Feb. 9, 2018: National Advocacy Update

Policymakers should not limit their focus to reducing the supply of opioids, said AMA Trustee Patrice A. Harris, MD, MA, during her Jan. 30 testimony at a Food and Drug Administration (FDA) public meeting. At the meeting, entitled "Opioid Policy Steering Committee: Prescribing Intervention—Exploring a Strategy for Implementation," the FDA sought stakeholder input on several ideas for improving the safe use of opioid analgesics and curbing overprescribing to decrease the occurrence of new addictions as well as drug diversion.

"Our focus cannot be limited to just reducing the supply of opioids." Dr. Harris said. "We must also improve care for patients with pain, which means we have to make sure there is access to non-opioid, non-pharmacologic options for pain." American Academy of Pain Medicine President Steven Santos expressed a similar view, and voiced concern that arbitrary dose thresholds may contribute to stigmatization of pain management with opioids.

Dr. Harris also focused on the need to reduce barriers to electronic prescribing of controlled substances (EPCS) and to better integrate EPCS, electronic health records (EHRs), and prescription drug monitoring programs into physicians' practice workflows—a theme that was echoed by several other participants.

The Centers for Medicare and Medicaid Services (CMS) again updated its extreme and uncontrollable circumstances policy. Merit-based Incentive Payment System (MIPS)-eligible clinicians in Federal Emergency Management Agency-designated areas affected by Northern California wildfires and hurricanes Harvey, Irma, Maria and Nate will be automatically identified. Eligible clinicians in these identified areas will be exempt from MIPS scoring for 2017. They do not have to take any action.

If, however, an eligible clinician is in one of the designated areas and chooses to participate in MIPS—as either an individual or group—they must submit data on two or more MIPS performance categories. They will then be scored on those performance categories. The AMA had urged CMS to create this policy and is grateful that the agency has continued to update it as events develop.

In response to an FDA request for recommendations on how to relieve regulatory burdens, the AMA urged the agency to change its proposals for regulating drug-preparation activities in physician offices and for collection of the Unique Device Identifier (UDI).

The AMA, in a Feb. 5 letter (PDF), called for new policy proposals concerning the oversight of physician offices that prepare sterile drug products for administration to patients. The current FDA proposal calls for physician offices that prepare any sterile drug products to meet the same equipment and facility requirements as pharmacies, something not tenable for physician practices. The AMA maintains that preparation of sterile drug products for administration to patients at the point of care is not a drug-compounding activity and called for the FDA to exempt these activities from the proposed requirements.

The FDA has indicated a willingness to find a new path forward for physician offices. Its recently released Compounding Policy Priorities Plan acknowledges that physician activities in many cases pose negligible risks to patients and should therefore not be subject to the same compliance policy as compounding pharmacies. Physicians can expect the FDA to issue new guidance to this effect sometime this year. The AMA also provided comments on this issue to the Federation of State Medical Boards, which will be considering new policy on physician compounding at its House of Delegates' annual meeting April 28 in Charlotte, N.C.

In addition, the AMA recommended the FDA reconsider its stance on the capture of the UDI on administrative claims forms. While strongly supportive of implementing the UDI system, the AMA favors capture of the full UDI in a patient's electronic health record and in registries, as opposed to on the claim form. Claims information does not necessarily follow patients throughout their lives and would not capture complete product information from the UDI. Consequently, the AMA recommended that patient safety would be better served by capture in these other locations.

Holding a public meeting on digital health innovation served as the first step taken by the FDA toward a proposed new oversight structure for software functioning as a medical device. AMA Vice President of Healthcare Quality Kathleen Blake, MD, attended the Jan. 30-31 meeting and participated in a panel discussion with health care stakeholders.

The FDA has proposed a new regulatory structure for the oversight of software as a medical device, as there are serious questions as to whether the current review system would be able to accommodate the rapid pace of development and change in the software industry. The FDA is proposing a streamlined system of review that would begin with "pre-certification" of software developers meeting certain quality and safety standards.

Dr. Blake provided the physician perspective on this new proposal, raising questions about how the indication system would work and about the importance of post-market surveillance. The FDA "pre-cert" program is currently in a pilot stage, with more details to be released as the agency works towards finalization at the end of the year.

The White House Office of American Innovation (OAI) held a small meeting on EHR interoperability last week. Among the senior administration officials who attended were OAI leader Jared Kushner, CMS Administrator Seema Verma and National Coordinator for Health Information Technology Donald Rucker, MD.

Representing the AMA was Trustee Jesse Ehrenfeld, MD, MPH, who emphasized the critical need to improve the movement of data in and out of EHRs. Dr. Ehrenfeld outlined two ways to improve interoperability: Prioritize specific clinical or business use cases and remove the federal requirements that are driving problematic EHR design. The administration expressed a strong commitment to make headway on this critical topic.

• Feb. 9, 2018: Advocacy spotlight on Congress approves fifth spending bill
• Feb. 9, 2018: State Advocacy Update