Category: Pharmacy, PBMs, and Pharma costs

Mar
2

The CDC’s Opioids for Chronic Pain Guidelines; Myths and facts

Posted by Joe Paduda on Tuesday, March 2nd, 2021 | Comments

After my posts last week it is clear there’s a lot of misinformation and misunderstanding about the CDC’s opioid and chronic pain guidelines. At MCM we take the old-school approach to these things; we focus on the facts.

So, here they are.

The CDC’s guidelines mandate strict limits on dosage and require tapering  for patients on long-term opioids.

False.  As Dr Beth Darnall of Stanford University noted recently;

some health care organizations and states have wrongly cited the 2016 CDC Guideline as a basis to substantiate prescribing “dose-based limits” or to mandate that physicians and prescribers taper patients taking long-term opioids to specific thresholds (eg, < 90 mg, or < 50 mg). Such dose-based opioid prescribing policies are neither supported by the CDC, nor do they account for the medical circumstances of the individual patient. [emphasis added]

Further;

The CDC [issued] a clarifying statement that derided the misapplication of the opioid guideline and discouraged the dose-based policies and practices that fall outside of its scope, as well as use of the guideline to substantiate tapering.

The Guidelines for Prescribing Opioids for Chronic Pain were developed in secret.

False.  The process fully complied with CDC and AHRQ requirements and standards, and the results were shared with the public and public comment sought prior to promulgation of the final guidelines in 2016.

The Guidelines aren’t working; look at all the opioid-related deaths.

False.

  1. The big increase in drug poisonings (technical term for overdosing) is driven by a rapid increase in the use of synthetic opioids, both prescription and non-prescription. The synthetic opioid death rate increased over 1000% from 2013 to 2019, with the biggest increase in the western US. Fentanyl and Tramadol are examples of synthetic opioids
  2.  There’s been a small but measurable decrease in the death rate (4.4 to 4.2) from prescription opioids that correlates with the guidelines’ publication date.  Of course, correlation is not causation, but clearly the guidelines have been impactful.

3.  Further, when you count the deaths due solely to prescription opioids, the drop in the prescription opioid death rate is even more remarkable. The bold line is prescription opioid-only; the guidelines were introduced in 2016.

The net is those who claim the guidelines are somehow “failing” are conflating law enforcement issues with public health issues, and are ignoring the very real post-guideline decline in deaths from prescription opioids.

The guidelines are killing people.

The guidelines are just that – guidelines.

The guidelines do NOT require or mandate dosage restrictions or tapering. Blaming the guidelines – and those who developed the guidelines – for physicians not following the guideline’s explicit recommendations is wrong, and does nothing to solve the problem of bad legislation and poor physician behavior.

Here’s what the CDC actually said:

Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids. [emphasis added]

There are a lot of anecdotal reports of patients unable to get prescriptions renewed or otherwise forced off their opioid regimen, many with awful consequences. Yes, the guidelines did suggest/encourage/support these tools in certain circumstances, but – as you can read above – these are NOT requirements and require clinicians to evaluate and balance risk and harm.

What does this mean for you?

The real problem with Opioid Guidelines is states, insurers, and other entities – as well as prescribing physicians – failing to use the guidelines as intended.

reminder to commenters – valid email addresses are required, and disagreements are welcome as long as they are supported with credible citations.

 

Feb
22

The scammers fighting CDC’s opioid guidelines

Posted by Joe Paduda on Monday, February 22nd, 2021 | Comments

Several commenters purporting to be chronic pain patients responded to my post about the AMA’s bemoaning CDC’s opioid guidelines. 

Their stories were tragic; heartfelt; full of pain, suffering, and grief.  All decried the CDC’s guidelines as wildly misplaced, directly responsible for their terrible suffering, a governmental overreach, and a grossly misplaced intrusion of the government into the hallowed doctor-patient relationship.

Several attacked Dr Andrew Kolodny, making all kinds of ugly claims, attacking his ethics and denigrating his motivations. [Dr Kolodny is Executive Director of Physicians for Responsible Opioid Prescribing.]

And all but one came from email addresses that are bogus. I know that because I emailed each of them and asked them to confirm they sent a comment to MCM.  Here’s an example of one response.

I’ve known Dr Kolodny for over a decade. We met at the first few RxSummit conferences where colleagues introduced us. He was one of the first clinicians to raise the alarm about prescription opioids, and PROP has been instrumental in helping states, the CDC, and other governmental entities address the opioid crisis. I deeply respect Dr Kolodny – his relentless effort to stop the devastation caused by opioids has saved countless lives.

I do not know who is behind these attacks on the CDC and the attempts to libel and slander Dr Kolodny. I do not know if they are the product of the Opioid Industry, another example of their insidious effort to legitimize its criminal behavior and its lethal consequences. The Opioid Industry’s tentacles take the form of organizations that sound legitimate but are just mouthpieces for Big Opioids.

Big Opioid sponsors so-called patient advocacy groups, yet another example of Astroturfing (go to p 29, about halfway down, to see a description of the practice; or just search for Astroturf).

I also wrote on this several years ago.

The Astroturfers’ clever messaging convinces some chronic pain sufferers that the solution is more opioids, and anyone who disagrees is a self-serving, uncaring profiteer who is somehow profiting from their pain.

I hate Big Opioid and the people who propagate their lies. They are killing people, devastating families and destroying communities, all in the name of profits.

They are mass murderers – nothing less.

 

 

 

Feb
18

The prescription opioid crisis is far from over

Posted by Joe Paduda on Thursday, February 18th, 2021 | Comments

There’s still lots of money in the peddling of opioids, and lots of misinformation out there about opioid control efforts going too far.

Correlated? You tell me.

The American Medical Association sent a letter to the CDC claiming  “the nation no longer has a prescription opioid-driven epidemic...the AMA urges governors and state legislators to take action [to] remove …. arbitrary dose, quantity and refill restrictions on controlled substances.” [emphasis added]

In a letter sent to the AMA that was also published in the British Medical Journal, Physicians for Responsible Opioid Prescribing took the AMA to task, noting the AMA’s position is misguided at best:

 There is compelling evidence that many of those currently struggling with opioid dependence and addiction were introduced to opioids through use of medically prescribed opioids used to treat chronic pain. Medically prescribed opioids remain a common gateway to illicit opioid use and are themselves frequent causes of opioid addiction and overdose, even if illicit opioids currently cause the greater number of deaths.

PROP’s letter goes on to state:

Suggested dose and duration restrictions are not “arbitrary”, they are based on considerable evidence of when harm far exceeds benefit.

I do not know why the AMA is mischaracterizing the CDC guidelines. I do know opioid manufacturers are very, very good at working the levers of power, expert at manipulating government officials, and extremely generous in their political contributions.

The AMA’s anti-opioid guideline stance is kind of bizarre, bizarre as in Through the Looking Glass. On the one hand, it is mischaracterizing and decrying CDC guidelines that have been instrumental in mitigating the opioid disaster.

On the other, the AMA is claiming credit for reducing opioid use, deaths from overdoses, and various other positive trends, stating “the [AMA Opioid] task force’s recommendations have led to significant progress…”

That’s rather bold, considering:

And, of course, those CDC guidelines have been widely adopted by states, and are widely credited with reducing the damage done by opioids.

At times the guidelines have been misapplied, doctors have arbitrarily applied them, and patients have been abruptly cut off. That is NOT the fault of the guidelines, that are just that – guidelines. Rather, it is the fault of those mis-applying them to patients.

What does this mean for you?

The opioid crisis is far from over.

Controlling inappropriate use of prescription opioids is as important today as it has ever been.

Dec
18

Opioid deaths up…Perdue family completely blameless

Posted by Joe Paduda on Friday, December 18th, 2020 | Comments

Two members of the Perdue family, the folks who made tens of billions of dollars addicting patients to dangerous drugs, testified before Congress yesterday.  Both averred there was nothing they could have done to avoid/prevent the damage their company did.

Yesterday the CDC reported 81,230 drug overdose deaths occurred in the United States in the 12-months ending in May 2020.

Quoting the CDC:

This represents a worsening of the drug overdose epidemic in the United States and is the largest number of drug overdoses for a 12-month period ever recorded.

The Perdue family’s complicity in this national disaster is obvious and damning to everyone but the billionaires who’ve parked more than $10 billion of their profits from drug dealing offshore, safe from recovery efforts by American law enforcement and Perdue’s victims.

This from Kathe Perdue:

“I have tried to figure out, was there anything that I could have done differently? Knowing what I knew then — not what I know now?” said Dr. Sackler, who served on the board from 1990 to 2018. “There’s nothing that I can find that I would have done differently based on what I believed and understood then.”

Perdue on the Board through 2018, many years after Perdue Pharma’s criminal sales practices had been prosecuted, fines paid, settlements authorized. She was on the Board in 2007 when it authorized a $600 million settlement to resolve just one set of charges.

Oh, that represented 1/50th of the family’s net worth.

Two conclusions are possible – and only two.

Either Ms Perdue really couldn’t think of anything she could have “done differently” to stop her company’s ongoing, continuous and highly effective efforts to addict people, or she’s a bald-faced liar.

In the first instance, she’s a psychopath.

In the second, she lied to Congress.

What does this mean for you?

When are you going to sue these bastards for what they’ve done to your customers, employees, members, and organization?

Thanks to Steve Feinberg MD for the heads up on the CDC data.

Oct
6

Opioids – Deaths up, Sacklers likely to escape justice

Posted by Joe Paduda on Tuesday, October 6th, 2020 | Comments

Three news items hit the desk, ranging from bad to awful.

More than 73,000 of us died of drug overdoses in the 12 months ending February, 2020. That’s four thousand more deaths than the previous year.

(note graph below is for a slightly different time period)

And it is getting worse.

Preliminary data indicates the death count is up 13% so far this year.

The number of non-fatal overdoses in Vermont tripled this year, with almost 9 out of 10 involving fentanyl.

Meanwhile, the drug dealers directly responsible for much of the horror are about to escape with most of their billions in ill-gotten gains intact.

The drug dealers are the Sacklers, owners of Purdue Pharma. Purdue developed and marketed OxyContin; A recent study,  authored by the Wharton School, Notre Dame, and RAND reported “the introduction and marketing of OxyContin explain a substantial share of overdose deaths over the last two decades.”

This from a New Yorker article:

Behind the scenes, lawyers for Purdue and its owners have been quietly negotiating with Donald Trump’s Justice Department to resolve all the various federal investigations in an overarching settlement, which would likely involve a fine but no charges against individual executives. [emphasis added]

A lawsuit indicated over the last few years, the Sackler family has transferred billions of dollars offshore, effectively protecting those assets from the US justice system. This from the New Yorker:

In a deposition, one of the company’s own experts testified that the Sacklers had removed as much as thirteen billion dollars from Purdue.

The states have asserted in legal filings that the total cost of the opioid crisis exceeds two trillion dollars. Relative to that number, the three billion dollars that the Sacklers are guaranteeing in their offer is miniscule. It is also a small number relative to the fortune that the Sacklers appear likely to retain, which could be three or four times that amount. [emphasis added]

This country has jailed millions of poor people for decades for drug-related crimes; the Trump Administration appears poised to let the white-collar drug dealers most responsible for the opioid crisis walk away with billions of dollars they made addicting America.

What does this mean for you?

The Sacklers should rot in hell, but they will likely live on in unimaginable luxury. We should all be outraged.

 

Sep
25

Friday catch up

Posted by Joe Paduda on Friday, September 25th, 2020 | Comments

Pre-existing conditions, drug development, COVID-related GI problems, and marketing screwups…

First up, pre-existing conditions

Yesterday President Trump issued an executive order affirming “it is the official policy of the United States government to protect patients with pre-existing conditions.”

Well, yeah. It is today, because the ACA/Obamacare – which specifically protects patients with pre-existing conditions – is the law of the land, despite dozens of GOP efforts to overturn it. 

Couple other key issues.

  1. Without legislation signed into law, the Federal government – and the President – can’t enforce a “policy”.
  2. The executive order wasn’t released, so we don’t know what it actually says.
  3. The Trump Administration backs a lawsuit that would overturn the ACA and thereby eliminate pre-existing condition protections. 

What this means – don’t watch what someone says, watch what they do.

For more details on GOP and Democratic healthcare plans, click here.

Super-useful research on healthcare prices paid by private healthplans – kudos to RAND for updating their ongoing analysis. RAND compares prices paid by privately insurers – including work comp – to Medicare, allowing you to compare relative prices for individual facilities.

Thanks to Michael Costello for the link.

One takeaway – HCA hospitals are pretty expensive…(you can find prices for pretty much any hospital on RAND’s map)

Drug development

Pretty much all new drugs developed over the last decade relied on research you – the taxpayer – paid for.

That includes $6.5 billion of taxpayer dollars invested in remdesivir, one of the very few drugs found to be useful in treating COVID19.

COVID19

Alarming piece in JAMA yesterday reported patients with Acute Respiratory Distress Syndrome caused by COVID19 are at significantly higher risk for major gastrointestinal problems. Pretty solid science behind the research.

An earlier article highlighted the opioid epidemic during the COVID19 pandemic; there are definite limitations to the research due to small sample size and possible clinician bias. With those provisos, key takeaways include:

Good news – J&J will start Phase 3 trials of its vaccine. Unlike some other vaccines, it is a single shot and can be stored in a refrigerator for up to 3 months (others require two shots and must be stored at ultracold temps).

Marketing malfeasance

And lastly, an excellent article in the Harvard Business Review about marketing in current times.  A critical takeaway – do NOT just talk about social responsibility; DO it. Kudos to Starbucks; after mandating that workers could not wear anything with Black Lives Matter while working, the company realized it screwed up and reversed course.

For the umpteenth time, if you do screw up, apologize fully and without dissembling.  None of these “I’m sorry if anyone is offended” non-apology apologies; from the article:

With “cancel culture” as pervasive as it is, a one-time reaction is as good as letting an issue get ahead of you. Instead, treat apologies or mea culpas as the first steps of an ongoing dialogue designed to bring about thoughtful and meaningful progress.

Here’s hoping the White Sox turn things around in the upcoming series with the Cubs…and your team wins this weekend.

Be well.

Sep
4

Friday catch-up

Posted by Joe Paduda on Friday, September 4th, 2020 | Comments

Lots happened this week – here’s the big stuff.

COVID’s impact on work comp

WCRI is hosting a free webinar on the delivery of medical care and RTW during the pandemic.  Hosted by WCRI CEO John Ruser PhD and Randy Lea MD, the webinar will also include Mark Herbert MD, an infectious disease specialist.

Sign up here for the September 24 event, it kicks off at 2 pm eastern.

Drug prices

No, payers’ drug costs are not dramatically higher. In fact, net costs after rebates and other payments are flat to lower.  That’s one of the key findings from Adam Fein PhD’s analysis of the top PBM’s results. Kudos to Express Scripts, CVS, and Prime Therapeutics for publishing true cost data; one only wishes all PBMs did the same.

Ever wonder where all those new drugs come from?

Well, pat yourself on the back – because you, dear taxpayer, funded most of the initial R&D behind new drug development. Here’s the takeaway:

every new drug approved by the Food and Drug Administration (FDA) for the decade from 2010-2019 was associated with basic science funded by the NIH.

The IAIABC’s annual meeting kicks off next week; registration is still open here. Lots will be covered, including a discussion of COVID claims, presumption, fee schedule improvements, and of course EDI.

David Dubrof is PBM myMatrixx’ new Chief Sales Officer. I’ve known David for 20+ years; he is one of the very few “A” players in work comp services sales and a consummate professional. (myMatrixx is an HSA consulting client). David is all in on myMatrixx’ industry-leading push for price transparency.

How’s that budget process going?

Imagine trying to set up a curriculum for an unknown number of students with an unknown level of education. Or meal planning for an unknown group with different dietary requirements that are also unknown.

Well, that’s budgeting 2021. Never has that been so…fraught/uninformed/scary/pointless as it is today. If you need a break from trying desperately to figure out how to justify/rationalize your 2021 forecast and budget, read this.  It’s an excellent discussion of budgeting in a time of huge uncertainty.

Family is coming in this weekend to celebrate our new granddaughter’s arrival – have to say this is much-needed these days; the nastiness and bad news is getting to be a bit much.

Hope your weekend is filled with joy.

Sep
3

Will the FDA keep your family safe?

Posted by Joe Paduda on Thursday, September 3rd, 2020 | Comments

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

Friday fact day – COVID19 update, job losses, more uninsured, and executive move

Posted by Joe Paduda on Friday, August 28th, 2020 | Comments

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

Posted by Joe Paduda on Wednesday, August 26th, 2020 | Comments

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?