Physician Payment Sunshine Act FAQs: Updated 12/2012
On what has ISMPP based the responses in this FAQ document?
What types of companies are covered by the Sunshine Act?
Who are the “covered recipients”?
What are the minimum reporting requirements?
Does reporting apply only to payments and activities associated with products that are available in the US?
Does it matter where the support was given from, eg, US or Europe?
When does reporting begin?
What happened during the open comment period, which allowed for a response to the proposed rules in the December 18, 2011, Federal Register?
What steps should I be taking now to prepare for and be able to respond to the Sunshine Act?
Is publication support covered by the Sunshine Act?
How should I respond to authors who are asking questions now about how this will impact them?
What is ISMPP doing to help its membership with respect to the Sunshine Act and publications?
On what has ISMPP based the responses in this FAQ document?
The responses in this FAQ have been developed from the information contained in section 1128G of the Patient Protection and Affordable Care Act (commonly referred to as the Physician Payment Sunshine Act or simply the Sunshine Act) and the proposed rules for implementation.1,2
Disclaimer: ISMPP is providing this information to assist our members in understanding some of the details of the Sunshine Act. It is not intended to provide legal guidance, and we recommend that readers consult the full guidance (see References) and your own legal counsel before acting on information provided in this document.
What types of companies are covered by the Sunshine Act?
The Sunshine Act requires “any applicable manufacturer that provides a payment or other transfer of value [to covered recipients] to report certain information to the Centers for Medicare and Medicaid Services (CMS), part of the US Department of Health and Human Services (DHHS), regarding those payments and other transfers of value.” Applicable manufacturers include all companies operating in the US that manufacture drugs, devices, biologics, or medical products that are reimbursable by the US Federal Government or are under common ownership of such companies.
Who are the “covered recipients”?
According to the proposed rules for implementation, covered recipients are defined as (1) US physicians (doctors of medicine and osteopathy, dentists, podiatrists, optometrists, and licensed chiropractors); however employees of applicable manufacturers are exempt; (2) US teaching hospitals.
What are the minimum reporting requirements?
The proposed regulations require that the following minimum information be reported:
1. Covered recipient’s name, address, specialty and national provider identifiers
2. Amount of payment or transfer of value
3. Date of payment
4. Associated covered drug, device, biologic or medical supply (where applicable)
5. Form of payment (selected from a pre-defined list)
6. Nature of payment (selected from a pre-defined list)
7. Third-party recipient, if applicable (eg, charitable contribution on behalf of a physician)
8. Ownership or investments associated with the applicable manufacturer (direct recipient and immediate family member[s])
Does reporting apply only to payments and activities associated with products that are available in the US?
No. The proposed rules suggest that reporting requirements will apply to all products, including those in development, if a company has one or more products available in the US.
Does it matter where the support was given from, eg, US or Europe?
No. The proposed rules suggest that the Sunshine Act will apply to all companies that manufacture products that are reimbursed by the US federal government, irrespective of geographic location, if they meet the definition of an ‘applicable manufacturer’, as outlined above.
When does reporting begin?
Reporting was originally intended to begin as of March 31, 2013, for information collected during 2012, and to continue for each full calendar year thereafter. Based on information learned from a September 2012 US government-convened roundtable meeting on the issue, CMS have stated that they are "hopeful that some data collection will occur in 2013."3 Thus it appears that there will be a substantial delay in the start date for reporting of Sunshine Act mandated data. The specific date in 2013 from which data will need to be collected is yet to be defined, and will depend on when the final regulations are issued and how much time is allowed within the regulations for companies to prepare for data collection.
We learned recently that CMS submitted final implementation rules to the US Office of Management and Budget at the end of November 2012. It is speculated that the final rules will be published within 90 days.
What happened during the open comment period, which allowed for a response to the proposed rules in the December 18, 2011, Federal Register?
The CMS received more than 300 comments during the open comment period, which were posted by wide range of stakeholders. The CMS has committed to reviewing the comments, and to including input from stakeholders as they write the final rules for implementation. As noted below, ISMPP was among the stakeholders who submitted a comment during the open comment period.
What steps should I be taking now to prepare for and be able to respond to the Sunshine Act?
The proposed CMS database will include extensive information. It is critical to set up a system now that allows for the tracking of this information
Is publication support covered by the Sunshine Act?
As of now, there are no specific requirements stated in the Sunshine Act with respect to support for publications. However, it is anticipated that publication assistance will be included in the final regulations for implementation.
How should I respond to authors who are asking questions now about how this will impact them?
It is suggested that you let the author know that there still is no clear guidance on this particular issue, and that you will update the author as soon as details become available. In the meantime, you hope that he/she will continue to work with you to ensure that data are available in an end-user-friendly format that will support clinicians in their clinical healthcare decision-making.
What is ISMPP doing to help its membership with respect to the Sunshine Act and publications?
ISMPP has established a Sunshine Act Task Force, details of which can be found at http://www.ismpp.org/sunshine-act-task-force. The remit of the Task Force is to follow the issues, understand the details and implications, and, most importantly, provide information and tools to our membership with respect to the Sunshine Act and medical publications.
Activities to date include
• Research, media and activities monitoring
• Response to the proposed rules in the December 18, 2011 Federal Register
• Publication of an article in the AMWA journal (March 2012 issue)
• Attendance at a meeting with CMS in collaboration with other stakeholders (May 14, 2012)
• Educational presentations at various industry venues
• Attendance at key industry and other associated meetings
Outputs from our various activities are available on the ISMPP website.
References
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Patient Protection and Affordable Care Act. 111 Congress HR 3590 2010:111-148. 2010.
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Department of Health and Human Services Federal Register. Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests. Available at www.gpo.gov/fdsys/pkg/FR-2011-12-19/pdf/2011-32244.pdf. Accessed January 11, 2012.
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Grassley on Delay in Implementing Physician Payments Sunshine Act. Available at www.grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=42419. Accessed November 12, 2012.
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