[Congressional Record (Bound Edition), Volume 146 (2000), Part 9]
[Senate]
[Pages 13019-13053]
[From the U.S. Government Publishing Office, www.gpo.gov]



                          AMENDMENTS SUBMITTED

                                 ______
                                 

              DEPARTMENT OF LABOR APPROPRIATIONS ACT, 2001

                                 ______
                                 

                DASCHLE (AND OTHERS) AMENDMENT NO. 3688

  Mr. HARKIN (for Mr. Daschle (for himself, Mr. Kennedy, Mr. Harkin, 
Mr. Dodd, and Mr. Robb)) proposed an amendment to the bill (H.R. 4577) 
making appropriations for the Departments of Labor, Health and Human 
Services, and Education, and related agencies for the fiscal year 
ending September 30, 2001, and for other purposes; as follows:

       On page 92, between lines 4 and 5, insert the following:

 TITLE __ GENETIC NONDISCRIMINATION IN HEALTH INSURANCE AND EMPLOYMENT

     SEC. __01. SHORT TITLE.

       This title may be cited as the ``Genetic Nondiscrimination 
     in Health Insurance and Employment Act of 2000''.

Subtitle A--Prohibition of Health Insurance Discrimination on the Basis 
                   of Predictive Genetic Information

     SEC. __11. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

       (a) Amendments Relating to the Group Market.--
       (1) Prohibition of health insurance discrimination on the 
     basis of predictive genetic information or genetic 
     services.--
       (A) No enrollment restriction for genetic services.--
     Section 2702(a)(1)(F) of the Public Health Service Act (42 
     U.S.C. 300gg-1(a)(1)(F)) is amended by inserting before the 
     period the following: ``(or information about a request for 
     or the receipt of genetic services by an individual or a 
     family member of such individual)''.
       (B) No discrimination in group rate based on predictive 
     genetic information.--
       (i) In general.--Subpart 2 of part A of title XXVII of the 
     Public Health Service (42 U.S.C. 300gg-4 et seq.) is amended 
     by adding at the end the following:

     ``SEC. 2707. PROHIBITING DISCRIMINATION AGAINST GROUPS ON THE 
                   BASIS OF PREDICTIVE GENETIC INFORMATION.

       ``A group health plan, and a health insurance issuer 
     offering group health insurance coverage in connection with a 
     group health plan, shall not deny eligibility to a group or 
     adjust premium or contribution rates for a group on the basis 
     of predictive genetic information concerning an individual in 
     the group (or information about a request for or the receipt 
     of genetic services by such individual or family member of 
     such individual).''.
       (ii) Conforming amendments.--

       (I) Section 2702(b)(2)(A) of the Public Health Service Act 
     (42 U.S.C. 300gg-1(b)(2)(A)) is amended to read as follows:

       ``(A) to restrict the amount that an employer may be 
     charged for coverage under a group health plan, except as 
     provided in section 2707; or''.

       (II) Section 2721(a) of the Public Health Service Act (42 
     U.S.C. 300gg-21(a)) is amended by inserting ``(other than 
     subsections (a)(1)(F), (b) (with respect to cases relating to 
     genetic information or information about a request or receipt 
     of genetic services by an individual or family member of such 
     individual), (c), (d), (e), (f), or (g) of section 2702 and 
     section 2707)'' after ``subparts 1 and 3''.

       (2) Limitations on genetic testing and on collection and 
     disclosure of predictive genetic information.--Section 2702 
     of the Public Health Service Act (42 U.S.C. 300gg-1) is 
     amended by adding at the end the following:
       ``(c) Genetic Testing.--
       ``(1) Limitation on requesting or requiring genetic 
     testing.--A group health plan, or a health insurance issuer 
     offering health insurance coverage in connection with a group 
     health plan, shall not request or require an individual or a 
     family member of such individual to undergo a genetic test.
       ``(2) Rule of construction.--Nothing in this title shall be 
     construed to limit the authority of a health care 
     professional, who is providing treatment with respect to an 
     individual and who is employed by a group health plan or a 
     health insurance issuer, to request that such individual or 
     family member of such individual undergo a genetic test. Such 
     a health care professional shall not require that such 
     individual or family member undergo a genetic test.
       ``(d) Collection of Predictive Genetic Information.--Except 
     as provided in subsections (f) and (g), a group health plan, 
     or a health insurance issuer offering health insurance 
     coverage in connection with a group health plan, shall not 
     request, require, collect, or purchase predictive genetic 
     information concerning an individual (or information about a 
     request for or the receipt of genetic services by such 
     individual or family member of such individual).
       ``(e) Disclosure of Predictive Genetic Information.--A 
     group health plan, or a health insurance issuer offering 
     health insurance coverage in connection with a group health 
     plan, shall not disclose predictive genetic information about 
     an individual (or information about a request for or the 
     receipt of genetic services by such individual or family 
     member of such individual) to--
       ``(1) any entity that is a member of the same controlled 
     group as such issuer or plan sponsor of such group health 
     plan;
       ``(2) any other group health plan or health insurance 
     issuer or any insurance agent, third party administrator, or 
     other person subject to regulation under State insurance 
     laws;
       ``(3) the Medical Information Bureau or any other person 
     that collects, compiles, publishes, or otherwise disseminates 
     insurance information;
       ``(4) the individual's employer or any plan sponsor; or
       ``(5) any other person the Secretary may specify in 
     regulations.
       ``(f) Information for Payment for Genetic Services.--
       ``(1) In general.--With respect to payment for genetic 
     services conducted concerning an individual or the 
     coordination of benefits, a group health plan, or a health 
     insurance issuer offering group health insurance coverage in 
     connection with a group health plan, may request that the 
     individual provide the plan or issuer with evidence that such 
     services were performed.
       ``(2) Rule of construction.--Nothing in paragraph (1) shall 
     be construed to--
       ``(A) permit a group health plan or health insurance issuer 
     to request (or require) the results of the services referred 
     to in such paragraph; or
       ``(B) require that a group health plan or health insurance 
     issuer make payment for services described in such paragraph 
     where the individual involved has refused to provide evidence 
     of the performance of such services pursuant to a request by 
     the plan or issuer in accordance with such paragraph.
       ``(g) Information for Payment of Other Claims.--With 
     respect to the payment of claims for benefits other than 
     genetic services, a group health plan, or a health insurance 
     issuer offering group health insurance coverage in connection 
     with a group health plan, may request that an individual 
     provide predictive genetic information so long as such 
     information--
       ``(1) is used solely for the payment of a claim;
       ``(2) is limited to information that is directly related to 
     and necessary for the payment of such claim and the claim 
     would otherwise be denied but for the predictive genetic 
     information; and
       ``(3) is used only by an individual (or individuals) within 
     such plan or issuer who needs access to such information for 
     purposes of payment of a claim.
       ``(h) Rules of Construction.--
       ``(1) Collection or disclosure authorized by individual.--
     The provisions of subsections (d) (regarding collection) and 
     (e) shall not apply to an individual if the individual (or 
     legal representative of the individual) provides prior, 
     knowing, voluntary, and written authorization for the 
     collection or disclosure of predictive genetic information.
       ``(2) Disclosure for health care treatment.--Nothing in 
     this section shall be construed to limit or restrict the 
     disclosure of predictive genetic information from a health 
     care provider to another health care provider

[[Page 13020]]

     for the purpose of providing health care treatment to the 
     individual involved.
       ``(i) Definitions.--In this section:
       ``(1) Controlled group.--The term `controlled group' means 
     any group treated as a single employer under subsections (b), 
     (c), (m), or (o) of section 414 of the Internal Revenue Code 
     of 1986.
       ``(2) Group health plan, health insurance issuer.--The 
     terms `group health plan' and `health insurance issuer' 
     include a third party administrator or other person acting 
     for or on behalf of such plan or issuer.''.
       (3) Definitions.--Section 2791(d) of the Public Health 
     Service Act (42 U.S.C. 300gg-91(d)) is amended by adding at 
     the end the following new paragraphs:
       ``(15) Family member.--The term `family member' means with 
     respect to an individual--
       ``(A) the spouse of the individual;
       ``(B) a dependent child of the individual, including a 
     child who is born to or placed for adoption with the 
     individual; and
       ``(C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       ``(16) Genetic information.--The term `genetic information' 
     means information about genes, gene products, or inherited 
     characteristics that may derive from an individual or a 
     family member of such individual (including information about 
     a request for or the receipt of genetic services by such 
     individual or family member of such individual).
       ``(17) Genetic services.--The term `genetic services' means 
     health services, including genetic tests, provided to obtain, 
     assess, or interpret genetic information for diagnostic and 
     therapeutic purposes, and for genetic education and 
     counselling.
       ``(18) Genetic test.--The term `genetic test' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites in order to detect genotypes, mutations, 
     or chromosomal changes.
       ``(19) Predictive genetic information.--
       ``(A) In general.--The term `predictive genetic 
     information' means--
       ``(i) information about an individual's genetic tests;
       ``(ii) information about genetic tests of family members of 
     the individual; or
       ``(iii) information about the occurrence of a disease or 
     disorder in family members.
       ``(B) Limitations.--The term `predictive genetic 
     information' shall not include--
       ``(i) information about the sex or age of the individual;
       ``(ii) information about chemical, blood, or urine analyses 
     of the individual, unless these analyses are genetic tests; 
     or
       ``(iii) information about physical exams of the individual, 
     and other information relevant to determining the current 
     health status of the individual.''.
       (b) Amendment Relating to the Individual Market.--The first 
     subpart 3 of part B of title XXVII of the Public Health 
     Service Act (42 U.S.C. 300gg-51 et seq.) is amended--
       (1) by redesignating such subpart as subpart 2; and
       (2) by adding at the end the following:

     ``SEC. 2753. PROHIBITION OF HEALTH INSURANCE DISCRIMINATION 
                   AGAINST INDIVIDUALS ON THE BASIS OF PREDICTIVE 
                   GENETIC INFORMATION.

       ``(a) In Eligibility To Enroll.--A health insurance issuer 
     offering health insurance coverage in the individual market 
     shall not establish rules for eligibility to enroll in 
     individual health insurance coverage that are based on 
     predictive genetic information concerning the individual (or 
     information about a request for or the receipt of genetic 
     services by such individual or family member of such 
     individual).
       ``(b) In Premium Rates.--A health insurance issuer offering 
     health insurance coverage in the individual market shall not 
     adjust premium rates on the basis of predictive genetic 
     information concerning an individual (or information about a 
     request for or the receipt of genetic services by such 
     individual or family member of such individual).

     ``SEC. 2754. LIMITATIONS ON GENETIC TESTING AND ON COLLECTION 
                   AND DISCLOSURE OF PREDICTIVE GENETIC 
                   INFORMATION.

       ``(a) Genetic Testing.--
       ``(1) Limitation on requesting or requiring genetic 
     testing.--A health insurance issuer offering health insurance 
     coverage in the individual market shall not request or 
     require an individual or a family member of such individual 
     to undergo a genetic test.
       ``(2) Rule of construction.--Nothing in this title shall be 
     construed to limit the authority of a health care 
     professional, who is providing treatment with respect to an 
     individual and who is employed by a group health plan or a 
     health insurance issuer, to request that such individual or 
     family member of such individual undergo a genetic test. Such 
     a health care professional shall not require that such 
     individual or family member undergo a genetic test.
       ``(b) Collection of Predictive Genetic Information.--Except 
     as provided in subsections (d) and (e), a health insurance 
     issuer offering health insurance coverage in the individual 
     market shall not request, require, collect, or purchase 
     predictive genetic information concerning an individual (or 
     information about a request for or the receipt of genetic 
     services by such individual or family member of such 
     individual).
       ``(c) Disclosure of Predictive Genetic Information.--A 
     health insurance issuer offering health insurance coverage in 
     the individual market shall not disclose predictive genetic 
     information about an individual (or information about a 
     request for or the receipt of genetic services by such 
     individual or family member of such individual) to--
       ``(1) any entity that is a member of the same controlled 
     group as such issuer or plan sponsor of such group health 
     plan;
       ``(2) any other group health plan or health insurance 
     issuer or any insurance agent, third party administrator, or 
     other person subject to regulation under State insurance 
     laws;
       ``(3) the Medical Information Bureau or any other person 
     that collects, compiles, publishes, or otherwise disseminates 
     insurance information;
       ``(4) the individual's employer or any plan sponsor; or
       ``(5) any other person the Secretary may specify in 
     regulations.
       ``(d) Information for Payment for Genetic Services.--
       ``(1) In general.--With respect to payment for genetic 
     services conducted concerning an individual or the 
     coordination of benefits, a health insurance issuer offering 
     health insurance coverage in the individual market may 
     request that the individual provide the plan or issuer with 
     evidence that such services were performed.
       ``(2) Rule of construction.--Nothing in paragraph (1) shall 
     be construed to--
       ``(A) permit a health insurance issuer to request (or 
     require) the results of the services referred to in such 
     paragraph; or
       ``(B) require that a health insurance issuer make payment 
     for services described in such paragraph where the individual 
     involved has refused to provide evidence of the performance 
     of such services pursuant to a request by the plan or issuer 
     in accordance with such paragraph.
       ``(e) Information for Payment of Other Claims.--With 
     respect to the payment of claims for benefits other than 
     genetic services, a health insurance issuer offering health 
     insurance coverage in the individual market may request that 
     an individual provide predictive genetic information so long 
     as such information--
       ``(1) is used solely for the payment of a claim;
       ``(2) is limited to information that is directly related to 
     and necessary for the payment of such claim and the claim 
     would otherwise be denied but for the predictive genetic 
     information; and
       ``(3) is used only by an individual (or individuals) within 
     such plan or issuer who needs access to such information for 
     purposes of payment of a claim.
       ``(f) Rules of Construction.--
       ``(1) Collection or disclosure authorized by individual.--
     The provisions of subsections (c) (regarding collection) and 
     (d) shall not apply to an individual if the individual (or 
     legal representative of the individual) provides prior, 
     knowing, voluntary, and written authorization for the 
     collection or disclosure of predictive genetic information.
       ``(2) Disclosure for health care treatment.--Nothing in 
     this section shall be construed to limit or restrict the 
     disclosure of predictive genetic information from a health 
     care provider to another health care provider for the purpose 
     of providing health care treatment to the individual 
     involved.
       ``(g) Definitions.--In this section:
       ``(1) Controlled group.--The term `controlled group' means 
     any group treated as a single employer under subsections (b), 
     (c), (m), or (o) of section 414 of the Internal Revenue Code 
     of 1986.
       ``(2) Group health plan, health insurance issuer.--The 
     terms `group health plan' and `health insurance issuer' 
     include a third party administrator or other person acting 
     for or on behalf of such plan or issuer.''.
       (c) Enforcement.--
       (1) Group plans.--Section 2722 of the Public Health Service 
     Act (42 U.S.C. 300gg-22) is amended by adding at the end the 
     following:
       ``(c) Violation of Genetic Discrimination or Genetic 
     Disclosure Provisions.--In any action under this section 
     against any administrator of a group health plan, or health 
     insurance issuer offering group health insurance coverage in 
     connection with a group health plan (including any third 
     party administrator or other person acting for or on behalf 
     of such plan or issuer) alleging a violation of subsections 
     (a)(1)(F), (b) (with respect to cases relating to genetic 
     information or information about a request or receipt of 
     genetic services by an individual or family member of such 
     individual), (c), (d), (e), (f), or (g) of section 2702 and 
     section 2707 the court may award any appropriate legal or 
     equitable relief. Such relief may include a requirement for 
     the payment of attorney's fees and costs, including the costs 
     of expert witnesses.
       ``(d) Civil Penalty.--The monetary provisions of section 
     308(b)(2)(C) of Public Law 101-336 (42 U.S.C. 12188(b)) shall 
     apply for purposes of the Secretary enforcing the provisions 
     referred to in subsection (c), except that any such relief 
     awarded shall be paid only into the general fund of the 
     Treasury.''.
       (2) Individual plans.--Section 2761 of the Public Health 
     Service Act (42 U.S.C. 300gg-45) is amended by adding at the 
     end the following:

[[Page 13021]]

       ``(c) Violation of Genetic Discrimination or Genetic 
     Disclosure Provisions.--In any action under this section 
     against any health insurance issuer offering health insurance 
     coverage in the individual market (including any other person 
     acting for or on behalf of such issuer) alleging a violation 
     of section 2753 and 2754 the court in which the action is 
     commenced may award any appropriate legal or equitable 
     relief. Such relief may include a requirement for the payment 
     of attorney's fees and costs, including the costs of expert 
     witnesses.
       ``(d) Civil Penalty.--The monetary provisions of section 
     308(b)(2)(C) of Public Law 101-336 (42 U.S.C. 12188(b)) shall 
     apply for purposes of the Secretary enforcing the provisions 
     referred to in subsection (c), except that any such relief 
     awarded shall be paid only into the general fund of the 
     Treasury.''.
       (d) Preemption.--
       (1) Group market.--Section 2723 of the Public Health 
     Service Act (42 U.S.C. 300gg-23) is amended--
       (A) in subsection (a)(1), by inserting ``or (e)'' after 
     ``subsection (b)''; and
       (B) by adding at the end the following:
       ``(e) Special Rule in Case of Genetic Information.--With 
     respect to group health insurance coverage offered by a 
     health insurance issuer, the provisions of this part relating 
     to genetic information (including information about a request 
     for or the receipt of genetic services by an individual or a 
     family member of such individual) shall not be construed to 
     supersede any provision of State law which establishes, 
     implements, or continues in effect a standard, requirement, 
     or remedy that more completely--
       ``(1) protects the confidentiality of genetic information 
     (including information about a request for or the receipt of 
     genetic services by an individual or a family member of such 
     individual) or the privacy of an individual or a family 
     member of the individual with respect to genetic information 
     (including information about a request for or the receipt of 
     genetic services by an individual or a family member of such 
     individual); or
       ``(2) prohibits discrimination on the basis of genetic 
     information than does this part.''.
       (2) Individual market.--Section 2762 of the Public Health 
     Service Act (42 U.S.C. 300gg-46) is amended--
       (A) in subsection (a), by inserting ``and except as 
     provided in subsection (c),'' after ``Subject to subsection 
     (b),''; and
       (B) by adding at the end the following:
       ``(c) Special Rule in Case of Genetic Information.--With 
     respect to individual health insurance coverage offered by a 
     health insurance issuer, the provisions of this part (or part 
     C insofar as it applies to this part) relating to genetic 
     information (including information about a request for or the 
     receipt of genetic services by an individual or a family 
     member of such individual) shall not be construed to 
     supersede any provision of State law (as defined in section 
     2723(d)) which establishes, implements, or continues in 
     effect a standard, requirement, or remedy that more 
     completely--
       ``(1) protects the confidentiality of genetic information 
     (including information about a request for or the receipt of 
     genetic services of an individual or a family member of such 
     individual) or the privacy of an individual or a family 
     member of the individual with respect to genetic information 
     (including information about a request for or the receipt of 
     genetic services by an individual or a family member of such 
     individual) than does this part (or part C insofar as it 
     applies to this part); or
       ``(2) prohibits discrimination on the basis of genetic 
     information than does this part (or part C insofar as it 
     applies to this part).''.
       (e) Elimination of Option of Non-Federal Governmental Plans 
     To Be Excepted From Requirements Concerning Genetic 
     Information.--Section 2721(b)(2) of the Public Health Service 
     Act (42 U.S. C. 300gg-21(b)(2)) is amended--
       (1) in subparagraph (A), by striking ``If the plan 
     sponsor'' and inserting ``Except as provided in subparagraph 
     (D), if the plan sponsor''; and
       (2) by adding at the end the following:
       ``(D) Election not applicable to requirements concerning 
     genetic information.--The election described in subparagraph 
     (A) shall not be available with respect to the provisions of 
     subsections (a)(1)(F), (c), (d), (e), (f), and (g) of section 
     2702 and section 2707, and the provisions of section 2702(b) 
     to the extent that they apply to genetic information (or 
     information about a request for or the receipt of genetic 
     services by an individual or a family member of such 
     individual).''.
       (f) Amendment Concerning Supplemental Excepted Benefits.--
       (1) Group market.--Section 2721(d)(3) of the Public Health 
     Service Act (42 U.S.C. 300gg-23(d)(3)) is amended by 
     inserting ``, other than the requirements of subsections 
     (a)(1)(F), (b) (in cases relating to genetic information or 
     information about a request for or the receipt of genetic 
     services by an individual or a family member of such 
     individual)), (c), (d), (e), (f) and (g) of section 2702 and 
     section 2707,'' after ``The requirements of this part''.
       (2) Individual market.--Section 2763(b) of the Public 
     Health Service Act (42 U.S.C. 300gg-47(b)) is amended--
       (A) by striking ``The requirements of this part'' and 
     inserting the following:
       ``(1) In general.--Except as provided in paragraph (2), the 
     requirements of this part''; and
       (B) by adding at the end the following:
       ``(2) Limitation.--The requirements of sections 2753 and 
     2754 shall apply to excepted benefits described in section 
     2791(c)(4).''.
       (g) Effective Date.--
       (1) In general.--The amendments made by this section shall 
     apply with respect to--
       (A) group health plans, and health insurance coverage 
     offered in connection with group health plans, for plan years 
     beginning; and
       (B) health insurance coverage offered, sold, issued, 
     renewed, in effect, or operated in the individual market, 
     after July 1, 2000.
       (2) Special rule for collective bargaining agreements.--In 
     the case of a group health plan maintained pursuant to one or 
     more collective bargaining agreements between employee 
     representatives and one or more employers ratified before the 
     date of the enactment of this Act, the amendments made by 
     this section shall not apply to plan years beginning before 
     the later of--
       (A) the date on which the last of the collective bargaining 
     agreements relating to the plan terminates (determined 
     without regard to any extension thereof agreed to after the 
     date of the enactment of this Act); or

       (B) July 1, 2001.

     For purposes of subparagraph (A), any plan amendment made 
     pursuant to a collective bargaining agreement relating to the 
     plan which amends the plan solely to conform to any 
     requirement of the amendments made by this section shall not 
     be treated as a termination of such collective bargaining 
     agreement.

     SEC. __12. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY 
                   ACT OF 1974.

       (a) Prohibition of Health Insurance Discrimination on the 
     Basis of Genetic Services or Predictive Genetic 
     Information.--Subpart B of Part 7 of subtitle B of title I of 
     the Employee Retirement Income Security Act of 1974 (29 
     U.S.C. 1185 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 714. PROHIBITING DISCRIMINATION AGAINST GROUPS ON THE 
                   BASIS OF PREDICTIVE GENETIC INFORMATION.

       ``Each group health plan, and health insurance issuer 
     offering group health insurance coverage in connection with a 
     group health plan, shall comply with the genetic 
     nondiscrimination provisions of subsections (a)(1)(F) and (c) 
     through (g) of section 2702, and section 2707 of the Public 
     Health Service Act, and each health insurance issuer shall 
     comply with such provisions with respect to group health 
     insurance coverage it offers, and such provisions shall be 
     deemed to be incorporated into this subsection.''.
       (b) Enforcement.--Section 502 (29 U.S.C. 1132) is amended 
     by adding at the end the following:
       ``(n) Violation of Genetic Discrimination or Genetic 
     Disclosure Provisions.--In any action under this section 
     against any administrator of a group health plan, or health 
     insurance issuer offering group health insurance coverage in 
     connection with a group health plan (including any third 
     party administrator or other person acting for or on behalf 
     of such plan or issuer) alleging a violation of section 714, 
     the court may award any appropriate legal or equitable 
     relief. Such relief may include a requirement for the payment 
     of attorney's fees and costs, including the costs of expert 
     witnesses.
       ``(o) Civil Penalty.--The monetary provisions of section 
     308(b)(2)(C) of Public Law 101-336 (42 U.S.C. 12188(b)) shall 
     apply for purposes of the Secretary enforcing the provisions 
     referred to in subsection (n), except that any such relief 
     awarded shall be paid only into the general fund of the 
     Treasury.''.
       (c) Preemption.--Section 731 of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1191) is amended--
       (1) in subsection (a)(1), by inserting ``or (e)'' after 
     ``subsection (b)''; and
       (2) by adding at the end the following:
       ``(e) Special Rule in Case of Genetic Information.--With 
     respect to group health insurance coverage offered by a 
     health insurance issuer, the provisions of this part relating 
     to genetic information (including information about a request 
     for or the receipt of genetic services by an individual or a 
     family member of such individual) shall not be construed to 
     supersede any provision of State law which establishes, 
     implements, or continues in effect a standard, requirement, 
     or remedy that more completely--
       ``(1) protects the confidentiality of genetic information 
     (including information about a request for or the receipt of 
     genetic services by an individual or a family member of such 
     individual) or the privacy of an individual or a family 
     member of the individual with respect to genetic information 
     (including information about a request for or the receipt of 
     genetic services by an individual or a family member of such 
     individual) than does this part; or
       ``(2) prohibits discrimination on the basis of genetic 
     information than does this part.''.
       (d) Definitions.--Section 733(d) of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1191b(d)) is amended 
     by adding at the end the following:

[[Page 13022]]

       ``(5) Family member.--The term `family member' means with 
     respect to an individual--
       ``(A) the spouse of the individual;
       ``(B) a dependent child of the individual, including a 
     child who is born to or placed for adoption with the 
     individual; and
       ``(C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       ``(6) Genetic information.--The term `genetic information' 
     means information about genes, gene products, or inherited 
     characteristics that may derive from an individual or a 
     family member of such individual (including information about 
     a request for or the receipt of genetic services by such 
     individual or family member of such individual).
       ``(7) Genetic services.--The term `genetic services' means 
     health services, including genetic tests, provided to obtain, 
     assess, or interpret genetic information for diagnostic and 
     therapeutic purposes, and for genetic education and 
     counseling.
       ``(8) Genetic test.--The term `genetic test' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites in order to detect genotypes, mutations, 
     or chromosomal changes.
       ``(9) Predictive genetic information.--
       ``(A) In general.--The term `predictive genetic 
     information' means--
       ``(i) information about an individual's genetic tests;
       ``(ii) information about genetic tests of family members of 
     the individual; or
       ``(iii) information about the occurrence of a disease or 
     disorder in family members.
       ``(B) Limitations.--The term `predictive genetic 
     information' shall not include--
       ``(i) information about the sex or age of the individual;
       ``(ii) information about chemical, blood, or urine analyses 
     of the individual, unless these analyses are genetic tests; 
     or
       ``(iii) information about physical exams of the individual, 
     and other information relevant to determining the current 
     health status of the individual.''.
       (e) Amendment Concerning Supplemental Excepted Benefits.--
     Section 732(c)(3) of the Employee Retirement Income Security 
     Act of 1974 (29 U.S.C. 1191a(c)(3)) is amended by inserting 
     ``, other than the requirements of section 714,'' after ``The 
     requirements of this part''.
       (f) Effective Date.--
       (1) In general.--Except as provided in this section, this 
     section and the amendments made by this section shall apply 
     with respect to group health plans for plan years beginning 
     after July 1, 2001.
       (2) Special rule for collective bargaining agreements.--In 
     the case of a group health plan maintained pursuant to one or 
     more collective bargaining agreements between employee 
     representatives and one or more employers ratified before the 
     date of the enactment of this Act, this section and the 
     amendments made by this section shall not apply to plan years 
     beginning before the later of--
       (A) the date on which the last of the collective bargaining 
     agreements relating to the plan terminates (determined 
     without regard to any extension thereof agreed to after the 
     date of the enactment of this Act), or
       (B) July 1, 2001.

     For purposes of subparagraph (A), any plan amendment made 
     pursuant to a collective bargaining agreement relating to the 
     plan which amends the plan solely to conform to any 
     requirement of the amendments made by this section shall not 
     be treated as a termination of such collective bargaining 
     agreement.

     SEC. __13. AMENDMENTS TO INTERNAL REVENUE CODE OF 1986.

       (a) Prohibition of Health Insurance Discrimination on the 
     Basis of Genetic Services or Predictive Genetic 
     Information.--Subchapter B of chapter 100 of the Internal 
     Revenue Code of 1986 is amended by adding at the end the 
     following:

     ``SEC. 9813. PROHIBITING DISCRIMINATION ON THE BASIS OF 
                   PREDICTIVE GENETIC INFORMATION.

       ``(a) In General.--Each group health plan shall comply with 
     the genetic nondiscrimination provisions of subsections 
     (a)(1)(F) and (c) through (i) of section 2702, and section 
     2707 of the Public Health Service Act and such provisions 
     shall be deemed to be incorporated into this subsection.
       ``(b) Violation of Genetic Discrimination or Genetic 
     Disclosure Provisions.--In any action under this section 
     against any administrator of a group health plan (including 
     any third party administrator or other person acting for or 
     on behalf of such plan) alleging a violation of subsection 
     (a), the court may award any appropriate legal or equitable 
     relief. Such relief may include a requirement for the payment 
     of attorney's fees and costs, including the costs of expert 
     witnesses.
       ``(c) Civil Penalty.--The monetary provisions of section 
     308(b)(2)(C) of Public Law 101-336 (42 U.S.C. 12188(b)) shall 
     apply for purposes of the Secretary enforcing the provisions 
     referred to in subsection (b), except that any such relief 
     awarded shall be paid only into the general fund of the 
     Treasury.''.
       (b) Effective Date.--
       (1) In general.--Except as provided in this section, this 
     section and the amendments made by this section shall apply 
     with respect to group health plans for plan years beginning 
     after July 1, 2001.
       (2) Special rule for collective bargaining agreements.--In 
     the case of a group health plan maintained pursuant to one or 
     more collective bargaining agreements between employee 
     representatives and one or more employers ratified before the 
     date of the enactment of this Act, this section and the 
     amendments made by this section shall not apply to plan years 
     beginning before the later of--
       (A) the date on which the last of the collective bargaining 
     agreements relating to the plan terminates (determined 
     without regard to any extension thereof agreed to after the 
     date of the enactment of this Act), or
       (B) July 1, 2001.
     For purposes of subparagraph (A), any plan amendment made 
     pursuant to a collective bargaining agreement relating to the 
     plan which amends the plan solely to conform to any 
     requirement of the amendments made by this section shall not 
     be treated as a termination of such collective bargaining 
     agreement.

 Subtitle B--Prohibition of Employment Discrimination on the Basis of 
                     Predictive Genetic Information

     SEC. __21. DEFINITIONS.

       In this subtitle:
       (1) Employee; employer; employment agency; labor 
     organization; member.--The terms ``employee'', ``employer'', 
     ``employment agency'', and ``labor organization'' have the 
     meanings given such terms in section 701 of the Civil Rights 
     Act of 1964 (42 U.S.C. 2000e), except that the terms 
     ``employee'' and ``employer'' shall also include the meanings 
     given such terms in section 717 of the Civil Rights Act of 
     1964 (42 U.S.C. 2000e-16). The terms ``employee'' and 
     ``member'' include an applicant for employment and an 
     applicant for membership in a labor organization, 
     respectively.
       (2) Family member.--The term ``family member'' means with 
     respect to an individual--
       (A) the spouse of the individual;
       (B) a dependent child of the individual, including a child 
     who is born to or placed for adoption with the individual; 
     and
       (C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       (3) Genetic monitoring.--The term ``genetic monitoring'' 
     means the periodic examination of employees to evaluate 
     acquired modifications to their genetic material, such as 
     chromosomal damage or evidence of increased occurrence of 
     mutations, that may have developed in the course of 
     employment due to exposure to toxic substances in the 
     workplace, in order to identify, evaluate, and respond to the 
     effects of or control adverse environmental exposures in the 
     workplace.
       (4) Genetic services.--The term ``genetic services'' means 
     health services, including genetic tests, provided to obtain, 
     assess, or interpret genetic information for diagnostic and 
     therapeutic purposes, and for genetic education and 
     counseling.
       (5) Genetic test.--The term ``genetic test'' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites in order to detect genotypes, mutations, 
     or chromosomal changes.
       (6) Predictive genetic information.--
       (A) In general.--The term ``predictive genetic 
     information'' means--
       (i) information about an individual's genetic tests;
       (ii) information about genetic tests of family members of 
     the individual; or
       (iii) information about the occurrence of a disease or 
     disorder in family members.
       (B) Limitations.--The term ``predictive genetic 
     information'' shall not include--
       (i) information about the sex or age of the individual;
       (ii) information about chemical, blood, or urine analyses 
     of the individual, unless these analyses are genetic tests; 
     or
       (iii) information about physical exams of the individual, 
     and other information relevant to determining the current 
     health status of the individual.

     SEC. __22. EMPLOYER PRACTICES.

       (a) In General.--It shall be an unlawful employment 
     practice for an employer--
       (1) to fail or refuse to hire or to discharge any 
     individual, or otherwise to discriminate against any 
     individual with respect to the compensation, terms, 
     conditions, or privileges of employment of the individual, 
     because of predictive genetic information with respect to the 
     individual (or information about a request for or the receipt 
     of genetic services by such individual or family member of 
     such individual;
       (2) to limit, segregate, or classify the employees of the 
     employer in any way that would deprive or tend to deprive any 
     individual of employment opportunities or otherwise adversely 
     affect the status of the individual as an employee, because 
     of predictive genetic information with respect to the 
     individual, or information about a request for or the receipt 
     of genetic services by such individual or family member of 
     such individual; or
       (3) to request, require, collect or purchase predictive 
     genetic information with respect to an individual or a family 
     member of the individual except--

[[Page 13023]]

       (A) where used for genetic monitoring of biological effects 
     of toxic substances in the workplace, but only if--
       (i) the employee has provided prior, knowing, voluntary, 
     and written authorization;
       (ii) the employee is informed of individual monitoring 
     results;
       (iii) the monitoring conforms to any genetic monitoring 
     regulations that may be promulgated by the Secretary of Labor 
     pursuant to the Occupational Safety and Health Act of 1970 
     (29 U.S.C. 651 et seq.) or the Federal Mine Safety and Health 
     Act of 1977 (30 U.S.C. 801 et seq.); and
       (iv) the employer, excluding any licensed health care 
     professional that is involved in the genetic monitoring 
     program, receives the results of the monitoring only in 
     aggregate terms that do not disclose the identity of specific 
     employees; or
       (B) where genetic services are offered by the employer and 
     the employee provides prior, knowing, voluntary, and written 
     authorization, and only the employee or family member of such 
     employee receives the results of such services.
       (b) Limitation.--In the case of predictive genetic 
     information to which subparagraph (A) or (B) of subsection 
     (a)(3) applies, such information may not be used in violation 
     of paragraph (1) or (2) of subsection (a).

     SEC. __23. EMPLOYMENT AGENCY PRACTICES.

       It shall be an unlawful employment practice for an 
     employment agency--
       (1) to fail or refuse to refer for employment, or otherwise 
     to discriminate against, any individual because of predictive 
     genetic information with respect to the individual (or 
     information about a request for or the receipt of genetic 
     services by such individual or family member of such 
     individual);
       (2) to limit, segregate, or classify individuals or fail or 
     refuse to refer for employment any individual in any way that 
     would deprive or tend to deprive any individual of employment 
     opportunities or would limit the employment opportunities or 
     otherwise adversely affect the status of the individual as an 
     employee, because of predictive genetic information with 
     respect to the individual (or information about a request for 
     or the receipt of genetic services by such individual or 
     family member of such individual);
       (3) to request, require, collect or purchase predictive 
     genetic information with respect to an individual (or 
     information about a request for or the receipt of genetic 
     services by such individual or family member of such 
     individual); or
       (4) to cause or attempt to cause an employer to 
     discriminate against an individual in violation of this 
     subtitle.

     SEC. __24. LABOR ORGANIZATION PRACTICES.

       It shall be an unlawful employment practice for a labor 
     organization--
       (1) to exclude or to expel from the membership of the 
     organization, or otherwise to discriminate against, any 
     individual because of predictive genetic information with 
     respect to the individual (or information about a request for 
     or the receipt of genetic services by such individual or 
     family member of such individual);
       (2) to limit, segregate, or classify the members of the 
     organization, or fail or refuse to refer for employment any 
     individual, in any way that would deprive or tend to deprive 
     any individual of employment opportunities, or would limit 
     the employment opportunities or otherwise adversely affect 
     the status of the individual as an employee, because of 
     predictive genetic information with respect to the individual 
     (or information about a request for or the receipt of genetic 
     services by such individual or family member of such 
     individual);
       (3) to request, require, collect or purchase predictive 
     genetic information with respect to an individual (or 
     information about a request for or the receipt of genetic 
     services by such individual or family member of such 
     individual); or
       (4) to cause or attempt to cause an employer to 
     discriminate against an individual in violation of this 
     subtitle.

     SEC. __25. TRAINING PROGRAMS.

       It shall be an unlawful employment practice for any 
     employer, labor organization, or joint labor-management 
     committee controlling apprenticeship or other training or 
     retraining, including on-the-job training programs--
       (1) to discriminate against any individual because of 
     predictive genetic information with respect to the individual 
     (or information about a request for or the receipt of genetic 
     services by such individual), in admission to, or employment 
     in, any program established to provide apprenticeship or 
     other training or retraining;
       (2) to limit, segregate, or classify the members of the 
     organization, or fail or refuse to refer for employment any 
     individual, in any way that would deprive or tend to deprive 
     any individual of employment opportunities, or would limit 
     the employment opportunities or otherwise adversely affect 
     the status of the individual as an employee, because of 
     predictive genetic information with respect to the individual 
     (or information about a request for or receipt of genetic 
     services by such individual or family member of such 
     individual);
       (3) to request, require, collect or purchase predictive 
     genetic information with respect to an individual (or 
     information about a request for or receipt of genetic 
     services by such individual or family member of such 
     individual); or
       (4) to cause or attempt to cause an employer to 
     discriminate against an individual in violation of this 
     subtitle.

     SEC. __26. MAINTENANCE AND DISCLOSURE OF PREDICTIVE GENETIC 
                   INFORMATION.

       (a) Maintenance of Predictive Genetic Information.--If an 
     employer possesses predictive genetic information about an 
     employee (or information about a request for or receipt of 
     genetic services by such employee or family member of such 
     employee), such information shall be treated or maintained as 
     part of the employee's confidential medical records.
       (b) Disclosure of Predictive Genetic Information.--An 
     employer shall not disclose predictive genetic information 
     (or information about a request for or receipt of genetic 
     services by such employee or family member of such employee) 
     except--
       (1) to the employee who is the subject of the information 
     at the request of the employee;
       (2) to an occupational or other health researcher if the 
     research is conducted in compliance with the regulations and 
     protections provided for under part 46 of title 45, Code of 
     Federal Regulations;
       (3) under legal compulsion of a Federal court order, except 
     that if the court order was secured without the knowledge of 
     the individual to whom the information refers, the employer 
     shall provide the individual with adequate notice to 
     challenge the court order unless the court order also imposes 
     confidentiality requirements; and
       (4) to government officials who are investigating 
     compliance with this subtitle if the information is relevant 
     to the investigation.

     SEC. __27. CIVIL ACTION.

       (a) In General.--One or more employees, members of a labor 
     organization, or participants in training programs may bring 
     an action in a Federal or State court of competent 
     jurisdiction against an employer, employment agency, labor 
     organization, or joint labor-management committee or training 
     program who commits a violation of this subtitle.
       (b) Enforcement by the Equal Employment Opportunity 
     Commission.--
       (1) In general.--The powers, remedies, and procedures set 
     forth in sections 705, 706, 707, 709, 710, and 717 of the 
     Civil Rights Act of 1964 (42 U.S.C. 2000e-4, 2000e-5, 2000e-
     6, 2000e-8, 2000e-9, and 2000e-16) shall be the powers, 
     remedies, and procedures provided to the Equal Employment 
     Opportunity Commission to enforce this subtitle. The 
     Commission may promulgate regulations to implement these 
     powers, remedies, and procedures.
       (2) Exhaustion of remedies.--Nothing in this subsection 
     shall be construed to require that an individual exhaust the 
     administrative remedies available through the Equal 
     Employment Opportunity Commission prior to commencing a civil 
     action under this section, except that if an individual files 
     a charge of discrimination with the Commission that alleges a 
     violation of this subtitle, the individual shall exhaust the 
     administrative remedies available through the Commission 
     prior to commencing a civil action under this section.
       (c) Remedy.--A Federal or State court may award any 
     appropriate legal or equitable relief under this section. 
     Such relief may include a requirement for the payment of 
     attorney's fees and costs, including the costs of experts.

     SEC. __28. CONSTRUCTION.

       Nothing in this subtitle shall be construed to--
       (1) limit the rights or protections of an individual under 
     the Americans with Disabilities Act of 1990 (42 U.S.C. 12101 
     et seq.), including coverage afforded to individuals under 
     section 102 of such Act;
       (2) limit the rights or protections of an individual under 
     the Rehabilitation Act of 1973 (29 U.S.C. 701 et seq.);
       (3) limit the rights or protections of an individual under 
     any other Federal or State statute that provides equal or 
     greater protection to an individual than the rights accorded 
     under this subtitle;
       (4) apply to the Armed Forces Repository of Specimen 
     Samples for the Identification of Remains; or
       (5) limit the statutory or regulatory authority of the 
     Occupational Safety and Health Administration or the Mine 
     Safety and Health Administration to promulgate or enforce 
     workplace safety and health laws and regulations.

     SEC. __29. AUTHORIZATION OF APPROPRIATIONS.

       There are authorized to be appropriated such sums as may be 
     necessary to carry out this subtitle.

     SEC. __30. EFFECTIVE DATE.

       This subtitle shall become effective on October 1, 2000.
       Sec.  31. No Impact on Social Security Trust Fund.--
       (1) In general.--Nothing in this title shall be construed 
     to alter or amend the Social Security Act (or any regulation 
     promulgated under that Act).
       (2) Transfers.--
       (A) Estimate of secretary.--The Secretary of the Treasury 
     shall annually estimate the impact that the enactment of this

[[Page 13024]]

     title has on the income and balances of the trust funds 
     established under section 201 of the Social Security Act (42 
     U.S.C. 401).
       (B) Transfer of funds.--If, under subparagraph (A), the 
     Secretary of the Treasury estimates that the enactment of 
     this title has a negative impact on the income and balances 
     of the trust funds established under section 201 of the 
     Social Security Act (42 U.S.C. 401), the Secretary shall 
     transfer, not less frequently than quarterly, from the 
     general revenues of the Federal Government an amount 
     sufficient so as to ensure that the income and balances of 
     such trust funds are not reduced as a result of the enactment 
     of such title.
       Sec.  32. Information Requirements.--
       (1) Information from group health plans.--Section 1862(b) 
     of the Social Security Act (42 U.S.C. 1395y(b)) is amended by 
     adding at the end the following:
       ``(7) Information from group health plans.--
       ``(A) Provision of information by group health plans.--The 
     administrator of a group health plan subject to the 
     requirements of paragraph (1) shall provide to the Secretary 
     such of the information elements described in subparagraph 
     (C) as the Secretary specifies, and in such manner and at 
     such times as the Secretary may specify (but not more 
     frequently than 4 times per year), with respect to each 
     individual covered under the plan who is entitled to any 
     benefits under this title.
       ``(B) Provision of information by employers and employee 
     organizations.--An employer (or employee organization) that 
     maintains or participates in a group health plan subject to 
     the requirements of paragraph (1) shall provide to the 
     administrator of the plan such of the information elements 
     required to be provided under subparagraph (A), and in such 
     manner and at such times as the Secretary may specify, at a 
     frequency consistent with that required under subparagraph 
     (A) with respect to each individual described in subparagraph 
     (A) who is covered under the plan by reason of employment 
     with that employer or membership in the organization.
       ``(C) Information elements.--The information elements 
     described in this subparagraph are the following:
       ``(i) Elements concerning the individual.--

       ``(I) The individual's name.
       ``(II) The individual's date of birth.
       ``(III) The individual's sex.
       ``(IV) The individual's social security insurance number.
       ``(V) The number assigned by the Secretary to the 
     individual for claims under this title.
       ``(VI) The family relationship of the individual to the 
     person who has or had current or employment status with the 
     employer.

       ``(ii) Elements concerning the family member with current 
     or former employment status.--

       ``(I) The name of the person in the individual's family who 
     has current or former employment status with the employer.
       ``(II) That person's social security insurance number.
       ``(III) The number or other identifier assigned by the plan 
     to that person.
       ``(IV) The periods of coverage for that person under the 
     plan.

       ``(V) The employment status of that person (current or 
     former) during those periods of coverage.
       ``(VI) The classes (of that person's family members) 
     covered under the plan.

       ``(iii) Plan elements.--

       ``(I) The items and services covered under the plan.
       ``(II) The name and address to which claims under the plan 
     are to be sent.

       ``(iv) Elements concerning the employer.--

       ``(I) The employer's name.
       ``(II) The employer's address.
       ``(III) The employer identification number of the employer.

       ``(D) Use of identifiers.--The administrator of a group 
     health plan shall utilize a unique identifier for the plan in 
     providing information under subparagraph (A) and in other 
     transactions, as may be specified by the Secretary, related 
     to the provisions of this subsection. The Secretary may 
     provide to the administrator the unique identifier described 
     in the preceding sentence.
       ``(E) Penalty for noncompliance.--Any entity that knowingly 
     and willfully fails to comply with a requirement imposed by 
     the previous subparagraphs shall be subject to a civil money 
     penalty not to exceed $1,000 for each incident of such 
     failure. The provisions of section 1128A (other than 
     subsections (a) and (b)) shall apply to a civil money penalty 
     under the previous sentence in the same manner as those 
     provisions apply to a penalty or proceeding under section 
     1128A(a).''.
       (2) Effective date.--The amendment made by paragraph (1) 
     shall take effect 180 days after the date of the enactment of 
     this Act.
       Sec.  33. Offset.--Amounts made available under this Act 
     for the administrative and related expenses for departmental 
     management for the Department of Labor and the Department of 
     Health and Human Services shall be reduced on a pro rata 
     basis by $25,000,000.
                                 ______
                                 

                ASHCROFT (AND OTHERS) AMENDMENT NO. 3689

  Mr. ASHCROFT (for himself, Mr. Voinovich, Mr. Allard, Mr. Grams, Mr. 
Abraham, and Mr. Feingold) proposed an amendment to the bill, H.R. 
4577, supra; as follows:

       At the end, insert the following:

     SEC. __. SOCIAL SECURITY AND MEDICARE SAFE DEPOSIT BOX ACT OF 
                   2000.

       (a) Short Title.--This section may be cited as the ``Social 
     Security and Medicare Safe Deposit Box Act of 2000''.
       (b) Protection of Social Security and Medicare Surpluses.--
       (1) Medicare surpluses off-budget.--Notwithstanding any 
     other provision of law, the net surplus of any trust fund for 
     part A of Medicare shall not be counted as a net surplus for 
     purposes of--
       (A) the budget of the United States Government as submitted 
     by the President;
       (B) the congressional budget; or
       (C) the Balanced Budget and Emergency Deficit Control Act 
     of 1985.
       (2) Points of order to protect social security and medicare 
     surpluses.--Section 312 of the Congressional Budget Act of 
     1974 is amended by adding at the end the following new 
     subsection:
       ``(g) Points of Order To Protect Social Security and 
     Medicare Surpluses.--
       ``(1) Concurrent resolutions on the budget.--It shall not 
     be in order in the House of Representatives or the Senate to 
     consider any concurrent resolution on the budget, or 
     conference report thereon or amendment thereto, that would 
     set forth an on-budget deficit for any fiscal year.
       ``(2) Subsequent legislation.--It shall not be in order in 
     the House of Representatives or the Senate to consider any 
     bill, joint resolution, amendment, motion, or conference 
     report if--
       ``(A) the enactment of that bill or resolution as reported;
       ``(B) the adoption and enactment of that amendment; or
       ``(C) the enactment of that bill or resolution in the form 
     recommended in that conference report,
     would cause or increase an on-budget deficit for any fiscal 
     year.
       ``(3) Definition.--For purposes of this section, the term 
     `on-budget deficit', when applied to a fiscal year, means the 
     deficit in the budget as set forth in the most recently 
     agreed to concurrent resolution on the budget pursuant to 
     section 301(a)(3) for that fiscal year.''.
       (3) Super majority requirement.--
       (A) Point of order.--Section 904(c)(1) of the Congressional 
     Budget Act of 1974 is amended by inserting ``312(g),'' after 
     ``310(d)(2),''.
       (B) Waiver.--Section 904(d)(2) of the Congressional Budget 
     Act of 1974 is amended by inserting ``312(g),'' after 
     ``310(d)(2),''.
       (c) Protection of Social Security and Medicare Surpluses.--
       (1) In general.--Chapter 11 of subtitle II of title 31, 
     United States Code, is amended by adding before section 1101 
     the following:

     ``Sec. 1100. Protection of social security and medicare 
       surpluses

       ``The budget of the United States Government submitted by 
     the President under this chapter shall not recommend an on-
     budget deficit for any fiscal year covered by that budget.''.
       (2) Chapter analysis.--The chapter analysis for chapter 11 
     of title 31, United States Code, is amended by inserting 
     before the item for section 1101 the following:

``1100. Protection of social security and medicare surpluses.''.

       (d) Effective Date.--This section shall take effect upon 
     the date of its enactment and the amendments made by this 
     section shall apply to fiscal year 2001 and subsequent fiscal 
     years.
                                 ______
                                 

               CONRAD (AND LAUTENBERG) AMENDMENT NO. 3690

  Mr. REID (for Mr. Conrad (for himself, Mr. Lautenberg, and Mr. 
Feingold)) proposed an amendment to the bill, H.R. 4577, supra; as 
follows:

       Strike all after the first word and insert the following:
 TITLE __--SOCIAL SECURITY AND MEDICARE OFF-BUDGET LOCKBOX ACT OF 2000

     SEC. __1. SHORT TITLE.

       This title may be cited as the ``Social Security and 
     Medicare Off-Budget Lockbox Act of 2000''.

     SEC. __2. STRENGTHENING SOCIAL SECURITY POINTS OF ORDER.

       (a) In General.--Section 312 of the Congressional Budget 
     Act of 1974 (2 U.S.C. 643) is amended by inserting at the end 
     the following:
       ``(g) Strengthening Social Security Point of Order.--It 
     shall not be in order in the House of Representatives or the 
     Senate to consider a concurrent resolution on the budget (or 
     any amendment thereto or conference report thereon) or any 
     bill, joint resolution, amendment, motion, or conference 
     report that would violate or amend section 13301 of the 
     Budget Enforcement Act of 1990.''.

[[Page 13025]]

       (b) Super Majority Requirement.--
       (1) Point of order.--Section 904(c)(1) of the Congressional 
     Budget Act of 1974 is amended by inserting ``312(g),'' after 
     ``310(d)(2),''.
       (2) Waiver.--Section 904(d)(2) of the Congressional Budget 
     Act of 1974 is amended by inserting ``312(g),'' after 
     ``310(d)(2),''.
       (c) Enforcement in Each Fiscal Year.--The Congressional 
     Budget Act of 1974 is amended in--
       (1) section 301(a)(7) (2 U.S.C. 632(a)(7)), by striking 
     ``for the fiscal year'' through the period and inserting 
     ``for each fiscal year covered by the resolution''; and
       (2) section 311(a)(3) (2 U.S.C. 642(a)(3)), by striking 
     beginning with ``for the first fiscal year'' through the 
     period and insert the following: ``for any of the fiscal 
     years covered by the concurrent resolution.''.

     SEC. __3. MEDICARE TRUST FUND OFF-BUDGET.

       (a) In General.--
       (1) General exclusion from all budgets.--Title III of the 
     Congressional Budget Act of 1974 is amended by adding at the 
     end the following:


          ``exclusion of medicare trust fund from all budgets

       ``Sec. 316. (a) Exclusion of Medicare Trust Fund From All 
     Budgets.--Notwithstanding any other provision of law, the 
     receipts and disbursements of the Federal Hospital Insurance 
     Trust Fund shall not be counted as new budget authority, 
     outlays, receipts, or deficit or surplus for purposes of--
       ``(1) the budget of the United States Government as 
     submitted by the President;
       ``(2) the congressional budget; or
       ``(3) the Balanced Budget and Emergency Deficit Control Act 
     of 1985.
       ``(b) Strengthening Medicare Point of Order.--It shall not 
     be in order in the House of Representatives or the Senate to 
     consider a concurrent resolution on the budget (or any 
     amendment thereto or conference report thereon) or any bill, 
     joint resolution, amendment, motion, or conference report 
     that would violate or amend this section.''.
       (2) Super majority requirement.--
       (A) Point of Order.--Section 904(c)(1) of the Congressional 
     Budget Act of 1974 is amended by inserting ``316,'' after 
     ``313,''.
       (B) Waiver.--Section 904(d)(2) of the Congressional Budget 
     Act of 1974 is amended by inserting ``316,'' after ``313,''.
       (b) Exclusion of Medicare Trust Fund From Congressional 
     Budget.--Section 301(a) of the Congressional Budget Act of 
     1974 (2 U.S.C. 632(a)) is amended by adding at the end the 
     following: ``The concurrent resolution shall not include the 
     outlays and revenue totals of the Federal Hospital Insurance 
     Trust Fund in the surplus or deficit totals required by this 
     subsection or in any other surplus or deficit totals required 
     by this title.''
       (c) Budget Totals.--Section 301(a) of the Congressional 
     Budget Act of 1974 (2 U.S.C. 632(a)) is amended by inserting 
     after paragraph (7) the following:
       ``(8) For purposes of Senate enforcement under this title, 
     revenues and outlays of the Federal Hospital Insurance Trust 
     Fund for each fiscal year covered by the budget 
     resolution.''.
       (d) Budget resolutions.--Section 301(i) of the 
     Congressional Budget Act of 1974 (2 U.S.C. 632(i)) is amended 
     by--
       (1) striking ``Social Security Point of Order.--It shall'' 
     and inserting ``Social Security and Medicare Points of 
     Order.--
       ``(1) Social security.--It shall''; and
       (2) inserting at the end the following:
       ``(2) Medicare.--It shall not be in order in the House of 
     Representatives or the Senate to consider any concurrent 
     resolution on the budget (or amendment, motion, or conference 
     report on the resolution) that would decrease the excess of 
     the Federal Hospital Insurance Trust Fund revenues over 
     Federal Hospital Insurance Trust Fund outlays in any of the 
     fiscal years covered by the concurrent resolution. This 
     paragraph shall not apply to amounts to be expended from the 
     Hospital Insurance Trust Fund for purposes relating to 
     programs within part A of Medicare as provided in law on the 
     date of enactment of this paragraph.''.
       (e) Medicare Firewall.--Section 311(a) of the Congressional 
     Budget Act of 1974 (2 U.S.C. 642(a)) is amended by adding 
     after paragraph (3), the following:
       ``(4) Enforcement of medicare levels in the senate.--After 
     a concurrent resolution on the budget is agreed to, it shall 
     not be in order in the Senate to consider any bill, joint 
     resolution, amendment, motion, or conference report that 
     would cause a decrease in surpluses or an increase in 
     deficits of the Federal Hospital Insurance Trust Fund in any 
     year relative to the levels set forth in the applicable 
     resolution. This paragraph shall not apply to amounts to be 
     expended from the Hospital Insurance Trust Fund for purposes 
     relating to programs within part A of Medicare as provided in 
     law on the date of enactment of this paragraph.''.
       (f) Baseline To Exclude Hospital Insurance Trust Fund.--
     Section 257(b)(3) of the Balanced Budget and Emergency 
     Deficit Control Act of 1985 is amended by striking ``shall be 
     included in all'' and inserting ``shall not be included in 
     any''.
       (g) Medicare Trust Fund Exempt From Sequesters.--Section 
     255(g)(1)(B) of the Balanced Budget and Emergency Deficit 
     Control Act of 1985 is amended by adding at the end the 
     following:
       ``Medicare as funded through the Federal Hospital Insurance 
     Trust Fund.''.
       (h) Budgetary Treatment of Hospital Insurance Trust Fund.--
     Section 710(a) of the Social Security Act (42 U.S.C. 911(a)) 
     is amended--
       (1) by striking ``and'' the second place it appears and 
     inserting a comma; and
       (2) by inserting after ``Federal Disability Insurance Trust 
     Fund'' the following: ``, Federal Hospital Insurance Trust 
     Fund''.

     SEC. __4. PREVENTING ON-BUDGET DEFICITS.

       (a) Points of Order To Prevent On-Budget Deficits.--Section 
     312 of the Congressional Budget Act of 1974 (2 U.S.C. 643) is 
     amended by adding at the end the following:
       ``(h) Points of Order To Prevent On-Budget Deficits.--
       ``(1) Concurrent resolutions on the budget.--It shall not 
     be in order in the House of Representatives or the Senate to 
     consider any concurrent resolution on the budget, or 
     conference report thereon or amendment thereto, that would 
     cause or increase an on-budget deficit for any fiscal year.
       ``(2) Subsequent legislation.--Except as provided by 
     paragraph (3), it shall not be in order in the House of 
     Representatives or the Senate to consider any bill, joint 
     resolution, amendment, motion, or conference report if--
       ``(A) the enactment of that bill or resolution as reported;
       ``(B) the adoption and enactment of that amendment; or
       ``(C) the enactment of that bill or resolution in the form 
     recommended in that conference report,
     would cause or increase an on-budget deficit for any fiscal 
     year.''.
       (b) Super Majority Requirement.--
       (1) Point of order.--Section 904(c)(1) of the Congressional 
     Budget Act of 1974 is amended by inserting ``312(h),'' after 
     ``312(g),''.
       (2) Waiver.--Section 904(d)(2) of the Congressional Budget 
     Act of 1974 is amended by inserting ``312(h),'' after 
     ``312(g),''.
                                 ______
                                 

                JEFFORDS (AND OTHERS) AMENDMENT NO. 3691

  Mr. JEFFORDS (for himself, Mr. Frist, Ms. Snowe, Mr. Ashcroft, Mr. 
Enzi, and Mr. Mack) proposed an amendment to amendment No. 3688 
proposed by Mr. Daschle to the bill, H.R. 4577, supra; as follows:

       At the end of the bill, add the following:

               TITLE __ GENETIC INFORMATION AND SERVICES

     SEC. __01. SHORT TITLE.

       This title may be cited as the ``Genetic Information 
     Nondiscrimination in Health Insurance Act of 1999''.

     SEC. __02. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY 
                   ACT OF 1974.

       (a) Prohibition of Health Discrimination on the Basis of 
     Genetic Information or Genetic Services.--
       (1) No enrollment restriction for genetic services.--
     Section 702(a)(1)(F) of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1182(a)(1)(F)) is amended by 
     inserting before the period the following: ``(including 
     information about a request for or receipt of genetic 
     services)''.
       (2) No discrimination in group premiums based on predictive 
     genetic information.--Subpart B of part 7 of subtitle B of 
     title I of the Employee Retirement Income Security Act of 
     1974 is amended by adding at the end the following:

     ``SEC. 714. PROHIBITING PREMIUM DISCRIMINATION AGAINST GROUPS 
                   ON THE BASIS OF PREDICTIVE GENETIC INFORMATION.

       ``A group health plan, or a health insurance issuer 
     offering group health insurance coverage in connection with a 
     group health plan, shall not adjust premium or contribution 
     amounts for a group on the basis of predictive genetic 
     information concerning any individual (including a dependent) 
     or family member of the individual (including information 
     about a request for or receipt of genetic services).''.
       (3) Conforming amendments.--
       (A) In general.--Section 702(b) of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1182(b)) is amended by 
     adding at the end the following:
       ``(3) Reference to related provision.--For a provision 
     prohibiting the adjustment of premium or contribution amounts 
     for a group under a group health plan on the basis of 
     predictive genetic information (including information about a 
     request for or receipt of genetic services), see section 
     714.''.
       (B) Table of contents.--The table of contents in section 1 
     of the Employee Retirement Income Security Act of 1974 is 
     amended by inserting after the item relating to section 713 
     the following new item:

``Sec. 714. Prohibiting premium discrimination against groups on the 
              basis of predictive genetic information.''.

       (b) Limitation on Collection of Predictive Genetic 
     Information.--Section 702 of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1182) is amended by adding at 
     the end the following:

[[Page 13026]]

       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     group health plan, or a health insurance issuer offering 
     health insurance coverage in connection with a group health 
     plan, shall not request or require predictive genetic 
     information concerning any individual (including a dependent) 
     or family member of the individual (including information 
     about a request for or receipt of genetic services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) In general.--Notwithstanding paragraph (1), a group 
     health plan, or a health insurance issuer offering health 
     insurance coverage in connection with a group health plan, 
     that provides health care items and services to an individual 
     or dependent may request (but may not require) that such 
     individual or dependent disclose, or authorize the collection 
     or disclosure of, predictive genetic information for purposes 
     of diagnosis, treatment, or payment relating to the provision 
     of health care items and services to such individual or 
     dependent.
       ``(B) Notice of confidentiality practices and description 
     of safeguards.--As a part of a request under subparagraph 
     (A), the group health plan, or a health insurance issuer 
     offering health insurance coverage in connection with a group 
     health plan, shall provide to the individual or dependent a 
     description of the procedures in place to safeguard the 
     confidentiality, as described in subsection (d), of such 
     predictive genetic information.
       ``(d) Confidentiality with Respect to Predictive Genetic 
     Information.--
       ``(1) Notice of confidentiality practices.--
       ``(A) Preparation of written notice.--A group health plan, 
     or a health insurance issuer offering health insurance 
     coverage in connection with a group health plan, shall post 
     or provide, in writing and in a clear and conspicuous manner, 
     notice of the plan or issuer's confidentiality practices, 
     that shall include--
       ``(i) a description of an individual's rights with respect 
     to predictive genetic information;
       ``(ii) the procedures established by the plan or issuer for 
     the exercise of the individual's rights; and
       ``(iii) the right to obtain a copy of the notice of the 
     confidentiality practices required under this subsection.
       ``(B) Model notice.--The Secretary, in consultation with 
     the National Committee on Vital and Health Statistics and the 
     National Association of Insurance Commissioners, and after 
     notice and opportunity for public comment, shall develop and 
     disseminate model notices of confidentiality practices. Use 
     of the model notice shall serve as a defense against claims 
     of receiving inappropriate notice.
       ``(2) Establishment of safeguards.--A group health plan, or 
     a health insurance issuer offering health insurance coverage 
     in connection with a group health plan, shall establish and 
     maintain appropriate administrative, technical, and physical 
     safeguards to protect the confidentiality, security, 
     accuracy, and integrity of predictive genetic information 
     created, received, obtained, maintained, used, transmitted, 
     or disposed of by such plan or issuer.''.
       (c) Definitions.--Section 733(d) of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1191b(d)) is amended 
     by adding at the end the following:
       ``(5) Family member.--The term `family member' means with 
     respect to an individual--
       ``(A) the spouse of the individual;
       ``(B) a dependent child of the individual, including a 
     child who is born to or placed for adoption with the 
     individual; and
       ``(C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       ``(6) Genetic information.--The term `genetic information' 
     means information about genes, gene products, or inherited 
     characteristics that may derive from an individual or a 
     family member (including information about a request for or 
     receipt of genetic services).
       ``(7) Genetic services.--The term `genetic services' means 
     health services provided to obtain, assess, or interpret 
     genetic information for diagnostic and therapeutic purposes, 
     and for genetic education and counseling.
       ``(8) Predictive genetic information.--
       ``(A) In general.--The term `predictive genetic 
     information' means, in the absence of symptoms, clinical 
     signs, or a diagnosis of the condition related to such 
     information--
       ``(i) information about an individual's genetic tests;
       ``(ii) information about genetic tests of family members of 
     the individual; or
       ``(iii) information about the occurrence of a disease or 
     disorder in family members.
       ``(B) Exceptions.--The term `predictive genetic 
     information' shall not include--
       ``(i) information about the sex or age of the individual;
       ``(ii) information derived from physical tests, such as the 
     chemical, blood, or urine analyses of the individual 
     including cholesterol tests; and
       ``(iii) information about physical exams of the individual.
       ``(9) Genetic test.--The term `genetic test' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites, including analysis of genotypes, 
     mutations, phenotypes, or karyotypes, for the purpose of 
     predicting risk of disease in asymptomatic or undiagnosed 
     individuals. Such term does not include physical tests, such 
     as the chemical, blood, or urine analyses of the individual 
     including cholesterol tests, and physical exams of the 
     individual, in order to detect symptoms, clinical signs, or a 
     diagnosis of disease.''.
       (d) Effective Date.--Except as provided in this section, 
     this section and the amendments made by this section shall 
     apply with respect to group health plans for plan years 
     beginning 1 year after the date of the enactment of this Act.

     SEC. __03. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

       (a) Amendments Relating to the Group Market.--
       (1) Prohibition of health discrimination on the basis of 
     genetic information in the group market.--
       (A) No enrollment restriction for genetic services.--
     Section 2702(a)(1)(F) of the Public Health Service Act (42 
     U.S.C. 300gg-1(a)(1)(F)) is amended by inserting before the 
     period the following: ``(including information about a 
     request for or receipt of genetic services)''.
       (B) No discrimination in premiums based on predictive 
     genetic information.--Subpart 2 of part A of title XXVII of 
     the Public Health Service Act (42 U.S.C. 300gg-4 et seq.) is 
     amended by adding at the end the following new section:

     ``SEC. 2707. PROHIBITING PREMIUM DISCRIMINATION AGAINST 
                   GROUPS ON THE BASIS OF PREDICTIVE GENETIC 
                   INFORMATION IN THE GROUP MARKET.

       ``A group health plan, or a health insurance issuer 
     offering group health insurance coverage in connection with a 
     group health plan shall not adjust premium or contribution 
     amounts for a group on the basis of predictive genetic 
     information concerning any individual (including a dependent) 
     or family member of the individual (including information 
     about a request for or receipt of genetic services).''.
       (C) Conforming amendment.--Section 2702(b) of the Public 
     Health Service Act (42 U.S.C. 300gg-1(b)) is amended by 
     adding at the end the following:
       ``(3) Reference to related provision.--For a provision 
     prohibiting the adjustment of premium or contribution amounts 
     for a group under a group health plan on the basis of 
     predictive genetic information (including information about a 
     request for or receipt of genetic services), see section 
     2707.''.
       (D) Limitation on collection and disclosure of predictive 
     genetic information.--Section 2702 of the Public Health 
     Service Act (42 U.S.C. 300gg-1) is amended by adding at the 
     end the following:
       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     group health plan, or a health insurance issuer offering 
     health insurance coverage in connection with a group health 
     plan, shall not request or require predictive genetic 
     information concerning any individual (including a dependent) 
     or a family member of the individual (including information 
     about a request for or receipt of genetic services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) In general.--Notwithstanding paragraph (1), a group 
     health plan, or a health insurance issuer offering health 
     insurance coverage in connection with a group health plan, 
     that provides health care items and services to an individual 
     or dependent may request (but may not require) that such 
     individual or dependent disclose, or authorize the collection 
     or disclosure of, predictive genetic information for purposes 
     of diagnosis, treatment, or payment relating to the provision 
     of health care items and services to such individual or 
     dependent.
       ``(B) Notice of confidentiality practices and description 
     of safeguards.--As a part of a request under subparagraph 
     (A), the group health plan, or a health insurance issuer 
     offering health insurance coverage in connection with a group 
     health plan, shall provide to the individual or dependent a 
     description of the procedures in place to safeguard the 
     confidentiality, as described in subsection (d), of such 
     predictive genetic information.
       ``(d) Confidentiality with Respect to Predictive Genetic 
     Information.--
       ``(1) Notice of confidentiality practices.--
       ``(A) Preparation of written notice.--A group health plan, 
     or a health insurance issuer offering health insurance 
     coverage in connection with a group health plan, shall post 
     or provide, in writing and in a clear and conspicuous manner, 
     notice of the plan or issuer's confidentiality practices, 
     that shall include--
       ``(i) a description of an individual's rights with respect 
     to predictive genetic information;

[[Page 13027]]

       ``(ii) the procedures established by the plan or issuer for 
     the exercise of the individual's rights; and
       ``(iii) the right to obtain a copy of the notice of the 
     confidentiality practices required under this subsection.
       ``(B) Model notice.--The Secretary, in consultation with 
     the National Committee on Vital and Health Statistics and the 
     National Association of Insurance Commissioners, and after 
     notice and opportunity for public comment, shall develop and 
     disseminate model notices of confidentiality practices. Use 
     of the model notice shall serve as a defense against claims 
     of receiving inappropriate notice.
       ``(2) Establishment of safeguards.--A group health plan, or 
     a health insurance issuer offering health insurance coverage 
     in connection with a group health plan, shall establish and 
     maintain appropriate administrative, technical, and physical 
     safeguards to protect the confidentiality, security, 
     accuracy, and integrity of predictive genetic information 
     created, received, obtained, maintained, used, transmitted, 
     or disposed of by such plan or issuer.''.
       (2) Definitions.--Section 2791(d) of the Public Health 
     Service Act (42 U.S.C. 300gg-91(d)) is amended by adding at 
     the end the following:
       ``(15) Family member.--The term `family member' means, with 
     respect to an individual--
       ``(A) the spouse of the individual;
       ``(B) a dependent child of the individual, including a 
     child who is born to or placed for adoption with the 
     individual; and
       ``(C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       ``(16) Genetic information.--The term `genetic information' 
     means information about genes, gene products, or inherited 
     characteristics that may derive from an individual or a 
     family member (including information about a request for or 
     receipt of genetic services).
       ``(17) Genetic services.--The term `genetic services' means 
     health services provided to obtain, assess, or interpret 
     genetic information for diagnostic and therapeutic purposes, 
     and for genetic education and counseling.
       ``(18) Predictive genetic information.--
       ``(A) In general.--The term `predictive genetic 
     information' means, in the absence of symptoms, clinical 
     signs, or a diagnosis of the condition related to such 
     information--
       ``(i) information about an individual's genetic tests;
       ``(ii) information about genetic tests of family members of 
     the individual; or
       ``(iii) information about the occurrence of a disease or 
     disorder in family members.
       ``(B) Exceptions.--The term `predictive genetic 
     information' shall not include--
       ``(i) information about the sex or age of the individual;
       ``(ii) information derived from physical tests, such as the 
     chemical, blood, or urine analyses of the individual 
     including cholesterol tests; and
       ``(iii) information about physical exams of the individual.
       ``(19) Genetic test.--The term `genetic test' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites, including analysis of genotypes, 
     mutations, phenotypes, or karyotypes, for the purpose of 
     predicting risk of disease in asymptomatic or undiagnosed 
     individuals. Such term does not include physical tests, such 
     as the chemical, blood, or urine analyses of the individual 
     including cholesterol tests, and physical exams of the 
     individual, in order to detect symptoms, clinical signs, or a 
     diagnosis of disease.''.
       (e) Amendments to PHSA Relating to the Individual Market.--
     The first subpart 3 of part B of title XXVII of the Public 
     Health Service Act (42 U.S.C. 300gg-51 et seq.) (relating to 
     other requirements) (42 U.S.C. 300gg-51 et seq.) is amended 
     by adding at the end the following:

     ``SEC. 2753. PROHIBITION OF HEALTH DISCRIMINATION ON THE 
                   BASIS OF PREDICTIVE GENETIC INFORMATION.

       ``(a) Prohibition on Predictive Genetic Information as a 
     Condition of Eligibility.--A health insurance issuer offering 
     health insurance coverage in the individual market may not 
     use predictive genetic information as a condition of 
     eligibility of an individual to enroll in individual health 
     insurance coverage (including information about a request for 
     or receipt of genetic services).
       ``(b) Prohibition on Predictive Genetic Information in 
     Setting Premium Rates.--A health insurance issuer offering 
     health insurance coverage in the individual market shall not 
     adjust premium rates for individuals on the basis of 
     predictive genetic information concerning such an individual 
     (including a dependent) or a family member of the individual 
     (including information about a request for or receipt of 
     genetic services).
       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     health insurance issuer offering health insurance coverage in 
     the individual market shall not request or require predictive 
     genetic information concerning any individual (including a 
     dependent) or a family member of the individual (including 
     information about a request for or receipt of genetic 
     services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) in general.--Notwithstanding paragraph (1), a health 
     insurance issuer offering health insurance coverage in the 
     individual market that provides health care items and 
     services to an individual or dependent may request (but may 
     not require) that such individual or dependent disclose, or 
     authorize the collection or disclosure of, predictive genetic 
     information for purposes of diagnosis, treatment, or payment 
     relating to the provision of health care items and services 
     to such individual or dependent.
       ``(B) Notice of confidentiality practices and description 
     of safeguards.--As a part of a request under subparagraph 
     (A), the health insurance issuer offering health insurance 
     coverage in the individual market shall provide to the 
     individual or dependent a description of the procedures in 
     place to safeguard the confidentiality, as described in 
     subsection (d), of such predictive genetic information.
       ``(d) Confidentiality with Respect to Predictive Genetic 
     Information.--
       ``(1) Notice of confidentiality practices.--
       ``(A) Preparation of written notice.--A health insurance 
     issuer offering health insurance coverage in the individual 
     market shall post or provide, in writing and in a clear and 
     conspicuous manner, notice of the issuer's confidentiality 
     practices, that shall include--
       ``(i) a description of an individual's rights with respect 
     to predictive genetic information;
       ``(ii) the procedures established by the issuer for the 
     exercise of the individual's rights; and
       ``(iii) the right to obtain a copy of the notice of the 
     confidentiality practices required under this subsection.
       ``(B) Model notice.--The Secretary, in consultation with 
     the National Committee on Vital and Health Statistics and the 
     National Association of Insurance Commissioners, and after 
     notice and opportunity for public comment, shall develop and 
     disseminate model notices of confidentiality practices. Use 
     of the model notice shall serve as a defense against claims 
     of receiving inappropriate notice.
       ``(2) Establishment of safeguards.--A health insurance 
     issuer offering health insurance coverage in the individual 
     market shall establish and maintain appropriate 
     administrative, technical, and physical safeguards to protect 
     the confidentiality, security, accuracy, and integrity of 
     predictive genetic information created, received, obtained, 
     maintained, used, transmitted, or disposed of by such 
     issuer.''.
       (c) Effective Date.--The amendments made by this section 
     shall apply with respect to--
       (1) group health plans, and health insurance coverage 
     offered in connection with group health plans, for plan years 
     beginning after 1 year after the date of enactment of this 
     Act; and
       (2) health insurance coverage offered, sold, issued, 
     renewed, in effect, or operated in the individual market 
     after 1 year after the date of enactment of this Act.

     SEC. __04. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.

       (a) Prohibition of Health Discrimination on the Basis of 
     Genetic Information or Genetic Services.--
       (1) No enrollment restriction for genetic services.--
     Section 9802(a)(1)(F) of the Internal Revenue Code of 1986 is 
     amended by inserting before the period the following: 
     ``(including information about a request for or receipt of 
     genetic services)''.
       (2) No discrimination in group premiums based on predictive 
     genetic information.--
       (A) In general.--Subchapter B of chapter 100 of the 
     Internal Revenue Code of 1986 is further amended by adding at 
     the end the following:

     ``SEC. 9813. PROHIBITING PREMIUM DISCRIMINATION AGAINST 
                   GROUPS ON THE BASIS OF PREDICTIVE GENETIC 
                   INFORMATION.

       ``A group health plan shall not adjust premium or 
     contribution amounts for a group on the basis of predictive 
     genetic information concerning any individual (including a 
     dependent) or a family member of the individual (including 
     information about a request for or receipt of genetic 
     services).''.
       (B) Conforming amendment.--Section 9802(b) of the Internal 
     Revenue Code of 1986 is amended by adding at the end the 
     following:
       ``(3) Reference to related provision.--For a provision 
     prohibiting the adjustment of premium or contribution amounts 
     for a group under a group health plan on the basis of 
     predictive genetic information (including information about a 
     request for or the receipt of genetic services), see section 
     9813.''.
       (C) Amendment to table of sections.--The table of sections 
     for subchapter B of chapter 100 of the Internal Revenue Code 
     of 1986 is amended by adding at the end the following:

``Sec. 9813. Prohibiting premium discrimination against groups on the 
              basis of predictive genetic information.''.

       (b) Limitation on Collection of Predictive Genetic 
     Information.--Section 9802

[[Page 13028]]

     of the Internal Revenue Code of 1986 is amended by adding at 
     the end the following:
       ``(d) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     group health plan shall not request or require predictive 
     genetic information concerning any individual (including a 
     dependent) or a family member of the individual (including 
     information about a request for or receipt of genetic 
     services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) In general.--Notwithstanding paragraph (1), a group 
     health plan that provides health care items and services to 
     an individual or dependent may request (but may not require) 
     that such individual or dependent disclose, or authorize the 
     collection or disclosure of, predictive genetic information 
     for purposes of diagnosis, treatment, or payment relating to 
     the provision of health care items and services to such 
     individual or dependent.
       ``(B) Notice of confidentiality practices; description of 
     safeguards.--As a part of a request under subparagraph (A), 
     the group health plan shall provide to the individual or 
     dependent a description of the procedures in place to 
     safeguard the confidentiality, as described in subsection 
     (e), of such predictive genetic information.
       ``(e) Confidentiality with Respect to Predictive Genetic 
     Information.--
       ``(1) Notice of confidentiality practices.--
       ``(A) Preparation of written notice.--A group health plan 
     shall post or provide, in writing and in a clear and 
     conspicuous manner, notice of the plan's confidentiality 
     practices, that shall include--
       ``(i) a description of an individual's rights with respect 
     to predictive genetic information;
       ``(ii) the procedures established by the plan for the 
     exercise of the individual's rights; and
       ``(iii) the right to obtain a copy of the notice of the 
     confidentiality practices required under this subsection.
       ``(B) Model notice.--The Secretary, in consultation with 
     the National Committee on Vital and Health Statistics and the 
     National Association of Insurance Commissioners, and after 
     notice and opportunity for public comment, shall develop and 
     disseminate model notices of confidentiality practices. Use 
     of the model notice shall serve as a defense against claims 
     of receiving inappropriate notice.
       ``(2) Establishment of safeguards.--A group health plan 
     shall establish and maintain appropriate administrative, 
     technical, and physical safeguards to protect the 
     confidentiality, security, accuracy, and integrity of 
     predictive genetic information created, received, obtained, 
     maintained, used, transmitted, or disposed of by such 
     plan.''.
       (c) Definitions.--Section 9832(d) of the Internal Revenue 
     Code of 1986 is amended by adding at the end the following:
       ``(6) Family member.--The term `family member' means, with 
     respect to an individual--
       ``(A) the spouse of the individual;
       ``(B) a dependent child of the individual, including a 
     child who is born to or placed for adoption with the 
     individual; and
       ``(C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       ``(7) Genetic information.--The term `genetic information' 
     means information about genes, gene products, or inherited 
     characteristics that may derive from an individual or a 
     family member (including information about a request for or 
     receipt of genetic services).
       ``(8) Genetic services.--The term `genetic services' means 
     health services provided to obtain, assess, or interpret 
     genetic information for diagnostic and therapeutic purposes, 
     and for genetic education and counseling.
       ``(9) Predictive genetic information.--
       ``(A) In general.--The term `predictive genetic 
     information' means, in the absence of symptoms, clinical 
     signs, or a diagnosis of the condition related to such 
     information--
       ``(i) information about an individual's genetic tests;
       ``(ii) information about genetic tests of family members of 
     the individual; or
       ``(iii) information about the occurrence of a disease or 
     disorder in family members.
       ``(B) Exceptions.--The term `predictive genetic 
     information' shall not include--
       ``(i) information about the sex or age of the individual;
       ``(ii) information derived from physical tests, such as the 
     chemical, blood, or urine analyses of the individual 
     including cholesterol tests; and
       ``(iii) information about physical exams of the individual.
       ``(10) Genetic test.--The term `genetic test' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites, including analysis of genotypes, 
     mutations, phenotypes, or karyotypes, for the purpose of 
     predicting risk of disease in asymptomatic or undiagnosed 
     individuals. Such term does not include physical tests, such 
     as the chemical, blood, or urine analyses of the individual 
     including cholesterol tests, and physical exams of the 
     individual, in order to detect symptoms, clinical signs, or a 
     diagnosis of disease.''.
       (d) Effective Date.--Except as provided in this section, 
     this section and the amendments made by this section shall 
     apply with respect to group health plans for plan years 
     beginning after 1 year after the date of the enactment of 
     this Act.
                                 ______
                                 

                TORRICELLI (AND REED) AMENDMENT NO. 3692

  (Ordered to lie on the table.)
  Mr. TORRICELLI (for himself and Mr. Reed) submitted an amendment 
intended to be proposed by them to the bill, H.R. 4577, supra; as 
follows:

       On page 26, line 25, strike ``$3,204,496,000, of which'' 
     and insert ``$3,214,496,000, of which $10,000,000 shall be 
     made available to carry out section 317A of the Public Health 
     Service Act and of which''.
       On page 92, between lines 4 and 5, insert the following:
       Sec. __. Amounts made available under this Act for the 
     salaries and expenses of the Department of Labor, the 
     Department of Health and Human Services, and the Department 
     of Education shall be reduced on a pro rata basis, by a total 
     of $10,000,000.
                                 ______
                                 

                 DORGAN (AND OTHERS) AMENDMENT NO. 3693

  Mr. DORGAN (for himself, Mr. Kennedy, Mr. Daschle, Mr. Graham, Ms. 
Mikulski, Mr. Lautenberg, Mr. Kerry, Mr. Edwards, Mr. Harkin, Mr. Reid, 
Mr. Rockefeller, and Mr. Robb) proposed an amendment to the bill, H.R. 
4577, supra; as follows:

       On page 92, between lines 4 and 5, insert the following:
       Sec. __. Any Act that is designed to protect patients 
     against the abuses of managed care that is enacted after June 
     27, 2000, shall, at a minimum--
       (1) provide a floor of Federal protection that is 
     applicable to all individuals enrolled in private health 
     plans or private health insurance coverage, including--
       (A) individuals enrolled in self-insured and insured health 
     plans that are regulated under the Employee Retirement Income 
     Security Act of 1974;
       (B) individuals enrolled in health insurance coverage 
     purchased in the individual market; and
       (C) individuals enrolled in health plans offered to State 
     and local government employees;
       (2) provide that States may provide patient protections 
     that are equal to or greater than the protections provided 
     under such Act; and
       (3) provide the Federal Government with the authority to 
     ensure that the Federal floor referred to in paragraph (1) is 
     being guaranteed and enforced with respect to all individuals 
     described in such paragraph, including determining whether 
     protections provided under State law meet the standards of 
     such Act.
                                 ______
                                 

                       NICKLES AMENDMENT NO. 3694

  Mr. NICKLES proposed an amendment to the bill, H.R. 4577, supra; as 
follows:

       On page 92, strike line 5, and insert the following:

      DIVISION __ HEALTH CARE ACCESS AND PROTECTIONS FOR CONSUMERS

     SEC. 1. SHORT TITLE.

       This division may be cited as the ``Patients' Bill of 
     Rights Plus Act''.

              TITLE I--TAX-RELATED HEALTH CARE PROVISIONS

               Subtitle A--Health Care and Long-Term Care

     SEC. 101. DEDUCTION FOR HEALTH AND LONG-TERM CARE INSURANCE 
                   COSTS OF INDIVIDUALS NOT PARTICIPATING IN 
                   EMPLOYER-SUBSIDIZED HEALTH PLANS.

       (a) In General.--Part VII of subchapter B of chapter 1 of 
     the Internal Revenue Code of 1986 is amended by redesignating 
     section 222 as section 223 and by inserting after section 221 
     the following new section:

     ``SEC. 222. HEALTH AND LONG-TERM CARE INSURANCE COSTS.

       ``(a) In General.--In the case of an individual, there 
     shall be allowed as a deduction an amount equal to the 
     applicable percentage of the amount paid during the taxable 
     year for insurance which constitutes medical care for the 
     taxpayer and the taxpayer's spouse and dependents.
       ``(b) Applicable Percentage.--
       ``(1) In general.--For purposes of subsection (a), the 
     applicable percentage shall be determined in accordance with 
     the following table:

``For taxable years beginning                            The applicable
  in calendar year--                                    percentage is--
  2002 and 2003....................................................25  
  2004.............................................................35  
  2005.............................................................65  
  2006 and thereafter............................................100.  

       ``(2) Long-term care insurance for individuals 60 years or 
     older.--In the case of amounts paid for a qualified long-term 
     care insurance contract for an individual who has attained 
     age 60 before the close of the taxable year, the applicable 
     percentage is 100.

[[Page 13029]]

       ``(c) Limitation Based on Other Coverage.--
       ``(1) Coverage under certain subsidized employer plans.--
       ``(A) In general.--Subsection (a) shall not apply to any 
     taxpayer for any calendar month for which the taxpayer 
     participates in any health plan maintained by any employer of 
     the taxpayer or of the spouse of the taxpayer if 50 percent 
     or more of the cost of coverage under such plan (determined 
     under section 4980B and without regard to payments made with 
     respect to any coverage described in subsection (e)) is paid 
     or incurred by the employer.
       ``(B) Employer contributions to cafeteria plans, flexible 
     spending arrangements, and medical savings accounts.--
     Employer contributions to a cafeteria plan, a flexible 
     spending or similar arrangement, or a medical savings account 
     which are excluded from gross income under section 106 shall 
     be treated for purposes of subparagraph (A) as paid by the 
     employer.
       ``(C) Aggregation of plans of employer.--A health plan 
     which is not otherwise described in subparagraph (A) shall be 
     treated as described in such subparagraph if such plan would 
     be so described if all health plans of persons treated as a 
     single employer under subsection (b), (c), (m), or (o) of 
     section 414 were treated as one health plan.
       ``(D) Separate application to health insurance and long-
     term care insurance.--Subparagraphs (A) and (C) shall be 
     applied separately with respect to--
       ``(i) plans which include primarily coverage for qualified 
     long-term care services or are qualified long-term care 
     insurance contracts, and
       ``(ii) plans which do not include such coverage and are not 
     such contracts.
       ``(2) Coverage under certain federal programs.--
       ``(A) In general.--Subsection (a) shall not apply to any 
     amount paid for any coverage for an individual for any 
     calendar month if, as of the first day of such month, the 
     individual is covered under any medical care program 
     described in--
       ``(i) title XVIII, XIX, or XXI of the Social Security Act,
       ``(ii) chapter 55 of title 10, United States Code,
       ``(iii) chapter 17 of title 38, United States Code,
       ``(iv) chapter 89 of title 5, United States Code, or
       ``(v) the Indian Health Care Improvement Act.
       ``(B) Exceptions.--
       ``(i) Qualified long-term care.--Subparagraph (A) shall not 
     apply to amounts paid for coverage under a qualified long-
     term care insurance contract.
       ``(ii) Continuation coverage of fehbp.--Subparagraph 
     (A)(iv) shall not apply to coverage which is comparable to 
     continuation coverage under section 4980B.
       ``(d) Long-Term Care Deduction Limited to Qualified Long-
     Term Care Insurance Contracts.--In the case of a qualified 
     long-term care insurance contract, only eligible long-term 
     care premiums (as defined in section 213(d)(10)) may be taken 
     into account under subsection (a).
       ``(e) Deduction Not Available for Payment of Ancillary 
     Coverage Premiums.--Any amount paid as a premium for 
     insurance which provides for--
       ``(1) coverage for accidents, disability, dental care, 
     vision care, or a specified illness, or
       ``(2) making payments of a fixed amount per day (or other 
     period) by reason of being hospitalized,
     shall not be taken into account under subsection (a).
       ``(f) Special Rules.--
       ``(1) Coordination with deduction for health insurance 
     costs of self-employed individuals.--The amount taken into 
     account by the taxpayer in computing the deduction under 
     section 162(l) shall not be taken into account under this 
     section.
       ``(2) Coordination with medical expense deduction.--The 
     amount taken into account by the taxpayer in computing the 
     deduction under this section shall not be taken into account 
     under section 213.
       ``(g) Regulations.--The Secretary shall prescribe such 
     regulations as may be appropriate to carry out this section, 
     including regulations requiring employers to report to their 
     employees and the Secretary such information as the Secretary 
     determines to be appropriate.''.
       (b) Deduction Allowed Whether or Not Taxpayer Itemizes 
     Other Deductions.--Subsection (a) of section 62 of such Code 
     is amended by inserting after paragraph (17) the following 
     new item:
       ``(18) Health and long-term care insurance costs.--The 
     deduction allowed by section 222.''.
       (c) Clerical Amendment.--The table of sections for part VII 
     of subchapter B of chapter 1 of such Code is amended by 
     striking the last item and inserting the following new items:

``Sec. 222. Health and long-term care insurance costs.
``Sec. 223. Cross reference.''.

       (d) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     2001.

     SEC. 102. DEDUCTION FOR 100 PERCENT OF HEALTH INSURANCE COSTS 
                   OF SELF-EMPLOYED INDIVIDUALS.

       (a) In General.--Paragraph (1) of section 162(l) of the 
     Internal Revenue Code of 1986 is amended to read as follows:
       ``(1) Allowance of deduction.--In the case of an individual 
     who is an employee within the meaning of section 401(c)(1), 
     there shall be allowed as a deduction under this section an 
     amount equal to 100 percent of the amount paid during the 
     taxable year for insurance which constitutes medical care for 
     the taxpayer and the taxpayer's spouse and dependents.''.
       (b) Clarification of Limitations on Other Coverage.--The 
     first sentence of section 162(l)(2)(B) of such Code is 
     amended to read as follows: ``Paragraph (1) shall not apply 
     to any taxpayer for any calendar month for which the taxpayer 
     participates in any subsidized health plan maintained by any 
     employer (other than an employer described in section 
     401(c)(4)) of the taxpayer or the spouse of the taxpayer.''.
       (c) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     2001.

     SEC. 103. LONG-TERM CARE INSURANCE PERMITTED TO BE OFFERED 
                   UNDER CAFETERIA PLANS AND FLEXIBLE SPENDING 
                   ARRANGEMENTS.

       (a) Cafeteria Plans.--
       (1) In general.--Subsection (f) of section 125 of the 
     Internal Revenue Code of 1986 (defining qualified benefits) 
     is amended by inserting before the period at the end ``; 
     except that such term shall include the payment of premiums 
     for any qualified long-term care insurance contract (as 
     defined in section 7702B) to the extent the amount of such 
     payment does not exceed the eligible long-term care premiums 
     (as defined in section 213(d)(10)) for such contract''.
       (b) Flexible Spending Arrangements.--Section 106 of such 
     Code (relating to contributions by employer to accident and 
     health plans) is amended by striking subsection (c).
       (c) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     2001.

     SEC. 104. ADDITIONAL PERSONAL EXEMPTION FOR TAXPAYER CARING 
                   FOR ELDERLY FAMILY MEMBER IN TAXPAYER'S HOME.

       (a) In General.--Section 151 of the Internal Revenue Code 
     of 1986 (relating to allowance of deductions for personal 
     exemptions) is amended by redesignating subsection (e) as 
     subsection (f) and by inserting after subsection (d) the 
     following new subsection:
       ``(e) Additional Exemption for Certain Elderly Family 
     Members Residing With Taxpayer.--
       ``(1) In general.--An exemption of the exemption amount for 
     each qualified family member of the taxpayer.
       ``(2) Qualified family member.--For purposes of this 
     subsection, the term `qualified family member' means, with 
     respect to any taxable year, any individual--
       ``(A) who is an ancestor of the taxpayer or of the 
     taxpayer's spouse or who is the spouse of any such ancestor,
       ``(B) who is a member for the entire taxable year of a 
     household maintained by the taxpayer, and
       ``(C) who has been certified, before the due date for 
     filing the return of tax for the taxable year (without 
     extensions), by a physician (as defined in section 1861(r)(1) 
     of the Social Security Act) as being an individual with long-
     term care needs described in paragraph (3) for a period--
       ``(i) which is at least 180 consecutive days, and
       ``(ii) a portion of which occurs within the taxable year.
     Such term shall not include any individual otherwise meeting 
     the requirements of the preceding sentence unless within the 
     39\1/2\ month period ending on such due date (or such other 
     period as the Secretary prescribes) a physician (as so 
     defined) has certified that such individual meets such 
     requirements.
       ``(3) Individuals with long-term care needs.--An individual 
     is described in this paragraph if the individual--
       ``(A) is unable to perform (without substantial assistance 
     from another individual) at least two activities of daily 
     living (as defined in section 7702B(c)(2)(B)) due to a loss 
     of functional capacity, or
       ``(B) requires substantial supervision to protect such 
     individual from threats to health and safety due to severe 
     cognitive impairment and is unable to perform, without 
     reminding or cuing assistance, at least one activity of daily 
     living (as so defined) or to the extent provided in 
     regulations prescribed by the Secretary (in consultation with 
     the Secretary of Health and Human Services), is unable to 
     engage in age appropriate activities.
       ``(4) Special rules.--Rules similar to the rules of 
     paragraphs (1), (2), (3), (4), and (5) of section 21(e) shall 
     apply for purposes of this subsection.''.
       (b) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     2001.

[[Page 13030]]



     SEC. 105. STUDY OF LONG-TERM CARE NEEDS IN THE 21ST CENTURY.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary'') shall on 
     or after October 1, 2001, provide, in accordance with this 
     section, for a study in order to determine--
       (1) future demand for long-term health care services 
     (including institutional and home and community-based 
     services) in the United States in order to meet the needs in 
     the 21st century; and
       (2) long-term options to finance the provision of such 
     services.
       (b) Details.--The study conducted under subsection (a) 
     shall include the following:
       (1) An identification of the relevant demographic 
     characteristics affecting demand for long-term health care 
     services, at least through the year 2030.
       (2) The viability and capacity of community-based and other 
     long-term health care services under different federal 
     programs, including through the medicare and medicaid 
     programs, grants to States, housing services, and changes in 
     tax policy.
       (3) How to improve the quality of long-term health care 
     services.
       (4) The integration of long-term health care services for 
     individuals between different classes of health care 
     providers (such as hospitals, nursing facilities, and home 
     care agencies) and different Federal programs (such as the 
     medicare and medicaid programs).
       (5) The possibility of expanding private sector 
     initiatives, including long-term care insurance, to meet the 
     need to finance such services.
       (6) An examination of the effect of enactment of the Health 
     Insurance Portability and Accountability Act of 1996 on the 
     provision and financing of long-term health care services, 
     including on portability and affordability of private long-
     term care insurance, the impact of insurance options on low-
     income older Americans, and the options for eligibility to 
     improve access to such insurance.
       (7) The financial impact of the provision of long-term 
     health care services on caregivers and other family members.
       (c) Report and Recommendations.--
       (1) In general.--October 1, 2002, the Secretary shall 
     provide for a report on the study under this section.
       (2) Recommendations.--The report under paragraph (1) shall 
     include findings and recommendations regarding each of the 
     following:
       (A) The most effective and efficient manner that the 
     Federal Government may use its resources to educate the 
     public on planning for needs for long-term health care 
     services.
       (B) The public, private, and joint public-private 
     strategies for meeting identified needs for long-term health 
     care services.
       (C) The role of States and local communities in the 
     financing of long-term health care services.
       (3) Inclusion of cost estimates.--The report under 
     paragraph (1) shall include cost estimates of the various 
     options for which recommendations are made.
       (d) Conduct of Study.--
       (1) Use of institute of medicine.--The Secretary of Health 
     and Human Services shall seek to enter into an appropriate 
     arrangement with the Institute of Medicine of the National 
     Academy of Sciences to conduct the study under this section. 
     If such an arrangement cannot be made, the Secretary may 
     provide for the conduct of the study by any other qualified 
     non-governmental entity.
       (2) Consultation.--The study should be conducted under this 
     section in consultation with experts from a wide-range of 
     groups from the public and private sectors.

                  Subtitle B--Medical Savings Accounts

     SEC. 111. EXPANSION OF AVAILABILITY OF MEDICAL SAVINGS 
                   ACCOUNTS.

       (a) Repeal of Limitations on Number of Medical Savings 
     Accounts.--
       (1) In general.--Subsections (i) and (j) of section 220 of 
     the Internal Revenue Code of 1986 are hereby repealed.
       (2) Conforming amendments.--
       (A) Paragraph (1) of section 220(c) of such Code is amended 
     by striking subparagraph (D).
       (B) Section 138 of such Code is amended by striking 
     subsection (f).
       (b) Availability Not Limited to Accounts For Employees of 
     Small Employers and Self-employed Individuals.--
       (1) In general.--Section 220(c)(1)(A) of such Code 
     (relating to eligible individual) is amended to read as 
     follows:
       ``(A) In general.--The term `eligible individual' means, 
     with respect to any month, any individual if--
       ``(i) such individual is covered under a high deductible 
     health plan as of the 1st day of such month, and
       ``(ii) such individual is not, while covered under a high 
     deductible health plan, covered under any health plan--

       ``(I) which is not a high deductible health plan, and
       ``(II) which provides coverage for any benefit which is 
     covered under the high deductible health plan.''.

       (2) Conforming amendments.--
       (A) Section 220(c)(1) of such Code is amended by striking 
     subparagraph (C).
       (B) Section 220(c) of such Code is amended by striking 
     paragraph (4) (defining small employer) and by redesignating 
     paragraph (5) as paragraph (4).
       (C) Section 220(b) of such Code is amended by striking 
     paragraph (4) (relating to deduction limited by compensation) 
     and by redesignating paragraphs (5), (6), and (7) as 
     paragraphs (4), (5), and (6), respectively.
       (c) Increase in Amount of Deduction Allowed for 
     Contributions to Medical Savings Accounts.--
       (1) In general.--Paragraph (2) of section 220(b) of such 
     Code is amended to read as follows:
       ``(2) Monthly limitation.--The monthly limitation for any 
     month is the amount equal to \1/12\ of the annual deductible 
     (as of the first day of such month) of the individual's 
     coverage under the high deductible health plan.''.
       (2) Conforming amendment.--Clause (ii) of section 
     220(d)(1)(A) of such Code is amended by striking ``75 percent 
     of''.
       (d) Both Employers and Employees May Contribute to Medical 
     Savings Accounts.--Paragraph (4) of section 220(b) of such 
     Code (as redesignated by subsection (b)(2)(C)) is amended to 
     read as follows:
       ``(4) Coordination with exclusion for employer 
     contributions.--The limitation which would (but for this 
     paragraph) apply under this subsection to the taxpayer for 
     any taxable year shall be reduced (but not below zero) by the 
     amount which would (but for section 106(b)) be includible in 
     the taxpayer's gross income for such taxable year.''.
       (e) Reduction of Permitted Deductibles Under High 
     Deductible Health Plans.--
       (1) In general.--Subparagraph (A) of section 220(c)(2) of 
     such Code (defining high deductible health plan) is amended--
       (A) by striking ``$1,500'' in clause (i) and inserting 
     ``$1,000'';
       (B) by striking ``$3,000'' in clause (ii) and inserting 
     ``$2,000''; and
       (C) by striking the matter preceding subclause (I) in 
     clause (iii) and inserting ``pursuant to which the annual 
     out-of-pocket expenses (including deductibles and co-
     payments) are required to be paid under the plan (other than 
     for premiums) for covered benefits and may not exceed--''.
       (2) Conforming amendment.--Subsection (g) of section 220 of 
     such Code is amended to read as follows:
       ``(g) Cost-of-Living Adjustment.--
       ``(1) In general.--In the case of any taxable year 
     beginning in a calendar year after 2002, each dollar amount 
     in subsection (c)(2) shall be increased by an amount equal 
     to--
       ``(A) such dollar amount, multiplied by
       ``(B) the cost-of-living adjustment determined under 
     section 1(f)(3) for the calendar year in which such taxable 
     year begins by substituting `calendar year 2001' for 
     `calendar year 1992' in subparagraph (B) thereof.
       ``(2) Special rules.--In the case of the $1,000 amount in 
     subsection (c)(2)(A)(i) and the $2,000 amount in subsection 
     (c)(2)(A)(ii), paragraph (1)(B) shall be applied by 
     substituting `calendar year 2002' for `calendar year 2001'.
       ``(3) Rounding.--If any increase under paragraph (1) or (2) 
     is not a multiple of $50, such increase shall be rounded to 
     the nearest multiple of $50.''.
       (f) Limitation on Additional Tax on Distributions Not Used 
     for Qualified Medical Expenses.--Section 220(f)(4) of such 
     Code (relating to additional tax on distributions not used 
     for qualified medical expenses) is amended by adding at the 
     end the following:
       ``(D) Exception in case of sufficient account balance.--
     Subparagraph (A) shall not apply to any payment or 
     distribution in any taxable year, but only to the extent such 
     payment or distribution does not reduce the fair market value 
     of the assets of the medical savings account to an amount 
     less than the annual deductible for the high deductible 
     health plan of the account holder (determined as of the 
     earlier of January 1 of the calendar year in which the 
     taxable year begins or January 1 of the last calendar year in 
     which the account holder is covered under a high deductible 
     health plan).''.
       (g) Treatment of Network-Based Managed Care Plans.--Section 
     220(c)(2)(B) of such Code (relating to special rules for high 
     deductible health plans) is amended by adding at the end the 
     following:
       ``(iii) Treatment of network-based managed care plans.--A 
     plan which provides health care services through a network of 
     contracted or affiliated health care providers, if the 
     benefits provided when services are obtained through network 
     providers meet the requirements of subparagraph (A), shall 
     not fail to be treated as a high deductible health plan by 
     reason of providing benefits for services rendered by 
     providers who are not members of the network, so long as the 
     annual deductible and annual limit on out-of-pocket expenses 
     applicable to services received from non-network providers 
     are not lower than those applicable to services received from 
     the network providers.''.
       (h) Medical Savings Accounts May Be Offered Under Cafeteria 
     Plans.--Subsection (f) of section 125 of such Code is amended 
     by striking ``106(b),''.
       (i) Effective Date.--
       (1) In general.--Except as provided by paragraph (2), the 
     amendments made by this

[[Page 13031]]

     section shall apply to taxable years beginning after December 
     31, 2001.
       (2) Limitation on Additional Tax on Distributions Not Used 
     for Qualified Medical Expenses.--The amendment made by 
     subsection (f) shall apply to taxable years beginning after 
     December 31, 2005.

     SEC. 112. AMENDMENTS TO TITLE 5, UNITED STATES CODE, RELATING 
                   TO MEDICAL SAVINGS ACCOUNTS AND HIGH DEDUCTIBLE 
                   HEALTH PLANS UNDER FEHBP.

       (a) Medical Savings Accounts.--
       (1) Contributions.--Title 5, United States Code, is amended 
     by redesignating section 8906a as section 8906c and by 
     inserting after section 8906 the following:

     ``Sec. 8906a. Government contributions to medical savings 
       accounts

       ``(a) An employee or annuitant enrolled in a high 
     deductible health plan is entitled, in addition to the 
     Government contribution under section 8906(b) toward the 
     subscription charge for such plan, to have a Government 
     contribution made, in accordance with succeeding provisions 
     of this section, to a medical savings account of such 
     employee or annuitant.
       ``(b)(1) The biweekly Government contribution under this 
     section shall, in the case of any such employee or annuitant, 
     be equal to the amount (if any) by which--
       ``(A) the biweekly equivalent of the maximum Government 
     contribution for the contract year involved (as defined by 
     paragraph (2)), exceeds
       ``(B) the amount of the biweekly Government contribution 
     payable on such employee's or annuitant's behalf under 
     section 8906(b) for the period involved.
       ``(2) For purposes of this section, the term `maximum 
     Government contribution' means, with respect to a contract 
     year, the maximum Government contribution that could be made 
     for health benefits for an employee or annuitant for such 
     contract year, as determined under section 8906(b) 
     (disregarding paragraph (2) thereof).
       ``(3) Notwithstanding any other provision of this section, 
     no contribution under this section shall be payable to any 
     medical savings account of an employee or annuitant for any 
     period--
       ``(A) if, as of the first day of the month before the month 
     in which such period commences, such employee or annuitant 
     (or the spouse of such employee or annuitant, if coverage is 
     for self and family) is entitled to benefits under part A of 
     title XVIII of the Social Security Act;
       ``(B) to the extent that such contribution, when added to 
     previous contributions made under this section for that same 
     year with respect to such employee or annuitant, would cause 
     the total to exceed--
       ``(i) the limitation under paragraph (1) of section 220(b) 
     of the Internal Revenue Code of 1986 (determined without 
     regard to paragraph (3) thereof) which is applicable to such 
     employee or annuitant for the calendar year in which such 
     period commences; or
       ``(ii) such lower amount as the employee or annuitant may 
     specify in accordance with regulations of the Office, 
     including an election not to receive contributions under this 
     section for a year or the remainder of a year; or
       ``(C) for which any information (or documentation) under 
     subsection (d) that is needed in order to make such 
     contribution has not been timely submitted.
       ``(4) Notwithstanding any other provision of this section, 
     no contribution under this section shall be payable to any 
     medical savings account of an employee for any period in a 
     contract year unless that employee was enrolled in a health 
     benefits plan under this chapter as an employee for not less 
     than--
       ``(A) the 1 year of service immediately before the start of 
     such contract year, or
       ``(B) the full period or periods of service between the 
     last day of the first period, as prescribed by regulations of 
     the Office of Personnel Management, in which he is eligible 
     to enroll in the plan and the day before the start of such 
     contract year,
     whichever is shorter.
       ``(5) The Office shall provide for the conversion of 
     biweekly rates of contributions specified by paragraph (1) to 
     rates for employees and annuitants whose pay or annuity is 
     provided on other than a biweekly basis, and for this purpose 
     may provide for the adjustment of the converted rate to the 
     nearest cent.
       ``(c) A Government contribution under this section--
       ``(1) shall be made at the same time that, and the same 
     frequency with which, Government contributions under section 
     8906(b) are made for the benefit of the employee or annuitant 
     involved; and
       ``(2) shall be payable from the same appropriation, fund, 
     account, or other source as would any Government 
     contributions under section 8906(b) with respect to the 
     employee or annuitant involved.
       ``(d) The Office shall by regulation prescribe the time, 
     form, and manner in which an employee or annuitant shall 
     submit any information (and supporting documentation) 
     necessary to identify any medical savings account to which 
     contributions under this section are requested to be made.
       ``(e) Nothing in this section shall be considered to 
     entitle an employee or annuitant to any Government 
     contribution under this section with respect to any period 
     for which such employee or annuitant is ineligible for a 
     Government contribution under section 8906(b).

     ``Sec. 8906b. Individual contributions to medical savings 
       accounts

       ``(a) Upon the written request of an employee or annuitant 
     enrolled in a high deductible health plan, there shall be 
     withheld from the pay or annuity of such employee or 
     annuitant and contributed to the medical savings account 
     identified by such employee or annuitant in accordance with 
     applicable regulations under subsection (c) such amount as 
     the employee or annuitant may specify.
       ``(b) Notwithstanding subsection (a), no withholding under 
     this section may be made from the pay or annuity of an 
     employee or annuitant for any period--
       ``(1) if, or to the extent that, a Government contribution 
     for such period under section 8906a would not be allowable by 
     reason of subparagraph (A) or (B)(i) of subsection (b)(3) 
     thereof;
       ``(2) for which any information (or documentation) that is 
     needed in order to make such contribution has not been timely 
     submitted; or
       ``(3) if the employee or annuitant submits a request for 
     termination of withholdings, beginning on or after the 
     effective date of the request and before the end of the year.
       ``(c) The Office of Personnel Management shall prescribe 
     any regulations necessary to carry out this section, 
     including provisions relating to the time, form, and manner 
     in which any request for withholdings under this section may 
     be made, changed, or terminated.''.
       (2) Rules of construction.--Nothing in this section or in 
     any amendment made by this section shall be considered--
       (A) to permit or require that any contributions to a 
     medical savings account (whether by the Government or through 
     withholdings from pay or annuity) be paid into the Employees 
     Health Benefits Fund; or
       (B) to affect any authority under section 1005(f) of title 
     39, United States Code, to vary, add to, or substitute for 
     any provision of chapter 89 of title 5, United States Code, 
     as amended by this section.
       (3) Conforming amendments.--
       (A) The table of sections at the beginning of chapter 89 of 
     title 5, United States Code, is amended by striking the item 
     relating to section 8906a and inserting the following:

``8906a.   Government contributions to medical savings accounts.
``8906b.   Individual contributions to medical savings accounts.
``8906c.   Temporary employees.''.

       (B) Section 8913(b)(4) of title 5, United States Code, is 
     amended by striking ``8906a(a)'' and inserting ``8906c(a)''.
       (b) Informational Requirements.--Section 8907 of title 5, 
     United States Code, is amended by adding at the end the 
     following:
       ``(c) In addition to any information otherwise required 
     under this section, the Office shall make available to all 
     employees and annuitants eligible to enroll in a high 
     deductible health plan, information relating to--
       ``(1) the conditions under which Government contributions 
     under section 8906a shall be made to a medical savings 
     account;
       ``(2) the amount of any Government contributions under 
     section 8906a to which an employee or annuitant may be 
     entitled (or how such amount may be ascertained);
       ``(3) the conditions under which contributions to a medical 
     savings account may be made under section 8906b through 
     withholdings from pay or annuity; and
       ``(4) any other matter the Office considers appropriate in 
     connection with medical savings accounts.''.
       (c) High Deductible Health Plan and Medical Savings Account 
     Defined.--Section 8901 of title 5, United States Code, is 
     amended--
       (1) in paragraph (10) by striking ``and'' after the 
     semicolon;
       (2) in paragraph (11) by striking the period and inserting 
     a semicolon; and
       (3) by adding at the end the following:
       ``(12) the term `high deductible health plan' means a plan 
     described by section 8903(5) or section 8903a(d); and
       ``(13) the term `medical savings account' has the meaning 
     given such term by section 220(d) of the Internal Revenue 
     Code of 1986.''.
       (d) Authority To Contract for High Deductible Health Plans, 
     Etc.--
       (1) Contracts for high deductible health plans.--Section 
     8902 of title 5, United States Code, is amended by adding at 
     the end the following:
       ``(p)(1) The Office shall contract under this chapter for a 
     high deductible health plan with any qualified carrier that 
     offers such a plan and, as of the date of enactment of this 
     subsection, offers a health benefits plan under this chapter.
       ``(2) The Office may contract under this chapter for a high 
     deductible health plan with any qualified carrier that offers 
     such a plan, but does not, as of the date of enactment of 
     this subsection, offer a health benefits plan under this 
     chapter.''.
       (2) Computation of government contributions to plans under 
     chapter 89 not affected by high deductible health plans.--

[[Page 13032]]

     Paragraph (2) of section 8906(a) of title 5, United States 
     Code, is amended by striking ``(2)'' and inserting 
     ``(2)(A)'', and adding at the end the following:
       ``(B) Notwithstanding any other provision of this section, 
     the subscription charges for, and the number of enrollees 
     enrolled in, high deductible health plans shall be 
     disregarded for purposes of determining any weighted average 
     under paragraph (1).''.
       (e) Description of High Deductible Health Plans and 
     Benefits To Be Provided Thereunder.--
       (1) In general.--Section 8903 of title 5, United States 
     Code, is amended by adding at the end the following:
       ``(5) High Deductible Health Plans.--(A) One or more plans 
     described by paragraph (1), (2), (3), or (4), which--
       ``(i) are high deductible health plans (as defined by 
     section 220(c)(2) of the Internal Revenue Code of 1986); and
       ``(ii) provide benefits of the types referred to by section 
     8904(a)(5).
       ``(B) Nothing in this section shall be considered--
       ``(i) to prevent a carrier from simultaneously offering a 
     plan described by subparagraph (A) and a plan described by 
     paragraph (1) or (2); or
       ``(ii) to require that a high deductible health plan offer 
     two levels of benefits.''.
       (2) Types of benefits.--Section 8904(a) of title 5, United 
     States Code, is amended by inserting after paragraph (4) the 
     following:
       ``(5) High Deductible Health Plans.--Benefits of the types 
     named under paragraph (1) or (2) of this subsection or 
     both.''.
       (3) Conforming amendments.--
       (A) Section 8903a of title 5, United States Code, is 
     amended by redesignating subsection (d) as subsection (e) and 
     by inserting after subsection (c) the following:
       ``(d) The plans under this section may include one or more 
     plans, otherwise allowable under this section, that satisfy 
     the requirements of clauses (i) and (ii) of section 
     8903(5)(A).''.
       (B) Section 8909(d) of title 5, United States Code, is 
     amended by striking ``8903a(d)'' and inserting ``8903a(e)''.
       (4) References.--Section 8903 of title 5, United States 
     Code, is amended by adding after paragraph (5) (as added by 
     paragraph (1) of this subsection) as a flush left sentence, 
     the following:
     ``The Office shall prescribe regulations in accordance with 
     which the requirements of section 8902(c), 8902(n), 8909(e), 
     and any other provision of this chapter that applies with 
     respect to a plan described by paragraph (1), (2), (3), or 
     (4) of this section shall apply with respect to the 
     corresponding plan under paragraph (5) of this section. 
     Similar regulations shall be prescribed with respect to any 
     plan under section 8903a(d).''.
       (f) Effective Date.--The amendments made by this section 
     shall apply with respect to contract years beginning on or 
     after October 1, 2001. The Office of Personnel Management 
     shall take appropriate measures to ensure that coverage under 
     a high deductible health plan under chapter 89 of title 5, 
     United States Code (as amended by this section) shall be 
     available as of the beginning of the first contract year 
     described in the preceding sentence.

     SEC. 113. RULE WITH RESPECT TO CERTAIN PLANS.

       (a) In General.--Notwithstanding any other provision of 
     law, health insurance issuers may offer, and eligible 
     individuals may purchase, high deductible health plans 
     described in section 220(c)(2)(A) of the Internal Revenue 
     Code of 1986. Effective for the 5-year period beginning on 
     October 1, 2001, such health plans shall not be required to 
     provide payment for any health care items or services that 
     are exempt from the plan's deductible.
       (b) Existing State Laws.--A State law relating to payment 
     for health care items and services in effect on the date of 
     enactment of this Act that is preempted under paragraph (1), 
     shall not apply to high deductible health plans after the 
     expiration of the 5-year period described in such paragraph 
     unless the State reenacts such law after such period.

              Subtitle C--Other Health-Related Provisions

     SEC. 121. EXPANDED HUMAN CLINICAL TRIALS QUALIFYING FOR 
                   ORPHAN DRUG CREDIT.

       (a) In General.--Subclause (I) of section 45C(b)(2)(A)(ii) 
     of the Internal Revenue Code of 1986 is amended to read as 
     follows:

       ``(I) after the date that the application is filed for 
     designation under such section 526, and''.

       (b) Conforming Amendment.--Clause (i) of section 
     45C(b)(2)(A) of such Code is amended by inserting ``which 
     is'' before ``being'' and by inserting before the comma at 
     the end ``and which is designated under section 526 of such 
     Act''.
       (c) Effective Date.--The amendments made by this section 
     shall apply to amounts paid or incurred after December 31, 
     2001.

     SEC. 122. CARRYOVER OF UNUSED BENEFITS FROM CAFETERIA PLANS, 
                   FLEXIBLE SPENDING ARRANGEMENTS, AND HEALTH 
                   FLEXIBLE SPENDING ACCOUNTS.

       (a) In General.--Section 125 of the Internal Revenue Code 
     of 1986 (relating to cafeteria plans) is amended by 
     redesignating subsections (h) and (i) as subsections (i) and 
     (j) and by inserting after subsection (g) the following new 
     subsection:
       ``(h) Allowance of Carryovers of Unused Benefits to Later 
     Taxable Years.--
       ``(1) In general.--For purposes of this title--
       ``(A) notwithstanding subsection (d)(2), a plan or other 
     arrangement shall not fail to be treated as a cafeteria plan 
     or flexible spending or similar arrangement, and
       ``(B) no amount shall be required to be included in gross 
     income by reason of this section or any other provision of 
     this chapter,
     solely because under such plan or other arrangement any 
     nontaxable benefit which is unused as of the close of a 
     taxable year may be carried forward to 1 or more succeeding 
     taxable years.
       ``(2) Limitation.--Paragraph (1) shall not apply to amounts 
     carried from a plan to the extent such amounts exceed $500 
     (applied on an annual basis). For purposes of this paragraph, 
     all plans and arrangements maintained by an employer or any 
     related person shall be treated as 1 plan.
       ``(3) Allowance of rollover.--
       ``(A) In general.--In the case of any unused benefit 
     described in paragraph (1) which consists of amounts in a 
     health flexible spending account or dependent care flexible 
     spending account, the plan or arrangement shall provide that 
     a participant may elect, in lieu of such carryover, to have 
     such amounts distributed to the participant.
       ``(B) Amounts not included in income.--Any distribution 
     under subparagraph (A) shall not be included in gross income 
     to the extent that such amount is transferred in a trustee-
     to-trustee transfer, or is contributed within 60 days of the 
     date of the distribution, to--
       ``(i) a qualified cash or deferred arrangement described in 
     section 401(k),
       ``(ii) a plan under which amounts are contributed by an 
     individual's employer for an annuity contract described in 
     section 403(b),
       ``(iii) an eligible deferred compensation plan described in 
     section 457, or
       ``(iv) a medical savings account (within the meaning of 
     section 220).
     Any amount rolled over under this subparagraph shall be 
     treated as a rollover contribution for the taxable year from 
     which the unused amount would otherwise be carried.
       ``(C) Treatment of rollover.--Any amount rolled over under 
     subparagraph (B) shall be treated as an eligible rollover 
     under section 220, 401(k), 403(b), or 457, whichever is 
     applicable, and shall be taken into account in applying any 
     limitation (or participation requirement) on employer or 
     employee contributions under such section or any other 
     provision of this chapter for the taxable year of the 
     rollover.
       ``(4) Cost-of-living adjustment.--In the case of any 
     taxable year beginning in a calendar year after 2002, the 
     $500 amount under paragraph (2) shall be adjusted at the same 
     time and in the same manner as under section 415(d)(2), 
     except that the base period taken into account shall be the 
     calendar quarter beginning October 1, 2001, and any increase 
     which is not a multiple of $50 shall be rounded to the next 
     lowest multiple of $50.
       ``(5) Applicability.--This subsection shall apply to 
     taxable years beginning after December 31, 2001.''.
       (b) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     2001.

     SEC. 123. REDUCTION IN TAX ON VACCINES.

       (a) In General.--Paragraph (1) of section 4131(b) of the 
     Internal Revenue Code of 1986 (relating to amount of tax) is 
     amended by striking ``75 cents'' and inserting ``50 cents''.
       (b) Effective Date.--The amendment made by subsection (a) 
     shall take effect on January 1, 2002.

                  Subtitle D--Miscellaneous Provisions

     SEC. 131. NO IMPACT ON SOCIAL SECURITY TRUST FUND.

       (a) In General.--Nothing in this division (or an amendment 
     made by this division) shall be construed to alter or amend 
     the Social Security Act (or any regulation promulgated under 
     that Act).
       (b) Transfers.--
       (1) Estimate of secretary.--The Secretary of the Treasury 
     shall annually estimate the impact that the enactment of this 
     division has on the income and balances of the trust funds 
     established under section 201 of the Social Security Act (42 
     U.S.C. 401).
       (2) Transfer of funds.--If, under paragraph (1), the 
     Secretary of the Treasury estimates that the enactment of 
     this division has a negative impact on the income and 
     balances of the trust funds established under section 201 of 
     the Social Security Act (42 U.S.C. 401), the Secretary shall 
     transfer, not less frequently than quarterly, from the 
     general revenues of the Federal Government an amount 
     sufficient so as to ensure that the income and balances of 
     such trust funds are not reduced as a result of the enactment 
     of such division.

     SEC. 132. CUSTOMS USER FEES.

       Section 13031(j)(3) of the Consolidated Omnibus Budget 
     Reconciliation Act of 1985 (19 U.S.C. 58c(j)(3)) is amended 
     by striking ``2003'' and inserting ``2010''.

     SEC. 133. ESTABLISHMENT OF MEDICARE ADMINISTRATIVE FEE FOR 
                   SUBMISSION OF PAPER CLAIMS.

       (a) Imposition of Fee.--Notwithstanding any other provision 
     of law and subject to

[[Page 13033]]

     subsection (b), the Secretary of Health and Human Services 
     shall establish (in the form of a separate fee or reduction 
     of payment otherwise made under the medicare program under 
     title XVIII of the Social Security Act (42 U.S.C. 1395 et 
     seq.)) an administrative fee of $1 for the submission of a 
     claim in a paper or non-electronic form for items or services 
     for which payment is sought under such title.
       (b) Exception Authority.--The Secretary of Health and Human 
     Services shall waive the imposition of the fee under 
     subsection (a)--
       (1) in cases in which there is no method available for the 
     submission of claims other than in a paper or non-electronic 
     form; and
       (2) for rural providers and small providers that the 
     Secretary determines, under procedures established by the 
     Secretary, are unable to purchase the necessary hardware in 
     order to submit claims electronically.
       (c) Treatment of Fees for Purposes of Cost Reports.--An 
     entity may not include a fee assessed pursuant to this 
     section as an allowable item on a cost report under title 
     XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) or 
     title XIX of such Act (42 U.S.C. 1396 et seq.).
       (d) Effective Date.--The provisions of this section apply 
     to claims submitted on or after January 1, 2002.

     SEC. 134. ESTABLISHMENT OF MEDICARE ADMINISTRATIVE FEE FOR 
                   SUBMISSION OF DUPLICATE AND UNPROCESSABLE 
                   CLAIMS.

       (a) Imposition of Fee.--Notwithstanding any other provision 
     of law, the Secretary of Health and Human Services shall 
     establish (in the form of a separate fee or reduction of 
     payment otherwise made under the medicare program under title 
     XVIII of the Social Security Act (42 U.S.C. 1395 et seq.)) an 
     administrative fee of $2 for the submission of a claim 
     described in subsection (b).
       (b) Claims subject to fee.--A claim described in this 
     subsection is a claim that--
       (1) is submitted by an individual or entity for items or 
     services for which payment is sought under title XVIII of the 
     Social Security Act; and
       (2) either--
       (A) duplicates, in whole or in part, another claim 
     submitted by the same individual or entity; or
       (B) is a claim that cannot be processed and must, in 
     accordance with the Secretary of Health and Human Service's 
     instructions, be returned by the fiscal intermediary or 
     carrier to the individual or entity for completion.
       (c) Treatment of Fees for Purposes of Cost Reports.--An 
     entity may not include a fee assessed pursuant to this 
     section as an allowable item on a cost report under title 
     XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) or 
     title XIX of such Act (42 U.S.C. 1396 et seq.).
       (d) Effective Date.--The provisions of this section apply 
     to claims submitted on or after January 1, 2002.

                   TITLE II--PATIENTS' BILL OF RIGHTS

                  Subtitle A--Right to Advice and Care

     SEC. 201. PATIENT RIGHT TO MEDICAL ADVICE AND CARE.

       (a) In General.--Part 7 of subtitle B of title I of the 
     Employee Retirement Income Security Act of 1974 (29 U.S.C. 
     1181 et seq.) is amended--
       (1) by redesignating subpart C as subpart D; and
       (2) by inserting after subpart B the following:

         ``Subpart C--Patient Right to Medical Advice and Care

     ``SEC. 721. ACCESS TO EMERGENCY MEDICAL CARE.

       ``(a) Coverage of Emergency Services.--If a group health 
     plan (other than a fully insured group health plan) provides 
     coverage for any benefits consisting of emergency medical 
     care, except for items or services specifically excluded from 
     coverage, the plan shall, without regard to prior 
     authorization or provider participation--
       ``(1) provide coverage for emergency medical screening 
     examinations to the extent that a prudent layperson, who 
     possesses an average knowledge of health and medicine, would 
     determine such examinations to be necessary; and
       ``(2) provide coverage for additional emergency medical 
     care to stabilize an emergency medical condition following an 
     emergency medical screening examination (if determined 
     necessary), pursuant to the definition of stabilize under 
     section 1867(e)(3) of the Social Security Act (42 U.S.C. 
     1395dd(e)(3)).
       ``(b) Coverage of Emergency Ambulance Services.--If a group 
     health plan (other than a fully insured group health plan) 
     provides coverage for any benefits consisting of emergency 
     ambulance services, except for items or services specifically 
     excluded from coverage, the plan shall, without regard to 
     prior authorization or provider participation, provide 
     coverage for emergency ambulance services to the extent that 
     a prudent layperson, who possesses an average knowledge of 
     health and medicine, would determine such emergency ambulance 
     services to be necessary.
       ``(c) Care After Stabilization.--
       ``(1) In general.--In the case of medically necessary and 
     appropriate items or services related to the emergency 
     medical condition that may be provided to a participant or 
     beneficiary by a nonparticipating provider after the 
     participant or beneficiary is stabilized, the 
     nonparticipating provider shall contact the plan as soon as 
     practicable, but not later than 2 hours after stabilization 
     occurs, with respect to whether--
       ``(A) the provision of items or services is approved;
       ``(B) the participant or beneficiary will be transferred; 
     or
       ``(C) other arrangements will be made concerning the care 
     and treatment of the participant or beneficiary.
       ``(2) Failure to respond and make arrangements.--If a group 
     health plan fails to respond and make arrangements within 2 
     hours of being contacted in accordance with paragraph (1), 
     then the plan shall be responsible for the cost of any 
     additional items or services provided by the nonparticipating 
     provider if--
       ``(A) coverage for items or services of the type furnished 
     by the nonparticipating provider is available under the plan;
       ``(B) the items or services are medically necessary and 
     appropriate and related to the emergency medical condition 
     involved; and
       ``(C) the timely provision of the items or services is 
     medically necessary and appropriate.
       ``(3) Rule of construction.--Nothing in this subsection 
     shall be construed to apply to a group health plan that does 
     not require prior authorization for items or services 
     provided to a participant or beneficiary after the 
     participant or beneficiary is stabilized.
       ``(d) Reimbursement to a Non-Participating Provider.--The 
     responsibility of a group health plan to provide 
     reimbursement to a nonparticipating provider under this 
     section shall cease accruing upon the earlier of--
       ``(1) the transfer or discharge of the participant or 
     beneficiary; or
       ``(2) the completion of other arrangements made by the plan 
     and the nonparticipating provider.
       ``(e) Responsibility of Participant.--With respect to items 
     or services provided by a nonparticipating provider under 
     this section, the participant or beneficiary shall not be 
     responsible for amounts that exceed the amounts (including 
     co-insurance, co-payments, deductibles or any other form of 
     cost-sharing) that would be incurred if the care was provided 
     by a participating health care provider with prior 
     authorization.
       ``(f) Rule of Construction.--Nothing in this section shall 
     be construed to prohibit a group health plan from negotiating 
     reimbursement rates with a nonparticipating provider for 
     items or services provided under this section.
       ``(g) Definitions.--In this section:
       ``(1) Emergency ambulance services.--The term `emergency 
     ambulance services' means, with respect to a participant or 
     beneficiary under a group health plan (other than a fully 
     insured group health plan), ambulance services furnished to 
     transport an individual who has an emergency medical 
     condition to a treating facility for receipt of emergency 
     medical care if--
       ``(A) the emergency services are covered under the group 
     health plan (other than a fully insured group health plan) 
     involved; and
       ``(B) a prudent layperson who possesses an average 
     knowledge of health and medicine could reasonably expect the 
     absence of such transport to result in placing the health of 
     the participant or beneficiary (or, with respect to a 
     pregnant woman, the health of the woman or her unborn child) 
     in serious jeopardy, serious impairment to bodily functions, 
     or serious dysfunction of any bodily organ or part.
       ``(2) Emergency medical care.--The term `emergency medical 
     care' means, with respect to a participant or beneficiary 
     under a group health plan (other than a fully insured group 
     health plan), covered inpatient and outpatient items or 
     services that--
       ``(A) are furnished by any provider, including a 
     nonparticipating provider, that is qualified to furnish such 
     items or services; and
       ``(B) are needed to evaluate or stabilize (as such term is 
     defined in section 1867(e)(3) of the Social Security Act (42 
     U.S.C. 1395dd(e)(3)) an emergency medical condition.
       ``(3) Emergency medical condition.--The term `emergency 
     medical condition' means a medical condition manifesting 
     itself by acute symptoms of sufficient severity (including 
     severe pain) such that a prudent layperson, who possesses an 
     average knowledge of health and medicine, could reasonably 
     expect the absence of immediate medical attention to result 
     in placing the health of the participant or beneficiary (or, 
     with respect to a pregnant woman, the health of the woman or 
     her unborn child) in serious jeopardy, serious impairment to 
     bodily functions, or serious dysfunction of any bodily organ 
     or part.

     ``SEC. 722. OFFERING OF CHOICE OF COVERAGE OPTIONS.

       ``(a) Requirement.--If a group health plan (other than a 
     fully insured group health plan) provides coverage for 
     benefits only through a defined set of participating health

[[Page 13034]]

     care professionals, the plan shall offer the participant the 
     option to purchase point-of-service coverage (as defined in 
     subsection (b)) for all such benefits for which coverage is 
     otherwise so limited. Such option shall be made available to 
     the participant at the time of enrollment under the plan and 
     at such other times as the plan offers the participant a 
     choice of coverage options.
       ``(b) Point-of-Service Coverage Defined.--In this section, 
     the term `point-of-service coverage' means, with respect to 
     benefits covered under a group health plan (other than a 
     fully insured group health plan), coverage of such benefits 
     when provided by a nonparticipating health care professional.
       ``(c) Small Employer Exemption.--
       ``(1) In general.--This section shall not apply to any 
     group health plan (other than a fully insured group health 
     plan) of a small employer.
       ``(2) Small employer.--For purposes of paragraph (1), the 
     term `small employer' means, in connection with a group 
     health plan (other than a fully insured group health plan) 
     with respect to a calendar year and a plan year, an employer 
     who employed an average of at least 2 but not more than 50 
     employees on business days during the preceding calendar year 
     and who employs at least 2 employees on the first day of the 
     plan year. For purposes of this paragraph, the provisions of 
     subparagraph (C) of section 712(c)(1) shall apply in 
     determining employer size.
       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed--
       ``(1) as requiring coverage for benefits for a particular 
     type of health care professional;
       ``(2) as requiring an employer to pay any costs as a result 
     of this section or to make equal contributions with respect 
     to different health coverage options;
       ``(3) as preventing a group health plan (other than a fully 
     insured group health plan) from imposing higher premiums or 
     cost-sharing on a participant for the exercise of a point-of-
     service coverage option; or
       ``(4) to require that a group health plan (other than a 
     fully insured group health plan) include coverage of health 
     care professionals that the plan excludes because of fraud, 
     quality of care, or other similar reasons with respect to 
     such professionals.

     ``SEC. 723. PATIENT ACCESS TO OBSTETRIC AND GYNECOLOGICAL 
                   CARE.

       ``(a) General Rights.--
       ``(1) Direct access.--A group health plan described in 
     subsection (b) may not require authorization or referral by 
     the primary care provider described in subsection (b)(2) in 
     the case of a female participant or beneficiary who seeks 
     coverage for obstetrical or gynecological care provided by a 
     participating physician who specializes in obstetrics or 
     gynecology.
       ``(2) Obstetrical and gynecological care.--A group health 
     plan described in subsection (b) shall treat the provision of 
     obstetrical and gynecological care, and the ordering of 
     related obstetrical and gynecological items and services, 
     pursuant to the direct access described under paragraph (1), 
     by a participating health care professional who specializes 
     in obstetrics or gynecology as the authorization of the 
     primary care provider.
       ``(b) Application of Section.--A group health plan 
     described in this subsection is a group health plan (other 
     than a fully insured group health plan), that--
       ``(1) provides coverage for obstetric or gynecologic care; 
     and
       ``(2) requires the designation by a participant or 
     beneficiary of a participating primary care provider other 
     than a physician who specializes in obstetrics or gynecology.
       ``(c) Rules of Construction.--Nothing in this section shall 
     be construed--
       ``(1) to require that a group health plan approve or 
     provide coverage for--
       ``(A) any items or services that are not covered under the 
     terms and conditions of the group health plan;
       ``(B) any items or services that are not medically 
     necessary and appropriate; or
       ``(C) any items or services that are provided, ordered, or 
     otherwise authorized under subsection (a)(2) by a physician 
     unless such items or services are related to obstetric or 
     gynecologic care;
       ``(2) to preclude a group health plan from requiring that 
     the physician described in subsection (a) notify the 
     designated primary care professional or case manager of 
     treatment decisions in accordance with a process implemented 
     by the plan, except that the group health plan shall not 
     impose such a notification requirement on the participant or 
     beneficiary involved in the treatment decision;
       ``(3) to preclude a group health plan from requiring 
     authorization, including prior authorization, for certain 
     items and services from the physician described in subsection 
     (a) who specializes in obstetrics and gynecology if the 
     designated primary care provider of the participant or 
     beneficiary would otherwise be required to obtain 
     authorization for such items or services;
       ``(4) to require that the participant or beneficiary 
     described in subsection (a)(1) obtain authorization or a 
     referral from a primary care provider in order to obtain 
     obstetrical or gynecological care from a health care 
     professional other than a physician if the provision of 
     obstetrical or gynecological care by such professional is 
     permitted by the group health plan and consistent with State 
     licensure, credentialing, and scope of practice laws and 
     regulations; or
       ``(5) to preclude the participant or beneficiary described 
     in subsection (a)(1) from designating a health care 
     professional other than a physician as a primary care 
     provider if such designation is permitted by the group health 
     plan and the treatment by such professional is consistent 
     with State licensure, credentialing, and scope of practice 
     laws and regulations.

     ``SEC. 724. ACCESS TO PEDIATRIC CARE.

       ``(a) Pediatric Care.--If a group health plan (other than a 
     fully insured group health plan) requires or provides for a 
     participant or beneficiary to designate a participating 
     primary care provider for a child of such participant or 
     beneficiary, the plan shall permit the participant or 
     beneficiary to designate a physician who specializes in 
     pediatrics as the child's primary care provider if such 
     provider participates in the network of the plan.
       ``(b) Rules of Construction.--With respect to the child of 
     a participant or beneficiary, nothing in subsection (a) shall 
     be construed to--
       ``(1) require that the participant or beneficiary obtain 
     prior authorization or a referral from a primary care 
     provider in order to obtain pediatric care from a health care 
     professional other than a physician if the provision of 
     pediatric care by such professional is permitted by the plan 
     and consistent with State licensure, credentialing, and scope 
     of practice laws and regulations; or
       ``(2) preclude the participant or beneficiary from 
     designating a health care professional other than a physician 
     as a primary care provider for the child if such designation 
     is permitted by the plan and the treatment by such 
     professional is consistent with State licensure, 
     credentialing, and scope of practice laws.

     ``SEC. 725. TIMELY ACCESS TO SPECIALISTS.

       ``(a) Timely Access.--
       ``(1) In general.--A group health plan (other than a fully 
     insured group health plan) shall ensure that participants and 
     beneficiaries receive timely coverage for access to 
     specialists who are appropriate to the medical condition of 
     the participant or beneficiary, when such specialty care is a 
     covered benefit under the plan.
       ``(2) Rule of construction.--Nothing in paragraph (1) shall 
     be construed--
       ``(A) to require the coverage under a group health plan 
     (other than a fully insured group health plan) of benefits or 
     services;
       ``(B) to prohibit a plan from including providers in the 
     network only to the extent necessary to meet the needs of the 
     plan's participants and beneficiaries;
       ``(C) to prohibit a plan from establishing measures 
     designed to maintain quality and control costs consistent 
     with the responsibilities of the plan; or
       ``(D) to override any State licensure or scope-of-practice 
     law.
       ``(3) Access to certain providers.--
       ``(A) Participating providers.--Nothing in this section 
     shall be construed to prohibit a group health plan (other 
     than a fully insured group health plan) from requiring that a 
     participant or beneficiary obtain specialty care from a 
     participating specialist.
       ``(B) Nonparticipating providers.--
       ``(i) In general.--With respect to specialty care under 
     this section, if a group health plan (other than a fully 
     insured group health plan) determines that a participating 
     specialist is not available to provide such care to the 
     participant or beneficiary, the plan shall provide for 
     coverage of such care by a nonparticipating specialist.
       ``(ii) Treatment of nonparticipating providers.--If a group 
     health plan (other than a fully insured group health plan) 
     refers a participant or beneficiary to a nonparticipating 
     specialist pursuant to clause (i), such specialty care shall 
     be provided at no additional cost to the participant or 
     beneficiary beyond what the participant or beneficiary would 
     otherwise pay for such specialty care if provided by a 
     participating specialist.
       ``(b) Referrals.--
       ``(1) Authorization.--Nothing in this section shall be 
     construed to prohibit a group health plan (other than a fully 
     insured group health plan) from requiring an authorization in 
     order to obtain coverage for specialty services so long as 
     such authorization is for an appropriate duration or number 
     of referrals.
       ``(2) Referrals for ongoing special conditions.--
       ``(A) In general.--A group health plan (other than a fully 
     insured group health plan) shall permit a participant or 
     beneficiary who has an ongoing special condition (as defined 
     in subparagraph (B)) to receive a referral to a specialist 
     for the treatment of such condition and such specialist may 
     authorize such referrals, procedures, tests, and other 
     medical services with respect to such condition, or 
     coordinate the care for such condition, subject to the terms 
     of a treatment plan referred to in subsection (c) with 
     respect to the condition.
       ``(B) Ongoing special condition defined.--In this 
     subsection, the term `ongoing special condition' means a 
     condition or disease that--

[[Page 13035]]

       ``(i) is life-threatening, degenerative, or disabling; and
       ``(ii) requires specialized medical care over a prolonged 
     period of time.
       ``(c) Treatment Plans.--
       ``(1) In general.--Nothing in this section shall be 
     construed to prohibit a group health plan (other than a fully 
     insured group health plan) from requiring that specialty care 
     be provided pursuant to a treatment plan so long as the 
     treatment plan is--
       ``(A) developed by the specialist, in consultation with the 
     case manager or primary care provider, and the participant or 
     beneficiary;
       ``(B) approved by the plan in a timely manner if the plan 
     requires such approval; and
       ``(C) in accordance with the applicable quality assurance 
     and utilization review standards of the plan.
       ``(2) Notification.--Nothing in paragraph (1) shall be 
     construed as prohibiting a plan from requiring the specialist 
     to provide the plan with regular updates on the specialty 
     care provided, as well as all other necessary medical 
     information.
       ``(d) Specialist Defined.--For purposes of this section, 
     the term `specialist' means, with respect to the medical 
     condition of the participant or beneficiary, a health care 
     professional, facility, or center (such as a center of 
     excellence) that has adequate expertise (including age-
     appropriate expertise) through appropriate training and 
     experience.
       ``(e) Right to External Review.--Pursuant to the 
     requirements of section 503B, a participant or beneficiary 
     shall have the right to an independent external review if the 
     denial of an item or service or condition that is required to 
     be covered under this section is eligible for such review.

     ``SEC. 726. CONTINUITY OF CARE.

       ``(a) Termination of Provider.--If a contract between a 
     group health plan (other than a fully insured group health 
     plan) and a treating health care provider is terminated (as 
     defined in paragraph (e)(4)), or benefits or coverage 
     provided by a health care provider are terminated because of 
     a change in the terms of provider participation in such plan, 
     and an individual who is a participant or beneficiary in the 
     plan is undergoing an active course of treatment for a 
     serious and complex condition, institutional care, pregnancy, 
     or terminal illness from the provider at the time the plan 
     receives or provides notice of such termination, the plan 
     shall--
       ``(1) notify the individual, or arrange to have the 
     individual notified pursuant to subsection (d)(2), on a 
     timely basis of such termination;
       ``(2) provide the individual with an opportunity to notify 
     the plan of the individual's need for transitional care; and
       ``(3) subject to subsection (c), permit the individual to 
     elect to continue to be covered with respect to the active 
     course of treatment with the provider's consent during a 
     transitional period (as provided for under subsection (b)).
       ``(b) Transitional Period.--
       ``(1) Serious and complex conditions.--The transitional 
     period under this section with respect to a serious and 
     complex condition shall extend for up to 90 days from the 
     date of the notice described in subsection (a)(1) of the 
     provider's termination.
       ``(2) Institutional or inpatient care.--
       ``(A) In general.--The transitional period under this 
     section for institutional or non-elective inpatient care from 
     a provider shall extend until the earlier of--
       ``(i) the expiration of the 90-day period beginning on the 
     date on which the notice described in subsection (a)(1) of 
     the provider's termination is provided; or
       ``(ii) the date of discharge of the individual from such 
     care or the termination of the period of 
     institutionalization.
       ``(B) Scheduled care.--The 90 day limitation described in 
     subparagraph (A)(i) shall include post-surgical follow-up 
     care relating to non-elective surgery that has been scheduled 
     before the date of the notice of the termination of the 
     provider under subsection (a)(1).
       ``(3) Pregnancy.--If--
       ``(A) a participant or beneficiary has entered the second 
     trimester of pregnancy at the time of a provider's 
     termination of participation; and
       ``(B) the provider was treating the pregnancy before the 
     date of the termination;
     the transitional period under this subsection with respect to 
     provider's treatment of the pregnancy shall extend through 
     the provision of post-partum care directly related to the 
     delivery.
       ``(4) Terminal illness.--If--
       ``(A) a participant or beneficiary was determined to be 
     terminally ill (as determined under section 1861(dd)(3)(A) of 
     the Social Security Act) at the time of a provider's 
     termination of participation; and
       ``(B) the provider was treating the terminal illness before 
     the date of termination;
     the transitional period under this subsection shall extend 
     for the remainder of the individual's life for care that is 
     directly related to the treatment of the terminal illness.
       ``(c) Permissible Terms and Conditions.--A group health 
     plan (other than a fully insured group health plan) may 
     condition coverage of continued treatment by a provider under 
     this section upon the provider agreeing to the following 
     terms and conditions:
       ``(1) The treating health care provider agrees to accept 
     reimbursement from the plan and individual involved (with 
     respect to cost-sharing) at the rates applicable prior to the 
     start of the transitional period as payment in full (or at 
     the rates applicable under the replacement plan after the 
     date of the termination of the contract with the group health 
     plan) and not to impose cost-sharing with respect to the 
     individual in an amount that would exceed the cost-sharing 
     that could have been imposed if the contract referred to in 
     this section had not been terminated.
       ``(2) The treating health care provider agrees to adhere to 
     the quality assurance standards of the plan responsible for 
     payment under paragraph (1) and to provide to such plan 
     necessary medical information related to the care provided.
       ``(3) The treating health care provider agrees otherwise to 
     adhere to such plan's policies and procedures, including 
     procedures regarding referrals and obtaining prior 
     authorization and providing services pursuant to a treatment 
     plan (if any) approved by the plan.
       ``(d) Rules of Construction.--Nothing in this section shall 
     be construed--
       ``(1) to require the coverage of benefits which would not 
     have been covered if the provider involved remained a 
     participating provider; or
       ``(2) with respect to the termination of a contract under 
     subsection (a) to prevent a group health plan from requiring 
     that the health care provider--
       ``(A) notify participants or beneficiaries of their rights 
     under this section; or
       ``(B) provide the plan with the name of each participant or 
     beneficiary who the provider believes is eligible for 
     transitional care under this section.
       ``(e) Definitions.--In this section:
       ``(1) Contract.--The term `contract between a plan and a 
     treating health care provider' shall include a contract 
     between such a plan and an organized network of providers.
       ``(2) Health care provider.--The term `health care 
     provider' or `provider' means--
       ``(A) any individual who is engaged in the delivery of 
     health care services in a State and who 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; and
       ``(B) any entity that is engaged in the delivery of health 
     care services in a State and that, if it 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, is so 
     licensed.
       ``(3) Serious and complex condition.--The term `serious and 
     complex condition' means, with respect to a participant or 
     beneficiary under the plan, a condition that is medically 
     determinable and--
       ``(A) in the case of an acute illness, is a condition 
     serious enough to require specialized medical treatment to 
     avoid the reasonable possibility of death or permanent harm; 
     or
       ``(B) in the case of a chronic illness or condition, is an 
     illness or condition that--
       ``(i) is complex and difficult to manage;
       ``(ii) is disabling or life- threatening; and
       ``(iii) requires--

       ``(I) frequent monitoring over a prolonged period of time 
     and requires substantial on-going specialized medical care; 
     or
       ``(II) frequent ongoing specialized medical care across a 
     variety of domains of care.

       ``(4) Terminated.--The term `terminated' includes, with 
     respect to a contract (as defined in paragraph (1)), the 
     expiration or nonrenewal of the contract by the group health 
     plan, but does not include a termination of the contract by 
     the plan for failure to meet applicable quality standards or 
     for fraud.
       ``(f) Right to External Review.--Pursuant to the 
     requirements of section 503B, a participant or beneficiary 
     shall have the right to an independent external review if the 
     denial of an item or service or condition that is required to 
     be covered under this section is eligible for such review.

     ``SEC. 727. PROTECTION OF PATIENT-PROVIDER COMMUNICATIONS.

       ``(a) In General.--Subject to subsection (b), a group 
     health plan (other than a fully insured group health plan and 
     in relation to a participant or beneficiary) shall not 
     prohibit or otherwise restrict a health care professional 
     from advising such a participant or beneficiary who is a 
     patient of the professional about the health status of the 
     participant or beneficiary or medical care or treatment for 
     the condition or disease of the participant or beneficiary, 
     regardless of whether coverage for such care or treatment are 
     provided under the contract, if the professional is acting 
     within the lawful scope of practice.
       ``(b) Rule of Construction.--Nothing in this section shall 
     be construed as requiring a group health plan (other than a 
     fully insured group health plan) to provide specific benefits 
     under the terms of such plan.

     ``SEC. 728. PATIENT'S RIGHT TO PRESCRIPTION DRUGS.

       ``(a) In General.--To the extent that a group health plan 
     (other than a fully insured group health plan) provides 
     coverage for benefits with respect to prescription drugs, and 
     limits such coverage to drugs included in a formulary, the 
     plan shall--

[[Page 13036]]

       ``(1) ensure the participation of physicians and 
     pharmacists in developing and reviewing such formulary; and
       ``(2) in accordance with the applicable quality assurance 
     and utilization review standards of the plan, provide for 
     exceptions from the formulary limitation when a non-formulary 
     alternative is medically necessary and appropriate.
       ``(b) Right to External Review.--Pursuant to the 
     requirements of section 503B, a participant or beneficiary 
     shall have the right to an independent external review if the 
     denial of an item or service or condition that is required to 
     be covered under this section is eligible for such review.

     ``SEC. 729. SELF-PAYMENT FOR BEHAVIORAL HEALTH CARE SERVICES.

       ``(a) In General.--A group health plan (other than a fully 
     insured group health plan) may not--
       ``(1) prohibit or otherwise discourage a participant or 
     beneficiary from self-paying for behavioral health care 
     services once the plan has denied coverage for such services; 
     or
       ``(2) terminate a health care provider because such 
     provider permits participants or beneficiaries to self-pay 
     for behavioral health care services--
       ``(A) that are not otherwise covered under the plan; or
       ``(B) for which the group health plan provides limited 
     coverage, to the extent that the group health plan denies 
     coverage of the services.
       ``(b) Rule of Construction.--Nothing in subsection 
     (a)(2)(B) shall be construed as prohibiting a group health 
     plan from terminating a contract with a health care provider 
     for failure to meet applicable quality standards or for 
     fraud.

     ``SEC. 730. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 
                   APPROVED CANCER CLINICAL TRIALS.

       ``(a) Coverage.--
       ``(1) In general.--If a group health plan (other than a 
     fully insured group health plan) provides coverage to a 
     qualified individual (as defined in subsection (b)), the 
     plan--
       ``(A) may not deny the individual participation in the 
     clinical trial referred to in subsection (b)(2);
       ``(B) subject to subsections (b), (c), and (d) may not deny 
     (or limit or impose additional conditions on) the coverage of 
     routine patient costs for items and services furnished in 
     connection with participation in the trial; and
       ``(C) may not discriminate against the individual on the 
     basis of the participant's or beneficiaries participation in 
     such trial.
       ``(2) Exclusion of certain costs.--For purposes of 
     paragraph (1)(B), routine patient costs do not include the 
     cost of the tests or measurements conducted primarily for the 
     purpose of the clinical trial involved.
       ``(3) Use of in-network providers.--If one or more 
     participating providers is participating in a clinical trial, 
     nothing in paragraph (1) shall be construed as preventing a 
     plan from requiring that a qualified individual participate 
     in the trial through such a participating provider if the 
     provider will accept the individual as a participant in the 
     trial.
       ``(b) Qualified Individual Defined.--For purposes of 
     subsection (a), the term `qualified individual' means an 
     individual who is a participant or beneficiary in a group 
     health plan and who meets the following conditions:
       ``(1)(A) The individual has been diagnosed with cancer for 
     which no standard treatment is effective.
       ``(B) The individual is eligible to participate in an 
     approved clinical trial according to the trial protocol with 
     respect to treatment of such illness.
       ``(C) The individual's participation in the trial offers 
     meaningful potential for significant clinical benefit for the 
     individual.
       ``(2) Either--
       ``(A) the referring physician is a participating health 
     care professional and has concluded that the individual's 
     participation in such trial would be appropriate based upon 
     the individual meeting the conditions described in paragraph 
     (1); or
       ``(B) the participant or beneficiary provides medical and 
     scientific information establishing that the individual's 
     participation in such trial would be appropriate based upon 
     the individual meeting the conditions described in paragraph 
     (1).
       ``(c) Payment.--
       ``(1) In general.--Under this section a group health plan 
     (other than a fully insured group health plan) shall provide 
     for payment for routine patient costs described in subsection 
     (a)(2) but is not required to pay for costs of items and 
     services that are reasonably expected to be paid for by the 
     sponsors of an approved clinical trial.
       ``(2) Standards for determining routine patient costs 
     associated with clinical trial participation.--
       ``(A) In general.--The Secretary shall, in accordance with 
     this paragraph, establish standards relating to the coverage 
     of routine patient costs for individuals participating in 
     clinical trials that group health plans must meet under this 
     section.
       ``(B) Factors.--In establishing routine patient cost 
     standards under subparagraph (A), the Secretary shall consult 
     with interested parties and take into account --
       ``(i) quality of patient care;
       ``(ii) routine patient care costs versus costs associated 
     with the conduct of clinical trials, including unanticipated 
     patient care costs as a result of participation in clinical 
     trials; and
       ``(iii) previous and on-going studies relating to patient 
     care costs associated with participation in clinical trials.
       ``(C) Appointment and meetings of negotiated rulemaking 
     committee.--
       ``(i) Publication of notice.--Not later than November 15, 
     2000, the Secretary shall publish notice of the establishment 
     of a negotiated rulemaking committee, as provided for under 
     section 564(a) of title 5, United States Code, to develop the 
     standards described in subparagraph (A), which shall 
     include--

       ``(I) the proposed scope of the committee;
       ``(II) the interests that may be impacted by the standards;
       ``(iii) a list of the proposed membership of the committee;
       ``(iv) the proposed meeting schedule of the committee;
       ``(v) a solicitation for public comment on the committee; 
     and
       ``(vi) the procedures under which an individual may apply 
     for membership on the committee.

       ``(ii) Comment period.--Notwithstanding section 564(c) of 
     title 5, United States Code, the Secretary shall provide for 
     a period, beginning on the date on which the notice is 
     published under clause (i) and ending on November 30, 2000, 
     for the submission of public comments on the committee under 
     this subparagraph.
       ``(iii) Appointment of committee.--Not later than December 
     30, 2000, the Secretary shall appoint the members of the 
     negotiated rulemaking committee under this subparagraph.
       ``(iv) Facilitator.--Not later than January 10, 2001, the 
     negotiated rulemaking committee shall nominate a facilitator 
     under section 566(c) of title 5, United States Code, to carry 
     out the activities described in subsection (d) of such 
     section.
       ``(v) Meetings.--During the period beginning on the date on 
     which the facilitator is nominated under clause (iv) and 
     ending on March 30, 2001, the negotiated rulemaking committee 
     shall meet to develop the standards described in subparagraph 
     (A).
       ``(D) Preliminary committee report.--
       ``(i) In general.--The negotiated rulemaking committee 
     appointed under subparagraph (C) shall report to the 
     Secretary, by not later than March 30, 2001, regarding the 
     committee's progress on achieving a consensus with regard to 
     the rulemaking proceedings and whether such consensus is 
     likely to occur before the target date described in 
     subsection (F).
       ``(ii) Termination of process and publication of rule by 
     secretary.--If the committee reports under clause (i) that 
     the committee has failed to make significant progress towards 
     such consensus or is unlikely to reach such consensus by the 
     target date described in subsection (F), the Secretary shall 
     terminate such process and provide for the publication in the 
     Federal Register, by not later than June 30, 2001, of a rule 
     under this paragraph through such other methods as the 
     Secretary may provide.
       ``(E) Final committee report and publication or rule by 
     secretary.--
       ``(i) In general.--If the rulemaking committee is not 
     terminated under subparagraph (D)(ii), the committee shall 
     submit to the Secretary, by not later than May 30, 2001, a 
     report containing a proposed rule.
       ``(ii) Publication of rule.--If the Secretary receives a 
     report under clause (i), the Secretary shall provide for the 
     publication in the Federal Register, by not later than June 
     30, 2001, of the proposed rule.
       ``(F) Target date for publication of rule.--As part of the 
     notice under subparagraph (C)(i), and for purposes of this 
     paragraph, the `target date for publication' (referred to in 
     section 564(a)(5) of title 5, United States Code) shall be 
     June 30, 2001.
       ``(G) Effective date.--The provisions of this paragraph 
     shall apply to group health plans (other than a fully insured 
     group health plan) for plan years beginning on or after 
     January 1, 2002.
       ``(3) Payment rate.--In the case of covered items and 
     services provided by--
       ``(A) a participating provider, the payment rate shall be 
     at the agreed upon rate, or
       ``(B) a nonparticipating provider, the payment rate shall 
     be at the rate the plan would normally pay for comparable 
     services under subparagraph (A).
       ``(d) Approved Clinical Trial Defined.--
       ``(1) In general.--In this section, the term `approved 
     clinical trial' means a cancer clinical research study or 
     cancer clinical investigation approved or funded (which may 
     include funding through in-kind contributions) by one or more 
     of the following:
       ``(A) The National Institutes of Health.
       ``(B) A cooperative group or center of the National 
     Institutes of Health.
       ``(C) The Food and Drug Administration.
       ``(D) Either of the following if the conditions described 
     in paragraph (2) are met:
       ``(i) The Department of Veterans Affairs.
       ``(ii) The Department of Defense.
       ``(2) Conditions for departments.--The conditions described 
     in this paragraph, for a

[[Page 13037]]

     study or investigation conducted by a Department, are that 
     the study or investigation has been reviewed and approved 
     through a system of peer review that the Secretary 
     determines--
       ``(A) to be comparable to the system of peer review of 
     studies and investigations used by the National Institutes of 
     Health, and
       ``(B) assures unbiased review of the highest scientific 
     standards by qualified individuals who have no interest in 
     the outcome of the review.
       ``(e) Construction.--Nothing in this section shall be 
     construed to limit a plan's coverage with respect to clinical 
     trials.
       ``(f) Plan Satisfaction of Certain Requirements; 
     Responsibilities of Fiduciaries.--
       ``(1) In general.--For purposes of this section, insofar as 
     a group health plan provides benefits in the form of health 
     insurance coverage through a health insurance issuer, the 
     plan shall be treated as meeting the requirements of this 
     section with respect to such benefits and not be considered 
     as failing to meet such requirements because of a failure of 
     the issuer to meet such requirements so long as the plan 
     sponsor or its representatives did not cause such failure by 
     the issuer.
       ``(2) Construction.--Nothing in this section shall be 
     construed to affect or modify the responsibilities of the 
     fiduciaries of a group health plan under part 4 of subtitle 
     B.
       ``(g) Study and Report.--
       ``(1) Study.--The Secretary shall study the impact on group 
     health plans for covering routine patient care costs for 
     individuals who are entitled to benefits under this section 
     and who are enrolled in an approved cancer clinical trial 
     program.
       ``(2) Report to congress.--Not later than January 1, 2005, 
     the Secretary shall submit a report to Congress that contains 
     an assessment of--
       ``(A) any incremental cost to group health plans resulting 
     from the provisions of this section;
       ``(B) a projection of expenditures to such plans resulting 
     from this section; and
       ``(C) any impact on premiums resulting from this section.
       ``(h) Right to External Review.--Pursuant to the 
     requirements of section 503B, a participant or beneficiary 
     shall have the right to an independent external review if the 
     denial of an item or service or condition that is required to 
     be covered under this section is eligible for such review.

     ``SEC. 730A. PROHIBITION OF DISCRIMINATION AGAINST PROVIDERS 
                   BASED ON LICENSURE.

       ``(a) In General.--A group health plan (other than a fully 
     insured group health plan) shall not discriminate with 
     respect to participation or indemnification as to any 
     provider who is acting within the scope of the provider's 
     license or certification under applicable State law, solely 
     on the basis of such license or certification.
       ``(b) Construction.--Subsection (a) shall not be 
     construed--
       ``(1) as requiring the coverage under a group health plan 
     of a particular benefit or service or to prohibit a plan from 
     including providers only to the extent necessary to meet the 
     needs of the plan's participants or beneficiaries or from 
     establishing any measure designed to maintain quality and 
     control costs consistent with the responsibilities of the 
     plan;
       ``(2) to override any State licensure or scope-of-practice 
     law; or
       ``(3) as requiring a plan that offers network coverage to 
     include for participation every willing provider who meets 
     the terms and conditions of the plan.

     ``SEC. 730B. GENERALLY APPLICABLE PROVISION.

       ``In the case of a group health plan that provides benefits 
     under 2 or more coverage options, the requirements of this 
     subpart shall apply separately with respect to each coverage 
     option.''.
       (b) Rule With Respect to Certain Plans.--
       (1) In general.--Notwithstanding any other provision of 
     law, health insurance issuers may offer, and eligible 
     individuals may purchase, high deductible health plans 
     described in section 220(c)(2)(A) of the Internal Revenue 
     Code of 1986. Effective for the 5-year period beginning on 
     the date of the enactment of this Act, such health plans 
     shall not be required to provide payment for any health care 
     items or services that are exempt from the plan's deductible.
       (2) Existing state laws.--A State law relating to payment 
     for health care items and services in effect on the date of 
     enactment of this Act that is preempted under paragraph (1), 
     shall not apply to high deductible health plans after the 
     expiration of the 5-year period described in such paragraph 
     unless the State reenacts such law after such period.
       (c) Definition.--Section 733(a) of the Employee Retirement 
     Income Security Act of 1974 (42 U.S.C. 1191(a)) is amended by 
     adding at the end the following:
       ``(3) Fully insured group health plan.--The term `fully 
     insured group health plan' means a group health plan where 
     benefits under the plan are provided pursuant to the terms of 
     an arrangement between a group health plan and a health 
     insurance issuer and are guaranteed by the health insurance 
     issuer under a contract or policy of insurance.''.
       (d) Conforming Amendment.--The table of contents in section 
     1 of the Employee Retirement Income Security Act of 1974 is 
     amended--
       (1) in the item relating to subpart C of part 7 of subtitle 
     B of title I, by striking ``Subpart C'' and inserting 
     ``Subpart D''; and
       (2) by adding at the end of the items relating to subpart B 
     of part 7 of subtitle B of title I, the following:

         ``SUBPART C--PATIENT RIGHT TO MEDICAL ADVICE AND CARE

``Sec. 721. Access to emergency medical care.
``Sec. 722. Offering of choice of coverage options.
``Sec. 723. Patient access to obstetric and gynecological care.
``Sec. 724. Access to pediatric care.
``Sec. 725. Timely access to specialists.
``Sec. 726. Continuity of care.
``Sec. 727. Protection of patient-provider communications.
``Sec. 728. Patient's right to prescription drugs.
``Sec. 729. Self-payment for behavioral health care services.
``Sec. 730. Coverage for individuals participating in approved cancer 
              clinical trials.
``Sec. 730A. Prohibition of discrimination against providers based on 
              licensure.
``Sec. 730C. Generally applicable provision.''.

     SEC. 202. CONFORMING AMENDMENT TO THE INTERNAL REVENUE CODE 
                   OF 1986.

       Subchapter B of chapter 100 of the Internal Revenue Code of 
     1986 is amended--
       (1) in the table of sections, by inserting after the item 
     relating to section 9812 the following new item:

``Sec. 9813. Standard relating to patient's bill of rights.'';
     and
       (2) by inserting after section 9812 the following:

     ``SEC. 9813. STANDARD RELATING TO PATIENTS' BILL OF RIGHTS.

       ``A group health plan (other than a fully insured group 
     health plan) shall comply with the requirements of subpart C 
     of part 7 of subtitle B of title I of the Employee Retirement 
     Income Security Act of 1974, as added by section 201 of the 
     Patients' Bill of Rights Plus Act, and such requirements 
     shall be deemed to be incorporated into this section.''.

     SEC. 203. EFFECTIVE DATE AND RELATED RULES.

       (a) In General.--The amendments made by this subtitle shall 
     apply with respect to plan years beginning on or after 
     January 1 of the second calendar year following the date of 
     the enactment of this Act. The Secretary shall issue all 
     regulations necessary to carry out the amendments made by 
     this section before the effective date thereof.
       (b) Limitation on Enforcement Actions.--No enforcement 
     action shall be taken, pursuant to the amendments made by 
     this subtitle, against a group health plan with respect to a 
     violation of a requirement imposed by such amendments before 
     the date of issuance of regulations issued in connection with 
     such requirement, if the plan has sought to comply in good 
     faith with such requirement.

       Subtitle B--Right to Information About Plans and Providers

     SEC. 211. INFORMATION ABOUT PLANS.

       (a) Employee Retirement Income Security Act of 1974.--
     Subpart B of part 7 of subtitle B of title I of the Employee 
     Retirement Income Security Act of 1974 (29 U.S.C. 1185 et 
     seq.) is amended by adding at the end the following:

     ``SEC. 714. HEALTH PLAN INFORMATION.

       ``(a) Requirement--
       ``(1) Disclosure.--
       ``(A) In general.--A group health plan, and a health 
     insurance issuer that provides coverage in connection with 
     group health insurance coverage, shall provide for the 
     disclosure of the information described in subsection (b) to 
     participants and beneficiaries--
       ``(i) at the time of the initial enrollment of the 
     participant or beneficiary under the plan or coverage;
       ``(ii) on an annual basis after enrollment--

       ``(I) in conjunction with the election period of the plan 
     or coverage if the plan or coverage has such an election 
     period; or
       ``(II) in the case of a plan or coverage that does not have 
     an election period, in conjunction with the beginning of the 
     plan or coverage year; and

       ``(iii) in the case of any material reduction to the 
     benefits or information described in paragraphs (1), (2) and 
     (3) of subsection (b), in the form of a summary notice 
     provided not later than the date on which the reduction takes 
     effect.
       ``(B) Participants and beneficiaries.--The disclosure 
     required under subparagraph (A) shall be provided--
       ``(i) jointly to each participant and beneficiary who 
     reside at the same address; or
       ``(ii) in the case of a beneficiary who does not reside at 
     the same address as the participant, separately to the 
     participant and such beneficiary.
       ``(2) Rule of construction.--Nothing in this section shall 
     be construed to prevent a group health plan sponsor and 
     health insurance issuer from entering into an agreement under 
     which either the plan sponsor or the

[[Page 13038]]

     issuer agrees to assume responsibility for compliance with 
     the requirements of this section, in whole or in part, and 
     the party delegating such responsibility is released from 
     liability for compliance with the requirements that are 
     assumed by the other party, to the extent the party 
     delegating such responsibility did not cause such 
     noncompliance.
       ``(3) Provision of information.--Information shall be 
     provided to participants and beneficiaries under this section 
     at the last known address maintained by the plan or issuer 
     with respect to such participants or beneficiaries, to the 
     extent that such information is provided to participants or 
     beneficiaries via the United States Postal Service or other 
     private delivery service.
       ``(b) Required Information.--The informational materials to 
     be distributed under this section shall include for each 
     option available under the group health plan or health 
     insurance coverage the following:
       ``(1) Benefits.--A description of the covered benefits, 
     including--
       ``(A) any in- and out-of-network benefits;
       ``(B) specific preventative services covered under the plan 
     or coverage if such services are covered;
       ``(C) any benefit limitations, including any annual or 
     lifetime benefit limits and any monetary limits or limits on 
     the number of visits, days, or services, and any specific 
     coverage exclusions; and
       ``(D) any definition of medical necessity used in making 
     coverage determinations by the plan, issuer, or claims 
     administrator.
       ``(2) Cost sharing.--A description of any cost-sharing 
     requirements, including--
       ``(A) any premiums, deductibles, coinsurance, copayment 
     amounts, and liability for balance billing above any 
     reasonable and customary charges, for which the participant 
     or beneficiary will be responsible under each option 
     available under the plan;
       ``(B) any maximum out-of-pocket expense for which the 
     participant or beneficiary may be liable;
       ``(C) any cost-sharing requirements for out-of-network 
     benefits or services received from nonparticipating 
     providers; and
       ``(D) any additional cost-sharing or charges for benefits 
     and services that are furnished without meeting applicable 
     plan or coverage requirements, such as prior authorization or 
     precertification.
       ``(3) Service area.--A description of the plan or issuer's 
     service area, including the provision of any out-of-area 
     coverage.
       ``(4) Participating providers.--A directory of 
     participating providers (to the extent a plan or issuer 
     provides coverage through a network of providers) that 
     includes, at a minimum, the name, address, and telephone 
     number of each participating provider, and information about 
     how to inquire whether a participating provider is currently 
     accepting new patients.
       ``(5) Choice of primary care provider.--A description of 
     any requirements and procedures to be used by participants 
     and beneficiaries in selecting, accessing, or changing their 
     primary care provider, including providers both within and 
     outside of the network (if the plan or issuer permits out-of-
     network services), and the right to select a pediatrician as 
     a primary care provider under section 724 for a participant 
     or beneficiary who is a child if such section applies.
       ``(6) Preauthorization requirements.--A description of the 
     requirements and procedures to be used to obtain 
     preauthorization for health services, if such 
     preauthorization is required.
       ``(7) Experimental and investigational treatments.--A 
     description of the process for determining whether a 
     particular item, service, or treatment is considered 
     experimental or investigational, and the circumstances under 
     which such treatments are covered by the plan or issuer.
       ``(8) Specialty care.--A description of the requirements 
     and procedures to be used by participants and beneficiaries 
     in accessing specialty care and obtaining referrals to 
     participating and nonparticipating specialists, including the 
     right to timely coverage for access to specialists care under 
     section 725 if such section applies.
       ``(9) Clinical trials.--A description the circumstances and 
     conditions under which participation in clinical trials is 
     covered under the terms and conditions of the plan or 
     coverage, and the right to obtain coverage for approved 
     cancer clinical trials under section 729 if such section 
     applies.
       ``(10) Prescription drugs.--To the extent the plan or 
     issuer provides coverage for prescription drugs, a statement 
     of whether such coverage is limited to drugs included in a 
     formulary, a description of any provisions and cost-sharing 
     required for obtaining on- and off-formulary medications, and 
     a description of the rights of participants and beneficiaries 
     in obtaining access to access to prescription drugs under 
     section 727 if such section applies.
       ``(11) Emergency services.--A summary of the rules and 
     procedures for accessing emergency services, including the 
     right of a participant or beneficiary to obtain emergency 
     services under the prudent layperson standard under section 
     721, if such section applies, and any educational information 
     that the plan or issuer may provide regarding the appropriate 
     use of emergency services.
       ``(12) Claims and appeals.--A description of the plan or 
     issuer's rules and procedures pertaining to claims and 
     appeals, a description of the rights of participants and 
     beneficiaries under sections 503, 503A and 503B in obtaining 
     covered benefits, filing a claim for benefits, and appealing 
     coverage decisions internally and externally (including 
     telephone numbers and mailing addresses of the appropriate 
     authority), and a description of any additional legal rights 
     and remedies available under section 502.
       ``(13) Advance directives and organ donation.--A 
     description of procedures for advance directives and organ 
     donation decisions if the plan or issuer maintains such 
     procedures.
       ``(14) Information on plans and issuers.--The name, mailing 
     address, and telephone number or numbers of the plan 
     administrator and the issuer to be used by participants and 
     beneficiaries seeking information about plan or coverage 
     benefits and services, payment of a claim, or authorization 
     for services and treatment. The name of the designated 
     decision-maker (or decision-makers) appointed under section 
     502(n)(2) for purposes of making final determinations under 
     section 503A and approving coverage pursuant to the written 
     determination of an independent medical reviewer under 
     section 503B. Notice of whether the benefits under the plan 
     are provided under a contract or policy of insurance issued 
     by an issuer, or whether benefits are provided directly by 
     the plan sponsor who bears the insurance risk.
       ``(15) Translation services.--A summary description of any 
     translation or interpretation services (including the 
     availability of printed information in languages other than 
     English, audio tapes, or information in Braille) that are 
     available for non-English speakers and participants and 
     beneficiaries with communication disabilities and a 
     description of how to access these items or services.
       ``(16) Accreditation information.--Any information that is 
     made public by accrediting organizations in the process of 
     accreditation if the plan or issuer is accredited, or any 
     additional quality indicators (such as the results of 
     enrollee satisfaction surveys) that the plan or issuer makes 
     public or makes available to participants and beneficiaries.
       ``(17) Notice of requirements.--A description of any rights 
     of participants and beneficiaries that are established by the 
     Patients' Bill of Rights Plus Act (excluding those described 
     in paragraphs (1) through (16)) if such sections apply. The 
     description required under this paragraph may be combined 
     with the notices required under sections 711(d), 713(b), or 
     606(a)(1), and with any other notice provision that the 
     Secretary determines may be combined.
       ``(18) Availability of additional information.--A statement 
     that the information described in subsection (c), and 
     instructions on obtaining such information (including 
     telephone numbers and, if available, Internet websites), 
     shall be made available upon request.
       ``(c) Additional Information.--The informational materials 
     to be provided upon the request of a participant or 
     beneficiary shall include for each option available under a 
     group health plan or health insurance coverage the following:
       ``(1) Status of providers.--The State licensure status of 
     the plan or issuer's participating health care professionals 
     and participating health care facilities, and, if available, 
     the education, training, specialty qualifications or 
     certifications of such professionals.
       ``(2) Compensation methods.--A summary description of the 
     methods (such as capitation, fee-for-service, salary, bundled 
     payments, per diem, or a combination thereof) used for 
     compensating participating health care professionals 
     (including primary care providers and specialists) and 
     facilities in connection with the provision of health care 
     under the plan or coverage. The requirement of this paragraph 
     shall not be construed as requiring plans or issuers to 
     provide information concerning proprietary payment 
     methodology.
       ``(3) Prescription drugs.--Information about whether a 
     specific prescription medication is included in the formulary 
     of the plan or issuer, if the plan or issuer uses a defined 
     formulary.
       ``(4) External appeals information.--Aggregate information 
     on the number and outcomes of external medical reviews, 
     relative to the sample size (such as the number of covered 
     lives) determined for the plan or issuer's book of business.
       ``(d) Manner of Disclosure.--The information described in 
     this section shall be disclosed in an accessible medium and 
     format that is calculated to be understood by the average 
     participant.
       ``(e) Rules of Construction.--Nothing in this section shall 
     be construed to prohibit a group health plan, or a health 
     insurance issuer in connection with group health insurance 
     coverage, from--
       ``(1) distributing any other additional information 
     determined by the plan or issuer to be important or necessary 
     in assisting participants and beneficiaries in the selection 
     of a health plan; and

[[Page 13039]]

       ``(2) complying with the provisions of this section by 
     providing information in brochures, through the Internet or 
     other electronic media, or through other similar means, so 
     long as participants and beneficiaries are provided with an 
     opportunity to request that informational materials be 
     provided in printed form.
       ``(f) Conforming Regulations.--The Secretary shall issue 
     regulations to coordinate the requirements on group health 
     plans and health insurance issuers under this section with 
     the requirements imposed under part 1, to reduce duplication 
     with respect to any information that is required to be 
     provided under any such requirements.
       ``(g) Secretarial Enforcement Authority.--
       ``(1) In general.--The Secretary may assess a civil 
     monetary penalty against the administrator of a plan or 
     issuer in connection with the failure of the plan or issuer 
     to comply with the requirements of this section.
       ``(2) Amount of penalty.--
       ``(A) In general.--The amount of the penalty to be imposed 
     under paragraph (1) shall not exceed $100 for each day for 
     each participant and beneficiary with respect to which the 
     failure to comply with the requirements of this section 
     occurs.
       ``(B) Increase in amount.--The amount referred to in 
     subparagraph (A) shall be increased or decreased, for each 
     calendar year that ends after December 31, 2000, by the same 
     percentage as the percentage by which the medical care 
     expenditure category of the Consumer Price Index for All 
     Urban Consumers (United States city average), published by 
     the Bureau of Labor Statistics, for September of the 
     preceding calendar year has increased or decreased from the 
     such Index for September of 2000.
       ``(3) Failure defined.--For purposes of this subsection, a 
     plan or issuer shall have failed to comply with the 
     requirements of this section with respect to a participant or 
     beneficiary if the plan or issuer failed or refused to comply 
     with the requirements of this section within 30 days--
       ``(A) of the date described in subsection (a)(1)(A)(i);
       ``(B) of the date described in subsection (a)(1)(A)(ii); or
       ``(C) of the date on which additional information was 
     requested under subsection (c).''.
       (b) Conforming Amendments.--
       (1) Section 732(a) of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1191a(a)) is amended by 
     striking ``section 711'' and inserting ``sections 711 and 
     714''.
       (2) The table of contents in section 1 of the Employee 
     Retirement Income Security Act of 1974 (29 U.S.C. 1001) is 
     amended by inserting after the item relating to section 713, 
     the following:

``Sec 714. Health plan comparative information.''.

       (3) Section 502(b)(3) of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1132(b)(3)) is amended by 
     striking ``733(a)(1))'' and inserting ``733(a)(1)), except 
     with respect to the requirements of section 714''.

     SEC. 212. INFORMATION ABOUT PROVIDERS.

       (a) Study.--The Secretary of Health and Human Services 
     shall enter into a contract with the Institute of Medicine 
     for the conduct of a study, and the submission to the 
     Secretary of a report, that includes--
       (1) an analysis of information concerning health care 
     professionals that is currently available to patients, 
     consumers, States, and professional societies, nationally and 
     on a State-by-State basis, including patient preferences with 
     respect to information about such professionals and their 
     competencies;
       (2) an evaluation of the legal and other barriers to the 
     sharing of information concerning health care professionals; 
     and
       (3) recommendations for the disclosure of information on 
     health care professionals, including the competencies and 
     professional qualifications of such practitioners, to better 
     facilitate patient choice, quality improvement, and market 
     competition.
       (b) Report.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall forward to the appropriate committees of 
     Congress a copy of the report and study conducted under 
     subsection (a).

           Subtitle C--Right to Hold Health Plans Accountable

     SEC. 221. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY 
                   ACT OF 1974.

       (a) In General.--Part 5 of subtitle B of title I of the 
     Employee Retirement Income Security Act of 1974 is amended by 
     inserting after section 503 (29 U.S.C. 1133) the following:

     ``SEC. 503A. CLAIMS AND INTERNAL APPEALS PROCEDURES FOR GROUP 
                   HEALTH PLANS.

       ``(a) Initial Claim for Benefits Under Group Health 
     Plans.--
       ``(1) Procedures.--
       ``(A) In general.--A group health plan, or health insurance 
     issuer offering health insurance coverage in connection with 
     a group health plan, shall ensure that procedures are in 
     place for--
       ``(i) making a determination on an initial claim for 
     benefits by a participant or beneficiary (or authorized 
     representative) regarding payment or coverage for items or 
     services under the terms and conditions of the plan or 
     coverage involved, including any cost-sharing amount that the 
     participant or beneficiary is required to pay with respect to 
     such claim for benefits; and
       ``(ii) notifying a participant or beneficiary (or 
     authorized representative) and the treating health care 
     professional involved regarding a determination on an initial 
     claim for benefits made under the terms and conditions of the 
     plan or coverage, including any cost-sharing amounts that the 
     participant or beneficiary may be required to make with 
     respect to such claim for benefits, and of the right of the 
     participant or beneficiary to an internal appeal under 
     subsection (b).
       ``(B) Access to information.--With respect to an initial 
     claim for benefits, the participant or beneficiary (or 
     authorized representative) and the treating health care 
     professional (if any) shall provide the plan or issuer with 
     access to information necessary to make a determination 
     relating to the claim, not later than 5 business days after 
     the date on which the claim is filed or to meet the 
     applicable timelines under clauses (ii) and (iii) of 
     paragraph (2)(A).
       ``(C) Oral requests.--In the case of a claim for benefits 
     involving an expedited or concurrent determination, a 
     participant or beneficiary (or authorized representative) may 
     make an initial claim for benefits orally, but a group health 
     plan, or health insurance issuer offering health insurance 
     coverage in connection with a group health plan, may require 
     that the participant or beneficiary (or authorized 
     representative) provide written confirmation of such request 
     in a timely manner.
       ``(2) Timeline for making determinations.--
       ``(A) Prior authorization determination.--
       ``(i) In general.--A group health plan, or health insurance 
     issuer offering health insurance coverage in connection with 
     a group health plan, shall maintain procedures to ensure that 
     a prior authorization determination on a claim for benefits 
     is made within 14 business days from the date on which the 
     plan or issuer receives information that is reasonably 
     necessary to enable the plan or issuer to make a 
     determination on the request for prior authorization, but in 
     no case shall such determination be made later than 28 
     business days after the receipt of the claim for benefits.
       ``(ii) Expedited determination.--Notwithstanding clause 
     (i), a group health plan, or health insurance issuer offering 
     health insurance coverage in connection with a group health 
     plan, shall maintain procedures for expediting a prior 
     authorization determination on a claim for benefits described 
     in such clause when a request for such an expedited 
     determination is made by a participant or beneficiary (or 
     authorized representative) at any time during the process for 
     making a determination and the treating health care 
     professional substantiates, with the request, that a 
     determination under the procedures described in clause (i) 
     would seriously jeopardize the life or health of the 
     participant or beneficiary. Such determination shall be made 
     within 72 hours after a request is received by the plan or 
     issuer under this clause.
       ``(iii) Concurrent determinations.--A group health plan, or 
     health insurance issuer offering health insurance coverage in 
     connection with a group health plan, shall maintain 
     procedures to ensure that a concurrent determination on a 
     claim for benefits that results in a discontinuation of 
     inpatient care is made within 24 hours after the receipt of 
     the claim for benefits.
       ``(B) Retrospective determination.--A group health plan, or 
     health insurance issuer offering health insurance coverage in 
     connection with a group health plan, shall maintain 
     procedures to ensure that a retrospective determination on a 
     claim for benefits is made within 30 business days of the 
     date on which the plan or issuer receives information that is 
     reasonably necessary to enable the plan or issuer to make a 
     determination on the claim, but in no case shall such 
     determination be made later than 60 business days after the 
     receipt of the claim for benefits.
       ``(3) Notice of a denial of a claim for benefits.--Written 
     notice of a denial made under an initial claim for benefits 
     shall be issued to the participant or beneficiary (or 
     authorized representative) and the treating health care 
     professional not later than 2 business days after the 
     determination (or within the 72-hour or 24-hour period 
     referred to in clauses (ii) and (iii) of paragraph (2)(A) if 
     applicable).
       ``(4) Requirements of notice of determinations.--The 
     written notice of a denial of a claim for benefits 
     determination under paragraph (3) shall include--
       ``(A) the reasons for the determination (including a 
     summary of the clinical or scientific-evidence based 
     rationale used in making the determination and instruction on 
     obtaining a more complete description written in a manner 
     calculated to be understood by the average participant);
       ``(B) the procedures for obtaining additional information 
     concerning the determination; and
       ``(C) notification of the right to appeal the determination 
     and instructions on how to initiate an appeal in accordance 
     with subsection (b).

[[Page 13040]]

       ``(b) Internal Appeal of a Denial of a Claim for 
     Benefits.--
       ``(1) Right to internal appeal.--
       ``(A) In general.--A participant or beneficiary (or 
     authorized representative) may appeal any denial of a claim 
     for benefits under subsection (a) under the procedures 
     described in this subsection.
       ``(B) Time for appeal.--A group health plan, or health 
     insurance issuer offering health insurance coverage in 
     connection with a group health plan, shall ensure that a 
     participant or beneficiary (or authorized representative) has 
     a period of not less than 60 days beginning on the date of a 
     denial of a claim for benefits under subsection (a) in which 
     to appeal such denial under this subsection.
       ``(C) Failure to act.--The failure of a plan or issuer to 
     issue a determination on a claim for benefits under 
     subsection (a) within the applicable timeline established for 
     such a determination under such subsection shall be treated 
     as a denial of a claim for benefits for purposes of 
     proceeding to internal review under this subsection.
       ``(D) Plan waiver of internal review.--A group health plan, 
     or health insurance issuer offering health insurance coverage 
     in connection with a group health plan, may waive the 
     internal review process under this subsection and permit a 
     participant or beneficiary (or authorized representative) to 
     proceed directly to external review under section 503B.
       ``(2) Timelines for making determinations.--
       ``(A) Oral requests.--In the case of an appeal of a denial 
     of a claim for benefits under this subsection that involves 
     an expedited or concurrent determination, a participant or 
     beneficiary (or authorized representative) may request such 
     appeal orally, but a group health plan, or health insurance 
     issuer offering health insurance coverage in connection with 
     a group health plan, may require that the participant or 
     beneficiary (or authorized representative) provide written 
     confirmation of such request in a timely manner.
       ``(B) Access to information.--With respect to an appeal of 
     a denial of a claim for benefits, the participant or 
     beneficiary (or authorized representative) and the treating 
     health care professional (if any) shall provide the plan or 
     issuer with access to information necessary to make a 
     determination relating to the appeal, not later than 5 
     business days after the date on which the request for the 
     appeal is filed or to meet the applicable timelines under 
     clauses (ii) and (iii) of subparagraph (C).
       ``(C) Prior authorization determinations.--
       ``(i) In general.--A group health plan, or health insurance 
     issuer offering health insurance coverage in connection with 
     a group health plan, shall maintain procedures to ensure that 
     a determination on an appeal of a denial of a claim for 
     benefits under this subsection is made within 14 business 
     days after the date on which the plan or issuer receives 
     information that is reasonably necessary to enable the plan 
     or issuer to make a determination on the appeal, but in no 
     case shall such determination be made later than 28 business 
     days after the receipt of the request for the appeal.
       ``(ii) Expedited determination.--Notwithstanding clause 
     (i), a group health plan, or health insurance issuer offering 
     health insurance coverage in connection with a group health 
     plan, shall maintain procedures for expediting a prior 
     authorization determination on an appeal of a denial of a 
     claim for benefits described in clause (i), when a request 
     for such an expedited determination is made by a participant 
     or beneficiary (or authorized representative) at any time 
     during the process for making a determination and the 
     treating health care professional substantiates, with the 
     request, that a determination under the procedures described 
     in clause (i) would seriously jeopardize the life or health 
     of the participant or beneficiary. Such determination shall 
     be made not later than 72 hours after the request for such 
     appeal is received by the plan or issuer under this clause.
       ``(iii) Concurrent determinations.--A group health plan, or 
     health insurance issuer offering health insurance coverage in 
     connection with a group health plan, shall maintain 
     procedures to ensure that a concurrent determination on an 
     appeal of a denial of a claim for benefits that results in a 
     discontinuation of inpatient care is made within 24 hours 
     after the receipt of the request for appeal.
       ``(B) Retrospective determination.--A group health plan, or 
     health insurance issuer offering health insurance coverage in 
     connection with a group health plan, shall maintain 
     procedures to ensure that a retrospective determination on an 
     appeal of a claim for benefits is made within 30 business 
     days of the date on which the plan or issuer receives 
     necessary information that is reasonably required by the plan 
     or issuer to make a determination on the appeal, but in no 
     case shall such determination be made later than 60 business 
     days after the receipt of the request for the appeal.
       ``(3) Conduct of review.--
       ``(A) In general.--A review of a denial of a claim for 
     benefits under this subsection shall be conducted by an 
     individual with appropriate expertise who was not directly 
     involved in the initial determination.
       ``(B) Review of medical decisions by physicians.--A review 
     of an appeal of a denial of a claim for benefits that is 
     based on a lack of medical necessity and appropriateness, or 
     based on an experimental or investigational treatment, or 
     requires an evaluation of medical facts, shall be made by a 
     physician with appropriate expertise, including age-
     appropriate expertise, who was not involved in the initial 
     determination.
       ``(4) Notice of determination.--
       ``(A) In general.--Written notice of a determination made 
     under an internal appeal of a denial of a claim for benefits 
     shall be issued to the participant or beneficiary (or 
     authorized representative) and the treating health care 
     professional not later than 2 business days after the 
     completion of the review (or within the 72-hour or 24-hour 
     period referred to in paragraph (2) if applicable).
       ``(B) Final determination.--The decision by a plan or 
     issuer under this subsection shall be treated as the final 
     determination of the plan or issuer on a denial of a claim 
     for benefits. The failure of a plan or issuer to issue a 
     determination on an appeal of a denial of a claim for 
     benefits under this subsection within the applicable timeline 
     established for such a determination shall be treated as a 
     final determination on an appeal of a denial of a claim for 
     benefits for purposes of proceeding to external review under 
     section 503B.
       ``(C) Requirements of notice.--With respect to a 
     determination made under this subsection, the notice 
     described in subparagraph (A) shall include--
       ``(i) the reasons for the determination (including a 
     summary of the clinical or scientific-evidence based 
     rationale used in making the determination and instruction on 
     obtaining a more complete description written in a manner 
     calculated to be understood by the average participant);
       ``(ii) the procedures for obtaining additional information 
     concerning the determination; and
       ``(iii) notification of the right to an independent 
     external review under section 503B and instructions on how to 
     initiate such a review.
       ``(c) Definitions.--The definitions contained in section 
     503B(i) shall apply for purposes of this section.

     ``SEC. 503B. INDEPENDENT EXTERNAL APPEALS PROCEDURES FOR 
                   GROUP HEALTH PLANS.

       ``(a) Right to External Appeal.--A group health plan, and a 
     health insurance issuer offering health insurance coverage in 
     connection with a group health plan, shall provide in 
     accordance with this section participants and beneficiaries 
     (or authorized representatives) with access to an independent 
     external review for any denial of a claim for benefits.
       ``(b) Initiation of the Independent External Review 
     Process.--
       ``(1) Time to file.--A request for an independent external 
     review under this section shall be filed with the plan or 
     issuer not later than 60 business days after the date on 
     which the participant or beneficiary receives notice of the 
     denial under section 503A(b)(4) or the date on which the 
     internal review is waived by the plan or issuer under section 
     503A(b)(1)(D).
       ``(2) Filing of request.--
       ``(A) In general.--Subject to the succeeding provisions of 
     this subsection, a group health plan, and a health insurance 
     issuer offering health insurance coverage in connection with 
     a group health plan, may--
       ``(i) except as provided in subparagraph (B)(i), require 
     that a request for review be in writing;
       ``(ii) limit the filing of such a request to the 
     participant or beneficiary involved (or an authorized 
     representative);
       ``(iii) except if waived by the plan or issuer under 
     section 503A(b)(1)(D), condition access to an independent 
     external review under this section upon a final determination 
     of a denial of a claim for benefits under the internal review 
     procedure under section 503A;
       ``(iv) except as provided in subparagraph (B)(ii), require 
     payment of a filing fee to the plan or issuer of a sum that 
     does not exceed $50; and
       ``(v) require that a request for review include the consent 
     of the participant or beneficiary (or authorized 
     representative) for the release of medical information or 
     records of the participant or beneficiary to the qualified 
     external review entity for purposes of conducting external 
     review activities.
       ``(B) Requirements and exception relating to general 
     rule.--
       ``(i) Oral requests permitted in expedited or concurrent 
     cases.--In the case of an expedited or concurrent external 
     review as provided for under subsection (e), the request may 
     be made orally. In such case a written confirmation of such 
     request shall be made in a timely manner. Such written 
     confirmation shall be treated as a consent for purposes of 
     subparagraph (A)(v).
       ``(ii) Exception to filing fee requirement.--

       ``(I) Indigency.--Payment of a filing fee shall not be 
     required under subparagraph (A)(iv) where there is a 
     certification (in a form and manner specified in guidelines 
     established by the Secretary) that the participant or 
     beneficiary is indigent (as defined in

[[Page 13041]]

     such guidelines). In establishing guidelines under this 
     subclause, the Secretary shall ensure that the guidelines 
     relating to indigency are consistent with the poverty 
     guidelines used by the Secretary of Health and Human Services 
     under title XIX of the Social Security Act.
       ``(II) Fee not required.--Payment of a filing fee shall not 
     be required under subparagraph (A)(iv) if the plan or issuer 
     waives the internal appeals process under section 
     503A(b)(1)(D).
       ``(III) Refunding of fee.--The filing fee paid under 
     subparagraph (A)(iv) shall be refunded if the determination 
     under the independent external review is to reverse the 
     denial which is the subject of the review.
       ``(IV) Increase in amount.--The amount referred to in 
     subclause (I) shall be increased or decreased, for each 
     calendar year that ends after December 31, 2001, by the same 
     percentage as the percentage by which the Consumer Price 
     Index for All Urban Consumers (United States city average), 
     published by the Bureau of Labor Statistics, for September of 
     the preceding calendar year has increased or decreased from 
     the such Index for September of 2001.

       ``(c) Referral to Qualified External Review Entity Upon 
     Request.--
       ``(1) In general.--Upon the filing of a request for 
     independent external review with the group health plan, or 
     health insurance issuer offering coverage in connection with 
     a group health plan, the plan or issuer shall refer such 
     request to a qualified external review entity selected in 
     accordance with this section.
       ``(2) Access to plan or issuer and health professional 
     information.--With respect to an independent external review 
     conducted under this section, the participant or beneficiary 
     (or authorized representative), the plan or issuer, and the 
     treating health care professional (if any) shall provide the 
     external review entity with access to information that is 
     necessary to conduct a review under this section, as 
     determined by the entity, not later than 5 business days 
     after the date on which a request is referred to the 
     qualified external review entity under paragraph (1), or 
     earlier as determined appropriate by the entity to meet the 
     applicable timelines under clauses (ii) and (iii) of 
     subsection (e)(1)(A).
       ``(3) Screening of requests by qualified external review 
     entities.--
       ``(A) In general.--With respect to a request referred to a 
     qualified external review entity under paragraph (1) relating 
     to a denial of a claim for benefits, the entity shall refer 
     such request for the conduct of an independent medical review 
     unless the entity determines that--
       ``(i) any of the conditions described in subsection 
     (b)(2)(A) have not been met;
       ``(ii) the thresholds described in subparagraph (B) have 
     not been met;
       ``(iii) the denial of the claim for benefits does not 
     involve a medically reviewable decision under subsection 
     (d)(2);
       ``(iv) the denial of the claim for benefits relates to a 
     decision regarding whether an individual is a participant or 
     beneficiary who is enrolled under the terms of the plan or 
     coverage (including the applicability of any waiting period 
     under the plan or coverage); or
       ``(v) the denial of the claim for benefits is a decision as 
     to the application of cost-sharing requirements or the 
     application of a specific exclusion or express limitation on 
     the amount, duration, or scope of coverage of items or 
     services under the terms and conditions of the plan or 
     coverage unless the decision is a denial described in 
     subsection (d)(2)(C);
     Upon making a determination that any of clauses (i) through 
     (v) applies with respect to the request, the entity shall 
     determine that the denial of a claim for benefits involved is 
     not eligible for independent medical review under subsection 
     (d), and shall provide notice in accordance with subparagraph 
     (D).
       ``(B) Thresholds.--
       ``(i) In general.--The thresholds described in this 
     subparagraph are that--

       ``(I) the total amount payable under the plan or coverage 
     for the item or service that was the subject of such denial 
     exceeds a significant financial threshold (as determined 
     under guidelines established by the Secretary); or
       ``(II) a physician has asserted in writing that there is a 
     significant risk of placing the life, health, or development 
     of the participant or beneficiary in jeopardy if the denial 
     of the claim for benefits is sustained.

       ``(ii) Thresholds not applied.--The thresholds described in 
     this subparagraph shall not apply if the plan or issuer 
     involved waives the internal appeals process with respect to 
     the denial of a claim for benefits involved under section 
     503A(b)(1)(D).
       ``(C) Process for making determinations.--
       ``(i) No deference to prior determinations.--In making 
     determinations under subparagraph (A), there shall be no 
     deference given to determinations made by the plan or issuer 
     under section 503A or the recommendation of a treating health 
     care professional (if any).
       ``(ii) Use of appropriate personnel.--A qualified external 
     review entity shall use appropriately qualified personnel to 
     make determinations under this section.
       ``(D) Notices and general timelines for determination.--
       ``(i) Notice in case of denial of referral.--If the entity 
     under this paragraph does not make a referral to an 
     independent medical reviewer, the entity shall provide notice 
     to the plan or issuer, the participant or beneficiary (or 
     authorized representative) filing the request, and the 
     treating health care professional (if any) that the denial is 
     not subject to independent medical review. Such notice--

       ``(I) shall be written (and, in addition, may be provided 
     orally) in a manner calculated to be understood by an average 
     participant;
       ``(II) shall include the reasons for the determination; and
       ``(III) include any relevant terms and conditions of the 
     plan or coverage.

       ``(ii) General timeline for determinations.--Upon receipt 
     of information under paragraph (2), the qualified external 
     review entity, and if required the independent medical 
     reviewer, shall make a determination within the overall 
     timeline that is applicable to the case under review as 
     described in subsection (e), except that if the entity 
     determines that a referral to an independent medical reviewer 
     is not required, the entity shall provide notice of such 
     determination to the participant or beneficiary (or 
     authorized representative) within 2 business days of such 
     determination.
       ``(d) Independent Medical Review.--
       ``(1) In general.--If a qualified external review entity 
     determines under subsection (c) that a denial of a claim for 
     benefits is eligible for independent medical review, the 
     entity shall refer the denial involved to an independent 
     medical reviewer for the conduct of an independent medical 
     review under this subsection.
       ``(2) Medically reviewable decisions.--A denial described 
     in this paragraph is one for which the item or service that 
     is the subject of the denial would be a covered benefit under 
     the terms and conditions of the plan or coverage but for one 
     (or more) of the following determinations:
       ``(A) Denials based on medical necessity and 
     appropriateness.--The basis of the determination is that the 
     item or service is not medically necessary and appropriate.
       ``(B) Denials based on experimental or investigational 
     treatment.--The basis of the determination is that the item 
     or service is experimental or investigational.
       ``(C) Denials otherwise based on an evaluation of medical 
     facts.--A determination that the item or service or condition 
     is not covered but an evaluation of the medical facts by a 
     health care professional in the specific case involved is 
     necessary to determine whether the item or service or 
     condition is required to be provided under the terms and 
     conditions of the plan or coverage.
       ``(3) Independent medical review determination.--
       ``(A) In general.--An independent medical reviewer under 
     this section shall make a new independent determination with 
     respect to--
       ``(i) whether the item or service or condition that is the 
     subject of the denial is covered under the terms and 
     conditions of the plan or coverage; and
       ``(ii) based upon an affirmative determination under clause 
     (i), whether or not the denial of a claim for a benefit that 
     is the subject of the review should be upheld or reversed.
       ``(B) Standard for determination.--The independent medical 
     reviewer's determination relating to the medical necessity 
     and appropriateness, or the experimental or investigation 
     nature, or the evaluation of the medical facts of the item, 
     service, or condition shall be based on the medical condition 
     of the participant or beneficiary (including the medical 
     records of the participant or beneficiary) and the valid, 
     relevant scientific evidence and clinical evidence, including 
     peer-reviewed medical literature or findings and including 
     expert consensus.
       ``(C) No coverage for excluded benefits.--Nothing in this 
     subsection shall be construed to permit an independent 
     medical reviewer to require that a group health plan, or 
     health insurance issuer offering health insurance coverage in 
     connection with a group health plan, provide coverage for 
     items or services that are specifically excluded or expressly 
     limited under the plan or coverage and that are not covered 
     regardless of any determination relating to medical necessity 
     and appropriateness, experimental or investigational nature 
     of the treatment, or an evaluation of the medical facts in 
     the case involved.
       ``(D) Evidence and information to be used in medical 
     reviews.--In making a determination under this subsection, 
     the independent medical reviewer shall also consider 
     appropriate and available evidence and information, including 
     the following:
       ``(i) The determination made by the plan or issuer with 
     respect to the claim upon internal review and the evidence or 
     guidelines used by the plan or issuer in reaching such 
     determination.
       ``(ii) The recommendation of the treating health care 
     professional and the evidence, guidelines, and rationale used 
     by the treating health care professional in reaching such 
     recommendation.
       ``(iii) Additional evidence or information obtained by the 
     reviewer or submitted by the

[[Page 13042]]

     plan, issuer, participant or beneficiary (or an authorized 
     representative), or treating health care professional.
       ``(iv) The plan or coverage document.
       ``(E) Independent determination.--In making the 
     determination, the independent medical reviewer shall--
       ``(i) consider the claim under review without deference to 
     the determinations made by the plan or issuer under section 
     503A or the recommendation of the treating health care 
     professional (if any);
       ``(ii) consider, but not be bound by the definition used by 
     the plan or issuer of `medically necessary and appropriate', 
     or `experimental or investigational', or other equivalent 
     terms that are used by the plan or issuer to describe medical 
     necessity and appropriateness or experimental or 
     investigational nature of the treatment; and
       ``(iii) notwithstanding clause (ii), adhere to the 
     definition used by the plan or issuer of `medically necessary 
     and appropriate', or `experimental or investigational' if 
     such definition is the same as the definition of such term--

       ``(I) that has been adopted pursuant to a State statute or 
     regulation; or
       ``(II) that is used for purposes of the program established 
     under titles XVIII or XIX of the Social Security Act or under 
     chapter 89 of title 5, United States Code.

       ``(F) Determination of independent medical reviewer.--An 
     independent medical reviewer shall, in accordance with the 
     deadlines described in subsection (e), prepare a written 
     determination to uphold or reverse the denial under review. 
     Such written determination shall include the specific reasons 
     of the reviewer for such determination, including a summary 
     of the clinical or scientific-evidence based rationale used 
     in making the determination. The reviewer may provide the 
     plan or issuer and the treating health care professional with 
     additional recommendations in connection with such a 
     determination, but any such recommendations shall not be 
     treated as part of the determination.
       ``(e) Timelines and Notifications.--
       ``(1) Timelines for independent medical review.--
       ``(A) Prior authorization determination.--
       ``(i) In general.--The independent medical reviewer (or 
     reviewers) shall make a determination on a denial of a claim 
     for benefits that is referred to the reviewer under 
     subsection (c)(3) not later than 14 business days after the 
     receipt of information under subsection (c)(2) if the review 
     involves a prior authorization of items or services.
       ``(ii) Expedited determination.--Notwithstanding clause 
     (i), the independent medical reviewer (or reviewers) shall 
     make an expedited determination on a denial of a claim for 
     benefits described in clause (i), when a request for such an 
     expedited determination is made by a participant or 
     beneficiary (or authorized representative) at any time during 
     the process for making a determination, and the treating 
     health care professional substantiates, with the request, 
     that a determination under the timeline described in clause 
     (i) would seriously jeopardize the life or health of the 
     participant or beneficiary. Such determination shall be made 
     not later than 72 hours after the receipt of information 
     under subsection (c)(2).
       ``(iii) Concurrent determination.--Notwithstanding clause 
     (i), a review described in such subclause shall be completed 
     not later than 24 hours after the receipt of information 
     under subsection (c)(2) if the review involves a 
     discontinuation of inpatient care.
       ``(B) Retrospective determination.--The independent medical 
     reviewer (or reviewers) shall complete a review in the case 
     of a retrospective determination on an appeal of a denial of 
     a claim for benefits that is referred to the reviewer under 
     subsection (c)(3) not later than 30 business days after the 
     receipt of information under subsection (c)(2).
       ``(2) Notification of determination.--The external review 
     entity shall ensure that the plan or issuer, the participant 
     or beneficiary (or authorized representative) and the 
     treating health care professional (if any) receives a copy of 
     the written determination of the independent medical reviewer 
     prepared under subsection (d)(3)(F). Nothing in this 
     paragraph shall be construed as preventing an entity or 
     reviewer from providing an initial oral notice of the 
     reviewer's determination.
       ``(3) Form of notices.--Determinations and notices under 
     this subsection shall be written in a manner calculated to be 
     understood by an average participant.
       ``(4) Termination of external review process if approval of 
     a claim for benefits during process.--
       ``(A) In general.--If a plan or issuer--
       ``(i) reverses a determination on a denial of a claim for 
     benefits that is the subject of an external review under this 
     section and authorizes coverage for the claim or provides 
     payment of the claim; and
       ``(ii) provides notice of such reversal to the participant 
     or beneficiary (or authorized representative) and the 
     treating health care professional (if any), and the external 
     review entity responsible for such review,
     the external review process shall be terminated with respect 
     to such denial and any filing fee paid under subsection 
     (b)(2)(A)(iv) shall be refunded.
       ``(B) Treatment of termination.--An authorization of 
     coverage under subparagraph (A) by the plan or issuer shall 
     be treated as a written determination to reverse a denial 
     under section (d)(3)(F) for purposes of liability under 
     section 502(n)(1)(B).
       ``(f) Compliance.--
       ``(1) Application of determinations.--
       ``(A) External review determinations binding on plan.--The 
     determinations of an external review entity and an 
     independent medical reviewer under this section shall be 
     binding upon the plan or issuer involved.
       ``(B) Compliance with determination.--If the determination 
     of an independent medical reviewer is to reverse the denial, 
     the plan or issuer, upon the receipt of such determination, 
     shall authorize coverage to comply with the medical 
     reviewer's determination in accordance with the timeframe 
     established by the medical reviewer.
       ``(2) Failure to comply.--If a plan or issuer fails to 
     comply with the timeframe established under paragraph 
     (1)(B)(i) with respect to a participant or beneficiary, where 
     such failure to comply is caused by the plan or issuer, the 
     participant or beneficiary may obtain the items or services 
     involved (in a manner consistent with the determination of 
     the independent external reviewer) from any provider 
     regardless of whether such provider is a participating 
     provider under the plan or coverage.
       ``(3) Reimbursement.--
       ``(A) In general.--Where a participant or beneficiary 
     obtains items or services in accordance with paragraph (2), 
     the plan or issuer involved shall provide for reimbursement 
     of the costs of such items of services. Such reimbursement 
     shall be made to the treating health care professional or to 
     the participant or beneficiary (in the case of a participant 
     or beneficiary who pays for the costs of such items or 
     services).
       ``(B) Amount.--The plan or issuer shall fully reimburse a 
     professional, participant or beneficiary under subparagraph 
     (A) for the total costs of the items or services provided 
     (regardless of any plan limitations that may apply to the 
     coverage of such items of services) so long as--
       ``(i) the items or services would have been covered under 
     the terms of the plan or coverage if provided by the plan or 
     issuer; and
       ``(ii) the items or services were provided in a manner 
     consistent with the determination of the independent medical 
     reviewer.
       ``(4) Failure to reimburse.--Where a plan or issuer fails 
     to provide reimbursement to a professional, participant or 
     beneficiary in accordance with this subsection, the 
     professional, participant or beneficiary may commence a civil 
     action (or utilize other remedies available under law) to 
     recover only the amount of any such reimbursement that is 
     unpaid and any necessary legal costs or expenses (including 
     attorneys' fees) incurred in recovering such reimbursement.
       ``(g) Qualifications of Independent Medical Reviewers.--
       ``(1) In general.--In referring a denial to 1 or more 
     individuals to conduct independent medical review under 
     subsection (c), the qualified external review entity shall 
     ensure that--
       ``(A) each independent medical reviewer meets the 
     qualifications described in paragraphs (2) and (3);
       ``(B) with respect to each review at least 1 such reviewer 
     meets the requirements described in paragraphs (4) and (5); 
     and
       ``(C) compensation provided by the entity to the reviewer 
     is consistent with paragraph (6).
       ``(2) Licensure and expertise.--Each independent medical 
     reviewer shall be a physician or health care professional 
     who--
       ``(A) is appropriately credentialed or licensed in 1 or 
     more States to deliver health care services; and
       ``(B) typically treats the diagnosis or condition or 
     provides the type or treatment under review.
       ``(3) Independence.--
       ``(A) In general.--Subject to subparagraph (B), each 
     independent medical reviewer in a case shall--
       ``(i) not be a related party (as defined in paragraph (7));
       ``(ii) not have a material familial, financial, or 
     professional relationship with such a party; and
       ``(iii) not otherwise have a conflict of interest with such 
     a party (as determined under regulations).
       ``(B) Exception.--Nothing in this subparagraph (A) shall be 
     construed to--
       ``(i) prohibit an individual, solely on the basis of 
     affiliation with the plan or issuer, from serving as an 
     independent medical reviewer if--

       ``(I) a non-affiliated individual is not reasonably 
     available;
       ``(II) the affiliated individual is not involved in the 
     provision of items or services in the case under review; and
       ``(III) the fact of such an affiliation is disclosed to the 
     plan or issuer and the participant or beneficiary (or 
     authorized representative) and neither party objects;

       ``(ii) prohibit an individual who has staff privileges at 
     the institution where the treatment involved takes place from 
     serving as an independent medical reviewer if the affiliation 
     is disclosed to the plan or issuer and the participant or 
     beneficiary (or authorized representative), and neither party 
     objects;

[[Page 13043]]

       ``(iii) permit an employee of a plan or issuer, or an 
     individual who provides services exclusively or primarily to 
     or on behalf of a plan or issuer, from serving as an 
     independent medical reviewer; or
       ``(iv) prohibit receipt of compensation by an independent 
     medical reviewer from an entity if the compensation is 
     provided consistent with paragraph (6).
       ``(4) Practicing health care professional in same field.--
       ``(A) In general.--The requirement of this paragraph with 
     respect to a reviewer in a case involving treatment, or the 
     provision of items or services, by--
       ``(i) a physician, is that the reviewer be a practicing 
     physician of the same or similar specialty, when reasonably 
     available, as a physician who typically treats the diagnosis 
     or condition or provides such treatment in the case under 
     review; or
       ``(ii) a health care professional (other than a physician), 
     is that the reviewer be a practicing physician or, if 
     determined appropriate by the qualified external review 
     entity, a health care professional (other than a physician), 
     of the same or similar specialty as the health care 
     professional who typically treats the diagnosis or condition 
     or provides the treatment in the case under review.
       ``(B) Practicing defined.--For purposes of this paragraph, 
     the term `practicing' means, with respect to an individual 
     who is a physician or other health care professional that the 
     individual provides health care services to individual 
     patients on average at least 1 day per week.
       ``(5) Age-appropriate expertise.--The independent medical 
     reviewer shall have expertise under paragraph (2) that is 
     age-appropriate to the participant or beneficiary involved.
       ``(6) Limitations on reviewer compensation.--Compensation 
     provided by a qualified external review entity to an 
     independent medical reviewer in connection with a review 
     under this section shall--
       ``(A) not exceed a reasonable level; and
       ``(B) not be contingent on the decision rendered by the 
     reviewer.
       ``(7) Related party defined.--For purposes of this section, 
     the term `related party' means, with respect to a denial of a 
     claim under a plan or coverage relating to a participant or 
     beneficiary, any of the following:
       ``(A) The plan, plan sponsor, or issuer involved, or any 
     fiduciary, officer, director, or employee of such plan, plan 
     sponsor, or issuer.
       ``(B) The participant or beneficiary (or authorized 
     representative).
       ``(C) The health care professional that provides the items 
     of services involved in the denial.
       ``(D) The institution at which the items or services (or 
     treatment) involved in the denial are provided.
       ``(E) The manufacturer of any drug or other item that is 
     included in the items or services involved in the denial.
       ``(F) Any other party determined under any regulations to 
     have a substantial interest in the denial involved.
       ``(h) Qualified External Review Entities.--
       ``(1) Selection of qualified external review entities.--
       ``(A) Limitation on plan or issuer selection.--The 
     Secretary shall implement procedures with respect to the 
     selection of qualified external review entities by a plan or 
     issuer to assure that the selection process among qualified 
     external review entities will not create any incentives for 
     external review entities to make a decision in a biased 
     manner.
       ``(B) State authority with respect to qualified external 
     review entities for health insurance issuers.--With respect 
     to health insurance issuers offering health insurance 
     coverage in connection with a group health plan in a State, 
     the State may, pursuant to a State law that is enacted after 
     the date of enactment of the Patients' Bill of Rights Plus 
     Act, provide for the designation or selection of qualified 
     external review entities in a manner determined by the State 
     to assure an unbiased determination in conducting external 
     review activities. In conducting reviews under this section, 
     an entity designated or selected under this subparagraph 
     shall comply with the provision of this section.
       ``(2) Contract with qualified external review entity.--
     Except as provided in paragraph (1)(B), the external review 
     process of a plan or issuer under this section shall be 
     conducted under a contract between the plan or issuer and 1 
     or more qualified external review entities (as defined in 
     paragraph (4)(A)).
       ``(3) Terms and conditions of contract.--The terms and 
     conditions of a contract under paragraph (2) shall--
       ``(A) be consistent with the standards the Secretary shall 
     establish to assure there is no real or apparent conflict of 
     interest in the conduct of external review activities; and
       ``(B) provide that the costs of the external review process 
     shall be borne by the plan or issuer.
     Subparagraph (B) shall not be construed as applying to the 
     imposition of a filing fee under subsection (b)(2)(A)(iv) or 
     costs incurred by the participant or beneficiary (or 
     authorized representative) or treating health care 
     professional (if any) in support of the review, including the 
     provision of additional evidence or information.
       ``(4) Qualifications.--
       ``(A) In general.--In this section, the term `qualified 
     external review entity' means, in relation to a plan or 
     issuer, an entity that is initially certified (and 
     periodically recertified) under subparagraph (C) as meeting 
     the following requirements:
       ``(i) The entity has (directly or through contracts or 
     other arrangements) sufficient medical, legal, and other 
     expertise and sufficient staffing to carry out duties of a 
     qualified external review entity under this section on a 
     timely basis, including making determinations under 
     subsection (b)(2)(A) and providing for independent medical 
     reviews under subsection (d).
       ``(ii) The entity is not a plan or issuer or an affiliate 
     or a subsidiary of a plan or issuer, and is not an affiliate 
     or subsidiary of a professional or trade association of plans 
     or issuers or of health care providers.
       ``(iii) The entity has provided assurances that it will 
     conduct external review activities consistent with the 
     applicable requirements of this section and standards 
     specified in subparagraph (C), including that it will not 
     conduct any external review activities in a case unless the 
     independence requirements of subparagraph (B) are met with 
     respect to the case.
       ``(iv) The entity has provided assurances that it will 
     provide information in a timely manner under subparagraph 
     (D).
       ``(v) The entity meets such other requirements as the 
     Secretary provides by regulation.
       ``(B) Independence requirements.--
       ``(i) In general.--Subject to clause (ii), an entity meets 
     the independence requirements of this subparagraph with 
     respect to any case if the entity--

       ``(I) is not a related party (as defined in subsection 
     (g)(7));
       ``(II) does not have a material familial, financial, or 
     professional relationship with such a party; and
       ``(III) does not otherwise have a conflict of interest with 
     such a party (as determined under regulations).

       ``(ii) Exception for reasonable compensation.--Nothing in 
     clause (i) shall be construed to prohibit receipt by a 
     qualified external review entity of compensation from a plan 
     or issuer for the conduct of external review activities under 
     this section if the compensation is provided consistent with 
     clause (iii).
       ``(iii) Limitations on entity compensation.--Compensation 
     provided by a plan or issuer to a qualified external review 
     entity in connection with reviews under this section shall--

       ``(I) not exceed a reasonable level; and
       ``(II) not be contingent on the decision rendered by the 
     entity or by any independent medical reviewer.

       ``(C) Certification and recertification process.--
       ``(i) In general.--The initial certification and 
     recertification of a qualified external review entity shall 
     be made--

       ``(I) under a process that is recognized or approved by the 
     Secretary; or
       ``(II) by a qualified private standard-setting organization 
     that is approved by the Secretary under clause (iii).

       ``(ii) Process.--The Secretary shall not recognize or 
     approve a process under clause (i)(I) unless the process 
     applies standards (as promulgated in regulations) that ensure 
     that a qualified external review entity--

       ``(I) will carry out (and has carried out, in the case of 
     recertification) the responsibilities of such an entity in 
     accordance with this section, including meeting applicable 
     deadlines;
       ``(II) will meet (and has met, in the case of 
     recertification) appropriate indicators of fiscal integrity;

       ``(III) will maintain (and has maintained, in the case of 
     recertification) appropriate confidentiality with respect to 
     individually identifiable health information obtained in the 
     course of conducting external review activities; and
       ``(IV) in the case recertification, shall review the 
     matters described in clause (iv).

       ``(iii) Approval of qualified private standard-setting 
     organizations.--For purposes of clause (i)(II), the Secretary 
     may approve a qualified private standard-setting organization 
     if the Secretary finds that the organization only certifies 
     (or recertifies) external review entities that meet at least 
     the standards required for the certification (or 
     recertification) of external review entities under clause 
     (ii).
       ``(iv) Considerations in recertifications.--In conducting 
     recertifications of a qualified external review entity under 
     this paragraph, the Secretary or organization conducting the 
     recertification shall review compliance of the entity with 
     the requirements for conducting external review activities 
     under this section, including the following:

       ``(I) Provision of information under subparagraph (D).
       ``(II) Adherence to applicable deadlines (both by the 
     entity and by independent medical reviewers it refers cases 
     to).
       ``(III) Compliance with limitations on compensation (with 
     respect to both the entity and independent medical reviewers 
     it refers cases to).

[[Page 13044]]

       ``(IV) Compliance with applicable independence 
     requirements.

       ``(v) Period of certification or recertification.--A 
     certification or recertification provided under this 
     paragraph shall extend for a period not to exceed 5 years.
       ``(vi) Revocation.--A certification or recertification 
     under this paragraph may be revoked by the Secretary or by 
     the organization providing such certification upon a showing 
     of cause.
       ``(D) Provision of information.--
       ``(i) In general.--A qualified external review entity shall 
     provide to the Secretary, in such manner and at such times as 
     the Secretary may require, such information (relating to the 
     denials which have been referred to the entity for the 
     conduct of external review under this section) as the 
     Secretary determines appropriate to assure compliance with 
     the independence and other requirements of this section to 
     monitor and assess the quality of its external review 
     activities and lack of bias in making determinations. Such 
     information shall include information described in clause 
     (ii) but shall not include individually identifiable medical 
     information.
       ``(ii) Information to be included.--The information 
     described in this subclause with respect to an entity is as 
     follows:

       ``(I) The number and types of denials for which a request 
     for review has been received by the entity.
       ``(II) The disposition by the entity of such denials, 
     including the number referred to a independent medical 
     reviewer and the reasons for such dispositions (including the 
     application of exclusions), on a plan or issuer-specific 
     basis and on a health care specialty-specific basis.
       ``(III) The length of time in making determinations with 
     respect to such denials.
       ``(IV) Updated information on the information required to 
     be submitted as a condition of certification with respect to 
     the entity's performance of external review activities.

       ``(iii) Information to be provided to certifying 
     organization.--

       ``(I) In general.--In the case of a qualified external 
     review entity which is certified (or recertified) under this 
     subsection by a qualified private standard-setting 
     organization, at the request of the organization, the entity 
     shall provide the organization with the information provided 
     to the Secretary under clause (i).
       ``(II) Additional information.--Nothing in this 
     subparagraph shall be construed as preventing such an 
     organization from requiring additional information as a 
     condition of certification or recertification of an entity.

       ``(iv) Use of information.--Information provided under this 
     subparagraph may be used by the Secretary and qualified 
     private standard-setting organizations to conduct oversight 
     of qualified external review entities, including 
     recertification of such entities, and shall be made available 
     to the public in an appropriate manner.
       ``(E) Limitation on liability.--No qualified external 
     review entity having a contract with a plan or issuer, and no 
     person who is employed by any such entity or who furnishes 
     professional services to such entity (including as an 
     independent medical reviewer), shall be held by reason of the 
     performance of any duty, function, or activity required or 
     authorized pursuant to this section, to be civilly liable 
     under any law of the United States or of any State (or 
     political subdivision thereof) if there was no actual malice 
     or gross misconduct in the performance of such duty, 
     function, or activity.
       ``(i) Definitions.--In this section:
       ``(1) Authorized representative.--The term `authorized 
     representative' means, with respect to a participant or 
     beneficiary--
       ``(A) a person to whom a participant or beneficiary has 
     given express written consent to represent the participant or 
     beneficiary in any proceeding under this section;
       ``(B) a person authorized by law to provide substituted 
     consent for the participant or beneficiary; or
       ``(C) a family member of the participant or beneficiary (or 
     the estate of the participant or beneficiary) or the 
     participant's or beneficiary's treating health care 
     professional when the participant or beneficiary is unable to 
     provide consent.
       ``(2) Claim for benefits.--The term `claim for benefits' 
     means any request by a participant or beneficiary (or 
     authorized representative) for benefits (including requests 
     that are subject to authorization of coverage or utilization 
     review), for eligibility, or for payment in whole or in part, 
     for an item or service under a group health plan or health 
     insurance coverage offered by a health insurance issuer in 
     connection with a group health plan.
       ``(3) Group health plan.--The term `group health plan' 
     shall have the meaning given such term in section 733(a). In 
     applying this paragraph, excepted benefits described in 
     section 733(c) shall not be treated as benefits consisting of 
     medical care.
       ``(4) Health insurance coverage.--The term `health 
     insurance coverage' has the meaning given such term in 
     section 733(b)(1). In applying this paragraph, excepted 
     benefits described in section 733(c) shall not be treated as 
     benefits consisting of medical care.
       ``(5) Health insurance issuer.--The term `health insurance 
     issuer' has the meaning given such term in section 733(b)(2).
       ``(6) Prior authorization determination.--The term `prior 
     authorization determination' means a determination by the 
     group health plan or health insurance issuer offering health 
     insurance coverage in connection with a group health plan 
     prior to the provision of the items and services as a 
     condition of coverage of the items and services under the 
     terms and conditions of the plan or coverage.
       ``(7) Treating health care professional.--The term 
     `treating health care professional' with respect to a group 
     health plan, health insurance issuer or provider sponsored 
     organization means a physician (medical doctor or doctor of 
     osteopathy) or other health care practitioner who is acting 
     within the scope of his or her State licensure or 
     certification for the delivery of health care services and 
     who is primarily responsible for delivering those services to 
     the participant or beneficiary.
       ``(8) Utilization review.--The term `utilization review' 
     with respect to a group health plan or health insurance 
     coverage means procedures used in the determination of 
     coverage for a participant or beneficiary, such as procedures 
     to evaluate the medical necessity, appropriateness, efficacy, 
     quality, or efficiency of health care services, procedures or 
     settings, and includes prospective review, concurrent review, 
     second opinions, case management, discharge planning, or 
     retrospective review.''.
       (b) Conforming Amendment.--The table of contents in section 
     1 of the Employee Retirement Income Security Act of 1974 is 
     amended by inserting after the item relating to section 503 
     the following:

``Sec. 503A. Claims and internal appeals procedures for group health 
              plans.
``Sec. 503B. Independent external appeals procedures for group health 
              plans.''.

       (c) Effective Date.--The amendments made by this section 
     shall apply with respect to plan years beginning on or after 
     2 years after the date of enactment of this Act. The 
     Secretary shall issue all regulations necessary to carry out 
     the amendments made by this section before the effective date 
     thereof.

     SEC. 222. ENFORCEMENT.

       Section 502(c) of the Employee Retirement Income Security 
     Act of 1974 (29 U.S.C. 1132(c)) is amended by adding at the 
     end the following:
       ``(8) The Secretary may assess a civil penalty against any 
     plan of up to $10,000 for the plan's failure or refusal to 
     comply with any deadline applicable under section 503B or any 
     determination under such section, except that in any case in 
     which treatment was not commenced by the plan in accordance 
     with the determination of an independent external reviewer, 
     the Secretary shall assess a civil penalty of $10,000 against 
     the plan and the plan shall pay such penalty to the 
     participant or beneficiary involved.''.

                          Subtitle D--Remedies

     SEC. 231. AVAILABILITY OF COURT REMEDIES.

       (a) In General.--Section 502 of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1132) is amended by 
     adding at the end the following:
       ``(n) Cause of Action Relating to Denial of a Claim for 
     Health Benefits.--
       ``(1) In general.--
       ``(A) Failure to comply with external medical review.--In 
     any case in which--
       ``(i) a designated decision-maker described in paragraph 
     (2) fails to exercise ordinary care in approving coverage 
     pursuant to the written determination of an independent 
     medical reviewer under section 503B(d)(3)(F) that reverses a 
     denial of a claim for benefits; and
       ``(ii) the failure described in clause (i) is the proximate 
     cause of substantial harm to, or the wrongful death of, the 
     participant or beneficiary;
     such designated decision-maker shall be liable to the 
     participant or beneficiary (or the estate of such participant 
     or beneficiary) for economic and noneconomic damages in 
     connection with such failure and such injury or death 
     (subject to paragraph (4)).
       ``(B) Wrongful determination resulting in delay in 
     providing benefits.--In any case in which--
       ``(i) a designated decision-maker described in paragraph 
     (2) acts in bad faith in making a final determination denying 
     a claim for benefits under section 503A(b);
       ``(ii) the denial described in clause (i) is reversed by an 
     independent medical reviewer under section 503B(d); and
       ``(iii) the delay attributable to the failure described in 
     clause (i) is the proximate cause of substantial harm to, or 
     the wrongful death of, the participant or beneficiary;
     such designated decision-maker shall be liable to the 
     participant or beneficiary (or the estate of such participant 
     or beneficiary) for economic and noneconomic damages in 
     connection with such failure and such injury or death 
     (subject to paragraph (4)).
       ``(2) Designated decision-makers for purposes of 
     liability.--An employer or plan sponsor shall not be liable 
     under any cause of action described in paragraph (1) if the 
     employer or plan sponsor complies with the following 
     provisions:
       ``(A) Appointment.--A group health plan may designate one 
     or more persons to serve

[[Page 13045]]

     as the designated decision-maker for purposes of paragraph 
     (1). Such designated decision-makers shall have the exclusive 
     authority under the group health plan (or under the health 
     insurance coverage in the case of a health insurance issuer 
     offering coverage in connection with a group health plan) to 
     make determinations described in section 503A with respect to 
     claims for benefits and determination to approve coverage 
     pursuant to written determination of independent medical 
     reviewers under section 503B, except that the plan documents 
     may expressly provide that the designated decision-maker is 
     subject to the direction of a named fiduciary.
       ``(B) Procedures.--A designated decision-maker shall--
       ``(i) be a person who is named in the plan or coverage 
     documents, or who, pursuant to procedures specified in the 
     plan or coverage documents, is identified as the designated 
     decision-maker by--

       ``(I) a person who is an employer or employee organization 
     with respect to the plan or issuer;
       ``(II) a person who is such an employer and such an 
     employee organization acting jointly; or
       ``(III) a person who is a named fiduciary;

       ``(ii) agree to accept appointment as a designated 
     decision-maker; and
       ``(iii) be identified in the plan or coverage documents as 
     required under section 714(b)(14).
       ``(C) Qualifications.--To be appointed as a designated 
     decision-maker under this paragraph, a person shall be--
       ``(i) a plan sponsor;
       ``(ii) a group health plan;
       ``(iii) a health insurance issuer; or
       ``(iv) any other person who can provide adequate evidence, 
     in accordance with regulations promulgated by the Secretary, 
     of the ability of the person to--

       ``(I) carry out the responsibilities set forth in the plan 
     or coverage documents;
       ``(II) carry out the applicable requirements of this 
     subsection; and
       ``(III) meet other applicable requirements under this Act, 
     including any financial obligation for liability under this 
     subsection.

       ``(D) Flexibility in administration.--A group health plan, 
     or health insurance issuer offering coverage in connection 
     with a group health plan, may provide--
       ``(i) that any person or group of persons may serve in more 
     than one capacity with respect to the plan or coverage 
     (including service as a designated decision-maker, 
     administrator, and named fiduciary); or
       ``(ii) that a designated decision-maker may employ one or 
     more persons to provide advice with respect to any 
     responsibility of such decision-maker under the plan or 
     coverage.
       ``(E) Failure to designate.--In any case in which a 
     designated decision-maker is not appointed under this 
     paragraph, the group health plan (or health insurance issuer 
     offering coverage in connection with the group health plan), 
     the administrator, or the party or parties that bears the 
     sole responsibility for making the final determination under 
     section 503A(b) (with respect to an internal review), or for 
     approving coverage pursuant to the written determination of 
     an independent medical reviewer under section 503B, with 
     respect to a denial of a claim for benefits shall be treated 
     as the designated decision-maker for purposes of liability 
     under this section.
       ``(3) Requirement of exhaustion of independent medical 
     review.--Paragraph (1) shall apply only if a final 
     determination denying a claim for benefits under section 
     503A(b) has been referred for independent medical review 
     under section 503B(d) and a written determination by an 
     independent medical reviewer to reverse such final 
     determination has been issued with respect to such review.
       ``(4) Limitations on recovery of damages.--
       ``(A) Maximum award of noneconomic damages.--The aggregate 
     amount of liability for noneconomic loss in an action under 
     paragraph (1) may not exceed $350,000.
       ``(B) Increase in amount.--The amount referred to in 
     subparagraph (A) shall be increased or decreased, for each 
     calendar year that ends after December 31, 2001, by the same 
     percentage as the percentage by which the Consumer Price 
     Index for All Urban Consumers (United States city average), 
     published by the Bureau of Labor Statistics, for September of 
     the preceding calendar year has increased or decreased from 
     the such Index for September of 2001.
       ``(C) Joint and several liability.--In the case of any 
     action commenced pursuant to paragraph (1), the defendant 
     shall be liable only for the amount of noneconomic damages 
     attributable to such defendant in direct proportion to such 
     defendant's share of fault or responsibility for the injury 
     suffered by the participant or beneficiary. In all such 
     cases, the liability of a defendant for noneconomic damages 
     shall be several and not joint.
       ``(D) Treatment of collateral source payments.--
       ``(i) In general.--In the case of any action commenced 
     pursuant to paragraph (1), the total amount of damages 
     received by a participant or beneficiary under such action 
     shall be reduced, in accordance with clause (ii), by any 
     other payment that has been, or will be, made to such 
     participant or beneficiary to compensate such participant or 
     beneficiary for the injury that was the subject of such 
     action.
       ``(ii) Amount of reduction.--The amount by which an award 
     of damages to a participant or beneficiary for an injury 
     shall be reduced under clause (i) shall be--

       ``(I) the total amount of any payments (other than such 
     award) that have been made or that will be made to such 
     participant or beneficiary to pay costs of or compensate such 
     participant or beneficiary for the injury that was the 
     subject of the action; less
       ``(II) the amount paid by such participant or beneficiary 
     (or by the spouse, parent, or legal guardian of such 
     participant or beneficiary) to secure the payments described 
     in subclause (I).

       ``(iii) Determination of amounts from collateral sources.--
     The reduction required under clause (ii) shall be determined 
     by the court in a pretrial proceeding. At the subsequent 
     trial no evidence shall be admitted as to the amount of any 
     charge, payments, or damage for which a participant or 
     beneficiary--

       ``(I) has received payment from a collateral source or the 
     obligation for which has been assured by a third party; or
       ``(II) is, or with reasonable certainty, will be eligible 
     to receive from a collateral source which will, with 
     reasonable certainty, be assumed by a third party.

       ``(5) Affirmative defenses.--In the case of any cause of 
     action under paragraph (1), it shall be an affirmative 
     defense that--
       ``(A) the group health plan, or health insurance issuer 
     offering health insurance coverage in connection with a group 
     health plan, involved did not receive from the participant or 
     beneficiary (or authorized representative) or the treating 
     health care professional (if any), sufficient information 
     regarding the medical condition of the participant or 
     beneficiary that was necessary to make a final determination 
     on a claim for benefits under section 503A(b);
       ``(B) the participant or beneficiary (or authorized 
     representative)--
       ``(i) was in possession of facts that were sufficient to 
     enable the participant or beneficiary (or authorized 
     representative) to know that an expedited review under 
     section 503A or 503B would have prevented the harm that is 
     the subject of the action; and
       ``(ii) failed to notify the plan or issuer of the need for 
     such an expedited review; or
       ``(C) the cause of action is based solely on the failure of 
     a qualified external review entity or an independent medical 
     reviewer to meet the timelines applicable under section 503B.
     Nothing in this paragraph shall be construed to limit the 
     application of any other affirmative defense that may be 
     applicable to the cause of action involved.
       ``(6) Waiver of internal review.--In the case of any cause 
     of action under paragraph (1), the waiver or nonwaiver of 
     internal review under section 503A(b)(1)(D) by the group 
     health plan, or health insurance issuer offering health 
     insurance coverage in connection with a group health plan, 
     shall not be used in determining liability.
       ``(7) Limitations on actions.--Paragraph (1) shall not 
     apply in connection with any action that is commenced more 
     than 1 year after--
       ``(A) the date on which the last act occurred which 
     constituted a part of the failure referred to in such 
     paragraph; or
       ``(B) in the case of an omission, the last date on which 
     the decision-maker could have cured the failure.
       ``(8) Limitation on relief where defendant's position 
     previously supported upon external review.--In any case in 
     which the court finds the defendant to be liable in an action 
     under this subsection, to the extent that such liability is 
     based on a finding by the court of a particular failure 
     described in paragraph (1) and such finding is contrary to a 
     previous determination by an independent medical reviewer 
     under section 503B(d) with respect to such defendant, no 
     relief shall be available under this subsection in addition 
     to the relief otherwise available under subsection (a)(1)(B).
       ``(9) Construction.--Nothing in this subsection shall be 
     construed as authorizing a cause of action under paragraph 
     (1) for--
       ``(A) the failure of a group health plan or health 
     insurance issuer to provide an item or service that is 
     specifically excluded under the plan or coverage; or
       ``(B) any denial of a claim for benefits that was not 
     eligible for independent medical review under section 
     503B(d).
       ``(10) Federal jurisdiction.--In the case of any action 
     commenced pursuant to paragraph (1) the district courts of 
     the United States shall have exclusive jurisdiction.
       ``(11) Definitions.--In this subsection:
       ``(A) Authorized representative.--The term `authorized 
     representative' has the meaning given such term in section 
     503B(i).
       ``(B) Claim for benefits.--The term `claim for benefits' 
     shall have the meaning given such term in section 503B(i), 
     except that such term shall only include claims for prior 
     authorization determinations (as such term is defined in 
     section 503B(i)).
       ``(C) Group health plan.--The term `group health plan' 
     shall have the meaning given such term in section 733(a).

[[Page 13046]]

       ``(D) Health insurance coverage.--The term `health 
     insurance coverage' has the meaning given such term in 
     section 733(b)(1).
       ``(E) Health insurance issuer.--The term `health insurance 
     issuer' has the meaning given such term in section 733(b)(2) 
     (including health maintenance organizations as defined in 
     section 733(b)(3)).
       ``(F) Ordinary care.--The term `ordinary care' means the 
     care, skill, prudence, and diligence under the circumstances 
     prevailing at the time the care is provided that a prudent 
     individual acting in a like capacity and familiar with the 
     care being provided would use in providing care of a similar 
     character.
       ``(G) Substantial harm.--The term `substantial harm' means 
     the loss of life, loss or significant impairment of limb or 
     bodily function, significant disfigurement, or severe and 
     chronic physical pain.
       ``(12) Effective date.--The provisions of this subsection 
     shall apply to acts and omissions occurring on or after the 
     date of enactment of this subsection.''.
       (b) Immunity from Liability for Provision of Insurance 
     Options.--
       (1) In general.--Section 502 of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1132), as amended by 
     subsection (a), is further amended by adding at the end the 
     following:
       ``(o) Immunity from Liability for Provision of Insurance 
     Options.--
       ``(1) In general.--No liability shall arise under 
     subsection (n) with respect to a participant or beneficiary 
     against a group health plan (other than a fully insured group 
     health plan) if such plan offers the participant or 
     beneficiary the coverage option described in paragraph (2).
       ``(2) Coverage option.--The coverage option described in 
     this paragraph is one under which the group health plan 
     (other than a fully insured group health plan), at the time 
     of enrollment or as provided for in paragraph (3), provides 
     the participant or beneficiary with the option to--
       ``(A) enroll for coverage under a fully insured health 
     plan; or
       ``(B) receive an individual benefit payment, in an amount 
     equal to the amount that would be contributed on behalf of 
     the participant or beneficiary by the plan sponsor for 
     enrollment in the group health plan, for use by the 
     participant or beneficiary in obtaining health insurance 
     coverage in the individual market.
       ``(3) Time of offering of option.--The coverage option 
     described in paragraph (2) shall be offered to a participant 
     or beneficiary--
       ``(A) during the first period in which the individual is 
     eligible to enroll under the group health plan; or
       ``(B) during any special enrollment period provided by the 
     group health plan after the date of enactment of the 
     Patients' Bill of Rights Plus Act for purposes of offering 
     such coverage option.''.
       (2) Amendments to Internal Revenue Code.--
       (A) Exclusion from income.--Section 106 of the Internal 
     Revenue Code of 1986 (relating to contributions by employer 
     to accident and health plans) is amended by adding at the end 
     the following:
       ``(d) Treatment of Certain Coverage Option Under Self-
     Insured Plans.--No amount shall be included in the gross 
     income of an individual by reason of--
       ``(1) the individual's right to elect a coverage option 
     described in section 502(o)(2) of the Employee Retirement 
     Income Security Act of 1974, or
       ``(2) the receipt by the individual of an individual 
     benefit payment described in section 502(o)(2)(A) of such 
     Act.''
       (B) Nondiscrimination rules.--Section 105(h) of such Code 
     (relating to self-insured medical expense reimbursement 
     plans) is amended by adding at the end the following:
       ``(11) Treatment of certain coverage options.--If a self-
     insured medical reimbursement plan offers the coverage option 
     described in section 502(o)(2) of the Employee Retirement 
     Income Security Act of 1974, employees who elect such option 
     shall be treated as eligible to benefit under the plan and 
     the plan shall be treated as benefiting such employees.''
       (c) Conforming Amendment.--Section 502(a)(1)(A) of the 
     Employee Retirement Income Security Act of 1974 (29 U.S.C. 
     1132(a)(1)(A)) is amended by inserting ``or (n)'' after 
     ``subsection (c)''.

     SEC. 232. LIMITATION ON CERTAIN CLASS ACTION LITIGATION.

       (a) ERISA.--Section 502 of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1132), as amended by section 
     231, is further amended by adding at the end the following:
       ``(p) Limitation on Class Action Litigation.--A claim or 
     cause of action under section 502(n) may not be maintained as 
     a class action.''.
       (b) RICO.--Section 1964(c) of title 18, United States Code, 
     is amended--
       (1) by inserting ``(1)'' after the subsection designation; 
     and
       (2) by adding at the end the following:
       ``(2) No action may be brought under this subsection, or 
     alleging any violation of section 1962, against any person 
     where the action seeks relief for which a remedy may be 
     provided under section 502 of the Employee Retirement Income 
     Security Act of 1974.''.
       (c) Effective Date.--
       (1) In general.--The amendments made by this section shall 
     apply to all civil actions that are filed on or after the 
     date of enactment of this Act.
       (2) Pending civil actions.--Notwithstanding section 502(p) 
     of the Employee Retirement Income Security Act of 1974 and 
     section 1964(c)(2) of title 18, United States Code, such 
     sections 502(p) and 1964(c)(2) shall apply to civil actions 
     that are pending and have not been finally determined by 
     judgment or settlement prior to the date of enactment of this 
     Act if such actions are substantially similar in nature to 
     the claims or causes of actions referred to in such sections 
     502(p) and 1964(c)(2).

     SEC. 233. SEVERABILITY.

       If any provision of this subtitle, an amendment made by 
     this subtitle, or the application of such provision or 
     amendment to any person or circumstance is held to be 
     unconstitutional, the remainder of this subtitle, the 
     amendments made by this subtitle, and the application of the 
     provisions of such to any person or circumstance shall not be 
     affected thereby.

              TITLE III--WOMEN'S HEALTH AND CANCER RIGHTS

     SEC. 301. WOMEN'S HEALTH AND CANCER RIGHTS.

       (a) Short Title.--This section may be cited as the 
     ``Women's Health and Cancer Rights Act of 2000''.
       (b) Findings.--Congress finds that--
       (1) the offering and operation of health plans affect 
     commerce among the States;
       (2) health care providers located in a State serve patients 
     who reside in the State and patients who reside in other 
     States; and
       (3) in order to provide for uniform treatment of health 
     care providers and patients among the States, it is necessary 
     to cover health plans operating in 1 State as well as health 
     plans operating among the several States.
       (c) Amendments to ERISA.--
       (1) In general.--Subpart B of part 7 of subtitle B of title 
     I of the Employee Retirement Income Security Act of 1974, as 
     amended by section 211(a), is further amended by adding at 
     the end the following:

     ``SEC. 715. REQUIRED COVERAGE FOR MINIMUM HOSPITAL STAY FOR 
                   MASTECTOMIES AND LYMPH NODE DISSECTIONS FOR THE 
                   TREATMENT OF BREAST CANCER AND COVERAGE FOR 
                   SECONDARY CONSULTATIONS.

       ``(a) Inpatient Care.--
       ``(1) In general.--A group health plan, and a health 
     insurance issuer providing health insurance coverage in 
     connection with a group health plan, that provides medical 
     and surgical benefits shall ensure that inpatient coverage 
     with respect to the treatment of breast cancer is provided 
     for a period of time as is determined by the attending 
     physician, in consultation with the patient, to be medically 
     necessary and appropriate following--
       ``(A) a mastectomy;
       ``(B) a lumpectomy; or
       ``(C) a lymph node dissection for the treatment of breast 
     cancer.
       ``(2) Exception.--Nothing in this section shall be 
     construed as requiring the provision of inpatient coverage if 
     the attending physician and patient determine that a shorter 
     period of hospital stay is medically appropriate.
       ``(b) Prohibition on Certain Modifications.--In 
     implementing the requirements of this section, a group health 
     plan, and a health insurance issuer providing health 
     insurance coverage in connection with a group health plan, 
     may not modify the terms and conditions of coverage based on 
     the determination by a participant or beneficiary to request 
     less than the minimum coverage required under subsection (a).
       ``(c) Notice.--A group health plan, and a health insurance 
     issuer providing health insurance coverage in connection with 
     a group health plan shall provide notice to each participant 
     and beneficiary under such plan regarding the coverage 
     required by this section in accordance with regulations 
     promulgated by the Secretary. Such notice shall be in writing 
     and prominently positioned in any literature or 
     correspondence made available or distributed by the plan or 
     issuer and shall be transmitted--
       ``(1) in the next mailing made by the plan or issuer to the 
     participant or beneficiary;
       ``(2) as part of any yearly informational packet sent to 
     the participant or beneficiary; or
       ``(3) not later than January 1, 2001;
     whichever is earlier.
       ``(d) Secondary Consultations.--
       ``(1) In general.--A group health plan, and a health 
     insurance issuer providing health insurance coverage in 
     connection with a group health plan, that provides coverage 
     with respect to medical and surgical services provided in 
     relation to the diagnosis and treatment of cancer shall 
     ensure that full coverage is provided for secondary 
     consultations by specialists in the appropriate medical 
     fields (including pathology, radiology, and oncology) to 
     confirm or refute such diagnosis. Such plan or issuer shall 
     ensure that full coverage is provided for such secondary 
     consultation whether such consultation is based on a positive 
     or negative initial diagnosis. In any case in which the 
     attending physician certifies in writing that services 
     necessary for such a secondary consultation

[[Page 13047]]

     are not sufficiently available from specialists operating 
     under the plan with respect to whose services coverage is 
     otherwise provided under such plan or by such issuer, such 
     plan or issuer shall ensure that coverage is provided with 
     respect to the services necessary for the secondary 
     consultation with any other specialist selected by the 
     attending physician for such purpose at no additional cost to 
     the individual beyond that which the individual would have 
     paid if the specialist was participating in the network of 
     the plan.
       ``(2) Exception.--Nothing in paragraph (1) shall be 
     construed as requiring the provision of secondary 
     consultations where the patient determines not to seek such a 
     consultation.
       ``(e) Prohibition on Penalties or Incentives.--A group 
     health plan, and a health insurance issuer providing health 
     insurance coverage in connection with a group health plan, 
     may not--
       ``(1) penalize or otherwise reduce or limit the 
     reimbursement of a provider or specialist because the 
     provider or specialist provided care to a participant or 
     beneficiary in accordance with this section;
       ``(2) provide financial or other incentives to a physician 
     or specialist to induce the physician or specialist to keep 
     the length of inpatient stays of patients following a 
     mastectomy, lumpectomy, or a lymph node dissection for the 
     treatment of breast cancer below certain limits or to limit 
     referrals for secondary consultations; or
       ``(3) provide financial or other incentives to a physician 
     or specialist to induce the physician or specialist to 
     refrain from referring a participant or beneficiary for a 
     secondary consultation that would otherwise be covered by the 
     plan or coverage involved under subsection (d).''.
       (2) Clerical amendment.--The table of contents in section 1 
     of the Employee Retirement Income Security Act of 1974 is 
     amended by inserting after the item relating to section 714 
     the following new item:

``Sec. 715. Required coverage for minimum hospital stay for 
              mastectomies and lymph node dissections for the treatment 
              of breast cancer and coverage for secondary 
              consultations.''.

       (d) Amendments to PHSA Relating to the Group Market.--
     Subpart 2 of part A of title XXVII of the Public Health 
     Service Act (42 U.S.C. 300gg-4 et seq.) is amended by adding 
     at the end the following new section:

     ``SEC. 2707. REQUIRED COVERAGE FOR MINIMUM HOSPITAL STAY FOR 
                   MASTECTOMIES AND LYMPH NODE DISSECTIONS FOR THE 
                   TREATMENT OF BREAST CANCER AND COVERAGE FOR 
                   SECONDARY CONSULTATIONS.

       ``(a) Inpatient Care.--
       ``(1) In general.--A group health plan, and a health 
     insurance issuer providing health insurance coverage in 
     connection with a group health plan, that provides medical 
     and surgical benefits shall ensure that inpatient coverage 
     with respect to the treatment of breast cancer is provided 
     for a period of time as is determined by the attending 
     physician, in consultation with the patient, to be medically 
     necessary and appropriate following--
       ``(A) a mastectomy;
       ``(B) a lumpectomy; or
       ``(C) a lymph node dissection for the treatment of breast 
     cancer.
       ``(2) Exception.--Nothing in this section shall be 
     construed as requiring the provision of inpatient coverage if 
     the attending physician and patient determine that a shorter 
     period of hospital stay is medically appropriate.
       ``(b) Prohibition on Certain Modifications.--In 
     implementing the requirements of this section, a group health 
     plan, and a health insurance issuer providing health 
     insurance coverage in connection with a group health plan, 
     may not modify the terms and conditions of coverage based on 
     the determination by a participant or beneficiary to request 
     less than the minimum coverage required under subsection (a).
       ``(c) Notice.--A group health plan, and a health insurance 
     issuer providing health insurance coverage in connection with 
     a group health plan shall provide notice to each participant 
     and beneficiary under such plan regarding the coverage 
     required by this section in accordance with regulations 
     promulgated by the Secretary. Such notice shall be in writing 
     and prominently positioned in any literature or 
     correspondence made available or distributed by the plan or 
     issuer and shall be transmitted--
       ``(1) in the next mailing made by the plan or issuer to the 
     participant or beneficiary;
       ``(2) as part of any yearly informational packet sent to 
     the participant or beneficiary; or
       ``(3) not later than January 1, 2001;
     whichever is earlier.
       ``(d) Secondary Consultations.--
       ``(1) In general.--A group health plan, and a health 
     insurance issuer providing health insurance coverage in 
     connection with a group health plan that provides coverage 
     with respect to medical and surgical services provided in 
     relation to the diagnosis and treatment of cancer shall 
     ensure that full coverage is provided for secondary 
     consultations by specialists in the appropriate medical 
     fields (including pathology, radiology, and oncology) to 
     confirm or refute such diagnosis. Such plan or issuer shall 
     ensure that full coverage is provided for such secondary 
     consultation whether such consultation is based on a positive 
     or negative initial diagnosis. In any case in which the 
     attending physician certifies in writing that services 
     necessary for such a secondary consultation are not 
     sufficiently available from specialists operating under the 
     plan with respect to whose services coverage is otherwise 
     provided under such plan or by such issuer, such plan or 
     issuer shall ensure that coverage is provided with respect to 
     the services necessary for the secondary consultation with 
     any other specialist selected by the attending physician for 
     such purpose at no additional cost to the individual beyond 
     that which the individual would have paid if the specialist 
     was participating in the network of the plan.
       ``(2) Exception.--Nothing in paragraph (1) shall be 
     construed as requiring the provision of secondary 
     consultations where the patient determines not to seek such a 
     consultation.
       ``(e) Prohibition on Penalties or Incentives.--A group 
     health plan, and a health insurance issuer providing health 
     insurance coverage in connection with a group health plan, 
     may not--
       ``(1) penalize or otherwise reduce or limit the 
     reimbursement of a provider or specialist because the 
     provider or specialist provided care to a participant or 
     beneficiary in accordance with this section;
       ``(2) provide financial or other incentives to a physician 
     or specialist to induce the physician or specialist to keep 
     the length of inpatient stays of patients following a 
     mastectomy, lumpectomy, or a lymph node dissection for the 
     treatment of breast cancer below certain limits or to limit 
     referrals for secondary consultations; or
       ``(3) provide financial or other incentives to a physician 
     or specialist to induce the physician or specialist to 
     refrain from referring a participant or beneficiary for a 
     secondary consultation that would otherwise be covered by the 
     plan or coverage involved under subsection (d).''.
       (e) Amendments to PHSA Relating to the Individual Market.--
     The first subpart 3 of part B of title XXVII of the Public 
     Health Service Act (42 U.S.C. 300gg-51 et seq.) (relating to 
     other requirements) (42 U.S.C. 300gg-51 et seq.) is amended--
       (1) by redesignating such subpart as subpart 2; and
       (2) by adding at the end the following:

     ``SEC. 2753. REQUIRED COVERAGE FOR MINIMUM HOSPITAL STAY FOR 
                   MASTECTOMIES AND LYMPH NODE DISSECTIONS FOR THE 
                   TREATMENT OF BREAST CANCER AND SECONDARY 
                   CONSULTATIONS.

       ``The provisions of section 2707 shall apply to health 
     insurance coverage offered by a health insurance issuer in 
     the individual market in the same manner as they apply to 
     health insurance coverage offered by a health insurance 
     issuer in connection with a group health plan in the small or 
     large group market.''.
       (f) Amendments to the IRC.--
       (1) In general.--Subchapter B of chapter 100 of the 
     Internal Revenue Code of 1986, as amended by section 202, is 
     further amended by inserting after section 9813 the 
     following:

     ``SEC. 9814. REQUIRED COVERAGE FOR MINIMUM HOSPITAL STAY FOR 
                   MASTECTOMIES AND LYMPH NODE DISSECTIONS FOR THE 
                   TREATMENT OF BREAST CANCER AND COVERAGE FOR 
                   SECONDARY CONSULTATIONS.

       ``(a) Inpatient Care.--
       ``(1) In general.--A group health plan that provides 
     medical and surgical benefits shall ensure that inpatient 
     coverage with respect to the treatment of breast cancer is 
     provided for a period of time as is determined by the 
     attending physician, in consultation with the patient, to be 
     medically necessary and appropriate following--
       ``(A) a mastectomy;
       ``(B) a lumpectomy; or
       ``(C) a lymph node dissection for the treatment of breast 
     cancer.
       ``(2) Exception.--Nothing in this section shall be 
     construed as requiring the provision of inpatient coverage if 
     the attending physician and patient determine that a shorter 
     period of hospital stay is medically appropriate.
       ``(b) Prohibition on Certain Modifications.--In 
     implementing the requirements of this section, a group health 
     plan may not modify the terms and conditions of coverage 
     based on the determination by a participant or beneficiary to 
     request less than the minimum coverage required under 
     subsection (a).
       ``(c) Notice.--A group health plan shall provide notice to 
     each participant and beneficiary under such plan regarding 
     the coverage required by this section in accordance with 
     regulations promulgated by the Secretary. Such notice shall 
     be in writing and prominently positioned in any literature or 
     correspondence made available or distributed by the plan and 
     shall be transmitted--
       ``(1) in the next mailing made by the plan to the 
     participant or beneficiary;
       ``(2) as part of any yearly informational packet sent to 
     the participant or beneficiary; or
       ``(3) not later than January 1, 2000;
     whichever is earlier.
       ``(d) Secondary Consultations.--
       ``(1) In general.--A group health plan that provides 
     coverage with respect to medical

[[Page 13048]]

     and surgical services provided in relation to the diagnosis 
     and treatment of cancer shall ensure that full coverage is 
     provided for secondary consultations by specialists in the 
     appropriate medical fields (including pathology, radiology, 
     and oncology) to confirm or refute such diagnosis. Such plan 
     or issuer shall ensure that full coverage is provided for 
     such secondary consultation whether such consultation is 
     based on a positive or negative initial diagnosis. In any 
     case in which the attending physician certifies in writing 
     that services necessary for such a secondary consultation are 
     not sufficiently available from specialists operating under 
     the plan with respect to whose services coverage is otherwise 
     provided under such plan or by such issuer, such plan or 
     issuer shall ensure that coverage is provided with respect to 
     the services necessary for the secondary consultation with 
     any other specialist selected by the attending physician for 
     such purpose at no additional cost to the individual beyond 
     that which the individual would have paid if the specialist 
     was participating in the network of the plan.
       ``(2) Exception.--Nothing in paragraph (1) shall be 
     construed as requiring the provision of secondary 
     consultations where the patient determines not to seek such a 
     consultation.
       ``(e) Prohibition on Penalties.--A group health plan may 
     not--
       ``(1) penalize or otherwise reduce or limit the 
     reimbursement of a provider or specialist because the 
     provider or specialist provided care to a participant or 
     beneficiary in accordance with this section;
       ``(2) provide financial or other incentives to a physician 
     or specialist to induce the physician or specialist to keep 
     the length of inpatient stays of patients following a 
     mastectomy, lumpectomy, or a lymph node dissection for the 
     treatment of breast cancer below certain limits or to limit 
     referrals for secondary consultations; or
       ``(3) provide financial or other incentives to a physician 
     or specialist to induce the physician or specialist to 
     refrain from referring a participant or beneficiary for a 
     secondary consultation that would otherwise be covered by the 
     plan involved under subsection (d).''.
       (2) Clerical amendment.--The table of contents for chapter 
     100 of such Code is amended by inserting after the item 
     relating to section 9813 the following new item:

``Sec. 9814. Required coverage for minimum hospital stay for 
              mastectomies and lymph node dissections for the treatment 
              of breast cancer and coverage for secondary 
              consultations.''.

               TITLE IV--GENETIC INFORMATION AND SERVICES

     SEC. 401. SHORT TITLE.

       This title may be cited as the ``Genetic Information 
     Nondiscrimination in Health Insurance Act of 1999''.

     SEC. 402. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY 
                   ACT OF 1974.

       (a) Prohibition of Health Discrimination on the Basis of 
     Genetic Information or Genetic Services.--
       (1) No enrollment restriction for genetic services.--
     Section 702(a)(1)(F) of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1182(a)(1)(F)) is amended by 
     inserting before the period the following: ``(including 
     information about a request for or receipt of genetic 
     services)''.
       (2) No discrimination in group premiums based on predictive 
     genetic information.--Subpart B of part 7 of subtitle B of 
     title I of the Employee Retirement Income Security Act of 
     1974, as amended by section 301(c), is further amended by 
     adding at the end the following:

     ``SEC. 716. PROHIBITING PREMIUM DISCRIMINATION AGAINST GROUPS 
                   ON THE BASIS OF PREDICTIVE GENETIC INFORMATION.

       ``A group health plan, or a health insurance issuer 
     offering group health insurance coverage in connection with a 
     group health plan, shall not adjust premium or contribution 
     amounts for a group on the basis of predictive genetic 
     information concerning any individual (including a dependent) 
     or family member of the individual (including information 
     about a request for or receipt of genetic services).''.
       (3) Conforming amendments.--
       (A) In general.--Section 702(b) of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1182(b)) is amended by 
     adding at the end the following:
       ``(3) Reference to related provision.--For a provision 
     prohibiting the adjustment of premium or contribution amounts 
     for a group under a group health plan on the basis of 
     predictive genetic information (including information about a 
     request for or receipt of genetic services), see section 
     716.''.
       (B) Table of contents.--The table of contents in section 1 
     of the Employee Retirement Income Security Act of 1974, as 
     amended by section 301, is further amended by inserting after 
     the item relating to section 715 the following new item:

``Sec. 716. Prohibiting premium discrimination against groups on the 
              basis of predictive genetic information.''.

       (b) Limitation on Collection of Predictive Genetic 
     Information.--Section 702 of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1182) is amended by adding at 
     the end the following:
       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     group health plan, or a health insurance issuer offering 
     health insurance coverage in connection with a group health 
     plan, shall not request or require predictive genetic 
     information concerning any individual (including a dependent) 
     or family member of the individual (including information 
     about a request for or receipt of genetic services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) In general.--Notwithstanding paragraph (1), a group 
     health plan, or a health insurance issuer offering health 
     insurance coverage in connection with a group health plan, 
     that provides health care items and services to an individual 
     or dependent may request (but may not require) that such 
     individual or dependent disclose, or authorize the collection 
     or disclosure of, predictive genetic information for purposes 
     of diagnosis, treatment, or payment relating to the provision 
     of health care items and services to such individual or 
     dependent.
       ``(B) Notice of confidentiality practices and description 
     of safeguards.--As a part of a request under subparagraph 
     (A), the group health plan, or a health insurance issuer 
     offering health insurance coverage in connection with a group 
     health plan, shall provide to the individual or dependent a 
     description of the procedures in place to safeguard the 
     confidentiality, as described in subsection (d), of such 
     predictive genetic information.
       ``(d) Confidentiality with Respect to Predictive Genetic 
     Information.--
       ``(1) Notice of confidentiality practices.--
       ``(A) Preparation of written notice.--A group health plan, 
     or a health insurance issuer offering health insurance 
     coverage in connection with a group health plan, shall post 
     or provide, in writing and in a clear and conspicuous manner, 
     notice of the plan or issuer's confidentiality practices, 
     that shall include--
       ``(i) a description of an individual's rights with respect 
     to predictive genetic information;
       ``(ii) the procedures established by the plan or issuer for 
     the exercise of the individual's rights; and
       ``(iii) the right to obtain a copy of the notice of the 
     confidentiality practices required under this subsection.
       ``(B) Model notice.--The Secretary, in consultation with 
     the National Committee on Vital and Health Statistics and the 
     National Association of Insurance Commissioners, and after 
     notice and opportunity for public comment, shall develop and 
     disseminate model notices of confidentiality practices. Use 
     of the model notice shall serve as a defense against claims 
     of receiving inappropriate notice.
       ``(2) Establishment of safeguards.--A group health plan, or 
     a health insurance issuer offering health insurance coverage 
     in connection with a group health plan, shall establish and 
     maintain appropriate administrative, technical, and physical 
     safeguards to protect the confidentiality, security, 
     accuracy, and integrity of predictive genetic information 
     created, received, obtained, maintained, used, transmitted, 
     or disposed of by such plan or issuer.''.
       (c) Definitions.--Section 733(d) of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1191b(d)) is amended 
     by adding at the end the following:
       ``(5) Family member.--The term `family member' means with 
     respect to an individual--
       ``(A) the spouse of the individual;
       ``(B) a dependent child of the individual, including a 
     child who is born to or placed for adoption with the 
     individual; and
       ``(C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       ``(6) Genetic information.--The term `genetic information' 
     means information about genes, gene products, or inherited 
     characteristics that may derive from an individual or a 
     family member (including information about a request for or 
     receipt of genetic services).
       ``(7) Genetic services.--The term `genetic services' means 
     health services provided to obtain, assess, or interpret 
     genetic information for diagnostic and therapeutic purposes, 
     and for genetic education and counseling.
       ``(8) Predictive genetic information.--
       ``(A) In general.--The term `predictive genetic 
     information' means, in the absence of symptoms, clinical 
     signs, or a diagnosis of the condition related to such 
     information--
       ``(i) information about an individual's genetic tests;
       ``(ii) information about genetic tests of family members of 
     the individual; or
       ``(iii) information about the occurrence of a disease or 
     disorder in family members.
       ``(B) Exceptions.--The term `predictive genetic 
     information' shall not include--
       ``(i) information about the sex or age of the individual;
       ``(ii) information derived from physical tests, such as the 
     chemical, blood, or urine

[[Page 13049]]

     analyses of the individual including cholesterol tests; and
       ``(iii) information about physical exams of the individual.
       ``(9) Genetic test.--The term `genetic test' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites, including analysis of genotypes, 
     mutations, phenotypes, or karyotypes, for the purpose of 
     predicting risk of disease in asymptomatic or undiagnosed 
     individuals. Such term does not include physical tests, such 
     as the chemical, blood, or urine analyses of the individual 
     including cholesterol tests, and physical exams of the 
     individual, in order to detect symptoms, clinical signs, or a 
     diagnosis of disease.''.
       (d) Effective Date.--Except as provided in this section, 
     this section and the amendments made by this section shall 
     apply with respect to group health plans for plan years 
     beginning 1 year after the date of the enactment of this Act.

     SEC. 403. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

       (a) Amendments Relating to the Group Market.--
       (1) Prohibition of health discrimination on the basis of 
     genetic information in the group market.--
       (A) No enrollment restriction for genetic services.--
     Section 2702(a)(1)(F) of the Public Health Service Act (42 
     U.S.C. 300gg-1(a)(1)(F)) is amended by inserting before the 
     period the following: ``(including information about a 
     request for or receipt of genetic services)''.
       (B) No discrimination in premiums based on predictive 
     genetic information.--Subpart 2 of part A of title XXVII of 
     the Public Health Service Act (42 U.S.C. 300gg-4 et seq.), as 
     amended by section 301(d), is amended by adding at the end 
     the following new section:

     ``SEC. 2708. PROHIBITING PREMIUM DISCRIMINATION AGAINST 
                   GROUPS ON THE BASIS OF PREDICTIVE GENETIC 
                   INFORMATION IN THE GROUP MARKET.

       ``A group health plan, or a health insurance issuer 
     offering group health insurance coverage in connection with a 
     group health plan shall not adjust premium or contribution 
     amounts for a group on the basis of predictive genetic 
     information concerning any individual (including a dependent) 
     or family member of the individual (including information 
     about a request for or receipt of genetic services).''.
       (C) Conforming amendment.--Section 2702(b) of the Public 
     Health Service Act (42 U.S.C. 300gg-1(b)) is amended by 
     adding at the end the following:
       ``(3) Reference to related provision.--For a provision 
     prohibiting the adjustment of premium or contribution amounts 
     for a group under a group health plan on the basis of 
     predictive genetic information (including information about a 
     request for or receipt of genetic services), see section 
     2708.''.
       (D) Limitation on collection and disclosure of predictive 
     genetic information.--Section 2702 of the Public Health 
     Service Act (42 U.S.C. 300gg-1) is amended by adding at the 
     end the following:
       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     group health plan, or a health insurance issuer offering 
     health insurance coverage in connection with a group health 
     plan, shall not request or require predictive genetic 
     information concerning any individual (including a dependent) 
     or a family member of the individual (including information 
     about a request for or receipt of genetic services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) In general.--Notwithstanding paragraph (1), a group 
     health plan, or a health insurance issuer offering health 
     insurance coverage in connection with a group health plan, 
     that provides health care items and services to an individual 
     or dependent may request (but may not require) that such 
     individual or dependent disclose, or authorize the collection 
     or disclosure of, predictive genetic information for purposes 
     of diagnosis, treatment, or payment relating to the provision 
     of health care items and services to such individual or 
     dependent.
       ``(B) Notice of confidentiality practices and description 
     of safeguards.--As a part of a request under subparagraph 
     (A), the group health plan, or a health insurance issuer 
     offering health insurance coverage in connection with a group 
     health plan, shall provide to the individual or dependent a 
     description of the procedures in place to safeguard the 
     confidentiality, as described in subsection (d), of such 
     predictive genetic information.
       ``(d) Confidentiality with Respect to Predictive Genetic 
     Information.--
       ``(1) Notice of confidentiality practices.--
       ``(A) Preparation of written notice.--A group health plan, 
     or a health insurance issuer offering health insurance 
     coverage in connection with a group health plan, shall post 
     or provide, in writing and in a clear and conspicuous manner, 
     notice of the plan or issuer's confidentiality practices, 
     that shall include--
       ``(i) a description of an individual's rights with respect 
     to predictive genetic information;
       ``(ii) the procedures established by the plan or issuer for 
     the exercise of the individual's rights; and
       ``(iii) the right to obtain a copy of the notice of the 
     confidentiality practices required under this subsection.
       ``(B) Model notice.--The Secretary, in consultation with 
     the National Committee on Vital and Health Statistics and the 
     National Association of Insurance Commissioners, and after 
     notice and opportunity for public comment, shall develop and 
     disseminate model notices of confidentiality practices. Use 
     of the model notice shall serve as a defense against claims 
     of receiving inappropriate notice.
       ``(2) Establishment of safeguards.--A group health plan, or 
     a health insurance issuer offering health insurance coverage 
     in connection with a group health plan, shall establish and 
     maintain appropriate administrative, technical, and physical 
     safeguards to protect the confidentiality, security, 
     accuracy, and integrity of predictive genetic information 
     created, received, obtained, maintained, used, transmitted, 
     or disposed of by such plan or issuer.''.
       (2) Definitions.--Section 2791(d) of the Public Health 
     Service Act (42 U.S.C. 300gg-91(d)) is amended by adding at 
     the end the following:
       ``(15) Family member.--The term `family member' means, with 
     respect to an individual--
       ``(A) the spouse of the individual;
       ``(B) a dependent child of the individual, including a 
     child who is born to or placed for adoption with the 
     individual; and
       ``(C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       ``(16) Genetic information.--The term `genetic information' 
     means information about genes, gene products, or inherited 
     characteristics that may derive from an individual or a 
     family member (including information about a request for or 
     receipt of genetic services).
       ``(17) Genetic services.--The term `genetic services' means 
     health services provided to obtain, assess, or interpret 
     genetic information for diagnostic and therapeutic purposes, 
     and for genetic education and counseling.
       ``(18) Predictive genetic information.--
       ``(A) In general.--The term `predictive genetic 
     information' means, in the absence of symptoms, clinical 
     signs, or a diagnosis of the condition related to such 
     information--
       ``(i) information about an individual's genetic tests;
       ``(ii) information about genetic tests of family members of 
     the individual; or
       ``(iii) information about the occurrence of a disease or 
     disorder in family members.
       ``(B) Exceptions.--The term `predictive genetic 
     information' shall not include--
       ``(i) information about the sex or age of the individual;
       ``(ii) information derived from physical tests, such as the 
     chemical, blood, or urine analyses of the individual 
     including cholesterol tests; and
       ``(iii) information about physical exams of the individual.
       ``(19) Genetic test.--The term `genetic test' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites, including analysis of genotypes, 
     mutations, phenotypes, or karyotypes, for the purpose of 
     predicting risk of disease in asymptomatic or undiagnosed 
     individuals. Such term does not include physical tests, such 
     as the chemical, blood, or urine analyses of the individual 
     including cholesterol tests, and physical exams of the 
     individual, in order to detect symptoms, clinical signs, or a 
     diagnosis of disease.''.
       (e) Amendments to PHSA Relating to the Individual Market.--
     The first subpart 3 of part B of title XXVII of the Public 
     Health Service Act (42 U.S.C. 300gg-51 et seq.) (relating to 
     other requirements) (42 U.S.C. 300gg-51 et seq.), as amended 
     by section 301(e), is further amended by adding at the end 
     the following:

     ``SEC. 2754. PROHIBITION OF HEALTH DISCRIMINATION ON THE 
                   BASIS OF PREDICTIVE GENETIC INFORMATION.

       ``(a) Prohibition on Predictive Genetic Information as a 
     Condition of Eligibility.--A health insurance issuer offering 
     health insurance coverage in the individual market may not 
     use predictive genetic information as a condition of 
     eligibility of an individual to enroll in individual health 
     insurance coverage (including information about a request for 
     or receipt of genetic services).
       ``(b) Prohibition on Predictive Genetic Information in 
     Setting Premium Rates.--A health insurance issuer offering 
     health insurance coverage in the individual market shall not 
     adjust premium rates for individuals on the basis of 
     predictive genetic information concerning such an individual 
     (including a dependent) or a family member of the individual 
     (including information about a request for or receipt of 
     genetic services).
       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     health insurance issuer offering health insurance coverage in 
     the individual market shall not request or require predictive 
     genetic information concerning any individual (including

[[Page 13050]]

     a dependent) or a family member of the individual (including 
     information about a request for or receipt of genetic 
     services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) in general.--Notwithstanding paragraph (1), a health 
     insurance issuer offering health insurance coverage in the 
     individual market that provides health care items and 
     services to an individual or dependent may request (but may 
     not require) that such individual or dependent disclose, or 
     authorize the collection or disclosure of, predictive genetic 
     information for purposes of diagnosis, treatment, or payment 
     relating to the provision of health care items and services 
     to such individual or dependent.
       ``(B) Notice of confidentiality practices and description 
     of safeguards.--As a part of a request under subparagraph 
     (A), the health insurance issuer offering health insurance 
     coverage in the individual market shall provide to the 
     individual or dependent a description of the procedures in 
     place to safeguard the confidentiality, as described in 
     subsection (d), of such predictive genetic information.
       ``(d) Confidentiality with Respect to Predictive Genetic 
     Information.--
       ``(1) Notice of confidentiality practices.--
       ``(A) Preparation of written notice.--A health insurance 
     issuer offering health insurance coverage in the individual 
     market shall post or provide, in writing and in a clear and 
     conspicuous manner, notice of the issuer's confidentiality 
     practices, that shall include--
       ``(i) a description of an individual's rights with respect 
     to predictive genetic information;
       ``(ii) the procedures established by the issuer for the 
     exercise of the individual's rights; and
       ``(iii) the right to obtain a copy of the notice of the 
     confidentiality practices required under this subsection.
       ``(B) Model notice.--The Secretary, in consultation with 
     the National Committee on Vital and Health Statistics and the 
     National Association of Insurance Commissioners, and after 
     notice and opportunity for public comment, shall develop and 
     disseminate model notices of confidentiality practices. Use 
     of the model notice shall serve as a defense against claims 
     of receiving inappropriate notice.
       ``(2) Establishment of safeguards.--A health insurance 
     issuer offering health insurance coverage in the individual 
     market shall establish and maintain appropriate 
     administrative, technical, and physical safeguards to protect 
     the confidentiality, security, accuracy, and integrity of 
     predictive genetic information created, received, obtained, 
     maintained, used, transmitted, or disposed of by such 
     issuer.''.
       (c) Effective Date.--The amendments made by this section 
     shall apply with respect to--
       (1) group health plans, and health insurance coverage 
     offered in connection with group health plans, for plan years 
     beginning after 1 year after the date of enactment of this 
     Act; and
       (2) health insurance coverage offered, sold, issued, 
     renewed, in effect, or operated in the individual market 
     after 1 year after the date of enactment of this Act.

     SEC. 404. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.

       (a) Prohibition of Health Discrimination on the Basis of 
     Genetic Information or Genetic Services.--
       (1) No enrollment restriction for genetic services.--
     Section 9802(a)(1)(F) of the Internal Revenue Code of 1986 is 
     amended by inserting before the period the following: 
     ``(including information about a request for or receipt of 
     genetic services)''.
       (2) No discrimination in group premiums based on predictive 
     genetic information.--
       (A) In general.--Subchapter B of chapter 100 of the 
     Internal Revenue Code of 1986, as amended by section 301(f), 
     is further amended by adding at the end the following:

     ``SEC. 9815. PROHIBITING PREMIUM DISCRIMINATION AGAINST 
                   GROUPS ON THE BASIS OF PREDICTIVE GENETIC 
                   INFORMATION.

       ``A group health plan shall not adjust premium or 
     contribution amounts for a group on the basis of predictive 
     genetic information concerning any individual (including a 
     dependent) or a family member of the individual (including 
     information about a request for or receipt of genetic 
     services).''.
       (B) Conforming amendment.--Section 9802(b) of the Internal 
     Revenue Code of 1986 is amended by adding at the end the 
     following:
       ``(3) Reference to related provision.--For a provision 
     prohibiting the adjustment of premium or contribution amounts 
     for a group under a group health plan on the basis of 
     predictive genetic information (including information about a 
     request for or the receipt of genetic services), see section 
     9815.''.
       (C) Amendment to table of sections.--The table of sections 
     for subchapter B of chapter 100 of the Internal Revenue Code 
     of 1986, as amended by section 301(f), is further amended by 
     adding at the end the following:

``Sec. 9815. Prohibiting premium discrimination against groups on the 
              basis of predictive genetic information.''.

       (b) Limitation on Collection of Predictive Genetic 
     Information.--Section 9802 of the Internal Revenue Code of 
     1986 is amended by adding at the end the following:
       ``(d) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     group health plan shall not request or require predictive 
     genetic information concerning any individual (including a 
     dependent) or a family member of the individual (including 
     information about a request for or receipt of genetic 
     services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) In general.--Notwithstanding paragraph (1), a group 
     health plan that provides health care items and services to 
     an individual or dependent may request (but may not require) 
     that such individual or dependent disclose, or authorize the 
     collection or disclosure of, predictive genetic information 
     for purposes of diagnosis, treatment, or payment relating to 
     the provision of health care items and services to such 
     individual or dependent.
       ``(B) Notice of confidentiality practices; description of 
     safeguards.--As a part of a request under subparagraph (A), 
     the group health plan shall provide to the individual or 
     dependent a description of the procedures in place to 
     safeguard the confidentiality, as described in subsection 
     (e), of such predictive genetic information.
       ``(e) Confidentiality with Respect to Predictive Genetic 
     Information.--
       ``(1) Notice of confidentiality practices.--
       ``(A) Preparation of written notice.--A group health plan 
     shall post or provide, in writing and in a clear and 
     conspicuous manner, notice of the plan's confidentiality 
     practices, that shall include--
       ``(i) a description of an individual's rights with respect 
     to predictive genetic information;
       ``(ii) the procedures established by the plan for the 
     exercise of the individual's rights; and
       ``(iii) the right to obtain a copy of the notice of the 
     confidentiality practices required under this subsection.
       ``(B) Model notice.--The Secretary, in consultation with 
     the National Committee on Vital and Health Statistics and the 
     National Association of Insurance Commissioners, and after 
     notice and opportunity for public comment, shall develop and 
     disseminate model notices of confidentiality practices. Use 
     of the model notice shall serve as a defense against claims 
     of receiving inappropriate notice.
       ``(2) Establishment of safeguards.--A group health plan 
     shall establish and maintain appropriate administrative, 
     technical, and physical safeguards to protect the 
     confidentiality, security, accuracy, and integrity of 
     predictive genetic information created, received, obtained, 
     maintained, used, transmitted, or disposed of by such 
     plan.''.
       (c) Definitions.--Section 9832(d) of the Internal Revenue 
     Code of 1986 is amended by adding at the end the following:
       ``(6) Family member.--The term `family member' means, with 
     respect to an individual--
       ``(A) the spouse of the individual;
       ``(B) a dependent child of the individual, including a 
     child who is born to or placed for adoption with the 
     individual; and
       ``(C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       ``(7) Genetic information.--The term `genetic information' 
     means information about genes, gene products, or inherited 
     characteristics that may derive from an individual or a 
     family member (including information about a request for or 
     receipt of genetic services).
       ``(8) Genetic services.--The term `genetic services' means 
     health services provided to obtain, assess, or interpret 
     genetic information for diagnostic and therapeutic purposes, 
     and for genetic education and counseling.
       ``(9) Predictive genetic information.--
       ``(A) In general.--The term `predictive genetic 
     information' means, in the absence of symptoms, clinical 
     signs, or a diagnosis of the condition related to such 
     information--
       ``(i) information about an individual's genetic tests;
       ``(ii) information about genetic tests of family members of 
     the individual; or
       ``(iii) information about the occurrence of a disease or 
     disorder in family members.
       ``(B) Exceptions.--The term `predictive genetic 
     information' shall not include--
       ``(i) information about the sex or age of the individual;
       ``(ii) information derived from physical tests, such as the 
     chemical, blood, or urine analyses of the individual 
     including cholesterol tests; and
       ``(iii) information about physical exams of the individual.
       ``(10) Genetic test.--The term `genetic test' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites, including analysis of genotypes, 
     mutations, phenotypes, or karyotypes, for the purpose of 
     predicting risk of disease in asymptomatic or undiagnosed 
     individuals. Such term does not include physical tests,

[[Page 13051]]

     such as the chemical, blood, or urine analyses of the 
     individual including cholesterol tests, and physical exams of 
     the individual, in order to detect symptoms, clinical signs, 
     or a diagnosis of disease.''.
       (d) Effective Date.--Except as provided in this section, 
     this section and the amendments made by this section shall 
     apply with respect to group health plans for plan years 
     beginning after 1 year after the date of the enactment of 
     this Act.

              TITLE V--PATIENT SAFETY AND ERRORS REDUCTION

     SEC. 501. SHORT TITLE.

       This title may be cited as the ``Patient Safety and Errors 
     Reduction Act''.

     SEC. 502. PURPOSES.

       It is the purpose of this title to--
       (1) promote the identification, evaluation, and reporting 
     of medical errors;
       (2) raise standards and expectations for improvements in 
     patient safety;
       (3) reduce deaths, serious injuries, and other medical 
     errors through the implementation of safe practices at the 
     delivery level;
       (4) develop error reduction systems with legal protections 
     to support the collection of information under such systems;
       (5) extend existing confidentiality and peer review 
     protections to the reports relating to medical errors that 
     are reported under such systems that are developed for safety 
     and quality improvement purposes; and
       (6) provide for the establishment of systems of information 
     collection, analysis, and dissemination to enhance the 
     knowledge base concerning patient safety.

     SEC. 503. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.

       Title IX of the Public Health Service Act (42 U.S.C. 299 et 
     seq.) is amended--
       (1) by redesignating part C as part D;
       (2) by redesignating sections 921 through 928, as sections 
     931 through 938, respectively;
       (3) in section 938(1) (as so redesignated), by striking 
     ``921'' and inserting ``931''; and
       (4) by inserting after part B the following:

                ``PART C--REDUCING ERRORS IN HEALTH CARE

     ``SEC. 921. DEFINITIONS.

       ``In this part:
       ``(1) Adverse event.--The term `adverse event' means, with 
     respect to the patient of a provider of services, an untoward 
     incident, therapeutic misadventure, or iatrogenic injury 
     directly associated with the provision of health care items 
     and services by a health care provider or provider of 
     services.
       ``(2) Center.--The term `Center' means the Center for 
     Quality Improvement and Patient Safety established under 
     section 922(b).
       ``(3) Close call.--The term `close call' means, with 
     respect to the patient of a provider of services, any event 
     or situation that--
       ``(A) but for chance or a timely intervention, could have 
     resulted in an accident, injury, or illness; and
       ``(B) is directly associated with the provision of health 
     care items and services by a provider of services.
       ``(4) Expert organization.--The term `expert organization' 
     means a third party acting on behalf of, or in conjunction 
     with, a provider of services to collect information about, or 
     evaluate, a medical event.
       ``(5) Health care oversight agency.--The term `health care 
     oversight agency' means an agency, entity, or person, 
     including the employees and agents thereof, that performs or 
     oversees the performance of any activities necessary to 
     ensure the safety of the health care system.
       ``(6) Health care provider.--The term `health care 
     provider' means--
       ``(A) any provider of services (as defined in section 
     1861(u) of the Social Security Act); and
       ``(B) any person furnishing any medical or other health 
     care services as defined in section 1861(s)(1) and (2) of 
     such Act through, or under the authority of, a provider of 
     services described in subparagraph (A).
       ``(7) Provider of services.--The term `provider of 
     services' means a hospital, skilled nursing facility, 
     comprehensive outpatient rehabilitation facility, home health 
     agency, renal dialysis facility, ambulatory surgical center, 
     or hospice program, and any other entity specified in 
     regulations promulgated by the Secretary after public notice 
     and comment.
       ``(8) Public health authority.--The term `public health 
     authority' means an agency or authority of the United States, 
     a State, a territory, a political subdivision of a State or 
     territory, and an Indian tribe that is responsible for public 
     health matters as part of its official mandate.
       ``(9) Medical event.--The term `medical event' means, with 
     respect to the patient of a provider of services, any 
     sentinel event, adverse event, or close call.
       ``(10) Medical event analysis entity.--The term `medical 
     event analysis entity' means an entity certified under 
     section 923(a).
       ``(11) Root cause analysis.--
       ``(A) In general.--The term `root cause analysis' means a 
     process for identifying the basic or contributing causal 
     factors that underlie variation in performance associated 
     with medical events that--
       ``(i) has the characteristics described in subparagraph 
     (B);
       ``(ii) includes participation by the leadership of the 
     provider of services and individuals most closely involved in 
     the processes and systems under review;
       ``(iii) is internally consistent; and
       ``(iv) includes the consideration of relevant literature.
       ``(B) Characteristics.--The characteristics described in 
     this subparagraph include the following:
       ``(i) The analysis is interdisciplinary in nature and 
     involves those individuals who are responsible for 
     administering the reporting systems.
       ``(ii) The analysis focuses primarily on systems and 
     processes rather than individual performance.
       ``(iii) The analysis involves a thorough review of all 
     aspects of the process and all contributing factors involved.
       ``(iv) The analysis identifies changes that could be made 
     in systems and processes, through either redesign or 
     development of new processes or systems, that would improve 
     performance and reduce the risk of medical events.
       ``(12) Sentinel event.--The term `sentinel event' means, 
     with respect to the patient of a provider of services, an 
     unexpected occurrence that--
       ``(A) involves death or serious physical or psychological 
     injury (including loss of a limb); and
       ``(B) is directly associated with the provision of health 
     care items and services by a health care provider or provider 
     of services.

     ``SEC. 922. RESEARCH TO IMPROVE THE QUALITY AND SAFETY OF 
                   PATIENT CARE.

       ``(a) In General.--To improve the quality and safety of 
     patient care, the Director shall--
       ``(1) conduct and support research, evaluations and 
     training, support demonstration projects, provide technical 
     assistance, and develop and support partnerships that will 
     identify and determine the causes of medical errors and other 
     threats to the quality and safety of patient care;
       ``(2) identify and evaluate interventions and strategies 
     for preventing or reducing medical errors and threats to the 
     quality and safety of patient care;
       ``(3) identify, in collaboration with experts from the 
     public and private sector, reporting parameters to provide 
     consistency throughout the errors reporting system;
       ``(4) identify approaches for the clinical management of 
     complications from medical errors; and
       ``(5) establish mechanisms for the rapid dissemination of 
     interventions and strategies identified under this section 
     for which there is scientific evidence of effectiveness.
       ``(b) Center for Quality Improvement and Patient Safety.--
       ``(1) Establishment.--The Director shall establish a center 
     to be known as the Center for Quality Improvement and Patient 
     Safety to assist the Director in carrying out the 
     requirements of subsection (a).
       ``(2) Mission.--The Center shall--
       ``(A) provide national leadership for research and other 
     initiatives to improve the quality and safety of patient 
     care;
       ``(B) build public-private sector partnerships to improve 
     the quality and safety of patient care; and
       ``(C) serve as a national resource for research and 
     learning from medical errors.
       ``(3) Duties.--
       ``(A) In general.--In carrying out this section, the 
     Director, acting through the Center, shall consult and build 
     partnerships, as appropriate, with all segments of the health 
     care industry, including health care practitioners and 
     patients, those who manage health care facilities, systems 
     and plans, peer review organizations, health care purchasers 
     and policymakers, and other users of health care research.
       ``(B) Required duties.--In addition to the broad 
     responsibilities that the Director may assign to the Center 
     for research and related activities that are designed to 
     improve the quality of health care, the Director shall ensure 
     that the Center--
       ``(i) builds scientific knowledge and understanding of the 
     causes of medical errors in all health care settings and 
     identifies or develops and validates effective interventions 
     and strategies to reduce errors and improve the safety and 
     quality of patient care;
       ``(ii) promotes public and private sector research on 
     patient safety by--

       ``(I) developing a national patient safety research agenda;
       ``(II) identifying promising opportunities for preventing 
     or reducing medical errors; and
       ``(III) tracking the progress made in addressing the 
     highest priority research questions with respect to patient 
     safety;

       ``(iii) facilitates the development of voluntary national 
     patient safety goals by convening all segments of the health 
     care industry and tracks the progress made in meeting those 
     goals;
       ``(iv) analyzes national patient safety data for inclusion 
     in the annual report on the quality of health care required 
     under section 913(b)(2);
       ``(v) strengthens the ability of the United States to learn 
     from medical errors by--

       ``(I) developing the necessary tools and advancing the 
     scientific techniques for analysis of errors;
       ``(II) providing technical assistance as appropriate to 
     reporting systems; and

[[Page 13052]]

       ``(III) entering into contracts to receive and analyze 
     aggregate data from public and private sector reporting 
     systems;

       ``(vi) supports dissemination and communication activities 
     to improve patient safety, including the development of tools 
     and methods for educating consumers about patient safety; and
       ``(vii) undertakes related activities that the Director 
     determines are necessary to enable the Center to fulfill its 
     mission.
       ``(C) Limitation.--Aggregate data gathered for the purposes 
     described in this section shall not include specific patient, 
     health care provider, or provider of service identifiers.
       ``(c) Learning From Medical Errors.--
       ``(1) In general.--To enhance the ability of the health 
     care community in the United States to learn from medical 
     events, the Director shall--
       ``(A) carry out activities to increase scientific knowledge 
     and understanding regarding medical error reporting systems;
       ``(B) carry out activities to advance the scientific 
     knowledge regarding the tools and techniques for analyzing 
     medical events and determining their root causes;
       ``(C) carry out activities in partnership with experts in 
     the field to increase the capacity of the health care 
     community in the United States to analyze patient safety 
     data;
       ``(D) develop a confidential national safety database of 
     medical event reports;
       ``(E) conduct and support research, using the database 
     developed under subparagraph (D), into the causes and 
     potential interventions to decrease the incidence of medical 
     errors and close calls; and
       ``(F) ensure that information contained in the national 
     database developed under subparagraph (D) does not include 
     specific patient, health care provider, or provider of 
     service identifiers.
       ``(2) National patient safety database.--The Director 
     shall, in accordance with paragraph (1)(D), establish a 
     confidential national safety database (to be known as the 
     National Patient Safety Database) of reports of medical 
     events that can be used only for research to improve the 
     quality and safety of patient care. In developing and 
     managing the National Patient Safety Database, the Director 
     shall--
       ``(A) ensure that the database is only used for its 
     intended purpose;
       ``(B) ensure that the database is only used by the Agency, 
     medical event analysis entities, and other qualified entities 
     or individuals as determined appropriate by the Director and 
     in accordance with paragraph (3) or other criteria applied by 
     the Director;
       ``(C) ensure that the database is as comprehensive as 
     possible by aggregating data from Federal, State, and private 
     sector patient safety reporting systems;
       ``(D) conduct and support research on the most common 
     medical errors and close calls, their causes, and potential 
     interventions to reduce medical errors and improve the 
     quality and safety of patient care;
       ``(E) disseminate findings made by the Director, based on 
     the data in the database, to clinicians, individuals who 
     manage health care facilities, systems, and plans, patients, 
     and other individuals who can act appropriately to improve 
     patient safety; and
       ``(F) develop a rapid response capacity to provide alerts 
     when specific health care practices pose an imminent threat 
     to patients or health care practitioners, or other providers 
     of health care items or services.
       ``(3) Confidentiality and peer review protections.--
     Notwithstanding any other provision of law any information 
     (including any data, reports, records, memoranda, analyses, 
     statements, and other communications) developed by or on 
     behalf of a health care provider or provider of services with 
     respect to a medical event, that is contained in the National 
     Patient Safety Database shall be confidential in accordance 
     with section 925.
       ``(4) Patient safety reporting systems.--The Director shall 
     identify public and private sector patient safety reporting 
     systems and build scientific knowledge and understanding 
     regarding the most effective--
       ``(A) components of patient safety reporting systems;
       ``(B) incentives intended to increase the rate of error 
     reporting;
       ``(C) approaches for undertaking root cause analyses;
       ``(D) ways to provide feedback to those filing error 
     reports;
       ``(E) techniques and tools for collecting, integrating, and 
     analyzing patient safety data; and
       ``(F) ways to provide meaningful information to patients, 
     consumers, and purchasers that will enhance their 
     understanding of patient safety issues.
       ``(5) Training.--The Director shall support training 
     initiatives to build the capacity of the health care 
     community in the United States to analyze patient safety data 
     and to act on that data to improve patient safety.
       ``(d) Evaluation.--The Director shall recommend strategies 
     for measuring and evaluating the national progress made in 
     implementing safe practices identified by the Center through 
     the research and analysis required under subsection (b) and 
     through the voluntary reporting system established under 
     subsection (c).
       ``(e) Implementation.--In implementing strategies to carry 
     out the functions described in subsections (b), (c), and (d), 
     the Director may contract with public or private entities on 
     a national or local level with appropriate expertise.

     ``SEC. 923. MEDICAL EVENT ANALYSIS ENTITIES.

       ``(a) In General.--The Director, based on information 
     collected under section 922(c), shall provide for the 
     certification of entities to collect and analyze information 
     on medical errors, and to collaborate with health care 
     providers or providers of services in collecting information 
     about, or evaluating, certain medical events.
       ``(b) Compatibility of Collected Data.--To ensure that data 
     reported to the National Patient Safety Database under 
     section 922(c)(2) concerning medical errors and close calls 
     are comparable and useful on an analytic basis, the Director 
     shall require that the entities described in subsection (c) 
     follow the recommendations regarding a common set of core 
     measures for reporting that are developed by the National 
     Forum for Health Care Quality Measurement and Reporting, or 
     other voluntary private standard-setting organization that is 
     designated by the Director taking into account existing 
     measurement systems and in collaboration with experts from 
     the public and private sector.
       ``(c) Duties of Certified Entities.--
       ``(1) In general.--An entity that is certified under 
     subsection (a) shall collect and analyze information, 
     consistent with the requirement of subsection (b), provided 
     to the entity under section 924(a)(4) to improve patient 
     safety.
       ``(2) Information to be reported to the entity.--A medical 
     event analysis entity shall, on a periodic basis and in a 
     format that is specified by the Director, submit to the 
     Director a report that contains--
       ``(A) a description of the medical events that were 
     reported to the entity during the period covered under the 
     report;
       ``(B) a description of any corrective action taken by 
     providers of services with respect to such medical events or 
     any other measures that are necessary to prevent similar 
     events from occurring in the future; and
       ``(C) a description of the systemic changes that entities 
     have identified, through an analysis of the medical events 
     included in the report, as being needed to improve patient 
     safety.
       ``(3) Collaboration.--A medical event analysis entity that 
     is collaborating with a health care provider or provider of 
     services to address close calls and adverse events may, at 
     the request of the health care provider or provider of 
     services--
       ``(A) provide expertise in the development of root cause 
     analyses and corrective action plan relating to such close 
     calls and adverse events; or
       ``(B) collaborate with such provider of services to 
     identify on-going risk reduction activities that may enhance 
     patient safety.
       ``(d) Confidentiality and Peer Review Protections.--
     Notwithstanding any other provision of law, any information 
     (including any data, reports, records, memoranda, analyses, 
     statements, and other communications) collected by a medical 
     event analysis entity or developed by or on behalf of such an 
     entity under this part shall be confidential in accordance 
     with section 925.
       ``(e) Termination and Renewal.--
       ``(1) In general.--The certification of an entity under 
     this section shall terminate on the date that is 3 years 
     after the date on which such certification was provided. Such 
     certification may be renewed at the discretion of the 
     Director.
       ``(2) Noncompliance.--The Director may terminate the 
     certification of a medical event analysis entity if the 
     Director determines that such entity has failed to comply 
     with this section.
       ``(f) Implementation.--In implementing strategies to carry 
     out the functions described in subsection (c), the Director 
     may contract with public or private entities on a national or 
     local level with appropriate expertise.

     ``SEC. 924. PROVIDER OF SERVICES SYSTEMS FOR REPORTING 
                   MEDICAL EVENTS.

       ``(a) Internal Medical Event Reporting Systems.--Each 
     provider of services that elects to participate in a medical 
     error reporting system under this part shall--
       ``(1) establish a system for--
       ``(A) identifying, collecting information about, and 
     evaluating medical events that occur with respect to a 
     patient in the care of the provider of services or a 
     practitioner employed by the provider of services, that may 
     include--
       ``(i) the provision of a medically coherent description of 
     each event so identified;
       ``(ii) the provision of a clear and thorough accounting of 
     the results of the investigation of such event under the 
     system; and
       ``(iii) a description of all corrective measures taken in 
     response to the event; and
       ``(B) determining appropriate follow-up actions to be taken 
     with respect to such events;
       ``(2) establish policies and procedures with respect to 
     when and to whom such events are to be reported;
       ``(3) take appropriate follow-up action with respect to 
     such events; and
       ``(4) submit to the appropriate medical event analysis 
     entity information that contains descriptions of the medical 
     events identified under paragraph (1)(A).

[[Page 13053]]

       ``(b) Promoting Identification, Evaluation, and Reporting 
     of Certain Medical Events.--
       ``(1) In general.--Notwithstanding any other provision of 
     law any information (including any data, reports, records, 
     memoranda, analyses, statements, and other communications) 
     developed by or on behalf of a provider of services with 
     respect to a medical event pursuant to a system established 
     under subsection (a) shall be privileged in accordance with 
     section 925.
       ``(2) Rules of construction.--Nothing in this subsection 
     shall be construed as prohibiting--
       ``(A) disclosure of a patient's medical record to the 
     patient;
       ``(B) a provider of services from complying with the 
     requirements of a health care oversight agency or public 
     health authority; or
       ``(C) such an agency or authority from disclosing 
     information transferred by a provider of services to the 
     public in a form that does not identify or permit the 
     identification of the health care provider or provider of 
     services or patient.

     ``SEC. 925. CONFIDENTIALITY.

       ``(a) Confidentiality and Peer Review Protections.--
     Notwithstanding any other provision of law--
       ``(1) any information (including any data, reports, 
     records, memoranda, analyses, statements, and other 
     communications) developed by or on behalf of a health care 
     provider or provider of services with respect to a medical 
     event, that is contained in the National Patient Safety 
     Database, collected by a medical event analysis entity, or 
     developed by or on behalf of such an entity, or collected by 
     a health care provider or provider or services for use under 
     systems that are developed for safety and quality improvement 
     purposes under this part--
       ``(A) shall be privileged, strictly confidential, and may 
     not be disclosed by any other person to which such 
     information is transferred without the authorization of the 
     health care provider or provider of services; and
       ``(B) shall--
       ``(i) be protected from disclosure by civil, criminal, or 
     administrative subpoena;
       ``(ii) not be subject to discovery or otherwise 
     discoverable in connection with a civil, criminal, or 
     administrative proceeding;
       ``(iii) not be subject to disclosure pursuant to section 
     552 of title 5, United States Code (the Freedom of 
     Information Act) and any other similar Federal or State 
     statute or regulation; and
       ``(iv) not be admissible as evidence in any civil, 
     criminal, or administrative proceeding;
     without regard to whether such information is held by the 
     provider or by another person to which such information was 
     transferred;
       ``(2) the transfer of any such information by a provider of 
     services to a health care oversight agency, an expert 
     organization, a medical event analysis entity, or a public 
     health authority, shall not be treated as a waiver of any 
     privilege or protection established under paragraph (1) or 
     established under State law.
       ``(b) Penalty.--It shall be unlawful for any person to 
     disclose any information described in subsection (a) other 
     than for the purposes provided in such subsection. Any person 
     violating the provisions of this section shall, upon 
     conviction, be fined in accordance with title 18, United 
     States Code, and imprisoned for not more than 6 months, or 
     both.
       ``(c) Application of provisions.--The protections provided 
     under subsection (a) and the penalty provided for under 
     subsection (b) shall apply to any information (including any 
     data, reports, memoranda, analyses, statements, and other 
     communications) collected or developed pursuant to research, 
     including demonstration projects, with respect to medical 
     error reporting supported by the Director under this part.

     ``SEC. 926. AUTHORIZATION OF APPROPRIATIONS.

       ``There is authorized to be appropriated to carry out this 
     part, $50,000,000 for fiscal year 2001, and such sums as may 
     be necessary for subsequent fiscal years.''.

     SEC. 504. EFFECTIVE DATE.

       The amendments made by section 503 shall become effective 
     on the date of the enactment of this Act.
       This Act may be cited as the ``Departments of Labor, Health 
     and Human Services, and Education, and Related Agencies 
     Appropriations Act, 2001.''.
                                 ______
                                 

                       SCHUMER AMENDMENT NO. 3695

  (Ordered to lie on the table.)
  Mr. SCHUMER submitted an amendment intended to be proposed by him to 
the bill, H.R. 4577, supra; as follows:

       On page 27, line 24, before the period insert the 
     following: ``: Provided further, That in addition to amounts 
     made available under this heading for the National Program of 
     Cancer Registries, an additional $15,000,000 shall be made 
     available for such Program and special emphasis in carrying 
     out such Program shall be given to States with the highest 
     number of the leading causes of cancer mortality: Provided 
     further, That amounts made available under this Act for the 
     administrative and related expenses of the Centers for 
     Disease Control and Prevention shall be reduced by 
     $15,000,000''.
                                 ______
                                 

                      BINGAMAN AMENDMENT NO. 3696

  (Ordered to lie on the table.)
  Mr. BINGAMAN (for himself, Mr. Daschle, Mr. Johnson, Mr. McCain, Mr. 
Conrad, Mrs. Murray, Mr. Leahy, and Mrs. Boxer) submitted an amendment 
intended to be proposed by him to the bill, H.R. 4577, supra; as 
follows:

       At the end of title III, insert the following:

     SEC. __. CONSTRUCTION AND RENOVATION PROJECTS.

       Notwithstanding any other provision of this Act--
       (1) the amount made available under this title under the 
     heading ``Office of Postsecondary Education'' under the 
     heading ``higher education'' to carry out section 316 of the 
     Higher Education Act of 1965 is increased by $6,000,000, 
     which increase shall be used for construction and renovation 
     projects under such section; and
       (2) the amount made available under this title under the 
     heading ``Office of Postsecondary Education'' under the 
     heading ``higher education'' to carry out part B of title VII 
     of the Higher Education Act of 1965 is decreased by 
     $5,000,000.
                                 ______
                                 

                        HELMS AMENDMENT NO. 3697

  Mr. HELMS proposed an amendment to the bill, H.R. 4577, supra; as 
follows:

       At the appropriate place, insert the following:
       Sec. __. (a) None of the funds appropriated under this Act 
     to carry out section 330 or title X of the Public Health 
     Service Act (42 U.S.C. 254b, 300 et seq.), title V or XIX of 
     the Social Security Act (42 U.S.C. 701 et seq., 1396 et 
     seq.), or any other provision of law, shall be used for the 
     distribution or provision of postcoital emergency 
     contraception, or the provision of a prescription for 
     postcoital emergency contraception, to an unemancipated 
     minor, on the premises or in the facilities of any elementary 
     school or secondary school.
       (b) This section takes effect 1 day after the date of 
     enactment of this Act.
       (c) In this section:
       (1) The terms ``elementary school'' and ``secondary 
     school'' have the meanings given the terms in section 14101 
     of the Elementary and Secondary Education Act of 1965 (20 
     U.S.C. 8801).
       (2) The term ``unemancipated minor'' means an unmarried 
     individual who is 17 years of age or younger and is a 
     dependent, as defined in section 152(a) of the Internal 
     Revenue Code of 1986.
                                 ______
                                 

               WELLSTONE (AND JOHNSON) AMENDMENT NO. 3698

  Mr. WELLSTONE (for himself and Mr. Johnson) proposed an amendment to 
the bill, H.R. 4577, supra; as follows:

       On page 92, between lines 4 and 5, insert the following:
       Sec. __. (a) Limitation on Use of Funds for Certain 
     Agreements.--Except as provided in subsection (b), none of 
     the funds made available under this Act may be used by the 
     Secretary of Health and Human Services to enter into--
       (1) an agreement on the conveyance or licensing of a patent 
     for a drug, or on another exclusive right to a drug;
       (2) an agreement on the use of information derived from 
     animal tests or human clinical trials that are conducted by 
     the Department of Health and Human Services with respect to a 
     drug, including an agreement under which such information is 
     provided by the Department to another Federal agency on an 
     exclusive basis; or
       (3) a cooperative research and development agreement under 
     section 12 of the Stevenson-Wydler Technology Innovation Act 
     of 1980 (15 U.S.C. 3710a) pertaining to a drug, excluding 
     cooperative research and development agreements between the 
     Department of Health and Human Services and a college or 
     university.
       (b) Exceptions.--Subsection (a) shall not apply to an 
     agreement where--
       (1) the sale of the drug involved is subject to a price 
     agreement that is reasonable (as defined by the Secretary of 
     Health and Human Services); or
       (2) a reasonable price agreement with respect to the sale 
     of the drug involved is not required by the public interest 
     (as defined by such Secretary).
       (c) Rule of Construction.--Nothing in this section shall be 
     construed to apply to any agreement entered into by a college 
     or university and any entity other than the Secretary of 
     Health and Human Services or an entity within the Department 
     of Health and Human Services.
                                 ______
                                 

               HARKIN (AND WELLSTONE) AMENDMENT NO. 3699

  Mr. HARKIN (for himself and Mr. Wellstone) proposed an amendment to 
the bill, H.R. 4577, as follows:

       On page 60, line 16, strike ``$7,352,341,000'' and insert 
     ``$15,800,000,000.''
       On page 60, line 19, strike ``$4,624,000,000'' and insert 
     ``$13,071,659,000.''




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