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DEPARTMENT OF HEALTH

Medical Marijuana Program; Medical Marijuana Advisory Board's Report and the Secretary of Health's Decision to Effectuate the Recommendations

[48 Pa.B. 2898]
[Saturday, May 12, 2018]

 Notice is hereby given, under section 1202 of the Medical Marijuana Act (act) (35 P.S. § 10231.1202) of the decision by the Secretary of Health (Secretary) to effectuate the recommendations of the Medical Marijuana Advisory Board (Board) as set forth in the Board's Report, adopted at a public meeting on April 9, 2018, under section 1201(j)(6) of the act (35 P.S. § 10231.1201(j)(6)).

 The following is a list of the recommendations of the Board along with the Secretary's rationale as to whether or not to effectuate each recommendation.

Recommendation # 1: The Medical Subcommittee and the Regulatory Subcommittee recommended that the Medical Marijuana Program (Program) not expand the types of medical professionals who can issue certifications to patients. The Medical Subcommittee and the Regulatory Subcommittee further recommended that the Program continue to accept input from the patient and provider communities and consider adding additional medical professionals in the future. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees with the Board's recommendation to add no additional medical professionals at this time. Because the Program is in its infancy, more time is required to assess the need to expand the types of medical professionals who may issue patient certifications.

Recommendation # 2: The Medical Subcommittee recommended that no medical conditions be removed from the list of serious medical conditions. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees with the Board's recommendation to remove no serious medical conditions from the act. Because the Program is in its infancy, more time is required to assess the need to remove medical conditions from the list of serious medical conditions as defined in the act.

Recommendation # 3: The Medical Subcommittee and the Patient/Caregiver Subcommittee recommended that ''Severe chronic or intractable pain in which conventional therapeutic intervention and opiate therapy is contraindicated or ineffective'' be changed to ''Severe chronic or intractable pain.'' The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. The Secretary agrees that broadening this condition will provide an opportunity of relief for more persons who would benefit from the use of medical marijuana to treat their severe chronic or intractable pain.

Recommendation # 4: The Medical Subcommittee recommended that a process be established for a subcommittee of the Board to review and approve additional serious medical conditions on a continuous basis. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. The Secretary agrees that as more information is obtained through research under Chapter 20 of the act (35 P.S. §§ 2001—2003) concerning the efficacy and utility of medical marijuana as medication for the serious medical conditions as defined by the act, it may be appropriate to add to the list of serious medical conditions to provide relief to patients and access to a drug that may be the only course of treatment or palliative care available.

Recommendation # 5: The Medical Subcommittee recommended that patients under 18 years of age be certified by a practitioner who is board eligible/certified in pediatrics or pediatric specialties, neurology with special qualifications in child neurology, child and adolescent psychiatry or adolescent medicine (whether through pediatrics, internal medicine or family practice). The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations, but on a delayed basis. Because of the potential effects of medical marijuana use on a developing brain, a practitioner with specialized knowledge relating to minor patients is preferred; however, the number of registered practitioners meeting these qualifications and accepting new patients is, at present, too limited to effectuate this requirement without delaying much needed medicine to a vulnerable population of patients. Therefore, the provision will not become effective until there are a sufficient number of practitioners who meet these qualifications and who are registered with the Department of Health (Department) to provide certification services to patients under 18 years of age.

Recommendation # 6: The Medical Subcommittee recommended that more research be done on the use of medical marijuana for addiction treatment. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. The Secretary agrees that encouraging permittees to conduct research on the use of medical marijuana for addiction treatment is a top priority, particularly in light of the current opioid crisis. Research under Chapter 20 of the act will be designed to study the efficacy and utility of medical marijuana as medication for the serious medical conditions as defined by the act.

Recommendation # 7: The Patient/Caregiver Subcommittee recommended that the medical condition of ''Cancer'' be revised to ''Cancer; including remission therapy.'' The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. The Secretary agrees that patients who are in remission should have the same access to medical marijuana as those patients who are currently being treated for cancer.

Recommendation # 8: The Patient/Caregiver Subcommittee recommended that the medical condition of ''Neurodegenerative Diseases'' be added to the list of serious medical conditions. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. The Secretary agrees that persons with this condition could benefit from the use of medical marijuana as medical treatment or palliative care.

Recommendation # 9: The Patient/Caregiver Subcommittee recommended that the medical condition of ''Damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity'' be changed to ''Damage to the nervous tissue of the CNS (brain-spinal cord) with objective neurological indication of intractable spasticity, and other associated neurop-athies.'' The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. The Secretary agrees that broadening this condition will include additional persons who could benefit from the use of medical marijuana as medical treatment or palliative care.

Recommendation # 10: The Patient/Caregiver Subcommittee recommended adding the medical condition of ''terminally ill,'' meaning a medical prognosis of life expectancy of approximately 1 year or less if the illness runs its normal course. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. The Secretary agrees that terminally ill persons would benefit from the use of medical marijuana as palliative care.

Recommendation # 11: The Patient/Caregiver Subcommittee recommended adding the medical condition of ''Dyskinetic and Spastic Movement Disorders.'' The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. The Secretary agrees that persons with this condition would benefit from the use of medical marijuana as medical treatment or palliative care.

Recommendation # 12: The Patient/Caregiver Subcommittee recommended that the Department encourage Clinical Registrants under Chapter 20 of the act to study the medical benefits of cannabis for individuals with autoimmune diseases. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board. A Clinical Registrant, in conjunction with an academic clinical research center, conducting research under Chapter 20 of the act will be strongly encouraged to study the medical benefits of medical marijuana for patients with autoimmune diseases. The Department will be reviewing the research being conducted by clinical registrants prior to the start of the research.

Recommendation # 13: The Patient/Caregiver Subcommittee recommended adding the serious medical condition of ''Addiction substitute therapy—opioid reduction.'' The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. The Secretary recognizes the need for research in this area and that conventional therapies should be used unless those therapies are contraindicated or ineffective, or adjunctive therapy is indicated in combination with primary therapeutic interventions.

Recommendation # 14: The Medical Subcommittee, Patient/Caregiver Subcommittee and Regulatory Subcommittee recommended that the Program expand the form of medical marijuana permitted under the act of April 17, 2016 (P.L. 84, No. 16) to include dry leaf or plant form for administration by vaporization. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. Adding dry leaf and plant form, for administration by vaporization, to the forms permitted under the act will provide patients with greater access to medical marijuana because this form is the least costly. In addition, administration by vaporization is an avenue that allows patients to receive the benefit of medical marijuana much faster than other forms of administration, and the patient can better manage the dosage.

Recommendation # 15: The Regulatory Subcommittee recommended that the Program make no changes to the act concerning the number of growers/processors and dispensaries at present. The Program should assess the numbers as the Program expands. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. Amending the existing temporary regulations will allow for the issuance of additional permits as the Program expands and will give the Secretary, at least for the next 2 years while the temporary regulations are in place, greater flexibility to meet the need for Program expansion, particularly in response to a court order.

Recommendation # 16: The Patient/Caregiver Subcommittee recommended allowing dispensaries to purchase vaporizing devices and other ancillary products from sources other than grower/processor permittees. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees with the Board's recommendation. No further action needs to be taken to implement this recommendation; the temporary regulations currently provide for dispensaries, with the prior written approval of the Department, to sell, offer for sale or provide at a facility, instruments, devices and services related to the use of medical marijuana products. Allowing dispensaries to purchase these products from sources other than grower/processor permittees will increase competition and presumably lower prices. Also, growers/processors are in the business of growing and processing medical marijuana, not necessarily ancillary or other medical marijuana-related products. For the sake of efficiency and economy in the Program, growers/processors should focus on their primary function.

Recommendation # 17: The Patient/Caregiver Subcommittee recommended that the certification to use medical marijuana be modified to limit the practitioner's ability to specify medical marijuana form and dosing. The Board rejected the recommendation.

Secretary's Rationale: The Secretary agrees with the Board's recommendation that allowing a practitioner's ability to specify medical marijuana form and dosing should not be limited. It is within the practitioner's scope of practice to make these determinations regarding their patients, and the Department should not interfere with a licensed health care professional's exercise of his own professional judgment.

Recommendation # 18: The Patient/Caregiver Subcommittee recommended establishing a default time period of 1 year on a patient's certification. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees with this recommendation to the extent that a patient may incur additional identification card application fees during a 12-month period, because of a new or revised patient certification, which can be costly for a patient. The temporary regulations will be amended to effectuate this recommendation.

Recommendation # 19: The Medical Subcommittee and Patient/Caregiver Subcommittee recommended that practitioners have the option to opt-out of the public registry. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. The Secretary recognizes that physicians who might otherwise register as practitioners have declined to do so because of concerns that their practices might be negatively impacted. Lack of available practitioners could negatively impact patients with serious medical conditions who are in need of this important medical option. The temporary regulations will be amended to clarify that the practitioner registry is available to registered patients and caregivers who are utilizing it to obtain medical marijuana.

Recommendation # 20: The Medical Subcommittee, Patient/Caregiver Subcommittee and Regulatory Subcommittee recommended permitting medical marijuana to be dispensed in dry leaf or plant form, for administration by vaporization. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. See the rationale given for Recommendation # 14.

Recommendation # 21: The Medical Subcommittee, Patient/Caregiver Subcommittee and Regulatory Subcommittee recommended permitting medical marijuana to be dispensed in dry leaf or plant form for administration by vaporization. The Board adopted the recommendation.

Secretary's Rationale: The Secretary agrees and will effectuate this recommendation from the Board by amending the existing temporary regulations. See the rationale given for Recommendation # 14.

 Interested persons are invited to submit written comments, suggestions or objections regarding this notice to John J. Collins, Office of Medical Marijuana, Department of Health, Room 628, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120, (717) 547-3047, RA-DHMedMarijuana@pa.gov.

 Persons with a disability who wish to submit comments, suggestions or objections regarding this notice or who require an alternative format of this notice (for example, large print, audiotape or Braille) may do so by using the previously listed contact information. Speech and/or hearing-impaired persons may call the Pennsylvania AT&T Relay Service at (800) 654-5984 (TDD users) or (800) 654-5988 (voice users).

RACHEL L. LEVINE, MD, 
Secretary

[Pa.B. Doc. No. 18-747. Filed for public inspection May 11, 2018, 9:00 a.m.]



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