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Indiana Reverses Course on Telemedicine Prescribing and Controlled Substances Laws

Indiana has taken another step towards expanding the meaningful use of telemedicine in connection with clinical services and prescribing. HB 1337, signed by Governor Eric Holcomb and effective July 1, 2017, will allow providers to prescribe controlled substances via telemedicine without an in-person examination, albeit with some notable limitations and restrictions. The law reverses Indiana’s 2016 telehealth law that prevented providers from prescribing controlled substances via telehealth technologies.

Prescribing Drugs via Telemedicine

Under the new law an Indiana provider may prescribe non-controlled substances via telemedicine, without an in-person exam, if the following conditions are met:

  • The provider has satisfied the applicable standard of care in the treatment of the patient.
  • The issuance of the prescription by the provider is within the provider’s scope of practice and certification.
  • The prescription is not for a controlled substance.
  • The prescription is not for an abortion inducing drug.
  • The prescription is not for an ophthalmic device, including: (1) glasses; (2) contact lenses; or (3) low vision devices.

Prescribing Controlled Substances via Telemedicine

Under the new law an Indiana provider may prescribe controlled substances via telemedicine, without an in-person exam, if the prescriber satisfies the conditions outlined above and the following conditions are met:

  • The prescription is not for an opioid, unless the opioid is a partial antagonist that is used to treat or manage opioid dependence.
  • The prescriber maintains a valid controlled substance registration.
  • The prescriber meets the conditions set forth in the federal Ryan Haight Act.
  • The patient has been examined in-person by a licensed Indiana health care provider and the licensed health care provider has established a treatment plan to assist the prescriber in the diagnosis of the patient.
  • The prescriber has reviewed and approved that treatment plan and is prescribing for the patient pursuant to that treatment plan.
  • The prescriber complies with Indiana’s INSPECT prescription drug monitoring program.
  • The prescription for a controlled substance is prescribed and dispensed in accordance with Indiana Code 35-48-7.

While Indiana’s new law removes its prior blanket ban on telemedicine prescribing of controlled substances, it still requires the patient to undergo an in-person exam conducted by an Indiana health care provider, although not necessarily by the prescriber herself. This renders Indiana law more restrictive than many states, and even more restrictive than the federal Ryan Haight Act. The new law follows a growing trend among states to amend and eliminate prior statutory prohibitions on telemedicine prescribing of controlled substances. Michigan, for example, recently enacted a law to eliminate its previous ban, and now allows health professionals to prescribe controlled substances via telemedicine without an in-person examination.

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, endocrinology, and hospitalists/emergency medicine.

Telemedicine prescribers should continue to be mindful of prescribing requirements under federal laws, as remote prescribing of controlled substances is governed by the Ryan Haight Act. Providers must understand and navigate many intersecting state and federal laws on telemedicine, medical practice, fraud and abuse, and controlled substances.

© 2017 American Health Lawyers Association. Washington, DC. Reprinted with permission.

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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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