18-691-2 Me. Code R. § 4

Current through 2024-29, July 17, 2024
Section 691-2-4 - MEDICAL PROVIDER WRITTEN CERTIFICATION
A.Authorized conduct by a medical provider; written certification. Prior to issuing a written certification, the medical provider shall certify that it is the provider's professional opinion that the patient is likely to receive therapeutic benefit from the medical use of marijuana to treat or alleviate the patient's debilitating medical condition. Medical providers issuing written certification to qualifying patients must comply with this rule and the statute. Remote healthcare services for the purposes of the certification and treatment monitoring related to marijuana for medical use are not prohibited by this rule.
1.Department-approved certification process. The qualifying patient's medical provider shall use the Department-approved certification process to issue a written certification for a qualifying patient's medical use of marijuana for at least one of the debilitating medical conditions or treatments listed in statute or approved pursuant to this rule. The medical provider shall give the original signed and dated written certification directly to the qualifying patient or patient's legal guardian.
a.Certification for minor qualifying patients. When a list of physicians known to the Department to be willing to act as a consulting physician is not available, the Department will permit the inquiring treating medical provider to proceed with the certification process for a minor qualifying patient at the time of the request.
b.Replacement written certifications. Except when it is determined to be medically necessary to examine the qualifying patient, a medical provider may, without an in-person encounter with the patient, re-print a written certification if the qualifying patient's certification has been lost or needs updated patient information. When the medical provider does not complete a full assessment of the patient, the expiration of the replacement written certification must not exceed the expiration date of the preceding lost or inaccurate written certification.
2.Referral to professional licensing boards. The Department may refer to the appropriate professional licensing board a report received regarding the medical provider's inappropriate evaluation or treatment of a patient's medical condition or a reported alleged violation of the applicable standard of care, or when the Department determines the medical provider has violated this rule or the statute.
3.Medical provider compliance. The medical provider must remain in good standing with professional licensing authorities and compliant with this rule and the statute to avoid interruption in the provider's capacity to issue written certifications.
B.Public petitions: adding debilitating medical conditions. The Department shall consider written public petitions to add a disease or medical condition to the list of debilitating medical conditions set forth in statute for the medical use of marijuana. A petition to benefit an individual patient on whose behalf the petition is submitted that does not comply with the provisions in this section shall be denied by the Department.
1. A petition to add a disease or medical condition must be submitted on forms provided by the Department.
2. The petition must clearly identify the specific debilitating disease or medical condition.
3. The petition must include reputable scientific evidence that supports the use of marijuana for the treatment of the disease or medical condition.
4. The petition must include sufficient evidence to demonstrate that the medical use of marijuana would benefit qualifying patients with the disease or medical condition.
5. The petition must include sufficient evidence that marijuana therapy is effective enough to warrant its use.
6. The petition must include written endorsement from a Maine medical provider, as defined in statute.
C.Public hearing. The Department shall publish a notice indicating the date, time and place of the public hearing on the petition. The notice shall be posted on the Department's webpage and electronically sent to individuals who contact the Department to be placed on the Department's interested parties' mailing list.
D.Written comments. The Department shall accept written comments on the petition for ten business days after the date of the public hearing.
E.Commissioner's decision. The commissioner shall approve or deny a petition within 180 days of its submission. The commissioner's written decision shall include the factors supporting the decision. Factors considered by the commissioner include, but are not limited to, the following:
1. The written petition including required documentation;
2. Public testimony and written comments; and
3. Consultation with physicians and additional research conducted by, or on behalf of, the Department at its discretion.
F.Bona fide medical provider-patient relationship. The medical provider shall certify that the written certification has been provided in the course of a bona fide medical provider-patient relationship. The medical provider may have to verify that, prior to issuance of a written certification, a bona fide medical provider-patient relationship exists. In order to establish a bona fide medical provider-patient relationship for medical marijuana certification, the medical provider shall:
1. Conduct a full assessment of the patient's medical history, including substance misuse history and current condition, medication and treatment;
2. Facilitate an encounter with the person and conduct a relevant physical examination occurring at a permanent location that, similar to a covered office visit or outpatient treatment in terms of site, extent, duration and frequency; is clinically appropriate for conducting medical services and effective for addressing the patient's debilitating condition; and that enables the patient to return for follow up, consultation or assistance, as needed;
3. Review of prior records of relevant examinations, diagnostic test results, treatments and treatment response;
4. Develop and document a plan of care;
5. Create and maintain patient records and documentation, including:
a. The patient's medical history;
b. Results of the physical examination, including vital signs, and any laboratory tests;
c. Instructions to the patient, including discussions of the risks and benefits of the medical use of marijuana, and any disadvantages, alternatives, potential adverse effects, and expected response to treatment;
d. A description of the treatment(s) provided to the patient, including all past and current medications prescribed or administered (including the date, type, dose and quantity);
e. Results of ongoing monitoring of patient progress and the need for the continued use of medical marijuana; and
f. Notes on evaluations, communications and consultations with other medical providers.
G.Retain and maintain records. The medical provider must-retain and maintain records that support the decision to recommend the medical use of marijuana, including records of the diagnosis of the debilitating medical condition for which the medical use of marijuana is recommended, including:
1. A description of the ordinary medical or surgical measures for intractable pain that the patient has not responded to for more than six months; or
2. A description of the symptoms resulting from a chronic or debilitating disease or medical condition or its treatment that satisfies criteria for the medical use of marijuana as set out in this rule and the statute; and
3. A nonbinding estimate of the length of time that the medical use of marijuana is needed for the treatment of the debilitating medical condition.
H.Minor patient; consent. Prior to issuing a written certification for a minor patient's medical use of marijuana, the treating medical provider must secure written consent of the parent, legal guardian, or person having legal custody of the minor qualifying patient. The medical provider must have documentation of the consent of the parent, legal guardian or person having legal custody of the minor in accordance with the statute.
I.Incapacitated adult patient consent. Prior to issuing a written certification for an incapacitated adult patient's medical use of marijuana the medical provider must secure written consent that includes the following written documentation from the legal guardian or the power of attorney for health care of the incapacitated adult qualifying patient. The incapacitated adult patient's legal guardian or the power of attorney for health care must:
1. Consent to the patient's medical use of marijuana;
2. Consent to serve as one of the patient's primary caregivers;
3. Consent to control the acquisition of marijuana, and the dosage and frequency of the medical use of marijuana by the incapacitated adult patient; and
4. Consent to comply with all other applicable provisions of this rule and the statute.
J.Proof of authority to act for another. The legal guardian or the power of attorney for health care of an incapacitated adult patient, or a minor's guardian or the person having legal custody of the minor must submit to the treating medical provider a copy of the legal documentation issued by the court that appointed the guardian, a copy of the incapacitated adult patient's power of attorney for health care or other legal documentation that the person has legal custody of the patient.

18-691 C.M.R. ch. 2, § 4