CMS Program Audit Universes and Protocol Changes Tabled Until 2022

The Centers for Medicare and Medicaid Services (CMS) recently released the 2021 Program Audit Memo, which announced that it will start sending engagement letters in March of 2021, and will continue to do so through July of 2021. CMS also announced that it will continue to use the 2020 protocols for program audits in 2021. CMS initially intended to use the updated protocols in 2021, but is still waiting for approval from the Office of Management and Budget (OMB).

CMS has stated: “Delaying implementation of the updated protocols proposed under CMS-10717 will give stakeholders sufficient lead-time to apply and test the updated protocols prior to CMS using them to conduct audits.”

Health plans should use the time to ensure that they and their Pharmacy Benefit Manager (PBM) have reviewed the updated protocols anticipated for 2022 to ensure compliance with data extraction and population. Of note is one of the new universes, “Universe Table 7: Comprehensive Addiction and Recovery Act (CARA) At Risk Determination (AR) Record Layout”. Plans should verify whether they are aligned with their PBM to define the responsible party and confirm that the layout has been reviewed and is ready for use in 2022.

CMS’s 2019 Part C and Part D Program Audit and Enforcement Report did not include the common conditions cited during program audits, as it has done in years past. This exclusion is unfortunate in that it is typically a helpful learning tool for plans to modify oversight activities and incorporate noted best practices into their operations. That being said, with the goal of ensuring member access to entitled benefits and focusing on noncompliance related to access to care, GHG would expect CMS’s areas of focus to include COVID-19 flexibilities and proper administration of opioids edits in Formulary Administration. 

In the 2020 Part C Organization Determinations, Appeals, and Grievances (ODAG) protocol, CMS eliminated the Call Log universe (Table 14). In the Compliance Program Effectiveness (CPE) protocol, CMS suspended the CPE self-assessment questionnaire and made several changes to the CPE universes.

As we head into the 2021 CMS Program Audit season, take the appropriate steps to ensure that your health plan has updated its universe data pulls accordingly.

Where Do We Go from Here?

With all the stressors on health plans in the current environment and the ever-changing landscape of the COVID-19 pandemic, the news from CMS to continue use of the 2020 audit protocols may come as a bit of a relief. However, plans must not be complacent about audit preparation and should remain diligent about their PBM oversight activities. Plans are still encouraged to perform mocks audit to plan, evaluate their operations and practice the experience.

Gorman Health Group (GHG) assists plans in implementing process improvements in relation to new CMS requirements. Our team of subject matter experts also conduct readiness assessments and mock program audits to validate adherence and identify potential areas of risk or concern. Contact us today to start the conversation.

Caron Wingerchuk
Caron Wingerchuk

Caron Wingerchuk is a Senior Director of Pharmacy Solutions at Convey Health Solutions (Convey). In this role, she has participated in audit remediation, Pharmacy Benefit Management (PBM) delegation oversight and monitoring, Part D benefit testing, and best practice implementation. Caron brings Convey clients more than 20 years of healthcare experience in clinical program development and strategy, Pharmacy and Therapeutics (P&T) Committees and Part D pharmacy operational compliance.

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