June 30, 2023: National Advocacy Update

On June 22, the House Energy and Commerce Subcommittee on Oversight and Investigations held a nearly three hours-long hearing to discuss implementation and challenges of the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 and the current Medicare physician payment system.

This long overdue hearing was the first congressional oversight hearing held since 2016 when hearings were held on the newly enacted program. The hearing builds off the Congressional RFI on Medicare Payment reform (PDF) issued to stakeholders last September by Reps. Ami Bera, MD (D-CA) and Larry Bucshon, MD (R-IN), and was the result of strong advocacy by the AMA and its Federation partners calling for Medicare payment reform.

The AMA submitted a letter (PDF) to the subcommittee leadership expressing deep alarm about the growing financial instability of the Medicare physician payment system (MPS) due to a confluence of fiscal uncertainties physician practices face related to statutory payment cuts, the lack of annual inflation-adjusted payment updates that keep pace with rising practice costs, the ongoing negative impact of the pandemic and significant administrative barriers. The letter further stated that the MPS is on an unsustainable path that, without systemic reforms, jeopardizes Medicare patient access to physicians and will drive private practices out of business.

The AMA urged Congress to take the following steps to help practices keep their doors open, resist consolidation, and ensure continued access to care for beneficiaries:

• End the MACRA mandated six-year freeze on physician payment updates and pass H.R. 2474 to establish a stable, annual Medicare physician payment update that keeps pace with inflation.
• Modify statutory budget neutrality requirements by establishing a look-back period to remedy overestimates and underestimates of spending based on actual claims data, clarify which services are subject to budget neutrality and raise the spending trigger for budget neutrality adjustments.
• Improve the Merit-based Incentive Payment System (MIPS) by allowing greater flexibility to set MIPS criteria, ensuring physicians have access to actionable data, and streamlining and fine-tuning measures and methodologies.
• Extend the 5% advanced alternative payment model (APM) participation incentive payments for at least two years and halt the revenue threshold increase to encourage more physicians to transition into APMs.

The AMA is undertaking a new national study, supported by 173 health care organizations (PDF), to collect representative data on physician practice expenses. The aim of the Physician Practice Information Survey (PDF) is to better understand the costs faced by today’s physician practices to support physician payment reform. The study will serve as an opportunity to communicate accurate financial information to policymakers, including members of Congress and the Centers for Medicare & Medicaid Services (CMS). The AMA has contracted with Mathematica, an independent research company with extensive experience in survey methods as well as health care delivery and finance reform, to conduct the study.

The Medicare physician payment schedule, maintained by CMS and used by many other payers, relies on 2006 cost information to develop practice expense relative values, the Medicare Economic Index and resulting physician payments. As the U.S. economy and health care system have undergone substantial changes since that time, including inflation and the wide-spread adoption of electronic health records and other information technology systems, practice expense payments no longer accurately reflect the relative resources that are typically required to provide physician services.

The study will rely on financial experts in the practice to complete an online financial information survey. The number of direct patient care hours is a critical component of the Medicare payment methodology. Therefore, thousands of individual physicians will receive a short patient care hours survey from either their practice directly or from Mathematica. The input from physician practices and individual physicians that are randomly selected to participate in this study is critical for its success. Participation will ensure that practice expenses and patient care hours are accurately reflected.

CMS recently released the 2021 Quality Payment Program (QPP) Experience Report (PDF) to provide insights into the Merit-based Incentive Payment System (MIPS) program. The report highlights that approximately 97% of physicians avoided a 2023 negative payment adjustment based on their 2021 MIPS participation. In addition, 78% of MIPS eligible clinicians (ECs) will receive a MIPS bonus of up to 2.34%. The report also highlights that the average final score for small practices has increased substantially from the first year of the program, from 43.16 in 2017 to 73.71 in 2021, while the average final score for rural clinicians went from 63.08 in 2017 to 88.44 in 2021. This is in part due to the AMA’s advocacy for the Extreme and Uncontrollable Circumstances (EUC) hardship exception due to COVID-19, which held harmless from MIPS penalties physicians who applied as a group or automatically as individuals.

The AMA continues to actively advocate for changes to the MIPS program to make it less burdensome and more meaningful. The AMA urges practices to continue to take advantage of the COVID-19 flexibilities and apply for a MIPS EUC hardship exception to avoid up to a -9% MIPS penalty in 2025 based on 2023 performance. The exception will not be automatic, and interested physicians and groups must actively request reweighting of one or more MIPS performance categories due to the COVID-19 Public Health Emergency. Requesting reweighting of all four MIPS performance categories will avoid a MIPS penalty in 2025.

The report also includes information about physicians who participated in alternative payment models (APMs). During the CY 2021 performance year, 271,231 clinicians (identified by their NPI) who participated in an Advanced APM achieved qualifying APM participant (QP) status and earned a 5% incentive payment. The total number of ECs who achieved QP status increased by 15.31% from 2020 to 2021.

The AMA sent a June 14 letter (PDF) to the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) strongly supporting and encouraging OCR’s efforts to protect sensitive patient information, which is essential to establishing trust in the patient-physician relationship. The AMA has extensive policy advocating for maintaining the privacy of patient information, the preservation and expansion of access to reproductive health services, and the protection of physicians who provide reproductive health care and patients who receive such care.

In the letter, the AMA asked OCR to broaden the Health Insurance Portability and Accountability Act (HIPAA) of 1996 definition of patient information that will be afforded additional protections under these proposals to include other types of sensitive medical information which may subject the patient or care provider to civil or criminal liability. The letter discusses how vulnerable patient groups are increasingly being targeted by state legislation that aims to curtail their rights to access evidence-based health care. Physicians providing evidence-based health care to these individuals are fellow targets with their patients of the restrictive state laws which seek to inappropriately interfere in the patient-physician relationship.

The AMA also urged the creation of clarifying guidance to stem eroding confidence in the patient and provider community that protected health information (PHI) will not be shared beyond the wishes of, and to the detriment of, the patient and physician. The letter asked OCR to clarify that a covered entity has the right to require an attestation, at their discretion, and to decline any request for PHI when the requester refuses to provide the attestation. OCR should also clarify that a covered entity will only be found in violation of the proposed prohibited disclosure if the covered entity had contemporaneous actual knowledge that the PHI being requested was “for the purpose of investigating or imposing liability on any person for the mere act of seeking, obtaining, providing, or facilitating” sensitive personal health care.

On June 20, the AMA sent a response (PDF) to the HHS Office of National Coordinator for Health Information Technology (ONC) on the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) proposed regulation. The AMA believes that this proposed rule will help to decrease electronic health record (EHR) burdens and improve augmented intelligence (AI) transparency and medical record interoperability, while helping protect an individual’s privacy. The comments also focus on the importance of ONC finalizing policies to prevent unintended harm to patients from sharing sensitive information.

The AMA agreed with ONC that algorithmic transparency is a non-negotiable prerequisite for trustworthy AI. This regulation is the federal government’s first major effort to establish regulatory guardrails on AI transparency. With rapidly evolving AI tools in health care, the AMA supported ONC’s use of its Health IT Certification Program to surface information about AI development, training, risk and fairness. The AMA backed ONC’s vision to promote greater trust in decision support interventions (DSI) and predictive models through the Certification Program. The AMA also wants to continue to refine existing policies to ensure that the perspective of physicians in various practice settings informs future AI oversight.

In response to AMA advocacy, ONC will allow patients to flag data that needs to be restricted from subsequent use or disclosure by supporting ONC’s proposals that certified health IT must provide those functionalities. ONC’s rule converged with the HHS Office for Civil Rights Proposed Rule to Support Reproductive Health Care Privacy—the AMA emphasized that the proposed reproductive health privacy protections may fall short of desired goals if there is a lack of certified technology and if ONC neglects to adequately educate those involved in interpretating, implementing and operationalizing its own policies. The AMA strongly advocates for patients to control where and when they view or are alerted to new medical information. However, the letter underscored that privacy-enabled technology and policies have not kept up with the volume and velocity of information sharing—putting patients and their data at risk of abuse and misuse.

Moreover, the AMA strongly supported the Insights Condition and Maintenance of Certification requirements and ONC’s proposals to help EHR users, federal entities and the health IT industry better evaluate the functional interoperability of EHRs.

New federal educational requirements regarding management of substance use disorders (SUD) take effect this week for physicians applying for or renewing their registration with the Drug Enforcement Administration (DEA) to prescribe controlled substances. DEA registration covers a 3-year period, so as physicians’ registrations come up for renewal over the next three years, they will need to be able to check 1 of 3 boxes that are being added to DEA forms 224 and 224A, used to apply for a new or renewal DEA registration.

The AMA opposed the new Medication Access and Training Expansion (MATE) Act training requirements and continues to be concerned about their potential unintended consequences. With its check-the-box attestation on the revised application forms, however, the DEA appears to be trying to streamline implementation of the MATE Act requirements as much as possible. There are three questions being added to the forms and a physician needs to be able to check 1 of the 3 boxes to complete their application for a DEA registration or renewal:

• Whether the physician is board certified in addiction medicine or addiction psychiatry;
• Whether they graduated from medical school within the past 5 years and received 8 hours of training during their medical school or residency training on treating and managing patients with opioid or other SUDs, including use of all drugs approved by the Food and Drug Administration (FDA) for the treatment of opioid use disorder; or
• Whether a physician received 8 hours of training with one of many accredited organizations.

Drop-down menus accompanying these questions on the DEA application form provide more details if physicians have questions. In a webinar offered by officials from the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA), which is available on the SAMHSA website, the agencies note that physicians are only required to attest that they have received the training, but they are not required to submit information about their coursework or dates of training to the agency. The AMA submitted comments (PDF) to the DEA recommending several clarifications to the wording of the three questions. In addition, the AMA is continuing to seek a grace period for physicians who need to renew their DEA registration but may not be able to attest to having received the training at the time of their renewal. Please visit the AMA EdHub™ for courses that satisfy the MATE Act.

On June 22, CMS released the long-awaited Transitional Coverage for Emerging Technologies (TCET) proposal. This proposal is in follow-up to the repealed Medicare Coverage of Innovative Technologies proposal, which had proposed to provide immediate national coverage for certain medical devices but had drawn criticism for its guaranteed coverage without mandates or incentives for continued evidence development. The new TCET proposal seeks to address those concerns with a new evidence development-centric approach.

Under the proposed TCET pathway, certain medical devices receiving market authorization under the Food and Drug Administration’s (FDA) breakthrough device designation pathway would be eligible for a new coverage pathway providing earlier CMS coverage and more coverage certainty. The TCET pathway builds upon the existing FDA/CMS parallel review program and ensures CMS engagement, including benefit category review and evidence previews prior to FDA market authorization. Once a TCET-eligible device receives its FDA authorization, CMS will utilize a coverage with evidence development (CED) national coverage determination (NCD) process to provide earlier coverage while encouraging continued evidence development for eligible technologies. At the end of the TCET coverage period, CMS will engage in review of the NCD for permanent post-TCET coverage or discontinuation of the same.

The AMA is supportive of reducing coverage and payment burdens for new, high-quality, high-value medical devices and technologies. However, the AMA was concerned that the earlier iteration of this proposal did not adequately provide for appropriate evidence development and could potentially put patient safety at risk.

On June 23, the Biden administration issued an Executive Order (EO) aimed at strengthening access to contraception and family planning services. Citing continued concerns over access to the full range of health care services for women and continued state-level attempts to limit access to contraception, the EO directs federal departments and agencies to consider actions to ensure comprehensive coverage of all FDA-approved or FDA-cleared contraceptives without cost sharing and to consider actions to promote increased access to affordable over-the-counter (OTC) contraceptive options. Additionally, the EO seeks to expand access to affordable family planning services and supplies across the Medicaid program and to expand contraceptive and family planning access across programs for veterans, within Title X clinics, HRSA-funded health centers and the Indian Health Service.

The AMA is pleased to see the continued focus on access to these critical health services. The AMA in January urged (PDF) the HHS Secretary to support efforts to bring oral contraceptives over the counter and this spring supported (PDF) the application of the first progestin-only oral contraceptive to change status from prescription to non-prescription.

On June 23, the AMA submitted comments (PDF) in response to proposed federal regulations that, if finalized, would expand eligibility for Medicaid, Children’s Health Insurance Program (CHIP) and Qualified Health Plan (QHP) coverage to Deferred Action for Childhood Arrivals (DACA) recipients and certain other legal noncitizen groups. The proposed rule (PDF) would also expand certain insurance affordability programs to these groups.

In the comments, the AMA expressed overall support for the proposed policies, reiterating its commitment to advocating for expanded health insurance coverage for all and a health system that is focused on increasing equity and access. The comments noted that expanding coverage to these groups would improve the health of these populations and likely have economic benefits as well. The AMA also encouraged the agency to specifically list groups that would qualify, including victims of human trafficking, to further reinforce protections.

• June 30, 2023: Advocacy Update spotlight on prior authorization regulations
• June 30, 2023: State Advocacy Update