Public Citizen, Inc. v. U.S. Department of Health & Human Services

332 F.3d 654, 357 U.S. App. D.C. 1, 2003 U.S. App. LEXIS 12719
CourtCourt of Appeals for the D.C. Circuit
DecidedJune 20, 2003
DocketNos. 01-5294 & 01-5298
StatusPublished
Cited by54 cases

This text of 332 F.3d 654 (Public Citizen, Inc. v. U.S. Department of Health & Human Services) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Public Citizen, Inc. v. U.S. Department of Health & Human Services, 332 F.3d 654, 357 U.S. App. D.C. 1, 2003 U.S. App. LEXIS 12719 (D.C. Cir. 2003).

Opinion

Opinion for the Court filed by GARLAND, Circuit Judge.

GARLAND, Circuit Judge:

When a Medicare beneficiary files a complaint with a Peer Review Organization (PRO) about the quality of medical services that he or she has received, the Peer Review Improvement Act requires the PRO to “inform the individual ... of the organization’s final disposition of the complaint.” 42 U.S.C. § 1320c-3(a)(14). According to the Health Care Financing Administration (HCFA) of the Department of Health and Human Sendees (HHS), a PRO can comply with this requirement by sending the complainant a form letter that merely states that the PRO has examined the complainant’s concerns and that it will take appropriate action if warranted.1 Indeed, if the complainant’s health care practitioner objects to the PRO providing information that explicitly or implicitly identifies the practi[3]*3tioner, HCFA bars the PRO from saying anything more.

We conclude that the statutory command to inform a complainant of the “final disposition” of the complaint requires more than what HCFA currently permits. At a minimum, it requires the organization to notify the complainant of the results of its review. We therefore affirm the district court’s order invalidating those provisions of the Department’s Peer Review Organization Manual that bar PROs from providing such information to complaining beneficiaries.

I

A

In 1982, Congress amended the Social Security Act by enacting the Peer Review Improvement Act of 1982, Pub.L. No. 97-248 §§ 141-150, 96 Stat. 324 (1982) (codified as amended at 42 U.S.C. § 1320c et seq.). The 1982 Act called for HHS to contract with PROs to perform a range of quality improvement and professional review activities. PROs are private, geographically based organizations composed of licensed doctors “engaged in the practice of medicine or surgery in the area.” 42 U.S.C. § 1320C-1. HCFA contracts with PROs to review the quality, reasonableness, and efficiency of medical services provided under Medicare, as well as to determine whether the services provided are within Medicare’s statutory coverage. Id. § 1320c — 3(a)(1); see also id. § 1395y(g).

Section 1320c-3(a)(l) of the statute requires each PRO to “review some or all of the professional activities” of physicians and other providers of services for which payment may be made under Medicare. Id. § 1320c-3(a)(l). The statute also contains a number of confidentiality provisions, including § 1320c-9(a), which states:

Any data or information acquired by any such organization in the exercise of its duties and functions shall be held in confidence and shall not be disclosed to any person except — (1) to the extent ... necessary to carry out the purposes of this part, (2) 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, or (3) in accordance with [provisions permitting specified disclosures to federal and state agencies].

42 U.S.C. § 1320c-9(a).

On April 17, 1985, pursuant to the delegation of authority contained in § 1320c-(9)(a)(2), HCFA issued regulations defining “confidential information” to include: “(1) Information that explicitly or implicitly identifies an individual patient, practitioner or reviewer[;] (2) Sanction reports and reeommendations[;] (3) Quality review studies which identify patients, practitioners or institutions^ and] (4) PRO deliberations.” 42 C.F.R. § 480.101(b). The regulations, however, also incorporate the statutory exceptions for disclosure of confidential information enumerated in § 1320e-9(a)(l) & (3) and set out above. 42 C.F.R. § 480.103. They further 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.” Id. § 480.133(a)(2)(iii). The regulations became effective on May 17, 1985, and have not changed in relevant part since that time. Compare 42 C.F.R. §§ 476.101(b), 476.103, 476.133 (1985), with 42 C.F.R. §§ 480.101(b), 480.103, 480.133 (2002).

In October 1986, approximately a year and a half after HCFA promulgated its [4]*4confidentiality regulations, Congress amended § 1320c-3 to impose upon PROs the further duty that is specifically at issue in this case. The new section, § 1320c-3(a)(14), provides as follows:

The organization 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 ... (or a person acting on the individual’s behalf). The 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). HHS has not promulgated any regulation that implements or addresses § 1320c-3(a)(14).

B

On December 15, 1998, Doris Shipp went to Baptist East Hospital in Louisville, Kentucky, complaining of abdominal pain. Over the next few months, Mrs. Shipp was seen by Drs. Peter Thurman, Thomas C. Dedman, and David Jolgren. Mrs. Shipp died of cancer in June 1999. On December 6, 1999, her husband, David Shipp, wrote to Health Care Excel (Excel), the PRO responsible for monitoring the delivery of Medicare services in Kentucky, and asked Excel to investigate and respond to his concerns about the quality of care that his wife had received.

In response, Excel sent Mr. Shipp three letters- — one for each of the three physicians — entitled “Notice: Quality of Care Determination.” The first letter, concerning Dr. Thurman, informed Shipp that “[n]o quality of care concerns were identified with the services provided by Dr. Thurman,” and that “[i]t 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 discovered later.” J.A. 58.

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Bluebook (online)
332 F.3d 654, 357 U.S. App. D.C. 1, 2003 U.S. App. LEXIS 12719, Counsel Stack Legal Research, https://law.counselstack.com/opinion/public-citizen-inc-v-us-department-of-health-human-services-cadc-2003.