Sep
3

Will the FDA keep your family safe?

Would you let your kids/parents/grandparents be injected with a COVID19 vaccine “approved” by the FDA?

The same FDA that lied about treating COVID with blood plasma and hydroxychloroquine?

How about the blood plasma scam? FDA chief Stephen Hahn flat out lied in public, claiming it “saved” 35% of COVID patients. Now the NIH has weighed in, refuting Hahn’s lies.

Now Trump et al want the FDA to issue an Emergency Use Authorization for a vaccine – something that has NEVER been done before, because it is incredibly dangerous.

Remember hydroxychloroquine? Touted as a miracle drug by the President, his Administration and allies, we know it is far more dangerous than helpful. And we knew that when the FDA gave it conditional use approval (that was later revoked).

Fox News on the FDA’s screw up…

Both were touted as solutions to COVID19 – and both claims were proven to be flat out wrong.

Now we have that same FDA telling states to prepare for a vaccine that will be ready in early November. The Centers for Disease Control is also involved.

The Administration is turning the FDA – once the world’s leading scientific authority on drug approval, research, and guidance – into a political machine. Lesser known is that the FDA’s oversight of pharma and food safety has plummeted under Trump.

Without full vetting of a vaccine, we do not know if it will hurt us more than help.

If this was happening under a Hilary Clinton administration I’d be screaming bloody murder.

What does this mean for you?

Elections have consequences. 

 

 


Aug
28

Another whirlwind week is just about over, and with it the summer of 2020.

Here’s important/interesting news that came across my virtual desktop this week.

COVID and Comp

More data on workers’ comp COVID19 claims is coming in; Virginia’s Workers’ Comp Commission has published data; key takeaway is to date, only 8.3% of COVID19 claims reported have resulted in benefit payments. That will certainly increase as claims develop.

More info on state COVID reporting is here – you can watch a recorded webinar on the subject here – Mark Priven and I dive into data from California and Florida and discuss the implications thereof.

Meanwhile, employment took another hit as last week more than a million Americans filed for unemployment. This continues a five-month run of claims at or above the million mark. 14 million of us are still without jobs.

COVID19’s impact on health insurance coverage

Several million people have lost their health insurance due to COVID19-related job losses.  We don’t know the specific number – and it is certainly increasing – but it is likely between 3 and 12 million. (download the report for details).

Another perspective is here.

Most of those folks are lower-income workers and many are minorities; some may be eligible for Medicaid however states that did NOT expand Medicaid such as Texas and Florida will see an increase in uninsured care costs.

Congratulations to myMatrixx and new Chief Sales Officer David Dubrof; David is one of the very few “A” players in work comp services sales; myMatrixx will benefit greatly from his sales leadership. David and his colleagues are equally fortunate; payers have consistently rated myMatrixx the top workers’ comp PBM. (myMatrixx is a client)

NCCI published a report on the impact of fee schedule changes on outpatient facility costs.  Good to see this rapidly-rising cost driver getting attention.

Implications

  1. Fewer jobs = lower payroll = lower work comp premiums
  2. Things are tough and getting tougher for lower-wage workers, which are disproportionally people of color.
  3. More uninsured = more need for facilities to get $$ from those who are insured.

Aug
26

BWC’s dividends and drug costs

Last week Ohio’s Bureau of Workers’ Compensation announced it will consider $1.5 billion in dividends to policyholders.

This comes on the heels of a similar payout in April;

$1.35 billion went to private employers and $184 million went to local government taxing districts, such as counties, cities, townships, and school districts.

Together, the two dividend payments amount to a refund of all premiums paid by employers in 2018 and 2019.

The Bureau’s very strong financial results were attributed to excellent investment performance, a continued decline in claim counts, and “prudent fiscal management.”

A significant piece of this “prudent fiscal management” was the audit of BWC’s pharmacy program, an audit that led to the State Attorney General suing BWC’s PBM OptumRx. Subsequently AG Dave Yost accused OptumRx of overcharging “the state on 57% of 2.3 million claims between January 2014 and September 2018.” [it is important to note that BWC’s prior PBM was acquired by Optum and operated under a separate business unit]

The suit was later amended to reflect Yost’s allegation that overcharges exceeded $16 million.

BWC switched PBMs two years ago.

BWC’s drug costs have dropped significantly over the last couple of years; while a decline in claim frequency undoubtedly contributed to that drop, it is safe to say that prices paid for drugs helped slash pharmacy expenses.

And that has helped fund the huge dividend checks BWC’s customers are getting.

What does this mean for you?

Do you know you are paying only what you should? 

How can you prove that to your policyholders and customers?


Aug
25

Lies, Damn lies, and Statistics – the Blood Plasma debacle

Sunday President Trump, HHS Secretary Alex Azar and FDA Commissioner Dr Stephen Hahn said the use of blood plasma had reduced COVID19 deaths by 35%.

Trump said it was a “tremendous” number.

Azar said:

“We saw about a 35 percent better survival in the patients who benefited most from the treatment, which were patients under 80 who were not on artificial respiration…I don’t want you to gloss over this number…We dream in drug development of something like a 35% mortality reduction. This is a major advance in the treatment of patients.”

Hahn said

“a 35 percent improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — 100 people who are sick with covid-19, 35 would have been saved because of the administration of plasma.”

This is not “stretching the truth”, or over-generalizing, or taking something out of context.  It is total bullshit.

A REAL FDA scientist – whose name was redacted from an FDA memo, was a LOT less enthusiastic, writing the study data:

 “support the conclusion that [convalescent plasma] to treat hospitalized patients with COVID-19 meets the ‘may be effective’ criteria for issuance of an EUA. [emphasis added; EUA = emergency use authorization, which allows use of a treatment before it goes thru the entire approval process]

There is no basis or source for the 35% figure; it appears to have been derived from a very small group of patients treated at the Mayo Clinic.

Note the emphasis on “appears”; that statistic was NOT in the Mayo Clinic’s 31 page report;

  • nor was it in a memo authored by FDA scientists,
  • nor was it in the FDA’s letter authorizing use of blood plasma on an emergency basis to treat COVID19,
  • Nor could it have been credibly derived from the actual study report.
  • Nor did one of the principal study authors have any idea where the 35% figure came from.

If anything, it looks like Azar, Hahn, and President Trump cherry-picked data by only looking at results from a very select and very small subset of a subset of patients; those:

  • less than 80 years old;
  • not on a ventilator; that
  • received plasma within 3 days of diagnosis, and
  • received plasma with high levels of antibodies.

But wait, you say, that’s still good news!

Okay,

Here’s what the study actually found as reported by the NYTimes:

among the larger group of more than 35,000 patients, when plasma was given within three day of diagnosis, the death rate was about 22 percent, compared with 27 percent when it was given four or more days after diagnosis.

Hahn later corrected his statement – but only after an official FDA spokesperson perpetuated the fraud…

I get we all want to find a cure, and a vaccine, and we want this long global nightmare to end. We want the dying to stop, the suffering to end, the pain to go away, life to return. But our only hope is rigorous, robust, careful and thorough science.

Not political grandstanding, not abuse of a vitally important Federal Agency, not outright lying. We’ve been down this path before, and it didn’t turn out well.  Remember hydroxychloroquine?

Does it appear blood plasma from patients that have recovered from COVID19 may be beneficial? Yes. Is it likely it will help some patients? Well, there’s some evidence it may help some patients.

Is it a universal cure?

Highly unlikely.

What does this mean for you?

Science matters. Dig deep, ask hard questions, and don’t believe the headlines until you do your homework.

 


Jul
24

Friday catch-up

COVID and client work has kept me way too busy this week – hope to be back to more frequent posting soon. Meanwhile, here’s what I missed…

Workers’ comp drug trends

myMatrixx released its annual Drug Trends Report. Key findings include:

  • 6.1% drop in drug spend for myMatrixx clients
  • 10.7% drop in opioid spend
  • over five years, clients’ opioid spend dropped 45%
  • Lyrica’s brand patent expired; within 4 weeks over 90% of patients had been switched to a less-costly generic

(myMatrixx is an HSA consulting client)

Workers’ comp pharmacy regulations – WCRI’s national inventory

Is available for purchase here. This is a must-have for any and all workers’ comp payers. Info on medical marijuana, opioid prescribing limits, drug testing, and pricing is all there.

Presumption

Pretty solid summary of presumption changes provided by the Premium Reduction blog; some good reporting on numbers of claims in FL, CO and CA as well.

Medical pricing lookup

Medata has a pretty cool medical service pricing lookup tool that’s useful for consumers, adjusters, and employers. It includes pricing for group health, auto, and workers’ comp.

COVID’s impact

Thanks to Risk & Insurance’s Courtney DuChene for her reporting on our survey of COVID”s impact on workers’ comp.

Finally, this…

And, one day, perhaps this…


Jul
9

myMatrixx released it’s annual Drug Trend Report yesterday; there’s a lot of good news – and a few trends that bear close attention.

The good stuff (lots more in the report itself)

  • drug costs per patient decreased by 2.4% despite a 1.9% increase in utilization
  • opioid cost per patient continued to drop, this time by 10.7%
  • comparing claims incurred in 2019 to those incurred in 2016 or earlier:
    • 45% fewer patients were prescribed opioids
    • the average days supply dropped by 2/3rds, from 28 to 9
    • the average morphine equivalent dose dropped by 40%

Stuff that demands your attention.

Many payers are working hard to close older claims. For claims older than about 8 years, pharmacy costs account for almost half of medical expenses. Obviously, ensuring the drugs prescribed and dispensed to long-term patients are still appropriate and are helping the patient recover is the first step in developing a plan to resolve these old – and very expensive – claims.

Specialty meds are becoming increasingly common – and increasingly costly, accounting for 8.8% of drug costs.

The bad stuff

Physician dispensers are the worst. They suck money out of employers and taxpayers, justifying their rampant profiteering by lying about maintaining patient access and improving care. 

Their latest scam is topicals. One out of every eight physician dispensed meds is a topical, but one out of every three dollars you pay for physician dispensed drugs is for a topical.

chart used by permission

One – methyl salicylate cream 25% – is available at retail pharmacies for about five bucks. Physician dispensers are getting $345.

I’ll save you the math – you are paying 69 times more than you should.

There’s a lot more detail in myMatrixx’ report – you can download it here.

What does this mean for you?

While payers and PBMs have made remarkable progress addressing opioids and controlling costs, much remains to be done:

  • keep the focus on long-term opioid patients
  • aggressively attack physician dispensing
  • if you don’t have a specialty med program, you’d best get one set up.(myMatrixx is an HSA consulting client)

Jun
4

COVID and pharmacy benefit management – an update

COVID19 is having an impact on work comp payers’ pharmacy programs – but this isn’t due to treatments for the disease itself.

That’s largely because there are no medications that have been shown to be safe and effective in treating COVID19 in credible clinical trials.  As a result, there’s little consistency in how payers are approaching medications intended to treat COVID and the symptoms thereof.

Some are approving hydroxychloroquine without a prior authorization (PA) while others require a PA for initial and refills. As the surveys were completed before the latest news that hydroxychloroquine research found less-than-promising clinical results for patients exposed to the virus, it is possible more payers will require at least a PA for future prescriptions. (Other research that reported specific health risks recently came under fire from multiple sources.)

None of the respondents mentioned remdesivir, a brand antiviral that has shown some promise (based on limited clinical trials). This may well change if and when additional trials are completed and the results are satisfactory.

What is consistent is payers’ moves to loosen other prior auth requirements to allow refills for other medications for longer periods and earlier than usual.

Home delivery has also ramped up appreciably, with many retail outlets offering delivery in an effort to keep customers tied to their local store as opposed to using the PBM’s mail order pharmacy.

What does this mean for you?

Unfortunately, we don’t yet have any medications that have been proven to be safe and effective in preventing COVID19 or moderating COVID19’s effects.

Read studies carefully, and get your clinical experts to weigh in on coverage decisions. Science matters.


May
12

Now, about those drug rebates…

Drug rebate dollars account for a big chunk of brand drug costs – more than 40% in some cases. While list prices for brand drugs have been rising rapidly, net prices – the prices actually paid to the manufacturer – have not.

That’s mostly because manufacturers have been paying rebates to employers, insurers, and others in the drug distribution system.

This from Adam Fein PhD of Drug Channels:

A drug’s net price equals the actual revenues that a manufacturer earns from a drug. The net price equals the list price minus rebates as well as such other reductions as distribution fees, product returns, chargeback discounts to hospitals, price reductions from the 340B Drug Pricing Program, and other purchase discounts.

AARP is one of those making bank off rebates, along with lots of healthplans and insurers.

Workers’ comp

The picture’s a bit different in workers’ comp, for several reasons. Rebate payments tend to be lower because:

  • fewer brand drugs are dispensed to work comp patients
  • far fewer speciality drugs – the really expensive ones – are dispensed to work comp patients
  • the brand drugs dispensed to work comp patients typically don’t have big rebates.

But – there’s always a but – rebates must be considered when evaluating your drug spend. If you are an insurer or self-insured employer, a few things to consider:

  • ask your PBM how rebate payments affect your current pricing, and how.
  • if you’re pricing a new PBM, ask if you’re going to get the rebates paid directly to you, or if rebates are included in a calculation of your drug price
  • find out if you are getting ALL the rebate payments, or other entities in the supply chain are getting a cut. [that’s not necessarily a bad thing, but you do want to know where your dollars are going – because they are your dollars]
    • the big PBMs have more buying power, so you’re more likely to get more of the rebate dollars if you’re working with one of the big players

What does this mean for you?

These are your dollars. You need to ask the hard questions to be sure you’re getting the right answers. 


May
8

COVID19 catch up

Three key takeaways from this week’s COVID19 news.

Do we KNOW how bad things are, who’s dying, and Remdesivir.

  1.  Do we know how many are infected, the death rate, and the number hospitalized/in the ICU/on ventilators?

No.

We are three plus months into the crisis and if anything, the picture is muddier than it was a month ago. From the highly-credible COVID Tracking Project;

it is impossible to assemble anything resembling the real statistics for hospitalizations, ICU admissions, or ventilator usage across the United States.

Also from the Project:

the CDC does offer a national-level account of “specimens tested,” this data is incomplete and lagging, and it uses a different unit (specimens tested) for total tests than for positive results (which are counted in people). This makes it impossible to accurately match testing totals with positive tests to infer a complete picture of COVID-19 testing, even at the national level…a simple count of identified COVID-19 cases doesn’t show the true location or comparative severity of outbreaks. Simple case counts show where people are being tested, not where people are sick. [emphasis added]

Yep, the greatest country on Earth can’t even capture and accurately report infections, hospitalizations, and deaths…you should be pounding your head against the wall.

Or maybe just scream in frustration…

2. Who’s dying.

In the New York City, it’s mostly older folks.

From Statista…

Alas, our nation’s leaders still do NOT KNOW how many of our loved ones in nursing homes have been killed by COVID19. 

Almost three weeks after CMS Administrator Seema Verna took to the podium to announce HHS would begin publishing the numbers, we’ve seen nothing.

3. Finally, Remdesivir is NOT a cure – far from it.

The results of a study conducted by NIAID on about 1,000 patients found it does shorten the course of COVID19 – by four (4) days – in some patients. Manufacturer Gilead hasn’t said what remdesivir will cost, but indications are about $4,000 per patient.

NIAID’s study found the anti-viral drug:

  • has been shown to be safe in humans,
  • is given intravenously (it is injected into the blood stream),
  • the course of treatment is 5 – 10 days,
  • has to be administered in a hospital, and
  • the vast majority of patients who recover at home will NOT get the drug.

Perhaps the most important impact will be shortening the course of COVID19 (although that didn’t happen in all patients who got the drug). This will free up more bed-days in facilities and allow them to treat more patients.

Note an earlier study in China did not find remdesivir was effective in treating COVID19. From the study: “Remdesivir use was not associated with a difference in time to clinical improvement”

Lastly, who will actually get the drug depends on luck – some hospitals will get it, others will not, with no rhyme or reason.

For my work comp readers, over at Workers’ Comp Insider Tom Lynch has a quick summary of COVID19 and its impact on workers’ comp.

What does this mean for you?

We should expect way more from our elected officials. 


May
4

RIMS, opioids, and awards to drug distributors’ risk managers

Last month RIMS announced its annual awards; one of the recipients is the risk manager for Cardinal Health, another has a similar role at McKesson.

Awarding awards for excellence in risk management to two individuals at companies with huge liabilities for the opioid crisis, and failing to discuss that liability in press releases is pretty shocking.

Both companies are embroiled in ongoing and likely very expensive litigation regarding their responsibility for the opioid crisis. Cardinal just announced a $4.9 billion loss for the first quarter of 2020, attributing the hit entirely to opioid litigation (the company estimated the cost of litigation at $5.6 billion.

West Virginia is one of the states devastated by rampant overuse of opioids; Pulitzer Prize-winning reporter Eric Eyre just published a book detailing his investigation into Cardinal’s role in the opioid crisis.

According to Eyre, Cardinal “saturated the state with hydrocodone and oxycodone — a combined 240 million pills between 2007 and 2012. That amounted to 130 pain pills for every resident.” All told, distributors shipped 780 million pills into West Virginia over that time.

Cardinal, McKesson, and Amerisource Bergen are the largest drug wholesalers in the nation, acting as the middlemen between manufacturers and retail and mail order pharmacies. While all three contend they are just part of the supply chain, they are required to monitor and report shipments of controlled substances – including opioids, a responsibility that is at the center of the litigation.

(This is not to say the three distributors bear all the responsibility for the crisis – far from it. State health officials, the DEA, FDA, prescribing physicians, opioid manufacturers and others all share in that responsibility.)

From the Washington Post:

McKesson, Cardinal Health and AmerisourceBergen, were in and out of court. They paid lots of fines but kept on trucking. In 2018, their chief executives gave sworn testimony before the House of Representatives Committee on Energy and Commerce: All denied contributing to the opioid crisis. Later that year, the committee released the results of an 18-month study. It found that distributors failed to conduct proper oversight of pharmacies by not questioning suspicious activity and not properly monitoring the quantity of painkillers shipped. [emphasis added]

Earlier this year, McKesson agreed to pay investors $175 million to settle claims that “directors failed to maintain adequate internal systems for spotting suspicious opioid shipments…”  According to Bloomberg, U.S. District Judge Claudia Wilken in Oakland, California said the suit raised:

“legitimate questions about whether directors ignored “multiple red flags” about opioid shipments even after agreeing to step up compliance oversight as a result of a deal with the government.

The settlement, produced in part by a series of mediation sessions, calls for McKesson to add two new independent directors to its board, to beef up compliance training for directors and improvements in internal systems designed to red-flag suspicious orders, according to court filings.”

McKesson is the also the subject of a criminal probe launched by Federal prosecutors in Brooklyn, NY. 

So, the world’s leading risk management organization conferred prestigious awards on risk management professionals at two companies that have massive financial liability – and I would argue ethical responsibility – for what can only be described as a massive risk management failure. And one is the subject of a Federal criminal probe.

I contacted RIMS to inquire about the decision criteria used by the individuals to select the award recipients, stating:

I’m curious as to the decision criteria employed by the award committee that resulted in awards to these two executives. While their accomplishments are impressive and their achievements notable, I’d like to understand how the opioid settlement issue factored into the award decision.

RIMS Communications Director Josh Salter was kind enough to provide an initial response:

RIMS awards are reviewed and selected by volunteers. This group of risk professionals is charged with vetting all submissions and then, using their experience in the profession, making a decision based on the applicant’s accomplishments. While the volunteer group changes from year to year, I will share this information with them.

I asked Mr Salter if he would facilitate a discussion with any members of the committee and offered to keep the names of those members confidential; to date and after multiple requests I have not received a response. [I’m certainly willing to hear from Mr Salter and committee members]

Eyre’s editor, Ned Chilton, coined the term “sustained outrage” to define what he saw as an essential responsibility of news organizations, a demand that media keep the focus on injustices instead of reporting on a calamity and moving on. I’ve been reporting on the opioid crisis since 2005; over the last two years my passion and drive has burned out.

That’s my fault.

I struggle to understand how RIMS could confer prestigious awards for “risk management” on individuals at two huge companies that bear significant responsibility for the opioid crisis – and not even mention the opioid issue in publicity around the awards. This is not to impugn the professionalism, ethics, or abilities of the individuals recognized by RIMS, rather to ask a very uncomfortable question, one RIMS needs to address.

What does this mean for you?

We cannot let crisis fatigue take our focus off opioids.

[PS – kudos to Tristar’s Mary Ann Lubeskie for her ongoing and tireless efforts to keep opioids front and center… you can follow her at @maryannlubeskie on Twitter]