BIO supports CMS’ 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 To that end, we provide comments in the following areas: The specialty tier is an outdated approach that presents risks for vulnerable beneficiaries and should be re-evaluated; Coinsurance in the Part D non-preferred drug tier can unduly limit access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; 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; CMS must go further in protecting beneficiaries enrolled in Medicare Advantage who may be subject to step therapy; CMS should mitigate the impact of the increase in the out-of-pocket (OOP) threshold for CY 2020; MA plans should have the flexibility to determine what constitutes a chronic condition for purposes of providing special supplemental benefits for the chronically ill; Additional flexibility in design of maximum OOP costs should be considered to assist beneficiaries; Drug tier labels should accurately reflect the tier’s composition; Inclusion of additional measures in the Star Ratings are critical to accurate assessment of patient care and quality; Access to innovative treatment options for pain and addiction should be prioritized as a part of addressing opioid overutilization in MA and Part D plans.