Tap Pharmaceuticals v. U.S. Department of Health & Human Services Health Care Financing Administration Palmetto Government Benefits Administrators

163 F.3d 199, 1998 U.S. App. LEXIS 30447, 1998 WL 823504
CourtCourt of Appeals for the Fourth Circuit
DecidedNovember 30, 1998
Docket97-2773
StatusPublished
Cited by19 cases

This text of 163 F.3d 199 (Tap Pharmaceuticals v. U.S. Department of Health & Human Services Health Care Financing Administration Palmetto Government Benefits Administrators) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fourth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Tap Pharmaceuticals v. U.S. Department of Health & Human Services Health Care Financing Administration Palmetto Government Benefits Administrators, 163 F.3d 199, 1998 U.S. App. LEXIS 30447, 1998 WL 823504 (4th Cir. 1998).

Opinions

Affirmed by published opinion. Judge DIANA GRIBBON MOTZ wrote the opinion, in which Judge MURNAGHAN joined. Judge WILLIAMS wrote an opinion concurring in part and concurring in the judgment.

OPINION

DIANA GRIBBON MOTZ, Circuit Judge:

TAP Pharmaceuticals, Inc. (TAP), appeals from the dismissal of its complaint for lack of standing. TAP seeks to challenge a Medicare reimbursement policy. That policy reduces the amount of reimbursement paid for Lupron, a prostate cancer drug manufactured by TAP,to the amount paid for Zoladex, a competing prostate cancer drug made by another drug company. The district court concluded that the interests asserted by TAP in this action do not fall within the “zone of interests” protected by the Medicare [201]*201Part B program, and that therefore TAP lacked standing to sue. Although we rely on reasons somewhat different than those set forth by the district court, we reach the same conclusion. Accordingly, we affirm.

I.

Lupron and Zoladex treat prostate cancer by means of the same basic chemical mechanism, and they achieve the same level of effectiveness. The two drugs have different rates of action, however, and their particular chemical formulations implicate different adverse reactions.

Lupron is administered in liquid form by an intramuscular injection with a 22-gauge needle, while Zoladex is administered as a pellet injected under the skin with a larger, 14- or 16-gauge needle. The larger needle used in administering Zoladex may occasionally cause complications, such as keloid scarring or bleeding hematoma, which are less likely to occur with a Lupron injection. The manufacturer of Zoladex suggests that, at the option of the physician or the patient, a local anesthetic and bandage be used in administering the drug. Such procedures are unnecessary with Lupron. Some doctors prefer Lupron to Zoladex because of its less invasive means of administration.

Many patients who receive Lupron or Zo-ladex have a portion of their health care costs covered by Medicare Part B, a federal program that provides supplementary medical insurance to the elderly. 42 U.S.C.A. §§ 1395j-1395cec (West 1992 & Supp.1998). Generally, Medicare Part B covers “reasonable and necessary” medical services for the “diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” Id. §§ 1395k, 1395y(a)(1)(A). Though Medicare Part B does not cover most prescription medication, it does cover drugs, like Lupron and Zoladex, which are typically administered by doctors during office or hospital visits. Id. § 1395x(s)(2)(A). Medicare reimburses doctors for a percentage of the cost of such drugs. Id. §§ 1395k, 1395Z, 1395u(o)(l); 42 C.F.R. § 405.517(b) (1998).

In October 1996, Palmetto Government Benefits Administrators (Palmetto), which administers Medicare Part B benefits in South Carolina under the authority of the Health Care Financing Administration and the United States Department of Health and Human Services (collectively, the Government), adopted the policy that TAP seeks to challenge here. The policy provides that doctors will be reimbursed for the cost of Lupron only at the reimbursement level of the less-expensive Zoladex. Prior to its adoption, Palmetto reimbursed expenditures for each drug on the basis of that drug’s own cost.

Palmetto based this change in policy on its conclusion that “there is no therapeutic difference between” the two drugs, although it later acknowledged that TAP’s Lupron has a greater duration of action. In the most recent version of the Lupron policy, Palmetto states that “there is no demonstrable difference in clinical efficacy” between Lupron and Zola-dex. This latest version of the policy also loosens the restriction on Lupron reimbursement. It allows patients who wish to receive Lupron to make up the difference in cost between Lupron and Zoladex on their own, and it provides that “[i]f there are true medical indications requiring the use of [Lupron] instead of [Zoladex], Medicare will consider reimbursement for the difference in cost if an invoice and documentation of the medical necessity accompanies the claim.”

Palmetto maintains that the Medicare Carriers Manual authorized it to adopt the new Lupron policy. One provision of the Manual instructs carriers to pay for durable medical equipment (DME) at a level based on the least costly alternative where “medically appropriate and realistically feasible alternative pattern[s] of care” are available. Compl. at 5 (quoting Manual § 2100.2(B)). Another provision of the Manual states that carriers have “discretion” to apply the least costly alternative principle “to payment for non-DME items and services as well.” See id. (quoting Manual § 7505.1).

TAP alleges that the new Lupron reimbursement policy violates a Medicare regulation providing that reimbursement for drugs such as Lupron must be “based on the lower [202]*202of the estimated acquisition cost or the national wholesale average price of the drug.” 42 C.F.R.§ 405.517(b). TAP asserts that basing reimbursement for Lupron on the cost of Zoladex, rather than on the cost of Lupron itself, violates this regulation. Although the regulation has now been superseded by a 1997 amendment to the Act, which provides that payment for covered drugs is to be made at 95% of the average wholesale price, 42 U.S.C. § 1395(o)(1), TAP’s contention regarding the regulation applies equally well to the statute as amended.1 Both base reimbursement on the cost of the drug used, while the new Lupron policy bases reimbursement on the cost of another drug.

TAP also alleges that Palmetto adopted its Lupron policy without the notice and comment required by statute, see 5 U.S.C.A. § 553(West 1996); 42 U.S.C.A. § 1395hh(a)(2),(b) (West 1996); that Palmetto’s conclusion that “there is no therapeutic difference between” Lupron and Zoladex lacked a scientific basis and so its adoption of the new Lupron policy in reliance upon this conclusion was arbitrary and capricious, see 5 U.S.C.A. § 706(2); and finally that Palmetto’s reimbursement policy violated 42 U.S.C.A. § 1395y(a)(1)(A), which prohibits payment for any item that is not “reasonable and necessary.”

Without confronting the merits of these allegations, the Government moved to dismiss TAP’s complaint on three grounds. The Government argued (1) that TAP’s complaint did not meet prudential standing requirements; (2) that Medicare Part B statutorily precluded TAP’s complaint; and (3) that TAP lacked Article III standing. The district court dismissed TAP’s complaint based solely on the first of these contentions, finding that the company did not satisfy the prudential standing requirements and therefore had no right to challenge the Lupron policy in court. In light of our resolution of this appeal, we too need only address the first issue.

II.

The Administrative Procedure Act (APA) provides that “[a] person suffering legal wrong, or adversely affected or aggrieved by agency action within the meaning of a relevant statute, is entitled to judicial review thereof.” 5 U.S.C.A. § 702 (West 1996).

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Cite This Page — Counsel Stack

Bluebook (online)
163 F.3d 199, 1998 U.S. App. LEXIS 30447, 1998 WL 823504, Counsel Stack Legal Research, https://law.counselstack.com/opinion/tap-pharmaceuticals-v-us-department-of-health-human-services-health-ca4-1998.