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| Montana Administrative Register Notice 24-111-28 | No. 16 08/25/2023 | |
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BEFORE THE ALTERNATIVE HEALTH CARE BOARD DEPARTMENT OF LABOR AND INDUSTRY STATE OF MONTANA
TO: All Concerned Persons
1. On June 23, 2023, the Alternative Health Care Board (board) published MAR Notice No. 24-111-28 regarding the public hearing on the proposed changes to the above-stated rules, at page 542 of the 2023 Montana Administrative Register, Issue No. 12.
2. On July 14, 2023, a public hearing was held on the proposed changes to the above-stated rules via the videoconference and telephonic platform. Comments were received by the deadline.
3. The board has thoroughly considered the comments received. A summary of the comments and the agency responses are as follows:
COMMENT 1: One commenter suggested the board consider allowing direct-entry midwives to provide primary care to a woman whose pregnancy is considered high-risk simply due to the mother's age so long as the mother is otherwise in good health and/or if the care is approved by a physician.
RESPONSE 1: Age alone is not sufficient to make a pregnancy high risk, and this condition is already addressed in ARM 24.111.611(1)(a)(xxv).
COMMENT 2: One commenter noted that there appears to be an error on the dosage for lidocaine in NEW RULE III, which states that the maximum dosage should be 2% with a maximum dose of 50mL. The commenter notes that using this formula, 50cc of a 2% lidocaine solution is 1000mg, and the maximum lidocaine dosage is 300mL. The commenter requests the board change the dosage to either 10cc of 2% or 20cc of 1%.
RESPONSE 2: The board agrees and will adjust the dosage as suggested.
COMMENT 3: One commenter suggested the board consider requiring pharmacology continuing education (CE) for midwives as a yearly requirement.
RESPONSE 3: The board considered this suggestion during the drafting process and determined the formulary is static and not changing, is covered in standard midwifery education, and in regular use. Mandating further education is not necessary at this time.
COMMENT 4: Several commenters stated the formulary committee had not met prior to the proposal being issued and suggested that was a violation of 37-26-201(8), MCA.
RESPONSE 4: The formulary committee met several times over the course of several years prior to the statutory change, based on ongoing expressed frustration between naturopathic physicians and pharmacists as to what prescribing was allowed. The formulary committee had extensive discussions regarding naturopathic education, training, and scopes of practice from neighboring states. In January of 2022, the formulary committee recommended amendments to the board that did not require a statute change, indicating the committee felt an exclusionary formulary was best, and would eliminate the confusion between naturopathic physicians and pharmacists on the ability of naturopaths to prescribe. The board took those recommendations, proposed and publicly noticed rules, and then after receiving and considering public comment, determined that a statute change was necessary to achieve the formulary committee's recommendations. Therefore, once the statute change had been accomplished, the board could proceed to institute the recommendations the committee had been recommending for several years. In regards to the suggested statutory violation, the board notes that the formulary committee is required to create the formulary and meet annually to suggest changes, which are required to be reviewed by the board and published as administrative rules. The formulary committee did create the formulary in 1998 as part of MAR Notice No. 8-4-11, and met to suggest changes to the full board since that time. The formulary committee met July 19, 2023, and submitted comment as part of this project that the proposed rule accurately reflected the work the committee had done and the recommendations the committee made to the board over the past several years.
COMMENT 5: One commenter objected to the lack of documentation of the formulary committee's work and proposed the board include results of conducted research as part of the rules notice.
RESPONSE 5: Formulary committee meetings were publicly noticed and included public discussion and input from anyone in attendance who wished to participate. Over the past several years, no public commenter has expressed concern about the committee's work. Committee discussions were recorded and remain available should anyone wish to listen to the meetings. The statute does not require a specific process for the committee to follow in evaluating curricula and CE. Therefore, committee members discussed their individual research, education, training, and CE opportunities on the record during the meetings and directed staff as a result of those discussions.
COMMENT 6: Several commenters noted that the formulary committee met during the comment period, suggested it was a rushed meeting, and suggested it could have provided greater insight into the concerns related to the formulary.
RESPONSE 6: The board publicly noticed the formulary committee meeting, in an abundance of caution relating to concerns expressed by the Economic Affairs Interim Committee, several days in advance of the committee meeting, and sent the notice to the board's interested parties list, as required by statute. Several members of the public attended, and only one offered public comment, which was in support of the board's proposal.
COMMENT 7: Multiple commenters believed the legislature intended to require all licensed naturopaths and applicants to take a competency exam in lieu of additional education.
RESPONSE 7: The legislature did not put any additional requirements into statute regarding existing licensees. The testing requirements for naturopathic doctors (ND) licensure in Montana have been in effect since the implementation of the license. Additionally, NDs have a CE requirement and have been prescribing safely since 1998. The existing competency exam is working well, along with the CE requirement.
COMMENT 8: Several commenters noted that the formulary committee had not reviewed curricula from naturopathic schools.
RESPONSE 8: Members of the formulary committee, who are graduates of naturopathic schools of medicine, indicated that their training included extensive pharmacology training and did not differentiate between natural and synthetic substances. The board also examined current curricula at accredited schools, determining that naturopathic physicians attend four years of rigorous education, with hundreds of hours of pharmacology education. Additionally, third-party accreditors regularly monitor naturopathic medical schools for compliance with standards. Further, the formulary committee considered neighboring states with similar education requirements for licensure, and their formularies in reaching its recommendations to the board.
COMMENT 9: Several commenters noted that this rulemaking seems rushed.
RESPONSE 9: The formulary committee has been working on this issue for years, including publicly noticed meetings where the public provided input and comments on the committee's work. Further, the legislature put an immediate effective date on Senate Bill (SB) 100, meaning that rulemaking had to be a priority for the board. The board further notes that at its publicly noticed May 2023 meeting, three members of the public attended. At its February 2023, publicly noticed meeting with discussion on SB 100, which had been introduced, four members of the public attended, and one made comment on SB 100. The board has had adequate opportunity for public comments during the legislative and rule drafting process, in addition to the extensive stakeholder input the department undertook before the board considered rule drafts.
COMMENT 10: Several commenters supported the formulary rule as proposed, stating the proposal is consistent with the work of the formulary committee over the previous three years, including discussions about education received in naturopathic medical school, pharmacological examination requirements, and CE opportunities.
RESPONSE 10: The board appreciates all comments received during the rulemaking process.
COMMENT 11: Several commenters stated they had received comprehensive pharmacology education as part of their naturopathic training.
RESPONSE 11: The board agrees with the commenters. See RESPONSES 8, 9, and 10.
COMMENT 12: Multiple commenters believed that the rule changes will bring Montana into line with what naturopathic physicians are allowed to prescribe in neighboring states.
RESPONSE 12: The board agrees that NDs in the region have similar education requirements and similar prescribing rights and have been doing so safely, thus filling a need in primary health care.
COMMENT 13: Several commenters stated that the restriction on prescribing drugs of a natural origin was 30 years old, and was meaningless, confusing, and arbitrary in the actual practice.
RESPONSE 13: The board notes that NDs have been legally authorized to prescribe medications for 30 years including legend drugs with specific limitations. The prescribing of legend drugs is not new for NDs.
COMMENT 14: One commenter noted this rules proposal was the result of multiple years of intense research, deliberations, and formulary committee work.
RESPONSE 14: The board agrees with the commenter. See RESPONSES 4, 5, 6, 7, 8, 9, and 10.
COMMENT 15: Multiple commenters opposed the proposal, stating that all providers need to demonstrate competency for prescribing medications, not just new applicants.
RESPONSE 15: The legislature did not put any additional requirements into statute regarding existing licensees. Further, all licensees have a professional obligation as part of their licensure to practice within the scope of their own education, training, and experience, and to meet the minimum levels of competency set by the legislature. The board expects licensees will seek out the training and education necessary to maintain competency in their practices. As stated in 37-26-102(1), MCA, "The legislature finds that a significant number of Montanans choose naturopathic medicine for their health care needs and declares that naturopathic medicine is a distinct health care profession that affects the public health, safety, and welfare and contributes to public freedom of choice in health care." Montana-licensed naturopathic doctors (NDs) are primary health care providers who diagnose and treat human health conditions, injuries, and diseases. See 37-26-103(7), MCA. Montana-licensed NDs must complete a comprehensive course of study at an approved four-year, accredited, graduate-level naturopathic medical school and pass a rigorous professional examination. See 37-26-402, MCA. Approved naturopathic medical colleges are graduate schools that are accredited by the Council on Naturopathic Medical Education (CNME) which is recognized by the U.S. Department of Education. NDs are educated in the same biomedical sciences as are MDs, and in addition, study clinical nutrition, physical medicine, pharmacology, botanical medicine, psychology, and counseling. This study includes over 4100 hours of total instruction with 1200 hours of hands-on clinical training and 100 hours of pharmacology. All ND students are training to become primary care physicians. ND students learn to recognize the symptoms of diseases that fall outside of their scope of practice and refer patients to specialists as appropriate. While some practicing NDs do expand their education and develop specialty areas, the focus of naturopathic medical school is identifying and treating diseases that fall within the realm of general practice. Pharmacology education is required for all ND students. Accredited naturopathic medical schools provide instruction on basic principles of pharmacology including clinical indications, pharmacokinetics (to include absorption, distribution, metabolism, and excretion of drugs), pharmacodynamics (including dose-receptor interactions and dose response relationships), mechanisms of action, and the chief side effects and toxicity of prototypical drugs of each of the major contemporary drug classes. Students are expected to be able to predict the chief therapeutic effects and chief side effects. In specialty courses such as cardiology, gastroenterology, gynecology, and endocrinology, students are taught the therapeutic options for specific conditions and trained in the broadest national scope of practice for an ND which includes both naturopathic and allopathic care including surgical and pharmacological options. Practicing NDs see many patients daily who have pharmaceutical medications already in place, and they must interface with the clinical implications, indications, contraindications, side effects, and potential toxicity of the medications that cover all realms of practiced medicine and specialty areas. The Naturopathic Physicians Licensing Exam (NPLEX), required for licensure, tests applicants' knowledge of pharmacology. Specifically, Part II of the NPLEX, the Core Clinical Science Examination, is a case-based, integrated test of clinical competency and is designed to measure a graduate's readiness to practice naturopathic medicine, assessing mastery of the competencies derived from a job analysis of practicing naturopathic physicians and specifically requires knowledge of medical conditions and diagnosis, lab tests and diagnostic imaging, botanical medicines, and pharmacology of all major classes of commonly prescribed drugs including; primary actions, adverse effects, indications, contraindications, and potential interactions with botanical medicines, nutritional supplements, and other pharmaceuticals; natural therapeutic interventions having effects similar to commonly prescribed pharmaceuticals; and to monitor therapeutic drug levels and assess for toxicity. NDs are licensed in 23 states and three U.S. territories and have prescribing rights in 15 states. The Drug Enforcement Administration (DEA) grants DEA numbers to licensed NDs with prescribing authority. Neighboring states where NDs are licensed, including Idaho, Washington, and Oregon, recognize the education and training of NDs, do not restrict the prescribing authority of licensed NDs, and in the state of Oregon have done this safely for over 20 years. In addition, Montana-licensed NDs are required to complete at least five hours of CE in pharmacology annually, which is a third of the required CE for license renewal. See ARM 24.111.2102. Montana-licensed NDs are well educated in pharmacology.
COMMENT 16: Multiple commenters referenced an agreement reached during the legislative session to require all licensees to pass a competency examination, drawing attention to the board's stated reason of "the Legislature requested the board consider requiring specific pharmacology education of licensees new to practicing in Montana" and requests the board honor an agreement made to require passage of a test.
RESPONSE 16: SB 100 does not reference a competency exam for existing licensees, nor did the bill sponsor insert one. Licensees are expected to maintain competency in their practice, and not every licensee will choose to prescribe the drugs allowed by the formulary. The bill sponsor was provided with the rule proposal notice and responded that it "looks good." The board is unaware of and was not party to any agreements reached during the session and notes that those agreements are not in the bill as passed. See also RESPONSE 15.
COMMENT 17: Multiple commenters believed the board is not protecting patients by not requiring a competency examination of all licensees.
RESPONSE 17: All Montana-licensed NDs are highly trained and are required to take a rigorous exam, the NPLEX II. Please refer to RESPONSE 15 for further detail about the required education and training for all Montana licensed NDs. Further, the training NDs receive has carried the ability to prescribe more medications than what has been allowed in Montana law for the last 30 years. See also RESPONSES 15, 16, and 17.
Comment 18: One commenter suggested the board require educational programs that cover the drugs on the formulary list.
RESPONSE 18: The board notes that formal educational programs required for licensure do address pharmacology, and that each naturopathic physician is required to complete pharmacology as part of the yearly CE process. Please see RESPONSES 15 and 17.
COMMENT 19: One commenter expressed concern about the breadth of training and understanding specific to antineoplastic medications and suggested the board consider requiring more training before allowing NDs to prescribe.
RESPONSE 19: NDs are trained as primary care providers. Training includes knowing when to refer out, including to specialists, just like any other primary care provider. NDs are limited to topical or oral prescriptions only, and the medications referenced by the commenter have been on the formulary list for years.
COMMENT 20: One commenter requested the board consider requiring training on synthetic opioid prescribing as well.
RESPONSE 20: Naturopathic physicians have been able to prescribe opioids since 1998, when the first formulary was created. Many NDs choose to carry a DEA license, which requires additional oversight. The DEA is now requiring opioid specific training for every licensee. NDs can prescribe Schedules II-V and have for years without issue. NDs are required to use the MPDR as part of their practice. In addition, as of June 2023, the DEA requires all new and renewal applicants for a DEA license to take eight credit hours of training regarding the treatment and management of patients with opioid or other substance use disorders. All NDs who carry or apply for a DEA license will fall under this requirement.
COMMENT 21: Multiple commenters objected to naturopaths being allowed to prescribe opioids.
RESPNONSE 21: Naturopathic physicians were able to prescribe opioids prior to this rulemaking process. See RESPONSE 20.
COMMENT 22: Several commenters suggested the board insert a CE requirement for naturopathic physicians to complete education in pharmacotherapeutics.
RESPONSE 22: The board has an existing requirement that all licensed NDs complete five hours of CE in pharmacology for every renewal cycle. The board does not see the need to insert additional requirements, expecting that licensees will choose CE relevant to individual practices and necessary for the competent practice of each licensee.
COMMENT 23: Several commenters suggested the board consider a tiered approach to allowing naturopathic physicians to prescribe synthetic drugs once the naturopathic physicians have demonstrated competency.
RESPONSE 23: The board determined the tiered approach is unnecessary, and that naturopathic licensees will continue to provide care that is within the scope of their education, training, and experience. Naturopathic licensees have been prescribing complex medications for years with few issues. See RESPONSE 15.
COMMENT 24: One commenter asked the board to consider a waiver of competency testing in addition to competency testing requirements.
RESPONSE 24: The board concludes that a waiver is unnecessary, as there is no requirement for competency testing. See RESPONSES 15, 17, and 18.
COMMENT 25: Several commenters asserted that the proposed Clinical Elective Pharmacology Examination in ARM 24.111.502 is not sufficient to establish competency, as it was first introduced in August of 2017.
RESPONSE 25: The board is comfortable that the exam is sufficient to establish competency. The test is a psychometrically developed and recognized exam in the practice of naturopathic medicine that covers, as the commenters noted, both legend and natural medications. Further, the board noted, states with similar laws governing the practice of naturopathic medicine utilize this test. The NPLEX II core clinical exam has always contained and tested core clinical pharmacology in all major pharmacology classes and maintains doing so. The new elective exam does not minimize in any way the standard core clinical exam as it sufficiently covers all minimum competency requirements for each Montana-licensed ND to prescribe safely. In addition, every ND is required to maintain ongoing pharmacology CE yearly. See RESPONSES 15 and 17.
COMMENT 26: One commenter believed that naturopaths do not receive the education to prescribe medication or anything beyond suggest supplements labeled by the FDA as food supplements.
RESPONSE 26: The board strongly disagrees and notes naturopathic physicians have been practicing in Montana for 30 years with relatively few practice complaints.
COMMENT 27: Several commenters stated that naturopaths lack the education necessary to prescribe medications safely and effectively.
RESPONSE 27: See RESPONSES 15, 17, 18, and 25.
COMMENT 28: One commenter noted that the public may be led to believe that naturopaths have training equivalent to medical doctors and may result in delayed or inappropriate care.
RESPONSE 28: As a distinct health care profession in Montana, per 37-26-102(1), MCA, Montana-licensed NDs have excellent training, offer excellent medical care, and make referrals to specialists when needed. They take these responsibilities seriously and have an excellent safety record in health care. In addition, see RESPONSES 15, 17, and 18.
COMMENT 29: One commenter has seen many patients in clinical trainings who are being treated by naturopaths for thyroid issues and opined that NDs do not understand the pathophysiology or proper treatment for a disease process.
RESPONSE 29: NDs have pathophysiology training and specific training in thyroid. This comment is not limited to NDs, but rather any prescriber may have an issue prescribing for thyroid. There are substandard providers in every profession, and this comment is unfairly targeted at NDs. See RESPONSES 15 and 17 for ND training and education requirements.
RESPONSE 30: One commenter stated that it is not uncommon for a primary care physician or cardiologist to manage complications of hypothyroidism while the naturopathic physician continues to prescribe the offending agent.
RESPONSE 30: The board notes that any specific allegations the commenter may have should be addressed through the disciplinary process. See RESPONSE 29.
COMMENT 31: Multiple commenters opposed the proposal, stating that if naturopathic physicians want to prescribe in the same way as allopathic or osteopathic physicians, they should have to undergo similar training.
RESPONSE 31: Naturopathic physicians undergo pharmacological training, and naturopathic physicians are required to complete CE, specifically in pharmacology, over the course of their career. Allopathic and osteopathic physicians licensed by Montana have no CE requirements for renewal. Please see RESPONSES 15, 17, and 18.
COMMENT 32: One commenter noted that this rule change would allow patients better, more comprehensive care in a timely fashion.
RESPONSE 32: The board appreciates all comments made during the rulemaking process.
COMMENT 33: Multiple commenters noted that this rule change would have no effect on the way they practice.
RESPONSE 33: The board appreciates all comments made during the rulemaking process.
COMMENT 34: One commenter noted that this rule change will result in clarity, which translates into better patient care.
RESPONSE 34: The board agrees and notes that the formulary committee's intent was to increase clarity for prescribers and pharmacists.
COMMENT 35: One commenter noted that naturopathic pharmacology education did not characterize drugs as "natural" or "synthetic."
RESPONSE 35: The board agrees with the commenter. In addition, all pharmacology training for NDs includes the following: Pharmacology education is required for all ND students. Accredited naturopathic medical schools provide instruction on basic principles of pharmacology including clinical indications, pharmacokinetics (to include absorption, distribution, metabolism, and excretion of drugs), pharmacodynamics (including dose-receptor interactions and dose response relationships), mechanisms of action, and the chief side effects and toxicity of prototypical drugs of each of the major contemporary drug classes. Students and doctors are expected to be able to predict the chief therapeutic effects and chief side effects. See RESPONSES 15 and 17. Oregon and Washington removed those requirements in 2005 and 2009, respectively.
COMMENT 36: Several commenters noted these rule changes will clarify and eliminate inefficiencies in Montana's health care system.
RESPONSE 36: The board agrees and notes these rules are part of the formulary committee's work of the past two and a half years and one of its stated goals for NDs, pharmacists, and patients.
COMMENT 37: One commenter opined the board was veering into advocating for the naturopathic profession, rather than protecting patient safety.
RESPONSE 37: The board notes it is conducting this rulemaking to implement a legislative directive in SB 100. The legislature passed the bill by a wide margin, and the board is trusted to draft rules that protect public safety. The Montana people have requested this change. The board members take their duties very seriously and believe this comment is out of line.
COMMENT 38: One commenter suggested the board extend the comment period to allow the Board of Medical Examiners to comment on the package.
RESPONSE 38: The board notes that if any other boards wanted to comment, they could have convened a meeting to discuss the proposal. Individual board members were also free to comment. Further, a medical doctor licensed by the Board of Medical Examiners serves on both the formulary committee and the board and provided input into these rules. The board is not extending the comment period.
COMMENT 39: One commenter requested a joint board meeting between the Board of Medical Examiners and this board to work through the rule changes.
RESPONSE 39: The board notes, as of October 1, 2023, there are four licensing boards with prescriptive authority and does not believe a joint meeting is necessary to work through these proposed rules. The board received input from the formulary committee, which contains both a pharmacist and a medical doctor, in determining to propose these rules. Other licensing boards and licensees were free to submit comments if desired. See RESPONSE 38.
COMMENT 40: One commenter notes that the Board of Pharmacy was consulted as a stakeholder, but that the Board of Medical Examiners was not.
RESPONSE 40: The board consulted with the Board of Pharmacy specifically to address comments both boards received as to confusion over the formulary and specific issues that ND patients were having in getting prescriptions filled. See RESPONSE 38.
COMMENT 41: One commenter believed that these changes are a large expansion of scope, going from the list of medications on the formulary to more than 20,000 FDA-approved prescription drugs.
RESPONSE 41: Drugs are grouped into types, which is covered within the training of naturopathic physicians. Every licensee has an obligation to meet minimum education requirements to practice. The board thinks the number of approved drugs seems inflammatory. Since the previous exemplary formulary was not exhaustive, there was never a measurement of the medications an ND could prescribe. As noted in the RESPONSE 15, all licensees have a professional obligation to practice within the scope of their own education, training, and experience, and meet the minimum levels of competency set by the legislature. The board expects licensees to seek out the training and education necessary to maintain competency.
COMMENT 42: One commenter requested the board investigate the magnitude of expansion and provide an assessment of the risks without requiring an exam.
RESPONSE 42: Please see RESPONSES 15, 17, and 41.
COMMENT 43: One commenter noted that Oregon has a similar scope of practice for naturopaths and indicates the commenter has firsthand experience with unsafe prescriptions for lithium and opioids.
RESPONSE 43: The board notes there have been disciplinary actions for Montana doctors based on prescribing practices for lithium and opioids, which NDs have been able to prescribe for years.
COMMENT 44: One commenter opined that the decline of health care and rising health care costs in the United States began when non-physician groups began to be able to provide health care.
RESPONSE 44: This comment is beyond the scope of the proposed rulemaking.
COMMENT 45: One commenter believed health care costs will continue to rise based on scam treatments that do not work.
RESPONSE 45: This comment is beyond the scope of the proposed rulemaking, and the board strongly objects to the characterization of a licensed profession as a "scam."
COMMENT 46: Several commenters suggested adding an unprofessional conduct rule indicating it is unprofessional conduct for a naturopathic physician to prescribe or dispense outside the scope of practice.
RESPONSE 46: The board notes that 37-1-316, MCA, provides that licensees can be disciplined for conduct not meeting generally accepted standards of practice. No other prescribing professions have this standard, and the board does not see the need to add it at this time.
COMMENT 47: One commenter requested that if the rules proceed, the board may subject itself to lawsuits by having inadequate public protection safeguards.
RESPONSE 47: The board is implementing these rules in response to enacted legislation. The legislature is constitutionally charged with enacting laws, including setting minimum qualifications necessary to obtain a license and engage in practice. The legislature also determines what safeguards are necessary to protect the public.
4. The agency has adopted New Rule I (24.111.614), New Rule II (24.111.615), and New Rule IV (24.111.617) as proposed.
5. The agency has amended ARM 24.111.502, 24.111.503, 24.111.511, 24.111.610, 24.111.611, and 24.111.2301 as proposed.
6. The agency has adopted New Rule III with the following changes, stricken matter interlined, new matter underlined:
NEW RULE III (24.111.616) USE OF FORMULARY DRUGS (1) Endorsed midwives may use the drugs in 37-27-302(2), MCA, according to the following protocol describing the indication for use, dosage, route of administration, and duration of treatment:
AUTH: 37-1-131, 37-27-302, MCA
Certified to the Secretary of State August 15, 2023.
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