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posted by Fnord666 on Monday May 25 2020, @05:47PM   Printer-friendly
from the demonstrate-that-it-works dept.

US begins crackdown on unvetted virus blood tests:

U.S. regulators are moving ahead with a crackdown on scores of antibody tests for the coronavirus that have not yet been shown to work.

The Food and Drug Administration on Thursday published a list of more than two dozen test makers that have failed to file applications to remain on the market or already pulled their products.

The agency said in a statement that it expects the tests "will not be marketed or distributed." It was unclear if any of the companies would face additional penalties.

Most companies faced a deadline earlier this week to file paperwork demonstrating their tests' performance. Regulators required it after previously allowing tests to launch with minimal oversight, which critics said had created a "Wild West" of unregulated testing.

[...] Under pressure to increase testing options, the FDA in March essentially allowed companies to begin selling antibody tests as long as they notified the agency of their plans and provided disclaimers, including that they were not FDA-approved.

The FDA is now working with the National Institutes of Health and other federal health agencies to vet the accuracy of the tests and determine how they can be used to track and contain the virus.


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  • (Score: 2) by PocketSizeSUn on Tuesday May 26 2020, @06:57PM (1 child)

    by PocketSizeSUn (5340) on Tuesday May 26 2020, @06:57PM (#999335)

    Citation:
    https://www.factcheck.org/2020/04/hospital-payments-and-the-covid-19-death-count/ [factcheck.org]

    An analysis by the Kaiser Family Foundation looked at average Medicare payments for hospital admissions for the existing diagnosis-related groups and noted that the “average Medicare payment for respiratory infections and inflammations with major comorbidities or complications in 2017 … was $13,297. For more severe hospitalizations, we use the average Medicare payment for a respiratory system diagnosis with ventilator support for greater than 96 hours, which was $40,218.”

    And on top of that:

    The CARES Act created the 20% add-on to be paid for Medicare patients with COVID-19. The act further created a $100 billion fund that is being used to financially assist hospitals — a “portion” of which will be “used to reimburse healthcare providers, at Medicare rates, for COVID-related treatment of the uninsured,” according to the U.S. Department of Health and Human Services.

    So the oft repeated 13k and 39k are, factually, low estimates.

    As to miscoding? We only have anecdotal stories that I am aware of ...

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  • (Score: 0) by Anonymous Coward on Tuesday May 26 2020, @07:48PM

    by Anonymous Coward on Tuesday May 26 2020, @07:48PM (#999347)

    Your first quote:

    An analysis by the Kaiser Family Foundation looked at average Medicare payments for hospital admissions for the existing diagnosis-related groups and noted that the “average Medicare payment for respiratory infections and inflammations with major comorbidities or complications in 2017 … was $13,297. For more severe hospitalizations, we use the average Medicare payment for a respiratory system diagnosis with ventilator support for greater than 96 hours, which was $40,218.”

    makes it clear that the difference in costs are related to significantly different treatment regimens. Someone with respiratory complications is going to require expensive support. And those with even more serious complications (on a ventilator for extended periods) require *even more* expensive support, in terms of equipment, medications, human interaction, etc.

    I'd also note that not everyone with COVID-19 (or any other illness with respiratory complications) requires a ventilator, an ICU bed or the level of care that someone requiring extended use of a ventilator.

    As such, the difference in cost isn't surprising at all, and has nothing to do with whether or not someone has COVID-19 or not.

    What's more, from the link *you* posted [factcheck.org]:

    Numerous readers have asked us about such claims, some of which imply that hospitals are making money by simply listing patients as having the disease — when in fact the payments referenced are for treating patients. And while some of the posts imply that fraud may be afoot, multiple experts told us that such theories of hospitals deliberately miscoding patients as COVID-19 are not supported by any evidence.
    [...]
    The figures cited by Jensen generally square with estimated Medicare payments for COVID-19 hospitalizations, based on average Medicare payments for patients with similar diagnoses.

    Medicare — the federal health insurance program for Americans 65 and older, a central at-risk population when it comes to COVID-19 — pays hospitals in part using fixed rates at discharge based off a grouping system known as diagnosis-related groups.

    The Centers for Medicare & Medicaid Services has classified COVID-19 cases with existing groups for respiratory infections and inflammations. A CMS spokesperson told us exact payments vary, depending on a patient’s principal diagnosis and severity, as well as treatments and procedures. There are also geographic variations.
    [..]
    It is true, however, that the government will pay more to hospitals for COVID-19 cases in two senses: By paying an additional 20% on top of traditional Medicare rates for COVID-19 patients during the public health emergency, and by reimbursing hospitals for treating the uninsured patients with the disease (at that enhanced Medicare rate).

    That's not some nefarious plot to line the pockets of the hospitals, payments are in line with other, similar, respiratory illnesses with the exception of the statutory 20% premium during the crisis.

    What's more, that's Medicare patients and the uninsured. Medicaid recipients are not considered at all.

    As the link you posted clearly says:

    COVID-19. The act further created a $100 billion fund that is being used to financially assist hospitals — a “portion” of which will be “used to reimburse healthcare providers, at Medicare rates, for COVID-related treatment of the uninsured,” according to the U.S. Department of Health and Human Services.

    As the Kaiser analysis noted, though, “it is unclear whether the new fund will be able to cover the costs of the uninsured in addition to other needs, such as the purchase of medical supplies and the construction of temporary facilities.”''

    Either way, the fact that government programs are paying hospitals for treating patients who have COVID-19 isn’t on its own representative of anything nefarious.
    [...]
    Robert Berenson, an institute fellow at the Urban Institute, said the notion that hospitals are profiting off the pandemic — as some of the social media posts may imply — isn’t borne out by facts, either.

    Berenson said revenues appear to be down for hospitals this quarter because many have suspended elective procedures, which are key to their revenue, forcing some hospitals to cut staff. He surmised that potential instances of patients being wrongly “upcoded” — or classified as COVID-19 when they’re not — are “trivial compared to these other forces that are affecting hospital finances.”

    Berenson and others we spoke with also said that hospitals have profound disincentives for “upcoding,” which can result in criminal or civil liabilities, such as being susceptible to being kicked out of the Medicare program.

    You cherry-picked a couple of paragraphs and *completely* misrepresented the tenor and findings of the Factcheck article.

    Were you too stupid to actually read your citation, or are you just a lying sack of shit?