On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”) came into law as the federal government’s first attempt to address the public health risks associated with online pharmacies – such risks including the dispensing of drugs (including addictive drugs to be used recreationally) without a valid prescription, and the dispensing of adulterated drugs, counterfeit drugs, and/or expired drugs, all of which could result in significant harm to individuals who may have been looking for an easy way to obtain prescribed medications at a lower price.
The Haight Act’s weapons of choice against risks of questionable online pharmacy practices include (i) a requirement that online pharmacies can only dispense medications after receipt of a written prescription from the ordering patient’s treating physician; and (ii) a requirement that prescriptions can only be written by a physician after an in-person patient examination.
Although the Haight Act, as the first federal online pharmacy law, was generally considered a good first step to reign in dangerous practices associated with online pharmacies, changes in healthcare policy and priorities, and the advancement of healthcare technology since 2008, have resulted in a growing realization that the online prescribing hurdles raised by the Haight Act in 2008 require much-needed adjustment.
The Haight Act: An Origin Story
The dangers of Internet pharmacies were making headlines well before the Haight Act was introduced in the Senate on March 23, 2007. As noted above, the dangerous practices of Internet pharmacies that have grabbed, and continue to grab, the public’s attention include the easy online availability of prescription drugs, including opioids, with no prescriptions required. To address the prescription issue without making it harder for consumers to access drugs, some online pharmacies made customers complete online health questionnaires to be reviewed by a physician or other medical practitioner as part of the drug ordering process. The questionnaires were intended to be a quick, efficient, and customer-friendly substitute for an in-person medical examination by a treating physician who, at the end of the exam, still might not prescribe medication.
In practice, the questionnaires were no substitute for an actual medical exam and prescription. Completed questionnaires were usually approved without any communication between prescriber and customer and there certainly was no interaction that remotely resembled the provision of healthcare. Thus, online pharmacies became known for what they often were: an easy way to get prescription medications, including medications that were frequently used on a recreational basis, without the hassles of getting a legitimate prescription from a healthcare professional.
In response to abuses like the above, the Haight Act was written to sharply limit the ability of healthcare practitioners to prescribe controlled substances to patients without a prior in-person medical examination. For example, the Haight Act amended Section 309 of the Controlled Substances Act (21 U.S.C. §829) to include the following excerpted language:
(e) CONTROLLED SUBSTANCES DISPENSED BY MEANS OF THE INTERNET. —
(1) No controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.
(2) As used in this subsection:
(A) The term ‘valid prescription’ means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by—
(i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or
(ii) a covering practitioner.
(B)(i) The term ‘in-person medical evaluation’ means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals….
Notwithstanding the above language that seems to make “in-person medical evaluations” an unavoidable necessity, the Haight Act also includes seven exceptions that allow telemedicine providers to prescribe medications without having to meet with the patient in-person. Unfortunately, given the narrow application of these exceptions, the exceptions have not alleviated the burdens of the Haight Act on the further development and expansion of telemedicine. For example, two of the exceptions only apply to emergency medical care, and two other exceptions require that the patient being seen by a telemedicine provider be in the physical presence of a provider or practitioner registered with the Drug Enforcement Administration (“DEA”). A fifth exception applies to circumstances established by regulation. As of the date of this writing, there are no circumstances established by regulation.
In summary, the narrowness of the exceptions for telemedicine has generally left telemedicine providers without the ability to prescribe controlled substances for their patients. Therefore, telemedicine supporters maintain that the Haight Act’s in-person encounter requirements have negatively affected the potential usefulness of the telemedicine medium for patients who may have difficulty reaching a practitioner’s physical location.
The Haight Act: Outliving its Usefulness?
Because of post-1998 developments in communication and other technology, the telemedicine industry and its practitioners maintain that telemedicine allows patients and remotely-located physicians to rely on virtual medical visits that are substantially equivalent to an in-person physician/patient encounter and bear little to no relationship to the pre-Haight Act online questionnaire-based pharmacy model. Current technology allows a physician to both (i) hear patient responses to questions about medical history, present illness, and other routine components of a traditional in-person physician/patient examination, and (ii) make visual observations regarding a patient’s physical condition through the video and imaging features embedded within a telemedicine system’s hardware and software components. As can be expected, the telemedicine industry and practitioners are very vocal about their shared belief that telemedicine technology has successfully addressed Haight Act concerns about distant physicians who prescribe medications to unseen patients with whom they have no real contact and no legitimate doctor/patient relationship.
Notwithstanding the acknowledged advances in current telemedicine technology, the Haight Act has left many telemedicine providers without the ability to prescribe controlled substances that meet patients’ medical needs as directly observed during medical examinations conducted remotely on a telemedicine platform. New rules, expected to be promulgated later this year by the DEA, may help to mitigate this challenge. Likewise, many states, reacting to the expanding relevance of telemedicine, are relaxing rules that similarly limited telemedicine prescribing. Practitioners who engage in telemedicine should closely follow these developments, which may have a critical impact on the permissible scope of their practice.
Potential for New Federal Rulemaking
Recognizing the expanded reach of and interest in telemedicine, and that the limited Haight Act exceptions for telemedicine have not kept up, the DEA announced in 2016 that it will promulgate regulations to establish a special telemedicine registration process contemplated by the Haight Act, potentially allowing a broad range of practitioners to provide telemedicine services that include controlled substances prescriptions without a preliminary in-person evaluation. Such a change could be a tremendous boon to patients whose location or medical condition makes traveling for in-person visits difficult, while continuing to restrict unscrupulous pharmacies and practitioners from engaging in medically inappropriate prescribing via the Internet. However, the new rule, which the DEA originally expected to publish in January 2017, has not yet been released.
Relaxation of State Laws
State law may also pose an impediment to telemedicine practitioners seeking to prescribe controlled substances needed by their patients. However, several states, whether through new laws or through medical board rules, have moved in the direction of loosening these restrictions, and thereby expanding the opportunity for practitioners to offer more comprehensive care to their patients via telemedicine.
Indiana. Indiana recently amended its telemedicine law that had previously prohibited providers from prescribing controlled substances via telemedicine technology. Under the new law, HB 1337, effective as of July 1, 2017, providers may prescribe certain controlled substances via telemedicine, although only under limited circumstances, including that the patient has been examined in-person by a licensed Indiana healthcare provider who has established a treatment plan that will assist the telemedicine prescriber in diagnosing the patient.
Michigan. Recently enacted SB 213 amends a 2016 statute that prohibited providers from prescribing controlled substances via telemedicine. Michigan’s new law provides greater leeway for telemedicine prescribing of controlled substances than does the Indiana law, as no in-person visit with a licensed provider is required. Instead of an in-person visit, SB 213 requires that Michigan prescribers act within their licensed scope of practice, meet applicable requirements for prescribing a controlled substance (including those of the Haight Act), provide patients with referrals for other services if medically necessary, and make him or herself available for follow-up care or refer the patient to another practitioner for follow-up care.
Ohio. This year, the Ohio Medical Board promulgated new rules, O.A.C 4731-11-09 and 7331-11-01, for telemedicine prescribing of controlled substances. These rules require prescribers to follow a series of steps to prescribe any drug via telemedicine. Such steps include obtaining identifying patient information (e.g., the patient’s physical location), completing an online medical evaluation meeting minimum standards of care, and providing or recommending follow-up care as needed. To prescribe a controlled substance, the prescriber must also fall within one of six situations, like the Haight Act exceptions described above.
Florida. In 2016, the Florida Board of Medicine amended its rules on telemedicine prescribing by implementing Rule 64B8-9.0141, F.A.C. Previously, the Board had banned any prescription of controlled substances using telemedicine; the new rule allows telemedicine prescribing except in the case of controlled substances prescribed for the treatment of psychiatric disorders.
Delaware and West Virginia. Some other states have already addressed controlled substance prescribing through more comprehensive telemedicine laws. In 2015, Delaware adopted a telemedicine law (HB 69) that allows prescribing of controlled substances via telemedicine after a valid physician-patient relationship is established; no in-person visit is required to establish this relationship. West Virginia adopted a telemedicine law in 2016 (HB 4463) that allows for telemedicine prescribing of certain controlled substances without an in-person exam if certain conditions are met.
This growing trend to expand the circumstances under which practitioners can prescribe controlled substances needed by their patients will continue to increase the permissible scope, and therefore usefulness, of telemedicine services. Particularly in combination with potential new Haight Act rules, these changes at the state level may have an important impact on the care that telemedicine practitioners can offer their patients. Practitioners should devote careful attention to potential developments, at both the state and federal levels, over the next few years.