How CMS’ File and Use can assist Medicare Advantage Organizations

6 minute read
How CMS' File and Use can assist Medicare Advantage Organizations
“Keep ‘em honest” often refers to important business activity checks and balances. An area in the Medicare Advantage (MA) industry needing oversight to achieve exactly this, includes the accuracy of File and Use marketing materials subject to requirements by the Centers for Medicare & Medicaid Services (CMS). Competition between insurers is fierce during each year’s Annual Election Period (AEP), and so is the temptation to push boundaries with CMS’ marketing and advertising regulations. So how does CMS help “keep ‘em honest” during the AEP’s annual crunch to support MA plans, in launching a timely and accurate marketing campaign?


To assist Medicare Advantage Organizations (MAO), CMS needed to establish review criterion for materials truly needing examination before use. Materials presenting less risk for impacting enrollment decisions were determined acceptable for use without an up-front review and approval by CMS, with the understanding the document may experience a random audit after the fact (also called “retrospective review”). CMS created this less stringent approach for marketing materials, calling it File and Use. Initially, the File and Use privilege needed to be applied for, and upon approval CMS allowed MAOs to distribute specific types of advertisements and select model documents just five days after uploading the material to CMS. Being granted this privilege greatly increased the organization’s timely promotion of both existing and new plans.

File and Use privilege 

In more recent years, CMS has opted to simply grant the File and Use privilege to new plans, with the understanding the privilege could be revoked if non-compliance was confirmed. Additionally, CMS has shifted select marketing pieces between their own filing requirements over time, to the more expedient File and Use platform. Some of the more familiar items previously subject to a 45-day review included the Summary of Benefits, television advertisements, MA website pages and radio scripts.

Simply granting the File and Use privilege without application has benefits and drawbacks. New MAOs can get their marketing pieces out quickly, which helps with sales. Yet being a new plan in the marketplace might actually warrant a demonstration of understanding marketing rules, before entering CMS’ regulatory arena. Mistakes can be so easily made and are very costly to plans and their enrollees. Considering the risks, is automatically granting the privilege for File and Use really such a good idea?

The challenges of the 45-day review period

Accelerating the timeline for these detailed marketing tools to reach prospects is an unquestionable advantage for CMS and the plan sponsors offering MA plans. Doing so greatly reduces the necessary CMS manpower for reviewing, and health plans aren’t required to wait a grueling 45-days to learn if a piece is approved. Disapproved pieces require re-work and a resubmission by the plan, which means yet another 45-day waiting period for a response. Rarely are MA health plans able to backdate campaign strategies to allow for 90 or more days before learning if a piece is even usable. In fact, model documents which qualify for File and Use, can be disqualified from that quicker distribution process if they stray from their boilerplate language for model requirements. When stripped of File and Use, documents must be submitted for a 45-day review by a CMS plan manager or designated document reviewer. This is why stringently adhering to models and ensuring accurate compliance to the rules is so critical to health plan operational communications timelines.

What about beneficiaries inundated with information about plan options? Who is looking out for their interests to hold plans accountable for accuracy before infomercials have a chance to display their beckoning toll-free numbers across the screen?

Ever since CMS slid MAO television commercials and radio scripts off the review list, envelopes (which believe it or not are also considered marketing materials) have been pushed, resulting in an uptick of either confusing or misleading marketing practices to the degree CMS had to draw a line. In October 2022, CMS announced the return of a 45-day review period for radio and television advertisements due to numerous marketing violations, including misleading plan information. “With television marketing specifically, CMS is concerned that MA sponsors overpromote plan benefits and savings to individuals that may not be eligible, along with using confusing words and imagery.” The misleading infomercials sometimes featured trusted celebrity figures offering assurances and urging viewers to change plans, which magnified the deception of Medicare beneficiaries.

Concerns with deceptive marketing

While mistruths in marketing are rarely intentional, even MAO compliance professionals and marketing directors can be challenged to accurately interpret constantly changing CMS guidance. Whether inadvertent or deliberate, marketing practices have gone awry to the degree of attracting attention by the United States Senate Committee on Finance. The Committee’s 2022 report “Deceptive Marketing Practices Flourish in Medicare Advantage,” analyzed eight genre of stakeholder participants who actively marketed plans in the MA industry, and concluded the following:

“The pattern of problematic and deceptive marketing activity by private plans identified by this investigation threatens consumer protections under Medicare and suggests a number of commonsense regulatory changes to put the needs of the beneficiary first. This year, CMS has taken some positive steps to address concerning trends, including requiring TPMOs to provide the disclaimer that they do not represent all plans and sub regulatory guidance released in October announcing that CMS would resume the conduct of secret shopper studies during the 2023 open enrollment period and start proactively reviewing television advertisements.”

As CMS again ramps up its Secret Shopper programs, it will be interesting to see whether other benefit-heavy documents, currently allowed under File and Use, join the ranks of television commercials now requiring a 45-day review. One marketing material that could easily fall under similar scrutiny is the CMS-required Summary of Benefits (SB). A recent Toppan Merrill webinar discussed this unique, and by CMS definition, model document. However, the SB’s rules allow MAOs significant liberties to add creative marketing language beyond CMS-prescribed contents. The Summary of Benefits documents are not currently examined for approval before use. CMS has been conducting retrospective reviews of SBs to identify errors. Considering the SBs are not reviewed and are heavily relied upon as an enrollee decision-making tool, could they be the next advertising tool disqualified for File and Use?

Apart from very few exceptions (such as with employer group plans), non-permissible alterations to standardized models are a violation of CMS marketing materials guidelines. Straying from model requirements could additionally force standardized documents into a category of “non-model” member materials, possibly necessitating a CMS 45-day review period.

How Toppan Merrill can help

Toppan Merrill’s Member Communications Consulting division specializes in creating accurate documents for an MAO’s model and marketing materials. We help our clients prepare for a successful AEP by identifying errors that may cause our MAOs to inadvertently break stride with CMS model requirements, saving our clients time and money.

Toppan Merrill provides solutions that help you respond quickly to regulation changes, member needs and market needs. We offer several services including document creation and management, sales enablement, omni-channel communications, printing services and more.

Summer Beach – Associate Director, Medicare Compliance Solutions

With more than 30 years of insurance industry experience, Summer Beach is an industry thought leader and expert on Medicare-related compliance. Her background includes past roles as Regulatory Compliance Manager and Compliance Director for state, regional and national insurers. Her areas of expertise include CMS-regulated documents and guidelines, agent/broker and sales compliance, designing CMS-approved investigation processes, audits, Corrective Action Plans, and training with re-education formats following CMS disciplines. Summer brings expertise on policies and procedures, auditing compliance programs and has measurably reduced plan member complaints to CMS through remedial initiative.

Summer Beach – Associate Director, Medicare Compliance Solutions's Photo

Related Insights

When you’re ready to optimize, we’re ready to help.