FDA gives Quest EUA for their at-home sample collection kit for COVID-19 testing; Plans to produce 500k units by end of June
Trump Administration bungled distribution of initial remdesivir doses; Gave doses to hospitals that were lacking ICUs, patients, or the ability to store it properly
Experts say Medicare's new $35 copay cap for insulin is hardly a win as it applies only to insulin, doesn't change actual prices, and will drive premiums up, all while giving drug companies political cover
Relaxed regulations and improved payments lead to Medicare telehealth visits exploding from 11,000 per week in March to 1.3M in a week in April
FDA says it abruptly shut down Gates-backed Seattle coronavirus study for lacking EUA, institutional review board ethics approvals
CDC now saying antibody tests shouldn't be used for determining individual immunity; In certain scenarios 'less than half of those testing positive will truly have antibodies'
CMS announces 1,750 insurance plans have agreed to cap insulin costs for Medicare Advantage and Part D members at $35/month; Drugmakers have also agreed to the plan
Philips gets FDA 510(K) clearance for Biosensor BX100; Disposable chest patch that lets providers remotely monitor patient heart and respiratory rates
CMS expands Medicare Advantage telehealth rules to allow plans to include more specialists to meet network adequacy standards; Also allows ESRD patients to enroll in MA plans
HHS begins distributing CARES grants to skilled nursing facilities; Each SNF will receive $50K plus $2.5K per bed
Stericycle predicts a surge in medical device recalls starting in Q3 as FDA Emergency Use Authorizations and enforcement-discretion end
FCC has approved telehealth infrastructure grants amounting to $33M across 89 providers, but has only actually distributed funds to one provider
Analysis: How medical supply chains work, and how federal response to supply chain troubles in times of pandemic can be improved
CMS says nursing homes should stay closed to visitors until they have no new COVID-19 cases for 28 days and should test workers weekly
Study shows more ACOs are led by physician groups than hospitals, with new growth driven by physician groups; Argues future regulation and model development should focus on physician needs
White House pushing Congress to require hospitals and insurers to disclose negotiated prices in future COVID-19 relief bills
FDA abruptly orders Seattle Coronavirus Assessment Network, a Gates-backed initiative to do broad coronavirus testing, to stop performing tests and reporting results pending review
Trump administration to rework Strategic National Stockpile of drugs and medical supplies; Increasing supplies to 90 days, smoothing communication between agencies, more closely monitoring shelf-life
Analysis: By distributing CARES Act relief funds according to patient revenue, HHS gave more than 2x the relief funds on a per-bed basis to hospitals that earn more revenue from private insurers
Trump administration to name Moncef Slaoui, former GSK vaccine head, to be 'therapeutics czar'; Will lead government efforts to speed COVID-19 vaccine development
IRS gives employers ability to allow employees to change health benefits elections outside enrollment periods; Includes dropping coverage, adding family members, switching plans
Analysis: As of May 2, 27 million have lost employer sponsored insurance; 79% of those are eligible for subsidized coverage through Medicaid or subsidized exchange plans
Doctor on Demand to start offering services to Medicare Part B FFS beneficiaries; Assuming telehealth regulations will remain loosened post-pandemic
CMS circulates draft guidelines for reopening nursing homes; Industry says they're too vague, while experts say it's too soon to reopen
HHS outlines plan for remdesivir distribution: drug supply will be given over to states, whose health departments will distribute to hospitals based on determinations of need
KHN investigation shows many hospitals receiving HHS relief funds have been recently fined, including one that received $67M in bailouts and owes a $40M penalty June 1 due to a recent antitrust judgement
At least three recently bankrupt hospitals have sued for access to the SBA Paycheck Protection Program to pay their staffs and keep doors open
CMS issues new rules for insurance exchanges including tweaks to special enrollment periods, redeterminations of eligibility for financial help, and how prescription drug rebates count towards OOP maximums and MLR totals
FDA pulls approval for 60+ mask makers in China after discovering products don't meet safety standards
FDA grants EUA for Sherlock Biosciences' CRISPR-based coronavirus test; First CRISPR product through the FDA
FDA reverses course, will now require coronavirus antibody tests to receive emergency use authorization; Only 12 tests have been authorized so far, 250+ are pending
Analysis: AI tools and technologies will challenge established regulatory frameworks, as well as the authority of physicians
CMS issues interim rule to remove spending associated with COVID patients from performance calculations for ACOs
Health insurers are telling investors they're largely untroubled by the pandemic, while their lobbying group, AHIP, is asking Congress for relief funds
CMS announces new rules to extend telehealth coverage & boost payment rates; Also relaxing rules to make it easier to get coronavirus testing
Analysis: The "innovation premium" Americans pay in the form of higher prescription drug prices doesn't provide clear benefits, should be studied more deeply
Analysis: Government and private insurers must act to alleviate unprecedented & systemic financial pressures facing independent practices
Pear Therapeutics launches digital therapeutic for schizophrenia during FDA emergency period; Therapy is combination of digital interventions, medication, and physician supervision
Analysis: How the Amish health care system produces comparable results to the American system at a fraction of the cost
National Institutes of Health facilitating challenge for innovators to win funding for rapid coronavirus testing technologies; winners will receive funding from NIH and commercialization support from industry experts
Analysis of the Supreme Court's ruling on risk corridors and what happens now: the effect on MLRs, who will receive funds, and other impacts of the decision
California fines more than a dozen drug makers for not providing drug pricing data; Fines reached a total of $17.5M, mostly in 2020
CVS will offer coronavirus testing at 1,000 locations; More retailers expected to follow suit after Trump administration meeting
Supreme Court rules commercial health insurers are owed $12B in payments from government; Ruling settles legal uncertainty around the ACA's risk corridor program
