Labs Developing Medical Tests Will Now Face Some FDA Scrutiny
Historically, such tests escaped federal regulation because they were considered low risk. But after the Theranos debacle, and as lab-developed tests become more complex and test for important things like genetic conditions, the FDA will start regulating them more. About 12,000 labs are affected, and legal action challenging the change is expected.
Stat:
FDA Finalizes Plan To Regulate Some Lab-Developed Tests
The Food and Drug Administration will start actively regulating tests developed in laboratories, with some exemptions, the agency announced on Monday. The agency’s action, which is expected to face legal challenges in courts, comes after Congress failed to pass a law to regulate such tests. (Lawrence, 4/29)
On the federal effort to improve cybersecurity —
Stat:
Biden Cybersecurity Plan For Hospitals Entails Carrots First, Then Sticks
The Biden administration’s plan to improve cybersecurity at hospitals starts off with incentives, but eventually hospitals will face penalties for not adopting measures to protect patient data, HHS Deputy Secretary Andrea Palm said Monday. (Wilkerson, 4/29)
Bloomberg:
UnitedHealth Hack: Lawmakers Probe Change Healthcare Data Breach
When a cyberattack on Change Healthcare paralyzed much of the US health-care system, some lawmakers saw it as proof its parent company, UnitedHealth Group Inc., was too big. UnitedHealth Chief Executive Andrew Witty saw it differently. He has said that the company’s size kept the hack, which crippled a network that handled $2 trillion in health claims a year, from being more harmful. It was “important for the country that we own Change Healthcare,” Witty said earlier this month. (Tozzi, Griffin, and Robertson, 4/29)
The Washington Post:
UnitedHealth Grew Very Big. Now, Some Lawmakers Want To Chop It Down.
The firm ranks as the nation’s fifth-largest company by revenue, just behind Apple and ahead of tech giants Alphabet and Microsoft. (Diamond, Rowland and Gilbert, 4/30)
Modern Healthcare:
Change Healthcare Update: CMS, NCQA Delay Quality Reporting
The Centers for Medicare and Medicaid Services and National Committee for Quality Assurance are extending insurers’ deadlines to submit quality data by two weeks due to “extraordinary circumstances” caused by the cyberattack on Change Healthcare. Health plans will now have until June 28 to report their performance on Healthcare Effectiveness Data and Information Set measures to NCQA and the agency. (Devereaux, 4/29)
KFF Health News:
KFF Health News' 'An Arm And A Leg': The Hack
In this episode of “An Arm and a Leg,” host Dan Weissmann explores what the fallout from a cyberattack says about antitrust concerns in health care. (4/30)
The Supreme Court's October term will include a case on veterans' health benefits —
The Washington Post:
Supreme Court To Hear Cases On Veterans’ Benefits, Pet Food And Visas Next Term
In a case that could have significant implications for those who serve in the military, the Supreme Court will weigh a matter involving two veterans who argue they were improperly denied medical benefits for treatment of post-traumatic stress disorder related to their service. Joshua Bufkin, who served in the Air Force from 2005 to 2006, and Norman Thornton, who served in the Army on active duty from 1988 to 1991, say they should get care under a benefit-of-the-doubt rule that requires the Department of Veterans Affairs to provide access to treatment when it is a close call whether the applicant qualifies. Both cases had evidence for and against them receiving benefits. (Jouvenal, 4/29)
