at-home Testing
FDA says not to use Cue Health's Covid-19 tests
Embattled at-home testing company Cue Health suffered another blow this week when the Food and Drug Administration warned consumers not to use their Covid-19 tests at all for risk of false results.
The company has two Emergency Use Authorizations for two Covid-19 tests — one for point-of-care use and one for home-use — issued in 2020 and 2021. But late last week, the agency charged in a warning letter that Cue had made changes to its tests that FDA had not authorized.
This week's strongly-worded safety communication urges customers to dispose of their test cartridges and to consider retesting if they tested negative.
This is hardly Cue's first hurdle, despite sky-high valuations when it went public in 2021 and high profile federal contracts. As Katie Palmer has reported, the company struggled to deliver on those contracts, and has been forced to undergo several rounds of layoffs. Read more analysis from Brittany Trang here.
teletherapy
Talkspace makes good on Medicare promise
After teasing its Medicare expansion plans during the J.P. Morgan Healthcare Conference in January, virtual mental health company Talkspace is launching today in traditional Medicare across 11 states: California, Florida, New York, Ohio, New Jersey, Virginia, Missouri, Maryland, South Carolina, New Mexico, and Idaho, Mario Aguilar tells us. Talkspace eventually plans to serve all Medicare enrollees across the country, and CEO Jon Cohen said in an earnings call last week that it's in "advanced discussions" to expand to Medicare Advantage for some payers.
As Mario has reported, Medicare represents a gigantic, but largely underserved market. A recent report from the Health and Human Services Department's Inspector General's Office flagged a lack of behavioral health providers serving Medicaid and Medicare beneficiaries.
Still, it's not clear if creating access via telehealth will lead to significant use. On the call, Cohen, and CFO Jennifer Fulk said that while some of the company's long-term guidance reflects the expansion, Talkspace is being conservative in its outlook as it tests marketing strategies.
Another pending question: What happens to a holdover pandemic telehealth flexibility that waives the requirement for in-person visits before virtual counseling? Lawmakers are currently mulling an two-year extension of the policy.
How do therapists really feel about telehealth?
The heaps of pandemic telehealth usage data suggests, broadly, that patients really like virtual mental health care because of its convenience. But a new report from non-profit research institute Data & Society aims to shed light on therapists' views — and it's a mix of optimism and frustration. Despite affordable and on-demand visits for patients, "therapists describe the reality of such platform work — including fractured schedules, constant client turnover, and unpredictable payment structures — as exploitative of their labor," the report says.
"By restructuring the labor of therapy, platforms formalize powerful assumptions about the work of therapy," the report notes, including "that therapy can be done anywhere, that therapy can be scheduled anytime, that therapy can be algorithmically mediated, that therapy can be reduced/diluted to forms of emotional support, at times via text, and that therapists are in endless supply. These assumptions have important implications for the present and future of therapy for both providers and clients."
Read more, and let me know what you think.
Venture capital
Venrock forecasts GLP-1 consensus, FTC inaction
Venture firm Venrock, which backs a dizzying array of health and tech startups including Lyra, Included Health and Aledade, canvassed almost three hundred experts from startups, investment firms, academic institutions and other groups to predict progress health tech issues — and many were especially cynical about the Federal Trade Commission, predicting little movement on issues like anti-trust investigations into the health care industry. (Still, the Justice Department's Antitrust Division announced late last week it had formed a new Task Force on Health Care Monopolies and Collusion.)
"The FTC/DOJ/Congress will continue to get less actually done in healthcare. It remains that policy making and regulatory enforcement are more of a political talking point than potent intervention. Doing the hard thing, for good, should be easier. (P.S. CMS has done a really nice job recently)," authors wrote in the report. More than a third of respondents thought the agency would try to hold United Healthcare accountable for anti-competitive behavior, but that the issue would get held up in courts and eventually dropped. (See chart below, from the report.)
Asked which health tech startups are most likely to get acquired next year, more than a quarter singled out Carbon; also in the mix were Omada, Komodo and Accolade as potential targets.
Venrock also acknowledged where last year's prognosis missed the mark — including predictions that "Fed rates would have dropped by now and only a quarter of us were optimistic that the stock market would end the year up. We were also way off on Ozempic, predicting disillusionment after early adoption."
on the hill
Health AI experts, companies ramp up DC presence
I'm noticing a growing number of health tech and AI fly-ins in D.C., especially from companies and research institutions who have previously eschewed lobbying and policy work. They seem increasingly anxious to shape any potential regulations to allow new ideas and companies to flourish, instead of what they perceive as heavy-handed rules designed to protect patients' privacy and guard against discrimination while also restricting innovation.
- Late last week I dropped by the Stanford Biodesign Policy Program's first policy event, where experts debated why Medicare has been at times slow to cover emerging tech and areas where health data interoperability could get a boost, among other topics. One key takeaway: The data supporting the use and coverage of emerging technology doesn't always account for seniors, pointed out CMS' coverage and analysis group's chief strategy officer, Steven Farmer. "Companies should want CMS to have data on these populations," he said. But resolving CMS coverage is only one hurdle for companies eager to get their technology in the hands of more seniors, said Mike Carusi, a general partner at Lightstone Ventures. There's a "very complex set of characters we have to interact with" to encourage wider adoption, including the American Medical Association and other professional societies. "If the math doesn't work, it becomes increasingly difficult to invest in some of these products."
- The Consumer Technology Association, which organizes gadget trade show CES and which has a growing health tech contingent, convened another Congressional Digital Health Caucus briefing late last week along with AdvaMed on remote patient monitoring. Its first briefing, on AI, was in February. "Our goal from the outset with this Caucus is to educate members, so we define 'success' as seeing more members on Capitol Hill understanding and asking questions about health-focused technology and the opportunities to improve care," CTA's Jim Fellinger told me.
- CTA and the American Telemedicine Association are also hosting a joint advocacy day today featuring panelists from Amazon and a handful of Congressional offices, including that of Sen. Brian Schatz (D-Hawaii).
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