Category Archives: Tentative Notices of Overpayment

Federal Court Vacates Two, Medicare ALJ Decisions with Extrapolations

Today is April Fool’s Day, but the story I am going to tell you today is no prank. On 03/25/2024, the U.S. District Court of the Southern District of Florida rendered its Decision on MedEnvios Healthcare, Inc. v. Xavier Becerra, in his official capacity as Secretary USDHHS. 2024 WL 1252264. The federal Court vacated two, ALJ Decisions upholding two, separate, extrapolated audits. This example highlights the importance of appealing ALJ Decisions to federal court, which will uphold the law versus CMS Rules.

MedEnvios is a durable medical equipment provider (DME). It was the target of two Medicare audits and both audits were extrapolated. MedEnvios’ argument is two-fold: (1) that its due process rights were violated because HHS failed to comply with the procedures set forth in statute, regulation, and “sub-regulatory guidance” that mandate “certain due process minimum protections be provided to health care suppliers in the statistical sampling and extrapolation process.” (Pl.’s Resp. at 9.) Specifically, MedEnvios objects to the Defendant’s exclusion of claims for which the Department never made a payment to MedEnvios from the sampling frame. Obviously if the zero-claims are not removed the number will be inflated or maybe even surpass what was actually paid to the provider during the specific timeframe. And (2) MedEnvios argues that the Defendant failed to provide sufficient documentation to support overpayments recalculated following partially favorable appellate decisions, allegedly depriving MedEnvios of notice. Following partially favorable decisions on appeal, the relevant contractor must “effectuate” the decision by recalculating the extrapolated overpayment amount to be recouped from the supplier based upon the revised decisions on individual sampled Medicare claims. The contractor then sends the supplier a revised demand letter reflecting the new overpayment amount. Without the underlying documentation showing how the contractor arrived at the new amount, MedEnvios claims that it lacked “the information necessary to mount a meaningful challenge to those recalculations.”

I bet that many readers today have felt the pain of having to defend themselves from an audit and knew the auditor was withholding data or documents, yet felt powerless. This Decision says it is not ok to not give all the information. The Court held that MedEnvios was and is prejudiced by the unavailability of the recalculation worksheets because MedEnvios did not receive three of the four relevant recalculation worksheets within enough time to satisfy its procedural due process rights by recreating the recalculations to verify the revised extrapolated amounts.

The Court held that the prejudice to MedEnvios in having to mount appeals without reviewing the contractors’ effectuation work easily outweighs any administrative difficulty of timely providing the worksheets. Provision of this information should be a negligible burden on the Department and its contractors. The MPIM already instructs that “[d]ocumentation shall be kept in sufficient detail so that the sampling frame can be re-created should the methodology be challenged. The contractor shall keep an electronic copy of the sampling frame.” MPIM § 8.4.4.4.1. Thus, contractors are already required to maintain this information, and the added burden of providing the information on request would be minimal. The Court therefore concludes that the Department has run afoul of MedEnvios’s procedural due process rights by failing to provide the documentation supporting the recalculated overpayment amounts.

So, what is the remedy for the Department’s failure to timely provide documents showing how the revised overpayment demands were calculated?

This Court vacated both ALJ Decisions upholding the two extrapolated amounts. This is a perfect example of why providers MUST appeal ALJ Decisions to federal court. The difference in the law and CMS’ Rules is vast. Not enough providers continue their appeal to federal court because of money. Litigation is expensive. However, in this case, attorneys’ fees were, most likely, much less than what CMS was alleging MedEnvios owed.

Have a great April Fool’s Day. Play a prank on a colleague. At the office, put tape under a coworker’s computer mouse, and watch them try to figure out why it’s not working!

In Medicare Provider Audits, the Best Defense Is a Good Offense

Today I want to discuss upcoming 2024 audits. It has been almost four years since the world shut down due to COVID. Life has been divided into “before COVID” and “after COVID.” Before COVID, the Centers for Medicare and Medicaid Services (CMS) aggressively pursued audits against durable medical equipment suppliers, home health, hospice, behavioral health, long term care facilities and hospitals. When COVID hit, most audits were paused. But not for long. As you know, CMS resumed its audit activities as early as August 2020. However, in the world of COVID, there were exceptions to every rule, many of which were state specific. Even exceptions had exceptions. It is imperative that you maintain for your type of health care service every policy, exceptions, bulletins, advisory opinions from 2020 through the present. If you have not assigned this task to someone in your facility, do it today.

We have seen an uptick in increased audit activity with pneumonic compression devices (PCDs). PCDs were not listed in the top error rates for the 2021 Improper Payment Report, but in the 2023 report, PCD’s have the second highest error rate behind oral cancer drugs at 78.9%. With an error rate that high, PCD’s will be a focal point of audits. Other items identified in the 2023 improper payment report for having high error rates include urological supplies, parenteral and enteral nutrition, manual wheelchairs, and various orthoses. These items will all see increased audit activity in the upcoming year. Basically, as long as the error rates remain high, audit activity will continue.

Surgical dressings have also been consistently audited. Surgical dressings are relatively a complex product to bill. DME suppliers of surgical dressings and physicians who order surgical dressings are seeing an uptick in denials. The 2021 Medicare fee for service supplemental improper payment report covering claims from July 1st, 2019, through June 30th 2020, listed surgical dressings as having the highest improper payment rate at 69.7%, followed closely by therapeutic shoes with an error rate of 67.9%. Since then, there has not been much improvement. The 2023 Improper Payment Report covering claims submitted between July 1st, 2021, and June 30th, 2022, shows the improper payment rate for surgical dressings is still at 62.1%. Therapeutic shoes did show some improvement with an improper payment rate of 51.4%, but this is still significant. For the 2023 reporting period, insufficient documentation accounted for 82.4% of improper payments for surgical dressings. Other types of errors for surgical dressings were no documentation at 1.9%, medical necessity at 1.7%, incorrect coding at 1.9% and other at 12.2%.

Targeted Probe and Educate (TPE) were some of the first audits resumed by CMS. Recovery Audit Contractor (RAC) audits are also increasing. I consider RACs to be the bounty-hunters of Medicare and Medicaid. Audits of skilled nursing providers are going to see a hike this year, with a growing number of federal and state recovery audits adding to specialized compliance reviews announced last year. In 2023, regulators instituted audits of facilities using potentially inappropriate diagnosis of schizophrenia as well as a new, 5-claim audit of every US nursing home that was specifically meant to root out improper payments. CMS came under additional pressure this past summer. That’s when the Government Accountability Office said the agency needs to do a better job of recouping overpayments. What do we think CMS will do in light of the GAO instructing the agency to do a better job recouping? The answer is: audit more. But, as they say in football, the defense is a good offense. The same is true in Medicare and Medicaid provider appeals. Be prepared.

RAC Audits Are BOO-Very Scary, and, Sometimes, Are DEAD wrong!

For Monitor Monday, today, October 30, 2023, I dressed up as a RAC auditor. BOO!!! I get a spooky 13.5% commission for overzealous auditing tactics. RAC auditors come in every shape and size, color or gender.

In my experience, RACs are garishly incorrect in their assessments. I will reveal three, real life examples where these audit contractors accused healthcare providers of owing money but were found to be dead wrong:

Example 1 – Medical Necessity quibbles:

In a haunting case involving a hospital, the RAC alleged that certain cardiac procedures were billed inappropriately, citing concerns about the medical necessity of these services. They claimed the hospital should refund a repugnant amount for these procedures. However, upon closer examination and an appeal process, it was revealed that the services were indeed medically necessary and aligned with the standard protocols. The ghastly RAC’s accusation was disproven, and the hospital was not required to return any funds. Spine-tingling!

Example 2 – Improper Coding of Diagnosis:

A healthcare provider, particularly a large physician group, was accused by the RAC of using suspicious, improper diagnostic codes, leading to overbilling for certain services provided to Medicare and Medicaid beneficiaries. After a thorough internal audit, it was determined that the codes used were accurate and supported by the patient’s medical records. The RAC’s allegations were unfounded, and no repayment was required. Suspicious. A haunting reminder to spook audits.

Example 3 – Alleged Duplicate Billing:

In a murderous case involving a nursing facility, the RAC identified what they believed were instances of duplicate billing for certain procedures and services. Upon further review, it was revealed that the billing discrepancies were due to the RAC’s misunderstanding of the facility’s billing processes. Mysterious. The facility provided evidence showcasing that the billed services were distinct and not duplicates. Consequently, the RAC’s claim was refuted, and no repayment was deemed necessary. Suspicious.

These examples underscore the critical need for providers to have robust internal compliance measures in place. While RACs serve a vital purpose in identifying billing errors, they are not infallible. Providers need to be equipped to challenge these audit findings, ensuring they are based on accurate and comprehensive information.

It’s crucial for healthcare providers to engage in a proactive approach by conducting their internal audits, maintaining accurate documentation, and being prepared to challenge RAC determinations when necessary. These efforts not only protect providers from unwarranted financial obligations but also ensure that Medicare and Medicaid funds are appropriately allocated.

In conclusion, the relationship between RACs, healthcare providers, and government healthcare programs is complex. The examples provided demonstrate that while RACs play a critical role in safeguarding the integrity of Medicare and Medicaid, their findings are not always accurate. Providers must be diligent in ensuring their billing practices align with regulations and be prepared to contest any erroneous audit findings to maintain fiscal stability and fair reimbursement for services rendered.

Happy Halloween!!!!

RAC Audits: If It Walks Like a Duck and Quacks Like a Duck, It Is a Duck!

Today, I am going to talk about RAC audits. I know what you are thinking…don’t you always talk about RACs? Of course, you are going to talk about RAC audits. No. Today, I’m taking this blog in a different direction.

I want to talk about secret, hidden RAC audits. As you are aware, the federal regulations limit RACs from going back more than 3 years to audit claims. Juxtapose the UPICs, TPEs, SMRCs, MACs, OIG, and even State Medicaid agencies. Everyone, but the RACs are allowed more than a 3-year lookback period. Some, like OIG, have long lookback periods. Coincidentally, when a company responds to an RFP or a request for proposal from CMS to act as CMS’ vendor to conduct Medicare audits on America’s Medicare providers, a clause in the proposed contract between CMS and the vendor is highly argued or negotiated. Which clause in the vendor’s contract is most negotiated? I will tell you. The clause that states that the vendor is a RAC is most negotiated. Because if the vendor is called a UPIC instead of a RAC, the vendor has a longer lookback period. Being called a UPIC, suddenly, becomes a commodity. There are no laws mandating UPICs to a 3-year lookback period. All of a sudden, it is not hip to be a RAC.

Look into it. Do your research. The contracts are public record. Ask for Cotiviti’s contracts with CMS. Notice I said contracts, not contract. What I have realized over time is that a vendor may be hired by CMS to be a RAC auditor, but, once the vendor realizes the limit of 3 years, it goes back to CMS and asks if it can be considered an UPIC. Why? A UPIC can do everything that a RAC does; however, it gets an additional 3 years to lookback at claims and that means money. Cha-ching!  Even Dr. Ron Hirsh commented today on RACMonitor about this story, which I presented this morning at 10:00am, as I present every Monday morning, live, on the national podcast RACMonitor , hosted by Chuck Buck and produced by MedLearn. If you want to listen to the podcast, click the following link: Nelson Mullins – Monitor Mondays Podcast Featuring Knicole Emanuel; Defeating Statistical Extrapolations, Expansion of Medicaid RACs, IPPS Final Rule, Smart Hospitals, and Physician Advisors Episodes

The podcast is also on video, but I don’t know how to view that. If you do, you would see my baby duck Biscuit on the screen. He joined me this morning to talk about, “What Walks Like a Duck and Quacks Like a Duck, Must be a Duck.” Dr. Hirsh commented that companies like Cotiviti have many, many contracts deeming Cotiviti many different acronyms. If you get a letter from Cotiviti, do not assume it is acting as a RAC. Instead, ask for the contract which allows Cotiviti to do what it purports to want to do.

I’ve noticed this trend in real life, but only for 10-20 individual cases, maybe 30. I have not had the time to draft a FOYIA request, and, quite frankly, my name on a FOYIA request nowadays result in a response that says, something to the effect of, use discovery instead. Even though my personal experiences should not be extrapolated across the country because that would be inappropriate and judgmental, I will give an example and you may extrapolate or not. There is a company that has been doing RAC audits in NC for the last 5-8 years. It is called Public Consulting Group (“PCG”). PCG and I go way back. If you are a longtime listener of RACMonitor, you will recall that Ed Roche and I presented numerous podcasts about the debacle in NM in 2013. The State of NM put 15 Medicaid providers who constituted 87.6% of the BH providers in NM at the time. The consequences were catastrophic; thousands were out of BH services overnight. There is even a documentary about the unraveling of BH in NM in 2013. The reason that these 15 BH providers were put out of business overnight was because of a NM vendor called PCG. PCG issued a report to NM after conducting Medicaid audits on these 15 BH facilities, which accused the 15 facilities of fraud. In 2013, PCG was considered a RAC per contract. Today, when I have a case against PCG and make the 3-year lookback period argument, I get a retort that it’s not a RAC. Instead it’s a UPIC.

To which I say, if it walks like a duck and talks like a duck, it is a duck.

What To Do When Your Doctor Fails To Doctor?

Not everyone loves their job. Not everyone has a job. Not everyone does their job. And that includes doctors and lawyers. Not all doctors and lawyers do their jobs well. When a doctor fails to doctor, where does the liability lie? On the facility? On the hospital?

That is exactly what happened in one of my cases. My client, an inpatient substance abuse facility, hired a physician. Upon hire, the doctor signed an employment agreement that stated that he or she would perform the role as a doctor/medical director for the facility. Years passed. There were no complaints, so the executive committee was under the impression that the doctor was fulfilling his duties. The members certainly had no reason to suspect that the doctor was not doctoring according to the employment contract. No, they assumed that a doctor would doctor.

Then a RAC audit happened. As you are well aware, RAC audits go back three years. The facility received a Tentative Notice of Overpayment from the RAC alleging the facility owed almost $10 million. I was hired, and I conducted a review of the facility, its policies, and interviewed all staff. It came to light that the doctor did not review the results of urinalysis tests. Remember, this is a substance abuse facility. Urine tests are essential. The Medicaid recipients provided the samples; they peed in a cup. The labs were ordered. The doctor has a standing order for definitive and presumptive urinalysis tests. The doctor has sole access to the test results electronically. We discovered, much to our horror, that the doctor never looked at the results. For the past three years, she has never informed any patient that they were or were not positive or negative for any substance. In my mind, reviewing the urinalysis results goes hand in hand with substance abuse therapy.

Here, we discovered a breakdown in the facility, but that breakdown was one person not doing his or her job. Sadly for him or her, we – the facility – were able to use the doctor’s failure to doctor to our advantage. We appealed the $10 million alleged overpayment. Our primary defense was throwing the doctor under the bus, and we had every right to do so. Who would have expected your medical director failing to direct or review pertinent tests. In the world of law, respondeat superior, normally, is the general rule. In Latin, respondeat superior means that the superior or the boss or the owner is responsible for those underneath them. In this case, the facility is the superior and the doctor is the inferior, so you would expect the facility to bear any liability of its employees. But, not here. Not in this case. The doctor failed to meet expectations of the job. By not reviewing urinalysis test results, the doctor veered enough off the track to relieve liability from the facility. The doctor’s inactions were the direct cause of the accusation of owing $10 million. The administrative law judge (“ALJ”) agreed. After terminating the doctor, we contemplated suing the physician for damages. However, since we won the alleged overpayment case, we did not do so.

Ding Dong! PHE Is Dead!!!

The federal Public Health Emergency (PHE) for COVID-19, declared under Section 319 of the Public Health Service (PHS) Act, is expiring at the end of the day on May 11, 2023, today! This is huge. There have been thousands of exceptions and waivers due to COVID throughout the last 2 1/2 years. But on the end of the day on May 11, 2023…POOF….

Most exceptions or waivers will immediately cease.

The Department claims it has been working closely with partners—including Governors; state, local, Tribal, and territorial agencies; industry; and advocates—to ensure an orderly transition out of the COVID PHE.

Yesterday, HHS released a Fact Sheet. It is quite extensive, as it should be considering the amount of regulatory compliance changes that will happen overnight!

Since January 2021, COVID deaths have declined by 95% and hospitalizations are down nearly 91%.

There are some flexibilities and actions that will not be affected on May 11.

Access to COVID vaccinations and certain treatments, such as Paxlovid and Lagevrio, will generally not be affected. 

At the end of the PHE on May 11, Americans will continue to be able to access COVID vaccines at no cost, just as they have during the COVID PHE. People will also continue to be able to access COVID treatments just as they have during the COVID PHE.

At some point, the federal government will no longer purchase or distribute COVID vaccines and treatments, payment, coverage, and access may change.

On April 18, 2023, HHS announced the “HHS Bridge Access Program for COVID-19 Vaccines and Treatments.” to maintain broad access to vaccines and treatments for uninsured Americans after the transition to the traditional health care market. For those with most types of private insurance, COVID vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) are a preventive health service and will be fully covered without a co-pay when provided by an in-network provider. Currently, COVID vaccinations are covered under Medicare Part B without cost sharing, and this will continue. Medicare Advantage plans must also cover COVID vaccinations in-network without cost sharing, and this will continue. Medicaid will continue to cover COVID vaccinations without a co-pay or cost sharing through September 30, 2024, and will generally cover ACIP-recommended vaccines for most beneficiaries thereafter.

After the transition to the traditional health care market, out-of-pocket expenses for certain treatments, such as Paxlovid and Lagevrio, may change, depending on an individual’s health care coverage, similar to costs that one may experience for other covered drugs. Medicaid programs will continue to cover COVID treatments without cost sharing through September 30, 2024. After that, coverage and cost sharing may vary by state.

Major telehealth flexibilities will not be affected. The vast majority of current Medicare telehealth flexibilities that people with Medicare—particularly those in rural areas and others who struggle to find access to care—have come to rely upon throughout the PHE, will remain in place through December 2024. Plus, States already have significant flexibility with respect to covering and paying for Medicaid services delivered via telehealth. This flexibility was available prior to the COVID PHE and will continue to be available after the COVID PHE ends.

What will be affected by the end of the COVID-19 PHE:

Many COVID PHE flexibilities and policies have already been made permanent or otherwise extended for some time, with others expiring after May 11.

Certain Medicare and Medicaid waivers and broad flexibilities for health care providers are no longer necessary and will end. During the COVID PHE, CMS used a combination of emergency authority waivers, regulations, and sub-regulatory guidance to ensure and expand access to care and to give health care providers the flexibilities needed to help keep people safe. States, hospitals, nursing homes, and others are currently operating under hundreds of these waivers that affect care delivery and payment and that are integrated into patient care and provider systems. Many of these waivers and flexibilities were necessary to expand facility capacity for the health care system and to allow the health care system to weather the heightened strain created by COVID-19; given the current state of COVID-19, this excess capacity is no longer necessary.

For Medicaid, some additional COVID PHE waivers and flexibilities will end on May 11, while others will remain in place for six months following the end of the COVID PHE. But many of the Medicaid waivers and flexibilities, including those that support home and community-based services, are available for states to continue beyond the COVID PHE, if they choose to do so. For example, States have used COVID PHE-related flexibilities to increase the number of individuals served under a waiver, expand provider qualifications, and other flexibilities. Many of these options may be extended beyond the PHE.

Coverage for COVID-19 testing will change.

State Medicaid programs must provide coverage without cost sharing for COVID testing until the last day of the first calendar quarter that begins one year after the last day of the PHE. That means with the PHE ending on May 11, 2023, this mandatory coverage will end on September 30, 2024, after which coverage may vary by state.

The requirement for private insurance companies to cover COVID tests without cost sharing, both for OTC and laboratory tests, will end at the expiration of the PHE.

Certain COVID data reporting and surveillance will change. CDC COVID data surveillance has been a cornerstone of our response, and during the PHE, HHS had the authority to require lab test reporting for COVID. At the end of the COVID-19 PHE, HHS will no longer have this express authority to require this data from labs, which will affect the reporting of negative test results and impact the ability to calculate percent positivity for COVID tests in some jurisdictions. Hospital data reporting will continue as required by the CMS conditions of participation through April 30, 2024, but reporting will be reduced from the current daily reporting to weekly.

FDA’s ability to detect shortages of critical devices related to COVID-19 will be more limited. While FDA will still maintain its authority to detect and address other potential medical product shortages, it is seeking congressional authorization to extend the requirement for device manufacturers to notify FDA of interruptions and discontinuances of critical devices outside of a PHE which will strengthen the ability of FDA to help prevent or mitigate device shortages.

Public Readiness and Emergency Preparedness (PREP) Act liability protections will be amended. On April 14, 2023, HHS Secretary Becerra mailed all the governors announcing his intention to amend the PREP Act declaration to extend certain important protections that will continue to facilitate access to convenient and timely COVID vaccines, treatments, and tests for individuals.

More changes are occurring than what I can write in one, little blogpost. Know that auditors will be knocking on your doors, asking for dates of service during the PHE. Be sure to research the policies and exceptions that were pertinent during those DOS. This is imperative for defending yourself against auditors knocking on your doors.

And, as always, lawyer-up fast!

And just like the Wicked With of the West, DING DONG! The PHE is dead.

Watch AND Listen to RACMonitor Mondays!!

Now you can WATCH and listen to Monitor Monday!

We went to video! Click the link to watch!

We present live every Monday, so be sure and join us. You can ask real live questions of the panelists!

https://www.linkedin.com/video/event/urn:li:ugcPost:7052380196447948800/

CMS Published 2023 Medicare/caid Health Care Providers’ Audit Process

THE CENTER FOR MEDICARE AND MEDICAID SERVICES (“CMS”) 2023 Program Audit Process Overview came out recently. The report is published by the Division of Audit Operations. CMS will send engagement letters to initiate routine audits beginning February 2023 through July 2023. Engagement letters for ad hoc audits may be sent at any time throughout the year. The program areas for the 2023 audits include: 

  • CDAG: Part D Coverage Determinations, Appeals, and Grievances
  • CPE: Compliance Program Effectiveness
  • FA: Part D Formulary and Benefit Administration
  • MMP-SARAG: Medicare-Medicaid Plan Service Authorization Requests, Appeals, and Grievances
  • MMPCC: Medicare-Medicaid Plan Care Coordination 
  • ODAG: Part C Organization Determinations, Appeals, and Grievances
  • SNPCC: Special Needs Plans Care Coordination

The Program Audit Process document is only 13 pages. Yet, it is supposed to set forth the rules that the auditors must abide by in 2023. My question is – what if they don’t. What if the auditors fail to follow proper procedure.

For example, similarly to last year, an audit consists of 4 phases.

  1. Audit engagement and universe submission
  2. Audit field work
  3. Audit reporting
  4. Audit validation and close out

I would like to add another phase. Phase 5 is appeal.

According to the Report, and this is a quote: “the Audit Engagement and Universe Submission (which is the 1st stage) is a six-week period prior to the field work portion of the audit. During this phase, a Sponsoring organization is notified that it has been selected for a program audit and is required to submit the requested data, which is outlined in the respective Program Audit Protocol and Data Request document.” My question is: The sponsoring organization? CMS is referring to the provider who getting audited as a sponsoring organization. And why does CMS call the provider who is getting audited sponsoring? Is it because after the audit the sponsoring organization will be paying in recoupments?

It is interesting that the first phase “Audit Engagement and Universe Submission,” lasts 6 weeks. At this point, I want to know, does the provider know that the facility has been targeted for an audit? As an attorney, I get to see the process in the aftermath. Folks call me in distress because they got the results of an audit and disagree. I have never had the opportunity to be involved from the get go. So, if any of y’all receive a notice of an audit, please call me. I won’t charge you. I just would love the experience of walking through an audit from the get go. I think it would make me better at my job.

In other news, as you know, CMS may issue civil money penalties to providers for alleged noncompliance. Other penalties exist as well, which may or may not be worse that civil penalties. On January 23, 2023, CMS published a correction that Total Longterm Care, Inc. d/b/a InnovAge Colorado PACE (InnovAge CO) corrected its violations. In 2021, CMS had suspended its ability to re-enroll. Another facility was imposed with pre-payment review, which means that the facility must submit claims to an auditor prior to receiving reimbursements. Pre-payment review is probably the worse penalty in existence. A client of mine was told yesterday that pre-payment review is imminent. The only recourse for pre-payment review is a federal or State injunction Staying the suspension of reimbursements. You cannot appeal being placed on pre-payment review. But you do have a chance to Stay the suspension. The suspension makes no sense to me. It’s as if the government is saying that you are guilty before an ability to prove innocence.

Medicare Auditors Fail to Follow the Jimmo Settlement

Auditors are not lawyers. Some auditors do not even possess the clinical background of the services they are auditing. In this blog, I am concentrating on the lack of legal licenses. Because the standards to which auditors need to hold providers to are not only found in the Medicare Provider Manuals, regulations, NCDs and LCDs. Oh, no… To add even more spice to the spice cabinet, common law court cases also create and amend Medicare and Medicaid policies.

For example, the Jimmo v. Selebius settlement agreement dictates the standards for skilled nursing and skilled therapy in skilled nursing facilities, home health, and outpatient therapy settings and importantly holds that coverage does not turn on the presence or absence of a beneficiary’s potential for improvement.

The Jimmo settlement dictates that:

“Specifically, in accordance with the settlement agreement, the manual revisions clarify that coverage of skilled nursing and skilled therapy services in the skilled nursing facility (SNF), home health (HH), and outpatient therapy (OPT) settings “…does not turn on the presence or absence of a beneficiary’s potential for improvement, but rather on the beneficiary’s need for skilled care.” Skilled care may be necessary to improve a patient’s current condition, to maintain the patient’s current condition, or to prevent or slow further deterioration of the patient’s condition.”

This Jimmo standard – not requiring a potential for improvement – is essential for diseases that are lifelong and debilitating, like Multiple Sclerosis (“MS”). For beneficiaries suffering from MS, skilled therapy is essential to prevent regression.

I have reviewed numerous audits by UPICs, in particular, which have failed to follow the Jimmo settlement standard and denied 100% of my provider-client’s claims. 100%. All for failure to demonstrate potential for improvement for MS patients. It’s ludicrous until you stop and remember that auditors are not lawyers. This Jimmo standard is found in a settlement agreement from January 2013. While we will win on appeal, it costs providers money valuable money when auditors apply the wrong standards.

The amounts in controversy are generally high due to extrapolations, which is when the UPIC samples a low number of claims, determines an error rate and extrapolates that error rate across the universe. When the error rate is falsely 100%, the extrapolation tends to be high.

While an expectation of improvement could be a reasonable criterion to consider when evaluating, for example, a claim in which the goal of treatment is restoring a prior capability, Medicare policy has long recognized that there may also be specific instances where no improvement is expected but skilled care is, nevertheless, required in order to prevent or slow deterioration and maintain a beneficiary at the maximum practicable level of function. For example, in the regulations at 42 CFR 409.32(c), the level of care criteria for SNF coverage specify that the “. . . restoration potential of a patient is not the deciding factor in determining whether skilled services are needed. Even if full recovery or medical improvement is not possible, a patient may need skilled services to prevent further deterioration or preserve current capabilities.” The auditors should understand this and be trained on the proper standards. The Medicare statute and regulations have never supported the imposition of an “Improvement Standard” rule-of-thumb in determining whether skilled care is required to prevent or slow deterioration in a patient’s condition.

When you are audited by an auditor whether it be a RAC, MAC or UPIC, make sure the auditors are applying the correct standards. Remember, the auditors aren’t attorneys or doctors.

District Court Upholds ALJ’s Decision that Extrapolation Was Conducted in Error

Today, I am going to write about a hospital in Tennessee that underwent an audit, and the MAC determined that the hospital owed over $5 million. The hospital challenged both the OIG contractor’s sampling methodology and its determinations on specific claims by requesting a hearing before an ALJ. The District Court decision was published in September 2022. The reason that I want to make you aware of this case, is because there have been numerous Medicare provider appeals unsuccessfully challenging the extrapolation, and the ALJs upholding the extrapolations. In this case, the ALJ found the extrapolation in error, the Council reversed the ALJ on its own motion, and the district court reaffirmed the ALJ, saying the extrapolation was faulty. Whenever good case law is published, we want to analyze the Court’s reasoning so we, as attorneys, can replicate the winning arguments.

One of the main reasons that the district court agreed that the extrapolation was faulty was because no testimony supporting the OIG contractor’s extrapolation process or the implementation of its statistical sampling methodology were submitted to that hearing on June 11, 2020, and the contractor did not appear. It’s the mundane scene with an ALJ level appeal and the auditor failing to appear to prove the audit’s veracity. See blog.

In addition to finding that additional claims satisfied Medicare coverage & payment requirements, the ALJ also found that OIG’s statistical extrapolation process did not comply with § 1893 of the Social Security Act, nor with the MPIM’s guidance on statistical extrapolation.

The ALJ held that HHS policy requires that the OIG’s audit must be able to be recreated and that as the audit’s sampling frame utilized data from outside of the audit, the audit could not be recreated.

The Council subsequently reviewed the ALJ’s decision on its own motion and reversed that decision in part, finding that the ALJ’s determination that the sampling process was invalid was an error of law. The Council then concluded that the OIG contractor’s statistical extrapolation met all applicable Medicare legal and regulatory requirements. 

The hospital appealed to the federal district court. The district court’s review consists of determining whether, in light of the record as a whole, the Secretary’s determination is supported by “substantial evidence.”

According to the Court, the hospital amply demonstrated that the Council did not have the authority to overturn the decision of the ALJ on own-motion review. Accordingly, the hospital’s Motion for Summary Judgement was GRANTED and the extrapolation was thrown out.