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In a first, the Food and Drug Administration gave the green light to an algorithm designed to help clinicians diagnose autism in young children. Developed by Palo Alto-based startup Cognoa, the software uses questionnaires from parents, clinicians, and home videos to make a recommendation to assist pediatricians with diagnosis. 

The goal is to identify autism spectrum disorder (ASD) earlier. On average, most kids in the U.S. are diagnosed around age 4. 

“Many of these children are waiting for long periods of time before they get in (to a specialist),” Cognoa CMO Dr. Sharief Taraman, a pediatric neurologist, said in a Zoom interview. “This is a really big deal. We have not had a diagnostic of this kind getting market authorization.” 

Taraman said the software uses machine learning to identify “maximally predictive” features from the questionnaires and two short home videos 

Of course, asking people to provide videos of their kids is very personal. He said families have to give permission for videos to be reviewed by video analysts and the physicians involved in their care.

The FDA’s authorization was based on results from a prospective, double-blinded study that compared how well the software performed in helping diagnose autism compared to a panel of clinicians making a diagnosis based on DSM-5 criteria. Cognoa went through the FDA’s de novo pathway for low- or moderate-risk devices that don’t have a predicate. 

It was evaluated on 425 kids ages 18 months through five years, across 14 different sites. Taraman said the company also made a point to recruit a diverse group of patients for the trial, in terms of race, ethnicity, gender, education and socioeconomic status. Currently, girls and minorities are often diagnosed with ASD at a later age. 

According to the FDA, Cognoa’s test yielded a false positive result in 15 out of 303 kids in the trial without ASD. Meanwhile, it yielded a false negative in just one of the 122 kids with ASD. 

In cases where there wasn’t a clear diagnosis or a rule-out, the algorithm gave an indeterminate result. In total, it provided a diagnosis for about 32% of patients in the trial. 

Having the ability to give an indeterminate result was important, Taraman said, that way the algorithm wouldn’t yield too many false positives, or overlook kids who have other neurodevelopmental conditions that need to be addressed. 

“Technology’s always a tool. It should never be a replacement for a clinician,” he said. “The test is not meant to be a standalone.”

 Cognoa plans to begin marketing the software, called Canvas Dx, later this year. 

“Autism actually is a beautiful thing,” Taraman said. “Our goal is not to ‘turn off’ autism; our goal is to address challenges that come with autism.” 

Photo credit: DrAfter123, Getty Images

Palo Alto, Calif., based Intapp, a major provider of cloud-based business applications for larger law firms and financial services firms, filed papers Friday with the U.S. Securities and Exchange Commission for a proposed initial public offering of its common stock.

For the legal technology industry, where IPOs have been few and far between, the news is significant. Although it is becoming increasingly common for legal technology companies to talk of plans for future IPOs, few have actually completed them.

iManage went through an IPO nearly 20 years ago, in 2002. In 2019, KLDiscovery became a public company. In 2015, AppFolio, which then owned practice management platform MyCase, went through an IPO, but its primary products were not in legal, but in property management.

In February 2019, the ALSP Axiom said that it was preparing for an IPO, but later abandoned that plan and instead said it had entered into an agreement with private equity firm Permira under which a company backed by Permira would take a significant investment in Axiom.

With regard to Intapp, the number of shares to be offered and the price range for the offering have not yet been determined, the company says. It intends to list its common stock on the Nasdaq Global Market under the ticker symbol “INTA.”

J.P. Morgan, BofA Securities and Credit Suisse will act as lead book-running managers for the proposed offering, with Piper Sandler and Raymond James acting as joint book-running managers. Oppenheimer & Co. Inc., Stifel Nicolaus & Company and Truist Securities will act as co-managers for the proposed offering.

Last month, Intapp announced that it had signed an agreement to acquire Repstor, creator of Microsoft 365-based enterprise content management and team collaboration tools.

Last October, Intapp made news when it announced that it would no longer support on-premises technology and shift entire to the cloud, a move I described as “another nail in the coffin of on-premises legal software.”

In its SEC filing, Intapp describes itself as “the industry cloud for professional and financial services firms.” Its 1,600 customers include 96 of the top 100 law firms and seven of the top eight accounting firms, it says.

Its total revenues for 2020 were $186.9 million, an increase of 30% over the prior year, and its total revenues for the nine months ended March 31, 2021 were $153.4 million, an increase of 10% over the same period for 2020.

The University of Miami abruptly fired Dean Anthony Varona of the law school a couple weeks ago and left utter chaos in its wake. In the immediate aftermath of the unanticipated firing — Varona had three years left on his deal — students, alumni, and faculty spoke out against the decision. The Society of American Law Teachers (SALT) and the Association of American Law Schools’ Section on Minority Groups issued statements condemning the firing. Varona hired Debra Katz to represent his legal interests going forward.

So everything’s going great down there, folks!

The official line from the university is that the school needed a dean “with the required vision and effectiveness of execution to bring the school to new levels of excellence,” whatever that means. Katz has demanded the school retract that statement as defamatory. The university publicly declaring to the job market that a law school dean lacks the “vision and effectiveness” to be a dean? Sounds awfully close to telling the world he’s bad at his profession based on some inside information you have as his former employer. This is why sports franchise owners use phrases like “different direction” even when coaches are fired for finishing last. There were also some vague allegations that Varona failed to meet fundraising expectations. Faculty noted that the school is on fine financial footing.

Not smoothing anything over with that pitch. Could it get any worse for the university? Glad you asked!

The AALS section letter went further:

The need for independent and credible investigation is urgent and vital,
particularly given the patently pretextual reason proffered by President Frenk; the current political climate of Florida; and Dean Varona’s identity at the intersection of constitutionally- and statutorily protected groups, including inter alia his homosexuality and Hispanic (Cuban American) ethnicity.

Credible concern that it’s a political if not outright discriminatory firing? The university needs to offer some forthright answers quick.

Friends, the university will not be offering any forthright answers.

TaxProf Blog has an update from a new Miami Herald article detailing a meeting between university president Julio Frenk and law school faculty. Frenk refused to provide an explanation for the firing, saying that he “didn’t find that appropriate.” On the contrary, the faculty thought it was extremely appropriate, indeed required:

Frenk, who was named UM president in 2015, didn’t apologize for not consulting faculty regarding Varona’s termination, a procedure stipulated in the university’s faculty manual. He did say, however, he would stay in touch with the professors as he makes future decisions.

Oh, those rules? We’ll do our best to follow those next time.

And now the university is going to try to hire a new dean from a pool of candidates who have exactly zilch reason to trust the school, to play catch-up on fundraising from an alumni base that’s lodged a protest, with a faculty in revolt, and an angry student body. This should go swimmingly!

As the Herald article says:

Moving forward, some faculty members told the Herald they fear the law school’s negative press could affect the school’s ranking and accreditation.

U.S. News & World Report, which ranks law schools across the country, issues surveys to the legal community, including faculty, judges and lawyers, as part of its rankings. Any negative comments could factor in future rankings.

Perhaps naming the school after a devastating natural disaster hit it on the nose.

Dean of UM law school fired; tenured faculty protest decision [Miami Herald]
Ousted Miami Law Dean Claims University President Defamed Him [Daily Business Review]
Was This Law Dean Fired Because He’s Gay? His Supporters Want Answers [Daily Business Review]
University Of Miami President Doubles Down On Decision To Fire Tony Varona After Less Than Two Years As Dean [TaxProf Blog]

The first week of June has come and gone, and yet another firm has decided to let its employees know what their eventual return to the office will look like. Loeb & Loeb, ranked 99th in the most recent Am Law 100, with $385,271,000 gross revenue in 2020, is the latest firm to announce its reopening plans, and it looks like the five-day, in-office workweek will be a thing the past.

On Friday, Kenneth Florin, the firm’s chair, laid out Loeb’s plans. With a goal of “allow[ing] for as much flexibility as possible,” the firm will start inviting employees back to the office in three phases: after the July 4th holiday, employees can visit the office voluntarily if they wish; after Labor Day, the firm will encourage a “somewhat more meaningful return to office,” which will last “through at least the end of 2021”; thereafter, Loeb will evaluate its new hybrid way of working to figure out what will the future of the firm will look like.

Here are the highlights from each of the firm’s return-to-office phases (memo available in full on the next page):

• Phase 1: The firm will host “fun offerings” on certain days each week to make office visits “more meaningful and enjoyable.” Florin emphasizes that “no one should feel obligated to come in during this time” and that employees “should feel no pressure to do so.”

• Phase 2: The firm will “not be requiring a set minimum number of work days in the office” for attorneys and paralegals; instead, department chairs will arrange a set of guidelines based on department needs, client needs, and individual circumstances. “While we expect many will strive toward an average of 2 or 3 days per week in the office,” Florin notes, “others may make different arrangements which involve them coming in more or fewer days.”

• Phase 3: The firm’s final phase will start in 2022, and leadership will “use everything we learned during our first two phases to inform our longer term plans” concerning a flexible work environment.

Florin closes his message, recognizing that flexibility is key to work/life balance:

[A]lthough we will be returning to the same physical space we left over a year ago, it is clear that our way of working will be very different than what we are used to. But, hopefully, it will be improved, allowing for more flexibility and a work/life balance that works for each of us while maintaining the nurturing culture that is Loeb. I thank you once again for all your patience and diligence as we work to reintegrate everyone in the most comfortable way possible.

Congratulations to Loeb & Loeb on creating a plan that focuses on flexibility in the next normal — one where lawyers and staffers alike will be able to work remotely as suits their individual needs.

(Flip to the next page to see the full memo from Loeb & Loeb.)

What has your firm announced as far as a reopening plan is concerned? The more information is out there, the more likely it is that firms will be able to establish a market standard for a return to work.

As soon as you find out about the reopening plan at your firm, please email us (subject line: “[Firm Name] Office Reopening”) or text us at (646) 820-8477. We always keep our sources on stories anonymous. There’s no need to send a memo (if one exists) using your firm email account; your personal email account is fine. If a memo has been circulated, please be sure to include it as proof; we like to post complete memos as a service to our readers. You can take a photo of the memo and attach as a picture if you are worried about metadata in a PDF or Word file. Thanks.

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Staci Zaretsky is a senior editor at Above the Law, where she’s worked since 2011. She’d love to hear from you, so please feel free to email her with any tips, questions, comments, or critiques. You can follow her on Twitter or connect with her on LinkedIn.

Dear FBI:

I know you were somehow caught flatfooted on January 6. For some reason, I knew there was going to be trouble on that day, but you didn’t. I figured I’d write you this letter because I again see trouble coming, and I just want to be sure that you don’t miss it.

Donald Trump is likely to be indicted somewhere this summer or fall. He might be indicted in New York; he might be indicted in the District of Columbia; he might be indicted in Georgia. But it’s pretty darned likely that an indictment is coming. Assume, for the sake of argument, that the indictment is handed down in New York.

Donald Trump will immediately be at the most risk that he’s ever faced in his life.

You’ve seen what Trump has done when he’s at a little risk — when he might be impeached or he might lose an election. Frankly, those threats were small potatoes; the risk was simply being thrown out of office. What do you think Trump is going to do when he’s at risk of being thrown in jail?

Prosecutors, the courts, and all things remotely related to the judicial system are about to come under siege.

Trump has been deplatformed by many social media sites. And I assume that the judge overseeing the criminal proceeding will be intelligent enough to impose a gag order on Trump. That will help a little.

But Trump has an awful lot of loyalists in high places. A mere gag order will probably not be enough to stop the siege. I’m certain people who are close to Trump, and surely some members of the public, and surely some members of the House of Representatives, and perhaps some senators, and perhaps some news networks, are about to launch an attack the likes of which we haven’t seen before.

We’re about to hear that the Manhattan District Attorney’s Office is like the mob in Salem but limiting its hunt to a single Republican warlock. We’re about to hear that the individual prosecutors assigned to Trump’s case are as evil as the day is long. We’re about to hear that the judge hearing the case is corrupt. We’re about to hear that the entire judicial system can’t be trusted. At that point, my imagination runs out, but my imagination has already proven too limited for past events.

So, FBI, imagine more. Don’t be stupid: You must assign a security detail to Cy Vance and whoever succeeds him as the Manhattan District Attorney. You must assign security details to the individual prosecutors who are handling the case against Trump. You must assign a security detail to the Manhattan District Attorneys’ office itself. You must assign a security detail to the judge.  You must assign a security detail to the courthouse.

The people who are ultimately selected as jurors in the criminal case must remain anonymous, and those folks might nonetheless need extra security.

You’re in charge of domestic security — and I’m not — but you should think about this more broadly. Will courthouses across American become targets, simply because they’re all part of a corrupt scheme? Judges? Prosecutors’ offices?

I don’t know, but I’m worried. You’re the specialist in this kind of stuff. Be smart.

You weren’t prepared for the recent assault on the legislative branch of government.

That was the warm-up act: Trump was threatened only with losing an election.

This is now the main show: Trump will be threatened with imprisonment.  He’s about to get serious. There’s about to be a frontal assault on the judicial system.

Get ready now.

You can’t see you didn’t see it coming.  I told you so.

Very truly yours,

Mark

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Mark Herrmann spent 17 years as a partner at a leading international law firm and is now deputy general counsel at a large international company. He is the author of The Curmudgeon’s Guide to Practicing Law and Drug and Device Product Liability Litigation Strategy (affiliate links). You can reach him by email at inhouse@abovethelaw.com.

When Hertz shares skyrocketed for no particular reason then known to investing man, it struck upon the not-at-all-unreasonable idea of selling a whole bunch of additional shares. If people were willing to snap up shares of a company mired in pandemic and bankruptcy regardless of what had previously been known as “fundamentals,” why should Hertz itself not benefit from the frenzy? The answer to that question turned out to be, “because the SEC says no.”

* A Republican Congressman was finally served with papers related to a lawsuit over the January 6th Capitol riot after prior attempts failed. Seth Rogen may have served the papers right the first time… [Hill]

* A California lawyer, who allegedly used a cafe to embezzle money, has been sentenced to prison. [San Francisco Chronicle]

* A New York lawyer, who is an associate at Dechert LLP, appeared on Jeopardy! last week. [Brooklyn Eagle]

* Jerry Falwell, Jr. is asking that a lawsuit filed by Liberty University over Falwell’s departure from the school be dismissed. [NBC News]

* The Supreme Court is being asked to decide whether America’s all-male draft is unconstitutional. Maybe the movie RBG will be quoted in the briefs… [Fox News]

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Jordan Rothman is a partner of The Rothman Law Firm, a full-service New York and New Jersey law firm. He is also the founder of Student Debt Diaries, a website discussing how he paid off his student loans. You can reach Jordan through email at jordan@rothmanlawyer.com.

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Olga V. Mack is the CEO of Parley Pro, a next-generation contract management company that has pioneered online negotiation technology. Olga embraces legal innovation and had dedicated her career to improving and shaping the future of law. She is convinced that the legal profession will emerge even stronger, more resilient, and more inclusive than before by embracing technology. Olga is also an award-winning general counsel, operations professional, startup advisor, public speaker, adjunct professor, and entrepreneur. She founded the Women Serve on Boards movement that advocates for women to participate on corporate boards of Fortune 500 companies. She authored Get on Board: Earning Your Ticket to a Corporate Board Seat and Fundamentals of Smart Contract Security. You can follow Olga on Twitter @olgavmack.

Though a federal law prohibiting health insurers from discriminating against people with mental health and substance abuse issues has been in place for more than a decade, enforcement can be a challenge. But amid a pandemic that has significantly worsened these issues, regulators at the national and state levels say they are focused on safeguarding insurance coverage parity now more than ever.

In a webinar last week hosted by mental health organization Inseperable, U.S. Labor Secretary Marty Walsh outlined the ways in which his department is working to enforce the Mental Health Parity and Addiction Equity Act of 2008,

The law prevents group health plans and health insurance issuers from imposing less favorable limitations on mental health and substance use disorder benefits as compared to medical/surgical benefits. For example, prior to the law’s passage, health insurers could charge higher copays or deductibles to those with documented behavioral health issues and apply stringent treatment limitations, including on the types of facilities patients with these issues could visit.

To uphold the law and ensure parity in coverage, the labor department has two strategies in place, Walsh said.

The department’s Employee Benefits Security Administration agency has created a task force that focuses on enforcement of the act, he said. The task force is reviewing its inventory of case files, looking to identify potential violations and send out requests to payers for data on parity analyses, which they are required to maintain to show their compliance with the law.

Further, the Department of Labor, along with other government agencies involved in this work such as the Department of Health and Human Services and Internal Revenue Service, is providing regular reports to Congress on their findings and enforcement actions, Walsh said. This can help inform legislation on insurance coverage moving forward.

“From day one, after I got sworn in, I emphasized that our enforcement in the [parity] arena needs to be a priority,” Walsh said. “Group plans and insurers have to be able to show their work if they are claiming to meet parity requirements.”

But enforcement cannot be at the federal level alone. States also play a key role in ensuring that people with mental health and substance use problems do not get the short end of the coverage stick.

On the ground, access to care is still a major issue for those with these disorders, said Ann Marie Sullivan, mental health commissioner of New York, during the virtual discussion. Many insurers require multiple treatment plans before signing off on treatment and provide narrow networks for psychiatrists and other professionals specializing in behavioral health and addiction medicine.

To counter these actions, New York regulators have taken a comprehensive approach to enforcement, Sullivan said. Government plans must work with the state on both the quantitative limits on mental health and substance use disorder benefits, such as caps on inpatient stays, and non-quantitative limits, like medical necessity criteria, which was the subject of a major lawsuit against an insurer two years ago.

In 2019, a federal judge ruled that United Behavioral Health, a subsidiary of UnitedHealth Group, illegally denied mental health and substance use disorder treatment coverage to members using internal criteria that was too restrictive. The payer was ordered to reprocess about 67,000 coverage claims.

Sullivan believes the government needs to step in and oversee the development of that criteria. In New York, all payers providing mental health and substance use disorder benefits must submit their medical necessity criteria to the state for approval.

“You have to change the culture of the [health] plan,” Sullivan said. “You have to say to a plan, look at how you are treating mental illness and substance use the same as medical [illness].”

Strengthening oversight is just one piece of the enforcement puzzle, however. Regulators further need to create a pathway for the public to bring forward coverage issues, Sullivan said. New York created an ombudsman program, called the Community Health Access to Addiction and Mental Healthcare Project, to help residents access their insurance benefits for substance use disorders and mental health services and resolve denials.

“The key thing here is a comprehensive approach,” Sullivan said. “You can’t just take one or two points — you have to look at the whole approach to parity. You have to look at all the things that can interfere with [people] getting the care that they need.”

Photo: AndreyPopov, Getty Images