An article about opioids and chronic pain featured in WorkCompCentral‘s [subscription required] professional columns section this week should be required reading for anyone involved in comp.
The explosive growth in the use of opioids among the general population, and specifically among workers comp claimants, is well-documented. When drug seeking hits the front page of USAToday, you know it’s well past the point of becoming a national disaster.
The piece, authored by Dr Steven Feinberg, provides an excellent overview of the issues inherent in managing pain with opioids – here are a few notable insights.
– there’s been a “dramatic increase in accidental deaths associated with the use of prescription opioids and also an increasing average daily morphine equivalent dose…”
– the lowest effective dose of opioids should be used along with patient agreements, random periodic and targeted urine testing
– at this time there is no clear evidence that long-term opiate therapy for chronic back pain is efficacious. (about half of work comp narcotic scripts are for claimants with back issues)
– ACOEM’s 2008 pain chapter guidelines suggest “opioids should not be used when there is no evidence they provide increased function.” Read this again – functionality is the key to prescribing, not pain.
There are a wealth of sources of information about appropriate usage of opioids freely available on the web. All the reputable ones are pretty much in agreement – for non-cancer patients, opioids may be helpful in facilitating a return to functionality, but long term usage is fraught with problems, many of them serious.
What does this mean for you?
If you don’t have a opioid strategy, now may be a good time to put one together, or ask your PBM for guidance.

Narcotic manufacturer Cephalon is back in the news, once again facing an investigation focused on the use of Fentora, a Schedule II narcotic, in workers comp cases.
Fentora is only FDA approved for breakthrough cancer pain – a condition quite rare in workers comp. The investigation apparently stems from allegations around Cephalon’s efforts to promote the use of Actiq(r) and Fentora(r), their highly potent narcotics for workers comp patients.
Those efforts were quite successful, estimates indicate ” in the first half of 2006 approximately 99% of the 187,076 Actiq prescriptions filled in the U.S. were not for cancer patients.”

Cephalon recently disclosed the following: “In January 2011, we received a subpoena … in connection with an investigation relating to Postal Service employees’ workers’ compensation claims. The subpoena requests that we provide to the Postal Service documents pertaining to FENTORA. We understand that this investigation is being conducted by the Postal Service in conjunction with the Civil Division of the United States Attorney’s Office in Philadelphia.” (from Cephalon’s latest SEC filing).
This latest investigation is not exactly the first instance of this type of conduct. In fact, in an earlier court ruling, the judge said “data suggested that more than 80% of patients using Actiq did not have cancer,” and “oncologists accounted for only 1% of Actiq prescriptions filled at retail pharmacies in the U.S.” [emphasis added] It is possible that oncologists are dispensing Actiq from their offices, although that’s rather difficult and complicated due to rules and regulations about storage and protection of Schedule II narcotics.
In 2007 Cephalon paid $425 million in fines and interest stemming from its promotion of off-label use of another narcotic opioid – our old nemesis Actiq, and another $6+ million to the state of Connecticut for similar reasons. They are also facing RICO (racketeering) and other charges related to allegations Cephalon’s promotion of Actiq and other drugs violated several laws.
As recently as 2008, Actiq was one of the top five drugs in workers comp measured by dollars spent for many payers; Fentora appears on most PBM’s lists of the top 25 drugs.
But it’s not just about the dollars. Actiq has been linked to dozens of deaths from overdose, including one case in Kansas where a doctor operating what can only be described as a ‘pill mill’ was indicted for involvement in fifty-six patients.
Roy Poses wrote four years ago that Cephalon had admitted Actiq was involved in the deaths of 127 people.
It is indeed possible more have died since then…
Thanks to Mike Whitely writing in this am’s WorkCompCentral for the tip.

A commenter (thanks Greg) on my post yesterday re NCCI’s research on physician dispensing noted “Going after the physicians, who are making efforts to recoup their steadily declining reimbursements, does not seem like the best strategy.”
Greg’s got a good point. There are many docs and occ med clinics that are dispensing medications for the right reasons, and not looking to make exorbitant profits. While their intentions are honorable, there are a couple concerns that bear mentioning.
First, as noted yesterday (and other times here on MCM) the proponents of physician dispensing often cite increased patient compliance, reduced hassle for the patient, and increased generic dispensing as justification/rationale for dispensing meds to the patient from the doctor’s office. I’ve not seen any studies that support the claim of increased compliance (I’ve seen claims that refer to studies but not the studies themselves. That said,I’ll stipulate that compliance is likely better when docs dispense drugs.
But, in addition to the higher costs perpetuated by repackagers and physician dispensing technology/services companies, there’s another potential concern with physician dispensing. Work comp claimants are usually treated by docs that haven’t seen the claimant before the occupational injury. While the WC doc certainly asks about prior medical history, current medications and the like, it is not uncommon for patients to forget which meds they take or be unable to accurately identify their drugs.
Not so big an issue if the claimant goes to their usual pharmacy, where the system will identify any potential conflicts and notify the dispensing pharmacist (assuming the claimant doesn’t go to a new pharmacy).
Potentially a bigger issue arises if the treating doc doesn’t get the full story, prescribes and dispenses meds that conflict with the claimants’ other meds. While there are some databases and sources of prescription data that docs may be able to tap into (or so I’m told), I don’t know if many of the physicians dispensing meds are doing so today – or, for that matter, even know of these resources.
That’s not to say the pharmacist’s database is foolproof – it most certainly isn’t. However, it’s a lot better than no database – or not accessing a database – at all.
In my view, physician dispensing can be appropriate if:
a) the price is pegged to the original manufacturer’s AWP, not some fabricated price from a repackager or dispensing services company;
b) the medications are appropriate and consistent with generally approved standards of care; and
c) the physician accesses the appropriate databases to verify the medication prescribed is safe for that particular patient.

For those who were following with bated breath the efforts of many to forestall the end of PBMs in Texas, Friday brought official confirmation of the rumors that we reported last week: the Division of Workers Comp published emergency regs [opens pdf of actual rules] that:
– make the Attorney General’s opinion moot;
– enable PBMs to operate in Texas after 1/1/11; and
– call on the legislature to pass a permanent fix.
So, on 1/1/11, PBMs can continue operating just as they do today.
Hallalooya.
Here’s the key language from DWC’s memo [opens pdf]:
“The rule amendments may remain in effect for a maximum of 180 days if renewed.
The adopted amendments permit insurance carriers to continue to reimburse prescription drugs dispensed on or after January 1, 2011 at rates either above or below the fees determined by the Division’s fee guideline using written contracts between insurance carriers and pharmacies or their processing agents, if applicable.”
I’m waiting for guidance on the 180 day issue: you’ll know when I do.

Greg Abbott, Texas’ Attorney General, has released his opinion re “Whether a workers’ compensation carrier may pay for a prescription drug at a rate lower than the fee rate allowed under the guidelines of the DWC…”
I’m no attorney. And being an attorney would be very helpful in this instance.
The key part of the four-page pronouncement is on page 3 and reads, in part:
“…although a WCHCN (work comp Health Care Network) must not provide prescription medication or services, an insurance carrier may enter into a contract with a WCHCN to obtain a contract with a health care provider to pay for prescriptions at a negotiated rate after January 1, 2011”
I’m not sure what this says. One interpretation I’ve heard is that payers must contract with an HCN, which then contracts with a PBM to provide pharmacy management services. However, a PBM may not qualify as a “provider”.
Another part of Mr Abbott’s opinion holds that there is no statutory minimum requirement for reimbursement under workers comp – and he’s pretty definitive about that. Then again, a later section appears to directly contradict this statement…
More to come – much more.

The Texas Division of Workers Comp (DWC) recently released proposed rules for work comp pharmacy billing. Along with the rules are what can perhaps best be described as an ‘extensive’ list of data elements DWC is looking to collect, a list that includes information that – in the view of most PBMs, retail pharmacies, and chains – is extremely sensitive and proprietary.
This effort is driven by provisions within the Texas Labor Code that, according to DWC, require DWC to adopt CMS’ most current reimbursement policies etc.
The draft – and I want to emphasize the form is still a draft – form requires submission of a comprehensive list of data elements, including the actual price paid for the script.
There are a number of concerns with this requirement. Here’s a quick list.
– revealing prices paid for individual scripts would potentially enable PBMs – and others – to determine the PBM’s contracted reimbursement rates with specific chains and retail stores. This is highly proprietary, extremely sensitive information.
– pharmacies will be quite concerned about release of data that would enable outside parties to find out what they charge specific PBMs. Many, if not most, PBM – pharmacy contracts employ a single rate nationwide, thus any entity that can access the Texas reporting information will quickly be able to determine reimbursement rates not only for that state, but likely all states.
– PBMs are not the only managed care entities that make their margin on the delta between what they receive from the payer and what they pay the service provider. Imaging and physical/occupational therapy networks, durable medical equipment/home health care vendors, designated doctor firms – all are reimbursed by the payer at one rate and pay their service providers – imaging centers, PTs/OTs, suppliers, physicians – another.
Given DWC’s current interpretation of the Labor Code, it would not be surprising if these other entities were required to reveal their pricing.
Anyone looking to provide comments on the proposed regs can do so by emailing rulecomments@tdi.state.tx.us. Of course, make sure you read the material on DWC’s website and consult counsel before taking up the virtual pen.