After a major rework and massive consolidation of the Parts C & D Enrollee Grievances, Organization/Coverage Determinations, and Appeals Guidance back in 2019, the Centers for Medicare and Medicaid Services (CMS) is back at it with further updates to the all-important manual and guidance to Medicare Advantage (MA) and Part D plans.
As many are aware, the manual is the bible for anything related to a grievance, Part C or D coverage request, and Part C or D appeal. Many of the changes come from updated rules as well as the further refinement of the program audit protocols. When CMS discovers something in an audit that raises confusion among plans, they often take the learnings and clarify the manuals further.
Plans should be using the manual as a daily operating guide for their departments. From the manual, plans should create their policies as well as standard operating procedures. The manual can also help create Job Aids for complex areas, such as identifying an inquiry, coverage request, appeal, or grievance.
The changes are effective immediately and will be subject to program audits likely next year.
Recent audits show plans ignore basic manual guidance
Surprisingly, on recent audits, findings were made on basic issues that are clearly in the manual. As examples:
- Requests were not processed timely.
- Coverage requests were misclassified and processed only as grievances.
- Staff did not recognize complaints about access to, or cost of, medications as coverage requests.
- Outreach for necessary clinical information was not conducted prior to dismissing requests.
- Reasons for denial were not specific to requested services.
- Notifications were incorrect or incomplete.
- Requests were inappropriately dismissed.
- Dismissal notice templates were not updated to include the reason for the dismissal, the right to request the plan vacate the dismissal, or the right to request redetermination of the dismissal.
For more on this topic, see my recent blog on the 2023 program audit report and what I know about 2024 audits here: https://www.healthcarelabyrinth.com/2023-medicare-advantage-and-part-d-program-audit-enforcement-report-out-what-does-it-tell-us/
So, what are the new changes in the further rework of the manual?
I am highlighting the key changes in the manual. You can see all the changes in the latest update to the manual. They are marked in red in the draft. Manual site: https://www.cms.gov/medicare/appeals-grievances/managed-care . In many cases, I have lifted langauge directly from the manual. In some cases I have added commentary.
Further, if there are differences between statute or regulations and the manual, the statute or regulations control over the manual (and any other guidance). So, you must always consult the applicable statutes, regulations, and final rules.
CMS says questions regarding the updates or content may be submitted to https://appeals.lmi.org.
Expansion of what constitutes an initial coverage request
The manual clarifies and significantly expands what constitutes a coverage request for an initial determination for Parts C and D. A Part C or Part D coverage request is not bound by the timing of the party’s coverage request (e.g., before, during, or after the provision of items or services) and regardless of whether the item or service is subject to prior authorization. For Part C, enrollees, representatives, and providers have the right to voluntarily request plan approval of any service, item, or Part B drug which they believe are, or should be, covered by the plan —including non-covered services, items, and Part B drugs and again those for which the plan does not require prior authorization.
What is interesting here is that this does make previous Part C and D guidance the same. In the past, Part D treated all items largely as coverage requests, while Part C guidance allowed the classification of some items as inquiries (e.g., did not require authorization.)
If a plan does not have enough information to make an approval decision on an item, service, or drug request, it should make reasonable and diligent efforts to obtain all necessary information. This is a key audit finding in Part C recently.
Dismissals
Plans cannot dismiss a request for initial determination for any reason not explicitly listed in the applicable regulations. Further, they cannot dismiss an otherwise valid appeal from an adverse coverage decision solely because the enrollee already received the item or service that is the subject of an appeal. The manual is now explicit that the appeal should be processed completely, with a sustain or overturn decision made.
Expertise in field required to deny requests
Consistent with recent updates to regulations, Part C Organization Determinations that a plan expects to be partially or fully denied based on medical necessity must be reviewed by a physician or other healthcare professional with expertise in a field of medicine that is appropriate for the services at issue. In general, this was the guidance for years, but many plans allowed medical directors without specific expertise in an area to adjudicate requests.
Clarification on notifications
Plans should not use the Advanced Beneficiary Notice of Non-Coverage (ABN) to notify enrollees that a service is not covered but must instead use the Integrated Denial Notice (IDN). The failure to provide the required notice will result in the enrollee being held harmless for items or services provided by or upon referral from a contracted provider.
Appointment of representatives, standing, and grievances, payments, etc.
Several changes were adopted in the manual on the appointment of representatives (AORs), including clarifying who may act or be appointed as a representative.
The manual clarifies that, in the case of verbally submitting grievances, initial determinations, and reconsiderations, enrollees cannot verbally appoint a representative and must submit a valid representative form. However, if a representative makes a verbal request and the enrollee verbally confirms it, the request must be documented and processed as a request from the enrollee. Communication then should be delivered to the enrollee until valid representation is on file. The clarification says that plans are not required to make efforts to obtain a written representative form in this type of instance.
With regard to direct member reimbursement, only an enrollee or an enrollee’s representative (which could still be the prescribing physician or other prescriber) may appeal an adverse reimbursement decision under Part D.
An authorized party (e.g., billing agency) can submit a payment appeal request on behalf of a non-contracted provider without a valid AOR when the billing agency can provide evidence the provider furnished the billing agency authority to prepare a claim and receive payment on behalf of the provider or that the billing agency otherwise has authority to pursue appeals. However, the billing agency may not sign the Waiver of Liability (WOL) on behalf of the provider.
Grievances
The changes state that the grievance process is only available to enrollees or their representatives.
Plans are not required to process grievances when the grievance is submitted by a person not permitted by the applicable regulation. If representative documentation is missing, the plan should notify the enrollee and purported representative that the plan is unable to process the grievance and include instructions on how to resubmit. Plans should, but are not required to, investigate what might have been a quality-of-care grievance situation. No notification to an enrollee is required.
Providers cannot file grievances on behalf of enrollees. Providers should file complaints in accordance with the plans’ provider dispute resolution processes.
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.
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— Marc S. Ryan