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.

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”).   
March 27 2014
VIA ELECTRONIC SUBMISSION   March 1, 2014     Patrick Conway, M.D. Deputy Administrator for Innovation and Quality Chief Medical Officer Centers for Medicare & Medicaid Services Center for Medicare and Medicaid Innovation 7500 Security Boulevard Baltimore, MD 21244   RE: Request for Information: Evolution of ACO Initiatives at CMS   Dear Dr. Conway:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments regarding the Request for Information (RFI) on the “Evolution of ACO Initiatives at CMS” released by the Center for Medicare and Medicaid Innovation (CMMI) on December 20, 2013.[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, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. [1]           Center for Medicare and Medicaid Innovation, Request for Information: Evolution of ACO Initiatives at CMS (Dec. 20, 2013), available at: http://innovation.cms.gov/Files/x/Pioneer-RFI.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.    
January 31 2014
Dear Ms. Badrov:   The Biotechnology Industry Organization (BIO) and the Illinois Biotechnology Industry Organization (iBIO) appreciate this opportunity to comment on the Illinois Department of Healthcare and Family Services (the “Department”) proposed rule to amend 89 Ill. Adm. Code 140 regarding the 340B Drug Discount Program (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.  In Illinois BIO works in collaboration with iBIO, whose membership includes strong representation from the bio-pharmaceutical sector.  This sector accounts for a large portion of the $98 billion in biotech annual economic output and 369,000 directly and indirectly-created jobs in the state.  
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.
January 6 2011
BIO releases a report by Health Advances on the limitations of the nation’s reimbursement system for novel diagnostics and the impact of these limitations.