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

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.

BIO Applauds Introduction of the Ensuring the Value of the 340B Program Act of 2018

Washington, DC (March 1, 2018) – BIO President and CEO Jim Greenwood issued the following statement today regarding the introduction by Senator Charles Grassley of S. 2453, the Ensuring the Value of the 340B Program Act of 2018:

BIO Submits Comments Re: Medicare CY 2018 Part D Call Letter

BIO strongly supports CMS’s commitment to improving the quality of the Medicare Advantage (MA) and Part D programs. We consider it especially important to focus on policies that impact access to prescription drugs and biologicals for Medicare beneficiaries in MA and Part D plans. To further improve access to crucial therapies and immunizations for these patients, we urge CMS to consider the following comments, discussed in more detail below: Cost-sharing in the Part D specialty tier can unduly burden patients with severe, complex diseases and is exacerbated by the fact that the dollar-per-month threshold on the specialty tier allows a broad range of therapies to be included. While we appreciated the effort in 2017 toward increasing the threshold, BIO urges CMS to continue to substantially increase the threshold for 2018 and beyond. BIO also urges CMS to review the specialty tiers to ensure they do not discourage enrollment by certain Part D-eligible individuals. CMS should continue to seek information on the Part D tiering exceptions process and ensure that tiering structures do not impede beneficiary access to medically necessary and appropriate treatments. CMS should ensure that the timeframe and process for formulary updates reasonably allows for the addition of new therapies. CMS should work to make Medicare Plan Finder inclusive of the most up to date formulary information to best inform beneficiary prescription drug coverage choice. CMS should finalize the proposal to include a new display measure around the adjudication process and should continue efforts to further increase transparency around this process to provide patients with appropriate access to needed medicines. CMS should evaluate access to specialty pharmacies in considering network adequacy and patient access issues. CMS should continue to encourage increased beneficiary vaccination rates and ensure MA plans deem vaccinations provided by pharmacists, in accordance with state laws, as in-network providers for these services. CMS should finalize the movement of the High Risk Medication (HRM) measure from the Star Ratings to the display measures. CMS should ensure that innovative model testing in the Medicare program works to maintain or improve beneficiary access to appropriate care and treatment. CMS should look to include display measures consistent with the goals of the National Action Plan for Adverse Drug Event Prevention in future years. CMS should finalize the clarification around "reference-based pricing"2 in Part D beneficiary cost-sharing arrangements. CMS should look to further ensure market stabilization for the dually eligible population in Puerto Rico.

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

BIO Statement on House Energy & Commerce Committee 340B Drug Pricing Program Review

Washington, DC (January 10, 2018) – BIO President and CEO Jim Greenwood issued the following statement regarding the review of the 340B drug pricing program released by the House Energy & Commerce Committee today:

BIO Submits Comments Re: ICER Proposed Revisions to its Value Framework for Treatments for Ultra-Rare Diseases

BIO appreciates the opportunity to comment on these proposed revisions. Patients living with rare diseases often experience significant unmet medical need due to the lack of knowledge about how these diseases are caused or inherited and their progression. That those suffering from rare diseases are predominately children raises issues around how society prioritizes and develops treatments for these conditions. We believe there are significant challenges in reconciling existing population-level value assessment methodologies with the varied healthcare contexts and deeply personal patient-level treatment decisions faced by patients afflicted with rare diseases, their families, and their clinicians. For a number of reasons, applying a patient-centric lens when considering the value of treatment is especially important when considering rare diseases.

BIO Submits Comments Re: HHS Notice of Benefit and Payment Parameters for 2019

BIO submitted comments in response to the Department of Health and Human Services' Proposed Notice of Benefit and Payment Parameters for 2019. In its annual update of standards and requirements related to the exchanges and the health plans offered on them, HHS should strive for a policy framework that ensure access to health insurance also means access to appropriate care. We appreciate the work undertaken by HHS to develop and refine this framework since the inception of the Exchanges in 2014. But we believe more can and should be done. In this Notice, the Department proposes a number of modifications to foundational elements of the Exchanges – including significant changes to the ways States craft their essential health benefits (EHB) packages. We encourage the Department to carefully consider how these and other changes could impact the patient experience for those enrolled in health plans through the Exchanges.

BIO Submits Comments Re: CMS Innovation Center New Direction Request for Information

BIO submitted comments in response to the CMS Innovation Center New Direction Request for Information (RFI). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we have closely monitored the Innovation Center’s development and delivery of demonstration models and their potential impact on patient access to treatment and innovation. BIO applauds CMS for engaging in the collection of broad stakeholder feedback through this RFI, and not only for seeking input on the model focus areas, but also on the overarching principles that guide the Innovation Center’s activities (guiding principles). We support the Center for Medicare and Medicaid Innovation’s (CMMI’s) broader goal to improve quality of care and reduce overall healthcare expenditures, and believe appropriate access to, and utilization of, medicines can contribute to both goals. Innovative therapies have the potential to improve patient health outcomes and reduce healthcare spending in the short- and long-term. Thus, a prominent theme of our comments on this RFI center on the ideal that all demonstrations should not only maintain, but improve access to necessary therapies.

BIO Submits Comments Re: HHS Draft Strategic Plan FY 2018-2022

BIO submitted comments in response to the Health and Human Services (HHS/the Agency) Draft Strategic Plan for Fiscal Years 2018-2022. BIO strongly supports HHS’ mission to enhance the health and well-being of Americans, by providing for effective health and human services and by fostering sound, sustained advances in the science of underlying medicine, public health, and social services; and the associated strategic planning process.

BIO Submits Comments Re: USP Drug Classification System, Second Round of Public Comments

BIO submitted comments to the U.S. Pharmacopeial Convention (USP) Healthcare Quality and Safety Expert Committee (Expert Committee) in response to the second round of public comment on the USP Drug Classification System (USP DC), released September 25, 2017. In response to the USP DC, BIO offers comments consistent with our comprehensive comments on the draft Version 7.0 Medicare Model Guidelines (MMG) and comments on last year’s draft USP DC, both of which are included as appendices for the Expert Committee’s reference. Our comments, as follows, also correspond to the call for additional feedback on how to make the USP DC more user friendly as expressed on the open-mic web meeting.