Oct. 4, 2019: National Advocacy Update

The AMA and six other organizations have asked (PDF) two congressional committees to use their oversight of the 21st Century Cures Act to improve interoperability and empower patients with meaningful health information while ensuring data is safe and secure. The letter arrives as the administration is drawing up its plans to implement the law and adopt information blocking rules. The AMA appreciates several of the administration's proposals, particularly related to electronic health record (EHR) certification, EHR application programming interfaces (API), and modifying EHR vendor business practices and behaviors.

The AMA is, however, expressing concern with the overall complexity of the proposed rules. Rather than supporting the goals Congress outlined in the Cures Act, many of the administration's proposals will dramatically affect patient privacy and safety as well as data security. The AMA has also advised that proposals will add to physician burden and burnout. The letter recommends four specific actions the administration should take to improve its rule:

• Additional rulemaking prior to finalization: To ensure a sufficient level of industry review and to appropriately respond to stakeholder feedback, the Office of the National Coordinator for Health IT (ONC) should issue a supplemental rulemaking to address outstanding questions and concerns.
• Enhanced privacy and security: The proposed rule does not sufficiently address Cures' directives to protect patient data privacy and ensure health IT security. Further, it is imperative that the Committee continue its oversight of privacy and security issues that fall outside of the Health Insurance Portability and Accountability Act (HIPAA) regulatory framework.
• Appropriate implementation timelines: ONC should establish reasonable timelines for any new EHR requirements. Physicians must be given sufficient time to deploy and test these systems, which must take into account competing regulatory mandates.
• Revised enforcement: The U.S. Department of Health and Human Services (HHS) should use discretion in its initial enforcement of the data blocking provisions of the regulation, prioritizing education and corrective action plans over monetary penalties.

The AMA will continue to engage with Congress and the administration to implement these needed changes. The final rule is expected later this year or early in 2020.

The AMA recently wrote (PDF) to the Substance Abuse and Mental Health Services Administration (SAMHSA) to oppose a proposed rule that would expand the circumstances in which a court could authorize disclosure of a patient's substance use disorder (SUD) records under 42 CFR Part 2. The proposal would permit a court to authorize disclosure of a patient's confidential communications when the disclosure is necessary in connection with investigation or prosecution of an extremely serious crime, even if the extremely serious crime was not allegedly committed by the patient.

SAMHSA believes the change would help crack down on "rogue doctors and pill mills that have contributed to the opioid crisis," but it does not provide any evidence for this claim. The AMA stated in its comments that the change is contrary to the purpose of the underlying Part 2 law and would expose the confidential communications of hundreds of thousands of individuals, including those seeking treatment for alcohol—not drug—use. The AMA urged SAMHSA to withdraw its proposal.

On Sept. 19, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) introduced H.R. 3, the Lower Drug Costs Now Act of 2019, along with Ways and Means Committee Chairman Richard E. Neal (D-MA) and Education and Labor Committee Chairman Bobby Scott (D-VA).

This legislation, largely spearheaded by House Speaker Nancy Pelosi (D-CA), would give HHS the power to negotiate prices for prescription drugs without generic or biosimilar competition. Negotiated prices would be available to all payers, including the commercial market. The maximum negotiated price would be set at no more than 120 percent of an international price index, called the "Average International Market" price. The bill would also create a $2,000 out-of-pocket spending cap for Medicare beneficiaries.

The House Energy and Commerce, Ways and Means, and Education and Labor Committees are expected to mark up this legislation, followed by a vote before the full House, in late October. The legislation is expected to pass the House along party lines with opposition from House Republicans.

On Sept. 24, the AMA sent a letter (PDF) regarding H.R. 3 to the chairs of the aforementioned committees expressing appreciation for the efforts to address the high cost of prescription medications.

Price increases for brand pharmaceuticals and biologicals continue to outpace the rate of inflation, limiting affordability and access for our patients. Furthermore, higher prices lead to insurers using increasingly onerous utilization management programs that erect additional barriers to access, raise patient out-of-pocket costs, and add administrative hurdles for both patients and already-stressed physician practices.

The AMA's letter urges Congress to pass meaningful legislation this year to ensure that patients have access to affordable medications.

In a joint statement, the AMA pledged to support the efforts of the President's Roadmap to Empower Veterans and End a National Tragedy of Suicide (PREVENTS) Task Force. This cabinet-level task force is charged with bringing together federal, state and local governments, along with non-governmental organizations and the veteran community to create a broad-based national public health effort to prevent veteran suicide.

The AMA's support for PREVENTS follows the participation of AMA board members Bobby Mukkamala, MD, and Jesse M. Ehrenfeld, MD, MPH, in White House meetings regarding how best to combat the epidemic of veteran suicides.

Medicare's alternative payment models (APM) for primary care practices are works in progress, with the recently announced Primary Cares initiative coming in response to physician-developed proposals. A new analysis takes a point-by-point approach to explain what physicians should know about it in comparison with Medicare's current APM demonstration project.

Primary Cares, shaped with substantial physician input, was unveiled in April by HHS Secretary Alex Azar at the AMA's Washington office.

"Providing adequate financial support for high quality primary care must be an essential element of any strategy to improve the quality and affordability of our country's health care system," Gerald E. Harmon, MD, said at the time. Dr. Harmon is a family physician and a member of the AMA Board of Trustees.

The initiative introduces Primary Care First (PCF), a streamlined, potentially higher-paying APM that provides an alternative to the current five-year demonstration project, Comprehensive Primary Care Plus (CPC+) that was launched in 2017.

PCF is scheduled to be available in January 2020, and ultimately will be offered in 26 states and metropolitan regions, eight more than CPC+. Practices in CPC+ regions will have to wait a year before they can apply for PCF. Primary Cares also creates a direct contracting option, but the qualification threshold—at least 5,000 Medicare patients—places it out of reach for solo and small practices.

The AMA's analysis, Medicare Alternative Payment Models for Primary Care (PDF), is one in a set of AMA resources that provide detailed, physician-focused insights on Medicare APMs and the APM-enabling Medicare Access and CHIP Reauthorization Act.

Read the full story here.

• Oct. 4, 2019: Advocacy spotlight on Highlights of CMS' 2020 physician fee schedule and QPP proposed rule 
• Oct. 4, 2019: State Advocacy Update 
• Oct. 4, 2019: Judicial Advocacy Update