Reimbursement and Health Policy

What happens in Washington influences biotechnology progress every bit as much as what happens on Wall Street or in the lab.

Has a member of your family been vaccinated against hepatitis B? Do you know someone who has diabetes? Has anyone in your family had heart disease?

Providers and policy makers must collectively address the profound effect the red-tape hassle can have on the practice of oncology.

The Medicare conference agreement conforms closely to BIO's principles, and the association urges Congress to act quickly and send the bill to the White House for the president's signature.

August 8 2014
June 30, 2014   BY ELECTRONIC DELIVERY   The Honorable 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; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2015 Rates; Quality Reporting Requirements for Specific Providers; Reasonable Compensation Equivalents for Physician Services in Excluded Teaching Hospitals; Provider Administrative Appeals and Judicial Review; Enforcement Provisions for Organ Transplant Centers; and Electronic Health Record (EHR) Incentive Program; Proposed Rule [CMS-1607-P]   Dear Administrator Tavenner:   The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2015 Rates Proposed Rule (“the Proposed Rule”), specifically with respect to the Hospital Inpatient Quality Reporting (IQR) Program and the Hospital Value-Based Purchasing (VBP) Program.[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 members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.  [1] 79 Fed. Reg. 27,978 (May 15, 2014).  
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.
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.