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Concerns about perceived ambiguity in the review process for non-preferred drugs and the lack of inclusion of opioids on the list of preferred, evidence-based medications are some of the reasons major stakeholders in the workers comp space are calling for delayed implementation of California’s drug formulary.
The deadline for public comments was May 1, leaving the California Department of Industrial Relations sifting through 119 pages of feedback from nearly two dozen separate organizations and stakeholders as regulators prepare to implement a drug formulary for injured workers.
In 2015, California lawmakers passed Assembly Bill 1124, which establishes an evidence-based closed drug formulary by July 1, 2017. Closed formularies limit approved medications for workers comp claims, and prior to the new law, California legislators had carefully examined closed formularies in Texas and Washington state.
Closed drug formularies have been lauded as a way to curb opioid prescribing and many public commentators praised California’s tackling of an issue that has plagued the workers comp system, but not without criticism.
To manage pain, the proposed formulary gives preference to anti-inflammatory drugs over stronger, more addictive opioids. However, three of them — Percocet, Vicodin and morphine — can be prescribed for four days within seven days of an injury, but no more without a review, which several commentators found too restrictive.
“The formulary remains overly restrictive and unencompassing,” said Danielle Jaffe, an attorney and manager of government affairs for Methuen, Massachusetts-based Injured Workers Pharmacy L.L.C., a mail-order prescription service, adding that not only are pain medications limited, but so are muscle relaxants and antidepressants.
“Of the listed 242 prescription drugs in the formulary, only 76 are considered preferred,” Ms. Jaffe said in her public comments. “When the formulary is applied to our experience within California, of our 30 most dispensed medications, only 10 are preferred, 13 are non-preferred and 7 are not even listed. The fact that the list of non-covered prescriptions is so lengthy raises concerns that the draft formulary did not properly account for common workers compensation injuries and their treatment.”
The use of the terms “non-preferred” also raised an issue for the San Francisco-based Western Occupational & Environmental Medical Association.
“We are concerned that designation of many medications as ‘non-preferred’ may be misinterpreted by some payers as meaning ‘should be denied,’ when in fact many such drugs may be useful or even critical in some situations,” Dr. Robert Blink, president of the organization, said in his comments.
Another concern is the “ambiguity” in the language of the formulary, according to Michael Gavin, president of the Duluth, Georgia-based medical cost management firm Prium, who referred to this section of the formulary in his letter: “For injuries occurring prior to July 1, 2017, the … drug formulary should be phased in to ensure that injured workers who are receiving ongoing drug treatment are not harmed by an abrupt change to the course of treatment.”
Mr. Gavin said it is unclear what the directive is. “There are ambiguous terms used throughout this paragraph that will lead to confusion amongst stakeholders and will require litigation to resolve the ambiguity,” he said in his comments. “Ambiguous terms should be either defined or eliminated to avoid confusion. Preferably, the ambiguous terms would be replaced with more instructive language that offers clear expectations to the stakeholders involved.”
Regulators released a statement in March promising to review the feedback and, pending revisions to the formulary, open another 15-day public comments period. This raised a top concern mentioned in several written comments about the unknown timeframe between the formal adoption of the formulary and the day it must be implemented.
“The short time frame between formal adoption and the proposed effective date does not allow sufficient time for adequate communication to various stakeholders, including treating physicians,” said Brian Allen, vice president of government affairs for Eden Prairie, Minnesota-based Optum Workers’ Comp and No-Fault Insurance, in his comments requesting that implementation be delayed by 60 to 90 days. “Early success with other state-mandated formularies was premised on an extensive educational campaign targeted to physicians and pharmacists treating injured workers who are most impacted by the change. Absent that educational component, the application of the formulary could create unnecessary delays in approved pharmacy care getting to injured workers.”
Optum is not the only industry leader calling for a delay. St. Louis, Missouri-based Express Scripts Holding Co., in its public comments letter, requested implementation to be postponed to Jan. 1, 2018 “to ensure all system participants are prepared and educated on the formulary drug regulations and allowing the required time for system enhancements or process changes necessary for a successful implementation.”
The Arkansas Workers' Compensation Commission has scheduled a public hearing for May 23 as it considers adopting a drug formulary that would require preauthorization for opioid prescriptions and pose fill limits for such addictive pain medication.