NNT in Pain Management: You've Been Right All Along

The National Safety Council's Dr. Don Teater, MD has penned a white paper that contains powerful data and interesting insights regarding the use of opioids for chronic non-cancer pain.  And it turns out, you've been right all along...

First, a pause for acronym education.  Just when you were getting a handle on MEDs... let me introduce you to NNT (number needed to treat).  This is a common measure in clinical studies that answers the question: how many people need to be treated with a given intervention for 1 person to receive a defined effect.  A lower NNT means the intervention is more effective (1 is the ideal... if you treat 1 person and that person achieves the defined effect, an NNT = 1 means you've got a really effective treatment).  A higher NNT means the intervention is less effective.

For instance, how many people need to be treated with Oxycodone 15 mg for 1 person to receive 50% pain relief?  Turns out the answer to that question is 4.6.

How many people need to be treated with a combination of ibuprofen 200 mg + acetaminophen 500 mg for 1 person to receive 50% pain relief?  Drum roll, please........ 1.6.

He also shares similar data from couple of other studies.

Why do providers turn to opioids so frequently in light of data such as this?  Why does this inherent belief exist that suggests opioids are more powerful analgesics?  Dr. Teater sites several reasons, but the two that caught my eye:

1. Opioids exhibit powerful psychotherapeutic effects not found with ibuprofen and acetaminophen.  If a patient's back hurts, tylenol and advil will work fine.  If a patient's back hurts and they're depressed, opioids are more likely to be perceived by the patient as effective.  This sounds obvious to most of us, but separating the clinical effects of opioids into "analgesic" vs. "psychotherapeutic" has significant implications for the use of these medications.  
2. The pharma companies have spent several billion dollars over two decades getting doctors comfortable with opioids.  Where there's money to be made... there's usually a rep standing by to help a doctor make a decision that may not be fully informed.  

Bottom line: You've been right all along.  For most patients, ibuprofen and acetaminophen are safer and more effective than opioids.  

Michael
On Twitter @PRIUM1

Guidelines That Matter, Part 2

Michigan is in the midst of developing opioid guidelines that matter (and yes, some guidelines matter more than others).  Guidelines that matter are specific, based on clinical evidence, and are tied to reimbursement.  Any guidelines that don't meet those criteria are mere suggestions that only help ensure the safety of injured workers in the most extreme circumstances (e.g., when a judge finally says to a doctor and patient, "that's enough with the opioids..." - and we all know how hard and expensive it is to get to that point).  Guidelines that matter exist within a regulatory structure and dispute resolution process that allows for mitigation of patient safety concerns without consistent involvement of judges.  Medical professionals should be able to work out these differences based on rational discussion and evidence based guidelines.

Michigan has taken a huge leap toward such an approach with the proposed draft of rules developed by the Health Services Committee of the state's Workers' Compensation Agency.  Paul Kauffman from Accident Fund chaired the committee and several other devoted members worked along with him for over a year on these draft guidelines.

Voices of dissent have cropped up, predictably from plaintiff's attorneys that fear this is simply a mechanism to take away needed medications from injured workers.  I don't think that's the case here.  Candidly, Michigan is a state where it's far too hard to ensure injured worker safety and far too easy for injured workers to remain on dangerous levels of opioids for too long.  These guidelines clearly aren't aimed at people who genuinely need pain management therapy.  Rather, these guidelines are aimed at ensuring the safe and effective use of these medications.

In an effort to provide some transparency to the discussion, here's the exact proposed language.  In it, you'll find a list of best practices all doctors should follow.  You'll also find that doctors can be reimbursed for checking the state's prescription drug monitoring database.


Rule 1008a. (1) In order to receive reimbursement for opioid treatment beyond 90
days, the physician seeking reimbursement shall submit a written report to the payer
not later than 90 days after the initial opioid prescription fill for chronic pain and every
90 days thereafter. The written report shall include all of the following:
 (a) A review and analysis of the relevant prior medical history, including any
consultations that have been obtained, and a review of data received from an automated
prescription drug monitoring program in the treating jurisdiction, such as the
Michigan Automated Prescription System (MAPS), for identification of past history of
narcotic use and any concurrent prescriptions.
 (b) A summary of conservative care rendered to the worker that focused on increased
function and return to work.
 (c) A statement on why prior or alternative conservative measures were ineffective or
contraindicated.
 (d) A statement that the attending physician has considered the results obtained from
appropriate industry accepted screening tools to detect factors that may significantly
increase the risk of abuse or adverse outcomes including a history of alcohol or other
substance abuse.
 (e) A treatment plan which includes all of the following:
 (i) Overall treatment goals and functional progress.
 (ii) Periodic urine drug screens.
 (iii) A conscientious effort to reduce pain through the use of non-opioid medications,
alternative non-pharmaceutical strategies, or both.
 (iv) Consideration of weaning the injured worker from opioid use.
 (f) An opioid treatment agreement that has been signed by the worker and the
attending physician. This agreement shall be reviewed, updated, and renewed every 6
months. The opioid treatment agreement shall outline the risks and benefits of opioid
use, the conditions under which opioids will be prescribed, and the responsibilities of
the prescribing physician and the worker.
 (2) The provider may bill the additional services required for compliance with these
rules utilizing CPT procedure code 99215 for the initial 90 day report and all
subsequent follow-up reports at 90-day intervals.
 (3) Providers may bill $25.00 utilizing code MPS01 for accessing MAPS or other
automated prescription drug monitoring program in the treating jurisdiction.
R 418.101008b Denial of reimbursement for prescribing and dispensing opioid
medications used to treat chronic, non-cancer pain.
 Rule 1008b. Reimbursement for prescribing and dispensing opioid medications may
be denied, pursuant to the act. Denial of reimbursement shall occur only after a
reasonable period of time is provided for the weaning of the injured worker from the
opioid medications, and alternative means of pain management have been offered.

Judge for yourself.

Michael
On Twitter @PRIUM1

Chronic Pain Malpractice Claims Are Rising

I've been in more than a few meetings with payers discussing the problems with opioids when someone wonders aloud, "Why aren't some of these patients suing their doctors?"

Turns out, they are doing just that... in increasing numbers.

A study of malpractice claims over the last 30 years presented at the 2014 Annual Meeting of the American Society of Anesthesiologists concludes that the number of claims related to chronic pain management is increasing far out of proportion to the growth in the number of pain management practitioners.  Further, the analysis shows the prescription medications are playing a significant role.

As a proportion of anesthesia malpractice claims, those claims related to pain management rose from 3% in 1980 to 18% in 2012.  Medication management claims increased from 2% to 17% of anesthesiology malpractice claims.

Perhaps more alarming: in the 1980s, death was the cited reason for a claim 6% of the time and severe injury for another 6% (the rest of the claims related to temporary and/or minor injuries).  After 2000, death was cited in 19% of claims and severe injury in 28%.  That's nearly half of all chronic pain malpractice claims.

Not only are chronic pain malpractice claims becoming more frequent, but the resulting injuries are becoming much more severe.

What to do?

I'm not a lawyer, but it strikes me that payers should probably be having conversations about provider network strategy and sticky things like subrogation, right?  Where does work comp leave off and med mal pick up?  When a payer has done all they can legally do to provide safe care for an injured worker and the doctor continues to prescribe absurd levels of opioids... what are the options when that injured worker doesn't wake up one morning?

Michael
On Twitter @PRIUM1

A Name You Should Know: Jack Conway

David Armstrong has written a piece on Bloomberg.com that should be required reading.  Not only does it recap the overarching legal strategies currently being pursued by various municipalities against manufacturers of painkillers, but it dives keep into Kentucky's battle - by far the longest and potentially most successful suit thus far.

Recall that in 2007, Purdue Pharma paid a $634 million fine in connection with inappropriate marketing of Oxycontin.  Of that fine, $160 million was specifically earmarked to reimburse the federal government and state governments for damages suffered by the Medicaid program.  Kentucky's share of that fine was to be $500,000.

Kentucky said "no thanks" and filed its own lawsuit.

Seven years later, we're as close as we've ever been to a trial and it's more likely than not that we'll see this trial play out at "ground zero" (Pike County prosecutor Rick Bartley's phrase, not mine) of the opioid epidemic.  For Purdue, whose chief financial officer is on record as saying that this could be a billion dollar case and would have a "crippling effect on Purdue's operations and jeopardize Purdue's long-term viability," this is nothing less than a "save the company" moment.

On the opposite side of the courtroom will be Kentucky Attorney General Jack Conway, a rising political star in the state.  He lost the 2010 US Senate Race to Rand Paul, but remains an up and comer in the Democratic party in Kentucky.  This is one of those cases in which an Attorney General can set himself up for future political wins.  And beyond that, I think he genuinely wants to do the right thing here.  And the right thing, according to Mr. Conway, is to hold Purdue accountable.  I met Mr. Conway and got to talk with him for a few minutes at last year's National Prescription Drug Abuse Summit in Atlanta.  He's the real deal.  He cares about the issue of prescription drug misuse and abuse.

The most interesting take-away from the article: Purdue hired an outside consultant to assess the likelihood of getting a fair trial in Kentucky.  The findings?

• 40% of Pike County residents knew someone who had run into criminal trouble because of an Oxycontin addiction;
• 33% knew someone who overdosed to was otherwise seriously hurt by the drug;
• 29% knew someone who had died;
• 90% agreed that Oxycontin had a "devastating effect" on the community.  

I'm not a legal expert.  I don't know if Purdue can get a fair trial in Pike County or not.  But either way, it sounds to me like there's going to be a fight - and a very public and very ugly fight at that.

Michael
On Twitter @PRIUM1

Guidelines: How to Make Them Matter

There has been a lot of talk in the last couple of weeks about medical treatment guidelines.  North Carolina, Tennessee, Arizona, and several other states are looking into adoption of guidelines.

There is a lot of discussion about "evidence-based" vs. "consensus-based" guidelines as well.  While I'm an outspoken proponent of the evidence-based variety, I recognize that local political conditions can make adoption of such 3rd party guidelines difficult.  Politics is a poor excuse - states can benefit significantly not only from the credibility of 3rd party guidelines, but also from the fact that providers of such guidelines work constantly to ensure those guidelines reflect the most contemporary view of the medical evidence.  Consensus-based guidelines (where a state medical director or agency gathers a bunch of stakeholders and they all decide what's best for injured workers in a given state) tend to be static - they age... and they tend not to age well.  They also tend to be subject to influence from outside parties with vested economic interests (see Louisiana as an example).

But the debate between the two competing approaches to guidelines is actually a sideshow, a distraction that prevents regulators from focusing on what matters most: enforcement.

When reading proposed or adopted treatment guidelines for a given state, make sure you explore the extent to which you can successfully challenge treatment that falls outside of the guidelines.  For instance, let's say a medical treatment guideline states that prescribing opioid analgesics in excess of 50 mg MED daily is not recommended (as the ACOEM guidelines suggest).  And assume you have a case where the doctor is prescribing 250 mg MED daily... and that doctor has been unresponsive to requests for discussion regarding the case and has not provided the rationale for why he's prescribing outside of the evidence based guidelines.  Question: Now what?  

There are states that have good answers to this question.

In Texas, if those opioids are N drugs, the answer is required pre-authorization based on a 3rd party guideline (Official Disability Guidelines) and a utilization review process that is statutorily supported and has clearly defined dispute resolution mechanisms.

I was encouraged to read that in Tennessee, the goal is to ensure that any adoption of treatment guidelines is consistent with existing utilization review regulations (which include the ability for a payer to subject any schedule II-IV medication used for the purposes of pain management for more than 90 days to utilization review).

Those are guidelines with enforcement mechanisms.  If the adoption of guidelines doesn't come with enforcement mechanisms, they're still worth having (because good doctors will still be responsive to guidelines).  But those guidelines won't be as valuable as they could be if appropriate enforcement mechanisms are in place (because not-so-good doctors will ignore contemporary medical evidence and continue to administer sub-optimal treatment until the payer stops paying for it).

Michael
On Twitter @PRIUM1

What's Old is New Again: The Real Opioid Wars

Addiction is not a new phenomenon.  Opioid analgesics aren't new either.  And as we fight our current war against the man-made epidemic of opioid misuse and abuse, let's not forget that actual wars have been fought over opium.  The Chinese and the British, in fact, fought two wars in the 19th century that hinged, at least in part, on the alarming growth in the number of opium addicts in China.  In fact, the first Opium War started when the Chinese government seized 20,000 chests of opium (or about 2.7 million pounds) belonging to the British East India Company.  The opium had been grown in India and transported to China by British traders who were making lots of money selling it to Chinese merchants.  (As an aside, the treaty that ended this war resulted in the cessation of Hong Kong to the British in 1841... the beginning of the political drama still playing out in Hong Kong to this very day).

Opium isn't new to the US either (see photo below).  In the early 20th century, opium addiction had become a sufficiently important public health issue that the Harrison Act of 1914 required doctors and pharmacists that prescribed and dispensed opium to register with the government and pay taxes on the sale of opium.  Nine years later in 1923, the US Treasury Department's Narcotics Division banned the sale of opium and other narcotics altogether (creating a vibrant black market for drugs that still thrives today).

Our public health and regulatory response to today's crisis is more nuanced and more measured than in the early 20th century, as it should be.  Opioid analgesics absolutely have a role to play in contemporary treatment of pain.  The challenge today remains how to balance the real needs of people in pain with the public health crisis that is the opioid epidemic.  But we've been here before and we'll figure it out.

Don't think history repeats itself?  Here's a "selfie"... 1920s style.

Have a great weekend.

Michael
On Twitter @PRIUM1

California: Predictions and Politics

The latest study from CWCI suggests that implementation of a Texas-like or Washington-like formulary could produce substantial savings in the CA work comp system on the order of $124-$420 million.  I was extremely impressed with the detailed methodology CWCI developed.  Not only did they dig into the formularies at the NDC level and build the analysis from the bottom up, Alex Swedlow and team also created a model that incorporates the effects of drug substitution in light of formulary implementation.  And it's not an overly simplistic approach, either.  They use the Medispan GPI number to assess the likelihood of substitution for drugs not included on the formulary.  The reader of this report learns more than just dollars and cents in CA; some of the key take-aways relate to the vast differences between the TX and WA approaches.  Bottom line: the report is educational and insightful and should be required reading.

There's just one major variable the report doesn't include: politics.

That's not a shot at CWCI - that's not their role, their mandate, or their mission.  But I couldn't help look at the numbers and think, "there's no way a closed formulary concept survives a fight in Sacramento."  I'm always encouraging people to avoid cynicism and here I am dishing it out.  But it's hard to imagine a politically diverse state like CA (was that diplomatic enough?) implementing something remotely close to what Texas did (a much more politically homogeneous state) or what Washington did (a monopolistic work comp system).  Keep in mind that even in Texas, the legislation that called for the creation of a closed formulary was signed into law in 2005.  Full implementation of that closed formulary finally occurred in 2013.  That's 8 years of regulatory wrangling in a state where less than 10 percent of injured workers are represented by attorneys and employers need not bother with work comp at all if they so choose.

On the other hand, we learned this morning from the Oregon Workers' Compensation Premium Rate Ranking Summary that California is the most expensive state in the country.  While there has always been a lot of debate about the methodology of this annual report, perhaps it's enough to create the burning platform CA so desperately needs to get a handle on medical costs.

Michael 
On Twitter @PRIUM1