ModifiedBlue Cross Blue Shield - North CarolinaPolicy N/A

MAC A Penalty Criteria

Defines clinical and documentation criteria under which Blue Cross NC may waive additional fees to allow dispensing a brand-name medication when an A‑rated generic is available, including required prescriber and patient conditions and required submission of an FDA MedWatch form. Also specifies approval duration and review cadence.

Policy Summary

PayerBlue Cross Blue Shield - North Carolina

PolicyMAC A Penalty Criteria

Policy CodePolicy N/A

Change TypeCriteria revised; approval duration extended

Effective Date

Next Review Date

Key ActionPrescriber must indicate 'Dispense As Written (DAW)', document trial of an A-rated generic and the specific adverse event (excipient allergy or life‑threatening side effect), and complete and submit the FDA MedWatch form with a copy for authorization.

SourceLink

POLICY UPDATE CHANGES

Updated requirement to trial an A-rated generic equivalent.

Updated duration of approval to 3 years (1095 days).

Reformatted criteria and updated duration of approval to 1 year.

4Required criteria elements

1095Approval duration (days)

Coverage Summary

Overview: Blue Cross NC covers with criteria (waiver may be granted) when all specified clinical and documentation conditions are met for dispensing a brand-name medication despite an available generic. Key requirement includes the prescriber marking the prescription Dispense As Written (DAW), evidence of trial of an A-rated generic equivalent, documentation of either an excipient allergy or a life‑threatening side effect to the generic, and completion/submission of the FDA MedWatch Adverse Event Reporting Form with a copy provided. Duration of approval: 1095 days (3 years). Last review: 2026-04.

Medical-Necessity Criteria — Waiver Conditions

Criteria for waiving additional brand-name medication fees when a generic is available

Waiver may be granted when ALL of the following are met:

ALL of the following

The prescriber has indicated on the prescription 'Dispense As Written (DAW)'.
The patient has tried an A-rated generic equivalent to the brand name medication.
ONE of
- The patient had a documented allergic reaction to an excipient (inactive ingredient) that is present in the generic formulation but is absent in the brand name equivalent.
- The patient had a documented life-threatening side effect that required medical intervention to a generic medication that did not occur with the brand.
The prescriber completed and submitted an FDA MedWatch Adverse Event Reporting Form and provided a copy of the completed MedWatch form; authorization will not be considered unless the form is completed and submitted to the FDA.

Provider Actions & Documentation Requirements

Prior Authorization

Request waiver of additional brand-name fees

Prescriber must request a waiver by indicating Dispense As Written (DAW) on the prescription, documenting a trial of an A-rated generic equivalent, documenting either an excipient allergy present in the generic (but absent in the brand) or a life‑threatening side effect to the generic that required medical intervention, and completing/submitting an FDA MedWatch Adverse Event Reporting Form (provide a copy).

Write DAW on the prescription.
Document trial of an A-rated generic equivalent.
Document either an excipient allergy to the generic (absent in brand) or a life‑threatening side effect to the generic that required medical intervention.
Complete and submit the FDA MedWatch Adverse Event Reporting Form and provide a copy with the authorization request.

Documentation Required

MedWatch form submission required

Authorization will not be considered unless the prescriber completes and submits the FDA MedWatch Adverse Event Reporting Form and provides a copy of the completed form as part of the request.

Complete the FDA MedWatch Adverse Event Reporting Form (healthcare professional version).
Submit the completed MedWatch form to the FDA and include a copy with the authorization request.

Operational thresholds and timing

Duration of Approval1095 days (3 years)

Review cadenceReviewed annually by the Blue Cross NC P&T Committee; policy reviewed in Q4 annually

Last review date2026-04

Definitions & Evidence

Background: Blue Cross NC may waive additional fees to dispense a brand-name medication when a generic is available if specific clinical and documentation conditions are met. The policy is reviewed annually by the Blue Cross NC P&T Committee (policy reviewed in Q4 each year). The prescriber must complete and submit an FDA MedWatch Adverse Event Reporting Form as part of the authorization; authorization will not be considered without the completed MedWatch form.

Term	Definition
{"text":"A-rated generic equivalent","status":""}{"text":"Generic drug rated by FDA as therapeutically equivalent to the brand-name product.","status":""}
{"text":"Dispense As Written (DAW)","status":""}{"text":"Prescriber instruction on the prescription to dispense the brand-name product as written without substitution.","status":""}
{"text":"MedWatch Adverse Event Reporting Form","status":""}{"text":"FDA form for reporting adverse events; must be completed by prescriber and submitted to FDA with copy provided for authorization.","status":""}

Evidence: The criteria reference FDA source materials — specifically the FDA package insert for product information and the FDA MedWatch resources for adverse event reporting (MedWatch program info and the MedWatch form for healthcare professionals).

Revision History

April 2026criteria_revisedLatest

Updated requirement to trial an A-rated generic equivalent; updated duration of approval to 3 years (1095 days).

March 2024criteria_revised