As the CY2024 audit season wraps up, the Centers for Medicare and Medicaid Services (CMS) has been publishing both draft and final reports for those selected for program audits. We are seeing a mix of enduring issues and some fresh concerns in the Part D audit areas.
Formulary Administration (FA) Highlights:
- Insulin and Glucagon-like peptide-1 (GLP1) Agonists: CMS has expanded their scrutiny to include more cases involving insulin products and GLP1s. CMS is particularly focused on the appropriateness of rejections. Auditors are reviewing historical claims, paid claim outcomes (including $35 out-of-pocket costs for covered insulins), and any coverage determinations on file.
- Enrollment and Eligibility: CMS increased emphasis on enrollment and eligibility rejections, with CMS delving into MARx data to ensure that claims adjudication considers member-specific information.
- Medically Accepted Indication (MAI): Audits have scrutinized the use of ICD-10 codes to confirm that medications are used for their medically accepted indications during claim adjudication or coverage determination reviews.
Long-standing issues also persist in the areas of transitions, prior authorizations, and protected class drugs:
- Transition Benefits: Auditors found failures in setting up new beneficiaries for transition benefits and in providing transition fills when a medication is used for an MAI.
- Prior Authorizations: Issues include prior authorizations that are more restrictive than CMS formularies, or those that are improperly broad or narrow, leading to inappropriate medication inclusion or exclusion.
- Protected Class Drugs: Inappropriate rejections involving prior authorizations (PA) or step therapy (ST) restrictions for new beneficiaries (PA/ST Type 2) were noted.
Coverage Determinations, Appeals, and Grievances (CDAG) Trends:
- Misclassification: There were instances of redeterminations misclassified as coverage determinations, often due to the increased use of electronic prior authorizations following an initial denial.
- GLP1s: CMS was particularly attentive to the appropriateness of diagnoses in both approved and denied cases involving GLP1s that have cardiac indications, like Wegovy™.
- Case Review Consistency: This season saw a focus on the consistency of case reviewers. CMS verified that decisions at the CD level (pharmacist for denials) and RD level involved the appropriate individuals, including Medical Directors when the CD was denied for lack of medical necessity.
- New Start Utilization: There was an uptick in new start prior authorization cases. CMS focused on confirming that members were new to therapy with no prior claims or authorizations for the medication.
Longstanding findings continue to surface:
- Request Classification: Misclassifying coverage determinations/redeterminations as grievances remains a recurring issue.
- Clinical Rationale and Notifications: CMS continues to emphasize full clinical reviews, including outreach attempts, and the appropriateness of dismissal reasons and appeal language.
- Coordination of Requests: Part B versus Part D cases were frequently reviewed. CMS ensured that for MAPD plans, if a Part D denial occurred, enrollees could access the Part B review process without the need for resubmission.
By prioritizing thorough oversight, performing consistent monitoring activities, and adopting best practices observed in program audits, sponsors can ensure they remain compliant and continue to deliver high-quality care to their beneficiaries.
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