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Proposed Rule Seeks to Increase Access to Treatment for Opioid and Heroin Abuse

In a continuation of the Federal government’s focus on the opioid and heroin epidemic, President Barack Obama announced last week that the United States Department of Health and Human Services (HHS) has issued a proposed rule intended to increase the number of patients a qualified physician may treat using Buprenorphine for opioid and heroin addiction.i If implemented, the change would increase access to medication-assisted treatment and behavioral health support for the tens of thousands of people currently suffering from opioid use disorders but unable to gain access to treatment providers. As such, the proposed rule was quickly praised by the American Society of Addiction Medicine, who has long-advocated raising or eliminating the patient limitation for Buprenorphine prescribers. 

Currently, in order to use Buprenorphine products for the purpose of treating opioid and heroin addiction, a physician must apply and qualify for a special registration under the Drug Addiction Treatment Act of 2000 (see 21 U.S.C. 823(g)). An approved physician is then provided with a unique registration number that must be included on every prescription. Under the current Federal law, an approved physician cannot treat more than 100 patients for opioid maintenance treatment and must attest that he or she has the capacity to refer addiction treatment patients for appropriate counseling and other non-pharmacologic therapies. 

The common Buprenorphine products of Suboxone or Subutex – combinations of Buprenorphine and Naloxone – are available in tablet and film formulations that require self-administration by patients on a daily basis. Both medications work to eradicate the influence opioids have on the brain, and allow those dependent upon opioids and heroin to stop taking drugs without experiencing painful withdrawal symptoms or struggling with drug cravings. Additionally, the U.S. Food and Drug Administration is reviewing a product named Probuphine, an investigational subdermal implant designed to deliver Buprenorphine continuously for six months following a single treatment. Conceivably, such Buprenorphine product could promote greater levels of patient compliance and retention with treatment programs. 

The proposed rule from HHS seeks to increase the limitation placed on appropriately trained and qualified physicians from 100 patients to 200 patients, thereby increasing a physician’s ability to incorporate such treatment modality into their practice. While still only a proposal at this point, President Obama’s comments indicate considerable support by the executive branch to facilitate greater access to drug treatment. The Substance Abuse and Mental Health Services Administration is accepting official comments from the public through May 31, 2016. 

See Medication Assisted Treatment for Opioid Use Disorders, 81 Fed. Reg. 17,639 (March 30, 2016) (to be codified at 42 C.F.R. pt. 8).

© 2020 Dinsmore & Shohl LLP. All rights reserved.National Law Review, Volume VI, Number 95


About this Author

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

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...

Daniel S. Zinsmaster, Dinsmore Law Firm, Health Care Lawyer

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

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