The Well being Assets and Companies Administration (HRSA) Uninsured Program (UIP), which reimbursed suppliers for provision of COVID-19 associated providers to uninsured people, paid out greater than $24.5 billion in claims. Given this quantity, it’s no shock that authorities enforcers have turned their consideration in the direction of scrutinizing the recipients of these funds – the suppliers of testing, remedy, and vaccination providers. Nevertheless, the underlying UIP necessities that the federal government would possibly search to implement are something however clear. We discover on this article the enforcement of 1 explicit program requirement: a supplier’s obligation to confirm a affected person’s uninsured standing.

Specializing in Enforcement Scrutiny of the HRSA UIP. 

That is the second installment in our two-part collection on the mounting scrutiny of recipients of funds underneath the HRSA UIP. In Half One we analyzed the Workplace of Inspector Common’s (OIG) audit of the UIP, launched on July 13, 2023. On this second installment, we give attention to enforcement actions in opposition to suppliers associated to submission of claims to the UIP, and particularly the requirements that suppliers had been anticipated to make use of to find out uninsured standing. 

This spring, the Division of Justice (DOJ) introduced a nationwide motion to fight COVID-19 associated fraud. A number of defendants charged within the motion had been alleged to have participated in fraud schemes aimed on the HRSA UIP. One case particularly supplies particularly helpful perception into how the federal government could plan to prosecute alleged non-compliance with the UIP’s expectation to confirm affected person uninsured standing.

The just lately introduced takedown included a felony criticism in opposition to Dr. Anthony Hao Dinh, a California based mostly doctor and the second highest biller to the UIP, alleging that Dinh executed a scheme to defraud HRSA by submitting false or fraudulent claims together with for providers not rendered, providers that weren’t medically needed, and – as pertinent right here – for sufferers who had been insured on the time the service was rendered (and therefore weren’t eligible for HRSA reimbursement).

What are the Requirements to Decide HRSA UIP Uninsured Standing? 

As alleged within the Grievance, suppliers taking part within the UIP needed to attest – each on the time of enrollment in HRSA and upon submission of affected person rosters – to sure situations, together with that they checked for well being care protection eligibility of sufferers and confirmed that the sufferers had been uninsured and had no protection underneath applications corresponding to Medicare or Medicaid. (No particular supply is cited within the Dinh Grievance for this alleged requirement.) The Grievance additionally references a requirement that suppliers certify through acceptance of the UIP’s Phrases and Circumstances that “to one of the best of [their] information, sufferers recognized on the declare kind had been Uninsured People on the time the providers had been supplied.”

Regardless of these required attestations and certifications concerning the conclusion as to uninsured standing, nowhere in UIP steerage had been suppliers instructed as to how they could verify insurance coverage standing. Nor did the federal government promulgate any regulatory guidelines concerning insurance coverage verification for the UIP, possible due to the pandemic’s chaotic nature and the necessity for a speedy response.

Does the Medicare CWF Present Helpful Data?

Of word, the federal government contends within the Grievance that as a result of Dinh was enrolled in Medicare, he “had the flexibility to make the most of Medicare’s eligibility verification database [also referred to as the Medicare Common Working File (CWF)] to confirm insurance coverage data for sufferers.” In so alleging, the federal government apparently incorporates a requirement, not less than for Medicare enrolled suppliers, to verify the CWF earlier than deciding {that a} affected person is definitely uninsured.

CMS describes the CWF in Chapter 27 of the Medicare Claims Processing Guide as “the Medicare Half A and Half B beneficiary advantages coordination and pre-payment claims validation system”. The CWF itself has many limitations, together with, as maybe most necessary right here, that any checks would solely replicate Medicare sufferers, who would appear to be unlikely to be a major share of these alleging uninsured standing for COVID-19 providers.

In truth, no such requirement to verify the CWF was set forth by HRSA. On the contrary, within the absence of regulation or steerage requiring a particular technique for verifying a affected person’s uninsured standing, any cheap technique of insurance coverage verification would appear acceptable, supplied that it allowed the supplier to satisfy the usual set forth within the UIP’s Phrases and Circumstances that “to one of the best of [their] information” the affected person was uninsured. Numerous strategies utilized by suppliers would seem to fulfill the usual for “cheap” efforts, together with requiring self-reported affected person insurance coverage data or an attestation as to uninsured standing in kinds used to schedule or guide providers. Additionally “cheap” could be using third-party instruments to confirm insurance coverage standing via looking exterior databases. 

Do the Medicare Secondary Payer Guidelines Apply by Analogy? 

Whereas the Medicare guidelines don’t expressly apply to the UIP, the UIP’s necessities to confirm insurance coverage standing discover an analogy within the Medicare Secondary Payer (MSP) guidelines and explanatory steerage. These provisions equally require that the supplier affirm there isn’t a different insurance coverage that ought to pay earlier than Medicare pays. With respect to MSP, the statutory language of Social Safety Act § 1862(b)(6) underscores the reliance put “on data obtained from the person”; and a associated regulation at 42 C.F.R. § 411.24(l)(2)(ii) permits for no restoration in opposition to the supplier if the explanation for the supplier’s failure to file a correct declare looking for fee from different well being protection was as a result of the beneficiary, or somebody performing on his or her behalf, failed to offer, or gave faulty, data concerning protection that’s main to Medicare. It seems cheap that these ideas might (and will) be equally utilized within the context of the UIP, particularly given the UIP’s lack of the subtle extra processes utilized within the MSP context to verify that there isn’t a different well being protection. Accordingly, UIP-enrolled suppliers ought to be capable to argue that they met the UIP’s requirement of verification of uninsured standing “to one of the best of their information” in the event that they solicited and relied upon sufferers’ self-reported insurance coverage standing.

Suppliers who did not request affected person insurance coverage data or in any other case confirm affected person insurance coverage standing is probably not saved by this argument, nevertheless. For example, in a single case filed in U.S. District Court docket for the District of Minnesota, a supplier allegedly instructed staff to pick “uninsured” if a affected person’s insurance coverage was not included in a pre-populated record of payors that the federal government claims didn’t embody “most, if not all, Minnesota insurance coverage corporations.” However, there could have been different means employed by that supplier and lots of others that might additionally fulfill the UIP’s “better of their information” normal; we might be watching this case (amongst others) to see if such defenses are raised there. 

What Comes Subsequent? 

We anticipate to see extra enforcement alleging fraud in opposition to HRSA within the coming years. The Dinh case mentioned above arose from a referral from the third-party entity contracted to manage the UIP, however it’s clear from the criticism that the federal government additionally utilized information analytics to strengthen their case in opposition to Dinh. This serves as simply one other instance of the federal government’s utilization of knowledge analytics in enforcement actions, which we anticipate to accentuate.

The OIG’s audit of the UIP (which we mentioned in Half One of this collection) describes HRSA’s ongoing course of for assessing suppliers’ compliance with program necessities for reimbursement. Suppliers who participated within the UIP ought to put together to bear audits of their involvement in this system. Suppliers also needs to keep data associated to their involvement within the UIP, together with data associated to their efforts to confirm insurance coverage standing.

Foley is right here that can assist you handle the short- and long-term impacts within the wake of regulatory modifications. We’ve the assets that can assist you navigate these and different necessary authorized concerns associated to enterprise operations and industry-specific points. Please attain out to the authors, your Foley relationship accomplice, or to our Well being Care Observe Group with any questions.