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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.

Office of the National Coordinator for Health Information Technology; Medicare Access and CHIP Reauthorization Act of 2015; Request for Information (RFI) Regarding Assessing Interoperability for MACRA

The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments in response to the Request for Information (RFI) Regarding Assessing Interoperability for MACRA (the “RFI”).1 BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

BIO Submits Comments Re: Medicare Program; Part B Drug Payment Model [CMS-1670-P]

The Biotechnology Innovation Organization appreciates this opportunity to submit comments on the Centers for Medicare and Medicaid Services’ proposed rule entitled Medicare Program; Part B Drug Payment Model...

Follow-Up on BIO’s Comments in Response to the ICER Value Framework

BIO Submits Comments Re: MIPS, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models RFI

RE: CMS Regarding Implementation of the Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models

BIO Submits Comments Re: HRSA's PPA Information Collection Request

Captain Krista M. Pedley, PharmD, M.S., USPHS, Director Office of Pharmacy Affairs Health Resources and Services Administration Department of Health and Human Services 5600 Fishers Lane, Parklawn Building, Mail Stop 10C-03 Rockville, Maryland 20857   BY ELECTRONIC SUBMISSION   Re: Proposed Information Collection: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations [OMB No. 0915-0327- Revision]   Dear Captain Pedley:   The Biotechnology Industry Organization (“BIO”) appreciates the opportunity to submit the following comments in response to the proposed Information Collection Request (“ICR”), issued by the Health Resources and Services Administration (“HRSA”) and published in the Federal Register on October 20, 2015, entitled Enrollment and Re- Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations [OMB No. 0915-0327- Revision] (the “Proposed ICR”).

BIO Submits Comments Re: HCP LAN APM Draft Framework

Alternative Payment Model Framework and Progress Tracking Work Group Health Care Payment Learning & Action Network U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201   BY ELECTRONIC DELIVERY   RE: Alternative Payment Models Framework Draft White Paper   Dear Alternative Payment Model Framework and Progress Tracking Work Group:   The Biotechnology Industry Organization (BIO) is pleased to submit feedback in response to the U.S. Department of Health and Human Services’ (HHS’s) Health Care Payment and Learning Action Network’s (HCP LAN) “Alternative Payment Models Framework Draft White Paper” (the “Draft White Paper”), released on October 22, 2015.1 BIO represents biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

BIO Submits Comments Re: HHS Notice of Benefit and Payment Parameters for 2017

Sylvia Mathews Burwell Secretary U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201   Andrew M. Slavitt Acting Administrator Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, M.D. 21244   BY ELECTRONIC DELIVERY   Re: Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017 [CMS-9937-P]