Advocacy Update

Nov. 29, 2018: National Advocacy Update


The Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 (PDF) calls for the Health and Human Services Department secretary, acting through the Assistant Secretary for Planning and Evaluation (ASPE), to conduct a study evaluating the effect of individuals' socioeconomic status (SES) on quality measures and measures of resource use under the Medicare program.

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The first component of the statute required a 2016 Report to Congress (PDF). For the second report, which will expand upon the first and will be released in late 2019, ASPE is looking at the interaction of medical and social risk Medicare datasets to quantify socioeconomic status. As a result, ASPE recently released a request for information to inform the second report.

The AMA's comments (PDF) focus on rural and underserved patient populations. More specifically:

  • The need for education on how to collect and document social risk factors and social determinants of health including access to resources to address such factors in a manner that respects a patient's autonomy and privacy and do not lead to increased physician administrative burden
  • Legal restrictions that may limit a physician's ability to successfully implement these practices
  • The ability for physicians to receive financial incentives or other reimbursement methods to offset these costs
  • Standardization of social determinants of health data elements to enable reliable and consistent tracking of progress, integration into electronic health records and registries, and for aggregation of the information for secondary uses such as measurement

The AMA submitted comments (PDF) on Nov. 26 to the Food and Drug Administration (FDA) in support of revised draft guidance (PDF) the agency issued on drug compounding. The revised draft guidance "Insanitary Conditions in Compounding Facilities" updates previous guidance under the same name that would have regulated physician offices as compounding pharmacies if those offices were engaged in sterile drug preparation.

Under the previous guidance, physicians preparing drug products such as allergy injections, buffered lidocaine and others would have been subject to the same environmental and engineering control requirements as pharmacies compounding sterile drug products. As most physician offices would be unable to meet these requirements, the AMA worked closely with FDA to push for changes before the guidance was finalized. Earlier this summer, FDA re-released the guidance as a revised draft that no longer included physician offices in the definition of compounding facility. The revised draft also noted that the FDA does not intend to take enforcement action against physician offices who are preparing sterile drug products for administration to their patients within the office setting.

While the proposed FDA revisions would be a win for the physician community, physicians are still facing challenges with the work of the United States Pharmacopoeia (USP) to revise their Chapter 797 standards for sterile compounding. As many states adopt the requirements of USP Chapter 797 as official standards, it is critical that those standards do not subject physicians to overly burdensome environmental and engineering requirements.

The AMA continues to work closely with impacted physician specialty organizations and USP to ensure the final updated Chapter 797 accommodates physicians engaging in the appropriate preparation of sterile drug products for administration to patients.