By: Holly Santapaga

Federal health care programs make up almost half the amount spent on healthcare nationally.[1]  The amount of money at stake in the business of federal healthcare programs makes it a hotbed for fraud and false claims. There are a multitude of different federal programs, with Medicare and Medicaid having the highest enrollment and cost annually.[2]  In 2017, the United States spent a total of $3.5 trillion on health care, with $1.5 trillion of that paid by the United States Government.[3]  The same year, Medicare had 58 million enrollees at a cost of $702 billion, while Medicaid and the Children’s Health Insurance Program had a combined enrollment of over 100 million costing $391 billion.[4]  By 2028, these programs are expected to cost around $2 trillion combined.[5]  Health care providers bill federal health care programs when they provide covered medical services.[6]

Federal health care programs include coverage for certain prescription medications when used for purposes approved by the Food and Drug Administration (“FDA”).[7]  The practice of prescribing medications for purposes other than those approved by the FDA is referred to as “off-label” usage.[8]  A lawsuit filed against the pharmaceutical giant AstraZeneca regarding off-label usage was upheld by a Delaware federal judge.[9]  The lawsuit specifically accused AstraZeneca of violating the False Claims Act by marketing the high cholesterol drug Crestor for off-label usage, which allegedly invalidated claims for reimbursement filed by prescribing physicians.[10]  An amended complaint was filed in February 2019 by petitioners in, whistleblowers who previously worked for AstraZeneca filing under the False Claims Act, allege that the company “deployed a fraudulent marketing scheme” for Crestor’s off-label uses when it was experiencing financial distress.[11]             

Petitioners further allege that AstraZeneca’s marketing campaign lead to the submission of “hundreds of thousands of false claims for reimbursement of Crestor.”[12]  AstraZeneca is also accused of providing “illegal kickbacks to healthcare professionals,” which lead them to prescribe Crestor instead of cheaper generic equivalents.[13]  The complaint highlights the harmful effects that this fraudulent marketing had on patients.[14]  Examples of AstraZeneca’s fraudulent marketing include promoting Crestor, a cholesterol medication, as incorrectly being capable of improving renal function and preventing the onset of diabetes.[15] 

Though off-label usage can lead to filing fraudulent claims under federal healthcare programs and cause serious harmful effects on patients, off-label usage is often a patient’s only hope for a cure.  According to the National Institute of Health’s National Cancer Institute, off-label usage is common in drug combinations for cancer treatments, even though the combinations are not specifically approved by the FDA.[16]  Federal health care programs cover drugs prescribed for off-label usage when they are verified in an “approved compendium,” which is a list of drug usages compiled and approved by experts.[17]  In addition to cancer patients, off-label usage can be helpful to those suffering from other rare diseases, for which there are fewer treatment options.[18]  A bill called “The Open Act” was proposed in 2017, and rewarded pharmaceutical companies that produce drugs that are effective in the treatment of rare diseases in addition to common diseases.[19]

There is a potential for off-label drug usage to cause both harm and good. Incentivizing pharmaceutical companies to cultivate off-label usage can lead to financial harm to taxpayers and physical harm to patients, as exemplified by the FCA lawsuit against AstraZeneca.[20]  Off-label usage can also be the lifesaving cure to an individual with cancer or a rare and life-threatening disease.[21]  Therefore, a balance must be struck, and the healthcare community, along with federal health care programs, must be diligent in regulating off-label usage in a way that promotes good for all. 

[1] See Everette James & Meredith Hughes, Government-Sponsored Programs Make Up 52% Of What We Spend on Healthcare, Forbes (Jul. 29, 2015), (discussing the trend of increased spending on public healthcare in the United States).

[2] Id.

[3] American Health Care: Health Spending and the Federal Budget, Committee for a Responsible Federal Budget (May 16, 2018),

[4] Id.

[5] Id.

[6] Louise Norris, How Does a Doctor’s Participation in Medicare Affect Reimbursement?, (Oct. 15, 2018),

[7] See National Cancer Institute, Off-Label Drug Use in Cancer Treatment, NIH (Jan. 1, 2014), (specifying that the purpose of FDA regulation is to ensure patient safety).

[8] Id.

[9] Adam Lidgett, AstraZeneca Stuck With FCA Case Over Crestor Marketing, Law360 (Feb. 21, 2020, 7:54 PM EST),

[10] Id.

[11] Id.; Amended Compl.¶ 1-2, Foote v. AstraZeneca L.P. No. 1:10-cv-00095 (D. Del. Feb. 5, 2019).

[12] Amended Compl., supra note 11 at ¶ 1.

[13] Id. at ¶ 13.

[14] Id. at ¶¶ 11-13.

[15] Id. at ¶¶ 11-12, 123.

[16] National Cancer Institute, supra note 7.  

[17] Id.

[18] Shannon Firth, Should FDA Treat Rare Disease Drugs Differently?, MEDPAGE TODAY (Oct. 4, 2018),

[19] Id.; H.R. 1223 – OPEN Act, (last visited Feb. 4, 2020, 11:23 PM EST),

[20] Amended Compl., supra note 11 at  ¶¶ 11-13.

[21] National Cancer Institute, supra note 7; Firth, supra note 18.

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