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 (EDH)
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MEMORANDUM IN SUPPORT OF
PLAINTIFF'S MOTION FOR SUMMARY JUDGMENT

                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:

The [peer review] organization shall conduct an appropriate review of all written complaints about the quality of services (for which payment may otherwise be made under subchapter XVIII of this chapter) 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 (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).

                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:

[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). 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:

We have carefully examined your concern(s) and conducted a thorough review of the medical records pertaining to the services that (you or name of beneficiary) received. Federal regulations prohibit us from releasing information that identifies the involved practitioner without his or her consent. Because the involved practitioner did not give (his or her) consent, we are unable to release information that would explicitly or implicitly identify him/her. This does not necessarily mean that we found a problem with the services (you or name of beneficiary) received. However, we will take appropriate action if warranted by our review findings.

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.

B. Factual Background

                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:

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 [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. 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. 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.

ARGUMENT

                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
Disclosure Of The Final Dispositions Of Investigations Without An
Identified Practitioners Consent Violate The Peer Review Improvement Act

                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:

In accordance with section 1154(a)(14) of the Act [42 U.S.C. § 1320c-3(a)(14)], for beneficiary complaints about the quality of services, the PRO must conduct a review of the complaint as required under § 466.70(a)(2) and

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(b) In accordance with § 476.132(a) and (c) of this chapter, inform the beneficiary or the beneficiary's representative whether the quality of care meets professionally recognized standards of health care, and, if not, the corrective action to be taken.

54 Fed. Reg. 1956, 1964 (1989).(2)

In its regulatory commentary accompanying the proposal, HCFA explained:

                   We would require that, in conducting an appropriate review of a beneficiary's complaint, the PRO [i]nform the beneficiary or the beneficiary's representatives whether or not the quality of care meets professionally recognized standards of health care, and the corrective action taken if necessary (that is denial of payment, education, intensified review, or sanctions);

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                   We note that the nature of the complaint may be so unique or the service in question so specific that implicit identification of an individual concerned could be an unavoidable consequence of compliance with section 1154(a)(14) of the Act [42 U.S.C. § 1320c-3(a)(14)].

                   We considered precluding PROs from providing any information to the beneficiary that might identify the concerned physician or practitioner. However, we believe that section 1154(a)(14) of the Act requires that the information discussed above be provided to the beneficiary, which, in some cases, may have that unintended effect.

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:

(b)(4) The PRO, in response to a beneficiary complaint (as described in § 466.106 of this chapter) that is so unique or the service in question so specific, may identify the individual practitioner or other practitioner, without their consent, as an unavoidable consequence of responding to the complaint.

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:

We have reviewed your case and have found that the quality of services you received does not meet professionally recognized standards of health care.  We have taken the following steps to correct this situation: (list specific correction actions taken -- education, intensified review, sanctions).

54 Fed. Reg. at 1967 (emphasis in original).

                Although HCFA has yet to issue a final rule, it has never abandoned the proposal. In fact, on November 30, 2000 -- eight months after this case was filed and nearly three months after plaintiffs filed their first motion for summary judgment -- HCFA confirmed that its proposed amendments are still pending and reiterated its conclusion that 42 U.S.C. § 1320c-3(a)(14) requires disclosure of the final dispositions of investigations of complaints. HCFA's November statement, published in its Unified Agenda of Federal Regulatory and Deregulatory Actions, explained:

This rule would change our policy regarding the disclosure of peer review organization ("PRO") information in responding to beneficiary complaints about physicians, other practitioners, and other institutional and non-institutional providers of health care, including Health Maintenance Organizations and Competitive Medical Plans. Under the proposal, we would permit the disclosure of PRO information about physicians and other individual practitioners without their permission to the extent necessary to comply with section 1154(a)(14) of the Social Security Act [42 U.S.C. § 1320c-3(a)(14)]. This section requires PROs to conduct reviews of beneficiary complaints about the quality of services that do not meet professionally recognized standards of care and inform each beneficiary of the final disposition of his or her complaint.

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.

                Despite the statutory requirement that PROs disclose the "final disposition" of their investigations to the complainants, HCFA's regulations and Manual prohibit PROs from making such disclosures absent the consent of an identified practitioner. See, supra, pp. 3-5. As a result of HCFA's policy, PROs refuse to provide complainants such as David Shipp the final disposition of their investigations. See Letters from R. Hojnicki, Health Care Excel, to D. Shipp (R. 5, 7). As HCFA itself acknowledged in its proposed amendments to its regulations, its current regulations are at odds with the Peer Review Improvement Act's disclosure requirement. Because the Act requires that every complainant be informed of the final disposition of a PRO investigation into his or her complaint and makes no exception for cases in which a practitioner does not consent to disclosure, HCFA's regulations and the provisions of the PRO Manual prohibiting disclosure are contrary to law.

CONCLUSION

                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)
Allison M. Zieve (D.C. Bar. No. 424786)
PUBLIC CITIZEN LITIGATION GROUP
1600 20th Street, NW
Washington, DC 20009
(202) 588-1000

Counsel for Plaintiff

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

PUBLIC CITIZEN, INC., ) Civil Action No. 00-0731 (ESH)

)

Plaintiff, )

)

v. )

)

DEPARTMENT OF HEALTH )

AND HUMAN SERVICES )

)

and )

)

HEALTH CARE FINANCING )

ADMINISTRATION, )

)

Defendants. )

______________________________)

ORDER

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.

______________________________

ELLEN HUVELLE
UNITED STATES DISTRICT JUDGE

Copies to:

Amanda Frost
Public Citizen Litigation Group
1600 20th Street, NW
Washington, DC 20009

G. Michael Harvey
U.S. Attorney's Office
Judiciary Center Building
555 Fourth Street, NW
Washington, DC 20001

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
Assistant United States Attorney
Judiciary Center Building
555 4th Street, N.W.
Washington, D.C. 20001


_________________________

Amanda Frost

 

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:

Any data or information acquired by any such [PRO] 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 that may be 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 . . . .

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).