Rules and Regulations Related to the Medical Marijuana Program Administered by the Department of Health [R21-28.6-MMP]

Regulation Authority:

RIGL Chapter 21-28.6

Purpose and Reason:

Statement of Purpose: The proposed regulations update standards for the implementation of the medical marijuana program and other changes mandated pursuant to PL 2014-515, PL 2014-145, Article 15 § 3, PL 2016-415, PL 2016-142, Article 14. Summary of Comments and Rhode Island Department of Health (RIDOH) Responses: The RIDOH reviewed the comments received during the public comment period, including written, emailed, and the public hearing transcript. The RIDOH is limiting its summary to the comments received regarding the RIDOH’s proposed regulations. Its summary does not include comments received concerning the Rhode Island Department of Business Regulation’s (DBR’s) proposed regulations. 1. Commentary was received stating concerns about the RIDOH’s statutory authority to provide background check. RIDOH Response: These concerns were considered by RIDOH’s legal counsel and rejected, as the RIDOH interprets RIGL § 21-28.6-6 (e) (1) to provide sufficient legal authority. 2. Testimony was received requesting the RIDOH for “safe harbor access” to test for pesticides and fungicides in the state of Massachusetts. RIDOH Response: The RIDOH laboratory testing requirements will be addressed separately through a second set of RIDOH regulations. The RIDOH anticipates that these regulations will be available for public comment in early 2017. These regulations will also include requirements related to dosage. 3. Commentary was received expressing concerns about expedited applications for chemotherapy and hospice patients. Specifically, it was noted that PL 2016-415 (H-7142) states that patients who are eligible for hospice care qualify for expedited applications. Further, the statute states that patient and caregiver registration fees for such patients be waived. RIDOH Response: The RIDOH is in the process of changing its application to state “patient is eligible for hospice,” and that there is no fee for such patients and their caregivers. Currently, if a physician checks “patient is in hospice”, the RIDOH expedites the application. When the RIDOH receives an application from a hospice patient and/or caregiver of a hospice patient, the RIDOH sends the check back to the patients with an explanation that there is no fee. 4. Commentary was received regarding the requirement that “primary caregivers” be Rhode Island residents. RIDOH Response: The RIDOH declines to make any changes in response to this commentary because the RIDOH does not have authority to regulate any activities related to the marijuana program outside of the state of Rhode Island. Although as of January 1, 2017, primary caregivers who apply for registration must be a resident of Rhode Island, caregivers who received registrations prior to and including December 31, 2016 will be required to be a resident of Rhode Island when their registration is up for renewal. The statute includes this process to provide time for patients and caregivers to transition to the new residency requirement. 5. Testimony was received regarding requirements for written certifications to include a “copy of relevant medical records.” Clarification was requested as to what will constitute a “relevant medical record.” RIDOH Response: The RIDOH does not have the desire or capacity to request extensive medical records. The RIDOH will describe what a “relevant medical record” is on its application and relevant guidance documents. In essence, however, the RIDOH will expect to receive the physician’s medical note or statement that captures the patient’s qualifying medical condition. The RIDOH will reserve the right to, on a case by case basis, request additional information which will be reviewed by a RIDOH physician. The RIDOH has longstanding experience and expertise managing confidential health care information for numerous public health programs. 6. Testimony and commentary were received regarding the sections of the proposed regulations describing practitioner responsibilities. It was noted that the requirements are burdensome and might cause physicians to refuse to sign renewal applications and/or participate in the program. Concerns about the CME requirements for physicians as well as semi-annual follow-up appointments were specifically raised. RIDOH Response: The RIDOH will give due deference to the physician’s determinations for treatment and follow-up of a qualifying debilitating medical condition as defined in RIGL § 21-28.6-3 (5). The requirements, including the requirement for semi-annual follow-up, reflect common practice when prescribing medication to a patient and represent a minimum standard. Physicians have a duty to educate patients. If a patient has not tried other therapies, then simply documenting no prior therapy in the patient’s medical record is appropriate. Medical marijuana patients should receive the same level of care as other patients which includes but is not limited to presenting complaint; history of present illness; review of systems; and past family, medical and social history; and physical examination. The CME requirements address known lack of training physicians receive on the use of medical marijuana. Traditional training focuses on marijuana primarily as a substance of abuse. The CME requirement will improve patient care. 7. Commentary was received requesting wording in § 7.1 of the RIDOH’s proposed regulations to reflect the confidentiality protection wording in the statute. RIDOH Response: The RIDOH declines to change this wording as the protections listed in § 6 and 7 of the proposed regulations provide for adequate confidentiality protections. 8. Testimony was received requesting the inclusion of wording to strengthen patient protection from discrimination related to employment. RIDOH Response: The RIDOH declines to incorporate this request since the issue is outside the scope of RIDOH’s authority. 9. Commentary was received regarding the affordability fees for patients, caregivers and authorized purchasers. RIDOH Response: RIGL § 21-28.6-5 provides the RIDOH with the authority vary the application and renewal fees along a sliding scale that accounts for a qualifying patient's or caregiver's incomes. The RIDOH will address affordability concerns on a case by case basis. Change(s) in Regulation(s) Based on Submitted Comments: None. It is the RIDOH’s assessment that the comments we received were informative but did not identify substantial issues which would preclude promulgation of the proposed regulations. The RIDOH seeks to reflect changes in its application and other policies that do not require regulatory amendment. Proposed Next Step(s): The RIDOH intends to File Rules and Regulations Related to the Medical Marijuana Program Administered by the Department of Health [R23-28.6-MMP] and the related Rules and Regulations Pertaining to The Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health [R23-1-17-FEE] as proposed.