In Pennsylvania medical marijuana is almost here. Business licenses have been issued, dispensaries are being built, and physicians are getting approved as "Practitioners". Who will be their patients and how will dispensaries attract patients are unanswered questions as of yet.
The new regulations do set forth very specific proscriptions about who can certify a patient, which patients can be certified to receive a medical marijuana card, and the extent to which certifying practitioners are allowed to participate in this new business space. This blog will discuss some of these issues.
Firstly, only physicians registered and approved by the Department of Health ("DOH") as "Practitioners" may certify a patient to receive medical marijuana. To qualify, a Practitioner must have an active, unrestricted medical or osteopathic license in the Commonwealth of Pennsylvania issued pursuant to the Medical Practices Act or the Osteopathic Medical Practice Act. Only the DOH determines if Practitioners are qualified to treat patients with one or more serious medical conditions. These conditioners are not listed in the regulations.
To become a DOH Practitioner pursuant to medical marijuana regulations the physician must take a four hour training course. The training course shall include important responsibilities of Practitioners under the Medical Marijuana Act, general information regarding medical marijuana under federal and state law, the scientific research regarding the risks and benefits of medical marijuana, and recommendations for medical marijuana as it relates to the continuing care of pain management, risk management opiate addiction, palliative care, overdosing on medical marijuana, informed consent, and other areas to be determined by the DOH. 1181.32. All Practitioners must be familiar and compliant with the Prescription Drug Monitoring Program. A physician must possess knowledge of best practices regarding medical marijuana dosage based upon a patient's serious medical condition and the medical professional's medical training and specialty. These provisions, while very vague and ambiguous, are extremely extensive.
Once, a physician is approved as a Practitioner (which has not yet happened), what is the process they must follow to issue patient certifications (the medical marijuana card)? The physician patient initial or follow up consultation must be complete, in person, and documented in the patient's healthcare records contemporaneous to the issuance of a patient certification. Any medical marijuana certification can only be issued consistent with (AFTER REVIEWING) the patient's Prescription Drug Monitoring controlled substance use history. That law is found at 35 P. S. 872.1-872.40. A violation of the monitoring law is a Drug Act violation.
These initial evaluations could become the lynch pin of future disciplinary action against rouge physician Practitioners. Practitioners can not simply meet a patient claiming to suffer from "cancer" or a "serious" medical condition and issue a patient certification. The doctor patient consultation must be complete and extensive. These patients must already have a "serious" medical condition. Practitioners must secure documentation of such prior to or contemporaneous with the patient certification. Up to date X-rays, MRI's, biopsy results, specialist's reports, prescription drug histories, and/or copies of a complete medical history file should be secured before issuing the patient certification. The Practitioner who does not initiate a best practices for these initial patient consultations will expose themselves to unhappy patients (who expect their certification at the first consultation) and disciplinary action for practicing below the standard of care and in violation of DOH medical marijuana regulations.
Patient certifications require complete patient identifiers, along with the diagnosis, assumption of continuing care for the patient, and the length of time (not exceeding one year) that the marijuana treatment would be palliative or therapeutic. 1181.27. The Practitioner must also recommend either a specific dosage or consultation with the dispensary employee to recommend dosage. Importantly, Practitioners may not receive or provide medical marijuana product samples -- suggesting their patients "try this" to "see how it works".
Patient certifications are easily revoked. Practitioners SHALL notify the DOH in writing if they know or have reason to know that one of their certified patient has recovered from their "serious" medical condition, the patient has died, or the medical marijuana use would no longer be therapeutic or palliative. 1181.28-29. The regulations allow a Practitioner to withdraw the issuance of a patient certification at any time, without any reason, upon written to notification to both the patient and DOH. 1181.29. This will be interesting in practice how these provisions play out. Cancelling a certification could generate patient complaints to DOH and subsequent DOH disciplinary action. Hence, full compliance with all patient contact and documentation requirements to properly answer a DOH - and possible Medical Board - investigation is paramount and prophylactic. DOH will be vigilant against any medical Practitioner violating these regulations.
Once a patient receives DOH revocation notification, the same is entered in the electronic tracking system. Any subsequent distribution of medical marijuana to an uncertified patient shall be a violation of the Prescription Drug Monitoring program protocols and, potentially, the criminal laws of the Commonwealth of Pennsylvania. Here is where the trouble for Practitioners lie. Any improper certification will become a violation of the Drug Act, possibly a felony, thereby creating automatic license suspension issues.
Department of Health regulations allow for a Practitioner to be removed from the medical marijuana practitioner registry if a Practitioner's medical license is inactive, expired, suspended, revoked, limited or otherwise restricted by the Pennsylvania appropriate medical board. 1181.26. Any physician subject to professional disciplinary action is subject to immediate or temporary suspension of their medical marijuana participation. A physician subject to any professional disciplinary action (Pennsylvania of other state) may be removed for the Practitioner list. Importantly, these provisions only require the initiation of disciplinary action, not any formal conclusion to a disciplinary action. This is a huge provision allowing for emergent and possible automatic suspension from the program and medical license problems. Stay ahead of the investigatory curve; document everything, practice with extreme ethical limitations, assume any patient in your medical practice is not really sick or is an undercover DOH officer recording your every word.
There is an anti-kickback provision in the medical marijuana regulations. 1181.31(a). The only fee for service a practitioner can receive is from an actual or prospective patient consultation. Practitioners cannot accept, solicit or offer any form of remuneration from anybody associated with the dispensary in any manner. (No baseball tickets, diners, college tuition, cars, lunch, Christmas baskets.) All fee for services must be properly schedule and posted. As there is no insurance coverage for these medical services, receipt for payment in cash must provided and properly documented. Accepting credit card payments for these services could expose the Practitioner to federal banking violations. Revenues must be reported to avoid any state or federal tax evasion investigations. Depositing this cash in the bank is a separate issue for a separate blog.
Practitioners are extremely limited to whom they can issue certifications. Practitioners can not be a designated caregiver for a their own patient to whom the Practitioner issues a certification, may not issue a patient certification for themselves or a family or non family household member. Practitioners may not advertise their services as a Practitioner who can certify a patient to receive medical marijuana. 1181.31(b)-(f). Practitioners will require continuing, aggressive management of their qualifications to ensure continued compliance with DOH medical marijuana regulations. A Practitioner under the Act cannot hold a direct or economic interest in a medical marijuana organization.
Any physician removed from the practitioner registry may not have asked electronic access to patient certifications, issue or modify a patient certification, or provide a copy of existing patient certifications to any person parentheses including a patient caregiver, or other medical professional, except in accordance with applicable law.
Call me to discuss setting up your practice or any potential disciplinary issues associated with your practice as a practitioner certifying patients to receive medical marijuana.