UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

PUBLIC CITIZEN, INC.,

                                Plaintiff,

                        v.

DEPARTMENT OF HEALTH
AND HUMAN SERVICES,

                       and

HEALTH CARE FINANCING
ADMINISTRATION,

                                Defendants.

                                                        

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)         Civil Action No. 00-0731 (ESH)
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FIRST AMENDED COMPLAINT FOR
DECLARATORY AND INJUNCTIVE RELIEF

1. This action is brought under the Administrative Procedure Act, 5 U.S.C. § 706(2)(A), and arises from defendants' regulation and policy of prohibiting Peer Review Organizations ("PRO") from releasing the results of investigations of complaints about the quality of health care services, in violation of 42 U.S.C. § 1320c-3(a)(14).

Jurisdiction

2. This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1331 and § 1361.

Parties

3. Plaintiff Public Citizen, Inc. ("Public Citizen") is a non-profit public interest organization organized under the laws of the District of Columbia, with its principal office in the District of Columbia. Founded in 1971, Public Citizen's objectives include fighting for safe and effective drugs and medical devices, for responsible controls over the delivery of health care, and for informed consent and public access to health care information. Public Citizen brings this action on behalf of its 150,000 members throughout the United States, a substantial proportion of whom are 65 years of age or older, and thus eligible for Medicare.

4. Defendant Department of Health and Human Services ("HHS") is the federal agency charged by Congress with contracting with PROs and establishing the policies under which PROs conduct their statutory functions, including promulgating regulations and setting policy governing the disclosure of information acquired by PROs in the course of carrying out their functions.

5. Defendant Health Care Financing Administration ("HCFA") is a federal agency within HHS. HCFA has issued a Peer Review Organization Manual ("Manual") that directs PROs not to disclose to complainants the results of their investigations if doing so would implicitly or explicitly identify a practitioner who did not consent to disclosure. HCFA is also responsible for promulgating regulations that prohibit disclosure of the results of PRO investigations if doing so would implicitly or explicitly identify a practitioner who did not consent to disclosure.

Statutory and Regulatory Background

6. Section 1320c-3 of Title 42 lists the functions of PROs that enter into contracts with the Secretary of HHS. The statute requires, in part, that PROs conduct reviews of all written complaints about the quality of health care services by an individual entitled to benefits for such services or that individual's representative. 42 U.S.C. § 1320c-3(a)(14). Once a review is completed, the statute provides that the PRO "shall inform the [complainant] of the organization's final disposition of the complaint." Id.

7. Under 42 U.S.C. § 1320c-9(a)(2), HHS has the authority to promulgate regulations to assure adequate protection of the rights and interests of patients, health care practitioners, and providers of health care.

8. Notwithstanding 42 U.S.C. § 1320c-3(a)(14), HCFA's regulations provide that "[i]nformation that explicitly or implicitly identifies an individual . . . practitioner" is "confidential information." 42 C.F.R. § 476.101(b)(1). In addition, HCFA's regulations 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. § 476.133(a)(2)(ii)(B)(iii).

9. Notwithstanding 42 U.S.C. § 1320c-3(a)(14), the Manual published by HCFA states that PROs are prohibited from disclosing the results of their investigations if doing so would implicitly or explicitly identify a practitioner who did not consent to disclosure. Defendants have recently made certain changes to the Manual which confirm this policy.

10. Defendants' conduct, as complained of herein, has harmed, continues to harm, and threatens to harm in the future Public Citizen members by denying them their statutory right to receive the results of PRO investigations. For example, on December 6, 1999, Public Citizen member David Shipp requested that Health Care Excel, a PRO in Indiana, review the quality of care received by his wife. In a letter dated August 7, 2000, Health Care Excel wrote to Mr. Shipp that "[f]ederal law and regulations prohibit us from releasing information about your [sic] care without the consent of your [sic] physician. Your wife's physician did not give consent; therefore we are unable to provide any specific information about the results of our review." Without the injunctive relief requested herein, David Shipp and other Public Citizen members will suffer irreparable harm.

Claim for Relief

11. Plaintiff reasserts and incorporates herein by reference the allegations contained in paragraphs 1-10 above, as though fully set forth herein.

12. Defendants' conduct, though the Manual and regulations, in prohibiting PROs from disclosing the results of PRO investigations if doing so would implicitly or explicitly identify a practitioner who did not consent to disclosure violates 42 U.S.C. § 1320c-3(a)(14) and the Administrative Procedure Act, 5 U.S.C. § 706(2)(A).

WHEREFORE, plaintiff prays for an order:

(1) Declaring that HCFA's regulations prohibiting disclosure of the results of PRO investigations when doing so would implicitly or explicitly identify a practitioner who did not consent to disclosure are invalid because they violate 42 U.S.C. § 1320c-3(a)(14);

(2) Declaring that defendants' policy prohibiting PROs from disclosing the results of PRO investigations when doing so would implicitly or explicitly identify a practitioner who did not consent to disclosure violates 42 U.S.C. § 1320c-3(a)(14);

(3) Directing defendants immediately to retract the Manual's direction regarding disclosure and to inform PROs that they must disclose the results of PRO investigations, regardless of whether doing so would implicitly or explicitly identify a practitioner who did not consent to disclosure;

(4) Granting plaintiff its attorney's fees and costs reasonably accrued; and

(5) Granting plaintiff such other relief as may be just and proper.

 

Dated: January 19, 2001 ______________________________

Allison M. Zieve (D.C. Bar No. 424786)
Amanda Frost (D.C. Bar. No. 467425)
Public Citizen Litigation Group
1600 20th Street, NW
Washington, DC 20009
(202) 588-1000

Counsel for Plaintiff