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Companies regularly are required to interpret ambiguous and vague regulatory provisions. Today, the United States Supreme Court heard oral arguments in a pair of consolidated cases to determine whether a defendant’s subjective interpretation of an ambiguous regulation is relevant to determining the knowledge (or scienter) element of the False Claims Act or, as the Seventh Circuit held in the case below, that once a defendant can articulate an objectively reasonable interpretation its contemporaneously held subjective belief is irrelevant to the knowledge inquiry. The issue is a significant one for both the government and relators on one side, and potential defendants on the other, as False Claims Act (FCA) liability imposes treble damages and penalties exceeding $20,000 per claim as well as relators’ attorneys’ fees and costs.…

Continue Reading Supreme Court Hears Arguments on False Claims Act Scienter Standard

A. Health Care Providers Benefit from Internet and Social Media Presence.

Electronic medical record software and social media offer wide-ranging ways for health care providers to connect with their patients and the public. Having robust technology offerings support healthcare employers’ efforts to improve clinical integration and value-based care delivery efforts. It also provides greater patient access to healthcare information and engagement with their care team. Internet-based publishing and other social media channels allow healthcare providers opportunities for marketing and for patient education, and may expand access to health information for patients who may not seek regular medical care. There are huge benefits available from these resources for healthcare institutions and providers at every scale and in every specialty, which are likely to continue to expand in the future.…

Continue Reading Tick-Tock – Time for Healthcare Employers to Review Their Internet and Social Media Use Policies!

Inside and outside healthcare counsel should know that the way they guide clients through legal and business issues may need to change based on a recent Ninth Circuit case governing the protections afforded to attorney-client communications, In re Grand Jury.[1] The following update and insights will help you mitigate against the risk of attorney-client emails being produced in litigation:…

Continue Reading Navigating Dual Purpose Communications After SCOTUS (Almost) Weighs in on Attorney-Client Privilege: 5 Practical Tips for Healthcare Attorneys

On February 6, 2023, the United States District Court for the Eastern District of Texas ruled in favor of the Texas Medical Association[1] and vacated portions of the final rule adopted in August 2022 (the “August 2022 Final Rule”) that applied to the Independent Dispute Resolution (“IDR”) process created by the No Surprises Act (the “Act”). [2] The August 2022 Final Rule was adopted by the Departments of Labor, Treasury and Health and Human Services (the “Departments”) and addressed, in part, the specific factors arbitrators must consider in resolving disputes between out-of-network (“OON”) health care providers/facilities and air ambulance providers (collectively, “Providers”), and health insurance plans, under the Act. This is the second time portions of final rules for the IDR decision-making methods have been vacated by this Court as a result of litigation brought by impacted Providers.…

Continue Reading Another Win for Providers: Texas Federal District Court Again Vacates Independent Dispute Resolution Rule for the No Surprises Act

The Food and Drug Administration (the “FDA”) has approved a modification to the Mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) Program, increasing the accessibility of mifepristone for patients with a prescription. [1], [2] …

Continue Reading FDA Approval Mifepristone REMS Program Modification Expands Patient Access to Abortion Care

I was struck on the first day of the 41st Annual J.P. Morgan Healthcare Conference by Sanjay Doddamani (CEO of UpStream Healthcare) saying that “Health is a state of independence.” A simple statement, but a very profound and interesting lens through which to view the Day One Medicare Advantage-focused company presentations. Perhaps it struck a chord in me because, in a flurry of presentations today touting patient net promoter scores (NPS), that simple statement brings to mind the feelings associated with dignity, respect, self-reliance and, perhaps most importantly, choice – concepts that are hard to quantify into a neat NPS number but which we all recognize and understand. Good health indeed does allow us the chance to be independent, while poor health, economic insufficiency and/or aging can force us into dependence, burden and obligation. I don’t have to take a scientific poll to determine which you personally would prefer.…

Continue Reading Day 1 Notes from the 41st Annual J.P. Morgan Healthcare Conference

The New Year energizes us to plan for success in the coming months. To increase the odds of meeting your business goals, we suggest taking a quick inventory of legal risks and brainstorming corrective actions for 2023. While important, legal risks may not seem urgent until a related problem impacts your business (i.e., you are subject to litigation, a business dispute erupts over unclear contract terms, an insurer or Medicare Administrative Contractor notifies you of billing/coding problems, or an employee makes a claim). Once present, legal risks can take a significant amount of time, expense, and energy to resolve that could be spent elsewhere in your business. We recommend taking a few minutes today to ask yourself the following questions:…

Continue Reading Are You Ready for 2023? Here’s a Quick Checklist to Reduce Legal Risks in the New Year

The abortion debate continues in America after the Supreme Court decision in Dobbs v. Jackson and the midterm elections on November 8th. Following our first post in this series, there have been a number of noteworthy developments* that occurred over the past month including several significant events at both federal and state levels as well as recent activity by registered voters during the midterms to protect access to reproductive care.…

Continue Reading Part 2: An Update on the Federal and State E-Roe-sion or P-Roe-tection of Abortion Rights

On Friday, August 26, 2022, the Department of Health and Human Services’ Centers for Medicare and Medicaid Services (“CMS”), the Department of Labor’s Employee Benefits Security Administration and the Department of Treasury’s Internal Revenue Service (the “Departments”) published a final rule updating key regulations pertaining to the No Surprises Act (the “Final Rule”). The Final Rule changes requirements promulgated through prior interim final rules[i] to conform with two rulings by the U.S. District Court for the Eastern District of Texas.[ii] The Final Rule addresses specific disclosure requirements for group health plans and health insurance issuers related to the Qualified Payment Amount (“QPA”) for out-of-network (“OON”) services and sets forth the factors and information which certified Federal Independent Dispute Resolution (“IDR”) entities must consider in arbitrating disputes for OON services or items.…

Continue Reading Final Rule Changes No Surprises Act Requirements

On January 13, 2022, the United States Supreme Court upheld the Centers for Medicare & Medicaid Services (“CMS”) Interim Final Rule (the “Rule”) in a 5-4 decision, staying the preliminary injunctions issued for 24 states by the District Courts for the Eastern District of Missouri and the Western District of Louisiana.  Therefore, the CMS vaccine mandate is in full effect for all states except Texas, which was not part of the cases before the Court.  The Rule requires nearly all workers at Medicare- and Medicaid-certified facilities—whether medical personnel, volunteers, janitorial staff, or even contractors who service the facilities—to be fully vaccinated against COVID-19 unless they qualify for a medical or religious exemption.
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Continue Reading U.S. Supreme Court Lifts Preliminary Injunctions on Healthcare Worker Vaccine Mandate