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PUBLIC CITIZEN, INC. v. DEPARTMENT OF HEALTH AND HUMAN SERVICES

July 9, 2001

PUBLIC CITIZEN, INC. PLAINTIFF,
v.
DEPARTMENT OF HEALTH AND HUMAN SERVICES, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Ellen Segal Huvelle, United States District Judge.

  MEMORANDUM OPINION
Plaintiff Public Citizen, Inc. has sued the Department of Health and Human Services ("HHS") and the Health Care Financing Administration ("HCFA") under the Administrative Procedures Act ("APA"). Plaintiff alleges that HCFA's regulations and its Peer Review Organization Manual ("PRO Manual"), which prohibit disclosure by a PRO of the final disposition of its investigation of a complaint brought by a beneficiary of the Medicare system if that information identifies a practitioner who does not consent to disclosure, are contrary to the Peer Review Improvement Act of 1982, 42 U.S.C. § 1320c, et seq. Defendants respond that the maintenance of the confidentiality of such information absent practitioner consent is both consistent with the statute and necessary to a PRO's ability to perform its duties and to evaluate doctors who have been the subject of a beneficiary complaint. Both parties have moved for summary judgment. Based on the pleadings and the entire record herein,*fn1 the Court grants plaintiff's motion for summary judgment, and denies defendants' motion.

BACKGROUND

On August 7, 2000, the PRO sent Mr. Shipp three letters. One letter reported that the PRO had completed its investigation of the health care services provided by Dr. Thurman, and concluded that "[n]o quality of care issues were identified with the services provided by Dr. Thurman. It has been determined that the examination your wife received on March 24, 1999, was appropriate and not expected to reveal the cecal cancer diagnosis that was later discovered." (R. 9.) Dr. Thurman apparently consented to the release of that information, which as discussed below, under the relevant HCFA regulations would not be released without his consent.
A second letter addressed Mr. Shipp's complaints regarding Dr. Dedman. (R. 5.) This letter reported that "[b]efore providing this response, we gave Dr. Thomas Dedman an opportunity to review the information and provide comments." (Id. (emphasis in original)). The letter informed Mr. Shipp:
We have carefully examined all the issues raised in your correspondence and conducted a thorough review of the care your wife received. Federal laws and regulations prohibit us from releasing information about your care without the consent of your physician. Your wife's physician did not give consent; therefore, we are unable to provide any specific information about the results of our review. Our inability to provide this information does not mean that we found any problem with the care she received. However, please be assured that if we did find a problem, we will take all necessary action when our review findings warrant it.
(Id.) The letter concerning Dr. Jolgren also reported that Dr. Jolgren did not consent to the release of information concerning his care of Mrs. Shipp, and provided this same explanation. (R. 7.)

STATUTORY FRAMEWORK

The Peer Review Improvement Act of 1982 created the Medicare Utilization Quality Control Peer Review Organization Program ("PRO program") to oversee the administration of health services provided under Medicare. Under the PRO program, HCFA, an agency within HHS, contracts with private organizations composed of licensed physicians to provide peer review services to the government. See 42 U.S.C. § 1320c-2(b) (West 1991). The PROs review health care services provided under Medicare to insure that they are reasonable and medically necessary, and that the quality of the services meets the appropriate standard of care. See 42 U.S.C. § 1320c-3(a)(1) (West Supp. 2000). PROs must comply with the Peer Review Improvement Act and the implementing HCFA regulations, as well as the contract governing the relationship between the PRO and HCFA. HCFA has also issued a PRO Manual. (See R. 11-29.) Under the Act, PROs are required to investigate complaints made by Medicare beneficiaries and their representatives about the quality of care given by a Medicare funded provider. 42 U.S.C. § 1320c-3(a)(14) (West Supp. 2000) (PROs "shall conduct an appropriate review of all written complaints about the quality of services . . . not meeting professionally recognized standards of health care, if the complaint is filed with the organization by an individual entitled to benefits for such services under such subchapter. . . ."). The statute further provides that "[t]he organization shall inform the individual (or representative) of the organization's final disposition of the complaint. Before the organization concludes that the quality of services does not meet professionally recognized standards of health care, the organization must provide the practitioner or person concerned with reasonable notice and opportunity for discussion." 42 U.S.C. § 1320c-3(a)(14) (emphasis added). It is this provision which is at issue here.
The statute also provides that "[a]ny data or information acquired by [a PRO] in the exercise of its duties and functions shall be held in confidence and shall not be disclosed to any person" except under certain delineated circumstances (42 U.S.C. § 1320c-9(b)), as well as "to the extent that may be necessary to carry out the purposes of this part." 42 U.S.C. § 1320c-9(a)(1) (West Supp. 2000). However, the disclosure of information is also permitted "in such cases and under such circumstances as the Secretary shall by regulations provide to assure adequate protection of the rights and interests of patients, health care practitioners, or providers of health care." 42 U.S.C. § 1320c-9(a)(2) (West Supp. 2000). In addition, the statute permits the disclosure of information, in accordance with certain safeguards and procedures, "which may identify specific providers or practitioners as may be necessary" to assist Federal and State agencies with responsibility for investigating cases of fraud or abuse, identifying public health risks, and licensing and certification of health care providers. 42 U.S.C. § 1320c-9(b)(1) (West Supp. 2000). Finally, certain materials are exempt from discovery in civil legal proceedings:
No patient record in the possession of an organization having a contract with the Secretary under this part shall be subject to subpoena or discovery proceedings in a civil action. No document or other information produced by such an organization in connection with its deliberations in making determinations under section 1320c-3(a)(1)(B) or 1320c-5(a)(2) of this title shall be subject to subpoena or discovery in any administrative or civil proceeding; except that such an organization shall provide, upon request of a practitioner or other person adversely affected by such a determination, a summary of the organization's findings and conclusions in making the determination.

42 U.S.C. § 1320c-9(d) (West Supp. 2000).

Under regulations promulgated by HCFA pursuant to the delegation in 42 U.S.C. § 1320c-9(a)(2), HCFA defines "confidential information" to include "(1) Information that explicitly or implicitly identifies an individual patient, practitioner or reviewer; (2) Sanction reports and recommendations; (3) Quality review studies which identify patients, practitioners or institutions; (4) PRO deliberations." 42 C.F.R. § 480.101(b) (2000). Under the regulations, "[i]mplicitly identify(ies) means data so unique or numbers so small so that identification of an individual patient, practitioners or reviewer would be obvious." Id. The regulations incorporate the statutory bases for disclosure of confidential information enumerated in § 1320c-9(a) and (b). 42 C.F.R. § 480.103 (2000).*fn2 The regulations also provide that "[a] PRO may disclose to any person, agency or organization, information on a particular practitioner or reviewer with the consent of that practitioner or reviewer provided that the information does not identify other individuals." 42 C.F.R. § 480.133(a)(2)(iii) (2000) (emphasis added). These regulations were issued on April 17, 1985, and became effective on May 17, 1985. A year after these regulations were promulgated, Congress amended the Act in October 1986 to require PROs to investigate all beneficiary complaints about quality of care, and to report to the beneficiary "the organization's final disposition of the complaint." 42 U.S.C. § 1320c-3(a)(14).*fn3

Pursuant to the regulations it had promulgated prior to the enactment of § 1320c-3(a)(14), defendants have applied this provision to prohibit the disclosure of information which identifies a practitioner without that practitioner's consent.*fn4 Plaintiff argues that § 1320c-3(a)(14) requires PROs to inform a beneficiary complainant whether quality of care issues were identified as to a particular practitioner and that HCFA regulations prohibiting such disclosure are contrary to the statute. Plaintiff contends that the intent of Congress in enacting the amendment in 1986 to require a PRO to disclose to the beneficiary the result of its investigation is clear and unambiguous, and notwithstanding the delegation of authority to HHS to implement regulations with respect to confidentiality, disclosure is required by § 1320c-3(a)(14) and permitted by 42 U.S.C. § 1320c-9(a)(1), which provides that a PRO may disclose information "to the extent that may be necessary to carry out the purposes of this part." Plaintiff also contends that even if the statute is found to be ambiguous, defendants' interpretation is unreasonable.

Defendants respond by arguing that § 1320c-3(a)(14) should be interpreted to require "only that PROs inform beneficiary complainants that their complaint was received, that it was investigated, and that corrective action was taken if appropriate." Def. Cross Mot. at 20. Defendants further contend that Congress intended that practitioner-identifying information be disclosed only where expressly permitted by the statute in § 1320c-9(b), or where the Secretary, in promulgating regulations governing confidentiality and disclosure of information under the statute, has determined such disclosures to be justified. Defendants therefore argue that the regulations prohibiting disclosure of practitioner-identifying information are consistent with ยง 1320c-3(a)(14). Alternatively, defendants argue that the statute is ambiguous in what is meant by "the final disposition of the ...

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