"Off Label" Uses of Medical Products and Services, by Vernon Sumwalt, Esq. Under most workers' compensation programs, coverage for medical treatment differs from the coverage afforded by other plans. For example, state workers' compensation programs often cover "reasonable and necessary" medical expenses related to an injury, while group health policies limit the quantity of appointments, the network of available providers, or even the total amount payable. Most workers' compensation programs do not contain the same exclusions from coverage as those in contractual or governmental plans of coverage.

These other plans often exclude coverage for "experimental" treatment. The defense that proposed treatment is "experimental" and not covered through workers' compensation has increased in popularity in all jurisdictions over the past decade. The trend corresponds to, among other things, the new clinical treatments for pain and new surgical procedures that the United States Food and Drug Administration (FDA) has yet to approve, even though the medical community accepts their use. Read more.

Off-Label Drugs and Workers' Compensation Medicare Set-Asides, by Jennifer C. Jordan, Esq. With the addition of Part D to the Medicare program in 2006, Medicare set-aside allocations ("MSAs") grew exponentially overnight. The problem was further exacerbated by the April 9, 2009 CMS memo mandating that the preferred method of drug pricing was the use of average wholesale price and that there would be no discounting for things such as patent expirations or off-label indications. Despite guidance published on June 1, 2009 stating that consideration would be given to issues potentially influencing the future drug use or cost thereof, CMS proceeded to require funding of the last known drug regimen at AWP pretty much without a second thought. Read more. 

Here's a list of some interesting cases we found on off label use of prescription drugs in workers' compensation cases. Note: Lexis.com subscribers can link to the cases below. Be sure you're logged onto your lexis.com account.

 

California: Reeds Market v. Workers' Compensation Appeals Board, 2003 Cal. Wrk. Comp. LEXIS 207. The claimant's treating physician prescribed Actiq for the off-label purpose of alleviating the complex regional pain syndrome associated with a compensable knee injury. The Workers' Compensation Appeals Board (Board) determined that the cost of that drug was compensable despite the Physicians' Desk Reference stating that that drug could be prescribed only for cancer patients. The Board concluded that the treating physician demonstrated that off-label use of drugs is common and that prescribing Actiq was appropriate. The Board observed further that the claimant's employer did not present medical evidence that prescribing the claimant Actiq was inappropriate. Read more

 

Larson's Spotlight reports noteworthy workers' comp cases each week. This list was compiled by Thomas A. Robinson, a staff writer for Larson's Workers' Compensation Law, the nation's leading authority on workers' compensation law. 

 

 

 

 > Read the summaries & court decisions.

 

1. OR: Home-Based Worker Who Tripped Over Her Dog Sustained Injury Arising Out of Employment

 

2. AR: Worker's Injuries While Walking to Smoking Area Were Not Compensable

 

3. NY: No Death Benefits For Husband's Fatal Heart Attack in Spite of Presumption of Compensability

 

4. OH: No Loss of Use of Foot Where Worker Was Able to Bear Weight on Foot and Walk With Difficulty

 

5. TX: Truck Driver Is Not a "Domestic Employee"  

Connecticut

Vannoy-Joseph v. State of Connecticut Department of Mental Health and Addiction Services, 2008 Conn. Wrk. Comp. LEXIS 7. The recommended three-level disc replacement surgery related to compensable degenerative disc disease was off-label because the U.S. Food and Drug Administration (FDA) had not approved the ProDisc device for that procedure. The Compensation Review Board (Board) was unconcerned that the use was off label but determined that the claimant not showing adequately that the proposed procedure was scientifically valid under the current circumstances required additional proceedings. The Board referred to a court opinion that stated that "a physician may prescribe a legal [device] to serve any purpose that he or she deems appropriate, regardless of whether the [device] has been approved for that use by the FDA." The Board bolstered that theory by referring to the portion of 21 U.S.C.S. § 396 that states that the Food, Drug and Cosmetic Act does not "limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship."

Idaho
 Magee v. Thompson Creek Mining Company, 133 P.3d 1226. A physician prescribed off-label use of Colchicine for the claimant's compensable acute low back pain, stretched sciatic nerve, and SI joint disruption. That physician described Colchicine as an "old anti-inflammatory" that reduces nerve and tissue swelling, but U.S. Food and Drug Administration approval of that drug was limited to treating acute gout. The state supreme court determined that the Colchicine use was no longer compensable because that form of continued treatment was not medically necessary. The state supreme court commented that the claimant did not meet his burden of proof, which including showing that receiving Colchicine resulted in gradually improving his condition.

Nebraska

Brainard v. Lawrence Paper Company, 2009 NE Wrk. Comp. LEXIS 17. The claimant's employer challenged the compensability of off-label use of anti-seizure drugs to alleviate post-traumatic headaches associated with a work-related head trauma. The workers' compensation court determined that the off-label use was valid, noting that the claimant's treating physician showed credibly that the anti-seizure drugs affect brain receptors that are a factor in the claimant's headaches. The court noted as well that the physician showed additionally that that off-label use was effective and common and that the U.S. Food and Drug Administration had only approved the drug Propanolol to treat headaches.

New York

Hillside House of Coeymans and Travelers Casualty & Surety Co., 2006 NYWCLR (LRP) LEXIS 181. The claimant's using Actiq for pain associated with compensable injuries to both knees was off label because approved use of that drug was limited to cancer patients. The Workers' Compensation Board Panel decided that that use of Actiq was non-compensable because the claimant's employer presented credible evidence that the claimant was taking an oral opiate medication and that Actiq could become addictive and/or interfere with other pain medication that the claimant was taking.

Ohio

Sugardale Foods, Inc. v. Industrial Commission of Ohio, 738 N.E.2d 1238. The claimant's self-insured employer asserted that it lacked workers' comp liability for the claimant's 1994 Steffee plating surgery. The controversy stemmed from the general policy of the Bureau of Workers' Compensation (BWC) in Ohio that that procedure, which lacked U.S. Food and Drug Administration approval in 1994, was generally considered too experimental to be approved for claimants that the State Fund covered; the employer argued that the clause in Ohio Rev. Code § 4121.31 that required that the Industrial Commission of Ohio (Commission) uniformly process medical claims against the State Fund and self-insured employers provided that self-insured employers should not be required to pay for medical procedures that the BWC would not approve for claimants who the State Fund covered. The state supreme court determined that the surgery was compensable, quoting the Commission's finding that "all medical evidence on file supports" the claim for the surgery. The state supreme court stated additionally that the BWC based its general policy of not approving payment for procedures that lacked FDA approval or were considered experimental on Ohio Rev. Code § 4123.32(D), which the state supreme court described as providing a guideline rather than a binding requirement. The state supreme court added that that "policy could reasonably be disregarded when medical evidence removes the usual justification for rejecting these claims."

Bax Global, Inc. v. The Industrial Commission of Ohio, 2007 Ohio 695. The artificial disc that a surgeon implanted in the claimant was an off-label use of that disc because the U.S. Food and Drug Administration (FDA) had not approved using that disc at the specific level of the claimant's spine where she was experiencing disc degeneration. The court of appeals concluded that the disc-replacement surgery was compensable despite being off label because it was appropriate treatment considering the ineffectiveness of non-surgical options, the operation that was performed on the claimant had been conducted successfully in Europe for years, and the FDA does not limit using medical devices to officially approved purposes.

Wyoming

Tarraferro v. State of Wyoming, 123 P.3d 912. The claimant taking Marinol to alleviate pain associated with a compensable pelvic crush injury was off-label because Marinol's approved use was limited to cancer and AIDS patients. The state supreme court determined that the Marinol prescriptions were compensable despite the off-label use because the claimant showed that taking that drug was a reasonable and necessary non-experimental approach that pain management specialists used to alleviate severe and persistent pain. The state supreme court commented further that the U.S. Food and Drug Administration (FDA) has determined that the Federal Food, Drug and Cosmetic Act limiting labeling and marketing medications "for only those uses for which the drug's safety and effectiveness have been established" does not prevent prescribing an FDA-approved drug "for uses or in treatment regimens or patient populations that are not included in approved labeling."