935 CMR, § 501.010

Current through Register 1536, December 6, 2024

Section 501.010 - Written Certification of a Debilitating Medical Condition for a Qualifying Patient

(1) A Certifying Healthcare Provider shall complete a program that explains the proper use of Marijuana, including side effects, dosage, and contraindications, including with psychotropic drugs, as well as on substance abuse recognition, diagnosis, and treatment related to Marijuana, which includes, but is not limited to, the following:

(a) A Certifying Physician issuing a Written Certification shall have completed a minimum of 2.0 Category 1 continuing professional development credits as defined in 243 CMR 2.06(6)(a)1.

(b) A Certifying CNP issuing a Written Certification shall have completed a minimum of one program meeting the requirements of 244 CMR 5.00: Continuing Education and 244 CMR 6.00: Approval of Nursing Education Programs and the General Conduct Thereof.

(c) A Certifying Physician Assistant issuing a Written Certification shall have completed a minimum of one program meeting the requirements of 263 CMR 3.05(3).

(2) A Certifying Healthcare Provider shall issue a Written Certification that complies with generally accepted standards of medical practice including, but not limited to, the following:

(a) A Certifying Physician issuing a Written Certification shall comply with generally accepted standards of medical practice, including regulations of the Board of Registration in Medicine at 243 CMR 1.00 through 3.00, pursuant to M.G.L. c. 112, § 5, and M.G.L. c. 111, § 203.

(b) A Certifying CNP issuing a Written Certification shall comply with generally accepted standards of nursing practice, including the regulations of the Board of Registration in Nursing at 244 CMR 9.00: Standards of Conduct.

(c) A Certifying Physician Assistant issuing a Written Certification shall comply with generally accepted standards of practice for physician assistants, including regulations of the Board of Registration of Physician Assistants at 263 CMR 5.09: Standards of Conduct for Physician Assistants.

(3) A Certifying Healthcare Provider may not delegate to any other healthcare professional or any other person, authority to diagnose a patient as having a Debilitating Medical Condition.

(4) A Certifying Healthcare Provider shall have a program to provide a discount to patients with documented Verified Financial Hardship. The plan shall outline the goals, programs, and measurements the Certifying Healthcare Provider will pursue as part of the plan. A Certifying Healthcare Provider may apply for a waiver under 935 CMR 501.850 to waive this requirement by demonstrating that the Certifying Healthcare Provider does not have control over the costs to its patients.

(5) A Certifying Healthcare Provider may issue a Written Certification only for a Qualifying Patient with whom the healthcare provider has a Bona Fide Healthcare Provider Patient Relationship.

(6) Before issuing a Written Certification, a Certifying Healthcare Provider shall utilize the Massachusetts Prescription Monitoring Program, unless otherwise specified by the Commission, to review the Qualifying Patient's prescription history.

(7) A patient who has had a diagnosis of a Debilitating Medical Condition in the past, but does not have an active condition, unless the symptoms related to such condition are mitigated by Marijuana for medical use, and is not undergoing treatment for such condition, is not suffering from a Debilitating Medical Condition for which the medical use of Marijuana is authorized.

(8) An initial or renewal Written Certification submitted before a Clinical Visit is prohibited.

(a) A Clinical Visit may occur in-person or by telehealth means, provided that a Clinical Visit for issuing an initial Certificate of Registration must be conducted in-person or, upon request of the patient, via a telehealth visit that includes a synchronous face-to-face encounter between the Certifying Healthcare provider and patient. Synchronous telehealth happens in live, real-time settings where the patient interacts with a provider, usually via phone or video.

(b) If a Clinical Visit is conducted by telehealth means, the Certifying Healthcare Provider shall ensure that there is an ability to deliver the service using telehealth with the same standard of care and in compliance with licensure and registration requirements as is applicable to in-person services to patients and shall comply with any additional requirements established by the Commission.

(9) A certification shall indicate the time period for which the certification is valid, and may not be less than 15 calendar days or longer than one year, except that in the following circumstances, the certification may be valid for two years:

(a) A Certifying Healthcare Provider verifies and represents to the Commission that a Qualifying Patient is receiving Social Security Disability Insurance or Supplemental Security Income; or

(b) A Certifying Healthcare Provider diagnoses a Qualifying Patient after an in-person Clinical Visit with a terminal illness, or permanent disability and certifies the patient for two years.

(10) A Certifying Healthcare Provider may determine and certify that a Qualifying Patient requires an amount of Marijuana other than 2.5 ounces as a 14-day Supply or ten ounces as a 60-day Supply and shall document the amount and the rationale in the medical record and in the Written Certification. For that Qualifying Patient, that amount of Marijuana constitutes a 14-day Supply or 60-day Supply.

(11) A Qualifying Patient who is younger than 18 years old and has been diagnosed by two Massachusetts licensed Certifying Physicians, at least one of whom is a board certified pediatrician, pediatric subspecialist, oncologist, neurologist, or family physician, with a debilitating Life-limiting Illness, may receive a Written Certification; provided however, that the physicians may certify a Qualifying Patient who is younger than 18 years old who has a Debilitating Medical Condition that is not a Life-limiting Illness if those physicians determine that the benefits of the medical use of Marijuana outweigh the risks. This shall include a discussion of the potential negative impacts on neurological development with the parent or legal guardian of the Qualifying Patient, written consent of the parent or legal guardian, and documentation of the rationale in the medical record and the Written Certification.

(12) A Certifying Healthcare Provider, and such healthcare provider's co-worker, employee, or Immediate Family Member, may not:

(a) Have ever directly or indirectly accepted or solicited from, or offered to an MTC, a board member or Executive of an MTC, any MTC personnel, or any other individual associated with an MTC, or a Personal Caregiver, anything of value;

(b) Offer a discount or any other thing of value to a Qualifying Patient based on the patient's agreement or decision to use a particular Personal Caregiver or MTC;

(c) Examine or counsel a patient, or issue a Written Certification, at an MTC;

(d) Be a Person or Entity Having Direct or Indirect Control for an MTC; or

(e) Directly or indirectly benefit from a patient obtaining a Written Certification, which may not prohibit the healthcare provider from charging an appropriate fee for the Clinical Visit.

(13) A Certifying Healthcare Provider may not issue a Written Certification for himself or herself or for his or her Immediate Family Members.

(14) A Certifying Healthcare Provider issuing a Written Certification for their employees or coworkers shall do so in accordance with 935 CMR 501.010 of a Debilitating Medical Condition for a Qualifying Patient, including conducting a Clinical Visit, completing and documenting a full assessment of the patient's medical history and current medical condition, explaining the potential benefits and risks of Marijuana use, and maintaining a role in the ongoing care and treatment of the patient.