Thursday, April 21, 2011, 09:41 PM - Medical treatment under WCOne thing is clear about yesterday's Valdez en banc decision: the California Workers' Compensation Appeals Board has run out of patience with lawyers and claimants who attempt to circumvent the MPN and QME system.
The decision holds that where a worker is validly covered by an MPN, reports from doctors outside the MPN who treat are not admissible nor reimbursable.
In all likelihood the effects of the decision will be profound. Many non-MPN doctors who took treatment referrals from attorneys or other non-MPN doctors are likely to see their referrals dry up.
Yes, there will be ongoing fights about whether workers are bound by the MPN in the first place. And there will always be denied cases where non-MPN doctors will be able to treat.
But if a non-MPN doctor's report is neither admissible or reimbursable, the tendency to use such doctors will fade fast.
But the opinion of Commissioner Brass raises good points.
Brass concurred in this case because it appeared that the applicant left the MPN within 3 weeks on the advice of her attorney's firm.
But Brass writes that there may be good reasons in a particular case for a worker to go outside the MPN. He notes that "There may be a misdiagnosis, a lack of effective treatment, and/or an unreasonable delay in providing care".
Let's muse about this a bit.
Say the MPN doctor says you are fine, go back to work. You know you are
not fine but you try for a couple days. Your back is killing you and you wind up unable to walk. Getting up out of a chair you fall to the floor. Your 10 year old can't help you, so the ambulance is called. The hospital ER, which is not part of the MPN, runs a MRI. You have a herniated disc.
Does Valdez tell us that those hospital records are inadmissible? That that ER bill and MRI are not reimburseable?
If so, that's both shameful and unworkable.
One might understand the goal of having MPNs as a cost containment measure, and one might understand the impulse to cut down on manipulative attempts to self-procure treatment.
But workers' comp is dealing with a population that is in pain, sick, and often desperate. Situations develop that are resolved by ERs and emergency tests.
The board majority has now adopted a harsh rule which will be difficult to apply in such situations. That the board majority didn't address the concerns listed by Brass speaks poorly for their decision.
Suppose a worker has test, which the MPN doctor reads as negative. The worker then elects to get retested at a university-type center which has more sophisticated test equipment. The worker pays for the test, which documents the condition after all.
The parties then proceed to a panel QME or AME. Defense counsel writes to applicant's lawyer, objecting to the positive test results being shown to the panel QME or AME. The defense counsel claims that under the rationale of Valdez (and the recent Scudder panel decision), that the non-MPN test results are inadmissible, arguing that they are "fruits of the poisonous tree" and should not be shown to the QME/AME.
In an accepted skin cancer case the MPN doctor says you don't have now have melanoma cancer. The non-MPN doctor says you do. They operate on you and remove it. Not admissible? Not evidence the QME can see?
Again, if the comp system has devolved this far, to the point of this much procedure over substance, then the system may not be worth saving.
One could spend an evening easily devising a number of such real world examples of how disputes and medical diagnoses unfold. Many of those situations have nothing to do with avaricious attorneys who are attempting to subvert the MPN system.
Yet, as Brass notes, the WCAB majority has set forth a ham-handed rule that is overbroad.
Wednesday, April 20, 2011, 10:33 PM - Medical treatment under WCCalifornia's Workers' Compensation Appeals Board has rendered an em banc decision on medical treatment and MPNs.
The case, Elayne Valdez v. Warehouse Demo Services, is likely to have a significant impact on the California workers' comp system.
In Valdez, there may have been a valid MPN. I say may, because the WCAB decision defers a determination on that issue, but analyzes the case on the assumption that there was probably a valid medical network.
For those of you late to the party, employers and insurers can set up networks, forcing workers who do not have a valid predesignation on file to treat with a doctor on the network.
Around the state, different patterns of workers' comp practice exist.
In Southern California workers and attorneys have often sought to regain
"medical control", finding technicalities to allow the worker to escape the MPN network and treat elsewhere. With a large number of doctors willing to provide such treatment, often on a lien, workers would sometimes treat off-network.
In Northern California this is seen much less frequently, probably because there is not a large pool of non-MPN physicians willing to "treat on a lien".
In Valdez, Ms. Valdez treated with an MPN doctor for about three weeks.
At that point, she apparently was referred to a non-MPN doctor by her attorney.
Valdez did not attempt to change doctors within the MPN. Nor did she invoke the infrequently used procedure to seek a formal "second opinion".
Nevertheless, at trial level the Workers' Comp Judge based an award of temporary total disability on the opinion of the non-MPN physician, Dr. Nario.
In deciding the case, a majority of the WCAB commissioners (Joseph Miller, James C. Cuneo, Deidra E. Lowe and Alfonso J. Moresi, with separate concurring and dissenting opinions from Frank M.Brass and Ronnie G. Caplane) take a hard line.
Where unauthorized treatment is obtained outside a validly established and properly noticed MPN, reports from the non-MPN doctors are inadmissible, and may not be relied on.
In a blow to the economic model of many of the non-MPN providers, the Valdez case indicates that the employer and insurer are not liable for the cost of non-MPN reports.
To reach this result, the majority makes several key points.
First, they note that workers can change doctors within the MPN and can invoke a multi-level appeal process within the MPN.
Second, they note that Labor Code 4061 and 4062 are QME process remedies where a party disputes determinations regarding medical treatment and diagnosis issues.
Third, they distinguish Labor Code Section 4605 and 5703(a) sections which appear to allow workers access to consulting or attending physicians at the worker's expense.
In a direct retort to Caplane's dissent, the majority notes that
"It is those applicants who have chosen to disregard a validly established and properly noticed MPN, despite the many options to change treating physicians and challenge diagnosis or treatment determinations within the MPN, and to dispute temporary or permanent disability opinions under sections 4061 and 4062 outside the MPN, who have removed themselves from the benefits provide by the Labor Code."
I'll be providing further analysis and reaction to this decision in a post in the next few days. Stay tuned.
Meanwhile, here is a pdf version of Valdez vs. Warehouse Services (2011):
http://www.dir.ca.gov/wcab/EnBancdecisi ... aldezE.pdf
Tuesday, March 22, 2011, 12:30 AM - Medical treatment under WCNote: this post includes a correction to an earlier version of this post;;;
I'm not surprised that I received some response to my recent post, "The Outliers", which focused on a recently released study of opioid prescribing practices in California workers' comp.
That study, by the insurance industry's California Workers" Compensation Institute, has been picked up in scads of articles in various media outlets.
But in the interest of fairness, I'll share some comments from readers who present different perspectives on the issue.
I offer their comments to further stimulate debate, realizing that on the one hand anything that comes between workers' and doctors is anathema to some, while on the other hand some in the employer community would be happy to place further limits on treatment access.
One injured worker writes to point out that not all workers on opiates for chronic pain are "dope fiends". Reacting to the perceived vilification of workers treating for chronic pain, he notes that
"'I've been on Opiates for 5-6 years now, since they're the only medication that works for me, a chronic pain patient.
My Doctor sees me once a month, writes me a prescription, and I take it to the pharmacy.
The article you posted about Doctors making money off of handing out them doesn't apply in my case, and I use my medication judiciously and as prescribed.
Please mention in your Blog that all truly injured workers aren't dope fiends who use drugs for fun. If I didn't have mine I wouldn't be able to use my hands or arms."
A friend forwards me a reaction to my post and the CWCI study sent to him from a medical staffer at California workers' comp insurer:
"As to this study, there is no doubt that there is a lot of abuse in prescribing psychotropic and pain medications. Duh. However, it is not surprising that 3% of the doctors write the bulk of these prescriptions. I would surmise that these are the pain management guys who, for all their other faults, end up with the worst patients and therefore their prescribing patterns are not necessarily abusive. Its like saying that the top trauma hospital has a higher death rate per admission than Podunk Community. It's a good bet that the top trauma hospital has a much sicker patient population than Podunk Community. Similarly, neurosurgeons pay a higher malpractice rate than chiropractors or weight-loss doctors.
Note correction: an earlier version of this post included a critique passed on to me from a commentator which misstated authorship of the CWCI opioid study. CWCI study co-author Alex Swedlow has kindly noted that the sole authors of the study were himself, John Ireland of CWCI and Gregory Johnson, Ph.D, an independent consultant specializing in insurance and healthcare issues. Arnold Milstein was not involved with this study. My apologies to the CWCI authors and Dr. Milstein for this error.
This industry doctor goes on to argue his point, which I'll share here even though I'm not vouching for his views:
"Not to say that abuse by the pain management doctors is not a problem. It is. However, the solution to this problem is not simply going after the prescribing patterns, but rather the whole paradigm that has accepted this whole notion of "chronic pain management" as a validated medical treatment program that should be available to anyone who has pain that doesn't get better with standard treatments. This is a shortcoming of the ACOEM Guides, the ODG Guidelines and the Labor Code and needs to be addressed with honest outcome studies. The reason this practice flourishes in the workers' comp system is because it is predicated on the false notion that these programs actually get people back to work. It's the same argument that has allowed spinal fusion and other devices of medieval torture to become a standard of care for so long, the lack of meaningful studies to the contrary."
But wait. There's more.
My friend forwards an article from the March 6,2011 New York Times, by Gardiner Harris entitled, "Talk Doesn't Pay, So Psychiatry Turns Instead to Drug Therapy":
http://www.nytimes.com/2011/03/06/healt ... inerharris
Making his point, my friend notes that in our society we have trended toward a pharmaceutical fix to problems. Psychiatrists generally can't make it by doing on the couch counseling and analysis. Even the state-adopted treatment guidelines seem to favor medications over physical therapy, gym memberships and such modalities. Whollistic approaches and Eastern medicine type approaches aren't often allowed. So is the system reaping what it has sowed?
Three different approaches. All food for thought.
Monday, March 7, 2011, 09:35 PM - Medical treatment under WCA few doctors doing an outsized share?
Where have we heard this before?
In 2010 CHSWC taught us that 3.9% of QMEs, often with sham "offices" in dozens of zip codes, were conducting 40% of evaluations :
That's a supersized share.
Now, courtesy of a CWCI study, we learn that the top 10% of doctors who prescribe Schedule II opioids for injured workers in California account for nearly 80% of all workers' comp prescriptions for these drugs.
That's a supersized share.
The CWCI study claims that these Schedule II opioids (such as oxycodone, fentanyl, morphine and methadone), are being prescribed for even minor back strains and orthopaedic sprains.
Expensive, addictive, and potentially lethal, these drugs are said to be prescribed more often and in more potent quantities by the most frequent prescribers.
It's a topic that makes me uncomfortable. I'm seen a couple of clients wreck their lives through their pain cocktails. At least one overdosed.
The study, by CWCI researchers Alex Swedlow, John Ireland, and Gregory Johnson, can be downloaded in pdf format here:
Longtime comp system vet Bill Zachry of Safeway charged in an e-mail blast that
"...the abuse of opioids is just a tip of the iceberg. Opioid abuse is part of a larger problem that a relatively small group of physicians and applicant attorneys perpetuate in Southern California. It is my understanding that this small group of physicians and attorneys also account for many of the Southern California medical treatment liens for treatment that was not performed in accordance with evidence based medicine and that was provided outside of the Medical Provider Networks."
Zachry went on to opine that
"it is my opinion, that due to the massive profits that they get from self-dispensing, there is an inappropriate financial incentive for doctors to do the wrong thing, and, as a result, they are destroying the lives of injured workers."
Zacrhry did not note it in his e-blast, but a recent RAND study noted that financial incentives may be playing a role in increased dispensing of controversial "medical foods" and "nutriceuticals", particularly in Southern
These developments will not make for appealing headlines for injured workers, attorneys and their friends in the medical community.
Outliers, be they be outsized QME mills or Dr. Feelgood pain-med prescribers, will come under increased scrutiny.
No amount of convention schwag or limo rides to the after-party should blind those in the system to what is going on. Abuses can kill the golden goose. We know that from past experience.
Zachry suggests that the best ways to stop opioid abuse is through a workers' comp prescription formulary and through limiting dispensing out of physician offices.
Among Zachry's suggestions:
-payers can achieve some limits by a "carefully crafted MPN contract"
-that employers and carriers have a pharmacy network with a formulary
More on those concepts in the future. Stay tuned.
Wednesday, February 2, 2011, 09:35 PM - Medical treatment under WCWho doesn't love a good food fight?
Every kid remembers the fantasy of smothering Uncle Elmer's face in a
banana cream pie. I'll never forget the battle of the sloppy joes when there was a power failure at the dining hall my freshman college year.
And who could forget the cinematic food fights in Animal House, The Great Race, and Blazing Saddles?
But now the comp world has its own food fight.
Not an actual gooey slinging fest, mind you. But "food" is at the heart of the struggle. This time the struggle over "medical foods".
Here's the background of the controversy:
Recently RAND researchers have produced a study for CHSWC (California Commission on Safety, Health and Workers' Compensation) on compound drugs and medical foods.
Written by Barbara O. Wynn, the study is titled "Use of Compound Drugs, Medical Foods, and Co-Packs in California's Workers' Compensation Program". You can find a pdf of the study here:
http://www.dir.ca.gov/chswc/Reports/201 ... -Packs.pdf
Public comment on the paper is requested by March 1, 2011:
http://www.dir.ca.gov/chswc/info_bullet ... tin08.html
It's likely that the eventual CHSWC report on the issue will be a basis for legislative action.
The RAND study notes that "the issues surrounding compound drugs, medical foods, and co-packs rest on uncertainties regarding whether the products are medically appropriate...". RAND recommends that "The MTUS should be updated and expanded to address compound drugs as a product class" as well as "the medical appropriateness of medical foods".
Moreover, the RAND study concludes that "physician-dispensing creates financial incentives that affect use of compound drugs, medical foods, and co-packs"and suggests various legislative or regulatory fixes to control abuse.
But the purveyors of "medical foods" are fighting back.
A recent article by reporter Greg Jones in workcompcentral.com
quotes extensively from comments by Dr. William Shell, CEO of Physician Therapeutics, a Los Angeles pharmaceutical company, a subsidiary of Targeted Medical Pharma Inc. (kudos to workcompcentral.com as usual for its excellent day in and day out coverage of the California workers' comp scene)
It appears that Physician Therapeutics has been awarded a $750,000 National Institutes of Health grant from the U.S. government to study medical foods and co-packs as alternatives to some of the side effects of opioids and non-steroidal anti-inflammatories. Apparently the study will focus on medical foods for Gulf war syndrome victims and elderly with sleep disorders.
Wasted money or visionary use of funds by your government under the Patient Protection and Affordable Care Act?
Time will tell whether the research is meritorious or bogus, but the suppliers and providers of medical foods and co-packs appear ready to fight back in the comp system.
The Physician Therapeutics website claims that "all medical food products use "Targeted Cellular Technology" (trademark), "a patented process that allows very small quantities of neurotransmitter precursors to enter the cells and produce specific neurotransmitters".
Physician Therapeutics further claims that:
"This five component system includes:
A neurotransmitter precursor supplied as an amino acid
A neuronal uptake stimulator
A neuron activator
An adenosine antagonist, such to disinhibit the neuron
An attenuation inhibitor of the precursor response a well known precursor phenomena
This proprietary application of neurotransmitter science is designed to promote the production and release of the neurotransmitters norepinephrine, epinephrine, dopamine, serotonin, acetylcholine, histamine, glutamine and nitric oxide.
Medical food formulas synchronize the fluctuating demand for neurotransmitters with the availability of the precursor supply, which is especially important for processes that are controlled by circadian rhythms, such as utilization of arginine for the production of nitric oxide. It is important to note that maintaining adequate neurotransmitter levels in disease states is not a pharmaceutical mechanism of action (MOA), but is achieved via a dietary management mechanism, the nutritional ingestion of the required distinctive nutrients in the specific quantities needed to modulate cellular responses."
However, in 2010 Physician Therapeutics received a warning letter from the FDA. The FDA letter addressed to CEO William Shell, stated:
"Dear Dr. Shell:
On (b)(4), FDA issued a warning letter to (b)(4), (copy attached). As explained more fully in that warning letter, certain drug products that (b)(4) has manufactured are new drugs that lack approved applications as required under the Federal Food, Drug, and Cosmetic Act (the Act). Based on information obtained during FDA's inspection of from (b)(4), your firm contracted or otherwise arranged with (b)(4) manufacture one or more drug products that your firm distributes. These drug products include, but are not necessarily limited to:
• Theracodophen-650 Convenience Pack (Hydrocodone 10 mg, Acetaminophen 650 mg, and Theramine);
• Strazepam Convenience Pack (Temazepam 15 mg and Sentra PM);
• Gabazolamine-0.5 Convenience Pack (Alprazolam 0.5 mg and GABAdone);
• Gaboxetine Convenience Pack (Fluoxetine 10 mg and GABAdone);
• Trazamine Convenience Pack (Tradazone 50 mg and Sentra PM);
• Senophylline Convenience Pack (Theophylline 100 mg and Sentra PM);
• Therapentin-60 (Gabapentin 200 mg and Theramine);
• Prazolamine (Carisoprodol 350 mg and Theramine);
• Sentradine (Ranitidine 150 mg and Sentra PM);
• Therafeldamine (Piroxicam 20 mg and Theramine)
The above products are drugs within the meaning of section 201(g) of the Act, [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, they are "new drugs" within the meaning of section 201(P) of the Act [21 U.S.C. § 321(P)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301 (a) and (d) and 505(a) of the Act [21 U.S.C. §§ 331(a), (d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an FDA approved application is in effect for the drug. Based on our information, you do not have any FDA-approved applications on file for these drug products.
Additionally, because the above prescription drug products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses, as described in 21 C.F.R. § 201.5. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(1)(1) of the Act [21 U.S.C. § 352(1)(1)]. Because the products lack required approved applications, they are not exempt under 21 C.F.R. § 201.115 from the requirements of section 502(1)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these products without approved new drug applications violates sections 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].
Further, as explained in the warning letter dated (b)(4) to (b)(4) the above drug products are adulterated under 21 U.S.C. § 351(a)(2)(B), and thus your firm may not introduce or deliver them for introduction into interstate commerce, 21 U.S.C. § 331(a).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. In particular, violations cited in this letter are not necessarily limited to drug products manufactured by (b)(4) and may apply to all drug products that you market and distribute without FDA-approved applications. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your film complies with all requirements of federal law and FDA regulations.
You should take prompt action to Correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and,' injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer market the above products, your response should so indicate, including the reasons that, and the date on which, you ceased production.
Your reply should be sent to:
Daniel Cline, Acting Director
Los Angeles District Domestic Compliance Branch
U.S. Food & Drug Administration
Irvine, CA 92612
If you have any questions regarding this letter, please contact John J. Stamp, Compliance Officer, at (949) 608-4464."
http://www.fda.gov/ICECI/EnforcementAct ... 208680.htm
Shell was quoted in workcompcentral.com as saying that "our response to the warning letter took the position that our medical foods are both safe and effective for their intended use, which is as precursors to neurotransmitters and therefore the definition of a drug is "safe and effective for their intended use".
Further, Shell was quoted as saying that "the issue is whether these are new drugs or old drugs, and since they were grandfathered in in 1962, amino-acid preparations are not a new drug".
In fairness to both Shell and the FDA, I've not seen followup correspondence that my have been generated by the company or regulators. Physician Therapeutics' website does not provide those details.
When a new AD of the Division of Workers' Compensation is appointed, the efficacy of "medical foods" and the scientific data thereon can be hashed out as part of an amended MTUS. As part of such a process, medical foods manufacturers may be able to produce their data, presumably data on which the NIH relied in providing significant public research funding.
All of this is a "food fight" that needs to take place in the sunshine of scientific peer review and open public policy analysis.
But Shell did make one point in comments to workcompcentral that may be worth noting. Shell apparently claims that his company was not contacted by the RAND authors of the study performed for CHSWC.
Going forward on these types of studies, it would probably serve the comp community (and CHSWC) well for RAND or other CHSWC study contractors to contact subject "stakeholders" for their input and comment, even if only to "solicit their side of the story" and create an extra appearance of fairness. This has been a problem with a recent study on liens, where many providers claimed that they were not consulted about their perspective on the widely perceived lien problem before a report was generated.
For more on Physician Therapeutics, you can see their website:
And you can find this statement from Dr Shell, who has a resume that features a long association with Cedars-Sinai Hospital in Los Angeles as well as a stint as an associate professor at UCLA School of Medicine: