PAAS National® analysts continue to see audits requesting documentation of compliance policies and procedures. FWA Training and OIG/GSA exclusion checks are not enough to be compliant as they do not constitute a compliance program. Since 2009, PAAS’ Fraud, Waste & Abuse and HIPAA Compliance program has been designed to meet CMS’ seven core elements required to adopt and implement an effective compliance program, which include:
- Written Policies, Procedures and Standards of Conduct
- Compliance Officer, Compliance Committee and High-Level Oversight
- Effective Training and Education
- Effective Lines of Communication
- Well Publicized Disciplinary Standards
- Effective System for Routine Monitoring and Identification of Compliance Risk
- Procedures and System for Prompt Response to Compliance Issues
PBM Provider Agreements require pharmacies to have a compliance program that meets CMS standards, and they reserve the right to request documentation of your compliance policies and procedures.
Consider the following:
- OptumRx Section VIII Compliance; Fraud, Waste and Abuse (FWA); General Training; Audits – “A Network Pharmacy Provider involved in providing services for Medicare Part D/Medicaid Members is responsible for implementing a program to control FWA and to facilitate compliance in the delivery of Covered Prescription Services through the Medicare/Medicaid benefits.”
- Humana’s 2022 Notice of Program Requirements – Humana’s Compliance Policy for Contracted Healthcare Providers explicitly states pharmacies must have a compliance program that meets the seven elements outlined by CMS, including written policies, procedures and standards of conduct.
- PerformRx Pharmacy Compliance Attestation 2022/2023 – PerformRx requires attestations to the following: The pharmacy has implemented and maintains a compliance program that is consistent, at minimum, with applicable federal and state requirements, including, but not limited to the standards set forth in 42 CFR §423.504(b)(4)(vi) and other Centers for Medicare & Medicaid Services (CMS) guidance set forth in the Medicare Part D Prescription Drug Benefit Manual.
- While not public, Express Scripts and Caremark also have explicit language to require a compliance program. See Caremark’s 2022 Provider Manual, Section 10.01.06 FWA program and Express Scripts 2022 Provider Manual with regards to maintaining a compliance program in accordance with CMS requirements.
Ensure you have all your compliance bases met so you can provide proof when requested for credentialing or audit. Don’t have an FWA/HIPAA Compliance Program? Contact PAAS, firstname.lastname@example.org or (608) 873-1342 and get started today!