In just two weeks, drug and device manufacturers will be required to start tracking and collecting data in connection with the Physician Payments Sunshine Act, which CMS refers to as the Open Payments program. Available data suggests that while manufacturers are generally prepared, physicians may not be aware of the reporting requirements or may not fully appreciate the scope of the new rules (see here).
As of August 1, 2013, applicable drug and device manufacturers (the regulatory definition of which includes most medical device distributors) will be obligated to track payments across 15 separate categories, as well as research payments. Group Purchasing Organizations (including Physician Owned Distributors) will be required to reporting ownership and investment interests.
Since the belated publication of the PPSA final rule in February, CMS has issued a number of communications relevant to physicians, many of whom are just now becoming aware of the Sunshine Act. This blog post reviews several relevant developments.
First, CMS in May issued the “templates” that manufacturers will use to report information. The payment templates provide a useful “list” of the information that physicians can expect to see reported by the manufacturers and distributors who call on them. The template for general non-research payments is here. The template for research payments is here.
Second, CMS has issued several rounds of FAQs (compiled here) to assist in clarifying some of the many non-obvious (and some obvious) aspects of the final rule. Several of the answers may be useful for physicians who are wondering what types of “transfers of value” will be reported:
- CMS has set a de minimis payment threshold of $10 per transaction or $100 annually. In order to determine if manufacturer has met $100 threshold, should payments be aggregated across different categories?
- Yes – 6 hotdogs ($9) plus 3 minor league games ($9) plus 3 cab fares ($9) would trigger the reporting threshold amounts.
- If a manufacturer serves a buffet meal in connection with a company-sponsored presentation scheduled in conjunction with a large annual conference (e.g., ASCO), will the value of the meal be reported?
- The answer depends on whether it would be difficult to identify the meeting/meal participants. The transfer of value may appear on report if it is a smaller meeting such that it would be reasonable to expect the manufacturer to be able to identify the attendees.
- Will the value of journal reprints provided to physicians be reported?
- Yes – CMS has instructed that manufacturers should report the cost paid to acquire the reprint divided by the number of individual recipients.
- If a physician interviews for a job with an applicable manufacturer, will the expenses associated with the interview be reported?
- Yes, travel, lodging and other expenses associated with an interview will be reportable.
As the answers to the FAQs make clear, the CMS website will contain information regarding transfers of value that would not be readily apparent to many recipients.
Finally, CMS recently issued two “apps” (for both iPhone and Android operating systems) to assist both physicians and industry participants in tracking payment information. The Policy and Medicine website (PolicyMed.com) – a key go-to resource for all things Sunshine – provided a thorough review, including some apt concerns about security and the potential for creating subpoena-able records. See here.
After downloading both apps and playing with them a bit, it seems unlikely that they will make the “most uploaded” lists anytime soon, at least in their current iterations. The security issues are considerable, particularly as the “permissions” include typically onerous app provisions permitting access to most elements of the personal device. Moreover, the available mechanism to export the information is through associated email accounts. The app itself warns that exporting data in that manner may not be secure. As PolicyMed suggests, perhaps a commercial developer will release an app that addresses some of these issues. In the meantime, the CMS apps, at least in version 1.0, are not optimal vehicles for tracking physician payment data. However, as it is not necessary to complete all fields in order to save information regarding a transaction, the apps may be useful as a place to maintain a list of relevant transactions for later reference.