"Physician"

In defining the term "physician," both the statute and the proposed rule referred to section 1861(r) of the Social Security Act ("Act"), which defines "physician" to include doctors of medicine and osteopathy, dentists, podiatrists, optometrists and licensed chiropractors. The Sunshine Act requires manufacturers to report, "the specialty and National Provider Identifier of covered recipient[s who are physicians]." 42 U.S.C. §1320a-7h(a)(1)(A)(ii). CMS's proposed rule suggests that manufacturers use the National Plan & Provider Enumeration System ("NPPES") database of physician NPIs to report NPI, as well as the "provider taxonomy" field of the NPPES database to report a physician's specialty. Regarding those physicians not listed in the NPPES, CMS will likely require that manufacturers obtain NPIs directly from the physicians. CMS also requested comments on whether it should use a different unique identifier for a physician that does not have NPIs.
 
CMS's proposals regarding use of the NPI have not drawn any particularly vociferous industry reactions – neither from the manufacturers nor from physicians or hospital groups. At the same time, some manufacturers did express concern about the quality and correctness of the data in the NPPES, requesting that CMS notify manufacturers of updates to the NPPES (analogues to what certain states requiring transparency reports currently do), or otherwise publish a complete list of all covered recipients' NPIs and specialties that manufacturers can rely on throughout each tracking year.
 
While the industry comments agree – on balance –that the NPI is the appropriate identifier to use (supplemented by state license numbers where appropriate), some of the larger industry groups recommend that CMS abandon the NPI and instead create and publish unique identifiers specifically for transparency reporting. The argument here is compelling: certain physicians may have more than one NPI, and multiple state licenses may lead to multiple "unique identifiers." Furthermore, some commenters noted that physician specialties listed in the "provider taxonomy" field may or may not be completely reliable. Taken together, these elements could lead to inconsistent and unhelpful reporting, which promises to negatively affect consumers' understanding of the true relationships between industry and physicians. Nevertheless, development and live-and-continuous-updating of an entirely new system of identifiers places an enormous burden on CMS – recall that it took CMS several years to fully implement the NPI. And allowing, as some commenters suggest, manufacturers to report their internal data relating to physician specialty will likely lead to the same problems with consistency.
 
Regarding which physicians to report on, some commenters recommend that CMS limit reporting only to those physicians who currently practice in the U.S. and who receive transfers of value for activities that occur in the U.S. It is not clear that CMS will adopt such a restriction, given CMS's perception of the marginal additional burden relating to collection of any additional data point weighed against the perceived utility of publishing all potentially relevant data to consumers.

"Teaching Hospital"

CMS proposed that the term "teaching hospital" include any hospital that received Indirect Medical Education ("IME") payments, direct Graduate Medical Education payments, or psychiatric hospitals IME payments "during the most recent year for which such information is available." Anticipating industry objections to the difficulty in determining whether any hospital had received such payments based on publicly available data, CMS proposed publishing a list of all "teaching hospitals" for which reporting will be required.
 
Commenters requested assurance that CMS's list would be the definitive list, and requested that CMS publish its list 90 days prior to each calendar year. Commenters also requested that CMS provide each hospital's tax identification number on the official list. According to such commenters, including that information will allow manufacturers to more easily verify and identify the specific institution with which they are interacting given the variation with respect to naming and abbreviation conventions in hospital names and in the various corporate components of corporate organizations that qualify as teaching hospitals. These appear to be reasonable suggestions, and we expect that CMS will adopt them. 

This article was prepared by Jeffrey Layne (rlayne@fulbright.com or 512 536 4593), Benjamin Koplin (bkoplin@fulbright.com or 512 536 2439) and Selina Spinos (sspinos@fulbright.com or 202 662 4536) from Fulbright's Health Care Practice Group.  

Learn more about Fulbright's Sunshine Act Task Force.