About Covid-19
Fauci says the U.S. will meet Biden's July 4 vaccination goal: “Around 160 million Americans have received at least one shot. Around half a million people need to receive their first shot over the next 44 days in order for Biden to meet his goal.”
U.S. reports fewer than 30,000 cases for five straight days, with the nation averaging 1.8 million daily vaccinations: “The U.S. has reported fewer than 30,000 cases for five straight days, bringing the seven-day average of daily new infections to about 30,300.
Roughly 1.8 million vaccinations have been reported on average each day over the past week, and 48% of the population has received at least one dose.”
FDA allowing longer refrigerator storage for Pfizer-BioNTech vaccines: “The agency moved to extend the storage time for thawed shots to up to one month between 35 and 46 degrees Fahrenheit, instead of the previous regulation of up to five days.”
CytoDyn shares plummet after FDA blasts the biotech for cherry-picking COVID-19 data: This case highlights the reason we need independent reviews:
“Back in March, a phase 3 clinical trial of CytoDyn’s leronlimab failed on the primary goal of reducing symptoms and all secondary goals, including one that questioned whether the therapy could reduce mortality. But the company instead focused its data release on a subgroup of 62 mechanically ventilated, critically ill COVID-19 patients, claiming that the drug spurred a 24% reduction in all-cause mortality and a six-day reduction in hospitalization, among other trial wins.
CytoDyn then issued a second press release after performing an ‘age adjustment’ analysis that claimed to show leronlimab reduced mortality in older patients.
Now, the FDA has broken its usual vow of silence on disclosing information on unapproved products to say that CytoDyn’s reshaping of the data is erroneous.”
About health insurance
Startup insurer Bright Health files to go public: “In its filing, Bright Health boasted $1.2 billion in revenue for 2020 and approximately 623,000 members in its commercial and Medicare Advantage plans. The insurer operates in 99 markets across 14 states.”
Single moms sue Missouri for refusing to expand Medicaid: ”Two single mothers are among a group of low-income adults who on Thursday sued Missouri Gov. Mike Parson’s administration for dropping plans to expand Medicaid.
The two moms and a third woman asked a Cole County judge to force the state to give them coverage under the government health care program, as called for in a constitutional amendment approved by voters last year.”
To my knowledge, this law suit is unprecedented.
Kansas governor vetoes bill on short-term health insurance: ”Democratic Gov. Laura Kelly on Wednesday vetoed a bill favored by many Republican lawmakers that could have encouraged some people to stick longer with short-term health coverage that critics label ‘junk insurance.’
The bill’s backers said it simply would have given people who buy limited duration health insurance more protection against premium increases or coverage changes. Such plans, lasting up to a year, offer lower premiums than comprehensive plans but don’t cover pre-existing medical conditions and other items such as medications or maternity care.”
Cardiologist sentenced for decade-long healthcare scheme: “Asim Hameedi, MD, previously pleaded guilty to conspiracy to commit healthcare fraud. Dr. Hameedi was president and owner of a clinic in New York City called City Medical Associates.
According to the indictment, court filings and proceedings, Dr. Hameedi worked with co-conspirators to falsify patients' symptoms to get prior authorizations for medical tests and procedures. He also backdated bills to get around prior authorization requirements, submitted false claims to insurers and violated HIPAA by viewing patients' EHRs without authorization, among other actions, according to the Department of Justice.”
Why did it take so long to uncover this fraud? What would have happened if payments were global or capitated?
UnitedHealthcare introduces new initiative to improve health equity: “The payer is working with the Council of Large Public Housing Authorities, public housing agencies, federally qualified health centers and community-based organizations in a "mutual commitment" to close gaps in care, according to a May 19 news release.
The group will analyze claims, healthcare utilization and local data to address issues regarding food insecurity, health literacy, maternal and women's health, mental health, homelessness, healthcare access, and chronic disease management.”
About healthcare IT
CaptureRx data breach compromised 1.6M individuals' data: 13 hospitals, healthcare providers affected: “CaptureRx helps hospitals manage their 340B drug programs and said it discovered unusual activity in some of its files back in February. Compromised files contained patient records with protected health information, including names, birthdates and prescription details.
CaptureRX reported that there are 1,656,569 known victims affected by the breach.”
GAO tells Congress to halt expanding telehealth until there's more research: “The Government Accountability Office testified in front of Congress that government agencies should wait until after the pandemic, when there is more research, before expanding telehealth coverage for Medicare and Medicaid programs, according to a May 19 report.
Telehealth capabilities were vital during the start of the pandemic, but now it's deemed safe to return to a physician's office. Some officials from GAO are concerned that there have not been enough studies proving that virtual visits are just as effective as in-person visits.
In addition, telehealth visits can increase CMS' spending if virtual visits are reimbursed the same as in-person visits. There is also an increased risk of fraud, waste and abuse that GAO has previously noted because some program safeguards have been suspended.”
About pharma
NICE Rejects J&J’s Oral Prostate Cancer Drug Over Costs: A reminder that other countries make cost/benefit decisions on drug coverage: “The cost-appraising body said the drug’s price, approximately $ 3,879 per pack of 112 tablets, was too expensive and that patients had other oral prostate cancer treatment options, including Bayer’s Nubeqa (darolutamide).”
Bill Ending Orphan Drug Exclusivity Loophole Clears House: A bit more clarification on this Bill (passed two days ago): “H.R. 1629, the Fairness in Orphan Drug Exclusivity Act, which amends existing legislation to require drugmakers who receive seven years of market exclusivity for a drug that treats a nonrare disease to provide regular updates to the FDA explaining why they can’t reasonably expect to recoup research and development costs from sales within 12 years of launch.
If companies are unable to provide adequate justification to the agency, H.R. 1629 gives the FDA the power to revoke orphan drug exclusivity for the nonrare disease drugs.”
Magellan Rx Management’s Medical Pharmacy Trend Report Unlocks the Latest Trends and Emerging Strategies to Manage Rising Medical Benefit Specialty Drug Spend: This annual report has some very specific details about drugs as well as overall trends. A major finding that exemplifies the basis for increased costs is: “The oncology pipeline had more than 700 drugs in clinical trials in 2019 and is forecasted to increase 105% in PMPM spend from $52 in 2019 to $106 in 2024.”
About hospitals and healthcare systems
Colorado Will Pay Hospitals to Close Expensive Free-Standing ERs: “Colorado health officials so abhor the high costs associated with free-standing emergency rooms they’re offering to pay hospitals to shut the facilities down.
The state wants hospitals to convert them to other purposes, such as providing primary care or mental health services.
At least 500 free-standing ERs have set up in more than 20 states in the past decade. Colorado has 44, 34 owned by hospitals.
The trend began a decade ago with hopes these stand-alone facilities would fill a need for ER care when no hospital was nearby and reduce congestion at hospital ERs.
But that rarely happened.”
HCA to fund $50M in community projects: “The "Healthier Tomorrow Fund" will support grants to nonprofit organizations that run health and workforce projects. Up to $5 million will be distributed in the fund's first year to support high-priority community needs and health equity efforts.
The 25 communities include cities in Texas, Florida, Missouri, Colorado and North Carolina. HCA plans to eventually expand the fund to additional communities.”
About healthcare technology
FDA drafts guidance on cutting-edge devices for controlling Type 2 diabetes: “A new draft guidance (PDF) from the agency is aimed at hardware designed to directly improve HbA1c levels in people with Type 2 diabetes mellitus, regardless of whether or not they are taking insulin or another drug regimen—an area where no devices have yet been approved.
The FDA’s new recommendations for study design do not apply to software programs and devices used to monitor blood sugar, calculate doses and deliver insulin, such as continuous glucose monitors or digitally connected pens and pumps…
For interventions involving higher-risk surgical or endoscopic procedures or implants, the agency urged a follow-up period of at least one year and recommended that companies limit their use to patients whose diabetes has not come under control despite the use of at least two non-insulin medications, including one at its maximum dose.”
FDA finalizes ‘leapfrog’ guidance on use of thought-controlled tech in paralysis patients, amputees: ”The agency issued the final version of its guidanceon brain-computer interface technology, outlining best practices for clinical and nonclinical testing of implanted devices that use brain activity to restore motor and sensory capabilities in patients with paralysis or amputation…
The draft guidance offered recommendations about these devices’ electrical and electromagnetic safety needs, plus their long-term biocompatibility with users’ blood, cerebrospinal fluid and nerve tissue. It also advised technology developers on using nonclinical testing to mitigate any potential risks before beginning carefully designed clinical studies.”
The top 10 medtech VC rounds of 2020: FYI
ASCO Abstracts: The American Society of Clinical Oncology meets June 4-8, but the abstracts have been released and are available at this web address.