Category: prescription drugs

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Telemedicine Prescribing and Controlled Substances Laws

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Editor’s Note: This article is the first of a series addressing telemedicine prescribing and controlled substances, designed to give some much needed practical guidance and orientation to established health care providers, hospitals, and entrepreneurs alike.

As providers become more comfortable with delivering care via telemedicine, telehealth, and digital health technologies, some are exploring services beyond low acuity consults.  One area of opportunity – and notable confusion – is prescribing controlled substances via telemedicine.  This particularly affects specialties that couple chronic disease management with pharmacotherapy.  For example, adolescent and adult telepsychiatry, substance abuse/recovery, endocrinology, hormone replacement therapy, and medical weight loss.

Providers are increasingly inquiring about telemedicine prescribing laws and rules, as well as strategies and approaches for business models and service lines that not only satisfy patient needs, but comply with the layers of intersecting state and federal laws on telemedicine, medical practice, fraud and abuse, and controlled substances.  Indeed, telemedicine prescribing of controlled substances was one of the “Telehealth Top 10” for 2015, and has only continued to generate interest since that time.

What is the Federal Ryan Haight Act?

The Ryan Haight Online Pharmacy Consumer Protection Act was designed to combat the rogue internet pharmacies that proliferated in the late 1990s, selling controlled substances online.  The Act took effect April 13, 2009 and the Drug Enforcement Agency (DEA) issued regulations effective that same date.  The Act essentially imposed a federal prohibition on form-only online prescribing for controlled substances.  Although the Act was intended to target “rogue” internet pharmacies, legitimate healthcare providers who prescribe controlled substances via telemedicine must carefully review the regulations to ensure compliance.

What Does the Ryan Haight Act Mean for Healthcare Professionals?

Under the Ryan Haight Act, no controlled substance may be delivered, distributed, or dispensed by means of the internet (which, for all practical purposes, includes telemedicine technologies) without a valid prescription.  A valid prescription is one that is issued for a legitimate medical purpose in the usual course of professional practice by: 1) a practitioner who has conducted at least one in-person medical evaluation of the patient; or 2) a covering practitioner.  An “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the prescribing practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.

While the DEA has historically viewed the lack of an in-person medical evaluation as a red flag of potential drug diversion, the Ryan Haight Act makes it unambiguous that it is a per se violation of the federal 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.  Once the prescribing practitioner has conducted an in-person medical evaluation, the Ryan Haight Act does not set an expiration period or a mandatory requirement of subsequent annual re-examinations (although specific controlled substances, such as suboxone, may have their own rules).  Of course, this does not mean that conducting one in-person medical evaluation is sufficient in every clinical situation.  Even where the practitioner has conducted an in-person exam, a prescription for a controlled substance must still be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice.

Can a Health Care Provider Prescribe Controlled Substances via Telemedicine?

The Ryan Haight Act does not prohibit the use of telemedicine to prescribe controlled substances, and a provider may do so if federal and state requirements are met.  However, the challenge for many providers is understanding these laws and applying them to the processes of their specific service line or business.  There are solutions and approaches that can work for primary care practices, hospitals, telepsychiatry groups, and the like.  Moreover, the Ryan Haight Act has seven exceptions to the in-person medical evaluation requirement for when a prescriber is engaged in the practice of telemedicine.  For DEA purposes, keep in mind that “practice of telemedicine” is a defined term of art, and the exceptions are technical and specific.  Providers should not assume their approach to telemedicine or virtual care does, in fact, meet a “practice of telemedicine” exception under the Ryan Haight Act.  The next articles will discuss the practice of telemedicine exceptions under the Ryan Haight Act, as well as state laws.

What’s Next for the Ryan Haight Act?

In 2015, the American Telemedicine Association sent a letter to the DEA, advocating for provider-friendly changes to federal controlled substance prescribing rules.  Disclosure: attorneys in Foley’s telemedicine practice were contributing authors to the letter.  The letter urged DEA to open a special registration process allowing psychiatrists and physicians to prescribe controlled substances via telemedicine without the need for an in-person exam.  The ATA letter noted that “the interpretation of the [Ryan Haight] Act’s general prohibition of prescribing controlled substances by means of the internet has become overly restrictive.”

In 2016, DEA announced plans to issue a new rule to activate the special registration process allowing physicians to use telemedicine to prescribe controlled substances without an in-person exam.  The most recent notice of rulemaking stated the proposed rule was expected to be published in January 2017.  As of this article, the proposed rule has not yet been released, but is anticipated to be published this year.

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Virtual Care practice.

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Ohio Telemedicine Prescribing and Controlled Substances Laws

Ohio

The Ohio Medical Board just last week adopted new rules for telemedicine prescribing of drugs and controlled substances, allowing providers to prescribe drugs via telemedicine without conducting an in-person examination.  Effective March 23, 2017, the new rule 4731-11-09 and rule 7331-11-01 set forth the requirements a physician must follow when prescribing via telemedicine in Ohio.

Prescribing Drugs via Telemedicine

An Ohio physician may prescribe non-controlled substances via telemedicine, without an in-person exam, if the physician satisfies the following nine requirements:

  • Establishes the patient’s identity and physical location;
  • Obtains the patient’s informed consent for treatment through remote examination;
  • Requests the patient’s consent and, if granted, forwards the medical record to the patient’s primary care provider or other health care provider, if applicable, or refers the patient to an appropriate health care provider or health care facility;
  • Completes a medical evaluation through interaction with the patient that meets the minimal standards of care appropriate to the condition for which the patient presents;
  • Establishes a diagnosis and treatment plan, including documentation of necessity for the utilization of a prescription drug, including contraindications to the recommended treatment;
  • Documents in the medical record the care provided, patient’s consent, medical information, and any referrals made to other providers;
  • Provides appropriate follow-up care or recommends follow-up care;
  • Makes the medical record of the visit available to the patient; and
  • Uses appropriate technology sufficient for the physician to conduct the above as if the medical evaluation occurred during an in-person visit.

Prescribing Controlled Substances via Telemedicine

An Ohio physician may prescribe controlled substances via telemedicine, without an in-person exam, if the physician satisfies the nine steps outlined above and when one of the following six situations exists:

  • The patient is an “active patient” of a health care provider who is a colleague of the physician and the controlled substances are provided through an on call or cross coverage arrangement between the health care providers. “Active patient” is a defined term under the new rules and means that “within the previous twenty-four months the physician or other health care provider acting within the scope of their professional license conducted at least one in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine as that term is defined in 21 C.F.R. 1300.04, in effect as of the effective date of this rule.”
  • The patient is located in a DEA-registered hospital or clinic;
  • The patient is being treated by, and in the physical presence of, an Ohio-licensed physician or health care practitioner registered with the DEA;
  • The telemedicine consult is conducted by a practitioner who has obtained a DEA special registration for telemedicine;
  • A hospice program physician prescribes the controlled substance to a hospice program patient in accordance with the board of pharmacy rules; or
  • The physician is the medical director of, or attending physician at, an “institutional facility” (defined in rule 4729-17-01) and 1) the controlled substance is being provided to a person who has been admitted as an inpatient to or is a resident of an institutional facility, and 2) the prescription is transmitted to the pharmacy by a means that is compliant with Ohio board of pharmacy rules.

The above six situations largely mirror exceptions under the federal Ryan Haight Act.  Telemedicine advocates have noted the Ryan Haight Act’s rules on prescribing controlled substances have hindered contemporary, legitimate telemedicine practices.  Members of the American Telemedicine Association have advocated for provider-friendly changes, and the DEA is expected to issue new rules this year, opening a special telemedicine registration for prescribers.

The Buckeye State now joins others (e.g., Delaware, Florida, New Hampshire, and West Virginia) that have carved out express exceptions to allow for telemedicine prescribing of controlled substances.  This is encouraging news for providers using telemedicine in their practice, as controlled substances are an important and clinically significant component of certain specialties, including telepsychiatry and hospitalists/emergency medicine.

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Virtual Care practice.

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