Within the Affordable Care Act (ACA) is Section 6002, which requires the public reporting of payments or other value transfers made to physicians and teaching hospitals by manufacturers and group purchasing organizations of drugs, devices, biologicals, and medical supplies that are covered by Medicare, Medicaid or the Children’s Health Insurance Program.
Under this provision, known as the Physician Payment Sunshine Act, the Secretary of the U.S. Department of Health and Human Services (HHS) is responsible for establishing procedures for the submission of the information as well as its public availability. Consequently, the Centers for Medicare & Medicaid Services (CMS) recently announced that it is “in the process of identifying and analyzing key processes and requirements to ensure the effective implementation of this provision.”
CMS will be holding a Conference Call Only “Special Open Door Forum on Transparency Reports and Reporting of Physician Ownership or Investment Interests.”
Date: Thursday, March 24, 2011
Time: 2:00PM – 4:00PM EST
Number: 1-800-837-1935
Conference ID: 51513526
CMS noted that it is seeking stakeholder input on a number of topics defined in the statute including:
- Comments on additional forms and natures of payment and transfer of value to be considered by HHS.
- Accessibility to and usability of the reported data by consumers.
- Mechanisms for accurate, efficient, and cost-effective reporting of data.
Specifically CMS is interested in feedback regarding:
Other forms of payment or transfer of value: The legislation lists specific forms of payment or other transfer of value that applicable manufacturers are required to report: Cash or cash equivalent; in-kind items or services; stock, a stock option, or any other ownership interest, dividend, profit, or other return on investment. In addition, the Secretary can define additional forms of payment or other transfers of value to require of manufacturers to report.
- Should CMS consider additional forms of payment or transfers of value?
- If so, what additional forms should CMS consider and what additive value do they bring?
Definitions of nature of payment or other transfers of value: The legislation lists 14 specific natures of payment and transfers of value that applicable manufacturers are required to report. These include: consulting fees, compensation for services other than consulting, honoraria, gift, entertainment, food, travel (including specified destinations), education, research, charitable contribution, royalty or license, current or prospective ownership or investment interest, direct compensation for serving as faculty or speaker for a medical education program, and grant. The Secretary can define additional natures of payment or transfers of value.
- Should CMS consider additional natures of payment or transfers of value?
- If so, what additional natures of payment or transfers of value should CMS consider and what additive value do they bring?
- How narrowly or broadly should CMS define the nature of payments/transfers of value listed in the legislation? For example, what types of consulting should CMS specify (if at all). Please provide examples.
Additional categories of information to report: Beyond the categories listed in the statute, such as forms and nature of payment, the Secretary can determine additional categories of information regarding the payment or other transfer of value to require of the manufacturers to report.
- Should CMS consider additional categories of information to report?
- If so, what additional categories should CMS consider requiring and what additive value do they bring?
Ownership or investment interest: The Secretary can determine whether to require additional information regarding physician ownership or investment interest.
- Should CMS require additional information regarding physician ownership or investment interests?
- If so, what additional information regarding physician ownership or investment interest should CMS consider and what additive value do they bring?
Average consumer information: What additional types of information should CMS consider reporting to the public beyond forms and natures of payment or transfers of value and physician ownership in applicable manufacturers and group purchasing organizations?
- What types of background information on industry-physician relationships should CMS consider including?
- What are best practice approaches for presenting the data in a way that is most understandable by consumers? How can CMS maximize the use of data reported on the website?
Reporting of data: What types of approaches/mechanisms should CMS consider to ensure accurate, efficient, and cost-effective reporting of data?
- Electronic form: What electronic form should submissions take? What types of electronic forms are currently available that CMS can leverage or use as a model for the purposes of satisfying this requirement? (e.g., electronic forms used by states with sunshine laws)
- Corrections of reported information. What procedures should CMS establish for the correction of mistakes in the reported data provided by manufacturers?
CMS noted that it will try to provide everyone with the opportunity give feedback during the call; however, participants are also encouraged to submit additional thoughts or feedback following the session to an email address established for this purpose: physiciansunshine@cms.hhs.gov.
Special Open Door Forum Participation Instructions:
**Capacity is limited so dial in early. You may begin dialing into this forum as early as 1:45PM EST. ** Dial 1-800-837-1935 Conference ID 51513526.
An audio recording and transcript of this call will be posted to the Special Open Door Forum website and will be accessible for downloading beginning on or around April 21, 2011.
Discussion
The Physician Payment Sunshine Act has the potential to bring about a systemic shift in the health care industry, with government taking a larger roll in care of patients. For CME, grants will be reported if they are requested on behalf of a specific physician and/or are given to a teaching hospital.
Many stakeholders in the CME community and healthcare industry have a large interest in ensuring that the reporting requirements under the Sunshine Act are clear, logical, and common sense. We encourage as many people as possible to submit their comments to CMS and to participate in the conference call.