Telehealth and Prescribing Controlled Substances
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In response to the COVID-19 outbreak and escalating pandemic, in January 2020 the U.S. Department of Health and Human Services (DHS) declared a federal public health emergency (PHE) that is still in effect today. The PHE declaration resulted in numerous waivers of federal laws and regulations impacting the practice of medicine, including telehealth, HIPAA, scope of practice, and Stark laws. The PHE also provides healthcare providers with COVID-related liability protections under the PREP Act. Simultaneously, many individual state medical boards instituted waivers around licensure requirements for out-of-state physicians when providing telehealth services during COVID; these waivers were generally tied to state public health emergency declarations.
Since 2020, DHS has reviewed and extended the federal PHE every three months. Most recently, on 7/15/22 DHS announced that it is again extending the COVID PHE until approximately 10/15/22. DHS also indicated that it would provide 60 days of formal notice before terminating the PHE; given the lack of such an announcement, expectations are that it will likely be extended again in October. Additionally, advocacy groups including the Federation of American Hospitals and the National Association of Chain Drug Stores have formally requested that HHS extend the PHE for at least another 6 months to allow facilities and providers more time to adjust to the expiration of federal waivers.
For specific legal requirements and recommendations around telehealth, see MIEC’s Telehealth Update.
For physicians, one of the most prominent changes related to the PHE is the ability to utilize telehealth to evaluate and treat patients remotely, including through the prescription of controlled substances.
Ryan Haight Act:
While many states allow physicians to establish a physician-patient relationship through telehealth for the purposes of prescribing medications, federal law imposes additional requirements for controlled substances. Before prescribing controlled substances to new patients, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 typically requires prescribers to evaluate each patient through an in-person visit before prescribing and at least every 24 months thereafter, even if a patient has already been taking the controlled substance in question.
During the PHE, the in-person evaluation requirement imposed by the Ryan Haight Act was formally waived to allow physicians to use videoconferencing to perform the required examinations initially and every 24 months when prescribing controlled substances.
This waiver has allowed medical practices to enroll new patients and treat them entirely via telehealth, including prescribing controlled substances. The overall effect has led to a 63-fold increase in telehealth visits since the pandemic, with 52.7 million Medicare telehealth encounters in 2020 alone. Many of these patients have been prescribed a controlled substance by a physician whom they have never met in person.
However, it is important to note that, once the public health emergency is over, the DEA will likely once again require in-person visits before prescribing controlled substances to new patients, and once every 24 months.
Of note, the Ryan Haight Act has some exceptions that do allow for telehealth prescribing, under the following circumstances:
- Treatment in a hospital or clinic
- Treatment in the physical presence of another provider
- Indian Health Service
- HHS public health emergency
- Special registration
- Department of Veterans Affairs medical emergency
Looking further into the requirements, the first two exceptions read as follows:
(1) Treatment in a hospital or clinic. The practice of telemedicine is being conducted while the patient is being treated by, and physically located in, a hospital or clinic registered under section 303(f) of the Act (21 U.S.C. 823(f)) by a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable State law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the State in which the patient is located, unless the practitioner:
(i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C. 822(d); or
(ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);
(2) Treatment in the physical presence of a practitioner. The practice of telemedicine is being conducted while the patient is being treated by, and in the physical presence of, a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable State law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the State in which the patient is located, unless the practitioner:
(i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C. 822(d)); or
(ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is using the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);
The references to 21 USC 823(f) refers to a law allowing the special registration for prescribing controlled substances over the internet, but it appears that this allows for a future process that has not yet been implemented by the DEA.
Physicians looking to apply one of the exceptions under the Ryan Haight Act should be aware of the overall requirement of the Act, which is that controlled substances may only be prescribed for a “legitimate medical purpose issued within the usual course of professional practice.” This is intended to create a separate requirement to meet certain standards in prescribing a controlled substance. In other words, it means that simply performing a face-to-face evaluation (whether in person or by telehealth) doesn’t necessarily demonstrate compliance with the law if the medication was otherwise not appropriately indicated. This is another reason to approach compliance by trying to stay well within the requirements of the law, rather than attempting to apply exceptions.
An October 2020 statement from the DEA puts this concept into further perspective:
“While the lack of an in-person medical evaluation has always been viewed as highly probative evidence that a prescription has been issued outside of the usual course of professional practice and for other than a legitimate medical purpose, the Act makes it unambiguous that it is a per se violation of the CSA (Controlled Substances Act) for a practitioner to issue a prescription for a controlled substance by means of the internet without having conducted at least one in-person medical evaluation, except in certain specified circumstances.
However, as Congress expressly stated under the Act, the mere fact that the prescribing practitioner conducted one in-person medical evaluation does not demonstrate that the prescription was issued for a legitimate medical purpose within the usual course of professional practice.
Even where the prescribing practitioner has complied with the requirement of at least one in-person medical evaluation, a prescription for a controlled substance must still satisfy the longstanding requirement of federal law that it must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.”
Standard of Care:
Importantly, physicians must not only practice within the bounds of federal and state law, but they must also treat patients in accordance with the applicable standard of care. During the pandemic, restricting unnecessary in-person visits was essential to controlling the spread of COVID, and standards of care adjusted to include telehealth visits as a specific COVID mitigation strategy, even in situations in which in-person care was previously required.
As the pandemic recedes and community public health measures increasingly control the spread of COVID, standards of care are adjusting back to require in-person care when appropriate. Physicians are decreasingly able to rely on COVID mitigation as the sole reason to treat patients remotely. Thus, shifting standards of care are increasingly likely to require in-person care. This effect is likely to be more significant in the setting of controlled substances, including benzodiazepines and opioids in particular. Thus, physicians should consider again requiring in-person visits for controlled substance patients, even if those who are on stable treatment regimens. Physicians with telemedicine-only practices should consider how they can implement this into their practice, or how they will transition controlled substance management to another provider.
Recommendations:
Until or unless further information comes to light or there is a change in the law, MIEC recommends that all physicians who prescribe controlled substances implement in-person visits with the prescribing physician before the first controlled substance prescription, and every 24 months while the prescription is maintained. While federal law still allows for telehealth-only visits, physicians should start preparing for the anticipated changes in the law sometime in the next year and plan with patients accordingly. Patients who are unwilling or unable to be seen physically in the office should be given adequate time to transition their care to another physician. Advance planning and careful transition of care will save physicians from potentially having to choose between inappropriate prescribing and patient abandonment.
For patients who are on a controlled substance and have never been seen in person, physicians should make sure to schedule their 24-month follow-up and consider bringing them in sooner, if practical. Additionally, physicians should be aware of any state requirements to check the prescription monitoring database (PDMP) and changing standards of care around the management of specific controlled substance medications and be sure to follow them.
For additional information or assistance, please contact MIEC’s Patient Safety & Risk Management team at patientsafetyriskmgmt@miec.com.