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 amendment of ARM 37.86.1103 pertaining to the addition of definitions to the outpatient drugs, fraud, waste, and abuse rules

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NOTICE OF PUBLIC HEARING ON PROPOSED AMENDMENT

TO: All Concerned Persons

1. On November 13, 2014, at 1:30 p.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 amendment of the above-stated rule.

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 November 6, 2014, 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 rule as proposed to be amended provides as follows, new matter underlined, deleted matter interlined:

37.86.1103 OUTPATIENT DRUGS, FRAUD, WASTE, AND ABUSE (1) through (3) remain the same.

(4) "Drug not covered" means that a member is unable to receive a selected medication or class of medication unless a prior authorization is granted.

(4) through (7) remain the same, but are renumbered (5) through (8).

(9) As stated in ARM 37.86.1102, the department may impose prescription limitations and requirements due to inappropriate use of drugs, as determined by professional review. These limitations or requirements may include:

(a) random drug screening;

(b) random pill counts;

(d) restrictions through "Drug Not Covered";

(e) member requirement to have utilized 100 percent of the estimated therapy days prior to granting a prescription authorization; or

(f) member referral to the team care program, as outlined in ARM 37.86.5303.

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

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

4. STATEMENT OF REASONABLE NECESSITY

The department is proposing to amend ARM 37.86.1103 by adding two key components to this rule. This rule was the first step in ensuring several key components of managing prescription drug waste, fraud, and abuse were in administrative rule. In review of the current rule, the department determined that two additional items needed to be added to strengthen the program. In order to rectify this, the department added a definition of "Drug Not Covered" and a description of "Case Management" in new (9).

Case Management works with prescribers to ensure that several steps are being completed when members are having issues managing their controlled substance use. For example, in order for Medicaid to authorize payment for medications of abuse, Case Management will require a treatment contract, random pill counts, random drug screens, and in extreme cases, 100 percent therapy usage prior to refill.

Drug Not Covered is a process in which a member is unable to receive a selected medication or class of medication, unless prior authorization is granted. This is a provider-driven process, meaning that a member's prescribing provider will approve and/or request that the member be restricted in collaboration with Case Management personnel.

These measures are current practice for the Pharmacy Program, but it is beneficial that they be added to the rule to strengthen the process. Placing these programs into rule adds validity and strength to practices that are aiding in identifying and curtailing prescription waste, fraud, and abuse in Medicaid.

Fiscal Impact

No fiscal impact is anticipated by the proposed rule amendments. These proposed amendments are expected to be budget neutral.

The proposed rules are estimated to affect 273 in-state pharmacies, 127 out-of-state pharmacies, 22,469 HMK members, and 124,874 Medicaid members.

5. The department intends to adopt these rule amendments effective January 1, 2015.

6. 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., November 20, 2014.

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

8. 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 6 above or may be made by completing a request form at any rules hearing held by the department.

9. 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.

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

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

/s/ Cary B. Lund /s/ Mary E. Dalton acting for

Cary B. Lund, Attorney Richard H. Opper, Director

Rule Reviewer Public Health and Human Services

Certified to the Secretary of State October 14, 2014.