Category Archives: Provider Appeals of Adverse Decisions for Medicare and Medicaid

Premature Recoupment of Medicare Reimbursements Defies Due Process!

Who knows that – regardless your innocence –the government can and will recoup your funds preemptively at the third level of Medicare appeals. This flies in the face of the elements of due process. However, courts have ruled that the redetermination and the reconsideration levels afford the providers enough due process, which entails notice and an opportunity to be heard. I am here to tell you – that is horse manure. The first two levels of a Medicare appeal are hoops to jump through in order to get to an independent tribunal – the administrative law judge (“ALJ”). The odds of winning at the 1st or 2nd level Medicare appeal is next to zilch, although often you can get the alleged amount reduced. The first level is before the same entity that found you owe the money. Auditors are normally not keen on overturning themselves. The second level is little better. The first time that you present to an independent tribunal is at the third level.

Between 2009 and 2014, the number of ALJ appeals increased more than 1,200 percent. And the government recoups all alleged overpayments before you ever get before an ALJ.

In a recent case, Sahara Health Care, Inc. v. Azar, 975 F.3d 523 (5th Cir. 2020), a home health care provider brought an action against Secretary of Department of Health and Human Services (“HHS”) and Administrator for the Centers for Medicare and Medicaid Services (“CMS”), asserting that its statutory and due process rights were violated and that defendants acted ultra vires by recouping approximately $2.4 million in Medicare overpayments without providing a timely ALJ hearing. HHS moved to dismiss, and the provider moved to amend, for a temporary restraining order (“TRO”) and preliminary injunction, and for an expedited hearing.

The case was thrown out, concluding that adequate process had been provided and that defendants had not exceeded statutory authority, and denied provider’s motion for injunctive relief and to amend. The provider appealed and lost again.

What’s the law?

Congress prohibited HHS from recouping payments during the first two stages of administrative review. 42 U.S.C. § 1395ff(f)(2)(A).

If repayment of an overpayment would constitute an “extreme hardship, as determined by the Secretary,” the agency “shall enter into a plan with the provider” for repayment “over a period of at least 60 months but … not longer than 5 years.” 42 U.S.C. § 1395ddd(f)(1)(A). That hardship safety valve has some exceptions that work against insolvent providers. If “the Secretary has reason to believe that the provider of services or supplier may file for bankruptcy or otherwise cease to do business or discontinue participation” in the Medicare program, then the extended repayment plan is off the table. 42 U.S.C. § 1395ddd(f)(1)(C)(i). A provider that ultimately succeeds in overturning an overpayment determination receives the wrongfully recouped payments with interest. 42 U.S.C. § 1395ddd(f)(2)(B). The government’s interest rate is high. If you do have to pay back the alleged overpayment prematurely, the silver lining is that you may receive extra money for your troubles.

The years-long back log, however, may dwindle. The agency has received a funding increase, and currently expects to clear the backlog by 2022. In fact, the Secretary is under a Mandamus Order requiring such a timetable. 

A caveat regarding this grim news. This was in the Fifth Circuit. Other Courts disagree. The Fourth Circuit has held that providers do have property interests in Medicare reimbursements owed for services rendered, which is the correct holding. Of course, you have a property interest in your own money. An allegation of wrongdoing does not erase that property interest. The Fourth Circuit agrees with me.

HIPAA and Football

By Ashley Thomson, Partner at Practus, LLP. A Virtual Law Firm.

On rare occasions a Court can issue an opinion that is so logical and on-point you want to stand up and cheer.  Maybe you’re only cheering if you’re a HIPAA-nerd, like me. My name is Ashley and I work with Knicole. I was the assistant GC for Truman Medical Center for 17 years. As AGC at Truman, I was inundated with so many various issues.

Here’s what got me standing up in my home office as if Patrick Mahomes just threw a pass to Tyreek Hill and the KC Chiefs scored the winning touchdown in the Super Bowl—the 5th Circuit Court of Appeals held that a lost or stolen unencrypted device containing protected health information (“PHI”)[1] does not automatically result in a violation of the HIPAA Disclosure Rule or Encryption Rule. If you want to do your own touchdown dance check out Univ. of Texas M.D. Anderson Cancer Ctr. v. United States Dep’t of Health & Human Servs., No. 19-60226, 2021 WL 127819, at *5 (5th Cir. Jan. 14, 2021).

Unless you’ve spent the last 20 years living under a rock, you are generally aware that HIPAA is a law that protects your health information from public disclosure.  Most people don’t spell it correctly and even less people know what the acronym means.[2]  In 2009, HIPAA was supplemented with the HITECH Act.[3] Together, these laws govern how health care providers handle your medical information and what to do if there is a breach of the information.  HIPAA and HITECH’s implementing regulations (the “Regulations”) require all covered entities[4] “implement a mechanism to encrypt” all PHI that is stored electronically.  45 C.F.R. Section 164.312(a)(2)(iv).  Second, the Regulations prohibit unpermitted disclosure of PHI. 45 C.F.R. Sec. 164.502(a). These two regulations are referred to as the Encryption Rule and the Disclosure Rule respectively. These requirements are enforced by the Department of Health and Human Services (“HHS”) in conjunction with the Office for Civil Rights (“OCR”).

Whew, that was a quick history lesson.  Now, back to the story.

In 2012 and 2013 MD Anderson Cancer Center (“MD Anderson”) had three (3) events happen involving unencrypted devices containing PHI.  First, a laptop was stolen.  Second, a thumb drive was lost during someone’s commute home. Third, a visiting researcher misplaced a thumb drive. Pursuant to the regulations, MD Anderson reported these events to HHS.  

HHS concluded that MD Anderson violated the Regulations and imposed a fine over $4,000,000 (let me spell that out for you. . . FOUR MILLION DOLLARS). 

You may be wondering, what in the world did they violate that would result in such an outrageous fine?  So did MD Anderson!

MD Anderson threw its proverbial, red challenge flag and pursued its appeal rights and ended up, finally, in Federal Court where they succeeded on establishing that the mere loss of unencrypted PHI does not violate the Disclosure Rule and that the Encryption Rule does not require that a covered entity sit down and force each and every person to encrypt their devices.

Let’s look first at the Disclosure Rule. As a general rule, HIPAA prohibits the disclosure of PHI without permission from the patient.[5]  45 C.F.R. Sec. 164.502(a). HIPAA defines disclosure as “the release, transfer, provision of access to, or divulging in any manner of information outside the entity holding the information.” 45 C.F.R. Sec. 164.103. Prior to reaching the 5th Circuit, MD Anderson had been told the mere fact that the unencrypted laptop and thumb drives were lost or stolen resulted in the conclusion the PHI had been improperly disclosed to someone outside of the covered entity.  Thank goodness, the Court stepped in with the reasonable statement that many of us in the health care field have been saying for years. . . just because a device is lost or stolen doesn’t mean the PHI was improperly disclosed.[6]  “It defies reason to say an entity affirmatively acts to disclose information when someone steals it.” Univ. of Texas M.D. Anderson Cancer Ctr.,2021 WL 127819, at *5.

HHS claimed that it would be difficult for them to enforce the Disclosure Rule if it had to show that the PHI was disclosed to someone outside of the covered entity.  Well, go complain to the referees  HHS “that’s precisely the sort of policy argument that HHS could vet in a rulemaking proceeding. It’s not an acceptable basis for urging us to transmogrify the regulation HHS wrote into a broader one.” Id. And with that, the Court unceremoniously stated the obvious and provided some reason in the rather unreasonable world of HIPAA enforcement.

Next up? The Encryption Rule where HHS argued that MD Anderson’s desire to do more to encrypt their devices was an admission of non-compliance with the regulations.  Not so fast, said the Court.  The rule requires that a covered entity have a mechanism for the encryption PHI not that it implements an iron clad, hacker proof, 100% guaranteed encryption system.  MD Anderson had an encryption mechanism which is enough to satisfy the regulation, even if HHS now “wishes it had written a different” regulation.  Id.at *4.  

I feel like this is the SUPERBOWL of HIPAA decisions. You may not be as excited about this opinion as I was.  That’s ok. . . I’m a HIPAA and privacy nerd and I’m ok with that.  

Let’s hope I have many touchdowns to stand up and celebrate on Sunday!  Go Chiefs!    

The legal fine print: As exciting as this opinion is, please  remember that devices should be encrypted and PHI should be protected to the maximum extent possible.  While this is a great decision, it doesn’t remove the obligation to comply with the Regulations. 


[1] PHI contains 18 different identifiers.  42 C.F.R. § 164.514(a)(2)(i).

[2] It’s the Health Insurance Portability and Accountability Act of 1996. 

[3] HITECH stands for the Health Information Technology for Economic and Clinical Health Act of 2009. 

[4] Later, we can delve into what qualifies as a covered entity. Let’s just all agree that MD Anderson is a covered entity.

[5] This is a very simple overstatement, but it works for the purposes of this article.

[6] Let’s face it, most of these devices are lost or stolen and (1) never found or (2) thrown out as the thieves take what they really wanted . . . cold hard cash or credit cards.  An old janky laptop or a random thumb drive is not at the top of the most wanted list for kleptomaniacs.

Medicaid Suspension Lifted Because No Evidence of Intent!

Happy 2021! I bring great news and good tidings. I’m fairly sure that everyone reading is educated in what a preliminary injunction is and how important it can be for a health care provider falsely accused of credible allegations of fraud to lift the mandatory suspension of reimbursements. Finally, over the holidays, a Judge found that an indication of intent is required for an accusation of credible allegations of fraud, unlike past cases in which a mere accusation results in suspensions. 42 CFR §455.23 mandates that a health care provider’s reimbursements be suspended based on “credible allegations of fraud.” Which is a low bar. My client, an oral surgeon, had a disgruntled employee complaint and a baseless PCG audit of $6k. A double threat.

For those who are not in the know: An injunction is an extraordinary legal tool that allows the judge to suspend whatever bad action the government or one of its auditors do.

You have to prove:

  1. Likelihood of success on the merits
  2. Irreparable harm
  3. Balance of equities
  4. Public Interest.

I would guestimate that only 10-20% of requests for TROs and PIs are granted. Last week, we won for the oral surgeon. Everyone can learn from his success. This is how we won. Let me set the stage. We have an oral surgeon who underwent an infamous PCG audit resulting in an alleged $6k overpayment. PCG concurrently sends his data to program integrity, and one month later and without any notice, his reimbursements are suspended based on a “credible allegation of fraud.” Concurrently, he had a disgruntled employee threatening him.

Remember that the bar to demonstrate “credible allegation of fraud” is amazingly low. It is an “indicia of reliability.” An inaccurate PCG audit and a disgruntled employee, in this case, were the catalyst for the oral surgeon’s Medicaid reimbursements. His practice comprised of 80% Medicaid, so the suspension would cause irreparable harm to the practice.

We filed a TRO, PI, and Motion to Stay. The day before Christmas, we had trial.

The Judge ruled that the Department cannot just blindly rely on an anonymous accusation. There has to be some sort of investigation. It is not OK to accept accusations at face value without any sort of independent fact-checking. The Judge created an additional burden for the Department in cases of accusations of fraud that is not present in the regulation. But it is logical and reasonable to expect the Department to explore the accusations. The Judge emphasized that fraud requires intent. He also pointed out that fraud is not defined in the regulations. He emphasized that billing errors are not intentional acts.

The Judge held that, “[i]n light of the large number of Medicaid beneficiaries treated by the Petitioner’s practice, the rarity of the physician’s skills, and the apparent demand for those services, the relatively small amount of money now or formally in controversy, the lack of evidence of actual fraud and the contrary indications, the high probability that good cause exists for not suspending Petitioner’s Medicaid payments, and the near certainty of irreparable harm to the Petitioner if the relief is not granted, a TRO should be granted.”

Even better, the Judge ordered that the surgeon did not have to put up a bond, which is normally required by law. By the stroke of the Judge’s pen, the surgeon could go back to work performing medically necessary services to Medicaid recipients, which, by the way is rare for an oral surgeon to accept Medicaid. This is a success for health care providers. Accusations of fraud should require independent corroboration and evidence of intent.

KNICOLE EMANUEL TO HOST JANUARY WEBCAST ON PRFS AND RAC AUDITS

For healthcare providers looking to avoid any of the traps stemming from PRF (Provider Relief Funds) compliance, RACmonitor is inviting you to sign up for Knicole Emanuel’s upcoming webcast on January 21st, 2021. It is titled: COVID-19 Provider Relief Funds: How to Avoid Audits.  You can visit RACmonitor download the order form for the webcast to save yourself a spot. 

Webcast Description: 

If your facility accepted Provider Relief Funds (PRFs) as a consequence of the coronavirus pandemic, you need to be aware of the myriad of rules and regulations that are associated with this funding or else face penalties and takebacks. A word of caution: expect to be audited. In Medicare and Medicaid, regulatory audits are as certain as death and taxes. That is why your facility needs to arm itself with the knowledge of how to address documentation requests from the government, especially while the Public Health Emergency (PHE) is in effect.

This exclusive RACmonitor webcast, led by healthcare attorney Knicole Emanuel, discusses the PRF rules that providers must follow and how to prove that funds were appropriately used. There are strict regulations dictating why, how, and how much PRFs can be spent due to the catastrophic, financial impact of COVID-19. Register now to learn how to avoid penalties and takebacks related to PRFs.

Learning Objectives:

  • Rules and regulations relative to receiving and spending funds provided by the COVID-19 PRF
  • Exceptions to COVID-19 PRF and relevant effective dates
  • PRF documentation and reporting requirements
  • The importance of the legal dates of PHE
  • How to prove your facility’s use of funds is germane to COVID-19

Who Should Attend:

  • CFOs
  • RAC and appeals specialists
  • RAC coordinators
  • Compliance officers
  • Directors and managers

About Knicole C. Emanuel, Esq.

Healthcare industry expert and Practus partner, Knicole Emanuel, is a regular contributor to the healthcare industry podcast, Monitor Mondays, by RACmonitor. For more than 20 years, Knicole Emanuel has maintained a health care litigation practice, concentrating on Medicare and Medicaid litigation, health care regulatory compliance, administrative law and regulatory law. Knicole has tried over 2,000 administrative cases in over 30 states and has appeared before multiple states’ medical boards. 

She has successfully obtained federal injunctions in numerous states. This allowed health care providers to remain in business despite the state or federal laws allegations of health care fraud, abhorrent billings, and data mining. A wealth of knowledge in her industry, Knicole frequently lectures across the country on health care law. This includes the impact of the Affordable Care Act and regulatory compliance for providers, including physicians, home health and hospice, dentists, chiropractors, hospitals and durable medical equipment providers.

Goodbye, 2020: New Resolutions for Health Care Providers

By Ashley Thomson. (Knicole Emanuel‘s law partner. See below for a bio).

As 2020 ends and we look forward to starting a new chapter in 2021, we offer you this little nugget of advice—a resolution that sounds deceptively easy—read your mail.  Yes, friends you heard it here first. . . the best thing you can do to protect yourself, your business, your patients, and your loved ones is to read the dang mail.  Email, text messages, real mail, carrier pigeon or messages in a bottle.  READ THEM!  

2020 brought us a lot of curve balls and unexpected events but some of those events could have been avoided had mail been opened and read.

CMS and its third party contractors hold a lot of power in the healthcare world and can cause your practice to come crashing down by hitting send or putting a forever stamp on a letter.  A regular practice of reading your mail can avoid that CMS avalanche of doom. [1]

You may be reading this and thinking, you’ve got to be crazy I always read my mail.  Or perhaps you are thinking, this is the easiest new year’s resolution yet—all I have to do is read the mail.

Don’t be too hasty with your self-confidence. This is a hard practice to establish and an even harder one to maintain.

First, you have to actually read the mail.  All of the mail.  Even the mail you think will contain bad news.  Constitutional due process requires only notice NOT successful notice. If successful notice were required, “then people could evade knowledge, and avoid responsibility for their conduct, by burning notices on receipt—or just leaving them unopened.” See Ho v. Donovan, 569 F.3d 677, 680 (7th Cir. 2009). “Conscious avoidance of information is a form of knowledge.” Id.

Second, you need a policy or procedure regarding the opening and reading of mail.  One client we worked with did not have a system for logging mail once it was received in the office.  Mail was lost.  Deadlines were missed.  Payments from the largest payer were suspended. The cost – too much to print.

It’s like that old Mastercard ad, yes, I’m talking to those of you out there who were around in the late 90s.[2] 

The cost of establishing a policy for logging in mail. . . zero.   

The cost of reading mail. . . zero.

The cost of neglecting your mail, missing deadlines, and losing your practice. . . priceless.

So, as this year ends and you contemplate ways to improve your practice in 2021, please, please, please take our advice and READ YOUR MAIL.


[1]It’s not just CMS that has holds the mailbox power.  Just ask the City of North Charleston, SC.  A motorist’s emailed complaint to the city over injuries sustained in an accident was not forwarded to the insurance carrier resulting in a multi-million dollar default judgement against the city.  See Campbell v. City of North Charleston, 431 S.C. 454,459 (SC Ct. App. 2020) (holding that “the failure to forward an email did not amount to good cause shown for failure to timely file an answer).   

[2] For those of you who have no idea what we are talking about see https://www.aaaa.org/timeline-event/mastercard-mccann-erickson-campaign-never-got-old-priceless/  

Click for past blogs with other helpful tips to avoid Medicare and Medicaid recoupments. medicaidlaw-nc.wordpress.com – Tip #2. 4. 6.

Ashley Thomson brings 20 years of extensive in-house, hospital counsel and law firm experience to our team.  Well-versed in a variety of disciplines, her emphasis is in health care, insurance and compliance, specifically medical malpractice, employment, healthcare and privacy law compliance and defense, including matters involving HIPAA. Ashley has also been heavily involved in risk management, patient safety, corporate governance, contract and policy drafting, negotiations and healthcare management. Prior to joining Practus, Ashley served as Associate General Counsel for Truman Medical Center (TMC) where she oversaw litigation, managed all aspects of their corporate compliance matters, including governmental audits and investigations, cybersecurity issues, HIPAA enforcement, 340B compliance and provider-based billing.  As their Staff Litigation Counsel, she defended and litigated medical malpractice and general liability matters on behalf of the hospital, its employees, physician group and residents. Prior to joining TMC, Ashley was an Associate Attorney for Husch Blackwell.

Ashley is an outdoors woman at heart. When she’s not working, she’s hiking, walking, working in her yard, or playing with her kids. She’s also an avid reader and a football fan especially when she’s watching her favorite team, the Kansas City Chiefs! 

“Credible Allegations of Fraud”: Immediate Medicare Payment Suspension!

If you are accused of Medicare fraud, your Medicare reimbursements will be immediately cut off without any due process or ability to defend yourself against the allegations. If you accept Medicare and Medicaid then you are held to strict regulations, some of which are highly, Draconian in nature without much recourse, legally, for providers. Many, many a provider have gone bankrupt and been forced out of business due to “credible allegations of fraud.” You see, legally, “credible allegations of fraud” is a low standard to meet. The definition of “credible” is “an indicia of reliability.” “Indicia” is defined as “signs, indications, circumstances which tend to show or indicate that something is probable. It is used in the form of “indicia of title,” or “indicia of partnership,” particularly when the “signs” are items like letters, certificates, or other things that one would not have unless the facts were as the possessor claimed. It can be a disgruntled worker. I am sure that none of the listeners here today have ever dealt with a disgruntled employee. Yes, that is sarcasm.

42 CFR § 405.372 is the regulation outlining the requirements for suspending Medicare payments. 42 CFR § 455.23 is the regulation mandating suspension of Medicaid payments upon credible allegations of fraud.

Pursuant to Medicare regulations, CMS must suspend Medicare reimbursements to a healthcare provider “in whole or in part” if it has been “determined that a credible allegation of fraud exists against a provider or supplier.” 42 C.F.R. § 405.371(a)(2). A credible allegation of fraud is “an allegation from any source, including … civil fraud claims cases, and law enforcement investigations.” 42 C.F.R. § 405.370(a). The decision to suspend Medicare payment or continue a payment suspension is made at the discretion of CMS – not the MAC. If you receive a letter from a MAC alleging fraud, be sure to check whether the letter states that the decision was made in collaboration with CMS. The MACs do not have the authority.

The suspension, however, is not indefinite, although the length is normally a year, which is financially devastating. The regulations allow CMS to maintain the suspension until a “legal action is terminated by settlement, judgment, or dismissal, or when the case is closed or dropped because of insufficient evidence to support allegations of fraud.” 42 C.F.R. §§ 405.370(a) and .372(d)(3); see also § 405.371(b)(3)(ii) (CMS may extend the suspension of payment if the Department of Justice submits a written request that “suspension of payments be continued based on the ongoing investigation and anticipated filing of criminal or civil action or both or based on a pending criminal or civil action or both.”).

When you receive a fraud accusation of any type – it is imperative to send it to your counsel. If you opt to litigate the suspension by asking the Court to enjoin the suspension, your first legal obstacle will be to argue that you do not have to exhaust your administrative remedies before appearing for the injunction. Cases have been decided both in the favor of providers and their suspensions have been lifted and against the providers. These cases usually win or lose on the argument that the suspension of reimbursements is an ancillary subject from the actual investigation of fraud. It is a jurisdictional argument.

It is my opinion that the federal regulations that allow for suspension of payments upon credible allegations of fraud need to be revised. Any of you with lobbyists, we need to revise the regulations to require due process – notice and an opportunity to be heard – prior to the government suspending Medicare and Medicaid reimbursements based on a spurious accusation from an anonymous source.

Back in 2015, I am sure that you all recall the case in New Mexico where NM accused 15 BH care provider of credible allegations of fraud. The providers constituted 87.5% of the BH in NM. I was one of the attorneys representing the larger BH cos. Prior to my involvement, all 15 providers requested good cause. All were denied. Lawmakers think that the good cause exception written into the regulation is enough defense for providers. But when the good cause is almost always denied, it isn’t much help. Write to your congress people. Amend the regulations to require due process.

The Undefined, Definition of “Medical Necessity”

While the Coronavirus pandemic is horrible and seems to be getting worse. COVID has forced slight, positive changes in the telehealth arena and, perhaps, in the widening of the ambiguous definition of “medical necessity” or, as I call it – the undefined, definition of “medical necessity.” Medical necessity is the backbone of rendering health care services. Without it, services should not be provided. Yet, medical necessity is the most litigated topic in all of audits.

On September 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule that will codify a definition of “medical necessity” for Medicare purposes. So far, the definition of medical necessity varies, depending on the source. The MACs have been given long rein in defining the term on an individual and separate basis, creating disparity in definitions and criteria. The proposed rule’s comment period ended November 2, 2020.

All this to say medical necessity is in the eye of the beholder. Much like beauty. Why then, can RAC and MAC auditors who are not doctors, not firsthand, treating providers, not nurses or LCASs, decide that medical necessity does or does not exist for a patient that they have never seen?

Black’s Law Dictionary (the most prominent legal dictionary) has a super, unhelpful definition of medical necessity: “If not carried out the patient’s situation could worsen. For a patient’s treatment found to be necessary is this specific type of procedure or treatment.”

The American Medical Association (“AMA”), on the other hand, has a more detailed definition, probably unintended to make it all the more confusing:

“Our AMA defines medical necessity as: Health care services or products that a prudent physician would provide to a patient for the purpose of preventing, diagnosing or treating an illness, injury, disease or its symptoms in a manner that is: (a) in accordance with generally accepted standards of medical practice; (b) clinically appropriate in terms of type, frequency, extent, site, and duration; and (c) not primarily for the economic benefit of the health plans and purchasers or for the convenience of the patient, treating physician, or other health care provider.”

CMS’ proposed rule codifies a definition of what makes an item or service medically “reasonable and necessary” under the Social Security Act 1861(a)(1)(A). The rule, if finalized, would codify in regulations a definition of “reasonable and necessary” items and services based on a definition currently used by Medicare Administrative Contractors (MACs), with an additional element that potentially would include coverage determinations by commercial insurers as a factor in making Medicare coverage determinations.

The Proposed Definition (To be Codified in 42 CFR 405.201)

“We are proposing to codify the longstanding Program Integrity Manual definition of “reasonable and necessary” into our regulations at 42 CFR 405.201(b), with modification. Under the current definition, an item or service is considered “reasonable and necessary” if it is (1) safe and effective; (2) not experimental or investigational; and (3) appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is—

  • Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;
  • Furnished in a setting appropriate to the patient’s medical needs and condition;
  • Ordered and furnished by qualified personnel;
  • One that meets, but does not exceed, the patient’s medical need; and
  • At least as beneficial as an existing and available medically appropriate alternative.” See Proposed Rule.

In addition, CMS adds that it will also utilize commercial payor standards or have an objective panel determine medical necessity if criteria #1 and #2 were met, but not #3. This additional commentary is another example of how subjective and fact-specific determining medical necessity can be. The LCDs will also be consulted.

If adopted, these proposals would arguably lead to the most wide-ranging changes in Medicare’s coverage standards and procedures in decades. The proposal to codify the definition of “reasonable and necessary” applies to all items and services. The inclusion of commercial payor standards may be a wild card.

The definition of medical necessity has not been officially revised – yet. One could imagine that, in the midst of a RAC or MAC audit, auditors and providers will disagree as to the true definition of medical necessity.

Going forward, when you get audited, immediately look and see whether your claim denials were denied due to “lack of medical necessity.” Ask yourself, “Really? Is there no medical necessity in this case…even in the era of COVID?” Because the auditors may be wrong.

Secondly, ensure that the RAC and MAC entity is CMS-certified to review those certain CPT codes for medical necessity. CMS limits audits on medical necessity because of the vagueness of the definition. When auditors find no medical necessity, then providers must push back. And you should push back, legally, of course!

Fairness in Medicare: Post Payment Review in the Courts of Equity

As children, we say things are or are not fair. But what is fair? In law, fairness is “tried” in the courts of equity rather than law. Equitable estoppel and the defense of laches are arguments made in the courts of equity. Is it fair if you’ve been billing Medicare for services that you were told by CMS was billable and reimburse-able – for years – then, unexpectantly, CMS says, “Hey, providers, what you were told was reimburse-able, actually is not. In fact, providers, even though you relied on our own guidance, we will cease and desist from paying you going forward AND…we are now going back three years to retroactively collect the money that we should never have paid you…”

How is this fair? Yet, many of you have probably encountered RAC or MAC audits and a post payment review. What I described is a post payment review. Let me give you an example of a nationwide, claw-back by CMS to providers.

On January 29, 2020, CMS announced that beginning March 1, 2020, MACs will reject claims for HCPCS code L8679 submitted without an appropriate HCPCS/CPT surgical procedure code. Claims for HCPCS code L8679 billed with an appropriate HCPCS/CPT surgical code will be suspended for medical review to verify that coverage, coding, and billing rules have been met.

At least according to the announcement, it sounded like CMS instructed the MACs to stop reimbursing L8679 going forward, but I read nothing about going back in time to recoup.

In the last few months, my team has been approached by chiropractors and holistic medical providers who received correspondence from a UPIC and their MACs that they owe hundreds of thousands of dollars for L8679 going back three years prior to CMS’ 2020 announcement to cease using the code.

In this particular instance, many of the providers who had been using the L8679 code did so under the direct guidance of CMS, MACs, and other agents over the years. It becomes a fairness question. Should CMS be able to recoup for claims paid for services rendered when CMS had informed the providers it was the correct code for years?

Another factor to consider is that many of these providers are victims of an intentional scheme to sell devices with the false advice that the devices are covered by Medicare. Litigation has already been filed against the company. In a case filed December 6, 2019, in US District Court of the Eastern District of PA, Neurosurgical Care LLC sued Mark Kaiser and his current company, Doc Solutions LLC, claiming that Kaiser’s company falsely marketed the device as being covered by Medicare. Stivax is a “non-narcotic and minimally invasive form of neurostimulation” which is represented as “one of the only FDA approved microchip controlled microstimulation devices for treating back, joint and arthritic pain.”

Recall that, over the years, CMS paid for these approved procedures with no problem. This situation begins to leave the realm of the courts of law and into the court of equity. It becomes an equitable issue. Is there fairness in Medicare?

There may not be fairness, but there is an administrative appeal process for health care providers! Use it! Request redeterminations!

RAC Audits Expected During the COVID Pandemic

Even though the public health emergency (“PHE”) for the COVID pandemic is scheduled to expire July 24, 2020, all evidence indicates that the PHE will be renewed. I cannot imagine a scenario in which the PHE is not extended, especially with the sudden uptick of COVID.

Center for Medicare and Medicaid Services (CMS) has given guidance that the voluminous number of exceptions that CMS has granted during this period of the PHE may be extended to Dec. 1, 2020. However, there is no indication of the RAC, and MAC audits being suspended until December 2020. In fact, we expect the audits to begin again any day. There will be confusion when audits resume and COVID exceptions are revoked on a rolling basis.

Remember the emergency-room physician whom I spoke about on the June 29 on Monitor Mondays? The physician whose Medicare enrollment was revoked due to a computer error or an error on the part of CMS. What normally would have been an easy fix, because of COVID, became more difficult. Because of COVID, he was unable to work for three months. He is back up and running now. The point is that COVID really messed up so many aspects of our lives.

The extension of PHE, technically, has no bearing on RAC and MAC audits coming back. Word on the street is that RAC and MAC audits are returning August 2020.

This month, July 2020, CMS released, “Coronavirus Disease 2019 (COVID-19) Provider Burden Relief Frequently Asked Questions (FAQs).” (herein afterward referred as “CMS July 2020 FAQs”).

The question was posed to CMS: “Is CMS suspending most Medicare-Fee-for-Service (FFS) medical review during the PHE for the COVID-19 pandemic? The answer is, according to CMS, “As states reopen, and given the importance of medical review activities to CMS’ program integrity efforts, CMS expects to discontinue exercising enforcement discretion beginning on Aug. 3, 2020, regardless of the status of the public health emergency. If selected for review, providers should discuss with their contractor any COVID-19-related hardships they are experiencing that could affect audit response timeliness. CMS notes that all reviews will be conducted in accordance with statutory and regulatory provisions, as well as related billing and coding requirements. Waivers and flexibilities in place at the time of the dates of service of any claims potentially selected for review will also be applied.” See CMS July 2020 FAQs.

Monday, July 13, 2020, we began our fourth “COVID-virtual trial.” The Judges with whom I have had interaction have taken a hard stance to not “force” someone to appear in person. It appears, at least to me, that virtual trials are the wave of the future. This is the guidance that conveys to me that RAC and MAC audits will begin again in August. Virtual audits may even be the best thing that ever happened to RAC and MAC audits. Maybe now the auditors will actually read the documents that the provider gives them.

Another specific issue addressed in the CMS’ July 2020 FAQs is that given the nature of the pandemic and the inability to collect signatures during this time, CMS will not be enforcing the signature requirement. Typically, Part B drugs and certain Durable Medical Equipment (DME) covered by Medicare require proof of delivery and/or a beneficiary’s signature. Suppliers should document in the medical record the appropriate date of delivery and that a signature was not able to be obtained because of COVID-19. This exception may or may not extend until Dec. 31, 2020.

The upshot is that no one really knows how the next few months will unfold in the healthcare industry. Some hospitals and healthcare systems are going under due to COVID. Big and small hospital systems are in financial despair. A RAC or MAC audit hitting in the wake of the COVID pandemic could cripple most providers. I will reiterate my recommendation: In the re-arranged words of Roosevelt, “Speak loudly, and carry a big stick.”

Programming Note: Knicole Emanuel is a permanent panelist on Monitor Mondays. Listen to her live reporting every Monday at 10 a.m. EST.

PHE Is an Enigma for Most Providers

As of now, the public health emergency (PHE) for the COVID-19 pandemic will expire July 24, 2020, unless it is renewed. Fellow contributor David Glaser and I have both reported on the potential end date of the PHE. Recent intel from Dr. Ronald Hirsh is that the Centers for Medicare & Medicaid Services (CMS) may renew the PHE period. Each time the PHE period is renewed, it is effective for another 90 days. Recent news about the uptick in COVID cases may have already alerted you that the PHE period will probably be prolonged.

CMS has given guidance that the exceptions that it has granted during this period of the PHE may be extended to Dec. 1, 2020. There is no indication of the Recovery Audit Contractor (RAC) and Medicare Administrative Contractor (MAC) audits being suspended until December 2020. In fact, we expect the audits to begin again any day. There will be confusion when audits resume and COVID exceptions are revoked on a rolling basis.

I witnessed some interesting developments as a health care attorney during this ongoing pandemic. Three of my physician clients were erroneously placed on the Medicare exclusion lists. One would think that during the pandemic, CMS would move mountains to allow a Harvard-trained ER doctor to work in an ER. Because of the lack of staff, it was actually difficult to achieve an easy fix. This doctor was suspended from Medicare based on an accidental and inadvertent omission of a substance abuse issue more than 10 years ago. He disclosed everything except an 11-year-old misdemeanor. He did not omit the misdemeanor purposely. Instead, this ER physician relies on other hospital staff to submit his Medicare re-credentialing every year, as he should. It just happened that this year, the year of COVID, this doctor got caught up in a mistake that in normal times would have been a phone call away from fixing. We cleared up his issue, but not until he was unable to work for over two months, during the midst of the PHE.

At the time of the announcement of the public health emergency, another company, a home health provider, was placed on prepayment review. I am not sure how many of you are familiar with prepayment review, but this is a Draconian measure that all States and the federal government may wield against health care providers. When you are on prepayment review, you cannot get paid until another independent contracted entity reviews your claims “objectively.” I say objectively in quotes because I have yet to meet a prepayment review audit with which I agreed.

Mostly because of COVID, we were forced to argue for a preliminary injunction, allowing this home heath provider to continue to provide services and get paid for services rendered during the PHE. We were successful. That was our first lawsuit during COVID. I believe we went to trial in April 2020. We had another trial in May 2020, for which we have not received the result, although we have high hopes. I may be able to let you know the outcome eventually. But for now, because of COVID, with a shortage of court reporters willing to work, we will not receive the transcript from the trial until over four weeks after the trial.

Tomorrow, Tuesday, we begin our third COVID trial. For the first time since COVID, it will not be virtual. This is the guidance that conveys to me that RAC and MAC audits will begin again soon. If a civil judge is ordering the parties to appear in person, then the COVID stay-at-home orders must be decreasing. I cannot say I am happy about this most recent development (although audits may be easier if they are conducted virtually).

The upshot is that no one really knows how the next few months will unfold in the healthcare industry. Some hospitals and healthcare systems are going under due to COVID. Big and small hospital systems are in financial despair. A RAC or MAC audit hitting in the wake of the COVID pandemic could cripple most providers. In the rearranged words of Roosevelt, “speak loudly, and carry a big stick.”