New rules issued for telemedicine prescribing
On Jan. 17, the Drug Enforcement Administration (DEA) published two long-awaited regulations on prescribing controlled substances when the physician and patient have not had an in-person encounter.
The first is a final rule (PDF) expanding the ability to prescribe buprenorphine for the treatment of opioid use disorder (OUD) when the physician has not evaluated the patient in-person. Although the final rule specifies that it takes effect on Feb. 18, 2025, a subsequent executive order issued by President Trump suggests that this date is likely to be extended as the rule is reviewed by the new administration.
The final rule on buprenorphine, issued jointly by the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA), provides much greater flexibility than the proposed rule and adopts several recommendations that the AMA made in a March 2023 comment letter (PDF) and at a DEA listening session (PDF) in Sept. 2023. While the proposed rule would have required patients to have an in-person visit as a condition of being prescribed buprenorphine to treat OUD beyond 30 days, the final rule extends the period that patients can be prescribed buprenorphine for OUD based on audio-only visits to six months. After six months, prescriptions can be based on a different telemedicine modality, such as audio-video, or an in-person visit. In addition, the final rule removes special recordkeeping and documentation requirements that the AMA had opposed. To address concerns about buprenorphine diversion, the rule requires prescribers to review the patient’s state prescription drug monitoring program data and requires dispensing pharmacists to verify the patient’s identity prior to filling the prescription.
The second is a new proposed rule (PDF) on special telemedicine registrations for prescribing Schedule II-V controlled substances other than buprenorphine when the patient and physician have not had an in-person encounter. The proposed rule replaces a proposal issued in 2023 and currently has a comment deadline of March 18, 2025. Like the buprenorphine rule, this date and the future of the proposed policy are uncertain as they also are likely to require review by the new administration before any further action is taken. The DEA previously extended the COVID-era policies (PDF) on prescribing controlled substances based on telemedicine visits through the end of 2025, however, so the further delays in these rules may have limited impact.
The new DEA proposed rule establishes three different categories of “special registration” for prescribing or dispensing controlled substances:
- One for physicians and qualified health professionals who prescribe controlled substances in Schedules III-V
- One for specialists such as psychiatrists and hospice medicine physicians to prescribe Schedule II-V controlled substances via telemedicine
- One for covered online telemedicine platforms to dispense Schedule II-V controlled substances
The special registrations would also require state telemedicine registrations for every state in which a patient is treated by the special registrant. These special registrations would only be required when the prescriber has never conducted an in-person medical evaluation of the patient prior to issuing the prescription. Physicians who prescribe controlled substances based on telemedicine encounters when an in-person visit has occurred at some point with the patient would not need to use the special registration process. The AMA plans to review the proposed rule and develop comments on it.
FTC publishes second report on PBM impacts on drug prices
On Jan. 14, the Federal Trade Commission (FTC) released its second interim staff report on drug middlemen and their impact on prescription drug prices and access. The FTC commissioners voted unanimously to release the bipartisan report, which focuses on pharmacy benefit manager (PBM) influence over specialty generic drugs. The report found that the “big three” PBMs—Caremark (CVS), Express Scripts, and Optum—marked up numerous specialty generic drugs by hundreds or thousands of percent, resulting in $7.3 billion in revenue over the study period. The markups impacted numerous generic specialty drugs, such as treatments for cancer, HIV and numerous others to treat serious diseases and conditions. The report also found that PBMs reimbursed “affiliated pharmacies”—usually those considered to be controlled or owned by the PBM—at higher rates on nearly every drug examined in the report than they reimbursed unaffiliated pharmacies.
Annual report on mental health parity and addiction equity highlights denials and delays in care
The U.S. Departments of Labor (DOL), Health and Human Services (HHS), and Treasury released their 2024 report to Congress (PDF) on the implementation of the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (MHPAEA). The Departments determined, for the third consecutive year, that health plans continue to deny and delay mental health and substance use disorder (MH/SUD) care for millions of Americans through the use of impermissible “non-quantitative treatment limitations,” (NQTL) which include policies such as prior authorization. The AMA summarized the 2024 report (PDF).
MHPAEA was enacted in 2008, and the final regulations were issued in 2013. The act requires group health plans and health insurance issuers offering group and individual health insurance coverage that offer MH/SUD benefits to cover those benefits in parity with medical and surgical (M/S) benefits, without imposing greater restrictions on MH/SUD benefits as compared to M/S benefits. State and federal regulators share aspects of MHPAEA oversight and enforcement.
The 2024 report describes how health plans continue to fail to provide legally required accurate comparative analyses of NQTLs, as every NQTL comparative analysis submitted by health plans that was reviewed was insufficient. The Departments stated throughout the report that the plans’ explanations were overly generalized, implausible, and not convincing. The report also details how health plan networks are grossly inadequate, and one of the reasons that tens of millions of Americans cannot find or access timely treatment for MH/SUD care is due to health plans’ failures to maintain adequate—or accurate—networks of MH/SUD providers. Secret shopper surveys found that only 8 to 28 percent of patients were able to obtain care from MH/SUD provider networks listed as accepting new patients—compared to 24 to 37 percent of M/S providers surveyed.
In addition, the report found that reimbursement/contract rates for MH/SUD providers were typically much lower than for M/S providers and that health plans routinely took longer to credential MH/SUD providers than M/S providers. Moreover, the report said that health plans’ “deficiencies and trends” in the 2024 report are the same as in the 2022 and 2023 reports, which were mainly due to “inadequate preparation by plans and issuers, and plans and issuers attempting to justify practices that were adopted without MHPAEA compliance in mind.”
AMPAC Candidate Workshop: In person March 28-30
AMPAC is excited to announce that the 2025 AMPAC Candidate Workshop will be held in person—March 28-30—at the AMA offices in Washington, D.C. Registration is now open.
Do you ever wonder how doctors get elected to Congress or your state legislature? Are you considering a run for office for yourself? The AMPAC Candidate Workshop will teach you how to run a winning political campaign. The Candidate Workshop is designed to help physicians make the leap from the exam room to the campaign trail and give the skills and strategic approach needed to make a run for public office.
At the Candidate Workshop, Republican and Democratic political veterans work together to give you expert advice about being a successful candidate and how to run a winning campaign. You will learn:
- The importance of a disciplined campaign plan and message
- The secrets of effective fundraising
- What kinds of advertising may be right for your campaign
- How to work with the media
- How to build your campaign team and a successful grassroots organization
Attendees include AMA physician members, member spouses, residents and medical students and state medical society staff interested in becoming more involved in politics.
Registration for the 2025 AMPAC Candidate Workshop is now open. Space is limited and the deadline to register is March 7, or sooner if maximum capacity is reached.
For more information, please contact [email protected].
