In a comment letter (PDF) the AMA strongly opposed a proposed rule that seeks to significantly expand the number of immigrants who are denied permanent legal status on public charge grounds. The proposed rule would alter the definition of public charge from "primarily dependent" on the government for subsistence to any immigrant who receives "one or more public benefits."

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A significantly expanded list of factors to be considered in making a public charge determination, including the Children's Health Insurance Program (CHIP) and Supplemental Nutrition Assistance Program (SNAP), is coupled with the proposed change in definition. The AMA registered its concern that, if finalized, this proposal would lead to poorer health outcomes for the nation by discouraging immigrants from seeking necessary health care. The AMA letter also identified increases in poverty—as immigrants assume more out of pocket health care costs—and negative impacts to public health as foreseeable unintended consequences.

This strong stand against the proposed rule was the result of a clear directive from the AMA House of Delegates to oppose efforts that discourage immigrants from seeking health care.

The Trump administration released a new rule proposing changes to the Part D prescription drug benefit and Medicare Advantage programs. The proposed rule includes several potential policy changes impacting Part D protected class drugs, Part B drugs in Medicare Advantage and real-time pharmacy benefit tools at the point of care.

For Part D protected classes, the administration is proposing several changes that may adversely impact patient access to critical drug products. They are proposing to allow Part D plan sponsors to use prior authorization and step therapy protocols, as well as indication-based formulary design, for protected class drugs. Part D plan sponsors would also be able to exclude from their formularies any new formulations of protected class drugs, even if older formulations are no longer available, as well as drugs for which prices have increased beyond the rate of inflation.

Additionally, the administration is moving to formalize an earlier policy change that allows Medicare Advantage plans to use step therapy protocols for Part B drugs. The proposed rule reiterates this policy change, and provides some new parameters for Medicare Advantage plans using step therapy protocols. It would modify adjudication time periods for organization determinations and appeals, bringing them in line with Part D timeframes, and allow step therapy protocols only for new starts, not for existing treatment regimens. The AMA led a sign-on letter to the Centers for Medicare & Medicaid Services (CMS) opposing the earlier step therapy policy change and continues to have serious concerns about the increasing use of utilization management techniques by both public and private payers.

In addition to the protected class and step therapy proposals, CMS is proposing to require Part D plan sponsors to implement an electronic benefit tool to provide prescribers with access to real-time pharmacy benefit information for patients. The AMA has supported calls for this information to be available at the point of prescribing.

The Trump administration released a long-awaited report titled "Reforming America's Healthcare System Through Choice and Competition." The report aims to examine and discuss the influence of current state and federal policies on choice and competition in health care markets and makes recommendations to both state and federal lawmakers to "develop a better functioning health care market."

It discusses a significant number of topics, including scope of practice, telemedicine, graduate medical education funding, non-compete clauses in employment contracts, foreign-trained physicians, the Affordable Care Act, the system of third-party payment for health care services, health information technology and others. While the report is not open for public comment, the AMA will closely monitor policymakers at both the state and federal levels to see what, if any, actions are taken on the report's recommendations.

The U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) is seeking comments on a draft strategy regarding reducing regulatory and administrative burdens related to the use of electronic health records (EHR). The 21st Century Cures Act instructed HHS to identify, through consultation with stakeholders, ways to reduce regulatory and administrative burdens relating to EHR use.

The draft report outlines three overarching goals: reduce the effort and time required to record health information in EHRs; reduce the effort and time required to meet regulatory reporting requirements; and improve EHR functionality and ease of use. The AMA has advocated for reducing the burdens of health information technology and welcomes this opportunity to work with HHS to improve regulations around EHR use and design. ONC is seeking public feedback on the draft burden reduction strategy, and the AMA will be providing comments.

The AMA and 81 state medical and specialty societies signed on to a letter (PDF) urging CMS to exempt journal reprints and medical textbooks from Open Payments reporting using a preexisting statutory exclusion for "educational materials that directly benefit patients." The letter was drafted in response to a CMS request for feedback regarding the Open Payments reporting requirements. The letter also notes ongoing challenges with manufacturers reporting independent continuing medical education—this is not required unless the manufacturer requires, instructs, directs or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient—and it urges the agency to play a more proactive role in the reporting process by working with stakeholders on a common set of definitions of what is reportable.

Open Payments year-end reminder: Physicians who review their data and find potential errors can file disputes with the appropriate reporting entity (drug makers and Group Purchasing Organizations) through Dec. 31.

Learn more about reviewing and disputing public data.

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