APA’s Government, Policy, and Advocacy Update (March 2023)

In a letter to the Food and Drug Administration (FDA), APA expressed its support for the FDA’s preliminary assessment that naloxone nasal spray and autoinjector formulations are safe and effective for over-the-counter use. The letter, signed by APA CEO and Medical Director Saul Levin, M.D., M.P.A., was written in response to the FDA’s request for comments on the use of naloxone for nonprescription use.

In the letter, APA encouraged the FDA to add naloxone nasal spray to the list of FDA Essential Medications. “This would open federal resources and prioritize investment in long-term domestic manufacturing.” Further, APA emphasized the importance of education on the use of naloxone so individuals can appropriately identify and respond to an overdose. Finally, APA addressed the cost barriers associated with naloxone, noting that some forms of nicotine replacement therapy are not covered by Medicare because they are over the counter. APA encouraged the FDA to work with the Centers for Medicare and Medicaid Services and other payers to keep costs down for the most vulnerable populations.

APA and its partner organizations, members of the Mental Health Liaison Group Telehealth Work Group, sent a letter Sen. Brian Schatz (D-Hawaii) and Rep. Mike Thompson (D-Calif.) providing suggestions for the reintroduction of the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act.

The groups wrote that any reintroduction of the CONNECT Act should eliminate the in-person requirement for telemental health services under Medicare as a prerequisite for coverage of a telehealth service, which was included in the Consolidated Appropriations Act of 2021. This provision is “inequitable for individuals with mental health conditions,” the letter stated. The letter emphasized the groups’ support for in-person care when clinically appropriate or desired by the patient.

“Given the immense need for mental health services combined with acute behavioral health workforce shortages, the in-person telemental health provision is counter to the intent of ensuring more Americans receive life-changing care and, in fact, could further exacerbate our nation’s growing mental health crisis,” the letter stated.

In a letter to the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office of Civil Rights, APA provided input to the proposed changes to the Confidentiality of Substance Use Disorder (SUD) Patient Records under 42 CFR Part 2 (referred to as Part 2), which protects patients’ privacy and records concerning treatment related to SUD.

The goals of the proposed changes are to improve coordination among professionals and increase protections for patients concerning records disclosure to avoid discrimination in treatment, according to a SAMHSA news release.

However, APA cautioned that the proposed rule, as written, does not do enough to mitigate data segregation and segmentation, which challenge care coordination efforts. For example, the regulation does not ease the burden of data management in integrated and collaborative care settings. “At best, psychiatrists and other specialists may have significant administrative burden added to manage and maintain patient data in separate platforms, all without the intended outcome of coordination with colleagues to support shared patients,” APA’s letter stated.

APA offered numerous recommendations, including that SAMHSA should provide one-on-one technical assistance to clinicians or facilities wanting to ensure compliance with the rule, delay the rule’s finalization, and implement public education around SUD data to empower patients when consenting to data disclosures. ■