It has become commonplace to talk about compliance becoming more and more of a challenge amidst the increasing complexities and fragmentation of regulations worldwide. Data protection compliance is no exception. As new requirements continue to mushroom across the globe with escalating frequency and accompanied by heightened repercussions for any failure to meet expected standards, global … Continue Reading
In August, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) introduced a new “Strategic Plan for Oversight of Managed Care for Medicare and Medicaid” (the “Strategic Plan”). The introduction of the Strategic Plan is in response to the continued growth of managed care in government sponsored health … Continue Reading
In April, we previewed two significant False Claims Act (FCA) cases before the U.S. Supreme Court, United States ex. rel. Schutte v. SuperValu, Inc., No. 21-1326 (“SuperValu”), and United States ex. Rel. Proctor v. Safeway, Inc., No. 22-111 (“Safeway”). The FCA provides that “any person who knowingly presents, or causes to be presented, a false or fraudulent claim” to the United … Continue Reading
The Supreme Court recently heard oral argument in the appeal of two False Claims Act (FCA) cases from the Seventh Circuit that called into question the level of intent, or scienter, required to establish corporate liability under the FCA for “knowingly” overbilling the government for goods or services. The Court’s eventual decision may have widespread … Continue Reading
In January 2021, the Centers of Medicare and Medicaid Services (“CMS”) implemented the Price Transparency Regulations (“PTR”) which required hospitals to publish prices for all their services on their websites in a user-friendly format — improving consumer access to pricing information when shopping for health services. Since implementing the PTR, CMS has seen a significant … Continue Reading
Key Takeaway: Organizations must conduct a fact-based analysis to determine whether health data collection and tracking technology deployed on their websites and mobile apps complies with the federal Health Insurance Portability and Accountability Act (“HIPAA”) and other applicable laws and guidance. Cookies, web beacons, and similar technology are used to collect and analyze data about … Continue Reading
The CARES Act requires Medicare providers to attest to multiple certifications. Former prosecutors examine how law enforcement may scrutinize these certifications. Marisa Darden, David Maria, and Thomas Zeno also offer tips on how providers who receive CARES Act funds can insulate themselves from scrutiny.… Continue Reading
One of the more unanticipated consequences of the CoVID-19 pandemic is the rapid shift to telehealth by health care providers. Before the surge of CoVID-19, the Centers for Medicare and Medicaid Services (CMS) limited Medicare reimbursements for virtual services to a narrow set of circumstances, which typically still required the patient to leave his or … Continue Reading
In 2019 the Department of Justice took off its gloves in the opioid fight. For the second time, DOJ has acted to hold opioid distributors and manufacturers criminally liable for contributing to the drug crisis. Read my analysis here in the Anticorruption blog.… Continue Reading
Many may view a C plea to mean a Corporate Plea. Used infrequently, a C plea restricts discretion of a federal district judge to sentence a criminal defendant. When one federal judge expressed his concerns about a proposed C plea for a pharmaceutical company, he changed the result. In an article published by the American … Continue Reading
Let’s hope you don’t pay that much to encrypt electronic Protected Health Information (ePHI). How about a total of $4.3 million over two years? Well, that’s the total penalty for encryption violations assessed by Health and Human Services (HHS). An Administrative Law Judge found the penalty could have been much worse. The facts are sobering. … Continue Reading
The June 13, 2018 publication of Practical Law features a Practice Note co-written by Squire Patton Boggs attorneys Mark A. Salzberg, Elliot M. Smith, John E. Wyand and Sarah H. Stec titled “State Legalized Marijuana Businesses and Access to the Bankruptcy Code”. The Practice Note discusses the federal statutory scheme governing marijuana, its tension with … Continue Reading
In a podcast interview with Healthcare InfoSecurity, Squire Patton Boggs Partner Elliot Golding addresses evolving healthcare privacy and security issues, particularly complex issues involving Internet of Things (IoT) devices. This includes addressing new risks when connected devices link to legacy systems, the applicable regulatory environment, and other key issues companies operating in the health care … Continue Reading
Government uses data mining to select targets for enforcement actions. Your company can use data mining to promote compliance. For tips and insights listen to an eleven minute podcast in “Compliance Perspectives,” from the Society of Corporate Compliance and Ethics (SCCE). SCCE is a member-based association providing education and news updates for ethics and compliance professionals. To listen to the podcast, click … Continue Reading
The 2017 Year in Review of the Department of Justice reveals a Data Analytics Team (the “Team”) for tracking healthcare fraud. The Healthcare Fraud Unit launched the Team in order to provide data mining expertise that efficiently detects healthcare fraud.… Continue Reading
As part of its ongoing implementation of the 21st Century Cures Act (Public Law 114-255), the Department of Health and Human Services last month released a number of new HIPAA guidance tools, including additional information about research uses and disclosures. The research guidance contains helpful tips for covered entities regarding authorizations, revocations, and “reviews preparatory … Continue Reading
Rejecting a contrary holding in the Fourth Circuit, the Sixth Circuit decided a healthcare provider has no “fundamental right to participate in federal health care programs.” Accordingly, the Department of Health and Human Services (HHS) was correct to exclude a pharmacist from federal healthcare programs simply because he was convicted of misdemeanor misbranding.… Continue Reading
Last week a jury awarded millions of dollars to a former General Counsel who brought a whistleblower retaliation lawsuit against a life sciences company. Does that verdict warn the health care industry to brace for a wave of False Claims Act (FCA) litigation brought by in house counsel who have turned relators? Certainly not. General Counsel brought the … Continue Reading
On January 13, 2017, the Food and Drug Administration (FDA) issued a discussion paper on laboratory developed tests (LDT) synthesizing the regulatory dialogue that FDA and stakeholders have had since 2010 and outlining future regulatory possibilities for LDTs. FDA and a majority of stakeholders support a complimentary approach to regulating LDTs that combines FDA’s experience … Continue Reading
Accessories to medical devices play an integral role for their parent medical devices, supporting or adding to the parent device’s functionality. Accessories historically took the classification of the parent device, except in cases where the Food and Drug Administration (“FDA”) classified the accessory in its own right. The 21st Century Cures Act, passed into law … Continue Reading
The Department of Justice (DOJ) announced this week that it collected another $4.7 billion during FY 2016 under the False Claims Act (FCA). This was the third largest haul in history, bringing total recoveries since FY 2009 up to $31.3 billion. Although DOJ did not say it directly, there seems no end in sight to … Continue Reading
On Thursday, CMS announced that it intends to allow providers to “pick their pace of participation” for the first compliance year of Medicare’s new payment reform model emphasizing quality patient care. The start of the first compliance year is January 1, 2017. Thursday’s announcement lays out four options that allow providers more flexibility to comply … Continue Reading
In a move that could affect all hospitals reimbursed by Medicare, the American Hospital Association (AHA) this week renewed strenuous objections to various aspects of ongoing hospital compliance reviews conducted by the Department of Health and Human Services (HHS) Office of Inspector General (OIG). AHA’s most recent correspondence references the “numerous legal defects” it had … Continue Reading
The Centers for Medicare and Medicaid Services (CMS) recently released a proposed rule (the “Proposed Rule”) establishing two physician payment systems introduced by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). These two systems, the Merit-based Incentive Payment System (MIPS) and the Alternative Payment Models (APM), change the way Medicare incorporates quality metrics … Continue Reading
