Pharmacy (Centennial Care) — Coverage Criteria and HCV Treatment Guidance
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Defines Centennial Care pharmacy benefit rules and Managed Care Organization (MCO) obligations for formulary management, prior authorization, Hepatitis C treatment guidance, community pharmacy reimbursement, DUR participation, drug rebate dispute resolution, and PBM oversight. Applies to MCOs administering New Mexico Centennial Care pharmacy services.
No material clinical or coverage changes in this revision.
Coverage and Formulary Rules
Hepatitis C treatment — approval
MCOs are to approve properly requested treatments for chronic HCV infection when ALL of the following are met:
MCOs may prefer a formulary agent if level of evidence and effectiveness (SVR) is equal or greater and no drug interactions are of concern.
Hepatitis C treatment — procedural
Additional procedural requirements for HCV requests:
MCOs must not use active alcohol or drug use screening criteria or the specialty of the requesting provider as screening criteria for treatment, approval, or denial.
MCOs must maintain a distinct formulary or Preferred Drug List (PDL) for Centennial Care that includes all multi-source generic drug items, with specific allowable exclusions. The PDL may exclude cosmetic items, fertility drugs, anti-obesity drugs, items not medically necessary, and cough/cold/allergy medications. Inclusion of a multisource generic on the PDL does not prevent the MCO from requiring prior authorization for that item.
The formulary must cover at least the same level of services as the base benchmark pharmacy benefit, ensuring at least one drug in every category and class (or the same number of drugs as the benchmark, whichever is greater). The formulary must also include brand-name drugs when necessary, including sole-source brands, but a prescriber may always request a non-formulary or non-PDL drug item via prior authorization; such requests are subject to MCO medical necessity review and appeal processes.
Items that are not medically necessary are explicitly listed as allowable exclusions from the PDL requirement for multi-source generics and may be denied coverage following MCO medical necessity review. When a prescriber seeks a non-formulary or non-PDL drug, the prescriber must submit a prior authorization request and the MCO must evaluate the request for medical necessity; denials are subject to member appeal and administrative hearing.
For drugs requiring prior authorization, MCOs must accept the Uniform Drug Authorization Request Form (MAD 635) as the required submission mechanism. The policy also requires an open formulary for all psychotropic drugs and medications, and does not remove the prescriber’s ability to request exceptions to the PDL through the prior authorization process.
Initial Hepatitis C Therapy Criteria
HCV initial therapy
Initial HCV therapy coverage conditions:
MCO may prefer a formulary agent if evidence and effectiveness (SVR) are equal or greater and no drug interactions are of concern.
Provider Requirements, Prior Authorization, and Documentation
Prior authorization — use MAD 635 and prescriber rights
MCOs must accept the Uniform Drug Authorization Request Form (MAD 635) for drugs requiring prior authorization. Prescribers retain the ability to request non‑formulary or non‑PDL items via prior authorization, including certification of 'Brand Medically Necessary' which precludes generic step therapy when properly submitted. The MCO must evaluate such requests for medical necessity and a denial is subject to member appeal up to an HSD administrative hearing.
- Use MAD 635 (Uniform Drug Authorization Request Form) for PA submissions.
- Submit non‑formulary or non‑PDL requests via prior authorization for MCO medical necessity review.
- When prescriber certifies 'Brand Medically Necessary' for a brand drug, do not require generic fail‑first prior to dispensing the brand.
Step therapy exception for prescriber‑certified brand
If the prescriber certifies 'Brand Medically Necessary' on the prescription, the MCO must not require demonstration of fail‑first or step therapy on the generic before dispensing the brand product.
- Prescriber certification of 'Brand Medically Necessary' removes any prior authorization requirement to fail on the generic equivalent.
HCV checklist and required supporting documentation (MAD 634)
For HCV treatment requests, the Uniform New Mexico HCV Checklist (MAD 634) must be fully completed and submitted with required laboratory data and copies of relevant medical records. Documentation should include genotype, Hepatitis C RNA (viral load), fibrosis/cirrhosis assessment, prior treatment history, and resistance‑associated substitutions (RAS) testing if required by AASLD guidance.
- Attach completed MAD 634 checklist with the request.
- Include genotype and Hepatitis C RNA (viral load) results.
- Provide fibrosis/cirrhosis assessment (APRI, Fib‑4, transient elastography, Fibrotest, imaging, or biopsy) per guidance.
- Attach prior HCV treatment history and RAS testing when required.
Retain MAC selection records and provide dispute documentation
Retain and provide documentation used to select Maximum Allowable Cost (MAC) prices when requested for drug rebate dispute resolution. MCOs must, on request, provide provider purchase invoices or other proof of purchase and explain how the MAC price was established.
- Keep records showing how MAC prices were determined (basis of the price, effective date, any NDC used).
- Provide provider purchase invoices or proof of purchase to HSD's PBM and manufacturers upon request.
Denial risk for non‑formulary/non‑PDL prior authorization requests
A prior authorization request for a non‑formulary or non‑PDL drug may be denied after the MCO evaluates medical necessity; such denials are subject to member appeal and possible HSD administrative hearing.
- Prescribers must submit PA requests for non‑formulary/non‑PDL items so the MCO can perform a medical necessity review.
- Be prepared to support the medical necessity rationale in the submission to reduce denial risk.
HCV treatment denial triggers — guideline and documentation requirements
HCV treatment requests that are not consistent with AASLD/IDSA guidance or that are not submitted with a fully completed MAD 634 checklist and required labs/records may be denied; off‑guideline requests require peer‑to‑peer consultation and presentation to Project ECHO before denial.
- Ensure treatment regimen (drug, dose, duration) aligns with AASLD/IDSA guidance; if not, expect MCO to offer an appropriate alternative.
- Complete MAD 634 fully and attach required labs/records to avoid denial.
- If requesting off‑guideline treatment, be prepared for peer‑to‑peer consultation and Project ECHO review prior to any denial.
Coding, Tests, and Diagnostic Thresholds
| 42 C.F.R. § 438.3(s) | Regulatory reference for DUR program compliance |
| 42 C.F.R. Part 456 Subpart K | Regulatory reference for DUR requirements |
| Section 1927(g) of the Social Security Act | Medicaid statutory requirement for DUR |
Clinical Definitions
Step Therapy and Brand Medically Necessary Rules
| Requirement | Notes |
|---|---|
| Prescriber-certified 'Brand Medically Necessary' | When the prescriber certifies 'Brand Medically Necessary', prior authorization is not required to dispense the brand-name drug instead of a generic, and neither a demonstration of fail-first nor step therapy on the generic will be required prior to dispensing the brand. |
| Effect on step therapy/fail-first | No step therapy or fail‑first requirement applies when 'Brand Medically Necessary' is certified by the prescriber; the brand may be dispensed without requiring trial of the generic. |
Background and Purpose
This policy provides treatment guidance to ensure timely access to oral direct-acting antiviral therapy for chronic Hepatitis C (HCV) for members aged 17 years and older with active infection. Coverage decisions must align with AASLD/IDSA guidance for regimen selection (genotype, dose, duration) and consider prior treatment history and resistance-associated substitution (RAS) testing when required.
MCOs must require documentation of infection and disease stage: a positive HCV RNA and assessment of fibrosis/cirrhosis using accepted criteria. Cirrhosis may be considered present with APRI >= 1.01, Fib-4 >= 3.252, Transient Elastography >= 12.5 kPa, or Fibrotest >= 0.73, or by compatible radiographic/physical findings or liver biopsy (METAVIR F4).
Procedurally, requests must include the fully completed Uniform New Mexico HCV Checklist (MAD 634) with required labs and medical records attached. MCOs should refer members to community health workers, care coordinators, or specialty pharmacists at the time of drug treatment request and must report quarterly data on HCV requests and outcomes by fibrosis stage and genotype. Off-guideline requests should be presented to Project ECHO and a peer-to-peer consultation initiated prior to denial.
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