Letters, Testimony & Comments

          The Biotechnology Industry Organization (BIO) is pleased to submit the following...
December 21 2012
Dear Commissioner Hamburg: We are writing on behalf of the following higher education associations in consideration of issues raised...
November 5 2012
Re:  Patient-Centered Outcomes Research Institute (PCORI) Draft Methodology Report Dear Dr. Selby: The Biotechnology Industry...
September 14 2012
Re:      CMS-2345-P (Proposed Rule, Medicaid Program; Covered Outpatient Drugs) Dear Ms. Tavenner: The...
April 2 2012
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name...
March 29 2012
RE: Patient-Centered Outcomes Research Institute (PCORI) Draft National Priorities and Research Agenda Dear Dr. Selby:   ...
March 15 2012
Re: Draft 2013 Call Letter Dear Mr. Blum and Mr. Spitalnic: The Biotechnology Industry Organization (BIO) appreciates this...
March 2 2012
February 22, 2012 Texas Health and Human Services Commission Attn: Stacey Johnston Policy Analyst Medicaid/Children’s Health...
March 1 2012
BIO Public Statement: National Patient and Stakeholder Dialogue Thank you for the opportunity to present comments on behalf...
February 27 2012
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Department of Health and Human Services...
January 31 2012
Thank you for the opportunity to present comments on behalf of the innovative biotechnology industry which is working to prevent, treat,...
October 25 2011
RE:     June 29, 2011 Memorandum on Proposed Changes to the Medicare Coverage Gap Discount Program – Low-Volume...
August 1 2011
BIO’s comments addressed maters such as HRSA’s application of the exclusion, operational concerns arising from the proposed...
July 19 2011
Re: Proposed Guidance Regarding Branded Prescription Drug Fee [Notice 2011-9] Dear Mr. Commissioner: The Biotechnology Industry...
June 15 2011
Re: Medicare Program; Medicare Shared Saving Program: Accountable Care Organizations; Proposed Rule [CMS-1345-P] Dear Dr. Berwick:...
June 6 2011
Re: Proposed Guidance Regarding Branded Prescription Drug Fee [Notice 2011-9] Dear Mr. Commissioner: The Biotechnology Industry...
April 29 2011
Re: Comments on Section 6002 of the Affordable Care Act Dear Sir or Madam: BIO appreciates the opportunity to comment on the...
April 7 2011
Institute of Medicine Essential Health Benefits BIO Comments 1. What is your interpretation of the word “essential” in...
December 6 2010
Dear Ms. Maloy, As President and CEO of the Biotechnology Industry Organization (BIO) and on behalf of our more than 1,100...
September 30 2010
Re: Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient...
September 17 2010
BIO recommends that each grandfathered health plan disclose which insurance products it offers and cover preventive services and vaccines...
August 16 2010
BIO comments on the Medicare Coverage Gap Discount Program Draft Third Party Administrator Agreement (TPA Agreement) and the Draft Data...
July 16 2010
Re: Medicare Coverage Gap Discount Program Model Manufacturer Agreement – [CMS-4151-NC] RIN 0938-AQ04 Dear Administrator Tavenner...
June 21 2010
BIO supports the coverage gap discount program and believes that it will increase patient access to life-saving and life enhancing...
May 14 2010
July 31 2014
    July 17, 2014   BY ELECTRONIC DELIVERY   Mandy Cohen, M.D., MPH Acting Director, Center for Consumer Information and Insurance Oversight Centers for Medicare and Medicaid Services Department of Health and Human Services 200 Independence Avenue SW Washington, DC 20201   Re: Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market   Dear Dr. Cohen:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the notices issued by the Center for Consumer Information and Insurance Oversight (CCIIO) on June 26, 2014, entitled “Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market (the ‘Draft Standard Notices’).”[1]   BIO represents more than 1,000 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.[2] [1] Center for Consumer Information and Insurance Oversight (CCIIO), Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS), Insurance Standards Bulletin Series: Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market (2014). [2] See, e.g., Congressional Budget Office, Offsetting Effects of Prescription Drug Use on Medicare’s Spending for Medical Services (Nov. 2012).  
May 30 2014
April 10, 2014   BY ELECTRONIC DELIVERY   Marilyn B. Tavenner Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC 20201   Re: Patient Protection and Affordable Care Act; Exchange and Insurance Market Standards for 2015 and Beyond; Proposed Rule (CMS-9949-P)   Dear Administrator Tavenner:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the proposed rule issued by the Centers for Medicare & Medicaid Services (CMS) on March 21, 2014, entitled “Exchange and Insurance Market Standards for 2015 and Beyond” (the “Proposed Rule”).[1]   BIO represents more than 1,000 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.[2] [1] 79 Fed. Reg. 15,808 (March 21, 2014). [2] See, e.g., Congressional Budget Office, Offsetting Effects of Prescription Drug Use on Medicare’s Spending for Medical Services (Nov. 2012), available at: http://www.cbo.gov/sites/default/files/cbofiles/attachments/43741-MedicalOffsets-11-29-12.pdf.   
March 7 2014
  March 7, 2014   BY ELECTRONIC DELIVERY   Marilyn B. Tavenner Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC 20201   Re:  Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program; Proposed Rule [CMS-4159-P]   Dear Administrator Tavenner:   The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (the “Proposed Rule”). BIO is the largest trade association to serve and represent the biotechnology industry in the United States and around the globe.  Indeed, BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations.   BIO members are involved in the research and development of healthcare, agricultural, industrial, and environmental biotechnology products.    
November 5 2012
We write with the concern that under the statutory patent dispute resolution scheme, biosimilars sponsors can effectively circumvent every patent litigation provision of the statute simply by failing to provide timely notice and access to the reference product sponsor without meaningful consequences, despite the requirement for such notification. As universities are commonly licensors of biological products, numerous university patents may be affected by biosimilar applications. We do not believe it is appropriate that our member institutions’ rights could be forfeited due to an inadvertent or intentional failure by a biosimilar applicant to notify the reference product sponsor, who in turn can notify the university licensor.
October 28 2013
BIO responds to a Senators letter to FDA Commissioner Margaret Hamburg, regarding naming standards for biosimilars - drugs that are similar to, but not the same as the innovator drugs they seek to replicate.
June 28 2012
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement on the ruling issued today by the U.S. Supreme Court regarding the Affordable Care Act.
February 15 2012
The bill will modernize the FDA and accelerate patient access to cures and new treatments.
March 22 2010
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement after passage of “The Patient Protection and Affordable Care Act of 2009."