By Andrew B. Roth, Jennifer McDaniel and Elise LeGros, Norton Rose Fulbright US LLP
As of July 1, 2021, each of the more than 800 medical schools, academic medical centers, teaching hospitals, and other institutions sponsoring residency and fellowship programs (Sponsoring Institutions) accredited by the Accreditation Council for Graduate Medical Education (ACGME) are required to follow updated ACGME Institutional Requirements – the ACGME rules and standards governing the organization and oversight of graduate medical education (GME) programs. The updated Institutional Requirements replace those that have been in effect since July 1, 2018.
Several of the changes to the Institutional Requirements bring them into conformity with the ACGME’s Common Program Requirements for Residencies and Common Program Requirements for Fellowships (the Common Program Requirements), which underwent “major changes” by the ACGME in 2018 and were further updated in 2020. Certain of the changes are broad in scope and applicability, dealing with mission-driven commitment of Sponsoring Institutions to GME. Significant examples of this include not only the requirement that Sponsoring Institutions accommodate residents/fellows with disabilities, consistent with their own institutional policies, but requirements reflecting a greater focus on diversity.
The ACGME, in 2018, set forth its expectation that Sponsoring Institutions have, and GME programs implement, policies and procedures related to the recruitment and retention of minorities underrepresented in medicine and medical leadership. The new Institutional Requirements now state that, in partnership with each of its residency and fellowship programs, the Sponsoring Institution must:
“engage in practices that focus on ongoing, mission-driven, systematic recruitment and retention of a diverse and inclusive workforce of residents/fellows, faculty members, senior administrative staff members and other relevant members of its GME community.”
The changes to the Institutional Requirements reflect greater attention by the ACGME, at the institutional level, to matters of inclusion. The Institutional Requirements, in alignment with the Common Program Requirements, now state that a Sponsoring Institution must ensure that its GME programs provide professional, equitable, respectful and civil environments free from unprofessional behavior.
In addition, Sponsoring Institutions must have policies and procedures (not necessarily GME specific) prohibiting discrimination in employment and in the learning and working environment. The new Institutional Requirements reinforce existing ACGME mandates governing program-level compliance with institution policies and procedures on employment and non-discrimination.
One employment / learning and working environment example: The Sponsoring Institution must provide clean and private facilities for lactation with proximity that is appropriate for safe patient care. Lactation locations must include clean and safe refrigeration storage for breast milk. This requirement codifies information currently found in the ACGME’s “Background and Intent” guidance in the Common Program Requirements.
The revised Institutional Requirements also reflect a focus on Sponsoring Institution Special Review procedures, modifying current requirements by requiring Sponsoring Institutions to have a Special Review protocol that establishes a “variety” of criteria for identifying underperformance, including “at a minimum, program accreditation statuses of Initial Accreditation with Warning, Continued Accreditation with Warning, and adverse accreditation statuses as described by ACGME policies [such as probation].” Sponsoring Institutions now will need to ensure that reports resulting from Special Reviews are issued timely, in addition to satisfying existing requirements that such reports include quality improvement goals, corrective actions and the process for monitoring outcomes by the Sponsoring Institution’s Graduate Medical Education Committee (GMEC).
The revised Institutional Requirements align the responsibilities of the Designated Institutional Official (DIO) with changes to the DIO’s duties and obligations that were first introduced via the Common Program Requirements. For example:
- The DIO must approve each Program Letter of Agreement – the agreement that governs the relationship between a Sponsoring Institution’s GME program and each of that program’s participating sites.
- The DIO must oversee the submission by the Sponsoring Institution and each of its GME programs of their respective “Annual Update” to the ACGME.
The revised Institutional Requirements include more focused changes as well, including:
- The Sponsoring Institution’s written statement pertaining to GME, reviewed and signed every five years, now must also include the Sponsoring Institution’s GME “mission” in addition to documentation of the institution’s commitment to GME.
- For Sponsoring Institutions with only one GME program, the GMEC now must include one of the program’s core faculty members other than the program director (if the program has core faculty members other than the program director).
- Consistent with the Common Program Requirements, the GMEC must review and approve exceptionally qualified candidates for resident/fellow appointments if the resident/fellow does not satisfy the Sponsoring Institution’s resident/fellow eligibility policy and/or the resident/fellow eligibility requirements in the Common Program Requirements.
- Following approval by the Sponsoring Institution’s GMEC, the DIO must oversee applications for accreditation and recognition, requests for voluntary withdrawal of accreditation and recognition, and requests for changes in residency and fellowship program complements.
- The Sponsoring Institution must be able to “demonstrate adherence to all institutional graduate medical education policies and procedures.”
- Sponsoring Institutions must ensure that residents are provided with documentation of the details of professional liability coverage, before the start date of resident/fellow appointments and must provide “written advance notice of any substantial change to the details of their professional liability coverage.”
Finally, Sponsoring Institutions preparing for their first ACGME institutional “Self-Study” in connection with the 10-year ACGME site visit, will notice that the updated Institutional Requirements now include the requirement that Institutions complete a Self-Study prior to the 10-year accreditation site visit.
The revised Institutional Requirements and ACGME guidance on conducting Self-Studies are each available on the ACGME’s website (www.acgme.org).
Andrew Roth is a transactional and regulatory attorney for clients throughout the healthcare, life sciences and education industries, with more than 30 years of experience representing universities, academic medical centers, health systems, hospitals, correctional health providers, long-term care institutions, physicians and other life sciences and health care providers, private equity investors, insurance companies and managed care organizations. Andy’s transactional experience includes mergers and acquisitions, joint ventures and other collaborative affiliations, most recently serving as lead counsel in the $3.75 billion sale of the health insurance business of a major New York HMO to the largest provider of government-sponsored health insurance in the country. On the regulatory side, Andy counsels clients in the areas of corporate compliance and corporate governance, digital health, clinically integrated networks and population health management, fraud and abuse, HIPAA, clinical research, medical staff matters, Medicare/Medicaid and the accreditation of residency and fellowship programs in teaching hospitals throughout the country.
Jennifer McDaniel has broad healthcare transactions, regulatory and operational experience. Jennifer maintains a particular focus on graduate medical education (GME) matters, assisting institutions and GME programs through the Accreditation Council on Gradudate Medical Education (ACGME) accreditation and site visit process, including by conducting GME policy reviews and audits and counseling clients on compliance with ACGME Requirements. In addition to GME matters, Jennifer regularly assists health care clients with state licensing and state and federal enrollment and reimbursement matters. She has experience with state contracting issues, in both the health care and child welfare areas.
Elise LeGros focuses on a broad range of healthcare transaction and regulatory matters. Elise has experience working on various types of transactions in the healthcare industry, including health system and hospital mergers and acquisitions, corporate reorganizations, and joint ventures. She also assists clients with drafting and negotiating physician-hospital agreements, including recruitment, employment, professional services, and co-management. Elise advises clients on a broad range of healthcare regulatory matters, including compliance with the Stark Law, Anti-Kickback Statute, and Civil Monetary Penalties statute. She is regularly involved in the health regulatory compliance due diligence associated with transactions. She also has experience in addressing the regulatory implications of healthcare entity changes of ownership.