oversight

Organ Procurement and Transplantation Network: Legal Liability and Data Confidentiality

Published by the Government Accountability Office on 1999-05-03.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

      United States

GAO   General Accounting Office
      Washington, D.C. 20548

      iXice   of the General      Counsel


      B-281728
      May 3,1999

      Congressional Requesters

      Subject: Organ Procurement and Transplantation Network: Legal Liability and Data                .
               Confidentiality

      The Organ Procurement and Transplantation Network (OPTN), the statutory program
      for procuring and allocating organs for transplant candidates, is operated under
      contract with the Department of Health and Human Services (HHS) by a private
      nonprofit entity, currently the United Network for Organ Sharing (UNOS). In
      legislation enacted last year, the Congress posed a series of questions concerning
      HHS’proposed modifications of the OPTN. As agreed with your staff, this letter
      responds to the two questions that involve legal determinations, specifically the
      impact of the modifications on (1) confidentiality of information about the program
      and (2) the possible legal liability of members of the Network arising from their “peer
      reviewn activities.’

      Medical advances have increased the number of patients who could benefit from an
      organ transplant, but the supply of organs has not kept pace with the demand. In
      1998, according to HHS, about 21,000 organs were transplanted, yet by the end of that
      year over 62,000 individuals were waiting for transplants.

      At present, the OPTN allocates organs largely on a local or regional basis. Transplant
      centers employ different criteria for determining who needs transplantation, and for
      determining the greatest medical need among transplant candidates.

      HHS believes the current system of regional allocation is inequitable in that organs do
      not necessarily go to the sickest patients. HHS sought comment in April of last year
      on a “final rule” that would have changed the allocation of organs by the OFTN to a
      national approach, with prioritization of transplant candidates to be based on
      standard medical criteria.’


      ’As provided in the law, the rest of the questions w-ill be addressed in a study
      conducted by the Institute of Medicine under contract with this Office.

      ’ Organ Procurement and Transplantation Network; Final Rule, 63 Fed. Reg. 16,296
      (1998) (to be codified at 42 C.F.R. pt. 121).



                                   GAOIOGC-99-47R   OPTN: Legal Liability   and Data Confidentiali~
                                                                                     . .   . .. .
                                                                                              ,..   .-


HHS’approach generated substantial concern; the current contractor and others
believe it would have an adverse effect on the program. In response, the Congress
enacted legislation postponing the effective date of the final rule from July 1998until
October 1999,and requiring this Office to contract with the Institute of Medicine for
a study of current OPTN policies and the proposed final rule.3 This report will be
completed no later than September 15, 1999.4

W e agreed with the cognizant congressional committees and the Institute of Medicine
that we would respond to the two legal questions posed by the law: the final rule’s
potential impact on (1) the liability under state peer review laws and procedures of
members of the OPTN and (2) the confidential status of information relating to the
transplantation of organs6

Both questions relate to the ability of the OPTN and its members to conduct what it
calls peer review-evaluations of the competence and performance of members and
potential members-without fear of public disclosure or legal liability. If the rule took
effect in its present form, it is feared, state laws immunizing peer reviewers from
lawsuits based on their evaluations and guaranteeing confidentiality of information
used in that process m ight be preempted by the federal requirements embodied in the
final rule, leaving reviewers vulnerable to suit and less willing to participate and be
candid in the peer review process.

W e conclude that the rule’s preemption provision is unlikely to affect the availability
of peer review liability protection Concerns about disclosure of information related
to the conduct of peer review are not unfounded, but are not solely the result of the
HHS rule. The risk of such disclosure exists nowin those states that do not provide
statutory immunity for peer reviewers or that define peer review in such a way that
their immunity provisions m ight not protect the peer review activities of theOPTN.
Where state law immunizes peer reviewers from suit, it would not be preempted by
HHS’rule, but the Secretary could preempt state laws that regulate disclosure of
information about peer review if she were to determine, as the rule provides, that
disclosure is in the public interest.


3See section 213(a) of the Department of Health and Human Services Appropriations
Act, 1999, 112 Stat. 2681359.
4The report will address the impact of the final rule on such issues as: accessto
transplantation services for low-income populations and for racial and ethnic
m inority groups; donation rates; waiting times; patient survival rates and organ failure
rates; and costs.
 ‘See subparagraphs 213(b)(l)(F) and (G) of the Department of Health and Human
 Services Appropriations Act, 1999,112 Stat. 2681359.



 Page 2                    GAOIOGC-99-47R    OP??N: Legal Liabilim   and Data Con6identiality
Whether or not state law in fact protects them, peer reviewers’ perception that their
deliberations might be disclosed or that they might be sued because of what they do
might affect their performance. For example, they may be less willing to express
opinions that reflect poorly on a participant’s professional performance if those
opinions might become public or if they, an institution with which they are affiliated,
or a colleague, might be sued.

 It was in part because of such concerns that existing federal law provides that peer
 review activities conducted under contract with HHS are generally immune from
 liability, and that information used for such peer review is protected from disclosure.
 However, it is not clear that this law applies to peer review as conducted by the
.0PTN.6

                  A more detailed discussion follows.

BACKGROUND

As advances in medical treatment during the 1970s and 1980s made increasing
numbers of organ transplants possible, the private sector, with encouragement from
federal and state governments, undertook efforts to promote organ donation and
organ transplantation and to coordinate these activities on a regional and national
level.7 However, it became apparent that organ donation and procurement procedures
were unable to meet the demand and to answer questions about the equity of
allocation.’

The Congress responded by enacting the National Organ Transplantation Act of 1984
(NOTA). NOTA requires the Secretary of HHS to contract with a private entity to
establish and operate the OPTN.’The responsibilities of the OFTN include:
maintaining lists of individuals requiring organs, facilitating matching of donors with
recipients, assisting in the equitable distribution of organs among transplant patients,
and adopting quality standards for acquiring and transporting donated organs!’

6Authority to determine whether the law in question is applicable to UNOS or to the
OPTN’s peer review process lies with HHS Chevron U.S.A. Inc. v. Natural Resources
Defense Council, 467 U.S. 837,843-845 (1984). HI-IS has not decided this question, and
UNOS seems to assume that the law does not protect it.

7See S. Rep. No. 98-382, at 1415 (1984), reprinted in 1984 U.S.C.C.A.N. 3975,3979-81.
’ See id. at 4.

’42 U.S.C. 3 274(a).
lo42 U.S.C. 0 274(b).



Page 3                        GAO(OGC-99-47R   OPTNt Legal Liability   and Data Confidentiality
                                                                                                           .;
                                                                                            :.
                                                                                                 7       ‘,.
                                                                                                                i’
                                                                                                     : ..,‘.
                                                                                                                .



UNOS has been the OPTN contractor since the inception of the Network in 1986.”
UNOS was one of the pioneers in organ transplant research and allocation; in fact,
before enactm ent of NOTA and its subsequent contractual responsibility for the
OPTN, UNOS had already established a national com puter system for patients
requiring a kidney transplant.‘*

UNOS organized the OPTN into eleven geographic regions. OPTN m embers now
include: 53 organ procurem ent organizations (OPOs) l3that, each within a
geographically defined service area, coordinate the identification of potential donors,
requests for donation, and the recovery and transport of organs14;272 centers where
organ transplants are perform ed, and 56 independent tissue-typing laboratories.

Under the current OPTN system , organ allocation is weighted toward the local use of
organs. When a donor dies, the hospital notifies its designated OPO. The OPO then
consults its waiting list in search of a local recipient within its service area If no
suitable recipient is found, the OPO either checks the list for the geographical region
in which the OPO is located, or notifies UNOS-which performs the sam e search. If
no suitable recipient is located within the OPO’s region, UNOS performs a nationwide
search, and selects the m ost m edically urgent candidate as a recipient.15

HHS and others have expressed concern that under this approach, organs m ay not
always be allocated to the m ost critically ill patients or to those whose needs are
m ost m edically urgent. For exam ple, the designated recipient in the donor’s
immediate OPO local area or region m ay not be as critically ill as a candidate in a
distant state. As a result, HHS believes, the chances of the sickest patients being
m atched to suitable organs are not m axim ized.16HHS has concluded that an organ

I1No other contractor has ever com peted for this contract.
‘* &     S. Rep. No. 98-382, at 3.
I3There are 62 OPOs in the OPTN, however, 9 of these OPOs are hospital-based, and
therefore do not have independent m emberships.
l4For exam ple, the Louisiana OPO performs all organ transplant coordination in the
state of Louisiana. However, m any of the OPOs are regional, rather than coextensive
with a state like the Louisiana organization.
l5Allocation of thoracic organs-hearts and/or lungs-is subject to som ewhat
different rules. If the organ cannot be utilized locally, it is then offered in increasing
concentric circles based on distance from the donor hospital. See UNOS Policy 3.7, at
http://www.unos.org.
I6See 63 Fed. Reg. at 16,298.



Page 4                        GAOIOGC-99-47R   OFTN: Legal Liability   and Data Confidentiality
allocation system that functions equitably on a nationwide basis would best serve
transplant patients.”

On April 2,1998, the Secretary of HHS invited public comment on a rule, to be
effective 3 months later, to eliminate the OPTN’s current local-first organ allocation
policy. The rule requires the OPTN to establish an organ allocation system that
functions, to the extent feasible, on a national basis, allocating organs based on the
urgency of patients.’medical status rather than on geographic location.

Under the new rule, the OPTN would establish: (1) standardized minimum criteria for
including transplant candidates on a national waiting list; (2) “objective medical
criteria to be used nationwide” for ranking patients on the waiting list into status
groups, from the most to least medically urgent; and (3) donor allocation policies that
give priority to patients with the highest medical urgency, with a patient’s waiting
time in a particular status group used to break ties within those groups.” The new
rule also requires the OPTN to submit its proposed allocation criteria and policies to
the Secretary for evaluation and possible public comment.‘g

In addition, the rule contains a new data release requirement. It provides that HHS
may release any collected organ transplant program data that “the Secretary
determines wiIl provide information to patients, their families, and their physicians
that will assist them in making decisions regarding transplantation.“20

Finally, the rule contains a “preemption” provision to deal with situations in which
state or local governments have requirements that conflict with those of the rule:

         No State or local governing entity shall establish or continue in effect
         any law, rule, regulation, or other requirement that would restrict in any
         way the ability of any transplant hospital, [organ procurement
         organization], or other party to comply with organ allocation policies of
         the OPTN or other policies of the OITN that have been approved by the
         Secretary under this Part.”

li See 63 Fed. Reg. at 16,299.For a discussion of this debate, see Gail L. Dauber&
Comment, Politics, Policies, and Problems with Organ Transplantation: Government
Regulation Needed to Ration Organs Equitably, 50 Administrative L. Rev. 459 (Spring
1998).
IsSee 63 Fed. Reg. at 16,296.
lgSee 63 Fed. Reg. 16,334(to be codified at 42 C.F.R. 5 121.4(b)(2)).
”&       63 Fed. Reg. 16,338(to be codified at 42 C.F.R. $ 121.11(c)).
*l See 63 Fed. Reg. 16,338(to be codified at 42 C.F.R. Q 121.12).



Page 5                       GAO/OGC-99-47R   OPTN: Legal Liability   and Data Confidentiality
The proposed new rule has been criticized on several grounds. Of relevance to this
discussion, UNOS is concerned that the final rule, by preempting state law, strips
OPTN members of liability protections under state statutes, subjecting them to
potential lawsuits arising out of their service on UNOS’peer review committees. In
addition, UNOS believes that the final rule dismantles traditional mechanisms for
safeguarding confidential peer review information and the processes under which it is
collected, and that the result of disclosure of such information would be to facilitate
lawsuits either by the subjects of critical reviews against peer reviewers, or by
patients against providers who were criticized by peer reviewers.

STATE PEER REVIEW LIABILITY PROTECTIONS

In general, peer review means the evaluation of a professional by other professionals
in the same field.” In medicine, the term “peer review” generally refers to the review,
by a group or committee of physicians, of practices and procedures of fellow
physicians, in an attempt to monitor or discover those whose skills fa3l below the
required standards or who pose a danger to the health of patientsz3 For example,
most hospitals have a peer review committee that evaluates whether a particular
physician should be given practicing privileges, or alternatively, whether a particular
medical procedure was conducted properly.

UNOS characterizes several of its activities as “peer review undertaken by UNOS as
the OPTN.“24These activities are in addition to any peer review conducted by
individual OPTN member entities, such as a peer review committee within a
transplant center or’tissue-@ping laboratory.

According to UNOS, any entity applying for membership in the OPTN is subject to a
formal review process by UNOS’Membership and Professional Standards Committee
(the Committee), which comprises physicians and OPO representatives selected from
each of the OPTN’s 11 geographic regionsz5 If, for example, a hospital wishes to be


z See Barbara K. Miller, Defending the System: Application of the htraenterprise
Immunity Doctrine in Physician Peer Review Antitrust Cases, 75 Tex. L. Rev. 409
(1996).
23&      121 A.L.R. Fed. 255 (1998).
” Letter from Cindy M. Sommers, Assistant Director for Policy Development, UNOS,
to Behn Miller, Offke of the General Counsel, GAO (April 8,1999). See also UNOS’
bylaws and policy set out at httn://www.unos.org.
25The current Committee comprises 17 physicians and 3 OPO representatives.



Page 6                       GAOIOGC-9947R   OPTNz Legal Liability   and Data Confidentiality
added to the OPTN as a transplant center, the Committee will review the facility and
its physicians.

The Committee also conducts what TJNOScharacterizes as peer review of each OPTN
member’s performance and compliance with OPTN policy. For example, an OPTN
member that cannot demonstrate compliance with UNOS’ organ allocation policies
may be asked to explain its actions to the Committee. If deviations are found, the
Committee will endeavor to bring the OPTN member into compliance.

Additionally, if the survival rate of transplant patients at an individual transplant
center drops below the established OPTN performance goa for a specific organ, the
Committee will engage in “peer review” to identify the basis for the low survival rate,
and will audit the physicians or programs to discover the reason for the low
performance and determine how to resolve the deficiency. UNOS reports that its audit
teams typically include a physician or surgeon involved in transplantation of the
particular organ, and an individual with experience as a transplant hospital
administrator or clinical transplant coordinator.

The OPTN also uses regional review boards to assess “urgent status” patient listings
for liver and heart allocation. Each of the 11 OPTN regions has a separate review
board for each organ, comprising health care professionals and public representatives
from that region.

UNOS explains that the effectiveness of the Committee and the regional review
boards depends on the willingness of OPEN members to participate openly and fully
and to share patient-identifiable and institution-specific information. This openness,
UNOS says, is facilitated through the combination of state laws protecting peer
review activities from lawsuits and of policies prohibiting the disclosure of
information about the deliberations and conclusions of the reviewers.

Currently, 49 states’”grant some form of immunity to members of medical peer
review committees or organizations.2iWhile most state statutes insulate only medical

” Virginia has not enacted medical peer review liability protections.
” A federal statute-the Health Care Quality Improvement Act of 1986 (HCQLA), 42
U.S.C. 5 11101et seq.-also extends immunity for some peer review activities. Under
that law, “professional review actions” taken by a “professional review body” and
meeting certain standards are insulated from damage actions under federal and state
law. For a discussion of the HCQIA, see Lu Ann Trevina, Note, The Health Care
Quality Improvement Act: Sword or Shield?, 22 Thur. Mar. L. Rev. 315 (1997) and Gail
N. Friend, Jennifer Rangel, Madison Finch, Brent A. Storm, The New Rules of Show
and Tell: Identifying and Protecting the Peer Review and Medical Committee
Privileges, 49 Baylor L. Rev. 607 (1997).




Page 7                    GAO/OGC-99-47R   OPTN: Legal Liability   and Data Confidentiality
professionals from peer review liability,28 the peer review liability laws of some states
protect all members conducting peer reviews, including non-physicians, from
potentisil plaintiffs.B For example, Louisiana’s statute provides:

      No member of any such [peer review] committee . . . or any sponsoring
      entity, organization, or association on whose behalf the committee is
      conducting its review shall be liable in damages to any person for any
      action taken or recommendation made within the scope of the
      functions of such committee if such committee member acts without
      malice and in the reasonable belief that such action or recommendation
      is warranted by the facts known to hin~.~’

UNOS is concerned that the rule promulgated by HHS will preempt state peer review
liability protections, and as a result impair the OPTN peer review process. If OPTN
members were subject to liability under state law, they might be unwilling to
participate in peer review. UNOS believes that even if willing to serve on the peer
review committees, an OPTN member might, without the state liability protections,
be more likely to approve an application or a patient’s medical status determination
in order to avoid the possibility of a lawsuit.




B In such states-e.g., Connecticut (which only exempts “health care providers” from
peer review liability, see CONN.GEN. STAT.0 19a-17b(West 1997)) or Colorado (which
only extends immunity to physician peer review committees, see COLO.REV.STAT.0
12-36.5-103(1998))-UNOS and the established OPTN peer review committees do not
appear to qualify for peer review immunity because of the narrow scope of coverage.
B For example, in Oklahoma, “not-for-profit corporations” are extended “immunity
from civil liability,” see 76 OKLA. STAT.tit. 63,s 31(1998); in Washington, peer review
immunity is granted to “an entity” that employs at least one Washington-state licensed
medical professional, see WASH.REV. CODE0 7.70.020(1999)). In states with such
broad protections, UNOS and the established OFTN peer review committees appear
to qualify for immunity.
” LA. REV. STAT.ANN. 6 13:3715.3.C(West 1998). Louisiana’s peer review statute
applies to a wide range of health care providers, hospitals, and professional
organizations and associations. Other states provide even broader protection. For
example, Hawaii’s law, unlike Louisiana’s, does not specify that immunity is only
available if the reviewers’ actions are reasonably based on known facts and not
motivated by malice. See HAW. REV. STAT.$624-25.5 (1998).




Page 8                      GAOIOGC-99-47R    OPTN: Legal Liability   and Data Confidentiality
We conclude that the preemption provision in the final rule is unlikely to affect the
availability of state medical peer review liability protection.31GeneraUy,preemption
takes place only to the extent that a confiict arises between the state and federal
provisions. We see no apparent confIict between the final ruIe and the state laws
governing peer review.32

The possibility of conflict and preemption does exist with respect to laws in those
states-among them Arkansas, Florida, Louisiana, Mississippi, Oklahoma, South
Carolina and Tennessee%    -that give preference in organ allocation to state residents%
whenever a state resident is not the next designee on the national Iist.35As a result of
federal preemption, the OPTN wilI be required to allocate the organ to the out-of-state
recipient. However, none of these states links peer review liability protection to
adherence with local allocation of organs. Federal preemption should not reach
these states’peer review liability protections recognizing, however, that no one can
say with certainty what the ultimate outcome of litigation on this issue might be, or

311tis weli established that federal regulations have no less preemptive effect than
federal statutes over state law. & Canital Cities Cable Inc. v. Crisn, 467 U.S. 691,699
(1984); F’idelitv Fed’1Sav. & Loan v. De La Cues@ 458 U.S. 141,154 (1982).
““[SItate law is nuhified to the extent that it actually conflicts with the federal law.
Such a conflict arises when ‘compliance with both federal and state regulations is a
physical impossibility,’ [citation omitted] or when state law ‘stands as an obstacle to
the accomplishment and execution of the full purposes and objectives of Congress’
[citation omitted].” FideIitv Federal Savings & Loan Ass’n v. De La Cue&a, 458 U.S.
141,153 (1982).
33See ARK. CODEANN. $20-17-617 (Michie 1997); F’LA.STAT.ch. 732.922 (1998); LA.
REV. STAT.ANN. 6 17~2353(West 1998); MISS.CODEANN. 0 41-39-15 (1998); OKL~
STAT.tit. 63,s 2204 (1998); S.C. CODEANN. 0 44-43-410(Law. CO-OP. 1998); S.B. 311,
101”G.A. (Tenn. 1999).
M We understand that the states of Arizona, Missouri, and Nevada have proposed
similar local-preference organ allocation policies for enactment. See H.B. 2269, 44th * _
Leg., 1” Reg. Sess.(Ariz. 1999); H.B. 612,90* G.A., 1”Reg. Sess. (MO. 1999); Cont. Res.
19, 70thReg. Sess. (Nev. 1999). In addition, the states of Kansas and New Jersey have
proposed state resolutions urging the United States Congress and the Secretary of
HHS to reconsider the new rule’s national organ allocation goal because of alleged
concerns that the rule will adversely affect potential recipients in those states. See
H.C.R. 5013, 78thLeg., 1999 Reg. Sess. (Ran. 1999); S.R. 39, 208’hLeg., (N-J. 1998).
3’The Arkansas statute giving preference to Arkansas patients for all organs and
tissues procured in Arkansas probably would not have to be preempted by the federal
rule since, by its own terms, it does not apply if it “would be in confiict with federally
mandated guidelines.” ARK. CODEANN. 9 20-17-617(Michie 1997).



Page 9                     GAOIOGC-99-47R   OPTN: Legal Liability   and Data Confidentiality
whether all courts would reach the same conclusion. As discussed below, the
behavior of peer reviewers may be influenced by the possibility of preemption
removing their protection from liability, however unlikely it may be that such
preemption will occur.

CONFiDENTIALIT       OF INFORMATION

The concern of UNOS and others about potential liability of OPTN members as a
result of their participation in peer review is exacerbated by the treatment of
confidentiality in the HHS rule. The rule gives the Secretary broad authority to
disclose information about the OPTN:

       The Secretary may release to the public information collected under
       this section when the Secretary determines that the public interest will
       be served by such release. The information which may be released
       includes, but is not limited to, information on the comparative costs and
       patient outcomes at each transplant program affiliated with the OPTN,
       transplant program personnel, information regarding instances in which
       transplant programs refuse offers of organs to their patients,
       information regarding characteristics of individual transplant programs,
       information regarding waiting time at individual programs, and such
       other data as the Secretary determines will provide information to
       patients, their families, and their physicians that wi.U assist them in
       making decisions regarding transplantation . . . .= (Emphasis added.)

In responding to concerns expressed by some of those commenting on a draft of the
rule, HEIS acknowledged that protection of confidentiality is important but also
pointed out that data collected by the OPTN, a federal contractor using public funds,
“generally should be in the public domain.” HHS cites the need of bona fide
researchers to have access subject to appropriate protections against redisclosure-
to detailed data, including personally identifiable medical records, in evaluating how
to improve organ transplantation and allocation.X



3663 Fed. Reg. 16,338(to be codified at 42 C.F.R. 5 121.11(c)).
37Some are concerned that another pending federal initiative might have an impact on
these aspects of the OPTN’s operations. The Office of Management and Budget
(OMB) recently sought public comment on a proposed revision to its Circular A-l 10,
see 64 Fed. Reg. 5,684 (1999). The revision would require federal agencies to make
available to the public any federally-funded research or data underlying published
research findings used by the government to develop policy or rules (unless the data
are exempted from release by other law).



 Page 10                   GAO/OGC-99-47R    OPTN: Legal Liability   and Data Confidentiality
UNOS’chief objection to the fInal rule’s data release provision is again related to
what it perceives as the potential for an adverse effect on the peer review process.
Most states,3sas part of the peer review protection statutes discussed above, have
created a privilege for peer review which precludes the disclosure of committee
proceedings and records--and, in some cases, the identities of the committee
members-to the public.

UNOS is concerned that, relying on her authority in the final rule to disclose data that
she determines “will provide information to’patients, their families, and their
physicians that will assist them in making decisions regarding transplantation,” the
Secretary could, notwithstanding the state protections, disclose the identities of peer
review committee members, records of their meetings, or other information about the
peer review process. The availability of that kind of information, it is feared, could
make it easier for patients or providers to sue the OFTN peer review committee
members. According to UNOS, without the state safeguards that promote candid
participation by committee members, the OFTN and its members will be hesitant to
participate in the OPEN peer review process or to express candid and objective
opinions.

To the extent that the information concerned is proprietary or involves trade secrets
of UNOS or anyone else, the Secretary would be prohibited by law from disclosing it,
but it is not clear that this prohibition would protect all information concerning OPTN
peer review. Under 18 U.S.C. 0 1905, the Secretary-and any officer or employee of
the United States-is expressly prohibited from disclosing, to any extent not
authorized by law, information which “concerns or relates to the trade secrets,
processes, operations, style of work, or apparatus, or to the identity, confidential
statistical data, amount or source of any income, profits, losses or expenditures of
any person, firm, partnership, corporation or association.” However, we cannot say
that all information about peer review would be considered proprietary.

Thus, with the exception of proprietary information, the Secretary has authority to
disclose peer review committee data that would be protected under state statutes, if
she decides that the public interest in disclosure outweighs the interest in
confidentiality. HHS points out that in creating this authority it was trying to strike a


” For a discussion of the peer review committee privilege, see Charles David Creech,
Comment, The MedicaI Review Committee Privilege: A Jur&&ctional Survey, 67
North Carolina L. Rev. 179 (November 1998). Typically, state peer review committee
protections are quite broad; for example, the state of Alabama’s peer review
protection, see ALA. CODE 8 6-5-333(1999), provides that “[alll information,
interviews, reports, statements, or memoranda. . . are privileged [and] “[t]he records
and proceedings of any such committees shall be confidential . . . and shall not be
public records nor be available for court subpoena or for discovery proceedings.”



Page 11                    GAO/OGC-99-47R    OPTN: Legal Liability   and Data Confidentiality
balance between the interest in confidentiality and its statutory duty to provide
information about transplantation, specifically about the resources available
nationally and in each State, and the comparative costs and patient outcomes at each
transplant center affiliated with the organ procurement and transplantation network.3g
HHS also observes that the disclosure requirement is not a radical departure from
prior practice; it has in the past required UNOS to include extensive data in its
published reports, such as hospital-specific survival daia4’

However, (apart from trade secret information which is expressly protected by
federal law as described above), it is true that the Secretary could decide to disclose
peer review information, and that her decision to do so would preempt state
prohibitions against such disclosure. In deciding whether the public interest
outweighs the interest in confidentiality, the Secretary would certainly have to
consider the impact on peer review of disclosure. We cannot judge the likelihood that
she would do so, but the possibility does exist.

UNOS believes that preemption of state confidentiality statutes and regulations,
coupled with disclosures by HHS of what institutions regard as confidential business
information or specific data or minutes from meetings of the Committee or the
regional review boards, will result in a marked increase in litigation against UNOS
and OPTN members and may make it difficult to persuade individuals to serve on the
Committee and regional review boards. In those states with broadly worded statutes
that provide liability protections for peer review committee members, the effect of
preemption should be minimal. We agree with UNOS, however, that there could be a
heightened risk of litigation in states lacking peer review statutes under which OPTN
members serving on UNOS’review boards might qualify for immunity from liability.4’
Moreover, even where state immunity protects peer reviewers from legal liability, the
prospect that their deliberations might be disclosed could detract from their
willingness to participate with candor and objectivity.




39See 63 Fed. Reg. 16,320.
JOSee 42 USC. 0 274~. The purpose of this disclosure is to assist patients, their
families, and their physicians “with the costs associated with transplantation.” That
suggests that disclosure of peer review information may not be required, unless it can
be shown to relate in some way to this purpose.
” It is not clear that a federal statute which extends immunity for some peer review
activities applies to OPTN members serving UNOS’review boards. See also sunra
notes 5 and 27.



Page 12                    GAO/OGC-99-47R   OPTNz Legal Liability   and Data Confidentiality
CONCLUSION

HHS’final rule does not preempt the many state laws that protect peer reviewers
from liability arising from the conduct of the peer review. The rule preempts state
laws only to the extent it is inconsistent with those laws. State protections against
liability for peer review do not appear to be inconsistent with the final rule. However,
some states may not provide such protection for the OPTN.

State laws prohibitig disclosure of peer review data could be preempted by the final
rule. The’Secretary of HHS has authority under the final rule to decide that the public      *
interest in disclosure of information about organ transpiants outweighs the interest in      i
confidentiality. It is possible that she would do so with respect to peer review
information.

In those states whose laws do not immunize the OPTN peer reviewers, the disclosure
of information about peer review activities could make it easier for potential plaintiffs
to gather information that would be helpful in a lawsuit. Even in the states that
protect them from liability, however, the possibility of disclosure could have some
undesirable effects: reviewers might be less candid if they were concerned that their
deliberations and opinions about colleagues could become public, and might become
the basis for suits against those colleagues.

If you or your staffs have any questions about the information in this letter, please call
me at (202) 5125400 or Barry R. Bedrick, Associate General Counsel, at (202) 512-
8203. Other contributors to this letter were Behn Miller and Dayna Shah.

Sincerely yours,



Robert P. Murphy
General Counsel




Page 13                   GAOYOGC-99-47R OPTN: Legal Liability   and Data Confidentiality
The Honorable Arlen Specter
Chairman
The Honorable Tom Harkin
Ranking Minority Member
Subcommittee on Labor, Health and Human Services,
 and Education, and Related Agencies
Committee on Appropriations
United States Senate

The Honorable James M. Jeffords
Chairman
The Honorable Edward M. Kennedy
Ranking Minority member
Committee on Health, Education, Labor, and Pensions
United States Senate

The Honorable John Edward Porter
Chairman
The Honorable David R. Obey
Ranking Minority Member
Subcommittee on Labor, Health and Human Services,
 Education, and Related Agencies
Committee on Appropriations
House of Representatives

The Honorable Tom Bhley
Chairman
The Honorable John D. Dingell
Ranking Minority Member
Committee on Commerce
House of Representatives




 Page 14                 GAOiOGC-99-47R   OPTN: Legal Liability   and Data Confidentiality
Ordering      Information

The first copy of each GAO report and testimony is free.
Additional   copies are $2 each. Orders should be sent to the
following  address, accompanied by a check or money order
made out to the Superintendent     of Documents, when
necessary. VISA and Mastercard      credit cards are accepted, also.
Orders for 100 or more copies to be mailed to a single address
are discounted 25 percent.

Orders      by mail:

U.S. General Accounting     Office
P.O. Box 37050
Washington, DC 20013

or visit:

Room 1100
700 4th St. NW (corner of 4th and G Sts. NW)
U.S. General Accounting Office
Washington, DC

Orders may also be placed by calling (202) 512-6000
or by using fax number (202) 512-6061, or TDD (202) 512-2537.

Each day, GAO issues a list of newly available reports and
testimony.   To receive facsimile copies of the daily list or any
list from the past 30 days, please call (202) 512-6000 using a
touchtone phone. A recorded menu will provide information         on
how to obtain these lists.

For information on how to access GAO reports on the INTERNET,
send an e-mail message with “info” in the body to:

info@www.gao.gov
                                                                       .
or visit    GAO’s World Wide Web Home Page at:

httpz/Ywww.gao.gov
United States                              Bulk Rate
General Accounting    Office         Postage & Fees Paid
Washington,   D.C. 20548-0001                 GAO
                                       Permit No. GlOO
Official   Business
Penalty    for Private   Use $300
Address    Correction    Requested