Monthly Archives: May 2022

CMS Rulings Can Devastate a Provider, But Should It?

If you could light a torch to a Molotov Cocktail and a bunch of newspapers, you could not make a bigger explosion in my head than a recent Decision from a Medicare administrative law judge (“ALJ”). The extrapolation was upheld, despite an expert statistician citing its shortcomings, based on a CMS Ruling, which is neither law nor precedent. The Decision reminded me of the new Firestarter movie because everything is up in flames. Drew Barrymore would be proud.

I find it very lazy of the government to rely on sampling and extrapolations, especially in light that no witness testifies to its accuracy.

Because this ALJ relied so heavily on CMS Rulings, I wanted to do a little detective work as to whether CMS Rulings are binding or even law. First, I logged onto Westlaw to search for “CMS Ruling” in any case in any jurisdiction in America. Nothing. Not one case ever mentioned “CMS Ruling.” Ever. (Nor did my law school).

What Is a CMS Ruling?

A CMS Ruling is defined as, “decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous provisions of the law or regulations relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters.”

But Are CMS Rulings Law?

No. CMS Rulings are not law. CMS Rulings are not binding on district court judges because district court judges are not part of HHS or CMS. However, the Medicare ALJs are considered part of HHS and CMS; thus the CMS Rulings are binding on Medicare ALJs.

This creates a dichotomy between the “real law” and agency rules. When you read CMS Ruling 86-1, it reads as if there two parties with oppositive views, both presented their arguments, and the Administrator makes a ruling. But the Administrator is not a Judge, but the Ruling reads like a court case. CMS Rulings are not binding on:

  1. The Supreme Court
  2. Appellate Courts
  3. The real world outside of CMS
  4. District Courts
  5. The Department of Transportation
  6. Civil Jurisprudence
  7. The Department of Education
  8. Etc. – You get the point.

So why are Medicare providers held subject to penalties based on CMS Rulings, when after the providers appeal their case to district court, that “rule” that was subjected against them (saying they owe $7 million) is rendered moot? Can we say – not fair, equitable, Constitutional, and flies in the face of due process?

The future does not look bright for providers going forward in defending overzealous, erroneous, and misplaced audits. These audits aren’t even backed up by witnesses – seriously, at the ALJ Medicare appeals, there is no statistician testifying to verify the results. Yet some of the ALJs are still upholding these audits.

In the “court case,” which resulted in CMS Ruling 86-1, the provider argued that:

  1. There is no legal authority in the Medicare statute or regulations for HCFA or its intermediaries to determine overpayments by projecting the findings of a sample of specific claims onto a universe of unspecified beneficiaries and claims.
  2. Section 1879 of the Social Security Act, 42 U.S.C. 1395pp, contemplates that medical necessity and custodial care coverage determinations will be made only by means of a case-by-case review.
  3. When sampling is used, providers are not able to bill individual beneficiaries not in the sample group for the services determined to be noncovered.
  4. Use of a sampling procedure violates the rights of providers to appeal adverse determinations.
  5. The use of sampling and extrapolation to determine overpayments deprives the provider of due process.

The CMS Ruling 86-1 was decided by Mr. Henry R. Desmarais, Acting Administrator, Health Care Financing Administration in 1986.

Think it should be upheld?

Medicare Investigations for False Claims Act Violations

Whenever you receive correspondence with letterhead from the Department of Justice, Attorney General’s office, you know it’s important and you better take note.

DOJ, AG

A Civil or Criminal Investigative Demand is serious. Getting any communication from the U.S. Department of Justice can be a bit unnerving. That’s particularly true for Medicare and Medicaid providers receiving a Civil Investigative Demand (“CID”) for documents and testimony.  

A CID is a tool used by the Justice Department (“DOJ”) to investigate potential violations of the False Claims Act (“FCA”). See blog. The DOJ can issue a CID whenever the DOJ has “reason to believe that any person may be in possession, custody, or control of any documentary material or information relevant to a false claims law investigation.” The bottom line is that the DOJ uses CIDs to obtain documents and identify potential witnesses so they can bring FCA suits against the recipient or others.

What is the False Claims Act anyway?

It’s a broad statute that punishes many things, one of which is making false statements to the government in connection with a claim for payment from the government. The DOJ often uses CIDs to investigate medical providers who seek payment from Medicare and Medicaid. 

Just because the Investigative Demand is labeled “civil” does not mean that the investigation is only civil; it could take a turn towards criminal. In other words, something sparked the DOJ’s attention, but, perhaps there were no allegations of criminal action, the investigation could start and the investigator could uncover something they consider criminal. An investigation earmarked as civil can turn criminal with the uncovering of one document.

On the other hand, the investigator could review all the documents and conclude that there is not even a civil violation. Very rarely, do the investigators contact you to tell you that the investigation is over and no violation was found. Most of the time, you are put on notice that you are being investigated, then hear nothing from the investigator in perpetuity.

Recently, I had an investigator inform me that the review of. my client was complete, and the file was being closed. But that’s the only time in 22 years that I was informed that nothing noncompliant was found. Usually, time just passes.

If you are found to have violated the FCA, the government can triple the amount of penalties, so the numbers get very high very quickly.

The Justice Department obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending Sept. 30, 2021. This is the second largest annual total in False Claims Act history, and the largest since 2014. Settlement and judgments since 1986, when Congress substantially strengthened the civil False Claims Act, now total more than $70 billion.

A much lesser known provision of the FCA is the reverse one. Not to blow everyones’ minds, but there is also a “reverse false claims” provision of the False Claims Act.  The reverse false claims provision permits the government or relators to pursue defendants who are alleged to have hidden or reduced an obligation to pay the government through false statements, or who have violated the 60-day payment rule’s obligation to return “identified overpayments.”   These claims typically have been raised in the context of cost reporting, Medicare Part C, or related to alleged failures to fulfill obligations under the 60-day payment rule.  The government and relators have increasingly relied on the reverse false claims provision to support stand-alone claims or have used it in conjunction with affirmative false claims.  However, because the reverse false claims provision is very lightly used compared to affirmative false claims provisions, there is a dearth of case law defining it or exploring its parameters.   The case law that does exist is primarily from district courts and, as the survey of case law contained herein illustrates, there is little guidance from the Circuit Courts or the U.S. Supreme Court.

Intent or deliberate disregard is required to prove the false claims act – reverse and regular.

Failure to respond to a CID completely could warrant criminal contempt. This is especially important to note, as civil investigate demand sounds much less important than a subpoena. But a CID is, in essence, a subpoena. Immediately, implement a “legal hold” upon receipt of the CID, and don’t forget to avoid producing privileged documents.

After the investigation is complete, if there are violations of the FCA uncovered, you will receive correspondence that states in “all-caps” and bold font:

Rule 408 FOR SETTLEMENT PURPOSES ONLY 

FRE 408 prohibits the use of settlement negotiations as evidence. After reviewing the offer, get with your legal counsel to discuss next steps.

DME Providers Get Repose in RAC Audits

The Centers for Medicare & Medicaid Services (CMS) announced that they have modified the additional documentation request (ADR) limits for the Medicare Fee-for-Service Recovery Audit Contractor (RAC) program for suppliers. ADRs are the about of documents that a RAC auditor can demand from you. This is a win for DME providers.

Currently, the RAC’s methodology is based on a total claim number by NPI without consideration for the number of claims in a particular product category. This means that suppliers can receive large volumes of RAC audits for a product category in which they do minimal business.

These new limits will be set by CMS on a regular basis to establish the maximum number of medical records that may be requested by a RAC, per 45-day period. These changes will be effective beginning April 1, 2022

Each limit will be based on a given supplier’s volume of Medicare claims paid within a previous 12-month period, in a particular HCPCS policy group (The policy groups are available on the PDAC website). Limits will be based on the supplier’s Tax Identification Number (TIN). Limits will be set at 10% of all paid claims, by policy group, paid within a previous 12-month period, divided into eight periods (45 days). If you get more than the allowed ADRs, call them out. These limits are created to lessen the burden on providers.

Although a RAC may go more than 45 days between record requests, in no case shall a RAC make requests more frequently than every 45 days. Limits are based on paid claims, irrespective of individual lines, although credit/replacement pairs shall be considered a single claim.

            For example:

  • Supplier A had 1,253 claims paid with HCPCS codes in the “surgical dressings” policy group, within a previous 12-month period. The supplier’s ADR limit would be (1,253 * 0.1) / 8 = 15.6625, or 16 ADRs, per 45 days, for claims with HCPCS codes in the “surgical dressings” policy group.
  • Supplier B had 955 claims paid with HCPCS codes in the “glucose monitor” policy group, within a previous 12-month period. The supplier’s ADR limit would be (955 * 0.1) / 8 = 11.9375 or 12 ADRs, per 45 days, for claims with HCPCS codes in the “glucose monitor” policy group.

CMS reserves the right to give a RAC permission to exceed these ADR limits. But that would be in instances of potential fraud.

Medicare Providers: Are Your Claims Clean?

The federal regulations mandate that 90% of “clean claims” must be paid to the providers by 30-days. 42 CFR § 447.45. But, what if (the payor) doesn’t pay within 30-days? What if your claims are unclean? The problem is – who determines what is a clean claim? Your payor? Your MAC? If you bill 100 claims and are paid for 50 because 50 claims are denied as not being “clean,” how do you know whether 50 claims were actually unclean? If you disagree with whoever’s determination it is that says your claims aren’t clean, where do you appeal that decision? Can you appeal that determination? The answer is no. In an egregious case, you could litigate and argue that the MAC or whomever is not conducting their job properly.

The Medicare and Medicaid billing, reimbursement, and appeals processes are clear as mud and run contrary to American values and concepts, such as due process and property rights.

CMS codified a rule – “90% of clean claims must be paid to the provider by 30-days,” but never codified an appeal process to dispute decisions. A clean claim is defined as one that can be processed without obtaining additional information from the provider of the service or from a third-party. It includes a claim with errors originating in the State’s claims system. It does not include a claim from the provider who is under investigation for fraud or abuse, or a claim under review for medical necessity.

“Clean” does not mean perfect because the Social Security Act states that claims do not have to be 100% perfect to be “clean.” There is no rule or law that requires claims to be perfect. CMS’ failure to create a definition of clean or an appeal process for the determination of clean, places providers in a very uncomfortable position that their reimbursements are predicated on another entity’s subjective decision as whether the provider billed “clean” claims and no way to refute the allegations or defend themselves from what might be erroneous determinations that the claims were not “clean.”

In CMS Manuel System, Pub. 100-04 Medicare Claims Processing, dated July 20, 2007, CMS uses the phrase “other-than-clean” to describe an unclean claim. CMS also states that “other-than-clean” claims should be notified to the provider within 45 days. As in, you should be told of your uncleanliness within 45-days.

In Southern Rehabilitation Group, PLLC. v. Burwell, 683 Fed. Appx. 354 (6th Cir. 2017), a provider of inpatient rehabilitation health care services brought action against DHHS alleging fraud and other wrongful conduct, such not making timely payments (within 30-days), in processing claims for reimbursement under Medicare. DHHS argued that the unpaid claims were not “clean.” The Court held that the phrase under “clean claims” provision of the Medicare Act referring to treatment that “prevents timely” payment refers to treatment that delays it. The Court allowed DHHS to call claims “not clean,” and the provider had no recourse.

It just seems that so many determinations in Medicare/caid are subjective:

  • “Credible” allegations of fraud. See blog.
  • “Clean” claims
  • Service notes are “compliant.”
  • The patient should not have been designated as “inpatient”
  • 75% “compliant” for three consecutive months. See blog.
  • Managed Care Organizations terminating your contract. See blog.

Many determinations that adversely affect providers have no mechanism to disagree, push back, or appeal.