Physician-Administered Drugs Prior Authorization
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Defines prior authorization criteria and process for coverage of physician- or clinician-administered drugs and biologics for AllCare Advantage members; applies to drugs given by a healthcare professional in outpatient clinical settings.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial prior authorization decision algorithm
Covered when the sequential approval criteria are satisfied according to the algorithm below
Flow proceeds stepwise; approvals occur at decision points when criteria are met (see policy algorithm).
Renewal criteria
Renewal evaluation
Efficacy documentation required for renewal.
The policy applies to physician‑administered drugs and biologics (non‑vaccine) given by a medical professional in an outpatient clinical setting and requires that use be reasonable and medically necessary according to accepted standards of medical practice. Medications administered for purposes other than treatment of a specific condition, illness, or injury are not covered. Likewise, parenteral (injection) administration is not covered when standard medical practice indicates that an effective and accepted oral alternative exists. Treatments that exceed accepted frequency or duration for injections are also excluded.
Use is considered not medically necessary when injections are provided for non‑treatment purposes (for example, when the drug is not intended to treat a diagnosed condition), when an oral route is effective and is the accepted or preferred method of administration, or when the proposed frequency or duration of injectable therapy exceeds accepted standards of practice. Requests that meet any of these conditions should be denied as not medically necessary.
Initial Therapy Criteria
Initial therapy
Initial authorization expectations
Follow the stepwise algorithm in policy (see Initial prior authorization decision algorithm).
Continuation / Renewal Criteria
Renewal / continuation
Criteria for continued coverage
Continuation contingent on documentation of efficacy and prior criteria being met.
Provider Actions & Prior Authorization Process
Prior authorization must follow the stepwise review algorithm
Prior authorization is required and follows a stepwise review: confirm the request includes a valid drug code; determine whether an applicable CCO drug policy applies (refer to that policy if present); assess for a preferred lower-cost alternative and require medical rationale if bypassing it; attach applicable OHP or MCG guideline when available and evaluate the request against those guidelines; if no guideline applies, determine whether use is reasonable and necessary considering FDA indication; if not, evaluate off‑label use against major compendia for medical acceptance and safety.
- Step 1: Valid drug code required; requests with invalid codes are not approved.
- Step 2: If a CCO drug policy exists for the agent, refer to that policy.
- Steps 3–4: Redirect to preferred lower-cost agent when available; require medical rationale to bypass.
- Steps 5–7: Attach and follow applicable OHP or MCG guidelines when present.
- Steps 8–9: If no guideline applies, evaluate FDA indication or off-label use per major compendia.
Redirect to preferred lower-cost agent unless medical rationale provided
When a preferred lower-cost alternative exists, the request should be redirected to that preferred agent unless the provider submits a medical rationale explaining why the preferred agent cannot be used.
- If provider does not provide medical rationale to bypass the preferred agent, the PA is denied per the decision algorithm.
Required documentation for PA and renewals
Providers must submit the valid drug code for the requested agent and attach applicable guideline documents; if requesting a non‑preferred agent, include medical rationale explaining why the preferred agent cannot be used. For renewals, submit documentation demonstrating treatment efficacy.
- Include valid drug code on the PA request.
- Attach applicable OHP or MCG guideline when available.
- Provide clinical rationale when bypassing a preferred agent.
- For renewals, provide documentation of treatment efficacy to qualify for approval up to 12 months.
Denial triggers when algorithm requirements are unmet
Denials occur when required elements of the algorithm are not met: do not approve requests with an invalid drug code, and deny PA when a preferred lower‑cost alternative exists but the provider fails to submit medical rationale to justify use of a non‑preferred agent; deny when the request does not meet applicable guidelines or accepted off‑label compendia.
- Invalid drug code → do not approve.
- No medical rationale to bypass preferred agent → deny PA.
- Request fails to meet applicable OHP/MCG guideline or accepted off‑label compendia → deny PA.
Step Therapy / Preferred Agent Redirection
| Step | Question / action | Resulting action |
|---|---|---|
| {"text":"1","status":""}|{"text":"Is the request for a valid drug code?","status":""}|{"text":"If yes, proceed to step 2; if no, do not approve — clarify requested agent.","status":"not_covered"} | ||
| {"text":"2","status":""}|{"text":"Is there an applicable CCO drug policy that addresses the requested agent?","status":""}|{"text":"If yes, refer to that specific drug policy for coverage criteria; if no, proceed to step 3.","status":""} | ||
| {"text":"3","status":""}|{"text":"Is there a preferred lower-cost alternative that could be used in place of the requested agent?","status":""}|{"text":"If yes, redirect to the preferred agent and proceed to step 4; if no, proceed to step 5.","status":""} | ||
| {"text":"4","status":""}|{"text":"Did the provider submit medical rationale supporting that the member cannot use the preferred agent?","status":""}|{"text":"If yes, proceed to step 5; if no, deny prior authorization.","status":"not_covered"} | ||
| {"text":"5","status":""}|{"text":"Is there an applicable OHP guideline that addresses the requested agent?","status":""}|{"text":"If yes, attach the guideline and proceed to step 7; if no, proceed to step 6.","status":""} | ||
| {"text":"6","status":""}|{"text":"Is there an applicable MCG guideline that addresses the requested agent?","status":""}|{"text":"If yes, attach the guideline and proceed to step 7; if no, proceed to step 8.","status":""} | ||
| {"text":"7","status":""}|{"text":"Does the request meet the applicable guideline(s) for coverage of the requested agent?","status":""}|{"text":"If yes, approve; if no, deny prior authorization.","status":""} | ||
| {"text":"8","status":""}|{"text":"Is use of the agent reasonable and necessary for the individual patient considering FDA‑approved indication?","status":""}|{"text":"If yes, approve; if no, evaluate off‑label use for medical acceptance per major compendia and safety — approve if accepted, otherwise deny prior authorization.","status":""} |
Site of Care
Office‑administered drugs: applicable site of care
This policy applies to physician‑administered drugs and biologics that are typically given by a medical professional in a physician's office or other outpatient clinical setting (excluding vaccines).
- Site of care: administration in office or outpatient clinical setting by a healthcare professional.
Definitions
Background
Physician‑administered drugs and biologics are medications (excluding vaccines) typically given by a healthcare professional in a physician’s office or other outpatient setting. Coverage requires that the medication be reasonable and medically necessary for diagnosis or effective treatment of a specific illness or injury per accepted standards of medical practice. The policy emphasizes that therapeutic injections should be reserved for situations where equally effective oral medications cannot be used without significant or increased side effects.
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