CurrentAlabama MedicaidPolicy 560-X-16-.31
Hemophilia Management Standards and Pharmaceutical Services Reimbursement
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Governs Alabama Medicaid coverage, reimbursement, provider participation, and pharmacy-related rules for prescription drugs and services for Medicaid beneficiaries in Alabama.
Policy Summary
PayerAlabama Medicaid
PolicyHemophilia Management Standards and Pharmaceutical Services Reimbursement (Chapter 16)
Policy CodePolicy 560-X-16-.31
Change TypeRoutine review — no material change
Effective DateMar 16, 2024
Last ReviewMar 16, 2024
Next Review DateN/A
Key ActionPharmacies and hemophilia providers must ensure emergency delivery of blood clotting factor within 24 hours (target <12) and maintain monthly case representative contact documentation.
SourceLink
POLICY UPDATE CHANGES
No material clinical or coverage changes in this revision.
$10.64dispensing fee
ASP + 6%blood clotting reimbursement
3 monthsmax maintenance supply
4 brand / 5 totalmonthly Rx limit
+/-10%assay variance
Coverage and Reimbursement Rules
Coverage criteria and reimbursement rules
General coverage rules, exclusions, reimbursement limits, and special-entity pricing.
Only drugs manufactured by companies with signed federal rebate agreements are compensable, except enumerated exclusions (DESI/IRS restrictions; agents for anorexia/weight alteration except specified; fertility agents except specified; symptomatic cough/cold agents; most prescription vitamins/minerals except prenatal and fluoride and others specified by the Agency; selective non-prescription drugs as listed on the Medicaid website; drugs requiring manufacturer-mandated tests/services).
Medicaid will pay for properly prescribed drug items when prescribed by authorized practitioners and dispensed/administered in accordance with state and federal law.
Reimbursement for most outpatient drugs shall not exceed the lowest of: (a) Alabama Average Acquisition Cost (AAC) (effective Jan 1, 2021) or when no AAC available WAC-based fallback plus a professional dispensing fee of $10.64; (b) dispensing fee of $10.64; or (c) general public price; Federal Upper Limit (FUL) and Usual & Customary may apply as noted.
Blood clotting factor products are reimbursed at Average Sales Price (ASP) + 6% plus the professional dispensing fee; physician-administered drugs (PADs) are reimbursed at ASP + 6% (or published compendia/WAC when ASP unavailable); PADs administered by 340B entities reimbursed at the entity's actual acquisition cost plus dispensing fee.
Eligible 340B entities listed on HRSA 340B database and entities purchasing through FSS or at Nominal Price are reimbursed at actual acquisition cost plus the professional dispensing fee of $10.64.
Investigational drugs not approved by the FDA are not covered.
Pharmacists shall submit claims in the units specified on the prescription for up to a 34-day supply; a three-month supply is permitted for certain maintenance therapies after at least 60 days of documented stability; quantities >34 days may be recouped unless appropriate documentation is provided; dosage forms that prevent exact 30–34 day dispensing (e.g., insulin) may exceed 34 days with documentation.
Only one dispensing fee is allowed per 30–34 day supply of the same drug per month unless the designated amount of the original days' supply has been utilized or there is documented consultation with the prescribing physician; designated-amount thresholds: ≤34-day supply — 85% for opioids and 75% for other drugs; >34-day supply — 90%.
Medicaid may reimburse licensed pharmacists for professional services (e.g., vaccine administration, medication therapy/adherence services) as designated by the Agency.
Physicians may dispense only when eligible under the rules (e.g., areas lacking adequate pharmacy services as defined) and providers must meet participation requirements including appropriate state permits/licenses, signing the pharmacy agreement, maintaining records, and permitting audits; out-of-state record retrieval costs borne by provider when records located out of state.
Written outpatient prescriptions must be executed on tamper-resistant pads when required; telephone prescriptions for Schedule II are not permitted except specific long-term care/facsimile exceptions; pharmacists must retain original prescription documentation per program rules.
Key coverage and billing criteria
Key coverage and billing criteria and operational rules affecting dispensing, refills, limits, copay, and overrides.
Only one dispensing fee is allowed for a 30–34 day supply of the same drug per month unless the designated amount is used or there is documented consultation with the prescribing physician; designated amount thresholds: ≤34-day supply — 85% for opioids and 75% for other drugs; >34-day supply — 90%.
Pharmacist professional services may be reimbursed when provided by licensed pharmacists (examples include vaccine administration and medication maintenance/adherence services as designated by the Agency).
Copayment is required for each prescription and refill except for family planning drugs/supplies, recipients under 18, nursing facility residents, and pregnant women; copay amount is based on drug ingredient cost per the schedule from Medicaid; providers may not deny services for inability to pay the copay.
Quantity and refill limits: a prescription shall not be split into multiple claims to obtain additional dispensing fees; maximum refills — 11 for non-controlled prescriptions and 5 for CIII–V; claims beyond these limits will be denied. Pharmacist must contact and document prescriber authorization to reduce quantity and must note reductions on the prescription. If partial fills occur, units dispensed must be noted and claim retained until balance dispensed; only one dispensing fee paid for split fills within same month unless documentation justifies multiple fees.
Maintenance medications: recipients may obtain a three-month supply after demonstrating 60 days of stability on same strength and dose; only one copay and one dispensing fee collected for the three-month supply; Agency provides list of maintenance medications online.
Monthly prescription limits (effective Oct 1, 2013): general limit is four brand-name and five total drugs per month per recipient; total prescriptions may not exceed ten per month; exclusions include recipients under 21 (EPSDT) and nursing facility residents; certain therapeutic classes may be eligible for overrides to allow up to ten prescriptions when physician documents medical necessity for brand switch within same class and first product was Medicaid-covered.
Out-of-state pharmacy policy: out-of-state pharmacies must complete application and sign Pharmacy Vendor Agreement; pharmacies within 30 miles of Alabama border require certification by that state's Board of Pharmacy; non-border pharmacies may be enrolled temporarily with restrictions and must provide specialty drug names and identifiers when requesting enrollment.
Injectables administered by physicians or outpatient facilities must be submitted on the appropriate claim forms; the Medicaid Pharmacy Program reviews and approves injectable medications and reimbursement rates.
Overrides: coverage beyond standard monthly limits and allowance for up to ten brand-name prescriptions per month for specified AHFS therapeutic classes may be granted only when the prescribing physician documents medical necessity; pharmacist must contact prescriber to authorize quantity reductions and document authorizations on the prescription.
PDL and Prior Authorization Criteria
Preferred Drug List usage and the conditions under which prior authorization (PA) is required and processed.
Use of the Preferred Drug List (PDL) is mandatory for reimbursement; prescriptions within the scope of the PDL that are not on the list require prior authorization before being reimbursed.
The Pharmacy & Therapeutics Committee reviews and recommends drugs for PDL and PA placement; decisions for PA are based on clinical review including DUR/SUR data, potential abuse/misuse, inconsistency with FDA labeling or authoritative compendia, and other clinical considerations; clinical bases and recommendations will be documented and available upon written request.
Medicaid may require PA for generic products only when cost of the generic is significantly greater than the net cost of another product in the same AHFS therapeutic class or when there are safety/abuse concerns; Medicaid will document the reasons for PA of a generic product.
Medicaid will develop public medical criteria for coverage authorization; PA requests must be initiated by the practitioner and will be reviewed by Medicaid or its designated agent; responses should be issued within eight hours but not more than 24 hours; emergency provisions permit dispensing a 72-hour supply when needed.
Program exceptions: Gold Standard Program may exempt selected high PDL-compliant providers from PA for certain drugs when specific prescription-based criteria are met; eligibility and exclusions determined by Medicaid.
DUR Program Requirements
Drug Utilization Review (DUR) program components, required prospective screening, counseling, retrospective review, and educational interventions.
Prospective DUR (PRODUR) is required at the point of sale/distribution prior to each fill and must include screening, patient counseling, and patient profiles; PRODUR screening is the pharmacy's responsibility.
PRODUR screening must include checks for therapeutic duplication, drug/disease contraindications, drug interactions, incorrect dosage or duration, drug allergy interactions, and clinical abuse/misuse, using predetermined standards based on peer-reviewed literature and referenced compendia.
Patient counseling must be offered for new prescriptions and where appropriate for refills; counseling may be offered in writing, by telephone, or by other appropriate means; pharmacies must maintain recipient counseling logs and patient profiles containing at minimum name, age, gender, address, phone, medication history, and pharmacist comments.
Retrospective DUR involves periodic claims-data review to identify fraud, abuse, overuse, or medically unnecessary care; cases of possible fraud/abuse may be referred to the Medicaid Program Integrity Division.
An educational program applies DUR criteria after dispensing and may include dissemination of information, written/oral/electronic reminders, face-to-face discussions, and intensified monitoring or interventions for selected prescribers or dispensers.
Hemophilia Management Standards
Minimum standards of care and operational requirements for providers dispensing blood clotting factor and related services to Medicaid recipients.
Providers must perform home or office delivery of blood clotting factor and supplies with appropriate cold-chain management and packaging to preserve stability, integrity, and efficacy during shipment (including overnight deliveries when applicable).
Providers must develop and maintain a training library at each enrolled location and provide educational materials to patients/family/caregivers at initiation, annually during in-home assessment, and upon request; education topics must include injury/bleed prevention, self-administration, and product reconstitution.
Providers must supply medically necessary ancillary supplies for IV administration (billable through DME), provide sharps containers and compliant disposal/pickup, and maintain emergency 24/7 telephone support for patients.
Assign a pharmacist, nurse, and/or case representative to each patient; the case representative must document at minimum monthly telephone contact covering patient well-being, adherence, adverse events, supply/inventory, and confirmation of next delivery; clinical staff must meet hemophilia-specific continuing education requirements (pharmacists minimum 2 CE hours/year; nurses and social workers minimum 4 CEU hours/year).
Compliance program requirements: assess patient adherence monthly and during in-home visits, verify and document on-hand factor prior to each dispense (no automatic shipments), track bleeds and infusions from prior shipments to validate need or non-compliance, and discourage stockpiling.
Emergency delivery standard: providers must deliver blood clotting factor for emergent situations within 24 hours (target less than 12 hours) of receipt of a prescription or notification for a patient with an existing valid prescription; patient education should emphasize maintaining adequate supply and self-administration skills.
Recall and withdrawal procedures: promptly quarantine recalled stock, retrieve and quarantine dispensed recalled items with patient notification within 24 hours, notify prescribing physician, and obtain an alternative prescription if necessary.
Visiting clinical services: initial and annual in-home assessments by a nurse or pharmacist trained in hemophilia are required, with additional visits as clinically indicated; providers must continue services until an alternative provider is arranged when discontinuing services and coordinate transitions per Agency guidance.
Assay-to-prescription management: a registered pharmacist trained in blood clotting factor-related diseases shall manage assay-to-prescription variance; providers should aim for the lowest assay percentage and must not exceed +/- 10% variance from target dose; dispensing extra vials within the +/-10% variance may be subject to recoupment; therapy changes for cost reasons require prescriber written approval documented in the patient chart.
Codes, Limits, and Refill Rules
claim submission identifiersmixed
| NPI or state license | Use correct NPI provider ID or state license number in prescriber ID field when submitting a pharmacy claim |
Drug identifiers for enrollmentNDC | mixed
| GCN / NDC | Specialty drug identifiers required when non-border pharmacies request enrollment |
mixed
Assay-to-prescription variancemixedCovered
| No codes listed |
inv-11: designated amount thresholds for early refill
Designated amount for ≤34-day supply (opioids)85% of the original days' supply
Designated amount for ≤34-day supply (non-opioids)75% of the original days' supply
Designated amount for >34-day supply90% of the original days' supply
inv-12: Monthly prescription limits
Standard monthly limit (brand/total)4 brand name and 5 total drugs per month per recipient
Absolute monthly maximumNo more than 10 total prescriptions per month per recipient
Exceptions allowing up to 10 brand name drugsCertain therapeutic classes (AHFS/FDB) may be allowed up to 10 brand name prescriptions via physician-documented medical necessity override
inv-13: Refill limits
Maximum refills — non-controlledUp to 11 refills
Maximum refills — Controlled III-VUp to 5 refills
Refill documentation requirementsIf physician grants oral authorization to refill a non-refillable prescription, pharmacist must note each authorization on the prescription
inv-14: Minimum market time before manufacturer review
Minimum market time before manufacturer review6 months
PDL review process referenceDrugs considered for PDL based on clinical efficacy, side effects, and appropriate usage prior to review
Reconsideration timelineManufacturers may request reconsideration within 30 calendar days after posting of final PDL
inv-15: Manufacturer submission deadline for written comments
Manufacturer submission deadline for written commentsOne-page summary and materials must be submitted 21 calendar days prior to the Pharmacy & Therapeutics Committee meeting
Oral presentation limitsOral presentations limited to 5 minutes per drug class and one representative per product
Copies for distributionManufacturers must provide 20 copies by the deadline if summary distributed to Committee members
inv-16: Assay variance limit
Permitted assay-to-prescription variancePlus or minus 10% (+/−10%)
Dispensing guidance within varianceProviders should attempt to achieve the lowest assay percentage and dispense as close to prescribed target dose as possible without opening an extra vial
Financial recoupment riskExtra vials dispensed within the +/-10% assay variance may be subject to recoupment
Provider Requirements, Authorization, and Operations
Documentation Required
Prescription origination and claim submission rules
Original prescriptions must be retained by the pharmacy for state and audit purposes; claims may be submitted electronically only if the provider has signed an electronic claim agreement with Alabama Medicaid. Telephone prescriptions are not allowed for Schedule II controlled substances except that for long-term care facility residents a Schedule II prescription may be transmitted by facsimile and the facsimile shall serve as the original written prescription. Written outpatient prescriptions not on a tamper‑resistant blank must be resubmitted in compliant form or converted to an allowable verbal, faxed, or electronic prescription; in emergency situations a noncompliant form may be filled but a compliant prescription must be obtained within 72 hours or the claim must be withdrawn. Pharmacies must use the correct NPI or state license number in the prescriber ID field when submitting a claim.
- Retain the original part of the Medicaid Pharmacy Claim for state and audit purposes; submit duplicate to fiscal agent or submit electronically if an electronic claim agreement is on file. [[cited]]
- Do not accept telephone prescriptions for Schedule II; LTC facsimile exception: facsimile serves as original written prescription for LTC residents. [[cited]]
- If a written prescription is not on a tamper‑resistant pad, obtain compliant resubmission or convert to allowable format; if emergency fill, obtain compliant prescription within 72 hours or withdraw claim. [[cited]]
- Use the correct NPI or state license number in the prescriber ID field when filing pharmacy claims. [[cited]]
- Submit claims in the units specified on the prescription up to a 34‑day supply (three‑month supply permitted for designated maintenance therapies with prior stability documentation). [[cited]]
Prior Authorization
Overrides for hard denials and early refill requirements
Hard denials for early refill, therapeutic duplication, or excessive quantity require an override from Medicaid or its designated agent before payment will be made. For early refills, pharmacists must document that the prescribing physician was consulted and approved the refill on the original prescription; payments for early refills may be recouped if documentation is not provided.
- Obtain an override from Medicaid or its designated agent for hard denials (early refill, therapeutic duplication, excessive quantity) before expecting payment. [[cited]]
- Document physician consultation and approval on the original prescription for any early refill; be aware Medicaid may recoup payment for unauthorized early refills. [[cited]]
- Note any changes to the original prescription (including physician‑approved dosage changes) on the original prescription. [[cited]]
Documentation Required
Out-of-State Pharmacy Enrollment
Out‑of‑state pharmacies must complete an application and sign a Pharmacy Vendor Agreement with Alabama Medicaid. Pharmacies bordering Alabama (within 30 miles) must be certified by their state Board of Pharmacy; non‑border pharmacies may be enrolled temporarily and must list specialty drug names and GCN or NDC numbers when requesting enrollment.
- Complete the out‑of‑state pharmacy application and sign the Alabama Medicaid Pharmacy Vendor Agreement. [[cited]]
- If the pharmacy borders Alabama (≤30 miles), obtain certification from that state's Board of Pharmacy before participation. [[cited]]
- Non‑border pharmacies (more than 30 miles) will be enrolled temporarily and must include names and GCN or NDC numbers of specialty drugs intended for reimbursement. Reimbursement for non‑border pharmacies is limited to hemophilia products, specialty drugs not readily available in‑state, and drugs for recipients traveling outside Alabama. [[cited]]
Prior Authorization
Overrides and Pharmacist Authorization
Pharmacists must contact the prescribing physician to authorize reduction of quantity and must note that authorization on the prescription. Overrides to exceed standard monthly prescription limits may be granted when the prescribing physician documents medical necessity, for example to switch to a required brand within a therapeutic class; pharmacist‑initiated quantity changes must be documented.
- Contact the prescriber to authorize any reduction in units and document the authorization on the original prescription. [[cited]]
- When requesting overrides to the monthly limits (e.g., four brand / five total drugs per month, up to ten in specified classes), ensure the prescribing physician documents medical necessity for the override (such as a brand switch within a therapeutic class) as required. [[cited]]
- Retain documentation for split fills: note units dispensed and retain claim until balance dispensed; submit a single dispensing fee for split fills unless documentation justifies multiple fees. [[cited]]
Prior Authorization
Prior Authorization requirements and timelines
Prior authorization (PA) may be required per Pharmacy & Therapeutics Committee recommendations and is based on clinical review (DUR/SUR data, abuse/misuse concerns, labeling or compendia inconsistencies). PA requests must be initiated by the practitioner; Medicaid or its designated agent will review requests and respond within eight hours but no more than 24 hours. In emergencies, a 72‑hour supply may be dispensed.
- Initiate PA requests through the practitioner when medically necessary; the practitioner must start the request. [[cited]]
- Medicaid or its designated agent will review PA requests against developed medical criteria; responses should be issued within 8 hours but no more than 24 hours after receipt. [[cited]]
- If PA is denied, the prescribing physician may submit adequate medical justification in writing for reconsideration. [[cited]]
- In emergency situations, pharmacies may dispense a 72‑hour supply of a covered outpatient prescription drug pending PA. [[cited]]
Billing Rule
PDL and PA interaction
Use of the Preferred Drug List (PDL) is mandatory for Medicaid reimbursement; prescriptions for drugs within the PDL scope that are not on the list require prior authorization before being reimbursed.
- Check the Alabama Medicaid PDL before dispensing; if the prescribed drug is within the PDL scope but not listed, obtain prior authorization before reimbursement will be allowed. [[cited]]
- Be aware that Medicaid may designate a drug subject to PA as preferred via manufacturer agreement where permitted by federal law. [[cited]]
Step Therapy
Gold Standard PA exemption program
Providers meeting Gold Standard Program criteria may receive exemptions from prior authorization for certain drugs when specific prescription‑based criteria are met; Alabama Medicaid determines which providers qualify and maintains the program.
- Maintain high PDL compliance to be considered for the Gold Standard Program; Alabama Medicaid will determine eligibility and monitor maintenance of criteria. [[cited]]
- Even with Gold Standard status, certain exclusions apply and the exemption only applies when the specified prescription‑based criteria are met. [[cited]]
Note
Emergency delivery and care coordination
For hemophilia emergencies, providers must deliver blood clotting factor within 24 hours of receipt of a prescription (target under 12 hours) and assign a pharmacist, nurse, and/or case representative to each patient with documented monthly telephone contact covering adherence, adverse events, inventory, and next delivery. Case representatives must document monthly contact and providers must emphasize patient maintenance of an adequate supply.
- Provide emergency delivery of blood clotting factor within 24 hours (target <12) of receipt of a prescription or notification for emergent situations. [[cited]]
- Assign a pharmacist, nurse, and/or case representative to each patient; the case representative must document at minimum monthly telephone contact addressing well‑being, adherence, adverse events, inventory, and next delivery. [[cited]]
- During patient education emphasize keeping an adequate supply on hand and training in self‑administration for emergencies. [[cited]]
Key Definitions and Terms
inv-25: Covered outpatient drugs definition and exclusions
Definition — Covered outpatient drugsDrugs compensable by Medicaid when manufactured by companies with signed federal rebate agreements
Key exclusions — DESI/IRS drugsDESI and IRS drugs which may be restricted per Section 1927(d)(2) of the Social Security Act
Key exclusions — anorexia and fertility agentsAgents for anorexia/weight or fertility are excluded except those specified by the Alabama Medicaid Agency
Key exclusions — cough/cold and most OTC vitaminsAgents for symptomatic relief of cough and cold and most OTC vitamin/mineral products are excluded except specified exceptions (e.g., prenatal vitamins, fluoride)
inv-26: AAC and ASP pricing definitions
AAC definition and useAlabama Average Acquisition Cost (AAC) is used for reimbursement effective January 1, 2021; when no AAC available, WAC-based fallback rates are used
ASP use for clotting factors and PADsBlood clotting factor products and Physician Administered Drugs (PADs) reimbursed at Average Sales Price (ASP) + 6%
340B entity pricingEligible 340B entities are reimbursed at the entity's actual acquisition cost plus the professional dispensing fee
inv-27: Maintenance medications definition (3-month supply after stability)
Definition — Maintenance medicationsMedications used to treat chronic conditions, ordered/prescribed and taken regularly and continuously
Three-month supply eligibilityRecipients may obtain a three month supply after demonstrating stability for at least 60 days on the same strength and dose
Fees for three-month supplyOnly one co-pay and one dispensing fee are charged/paid for the three month supply
inv-28: Pharmacies bordering Alabama definition
Definition — Pharmacies bordering AlabamaPharmacies located not more than 30 miles from the border of Alabama
Participation requirementsMust complete out-of-state application, be certified by that state's Board of Pharmacy, and sign a Pharmacy Vendor Agreement
Non-border pharmacies treatmentPharmacies >30 miles may be enrolled temporarily with reimbursement limited to hemophilia products, specialty drugs not readily available in-state, and drugs for recipients traveling outside Alabama
inv-29: Therapeutic duplication definition
Definition — Therapeutic duplicationPrescribing/dispensing overlapping administration of two or more doses of the same drug, two drugs from same therapeutic class, or two drugs from different classes with similar pharmacologic effects for the same indication when not medically indicated
PRODUR screening roleTherapeutic duplication is a required screen in Prospective DUR at point of sale
Action on duplicationPharmacist must respond to PRODUR alerts and may need to consult patient or prescriber if essential information is missing
inv-30: PRODUR definition and requirements
Definition — PRODURProspective DUR (PRODUR) is required at point of sale or distribution before each prescription is filled and includes screening, patient counseling, and patient profiles
Required screening elementsIncludes checks for therapeutic duplication, drug/disease contraindications, interactions, incorrect dosage/duration, allergy interactions, and clinical abuse/misuse
Pharmacy responsibilityPRODUR screening is the sole responsibility of each Medicaid participating pharmacy and a requirement for participation
inv-31: Hemophilia-specific CE requirements for pharmacists, nurses, social workers
Pharmacist CE requirementMinimum of 2 hemophilia-specific Continuing Education credit hours per year
Nurse and social worker CE requirementMinimum of 4 hemophilia-specific Continuing Education (CEU) hours per year
Accreditation requirementContinuing education must be specific to hemophilia and recognized by a state or national health care professional accrediting body
inv-32: Case representative definition
Definition — Case representativeIndividual (may be administrative support) assigned to each patient who must maintain and document at minimum monthly telephone contact covering well-being, adherence, adverse events, inventory, and next delivery
Coordination with clinical staffCase representatives must coordinate with clinical staff (pharmacist, nurse) if clinical issues arise
Documentation frequencyMonthly telephone contact must be documented and include specified assessments (adherence, bleeds, inventory)
inv-33: Assay-to-prescription variance definition
Assay-to-prescription variance definitionPermitted deviation between assay and target dose expressed as plus or minus 10% (+/−10%)
Dispensing goal within varianceProviders should attempt to achieve the lowest assay percentage and dispense as close to the prescribed target dose as possible without opening an extra vial
Recoupment cautionExtra vials dispensed within the +/-10% assay variance may be subject to recoupment
Policy Summary
PayerAlabama Medicaid
PolicyHemophilia Management Standards and Pharmaceutical Services Reimbursement (Chapter 16)
Policy CodePolicy 560-X-16-.31
Change TypeRoutine review — no material change
Effective DateMar 16, 2024
Last ReviewMar 16, 2024
Next Review DateN/A
Key ActionPharmacies and hemophilia providers must ensure emergency delivery of blood clotting factor within 24 hours (target <12) and maintain monthly case representative contact documentation.
SourceLink
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