Monday, July 30, 2012

Ohio Drug Formulary: Encouraging Results

A new prescription drug formulary in Ohio, along with several other measures, appears to have reduced the dosage of narotics for work comp injuries by 12% in a year-over-year comparison conducted by Ohio Bureau of Workers' Compensation.  Costs were reduced by 15%, or $2.1 million.

Compare this to the early results from the Texas Closed Formulary - depending on the study you reference, the new rules have reduced initial opioid prescriptions for new injuries by anywhere from 50% to 67%.  And the rules don't apply to legacy claims until September of 2013. 

So, for those of you counting at home... that's two state-level formulary adoptions and two clearly favorable sets of early results. 

On Twitter @PRIUM1

Thursday, July 26, 2012

Physicians for Responsible Opioid Prescribing: Get to Know This Organization

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.   

On Twitter @PRIUM1

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. 

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.

On Twitter @PRIUM1

Thursday, July 19, 2012

Suboxone: Our View

I'm seeing and hearing a lot of advertising for 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: 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...

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?

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.

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. 

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.

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.

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. 

On Twitter @PRIUM1