CMS Announces Audits Targeting Fraud, Waste, and Abuse Beginning October 2022

Beginning October 2022 and continuing throughout 2023, CMS, in conjunction with the Plan Program Integrity Medicare Drug Integrity Contract (PPI MEDIC), will initiate three National Audits, six Self-Audits and four Program Integrity (PI) Audits. These audits are being conducted to evaluate plan sponsors’ efforts to detect, prevent, and correct fraud waste and abuse (FWA).

• • National Audits
    • CMS will use prescription drug event (PDE) data to conduct National Audits. National Audits will focus on drugs that are often used for indications that are not supported by CMS-approved compendia. The first set of drugs CMS will target, and their common Part D covered uses, are listed below:
      • Transmucosal Immediate Release Fentanyl (TIRF) drugs like Actiq, Fentora, Lazanda, Onsolis, Subsys, and fentanyl citrate sublingual tables – breakthrough pain in adults with cancer who are routinely taking other opioid pain medications around-the-clock
      • Targretin – FDA-approved for prior cutaneous T-cell lymphoma, refractory to prior therapies. Targretin also has compendia support for psoriasis and AIDS-related Kaposi’s sarcoma
      • Adcirca – pulmonary arterial hypertension (PAH)
      • Revatio – pulmonary arterial hypertension (PAH)
      • Cialis – benign prostatic hyperplasia
• Self-Audits
  • Self-Audits will be focused on claims that crossover between Medicare Part C and Medicare Part D to ensure that the PDEs for these claims were correctly paid under Part D. CMS plans to target drugs provided to enrollees who have elected hospice. Although CMS has not released a specific list of drugs that will be targeted, BluePeak expects a focus on analgesics, antinauseants, laxatives and anti-anxiety prescription drugs. It is important to note that the scope of self-audits can be expanded at CMS’ discretion.

• Program Integrity Audits
  • Finally, PI audits evaluate the plan sponsor’s efforts to address PI risks. Although CMS does not identify specific oversight and monitoring activities, plan sponsors are required to have effective processes in place to detect, prevent, and correct FWA, as outlined in CMS regulations. CMS plans to target FWA complaints, FWA referrals, FWA requests for information, Center for Program Integrity (CPI) audits, and Health Plan Management Systems (HPMS) memos.

• Next Steps for FWA Audit Readiness
  • So, what can plans do to prepare for these audits?
    • Review PDEs for drugs targeted in the National Audits and Self-Audits to ensure appropriate utilization and coverage
    • Ensure that your coverage determination and redetermination oversight and monitoring activities include a targeted review of the drugs included in these audits
    • Work with your pharmacy benefit manager (PBM) to ensure that appropriate controls are in place to prevent inappropriate utilization and coverage of drugs targeted in these audits
    • Ensure that a hospice payment recovery and PDE exclude process for claims identified as having paid inappropriately under the Part D benefit is in place and documented
    • Ensure that FWA policies and procedures are up to date
    • Ensure there are procedures in place to address FWA complaints, referrals, and requests for information, as well as FWA-related HPMS memos

The first audit will initiate in October 2022 with a national review of TIRF drugs. Plan sponsors should continue to monitor HPMS for additional information as well as potential selection for the audits.