Intervening in four whistleblower suits brought against Walgreen Co. and its subsidiaries, the Department of Justice (DOJ) has alleged that the retail pharmacy chain dispensed millions of illicit prescriptions for opioids and other controlled substances and illegally sought reimbursement for many of the prescriptions from federal health care programs (United States v. Walgreen Co., No. 1:18-cv-05452 (N.D. Ill.)).

In a 300-page complaint in intervention filed Jan. 16 in the U.S. District Court for the Northern District of Illinois, the government alleged that the actions by Walgreens, which has more than 8,000 pharmacies in the United States, violated both the Controlled Substances Act (CSA) and the False Claims Act (FCA), and that the company helped fuel the U.S. opioid crisis by not meeting its responsibility to confirm the validity of controlled substance prescriptions.

From August 2012 to the present, Walgreens “knowingly filled millions of prescriptions for controlled substances that lacked a legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice,” the DOJ said in announcing the filing of the complaint in intervention.

The illicit prescriptions allegedly dispensed by the drug store chain included excessive quantities of opioids, early refills of opioid prescriptions, and dangerous and widely abused “cocktail” combinations of opioids, benzodiazepine and muscle relaxants.

Red Flags

The company filled “millions” of the illicit prescriptions, the DOJ said, despite “egregious” red flags indicating that they were likely to be unlawful.

Among the red flags of possible abuse and diversion cited by the government in the complaint were:

• prescriptions for high dosages and quantities of opioids;
• prescriptions for combinations of controlled substances that are unlikely to serve a legitimate medical purpose or are frequently abused;
• prescriptions written by multiple prescribers, especially when the prescriptions are for the same types or combinations of controlled substances;
• prescriptions filled by a patient at multiple pharmacies that have been issued at about the same time;
• patients seeking to fill or refill prescriptions before an earlier prescription for the same drug has run out;
• patients traveling long distances to obtain a prescription from a prescriber or to fill a prescription at a pharmacy;
• prescriptions written by prescribers who have a pattern of writing prescriptions for the same drugs, quantities and strengths for multiple patients; and
• patients paying cash for a prescription, particularly when the patient is paying out of pocket for controlled substance prescriptions but using insurance to pay for other prescriptions.

Evidence Allegedly Ignored

“Walgreens allegedly ignored substantial evidence from multiple sources that its stores were dispensing unlawful prescriptions, including from its own pharmacists and internal data,” the DOJ said.

For example, the company’s pharmacy compliance department, the Pharmaceutical Integrity Team (RxIntegrity), which was tasked with coordinating the company’s controlled substance dispensing compliance efforts, allegedly “knew that Walgreens’ nominal compliance policies were ineffective and frequently ignored by Walgreens’ overworked pharmacists.”

An analysis performed quarterly by RxIntegrity identified pharmacists who ranked in the 94th percentile or above of Walgreens pharmacists in several categories, including the dispensing of high doses of controlled substances and the dispensing of large quantities of oxycodone, hydromorphone and methadone.

The quarterly analysis “consistently showed that Walgreens’ high-fill pharmacists were filling prescriptions with egregious red flags, which RxIntegrity knew were indicative of abuse or diversion,” the government alleged in the complaint. “Nonetheless, Walgreens failed to take effective corrective action to prevent the filling of invalid prescriptions.”

Alleged Pressure on Pharmacists To Fill Prescriptions

The government also alleged that Walgreens “systematically pressured its pharmacists to fill prescriptions quickly without taking the time needed to confirm each prescription’s validity.”

According to the DOJ’s complaint, the company “was aware of its obligation to exercise corresponding responsibility” in accordance with 21 C.F.R. §1306.04.

For example, the company had entered into a June 2013 settlement and memorandum of agreement with the DOJ and DEA, through which Walgreens acknowledged that some of its pharmacies dispensed controlled substances “in a manner not fully consistent with its compliance obligations under the CSA [and] implementing regulations” and agreed to implement compliance measures.

However, “at the same time that Walgreens issued paper compliance policies that reflected its understanding of its legal obligations,” the government alleged in the complaint. “Walgreens took other corporate actions that Walgreens knew prevented its pharmacists from complying with those policies and their legal obligations.”

The DOJ said that the pharmacy chain used metrics that tracked the number of prescriptions filled and every step in the prescription filling process “and set unrealistic goals for those metrics,” which “resulted in Walgreens’ pharmacists filling invalid prescriptions.”

“Verify by Promise Time.” Under one metric, “Verify by Promise Time” (VBPT), a pharmacist was expected to fill a prescription within 15 minutes for customers waiting in the pharmacy store.

“VBPT often did not provide pharmacists nearly enough time to perform adequate due diligence before filling prescriptions for controlled substances, including Schedule II opioid prescriptions,” the department said.

The company “enforced VBPT through performance evaluations and discipline,” and the metric was “a significant factor” in a pharmacy employee’s performance evaluation, the government alleged. “If a pharmacist failed to satisfy VBPT,” it said, “the employee could receive a negative performance evaluation and be subject to discipline or termination.”

Non-dispensing Pharmacist Reports. The company also allegedly tracked pharmacists that dispensed a low rate of controlled substances through its “Non-dispensing Pharmacist Report,” which the DOJ said was created “in part because it believed pharmacists who refused to fill controlled substance prescriptions compromised Walgreens’ customer service.”

The company allegedly encouraged its managers to meet with pharmacists that dispensed low rates of controlled substances. “In these meetings,” the government said in the complaint, “the managers were instructed to question the pharmacists’ decision-making and encourage the pharmacist to become more comfortable dispensing controlled substances.”

Customer complaints. Also, the DOJ said, Walgreens “carefully tracked customer complaints, including complaints about refusals to fill, as part of a pharmacy’s customer service metrics, resulting in pressure on pharmacists to avoid complaints by filling all prescriptions.”

The company’s focus on these metrics and pharmacy profitability “caused managers to pressure pharmacists to quickly fill controlled substance prescriptions that presented egregious red flags,” the government alleged.

“Many Walgreens pharmacists reported having managers question their decisions to reject controlled substance prescriptions or having managers instruct them to fill future controlled substance prescriptions the pharmacist had rejected or believed should not be filled,” the DOJ said in the complaint. “Walgreens pharmacists reported being pressured to fill not just by managers with pharmacy training but also by non-pharmacist store managers with no such experience.”

False Claims Allegations

In its complaint, the government also alleged that beginning in August 2012 Walgreens knowingly presented false or fraudulent reimbursement claims for the illicit prescriptions to federal health care programs in violation of the FCA.

Moreover, the DOJ alleged, the company violated the FCA by submitting claims data, certifications and attestations that were false to the health care programs. The submissions were material to the payment of the false or fraudulent reimbursement claims, the government said.

According to the department, if found liable, Walgreens could face civil penalties of us to $80,850 for each unlawful prescription filled in violation of the CSA, as well as treble damages and applicable penalties for each prescription paid by federal health care programs in violation of the FCA.

Walgreens Statement

In a Jan. 17 statement, Walgreens said that it would be asking the court “to clarify the responsibilities of pharmacies and pharmacists and to protect against the government’s attempt to enforce arbitrary ‘rules’ that do not appear in any law or regulation and never went through any official rulemaking process.”

“We will not stand by and allow the government to put our pharmacists in a no-win situation, trying to comply with ‘rules’ that simply do not exist,” the company asserted.

“Walgreens stands behind our pharmacists, dedicated health care professionals who live in the communities they serve, filling legitimate prescriptions for FDA-approved medications written by DEA-licensed prescribers in accordance with all applicable laws and regulations,” the company added. “We look forward to the opportunity to defend the professionalism and integrity of our pharmacists.”