section .0200 – pharmacy services
10A NCAC 25K .0201 PHARMACY SERVICES
(a) Reimbursement is provided for legend drugs, insulin, and over-the-counter (OTC) drugs documented in General Policy A2 on the Division of Medical Assistance (DMA) website. The list of covered OTC drugs is on Attachment A of General Policy No. A-2. The following is a list of requirements for coverage of drugs.
(1) The prescribed drug must have a Federal Drug Administration (FDA) approved indication.
(2) The prescribed drug must bear the federal legend statement.
(3) The legend drug must be manufactured by a company that has signed a National Medicaid Drug Rebate Agreement with the Centers for Medicare and Medicaid Services (CMS).
(4) The OTC drugs selected for coverage by DMA must be manufactured by a company that has signed a National Medicaid Drug Rebate Agreement with CMS.
(5) Compounded drugs are covered when a mixture of two or more ingredients is physically inseparable, at least one of the components of the compounded drug is a legend drug, the quantity of legend drug is sufficient to have a therapeutic effect, and the legend drug is manufactured by a company that has signed a national Medicaid Drug Rebate Agreement with the Centers for Medicare and Medicaid Services (CMS).
(6) Reimbursement is not provided for prescribed drugs documented on the CMS Drug Efficacy Study Implementation (DESI) list. These drugs are also known as less than effective (LTE) drugs.
(b) A prescription for a drug written under its brand or trade name shall be filled with a generic version of the drug when one is commercially available unless the prescriber has indicated that the brand name drug is medically necessary for the recipient. The prescriber shall indicate this by writing "medically necessary" on the face of the prescription order for the drug. The selection of a drug product shall not be more expensive than the brand or trade name originally written by the prescriber. The pharmacist shall fill the prescription with the least expensive generic in the pharmacy.
(c) All prescriptions must comply with state and federal laws and regulations for legal prescriptions.
(d) A credit must be issued by the pharmacy provider for returned medications returned to stock.
(e) The maximum days supply for all drugs is 34-day supply unless the medication meets the criteria for a 90-day supply indicated in Clinical Coverage Policy 9 on the DMA website.
(f) DMA shall impose a prior authorization program for covered outpatient drugs that comply with requirements of 42 U.S.C. 1396r–8 (d)(1)(A) and in accordance with Session Law 2009-451, and any subsequent amendments.
(g) DMA shall impose quantity limitations for drugs that are meant to be used episodically and dispensed in quantities that support less than daily use. Those drugs designated as episodic drugs are defined in Clinical Coverage Policy 9 on the DMA website.
(h) Recipients who receive more than 11 unduplicated prescriptions per month shall be evaluated as part of a Focused Risk Management (FORM) Program. The FORM Program is an interdisciplinary, team-based approach including the pharmacy and the recipient's personal care physician for coordination of recipient care. The following are requirements for the FORM Program:
(1) The pharmacist shall coordinate, integrate, and communicate a comprehensive review plan with the patient's primary care provider.
(2) The comprehensive review plan shall identify, resolve, and recommend cost-effective, safe, and efficacious drug alternatives; and shall include a list of all medications dispensed at the pharmacy during the review period and a list of recommendations to improve the recipients drug regimen.
(3) The pharmacy shall communicate the comprehensive review plan to the recipient's PDP for review and coordination of care. The pharmacist shall obtain a written response from the PDP that accepts or modifies the comprehensive review plan. If the PDP fails to provide a response within one month from the date of the communication, the pharmacy shall document such failure on the comprehensive review plan.
(4) The first review must be completed within two months of the recipient's identification for the program. Reviews thereafter shall be performed quarterly.
(5) DHHS, Division of Medical Assistance shall make a professional services fee to the pharmacy provider on a quarterly basis, based on the completion of the comprehensive review plan under FORM Program for each identified recipient. The professional services fee is based on average time for the pharmacist to complete the review at an estimated average pharmacist hourly wage.
(6) A failure to perform a required comprehensive review plan or failure to have documentation of the review on file at the time of audit, shall result in the recoupment of professional service fee and payment for all claims that exceed the limit of 11 unduplicated prescriptions per month during those periods of time when a completed comprehensive review plan was not in place.
(i) All recipients receiving more than 11 unduplicated prescriptions per month must participate in the FORM program. The following rules apply to the recipient:
(1) The recipient shall choose a single pharmacy of his/her choice.
(2) The recipient may elect to change his/her pharmacy provider by request made to DMA or DMA's fiscal agent from the current pharmacist or from the recipient's primary care provider.
(3) Emergency fills for recipients are limited to a four-day supply.
(4) The following recipients are exempt from the FORM program:
(A) recipients under the age of 21;
(B) recipients residing in a nursing facility or an intermediate care facility for individuals with mental retardation; and
(C) recipients residing in an assisted living facility or group home.
(j) No pharmacist is required to accept a new recipient. Pharmacists may accept new recipients of their choice.
(k) Copayments shall be charged in accordance with 10A NCAC 22D .0101.
History Note: Authority G.S. 90-85.26; 108A-25(b); 108A-54; 42 C.F.R. 440.90; 42 CFR 447.331; S.L. 1985, c. 479, s. 86; 42 U.S.C. 1396r-8(d)(1)(A); S.L 2009-451;
Eff. September 30, 1977;
Readopted Eff. October 31, 1977;
Amended Eff. January 1, 1984;
Recodified from 10 NCAC 26B .0116 Eff. October 1, 1993;
Recodified from 10 NCAC 26B .0117 Eff. January 1, 1998;
Amended Eff. May 1, 2010;
Transferred from 10A NCAC 22O .0118 Eff. May 1, 2012.