Becoming a registered practitioner under the Medical Marijuana Program could provide pain management alternatives to opioids, grow your patient base, expand your practice, and increase revenues. New York State’s Medical Marijuana Program now makes it easier for practices to certify patients by adding more qualifying conditions (such as chronic pain)[1], increasing the number of medicinal manufacturers[2], and allowing nurse practitioners and physician’s assistants to certify patients.[3]
However, only one of three patients will have their consultation covered by insurance, once registered, practitioners typically receive up-front cash and can quickly recoup their costs with just a few booked appointments.[4] Navigating the registration process for the Medical Marijuana Program, qualifying for the program, and meeting ongoing compliance requirements are vitally important – and missteps can result in steep penalties. Legal counsel ensures a smooth and lawful integration of marijuana certification into your practice.
Federal Law
It is important to note that despite medical marijuana laws in 28 states and Washington D.C., marijuana is still illegal under federal law. The federal government regulates drugs through the Controlled Substances Act (CSA) (21 U.S.C. § 811), which does not recognize the difference between medical and recreational use of marijuana. In 2013, the Department of Justice issued a guidance memorandum to prosecutors concerning marijuana enforcement under the CSA, making it clear that prosecuting state legal medical marijuana cases is not a priority. Even still, decisions about prosecution are still left to the discretion of the federal government and this guidance is subject to change, especially in light of a new Presidential Administration.
As of today, the federal government claims that marijuana is not medicine and in Gonzales v. Raich (2005), the U.S. Supreme Court held that the federal government has the constitutional authority to prohibit marijuana for all purposes. However, the Raich decision does not say that the laws of New York (or any other medical marijuana state) are unconstitutional. Doctors may not “prescribe” marijuana for medical use under federal law, but they have protection under the First Amendment to “recommend” its use.[5]
Because of federal nuances, the role of practitioners in New York’s Medical Marijuana Programs is to inform patients that they meet or do not meet the qualifications to become certified to obtain medical marijuana. Practitioners do not prescribe medical marijuana, instead they certify that a patient has a qualifying condition. Once the patient is certified and registered, the patient pays for and obtains their medicine through a distributor.[6] In addition, the laws afford registered patients, care givers, cultivators, and distributors immunity from the consequences of state criminal laws.[7]
Registration and Compliance
Practitioners seeking to issue certifications for medical marijuana must satisfy multiple requirements set forth by the Department of Health (DOH) such as:
- Completing a four-hour marijuana certification course;
- Obtaining a valid Drug Enforcement Administration registration;
- Being qualified to treat patients with one of the ten eligible serious conditions.[8][9]
The four-hour DOH certification course can be accessed online through TheAnswerPage, costs $249 to take, and provides 4.5 hours of CME credits. Following successful completion of the DOH approved course and full compliance with the §1004.1(a) requirements, practitioners may register with the DOH Medical Marijuana Program which is as simple as emailing the completion certificate to the DOH along with the practitioner’s state license number and Health Commerce System (HCS) User ID. Upon validation of the information provided, the DOH sends an e-mail confirmation to the practitioner containing a link to authorize the practitioner to register.
Completing the registration process grants practitioners access to the Medical Marijuana Data Management System, to issue certifications to qualifying patients. Registered practitioners must consult the Prescription Monitoring Program (PMP) registry prior to issuing certifications to patients. The PMP registry contains controlled substance prescription dispensing history and medical marijuana dispensing history.[10]
Ongoing Practitioner Compliance and Prohibitions:
Once registered, practitioners need to take extra care that they are in compliance with the rules and regulations of the Medical Marijuana Program. Sections 1004.2(a)(1)-(15) lists the extensive and detailed requirements for what needs to the included on certifications, while subsection (b)-(d) discuss certificate filing requirements, expiration, and record retention.
Practitioners must also report to the DOH the death of a certified patient or change in status of a serious condition involving a certified patient, if such change may affect the patient’s continued eligibility for certification for use of approved medical marijuana product. Depending on the circumstances, the deadlines to submit these reports to DOH may be very short.[11] Practitioners are also placed under strict prohibitions concerning conflicts of interest, offers from manufacturers, patient discounts, examination procedures, benefits, financing, related parties, and sampling.[12]
Conclusion:
The Medical Marijuana Program provides new opportunities for pain management and health care practices. Like any healthcare regulation, the Medical Marijuana Program is highly regulated and contains very specified rules that carry steep penalties. Practitioners considering adding medical marijuana certification to their practice should first seek legal advice on business development, financial and asset protection, insurance review, and to ensure DOH compliance. The attorneys at Colligan Law have advised practitioners looking to boost their practice by adding medical marijuana certification and are well versed in these aspects healthcare compliance and business protection.
This article is meant to convey general information, and not to provide any legal advice. Legal advice should be provided only by an attorney who is familiar with all the circumstances about which advice is requested.
[1] https://www.health.ny.gov/press/releases/2016/2016-12-01_chronic_pain_condition_added.htm
[2] http://www.timesunion.com/tuplus/article/NY-seeks-updated-medical-marijuana-company-10954792.php
[3] https://www.health.ny.gov/press/releases/2016/2016-11-22_medical_marijuana_program_expansion.htm
[4] https://www.drugpolicy.org/sites/default/files/NY%20MMJ%20Implementation%20Report%20Q1%20June%2013%202016.pdf
[5] See Conant v Walters, 309 F3d 629, 632 (9th Cir 2002).
[6] See N.Y. PUB. HEALTH §§3360 to 3369-E.
[7] See N.Y. PUB. HEALTH §3369.
[8] See 10 NYCRR §1004.1(a).
[9] Serious conditions include: cancer, HIV or AIDS, (ALS), Parkinson’s disease, multiple sclerosis, spinal cord injury with spasticity, epilepsy, inflammatory bowel disease, neuropathy, or Huntington’s disease. For a full definition of the eligible conditions see: NY Pub Health L § 3360(7).
[10] http://www.health.ny.gov/professionals/narcotic/prescription_monitoring/online_notification_program/
[11] See Section 1004.19(a)-(c).
[12] See Section 1004.22(a)-(e).