Dec. 15, 2023: National Advocacy Update

As a reminder, registration is open for the 2024 AMA National Advocacy Conference, Feb. 12-14 at the Grand Hyatt in Washington, D.C.  

The AMA National Advocacy Conference brings the power of organized medicine to our nation’s capital. Don’t miss your chance to: 

• Connect with industry experts, members of Congress and the administration, and others about federal efforts to improve health care 
• Advocate on crucial health care issues affecting physicians and patients 

Featured speakers will include: 

• Donna Brazile, renowned political strategist and commentator, former interim chair of the Democratic National Committee 
• Ana Navarro, GOP strategist, political contributor to CNN and Telemundo, and co-host of ABC’s The View 
• Geoff Bennett, PBS NewsHour co-anchor   
• Brian Miller, MD, MBA, MPH, practicing hospitalist at the Johns Hopkins Hospital, assistant professor of medicine at the Johns Hopkins University School of Medicine, and nonresident fellow at the American Enterprise Institute 

For more information, view the preliminary meeting agenda (PDF). 

On Dec. 13, the Office of the National Coordinator for Health Information Technology (ONC) published the Health Data, Technology, and Interoperability (HTI-1) Final Rule. The rule continues implementation of the 21st Century Cures Act as well as updates the ONC Health IT Certification Program while advancing interoperability, improving transparency, and supporting the access, exchange and use of electronic health information. 

In the rule, ONC established new transparency requirements for augmented intelligence (AI) and other predictive algorithms that are part of the certified health IT program. The new decision support interventions (DSI) criterion ensures that Health IT Modules enable the transparent use of predictive models and algorithms to aid decision making in health care. These changes are intended to improve trustworthiness and support consistency around the use of health care predictive algorithms or models.  

The final rule also discontinues year-themed editions for health IT certification criteria and renames all certification criteria within the Program simply as “ONC Certification Criteria for Health IT.” This single set of certification criteria would be updated in an incremental fashion in closer alignment to standards development cycles and regular health IT development timelines.  

In addition, ONC adopted United States Core Data for Interoperability (USCDI) Version 3 as the new baseline data set that is intended to improve the standardization of health information that is accessed, exchanged and used within certified health IT. Version 3 will coexist with Version 1 in the standard until Version 1 expires on Jan. 1, 2026—it includes several additional data elements on patient demographics (such as sexual orientation and gender identity) and social determinants of health (SDOH). Expanding the data elements and data classes included in USCDI by moving to Version 3 increases the amount of data available to be used and exchanged for patient care.  

Moreover, the rule enhanced the electronic health record (EHR) Reporting Program through the “Insights Condition.” This new Conditions and Maintenance of Certification requirement expects developers of certified health IT to provide transparency into the use and benefits of their certified health IT, with an initial focus on interoperability.

Without adoption of policies and procedures to require compliance with mental health and substance use disorder parity laws for Medicaid and CHIP enrollees, payers will continue to inappropriately restrict and deny access to care, the AMA wrote (PDF) to the Centers for Medicare & Medicaid Services (CMS). 

The AMA made several specific recommendations to CMS, including: 

• Ensuring that the most recent amendments and enforcement mechanisms in the federal Mental Health Parity and Addiction Equity Act apply directly to both Medicaid and CHIP.
• Agreeing with CMS’ proposals to identify potential parity violations through comparisons of different measures and data points.  
• Comparing rates of coverage being denied for mental health and substance use disorder (MH/SUD) benefits compared to rates of coverage being denied for medical and surgical benefits.
• Reviewing average and median appointment wait times for MH/SUD providers compared to medical and surgical providers. 
• Requiring health plans and issuers to disclose what information they use to determine divergences from professional medical association patient placement criteria and national practice guidelines.
• Prohibiting plans and issuers from continuing the use of prior authorization and other non-quantitative treatment limitations (NQTLs) for MH/SUD services if the plan or issuer cannot provide the documentation and other information to demonstrate that the NQTL is compliant with MHPAEA.
• Barring a plan or issuer from re-instituting the NQTL until it has put a corrective action plan into place.
• Levying significant monetary penalties upon a plan or issuer for the duration of time between a finding of insufficiency or non-compliance and the time it takes for the corrective action plan to be put into effect.

The AMA emphasized how “When health plans devise their own varying standards, the inevitable result is to force physicians to justify their reasoning for providing broadly accepted, evidence-based standards of care—typically so the health plan can delay treatment and possibly avoid payment. This pernicious use of NQTLs to delay and deny care is devastating to patients’ health and well-being—as well as to physician practices.”

The inevitable result is that “Over time, this continued and constant exposure to these barriers, and the ongoing negative impact on the patients they have been trusted to care for is extremely demoralizing and draining to physicians. This problem is particularly acute for referring and authorizing care for mental health issues and substance use disorders.”

Read the full letter (PDF).

On Dec. 12, the Department of Health and Human Services (HHS) celebrated the designation of five organizations as qualified health information networks (QHINs) under the Trusted Exchange Framework and Common Agreement (TEFCA) in a signing ceremony. Leaders from eHealth Exchange, Epic Nexus, Health Gorilla, KONZA and MedAllies each signed the common agreement and will begin operating to support data exchange through TEFCA.   

Additional QHINs will be onboarded in the near future, and TEFCA will also soon be circulating the Common Agreement Version 2.0, which is expected to include enhancements and updates to require support for Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) based transactions. 

Passed into law through the 21st Century Cures Act, TEFCA is a private-public effort to connect the nation’s health care providers, payers and patients and enable more seamless interoperability. TEFCA outlines a common set of principles, terms and conditions to support the nationwide exchange of electronic health information. Participation in TEFCA is voluntary, but it provides another means for health system participants to exchange patient data even without access to a state-based or electronic health record (EHR)-specific health information exchange. More information on TEFCA is available through the Sequoia Project, which serves as the Recognized Coordinating Entity in charge of overseeing the TEFCA Network. 

On Dec. 4, the AMA submitted comments on the Food and Drug Administration’s (FDA) proposed rule to regulate Laboratory Developed Tests (LDTs). In the proposed rule, FDA is seeking to end the enforcement discretion approach it has applied to LDT oversight for decades, potentially upending the laboratory industry. The FDA is proposing to phase out the enforcement discretion approach over a period of four years, with the vast majority of LDTs potentially required to seek FDA review and approval.  

The AMA has joined the laboratory community in expressing serious concerns over the impact the proposed rule will have on access to laboratory testing. It is expected that there could be serious impacts on the ability of laboratories to continue offering their full testing menu. It is also expected that, if finalized, a contraction in the market resulting from new regulatory requirements would result in both delays in care as laboratories would be forced to send specimens to outside laboratories and increases in the costs of diagnostic testing—both untenable situations for patients.  

The AMA has asked FDA to pause prior to finalization of any proposed rule to work more closely with stakeholders to develop a regulatory approach more appropriate and tailored to LDTs and the needs of the diagnostics community. However, FDA has already cast aside calls from the AMA and many others to extend the comment period on the proposed rule and has signaled that they are fast-tracking towards finalizing the rule in April 2024. Should FDA finalize this controversial proposal, it is expected that many laboratory and diagnostic testing entities will pursue legal action against the agency. 

At the 28th meeting of the Conference of the Parties (COP) to the United Nations Framework Convention on Climate Change (COP28), HHS announced a Climate Change and Health Equity Strategy Supplement that highlights the work across the Department to support climate resilience and greenhouse gas emission reduction in the U.S. health sector. 

The Strategy Supplement describes the HHS agency accomplishments and planned actions to help public health, health care, and human services stakeholders better address climate-related risks and reduce greenhouse gas emissions. Research programs, forecasting tools, and technical assistance supports for communities and health care providers are among the 50 planned actions across HHS.  

In 2021, HHS published its Climate Action Plan (PDF) and committed to supporting the development of a climate resilient and low-carbon health sector through a series of initiatives and resources to protect the health of people living in the U.S. from climate change. 

With the impending shortage of physicians and nurses threatening to undermine patient access to care, the New Democrat Coalition (NDC), a collection of 98 center-left Democrats in the House of Representatives committed to fostering a climate of positive economic growth for all Americans, invited the AMA and other key health care stakeholders to participate in a Dec. 6 roundtable discussion on health care workforce issues. The roundtable was co-led by Representatives Kathy Manning (D-NC), chair, NDC’s Workforce Development Task Force, and Terri Sewell (D-AL), chair, NDC’s Health Care Task Force. Representatives Jimmy Panetta (D-CA) and Brittany Pettersen, vice chair of the NDC Health Care Task Force, also joined the discussion.

Roundtable participants included:

• Chris Sherin, assistant director, Division of Congressional Affairs, American Medical Association (AMA)
• Danielle Turnipseed, chief public policy officer, Association of American Medical Colleges (AAMC)
• Paloma Hernandez, chair of the National Association of Community Health Centers (NACHC) Board of Directors; CEO of Urban Health Plan
• Martha Dawson, immediate past president, National Black Nurses Association (NBNA)
• Michael Belmonte, MD, Darney-Landy fellow, American College of Obstetricians and Gynecologists (ACOG)
• Katie Boston-Leary, director of nursing programs, American Nurses Association (ANA)

The AMA’s comments initially focused on outlining the dire circumstances of the physician shortage. In fact, there is a projected shortage of between 54,100 and 139,000 physicians by 2033. This figure also reflects a projected shortage of between 21,400 and 55,200 primary care doctors and between 33,700 and 86,700 specialists. To tackle this problem, the AMA highlighted a series of bills that fall into two broader categories of solutions: 1) increasing the pipeline of physicians; and 2) creating an environment that retains as much of the current population of practicing physicians as possible.

To increase the pipeline of future physicians, Congress should:

• Eliminate the current limit on Medicare supported residency slots created following the enactment of the Balanced Budget Act of 1997
• Enact H.R. 2389/S. 1302, the Resident Physician Shortage Reduction Act
• Pass more student loan relief
• Advance targeted immigration reforms including H.R. 4942/S. 665, the Conrad State 30 and Physician Access Reauthorization Act, and H.R. 6205/S. 3211, the Healthcare Workforce Resilience Act

To help improve workforce conditions for existing physicians, the AMA encouraged the New Democrats to concentrate on enacting prior authorization reforms and wholescale changes to the Medicare payment system. In particular, coalition members were urged to support the Improving Seniors’ Timely Access to Care Act and H.R. 4968, the GOLD CARD Act, as ways to reduce the burden of utilization management policies. Finally, coalition members were urged to cosponsor H.R. 2474, the Strengthening Medicare for Patients and Providers Act, and H.R. 6683, the Preserving Seniors’ Access to Physicians Act.

AMA greatly appreciates the New Democrat Coalition’s interest in health care workforce issues and looks forward to working with this caucus to advance these important legislative solutions during the 118th Congress.

In a recent letter (PDF) to the U.S. Census Bureau, the AMA requested an extension of the comment period, thus delaying a decision, on the proposed content related to disability for the 2025 American Community Survey (ACS) and the Puerto Rico Community Survey (PRCS).

The AMA is concerned about the lack of information that has been provided about the extent to which the disability community has had the opportunity to provide their input in the development of the proposed changes and expressed the importance of including people with disabilities in the decision-making process. For these reasons, the AMA recommends:

1. Delaying a decision on changes to the disability questions
2. Developing and implementing a replicable inclusion plan for comprehensive input from the disability community and key interested parties

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