Prior authorization requires documentation of initial PAH criteria and specialist involvement

Prior authorization will only be approved when documentation shows the member meets the policy's initial PAH approval criteria, including that the medication is prescribed by or in consultation with a cardiologist or pulmonologist.

• Approval requires evidence the member meets all initial PAH criteria.
• Specialist prescriber or documented consultation (cardiologist or pulmonologist) must be included.

Document trial and failure of a calcium channel blocker (see Appendix B)

For initial approval, the provider must document a trial and failure (or intolerance/contraindication) of a calcium channel blocker per Appendix B unless the member has an inadequate response to acute vasodilator testing or a contraindication/intolerance to CCBs.

• See Appendix B for listed agents and dosing (e.g., nifedipine, diltiazem, amlodipine).
• Exceptions: inadequate response to acute vasodilator testing or contraindication/clinically significant adverse effects to CCBs.

Historical reorganization and duration increases

Policy appendices and criteria were reorganized historically, and the documented initial and continuation approval durations were increased (initial to 6 months and continuation to 12 months).

• Appendices covering PH groups, functional class, and therapies were reorganized.
• Initial duration increased to 6 months; continuation duration increased to 12 months per policy history.

Submit office notes, labs, or other clinical information to support approval

Providers must submit supporting clinical documentation (for example, office chart notes, laboratory results, or other clinical information) that verifies the member has met all approval criteria.

• Include documentation that demonstrates diagnosis of PAH and fulfillment of initial criteria (specialist consult, CCB trial status, dosing).

Policy guidance — use as a medical necessity guide; follow evidence of coverage

This clinical policy is intended as a guide to medical necessity; coverage decisions remain subject to the member's evidence of coverage and applicable state/federal requirements.

• The policy does not guarantee payment and does not replace professional medical judgment.
• Coverage is subject to terms, conditions, exclusions, and limitations of the member's contract and applicable laws.

Lack of required documentation or unsupported off‑label requests may be denied

Failure to provide documentation that the member meets the approval criteria—or requests for non‑FDA (off‑label) indications without sufficient off‑label supporting documentation—may result in denial of the request.

• Non‑FDA indications require sufficient documentation per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage.
• Missing clinical records, labs, or notes that demonstrate criteria are met can trigger a denial.

Safety criteria removed except for contraindications/black box warnings not covered by REMS

Safety-related criteria were removed from the policy unless they represent true contraindications or black box warnings not covered by a REMS program; such contraindications and REMS-exempt black box warnings remain actionable.

• Contraindications and black box warnings not covered by REMS remain relevant for coverage decisions.
• Other previously listed safety parameters were removed unless they required specific lab/imaging parameters before initiation.

Prior authorization history and review notes (no specific PA codes listed here)

Policy history documents reviews, revisions, and approvals (including dates and notes) related to prior authorization processes; the chunks cited do not list specific PA code requirements.

• Multiple review entries note additions (e.g., Alyq added, max quantity per day) and annual reviews with dates.
• No specific prior authorization coding requirements are present in these cited chunks.