November 9, 2010 Medical Marijuana Advisory Committee Colorado Department of Public Health and Environment 4300 Cherry Creek Drive South Denver, CO 80246-1530 Re: Medical Morijuana Registry Rulemaking Dear Members of the Medical Marijuana Advisory Committee, The Colorado Medical Society appreciates the opportunity to provide input on the enactment of rules governing the medical marijuana registry program. Rules to Clarify “in Good Standing” ‘As expressly defined by statute “in good standing” means that the physician holds a degree of MD or DO from an accredited medical school; has a valid and unrestricted license; and has a valid an unrestricted DEA registration.’ A concern has been expressed that the language does not include physicians who have conditional licenses (e.g. a probationary license with CPHP monitoring). Accordingly, there is a proposal to define “in good standing” to mean a license that “is not restricted and/or conditioned in any way.” For the reasons outlined below, CMS requests that such change not be made by rule. ‘The Medical Board recognizes the following classifications for medical license status: - Active - Rescinded = Active - With Conditions = Revoked - Active—Restricted - Surrendered - Expired = Surrendered - With Conditions - Inactive - Suspended - Lapsed = Suspended - With Conditions - Lapsed - With Condi CRS §25-1.5-106(2)(c).Notably, a restricted license in Colorado is classified as having an “Active — Restricted” status. A review of licenses classified as “Active ~ Restricted” status demonstrate that the status limits a physician’s practice by preventing the physician from performing the full scope of medical practice. In other words, the status “restricts” the physician’s medical license to a defined scope. In contrast, a license that Is “Active - With Conditions” has no such limit or restriction. Rather, such licenses require physicians to satisfy certain “conditions” (often including complying with recommendations of the Colorado Physician Health Program or the Center for Personalized Education for Physicians). These conditions, however, are not viewed as changing a physician’s license status to “restricted.” Confiating the status of a restricted license with that of a conditional license has significant downstream legal implications. The issue of whether a license is “restricted” or “in good standing” is important in several contexts, including: - Employment Contracts and Practice Ownership. Most physician employment contracts require that physicians maintain certain qualifications including, among other things, an “unrestricted” license “in good standing.” Failure to maintain required qualifications i cause for termination, which then may allow for a buy-out of medical practice ownership interests. - Board Certification and Hospital Privileges. Many specialty boards have enacted policies that require physicians to have an “unrestricted,” “unlimited,” or “full” license that is “in good standing.” For example, the American Board of Family Medicine has a Policy requiring physicians to maintain a license that is “active, valid, full, unrestricted and not limited” to be certified. In turn, physicians are often required to be Board Certified to maintain admitting privileges at hospitals. - Payor Panel Status. Third party payors often require physicians on their panel to maintain an unrestricted license in good standing. - Public Entity Employment. Many public entities such as the Veteran's ‘Administration and the Indian Health Service are prohibited by regulation from employing a physician who has a “restricted” license. Hence, an interpretation of law that a license with conditions is somehow no longer a license in good standing or is a restricted license may cause significant unintended consequences.Importantly, under the Colorado Administrative Procedures Act, no agency may adopt a rule unless: 0} ‘The record of the rule-making proceeding demonstrates the need for the regulation; (ll) The proper statutory authority exists for the regulation; (Il!) Tothe extent practicable, the regulation is clearly and simply stated so that its meaning will be understood by any party required to comply with the regulation; (IV) The regulation does not conflict with other provisions of law; and (V)__ The duplication or overlapping of regulations is explained by the agency proposing the rule.” As athreshold matter, itis important to ask whether all physicians who have a conditional license should be automatically classified as restricted and not in good standing. Notably, health care providers who have a history of substance abuse may be allowed to prescribe controlled substances for patients — even the substances they have a history of abusing. This is because they are monitored by Board- approved programs for safety. If there is a particular concern about an individual physician’s prescribing, the Medical Board may restrict the physician's license (e.g. the physician is not allowed to prescribe certain substances). Here, if the Board has a specific concern about a physician related to marijuana certifications, the Board can limit that individual physician. A blanket rule, however, that defines all licenses that are active with conditions to be a license that is “restricted” or not “in good standing” has the potential for many unintended consequences without being targeted to specific physicians. Rules Relating to “Bona Fide Physician-patient Relationships” The statute is clear that a physician must have a “Bona fide physician-patient relationship” to certify a patient for medical marijuana. The statute further defines such a relationship to mean that: ()) Aphysician and a patient have a treatment or counseling relationship, in the course of which the physician has completed a full assessment of the patient's ‘medical history and current medical condition, including an appropriate personal physical examination; (i!) The physician has consulted with the patient with respect to the patient's debilitating medical condition before the patient applies for a registry identification card; and CRS §24-4-103(4)(b).{lll) The physician is available to or offers to provide follow-up care and treatment to the patient, including but not limited to patient examinations, to determine the efficacy of the use of medical marijuana as a treatment of the patient's debilitating medical condition.> The statute provides for referral of physicians who violate these requirements to the Medical Board. The Medical practice Act, in turn, allows the Board to discipline a provider who fails to comply with the constitutional, statutory, or regulatory requirements related to certifications.”* The statute itself provides significant direction about appropriate physician-patient relationships. Accordingly, the Medical Society suggests that only minimal clarification is required through rulemaking. This is particularly important in light of the fact that even though the proposed rules are related to the medical marijuana program, regulatory interpretations of physician-patient relationships may be applied elsewhere. Consequently, the Medical Society is cautious in this area, Nonetheless, because the statute references use of the registry to determine whether a physician should be referred to the Medical Board for discipline, the Medical Society believes that the following clarifications should be part of the Committee’s proposed rules: - An appropriate “personal physical examination” cannot be conducted by telemedicine or any other remote means, accordingly certifications done by remote means, including telemedicine will be referred to the Medical Board. = Statutory requirements that a certifying physician “have a treatment or counseling relationship” with the patient; has consulted with the patient regarding “the patient's debilitating medical condition before the patient applies for a registry identification card;” and is available “for follow-up care” contemplates established, ongoing relationships. Accordingly, certifications ‘completed outside a regular and permanent practice location or licensed health care facility will be referred to the Medical Board. ~ Finally, all rules should ensure that use of the registry for referral of a physician to the Medical Board should be applied consistently according to written criteria. For example, the Agency could follow the Medical Board model, which is complaint driven; and/or the rules could provide that the registry be surveyed/audited related to specific criteria. CRS §25-1.5-106(2}(a). RS §12-36-117(1 mm).Il. Revoking or Suspending the Ability to Certify ‘The statute is clear that physicians are restricted from: ~ Having a financial relationship with caregivers and distributors; - - From incentivizing patients to use a particular caregivers or distributor; - Certifying patients at the location where marijuana is sold or distributed; or ~ Owning an interest in a distributing entity. The statute provides that the Agency may conduct a hearing related to such Violations and may impose sanctions if violations are found. Again, the Medical Society suggests that rulemaking in this regard focuses on consistent triggers causing. the Agency to initiate the hearing process. Following the Medical Board complaint driven model, or consistently performed audits of certifications for the certifying location seem appropriate. We look forward to answering any questions or concerns about these issues at the upcoming meeting on November 10, 2010. In the interim, if you have any questions or concerns, please do not hesitate to calll. Sincerely, “Vie ae Diana Protopapa Colorado Medical Society Hos. HMaddeg Kari Hershey Legal Counsel