Is how the DEA enforces the CSA… in violation of this federal law ?

Posted on May 26, 2022 by Pharmaciststeve

Currently there is a case before SCOTUS Ruan v. United States

that is trying to resolve this Issue: Whether a physician alleged to have prescribed controlled substances outside the usual course of professional practice may be convicted of unlawful distribution under 21 U.S.C. § 841(a)(1) without regard to whether, in good faith, he “reasonably believed” or “subjectively intended” that his prescriptions fall within that course of professional practice.

Within the Controlled Substance Act (CSA), it is illegal for a person to obtain a controlled substance without a valid medical reason. Historically, the DEA tried to trace back a OD/dead body back to a prescriber, didn’t seem to matter that the person that OD had not be seen by the prescriber for up to a year OR MORE.  The DEA charged the prescriber for prescribing opiates for someone without a valid medical necessity. Opiate Rxs peaked in 2011-2012 and they have been reduced by abt 60% since then.  Apparently “dead bodies’ that could be attached to a prescriber and opiate Rx, the DEA shifted to doing data search of those prescribers who were “believed” to be prescribing opiates for non-medical reasons.  The DEA – apparently to justify their conclusion – would publish how many doses of opiates – typically in millions – over a period of time – typically YEARS – and how many pts – typically in thousands…the prescriber had prescribed.

People – like me – would reverse engineer the numbers the DEA provided and in many instances … it would calculate that the “average pt” may have received a SINGLE DOSE every DAY OR TWO and I would share my findings on my blog and other places on the internet.

Over recent years, I have not seen any person that the DEA claimed the prescriber was providing opiates to that did not have a valid medical necessity getting arrested and sent to jail.  There have been rumors over the years, that the DEA would find a “bogus pt” in a particular practice and promise that person a free “get out of jail card” if they testify against the prescriber precisely what the DEA wants to be said under oath when the DEA takes the prescriber to Federal court.

Of course, the DEA is mostly interested in using the Civil Asset Forfeiture Act to confiscate all the prescriber’s assets.  So the prescriber has no income and no assets and the DEA has GROSSLY OVER CHARGED the prescriber, so going to trial with a public defender and facing so many years that a guilty verdict would pretty much means a LIFE SENTENCE… so the prescriber has no choice but to plead guilty to a SINGLE CHARGE and 20 yrs in jail and the bogus pt doesn’t have to perjure themself at trial and can’t admit to what they have done.

And all those legit pts in the prescriber’s practice is left “out in the cold”, because no other practice who wants to take a chance of accepting one of those pts from a “dirty practice” into their practice. Is the manner in which the DEA is enforcing the CSA, actually interfering with those pt’s medical care?

If you notice, 42 USC 1395 was added to our FEDERAL LAW in 1965 – FIVE YEARS before the CSA was signed into law and EIGHT YEARS before the DEA was created to enforce the CSA. Does this suggest that the Congress that passed the CSA and was signed into law by Pres “Tricky Dick” Nixon was technically signing into law a unconstitutional bill ?

42 USC 1395: Prohibition against any Federal interference

https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395%20edition:prelim)

From Title 42-THE PUBLIC HEALTH AND WELFARE CHAPTER 7-SOCIAL SECURITY SUBCHAPTER XVIII-HEALTH INSURANCE FOR AGED AND DISABLED

§1395. Prohibition against any Federal interference

Nothing in this sub chapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added Pub. L. 89–97, title I, §102(a), July 30, 1965, 79 Stat. 291 .)


Statutory Notes and Related Subsidiaries

Short Title

For short title of title I of Pub. L. 89–97, which enacted this subchapter as the “Health Insurance for the Aged Act”, see section 100 of Pub. L. 89–97, set out as a Short Title of 1965 Amendment note under section 1305 of this title.

Protecting and Improving Guaranteed Medicare Benefits

Pub. L. 111–148, title III, §3601, Mar. 23, 2010, 124 Stat. 538 , provided that:

“(a) Protecting Guaranteed Medicare Benefits.-Nothing in the provisions of, or amendments made by, this Act [see Short Title note set out under section 18001 of this title] shall result in a reduction of guaranteed benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].

“(b) Ensuring That Medicare Savings Benefit the Medicare Program and Medicare Beneficiaries.-Savings generated for the Medicare program under title XVIII of the Social Security Act under the provisions of, and amendments made by, this Act shall extend the solvency of the Medicare trust funds, reduce Medicare premiums and other cost-sharing for beneficiaries, and improve or expand guaranteed Medicare benefits and protect access to Medicare providers.”

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Medicine & Law Cannot Get Along

Posted on May 25, 2022 by Pharmaciststeve

Medicine & Law Cannot Get Along

https://www.daily-remedy.com/medicine-law-cannot-get-along/

We see a growing discrepancy between what most Americans understand healthcare to be, and what forms the philosophical basis of the Constitution. It leads to riots on the streets and vitriolic policy debates, particularly for polarizing healthcare issues.

The problem is neither side is entirely wrong. Regardless of whether the issue may be vaping, abortions, or prescription opioids, most are complex enough to justify nearly any stance. This is because healthcare and the Constitution as we currently interpret it are fundamentally incompatible.

“In Europe, the charters of liberty have been granted by power; America has set the example of charters of power granted by liberty”, said Founding Father and fourth President, James Madison. He was talking about the nature of rights in the then nascent United States.

Rather than a government giving rights to its people, the United States would assume that all Americans had pre-existing, unalienable rights “endowed by their Creator” and the American government would merely restrict certain rights in the name of public good.

Political scientists call these negative rights. In contrast, positive rights provide something or assume some obligation from the government to its people. Needless to say, healthcare as we understand it is derived from positive rights.

The problem is the Constitution is written to align philosophically with negative rights. The right to bear arms is considered an unalienable right, so the Constitution cannot restrict that right from people. Abortion was outlawed by English Common Law, so the writers of the Constitution, referencing Common Law, never saw abortion as an unalienable right.

This is why you hear so many anti-abortion policy wonks claim the Constitution never guaranteed the right to an abortion or assumes any provisions in protecting that right. They understand the Constitution is based on negative rights, restricting rights already assumed innate to all peoples.

To then turn around and claim that abortion should be protected violates the ethos of the Constitution and of the Common Law precedent that serves as the conceptual basis for it.

So who is right and who is wrong? Are those who steadfastly heed to the negative rights principle of the Constitution right? Or is it that those who intimately understand the modern socioeconomic constraints driving women toward abortions?

Attributing binary labels of right or wrong to any stance on a healthcare issue has proven to be counterintuitive at best. What would make more sense is analyzing how we can integrate positive rights beliefs underlying healthcare with a legal framework based on negative rights. In other words, how can we integrate healthcare into the framework of the Constitution?

There are two methods. The first is to concretely define the unalienable rights that constitute healthcare. European philosopher Henri Frederic Amiel wrote: “In health there is freedom. Health is the first of all liberties.” So conceivably, we would categorize healthcare as a liberty to be further elaborated, or enumerated, to use the most Constitution-friendly terms.

The problem with this approach is that we are already doing it. We ceaselessly chase our own tails arguing preconceived stances that we already believe. Some will say the right to pain relief is a fundamental liberty. Others will say the right to life, in all instances of life, is true liberty. We moralize our gut feelings through grandiose prose until our voices grow horse. And we continue to argue and bicker.

The second, and more reasonable, approach is to construct laws in an affirmative manner, which means laws balance rights afforded with commensurate responsibilities or obligations. We already have something like this, only we do not call it a law, we call it insurance. Health insurance policies balance medical risks with monthly premiums or deductible payouts.

Most insurance policies are already federally administered. The leap to extend this affirmative balance found in insurances to all aspects of healthcare would not be difficult. In fact, it would be quite logical.

Instead of issuing blanket restrictions on abortions, the right to the medical procedure would be determined by socioeconomic constraints, individual harms, and broader social benefits – and administer rights with responsibilities accordingly.

The Constitution has made provisions for such laws in the Fourteenth Amendment. Included within it are two core doctrines that serve as the basis for this type of law – Fundamental Fairness and Equal Protection of the Law.

These are abstract concepts, which have been formalized to enact laws like those that ushered in the Civil Rights Movement and fair immigration practices. Perhaps it is time we apply those concepts to healthcare.

So we can once and for all codify what we mean by rights in healthcare – not as a restriction, but as a balance.

 

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Your pharmacist might be permanently out to lunch

Posted on May 25, 2022 by Pharmaciststeve

Your pharmacist might be permanently out to lunch

https://thehill.com/opinion/healthcare/3499767-your-pharmacist-might-be-permanently-out-to-lunch/

CVS and Walgreens are limiting the amount of baby formula you can buy — a grim reminder of what shortages mean, and how dependent we have become on retail chains, especially when it comes to vital supplies, including drugs. 

Maybe you have noticed that it is getting crowded in CVS or Walgreens these days as you wait for an item, a vaccine or medication.  

Maybe you’ve been on hold for a pharmacist and finally given up. Perhaps you have argued with a pharmacist or been standing on a long line while someone else demanded better service from the pharmacist.

Within the major drug store outlets, you often see a sign that says, “We’re Hiring.” What I never considered is that the people they most need to hire are critical to our health.

Recently I was living in Massachusetts and went to pick up a prescription at my local Walgreens. A sign on the pharmacy counter read, “Closed for the weekend” with a list of nearby locations. I subsequently learned that the pharmacy was closed because of a shortage of pharmacists. And COVID-19 was not the culprit.

I did a bit of research, including a long chat with a pharmacist. It turns out my experience with a closed pharmacy was just one of many across the nation.

Here’s what I learned.

Pharmacists in America are struggling, and many are leaving the profession. Over the next 10 years, it is estimated that America will see a nationwide decline of at least 2 percent of its pharmacists, according to the Bureau of Labor and Statistics.

That might not sound like a lot until you consider that new prescription growth in the United States is off the charts. Last March, the volume of prescriptions increased 34 percent over the previous year. Much of that is mail-order prescriptions, which don’t require a pharmacist. But there are certain things that require a human pharmacist, including vaccines, advice on side-effects of medication, help with finding a generic brand to reduce costs and even what to do if you can’t find baby formula. Pharmacists are also wizards at dealing with insurance companies on your behalf.

The problem for pharmacists today, I learned, is not wages. A good pharmacist can earn $75 an hour. Not bad.

The problems have to do with working conditions for pharmacists. One pharmacist at a leading chain told me he does not drink water before his 13-hour shift because there is no time to use the bathroom. The phones are ringing off the hook. Angry customers are demanding refills. And the average pharmacist is backed up trying to prioritize competing demands for antibiotics and inhalers. Volume is up, staffing is down.

Unruly airline passengers got the lion’s share of attention this year while pharmacists were facing angry customers of their own. It is time to admit that Americans have become increasingly short-tempered.

What worries many pharmacists is that dismal conditions can lead to mistakes, accidents and shortages. A 2022 survey by the American Pharmacist Association found that 74 percent of respondents said they did not think they had sufficient time to safely perform patient care and clinical duties.  

The pharmacist shortage comes at a time when COVID infections are up and the supply of nurses and medical technicians is down.  According to the American Hospital Association, almost every hospital in the country has a nursing shortage due to burn out from COVID. One study found that 35 percent of hospitals report a nurse vacancy rate of greater than 10 percent. Whether or not you believe in vaccines is not relevant if you need medication or medical attention or vital goods.

Yes, we know. The American health care system is broken. There is no shortage of reports and commissions looking at America’s health crisis. The answers about how to fix the health system are as complex as the system itself.  

But the narrow sector of pharmacists is a good place to start reform. Major companies like CVS, Walgreens and RiteAid need to staff their stores with more qualified people to ease the burden on existing staff. They can afford it. CVS posted a profit last year of $7.9 billion — up over 10 percent from the year before. Walgreens also had a good year.

Another answer to the pharmacy problem might be to put some of the burden for vaccination back on the internists who have quietly avoided COVID by telling patients to take home tests or get vaccinated at their local pharmacy.  

Ultimately, we all want to support small, local businesses, including the neighborhood pharmacy. But we still turn to the big chains, confident that they will be open and well-staffed and have products on the shelves. In this era of increasing resignations, it is not helpful to have pharmacists resign anywhere in the country.  

Tara D. Sonenshine is the Edward R. Murrow Professor of Public Diplomacy at The Fletcher School of Law and Diplomacy at Tufts University.

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Judiciary Committee Leaders Press Justice Department for Overdue Answers on DEA Foreign Operations

Posted on May 25, 2022 by Pharmaciststeve

Judiciary Committee Leaders Press Justice Department for Overdue Answers on DEA Foreign Operations

https://www.grassley.senate.gov/news/news-releases/judiciary-committee-leaders-press-justice-department-for-overdue-answers-on-dea-foreign-operations

WASHINGTON – Sens. Chuck Grassley (R-Iowa) and Dick Durbin (D-Ill.), respectively ranking member and chair of the Senate Judiciary Committee, are seeking additional information about the Drug Enforcement Administration’s (DEA) oversight of its foreign operations, including the closure of a special DEA unit in Mexico that Mexican officials claim was infiltrated by criminals. The senators’ letter follows an unanswered inquiry from last November.
“After more than six months, and despite multiple follow-up requests from both of our offices, we have received neither the briefing we requested nor a response to our November 16, 2021, letter. By any measure, such an extended delay is unacceptable,” the senators wrote. “…Furthermore, recent developments in Mexico raise additional concerns and speak to an ongoing need for congressional oversight.”

In their letter to DEA Administrator Anne Milgram, the senators voice serious concerns about the DEA’s lack of engagement with its committee of jurisdiction and outline concerns stemming from the Mexican president’s announcement that a DEA sensitive investigative unit operating in Mexico was closed last year. Other media reports describe this unit as “deeply dysfunctional and constantly leaking to the cartels.”  The senators also ask the DEA to explain the circumstances surrounding the reported removal of an airplane used in DEA missions against drug cartels. This is the latest in a series of longstanding concerns about DEA’s oversight of its overseas operations.

An August 2021 report by the Justice Department’s Office of Inspector General (OIG) and a report from U.S. Office of Special Counsel (OSC) raised serious concerns about the lack of oversight of DEA operations abroad. Grassley and Durbin sought specific information about the status of some of these operations and the steps being taken to comply with OIG’s recommendations in November 2021. They raised specific concerns about operations involving a leak in Mexico, agents fraternizing with prostitutes in Colombia and two DEA-associated individuals in Haiti arrested or wanted by authorities in connection with the assassination of that country’s president. The senators have not received any substantive response from the DEA.
Full text of Grassley’s and Durbin’s letter to DEA can be found HERE.

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Covid-19 deaths DOWN 1.2% HEADLINE: HOSP admissions increased 24% this week

Posted on May 22, 2022 by Pharmaciststeve

COVID-19 admissions increased 24% this week: 9 CDC findings

https://www.beckershospitalreview.com/public-health/covid-19-admissions-increased-24-this-week-9-cdc-findings.html

The nation is now reporting more than 100,000 COVID-19 cases daily as hospitalizations continue to rise nationwide, according to the CDC’s COVID-19 data tracker weekly review published May 20.

Nine findings:

Cases

1. As of May 18, the nation’s seven-day case average was 101,130, an 18.8 percent increase from the previous week’s average. 

Hospitalizations 

2. The seven-day hospitalization average for May 11-17 was 3,250, a 24.2 percent increase from the previous week’s average. This marks the sixth consecutive week hospitalizations have increased.

Deaths

3. The current seven-day death average is 280, down 1.2 percent from the previous week’s average. Some historical deaths have been excluded from these counts, the CDC said. 

Vaccinations

4. The seven-day average number of vaccines administered daily was 388,308 as of May 18, a 0.5 percent decrease from the previous week.

5. As of May 18, about 258 million people — 77.7 percent of the U.S. population — have received at least one dose of the COVID-19 vaccine, and more than 220.7 million people, or 66.5 percent of the population, have received both doses. 

6. About 102.4 million additional or booster doses in fully vaccinated people have been reported. However, 49.1 percent of people eligible for a booster dose have not yet gotten one, the CDC said.

Variants

7. Based on projections for the week ending May 14, the CDC estimates the BA.2 omicron subvariant accounts for 50.9 percent of U.S. COVID-19 cases, while BA.2.12.1 accounts for 47.5 percent. Other omicron subvariants make up the rest.

Testing

8. The seven-day average for percent positivity from tests is 10.6 percent, up 2.01 percentage points from the previous week. 

9. The nation’s seven-day average test volume for May 6-12 was 798,164, up 0.9 percent from the prior week’s average. 

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When a pain management practitioner – really could care less about really trying to manage a pt’s pain

Posted on May 21, 2022 by Pharmaciststeve


I had a interesting conversation with a chronic pain pt yesterday. This pt shared with me a 18 minute recording of a office visit with a mid-level practitioner. This is suppose to be a pain practice and this pt has a torturous level of pain in each shoulder from two separate accidents.  The pain is so intense that the pt has very little use of both of their arms.   Just imagine the difficulty a person would have in doing personal care and/or simple chores around one’s house. Especially since the pt lived alone.

This mid-level did not ask what the pt’s level of pain was, but told the pt that they were at the max dose by the CDC of opiates and that she was on Xanax (Alprazolam) and he referenced the Beers Criteria https://www.aafp.org/afp/2020/0101/p56.html and the risk that Beers stated was hazardous to cause falls and other MAYBE SIDE EFFECTS.  But Beers is specifically directed towards those 65+ y/o and this pt was 61 y/o.

What the pt told me that they were prescribed was NO WHERE NEAR the CDC guidelines of 90 MME/day and this was a pain practice, so those limits do not apply to pain specialists.

The pt point out to the mid-level that the CDC were only guidelines – which the mid-level acknowledged, but the managing MD over the practice had implement max daily MME levels that what he consider “safe”.  That OLD ONE SIZE FITS ALL.

The pt is going to try to find a new pain management practice and I suggested once they have left this practice to file a complaint with the Quality Improvement Organization (QIO) and when they get reviewer’s report back. If the reviewer believes that the pt was not properly treated. Take that report and file a complaint with the state AG’s office on the MD and the mid-level in the practice and file a complaint with CMS about the pt’s Medicare’s Advantage Prgm

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Roe vs wade: how could it help/hurt the chronic pain community

Posted on May 21, 2022 by Pharmaciststeve


https://www.foxnews.com/politics/what-is-roe-v-wade-leaked-supreme-court-draft-opinion

The 1973 landmark decision made abortion legal for women during their first trimester of pregnancy

Option 1: There has been a leak concerning that the SCOTUS is going to overturn Roe vs Wage.. If this comes to pass then an abortion falls back to the states rules/laws. Senator Manchin recently stated that there are abt 500 state laws on the books concerning abortions.

Option 2: The SCOTUS lets Roe vs Wade stand

Option: 3: Congress passes a bill that would make abortions legal and basically negates the 500 state laws that exists. Congress could put time limits that matches the first trimester that Roe vs Wade supported or make abortions legal until a woman goes into labor, or anywhere in between.

Unless Congress codifies that abortions are legal,  the protests are going to continue… with “My body, My choice”… and this past week a woman testified before a Congressional hearing https://www.msn.com/en-us/news/politics/abortion-witness-tells-congress-men-can-get-pregnant-and-have-abortions/ar-AAXrrRr

so, if this is true… everyone should be able to protest abt  “my body, my choice” and should be able to get medication to properly manage their pain ?

As I remember our Founding Fathers in our Declaration stated that we have the unalienable rights – Life, Liberty and the pursuit of Happiness – which the Declaration says have been given to all humans by their Creator, and which governments are created to protect.

I may be wrong, but from this statement, our Founding Fathers did not intend for their successors to REDEFINE – OR MICROMANAGE -THOSE UNALIENABLE RIGHTS.

Without proper pain management – NONE OF THOSE UNALIENABLE RIGHTS are attainable and the governments are doing more interring with than protecting ?

 

 

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IV Tylenol Flops In Yet Another Pain Trial—To No One’s Surprise

Posted on May 20, 2022 by Pharmaciststeve

IV Tylenol Flops In Yet Another Pain Trial—To No One’s Surprise

https://www.acsh.org/news/2022/05/20/iv-tylenol-flops-yet-another-pain-trial%E2%80%94-no-ones-surprise-16319

For reasons I cannot fathom, we are treated to yet another clinical trial about IV Tylenol and whether it can decrease the amount of morphine needed by pain patients in the ER. Here’s your hint: No.

Image: Wikimedia Commons

Since I am nothing if not subtle, I was perfectly comfortable writing IV Tylenol As Good As Moose Urine For Post-Op Pain Control back in 2019, when I dissected a study that clearly showed that IV acetaminophen was thoroughly worthless in controlling post-operative pain following spinal surgery.

I fear that I will run out of ruminants long before IV Tylenol pushers run out of different body parts to study, hence the vegan title on this one.

So, what’s today’s Tylenol flop du jour? It’s a study (1) in the journal Academic Emergency Medicine that makes short order of the question: “Can IV Tylenol reduce the amount of morphine needed by patients who visit emergency departments for pain relief?” (2)

You already know where this is going so I’ll keep it short. 

The Study

  • 220 patients who visited the emergency department at Cantonal Hospital of St. Gallen in Switzerland were randomized into two equal groups, placebo and intervention (treated with Tylenol).
  • Both groups were blinded.
  • All had a Numerical Rating Pain Scale score of 4 or higher.
  • Patients in the morphine-only group received 0.1 mg of morphine per kilo of body weight) plus placebo (IV).
  • Patients in the treatment group received 0.1 mg of morphine per kilo of body weight plus 1.0 grams of Tylenol (both IV).
  • All the patients were dosed every 15 minutes until their pain scores were reduced to less than 4.

The Results (such as they are)

  • The Tylenol-plus-morphine group required a mean morphine dose of 0.15 mg ± 0.07 mg/kg and a total dose of 13.1 mg.
  • The morphine-only group required a mean morphine dose of 0.16 mg ± 0.07 mg/kg and a total dose of 11.7 mg.
  • These numbers are the same.

Other measured outcomes included the time required to control pain, the time for it to reoccur, and the frequency of side effects. Same. Same. Same.

The group also broke down the pain into different categories. Likewise, within these subgroups, there was (big surprise) no difference between the morphine and morphine + Tylenol groups:

Same. Same. Same. Same. Same. Same. Same.

  • No one got addicted (2).

Conclusions:

Let’s have the authors speak for themselves:

 In ED patients, acetaminophen had no additional effect on pain control or morphine sparing effect at the time of first morphine administration. Titrated morphine with the algorithm used was highly effective, with 80% of all patients reporting pain relief within 60 minutes of starting therapy.

Minotti, et. al.,  Acad Emerg Med (2022 May 2), doi: 10.1111/acem.14517. Online ahead of print.

Seriously, Folks

Don’t you think that it’s about time to knock this off? Do we really need to conduct more studies in the desperate attempt to find some use for Tylenol, especially if it can result in a reduction of one-bazillionth of a milligram of morphine? Knock it off. Please. I’m begging you.

NOTES:

(1) It’s probably no accident that this trial took place in Switzerland. I can almost hear the screaming voices of the hoards of people who went to EDs with legitimate pain from legitimate medical issues only to be sent away with a healing crystal and pack of Tylenol (they work equally well). 

(2) Although I just made this up, I’m pretty sure no one got addicted from a lousy 17 mg of morphine. In fact, I’m so sure that I’m willing to bet my IRA against that of Dr. Andrew “Big Bling” Kolodny, who probably believes otherwise.

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Feds Ask for Covid-19 “Misinformation” — Indiana Attorney General Sends Them CDC Remarks

Posted on May 20, 2022 by Pharmaciststeve

Feds Ask for Covid-19 “Misinformation” — Indiana Attorney General Sends Them CDC Remarks

https://thenewamerican.com/feds-ask-for-covid-19-misinformation-indiana-attorney-general-sends-them-cdc-remarks/

When the U.S. Surgeon General’s office asked states to supply it with examples of Covid-19 misinformation, it probably did not expect what it got from Indiana Attorney General Todd Rokita: a list of false statements from Centers for Disease Control and Prevention (CDC) officials.

Rokita’s letter, dated May 2 but released to the public Monday, was compiled with the help of his co-signatories, Stanford University medical professor Jay Bhattacharya and former Harvard University medical professor Martin Kuldorff.

In their letter, the three “agree” with the Surgeon General “that misinformation has been a major problem during the pandemic,” but they contend that much of the misinformation has come “from the CDC and other health organizations.” To prove it, they cite several categories of such disinformation.

First on the list is the vast overcounting of Covid-19 deaths and hospitalizations. “CDC has not distinguished deaths where COVID-19 was the primary cause of death, where COVID-19 was a contributing cause of death, or where the death was entirely unrelated to COVID-19, but they incidentally tested positive,” the authors write. Various studies, which they cite, have shown that Covid-19 prevalence has been overcounted in both the United States and other developed countries.

Officials downplayed or denied that natural immunity exists while pushing the vaccines partly on the basis that they would prevent transmission of the virus. These assertions were baseless given that the existence of natural immunity was established early in the pandemic and that the vaccine trials “were not designed to determine whether they could also limit transmission or prevent death,” the letter reads.

School closures harmed children, potentially for the long term, without providing any real benefits, assert Rokita and company. The decision to shutter schools, they note, “was based on false claims that it would protect children, teachers, and the community at large.” Yet Sweden’s example of keeping schools — and most of the rest of society — open with no negative consequences put the lie to such notions by mid-2020, even as U.S. school closures dragged on.

Officials’ suggestions that “everyone is equally at risk … from COVID-19 infection” when, in reality, “there is more than a thousand-fold difference in the risk of hospitalization and death for the old relative to the young,” led the public to wildly overestimate the dangers of the virus and to demand lockdowns and other harmful policies, says the letter.

The authors also criticize the notion that “there was no reasonable policy alternative to lockdowns,” pointing to their recommendations in the Great Barrington Declaration and again to Sweden, which has “had near-zero overall excess death” during the pandemic. “Lockdowns,” they declare, “are an aberration — a sharp deviation from traditional public health management of respiratory epidemics — and a catastrophic failure of public health policy.”

“Contrary to assertions by some public health officials, mask mandates have not been effective in protecting most populations against COVID-19 risk,” write the three men. Cloth masks are useless, and even N95s have only limited effectiveness, particularly when worn by untrained individuals.

Mass testing of asymptomatic persons combined with contact tracing and quarantining, the letter argues, have “failed to substantively slow the progress of the epidemic” but have “imposed great costs.” Asymptomatic individuals rarely pass the disease on to others, the PCR tests are flawed, and tracing the contacts of everyone who tests positive overwhelms the system. “In the U.K., an official government review determined that its 37 billion pound investment in contact tracing was a waste of resources.”

Finally, the authors scold “public health leaders” for making “the suppression of COVID-19 spread to near-zero levels the endpoint of the pandemic” because “SARS-CoV-2 has none of the characteristics of a disease that can be eradicated.” The technology to eradicate it does not exist, lockdowns are unfeasible and would have to be imposed worldwide even to have a chance of being effective, the vaccines lose efficacy over time, and many animals can host the virus and transmit it to humans.

If the CDC wants to be taken seriously again, it ought to heed the words of Rokita’s missive because, as he and his co-authors observe, the government’s falsehoods regarding Covid-19 “have shattered the public’s trust in science and public health and will take decades to repair.”

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CMS Proposal to Suppress Hospital Safety Data Angers Advocates

Posted on May 20, 2022 by Pharmaciststeve

CMS Proposal to Suppress Hospital Safety Data Angers Advocates

Agency says COVID disruptions, staff shortages hamper ability to fairly score poor performers

https://www.medpagetoday.com/special-reports/exclusives/98843

Large employer coalitions and consumer advocates are angrily pushing back against a Centers for Medicare & Medicaid Services (CMS) proposed rule to suppress public reporting of key measures of preventable hospital-caused harms, such as pressure ulcers or falls resulting in hip fractures.

If the rule is finalized, CMS would not calculate scores under the Hospital-Acquired Condition Reduction Program (HACRP). Hospitals would still report on some safety measures, but certain scores — in particular those for the 10-measure Patient Safety and Adverse Events Composite (PSI 90), a key component of the HACRP — would be hidden from public data files and would not appear on the CMS Hospital Compare website.

Furthermore, CMS would not dock hospitals in the worst-performing quartile 1% of their Medicare reimbursement, as it usually does, and would end up paying these hospitals what would normally be withheld — an estimated $350 million — an amount that would be lost to the Medicare trust fund.

The agency gave several reasons — all related to COVID-19 — why hospitals need to be let off the hook, including wide variation in performance scores; unprecedented changes in clinical guidelines, treatments, and drugs; and rapid changes in what clinicians understand about a pathogen of unknown origin. In particular, they noted huge shortages of healthcare personnel and high rates of burnout, specifically among nurses, which could affect a variety of measures, such as infection rates and avoidable falls.

CMS began suppressing some measures at the beginning of the pandemic in 2020, and many assumed that would be the end of it.

‘Outrageous’ and ‘Ludicrous’

The CMS proposal “is outrageous,” Bill Kramer, executive director for health policy at the Purchaser Business Group on Health, told MedPage Today.

“Patients will be unable to know whether the provider they want to go to has more patient safety problems, more risky providers, so clinicians as well as purchasers and policymakers will be unable to identify and help patients choose those hospitals with the best patient safety record,” he said. Without that information, patients are more likely to suffer from avoidable accidents, “and some of them will die as a result.”

James Gelfand, executive vice president of public affairs for the ERISA Industry Committee, a trade association representing about 100 of the nation’s largest self-insured employers who purchase health benefits for their employees and families, called the CMS proposed rule “ludicrous.”

“Essentially what they’re saying is that patients got treated badly, so they’re going to report badly, and so the hospitals are going to score badly. And, therefore, we have to keep the data secret,” he said.

“The federal government has data that would be really useful in making decisions about plan design and decisions about whether to steer people to a particular hospital or health system, but they’re not going to give it to you because it’s bad for the hospitals? I can’t express to you how alarming that is,” he noted.

Leah Binder, president and CEO of the Leapfrog Group, which uses the CMS data to score hospitals with safety grades from A to F, told MedPage Today that she worries that not only will this proposed rule be finalized, but that CMS will extend the suppressed public reporting indefinitely, because they don’t want “to make hospitals unhappy with them.”

“The American public trusts hospitals to deliver care, and not to cause them to suffer unnecessarily,” she said. “As a hospital or as a hospital worker, you have a job that’s difficult, that requires you to keep your patients safe.”

“It scares me,” she continued. “I know enough to be frightened … if hospitals are not able to manage their operations in order to protect their patients.”

However, a spokesman for the American Hospital Association told MedPage Today, “we agree with the agency that it would be unfair to base hospital performance on data that have been distorted by the pandemic.”

“To the best of our knowledge, the current methodologies for most quality report cards that use CMS quality measurement program data are based on individual measures, and not the overall scores from the HACRP and Hospital Value-Based Purchasing program,” the spokesman wrote in an email.

PSI 90

The PSI 90 score measures in-hospital serious and potentially fatal pressure ulcers, falls resulting in hip fracture, and several preventable postoperative complications, such as sepsis, respiratory failure, and hemorrhage. CMS proposed to suppress individual metrics for each, meaning that consumers would not be able to compare, for example, an individual facility’s postoperative pulmonary embolism rates or perioperative hemorrhage rates.

Binder pointed to a February 17 Perspective in the New England Journal of Medicine, authored by CMS and CDC officials, which showed that after years of quality improvement on a variety of safety measures, infections and other complications soared during the pandemic, completely reversing the progress that had been made.

For example, central line-associated bloodstream infections decreased 31% in the 5 years before the pandemic, a trend “totally reversed by a 28% increase in the second quarter of 2020,” the authors wrote. Increases were also reported in catheter-associated urinary tract infections, ventilator-associated events, and methicillin-resistant Staphylococcus aureus bacteremia.

These are some of the very measures whose scores will no longer be available to the public under the agency’s proposed rule, Binder pointed out.

Kramer said that PSI 90 scores are also used by insurers and employers to identify preferred provider networks and to monitor quality of care, so they can let employees know if there’s a problem with a particular hospital or system.

Nurse Burnout

Nurse burnout and personnel shortages could negatively affect the way patients respond to CMS-required Hospital Consumer Assessment of Healthcare Providers and Systems surveys on how they perceived the quality of their care, which CMS proposed to suppress because of hardships during the pandemic.

Because patient volumes and personnel shortages affected facilities’ rates of adverse events, the agency noted that they are “concerned … that we will not be able to score hospitals fairly or reliably for national comparison and payment adjustment purposes.”

However, Binder said that she is adamant that hospitals with poor quality scores should not be given a pass on accountability.

“If hospitals had a problem — that they didn’t have enough staff or had a high rate of problems with patient safety, that they were killing some patients — that needs to be made public and people need to know and be able to choose to not go to a hospital that’s under this kind of stress and is not safe,” she noted.

Gelfand and Binder said they understand that hospitals had staffing problems during the pandemic, and that in some facilities, a shortage of staff physically capable of assisting patients may have meant a higher number of complications, such as preventable falls.

“But when I judge a hospital, one of the things I judge them for is, are they able to roll with the punches,” said Gelfand. “And when I hear things like, ‘well, we dropped people because we made decisions about staffing,’ what I’m hearing is that they’re not capable of making decisions and planning to provide a safe environment.”

The proposed rule is also worrisome because it assumes that this pandemic is unique, and that hospitals won’t ever have to face such extreme circumstances again, he noted.

“As much as we would like to think that this is the only pandemic that we’re ever going to experience, that’s just not very likely. If the facts of the matter are that certain systems aren’t up to it, not able to keep people safe during a pandemic, we need to know that and they don’t have the right to keep that secret,” he said.

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