United States v. Walgreen Co.

78 F.4th 87
CourtCourt of Appeals for the Fourth Circuit
DecidedAugust 15, 2023
Docket22-1491
StatusPublished
Cited by4 cases

This text of 78 F.4th 87 (United States v. Walgreen Co.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fourth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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

Opinion

USCA4 Appeal: 22-1491 Doc: 56 Filed: 08/15/2023 Pg: 1 of 19

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

Plaintiff − Appellant, USCA4 Appeal: 22-1491 Doc: 56 Filed: 08/15/2023 Pg: 2 of 19

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,

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

2 USCA4 Appeal: 22-1491 Doc: 56 Filed: 08/15/2023 Pg: 3 of 19

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.

3 USCA4 Appeal: 22-1491 Doc: 56 Filed: 08/15/2023 Pg: 4 of 19

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.

4 USCA4 Appeal: 22-1491 Doc: 56 Filed: 08/15/2023 Pg: 5 of 19

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.

5 USCA4 Appeal: 22-1491 Doc: 56 Filed: 08/15/2023 Pg: 6 of 19

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.

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78 F.4th 87, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-walgreen-co-ca4-2023.