The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting continued enforcement and recovery actions under the Health Care Fraud and Abuse Control Program (HCFAC). During fiscal year 2022 (FY 2022), over $1.7 billion was returned through HCFAC’s enforcement actions.Continue Reading HHS & DOJ FY 2022 Enforcement Targeted Fraud in COVID-19, Telemedicine, Opioid and Prescription Drugs, and Substance Use Treatment Centers, Among Other Initiatives
Yesterday, the Supreme Court issued a unanimous decision holding that the aggravated identity theft statute –and its mandatory minimum of two years – is not triggered merely because someone else’s identification facilitates or furthers the offense in some way. See Dubin v. United States. We have seen a growing trend of the government adding aggravated identity theft in healthcare fraud cases. As a result of this decision, we may see that statute far less.Continue Reading Is this “Good-Bye” to the Two Year Mandatory Minimum in Healthcare Fraud Cases?
On August 5, President Biden signed two bills into law that extend to ten years the statute of limitations for civil and criminal enforcement actions for fraud on the Paycheck Protection Program (“PPP”) and Economic Injury Disaster Loans (“EIDL”). These two bills—the PPP and Bank Fraud Enforcement Harmonization Act of 2022 and the COVID-19 EIDL Fraud Statute of Limitations Act of 2022—were both passed by Congress with bipartisan support. Continue Reading Statute of Limitations for PPP and EIDL Fraud Extended to Ten Years
The Eighth Circuit Court of Appeals recently tossed a $5.5 million jury verdict finding that a physician violated the False Claims Act (“FCA”) by submitting claims for items and services ordered subsequent to a violation of the Federal health care program anti-kickback statute (“AKS”). According to the appellate court, the trial court’s jury instruction “brushed aside causation” and “misinterpreted” a 2010 amendment to the AKS.Continue Reading Eighth Circuit: In False Claims Act Cases Based On Kickback Violations, the Kickback Violation Must Be the “But For” Cause of the Items and Services Subject to the Claim
The digital health sector has seen tremendous growth and innovation over the past few years. This momentum introduces new complexities within the legal and regulatory landscape that is trying to…
Continue Reading Top 5 Legal Issues in Digital Health to Watch for in 2022
On July 13, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released a Proposed Rule that proposes to amend certain regulations implementing the Physician Self-Referral Law, otherwise known as the “Stark Law”. The Proposed Rule proposes to revise once again the definition of “indirect compensation arrangement” (ICA), effectively to revert the meaning of the definition back – for the vast majority of indirect financial relationships between DHS entities and referring physicians – to the definition of that term as it was in place prior to the latest Stark Law rulemaking, “Modernizing and Clarifying the Physician Self-Referral Regulations” (the “MCR Final Rule”), published on December 2, 2020. The Proposed Rule also proposes to define the term “unit” and the phrase “services that are personally performed”, both for purposes of the ICA definition.
Continue Reading CMS Proposes to Revise, Again, the Stark Law’s Definition of “Indirect Compensation Arrangement”: What Was Old is New Again
As mentioned in our November 25, 2000 Healthcare Law Blog article, “Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays,” the Centers for Medicare & Medicaid Services (CMS) published a final rule (“Final Rule”) on December 2, 2020 making significant changes to the regulatory framework implementing the federal physician self-referral prohibition (the “Stark Law”), 42 C.F.R. 411.351 et seq.
Continue Reading Critical Analysis and Practical Implications of CMS’ Changes to the Stark Law’s Implementing Regulations
On November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) promulgated much-anticipated and significant final rules intended to “modernize” and “clarify” regulations regarding the Physician Self-Referral Law (“Stark Law Final Rule”) and the Anti-Kickback Statute (“AKS Final Rule”). In the immediate future, Sheppard Mullin will post on this Healthcare Law Blog a comprehensive critical analysis of both the Stark Law Final Rule and the AKS Final Rule and their practical impacts.
Continue Reading Big Changes for Health Care Fraud and Abuse: HHS Gifts Providers Updates to the Stark Law and the AKS, Just in Time for the Holidays
In Advisory Opinion No. 18-11, the Department of Health and Human Services Office of the Inspector General (the “OIG”) addressed a Medicaid managed care organization’s (“MCO”) proposal to pay its contracted providers and clinics (“Network Providers”) to increase the amount of Early and Periodic Screening, Diagnostic, and Treatment (“EPSDT”) services they provide to the MCO’s Medicaid members. Under the State’s MCO program, MCOs are required to provide EPSDT services and face liquidated damages for failing to do so. Under the proposed arrangement, the MCO would provide per member incentive payments (“Incentive Payments”) to Network Providers that meet certain benchmarks for increasing the amount of EPSDT services they provide to MCO members. The amount of the Incentive Payments would be determined based on the percentage increase of EPSDT services provided to the MCO’s existing members from one year to the next.
Continue Reading How Broad is the Managed Care Safe Harbor?
 On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum on behalf of the U.S. Department of Justice (DOJ) (the “Brand Memo”) which effectively limits the use and enforcement power of guidance documents for the purposes of affirmative civil enforcement cases, a development that could have a significant impact on how certain healthcare cases are handled at the federal level by federal departments, agencies, and administrations, including those that are fixtures of the healthcare marketplace – the Department of Health and Human Services (HHS) and its constituent agencies, including the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA) and the HHS Office of Inspector General (OIG).
Continue Reading New DOJ Guidance Policy Limits Use of Guidance Documents in Federal Civil Actions
On January 19, 2018, the United States Court of Appeals for the Third Circuit affirmed a district court’s ruling granting summary judgment to a specialty pharmacy that was accused of violating the Anti-Kickback Statute and the federal False Claims Act (United States ex rel. Greenfield v. Medco Health Solutions, Inc. et al., No. 17-1152.). The court held that the relator, a former vice president of the specialty pharmacy, failed to link the pharmacy’s alleged kickback scheme to the actual submission of claims to Medicare. The decision is important because it stands for the proposition that to be liable under the False Claims Act a relator must allege more than the defendant was submitting claims for federal health care program beneficiaries while engaging in kickbacks. Rather, it must allege that at least one claim was submitted for services that were provided in violation of the Anti-Kickback Statute.
Continue Reading Temporal Proximity Is Not Enough: Third Circuit Nixes FCA/Anti-Kickback Suit For Failure To Link Alleged Scheme to Claims