May is national health month

 

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what’s your story ?

A chronic pain pt asked if I would share their story…

So I am not only going to share this pt’ story,  I have created a NEW TAB on the first page of my blog and will put links to pt’s stories who share in the future

If you have a story you want shared sent it to steve@steveariens.com

HELP — HELP — HELP

Every week, sometimes multiple of times a day… I get emails, FB messages, phone calls from chronic pain pts that are being denied care and their medically necessary medication… sometimes from a prescriber, some from a pharmacy/pharmacist, insurance/PBM.

I am about to take on the task of being CFO for the non profit American Pain & Disability Foundation, so there is going to be one more alligator in my swamp…and I am getting tired/bored with giving out the same/similar advise over and over… hopefully after I finish this post they will read it first and/or if they don’t read it first..  I can just answer their question with referring them to this post first with a hyperlink.

FIRST THE PHARMACY/PHARMACIST

I often get some cryptic message about them being denied their medication – and I am suppose to fill in the blanks and come up with a recommendation.  Often, I am just replying with the same/similar words that I have routinely typed to other pts.

If the pt is going to a chain store… and you have been getting your meds without problem for months or years and all of sudden they are getting stonewalled.. Most likely, there has been a change in the staffing in the Rx dept of that store or they have encountered  a “floating pharmacist” that is working there for a day or week… covering a sick employee, a vacation, a pregnancy leave.  Often these Pharmacists don’t know your prescriber, don’t know you and won’t bother to look at your Rx records at the store…  JUST SAY NO…

They know that the pt calls HQ, they will be told that they stand behind their pharmacist’s decisions – can’t make a pharmacist to fill a Rx… probably get the same answer from the board of pharmacy.  They could ask the Pharmacist to provide the clinical information that they made their decision on… but.. that would create a virtually Tsunami of paperwork.

Another “reason” … “I’m not comfortable”… maybe the pt should ask the pharmacist what clinical information that he/she is not comfortable about ? – IMO “I’m not comfortable” is an EXCUSE not based on few if any FACTS.

Then there is a “we are out of stock”… what the Pharmacist hopes that the pt doesn’t know that the DEA requires that every pharmacy keep a hard copy PERPETUAL INVENTORY… Maybe the pt should document the date/time of being told that the pharmacy is out of stock and send a request to the pharmacy board to ask the pharmacy to provide a copy of the perpetual inventory sheet for the particular medication/strength for the particular day/time…  Does the Board of Pharmacy consider LYING TO PTS UNPROFESSIONAL CONDUCT ?  If the Board won’t go as far as getting this information – then they apparently don’t.

The pt will probably be told that the Pharmacist has a “corresponding responsibility” which is in the control substance act of 1970…  Just have to make sure that the medication is being prescribed for valid medical reason…  IMO, corresponding responsibility should be a “two way street” … make sure that medication does not get into the hands of someone that really doesn’t have a valid medical necessity and make sure that the medication gets in the hands of someone that does have a valid medical necessity..  But Pharmacists don’t have access to the pt’s medical records – other than the Rxs they have filled at the store and/or pulled a state PDMP report…  Pharmacists don’t have the legal right, nor training, nor physical space,  nor time to do a physical exam…  If they have not called and talked to the prescriber.. the information that the Pharmacist has is fairly limited… so many use the term “corresponding responsibility” to JUST SAY NO. They turn this term into a ONE WAY STREET TO JUST SAY NO !!!

Other than the state of Alaska, I know of no pharmacists that have experienced any bad consequences for JUST SAYING NO !!

Perhaps, a pt – being denied their medication… share this chart with the Pharmacist… this chart shows the comorbidity complication of under/untreated pain and if a pt is intentionally thrown into cold turkey withdrawal those complications will come on very quickly and probably very intensively…  Think hypertensive crisis, stroke, death… how would that affect the pharmacist’s license ?

The quickest path for a pt to get their medication is to find a independent pharmacy … where the pt will be dealing with the Pharmacist/owner who tend to be less judgemental.. here is a website to locate one by zip code https://ncpa.org/pharmacy-locator

DENIAL FROM A PRESCRIBER

More and more prescribers are no longer in a private practice. Their practice has been sold to large hospital system and they are just an employee of that corporation and what they will/won’t prescribe is more likely being dictated by their corporate employer.

It is best if chronic pain pts are proactive when they are first told that they are going to participate in a involuntary forced reduction in their meds.  IMO… waiting until you are way down the path of reducing their doses… it is probably too late to back things up  Here is a post that I did a few months ago that should give the pt some direction of actions that they may be able to take http://www.pharmaciststeve.com/?p=35002

Insurance/ PBM problems/denials

Many insurance company will hire a PBM ( Prescription Benefit Manager) to handle the adjudication of Rx claims… they provide you the “drug card”. There are a handful of PBM’s that control the lion’s share of the market place.

If your insurance is thru your employer.. abt 50% of large employers are self insured that is referred to as an ERISA prgm – over seen by the Fed Labor Dept and insurance company is just an administrator to pay out your employer’s money for health claims for their employees and their families.  If you have this sort of “insurance” and you get denied…someone at your employer can just call up the insurance company and tell them to pay for your medications as your prescriber wrote for… after all it is your employer’s money that they are paying out.

If you are on Medicare or Medicaid… then you are probably dealing with a Part D Rx prgm… they have a three level appeal process.. they don’t have to tell you about the process unless you ask and then they have to give you the process in writing- today that is probably a website.  Be sure to meet the time limits of making the appeals… expect to get denied the first time because the same system/people that already denied it … is the one handling the appeal.. because a fair percent of pts getting denied will give up… after three denials there is a Administrative Law Judge (ALJ) again they have to tell you the process is writing… the very fact that you KNOW ABOUT the ALJ appeal level… may be enough to get them to cave… because they know that at least 50% get to this level will get approved.  Doesn’t cost the pt anything, and now a days… it is probably a ZOOM type meeting..  the pt doesn’t need an attorney… just needs to state way they need what was denied … it is a pretty straight forward process.

It is also good if the pt calls 800-MEDICARE or www.cms.gov and file a complaint against any provider for denying you care.

Any other kind of health insurance… you just have to ask what their appeal process is and if they don’t offer… ask for the details in writing… the more times you appeal … the more likely the pt will get a YES/APPROVED.

 

 

 

 

 

I reserve the right of editorial censorship

It looks like the political “mud slinging” has already started – IMO – worse than the national election two years ago… I am taking a stand – in particular – against “slanderous name calling”  directed toward specific politicians, particular political parties and/or specific people.  I don’t mind political debate – based on FACTS… when the debate drifts off the road based on FACTOIDS, FAKE NEWS, opinions stated as FACTS.. is where I am going to draw the “line in the sand” and delete comments that go down that path.

While personally, I am not a big fan of our political/bureaucratic system.. IMO.. it is too self serving… Admittedly, politically I tend to lean to the POLITICAL RIGHT but that is because the Libertarian party is seemingly always kept in their place by our dominating “two party system”.

I have belonged to a national pharmacy association for 35 yrs… that promotes the saying “get into politics … or get out of pharmacy ..” If you don’t attempt to influence politicians… someone else will…. and IMO this saying applies to those in the chronic pain community and/or pts who are dealing with subjective diseases.  Legislatures, bureaucrats are doing things that are adversely effecting the quality of life of those pts.  As long as those being affected continue to lack unity and/or a large segment chooses to stand on the sidelines, whoever is successfully “bending the ear” of these politicians … they will continue to do so because they have  little/no concern about the consequences and/or collateral damage that they cause to those suffering and dealing with subjective diseases.

I am sure that the vast majority of my readers will understand and cooperate…those who try to challenge this policy…  It is THREE STRIKES and you are out/banned… and WORDPRESS gives me your IP ADDRESS attached to your comment(s)… Once banned, just posting under a different name – WILL NOT WORK !  Everyone needs to “play nice “

Lastly, please do not post anything promoting a particular vendor or any entity or person selling a product/particular service. Because some may perceive/believe that they have my endorsement which may or may not be the case. Anyone posting a link to a professional selling a product/service will be edited out

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

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.

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.

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

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.”

CMS Proposal to Suppress Hospital Safety Data Angers Advocates

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.

Butler Pharmacy Graduates Earn Highest Pass Rate on the NAPLEX® Licensure Exam

Butler Pharmacy Graduates Earn Highest Pass Rate on the NAPLEX® Licensure Exam

https://stories.butler.edu/butler-pharmacy-graduates-earn-highest-pass-rate-on-the-naplex-licensure-exam/

If student outcomes ultimately define the quality and rigor of a college’s curriculum, as many people assert, then Butler University’s College of Pharmacy and Health Sciences (COPHS) has a claim to being the best of its kind in the nation.

Graduates of Butler University’s prestigious Doctor of Pharmacy (PharmD) program passed the North American Pharmacy Licensure Examination (NAPLEX®) in their first attempt at a higher rate than graduates of any other university in the country. Of the 91 Butler graduates who took the exam for the first time in 2021, 97 percent passed. Of the 144 PharmD programs located in the United States, none had a higher first-time pass rate than Butler University.

“In the face of the pandemic, our faculty and staff remained committed to ensuring that our students received the education they deserved, were able to complete rotations, and stayed on track toward graduation,” Dr. Robert Soltis, Dean of COPHS, said. “Despite site closures and other challenges, every single student in that class graduated on time, and they had the highest pass rate in the nation on the licensure exam. It’s an amazing achievement, and speaks volumes about our commitment and dedication as an institution. I could not be prouder of, or happier for, our faculty and our students.”

According to its website, the NAPLEX® is designed to evaluate general practice knowledge and is taken by recent college of pharmacy graduates shortly after they receive their degree. The NAPLEX® is just one component of the licensure process and is used by the boards of pharmacy to assess a candidate’s competence to practice as a pharmacist. The six-hour exam is composed of 225 questions that are delivered in a computerized, fixed form. The exam results are reported as pass or fail, and candidates are allowed five attempts to pass the exam.

Butler PharmD graduates have a history of scoring well on the NAPLEX®. In each of the past three years, at least 93 percent of Butler graduates passed the exam on their first attempt.

The results come at a critical time; in Indiana and across the nation, there is a significant shortage of pharmacists, especially among the national chains. Some pharmacies have had to reduce hours or even close for one day a week due to reduced staffing. Both CVS and Walgreens have announced they are increasing salaries in hopes of recruiting more pharmacists to their locations.

“Just five years ago, we were talking about a surplus of pharmacists in this country, but the pandemic quickly changed that situation,” Dr. Soltis said. “Now, the increased demand for vaccinations has resulted in increased demand for pharmacists. Graduates of Butler’s pharmacy program are going to find an improving job market and more opportunities to use their skills to serve patients.”

When I decided to attend Butler University and major in pharmacy,  I had been told that NO BUTLER GRAD HAD FAILED TO PASS THE ” Indiana Pharmacy board”  My class was the first year that the  North American Pharmacy Licensure Examination (NAPLEX®) was usedThere was nothing available to prepared for the exam, there was no one to ask what was on the board the previous year…  My Butler class had ONE that didn’t pass the boards, but that year was the first year for the MILITARY DRAFT LOTTERY and this poor fellow drew a very low number and his draft board had been after him to be drafted but the Indiana pharmacy board wasn’t until Sept or Oct after the graduation in May.  Perhaps the stress and distraction of trying to keep the draft from drafting him.  After all, the Vietnam was on going and soon after this time.. it started ramping up.

Yours truly’s lottery number was 360 – SIX FROM THE BOTTOM… since the lottery pool was every male between 18 and 35 y/o… the number of “bodies” in that lottery pool was VERY LARGE.

 

One in Four Medicare Patients Harmed in Hospitals, Nearly Half Preventable

One in Four Medicare Patients Harmed in Hospitals, Nearly Half Preventable

CMS needs to do more to penalize facilities with avoidable adverse events, report says

https://www.medpagetoday.com/special-reports/exclusives/98701

Medicare patients continue to experience harm during hospital stays, even after a decade of intensive efforts to decrease provider-caused adverse events, according to a report from the HHS Office of Inspector General (OIG).

Among the roughly 1 million Medicare patients who were discharged from hospitals in October 2018, a total of 258,323 experienced an adverse or temporary harm event during their stay.

And 12% experienced events that led to longer stays, lifesaving interventions, permanent harm, or death. “This projects to 121,089 Medicare patients having experienced at least one adverse event during the 1-month study period,” the report stated.

Of these adverse events, 45% were said to have been preventable. According to the report, such events were linked to substandard or inadequate care — for example, using more aggressive pain management regimens after surgery than necessary, or unnecessary delays in scheduling surgeries.

In one of many case studies and patient stories included in the report, a patient required surgery to remove dead tissue from the small intestine. “However, providers unnecessarily delayed surgery for 5 days while the patient continued to deteriorate. This delay led to a cascade of harms that included worsening of the small intestine, contamination of the abdomen with pus, septic shock with an associated kidney injury, and delirium,” the report noted.

Ten percent of adverse events contributed to patient deaths, translating to 1.4%, or 14,800 patients, during the 1-month study period.

Leah Binder, president and CEO of the Leapfrog Group, which routinely grades hospitals on various safety measures, called the report’s findings “outrageous.”

“None of us would drive a vehicle or check into a hotel if we thought we had a one in four chance of being harmed from the experience,” she said.

The report also showed that 13% of patients experienced temporary harm, which required intervention but did not prolong their hospital stay or require life-sustaining measures, and over 40% were determined to be preventable. However, such events were sometimes serious and could have caused further harm had providers not noticed and quickly intervened, the OIG said.

Common adverse and temporary harm events included those related to medication use, involving delirium or other mental status changes; pressure ulcers or injuries; complications from procedures or surgeries such as intraoperative hypotension; and hospital-acquired infections (HAIs).

Of particular concern, the OIG found that patient harm events were almost as widespread as they were found to be in 2008 among a similar sample size. Back then, 27% of the patients sampled experienced a harmful event. However, the report noted that the 2018 population had a greater prevalence of comorbidities than the 2008 sample, with more “being treated for more clinically complex conditions and diagnoses than in the past.”

Adverse events result in higher costs for beneficiaries who have to pay more in deductibles and co-payments because of additional care required. The report estimated that for some treated beneficiaries, additional expenses amounted to more than $40,000. “Combined, we estimated the cost for all events to be in the hundreds of millions of dollars for October 2018,” the report stated.

The OIG noted that CMS has two policies designed to deter hospital-acquired conditions (HACs), including cuts in reimbursement to hospitals with higher rates of such conditions. However, “because the policies use narrowly scoped lists of HACs and employ specific criteria for counting harm events, they have limited effectiveness in broadly promoting patient safety,” the report said. “Of the harm events we identified, only 5% were on CMS’s HAC Reduction Program list and only 2% were on CMS’s Deficit Reduction Act HAC list.”

Furthermore, when CMS counts infections associated with a surgical procedure in its formula to penalize hospitals, it counts only those involving the colon or an abdominal hysterectomy, so many other infections go uncounted, such as those occurring after a laminectomy.

Additionally, the report found that hospitals often omit specific codes that CMS uses to monitor the occurrence of HACs, thereby limiting the agency’s awareness of some events in Medicare-certified hospitals.

According to the OIG and Binder, CMS should include more types of harm events in its formula for penalizing hospitals. The current policy shift appears to be steering the agency away from that, Binder noted.

“Though in the report CMS concurred with this recommendation, the agency is moving rapidly in the opposite direction, not growing the number of measures, but removing all the HACs and HAIs from payment consideration. CMS’s Proposed Rule calls for suppressing all HACs and HAIs from use … and replacing them with nothing,” she said.

The report noted that “only the worst 25% of performers receive the 1% reduction each year.” Furthermore, “hospitals that routinely are in the top three quarters of performance do not have a financial incentive through the HACRP [HAC Reduction Program] to improve more.”

Contact Congress to stop FDA & Big Pharma’s attempt to control supplements and get power to ban kratom

Contact Congress to stop FDA & Big Pharma’s attempt to control supplements and get power to ban kratom

The Prescription Drug User Fee Act reauthorization is being used to give the FDA even more power to threaten kratom and all supplements

First off, we understand this is getting into the legislative weeds, but this is incredibly important as it could change how all supplements and kratom are controlled by the FDA. 

The Prescription Drug User Fee Act or PDUFA is up for reauthorization, and proposed changes to it could give the FDA power to deny registration of all supplements; granting them power to require kratom to be registered, and therefore the power to deny registration and effectively ban all kratom products

Please contact your congressional representatives today! Go to Protectkratom.org/congress using the link below to complete the email contact for to tell Congressional officials not to support any attempts to require supplement registration.

Supplements are not prescription drugs, and shouldn’t be treated the same.  

NOTE: The House Committee on Energy & Commerce is meeting on the PDUFA regulation for the House so we’ve created an additional contact form to be used for them as well. 

After years, pharmacy-middleman suit might finally come to trial

 

After years, pharmacy-middleman suit might finally come to trial

https://ohiocapitaljournal.com/2022/05/16/after-years-pharmacy-middleman-suit-might-finally-come-to-trial/

Since at least 2016, Ohio pharmacists have been accusing large companies acting as pharmacy middlemen of abusive practices, which they deny. And since 2019, the state has been accusing them as well, in the form of lawsuits.

Now, after years of wrangling in court, some of that litigation might be headed to trial.

The middlemen, known as pharmacy benefit managers, operate behind the scenes, but they’re part of some of the largest corporations in the United States. And the big three, which handle prescription transactions for more than 70% of covered Americans, are part of companies that also own major insurers.

Pharmacy benefit managers, or PBMs, negotiate rebates from drugmakers, in part by controlling which drugs are covered by insurance and at what level. They contract with networks of pharmacies and decide how much to pay them for the prescriptions they dispense.

In 2016, two of the big-three PBMs — CVS Caremark and OptumRx — were working for Ohio’s five Medicaid managed-care companies. Late that year, many Ohio pharmacists complained, the companies slashed their reimbursements and then CVS — which was also their biggest retail competitor — offered to buy them out.

CVS and OptumRx insist their reimbursements have been fair and that their actions have saved money for consumers and taxpayers. But amid a newspaper investigation and one by then-Auditor Dave Yost, the Ohio Department of Medicaid in 2018 commissioned an investigation that showed that in 2017, CVS and OptumRx charged taxpayers $244 million more for Medicaid drugs than they paid the pharmacies that dispensed them.

While that was a bombshell, big portions of the analysis were redacted. Under prodding from lawmakers and the press, then-Medicaid Director Barbara Sears moved to release an unredacted version. CVS and Optum sued on July 16, 2018 to block release.

That suit continues, even though The Columbus Dispatch was able to get behind the redactions and show that CVS in 2017 reimbursed big competitors such as Kroger and Walmart much worse than it did its own pharmacies.

The case has languished for almost four years, with Franklin County Common Pleas Judge Andy D. Miller most recently granting another delay last month.

But another, perhaps more substantive case, appears to be moving ahead.

After he became attorney general, Yost in 2019 sued OptumRx over its dealings with the Ohio Bureau of Workers’ Compensation. That suit claims that Optum defrauded the agency of $16 million by not providing guaranteed discounts and through other practices.

It’s slated for trial before Franklin County Common Pleas Judge Michael Holbrook on Oct. 24, and the parties seem to be getting ready for trial.

“We are in the discovery process and planning accordingly for our trial date in October,” Yost’s spokesman, Steven Irwin, said in an email on Tuesday.

A spokesman for OptumRx again denied that the company had done anything wrong.

“We are honored to have delivered access to more affordable prescription medications for the Ohio Bureau of Workers’ Compensation and Ohio taxpayers,” the spokesman, Andrew Krejci, said in an email. “We continue to believe these allegations are without merit and will vigorously defend ourselves.”

Yost also has sued another of the big-three PBMs, Express Scripts, on behalf of the Ohio Highway Patrol System. The suit seeks an unspecified dollar amount after Express Scripts “egregiously charged for services it didn’t deliver,” Yost said. 

Express Scripts also denied wrongdoing. The case now is slated for trial before Franklin County Common Pleas Judge Colleen O’Donnell in June 2023.

When he announced the workers’ comp suit, Yost said it was the start of a flurry of litigation against the pharmacy middlemen, and his office is said to be pursuing other claims.

He tallied a big win last year after he sued Medicaid managed-care provider Centene over dealings using its in-house PBMs. Centene didn’t admit wrongdoing, but it agreed to pay Ohio $88.3 million and set aside an additional $1 billion to settle similar claims in states that hadn’t even sued.

 

Medicare Advantage Versus Traditional Medicare

Medicare Advantage Versus Traditional Medicare

https://www.daily-remedy.com/medicare-advantage-versus-traditional-medicare/

Financial engineering is a derisive term given to private equity firms who spruce up the value of their portfolio companies by manipulating cash flow statements on Excel spreadsheets.

Technically, the company is performing at the same level as before, but on paper it looks much better.

In healthcare, we find a similar phenomenon, called clinical engineering. By manipulating the documentation and reimbursement coding, healthcare systems can appear to provide greater value to their patients than what they really offered.

We find this among health systems that offer Medicare Advantage plans, the latest rendition of health management organizations (HMOs) and preferred provider organizations (PPOs). They use different payment mechanisms to receive financial remuneration for clinical services rendered, instead of the traditional fee-for-service model, where a set amount is given for a specific clinical service. These health systems incorporate a far more complicated financial scheme.

Centers for Medicare and Medicaid Services (CMS) rates Medicare Advantage plans based on over 40 quality measures. These measures are then benchmarked against other similar health plans across the nation. Reimbursement becomes a complex mix of base compensation and premium reimbursements, which often have less to do with clinical care and more with financial incentives.

Most patients are not aware of the payment differences. To them, it is all the same, because the premiums paid by members of Medicare Advantage and traditional Medicare plans remain roughly the same. But the reality is these two payment models could not be further apart – and with different financial structures come different financial incentives.

The Office of Inspector General (OIG) acknowledges as much, and in a scathing report last Fall took many Medicare Advantage plans to task, particularly the United Healthcare plans, citing overly aggressive documentation practices as the primary driver of clinical value, more than any true clinical improvements in patient care.

The Commonwealth Fund confronts this uncomfortable notion at face value and evaluates the clinical value gleaned from Medicare Advantage plans compared with traditional plans.

It discloses every moral hazard and exploitable opportunity available in Medicare Advantage plans as they are currently structured. It details the very mechanisms of clinical engineering so many Medicare Advantage plans have enjoyed for nearly half a decade.

It concludes by demonstrating little to no true clinical value gained in Medicare Advantage plans relative to traditional Medicare plans. The implications prompt an awkward question we should all be asking: Should we have less regulation and oversight in healthcare?

Medicare Advantage plans were touted as the latest and greatest attempt to improve the almighty behemoth that is healthcare. Yet it is susceptible to the same failures as all other prior so-called-saviors in healthcare. The recurring failed attempts show an undeniable fact: When clinical value depends on the quality of documentation, it ceases to be an appropriate metric for quality of care.

This presents an interesting paradigm, known as Goodhart’s Law: “When a measure becomes a target, it ceases to be a good measure”. When clinical documentation becomes the primary driver to measure quality in healthcare, the documentation becomes a poor marker of quality.

This is a uniquely challenging quagmire for regulators. The federal government has created a system of oversight ostensibly reliant on documentation. But if the very metric to regulate healthcare becomes a poor marker of quality of care, then regulators must question their very basis of oversight.

We assume clinical data is good and we reward Medicare Advantage plans for maintaining good clinical records. But the value of data quickly deteriorates when it becomes nothing more than the tool which health plans use to manipulate clinical outcomes.

In the ever litigious culture of healthcare, we gravitate toward the quantitative. We value what we can measure. And we regulate whatever can be measured. But eventually, what we measure ceases to be a good metric of what we are targeting. And for Medicare Advantage plans, it seems we are at this point, particularly where every measurable metric provides some form of reimbursement.

Perhaps we should focus less on measuring the seemingly endless array of metrics, and relieve health systems of the burden of measuring metrics as a whole.

We may find something more valuable than a metric to measure: We may find the implicit motivation to improve patient care.

 

Walgreens reaches opioid settlement with State of Florida

It appears that in FLORIDA Walgreens is being sued for “contributing” our fabricated opiate crisis and in CALF they are being sued for having their stores understaffed and putting pt’s safety at risk from mistakes Walgreens’ Priority Was Filling Drug Orders Fast, Judge Told

https://www.tobaccofreekids.org/assets/factsheets/0365.pdf     Florida got 10+billion out of the Tobacco settlement at the end of the last century. I don’t know if they were hoping to extend the “annual annuity payments” from the tobacco settlement with suing the pharma industry.  It appears that this settlement comes up short.

Florida may be returning to the pharmacy environment back in the mid 2010-2020 decade… when most chain pharmacists were SELDOM COMFORTABLE filling Rxs for controlled meds… the term was coined back then as the “Pharmacy Crawl”..where pts trying to get a controlled Rx filled may have to go to a dozen or so different pharmacies in trying to get a controlled Rx filled.  Can you imagine a chronic pain pts … having to drive around most of a day to find a pharmacy to fill their pain med Rx ?  Back then controlled Rxs were still “paper”, so the pt had a Rx in their hand. Today, most all controls are now sent to a pharmacy electronically. When a pharmacy/pharmacist can’t/won’t fill a C-II,  the Rx basically goes dead, because the pharmacy can’t do nothing but CANCEL the electronic Rx… and the pt is having to have to reach out to their prescriber to send it to another pharmacy. Of course, pharmacies will not tell a pt over the phone if they actually have a particular C-II in stock. When one of the early statements in the early part of the war on drugs was “JUST SAY NO”… may take on a new meaning for chronic pain pts trying to get their pain meds filled .

Walgreens reaches opioid settlement with State of Florida

DEERFIELD, Ill. — Walgreens announced Thursday that it has entered into an agreement with the State of Florida to resolve all claims related to the distribution and dispensing of prescription opioid medications across the company’s pharmacies in the state.

The settlement amount of $683 million includes $620 million to be paid out to the State of Florida over 18 years, as well as a one-time payment of $63 million for attorneys’ fees.

The settlement includes no admission of wrongdoing or liability by Walgreens.

“As the largest pharmacy chain in the state, we remain focused on and committed to being part of the solution, and believe this resolution is in the best interest of all parties involved and the communities we serve across Florida,” said Danielle Gray, executive vice president and global chief legal officer, Walgreens Boots Alliance. “Our pharmacists are dedicated health care professionals who live and work in the communities they serve, and play a critical role in providing education and resources to help combat opioid misuse and abuse.”

As one of Florida’s leading health care providers, Walgreens has taken a number of actions to prevent and respond to the opioid crisis, while continuing to serve patients, including:

  • Providing patient education on safe opioid use
  • Making life-saving Naloxone, the opioid overdose reversal medication, available in all Walgreens pharmacies nationwide
  • Providing safe and convenient medication disposal kiosks available at 1,400 Walgreens stores, along with other safe disposal options at all other Walgreens locations
  • Deploying technology to help pharmacists ensure they are dispensing prescriptions written for a legitimate medical purpose
  • Stopping self-distribution of opioids and all pharmaceuticals to Walgreens stores in 2014

The settlement funds will be used by the State of Florida to support its efforts to combat and treat opioid addiction. The settlement is a result of unique facts and circumstances concerning the state of Florida. It should not be used to forecast or predict the value of any other litigation claims or future settlements, and is unrelated to any other opioid-related litigation in which Walgreens is involved and which the company will continue to defend vigorously.

Click to access 0365.pdf

Walgreens’ Priority Was Filling Drug Orders Fast, Judge Told

Walgreens’ Priority Was Filling Drug Orders Fast, Judge Told

A former Walgreens pharmacist felt pressured to “fill, fill, fill” prescriptions while working at a pace that made her fear making fatal errors, a California federal judge heard in recorded testimony Thursday in a multibillion-dollar bellwether trial over claims Walgreens and others illegally fueled San Francisco’s opioid epidemic.

The city of San Francisco has accused Walgreens, along with drugmakers Teva and Allergan and drug distributor Anda, of creating a public nuisance by marketing opioids with misleading messages about their safety and failing to prevent the ensuing flood of painkillers from being diverted for improper uses.

Thursday marked the second day of the bench trial in which the testimony focused on San Francisco’s case against the pharmacy chain. It included the recorded deposition of Rebecca Gayle, who worked at a San Francisco Walgreens as a staff pharmacist from 2012 to 2016, also holding the role of assistant store manager from 2014 to 2016.

“The most challenging part of working at Walgreens was I constantly felt there was the pressure to fill, fill, fill, and that was what the company cared about most,” Gayle said. “That’s the message I got.”

The demand to fill prescriptions quickly made it difficult for her to investigate suspicious prescriptions or talk to patients about their medications.

“I constantly got feedback to go faster, shave down on the things that were most important to me as a pharmacist like counseling patients,” Gayle said, later adding, “I ran into situations where I was afraid I made a lot of mistakes that could result in severe patient … harm or even death, depending on medication and the type of error.”

During Gayle’s cross-examination, a lawyer for Walgreens asked her if she believed she and her colleagues were doing their best on behalf of their patients and to make sure they prevented diversion.

“I feel like we, as pharmacists, could have had many more tools, and support from a staffing and time perspective, to do more due diligence to prevent diversion,” Gayle said. “We were doing our best, but it was limited given the volume of prescriptions we were filling and the pace at which we were expected to fill.”

Gayle said she would sometimes search doctors’ names on the internet if she felt something was fishy about them, as well as leave notes for her colleagues to warn them about doctors who appeared to be issuing excessive opioid orders.

If there was a strong red flag, Gayle said she and her colleagues would sometimes refuse to fill a prescription.

Brian Swanson of Bartlit Beck Herman Palenchar & Scott LLP, an attorney for Walgreen’s, asked Gayle if she was ever punished for refusing an order, and she said no.

Among doctors who had “fishy” prescribing practices was Collin Leong, Gayle said. He ultimately lost his license in 2013 and pled guilty to selling opioid prescriptions to homeless people with no medical justification, but not before Walgreens filled thousands of his prescriptions, according to a document the city filed with the court. 

An attorney for San Francisco showed Gayle a news article that said the homeless people would be given cash for the pills from a third party. Leong charged $80 to $150 for a prescription, taking in about $400,000, according to the news report.

“Did your district managers ever ask you to identify suspicious prescribers so they could warn others?” the attorney asked. Gayle said no.

Another former San Francisco Walgreens employee, Victor Lo, also testified that the store he worked at was inadequately staffed, making it difficult to do his job carefully.

“We always felt like we were behind, we always felt, at least I felt, I could potentially dispense something incorrectly,” Lo said.

Lo, however, testified that when he told his supervisor that he felt the pharmacy was dispensing a lot of narcotics from doctors who appeared to be “too free” in writing prescriptions, he was told the pharmacists couldn’t say no.

“We couldn’t categorically say flat out we’re not filling these prescriptions from a licensed prescriber. Those prescribers could sue Walgreens,” Lo said he was told.

In addition to Lo, live testimony was given Thursday from Carmen Catizone, who said Walgreens did not meet the standard of care legally required of pharmacies. Among concerns, from 2003 to 2012, Walgreens had a policy passed on to pharmacists to merely call the doctor who issued a questionable prescription as opposed to doing any other due diligence.

“This is especially true when the prescriber may be assisting the patient to inappropriately use controlled substances,” Catizone said.

In 2013, Walgreens introduced a checklist for pharmacists to use when dispensing some drugs, but it didn’t cover some commonly diverted opioids. Until 2020 the checklists were maintained only in hard copy at each pharmacy, and not electronically, so they could be shared with other stores, Catizone said.

During cross-examination, Swanson took aim at the list of “red flags” or warning signs that suggest opioid abuse or diversion that Catizone said pharmacists are required to be on the lookout for.

“You don’t cite any federal or state statute that discloses each of these specific red flags you identify, do you?” Swanson asked, later noting that they also don’t appear in the Controlled Substances Act.

Swanson also posed several hypothetical situations to Catizone that would result in a legitimate prescription being flagged. For example, if a patient obtained multiple opioid prescriptions from different prescribers.

“That would flag a patient who broke a leg and then gets an opioid script from the ER and then gets a second prescription from the orthopedist who treats them,” Swanson noted.

Walgreens’ lawyer also said pill volume wasn’t necessarily a red flag, for example, if a doctor was prescribing for an oncology patient or for pain management.

Catizone’s time on the stand was about 30 minutes, in keeping with Judge Breyer’s orders and a tight trial timetable, limiting direct witness examinations to written declarations with only a short live introductory summary.

Catizone, who served as the executive director and CEO of the National Association of Boards of Pharmacy from 1988 to 2020, also submitted a 35-page declaration to the court.

The Bay Area litigation is the first to rope together defendants across the pharmaceutical supply chain, from manufacturing to distribution and pharmacy dispensing.

San Francisco is represented by its city attorney’s office, Lieff Cabraser Heimann & Bernstein LLPRobbins Geller Rudman & Dowd LLPAndrus Anderson LLPWeitz & Luxenberg PCSimmons Hanly Conroy LLC and Levin Papantonio Rafferty.

Allergan and its affiliates are represented by Kirkland & Ellis LLP.

Teva and its affiliates are represented by Morgan Lewis & Bockius LLP.

Anda is represented by Foley & Lardner LLP.

Walgreens is represented by Bartlit Beck LLP and Gibson Dunn & Crutcher LLP.

The case is City and County of San Francisco et al. v. Purdue Pharma LP et al., case number 3:18-cv-07591, in the U.S. District Court for the Northern District of California. The MDL is In re: National Prescription Opiate Litigation, case number 1:17-md-02804, in the U.S. District Court for the Northern District of Ohio.

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