Category Archives: Knicole Emanuel
The American Hospital Association (“AHA”) is asking the Department of Justice (DOJ) to look into health insurance companies that routinely deny patients access to care and payments to providers. I’d like a task force as well. This is exactly the problem I have witnessed with managed care organizations or MCOs. In traditional Medicare and Medicaid, MCOs are prepaid and make profit by denying consumers medical care, terminating provider contracts, and not paying providers for care rendered. Congress created the same scenario with Medicare Advantage. Individuals can elect coverage through private insurance plans. While MA has been wildly successful and popular, the AHA is complaining that too many people are getting denied services.
An OIG report that was published in April cites MAOs as denying services for beneficiaries. We are always talking about providers getting audited, it is about time that the companies that are gateways for providers getting reimbursed and beneficiaries getting medically necessary services are likewise audited for denying services. It seems ironic that providers are audited for potentially billing for too many services and these gateway, third party reimbursement companies are audited for providing too few services – or denying too many prior authorizations. But if the MCO or MAO deny medical services, then the money that would have been paid to the provider stays in their pocket.
The OIG report found that many MAOs delay or deny services despite those services meeting Medicare prior authorization criteria, approximately 13-18%. Almost a 20% wrongful denial rate. When these MAOs get tax payer money for a Medicare beneficiary and deny services those tax dollars stay in the MAO’s pockets.
Supposedly MAOs approve the vast majority of requests for services and payment, they issue millions of denials each year, and OIG’s audit of MAOs has highlighted widespread and persistent problems related to inappropriate denials of services and payment. As enrollment in Medicare Advantage continues to grow, MAOs play an increasingly critical role in ensuring that Medicare beneficiaries have access to medically necessary covered services and that providers are reimbursed appropriately.
According to the OIG report, MAOs denied prior authorization and payment requests that met Medicare coverage rules by: (1) using MAO clinical criteria that are not contained in Medicare coverage rules; (2) requesting unnecessary documentation; and (3) making manual review errors and system errors.
Personally, I am fed up with these private, insurance companies denying services and keeping our tax dollars. It is about time the insurance companies are audited.
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:
- The Supreme Court
- Appellate Courts
- The real world outside of CMS
- District Courts
- The Department of Transportation
- Civil Jurisprudence
- The Department of Education
- 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:
- 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.
- 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.
- When sampling is used, providers are not able to bill individual beneficiaries not in the sample group for the services determined to be noncovered.
- Use of a sampling procedure violates the rights of providers to appeal adverse determinations.
- 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?
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.
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.
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.
- 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.
(On a personal note, I apologize for how long since it has been my last blog. I was in an accident and spent 3 days in the ICU.)
I’d like to write today about the sheer absurdity about how these RAC, ZPIC, MAC, and other types of audits are being held against health care providers. When an auditor requests documents from a provider and opines that the provider owes a million dollars in alleged overpayments, I would expect that the auditor will show up before an independent tribunal to defend its findings. However, for so many of these Medicare provider appeals, the auditor doesn’t appear to defend its findings.
In my opinion, if the entity claiming that you owe money back to the government does not appear at the hearing, the provider should automatically prevail. A basic legal concept is that the accused should be able to confront its accuser.
I had depositions the last two weeks for a case that involved an opiate treatment program. The two main accusers were Optum and ID Medicaid. When Optum was deposed, they testified that Optum did not conduct the audit of the facility. When ID Medicaid was deposed, it contended that Optum did conduct the audit at issue.
When not one person can vouch for the veracity of an audit, it is ludicrous to force the provider to pay back anything. Auditors cannot hide behind smoke and mirrors. Auditors need to testify to the veracity of their audits.
To poke holes in Medicare audits, you need to know the rules. You wouldn’t play chess without knowing the rules. Various auditor have disparate look-back period, which is the time frame the auditor is allowed to look back and review a claim. For example, RACs may only look back 3 years. Whereas ZPICs have no specific look back period, although I would argue that the older the claim, the less likely it is to be recouped. There is also the federal 48-month limit to look backs absent accusations of fraud.
When appealing the outcome of a MAC or RAC audit, it is necessary for providers to have a specific reason for challenging the auditors’ determinations. Simply being dissatisfied or having generalized complaints about the process is not enough. Some examples of potential grounds for challenging a MAC or RAC determination on appeal include:
- Application if inapplicable Medicare billing rules
- Misinterpretation of applicable Medicare billing rules
- Reliance on unsound auditing methodologies
- Failure to seek an expert opinion
- Ignoring relevant information disclosed by the provider
- Exceeding the MAC’s or RAC’s scope of authority
It is imperative that you arm yourself in defending a Medicare audit, but if the auditor fails to appear at any stage in litigation, then you should call foul and win on a “absent” technicality.
It’s hard enough to be one of the providers to accept Medicare and Medicaid. The regulatory oversight is burdensome. You are always getting metaphorically yelled at for upcoding or bundling. See blog, thanking providers.
One of the absolute, most-Draconian penalty against a Medicare or Medicaid provider is prepayment review.
Prepayment review is exactly as it sounds. Before you receive payment – for services rendered – an auditor reviews your claims to determine whether you should be reimbursed. Prepayment review is the epitome of being guilty until proven innocent. It flies in the face of American due process. However, no one has legally fought its Constitutionality. Yet many provider-companies have been put out of business by it.
Generally, to get off prepayment review, you have to achieve a 75% or 80% success rate for three consecutive months. It doesn’t sound hard until your auditors – or graders – fail to do their job correctly and fail you erroneously.
Usually, when a provider is placed on prepayment review, I say, “Well, you cannot appeal being placed on prepayment review, but we can get a preliminary injunction to Stay the withhold of reimbursements during the process.” It tends to work.
Most State statutes have language like this:
“(f) The decision to place or maintain a provider on prepayment claims review does not constitute a contested case under Chapter 150B of the General Statutes. A provider may not appeal or otherwise contest a decision of the Department to place a provider on prepayment review.”
However, in a recent case, Halikierra Community Services, LLC v. NCDHHS, the provider disputed being placed on prepayment review and accused NCDHHS of a malicious campaign against it.
Halikierra was the largest, in-home, Medicaid health care provider and it alleged that 2 specific, individuals at DHHS “personally detested” Halikierra because of its size. As an aside, I hear this all the time. I hear that the auditors or government have personal vendettas against certain providers. Good for Halikierra for calling them out!
According to the opinion, these 2 DHHS employees schemed to get Halikierra on prepayment review by accusing it of employing felons, which is not illegal. (Just ask Dave’s Killer Bread). Halikierra sued based on substantive due process and equal protection rights, but not before being forced to terminate its 600 employees and closing its doors because of being placed on prepayment review. It also asserted a claim of conspiracy in restraint of trade under NCG.S. §75-1 against the individual DHHS employees.
The Court held that “[t]he mere fact that an agency action is nonreviewable under the Administrative Procedure Act does not shield it from judicial review.” The upshot? Even if a statute states that you cannot appeal being placed on prepayment review, you can sue for that very determination.
FYI – This case was filed in the Industrial Commission, which has jurisdiction for negligence conducted by the state agencies. Exhaustion of administrative remedies was not necessary because, per the state statute, being placed on prepayment review does not constitute a contested case in administrative court.
On January 25, 2022, the U.S. Court of Appeals for the Second Circuit issued an important opinion in Barrows v. Becerra that will have a significant impact on hospitals, skilled nursing facilities and, potentially, other Medicare providers. The Second Circuit affirmed a ruling from the United States District Court for the District of Connecticut that the U.S. Secretary of Health and Human Services (HHS) violated the due process rights of a certified nationwide class of Medicare patients that were reclassified from “inpatient” to “observation” by a hospital’s utilization review committee (URC) without being provided an administrative review process to challenge that determination.
Although hospitals (and other Medicare providers and suppliers) are not typically considered to be governmental actors, the Second Circuit affirmed the district court’s conclusion that the Centers for Medicare and Medicaid Services (CMS) requirements surrounding hospital URCs made those determinations “state action” and thus subject to due process requirements under the Fifth Amendment of the U.S. Constitution.
The classification from “inpatient” to “observation” can have significant financial repercussions to the Medicare beneficiary. Hospital inpatient services are generally covered under Medicare Part A. Outpatient or observation services are generally covered under Medicare Part B. Medicare beneficiaries pay monthly premiums for Part B coverage and also are subject to copayment obligations under Part B that may be higher than the inpatient deductible under Part A.
The Second Circuit’s opinion has huge ramifications on providers, especially hospitals. This opinion says a hospital stands in the shoes of the government when deciding to charge this person’s hospital stay under Part B. But what if the hospital itself argues that Part A should pay and it disagrees with the patient being deemed outpatient? Well, this ruling gives hospitals a lot more leeway in its finances. A hospital can sue on behalf of its consumer or itself in getting higher or any reimbursements.
The threshold question presented in Barrows was whether CMS’s oversight and control over hospital URC’s reclassification determinations transform those URCs into state action and thus subject to constitutional due process. The Second Circuit affirmed the district court’s decision, which also included a permanent injunction, requiring the HHS Secretary to create some sort of due process if a Medicare beneficiary disagrees with a hospital URC’s reclassification determination.
This decision may also favorably impact skilled nursing facilities. Generally, a Medicare beneficiary must have a three-day inpatient stay at a hospital in order for Medicare to pay for a subsequent stay in a skilled nursing facility. This three-day requirement is currently waived during the COVID-19 public health emergency. Once the three-day-stay requirement returns, this decision may positively impact skilled nursing facilities by discouraging hospitals from reclassifying patients from inpatient to observation.
Although the district court decision was issued in 2020, the Second Circuit had granted a temporary stay to allow the HHS Secretary to appeal. In the Second Circuit’s opinion, the Court affirmed the district court and denied the HHS Secretary’s motion for stay as moot.
At this stage, HHS has not signaled what due process hospital URCs will have to provide a Medicare beneficiary who disagrees with a reclassification determination. There are also open questions about how to handle potential claims for various members of the class. The class includes Medicare beneficiaries who have been hospitalized since January 1, 2009, had their status changed from inpatient to hospital, received a notice from the hospital or Medicare, and either have Part A-coverage only or had Part A and B and were (or still could be) admitted to a skilled nursing facility within 30 days of hospital discharge.
The HHS Secretary has until late April 2022 to file a petition for writ of certiorari in the U.S. Supreme Court. At the time of this publication, HHS has not indicated whether it intends to appeal.
It’s a miracle! HHS has reduced the Medicare appeals backlog at the Administrative Law Judge (“ALJ”) level by 75 %, which puts the department on track to clear the backlog by the end of the 2022 fiscal year. The department had 426,594 appeals bottlenecked on backlog. An audit from 2016 could get heard by an ALJ in 2021. However, movement has occurred.
According to the latest status report, HHS has 86,063 pending appeals remaining at the Office of Medicare Hearing and Appeals (“OMHA”).
In 2018, a federal Judge ruled in favor of the American Hospital Association (“AHA”) and its hospital Plaintiffs and Ordered HHS to eliminate the backlog of appeals by the end of FY 2022 and provided the department with a number of goals. According to the ruling, HHS had to reduce the backlog by 19 percent by the end of FY 2019, 49 percent by the end of FY 2020, and 75 percent by the end of FY 2021. Originally, the Order scheduled the timeframe for disseminating the backlog much shorter, but CMS claimed impossibility.
On another note, lately, I’ve seen a lot of supposed audit results based on local coverage determinations (“LCDs”) or policy manuals. This is unacceptable. In a January 4, 2022, decision from the NC Court of Appeals, the Court held that when a State agency implements an unpromulgated rule, the rule may not be enforced. Hendrixson v. Div. of Soc. Servs., 2022-NCCOA-10, ¶ 9. The Hendrixson case piggybacks the Supreme Court, which held that LCDs are unenforceable against providers. Azar v. Allina Health Services, 139 S. Ct. 1804, 204 L. Ed. 2d 139 (2019).
In Hendrixson v. Division of Social Services, the Court held that people eligible for Medicare Part B must apply and enroll and that if the applicant fails to enroll, Medicaid pays no portion of the costs for medical services that would have been covered by Medicare Part B, as you know Medicare Part B provides coverage for certain hospital outpatient services, physician services, and services not covered by Part A. See Bruton, 134 N.C. App. at 42, 516 S.E.2d at 635; 42 U.S.C. § 1395k (2019); 42 C.F.R. § 407.2 (2020). Enrollment in Medicare Part B is generally not automatic, see 42 C.F.R. §§ 407.4-407.40 (2020), and requires the patient to pay insurance premiums to enroll, after which the federal government pays most of the reasonable costs, with patients paying the remaining cost and an annual deductible. See Bruton, 134 N.C. App. at 42, 516 S.E.2d at 635; 42 U.S.C. §§ 1395l, 1395r-1395s (2019); 42 C.F.R. § 407.2 (2020). “Together, the part B premiums, deductibles and coinsurance are generally referred to as ‘Part B cost-sharing.’” Bruton, 134 N.C. App. at 42, 516 S.E.2d at 635. At your hospital or health care entity, do you have someone dedicated to properly enrolling consumers into Medicare Part B? If not, you may want to consider as a financial investment. Additionally, while you do not want to ignore the LCDs, the LCDs or Manuals cannot be a basis for any alleged recoupment or other sanction. As a general canon, any unpromulgated rule cannot be the basis of any penalty.
 The ALJ level is the third level in Medicare provider audits, but the first time that providers are allowed to present evidence to an independent tribunal.
Auditors are overzealous. I am not telling you anything you don’t know. Auditors cast wide nets to catch a few minnows. Occasionally, they catch a bass. But, for the most part, innocent, health care providers get caught in the overzealous, metaphoric net. What auditors and judges and basically the human population doesn’t understand is that accusing providers of “credible allegations of fraud” and alleged overpayments, when unfounded, has a profound and negative impact. First, the providers are forced to hire legal counsel at an extremely high cost. Their reputations and names get dragged through the mud because providers are guilty until they are proved innocent. Then, once they prove that there is no fraud or noncompliant documents, the wrongly accused providers are left with no recourse.
The audits generally result in similar reasoning for denials. For instance,
- Lacks medical necessity. Defense: The treating physician rule. Deference must be given to the treating physician, not the desk reviewer who has never seen the patient.
- Canned notes: Defense: While canned notes are not desirable, it is not against the law. There is no statute, regulation, or rule against canned notes. Canned notes are just not best practices. But, in reality, when you serve a certain population, the notes are going to be similar.
- X-rays tend to be denied for the sole reason that there are no identifying notes on the X-ray. Or the printed copy of the X-ray you submit to the auditors is unreadable. Defense/Proactive measure: When you submit an X-ray, include a brief note as to the DOS and consumer.
- Signature illegible; therefore, no proof of provider being properly trained and qualified. Defense: This one is easy; you just show proof of trainings, but to head off the issue, print your name under your signature or have it embedded into your EHR.
- Documentation nitpicking. The time, date, or other small omissions result in many a denial. Defense: There is no requirement for documents to be perfect. The SSA provides defenses for providers, such as “waiver of liability” and “providers without fault.” The “waiver of liability” defense provides that even if payment for claims is deemed not reasonable and necessary, payment may be rendered if the provider did not know and could not have been reasonably expected to know that payment would not be made.
Whenever a client tells me – let’s concede these claims because he/she believes the auditors to be right, I say, let me review it. With so many defenses, I rarely concede any claims. See blog for more details.