Sherri DeVito, JD Illinois State Medical Society ASMAC Fall Meeting, October 26, 2014

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1 Sherri DeVito, JD Illinois State Medical Society ASMAC Fall Meeting, October 26, 2014

2 Controlled Substances Act (CSA): Schedule I drug No currently accepted medical use Lack of accepted safety for use under medical supervision High potential for abuse Other Schedule I drugs Heroin, LSD, peyote, Ecstasy Cannot conspire, aid, or abet violation of CSA 21 USC 841(a)(1) and 846; 18 USC 2 2

3 The new law Background, patient & physician qualifications, conditions, written certification, patient impact, immunity, restrictions on physicians The new rules Illinois Department of Public Health (IDPH), Illinois Department of Financial and Professional Regulation (IDFPR), Agriculture, Revenue Other impacts Use in public and private places Employment DUI Practice considerations 3

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5 Cannabis Control Act (720 ILCS 550) (1977) Focused on commercial traffickers and large-scale purveyors Act provides wide sentencing discretion Dept. of Human Services can, with written approval of the Dept. of State Police, authorize physicians to possess, produce, manufacture, or deliver cannabis for the necessary treatment of glaucoma, side effects of chemo or radiation treatment in cancer patients, or other procedures certified to be medically necessary (1985 amendment) HB2514 Attempted during 96 th General Assembly (2009): Session Sine Die 5

6 Four year pilot program beginning January 1, 2014 entitled the Illinois Medical Cannabis Pilot Program (MCPP). Implemented through agency rules : IDPH, IDFPR, Agriculture, Revenue Although effective Jan. 1, not implemented until late July Why? No rules. 6

7 Patients can receive up to 2.5 ounces per 14 days of: Usable cannabis: seeds, leaves, buds, flowers *Synthetics prohibited in Chicago, and many forms classified as Schedule I under CSA pursuant to Synthetic Drug Abuse Prevention Act (SDAPA) passed in 2012 Edibles: brownies, bars, cookies, cakes, breads, pastries Other non-refrigerated, non hot-holding items (such as tinctures) 7

8 To become a qualified patient, a person must have a written certificate from a physician that he or she has one or more specific debilitating medical conditions. A physician issuing the written certificate must be: licensed to practice medicine in Illinois, and must maintain a controlled substance license. Not a new concept Example: disabled placards 8

9 Written certification means a document dated and signed by a physician, stating the patient: Is likely to receive therapeutic or palliative benefit; Has a debilitating medical condition; and Is under the physician's care 410 ILCS 130/10(y) 9

10 Requirements for a physician written certification: bona fide physician-patient relationship How many visits? assessment of the qualifying patient's medical history reviewed relevant records conducted an in-person physical examination. **for non-va hospital qualifying patients 10

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12 No written certification per VHA Directive VA providers cannot recommend cannabis, and VHA will not provide or pay for it Still have to register with DPH VA-specific requirements: Veteran receiving care at a VA hospital Illinois resident Qualifying condition VA hospital records DD214 or other document indicating character and dates of service Fingerprint background check Not convicted of excluded offense violent crime defined in Rights of Crime Victims and Witnesses Act or felony conviction for violating state or federal controlled substance law 18 or older 77 Ill. Admin. Code

13 Cancer Glaucoma Positive status for HIV AIDS Hepatitis C ALS Crohn s disease Agitation of Alzheimer s disease Cachexia/wasting syndrome Muscular dystrophy Severe fibromyalgia Spinal Cord Disease (including but not limited to arachnoiditis) Tarlov cysts Hydromyelia Syringomyelia Rheumatoid arthritis Fibrous dysplasia Lupus Intersitial cystitis Hydrocephalus Spinal cord injury Traumatic brain injury and post-concussion syndrome Multiple sclerosis Arnold-Chiari malformation and syringomelia Spinocerebellar ataxia (SCA) Parkinson s disease Tourette s syndrome Myoclonus Dystonia Reflex Sympathetic Dystrophy, RSD (Complex Regional Pain Syndromes Type I) Causalgia CRPS (Complex Regional Pain Syndromes Type II) Neurofibromatosis Chronic Inflammatory Demyelinating Polyneuropathy Sjogren s syndrome Myasthenia Gravis Nail-patella syndrome Residual limb pain (410 ILCS 130/10(h)(1); 77 Ill. Adm. Code ) 13

14 Application includes: Age requirement 18+ Background checks Fees: Basic fee is $100, reduced is $50, caregiver is $25 Photograph Fingerprinting: no more than 30 days prior by Illinois State Police Medical records Written certification: no more than 90 days prior Physician must mail it in! **mail fraud? Application periods 2014: A-L September 1 through October 31; M-Z November 1 through December : Applications accepted year round 14

15 Answer: possibly a lot Without waiver: 2.5 ounces every 2 weeks from designated home dispensary *from intrastate source With waiver: More than 2.5 ounces no maximum specified 410 ILCS 130/10 15

16 Statement why 2.5 ounces every 14 days is not enough Describe how patient will benefit from more How much cannabis is sufficient and for how long waiver in effect On Physician Waiver Recommendation form provided by DPH **current form does not comply with the rules 77 Ill. Adm. Code (b) 16

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18 Inadequate information and materials Previous registry card revoked Did not meet requirements of Act Provided false information Convicted of a felony under Illinois Controlled Substances Act, Cannabis Control Act, or Methamphetamine Control and Community Protection Act or similar or excluded offense 18

19 Fines Up to $1000 for misrepresenting a medical condition or material misinformation to a physician to obtain a written certification $150 for patient failure to notify DPH of change of information (address, condition, caregiver, etc.) 19

20 Physicians will not be subject to arrest, prosecution, or penalty, or denied any right or privilege solely for providing written certifications (410 ILCS 130/25(e)). BUT a physician may be sanctioned for issuing a written certification for a patient not under his/her care or for failing to properly evaluate a patient s medical condition. 20

21 A physician may not: Seek or accept any payment other than a fee for the examination required prior to certifying a patient. Offer a discount for use of a primary caregiver or dispensing organization. Conduct a personal physical examination at a dispensary or at the address of the owner, agent or employee of the sales location or a medical cannabis organization. Refer patients to a cultivation center, dispensing organization, or registered designated caregiver. Advertise in a cultivation center or dispensing organization. 8 Ill. Admin. Code (b)(11); 68 Ill. Admin. Code (l) 21

22 A physician may not (continued): Hold any financial interest in a cultivation center or dispensing organization if the physician certifies patients or is financially connected to a physician who certifies patients. Hold any leadership or ownership or be an employee of a cultivation center or dispensing organization. *However, a cultivation center or dispensing organization may hire a physician as an independent contractor provided the physician s involvement in the cultivation center is limited exclusively to designing or conducting non-proprietary medical research or studies. 22

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24 77 Ill. Admin. Code Part 946 Have largest effect on physicians, most significantly the physician certification requirements 24

25 Physician qualifications: Current, valid medical and controlled substance licenses Bona-fide relationship with patient Complies with generally accepted standards of medicine under MPA of 1987 and state/federal rules Responsible for ongoing care/treatment of patient In-person full assessment of patient s medical history Patient is under physician s care (primary or for debilitating condition or symptoms thereof) Confirms assessed medical history & reviewed other records for previous 12 months (incl other physicians ) Explains risks/benefits 25

26 Patient name, DOB, address, phone number Physician name, address, telephone number, , medical license number, specialty, DEA registration number Time under care of physician Debilitating condition Additional comments, if necessary Statement confirming diagnosis; bona fide relationship; in-person examination; review of medical history; explanation of risks and benefits Physician signature and date 26

27 Record-keeping system to be maintained by physician For all patients for whom the physician has recommended use of medical cannabis Records must be accessible to and subject to review by IDPH and IDFPR *Do not need to maintain separate records Same as normal medical records, plus required elements Keep for minimum of three years from last patient visit IDPH will keep a confidential record of each certifying physician for purpose of monitoring compliance, not subject to Freedom of Information Act 27

28 Over 400 submitted Broad ranging subject matter add disease, technical comments Received more comments than other agencies Access-focused 28

29 Illinois Department of Financial and Professional Regulation Rules 68 Ill. Adm. Code Part 1290 Focus on development and regulation of dispensaries Organization of dispensing districts Application requirements Dispensary registration Registration of dispensary agents Security and recordkeeping requirements Disciplinary provisions Requirements for dispensaries: 1000 feet or more from a school or day care; cannot be owned by a registered patient or caregiver, or someone convicted of certain offenses Up to 60 dispensaries allowed Yearly renewal 29

30 Impact on physicians Focus on no financial interest, whether direct or indirect, in a dispensary if the physician recommends the use of medical cannabis or is in partnership or other fee or profit-sharing relationship with a physician who recommends its use Cannot conduct physical examination of a patient at dispensary Cannot refer patients to dispensary Cannot advertise at dispensary Can work as an independent contractor with a dispensing organization if the physician s involvement is limited to designing, implementing, or conducting non-proprietary medical research or studies 68 Ill. Admin. Code

31 Illinois Department of Agriculture Rules 8 Ill. Adm. Code Part 1000 Requirements for cultivation centers 2,500 feet or more from school or day care; zoning issues Up to 22 allowed, but not more than one registration per ISP boundary Impact on physicians: Direct advertising allowed by cultivation centers to physicians Laboratory testing Physician can request lab results from dispensaries 31

32 Illinois Department of Revenue Rules Medical Cannabis Cultivation Privilege Tax 7% of sales price per ounce (86 Ill. Adm. Code ) Paid only by cultivation center Retailers Occupation Tax (86 Ill. Adm. Code ) Cannabis: 1% plus local taxes Paraphernalia: 6.25% Plus Metro East Mass Transit District Retailers Occupation Tax (.25%) Plus Regional Transportation Authority Retailers Occupation Tax (range from.75% to 1.25% depending on county) 32

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34 Hospital Cannot use in health care facility includes nursing homes, hospice care centers, long-term care facilities Home OK but cannot knowingly use in close proximity to anyone under 18 Car OK but must be in sealed, tamper-evident medical cannabis container Smoke Free Illinois still applies: prohibited places School bus, school grounds, correctional facility, motor vehicle, private residence used at any time to provide licensed child care or similar, any public place 34

35 Employers cannot discriminate Employees who have valid card or are designated caregivers are not subject to arrest, prosecution, denial of right/privilege including disciplinary board action because of using medical cannabis in compliance with Act Zero tolerance policies OK Case by case basis Negligence not OK Such as when operating motor vehicle under influence or engaging in task while under influence that would constitute negligence or professional malpractice or misconduct 35

36 Title II prohibits public entities from denying public services to any qualified individual with a disability In James v. City of Costa Mesa, 700 F.3d 394 (9th Cir. 2012), defendant cities took action to close dispensaries Although medical cannabis allowed in CA, ADA does not apply cannabis is a Schedule I substance 36

37 Illinois Vehicle Code Before: illegal to be under influence of any amount of cannabis (trace law) Now: trace law does not apply to registered user with valid registry card unless impaired Can use standardized field sobriety tests now statutorily recognized to determine cannabis impairment Officer does not have to be a drug recognition expert 37

38 Registered user gives implied consent to field sobriety testing if arrested for DUI or leaving scene of death or personal injury Officer must have factual basis of suspicion Possible suspension/revocation if refuses to submit* Possible suspension/revocation if submits and fails* *Departure from existing IL law! 38

39 Registered user who fails/refuses to submit: No monitoring device driving permit (MDDP) Fail: six-month suspension (1 year for repeat w/in 5 years) Refuse: twelve-month suspension (3 years for repeat) CDL refuse/fail: twelve-month suspension (lifetime ban for repeat) Non-registered user who fails/refuses to submit: Eligible for MDDP can use breath alcohol ignition interlock device 39

40 Where to get information on benefits/problems: Medical specialty societies Journals and academic research Medical cannabis patient groups 40

41 NO PRESCRIBING OF MEDICAL CANNABIS! There is potential liability as with any treatment or prescribed medication Physicians can say no to certification If willing to certify, must comply absolutely with law and rules As employers, must have clear policy on medical cannabis (and other drug) usage 41

42 ISMS Medical Legal Guideline on Medical Marijuana Log in! Patient & Member Resources Medical Legal Resources Illinois Medical Cannabis Pilot Program 42

43 Questions? 43

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