[Congressional Record (Bound Edition), Volume 145 (1999), Part 11]
[Senate]
[Pages 15647-15655]
[From the U.S. Government Publishing Office, www.gpo.gov]




                          AMENDMENTS SUBMITTED

                                 ______
                                 

                      PATIENTS' BILL OF RIGHTS ACT

                                 ______
                                 

                NICKLES (AND OTHERS) AMENDMENT NO. 1236

  Mr. NICKLES (for himself, Mr. Gramm, and Ms. Collins) proposed an 
amendment to the bill (S. 1344) to amend the Public Health Service Act, 
the Employee Retirement Income Security Act of 1974, and the Internal 
Revenue Code of 1986 to protect consumers in managed care plans and 
other health coverage; as follows:

       At the appropriate place, insert the following:

     SEC. __. EXEMPTIONS.

       (a) In General.--Notwithstanding any other provision of 
     this Act, the provisions of this Act shall not apply with 
     respect to a group health plan (or health insurance coverage 
     offered in connection with the group health plan) if the 
     provisions of this Act for a plan year during which this Act 
     is fully implemented result in--
       (1) a greater than 1 percent increase in the cost of the 
     group health plan's premiums for the plan year, as determined 
     under subsection (b); or
       (2) a decrease, in the plan year, of 100,000 or more in the 
     number of individuals in the United States with private 
     health insurance, as determined under subsection (c).
       (b) Exemption for Increased Cost.--For purposes of 
     subsection (a)(1), if an actuary certified in accordance with 
     generally recognized standards of actuarial practice by a 
     member of the American Academy of Actuaries or by another 
     individual whom the Secretary has determined to have an 
     equivalent level of training and expertise certifies that the 
     application of this Act to a group health plan (or health 
     insurance coverage offered in connection with the group 
     health plan) will result in the increase described in 
     subsection (a)(1) for a plan year during which this Act is 
     fully implemented, the provisions of this Act shall not apply 
     with respect to the group health plan (or the coverage).
       (c) Exemption for Decreased Number of Insured Persons.--For 
     purposes of subsection (a)(2), unless the Administrator of 
     the Health Care Financing Administration certifies, on the 
     basis of projections by the National Association of Insurance 
     Commissioners, that the provisions of this Act will not 
     result in the decrease described in subsection (a)(2) for a 
     plan year during which this Act is fully implemented, the 
     provisions of this Act shall not apply with respect to a 
     group health plan (or health insurance coverage offered in 
     connection with a group health plan).
                                 ______
                                 

                  ROBB (AND OTHERS) AMENDMENT NO. 1237

  Mr. KENNEDY (for Mr. Robb (for himself, Mrs. Murray, Mrs. Boxer, Ms. 
Mikulski, Mr. Kennedy, Mr. Reid, Mr. Durbin, Mr. Feingold, Mrs. 
Lincoln, Mr. Daschle, Mr. Byrd, Mr. Lieberman, Mr. Bingaman, Mr. Bryan, 
and Mr. Harkin)) proposed an amendment to amendment No. 1236 proposed 
by Mr. Nickles to the bill, S. 1344, supra; as follows:

       In the amendment, strike all after the first word and 
     insert the following: standards relating to benefits for 
     certain breast cancer treatment and access to appropriate 
     obstetrical and gynecological care.
       (a) Breast Cancer Treatment.--
       (1) Inpatient care.--A group health plan, or a health 
     insurance issuer in connection with group health insurance 
     coverage, 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 his or her 
     professional judgment consistent with generally accepted 
     medical standards, and the patient, to be medically 
     appropriate following--
       (A) a mastectomy;
       (B) a lumpectomy; or
       (C) a lymph node dissection for the treatment of breast 
     cancer.
       (2) Prohibitions.--A group health plan, or a health 
     insurance issuer in connection with group health insurance 
     coverage, may not--
       (A) deny to a patient eligibility, or continued 
     eligibility, to enroll or to renew coverage under the terms 
     of the plan or coverage, solely for the purpose of avoiding 
     the requirements of this subsection;
       (B) provide monetary payments or rebates to patients to 
     encourage such patients to accept less than the minimum 
     protections available under this subsection;
       (C) penalize or otherwise reduce or limit the reimbursement 
     of an attending provider because such provider provided care 
     to an individual participant, beneficiary or enrollee in 
     accordance with this subsection;
       (D) provide incentives (monetary or otherwise) to an 
     attending provider to induce such provider to provide care to 
     an individual participant, beneficiary or enrollee in a 
     manner inconsistent with this subsection; or
       (E) subject to paragraph (3)(B), restrict benefits for any 
     portion of a period within a hospital length of stay required 
     under paragraph (1) in a manner which is less favorable than 
     the benefits provided for any preceding portion of such stay.
       (3) Rules of construction.--
       (A) Nothing in this subsection shall be construed to 
     require a patient who is a participant, beneficiary or 
     enrollee--
       (i) to undergo a mastectomy, lumpectomy or lymph node 
     dissection in a hospital; or
       (ii) to stay in the hospital for a fixed period of time 
     following a mastectomy, lumpectomy or lymph node dissection.
       (B) Nothing in this subsection shall be construed as 
     preventing a group health plan or a health insurance issuer 
     from imposing deductibles, coinsurance, or other cost-sharing 
     in relation to benefits for hospital lengths of stay in 
     connection with a mastectomy, lumpectomy or lymph node 
     dissection for the treatment of breast cancer under the plan 
     except that such coinsurance or other cost-sharing for any 
     portion of a period within a hospital length of stay required 
     under paragraph (1) may not be greater than such coinsurance 
     or cost-sharing for any preceding portion of such stay.
       (4) Level and type of reimbursements.--Nothing in this 
     subsection shall be construed to prevent a group health plan 
     or a health insurance issuer from negotiating the level

[[Page 15648]]

     and type of reimbursement with a provider for care provided 
     in accordance with this subsection.
       (5) Definition.--In this subsection, the term 
     ``mastectomy'' means the surgical removal of all or part of a 
     breast.
       (b) Obstetrical and Gynecological Care.--
       (1) In general.--If a group health plan, or a health 
     insurance issuer in connection with the provision of group 
     health insurance coverage, requires or provides for a 
     participant, beneficiary, or enrollee to designate a 
     participating primary care provider--
       (A) the plan or issuer shall permit such an individual who 
     is a female to designate a participating physician who 
     specializes in obstetrics and gynecology as the individual's 
     primary care provider; and
       (B) if such an individual has not designated such a 
     provider as a primary care provider, the plan or issuer--
       (i) shall not require authorization or a referral by the 
     individual's primary care provider or otherwise for coverage 
     of covered gynecological care and pregnancy-related services 
     provided by a participating health care professional who 
     specializes in obstetrics and gynecology to the extent such 
     care is otherwise covered, and
       (ii) shall treat the ordering of other obstetrical and 
     gynecological care by such a participating health 
     professional as the authorization of the primary care 
     provider with respect to such care under the plan or 
     coverage.
       (2) Construction.--Nothing in paragraph (1)(B)(ii) shall 
     waive any requirements of coverage relating to medical 
     necessity or appropriateness with respect to coverage of 
     obstetrical and gynecological care so ordered.
       (c) Special Rule.--Nothing in subsection (b) shall be 
     construed as preventing a plan or issuer 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 gynecological 
     and obstetric care.
       (d) Application of Section.--This section shall supersede 
     the provisions of sections 104(a) and 152.
       (e) Review.--Failure to meet the requirements of this 
     section shall constitute an appealable decision under section 
     132(a)(2).
       (f) Plan Satisfaction of Certain Requirements.--Pursuant to 
     rules of the Secretary, if a health insurance issuer offers 
     health insurance coverage in connection with a group health 
     plan and takes an action in violation of any provision of 
     this subchapter, the group health plan shall not be liable 
     for such violation unless the plan caused such violation.
       (g) Nonapplication of Certain Provision.--Only for purposes 
     of applying the requirements of this section under section 
     714 of the Employee Retirement Income Security Act of 1974 
     (as added by section 301 of this Act), sections 2707 and 2753 
     of the Public Health Service Act (as added by sections 201 
     and 202 of this Act), and section 9813 of the Internal 
     Revenue Code of 1986 (as added by section 401 of this Act)--
       (1) section 2721(b)(2) of the Public Health Service Act and 
     section 9831(a)(1) of the Internal Revenue Code of 1986 shall 
     not apply to the provisions of this section; and
       (2) with respect to limited scope dental benefits, 
     subparagraph (A) of section 733(c)(2) of the Employee 
     Retirement Income Security Act of 1974, subparagraph (A) of 
     section 2791(c)(2) of the Public Health Service Act, and 
     subparagraph (A) of section 9832(c)(2) of the Internal 
     Revenue Code of 1986 shall not apply to the provisions of 
     this section.
       (h) No Impact on Social Security Trust Fund.--
       (1) In general.--Nothing in this section 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 
     section 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 section 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 section.
       (i) Limitation on actions.--
       (1) In general.--Except as provided for in paragraph (2), 
     no action may be brought under subsection (a)(1)(B), (a)(2), 
     or (a)(3) of section 502 by a participant or beneficiary 
     seeking relief based on the application of any provision in 
     this section.
       (2) Permissible actions.--An action may be brought under 
     subsection (a)(1)(B), (a)(2), or (a)(3) of section 502 by a 
     participant or beneficiary seeking relief based on the 
     application of this section to the individual circumstances 
     of that participant or beneficiary; except that--
       (A) such an action may not be brought or maintained as a 
     class action; and
       (B) in such an action relief may only provide for the 
     provision of (or payment for) benefits, items, or services 
     denied to the individual participant or beneficiary involved 
     (and for attorney's fees and the costs of the action, at the 
     discretion of the court) and shall not provide for any other 
     relief to the participant or beneficiary or for any relief to 
     any other person.
       (3) Rule of construction.--Nothing in this subsection shall 
     be construed as affecting any action brought by the 
     Secretary.
       (j) Effective Date.--The provisions of this section shall 
     apply to group health plans for plan years beginning after, 
     and to health insurance issuers for coverage offered or sold 
     after, October 1, 2000.''.
       (k) 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.
       (l) Limitations on Welfare Benefit Funds of 10 or More 
     Employer Plans.--
       (1) Benefits to which exception applies.--Section 
     419A(f)(6)(A) of the Internal Revenue Code of 1986 (relating 
     to exception for 10 or more employer plans) is amended to 
     read as follows:

[[Page 15649]]

       ``(A) In general.--This subpart shall not apply to a 
     welfare benefit fund which is part of a 10 or more employer 
     plan if the only benefits provided through the fund are 1 or 
     more of the following:
       ``(i) Medical benefits.
       ``(ii) Disability benefits.
       ``(iii) Group term life insurance benefits which do not 
     provide for any cash surrender value or other money that can 
     be paid, assigned, borrowed, or pledged for collateral for a 
     loan.

     The preceding sentence shall not apply to any plan which 
     maintains experience-rating arrangements with respect to 
     individual employers.''
       (2) Limitation on use of amounts for other purposes.--
     Section 4976(b) of such Act (defining disqualified benefit) 
     is amended by adding at the end the following new paragraph:
       ``(5) Special rule for 10 or more employer plans exempted 
     from prefunding limits.--For purposes of paragraph (1)(C), 
     if--
       ``(A) subpart D of part I of subchapter D of chapter 1 does 
     not apply by reason of section 419A(f)(6) to contributions to 
     provide 1 or more welfare benefits through a welfare benefit 
     fund under a 10 or more employer plan, and
       ``(B) any portion of the welfare benefit fund attributable 
     to such contributions is used for a purpose other than that 
     for which the contributions were made,

     then such portion shall be treated as reverting to the 
     benefit of the employers maintaining the fund.''
       (3) Effective date.--The amendments made by this subsection 
     shall apply to contributions paid or accrued after the date 
     of the enactment of this Act, in taxable years ending after 
     such date.
       (d) Deduction for Health Insurance Costs of Self-Employed 
     Individuals Increased.--
       (1) In general.--Section 162(l)(1) of the Internal Revenue 
     Code of 1986 (relating to special rules for health insurance 
     costs of self-employed individuals) 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(e)(1), 
     there shall be allowed as a deduction under this section an 
     amount equal to the amount paid during the taxable year for 
     insurance which constitutes medical care for the taxpayer, 
     the taxpayer's spouse, and dependents.''
       (2) Certification of limitations on other coverage.--The 
     first sentence of section 162(l)(2)(B) of the Internal 
     Revenue Code of 1986 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(e)(4)) of the taxpayer 
     or the spouse of the taxpayer.''
       (3) Effective date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     1998.
       (e) Extension of Taxes.--
       (1) Environmental tax.--Section 59A(e) of the Internal 
     Revenue Code of 1986 is amended to read as follows:
       ``(e) Application of Tax.--The tax imposed by this section 
     shall apply to taxable years beginning after December 31, 
     1986, and before January 1, 1996, and to taxable years 
     beginning after December 31, 1999, and before January 1, 
     2009.''
       (2) Effective dates.--The amendment made by subsection 
     (e)(1) shall apply to taxable years beginning after December 
     31, 1999.
                                 ______
                                 

                FRIST (AND JEFFORDS) AMENDMENT NO. 1238

  Mr. NICKLES (for Mr. Frist (for himself and Mr. Jeffords)) proposed 
an amendment to amendment No. 1236 proposed by Mr. Nickles to the bill, 
S. 1344, supra; as follows:

       At the end add the following:
       Notwithstanding any other provision of this Act, subtitle D 
     of title I and all that follows through section 151 is null, 
     void, and shall have no effect.

         Subtitle E--Protecting the Doctor-Patient Relationship

     SEC. 141. PROHIBITION OF INTERFERENCE WITH CERTAIN MEDICAL 
                   COMMUNICATIONS.

       (a) Prohibition.--
       (1) General rule.--The provisions of any contract or 
     agreement, or the operation of any contract or agreement, 
     between a group health plan or health insurance issuer in 
     relation to health insurance coverage (including any 
     partnership, association, or other organization that enters 
     into or administers such a contract or agreement) and a 
     health care provider (or group of health care providers) 
     shall not prohibit or restrict the provider from engaging in 
     medical communications with the provider's patient.
       (2) Nullification.--Any contract provision or agreement 
     that restricts or prohibits medical communications in 
     violation of paragraph (1) shall be null and void.
       (b) Rules of Construction.--Nothing in this section shall 
     be construed--
       (1) to prohibit the enforcement, as part of a contract or 
     agreement to which a health care provider is a party, of any 
     mutually agreed upon terms and conditions, including terms 
     and conditions requiring a health care provider to 
     participate in, and cooperate with, all programs, policies, 
     and procedures developed or operated by a group health plan 
     or health insurance issuer to assure, review, or improve the 
     quality and effective utilization of health care services (if 
     such utilization is according to guidelines or protocols that 
     are based on clinical or scientific evidence and the 
     professional judgment of the provider) but only if the 
     guidelines or protocols under such utilization do not 
     prohibit or restrict medical communications between providers 
     and their patients; or
       (2) to permit a health care provider to misrepresent the 
     scope of benefits covered under the group health plan or 
     health insurance coverage or to otherwise require a group 
     health plan health insurance issuer to reimburse providers 
     for benefits not covered under the plan or coverage.
       (c) Medical Communication Defined.--In this section:
       (1) In general.--The term ``medical communication'' means 
     any communication made by a health care provider with a 
     patient of the health care provider (or the guardian or legal 
     representative of such patient) with respect to--
       (A) the patient's health status, medical care, or treatment 
     options;
       (B) any utilization review requirements that may affect 
     treatment options for the patient; or
       (C) any financial incentives that may affect the treatment 
     of the patient.
       (2) Misrepresentation.--The term ``medical communication'' 
     does not include a communication by a health care provider 
     with a patient of the health care provider (or the guardian 
     or legal representative of such patient) if the communication 
     involves a knowing or willful misrepresentation by such 
     provider.

     SEC. 142. PROHIBITION AGAINST TRANSFER OF INDEMNIFICATION OR 
                   IMPROPER INCENTIVE ARRANGEMENTS.

       (a) Prohibition of Transfer of Indemnification.--
       (1) In general.--No contract or agreement between a group 
     health plan or health insurance issuer (or any agent acting 
     on behalf of such a plan or issuer) and a health care 
     provider shall contain any provision purporting to transfer 
     to the health care provider by indemnification or otherwise 
     any liability relating to activities, actions, or omissions 
     of the plan, issuer, or agent (as opposed to the provider).
       (2) Nullification.--Any contract or agreement provision 
     described in paragraph (1) shall be null and void.
       (b) Prohibition of Improper Physician Incentive Plans.--
       (1) In general.--A group health plan and a health insurance 
     issuer offering health insurance coverage may not operate any 
     physician incentive plan (as defined in subparagraph (B) of 
     section 1876(i)(8) of the Social Security Act) unless the 
     requirements described in subparagraph (A) of such section 
     are met with respect to such a plan.
       (2) Application.--For purposes of carrying out paragraph 
     (1), any reference in section 1876(i)(8) of the Social 
     Security Act to the Secretary, an eligible organization, or 
     an individual enrolled with the organization shall be treated 
     as a reference to the applicable authority, a group health 
     plan or health insurance issuer, respectively, and a 
     participant, beneficiary, or enrollee with the plan or 
     organization, respectively.

     SEC. 143. ADDITIONAL RULES REGARDING PARTICIPATION OF HEALTH 
                   CARE PROFESSIONALS.

       (a) Procedures.--Insofar as a group health plan, or health 
     insurance issuer that offers health insurance coverage, 
     provides benefits through participating health care 
     professionals, the plan or issuer shall establish reasonable 
     procedures relating to the participation (under an agreement 
     between a professional and the plan or issuer) of such 
     professionals under the plan or coverage. Such procedures 
     shall include--
       (1) providing notice of the rules regarding participation;
       (2) providing written notice of participation decisions 
     that are adverse to professionals; and
       (3) providing a process within the plan or issuer for 
     appealing such adverse decisions, including the presentation 
     of information and views of the professional regarding such 
     decision.
       (b) Consultation in Medical Policies.--A group health plan, 
     and health insurance issuer that offers health insurance 
     coverage, shall consult with participating physicians (if 
     any) regarding the plan's or issuer's medical policy, 
     quality, and medical management procedures.

     SEC. 144. PROTECTION FOR PATIENT ADVOCACY.

       (a) Protection for Use of Utilization Review and Grievance 
     Process.--In accordance with section 510 of the Employee 
     Retirement Income Security Act, a group health plan, and a 
     health insurance issuer with respect to the provision of 
     health insurance coverage, may not retaliate against a 
     participant, beneficiary, enrollee, or health care provider 
     based on the participant's, beneficiary's, enrollee's or 
     provider's use of, or participation in, a utilization review 
     process or a grievance process of the plan or issuer 
     (including an internal or external review or appeal process) 
     under this title.

[[Page 15650]]

       (b) Protection for Quality Advocacy by Health Care 
     Professionals.--
       (1) In general.--A group health plan or health insurance 
     issuer may not retaliate or discriminate against a protected 
     health care professional because the professional in good 
     faith--
       (A) discloses information relating to the care, services, 
     or conditions affecting one or more participants, 
     beneficiaries, or enrollees of the plan or issuer to an 
     appropriate public regulatory agency, an appropriate private 
     accreditation body, or appropriate management personnel of 
     the plan or issuer; or
       (B) initiates, cooperates, or otherwise participates in an 
     investigation or proceeding by such an agency with respect to 
     such care, services, or conditions.

     If an institutional health care provider is a participating 
     provider with such a plan or issuer or otherwise receives 
     payments for benefits provided by such a plan or issuer, the 
     provisions of the previous sentence shall apply to the 
     provider in relation to care, services, or conditions 
     affecting one or more patients within an institutional health 
     care provider in the same manner as they apply to the plan or 
     issuer in relation to care, services, or conditions provided 
     to one or more participants, beneficiaries, or enrollees; and 
     for purposes of applying this sentence, any reference to a 
     plan or issuer is deemed a reference to the institutional 
     health care provider.
       (2) Good faith action.--For purposes of paragraph (1), a 
     protected health care professional is considered to be acting 
     in good faith with respect to disclosure of information or 
     participation if, with respect to the information disclosed 
     as part of the action--
       (A) the disclosure is made on the basis of personal 
     knowledge and is consistent with that degree of learning and 
     skill ordinarily possessed by health care professionals with 
     the same licensure or certification and the same experience;
       (B) the professional reasonably believes the information to 
     be true;
       (C) the information evidences either a violation of a law, 
     rule, or regulation, of an applicable accreditation standard, 
     or of a generally recognized professional or clinical 
     standard or that a patient is in imminent hazard of loss of 
     life or serious injury; and
       (D) subject to subparagraphs (B) and (C) of paragraph (3), 
     the professional has followed reasonable internal procedures 
     of the plan, issuer, or institutional health care provider 
     established for the purpose of addressing quality concerns 
     before making the disclosure.
       (3) Exception and special rule.--
       (A) General exception.--Paragraph (1) does not protect 
     disclosures that would violate Federal or State law or 
     diminish or impair the rights of any person to the continued 
     protection of confidentiality of communications provided by 
     such law.
       (B) Notice of internal procedures.--Subparagraph (D) of 
     paragraph (2) shall not apply unless the internal procedures 
     involved are reasonably expected to be known to the health 
     care professional involved. For purposes of this 
     subparagraph, a health care professional is reasonably 
     expected to know of internal procedures if those procedures 
     have been made available to the professional through 
     distribution or posting.
       (C) Internal procedure exception.--Subparagraph (D) of 
     paragraph (2) also shall not apply if--
       (i) the disclosure relates to an imminent hazard of loss of 
     life or serious injury to a patient;
       (ii) the disclosure is made to an appropriate private 
     accreditation body pursuant to disclosure procedures 
     established by the body; or
       (iii) the disclosure is in response to an inquiry made in 
     an investigation or proceeding of an appropriate public 
     regulatory agency and the information disclosed is limited to 
     the scope of the investigation or proceeding.
       (4) Additional considerations.--It shall not be a violation 
     of paragraph (1) to take an adverse action against a 
     protected health care professional if the plan, issuer, or 
     provider taking the adverse action involved demonstrates that 
     it would have taken the same adverse action even in the 
     absence of the activities protected under such paragraph.
       (5) Notice.--A group health plan, health insurance issuer, 
     and institutional health care provider shall post a notice, 
     to be provided or approved by the Secretary of Labor, setting 
     forth excerpts from, or summaries of, the pertinent 
     provisions of this subsection and information pertaining to 
     enforcement of such provisions.
       (6) Constructions.--
       (A) Determinations of coverage.--Nothing in this subsection 
     shall be construed to prohibit a plan or issuer from making a 
     determination not to pay for a particular medical treatment 
     or service or the services of a type of health care 
     professional.
       (B) Enforcement of peer review protocols and internal 
     procedures.--Nothing in this subsection shall be construed to 
     prohibit a plan, issuer, or provider from establishing and 
     enforcing reasonable peer review or utilization review 
     protocols or determining whether a protected health care 
     professional has complied with those protocols or from 
     establishing and enforcing internal procedures for the 
     purpose of addressing quality concerns.
       (C) Relation to other rights.--Nothing in this subsection 
     shall be construed to abridge rights of participants, 
     beneficiaries, enrollees, and protected health care 
     professionals under other applicable Federal or State laws.
       (7) Protected health care professional defined.--For 
     purposes of this subsection, the term ``protected health care 
     professional'' means an individual who is a licensed or 
     certified health care professional and who--
       (A) with respect to a group health plan or health insurance 
     issuer, is an employee of the plan or issuer or has a 
     contract with the plan or issuer for provision of services 
     for which benefits are available under the plan or issuer; or
       (B) with respect to an institutional health care provider, 
     is an employee of the provider or has a contract or other 
     arrangement with the provider respecting the provision of 
     health care services.

     SEC. 145. AMENDMENT TO EMPLOYEE RETIREMENT INCOME SECURITY 
                   ACT OF 1974.

       (a) In General.--Notwithstanding section 301(b), section 
     503 of the Employee Retirement Income Security Act of 1974 
     (29 U.S.C. 1133) is amended to read as follows:

     ``SEC. 503. CLAIMS PROCEDURE, COVERAGE DETERMINATION, 
                   GRIEVANCES AND APPEALS.

       ``(a) Claims Procedure.--In accordance with regulations of 
     the Secretary, every employee benefit plan shall--
       ``(1) provide adequate notice in writing to any participant 
     or beneficiary whose claim for benefits under the plan has 
     been denied, setting forth the specific reasons for such 
     denial, written in a manner calculated to be understood by 
     the participant; and
       ``(2) afford a reasonable opportunity to any participant 
     whose claim for benefits has been denied for a full and fair 
     review by the appropriate named fiduciary of the decision 
     denying the claim.
       ``(b) Coverage Determinations Under Group Health Plans.--
       ``(1) Procedures.--
       ``(A) In general.--A group health plan or health insurance 
     issuer conducting utilization review shall ensure that 
     procedures are in place for--
       ``(i) making determinations regarding whether a participant 
     or beneficiary is eligible to receive a payment or coverage 
     for health services under the plan or coverage involved and 
     any cost-sharing amount that the participant or beneficiary 
     is required to pay with respect to such service;
       ``(ii) notifying a covered participant or beneficiary (or 
     the authorized representative of such participant or 
     beneficiary) and the treating health care professionals 
     involved regarding determinations made under the plan or 
     issuer and any additional payments that the participant or 
     beneficiary may be required to make with respect to such 
     service; and
       ``(iii) responding to requests, either written or oral, for 
     coverage determinations or for internal appeals from a 
     participant or beneficiary (or the authorized representative 
     of such participant or beneficiary) or the treating health 
     care professional with the consent of the participant or 
     beneficiary.
       ``(B) Oral requests.--With respect to an oral request 
     described in subparagraph (A)(iii), a group health plan or 
     health insurance issuer may require that the requesting 
     individual provide written evidence of such request.
       ``(2) Timeline for making determinations.--
       ``(A) Routine determination.--A group health plan or a 
     health insurance issuer shall maintain procedures to ensure 
     that prior authorization determinations concerning the 
     provision of non-emergency items or services are made within 
     30 days from the date on which the request for a 
     determination is submitted, except that such period may be 
     extended where certain circumstances exist that are 
     determined by the Secretary to be beyond control of the plan 
     or issuer.
       ``(B) Expedited determination.--
       ``(i) In general.--A prior authorization determination 
     under this subsection shall be made within 72 hours, in 
     accordance with the medical exigencies of the case, after a 
     request is received by the plan or issuer under clause (ii) 
     or (iii).
       ``(ii) Request by participant or beneficiary.--A plan or 
     issuer shall maintain procedures for expediting a prior 
     authorization determination under this subsection upon the 
     request of a participant or beneficiary if, based on such a 
     request, the plan or issuer determines that the normal time 
     for making such a determination could seriously jeopardize 
     the life or health of the participant or beneficiary.
       ``(iii) Documentation by health care professional.--A plan 
     or issuer shall maintain procedures for expediting a prior 
     authorization determination under this subsection if the 
     request involved indicates that the treating health care 
     professional has reasonably documented, based on the medical 
     exigencies, that a determination under the procedures 
     described in subparagraph (A) could seriously jeopardize the 
     life or health of the participant or beneficiary.

[[Page 15651]]

       ``(C) Concurrent determinations.--A plan or issuer shall 
     maintain procedures to certify or deny coverage of an 
     extended stay or additional services.
       ``(D) Retrospective determination.--A plan or issuer shall 
     maintain procedures to ensure that, with respect to the 
     retrospective review of a determination made under paragraph 
     (1), the determination shall be made within 30 working days 
     of the date on which the plan or issuer receives necessary 
     information.
       ``(3) Notice of determinations.--
       ``(A) Routine determination.--With respect to a coverage 
     determination of a plan or issuer under paragraph (2)(A), the 
     plan or issuer shall issue notice of such determination to 
     the participant or beneficiary (or the authorized 
     representative of the participant or beneficiary) and, 
     consistent with the medical exigencies of the case, to the 
     treating health care professional involved not later than 2 
     working days after the date on which the determination is 
     made.
       ``(B) Expedited determination.--With respect to a coverage 
     determination of a plan or issuer under paragraph (2)(B), the 
     plan or issuer shall issue notice of such determination to 
     the participant or beneficiary (or the authorized 
     representative of the participant or beneficiary), and 
     consistent with the medical exigencies of the case, to the 
     treating health care professional involved within the 72 hour 
     period described in paragraph (2)(B).
       ``(C) Concurrent reviews.--With respect to the 
     determination under a plan or issuer under paragraph (2)(C) 
     to certify or deny coverage of an extended stay or additional 
     services, the plan or issuer shall issue notice of such 
     determination to the treating health care professional and to 
     the participant or beneficiary involved (or the authorized 
     representative of the participant or beneficiary) within 1 
     working day of the determination.
       ``(D) Retrospective reviews.--With respect to the 
     retrospective review under a plan or issuer of a 
     determination made under paragraph (2)(D), the plan or issuer 
     shall issue written notice of an approval or disapproval of a 
     determination under this subparagraph to the participant or 
     beneficiary (or the authorized representative of the 
     participant or beneficiary) and health care provider involved 
     within 5 working days of the date on which such determination 
     is made.
       ``(E) Requirements of notice of adverse coverage 
     determinations.--A written notice of an adverse coverage 
     determination under this subsection, or of an expedited 
     adverse coverage determination under paragraph (2)(B), shall 
     be provided to the participant or beneficiary (or the 
     authorized representative of the participant or beneficiary) 
     and treating health care professional (if any) involved and 
     shall include--
       ``(i) the reasons for the determination (including the 
     clinical or scientific-evidence based rationale used in 
     making the determination) written in a manner to be 
     understandable to the average participant or beneficiary;
       ``(ii) the procedures for obtaining additional information 
     concerning the determination; and
       ``(iii) notification of the right to appeal the 
     determination and instructions on how to initiate an appeal 
     in accordance with subsection (d).
       ``(c) Grievances.--A group health plan or a health 
     insurance issuer shall have written procedures for addressing 
     grievances between the plan or issuer offering health 
     insurance coverage in connection with a group health plan and 
     a participant or beneficiary. Determinations under such 
     procedures shall be non-appealable.
       ``(d) Internal Appeal of Coverage Determinations.--
       ``(1) Right to appeal.--
       ``(A) In general.--A participant or beneficiary (or the 
     authorized representative of the participant or beneficiary) 
     or the treating health care professional with the consent of 
     the participant or beneficiary (or the authorized 
     representative of the participant or beneficiary), may appeal 
     any adverse coverage determination under subsection (b) under 
     the procedures described in this subsection.
       ``(B) Time for appeal.--A plan or issuer shall ensure that 
     a participant or beneficiary has a period of not less than 
     180 days beginning on the date of an adverse coverage 
     determination under subsection (b) in which to appeal such 
     determination under this subsection.
       ``(C) Failure to act.--The failure of a plan or issuer to 
     issue a determination under subsection (b) within the 
     applicable timeline established for such a determination 
     under such subsection shall be treated as an adverse coverage 
     determination for purposes of proceeding to internal review 
     under this subsection.
       ``(2) Records.--A group health plan and a health insurance 
     issuer shall maintain written records, for at least 6 years, 
     with respect to any appeal under this subsection for purposes 
     of internal quality assurance and improvement. Nothing in the 
     preceding sentence shall be construed as preventing a plan 
     and issuer from entering into an agreement under which the 
     issuer agrees to assume responsibility for compliance with 
     the requirements of this section and the plan is released 
     from liability for such compliance.
       ``(3) Routine determinations.--A group health plan or a 
     health insurance issuer shall complete the consideration of 
     an appeal of an adverse routine determination under this 
     subsection not later than 30 working days after the date on 
     which a request for such appeal is received.
       ``(4) Expedited determination.--
       ``(A) In general.--An expedited determination with respect 
     to an appeal under this subsection shall be made in 
     accordance with the medical exigencies of the case, but in no 
     case more than 72 hours after the request for such appeal is 
     received by the plan or issuer under subparagraph (B) or (C).
       ``(B) Request by participant or beneficiary.--A plan or 
     issuer shall maintain procedures for expediting a prior 
     authorization determination under this subsection upon the 
     request of a participant or beneficiary if, based on such a 
     request, the plan or issuer determines that the normal time 
     for making such a determination could seriously jeopardize 
     the life or health of the participant or beneficiary.
       ``(C) Documentation by health care professional.--A plan or 
     issuer shall maintain procedures for expediting a prior 
     authorization determination under this subsection if the 
     request involved indicates that the treating health care 
     professional has reasonably documented, based on the medical 
     exigencies of the case that a determination under the 
     procedures described in paragraph (2) could seriously 
     jeopardize the life or health of the participant or 
     beneficiary.
       ``(5) Conduct of review.--A review of an adverse coverage 
     determination under this subsection shall be conducted by an 
     individual with appropriate expertise who was not directly 
     involved in the initial determination.
       ``(6) Lack of medical necessity.--A review of an appeal 
     under this subsection relating to a determination to deny 
     coverage based on a lack of medical necessity and 
     appropriateness, or based on an experimental or 
     investigational treatment, shall be made only by a physician 
     with appropriate expertise, including age-appropriate 
     expertise, who was not involved in the initial determination.
       ``(7) Notice.--
       ``(A) In general.--Written notice of a determination made 
     under an internal review process shall be issued to the 
     participant or beneficiary (or the authorized representative 
     of the participant or beneficiary) and the treating health 
     care professional not later than 2 working days after the 
     completion of the review (or within the 72-hour period 
     referred to in paragraph (4) if applicable).
       ``(B) Adverse coverage determinations.--With respect to an 
     adverse coverage determination made under this subsection, 
     the notice described in subparagraph (A) shall include--
       ``(i) the reasons for the determination (including the 
     clinical or scientific-evidence based rationale used in 
     making the determination) written in a manner to be 
     understandable to the average participant or beneficiary;
       ``(ii) the procedures for obtaining additional information 
     concerning the determination; and
       ``(iii) notification of the right to an independent 
     external review under subsection (e) and instructions on how 
     to initiate such a review.
       ``(e) Independent External Review.--
       ``(1) Access to review.--
       ``(A) In general.--A group health plan or a health 
     insurance issuer offering health insurance coverage in 
     connection with a group health plan shall have written 
     procedures to permit a participant or beneficiary (or the 
     authorized representative of the participant or beneficiary) 
     access to an independent external review with respect to an 
     adverse coverage determination concerning a particular item 
     or service (including a circumstance treated as an adverse 
     coverage determination under subparagraph (B)) where--
       ``(i) the particular item or service involved--

       ``(I)(aa) would be a covered benefit, when medically 
     necessary and appropriate under the terms and conditions of 
     the plan, and the item or service has been determined not to 
     be medically necessary and appropriate under the internal 
     appeals process required under subsection (d) or there has 
     been a failure to issue a coverage determination as described 
     in subparagraph (B); and
       ``(bb)(AA) the amount of such item or service involved 
     exceeds a significant financial threshold; or
       ``(BB) there is a significant risk of placing the life or 
     health of the participant or beneficiary in jeopardy; or
       ``(II) would be a covered benefit, when not considered 
     experimental or investigational under the terms and 
     conditions of the plan, and the item or service has been 
     determined to be experimental or investigational under the 
     internal appeals process required under subsection (d) or 
     there has been a failure to issue a coverage determination as 
     described in subparagraph (B); and

       ``(ii) the participant or beneficiary has completed the 
     internal appeals process under subsection (d) with respect to 
     such determination.
       ``(B) Failure to act.--The failure of a plan or issuer to 
     issue a coverage determination

[[Page 15652]]

     under subsection (d)(6) within the applicable timeline 
     established for such a determination under such subsection 
     shall be treated as an adverse coverage determination for 
     purposes of proceeding to independent external review under 
     this subsection.
       ``(2) Initiation of the independent external review 
     process.--
       ``(A) Filing of request.--A participant or beneficiary (or 
     the authorized representative of the participant or 
     beneficiary) who desires to have an independent external 
     review conducted under this subsection shall file a written 
     request for such a review with the plan or issuer involved 
     not later than 30 working days after the receipt of a final 
     denial of a claim under subsection (d). Any such request 
     shall include the consent of the participant or beneficiary 
     (or the authorized representative of the participant or 
     beneficiary) for the release of medical information and 
     records to independent external reviewers regarding the 
     participant or beneficiary.
       ``(B) Information and notice.--Not later than 5 working 
     days after the receipt of a request under subparagraph (A), 
     or earlier in accordance with the medical exigencies of the 
     case, the plan or issuer involved shall select an external 
     appeals entity under paragraph (3)(A) that shall be 
     responsible for designating an independent external reviewer 
     under paragraph (3)(B).
       ``(C) Provision of information.--The plan or issuer 
     involved shall forward necessary information (including 
     medical records, any relevant review criteria, the clinical 
     rationale consistent with the terms and conditions of the 
     contract between the plan or issuer and the participant or 
     beneficiary for the coverage denial, and evidence of the 
     coverage of the participant or beneficiary) to the 
     independent external reviewer selected under paragraph 
     (3)(B).
       ``(D) Notification.--The plan or issuer involved shall send 
     a written notification to the participant or beneficiary (or 
     the authorized representative of the participant or 
     beneficiary) and the plan administrator, indicating that an 
     independent external review has been initiated.
       ``(3) Conduct of independent external review.--
       ``(A) Designation of external appeals entity by plan or 
     issuer.--
       ``(i) In general.--A plan or issuer that receives a request 
     for an independent external review under paragraph (2)(A) 
     shall designate a qualified entity described in clause (ii), 
     in a manner designed to ensure that the entity so designated 
     will make a decision in an unbiased manner, to serve as the 
     external appeals entity.
       ``(ii) Qualified entities.--A qualified entity shall be--

       ``(I) an independent external review entity licensed or 
     credentialed by a State;
       ``(II) a State agency established for the purpose of 
     conducting independent external reviews;
       ``(III) any entity under contract with the Federal 
     Government to provide independent external review services;
       ``(IV) any entity accredited as an independent external 
     review entity by an accrediting body recognized by the 
     Secretary for such purpose; or
       ``(V) any other entity meeting criteria established by the 
     Secretary for purposes of this subparagraph.

       ``(B) Designation of independent external reviewer by 
     external appeals entity.--The external appeals entity 
     designated under subparagraph (A) shall, not later than 30 
     days after the date on which such entity is designated under 
     subparagraph (A), or earlier in accordance with the medical 
     exigencies of the case, designate one or more individuals to 
     serve as independent external reviewers with respect to a 
     request received under paragraph (2)(A). Such reviewers shall 
     be independent medical experts who shall--
       ``(i) be appropriately credentialed or licensed in any 
     State to deliver health care services;
       ``(ii) not have any material, professional, familial, or 
     financial affiliation with the case under review, the 
     participant or beneficiary involved, the treating health care 
     professional, the institution where the treatment would take 
     place, or the manufacturer of any drug, device, procedure, or 
     other therapy proposed for the participant or beneficiary 
     whose treatment is under review;
       ``(iii) have expertise (including age-appropriate 
     expertise) in the diagnosis or treatment under review and, 
     when reasonably available, be of the same specialty as the 
     physician treating the participant or beneficiary or 
     recommending or prescribing the treatment in question;
       ``(iv) receive only reasonable and customary compensation 
     from the group health plan or health insurance issuer in 
     connection with the independent external review that is not 
     contingent on the decision rendered by the reviewer; and
       ``(v) not be held liable for decisions regarding medical 
     determinations (but may be held liable for actions that are 
     arbitrary and capricious).
       ``(4) Standard of review.--
       ``(A) In general.--An independent external reviewer shall--
       ``(i) make an independent determination based on the valid, 
     relevant, scientific and clinical evidence to determine the 
     medical necessity, appropriateness, experimental or 
     investigational nature of the proposed treatment; and
       ``(ii) take into consideration appropriate and available 
     information, including any evidence-based decision making or 
     clinical practice guidelines used by the group health plan or 
     health insurance issuer; timely evidence or information 
     submitted by the plan, issuer, patient or patient's 
     physician; the patient's medical record; expert consensus; 
     and medical literature as defined in section 556(5) of the 
     Federal Food, Drug, and Cosmetic Act.
       ``(B) Notice.--The plan or issuer involved shall ensure 
     that the participant or beneficiary receives notice, within 
     30 days after the determination of the independent medical 
     expert, regarding the actions of the plan or issuer with 
     respect to the determination of such expert under the 
     independent external review.
       ``(5) Timeframe for review.--
       ``(A) In general.--The independent external reviewer shall 
     complete a review of an adverse coverage determination in 
     accordance with the medical exigencies of the case.
       ``(B) Limitation.--Notwithstanding subparagraph (A), a 
     review described in such subparagraph shall be completed not 
     later than 30 working days after the later of--
       ``(i) the date on which such reviewer is designated; or
       ``(ii) the date on which all information necessary to 
     completing such review is received.
       ``(6) Binding determination.--The determination of an 
     independent external reviewer under this subsection shall be 
     binding upon the plan or issuer if the provisions of this 
     subsection or the procedures implemented under such 
     provisions were complied with by the independent external 
     reviewer.
       ``(7) Study.--Not later than 2 years after the date of 
     enactment of this section, the General Accounting Office 
     shall conduct a study of a statistically appropriate sample 
     of completed independent external reviews. Such study shall 
     include an assessment of the process involved during an 
     independent external review and the basis of decisionmaking 
     by the independent external reviewer. The results of such 
     study shall be submitted to the appropriate committees of 
     Congress.
       ``(8) Effect on certain provisions.--Nothing in this 
     section shall be construed as affecting or modifying section 
     514 of this Act with respect to a group health plan.
       ``(f) Rule of Construction.--Nothing in this section shall 
     be construed to prohibit a plan administrator or plan 
     fiduciary or health plan medical director from requesting an 
     independent external review by an independent external 
     reviewer without first completing the internal review 
     process.
       ``(g) Definitions.--In this section:
       ``(1) Adverse coverage determination.--The term `adverse 
     coverage determination' means a coverage determination under 
     the plan which results in a denial of coverage or 
     reimbursement.
       ``(2) Coverage determination.--The term `coverage 
     determination' means with respect to items and services for 
     which coverage may be provided under a health plan, a 
     determination of whether or not such items and services are 
     covered or reimbursable under the coverage and terms of the 
     contract.
       ``(3) Grievance.--The term `grievance' means any complaint 
     made by a participant or beneficiary that does not involve a 
     coverage determination.
       ``(4) 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.
       ``(5) 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.
       ``(6) Health insurance issuer.--The term `health insurance 
     issuer' has the meaning given such term in section 733(b)(2).
       ``(7) Prior authorization determination.--The term `prior 
     authorization determination' means a coverage determination 
     prior to the provision of the items and services as a 
     condition of coverage of the items and services under the 
     coverage.
       ``(8) 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.
       ``(9) Utilization review.--The term `utilization review' 
     with respect to a group health plan or health insurance 
     coverage means a set of formal techniques designed to monitor 
     the use of, or evaluate the clinical necessity, 
     appropriateness, efficacy, or efficiency of, health care 
     services, procedures, or settings. Techniques may include 
     ambulatory review,

[[Page 15653]]

     prospective review, second opinion, certification, concurrent 
     review, case management, discharge planning or retrospective 
     review.''
       (b) Enforcement.--Section 502(c)(1) of the Employee 
     Retirement Income Security Act of 1974 (29 U.S.C. 1132(c)(1)) 
     is amended by inserting after ``or section 101(e)(1)'' the 
     following: ``, or fails to comply with a coverage 
     determination as required under section 503(e)(6),''.
       (c) Conforming Amendment.--The table of contents in section 
     1 of the Employee Retirement Income Security Act of 1974 is 
     amended by striking the item relating to section 503 and 
     inserting the following new item:

``Sec. 503. Claims procedures, coverage determination, grievances and 
              appeals.''.

       (d) Effective Date.--The amendments made by this section 
     shall apply with respect to plan years beginning on or after 
     October 1, 2000. The Secretary shall issue all regulations 
     necessary to carry out the amendments made by this section 
     before the effective date thereof.
                                 ______
                                 

                  DODD (AND OTHERS) AMENDMENT NO. 1239

  Mr. DODD (for himself, Mrs. Boxer, Mr. Harkin, Mr. Kennedy, Mr. Reid, 
Mrs. Murray, Mr. Durbin, Mr. Rockefeller, Mr. Feingold, Mrs. Feinstein, 
and Mr. Daschle) proposed an amendment to amendment No. 1232 proposed 
by Mr. Daschle to the bill, S. 1344, supra; as follows:

       At the appropriate place in subtitle A of title I, insert 
     the following:

     SEC. __. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED 
                   CLINICAL TRIALS AND ACCESS TO APPROVED DRUGS 
                   AND DEVICES.

       (a) ERISA.--Subpart C of part 7 of subtitle B of title I of 
     the Employee Retirement Income Security Act of 1974, as added 
     by section 101(a)(2) of this Act, is amended by adding at the 
     end the following:

     ``SEC. 730A. COVERAGE FOR INDIVIDUALS PARTICIPATING IN 
                   APPROVED CLINICAL TRIALS AND ACCESS TO APPROVED 
                   DRUGS AND DEVICES.

       ``(a) Coverage for Individuals Participating in Approved 
     Clinical Trials.--
       ``(1) Coverage.--
       ``(A) In general.--If a group health plan, or a health 
     insurance issuer in connection with group health insurance 
     coverage, provides coverage to a qualified individual (as 
     defined in paragraph (2)), the plan or issuer--
       ``(i) may not deny the individual participation in the 
     clinical trial referred to in paragraph (2)(B);
       ``(ii) subject to paragraph (3), 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 participant's, beneficiaries or enrollee's 
     participation 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 or issuer 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 or enrollee under health insurance coverage and 
     who meets the following conditions:
       ``(A)(i) The individual has a life-threatening or serious 
     illness for which no standard treatment is effective.
       ``(ii) The individual is eligible to participate in an 
     approved clinical trial according to the trial protocol with 
     respect to treatment of such illness.
       ``(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 
     the individual meeting the conditions described in 
     subparagraph (A); or
       ``(ii) the participant, beneficiary or enrollee 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 
     subparagraph (A).
       ``(3) Payment.--
       ``(A) In general.--Under this subsection a group health 
     plan, or a health insurance issuer in connection with group 
     health insurance coverage, 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 (as determined by the Secretary) to be 
     paid for by the sponsors of an approved clinical trial.
       ``(B) Payment rate.--In the case of covered items and 
     services provided by--
       ``(i) a participating provider, the payment rate shall be 
     at the agreed upon rate, or
       ``(ii) a nonparticipating provider, the payment rate shall 
     be at the rate the plan or issuer would normally pay for 
     comparable services under clause (i).
       ``(4) Approved clinical trial defined.--
       ``(A) In general.--In this subsection, the term `approved 
     clinical trial' means a clinical research study or clinical 
     investigation approved and funded (which may include funding 
     through in-kind contributions) by one or more of the 
     following:
       ``(i) The National Institutes of Health.
       ``(ii) A cooperative group or center of the National 
     Institutes of Health.
       ``(iii) Either of the following if the conditions described 
     in subparagraph (B) are met:

       ``(I) The Department of Veterans Affairs.
       ``(II) The Department of Defense.

       ``(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 section shall be 
     construed to limit a plan's or issuer's coverage with respect 
     to clinical trials.
       ``(b) Access to Needed Prescription Drugs.--If a group 
     health plan, or health insurance issuer that offers group 
     health insurance coverage, provides benefits with respect to 
     prescription drugs but the coverage limits such benefits to 
     drugs included in a formulary, the plan or issuer shall--
       ``(1) ensure participation of participating physicians and 
     pharmacists in the development of the formulary;
       ``(2) disclose to providers and, disclose upon request to 
     participants, beneficiaries, and enrollees, the nature of the 
     formulary restrictions; and
       ``(3) consistent with the standards for a utilization 
     review program, provide for exceptions from the formulary 
     limitation when a non-formulary alternative is medically 
     indicated, except that--
       ``(A) an exception provided under this paragraph shall be 
     provided in accordance with cost-sharing rules in effect for 
     drugs included in the formulary; and
       ``(B) nothing in this paragraph shall be construed to 
     prevent the plan or issuer from implementing a program of 
     differential cost-sharing for drugs included in the formulary 
     and drugs not included in the formulary, if the drugs that 
     are not included in the formulary do not meet the conditions 
     described in this section.
       ``(c) Access to Approved Drugs and Devices.--
       ``(1) In general.--A group health plan, or a health 
     insurance issuer in connection with group health insurance 
     coverage, that provides any coverage of prescription drugs or 
     medical devices shall not deny coverage of such a drug or 
     device on the basis that the use is investigational, if the 
     use--
       ``(A) in the case of a prescription drug--
       ``(i) is included in the labeling authorized by the 
     application in effect for the drug pursuant to subsection (b) 
     or (j) of section 505 of the Federal Food, Drug, and Cosmetic 
     Act, without regard to any postmarketing requirements that 
     may apply under such Act; or
       ``(ii) is included in the labeling authorized by the 
     application in effect for the drug under section 351 of the 
     Public Health Service Act, without regard to any 
     postmarketing requirements that may apply pursuant to such 
     section; or
       ``(B) in the case of a medical device, is included in the 
     labeling authorized by a regulation under subsection (d) or 
     (3) of section 513 of the Federal Food, Drug, and Cosmetic 
     Act, an order under subsection (f) of such section, or an 
     application approved under section 515 of such Act, without 
     regard to any postmarketing requirements that may apply under 
     such Act.
       ``(2) Construction.--Nothing in this subsection shall be 
     construed as requiring a group health plan or health 
     insurance issuer to provide any coverage of prescription 
     drugs or medical devices.
       ``(d) Application of Section.--This section shall supersede 
     the provisions of section 728.
       ``(e) Review.--Failure to meet the requirements of this 
     section shall constitute an appealable decision under this 
     Act.
       ``(f) Plan Satisfaction of Certain Requirements.--Pursuant 
     to rules of the Secretary, if a health insurance issuer 
     offers health insurance coverage in connection with a group 
     health plan and takes an action in violation of any provision 
     of this subchapter, the group health plan shall not be liable 
     for such violation unless the plan caused such violation.
       ``(g) Applicability.--The provisions of this section shall 
     apply to group health plans and health insurance issuers as 
     if included in--

[[Page 15654]]

       ``(1) subpart 2 of part A of title XXVII of the Public 
     Health Service Act;
       ``(2) the first subpart 3 of part B of title XXVII of the 
     Public Health Service Act (relating to other requirements); 
     and
       ``(3) subchapter B of chapter 100 of the Internal Revenue 
     Code of 1986.
       ``(h) Nonapplication of Certain Provision.--Only for 
     purposes of applying the requirements of this section under 
     section 714 of the Employee Retirement Income Security Act of 
     1974 (as added by section 301 of this Act), sections 2707 and 
     2753 of the Public Health Service Act (as added by sections 
     201 and 202 of this Act), and section 9813 of the Internal 
     Revenue Code of 1986 (as added by section 401 of this Act)--
       ``(1) section 2721(b)(2) of the Public Health Service Act 
     and section 9831(a)(1) of the Internal Revenue Code of 1986 
     shall not apply to the provisions of this section; and
       ``(2) with respect to limited scope dental benefits, 
     subparagraph (A) of section 733(c)(2) of the Employee 
     Retirement Income Security Act of 1974, subparagraph (A) of 
     section 2791(c)(2) of the Public Health Service Act, and 
     subparagraph (A) of section 9832(c)(2) of the Internal 
     Revenue Code of 1986 shall not apply to the provisions of 
     this section.
       ``(i) No Impact on Social Security Trust Fund.--
       ``(1) In general.--Nothing in this section 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 
     section 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 section 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 section.
       ``(j) Limitation on actions.--
       ``(1) In general.--Except as provided for in paragraph (2), 
     no action may be brought under subsection (a)(1)(B), (a)(2), 
     or (a)(3) of section 502 by a participant or beneficiary 
     seeking relief based on the application of any provision in 
     this section.
       ``(2) Permissible actions.--An action may be brought under 
     subsection (a)(1)(B), (a)(2), or (a)(3) of section 502 by a 
     participant or beneficiary seeking relief based on the 
     application of this section to the individual circumstances 
     of that participant or beneficiary; except that--
       ``(A) such an action may not be brought or maintained as a 
     class action; and
       ``(B) in such an action relief may only provide for the 
     provision of (or payment for) benefits, items, or services 
     denied to the individual participant or beneficiary involved 
     (and for attorney's fees and the costs of the action, at the 
     discretion of the court) and shall not provide for any other 
     relief to the participant or beneficiary or for any relief to 
     any other person.
       ``(3) Rule of construction.--Nothing in this subsection 
     shall be construed as affecting any action brought by the 
     Secretary.
       ``(k) Effective Date.--The provisions of this section shall 
     apply to group health plans for plan years beginning after, 
     and to health insurance issuers for coverage offered or sold 
     after, October 1, 2000.''.
       (b) 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.
       (c) Modification to Foreign Tax Credit Carryback and 
     Carryover Periods.--
       (1) In general.--Section 904(c) of the Internal Revenue 
     Code of 1986 (relating to limitation on credit) is amended--
       (A) by striking ``in the second preceding taxable year,'', 
     and
       (B) by striking ``or fifth'' and inserting ``fifth, sixth, 
     or seventh''.
       (2) Effective date.--The amendment made by paragraph (1) 
     shall apply to credits arising in taxable years beginning 
     after December 31, 2001.
       (d) Limitations on Welfare Benefit Funds of 10 or More 
     Employer Plans.--
       (1) Benefits to which exception applies.--Section 
     419A(f)(6)(A) of the Internal Revenue Code of 1986 (relating 
     to exception for 10 or more employer plans) is amended to 
     read as follows:
       ``(A) In general.--This subpart shall not apply to a 
     welfare benefit fund which is part of a 10 or more employer 
     plan if the only benefits provided through the fund are 1 or 
     more of the following:
       ``(i) Medical benefits.
       ``(ii) Disability benefits.
       ``(iii) Group term life insurance benefits which do not 
     provide for any cash surrender value or other money that can 
     be paid, assigned, borrowed, or pledged for collateral for a 
     loan.

     The preceding sentence shall not apply to any plan which 
     maintains experience-rating arrangements with respect to 
     individual employers.''
       (2) Limitation on use of amounts for other purposes.--
     Section 4976(b) of such Act (defining disqualified benefit) 
     is amended by adding at the end the following new paragraph:
       ``(5) Special rule for 10 or more employer plans exempted 
     from prefunding limits.--For purposes of paragraph (1)(C), 
     if--
       ``(A) subpart D of part I of subchapter D of chapter 1 does 
     not apply by reason of section 419A(f)(6) to contributions to 
     provide 1 or more welfare benefits through a welfare benefit 
     fund under a 10 or more employer plan, and
       ``(B) any portion of the welfare benefit fund attributable 
     to such contributions is used for a purpose other than that 
     for which the contributions were made,

     then such portion shall be treated as reverting to the 
     benefit of the employers maintaining the fund.''
       (3) Effective date.--The amendments made by this subsection 
     shall apply to contributions paid or accrued after the date 
     of the enactment of this Act, in taxable years ending after 
     such date.

[[Page 15655]]



                          ____________________