Keep on Fighting The Good Fight: Compound Creams

For years, workers’ compensation adjusters, nurse case managers, and other workers’ compensation professionals sounded the alarm about physicians using opioids as a cure-all for alleged chronic pain. Significant progress has been made with this issue. Large pharmaceutical companies like Purdue Pharma are currently being sued by at least 44 states related their role in fueling and sustaining the opioid crisis. Now, it is almost universally accepted within the workers’ compensation community that prescribing opioids for chronic pain is only recommended after careful consideration of the risks and benefits associated with long-term opioid use for each patient.

Unfortunately, we are seeing another similar trend that is driving up claim costs and providing questionable benefit for patients: topical compound creams. As many of you know, topical compound creams can cost anywhere from $500.00 – $5,000.00 per month, depending on manufacturer and the ingredients. With such a hefty price tag, one would hope that it was a well-researched field with abundant evidence of benefit to the patient. That is not the case.

The Defense Health Agency (Walter Reed Medical Center) put out a paper on February 1, 2019 following a study into the effectiveness of compound creams used for chronic pain. It was published in the Annals of Internal Medicine, which is a reputable journal. The study had 399 patients (a relatively small sample size) and they were separated into categories of neuropathic pain, nociceptive pain or mixed pain. They studied commonly used compound creams vs. placebo for effectiveness over one month. The conclusion was that “compounded pain creams were not better than placebo creams, and their higher costs compared with approved compounds should curtail routine use.”

An employer and carrier can only be held responsible for medical treatment that is reasonable, necessary, and causally-related to a work accident. Many of the pain creams currently being prescribed in Virginia have not been approved for topical use. In any case where a physician prescribes pain cream, the case should be carefully monitored to make sure the prescribing physician can justify use of the compound cream.

Just like the opioid crisis, there will be challenges associated with questioning the basis for compound cream prescriptions. In Virginia, the opinion of the treating physician is entitled to great weight. Thus, if the treating physician says that the cream is necessary, you will likely be held responsible for authorization and payment absent compelling secured evidence to the contrary.

For example, in 2018, the Full Commission held that use of pain cream recommended by a patient’s treating physician was reasonable, even though: (a) the treating physician admitted that the claimant’s reported improvement might have been due to a placebo effect, rather than the compound cream itself; (b) use of the compound cream had not eliminated the patient’s need to take other pain medication; (c) an IME physician noted that the main compound ingredient had “limited known human application…no proven topical use, or dosage recommendations in that application in humans” and was “without scientific validity which supports their use”; and (d) a records review physician concluded that use of the compound cream was not reasonable or necessary. Hatcher v. Go Mart, Inc., JCN VA00001099600 (Feb. 20, 2018).

In cases where a compound cream is being prescribed, some of the following questions may be helpful in determining whether to challenge the reasonableness of prescribing a compound cream for a particular patient:

1. Does the compound cream contain ingredients that have been approved by the FDA for topical use?
2. Has use of the compound cream resulted in reduction in use of other oral medications?
3. Has use of the compound cream resulted in substantial pain or symptom reduction?
4. Has use of the compound cream resulted in actual functional improvement?

If the answer to any of these questions is “no” it may be time to schedule a telephone call with the prescribing physician, obtain a second opinion, or take the doctor’s deposition. It is important to carefully and effectively develop your case to counter any opinion of a treating physician if you wish to prevail on a dispute over compound cream.

It may take years for the whole industry to pay attention to the risks of prescribing costly compound creams without scientific evidence, but taking these steps in your case might help achieve the right outcome for the patient, while reducing claim costs.

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