Healthcare Groups Challenge Proposed Regulations
Healthcare provider organizations are mounting significant opposition to the Drug Enforcement Administration’s (DEA) proposed special registration framework for telehealth prescribing of controlled substances. Both the American Hospital Association (AHA) and the Association of American Medical Colleges (AAMC) have formally submitted comments requesting substantial amendments to the January proposal.
The framework, which would create three registration types for clinicians to prescribe Schedule II-V controlled substances via telehealth, represents the DEA’s first attempt to implement the special registration directive mandated by the Ryan Haight Act of 2008.
“This long-awaited proposal has unfortunately fallen short of industry expectations,” noted healthcare policy experts tracking the developments. The timing is particularly significant as telehealth adoption has dramatically increased since the COVID-19 pandemic began.
50% Threshold Faces Strong Criticism
The most contentious element of the proposal is the 50% threshold restriction for telehealth prescriptions of Schedule II controlled substances like Adderall and Ritalin. This limitation would cap telehealth-based Schedule II prescriptions at less than half of a clinician’s total Schedule II prescriptions.
AAMC leadership condemned this restriction as “overly burdensome, infeasible, arbitrary” and warned it “will jeopardize patient care and will not assist the DEA in its anti-diversion goals.” The AHA echoed these concerns, also calling for the removal of this percentage-based limitation.
PDMP Requirements Under Scrutiny
The proposed Prescription Drug Monitoring Program (PDMP) check requirements have also drawn significant criticism. While the DEA’s plan ultimately aims to implement a nationwide PDMP check within three years, the interim requirements are viewed as problematic.
Current proposals require telehealth prescribers to check PDMPs in:
- The state/territory where the patient is located
- The state/territory where the prescriber is located
- Any state/territory with PDMP reciprocity agreements with these locations
While supporting the eventual nationwide PDMP and checks in patient/prescriber locations, the AAMC specifically requested removing the reciprocity agreement requirement and viewing it as an unnecessary administrative burden.
Additional Registration Concerns
The AHA raised additional concerns regarding the requirement for healthcare practitioners to complete separate state registrations for every state where they treat patients. Instead, they proposed modifying the general registration form to include a question about states where telehealth prescription patients are located.
Furthermore, the hospital group requested a full year implementation period after the rules are finalized to allow healthcare systems adequate time to adapt to the new requirements.
Future of Pandemic-Era Flexibilities
As the DEA addresses stakeholder feedback, another critical decision looms regarding pandemic-era flexibilities. The current allowance for healthcare practitioners to prescribe controlled substances via telehealth without prior in-person medical evaluation expires on December 31, 2025.
This widely utilized flexibility remains popular among practitioners, and its potential expiration adds another layer of uncertainty to the evolving telehealth prescribing landscape.
Healthcare organizations, including ATA Action, continue to voice concerns as they advocate for telehealth regulations that balance appropriate oversight with accessible patient care.
Industry Response and Next Steps
The comments from AHA and AAMC follow similar concerns raised by other organizations like ATA Action, demonstrating widespread industry apprehension about the proposed framework. Many healthcare organizations acknowledge the importance of appropriate safeguards but argue the current proposal goes too far.
“Finding the right balance between preventing diversion and ensuring legitimate patient access is challenging,” noted a telehealth policy analyst. “However, these regulations as currently proposed risk swinging the pendulum too far toward restriction at the expense of patient care.”
The DEA now faces the complex task of evaluating these stakeholder comments and determining whether to revise its proposed framework before finalization. Healthcare providers, patients, and policy experts will be watching closely as these regulations will significantly shape the future of telehealth prescribing in America.
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