I
103D CONGRESS
2D SESSION
H. R. 3486
To establish safe harbors from the application of the antitrust laws for
certain activities of providers of health care services, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
NOVEMBER 10, 1993
Mr. ARCHER introduced the following bill; which was referred to the
Committee on the Judiciary
MAY 12, 1994
Additional sponsors: Mr. CALLAHAN, Mr. BARCIA of Michigan, Mr. GOSS, Mr.
PARKER, Mr. PETRI, Mrs. FOWLER, Mr. CANADY, Mr. DUNCAN, Mr.
DORNAN, Mr. DICKEY, Mr. SUNDQUIST, Mr. DERRICK, Mr. ALLARD, Mr.
KLUG, Mr. GORDON, Mr. BONILLA, Mr. ZELIFF, Mr. INHOFE, Mr.
DELAY, Mr. GOODLING, Mrs. LLOYD, Mr. HUTCHINSON, Mr. CRAPO, Mr.
MANZULLO, Mr. TAYLOR of North Carolina, Mrs. UNSOELD, Mr. BREW-
STER, Mr. FRANKS of Connecticut, Mr. FIELDS of Texas, Mr. SWETT,
Mr. NUSSLE, Mr. THOMAS of Wyoming, Mr. UPTON, Mr. BOEHNER, Mr.
SENSENBRENNER, Mr. RAVENEL, Mr. COMBEST, Mr. CRAMER, Mr.
CLEMENT, Mr. LEVY, Mrs. VUCANOVICH, Mr. HALL of Ohio, Mr. MONT-
GOMERY, Ms. PRYCE of Ohio, Mr. KNOLLENBERG, Mr. PETE GEREN of
Texas, Mr. YOUNG of Alaska, Mr. HOEKSTRA, Mr. SMITH of Oregon, Mr.
RAMSTAD, Mr. INSLEE, Mr. STUMP, Mr. MCDADE, Mr. PAXON, Mr.
PORTMAN, Mr. SMITH of New Jersey, Mr. MCHUGH, Mr. BUNNING, Mr.
BACHUS of Alabama, Mr. HOBSON, Mr. COBLE, Mrs. BYRNE, Mr. ROG-
ERS, Mrs. JOHNSON of Connecticut, Mr. MOORHEAD, Mr. EWING, Mr.
HANCOCK, Mr. INGLIS of South Carolina, Mr. SANGMEISTER, Mr. SHAYS,
Mr. MCCANDLESS, Mr. LIGHTFOOT, Mr. JEFFERSON, Mr. LAZIO, Mr.
KYL, Mr. EHLERS, Mr. BLILEY, Mr. OXLEY, Mr. MACHTLEY, Mr. SOLO-
MON, Mr. ARMEY, Mr. GOODLATTE, Mr. PACKARD, Mr. ZIMMER, Mr. PE-
TERSON of Minnesota, Mr. DEFAZIO, Ms. MCKINNEY, Mr. ROTH, Mr.
HANSEN, Mr. BARCA of Wisconsin, Mr. DEUTSCH, Mr. MICA, Mr. CAS-
TLE, Ms. DUNN, Mr. MCINNIS, Mr. JOHNSON of South Dakota, Mr.
HUTTO, Mr. ROWLAND, Mr. STEARNS, Mr. PAYNE of Virginia, Mr. COL-
LINS of Georgia, and Mr. TAUZIN
A BILL
To establish safe harbors from the application of the anti-
trust laws for certain activities of providers of health
care services, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Health Care Antitrust
Improvements Act of 1993’’.
SEC. 2. EXEMPTION FROM ANTITRUST LAWS FOR CERTAIN
COMPETITIVE AND COLLABORATIVE ACTIVI-
TIES.
(a) EXEMPTION DESCRIBED.—An activity relating to
the provision of health care services shall be exempt from
the antitrust laws if—
(1) the activity is within one of the categories
of safe harbors described in section 3;
(2) the activity is within an additional safe har-
bor designated by the Attorney General under sec-
tion 4; or
(3) the activity is specified in and in compliance
with the terms of a certificate of review issued by
the Attorney General under section 5 and the activ-
ity occurs—
(A) while the certificate is in effect, or
(B) in the case of a certificate issued dur-
ing the 2-year period beginning on the date of
the enactment of this Act, at any time on or
after the first day of the 2-year period that
ends on the date the certificate takes effect.
(b) AWARD OF ATTORNEY’S FEES AND COSTS OF
SUIT.—
(1) IN GENERAL.—If any person brings an ac-
tion alleging a claim under the antitrust laws and
the activity on which the claim is based is found by
the court to be exempt from such laws under sub-
section (a), the court shall, at the conclusion of the
action—
(A) award to a substantially prevailing
claimant the cost of suit attributable to such
claim, including a reasonable attorney’s fee, or
(B) award to a substantially prevailing
party defending against such claim the cost of
such suit attributable to such claim, including
reasonable attorney’s fee, if the claim, or the
claimant’s conduct during litigation of the
claim, was frivolous, unreasonable, without
foundation, or in bad faith.
(2) OFFSET
IN
CASES
OF
BAD
FAITH.—The
court may reduce an award made pursuant to para-
graph (1) in whole or in part by an award in favor
of another party for any part of the cost of suit (in-
cluding a reasonable attorney’s fee) attributable to
conduct during the litigation by any prevailing party
that the court finds to be frivolous, unreasonable,
without foundation, or in bad faith.
SEC. 3. SAFE HARBORS.
The following activities are safe harbors for purposes
of section 2(a)(1):
(1) COMBINATIONS
WITH
MARKET
SHARE
BELOW
THRESHOLD.—Activities relating to health
care services of any combination of health care pro-
viders if the number of each type or specialty of pro-
vider in question does not exceed 25 percent of the
total number of such type or specialty of provider in
the relevant market area.
(2) ACTIVITIES OF MEDICAL SELF-REGULATORY
ENTITIES.—
(A) IN
GENERAL.—Subject to subpara-
graph (B), any activity of a medical self-regu-
latory entity relating to standard setting or
standard enforcement activities that are de-
signed to promote the quality of health care
provided to patients.
(B) EXCEPTION.—No activity of a medical
self-regulatory entity may be deemed to fall
under the safe harbor established under this
paragraph if the activity is conducted for pur-
poses of financial gain.
(3) PARTICIPATION IN SURVEYS.—The partici-
pation of a provider of health care services in a writ-
ten survey of the prices of services, reimbursement
levels, or the compensation and benefits of employ-
ees and personnel, but only if—
(A) the survey is conducted by a third
party, such as a purchaser of health care serv-
ices, governmental entity, institution of higher
education, or trade association;
(B) the information provided by partici-
pants in the survey is based on prices charged,
reimbursements received, or compensation and
benefits paid prior to the third month preceding
the month in which the information is provided;
and
(C) if the results of the survey are dissemi-
nated, the results are aggregated in a manner
that ensures that no recipient of the results
may identify the prices charged, reimbursement
received, or compensation and benefits paid by
any particular provider.
(4) JOINT VENTURES FOR HIGH TECHNOLOGY
AND COSTLY EQUIPMENT AND SERVICES.—Any ac-
tivity of a health care cooperative venture relating to
the purchase, operation, or marketing of high tech-
nology or other expensive medical equipment, or the
provision of high cost or complex services, but only
if the number of participants in the venture does not
exceed the lowest number needed to support the ven-
ture together with any other providers for whom the
participation in the venture is the only means of ob-
taining or operating such equipment or providing
such services.
(5) HOSPITAL MERGERS.—Activities relating to
a merger of 2 hospitals if, during the 3-year period
preceding the merger, one of the hospitals had an
average of 150 or fewer operational beds and an av-
erage daily inpatient census of less than 50 percent
of such beds.
(6) JOINT PURCHASING ARRANGEMENTS.—Any
joint purchasing arrangement among health care
providers if—
(A) the purchases under the arrangement
represent less than 35 percent of the total sales
of the product purchased in the relevant market
area; and
(B) the amounts paid under the arrange-
ment represent less than 20 percent of the total
revenues of the supplier of the product pur-
chased.
(7) NEGOTIATIONS.—Activities consisting of
good faith negotiations to carry out any activity—
(A) described in this section,
(B) within an additional safe harbor des-
ignated by the Attorney General under section
4,
(C) that is the subject of an application for
a certificate of review under section 5, or
(D) that is deemed a submission of a noti-
fication under section 6(a)(2)(B),
without regard to whether such an activity is carried
out.
SEC. 4. DESIGNATION OF ADDITIONAL SAFE HARBORS.
(a) IN GENERAL.—
(1) SOLICITATION OF PROPOSALS.—Not later
than 30 days after the date of the enactment of this
Act, the Attorney General shall publish a notice in
the Federal Register soliciting proposals for addi-
tional safe harbors.
(2) REVIEW AND REPORT ON PROPOSED SAFE
HARBORS.—Not later than 180 days after the date
of the enactment of this Act, the Attorney General
(in consultation with the Secretary of Health and
Human Services and the Chair of the Federal Trade
Commission) shall—
(A) review the proposed safe harbors sub-
mitted under paragraph (1); and
(B) submit a report to Congress describing
the proposals to be included in the publication
of additional safe harbors described in para-
graph (3) and the proposals that are not to be
so included, together with explanations there-
fore.
(3) PUBLICATION OF ADDITIONAL SAFE HAR-
BORS.—Not later than 180 days after the date of
the enactment of this Act, the Attorney General (in
consultation with the Secretary of Health and
Human Services and the Chair of the Federal Trade
Commission) shall publish in the Federal Register
proposed additional safe harbors for purposes of sec-
tion 2(a)(2) for providers of health care services.
Not later than 180 days after publishing such pro-
posed safe harbors in the Federal Register, the At-
torney General shall issue final rules establishing
such safe harbors.
(b) CRITERIA FOR SAFE HARBORS.—In establishing
safe harbors under subsection (a), the Attorney General
shall take into account the following:
(1) The extent to which a competitive or col-
laborative activity will accomplish any of the follow-
ing:
(A) An increase in access to health care
services.
(B) The enhancement of the quality of
health care services.
(C) The establishment of cost efficiencies
that will be passed on to consumers, including
economies of scale and reduced transaction and
administrative costs.
(D) An increase in the ability of health
care facilities to provide services in medically
underserved areas or to medically underserved
populations.
(E) An improvement in the utilization of
health care resources or the reduction in the in-
efficient duplication of the use of such re-
sources.
(2) Whether the designation of an activity as a
safe harbor under subsection (a) will result in the
following outcomes:
(A) Health plans and other health care in-
surers, consumers of health care services, and
health care providers will be better able to ne-
gotiate payment and service arrangements
which will reduce costs to consumers.
(B) Taking into consideration the charac-
teristics of the particular purchasers and pro-
viders involved, competition will not be unduly
restricted.
(C) Equally efficient and less restrictive al-
ternatives do not exist to meet the criteria de-
scribed in paragraph (1).
(D) The activity will not unreasonably
foreclose competition by denying competitors a
necessary element of competition.
SEC. 5. CERTIFICATES OF REVIEW.
(a) ESTABLISHMENT OF PROGRAM.—In consultation
with the Secretary and the Chair, the Attorney General
shall (not later than 180 days after the date of the enact-
ment of this Act) issue certificates of review in accordance
with this section for providers of health care services and
advise and assist any person with respect to applying for
such a certificate of review.
(b) PROCEDURES FOR APPLICATION FOR CERTIFI-
CATE.—
(1) FORM; CONTENT.—To apply for a certifi-
cate of review, a person shall submit to the Attorney
General a written application which—
(A) specifies the activities relating to the
provision of health care services which satisfy
the criteria described in section 4(b) and which
will be included in the certificate; and
(B) is in a form and contains any informa-
tion, including information pertaining to the
overall market in which the applicant operates,
required by rule or regulation promulgated
under section 8.
(2) PUBLICATION OF NOTICE IN FEDERAL REG-
ISTER.—Within 10 days after an application submit-
ted under paragraph (1) is received by the Attorney
General, the Attorney General shall publish in the
Federal Register a notice that announces that an
application for a certificate of review has been sub-
mitted, identifies each person submitting the appli-
cation, and describes the conduct for which the ap-
plication is submitted.
(3) ESTABLISHMENT OF PROCEDURES FOR IS-
SUANCE OF CERTIFICATE.—In consultation with the
Chair and the Secretary, the Attorney General shall
establish procedures to be used in applying for and
in determining whether to approve an application for
a certificate of review under this title. Under such
procedures the Attorney General shall approve an
application if the Attorney General determines that
the activities to be covered under the certificate will
satisfy the criteria described in section 4(b) for addi-
tional safe harbors designated under such section
and that the benefits of the issuance of the certifi-
cate will outweigh any disadvantages that may result
from reduced competition.
(4) TIMING FOR DECISION ON APPLICATION.—
(A) IN GENERAL.—Within 90 days after
the Attorney General receives an application for
a certificate of review, the Attorney General
shall determine whether the applicant’s health
care market activities are in accordance with
the procedures described in paragraph (3). If
the Attorney General, with the concurrence of
the Secretary, determines that such procedures
are met, the Attorney General shall issue to the
applicant a certificate of review. The certificate
of review shall specify—
(i) the health care market activities to
which the certificate applies,
(ii) the person to whom the certificate
of review is issued, and
(iii) any terms and conditions the At-
torney General or the Secretary deems nec-
essary to assure compliance with the appli-
cable procedures described in paragraph
(3).
(B) APPLICATIONS DEEMED APPROVED.—
If the Attorney General does not reject an ap-
plication before the expiration of the 90-period
beginning on the date the Attorney General re-
ceives the application, the Attorney General
shall be deemed to have approved the applica-
tion and to have issued a certificate of review
relating to the applicant’s health care market
activities covered under the application.
(5) EXPEDITED ACTION.—If the applicant indi-
cates a special need for prompt disposition, the At-
torney General and the Secretary may expedite ac-
tion on the application, except that no certificate of
review may be issued within 30 days of publication
of notice in the Federal Register under subsection
(b)(2).
(6) ACTIONS UPON DENIAL.—
(A) NOTIFICATION.—If the Attorney Gen-
eral denies in whole or in part an application
for a certificate, the Attorney General shall no-
tify the applicant of the Attorney General’s de-
termination and the reasons for it.
(B) REQUEST
FOR
RECONSIDERATION.—
An applicant may, within 30 days of receipt of
notification that the application has been denied
in whole or in part, request the Attorney Gen-
eral to reconsider the determination. The Attor-
ney General, with the concurrence of the Sec-
retary, shall notify the applicant of the deter-
mination upon reconsideration within 30 days
of receipt of the request.
(C) RETURN OF DOCUMENTS.—If the At-
torney General denies an application for the is-
suance of a certificate of review and thereafter
receives from the applicant a request for the re-
turn of documents submitted by the applicant
in connection with the application for the cer-
tificate, the Attorney General and the Secretary
shall return to the applicant, not later than 30
days after receipt of the request, the documents
and all copies of the documents available to the
Attorney General and the Secretary, except to
the extent that the information has been made
public under an exception to the rule against
public 
disclosure 
described 
in 
subsection
(g)(2)(B).
(7) FRAUDULENT
PROCUREMENT.—A certifi-
cate of review shall be void ab initio with respect to
any health care market activities for which the cer-
tificate was procured by fraud.
(c) AMENDMENT
AND REVOCATION
OF CERTIFI-
CATES.—
(1) NOTIFICATION
OF
CHANGES.—Any appli-
cant who receives a certificate of review—
(A) shall promptly report to the Attorney
General any change relevant to the matters
specified in the certificate; and
(B) may submit to the Attorney General
an application to amend the certificate to re-
flect the effect of the change on the conduct
specified in the certificate.
(2) AMENDMENT TO CERTIFICATE.—An appli-
cation for an amendment to a certificate of review
shall be treated as an application for the issuance of
a certificate. The effective date of an amendment
shall be the date on which the application for the
amendment is submitted to the Attorney General.
(3) REVOCATION.—
(A) GROUNDS FOR REVOCATION.—In ac-
cordance with this paragraph, the Attorney
General may revoke in whole or in part a cer-
tificate of review issued under this section. The
following shall be considered grounds for the
revocation of a certificate:
(i) After the expiration of the 2-year
period beginning on the date a person’s
certificate is issued, the activities of the
person have not substantially accomplished
the purposes for the issuance of the certifi-
cate.
(ii) The person has failed to comply
with any of the terms or conditions im-
posed under the certificate by the Attorney
General or the Secretary under subsection
(b)(4).
(iii) The activities covered under the
certificate no longer satisfy the criteria set
forth in section 4(b).
(B) REQUEST FOR COMPLIANCE INFORMA-
TION.—If the Attorney General or Secretary
has reason to believe that any of the grounds
for revocation of a certificate of review de-
scribed in subparagraph (A) may apply to a
person holding the certificate, the Attorney
General shall request such information from
such person as the Attorney General or the Sec-
retary deems necessary to resolve the matter of
compliance. Failure to comply with such request
shall be grounds for revocation of the certificate
under this paragraph.
(C) PROCEDURES
FOR
REVOCATION.—If
the Attorney General or the Secretary deter-
mines that any of the grounds for revocation of
a certificate of review described in subpara-
graph (A) apply to a person holding the certifi-
cate, or that such person has failed to comply
with a request made under subparagraph (B),
the Attorney General shall give written notice of
the determination to such person. The notice
shall include a statement of the circumstances
underlying, and the reasons in support of, the
determination. In the 60-day period beginning
30 days after the notice is given, the Attorney
General shall revoke the certificate or modify it
as the Attorney General or the Secretary deems
necessary to cause the certificate to apply only
to activities that meet the procedures for the is-
suance of certificates described in subsection
(b)(2).
(D) 
INVESTIGATION
AUTHORITY.—For
purposes of carrying out this paragraph, the
Attorney General may conduct investigations in
the same manner as the Attorney General con-
ducts investigations under section 3 of the Anti-
trust Civil Process Act, except that no civil in-
vestigative demand may be issued to a person
to whom a certificate of review is issued if such
person is the target of such investigation.
(d) REVIEW OF DETERMINATIONS.—
(1) AVAILABILITY OF REVIEW FOR CERTAIN AC-
TIONS.—If the Attorney General denies, in whole or
in part, an application for a certificate of review or
for an amendment to a certificate, or revokes or
modifies a certificate pursuant to paragraph (3), the
applicant or certificate holder (as the case may be)
may, within 30 days of the denial or revocation,
bring an action in any appropriate district court of
the United States to set aside the determination on
the ground that such determination is erroneous
based on the preponderance of the evidence.
(2) NO
OTHER
REVIEW
PERMITTED.—Except
as provided in paragraph (1), no action by the At-
torney General or the Secretary pursuant to this
title shall be subject to judicial review.
(3) EFFECT
OF
REJECTED
APPLICATION.—If
the Attorney General denies, in whole or in part, an
application for a certificate of review or for an
amendment to a certificate, or revokes or amends a
certificate, neither the negative determination nor
the statement of reasons therefore shall be admissi-
ble in evidence, in any administrative or judicial pro-
ceeding, concerning any claim under the antitrust
laws.
(e) PUBLICATION
OF DECISIONS.—The Attorney
General shall publish a notice in the Federal Register on
a timely basis of each decision made with respect to an
application for a certificate of review under this section
or the amendment or revocation of such a certificate, in
a manner that protects the confidentiality of any propri-
etary information relating to the application.
(f) ANNUAL REPORTS.—Every person to whom a cer-
tificate of review is issued shall submit to the Attorney
General an annual report, in such form and at such time
as the Attorney General may require, that contains any
necessary updates to the information required under sub-
section (b) and a description of the activities of the holder
under the certificate during the preceding year.
(g) RESTRICTIONS ON DISCLOSURE OF INFORMA-
TION.—
(1) WAIVER
OF
DISCLOSURE
REQUIREMENTS
UNDER
ADMINISTRATIVE
PROCEDURE
ACT.—Infor-
mation submitted by any person in connection with
the issuance, amendment, or revocation of a certifi-
cate of review shall be exempt from disclosure under
section 552 of title 5, United States Code.
(2) RESTRICTIONS
ON
DISCLOSURE
OF
COM-
MERCIAL OR FINANCIAL INFORMATION.—
(A) IN GENERAL.—Except as provided in
subparagraph (B), no officer or employee of the
United States shall disclose commercial or fi-
nancial information submitted in connection
with the issuance, amendment, or revocation of
a certificate of review if the information is priv-
ileged or confidential and if disclosure of the in-
formation would cause harm to the person who
submitted the information.
(B) 
EXCEPTIONS.—Subparagraph 
(A)
shall not apply with respect to information dis-
closed—
(i) upon a request made by the Con-
gress or any committee of the Congress,
(ii) in a judicial or administrative pro-
ceeding, subject to appropriate protective
orders,
(iii) with the consent of the person
who submitted the information,
(iv) in the course of making a deter-
mination with respect to the issuance,
amendment, or revocation of a certificate
of review, if the Attorney General deems
disclosure of the information to be nec-
essary in connection with making the
determination,
(v) in accordance with any require-
ment imposed by a statute of the United
States, or
(vi) in accordance with any rule or
regulation promulgated under subsection
(i) permitting the disclosure of the infor-
mation to an agency of the United States
or of a State on the condition that the
agency will disclose the information only
under 
the 
circumstances 
specified 
in
clauses (i) through (v).
(3) PROHIBITION AGAINST USE OF INFORMA-
TION TO SUPPORT OR ANSWER CLAIMS UNDER ANTI-
TRUST LAWS.—Any information disclosed in an ap-
plication for a certificate of review under this section
shall only be admissible into evidence in a judicial or
administrative proceeding for the sole purpose of
establishing that a person is entitled to the protec-
tions provided by such a certificate.
SEC. 6. NOTIFICATIONS PROVIDING REDUCTION IN CER-
TAIN PENALTIES UNDER ANTITRUST LAW
FOR 
HEALTH 
CARE 
COOPERATIVE 
VEN-
TURES.
(a) NOTIFICATIONS DESCRIBED.—
(1) SUBMISSION
OF
NOTIFICATION
BY
VEN-
TURE.—Any party to a health care cooperative ven-
ture, acting on such venture’s behalf, may, not later
than 90 days after entering into a written agreement
to form such venture or not later than 90 days after
the date of the enactment of this Act, whichever is
later, file with the Attorney General a written notifi-
cation disclosing—
(A) the identities of the parties to such
venture,
(B) the nature and objectives of such ven-
ture, and
(C) such additional information as the At-
torney General may require by regulation.
(2) ACTIVITIES DEEMED SUBMISSION OF NOTI-
FICATION.—The following health care cooperative
ventures shall be deemed to have filed a written noti-
fication with respect to the venture under paragraph
(1):
(A) SUBMISSION
OF
APPLICATION
FOR
CERTIFICATE OF REVIEW.—Any health care co-
operative venture for which an application for a
certificate of review is filed with the Attorney
General under section 4.
(B) ENGAGING IN RISK-SHARING ACTIVI-
TIES UNDER VENTURE.—Any health care coop-
erative venture whose members engage in risk-
sharing arrangements, including (but not lim-
ited to)—
(i) the acceptance of capitation con-
tracts;
(ii) the acceptance of contracts with
fee withholding mechanisms relating to the
ability to meet established goals for utiliza-
tion review and management; and
(iii) the holding by members of signifi-
cant ownership or equity interests in the
venture, where the capital contributed by
the members is used to fund the oper-
ational costs of the venture such as admin-
istration, marketing, and computer-oper-
ated medical information, if the venture
develops and operates comprehensive pro-
grams for utilization management and
quality assurance that include controls
over the use of institutional, specialized,
and ancillary medical services.
(C) VENTURES
BELOW
CERTAIN
SIZE.—
Any health care cooperative venture consisting
of a network of providers not greater than—
(i) in the case of a nonexclusive net-
work in which the participating members
are permitted to create or join other com-
peting networks, 50 percent of the provid-
ers of health care services in the relevant
geographic area and 50 percent of the
members of the provider specialty group in
the relevant market area; or
(ii) in the case of an exclusive network
in which the participating members are not
permitted to create or join other competing
networks, 35 percent of the providers of
health care services in the relevant geo-
graphic area and 35 percent of the mem-
bers of the provider specialty group in the
relevant market area.
(3) SUBMISSION
OF
ADDITIONAL
INFORMA-
TION.—
(A) REQUEST OF ATTORNEY GENERAL.—
At any time after receiving a notification filed
under paragraph (1), the Attorney General may
require the submission of additional information
or documentary material relevant to the pro-
posed health care cooperative venture.
(B) PARTIES TO VENTURE.—Any party to
a health care cooperative venture may submit
such additional information on the venture’s be-
half as may be appropriate to ensure that the
venture will receive the protections provided
under subsection (b).
(C) REQUIRED SUBMISSION OF INFORMA-
TION
ON
CHANGES
TO
VENTURE.—A health
care cooperative venture for which a notification
is in effect under this section shall submit infor-
mation on any change in the membership of the
venture not later than 90 days after such
change occurs.
(4) PUBLICATION OF NOTIFICATION.—
(A) INFORMATION MADE PUBLICLY AVAIL-
ABLE.—Not later than 30 days after receiving
a notification with respect to a venture under
paragraph (1), the Attorney General shall pub-
lish in the Federal Register a notice with re-
spect to the venture that identifies the parties
to the venture and generally describes the pur-
pose and planned activity of the venture. Prior
to its publication, the contents of the notice
shall be made available to the parties to the
venture.
(B) RESTRICTION
ON
DISCLOSURE
OF
OTHER
INFORMATION.—All information and
documentary material submitted pursuant to
this section and all information obtained by the
Attorney General in the course of any investiga-
tion or case with respect to a potential violation
of the antitrust laws by the health care coopera-
tive venture (other than information and mate-
rial described in subparagraph (A)) shall be ex-
empt from disclosure under section 552 of title
5, United States Code, and shall not be made
publicly available by any agency of the United
States to which such section applies except in
a judicial proceeding in which such information
and material is subject to any protective order.
(5) WITHDRAWAL OF NOTIFICATION.—Any per-
son who files a notification pursuant to this section
may withdraw such notification before a publication
by the Attorney General pursuant to paragraph (4).
Any person who is deemed to have filed a notifica-
tion under paragraph (2)(A) shall be deemed to have
withdrawn the notification if the certificate of review
in question is revoked or withdrawn under section 5.
(6) NO
JUDICIAL
REVIEW
PERMITTED.—Any
action taken or not taken by the Attorney General
with respect to notifications filed pursuant to this
subsection shall not be subject to judicial review.
(b) PROTECTIONS FOR VENTURES SUBJECT TO NO-
TIFICATION.—
(1) IN GENERAL.—
(A) PROTECTIONS DESCRIBED.—The pro-
visions of paragraphs (2), (3), (4), and (5) shall
apply with respect to any action under the anti-
trust laws challenging conduct within the scope
of a notification which is in effect pursuant to
subsection (a)(1).
(B) TIMING OF PROTECTIONS.—The pro-
tections described in this subsection shall apply
to the venture that is the subject of a notifica-
tion under subsection (a)(1) as of the earlier
of—
(i) the date of the publication in the
Federal Register of the notice published
with respect to the notification; or
(ii) if such notice is not published dur-
ing the period required under subsection
(a)(4), the expiration of the 30-day period
that begins on the date the Attorney Gen-
eral receives any necessary information re-
quired to be submitted under subsection
(a)(1) or any additional information re-
quired by the Attorney General under sub-
section (a)(3)(A).
(2) APPLICABILITY
OF
RULE
OF
REASON
STANDARD.—In any action under the antitrust laws,
the conduct of any person which is within the scope
of a notification filed under subsection (a) shall not
be deemed illegal per se, but shall be judged on the
basis of its reasonableness, taking into account all
relevant factors affecting competition, including, but
not limited to, effects on competition in relevant
markets.
(3) LIMITATION
ON
RECOVERY
TO
ACTUAL
DAMAGES AND INTEREST.—Notwithstanding section
4 of the Clayton Act, any person who is entitled to
recovery under the antitrust laws for conduct that is
within the scope of a notification filed under sub-
section (a) shall recover the actual damages sus-
tained by such person and interest calculated at the
rate specified in section 1961 of title 28, United
States Code, for the period beginning on the earliest
date for which injury can be established and ending
on the date of judgment, unless the court finds that
the award of all or part of such interest is unjust
under the circumstances.
(4) AWARD OF ATTORNEY’S FEES AND COSTS
OF SUIT.—
(A) IN GENERAL.—In any action under the
antitrust laws brought against a health care co-
operative venture for conduct that is within the
scope of a notification filed under subsection
(a), the court shall, at the conclusion of the ac-
tion—
(i) award to a substantially prevailing
claimant the cost of suit attributable to
such claim, including a reasonable attor-
ney’s fee, or
(ii) award to a substantially prevailing
party defending against such claim the
cost of such suit attributable to such claim,
including reasonable attorney’s fee, if the
claim, or the claimant’s conduct during
litigation of the claim, was frivolous, un-
reasonable, without foundation, or in bad
faith.
(B) OFFSET IN CASES OF BAD FAITH.—
The court may reduce an award made pursuant
to subparagraph (A) in whole or in part by an
award in favor of another party for any part of
the cost of suit (including a reasonable attor-
ney’s fee) attributable to conduct during the
litigation by any prevailing party that the court
finds to be frivolous, unreasonable, without
foundation, or in bad faith.
(5) RESTRICTIONS
ON
ADMISSIBILITY
OF
IN-
FORMATION.—
(A) IN
GENERAL.—Any information dis-
closed in a notification submitted under sub-
section (a)(1) and the fact of the publication of
a notification by the Attorney General under
subsection (a)(4) shall only be admissible into
evidence in a judicial or administrative proceed-
ing for the sole purpose of establishing that a
party to a health care cooperative venture is en-
titled to the protections described in this sub-
section.
(B) ACTIONS OF ATTORNEY GENERAL.—
No action taken by the Attorney General pursu-
ant to this section shall be admissible into evi-
dence in any judicial or administrative proceed-
ing for the purpose of supporting or answering
any claim under the antitrust laws.
SEC. 7. REVIEW AND REPORTS ON SAFE HARBORS AND
CERTIFICATES OF REVIEW.
(a) IN GENERAL.—The Attorney General (in con-
sultation with the Secretary and the Chair) shall periodi-
cally review the safe harbors described in section 3, the
additional safe harbors designated under section 4, and
the certificates of review issued under section 5, and—
(1) with respect to the safe harbors described in
section 3, submit such recommendations to Congress
as the Attorney General considers appropriate for
modifications of such safe harbors;
(2) with respect to the additional safe harbors
under designated under section 4, issue proposed re-
visions to such activities and publish the revisions in
the Federal Register; and
(3) with respect to the certificates of review,
submit a report to Congress on the issuance of such
certificates, and shall include in the report a descrip-
tion of the effect of such certificates on increasing
access to high quality health care services at reduced
costs.
(b) RECOMMENDATIONS
FOR LEGISLATION.—The
Attorney General shall include in the reports submitted
under subsection (a)(3) any recommendations of the At-
torney General for legislation to improve the program for
the issuance of certificates of review established under this
title.
SEC. 8. RULES, REGULATIONS, AND GUIDELINES.
(a) SAFE HARBORS, CERTIFICATES, AND NOTIFICA-
TIONS.—The Attorney General, with the concurrence of
the Secretary, shall promulgate such rules, regulations,
and guidelines as are necessary to carry out sections 3,
4, 5, and 6, including guidelines relating to appropriate
geographic and product areas for health care services and
providers of health care services.
(b) GUIDANCE FOR PROVIDERS.—
(1) IN
GENERAL.—To promote greater cer-
tainty regarding the application of the antitrust laws
to activities in the health care market, the Attorney
General, in consultation with the Secretary and the
Chair, shall (not later than 1 year after the date of
the enactment of this Act), taking into account the
criteria used to designate additional safe harbors
under section 4 and grant certificates of review
under section 5, publish guidelines—
(A) to assist providers of health care serv-
ices in analyzing whether the activities of such
providers may be subject to a safe harbor under
sections 3 or 4; and
(B) describing specific types of activities
which would meet the requirements for a cer-
tificate of review under section 5, and summa-
rizing the factual and legal bases on which the
activities would meet the requirements.
(2) PERIODIC UPDATE.—The Attorney General
shall periodically update the guidelines published
under paragraph (1) as the Attorney General consid-
ers appropriate.
(3) WAIVER OF ADMINISTRATIVE PROCEDURE
ACT.—Section 553 of title 5, United States Code,
shall not apply to the issuance of guidelines under
paragraph (1).
SEC. 9. ESTABLISHMENT OF HHS OFFICE OF HEALTH CARE
COMPETITION POLICY.
(a) IN GENERAL.—There is established within the
Department of Health and Human Services an Office to
be known as the Office of Health Care Competition Policy
(hereafter in this section referred to as the ‘‘Office’’). The
Office shall be headed by a director, who shall be ap-
pointed by the Secretary.
(b) DUTIES.—The Office shall coordinate the respon-
sibilities of the Secretary under this Act and otherwise as-
sist the Secretary in developing policies relating to the
competitive and collaborative activities of providers of
health care services.
SEC. 10. DEFINITIONS.
In this Act, the following definitions shall apply:
(1) The term ‘‘antitrust laws’’—
(A) has the meaning given it in subsection
(a) of the first section of the Clayton Act (15
U.S.C. 12(a)), except that such term includes
section 5 of the Federal Trade Commission Act
(15 U.S.C. 45) to the extent such section ap-
plies to unfair methods of competition; and
(C) the development and implementation of
practice guidelines or practice parameters, or
(D) official peer review proceedings under-
taken by a hospital medical staff (or committee
thereof) or a medical society or association for
purposes of evaluating the professional conduct
or quality of health care provided by a medical
professional.
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