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.
