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All the new in the CMS ’22 ODAG Protocol

by Yvonne Tso, Senior Vice President of Pharmacy, Pharm.D., MBA




The Centers for Medicare & Medicaid Services (CMS) launched a new cycle of program audits in February 2022. We are currently about six weeks from the end of the 2022 cycle[1], so there is still time to review the new and changed features of the CY 2022 audit protocol. For Organization Determinations, Appeals and Grievances (ODAG), here is what to look for during an audit, best practices for ODAG, and some of Integritas’ recent experiences with CMS audits[2].


1. Universe tables have been streamlined from thirteen to six

The audit elements to be tested remain the same – timeliness, processing and classification of coverage requests. However, Table 6 (Dual Special Needs Plan – Applicable Integrated Plan (AIP) Reductions, Suspensions, and Terminations (AIP)) is required if the plan sponsor is determined to be an applicable integrated plan[3] and has been notified by CMS of this status. Part B drugs is a new data field in Table 1 (Standard and Expedited Pre-Service Requests for Organization Determinations (OD)).


2. What to look for during an audit

CMS selects 60 targeted samples for the ODAG audit to ensure enrollees have appropriate access to health care services and medications and to verify that plan sponsors are adhering to selected aspects of their contracts with CMS. The compliance standards and methods of evaluation are outlined in the protocol. ODAG audits evaluate, among other things, whether plan sponsors have adequate processes to make appropriate clinical decisions based on National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs) or internal coverage policies[4]. In our experience, several areas represent the most common risks for plan sponsors in an ODAG audit.


Inappropriate denial of plan-directed care, not requiring or obtaining a waiver of liability (WOL) from non-contract providers (NCPs) and not including appeal rights in denial notices to NCPs, enrollees may incur inappropriate out-of-pocket expenses for medical services.


Best Practices: Train the Claims Department staff to spot plan-directed care when denying payments to NCPs. A description of the need for the WOL and appeal rights should be included the denial notice to NCPs. Regular monitoring of claims and denial notifications can mitigate this risk.


Charging enrollees incorrect cost-sharing due to failure to update their systems with a correct fee schedule. This causes claims to providers to be paid incorrectly which results in enrollees being overcharged for their coinsurance or delayed refund of overpayments.


Best Practices: Downloading and updating fee schedules for medical services for in-network and out-of-network critical access hospital claims should be systematically programmed because manual updates are time-consuming and prone to errors. Fee schedule changes are increasingly frequent[5]. Plan sponsors should have an established procedure to avoid outdated fee schedules.


Inappropriate adjudication or determination for Part B drugs due to lack of coordination or oversight. In 2019, some plan sponsors began applying step therapy for Part B drugs which are covered under ODAG and Part C benefits[6]. The lookback for Part B therapy is 365 days[7] and the turnaround time is aligned with those for Part D (24 hours for expedited requests and 72 hours for standard).


Best Practices: Sponsors should document the ODAG process for Part B drugs which typically falls under the Utilization Management department. Some Part B drugs, however, are adjudicated by Pharmacy Benefits Managers (PBMs) as they are often dispensed by a community pharmacy. Copayments for pharmacy dispensed Part B drugs should be cumulatively tracked with copayments for other Part B services so that enrollees do not pay more than their Maximum Out of Pocket (MOOP). Ensuring compliance with the Medicare rules requires regular monitoring or mock audits of claims and delegated entities, including the PBM, and timely corrective action to avert non-compliance. When performing internal monitoring, plan sponsors should practice the submission of the comprehensive universe data from delegated entities and ensure their accuracy to prepare for a future audit and to ensure compliance with CMS requirements.


Timeliness continues to be a common finding in ODAG audits due to inadequate system support or lack of training. For Dual Eligible Special Needs Plans – Applicable Integrated Plans (DSNP-AIPs), written notice of the denial must be provided within 3 days of receipt of the request. The additional 3-day allowance to deliver the written notification after providing oral notice does not apply. An extension of 14 days is allowed only if it is in the interest of the enrollee. The extension is not permissible for Part B therapy.


Best Practices: A plan sponsor’s tracking system for ODAG should include the notification date and time for tracking timeliness for all enrollee demographics, not just the date and time of the decision. The turnaround time for Part B drugs is applicable if the Part B drug is the primary request[8]. Plan sponsors should practice extracting universe data on an ongoing basis including quality review of output. They can send questions arising from routine practice to CMS or seek data clarification from the CMS auditors during the data integrity testing webinar.


Incorrect categorization of grievances when it was a coverage request, due to inadequate training of intake staff.


Best Practices: Regularly monitor and train intake staff and review of call logs and grievance responses, whether verbally or in writing, so that enrollees do not experience delays in access to covered benefits and every complaint is addressed in the response. We continue to see this as a vulnerability for plan sponsors in ODAG.


The success of an audit starts with the plan sponsor’s ability to submit accurate universes and supplemental documentation for review. Financial soundness and running a plan operationally with proper resources are equally important in audit preparedness. Plan sponsors may consider retaining consultants such as Integritas to support their data extraction practice or to conduct mock audits. Integritas has a team of deeply experienced Medicare Advantage and Part D specialists to assist plan sponsors with all aspects of the CMS audit process.


If you would like an in-depth discussion to learn from our audit experiences and how to meet challenges from evolving changes in Medicare compliance rules, visit our website www.IntegritasMedicare.com or call us at 1.415.596.5277.

[1] Routine audit notification ends in July 2022 but Sponsors may still be notified of audits under special circumstances [2] Integritas has subject matter experts that support sponsors in their CMS program audits and conduct Independent Validation audits. [3] As defined by 42 CFR § 422.561 [4] Plan sponsors should rely on guidance in the order the order of NCDs, LCDs and internal policies, which could be based on clinical guidelines from commercial sources. [5] For both Part A and B services, Medicare can change fee schedules retroactively and send addenda for updates. [6] CMS announced the change in policy in an August 7, 2018 memo. [7] To determine if step therapy rules apply [8] CMS 4180-F and ODAG 508 protocol

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