UNITED STATES DISTRICT COURT
MEMORANDUM IN SUPPORT OF
The Peer Review Improvement Act mandates that Peer Review Organizations ("PROs") investigate all written complaints about the quality of medical care received by Medicare beneficiaries and then disclose to the complainant the "final disposition of the complaint." 42 U.S.C. § 1320c-3(a)(14). The Act's disclosure requirement is without exception. Nonetheless, the Health Care Financing Administration ("HCFA") directs PROs to withhold the final disposition of investigations into beneficiary complaints if that information identifies a practitioner who does not consent to disclosure. As a result, complainants have been in the past, and will be in the future, denied their statutory right to obtain the results of investigations. Because HCFA's policy is contrary to law, this Court should declare the HCFA regulations and provisions of HCFA's PRO Manual prohibiting disclosure to be invalid and order HCFA to instruct PROs to disclose the final dispositions of their investigations to complainants.
STATEMENT OF FACTS
A. Regulatory and Statutory Background
In the Peer Review Improvement Act of 1982, Congress created the Medicare Utilization and Quality Control Peer Review Organization Program ("PRO Program") to oversee the administration of health care services under Medicare. 42 U.S.C. § 1320c, et seq. The PRO Program is designed to monitor and improve utilization and quality of care for Medicare beneficiaries through a national network of 53 PROs. See <http://www.hcfa.gov/quality/5b.htm> (last visited Mar. 5, 2001). PROs are staffed with experts in medicine, quality improvement, health information management, and statistical analysis who review the quality and propriety of Medicare services within their jurisdictions. Id. Although the PRO program is administered by HCFA, an agency within the Department of Health and Human Services ("HHS"), the PROs themselves are private entities that provide services for the federal government on a contractual basis. 42 U.S.C. §§ 1320c-1 to -2(b).
PROs are heavily regulated by federal law. They must comply with requirements of the Peer Review Improvement Act, HCFA regulations implementing that Act, their contracts with HHS, and the directives issued by HCFA concerning the performance of their duties. 42 U.S.C. § 1320c-3(a)(8); 42 C.F.R. § 466.74(a); Current Contract Between HCFA and PROs § C.4.0 (Administrative Record ("R") 94). HCFA has overall policy-making responsibility for the administration of the PRO program and controls nearly every aspect of PROs' daily operations through its Peer Review Organization Manual ("PRO Manual" or "Manual"). PRO Manual § 1015(B).
Under the Act, PROs are responsible for investigating all written complaints by Medicare beneficiaries and their representatives about the quality of services received by the beneficiaries. 42 U.S.C. § 1320c-3(a)(14). PROs must determine whether that care meets the "professionally recognized standards of health care" and must take corrective action if the standard has not been met. Id.
At issue in this case is the Act's requirement that PROs disclose to complainants the "final disposition of the complaint." Id. The relevant provision of the statute provides as follows:
42 U.S.C. § 1320c-3(a)(14) (emphasis added).
Despite the statutory requirement that PROs inform complainants of the final disposition of their complaints, HCFA has promulgated regulations and issued directions in its PRO Manual prohibiting PROs from disclosing the final disposition of investigations when that information explicitly or implicitly identifies a practitioner who does not consent to disclosure.
Two HCFA regulations prohibit disclosure of the results of PRO investigations under certain circumstances. One regulation defines "confidential information" to include "[i]nformation that explicitly or implicitly identifies an individual . . . practitioner." 42 C.F.R. § 480.101(b). "Implicitly identify(ies)" is defined as "data so unique or numbers so small that identification of an individual . . . practitioners [sic] . . . would be obvious." Id. Another regulation permits disclosure of information about an individual practitioner only if that practitioner consents. The relevant provisions of that regulation states:
42 C.F.R. § 480.133(a)(2)(iii). Together, these two regulations prohibit PROs from disclosing the final disposition of their investigations if doing so would explicitly or implicitly identify a practitioner who did not consent to disclosure. Nowhere do HCFA's regulations specifically recognize 42 U.S.C. § 1320c-3(a)(14)'s requirement that PROs disclose the final disposition of its investigation into beneficiary complaints.
In its PRO Manual, HCFA cites its regulations as the basis for its policy of nondisclosure of the final disposition of PRO investigations. Section 5035 of the manual, which addresses "Disclosure of Quality Review Information to Complainants," states that "[d]isclosure of PRO quality review information is governed by federal confidentiality regulations at 42 C.F.R. Part 480." (R. 21). In accordance with these regulations, the Manual provides that "[i]nformation that explicitly or implicitly identifies a practitioner is confidential and may not be disclosed without the practitioner's consent." PRO Manual § 5035(B) (R. 22).
Section 5030 of the Manual, which describes PROs' "Final Response to Complaints," requires PROs to disclose the final disposition of their investigation except when that information identifies a practitioner, in which case disclosure is prohibited. (R. 19). If the results of an investigation do not explicitly or implicitly identify a practitioner, the Manual directs PROs to (1) "[a]dvise the complainant whether the care received meets recognized standards of quality and give a complete fact-specific summary of your review findings" and (2) "[d]etail the action you are initiating or will initiate if you confirm a quality concern. Provide specifics, when appropriate." PRO Manual § 5030(B) (R. 20). However, if the final disposition of an investigation identifies a practitioner, the PRO is directed to withhold that information, and instead "[e]xplain that you are unable to provide any information that explicitly or implicitly identifies the involved practitioner because applicable regulations prohibit the release of such information without the involved practitioner's consent." PRO Manual § 5030(C) (R. 20).
The PRO Manual contains a number of model letters that HCFA has instructed PROs to use as guidance when communicating with complainants. One such letter provides the model response that PROs are to follow when informing a complainant that, because a practitioner identified by its investigation does not consent to disclosure, the PRO cannot inform the beneficiary of the results of the investigation. PRO Manual Exhibit 5-17 (R. 28-29). That letter states:
Id. (R. 29) (emphasis in original).
Like the regulations, HCFA's PRO Manual does not cite or discuss 42 U.S.C. § 1320c-3(a)(14)'s mandate that PRO disclose the "final disposition" of investigations to complainants.
Plaintiff Public Citizen, Inc. is a non-profit consumer advocacy organization founded in 1971. Declaration of Lane Brooks, attached as Exhibit A ("Brooks Decl.") ¶ 2. 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. Brooks Decl. ¶¶ 3, 4. Public Citizen brings this action on behalf of its 140,000 members throughout the United States, a substantial proportion of whom are 65 years of age or older, and thus eligible for Medicare. Brooks Decl. ¶¶ 5, 6. HCFA's policy and regulations prohibiting PROs from providing complainants with the final disposition of PRO investigations without the consent of an identified practitioner threatens to harm these members by denying them their statutory right to such information.
For example, on December 15, 1998, Doris Shipp, the wife of Public Citizen member David Shipp, went to Baptist East Hospital in Louisville, Kentucky, complaining of abdominal pain. See Letter from D. Shipp to Health Care Excel, Dec. 6, 1999 (R. 2). Over the next few days, Ms. Shipp was seen by Dr. Peter Thurman, Dr. Thomas C. Dedman, and Dr. David Jolgren Id. Ms. Shipp died of cancer on June 21, 1999. Id. (R. 1). After his wife's death, Mr. Shipp had many questions and concerns about the quality of care his wife had received. On December 6, 1999, Mr. Shipp wrote to Health Care Excel, the PRO responsible for monitoring the delivery of Medicare services in Kentucky, and listed his concerns. Id. (R. 1-3). Mr. Shipp requested that the PRO "investigate" and "respond" to his concerns. Id. (R. 3).
On August 7, 2000, after completing its investigation, the PRO sent Mr. Shipp three letters. The first letter concerned Dr. Peter Thurman, who apparently did not object to disclosure of the PRO's final disposition of its investigation into the quality of the care that he provided to Ms. Shipp. See Letter from R. Hojnicki, Health Care Excel, to D. Shipp, concerning Dr. Thurman, Aug. 7, 2000 (R. 9). Thus, the PRO disclosed to Mr. Shipp its conclusion that "[n]o quality of care concerns 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." Id.
The second letter responded to Mr. Shipp's concerns about the care delivered by Dr. Thomas Dedman, Ms. Shipp's surgeon. See Letter from R. Hojnicki, Health Care Excel, to D. Shipp, concerning Dr. Dedman, Aug. 7, 2000 (R. 5). The PRO informed Mr. Shipp that "[b]efore providing this response, we gave Dr. Thomas Dedman an opportunity to review the information and provide comments." Id. (underlining in original). Although Dr. Dedman was provided with the PRO's final disposition of its investigation, Mr. Shipp was not. Instead, the PRO informed Mr. Shipp that:
Id. Mr. Shipp received an identical letter denying him the results of the PRO's investigation into the care provided by Dr. David Jolgren. See Letter from R. Hojnicki, Health Care Excel to D. Shipp, concerning Dr. Jolgren, Aug. 7, 2000 (R. 7).
C. Procedural Background
On April 5, 2000, the complaint in this case was filed on behalf of Alan Levine and Public Citizen. Mr. Levine had been denied the results of a Florida PRO's investigation into the quality of care his mother had received while staying at a hospital in Florida. Like Public Citizen member David Shipp, Mr. Levine received a letter from the Florida PRO informing him that "[f]ederal law and regulations" prohibited it from informing Mr. Levine of the results of its investigations because the practitioner involved, Dr. Richard Boehme, did not consent to disclosure. See Complaint (April 5, 2000) ¶ 13.
After plaintiffs filed their motion for summary judgment on September 8, 2000, defendants HCFA and HHS requested a three-month stay, during which time they promised to clarify the PRO Manual and to arrange that Mr. Levine be provided with the results of the Florida PRO's investigation. See Defs' Motion for Temporary Stay at 3-4 (Oct. 18, 2000). In December 2000, the Florida PRO informed Mr. Levine that its original decision to deny him the results of its investigation had been in error because the results would not identify a practitioner. See Notice of Withdrawal of Defs' Opp. to Pls' Motion for Leave to File Amended Complaint, Exhibit 2. The PRO then informed Mr. Levine of its final disposition of his complaint, that is, that it had concluded that the care provided to Mr. Levine's mother had not met the quality of care standard because she had been given a medication to which she had a documented allergy and that it had notified the hospital of its concern regarding this substandard care. Id.
On January 22, 2001, HCFA released a revised PRO Manual. See Peer Review Organization Manual Part 5 --Beneficiary Complaint Review, Dec. 21, 2000 (R. 11). The revised Manual did not contain any substantive changes, but rather made clearer that PROs should disclose the results of investigations if doing so would not identify a nonconsenting practitioner. For example, if the results identify a provider (such as a hospital or medical center), but do not implicitly or explicitly identify a practitioner, then the results can be disclosed even if an involved practitioner does not consent to disclosure. As described in part A, above, the revised PRO Manual continues to bar PROs from disclosing the final disposition of investigations if doing so would explicitly or implicitly identify a practitioner who does not consent to disclosure.
On February 7, 2001, the Court granted plaintiffs' motion to amend the complaint in this case. The amended complaint no longer lists Mr. Levine as a plaintiff, as the Florida PRO informed him of the final disposition of the investigation into his complaint. Public Citizen, however, continues to challenge defendants' policy of prohibiting PROs from disclosing the final disposition of their investigations when that information identifies a practitioner who does not consent to disclosure.
Under Federal Rule of Civil Procedure 56(c), summary judgment shall be granted when "there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." See Washington Post v. HHS, 865 F.2d 320, 325 (D.C. Cir. 1989). The issue in this case is whether HCFA's PRO Manual and regulations directing PROs to withhold the results of investigations from complainants absent the identified practitioners' consent violates the Peer Review Improvement Act, as amended, and thus should be held unlawful as "arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with the law." 5 U.S.C. § 706(2)(a). This question of law is properly resolved on summary judgment.
HCFA's Regulations And The Provisions In HCFA's PRO Manual Prohibiting
The Peer Review Improvement Act unequivocally states that PROs "shall inform the individual (or representative) of the organization's final disposition of the complaint." 42 U.S.C. § 1320c-3(a)(14). That provision is mandatory and without exception.(1)
The term "final disposition" means final determination or decision. See Black's Law Dictionary 567 (5th ed. 1979) ("final disposition" is "a conclusive determination of the subject-matter" of case; reader referred to nearly identical definition of "final decision"). Congress' use of the term "final disposition" is consistent with that definition. See, e.g., 28 U.S.C. § 2263(b)(1) (referring to the Supreme Court's "final disposition" of a petition for a writ of certiorari); 29 U.S.C. § 661(j) ("A[n] administrative law judge . . . shall hear, and make a determination upon, any proceedings instituted before the Commission . . . and shall make a report of any determination which constitutes his final disposition of the proceedings . . . ."). Courts frequently refer to the outcome and reasoning of their judicial opinions as "dispositions." See, e.g., United States v. Rosenberg, 888 F.2d 1406, 1424 (D.C. Cir. 1989) (dissent) ("the majority's disposition of this case reintroduces the actual-evidence test into double-jeopardy analysis"); Leahy v. District of Columbia, 833 F.2d 1046, 1048 (D.C. Cir. 1987) (referring to the "fragmented character of the Supreme Court's disposition in Roy [v. Bowen, 476 U.S. 693 (1986)]"); Brock ex. rel. Williams v. Peabody Coal Co., 822 F.2d 1134, 1151 (D.C. Cir. 1987) (dissent) ("I do not believe the panel intended or has made so sweeping a disposition").
Accordingly, the statute requires a PRO to inform a complainant of the PRO's final determination or decision about the quality of care provided to the beneficiary, which at the very least requires the PRO to tell the complainant whether it found a violation of the standard of care and, if it found a violation, the corrective action taken. Indeed, that is the very information that HCFA requires PROs to disclose to complainants when a practitioner has either consented to disclosure or is not identified in the final disposition. See PRO Manual § 5030(B) (R. 20); See Letter from R. Hojnicki, Health Care Excel, to D. Shipp, concerning Dr. Thurman, Aug. 7, 2000 (R. 9).
Outside the context of this litigation, defendants themselves acknowledge that the statute requires PROs to disclose the final dispositions of investigations, without regard to practitioner consent. Thus, in 1989, HCFA proposed a new regulation, 42 C.F.R. § 466.106, which would provide, in relevant part:
54 Fed. Reg. 1956, 1964 (1989).(2)
54 Fed. Reg. at 1960.
HCFA also proposed amending 42 C.F.R. § 476.133 (now codified at 42 C.F.R. § 480.133) -- the HCFA regulation that currently prohibits PROs from disclosing practitioner-specific information absent that practitioner's consent -- to provide:
54 Fed. Reg. at 1964.
Furthermore, in an addendum to the proposed regulations, HCFA submitted "model letters" for PROs to follow when notifying beneficiaries of the results of investigations. If a PRO's investigation were to determine that the quality of care did not meet professionally recognized standards of health care, HCFA proposed that the letter sent by the PRO to the complainant would state, in relevant part:
54 Fed. Reg. at 1967 (emphasis in original).
65 Fed. Reg. 73782, 73844 (2000).(3) As the proposed amendments and the agency commentary acknowledge, the plain language of section 1320c-3(a)(14) requires PROs to inform beneficiaries of the final disposition of PRO investigations into complaints, without exception.
For the foregoing reasons, HCFA's prohibition against disclosure of the final disposition of PRO investigations absent the involved practitioners consent violates 42 U.S.C. § 1320c-3(a)(14). Accordingly, this Court should grant plaintiff's motion for summary judgment, declare HCFA's regulations prohibiting disclosure of the final disposition of PRO investigations invalid, declare that the provisions in the PRO Manual directing nondisclosure invalid, and order HCFA to direct PROs to disclose the final disposition of every investigation to the complainants, regardless of whether the practitioners involved consent to disclosure.
DATED: March 8, 2001 Respectfully submitted,
Amanda Frost (D.C. Bar. No. 467425)
Counsel for Plaintiff
UNITED STATES DISTRICT COURT
PUBLIC CITIZEN, INC., ) Civil Action No. 00-0731 (ESH)
DEPARTMENT OF HEALTH )
AND HUMAN SERVICES )
HEALTH CARE FINANCING )
Upon consideration of plaintiff's motion for summary judgment, defendants' opposition thereto, and the entire record herein, it is this ___ day of __________, 2001,
ORDERED that plaintiff's motion for summary judgment is GRANTED. It is
FURTHER ORDERED that HCFA's regulations prohibiting disclosure of the results of PRO investigations are invalid because they are contrary to law. It is
FURTHER DECLARED that the provisions in HCFA's PRO Manual prohibiting disclosure of the results of investigations are contrary to law. It is
FURTHER ORDERED that within 10 days of the date of this Order, defendants will send a letter to PROs informing them that PROs are required to disclose the results of PRO investigations to complainants.
G. Michael Harvey
CERTIFICATE OF SERVICE
I, Amanda Frost, hereby certify that on this 8th day of March, 2001, I caused a copy of Plaintiff's Statement of Undisputed Material Facts to be mailed, first class, postage pre-paid to:
G. Michael Harvey
1. Only one other provision of the Act, 42 U.S.C. § 1320c-9(a), discusses disclosure of information by PROs. That section states, in relevant part:
Because this general prohibition against disclosure of information excepts information required to be disclosed by other provisions in the statute, it does not affect the disclosure requirement of § 1320c-3(a)(14).
2. HCFA has recodified its disclosure regulations, moving them from part 476 of the CFR to part 480 of the C.F.R. 64 Fed. Reg. 66234, 66279 (Nov. 29, 1999).
3. HCFA published a similar statement on April 24, 2000. 65 Fed. Reg. 22738, 22812-13 (2000).