“(B) DEFINITIONS.-In this subsection: "(i) EMERGENCY MEDICAL CONDITION.-The term 'emergency medical condition' means"(I) 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 a condition described in clause (i), (ii), or (iii) of section 1867(e)(1)(A) of the Social Security Act (42 U.S.C. 1395dd(e)(1)(A)); and "(II) a medical condition manifesting itself in a neonate by acute symptoms of sufficient severity (including severe pain) such that a prudent health care professional could reasonably expect the absence of immediate medical attention to result in a condition described in clause (i), (ii), or (iii) of section 1867(e)(1)(A) of the Social Security Act. "(ii) EMERGENCY SERVICES.-The 'emergency services' means term "(I) with respect to an emergency medical condition described in clause (i)(I), a medical screening examination (as required under section 1867 of the Social Security Act, 42 U.S.C. 1395dd)) that is within the capability of the emergency department of a hospital, including ancillary services routinely available to the emergency department to evaluate an emergency medical condition (as defined in clause (i)) and also, within the capabilities of the staff and facilities at the hospital, such further medical examination and treatment as are required under section 1867 of such Act to stabilize the patient; or "(II) with respect to an emergency medical condition described in clause (i)(II), medical treatment for such condition rendered by a health care provider in a hospital to a neonate, including available hospital ancillary services in response to an urgent request of a health care professional and to the extent necessary to stabilize the neonate. "(iii) EMERGENCY AMBULANCE SERVICES.— The term 'emergency ambulance services' means ambulance services (as defined for purposes of section 1861(s)(7) of the Social Security Act) furnished to transport an individual who has an emergency medical condition (as defined in clause (i)) to a hospital for the receipt of emergency services (as defined in clause (ii)) in a case in which appropriate emergency medical screening examinations are covered under the plan pursuant to paragraph (1)(A) and a prudent layperson, with an average knowledge of health and medicine, could reasonably expect that the absence of such transport would result in placing the health of the individual in serious jeopardy, serious impairment of bodily function, or serious dysfunction of any bodily organ or part. "(iv) STABILIZE.-The term 'to stabilize' means, with respect to an emergency medical condition, to provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a facility. "(v) NONPARTICIPATING.-The term 'nonparticipating' means, with respect to a health care provider that provides health care items and services to a participant or beneficiary under group health plan, a health care provider that is not a participating health care provider with respect to such items and services. "(vi) PARTICIPATING.-The term 'participating' means, with respect to a health care provider that provides health care items and services to a participant or beneficiary under group health plan, a health care provider that furnishes such items and services under a contract or other arrangement with the plan. "(c) PATIENT RIGHT TO OBSTETRIC AND GYNECOLOGICAL CARE. "(1) IN GENERAL.-In any case in which a group health plan "(A) provides benefits under the terms of the plan consisting of "(i) gynecological care (such as preventive women's health examinations); or "(ii) obstetric care (such as pregnancy-related services), provided by a participating health care professional who specializes in such care (or provides benefits consisting of payment for such care); and "(B) requires or provides for designation by a participant or beneficiary of a participating primary care provider, if the primary care provider designated by such a participant or beneficiary is not such a health care professional, then the plan shall meet the requirements of paragraph (2). "(2) REQUIREMENTS.-A group health plan meets the requirements of this paragraph, in connection with benefits described in paragraph (1) consisting of care described in clause (i) or (ii) of paragraph (1)(A) (or consisting of payment therefor), if the plan "(A) does not require authorization or a referral by the primary care provider in order to obtain such benefits; and "(B) treats the ordering of other care of the same type, by the participating health care professional providing the care described in clause (i) or (ii) of paragraph (1)(A), as the authorization of the primary care provider with respect to such care. "(3) HEALTH CARE PROFESSIONAL DEFINED.— For purposes of this subsection, the term 'health care professional' means an individual (including, but not limited to, a nurse midwife or nurse practitioner) who is licensed, accredited, or certified under State law to provide obstetric and gynecological health care services and who is operating within the scope of such licensure, accreditation, or certification. "(4) CONSTRUCTION.-Nothing in paragraph (1) shall be construed as preventing a plan from offering (but not requiring a participant or beneficiary to accept) a health care professional trained, credentialed, and operating within the scope of their licensure to perform obstetric and gynecological health care services. Nothing in paragraph (2)(B) shall waive any requirements of coverage relating to medical necessity or appropriateness with respect to coverage of gynecological or obstetric care so ordered. **(5) TREATMENT OF MULTIPLE COVERAGE OPTIONS. In the case of a plan providing benefits under two or more coverage options, the requirements of this subsection shall apply separately with respect to each coverage option. "(d) PATIENT RIGHT TO PEDIATRIC CARE. "(1) IN GENERAL.-In any case in which a group health plan provides benefits consisting of routine pediatric care provided by a participating health care professional who specializes in pediatrics (or consisting of payment for such care) and the plan requires or provides for designation by a participant or beneficiary of a participating primary care provider, the plan shall provide that such a participating health care professional may be designated, if available, by a parent or guardian of any beneficiary under the plan is who under 18 years of age, as the primary care provider with respect to any such benefits. “(2) HEALTH CARE PROFESSIONAL DEFINED.— For purposes of this subsection, the term 'health care professional' means an individual (including, but not limited to, a nurse practitioner) who is licensed, accredited, or certified under State law to provide pediatric health care services and who is operating within the scope of such licensure, accreditation, or certification. "(3) CONSTRUCTION.-Nothing in paragraph (1) shall be construed as preventing a plan from offering (but not requiring a participant or beneficiary to accept) a health care professional trained, credentialed, and operating within the scope of their licensure to perform pediatric health care services. Nothing in paragraph (1) shall waive any requirements of coverage relating to medical necessity or appropriateness with respect to coverage of pediatric care so ordered. “(4) TREATMENT OF MULTIPLE COVERAGE OPTIONS. In the case of a plan providing benefits under two or more coverage options, the requirements of this subsection shall apply separately with respect to each coverage option. "(e) CONTINUITY OF CARE.“(1) IN GENERAL. "(A) TERMINATION OF PROVIDER.-If a contract between a group health plan and a health care provider is terminated (as defined in subparagraph (D)(ii)), or benefits provided by a health care provider are terminated because of a change in the terms of provider participation in a group health plan, and an individual who, at the time of such termination, is a participant or beneficiary in the plan and is scheduled to undergo surgery (including an organ transplantation), is undergoing treatment for pregnancy, or is determined to be terminally ill (as defined in section 1861(dd)(3)(A) of the Social Security Act) and is undergoing treatment for the terminal illness, the plan shall "(i) notify the individual on a timely basis of such termination and of the right to elect continuation of coverage of treatment by the provider under this subsection; and "(ii) subject to paragraph (3), permit the individual to elect to continue to be covered with respect to treatment by the provider for such surgery, pregnancy, or illness during a transitional period (provided under paragraph (2)). "(B) TREATMENT OF TERMINATION OF CONTRACT WITH HEALTH INSURANCE ISSUER.—If a contract for the provision of health insurance coverage between a group health plan and a health insurance issuer is terminated and, as a result of such termination, coverage of services of a health care provider is terminated with respect to an individual, the provisions of subparagraph (A) (and the succeeding provisions of this subsection) shall apply under the plan in the same manner as if there had been a contract between the plan and the provider that had been terminated, but only with respect to benefits that are covered under the plan after the contract termination. "(C) TERMINATION DEFINED.-For purposes of this subsection, the term 'terminated' includes, with respect to a contract, the expiration or nonrenewal of the contract, but does not include a termination of the contract by the plan for failure to meet applicable quality standards or for fraud. "(2) TRANSITIONAL PERIOD.— "(A) IN GENERAL.-Except as provided in subparagraphs (B) through (D), the transitional period under this paragraph shall extend up to 90 days (as determined by the treating health care professional) after the date of the notice described in paragraph (1)(A)(i) of the provider's termination. "(B) SCHEDULED SURGERY.-If surgery was scheduled for an individual before the date of the announcement of the termination of the provider status under paragraph (1)(A)(i), the transitional period under this paragraph with respect to the surgery or transplantation. "(C) PREGNANCY.—If— "(i) a participant or beneficiary was determined to be pregnant at the time of a provider's termination of participation, and "(ii) the provider was treating the pregnancy before date of the termination, the transitional period under this paragraph with respect to provider's treatment of the pregnancy shall extend through the provision of post-partum care directly related to the delivery. "(D) TERMINAL ILLNESS.-If— "(i) 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 "(ii) the provider was treating the terminal illness before the date of termination, the transitional period under this paragraph shall extend for the remainder of the individual's life for care directly related to the treatment of the terminal illness or its medical manifestations. "(3) PERMISSIBLE TERMS AND CONDITIONS.— A group health plan may condition coverage of continued treatment by a provider under paragraph (1)(A)(i) upon the individual notifying the plan of the election of continued coverage and upon the provider agreeing to the following terms and conditions: "(A) The 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, in the case described in paragraph (1)(B), at the rates applicable under the replacement plan after the date of the termination of the contract with the health insurance issuer) 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 paragraph (1)(A) had not been terminated. "(B) The provider agrees to adhere to the quality assurance standards of the plan responsible for payment under subparagraph (A) and to provide to such plan necessary medical information related to the care provided. "(C) The 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) The provider agrees to provide transitional care to all participants and beneficiaries who are eligible for and elect to have coverage of such care from such provider. "(E) If the provider initiates the termination, the provider has notified the plan within 30 days prior to the effective date of the termination of— "(i) whether the provider agrees to permissible terms and conditions (as set forth in this paragraph) required by the plan, and "(ii) if the provider agrees to the terms and conditions, the specific plan beneficiaries and participants undergoing a course treatment from the provider who the provider believes, at the time of the notification, would be eligible for transitional care under this subsection. "(4) CONSTRUCTION.-Nothing in this subsection shall be construed to— "(A) require the coverage of benefits which would not have been covered if the provider involved remained a participating provider, or "(B) prohibit a group health plan from conditioning a provider's participation on the provider's agreement to provide transitional care to all participants and beneficiaries eligible to obtain coverage of such care furnished by the provider as set forth under this subsection. "(f) COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CANCER CLINICAL TRIALS. "(1) COVERAGE.— "(A) IN GENERAL.-If a group health plan provides coverage to a qualified individual (as defined in paragraph (2)), the plan "(i) may not deny the individual participation in the clinical trial referred to in paragraph (2)(B); "(ii) subject to paragraphs (2), (3), and (4), 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 "(iii) may not discriminate against the individual on the basis of the participation of the participant or beneficiary in such trial. "(B) EXCLUSION OF CERTAIN COSTS.-For purposes of subparagraph (A)(ii), routine patient costs do not include the cost of the tests or measurements conducted primarily for the purpose of the clinical trial involved. "(C) USE OF IN-NETWORK PROVIDERS.-If one or more participating providers is participating in a clinical trial, nothing in subparagraph (A) 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. "(2) QUALIFIED INDIVIDUAL DEFINED.—For purposes of paragraph (1), the term 'qualified individual' means an individual who is a participant or beneficiary in a group health plan and who meets the following conditions: "(A)(i) The individual has been diagnosed with cancer. "(ii) The individual is eligible to participate in an approved clinical trial according to the trial protocol with respect to treatment of cancer. "(iii) The individual's participation in the trial offers meaningful potential for significant clinical benefit for the individual. "(B) Either "(i) 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 satisfaction by the individual of the conditions described in subparagraph (A); or “(ii) the individual provides medical and scientific information establishing that the individual's participation in such trial would be appropriate based upon the satisfaction by the individual of the conditions described in subparagraph (A). "(3) PAYMENT.— "(A) IN GENERAL.-A group health plan shall provide for payment for routine patient costs described in paragraph (1)(B) 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. “(B) ROUTINE PATIENT CARE COSTS. "(i) IN GENERAL.-For purposes of this paragraph, the term 'routine patient care costs' shall include the costs associated with the provision of items and services that— "(I) would otherwise be covered under the group health plan if such items and services were not provided in connection with an approved clinical trial program; and “(II) are furnished according to the protocol of an approved clinical trial program. "(ii) EXCLUSION.-For purposes of this paragraph, ‘routine patient care costs' shall not include the costs associated with the provision of— (I) an investigational drug or device, unless the Secretary has authorized the manufacturer of such drug or device to charge for such drug or device; or (II) any item or service supplied without charge by the sponsor of the approved clinical trial program. "(C) PAYMENT RATE.-For purposes of this subsection "(i) PARTICIPATING PROVIDERS.-In the case of covered items and services provided by a participating provider, the payment rate shall be at the agreed upon rate. “(ii) NONPARTICIPATING PROVIDERS.—In the case of covered items and servicesprovided by a nonparticipating provider, the payment rate shall be at the rate the plan would normally pay for comparable items or services under clause (i). "(4) APPROVED CLINICAL TRIAL DEFINED.— "(A) IN GENERAL.-For purposes of this subsection, the term 'approved clinical trial' means a cancer clinical research study or cancer clinical investigation approved by an Institutional Review Board. "(B) CONDITIONS FOR DEPARTMENTS.—The conditions described in this paragraph, for a 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 "(i) to be comparable to the system of peer review of studies and investigations used by the National Institutes of Health, and "(ii) assures unbiased review of the highest scientific standards by qualified individuals who have no interest in the outcome of the review. "(5) CONSTRUCTION.-Nothing in this subsection shall be construed to limit a plan's coverage with respect to clinical trials. "(6) PLAN SATISFACTION OF CERTAIN REQUIREMENTS; RESPONSIBILITIES OF FIDUCIARIES. "(A) IN GENERAL.-For purposes of this subsection, 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 subsection 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. "(B) CONSTRUCTION.-Nothing in this subsection shall be construed to affect or modify the responsibilities of the fiduciaries of a group health plan under part 4 of subtitle B of title I of the Employee Retirement Income Security Act of 1974. "(7) STUDY AND REPORT. "(A) STUDY.-The Secretary shall analyze cancer clinical research and its cost implications for managed care, including differentiation in "(i) the cost of patient care in trials versus standard care; "(ii) the cost effectiveness achieved in different sites of service; "(iii) research outcomes; “(iv) volume of research subjects available in different sites of service; "(v) access to research sites and clinical trials by cancer patients; "(vi) patient cost sharing or copyament costs realized in different sites of service; "(vii) health outcomes experienced in different sites of service; "(viii) long term health care services and costs experienced in different sites of service; "(ix) morbidity and mortality experienced in different sites of service; and "(x) patient satisfaction and preference of sites of service. "(B) REPORT TO CONGRESS.-Not later than January 1, 2005, the Secretary shall submit a report to Congress that contains “(i) an assessment of any incremental cost to group health plans resulting from the provisions of this section; "(ii) a projection of expenditures to such plans resulting from this section; "(iii) an assessment of any impact on premiums resulting from this section; and "(iv) recommendations regarding action on other diseases.". SEC. 302. EFFECTIVE DATE AND RELATED RULES. (a) IN GENERAL.-The amendments made by this title 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, except that the Secretary of the Treasury may issue regulations before such date under such amendments. The Secretary shall first issue regulations necessary to carry out the amendments made by this title before the effective date thereof. (b) LIMITATION ON ENFORCEMENT ACTIONS.— No enforcement action shall be taken, pursuant to the amendments made by this title, 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. (c) 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 title shall not apply with respect to plan years beginning before the later of (1) 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 (2) January 1, 2002. For purposes of this subsection, any plan amendment made pursuant to a collective bargaining agreement relating to the plan which amends the plan solely to conform to any requirement added by this title shall not be treated as a termination of such collective bargaining agreement. TITLE IV-HEALTH CARE LAWSUIT REFORM Subtitle A-General Provisions SEC. 401. FEDERAL REFORM OF HEALTH CARE LIABILITY ACTIONS. (a) APPLICABILITY.-This title shall apply with respect to any health care liability action brought in any State or Federal court, except that this title shall not apply to (1) an action for damages arising from a vaccine-related injury or death to the extent that title XXI of the Public Health Service Act applies to the action; (2) an action under the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1001 et seq.); or (3) an action in connection with benefits which are not included group health plan benefits (as defined in section 402(14)). (b) PREEMPTION. This title shall preempt any State law to the extent such law is inconsistent with the limitations contained in this title. This title shall not preempt any State law that provides for defenses or places limitations on a person's liability in addition to those contained in this title or otherwise imposes greater restrictions than those provided in this title. (c) EFFECT ON SOVEREIGN IMMUNITY AND CHOICE OF LAW OR VENUE.-Nothing in subsection (b) shall be construed to (1) waive or affect any defense of sovereign immunity asserted by any State under any provision of law; (2) waive or affect any defense of sovereign immunity asserted by the United States; (3) affect the applicability of any provision of the Foreign Sovereign Immunities Act of 1976: (4) preempt State choice-of-law rules with respect to claims brought by a foreign nation or a citizen of a foreign nation; or (5) affect the right of any court to transfer venue or to apply the law of a foreign nation or to dismiss a claim of a foreign nation or of a citizen of a foreign nation on the ground of inconvenient forum. (d) AMOUNT IN CONTROVERSY.-In an action to which this title applies and which is brought under section 1332 of title 28, United States Code, the amount of non-economic damages or punitive damages, and attorneys' fees or costs, shall not be included in determining whether the matter in controversy exceeds the sum or value of $50,000. (e) FEDERAL COURT JURISDICTION NOT ESTABLISHED ON FEDERAL QUESTION GROUNDS.— Nothing in this title shall be construed to establish any jurisdiction in the district courts of the United States over health care liability actions on the basis of section 1331 or 1337 of title 28, United States Code. SEC. 402. DEFINITIONS. As used in this title: (1) ACTUAL DAMAGES.-The term "actual damages" means damages awarded to pay for economic loss. (2) ALTERNATIVE DISPUTE RESOLUTION SYSTEM; ADR.-The term "alternative dispute resolution system" or "ADR" means a system established under Federal or State law that provides for the resolution of health care liability claims in a manner other than through health care liability actions. CLAIMANT.-The (3) term "claimant" means any person who brings a health care liability action and any person on whose behalf such an action is brought. If such action is brought through or on behalf of an estate, the term includes the claimant's decedent. If such action is brought through or on behalf of a minor or incompetent, the term includes the claimant's legal guardian. (4) CLEAR AND CONVINCING EVIDENCE.—The term "clear and convincing evidence" is that measure or degree of proof that will produce in the mind of the trier of fact a firm belief or conviction as to the truth of the allegations sought to be established. Such measure or degree of proof is more than that required under preponderance of the evidence but less than that required for proof beyond a reasonable doubt. (5) COLLATERAL SOURCE PAYMENTS.-The term "collateral source payments" means any amount paid or reasonably likely to be paid in the future to or on behalf of a claimant, or any service, product, or other benefit provided or reasonably likely to be provided in the future to or on behalf of a claimant, as a result of an injury or wrongful death, pursuant to (A) any State or Federal health, sickness, income-disability, accident or workers' compensation Act; (B) any health, sickness, income-disability, or accident insurance that provides health benefits or income-disability coverage; (C) any contract or agreement of any group, organization, partnership, or corporation to provide, pay for, or reimburse the cost of medical, hospital, dental, or income disability benefits; and (D) any other publicly or privately funded. program. (6) DRUG.-The term "drug" has the meaning given such term in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)). (7) ECONOMIC LOSS.-The term "economic loss" means any pecuniary loss resulting from injury (including the loss of earnings or other benefits related to employment, medical expense loss, replacement services loss, loss due to death, burial costs, and loss of business or employment opportunities), to the extent recovery for such loss is allowed under applicable State law. (8) HARM. The term "harm" means any legally cognizable wrong or injury for which punitive damages may be imposed. (9) HEALTH BENEFIT PLAN. The term "health benefit plan" means (A) a hospital or medical expense incurred policy or certificate; (B) a hospital or medical service plan contract; (C) a health maintenance subscriber contract; or (D) a Medicare+Choice plan (offered under part C of title XVIII of the Social Security Act), that provides benefits with respect to health care services. (10) HEALTH CARE LIABILITY ACTION.-The term "health care liability action" means a civil action brought in a State or Federal court against (A) a health care provider; (B) an entity which is obligated to provide or pay for health benefits under any health benefit plan (including any person or entity acting under a contract or arrangement to provide or administer any health benefit); or (C) the manufacturer, distributor, supplier, marketer, promoter, or seller of a medical product, in which the claimant alleges a claim (including third party claims, cross claims, counter claims, or contribution claims) based upon the provision of (or the failure to provide or pay for) health care services or the use of a medical product, regardless of the theory of liability on which the claim is based or the number of plaintiffs, defendants, or causes of action. (11) HEALTH CARE LIABILITY CLAIM.-The term "health care liability claim" means a claim in which the claimant alleges that injury was caused by the provision of (or the failure to provide) health care services. (12) HEALTH CARE PROVIDER.-The term "health care provider" means any person that is engaged in the delivery of health care services in a State and that is required by the laws or regulations of the State to be licensed or certified by the State to engage in the delivery of such services in the State. (13) HEALTH CARE SERVICE.-The term "health care service" means any service eligible for payment under a health benefit plan, including services related to the delivery or administration of such service. (14) INCLUDED GROUP HEALTH PLAN BENEFIT. The term 'included group health plan benefit' means a benefit under a group health plan which is not an excepted benefit (as defined in section 733(c) of the Employee Retirement Income Security Act of 1974). (15) MEDICAL DEVICE.-The term "medical device" has the meaning given such term in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)). (16) NON-ECONOMIC DAMAGES.-The term "non-economic damages" means damages paid to an individual for pain and suffering, inconvenience, emotional distress, mental anguish, loss of consortium, injury to reputation, humiliation, and other nonpecuniary losses. (17) PERSON.-The term "person" means any individual, corporation, company, association, firm, partnership, society, joint stock company, or any other entity, including any governmental entity. (18) PRODUCT SELLER. (A) IN GENERAL.-Subject to subparagraph (B), the term "product seller" means a person who, in the course of a business conducted for that purpose (i) sells, distributes, rents, leases, prepares, blends, packages, labels, or is otherwise involved in placing, a product in the stream of commerce; or (ii) installs, repairs, or maintains the harm-causing aspect of a product. (B) EXCLUSION.-Such term does not include (i) a seller or lessor of real property; (ii) a provider of professional services in any case in which the sale or use of a product is incidental to the transaction and the essence of the transaction is the furnishing of judgment, skill, or services; or (iii) any person who (I) acts in only a financial capacity with respect to the sale of a product; or (II) leases a product under a lease arrangement in which the selection, possession, maintenance, and operation of the product are controlled by a person other than the les sor. (19) PUNITIVE DAMAGES.-The term "punitive damages" means damages awarded against any person not to compensate for actual injury suffered, but to punish or deter such person or others from engaging in similar behavior in the future. (20) STATE. The term "State" means each of the several States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, the Northern Mariana Islands, and any other territory or possession of the United States. SEC. 403. EFFECTIVE DATE. This title will apply to (1) any health care liability action brought in a Federal or State court; and (2) any health care liability claim subject to an alternative dispute resolution system, that is initiated on or after the date of enactment of this title, except that any health care liability claim or action arising from an injury occurring before the date of enactment of this title shall be governed by the applicable statute of limitations provisions in effect at the time the injury occurred. Subtitle B-Uniform Standards for Health Care Liability Actions SEC. 411. STATUTE OF LIMITATIONS. A health care liability action may not be brought after the expiration of the 2-year period that begins on the date on which the alleged injury that is the subject of the action was discovered or should reasonably have been discovered, but in no case after the expiration of the 5-year period that begins on the date the alleged injury occurred. SEC. 412. CALCULATION AND PAYMENT OF DAMAGES. (a) TREATMENT OF NON-ECONOMIC DAMAGES. (1) LIMITATION ON NON-ECONOMIC DAMAGES.— The total amount of non-economic damages that may be awarded to a claimant for losses resulting from the injury which is the subject of a health care liability action may not exceed $250,000, regardless of the number of parties against whom the action is brought or the number of actions brought with respect to the injury. The limitation under this paragraph shall not apply to an action for damages based solely on intentional denial of medical treatment necessary to preserve a patient's life that the patient is otherwise qualified to receive, against the wishes of a patient, or if the patient is incompetent, against the wishes of the patient's guardian, on the basis of the patient's present or predicated age, disability, degree of medical dependency, or quality of life. (2) LIMIT.-If, after the date of the enactment of this Act, a State enacts a law which prescribes the amount of non-economic damages which may be awarded in a health care liability action which is different from the amount prescribed by section 412(a)(1), the State amount shall apply in lieu of the amount prescribed by such section. If, after the date of the enactment of this Act, a State enacts a law which limits the amount of recovery in a health care liability action without delineating between economic and non-economic damages, the State amount shall apply in lieu of the amount prescribed by such section. (3) JOINT AND SEVERAL LIABILITY.—In any health care liability action brought in State or Federal court, a defendant shall be liable only for the amount of non-economic damages attributable to such defendant in direct proportion to such defendant's share of fault or responsibility for the claimant's actual damages, as determined by the trier of fact. In all such cases, the liability of a defendant for non-economic damages shall be several and not joint and a separate judgment shall be rendered against each defendant for the amount allocated to such defendant. (b) TREATMENT OF PUNITIVE DAMAGES.— (1) GENERAL RULE.-Punitive damages may, to the extent permitted by applicable State law, be awarded in any health care liability action for harm in any Federal or State court against a defendant if the claimant establishes by clear and convincing evidence that the harm suffered was the result of conduct (A) specifically intended to cause harm; or (B) conduct manifesting a conscious, flagrant indifference to the rights or safety of others. (2) APPLICABILITY.-This subsection shall apply to any health care liability action brought in any Federal or State court on any theory where punitive damages are sought. This subsection does not create a cause of action for punitive damages. (3) LIMITATION ON PUNITIVE DAMAGES.-The total amount of punitive damages that may be awarded to a claimant for losses resulting from the injury which is the subject of a health care liability action may not exceed the greater of (A) 2 times the amount of economic damages, or (B) $250,000, regardless of the number of parties against whom the action is brought or the number of actions brought with respect to the injury. This subsection does not preempt or supersede any State or Federal law to the extent that such law would further limit the award of punitive damages. (4) BIFURCATION.-At the request of any party, the trier of fact shall consider in a separate proceeding whether punitive damages are to be awarded and the amount of such award. If a separate proceeding is requested, evidence relevant only to the claim of punitive damages, as determined by applicable State law, shall be inadmissible in any proceeding to determine whether actual damages are to be awarded. (4) DRUGS AND DEVICES.— (A) IN GENERAL.— (i) PUNITIVE DAMAGES.-Punitive damages shall not be awarded against a manufacturer or product seller of a drug or medical device which caused the claimant's harm where (I) such drug or device was subject to premarket approval by the Food and Drug Administration with respect to the safety of the formulation or performance of the aspect of such drug or device which caused the claimant's harm, or the adequacy of the packaging or labeling of such drug or device which caused the harm, and such drug, device, packaging, or labeling was approved by the Food and Drug Administration; or (II) the drug is generally recognized as safe and effective pursuant to conditions established by the Food and Drug Administration and applicable regulations, including packaging and labeling regulations. (ii) APPLICATION.-Clause (i) shall not apply in any case in which the defendant, before or after premarket approval of a drug or device (I) intentionally and wrongfully withheld from or misrepresented to the Food and Drug Administration information concerning such drug or device required to be submitted under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the Public Health Service Act (42 U.S.C. 262) that is material and relevant to the harm suffered by the claimant; or (II) made an illegal payment to an official or employee of the Food and Drug Administration for the purpose of securing or maintaining approval of such drug or device. (B) PACKAGING.-In a health care liability action for harm which is alleged to relate to the adequacy of the packaging or labeling of a drug which is required to have tamper-resistant packaging under regulations of the Secretary of Health and Human Services (including labeling regulations related to such packaging), the manufacturer or product seller of the drug shall not be held liable for punitive damages unless such packaging or labeling is found by the court by clear and convincing evidence to be substantially out of compliance with such regulations. (c) PERIODIC PAYMENTS FOR FUTURE LOSSES. (1) GENERAL RULE.-In any health care liability action in which the damages awarded for future economic and non-economic loss exceeds $50,000, a person shall not be required to pay such damages in a single, lump-sum payment, but shall be permitted to make such payments periodically based on when the damages are likely to occur, as such payments are determined by the court. (2) FINALITY OF JUDGMENT.-The judgment of the court awarding periodic payments under this subsection may not, in the absence of fraud, be reopened at any time to contest, amend, or modify the schedule or amount of the payments. (3) LUMP-SUM SETTLEMENTS.-This subsection shall not be construed to preclude a settlement providing for a single, lump-sum payment. (d) TREATMENT OF COLLATERAL SOURCE PAYMENTS. (1) INTRODUCTION INTO EVIDENCE.-In any health care liability action, any defendant may introduce evidence of collateral source payments. If any defendant elects to introduce such evidence, the claimant may introduce evidence of any amount paid or contributed or reasonably likely to be paid or contributed in the future by or on behalf of the claimant to secure the right to such collateral source payments. (2) NO SUBROGATION.-No provider of collateral source payments shall recover any amount against the claimant or receive any lien or credit against the claimant's recovery or be equitably or legally subrogated to the right of the claimant in a health care liability action. (3) APPLICATION TO SETTLEMENTS.-This subsection shall apply to an action that is settled as well as an action that is resolved by a fact finder. SEC. 413. ALTERNATIVE DISPUTE RESOLUTION. Any ADR used to resolve a health care liability action or claim shall contain provisions relating to statute of limitations, noneconomic damages, joint and several liability, punitive damages, collateral source rule, and periodic payments which are consistent with the provisions relating to such matters in this title. SEC. 414. REPORTING ON FRAUD AND ABUSE ENFORCEMENT ACTIVITIES. The General Accounting Office shall(1) monitor (A) the compliance of the Department of Justice and all United States Attorneyswith the guideline entitled "Guidance on the Use of the False Claims Act in Civil Health Care Matters" issued by the Department on June 3, 1998, including any revisions to that guideline; and (B) the compliance of the Office of the Inspector General of the Department of Health and Human Services with the protocols and 1 TITLE I AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT Sec. 101. Application to group health plans and group health insurance coverage. Sec. 102. Application to individual health insurance coverage. guidelines entitled "National Project Protocols-Best Practice Guidelines" issued by the Inspector General on June 3, 1998, including any revisions to such protocols and guidelines; and (2) submit a report on such compliance to the Committee on Commerce, the Committee on the Judiciary, and the Committee on Ways and Means of the House of Representatives and the Committee on the Judiciary and the Committee on Finance of the Senate not later than February 1, 2000, and every year thereafter for a period of 4 years ending February 1, 2003. It was decided in the negative ¶110.8 Green (TX) Greenwood Yeas Nays 145 Gonzalez ....... Gordon Graham [Roll No. 487] AYES-145 Goodling Goss Granger Paul Pease Ramstad Sherman Shows Sisisky Skeen Skelton Slaughter Smith (NJ) Smith (WA) Tanner Tauscher Thompson (MS) Thornberry Thurman Towns Turner Udall (CO) Udall (NM) Velázquez Vento Watt (NC) Waxman Weiner Wexler Weygand Hall (OH) Aderholt Archer Hall (TX) Menendez Hastings (FL) Millender Snyder Hill (IN) McDonald Souder Stenholm Strickland Stupak Riley Rogers Rohrabacher Sensenbrenner Sherwood Shimkus Chambliss Kasich Pascrell Pastor Payne Pelosi Wamp DeLay Taylor (NC) Terry Thomas Lantos Largent Lazio Weldon (FL) Leach Woolsey Wu Gillmor Ose Young (AK) Lee Levin Roemer Rogan So the amendment in the nature of a substitute was not agreed to. After some further time, $110.9 RECORDED VOTE A recorded vote by electronic device was ordered in the Committee of the Whole on the following amendment in the nature of a substitute submitted by Mr. GOSS: Strike all after the enacting clause and insert the following: SECTION 1. SHORT TITLE; TABLE OF CONTENTS. (a) SHORT TITLE.-This Act may be cited as the "Health Care Quality and Choice Act of 1999". (b) TABLE OF CONTENTS.-The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 103. Improving managed care. "TITLE XXVIII-IMPROVING MANAGED CARE "Subtitle A-Grievance and Appeals process. "Subtitle B-Access to Care "Sec. 2811. Consumer choice option. "Sec. 2812. Choice of health care profes sional. "Sec. 2813. Access to emergency care. "Sec. 2816. Access to pediatric care. "Sec. 2819. Access to experimental or investigational prescription drugs. "Sec. 2820. Coverage for individuals participating in approved cancer clinical trials. "Subtitle C-Access to Information "Sec. 2821. Patient access to informa tion. "Subtitle D-Protecting the Doctor-Patient Relationship "Sec. 2831. Prohibition of interference with certain medical communications. "Sec. 2832. Prohibition of discrimination against providers based on li censure. "Sec. 2833. Prohibition against improper incentive arrangements. "Sec. 2834. Payment of clean claims. "Subtitle E-Definitions "Sec. 2841. Definitions. "Sec. 2842. Rule of construction. "Sec. 2843. Exclusions. "Sec. 2844. Coverage of limited scope plans. "Sec. 2845. Regulations. "Sec. 2846. Limitation on application of provisions relating to group health plans.. TITLE II-AMENDMENTS TO THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974 Sec. 201. Application of patient protection standards to group health plans and group health insurance coverage under the Employee Retirement Income Security Act of 1974. Sec. 202. Improving managed care. "PART 8—IMPROVING MANAGED CARE "SUBPART A-GRIEVANCE AND APPEALS "Sec. 801. Utilization review activities. "Sec. 802. Internal appeals procedures. "Sec. 803. External appeals procedures. "Sec. 804. Establishment of a grievance process. "SUBPART B-ACCESS TO CARE "Sec. 812. Choice of health care professional. "Sec. 813. Access to emergency care. "Sec. 814. Access to specialty care. "Sec. 815. Access to obstetrical and gyn ecological care. "Sec. 816. Access to pediatric care. "Sec. 817. Continuity of care. "Sec. 818. Network adequacy. |