Ranking Member Cassidy Seeks Information on New DEA/HHS Regulations for Telemedicine Prescribing of Controlled Substances

WASHINGTON – U.S. Senator Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, requested information on how the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) will implement new regulations on telemedicine that require an in-person evaluation of a patient before a physician is allowed to prescribe Schedule II controlled substances.

During the COVID-19 pandemic, DEA and HHS waived the in-person requirement for tele-prescribing of controlled substances required by the Ryan Haight Act. On March 1^st, DEA issued proposed rules that would reinstate Ryan Haight Act restrictions on tele-prescribing Schedule II controlled substances, and limit the tele-prescribing of Schedule III controlled substances to a 30-day supply before an in-person evaluation is required. Despite waiting to publish the proposed rules 60 days before the end of the COVID-19 Public Health Emergency (PHE), the Biden administration limited the rule to a 30-day public comment period. Cassidy raised serious concerns that the expedited timeline of these rules would not allow proper input from the public and puts a burden on health care providers and patients as they adjust to the new regulations.

“While I appreciate DEA’s and HHS’ efforts to provide regulatory clarity about how to prescribe controlled substances safely once the PHE expires on May 11, I have serious concerns about the basis upon which these [proposed rules] were written,” wrote Dr. Cassidy. “I am particularly concerned that DEA has had 15 years to publish these rules, and yet the public only had 30 days to review and respond to them.”

“Numerous patient groups, provider organizations, and health care systems have raised concerns that the short timeline for consideration of these rules prior to finalization will not allow them enough time to implement safe transitions for patients relying on telehealth flexibilities active during the PHE,” continued Dr. Cassidy. “To that end, I ask that you answer the following questions on a question-by-question basis by May 10, 2023.”

Read the full letter here or below. 

Dear Secretary Becerra and Administrator Milgram:

On March 1, the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) issued two notices of proposed rulemaking (NPRMs) about transitioning the prescribing of controlled substances via telemedicine into a post- COVID-19 Public Health Emergency (PHE) framework.

The NPRMs would reinstate the Ryan Haight Act restrictions on the prescribing of Schedule II controlled substances (including stimulants and some high potency opioids), requiring an in-person evaluation of the patient before a new prescription is provided.[ New prescriptions for Schedule III-V controlled substances (including benzodiazepines, Z-drugs, ketamine, Marinol, GHB, anabolic steroids, buprenorphine, tramadol and other low potency opioids) after a telehealth visit would be limited to a 30-day supply before an in-person evaluation would be required. For providers who began prescribing controlled substances for patients via telemedicine during the PHE, the NPRMs allow for a six-month grace period for providers to conduct an in-person evaluation.

While I appreciate DEA’s and HHS’ efforts to provide regulatory clarity about how to prescribe controlled substances safely once the PHE expires on May 11, I have serious concerns about the basis upon which these NPRMs were written. It is important that these rules when finalized comply with congressional mandates to ensure that controlled substances are adequately available to patients for medically indicated use and not diverted inappropriately. I am particularly concerned that DEA has had 15 years to publish these rules, and yet the public only had 30 days to review and respond to them. Numerous patient groups, provider organizations, and health care systems have raised concerns that the short timeline for consideration of these rules prior to finalization will not allow them enough time to implement safe transitions for patients relying on telehealth flexibilities active during the PHE. Further, DEA has stated that they expect to finalize the proposed rule by May 11.   

To that end, I ask that you answer the following questions on a question-by-question basis by May 10, 2023. I also request that all documents sent along with your response be transmitted electronically in PDF format.

1. Why do these rules not create a Special Registration program when Congress has directed DEA to create such a program twice, first in the Ryan Haight Act of 2008 and then in the SUPPORT for Patients and Communities Act of 2018?
2. Why is the comment period for these two NPRMs limited to 30 days instead of a 60 or 90-day window for comments, enabling fulsome consideration by Congress and the public?
3. DEA has the ability to use enforcement discretion to allow providers to prescribe controlled substances via telemedicine, which could be impacting how these proposed rules are implemented in practice. How will DEA use its enforcement discretion once these rules are finalized?
4. What data did DEA collect about diversion of controlled substances during the PHE and how was this information used in drafting the NPRMs?
   1. Did DEA consider whether certain types of providers and patients or certain modalities of care are more or less likely to be associated with diversion?
   2. Under the NPRMs, for substances in Schedules III-V, patients may obtain prescriptions for a 30-day supply before they must have an in-person visit with a prescriber. What data supports a 30-day window?
   3. What data supports a six-month transition period for individuals currently being prescribed a controlled substance that was initiated during the PHE?
   4. Has any patient harm has been caused by the PHE waivers that enabled the prescribing of controlled substances without in-person visits?
   5. What benefits did patients experience due to the waivers? Please provide quantitative and qualitative data.

5. For providers who co-locate their practice at their home, how did DEA and HHS take into consideration the privacy concerns of providers and their families in proposing to require providers to publish their address for telemedicine prescriptions?
6. How have DEA and HHS considered health care workforce shortages in its proposal to require both the referring provider who conducted the in-person evaluation and the prescribing telemedicine provider to obtain DEA numbers?
7. Have DEA and HHS accounted for the cost of updating prescribing platforms to include additional documentation designating prescriptions as originating via telehealth?
8. 1. Have DEA and HHS accounted for the cost of training providers and pharmacists to include and check for additional telehealth-specific documentation respectively?
   2. How does DEA envision pharmacists will be able to efficiently check whether a patient attempting to get a telemedicine prescription filled has had an in-person evaluation in compliance with DEA rules?
   3. What would be the pharmacist’s liability for not being able to determine this?
   4. Would the risk of liability reduce rural patients’ access to care?

9. How did DEA and HHS determine what period of time can have safely passed since a patient’s most recent in-person evaluation for them to continue being prescribed controlled substances via telemedicine?

###