NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 i
To all beneficiaries enrolled in a Prepaid Health Plan (PHP): for questions about benefits and
services available on or after implementation, please contact your PHP.
Table of Contents
1.0 Description of the Procedure, Product, or Service ........................................................................... 1
1.1 Definitions .......................................................................................................................... 1
Legend Drugs ...................................................................................................................... 1
Drug Use Review (DUR) .................................................................................................... 1
Narrow Therapeutic Index (NTI) ........................................................................................ 1
Long Acting Injectable (LAI) ............................................................................................. 1
2.0 Eligibility Requirements .................................................................................................................. 1
2.1 Provisions............................................................................................................................ 1
2.1.1 General ................................................................................................................... 1
2.1.2 Specific .................................................................................................................. 2
2.2 Special Provisions ............................................................................................................... 2
2.2.1 EPSDT Special Provision: Exception to Policy Limitations for a Medicaid
Beneficiary under 21 Years of Age ....................................................................... 2
3.0 When the Procedure, Product, or Service Is Covered ...................................................................... 3
3.1 General Criteria Covered .................................................................................................... 3
3.2 Specific Criteria Covered .................................................................................................... 3
3.2.1 Specific criteria covered by Medicaid ................................................................... 3
3.2.2 Medicaid Additional Criteria Covered ................................................................... 4
3.2.3 Exceptions to FDA and NC Medicaid Drug criteria approval. .............................. 4
3.3 Coverage of Compounded Drugs ........................................................................................ 5
3.4 Medicaid Drug Rebate Program ......................................................................................... 5
3.4.1 Federal Drug Medicaid Rebate Program ............................................................... 5
3.4.2 N.C. Medicaid Supplemental Drug Rebate Program ............................................. 5
3.5 Optional Drug Donation ..................................................................................................... 6
3.5.1 Long Acting Injectable Antipsychotic (LAIs) ....................................................... 6
4.0 When the Procedure, Product, or Service Is Not Covered ............................................................... 7
4.1 General Criteria Not Covered ............................................................................................. 7
4.2 Specific Criteria Not Covered ............................................................................................. 7
4.2.1 Specific Criteria Not Covered by Medicaid ........................................................... 7
4.2.2 Medicaid Additional Criteria Not Covered ............................................................ 8
5.0 Requirements for and Limitations on Coverage .............................................................................. 8
5.1 Prior Authorization ............................................................................................................. 8
5.1.1 Prior Authorization Process for Pharmacists Serving Long Term Care Facilities . 9
5.2 N.C. Medicaid Preferred Drug List ..................................................................................... 9
5.3 Management of Polypharmacy and Low Adherence .......................................................... 9
5.4 Dispensing and Maximum Supply .................................................................................... 10
5.4.1 Birth Control and Hormone ReplacementTherapies ............................................ 10
5.4.2 Non-Controlled Maintenance Medications .......................................................... 10
5.4.3 Quantity and Episodic Drugs ............................................................................... 10
5.5 Co-payments ..................................................................................................................... 10
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 ii
5.5.1
Medicaid Co-payment Requirements .................................................................. 10
5.5.2 Co-payment Exemptions ...................................................................................... 11
5.6 Returned Medication ......................................................................................................... 11
5.7 Automatic Refills and Shipments ..................................................................................... 11
5.8 Generic Substitution ......................................................................................................... 12
5.8.1 Generic Substitution for Brand Medically Necessary Medications ..................... 13
5.8.2 Generic Substitution for Narrow Therapeutic Index Drugs ................................. 13
5.9 Maximum Allowable Cost (MAC) ................................................................................... 13
5.9.1 NADAC generic rate and MAC Override ........................................................... 14
5.9.2 Provider State MAC Inquiries ............................................................................. 15
5.9.3 Unacceptable Practices for Drugs with MAC Prices ........................................... 15
5.9.4 Prenatal Vitamins ................................................................................................. 16
5.10 Hemophilia Specialty Pharmacy Program ........................................................................ 16
5.11 Narrow Therapeutic Index Drugs ..................................................................................... 16
5.12 Billing for Partial Fills ...................................................................................................... 16
5.13 Incorrect Units for Unbreakable Packages ....................................................................... 17
5.14 Beneficiary Management Lock-In Program ..................................................................... 17
5.14.1 Inclusion in the Beneficiary Management Lock-In Program............................... 18
5.14.2 Exclusions from the Beneficiary Management Lock-In Program ....................... 18
5.14.3 Emergency Supplies for the Beneficiary Management Lock-In Program ........... 18
6.0 Provider(s) Eligible to Bill for the Procedure, Product, or Service ............................................... 19
6.1 Provider Qualifications and Occupational Licensing Entity Regulations ......................... 19
6.2 Filling Prescriptions .......................................................................................................... 19
6.3 Changes in Pharmacy Status ............................................................................................. 19
7.0 Additional Requirements ............................................................................................................... 20
7.1 Compliance ....................................................................................................................... 20
7.2 Record Retention .............................................................................................................. 20
7.3 Pharmacy Audits ............................................................................................................... 20
7.4 Medicaid Recoupments ..................................................................................................... 21
7.5 Emergency Preparedness Protocol .................................................................................... 21
8.0 Policy Implementation/Revision Information ................................................................................ 22
Attachment A: Claims-Related Information ............................................................................................... 35
A. General Information .......................................................................................................... 35
B. Directions for Drug Reimbursement ................................................................................. 35
B.1 Vaccines ............................................................................................................................ 35
B.2 Dispensing Fee .................................................................................................................. 35
B.3 Cost of the Drug ................................................................................................................ 35
B.4 State Maximum Allowable Cost (SMAC) List ................................................................. 36
B.5 Hemophilia Specialty Pharmacy Program ........................................................................ 37
B.6 National Drug Code (NDC) .............................................................................................. 37
B.7 Drug Units......................................................................................................................... 37
C. Billing Pharmacy Claims through Online, Real-Time Point of Sale ................................ 37
C.1 Obtaining Point-of-Sale Software from a Vendor ............................................................ 38
C.2 Online Point-of-Sale Processing Downtime ..................................................................... 38
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
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C.3
Compound Prescription Claims on Point-of-Sale ............................................................. 38
C.4 Point-of-Sale Claims over $9,999 ..................................................................................... 38
C.5 Time Limit for Point-of-Sale Claims ................................................................................ 38
C.6 Claims Processing for Selected DME Products ................................................................ 38
D. Provider Retroactive Pharmacy Claims Billing ................................................................ 39
E. Billing Medicare before Medicaid .................................................................................... 39
F. Billing Remainder of a Third-Party Prescription to Medicaid .......................................... 40
G. Billing for Nursing Home Prescriptions and IV Therapy ................................................. 41
H. Billing for Drugs Covered under Hospice ........................................................................ 41
I. Compounded Drugs .......................................................................................................... 42
I.1 Billing for Compounded Drugs ........................................................................................ 42
I.2 Reimbursement for Compound Drugs .............................................................................. 42
I.3 Summary of Compound Drug Reimbursement ................................................................ 42
J. Point-of-Sale Reversals ..................................................................................................... 42
K. High Dosage Edit .............................................................................................................. 43
L. Time Limit Overrides ....................................................................................................... 43
M. Pharmacy Remittance Advice ........................................................................................... 43
N. Resubmission of Rejected or Denied Claims .................................................................... 44
N.1 Explanation of Benefit Codes ........................................................................................... 44
N.2 Resubmitting a Claim ....................................................................................................... 44
N.3 Name and Number Mismatch ........................................................................................... 44
N.4 Eligibility Follow-Up ........................................................................................................ 44
Attachment B: Table of Exemptions to Co-payment and Specific Edit Override Information .................. 45
Attachment C: Requesting Prior Authorization for Prescription Drugs ..................................................... 46
Attachment D: Narrow Therapeutic Index Drugs ....................................................................................... 47
Attachment E: Drug Use Review Program ................................................................................................. 48
A. NC Medicaid ..................................................................................................................... 48
B. DUR Board ....................................................................................................................... 48
C. Prospective DUR .............................................................................................................. 48
C.1 Purpose.............................................................................................................................. 48
C.2 Procedure for Responding to DUR Alerts ........................................................................ 49
C.3 Counseling ........................................................................................................................ 50
C.4 Information on Medicaid Beneficiaries ............................................................................ 51
D. Retrospective DUR ........................................................................................................... 51
D.1 Overview ........................................................................................................................... 51
D.2 Profiling Systems Used by the Retrospective Drug Use Review Program ....................... 52
E. Statutory DUR Requirements and Impact on Pharmacies ................................................ 53
E.1 Beneficiary Profiles .......................................................................................................... 53
E.2 Screening .......................................................................................................................... 53
E.3 Beneficiary Counseling ..................................................................................................... 54
F. Requirement for Accurate Data on Pharmacy Claims ...................................................... 56
F.1 Day Supply ....................................................................................................................... 56
F.2 Prescriber Identification Number ...................................................................................... 56
F.3 Quantity Dispensed ........................................................................................................... 56
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
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G.
Point-of-Sale/Online Prospective Drug Use Review ........................................................ 56
G.1 Introduction ....................................................................................................................... 56
G.2 OBRA ’90 and Outpatient Drug Use Review ................................................................... 56
G.3 Objectives ......................................................................................................................... 57
G.4 Point-of-Sale System Operations ...................................................................................... 57
G.5 Prospective Drug Use Review System ............................................................................. 57
G.6 National Council for Prescription Drug Programs (NCPDP) Standards .......................... 58
G.7 DUR Alert Message Examples ......................................................................................... 60
G.8 DUR Alert Priority ............................................................................................................ 61
G.9 DUR Alert Definitions ...................................................................................................... 61
G.10 Online DUR Criteria ......................................................................................................... 62
G.11 Procedure for Responding to DUR Alerts ........................................................................ 64
H. Point-of-Sale/Pro-DUR Transaction Flows ...................................................................... 65
I. Drug–Drug Interaction Example ....................................................................................... 71
J. Over Utilization/Early Refill Example ............................................................................. 71
K. Under Utilization/Late Refill Example ............................................................................. 71
L. Low Dose/High Dose Example ........................................................................................ 72
M. Therapeutic Duplication Example .................................................................................... 73
Attachment F: Summary of Billing Requirements ..................................................................................... 74
Attachment G: Defining the Drug Unit ....................................................................................................... 77
Attachment H: Summary of Point-of-Sale Codes and Other Information for Current Claim Format ........ 78
Attachment I: Pharmacy Remittance Advice (RA) ..................................................................................... 80
Attachment J: ICD-10-CM Codes to Indicate Pregnancy ........................................................................... 81
Attachment K: Pharmacy Prior Approval Criteria ...................................................................................... 82
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
CPT codes, descriptors, and other data only are copyright 2023 American Medical Association.
All rights reserved. Applicable FARS/DFARS apply.
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24F27
Related Clinical Coverage Policies
Refer to https://medicaid.ncdhhs.gov/for the related coverage policies listed below:
9A, Over the Counter Products
9B, Hemophilia Specialty Pharmacy Program
1.0 Description of the Procedure, Product, or Service
The following policy applies to NC Medicaid (Medicaid) covered legend drugs and covered over
the counter (OTC) products dispensed by outpatient pharmacy providers.
1.1 Definitions
Legend Drugs
Are drugs defined by the Federal Food, Drug and Cosmetic Act, as amended, and under
which definition its label is required to bear the statement "Caution: Federal law prohibits
dispensing without prescription.
Drug Use Review (DUR)
For Drug Use Review (DUR) definition refer to: Attachment E: G.9
Narrow Therapeutic Index (NTI)
Are pharmaceuticals having a narrowly defined range between risk and benefit.
Long Acting Injectable (LAI)
Are injectable formulations intended for prolonged or sustained drug release over a long
period of time ranging from a few days to months.
2.0 Eligibility Requirements
2.1 Provisions
2.1.1 General
(The term “General” found throughout this policy applies to all Medicaid
policies)
a. An eligible beneficiary shall be enrolled in the NC Medicaid Program
(Medicaid is NC Medicaid program, unless context clearly indicates
otherwise).
b. Provider(s) shall verify each Medicaid beneficiary’s eligibility each time a
service is rendered.
c. The Medicaid beneficiary may have service restrictions due to their
eligibility category that would make them ineligible for this service.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
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2.1.2 Specific
(The term “Specific” found throughout this policy only applies to this policy)
a. Medicaid
None Apply.
2.2 Special Provisions
2.2.1 EPSDT Special Provision: Exception to Policy Limitations for a
Medicaid Beneficiary under 21 Years of Age
a. 42 U.S.C. § 1396d(r) [1905(r) of the Social Security Act]
Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) is a
federal Medicaid requirement that requires the state Medicaid agency to
cover services, products, or procedures for Medicaid beneficiary under 21
years of age if the service is medically necessary health care to correct or
ameliorate a defect, physical or mental illness, or a condition [health
problem] identified through a screening examination (includes any
evaluation by a physician or other licensed practitioner).
This means EPSDT covers most of the medical or remedial care a child
needs to improve or maintain his or her health in the best condition possible,
compensate for a health problem, prevent it from worsening, or prevent the
development of additional health problems.
Medically necessary services will be provided in the most economic mode,
as long as the treatment made available is similarly efficacious to the service
requested by the beneficiary’s physician, therapist, or other licensed
practitioner; the determination process does not delay the delivery of the
needed service; and the determination does not limit the beneficiary’s right to
a free choice of providers.
EPSDT does not require the state Medicaid agency to provide any service,
product or procedure that is:
1. unsafe, ineffective, or experimental or investigational.
2. not medical in nature or not generally recognized as an accepted method
of medical practice or treatment.
Service limitations on scope, amount, duration, frequency, location of
service, and other specific criteria described in clinical coverage policies may
be exceeded or may not apply as long as the provider’s documentation shows
that the requested service is medically necessary “to correct or ameliorate a
defect, physical or mental illness, or a condition” [health problem]; that is,
provider documentation shows how the service, product, or procedure meets
all EPSDT criteria, including to correct or improve or maintain the
beneficiary’s health in the best condition possible, compensate for a health
problem, prevent it from worsening, or prevent the development of additional
health problems.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
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b. EPSDT and Prior Approval Requirements
1. If the service, product, or procedure requires prior approval, the fact that
the beneficiary is under 21 years of age does NOT eliminate the
requirement for prior approval.
2. IMPORTANT ADDITIONAL INFORMATION about EPSDT and
prior approval is found in the NC Tracks Provider Claims and Billing
Assistance Guide, and on the EPSDT provider page. The Web addresses
are specified below.
NC Tracks Provider Claims and Billing Assistance Guide:
https://www.nctracks.nc.gov/content/public/providers/provider-
manuals.html
EPSDT provider page: https://medicaid.ncdhhs.gov/
3.0 When the Procedure, Product, or Service Is Covered
Note: Refer to Subsection 2.2.1 regarding EPSDT Exception to Policy Limitations for a
Medicaid Beneficiary under 21 Years of Age.
3.1 General Criteria Covered
Medicaid shall cover the procedure, product, or service related to this policy when
medically necessary, and:
1. the procedure, product, or service is individualized, specific, and consistent with
symptoms or confirmed diagnosis of the illness or injury under treatment, and not in
excess of the beneficiary’s needs;
2. the procedure, product, or service can be safely furnished, and no equally effective
and more conservative or less costly treatment is available statewide; and
3. the procedure, product, or service is furnished in a manner not primarily intended for
the convenience of the beneficiary, the beneficiary’s caretaker, or the provider.
3.2 Specific Criteria Covered
3.2.1 Specific criteria covered by Medicaid
The Medicaid Outpatient Pharmacy Programs shall cover prescribed drugs when
they meet all the following guidelines and specific criteria listed in this policy:
a. The prescribed drug must have Federal Drug Administration (FDA)
approved indication or is used for a medically accepted indication for which
it is prescribed unless approval is given by DHB;
b. The prescribed drug must bear the federal legend statement;
c. A 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);
d. Selected OTC products including insulin are covered when they meet the
criteria listed in clinical coverage policy 9A, Over the Counter Products, at
https://medicaid.ncdhhs.gov/;
e. The prescription must be written for whom the claim is billed;
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
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f. The vaccine is a covered service when the pharmacy is compliant with all
North Carolina Medicaid Billing Procedures, Federal laws, and State laws
with regard to vaccines;
g. Prenatal vitamins and fluoride; and
h. Legend Calcitriol (vitamin D) when used for a predialysis beneficiary, a
dialysis beneficiary, and a hypoparathyroidism beneficiary.
3.2.2 Medicaid Additional Criteria Covered
None Apply
3.2.3 Exceptions to FDA and NC Medicaid Drug criteria approval.
Medicaid may restrict coverage of an outpatient drug as found in Section
1927(d)(1)(B)(i) of the Social Security Act if the prescribed drug is not for a
medically accepted indication. Medically accepted indication means any use for a
covered outpatient drug which is approved under the Federal Food, Drug, and
Cosmetic Act, or the use of which is supported by one or more citations included
or approved for inclusion in any of the compendia described in subsection
(g)(1)(B)(i)".The compendia include:
a. American Hospital Formulary Service Drug Information
b. United States Pharmacopeia-Drug Information(or its successor publications);
c. DRUGDEX Information System; or
d. As per 1927(d)(1)(B)(ii), peer-reviewed medical literature.
When a provider determines the indication or dosing for a particular drug is
medically necessary for a beneficiary, but those parameters fall outside of the
FDA approved guidelines and evidence-based standards for that drug, or NC
Medicaid Drug Criteria for that drug, the provider may make a request for the
medically necessary indication or dosing for a particular drug.
To request approval, a provider shall submit, along with the usual drug request
forms the required additional information:
a. Health record information to show medical necessity for the requested drug;
b. An explanation of what other drugs have been tried or why they cannot be
tried;
c. An explanation from the prescribing medical professional of why the FDA
approved guidelines and evidence-based standards for that drug or NC
Medicaid Drug Criteria is insufficient for this beneficiary and
d. Compendia/peer-reviewed medical literature supporting the use of the
requested drug (as per 42U.S.C. 1396r 8(g)(1)(B)).
The address to send this information is:
Pharmacy Manager for Clinical Policy and Programs
Division of Health Benefits
NC Medicaid
2501 Mail Service Center
Raleigh, NC 27699-2501
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 5
3.3 Coverage of Compounded Drugs
Medicaid shall cover compounded products when:
1. a mixture of two or more ingredients is physically inseparable;
2. at least one of the components of the compounded drug is a legend drug;
3. it is expected that the quantity of legend drug is sufficient to have a therapeutic
effect; and
4. the legend drug is manufactured by a company that has signed a national Medicaid
Drug Rebate Agreement with Centers for Medicaid and Medicare Services (CMS).
A compounded prescription contains a quantity of a legend drug sufficient to have a
therapeutic effect and cannot be two different drugs (capsules or tablets) separable but
dispensed in the same bottle.
Refer to Attachment A, Section J, Compounded Drugs, for additional information on
billing and reimbursement.
3.4 Medicaid Drug Rebate Program
3.4.1 Federal Drug Medicaid Rebate Program
https://www.medicaid.gov/Federal-Policy-Guidance/downloads/smd091802.pdf
The Medicaid Outpatient Pharmacy Programs shall cover drugs from
manufacturers who have signed a national Medicaid Drug Rebate Agreement
with CMS. Drug companies sign the agreement for specific drug manufacturer
codes. Drug coverage is determined by the manufacturer code and not by the
manufacturer name. The manufacturer code is indicated by the first five digits of
the 11-digit National Drug Code (NDC) number.
Rebates are determined by North Carolina’s Medicaid utilization data.
Pharmacies are required to use the NDC number of the drug actually dispensed.
If accurate NDCs are not used, there is the potential for denial of claims,
sanctions, and termination of provider agreements.
The Medicaid program shall supply pharmacy providers with a list of any
additions or deletions to the list of covered Medicaid Rebate Manufacturers
through newsletters posted on NC Medicaid’s website at
https://medicaid.ncdhhs.gov/.
3.4.2 N.C. Medicaid Supplemental Drug Rebate Program
The Medicaid Outpatient Pharmacy Program also participates in a supplemental
drug rebate program for the Medicaid program. The State negotiates
supplemental rebates in addition to federal rebates for both programs. Payment of
supplemental rebates results in a drug being added to the preferred drug list.
Refer to Subsection 5.2, N.C. Medicaid Preferred Drug List.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 6
3.5 Optional Drug Donation
3.5.1 Long Acting Injectable Antipsychotic (LAIs)
Medicaid beneficiaries may donate prescribed and abandoned Long Acting
Injectable Antipsychotics (LAIs) defined below to a registered Drug Repository
Program, as defined under and in accordance with N.C.G.S §90-85.44 at
https://www.ncleg.net/EnactedLegislation/Statutes/PDF/BySection/Chapter_90/
GS_90-85.44.pdf
Abandoned LAIs may only be donated to a registered Drug Repository Program
when all of the following requirements are met:
a. LAI has been ordered by the provider and intended for use by a Medicaid
beneficiary;
b. Pharmacy has released the LAI to the provider for administration and
Medicaid has paid the pharmacy for the LAI;
c. Medicaid beneficiary has not appeared for their appointment to receive the
LAI or has otherwise declined, in writing, to receive the injection;
d. Medicaid beneficiary has not appeared for their appointment, and the
Provider has made at least two phone calls and a letter of notification to
contact the Medicaid beneficiary about their failure to appear for their
appointment as described below;
e. Provider has either been unable to make contact with the Medicaid
beneficiary or the Medicaid beneficiary’s intent to abandon the LAI is
documented as required in this policy; and
f. Dispensing pharmacy is unable to take the medication back.
An “abandoned” LAI is defined as a LAI, prescribed for a specific beneficiary,
dispensed to the beneficiary’s provider for administration, and the beneficiary
either fails to appear for the administration of the LAI and meet the requirements
described below, or the provider obtains written documentation of the
beneficiary’s refusal to receive the LAI.
For a Medicaid beneficiary who has not appeared for their appointment, the LAI
is considered “abandoned” 30 days after the missed date of administration of the
LAI dose and after the provider has made at least 2 calls to the beneficiary and
has sent a letter of notification to the beneficiary regarding the missed LAI dose.
The LAI is considered abandoned if there is no response from the beneficiary
after the provider has made three ( 3 ) outreach attempts to the beneficiary
described above or the provider documents the beneficiary’s refusal to receive
the LAI.
To allow for donation of an abandoned LAI by a NC Medicaid beneficiary, the
provider shall obtain and keep in the beneficiary’s record a signed consent of the
Medicaid beneficiary donor’s willingness to donate the abandoned LAI. The
provider may satisfy this requirement by obtaining at the initial beneficiary visit
where the LAI is prescribed a signed consent from the Medicaid beneficiary
stating that the beneficiary agrees to have the provider donate any abandoned
doses of the LAI on the beneficiary’s behalf to a registered Drug Repository
Program according to N.C.G.S. §90-85.44. The consent must clearly explain to
the beneficiary when the LAI is considered “abandoned” as defined above in this
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 7
policy so that the beneficiary is fully aware of the point at which their medication
is considered abandoned.
Once an LAI is “abandoned,” the LAI must be donated to a registered Drug
Repository Program in the original unopened container or box as defined under
N.C.G.S. §90-85.44(b). The provider shall not re-use or administer the LAI to
another patient outside of a registered Drug Repository Program. In addition to
the above, a provider must:
a. Adhere to all NC Board of Pharmacy procedures and policies with respect to
abandoned LAI donation;
b. NOT bill Medicaid for administration of the LAI, if the medication is
abandoned and donated. A provider shall only bill administration fees where
the Medicaid beneficiary receives the LAI;
c. For any LAI abandoned by a Medicaid beneficiary, the prescriber shall
clearly document ongoing psychoeducation efforts and medication
management decision-making with the beneficiary along with the consent or
withdrawal of consent for ongoing treatment with LAIs, to reduce the
likelihood of future LAI abandonment; and
d. Cooperate with any investigations for fraud, waste, or abuse and monitoring,
as a provider is subject to Medicaid Provider Participation Agreement terms.
4.0 When the Procedure, Product, or Service Is Not Covered
Note: Refer to Subsection 2.2.1 regarding EPSDT Exception to Policy Limitations for a
Medicaid Beneficiary under 21 Years of Age.
4.1 General Criteria Not Covered
Medicaid shall not cover the procedure, product, or service related to this policy when
the:
a. the beneficiary does not meet the eligibility requirements listed in Section 2.0;
b. the beneficiary does not meet the criteria listed in Section 3.0;
c. the procedure, product, or service duplicates another provider’s procedure, product,
or service; or
d. the procedure, product, or service is experimental, investigational, or part of a clinical
trial.
4.2 Specific Criteria Not Covered
4.2.1 Specific Criteria Not Covered by Medicaid
Medicaid shall not cover the following:
a. OTC products. Refer to Subsection 3.2.1(b) Federal legend drugs or their
generic equivalents that are on the Drug Efficacy Study Implementation
(DESI) list established by the FDA;
b. Any drug manufactured by a company that has not signed a rebate
agreement. Exception shall be made for CroFab, and selected vaccines and
radiopharmaceuticals;
c. Fertility drugs;
d. Drugs used for cosmetic indications;
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 8
e. Medical supplies and devices. Refer to Attachment A, Subsection C.6,
Claims Processing for Selected Durable Medical Equipment (DME)
Products;
f. Diaphragms, which are a family planning service;
g. Intravenous (IV) fluids (Dextrose 500 ml or greater) and irrigation fluids;
except for living arrangement codes 10 (Private Living Arrangement (not 1/3
reduction), 11 (Private Living Arrangement (with 1/3 reduction) (Medicaid
Only), 13 (Living with Supplemental Security Income (SSI) Beneficiary), 52
(Domiciliary care, Six or More Beds (Special Assistance for the Aged
(SAA), Special Assistance for the Disabled (SAD), 53 (Foster Care
(Medicaid for Families (MAF), Medicaid for Infants and Children (MIC),
State Foster Home Fund (HSF), Medicaid with IV-E Adoption Subsidy and
Foster Care (IAS)) or 80 (Adoptive Home (MAF, MIC, MRF (Refugee
Medical Assistance), HSF, IAS));
h. Erectile dysfunction drugs;
i. Weight loss and weight gain drugs;
j. Drug samples;
k. Drugs obtained from any beneficiary assistance program;
l. Drugs used for the symptomatic relief of cough and colds that contain
expectorants or cough suppressants;
m. Legend vitamins and mineral products. Refer to Subsection 3.2.1(b);
n. All DESI drugs and combinations equivalent to a DESI drug in compounded
prescriptions. Drugs described by the FDA as DESI are products that the
FDA has found to be less than effective or not proven to be as effective as
indicated. Drug products that are identical, related or similar to DESI drugs
are considered DESI. Updates and corrections are published in the Pharmacy
Newsletters on Medicaid’s website, https://medicaid.ncdhhs.gov/
; or
o. A compounded prescription which is equivalent to an OTC product.
4.2.2 Medicaid Additional Criteria Not Covered
None Apply.
5.0 Requirements for and Limitations on Coverage
Note: Refer to Subsection 2.2.1 regarding EPSDT Exception to Policy Limitations for
Medicaid Beneficiaries under 21 Years of Age.
5.1 Prior Authorization
Medicaid shall require prior authorization for selected prescription drugs. Refer to
http://nctracks.nc.gov/
for a list of prescription drugs that require prior authorization
(PA). The website lists the medical necessity criteria for coverage for each medication
that requires prior approval. Refer to Attachment C for instructions on requesting prior
authorization.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 9
Medicaid may require prior approval for coverage of new to market and existing
products; and conduct clinical reviews for new to market products for possible
development of clinical coverage criteria. The clinical review includes:
a. new variations of products already in the marketplace;
b. new indications for products already in the marketplace;
c. changes in indications for products; and
d. or changes in dosing for products already in the marketplace.
Note: Time is needed to review scientific literature, consult with medical
specialists and peers to establish appropriate coverage criteria if prior approval is
determined to be necessary. In the interim, until appropriate clinical coverage
can be developed and approved, or until the state determines criteria is not
needed, coverage, including the coverage of Medicaid Managed Care Plans, shall
be based on FDA indications, FDA approved dosages, and medically acceptable
indications, and can involve prior approval. This guidance applies to new and
existing products for which Medicaid has not yet developed clinical coverage
criteria or determined criteria is not needed.
72-Hour Emergency Supply
A 72-hour emergency supply may be provided if a beneficiary is waiting for
acknowledgment of the prior authorization request. The pharmacy is reimbursed for the
supply if the prescription is changed to an alternative medication. Refer to Attachment C
for information on the processing of a 72-hour emergency supply.
5.1.1 Prior Authorization Process for Pharmacists Serving Long Term
Care Facilities
Pharmacists serving nursing facilities, adult care homes, and Intermediate Care
Facilities for Individuals with Intellectual Disabilities(ICF/IID) are allowed to
request prior authorization.
5.2 N.C. Medicaid Preferred Drug List
The N.C. General Assembly [Session Law 2009-451, Sections 10.66(a)-(d)] authorized
the establishment of the N.C. Medicaid Preferred Drug List (PDL), which allows the
Division of Health Benefits to obtain better prices for covered outpatient drugs through
supplemental rebates. All therapeutic drug classes for which the drug manufacturer
provides a supplemental rebate under the Medicaid program are considered for inclusion
on the list.
Refer to https://medicaid.ncdhhs.gov/
for more information about the NC Medicaid PDL.
5.3 Management of Polypharmacy and Low Adherence
A beneficiary with low adherence to chronic medications and polypharmacy shall be
referred to the Community Care of North Carolina Network for medication therapy
management to ensure coordinated care.
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5.4 Dispensing and Maximum Supply
The maximum supply for all drugs is a 34-day supply unless the medication meets the
criteria described below:
5.4.1 Birth Control and Hormone ReplacementTherapies
Up to 12 months of oral birth control medications and up to three months of
prepackaged hormone replacement therapies are allowed.
5.4.2 Non-Controlled Maintenance Medications
Medicaid beneficiaries may obtain a 90-day supply of medications if the claim is
for a non-controlled, maintenance medication.
This is at the sole discretion of the beneficiary’s health care provider. Only one
co-pay is collected and only one dispensing fee is paid for the 90-day supply.
5.4.3 Quantity and Episodic Drugs
Some drugs are meant to be used episodically and dispensed in quantities that
support less than daily use. NC Medicaid may impose quantity limitations for
episodic drugs based on advice from the North Carolina Physician Advisory
Group (NCPAG), which considers FDA labeling, evidence-based guidelines,
systematic reviews, and consultation with the DHHS designated contractor as to
North Carolina community and best practice standards about precise duration of
use.
The NCPAG may recommend for each drug that is designated as an episodic
drug other restrictions or actions currently available under the Outpatient
Pharmacy Program including:
a. Evaluating the applicability of quantity limitations of episodic drugs for a
beneficiary who normally receives their legend medications packaged in a
specialized distribution system;
b. Prior authorization criteria and requirements; and
c. Actions that minimize the number of dispensing fees for drugs that are
prescribed in limited quantities.
For quantity limitations refer to the Preferred Drug List or the specific Prior
Authorization policy found at http://www.nctracks.nc.gov/
NC Medicaid shall monitor utilization of designated episodic drugs on an annual
basis or more frequently, if necessary, in order to assess the need for changes in
the limits. This data is shared with the NCPAG.
5.5 Co-payments
5.5.1 Medicaid Co-payment Requirements
An eligible Medicaid beneficiary, who receives prescribed drugs, is required to
make a co-payment of $4.00 for each prescription received unless they are
exempt for one of the reasons listed below in Subsection 5.5.2. A provider may
not deny services to any Medicaid beneficiary because of the individual’s
inability to pay a deductible, coinsurance or co-payment amount. A provider may
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not willfully discount copays for a Medicaid beneficiary, and an individual’s
inability to pay does not eliminate his or her liability for the cost sharing charge.
The provider shall open an account for the beneficiary, collect the amount owed
at a later date, and document all attempts to collect the copay. If the account has
not been paid, the pharmacy may in the course of normal accounting principles,
write-off the charges and stop monitoring the claim.
5.5.2 Co-payment Exemptions
A Medicaid beneficiary is exempt from a co-payment for any one of the
following:
a. The beneficiary is under 21 years of age;
b. The beneficiary resides in a nursing home facility, Intermediate Care
Facilities for Individuals with Intellectual Disabilities (ICF/IID) or a mental
health hospital;
c. Adult care home and hospice beneficiaries are responsible for co-payment.
d. The drug is classified as family planning (birth control medication).
Exemption from the co-pay for family planning drugs is indicated on the
drug file and does not require any additional indicators. Do not collect a co-
pay for oral contraceptives;
e. The beneficiary is classified as a CAP beneficiary as indicated on the
beneficiary’s Medicaid Identification Card (MID card);
f. The beneficiary is pregnant. The co-payment exemption is made
automatically by the claims processing system for an eligible beneficiary. In
the event that the system does not override the copay, the pharmacy may use
any of the ICD-10-CM codes listed in Attachment J to indicate pregnancy;
g. A “4” in the Prior Authorization Type Code or a “2” in the pregnancy
indicator field on a point-of-sale (POS) claim also indicates an exemption
from the co-payment deduction for pregnancy;
h. The beneficiary is a member of a federally recognized tribe;
i. Vaccines and vaccine administration; or
j. Antiretrovirals used to reduce viral load in a beneficiary living with Human
Immunodeficiency Virus (HIV).
5.6 Returned Medication
Pharmacists shall follow the N.C. Board of Pharmacy regulations for returned
medications. A credit must be issued for all prescriptions that are allowed to be returned
to stock under N.C. Board of Pharmacy regulations. Credits must be handled by
completing a reversal of a Point-of-Sale (POS) claim.
Refer to Attachment A, Section K, Point-of-Sale Reversals; and Section O,
Resubmission of Rejected or Denied Claims, for additional information.
5.7 Automatic Refills and Shipments
Automatic refills and automatic shipments are not allowed. Medicaid shall not pay for
any prescription (original or refill) based on a provider’s auto refill policy. Medicaid shall
not pay for any prescription without an explicit request from a beneficiary or the
beneficiary’s responsible party, such as a caregiver, for each refilling event. The
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pharmacy provider shall not contact the beneficiary in an effort to initiate a refill unless it
is part of a good faith clinical effort to assess the beneficiary’s medication regimen. The
possession, by a provider, of a prescription with remaining refills authorized does not in
itself constitute a request to refill the prescription. A beneficiary or provider shall not
waive the explicit refill request and enroll in an electronic automatic refill program. Any
prescriptions filled without a request from a beneficiary or their responsible party are
subject to recovery. Any pharmacy provider with a policy that allows filling prescriptions
on a regular date or any type of cyclical procedure is subject to audit, claim recovery or
possible suspension or termination of their provider agreement. This does not prohibit a
pharmacy from using refill reminders to encourage a beneficiary’s adherence to their
medication regimen, as long as the reminders are for medications the beneficiary is
currently receiving.
5.8 Generic Substitution
Refer to Subsection 5.11 for information on Narrow Therapeutic Index (NTI) drugs.
The General Assembly authorizes and mandates pharmacists participating in Medicaid to
substitute generic drugs for brand or trade name drugs unless the prescriber specifically
orders the brand name drug. A prescription for a drug designated by a brand or trade
name for which one or more equivalent drugs are available is considered an order for the
drug by its generic name, except when the prescriber personally indicates in his or her
own handwriting on the prescription order “medically necessary.” Current Session Law
states:
“Dispensing of generic drugs. – Notwithstanding G.S. 90-85.27 through G.S. 90-
85.31, or any other law to the contrary, under the Medical Assistance Program (Title
XIX of the Social Security Act), and except as otherwise provided in this subsection
for drugs listed in the narrow therapeutic index, a prescription order for a drug
designated by a trade or brand name shall be considered to be an order for the drug
by its established or generic name, except when the prescriber has determined, at the
time the drug is prescribed, that the brand-name drug is medically necessary and has
written on the prescription order the phrase "medically necessary."
An initial prescription order for a Medicaid beneficiary that is for a drug listed in the
narrow therapeutic drug index that does not contain the phrase "medically
necessary" shall be considered an order for the drug by its established or generic
name, except that a pharmacy shall not substitute a generic or established name
prescription drug for subsequent brand or trade name prescription orders of the same
prescription drug without explicit oral or written approval of the prescriber given at
the time the order is filled. Generic drugs shall be dispensed at a lower cost to the
Medical Assistance Program rather than trade or brand-name drugs.
Notwithstanding this subdivision to the contrary, the Secretary of Health and Human
Services may prevent substitution of a generic equivalent drug, including a generic
equivalent that is on the state maximum allowable cost list, when the net cost to the
State of the brand-name drug, after consideration of all rebates, is less than the cost
of the generic equivalent. As used in this subsection, "brand name" means the
proprietary name the manufacturer places upon a drug product or on its container,
label, or wrapping at the time of packaging; and "established name" has the same
meaning as in section 502(e)(3) of the Federal Food, Drug, and Cosmetic Act, as
amended, 21 U.S.C. § 352(e)(3).
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The selection of a drug product must 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, unless a specific brand or trade
name is specified by the prescriber in the required manner or the net cost to the State
of the brand-name drug has been determined to be less than the cost of the generic
equivalent. NC Medicaid may use a certification form and procedures for
“medically necessary” brand-name drugs. For audit purposes, the brand name and
manufacturer must be documented on the prescription.
5.8.1 Generic Substitution for Brand Medically Necessary Medications
A prescription for a drug written under its brand or trade name must be filled
with a generic version of the drug when one is available unless the net cost to the
State of the brand-name drug has been determined to be less than the cost of the
generic equivalent OR the prescriber has indicated that the brand name drug is
medically necessary for the beneficiary to receive. The prescriber shall indicate
this by writing “medically necessary” on the prescription order for the drug. If
the pharmacist receives a prescription for a drug written by its brand or trade
name with the medical necessity documentation on the face of the prescription
even though there is a generic version of the drug available, the pharmacist shall
dispense the brand name drug. If the prescription is written by the brand or trade
name of the drug but “medically necessary” is not written on the face of the
prescription by the prescriber, the pharmacist shall dispense a generic version of
the drug.
NC Medicaid may impose prior authorization requirements on brand-name drugs
for which the phrase “medically necessary” is written on the prescription.
5.8.2 Generic Substitution for Narrow Therapeutic Index Drugs
A new prescription for a drug that is on the Narrow Therapeutic Index (NTI) list
that is written under its brand or trade name must be filled with a generic version
of the drug when one is available, unless the prescriber has indicated that the
brand name drug is necessary by writing “medically necessary” on the
prescription order for the drug. A prescription for a narrow therapeutic index
drug must be refilled using only the same drug product by the same manufacturer
that the pharmacist last dispensed under the prescription, unless the prescriber is
notified by the pharmacist prior to the dispensing of another manufacturer's
product, and the prescriber and the beneficiary give documented consent to the
dispensing of the other manufacturer's product. For purposes of this subsection,
the term "refilled" means a new prescription written at the expiration of a
prescription which continues the beneficiary's therapy on a narrow therapeutic
index drug. When utilizing a brand NTI drug in accordance with the rules above,
use Dispense as Written (DAW) 7 to indicate brand required and to override any
NADAC (National Average Drug Acquisition Cost ) generic rate or MAC.
5.9 Maximum Allowable Cost (MAC)
The Outpatient Pharmacy Program utilizes a state MAC list for generic and multi-source
brand drug products that do not have a NADAC brand or generic price. The
determination of which drug products are assigned a state MAC is the direct
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responsibility of NC Medicaid. The state MAC list contains mostly products with A-rated
equivalents, and in the great majority of cases, products marketed by at least two labelers.
The State’s MAC reimbursement is based on the application of a percentage factor
applied to the lowest priced generic. In cases where the calculated MAC rate, based on
the primary percentage factor, results in a price less than the cost of the second lowest
generic product, at least an additional 10 percent margin is added to the cost of the
second-lowest drug to establish the MAC price. The MAC pricing factor is set by NC
Medicaid and may change as deemed appropriate.
The additional margin is variable due to the wide range of differences in cost from
product to product.
For established generic drugs with only one supplier, the MAC price is established
between the actual acquisition cost and average wholesale price of the generic drug. A
minimum reimbursement of 20 percent above actual acquisition is guaranteed for these
drugs. In most cases, MAC pricing is substantially higher than this 20 percent, which
allows the State and pharmacies to share in the cost savings of using the generic product.
Drugs subjected to MAC pricing must be in adequate supply. Drug shortage information
is verified through the national pharmacy websites as well as through information
provided by national drug wholesalers.
The federal and state MAC lists work in conjunction with one another. The lowest price
at any given time will be the current reimbursement for a drug claim.
5.9.1 NADAC generic rate and MAC Override
It is possible to override either the NADAC generic rate or the state MAC
limitations if a prescriber certifies that a specific brand of drug, which has a
NADAC generic rate or MAC limitation, is medically necessary for a particular
beneficiary (refer to Subsection 5.8, Generic Substitution). This certification
must fall under federal and state regulations, which specify that the certification
“Medically Necessary” must be in the prescriber’s own handwriting and signed
by the prescriber. This can be written directly on the face of the prescription or
on a separate document, which must be attached to the original prescription.
Dispense as Written (DAW) 1 on a POS claim is a NADAC generic rate and
MAC override. NC Medicaid may impose prior authorization requirements on
brand-name drugs for which the phrase “medically necessary” is written on the
prescription.
Dispense as Written (DAW 7) on a POS claim is a NADAC generic rate and
MAC override. This override shall apply when a prescription for a drug on the
NTI list is written under its brand name and the prescriber has indicated the brand
name drug is necessary by writing “medically necessary” on the prescription
order. NC Medicaid may impose prior authorization requirements on brand-
name drugs for which the phrase “medically necessary” is written on the
prescription.
Dispense as Written (DAW 8) on a POS claim is a NADAC generic rate and
MAC override. This override shall be used only when a multi-source Brand
generic equivalent is not available in the marketplace. NC Medicaid may impose
prior authorization requirements on brand-name drugs for which the phrase
“medically necessary” is written on the prescription.
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Dispense as Written (DAW 9) on a POS claim is a NADAC generic and MAC
override. This override shall apply only to multi-source Brand drug products that
are preferred on the NC Medicaid PDL and have a nonpreferred generic
equivalent. NC Medicaid may impose prior authorization requirements on
brand-name drugs for which the phrase “medically necessary” is written on the
prescription.
5.9.2 Provider State MAC Inquiries
The North Carolina Medicaid Program contracts with a vendor in maintaining the
State Maximum Allowable Cost (State MAC) program for generic drugs and
hemophilia drugs.
Providers may contact the vendor regarding specific questions or concerns about
the State MAC rate, rate calculation process, changes in the acquisition cost of a
drug, changes in product availability, or to obtain a copy of the State MAC list.
Contact information is posted on the NC Medicaid website.
Providers with questions about a State MAC rate will be asked to complete a
“State MAC Pricing Inquiry Worksheet.” This request shall be completed by
providing the information requested and submitting copies of drug purchase
records which represent the current price paid for the particular drug(s) in
question.
Based on the information obtained, the vendor may conduct additional inquiries
with other pharmacies to obtain additional drug purchase records to determine if
there has been a change in the market. The vendor may also contact drug
manufacturer(s) to confirm any reports of market unavailability. After reviewing
the data submitted by the pharmacy, and any additional information obtained, the
vendor will prepare an analysis of the inquiry for review by NC Medicaid.
The results of NC Medicaid’s review will be communicated to the pharmacy as
soon as a final decision is made. If a rate adjustment is approved, a file will be
prepared to update the State MAC rate and its effective date in the pharmacy
claims processing and payment system.
5.9.3 Unacceptable Practices for Drugs with MAC Prices
a. The prescriber is not allowed to indicate “Medically Necessary” over the
telephone or e-prescription for the pharmacist to document on the
prescription if the drug is a MAC drug.
Note: If the drug is not a MAC drug, the pharmacist may receive oral
authorization not to substitute from the prescriber, write “Medically
Necessary” on the prescription, and initial it. If a telephone prescription or e-
prescription requiring brand only is accepted, the prescriber must send a new
prescription within 72 hours with “Medically Necessary” written on the
prescription in the prescriber’s own handwriting.
b. A prescriber’s signature over a printed statement indicating “Dispense as
Written” or “Medically Necessary” with a check or X in a box on the
prescription indicating “Dispense as Written” is unacceptable.
c. A handwritten statement transferred to a rubber stamp and then stamped on
the prescription is unacceptable.
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d. The abbreviation “DAW” on the prescription by the prescriber is
unacceptable.
If a physician has properly authorized for the dispensing of a brand name
drug product when that drug product is a MAC drug, the pharmacist can bill
for reimbursement based on the lower of the usual and customary charge or
the reimbursement rate of the brand name drug plus the dispensing fee. To
indicate that the prescriber has documented “Medically Necessary” and bill
for the brand, indicate DAW 1 on an online POS claim. Do not use DAW 1
for brand name, single source drugs. The MAC override must only be used to
override a MAC price.
5.9.4 Prenatal Vitamins
Due to the many variations in the ingredients in prenatal vitamins and the
corresponding variation in the ingredient cost, a single MAC rate for prenatal
vitamins is established and maintained. Current marketplace acquisition cost,
average wholesale price and wholesale acquisition cost are evaluated to
determine the single MAC rate. Prenatal Vitamins pay at NADAC rates first, but
when no NADAC is on file, the single MAC rate applies.
Refer to Attachment H for DAW codes.
5.10 Hemophilia Specialty Pharmacy Program
The General Assembly [Session Law 2012-142, Section 10.48(a2)] mandates that the N.C.
Medicaid Pharmacy programs establish a specialty pharmacy program for hemophilia
drugs. Refer to clinical coverage policy 9B, Hemophilia Specialty Pharmacy Program, at
https://medicaid.ncdhhs.gov/
.
5.11 Narrow Therapeutic Index Drugs
N.C. General Statute 90-85.27 defines Narrow Therapeutic Index (NTI) drugs to mean
those pharmaceuticals having a narrowly defined range between risk and benefit. Such
drugs have less than a twofold difference in the minimum toxic concentration and
minimum effective concentration in the blood or are those drug product formulations that
exhibit limited or erratic absorption, formulation-dependent bioavailability, and wide
intrapatient pharmacokinetic variability that requires blood-level monitoring.
Drugs identified as having narrow therapeutic indices are designated as NTI drugs by the
Secretary of the N.C. Department of Health and Human Services upon the advice of the
State Health Director, the N.C. Board of Pharmacy, and the N.C. Medical Board, and are
subject to the provisions of NCGS 90-85.28(b1).
The list of NTI drugs is reviewed on an annual basis and submitted to the Office of
Administrative Hearings by the N.C. Board of Pharmacy for publication in the N.C.
Register. Refer to Attachment D, Narrow Therapeutic Index Drugs, for the current list
of drugs designated as NTI. Refer to G.S. 90-85.27 through G.S. 90-85.31 in Subsection
5.8 for information regarding generic substitution, and Subsection 5.9.1 for information
regarding NADAC generic rate or MAC Overrides.
5.12 Billing for Partial Fills
Medicaid shall not pay for medications that the beneficiary has not received. Pharmacists
cannot issue an I owe you (IOU) to a beneficiary when the pharmacy is unable to
dispense the full amount of a prescription and then bill Medicaid for the total quantity of
the prescription. If the remaining quantity is not dispensed and the pharmacist has
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received payment for the total quantity prescribed, it is considered fraudulent and
appropriate action will be taken.
5.13 Incorrect Units for Unbreakable Packages
Billing inaccurate package sizes creates extra costs and delays for the Medicaid programs
when collecting drug rebates from manufacturers. Frequently, the quantity billed for
drops does not match the package size, such as, 5 ml is billed for the 10 ml NDC. Bill the
quantity that matches the package size for the NDC billed. If a different package size is
used for the refill, the prescription must be updated to match the drug dispensed with the
drug on the label, as is required by law.
The Outpatient Pharmacy Program accepts metric decimal quantities. The actual
manufacturer package size (or multiples of the package size) must be indicated on the
claim.
The table below shows some examples of NDCs and the correct corresponding package
size that must be used when billing these products. For example, Lovenox must be billed
in milliliters, so if 10 syringes are dispensed for the NDC indicated below, the metric
decimal quantity would be 6 ml.
NDC Drug
Metric Decimal
Quantity
00075150616
Nasacort AQ Nasal Spray
16.5
00597001314
Combivent Inhaler
14.7
00186107008
Rhinocort AQUA Nasal Spray
8.6
00075062160
Lovenox 60mg prefilled syringe
0.60
00013830304
Xalatan 0.005% Eye Drops
2.5
00069313019
Zithromax 200mg/5ml Suspension
22.5
00065064835
Tobradex Eye Ointment
3.5
00054309036
Butorphanol 10mg/ml Spray
2.5
00085113201
Proventil HFA 90 mcg Inhaler
6.7
61570003775
Viroptic 1% Eye Drops
7.5
5.14 Beneficiary Management Lock-In Program
The North Carolina Administrative Code, 10A NCAC 22F .0704 and 10A NCAC 22F
.0104, Session Law 2015-241, Section 12F.16.(l), along with 42 CFR 431.54 and the
State Plan Amendment supports the State’s development of procedures for the control of
beneficiary overutilization of Medicaid benefits which includes implementing a
Beneficiary Management Lock-In program. NC Medicaid has developed criteria for
inclusion in the Beneficiary Management Lock-In Program.
A Medicaid beneficiary identified for the lock-in program is restricted to a single
prescriber and pharmacy in order to obtain opioid analgesics and benzodiazepines. The
beneficiary may request two prescribers in the event one prescriber is responsible for
prescribing benzodiazepine medications and the other prescriber is responsible for
prescribing opiate medications or when both prescribers are practicing in the same clinic.
The beneficiary may request two separate pharmacies when one pharmacy dispenses
benzodiazepine medications, and the other pharmacy is responsible for dispensing opiate
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medications. A secondary pharmacy may also be allowed temporarily if the primary
pharmacy does not have the drug in stock. The beneficiary shall obtain all prescriptions
for these medications from their lock-in prescriber and lock-in pharmacy in order for the
claim to pay. Claims submitted that are written by a prescriber or filled at a pharmacy
other than those listed on the lock-in file are denied.
A beneficiary who qualifies for the program shall be notified and locked in for two years
after which time they shall be removed from the program. Once released from the lock-in
program, prescription claims continue to be monitored. If a beneficiary meets the criteria
again after being released from the program, they shall be re-identified for the lock-in
program. The beneficiary cannot change their lock-in prescriber or pharmacy without
authorization from NC Medicaid.
5.14.1 Inclusion in the Beneficiary Management Lock-In Program
A NC Medicaid beneficiary shall be locked-in to one prescriber and one
pharmacy for controlled substances categorized as opiates or benzodiazepines
when one or more of the following criteria are met:
a. Benzodiazepines: ten (10) or more claims in two (2) consecutive months
when not medically necessary.
b. Opiates: ten (10) or more claims in two (2) consecutive months when not
medically necessary.
c. Receiving prescriptions for opiates from four (4) or more prescribers in two
(2) consecutive months when not medically necessary.
d. Receiving prescriptions for benzodiazepines from four (4) or more prescribers
in two (2) consecutive months when not medically necessary.
5.14.2 Exclusions from the Beneficiary Management Lock-In Program
a. A beneficiary with certain cancer diagnoses within the last 12 months
b. A beneficiary with a living arrangement indicating they reside in a skilled
nursing facility
c. A beneficiary under the age of 18 years old
d. A beneficiary with a current hospice indicator on file
e. Drugs containing buprenorphine that are specifically indicated for the
treatment of OUD; and
f. A beneficiary with a diagnosis of sickle cell disease.
5.14.3 Emergency Supplies for the Beneficiary Management Lock-In
Program
The N.C. Medicaid Program shall reimburse an enrolled Medicaid pharmacy for
a four (4)-day supply of a prescription dispensed to a beneficiary locked into a
different pharmacy or prescriber in response to an emergent situation. The
provider shall be paid for the drug cost and a dispensing fee and the beneficiary
shall be responsible for the appropriate copayment. One emergency occurrence is
reimbursed per beneficiary during each year of the two (2) year lock-in period.
Paid quantities for more than a four (4)-day supply are subject to recoupment.
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6.0 Provider(s) Eligible to Bill for the Procedure, Product, or Service
To be eligible to bill for the procedure, product, or service related to this policy, the provider(s)
shall:
a. meet Medicaid qualifications for participation;
b. have a current and signed Department of Health and Human Services (DHHS) Provider
Administrative Participation Agreement; and
c. bill only for procedures, products, and services that are within the scope of their clinical
practice, as defined by the appropriate licensing entity.
6.1 Provider Qualifications and Occupational Licensing Entity Regulations
In order to participate in the Medicaid Outpatient Pharmacy Program, pharmacists shall
abide by the rules and regulations of the program, be in compliance with Title VI of the
Civil Rights Act, agree that NC Medicaid or its DHHS designated contractors may
conduct audits as necessary, and accept payment for covered services as payment in
full. Pharmacies shall operate under permit or license to dispense drugs issued by the
appropriate state or federal authority.
6.2 Filling Prescriptions
A provider of prescribed drugs shall file prescriptions numerically and in chronological
order, either in normally occurring order with other prescriptions filled by the provider or
in a separate file and each authorized refill must be recorded. Electronic versions of
prescriptions are acceptable if they can be readily retrieved and the electronic images are
retained according to the provider’s NC Medicaid enrollment agreement. Refer to
Subsection 7.2, Record Retention.
6.3 Changes in Pharmacy Status
Providers are responsible for notifying NC Medicaid within 30 calendar days when
information related to their business or practice changes. Refer to the NC Tracks website
at http://www.nctracks.nc.gov/provider/cis.html
or Medicaid’s website at
https://medicaid.ncdhhs.gov/ for the Provider Change form or Provider Enrollment
packet and additional information required for submission regarding the change if
applicable.
NC Medicaid shall be notified of the following changes:
a. Change of Ownership
The pharmacy shall apply for a new provider number and complete a new
participation agreement and Electronic Commerce Services agreement if there is an
ownership change of greater than 50 percent.
b. Change of Pharmacy Name and Tax Name
c. Change of Billing Address
d. Change of Site (physical location) Address
e. Change of Billing Contact Information or Site Contact (physical location)
Information such as
change of telephone number, fax number and e-mail
address.
f. Change to National Provider Identifier (NPI)
g. Change of Tax Number
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h. Change in Pharmacy Permit
i. Closing a Pharmacy or Voluntary Participation Termination
7.0 Additional Requirements
Note: Refer to Subsection 2.2.1 regarding EPSDT Exception to Policy Limitations for a
Medicaid Beneficiary under 21 Years of Age.
7.1 Compliance
Provider(s) shall comply with the following in effect at the time the service is rendered:
a. All applicable agreements, federal, state and local laws and regulations including the
Health Insurance Portability and Accountability Act (HIPAA) and record retention
requirements; and
b. All NC Medicaid’s clinical (medical) coverage policies, guidelines, policies, provider
manuals, implementation updates, and bulletins published by the Centers for
Medicare and Medicaid Services (CMS), DHHS, DHHS division(s) or fiscal
contractor(s).
7.2 Record Retention
Refer to the provider enrollment agreement for information on the record retention
requirements for the Medicaid program.
Pharmacy providers utilizing automated data processing systems as record keeping
systems shall be able to produce sight-readable documents of all original and refilled
prescription information. The term sight-readable means that a representative of the State
of North Carolina shall be able to examine the record and read the information from a
electronic source, or a hard-copy printout.
Medicaid records must be easily retrievable and kept on-site. Payments that cannot be
audited because records are not easily retrievable and on-site are subject to recoupment.
7.3 Pharmacy Audits
Pharmacy records are audited periodically. The purpose of these audits is to ensure that
the contractual agreement with NC Medicaid is being upheld. This contractual agreement
between the pharmacy provider and NC Medicaid requires that the provider agrees to:
a. file prescriptions numerically and in chronological order on-site, either in normally
occurring order with other prescriptions filled by the provider or in a separate file;
b. maintain as a permanent record on-site, an individual prescription for each drug
submitted for reimbursement;
c. maintain as a permanent record on-site, purchase invoices representing the cost paid
for all covered drugs and supplies reimbursed by NC Medicaid; and
d. follow rules published by the N.C. Board of Pharmacy for manual and computerized
record-keeping related to drug ordering, dispensing, filling, and refilling.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 21
7.4 Medicaid Recoupments
The Program Integrity Section conducts regular post payment reviews in an ongoing
attempt to ensure that Medicaid payments are made only for the services that are covered
under Medicaid policy. When overpayments are identified, the provider is given written
information about the errors and is required to refund the overpayment amount. It is vital
that providers use these overpayment notices to educate billing staff concerning the
importance of following policies. If additional billing guidance is needed, the provider
may request a visit from NC Medicaid’s fiscal agent’s Provider Services unit.
Overpayments are addressed in the following ways:
a. NC Medicaid shall seek restitution of any and all improper payments made to
providers by the Medicaid programs. Recovery may be by lump sum
payment, by a negotiated payment schedule not to exceed one (1) year or by
withholding from the provider’s pending claims the total or portion of the
recoupment amount.
b. A provider may argue all or a part of a recoupment imposed by NC Medicaid
by requesting a Reconsideration Review of the investigative findings and,
thereafter, an Executive Decision.
To keep recoupment amounts to a minimum, NC Medicaid encourages providers to refer
to the general bulletins and medical coverage policy information available on Medicaid’s
website at https://medicaid.ncdhhs.gov/
. If you or your staff have questions about the
policies or billings, it is vital to contact DHHS fiscal contractor’s Provider Services unit
at 800-688-6696.
Questions may be addressed to NC Medicaid’s Chief Hearing Officer at 919-814-
0090 or the NC Medicaid Office of Compliance and Program Integrity at
919-527-7700.
7.5 Emergency Preparedness Protocol
In the event of a state of emergency or disaster declared by the NC Governor, FEMA, or
the US President, the following protocol must be enacted at the direction of the NC
Secretary of Health and Human Services to prevent a significant disruption to the access
of life saving prescriptions medications for NC Medicaid beneficiaries:
a. Waive utilization management requirements (that is PAs where applicable) and lift
“refill -too -soon” edits.
b. Allow an affected enrollee to obtain the maximum extended day supply, if requested
and available at the time of refill.
Once the Emergency Preparedness Protocol is enacted, NC Medicaid enrolled pharmacy
providers shall submit these pharmacy claims with “09” (Emergency Preparedness) in the
PA Type Code field and a valid value for an E.R override in the Reason for Service,
Professional Service and Result of Service fields to override a denial for an early refill.
Values cannot be placed in the Submission Clarification Code field. This early refill
override for emergency preparedness is allowed for all medications. Co-pay requirements
are also applicable to these pharmacy claims. The use of this override is allowed while
the state of emergency order remains in place.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 22
8.0 Policy Implementation/Revision Information
Original Effective Date: January 1, 1999
Revision Information:
Date
Section Revised
Change
09/01/2005
All sections and
attachment(s)
Changes were made throughout the policy to correspond with
approved amendments to the State Plan.
11/01/2005
Subsection 5.6.1 and
Attachment G
Co-payment information was updated to reflect a change in
the State Plan.
12/01/2005
Subsection 2.2
The Web address for DMA’s EDPST policy instructions was
added to this section.
02/01/2006
Attachment A
Billing information for drugs covered under hospice was
added to the attachment as section I and the remainder of the
attachment was renumbered accordingly.
05/01/2006
Subsection 4.1 and
Attachment G
Erectile dysfunctions drugs and anorexia, weight loss and
weight gain drugs were added to the list of non -covered
services in compliance with mandated legislation.
05/01/2006
Subsection 5.2.3
Information regarding how to bill for drugs that are packaged
in an unbreakable package was clarified.
05/01/2006
Subsection 5.2.4
Service requirements for Quantity and Episodic Drugs were
added to the policy.
05/01/2006
Attachments A, Item
G
Information regarding cost avoidance claims processing was
clarified.
05/01/2006
Attachment P
The list of Episodic Drugs Quantity Dispensing Limits was
added to the policy
06/01/2006
Subsection 5.1, 5.1.1,
and 5.1.2
The established limit of six prescriptions per month was
deleted. Policy requirements associated with the new
prescription limit including the medication therapy
management program requirements were added to the policy.
06/01/2006
Subsection 5.3
This section pertaining to the recipient opt-in program was
deleted and replaced with section 5.1.3.
06/01/2006
Subsection 5.4
This section pertaining to the establishment of a pharmacy of
record was deleted from the policy.
06/01/2006
Attachment A,
Section E
Procedural information related to the six prescription
payment for the pharmacy of record was deleted from the
policy and the remaining sections were renumbered
accordingly.
06/01/2006
Attachment A,
Section Q.5
Information related to pharmacy of record adjustment
requests was deleted from the policy.
06/01/2006
Attachment A,
Section R
Procedural information related to exemptions from the
prescription limitation was added to the policy.
06/01/2006
Attachment A,
Section S
Information related to the recipient opt-in program was added
to the policy.
06/01/2006
Attachment A,
Section T
Information related to the Medication Management Fee was
added to the policy.
06/01/2006
Attachment B
The Six-Prescription Limit Override form was deleted from
the policy.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 23
Date
Section Revised
Change
07/01/2006
Throughout
The term “dispensing fee” changed to “professional services
fee.”
07/01/2006
Subsection 5.1.1
The first sentence was revised to indicate that pharmacists
may override the monthly prescription limit with three
additional prescriptions per recipient per month for recipients
aged 21 and older. The second sentence was revised to
indicate that the decision to override the monthly prescription
limit is at the discretion of the pharmacist and does not
require consultation with the recipient’s physician.
07/01/2006
Subsection 5.1.3
The sentence pertaining to the systematic removal of
recipients from the Opt-in Program was rewritten to clarify
the process.
07/01/2006
Subsection 7.1 and
7.2
Clarification was added to indicate that pharmacy records
must be maintained on-site.
07/01/2006
Subsection 7.3
The phone number for the DMA Pharmacy Review Officer
was corrected.
12/01/2006
Subsection 2.2
The special provision related to EPSDT was revised.
12/01/2006
Sections 3.0, 4.0, and
5.0
A note regarding EPSDT was added to these sections.
03/01/2007
Attachment A,
Section H
A requirement for the ICD-9-CM code to appear at the
bottom of the form was added.
03/01/2007
Subsection 5.8.1 and
Attachment A,
Section I
Removed references to NCPDP 1.1 batch billing
03/01/2007
Attachment A,
Section I
Added a requirement to bill claims over $9,999.00 on paper
05/01/2007
Subsection 5.6
Information regarding prescription drugs requiring prior
approval was clarified.
05/01/2007
Subsections 5.7 and
5.7.1
Clarified paragraphs regarding North Carolina law.
05/01/2007
Sections 2 through 5
EPSDT information was revised to clarify exceptions to
policy limitations for recipients under 21 years of age.
08/01/2007
Subsection 5.1,
subsections 1
through 4;
Attachment A
Changed references to Medication Therapy Management
Program to Focused Risk Management (FORM) Program;
updated requirements.
08/01/2007
Subsection 5.1.3
Clarified parameters for removal from the opt-in program.
08/01/2007
Subsection 5.1.5
Added new section on FORM process oversight.
08/01/2007
All sections and
attachment(s)
Changed “professional services fee” to “dispensing fee.”
08/01/2007
Attachment A, S.2
Updated contact information.
11/01/2007
Subsection 5.7
Added the information that DMA may use a certification
form and procedures for medically necessary brand-name
drugs.
11/01/2007
Attachments A and F
Added clarification for claims submitted by 340B providers.
11/01/2007
Attachment A, letter
I
Added narcotic analgesics and narcotic analgesic
combination drugs to the list of those that don’t allow a
hospice edit override.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 24
Date
Section Revised
Change
11/01/2007
Attachment E, E.3
Changed last paragraph to read “… except in three areas:”
and added the third item (letter c).
01/01/2008
Subsections 5.1.2,
5.1.3
Added the word “unduplicated” to references to 11 or 12
prescriptions.
07/01/2008
Subsection 2.2
Added legal citation for EPSDT information.
07/01/2008
Subsection 4.2
Added drug samples and drugs obtained from patient
assistance programs to non-covered services.
10/10/2008
Subsection 5.9;
Attachment A,
subsections B.3, B.5,
and G
Added instructions for the Enhanced Specialty Discount
Drug List; renumbered old subsections 5.9 through 5.12 to
5.10 through 5.13.
02/01/2009
(eff.
04/01/2008)
Attachment N
Revised description of Prescription Advantage List.
05/01/2009
Attachment D
Added tacrolimus to the list of Narrow Therapeutic Index
drugs.
06/01/2009
(eff.
05/22/2009)
Attachment H
Added DAW 8 to the list of codes for dispense as written.
06/01/2009
Attachment J
In the Note to Item 5, corrected “six-prescription limitation”
to “eight-prescription limitation.” This is a correction of an
oversight, not a change in policy.
06/01/2009
Attachment O
Added Zolpidem and Zaleplon to their respective drug
classes; deleted GCN14281 from the Halcion and Triazolam
row. This is a correction of an oversight, not a change in
policy.
08/01/2009
Attachment H
Added prescription origin codes.
08/01/2009
Attachment O
Added triptans to the episodic drug list.
10/05/2009
Subsection 5.8 and
Attachment A, item
B.4
The maximum allowable cost was change from 150% to
190% of the lowest priced generic.
10/05/2009
Attachment A, item
B.3
Methodology for the cost of the drug was changed from the
Average Wholesale Price - 10% to the WAC + 7 percent; the
federal or state MAC price; the enhanced specialty discount,
if applicable; or the usual and customary charge and to
indicate that WACs are updated weekly via File Transfer
Protocol (FTP) from First Data Bank.
10/05/2009
Attachment F, item
h.
The calculated Medicaid price was changed from the MAC
price or Average Wholesale Price - 10 % to the MAC price or
the WAC + 7% + the dispensing fee.
12/01/2009
Subsection 4.2
Added o: Drugs used for the symptomatic relief of cough and
colds that contain expectorants or cough suppressants
12/01/2009
Attachment F, k.
Added t: Drugs used for the symptomatic relief of cough and
colds that contain expectorants or cough suppressants
07/01/2010
All sections and
attachment(s)
Policy Conversion: Implementation of Session Law 2009-
451, Section 10.32 “NC HEALTH
CHOICE/PROCEDURES FOR CHANGING MEDICAL
POLICY.”
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 25
Date
Section Revised
Change
08/15/2010
Attachment E
Revised following sections to limit use of 04 Lost
Prescription override code to one occurrence on one date of
service each 365-day time period: C.2., G.6.j., G.9., G.10.
Overutilization (ER).
Corrected the word “Point” in the title of section G.
08/26/2010
Subsection 5.14
Implementation of Recipient Management Lock-In Program.
Added sections 5.14 - 5.14.3.
08/31/2010
Section 8.0
Implementation Table updates
09/14/2010
Header
Corrected revised date to August 26,2010
12/15/2010
Subsection 5.1.2
Eliminate Focused Risk Management (FORM) Program
12/15/2010
Subsection 5.1.3
Delete reference to FORM
12/15/2010
Subsection 5.1.5
Eliminate FORM Process oversight
12/15/2010
Attachment A (S.1)
Delete reference to FORM
12/15/2010
Attachment A (T.)
Delete Professional Services Fee for FORM program
12/15/2010
Subsection 5.2.4.c
Delete reference to Prescription Advantage List
12/15/2010
Subsection 5.6
Subsection 5.6 Prescription Drugs Requiring Prior
Authorization moved to Subsection 5.1 Prior Approval
12/15/2010
Subsection 5.7
Updated section with new legislative language to allow
substitution of a brand name drug when the net cost of the
brand name drug is less than the generic version
12/15/2010
Subsection 5.7.1
Updated section with new legislative language to allow
substitution of a brand name drug when the net cost of the
brand name drug is less than the generic version
12/15/2010
Subsection 5.7.2
Removed atypical antipsychotics from this section
12/15/2010
Subsection 5.8.1
Added language to allow prior authorization on brand-name
medically necessary drugs (DAW1)
12/15/2010
Subsection 5.13
Eliminate Prescription Advantage List
12/15/2010
Subsection 7.2
Removed reference to 5 year record retention requirement
and inserted reference to Basic Medicaid Billing Guide for
record retention policy
12/15/2010
Subsection 7.3
Removed reference to 5 year record retention requirement
12/15/2010
Attachment E, E.3
Patient Counseling -
Impact on
Pharmacies (d.)
Removed reference to 5 year record retention requirement
12/15/2010
Attachment N
Eliminate Prescription Advantage List
04/13/2011
Subsection 4.2
Added: All legend vitamins and mineral products, except
prenatal vitamins and fluoride
04/13/2011
Attachment F
Added: All legend vitamins and mineral products, except
prenatal vitamins and fluoride
01/01/2012
Subsection 5.7
Added: Automatic Refills
01/01/2012
Attachment A
Added: C8 Claims Processing for Selected DME Products
01/01/2012
Attachment A
Removed: K Billing for Allergy Vaccines
01/01/2012
Attachment E
Added: Only one 5-consecutive day occurrence each 365-day
time period will be allowed for non-controlled medications
TO C2, G6, G9 and G10.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 26
Date
Section Revised
Change
03/12/2012
All sections and
attachment(s)
To be equivalent where applicable to NC DMA’s Clinical
Coverage Policy #1A-5 under Session Law 2011-145,
Section 10.41(b).
05/01/2012
Subsection 5.9
Updated the State Maximum Allowable Cost (SMAC)
language
05/01/2012
Subsection 5.9.3
Add Prenatal Vitamins to the SMAC section
05/01/2012
Attachment A, B.4
Updated the State Maximum Allowable Cost (SMAC)
language
05/01/2012
Attachment B
Updated attachment to reflect NCPDP D.0
05/01/2012
Attachment H
Updated attachment to reflect NCPDP D.0
08/16/2012
Attachment A
Removed specific rates on dispensing fees, effective
2/1/2012. Added link to State Plan,
(
http://www.ncdhhs.gov/dma/plan/) Attachment 4.19-B,
Section 12, Page 1a for dispensing fees.
08/16/2012
Attachment A
Added link to NCEAC website, State Plan,
(http://www.ncdhhs.gov/dma/plan/) Attachment 4.19-B,
Section 12, Page 1a
08/16/2012
Attachment F
Removed WAC +7%, effective 2/1/2012. Added NCEAC.
01/31/2013
All sections and
attachment(s)
Changed recipient to beneficiary
01/31/2013
All sections and
attachment(s)
Changed DUR alert titles to new ones under NCPDP D.0
01/31/2013
Subsection 5.1
Removed reference to terminated Clinical Coverage Policy
No. 9B, Prior Authorization for Outpatient Pharmacy Point
of Sale Medications.
01/31/2013
Subsection 5.11
Added new section 5.11 Hemophilia Specialty Pharmacy
Program
01/31/2013
Attachment A, B.3
Added references to new Hemophilia Specialty Pharmacy
program
01/31/2013
Attachment A, B.6
Added new section B.6 Hemophilia Specialty Pharmacy
Program
01/31/2013
Attachment F, g.
Added reference to new Hemophilia Specialty Pharmacy
Program
02/07/2013
Subsection 5.3
Removed Subsection 5.3 Prescription Limitations
02/07/2013
Subsection 5.3
(New)
Added new Subsection 5.3 for CCNC medication
therapy management for polypharmacy and low
adherence
02/07/2013
Attachment A, C.2.b
Removed reference to prescription limitations
02/07/2013
Attachment A, H.
Removed reference to prescription limitations
02/07/2013
Attachment A, I.
Removed reference to prescription limitations
02/07/2013
Attachment A, Q
Removed indicating exemption from the prescription
limitations
02/07/2013
Attachment A, R.1 –
R.3
Removed Recipient Opt-In program sections
02/07/2013
Attachment B
Removed references to prescription limitations
02/07/2013
Attachment H
Removed references to prescription limitations
02/07/2013
Attachment J
Removed references to prescription limitations
02/07/2013
Attachment K
Removed references to prescription limitations
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 27
Date
Section Revised
Change
07/01/2013
All sections and
attachment(s)
Removed references to paper billing, manual claims, and
Pharmacy Adjustment Claim Forms
07/01/2013
All sections and
attachment(s)
Removed references to Hewlett Packard, (HP) or ACS/Xerox
and replaced them with Computer Science Corp., (CSC)
07/01/2013
Attachment A, C.1
Removed Requesting Online Point-of-Sale for Pharmacy
Claims
07/01/2013
Attachment A, C.2
Amended Online Point of Sale Processing Hours to Online
Point of Sale Down Time
07/01/2013
Attachment A, C.3
Amended Placeholder for Compound Prescriptions Claims on
Point-of-Sale to Compound Prescription Claims on Point-of-
Sale
07/01/2013
Attachment A, C.4
Amended Point-of –Sale Claims over $9,999
07/01/2013
Attachment I
Removed entire attachment: Pharmacy Online Request for
Medicaid and NCHC Claims
07/01/2013
Attachments J, J-1, J-
2
Removed entire attachments: Instructions for Completing the
manual Pharmacy Claim Form, Example of Manual Claims
Form, and Example of Manual Claim Form for Compound
Drug
07/01/2013
Attachment K
Removed entire attachment: Completing the Pharmacy
Adjustment Request Form
07/01/2013
Attachment L
Renumbered to now become Attachment I with the deletions
to Attachments I, J, K. Updated references throughout the
policy to reflect this change.
07/01/2013
Attachment I
Amended Pharmacy Remittance Advice (RA)
07/01/2013
Attachment H
Added Origin Code: 5 - Pharmacy
10/01/2015
All Sections and
Attachments
Updated policy template language and added ICD-10 codes
to comply with federally mandated 10/1/2015
implementation where applicable.
10/01/2016
All Sections and
attachments
Updated pricing guidelines around National Average Drug
Acquisition Cost (NADAC) pricing
10/01/2016
Section 3.4
Changed NDC to be require on claims
10/01/2016
Section 4.2.1
Added Vitamin-D and vaccines as covered items
10/01/2016
Section 5.2
Clarified PDL webpage information
10/01/2016
Section 5.4.1
Removed 90 days supply requirement for Depo-Provera
10/01/2016
Section 5.5.1
Clarified Medicaid Co-Payment Requirements
10/01/2016
Section 5.5.2
Corrected Co-payment Exemptions for Medicaid
Beneficiaries
10/01/2016
Section 5.8.2
Clarified Generic Substitution for Narrow Therapeutic Index
Drugs
10/01/2016
Section 5.10
Eliminated Enhanced Specialty Discount on Single Source
Specialty Drugs
10/01/2016
Section 5.15
Section changed to 5.14 and Updated Beneficiary
Management Lock-In Program
10/01/2016
Section 5.15.3
Eliminated Beneficiary Management Lock-In Oversight
10/01/2016
Section 7.4
Updated Medicaid and NCHC Recoupments
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 28
Date
Section Revised
Change
10/01/2016
Attachment A
Removed Section B.5 Enhanced Specialty Discount Drug
List; Defined Section E.1 Full Dual Eligible Beneficiaries;
Added Section E.2 QMB Beneficiaries; Updated Section F.
Billing Remainder of a Third-Party Prescription to Medicaid;
Updated Section I. Billing for Drugs Covered under Hospice;
Added Vaccine billing procedures
05/01/2017
Attachment E
Added language regarding change in early refill alert for
benzodiazepines and opioid analgesics
05/01/2017
Section 5.7
Added reminder that pharmacies may use refill reminders to
encourage a beneficiary’s adherence to their medication
regimen for medications the beneficiary is currently taking
06/01/2017
All Sections and
Attachments
Policy posted 06/01/2017 with an Amended Date of
05/01/2017
11/01/2018
Section 4.2.1(b)
Added language to reference exception to Rebate agreement
requirement for CroFab
11/01/2018
Section 4.2.1 (g)
Added description for the living arrangement codes
11/01/2018
Section 5.9
Added Provider State MAC Inquiries as 5.9.2 under section
5.9 Maximum Allowable Cost (MAC)
11/01/2018
Section 5.9.2 (a)
Added e-prescribing to language; Section 5.9.2 amended to
5.9.3
11/01/2018
Section 5.9.3
Amended to 5.9.4
11/01/2018
Section 7.5
Added new Subsection “Emergency Preparedness Protocol”
11/01/2018
Section 4.2.1(a) and
(m)
Change to Refer to Subsection 3.2.1(b)
11/01/2018
Section 4.2.1(m)
Removed the word “and” in last sentence
11/01/2018
Section 5.4
Remove words Days and days’
11/01/2018
Section 5.4.3 second
paragraph
Removed “but not limited to”
11/01/2018
Section 5.5.2 first
sentence
Removed the word “any”
11/01/2018
All sections and
attachments
Replaced “recipient” with “beneficiary”
11/01/2018
All sections and
attachments
Replace “patient(s)” with “beneficiary”
11/01/2018
All sections and
attachments
Replaced “DMA” with “NC Medicaid”
11/01/2018
Attachment E F.1
Changed days’ to day
11/01/2018
Section 3.2.1
Removed word of
11/01/2018
Section 6.2
Replaced as long as with if
11/01/2018
Section 5.1
Added sentence Medicaid and NCHC shall require prior
authorization for selected prescription drugs.
11/15/2018
All sections and
attachments
Policy posted on this date, with an Amended Date of
November 1, 2018
7/22/2019
Subsection 3.2.1
Add clarification related FDA indication of drugs,
7/22/2019
Subsection 5.5.2
Add copay exemption for federally recognized tribal
members
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 29
Date
Section Revised
Change
7/22/2019
Subsection 7.3
Remove “on-site” related to audits and add requirement for
maintaining invoices as a permanent record.
7/22/2019
Subsection 5.9.1
NADAC generic rate and MAC override - Added DAW 7,
DAW 8, DAW 9
7/22/2019
Subsection 6.2
Filling Prescriptions- Replaced record retention policy with
provider’s enrollment agreement
7/22/2019
Subsection 7.2
Record Retention - Removed “refer to NCTracks Claims
and Billing Guide” and corresponding link and “current
information; replace with provider enrollment agreement
7/22/2019
Attachment A B4
Revised “340B Provision as It Pertains to the Cost for the
Drug” to remove all “plus the dispensing fee” and reference
to Medicaid website for state upper limits for 340B
purchased hemophilia drugs
7/22/2019
Attachment A C1
Revised A.1 Obtaining Point-of-Sale Software from a
Vendor
to add “Override MAC prices with DAW 9” (insert as d;
previous d became e.)
7/22/2019
Attachment F (g)
Revised 340B Provisions to remove all “plus the dispensing
fee” and reference to Medicaid website for state upper limits
for 340B purchased hemophilia drugs
7/22/2019
Attachment F (h)
Created 1-4 format for when NADAC generic rate and
MAC overrides are allowed to include DAW 7 DAW 8 and
DAW9
7/22/2019
Attachment H (3)
Added to “Dispense as written codes currently” DAW codes
2, 3, 4, 6, 9 with descriptions
7/22/2019
Footer and
Attachment A
Remove Public Comment from footer in page 41 through
71; and remove underline in attachment A
01/13/2020
Table of Contents
Updated policy template language, “To all beneficiaries
enrolled in a Prepaid Health Plan (PHP): for questions about
benefits and services available on or after implementation,
please contact your PHP.”
01/13/2020
Attachment A
Added, “Unless directed otherwise, Institutional Claims
must be billed according to the National Uniform Billing
Guidelines. All claims must comply with National Coding
Guidelines”.
05/07/2021
Section 5.1, Section
5.4.3 and
Attachment K
List of Pharmacy Prior Approval Drugs and Criteria added
in Attachment K; links updated to NC Medicaid Website
throughout policy from NC Tracks. No change made to
Amended Date
07/1/2021
Sections 5.4, 5.41,
5.42 and
Attachment F
Allowing coverage of claims for up to 12 months supply of
oral birth control products and for claims for up to a 90 day
supply of maintenance medications.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 30
Date
Section Revised
Change
06/15/2022
Section 5.14
Clarification of current operational procedures for
beneficiary selection, choice of providers and eliminating
the word “anxiolytics” as the drugs in this category are now
listed with GC3 for benzodiazepines.
06/15/2022
Policy posted 06/23/2022 with an amended date of
06/15/2022
10/01/2022
Section 5.5.1
Medicaid prescription copay changed to $4.00
10/01/2022
Section 5.5.3
Federal Family Poverty Limits changed for NCHC and
Class L of NCHC beneficiaries removed
10/01/2022
Section 5.14
Documenting current operational procedures for the lock-in
program regarding drugs excluded from the program
10/01/2022
Policy posted with and amended date of 10/01/222 with an
effective date of 7/1/22
4/15/2023
All Sections and
Attachment(s)
Updated policy template language due to North Carolina
Health Choice Program’s move to Medicaid. Policy posted
4/15/2023 with an effective date of 4/1/2023.
07/15/2024
Section 3.2.1
Added “unless approval is given by DHB” to clarify that
the drug given must be used for FDA indications unless
approved by DHB
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 31
Date
Section Revised
Change
07/15/2024
Section 3.2.2
Added new section with some paragraphs moved from 3.2.1
Section 1927(d)(1)(B)(i) of the Social Security Act allows
Medicaid to restrict coverage for an outpatient drug if the
prescribed drug is not for a medically accepted indication.
Section 1927(k)(6) defines a medically accepted indication
as any use for a covered outpatient drug, which approved
under the Federal Food, Drug, and Cosmetic Act, or the use
of which is supported by one or more citations included or
approved for inclusion in any of the compendia:
a. American Hospital
Formulary Service Drug
Information
b. United States Pharmacopeia; or
c. DRUGDEX Information System; or
d. As per 1927(d)(1)(B)(ii), peer-reviewed medical
literature
Providers who determine that the indication or dosing for a
particular drug is medically necessary for a beneficiary, but
those parameters fall outside of the FDA approved
guidelines and evidence-based standards for that drug or NC
Medicaid Drug Criteria for that drug, may make a request
for the medically necessary indication or dosing for a
particular drug.
In order to request approval, providers must submit, along
with the usual drug request forms the required additional
information:
Medical record information to show medical necessity for
the requested drug;
An explanation of what other drugs have been tried or why
they cannot be tried;
An explanation from the prescribing medical professional of
why the FDA approved guidelines and evidence-based
standards for that drug or NC Medicaid Drug Criteria is
insufficient for this patient; and
Compendia/peer-reviewed medical literature supporting the
use of the requested drug (as per 42U.S.C. 1396r
8(g)(1)(B)).
07/15/2024
Section 5.1
Added interim procedure for new to market drugs for fee for
service and managed care plans.
07/15/2024
5.5.2
Added vaccine and vaccine administration as exempt from
copay and Antiretrovirals used to reduce viral load in
members living with HIV
07/15/2024
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
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Date
Section Revised
Change
07/15/2024
5.14.1
Change the criteria for inclusion into the lock-in program
from 6 or more claims to 10 or more claims and from 3 or
more prescribers to 4 or more and when utilization has been
determined as not medically necessary in compliance with
Session Law 2023-134 House Bill 259.
07/15/2024
Section 5.14.3
Remove verbiage stating that payment will be made only for
the drug for emergency fills as they will now reimburse per
standard emergency fill logic with a dispensing fee
07/15/2024
Section 7.2
Removed CRT, microfiche and microfilm from record
retention requirements and replaced with electronic source
07/15/2024
Section 8.0
Added section 8.0 Drug Donation
07/15/2024
Section 8.1
Added section 8.1 Long Acting Injectable Antipsychotics
(LAIs)
07/15/2024
Attachment A B.1
Added point of sale option for billing vaccines
07/15/2024
Attachment A B.2
Added sentence stating “a dispensing fee, or professional
fee, shall be paid per each covered outpatient prescription.”
Removed previous dispensing fee logic for brand and
generic drugs and replaced with the Cost of Dispensing
study
Removed dispensing fee deduction for repeat drugs in the
same calendar month
07/15/2024
Attachment A B.3
Removed subsequent section containing the definition of
repeat or refill drugs in the same month of service
07/15/2024
Attachment A B.4
Added “The following 340B guidelines apply to the
following entities:
-Covered Entities billing as Outpatient Pharmacy Point-of
sale
-Contract Pharmacies
-Fee-for-service
-Managed Care
-Out-of-state Pharmacy Point-of -sale Providers
-Any other entity billing Pharmacy point-of-sale for 340B
drugs”
07/15/2024
Attachment C-e
Removed “and only the drug cost will be reimbursed.”
07/15/2024
Attachment E D.2
Changed DEA to NPI
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
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Date
Section Revised
Change
07/15/2024
Attachment F-g
Added The following 340B guidelines apply to the
following entities:
-Covered Entities billing as Outpatient Pharmacy
Point-of sale
-Contract Pharmacies
-Fee-for-service
-Managed Care
-Out-of-state Pharmacy Point-of -sale Providers
-Any other entity billing Pharmacy Point-of -sale for
340B drugs
Added The state will then extract appropriate claims from
rebate invoicing and collection.
The following 340B guidelines apply to the following
entities:
-Providers billing drugs through the Physicians’ Drug
Program
340B providers must be listed on the HRSA website
(http://www.hrsa.gov/opa/).
For 340-B drugs, provider(s) shall bill the cost that is
reflective of their acquisition cost. Provider(s) shall indicate
that a drug was purchased under a 340-B purchasing
agreement by appending the “UD” modifier on the drug
detail.
The state will then extract appropriate claims from rebate
invoicing and collection. This will eliminate duplicate
discounts as the claims will be pulled from rebate
collections.
The following 340B guidelines apply to the following
entities:
-Outpatient Hospitals
340B providers must be listed on the HRSA website
(http://www.hrsa.gov/opa/).
Outpatient Hospitals are reimbursed based on a ratio of cost
to charge. Outpatient Hospitals should submit Usual and
Customary charge (rather than the actual acquisition cost)
for 340B medications on the UB-04 and 837i. 340B status
should be indicated on the UB-04 and 837i using the UD
modifier for outpatient hospital institutional medical drug
claims (O claims).
The state will then extract appropriate claims from rebate
invoicing and collection. This will eliminate duplicate
discounts as the claims will be pulled from rebate
collections .Providers may be responsible for any adverse
financial impact to the State for erroneously billed claims.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 34
Date
Section Revised
Change
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 35
Attachment A: Claims-Related Information
Provider(s) shall comply with the, NCTracks Provider Claims and Billing Assistance Guide, Medicaid
bulletins, fee schedules, NC Medicaid’s clinical coverage policies and any other relevant documents for
specific coverage and reimbursement for Medicaid:
A. General Information
Each time Medicaid services are rendered, the provider must verify the beneficiary’s eligibility on the
date of service through a point-of-sale E1 transaction or through the Eligibility Verification System
for proof of eligibility. The prescription must be verified for coverage. All claim fields must be
completed. The pharmacist shall retain a copy of the claim on file.
Refer to Attachment F for a summary of the billing requirements.
Unless directed otherwise, Institutional Claims must be billed according to the National Uniform
Billing Guidelines. All claims must comply with National Coding Guidelines.
B. Directions for Drug Reimbursement
Reimbursement is determined using the cost per unit times the quantity dispensed plus the dispensing
fee. Reimbursement is limited to the applicable price in effect on the date of service, not on the date
of payment. Refer to Section B.4, Cost of the Drug.
B.1 Vaccines
Vaccines can be billed using a professional claim with the appropriate CPT codes and
the pharmacy shall use their NPI and proper taxonomy to bill vaccines. Vaccines can be
billed also at the point-of-sale.
B.2 Dispensing Fee
A dispensing fee, or professional fee, is paid per each covered outpatient prescription.
The dispensing fee for generic drugs or brand name drugs is based on the Cost of Dispensing
study conducted on behalf of the North Carolina Department of Health and Human Services,
Division of Health Benefits on NC Medicaid’s website at https://medicaid.ncdhhs.gov/
Changes in the dispensing fee amount are reported in the NC Medicaid Pharmacy Newsletters
or on Remittance Advice (RA) banner messages.
B.3 Cost of the Drug
Cost data is currently being obtained from First Data Bank. The cost of the drug is calculated
from the North Carolina Average Acquisition Cost (AAC); North Carolina shall base brand and
generic drug ingredient pricing on an average acquisition cost (AAC). The AAC is defined as
the price paid by pharmacies based on an average of actual acquisition costs determined by a
survey of retail pharmacy providers. The National Average Drug Acquisition Cost (NADAC)
pricing must be used for AAC when available and the lessor of NADAC or Usual and
Customary & Reasonable Charges (UCR) determines the cost of the drug.
If NADAC is unavailable, then the AAC is defined as Wholesale Acquisition Cost (WAC). If
WAC is used then the lessor of WAC; the state MAC price; the hemophilia enhanced specialty
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 36
discount, if applicable; or the UCR determines the cost of the drug. WACs are updated weekly
via File Transfer Protocol (FTP) from First Data Bank. State MACs are updated monthly.
The state MAC lists and the hemophilia enhanced specialty discount list are published on
Medicaid’s website at https://medicaid.ncdhhs.gov/. The A
AC is available in the State Plan,
Attachment 4.19-B, Section 12, Page 1a, on NC Medicaid’s website at
https://medicaid.ncdhhs.gov/
.
340B Provision as It Pertains to the Cost for the Drug
The following 340B guidelines apply to all of the following entities:
a. Covered Entities billing as Outpatient Pharmacy Point-of sale;
b. Contract Pharmacies;
c. Fee-for-service;
d. Managed Care;
e. Out-of-state Pharmacy Point-of -sale Providers; and
f. Any other entity billing for 340B Outpatient Pharmacy Point-of sale drugs.
340B providers must be listed on the HRSA website (http://www.hrsa.gov/opa/
). 340B
providers must submit the actual purchased drug price in the usual and customary charge field.
Providers who maintain two separate inventories—one for the 340B beneficiaries and a
purchased inventory for non-340B beneficiaries—may not dispense a 340B-purchased drug and
bill Medicaid the calculated Medicaid price for non-340B beneficiaries. For hemophilia drugs,
340B providers may submit the state upper limit established for a 340B purchased hemophilia
drug.
B.4 State Maximum Allowable Cost (SMAC) List
The state MAC list contains products with A-rated equivalents, and, in the great majority of
cases, products marketed by at least two labelers. The State’s MAC reimbursement is based on
the application of a percentage factor applied to the lowest priced generic. In cases where the
calculated MAC rate, based on the primary percentage factor, results in a price less than the
cost of the second lowest generic product, at least an additional 10 percent margin is added to
the cost of the second-lowest drug to establish the MAC price. The MAC pricing factor is set
by NC Medicaid and may change as deemed appropriate.
The additional margin is variable due to the wide range of differences in cost from product to
product. The SMAC list is posted on the NC Medicaid website, https://medicaid.ncdhhs.gov/.
For established generic drugs with only one supplier, the MAC price is established between the
actual acquisition cost and average wholesale price of the generic drug. A minimum
reimbursement of 20 percent above actual acquisition is guaranteed for these drugs. In most
cases, MAC pricing is substantially higher than this 20 percent, which allows the state and
pharmacies to share in the cost savings of using the generic product.
Drugs subjected to MAC pricing must be in adequate supply. Drug shortage information is
verified through national pharmacy websites as well as through information provided by
national drug wholesalers.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 37
Due to the many variations in the ingredients in prenatal vitamins and the corresponding
variation in the ingredient cost, a single MAC rate for prenatal vitamins is established and
maintained. Current marketplace acquisition cost, average wholesale price and wholesale
acquisition cost are evaluated to determine the single MAC rate.
B.5 Hemophilia Specialty Pharmacy Program
The General Assembly [Session Law 2012-142, Section 10.48(a2)] mandates that the N.C.
Medicaid Pharmacy programs establish a specialty pharmacy program for hemophilia drugs.
Refer to Clinical Coverage Policy No: 9B, Hemophilia Specialty Pharmacy Program, on NC
Medicaid’s website at https://medicaid.ncdhhs.gov/
.
B.6 National Drug Code (NDC)
The NDC is an arrangement of eleven (11) digits used to identify a drug product and package
size manufactured or distributed by a specific manufacturer. It is comprised of three “fields” of
data as follows:
Drug Code
Structure
AAAAA
BBBB
CC
Number of digits
in each field
5
4
2
The
Manufacturer
AAAAA
The Drug
Product
BBBB
The Package Size
CC
Leading zeros must be used for proper placement of numbers or letters in the NDC number
field of the pharmacy claim form or pharmacy software for electronic billing. Failure to record
all 11 digits in the proper position will result in a claim denial.
Such as: Inderal 20 mg Tablet 0046 422 81 must be spaced:
0 0 0 4 6 0 4 2 2 8 1
B.7 Drug Units
All quantities must be submitted in metric units. If the quantity is a decimal, then it must be
billed as such. Refer to Attachment G for the instructions and examples that apply to drug
units.
C. Billing Pharmacy Claims through Online, Real-Time Point of Sale
NC Medicaid mandates that all providers use the online, real-time POS system to process pharmacy
claims. Each pharmacy needs to work with their software vendor regarding online capabilities.
Claims are submitted through the “switching” companies.
The online POS system automatically performs eligibility verification, drug validation, pricing, and
edits and audits followed by Prospective Drug Utilization Review (Pro-DUR) before the pharmacy
dispenses a prescription. Immediate assurance of the amount to be paid for the prescription
reimbursement submitted through online claims is sent on the next check write. POS reduces
follow-up accounting for claims by allowing for the correction of any errors before the beneficiary
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 38
gets the prescription. Pharmacists receive all of the reject codes immediately when a claim is
submitted through POS; other submission methods are limited to returning the first reject
encountered.
The same policies for MAC overrides, co-pay exemption, and prescription limit overrides are in
effect for POS as for other claims processing media.
Refer to Attachment H for a summary of POS codes and other information for current claim
format.
C.1 Obtaining Point-of-Sale Software from a Vendor
Most software vendors are certified as capable of meeting the requirements to bill Medicaid
online. The billing pharmacy provider shall ensure that the software is capable of performing
the following functions:
a. Override rejects for DUR conflicts, when needed, by resubmitting the rejected claim with
DUR reason for service, professional service, and result of service codes.
b. Submit payments from other insurance plans for claims in an “Other Payer” field.
c. Override MAC prices with DAW 1 when proper documentation is provided by the
prescriber.
d. Override MAC prices with DAW 9 when NC Medicaid preferred Brand was dispensed
when generic equivalent is nonpreferred.
e. Send the NPI number as the prescriber identifier.
C.2 Online Point-of-Sale Processing Downtime
Monday 12:01a.m. – 4:00 a.m.
DHHS designated contractor’s
Provider Services unit is available from 8:00 a.m. through 5:00
p.m. weekdays to answer general pharmacy questions at 1-800-688-6696.
All communication/technical POS problems must be directed to your “switch vendor”
especially National Council for Prescription Drug Programs (NCPDP) reject codes 99 for
Host Processing Error.
C.3 Compound Prescription Claims on Point-of-Sale
All compound claims must be submitted at Point-of Sale. Compounds claims at point of sale
are limited to 25 ingredients.
C.4 Point-of-Sale Claims over $9,999
Claims over $9,999 require manual review for validity. POS claims are captured, but the
response is that there is no judgment on beneficiary eligibility or payment until the claim is
manually reviewed assurance that the claim has been accepted and reviewed. Please check your
RA or log into NC Tracks at www.nctracks.nc.gov to check the claim for payment.
C.5 Time Limit for Point-of-Sale Claims
POS claims must be billed within one year of the dispensing date.
C.6 Claims Processing for Selected DME Products
Claims for diabetic test strips, control solutions, lancets, lancing devices, and syringes
submitted at point-of-sale must be billed using the NDC. Test strips must be billed in multiples
of 50 or 51 and syringes and lancets must be billed in multiples of 100. For Medicaid billing, 1
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 39
lancing device equals 1 unit. Rates apply to these diabetic supplies; therefore, no copayments
and no dispensing fees apply. Diabetic supply limits are the same as under the DME Program.
Prior authorization requests for additional quantities or for non-preferred diabetic supplies must
go through the DME Program.
D. Provider Retroactive Pharmacy Claims Billing
When a provider accepts a private beneficiary and bills the private beneficiary personally for
services covered under Medicaid, and the beneficiary is later found to be retroactively
eligible for Medicaid, the provider may file for reimbursement with Medicaid. Upon receipt
of Medicaid reimbursement, the provider shall refund to the beneficiary all money paid by
the beneficiary for services covered by Medicaid, with the exception of any third-party
payments or cost-sharing amounts.
E. Billing Medicare before Medicaid
E.1 Full Dual Eligible Beneficiaries
When a Medicaid beneficiary has both Medicare and Medicaid coverage, pharmacy providers
are required to bill Medicare first for the limited number of pharmaceutical products covered
by that program. If the Medicare reimbursement does not equal 100 percent of the Medicare
allowable rate and not more than the Medicaid allowable rate, the pharmacy provider may
then bill Medicaid for the outstanding balance (coinsurance/deductible).
Due to restrictions imposed by Medicare on some drugs, such as restrictions to certain
diagnoses, an override is available whereby Medicaid can be billed for these drugs when not
covered by Medicare. For example, Imuran and methotrexate are only covered for the
diagnosis of cancer, so Medicaid would need to be billed for any other diagnosis. To override
the edit using POS, place a “1” (numeric) in the PA field.
A co-pay shall not be collected on any of the claims billed to Medicare. Once Medicare has
paid, bill Medicaid for the remaining amount. The system cannot deduct a co-pay for these
crossover claims.
The NC Medicaid Outpatient Pharmacy Program denies specific drugs that must be billed to
Medicare first for an identified beneficiary who is eligible for drug coverage under Medicare
Part B.
Medicaid may be billed for the unpaid portion of a claim paid by Medicare by entering the
following information in the appropriate fields:
1. the amount paid by Medicare in the Other Coverage Field;
2. the Medicaid reimbursement rate in the Amount Billed Field (dollars/cents).
Medicaid pays an amount equal to the Medicare allowable rate less the amount paid by
Medicare.
E.2 Qualified Medicare Beneficiaries (QMB)
QMB Medicaid beneficiaries have both Medicare and Medicaid coverage and pharmacy
providers are required to bill Medicare first for the limited number of pharmaceutical
products covered by that program. Medicaid pays the cost share on these medications.
For QMB claims, the pharmacy shall submit values in any of these three fields (353-NR,
351-NP, and 352-NQ) when applicable for the claim. These fields are used to identify the
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 40
beneficiary’s Medicare Coinsurance, Medicare Deductible, and Medicare Copayment
amounts.
F. Billing Remainder of a Third-Party Prescription to Medicaid
Medicaid is always the payor of last resort when a beneficiary has other insurance that covers
prescription drugs. If a beneficiary has other insurance, such as Medicare, which pays for
prescriptions, that insurance plan must be billed first. Medicaid may be billed for the unpaid portion
of a claim paid by another insurance company by entering the following information in the
appropriate fields on the claim:
1. The amount paid by the other insurance in Other Coverage Field
2. The Medicaid reimbursement rate in the Amount Billed field (dollars/cents)
3. Medicaid pays an amount equal to the Medicaid reimbursement rate less the co-payment, where
applicable, less the amount paid by the other insurance.
Medicaid reimbursement rate
• Amount paid by other insurance
• Medicaid co-payment according to Medicaid Drug and Eligibility files
Medicaid payment
The POS checks for current third-party coverage on the eligibility file. A message is sent back by
the POS system telling the provider that the beneficiary has third-party coverage for that date of
service. The other third party must be billed as the primary payor, and then Medicaid can be billed
as the second payor. In the event that the beneficiary cannot produce another insurance or the
beneficiary states they do not have other insurance, the pharmacy shall use a 01 – No Other
Coverage Identified in the Other Coverage Code, claim segment 308-C8 for NCPDP D.0
transactions. NC Medicaid pays the pharmacy and chases the third party for payment. The
pharmacy cannot be held liable for any payments made in these cases.
d. When a claim is denied for other coverage, the POS system will deny the claim and will be
indicated to submit to another payer.
• Override Codes for Cost Avoidance Process - Claim Segment defined as 308-C8 (Other
Coverage Code)
• Required/Optional/Not Used: Optional
• Field Type: N
• Max length: 2
• North Carolina Medicaid Specifications (override codes)
01= No Other Coverage Identified
02 = Other Coverage Exists - Payment Collected (The member has other coverage and the payor
has returned a payment amount. The payment amount is submitted in field 431-DV to the
secondary payor.
03 = Other Coverage Exists - This Claim Not Covered (Claim not covered under primary Third-
Party Plan. If primary denied the claim as Refill Too Soon, the claim would be submitted to the
secondary payor with the Other Coverage Code 3. In this situation, claim would more than likely be
too early for Medicaid as well)
NC Medicaid Medicaid
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24F27 41
04 = Other Coverage Exists - Payment Not Collected (Used when the member has other
coverage and that payor has accepted the claim but did not return any payment. This would be an
example in which the member had a deductible amount to meet under the primary payor. The
member is responsible for 100% of the payment, and the payor returns 100% of the payment, and
the payor returns $0.)
The override codes listed above will be reported back to Medicaid on a monthly basis.
Example: After third-party insurer has paid, the claim can be billed to Medicaid with the other
coverage amount indicated. For example, if a $100.00 claim is billed to PCS and they pay $65.00
(the beneficiary has a $20.00 co-pay), the claim is then submitted to Medicaid with $100.00 billed
amount and $65.00 in the other coverage field (431-DV).
The system will calculate the Medicaid allowable and then subtract $65.00 from that amount. There
should not be a reference to the $20.00 co-pay.
G. Billing for Nursing Home Prescriptions and IV Therapy
Due to special packaging or storage requirements for nursing home prescriptions and the stability
problems associated with IV therapy, a single prescription may have to be dispensed several times
during the month in small quantities. Because of the special circumstances involved in their
dispensing, prescriptions for nursing home beneficiaries and prescriptions for IV therapy may
be billed once per month. The monthly billed amount should reflect a total of all dispensing for
that one prescription for the month less any credit that might have occurred during the monthly
period.
H. Billing for Drugs Covered under Hospice
A beneficiary who is enrolled in the hospice program is covered under a per diem rate, which
covers all services related to the beneficiary’s terminal illness. The pharmacist is notified via the
POS system if a beneficiary is enrolled in hospice. All drug claims are denied with the message
“beneficiary claim covered by hospice.”
If the drug is to be used for an indication not directly related to the beneficiary’s terminal illness, an
override is available. A “1” entered in the PA field and the ICD-10-CM code for the beneficiary’s
terminal illness entered in the diagnosis field will override the hospice edit. Pharmacists shall not
use the ICD-10-CM code for the indication of the drug.
There are some drug classes where overrides are not allowed. For these drug classes, the claim
denies with Explanation of Benefits (EOB), “Recipient claim covered under Hospice”. These drug
classes include narcotic analgesics and narcotic analgesic combinations, hematinics, antiemetics,
most chemotherapeutics and antineoplastic aromatase inhibitors.
Questions concerning drug coverage for a hospice beneficiary are directed to the beneficiary’s
hospice agency.
Pharmacists shall contact NC Medicaid (919-855-4300) with questions regarding Medicaid or
coverage of pharmacy claims in the drug classes for which overrides are not allowed. If it is
determined that Medicaid coverage is appropriate, the provider is informed of billing instructions at
the time of the call.
NC Medicaid Medicaid
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24F27 42
I. Compounded Drugs
I.1 Billing for Compounded Drugs
If the compound prescription contains all legend products, then the claim for the compound can
be submitted by using POS (NCPDP D.0).
NCPDP D.0 (POS) Instructions
If the compound is billed using NCPDP D.0 (POS), the total ingredients billed must match the
compound ingredient component count. If they do not match, the claim denies. The cost for
each ingredient must be indicated and the dispensing fee should be included in the total billed
amount listed on the header. If NDCs are included in the compound that are not covered by
Medicaid the claim continues to process with the payable ingredients only. The POS system
assumes “8” in the submission clarification field, which means “PROCESS COMPOUND FOR
APPROVED INGREDIENTS.”
I.2 Reimbursement for Compound Drugs
Medicaid shall reimburse only for federal legend drugs contained in the compound that are
manufactured by companies who have signed a national Medicaid Drug Rebate Agreement
with CMS. If one prescription drug in the compound is not covered under the rebate agreement,
reimbursement is withheld for that drug only. The remainder of the compound is paid if
applicable. OTC products are also only reimbursed if the manufacturer has signed a national
Medicaid Drug Rebate Agreement with CMS and when contained in a compound with at least
one covered legend drug.
I.3 Summary of Compound Drug Reimbursement
Reimbursable compounds:
a. Mixture of two or more physically inseparable ingredients, with at least one legend
ingredient.
b. Only legend drugs from manufacturers who signed the Drug Rebate Agreement will be
reimbursed.
Non-reimbursable compounds:
EOB
Requirement not met
905
A compound without a legend-covered drug
905
A compound with only non-rebate drugs
038
OTC and DESI drugs as only ingredients
009
A compound equivalent to an OTC drug
009
OTC ingredients only
009
Two physically separable drugs (tablets and
capsules) in the same bottle
J. Point-of-Sale Reversals
Claims submitted using POS may be credited with a POS reversal for up to 12 consecutive months
after the dispense date. It is recommended that pharmacies submit reversals weekly or, at a
minimum, monthly. Pharmacies may obtain information on submitting a reversal, if needed, from
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 43
their pharmacy software vendor. DHHS fiscal contractor can reverse claims submitted using POS if
required.
POS reversals may be completed for claims submitted with incorrect quantities or NDCs. POS
reversals also allow the pharmacist to help beneficiaries who need additional medication when they
have already received the maximum number of prescriptions by permitting the reversal of a less
expensive prescription in order to allow billing of a more expensive prescription.
K. High Dosage Edit
The system checks for high dosage by comparing the units that are billed for the days supply limit
indicated with what has been approved by the FDA. If the units billed on the claim exceed this
limit, an edit notifies the provider that the units and days supply need to be verified for accuracy.
To override the edit and indicate that the units and days supply have been verified and are correct,
enter a “2” in the prior authorization field or in the submission clarification field.
L. Time Limit Overrides
NC Medicaid frequently receives requests to waive the federally prescribed 12-consecutive month
claims filing time limit. NC Medicaid has extremely limited authority to override the time limit
when eligibility was not approved within the year or for court decisions or hearings, which
authorize eligibility retroactively. Failure of the provider to file and follow up timely is not a basis
for override and results in denial of claims.
Medicaid claims, other than crossover and third party, must be received by DHHS fiscal contractor
within 365 calendar days from the date of service. Hospital inpatient, long-term care, and home
health claims must be received within 365 calendar days from the last date of service on the claim.
Medicare and Medicaid crossover and other third-party claims must be received within 180
calendar days from the date of payment or denial from the third-party payor or 365 calendar days
from the date of service, whichever is later. Proof that the claim was submitted timely includes:
4. correspondence about the claim received from NC Medicaid or DHHS fiscal contractor;
5. an explanation of Medicare or third-party benefits dated 180 calendar days from the date of
payment or denial;
6. a copy of the remittance and status report (RA) showing the claim pending or denied.
It is the provider’s responsibility to file claims in a timely manner and to follow up within the time
limit for claims not reported back on the RA. When claims are initially filed, providers should
allow approximately 30 calendar days for the transactions to appear on the RA. If there is no
indication on the RA that the claim was received, providers may use NC Tracks or the Automated
Voice Response System to determine the status of the claim. If the claim has not been received by
the DHHS fiscal contractor, providers should resubmit immediately to prevent denial for timely
filing.
M. Pharmacy Remittance Advice
The Remittance Advice (RA) is a computer-generated document showing the status of all claims
submitted to CSC along with a detailed breakdown of payment. The RA is produced at the same
time that checks are issued.
Refer to Attachment I for instructions for using the RA.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 44
N. Resubmission of Rejected or Denied Claims
N.1 Explanation of Benefit Codes
Rejected or denied claims are identified on the pharmacist’s RA with an explanation of
benefit (EOB) code, which explains why the claim was rejected or denied. The EOB assists
the pharmacist in correcting and resubmitting a rejected or denied claim.
N.2 Resubmitting a Claim
All claims must be submitted to CSC within 365 calendar days of the date of service. If a
claim is paid incorrectly or a claim is rejected or denied, providers have 18 consecutive
months from the date of the RA denial to resubmit a claim for processing.
Claims that are denied with no payment can be resubmitted as new claims. Claims that are
denied with no payment include
:
a. invalid date of service;
b. missing or invalid information such as quantity or billed amount;
c. NDC not on file.
Note: Claims that deny with this EOB message must be verified to ensure that the correct
NDC was listed on the original claim form.
Do not submit a new claim if a partial payment was received. If partial payment is
received on a claim, providers shall edit the claim and resubmit.
N.3 Name and Number Mismatch
To avoid a name and number mismatch, do not use the beneficiary’s middle initial on the
claim form. The beneficiary’s first and last name are sufficient. Enter the beneficiary’s MID
number and name as shown on the MID card or, if the beneficiary’s name has changed,
according to the eligibility file.
N.4 Eligibility Follow-Up
Because a beneficiary’s eligibility status may change from one (1) month to the next if the
financial or household circumstances change, providers shall verify the beneficiary’s
eligibility through a point-of-sale E1 transaction or through the Eligibility Verification
System for proof of eligibility each time a service is rendered. The most common EOBs
received for eligibility denials are these:
EOB Code
Message
011
Recipient not eligible on service date.
120
Recipient MID number missing
143
Recipient MID number not on State eligibility file
191
Recipient MID number does not match patient name
Refer to the following instructions to resolve a claim denied for eligibility.
Check for Errors on the Claim. Compare the beneficiary’s MID card to the information
entered via NCPDP. If the beneficiary’s name or MID number were not entered correctly on
the claim, complete corrections and resubmit. If they are correct, call the DHHS fiscal
contractor to verify eligibility.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 45
Attachment B: Table of Exemptions to Co-payment and Specific Edit
Override Information
Exemption
NCPDP
Condition
Co-pay
Beneficiary
Residence
PA Code
Submission
Clarification Field
Co-pay Exemption
Family Planning
Y
Drug File
Intermediate Care Facility/Mental
Retardation
Y
9
Skilled Nursing Facility
Y
2
Nursing Facility
Y
3
Pregnancy
Y
4 or
Eligibility
File
Exempt from co-pay only
Y
4
Health Check < 21 years old
Y
Eligibility
File
CAP
Y
Eligibility
File
Locations with No Automatic
Exemptions
Hospice
N
11
Rest Home
N
5
Specific Edit Overrides
Edit 907 (Dosage over FDA
guidelines)
N
2
Edit 946 (Medicare Edit)
N
1
Early Refill Override – Vacation
(in addition to DUR override)
N
3
Early Refill Override – Lost
prescription (in addition to DUR
override)
N
4
Early Refill Override – Change in
Therapy (in addition to DUR
override)
N
5
PDL Overrides – If “Meets PA
Criteria” is documented
N
1
2
.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 46
Attachment C: Requesting Prior Authorization for Prescription Drugs
The process to request authorization for the prescription drugs indicated in Subsections 5.1 and
5.2 is as follows:
a. The prescriber contacts the CSC clinical call center online at www.nctracks.nc.gov, by
telephone, or by fax. The prior authorization process is substantially quicker if done through
the web portal NCTracks and could be auto approved.
b. Hours of operation are Monday through Friday, 7:00 a.m. to 11:00 p.m. and Saturday through
Sunday, 7:00 a.m. to 6:00 p.m.
Phone: 1-866-246-8505
Fax: 1-866-246-8507
The prescriber offers information as specified on the prior authorization form for the drug
being requested. Copies of the forms are available online at http://nctracks.nc.gov. All
requests will be answered within 24 hours of receipt.
c. If the request for prior authorization is approved, CSC updates the system. The POS claims
processing system manages the PA information.
d. The billing pharmacy submits the claim for reimbursement. If the prescriber has not obtained
prior authorization, the POS will return a message of either PA REQ. PRESCRIBER CALL
CSC or CLAIM DENIED. PA LIMITS EXCEEDED. If the billing pharmacy receives one of
these messages, they may utilize the NCTracks web portal or CSC may be contacted at 1-
866-246-8505 to verify the status of the prior authorization request. Please notify the
prescriber to call CSC if a prior authorization has not been completed.
e. 72-Hour Emergency Supply
If the prior authorization request is approved, the emergency supply shall be billed through
POS as part of the original fill.
If the prior authorization request is not approved, the system will bypass the prior
authorization requirement if an emergency supply is indicated. A “3” in the Level of Service
field (418-DI) should be used to indicate that the transaction is an emergency fill. The claims
will only allow a 72-hour supply. Co-payments will apply. Edit 383 has also been developed
which will prevent the days supply edit 907 from being overridden for prior authorization
emergency fills. The new edit 383 indicates the following message to the provider: “CANT
USE OVERRIDE WITH A PA EMER FILL”.
f. Retroactive Prior Authorization
A prescriber or long term care pharmacist may request retroactive prior authorization (PA)
for medications in the pharmacy PA program for dates of service up to one year after
dispensing. (Note: Long term care pharmacists may not request prior authorization for Brand
Name Schedule II narcotics or sedative hypnotics.) Retroactive requests may be made by
contacting the CSC clinical call center and will be considered on a case-by-case basis. If no
other PA exists and the beneficiary meets criteria for full approval, a retroactive PA may be
entered to include backdates and forward for full approval period.
Additional information regarding the prior authorization process can be found at
www.nctracks.nc.gov
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 47
Attachment D: Narrow Therapeutic Index Drugs
(As published in the N.C. Register, Volume 23, Issue 17, March 2, 2009)
The following list of NTI drugs is reviewed on an annual basis and submitted to the Office of
Administrative Hearings by the N.C. Board of Pharmacy for publication in the N.C. Register.
• Carbamazepine: all oral dosage forms
• Cyclosporine: all oral dosage forms
• Digoxin: all oral dosage forms
• Ethosuximide
• Levothyroxine sodium tablets
• Lithium (including all salts): all oral dosage forms
• Phenytoin (including all salts): all oral dosage forms
• Procainamide
• Tacrolimus: all oral dosage forms
• Theophylline (including all salts): all oral dosage forms
• Warfarin sodium tablets
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 48
Attachment E: Drug Use Review Program
Overview of the Drug Use Review Program
In accordance with the Social Security Act of 1927 and the Omnibus Budget Reconciliation Act (OBRA)
of 1990, North Carolina established a Drug Use Review (DUR) program for outpatient drugs to assure
that the prescriptions dispensed to beneficiaries are:
a. Appropriate.
b. Medically necessary.
c. Not likely to result in adverse medical results
.
The program enhances the quality and appropriateness of beneficiary care by educating physicians and
pharmacists on common drug therapy problems to improve prescribing and dispensing practices. The
DUR program consists of the following components.
A. NC Medicaid
NC Medicaid will establish the Drug Use Review Board (DUR). The DUR Board will not have rule
making authority. NC Medicaid can reject the recommendations of the DUR Board by notifying the
Board in writing to allow the Board an opportunity to reconsider its decision. The criteria and
standards for the drug therapy review adopted by NC Medicaid upon recommendation by the DUR
Board shall be available to pharmacists, prescribers, and the general public.
B. DUR Board
The Board is composed of the NC Medicaid Use Review Coordinator, five licensed, actively
practicing physicians, five licensed, actively practicing pharmacists and at least two additional
individuals who have expertise in the clinically appropriate prescribing, dispensing, and monitoring
of covered outpatient drugs, drug use review, evaluation, and intervention or medical quality
assurance. One pharmacist and one physician shall act as co-chair on the Board. Co-chairs are
elected for a one year term by their peers and are eligible for a co-chair position after one year on
the Board. The term of membership shall be 12 months, with the option to renew for two additional
1-year periods.
The North Carolina Association of Pharmacists, the North Carolina Medical Society and the Old
North State Medical Society shall be asked to make nominations for some positions on the Board.
The Director will have the right to reject or accept nominations. The activities of the DUR Board
include establishing standards, retrospective DUR, and ongoing educational interventions. At least
quarterly, the drug claims, in conjunction with other medical claims as needed for clinical purposes,
shall be screened against the standards established by the DUR Board. The State assures it will
prepare an annual report to the Secretary, which incorporates a report from the State DUR Board,
and that the State will adhere to the plans, steps, and procedures as described in OBRA 90.
C. Prospective DUR
C.1 Purpose
The purpose of Prospective Drug Utilization Review (Pro-DUR) is to improve the quality
of care and promote cost savings by preventing adverse drug events before a prescription is
dispensed or used. Pro-DUR is an additional source of information for the pharmacist to use
in making decisions affecting pharmaceutical care.
NC Medicaid Medicaid
Outpatient Pharmacy Clinical Coverage Policy No: 9
Amended Date: July 15, 2024
24F27 49
A prospective review of drug therapy is conducted at the time a new prescription is filled.
This review involves comprehensive screening of the prescription. Potential drug therapy
problems based upon predetermined standards include, but are not limited to:
1. Therapeutic duplication.
2. Drug–disease contraindications.
3. Drug–drug interactions.
4. Drug interactions with nonprescription or over-the-counter drugs.
5. Drug–disease interactions.
6. Incorrect drug dosage or duration of therapy.
7. Drug allergy interactions.
8. Clinical abuse/misuse.
Pharmacies participating in Medicaid must conduct the Pro-DUR screening. To comply with
these standards, pharmacies must use either a prospective DUR software database or written
standards consistent with the DUR Board policy. Additional Pro-DUR screening is provided
for claims submitted using POS.
The National Council of Prescription Drug Programs (NCPDP) Pro-DUR alerts the
dispensing pharmacist of potential conflicts. This requires a professional service or
result of service coding before payment is made for the prescription. If the
pharmacist determines that the prescription shall be dispensed, the pharmacist must
document their professional judgment by responding to the DUR alert. If more than
one DUR alert is received, it is only necessary for the pharmacist to respond to the
first alert. All of the criteria required to respond to the DUR alert is contained in the
DUR information sent with the alert. A DUR conflict must be documented with
NCPDP DUR result of service and professional service codes in order to receive
payment for a resubmitted prescription.
C.2 Procedure for Responding to DUR Al