manufactures and distributes medical devices, including instruments used in lumbar spinal fusion surgery to treat spinal disorders. Complaint, P 7.
The Agency for Health Care Policy and Research (AHCPR) is an agency of the United States Public Health Service, Department of Health and Human Services. Congress established the AHCPR in the Omnibus Budget Reconciliation Act of 1989 (OBRA), Pub. L. No. 101-239, § 901, 103 Stat. 2189 (1989), which amended the Public Health Service Act, 42 U.S.C. §§ 1301 - 1395ccc.
Congress intended the AHCPR to improve the quality, appropriateness, and effectiveness of health care services, and to improve access to such services. 42 U.S.C. § 299(b). To carry out that objective, Congress directed the AHCPR to facilitate development of CPGs, guidelines that would establish parameters for diagnosing, treating, managing, and preventing selected conditions. 42 U.S.C. § 2(a).
Congress required that the CPGs be based on a comprehensive review of the best scientific research and professional judgment and that they be presented in formats appropriate for use by physicians, health care practitioners and providers, medical educators, and medical review organizations. 42 U.S.C. § 299b-1(b). The AHCPR defines clinical practice guidelines (CPGs) as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." AHCPR Program Note (August 1993) at 1, Attached as Exhibit 1 to Defendants' Motion for Summary Judgment.
Congress in the OBRA also established the Forum for Quality and Effectiveness in Health Care (Forum). Through the Forum, the AHCPR oversees the development, periodic review and updating of the CPGs. 42 U.S.C. § 299b. Based on the guidelines produced, the Forum oversees development of medical review criteria, standards of quality, and performance measures which assist health care providers to assess or review the provision of health care. AHCPR Program Note, supra, at 1.
Congress directed the AHCPR to develop CPGs through the establishment and operation of panels of medical experts and consumers. 42 U.S.C. § 299b-2. The AHCPR facilitates the development of CPGs in two ways: it either itself convenes multidisciplinary private-sector panels of experts and health care consumers, or it contracts with public or private nonprofit organizations to convene panels of experts. AHCPR Program Note, supra, at 2.
On March 18, 1991, the AHCPR announced in the Federal Register that it was establishing a panel of experts and health care consumers to develop clinical practice guidelines for low back disorders and related conditions and invited nominations of qualified individuals to serve as chairperson(s) and as panel members. 52 Fed. Reg. 11452 (March 18, 1991).
On April 22, 1992, Dr. James Mason, Assistant Secretary for Health at HHS announced the formation of an AHCPR sponsored 23-member panel of private-sector health care experts and consumers to develop clinical practice guidelines for diagnosing and treating low back problems.
On July 24, 1992, the AHCPR announced in the Federal Register that a public meeting would be held on September 16, 1992 to receive comments and information pertaining to the development of the clinical practice guidelines on Low Back Problems. 57 Fed. Reg. 32991 (July 24, 1992).
Sofamor Danek, by letter from its counsel dated November 1, 1993, informed the AHCPR that it believed the Expert Panels convened to develop clinical practice guidelines, including the Low Back Problems Panel, were advisory committees subject to the procedures and requirements of the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2.
In a letter to Sofamor Danek dated November 10, 1993, Dr. Jarrett Clinton, then the Administrator of AHCPR, stated that the clinical practice guideline panels are not advisory committees within the meaning of FACA and therefore not subject to FACA's procedural requirements. Representatives of Sofamor Danek and the Department of Health and Human Services met on March 28, 1994. By letter dated April 29, 1994, Beverly Dennis, the Deputy General Counsel at HHS, informed counsel for Sofamor Danek that it continued to be HHS's opinion that the clinical guideline panels are not advisory committees within the meaning of FACA.
After more than two years of work and study, the Low Back Problems Panel has now completed the development of the CPG on low back problems. Along with the CPGs, the AHCPR will publish and disseminate a Quick Reference Guide for Physicians and a Patient's Guide. The AHCPR will publish and disseminate the CPG on low back problems and its accompanying documents without charge to physicians, health care practitioners and providers, medical educators, and medical review organizations. The CPG on low back problems will also be available through the AHCPR Publications Clearinghouse. Individuals or organizations may call a toll-free number or write the Clearinghouse, and the Clearinghouse will send the CPG, the Clinician's Guide, or the Patient Guide to the requestor without charge. Expenses of the Clearinghouse, the toll-free number, and the printing and dissemination of CPG documents are borne by the AHCPR. Deposition of Carole Hudgings at 83 - 84; AHCPR Program Note, supra, at 4.
The Government has formally notified the Court that it intends to release the Low Back CPG on December 8, 1994.
III. Plaintiff's Motion For Summary Judgment Must Be Denied, and Defendants' Motion for Summary Judgment Must Be Granted
A. Statutory Background
Congress enacted FACA in 1972 to control the growth and ensure openness of operation of the "numerous committees, boards, commissions, councils and similar groups which have been established to advise officers and agencies in the executive branch of the Federal Government." 5 U.S.C. App. 2 § 2(a); see generally Public Citizen v. Department of Justice, 491 U.S. 440, 466, 105 L. Ed. 2d 377, 109 S. Ct. 2558 (1989). To achieve these objectives, the FACA places a number of procedural restrictions on those bodies that constitute "advisory committees."
The statute defines an advisory committee as follows:
Any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof (hereafter in this paragraph referred to as "committee"), which is --
(A) established by statute or reorganization plan, or