On December 14, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that contemplates several changes to, and clarifications of, guidance for the Medicare Advantage (MA) program in coverage year 2024.
Judge Chen’s Message to Medicare Advantage Providers: ICD Guidelines Aren’t Suggestions
On November 14, Judge Edward Chen in the Northern District of California issued rulings on the pending motions to dismiss in U.S. ex rel. Osinek v. Kaiser Permanente, granting in part and denying in part Kaiser’s motion to dismiss. United States ex rel. Osinek v. Kaiser Permanente, No. 3:13-cv-03891-EMC, Dkt. No. 223 (N.D. Cal. Nov. 25, 2022). These rulings offer insight into the evolving landscape and permissibility of legal falsity claims predicated on sub-regulatory guidelines.
Background
The United States previously intervened in six qui tam complaints alleging that Kaiser violated the False Claims Act (FCA) by submitting inaccurate diagnosis codes for its Medicare Advantage beneficiaries, resulting in higher reimbursements. Specifically, the government had alleged two different theories of liability: (1) the addition of diagnosis codes to medical records via addenda that did not exist at the time of the visit were factually false; and (2) the addition of diagnosis codes that were unrelated to the patient visit via addenda were factually and legally false, even if clinically accurate.
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SDNY Ruling in Anthem Sends a Signal to Medicare Advantage Litigants
In a decision issued on September 30, Judge Andrew Carter of the U.S. District Court for the Southern District of New York denied Anthem Inc.’s motion to dismiss a government lawsuit filed in March 2020 claiming Anthem submitted inaccurate diagnosis data in conjunction with its Medicare Part C plans that resulted in alleged overpayments in violation of the False Claims Act (FCA).
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Medicare Advantage Plan Highlights Distinction for FCA Purposes between Clinically Inaccurate Diagnoses and Clinically Accurate Diagnoses that Allegedly Violate Subregulatory Guidelines
In a September 2022 filing in U.S. ex rel. Osinek v. Kaiser Permanente, the Kaiser Permanente consortium defendants (Kaiser) highlighted the distinction between clinically inaccurate diagnoses (factual falsity) and clinically accurate but incorrectly coded diagnoses (legal falsity) and its relevance in False Claims Act (FCA) actions.
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COVID-19 Compliance Conversations – Episode II (VIDEO)
As developments related to COVID-19 continue to unfold, Bass, Berry & Sims attorneys are monitoring the situation and providing guidance through a series of video chats entitled, “COVID-19 Compliance Conversations.”
In this episode, Lindsey Fetzer and John Kelly provide a brief overview of compliance considerations related to conducting internal investigations remotely. Watch the video
Increased Oversight of Long-Term Care Facilities Related to COVID-19
Despite the mounting pressures on healthcare entities related to the COVID-19 (coronavirus) pandemic and recent announcements of regulatory waivers and flexibility in particular areas, regulators are still showing interest in the enforcement of federal requirements for life safety and emergency and infectious disease control preparedness for long-term care facilities.
OIG Medicaid Nursing Home Life Safety and Emergency Preparedness Reviews
On March 23, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) updated its Work Plan in response to the COVID-19 pandemic. Please see this post for more information about all of the OIG Work Plan updates. One of the areas that the OIG Office of Audit Services will focus on is Medicaid Nursing Home Life Safety and Emergency Preparedness Reviews.
OIG’s rationale for focusing on this is, in part, because the patient population in long-term care (LTC) facilities is especially vulnerable to COVID-19 and other disease outbreaks. The focus of the audit is LTC facilities’ compliance with federal requirements for life safety and emergency preparedness, as well as 2019 Centers for Medicare & Medicaid Services (CMS) expanded guidance on emerging infectious disease control.
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The CARES Act and Risk of FCA Exposure
The financial relief programs enacted by the Coronavirus Aid, Relief, and Economic Security (CARES) Act stand ready to provide crucial financial support to people and businesses impacted by the novel coronavirus (COVID-19) pandemic and the resulting economic downturn. These new federal programs recognize the scale of the challenges presented by the COVID-19 outbreak.
While decisions made by companies seeking CARES Act or similar relief may not be scrutinized today, we are likely to see a wave of COVD-19-related criminal and civil enforcement actions in the coming months and years. Impacted individuals and businesses should remember that the urgent need for relief does not eliminate the importance of compliance or the likelihood of significant regulatory oversight in the future.
More specifically, applicants for CARES Act relief must certify or attest to certain facts relevant to their eligibility to participate in the CARES Act’s various programs. Because false certifications or attestations potentially expose an applicant to liability under the federal False Claims Act (FCA), it is critical that impacted individuals and entities take reasonable steps to ensure the accuracy of information and certifications contained in any applications for federal aid.
COVID-19 and the False Claims Act
As the impact of the COVID-19 pandemic continues to spread, the federal government is preparing to take unprecedented action to curb its effects on the nation’s health and economy by freeing up federal dollars for private businesses, manufacturers and healthcare entities of all types. But, those receiving these dollars, directly or indirectly, should continue to monitor updates to and maintain compliance with all applicable laws and regulations as this unprecedented economic response comes with heightened scrutiny and potential enforcement and regulatory risk.
DOJ Prioritizes COVID-19 Wrongdoing
On March 16, the United States Attorney General issued a memorandum to all U.S. Attorneys prioritizing the detection, investigation and prosecution of wrongdoing “related to the current pandemic.” Attorney General Barr also issued a press release on March 20 urging the public to report suspected fraud schemes related to COVID-19. Among the schemes, Attorney General Barr encouraged the public to report were any medical providers “fraudulently bill[ing]” tests and procedures.
DOJ Investigating COVID-19 Fraud
As the impact of the COVID-19 pandemic continues to spread, the federal government is preparing to take unprecedented action to curb its effects on the nation’s health and economy by freeing up federal dollars for private businesses, manufacturers, and healthcare entities of all types. But, those receiving these dollars, directly or indirectly, should continue to
DOJ Moves to Dismiss 11 Patient Assistance Services FCA Cases
In a remarkable move, the Department of Justice (DOJ) recently sought dismissal of 11 False Claims Act (FCA) cases, each of which assert that patient assistance services supplied by pharmaceutical manufacturers constitute unlawful kickbacks. The 11 complaints were brought against various pharmaceutical companies by what DOJ described as “shell companies” backed by the National Healthcare Analysis Group, a company formed for the purpose of filing FCA cases. In seeking dismissal, DOJ argued that the suits ran counter to government interests and wasted “scarce government resources.”
According to the DOJ, the 11 lawsuits involved “essentially the same theories of FCA liability” concerning “white coat marketing,” free “nurse services,” and “reimbursement support services.” Specifically, in a motion to dismiss filed on December 17, 2018, in the Eastern District of Texas, DOJ seemingly defended these manufacturer programs noting the government’s “strong interest” in ensuring that “patients have access to basic product support related to their medication, such as access to a toll-free patient-assistance line or instructions on how to properly inject or store their medication.” The government further argued that the allegations “conflict with important policy and enforcement prerogatives” of federal healthcare programs, and asserted that the relators “should not be permitted to indiscriminately advance claims…against an entire industry that would undermine common industry practices the federal government has determined are, in this particular case, appropriate and beneficial to federal healthcare programs and their beneficiaries.”
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