Close

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 Selects Des Moines as Venue for the 2019 BIO World Congress on Industrial Biotechnology

The Biotechnology Innovation Organization (BIO) today announced the selection of Des Moines, Iowa, as the location for the 2019 BIO World Congress on Industrial Biotechnology. The event will be held July 8-11, 2019 and it will host industry executives, investors, policy makers and academics from around the world and will feature the BIO One-on-One Partnering™ system.

Orphan Drugs: BIO Comments on FDA Draft Guidance Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases

Re: Docket No. FDA-2017-D-6380: Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases

...

PFDD: BIO Comments on FDA Public Workshop on Patient-Focused Drug Development: Guidance 1- Collecting Comprehensive and Representative Input

Re: Docket No. FDA–2017-N-5896: Public Workshop: Patient-Focused Drug Development: Guidance 1- Collecting Comprehensive and Representative Input

...

BIO Comments on FDA Draft Guidance Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

Re: Docket ID: FDA-2017-D-6617: Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease

...

RMAT: BIO Submits Comments on FDA Draft Guidance Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

Re: Docket No. FDA-2017-D-6159: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions

...

Biofuel Advocates' Letter to EPA Administrator Pruitt on 2019 Cellulosic Volumes

As the U.S. EPA begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), a group of trade association advocates encourage the agency to take a renewed look at commercially ready cellulosic biofuels.

BIO Statement on President’s Proposed 2019 Budget

Washington, D.C. (February 13, 2018) — Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement in response to President Trump’s FY 2019 budget proposal.

BIO Expresses Strong Support for TRID Improvement Act

Legislation provides critical regulatory relief to small, pre-revenue emerging companies Washington, D.C. (February 12, 2018)— The Biotechnology Innovation Organization (BIO) announced its strong support today for H.R. 3978, the TRID Improvement Act. The bill includes a provision known as the Fostering Innovation Act, which offers much needed regulatory relief to small biotechnology firms.