July 26, 2024: National Advocacy Update

The AMA, working in tandem with national and state medical societies, is raising strong, unified opposition to federal legislation that expands the scope of practice of pharmacists.

On July 23, the AMA, along with 92 federation partners, sent a letter (PDF) to House and Senate leadership in opposition to H.R. 1770/S. 2477, the Equitable Community Access to Pharmacist Services Act. All 50 state medical associations cosigned the letter due to the fact that the legislation would, “inappropriately allow pharmacists to perform services that would otherwise be covered by a physician, test and treat patients for certain illnesses (including illnesses that address a public health need or relate to a public health emergency), and expand Medicare payment for pharmacists in limited but significant ways.” 

In particular, the coalition letter highlights how the legislation seeks to permit pharmacists to evaluate and manage patients for the testing or treatment of COVID-19, influenza, respiratory syncytial virus (RSV), or streptococcal pharyngitis (strep throat). Despite claims to the contrary, the legislation fails to adhere to state scope of practice requirements. Instead, the bill simply requires pharmacists to be licensed in the state in which they work, which is standard practice, but the legislation does not revert back to, nor does it mandate that services need to be performed in accordance with state practice of medicine laws. The letter specifically critiques the bill for,  

“…allowing pharmacists, simply because they are licensed in a specific state in that profession, to initiate drug regimens, administer drugs, and generally treat certain illnesses, [which] could cause major complications for patients when their complete health is not adequately considered or adequately documented within an electronic health record.” 

While pharmacists play an important role in the health care delivery system, only physicians complete a medical residency that properly trains them to identify serious illnesses, perform differential diagnoses, conduct tests, develop treatment plans, and prescribe medications. The letter states, “Without a comprehensive physical exam by a trained professional done in the full context of the patient’s health, the severity of an illness is easily under-appreciated, and the underlying causes of the symptoms may be overlooked.” 

The letter also references the troubling trend of pharmacists, irrespective of whether they work in a community-based or chain store, being overworked under current conditions and how adding new professional responsibilities puts patient safety at greater risk.   

“Equally concerning is the fact that pharmacists in the community setting said they already have so much work to do that everything cannot be done well.  The problem appears systemic with 71 percent of all pharmacists in a pharmacy chain setting and 91 percent of pharmacists working in community pharmacies rating their workload as high or excessively high.” 

A version of this legislation has been introduced in previous sessions of Congress but never advanced.  The coordinated push against H.R. 1770/S. 2477 is due to the fact that the bill has generated 131 House and 24 Senate cosponsors, respectively. In addition, the House Ways and Means Committee could mark-up this legislation when Congress returns from an extensive district work period in September. The AMA will continue to oppose this legislation for the remainder of 2024. 

In late June, the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare & Medicaid Services (CMS) released a Final Rule (PDF) implementing disincentives for physicians and other health care providers participating in specific Medicare programs that the Department of Health and Human Services (HHS) has determined have committed information blocking. The AMA created a summary brief (PDF) about the new final regulation. It is important to note that physicians and other health care providers will be subject to ONC and CMS’ disincentive regulations starting July 31, 2024. 

ONC has defined "information blocking" as any practice that is likely to interfere with the access, exchange or use of electronic health information (EHI), unless covered by an exception (PDF). Disincentives apply to Medicare-enrolled physicians and other providers found to have committed information blocking, but do not extend to all health care providers. Physicians and other providers must “know” that a practice is unreasonable and is likely to interfere with, prevent, or materially discourage access, exchange or use of EHI, in order to be in violation of information blocking regulations. 

ONC released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) Proposed Rule in mid-July. The HTI-2 Rule continues ONC’s efforts to advance interoperability and improve information sharing among patients, physicians, providers, payers and public health authorities. 

ONC introduced new criteria for ONC’s Health IT Certification Program, including sets of criteria to enable health IT for public health as well as health IT for payers to be certified under the program. The rule also proposes to add to the information blocking “exceptions” to address additional scenarios that have been identified by physicians and other information blocking actors. The newly proposed “Protecting Care Access” information blocking exception would address strong concerns raised by the AMA about potential information blocking consequences if a physician or another entity chooses to limit sharing of a patient’s reproductive health care information in certain circumstances. The HTI-2 Proposed Rule also proposes to require the adoption of United States Core Data for Interoperability (USCDI) version 4 by Jan. 1, 2028. 

On July 22, the AMA sent a letter (PDF) recommending the need for additional information about the Drug Enforcement Administration’s (DEA) proposed ruling to reschedule “marijuana” (also known as cannabis) to a Schedule III Controlled Substance. “Marijuana” currently is classified as a Schedule I Controlled Substance.  

The letter emphasizes several key considerations regarding the proposed rule. These include the need to:  

• Ensure public health and safety, especially for vulnerable populations (e.g. youth, adolescents, people pregnant or breastfeeding).
• Perform additional research to gather more data on the safety and effectiveness of cannabis products.
• Provide consistent regulatory oversight concerning cannabis marketing, promotion and potency of extracts and concentrates.
• Protect America’s youth and adolescents, who, according to the 2022 NSDUH, make up more than half (53% or 2.0 million) of the 3.7 million people who initiated cannabis use in the past year.
• Address other public health and practical concerns, including public health-based strategies over incarceration of individuals with cannabis for personal use and DEA guidance on how physicians are expected to prescribe the drug.

The AMA stressed the importance of evidence-based practice and urged the DEA to consider the limited, available research when deciding to reschedule cannabis. At the same time, the AMA also raised concerns about the practical implications of rescheduling, which were largely unaddressed in the proposed ruling. “Given the extreme patchwork of state cannabis laws, the AMA sees this as an incredibly daunting challenge, but one that must be fully addressed if cannabis is to be rescheduled” said AMA CEO and EVP James L. Madara, MD. 

The Department of Veterans Affairs (VA) Office of Academic Affiliations (OAA) is initiating the VA Pilot Program on Graduate Medical Education and Residency (PPGMER) under the authority of the MISSION Act of 2018, P.L. 115-182 §403. This request for proposals (RFP) provides the opportunity for ACGME-accredited programs to apply for reimbursement of the proportionate costs of stipends and benefits for individual resident physician’s clinical rotations at priority covered facilities through the PPGMER. Eligible sites include those operated by the Indian Health Service, Indian Tribes, Tribal organizations, Federally Qualified Health Center programs and Department of Defense facilities, among others.    

Sponsoring Institutions (SIs) will create an online account and apply via the Online Application Program, which is expected to be posted in early August. The application deadline is Sept. 30, 2024, and is applicable for Resident Rotations within Academic Year 2025. Award notifications will be communicated to SIs in Nov. 2024. Those interested in learning more may attend one of two informational webinars on July 25 at 2 p.m. Eastern and Aug. 21 at 2 p.m. Eastern.    

Learn more on the VA website. 

• July 26, 2024: Advocacy Update spotlight on congressional action on Medicare physician payment
• July 26, 2024: Medicare Payment Reform Advocacy Update