BIO Comments on Implementation of Physician Transparency and Reporting Provisions of PPACA

BIO supports the goal of providing greater transparency regarding financial relationships with health care providers and believes that notice and comment rulemaking is necessary to fully and fairly address the issues raised by the statutory provisions. These issues are complex and largely of first impression in the federal arena.</p>

Re: Comments on Section 6002 of the Affordable Care Act

Dear Sir or Madam:

BIO appreciates the opportunity to comment on the implementation of the Physician Transparency and Reporting provisions enacted in 2010 as part of the Affordable Care Act (ACA). BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,100 members worldwide. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. Corporate members range from entrepreneurial companies developing a first product to Fortunate 500 multinationals. We also represent state and regional biotech associations, service providers to the industry, and academic centers.

General Comments

Section 6002 of the ACA requires manufacturers to report certain payments to physicians and teaching hospitals, beginning with data collected for the 2012 calendar year. BIO supports the goals of the ACA in providing greater transparency regarding financial relationships with healthcare providers. BIO recognizes the challenges faced by the Centers for Medicare & Medicaid Services (CMS) in implementing the statutory provisions requiring manufacturers to report payments or other transfers of value made to physicians and teaching hospitals. This challenge is particularly difficult because the statute requires that CMS must establish procedures for the submission of manufacturer reports by October 1, 2011. BIO hopes that CMS appreciates that manufacturers also face significant challenges in developing and implementing policies, procedures, and information systems to facilitate the mandatory collection of data that begins January 1, 2012.

BIO believes that the goals of the ACA will be best achieved by:

  • implementation of the statutory provisions with clear definitions and standards to ensure consistency in the collection, characterization and reporting of information;
  • interpretation of the statutory provisions to preclude duplicate reporting that might create confusion; and
  • provision of appropriate educational context to improve the public's understanding of the information provided and the need for collaboration between U.S. physicians and the life science industry