Articles Posted in Insurance

aduhelm-300x250As the nomination of Dr. Robert Califf to head the federal Food and Drug Administration advances, he and the agency already are confronting a major regulatory crisis over Aduhelm, a prescription drug targeted for Alzheimer’s treatment and approved on the thinnest of evidence.

An FDA sister agency, the Centers for Medicare and Medicaid Services (CMS), has joined the Department of Veterans Affairs in sharply restricting Aduhelm’s use and coverage for payment.

Quickly after the FDA approved the drug made by Biogen and the maker priced it at $56,000 annually for patients, the VA said it would consider Aduhelm for use in one of the nation’s largest health systems only on a case-by-case basis.

fdanulogo-300x126Critics are slamming the federal Food and Drug Administration for dropping the ball in informing the U.S. officials who run the Medicare, Medicaid, and veterans’ health programs about crucial regulatory decisions, leading the federal government apparently to pay hundreds of millions of dollars for patients to get a defective heart device and potentially to pay billions of dollars for a prescription medication targeted at Alzheimer’s but with questionable evidence of its effectiveness.

FDA officials insist that they acted in patients’ best interests when they posted on an agency website, along with thousands of other public communications, a warning letter issued to the maker of the HeartWare Ventricular Assist Device, or HVAD. That missive told the device maker HeartWare — and later its acquiring company Medtronic — that the FDA found serious problems with the HVAD tied to patient injuries and deaths.

The FDA eventually would amass “thousands of reports of suspicious deaths and injuries and more than a dozen high-risk safety alerts from the manufacturer,” ProPublica, the Pulitzer Prize-winning investigative new site found. “One horrifying device failure after another” led HVAD’s maker to halt the manufacture of the supposed life-sustaining heart pump. The firm has agreed to a long-term plan to deal with the calamity of patients who now cannot have the defective device removed.

joy-300x268Here’s a bit of good news that may make patients jump for joy to start off 2022: Surprise medical bills mostly are supposed to end, effective Jan. 1.

Consumers still must watch out for potential big hits on their emergency transportation costs and they will need to ensure scheduled services with medical providers occur “in network.”

Just a reminder that Congress surprised its critics at the close of 2020 by passing in bipartisan fashion a ban of a practice that patients complained was one of the worst financial menaces in their medical care: surprise bills.

hospitalbedhospice-300x200Profit-raking private investors, aka hedge funders, have taken aim at operations intended to help the elderly, desperately ill, and grievously injured experience a dignified death. The rapacious takeover of the hospice industry nationwide ought to be setting off political and regulatory alarms in a rapidly graying nation.

As is typically the case when MBA-driven interests buy up different kinds of enterprises, they not only don’t exhibit much concern about the whys or wherefores of a business. They focus, instead, on how they can build volume, while cutting services, staff, and costs, the Huffington Post reported, describing what private equity firms have targeted for hospices. As the online news site found:

“Today, private equity firms are acquiring American hospices at an astonishing rate. From 2012 to 2019, the number of hospices owned by private equity companies tripled. The pace of acquisitions seems to have only gotten faster during the Covid-19 pandemic. Industry brokers who have never before put together a deal involving private equity say they now field calls from private equity buyers multiple times a week. Tempted by a wave of retiring baby boomers, the-sky’s-the-limit Medicare payments, the mom-and-pop nature of the industry and a lack of regulation that is pretty startling even by U.S. standards, private equity now accounts for three out of every five new hospice acquisitions.”

manchin-150x150Record numbers of poor, working poor, and middle-class Americans are signing up to receive federal help to get affordable insurance to safeguard their health and finances. But will congressional politicking cost them this invaluable coverage — just before the nation goes to the polls for midterm elections?

For months now, President Biden and the Democrats have labored to put together a multitrillion-dollar legislative package dealing with the nation’s health needs, climate change, and more. Because Capitol Hill is so riven — among Democrats, as well as between Republicans and Democrats — the ambitious aspirations of those in the party barely in power have needed to be wrapped into a sprawling measure that can sidestep the filibuster and survive a complex legislative maneuver and on to passage.

Let’s be clear that 50 Republicans in the Senate and hundreds of GOP House members have refused to act in any way like American lawmakers, declining at all to work on the package and to sticking to partisan position that Democrats will need by themselves to pass measures needed and popular with voters.

carolynmaloneypresser-300x184Regular folks have known it, chapter and verse, forever. They experience it every time they pay for their prescription drugs. But Democrats in the U.S. House report in a 269-page study that they have spent three years on, have concluded that Big Pharma runs a world-class cash-raising racket that would make street crooks blush.

Well, formally, the House Committee on Oversight and Reform majority has assailed U.S. “drug-pricing practices that are ‘unsustainable, unjustified and unfair,’” the Washington Post reported. As the newspaper also said:

“[C]ompanies studied by the committee raised prices of common brand-name drugs during the past five years by nearly four times the rate of inflation. The report seeks to debunk industry contentions that companies’ price strategy is needed to plow money back into researching and developing new medicines, finding that revenue is substantially greater than those investments.”

covidshots-241x300The steady, global spread of the Omicron variant and the huge uncertainty about what menace it may pose also may provide a powerful prod for anyone still fence-sitting to finally get those coronavirus vaccinations, including booster shots.

Experts are furiously researching and may not know for weeks or longer whether Omicron will be worse than the Delta variant, which rages still in parts of the country, overwhelming health systems in the cooling North, notably in New HampshireMichigan and Minnesota.

But the Biden Administration and governments around the world are racing to get ahead of vigorous responses to Omicron.

bidenbbb-300x199Leave it to lawmakers on Capitol Hill to wait until the year’s end to take up a major package pushed by congressional Democrats and the Biden Administration and that could potentially improve Americans’ health — big time.

The machinations by which the proponents hope to pass the “Build Back Better” program have, sadly and significantly, prevented too many people from knowing until this legislative endgame the exact content and effects of this initiative.

This occurred because Congress is so riven, including within the Democratic Party, that ambitious plans and money for them went in and out of the law like children in a hot house on a summer vacation. Media reports have zeroed in on the politics surrounding the measure and its possible financing — and less so on what it contains.

aduhelm-300x250Taxpayers and patients are suffering the rising negative consequences of the federal Food and Drug Administration’s dubious decision to overrule its own independent expert advisors and to approve on scant evidence Aduhelm. It is a prescription drug targeting Alzheimer’s disease, and concerns are rising about the medication’s safety and costs, not to mention whether it really works.

FDA advisors had argued against the drug, cautioning  that it carries significant potential side effects including swelling and bleeding in the brain. Those taking Aduhelm have been warned to undergo frequent, regular, and pricey brain scans as safeguards.

Still, experts have been startled by a much-discussed death of a 75-year-old Canadian woman, who was taking the drug as part of a clinical trial. She suffered seizures, was hospitalized, had brain scans, and was diagnosed with brain swelling shortly before she died.

kaiser21healthinsurancesurvey-300x204Most Americans get their health insurance through their jobs, and that coverage continues to increase in cost with the average annual premiums in 2021 exceeding $22,200 for families and $7,700 for individuals — a 4% rise from 2020.

The price increases affecting 155 million non-elderly people with employer-provided coverage, as detailed in the annual Kaiser Family Foundation surve, may seem modest, year over year, especially given that conventional wisdom saw all health care costs hit hard by the coronavirus pandemic.

But the foundation notes that overall health coverage costs, borne by employers and their workers, have not spiked due to the coronavirus, though they have risen relentlessly over a decade (see figure, above).

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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