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On Friday, August 26, 2022, the Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS), Department of Labor, and Department of Treasury (collectively, the Departments) issued a new Final Rule updating key regulations pertaining to the No Surprises Act. The Final Rule addresses disclosure requirements for group health plans and health insurance issuers related to the Qualified Payment Amount (QPA) for out of network services, as well as establishing the factors and information which certified federal independent dispute resolution (IDR) entities must consider in arbitrating disputes for out of network services or items. The Final Rule takes effect October 25, 2022 and covers services and items rendered during plan years beginning on or after January 1, 2022.

The July 2021 interim final rule initially required group health plans and health issuers to make certain disclosures. When the QPA serves as the recognized amount or the amount that serves as the basis for cost sharing with respect to out of network services, plans and issuers must disclose the QPA and certain related information, as well as certain additional information at the request of the provider or facility. When a plan or issuer down-codes the billed claim, the plan or issuer must automatically provide additional information about the QPA with an initial payment or notice of denial. The additional information must include a statement that the claim was down-coded, an explanation of why the claim was down-coded, and the amount that would have been the QPA had the claim not been down-coded.

In October 2021, the Departments issued their first attempt at establishing the information an IDR entity must consider, however these rules were challenged in court and subsequently vacated. Under the most recent Final Rule, a Federal IDR entity must weigh specific considerations and select the offer that “best represents the value of the qualified IDR service or item” as the out of network rate. Specifically, the IDR entity must consider the QPA for the same or similar qualified IDR service or item for the applicable year, as well as additional information submitted by a party related to:

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued OIG Advisory Opinion No. 22-14 that applied its November 2020 special fraud alert targeting remuneration associated with speaking arrangements funded by pharmaceutical and medical device companies.

The November 2020 special fraud alert addressed potential Anti-Kickback Statute (AKS) risks arising from paying physicians to speak at educational programs and providing benefits to  attendees. OIG outlined several factors that, if present, would increase the risk of an AKS violation.

OIG’s No. 22-14 Advisory Opinion was issued in response to an ophthalmology practice’s proposed continued education program. The practice intended to offer continued education programs to local optometrists, who may be responsible for referring approximately half of the practice’s surgical patients. Although many of the local optometrists refer their patients to the practice, the program would be available to all optometrists in the area, and there would be no obligation to refer patients to the practice after attending the program.

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced several new changes in its Work Plan update in August 2022. The OIG Work Plan forecasts the projects that OIG plans to implement over the foreseeable future. These projects usually include OIG audits and evaluations. Below are the highlights from the Work Plan update of which providers and suppliers should take notice.

First, OIG will perform an audit of selected HHS divisions to evaluate the effectiveness of security controls to determine whether service providers are identifying and reporting cybersecurity events. The audit seeks to ensure HHS’s compliance with the Federal Information Security Management Act and OMB Circular A-130 which requires Federal agencies to ensure that service providers meet the security requirements for transmitting, processing, or storing Federal information.

Second, OIG will perform a nationwide review of skilled nursing facility (SNF) costs for services, facilities, and supplies furnished by entities with common ownership with the SNF. Medicare regulations require that the cost of services, facilities, and supplies furnished to a provider by an organization under common ownership or control be the same or lower than the cost of comparable services and supplies purchased elsewhere. Accordingly, the review will compare these costs to determine whether skilled nursing facilities are reporting these related-party costs in accordance with the Medicare regulations. The review will also consider how a skilled nursing facility’s allocation of Medicare funds can impact beneficiary care.

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More of the long-promised enforcement actions related to COVID-19 pandemic relief and healthcare programs have started to unfold. This time it is demands from the Health Resources and Services Administration (“HRSA”) that providers repay funds they have received for providing COVID-19 testing to the uninsured during the pandemic.

As part of the response to the COVID-19 pandemic, Congress provided funding for testing of patients without health insurance. The funding of testing for the uninsured was overseen by HRSA under the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program. HRSA contracted with Optum to administer the program directly. Generally referred to as “HRSA funding” for testing of the uninsured, this system functioned as a claims reimbursement program wherein eligible healthcare providers submitted claims to HRSA/Optum for reimbursement, made certain attestations, and Optum reimbursed providers’ claims.

Recently, healthcare providers who billed and received reimbursements under this program have begun to receive “assessment” letters from HRSA. HRSA has generally insisted that these are not “audits,” but “assessments.” These letters generally indicate that HRSA made payments to the provider in error and demand that the provider make immediate repayment. The letters generally do not provide denial reasons or explain the nature of the “error,” and do not contain allegations of fraud. They simply demand repayment. The letters also generally do not provide for an appeal process. Where a provider receives a letter, HRSA generally also suspends payment to the provider, pending the completion of an assessment.

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The Departments of Health and Human Services (HHS), Labor, and the Treasury recently issued new guidance for the dispute resolution process under the federal No Surprises Act. The Departments have made several attempts to implement regulations since the No Surprises Act was enacted in late 2020. Some have been interim rules, and some have been struck down by federal courts. This is the first final rule to implement the statute.

Under the No Surprises Act (NSA), if a healthcare provider and insurance company cannot resolve a disagreement over payment for out-of-network services through negotiation, the parties may proceed to a “baseball-style” arbitration. In this process, a third party chooses one appropriate payment from two suggestions offered by the provider and the insurer, taking into account certain considerations. Where the insurer denies or “downcodes” a claim under the No surprises Act, HHS requires the insurer to disclose the Qualified Payment Amount (QPA) for each item or service at issues. The QPA is generally the insurer’s median in-network rate and may be an approximation of what the insurer would have paid for the service if provided by an in-network provider or facility. Under the new rule, HHS has defined “downcode” to mean the alteration by a plan or issuer of the service code to another service code or the alteration, addition, or removal by a plan or issuer of a modifier, if the changed code or modifier is associated with a lower QPA than the service code or modifier billed by the provider, facility, or provider of air ambulance services. Therefore, where this occurs, insurers are required to disclose their QPA.

Further, HHS has been forced to shift course regarding the use of the QPA. Initially, HHS had required that the arbitrators that resolve these disputes defer to the QPA and give it additional weight by selecting the proposed payment amount closest to the QPA. Healthcare providers argued that this over-reliance on the insurer’s QPA was contrary to the No Surprises Act itself and that HHS skipped the notice-and-comment process when implementing it. A federal court agreed and struck down that prior version of the rule. The new rule directs arbitrators to consider the QPA and then consider all additional permissible information submitted by each party to determine which offer best reflects the appropriate out-of-network rate. The arbitrator should then select the offer that best represents the value of the item or service under dispute.

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When a Medicare contractor denies a claim, the provider generally has a right to a lengthy appeal process, which is both complex and contains many strict deadlines. In some circumstances, claims can take years to fully progress through the appeals process. However, some limited cases may be eligible for settlement depending on the circumstances at hand.

The federal agency that oversees Medicare, the Centers for Medicare & Medicaid Services (CMS), performs few audits itself. In most cases, they outsource these audits to a series of independent contractors, such as Medicare Administrative Contractors (MACs), Recovery Audit Contractors (RACs), Unified Program Integrity Contractors (UPICs), and the Supplemental Medical Review Contractor (SRMC). Most audits are performed by these contractors, although they will often use CMS’s name or logo in their correspondence and may answer phone calls by saying that they are “with Medicare.”

A healthcare provider has options when responding to Medicare audits from the very beginning. Sometimes providers receive Additional Document Requests (ADRs) from the contractor demanding information or documentation to support the claims. These requests must be reviewed carefully. However, it is important to note that they often contain generic language that makes it difficult to determine which specific documents the contractor is requesting. Once the contractor reviews the additional documentation supplied, the contractor will issue its audit findings and determine whether to deny certain claims. Other times, the contractor will audit claims data or other information and issue audit findings without requesting additional information from the provider.

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The use of telemedicine has exploded over the last few years. The COVID-19 pandemic spurred a shift from in-person services to services provided by telemedicine. As healthcare providers and patients experience the added convenience of telemedicine in some circumstances, some of the large-scale shifts to telemedicine will likely become permanent. However, with increased use comes increased scrutiny from regulators. The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) and the Department of Justice (DOJ) recently released guidance regarding the provision of telehealth services to individuals with disabilities or with limited English proficiency.

Collectively, several federal laws generally prohibit discrimination on the basis of disability, race, color, and national origin, among other bases. Federal regulations also generally require covered health programs or activities provided by covered entities through electronic or information technology to be accessible to individuals with disabilities unless doing so would result in undue financial and administrative burdens or fundamental alteration of the health program. According to the joint guidance, “A health care provider’s failure to take appropriate action to ensure that care provided through telehealth is accessible can result in unlawful discrimination.”

HHS and DOJ’s guidance generally directs providers to make exceptions to their telemedicine policies or to make special accommodations to individuals with disabilities or limited English proficiency, such as allowing extra time for familiarization with the telemedicine platform or for communication with the provider, allowing caregivers or others to be present during a telemedicine visit, adding additional capabilities or support for functions like real-time captioning or screen reader software, and use of language assistance services. A provider’s obligation to accommodate disabilities over telemedicine is generally the same as when providing in-person services.

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As the COVID-19 pandemic continues to recede, efforts by commercial insurance carriers to claw back millions of dollars paid out for COVID-19 testing services are steadily increasing, creating an ongoing audit risk for healthcare providers, especially clinical labs. In many cases, efforts to get people tested, slow the pandemic, and ask questions later have turned into accusations of over-billing and demands that providers repay the insurance carriers.

Early in the pandemic, Congress required commercial insurers to cover certain claims for COVID-19 testing. However, Congress did not provide the insurers with funds to cover the cost of this mandate and some insurers have pushed back against lab claims for COVID-19 testing. As public opinion and political fervor over the urgency of testing has subsided, commercial insurers are taking advantage of the opportunity to audit COVID-19 testing claims, dispute payments they have made to the labs, and demand that labs make repayment, often for significant portions of the lab’s COVID-19 testing volume. These disputes generally focus on the same issues.

First, insurers may audit labs based on the requirement for an “individualized clinical assessment,” including whether the practitioner was authorized, whether the order for testing was within the scope of state law, whether the assessment was conducted by telemedicine or by a questionnaire, whether the ordering provider used a standing order, and what rules apply where a state does not or did not require an order for COVID-19 testing.

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One of the largest areas of debate in healthcare regulatory compliance is the Eliminating Kickbacks in Recovery Act (EKRA). Despite the many question marks by healthcare providers around how to comply with EKRA, the statute also carries some of the stiffest penalties for failing to do so. Enacted in 2018, EKRA provides criminal penalties for paying, receiving, or soliciting any remuneration in return for referrals to recovery homes, clinical treatment facilities, or laboratories. Although initially intended to apply only to substance abuse and recovery, EKRA was written so broadly that it applies to all clinical laboratory services, not just in connection with substance abuse and recovery. It is unclear if Congress intended this effect, as the expansion to all lab services was included a mere 6 days before the final version of the law passed. Regardless, a violation of EKRA may be punished by fines up to $200,000, imprisonment of up to 10 years, or both, for each occurrence.

EKRA is often compared to other federal regulatory statutes, such as the Physician Self-Referral Law (commonly called the Stark Law) and the Anti-Kickback Statute (AKS). However, EKRA is written incredibly broadly and may prohibit conduct that might otherwise be permissible under the Stark Law and AKS. The Stark Law and AKS also have volumes of regulations and decades of enforcement, such that it is generally well understood how these statutes function, how government agencies view and enforce them, and how to structure arrangements to comply with them. EKRA, on the other hand, has no regulations and few enforcement actions, often leaving healthcare providers with only the bare text of what is potentially a very broad statute.

Recent enforcement actions are beginning to show that EKRA is likely as broad as it appears. Initially, enforcement actions under EKRA were limited to allegations regarding substance abuse and recovery services, as originally intended. But this summer, the Department of Justice (DOJ) charged a clinical lab with an alleged multi-million-dollar healthcare fraud scheme, which included allegations that the lab violated EKRA by paying for referrals for COVID-19 testing, showing a willingness to enforce the full breadth of EKRA on clinical lab services.

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On July 15th, 2022, the U.S. Department of Health and Human Services (HHS) extended the COVID-19 Public Health Emergency by another 90 days. The Public Health Emergency has allowed HHS and various federal agencies to issue waivers of regulatory requirements to ensure that providers have greater flexibility with several issues, including reporting requirements and telehealth reimbursement as the Pandemic grew increasingly dangerous.

The Public Health Emergency has existed since January 27th of 2020. After the last extension of the Public Health Emergency in April of 2022, HHS Secretary Xavier Becerra assured that there will also be a 60-day notice to providers nationwide when HHS decides to terminate the Public Health Emergency.

Although the Public Health Emergency has been extended, it is important to note that the Centers for Medicare and Medicaid Service (CMS) has already started to end some of the regulatory flexibilities implemented during the Public Health Emergency. We discussed the termination of some of these blanket waivers in a previous blog post. Providers who are relying on any of the regulatory waivers should verify whether the waivers remain in effect or have been ended prior to the end of the Public Health Emergency.

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