iIn the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). Utah H.B. 152. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing.[1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306. While providers have been required under the Online Prescribing Act to obtain a comprehensive patient history and assessment prior to issuing a prescription, at present, this may be done via telehealth. Utah Code § 58-83-305. Once signed into law, the effect of H.B. 152 would be to make asynchronous telehealth-only prescribing unlawful in the state, with Utah’s law on the scope of telehealth practice amended to prohibit “diagnos[ing] a patient, provid[ing] treatment, or prescribe[ing] a prescription drug based solely on . . . an online questionnaire; []an email message; or []a patient-generated medical history. Utah H.B. 152, amending Utah Code § 26-60-103.
Utah’s bill may be an effort to curtail online prescribing of medication abortion in the state. States and the federal government have been taking sides on the ability of pharmacies to dispense mail-order medications used for abortion. On February 1, 2023, Utah’s Attorney General, Sean Reyes joined 19 other states’ attorneys general to send letters to two national pharmacy companies in response to those pharmacy chain’s decisions to dispense medication abortion via mail-order prescribing. The 20 states’ Attorneys General, who were led by Attorney General Andrew Bailey of Missouri, alleged that any online dispensing of medications used for abortion would not only violate their states’ laws, but also would possibly implicate the federal Comstock Act, which was enacted in 1873 and prohibits the mailing of “[e]very article or thing designed, adapted, or intended for producing abortion,” as well as “[e]very article, instrument, substance, drug, medicine, or thing which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion.” 18 U.S.C. § 1461.
Earlier in the year, the U.S. Department of Justice (“DOJ”) opined that the United States Postal Service (“USPS”) could still mail medications used for abortion because DOJ interpreted the Comstock Act to apply to “unlawful use.” The 20 states’ Attorneys General disputed this interpretation in their letter. Then, on February 16, 2023, 23 states’ Attorneys General sent a letter in support of the two pharmacy companies’ online dispensing of medication used for abortion. While the Utah legislature may be acting in response to the online prescribing of medication abortion, a repeal of the state’s Online Prescribing Act may have widespread implications for all telehealth providers operating in the state.
Outside of the medication abortion context, other states have turned their attention to online pharmacies and telehealth providers. For example, the State of California recently reached a $15 million settlement with the online telehealth provider The Pill Club, which provides prescriptions to people who menstruate based on a “self-screening tool” and short telehealth visits with nurse practitioners. California’s DOJ alleged that The Pill Club falsely billed for services by coding services as synchronous telehealth visits instead of based on the questionnaire, and billing for items such as female condoms and emergency contraceptives in excess of medical necessity and at rates higher than retail prices.
In Washington state, the Medical Commission recently issued a Statement of Charges against a physician practicing telemedicine in the state, finding that the physician treated four patients after each patient had submitted a questionnaire through the physician’s website. The charges emphasize that the physician did not have a previously established physician-patient relationship and prescribed medication based “solely on a review of an online questionnaire,” and ultimately alleging that the physician violated the standards of professional conduct for licensees.[2]
In addition to state-specific laws and rules that may place restrictions around prescribing both controlled and non-controlled substances via telehealth or otherwise, all prescribers must comply with federal law and Drug Enforcement Agency (“DEA”) regulations to prescribe controlled substances. Accordingly, rapidly changing state laws must be read together with existing federal requirements and in the context of other types of guidance released by different federal enforcement agencies, all of which is also in a state of flux.
Last July, the Department of Health and Human Services’ Office of Inspector General (“OIG”) published a Special Fraud Alert detailing high-risk activities conducted by telehealth providers and has, to date, indicted 31 telehealth providers alleging various health care fraud and abuse schemes.
At the federal level, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the Controlled Substances Act that established controls on the remote prescribing of controlled substances. The Ryan Haight Act amendments established a general telehealth prescribing requirement that, in order for a controlled substance prescription to be valid, it must be issued for a legitimate medical purpose by a practitioner who is acting in the usual course of his/her professional practice and who has conducted at least one (1) in-person medical evaluation of the patient, unless a narrow exception applies. 18 U.S.C. § 829.
Under 21 U.S.C. § 802(54), the “practice of telemedicine” means the remote practice of medicine in accordance with applicable federal and state laws, using an audio-visual, real-time, two-way interactive communication system, which practice is being conducted: (1) while the patient is being treated by, and physically located in, a DEA-registered hospital or clinic, and the remote prescribing practitioner is acting in the usual course of professional practice, in accordance with applicable state law, and is registered with the DEA in the State in which the patient is located; or (2) while the patient is being treated by, and in the physical presence of, a practitioner that is acting in the usual course of professional practice, in accordance with applicable state law, and is registered with the DEA in the State in which the patient is located. Additional, but narrower and less common scenarios also qualify as the “practice of telemedicine” as defined in 21 U.S.C. § 802(54), including circumstances designated by the U.S. Attorney General and the Secretary of Health and Human Services through regulation.
During the PHE, state and federal prescribing requirements were relaxed, which generally made it easier for health care providers to prescribe controlled and non-controlled substances to patients without ever conducting an initial in-person visit with the patient prior to issuing the prescription. Until the expiration of the federal PHE, set for May 11, 2023, the DEA has allowed DEA-registered practitioners to operate under an emergency waiver so they could prescribe controlled substances without ever having conducted an in-person visit with the patient, provided other criteria were satisfied (including that the practitioner conducted an evaluation of the patient via telemedicine using a synchronous, two-way, audio-visual communications device).
Without DEA rulemaking, and outside of the PHE, federal prescribing requirements would revert to their pre-pandemic state. However, last week, on February 24, 2023, the DEA announced proposed permanent rules around prescribing controlled substances via telemedicine that would permanently extend certain telemedicine prescribing flexibilities adopted during the PHE, with added safeguards. Under the proposed rules, where a practitioner and patient established a telemedicine relationship during the PHE and where the practitioner, relying on the DEA waiver, prescribed Schedules II-V controlled substances to the patient without conducting an in-person medical evaluation of the patient, practitioners would be given 180-days to come into compliance with in-person evaluation requirements.
Under the DEA’s proposed rules, there also would be new circumstances under which a practitioner could prescribe controlled substances via telemedicine without first conducting an in-person medical evaluation. The general premise remains the same—in that, regardless of any less restrictive state laws, in order to prescribe a controlled substance, a practitioner must have conducted at least one (1) in-person visit of the patient unless a limited exception applies. Exceptions to the DEA in-person requirement would exist where a prescriber is covering for another practitioner who has conducted an in-person examination of the patient within the previous two (2) years (i.e., a cross-coverage situation), or where the prescriber is engaged in the “practice of telemedicine,” as that term is narrowly defined by 21 U.S.C. § 802(54).
Pursuant to the authority granted in 21 U.S.C. § 802(54)(G), the proposed rules add additional circumstances that qualify as the “practice of telemedicine,” which would allow practitioners to prescribe controlled substances based on telemedicine encounters without personally conducting an in-person medical evaluation of the patient. The proposed rules would allow practitioners to: (1) prescribe up to a thirty (30) day supply of Schedules III-V non-narcotic controlled medications, (2) prescribe up to a thirty (30) day supply of buprenorphine for the treatment of opioid use disorder, and (3) prescribe any schedule of controlled medication, including narcotics, where there is a qualifying telemedicine referral from a practitioner who has conducted an in-person medical evaluation of the patient. In the first two circumstances described, in order to prescribe any amount of the medication over the thirty (30) day supply, the practitioner must conduct a medical examination, which may be accomplished via an audio-visual interactive technology, where the patient is in the physical presence of another DEA-registered practitioner.
The public has thirty (30) days to review and comment on the proposals (separately published as they relate to buprenorphine and Schedule III-V non-narcotics), after which the DEA will then consider submitted comments before drafting final regulations.
States can, and do, impose additional restrictions on prescribing, but state law cannot be less restrictive than federal prescribing requirements. Notably, the DEA requirements discussed above only apply to controlled substances, while common drugs used for medical termination of pregnancy (including mifepristone and misoprostol) are not controlled substances. Accordingly, states are free to put additional restrictions on prescriptions for non-controlled substances, as Utah and many other states have done, with many specifically targeting non-controlled substances used to terminate pregnancy.
Importantly, however, states are also free to impose stricter requirements around prescribing controlled substances. For example, the State Medical Board of Ohio’s new telehealth prescribing rule at Ohio Admin. Code 4731-11-09, which goes into effect on February 28, 2023, adds additional restrictions around prescribing Schedule II controlled substances to patients not physically examined by the prescriber. In Ohio, in order to prescribe a controlled substance without an in-person visit, a federal exception must apply (e.g.,, the originating site is a DEA registered hospital or clinic, or the patient is in the physical presence of another DEA registered practitioner), and another exception must apply, such that the prescription is for a hospice or palliative patient, is for substance use disorder treatment, is for a mental health condition, or is needed in an emergency situation.
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During the PHE, access to telehealth services, including telehealth-facilitated prescriptions for both non-controlled and controlled medications, greatly increased. With the end of the PHE fast approaching, health care providers and especially those with prescribing authority must pay close attention to federal prescribing requirements and rapidly evolving state and federal laws. Especially given recent examples of enforcement in the telehealth space, many of which focus at least in part on prescribing practices, and states’ aggressive posturing on medication-assisted termination of pregnancy, health care providers may soon be facing an environment of heightened scrutiny for telehealth prescribing.
FOOTNOTES
[1] https://le.utah.gov/documents/aboutthelegislature/billtolaw.htm.
[2] Statements of Charges may be found on the Washington State Department of Health website, filed under the individual provider’s name and/or license number.
