Yesterday, several physician organizations and pharmaceutical industry trade groups petitioned CMS to provide clarity on a number of important aspects of the Physician Payments Sunshine Act. Their letter argued for proper context surrounding industry payments, increased outreach to educate physicians about the Sunshine Act, and a simpler process for physicians looking to register with Open Payments. This article has been UPDATED following a PhRMA media outreach call on July 29, 2014.
Download the Letter to CMS here
PhRMA, Biotechnology Industry Organization, as well as societies for dermatologists, radiologists, orthopedists, plastic surgeons, and many more, pushed back against three aspects of the Sunshine Act that have proved particularly contentious in the past year.
(1) Context
The letter first addressed the fact that CMS should provide context when they release the data in September. “In reviewing the Medicare Part B data released earlier this year,” the letter states, “we note that the only information included and made available to the public was related to names and numbers with no context explaining the data. We do not believe this is an effective way to share data with the public and, in fact, can lead to confusion and misinterpretation.”
Indeed, in April this year, we found several news stories that seemingly failed to grasp the fact that Medicare payments often does not mean personal income for a doctor. CMS did little to educate the public beyond providing a large “data dump.” The letter notes that “multiple industry stakeholders have offered blueprints as to how context could be provided. To date, however, we have heard nothing from CMS regarding how the data will be explained. Given the importance of this outlying issue, we ask that CMS preview with physician stakeholders the proposed contextual information sought to accompany the public release of the Sunshine Act data.”
PhRMA assistant general counsel John Murphy spoke to Law360 earlier this week about the importance of context. The article states that physician-industry collaboration plays a key role in drug development. Physician payments may be related to consulting, research, education or a host of other purposes. “It would be too bad if everybody lumped that together into one number,” Murphy said.
Updated 7/29/2014 at noon after PhRMA Media Discussion: John Murphy reiterated the importance of context. He notes that no one yet knows what CMS’ database display will look like, but he hopes that CMS will provide a comprehensive discussion about what is being reported. People looking at the database should understand that payments are going to a variety of important causes, from: “research, collaboration, consulting, to developing new products,” Murphy states. As noted below, Wall Street Journal reports that CMS has already taken action to the stakeholder letter, stating that they do intend to provide some context to the payments.
(2) Physician Outreach
Second, the letter urges CMS to “increase the amount of educational efforts and outreach to physicians” regarding the Sunshine Act. “This includes more information on what will be reported, when it will be reported, what the reporting will look like, and how they can see what will be reported about them.”
The stakeholders have so far been displeased with the way CMS has handled its outreach. “For example, CMS announced only on Friday, July 11 that registration in the Open Payments system would open for physicians and teaching hospitals on Monday, July 14.”
The letter also pushes back against CMS’ recent proposal to change to Sunshine Act. “[T]he recent release of the proposed Physician Fee Schedule for 2015 includes additional changes to the Sunshine Act that may require industry stakeholders to disclose payments made to physicians speaking at Continuing Medical Education (CME) programs,” they state. “And while many of our organizations will provide CMS detailed comments related to this proposal, we nevertheless urge CMS to evaluate the unintended consequences this change could have on the medical education landscape in the United States.”
(3) Time Consuming Registration Process
Finally, the medical societies and trade groups call on CMS to simplify the registration on Open Payments: “Physicians we have spoken to are discouraged by the need to register twice to view data that is reported about them. This places a significant burden on physicians, who already have extremely busy schedules.”
Updated 7/29/2014 at noon after PhRMA Media Discussion: Robert E. Harbaugh, MD, FAANS, President, spoke to the specific problems with registration. Doctors are required to complete a multi-step process, and submit a variety of personal identifications, including their DEA number and social security number. Dr. Harbaugh notes that the “process has not been smooth.” As an example, he himself started the registration process yesterday, and is still waiting on a notification to begin step two.
The Letter concludes: “We call upon the Agency to increase their awareness efforts and also share with the provider community the number of physicians who have registered thus far. This will help us ascertain the extent to which additional efforts are needed to both increase physician awareness and potentially assist with registration.”
Wall Street Journal reports that: “A CMS spokesman wrote us late in the day to say the agency does plan to make available the nature of payment for each payment or transfer of value made to a physician or teaching hospital and will also include context on the website. CMS, he adds, also has an “extensive ongoing outreach campaign” underway to educate and inform physicians. As an example, the agency had mobile applications designed to help physicians track payments on a free download.”