United States v. Walgreen Co.

78 F.4th 87
Court of Appeals for the Fourth Circuit·Decided August 15, 2023·No. 22-1491·Published·Cited by 4 cases

Opinion

PUBLISHED

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 22-1491

UNITED STATES OF AMERICA, Plaintiff − Appellant,

and

COMMONWEALTH OF VIRGINIA, Plaintiff,

v.

WALGREEN CO., Defendant – Appellee.

------------------------------

CHAMBER OF COMMERCE OF THE UNITED STATES OF AMERICA; THE AMERICAN MEDICAL ASSOCIATION; THE MEDICAL SOCIETY OF VIRGINIA; NATIONAL ASSOCIATION OF CHAIN DRUG STORES, INCORPORATED; NATIONAL HEALTH LAW PROGRAM,

Amici Supporting Appellee.

No. 22-4292

COMMONWEALTH OF VIRGINIA, Plaintiff − Appellant,

and

UNITED STATES OF AMERICA, Plaintiff,

v.

WALGREEN CO., Defendant – Appellee.

------------------------------

CHAMBER OF COMMERCE OF THE UNITED STATES OF AMERICA; THE AMERICAN MEDICAL ASSOCIATION; THE MEDICAL SOCIETY OF VIRGINIA; NATIONAL ASSOCIATION OF CHAIN DRUG STORES, INCORPORATED; NATIONAL HEALTH LAW PROGRAM,

Amici Supporting Appellee.

Appeal from the United States District Court for the Western District of Virginia, at Abingdon. James P. Jones, Senior District Judge. (1:21−cv−00032−JPJ−PMS)

Argued: May 4, 2023 Decided: August 15, 2023

Before DIAZ, Chief Judge, and WYNN and QUATTLEBAUM, Circuit Judges.

Vacated and remanded by published opinion. Chief Judge Diaz wrote the opinion, in which Judge Wynn and Judge Quattlebaum joined.

ARGUED: Martin V. Totaro, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C.; Martin Jordan Minot, OFFICE OF THE ATTORNEY GENERAL OF VIRGINIA, Richmond, Virginia, for Appellants. Jonathan M. Phillips, GIBSON, DUNN & CRUTCHER LLP, Washington, D.C., for Appellee. ON BRIEF: Brian M. Boynton, Principal Deputy Assistant Attorney General, Michael S. Raab, Charles W. Scarborough, Civil Division, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C.; Christopher R. Kavanaugh, United States Attorney, OFFICE OF THE UNITED STATES

ATTORNEY, Roanoke, Virginia, for Appellant United States of America. Jason S. Miyares, Attorney General, Charles H. Slemp III, Chief Deputy Attorney General, W. Clay Garrett, Assistant Attorney General, Andrew N. Ferguson, Solicitor General, Erika L. Maley, Principal Deputy Solicitor General, Lucas W.E. Croslow, Deputy Solicitor General, Rohiniyurie Tashima, John Marshall Fellow, OFFICE OF THE ATTORNEY GENERAL OF VIRGINIA, Richmond, Virginia, for Appellant Commonwealth of Virginia. Reed Brodsky, New York, New York, Matt Gregory, Francesca Broggini, GIBSON, DUNN & CRUTCHER LLP, Washington, D.C., for Appellee. Tara S. Morrissey, Andrew R. Vance, UNITED STATES CHAMBER LITIGATION CENTER, Washington, D.C., for Amicus Chamber of Commerce of the United States of America. Elisabeth S. Theodore, Kolya D. Glick, ARNOLD PORTER KAYE SCHOLER LLP, Washington, D.C., for Amici Chamber of Commerce of the United States of America, The American Medical Association, and The Medical Society of Virginia. Scott McIntosh, Kirti V. Reddy, QUARLES & BRADY LLP, Washington, D.C., for Amicus National Association of Chain Drug Stores. Martha Jane Perkins, Arielle Linsey, Catherine McKee, NATIONAL HEALTH LAW PROGRAM, Chapel Hill, North Carolina, for Amicus National Health Law Program.

DIAZ, Chief Judge:

The United States and the Commonwealth of Virginia (together, the “governments”)

appeal the district court’s dismissal of their complaint under the False Claims Act, 31 U.S.C. § 3729 et seq., and Virginia state law. The governments allege that Walgreen Co. (“Walgreens”) misrepresented that certain patients met Virginia’s Medicaid-eligibility requirements for expensive Hepatitis C drugs.

The district court dismissed the complaint, holding that Virginia’s eligibility requirements violated the Medicaid Act, and therefore Walgreens’s misrepresentations were immaterial as a matter of law. We hold that the governments plausibly allege facts that establish materiality. So we vacate and remand.

I.

A.

The governments’ complaint alleges the following.

1.

Virginia participates in Medicaid and administers its state plan through its Department of Medical Assistance Services. The Department, in turn, contracts with Magellan Medicaid Administration and two managed-care organizations (Virginia Premier and Aetna) to administer patients’ Medicaid claims and cover prescription drugs.

The Department covers Sovaldi, Harvoni, and Daklinza, which are direct-acting antiviral drugs that treat Hepatitis C. 1 These drugs are “extremely expensive.” J.A. 17 ¶ 40. To control costs, the Department requires prior authorization before patients may obtain the drugs. See 42 U.S.C. § 1396r-8(d)(1)(A) (“A State may subject to prior authorization any covered outpatient drug.”).

During the relevant time, the Department had built into its prior-authorization process two eligibility requirements that are at issue here. First, a patient’s Hepatitis C had to be sufficiently severe; this generally required a fibrosis score of at least 0.59, a metavir stage of at least F3, or documented cirrhosis of the liver. 2 Second, a patient must have abstained from alcohol and illicit substances for six months, as shown by an acceptable drug- and alcohol-screening test.

The Department tasked Magellan, Virginia Premier, and Aetna with ensuring that Medicaid patients seeking coverage for direct-acting antiviral drugs met Virginia’s eligibility requirements. If they determined that the patient satisfied the criteria (including the disease-severity and substance-abstinence requirements), the patient would receive Medicaid coverage for the requested drugs and pharmacies like Walgreens would be reimbursed by Medicaid for dispensing them. Conversely, a patient deemed ineligible would be denied coverage and told why.

1

Hepatitis C is an infection caused by the hepatitis C virus that primarily affects the liver.

The fibrosis and metavir scoring systems are used to assess fibrosis, or scarring of

2

the liver, in patients with Hepatitis C.

2.

Enter Amber Reilly, a clinical pharmacy manager for a Walgreens store in Kingsport, Tennessee. Reilly told her store manager she had become “an expert in customizing [Medicaid-coverage] appeal letters” to “receiv[e] approvals [for direct-acting antiviral drugs], which in turn . . . increased profits and strengthened relationships with providers.” J.A. 20 ¶ 56.

But rather than “customizing” Medicaid paperwork, Reilly was falsifying patient records and other documents to satisfy Virginia’s eligibility requirements.

The governments’ complaint illustrates the fraudulent scheme with twelve Virginia Medicaid patients, Patients 1 through 12. For instance, Virginia Premier at first denied Patient 3’s prior-authorization request for direct-acting antiviral drugs because it wasn’t backed up by “negative urine drug screens.” J.A. 29 ¶ 107. In response, Reilly’s Walgreens store submitted reports that falsely showed Patient 3 passed the drug test. After that, the Department approved the request, costing Virginia Medicaid over $64,000.

Similarly, Patient 8 was denied prior authorization for the drugs, and on appeal to the Department, acknowledged falling short of Virginia’s metavir-score threshold. The Department upheld the denial. Then Reilly’s Walgreens store got involved, submitting a false lab report that changed Patient 8’s fibrosis score from 0.19 to 0.59 and metavir level from F0 to F3, after which the Department approved coverage and paid Walgreens over $96,000.

This fraudulent scheme took place from at least January 2015 through June 2016.

During that time, Reilly’s Walgreens store’s revenue increased more than 320% over the year before.

Walgreens learned about the fraudulent scheme at least as early as 2016, when Tennessee and Walgreens both launched investigations. Reilly has since pleaded guilty to engaging in the same scheme to defraud Tennessee’s Medicaid program. But Walgreens still hasn’t paid back any of the money it received for Virginia Medicaid Patients 1 through 12.

B.

The governments sued Walgreens, alleging (1) violations of the federal False Claims Act and Virginia’s state-law version; and (2) state-law claims of fraud, unjust enrichment, and payment by mistake.

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United States v. Walgreen Co., 78 F.4th 87 (4th Cir. 2023).

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