June 28, 2024: National Advocacy Update

The Departments of Health and Human Services, Labor and the Treasury announced a 120-day exception period for disputing parties impacted by the recent Change Healthcare cybersecurity incident to initiate open negotiation for impacted items or services as part of the Independent Dispute Resolution Process under the No Surprises Act.

The announcement comes in response to numerous reports from providers, facilities and providers of air ambulance services that they are unable to initiate open negotiation because they have not received necessary payment information or disclosures from plans or issuers due to disruptions to claims processing resulting from the Change Healthcare cybersecurity incident. The exception applies to any item or service furnished on or after Jan. 1, 2024 and ends Oct. 12, 2024. To claim the exception, providers and facilities must furnish this attestation statement (PDF) to plans or issuers alongside the standard open negotiation initiation form. Questions may be directed to [email protected]. 

The Centers for Medicare & Medicaid Services (CMS) will phase out the Accelerated and Advance Payment (AAP) Program that was included as part of the Change Healthcare/Optum Payment Disruption (CHOPD) effort at the agency on July 12. CMS launched AAP in early March to help reduce cash flow disruptions that were experienced by some Medicare physicians, hospitals and pharmacists when Change Healthcare turned off its systems on Feb. 21 upon news of the cyberattack.  

CMS distributed 4,722 CHOPD advance payments to Medicare Part B suppliers, including physicians, non-physician practitioners and durable medical equipment suppliers, totaling more than $717.18 million. The CHOPD also issued accelerated payments to over 4,200 Medicare Part A providers, such as hospitals, totaling more than $2.55 billion.  

The AMA is hearing from some physician practices that are still struggling in the wake of the Change Healthcare cyberattack. With the ending of the CMS program, practices in need of advance payments can reach out directly to Change Healthcare/UnitedHealth Group as its Temporary Funding Program remains active. More information and further details on AMA’s actions in support of physicians related to the cyberattack are available on the AMA website. 

CMS recently released a final rule (PDF) that will significantly improve prescription drug benefit transparency in the Part D program. Effective Jan. 1, 2027, Part D drug plans must implement the National Council for Prescription Drug Programs (NCPDP) Real-Time Prescription Benefit (RTPB) standard. RTPB technology allows physicians to access critical data regarding a specific patient’s prescription drug coverage, including prior authorization and step therapy requirements, patient cost-sharing and clinically appropriate alternative medications covered by the plan, at the point of prescribing in the electronic health record (EHR).  

This new rule substantially advances transparency of drug coverage and out-of-pocket costs, as existing CMS regulations only require Part D plans to implement a single real-time benefit tool that integrates with one EHR—leading to serious limitations in data access and interoperability. Requiring use of the NCPDP RTPB standard will support widespread implementation of this key transparency tool across EHR vendors and enable physicians to engage in informed discussions about drug selection with their patients at the time of prescribing. Notably, the final regulation aligns with the AMA’s comments (PDF) on CMS’ proposed rule, as well as new policy adopted at the 2024 AMA House of Delegates meeting.  

The rule also requires implementation of updated versions of the NCPDP Formulary and Benefit (F&B) and SCRIPT electronic prescribing and standards effective at the beginning of 2027 and 2028, respectively. These changes will improve the electronic prescribing and F&B functionalities in physicians’ EHRs. 

On June 13, the House Education and Workforce Committee marked up and passed by a vote of 36-0, H.R. 618, the Improving Access to Workers’ Compensation for Injured Federal Workers Act introduced by Reps. Walberg (R-MI) and Courtney (D-CT).   

The AMA has opposed this legislation the past few Congresses and worked to prevent the bill from gaining traction in the Senate after it had passed the House in the 117th Congress by a vote of 325-83. The bill would amend the Federal Employees Compensation Act (FECA) to allow nurse practitioners and physician assistants to diagnose, prescribe, treat, and certify an injury and extent of disability for purposes of compensating federal workers under FECA. Current law prohibits non-physician providers (NPP) from making determinations of federal worker injuries under FECA and reserves this function to physicians who have the necessary education, training and expertise to make these evaluations. H.R. 618 would remove physicians from the care team and allow PAs and NP to make these federal workers’  compensation determinations under the guise of expanding access to these determinations for rural and underserved areas of the country experiencing a shortage of physicians.  

Proponents of this legislation argue there are long wait times, leaving patients frustrated and without timely determinations, and that many of the regions in their districts lack physicians. They claim that PAs and NPs would fill this void, allowing workers to receive timely workers’ compensation determinations and return to the workforce more quickly.   

The AMA issued a letter of opposition (PDF) shared with House Leadership and Committee Members prior to the markup. The AMA remains steadfast in its commitment to patients who have said repeatedly that they want and expect physicians to lead their health care team. However, H.R. 618 effectively removes physicians from the care team and would set up federal workers for suboptimal health outcomes and increased costs, without improving access to care. By providing injured federal workers with access to health care professionals who possess a lower level of training, there is a risk that they would not receive the right care at the right time, incur greater health care costs and worse outcomes, and remain injured and out of the workforce longer. The AMA letter also debunks the misconception (PDF) that PAs and NPs practice where physicians are not present, citing studies showing that they tend to all practice in the same areas of the state, including in states where NPPs can practice independently.   

The AMA will continue to work with the medical specialty societies to advocate against this legislation in Congress and ensure that the bill does not gain traction in the Senate should it pass the House again this year.  

The U.S. Department of Health and Human Services (HHS) has finalized a rule establishing disincentives (PDF) for health care providers that engage in information blocking. This final rule exercises the Secretary’s authority under the 21st Century Cures Act to establish “disincentives” for health care providers who engage in practices that the health care provider knew were unreasonable and were likely to interfere with, prevent or materially discourage the access, exchange or use of electronic health information, except as required by law or covered by a regulatory exception. Disincentives include penalties under the Centers for Medicare & Medicaid Services (CMS) programs and potential exclusion from the Medicare Shared Savings Program (MSSP).  

This rule impacts certain providers, including: 

• Eligible hospitals or critical access hospitals (CAH): Eligible hospitals or CAHs identified by HHS’ Office of Inspector General (OIG) as information blockers will not be considered a meaningful EHR user. EHR use is a prerequisite for success in several CMS programs. Eligible hospitals would lose three quarters of the annual market basket increase, and CAHs would receive payments of 100% instead of 101% of reasonable costs. 
• Merit-based Incentive Payment System (MIPS) Promoting Interoperability (PI): MIPS-eligible clinicians identified by OIG as information blockers will receive a zero score on their PI performance period in that calendar year. This will impact the MIPS-eligible clinicians’ total MIPS score unless an exception applies, or the MIPS-eligible clinician is not required to report measures for the performance category. This applies individually even if reporting as a group, although groups may also be impacted. 
• MSSP: Accountable Care Organizations (ACO), ACO participants or ACO providers or suppliers identified by OIG as information blockers may be ineligible for participation in MSSP for at least one year, impacting potential revenue. 

While HHS’ final rule made a few, slight modifications from the proposed rule, there are several issues that need to be addressed. These include the absence of a clear and consistent appeals process, rigid MIPS disincentives, and HHS' lack of attention to physician education and the importance of implementing corrective action plans instead of imposing CMS penalties. 

A summary of the rule is available on HHS’ website (PDF). All information blocking allegations must be investigated by the OIG prior to any disincentives being imposed. Investigations are evaluated on a case-by-case basis and based on a provider or physician’s intent to block information. A summary of the OIG’s priorities for its investigations can be found on our website (PDF). Physicians who believe they are experiencing information blocking from another provider can report allegations to ONC.

The disincentives take effect 30 days after the rule is published in the Federal Register (~early August). 

In response to an ongoing health care workforce shortage that is particularly acute in rural and underserved communities throughout the United States, select bipartisan members of the Senate Finance Committee unveiled a white paper (PDF) on May 24 outlining a series of policy proposals dedicated to bolstering Medicare-supported physician graduate medical education (GME). More specifically, the white paper puts forth ideas on how to expand and improve the distribution of Medicare-supported GME slots to both rural areas and specialties in shortage, assist rural hospitals with the infrastructure needed to support new and existing residency training programs and improve federal GME data transparency and collection practices. All health care stakeholders were invited to comment on this white paper spearheaded by Senate Finance Committee Chairman Ron Wyden (D-OR) and seven other bipartisan committee members. 

Written comments (PDF) submitted by the AMA on June 24 were largely supportive of the various policy proposals included in the GME white paper. With the United States facing a shortage of between 13,500 and 86,000 physicians by 2036, the AMA pressed the working group to expeditiously pass legislation that would dramatically increase the total number of Medicare-supported GME slots. Since the Balanced Budget Act of 1997 restricts the amount the federal government contributes to physician residences through limits on the number of resident full-time equivalent (FTEs) and per resident amounts (PRAs), the letter pushes for this statutory cap to be immediately repealed.  Although appreciative of the 1,200 additional Medicare-supported GME slots that Congress allocated following enactment of 2021 and 2023 Consolidated Appropriations Acts, the AMA urges further action via enactment of H.R. 2389/S. 1302, the Resident Physician Shortage Reduction Act, bipartisan legislation that makes a total of 14,000 new federally supported residency slots available over seven years.  

Since the physician workforce shortage affects all physicians, the letter also urges the working group to avoid any specialty-specific GME slot distribution proposals. Furthermore, AMA highlights the need for additional funding for the Teaching Health Center Graduate Medical Education (THCGME) program and the National Health Service Corps (NHSC), the importance of enacting federal cap flexibility legislation, as well as the creation or continuation of robust federal loan repayment and scholarship programs. The letter also stresses the importance of Congress passing legislation to permanently extend the current telehealth flexibilities enacted following the COVID-19 Public Health Emergency. Finally, the AMA urges the working group to reject proposals to create a new, temporary 9-member GME Policy Council that would assist with the distribution of Medicare-supported GME slots.  

In addition to submitting individual comments, the AMA cosigned a complementary letter (PDF) to the Senate Finance working group spearheaded by the Graduate Medical Education Advocacy Coalition (GMEAC). While it notes the coalition’s long-standing advocacy in favor of the Resident Physician Shortage Reduction Act, the letter encourages Congress, in recognition of ongoing fiscal challenges, to pass legislation providing at least an additional 10,000 Medicare-supported residency slots. Finally, the GMEAC letter also urges the working group to reject any specialty-specific slot distribution criteria and to include stringent statutory language directing the executive branch to adhere to the GME distribution methodologies outlined in any forthcoming legislation. 

AMA appreciates the Senate Finance Committee’s leadership on this issue and will continue to press the working group to develop legislation that matches the AMA’s GME policy priorities. Learn more about this issue by watching a recently recorded AMA Advocacy Insights webinar, “What’s exacerbating the physician shortage crisis—and what’s needed to fix it.”

On June 13, the Food and Drug Administration (FDA) released its new guiding principles for machine learning-enabled medical devices (MLMDs). The principles, developed in coordination with Health Canada and the United Kingdom’s Medicine and Healthcare Products Regulatory Agency, outline the three agencies' recommendations on how manufacturers of MLMDs should approach transparency with respect to their products. The document lays out several recommendations under a “who, why, what, where, when, how” rubric. The principles stress the importance of transparency in building trust, the need to provide clear information that could impact risks and patient outcomes, and the need to provide that information in an appropriate, accessible manner to physicians and patients.  
 
The guiding principles are largely in line with AMA’s Principles for Augmented Intelligence Development, Deployment and Use (PDF), approved by the AMA Board of Trustees in Nov. 2023. However, the guiding principles do not represent formal guidance or regulation from the FDA, meaning they are not mandatory requirements for device manufacturers. AMA has strongly advocated for mandated transparency requirements and updated labeling requirements for AI-enabled medical devices. The AMA has been advocating for transparency requirements for AI-enabled health care technologies with both the Administration and with Congress. 

• June 28, 2024: Medicare Payment Reform Advocacy Update