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More Telemedicine Food for Thought: Exception Five to the Haight Act’s In-Person Examination Requirement

In our July 10, 2017 post regarding telemedicine prescribing, we wrote about the seven exceptions to the Haight Act’s requirement that a provider and patient have an-person visit before a prescriber/practitioner can prescribe a controlled substance for his/her patient. As we concluded in the post, the current exceptions are so narrowly focused that they are of limited utility to telemedicine providers and practitioners.

Notwithstanding the foregoing, it appears that one of the seven exceptions – Exception No. 5 – may be on the cusp of relevance to the telemedicine industry and to those telemedicine practitioners who are also prescribers under state licensure laws. Exception No. 5 allows a practitioner/prescriber to prescribe medication without a prior in-person examination if the “practice of telemedicine is being conducted by a practitioner who has obtained from the Administrator a special registration under section 311(h) of the Act (21 U.S.C. 831(h)).” The exception is currently unusable, however, since the DEA has not created any such registration provisions.

Expansion of Exception 5– or the addition of new exceptions through either regulation or legislation – has the potential of making it possible – under federal law – for prescribing practitioners to obtain a DEA “special registration” and, in turn, prescribe medications to patients whose initial examinations are conducted as “virtual visits” on a telemedicine platform. Notwithstanding the foregoing, once the DEA starts issuing special registrations, there will continue to be a potential impediment to telemedicine prescribing – those state laws (usually state healthcare licensing and scope-of-practice laws) that require initial in-person examinations as precursors to the issuance of prescriptions.

As described in our July 10, 2017 post, states are taking actions such that practitioner/prescribers in such states will have the ability under state laws to take advantage of federal action that will allow the DEA to develop and implement a federal “special registration” process. However, such states are in the minority as compared to those states that require pre-prescribing in-person patient examinations.

Because of the ongoing obstacles created by state laws that prohibit telemedicine prescribing, changes in the Haight Act and/or the Haight Act’s implementing regulations will only be a “first step” on the road to telemedicine prescribing. State legislative and regulatory action on the same subject will be the “second step.” As a result, the telemedicine lobby and other stakeholders will need to continue their efforts to influence lawmaking on both the federal level and the state level if their goals of telemedicine-based prescribing will be realized.

Copyright © 2017, Sheppard Mullin Richter & Hampton LLP.

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About this Author

Ken Yood, Corporate, Healthcare, Attorney, Sheppard Mullin, law firm
Partner

Mr. Yood is a partner in the Corporate practice group in the firm's Los Angeles office.

Mr. Yood represents a wide range of healthcare providers and healthcare companies, including specialty and general acute hospitals (including local district, nonprofit and for-profit facilities), home health agencies, pharmaceutical vendors, nursing facilities, and health information and management providers.

310-228-3708
Associate

Ms. Kraus focuses her practice on representing healthcare entities in regulatory compliance matters.  Ms. Kraus advises clients on compliance with federal and state fraud and abuse laws, assists clients in responding to government investigations, and represents clients in False Claims Act litigation.  Ms. Kraus also assists clients with regulatory due diligence in transactional matters, and through advocacy with federal and state regulators, and leverages her background in health policy to help clients maximize opportunities in the changing healthcare landscape.  Representative matters include:

  • Drafting and submitting self-disclosures through CMS’ Self-Referral Disclosure Protocol
  • Assisting in internal investigations of reported potential regulatory non-compliance
  • Responding to government Civil Investigative Demands
  • Representing defendants in False Claims Act litigation
  • Advising clients on compliance with the Civil Monetary Penalties Law and Anti-Kickback Statute
  • Preparing filings with the Provider Reimbursement Review Board
  • Advising clients on the potential impact of MACRA implementatio
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