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| Montana Administrative Register Notice 37-791 | No. 8 04/28/2017 | |
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BEFORE THE DEPARTMENT OF PUBLIC HEALTH AND HUMAN SERVICES OF THE STATE OF MONTANA
TO: All Concerned Persons
1. On May 19, 2017, at 10:00 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 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 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 [email protected].
3. The rule as proposed to be amended provides as follows, new matter underlined, deleted matter interlined:
37.86.1105 OUTPATIENT DRUGS, REIMBURSEMENT (1) and (2) remain the same. (3) The dispensing fee for filling prescriptions is determined for each pharmacy provider annually. (a) The dispensing fee is based on the pharmacy's average cost of filling prescriptions and prescription volume. The average cost of filling a prescription is based on the direct and indirect costs that can be allocated to the cost of the prescription department and that of filling a prescription, as determined from the Montana Dispensing Fee Questionnaire. The prescription volume of a provider is determined using the information provided on the annual Montana Dispensing Fee Questionnaire. (b) and (c) remain the same. (4) In-state pharmacy providers that are new to the Montana Medicaid program are assigned the maximum dispensing fee in ARM 37.85.105(3)(f)(i) until a dispensing fee questionnaire, as provided in (3), can be completed for six months of operation. At that time, a new dispensing fee is assigned which is the lower of the dispensing fee calculated in accordance with (3) for the pharmacy or the maximum allowed dispensing fee provided in (3)(b). (5) through (12) remain the same. (13) Specialty pharmacies, hemophilia treatment centers, or centers of excellence that dispense clotting factors: (a) not purchased through the 340B program will be reimbursed at the lesser of the usual and customary charge, submitted ingredient cost, or wholesale acquisition cost, plus the professional dispensing fee; or (b) when purchased through the 340B program, will be reimbursed the lesser of the usual and customary charge or wholesale acquisition cost, plus the professional dispensing fee.
IMP: 53-2-201, 53-6-101, 53-6-113, MCA
4. STATEMENT OF REASONABLE NECESSITY
The Department of Public Health and Human Services (department) proposes to revise ARM 37.86.1105 to reflect changes required by the federal Centers for Medicare and Medicaid Services (CMS) to the recently approved Pharmacy State Plan. The proposed revisions would change how the department reimburses Medicaid enrolled pharmacies that fail to respond to the dispensing fee questionnaire and also clarify how provider pharmacies are reimbursed for hemophilia drugs.
42 CFR 447 requires Medicaid participating states to analyze and implement appropriate professional dispensing fees. After negotiations with CMS regarding the approved pharmacy state plan, CMS directed the department to modify reimbursement amounts for enrolled pharmacies that fail to respond to the required questionnaire to the department's lowest calculated amount to dispense. Additionally, CMS directed the department to adopt rule language in (13) to clarify the reimbursement methodology for hemophilia drugs.
The proposed rule amendments are necessary to clarify the terms under which pharmacies are appropriately reimbursed, in accordance with federal guidelines, which also provide that Montana Medicaid's outpatient members will continue to have access to care through the dispensing of approved medicines by enrolled pharmacies.
FISCAL IMPACT
The proposed rule amendments will result in an increase in minimal dispensing fees reimbursed to pharmacies that do not fill out the annual dispensing fee questionnaire at an estimated total cost of $19,892.
The proposed rule amendments are estimated to potentially affect 169,451 Medicaid members, and 281 enrolled pharmacies.
5. The department intends the proposed rule amendments to be applied effective July 1, 2017.
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 [email protected], and must be received no later than 5:00 p.m., May 26, 2017.
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.
12. 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 not appropriate for performance-based measurement and therefore are not subject to the performance-based measures requirement of 53-6-196, MCA.
/s/ Brenda K. Elias /s/ Sheila Hogan Brenda K. Elias Sheila Hogan, Director Rule Reviewer Public Health and Human Services
Certified to the Secretary of State April 17, 2017.
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A directory of state agencies is available online at http://www.mt.gov/govt/agencylisting.asp.
For questions about the organization of the ARM or this web site, contact [email protected].
