Today's News and Commentary

COVID cases spike even as US hits 200M vaccine milestone: “The number of Americans fully vaccinated against COVID-19 reached 200 million Wednesday amid a dispiriting holiday-season spike in cases and hospitalizations that has hit even New England, one of the most highly inoculated corners of the country.
New cases in the U.S. climbed from an average of nearly 95,000 a day on Nov. 22 to almost 119,000 a day this week, and hospitalizations are up 25% from a month ago. The increases are due almost entirely to the delta variant, though the omicron mutation has been detected in about 20 states and is sure to spread even more.
Deaths are running close to 1,600 a day on average, back up to where they were in October. And the overall U.S. death toll less than two years into the crisis could hit another heartbreaking milestone, 800,000, in a matter of days.”

Omicron may require fourth vaccine dose sooner than expected, Pfizer says: “Albert Bourla, Pfizer’s chief executive, had projected that a fourth dose might be needed 12 months after a third shot. But he said on CNBC’s ‘Squawk Box’ that the timeline might need to be moved up. One of the company’s top scientists recently said a fourth shot — possibly one targeting omicron — is likely to be necessary.”

U.S. FDA authorizes use of AstraZeneca COVID-19 antibody cocktail: “The U.S. Food and Drug Administration on Wednesday authorized the use of AstraZeneca's antibody cocktail to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.”

Senate votes to nix Biden's vaccine mandate for businesses: “The Senate on Wednesday voted to nix President Biden’s vaccine mandate for larger businesses, handing Republicans a symbolic win.
Senators voted 52-48 on the resolution, which needed a simple majority to be approved. Democratic Sens. Jon Tester (Mont.) and Joe Manchin (W.Va.) voted with Republicans, giving it enough support to be sent to the House. 
The resolution faces an uphill path in the House, where Republicans aren’t able to use a similar fast-track process to force a vote over the objections of Democratic leadership. Instead, Republicans are hoping to get the simple majority needed to force a vote through a discharge petition, which will require support from a handful of House Democrats.”

FDA authorizes Pfizer-BioNTech coronavirus vaccine booster shots for 16- and 17-year-olds amid omicron threat: “Federal regulators Thursday authorized booster shots of Pfizer-BioNTech’s coronavirus vaccine for 16- and 17-year-olds, a step that could bolster protection against delta, the dominant variant in the United States, and the emerging omicron version.”

Health Experts Worry CDC’s Covid Vaccination Rates Appear Inflated: “CDC as of Dec. 5 has recorded more seniors at least partly vaccinated — 55.4 million — than there are people in that age group — 54.1 million, according to the latest census data from 2019. The CDC’s vaccination rate for residents 65 and older is also significantly higher than the 89% vaccination rate found in a poll conducted in November by KFF.”
Other discrepancies are also reported.

The Coronavirus Attacks Fat Tissue, Scientists Find: “From the start of the pandemic, the coronavirus seemed to target people carrying extra pounds. Patients who were overweight or obese were more likely to develop severe Covid-19 and more likely to die.
Though these patients often have health conditions like diabetes that compound their risk, scientists have become increasingly convinced that their vulnerability has something to do with obesity itself.
Now researchers have found that the coronavirus infects both fat cells and certain immune cells within body fat, prompting a damaging defensive response in the body.”

About hospitals and health systems

City of Hope to acquire Cancer Treatment Centers of America for a reported $390M: “Hospital system City of Hope is acquiring Cancer Treatment Centers of America to build a national, integrated cancer research and treatment system.
Financial details of the acquisition were not disclosed, but Reuters reported the deal was valued at $390 million.”

About health insurers

Bright Health banks $750M investment from Cigna Ventures, New Enterprise Associates: “Insurtech startup Bright Health has secured a $750 million capital investment that includes funding from Cigna Ventures.
Cigna's investment arm is a new backer for the company. Bright Health's largest shareholder, New Enterprise Associates, will also participate as a co-investor. The funds will be used to help Bright Health continue to grow and enhance its differentiated alignment model.”
In a related article: Why Cigna Keeps Partnering With Its Competitors: “These partnerships with smaller insurers and tech companies help Cigna bridge blindspots in its insurance products and add new customers to its health services division, allowing it to better compete and mimic the strategy of larger insurers like UnitedHealth Group, said Rick Kes, a healthcare industry senior analyst at RSM.”

How ACA Marketplace Premiums Are Changing by County in 2022: “Premiums for ACA Marketplace benchmark silver plans are decreasing on average across the U.S. in 2022 for the fourth consecutive year. However, premium changes vary widely by location and by metal level, with premiums increasing in several cases. As most enrollees receive significant premium subsidies on the ACA Marketplaces, the net premium amount an exchange enrollee pays out-of-pocket depends on their income and the difference in the cost between the benchmark plan (second-lowest silver plan) and the premium for the plan they choose.”
The article has a helpful interactive U.S. map that gives changes for plans by county.

About pharma

In the Years before the COVID-19 Pandemic, Nearly 13 Million Adults Delayed or Did Not Get Needed Prescription Drugs Because of Costs: From Urban Institute research:
”We find the following:
—Nearly 13 million adults delayed getting or did not get needed prescription drugs in the past year because of the cost, including 2.3 million elderly Medicare beneficiaries and 3.8 million nonelderly adults with private insurance, 1.1 million with Medicaid, and 4.1 million who were uninsured at any point during the year.
—About 1 in 10 adults who were uninsured all year (9.5 percent) or part of the year (11.6 percent) reported unmet prescription drug needs, compared with 4.9 percent of Medicare beneficiaries, 3.0 percent of privately insured adults, and 5.6 percent of nonelderly adults with Medicaid.
—For both Medicare beneficiaries and privately insured adults, unmet prescription drug needs were most common among women, people with low incomes, and people with multiple chronic health conditions. Nearly all Medicare beneficiaries and more than 8 in 10 privately insured adults with unmet needs have been diagnosed with a chronic condition such as high blood pressure, high cholesterol, stroke, diabetes, arthritis, and respiratory illnesses.
—More than one-quarter of adults with Medicare (25.4 percent) and 5.3 percent of privately insured adults spent more than 1 percent of their family incomes on their individual out-of- pocket prescription drug costs. More than 3 percent of Medicare beneficiaries—and nearly 7 percent of beneficiaries with unmet prescription drug needs—spent more than 10 percent of their family incomes on prescription drugs.”

A pilot trial to evaluate the feasibility, acceptability, and accuracy of a digital pill system to measure PrEP adherence in men who have sex with men [MSM] who use substances: “Digital pill systems (DPS) comprise a radiofrequency emitter integrated into a gelatin capsule containing PrEP, which transmits data to a wearable Reader following ingestion, thereby enabling direct, real-time adherencemeasurement. This study evaluated the feasibility, acceptability, and accuracy of a DPS to measure PrEP adherence…
DPS are a feasible, acceptable, and accurate method of measuring PrEP adherence in MSM with substance use. Future investigations should incorporate DPS into behavioral interventions targeting nonadherence.”
In a related article from the CDC: PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE UNITED STATES – 2021 UPDATE: “In anticipation of likely FDA approval of a PrEP indication for cabotegravir (CAB) in late 2021, we added a new section about prescribing PrEP with intramuscular injections of CAB every 2 months for sexually active men, women, and transgender persons with indications for PrEP use.”

$56K Alzheimer’s drug avoiding Biden’s cost curbs, for now: “The medication known as Aduhelm would be protected from Medicare price negotiations for more than a decade under the Democratic drug pricing compromise before Congress, part of Biden’s social agenda legislation. That’s because the bill doesn’t allow Medicare to negotiate over newly launched drugs, providing a window for drugmakers to recoup investments in research and development. Biologics such as Aduhelm get 13 years of protection.”

Drug Company Settles with N.Y. for $200 Million in Sprawling Opioid Case: “The settlement with Allergan, a company that has made opioids but whose most well-known product is Botox, is the latest agreement in a trial jointly argued by New York State and two counties that began in June.”

About healthcare IT

10 biggest patient data breaches in 2021: “In 2021, 578 healthcare organizations reported to HHS more than 41.45 million individuals being affected by data breaches.”

Interoperability and Patient Access for Medicare Advantage Organizations and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers: CMS is putting on hold enforcement of some interoperability requirements. “This notification is to inform the public that CMS is exercising its discretion in how it enforces the payer-to-payer data exchange provisions. As a matter of enforcement discretion, CMS does not expect to take action to enforce compliance with these specific provisions until we are able to address certain implementation challenges.”

About healthcare policy

Biden promised to reverse Trump's health policies. He's done that -- mostly.: A really good review of the headline’s topic. The major actions still needed are:

  • The rule that got the most pushback from Democrats: Trump’s expansion of short-term health plans, which typically don’t cover pre-existing conditions.

  • A regulation expanding so-called association health plans — which allows businesses to band together to buy health coverage — has been stalled in the courts. A federal judge still hasn’t ruled on the measure, despite hearing the case back in 2019, and the Biden administration told the court as recently as this week that the administration is still considering the matter.

  • The last regulation allows for employers to provide subsidies for their workers to buy health coverage on the individual market.”

About the public’s health

New Zealand’s plan to end smoking: A lifetime ban for youth: “New Zealand has been at the front of social and public health initiatives. This one is the latest: New Zealand’s government believes it has come up with a unique plan to end tobacco smoking — a lifetime ban for those aged 14 or younger.
Under a new law the government announced Thursday and plans to pass next year, the minimum age to buy cigarettes would keep rising year after year.
That means, in theory at least, 65 years after the law takes effect, shoppers could still buy cigarettes — but only if they could prove they were at least 80 years old.” 
Unfortunately, this plan would not be politically feasible here ( less than 0.01% of agricultural land in NZ is devoted to tobacco cultivation). Further, it would impinge on our Constitutional right to abuse our bodies at the public’s expense.