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Digital health platform Xealth strikes partnership with another big health IT vendor

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Xealth, a startup working to solve some of the logistical challenges faced by digital health companies, struck a partnership with Cerner. The Seattle-based company makes it easier to prescribe digital health tools and integrate them with health record systems.

The partnership is intended to make it easier for patients and their health teams to keep track of engagement with digital health tools and the effect on patients’ health.

“In order for digital health to have lasting impact, it needs to show value and ease for both the care team and patient,” Xealth CEO and Co-Founder Mike McSherry said in a news release. “We strongly believe that technology should nurture deeper patient-provider relationships and facilitate information sharing across systems and the care settings. It is exciting to work with Cerner to simplify meaningful digital health for its health partners.”

Cerner and venture capital firm LRVHealth also invested $6 million into Xealth. Last year, the company raised $14 million in series A funding, with investors including Providence Ventures and the Cleveland Clinic.

David Bradshaw, senior vice president of consumer and employer solutions for Cerner, said the partnership would give patients the opportunity to participate in their own treatment plans.

“Patients want greater access to their health information and are motivated to help care teams find the most appropriate road to recovery,” he said in a news release.

Xealth had already been integrated into Epic, and with this partnership, it will be tied into the two most widely used EHRs. The company is integrated with more than 30 different digital health solutions, ranging from diabetes management platforms such as Omada and Glooko, to Resmed’s connected sleep apnea machines, and patient engagement platforms like Twistle.

One of the startup’s clients, Providence St. Joseph Health, used Twistle in combination with Xealth’s platform to monitor patients with Covid-19 symptoms at home. It helped them keep track of patients’ temperature and oxygen saturation by providing an easy form for them to record their metrics.

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Mental health coaching startup Ginger raises $50M

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Ginger, a digital health startup that lets users chat with a mental health coach, raised $50 million in funding in a series D round. Advance Venture Partners and Bessemer Venture Partners led the funding round, with participation from Cigna Ventures, Kaiser Permanente Ventures, and LinkedIn Executive Chairman Jeff Weiner.

David ibnAle, a founding partner with Advance Venture Partners, and Steve Kraus, a partner with Bessemer Venture Partners, will both join Ginger’s board. To date, the company has raised $120 million.

The San Francisco-based startup connects users with coaches through a text-based chat. They can’t provide the same services as a therapist, but they can send users exercises and encourage them to pursue good sleeping habits and meditation, for example.

For patients who would benefit from more care, Ginger can connect them to a video chat with a healthcare provider. The company contracts with psychiatrists and therapists that then work with its coaches.

Like many telehealth startups, Ginger has seen a surge in visits since the start of the Covid-19 pandemic. In the first week of July, it saw a 125% increase in use of its coaching service compared to its averages before the pandemic.

“The goal of this system is to solve for the supply-demand imbalance that exists in mental health,” Ginger CEO Russell Glass said in a phone interview. “Even pre-Covid, there are far more people that have a need that can access it today. It can take weeks to months.”

The service is currently only available to users whose employer or health plan include Ginger as a covered benefit. The company says it has 200 clients, including Delta Air Lines, Sanofi and Chegg. Its insurance partnerships include Optum Behavioral Health, Anthem California and Aetna Resources for Living.

Ginger was initially created in 2011 by two MIT researchers, Anmol Madan and Karan Singh, who started off with the idea of using cell phone activity to predict users’ mental health. For example, if someone was depressed, they might not communicate with others like they normally do, or their daily patterns of going to the work, the gym or the grocery store might change. Novant Health, Kaiser Permanente and 20 other health systems partnered on this early concept.

Since then, the company has pivoted to focus more on providing health coaching and therapy services.  It still uses information “for proprietary analysis and development of personalized behavioral profiles,” according to its privacy policy.

Ginger is one of a number of startups providing mental health services using digital tools. Competitor Lyra Health raised $75 million  earlier this year, and struck a partnership with Starbucks. And UnitedHealth’s Optum subsidiary was reportedly planning to acquire mental health startup AbleTo for $470 million.

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Whistleblower lawsuit accuses Cigna of Medicare Advantage fraud

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A whistleblower lawsuit accuses Cigna of receiving “billions” in overpayments for its Medicare Advantage plans. The amended complaint, filed by the Department of Justice in the U.S. District Court for the Southern District of New York a year ago, was unsealed on Wednesday.

A former service provider for Cigna’s Medicare Advantage subsidiary alleged that the company sent providers to patients’ homes to conduct a health assessment, which was then improperly submitted to the Centers for Medicare and Medicaid Services for risk adjustment. The whistleblower was a former officer for Texas Health Management, a now-defunct company that worked with Cigna-Healthspring between 2012 and 2017.

Cigna acquired HealthSpring in 2012, and currently offers Medicare Advantage plans in 17 states under this brand.

Commercial insurers who offer Medicare Advantage plans receive a monthly capitated rate from CMS for each of their covered members, which they use to cover the cost of care. For older and sicker patients — who have higher risk scores — they receive a higher rate.

A patient’s risk score is based on diagnoses assigned to the patient in the prior year. To be submitted, a patient must have had a face-to-face encounter with a provider, and the patient must be cared for or assessed.

According to the plaintiff, Cigna ran an assessment program that sent nurses and nurse-practitioners to patients’ homes, where they were expected to see 35 patients per week and generate 20 or more diagnoses per visit. They were reportedly not allowed to provide care, prescribe medications or make referrals to specialists.

The complaint described the program as “…a  data-gathering exercise used to improperly record lucrative diagnoses to fraudulently raise risk cores and increase payments from CMS.”

According to court documents, Cigna-HealthSpring used analytics to sort members into different priority categories based on their medical histories. The company also reportedly sought to recruit primary care physicians to complete the assessments, at one point offering a $150 bonus per completed exam to provider who performed a certain volume of assessments each year

The Department of Justice decided not to intervene in the case in February. Specifically, the government declined to claim that Cigna violated the False Claims Act by conducting nurse home visits that did not involve providing medical treatment.

Cigna did not respond to requests for comment at the time of publication.

This isn’t the first time a Medicare Advantage plan has come under scrutiny for payments.

Last year, the Office of Inspector General reviewed “billions” in estimated Medicare Advantage payments that raised concerns. Looking at 2016 encounter data, the OIG found that Medicare Advantage Organizations almost always used chart reviews to add diagnoses, and that diagnoses reported only on chart reviews — without any service records — resulted in roughly $6.7 billion in risk-adjusted payments for 2017.

Of that, an estimated $2.7 billion in payments were based on diagnoses that did not link to a specific service provided to the member.

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Congress, states hold the keys to telehealth expansion

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An executive order signed Monday directed a swath of federal agencies to expand telehealth services after the pandemic ends. But at this point, much of that work will be up to Congress and state governments.

The directive ordered the Department of Health and Human Services to draft up a policy that would keep Medicare’s expanded telehealth coverage after the Covid-19 pandemic ends, and for multiple agencies to create a plan to improve communications infrastructure in rural areas.

The Centers for Medicare and Medicaid Services, too, announced plans to add more covered telehealth services next year to its proposed Medicare physician fee schedule.

Ultimately, Congress and state legislators will have the final say in shaping what telehealth looks like in the near future.

“I think the administration is pushing as far as they can within reason in terms of making sure (telehealth) is reimbursed and trying to put forward programs to expand infrastructure and access, particularly in rural America,” American Telemedicine Association Director of Public Policy Kyle Zebley said in a phone interview. “But at the end of the day, as helpful as these actions have been, so much of this is going to by necessity require changes in statute and laws passed by Congress to really seal in the changes by industry we’ve had these past several months.”

Since the start of the Covid-19 pandemic, states have rolled out dozens of temporary actions to expand what telehealth services are covered by Medicaid, allow providers who are licensed out-of-state to provide care, and in some cases, require commercial insurers to pay the same for telehealth visits as in-person visits.

At the same time, CMS lifted restrictions, allowing Medicare to cover telehealth visits that take place in patients’ homes, and for a wider variety of services.

The result has been an explosion of telehealth visits, with roughly 10.1 million Medicare patients using telehealth between mid-March and July, according to CMS.

The big caveat, then, is that CMS got the authority to waive these telehealth restrictions through the CARES Act.  Once the public health emergency ends, everything would go back to how it was before, unless Congress gives them the authority to keep some of these changes.

“Congress actually holds the keys to this one because they have those requirements in statute,” Jacob Harper, an associate with Morgan Lewis, said in a phone interview. “The Secretary of Health and Human Services can’t actually override those things.”

There’s already legislation in the works to address this. A House bill introduced last month would give HHS authority to waive or change Medicare telehealth requirements during emergencies “and for other purposes.”

“A lot of this stuff — everyone in the industry would breathe a lot easier if it was passed with legislation,” Zebley said.

But that still leaves two of the biggest remaining hurdles to telehealth to be sorted out: reimbursement and licensing.

 

Two big hurdles

Currently, with the Covid-19 pandemic, Medicare is paying the same for telehealth visits as in-person visits. But in the future, if telehealth makes up a much larger portion of total visits, could that change?

“That’s going to be one of the critical questions that they’re going to have to deal with,” Harper said.

Private insurers have also been grappling with that question. While BlueCross BlueShield of Tennessee was one of the first to say it would expand its telehealth coverage after the pandemic, it hasn’t yet said how much it would pay for those services.

On the state level, there’s been more momentum. While most states already required coverage parity from private insurers, a handful of states added temporary requirements that they must pay the same amount for telehealth as in person visits. And three states — California, Arizona and Washington — have laws that would require payment parity starting in 2021.

That leaves licensing, the main restriction keeping physicians from taking appointments across state lines.

For most states, the solution has been to join the Interstate Medical Licensure Compact, which effectively streamlines the licensing process for physicians who want to work in multiple states. Some of the most populous states, including California, Texas, Florida and New York, are not currently part of the compact. But six states — including New York — have introduced legislation to join the compact.

While it’s a quick solution, it’s still not perfect. The costs add up: on top of the initial $700 to participate in the compact, most states charge more than $300 to practice in their state, with a few charging more than $700.

“I think that could be a mechanism to better this, but the cost of the licensing issue is a tricky one,” Harper said. “Each state has an incentive to protect doctors and personnel who are already licensed through that state.”

The bottom line: while telehealth has certainly seen its moment in the past few months, it will still take a big push from many different entities for the momentum to continue.

“To make this grand experiment really work, I think you need buy in from every stakeholder at some level,” Harper said. “Everyone needs to be on board here and I think just about everyone is.”

 

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Pfizer, BioNTech score deal to supply 120M Covid-19 vaccine doses to Japan

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The entrance to a Pfizer office in Cambridge, Massachusetts

Days after announcing the start of their late-stage clinical trial of a vaccine to prevent Covid-19, a U.S. drugmaker and its German partner are supplying a large number of doses of vaccine to Japan.

New York-based Pfizer and Mainz, Germany-based BioNTech said Friday that they would provide 120 million doses of vaccine from their BNT162 development program, assuming regulatory approval, to Japan’s Ministry of Health, Labor and Welfare, in the first half of 2021. Financial details were not disclosed, and terms were based on timing of delivery and volume of doses, but the companies had signed a deal with the U.S. government to supply 100 million doses of vaccine for $1.95 billion.

The announcement referred only to BNT162, which collectively includes four vaccine candidates. In an email, a Pfizer spokesperson wrote that assuming clinical trial success and regulatory approval, the vaccine in question would be BNT162b2, which is the same vaccine that entered a global Phase IIb/III clinical trial last week. The other lead vaccine candidate is BNT162b1.

Shares of Pfizer were down more than 1.6% on the New York Stock Exchange Friday in late-afternoon trading. Shares of BioNTech were down about 2.5% on the Nasdaq.

“We are deeply honored to work with the Japanese government and to marshal our scientific and manufacturing resources toward our shared goal of bringing millions of doses of a potential Covid-19 vaccine to the Japanese people as quickly as possible,” Pfizer CEO Albert Bourla said in a statement. “In the face of this global health crisis, Pfizer’s purpose – breakthroughs that change patients’ lives – has taken on an even greater urgency.”

The news comes amid the postponement of the 2020 Summer Olympics, which were originally scheduled to take place in Tokyo between July 24 and Aug. 9, but have been postponed until summer 2021 due to the Covid-19 pandemic.

Apart from Pfizer and BioNTech, several other companies are also running late-stage clinical trials of Covid-19 vaccines. These include Moderna’s Phase III trial of mRNA-1273, which like BNT162 is a messenger RNA vaccine, though that study is only taking place in the U.S. China’s Sinovac and British drugmaker AstraZeneca are also running Phase III trials.

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INVEST Pitch Perfect winner spotlight: Luma Health keeps patients connected between visits

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Luma Health’s platform automates scheduling and referrals via text message. Screenshot from MedCity Invest

Often, a painful experience will spur founders to start a new company.

For Luma Health CEO Adnan Iqbal, it was tearing his ACL during a soccer match. He was told that he would have to wait three weeks before he could even get in for an appointment. But after calling in several times, he was able to get in and get to surgery within that week.

Luma Health CEO Adnan Iqbal

He relayed his experience over lunch to his friend and co-founder, who was finishing a radiology fellowship at Stanford. He, too, was facing scheduling problems.

“Patients were waiting five to 10 weeks to see him when he had eight to 10 openings on his calendar,” Iqbal said in a phone interview.

The idea was to create a simple fix to this broken system. Not only would it make for happier patients, but it could also boost health systems, which face unused capacity on a given day.

For most appointments, patients call in, and are told a physician won’t be available for another month or two. Assuming the doctor is busy, patients hurriedly make an appointment. But they’re unlikely to keep it.

“Any patient that schedules more than two weeks in the future is at a high risk of disappearing. Their schedule changes, life changes, they forget to cancel or they’re a no-show,” Iqbal said. “Within a 48-hour window there are such constant changes to a hospital’s schedule and a lot of people fall through the cracks, unfortunately.”

This leaves call centers trying to contact patients to fill last-minute openings, but with mixed results.

Luma’s approach is to send automated text messages to patients that allow them to schedule or confirm a visit just by clicking a link. For example, it can let patients know they’re due for their annual well visit, or that they were referred by their primary care physician for a colonoscopy. Patients receive reminders the day before, including instructions, such as having someone to drive them in for their procedure.

After the visit, it follows up with questions, such as whether the patient is feeling nauseous or light-headed, that can lead to a video visit if needed.

Iqbal said the company sees referrals upwards of 60%, where normally just 15% to 30% of patients follow through with a referral.

The company has been around for five years now, and 16 million patients use its platform. In the last year, the company started to see growing interest in patient engagement platforms, as health systems began to think more about their “digital front door.”

The Covid-19 pandemic only further magnified that, as clinics needed a way to route patients to the right point of care – and fast.

“We started seeing that pull in 2019. Once the pandemic hit, it really accelerated that transformation. It went from a top-five priority to a must-have,” Iqbal said. “It’s been all hands on deck”

The company worked with UC San Diego Health to implement its platform in just eight days. They needed to be able to message a quarter of a million patients on which locations to go to and what services were available.

Luma’s other clients include UCSF Health, public health system Cook County Health and Salud Family Health Centers, a federally qualified health center in Colorado.

In the future, Iqbal hopes to deepen Luma’s work on the clinical side and help stratify patient risk.

“How can we guide them further in the journey than we are able to today?” he said.

 

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CVS builds out digital health program with five more companies

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Last year, CVS Caremark launched a program to make it easier for health plans to implement digital health tools. Since then, it has steadily added a stream of companies to its new Point Solution Management Service, including Livongo, Hinge Health and Hello Heart.

On Wednesday, CVS added another five companies, focused on weight loss and mental health. They include:

  • Daylight, an app to help users manage worry and anxiety
  • Vida, a startup that offers personalized health coaching and therapy
  • Naturally Slim, an online weight loss program
  • Weight Watchers, which has built out its own digital plans
  • And Kurbo, a program designed by Weight Watchers to help children and teens make healthy lifestyle choices.

CVS Caremark CMO Sree Chaguturu shared more about his long-term vision for the program.

“There’s been an explosion of investment and development in digital health applications and solutions,” he said. “But there have been a couple of challenges: how do you know which ones have an impact and are high quality? How do you pay for them? … Those pain points are what we’re trying to address in Point Solution Management.”

Through this model, Chaguturu said health plans can pay for digital health solutions based on how many of their members use a service as opposed to a flat access fee.

Caremark also vets the solutions by looking more closely at their clinical claims and supporting data, as well as conducting a security and business review of each solution.

“We don’t see these solutions as replacing clinical care but as an adjunct and supportive to help patients in self-management,” he said.

Pharmacy benefit managers have recently begun taking a closer look at digital health companies as an adjuvant to traditional medicines. Last year, Express Scripts launched its first digital health formulary, with solutions from Livongo, Omada Health, Propeller and SilverCloud.

Whether these programs will create more widespread use of digital health tools remains to be seen, but it’s a promising first step to help bridge some of the practical gaps toward adoption.

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Kaiser Permanente opens new medical school in Pasadena

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Kaiser Permanente brought in its first class of 50 students to its new medical school this week. Photo credit: Kaiser Permanente

Kaiser Permanente’s new medical school in Pasadena brought in its first class of 50 students.

The Kaiser Permanente Bernard J. Tyson School of Medicine was named after Kaiser Permanente’s late CEO, who unexpectedly died in November.

Plans for the school first began a decade ago and were shared with the public in 2015. The focus was on having smaller-than-usual classes of students, and training students on the managed care organization’s brand of medicine.

The school will waive tuition costs for its first five classes through 2024. Thereafter, tuition is expected to be about $55,000, though students will be able to receive financial aid.

Another unique feature of the school is that students will be able to get hands-on experience starting with their third week of classes. Most medical students begin clinical clerkships in their third or fourth year of school, but Kaiser Permanente says students will be able to care for patients in “longitudinal integrated clerkships” in their first two years.

Some of those plans have shifted slightly with the Covid-19 pandemic. In their third week, students will begin working with simulated patients, but a large portion of this will be able to take place virtually, a company spokeswoman wrote in an email. For classes, the school will opt for a hybrid approach, with some taught in-person and others taught virtually.

SARS-CoV-2 will also be making an appearance in students’ curriculum, with students learning about the biology of virus, the clinical implications of Covid-19, the pandemic in the context of racial and ethnic health disparities, and vaccine development and delivery.

“As our nation grapples with a devastating pandemic, long overdue attention to social injustice, and entrenched disparities in health and health care, we are excited to train students who will become outstanding clinicians and skilled advocates for patients and communities,” the school’s founding dean and CEO Dr. Mark Schuster said in a news release. “I am thrilled about our incoming class as well as the faculty and staff who have come together to participate in their education.”

Prospective students for the school’s second class can submit their applications by October 1.

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StartUPDATES: New developments from healthcare startups

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Vector illustration - Startup

HealCo’s Health System Without Walls (HSWOW) is healthcare’s tele-hybrid solution. Simply put, we’ve merged traditional brick-and-mortar office visits with telemedicine. Here’s how it works:

  • Telemedicine solves many problems in outpatient care, but there are still visits that require physically going to an office.
  • HSWOW tele-hybrid medical offices host licensed providers who supervise all visits remotely, via video call.
  • The brick-and-mortar office is managed by clinical assistants operating at the top of their license

Click this link to fill out a short survey to get involved. Find out more about HealCo at www.healco.us.


Eikonoklastes, a preclinical biopharmaceutical company developing next-generation tissue factor immunotherapies for triple-negative breast cancer, has closed an oversubscribed seed funding round.  Working with The Ohio State University Corporate Engagement Office and seed investor CincyTech, the company was formed to advance technology discovered and engineered in the lab of Dr. Zhiwei Hu, MD, PhD, and licensed from the Ohio State Innovation Foundation. CincyTech led the financing. To read more, click here.


Encoded Therapeutics, a precision gene therapy company, has raised $135 million in an oversubscribed Series D financing. The company’s lead asset, ETX101, was granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation by the U.S. Food and Drug Administration (FDA) for the treatment of SCN1A+ Dravet Syndrome. GV led the funding round  with participation from Matrix Capital Management, ARCH Venture Partners, Illumina Ventures, RTW Investments, Boxer Capital, Nolan Capital, HBM Genomics, Menlo Ventures, Meritech Capital, Farallon Capital Management, SoftBank Vision Fund 2, and additional unnamed investors. To read more, click here.


Health insurance tech startup Sidecar Health raised $20 million in its most recent funding round. Cathay Innovation led the round, which also included new investors Comcast Ventures, Kauffman Fellows and Anne Wojcicki, co-founder and CEO of 23andMe. Returning investors GreatPoint Ventures and Morpheus Ventures also took part in the round. To read more, click here.

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Humana plans to send 1 million home screening kits to its members

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Humana said it will send 1 million test kits to its members to allow them to access preventive screenings at home. The insurer said it would send its Medicare Advantage members at-home colorectal cancer screenings and diabetic management test kits. Humana’s Medicaid members will also have access to the diabetic management test kits.

The effort is an attempt to offset delayed care due to the Covid-19 pandemic. In April, several health systems postponed all elective procedures to conserve protective equipment. While most offices have since begun scheduling appointments again, many patients might not feel comfortable going in just yet.

As a result, routine cancer screenings have plummeted during the pandemic. A report by EHR vendor Epic found that screening appointments in March were down between 86% to 94% compared to mean volumes. This, of course, could have long-term implications for patients if it leads to later cancer detection.

“Because of the pandemic, many of our members – who are primarily seniors – have not been comfortable leaving their homes for routine health care,” Humana CMO Dr. William Shrank said in a news release. “Many interactions with health care providers can be conducted virtually, and we encourage telehealth whenever possible. However, patients and doctors should work together to determine when in-person visits are needed, and we are taking every precaution to make sure those visits are safe and that our members have confidence to make the best decisions for their health. During these complex times, patients should not be distancing themselves from their doctors.”

Humana will offer the at-home screenings until September.

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