Michigan Moves on Repackaged Drugs

State regulators in Michigan are working on draft rules to address drug repackaging in work comp.  Several weeks ago, I wrote a post on the 6 core tenets of any strong statutory/regulatory action in this area.  Let's see how Michigan's newly proposed rules stack up.

1) The rule doesn't ban physician dispensing. There are legitimate reasons a doctor may need to dispense medications to a patient and the rule allows for those limited circumstances.

Michigan = check. 

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.

Michigan = check. (AWP - 10% + $3.50 for brands and AWP - 10% + $5.50 for generics)

3) The rule clearly specifies the source for the AWP (Medi-Span, Redbook, etc.). Many states are silent to the AWP source and this creates a lot of noise in the system.

Michigan = check.  (Redbook)

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.

Michigan = check. 

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.

Michigan = unclear.  The Michigan rules stipulate that if a pharmaceutical bill is submitted for more than $35 using an unlisted or "not otherwise specified" code, then the bill must be accompanied by an invoice.  Not sure I follow, but at least they're thinking about it. 

6) Perhaps most importantly, this is a regulatory change, not a statutory change.  This won't be possible in all states, but where it is, it's the way to go. 

Michigan = check.

A great start for Michigan.  Well done.

Michael
On Twitter @PRIUM1

Massachusetts Prescription Drug Monitoring Program: A Critique

Massachusetts has a problem with prescription drugs in work comp.  Despite its relatively small geographic footprint, the state's doctors prescribe a lot of narcotics.  According to WCRI's report from last summer, Interstate Variations In Use of Narcotics, which studied narcotics use in 17 states, MA had the highest rate of schedule II narcotic usage among cases for which narcotics had been prescribed (for non-surgical cases experiencing >7 days of lost time). 

So I was pleased to read that Governor Patrick signed legislation recently that will strengthen the state's prescription drug monitoring program (PDMP).  A strong PDMP program is a necessary tool(albeit insufficient by itself) to help stem the over-utilization of prescription narcotics.

The law (SB 01125) requires doctors to register and pharmacists to report prescriptions to the PDMP.  And at first glace, the law requires doctors to consult the PDMP database before the issuance of a prescription for a Schedule II or III narcotic.  This would make Massachusetts only the second state to require such a step (Kentucky being the other).  A closer reading, however, shows there are nuances to the bill...

The bill reads: "The department shall promulgate rules and regulations relative to the use of the prescription monitoring program by registered participants that shall include requiring participants to utilize the prescription monitoring program prior to the issuance of a prescription for a narcotic drug contained in Schedule II or III to a patient for the first time."

So close. 

I understand the theory here.  If each prescriber must check the database at the outset of narcotic therapy, any previous prescriptions should show up.  But I fear that requiring a single consultation with the database that occurs only at the beginning of narcotic therapy will allow some patients to slip through the cracks.  The law also doesn't indicate what enforcement mechanisms will be available to the department of workers compensation to ensure compliance with the new rules (once those rules are developed). 

One additional note on the bright side: the statute does stipulate that the regulatory approach needs to allow for "licensed support staff" to conduct the database checks.  While I acknowledge that requiring PDMP checks for all narcotics scripts creates costs for the physician practice, I also believe it's in the best interest of patient safety to do so.  Allowing support staff to do that work will at least create some cost savings and efficiencies in doctors' offices throughout the state. 

Michael
On Twitter @PRIUM1

California UR: Constitutionality Aside, On the Right Track

Catching my breath after WCI last week.  Excellent conference.  Thanks to all those that took time to meet with our team or just swing by the booth. 

While digging through all of the news I missed from last week, I wasn't at all surprised to find a lot of back and forth on California work comp reform.  Of specific interest, however, was the proposal that would allow injured workers to appeal utilization review decisions only through an independent medical review process (and limiting the judiciary's ability to overturn such decisions of the independent review only to cases of fraud or conflict of interest). 

Much of the coverage on this topic has been dominated by questions of constitutionality, legal analysis, memos of such analysis that may or may not have been sent to certain people, etc. All good questions that need to be answered.

But let's look at the practical implications.  The CA UR system is fraught with gamesmanship.  If a UR request results in a non-certification, delivered in an accurate and timely fashion, the response on the part of the injured worker (and his attorney) is often predictable: Request it again... and again... and again... hoping each time that the carrier/employer screws up on a technicality (the decision is a day late or the correspondence isn't sent to all appropriate parties), thus creating an allowance for the care in question.  Obviously, we see this with medication therapy on a daily basis.

While the proposal to subject such cases to an independent medical review that has real teeth (i.e., the ability to truly shut down payment for clearly inappropriate care) is a breath of fresh air, even PRIUM's own internal counsel tells me this doesn't pass constitutional muster. 

Lawyers.

So let's amend the proposal to allow for slightly more expansive judicial review.  I'm not smart enough to figure out exactly what that means, but I do know that the guiding principle here is a good one: don't overburden the system and the WCAB with frequent and unnecessary review of obviously inappropriate care.

Michael
On Twitter @PRIUM1

Responsible Opioid Prescribing: Worth 5 Minutes of Your Time

As promised in a post several weeks ago, I'm providing additional information on how each of you will be able to support Physicians for Responsible Opioid Prescribing (PROP).  PROP has taken the lead on a petition to the FDA which seeks 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.

It's time for you to take action.  Set aside 5 minutes of your day, click here, and make your voice heard at the FDA. 

Michael
On Twitter @PRIUM1

Pill Mill in Florida: Getting Off Easy

Given the nature of our work here at PRIUM, I'm often asked about "pill mills" and the impact they have on the epidemic of prescription drug addiction in this country.  My response is always the same: Yes, we occassionally see what looks like "pill mill" activity.  But those cases are few and far between and pale in comparison (with respect to volume, complexity, and duration) to the cases that follow the more typical, albeit ineffective, medical treatment pathway under the care of a licensed physician running a perfectly legal practice. 

That said, the pill mill phenomenon represents all that is wrong with prescription drug therapy and brings into specific relief the challenges associated with stemming the tide of addiction, dependence, diversion, and every other unethical and/or illegal practice associated with prescription drugs.  As far as I'm concerned, if local or federal authorities identify a pill mill, they should shut it down and prosecute the offenders to the greatest possible extent of the law.

A recent case in Florida is cause for both confusion and concern.  Dr. Riyaz Jummani allegedly wrote scripts for approximately 500,000 oxycodone pills... in three months.  Authorities called his operation one of the busiest pill mills in the state of Florida.  This is the sort of case where an example should be made, right?  Hit him hard and send a message - run a pill mill, and you're going to jail for a very long time. 

Jummani's probable sentence (based on a "deal" with the Attorney General)?  Six months.  And in a work-release program, too. 

How is this possible?  What, exactly, is Jummani giving authorities in return for this light weight sentence?  By all accounts, Jummani was the head of the operation - it's not as if he's the #2 guy offering to testify against #1. 

If we're going to make any progress, as a society, in reigning in the inappropriate use of prescription drugs, there is a lot we're going to have to do differently.  This is an easy one.  This guy should go away for a long, long time. 

Michael
On Twitter @PRIUM1

Kentucky's HB 1: Immediate Impact

Four "pain management clinics" in Kentucky have already folded up shop.  More than 9,000 providers have registered for PDMP access since April (115% increase since HB 1 passed).   And the law went into effect just a few days ago. 

That didn't take long...

Congratulations to Kentucky, which has clearly grown tired of serving as one of our nation's best examples of how NOT to stem the tide of prescription drug abuse.  HB 1 is working and that's not just great news for Kentucky - that's great news for all states looking for legislative and regulatory templates for how to deal with this crisis. 

Last week, I posted about the new Texas PDMP.  I was disappointed to learn that physicians in Texas object to any requirement that the database be consulted prior to writing a script for a controlled substance.  Such a requirement was referred to as an "unfunded mandate." 

In Kentucky, 90% of all KASPER (Kentucky's PDMP) reports are completed within 15 to 30 seconds.  That's 15 to 30 seconds to understand the types and amounts of controlled substances a patient might already be receiving prior to a new doctor writing additional prescriptions.  This is easy, fast, and clearly in the best interests of patient safety. 

HB 1 requires providers in Kentucky to run a KASPER report before prescribing a controlled substance.  Other states should do the same. 

Michael
On Twitter @PRIUM1

New PDMP in Texas: Right Direction, Still Work To Do

Texas has moved to the next phase of its implementatin of new PDMP technology and there is a lot to like about the new iteration. 

Up until now, prescribers in Texas had to manually request data from the PDMP that would arrive via mail days after the request.  The new system, now being rolled out to almost 90,000 practitioners in the state, is an online tool from which data can be accessed in minutes. 

Combine this with the reporting requirement that went into effect last September (pharmacies must report scripts to the database within 7 days), and this starts to look like a model PDMP program.  The full release is expected by month's end and will include pharmacists and other prescribers not included in this current phase of implementation. 

One weak point, however.  While reporting is mandatory, there is no requirement that physicians prescribing drugs must check the database at all.  This part of the program is voluntary.  Dr. Chris Schade, past President of the Texas Pain Society and a beta tester of the new PDMP, summed up the physicians' view: "What doctors don't want is an unfunded mandate requiring them to use the monitoring program." 

This is fundamentally about patient safety.  Are the pre-surgical verification steps outlined by JCAHO an "unfunded mandate"?  What about the commonly expected best practice of physicians washing their hands between patients?  These are things we do in the healthcare community to protect patients, physicians, and other stakeholders from the unintended consequences of case delivery.  I can't understand how that logic trail doesn't extend to prescribing opioids. 

Texas doctors, or appropriate physician-extenders, should be required (as they are in Kentucky, for example) to check the PDM database prior to writing a script for a schedule II narcotic. 

I know that will cost the docs money.  But if they don't do it, it might cost lives. 

Michael
On Twitter @PRIUM1