4/26/2018. Medical Marijuana in Long Term Care

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May 7, 2018 1 Medical Marijuana in Long Term Care Current State regulatory environment Current

1 Medical Marijuana in Long Term Care What Providers Should Do To Prepare for the Rollout Charles M. Johnson, Esq. May 7, Medical Marijuana in Long Term Care Current State regulatory environment Current federal enforcement priorities Update on approaches and general strategies in Long Term Care across the US Policy changes Risk management 2 Proposed Medical Cannabis Regions 3 1

Unless you strictly comply with the WVMCA and new regulations, possessing or selling marijuana remains illegal under WV law Marijuana remains illegal under federal law Legal

condition to qualify for medical marijuana: Cancer HIV/AIDs ALS Parkinson s Disease MS Spinal cord/neurological impairment Epilepsy Neuropathy 5 Patients must have a serious

2 Unless you strictly comply with the WVMCA and new regulations, possessing or selling marijuana remains illegal under WV law Marijuana remains illegal under federal law Legal Forms of Medical Cannabis in WV Pill Topical Tincture Liquid Dermal Patch Smoking marijuana to be studied Target Date: July 1, Patients must have a serious medical condition to qualify for medical marijuana: Cancer HIV/AIDs ALS Parkinson s Disease MS Spinal cord/neurological impairment Epilepsy Neuropathy 5 Patients must have a serious medical condition to qualify for medical marijuana : Huntington s Disease Crohn s Disease PTSD Intractable seizures Sickle cell anemia Severe chronic intractable pain Terminal illness 6 2

3 Regulated Entities: Growers (10) Processors (10) Dispensaries (30) Registered Physicians 7 Physician Registration Register with BPH Demonstrate ability to treat one or more serious medical conditions Successfully complete a 4 hour training course Hold valid, unexpired medical license Physician Certification Patient is under physician's care Patient will receive therapeutic or palliative benefit from medical cannabis Other treatments have proven ineffective Certify that patient has a serious medical condition 8 Patient Authorization Patient registers with BPH Physician registered with BPH certified that patient has a serious medical condition Upon approval, BPH issues a card that qualifies the patient to obtain medical marijuana from an approved dispensary Caregivers can obtain and administer for minors and adults that need assistance Caregivers Authorized to receive and administer medical marijuana for qualified patients Caregivers must be over 21 Criminal background check Designated by patient or parent A caregiver may serve up to five patients. 9 3

4 Physician Should Not Prescribe Medical Marijuana Physicians recommend or certify the need acknowledge serious medical condition acknowledge patient will benefit recommend patient for program documentation Physicians and caregivers have limited protection under the MCA Physicians and caregivers complying with the MCA have protection from ethical challenges in WV 10 West Virginia Medical Cannabis Act Safe Harbors Any of the following persons acting in accordance with the provisions of this article may not be subject to arrest, prosecution, or any civil or administrative penalty, including.disciplinary action by a professional licensing board or be denied any right or privilege for the medical use of cannabis: Qualifying patients: In possession of a 30 day supply In possession of greater then a 30 day supply if physician certified inadequate to meet the patient s needs Growers Certifying Physicians Caregivers Dispensaries Processors Hospital, medical facility or hospice program where a qualifying patient is receiving treatment Strict compliance and current federal restrictions may deter federal prosecutions for these providers that allow MM use by patients WVC 16-8A West Virginia Medical Cannabis Act Restrictions Practitioner restrictions. (a)(1) A practitioner may not accept, solicit or offer any form of remuneration from or to a prospective patient, patient, prospective caregiver, caregiver or medical cannabis organization, including an employee, financial backer or principal, to certify a patient, other than accepting a fee for service with respect to the examination of the prospective patient... (a)(2) A practitioner may not hold a direct or economic interest in a medical cannabis organization. (a)(3) A practitioner may not advertise the practitioner s services as a practitioner who can certify a patient to receive medical cannabis. Is advertising ban workable and constitutional? WVC 6A

The Need for Medical Cannabis in WV Informal surveys to gauge need in Medicaid and PEIA population (2017) 2,120 patient responders reported that they suffered from chronic pain 1,579 reported that

5 The Need for Medical Cannabis in WV Informal surveys to gauge need in Medicaid and PEIA population (2017) 2,120 patient responders reported that they suffered from chronic pain 1,579 reported that they had PTSD 807 reported neuropathies 8,632 claims submitted for neuropathy(peia) 8,378 submitted claims for cancer (PEIA) 6,561 submitted claims for chronic pain (PEIA) 13 The Need for Medical Cannabis in WV 55,666 claims were submitted for patients with cancer(medicaid) 25,101 claims were submitted for patients with chronic pain (Medicaid) 10,692 claims were submitted for patients with PTSD Of the 1,455 physicians participating in an online survey, 82 percent expressed an interest in participating in the medical cannabis program 14 Clinical benefits of medical cannabis Primary psychoactive compound Delta 9-Tetrahydrocannabinol (THC) Primary Non-psychoactive compound-- Cannabidiol(CBD) THC/CBD ratio determines the relative psychoactive/ therapeutic effect FDA approved derivatives Drobinol (Schedule III) Nabilone (Schedule II) Epidolex (under consideration) In 17 States that legalized Medical Cannabis as of 2013, use of opioids fell precipitously and Medicare part D saved $165 million 15 5

Clinical benefits of medical cannabis Sativa High ratio CBD/THC Stimulating effect alertness Sense of well-being and ease Mental and behavioral issues, anorexia Indica High THC/CBD ratio Relieve

6 Clinical benefits of medical cannabis Sativa High ratio CBD/THC Stimulating effect alertness Sense of well-being and ease Mental and behavioral issues, anorexia Indica High THC/CBD ratio Relieve stress Aide in sleep Insomnia, chronic pain, muscle spasms and nausea MS, fibromyalgia 16 Anecdotal Evidence Norma Winkler, 82 takes ¼ teaspoon of cannabis oil in applesauce, helps her sleep and to endure chronic back pain Its been a real lifesaver for me I wouldn t go if they did not allow me to take it (Rhode Island), New York Times (October 27, 2017) Margo Bauer, 75, was desperate in dealing with chronic nausea, vomiting, pain from multiple sclerosis She now grows her own cannabis plant at an ALF Now Margo has organized a collective at the ALF and started an all-female synchronized swimming team The Atlantic (July 22, 2013) 17 Anecdotal Evidence Ruth Brunn, 98, suffers from neuropathy and jabbing pains in her wheelchair Ruth now takes a green pill that has cannabis oil with her vitamin water and sits back and waits for the pain to subside I don t feel high or stoned All I know is that I feel better when I take this Hebrew Home at Riverdale in NY now helps residents with medical marijuana The New York Times (February 19, 2017) Anita Mataraso, 72, uses MM to curb pain arthritis at a retirement community near SF I would be in a lot worse shape if I wasn t using cannabis both physically and mentally AARP (February 21, 2017) 18 6

Clinical Risks Dependence 9% if never used and 16% if started in adolescence Risks of falls Increased heart rate Liver absorption THC content has Increased Dramatically Isolated examples of negative

7 Clinical Risks Dependence 9% if never used and 16% if started in adolescence Risks of falls Increased heart rate Liver absorption THC content has Increased Dramatically Isolated examples of negative consequences Driving impaired has increased Gateway drug 19 Current State Regulatory Environment 29 States and D.C. have adopted medical marijuana laws 7 States and D.C. have adopted recreational marijuana laws 33 States have adopted industrial hemp laws 17 States have laws allowing marijuana extracts Regulated entities must strictly comply with WV Medical Cannabis Act and Regulations 20 Current Federal Enforcement Environment Under the CSA it is illegal to manufacture, import, posses, use, and distribute marijuana (cannabis)(21 U.S.C. 801) Marijuana is a Schedule I drug Under WVC 60A-4-401, it is illegal: a) to manufacture, deliver or possess with intent to manufacture or deliver a controlled substance (felony) c) to unlawfully possess a controlled substance unless obtained from a valid prescription order of a practitioner while acting in the course of his professional practice or as otherwise authorized by this Act (misdemeanor) 21 7

8 Current Federal Enforcement Environment DOJ issued guidance on federal enforcement priorities and guidance regarding marijuana related activities (2013) The Cole Memo established federal enforcement priorities Rohrabacher Blumenauer Amendment USAG Jeff Sessions rescinded the Cole Memo (1/4/18) Prohibition against use of federal funds in specific states that authorized medical marijuana now extended through 9/2018 WV MCA provides some State safeguards US Attorney for Southern District of WV Adopts Aggressive Enforcement Approach 22 Rewgulatory and Legal Risks in Authorizing Medical Cannabis Violations of Medicare Conditions of Participation Loss of Medicaid Enrollment Loss of DEA License Loss of Federal Tax Exemption for Nonprofits Denial of Malpractice Claims Criminal penalties for personnel Ethical violations for professionals Risk management 23 Medical Marijuana in Long Term Care Regulatory Risks- Skilled Nursing/Long Term Care (b) provides services in compliance with all federal, State and local laws Resident rights. (a) Residents rights. The resident has a right to a dignified existence, self-determination, and communication with and access to persons and services inside and outside the facility, including those specified in this section. (b)(1) The facility must ensure that the resident can exercise his or her rights without interference, coercion, discrimination, or reprisal from the facility 24 8

9 Medical Marijuana in Long Term Care Regulatory--Risks Home Health Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. The HHA and its staff must operate and furnish services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients. If state or local law provides licensing of HHAs, the HHA must be licensed Condition of participation: Patient rights. (c) Standard: Rights of the patient. The patient has the right to (1) Have his or her property and person treated with respect; (4) Participate in, be informed about, and consent or refuse care in advance of and during treatment 25 Medical Marijuana in Long Term Care Regulatory Risks Hospice Condition of participation: Patient's rights. The patient has the right to be informed of his or her rights, and the hospice must protect and promote the exercise of these rights.] (b) Standard: Exercise of rights and respect for property and person. (1) The patient has the right: (i) To exercise his or her rights as a patient of the hospice; (ii) To have his or her property and person treated with respect; (iv) To not be subjected to discrimination or reprisal for exercising his or her rights. 26 General Strategies in Long Term Care Strictly Prohibit Use of Medical Cannabis and Discharge Patients that Participate Don t Ask Don t Tell Allow Family or Other Third Party Caregivers to Administer Medical Cannabis Authorize Staff to become Caregivers and Integrate into Services Provided 27 9

10 General Strategies in Other States Use of MM increased 57.8% from 2006/07 to 2012/13 for adults aged 50 to 64 Use of MM increased 250% from 2006/07 to 2012/13 for the 65 and older population California Federal law prohibits SNFs from dispensing MM (10/2015) Colorado a few SNFs are allowing MM in SNFS; ALFs are allowing MM; don t ask don t tell policy pervasive (10/2015) New York MM firm wins nursing home contract; Etain Health will supply Bronx nursing home with Medical Cannabis products-- Marijuana Business Daily (February 14, 2017) 28 Recommendations Consult State Ombudsman Consult OHFLAC Consult BMS Obtain consent from resident, POA and/or guardian Develop policies regarding use by residents, caregivers, storage, where use is permitted, notice when brought, release by resident, MAR, etc. Storage and diversion polices Verify authority of resident to use Verify authority of caregivers to pick up and administer Ethical considerations Verify insurance coverage 29 Disclaimer: This is intended for education purposes and is not intended to serve as legal advice Anyone considering programs that allow the use of medical marijuana in long term care must carefully weigh the risks and the rewards and the changing legal landscape Consult with your own attorney as to specific situations Under federal law, possession or sale of marijuana is illegal so changes in enforcement priority or other scrutiny can result in federal prosecution 30 10

A Any questions? Charles M. Johnson, Member Frost Brown Todd, LLC United Center, Suite 1100 500 Virginia Street East Charleston, WV 25301 (304) 348-2420 (304)345-0115 (Fax) cmjohnson@fbtlaw.

11 A Any questions? Charles M. Johnson, Member Frost Brown Todd, LLC United Center, Suite Virginia Street East Charleston, WV (304) (304) (Fax) 31 Medical Marijuana References Bradford, et. al, Medical Marijuana Laws Reduce Prescription Medication Use in Medicare Part D, Health Affairs, (July 2016). Goselin, et. al. Senior s Use of medical marijuana in Alf s and SNF s (2018) mentation.pdf Medical Marijuana References

12 Medical Marijuana Articles:

Weeding Through the Workplace Impact of Medical Marijuana

Weeding Through the Workplace Impact of Medical Marijuana Steven T. Boell, Shareholder The Landscape in General Medical Marijuana is Big Business In 2015 estimated legal U.S. cannabis sales were $5.7 billion,