08 Jan 2015

WCRI Study Strikes Serious Blow to Physician-Dispensed Strong Opioids

A significant proportion of physician-dispensed strong opioids may not have been necessary at all

Thomas A. Robinson, J.D., the Feature National Columnist for the LexisNexis Workers’ Compensation eNewsletter, is a leading commentator and expert on the law of workers’ compensation.

A new study published by Workers’ Compensation Research Institute (WCRI) strongly supports the contention of many experts that prior to Florida’s ban on physician dispensing of Schedule II and Schedule III controlled substances, which went into effect on July 1, 2011, a significant proportion of these physician-dispensed strong opioids may not have been necessary. [See Thumula, V., “The Impact of Physician Dispensing on Opioid Use,” (WC–14–56) December 2014.] According to the report, the 2011 ban on physician dispensing of strong opioids reduced the percentage of injured workers in Florida who received strong opioids during the first 12 months after injury from 15.6 percent to 13.7 percent—a 12 percent reduction. The WCRI study noted the reduction was due to a drop in physician-dispensed strong opioids with no material increase in pharmacy-dispensed strong opioids. The study data indicates that rather than continuing to prescribe strong opioids for patients that would be filled at local pharmacies, many Florida physicians continued the practice of prescribing and supplying physician-dispensed drugs, replacing the strong opioids with weaker opioids and nonsteroidal anti-inflammatory drugs (NSAIDs), begging the question of whether many of the strong opioid prescriptions in Florida were necessary at all.

While the study analyzes Florida data only, its findings provide important insights for stakeholders in other states where physician dispensing is common. Those desiring to learn more about the study or to purchase a copy should check the following URL: http://www.wcrinet.org/result/PD_opioid_result.html.

The Florida “Pill Mill” Problem and the 2011 “Reforms”

As the WCRI study notes, the vast majority of states allow physician dispensing. Only Massachusetts, New York, Texas, Montana, Utah, Wyoming and, since mid–2011, Florida prohibit or severely restrict the practice. For years, the high incidence of opioid use in Florida had caused concern. Critics complained that “pill mills”—pain management clinics that prescribe medications to persons without requiring thorough physical examinations, x-rays or medical records—were pervasive and that the damage done to patients—particularly injured workers—was considerable. The data was damning. According to a 2013 DEA report, for calendar year 2010—the last year before the “reforms” contained in Florida House Bill (HB) 7095 took effect—90 of the top 100 oxycodone-purchasing physicians in the United States were located in the Sunshine State [Retrieved from http://www.justice.gov/dea/divisions/mia/2013/mia040513.shtml (accessed January 3, 2014)]. By 2012, the number had dropped to zero.

HB 7095, effective July 1, 2011, largely banned the dispensing of Schedule II and Schedule III opioids by physicians. Now, if physicians deem the strong opioids to be medically necessary, they can, of course, still continue to prescribe them; the patient is expected, however, to fill the prescription at a pharmacy. There are a few exceptions to the ban. Physicians may dispense strong opioids:

1. For up to a two-week supply within 14 days following certain surgical procedures;

2. As drug samples for free; and

3. In certain settings, including clinical trials, hospice care, and medical centers in the department of corrections.

Violation of the ban is considered a third-degree felony and can lead to suspension of license to practice for at least six months. There were no new limits on dispensing of other medications by physicians in Florida.

The WCRI Study Examining Physician-Dispensing of Strong Opioids

The study analyzed data on medications dispensed for injured workers covered by Florida’s workers’ compensation program, including both open and closed claims, with dates of injury from January 1, 2010, to June 30, 2010 (prior to the effective date of the ban) and post-reform, with dates of injury from July 1, 2011, to December 30, 2011 (immediately after the ban). Prescription utilization of each worker was observed for 12 months following the date of the injury. To analyze the impact of the ban on the prescribing practices of physician-dispensers, Dr. Thumula examined prescriptions filled up to six months after the effective date of the ban. To analyze whether or not, after the ban, those who received weaker pain medications from physician-dispensers also received strong opioids from pharmacies, she examined prescriptions filled by those workers for an additional six months. The data included 24,567 claims with 59,564 prescriptions in the pre-reform group and 21,625 claims with 52,747 prescriptions in the post-reform group.

Study Findings

Among other things, the study found:

> There was a high level of compliance with the ban on physician-dispensing of strong opioids.

> Not only did physician-dispensers significantly reduce the level of dispensing strong opioids, they also reduced the prescribing of those medications. As noted in the study, this raises concerns that a significant proportion of pre-reform physician-dispensed strong opioids may not have been necessary.

> There was no significant increase in the number of workers receiving strong opioids at pharmacies. As noted above, HB 7095 placed no restrictions on prescribing strong opioids, so long as the prescriptions were filled at a pharmacy, rather than at the prescriber’s facility. If the number of pre-ban prescriptions was actually necessary, one would have expected the number of prescriptions filled at pharmacies to tick up dramatically. This did not occur.

> The data suggests physician-dispensing of pain medications continued; the dispensing switched, however, from strong opioids to weaker opioids and NSAIDs.

Limitations

The study identifies two limitations. First, WCRI’s study draws inferences about the “average” physician-dispensing provider. It is possible, says Dr. Thumula, that the change in prescribing and dispensing patterns observed (i.e., substituting strong opioids with other pain medications not subject to the ban) could have been driven by a small subset of dispensing physicians who were dispensing strong opioids pre-reform. Second, there might be a “confounding” effect caused by other Florida reforms that came into effect shortly after the ban on physician dispensing. Thumula posits that such other reforms probably did not, however, have a material impact on the study findings since the major findings are consistent with earlier related studies.

Study’s Implications

The WCRI study has important implications that reach well beyond Florida. For example:

1. The study notes that over the past 10 years, some 18 states have modified reimbursement rules to reduce the price paid for physician-dispensed drugs, yet the study findings raise the core question as to whether state policymakers should concentrate instead on reforms that limit the use of physician dispensing of certain medications rather than aim policy decisions at limiting the prices of physician-dispensed drugs.

2. While opponents of policies limiting physician-dispensing of medications such as strong opioids argue that such “reform” legislation merely changes the location at which the prescriptions are filled, the WCRI study directly contradicts that position. In fact, the study raises concerns that many of the strong opioids dispensed by physicians were unnecessary prior to their ban in Florida. Since other studies have found that workers with physician-dispensed repackaged drugs had higher claim costs and experienced more work loss compared with workers without these drugs, the real result of the ban may be to reduce costs and enhance injured worker medical care.

3. The study raises the possibility that physician self-referral raises costs throughout the larger health care system. Other studies have shown that surgeons who own surgery centers do more surgeries, that self-referring physicians initiated more physical therapy, and that that physicians that owned magnetic resonance imaging (MRI) machines ordered more “medically inappropriate” MRIs.

What’s Ahead?

The WCRI study will test the power of the physician-dispensing lobbies in other states. Those who tout the practice as providing convenience and benefit to patients must now wrestle with this WCRI study that supports the argument that a significant segment within the medical community seems actually more concerned with its own bottom line.