section .0100 – Reserved for future codification

Link to law: http://reports.oah.state.nc.us/ncac/title 10a - health and human services/chapter 25 - medical assistance provided/subchapter k/subchapter k rules.html
Published: 2015

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now
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.

 

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.

 

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.

 

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.

 

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)

Retrospective DUR is designed for the DUR Board to review

Medicaid paid claims to identify prescribing patterns of behavior involving

physicians, pharmacists, and recipients such as over treatment, under

treatment, treatment failure, drug-drug interactions, adverse effects,

therapeutic duplication, iatrogenic effects, drug-disease contraindications,

and empiric prescribing.  The Division of Medical Assistance exempts nursing

facility patients from the retrospective portion of the Drug Use Review.  If a

nursing facility is determined to be out of compliance with the drug regimen

review procedures prescribed for such facilities in regulations implementing

section 1919 of the Social Security Act, currently at section 483.60 of title

42, of the Code of Federal Regulations, the retrospective portion of the Drug

Use Review requirements of this Section applies.  Retrospective DUR is designed

for the DUR Board to review Medicaid paid claims to identify prescribing

patterns of behavior involving physicians, pharmacists, and recipients such as

over treatment, under treatment, treatment failure, drug-drug interactions,

adverse effects, therapeutic duplication, iatrogenic effects, drug-disease

contraindications, and empiric prescribing.

 

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.

 

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.

 

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.

 

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.