Life Science Compliance Update

October 28, 2014

Physician Payments Sunshine Act: Medical Societies Express Strong Support for H.R. 5539 To Exclude Education Materials From Reporting


Last month we wrote about a bipartisan effort in Congress 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. Click here for the text of H.R. 5539. Now, the AMA and dozens of physician organizations representing both national specialty societies and state medical societies have expressed their support of the bill. "H.R. is needed to ensure patients benefit from the most up-to-date and relevant medical knowledge," the letter states.

View the medical societies' letter to Representative Michael Burgess (R-TX), who introduced the bill. Allyson Schwartz (D-PA) co-sponsored. 

Congress outlined 12 specific exclusions from Sunshine Act reporting, including “[e]ducational materials that directly benefit patients or are intended for patient use.” In its interpretation of the statute, CMS concluded that medical textbooks, reprints of peer reviewed scientific clinical journal articles, and abstracts of these articles are not directly beneficial to patients, nor are they intended for patient use. "This conclusion 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," states the letter.

The American Medical Association and other physician organizations have repeatedly stressed the importance of up-to-date, peer reviewed scientific medical information as the foundation for patient care. "Scientific peer-reviewed journal reprints, supplements, and medical text books have long been considered essential tools for clinicians to remain informed about the latest in medical practice and patient care," the letter states. "Independent, peer reviewed medical textbooks and journal article supplements and reprints represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients because better informed clinicians render better care to their patients."

Furthermore, the letter states that FDA's reprint guidance underscores the “important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications.” H.R. 5539 clarifies that the Sunshine Act was designed to support the dissemination of this type of educational material.

The letter also addresses the Centers for Medicare and Medicaid Services (CMS) proposal to eliminate the continuing medical education exemption from the Act. "[This] proposal is inconsistent with the legislative history of the Sunshine Act and will further erode support of independent medical education," the societies note. "There is widespread consensus that the agency’s proposal will harm the dissemination of clinically relevant and critical medical knowledge that improves and enhances patient care. We strongly support the provisions in H.R. 5539 which would clarify that CME that meets the standard for independence must be exempt from Sunshine Act reporting." 

Click here for our article on the outpouring of support in favor of keeping the CME exemption. 


H.R. 5539 revises the Sunshine Act in the following way: 

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 use, including 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.


November 04, 2013

AAFP Postpones NP and PA Membership

The American Academy of Family Physicians (AAFP) recently announced its intent to study whether nurse practitioners (NPs) and physician assistants (PAs) should -- or would want to -- become nonvoting members. AAFP's Congress of Delegates decided not to create a new dues-paying membership category for NPs and PAs.

According to Medpage Today, AAFP's Reference Committee on Organization and Finance believed the number of allied health professionals that belong to other primary care physician organizations is small and that "the implementation cost would be significant for the small number of members that join the AAFP." The Committee also expressed concern "about the divisiveness of the issue for the physician-based organization, and noted the difficulty of tracking NPs and PAs to ensure they are working with an active AAFP member," Medpage reported.

Ultimately, the reference committee recommend the resolutions be referred to the AAFP Board of Directors for further study. The Congress of Delegates agreed.

Outgoing AAFP President Jeffrey Cain, MD, told MedPage Today the NP/PA-membership issue has come up previously.

Thomas Weida, MD, of Hershey, Pa., the delegate who introduced the resolutions on NPs and PAs, said he wanted to provide the allied health professionals access to AAFP's continuing medical education (CME) opportunities. "The academy has been founded on CME, and I think our CME is a high quality," Weida told MedPage Today. "We can then start working together on developing solutions to the challenges that face patients in care delivery and patient-centered medical homes."

This idea is increasingly important as many of the pillars of healthcare reform include team-based care, collaboration, and integration among healthcare providers—whether through the patient centered medical home (PCMH) or Accountable Care Organizations.

Moreover, the significant increase and influx of patients that will have health insurance over the next few years coupled with an unaddressed physician shortage leaves the possibility that NPs and PAs will fill those gaps—making interprofessional CME even more appealing.

Interprofessional CME is already a reality on the CME stakeholder side, with several CME providers receiving dual accreditation for physicians, nurses and/or pharmacists. Thus, the framework to offer interdisciplinary CME is already in place and can only be enhanced and improved as physicians, NPs and PAs work closely together to use the skills and knowledge they can gain from such education. Moreover, interprofessional CME may also offer unique opportunities for these healthcare providers to interact and exchange ideas and best practices for managing patient care.

The head of the American Academy of Physician Assistants strongly supported the measure, Weida said. He added that he was pleased with the result of Tuesday's action. Weida said that he did expect the resolution "to be accepted this first time around" but "the pendulum will swing as we realize the value of working together." Despite the resolution not being adopted, the AAFP maintained that NPs and PAs must work in teams with physicians and not independently.

Incoming AAFP President Reid Blackwelder, MD, told the Congress of Delegates in an address Monday that family physicians must work together -- not against -- NPs and PAs to meet patients' needs.

"Perhaps one of the most important aspects of this discussion is to recognize that ultimately the scope-of-practice issue is not a battle, it's not us against them, it's not good or bad, it's not right or wrong, even though this is often how the discussion is framed," Blackwelder said. "The truth is that each member of the team is critical and has important roles to play, but we are not interchangeable."



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