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BIO Submits Comments Re: Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule

BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS's) Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Proposed Policy Changes and Fiscal  Year 2018 Rates Proposed Rule on June 13, 2017. BIO supports the development and use of appropriate, evidence-based quality measures throughout the healthcare system as a component of improving efficiency and clinical outcomes; additionally, we support policy proposals driven at increasing access to innovative care. BIO's comments in the letter are divided into two sections - the first focusing on the proposals contained in the FY 2018 Proposed Rule, and the second for providing feedback on the Request for Information.

Democrats' Plan on Drug Costs a “Bad Deal for Patients and the Future of American Innovation”

Plan will restrict seniors’ access to prescription drugs and undermine quest for biopharmaceutical innovations and cures Washington, DC (July 24, 2017) – Biotechnology Innovation Organization (BIO) Director of Communications Brian Newell released the following statement regarding the drug cost plan released today by Congressional Democrats:

BIO Joins Diverse Coalition Promoting Market-Based Solutions to Address Prescription Drug Costs, Increase Patient Access and Choice

Washington, DC (May 17, 2017) – Today, the Biotechnology Innovation Organization (BIO) joins with a diverse coalition of stakeholders in endorsing a set of pro-competition,...

BIO Submits Comments Re: 340 B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (CMP) Regulation Interim Final Rule

BIO submitted comments in response to the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation Interim Final Rule (the "Interim Final Rule") published in the Federeal Register on March 20, 2017. In the balance of this letter, we discuss each of our concerns in detail, focusing on the need to delay the effective date of the Final Rule until HRSA can complete revisions to the Final Rule through notice-and-comment rulemaking that address: The significant burden of the “penny pricing” policy finalized in the Final Rule; The need to revise the regulatory definition of the “knowing and intentional” standard to comply with its statutory intent; and The need to revise the treatment of ceiling price calculations for newlylaunched drugs and the definition of “instances of overcharging” to mitigate the significant and undue burden these Final Rule provisions place on manufacturers.  

BIO Submits Comments Re: ICER Proposed Value Assessment Framework Revisions

BIO submitted comments on the Institute for Clinical and Economic Review (ICER)'s call for proposed improvements to its Value Assessment Framework. While some of the proposed revisions have the potential to make progress toward aligning the Framework with the principles of individualized patient care and holistic value assessment, ICER must provide additional details with regard to how these proposed revisions will be operationalized before stakeholders can assess whether the revisions will meaningfully address critical gaps in the Framework.

BIO Statement on MedPAC Vote

Washington, DC (April 6, 2017) – The Biotechnology Innovation Organization (BIO) issued the following statement regarding today's Medicare Payment Advisory Commission (MedPAC) vote:

BIO Statement on President Trump’s Comments Supporting Biopharmaceutical Competition and Innovation

Washington, DC (January 31, 2017) – BIO issued the following statement regarding President Trump’s comments today supporting biopharmaceutical innovation:

BIO Applauds Senate Passage of the 21st Century Cures Act

Washington, DC (December 7, 2016) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the 21st Century Cures Act by the U.S. Senate:

BIO Submits Comments Re: ICER Value Framework

BIO submitted comments on the Institute for Clinical and Economic Review (ICER) Value Assessment Framework. Throughout the attached letter, BIO addresses issues it has raised previously with the Framework as well as responds specifically to the four major categories of issues that the Institute identified (in the order in which they were identified). 

BIO Comments on Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule

BIO submitted comments on the Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule, which focused on several proposals related to, among other things, CMS’s review of New Technology Add-on Applications, the Hospital Value-Based Purchasing Program, the Hospital Inpatient Quality Reporting Program, the PPS-Exempt Cancer Hospital Quality Reporting Program, and the Long-Term Care Hospital Quality Reporting Program.