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Key Updates in Medicare Parts C & D Appeals, Grievances, and Determinations Guidance

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The Centers for Medicare & Medicaid Services (CMS) updated the Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance on November 18, 2024. These updates aim to streamline processes and clarify responsibilities for enrollees, representatives, and providers.

Expanded Grievance Requirements: What’s New?

CMS has added Grievances to the requirement for coverage determinations and appeals. For instance:

The Grievance process is available only to the enrollees and their representatives. Providers should file complaints with plans in accordance with the applicable plans’ dispute resolution processes; and, if after communicating with the plans’ dispute resolution is unsatisfactory, may contact their local CMS’ regional office.

MA plans and Part D plans are not required to process grievances when the person or entity making the grievance is not permitted [1]by 42 CFR §§ 422.564 or 423.564. In circumstances where necessary representative documentation is missing, and not received by the end of the grievance processing period, the plan should notify the enrollee and the purported representative that the plan is unable to process the grievance. This notice should include instructions on how the enrollee, or a valid representative, may resubmit the grievance.

A plan may, but is not required to, accept and process a grievance that is filed after the 60-day deadline or submitted with missing or defective representative documentation.  If the plan chooses not to accept the invalid filing, the plan should notify the enrollee of the plan’s decision to not accept the grievance.

Coverage Determinations and Notifications: Key Changes

  1. Plans are not required to process quality-of-care grievances from representatives who fail to provide timely documentation but may investigate at their discretion without notifying the enrollee of the outcome, since the grievance was not properly filed.
  2. Enrollees, their representatives, or providers, on behalf of the enrollee can voluntarily request plan approval for any service, item, or Part B drug they believe should be covered.
  3. Advanced Beneficiary Notices (ABNs) are no longer valid for organization determinations. Integrated Denial Notices (IDNs) must be used to inform enrollees of non-coverage.
  4. When an MA plan informs an enrollee that a service is not covered, in whole or in part, it must issue the Integrated Denial Notice (IDN) or include the same OMB-approved standardized language in its Explanation of Benefits (EOB). The failure to provide notice via the OMB-approved standardized language contained in the IDN or via a clear exclusion in the plan’s EOC means the enrollee is not liable for items, services or Part B drugs provided by a contracted provider or upon referral from a contracted provider.
  5. The grievance, coverage request, or appeal timeframe begins upon receipt of representative documentation. Plans must audit these processes to identify and correct errors as needed.
  6. Effective January 1, 2025, a request for review of a dismissal must be filed within 65 calendar days from the date of the plan’s dismissal notice, similar to requesting a timely appeal of an initial determination.
  7. Non-contracted providers have rights related to organization determinations and appeals[2] including appealing a denied claim, provided the non-contract provider completes a Waiver of Liability.

Audit Protocols for Organization Determinations, Appeals, and Grievances (ODAG)

We are about six (6) weeks from the end of the 2022 cycle[3], there is time to review the new and changed features of the audit protocol (CMS 10717) for CY 2022. It’s time we highlight and focus on the changes in the protocol for Organization Determinations, Appeals and Grievances (ODAG) – what to look for during an audit, best practices for ODAG and share some of our audit experiences[4]. For an overview of the protocol changes for CY 2022, please visit https://www.inovaare.com/blogs.

  1. Universe tables have been streamlined from thirteen (13) to six (6).The audit elements to be tested remain the same – timeliness, processing and classification of coverage requests.
  2. Table 6, Dual Special Needs Plan – Applicable Integrated Plan (AIP) Reductions, Suspensions, and Terminations (AIP) is required if the plan sponsor (Sponsor) is determined to be an applicable integrated plan[5] and has been notified by CMS of their status.
  3. Part B drug is a new data field in Table 1 Standard and Expedited Pre-Service Requests for Organization Determinations (OD).

Common Audit Risks in ODAG: Best practices to address them

CMS selects 60 targeted samples for the ODAG audit to ensure enrollees have appropriate access to health care services and medications and to verify plan sponsors (Sponsors) adhere to selected aspects of their contracts with CMS. Compliance Standard and Method of Evaluation are outlined in the protocol.

CMS underscores that Sponsor has adequate process to make appropriate clinical decisions based on National Coverage Determination (NCD), Local Coverage Determination (LCD) or internal coverage policies[6].

In our experiences, several areas represent the most common risks for Sponsors in an ODAG audit.

  1. Inappropriate Denial of Care: Improper denial of plan-directed care, failure to require a waiver of liability (WOL) from non-contract providers (NCP), and exclusion of appeal rights in denial notices can result in enrollees facing unnecessary out-of-pocket expenses for medical services.

    Best Practices: Claims department staff should be trained to spot plan-directed care when denying payments to NCP. WOL should be part of the denial notice to NCP as are appeal rights. Regular monitoring of claims and denial notification can mitigate this risk.
  2. Incorrect Cost-Sharing: Failure to update fee schedules led to incorrect provider payments, causing enrollee overcharges or delayed refund of overpayments.

    Best Practices: Automate fee schedule updates for in-network and out-of-network claims to avoid errors and delays.[7] Sponsors should have an established procedure to avoid outdated fee schedules.
  3. Part B Drug Compliance Oversight: Inappropriate adjudication of Part B drugs often stems from lack of coordination. Since 2019, some Sponsors have applied step therapy for Part B drugs, covered under ODAG and Part C benefits[8]. The 365-day lookback applies, with turnaround times matching Part D: 24 hours for expedited and 72 hours for standard requests.

    Best Practices: Sponsors should document the ODAG process for Part B drugs, typically managed by the Utilization Management department. Some Part B drugs are adjudicated by Pharmacy Benefits Managers (PBMs) due to their distribution through community pharmacies. Copayments for these drugs must be tracked alongside other Part B services to prevent enrollees from exceeding their Maximum Out-of-Pocket (MOOP) limit.

    Regular monitoring, mock audits, and timely corrective actions are essential to ensure compliance with Medicare rules. Sponsors should validate comprehensive universe data from delegated entities, including PBMs, to prepare for audits and meet CMS requirements.
  4. Timeliness Issues: Timeliness is a recurring challenge in ODAG audits, often due to inadequate system support or training. For Dual Eligible Special Needs Plans – Applicable Integrated Plans (DSNP-AIP), written denial notices must be issued within 3 days of receiving the request. The additional 3-day allowance for written notice after oral notice does not apply. A 14-day extension is allowed only if it benefits the enrollee but is not permissible for Part B therapy.

    Best Practices: Sponsors should use tracking systems to log notification dates and times for all enrollee demographics and ensure timely processing of Part B drug requests.[9] Regularly extract and review universe data for quality and seek clarification from CMS auditors during pre-audit Webex sessions if needed prior to data integrity testing.
  5. Incorrect Categorization of Grievances: Grievances are often misclassified as coverage requests due to insufficient training of intake staff. We continue to see this as a vulnerability for Sponsors in ODAG.

    Best Practices: Conduct regular monitoring and training of intake staff, review call logs, and evaluate grievance responses (both verbal and written). This ensures timely access to covered benefits and proper handling of all complaints, reducing vulnerabilities in ODAG compliance.

Preparing for ODAG Audits: Why Accurate Data Matters?

The success of an audit hinges on a Sponsor’s ability to submit accurate data, well-organized universes, and comprehensive supplemental documentation. These components demonstrate the plan’s compliance with CMS requirements and its readiness to address any findings. Financial soundness and operational efficiency are equally critical; maintaining adequate resources ensures that the plan can meet CMS standards without disruptions.

Accurate data serves as the foundation for a successful audit. Errors or discrepancies in universe data can lead to findings, penalties, or delays in resolution. Sponsors must ensure their systems and processes are robust enough to capture and submit clean data.

Leveraging External Expertise

Given the complexities of compliance, Sponsors may benefit from engaging consultants like Inovaare. By leveraging specialized services, Sponsors can streamline their preparation, saving valuable time and resources while reducing the risk of non-compliance.

Inovaare’s expertise spans all facets of compliance. Our tailored solutions ensure that Sponsors are prepared for audits and equipped to meet evolving Medicare compliance requirements efficiently and economically.

Our team of specialists offers:

  • Data Extraction Support: Helping plans pull clean, accurate, and audit-ready universe data.
  • Mock Audit Support: Simulating real audit conditions to identify gaps and prepare for actual CMS audits.
  • Advanced Tools: Using cutting-edge system applications to systematically scrub data, detect discrepancies, and ensure compliance with CMS protocols.

For an in-depth discussion on validating universe data, navigating audit challenges, and staying ahead of CMS changes, visit our website at www.inovaare.com or call us at 408.850.2235.


[1] 42 CFR §§ 422.564 or 423.564

[2] 42 CFR Part 422 Subpart M

[3] Routine audit notification ends in July 2022 but Sponsors may still be notified of audits under special circumstances

[4] Inovaare partners with specialists that support sponsors in their CMS program audits and conduct Independent Validation audits.

[5] as defined by 42 CFR § 422.561

[6] Sponsors should rely on guidance in the order described, NCD, LCD and internal policies which could be based on clinical guidelines from commercial sources.

[7] For both Part A and B services, Medicare can change fee schedules retroactively and send addenda for updates.

[8] CMS announced the change in policy in an August 7, 2018 memo.

[9] CMS 4180-F and ODAG 508 protocol

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