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[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3486 Introduced in House (IH)]

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. Brewster, 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. 
   Montgomery, 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. Rogers, 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. Solomon, Mr. Armey, Mr. Goodlatte, Mr. Packard, Mr. 
Zimmer, Mr. Peterson of Minnesota, Mr. DeFazio, Ms. McKinney, Mr. Roth, 
Mr. Hansen, Mr. Barca of Wisconsin, Mr. Deutsch, Mr. Mica, Mr. Castle, 
  Ms. Dunn, Mr. McInnis, Mr. Johnson of South Dakota, Mr. Hutto, Mr. 
 Rowland, Mr. Stearns, Mr. Payne of Virginia, Mr. Collins of Georgia, 
                             and Mr. Tauzin

                                 A BILL

 
 To establish safe harbors from the application of the antitrust laws 
 for certain activities of providers of health care services, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives 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 ACTIVITIES.

    (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 harbor 
        designated by the Attorney General under section 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 activity occurs--
                    (A) while the certificate is in effect, or
                    (B) in the case of a certificate issued during 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 action 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 subsection (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 paragraph (1) in whole or in part by an 
        award in favor of another party for any part of the cost of 
        suit (including 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 providers if the number of each type or 
        specialty of provider 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 subparagraph (B), any 
                activity of a medical self-regulatory entity relating 
                to standard setting or standard enforcement activities 
                that are designed 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 purposes of financial gain.
            (3) Participation in surveys.--The participation of a 
        provider of health care services in a written survey of the 
        prices of services, reimbursement levels, or the compensation 
        and benefits of employees and personnel, but only if--
                    (A) the survey is conducted by a third party, such 
                as a purchaser of health care services, governmental 
                entity, institution of higher education, or trade 
                association;
                    (B) the information provided by participants 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 disseminated, 
                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 activity of a health care cooperative 
        venture relating to the purchase, operation, or marketing of 
        high technology 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 venture together with any 
        other providers for whom the participation in the venture is 
        the only means of obtaining 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 average 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 arrangement 
                represent less than 20 percent of the total revenues of 
                the supplier of the product purchased.
            (7) Negotiations.--Activities consisting of good faith 
        negotiations to carry out any activity--
                    (A) described in this section,
                    (B) within an additional safe harbor designated 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 notification 
                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 additional 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 submitted 
                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 paragraph (3) and 
                the proposals that are not to be so included, together 
                with explanations therefore.
            (3) Publication of additional 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 publish in the Federal Register proposed 
        additional safe harbors for purposes of section 2(a)(2) for 
        providers of health care services. Not later than 180 days 
        after publishing such proposed safe harbors in the Federal 
        Register, the Attorney 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 collaborative 
        activity will accomplish any of the following:
                    (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 inefficient 
                duplication of the use of such resources.
            (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 insurers, 
                consumers of health care services, and health care 
                providers will be better able to negotiate payment and 
                service arrangements which will reduce costs to 
                consumers.
                    (B) Taking into consideration the characteristics 
                of the particular purchasers and providers involved, 
                competition will not be unduly restricted.
                    (C) Equally efficient and less restrictive 
                alternatives do not exist to meet the criteria 
                described 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 enactment 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 Certificate.--
            (1) Form; content.--To apply for a certificate 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 information, 
                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 register.--Within 10 
        days after an application submitted 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 submitted, 
        identifies each person submitting the application, and 
        describes the conduct for which the application is submitted.
            (3) Establishment of procedures for issuance 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 additional safe harbors 
        designated under such section and that the benefits of the 
        issuance of the certificate 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 Attorney 
                        General or the Secretary deems necessary to 
                        assure compliance with the applicable 
                        procedures described in paragraph (3).
                    (B) Applications deemed approved.--If the Attorney 
                General does not reject an application before the 
                expiration of the 90-period beginning on the date the 
                Attorney General receives the application, the Attorney 
                General shall be deemed to have approved the 
                application 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 indicates a special 
        need for prompt disposition, the Attorney General and the 
        Secretary may expedite action 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 General denies 
                in whole or in part an application for a certificate, 
                the Attorney General shall notify the applicant of the 
                Attorney General's determination 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 General to reconsider the 
                determination. The Attorney General, with the 
                concurrence of the Secretary, shall notify the 
                applicant of the determination upon reconsideration 
                within 30 days of receipt of the request.
                    (C) Return of documents.--If the Attorney General 
                denies an application for the issuance of a certificate 
                of review and thereafter receives from the applicant a 
                request for the return of documents submitted by the 
                applicant in connection with the application for the 
                certificate, 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 certificate of review shall 
        be void ab initio with respect to any health care market 
        activities for which the certificate was procured by fraud.
    (c) Amendment and Revocation of Certificates.--
            (1) Notification of changes.--Any applicant 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 reflect the 
                effect of the change on the conduct specified in the 
                certificate.
            (2) Amendment to certificate.--An application 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 accordance with 
                this paragraph, the Attorney General may revoke in 
                whole or in part a certificate 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 certificate.
                            (ii) The person has failed to comply with 
                        any of the terms or conditions imposed 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 information.--If the 
                Attorney General or Secretary has reason to believe 
                that any of the grounds for revocation of a certificate 
                of review described 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 Secretary 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 determines that any of the 
                grounds for revocation of a certificate of review 
                described in subparagraph (A) apply to a person holding 
                the certificate, 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 issuance 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 conducts investigations under section 
                3 of the Antitrust Civil Process Act, except that no 
                civil investigative 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 actions.--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 Attorney 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 
        admissible in evidence, in any administrative or judicial 
        proceeding, 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 proprietary information 
relating to the application.
    (f) Annual Reports.--Every person to whom a certificate 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 
subsection (b) and a description of the activities of the holder under 
the certificate during the preceding year.
    (g) Restrictions on Disclosure of Information.--
            (1) Waiver of disclosure requirements under administrative 
        procedure act.--Information submitted by any person in 
        connection with the issuance, amendment, or revocation of a 
        certificate of review shall be exempt from disclosure under 
        section 552 of title 5, United States Code.
            (2) Restrictions on disclosure of commercial or financial 
        information.--
                    (A) In general.--Except as provided in subparagraph 
                (B), no officer or employee of the United States shall 
                disclose commercial or financial information submitted 
                in connection with the issuance, amendment, or 
                revocation of a certificate of review if the 
                information is privileged or confidential and if 
                disclosure of the information would cause harm to the 
                person who submitted the information.
                    (B) Exceptions.--Subparagraph (A) shall not apply 
                with respect to information disclosed--
                            (i) upon a request made by the Congress or 
                        any committee of the Congress,
                            (ii) in a judicial or administrative 
                        proceeding, subject to appropriate protective 
                        orders,
                            (iii) with the consent of the person who 
                        submitted the information,
                            (iv) in the course of making a 
                        determination with respect to the issuance, 
                        amendment, or revocation of a certificate of 
                        review, if the Attorney General deems 
                        disclosure of the information to be necessary 
                        in connection with making the determination,
                            (v) in accordance with any requirement 
                        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 information 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 information to support or 
        answer claims under antitrust laws.--Any information disclosed 
        in an application 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 protections provided by such a 
        certificate.

SEC. 6. NOTIFICATIONS PROVIDING REDUCTION IN CERTAIN PENALTIES UNDER 
              ANTITRUST LAW FOR HEALTH CARE COOPERATIVE VENTURES.

    (a) Notifications Described.--
            (1) Submission of notification by venture.--Any party to a 
        health care cooperative venture, 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 notification 
        disclosing--
                    (A) the identities of the parties to such venture,
                    (B) the nature and objectives of such venture, and
                    (C) such additional information as the Attorney 
                General may require by regulation.
            (2) Activities deemed submission of notification.--The 
        following health care cooperative ventures shall be deemed to 
        have filed a written notification with respect to the venture 
        under paragraph (1):
                    (A) Submission of application for certificate of 
                review.--Any health care cooperative venture for which 
                an application for a certificate of review is filed 
                with the Attorney General under section 4.
                    (B) Engaging in risk-sharing activities under 
                venture.--Any health care cooperative venture whose 
                members engage in risk-sharing arrangements, including 
                (but not limited to)--
                            (i) the acceptance of capitation contracts;
                            (ii) the acceptance of contracts with fee 
                        withholding mechanisms relating to the ability 
                        to meet established goals for utilization 
                        review and management; and
                            (iii) the holding by members of significant 
                        ownership or equity interests in the venture, 
                        where the capital contributed by the members is 
                        used to fund the operational costs of the 
                        venture such as administration, marketing, and 
                        computer-operated medical information, if the 
                        venture develops and operates comprehensive 
                        programs 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 network 
                        in which the participating members are 
                        permitted to create or join other competing 
                        networks, 50 percent of the providers 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 geographic area 
                        and 35 percent of the members of the provider 
                        specialty group in the relevant market area.
            (3) Submission of additional information.--
                    (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 proposed 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 behalf as may be 
                appropriate to ensure that the venture will receive the 
                protections provided under subsection (b).
                    (C) Required submission of information on changes 
                to venture.--A health care cooperative venture for 
                which a notification is in effect under this section 
                shall submit information 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 available.--Not later 
                than 30 days after receiving a notification with 
                respect to a venture under paragraph (1), the Attorney 
                General shall publish in the Federal Register a notice 
                with respect to the venture that identifies the parties 
                to the venture and generally describes the purpose 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 
                investigation or case with respect to a potential 
                violation of the antitrust laws by the health care 
                cooperative venture (other than information and 
                material described in subparagraph (A)) shall be exempt 
                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 person 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 notification 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 Notification.--
            (1) In general.--
                    (A) Protections described.--The provisions of 
                paragraphs (2), (3), (4), and (5) shall apply with 
                respect to any action under the antitrust laws 
                challenging conduct within the scope of a notification 
                which is in effect pursuant to subsection (a)(1).
                    (B) Timing of protections.--The protections 
                described in this subsection shall apply to the venture 
                that is the subject of a notification 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 during 
                        the period required under subsection (a)(4), 
                        the expiration of the 30-day period that begins 
                        on the date the Attorney General receives any 
                        necessary information required to be submitted 
                        under subsection (a)(1) or any additional 
                        information required by the Attorney General 
                        under subsection (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 
        subsection (a) shall recover the actual damages sustained 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 cooperative venture 
                for conduct that is within the scope of a notification 
                filed under subsection (a), the court shall, at the 
                conclusion of the action--
                            (i) award to a substantially prevailing 
                        claimant the cost of suit attributable to such 
                        claim, including a reasonable attorney'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, unreasonable, 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 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.
            (5) Restrictions on admissibility of information.--
                    (A) In general.--Any information disclosed in a 
                notification submitted under subsection (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 proceeding for the sole purpose of 
                establishing that a party to a health care cooperative 
                venture is entitled to the protections described in 
                this subsection.
                    (B) Actions of attorney general.--No action taken 
                by the Attorney General pursuant to this section shall 
                be admissible into evidence in any judicial or 
                administrative proceeding 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 consultation with the 
Secretary and the Chair) shall periodically 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 revisions 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 description 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 Attorney 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 Notifications.--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 certainty 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 services 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 certificate of review 
                under section 5, and summarizing 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 considers 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 
appointed by the Secretary.
    (b) Duties.--The Office shall coordinate the responsibilities of 
the Secretary under this Act and otherwise assist 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 applies to unfair methods of competition; and
                    (B) includes any State law similar to the laws 
                referred to in subparagraph (A).
            (2) The term ``Chair'' means the Chair of the Federal Trade 
        Commission.
            (3) The term ``health benefit plan'' means any hospital or 
        medical expense incurred policy or certificate, hospital or 
        medical service plan contract, or health maintenance subscriber 
        contract, or a multiple employer welfare arrangement or 
        employee benefit plan (as defined under the Employee Retirement 
        Income Security Act of 1974) which provides benefits with 
        respect to health care services.
            (4) The term ``health care cooperative venture'' means any 
        activities, including attempts to enter into or perform a 
        contract or agreement, carried out by 2 or more persons for the 
        purpose of providing health care services.
            (5) The term ``health care services'' means any services 
        for which payment may be made under a health benefit plan, 
        including services related to the delivery or administration of 
        such services.
            (6) The term ``medical self-regulatory entity'' means a 
        medical society or association, a specialty board, a recognized 
        accrediting agency, or a hospital medical staff, and includes 
        the members, officers, employees, consultants, and volunteers 
        or committees of such an entity.
            (7) The term ``person'' includes a State or unit of local 
        government.
            (8) The term ``provider of health care services'' means any 
        individual or entity that is engaged in the delivery of health 
        care services in a State and that is required by State law or 
        regulation to be licensed or certified by the State to engage 
        in the delivery of such services in the State.
            (9) The term ``Secretary'' means the Secretary of Health 
        and Human Services.
            (10) The term ``specialty group'' means a medical specialty 
        or subspecialty in which a provider of health care services may 
        be licensed to practice by a State (as determined by the 
        Secretary in consultation with the certification boards for 
        such specialties and subspecialties).
            (11) The term ``standard setting and enforcement 
        activities'' means--
                    (A) accreditation of health care practitioners, 
                health care providers, medical education institutions, 
                or medical education programs,
                    (B) technology assessment and risk management 
                activities,
                    (C) the development and implementation of practice 
                guidelines or practice parameters, or
                    (D) official peer review proceedings undertaken 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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