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PFDD: BIO Comments on FDA Draft Guidance Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

March 21, 2019

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BIO Submits Comments Re: Medicare CY 2020 Part D Draft Call Letter

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 To that end, we provide comments in the following areas: The specialty tier is an outdated approach that presents risks for vulnerable beneficiaries and should be re-evaluated; Coinsurance in the Part D non-preferred drug tier can unduly limit access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.

BIO Submits Comments re: Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule

On January 25, BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS') Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses Proposed Rule. BIO is extremely concerned to see the Agency continue to focus on policy changes that erode the value of the Medicare benefit for seniors, placing patient access at risk. This Proposed Rule is yet another in a series of proposals that prioritize cost containment policies over patient healthcare needs. BIO respectfully requests that the Agency and Administration instead focus on holistic solutions that balance the financial sustainability of the Medicare program, while addressing patient out-of-pocket cost and access to appropriate treatment. Our concerns, detailed further in the balance of this letter, focus on the following: I. CMS should not allow plans to restrict access in the Medicare Part D six protected classes, as plans already have flexibility to manage these drugs in a clinically appropriate manner. II. CMS must go further in protecting beneficiaries enrolled in Medicare Advantage who may be subject to step therapy for their Part B drugs. III. CMS should not move forward with the inclusion of drug pricing information in the explanation of benefits, and instead focus on the updates to e-Prescribing standard to appropriately share cost information. IV. CMS must continue to work to ensure that patients see the benefit of negotiated prices reflected in their out-of-pocket (OOP) costs. V. CMS should move forward with the proposed requirements prohibiting gag clauses.

BIO Applauds Bipartisan Senate Letter on U.S.-China Trade Negotiations

BIO President and CEO Jim Greenwood today applauded a letter authored by Senators Pat Roberts (R-Kan.) and Debbie Stabenow (D-Mich.) to President Trump urging him to continue prioritizing in U.S.-China trade negotiations the need for China to commit to systemic change and implement a predictable, timely, transparent, and science-based biotech crop approval process. 

BIO Applauds Trump Administration for Moving Closer to Fulfilling E15 Promise

The Biotechnology Innovation Organization (BIO) released the following statement after the U.S. Environmental Protection Agency (EPA) announced its proposed rule allowing for the summertime use of E15 gasoline.

BIO Urges Congress to Extend Biofuels Tax Incentives

The Biotechnology Innovation Organization BIO today submitted the following statement for the record to the House Ways and Means Subcommittee on Select Revenue Measures urging Congress to retroactively extend the biofuels tax incentives that expired at the end of 2017. The subcommittee today held a hearing entitled “Temporary Policy in the Internal Revenue Code.”

BIO Statement on President’s Proposed 2020 Budget

Washington, DC (March 11, 2019) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement today regarding President Trump’s FY 2020 budget proposal:

BIO Applauds FDA Action on AquAdvantage® Salmon

The Biotechnology Innovation Organization (BIO) released the following statement on the action taken today by the U.S. Food & Drug Administration (FDA) which will allow AquaBounty Technologies, an American company, to commercialize its genetically engineered AquAdvantage® Salmon in the U.S. market.

BIO Applauds Multi-Agency Framework for Advancing the Bioeconomy

The Biotechnology Innovation Organization (BIO) today released the following statement in response to the release of The Bioeconomy Initiative: Implementation Framework, a multi-agency strategy aimed at accelerating innovative technologies that harness the nation’s biomass resources for affordable biofuels, bioproducts, and biopower:

BIO Statement on Ambassador Lighthizer and Secretary Perdue Testimonies

BIO President and CEO Jim Greenwood released the following statement on U.S. Trade Representative Robert Lighthizer’s testimony at a House Ways and Means Committee hearing on the U.S.-China trade deal and U.S. Secretary of Agriculture Sonny Perdue’s testimony at a House Agriculture Committee hearing on the state of the rural economy.