subchapter 25K – drugs/pharmacy

 

section .0100 – Reserved for future codification

 

10a ncac 25k .0100       reserved for future codification

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.

 

SECTION .0300 ‑ DRUG USE REVIEW BOARD

 

10A NCAC 25K .0301       ESTABLISHMENT

The Division of Medical Assistance will establish a Drug Use Review Board.  The Drug Use Review Board shall not have rule making authority.  The Division of Medical Assistance shall have the authority to reject recommendations of the Drug Use Review Board.  In the event of such rejections, Division of Medical Assistance shall notify the Drug Use Review Board, in writing, of the reasons for its action and allow the DUR Board an opportunity to reconsider its recommendation or decision.

 

History Note:        Authority G.S. 108A-68; Social Security Act Section 1927(g);

Eff. January 4, 1993;

Transferred from 10A NCAC 22M .0101 Eff. May 1, 2012;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. July 23, 2016.

 

10A NCAC 25K .0302       MEMBERSHIPS

(a)  The DUR Board shall consist of the Division of Medical Assistance Drug Use Review Coordinator and the following appointed positions:

(1)           five licensed and practicing physicians;

(2)           five licensed and practicing pharmacists; and

(3)           at least two additional individuals with knowledge and expertise in one or more of the following:

(A)          prescribing of Medicaid covered outpatient drug;

(B)          dispensing and monitoring of Medicaid covered outpatient drugs;

(C)          drug use review, evaluation, and intervention; or

(D)          medical quality assurance.

(b)  The Division shall appoint members of the DUR Board for up to three one-year terms.  Either party shall have the right to terminate the membership upon five days notice in writing to the other party.  The DUR Coordinator is not an appointed member, is not subject to the term requirement and only serves on the Board while actively employed with DMA as the DUR Coordinator.

(c)  The North Carolina Association of Pharmacists, the North Carolina Medical Society, and the Old North State Medical Society shall be asked by DMA's DUR Coordinator to make nominations for some of the positions on the Board.  The Director may accept or reject nominations received. 

 

History Note:        Authority G.S. 108A‑68; 42 U.S.C. 1396r-8(g)(3)(B);

Eff. January 4, 1993;

Amended Eff. April 1, 2010;

Transferred from 10A NCAC 22M .0102 Eff. May 1, 2012;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. July 23, 2016.

 

10A NCAC 25K .0303       CHAIRMEN

One pharmacist and one physician shall serve as co‑chairmen of the Board.  Beginning in calendar year 1996, each co‑chairman shall be elected by his peers, the term of the chairmen shall be one year, and membership on the Board of at least one previous year shall be required to establish eligibility for serving as the chairman.

 

History Note:        Authority G.S. 108A‑68; Social Security Act Section 1927(g);

Eff. January 4, 1993;

Transferred from 10A NCAC 22M .0103 Eff. May 1, 2012;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. July 23, 2016.

 

10A NCAC 25K .0304       ACTIVITIES

(a)  The activities of the Drug Use Review Board shall include but are not limited to making recommendations for rules to the Division Directors for Medicaid recipients for the following:

(1)           retrospective review of Medicaid claims information for drug therapy problems;

(2)           application of standards for prospective and retrospective Drug Use Review;

(3)           ongoing interventions for prescribers, pharmacists, and recipients targeted toward therapy problems identified in the course of Medicaid retrospective drug use reviews;

(4)           preparation of an annual report to the Division of Medical Assistance on the Drug Use Review process;

(5)           programs to educate pharmacists and prescribers on common drug therapy problems identified in the Medicaid drug use reviews with the aim of improving prescribing or dispensing practices.

(b)  The criteria and standards for the drug therapy review adopted by the Division upon recommendation by the Drug Use Review Board shall be available to pharmacists, prescribers, and the general public.

 

History Note:        Authority G.S. 108A‑68; Social Security Act Section 1927(g);

Eff. January 4, 1993;

Transferred from 10A NCAC 22M .0104 Eff. May 1, 2012;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. July 23, 2016.

 

SECTION .0400 - PROSPECTIVE DRUG REVIEW

 

10A NCAC 25K .0401       PATIENT COUNSELING

Rule 21 NCAC 46 .2504 as adopted by the North Carolina Board of Pharmacy applies to Medicaid and is incorporated by reference including subsequent amendments.  A copy of 21 NCAC 46 .2504 may be downloaded from the N.C. Board of Pharmacy website (http://www.ncbop.org/LawsRules/rules.2500.pdf).  There is no charge.  If a pharmacy fails to comply with the requirements of 21 NCAC 46 .2504, any claim for reimbursement associated with the pharmacy's non-compliance shall be denied, or if already paid, shall be recouped.

 

History Note:        Authority G.S. 108A-68; 42 U.S.C. 1396r-8(g)(2)(A)(ii);

Eff. June 1, 1993;

Amended Eff. March 1, 2010;

Transferred from 10A NCAC 22M .0201 Eff. May 1, 2012.

 

SECTION .0500 - RETROSPECTIVE DRUG USE REVIEW (DUR)

 

10A NCAC 25K .0501       RETROSPECTIVE DRUG USE REVIEW (DUR)

 

History Note:        Authority G.S. 108A‑68; 42 U.S.C. 1396R-8(2)(b)-(C);

Eff. January 4, 1993;

Amended March 1, 2010;

Transferred from 10A NCAC 22M .0301 Eff. May 1, 2012;

Expired Eff. August 1, 2016 pursuant to G.S. 150B-21.3A.

 

10a NCAC 25K .0502       SCREENING AND PATTERN ANALYSIS

At least quarterly, the Medicaid drug claims, in conjunction with other Medicaid claims as needed for clinical purposes, shall be subjected to screening against standards approved by the Drug Use Review Board.  The objective of the screening is to identify patterns of behavior involving prescribers and pharmacists,

or patterns associated with specific drugs or groups of drugs.  Health care patterns of individual Medicaid recipients shall be screened.  In addition, individual incidences of screen failure associated with a specific recipient shall be identified for intervention alerts.

 

History Note:        Authority G.S. 108A‑68; Social Security Act Section 1927(g);

Eff. January 4, 1993;

Transferred from 10A NCAC 22M .0302 Eff. May 1, 2012;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. July 23, 2016.

 

10A NCAC 25K .0503       INTERVENTIONS

The primary objective of the retrospective Drug Use Review is to provide education to pharmacists and prescribers, both individually and collectively, in order to improve prescribing and dispensing practices.  The intervention and educational programs shall be developed by the Drug Use Review Board and shall be updated as more information is available from the retrospective review process.

The Drug Use Review Board may establish referral processes to the Board of Pharmacy, the Board of Medical Examiners, the Board of Dental Examiners, other health care licensing agencies, or the Division of Medical Assistance Program Integrity Section for individual pharmacists or prescriber who continue to demonstrate patterns of prescribing or dispensing which put the Medicaid recipient at risk from drug therapy problems even after repeated warnings through Drug Use Review interventions.

 

History Note:        Authority G.S. 108A‑68; Social Security Act Section 1927(g);

Eff. January 4, 1993;

Transferred from 10A NCAC 22M .0303 Eff. May 1, 2012;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. July 23, 2016.

 

10A NCAC 25K .0504       COMPLIANCE MONITORING

The prescriber's and pharmacist's responses to the interventions undertaken as a result of the retrospective Drug Use Review shall be tracked.  The Drug Use Review Board may establish selection criteria for intensified review and monitoring of individual pharmacists and prescribers.

 

History Note:        Authority G.S. 108A‑68; Social Security Act Section 1927(g);

Eff. January 4, 1993;

Transferred from 10A NCAC 22M .0304 Eff. May 1, 2012;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. July 23, 2016.