Zohydro, and Closed Formularies

Friday, December 13, 2013 | 0

In Florida, workers get injured, employer/carriers' pick the doctors, and those physicians recommend and provide the medical care. This is not the paradigm in all jurisdictions across the country. There are "patient choice" jurisdictions in which the injured worker has more control of physician choice. So, control is a distinction between jurisdictions.

Recently, another control issue has seen a resurgence in Comp. Texas is a "closed formulary" state. The treating physician in Texas is limited regarding the medication she/he can prescribe in many workers' compensation cases. This is nothing new necessarily, closed formulary was an integral element of managed care, a solution championed and then enacted in a variety of jurisdictions in the 1990s, including right here in Florida.

The concept is simple enough. A list of presumptive "acceptable" medications is adopted, and treating physicians have reasonably free reign to prescribe those. If the physician wants to prescribe something that is not on the formulary list there will be paperwork to complete and justifications to describe. This is not uncommon, it is a tool used by both Medicare and Medicaide. Some estimate that as many as one-third of insured Americans are involved in some form of closed formulary control or restrictions regarding their group health coverage.

Closed formulary undoubtedly results in some frustrations for the patient and the physician. This is true whenever regulation interferes with unfettered interaction between doctor and patient. There are a multitude of such regulations in the delivery of American health care, preauthorizations, restrictions to plan providers, etc.

There are also some benefits to the closed formulary. Those that pay for medical care, the employer/carriers in workers' compensation and the health insurers in the broader health insurance context, gain a familiarity with the formulary medications and compounds. The universe of prescribed medications is smaller under these plans and therefore these payers are likely to become familiar with them.

Texas is undoubtedly leading the closed formulary movement in workers' compensation. Their process is defined by a series of regulations in the Texas Administrative Code. According to their website, "These rules cover commonly used definitions, initial pharmaceutical coverage, prescribing of generics and over-the-counter drugs in addition to brand name drugs, a pharmacy fee guideline, open and closed formularies . . .." There is an effort to control cost that is apparent in the focus on generic and over the counter medications.

Beyond the cost control element, there is a care control element also apparent in the process. A month or so ago, the workers' compensation world was abuzz with discussion of the U.S. Food and Drug Administration's (FDA) approval of a new opium-based medication, Zohydro. This is five to ten times more powerful than previous iterations of hydrocodone. The FDA approval has been the subject of much discussion and some criticism. Many workers' compensation markets are patiently waiting to see what effect this powerful new dosage will have on workers' compensation.

Texas is not waiting. Texas acted last week regarding Zohydro, adding Zohydro to its "N" list of medications. The medication is "not recommended for  work-related injuries." Thus any prescription for Zohydro in Texas will require preauthorization. This preemptive move will likely limit the impact of this new and very powerful medication in Texas.

Other states, without such regulatory controls in place, may soon see demand for this powerful new medication. Use, misuse or abuse in states across the country in coming months or years may demonstrate trends or illustrate the benefits of a closed formulary. Texas has acted regarding this medication within weeks of FDA approval. Other states, without such regulations may envy Texas' regulatory agility in years to come.

David Langham is deputy chief judge of the Florida Office of Judges of Workers' Compensation Claims. This column was reprinted with his permission from his Florida Workers' Comp Adjudication blog.