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EnforceMintz — 2022 Teed Up Two False Claims Act Issues That the Supreme Court Is Poised to Answer in 2023
February 9, 2023 | Blog | By Samantha Kingsbury, Kevin McGinty
Mintz Member and Chair of the firm’s Health Law and Health Care Enforcement Defense Practices Karen Lovitch was interviewed for an article included in the January 2023 issue of Laboratory Economics covering the top compliance challenges faced by clinical laboratories, Covid-19 testing fraud, and more.
Supreme Court Justices Agree to Hear Second FCA Issue This Term
January 19, 2023 | Blog | By Samantha Kingsbury, Kevin McGinty
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.
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OCR Warns Providers Against Disclosing PHI on Social Media Platforms in Response to Negative Reviews in Settlement with Dental Practice
December 22, 2022 | Blog | By Lara Compton, Kathryn Edgerton, Pat Ouellette
As illustrated by a recent Office for Civil Rights (OCR) settlement with a dental practice, health care entities continue to struggle with how to respond to negative online reviews while maintaining compliance with the HIPAA Privacy Rule. Given the significant reputational harm that negative reviews on Yelp and other social media and public platforms (Platforms) can create, providers may be tempted to respond to such negative comments with patient specifics in an attempt to mitigate harm to their businesses.
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Supreme Court Declines to Weigh in on False Claims Act Pleading Requirements
October 25, 2022 | Blog | By Brian Dunphy, Laurence Freedman, Ashley Markson
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.
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Pharmaceutical Manufacturer Pays $7.9 Million to Resolve Allegations that it Caused the Submission of Over-the-Counter Drugs to Medicare Part D
September 20, 2022 | Blog | By Joanne Hawana, Rachel Yount
On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of over-the-counter (OTC) drugs to Medicare Part D in violation of the False Claims Act (FCA). Because Medicare Part D only covers prescription drugs, the pertinent drugs were not eligible for Medicare reimbursement. The conduct at issue under this settlement is a relatively novel basis for FCA liability, but we may see similar government enforcement actions in the future as the federal government actively encourages drug manufacturers to “switch” prescription drugs to OTC status in order to enhance their accessibility and reduce costs. This blog post provides an overview and analysis of the settlement.
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Eighth Circuit Adopts Stricter But-For Causation Standard for False Claims Act Claims based on Anti-Kickback Violations
August 18, 2022 | Blog | By Kevin McGinty, Rachel Yount
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.
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Two Recent False Claims Act Settlements Highlight the Benefits of Self-Disclosure, Remediation, and Cooperation
July 19, 2022 | Blog | By Karen Lovitch, Lauren Moldawer, Jane Haviland
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.
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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.
DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action
April 28, 2022 | Blog | By Samantha Kingsbury
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.”
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OIG Issues Another Favorable Advisory Opinion on Treatment-Based Patient Incentives
March 15, 2022 | Blog | By Rachel Yount
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.
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ONC Publishes Report, Commentary on Information Blocking Rule Claims Trends
March 7, 2022 | | By Pat Ouellette
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).
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Webinar Recording: Health Care Enforcement Year in Review & 2022 Outlook
February 16, 2022 | Webinar | By Grady Campion, Randy Jones, Samantha Kingsbury, Karen Lovitch, Kevin McGinty
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.
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Health Care Enforcement Year in Review & 2022 Outlook
February 11, 2022 |
In our annual Health Care Enforcement Year in Review & Outlook report, we examine the data and explore health care enforcement trends and likely targets of government scrutiny for 2022 and beyond.
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False Claims Act Settlements and Judgments Exceed $5.6 Billion in Fiscal Year 2021
February 2, 2022 | Blog | By Laurence Freedman, Jane Haviland
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.
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First Circuit Adopts Deferential Standard for Review of Government Decisions to Dismiss FCA Whistleblower Cases
January 27, 2022 | Blog | By Kevin McGinty, Samantha Kingsbury
In a decision issued late last week, the First Circuit has adopted a deferential standard for review of government decisions to seek dismissal of whistleblower lawsuits brought under the False Claims Act (FCA). The court held that so long as the government explains its decision and provides the whistleblower with an opportunity to respond, the government’s motion must be granted absent evidence of collusion or unconstitutionality. This decision deepens a circuit split on the applicable standard under the FCA when the whistleblower objects to a government motion for dismissal.
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OIG Approves Online Retailer’s Discount Program
January 25, 2022 | Blog | By Rachel Yount
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.
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Information Blocking Rule: Key Considerations for 2022
December 29, 2021 | Blog | By Pat Ouellette
While the Office of the National Coordinator for Health Information Technology (ONC) issued the 21st Century Cures Act; Interoperability, Information Blocking, and the ONC Health IT Certification Program (Information Blocking Final Rule) back in May 2020, many entities are still parsing out compliance strategies and seeking additional regulatory guidance to understand how the rule will be enforced. Broadly-speaking, information blocking is a practice that is likely to interfere with, prevent, or discourage access, exchange, or use of electronic health information (EHI). For example, a health system might require patient written consent before sharing the patient’s EHI with unaffiliated providers. Another example of information blocking is that a health IT developer might charge a fee to a health care provider to perform an export of EHI so that the provider can switch to a different health IT platform.
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Webinar Recording: Telehealth Regulation & Enforcement: 2021 Year in Review & 2022 Outlook
December 7, 2021 | Webinar | By Alexander Hecht, Ellen Janos, Karen Lovitch, Kate Stewart
Over the past year, the demand for health care via telehealth has continued to skyrocket as a result of the COVID-19 pandemic and the public’s increased comfort with obtaining health care goods and services virtually. Join Ellen Janos, Karen Lovitch, Kate Stewart and Alex Hecht as they demystify the current status of laws and regulations, untangle the web of legislation before Congress related to the expansion of telehealth services, discuss recent enforcement activity, and look ahead to trends we see on the horizon.
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OIG Reiterates its Longstanding Concern about Joint Ventures between Health Care Providers/Suppliers and Referral Sources
December 1, 2021 | Blog | By Rachel Yount
On November 22, 2021, the Office of Inspector General for the Department of Health and Human Services (OIG) posted a negative Advisory Opinion regarding a proposed joint venture (JV) for the provision of therapy services (Proposed Arrangement) between an existing therapy services provider (Therapy Services Provider) and the owner of long-term care facilities (LTC Owner). This Advisory Opinion is yet another example of OIG guidance reiterating its view that joint ventures formed between entities in the position to provide health care items or services and entities in the position to refer business can present risk under the federal Anti-Kickback Statute (AKS).
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OIG Revises and Renames the Provider Self-Disclosure Protocol
November 10, 2021 | Blog | By Karen Lovitch, Rachel Yount
For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other entities to voluntarily disclose and resolve instances of potential fraud involving federal health care programs, including potential overpayments and Anti-Kickback Statute (AKS) violations. The OIG originally published the SDP in 1998, and has since modified the SDP several times generally to make the SDP a more appealing option for providers and other health care entities.
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