Pharmaceutical Care Management v. Leslie Rutledge
Opinion
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In this dispute between a pharmacy trade association, Pharmaceutical Care Management Association (PCMA) and the State of Arkansas, PCMA appeals the district court's ruling that an Arkansas state statute is not preempted by Medicare Part D, 42 U.S.C. § 1395w-26(b)(3), and the State of Arkansas appeals the district court's ruling that the statute
is
preempted by ERISA,
I. BACKGROUND
In 2015, the Arkansas General Assembly passed a state law which attempted to govern the conduct of pharmacy benefits managers ("PBMs")-the entities that verify benefits and manage financial transactions among pharmacies, healthcare payors, and patients. PBMs are intermediaries between health plans and pharmacies, and provide services such as claims processing, managing data, mail-order drug sales, calculating benefit levels and making disbursements. Pharmacies acquire their drug inventories from wholesalers. The patient buys the drug from the pharmacy, but often at a lower price due to participation in a health plan that covers part of the price. Further, the PBMs create a maximum allowable cost ("MAC") list which sets reimbursement rates to pharmacies dispensing generic drugs. Contracts between PBMs and pharmacies create pharmacy networks. Based upon these contracts and in order to participate in a preferred network, some pharmacies choose to accept lower reimbursements for dispensed prescriptions. Thus, unfortunately, a pharmacy might actually lose money on a given prescription transaction.
In an attempt to address the trend in Arkansas of significantly fewer independent and rural-serving pharmacies in the state, the state legislature adopted Act 900, Arkansas Code Annotated § 17-92-507, an amendment to the state's then-existing MAC law, to "Amend the Laws Regarding Maximum Allowable Cost Lists; to Create Accountability in the Establishment of Prescription Drug Pricing." 2015 Ark. Laws Act 900, S.B. 688 (Ark. 2015). The Act mandates that pharmacies be reimbursed for generic drugs at a price equal to or higher than the pharmacies' cost for the drug based on the invoice from the wholesaler. It did this by defining "pharmacy acquisition cost" as the amount charged by the wholesaler as evidenced by the invoice.
PCMA brought this action on behalf of its members, the nation's leading PBMs, claiming Act 900 is preempted by both ERISA and Medicare Part D, and also that it is unconstitutional on a number of other grounds not at issue on appeal (because PCMA did not appeal the district court's adverse ruling on these claims). The district court agreed that the pertinent
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portions of Act 900 were preempted by ERISA based upon controlling Eighth Circuit case law.
See
Pharm. Care Mgmt. Ass'n v. Gerhart
,
II. DISCUSSION
We review de novo the district court's preemption/statutory interpretation rulings.
A. ERISA Preemption
ERISA preempts "any and all State laws insofar as they may now or hereafter relate to any employee benefit plans."
The state argues that
Gerhart
should be limited to its consideration of the Iowa Act's "express reference" to ERISA, and that
Gerhart
's "implicit reference" analysis is dicta inconsistent with Supreme Court precedent. We disagree. In addition to finding that Iowa Code § 510B.8 had a prohibited express reference to ERISA, the
Gerhart
court found that the "Iowa law also makes implicit reference to ERISA through regulation of PBMs who administer benefits for 'covered entities,' which, by definition, include health benefit plans and employers, labor unions, or other groups 'that provide[ ] health coverage.' These entities are necessarily subject to ERISA regulation."
B. Medicare Part D and Preemption
Medicare Part D is a comprehensive statutory and regulatory scheme for prescription drugs, which aims to balance cost with access to those drugs. The Part D program funds prescription drug benefits through payments from the Medicare government trust fund, and beneficiaries generally get prescriptions through a Part D network provider.
See
1. Negotiated Prices Standard
42 U.S.C. § 1395w-102 sets forth several requirements for standard prescription drug coverage and access to negotiated prices. Most specifically, the regulation defines "negotiated prices" for Part D drugs as the price: "the part D sponsor (or other intermediary contracting organization) [such as a PBM] and the network dispensing pharmacy ... have negotiated as the amount such network entity will receive, in total, for a particular drug."
Act 900 acts "with respect to" the Negotiated Price Standard, first and most obviously by regulating the price of retail drugs. Act 900 effectively replaces the negotiated MAC price with the pharmacy acquisition cost when the MAC rate is below the pharmacy's invoice cost, Arkansas Code Annotated § 17-92-507(b)(4)(A)(i)(b), and requires that the price paid by pharmacy customers be no less than the price negotiated by the pharmacy with its wholesaler,
The state argues the district court correctly found that Act 900 did not act "with respect to" the Negotiated Price Standard because Part D's "negotiated prices" provisions are not a substantive standard,
1
and in any event these provisions
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exclude Act 900's contingent amounts from its meaning. Further it argues the CMS did not mean to control prices by regulating, but instead merely meant to provide transparency and to control entities such as the PBMs. The district court cursorily reasoned that Act 900 was not preempted, in part because it did not affect negotiated prices. The court found that Act 900 would only act to increase prices, leading to an appeal, and the resulting price after the appeal would fall into the category of a "contingent" amount, which Part D expressly excludes from its standard,
2. Pharmacy Access Standard
Medicare Part D also sets forth requirements with regard to Medicare recipients' access to pharmacies. 42 U.S.C. § 1395w-104(b)(1)(C) provides that a prescription drug plan "shall secure the participation in its network of a sufficient number of pharmacies that dispense (other than by mail order) drugs directly to patients to ensure convenient access (consistent with rules established by the Secretary)." The regulations in
The district court found that because the decline-to-dispense provisions do not render a pharmacy as out-of-network, Act 900 did not act "with respect to" the standard. We disagree, and find that Act 900 indeed acts "with respect to" the Pharmacy Access Standard, because a pharmacy that refuses to dispense drugs becomes, in effect, an out-of-network pharmacy. Act 900's decline-to-dispense clause could conceivably, and likely would, lead to a beneficiary being unable to fill a prescription in his or her geographical location. This would actually interfere with convenient access to prescription drug availability, which is more than is required for preemption. Again, if the state law in question merely acts "with respect to" the standard, it is preempted. It clearly does in this instance. Accordingly, we find that Act 900 is preempted by Medicare Part D.
III. CONCLUSION
We affirm the district court's ERISA ruling, reverse the Medicare Part D ruling, and remand for entry of judgment in PCMA's favor.
It is, in fact a standard, as a standard within the meaning of the preemption provision is either a statutory provision or a regulation duly promulgated and published in the Code of Federal Regulations.
Do Sung Uhm v. Humana, Inc.
,
Reference
- Full Case Name
- PHARMACEUTICAL CARE MANAGEMENT ASSOCIATION, Plaintiff-Appellant v. Leslie RUTLEDGE, in Her Official Capacity as Attorney General of Arkansas, Defendant-Appellee Arkansas Pharmacists Association ; National Community Pharmacists Association, Amici on Behalf of Appellee(s). Pharmaceutical Care Management Association, Plaintiff-Appellee v. Leslie Rutledge, in Her Official Capacity as Attorney General of Arkansas, Defendant-Appellant National Community Pharmacists Association; Arkansas Pharmacists Association, Amici on Behalf of Appellant(s).
- Cited By
- 6 cases
- Status
- Published