Pharmacy Buying Assoc., Inc. v. Sebelius

• Decision Date: 29 October 2012
• Docket Number: Cases No. A–12–CA–156–SS.
• Citation: 906 F.Supp.2d 604
• Parties: PHARMACY BUYING ASSOC., INC. d/b/a PBA Health and Texas TrueCare, et al., Plaintiffs v. Kathleen SEBELIUS, Secretary, United States Department Of Health and Human Services and Kyle L. Janek, M.D., Executive Commissioner, Texas Health and Human Services Commission, Defendants.
• Court: U.S. District Court — Western District of Texas

906 F.Supp.2d 604

PHARMACY BUYING ASSOC., INC. d/b/a PBA Health and Texas TrueCare, et al., Plaintiffs

v.Kathleen SEBELIUS, Secretary, United States Department Of Health and Human Services and Kyle L. Janek, M.D., Executive Commissioner, Texas Health and Human Services Commission, Defendants.

Cases No. A–12–CA–156–SS.

United States District Court,

W.D. Texas,

Austin Division.

Oct. 29, 2012.

Jennifer Scott Riggs, Riggs Aleshire & Ray, PC, Austin, TX, for Plaintiffs.

Scott Risner, U.S. Department of Justice, Washington, DC, for Defendants.

Amber S. Miller, ZS Brady & Co., Lubbock, TX, David A. Balto, Law Offices of David Balto, Washington, DC, for Texas Association of Mexican American Chamber of Commerce.

ORDER

SAM SPARKS, District Judge.

BE IT REMEMBERED on this day the Court reviewed the file in the above-styled cause, and specifically Defendant Kyle L. Janek's ¹ Motion to Dismiss Plaintiffs' First Amended Original Complaint [# 29],² Plaintiffs' Corrected Response [# 40], and Janek's Reply [# 45]. Having reviewed the documents, the relevant law, and the file as a whole, the Court now enters the following opinion and orders GRANTING the motion to dismiss. ³

Background

Plaintiffs Pharmacy Buying Association, Inc. d/b/a Texas TrueCare and PBA Health (TrueCare), Santos O. Gonzalez, DeLeon's Pharmacy, Inc., Clinic Pharmacy, LLC (Clinic), Robert L. Tyson, Jane Does 1–4 and John Does 1–4 bring this action against Kathleen Sebelius, Secretary of the United States Department of Health and Human Services (HHS) and Kyle L. Janek, M.D., Executive Commissioner of the Texas Health and Human Services Commission (HHSC). TrueCare is a membership-based organization of independent pharmacies located in part in Texas. Gonzalez and Tyson are pharmacists operating independent pharmacies in Texas. DeLeon's and Clinic are independent pharmacies operating in Texas. Jane and John Does are Medicaid recipients, or next friends to minor children recipients. Am. Compl. ¶¶ 1–10.

The Supreme Court recently summarized the basic structure of the Medicaid program:

Medicaid is a cooperative federal-state program that provides medical care to needy individuals. To qualify for federal funds, States must submit to a federal agency ( [the Centers for Medicare & Medicaid Services, or CMS], a division of the Department of Health and Human Services) a state Medicaid plan that details the nature and scope of the State's Medicaid program. It must also submit any amendments to the plan that it may make from time to time. And it must receive the agency's approval of the plan and any amendments. Before granting approval, the agency reviews the State's plan and amendments to determine whether they comply with the statutory and regulatory requirements governing the Medicaid program. And the agency's director has specified that the agency will not provide federal funds for any state plan amendment until the agency approves the amendment.

Douglas v. Indep. Living Ctr. of S. Cal., Inc., ––– U.S. ––––, 132 S.Ct. 1204, 1208, 182 L.Ed.2d 101 (2012) (internal citations omitted). As in Douglas, the relevant statutory provision here provides a State's Medicaid plan and amendments must:

provide such methods and procedures relating to the utilization of, and the payment for, care and services available under the plan ... as may be necessary to safeguard against unnecessary utilization of such care and services and to assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.

42 U.S.C. § 1396a(a)(30)(A) (Section 30(A)).

Specifically at issue in this action are the Medicaid plan and amendments in place in Texas. According to Plaintiffs, prior to March 1, 2012, Texas's Medicaid outpatient drug benefit was primarily provided through HHSC's Vendor Drug Program and in accordance with the reimbursement methodology set forth in the Texas Administrative Code and approved by CMS. However, in 2011 the Texas Legislature directed adoption of a managed care model in legislation referred to as “Senate Bill 7.” Tex. S.B. 7, 82d Leg., 1st C.S. (2011). As of March 1, 2012, HHSC instituted new regulations, referred to here as the Demonstration Project, requiring virtually all Medicaid recipients in Texas to enroll in the STAR or STAR+PLUS Medicaid managed care programs and to obtain their prescriptions from pharmacies within those programs. Am. Compl. ¶ 39.

Unlike in a traditional fee-for-service model, under a managed care program, the managed care organizations (MCOs) enter into comprehensive risk contracts with a state. See42 U.S.C. § 1396b(m) (defining MCOs); 42 C.F.R. § 438.1(a) (rules regarding MCOs and contracts with a state). Under a risk contract, the MCO is paid a “capitation payment,” ⁴ and in return assumes risk for the costs of the services covered under the contract and incurs loss when the cost of furnishing the services exceeds the payments under the contract. 42 C.F.R. § 438.2 (defining risk contract). The “capitation payment” is required by law to be “actuarially sound.” 42 U.S.C. § 1396b(m)(2)(A)(xiii)(II) (capitation rates paid to MCO subject to regulations requiring actuarially sound rates); 42 C.F.R. § 438.6(c)(2)(i) (“All payments under risk contracts and all risk-sharing mechanisms in contracts must be actuarially sound.”). However, both CMS and HHSC have disavowed any obligation to regulate payment rates between MCOs or their subcontracted Pharmacy Benefit Managers (PBMs) and network providers. See67 Fed.Reg. 40998, 41019 (June 14, 2002) (“Except in the case of payments to [Federal Qualified Health Centers] ... we do not regulate the payment rates between MCOs and subcontracting providers” and, as to subcontracts between MCOs and their subcontracting providers, “CMS does not review these subcontracts.”); 36 Tex. Reg. 8667 (Dec. 23, 2011) (federal regulations “have been interpreted to generally prohibit the state from mandating payment of specific provider rates by managed care organizations”).

Both Plaintiffs and Janek agree Texas submitted to CMS, and obtained approval for, the Demonstration Project managed care model as a “section 1115 Demonstration.” Compl. [# 1], Ex. 1, at 1; ⁵see also42 U.S.C. § 1315(a)(1) (authorizing waiver of state plan requirements for experimental, pilot or demonstration projects). Specifically, Janek obtained four waivers from CMS, “to conduct a phased transition of Medicaid beneficiaries from fee-for-service to managed care delivery system.” Compl. [# 1] Ex. 1, at 5. The waivers clearly state, however, “[a]ll requirements of the Medicaid program expressed in law, regulation, and policy statements, not expressly waived in this list, shall apply to the Demonstration project.” Id. Although 42 U.S.C. §§ 1396a(a)(1), 1396a(a)(10)(B), 1396a(a)(23)(A) and 1396a(a)(5) were waived, provisions requiring medical assistance be made available, furnished with reasonable promptness, and obtained from any qualified community pharmacy, as well as Section 30(A), were not waived. Compl. [# 1], Ex. 1, at 5–6; see also42 U.S.C. § 1396a(a)(8) (medical “assistance shall be furnished with reasonable promptness to all eligible individuals”); 1396a(a)(10)(A)-(C) (“making medical assistance available”); 1396a(a)(23)(A) (“any individual eligible for medical assistance (including drugs) may obtain such assistance from any institution, agency, community pharmacy, or person, qualified to perform the service or services required”). ⁶Section 1396a(a)(4)(D)—requiring each entity “responsible for selecting, awarding, or otherwise obtaining items and services under the State plan” be subject to safeguards against conflicts of interest—was also not waived.

Approval of the Demonstration Project was also subject to certain Special Terms and Conditions (STCs). In pertinent part, the STCs require:

22. Readiness Review Requirements for STAR and STAR+PLUS Expansions.

The state will submit to CMS, documentation regarding network adequacy and capacity for the STAR and STAR+PLUS Expansions, as described below:

a. the Readiness Review for the STAR and STAR+PLUS Expansions will consist of the following elements:

i. Review and approval of managed care contract amendments; and

ii. Review of the State plans for monitoring, overseeing, and ensuring compliance with MCO contract requirements, including network adequacy.

b. Prior to the State's planned implementation date for STAR and STAR+PLUS expansions, the state must submit the following to CMS review, according to the timelines specified below: ...

v. Demonstration of network adequacy according to the list of deliverables provided in paragraph 24(e) (December 23, 2011); and

vi. Proposed managed care contracts or contract amendments, as needed, to implement the STAR and STAR+PLUS Expansions (December 23, 2011)

....

d. The State must postpone the March 2012 implementation of STAR and STAR+PLUS Expansions (in whole or in part) if requested to do so by CMS....

24. Network Requirements. The State must, through contract with MCOs, ensure the delivery of all covered benefits, including high quality care. Services must be delivered in a culturally competent manner, and the MCO network must be sufficient to provide access to covered services to the low-income population.

Compl. [# 1], Ex. 1, at 12–14. The STCs further require Texas to “provide adequate assurances that it has sufficient capacity to serve the expected enrollment in its service area,” specifically in the form of “supporting documentation that must show that the MCO offers an adequate range of preventive, primary, pharmacy, and specialty service care for the anticipated number of enrollees in the service area.” Id. at 15.

Plaintiffs allege Defendants have not met the requirements of both the Medicaid program and the STCs as they...