December 1, 2022

Volume XII, Number 335

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MintzRx — Digital Health Update: Federal Government Shows Growing Enforcement Interest in Online Prescribing of Controlled Substances

Health care stakeholders across the industry are keeping close tabs on whether the current COVID-19 public health emergency declaration will be extended past October 13, 2022 and whether the various non-permanent flexibilities around telehealth services will correspondingly be extended. However, earlier this summer, increased oversight of medications prescribed via telehealth visits came to the surface as a consideration against the numerous benefits of the increased availability of telehealth services during the COVID-19 public health emergency.

In particular, the concept of prescribing controlled substances following telehealth visits has drawn recent scrutiny from the Department of Justice (DOJ). In response to government inquiries into certain digital health companies with platforms that connect individuals with health professionals who could evaluate them and write prescriptions following telehealth visits, some pharmacies have announced they would stop filling prescriptions. Other pharmacies have blocked or delayed prescriptions for controlled substances ordered by clinicians working for these companies.

The federal government’s respective inquiries into digital health companies and pharmacies’ ensuing reactions to those investigations should serve as a reminder for these various stakeholders to ensure they are complying with federal and state law regarding prescribing controlled substances. The Drug Enforcement Administration (DEA) has published a helpful chart titled “How to Prescribe Controlled Substances to Patients During the COVID-19 Public Health Emergency”. The DEA’s chart includes a decision tree based on whether the prescriber has previously examined the patient in person and accounts for whether the patient has experienced a substance use disorder.  Specific to prescribing through telemedicine, it offers a reminder that pursuant to evaluating patients via telemedicine prior to prescribing, the practitioner “must use his/her sound judgment to determine that s/he has sufficient information to conclude that the issuance of the prescription is for a bona fide medical purpose.”  How digital health companies move forward and potentially revamp their online prescribing practices based on government interest and enforcement activity will be worth watching.

©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume XII, Number 271
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About this Author

The health industry is a complex system, and reimbursement is the lifeblood. Reduction in payments from governmental and commercial payors affects providers, suppliers, manufacturers, and all others across the health care continuum.

Regulatory approval and accreditation is the heart of the system. For many, delay in licensure and other regulatory approvals can threaten financing and corporate viability. Accreditation of residency training programs is essential to the vitality of academic medical centers and teaching hospitals.

Restructuring is a fact of life in this dynamic...

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