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Covid-19 infections from variant strains are quickly spreading across the U.S., but there’s one big problem: Lab officials say they can’t tell patients or their doctors whether someone has been infected by a variant.

Federal rules around who can be told about the variant cases are so confusing that public health officials may merely know the county where a case has emerged but can’t do the kind of investigation and deliver the notifications needed to slow the spread, according to Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

“It could be associated with a person in a high-risk congregate setting or it might not be, but without patient information, we don’t know what we don’t know,” Hamilton said. The group has asked federal officials to waive the rules. “Time is ticking.”

The problem is that the tests in question for detecting variants have not been approved as a diagnostic tool either by the Food and Drug Administration or under federal rules governing university labs ― meaning that the testing being used right now for genomic sequencing is being done as high-level lab research with no communication back to patients and their doctors.

Amid limited testing to identify different strains, more than 1,900 cases of three key variants have been detected in 46 states, according to the Centers for Disease Control and Prevention. That’s worrisome because of early reports that some may spread faster, prove deadlier or potentially thwart existing treatments and vaccines.

Officials representing public health labs and epidemiologists have warned the federal government that limiting information about the variants ― in accordance with arcane regulations governing clinical labs ― could hamper efforts to investigate pressing questions about the variants.

The Association of Public Health Laboratories and the Council of State and Territorial Epidemiologists earlier this month jointly pressed federal officials to “urgently” relax certain rules that apply to clinical labs.

Washington state officials detected the first case of the variant discovered in South Africa this week, but the infected person didn’t provide a good phone number and could not be contacted about the positive result. Even if health officials do track down the patient, “legally we can’t” tell him or her about the variant because the test is not yet federally approved, Teresa McCallion, a spokesperson for the state department of health, said in an email.

“However, we are actively looking into what we can do,” she said.

Lab testing experts describe the situation as a Catch-22: Scientists need enough case data to make sure their genome-sequencing tests, which are used to detect variants, are accurate. But while they wait for results to come in and undergo thorough reviews, variant cases are surging. The lag reminds some of the situation a year ago. Amid regulatory missteps, approval for a covid-19 diagnostic test was delayed while the virus spread undetected.

The limitations also put lab professionals and epidemiologists in a bind as public health officials attempt to trace contacts of those infected with more contagious strains, said Scott Becker, CEO of the Association of Public Health Laboratories. “You want to be able to tell [patients] a variant was detected,” he said.

Complying with the lab rules “is not feasible in the timeline that a rapidly evolving virus and responsive public health system requires,” the organizations wrote.

Hamilton also said telling patients they have a novel strain could be another tool to encourage cooperation ― which is waning ― with efforts to trace and sample their contacts. She said notifications might also further encourage patients to take the advice to remain isolated seriously.

“Can our investigations be better if we can disclose that information to the patient?” she said. “I think the answer is yes.”

Public health experts have predicted that the B117 variant, first found in the United Kingdom, could be the predominant variant strain of the coronavirus in the U.S. by March.

As of Tuesday, the CDC had identified nearly 1,900 cases of the B117 variant in 45 states; 46 cases of B1351, which was first identified in South Africa, in 14 states; and five cases of the P.1 variant initially detected in Brazil in four states, Dr. Rochelle Walensky, the CDC director, told reporters Wednesday.

A Feb. 12 memo from North Carolina public health officials to clinicians stated that because genome sequencing at the CDC is done for surveillance purposes and is not an approved test under the Clinical Laboratory Improvement Amendments program ― which is overseen by the U.S. Centers for Medicare & Medicaid Services ― “results from sequencing will not be communicated back to the provider.”

Earlier this week, the topic came up in Illinois as well. Notifying patients that they are positive for a covid variant is “not allowed currently” because the test is not CLIA-approved, said Judy Kauerauf, section chief of the Illinois Department of Public Health communicable disease program, according to a record obtained by the Documenting COVID-19 project of Columbia University’s Brown Institute for Media Innovation.

The CDC has scaled up its genomic sequencing in recent weeks, with Walensky saying the agency was conducting it on only 400 samples weekly when she began as director compared with more than 9,000 samples the week of Feb. 20.

The Biden administration has committed nearly $200 million to expand the federal government’s genomic sequencing capacity in hopes it will be able to test 25,000 samples per week.

“We’ll identify covid variants sooner and better target our efforts to stop the spread. We’re quickly infusing targeted resources here because the time is critical when it comes to these fast-moving variants,” Carole Johnson, testing coordinator for President Joe Biden’s covid-19 response team, said on a call with reporters this month.

Hospitals get high-level information about whether a sample submitted for sequencing tested positive for a variant, said Dr. Nick Gilpin, director of infection prevention at Beaumont Health in Michigan, where 210 cases of the B117 variant have been detected. Yet patients and their doctors will remain in the dark about who exactly was infected.

“It’s relevant from a systems-based perspective,” Gilpin said. “If we have a bunch of B117 in my backyard, that’s going to make me think a little differently about how we do business.”

It’s the same in Washington state, McCallion said. Health officials may share general numbers, such as 14 out of 16 outbreak specimens at a facility were identified as B117 ― but not who those 14 patients were.

There are arguments for and against notifying patients. On one hand, being infected with a variant won’t affect patient care, public health officials and clinicians say. And individuals who test positive would still be advised to take the same precautions of isolation, mask-wearing and hand-washing regardless of which strain they carried.

“There wouldn’t be any difference in medical treatment whether they have the variant,” said Mark Pandori, director of the Nevada State Public Health Laboratory. However, he added that “in a public health emergency it’s really important for doctors to know this information.”

Pandori estimated there may be only 10 or 20 labs in the U.S. capable of validating their laboratory-based variant tests. One of them doing so is the lab at the University of Washington in Seattle.

Dr. Alex Greninger, assistant director of the clinical virology laboratories there, who co-created one of the first tests to detect SARS-CoV-2, said his lab began work to validate the sequencing tests last fall.

Within the next few weeks, he said, he anticipates having a federally authorized test for whole-genome sequencing of covid. “So all the issues you note on notifying patients and using [the] results will not be a problem,” he said in an email.

Companies including San Diego-based Illumina have approved covid-testing machines that can also detect a variant. However, since the add-on sequencing capability wasn’t specifically approved by the FDA, the results can be shared with public health officials ― but not patients and their doctors, said Dr. Phil Febbo, Illumina’s chief medical officer.

He said they haven’t asked the FDA for further approval but could if variants start to pose greater concern, like escaping vaccine protection.

“I think right now there’s no need for individuals to know their strains,” he said.

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"Concerns voiced by experts late in 2020 about a “twindemic” seemed to have dissipated as seasonal influenza activity in the United States remains lower than usual. This time last year, close to 100 times as many flu cases had been identified from nearly the same"...Read more

When it comes to health care, President Donald Trump has promised far more than he has delivered. But that doesn’t mean his administration has had no impact on health issues — including the operation of the Affordable Care Act, prescription drug prices and women’s access to reproductive health services............ Continue Reading

The Life Care Center of Kirkland, Washington, was the first COVID hot spot in the U.S. Forty-six people associated with the nursing home died, exposing how ill-prepared we were for the pandemic — and how we take care of our elderly. Published by The California Sunday Magazine........ Click to read

When COVID-19 smacked the United States in March and April, health plans feared medical costs could skyrocket, jacking up premiums drastically in 2021, when millions of the newly unemployed might still be out of work.

But something else happened: Non-COVID care collapsed as hospitals emptied beds and shut down operating rooms to prepare for an expected onslaught of patients sickened by the coronavirus, while fear of contracting it kept people away from ERs, doctors’ offices and outpatient clinics. In many regions of the country, the onslaught did not come, and the billions of dollars lost by hospitals and physicians constituted huge savings for health plans, fattening their bottom lines.

But that doesn’t mean consumers will see lower premiums next year.

Numerous insurers across the country have announced plans to hike rates next year, though some have proposed cuts.

Peter Lee, executive director of Covered California, appeared skeptical about premium reductions in the state’s Affordable Care Act exchange, which is likely to announce 2021 health plan rates next week.

“Would we like zero increases? Absolutely. Would we like them negative? Yeah — but not if that means you’re going to increase premiums in a year by 20%,” Lee said in an interview with California Healthline this week. “We’ve been leaning on them to do what we always lean on them to do, and this is to have the lowest possible rates where you won’t be on a rate roller coaster. We want health plans to price right — not to price artificially low or artificially high.”

Covered California provides coverage for about 1.5 million residents who buy their own insurance.

If the insurance exchanges in other states offer any guidance for Covered California, it is in the direction of moderate premium increases for 2021, though there is wide variation.

A KFF analysis last week of proposed 2021 rates in the exchanges of 10 states and the District of Columbia showed a median increase of 2.4%, with changes ranging from a hike of 31.8% by a health plan in New Mexico to a cut of 12% in Maryland. (Kaiser Health News, which produces California Healthline, is an editorially independent program of KFF.)

Among the roughly one-third of filings that stated how much COVID-19 added to premiums, the median was 2%, with estimates ranging from minus 1.2% at a plan in Maine to 8.6% at one in Michigan.

The proposed premiums for ACA marketplace plans do not affect job-based coverage, but they may indicate how the pandemic is affecting premiums generally.

The consensus among industry experts is that COVID-19 has generated little pressure for rate rises, and health plans should err on the side of moderation. But some fear that many insurers will hold onto the reserves they’ve built up, citing the possibility of widespread vaccinations and concerns that the care forgone in 2020 could rebound with a vengeance next year.

“The tendency of health plans, when they are faced with any degree of uncertainty, is to be very conservative and price for the worst-case scenario,” said Michael Johnson, an industry observer and critic who worked as an executive at Blue Shield of California from 2003 to 2015. “Actuaries are less likely to get fired if the plan prices too high than if the plan prices too low. But I think regulators really need to push back hard on that.”

Lee said all 11 insurers participating in the exchange this year will remain in 2021, and no new ones will be added to the mix, though some of the current carriers will extend their coverage geographically. Ninety percent of consumers who buy their own health insurance get subsidies from the federal government or the state to help pay their premiums.

In January, California became the first state to offer subsidies to middle-income people who make too much money to qualify for federal subsidies. The lion’s share of the state subsidies is earmarked for those who earn between 400% and 600% of the federal poverty level, or $51,040 to $76,560 a year for an individual and $104,800 to $157,200 for a family of four.

The rate proposals expected to be unveiled next week will be subject to scrutiny by state regulators before they are finalized. Sign-ups for the plans start Nov. 1 and run through Jan. 31. This year, the average Covered California rate increase statewide was 0.8%, the lowest since the exchange started providing coverage in 2014.

The benefits reaped by health plans so far in the pandemic can be seen in strong second-quarter earnings and reduced spending on care. UnitedHealth Group, the nation’s largest health insurer, announced earlier this month that its net profit in the April-June quarter nearly doubled from the same period a year earlier. Its medical spending plummeted from 83.1% of premium revenue to 70.2% over that period.

Anthem, the parent company of Blue Cross of California, reported Wednesday that its net profit in the second quarter doubled from the same period in 2019, also on the back of plunging medical expenses.

Anthem said it offered one-month premium credits ranging from 10% to 50% to enrollees in individual, employer and group dental policies — including its Blue Cross plans in California.

UnitedHealth said it has provided $1.5 billion worth of financial support to consumers so far, including premium credits and cost-sharing waivers, and expects to pay out $1 billion in rebates.

But UnitedHealth, which does not participate in Covered California, is seeking a rate increase of 13.8% in the New York exchange. Anthem, which covers about 80,000 people in Covered California, is planning rate hikes of 16.6% in Kentucky and 9.9% in Connecticut.

On the other hand, Kaiser Permanente, which covers more than one-third of Covered California enrollees, plans rate cuts in other states, ranging from 1% in Hawaii to 11% in Maryland. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)

Lee downplayed the notion of a financial boon for California health plans, saying that, partly because of the use of telehealth, primary care has rebounded and the plans are paying for it. “So we don’t see this as being at this point a bonanza year for health plans,” he said. “Rather, it’s a year in which there are lessons learned for how we can deliver care in a pandemic.”

Still, the health plans are in a far stronger position than they had feared earlier this year.

In March, Covered California released a study showing that COVID-19’s impact on 2021 premiums for individuals and employers could range from an increase of 4% to more than 40%. But less than three months later, projections commissioned by the industry’s national advocacy group, America’s Health Insurance Plans, showed that even in the worst-case scenario of a 60% COVID infection rate — far above where it stands now — the pandemic would increase medical costs in 2020 and 2021 by 6% at most, and could even decrease them.

That moderate effect is largely attributable to what Katherine Hempstead, a senior policy adviser at the Robert Wood Johnson Foundation, called “a kind of yin and yang: If you have a lot of COVID, you don’t have a lot of other health care spending.”

Independent of the course the pandemic takes, emergency room and outpatient visits still lag behind pre-COVID levels and will probably continue to do so next year, to the continued benefit of insurers, predicted Glenn Melnick, a professor of health care finance at the University of Southern California’s Sol Price School of Public Policy. That could be good news for consumers, he said, potentially leading to lower premium increases or even reductions next year.

On the other hand, hospitals and doctors have lost money, and the ones whose contracts with health plans are up for renewal will be looking to make up those losses, Melnick said.

“Providers could be asking for 20-25% increases next year,” he said, “and if they’ve got market power, they can make it stick.”

July 31, 2020

Stay away from People.
Large crowds, do avoid.
Act as if you lived
on an asteroid,
plummeting through the sky.
For this we believe,
is the way to be
and how we must live.
There is no need
to be with people, near,
so we live out our life
in a great, health fear,
of contracting a virus;
some say we could,
but avoiding everyone,
how can that be good?
Not good for socializing,
is certainly the word
for not seeing family
is just simply absurd.

Just as the number of people hospitalized for COVID-19 approaches new highs in some parts of the country, hospital data in Kansas and Missouri is suddenly incomplete or missing.

The Missouri Hospital Association reports that it no longer has access to the data it uses to guide state coronavirus mitigation efforts, and Kansas officials say their hospital data may be delayed.

The Trump administration this week directed hospitals to change how they report data to the federal government and how that data will be made available.

In an email, Missouri Hospital Association spokesperson Dave Dillon called the move “a major disruption.”

“All evidence suggests that Missouri’s numbers are headed in the wrong direction,” Dillon said. “And, for now, we will have very limited situational awareness. That’s all very bad news.”

The absence of the data will make it harder for health and public officials, as well as the general public, to understand how the virus is spreading.

“It’s hugely problematic,” said Dr. Karen Maddox, a public health researcher at Washington University in St. Louis. “The only way that we know where things are going up and where things are going down and where we need to be putting resources and where we need to be planning is because of those data.”

The White House instructed hospitals to report data to the Department of Health and Human Services through a new system created by a Pennsylvania-based company, TeleTracking, instead of to the Centers for Disease Control and Prevention.

The directive came as a surprise to hospitals, according to Kansas Hospital Association spokesperson Cindy Samuelson.

“From our perspective, these changes are big,” Samuelson said. “We only found out Tuesday, and we had to update the data by Wednesday night — so, less than 48 hours.”

The Missouri Hospital Association currently does not have access to the new HHS system, according to Dillon. He said the new system is also significantly different from the CDC system.

“The new datasets for reporting are not identical and in several cases are ill-defined,” Dillon said. “That has complicated hospitals’ efforts.”

In the wake of the announcement, the Missouri Department of Health and Senior Services posted a notice on its website this week that the daily and weekly updates on hospitals, including the numbers of people hospitalized and the availability of standard hospital beds, ICU beds and ventilators, would be temporarily halted.

“Missouri Hospital Association (MHA) and the State of Missouri will be unable to access critical hospitalization data during the transition. While we are working to collect interim data, situational awareness will be limited,” the notice on the department’s website says.

Dillon said the hospital association hopes to have “within a few days or weeks” hospital and coronavirus data that had been available through the CDC.

“However, in the short term, we’ll be very much in the dark,” Dillon said.

The hospital association will create an alternative reporting system for hospitals, according to Dillon, and plans to continue producing weekly reports, despite the uncertainty about data.

The Missouri Department of Health and Senior Services did not respond to inquiries regarding the data.

Kansas health officials are still able to access hospital and coronavirus data through the CDC and TeleTracking, according to Kansas Department of Health and Environment spokesperson Kristi Zears.

However, Kansas Hospital Association spokesperson Samuelson said the Kansas hospital data may be delayed if it is incomplete.

“If we’re not able to get a bulk of our members converted and uploading, I’m not sure we want to show it because then it will look like things have gotten a lot better,” Samuelson said.

The most recent data shows that as of July 12, 875 Missourians were hospitalized with COVID-19, among the highest reported numbers since an early May peak of 984. Kansas’ most recent data shows 1,393 people have been hospitalized with the disease.

The Trump administration said the reporting change was needed due to reporting delays and other problems with the CDC.

But the move has been widely criticized for being disruptive, especially as COVID-19 infection numbers reach new highs and hospitals in some areas of the country are reaching capacity.

“By now, we should have a foolproof, streamlined reporting system for COVID,” Maddox said. “And this change — midstream — is not going to do anything to help our ability to fight the disease.”

This story is part of a partnership that includes KCUR, NPR and Kaiser Health News.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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