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April 21, 2014

Final Medical Marijuana Regulations Approved in Massachusetts

The Massachusetts Department of Public Health Public Health Council approved, by unanimous vote, final regulations for the implementation of the medical marijuana ballot initiative law that will allow qualifying patients with certain medical conditions to obtain and use marijuana for medicinal purposes. Approved on May 8, the final regulations provide an implementation framework for the new law and, among other things:

  • define debilitating medical conditions for which the use of medical marijuana is authorized;
  • define the maximum 60-day supply that a patient may legally posses (10 ounces of finished leaf product);
  • define the bone fide physician patient relationship required for a physician to certify a patient for medical marijuana use.  The regulations also prohibit a physician from certifying immediate family members;
  • adopt a framework for municipal involvement and oversight in regulating medical marijuana, provided that local regulations do not conflict with state law; and
  • revise the requirement that Registered Marijuana Dispensary (RMD) applicants maintain $500,000 in an escrow account to demonstrate financial viability and instead require applicants to demonstrate at least $500,000 of liquid capital available for the first RMD location, and $400,000 for additional locations under common ownership.

Although “Medical Marijuana Treatment Center” (MMTC) was the term given to these entities under the law, the Council amended the regulatory definitions to provide that MMTCs will be known as “Registered Marijuana Dispensaries” or “RMDs.”  The Council believes that this better reflects the nature of the activities taking place at these locations, which do not provide on site clinical treatment services.

The final regulations also provide that they shall not be construed to limit the scope of practice of a nurse practitioner pursuant to M.G.L. c. 112, s. 80I.  Added by Chapter 224 of the Acts of 2012 (effective November 4, 2012), Section 80I provides that, when a law or rule requires a certification by a physician, when relating to physical or mental health, that requirement may be fulfilled by a nurse practitioner.  However, Section 80I also states that it is not to be construed to expand the scope of practice of nurse practitioners. At its May 8 meeting, at least one Public Health Council member noted that the regulations, which also require that a physician have a bona fide physician patient relationship to certify that a patient qualifies to obtain marijuana for medical use, seemed unclear as to whether or not nurse practitioners can provide this certification.  DPH staff responded that its intent is to leave it to the Board of Registration in Nursing, which licenses nurse practitioners, to determine if certifying patients for medical marijuana registration is within a nurse practitioner’s scope of practice.  DPH expects the Board will take up this issue quickly.

Despite the passage of final regulations, it will be several months before RMDs are open in the state.  Meanwhile, additional information, including Medical Marijuana FAQs, and the Department of Public Health Medical Marijuana Working Group’s Memorandum to the Public Health Council can be found at the Executive Office of Health and Human Services Medical Marijuana Page.

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About the Author

Dianne J. Bourque, Health Care Attorney, Mintz Levin Law Firm
Of Counsel

Dianne advises a variety of health care clients on a broad range of issues, including licensure, regulatory, contractual, and risk management matters, and patient care. A large part of her practice involves counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research, including patient consent, access to and use of tissue and associated patient information, and the Institutional Review Board process.

She also counsels health care clients and other business entities on the requirements of the HIPAA Privacy Rule and Security Standards,...

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About the Author

M. Daria Niewenhous, Health Care, Attorney, Mintz Levin, Law firm
Member

Daria's practice ranges from transactional matters to general counsel services. She has extensive experience with the merger and acquisition of hospitals, long-term care facilities, clinics, assisted living facilities, home health and hospice programs, group practices, and other provider entities. She guides clients through the regulatory aspects of capital projects and other strategic initiatives. Active in health care reform matters, Daria is currently working with clients on ACO formation, clinical integration and affiliation, and similar arrangements. In addition, Daria...

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