“A federal appeals court said Wednesday it would not reinstate President Joe Biden‘s Covid-19 vaccine mandate for federal employees while it reviews a lower court’s order putting the requirement on hold — potentially setting the stage for the case to go to the Supreme Court,” reports Tierney Sneed in JD Supra.

“The 5th US Circuit Court of Appeals did not explain its reasoning in the unsigned order that said the court was expediting its review of the case. The court said the Biden administration’s request to put the lower court’s ruling on hold was being “carried with the case,” signaling that the appeals court would not rule on the request until it had conducted a fuller review of the case.”

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“Although there are no federally mandated vaccine-or-testing regulations for employees in any industry other than health care, employers still need to comply with state and local rules aimed at protecting their workers from COVID-19. But rather than tracking vaccination status, tests and other precautions internally, many employers are choosing to outsource those efforts to vendors that have emerged to take the onus off of HR,” reports Kylie Ora Lobell in SHRM.

“For example, Ampirical, a 301-employee construction engineering firm in Covington, La., has enlisted the support of Safe Site Check In to manage all COVID-19 procedures, including contact tracing for employees who test positive. Upon arrival at Ampirical’s office, employees and visitors scan a QR code with their smartphone or tablet, then answer six questions and agree to adhere to COVID-19 protocols while they’re onsite, including all construction sites, said the company’s health, safety and environmental manager Rod Courtney.”

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“Pfizer Inc wants to intervene in a Texas federal lawsuit seeking information from the U.S. Food and Drug Administration used in licensing the company’s COVID-19 vaccine, a litigation move that plaintiffs who are suing for the data say is premature,” reports Mike Scarcella in Reuters.

“Pfizer’s lawyers at DLA Piper told U.S. District Judge Mark Pittman on Jan. 21 it wanted a role in the proceedings to help the FDA avoid “inappropriately” disclosing trade secret and confidential commercial information.”

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“An appeals court judge on Tuesday granted a stay in an appeal over mask mandates in New York, keeping the rule in effect during the legal process, New York Attorney General Letitia James said,” reports Kanishka Singh in Reuters.

“A day earlier, a judge had struck down the state’s mask mandate, one week before it was due to expire. The state attorney general had filed a motion to stay the ruling in an attempt to put it on hold while the state filed a formal appeal.”

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“The centrality of law as a public health intervention has been undeniable during the Covid-19 pandemic. In just the first half of 2020, more than 1000 laws and orders were issued by federal, state, and local authorities in the United States in an effort to reduce disease transmission,” discuss Scott Burris, J.D., Evan D. Anderson, J.D., Ph.D., and Alexander C. Wagenaar, M.S.W., Ph.D. in The New England Journal of Medicine’s Perspective.

“Legal interventions include stay-at-home orders, mask mandates, and travel restrictions, as well as more particular rules for business operations, alcohol sales, curfews, and health care. Given their heavy use, importance, and obvious socioeconomic side effects, and the social and behavioral complexities of their implementation, one might have expected the National Institutes of Health (NIH), other research funders, and the research community to jump to the work of determining the right mix, intensity, and enforcement approaches of legal restrictions to control transmission with the least and most equitably distributed harms.”

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“Takeda subsidiary Baxalta has spent more than two years pushing back against the $173 million in damages it was ordered to pay as a result of Bayer’s hemophilia patent infringement lawsuit. But after an appeals win for Bayer in March, the companies are putting the case to rest,” reports Noah Higgins-Dunn in Fierce Pharma’s Pharma.

“The two drugmakers, along with Nektar Therapeutics, have entered into a settlement agreement over the patent infringement case, a court filing shows. Bayer will not seek claims for the many millions in damages it was owed under a 2019 verdict and a subsequent appeals ruling.”

“Under the latest settlement, each drugmaker will cover their own legal expenses and Baxalta will give up its right to appeal the 2019 verdict any further. The filings didn’t provide other details on the terms of the settlement.”

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“As vaccine proliferation continues, employers are preparing to welcome their workforces back to offices and job sites across the country,” write Katharine O. Beattie Sara J. Higgins in Foley & Lardner’s Insights.

“While many Americans are eager to return to pre-pandemic life, employers can expect resistance from employees recalled to the office, particularly from those whose medical conditions put them at greater risk for complications from COVID-19. Reviewing best practices under the Americans with Disabilities Act (ADA) and guidance from the Equal Employment Opportunity Commission, this post provides employers with tips for engaging in an effective interactive process with employees seeking disability accommodations for risks associated with COVID-19.”

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“Three large law firms have agreed to reduce fee applications by $1 million in their bankruptcy representation of Purdue Pharma, the maker of the prescription pain medication OxyContin, after the U.S. trustee alleged a failure to disclose a common interest agreement,” reports Debra Cassens Weiss in ABA Journal’s Verdicts & Settlements.

“The three law firms are Skadden, Arps, Slate, Meagher & Flom; Wilmer Cutler Pickering Hale and Dorr; and Dechert.”

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“Cyber threats and cybersecurity controls have evolved significantly over the past two decades since the HIPAA Security Rule were originally promulgated. During this same time, healthcare entities have increasingly become a prime target of hackers seeking to extort payment using ransomware, exfiltrate patient data to commit fraud, or disrupt operations in other nefarious ways,” write Alaap B. Shah and Patricia M. Wagner in The National Law Review.

“Recognizing these challenges, some security professionals have sought further clarity on the HIPAA Security Rule that they deem to be ‘long in the tooth’. Yet, regulators have not made any significant modifications – perhaps driven by the original policy considerations of the HIPAA Security Rule that: ‘the standard should be comprehensive and coordinated to address all aspects of security’; that it be “scalable, so that it can be effectively implemented by covered entities of all types and sizes’; and that it ‘not be linked to specific technologies, allowing covered entities to make use of future technology advancements.’

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“Area health care providers will finally see millions of dollars in reimbursements tied to a defunct health insurer – but some may be out more than half of the dollars they were owed,” reports Tracey Drury in Business Journal’s Health Care.

“The State Department of Financial Services this week announced a $220.8 million judgment resolving a lawsuit filed in late 2017 against the federal government tied to the collapse of Health Republic Insurance of New York.”

“According to DFS, area hospitals and physicians are expected to recoup the full value of unpaid claims. Here’s what wasn’t in the press release: Providers around the state who didn’t know the settlement was in the works signed offers from Riverdale Capital, a New York-based investment firm for pre-payments of 40 cents on the dollar and are now bound by that agreement.”

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“The anniversary of COVID-19 shutdown orders brought an upturn in both the number of business-interruption lawsuits against insurers and the amount of damages they are claiming,” writes Jim Sams in Claims Journal.

“In the past month:

• A New Jersey hospital system, RWJBarnabas Health, sued Zurich American Insurance Co. seeking $2.5 billion in damages from a virus that sickened 1,000 patients and killed nine staff members.
• Caesers Entertainment filed suit against 60 carriers seeking $2 billion in damages caused by restrictions at its Las Vegas resort casino. The company said it paid $25 million in premiums for $3.4 billion in coverage through a variety of “all-risk” policies, most of which did not include virus exclusions.
• Denison University, Kenyon College, Ohio Wesleyan University and the College of Wooster filed suit against their 16 insurers seeking $1.2 billion in coverage. The consortium of private colleges say their insurers turned their backs on them after the virus made their facilities unsafe and uninhabitable.”

“Also, some of the recent filings were made by groups of businesses against a single or multiple insurers. For example, on March 16, six restaurants and a fitness center in New Jersey filed a class-action suit in Bergen County Superior County against six carriers. On the same day, 26 Ohio dental practices filed suit against Amco Insurance Co. in the U.S. District Court in Toledo.”

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“The information blocking provisions of the 21st Century Cures Act officially went into effect this week, putting into focus the Department of Health and Human Services’ regulatory and compliance effort around HIPAA-required data sharing between applicable healthcare entities,” writes Jessica Davis in Health IT Security.

“Enacted by the 21st Century Cures Act in 2017 and implemented by a final rule in 2020, Congress defined information blocking and established penalties for providers that engage in practices that interfere with the access, exchange, and use of electronic health information.”

“The long-awaited info blocking provision established rules and penalties for non-compliance. The law carves out exclusions for providers if they meet an exception established by the HHS Secretary, or for other applicable reasons.”

“Starting April 5, relevant covered entities and business associates must comply. The Office for the National Coordinator recently released insights on just what the law’s enactment means for those relevant providers, as well as the areas HHS will focus on in the next 18 months.”

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“Purdue Pharma LP has floated a settlement plan calling for members of the billionaire Sackler family to pay more than $4.2 billion to help resolve the thousands of lawsuits that drove the maker of OxyContin opioid painkillers into bankruptcy,” report Jeremy Hill and Jef Feeley in Bloomberg Law’s Bankruptcy Law.

“Court papers filed late Monday by Purdue call for the drugmaker to hand over the company’s assets to trusts for the benefit of states, cities and counties suing to recoup billions spent dealing with the U.S. opioid crisis. Combined with the cash payment by the Sacklers — the company’s current owners — the Chapter 11 reorganization plan may be worth more than $10 billion, according to court filings.”

“In exchange for the company and the cash, slated to be paid out over nine years, Purdue and the Sacklers would be legally insulated from existing and future opioid lawsuits. Some states, cities and counties that sued the drugmaker oppose the proposal, arguing it doesn’t do enough to hold Purdue’s owners accountable.”

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“Novartis AG announced Friday that its global head of litigation, Thomas Kendris, will on an interim basis succeed its outgoing chief legal officer Shannon Thyme Klinger,” reports Brian Baxter in Bloomberg Law’s Business and Practice.

“Novartis said in a statement that Klinger will depart the Swiss drug giant March 15 to return to the U.S. and take a job at ‘a biotechnology company.’ Novartis didn’t identify the company and declined to discuss Klinger’s new role. Klinger didn’t respond to a request for comment on the matter.”

“Her move is the latest in a series of comings-and-goings by law department leaders working for biotechnology startups, drug developers, and medical equipment manufacturers. The health care, life sciences, and pharmaceutical sectors have been busy hiring lawyers within the past year, in part due to the increased demands on some companies stemming from the coronavirus pandemic.”

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“As of February 2021, pursuant to the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), which created the Paycheck Protection Program (“PPP”) and supplemental funding such as the Families First Coronavirus Response Act, the United States government has made available an estimated four trillion dollars in relief funds to businesses and individuals, and the Biden administration is proposing roughly two trillion dollars more,” write Merle M. DeLancey Jr. and Craig Stetson in Blank Rome’s Government Contracts Navigator.

“In addition to the relief funds, the Government has easily awarded more than billions in pandemic-related contracts for everything from vaccines to PPE to hand sanitizers. These levels of funding and spending are unprecedented and have been made at breakneck speed (for the government). Based on these factors and lessons from the past, audits of relief recipients and contractors to confirm appropriate use of government funds are inevitable. And the government has said as much. Of course, if an audit reveals potential wrongdoing or malfeasance, relief recipients and contractors should expect follow-on investigations and enforcement activity.”

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“The first of its kind FCA case involves Roche and Medicare Advantage insurer Humana,” report Mary Inman, Esq. and Max Voldman, Esq. in RACmonitor.

“The recent settlement of a whistleblower case involving the government’s Medicare Advantage program might be a sign of things to come for litigation filed under the False Claims Act (FCA), including those initiated by whistleblowers. On Monday, it was announced that the pharmaceutical company Roche and Medicare Advantage insurer Humana have agreed to pay $12.5 million to the U.S. government to resolve allegations that the companies violated the anti-kickback statute. This is the first FCA settlement resulting from a pharmaceutical company’s alleged payment of kickbacks to a Medicare Advantage Organization.”

“Medicare Advantage, also known as Part C of the Medicare program, is a managed care model wherein the government pays Medicare Advantage Organizations (private insurance companies such as Humana) premiums to insure Medicare beneficiaries. The premium amounts are determined by the demographic makeup and the health status of the insured beneficiaries, with sicker, older members drawing a higher payment from the government than younger, healthier ones. This model contrasts with “traditional” Medicare (Parts A and B of the program), wherein the government pays for each individual healthcare service performed, in what is known as a fee-for-service model. In the Medicare Advantage program, the amounts of government payments are not directly linked to which healthcare services are performed.”

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“The Office for Civil Rights reached a $75,000 civil monetary penalty and corrective action plan with Nevada-based Renown Health, to settle a potential violation of the HIPAA right of access standard,” writes Jessica Davis in Health IT Security’s News.

“The settlement is the fifteenth enforcement discretion brought under the OCR HIPAA Right of Access Initiative since its launch in 2019. The effort is designed to support patients in obtaining timely access to their medical records for a reasonable cost.”

“OCR launched an investigation into Renown Health in February 2019, after receiving a patient complaint that alleged the provider failed to timely respond to their request for an electronic copy of their protected health information. The patient had requested their records, including billing information, to be sent to a third-party.”

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“Sanford Heisler Sharp, LLP announced that Indianapolis-based Roche Diagnostics Corp. and Roche Diabetes Care, Inc. (‘Roche’) and Louisville-based Humana, Inc., Humana Pharmacy, Inc., and Humana Pharmacy Solutions, Inc. (‘Humana’) have agreed to settle a False Claims Act lawsuit brought by a whistleblower relator (‘Relator’) on behalf of the United States. Defendants will pay $12.5 million to settle the government’s claims, and the Relator will receive a 29% share of the settlement, totaling $3,625,000,” posts Sanford Heisler Sharp LLP in GlobeNewswire.

“Sanford Heisler Sharp represents the Relator who filed the case in 2014 in the U.S. District Court for the Northern District of Illinois under the whistleblower provisions of the False Claims Act.”

“The Relator, a former employee of Roche Diagnostics, alleged that the Defendants violated the Anti-Kickback Statute and False Claims Act, causing false claims to be submitted to the Medicare Advantage program and defrauding taxpayers. Medicare Advantage health plans (sometimes called Medicare Part C) are Government-funded health plans that are administered by private companies known as Medicare Advantage Organizations.”

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“As the ever-evolving COVID-19 pandemic is no longer considered ‘unprecedented’ and the restrictions associated with the pandemic have become a part of ‘the new abnormal,’ district courts nationwide are beginning to grapple with the business fears that came to life in March 2020: ‘Will my contract’s force majeure provision protect me when COVID-19 and its consequent regulations prevent me from doing business as usual?'” posts Eversheds Sutherland in their News/Commentary.

“For those in the Southern District of New York, the answer may be ‘yes,’ which brings relief to contractual obligors and dread to contractual obligees. The Southern District’s December 2020 ruling in JN Contemporary Art, LLC v. Phillips Auctioneers LLC sheds light on how COVID-19 could be classified as a ‘natural disaster’ that triggers a force majeure clause. The decision also provides insight into the Southern District’s shift in what constitutes a force majeure, which, for some, could become a contractual quandary.”

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“Global consultancy firm McKinsey & Company has agreed to pay $573 to settle claims by more than 40 US states related to its role in the nation’s opioid epidemic,” report Michael Forsythe and Walt Bogdanich in The New York Times.

“Sources familiar with the matter said that McKinsey’s settlement is with 43 states, the District of Columbia and three territories. Several attorney generals said they planned to make announcements on the opioid epidemic on Thursday, coinciding with the filing of the settlement.”

“$478 million of the settlement must be paid within 60 days, according to the New York Times. In total, the settlement will exceed any profits the firm made from its opioid-related work with pharmaceutical companies.”

“The company will not admit wrongdoing as part of the deal.”

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