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DOH Issues Medical Marijuana Practitioner Rules

April 19, 2017

By: Elizabeth M. Hein, Robin Locke Nagele, and Barbara Rowland

Nearly a year after the Pennsylvania legislature passed the Medical Marijuana Act, 35 P.S. § 10231.101 et seq. (“the Act”), the Department of Health (“DOH”) took a critical step in its regulatory implementation of the Act, issuing proposed temporary regulations for physicians who will be issuing certifications to patients for use of medical marijuana.  See 28 Pa. Code 1181.21 et seq. The comment period for these temporary regulations runs through April 20, 2017. Following close of the comment period, DOH will finalize and release its final temporary regulations. This article discusses the key proposed temporary regulations, which implement the core statutory requirements for physicians seeking to issue patient certifications and highlight steps physicians can take to reduce potential liability when recommending medical marijuana use for patients.  

Registration

In order to issue patient certifications, a physician must register with DOH.  To receive approval for inclusion on the registry, a qualified physician must submit an application, and complete a 4-hour training course.1 The regulations do not specify an application fee for physicians seeking to register with DOH. 

DOH will maintain a registry of approved practitioners, which will be publicly accessible, and will use the registry as a tool for exercising oversight over physicians.2  The inclusion of a physician in the registry shall be subject to annual review to determine if the physician’s license is inactive, expired, suspended, limited, or otherwise restricted, or if the physician has been subject to professional disciplinary action. A practitioner may be removed if his or her license is inactive, expired, suspended, limited, or otherwise restricted, or if the physician has been subject to professional disciplinary action.3

Certifications

The key temporary regulations recently issued by DOH are those addressing physician certifications for medical marijuana use.  As will be discussed further below, the regulations are notable, and raise a number of questions, in that they: (1) permit a practitioner to issue a certification for medical marijuana without specifying the form of medical marijuana to be used, and (2) require that a practitioner obtain informed consent in connection with a medical marijuana certification. 

Certifications Generally

In order to issue a certification to a specific patient, a practitioner must:

  • Determine that the patient has a serious medical condition4 and document the serious medical condition in the patient’s health care record;
  • Confirm that the patient is under the practitioner’s continuing care for the serious medical condition;
  • Determine, in the practitioner’s professional opinion and review of past treatments, that the patient is likely to receive therapeutic or palliative benefit from the use of medical marijuana.5

The certification must include, among other things, any requirement or limitation concerning the appropriate “form of medical marijuana,” and limitation on the duration of use, if applicable.6  The “form of medical marijuana” is a defined term under the Act, and refers to the “characteristics of medical marijuana recommended or limited for a particular patient, including the method of consumption, and any particular dosage, strain, variety, and quantity or percentage of medical marijuana or a particular active ingredient.” 7

A patient or caregiver may not obtain more than a 30-day supply of individual doses from a dispensary.8  The Act charged DOH with developing a standard certification form, although it does not appear that the form has been published to date.9

Form of Medical Marijuana

The new temporary regulations permit a practitioner, upon issuing a certification to a patient for medical marijuana, to either (i) identify the form of medical marijuana to be used, or (ii) to recommend that the patient discuss the form of medical marijuana with the physician or pharmacist at a dispensary.10 

The fact that a physician may issue a recommendation for medical marijuana use without specifying the form of marijuana to be used is controversial. While the physician is ultimately responsible for identifying any applicable requirement or limitation on the duration of use or appropriate form of medical marijuana on the certification form,11 this regulation appears to allow the physician to leave the form of medical marijuana up to the dispensary, provided the form dispensed does not exceed any limitations contained within the certification. 

The reason for this sharing of responsibility for determining the form of medical marijuana for a particular patient is unclear. Until recently, for instance, the American Society of Addiction Medicine recommended against issuing a certification for use of medical marijuana unless the physician had adequate information regarding the composition and dose of the cannabis product.12  Providing an evidence-based recommendation about the risks and benefits of marijuana, and obtaining comprehensive patient consent, is difficult when the type and dose of the product are determined by another professional. Moreover, allowing a physician or pharmacist at another entity to identify the dose and type of marijuana to be used by the question raises thorny issues about the division of legal responsibility between certifying physicians and dispensaries.  

Informed Consent Requirement

In connection with issuing a certification for medical marijuana use, practitioners are also required to affirm that the practitioner has “explained the potential risks and benefits of the use of medical marijuana to the patient, and has documented in the patient’s health care record that such explanation has been provided to the patient, and informed consent has been obtained.”13  This requirement reflects an acknowledgment that certain legal duties likely still apply to physicians issuing medical marijuana certifications, even though such recommendations are not formal prescriptions. Historically, the certification process has been seen as a way to escape the legal responsibility that attaches to a prescription. A “prescription” for the medical use of medical marijuana is illegal under federal law because marijuana is a Schedule I drug, and puts physicians at risk of liability for “aiding and abetting” the possession or distribution of marijuana. By contrast, a “recommendation” or “certification” for medical marijuana has been defended as an exercise of physician free speech.  See Conant v. Walters, 309 F.3d 629 (9th Cir. 2002), cert. denied Oct. 14, 2003.14  A regulatory requirement that a physician obtain informed consent from a patient prior to issuing a certification for medical marijuana use suggests that the distinction is unlikely to relieve physicians of the duty to provide competent professional care to patients in this context.

While no court to date has addressed a professional liability claim against a physician for issuing a medical marijuana certification, it is likely only a matter of time before such an action is brought. To comply with the regulatory requirement, and as a matter of risk management, physicians should be prepared to show that they have adequately obtained the patient’s informed consent for the treatment plan, which means they must provide the patient with any material information that is likely to bear on the decision to take medical marijuana.15  Pennsylvania has a “patient-centered” approach to informed consent, meaning a physician must provide information, including discussion of risks, benefits, and treatment alternatives that a reasonably prudent patient would want to know. Physicians obtaining informed consent from candidates for medical marijuana certification should have a discussion with the patients about the benefits and risks of use of medical marijuana for the particular serious medical condition, including discussion of the possibility of unknown risks, the availability of alternative treatments, such as FDA-approved medications, the possibility of interactions with other medications, and discussion of risks associated with lack of control over the manufacturing of medical marijuana products (such as contamination).16  The consent process should also inform patients about the risk of impairment in connection with driving or operating heavy machinery.17 

Though not specifically required by regulation, physicians should be prepared to demonstrate how their certifications are consistent with a standard of care, which will likely be evaluated based on compliance with applicable regulations, and the available scientific evidence at the time of certification. Physicians should also consult with guidance from professional organizations and medical experts regarding standard of practice for recommending medical marijuana, including scheduling routine follow-up visits, ruling out the presence of contraindications for use of medical marijuana, and ensuring that the physician receives information and training about the appropriate dosage and composition of marijuana products.18

Unfortunately, the ability of physicians to discuss the benefits and risks of use of medical marijuana for particular serious medical conditions is hampered by the limited available medical research in this area. Marijuana continues to be listed as a Schedule I controlled substance under Federal law, making it difficult for researchers to conduct research on marijuana.  Researchers must obtain a license from the DEA and have the study approved by FDA. They also must obtain research-grade marijuana through the National Institute on Drug Abuse.19

Other Requirements and Prohibitions

Prior to issuing a certification or recommending a change of amount or form of medical marijuana, it is mandatory for a practitioner to access the prescription drug monitoring program (PDMP) to review the patient’s controlled substances history and consider the effect of medical marijuana use in connection with the patient’s controlled substances history.20  Practitioners may also review the PDMP for purposes of determining whether the patient has received controlled substances prescriptions from other physicians. 

A practitioner included in the registry has an ongoing responsibility to immediately notify DOH in writing if the practitioner knows or has reason to know that a patient for whom the practitioner has issued a certification: (i) no longer has the serious medical condition for which the certification was issued; (ii) medical marijuana would no longer be therapeutic or palliative; or (iii) the patient has died.21  A practitioner must also notify a dispensary of any known adverse reaction to medical marijuana dispensed by that dispensary immediately upon becoming aware of such reaction.22

A practitioner may not issue a certification for medical marijuana for the practitioner’s own use, or for use of a family or household member.23

Finally, the Act restricts the financial relationships between practitioners and patients seeking certification, or dispensaries and grower/processors. A practitioner may not accept, solicit, or offer any form of remuneration to or from a prospective patient, caregiver, or medical marijuana organization, including an employee, financial backer, or principal, to certify a patient, other than accepting a fee for service for examining a patient to determine whether to issue that patient a certification for medical marijuana use. Most importantly, the Act prohibits a practitioner from advertising that the practitioner can certify a patient to receive medical marijuana.24  

Record-Keeping

Physicians who issue patient certifications must be sure to:

  • Document in the medical record that the patient has a serious medical condition;
  • Ensure that the medical record contains a patient medical history;
  • Document the physician’s review of the patient’s prescription history in the PDMP;
  • Document the informed consent discussion, including risk, benefits, and alternative treatment options discussed;
  • Maintain a copy of any certification issued in the patient’s health care record, and ensure that the patient’s medical record supports the clinical decision to recommend use of medical marijuana;
  • Document periodic review of the treatment’s efficacy;
  • Maintain copies of any modifications of patient certifications in the health care record, and communication regarding any revocation of a patient certification;
  • Document communication with DOH upon learning or having reason to know that (i) the patient for whom the practitioner has issued a certification no longer has the serious medical condition for which the certification was issued; (ii) medical marijuana would no longer be therapeutic or palliative for the patient; or (iii) the patient has died.25

Conclusion

Although the implementation of a medical marijuana program in Pennsylvania represents an exciting opportunity for patients to benefit from a potentially therapeutic substance, the opportunity is not without risk for practitioners. Physicians who regularly treat patients with “serious medical conditions” should seek further education and training regarding the risks and benefits of medical marijuana, as well as legal guidance to minimize exposure to malpractice liability and other violations of law.


Disclaimer: This post does not offer specific legal advice, nor does it create an attorney-client relationship. You should not reach any legal conclusions based on the information contained in this post without first seeking the advice of counsel.

About the Authors:

 

Elizabeth M. Hein is an Associate in the Firm’s Health Care Practice Group and Regulated Cannabis Practice Group, providing legal services to the Firm’s health care clients in litigation, regulatory and compliance matters. Ms. Hein’s litigation practice includes assisting in the defense of complex commercial, regulatory and antitrust matters, medical staff litigation, and injunctive proceedings. Her health care consulting services include federal and state regulatory compliance, Fraud-and-Abuse and False Claims Act analysis and consultation, not-for-profit governance, licensing and accreditation, federal and state payment regulation, EMTALA, HIPAA, HITECH, HCQIA, and ACA statutory and regulatory compliance. Learn More

Robin Nagele

Robin Locke Nagele is a Principal in the Firm's Regulated Cannabis Practice Group and Co-Chair of the Firm's Health Care Practice Group. She has a national health care litigation and consulting practice, in which she represents, in complex commercial, regulatory and antitrust matters, proprietary and not-for-profit health care providers, multi-hospital systems, integrated delivery systems, academic/teaching medical centers, and ancillary service providers, along with their medical, executive and corporate leadership. Learn More

Barbara Rowland is a Principal in the Firm's Regulated Cannabis Practice Group and Washington, D.C. Office Chair of the Firm's Internal Investigations & White Collar Defense Practice Group. Her practice focuses on representing corporations and individuals from a variety of industries, including pharmaceutical and medical device manufacturers and distributors, retail pharmacies, pharmacy benefit managers, health care providers, and other government contractors. She conducts internal investigations, counsels clients subject to government investigation, represents executives, managers, and employees in such investigations, and defends clients in related litigation and at trial. Learn More

 

 

Footnotes:


[1] 35 P.S. § 10231.401(a), (b). Further details about the application process, oversight of the registry, and required training are available in the temporary regulations, at 28 Pa. Code §§ 1181.24-26 and 1181.32.

[2] 35 P.S. § 10231.401. 

[3] 28 Pa. Code § 1181.25-26.

[4] A “serious medical condition” includes: (1) cancer, (2) positive HIV or AIDS status, (3) amyotrophic lateral sclerosis, (4) Parkinson’s disease, (5) multiple sclerosis, (6) damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, (7) epilepsy, (8) inflammatory bowel disease, (9) neuropathies, (10) Huntington’s disease, (11) Crohn’s disease, (12) PTSD, (13) intractable seizures, (14) glaucoma, (15) sickle cell anemia, (16) severe chronic or intractable pain of neuropathic origin or severe chronic or intractable pain in which conventional therapeutic intervention and opiate therapy is contraindicated or ineffective, or (16) autism.  35 P.S. § 10231.103. 

[5] 35 P.S. § 10231.403(a)(1)-(4); 28 Pa. Code § 1181.27.

[6] 35 P.S. § 10231.403(b)(6).

[7] 35 P.S. § 10231.103 (definitions).

[8] 35 P.S. § 10231.405. 

[9] 35 P.S. § 10231. 404.  In addition, prior to issuing a certification or recommending a change of amount or form of medical marijuana, a practitioner must review the prescription drug monitoring program.

[10] 28 Pa. Code § 1181.27(b)(7).  A dispensary is required to have a physician or pharmacist onsite at all times during the hours the dispensary is open.  If the dispensary has more than one separate location, a physician assistant or certified registered nurse practitioner may be onsite in lieu of a physician or pharmacist.  A physician, pharmacist, physician assistant, or certified registered nurse practitioner may not issue a certification to authorize patients to receive medical marijuana, or otherwise treat patients.  35 P.S. § 10231.801(b). 

[11] 35 P.S. §10231.403(b)(6). 

[12] See Public Policy Statement on Medical Marijuana (2010), available at http://www.asam.org/advocacy/find-a-policy-statement/view-policy-statement/public-policy-statements/2011/12/15/medical-marijuana.  The more recent Public Policy Statement of ASAM does not include a specific recommendation that physicians refrain from recommending medical marijuana unless they have discussed the form of medical marijuana, but still advises that predictability in dosing in some forms of medical marijuana is difficult to ensure.  See ASAM, “Public Policy Statement on Marijuana, Cannabinoids, and Legalization” (2015), available at http://www.asam.org/docs/default-source/public-policy-statements/marijuana-cannabinoids-and-legalization-9-21-2015.pdf?sfvrsn=0.

[13] 28 Pa. Code § 1181.27(b) (11). 

[14] See Marijuana Policy Project, “‘Prescribing’ Versus ‘Recommending’ Medical Cannabis,” available at https://www.mpp.org/wp-content/uploads/2016/09/Prescribing-vs.-Recommending.pdf (last visited April 14, 2017).

[15] For a more detailed discussion of the elements of informed consent for medical marijuana certification, see Douglas B. Marlowe, “Malpractice Liability and Medical Marijuana,” The Health Lawyer, ABA (December 2016), available at http://bit.ly/2onPYd5

[16] Id. at 9.

[17] Id. at 6 (noting that in Colorado, traffic fatalities involving marijuana roughly doubled in the first two years after legalization). 

[18] Id. at 7-8.

[19] Id.; See Federal DEA Guidance Impacts Pennsylvania Medical Cannabis Research for a more comprehensive discussion of DEA’s regulatory framework for medical marijuana researchers.

[20] 35 P.S. § 10231. 403(c)(1), (2).

[21]35 P.S. § 10231.401(c)(1)-(3). 

[22] 28 Pa. Code § 1181.22(c). 

[23] 35 P.S. § 10231.403(e).

[24] 35 P.S. § 10231.402(a). 

[25] 35 P.S. § 10231.401(c)(1)-(3).