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Unintended Consequences of Ohio's S.B. 319 Could Reduce Access to Addiction Treatment

In the midst of an acknowledged opioid epidemic and public health crisis for treatment resources and options, the Ohio General Assembly has approved Senate Bill 319 (S.B. 319) which contains provisions which are expected to aid in the response to this crisis. However, one provision of this new law will in all likelihood reduce access to Suboxone clinics operating in the State of Ohio. S.B. 319 does this by establishing State of Ohio Board of Pharmacy (Pharmacy Board) licensure requirements for locations providing Suboxone treatment to patients suffering from opioid and heroin abuse and dependence even if such locations do not store, possess, or distribute any medications. S.B. 319 is awaiting Governor Kasich’s signature.

The Pharmacy Board’s Suboxone licensure requirements from S.B. 319 are substantive and comparable to those adopted for pain management clinics in 2011 from House Bill 93. Consequently, it is anticipated that many Suboxone facilities currently in operation will encounter difficulty meeting these licensure requirements, and may no longer be able to continue operation.

These new Ohio standards, which will likely decrease access to Suboxone treatment, appear to run contrary to the trend at the federal level. There, recent legal changes have focused on increasing access to Suboxone treatment, as demonstrated by the passage of the Comprehensive Addiction and Recovery Act in July 2016, and recent regulation by the U.S. Department of Health and Human Services which, among other things, increased the patient limit for certain qualified physicians who have received special DEA registrations under the Drug Addiction Treatment Act of 2000.

Among the new Ohio licensure requirements, S.B. 319 limits who may own or operate a location providing Suboxone treatment, imposes Pharmacy Board documentation and disclosure requirements, and establishes employment standards and restrictions similar to the pain management clinic regulations. Additionally, the new law grants the Pharmacy Board rule-making authority to adopt regulations which may create additional regulatory barriers for Suboxone providers. Operation of a Suboxone clinic (meaning a location which has more than 30 patients receiving such medication) without such license or in violation of the requirements may subject such persons to fines of up to $5,000 per each day of violation from the Pharmacy Board, professional license sanction and exposure to criminal penalties.

Significantly, S.B. 319 does contain exemptions from its licensure requirements which may lessen any unintended negative impact on access to treatment for locations that are:

  • Owned or operated, in whole or in part, by a hospital;

  • Accredited facilities that only conduct clinical research and use controlled substances in such studies;

  • Opioid treatment program that are already subject to certification by the U.S. Substance and Mental Health Services Administration (SAMHSA) and licensed by the Pharmacy Board as terminal distributors; or

  • Programs or facilities that are licensed or certified by the Ohio Department of Mental Health and Addiction Services.

While S.B. 319 contains provisions which will undoubtedly aid in Ohio’s fight against the opioid epidemic, the new Suboxone licensure requirements raise concern of unintended consequences in that the number of Suboxone facilities may be reduced.  If that happens, patients will have fewer treatment options, continuity of care or treatment itself will be interrupted or terminated and patient care may be compromised at a critical time

© 2019 Dinsmore & Shohl LLP. All rights reserved.

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About this Author

Eric J. Plinke, Dinsmore Law, Health Care Lawyer, Corporate Attorney
Partner

Eric Plinke is a Partner in the Corporate Department and Health Law Practice Group, and he routinely advises corporate and individual clients regarding a wide-range of health care industry legal issues. He has counseled clients in practice formation and acquisition, hospital and joint venture transactions, hospital and medical practice affiliations, contract review and preparation, compliance programs, HIPAA regulations, scope of practice issues, telemedicine and Stark law and Anti-kickback statutes, as well as significant experience counseling in ambulatory surgery centers and other joint...

614-227-4213
Daniel S. Zinsmaster, Dinsmore Law Firm, Health Care Lawyer
Partner

Dan provides trusted counsel and advocacy to health care clients on a variety of matters, such as corporate compliance, provider credentialing, administrative proceedings and litigation.  He also advises clients on practice formation and acquisition, as well as contract review and preparation.  In recent years, Dan has helped health care companies and providers navigate through fraud and abuse investigations, antitrust reviews, and other white collar criminal matters.  He is a frequent author and lecturer on telehealth and telemedicine issues.

Prior to joining Dinsmore, Dan practiced for nearly seven years with the State Medical Board of Ohio, where he advised board members and agency personnel on issues related to the Medical Practices Act of Ohio, Chapter 119 Administrative Procedures, and federal rules and regulations implicating the area of health care.  His substantial regulatory experience enables him to bring a unique and insightful perspective to handling diverse and complex health care matters, and his thorough understanding of health care laws and policies helps him serve as a valuable resource to corporations, health care associations, hospitals, medical practices and individual practitioners. 

In addition to his experience with federal and state health care regulatory agencies, Dan has successfully aided clients appearing before a number of other administrative or executive entities, including the Ohio Department of Commerce, Accountancy Board of Ohio, and the Ohio Board of Registration for Professional Engineers and Surveyors.  He previously served as an extern for the Legal Office of the Ohio governor, as well as the Business & Regulations Division of the Columbus city attorney’s office.

(614) 628-6949
Sarah C. Persinger PharmD RPh, managed care lawyer & pharmacy benefits management attorney at Dinsmore Law Firm
Associate

Sarah is a member of our Health Care Practice Group. She holds a Doctor of Pharmacy degree and is a registered pharmacist with extensive pharmacy practice experience and a working knowledge of regulatory affairs. She has managed health system pharmacy compliance with Ohio State Board of Pharmacy, DEA, and CMS regulations, the federal 340B Drug Discount Program, USP 797 and FDA Sterile Compounding requirements, and Joint Commission and HFAP Accreditation standards. 

Sarah has a strong working knowledge of specialty pharmacy, managed care and...

(614) 628-6979