Life Science Compliance Update

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January 23, 2015

Physician Payment Sunshine Act: Bipartisan Members of Congress Introduce Bill to Exclude Educational Materials From Reporting, Including CME and Medical Texts

Sunshine picture

A new bill has been introduced that would exempt from Sunshine Act reporting educational materials and transfers relating to continuing medical education.

Congressmen Michael C. Burgess, M.D. (R-TX), Chairman of the House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade, and Peter DeFazio (D-OR) recently introduced the Protect Continuing Physician Education and Patient Care Act, H.R. 293. The bill is in response to the Physician Payment Sunshine Act’s “unintended consequence of over-burdensome reporting requirements that made access to educational materials for physicians difficult to obtain,” according to the accompanying Press Release. This bipartisan legislation "would allow physicians full access to the most up-to-date educational materials like textbooks and journals so they may deliver the best care.”

The new bill has a very important Democratic co-sponsor. Rep. Peter DeFazio (D-OR) introduced the Physician Payments Sunshine Act way back on March 13, 2008, which became a provision in the Affordable Care Act in 2010. Upon release of the Open Payments data in October 2014, DeFazio stated: “Every year, pharmaceutical companies and medical device manufacturers spend billions of dollars promoting their products…However, there’s a difference between educating doctors on the uses and effects of new drugs and devices, versus enticing healthcare professionals with lavish gifts.”

In his statement supporting this amendment to the Sunshine Act, Rep. Defrazio reiterates this difference: 

“While the Sunshine Act that Congress passed in 2010 is an absolutely essential tool to shine the light on the relationship between the pharmaceutical companies and physicians, our bill ensures the Sunshine Act won’t restrict a physician’s access to the latest medical research and training. This common sense fix is a win for America’s doctors and continuing medical education, but most importantly, for patients.”

H.R. 293 (View the language here) would make the Sunshine Act consistent with these goals. Currently there are 12 exclusions from Sunshine reporting, including de minimis payments (under $10) and product samples. In recent rules, the Centers for Medicare and Medicaid Services (CMS) has determined that both continuing medical education events and the distribution of medical textbooks and peer-reviewed journals were subject to reporting, making them less accessible to physicians.The statute would be updated to "ensure that medical practices and patient care would not be harmed," as follows:

Transparency Reports and Reporting of Physician Ownership or Investment Interests, Sec. 1128G. [42 U.S.C. 1320a-7h]

(B) Exclusions.—An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:

  • (iii) Educational materials that directly benefit patients or are intended for patient useincluding peer-reviewed journals, journal reprints, journal supplements, and medical textbooks;
  • (xiii) A transfer of anything of value to a covered recipient who is a physician if the thing of value is intended solely for purposes of providing continuing medical education to the physician.

An earlier bill, HR 5539, was introduced with the same language in September of 2014, but was not enacted. This will be an important bill going forward this time around as potential revisions to the Affordable Care Act--including the medical device tax and the definition of what constitutes a "work week"--have gained traction on both sides of the aisle. Furthermore, the Protect Continuing Physician Education and Patient Care Act has been supported by 128 different organizations, states the Press Release. 

“As someone who practiced medicine for nearly 30 years, I can attest that the assessments, treatments and procedures I learned in medical school were outdated by the end of my career with new advances in medicine,” Representative Burgess said. “As doctors, we are constantly studying new treatments and learning about new illnesses that did not exist even a few years ago. Without access to these materials, it could mean the difference between life and death of our patients. As a physician, I cannot allow that to happen. Our bill ensures it doesn’t have to.”

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