MSP Compliance Blog

Additional MRI States that follow the Official Disability Guidelines (ODG) do not need to authorize an additional MRI
unless there are specific changes in pathology.
The ODG states that ³MRI¹s are test of choice for patients with prior back surgery,
but for uncomplicated low back pain, with radiculopathy, not recommended until after at least one month conservative therapy,
sooner if severe or progressive neurologic deficit. Repeat MRI is not routinely recommended,
and should be reserved for a significant change in symptoms and/or findings suggestive of significant pathology
(eg, tumor, infection, fracture, neurocompression, recurrent disc herniation).² (Bigos, 1999) (Mullin, 2000)
(ACR, 2000) (AAN, 1994) (Aetna, 2004) (Airaksinen, 2006) (Chou, 2007)

The Centers for Medicare and Medicaid (CMS) issued a new memorandum that will affect pricing determinations for TENS (Transcutaneous Electrical Nerve Stimulation) units for the treatment of Chronic Low Back Pain (CLBP) included within the Workers’ Compensation Medicare Set-Aside (WCMSA) that have been submitted to CMS for approval.

On June 8, 2012, CMS issued a new Decision Memo that defined CLBP as “an episode of low back pain that has persisted for three months or longer; and is not a manifestation of a clearly defined and generally recognizable primary disease entity.” CMS further stated that a TENS unit was not “reasonable and necessary for the treatment of CLBP under section 1862(a)(1)(A) of the Social Security Act.”

TENS is the use of stimulating pulses across the surface of the skin produced by a device to stimulate the nerves for therapeutic purposes. TENS help stimulate your body to produce higher levels of Endorphins. The TENS units are small, battery operated devices that deliver these stimulating pulses across the surface of the skin. It has been an ongoing dispute over the years as to whether TENS units do more than act like placebo’s, and whether they actually treat and cure CLBP.

CMSs New Pricing Determination will affect the WCMSA’s proposal as follows:

1. Workers’ Compensation cases settled prior to June 8, 2012:

   “For those Workers’ Compensation cases settled prior to June 8, 2012, and where the settlement included pricing for TENS for CLBP, CMS will consider funds spent for TENS for CLBP by beneficiaries and claimants as being an appropriate expenditure of funds as part of the WCMSA.”

2. Workers’ Compensation Cases Settled After June 8, 2012:

   “For those Workers’ Compensation cases that were not settled prior to June 8, 2012, and where the WCMSAs proposal includes funding for TENS for CLBP as part of the WCMSA, CMS will re-review the cases and remove pricing for TENS for CLBP. (Regional Offices shall obtain from Submitters requests for a case re-review, along with a signed statement indicating a settlement had not occurred prior to June 8, 2012.)”

It is important to note that in the event CMS does re-review a WCMSA for removal of a TENS unit for CLBP, the claimant may NOT use the funds from their WCMSA to pay for the TENS for CLBP. If a claimant uses the funds for the TENS, this would result in an inappropriate expenditure of funds.

For additional questions on the use of TENS units as treatment for chronic low back pain, and its implications on future medical treatment and the WCMSA, please contact Tower MSA Partners at 888-331-4941 or email us at info@towermsa.com. For the full text of the CMS Decision Memo, see Decision Memo for Transcutaneous Electrical Nerve Stimulation (TENS).

To those who may not know, PROP (Physicians for Responsible Opioid Prescribing) http://www.supportprop.org/ is an organization comprised of practicing physicians whose mission is “to reduce morbidity and mortality resulting from prescribing of opioids, and to promote cautious, safe and responsible opioid prescribing practices.”   I follow PROP regularly and use many of their resources to educate my staff on opioid use as it relates to long term prescribing and the MSA.

As a PROP follower, I recently received the email below asking for my support.  I responded immediately and am forwarding to each of you in the hope that you will do the same.

 

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Dear Friends and Colleagues,

As you may know, PROP filed a request to FDA for changes to opioid labels. Specifically, we asked them to add a suggested duration of use, a suggested upper dose and to limit (on-label) use to severe pain. You can read about this here:  http://supportprop.org/advocacy/index.html.

If FDA implements our request, opioid manufacturers will be prohibited from advertising long-term use of opioids for chronic non-cancer pain and the medical community will be informed that this practice has not been proven safe and effective. (However, clinicians will still be permitted to prescribe long-term opioids). We believe that this will help reduce overprescribing of opioids. And since it’s overprescribing that’s harming pain patients and fueling the opioid addiction epidemic, the label change could help bring this unprecedented public health crisis under control.

FDA is seeking public comment about the Petition. Thus far, they have received about 200 comments supporting the petition and 130 opposed to the petition. Not surprisingly, industry-funded pain groups (and pain patients misled to believe that this is an effort to ban opioids) have weighed in against the Petition.

Submitting comments to FDA is easy… just click here: http://www.regulations.gov/#!submitComment;D=FDA-2012-P-0818-0001.

A couple of sentences is all you need. Please make sure to state clearly in the first or second sentence that you support the petition.

For example, you can write:

I support this petition. Drug companies should not be permitted to advertise long-term and high dose opioids for moderate chronic pain because this treatment has not been proven safe and effective. The medical community should be informed by a revised label that risks may outweigh benefits when opioids are prescribed long-term.

Please try to do this ASAP. As soon as FDA takes an action on the Petition (which could be very soon), they will close the comment period.

If you are interested in reading comments that have already been posted, you can do this here:
http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=fda-2012-p-0818.

Thank you for your support!

Andrew

Andrew Kolodny, MD
President, Physicians for Responsible Opioid Prescribing
www.supportPROP.org

Chair, Department of Psychiatry
Maimonides Medical Center
920 48th St., Brooklyn, NY 11219
Tel: 718 283-7557; Fax: 718 283-6540
akolodny@maimonidesmed.org

The over-prescribing of opioids and subsequent problems of addiction, overdose and even death is a public health crisis that has dramatically impacted workers’ compensation. A startling 55 to 85 percent of injured workers receive narcotics for chronic pain.

A recent study by Accident Fund Holdings and Johns Hopkins University examined the interrelationship between the utilization of short- and long-acting opioid medications and the likelihood of claim cost escalating to a catastrophic level (> $100,000). Analyzing 12,000 workers’ compensation claims in Michigan during a four-year period, the study focused on whether the presence of opioids alone accounted for the cost increase or whether costs increased because opioids were associated with known cost-drivers, such as legal involvement and injury severity.

Controlling for factors of sex, age, time lost from work, number of distinct ICD-9 codes per claims and legal involvement, results showed that opioid use – particularly of long-acting (LA) opioids – was an independent predictor of catastrophic claims costs.  Key findings:

• The presence of LA opioids makes claims almost 3.9 times more likely to have a final cost of >$100,000 than a claim without any prescriptions.
• Claims with only short acting (SA) opioids were 1.76 times more likely to have an ultimate claims cost of >$100,000.
• Claims with non-opioid prescriptions showed no significant risk of exceeding $100,000 int total claim cost.

When assessing the price of opioid medication as it related to total medical and overall claim cost, the study found that the price of the drug itself was a minor contributor to the overall medical or total claims cost. SA opioids represented 0.3 percent of overall medical cost and 0.1 percent of overall claim cost, while LA opioids were approximately 3 percent of medical and 1.2 percent of total claim cost.

Strategies to Mitigate the Impact of Opioids

In the context of such clear and objective evidence that the use of opioid medications, particularly long-acting opioid medications, is an independent risk factor for the development of catastrophic claims, how do we now view the costs associated with proactively addressing addiction issues? Are cognitive behavioral and rehabilitation programs more reasonable strategies in light of these findings? How do we mitigate cost, facilitate settlement and provide better care?

The study’s findings reinforced Accident Fund’s decision to increase medical management on claims with opioids. “Our strategy consists of three elements: early detection, intervention and escalation,” said Jeffrey Austin White, MS, the study’s lead researcher and Accident Fund Holdings’ Director of Medical Management Practices and Strategy. “Leveraging technology solutions to identify opioid risk factors as soon as possible, establishing peer-to-peer intervention strategies based on case-specific needs and escalating internal workflows when specific triggers are met have improved patient outcomes and reduced costs.”

Applying Lessons Learned to Pre-Settlement Workflow

We at Tower MSA Partners applaud Accident Fund’s pro-active, enterprise-level approach to address opioid overutilization and applaud its success. We also recognize that the industry needs state-level pain guidelines. “Statutory support would provide a more comprehensive and general solution for managing opioid claims, until then, every opioid claim seems to require an individual approach with no guarantees,” White added.

Until states provide leadership through regulatory reform, what can payers do? While pain management is necessary, the abuse of opioids can cause hazardous, life-threatening side effects — for which payers may be held responsible.

PBM reports that identify chronic opioid use are available. Yet how do we get the appropriate information into the hands of those who can – and will – act on it? What is the appropriate action to take for each claimant? Are there jurisdictional requirements to meet when intervention is warranted? When (and by whom) should contact be made to the treating physician? How do we get treating physicians to modify drug therapy? Who follows through to verify that the drug regimen actually changes?

These are questions Tower MSA Partners addresses daily as part of its Pre-MSA Settlement Services. We work with clients to “stage” claims for settlement as early as possible. We define intervention triggers, initiate peer-to-peer contact with the treating physician when triggers are met, and obtain written agreement when treatment changes are approved. Most importantly, we stay involved to make certain positive outcomes are achieved. For information on the Accident Fund/Johns Hopkins study, “The Effects of Opioid Use on Workers’ Compensation Claim Cost in the State of Michigan,” please go to http://journals.lww.com/joem/Abstract/2012/08000/The_Effect_of_Opioid_Use_on_Workers__Compensation.8.aspx (subscription required.) For more information on Tower MSA Partners’ Pre-MSA Settlement Services, contact us at info@towermsa.com.

On July 19, WCRI (Workers’ Compensation Research Institute)  released its most recent study on the rapid growth of physician-dispensed pharmaceuticals for injured workers under state workers’ compensation.   The study compares 23 states, including Arkansas, Connecticut, Florida, Illinois, Indiana, Iowa, Louisiana, Maryland, Michigan, Minnesota, New Jersey, North Carolina, Pennsylvania, Virginia, and Wisconsin highlighting changes in patterns of dispensing, as well as changes in percent of market and pricing from 2007/2008 thru 2010/2011.

Increases in Frequency and Cost for Physician Dispensed Drugs

Key findings in WCRI’s study year over year include the following:

1. Physician-dispensed drugs became increasingly common in most states that permit physician dispensing.   In Florida, Illinois, pre-reform Georgia, Maryland, Connecticut and post-reform Arizona and California, physicians dispensed 28-53 percent of all prescriptions, representing 28-63 percent of total spending on workers’ compensation claims.
2. Prices paid for physician-dispensed drugs were substantially higher than if the same drugs were dispensed by a retail pharmacy.  In 2010/2011, the price / pill when dispensed by a physician was 60-300 percent higher than the same prescriptions dispensed at a retail pharmacy.
3. Prices paid to dispensing physicians rose rapidly for medications that were commonly dispensed by physicians, while the prices paid to pharmacies for the same drugs changed little or fell.  As an example, Physician dispensed Vicodin, Mobic and Ultram, all commonly prescrbed in workers’ compensation, saw a average price increase of 52 percent while the same drugs dispensed in a retail pharmacy setting either remained at the same price or experienced a price decrease.
4. Dispensing physicians wrote prescriptions for and dispensed certain drugs (e.g., omeprazole [Prilosec®] and ranitidine HCL [Zantac®]) that are available without a prescription in a drug or grocery store at a much lower price.   When they did so, prices were 5-15 times higher than MSP retail prices.

With this trend of increased price and frequency of physician dispensed drugs , it is no surprise that several states have either banned the practice altogether, have initiatives in place to limit or prohibit, or are in the process of implementing reforms directed at reducing the cost of physician dispensing. The study examined the results of specific state initiatives, as well as highlighting baseline data for states with legislation currently in play.

States That Prohibit Physician Dispensing

In the United States, five states have prohibited physicians from dispensing drugs in general, by law.  These include Massachusetts, New York, Texas and Montana and Utah.  The first three are included in the study.  In all other states, issues related to physician dispenisng are more or less addressed through state workers’ compensation policies on state fee schedules, which set maximum reimbursement rates for prescrption drugs dispensed at pharmacies and physician offices.

Where Physician Dispensing is ‘Allowed’

Several states allow physician dispensing, but in some states, such as Arkansas and Minnesota, medical practices appear to be restrictive.  Arkansas, physician dispensed drugs are subject to the same fee schedule as pharmacy dispensed drugs. In both settings, the provider (whether pharmacist or physician) is required to report acquisition cost, and physicians do not receive a dispensing fee for drugs dispensed from their offices.  In Minnesota, physicians are allowed to dispense, but must register with the Medical Practices Board before doing so.  The physician must also disclose to the patient that the he/she profits from the dispensing of medications, and that the patient may choose to obtain  prescriptions from another source.

Louisiana limits physician dispensing of narcotics to a 48-hour supply, but allows for non-narcotic drugs to be physician dispensed for longer periods.  In Florida, as of June, 2011, physicians are prohibited from dispensing Schedule II and Schedule III narcotics.

Five states (Arizona, California, Tennessee, South Carolina and Georgia), allow physician dispensing, but have adopted reforms intended to limit the price markups for physician dispensed prescriptions.  Also, in Illinois, one of the largest noted in the study for cost increases associated with physician dispensing, the Workers’ Compensation Commission members voted Tuesday, July 24, 2012,  to move ahead with a proposed rule to regulate the price of repackaged drugs, dispite a recommendation by the Medical Fee Advisory Board not to proceed.  For the rest of the states, policies are either permissive or silent as they relate to physician dispensing.

In the state of Florida, while physician dispensing is prohibited for Schedule II and Schedule III narcotics as of June, 2011, the study still showed that 62 percent of all prescription drug spending in  Florida for injured workers was paid to physicians for drugs dispensed at their  offices—not to pharmacies.  This doesn’t mean 62 percent of all prescriptions….just 62 percent of the cost.  That’s the issue.

Certain drugs were prescribed and dispensed by physicians in Florida that were  infrequently prescribed in other states where physician dispensing was not  common. For example, 11 percent of the injured workers in Florida received  prescriptions for either Prilosec® or Zantac® as compared to less than 2 percent  in most other states. When physicians dispensed, the average price paid per pill  was $7.07 for Prilosec® and $4.81 for Zantac®, compared to $0.64 and $0.42 per  pill when the same drug was purchased over-the-counter at Walgreens.

In other states that allow physician dispensing of all prescriptions, as a  result of drug repackaging, prices paid to physicians were  typically much higher than what was paid to pharmacies for the same drug. For  example, the price for the most commonly used drug, Vicodin®, more than doubled  when dispensed by physicians compared to the pharmacy—an average of $1.08 per  pill at the physicians’ offices versus $0.43 at the pharmacy.

“There is a great discrepancy between what doctors and pharmacies charge for  dispensing the same drug,” observed Dr. Richard Victor, WCRI’s Executive  Director. “One question for policymakers is whether the large price difference  paid when physicians dispense is justified by the benefits of physician  dispensing. Policymakers can learn from the California reform experience, which  is also analyzed in this study.”

Pricing at WC Fee Schedule – Lessons Learned in California

One of the key findings of the report, the results of the California fee schedule reforms (physicians who dispensed were required to submit and price using the same NDC  as that used in retail pharmacies), provided evidence of the impact of physician dispensing on the following:

1. Prices paid for physician-dispensed prescriptions;
2. Patient access to physician-dispensed prescriptions;
3. Physician prescribing and dispensing patterns for certain drugs.

Approximately 1/2 of all drugs dispensed in CA remain as physician dispensed.  Following fee schedule reforms, however, the number of repackaged drugs dispensed in CA dropped from 43 percent to 11 percent.   In effect, the average price / pill for physician-dispensed prescriptions decreased to that for pharmacy-dispensed prescriptions.

State Initiatives to Control Growth and Manage Cost

States that have either implemented reforms similar to that of California over the past year, or have bills under debate currently include Arizona, California, Georgia, South Carolina, and Tennessee.  While the results of the legislative initiatives remain to be seen, California’s track record would lead us to believe that savings are possible if physicians are required to follow the same rules as their retail pharmacy counterparts when dispensing medications.

Impact on WCMSA Part D Cost Projection for Life Expectancy

As is the case in California and the other five states with reform initiatives onteh books, when physicians prescribe and dispense using the standard National Drug Code (NDC), pricing will occur at fee schedule or lower (if negotiated discounts are available).  From an MSA perspective, therefore, there are no objections to physician dispensing.  CMS Memos direct us to price at generic when available.   As such, when Tower identifies standard, commonly prescribed drugs being physician dispensed, we utilize the GCN (Generic Code Number) to determine therapeutic equivalency.  We then price at the lowest generic price available.

The Real Problem – Repackaging – Not Physician Dispensing

While physician dispensing is getting criticized, I would clarify that it is the process of repackaging medications that can be bought at much lower prices, and the egregious cost associated with repackaging, that is the real problem.  Many physicians, some who dispense, and others who do not, comment that the physicians aren’t the ones making money….it is the re-packagers that are making out ‘like bandits’.   While this may be true, it’s difficult to see how smart, educated physicians would continue this practice and the associated criticism if they aren’t making a nice profit.

 Potential Strategies to Mitigate Cost

The first step to mitigate claim cost is to be aware of physician dispensing and to move quickly to verify what the actual drug is.  Tower MSA Partners has full access to CMS mandated REDBOOK for drug pricing for all FDA approved NDC’s, as well as access to generic therapeutic equivalent drugs if they exist.   Ask the question.  Once you know what is being dispensed, and you understand the role the drug/compound plays in the overall treatment of the injury, the next question is whether intervention is appropriate to modify treatment and hopefully reduce cost.  We can assist there as well to make recommendations for nurse oversight, physician reviews. etc.

WCRI’s announcement of the report can be found at  http://www.wcrinet.org/whats_new.html.   For more information on physician dispensing and ‘staging’ claims to reduce claim cost , and to mitigate settlement and MSA issues, give us a call at 888-331-4941.