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BIO Comments on FDA voluntary labeling of GE salmon

Jan 26 2016
Food and Drug Administration Docket No. FDA-2015-D-4272; Food Labeling; Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon; Draft Guidance for Industry.

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

Dec 22 2015
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

Dec 22 2015
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

Dec 22 2015
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

Dec 22 2015
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]  

BIO Submits Comments Re: Methods for Assuring Access to Covered Medicaid Services Final Rule with Comment

Dec 22 2015
Andrew Slavitt Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC 20201   Re: Medicaid Program; Methods for Assuring Access to Covered Medicaid Services; Final Rule with Comment [CMS-2328-FC]   Dear Acting Administrator Slavitt:   The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) final rule with comment entitled Medicaid Program; Methods for Ensuring Access to Covered Medicaid Services; Final Rule with Comment (the "FC"). 

BIO Submits Comments Re: Data Metrics and Alternative Processes for Access to Care in the Medicaid Program RFI

Dec 22 2015
Andrew Slavitt Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC 20201   RE: Data Metrics and Alternative Processes for Access to Care in the Medicaid Program Request for Information [CMS-2328-NC]   Dear Acting Administrator Slavitt: The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS’s) Request for Information entitled Medicaid Program; Request for Information (RFI) – Data Metrics and Alternative Processes for Access to Care in the Medicaid Program (the "RFI"). 

BIO Submits Comments Re: Medicare Shared Savings Program: Accountable Care Organizations Proposed Rule

Dec 22 2015
Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence Avenue, S.W. Washington, D.C. 20201   Re: Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations   Dear Administrator Tavenner:   The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) proposed rule regarding the Medicare Shared Savings Program (MSSP) and Accountable Care Organizations (ACOs) (the “Proposed Rule”).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 members are involved in the research and development of health care, agricultural, industrial, and environmental biotechnology products.

BIO Submits Comments Re: MA Capitation Rates, Part C and Part D Payment Policies and 2016 Draft Call Letter

Dec 22 2015
Sean Cavanaugh Deputy Administrator Director, Center for Medicare Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 cc: Jennifer Wuggazer Lazio, F.S.A., M.A.A.A. Director Parts C & D Actuarial Group Office of the Actuary Re: Advance Notice of Methodological Changes for Calendar Year (CY) 2016 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter (“draft 2016 Call Letter”) Dear Mr. Cavanaugh: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) draft 2016 Call Letter. 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, including productivity and quality of life, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.  

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

Dec 22 2015
Andy Slavitt Acting Administrator Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, M.D. 22224 BY ELECTRONIC DELIVERY 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 Dear Acting Administrator Slavitt: The Biotechnology Industry Organization is pleased to submit feedback in response to the Centers for Medicare and Medicaid Services’ (CMS’s) Request for Information entitled “CMS Regarding Implementation of the Merit-Based Incentive Payment System (MIPS), Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models,” (the “RFI”) released October 1, 2015.