Health Care Compliance, Fraud and Abuse, & Regulatory Counseling

As many of our readers are likely aware, last week the Supreme Court agreed to hear a second False Claims Act (FCA) issue this term. Having previously accepted and heard argument on a case concerning the government’s authority to dismiss an FCA whistleblower case after declining to intervene, the Court has now granted certiorari to hear two cases addressing what constitutes a “knowing” violation of the FCA. Hanging in the balance is the fate of two lower court decisions that endorsed a powerful defense to FCA liability.

The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims Act (FCA) and the Civil Monetary Penalties Law. Though this proposal purportedly ensures that a lack of “reasonable diligence” cannot create civil liability, it would create significant confusion as to how CMS expects providers and Medicare Advantage organizations (MAOs) to “identify” and quantify potential overpayments before triggering the 60-day period to refund them. The proposed rule, if adopted, would likely become part of the framework for the Department of Justice and Department of Health & Human Services’ Office of Inspector General when evaluating potential liability for the alleged failure to return overpayments.

The Centers for Medicare & Medicaid Services (CMS) recently announced changes to the Medicare Shared Savings Program (MSSP) designed to improve equity within the MSSP and increase the percentage of Medicare beneficiaries in accountable care arrangements.  The changes are included in the Calendar Year 2023 Physician Fee Schedule final rule (Final Rule), which is scheduled for publication on November 18, 2022.

The health omnibus trailer SB-184, which created the Office of Health Care Affordability (OHCA), is set to usher in a significant change in California’s health care regulatory landscape. In this post, we provide a preliminary review of the material changes that are set to begin in 2024.

This blog highlights a recently unsealed qui tam case brought by relator GNGH2, Inc against 15 entities that allegedly operated nursing homes in the Bronx, New York and in Florida and various health care staffing agencies. 

The Supreme Court recently denied petitions for writs of certiorari in three closely watched cases where parties asked the Court to clarify the heightened pleading standard governing fraud allegations under the False Claims Act (FCA). The heightened pleading requirements of Federal Rule of Civil Procedure 9(b) require that, for allegations of fraud (which include FCA claims), “a party must state with particularity the circumstances constituting fraud or mistake.” Among other things, a cause of action for “false claims” must allege the defendants submitted false claims, or caused false claims to be submitted, to the government. The crux of the issue petitioners asked the Court to address is whether, to meet Rule 9(b)’s requirements for FCA causes of action, relators must allege in the complaint specific details of false claims allegedly submitted to the government for payment. This issue typically arises in qui tam cases under the FCA after the government declines to intervene.  

In a significant win for False Claims Act (FCA) defendants, the Eighth Circuit recently reversed a district court decision that defendants violated the FCA premised on violations of the Anti-Kickback Statute (AKS). The Eighth Circuit adopted a stricter but-for causation standard for FCA claims based on AKS violations, holding that, in order to prevail on these claims, the government must prove that FCA defendants would not have submitted claims for particular items or services to Medicare or Medicaid absent the illegal kickbacks. 

Disclosing known or suspected fraud to regulators can have its benefits.  As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation” (the Policy Guidance).  Since then, the industry has been watching to see how  DOJ implements this Policy Guidance. 

Two settlements announced earlier this month seem to demonstrate that DOJ is applying the Policy Guidance in resolving FCA cases.  Although the facts of these two settlements differ significantly, they highlight the benefits of self-disclosure, cooperation with the government in its investigation, and proactive efforts to remediate non-compliance.

On April 27, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services issued Advisory Opinion No. 22-08 (AO 22-08), which addresses an existing arrangement of a federally qualified health center (FQHC) (hereafter, Requestor) that loans limited-use smartphones to enable existing patients’ access to Requestor’s telehealth platform (the Arrangement).  The Arrangement’s purpose is described as increasing access to telehealth services and combating isolation by allowing patients to talk and text with others, including during the COVID-19 public health emergency (PHE).

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a network of laboratories (the Requestor) would compensate hospitals for certain specimen collection services related to testing performed by Requestor (the Proposed Arrangement).  The OIG ultimately concluded that the Proposed Arrangement poses a risk of fraud of abuse under the federal Anti-Kickback Statute (AKS). In this post, we will cover the OIG’s rationale for this decision, as well as some of the history of the OIG’s scrutiny of specimen collection arrangements.

Last week, the Department of Justice (DOJ) announced another significant takedown that it described as “build[ing] on the success of the May 2021 COVID-19 Enforcement Action.”  As part of this enforcement effort, criminal charges were announced against 21 defendants across the country for their alleged involvement in various COVID-19 related fraud schemes that resulted in over $149 million in “COVID-19 related false billings to federal programs and theft from federally-funded pandemic assistance programs.” 

The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a pharmaceutical manufacturer would not result in the imposition of sanctions under the federal Anti-Kickback Statute (AKS) and the beneficiary inducements civil monetary penalty provision (Beneficiary Inducements CMP).  This Advisory Opinion is the first to address this type of arrangement and thus provides useful insight for the health care and life sciences industries.

Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS) is authorized to distribute funds from its Provider Relief Fund (PRF) to certain providers. These providers can then use the funds to support COVID-19 prevention, preparedness, and response, or to alleviate loss of patient care revenue.  However, HRSA requires that providers receiving PRF funds comply with certain requirements, including post-payment reporting requirements.  HRSA is now notifying providers that failed to comply with the reporting requirements that they must return the PRF funds they received. 

During this program, Mintz attorneys Nancy Adams, Lara Compton, Todd Rosenbaum, and Jennifer Rubin provided an overview of key risk factors for telehealth companies and pragmatic takeaways which you can incorporate into your business practices

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued another favorable Advisory Opinion on patient incentives (e.g. gift cards or cash equivalents) given as part of patients’ treatment plans. Though the OIG reiterated its concern that cash and cash equivalents given to patients can present substantial fraud and abuse risks, the OIG concluded that the arrangement presented a minimal level of risk.

Health care providers, health information networks, health information exchanges, and health IT developers of certified health IT will want to take note of the information blocking claim submission trends recently published by the Office of the National Coordinator for Health Information Technology (ONC).

In our annual webinar, Mintz’s Health Care Enforcement Defense team reviewed the key health care fraud enforcement developments and trends from 2021, assessed their likely impact in 2022, and provided recommendations to avoid government scrutiny.

The Department of Justice announced in a February 1, 2022 press release (Press Release) that it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims in the fiscal year ending September 30, 2021 (FY2021) – the second largest annual total recovery in False Claims Act (FCA) history.

On January 19, 2022, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding an online retailer’s proposal to make its discount programs available to Medicaid beneficiaries. Currently, lower-income individuals are eligible for the retailer’s discount programs based on their enrollment in a number of assistance programs (e.g. Supplemental Security Income, Supplemental Nutrition Assistance Program), and the retailer proposes Medicaid enrollment as another category of eligibility.

The next post in our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rule (Proposed Rule), focuses on a regulation impacting Part D sponsors and their reporting of pharmacy price concessions. According to CMS, the proposed change—which would require the “negotiated price” of a covered Plan D drug to be the lowest possible payment made to a pharmacy by a Plan D sponsor—is expected to (i) reduce out-of-pocket costs for plan beneficiaries at the pharmacy counter, (ii) create greater drug price transparency, (iii) stabilize the operating environment for pharmacies and (iv) improve market competition.