Cares Community Health v. United States Department of Health and Human Services

District Court, District of Columbia·Decided September 28, 2018·No. Civil Action No. 2017-2774·Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

CARES COMMUNITY HEALTH,

Plaintiff, v. Civil Action No. 17-2774 (JEB) UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al.,

Defendants.

MEMORANDUM OPINION

Plaintiff Cares Community Health provides a variety of services to people in the

Sacramento, California, area regardless of their ability to pay. Cares also operates a pharmacy

there that offers prescription drugs under Medicare Part D, and a federal program enables Cares

to procure those drugs from manufacturers at a discount. Cares, however, does not necessarily

retain the benefit of that discount; rather, at least one insurance company has altered its contract

with Cares to reimburse it at a discounted rate. As a result, Cares has now sued the U.S.

Department of Health and Human Services and certain officials, contending that the Government

has ignored a statutory duty to regulate those contracts in order to require companies to pay

Cares the market rate for discounted drugs. Defendants now move to dismiss under Federal

Rules of Civil Procedure 12(b)(1), 12(b)(6), and 12(b)(7). Finding that Cares has standing but

has failed to state a claim, the Court will grant the Motion.

1 I. Background

The Court will provide some brief background on the Medicare Part D program and

Federally Qualified Health Centers (FQHCs) — of which Cares is an example — before delving

into the facts of this particular dispute.

A. Statutory Framework

Medicare Part D subsidizes prescription drugs for Medicare beneficiaries. See 42 U.S.C.

§ 1395w-101(a)(1). To administer Part D, the Centers for Medicare and Medicaid Services

(CMS) contracts with private entities known as Part D plan “Sponsors.” Id. § 1395w-115. The

Government contracts only with those Sponsors, and not directly with pharmacies, to deliver Part

D benefits. Id. § 1395w-27(a). Sponsors then enter into contracts with pharmacies to reimburse

them for providing prescription drugs to Part D beneficiaries. Id. § 1395w-104(b).

FQHCs receive grants from the Government to provide health-care services to

communities that HHS has designated “medically underserved.” See 42 U.S.C. §§ 254b,

1396d(l)(2)(B); 42 U.S.C. § 1395x(aa)(4)(A)(i). FQHCs can bill CMS for providing Medicare

or Medicaid services. Id. §§ 1395k(a)(2)(D)(ii), 1396a(bb)(2). In addition, they may purchase

prescription drugs from manufacturers at discounted prices pursuant to the Section 340B

program. See 42 U.S.C. § 256b(a)(4)(A).

At issue in this case is a statutory provision governing payment for FQHC services. To

summarize, it provides that FQHCs must be paid “not less than” non-FQHC entities for

Medicare services. See 42 U.S.C. § 1395w-27(e)(3)(A). CMS has implemented this FQHC

payment requirement by promulgating regulations providing that “[t]he contract between the

[Sponsor] organization and CMS must specify that . . . [t]he [Sponsor] organization must pay

a[n] [FQHC] a similar amount to what it pays other providers for similar services.” 42 C.F.R. §

2 422.527(a). The dispute centers on whether this provision also applies to Part D prescription

drugs.

B. Factual History

Cares is an FQHC located in Sacramento, California, providing “services to all persons

within [its] designated medically underserved area . . . regardless of whether those persons can

pay for the services they receive.” ECF No. 13 (Am. Compl.), ¶¶ 7–8. In 2009, it entered into a

Pharmacy Provider Agreement with Part D plan Sponsor Humana Health Plan, Inc. Id., ¶ 34.

The Agreement governed Humana’s payment to Cares for any “Retail Pharmacy Services”

provided to Humana’s enrollees and covered all plans Humana offered, including Part D. Id.

When, in December 2014, Humana proposed amending the contract to reduce the Part D

payment rates for “340B pharmacy services,” Cares objected. Id., ¶¶ 37–38. The parties went to

arbitration, but the arbitrator concluded that “the ultimate ‘legal question [of whether Humana

was required to pay Cares under the pay ‘not less than’ standard] require[d] the reconciliation of

conflicting policies’ — in other words, an interpretation of federal law had to be made, which

was something the Arbitrator found was not arbitratable.” Id., ¶ 39.

Cares then filed this suit against HHS, its Secretary, and the CMS Administrator,

claiming that they had “unlawfully withheld” agency action in violation of the APA, see 5

U.S.C. § 706(1), because they failed to “carry out [their] mandatory duty to include the [FQHC

payment] requirement in contracts” with Part D plan Sponsors. See ECF No. 1 (Complaint), ¶

58. After Defendants moved to dismiss that Complaint, contending that the § 706(1) claim was

deficient because the FQHC payment requirement does not apply to Part D contracts, see ECF

No. 9 (Def. First MTD) at 16–18, Cares filed the Amended Complaint. Although the Amended

Complaint contains only one count, it appears to assert two distinct but related claims under the

3 APA — one for unlawfully withheld agency action under § 706(1) and, alternatively, one for

arbitrary and capricious agency action under § 706(2)(A). See Am. Compl., ¶¶ 44–50.

Cares seeks an order: (1) declaring that the FQHC payment requirement applies to Part D

drugs; (2) declaring “that [D]efendants have failed to exercise their nondiscretionary duty to

include the FQHC pay ‘not less than’ term in the Part D contracts it has entered into with

[Sponsors]”; (3) enjoining “[D]efendants from entering into future Part D contracts . . . that do

not include” the FQHC payment requirement; and (4) requiring, “[r]egarding existing Part D

contracts, . . . [that] [D]efendants . . . take such actions as may be necessary to ensure that the . . .

recipients of those contracts provide for payment to FQHCs with which they have contracts at a

level and amount that is not less than what they would pay other (non-FQHC) providers for

similar services.” Id. at 21. Defendants now move to dismiss the Amended Complaint pursuant

to Federal Rules of Civil Procedure 12(b)(1), 12(b)(6), and 12(b)(7). See ECF No. 14 (Def.

MTD).

II. Legal Standard

In evaluating Defendants’ Motion to Dismiss, the Court must “treat the complaint’s

factual allegations as true . . . and must grant [P]laintiff ‘the benefit of all inferences that can be

derived from the facts alleged.’” Sparrow v. United Air Lines, Inc., 216 F.3d 1111, 1113 (D.C.

Cir. 2000) (quoting Schuler v. United States, 617 F.2d 605, 608 (D.C. Cir. 1979)) (citation

omitted); see also Jerome Stevens Pharm., Inc. v. FDA, 402 F.3d 1249, 1250 (D.C. Cir.

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