By: Holly Santapaga
Federal health care programs make up almost half the amount spent on healthcare nationally. 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. 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. 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. By 2028, these programs are expected to cost around $2 trillion combined. Health care providers bill federal health care programs when they provide covered medical services.
Federal health care programs include coverage for certain prescription medications when used for purposes approved by the Food and Drug Administration (“FDA”). The practice of prescribing medications for purposes other than those approved by the FDA is referred to as “off-label” usage. A lawsuit filed against the pharmaceutical giant AstraZeneca regarding off-label usage was upheld by a Delaware federal judge. 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. 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.
Petitioners further allege that AstraZeneca’s marketing campaign lead to the submission of “hundreds of thousands of false claims for reimbursement of Crestor.” AstraZeneca is also accused of providing “illegal kickbacks to healthcare professionals,” which lead them to prescribe Crestor instead of cheaper generic equivalents. The complaint highlights the harmful effects that this fraudulent marketing had on patients. 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.
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. 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. 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. 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.
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. Off-label usage can also be the lifesaving cure to an individual with cancer or a rare and life-threatening disease. 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.
 See Everette James & Meredith Hughes, Government-Sponsored Programs Make Up 52% Of What We Spend on Healthcare, Forbes (Jul. 29, 2015), https://www.forbes.com/sites/realspin/2015/07/29/for-the-first-time-government-programs-make-up-the-majority-of-u-s-health-spending/#7ecfdc04137f (discussing the trend of increased spending on public healthcare in the United States).
 American Health Care: Health Spending and the Federal Budget, Committee for a Responsible Federal Budget (May 16, 2018), https://www.crfb.org/papers/american-health-care-health-spending-and-federal-budget.
 Louise Norris, How Does a Doctor’s Participation in Medicare Affect Reimbursement?, MedicareResources.org (Oct. 15, 2018), https://www.medicareresources.org/faqs/how-does-medicare-reimbursement-work/.
 See National Cancer Institute, Off-Label Drug Use in Cancer Treatment, NIH (Jan. 1, 2014), https://www.cancer.gov/about-cancer/treatment/drugs/off-label (specifying that the purpose of FDA regulation is to ensure patient safety).
 Adam Lidgett, AstraZeneca Stuck With FCA Case Over Crestor Marketing, Law360 (Feb. 21, 2020, 7:54 PM EST), https://www.law360.com/governmentcontracts/articles/1246403/-astrazeneca-stuck-with-fca-case-over-crestor-marketing.
 Id.; Amended Compl.¶ 1-2, Foote v. AstraZeneca L.P. No. 1:10-cv-00095 (D. Del. Feb. 5, 2019).
 Amended Compl., supra note 11 at ¶ 1.
 Id. at ¶ 13.
 Id. at ¶¶ 11-13.
 Id. at ¶¶ 11-12, 123.
 National Cancer Institute, supra note 7.
 Shannon Firth, Should FDA Treat Rare Disease Drugs Differently?, MEDPAGE TODAY (Oct. 4, 2018), https://www.medpagetoday.com/publichealthpolicy/fdageneral/75512.
 Id.; H.R. 1223 – OPEN Act, (last visited Feb. 4, 2020, 11:23 PM EST), https://www.congress.gov/bill/115th-congress/house-bill/1223.
 Amended Compl., supra note 11 at ¶¶ 11-13.
 National Cancer Institute, supra note 7; Firth, supra note 18.