Reimbursement and Health Policy

Personalized medicine has the potential to revolutionize patient care. The fundamental goal in advancing our healthcare system through personalized medicine is to deliver the right treatment to the right patient at the right time.

Biotech research holds a great deal of promise for future innovation in the treatment of previously untreatable diseases. But how long does it take for a biotech therapy to come to market?

Biotechnology is all around us and is already a big part of our lives, providing breakthrough products and technologies to combat disease, reduce our environmental footprint, feed the hungry, and make useful products.

Biosimilars, also known as follow-on biologics, may eventually expand access and provide patients a more affordable alternative to innovative, lifesaving medicines. 

Myths abound regarding data exclusivity and the ability of an innovator to extend the period of data exclusivity as provided in the health care reform bill passed by the U.S. House of Representatives and legislation currently under consideration in the Senate.

What's a stem cell? Where does it come from? Learn more about how biotechnology is utilizing stem cells to create tomorrow's cures for today's diseases.

The health reform debate is heating up and, in at least one respect, slowing down a bit.

During Tuesday's panel, we had the opportunity to lay the foundation of Medicare reimbursement policy, and discuss current trends and how health reform my impact reimbursement for biotechnology therapies in the future.

We have used the biological processes of microorganisms for 6,000 years to make useful food products, such as bread and cheese, and to preserve dairy products.

Today, the biotechnology industry is enjoying more success and influence than ever before. Our industry’s innovations continue to improve the lives of people worldwide, and the advancement of these innovations is supported by the work of BIO.

States and regions throughout the United States are investing to create a business climate that supports the specific needs of the biosciences sector.

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).  
June 11 2014
  June 10, 2014   Jacob J. Lew Secretary, Department of the Treasury 1500 Pennsylvania Avenue, NW Washington, D.C. 20220                               Thomas E. Perez Secretary, Department of Labor Frances Perkins Building, 200 Constitution Ave., NW, Washington, DC 20210   Sylvia Mathews Burwell Secretary, Department of Health and Human Services 200 Independence Avenue, SW Washington, DC 20201   Re: Request for Information Regarding Provider Nondiscrimination   Dear Secretaries Lew, Perez, and Burwell:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the “Request for Information Regarding Provider Nondiscrimination” (the “RFI”) issued by the Departments of Treasury, Labor, and Health and Human Services (“the Departments”) on March 12, 2014.[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 health care expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. [1] 79 Fed. Reg. 14,052 (March 12, 2014).  
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 28 2014
March 15, 2013   Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201   Re: Affordable Exchanges Guidance: Letter to Issuers on Federally-facilitated and State Partnership Exchanges   Dear Ms. Tavenner:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the draft Letter related to the Patient Protection and Affordable Care Act’s (PPACA) health insurance Exchanges that the Centers for Medicare & Medicaid Services (CMS) issued on March 1, 2013, entitled “Letter to Issuers on Federally-facilitated and State Partnership Exchanges” (the “Letter”).1 BIO represents more than 1,100 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 case. 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 health care expenditures due to fewer physician office visits, hospitalizations and surgical interventions.
March 27 2014
February 25, 2013     Marilyn Tavenner, B.S.N., M.H.A. Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201   Re: Draft 2015 Letter to Issuers on Federally-facilitated Marketplaces   Dear Ms. Tavenner:             The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the draft letter related to the Patient Protection and Affordable Care Act’s (ACA) health insurance Marketplaces that the Centers for Medicare & Medicaid Services (CMS) issued on February 4, 2014, entitled “Draft 2015 Letter to Issuers on Federally-facilitated Marketplaces” (the “Draft Letter”).[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 health care expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. [1] Center for Consumer Information and Insurance Oversight (CCIIO), Centers for Medicare & Medicaid Services (CMS), Draft 2015 Letter to Issuers in the Federally-facilitated Marketplaces (FFM) (Feb. 4, 2014). Available at: http://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/draft-issuer-letter-2-4-2014.pdf (hereinafter “Draft Letter to Issuers”).   
May 29 2014
Many participating hospitals appear to be deviating from the program’s original intent by leveraging 340B discounts for financial gain, rather than improving patient access
March 11 2014
BIO commended the Centers for Medicare & Medicaid Services (CMS) for announcing their decision to halt movement on several proposals in their Medicare Part D draft rule.
March 6 2012
BIO applauded the House Energy and Commerce Committee’s passage of the Medicare Decisions Accountability Act, H.R. 452, which would repeal the Independent Payment Advisory Board (IPAB) established in the health care reform law.
April 19 2011
Democratic and Republican party leaders and strategists will share their differing perspectives in a keynote panel, titled "The Future of Healthcare Reform," during a Keynote Luncheon at the 2011 BIO International Convention.
February 9 2011
BIO announces that former Senator John B. Breaux (D-LA), former Member, Senate Finance Committee, along with former Congressman Jim McCrery III (R-LA), former Ranking Member, House Ways & Means Committee, will be panelists at the 13th Annual BIO CEO & Investor Conference.