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Position Statements & Comment Letters


June 2019

COA Comments on the ICER Value Assessment Framework

Institute for Clinical and Economic Review Two Liberty Square Ninth Floor Boston, MA 02109 On behalf of the Board of Directors of the Community Oncology Alliance (COA), I would like to thank you for inviting the Community Oncology Alliance (COA) to provide suggestions for the 2020 Patient Guide of the ICER Value Assessment Framework. COA welcomes the opportunity

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May 2019

COA Letter to CMMI Regarding Challenges That Need to Be Addressed in the OCM and Future Payment Reform Models

Mr. Adam Boehler Director Center for Medicare & Medicaid Innovation Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 Dear Adam: On behalf of the Board of Directors of the Community Oncology Alliance (COA), the purpose of this letter is to provide you and the Oncology Care Model (“OCM”) Center for

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April 2019

COA Comments on Proposal to Remove the Safe Harbor Protection From the Federal Anti-Kickback Statute

Submitted electronically to: http://www.regulations.gov The Honorable Alex M. Azar II Secretary United States Department of Health and Human Services Attention: OIG-0936-P 200 Independence Avenue, SW Room 600E Washington, DC 20201 Re: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale

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April 2019

COA Biosimilars Position Statement

Summary: The Community Oncology Alliance (COA) is committed to advancing knowledge and acceptance of biosimilars as an important, promising element in reducing drug costs and overall health care spending, and the financial toxicity of cancer care for patients. COA will work to support biosimilars and innovative biosimilar (biologic) development with all stakeholders, including policymakers,

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March 2019

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

The Honorable Seema Verma, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CAG-00451N P.O. Box 8013 Baltimore, MD 21244-801 Re: Proposed Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers; CAG-00451N Dear Administrator Verma: On behalf of the Board of Directors of the Community Oncology Alliance

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February 2019

COA Letter on the Patient Affordability, Value and Efficiency (PAVE) Act

Senator Bill Cassidy 520 Hart Senate Office Building Washington, DC 20510 Senator Mark Warner 703 Hart Senate Office Building Washington, DC 20510 Re: The Patient Affordability, Value and Efficiency Act Dear Senators Cassidy and Warner: On behalf of the Board of Directors of the Community Oncology Alliance (COA), we thank you for the opportunity to

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January 2019

COA comment letter on CMS plans to “modernize” the Part D program and Medicare Advantage (MA) plans

Submitted electronically to: http://www.regulations.gov The Honorable Seema Verma, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-4180-P P.O. Box 8013 Baltimore, MD 21244-8013 Re: Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses; CMS-4180-P Dear Administrator Verma: On behalf of the

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December 2018

COA Comments on IPI for Medicare Part B Drugs

The Honorable Seema Verma, Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-5528-ANPRM P.O. Box 8016 Baltimore, MD 21244-8013 Re: Medicare Program; International Pricing Index Model for Medicare Part B Drugs; CMS-5528- ANPRM Dear Administrator Verma: On behalf of the Board of Directors of the Community Oncology Alliance

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December 2018

COA Comments Objecting to CVS-Aetna Merger

Peter Mucchetti, Esq. Peter.J.Mucchetti@usdoj.gov Antitrust.atr@usdoj.gov Chief, Healthcare and Consumer Products Section, Antitrust Division, Department of Justice 450 Fifth Street NW, Suite 4100 Washington, DC 20530 RE: United States of America v. CVS Health Corporation and Aetna Inc. Dkt. No.: 1:18-cv-02340 Dear Mr. Mucchetti: The Community Oncology Alliance (“COA”) submits this letter on behalf of

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November 2018

COA Comments on Revisions to USP General Chapter 797 Pharmaceutical Compounding – Sterile Preparations

Submitted electronically to: CompoundingSL@usp.org Ronald T. Piervincenzi, Ph.D. Chief Executive Officer U.S. Pharmacopeial Convention 12601 Twinbrook Parkway Rockville, MD 20852-1790 Re: Comments to Proposed Revisions to USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations Dear Dr. Piervincenzi, On behalf of the Board of Directors of the Community Oncology Alliance (COA), we thank you

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