Today's News and Commentary

Too Much Choice Is Hurting America: Learning from subprime, health care and electricity: Great article from Paul Krugman in The NY Times. Here is the crux of his argument:
”But the argument that more choice is always good rests on the assumption that people have more or less unlimited capacity to do due diligence on every aspect of their lives — and the real world isn’t like that. People have children to raise, jobs to do, lives to live and limited ability to process information.
And in the real world, too much choice can be a big problem.
The lesson of subprime mortgages, health insurance and now Texas electricity is that sometimes people offered too much choice will make bigger mistakes than they imagined possible. But that’s not all. Too much choice creates space for predators who exploit our all-too-human limitations.”

About Covid-19

Global COVID-19 infections up for first time in seven weeks, WHO says: The headline speaks for itself.

Virus Variant in Brazil Infected Many Who Had Already Recovered From Covid-19: “B.1.1.7, first identified in Britain, has demonstrated the power to spread far and fast. In South Africa, a mutant called B.1.351 can dodge human antibodies, blunting the effectiveness of some vaccines.
Scientists have also had their eye on a third concerning variant that arose in Brazil, called P.1. Research had been slower on P.1 since its discovery in late December, leaving scientists unsure of just how much to worry about it.”
The concern is that this mutation may make it easier for the virus to re-infect those who previously had the disease.

Attacked and Threatened: Health care targeted in conflict and COVID-19: An interactive map showing global sites where healthcare institutions and personnel have been attacked and threatened. (Non- secure site.)

CDC says J&J Covid vaccine is OK for people who have allergic reaction to Pfizer’s or Moderna’s: “A CDC scientist said Monday that people who have an allergic reaction to the first dose of either the Pfizer or Moderna vaccine could get the J&J vaccine instead at least 28 days later.
The CDC currently recommends that people who have a severe allergic reaction to either of the two-shot vaccines not get the second shot.”

Countries urge drug companies to share vaccine know-how: “Across Africa and Southeast Asia, governments and aid groups, as well as the World Health Organization, are calling on pharmaceutical companies to share their patent information more broadly to meet a yawning global shortfall in a pandemic that already has claimed over 2.5 million lives. Pharmaceutical companies that took taxpayer money from the U.S. or Europe to develop inoculations at unprecedented speed say they are negotiating contracts and exclusive licensing deals with producers on a case-by-case basis because they need to protect their intellectual property and ensure safety.
Critics say this piecemeal approach is too slow at a time of urgent need to stop the virus before it mutates into even deadlier forms. WHO called for vaccine manufacturers to share their know-how to ‘dramatically increase the global supply.’”

Biden to announce ‘historic partnership’: Merck will help make Johnson & Johnson coronavirus vaccine, officials say: “President Biden will announce Tuesday that pharmaceutical giant Merck will help make Johnson & Johnson’s single-shot coronavirus vaccine — an unusual pact between fierce competitors that could sharply boost the supply of the newly authorized vaccine, according to senior administration officials.”

Novavax targets May approval for COVID-19 vaccine in the U.S.: “Novavax is targeting a second-quarter FDA filing for emergency use of its COVID-19 vaccine. The goal suggests the U.S. could join the U.K. on the list of countries to authorize the vaccine in the first half of the year.
The success of the vaccine in a 15,000-subject U.K. phase 3 clinical trial gives Novavax a clear path to a positive decision by the Medicines and Healthcare products Regulatory Agency (MHRA). However, the lack of data from another phase 3 trial that only recently completed enrolling 30,000 subjects in the U.S. and Mexico makes the route to a FDA OK less clear.”

7 signs those new N95s at your physician practice might be fake: “According to NIOSH [National Institute for Occupational Safety and Health] here are seven signs of counterfeit respirators that physicians and staffers at medical groups and health systems should look for:

  • No markings at all on the filtering facepiece respirator.

  • No approval number on filtering facepiece respirator or headband.

  • No NIOSH markings.

  • NIOSH spelled incorrectly.

  • Presence of decorative fabric or other decorative add-ons.

  • Claims of approval for children—NIOSH does not approve any type of respiratory protection for children.

  • Filtering facepiece respirator has ear loops instead of headbands”

A Covid Vaccine Side Effect, Enlarged Lymph Nodes, Can Be Mistaken for Cancer: “Coronavirus vaccinations can cause enlarged lymph nodes in the armpit or near the collarbone, which may be mistaken for a sign of cancer.
As vaccines are rolled out across the country, doctors are seeing more and more of these swollen nodes in recently immunized people, and medical journals have begun publishing reports aimed at allaying fears and helping patients avoid needless testing for a harmless condition that will go away in a few weeks.”

J&J COVID-19 vaccine shipping to U.S., but new deliveries hinge on regulators: “Johnson & Johnson will ship nearly 4 million doses of its newly authorized single-dose COVID-19 vaccine around the United States this week, but a top executive said on Monday that the next round of deliveries is contingent on regulatory approvals at a new plant.”

The Trump administration quietly spent billions in hospital funds on Operation Warp Speed: “The Trump administration quietly took around $10 billion from a fund meant to help hospitals and health care providers affected by Covid-19 and used the money to bankroll Operation Warp Speed contracts, four former Trump administration officials told STAT.
The Department of Health and Human Services appears to have used a financial maneuver that allowed officials to spend the money without telling Congress, and the agency got permission from its top lawyer to do so. Now, the Biden administration is refusing to say whether the outlay means there will be less money available for hospitals, physicians, nursing homes, and other providers.”

New Orleans archdiocese urges Catholics to avoid new Johnson & Johnson vaccine: “The archdiocese issued the statement on Friday (Feb. 26), stating that while the decision regarding whether to get a vaccine is an individual choice, ‘the latest vaccine from Janssen/Johnson & Johnson is morally compromised as it uses the abortion-derived cell line in development and production of the vaccine as well as the testing.’
Several COVID-19 vaccine manufacturers used cells originally derived from tissue from an aborted fetus in the 1970s, but the Moderna and Pfizer-BioNTech vaccines used the cell lines only to test their vaccines, making the ‘connection to abortion … extremely remote,’ the statement said.”

Updates on Covid-19 test approvals:
Eurofins Receives FDA Emergency Authorization for Over-the-Counter COVID-19 Test: “The at-home COVID-19 nasal polymerase chain reaction (PCR) kit can be sold directly to consumers without a prescription and can be ordered online for $99, the company said.”
Quidel’s At-Home COVID-19 Test Gets FDA EUA: “Patients using the antigen test can collect their own samples at home and do not need to send them off to a laboratory for analysis. The device is authorized for prescription home use with self-collected anterior nasal swabs from patients aged 14 and older or individuals 8 and up whose swabs are collected by an adult.”

Vaccine Significantly Lessened Asymptomatic Infections: “A single dose of the Pfizer/BioNTech vaccine significantly lowers asymptomatic SARS-CoV-2 infections, which means it also reduces the risk of transmission from asymptomatic individuals, a new UK study has shown.
Researchers at Cambridge University analyzed thousands of COVID-19 tests from staff working in a UK hospital in January and found that healthcare workers were four times less likely to become infected with COVID-19 12 days postvaccination with a single shot — and asymptomatic infections dropped by 75 percent.”

About health insurance

Highmark, HealthNow New York complete affiliation: “Highmark has completed its affiliation with HealthNow New York, bringing its membership to more than 6 million and making it the country's fourth-largest Blues plan.
Under the deal, HealthNow will be rebranded as Highmark Blue Cross Blue Shield of Western New York and Highmark Blue Cross Blue Shield of Northeastern New York. The New York insurer will maintain local leadership and offices to continue as a community presence…”

CMS pushes pause on controversial Geographic Direct Contracting model: “The Biden administration is reviewing a controversial payment model that would tie Medicare payments to spending and quality for an entire region.
The Centers for Medicare & Medicaid Services’ (CMS') webpage for the Geographic Direct Contracting model said it is currently under review in an update posted Monday.
The agency did not immediately respond to a request for comment on the reason the model was put under review nor for how long it would happen.”

Biden Administration’s Plan to Rescind States’ Medicaid Work Rules Faces Temporary Hitch: “Just weeks before President Biden took office, the Trump administration urged states in a Jan. 4 letter to sign agreements that would preserve work requirements in the program for nine months before they could be undone by the federal government. 
The letters say the Centers for Medicare and Medicaid Services, the federal agency that oversees the program, must go beyond offering states a hearing to contest changes, as is typically the case, and instead follow a longer, nine-month process for revoking the arrangements. An HHS spokesman said 17 states signed the agreements, including Georgia, Tennessee and Arkansas. 
Republican leaders in the states, having signed those agreements, say work requirements should be binding until September.”

Limiting Private Insurance Reimbursement to Medicare Rates Would Reduce Health Spending by About $350 Billion in 2021: Among findings from this Kaiser family Foundation study:

  • Total health care spending for the privately insured population would be an estimated $352 billion lower in 2021 if employers and other insurers reimbursed health care providers at Medicare rates. This represents a 41% decrease from the $859 billion that is projected to be spent in 2021.

  • Aggregate employer contributions toward employee premiums would decrease by about $194 billion, assuming employers’ share of premiums stays constant after private rates drop to Medicare levels.

  • Employees and their dependents would spend at least $116 billion less for health care, through a combination of lower premiums and out-of-pocket spending. The reduction in federal and individual spending on health care for an estimated 19 million people in the non-group market would total $42 billion.

  • Nearly half of the total reduction in spending (45%) would be for outpatient hospital services, due in part to high private rates relative to Medicare rates for outpatient care, compared to most other services. Inpatient services account for 27% of the decrease in spending, and physician office visits account for 14% of the decrease.

  • Health care spending for privately insured adults ages 55 to 64 would be an estimated $115 billion lower in 2021 if private insurers used Medicare rates—this is one third of the estimated total reduction in spending. The proportion of the decrease in spending attributable to adults 55 to 64 is roughly equivalent to their share of current spending.”

Hospitals rely on cost shifting to private insurers to make up for lower Medicare and Medicaid payments, free care and underpaid services. Where can they make up this difference? Also, private insurers would need to change from fee-for-service or per diems to DRGs to get comparable inpatient rates.

An Employer-Provider Direct Payment Program Is Associated With Lower Episode Costs: “We examined the impacts on episode cost and patient cost sharing of a program that applies bundled payments for orthopedic and surgical procedures in a commercially insured population. The program we studied negotiates preferred prices for selected providers that cover the procedure and all related care within a thirty-day period after the procedure and waives cost sharing for patients who receive care from these providers. After implementation, episode prices for three selected surgical procedures declined by $4,229, a 10.7 percent relative reduction. Employers captured approximately 85 percent of the savings, or $3,582 per episode (a 9.5 percent relative decrease), and patient cost-sharing payments decreased by $498 per episode (a 27.7 percent relative decrease).”

About pharma

AstraZeneca’s and Amgen’s Tezepelumab Slashes Severe Asthma Attacks: “AstraZeneca’s and Amgen’s biologic drug tezepelumab reduced the rate of asthma attacks by 56 percent among patients with severe and uncontrolled forms of the condition, according to their phase 3 trial results.
Tezepelumab works by blocking the action of thymic stromal lymphopoietin (TSLP), an immune protein in the lining of the lungs that plays a key role in asthma inflammation, as well as helping to alert the body’s immune system that it needs to react to a threat…
Tezepelumab improved lung function in patients, helped control asthma better and cut the risk of hospitalizations or emergency visits by 79 percent, trial data showed.”
Since the mechanism of action is new, this drug could be a real innovation in asthma treatment.

Takeda Sells Off Four Diabetes Drugs in $1.25 Billion Deal: “Takeda is divesting itself of the rights to Nesina, Liovel, Inisync, and Zafatek, transferring the assets, marketing rights and eventually marketing authorization associated with the portfolio to Teijin. The four drugs generated about $290 million in sales for Takeda in fiscal year 2019.”

Perrigo Announces Agreement To Sell Generic Rx Business For $1.55 Billion In Total Consideration: “Perrigo Company plc, a leading global provider of Consumer Self-Care Products, announced today that it has reached a definitive agreement to sell its Generic Rx Pharmaceuticals business to Altaris Capital Partners, LLC for total consideration of $1.55 billion, including $1.5 billion in cash, subject to customary adjustments. As part of the consideration, Altaris will also assume more than $50 millionin potential R&D milestone payments and contingent purchase obligations with third-party Rx partners.”

Spending For Orphan Indications Among Top-Selling Orphan Drugs Approved To Treat Common Diseases: “The Orphan Drug Act of 1983 provides benefits to promote the development of treatments for rare diseases that have limited sales potential. Policy makers have questioned whether this purpose is furthered in the case of “partial orphan drugs” approved to treat both rare and common diseases, as many of these drugs are top sellers. In this study we used national commercial claims data to estimate the proportion of spending in the US on fifteen top-selling partial orphan drugs that was assigned to orphan indications in 2018. Of this spending, 21.4 percent was assigned to orphan indications, 70.7 percent to nonorphan indications, and 7.9 percent to neither orphan nor nonorphan indications (for example, off-label use). These findings support growing concerns regarding the costs of granting orphan drug benefits to the sponsors of top-selling partial orphan drugs.”
This article is a great start for discussions centering on re-evaluating the orphan drug subsidies.

About healthcare IT

Principal Deputy Inspector General Grimm on Telehealth: Among the messages in this announcement: “We are aware of concerns raised regarding enforcement actions related to ‘telefraud’ schemes, and it is important to distinguish those schemes from telehealth fraud. In the last few years, OIG has conducted several large investigations of fraud schemes that inappropriately leveraged the reach of telemarketing schemes in combination with unscrupulous doctors conducting sham remote visits to increase the size and scale of the perpetrator's criminal operations. In many cases, the criminals did not bill for the sham telehealth visit. Instead, the perpetrators billed fraudulently for other items or services, like durable medical equipment or genetic tests. We will continue to vigilantly pursue these ‘telefraud’ schemes and monitor the evolution of scams that may relate to telehealth.”

USDA invests $42M in telehealth infrastructure: “In a move to help rural residents gain access to healthcare and educational opportunities, the United States Department of Agriculture is investing $42.3 million in telemedicine and distance learning infrastructure.
Rural areas have greater infection and death rates from COVID-19 because of several factors, including a much higher percentage of underlying conditions, difficulty accessing medical care and lack of health insurance.
The $42.3 million in awards includes $24 million provided through the CARES Act. The investments will benefit five million rural residents in total.”

About hospitals and health systems

Three articles on financial performance:
How CHS, HCA, Tenet and UHS fared in Q4
UPMC annual operating revenue hits $23B: 5 notes
The Challenging Future of the Chicago Safety Net: “The most important safety net hospitals on the city's west and south sides are projected to reach a compounded operaAng loss of $1.76 billion in the coming years.
Based on historical financial trends and our longitudinal modeling, the seven primary safety net hospitals on Chicago’s south side (Advocate Trinity1, Roseland Community, St. Bernard, Holy Cross, Mercy, Jackson Park, and South Shore) are projected to endure a total loss of $1.34 billion by 2024.
The safety net hospital cohort to the city’s west (consisAng of Mount Sinai, LoreZo, St. Anthony, AMITA Health Saint Mary, Elizabeth Medical Center - Saint Mary Campus2, and Norwegian) will bear $421 million in compounded operaAng losses over the same period.”
Start to read about possible solutions to the problem on page 37.

About healthcare personnel

High Nursing Staff Turnover In Nursing Homes Offers Important Quality Information: “Mean and median annual turnover rates for total nursing staff were roughly 128 percent and 94 percent, respectively. Turnover rates were correlated with facility location, for-profit status, chain ownership, Medicaid patient census, and star ratings. Disseminating facilities’ nursing staff turnover rates on Nursing Home Compare could provide important quality information for policy makers, payers, and consumers, and it may incentivize efforts to reduce turnover.”