New report shows growing off-label narcotic use in California's comp system

Buccal Fentanyl is not approved by the U.S. Food and Drug Administration for musculoskeletal injuries. Yet, a new study shows it's being prescribed for dozens of injured workers with minor back pain in California.

Part 2 of the California Workers' Compensation Institute's study on Prescribing Patterns of Schedule II Opioids focuses on the use of fentanyl in the California workers' comp system. The data sample was obtained from pharmacy bills contributed by pharmacy benefit management organizations with injury dates between January 1993 and December 2009.

Fentanyl can be administered intravenously as a skin patch or as a lozenge or effervescent tablet. The prescriptions in the study included those prescribed as a skin patch or orally.

While the FDA has issued various warnings about the drug over the past years, there was a particular warning in 2007 about Buccal Fentanyl, also called Actiq lozenges or Fentora effervescent tablets.

"Buccal Fentanyl should be used only to treat breakthrough cancer pain . . . in cancer patients who are taking regularly scheduled doses of another narcotic (opioid) pain medication and who are tolerant (used to the effects of the medication) to narcotic pain medications," the FDA said. "This medication should not be used to treat pain other than chronic cancer pain."

Despite that warning, CWCI reports more than 14 percent of claims with minor back injury had at least one prescription for Actiq or Fentora. "There was no evidence of cancer-related illness or injury among any of the injured workers in the study sample, indicating that off-label use of fentanyl lozenges or tablets, which are only FDA approved for breakthrough, chronic cancer pain, has become an issue in the California system," the report states.

The use of off-label narcotics is not restricted to California. Nor is it a small problem in the workers' comp system.

"I'd argue from a medical management standpoint it's the most significant problem we have," said Joe Paduda, principal of Health Strategy Associates and author of the blog, Managed Care Matters. "It's not just that they cost a lot of money -- they do; but there's ample evidence to suggest the use of narcotic opioids for an extended period of time to treat musculoskeletal injuries is contraindicated."

In addition to the cost -- about $3,000 to $4,000 a month -- Paduda says the off-label use of these drugs to treat minor injuries creates a plethora of other problems. "There are side effects, such as sexual dysfunction, constipation, and sleeplessness," he said. "So people need other medications to deal with the side effects."

Additionally, there are risks of addiction as well as abuse or diversion of the drugs. Finally, there's the risk of death.

"Opioids slow down the respiration rate," Paduda explained. "You build up a tolerance for a certain dose, but your body doesn't build up the pulmonary tolerance. People go to sleep and die."

The question of how to address the growing issue of narcotics -- especially off-label use -- in the workers' comp system is starting to be addressed by several states. Washington, for example, has established policies and practice guidelines for physicians who prescribe Schedule II narcotics.

"I think there's a growing recognition on the part of state regulators and legislators that they've got to solve this problem," Paduda said.

Read more at the WorkersComp Forum homepage.

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Self-Insured Numbers Higher Than Expected, and Growing

A new report reveals that the federal government was underestimating the number of employers that self-fund employee health benefits. Now, with healthcare reform, their numbers are set to grow.
By JULIE LIEDMAN, a freelance writer who lives in Philadelphia
On March 23, the one-year anniversary of the Patient Protection and Affordable Care Act (PPACA), the U.S. Department of Labor issued its first annual report on self-insured employee health benefits plans, mandated by the legislation.
One important aspect of the report for self-insured employers was what it omitted: Nowhere did the report claim that self-insured employers are more likely to have problems funding their plans than employers that fully fund their health benefits plan through traditional health insurance.
According to the DOL report, about 12,000 health plans filing a Form 5500 for 2008--the latest year for which complete data is are available--were self-insured, and 5,000 mixed self-insurance with insurance. Self-insured plans covered 22 million people, while mixed plans covered 25 million. Health benefits plans covering private-sector employees must file the form if they cover 100 or more participants or hold assets in trust. Because many self-insured health plans do not meet the filing requirements and therefore haven't filed the form, however, the total number of self-insured plans probably is underestimated. The DOL report acknowledged this, another success for the self-funding marketplace.
What's more, that number might be growing. Healthcare reform could make self-insurance more attractive to many companies, according to one of the nation's biggest self-insurance industry trade groups.
"We expect a larger interest in self-insurance than ever before when additional regulations such as exchanges, 'pay-or-play' and vouchers go into effect (by 2014)," said Mike Ferguson, chief operating officer of the Self-Insurance Institute of America.
By 2014, PPACA requires that health insurance be more affordable and easier to purchase for small businesses and individuals through statewide exchanges. Employers with 50 or more full-time employees must either provide specified minimum levels of coverage to their employees or pay an excise tax. This is referred to as "pay or play."
Employers who offer more than the minimum must provide a "free choice voucher" to certain eligible employees. For every such voucher the employer provides to an employee who qualifies, the employer will be required to pay the exchange where the employee uses the voucher to purchase coverage for an amount equal to the portion of the monthly cost of coverage that the employer would have paid.
Smaller employers may find it financially advantageous to pay for their own firm's risk than to be subject to the new provisions.
Purchasing a plan through the exchange, for instance, where premiums will be a function of the broader risk pool and subject to risk adjustment, could be costly, Ferguson said. If enough small firms with healthier enrollees opt out of a state's small-group market in 2014, that state exchange could experience adverse selection.
"Based on anecdotal feedback we've gotten from our members," said Ferguson, "they've digested the regulations currently in place, adapted to any new requirements and life goes on."
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