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Because Health Care is Not Regulated Enough: Very Specific Compliance Training Program Required as of January 1, 2016!

Health Law Alert Sarah E. Coyne, Jon R. Kammerzelt

You health care providers really have it so easy. No rules, no obstacles, nothing is illegal…health care is like the Wild West of old. Well, that would be true if the westward-traveling pioneers were required to obtain six separate permits for every cow or horse they owned, each with conflicting requirements. Sadly, one cannot take a single step in the cow pasture that is current health care regulation without having to wipe off one's (metaphorical) shoe thereafter.

To make things even crazier, regulation is not just for regulators anymore—hospitals now find themselves in a really super fun governmental-health plan regulatory sandwich. Here is how it works: The Centers for Medicare and Medicaid Services (CMS) require that Medicare Advantage Plans (MA Plans – Part C) and Prescription Drug Plan Sponsors (PDPs – Part D) require each of their "First Tier, Downstream and Other Related Entities" (collectively FDRs) to conduct very specified, prescribed compliance training.

Now, here is the bad news: FDRs of Medicare Advantage Plans and Prescription Drug Plan means you, hospitals and other health services providers. This means that you now have an affirmative and looming deadline for incorporating CMS modules into your compliance training. While it appears (somewhat murkily) that you do not have to complete the training by January 1, 2016, you have to incorporate it into your program and policy, and you must comply with the timing requirements for training employees thereafter (so much for the Wild West, huh Cowboy?). Other relevant information:

When Do You Care? January 1, 2016. Happy Holidays! Get compliant! Our advice: You should care right now.

What Do You Have to Do? Assuming you contract with Medicare Advantage Plans or Prescription Drug Plan sponsors, you need to adapt your compliance training to include the CMS module for general compliance, and possibly (although probably not) also the CMS module for Fraud Waste and Abuse (FWA). Fortunately, CMS has provided materials online for you to do this, available here. You may ADD TO the training but you may not MODIFY the training. (Don't mess with the modules! CMS has spoken.)

There are two training obligations as an FDR: 1) Fraud Waste and Abuse (FWA) training; and 2) general Medicare compliance training. You must do both—with one caveat regarding FWA training, explained below.

What is the Caveat About FWA Training? If you are enrolled in Medicare Part A or B (i.e., pretty much all of you), you are already obligated to do FWA training, and you need not do anything differently. It might be to your advantage to clearly label your existing training as FWA training so that you are prepared in the event of audit by one of your contracted plans, but basically you are good to go on that component of the requirement.

Who Should Receive the Training? Your employees (stay tuned) and your downstream entities (stay tuned for this too). (And try to control your excitement, for goodness sake, we can feel you trembling in your cowboy boots as you read this).

Which Employees Should Be Trained? The plans themselves are required to train all employees. While your obligation as FDRs is less clear, we, your wise (and very good looking) authors believe that the obligation extends only to those who perform clinical or administrative services related to the plans. This probably leaves out housekeeping, food service, etc. Plans have taken varying positions on in notifying FDRs of their training obligation. At least one plan has informed FDRs to train all employees but your authors think that plan may have just adapted its own obligations in crafting its documents to send to FDRs, and would be open to negotiation on this point.

When Should Employees Be Trained? Existing employees should be trained as soon as possible. New employees should be trained within 90 days of hire. All employees should be trained annually thereafter.

How Do You Figure Out Who Your Downstream Entities Are? We have no idea. Figure it out yourself. Okay, okay, that was not good business development technique on our part and also we were lying. We do have some idea. Downstream entity means any party that enters into an acceptable written arrangement below the level of the arrangement between an MA organization (or contract applicant) and a first-tier entity. This casts a very large net, we realize, so our advice is that you limit your downstream entities…now brace yourself, because this may bring on a wave of déjà vu for those who perform administrative or clinical services related to the Medicare Part C or Medicare Part D plan functions.

How Do You Prove That You Complied With These Requirements? There are two options for demonstrating completed training to the plan: (1) certificate of completion from each individual; and/or (2) an attestation from the entity that the facility has completed the required compliance training. FDRs must maintain certificates or other documentation of training completion for up to 10 years. Documentation of training must include employee names, dates of employment, dates of completion, and passing scores (if captured). FDRs must furnish (upon request) evidence of training such as certificates of completion, training logs, system generated reports, and spreadsheets. Deemed providers must maintain evidence of FWA training, even if not using CMS module.

Next Steps

  • Do you contract with Medicare Advantage (Medicare Part C) plans or Prescription Drug Plan (Medicare Part D) sponsors? If not, why are you still reading this? This does not apply to you. Stop reading now and go have a cup of coffee or a stiff drink.
  • Go to the link to download the compliance training, available here.
  • If you are enrolled in Medicare Part A or B, you do not need to use the FWA module—but please make sure you are doing FWA-related training and ideally it should specifically be labeled as FWA training.
  • Figure out your training schedule—initial training, annual training and training of new hires within 90 days of their start dates.
  • Figure out how you will execute the training (e.g., online, presentation, videotape, paper distribution, or some combination thereof).
  • Once the program is implemented (Note: This does not mean that everybody is trained —it means that you have the program implemented) provide an attestation or individual certificates to the plans with which you contract.

For questions, please contact Sarah Coyne at (608) 283-2435/sarah.coyne@quarles.com, Jon Kammerzelt at (608) 283-2438/jon.kammerzelt@quarles.com, or your Quarles & Brady attorney.