ACCME Receives Clarification from CMS Regarding Stark II Regulations
Upon request for clarification by the Accreditation Council for Continuing Medical Education (ACCME), the Centers for Medicare & Medicaid Services (CMS) responded about the application of Stark II regulations and CME that is delivered in the hospital setting. This clarification is consistent with the spirit of the ACCME’s 2006 Updated Accreditation Criteria which guide accredited Providers in the provision of CME that matters to patient care – CME that is based on professional practice gaps, designed to change the competence, performance or patient outcomes, and meets the scope of practice of the physician learners.
CMS says, “…we do not consider on-site CME to be remuneration if it is primarily for the benefit of the hospital’s patients, for example, training on the prevention of nosocomial infection.”
ACCME received the following from Donald H. Romano, Esquire, Director of the Division of Technical Payment Policy Center for Medicare Management, Centers for Medicare & Medicaid Services of the Department of Health and Human Services regarding the Stark II regulations:
“We understand the importance of ongoing CME in ensuring high quality patient care, and we recognize that some hospitals are willing to provide free or reduced cost CME in a manner that is convenient for physicians to remain currently apprised of developments in their areas of practice. We continue to abide by the statements of Herb B. Kuhn, Director, CMS Center for Medicare Management in his June 13, 2006 letter to ACCME that was intended to clarify such language. As stated in that letter, “traditional, on-site hospital grand rounds and other similar in-house education programs provided by hospitals are important and convenient ways for physicians to earn CME credit and for hospitals to ensure high quality patient care. We do not believe that such programs, which historically have been provided on-site at no charge, necessarily constitute remuneration to the physicians who attend them.” To clarify further, for purposes of our physician self-referral rules, we do not consider on-site CME to be remuneration if it is primarily for the benefit of the hospital’s patients, for example, training on the prevention of nosocomial infection. However, CME that is not primarily for the benefit of the hospital’s patients is considered remuneration. Where a hospital or physician is uncertain as to whether CME would be primarily for the benefit of the hospital’s patients, the hospital or physician may request an advisory opinion in accordance with the procedures set forth at 42 CFR section 411.370.
Moreover, to the extent that CME would constitute remuneration, there are several existing exceptions that may apply. The exceptions at 42 CFR sections 411.357(k) and (m) allow hospitals and other entities to provide non-monetary compensation up to $300 (updated for inflation), and medical staff incidental benefits of less than $25 (updated for inflation), and both such exceptions can cover grand rounds and other on-site CME. The exception at 42 CFR section 411.357 (n) allows hospitals and other entities to provide physicians with compliance training, including programs that offer CME credit, provided that compliance training is the primary purpose of the program. The bona fide employment relationships and personal service arrangements exceptions at 42 CFR sections 411.357(c) and (d), respectively, also may be applicable, depending on the circumstances.”
For a copy of the June 13, 2006, letter from Herb B. Kuhn, Director, CMS Center for Medicare Management, please click here.
For a copy of the October 1, 2004 letter from the ACCME to the Centers for Medicare and Medicaid Services, please click here.