018
Comment:

As part of Team SURVIVEiT, a nonprofit patient advocacy that provides hope, knowledge, and resources crucial to surviving cancer, we want to commend the FDA and CMS on their efforts to expand Medicare coverage of this potentially life-saving test to more patients. Comprehensive genomic profiling achieved through the FoundationOne CDx test, assesses all classes of genomic alterations in 324 genes known to drive cancer growth. This testing provides potentially actionable information to help

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Stabler, Janis Date: 01/03/2018
Comment:
This should be passed quickly to allow for better diagnosis and tailored treatment.
Grossman, Ph.D., Hildy Title: President and Founder
Organization: Upstage Lung Cancer
Date: 01/03/2018
Comment:
I am writing as a lung cancer patient advocate who heads a non-profit lung cancer organization.
Upstage Lung Cancer supports increased coverage by Medicare and other insurance companies for NGS.
I know first hand how beneficial this kind of testing can be in helping determine targeted therapies for cancer patients.
This information can make a difference in saving or losing lives.
Insurance providers offer an entry point for more patients to get this important

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Kayali, Fadi Date: 01/03/2018
Comment:
High-quality, NGS profiling help in our treatment decision and enrolling patient in clinical trial. This is a very good step in precise medicine. We are encouraged that there is a clear path for coverage for all tumor types, either through full coverage or through coverage with evidence development (CED). The coverage is applicable for both solid tumor and liquid biopsy.
Sang, Charles Title: Senior Vice President, Diagnostics
Organization: Adaptive Biotechnologies
Date: 01/03/2018
Comment:

Adaptive Biotechnologies appreciates the opportunity to comment on CMS’ proposed national coverage determination (NCD) as described in the National Coverage Analysis for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.

The clonoSEQ® Assay is an in vitro diagnostic assay which is performed as a laboratory service provided by Adaptive Biotechnologies. It utilizes next-generation sequencing (NGS or high-throughput sequencing, HTS) to identify,

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Hussein, Maen Title: MD
Organization: Florida Cancer specialists
Date: 01/03/2018
Comment:
this is the future, this is personalized care, I strongly believe those tests should be covered my Medicare at the end it will provide information leading to more cost effective treatments, improve quality of life and avoid unnecessary regimens.
it already has proven its place in treating many patients in my practice..
Mason, MBA, Whitney Organization: Intermountain Precision Genomics
Date: 01/03/2018
Comment:

While Intermountain Precision Genomics (IPG) is supportive of streamlining the approval and coverage processes for in vitro diagnostics, we have several concerns we would like to voice about the proposed National Coverage Determination (NCD).

IPG commends CMS for their recognition of the value of precision medicine in the care of cancer patients as evidenced by the proposed NCD. However, the draft NCD proposes a coverage policy that has ramifications far beyond the Foundation

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Sireci, MD, MS, Anthony N. Title: Assistant Professor of Pathology and Cell Biology
Organization: Columbia University
Date: 01/03/2018
Comment:

January 3, 2018

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

Re: NCD CAG-00450N

Dear Ms. Syrek Jensen,

We are a group of Medical Directors and Molecular Pathologists from large, academic medical centers in New York State who will be affected by the recent parallel approval announced by FDA and CMS for Foundation Medicine's

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Sahid, Judith Date: 01/02/2018
Comment:
I strongly agree that Medicare coverage should be offered for NGS.
Wright-Browne, Vance Date: 01/02/2018
Comment:
As a community Oncologist who on a daily basis, faces patients desperate for effective treatments Foundation Medicine testing guides us not only in selecting potentially more effective treatments but informs us also on therapies that might not be effective. Acknowledging that the science of Cancer Genomics continues to rapidly unfold, we would be remiss not to exploit every opportunity utilize available technology to enhance every patient's opportunity to benefit, and minimize, potential harm

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Fernandes, Helen Organization: Columbia University Laboratory of Personalized Genomic Medicine
Date: 01/02/2018
Comment:

December 21, 2017

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

Re: NCD CAG-00450N

Dear Ms. Syrek Jensen,

We are a group of Medical Directors and Molecular Pathologists from large, academic medical centers in New York State who will be affected by the recent parallel approval announced by FDA and CMS for Foundation Medicine’s FoundationOne

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Figueras, Anita Date: 01/02/2018
Comment:

I support the proposal for Medicare reimbursement for Next Generation Sequencing, and urge the Centers for Medicare and Medicaid Services to grant approval.

If Next Generation Sequencing is used as a companion test for patients with advanced cancer for whom targeted treatments may be available, both doctors and patients will begin treatment with information that may well help guide treatment decisions both in the near term and in the future. A specific example: researchers have

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Anastasia, Elizabeth Date: 01/02/2018
Comment:

I support the proposed changes in Medicare to provide coverage for NGS testing for beneficiaries with advanced cancer.

[PHI Redacted]

The data gleaned from these types of test will aid in crucial research aimed at finding the appropriate targeted medications for [PHI Redacted] and others who suffer from advanced stage cancers.

Thank you for considering this important change to the CMS rules.

Beth Anastasia

McCleod, Michael Title: DO
Organization: Florida Cancer Specialists
Date: 01/02/2018
Comment:

I applaud CMS for expanding precision medicine into the cancer arena. Molecular profiling identifies more patients for biomarker-driven, commercially available therapies and as well as clinical trial opportunities. I support coverage for all tumor types, and for both solid tumor and liquid biopsy. For broad patient access and successful implementation, the CED registry requirements need to have a low administrative burden to entry for the patient and physician.

Thank you for your

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Ambinder, roy Title: MD
Organization: Florida Cancer Specialists
Date: 01/02/2018
Comment:
I think this testing is crucial for all my advanced cancer patients; most of these patients are incurable with current chemotherapy and the FGS allows these patients an opportunity to respond to targeted care and as well as immunotherapy. The costs saving to the CMS are well worth it, because if saves the patient often from taking chemotherapy and allows them initial better up-front opportunities to respond to either target therapy or immunotherapy that is often better tolerated and has less

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Kumar, Kapisthalam Title: MD
Organization: Florida Cancer specialists
Date: 01/02/2018
Comment:
We applaud the Agency for this key step forward in expanding precision medicine into the cancer arena. It immensely helps our goal of leveraging our proven knowledge of cancer genomics to finding new, more effective treatments for various forms of this disease.
High-quality, broad molecular profiling identifies more patients for biomarker-driven, commercially available therapies and clinical trials in an expeditious and efficient manner.That helps patient avoid chemotherapy and

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Harwin, M.D., William Title: President, Founder and Managing Partners
Organization: Florida Cancer Specialists
Date: 01/02/2018
Comment:

We applaud the Agency for this key step forward in expanding precision medicine into the cancer arena. It bolsters our collective goal of leveraging our proven knowledge of cancer genomics to finding new, more effective treatments for various forms of this disease.

High-quality, broad molecular profiling identifies more patients for biomarker-driven, commercially available therapies and clinical trials in an expeditious and efficient manner.

We are encouraged that there is a

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Nagarajan M.D., Ph.D., Rakesh Title: Chief Executive Officer (CEO)
Organization: PierianDx Inc.
Date: 12/31/2017
Comment:

Commenters: Rakesh Nagarajan, M.D., PH.D., Shalini Verma M.D., FCAP

Rakesh Nagarajan, M.D., PH.D.
Title:
Chief Executive Officer (CEO), PierianDx Inc.
Adjunct Associate Professor, Department of Pathology & Immunology, Washington University School of Medicine
Member, Molecular Oncology Committee, College of American Pathologists (CAP)
Member, Next-Generation Sequencing (NGS) Project Team, College of American Pathologists (CAP)
Member, Genomic Medicine

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Boyle, Theresa Title: Assistant Professor
Organization: Moffitt Cancer Center
Date: 12/29/2017
Comment:

Thank you for this opportunity to comment on this proposal regarding Next Generation Sequencing (NGS) for Medicare Benificiaries with Advanced Cancer.

As a thoracic molecular genetic pathologist at Moffitt Cancer Center, I interpret and sign out clinical genetic results of our in-house NGS assay and serve as a medical advisor to the Personalized Medicine group for the interpretation and personalization of results of comprehensive genetic profiling of cases sent to external

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McBrien, Judith Date: 12/29/2017
Comment:

1. Why does Coverage only apply to: (a) those who have advanced cancer and (b) those not previously NGS tested? Our cholangiocarcinoma patients need multiple testing.
2. Why does Coverage with Evidence still have restrictions above? Can those under Medicare age qualify?
3. Competition- page 10 describes 5 other FDA NGS test companies/institutions—but 2 are Foundation Medicine affiliates. The other 3 are limited in scope. Without competition, what can put the lid on costs?
4.

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Christensen, Jerilyn Title: CCF Advocacy Committee Member
Organization: Cholangiocarcinoma Foundation
Date: 12/29/2017
Comment:

As a member of the Cholangiocarcinoma Foundation Advocacy Committee and a former caregiver, I am providing the following comments in response to the proposal for NGS for Medicare beneficiaries with advance cancer:

Utilizing a More Proactive Approach – While I commend CMS and the FDA for recognizing the importance of NGS, I believe that testing and reimbursement for molecular profiling needs to be expanded to become the standard care of treatment when first diagnosed and when a

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Zhen, Chao Jie Date: 12/28/2017
Comment:
I work for a hospital laboratory specializing in next generation sequencing (NGS). The new changes to NGS testing reimbursement by CMS will be detrimental to diagnostic labs, like ours, all around the country. Everyday we offer invaluable diagnostic information to our own and outside hospital physicians and clinicians so that they have access to the most comprehensive set of genomic data to guide them in treating their cancer patients. For example, several times a month we have doctors asking

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Fuller, Tammie Date: 12/28/2017
Comment:

As part of Team SURVIVEiT, a nonprofit patient advocacy that provides hope, knowledge, and resources crucial to surviving cancer, we want to commend the FDA and CMS on their efforts to expand Medicare coverage of this potentially life-saving test to more patients. Comprehensive genomic profiling achieved through the FoundationOne CDx test, assesses all classes of genomic alterations in 324 genes known to drive cancer growth. This testing provides potentially actionable information to help

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Benhamed, Sonia Title: Laboratory Manager
Organization: University of Chicago Medicine, Molecular Pathology Lab
Date: 12/28/2017
Comment:
I work at an academic hospital lab, and our job is to use the state of the art NGS testing to offer standard-of-care for cancer patients. Our NGS assays are used for basic diagnosis and decision-support for standard approved therapies on a daily basis. I personally enjoy working closely together with physicians and pathologists to participate in personalized oncology clinical care. At the end of each work day, we as a team feel satisfied because we have probably contributed to saving many

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Cohen, MD, PhD, Daniel Title: Director of Microbiology and Molecular Diagnostics
Organization: Veteran Affairs Medical Center, Houston Texas
Date: 12/28/2017
Comment:

Dear Sir/Madam,

I provide daily care to our nations veterans in one of the largest VA's in our wonderful country.

Thank you for your work contributing to ensuring the best care for all persons with illness in our country.

Molecular testing is crucial to my daily practice and is the standard of care. Molecular testing includes many diverse analytes. In the spheres of Oncology and Infectious Diseases, these analysis methods evolve rapidly.

In cancer

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Kennedy, Brian Date: 12/28/2017
Comment:

December 28, 2017

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

RE: NCD CAG-00450N

Dear Ms. Syrek,

On behalf of the Alliance for Patient Access (AfPA), thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed National Coverage Determination for next-generation sequencing (NGS)-based in vitro

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Baccon, Jennifer Title: MD, PhD
Organization: Akron Children's Hospital
Date: 12/28/2017
Comment:

Dear CMS,

My name is Jennifer Baccon, MD, PhD, and I am the Chair of the Department of Pathology and Laboratory Medicine at Akron Children’s Hospital and Chair of Pathology at the Northeast Ohio Medical University. Thank you for the opportunity to comment on the proposed NCD. My work as a pathologist centers around providing the highest quality diagnostic care for the children in Northeast Ohio. NGS-based tests for advanced cancer that we provide in our laboratory are important to

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Conley, Barbara Title: MD
Date: 12/28/2017
Comment:

Addressing the question: Should the proposed NCD be expanded or narrowed by clinical conditions, test methodology to measure the same clinical biomarker, or clinical scenarios? If so, please provide supporting documentation, including peer-reviewed evidence, and a detailed analysis in support of your view. comment:

The CED excludes performing the same test more than once. However, it is likely that there may be a need to repeat the same test (although the test will likely be

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Dumanois, Robert Organization: Thermo Fisher Scientific
Date: 12/28/2017
Comment:

December 28, 2017

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

Re: CAG-00450N (NGS for Medicare Beneficiaries with Advanced Cancer)

Dear Ms. Jensen:

On behalf of Thermo Fisher Scientific’s Clinical Next-Generation Sequencing Division, we thank you for the opportunity to provide comments on the proposed National

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Mezzetti, Thomas Title: Pathologist and Laboratory Medical Director
Organization: Pathgroup, Associated Pathologists, Erlanger Healthcare System
Date: 12/27/2017
Comment:

Dear CMS approval board personnel:

I am a pathologist with over seventeen years’ experience, a background in academic and community practice, and a strong focus on oncology. I work with PathGroup, the largest privately-owned anatomic pathology group in the country (with a state-of-the-art molecular pathology division) and serve as a regional laboratory medical director affiliated with the Erlanger Healthcare System, one of the largest healthcare providers in the Southeast and the

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Gleason, Padric Title: North America Manager
Organization: London & Partners
Date: 12/27/2017
Comment:
In the interest of advancing personalized medicine, informed by comprehensive patient data and the latest in medical monitoring, diagnostics, and testing... I write in support of this proposed coverage. The widespread adoption of Next Generation Sequencing will help to ensure that patients are informed about their disease and treatment options, keep families aware of the risks inherent in there genetic makeup, and it will produce a body of clinical data for researchers to unlock new insights.

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Malin, Jennifer Title: Senior Medical Director, Oncology and Genetics
Organization: UnitedHealthcare
Date: 12/27/2017
Comment:

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

December 27, 2017

RE: Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

Dear Ms. Syrek-Jensen:

On behalf of UnitedHealthcare, we appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services’

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Patel, Sohil Title: Assistant Professor of Neuroradiology
Organization: University of Virginia Health System
Date: 12/27/2017
Comment:

Thanks to CMS for the opportunity to comment on the proposed NCD. I take care of cancer patients routinely in my clinical practice. In my opinion, the NCD goes beyond approving the F1CDx assay, and is too restrictive in excluding other clinically validated under CAP/CLIA auspices. Next generation sequencing is a technology, not a diagnostic test, hence it is inappropriate for CMS to broadly exclude entire categories of testing (those that use next generation sequencing) when such testing

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Ellefson, Matt Title: Founder and CEO
Organization: SURVIVEiT®
Date: 12/27/2017
Comment:

As part of Team SURVIVEiT, a nonprofit patient advocacy that provides hope, knowledge, and resources crucial to surviving cancer, we want to commend the FDA and CMS on their efforts to expand Medicare coverage of this potentially life-saving test to more patients. Comprehensive genomic profiling achieved through the FoundationOne CDx test, assesses all classes of genomic alterations in 324 genes known to drive cancer growth. This testing provides potentially actionable information to help

More

Tuthill, MD, J. Mark Title: Division Head, Pathology Informatics
Organization: Henry Ford Health System, K-6 Pathology
Date: 12/27/2017
Comment:

Dear CMS,

Thank you for the opportunity to comment on the proposed NCD changes that limit coverage to only FDA approved tests for NGS testing.

I am a pathology that has worked in developing and applying molecular diagnostics to improve patient care and outcomes in both oncology and non-oncologic diagnostic testing. As proposed, I believe the scope and impact of this change is unnecessarily large and will result in decreased testing options and increased costs for

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Woda M.D., Bruce A. Title: Vice-Chair and Professor
Organization: University of Massachusetts Medical School
Date: 12/27/2017
Comment:

December 27, 2017

Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: CAG-00450N - Proposed Decision Memo for Next Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

Dear Administrator Verma:

I am writing to comment on the national coverage decision regarding NGS analysis of tumors from patients with advanced cancer. I am Professor and Vice-Chairman of the Department of Pathology at the University

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Williams, Eli Date: 12/26/2017
Comment:
I would like to voice my strong opposition to the proposed NCD for next generation sequencing. This proposal restricts the broad application of clinical NGS technology by failing to recognize the role of NGS in infectious disease testing and constitutional genetics. Moreover, the restriction of NGS reimbursement to one assay (F1CDx)is anti-competitive and fails to recognize the oversight of lab developed NGS assays by existing CLIA/CAP regulations. I urge CMS to consider appropriately

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Bruxvoort, Kathy Date: 12/23/2017
Comment:

As part of Team SURVIVEiT, a nonprofit patient advocacy that provides hope, knowledge, and resources crucial to surviving cancer, we want to commend the FDA and CMS on their efforts to expand Medicare coverage of this potentially life-saving test to more patients. Comprehensive genomic profiling achieved through the FoundationOne CDx test, assesses all classes of genomic alterations in 324 genes known to drive cancer growth. This testing provides potentially actionable information to help

More

Peace, Stephanie Date: 12/22/2017
Comment:

part of Team SURVIVEiT, a nonprofit patient advocacy that provides hope, knowledge, and resources crucial to surviving cancer, we want to commend the FDA and CMS on their efforts to expand Medicare coverage of this potentially life-saving test to more patients. Comprehensive genomic profiling achieved through the FoundationOne CDx test, assesses all classes of genomic alterations in 324 genes known to drive cancer growth. This testing provides potentially actionable information to help

More

Goswami, Joydeep Title: President, Clinical NGS and Oncology
Organization: Thermo Fisher Scientific
Date: 12/22/2017
Comment:

December 22, 2017

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

Re: CAG-00450N: NGS for Medicare Beneficiaries with Advanced Cancer

Dear Ms. Jensen:

On behalf of Thermo Fisher Scientific’s Clinical Next-Generation Sequencing Division, we thank you for the opportunity to provide comments on the proposed

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Zhou, Yaolin Title: Dr.
Date: 12/22/2017
Comment:

I am a patient, patient advocate, and molecular pathologist within a major academic cancer center. I can also assure you that restricting coverage of NGS-based testing to FDA-approved tests will be major hindrance to the care of our local cancer patients.

Molecular pathology laboratories work extremely hard to collaborate with oncology and surgery colleagues to better understand the needs of our local patients. While the Foundation Tests are helpful for patients who have reached a

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Mackinnon, Alexander Title: Associate Professor
Organization: Medical College of Wisconsin
Date: 12/22/2017
Comment:

Administrator Seema Verma
Centers for Medicare and Medicaid Services

20 December 2017

Re: Centers for Medicare & Medicaid Services (CMS) Proposed National Coverage Determination for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

Dear Administrator Verma,

Thank you for the opportunity to provide comment on the Centers for Medicare and Medicaid Services Proposed National Coverage Determination for Next Generation

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Schorr, Andrew Title: Founder and CEO
Organization: Patient Power LLC
Date: 12/22/2017
Comment:

[PHI Redacted] online journalist who reaches more than 150,000 US cancer patients each month via patientpower.info, The Cancer Connection on Facebook, and many websites of partner patient organizations and medical centers, I heartily endorse this proposed change in policy. Further, as co-founder of the new "Recision Medicine for Me" consortium of patient organizations, I see it as imperative that patients with advanced cancer - in an age of targeted and immunotherapies -

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Schorr, Esther Title: Co-Founder and CMO/COO
Organization: Patient Power LLC
Date: 12/22/2017
Comment:

As a supporter of Team SURVIVEiT, a nonprofit patient advocacy that provides hope, knowledge, and resources crucial to surviving cancer, we want to commend the FDA and CMS on their efforts to expand Medicare coverage of this potentially life-saving test to more patients. Comprehensive genomic profiling achieved through the Foundation One CDx test, assesses all classes of genomic alterations in 324 genes known to drive cancer growth. This testing provides potentially actionable information

More

Sykes, Daniel Date: 12/22/2017
Comment:
This is a very sad proposal for laboratories and laboratory professionals around the country that are trying to do good work treating patients. NGS is the most important tool in genetics, used the world over for every day patient testing. This proposal shuts out every lab in the country except for one from working in this field by imposing the highest possible barriers. Time to buy some Foundation Medicine stock.
Wick, Mark Title: M.D.
Organization: University of Virginia Health System
Date: 12/22/2017
Comment:

I write to the agency concerning a proposed ruling that CMS would reimburse only one form of molecular testing for malignant neoplasms; namely, the F1CDx by Foundation One. That would be a poor decision for the following reasons:

-The NCD in fact goes beyond approving the F1CDx assay, and is too restrictive in excluding other clinically validated assays that are covered under the auspices of the CAP & CLIA;
-Next generation sequencing is a technology, not a diagnostic test, and

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Coughlin, Robert K. Title: President & CEO
Organization: Massachusetts Biotechnology Council
Date: 12/22/2017
Comment:

December 22, 2017

Ms. Seema Verma
Administrator
Centers for Medicare and Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Re: Support for Proposed National Coverage Determination (NCD) - CAG-00450N

Dear Administrator Verma:

I am writing in strong support of the Centers for Medicare and Medicaid Services’ (CMS) proposed decision to reimburse Foundation Medicine's comprehensive cancer diagnostic test,

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Zehentner, Barara Date: 12/21/2017
Comment:

I would like to thank CMS for the opportunity to comment on the proposed NCD.
I work as a molecular biologist in a pathology office specializing in hematopathology serving community hospitals and pathology offices nationwide. NGS-based testing has become crucial for correctly diagnostic hematopoietic malignancies and most importantly to accurately stratify prognosis as well as select appropriate treatment regimes. If the proposed NCD were finalized as written, it will negatively impact

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Barbeau, James Title: M.D.
Organization: Brown University/Lifespan AMC
Date: 12/21/2017
Comment:
Logically, the NCD should really address Foundation Medicine's test and nothing else. As it stands, there is very little baby and a whole lot of bath water in the proposed NCD. There is no reason to go beyond providing an NCD to Foundation Medicine, but instead, CMS wants to set up a registry and restrict coverage to FDA-approved companion diagnostic NGS tests. That puts a strangle-hold on the sort of testing that is available to oncologists as they practice medicine and exercise their

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Zajchowski, Deborah Title: Scientific Director
Organization: The Clearity Foundation
Date: 12/21/2017
Comment:

December 21, 2017

I am writing today to offer comments and support regarding the Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N).

The Clearity Foundation is a leading patient advocacy organization whose mission is to help ovarian cancer patients and their physicians make better-informed treatment decisions based on the molecular profiling of their tumors. Such molecular information is obtained through

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Schiff, David Organization: University of Virginia
Date: 12/21/2017
Comment:
I am writing about NCD for NGS in Advanced Cancer.
Many academic medical centers with CLIA-approved laboratories, including ours, have clinically validated actionable gene panels similar to Foundation One. There is no earthly reason to favor a single company.
Burack, Richard Title: Professor of Pathology
Organization: University of Rochester
Date: 12/21/2017
Comment:

I am the director of clinical operations for the department of pathology and laboratory medicine at the University of Rochester in Rochester NY. My particular clinical and scientific focus is the diagnosis and care of patients with lymphomas and leukemia. NGS-based testing has rapidly become a key-diagnostic tool allowing us diagnostic specificity and much enhanced care. let me tell you 2 stories that illustrate this-and illustrate that we just dont have the data yet to justify locking

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Lopes, Maria B Title: Professor of Pathology
Organization: University of Virginia
Date: 12/21/2017
Comment:
CMS coverage policy for Medicare beneficiaries should not exclude entire categories of testing, i.e., those that use NGS technology, when such testing is performed in CLIA accredited laboratories and adheres to evidence-based guidelines developed by leading scientists and subject matter experts and endorsed by medicine’s preeminent professional societies, including AMP, CAP, ASCO, ASH, WHO, and NCCN. Our patients need these tests for better treatment decision.
Tung, Kenneth Title: MD
Organization: University of Virginia
Date: 12/21/2017
Comment:

The NCD goes beyond approving the F1CDx assay, and is too restrictive in excluding other clinically validated under CAP/CLIA auspices.

Next generation sequencing is a technology, not a diagnostic test, hence it is inappropriate for CMS to broadly exclude entire categories of testing (those that use next generation sequencing) when such testing is being performed in CLIA accredited laboratories.

Such broad exclusion will stifle innovation and give unfair advantage to a

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Braun, Jonathan Title: Professor and Chair
Organization: UCLA David Geffen School of Medicine
Date: 12/21/2017
Comment:

I am Jonathan Braun, professor and chair of pathology and laboratory medicine at the David Geffen School of Medicine of UCLA in Los Angeles. I appreciate the chance to share my thoughts on the proposed NCD regarding NGS.

I direct pathology and lab medicine services of our academic medical center and its regional clinical program, that serves more than 2.5 million patients annually. UCLA pathology and lab medicine provides more than 6 million laboratory tests and renders over

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Afkhami, Michelle Title: Medical Director, Clinical Molecular Diagnostics
Organization: City of Hope Cancer Center
Date: 12/21/2017
Comment:

Regarding the proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

As a medical director of an high volume clinical molecular diagnostic laboratory (CMDL) at City of Hope Cancer Center (COH), I find this proposed coverage determination very damaging for patients and patient care providers which will introduce major limitation on availability of testing for patient and on different patient tissue type.

In

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Moskaluk, Christopher Title: Professor
Organization: University of Virginia
Date: 12/21/2017
Comment:
I wish to voice my strong opposition to the NCD for next generation sequencing panels for oncology care, in stipulating F1CDx as essentially the only assay available for reimbursment. The NCD is entirely too restrictive, anti-competitive and ignores the robust oversight that CAP/CLIA play in overseeing laboratory-developed tests using next generation sequencing (NGS). NGS is a technology that its broadly used for many types of diagnostic situations including constitutional genetics and

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Telatar, Milhan Title: Director, Clinical Molecular Diagnostic Laboratory
Organization: City of Hope National Medical Center
Date: 12/21/2017
Comment:

Regarding the proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

This proposed coverage determination will have negative impact as we are routinely doing standard of care practice in our CLIA and CAP certified NGS laboratory at City of Hope National Cancer Center by performing multiple laboratory developed NGS assays for solid tumor and hematologic malignancy as well as germline and cancer predisposition

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Hu, Yan Date: 12/21/2017
Comment:

-NGS oncology testing at academic centers and other labs is standard of care, for making basic diagnoses and to help manage patients on standard-of-care approved medications. We are doing basic clinical service in our labs.
**Important**
-Patients depend on these tests being readily available in order to get diagnosed and treated.
-FDA approval is extremely difficult, expensive and time-consuming to get, and there is no available pathway.
-The coverage determination will

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Pettersson, Jonas Title: Laboratory Supervisor
Organization: USC Clinical Laboratories
Date: 12/21/2017
Comment:
NGS oncology testing is standard of care used to accurately diagnose disease and deliver individualized care. It helps physicians manage patients on standard-of-care approved medications. We are providing basic clinical service that patients depend on in order to be diagnosed and treated.
Cancer care is changing rapidly and laboratory developed tests ( LDTs) provide a critical mechanism by which patients can be tested for the latest biomarkers. Novel testing must be brought to the clinic

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Louis, David Title: Chief of Pathology and Castleman Professor
Organization: Massachusetts General Hospital and Harvard Medical School
Date: 12/21/2017
Comment:
I am writing as the chairman of the Pathology department at the Massachusetts General Hospital and the Benjamin Castleman Professor of Pathology at Harvard Medical School. My department has been on the cutting edge of using next-generation sequencing (NGS) assays for the diagnosis and management of patients with cancers for many years. Using these approaches, we have provided countless Medicare patients with critical diagnostic information. In this regard, we are very concerned with the

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Ward, Pamela Title: Associate Professor, Clinical Pathology
Organization: USC Keck Medicine
Date: 12/21/2017
Comment:

Limiting any test to only those that are FDA approved denies patients and their clinicians access to better testing options. The time taken to bring a test to the FDA is substantial and new findings, adding additional mutational targets into existing panels, will delay patient access to targeted therapies and result in poor clinical outcomes. One example is the recent extended RAS testing guidelines to include KRAS and NRAS codons 12, 13, 117 and 146. As of June 2017, the FDA approved

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Ritterhouse, Lauren Title: Dr.
Organization: University of Chicago Medicine
Date: 12/21/2017
Comment:

To Whom It May Concern:

In regards to the proposed decision for NGS for medicare beneficiaries with advanced cancer, I want to declare my strong protest and deep concerns. I am one of the medical co-directors of the clinical genomics laboratory at the University of Chicago Medicine. In our laboratory, we perform greater than 1500 NGS-based cancer assays every year as laboratory-developed tests. This testing is not done for research purposes or simply to direct patients to clinical

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Shirts, Brian Title: Assistant Professor of Laboartory Medicine
Organization: University of Washington
Date: 12/21/2017
Comment:

I welcome the CMS decision to cover diagnostic NGS tests of tumor tissue in patients with recurrent, metastatic, and advanced cancer who seek further cancer treatment. This testing and the targeted treatment it enables has been show to prolong the lives of many cancer patients.

I am concerned about the decision to only cover FDA-approved companion diagnostics. The CMS oversees laboratory developed diagnostic services governed by CLIA legislation, and evidence demonstrates that the

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Kolhe, Ravindra Title: Associate Professor
Organization: Augusta University
Date: 12/21/2017
Comment:

Hi,
Thanks for this opportunity to comment on the proposed NCD.

I am licensed physician in the state of Georgia and I practice laboratory medicine (Pathology) with focus on molecular pathology.

  • In our CLIA laboratories we perform NGS based testing for diagnosis, prognosis and therapy selection for many of these patients who come from communities which are labeled as Health Professional Shortage Areas (HPSAs) and Medically Underserved Areas or Populations

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  • Hutchinson, Lloyd Organization: Univeristy of Massachusetts, Umass Memorial Health Care
    Date: 12/21/2017
    Comment:

    December 19th, 2017

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

    RE: CAG-00450N - Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.

    Dear Director Jensen,

    Thank you for providing this opportunity to comment on a national coverage decision regarding NGS analysis of tumors from patients

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    Neff, Jadee Title: Assistant Professor of Pathology
    Organization: Duke University Medical Center
    Date: 12/21/2017
    Comment:

    To whom it may concern:

    Thank you for the opportunity to comment. I am a molecular genetic pathologist (a full time clinical doctor) who regularly analyzes patient tumors as part of their routine clinical care. My patient base includes both Medicare and non-Medicare beneficiaries. I believe that the restriction of NGS testing to FDA approved tests only would severely harm patients as it will limit timely access to crucial cancer testing.

    Most tumors have common

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    Mardis, Elaine Title: Co-executive Director
    Organization: Institute for Genomic Medicine at Nationwide Children's Hospital
    Date: 12/21/2017
    Comment:
    The requirements for FDA approval of companion diagnostic tests in this policy are quite concerning. FDA has yet to approve an NGS-based companion diagnostic, therefore a pathway has not yet been defined by them. Further, having worked with the FDA trying to identify needed standard for establishing the validity and reproducibility of NGS-based tests in the past, there is clearly no consensus they have as yet arrived at for defining these standards and how they are to be included into the

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    Carter, Alexis Title: Physician Informaticist and Pathologist
    Organization: Children's Healthcare of Atlanta
    Date: 12/21/2017
    Comment:

    Dear CMS and Others to Whom It May Concern,

    I am writing to make several objections on behalf of patients to the Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N). I am a physician who specializes in pathology and specifically in molecular genetic pathology with a focus in testing of cancer patients for clinical care.

    NGS testing is absolutely critical for many cancers in both adults and children at the time of

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    Kaul, Karen Title: MD PhD, Chair of Pathology and Lab Medicine
    Organization: NorthShore University HealthSystem
    Date: 12/21/2017
    Comment:

    Molecular characterization of tumors is critical to making a diagnosis for many tumors, as well as for the determination of appropriate therapy. Over recent years, this testing has evolved from single gene studies to panels done by next-generation sequencing (NGS). Hospitals across the country have implemented in-house NGS so that they can provide needed information to patients and physicians caring for them. (Our community-based hospital has performed this testing in-house for several

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    Puranik, Rutika Date: 12/21/2017
    Comment:
    I am a full time employee at an academic hospital lab working on NGS cancer panel. Our group focuses on patient care and I enjoy working closely with pathologists and physicians. NGS data for cancer patients is a stepping stone platform for developing new cancer drugs and treatment plans. NGS helps in the precision medicine aim for treating patients in an innovative manner. This is a working healthcare clinical facility that I work for and its not research. NGS in cancer treatment, opens up

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    Kratzer, Tauna Date: 12/21/2017
    Comment:
    I am not an academic so have no quantifiable information to share in regards to the viability of this type of treatment. That being said, I have seen far too many lives destroyed by this disease to agree with an FDA decision that would do away with a treatment that might be able to help those suffering from it. I ask that they take a more critical look at this benefit to determine if it can continue.
    Sundin, Tabetha Title: Scientific Director
    Organization: Sentara Healthcare
    Date: 12/21/2017
    Comment:
    We perform NGS testing for our cancer patients. Biomarkers are being used to get the right patients on the right medicine. The cost of the test is far cheaper than the cost of the pharmaceutical agent. We are not performing research in our laboratory. Our laboratory is situated in a hospital. The results of our tests directly alter treatment for the patients. We would love to use only FDA-approved tests in the laboratory. Often there is not one available or the ones available have

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    Niu, Nifang Organization: University of Chicago Medicine
    Date: 12/21/2017
    Comment:
    To treat cancer patients has long been a big challenge, especially for the advanced cancer. Clinical NGS testing has been proved very helpful for personalized clinical oncology care. Genetic biomarkers detected by clinical NGS assay can help selecting right treatment for right patient, minimizing side effects, and also reduce medical cost. Currently I am working full time in a clinical NGS Lab at an academic hospital. We conduct standard-of-care NGS testing for cancer patients to help basic

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    Farooqi, Midhat Date: 12/20/2017
    Comment:
    NGS oncology testing at academic centers and other labs is standard of care, for making basic diagnoses and to help manage patients on standard-of-care approved medications. We are doing basic clinical service in our labs. This testing is NOT for clinical trials. It is especially important for patients with advanced cancer who have failed standard chemotherapy or their tumors have evolved to gain resistance to such therapy. Removing Medicare beneficiaries from this patient pool further skews

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    Webber, Daniel Title: Clinical Pathology Resident
    Organization: Barnes Jewish Hospital, Washington University School of Medicine
    Date: 12/20/2017
    Comment:
    I am a clinical pathology resident at Barnes Jewish Hospital. I am writing because of my deep concern regarding oversight and reimbursement for next generation testing (NGS) Medicare Beneficiaries with Advanced Cancer. Recent advances in cancer diagnosis and treatment have been based upon insights derived from NGS sequencing. Cancer genetics have been shown to aid in diagnosis of cancer and inform treatment decisions. As a result, NGS testing has become standard of care for diagnosis,

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    Spencer, David Title: Assistant Professor, Medical Director
    Organization: McDonnell Genome Institute, Washington University in St. Louis
    Date: 12/20/2017
    Comment:

    I am commenting on the proposal to require FDA approval for Medicare coverage of some NGS-based clinical testing.

    This would virtually eliminate this type of cancer testing at nearly all laboratories in the country, which would stifle competition and innovation. NGS testing of cancer patients is standard of care, and occurs at academic centers and other labs as part of the routine management of cancer patients. These patients, and their physicians, depend on this testing to obtain

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    Brown, Noah Title: Medical Director
    Organization: University of Michigan Molecular Diagnostics Laboratory
    Date: 12/20/2017
    Comment:

    Thank you for the opportunity to comment on this important issue. As a molecular pathologist and the director of the molecular diagnostics laboratory at the University of Michigan, I am keenly aware of the impact that this NCA will have patient care. I am happy that CMS and insurance carriers are recognizing the important impact of NGS testing in advanced stage cancer patients. However, I believe the policy as currently written is likely to be detrimental to patient care.

    In

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    Markman, Maurie Title: M.D., M.S., FACP, FASCO
    Organization: Cancer Treatment Centers of America
    Date: 12/20/2017
    Comment:

    Re: Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)

    Dear Commissioner Gottlieb and Administrator Verma:

    As an oncologist and leader of the clinical division of an oncology provider, I am writing to commend the recent decision by the Food and Drug Administration (FDA) to approve Foundation Medicine's comprehensive cancer diagnostic test, FoundationOne CDx (F1CDx), and the proposed decision by the

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    Curtis, Shannon Title: Assistant Director, Federal Affairs
    Organization: American Medical Association
    Date: 12/20/2017
    Comment:

    On behalf of the physician and medical student members of the American Medical Association (AMA), we appreciate the opportunity to provide comments on the Centers for Medicare & Medicaid Services (CMS) Proposed National Coverage Determination (NCD) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer. We support immediate national coverage for the FoundationOne CDx (F1CDx) test. In addition, we strongly urge CMS to convene a public meeting to more

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    Fenton Ambrose, Laurie Title: President & CEO
    Organization: Lung Cancer Alliance
    Date: 12/20/2017
    Comment:

    Lung Cancer Alliance applauds CMS for covering next generation sequencing (NGS) tests that can help patients and their physicians identify the best treatment options based on the molecular makeup of their cancer. We have direct experience with these tests through our LungMATCH program that provides testing to help identify a patient’s personalized treatment options. Based on our experience, we believe that appropriate, high-quality testing is helping patients with lung cancer survive

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    Scott, E. Michael D. Title: Co-Founder and President
    Organization: Prostate Cancer International
    Date: 12/20/2017
    Comment:

    Gentlepersons:

    Prostate Cancer International is highly supportive of the Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N) with specific emphasis on the importance of full coverage of those NGS tests that have met FDA criteria for approval as companion diagnostics associated with the approval of specific drugs for the treatment of specific conditions in carefully defined and selected groups of patients carrying

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    Schwartz, Gary Title: Chief, Divisoin of Hemaology and Oncology
    Organization: Columbia University Irving Medical Center
    Date: 12/20/2017
    Comment:

    December 19th, 2017

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

    Re: NCD CAG-00450N

    Dear Ms. Syrek Jensen,

    I am writing in my role as the Chief of the Division of Hematology and Oncology in the Department of Medicine at Columbia University Irving Medical Center (CUIMC). The oncologists at CUIMC would like to thank CMS for the opportunity

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    Lindeman, Neal Title: Associate Professor, Pathology
    Organization: Brigham&Women's Hospital, Dana-Farber Cancer Institute, Harvard
    Date: 12/20/2017
    Comment:

    Thanks, but...

    The decision to cover genomic sequencing panels for a subset of advanced cancer patients is a welcome step towards realizing precision oncology and improving care and quality of life for American's cancer patients.

    The decision to cover only FDA-approved assays, however, is a misguided attempt to safeguard patient safety from the threat posed by the cooption of the CLIA/LDT process by commercial entities who have exploited the enforcement discretion for

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    Gibson, Ben Title: VP for Government Affairs
    Organization: University of Chicago Medical Center
    Date: 12/20/2017
    Comment:

    The following comments are respectfully submitted on behalf of the University of Chicago Medical Center in response to the “Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)”:

    As we understand the proposal, Medicare would only pay for genomic sequencing tests that are FDA approved.  It is important to note that these sequencing tests are performed daily at well over one hundred different accredited

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    Wooten, MHA, Terry Title: Vice President of Operations - Support Services &
    Organization: Mission Hospital
    Date: 12/20/2017
    Comment:

    December 20, 2017

    The Honorable Scott Gottlieb, MD
    Commissioner
    Food and Drug Administration
    10903 New Hampshire Avenue, Room 2217
    Silver Spring, MD 20993

    Ms. Seema Verma
    Administrator
    Centers for Medicare and Medicaid Services
    200 Independence Avenue, SW
    Washington, DC 20201

    Dear Commissioner Gottlieb and Administrator Verma:

    I am writing to commend the recent decision by the Food and Drug Administration (FDA) to

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    Peters, Susan Organization: JMJ Caseworks
    Date: 12/19/2017
    Comment:

    This provision currently only covers the cost of this test one time in patient’s lifetime. This test is only valid for the day in time that the biopsy was taken. It is no longer valid two years later when a patient has a recurrence.
    Patients should be covered for the genomic sequencing test for each recurrence. This is crucial for long-term survival.

    Companion drug matching should not be only for the organ site the original biopsy was taken, but instead should be approved

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    Brewster, Joy Organization: SURVIVEiT
    Date: 12/19/2017
    Comment:
    This provision currently only covers the cost of this test one time in patient’s lifetime. This test is only valid for the day in time that the biopsy was taken. It is no longer valid two years later when a patient has a recurrence.
    Patients should be covered for the genomic sequencing test for each recurrence. This is crucial for long-term survival.
    Companion drug matching should not be only for the organ site the original biopsy was taken, but instead should be approved for the

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    Billings, Jennifer Title: PharmD
    Organization: Humana
    Date: 12/19/2017
    Comment:
    We are proposing that the NCD contain billing guidance much like the other laboratory NCDs through attachment “Billing and Coding Information Medicare National Coverage Determination (NCD) Coding Policy Manual and Change Report (ICD-10-CM), Clinical Diagnostic Laboratory Services.” We would like to recommend the following CPT codes be used to bill for the NGS services covered in the Proposed Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

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    Davis, Richard Title: Founder
    Organization: Answer Cancer Foundation
    Date: 12/19/2017
    Comment:

    Answer Cancer Foundation is an organization providing patient advocacy, navigation & support. We congratulates CMS on recognizing the value in Next Generation Sequencing and encouraging the use of this tool for identifying treatment. AnCan believes there is room for some improvement and make the following suggestions in the spirit of improving your proposal.

    AnCan notes that easy access is restricted to just the five named cancers - non-small cell lung, colorectal, melanoma, breast

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    Arensdorf, Matthew Date: 12/19/2017
    Comment:

    This provision currently only covers the cost of this test one time in patient’s lifetime. This test is only valid for the day in time that the biopsy was taken. It is no longer valid two years later when a patient has a recurrence. Patients should be covered for the genomic sequencing test for each recurrence. This is crucial for long-term survival.

    Companion drug matching should not be only for the organ site the original biopsy was taken, but instead should be approved for the

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    Stachler, Matthew Title: Instructor of Pathology
    Organization: Brigham and Women's Hospital
    Date: 12/19/2017
    Comment:

    Hello, I am a molecular pathologist who works at Brigham and Women's Hospital, an academic and teaching hospital, in Boston. I wanted to stress the importance of covering NGS test for advanced cancer patients. I have seen firsthand how using a broader technique has allowed the identification of more effective treatments in patients with advanced cancer. I think the biggest strength is the ability to find those known and targetable alterations in cancers where that particular alteration

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    Roth, MD, PhD, Kevin A. Title: Chair, Department of Pathology and Cell Biology
    Organization: Columbia University Medical Center
    Date: 12/19/2017
    Comment:

    December 18th, 2017

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

    Re: NCD CAG-00450N

    Dear Ms. Syrek,

    We write as representatives of the Department of Pathology and Cell Biology at Columbia University Irving Medical Center and New York Presbyterian Hospital-Columbia. We would like to thank CMS for the invitation to comment on National Coverage

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    Ashton, Stewart Date: 12/18/2017
    Comment:

    This provision currently only covers the cost of this test one time in patient’s lifetime. This test is only valid for the day in time that the biopsy was taken. It is no longer valid two years later when a patient has a recurrence.
    Patients should be covered for the genomic sequencing test for each recurrence. This is crucial for long-term survival.

    Companion drug matching should not be only for the organ site the original biopsy was taken, but instead should be approved for

    More

    ASHTON, PAULA Date: 12/18/2017
    Comment:

    [PHI Redacted] has stage 4 lung cancer & testing any time she has progression of the cancer is crucial. She would not be alive today if not for this testing.This provision currently only covers the cost of this test one time in patient’s lifetime. This test is only valid for the day in time that the biopsy was taken. It is no longer valid two years later when a patient has a recurrence. Patients should be covered for the genomic sequencing test for each recurrence. This is

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    Arensdorf, Jennifer Date: 12/18/2017
    Comment:

    This provision currently only covers the cost of this test one time in patient’s lifetime. This test is only valid for the day in time that the biopsy was taken. It is no longer valid two years later when a patient has a recurrence.
    Patients should be covered for the genomic sequencing test for each recurrence. This is crucial for long-term survival.

    Companion drug matching should not be only for the organ site the original biopsy was taken, but instead should be approved

    More

    Segal, Jaymes Date: 12/18/2017
    Comment:
    I like the fact that these will be covered, but I expect most labs in the country will go out of business because of the monopoly produced.
    Dudek, Arkadiusz Title: MD,PhD
    Organization: A Breath of Hope Lung Foundation and Health Partners.
    Date: 12/18/2017
    Comment:
    Next generation sequencing became standard of care practice in my oncology clinic. Especially, for patients with diagnosis of lung cancer, where new actionable mutations are recognized, use of NGS is critical to design optimal therapy. Therefore Medicare coverage and pay for validated next generation sequencing oncology panels, will allow Medicare patients to fully benefit from recent breakthroughs in lung cancer therapy.
    Weck, Karen Title: Professor of Pathology and Laboratory Medicine
    Organization: University of North Carolina in Chapel Hill
    Date: 12/18/2017
    Comment:
    As a practicing molecular pathologist, I do not agree with the requirements that 1) the NGS test should be FDA cleared 2) the laboratory must be registered in the NIH genetic testing registry or 3) the patient and laboratory must be enrolled in a prospective registry. All of these requirements will hinder patient care.
    Cohen, Roberta Title: Ms.
    Date: 12/18/2017
    Comment:

    This provision currently only covers the cost of this test one time in patient’s lifetime. This test is only valid for the day in time that the biopsy was taken. It is no longer valid two years later when a patient has a recurrence.
    Patients should be covered for the genomic sequencing test for each recurrence. This is crucial for long-term survival.

    Companion drug matching should not be only for the organ site the original biopsy was taken, but instead should be approved for

    More

    Ding, Yi Organization: University of Rochester Medical Center
    Date: 12/18/2017
    Comment:
    I am a molecular pathologist and associate director of the molecular diagnostic laboratory at University of Rochester Medical center (Rochester, NY). Our laboratory will be affected by the recent parallel approval announced by FDA and CMS impacting Next Generation Sequencing (NGS) of solid tumors because of the NCD as it stands risks effectively eliminating an entire segment of the testing community, namely academic medical centers providing NGS testing for solid tumors to our local patient

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    Karrs, Jeremiah Title: MGP fellow
    Organization: VCU Health System Molecular Diagnostics
    Date: 12/18/2017
    Comment:
    I worry that due to the lack of FDA approved next-generation sequencing assays compared to the number of currently implemented CAP overseen lab developed next-generation sequencing assays, which vary in both their specific utility and also how they are implemented based on the patient's needs in community hospital settings, that this national coverage determination could restrict access to appropriate testing for patients.
    Marshall, Denise Date: 12/18/2017
    Comment:

    This provision currently only covers the cost of this test one time in patient’s lifetime. This test is only valid for the day in time that the biopsy was taken. It is no longer valid two years later when a patient has a recurrence.
    Patients should be covered for the genomic sequencing test for each recurrence. This is crucial for long-term survival.

    Companion drug matching should not be only for the organ site the original biopsy was taken, but instead should be approved for

    More

    Buonanno, Lysa Date: 12/18/2017
    Comment:

    I believe genomic testing should be approved by CMS. There are so many advancements in cancer treatments [PHI Redacted]

    This provision currently only covers the cost of this test one time in patient’s lifetime. This test is only valid for the day in time that the biopsy was taken. It is no longer valid two years later when a patient has a recurrence. [PHI Redacted]
    Patients should be covered for the genomic sequencing test for each recurrence.

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    Hayhurst, Tom Title: Consultant
    Organization: Horizon Performance Group
    Date: 12/18/2017
    Comment:

    To whom it may concern:

    I have attended the JP Morgan Healthcare Investment conference in early January in San Francisco for the past 10 years. Thousands of presentations and talks take place soliciting VC money for innovative ideas in healthcare. Solid tumor Dx is always a hot topic along with the associated or appropriate Rx. With the constriction of financial reimbursement to that of only tests cleared or approved as IVD through the FDA we can be assured the financial inflow

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    Liu, Cong Title: Molecular Diagnostics PhD Advisor
    Organization: Spectrum Health Molecular Diagnostic lab
    Date: 12/18/2017
    Comment:

    To whom it may concern:

    My name is Cong Liu. I am the Molecular Diagnostics PhD Advisor at Spectrum Health Molecular Diagnostic lab. First, I want to thank CMS for the opportunity to comment on the proposed NCD. Our lab severs patients in west Michigan area. The NGS-based molecular oncology testing provided in our laboratory allows prompt diagnosis and treatment selection for Medicare beneficiaries and their health care providers in our community. My concerns with the proposed NCD

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    Segal, Jennifer Date: 12/17/2017
    Comment:
    This is going to exclude almost everyone single lab in the country that does cancer diagnostics from being paid. The damage to our national cancer testing infrastructure will be unimaginable. For Foundation Medicine (who paid for this proposal) it would be great. For everyone else it's an absolute nightmare. Thousands of wonderful labs will close their doors and thousands of hard working professionals will be out of work. Cancer patients will have only one lab to go to which can not

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    Davidson, John Date: 12/17/2017
    Comment:
    Seems like this will create a horrible monopoly.
    Insider, Industry Date: 12/17/2017
    Comment:
    If I understand this correctly, Roche owns a good piece of Foundation Med, and if this becomes monopoly under the excuse of FDA guidance & patient safety, Roche would have once more implemented their SOP of taking over fragmented markets by implementing regulatory & lobbying strategy. Prices will go up & Medicare will have less money to support other services. Opposed to contrary belief, these are not complicated tests. There needs to be regulation to make sure tests perform as intended, but

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    Valyan, Selisa Title: MSN, FNP Student
    Organization: Herzing University
    Date: 12/16/2017
    Comment:

    As a soon to be Advanced Practice Nurse, I find it extremely important to be able to care for my patients in a manner that is conducive to not only promoting positive patient outcomes but doing so in a manner that is affordable. Having a [PHI Redacted] recently diagnosed with breast cancer, I have experienced first-hand not only the devastation of the disease itself, but also the astronomical costs that it entails. All too often, patients are not only dealing with the upset

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    Julian, Jeff Date: 12/15/2017
    Comment:

    [PHI Redacted] I strongly believe that every patient needs to have access to this testing. Not only is it the best information to have when deciding treatment options, it also gives the best things of all to patients and that is hope. It gives you hope that with this additional information, even more people can survive. [PHI Redacted]

    [PHI Redacted] I can tell you that I am a big believer in the need of hope for patients and this

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    Mnayer, Laila Title: Director of Molecular Pathology
    Organization: Hartford Healthcare
    Date: 12/12/2017
    Comment:
    This decision will exclude more than 99% of Molecular Labs currently offering NGS to their communities nationwide. The decision will also negatively impact the field by restricting support to a single vendor and will therefore monopolize this very much needed service at a time where new targeted therapies are constantly emerging. This is also expected to restrict patient's access to molecular testing and may therefore negatively impact patient's care. Needless to say that supporting such

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    Earle, Jonathan Date: 12/12/2017
    Comment:
    Those conditions seem inappropriately restrictive. Additionally, they appear to be contrived to support a single vendor's operations. Whether intentional or not, this may effectively create conditions conducive to a monopoly in this diagnostic space. Monopolies are fiscally dangerous for society, and actions which support their emergence are irresponsible.
    I also believe that a coverage decision in this format will have a deleterious effect on countless molecular diagnostic labs across

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    Strum, Stephen Title: MD, medical oncologist
    Organization: Private Practice Medical Oncology for 44 years
    Date: 12/10/2017
    Comment:
    I have used all the gene expression profiling (GEP) tests since the early years including Target Now (name now Caris Life Sciences), FoundationOne, Tempus, Guardant360, Personal Genome Diagnostics (PGDx) & others. FoundationOne is tissue based & many millions of patients & physicians are using GEP to help personalize medicine in cancer patients now suffering recurrence. Some recurrences are 5-10 and even 20 years later after the tissue diagnosis has been made. I would challenge some of the

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    Weiss, Glen Title: Medical oncologist
    Date: 12/10/2017
    Comment:

    This decision is terrible! Remember bone marrow transplantation for breast cancer? Until randomized clinical trial data disproved the practice, millions of dollars were spent and many women died from toxic side effects before the practice was abandoned. W

    Where is the data for F1CDx for all advanced cancers showing an overall survival benefit? For selected cancers using proven biomarkers linked to approved drugsNGS testing makes sense. The other dozens/hundreds of biomarkers are

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    Malter, James Title: Professor and Chair, Dept of Pathology
    Organization: UT SOuthwestern Medical Center, Dallas TX 75390
    Date: 12/08/2017
    Comment:
    While it is terrific that CMS will reimburse for this expensive and important assay, the limitation to FDA approved test sites will unfairly support Foundation Medicine and MSK while discriminating against equally accurate, reproducible and precise lab developed and validated NGS testing done by CLIA labs in many academic medical centers. Failure to provide reimbursement will cripple those academic labs, create a duopoly of MSK and Foundation and effective force clinicians and insitutions to

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    Schmidt, Ryan Title: Molecular Genetic Pathology Fellow
    Organization: Brigham & Women's Hopsital
    Date: 12/05/2017
    Comment:

    This coverage analysis completely ignores Laboratory Developed Tests (LDTs). The task of CMS in this analysis is to determine the clinical utility of NGS tests for advanced cancer. LDTs have established analytical validity through their distinct regulatory pathway. Evidence of the clinical validity and utility of measuring these analytes is present in the medical literature and within the IVD submissions.

    LDTs for other indications are frequently reimbursed by CMS. It is unclear

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    Eifert, Cheryl Date: 12/04/2017
    Comment:
    This policy makes no sense. Patients with stage IV cancer have likely run out of standard-of-care options. Genetic testing using mid to large sized-panels nearly always identifies a putative driver gene or a biomarker that predicts response to immune therapies. Importantly, patients with known cancer-promoting gene mutations can then be matched with a clinical trial that is evaluating an investigation therapy that is specific to the patients genetic mutation(S). This policy will deny desperate

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    Segal, Jeremy Title: Director, Genomic and Molecular Pathology
    Organization: University of Chicago
    Date: 12/02/2017
    Comment:
    What on earth are you thinking? 99% of all clinical diagnostic laboratories in the country doing NGS oncology are not FDA approved. Paying only FDA approved labs will destroy almost the entire academic laboratory molecular diagnostics community! It will also kill most of the commercial laboratories. You will be making the FDA the ultimate king-makers and monopolists. Of all of the awful decisions I've seen our government make, I've spent the last four years of my life building a vibrant

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    Siegel, Maureen Date: 12/01/2017
    Comment:
    I strongly support coverage for NGS for Medicare beneficiaries with advanced cancer. This is crucial to people with rare cancers in which little genomic data has been developed. NGS can reveal a druggable target. The information gleaned from this genomic data may end up helping many more people. Taxpayers save money in the long run when we find more effective treatments.
    Williams, Pamela Date: 12/01/2017
    Comment:
    I think this Next Generation Sequencing could be very beneficial to patients and providers in the treatment of stage IV cancers. Anything to improve on the outcome of treating patients with cancer is great. As [PHI Redacted] is currently undergoing treatment for Stage IV Colon Cancer that has spread to her liver.