Wendy Feldman

'Deny, deny, deny!' That's how a staff doctor at Cigna was told how to review health insurance claims. If you have a health insurance claim that has been denied, you are not alone. Kantor & Kantor, LLP can help. We have attorneys who specialize in appealing and litigating health insurance denials. #healthinsurance #healthinsurancedenials #healthinsurancematters #KantorKantorLaw #expertise https://lnkd.in/gZSd-HDF

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If you have a website, online service, online application, mobile application, or connected device, or a portion thereof, that is "primarily directed to minors" or that you actually know is used by minors, wholly or party in the State of New York, what will you need to do, after Gov Hochul signs SB 7695 NY Child Data Protection Act into law: Your service is deemed to be "primarily directed to minors" also in cases where you have actual knowledge that the service is collecting personal data of users directly from users of another website, online service, online application, mobile application, or connected device primarily directed to minors. You can't collect or allow a third party to collect information of a minor unless: 1) for 12 and under - the processing is permitted by COPPA 2) for 13 and over - the processing is strictly necessary for: providing the requested service and things like: protection against fraud, detection of errors, compliance with law or law enforcement, vital interests - and also internal business operations BUT excluding: marketing, advertising, research and development, providing products or services to third parties, or prompt-ing users to use the website, online service, online application, mobile application, or connected device when it is not in use 3) for 13 and over - with informed consent obtained either through a device communication or signal or through a request. For this you need: 🔹 separate consent 🔹 say that it's not strictly necessary 🔹 not use dark patterns 🔹 clearly present an option to refuse as the most prominent option. 🔹 once given - consent is revocable 🔹 You can't degrade the quality of the service due to refused consent 🔹 You can't sell data of minors. 🔹 If you find out it's a minor you must, within 30 days: (1) delete any personal information you have (2) direct your processors to do the same (3) inform your third party operators that this is a minor Before sharing any personal information of minors with a third party operators: 🔹 You must tell them that your website is directed a minors / the personal data is of a minor (covered user) 🔹 Need a data sharing agreement in place that requires: processing pursuant to instructions; return/deletion of the data; assistance with legal obligations; participation in assessments; accountability (audit); notify in advance of sharing with processors Signals: 🔹 Treat a user as a covered user if the user's device communicates or signals that the user is or shall be treated as a minor, including through a browser plug-in or privacy setting, device setting, or other mechanism that complies with regulations promulgated by the AG 🔹 Adhere to any clear and unambiguous communications or signals concerning processing that the covered user consents to or declines to consent to 🔹 If a signal is unclear - ask for consent. 🔹 AG enforcement + pending regs 🔹 Effective date: 1 year after becomes law #dataprivacy #dataprotection #privacyFOMO

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Magellan Diagnostics: A Due Diligence Disaster Magellan #Diagnostics, which recently settled criminal charges, is a case study in a due diligence gone terribly wrong. Its conduct was so bad I’m concerned about #DOJ’s settlement resolution here. #LeadPoisoning: LP results from, typically, long-term exposure. Because even “small amounts of #lead…cause serious health problems”, early detection and remediation is critical. Children are particularly vulnerable, making accurate testing essential. Acquisition: Magellan was purchased by Meridien Bioscience in 2016 for $66M, based on sales of $16M (a 4.1 multiplier). In the acquisition announcement, Meridien emphasized that “elevated lead levels can cause serious developmental impairment, especially in young children,” and publicly acknowledged that the “need for…testing and fast remediation…is acute”. Ugly Facts: Magellan’s tests used either venous or fingerstick blood. During 2013-2017, both before and after the acquisition, Magellan “misled its customers and the #FDA about a serious malfunction” that affected Magellan’s devices when used to test venously. Magellan’s fraud “caused…tens of thousands of children” and others to receive “inaccurate[]…results”. Magellan “first learned” of this problem “during the FDA clearance process in… 2013”, but it nevertheless marketed the products. Even after customers later complained about the tests’ accuracy, Magellan lied and said it “had only recently identified” the issue. The gov press release is contradictory on the timing of a disclosure to FDA. It references both 2015 and late 2016. (If it was 2015, FDA failed to act in a timely fashion, and it should be taking a hard look in the mirror.) In 2017, FDA asked when the company discovered the problem, and Magellan lied again, saying that it had been discovered just before disclosure to FDA. A recall followed. Resolution: Magellan entered 2 misdemeanor pleas to resolve “criminal charges relating to its concealment” of the device defects. Magellan will also pay $42M, including more than $9M to “compensate patient victims”, meaning that patients were, in fact, harmed. Magellan remains on a short leash: the resolution also includes a deferred prosecution agreement to resolve felony conspiracy fraud charges. Magellan is also obligated to cooperate with the gov, which is involved in an “ongoing prosecution of…former…employees.” Too Easy?: Appreciating that a significant part of the conduct occurred before the acquisition, this conduct involved actual harm to children and repeated lies that impaired FDA’s ability to protect the public, including bad acts post-acquisition. It leads me to seriously wonder if there should have been a felony plea and an exclusion here. Meridien initially paid $66M w/a 4.1 multiplier, but the real cost of this acquisition, w/the $42M paid to the gov, was $106M, at a multiplier of 6.75. It may have gotten off too easy. #labs #compliance #lifesciences #patientsafety

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You know summer is here when a federal court opinion is full of song lyrics related to ice cream and color photos of various flavors. Worth a read. You can tell the judge found a lot of (Good) Humor in the topic. The crux of the case is that plaintiff felt mislead when purchasing Pistachio ice cream from Cold Stone Creamery and later discovered it had no pistachio in it. The court considered whetehr it was fair for the consumer to expect Pistachio Ice Cream to have actual pistachio in it. Some arguments: 1. Cold Stone pointed out that their ingredient list was available online. The court found that unconvincing because the ice cream is being sold in-person. 2. Lots of competitors offering pistachio ice cream actually have pistachio on their ingredient list, thus consumers might expect the same at Cold Stone. The court found a bit of merit in the argument, but weighted it less. In passing, the plaintiff took a dig at Thrifty's Ice Cream and called it "a less premium brand than Cold Stone Creamery." I disagree. Thrifty has good ice cream. Cold Stone has poor quality ice cream. 3. A survey of 400 consumers revealed that 85% expected pistachio to be an ingredient in pistachio ice cream. The court found this to be sufficiently compelling evidence to prevent dismissal of the case. The result: the case will move forward. Some other important learnings. 1. Just because the food does not contain the ingredients you expected, your implied claims of merchantability will fail (in NY) if the food is still edible: "“Where the sale of a food or beverage is concerned, courts have ruled that the product need only be fit for human consumption to be of merchantable quality.”" 2. There is an entire line of cases in NY called "The SDNY Vanilla Cases," litigating about "disaffected purchasers of vanilla products that were derived from substances other than vanilla bean." 2. In the dictionary, "pistachio" is also an adjective - however it refer to the "green colour of the kernel of the pistachio nut," rather than the nut itself.

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What happens as a result of the investigation is not nearly as important as what happens with the person who made the complaint and whether they feel cared about and supported during and after the process. This is also the best approach to reducing risk to the organization. https://lnkd.in/gyxSdJUU

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Is lateral movement down? Not quite.   Sure, Decipher Investigative Intelligence expects lateral partner moves to decrease by 8% and associate moves to decrease by 12%.   But you know what lateral moves are not slowing down?   Moves by partners with a book of business.    "The demand for that type of partner is never going to go away," Decipher Chief Data Officer Greg Hamman.   So develop some business. #DevelopBusiness #BusinessDevelopment #LateralPartner #LateralPartnerMove #BookofBusiness #LegalTrends #DecipherInvestigativeIntelligence

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Tells you all you need to know about non competes. There are other ways to keep workers: compensation, culture, experience, to name a few. So why turn to restraints? "At the time, the FTC estimated that the rule could increase wages by almost $300 billion a year by protecting the 20% of workers who officials estimated are faced with noncompetes, "from hairstylists and warehouse workers, to doctors and business executives."" Read more at: https://lnkd.in/eqPj4Qw6

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A few quick thoughts about the feverish conspiracy speculation.... PS tomorrow, I will have an assassination-related opinion piece in the Wall Street Journal, on a very different aspect of this story https://lnkd.in/gH3nNJdK

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I was going to wait to make this post until I had a blog to link to, but I am too impatient and have too many thoughts. It's been a big year in privacy for New England! In March, New Hampshire signed a privacy bill into law, in April, Maine got pretty close to passing something, and just last Friday (at nearly 1am!), the Vermont legislature passed H. 121, "An act relating to enhancing consumer privacy and the age-appropriate design code." Since the "privacy patchwork" is already taken as a phrase, I will call Vermont's bill a "paper mache privacy law." Vermont is modeled after Connecticut's framework, but goes further in many places and draws inspiration from multiple sources, including Maryland Online Data Privacy Act, the California Age-Appropriate Design Code, and the American Data Privacy and Protection Act. It also includes a private right of action, which I'm sure will be one of the most newsworthy (and controversial) pieces of the H. 121. A few thoughts: 1️⃣ There were parallel efforts in Vermont to pass a comprehensive privacy bill AND an age-appropriate design code (which was S. 289). In the final days, these separate efforts were combined into ONE bill that passed (H. 121). I would characterize the AADC as trimmed down and focused on design/features with requirements on ~data~ in the comprehensive part of the bill. One thing to note is that two duties of care to minors ended up in the bill - one to avoid a "heightened risk of harm to minors" and one that is an affirmative minimum duty owed to minors. 2️⃣ As mentioned above - the private right of action! Vermont residents (starting in 2027) will be able to bring lawsuits against data brokers and "large data holders" for certain, specific violations of the bill. The PRA will sunset in 2029 unless the legislation is passed to continue it. 3️⃣ In addition to the usual consumer rights, Vermont residents will have civil rights protections that resemble what was in ADPPA. Vermont prohibits processing "a consumer’s personal data in a manner that discriminates against individuals or otherwise makes unavailable the equal enjoyment of goods or services on the basis of an individual’s actual or perceived race, color, sex, sexual orientation or gender identity, physical or mental disability, religion, ancestry, or national origin." A caveat to these thoughts is that the final version of the bill is not yet available, and the Governor has not yet been presented with it. There already appears to be a veto campaign in the works, so it's possible he vetoes, but Vermont lawmakers seem confident they have the votes to overturn a veto. Stay tuned for more updates from FPF!

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Whistleblowers claim that Erlanger violated the federal Stark Law, which prevents giving physicians favored treatment, as well as a federal anti-kickback statute. Sullivan and Tabor claim Erlanger filed false insurance claims using the illegal self-referral process to government payers, including Medicare and Medicaid. The lawsuit says the claims were false because the claimants weren't in fact eligible for reimbursement. Why would this matter for patients? In one example, the lawsuit claims one doctor had the highest Contribution Margin for all Erlanger physicians, responsible for bringing in more than $9 million dollars in inpatient and outpatient hospital service fees. Attorneys say that doctor received a reward of more than $1 million dollars for bringing in that much for referrals. The lawsuit says "Erlanger's valuation of referrals from surgeons even trumps patient safety as evidenced by Erlanger's baldly looking the other way in the face of many complaints about the qualify of the [doctor's] surgeries. “Erlanger knew that Dr. [redacted] had on at least two occasions refused to take bleeding patients back into surgery to stop their bleeding because to do so would mar his record, so he transfused those patients with so much blood over a period of hours that he severely depleted the blood supply in the entire Chattanooga area.” The lawsuit says "Erlanger received numerous complaints from other surgeons and medical peronnel about [the doctor] doing unneccessary cardiac surgies and doing poor quality surgeries, but looked the other way due to the value of his referred surgeries to Erlanger's bottom line." Sources say the US government has investigated this case for years. They predict upward of $70 million in settlements if this lawsuit is successful. Profits over patients. #healthcare #healthcarefraud us-beacon.com https://lnkd.in/gpj_zhmb

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The recent Post Editorial. As one friend put it, "They say the quiet parts out loud." #sunlightisthebestdisinfectant #predatory #predatorylending #scams #lawsuitscams #vulnerableplaintiffs #unnecessarysurgeries #justice #conflictsofinterest #ethicalconcerns #ethicalbreaches #publicinterest #nylegislature #governorhochul #nyattorneygeneraljames #usury #civilusury #criminalusury #parasitismandfraud #kickbackschemes #loansharking #bookies #laborlaw #morelucrativethandrugdealing

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If you get health data but aren't covered by HIPAA, take note -- the FTC just finalized changes to the Health Breach Notification Rule, clarifying that the Rule covers health apps (including any app categorized as "Health & Fitness" (!)) and other similar technologies (cough, cough, ad platforms). It also expands the type of information that covered entities must provide consumers when giving notice of a health data breach. Might want to take another peek at your incident response plan... (h/t to Anna Hsia for flagging) https://lnkd.in/g2cj6KUF #law #privacy #infosec

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What to Make of the Most Dramatic Comment Made in #PhRMA’s #IRA Appeal Brian Reid’s great post below cuts to the headlines grabbing one liner from one of the 3 judges that heard the jurisdictional appeal of PhRMA’s #inflationreductionact. But the comment—dramatic as it was—may not be that helpful (at least directly) in charting the path forward in this case. What Was Said: "This is challenging a novel, unprecedented price-setting program in an industry where the government is the 800-pound gorilla ... How would this at all be lawful in any way?" High fives all around, right? Well, it certainly shows that at least one of the three judges on this panel believes the IRA “negotiation” provisions to be unlawful. But Let’s Take a Beat: This appeal really isn’t about the ultimate merits of the case. It’s about whether the district court below had jurisdiction to hear the case at all. Unfortunately, sometimes great substantive claims don’t advance based on procedural defects. Still: The folks at PhRMA have to be pleased, though. They gambled by joining a provider group that is located in Texas to their case, in order to get to the 5th Circuit, a court known for having a low level of tolerance for perceived government overreach. PhRMA was hoping judges there would see the merits of the case sympathetically—so that comment had to be music to PhRMA’s ears. But the addition of that provider group, necessary to file in a court in the 5th, actually GENERATED the jurisdictional arguments that led to the dismissal debated in this appeal. Still, hearing that comment from the bench, PhRMA’s team must have shouted out: “Worth it!” PhRMA and its co-plaintiffs have to get past the jurisdictional question, though. I’ll post more on that tomorrow. Down the Road: Looking down the road to the merits, assuming we get there, there’s both some good—and maybe some not so helpful stuff—dripping off the judge’s comment. The good is quite good—a judge clearly hostile to the “meat” of what’s at issue in this case. But, in legal terms, the comment seems to be pointing to an argument that another judge might have difficulty joining. The comment sounds like the set-up to a “major questions” argument. Under the “major questions” doctrine, the Supremes have said that an agency can’t address an issue of really big, national significance, unless there is very clear Congressional authorization. But I don’t see a “major questions” problem here. The IRA is “novel”, and it is “unprecedented”, but it IS what Congress intended. #HHS and #CMS are RIGHT that #Congress intended a breathtaking revision of the #Medicare program. The core question isn’t whether that is what Congress intended, but whether it is #constitutional. #drugs #pharmacies #drugpricing #drugdevelopment #infusioncenters #pricenegotiation #negotiatedprice #pricecontrols

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Walking our talk - an old but true message about aligning what we say and what we actually do. Be mindful - "carewashing" is a real thing as this article aptly points out: "organizations that claim to have a caring culture must align rhetoric with reality to avoid both external reputational risk and internal operational hurdles, from innovation stagnation and compromised psychological safety to a negative emotional climate rife with cynicism." We don't have to be friends but we do need to be respectful and say what we mean and do what we say. Our colleagues notice & our hearts do too. #ethicsandcompliancematters #ethicswins #walkingourtalk

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I’m a couple days late, but the recent news that the FTC announced a rule banning non-competes to me is a bombshell and I wonder if others have the same impression. Back when I was a practicing attorney, I did a lot of restrictive covenant work (mostly for friends) and even though courts have increasingly disfavored non-competes, it seemed like (certain) employers were trying to impose onerous terms. I think it’s pretty much common knowledge that non-competes have to be reasonable as to scope and duration, but in my personal experience employers seemed to be pushing the boundaries of reasonableness probably under the theory that the court would blue pencil the agreement to make it enforceable. The most onerous term that I saw was a large liquidated damages clause for a violation. And this was for an entry-level position selling fish! And that’s the problem with non-competes is people in entry-level positions or even a little higher lack the leverage to negotiate. Under the FTC rule, non-competes for “senior executives” will continue to be enforceable and I also agree with that. Chiefly, senior executives generally have the leverage to push back and negotiate because the roles and fit at that level are more specific to the individual. When I was an employee of Eastman Kodak and Dow Chemical, I signed non-competes and my agreement at Kodak was actually the most fair one I’ve ever seen. Under that agreement, if Kodak deemed a potential role competitive, Kodak would have paid my salary for the duration of the non-compete. If we had more of those and less of the Fish Company ones maybe non-competes would still be enforceable, who knows. As I said, I’m a couple of days late here, but if anyone has thoughts I’d enjoy hearing them. https://lnkd.in/dVkNPXgm

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I must be living in an alternate reality. The video below is from the Boston Globe, documenting how the Boston Police arrested students at Emerson College last night, this is 20 minutes drive from where I live. I have been watching similar videos from all around the country over the past few days in disbelief. What really broke my heart is the part recorded by young peers watching from an overlooking window. You can hear in the background the screams, cries, and banging on the window in horror, asking for the police to stop even though the police cannot hear them. Perhaps what is worse is reading the comments calling these students "cry babies", laughing out loud at how they panicked, and cheering for the police teaching the demonstrators a valuable life lesson. I could not help it imagine my daughters when they grow up possibly facing such a cruel and surreal reality. I spent more than two decades in the USA studying and working within the higher education systems and experienced two major tragedies: the Virginia tech shooting where tens of students lost their lives including a friend of mine, and the Boston marathon Bombings and subsequent shooting at MIT. Through these tragedies, I saw the power of the local community at both schools coming together to support, care, and love each other. It pains me to see what some of these students go through today. When I was an undergraduate student in Jordan, students at universities frequently engaged in protest in spite of opposition from government and university officials. Even for Jordan in the 90s, with no smart phones or social media, calling the police into a university campus grounds to arrest students was considered a red line that officials could not easily cross without risking a global outcry. Today in America, that does not seem to matter. Not only that we see live streams of police arresting students inside and outside university campuses, but we also witness politicians from both sides of the isle and the majority of mainstream media calling them "mobs" and "terrorists" and pressing on university officials to take extreme measures to shut their voices. This happens while universities continue to fail to even acknowledge the extreme psychological stress many of their students have been dealing with as they witnessed the tragedies unfolding in Gaza for many months, steaming live on social media platforms. I write these words in a state of confusion, loss, grief and despair. What is the meaning of anything we say or do on this platform or other platforms if we are unable to defend the younger generation, its most basic right of self expression, and its capacity to learn and grow. Is there any credibility left for any work we do in higher education? Stand for our students! Stop the arrests, stop the intimidations. Empower our students to speak up for freedom and human rights, many of us won't, or can't.

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