Tele-psychiatry and the Ryan Haight Online Pharmacy Consumer Protection Act. June 8, 2015 Libby Baney, Senior Director, FaegreBD Consulting

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1 Tele-psychiatry and the Ryan Haight Online Pharmacy Consumer Protection Act June 8, 2015 Libby Baney, Senior Director, FaegreBD Consulting

2 Tele-psychiatry and the Ryan Haight Online Pharmacy Consumer Protection Act Background The Issue Recommendation Next steps 2

3 Background: What is Telehealth (aka telemedicine, m-health, e-health)? The use of electronic information and telecommunications technologies to support remote clinical health care, patient and professional health-related education, public health activities, and health administration. Telehealth involves real-time, synchronous audio-video encounters between patients and providers

4 Background An independent research firm recently estimated the 2014 worldwide telemedicine, m-health, and tele-health markets at $1.5 billion, and predicts explosive growth to $45.4 billion within seven years. Tele-psychiatry is a thriving area of telemedicine. Indeed, one million telepsychiatry consultations are estimated to occur in the U.S. in 2015 according to an executive with InSight Telepsychiatry. Benefits of tele-psychiatry include: Increased access to medical specialists Mitigating provider shortages Convenience for patients and doctors Cost savings (from reduced ER visits) Increased efficiency 4

5 The Issue Issue: Psychiatrists have been prohibited from issuing a prescription for a controlled substance by means of the Internet (via telemedicine) by the US Drug Enforcement Agency, finding such violates the Ryan Haight Online Pharmacy Consumer Protection Act ( Ryan Haight Act ). Among other things, the Act requires that no controlled substance may be delivered, distributed or dispensed by means of the Internet without a valid prescription. Unless a telemedicine exception applies, a valid prescription may only be obtained (1) by a practitioner who has conducted at least one in-person medical evaluation of the patient, or (2) by a covering practitioner. The Act provides for seven (7) exceptions, including the most common exception for when the patient is located at a facility registered with the DEA and is being treated by a DEA-registered provider. But none of these apply here 5

6 The Issue Facts: Real Life Example Patient A is at a mental health clinic that is not registered with the DEA. Patient A is in the physical presence of a mental health worker, but is not in the physical presence of a DEA registered provider. Psychiatrist B is registered with DEA and treats the patient via telemedicine. Physiatrist B s treatment includes a prescription for a controlled substance. DEA finds that this issuance of a prescription via telemedicine violates the Ryan Haight Act. Question: What should be done to allow psychiatrists to prescribe controlled substances via telemedicine to patients in this circumstance, without creating a loophole in the law that may be exploited by unscrupulous actors? 6

7 What Can We Do About This? Overview of the Options Ask DEA to create a new a regulatory exception Lobby Congress to change the statute

8 Recommendation Ask DEA to use their authority under the Act to create a new exception, by regulation, to the in-person medical evaluation requirement: DEA could require facilities that are not otherwise registered with DEA (like mental health clinics), but who nonetheless have the need to engage in telemedicine involving prescriptions for controlled substances to register as a DEA telemedicine site 8

9 Recommendation Considerations: Does not require Congress to act; DEA may solve the problem by regulation. Gives DEA transparency into the business practices of clinics/facilities not registered with the DEA under section 303(f) but who nonetheless desire to engage in the practice of telemedicine involving controlled substances. Gives DEA jurisdiction over the clinics/entities for violation of the Ryan Haight Act should the clinic/facility fail to comply with the requirements of the new, proposed exception. Enables facilitates to attract DEA registered providers to work with them, as the provider no longer faces the risk of being investigated under the Ryan Haight Act. Preserves the purpose of the Act, avoids creating a legal loophole that could be abused by pill mills, unscrupulous doctors and illegal online drug sellers. 9

10 Question for the Group Should NCBH engage on this issue? If so, should NCBH pursue the proposed approach?

11 Discussion/Questions 11

12 Thanks! Libby Baney, JD Senior Director, FaegreBD Consulting Counsel, Faegre Baker Daniels P:

13 Appendix A Other Approaches Considered 13

14 Appendix A Other Approaches Considered Exception for Community Mental Health Clinic/Facilities. Craft an exception that only applies to prescriptions issued by (a) DEA registered provider who is (b) affiliated with a licensed mental health clinic or facility that (c) is not registered with the DEA and does not dispense controlled substances. As proposed, elements (a) through (c) all must exist in order for the exception to apply. Requiring providers to be affiliated with a licensed clinic of facility helps guard against individual practitioners advertising telemedicine services (i.e. online prescription mills) for controlled substances directly to consumers, but it may be difficult to define and apply the affiliated with standard Requiring the facility or clinic to be licensed gives law enforcement another compliance hook, whereby state or federal officials could shut-down an unlicensed clinic and/or sanction any provider engaging in online prescribing of controlled substances without affiliation with a licensed clinic/facility; Limiting the exception to clinics/facilities that are not registered with DEA and does not dispense controlled substances further prevents against possible abuses, as the clinics/facilities would not have a financial interest in the volume of controlled substance prescriptions issued. Should this approach be pursued, it would be important to understand the possible nature of the relationship between providers and clinics/facilities so that the term affiliated with a state licensed mental health clinic or facility may be defined for purposes of the exception without cutting off access to legitimate medical services. More research would be needed on this point. 14

15 Appendix A Other Approaches Considered Exception for activity consistent with state law/regulation. Under this approach, prescribing for controlled substances could be done via telemedicine so long as the activity is consistent with state laws and regulations. This raises a few issues: State laws vary widely on the issue of telemedicine standards. Currently there is no uniform national standard for telemedicine activities and online prescribing. E.g. Minnesota vs. Alabama/Texas. Deferring to state laws/regulations is risky as state laws are in flux, and inefficient, as such would not yield a consistent standard for tele-psychiatry nationwide. Members of Congress, may oppose an exception that defers to state laws, as state laws could lead to lower standards for the prescribing and dispensing of controlled substances than intended by the Ryan Haight Act. This would also give rise to forum- shopping by unscrupulous actors to avoid restrictive prescribing and dispensing laws. Further, without the threat of federal enforcement under the Ryan Haight Act, bad actors may be more willing to take the risk of violating state medical board laws and regulations related to online prescribing and dispensing. This potential for abuse could raise concern by stakeholders including e.g. federal authorities and policymakers, state regulatory organizations, drug abuse and diversion organizations, pharmacy groups, and safe medicines advocates. 15

16 Appendix A Other Approaches Considered Statutory Change. Advocate for Congress to add a new clause at USC 829(e)(2)(A)(i) that defines in-person medical evaluation as being inclusive of a videoconference evaluation conducted via telemedicine by a properly registered practitioner with their patient. There are a few issues to consider here: Statutory change is a heavier lift than seeking a regulatory exception. The plain language, legislative history and implementing regulations of the Act indicate that Congress intended for in-person medical evaluation to require physical presence so that the practitioner could fully assess the physical and mental health of the patient. Opponents may argue that an in-person patient medical evaluation creates a checkpoint for patients seeking controlled substances. Plus, consumers seeking controlled substances for recreation, not medical, purposes are less likely to go see a doctor in-person verses their willingness to go online and video chat with a doctor. We do not know what FSMB and AMA would think about revising the Act to allow providers to issue a prescription for a controlled substance without a prior physical medical evaluation. Recent FSMB and AMA model telemedicine policies were issued after the enactment of the Ryan Haight Act, and both require compliance with other applicable state and federal laws (including the Ryan Haight Act). 16