Charting the Course of Post-Acute and Long-Term Care Medicine Presentation: Navigating the Choppy Waters of Medical Cannabis Presenter: William D. Shaughnessy, Jr., Esq. wshaughnessy@gfrlaw.com

Disclosure of Interest Mr. Shaughnessy provides legal services to medical cannabis growers in Maryland – SunMed Growers, LLC – and to the trade association of Maryland medical cannabis growers - CANMD

Navigating the Choppy Waters of Medical Cannabis Objective: Gain an understanding of the laws regarding medical cannabis

Legal Background Medical Cannabis is Federally illegal Schedule 1 drug under Controlled Substances Act – no prescription Consequences: possible arrest, forfeiture, etc. Few studies on medical efficacy of cannabis Medical Cannabis is legal under laws of some States As of 2018, 31 states plus DC and Puerto Rico have legalized the use of medical cannabis for certain conditions

Legal Background, cont’d Conflict between Federal and State law Risks of federal prosecution of activity that is legal under state law. “Rohrbacher amendment” – no DOJ funding for federal interference of state legal cannabis. January 2018 - Sessions withdrew Obama era guidance known as Cole Memorandum U.S. attorney discretion

General Framework of State Laws State legislation and regulations passed Medical certification/recommendation Registration of qualifying patient Medical cannabis card issued Medical cannabis obtained by registered qualified patient at regulated outlets THUS, AUTHORIZATION IS BY STATE, NOT MEDICAL PROVIDER

State legalization- Maryland – law effective 10/1/2013; regs effective 9/14/ 2015 Md. Code, Health-Gen. § 13-3301 COMAR 10.62.01.01 et seq. Regulatory authority: Maryland Medical Cannabis Commission https://mmcc.maryland.gov/Pages/home.aspx

State legalization- Delaware – law effective 7/1/2011; regs effective 6/11/ 2012 Del. Code Title 16, Chapter 49A 16 Del. Admin. Code Chapter 4470 Regulatory authority Office of Medical Marijuana, Division of Public Health https://dhss.delaware.gov/dph/hsp/medmarhome.html

State legalization- D.C. District of Columbia law effective 7/27/2010; regs effective 12/2/2011 D.C. Code § 7-1671.01 et seq. 22-C DCMR § 100 et seq. Regulatory authority: Division of Medical Marijuana and Integrative Therapy, Department of Health https://dchealth.dc.gov/service/medical-marijuana-and-integrative-therapy

Who “certifies” a patient? Who can “recommend” or “certify” a patient? Terminology – no prescription Maryland**: Physician Nurse Dentist Podiatrist **Must have Maryland controlled dangerous substance registration **Must be registered by the Maryland Medical Cannabis Commission (“MMCC”)

Who “certifies” a patient?, Cont’d Delaware Only “licensed physician” issues certification MD or OD D.C. Only the following licensed and in good standing to practice may “recommend”: Medicine Osteopathy advanced practice registered nursing Dentistry naturopathic medicine physician assistant

Must those who “certify” separately register with regulatory authority? Maryland Yes – must be registered with MMCC Delaware No; but Program may contact physician to verify Certification D.C. No

Conditions for which medical cannabis can be recommended - Maryland A chronic or debilitating disease or medical condition that results in a patient being admitted into hospice or receiving palliative care; or A chronic or debilitating disease or medical condition or the treatment of a chronic or debilitating disease or medical condition that produces: Cachexia, anorexia, or wasting syndrome; Severe or chronic pain; Severe nausea; Seizures; or Severe or persistent muscle spasms. Qualifying medical conditions listed on MMCC website include glaucoma and PTSD

Conditions for which medical cannabis can be recommended – Delaware Terminal illness, cancer, HIV, AIDS, decompensated cirrhosis, amyotrophic lateral sclerosis, agitation of Alzheimer's disease, post-traumatic stress disorder, intractable epilepsy, seizure disorder, or the treatment of these conditions. A chronic or debilitating disease or medical condition or its treatment that produces 1 or more of the following: cachexia or wasting syndrome; severe, debilitating pain that has not responded to previously prescribed medication or surgical measures for more than 3 months or for which other treatment options produced serious side effects; intractable nausea; seizures; severe and persistent muscle spasms, including those characteristic of multiple sclerosis.

Conditions for which medical cannabis can be recommended – D.C. HIV; AIDS; Glaucoma; Severe and persistent muscle spasm, such as multiple sclerosis; Cancer; or Other condition, that is chronic, debilitating for which the use of medical marijuana is beneficial Other condition for which treatment with medical marijuana would be beneficial, as determined by the patient's authorized practitioner [BROAD]

Maryland Requirements for Issuing Patient Certification Maryland Certifying provider must: (1) determine patient has registered with the Commission; (2) have a bona fide physician-patient relationship; (3) determine patient meets the certifying physician's inclusion criteria; (4) determine patient must not meet the certifying physician's exclusion criteria;

MD Requirements for Issuing Patient Certification, Cont’d Maryland Certifying provider must: (5) determine that the potential benefits of the medical use of cannabis likely outweigh the health risks for the patient. (6) Log onto the website of the Commission to transmit the written certification to the Commission; and (7) If requested, provide a copy of the written certification to the qualifying patient.

“Bona Fide Physician- Patient Relationship” - Maryland “Bona fide physician-patient relationship” means a treatment or counseling relationship between a physician and a patient in which the physician has: (a) Reviewed the patient's relevant medical records and completed an in person assessment of the patient's medical history and current medical condition; (b) Created and maintained records of the patient's condition in accord with medically accepted standards; and (c) A reasonable expectation that the physician will monitor the progress of the patient while using medical cannabis and take any medically indicated action: (i) To provide follow-up care to the patient; (ii) Regarding the efficacy of the use of medical cannabis as a treatment of the patient's severe or debilitating medical condition; and (iii) Regarding any adverse event associated with the use of medical cannabis. COMAR 10.62.01.01

“Bona Fide Physician- Patient Relationship” – Delaware & D.C. Requires “bona fide physician-patient relationship” bona fide physician-patient relationship may not be limited to authorization for the patient to use medical marijuana or consultation for that purpose D.C. Requires “bona fide relationship” Cannot be an owner, director, officer, member, incorporator, agent, or employee of a dispensary, cultivation center, or testing laboratory.

Reporting requirements of certifying providers Maryland Certifying provider must be registered with Commission Certifying provider must log onto the website of the Commission to transmit the written certification to the Commission Commission maintains and publishes a list of certifying providers Delaware Certifying providers do not generally centrally report certification, but provide a certification to patient The Program may contact the physician to verify the certification.

Reporting requirements of certifying providers, cont’d D.C. Providers do not generally centrally report recommendations, but sign patient applications and form is prescribed by Department for recommendations. Department maintains a confidential record, not subject to FOIA, of each recommending authorized practitioner for the purpose of monitoring compliance with the Act. Provider must notify the Department in writing within fourteen (14) calendar days after advising a qualifying patient that he or she no longer suffers from a qualifying medical or dental condition or treatment.

Protections to Providers who certify or recommend medical cannabis State law protections: Generally providers who certify/recommend in accordance with state law may not be subject to prosecution, civil penalty, or disciplinary action – state law only, not federal. Maryland: Md. Code, Health-Gen. § 13-3313(a)(3) Delaware: Del. Code tit. 16, § 4903A(g) D.C.: D.C. Code § 7-1671.04(c)

Protections to Providers who certify or recommend medical cannabis Federal Law Medical cannabis is illegal under federal law, thus there is no statutory or regulatory immunity to certifying providers from federal law. Conant v Walters (9th Cir. 2002) – Court recognizes federal government cannot punish or threaten to take away licensure solely because physician recommends medical cannabis to a patient – First Amendment concerns apply to relationship. Issue: is “certification” or “recommendation” as part of a state dispensing program protected? Rohrbacher limit on funding Bottom line: federal risk even if not significant

Maryland statistical snapshot Maryland statistics State population: 6.8 million Number of registered medical cannabis patients: 64,300 Approximately 24,300 licensed physicians in Maryland Number of registered providers: 1,075 Physicians: 684 Nursing: 320 Dental: 60 Podiatry: 11

QUESTIONS?