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Legal Insights and Perspectives for the Healthcare Industry

In a recent LawFlash, our colleagues in the white collar practice discussed the US Department of Justice’s (DOJ’s) Criminal Division’s update to its Evaluation of Corporate Compliance Programs guidance, which is used by its prosecutors to assess the adequacy and effectiveness of corporate compliance programs in corporate criminal resolutions. The updated guidance retains nearly all of the language and questions contained in the previous guidance released in April 2019, but the new update provides clarifications and refinements in key areas, including with regard to access to compliance-related data. Healthcare companies may be interested to review the recent updates that provide insights and useful clarification that can aid legal and compliance departments.

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Authors’ Note: In what may be emblematic of the legal landscape in the time of coronavirus (COVID-19), after we finalized the blog post below for publication regarding the US Department of Health and Human Services updates to the HHS FAQs relating to the CARES Act Relief Fund payments made by HHS on May 19, the agency later added or updated its FAQ on the night of May 20, with some notable changes. These updates have been included (and emphasized in italics) in this republication.

With just days left until provider attestations are due related to acceptance of CARES Act Provider Relief Funds, the US Department of Health and Human Services (HHS) has recently been updating its FAQs, providing some additional clarity, and potentially confusion, surrounding the acceptance of Relief Funds from its initial tranche $30 billion of General Distribution payments. Attestations for the first tranche of payments on April 10 are due May 25, and HHS continues to furnish guidance regarding the details of the General Distribution Relief Fund.

While US healthcare institutions are poised to respond to any outbreak of the 2019 Novel Coronavirus (2019-nCoV), how should they prepare as employers for the questions and compliance challenges that arise in a public health crisis? In this LawFlash, our Labor, Employment, and Benefits team cautions that “employers must carefully balance concerns relating to employee and public safety with protecting employees from unnecessary medical inquiries, harassment, and discrimination—all while complying with immigration, leave, and medical privacy laws.”  Recommending that “[r]esponsibility should be assigned to specific individuals or teams to assess the hazard, communicate with employees and the public, and implement appropriate security measures,” they detail important information that employers should know before responding to an outbreak situation.

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Check out our Responding to the 2019 Novel Coronavirus page for all of the latest developments.

In this LawFlash, our white collar litigation and government investigations team unpacks the fiscal year 2019 False Claims Act (FCA) recovery statistics recently announced by the US Department of Justice. At $2.6 billion in recoveries, 2019 marked the 10th consecutive year that healthcare industry recoveries exceeded $2 billion. To that end, the team addresses the largest recoveries involving healthcare and notes that “enforcement, mostly driven by qui tam filings, remains robust.”

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Further strengthening incentives for organizations to self-report potential FCPA violations, the US Department of Justice continued that trend with additional updates to the FCPA Corporate Enforcement Policy announced on November 20. In this LawFlash, our white collar litigation and government investigations team examines the latest updates, which appear modest on their face but could prove significant in practice.

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In what has become the new “normal” in Washington, DC, these days, hospitals and their associations filed a lawsuit today against the US Secretary of Health and Human Services (Secretary) challenging the recent Final Rule issued by the Centers for Medicare and Medicaid Services (CMS) on November 27, 2019, addressing hospital pricing disclosures.

In its complaint, the American Hospital Association, joined by the Association of American Medical Colleges, the Federation of American Hospitals, the National Association of Children’s Hospitals, Inc. (d/b/a Children’s Hospital Association), and three representative hospitals in Missouri, California, and Nebraska (collectively, Plaintiffs), argue that the Secretary issued a Final Rule that (1) is unlawful and in excess of his statutory authority; (2) is a violation of the First Amendment by unlawfully compelling speech; and (3) is arbitrary and capricious, an abuse of discretion, and contrary to law, citing the Administrative Procedures Act (APA).

The government watchdog agencies continue to focus their attention on Medicare oversight of hospice providers, with two recent reports from the US Government Accountability Office (GAO) and the HHS Office of Inspector General (OIG) focused in large part on ways to improve hospice surveys and nursing care oversight deficiencies. These reports, along with a portfolio of other OIG hospice reports, are giving way to renewed focus by the Centers for Medicare and Medicaid Services (CMS) on hospice surveys as well as by Congress, where legislation in the Senate (and soon the House) has focused on providing CMS with additional hospice survey tools. Proactive hospice providers will do more than take notice of these watchdog agency reports—they will also compare their practices with the critical findings in these OIG and GAO reports to prepare for what will likely be the future focus of Medicare hospice surveys, whether by state agency surveyors or accreditation organizations.

Price transparency rules impacting hospitals, health plans and third-party payers released by the Trump administration promise to substantially change how health plans, consumers, and providers will interact over the coming years. In this LawFlash, our healthcare industry team unpacks the final rule requiring hospitals to make standard charges public and the proposed transparency in coverage rule requiring group health plans and health insurance issuers to disclose negotiated rates with providers and out-of-network estimates for consumers. Across the industry as a whole, plans and providers alike will have to undertake additional costs to update their current programs, technology, and web pages to comply with the price transparency rules and take on or train personnel to maintain that programming and technology.

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Healthcare is the largest labor market in the United States, employing over 18 million workers. Our labor, employment, and benefits team has compiled a list of hot topics and trends in employee benefits to watch in 2020. Key takeaways addressed in this important presentation include health and welfare preventative care services, fringe benefits, taxpayer identity theft, part-timers and 401k plans, and more.

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New York’s Stop Hacks and Improve Electronic Data Security Act, or SHIELD Act, which makes significant changes to the state’s data breach notification requirements, impacts healthcare organizations that hold computerized data with private information from New York residents. In this LawFlash, our privacy and cybersecurity team analyzes the law’s expanded definition of “private information” and offers key business takeaways for assessing compliance with the SHIELD Act, which becomes effective October 23, 2019.

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