Today, Representatives Michael Burgess (R-TX) and Allyson Schwartz (D-PA) introduced bipartisan legislation (H.R. 5539) to exempt medical textbooks and journals, as well as indirect payments that pharmaceutical and device manufacturers offer to CME providers, from Sunshine Act reporting requirements. The Sunshine Act lists as one of its exclusions "educational materials that directly benefit patients or are intended for patient use," which do not have to be reported. However, CMS has stated that they do not believe medical textbooks and journal articles fall within this educational carve out. CMS stated these items only have "downstream benefits" for patients as compared to "wall models and anatomical models," which are intended to be used with the patient and are excluded from reporting requirements.
Recently the American Medical Association (AMA) and over 100 medical societies wrote a letter to CMS stating: “The Agency’s decision to not cover these materials under the educational materials exclusion is inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients benefit directly from improved physician medical knowledge.” The AMA and co-signing associations also urged CMS to reconsider removing the CME exemption from the current Final Rule. They voiced their concern that revoking the reporting exclusion for CME would have a “significant chilling effect” on continuing education.
H.R. 5539 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.
H.R. 5539 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.
| HR 5539 |
