As we wage the daily battle against the over-utilization of opioids in workers' compensation, it's important to recognize an increasingly important ally in the physician community: Physicians for Responsible Opioid Prescribing (PROP).
Just this week, PROP led the way on a petition to the FDA to change the labels on opioid painkillers to prohibit their use for moderate pain, add a max daily dose, and only allow patients to take the drugs for 90 days unless they're being treated for cancer-related pain. This is a bold petition and an even bolder request, but PROP is as serious about this issue as they are credible.
PRIUM relies on the PROP web site for training materials, both for internal staff as well as our network of physician reviewers. The videos on the site are absolutely phenomenal and they help us to orient new employees and our physician partners to the seriousness of the issue, the complexities of dealing with the issue, and the dedication required to ensure positive clinical outcomes.
Dr. Andrew Kolodny is the President of PROP. He is working tirelessly to bring awareness and solutions to one of the great healthcare crises of our generation. He speaks at conferences, he engages with physician groups, he speaks to payers, and he writes editorials published in the NY Times. His message is consistent, credible, and critical. I've met Dr. Kolodny a few times (he even bailed me out when I was speaking at a conference and had technical issues trying to show a PROP video - he kindly stood up and delivered the message himself!). His passion for the appropriate use of prescription narcotics is powerful.
Get to know PROP. They're helping us in the payer/employer community every day. Let's find some ways we can help them.
Michael
On Twitter @PRIUM1
Thursday, July 26, 2012
Courage in Illinois: Doing the Right Thing on Repackaging
Illinois is working through a regulatory change that would cap the price of repackaged drugs at AWP + a dispensing fee. As I've previously argued, this is the right way to go about changing the practice of physician dispensing. By eliminating the financial incentive to dispense medications, but maintaining the physician's right to do so for the rare cases where an injured worker may truly benefit from getting scripts in the office, the state leaves all stakeholders with the right mix of incentives.
What's unique about Illinois, however, are the two votes that took place within the last few days. The Illinois Workers' Compensation Commission voted 9-1 to move ahead with revisions to drug repackaging rules in the state, despite a 4-3 vote from the medical advisory board NOT to proceed.
At the risk of appearing dramatic, I view this relatively small procedural victory as a potential tipping point in the legislative/regulatory landscape around drug repackaging and physician dispensing. Predictably, the insurance and employer community likes the new rule while the physician community is opposed. But in this case, the physician community said "no" and the WCC moved forward anyway. They did so because the evidence, data, and logic tells them this is the right thing to do.
Progress.
Michael
On Twitter @PRIUM1
What's unique about Illinois, however, are the two votes that took place within the last few days. The Illinois Workers' Compensation Commission voted 9-1 to move ahead with revisions to drug repackaging rules in the state, despite a 4-3 vote from the medical advisory board NOT to proceed.
At the risk of appearing dramatic, I view this relatively small procedural victory as a potential tipping point in the legislative/regulatory landscape around drug repackaging and physician dispensing. Predictably, the insurance and employer community likes the new rule while the physician community is opposed. But in this case, the physician community said "no" and the WCC moved forward anyway. They did so because the evidence, data, and logic tells them this is the right thing to do.
Progress.
Michael
On Twitter @PRIUM1
Tuesday, July 24, 2012
Drug Repackaging: WCRI and AHCS
From time to time, an important report is released that thoroughly covers a critical topic in our industry. And sometimes, others provide such thorough analysis that I find it difficult to add to what's already been said. Such is the case with WCRI's new report on physician dispensed repackaged drugs in work comp.
David DePaolo's overview of the report is excellent and he provides a well balanced view of the controversy this report has sparked.
Joe Paduda takes on the AHCS critique of the report. His rebuttal is spot on and contains important insights for policy makers that will surely confront AHCS as the legislative/regulatory process evolves on a state by state basis to address this issue.
Bottom line: The report is thorough, unbiased, data-driven, and eye-opening. The issue of physician dispensing of repackaged drugs is a major weak spot in many jurisdictions' work comp statutes and rules. A legislative/regulatory solution is needed and I think Connecticut's new rule provides an excellent template.
Michael
On Twitter @PRIUM1
David DePaolo's overview of the report is excellent and he provides a well balanced view of the controversy this report has sparked.
Joe Paduda takes on the AHCS critique of the report. His rebuttal is spot on and contains important insights for policy makers that will surely confront AHCS as the legislative/regulatory process evolves on a state by state basis to address this issue.
Bottom line: The report is thorough, unbiased, data-driven, and eye-opening. The issue of physician dispensing of repackaged drugs is a major weak spot in many jurisdictions' work comp statutes and rules. A legislative/regulatory solution is needed and I think Connecticut's new rule provides an excellent template.
Michael
On Twitter @PRIUM1
Thursday, July 19, 2012
Suboxone: Our View
I'm seeing and hearing a lot of advertising for www.turntohelp.com here in the Atlanta area. I don't know if it's a nationwide push or unique to our market, but the ad buy here is significant.
Of course, the site is sponsored by Reckitt Benckiser, makers of Suboxone - a drug "indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychological support."
On the one hand, it's difficult to justify the suggestion that the solution to dependence on pills... is more pills. Different pills, clearly, but still a pharmacological solution to a pharmacological (and psychological) problem. Welcome to 21st century medicine. Also troubling is how often we see Suboxone introduced without the weaning of the other opioid medications. We see this on cases PRIUM reviews. Sometimes, the doctor is choosing to prescribe Suboxone for chronic pain management (which represents off-label use, but is the doctor's right to do). Sometimes, the doctor intends to wean the other medications, but finds the patient unable or unwilling to participate in the weaning process. Why Suboxone isn't immediately discontinued in this scenario isn't clear, but we see if often enough that PRIUM's physician reviewers are clearly concerned about the appropriate use of this medication.
On the flip side, we do see cases here at PRIUM where Suboxone is used appropriately and successfully. And I personally know a few people that have been weaned off of very high dose narcotics successfully through the use of Suboxone.
Bottom line: If you see Suboxone on a claim, make absolutely sure that the physician is DATA 2000 certified and that the drug is being used appropriately. Close monitoring is key to a successful outcome.
Back to the web site for moment: www.turntohelp.com is actually a tremendous resource. Clearly, RB put a lot of time, effort, and study into crafting an easy to navigate, informative, balanced approach to the treatment of opioid dependence. Candidly, it took me about 10 minutes before I ended up on the Suboxone web site (I thought it would take less than a minute). The information on the site emphasizes the need for counseling and psychological support and goes to great lengths to discuss all available treatment options. RB is clearly not going for a direct sell of Suboxone, but rather counting on the fact that if more people seek treatment, some percentage may end up on Suboxone. There are plenty of other sites you can leverage to get the same information, but I've not found any as well organized or easy to navigate.
Certainly open to recommendations, though...
Michael
On Twitter @PRIUM1
Of course, the site is sponsored by Reckitt Benckiser, makers of Suboxone - a drug "indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychological support."
On the one hand, it's difficult to justify the suggestion that the solution to dependence on pills... is more pills. Different pills, clearly, but still a pharmacological solution to a pharmacological (and psychological) problem. Welcome to 21st century medicine. Also troubling is how often we see Suboxone introduced without the weaning of the other opioid medications. We see this on cases PRIUM reviews. Sometimes, the doctor is choosing to prescribe Suboxone for chronic pain management (which represents off-label use, but is the doctor's right to do). Sometimes, the doctor intends to wean the other medications, but finds the patient unable or unwilling to participate in the weaning process. Why Suboxone isn't immediately discontinued in this scenario isn't clear, but we see if often enough that PRIUM's physician reviewers are clearly concerned about the appropriate use of this medication.
On the flip side, we do see cases here at PRIUM where Suboxone is used appropriately and successfully. And I personally know a few people that have been weaned off of very high dose narcotics successfully through the use of Suboxone.
Bottom line: If you see Suboxone on a claim, make absolutely sure that the physician is DATA 2000 certified and that the drug is being used appropriately. Close monitoring is key to a successful outcome.
Back to the web site for moment: www.turntohelp.com is actually a tremendous resource. Clearly, RB put a lot of time, effort, and study into crafting an easy to navigate, informative, balanced approach to the treatment of opioid dependence. Candidly, it took me about 10 minutes before I ended up on the Suboxone web site (I thought it would take less than a minute). The information on the site emphasizes the need for counseling and psychological support and goes to great lengths to discuss all available treatment options. RB is clearly not going for a direct sell of Suboxone, but rather counting on the fact that if more people seek treatment, some percentage may end up on Suboxone. There are plenty of other sites you can leverage to get the same information, but I've not found any as well organized or easy to navigate.
Certainly open to recommendations, though...
Michael
On Twitter @PRIUM1
Tuesday, July 17, 2012
CMS, Part D, and Opioids: A Familiar Approach
CMS has asked for additional public comment on its plan to improve drug utilization review for Medicare Part D participants. I'd provide a link to the memo, but it was emailed to me and I can't seem to locate the file on the CMS web site (go figure). If you really want to get your hands on it, let me know and I can email it to you.
Turns out, CMS has found that approximately 0.7% of the total Part D population (or about 225,000 beneficiaries) received more than 120 mg MED daily for at least 90 consecutive days in 2011. Kudos to CMS - not only for recognizing the clinical value of the 120 mg MED threshold, but also for citing the State of Washington's Department of Health as a source.
The current CMS approach has a lot going for it. (Candidly, it looks a lot like our process for addressing these claims, so no surprise that we're supportive). In summary, it calls for the following:
1) The Part D plan should have a documented policy for addressing overutilization of opioids.
2) There should be clinical triggers, defined by the plan, to flag certain beneficiaries for review.
3) Protocols should be developed to eliminate from review those beneficiaries with legitimate need for high dose opioid therapy (i.e., cancer diagnoses).
4) The plan should be prepared to communicate directly with prescribers of the opioid medications, both in writing and telephonically, to address patient safety concerns, medical appropriateness, and medical necessity. Further, the CMS approach calls for the conversation to be "clinician-to-clinician" (we would suggest a slightly more specific definition of "peer-to-peer", but CMS leaves that to the discretion of the individual plan).
5) The results of the intervention should be incorporated into future claims management decisions, most obviously via a beneficiary-level claim edit (what we would think of as a PBM prior auth or block on a particular medication).
6) Should a prescriber not cooperate, the CMS approach gives the plan the power to put such beneficiary-level claim edits in place to protect the patient's safety.
7) Some sort of case management activity is necessary to ensure future compliance.
Solid start.
How does this compare with your organization's approach?
Michael
On Twitter @PRIUM1
Turns out, CMS has found that approximately 0.7% of the total Part D population (or about 225,000 beneficiaries) received more than 120 mg MED daily for at least 90 consecutive days in 2011. Kudos to CMS - not only for recognizing the clinical value of the 120 mg MED threshold, but also for citing the State of Washington's Department of Health as a source.
The current CMS approach has a lot going for it. (Candidly, it looks a lot like our process for addressing these claims, so no surprise that we're supportive). In summary, it calls for the following:
1) The Part D plan should have a documented policy for addressing overutilization of opioids.
2) There should be clinical triggers, defined by the plan, to flag certain beneficiaries for review.
3) Protocols should be developed to eliminate from review those beneficiaries with legitimate need for high dose opioid therapy (i.e., cancer diagnoses).
4) The plan should be prepared to communicate directly with prescribers of the opioid medications, both in writing and telephonically, to address patient safety concerns, medical appropriateness, and medical necessity. Further, the CMS approach calls for the conversation to be "clinician-to-clinician" (we would suggest a slightly more specific definition of "peer-to-peer", but CMS leaves that to the discretion of the individual plan).
5) The results of the intervention should be incorporated into future claims management decisions, most obviously via a beneficiary-level claim edit (what we would think of as a PBM prior auth or block on a particular medication).
6) Should a prescriber not cooperate, the CMS approach gives the plan the power to put such beneficiary-level claim edits in place to protect the patient's safety.
7) Some sort of case management activity is necessary to ensure future compliance.
Solid start.
How does this compare with your organization's approach?
Michael
On Twitter @PRIUM1
Tuesday, July 10, 2012
FDA Plan on Opioids: Good News? Or Bad?
Today brought a tale of two headlines. Business Insurance declared "FDA Approves Plan to Fight Growing Opioid Abuse" while the New York Times declared "FDA Won't Order Doctors to Get Pain-Drug Training." Turns out, they're both right.
The FDA on Monday adopted the Risk Evaluation and Mitigation Strategy that has been debated, discussed, and deliberated for several years. The plan requires manufacturers of prescription opioids to, among other things, create and distribute physician and patient educational materials. That's not exactly a solution unto itself, but it does represent progress (and at least tacit acknowledgment on the part of the pharmaceutical industry that the misuse and abuse of prescription painkillers has become a national health crisis).
The controversial nature of the FDA announcement is driven largely by what is absent from the plan - mandatory physician training on the topic of safe opioid prescribing. In 2010, the FDA's own advisory panel rejected the notion that this plan should include "voluntary physician education," instead recommending that the such education should be mandatory. But the FDA has chosen to punt to Congress on this issue. The NY Times indicates that the FDA commissioner is "hopeful that Congress would eventually enact mandatory physician training."
In principle, I think this position is dangerous and not in keeping with the severity of the issue we face as a society. Pragmatically, however, I'm not certain the FDA has the authority (or perhaps more importantly, the enforcement capabilities) to create rules around mandatory physician education.
State medical boards and/or (I can't believe I'm writing this...) the US Congress need to step in and create both the mandate for physician training around opioid prescribing as well as the consequences for non-participation. This is more complicated than it might seem, but certainly a policy step necessary to stem the tide of opioid misuse and abuse.
Michael
On Twitter @PRIUM1
The FDA on Monday adopted the Risk Evaluation and Mitigation Strategy that has been debated, discussed, and deliberated for several years. The plan requires manufacturers of prescription opioids to, among other things, create and distribute physician and patient educational materials. That's not exactly a solution unto itself, but it does represent progress (and at least tacit acknowledgment on the part of the pharmaceutical industry that the misuse and abuse of prescription painkillers has become a national health crisis).
The controversial nature of the FDA announcement is driven largely by what is absent from the plan - mandatory physician training on the topic of safe opioid prescribing. In 2010, the FDA's own advisory panel rejected the notion that this plan should include "voluntary physician education," instead recommending that the such education should be mandatory. But the FDA has chosen to punt to Congress on this issue. The NY Times indicates that the FDA commissioner is "hopeful that Congress would eventually enact mandatory physician training."
In principle, I think this position is dangerous and not in keeping with the severity of the issue we face as a society. Pragmatically, however, I'm not certain the FDA has the authority (or perhaps more importantly, the enforcement capabilities) to create rules around mandatory physician education.
State medical boards and/or (I can't believe I'm writing this...) the US Congress need to step in and create both the mandate for physician training around opioid prescribing as well as the consequences for non-participation. This is more complicated than it might seem, but certainly a policy step necessary to stem the tide of opioid misuse and abuse.
Michael
On Twitter @PRIUM1
Monday, July 9, 2012
Connecticut Gets Drug Repackaging Right: Removing the Financial Incentive
I just reviewed the proposed language for Connecticut's rule change on repackaged drugs. Excellent piece of regulatory work, specifically because it includes all of the elements of an effective approach to mitigating the issue (and a road map for other states to follow):
1) The rule doesn't ban physician dispensing. There are legitimate reasons a doctor may need to dispense medications to a patient and this rule allows for those limited circumstances.
2) The rule focuses on the financial remuneration tied to physician dispensing and fixes such fees at the Average Wholesale Price (AWP) of the medication plus a reasonable dispensing fee ($5 for brand and $8 for generics).
3) The rule clearly specifies the source for the AWP (Medi-Span). Many states are silent to the AWP source and this creates a lot of noise in the system.
4) The rule specifies that fees are determined by "a) the NDC for the underlying drug product from the original manufacturer, or b) the therapeutic equivalent drug product from the original manufacturer/labeler NDC." This leaves no room for physicians or other agents to create new NDC codes as a result of repackaging.
5) If the underlying NDC isn't known or isn't shared, discretion rests with the payer to determine the most appropriate NDC code. There is a dispute resolution process outlined if the provider disagrees.
6) Perhaps most importantly, this is a regulatory change, not a statutory change. The laws of the state of CT allow the Work Comp Commission Chairman John Mastropietro to enact this rule change without legislative approval. This won't be possible in all states, but where it is, it's the way to go.
These are the five (and six, where possible) central tenants of an effective regulatory approach to repackaged drugs. Hopefully, we'll see this loophole closed state by state as soon as possible.
Michael
On Twitter @PRIUM1
1) The rule doesn't ban physician dispensing. There are legitimate reasons a doctor may need to dispense medications to a patient and this rule allows for those limited circumstances.
2) The rule focuses on the financial remuneration tied to physician dispensing and fixes such fees at the Average Wholesale Price (AWP) of the medication plus a reasonable dispensing fee ($5 for brand and $8 for generics).
3) The rule clearly specifies the source for the AWP (Medi-Span). Many states are silent to the AWP source and this creates a lot of noise in the system.
4) The rule specifies that fees are determined by "a) the NDC for the underlying drug product from the original manufacturer, or b) the therapeutic equivalent drug product from the original manufacturer/labeler NDC." This leaves no room for physicians or other agents to create new NDC codes as a result of repackaging.
5) If the underlying NDC isn't known or isn't shared, discretion rests with the payer to determine the most appropriate NDC code. There is a dispute resolution process outlined if the provider disagrees.
6) Perhaps most importantly, this is a regulatory change, not a statutory change. The laws of the state of CT allow the Work Comp Commission Chairman John Mastropietro to enact this rule change without legislative approval. This won't be possible in all states, but where it is, it's the way to go.
These are the five (and six, where possible) central tenants of an effective regulatory approach to repackaged drugs. Hopefully, we'll see this loophole closed state by state as soon as possible.
Michael
On Twitter @PRIUM1
Thursday, July 5, 2012
Purdue and GSK: Unintentional Irony in the Wall Street Journal
I'm still a little upset about the path Purdue Pharma is taking to extend patent exclusivity for Oxycontin for six additional months: testing in kids. The same day this hit the news (Tuesday), it was also reported that GlaxoSmithKline had agreed to plead guilty to charges of illegally marketing drugs and intentionally withholding safety data from US regulators.
Pages B2 and B3 of Tuesday's WSJ contain the two stories, virtually side by side. Excerpts from both:
B3: "Purdue hopes to gain six extra months next year of patent protection for Oxycontin by testing whether the powerful painkiller is safe for children."
B2: "The Justice Department says GSK improperly promoted some of its drugs from 1999 through 2010 for off-label uses. [One highlight from the government complaint]: Marketing Paxil, an antidepressant, as safe for children, despite trials that raised concerns about suicide. Example: Gave free samples to child psychiatrists."
Despite assurances from Purdue that the company doesn't promote the use of Oxycontin for children, I found the juxtaposition of these two stories both troubling and ironic.
Michael
On Twitter @PRIUM1
Pages B2 and B3 of Tuesday's WSJ contain the two stories, virtually side by side. Excerpts from both:
B3: "Purdue hopes to gain six extra months next year of patent protection for Oxycontin by testing whether the powerful painkiller is safe for children."
B2: "The Justice Department says GSK improperly promoted some of its drugs from 1999 through 2010 for off-label uses. [One highlight from the government complaint]: Marketing Paxil, an antidepressant, as safe for children, despite trials that raised concerns about suicide. Example: Gave free samples to child psychiatrists."
Despite assurances from Purdue that the company doesn't promote the use of Oxycontin for children, I found the juxtaposition of these two stories both troubling and ironic.
Michael
On Twitter @PRIUM1
Tuesday, July 3, 2012
Purdue Crosses the Line: Leave the Kids Alone
Front page of the Wall Street Journal this morning: "Purdue Pharma hopes to gain
six months of extra patent protection for OxyContin by testing whether the pain
killer is safe for children."
As I flipped to the article, I thought "this must be for terminally ill kids... because as sad as that would be, there's no way, in good conscience, they could test this stuff on kids otherwise."
I was wrong. The study will include subjects ages 6 to 16 in "moderate to severe pain." Purdue is attempting to take advantage of an FDA rule that allows for the extension of patent exclusivity merely for conducting studies in pediatric populations. The goal of the incentive is to help pediatric specialists understand the effect of a wide range of medications on children (which sounds like a good idea). In this case, Purdue is exploiting the FDA reg in order to rack up another $1 billion before OxyContin goes generic. It's despicable.
The very nature of FDA trials are short-term. The real danger here is the long term effects on the children that participate in the study (about 150 children will be included). What impact might this have on the future risk of addiction to opioids or other addictive substances? How will Purdue know? Are there requirements to track these kids as they grow into adulthood? Is the risk here really worth the "benefit," which will largely accrue to a pharmaceutical company in the form of additional revenues?
True, pediatric specialists will have more data on the drug's safety and efficacy profile in children... but so what? While we grapple, as a society, with the unintended consequences of opioid misuse - a problem the CDC has rightly labeled an "epidemic" - let's leave the kids out of it. Please.
Michael
On Twitter @PRIUM1
As I flipped to the article, I thought "this must be for terminally ill kids... because as sad as that would be, there's no way, in good conscience, they could test this stuff on kids otherwise."
I was wrong. The study will include subjects ages 6 to 16 in "moderate to severe pain." Purdue is attempting to take advantage of an FDA rule that allows for the extension of patent exclusivity merely for conducting studies in pediatric populations. The goal of the incentive is to help pediatric specialists understand the effect of a wide range of medications on children (which sounds like a good idea). In this case, Purdue is exploiting the FDA reg in order to rack up another $1 billion before OxyContin goes generic. It's despicable.
The very nature of FDA trials are short-term. The real danger here is the long term effects on the children that participate in the study (about 150 children will be included). What impact might this have on the future risk of addiction to opioids or other addictive substances? How will Purdue know? Are there requirements to track these kids as they grow into adulthood? Is the risk here really worth the "benefit," which will largely accrue to a pharmaceutical company in the form of additional revenues?
True, pediatric specialists will have more data on the drug's safety and efficacy profile in children... but so what? While we grapple, as a society, with the unintended consequences of opioid misuse - a problem the CDC has rightly labeled an "epidemic" - let's leave the kids out of it. Please.
Michael
On Twitter @PRIUM1
Monday, July 2, 2012
MMI and Narcotics: Can't Get There From Here
For those of you with access to the American Medical Association's "Guides Newsletter", check out the March/April 2011 issue. There's a great article entitled Prescription Narcotics: An Obstacle to Maximum Medical Improvement. (I'm actually not that behind in my reading... I was just given a copy of this particular article recently).
The article points out that there are "concerns that the obstables to MMI created by prescription narcotics will delay the resolution of claims (which could be harmful to the patient, as well as to other stakeholders). There is also concern that evaluators will confuse the effects of narcotics with permanent impairment and will consequently create erroneous impairment ratings."
The basic premise here is that narcotics expand the nature of a patient's impairment beyond pain. When one is on narcotics for a long period of time, MMI becomes nearly impossible to assess with any degree of accuracy.
We're starting to see some physicians justify chronic opioid therapy and refuse to respond to the evidence because "the patient is at MMI."
Challenge this presumption. It will benefit you and your claimant when you do.
Michael
On Twitter @PRIUM1
The article points out that there are "concerns that the obstables to MMI created by prescription narcotics will delay the resolution of claims (which could be harmful to the patient, as well as to other stakeholders). There is also concern that evaluators will confuse the effects of narcotics with permanent impairment and will consequently create erroneous impairment ratings."
The basic premise here is that narcotics expand the nature of a patient's impairment beyond pain. When one is on narcotics for a long period of time, MMI becomes nearly impossible to assess with any degree of accuracy.
We're starting to see some physicians justify chronic opioid therapy and refuse to respond to the evidence because "the patient is at MMI."
Challenge this presumption. It will benefit you and your claimant when you do.
Michael
On Twitter @PRIUM1
Thursday, June 28, 2012
Reducing Opioid Utilization: Feedback on IAIABC Model Legislation and Rules
[Submitted to IAIABC on June 28, 2012]
To Whom it May Concern:
On behalf of PRIUM, a URAC-accredited utilization review
company based in Duluth, GA, I’d like to commend the IAIABC on its efforts to
address the epidemic of prescription drug over-utilization in workers’ compensation
systems throughout the country. We have reviewed both the model statutory
language as well as the model regulatory language IAIABC developed and would
like to provide the following comments:
Regarding the model legislation, the critical components of
any state effort to stem the tide of prescription drug misuse appear to be
present. Treatment guidelines, PDMPs, dosage and duration limitations,
pre-authorization, appropriate billing for services, and dispute resolution
are, in fact, the essential elements of an effective statutory strategy to
address the issue. We see room for improvement, however, in the model
statutory language in two areas:
1) [Section
2: Treatment guidelines]: The current language leaves far too much latitude for
states to develop consensus-based guidelines (vs. evidence-based
guidelines). We recognize the use of the term “evidence based” in the
model language, but left open to the whims of state politics, medical boards,
and lobbying efforts from the pharmaceutical and medical device industries, a
state might be left with relatively weak, ineffectual medical treatment
guidelines that allow status quo prescribing patterns to continue
unabated. As an alternative, we suggest one of two approaches:
a.
Define the treatment guidelines to be adopted
within the statutory language itself (as opposed to leaving it to the state
agency to determine); or
b.
Provide a more thorough definition of
appropriate medical treatment guidelines, perhaps through a series of criteria
that must be met. Such criteria might include requirements that the
medical treatment guidelines:
i.
Rely on specified, comprehensive, systematic
review of medical literature;
ii.
Include transparent criteria for rating the
strength of evidence, including individual medical studies;
iii.
Remain current and incorporate contemporary
studies;
iv.
Address frequency, duration, intensity, and
appropriateness of treatment;
v.
Have been adopted by at least one other state.
2) [Section
6: Prohibition]: The use of the word “may” in connection with preauthorization
is troubling. In some states, the preauthorization process is viewed by
physicians as contentious and antagonistic. PRIUM advocates the use of
preauthorization procedures if, and only if, the treating physician refuses to
engage in collegial discussion or respond to the medical evidence when it is
presented to him/her by a peer. Nevertheless, should a treating physician
prove unresponsive to the evidence, we believe statutory language should
provide more stringent protocols for addressing such issues. We also find
the limit in Section 6 to “specific forms of opioids” far too narrow to address
the overarching issue the industry currently faces. We suggest the
following: “The Agency shall grant the insurance carrier the right to require
preauthorization for any medications being prescribed that do not appear to
meet the standard of care established by the medical treatment
guidelines.”
Regarding the model rules, the translation from statute to
regulatory approach is well defined. We found the “drafting notes” to be
particularly helpful in guiding lawmakers in the development of these critical
rules. There are a few areas, however, that we believe require more
nuanced thinking prior to launching the regulatory model:
1) [Section
1, (3): Effective Date]: Our industry learned a valuable lesson from the
creation, adoption, and implementation of the Texas Closed Formulary
Rules. Texas implemented these new rules in two stages: starting 9/1/11
for all new injuries as of that date, and starting 9/1/13 for all “legacy”
claims, effectively providing a two year remediation period for the insurance
carriers and treating physicians to address difficult cases in preparation for
the 9/1/13 requirement for preauthorization of all N drugs. This is smart
public policy. Contrast this with New York where adoption of medical
treatment guidelines as of a single, “line in the sand” effective date has
created a judicial and legislative battle that has yet to resolve itself.
On the one hand, a single effective date creates chaos as carriers and
physicians try to figure out how to address legacy claims, which tend to be
extremely complicated. On the other hand, only applying new rules to new
injuries creates two standards of care within a workers’ compensation system, where
an injured worker’s treatment plan is driven entirely by the date on which they
were injured (which makes no clinical sense). We recommend model
regulatory language that mirrors the Texas Closed Formulary approach – an
initial implementation date for new injuries, followed by a remediation period
for legacy claims, followed by a fully effective date for new rules and all
claims.
2) [Section
7: Continuing Education]: We understand that there was a lively discussion on
your most recent conference call regarding the mandated education component of
the model rules. Our view is that the absolute onslaught of marketing
dollars spent by the pharmaceutical industry to “educate” doctors should, in
fact must, be countered by mandated, unbiased continuing education focused on
the risks associated with chronic opioid therapy. In 2011, the
pharmaceutical industry generated $11 billion from the sale of opioids, a full
$3 billion just from Oxycontin. The #1 source of information for
physicians regarding these drugs remains the drug company sales
representative. This must change. PRIUM is disappointed that state
medical societies and the American Medical Association are opposed to such
measures. We strongly recommend that IAIABC remain committed to mandated
continuing education.
3) [Section
10, Preauthorization Required]: PRIUM believes that the best possible way to
eliminate the over-utilization of prescription drugs in workers’ compensation
is to engage the treating physician in the creation of a revised treatment plan.
Mandated preauthorization should not be the first step taken by an insurance
carrier when a particular claim is brought under scrutiny due to the
prescription medication regimen. That being said, if the treating
physician refuses to participate in the creation of a revised treatment plan
and continues to prescribe, in some cases, dangerous levels of medications,
mandated preauthorization can be a powerful tool to protect patient safety and
ensure positive clinical outcomes.
We appreciate the opportunity to provide this feedback and
commend IAIABC for the transparency and collaboration that have been emblematic
of this process thus far.
Respectfully submitted,
Michael Gavin
Chief Strategy Officer
PRIUM
Michael Gavin - Chief
Strategy Officer
2805 Peachtree Industrial Blvd.
Suite 112
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Friday, June 22, 2012
Joe Paduda Hosts Health Wonk Review
Thanks for including Evidence Based!
http://www.joepaduda.com/archives/002358.html
On Twitter @PRIUM1
http://www.joepaduda.com/archives/002358.html
On Twitter @PRIUM1
Wednesday, June 20, 2012
The Medical/Legal Summit: Why Isn't Everyone Doing This?
I was privileged last week to spend a few days in Charlotte, NC with Arrowpoint Capital. Julie Fortune, Chief Claims Officer, and her team put together a Medical/Legal Summit in hopes of educating, coordinating, and enhancing the medical management and litigation management of their claims. They pulled together about 120 people including internal claims adjusters, litigation managers, outside vendors, outside legal counsel (from many different jurisdictions), medical experts, and even invited an Arrowpoint actuary (all joking aside, Rich gave a great presentation on the importance of historical cost data to actuaries).
Topics focused on chronic pain management, appropriate use of prescription drug therapy, alternative treatment pathways, Medicare and secondary payment rules, case management, proper use of investigative services, changing rules and regulations at the state level, and how best to use clinical resources like doctors, nurses, and pharmacists.
And this wasn't summer camp, folks. This was an intense conference that started promptly at 8:00 am each morning and lasted well into the night as attendees worked on a rather complicated case study. The Arrowpoint leadership team divided their employees and all of the outside attorneys into eight case teams and had each team present at the end of the conference, incorporating all that they had learned during the course of the conference. And everyone had to present. No free riders. You had to pay attention and really show that you "got it".
Arrowpoint is managing run-off claims, but every payer has a subset of claims that require high levels of coordination amongst many parties, internally and externally, in order to achieve positive outcomes (clinically and legally). And one of my key take-aways from the Summit is how closely those two strategies - clinical and legal - need to be linked.
Does your organization pull together an annual Medical/Legal Summit? If not, why not? This is the sort of education and coordination our industry needs.
Let's get to work.
Michael
On Twitter @PRIUM1
Topics focused on chronic pain management, appropriate use of prescription drug therapy, alternative treatment pathways, Medicare and secondary payment rules, case management, proper use of investigative services, changing rules and regulations at the state level, and how best to use clinical resources like doctors, nurses, and pharmacists.
And this wasn't summer camp, folks. This was an intense conference that started promptly at 8:00 am each morning and lasted well into the night as attendees worked on a rather complicated case study. The Arrowpoint leadership team divided their employees and all of the outside attorneys into eight case teams and had each team present at the end of the conference, incorporating all that they had learned during the course of the conference. And everyone had to present. No free riders. You had to pay attention and really show that you "got it".
Arrowpoint is managing run-off claims, but every payer has a subset of claims that require high levels of coordination amongst many parties, internally and externally, in order to achieve positive outcomes (clinically and legally). And one of my key take-aways from the Summit is how closely those two strategies - clinical and legal - need to be linked.
Does your organization pull together an annual Medical/Legal Summit? If not, why not? This is the sort of education and coordination our industry needs.
Let's get to work.
Michael
On Twitter @PRIUM1
Monday, June 18, 2012
PDMPs: NY Sets the Standard, MO Lags Behind
Prescription Drug Monitoring Programs (PDMPs) are an essential tool for combatting the inappropriate use of prescription drugs. New York has put in place legislation that may serve as a model for how best to design and implement such a program.
The bill calls for mandatory electronic communication of prescriptions between doctors and pharmacies within three years, real time tracking of prescriptions, and required record checks before doctors write new scripts for certain medications, including opioids.
Of course, state level efforts can only have so much impact. Doctor shopping across borders is becoming increasingly common and right now, no single database contains sufficient information to help prevent inappropriate prescriptions on an interstate basis. I understand there is some nascent movement toward establishing such a database, but my quick research didn't yield anything substantial.
And congrats to New Hampshire for finally getting its act together. NH is the 49th state to establish a PDMP program. The "Live Free of Die" crowd certainly fought against it, even winning a provision that data would be deleted after 6 months (unless abuse is expected). We'll take what we can get.
The lone hold out? Missouri. The "Show Me" state needs to show us they're serious about prescription drug abuse. Might be an uphill battle, though. Here's a quote from Missouri State Senator Rob Shaaf (R-St. Joseph), a family physician, after the passage of a PDMP bill in March of this year (which appears to have stalled in committee back in May): "Letting the government have your very personal and sensitive medical information on a government database, it's just wrong and Big Brother shouldn't have that effect on our lives... this is liberty versus safety."
Yeah... drug addicts should be free to doctor shop as much as they wish without fear of detection or consequence. And drug seekers throughout the midwest should feel equally free to flood into Missouri seeking prescription drugs. Not exactly enlightened public policy, but so what if the preservation of liberty makes Missouri the nation's capital for prescription drug abuse?
Liberty has its bounds, Dr. Schaaf, and you're on the wrong side of this one.
Michael
On Twitter @PRIUM1
The bill calls for mandatory electronic communication of prescriptions between doctors and pharmacies within three years, real time tracking of prescriptions, and required record checks before doctors write new scripts for certain medications, including opioids.
Of course, state level efforts can only have so much impact. Doctor shopping across borders is becoming increasingly common and right now, no single database contains sufficient information to help prevent inappropriate prescriptions on an interstate basis. I understand there is some nascent movement toward establishing such a database, but my quick research didn't yield anything substantial.
And congrats to New Hampshire for finally getting its act together. NH is the 49th state to establish a PDMP program. The "Live Free of Die" crowd certainly fought against it, even winning a provision that data would be deleted after 6 months (unless abuse is expected). We'll take what we can get.
The lone hold out? Missouri. The "Show Me" state needs to show us they're serious about prescription drug abuse. Might be an uphill battle, though. Here's a quote from Missouri State Senator Rob Shaaf (R-St. Joseph), a family physician, after the passage of a PDMP bill in March of this year (which appears to have stalled in committee back in May): "Letting the government have your very personal and sensitive medical information on a government database, it's just wrong and Big Brother shouldn't have that effect on our lives... this is liberty versus safety."
Yeah... drug addicts should be free to doctor shop as much as they wish without fear of detection or consequence. And drug seekers throughout the midwest should feel equally free to flood into Missouri seeking prescription drugs. Not exactly enlightened public policy, but so what if the preservation of liberty makes Missouri the nation's capital for prescription drug abuse?
Liberty has its bounds, Dr. Schaaf, and you're on the wrong side of this one.
Michael
On Twitter @PRIUM1
Wednesday, June 13, 2012
The Battle Over Hydrocodone: Revisited
This blog, first and foremost, is intended to be informative and educational. My goal has always been to cast about with opinions and the allow others to offer feedback, guidance, and perspective.
Such has been the case since I advocated for moving hydrocodone-containing medications from schedule III to schedule II. On Monday, I wrote about the controversy regarding a provision drafted by Sen. Joe Manchin (D - WV) that would provide for such a reclassification.
In response to that post, I heard from several pharmacists that disagreed with my position.
First, it was pointed out that hydrocodone-acetaminophen is an acute medication and changing it to a schedule II drug may inhibit access to patients that need it quickly. I pointed out that data suggests the drug is often used for chronic pain management, too. That brought this response from a pharmacist: "Hydrocodone is often used chronically, although it is often for breakthrough pain and often with a long acting opioid. Hydrocodone/APAP would not be the sole pain medication. Data from a large carrier in Q4 2011 shows 14% of mature patients using hydrocodone (3 years or older) are using it with a long acting opioid."
Another issue, perhaps more relevant to the battle over abuse and addiction of prescription drugs: "Reclassifying hydrocodone/apap products as a CII does not address the inappropriate and over prescribing of this medication and opioids in general. All it will do is create undue burden on pharmacists and patients without addressing the real problem. Physicians generally do not care how much work or regulatory hoops pharmacists have to jump through to fill a prescription." Good point.
What we all decided to agree upon, though, is the fact that Zohydro (a single ingredient hydrocodone drug as a controlled release long acting opioid - currently pending FDA approval) should be a schedule II drug.
Thanks to all for the input.
Michael
On Twitter @PRIUM1
Such has been the case since I advocated for moving hydrocodone-containing medications from schedule III to schedule II. On Monday, I wrote about the controversy regarding a provision drafted by Sen. Joe Manchin (D - WV) that would provide for such a reclassification.
In response to that post, I heard from several pharmacists that disagreed with my position.
First, it was pointed out that hydrocodone-acetaminophen is an acute medication and changing it to a schedule II drug may inhibit access to patients that need it quickly. I pointed out that data suggests the drug is often used for chronic pain management, too. That brought this response from a pharmacist: "Hydrocodone is often used chronically, although it is often for breakthrough pain and often with a long acting opioid. Hydrocodone/APAP would not be the sole pain medication. Data from a large carrier in Q4 2011 shows 14% of mature patients using hydrocodone (3 years or older) are using it with a long acting opioid."
Another issue, perhaps more relevant to the battle over abuse and addiction of prescription drugs: "Reclassifying hydrocodone/apap products as a CII does not address the inappropriate and over prescribing of this medication and opioids in general. All it will do is create undue burden on pharmacists and patients without addressing the real problem. Physicians generally do not care how much work or regulatory hoops pharmacists have to jump through to fill a prescription." Good point.
What we all decided to agree upon, though, is the fact that Zohydro (a single ingredient hydrocodone drug as a controlled release long acting opioid - currently pending FDA approval) should be a schedule II drug.
Thanks to all for the input.
Michael
On Twitter @PRIUM1
Tuesday, June 12, 2012
BCBS of Mass: Tough New Policy on Opioid Scripts
Blue Cross Blue Shield of Massachusetts is deploying a new policy regarding opioid scripts beginning on July 1. Physicians will be restricted from writing more than a 30 days supply of powerful painkillers without a mandatory review by BCBS.
This is a "first of its kind" policy in commercial/group health (as far as I can tell), though the concept isn't foreign to us in work comp. The issue of prescription drug abuse is pervasive and I'm pleased to see BCBS of MA take this bold step.
Yes, this is going to create some additional administrative burden and expense for physicians. Those concerns are legitimate. Unfortunately, the societal cost of abuse and addiction are sufficiently high that policies such as this are necessary.
Michael
On Twitter @PRIUM1
This is a "first of its kind" policy in commercial/group health (as far as I can tell), though the concept isn't foreign to us in work comp. The issue of prescription drug abuse is pervasive and I'm pleased to see BCBS of MA take this bold step.
Yes, this is going to create some additional administrative burden and expense for physicians. Those concerns are legitimate. Unfortunately, the societal cost of abuse and addiction are sufficiently high that policies such as this are necessary.
Michael
On Twitter @PRIUM1
Monday, June 11, 2012
The Battle Over Hydrocodone: Pharmacists Take a Surprising Stand
US Senator Joe Manchin (D - WV) has authored a piece of legislation that would reschedule hydrocodone from schedule III to schedule II (via an amendment to the Prescription Drug User Fee Act). This sounds simple enough and enjoys bipartisan support on the Hill.
1) Most claims people (and even many clinical people) think hydrocodone is already a schedule II drug.
2) There's no doubt that hydrocone-containing products are dangerous, come with significant risk of addiction, and should be better controlled than they currently are.
3) This represents an opportunity for politicians and regulators to show that they're at least willing to take some easy steps to stem the tide of prescription drug over-utilization and abuse in this country.
You would think, at least.
A letter was sent last week to all members of the House and Senate from five aligned groups that have two things in common: first, they are either made up of or represent pharmacists; and second, they don't want to see this bill pass. The groups? The American Pharmacists Association, Food Marketing Institute, International Academy of Compounding Pharmacists (really?), National Association of Chain Drug Stores, and National Pharmacists Association.
The letter states, in part:
“We understand the concerns about diversion and abuse of these products and we share these concerns. Nevertheless, moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products, and it will result in adding to the nation’s healthcare costs with no assurance of a reduction in diversion and abuse.”
That is absolutely wrong headed.
What are the practical implications of moving hydrocodone products to schedule II?
- They can't be prescribed as easily physicians and some states restrict NPs and PAs from precribing schedule II drugs at all.
- The drugs will become more costly for pharmacies to obtain and inventory will become more expensive to manage (given the stringent storage and inventory assessment requirements).
Making hydrocodone harder to obtain WILL NOT impact patients that truly need the drugs. The real issue here is that pharmacy margins, already thin, are going to take a hit. I acknowledge this is a real economic issue and an unfortunate unintended consequence of doing the right thing.
Michael
On Twitter @PRIUM1
1) Most claims people (and even many clinical people) think hydrocodone is already a schedule II drug.
2) There's no doubt that hydrocone-containing products are dangerous, come with significant risk of addiction, and should be better controlled than they currently are.
3) This represents an opportunity for politicians and regulators to show that they're at least willing to take some easy steps to stem the tide of prescription drug over-utilization and abuse in this country.
You would think, at least.
A letter was sent last week to all members of the House and Senate from five aligned groups that have two things in common: first, they are either made up of or represent pharmacists; and second, they don't want to see this bill pass. The groups? The American Pharmacists Association, Food Marketing Institute, International Academy of Compounding Pharmacists (really?), National Association of Chain Drug Stores, and National Pharmacists Association.
The letter states, in part:
“We understand the concerns about diversion and abuse of these products and we share these concerns. Nevertheless, moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products, and it will result in adding to the nation’s healthcare costs with no assurance of a reduction in diversion and abuse.”
That is absolutely wrong headed.
What are the practical implications of moving hydrocodone products to schedule II?
- They can't be prescribed as easily physicians and some states restrict NPs and PAs from precribing schedule II drugs at all.
- The drugs will become more costly for pharmacies to obtain and inventory will become more expensive to manage (given the stringent storage and inventory assessment requirements).
Making hydrocodone harder to obtain WILL NOT impact patients that truly need the drugs. The real issue here is that pharmacy margins, already thin, are going to take a hit. I acknowledge this is a real economic issue and an unfortunate unintended consequence of doing the right thing.
Michael
On Twitter @PRIUM1
Thursday, June 7, 2012
New Health Wonk Review
Check it out. Thanks to Maggie Mahar for including Evidence Based.
http://www.healthinsurance.org/blog/2012/06/07/health-wonk-review/
On Twitter @PRIUM1
http://www.healthinsurance.org/blog/2012/06/07/health-wonk-review/
On Twitter @PRIUM1
Wednesday, June 6, 2012
NCCI Narcotics Report: The More You Get... The More You Get
Of all the interesting statistics contained in the new NCCI research brief, the one that stood out most to me was the section entitled "Early Narcotic Use Is Indicative of Prolonged Use." Turns out, the earlier one gets narcotics and the higher the dose one receives... the longer one will likely be on the drugs and the higher the dose will likely be.
If ever there was an analysis that supported early intervention on claims where narcotics are being utilized, this is it. Most of us have felt this intuitively, but this is the first analysis I've seen detailing the extent of the issue.
Some highlights:
- Shockingly, about 10% of claimants receive > 825 mg MED in the first quarter following injury. 50% of all claims receive between 100 mg MED and 370 mg MED in the first quarter following injury. Recall the 120 mg MED threshold from my post earlier this week. That's a monthly metric, not quarterly... but I was still surprised at the prevalence of high doses of narcotics early in the claim life.
- 63% of claimants with MED > 825 mg in the initial quarter following injury continued to receive narcotics in the second quarter following injury. Only 35% of claimants receiving between 370 mg and 825 mg MED in the first quarter post-injury continue to receive narcotics in the next quarter.
- The graphics NCCI put together on this topic are compelling. Check out Exhibits 8 and 9. Once a claimant is on high doses of narcotics, that claimant is highly likely to remain on high doses of the drugs. For the 10% of claimants that start out on > 825 mg MED, the average MED in the first quarter post-injury appears to be in the range of 2,000 mg MED (or approximately 650-700 mg MED per month). By the 20th quarter post injury, this cohort averages around 7,000 mg MED (or over 2,000 mg MED per month).
This is unfathomable. And it begs the obvious question for further analysis: What is the death rate, by quarter, in the > 825 mg MED cohort?
Michael
On Twitter @PRIUM1
If ever there was an analysis that supported early intervention on claims where narcotics are being utilized, this is it. Most of us have felt this intuitively, but this is the first analysis I've seen detailing the extent of the issue.
Some highlights:
- Shockingly, about 10% of claimants receive > 825 mg MED in the first quarter following injury. 50% of all claims receive between 100 mg MED and 370 mg MED in the first quarter following injury. Recall the 120 mg MED threshold from my post earlier this week. That's a monthly metric, not quarterly... but I was still surprised at the prevalence of high doses of narcotics early in the claim life.
- 63% of claimants with MED > 825 mg in the initial quarter following injury continued to receive narcotics in the second quarter following injury. Only 35% of claimants receiving between 370 mg and 825 mg MED in the first quarter post-injury continue to receive narcotics in the next quarter.
- The graphics NCCI put together on this topic are compelling. Check out Exhibits 8 and 9. Once a claimant is on high doses of narcotics, that claimant is highly likely to remain on high doses of the drugs. For the 10% of claimants that start out on > 825 mg MED, the average MED in the first quarter post-injury appears to be in the range of 2,000 mg MED (or approximately 650-700 mg MED per month). By the 20th quarter post injury, this cohort averages around 7,000 mg MED (or over 2,000 mg MED per month).
This is unfathomable. And it begs the obvious question for further analysis: What is the death rate, by quarter, in the > 825 mg MED cohort?
Michael
On Twitter @PRIUM1
Tuesday, June 5, 2012
Lousiana HB 126: Poor Guidelines and Covering Tracks
I've been tracking things in Louisiana over the last several weeks. I'll be down in Baton Rouge in about 10 days to talk about prescription drug abuse and what can be done about it...
In the course of my preparation, however, I've come across a very disturbing confluence of events that deserves a bit more attention than its getting.
Back in 2009, the Louisiana state legislature did an enlightened thing and instructed the Office of Workers' Compensation (OWC) to adopt medical treatment guidelines that met very specific criteria, including reliance on systematic medical literature review, published criteria for rating studies and strength of medical evidence, use of contemporary studies, and evidence of adoption by at least one other state - in short, evidence-based guidelines.
Long story short - the OWC appointed a Medical Advisory Council to evaluate guidelines and recommend which should be chosen. The OWC/MAC promptly ignored the statutory mandate and began a rather obvious and pronounced drift toward consensus-based guidelines.
I couldn't get anyone to go "on the record" for me regarding the the undue influence of outside stakeholders, but suffice it say that it appears likely that the pharmaceutical and/or medical device industry could have had significant input on the guidelines through the MAC.
And then it gets worse...
Herbert Dixon (D - Alexendria) and Chris Broadwater (R - District 86) of the Louisiana State House of Representatives have sheperded a bill through the legislature and onto the governor's desk (HB 126 can be found here) that completely absolves members of the Work Comp Advisory Committee and Medical Advisory Committee of any accountability whatsoever regarding their work. Specifically, the bill states that members of these committees "shall not be subject to civil or administrative subpoena for his recommendations or exercise of judgment as a member of the council, including subpoena seeking his oral or written testimony at trial, discovery, or other proceeding, and a subpoena duces tecum seeking documents, inspections, things or information in electronic or any other form."
Leaving aside the clear overstep of legislative authority (is this even constitutional?), let's just focus on the what this means: A doctor in Louisiana can accept an appointment to the Medical Advisory Committee, do the bidding of the pharmaceutical and medical device industries, develop guidelines that absolutely do NOT adhere to the legislative mandate of SB303, leave the state work comp system in worse shape than it was already in... and all records, emails, transcripts, etc. connected to their work can be hidden from the light of day and they can never be called to testify in any forum to defend their judgment?
I spoke to both Dixon and Broadwater. Broadwater told me that the intent of HB 126 is to protect voluntary participation on the part of medical experts on such committees from inappropriate harassment. Further, his position is that the rule-making process, public comment period, and ongoing opportunity to amend the medical treatment guidelines provide sufficient transparency in the system that knowing exactly who is influencing the MAC isn't relevant.
I respectfully disagree. If these people really are the "experts," I want assurances that their judgment, their expertise, and their counsel isn't being clouded by drug and device manufacturers. Let's be realistic: the MAC may not have any rule making authority at all, but their advice (as experts) defines the default rules for public consideration. How do we know we're starting off on the right foot?
So, to sum up...
Dear Governor Jindal,
Don't sign this bill into law.
Sincerely,
All of us out here who think responsibility and accountability are fundamental tenets of government.
Michael
On Twitter @PRIUM1
In the course of my preparation, however, I've come across a very disturbing confluence of events that deserves a bit more attention than its getting.
Back in 2009, the Louisiana state legislature did an enlightened thing and instructed the Office of Workers' Compensation (OWC) to adopt medical treatment guidelines that met very specific criteria, including reliance on systematic medical literature review, published criteria for rating studies and strength of medical evidence, use of contemporary studies, and evidence of adoption by at least one other state - in short, evidence-based guidelines.
Long story short - the OWC appointed a Medical Advisory Council to evaluate guidelines and recommend which should be chosen. The OWC/MAC promptly ignored the statutory mandate and began a rather obvious and pronounced drift toward consensus-based guidelines.
I couldn't get anyone to go "on the record" for me regarding the the undue influence of outside stakeholders, but suffice it say that it appears likely that the pharmaceutical and/or medical device industry could have had significant input on the guidelines through the MAC.
And then it gets worse...
Herbert Dixon (D - Alexendria) and Chris Broadwater (R - District 86) of the Louisiana State House of Representatives have sheperded a bill through the legislature and onto the governor's desk (HB 126 can be found here) that completely absolves members of the Work Comp Advisory Committee and Medical Advisory Committee of any accountability whatsoever regarding their work. Specifically, the bill states that members of these committees "shall not be subject to civil or administrative subpoena for his recommendations or exercise of judgment as a member of the council, including subpoena seeking his oral or written testimony at trial, discovery, or other proceeding, and a subpoena duces tecum seeking documents, inspections, things or information in electronic or any other form."
Leaving aside the clear overstep of legislative authority (is this even constitutional?), let's just focus on the what this means: A doctor in Louisiana can accept an appointment to the Medical Advisory Committee, do the bidding of the pharmaceutical and medical device industries, develop guidelines that absolutely do NOT adhere to the legislative mandate of SB303, leave the state work comp system in worse shape than it was already in... and all records, emails, transcripts, etc. connected to their work can be hidden from the light of day and they can never be called to testify in any forum to defend their judgment?
I spoke to both Dixon and Broadwater. Broadwater told me that the intent of HB 126 is to protect voluntary participation on the part of medical experts on such committees from inappropriate harassment. Further, his position is that the rule-making process, public comment period, and ongoing opportunity to amend the medical treatment guidelines provide sufficient transparency in the system that knowing exactly who is influencing the MAC isn't relevant.
I respectfully disagree. If these people really are the "experts," I want assurances that their judgment, their expertise, and their counsel isn't being clouded by drug and device manufacturers. Let's be realistic: the MAC may not have any rule making authority at all, but their advice (as experts) defines the default rules for public consideration. How do we know we're starting off on the right foot?
So, to sum up...
Dear Governor Jindal,
Don't sign this bill into law.
Sincerely,
All of us out here who think responsibility and accountability are fundamental tenets of government.
Michael
On Twitter @PRIUM1
Monday, June 4, 2012
Do You Know Your MEDs? A Powerful Metric for Opioid Management
MED stands for morphine equivalent dosage. And you should immediately start using it (if you're not already) to identify and mitigate the potentially harmful effects of chronic opioid use.
Different formulations of opioids can be compared to one another (and the real extent of opioid therapy can be established) by converting each drug to its morphine equivalent dosage. Each opioid has an "MED conversion factor" and there are simple calculators available online (the State of Washington's is particularly useful: http://agencymeddirectors.wa.gov/mobile.html)
The Official Disability Guidelines chapter on pain has a helpful overview for how to interpret the data and keep claimants safe:
Different formulations of opioids can be compared to one another (and the real extent of opioid therapy can be established) by converting each drug to its morphine equivalent dosage. Each opioid has an "MED conversion factor" and there are simple calculators available online (the State of Washington's is particularly useful: http://agencymeddirectors.wa.gov/mobile.html)
The Official Disability Guidelines chapter on pain has a helpful overview for how to interpret the data and keep claimants safe:
"Recommend that dosing not exceed 120 mg oral morphine equivalents per day. Opioids may be recommended as a 2nd or 3rd line treatment at doses ≤ 120 mg daily oral morphine equivalent dose (MED). Risk benefit of use should be evaluated, including that of substance abuse and death. An accurate diagnosis should be established and it is strongly recommended that a psychological evaluation occur before starting this class of drugs. Escalation of doses greater that 120 mg (MED) should be done with caution, and generally under the care of pain specialists, and in certain cases, addiction specialists, with the understanding that many patients who progress to chronic opioid therapy have underlying psychiatric disease and substance abuse issues."
Take a patient on 30 mg of oxycondone, twice a day (60 mg total) and Exalgo (hydromorphone ER) 16 mg twice a day (32 mg total). The morphine equivalent of the oxycodone is 90 mg per day (MED conversion factor of 1.5) and the morphine equivalent of the hydromorphone is 128 mg per day (MED converstion factor of 4.0). This leads to a total morphine equivalent dosage of 218 mg per day. This is a major problem.
There is significant evidence that suggests the 120 mg MED threshold should be taken very seriously. One of the clearest pieces of evidence comes from a paper published last December by Gary Franklin and colleagues from Washington State Labor and Industries. After the introduction of opioid dosing guidelines in 2007, Dr. Franklin and his team measured the impact: "Compared to before 2007, there has been a substantial decline in both the MED/day of long-acting DEA Schedule II opioids (by 27%) and the proportion of workers on doses ≥120 md/day MED (by 35%). There was a 50% decrease from 2009 to 2010 in the number of deaths."
Pay attention to MEDs and be prepared to identify and intervene on the claimant's behalf if the 120 mg threshold is breached.
Friday, June 1, 2012
The Jury is In: Suffolk County, NY Shines a Light
A grand jury in Suffolk County, NY has issued a 100 page report that represents both a thorough historical analysis of the growth in opioid utilization as well as a stunningly broad solution set for addressing the problem. You can find the full report here.
The grand jury was empaneled as a consequence of a horrific crime committed in the county in June of 2011. Four innocent people were murdered during a pharmacy robbery in which the gunman sought not cash, but Vicodin. The grand jury's task was to "complete an investigation into the diversion and dissemination of controlled substances and issues related thereto."
What resulted, however, was a report that will prove itself useful to all of us fighting the problem of prescription drug over-utilization and, I would argue, a decent blue print for attacking the problem from a legislative and regulatory perspective.
A few highlights (emphasis added):
"As previously noted, prescribers must obtain DEA authorization to issue prescriptions for controlled substances. However, there is no prerequisite of specialized training, board certification or continuing medical education required as a prerequisite at the federal or state level. Prescribers are authorized to issue prescriptions for analgesics, having the same addiction potential as heroin, without any specialized training or certification. This is unacceptable."
"Because, over time, chronic pain has become a commonly accepted diagnosis and condition, prescribers are fearful of malpractice suits and repercussions from professional organizations for under-treating pain; in turn, they have responded by overprescribing to ensure that the patient is satisfied with their treatment. As a result, prescribers are issuing more prescriptions for opioids and in higher doses."
"In essence, this highly addictive class of drugs has been readily prescribed for a condition that is poorly understood by practitioners. The explosion of opioid treatment for a poorly defined medical condition lies with pharmaceutical companies whose aggresive marketing of these drugs has persuaded practitioners of their value."
Add this report to your reading list. Great data, well researched, excellently articulated.
Michael
On Twitter @PRIUM1
The grand jury was empaneled as a consequence of a horrific crime committed in the county in June of 2011. Four innocent people were murdered during a pharmacy robbery in which the gunman sought not cash, but Vicodin. The grand jury's task was to "complete an investigation into the diversion and dissemination of controlled substances and issues related thereto."
What resulted, however, was a report that will prove itself useful to all of us fighting the problem of prescription drug over-utilization and, I would argue, a decent blue print for attacking the problem from a legislative and regulatory perspective.
A few highlights (emphasis added):
"As previously noted, prescribers must obtain DEA authorization to issue prescriptions for controlled substances. However, there is no prerequisite of specialized training, board certification or continuing medical education required as a prerequisite at the federal or state level. Prescribers are authorized to issue prescriptions for analgesics, having the same addiction potential as heroin, without any specialized training or certification. This is unacceptable."
"Because, over time, chronic pain has become a commonly accepted diagnosis and condition, prescribers are fearful of malpractice suits and repercussions from professional organizations for under-treating pain; in turn, they have responded by overprescribing to ensure that the patient is satisfied with their treatment. As a result, prescribers are issuing more prescriptions for opioids and in higher doses."
"In essence, this highly addictive class of drugs has been readily prescribed for a condition that is poorly understood by practitioners. The explosion of opioid treatment for a poorly defined medical condition lies with pharmaceutical companies whose aggresive marketing of these drugs has persuaded practitioners of their value."
Add this report to your reading list. Great data, well researched, excellently articulated.
Michael
On Twitter @PRIUM1
Friday, May 25, 2012
We Know Too Much: New Liabilities Associated with Opioid Abuse
A new ruling from Texas adds to the list of states that have found payers liable for a range of opioid-related side effects ranging from addiction to death. In this particular case, the payer was found liable for death benefits in light of the injured worker's death caused by hydrocodone overdose. This adds to recent rulings in several other jurisdictions (e.g., Pennsylvania, Texas, North Carolina - these are the ones I've seen, I believe there are others) in which payers have found themselves on the hook for death benefits due to drug overdose.
Prediction: This is just the beginning. Why? Because we know too much. And our unwillingness (or inability), as an industry, to apply what we know is going to cause a lot of financial pain over the next several years.
We really do know too much. We have sound, evidence-based clinical guidelines. We have peer reviewed studies (many of which are incorporated into the guidelines) that suggest the limited benefits (and significant harm) that results from chronic opioid therapy. We have thought leaders, in both the clinical and business realms, offering a constant drumbeat of warnings that solutions are needed. We have industry conferences devoted entirely to this issue. We have a growing body of regulatory mechanisms intended to help control opioid misuse (e.g., Texas closed formulary rules, new Tennessee UR rules, Washington's guidelines, etc.) We have public health agencies, including the CDC, calling the issue of prescription drug abuse an "epidemic" and a "public health crisis".
I hear various excuses for why payer organizations aren't attacking the problem with greater force. "Look," they say, "this is really complicated... these people are addicted". Or "we don't have sufficient clinical resources"... or "we're pretty sure plaintiff's counsel is going to come at us pretty hard"... or "we're working on it"... or "our PBM has a handle on it".
Enough. There's going to be noise. Deal with it. We're on the right side of this fight. By taking aggressive action, we have the opportunity to improve overall patient health while simultaneously saving money. This is exactly what our health care system needs.
Let's get to work.
Michael
On Twitter @PRIUM1
Prediction: This is just the beginning. Why? Because we know too much. And our unwillingness (or inability), as an industry, to apply what we know is going to cause a lot of financial pain over the next several years.
We really do know too much. We have sound, evidence-based clinical guidelines. We have peer reviewed studies (many of which are incorporated into the guidelines) that suggest the limited benefits (and significant harm) that results from chronic opioid therapy. We have thought leaders, in both the clinical and business realms, offering a constant drumbeat of warnings that solutions are needed. We have industry conferences devoted entirely to this issue. We have a growing body of regulatory mechanisms intended to help control opioid misuse (e.g., Texas closed formulary rules, new Tennessee UR rules, Washington's guidelines, etc.) We have public health agencies, including the CDC, calling the issue of prescription drug abuse an "epidemic" and a "public health crisis".
I hear various excuses for why payer organizations aren't attacking the problem with greater force. "Look," they say, "this is really complicated... these people are addicted". Or "we don't have sufficient clinical resources"... or "we're pretty sure plaintiff's counsel is going to come at us pretty hard"... or "we're working on it"... or "our PBM has a handle on it".
Enough. There's going to be noise. Deal with it. We're on the right side of this fight. By taking aggressive action, we have the opportunity to improve overall patient health while simultaneously saving money. This is exactly what our health care system needs.
Let's get to work.
Michael
On Twitter @PRIUM1
Thursday, May 24, 2012
Health Wonk Review
Health Wonk Review is up. Thanks to Jaan Sidorov at Disease Management Care Blog for hosting.
Enjoy!
http://diseasemanagementcareblog.blogspot.com/2012/05/health-wonk-review-come-back-well-leave.html
On Twitter @PRIUM1
On Twitter @PRIUM1
Wednesday, May 23, 2012
Attitude Matters: A Case Study
A couple of weeks ago, Bob Wilson at WorkersCompensation.com wrote a piece called "Breaking the Cylce of Entitlement." Apparently, Bob caught a lot of flack from injured workers. Bob claims they missed his point (and I agree). He wrote a second piece in an attempt to clarify.
Last week, I highlighted a study from German researchers suggesting that exercise could be a key to managing chronic pain without the need for prescription opioids. I got feedback on that post similar to what Bob received on his original article. Apparently, the phrase "Grab Your Running Shoes" offended people who don't feel they have the ability to do so.
Two days ago, Bob posted this video. After watching it, I realized we could have skipped all of the articles, the back and forth, the arguing, etc. and just asked people to watch this.
Attitude matters. Don't ever let anyone tell you how the rest of your life is going to play out. Even if you've been injured. Even if you're in pain. Even if your own doctors are telling you it's not going to get better.
Michael
On Twitter @PRIUM1
Last week, I highlighted a study from German researchers suggesting that exercise could be a key to managing chronic pain without the need for prescription opioids. I got feedback on that post similar to what Bob received on his original article. Apparently, the phrase "Grab Your Running Shoes" offended people who don't feel they have the ability to do so.
Two days ago, Bob posted this video. After watching it, I realized we could have skipped all of the articles, the back and forth, the arguing, etc. and just asked people to watch this.
Attitude matters. Don't ever let anyone tell you how the rest of your life is going to play out. Even if you've been injured. Even if you're in pain. Even if your own doctors are telling you it's not going to get better.
Michael
On Twitter @PRIUM1
Monday, May 21, 2012
Age and Opioid Misuse: Probably Not What You Think
Ameritox announced last week the release of a peer-reviewed poster at the annual meeting of the American Pain Society that draws some surprising conclusions about age and opioid misuse. Turns out being older doesn't necessarily make you more responsible.
The study is based on over 700,000 urine drug monitoring samples from chronic pain patients over the age of 50. Notable results:
7.6% had an illicit drug detected (e.g., marijuana, cocaine metabolite, heroin metabolite or PCP)
28.1% had a non-prescribed drug detected (e.g., opiates, benzodiazepines, barbiturates, etc.)
31.8% did not have a prescribed drug detected (e.g., a prescribed pain medication)
45.9% of samples had no abnormality found.
Wow. 54% of the samples had some inconsistency detected.
I've learned from past experience (and from conversations with Dr. Leider, Chief Medical Officer for Ameritox) that one cannot jump to conclusions based on UDM testing alone. Grandpa isn't necessarily selling his Oxycontin just because it didn't show up in his drug screen.
But this study does suggest that equal vigilance is required by the medical community (physicians, payors, caregivers, etc.) in monitoring opioid use among older patients as with younger patients. It would be entirely inappropriate for a physician to forego regular, random drug screening for a chronic pain patient on opioid therapy just because the patient appears old enough to have grandkids.
It's also important to note that even a perfectly implemented drug monitoring program can't fix these issues by itself. A strong UDM program should prompt conversations between prescribers and patients to ensure that the right therapy is being delivered safely and effectively to accomplish the established treatment goals. If nefarious behavior is uncovered, providers need to act judiciously to ensure the patient has an opportunity to get help if needed.
Michael
On Twitter @PRIUM1
The study is based on over 700,000 urine drug monitoring samples from chronic pain patients over the age of 50. Notable results:
Wow. 54% of the samples had some inconsistency detected.
I've learned from past experience (and from conversations with Dr. Leider, Chief Medical Officer for Ameritox) that one cannot jump to conclusions based on UDM testing alone. Grandpa isn't necessarily selling his Oxycontin just because it didn't show up in his drug screen.
But this study does suggest that equal vigilance is required by the medical community (physicians, payors, caregivers, etc.) in monitoring opioid use among older patients as with younger patients. It would be entirely inappropriate for a physician to forego regular, random drug screening for a chronic pain patient on opioid therapy just because the patient appears old enough to have grandkids.
It's also important to note that even a perfectly implemented drug monitoring program can't fix these issues by itself. A strong UDM program should prompt conversations between prescribers and patients to ensure that the right therapy is being delivered safely and effectively to accomplish the established treatment goals. If nefarious behavior is uncovered, providers need to act judiciously to ensure the patient has an opportunity to get help if needed.
Michael
On Twitter @PRIUM1
Friday, May 18, 2012
Pain Management Without Drugs: Grab Your Running Shoes
Interesting study in the journal Pain (here's an article that provides a brief overview).
The basic premise is that while most of us have similar pain thresholds, athletes (specifically, endurance athletes) have developed superior coping mechanisms that help them deal with chronic pain, even while they're at rest. One potential conclusion is that exercise may be a key to dealing with chronic pain, both psychologically and physically. This study caught my eye for both professional and personal reasons - I've been a long distance runner and, more recently, an amateur triathlete (heavy emphasis on "amateur") for many years and I've always felt that the psychological and physical rigor that comes with endurance athletics created benefit outside of the exercise itself.
The study is actually a meta-analysis of 15 studies and was conducted by German researchers at the University of Heidelberg. The authors note: "Athletes are frequently exposed to unpleasant sensory experiences during their daily physical efforts, and high physical and psychological resistances must be overcome during competitions or very exhausting activities. However, athletes are forced to develop efficient pain-coping skills because of their systematic exposure to brief periods of intense pain."
I'll add that there's a side benefit to introducing exercise as a key component of dealing with chronic pain - it may help stem the rise of obesity as one of the most common comorbid conditions related to industrial injury. I'd also hypothesize that it would help with depression as well.
Fewer pills... more exercise... the world would be a better place (and medical care wouldn't be nearly as expensive).
Michael
On Twitter @PRIUM1
The basic premise is that while most of us have similar pain thresholds, athletes (specifically, endurance athletes) have developed superior coping mechanisms that help them deal with chronic pain, even while they're at rest. One potential conclusion is that exercise may be a key to dealing with chronic pain, both psychologically and physically. This study caught my eye for both professional and personal reasons - I've been a long distance runner and, more recently, an amateur triathlete (heavy emphasis on "amateur") for many years and I've always felt that the psychological and physical rigor that comes with endurance athletics created benefit outside of the exercise itself.
The study is actually a meta-analysis of 15 studies and was conducted by German researchers at the University of Heidelberg. The authors note: "Athletes are frequently exposed to unpleasant sensory experiences during their daily physical efforts, and high physical and psychological resistances must be overcome during competitions or very exhausting activities. However, athletes are forced to develop efficient pain-coping skills because of their systematic exposure to brief periods of intense pain."
I'll add that there's a side benefit to introducing exercise as a key component of dealing with chronic pain - it may help stem the rise of obesity as one of the most common comorbid conditions related to industrial injury. I'd also hypothesize that it would help with depression as well.
Fewer pills... more exercise... the world would be a better place (and medical care wouldn't be nearly as expensive).
Michael
On Twitter @PRIUM1
Thursday, May 17, 2012
Connecticut Opioid Protocols: Great Step, Now Let Us Talk to the Docs
The State of Connecticut's Workers' Compensation Commission (WCC) released revised protocols for opioid prescribing. Like several other states, CT goes out of its way to emphasize that "the protocols are not meant to be absolute; there must be room for medical judgment." Granted.
I was pleased to read, though, that the WCC has placed a 90 mg morphine equivalent dosage (MED) per day as the threshold above which opioid treatment should not rise unless there is "measured improvement in function, pain, or work capacity" (which we almost never see - once you get in the 100 mg MED range, we consistently see evidence in medical records of declining function). Most of the literature suggests 120 mg MED as an appropriate threshold, so the more aggressive approach in CT is enlightened.
I also thought it was interesting that the WCC encourages treating physicians to contact the insurer if treatment beyond the protocol is needed. I'm left wondering how nice it would be if the reverse was possible - if the insurer could easily and reliably engage the treating physician to discuss the care of the patient.
In CT, communication between payor and the attending physician where such communication would involve unilateral disclosure or discussion of material information is not allowed.
Payors, however, may request the physician to complete the "Employee Medical & Work Status Form" form or provide progress notes. Copies of this communication, as well as any responses from the physician, must be provided to the injured worker or his/her representative (Payor and Medical Provider Guidelines to Improve the Coordination of Medical Services, 2010).
But there is no allowance for the insurer to launch a call to the treating physician and say, "Hey Dr. Smith... can we chat about why Joe has been on OxyContin for three years? The evidence suggests that might not be good for him. Are there mitigating circumstances? Do you need help with weaning? How can we be of assistance?" In CT, that call can't happen. And that's a shame.
Workers compensation attorneys in Connecticut agree that these guidelines are strictly followed and that there is no ex parte communication with treating physicians. The only time that ex parte communication is permitted is when the claimant has approved a Nurse Case Manager. In that case the NCM may discuss treatment and medical data with the treating physician. But how many plaintiff's attorneys are going to say to their clients, "Yeah, sure, let's get an NCM involved"? Not many.
These WCC rules make it nearly impossible for insurers to collegially engage treating physicians in CT to discuss how best to rationalize pharmacological treatment. CT is one of the few states where this is the case.
Michael
On Twitter @PRIUM1
I was pleased to read, though, that the WCC has placed a 90 mg morphine equivalent dosage (MED) per day as the threshold above which opioid treatment should not rise unless there is "measured improvement in function, pain, or work capacity" (which we almost never see - once you get in the 100 mg MED range, we consistently see evidence in medical records of declining function). Most of the literature suggests 120 mg MED as an appropriate threshold, so the more aggressive approach in CT is enlightened.
I also thought it was interesting that the WCC encourages treating physicians to contact the insurer if treatment beyond the protocol is needed. I'm left wondering how nice it would be if the reverse was possible - if the insurer could easily and reliably engage the treating physician to discuss the care of the patient.
In CT, communication between payor and the attending physician where such communication would involve unilateral disclosure or discussion of material information is not allowed.
Payors, however, may request the physician to complete the "Employee Medical & Work Status Form" form or provide progress notes. Copies of this communication, as well as any responses from the physician, must be provided to the injured worker or his/her representative (Payor and Medical Provider Guidelines to Improve the Coordination of Medical Services, 2010).
But there is no allowance for the insurer to launch a call to the treating physician and say, "Hey Dr. Smith... can we chat about why Joe has been on OxyContin for three years? The evidence suggests that might not be good for him. Are there mitigating circumstances? Do you need help with weaning? How can we be of assistance?" In CT, that call can't happen. And that's a shame.
Workers compensation attorneys in Connecticut agree that these guidelines are strictly followed and that there is no ex parte communication with treating physicians. The only time that ex parte communication is permitted is when the claimant has approved a Nurse Case Manager. In that case the NCM may discuss treatment and medical data with the treating physician. But how many plaintiff's attorneys are going to say to their clients, "Yeah, sure, let's get an NCM involved"? Not many.
These WCC rules make it nearly impossible for insurers to collegially engage treating physicians in CT to discuss how best to rationalize pharmacological treatment. CT is one of the few states where this is the case.
Michael
On Twitter @PRIUM1
Wednesday, May 16, 2012
A Tale of Two Claim Types: Healthcare Solutions Drug Trends Report
The first thing you notice about the 2012 Workers' Compensation Drug Trends Report from Healthcare Solutions is that the authors have decided to tell two different stories with the data - one focused on "developing claims" (0-3 years from date of injury) and another focused on "mature claims" (3+ years from the date of injury).
Kudos to Jim Andrews and his team for giving us some insight into what all of us intuitively suspected as we examined other drug trend reports: that the behavior of claims changes markedly over time... and that looking at all claims together in one big lump wasn't allowing us to glean intelligent conclusions.
If I had one request, though, it would be to create an even more granular look at the data. The report notes that "significant increases in both the number of prescriptions and the prices of prescriptions occur in the first three years of a claim. The most significant increase occurs between the first and second service year when a 65% increase in the number of prescriptions and a 76% increase in the average price per prescriptions is observed." Instead of grouping these claims into the "developing" category, I think it would be fascinating to pull the data set into a sub-set of first year, second year, and third year claims to see how drug mix, drug class, and spend change even within that time period. But then the report would run 100 pages instead of 25...
The most interesting story that I see in the data is around the long term impact of opioid use. Among developing claims, opioids are used by 65.7% of injured workers while other drug classes are relatively uncommon in this stage of the claim life cycle (anticonvulsants are used by 9.9% of injured workers, antidepressants by 4.8%, and ulcer drugs by 2.4%).
And what happens as claims age into the "mature" category? Opioids are used by 71.2% of these injured workers. But more importantly, we begin to see the complexities of long term use of analgesics. The side effects are clear: depression (antidepressant use goes up almost 5X to 23.5% of injured workers), neuropathic - or idiopathic - pain (anticonvulsant usages goes up almost 3X to 28.2%), and GI issues (usage of ulcer drugs goes up more than 5X to 12.4% of injured workers).
Coincidence? No.
A direct consequence of the original work injury? Probably not.
Additional costs being driven by underlying overutilization of narcotics? Most likely.
Michael
On Twitter @PRIUM1
Kudos to Jim Andrews and his team for giving us some insight into what all of us intuitively suspected as we examined other drug trend reports: that the behavior of claims changes markedly over time... and that looking at all claims together in one big lump wasn't allowing us to glean intelligent conclusions.
If I had one request, though, it would be to create an even more granular look at the data. The report notes that "significant increases in both the number of prescriptions and the prices of prescriptions occur in the first three years of a claim. The most significant increase occurs between the first and second service year when a 65% increase in the number of prescriptions and a 76% increase in the average price per prescriptions is observed." Instead of grouping these claims into the "developing" category, I think it would be fascinating to pull the data set into a sub-set of first year, second year, and third year claims to see how drug mix, drug class, and spend change even within that time period. But then the report would run 100 pages instead of 25...
The most interesting story that I see in the data is around the long term impact of opioid use. Among developing claims, opioids are used by 65.7% of injured workers while other drug classes are relatively uncommon in this stage of the claim life cycle (anticonvulsants are used by 9.9% of injured workers, antidepressants by 4.8%, and ulcer drugs by 2.4%).
And what happens as claims age into the "mature" category? Opioids are used by 71.2% of these injured workers. But more importantly, we begin to see the complexities of long term use of analgesics. The side effects are clear: depression (antidepressant use goes up almost 5X to 23.5% of injured workers), neuropathic - or idiopathic - pain (anticonvulsant usages goes up almost 3X to 28.2%), and GI issues (usage of ulcer drugs goes up more than 5X to 12.4% of injured workers).
Coincidence? No.
A direct consequence of the original work injury? Probably not.
Additional costs being driven by underlying overutilization of narcotics? Most likely.
Michael
On Twitter @PRIUM1
Tuesday, May 15, 2012
Pop Quiz in the WSJ: Get Rid of Painkillers
This morning's Wall Street Journal had an interesting article in the Personal Journal section called "The Medicine Cabinet Quiz." (Yes... I am one of the last few that actually gets a paper delivered in my driveway each morning). One of the questions, in particular, caught my attention:
Q: For a sore back or sprained ankle, which options make sense?
A) Heat
B) Ice
C) Heat rub
D) Prescription painkiller
The answer was obvious to most of us: A, B, and C (conspicuous in its absence was choice D). The article explains: "While many people don't finish prescriptions for Percocet, Vicodin, or generic equivalents prescribed after surgery or dental work, it is a bad idea to take them for something else. Leftover painkillers are an invitation for abuse - by yourself, by your children, or by nosy visitors. Studies show that 68% of prescription drug abusers obtain them from home or from friends."
If you've got leftover pills sitting around, get rid of them. Today.
Michael
On Twitter @PRIUM1
Q: For a sore back or sprained ankle, which options make sense?
A) Heat
B) Ice
C) Heat rub
D) Prescription painkiller
The answer was obvious to most of us: A, B, and C (conspicuous in its absence was choice D). The article explains: "While many people don't finish prescriptions for Percocet, Vicodin, or generic equivalents prescribed after surgery or dental work, it is a bad idea to take them for something else. Leftover painkillers are an invitation for abuse - by yourself, by your children, or by nosy visitors. Studies show that 68% of prescription drug abusers obtain them from home or from friends."
If you've got leftover pills sitting around, get rid of them. Today.
Michael
On Twitter @PRIUM1
Monday, May 14, 2012
American Pain Foundation Shuts Down
The American Pain Foundation announced last Tuesday evening that it would "cease to exist, effective immediately." That should make all of us fighting prescription drug abuse "very happy, effective immediately."
The organization had received a letter from the Senate Finance Committee notifying it of an investigation launched by the committee to uncover the details of relationships amongst pharmaceutical manufacturers, physicians, and "patient advocacy" organizations like the American Pain Foundation. This comes on the heels of a great piece by ProPublica in December that found the group had received 90% of its funding in 2010 from the pharma and medical device indisturies.
Turns out, this made it hard for APF to find anyone to give them money.
On its web site, the group states the following: "As you unfortunately know, the need for public outcry around the needs of Americans struggling with pain conditions is greater today than ever before in light of the multi-front assault occurring daily on our right to dignified care. Misguided state and federal policies are impeding access to appropriate and reasonable medical care for people struggling with pain, and deterring even the most compassionate medical providers from treating anyone with pain conditions."
You see? This is why the dissolution of the organization is a good thing. While the rest of us are fighting to ensure the appropriate use of prescription medications, this group was complaining about "misguided state and federal policies." While we acknowledged that new statutes and rules should (and many do) create carve-outs for those with cancer diagnoses and instead focused our efforts on limiting the use of powerful narcotics for non-malignant musculoskeletal pain, the APF told anecdotal stories about patients not able to access needed drugs.
An early victory for Senators Grassley and Baucus. Unintended, perhaps... but a victory nonetheless.
Michael
On Twitter @PRIUM1
The organization had received a letter from the Senate Finance Committee notifying it of an investigation launched by the committee to uncover the details of relationships amongst pharmaceutical manufacturers, physicians, and "patient advocacy" organizations like the American Pain Foundation. This comes on the heels of a great piece by ProPublica in December that found the group had received 90% of its funding in 2010 from the pharma and medical device indisturies.
Turns out, this made it hard for APF to find anyone to give them money.
On its web site, the group states the following: "As you unfortunately know, the need for public outcry around the needs of Americans struggling with pain conditions is greater today than ever before in light of the multi-front assault occurring daily on our right to dignified care. Misguided state and federal policies are impeding access to appropriate and reasonable medical care for people struggling with pain, and deterring even the most compassionate medical providers from treating anyone with pain conditions."
You see? This is why the dissolution of the organization is a good thing. While the rest of us are fighting to ensure the appropriate use of prescription medications, this group was complaining about "misguided state and federal policies." While we acknowledged that new statutes and rules should (and many do) create carve-outs for those with cancer diagnoses and instead focused our efforts on limiting the use of powerful narcotics for non-malignant musculoskeletal pain, the APF told anecdotal stories about patients not able to access needed drugs.
An early victory for Senators Grassley and Baucus. Unintended, perhaps... but a victory nonetheless.
Michael
On Twitter @PRIUM1
Quick Hits from Evidence Based: NCCI, CA, and IL
NCCI released research data on comorbidities in work comp:
- Claims that involve comorbid conditions are TWICE as expensive as claims that do not.
- 81% of claims that involved treatment for obesity involved lost time, 19% were medical only.
- For all claims, it's the exact OPPOSITE: 81% are medical only, 19% involve lost time.
Wow.
A California bill passed out of committee last week that will award attorney's fees in successful challenges to utilization review decisions. A consultant to the Appropriations Committee said the bill would have minimal impact because "somewhere between 6% and 20% of all utilization review requests result in denial and of those, only a portion will be challenged."
Yeah... until attorney's fees are awarded for successful challenges. In light of systemic change, historical data has little bearing on future system behavior.
Illinois state lawmakers will vote soon on privatizing management of state workers' comp claims. Organized labor is pushing back, but this is a logical step given the absolute and unmitigated disaster the state auditor found. I wonder if there are other state funds as screwed up as Illinois?
On Twitter @PRIUM1
- Claims that involve comorbid conditions are TWICE as expensive as claims that do not.
- 81% of claims that involved treatment for obesity involved lost time, 19% were medical only.
- For all claims, it's the exact OPPOSITE: 81% are medical only, 19% involve lost time.
Wow.
A California bill passed out of committee last week that will award attorney's fees in successful challenges to utilization review decisions. A consultant to the Appropriations Committee said the bill would have minimal impact because "somewhere between 6% and 20% of all utilization review requests result in denial and of those, only a portion will be challenged."
Yeah... until attorney's fees are awarded for successful challenges. In light of systemic change, historical data has little bearing on future system behavior.
Illinois state lawmakers will vote soon on privatizing management of state workers' comp claims. Organized labor is pushing back, but this is a logical step given the absolute and unmitigated disaster the state auditor found. I wonder if there are other state funds as screwed up as Illinois?
On Twitter @PRIUM1
Thursday, May 10, 2012
New Health Wonk Review
New Health Wonk Review is up... with Evidence Based making another appearance!
http://insureblog.blogspot.com/2012/05/health-wonk-review-spring-hath-sprung.html
Michael
On Twitter @PRIUM1
http://insureblog.blogspot.com/2012/05/health-wonk-review-spring-hath-sprung.html
Michael
On Twitter @PRIUM1
Something Rotten in the State of Opioid Prescribing
There's something rotten in the state of opioid prescribing...
The New York Times reported yesterday that the Senate Finance Committee has launched an investigation into the financial ties amongst pharmaceutical manufacturers of analgesics, pain "experts," advocacy groups, and organizations that set guidelines for the use of these drugs.
Tired of partisan politics in Washington? The letter that went out announcing the investigation was signed by Max Baucus (D-Montana) and Charles Grassley (R-Iowa). This is a bi-partisan slam dunk. While I don't have any direct evidence of malfeasance, I'm not the least bit surprised that the committee has chosen this as an area of focus.
As a quick aside, the Times article quotes Dr. Andrew Kolodny, a psychiatrist in New York. I mention this for two reasons: 1) I've met Dr. Kolodny and think highly not only of his stance on these issues, but also of the way he communicates his perspective; 2) He leads the Physicians for Responsible Opioid Prescribing, the web site of which is an outstanding resource to get educated on the topic of opioid over-utilization. We use the videos here at PRIUM for training and we recommend the site as a resource to our insurance and employer clients looking for free, web-based education tools. Excellent stuff.
Back to the investigation...
I recently had occasion to discuss the issue of opioid over-utilization with leaders from a couple of these companies. I brought up the topic of evidence-based medicine and clinical guidelines. I further explained the growing role of these tools in work comp. I was surprised by two things:
1) The concept seemed completely new to them; 2) the looks on their faces were priceless: it was as if I had committed some unforgivable offense. Monitor, influence, or perhaps even CHANGE a physician's prescribing habits based on peer-reviewed medical evidence? Who would do such a thing?
This is an industry that needs to be investigated. I'm encouraged the Senate is taking action. This is a public health crisis and it demands this level of scrutiny.
If nothing else, we're all going to get a really good peek at how this industry really operates.
Michael
On Twitter @PRIUM1
The New York Times reported yesterday that the Senate Finance Committee has launched an investigation into the financial ties amongst pharmaceutical manufacturers of analgesics, pain "experts," advocacy groups, and organizations that set guidelines for the use of these drugs.
Tired of partisan politics in Washington? The letter that went out announcing the investigation was signed by Max Baucus (D-Montana) and Charles Grassley (R-Iowa). This is a bi-partisan slam dunk. While I don't have any direct evidence of malfeasance, I'm not the least bit surprised that the committee has chosen this as an area of focus.
As a quick aside, the Times article quotes Dr. Andrew Kolodny, a psychiatrist in New York. I mention this for two reasons: 1) I've met Dr. Kolodny and think highly not only of his stance on these issues, but also of the way he communicates his perspective; 2) He leads the Physicians for Responsible Opioid Prescribing, the web site of which is an outstanding resource to get educated on the topic of opioid over-utilization. We use the videos here at PRIUM for training and we recommend the site as a resource to our insurance and employer clients looking for free, web-based education tools. Excellent stuff.
Back to the investigation...
I recently had occasion to discuss the issue of opioid over-utilization with leaders from a couple of these companies. I brought up the topic of evidence-based medicine and clinical guidelines. I further explained the growing role of these tools in work comp. I was surprised by two things:
1) The concept seemed completely new to them; 2) the looks on their faces were priceless: it was as if I had committed some unforgivable offense. Monitor, influence, or perhaps even CHANGE a physician's prescribing habits based on peer-reviewed medical evidence? Who would do such a thing?
This is an industry that needs to be investigated. I'm encouraged the Senate is taking action. This is a public health crisis and it demands this level of scrutiny.
If nothing else, we're all going to get a really good peek at how this industry really operates.
Michael
On Twitter @PRIUM1
Wednesday, May 9, 2012
Obesity Outlook for 2030: Not Good News
The American Journal of Preventive Medicine published a study this week that appears to offer a glimmer of hope for the health care industry: the data (collected from 1990 through 2008) suggests that the prevalence of obesity might be leveling off. In other words, the linear regression models typically used to forecast obesity rates (and the related costs), may not be accurate. Rather, non-linear forecasting techniques now suggest the obesity rate in 2030 may be around 42% (vs. the 51% that the linear model indicates).
Good news, right?
Not really. While the growth of obesity may be moderating, the rise in prevalence is still incredible. The study shows a 33% increase in obesity between now and 2030 and a 130% increase in severe obesity over the same time frame.
The headline grabbing number many of us have seen from this study is the $549.5 billion in potential cost savings. This number assumes that the 2010 obesity rate remains constant through 2030. Nice mathematical exercise... but completely useless in reality.
Digging more deeply into the statistics (and looking for a silver lining), there is some more practical and encouraging data... A 1 percentage point decrease from the prevalence rate suggested by the model would yield 2.6 million fewer obese adults in 2020 and 2.9 million fewer in 2030. This would lead to a reduction in obesity-related medical costs of $4 billion in 2020, $4.7 billion in 2030, and a cumulative total of $84.9 billion over the next 20 years. That strikes me as achievable.
What does all of this mean?
The obesity issue in work comp is only going to get worse - it's simply a matter of how bad it gets and how quickly it gets there. Bold prediction: we're going to see some new and aggressive case law over the next decade that is going to give employers more latitude to protect themselves against obesity-related medical costs, even in the face of a legitimate industrial injury. Don't hold your breath, but I can't see the medical benefit component of work comp being sustainable without such systemic protection.
Michael
On Twitter @PRIUM1
Good news, right?
Not really. While the growth of obesity may be moderating, the rise in prevalence is still incredible. The study shows a 33% increase in obesity between now and 2030 and a 130% increase in severe obesity over the same time frame.
The headline grabbing number many of us have seen from this study is the $549.5 billion in potential cost savings. This number assumes that the 2010 obesity rate remains constant through 2030. Nice mathematical exercise... but completely useless in reality.
Digging more deeply into the statistics (and looking for a silver lining), there is some more practical and encouraging data... A 1 percentage point decrease from the prevalence rate suggested by the model would yield 2.6 million fewer obese adults in 2020 and 2.9 million fewer in 2030. This would lead to a reduction in obesity-related medical costs of $4 billion in 2020, $4.7 billion in 2030, and a cumulative total of $84.9 billion over the next 20 years. That strikes me as achievable.
What does all of this mean?
The obesity issue in work comp is only going to get worse - it's simply a matter of how bad it gets and how quickly it gets there. Bold prediction: we're going to see some new and aggressive case law over the next decade that is going to give employers more latitude to protect themselves against obesity-related medical costs, even in the face of a legitimate industrial injury. Don't hold your breath, but I can't see the medical benefit component of work comp being sustainable without such systemic protection.
Michael
On Twitter @PRIUM1
Tuesday, May 8, 2012
Texas: The Clock is Ticking on Legacy Claims
Back in January, my colleague Mark Pew penned a white paper entitled "Legacy Clean Up, Texas Style." The paper encouraged stake holders in the Texas work comp system to get started on the process of addressing legacy claims in relation to the new closed formulary rules, despite a timeline in the new rules that doesn't require action until early 2013: "Given the potentially extreme physical and psychological addiction associated with these drugs, it is time to get started towards those deadlines. This should make 2012 the 'Year of Legacy Claim Cleanup' in Texas."
Yesterday, the Insurance Council of Texas (ICT) published a bulletin emphasizing the need for the work comp insurance community to get moving on this issue. The bulletin reminded stakeholders that "the DWC has urged all involved parties to begin the legacy claims transition process 'much sooner' than the rule's mandated timelines to avoid last minute complications, and to foster timely, manageable prescribing of drugs suitable to each injured employee." Further, the ICT states that "the DWC is concerned that there are insurance carriers and physicians who may wait until the 'eleventh hour' to begin the transition of legacy claims to the Closed Formulary. The DWC believes that the delay in transitioning the legacy claims could result in interruption of the delivery of medically appropriate and necessary pharmaceutical benefits."
This is a diplomatic way of saying, "September 2, 2013 [the day after the closed formulary rules go into effect for all legacy claims] is going to a very complicated day for all of us if we don't get our act together NOW!"
This is serious, folks. Texas isn't messing around here. Come September of 2013, if a drug isn't documented as medically necessary, it isn't going to be dispensed (at least, not without a medical interlocutory order).
If only there were a clear way to deal with these claims...
Good news: DWC actually thought of that! The rules provide for a mechanism for insurance carriers to engage directly with treating physicians to determine (and clearly document prior to September 1, 2013) the applicability of the closed formulary to each individual legacy claim. This is a big task and for some carriers/employers, this is going to be a huge project. So get to work!
And if you're struggling with the issue, let us know. PRIUM has developed a continuing education module on the topic and we'd be happy to share with anyone that needs help.
Michael
On Twitter @PRIUM1
Yesterday, the Insurance Council of Texas (ICT) published a bulletin emphasizing the need for the work comp insurance community to get moving on this issue. The bulletin reminded stakeholders that "the DWC has urged all involved parties to begin the legacy claims transition process 'much sooner' than the rule's mandated timelines to avoid last minute complications, and to foster timely, manageable prescribing of drugs suitable to each injured employee." Further, the ICT states that "the DWC is concerned that there are insurance carriers and physicians who may wait until the 'eleventh hour' to begin the transition of legacy claims to the Closed Formulary. The DWC believes that the delay in transitioning the legacy claims could result in interruption of the delivery of medically appropriate and necessary pharmaceutical benefits."
This is a diplomatic way of saying, "September 2, 2013 [the day after the closed formulary rules go into effect for all legacy claims] is going to a very complicated day for all of us if we don't get our act together NOW!"
This is serious, folks. Texas isn't messing around here. Come September of 2013, if a drug isn't documented as medically necessary, it isn't going to be dispensed (at least, not without a medical interlocutory order).
If only there were a clear way to deal with these claims...
Good news: DWC actually thought of that! The rules provide for a mechanism for insurance carriers to engage directly with treating physicians to determine (and clearly document prior to September 1, 2013) the applicability of the closed formulary to each individual legacy claim. This is a big task and for some carriers/employers, this is going to be a huge project. So get to work!
And if you're struggling with the issue, let us know. PRIUM has developed a continuing education module on the topic and we'd be happy to share with anyone that needs help.
Michael
On Twitter @PRIUM1
Friday, May 4, 2012
Tennessee Steps Up: UR and Narcotics Contracts
The Tennessee General Assembly passed a bill late Tuesday that will apply the utilization review process to any schedule II, III, or IV drug prescribed for more than 90 days. Further, the bill creates stiff penalties for patients that violate narcotics contracts with treating providers.
Let's look at some of the specifics. I find the following to be particularly encouraging:
1) Employers can leverage UR for drugs - excellent step. Here at PRIUM, we still believe the best path to fixing a lot of these claims is through collegial, voluntary peer-to-peer engagement... but if that doesn't work, having UR as a statutorily recognized option is very beneficial.
2) Interestingly, if a doctor refuses to prescribe a certain drug, the claimant can (on no more than one occasion) trigger the UR process on his own behalf to essentially secure a third party's view of the appropriateness of the medication therapy. I wonder how often this will be used...
3) If an injured employee violates the narcotics contract more than once (I guess everyone deserves a mulligan), the patient's "right to pain management through prescription [drugs]... shall be terminated." Tough, but appropriate.
A few concerns:
1) The UR option appears to be off the table if there is "an initial evaluation of an injured or disabled employee by a physician specializing in pain management." I see the fingerprints of the Tennessee Medical Association here. In our experience, exempting pain management specialists from oversight rests on a set of flawed and dangerous assumptions.
2) The bill doesn't require a narcotics contract. The employee "may" sign a formal written agreement. If the employee does sign such an agreement and then violates it (more than once), the penalties are clear. But the employee doesn't have to sign one... I would have liked to have seen the word "shall" here instead of "may," but these things are a negotiation and you get what you can get.
I saw an earlier draft of the bill that did say "shall" and applied the same penalties described earlier for violators to those that refused to sign a contract. That would have been interesting. That earlier version also included mandated urinary drug monitoring... that also disappeared from the final version.
Those minor concerns notwithstanding, this is an example of appropriate legislative response to a major public health issue. One particularly good sign - Rocky McElhaney from the TN Association for Justice (representing trial lawyers) said that his organization had little choice but to accept the bill. "With the governor being a Republican and Republican majorities in the House and Senate, we don't have a lot of say in legislation these days," he said.
Sad, but true, fact: When the trial lawyers don't like it, it's usually a good sign that the legislation has a chance of making a difference.
Michael
On Twitter @PRIUM1
Let's look at some of the specifics. I find the following to be particularly encouraging:
1) Employers can leverage UR for drugs - excellent step. Here at PRIUM, we still believe the best path to fixing a lot of these claims is through collegial, voluntary peer-to-peer engagement... but if that doesn't work, having UR as a statutorily recognized option is very beneficial.
2) Interestingly, if a doctor refuses to prescribe a certain drug, the claimant can (on no more than one occasion) trigger the UR process on his own behalf to essentially secure a third party's view of the appropriateness of the medication therapy. I wonder how often this will be used...
3) If an injured employee violates the narcotics contract more than once (I guess everyone deserves a mulligan), the patient's "right to pain management through prescription [drugs]... shall be terminated." Tough, but appropriate.
A few concerns:
1) The UR option appears to be off the table if there is "an initial evaluation of an injured or disabled employee by a physician specializing in pain management." I see the fingerprints of the Tennessee Medical Association here. In our experience, exempting pain management specialists from oversight rests on a set of flawed and dangerous assumptions.
2) The bill doesn't require a narcotics contract. The employee "may" sign a formal written agreement. If the employee does sign such an agreement and then violates it (more than once), the penalties are clear. But the employee doesn't have to sign one... I would have liked to have seen the word "shall" here instead of "may," but these things are a negotiation and you get what you can get.
I saw an earlier draft of the bill that did say "shall" and applied the same penalties described earlier for violators to those that refused to sign a contract. That would have been interesting. That earlier version also included mandated urinary drug monitoring... that also disappeared from the final version.
Those minor concerns notwithstanding, this is an example of appropriate legislative response to a major public health issue. One particularly good sign - Rocky McElhaney from the TN Association for Justice (representing trial lawyers) said that his organization had little choice but to accept the bill. "With the governor being a Republican and Republican majorities in the House and Senate, we don't have a lot of say in legislation these days," he said.
Sad, but true, fact: When the trial lawyers don't like it, it's usually a good sign that the legislation has a chance of making a difference.
Michael
On Twitter @PRIUM1
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