Administrative Rules of the State of Montana

BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

In the matter of the adoption of New Rules I through III and the amendment of ARM 37.86.4401 pertaining to collaborative practice drug therapy management

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NOTICE OF PUBLIC HEARING ON PROPOSED ADOPTION AND AMENDMENT

TO: All Concerned Persons

1. On May 19, 2017, at 11:00 a.m., the Department of Public Health and Human Services will hold a public hearing in the auditorium of the Department of Public Health and Human Services Building, 111 North Sanders, Helena, Montana, to consider the proposed adoption and amendment of the above-stated rules.

2. The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice. If you require an accommodation, contact the Department of Public Health and Human Services no later than 5:00 p.m. on May 10, 2017, to advise us of the nature of the accommodation that you need. Please contact Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail dphhslegal@mt.gov.

3. The rules as proposed to be adopted provide as follows:

NEW RULE I COLLABORATIVE PRACTICE DRUG THERAPY MANAGEMENT - DEFINITIONS (1) "Clinical pharmacist practitioner" means a pharmacist who meets the requirements outlined in ARM 24.174.526 and is licensed in the State of Montana.

(2) "Collaborative practice drug therapy management" means face-to-face direct member care, provided by a clinical pharmacist practitioner as outlined in ARM 24.174.524. The care provided must be within the scope of practice for clinical pharmacist practitioners.

(3) "Medical practitioner" means a medical practitioner as defined in 37-2-101, MCA.

AUTH: 53-2-201, 53-6-113, MCA

IMP: 53-2-201, 53-6-101, 53-6-113, MCA

NEW RULE II COLLABORATIVE PRACTICE DRUG THERAPY MANAGEMENT - REQUIREMENTS AND ELIGIBILITY (1) These requirements are in addition to those requirements contained in administrative rule and statutory provisions generally applicable to Medicaid providers.

(2) A clinical pharmacist practitioner who provides collaborative practice drug therapy management must:

(a) have a collaborative practice agreement with a medical practitioner, as provided in ARM 24.174.524;

(b) manage a member's drug therapy by providing face-to-face, direct care; and

(3) Members who have at least one chronic condition needing at least one maintenance medication are eligible for collaborative practice drug therapy management.

AUTH: 53-2-201, 53-6-113, MCA

IMP: 53-2-201, 53-6-101 53-6-113, MCA

NEW RULE III COLLABORATIVE PRACTICE DRUG THERAPY MANAGEMENT - REIMBURSEMENT (1) Reimbursement for collaborative practice drug therapy management is reimbursed only to the medical practitioner or facility, at the lower of the following:

(a) the provider's usual and customary charge to the general public for the service; or

(b) the department's current fee schedule in ARM 37.85.105 for the appropriate provider type.

(2) Collaborative practice drug therapy management services performed at a federally qualified health center or rural health clinic will be reimbursed in accordance with ARM 37.86.4401 through 37.86.4420.

AUTH: 53-2-201, 53-6-113, MCA

IMP: 53-2-201, 53-6-101 53-6-113, MCA

4. The rule as proposed to be amended provides as follows, new matter underlined, deleted matter interlined:

37.86.4401 RURAL HEALTH CLINICS AND FEDERALLY QUALIFIED HEALTH CENTERS, DEFINITIONS (1) through (7) remain the same.

(8) "Health professional" means services furnished by a:

(a) physician,;

(b) nurse practitioner (NP),;

(d) certified nurse-midwife (CNM),;

(e) clinical psychologist (CP),;

(f) clinical social worker (CSW),;

(g) licensed professional counselor (LCPC),; ~~and~~

(h) licensed addiction counselor (LAC); and

(i) clinical pharmacist practitioner.

(9) through (17) remain the same.

AUTH: 53-2-201, 53-6-113, MCA

IMP: 53-2-201, 53-6-101, 53-6-111, 53-6-113, MCA

5. STATEMENT OF REASONABLE NECESSITY

The Department of Public Health and Human Services (department) proposes new rules to establish the Collaborative Practice Drug Therapy Management Program in the Montana Medicaid plan. The new program reimburses clinical pharmacist practitioners for providing face-to-face, direct patient care to Medicaid members who have chronic diseases and complex medication regimes. Clinical pharmacist practitioners, as part of the team approach to care, can help identify and resolve drug-therapy problems and ensure that a Medicaid member's medications are appropriate, effective, and safe. The program is intended to improve access to care by increasing the number of patient-care providers within a medical practice and allowing physicians to devote their time to diagnostic assessment and acute care. The new rules outline the definitions, program, and provider requirements for the department's Collaborative Practice Drug Therapy Management Program.

New Rule I

Proposed New Rule I provides a set of definitions for principal terms appearing in the proposed rule. Definitions are an essential feature of understanding the meaning of written text. The department determined that referring to the Board of Pharmacy's requirements for collaborative practice agreements and clinical pharmacist practitioners is appropriate and essential to the implementation of the new rules.

New Rule II

Proposed New Rule II provides the department's requirements for the Collaborative Practice Drug Therapy Management Program. This rule specifies who is able to provide collaborative practice drug therapy management services. It also specifies where the services can be provided and Medicaid members who are eligible for collaborative practice drug therapy management.

New Rule III

Proposed New Rule III outlines the methodology utilized to provide reimbursement for collaborative practice drug therapy management. Reimbursement is provided to the appropriate provider type for where the service is provided.

ARM 37.86.4401

This proposed amendment will add "clinical pharmacist practitioner" to the definition of health professional.

Fiscal Impact

The projected cost of this program is anticipated to be offset by the savings. This rule will impact 13 providers, and 851 Medicaid members.

6. The department intends the proposed rule adoptions and amendments to be applied effective July 1, 2017.

7. Concerned persons may submit their data, views, or arguments either orally or in writing at the hearing. Written data, views, or arguments may also be submitted to: Kenneth Mordan, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; fax (406) 444-9744; or e-mail dphhslegal@mt.gov, and must be received no later than 5:00 p.m., May 26, 2017.

8. The Office of Legal Affairs, Department of Public Health and Human Services, has been designated to preside over and conduct this hearing.

9. The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency. Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices. Notices will be sent by e-mail unless a mailing preference is noted in the request. Such written request may be mailed or delivered to the contact person in 7 above or may be made by completing a request form at any rules hearing held by the department.

10. An electronic copy of this proposal notice is available through the Secretary of State's web site at http://sos.mt.gov/ARM/Register. The Secretary of State strives to make the electronic copy of the notice conform to the official version of the notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the notice and the electronic version of the notice, only the official printed text will be considered. In addition, although the Secretary of State works to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems.

11. The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

12. With regard to the requirements of 2-4-111, MCA, the department has determined that the adoption and amendment of the above-referenced rules will not significantly and directly impact small businesses.

13. Section 53-6-196, MCA, requires that the department, when adopting by rule proposed changes in the delivery of services funded with Medicaid monies, make a determination of whether the principal reasons and rationale for the rule can be assessed by performance-based measures and, if the requirement is applicable, the method of such measurement. The statute provides that the requirement is not applicable if the rule is for the implementation of rate increases or of federal law.

The department has determined that the proposed program changes presented in this notice are appropriate for performance-based measurement and therefore are subject to the performance-based measures requirement of 53-6-196, MCA. The proposed addition of Collaborative Practice Drug Therapy Management can be assessed by performance-based measures. The effectiveness of the Collaborative Practice Drug Therapy Management will be measured by reviewing the medication adherence of members who utilize Collaborative Practice Drug Therapy Management, through the Proportion of Days Covered methodology. This will be completed by:

1. calculating the Proportion of Days Covered for the first nine months following adoption of the proposed change. The Proportion of Days Covered would be calculated based on medication to treat the following conditions:

a. diabetes;

b. COPD;

c. asthma;

d. hypertension; and

e. hyperlipidemia.

2. calculating the Proportion of Days Covered for the nine months prior to the adoption of the proposed change. The Proportion of Days Covered would be calculated based on medication to treat the following conditions:

a. diabetes;

b. COPD;

c. asthma;

d. hypertension; and

e. hyperlipidemia.

3. comparing the calculated adherence ratios of before Collaborative Practice Drug Therapy Management and after for the conditions listed below:

a. diabetes;

b. COPD;

c. asthma;

d. hypertension; and

e. hyperlipidemia.

/s/ Brenda K. Elias /s/ Sheila Hogan

Brenda K. Elias, Attorney Sheila Hogan, Director

Rule Reviewer Public Health and Human Services

Certified to the Secretary of State April 17, 2017.