AMA uses listening sessions to reemphasize opposition to VA’s National Standards of Practice
On Oct. 5, the AMA submitted written comments (PDF) to the Department of Veterans Affairs (VA) in response to a series of five Public Listening Sessions to inform the VA's effort to develop National Standards of Practice (NSPs) for 51 health care occupations.
Participants at the listening sessions, each of which was focused on a preset list of occupations, were asked to provide oral comments on state variances in the licensure requirements and their recommendations on what should be included in the NSP for a given occupation. Physicians’ main concern with the VA’s effort to develop NSPs has been that it may allow non-physician providers to deliver services and perform procedures independently that are outside the scope of their education, training and licensure.
The AMA participated in all five listening sessions and urged the VA to maintain the current standards of practice for certified-registered nurse anesthetists (CRNAs), optometrists, pharmacists, physician assistants, psychologists and other non-physician occupations. The AMA’s written comments, unconstrained by time, reemphasized and expanded on the oral comments with more evidence, data and contextual information to support the concerns regarding scope expansion. Find out more information about the VA’s effort to develop National Standards of Practice.
FDA releases proposed rule for regulation of laboratory developed tests
On Oct. 3, the Food and Drug Administration (FDA) released a highly anticipated proposed rule seeking stronger oversight of laboratory developed tests (LDTs). The rule proposes to phase out FDA’s current approach to exercise enforcement discretion with regard to LDTs over a period of four years, with limited exemptions. FDA cites serious concerns about safety and variability of test performance with a number of LDTs as justification for these changes and finds regulation under the Clinical Laboratory Improvement Amendments (CLIA) to be insufficient control for these issues. Should FDA finalize the proposal as written, most LDTs would be required to seek FDA approval or clearance prior to being offered to patients.
LDTs are defined as in vitro diagnostics that are developed and manufactured by a laboratory. FDA has exercised enforcement discretion with regards to LDTs in the past, not requiring them to be subject to FDA review and entrusting regulation of the laboratory space to CLIA. However, there has been a significant push over the last ten years to more strongly regulate the laboratory testing space, with this proposed rule coming after Congress failed to act on the issue.
The AMA has opposed past efforts to strongly regulate all LDTs, citing the impact on access to diagnostic testing services, impact on smaller laboratories in favor of large manufacturers and encroachment on scope of practice for pathology. The AMA will continue to review the proposed rule and work closely with pathology members of the Federation of Medicine to advocate for appropriate regulation that both ensures safety and performance of LDTs while maintaining access to diagnostic testing and the ability for pathologists to continue test design and development.
Action needed to address physician shortages within the Indian Health Service
The AMA is committed to identifying long-term strategies to mitigate the physician shortage within the Indian Health Service (IHS) and ensuring that American Indians, Alaska Natives and Native Hawaiians are provided with the health care that they need. The IHS is the only federal health system that does not have formal partnerships with academic medical centers, and this hurts their ability to recruit and retain physicians. As such, the AMA sent a letter (PDF) asking that the IHS establish an Office of Academic Affiliations responsible for coordinating partnerships with the Liaison Committee on Medical Education, the Commission on Osteopathic College Accreditation, accredited medical schools and residency programs accredited by the Accreditation Council for Graduate Medical Education. The AMA also encouraged IHS to develop funding streams to promote rotations and learning opportunities at IHS, Tribal, and Urban Indian Health Programs.
Furthermore, to enhance the physician workforce within the IHS, the AMA encouraged the IHS to evaluate existing regulatory and licensure opportunities and barriers that physicians face when seeking to provide health care services for American Indians, Alaska Natives, and Native Hawaiians. Working as a physician for a federally recognized AI/AN tribe, or a nonprofit Indian health care organization is a critically important job with the potential to positively impact the health of a historically marginalized and underserved population. However, physicians may need additional assistance understanding the regulations surrounding the licensure requirements for these positions. Accordingly, the AMA asked the IHS to help create resources to ensure that physicians can easily transition into a position caring for the AI/AN or Native Hawaiian communities.
More articles in this issue
- Oct. 6, 2023: Medicare Payment Reform Advocacy Update
- Oct. 6, 2023: State Advocacy Update
- Oct. 6, 2023: Advocacy Update other news
