Archives: False Claims Act

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HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

By Robinson+Cole's Health Law Group on Posted in Academic Medical Centers, Accountable Care Organizations, Ambulatory Surgical Centers (ASC), False Claims Act, Fraud and Abuse, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Home Health Agencies, Hospice, Hospitals and Health Systems, Medicare and Medicaid, Office of Inspector General, Pharmaceuticals and Biologics, Pharmacy Law, Physicians and Allied Health Professionals, Telemedicine

On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector General (OIG) published two final rules (available here: November 30 Final Rule and December 2 Final Rule) which modify the safe harbor regulations to the federal Anti-Kickback Statute (AKS) and codify a new exception to the Civil Monetary Penalty (CMP) Rules related to beneficiary inducements. Most of the changes are effective January 19, 2021.

Together with the new physician self-referral law (also known as Stark) regulations published by the Centers for Medicare …

Massachusetts Federal Court Declines to Apply State Medical Peer Review Privilege in Federal Whistleblower Case

By Conor Duffy and Peter Struzzi on Posted in Academic Medical Centers, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medical Staff and Peer Review, Physicians and Allied Health Professionals

On November 3, 2020, a Massachusetts Federal District Court issued a notable decision on the applicability of the state’s medical peer review privilege in a federal proceeding, determining that the privilege does not apply to documents requested in discovery as part of a qui tam False Claims Act (FCA) case. In United States ex rel. Wollman v. Massachusetts General Hospital, Inc. et al., Case Number 1:15-cv-11890-ADB, the court reviewed the purpose of the peer review privilege and precedent addressing the applicability of state privileges under the Federal Rules of …

CMS Extends Timeline for Finalizing Changes to Physician Self-Referral (Stark) Law Regulations to August 2021

By Conor Duffy on Posted in Academic Medical Centers, COVID-19, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Legislation, Medicare and Medicaid, Physicians and Allied Health Professionals, Privacy and Security, Reimbursement, Stark Law

On August 24, 2020, the Centers for Medicare & Medicaid Services (CMS) announced an “extension of the timeline” for publication of a final rule addressing changes to the Physician Self-Referral Law (or Stark Law) regulations.  In its announcement, CMS set a new deadline of August 31, 2021 for publication of a final rule.…

HHS Extends Compliance Deadline for Providers Receiving CARES Act Provider Relief Funds and Reminds Providers of June 3 Deadline Related to Additional Relief Fund Payments

By Conor Duffy on Posted in Academic Medical Centers, Ambulatory Surgical Centers (ASC), COVID-19, Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Home Health Agencies, Hospitals and Health Systems, Legislation, Long Term Care and Nursing Homes, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals, Reimbursement

On May 22, 2020 the U.S. Department of Health and Human Services (HHS) issued a 45-day extension of the deadline for providers who receive payments from the CARES Act Provider Relief Fund to accept the Terms and Conditions attached to such payments. Providers now have up to 90 days from the date a payment is received to accept the Terms and Conditions or return the funds to HHS.  In its announcement, HHS reiterated its prior position that “Providers that do not accept the Terms and Conditions after 90 days of …

CMS Issues Explanatory Guidance of Blanket Physician Self-Referral (Stark) Law Waivers for COVID-19 in Response to Industry Feedback

By Conor Duffy on Posted in Academic Medical Centers, COVID-19, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement, Stark Law

Amidst the cavalcade of regulatory and policy changes from federal and state governments intended to help health care providers confront the COVID-19 pandemic, on April 21, 2020 the Centers for Medicare & Medicaid Services (CMS) published “Explanatory Guidance” (Guidance) of the applicability of the blanket waivers of the federal Physician Self-Referral Law (PSR Law) CMS previously issued on March 30, 2020. See our analysis of the PSR Law blanket waivers here.…

OIG Will Not Impose Administrative Sanctions for AKS Violations for Conduct Covered by Certain Blanket Waivers of the Stark Law

By Conor Duffy on Posted in Academic Medical Centers, COVID-19, Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals, Reimbursement, Stark Law

On April 3, 2020 the Office of Inspector General (OIG) issued a Policy Statement to notify health care providers and other parties subject to the Anti-Kickback Statute (AKS) that the OIG will not impose administrative sanctions for potential AKS violations for COVID-19-related arrangements that are covered by some – but not all – of the Blanket Waivers of the Physician Self-Referral (Stark) Law issued on March 30 (see here for our analysis of the Blanket Waivers).…

DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

By Conor Duffy on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Healthcare Technology, Office of Inspector General, Pharmaceuticals and Biologics, Reimbursement

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company that resolves parallel criminal and civil investigations involving allegations of kickbacks, false claims, and non-compliance with federal EHR program requirements. We previously discussed a preliminary settlement in this case here, and in announcing the finalizing of that settlement the DOJ has shed more light on the allegedly improper conduct at issue. According to the DOJ, this is the first criminal action ever brought against …

DOJ Reaches Settlement with Patient Assistance Foundation Resolving Allegations of FCA Violations

By Nathaniel Arden on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Medicare and Medicaid, Office of Inspector General, Pharmaceuticals and Biologics

On January 21, 2020, the Department of Justice (DOJ) announced a $3 million settlement with Patient Services, Inc. (PSI) to resolve allegations of False Claims Act (FCA) violations. The DOJ alleged that PSI enabled three pharmaceutical companies to pay kickbacks to patients by funneling money to patients taking drugs manufactured by those same pharmaceutical companies. In addition to the $3 million, PSI has entered into a three-year integrity agreement with Health and Human Services’s Office of the Inspector General. The settlement involved no determination of liability.…

DOJ Announces $26.67 Million Settlement with Laboratory to Resolve FCA Allegations

By Melissa (Lisa) Thompson on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medicare and Medicaid, Office of Inspector General, Stark Law

On November 26, 2019, the Department of Justice (DOJ) announced a $26.67 million settlement with a laboratory testing corporation, Boston Heart Diagnostics Corporation (Boston Heart). The settlement resolves allegations of False Claims Act (FCA) violations related to alleged payments for patient referrals in violation of the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (PSR Law) – commonly known as the Stark Law – and other improper billing.…

DOJ Announces Physician Self-Referral (Stark) Law Settlement in Excess of $46 Million with California Health System and Surgical Group

By Robinson+Cole's Health Law Group on Posted in Ambulatory Surgical Centers (ASC), Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement, Stark Law

On November 15, 2019, the Department of Justice (DOJ) announced it had reached a settlement with Sutter Health (Sutter) and Sacramento Cardiovascular Surgeons Medical Group Inc. (Sac Cardio) to resolve alleged violations of the Physician Self-Referral Law (PSR Law), commonly known as the Stark Law. Sutter is a California-based health services provider; Sac Cardio is a Sacramento-based practice group of three cardiovascular surgeons. The total settlement in excess of $46 million includes $30.5 million from Sutter to resolve allegations of an improper financial relationship specific to compensation arrangements with Sac …

Government Releases Proposed Rules on Physician Self-Referral Law (Stark Law), Anti-Kickback Statute and CMP Law; Significant Regulatory Changes Intended to Encourage Care Coordination and Value-Based Care

By Conor Duffy and Melissa (Lisa) Thompson on Posted in Academic Medical Centers, Accountable Care Organizations, Commercial Health Insurance, False Claims Act, Fraud and Abuse, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Hospitals and Health Systems, Legislation, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals, Reimbursement, Stark Law

On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions and safe harbors, for the federal Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS), and the beneficiary inducement Civil Monetary Penalties Law (CMP). The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update exceptions to the Physician Self-Referral Law (the PSR Rule), and the HHS Office of Inspector General (OIG) issued a proposed rule to update the …

DOJ Reaches $21.36 Million Agreement with Compounding Pharmacy, Two of its Executives, and Managing Private Equity Firm to Resolve FCA Allegations

By Leslie Levinson and Conor Duffy on Posted in False Claims Act, Fraud and Abuse, Government Enforcement, Pharmaceuticals and Biologics, Physicians and Allied Health Professionals, Private Equity, Reimbursement, Telemedicine

On September 18, 2019, the Department of Justice (DOJ) announced a $21.36 million settlement with compounding pharmacy Patient Care America (PCA), as well as PCA’s Chief Executive, PCA’s former Vice President of Operations, and a private equity firm (PE Firm) that managed PCA on behalf of investors. The settlement resolves a False Claims Act (FCA) lawsuit alleging involvement in a kickback scheme designed to generate unnecessary referrals for prescription pain creams, scar creams, and vitamins reimbursed by TRICARE, the federal health care program for military members and their families. No …

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

By Conor Duffy on Posted in False Claims Act, Fraud and Abuse, Government Enforcement, Life Sciences, Medicare and Medicaid, Pharmaceuticals and Biologics, Pharmacy Law, Reimbursement

On September 4, 2019, the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two whistleblower suits filed under the False Claims Act (FCA). The settlement addresses allegations of AKS violations between 2009-2013 by sales representatives of a company later acquired by Mallinckrodt via the “wining and dining” of physicians to induce Medicare prescriptions of that company’s drug. Interestingly, the settlements do not cover related allegations within those FCA suits that Mallinckrodt improperly …

Eleventh Circuit Endorses Objective Falsehood Standard for False Claims Cases Concerning Physician Judgment of Hospice Eligibility

By Leslie Levinson and Conor Duffy on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospice, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement

“A mere difference of opinion between physicians, without more, is not enough to show falsity.”

In a 3-0 decision issued September 9, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a three-year-old district court ruling in United States v. AseraCare, Inc. that a Medicare claim for hospice services cannot be deemed false under the False Claims Act (FCA) based on a difference in clinical judgment. This decision – apparently the first circuit-level determination of the “standard for falsity [under the FCA] in the context of the Medicare …

Allscripts Announces $145 Million Preliminary Settlement with DOJ Related to an Investigation of Practice Fusion, a Recently Acquired EHR Company

By Robinson+Cole's Health Law Group on Posted in Academic Medical Centers, Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Healthcare Technology, HIPAA, Hospitals and Health Systems, Medicare and Medicaid, Privacy and Security, Reimbursement, Stark Law

In its second quarter Securities Exchange Commission (SEC) filing, Allscripts addressed its announced agreement in principle with the Department of Justice (DOJ) to resolve investigations into certain alleged practices of Practice Fusion, an electronic health records (EHR) vendor acquired by Allscripts in February 2018 for $100 million. Allscripts indicated the agreement is still subject to further negotiation and government approval, and would likely include additional non-monetary terms, including a deferred prosecution agreement, if a finalized settlement is reached.…

DOJ Intervenes in FCA Suit Against Spinal Device Manufacturer and Senior Executives that Allegedly Paid Kickbacks to Surgeons

By Conor Duffy on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medical Devices, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement

In a complaint filed on July 22, 2019, the U.S. Attorney’s Office for the Southern District of New York (DOJ) intervened in a qui tam False Claims Act (FCA) suit against Life Spine Inc. (Life Spine), and senior executives of Life Spine. DOJ alleges that the company – a maker of spinal implants, devices and equipment – offered and paid kickbacks in the form of consulting fees, royalties, and intellectual property acquisition fees to surgeons to induce the use of its products in violation of the Anti-Kickback Statute (AKS). DOJ …

DOJ Enters into $225 Million Settlement with Opioid Manufacturer to Resolve Criminal and Civil Investigations

By Conor Duffy on Posted in False Claims Act, Fraud and Abuse, Government Enforcement, Office of Inspector General, Pharmaceuticals and Biologics

On June 5, 2019, the Department of Justice (DOJ) announced a global settlement with Insys Therapeutics (Insys) that preliminarily resolves criminal and civil cases against the opioid manufacturer in a number of jurisdictions. Under the terms of the settlement, Insys agreed to pay a total of $225 million – $195 million in civil remedies and $30 million in criminal restitution (comprising a $2 million fine and $28 million in forfeiture). In addition to the monetary penalties, Insys entered into a five year deferred prosecution agreement with DOJ, as well as …

U.S. Supreme Court Clarifies Scope of False Claims Act Statutes of Limitations

By Melissa (Lisa) Thompson and Conor Duffy on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement

In a unanimous decision issued on May 13, 2019, the U.S. Supreme Court sought to resolve lingering confusion over the statute of limitations under the False Claims Act (FCA) for qui tam suits in which the federal government declines to intervene. In Cochise Consultancy, Inc. v. United States Ex Rel. Hunt, the Court held that a relator’s claim may be brought within 3 years after the government was made aware of underlying material claims, even where the government did not intervene in the case, because 10 years had not …

Seeking to Incentivize Self-Disclosures, DOJ Issues Guidance on Credit for Cooperation with FCA Investigations

By Conor Duffy on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals, Reimbursement

On May 7, 2019, the U.S. Department of Justice (DOJ) provided important new guidance addressing cooperation credit that may be available to defendants in False Claims Act (FCA) investigations (Guidance).  The Guidance – issued in the form of an update to DOJ’s Justice Manual – explains how defendants in an FCA investigation may be awarded credit by DOJ for certain disclosures, cooperation, and remedial activities.

The Guidance is intended to incentivize companies and individuals to (i) be forthcoming with the government upon discovery of potential FCA violations, (ii) aid ongoing …

Massachusetts Reaches $10 Million in Settlements Tied to Medicaid Billing for Home Health Services

By Conor Duffy on Posted in False Claims Act, Fraud and Abuse, Government Enforcement, Home Health Agencies, Long Term Care and Nursing Homes, Medicare and Medicaid

On April 30, 2019, the Office of the Attorney General of Massachusetts (AG) announced that it had entered into two settlements totaling over $10 million with home health care companies to resolve allegations of submission of false claims to MassHealth – the Commonwealth’s Medicaid program. The AG entered into an $8.3 million settlement with Avenue Homecare Services of Dracut, and a $2.13 million settlement with Amigos Homecare of Lawrence, to resolve allegations that they billed MassHealth for unauthorized home health services.…

Series of 2019 Enforcement Actions Highlight Continued Federal and State Scrutiny of Health Care Billing in Connecticut

By Conor Duffy on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Long Term Care and Nursing Homes, Medical Devices, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals, Reimbursement

Since the beginning of 2019, federal and state authorities in Connecticut have announced a number of enforcement actions targeting alleged health care fraud in the state. These cases are a reminder to providers of heightened criminal and civil scrutiny of arrangements implicating health care fraud and abuse laws in the state, and also reflect the extensive federal-state cooperation between the Department of Justice (DOJ) and Office of the Attorney General (AG) in investigating fraud and abuse. That federal-state cooperation is part of Connecticut’s Interagency Fraud Task Force, an initiative started …

Group Practice to Pay $1.85 Million Settlement Tied to Allegations of Improper Unbundled Billing

By Conor Duffy on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals, Reimbursement

On February 25, 2019, the U.S. Department of Justice (DOJ) announced a settlement with a urology group practice to settle allegations of False Claims Act (FCA) violations tied to the alleged submission of improperly unbundled Medicare claims. The pursuit and settlement of this FCA suit by the DOJ represents at least the second recent enforcement action targeting allegations of improper unbundled billing of services to Medicare, and may therefore indicate heightened governmental interest in those billing practices. See here for our analysis of the previous unbundled billing case.…

Department of Justice Intervenes in False Claims Act Suit, Adding Reimbursement Consultant Defendant

By Conor Duffy on Posted in Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Hospitals and Health Systems, Medical Devices, Medicare and Medicaid, Physicians and Allied Health Professionals, Reimbursement, Stark Law

On February 19, 2019, the Department of Justice (DOJ) announced that it had intervened in a False Claims Act (FCA) whistleblower suit filed against Arriva Medical LLC (Arriva) and its parent that allegedly involves the submission of false claims for medically unnecessary glucometers, and alleged kickbacks to Medicare beneficiaries in the form of free glucometers and copayment waivers.  This intervention is particularly noteworthy for the fact that in addition to joining the suit, DOJ announced that it was adding a reimbursement consultant used by Arriva as a defendant to the …

Department of Justice Announces Significant False Claims Act Settlements Tied to Electronic Health Records Arrangements

By Conor Duffy on Posted in Accreditation, Department of Justice, False Claims Act, Fraud and Abuse, Government Enforcement, Health Information Exchanges and Electronic Medical Records (EMRs), Health Information Technology, Healthcare Technology, Hospitals and Health Systems, Life Sciences, Medicare and Medicaid, Office of Inspector General, Physicians and Allied Health Professionals, Reimbursement, Stark Law

The Department of Justice (DOJ) recently announced two high-dollar False Claims Act (FCA) enforcement actions involving allegedly fraudulent arrangements tied to the implementation and use of electronic health record systems (EHRs). The respective settlements enable recovery by DOJ of over $100 million, and immediately precede the government’s recent proposal of new rules to promote the interoperability of EHRs. The settlements thus serve as an important reminder of the importance of adhering to federal fraud and abuse laws and regulations as hospitals and other health care providers continue to implement EHR …

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