Aids Healthcare Foundation v. Douglas

27 F. Supp. 3d 1055, 2014 WL 2761552
CourtDistrict Court, C.D. California
DecidedJune 18, 2014
DocketCase No. CV 09-8199-R
StatusPublished

This text of 27 F. Supp. 3d 1055 (Aids Healthcare Foundation v. Douglas) is published on Counsel Stack Legal Research, covering District Court, C.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Aids Healthcare Foundation v. Douglas, 27 F. Supp. 3d 1055, 2014 WL 2761552 (C.D. Cal. 2014).

Opinion

AMENDED FINDINGS OF UNCON-TROVERTED FACTS AND CONCLUSIONS OF LAW IN SUPPORT OF JUDGMENT

MANUEL L. REAL, District Judge.

INTRODUCTION

Plaintiff Aids Healthcare Foundation (“Plaintiff’ or “AHF”) initiated this action against Defendant Toby Douglas, Director of the California Department of Health Care Services (“Defendant” or the “Department”), in response to Section 14105.46 of the California Welfare and Institutions Code (“Section 14105.46”), which imposed new requirements on prescription drug providers that participate in the 340B program of Section 602 of the Veterans Health Care Act of 1992, codified at Title 42 U.S.C. § 256b. The parties filed cross motions for summary judgment on the Plaintiffs remaining claims. The Court granted, in part, and denied, in part, each party’s motion. The Ninth Circuit remanded this case in light of the January 30, 2014 approval of the State Plan Amendment by the Centers for Medicare and Medicaid Services (“CMS”). Having considered the 2014 CMS approval, in support of its Judgment, the Court makes the following amended findings of fact and conclusions of law:

FINDINGS OF UNCONTROVERTED FACT

1. Plaintiff AHF is a California nonprofit corporation that voluntarily participates in Medi-Cal’s 340B program as a provider of health care services and, among other things, furnishes outpatient prescription drugs to Medi-Cal patients.

2. Plaintiff AHF obtains savings on purchases of drugs as a participant of the 340B program.

3. The Department is the single state agency that administers California’s Medicaid program, known as Medi-Cal.

4. On July 28, 2009, the Governor signed into law Assembly Bill X4-5 (the Special Session healthcare trailer bill).

5. Section 40 of Assembly Bill X4-5 added Section 14105.46 to the Welfare and Institutions Code.

[1058]*10586. Section 14105.46 requires 340B safety net providers to dispense to Medi-Cal beneficiaries only drugs purchased through the 340B Program.

7. Prior to the enactment of Section 14105.46, 340B safety net providers who also participated in Medi-Cal had the option of purchasing drugs dispensed to Medi-Cal beneficiaries through the 340B program or on the open market.

8. Before Section 14105.46, safety net ■ providers that dispensed 340B drugs for their Medicaid patients would be reimbursed under Welfare & Institutions Code § 14105.45.

9. Under Welfare & Institutions Code § 14105.45(b), pharmacy providers are reimbursed the lower of the estimated acquisition cost of the drug plus a dispensing fee or the pharmacy’s usual and customary charge as defined in Welfare and Institutions Code § 14105.455.

10. Welfare & Institutions Code states that pharmacy providers shall be . paid at the lesser of their usual and customary charges or the reimbursement rate established under Welfare & Institutions Code § 14105.45(b).

11. The amount reimbursed by MediCal to pharmacy providers under Welfare & Institutions Code § 14105.455 does not depend on the actual acquisition cost of the drugs to pharmacy services providers.

12. Section 14105.46 requires providers that participate in the 340B drug pricing program to dispense only 340B drugs to Medi-Cal beneficiaries.

13. Section 14105.46 requires providers that participate in the 340B drug pricing program to bill Medi-Cal an amount not to exceed the provider’s ' actual acquisition cost for the drug, plus a statutorily-set dispensing fee.

14. Section 14015.46 was enacted to: (1) reduce the risk of double discounts, (2) reduce drug manufacturer rebate disputes, (3) reduce Medi-Cal’s overpayments on drugs, and (4) streamline the Department’s Claims Review process.

15. The State has a legitimate interest in: (1) reducing the risk of drug manufacturers paying duplicate discounts; (2) reducing the number of drug manufacturer rebate disputes; (3) eliminating Medi-Cal’s overpayment on 340B drugs; and (4) streamlining the administration of the 340B program.

16. Due to the operation of Section 14105.46, 340B safety net providers like AHF in most cases are reimbursed less than non-340B providers for dispensing the same drugs to Medi-Cal beneficiaries.

17. 340B safety net providers are permitted to dispense drugs to MediCal beneficiaries through a contractual arrangement with another pharmacy.

18. To the extent 340B safety net providers dispense drugs to Medi-Cal beneficiaries through a contractual arrangement with a pharmacy, Section 14105.46 does not apply and the contract pharmacy is not required to dispense only drugs purchased through the 340B program to Medi-Cal beneficiary patients of the 340B safety net provider.

19. The amount of reimbursement re- . ceived by a 340B safety net provid[1059]*1059er is less than the amount that provider would receive if it contracted with a pharmacy to dispense those very same drugs to the same beneficiaries, because the contract pharmacy does not have to use 340B drugs and therefore can be reimbursed at the higher fee-for-serviee price.

20. The California Department of Health Care Services (“Department”) submitted a proposed State Plan Amendment (“SPA”) seeking approval from the Centers for Medicare and Medicaid' Services (“CMS”) to modify California’s Medicaid State Plan in conjunction with the terms of Section 14015.46.

21. The SPA the Department submitted to CMS corresponding to the relevant portions of Section 14105.46 have now been approved by CMS.

22. The portion of the State Plan that Defendant sought to amend in conjunction with Section 14105.46 is entitled “Payment Methodology for Prescription Drugs,” and the page of the SPA that incorporates Section 14015.46 is captioned “Methods and Standards for Establishing Payment Rates for Prescription Drugs.”

23. In correspondence regarding the SPA related to Section 14105.46 both the Department and CMS refer to the reimbursement change called for by the statute as- a “rate reduction.”

24. The California Legislature -enacted Section 14105.46 for the purpose of responding to the State’s fiscal problems.

25. The California Legislature did not consider whether the impact that Section 14105.46 would have on 340B safety net providers would be consistent with efficiency, economy and quality of care before enacting Section 14105.46.

26. The California Legislature did not consider whether Section' 14105.46 would have an adverse impact on whether Medi-Cal beneficiaries would have access to health care services to the same extent as the general public before enacting Section 14105.46.

27. The California Legislature did not consider the relationship between provider costs and the payments that would be made under the policy set forth in Section 14105.46 before enacting Section 14105.46.

28. The Department did not supply the California Legislature with any documents evaluating the impact of the Section 14105.46 on the Section 30(A) factors of efficiency, economy, quality and Access to Care pri- or to the enactment of Section 14105.46.

29. The Department did not consider cost studies in connection with Section 14105.46.

30.

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Bluebook (online)
27 F. Supp. 3d 1055, 2014 WL 2761552, Counsel Stack Legal Research, https://law.counselstack.com/opinion/aids-healthcare-foundation-v-douglas-cacd-2014.