BIO Submits Comments Re: CY 2019 Medicare Advantage and Part D Call Letter

Dear Administrator Verma,

The Biotechnology Innovation Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 draft Call Letter (Draft Call Letter).1 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. Our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

BIO supports CMS’s commitment to improving the quality and delivery of care in the MA and Part D programs. We believe it is critically important to ensure that policies in these programs advance patient access to timely and appropriate treatment, particularly for prescription drugs and vaccines. To that end, we provide comments in the following areas:

The specialty tier eligibility cost threshold should be increased for 2019 and in future years and the exceptions process expanded to ensure that the specialty tier does not discriminate against vulnerable beneficiaries;

•  Co-insurance in the Part D non-preferred drug tier can unduly limit access to care for patients with severe and complex diseases;
•  Increased enforcement of nondiscrimination should be used when evaluating benefit design in the MA and Part D programs;
•  Access to innovative treatment options for pain and addiction should be prioritized as a part of addressing opioid overutilization in MA Part D plans;
•  MA and Part D plans should prioritize and increase access to vaccinations for Medicare beneficiaries;
•  The timeframes and processes for formulary updates should support the inclusion of new therapies;
•  Drug tier labels should be accurately reflective of the tier’s composition.
•  The inclusion of prescription drug costs in Medicare advantage uniformity flexibility should provide patient access to the most appropriate treatment;
•  Additional flexibility in design of maximum out-of-pocket costs should be considered to assist beneficiaries;
•  The availability of suitable plan offerings should be increased through removal of the meaningful difference requirements;
•      Additions to the Star Ratings are critical to accurate assessment of patient care quality; and
•  Efforts to expand coverage for certain subsets of products MA-PD plans should focus across all drugs offered under the Part D program.