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Casey Langwith
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FDA’s de novo premarket review pathway for low-to-moderate-risk devices. In its announcement, the agency noted that it will be establishing “special control” criteria to make clear its accuracy, reliability, and pregnancy prevention effectiveness expectations for this and future contraception apps.

Data supporting the decision included clinical studies of 15,570 users who used the app for an average of eight months. In these, the Natural Cycles demonstrated a “perfect use” failure rate of 1.8 percent, implying that 18 women in 1,000 using app correctly for a year will become pregnant, and a “typical use” failure rate of of 6.5 percent for those occasionally using the app incorrectly.

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over 1 year ago

More than a quarter of the U.S. population — and 28% of seniors — live alone. Social isolation can have serious downstream effects to people’s health, such as raising the risk of heart disease or stroke, and it’s estimated to cost the federal government $6.7 billion a year.

e drive you to the doctor. We help you around the house. We teach you these computers. We engage you with your health. We take you on walks,” says Parker, who cofounded the company with Alfredo Vaamonde and Jake Rothstein in 2017. “We’re really like family on demand

On Thursday, the Miami, Florida-based company announced a $150 million Series D round led by SoftBank Vision Fund 2 that values Papa at $1.4 billion. The company has raised $240 million to date. The interest from investors, which also include TCG, Tiger Global Management, Canaan, Initialized Capital and Seven Seven Six, speaks to the growing recognition that a person’s “health” isn’t limited to the doctor’s office — a combination of socioeconomic factors from access to transportation to distance to a grocery store play a role in long-term healthcare costs. Plus, the federal government changed the rules in 2019 so that companionship and social support services could be reimbursed with Medicare dollars.
Today Papa is contracted with more than 65 health plans to send what the company calls “Papa Pals” into people’s homes. And it’s not limited to seniors — Papa also works with Medicaid plans for low-income families and with employers as a benefit for family caregivers. The typical Papa encounter starts with a phone call, says Parker. If the person agrees, a Papa Pal is dispatched to the patient’s home, where they have a conversation about their needs and offer support with day-do-day activities, like driving to a doctor’s appointment or preparing a meal. During the Covid-19 pandemic, Papa also started offering virtual visits.
“Through that relationship and trust, we're able to really move the needle on whatever is important and whatever gap exists for that member,” says Parker. The pals’ help isn’t limited to errands. They also make notes on issues they might spot within the home, like uneven floor boards or a bathtub with a high rim that could contribute to falls. The member then gets a follow-up call from a member of Papa’s care team who explains how the person could use their insurance for home modification to make it more accessible. Last quarter alone, Parker says pals made 10,000 of these “gap identifications,” which are issues that could help improve the quality of life of the member in their home. The company is also using AI to better prioritize member needs. “We can't solve all problems, but we can identify a lot of them,” Parker says.
“If we can provide companionship and help eliminate some of the loneliness that people are feeling, but, at the same time, pair that with really understanding the home environment … I think these are meaningful levers that can be pulled pretty inexpensively to help improve the quality of life for individuals.”
hile Parker’s motivation to start Papa was inspired by his experience trying to help his aging grandfather, he gets some of his business acumen from having worked alongside his father Randy Parker, who was the founder and CEO of telemedicine startup MDLive. Andrew Parker worked at MDLive as a director of sales and later vice president of health systems before leaving to start Papa in 2017. He teamed up with his cousin Rothstein (who later left to start a senior community living startup) and Vaamonde.
In the beginning, Papa focused on recruiting college students to serve as companions, but as the company has grown, so has the network of Papa Pals. Parker says the company gets around 10,000 to 15,000 applications a month from people of all ages, but only around 8 to 10% actually make the cut. Every pal needs to take a personality test, pass a background check, car screening and social media scan. The around 25,000 pals in Papa’s network earn an hourly rate between $20 to $25 an hour (plus an opportunity for bonuses) and will provide around 500,000 companionship hours this year. Parker says around 20% of Papa Pals fall in the category of pre-med, nursing or social work students, but the vast majority don’t have a background in healthcare. “By removing bathing and toileting, which we do not do, we've now empowered a whole new category of care,” he says.
As of January 1, 2022, Cigna will be the latest major health plan to offer Papa to around 70,000 of its Medicare Advantage and dual eligible members across nine states. The health insurer has been studying the effects of social isolation and loneliness long before the Covid-19 pandemic, declaring loneliness at “epidemic levels” based on its 2018 national survey. When repeated two years later in 2020, Cigna found 61% of Americans reported feeling lonely, a 7-percentage point increase. The expectation is the Covid-19 pandemic will only make things worse.
Right now Papa’s biggest markets include Florida, Texas, Michigan and California, which track with the biggest Medicare Advantage and managed Medicaid markets. Parker says the main goal is to keep contracting with more health insurers to expand the universe of people that Papa serves, especially as the state of the world remains in flux as the pandemic continues. “I don't want to say that Covid was the reason we grew,” says Parker. “I just think that anyone that didn't believe in loneliness, or isolation definitely does now because all of us have experienced it.”

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Saved to havaya
about 2 years ago

• Walmart will provide Transcarent with its everyday low-cost pricing (EDLP) for health services, including prescriptions and health supplies
Today, half of all Americans are covered by employer-sponsored health insurance. According to the Kaiser Family Foundation, in 2020, the average annual premiums for employer-sponsored health insurance were $7,470 for single coverage and $21,342 for family coverage. What’s more, employers have seen costs escalate year after year without corresponding improvements in the quality of care. And while many employers have tackled this challenge head on by offering access to many new and innovative healthcare benefits, employees and their families are often left overwhelmed and confused by a growing list of options that have yet to demonstrate an impact on health outcomes or cost.
“We are committed to providing care to customers and the communities we serve through an integrated, omnichannel approach that improves engagement, health equity and outcomes,” said Dr. Cheryl Pegus, executive vice president of Health & Wellness at Walmart. “Most of America lives within 10 miles of a Walmart, which makes us uniquely positioned to deliver the right care at the right time in the right way. We are proud to bring our size and scale to make it simple to live healthier and leverage our collaboration with Transcarent to reach even more people where they live and work.”

Walmart’s Omnichannel offerings include Pharmacy services – retail and specialty; Optical services, national telehealth services that include a focus on behavioral health, OTC, Walmart health centers and low-cost fresh food. Through this range of services, the company focuses on Social Determinants of Health, personal behaviors and clinical care seven days a week. Walmart provides prescriptions, over-the-counter medications, a variety of immunizations and COVID-19 drive-thru testing in select locations. For those who receive their COVID-19 vaccination at Walmart and Sam’s Club, a Digital Vaccine Record is available for easy access of their vaccination record that can be saved, downloaded or shared with third-party verification apps. Walmart customers with a W+ membership can also get free shipping on store purchases and medicines offered as part of the membership.
The company’s recent launch of ReliOn™ NovoLog® vials and FlexPens®, which will save customers 58% to 75% off the cash price of branded insulin products, demonstrates Walmart’s commitment to improving affordability for chronic disease management. To learn more about wellness resources available at your neighborhood Walmart, visit www.walmart.com/wellnesshub .

Employees and their families will be able to easily engage Transcarent’s Health Guides and extended clinical team for unbiased information, trusted guidance to better understand care options and associated costs, and easy access to high-value virtual and in-person care - either through Transcarent digital offerings, Transcarent’s Centers of Excellence or Walmart’s in-community clinics. Employers have no up-front or per-employee-per-month (PEPM) fees, as Transcarent offers a fully at-risk model. Transcarent also pays health systems up front for surgeries, yet another difference in the model that health care providers love.

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over 2 years ago

Found, a startup focused on weight care management, is emerging from stealth today with $32 million in total funding and the news that it has appointed former Bumble COO Sarah Jones Simmer as its new chief executive.

Found was incubated at Atomic, a San Francisco-based venture studio in the spring of 2020. Earlier this year, it raised $24 million in a Series A round led by GV (formerly Google Ventures) and Atomic, with participation from Define Ventures. And over the course of the last year, it raised $8 million in previously unannounced seed funding, largely from Atomic in addition to Define Ventures

By comprehensive, he means that the startup draws from “dozens” of medications, supplements, diet plans, exercise routines and coaching programs to help its members achieve their personal weight and health goals.

Since its 2020 launch, Found has helped “tens of thousands” of members lose over 200,000 pounds, according to co-founder and COO Swathy Prithivi, who had served as the company’s interim CEO before Jones Simmer’s hiring earlier this month. It is currently available in 31 states at an average cost of $100 per month with a variety of plans.

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over 2 years ago