Purdue Pharma, L.P. v. Oregon Department of Human Services Ex Rel. Office of Medical Assistance Programs

110 P.3d 657, 199 Or. App. 199, 2005 Ore. App. LEXIS 488
CourtCourt of Appeals of Oregon
DecidedApril 20, 2005
DocketA119392
StatusPublished
Cited by5 cases

This text of 110 P.3d 657 (Purdue Pharma, L.P. v. Oregon Department of Human Services Ex Rel. Office of Medical Assistance Programs) is published on Counsel Stack Legal Research, covering Court of Appeals of Oregon primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Purdue Pharma, L.P. v. Oregon Department of Human Services Ex Rel. Office of Medical Assistance Programs, 110 P.3d 657, 199 Or. App. 199, 2005 Ore. App. LEXIS 488 (Or. Ct. App. 2005).

Opinion

*201 LANDAU, P. J.

Petitioners Purdue Pharma, L.P., and the Purdue Frederick Company seek judicial review pursuant to ORS 183.400 of an amended Department of Human Services (DHS) administrative rule that lists drugs that are approved for reimbursement by the state for clients of the Oregon Health Plan. Petitioners contend that the amended rule was adopted without compliance with applicable rulemaking procedures and exceeded the statutory authority of DHS. We conclude that DHS complied with applicable procedures and did not exceed its authority in adopting the amended rule and therefore uphold its validity.

I. BACKGROUND

A. The regulatory context

Because this case concerns a regulatory process that is relatively complex and involves more than the usual dose of acronyms and initialisms, we begin with a description of the relevant statutes and administrative rules. In 2001, the legislature enacted legislation adding a “Practitioner-Managed Prescription Drug Plan” (PMPDP) to the Oregon Health Plan. Or Laws 2001, ch 897, §§ 1-3. That legislation begins with a set of findings concerning prescription drugs:

“(1) The cost of prescription drugs in the Oregon Health Plan is growing and will soon be unsustainable;
“(2) The benefit of prescription drugs when appropriately used decreases the need for other expensive treatments and improves the health of Oregonians; and
“(3) Providing the most effective drugs in the most cost-effective manner will benefit both patients and taxpayers.”

ORS 414.330.

The legislation then declares that it is the policy of the State of Oregon that a PMPDP will ensure that

“(1) Oregonians have access to the most effective prescription drugs appropriate for their clinical conditions;
*202 “(2) Decisions concerning the clinical effectiveness of prescription drugs are made by licensed health practitioners, are informed by the latest peer-reviewed research and consider the health condition of a patient or characteristics of a patient, including the patient’s gender, race or ethnicity; and
“(3) The cost of prescription drugs in the Oregon Health Plan is managed through market competition among pharmaceutical manufacturers by publicly considering, first, the effectiveness of a given drug and, second, its relative cost.”

ORS 414.332.

To implement that policy, the legislation directs DHS to adopt a PMPDP for the Oregon Health Plan “to ensure that enrollees of the Oregon Health Plan receive the most effective prescription drug available at the best possible price.” ORS 414.334(1). The legislation requires DHS to conduct public meetings and to consult with the Health Resources Commission (HRC) and with representatives of regulatory boards and associations that represent practitioners who would prescribe the drugs. ORS 414.334(2), (3).

In response to the legislation, DHS adopted an administrative rule establishing procedures for determining which prescription drugs to include on the PMPDP “Plan Drug List” (PDL). OAR 410-121-0030(2) (2003). According to that rule, the PDL consists of “prescription drugs for selected classes that DHS, in consultation with the Health Resources Commission (HRC), has determined represent[] effective drug(s) available at the best possible price[.]” OAR 410-121-0030(2)(b) (2003). For each selected drug class, the PDL is supposed to “identify a drug(s) as the benchmark drug that has been determined to be the most effective drug(s) available for the best possible price[.]” OAR 410-121-0030(2)(c) (2003).

The rule describes the process by which DHS selects prescription drugs for inclusion on the PDL:

“(a) DHS will utilize the recommendations made by the HRC, which result from an evidence-based evaluation process, as the basis for identifying the most effective drug(s) within a selected drug class;
*203 “(b) DHS will determine the drug(s) identified in (3)(a) that is available for the best possible price; and considering any input from the HRC, other FDA approved drug(s) in the same class that are available for a lesser relative price.”

OAR 410-121-0030(3) (2003).

Included in the process is a method of calculating the relative costs of drugs:

“(a) DHS will determine the relative cost of all drugs in each selected class that are Medicaid reimbursable and that the FDA has determined to be safe and effective;
“(b) DHS will first determine the benchmark drug based on the Average Wholesale Price (AWP) on the first of the month in which DHS reviews that specific drug class;
“(c) Once the cost of the benchmark drug is determined, the costs of other FDA approved drugs in the class will be recalculated using AWP, Oregon Maximum Allowable Cost (OMAC) and/or Federal Upper Limits in effect on the first of the month in which DHS reviews that specific drug class * * * less average rebate. Drugs with prices under 105% of the benchmark drug price will be included on the [PDL];
“(d) DHS will consider price, rebate, and the stability of both over a period of time in determining the cost effectiveness. DHS may also consider dosing issues, patterns of use and compliance issues. These factors will be weighed with any advice provided by the Health Resources Commission in reaching a final decision.”

OAR 410-121-0030(4) (2003).

The list itself is published as a table appended to the administrative rule. Table 121-0030-1.

B. Adoption of the challenged amended rule

In September 2001, HRC began the drug evaluation process. Early the following year, HRC appointed a subcommittee consisting of physicians, pharmacists, and other health care professionals to perform a review of a particular class of drugs — long-acting opioid analgesics used for non-cancer pain. After several months of study, the subcommittee concluded:

*204 “[T]here is insufficient evidence to draw any conclusions about the comparative effectiveness of long-acting opioid [analgesics]. There is also insufficient evidence to draw conclusions about incidence and nature of adverse effects, including discontinuation rates and addiction and abuse of long-acting opioid [analgesics].

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Cite This Page — Counsel Stack

Bluebook (online)
110 P.3d 657, 199 Or. App. 199, 2005 Ore. App. LEXIS 488, Counsel Stack Legal Research, https://law.counselstack.com/opinion/purdue-pharma-lp-v-oregon-department-of-human-services-ex-rel-office-orctapp-2005.