American Medical News
Posted May 27, 2013
The final regulations of the Sunshine Act, covering pharmaceutical and device companies’ financial relationships with physicians, have been disclosed. On Aug. 1, manufacturers will begin collecting data on payments to doctors, and by Sept. 30, 2014, the Centers for Medicare & Medicaid Services will post that information online.
Such transparency can be a good thing — if done right. While the American Medical Association largely has shown support for the initial designs for data collection under the Sunshine Act, the AMA and other medical organizations still have great concerns over some aspects. As is, the system threatens to expose physicians to identity theft or data breaches, unfairly depict physician-manufacturer interaction and place undue administrative burdens on doctors.
Organized medicine is engaged in educating doctors on the Sunshine Act. The AMA, specifically, has resources available online and plans an educational session at its June Annual Meeting. It will feature Shantanu Agrawal, MD, medical director for the Center for Program Integrity, the CMS anti-fraud unit carrying out the Sunshine Act.
But the AMA and others also are advocating changes to CMS. Those improvements would enhance the accuracy and fairness of information it posts and help ensure that the Sunshine Act stays consistent with its congressional stated purpose: providing transparency without undermining interactions that advance medicine.
A quick review: The Sunshine Act, part of the Affordable Care Act, requires makers of drugs, medical devices and biologicals that participate in U.S. federal health programs to report any individual payments and transfers of value of at least $10 given to doctors and teaching hospitals, or multiple transfers of less than $10 each if they cumulatively reach $100. Manufacturers also must list any physicians, or their immediate family members, who hold an ownership interest. Drug samples and educational materials intended for patients are among the items exempt from reporting. CMS can levy fines of up to $10,000 on manufacturers failing to report gifts, and up to $100,000 if they knowingly omitted such information.
Before the information is posted, physicians get 45 days to review the manufacturers’ submissions. Manufacturers then have 15 days to correct any misinformation. If a manufacturer disputes a doctor’s revisions, that information will be flagged, though it still will be posted publicly. Doctors also can seek corrections or contest reports for two years after access has been provided to them.
In an April 9 letter to CMS, AMA Executive Vice President and CEO James L. Madara, MD, highlighted three particular areas of concern with Sunshine Act reporting rules as they now stand.
The first concern centers on the level of personal data about physicians that is submitted and reported. Dr. Madara’s letter asks CMS to limit personally identifiable physician information only at the level required by the act. If too much personal information is collected and submitted, it could leave doctors vulnerable to data breaches and identity theft. Dr. Madara also pointed out that allowing industry to include physician email addresses could cause confusion and undermine attempts to notify doctors under the Sunshine Act, because those addresses may be different from, for example, what a doctor used to register for the CMS portal.
The second concern has to do with physicians’ inability to add contextual information to industry reports. Dr. Madara noted that the final Sunshine Act regulations did not prohibit physicians from getting the chance to make comments regarding their reports. With that in mind, CMS should allow this on all three templates — research, nonresearch and physician ownership — it is using to report payments or transfers of value. This way, the reports would be accurate, fair and balanced.
The third concern centers on who in a physician practice would review manufacturers’ reports. At this point, Sunshine Act registration, review and challenges must be done by the physician. However, the AMA is urging CMS to allow an authorized third party, such as a practice manager, to assist physicians and help reduce their administrative burden. Dr. Madara cited other stakeholders pointing out that CMS allows this option for such tasks as quality reporting and Medicare enrollment.
CMS is reviewing letters by the AMA and others that raise similar points. It is expected that CMS will address at least some of the issues in the frequently asked questions portion of its Sunshine Act website, which is being used to clarify points not readily apparent in the final regulations.
The transparency being sought by the Sunshine Act is a noble goal, one that can create an open conversation between doctors and patients as to why these relationships exist with industry, and how they can benefit care. But transparency also requires context, ensuring that patients who want that discussion have the most accurate information — not just what and how much, but also why.