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BIO Submits Comments Re: Medicare CY 2019 Part D Proposed Rule

BIO supports CMS’s efforts to make changes to the Medicare Advantage, Medicare Fee-for-Service and the Part D Prescription Drug Benefit Programs in a manner that improves overall healthcare quality, while not compromising access to the most appropriate course of treatment. Our comments, detailed further in the balance of this letter, focus on the following areas:

  • Request for Information to Require Pass through of Manufacturer Rebates at the Point of Sale to the Beneficiary
  • Implementation of the Comprehensive Addiction and Recovery Act of 2016 (CARA)
  • Treatment of Follow-On Biological Products as Generics for Non-LIS Catastrophic and LIS Cost-Sharing
  • Revisions to Part D Tiering Exceptions
  • Expedited Substitutions of Certain Generics and Other Midyear Formulary Changes
  • Maximum Out-of-Pocket Limit and Cost-Sharing Limits for Medicare Parts A and B Services
  • Flexibility in the Medicare Advantage Uniformity Requirements
  • Any Willing Pharmacy Standards Terms and Conditions
  • Medicare Advantage and Part D Prescription Drug Program Quality Rating System
  • MA/Part D Artificial Limits

Dear Administrator Verma:

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs and the PACE Program Proposed Rule (proposed rule).

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. BIO membership includes biologics and vaccine manufacturers and developers who have worked closely with stakeholders across the spectrum, including the public health and advocacy communities, to support policies that help ensure access to innovative and life-saving medicines and vaccines for all individuals.

BIO supports CMS’s efforts to make changes to the Medicare Advantage, Medicare Fee-for-Service and the Part D Prescription Drug Benefit Programs in a manner that improves overall healthcare quality, while not compromising access to the most appropriate course of treatment. Our comments, detailed further in the balance of this letter, focus on the following areas:

  • Request for Information to Require Pass through of Manufacturer Rebates at the Point of Sale to the Beneficiary
  • Implementation of the Comprehensive Addiction and Recovery Act of 2016 (CARA)
  • Treatment of Follow-On Biological Products as Generics for Non-LIS Catastrophic and LIS Cost-Sharing
  • Revisions to Part D Tiering Exceptions
  • Expedited Substitutions of Certain Generics and Other Midyear Formulary Changes
  • Maximum Out-of-Pocket Limit and Cost-Sharing Limits for Medicare Parts A and B Services
  • Flexibility in the Medicare Advantage Uniformity Requirements
  • Any Willing Pharmacy Standards Terms and Conditions
  • Medicare Advantage and Part D Prescription Drug Program Quality Rating System
  • MA/Part D Artificial Limits