WASHINGTON – Today, U.S. Sens. Mark R. Warner (D-VA) and John Thune (R-SD) led a group of colleagues in a letter to Anne Milgram, Administrator of the Drug Enforcement Administration (DEA), expressing support for the agency’s new engagement on a potential special registration for telehealth but sharing serious concerns over the agency’s proposed rules on the future of prescribing controlled substances via telehealth. Despite efforts by Sen. Warner to ensure continued access to telehealth services following the end of the COVID-19 Public Health Emergency (PHE), the DEA’s rules as proposed would drastically affect patient care.

Joining Sens. Warner and Thune in this letter are U.S. Sens. Catherine Cortez Masto (D-NV), Shelley Moore Capito (R-WV), Sheldon Whitehouse (D-RI), and Dan Sullivan (R-AK).

At the start of the pandemic, the DEA acted swiftly to take advantage of exceptions detailed in the Ryan Haight Online Pharmacy Consumer Protection Act that allowed the agency to waive in-person requirements for prescribing controlled substances in the case of a Public Health Emergency (PHE). With the expiration of the COVID-19 PHE earlier this year, however, the DEA announced a proposed rule detailing their plans for prescribing these medications via telehealth going forward that would limit the ability of doctors to prescribe controlled substances without an in-person visit and place unnecessary requirements on care providers. The proposed rule would only allow a 30-day supply of a schedule III-V non-narcotic medication prior to an in-person medical evaluation, and would not permit any initial supply for schedule II or schedule III-V narcotic medication.

The senators wrote, “Although we appreciate the limited flexibilities proposed by the rule, they are insufficient to meet the health care needs of our constituents and the needs of the providers who care for them. We support the Drug Enforcement Administration (DEA) extending the full set of telehealth flexibilities through November 2023 and are encouraged by the upcoming public listening sessions on the proposed regulations. We urge the DEA to consider feedback from health care stakeholders and apply the lessons learned from the COVID-19 pandemic to ensure patients maintain access to care through telehealth, while still minimizing diversion and fraud.”

Highlighting the difficulty patients have scheduling in-person appointments, the senators continued, “We have concerns about our constituents’ ability to obtain in-person appointments within 30 days of starting a new medication, and the potential consequences to their health of starting a new medication and abruptly ending it should they not be able to obtain such an appointment. It takes on average 26 days to schedule a new patient appointment with a health care provider. Therefore, a 30-day supply could result in patients going without their medication while they wait for an in-person appointment or will turn to higher-acuity and higher-cost settings of in-person care to meet this deadline, such as emergency departments.” 

The senators also called attention to a rule Congress created as part of the SUPPORT for Patients and Communities Act that requires the DEA create a registration for telemedicine practitioners who would not be subject to mandatory in-person medical evaluations. The goal of this special registration is to allow medical evaluations over telehealth more broadly, which the senators state this DEA rule does not accomplish.

Over the course of the COVID-19 pandemic, tremendous progress was made to ensure that patients could receive care without interruption. Reinstating these hard limits on telehealth would be taking a step backwards, and have serious impacts on the care options for thousands of patients. Sen. Warner has consistently led efforts to expand telehealth accessibility, introducing legislation to expand telehealth services and repeatedly calling on congressional leadership to extend telehealth services after the end of the pandemic.

 

A copy of the letter is available here and text is below:

 

Dear Administrator Milgram:

 

On behalf of our constituent patients, health care providers, and pharmacists, we’re writing to share strong concerns with the notice of proposed rulemaking on the future of controlled substances prescribing over telehealth. Although we appreciate the limited flexibilities proposed by the rule, they are insufficient to meet the health care needs of our constituents and the needs of the providers who care for them. We support the Drug Enforcement Administration (DEA) extending the full set of telehealth flexibilities through November 2023 and are encouraged by the upcoming public listening sessions on the proposed regulations. We urge the DEA to consider feedback from health care stakeholders and apply the lessons learned from the COVID-19 pandemic to ensure patients maintain access to care through telehealth, while still minimizing diversion and fraud.

 

Proposed Rule

As you know, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Ryan Haight Act”) offered seven exceptions to the in-person medical evaluation requirement when providers are engaged in the “practice of telemedicine;” a public health emergency is one such exception, and we’re grateful the DEA moved swiftly to utilize that exception during the COVID-19 pandemic.

 

However, we are concerned that the proposed rule undermines the gains made during the PHE that saw expanded access to critical health care services through telehealth

 

Initial supply: Prior to an in-person medical evaluation, the proposed rule permits a DEA-registered prescriber to provide an initial 30-day supply of a controlled substance for non-narcotic schedule III-V medications. We have concerns about our constituents’ ability to obtain in-person appointments within 30 days of starting a new medication, and the potential consequences to their health of starting a new medication and abruptly ending it should they not be able to obtain such an appointment. It takes on average 26 days to schedule a new patient appointment with a health care provider. Therefore, a 30-day supply could result in patients going without their medication while they wait for an in-person appointment or will turn to higher-acuity and higher-cost settings of in-person care to meet this deadline, such as emergency departments.

 

Despite the 180-day grace period after the end of the PHE, new and existing patients will be seeking in-person appointments simultaneously in a health care system that is already burdened by a shortage of health care providers. According to the U.S. Department of Health and Human Services, 163 million Americans live in Mental Health Care Health Professional Shortage Areas.  Approximately 8,200 additional psychiatrists would be needed nationwide just to remove this shortage designation.  Nationwide averages also obscure the variation among states and territories; for example, Arizona has only 8.5% of its psychiatric health care needs met and would need 227 psychiatrists to meet 100% of these needs.  And beyond mental health care, 100 million Americans live in Primary Care Health Professional Shortage Areas, with more than 17,000 primary care providers needed at a minimum to remove the designation. 

 

Medical societies representing health care providers and their patients nationwide have encouraged a window of longer than 30 days for an initial prescription in order to provide enough time to obtain an appointment: the American Medical Association (AMA) and the American Psychiatric Association recommend 180 days, with the Association of American Medical Colleges (AAMC) urging no less a 90-day maximum when the provider believes it is appropriate. In addition, the AMA and the AAMC recommend that existing patients have one year to fulfill the in-person appointment requirement.

 

Provider safety: The proposed rule requires the prescribing provider to report their physical address at the time of the telemedicine appointment. Health care providers have shared they sometimes do telemedicine appointments from their home and have safety and privacy concerns with their home address being on the prescription. We urge you to allow providers to use the business address of their DEA registration.

 

Referrals:

• Referring providers: The proposed rule requires that an in-person medical evaluation be performed by a DEA-registered provider before a referral to another DEA-registered provider who would be permitted to prescribe a controlled substance over telehealth. We are concerned that individuals without adequate in-person access to a DEA-registered provider will see their health care treatment options limited should they be referred to a specialist for a telehealth appointment, or instead a second in-person medical evaluation would be required with a DEA-registered provider prior to seeing a specialist, which would increase costs to the patient and the health care system as a whole. We urge you to work with health care providers to ensure patients do not encounter any truly unnecessary barriers to care.  
• Prescribing practitioner: The proposed rule requires a referring provider to specifically include the name and National Provider Identifier (NPI) of the prescribing practitioner to which the referring prescriber is referring the patient. In practice, patients are often referred to a group practice where they see whichever specialist has a first available appointment. Or, referrals may not have a provider indicated at all, as the patient often has to explore insurance network coverage and new patient availability. This requirement may prevent patients from receiving the legitimate health care services they need.

 

Recordkeeping: Finally, we have heard widespread concerns about additional recordkeeping and other administrative burdens required from providers and pharmacies. This additional administrative burden will strain an already exhausted workforce could also deter providers from being able to provide this care. Stakeholders have shared that existing recordkeeping requirements should be sufficient for the purpose of DEA being able to combat diversion and fraud, and we encourage you to work with providers on the least burdensome path forward.

 

Special Registration

In addition to the PHE exception to the Ryan Haight Act discussed above, Congress also created a “special registration” exception, not as an option for DEA to utilize but a requirement to do so most recently in the SUPPORT for Patients and Communities Act (“SUPPORT Act”). We do not believe this NPRM fulfills DEA’s obligation to create a special registration.

 

Congress envisioned this special registration to allow certain health care providers to be cleared and registered to use their clinical judgment when a medical examination can be done over telehealth for the purposes of a controlled substances prescription. DEA envisioned this to be the case, as well: in the preamble to Ryan Haight Act implementation regulations, DEA wrote:

 

“Special registration for telemedicine—a practitioner who is engaged in the practice of telemedicine within the meaning of the Act is not subject to the mandatory in-person medical evaluation requirement of 21 U.S.C. 829(e) (although such practitioner remains subject to the requirement that all prescriptions for controlled substances be issued for a legitimate medical purpose.”

 

Although we appreciate DEA not requiring a special registration for the initial prescriptions currently proposed, we are concerned that the proposed rule does not include the special registration directed to be created by Congress and even envisioned by the DEA. However, we are pleased to see DEA recently indicate further consideration of a special registration process that would allow clinicians to prescribe a controlled substance via telemedicine without an in-person visit. We appreciate the continuation of the comment process via public listening sessions, and encourage the DEA to review and incorporate stakeholders’ feedback in future rulemaking related to telemedicine prescribing.

 

In addition to allowing qualified health care providers to determine when a medical evaluation over telehealth is appropriate, a special registration would also provide a framework to evaluate the appropriateness of certain prescribers having the ability to prescribe over telehealth medications not covered by the post-COVID-19 proposed rule, namely Schedule II medications and Schedule III-V narcotic medications.

 

Health care providers across the board continue to ask for a special registration process that would provide a pathway for certain providers to provide more care involving controlled substances over telehealth than the proposed rule allows, and we implore DEA to follow its statutory requirements under the Ryan Haight Act and the SUPPORT Act and do just that.

 

Thank you for your consideration of these concerns, and we look forward to continuing to work with you on these important issues.

                       

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