Progress made on two of CMA’s priorities for regulatory relief

February 05, 2018
Area(s) of Interest: Advocacy Electronic Health Records Health Information Technology 

California physicians are overwhelmed with unnecessary, burdensome regulations that take time and resources away from providing quality patient care. Over the past year, the California Medical Association (CMA) has been aggressively advocating for a reduction in the regulatory burdens under the Medicare and Medicaid programs.

In the past month, there has been notable progress in two of CMA’s top 10 priorities for regulatory relief:

  • #2: Enforce electronic health record (EHR) vendor compliance and interoperability

  • #9: Exempt physician in-office drug compounding from new U.S. Food and Drug Administration (FDA) rules

ONC releases a framework for interoperability

The Office of the National Coordinator for Health Information Technology (ONC), which oversees health information technology for the federal government, recently released a plan to improve the exchange of clinical data between hospitals, clinics, physicians and patients. This draft "Trust Framework"" lays out a set of principles, terms and conditions to better enable the trusted sharing of information. 

The Trust Framework is designed to bridge the gap between physicians' and patients' information systems and enable all types of health care stakeholders and health information networks (HINs) to share patient data. Central to this would be the ability for physicians to query all or some of their patients' health information regardless of where it is stored. Additionally, because HINs would be required to create similar interfaces, the Trust Framework would also help decrease the cost and burden of connecting and exchanging data between electronic health records.

CMA and the American Medical Association (AMA) have been advocating for the federal government to mandate, enforce and push EHR interoperability. This is a promising on-ramp for promoting the open exchange of information.

ONC is also hosting a webinar on the Draft Trusted Exchange Framework on February 15, 2018, from 10:30-11:30 a.m., P.T.

FDA reacts to physician concerns on compounding issues

The FDA recently released its 2018 Compounding Policy Priorities Plan. Within the plan, the FDA notes that it has heard the concerns raised by the physician community in response to its proposed guidance on Insanitary Conditions in Compounding Facilities. That guidance, initially released in 2016, proposed to require all entities engaged in sterile drug manipulations (including physician offices) to meet a number of onerous requirements, including the requirement for sterile drug preparations to take place in ISO class 5 clean rooms.

Over the past year, CMA and AMA have outlined the significant concerns of the physician community over this proposal and its potential to severely affect patient access to critical treatments. In response, the 2018 Compounding Policy Priorities Plan states that the FDA plans to release new draft guidance that will address these concerns, recognizing that some providers prepare small quantities of sterile drugs for administration to their patients that do not proposed a heightened risk to patients and should not be subject to the same compliance policy as other compounding entities. This signals a significant departure from the agency's earlier thinking and CMA is cautiously optimistic that any new guidance will be a step in the right direction toward maintaining access to critical treatments for patients. The agency did not provide a specific timeline for release of this draft guidance.


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