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

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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: