[Congressional Record Volume 144, Number 96 (Friday, July 17, 1998)]
[Senate]
[Pages S8487-S8511]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. LOTT (for Mr. Nickles, for himself, Mr. Frist, Ms. 
        Collins, Mr. Jeffords, Mr. Roth, Mr. Santorum, Mr. Hagel, Mr. 
        Gramm, Mr. Coats, Mr. Lott, Mr. Mack, Mr. Craig, Mr. Coverdell, 
        Mr. Abraham, Mr. Allard, Mr. Ashcroft, Mr. Bennett, Mr. Bond, 
        Mr. Brownback, Mr. Burns, Mr. Cochran, Mr. Domenici, Mr. Enzi, 
        Mr. Faircloth, Mr. Gorton, Mr. Grams, Mr. Grassley, Mr. Hatch, 
        Mr. Helms, Mr. Hutchinson, Mrs. Hutchison, Mr. Inhofe, Mr. 
        Kempthorne, Mr. Lugar, Mr. McCain, Mr. Murkowski, Mr. Roberts, 
        Mr. Sessions, Mr. Shelby, Mr. Smith of New Hampshire, Mr. Smith 
        of Oregon, Ms. Snowe, Mr. Thomas, Mr. Thompson, Mr. Thurmond, 
        and Mr. Warner):
  S. 2330. A bill to improve the access and choice of patients to 
quality, affordable health care; read the first time.


                        PATIENTS' BILL OF RIGHTS

  Mr. NICKLES. Mr. President, today I am introducing the Republican 
Patients' Bill of Rights. Joining me in this effort are 46 of my 
colleagues who recognize the importance of ensuring that all Americans 
are able to not only receive the care they have been promised, but also 
receive the highest quality of care available. The foundation of this 
proposal was to address some of the very real concerns that consumers 
have about their health care needs.
  We know that many Americans have believed they were denied coverage 
that their plans were supposed to cover. We recognize that some 
individuals fear that their health care plans will not give them access 
to specialists when they need them. We know that some Americans think 
their health care plans care more about cost than they do about 
quality.
  In contrast, we also know that many Americans are happy and satisfied 
with their health care plan. We know that 81 percent of managed care 
enrollees are satisfied with their current health care plan. Another 
recent analysis suggest that 79 percent of consumers in HMOs would 
recommend their coverage. In addition Americans are leery of Washington 
solutions and increased federal intervention.
  Last January, the Leader asked me to put together a group of 
colleagues to address the issue of health care quality. For the past 
seven months, Senators Frist, Collins, Hagel, Roth, Jeffords, Coats, 
Santorum, and Gramm worked tirelessly to put together a responsible, 
credible package that would preserve what is best about our Nation's 
health care while at the same time determine ways to improve upon--
without stifling--the quality of care our nation delivers. We set out 
to rationally examine the issues and develop reasonable solutions 
without injuring patient access to affordable, high quality care.
  This was no easy task. We spent month after month talking to experts 
who understand the difficulty and complexity of our system. We met with 
representatives from all aspects of the industry including the Mayo 
Clinic, the Henry Ford Health Systems, the American Medical 
Association, the American Hospital Association, the National Committee 
for Quality Assurance, the Joint Commission on the Accreditation of 
Healthcare Organizations, Corporate Medical Directors, Commissioners 
from the President's Quality Commission, Purchasers, Families USA, the 
Employee Benefit Research Institute and many others.
  After many, many months of dissecting serious questions about our 
system we determined that there were indeed some areas in which we 
could improve patient access and quality.
  We have put together an innovative plan that will answer the problems 
that exist in the industry while at the same time preserving 
affordability, which is of utmost importance. Mr. President, I think 
you agree that if someone loses their health insurance because a 
politician playing doctor drives prices to an unaffordable level, you 
have hardly given them more rights or better quality health care.
  We are proud of what we have been able to accomplish. For the first 
time, patients can choose to be unencumbered in their relationship with 
their doctor. They will be able to choose their own doctor and get the 
middle man out of the way. There will be no corporate bureaucrat, no 
government bureaucrat and no lawyer standing between a patient and 
their doctor.
  Mr. President, the bill we introduce today:
  Protects consumers in employer-sponsored plans that are exempt from 
state regulation. People enrolled in such plans will have the right to:
  Choose their doctors. Our bill contains both ``point-of-service'' and 
``continuity of care'' requirements that will enhance consumer choice.
  See their ob-gyns and pediatricians without referral. Our bill will 
give patients direct access to pediatricians and ob-gyns without prior 
referral from a ``gatekeeper.''
  Have a ``prudent layperson'' standard applied to their claims for 
emergency care. The GOP alternative will require health plans to 
cover--without prior authorization--emergency care that a ``prudent 
layperson'' would consider medically necessary.
  Communicate openly with their doctors without ``gag'' clauses.
  Holds health plans accountable for their decisions.
  Extends to enrollees in ERISA health plans and their doctors the 
right to appeal adverse coverage decisions to a physician who was not 
involved in the initial coverage determination.
  Allows enrollees to appeal adverse coverage determinations to 
independent medical experts who have no affiliation with the health 
plan. Determinations by these experts will be binding on the health 
plan.
  Requires health plans to disclose to enrollees consumer information, 
including what's covered, what's not,

[[Page S8488]]

how much they'll have to pay in deductibles and coinsurance, and how to 
appeal adverse coverage decisions to independent medical experts.
  Guarantees consumers access to their medical records.
  Requires health care providers, health plans, employers, health and 
life insurers, and schools and universities to permit an individual to 
inspect, copy and amend his or her own medical information.
  Requires health care providers, health plans, health oversight 
agencies, public health authorities, employers, health and life 
insurers, health researchers, law enforcement officials, and schools 
and universities to establish appropriate safeguards to protect the 
confidentiality, security, accuracy and integrity of protected health 
information and notify enrollees of these safeguards.

  Protects patients from genetic discrimination in health insurance. 
Prohibits health plans from collecting or using predictive genetic 
information about a patient to deny health insurance coverage or set 
premium rates.
  Promotes quality improvement by supporting research to give patients 
and physicians better information regarding quality.
  Establishes the Agency for Healthcare Quality Research (AHQR), whose 
purpose is to foster overall improvement in healthcare quality and 
bridge the gap between what we know and what we do in healthcare today. 
The Agency is built on the platform of the current Agency for Health 
Care Policy and Research, but is refocused and enhanced to become the 
hub and driving force of federal efforts to improve the quality of 
healthcare in all practice environments--not just managed care.
  The role of the Agency is not to mandate a national definition of 
quality, but to support the science necessary to provide information to 
patients regarding the quality of the care they receive, to allow 
physicians to compare their quality outcomes with their peers, and to 
enable employers and individuals to be prudent purchasers based on 
quality.
  Supports research, screening, treatment, education, and data 
collection activities to improve the health of women.
  Promotes basic and clinical research for osteoporosis; breast and 
ovarian cancer; and aging processes regarding women.
  Expands research efforts into the underlying causes and prevention of 
cardiovascular diseases in women--the leading cause of death among 
American women.
  Supports data collection through the National Center for Health 
Statistics and the National Program of Cancer Registries, which are the 
leading sources of national data on the health status of women in the 
U.S.
  Supports the National Breast and Cervical Cancer Early Detection 
Program, which provides for regular screening for breast and cervical 
cancers to underserved women.
  Requires that the length of hospital stay after a mastectomy, 
lumpectomy or lymph node dissection be determined only by the 
physician, in consultation with the patient, and without the need to 
obtain authorization from the health plan. If a plan covers 
mastectomies, it also must cover breast reconstruction after a 
mastectomy.
  Makes health insurance more accessible and affordable by:
  Allowing self-employed people to deduct the full amount of their 
health care premiums.
  Making medical savings accounts available to everyone.
  Reforming cafeteria plans to let consumers save for future health 
care costs.
  Mr. President, this bill is a comprehensive bill of rights that will 
benefit all Americans, and I am proud to join with so many of my 
colleagues in introducing it.
  Mr. President, I want to take a moment to address some criticisms 
that have been made of our bill. These criticisms highlight some 
significant differences between our bill and the health care bill 
introduced by Senate Democrats. Mr. President, our bill does differ 
significantly from the Senate Democrats' bill.
  Our bill is the ``Patients' Bill of Rights.'' Theirs is the 
``Lawyers' Right to Bill.''
  Our bill lets doctors decide whether care is medically necessary. 
Theirs lets lawyers decide.
  Our bill empowers an independent medical expert to order an insurance 
company to pay for medically necessary care so that patients suffer no 
harm. Theirs allows trial lawyers to sue health plans after harm is 
done.
  Mr. President, when my insurance company tells me that they won't 
cover a service for my family, I want the ability to appeal that 
decision to a doctor who doesn't work for my insurance company. And I 
want that appeal handled promptly, so that my family receives the 
benefit. That is what our bill requires.
  The Democrats' bill creates new ways for trial lawyers to make money. 
According to a June 1998 study by Multinational Business Services, the 
Democrats' bill would create 56 new Federal causes of action--56 new 
reasons to sue people in Federal court.
  That's fine for trial lawyers, but it doesn't do much for patients. 
Patients want their claim disputes handled promptly and fairly. 
According to a study by the General Accounting Office, it takes an 
average of 25 months--more than two years--to resolve a malpractice 
suit. One cause that the GAO studied took 11 years to resolve! I'm sure 
the lawyers who handled that case did quite well for themselves. But 
what about the patient?
  Under our bill, patients can appeal directly to an outside medical 
expert for a prompt review of their claim--without having to incur any 
legal expenses. In medical malpractice litigation, patients receive an 
average of only 43 cents of every dollar awarded. The rest goes to 
lawyers and court fees.
  Our bill assures that health care dollars are used to serve patients. 
Their bill diverts these dollars away from patients and into the 
pockets of trial lawyers.
  Another big difference between our bill and the one introduced by 
Senate Democrats is that their bill takes a ``big government'' approach 
to health reform.
  Mr. President, it was just four years ago that we debated Clintoncare 
on the Senate floor. President Clinton wanted government-run health 
care for all Americans. He wanted it then; he wants it still.
  Just last September, President Clinton told the Service Employees 
Union that he was ``glad'' that he had pushed for the federal 
government to take over health care. ``Now if what I tried to do before 
won't work,'' the President said, ``maybe we can do it another way. A 
step at a time until we eventually finish this.''
  The Democrats' bill would take us a step closer to the President's 
dream of a health care system run by federal bureaucrats and trial 
lawyers. The study I cited earlier by Multinational Business Services 
found that their bill would impose 359 new federal mandates, 59 new 
sets of Federal regulations, and require the government to hire 3,828 
new federal bureaucrats.
  Our bill relies on State Insurance Commissioners to protect those 
Americans who are enrolled in state-regulated plans. We protect the 
unprotected by providing new federal safeguards to the 48 million 
Americans who are enrolled in plans that the states are not permitted 
to regulate.
  Their bill imposes a risky and complicated scheme that relies on 
federal bureaucrats at the Health Care Financing Administration (HCFA) 
to enforce patients' rights in states that do not conform to the 
federal mandates in their bill.
  HCFA is the agency that oversees the federal Medicare and Medicaid 
programs. Last year, in the Balanced Budget Act, Congress created new 
consumer protections for Medicare beneficiaries--a ``Patients' Bill of 
Rights'' for the 38.5 million senior citizens and disabled Americans 
who rely on Medicare for their health care.
  We asked HCFA to protect those rights. How have they done? I regret 
to say, Mr. President, that they have not done very well at all.
  On July 16, a GAO witness testified before the Ways and Means 
Committee on how well HCFA was doing in enforcing the Medicare 
patients' bill of rights. According to GAO, HCFA has ``missed 25 
percent of the implementation deadlines, including the quality-of-care 
medical review process for skilled nursing facilities. It is clear

[[Page S8489]]

that HCFA will continue to miss implementation deadlines as it attempts 
to balance the resource demands generated by the Balanced Budget Act 
with other competing objectives.''
  Mr. President, I won't detail all of the ways that HCFA has failed--
the fact that it is delaying implementation of a prostate screening 
program to which Medicare beneficiaries are entitled, the fact that it 
has failed to establish a quality-of-care medical review process for 
skilled nursing facilities, the fact that it is far behind schedule in 
developing a new payment system for home health services. The list goes 
on and on.
  But let me focus on one failure that is especially relevant. All of 
us agree that people have the right to information about their health 
plans. When they have the choice of more than one plan, accurate 
information that compares the plans is critical.
  Last year, Congress allocated $95 million to HCFA to develop an 
information and education program for Medicare beneficiaries. This 
money was to be used for publishing and mailing handbooks containing 
comparative plan information to seniors, establishing a toll-free 
number and Internet website, and sponsoring health information fairs.
  Well, there haven't been any information fairs and the toll-free 
number isn't operational. They do have a website, but they've decided 
to mail comparative information handbooks only to seniors in 5 states: 
Washington, Oregon, Ohio, Florida and Arizona. So for the princely sum 
of a $95 million, only about 5.5 million seniors will receive important 
information about their health plans, leaving 32.5 million seniors 
without these handbooks. At that rate, HCFA would need more than $1 
billion each year just for handbooks.
  Mr. President, if this agency is struggling to protest the rights of 
38.5 million Medicare beneficiaries, how can we ask it to protect the 
rights of up as many as 100 million people enrolled in private health 
plans?
  We believe that consumer protections are too important to entrust to 
a cumbersome and inefficient federal government. State governments have 
long been in the business of insurance regulation and the federal 
government should not usurp their role.
  The federal government should protect those who are enrolled in plans 
that are exempt from state regulation and those enrolled in the 
programs it runs, like Medicare and Medicaid. The federal government 
should start protecting the rights of senior citizens under Medicare, 
instead of meddling in areas where it doesn't belong.
  Mr. President, our bill is a truly comprehensive bill of rights for 
patients, providing new consumer protections for the 48 million 
Americans who are unprotected by state law, giving the 124 million 
Americans enrolled in employer-sponsored plans new rights to appeal 
adverse coverage decisions, protecting the civil rights of consumers to 
gain access to their medical records, protecting consumers against 
discrimination based on genetic tests, promoting quality improvement, 
establishing a new women's health initiative, and giving millions of 
Americans access to affordable health insurance through medical savings 
accounts.
  The doctor-patient relationship is one of the most important in 
people's lives. Our legislation preserves and protects that 
relationship, while taking many common-sense steps forward to affirm 
and expand quality and access. I look forward with my colleagues and 
many cosponsors, to the floor debate on this vital issue.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2330

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Patients' 
     Bill of Rights Act''.
       (b) Table Of Contents.--The table of contents for this Act 
     is as follows:

Sec. 1. Short title; table of contents.

                    TITLE I--PATIENT BILL OF RIGHTS

                  Subtitle A--Right to Advice and Care

Sec. 101. Patient right to medical advice and care.


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

``Sec. 721. Patient access to emergency medical care.
``Sec. 722. Offering of choice of coverage options.
``Sec. 723. Patient access to obstetric and gynecological care.
``Sec. 724. Patient access to pediatric care.
``Sec. 725. Continuity of care.
``Sec. 726. Protection of patient-provider communications.
``Sec. 727. Generally applicable provisions.
Sec. 102. Effective date and related rules.

       Subtitle B--Right to Information About Plans and Providers

Sec. 111. Information about plans.
Sec. 112. Information about providers.

           Subtitle C--Right to Hold Health Plans Accountable

Sec. 121. Amendment to Employee Retirement Income Security Act of 1974.

     TITLE II--INDIVIDUAL RIGHTS WITH RESPECT TO PERSONAL MEDICAL 
                              INFORMATION

Sec. 201. Short title.

                 Subtitle A--Access to Medical Records

Sec. 211. Inspection and copying of protected health information.
Sec. 212. Amendment of protected health information.
Sec. 213. Notice of confidentiality practices.

                Subtitle B--Establishment of Safeguards

Sec. 221. Establishment of safeguards.

                  Subtitle C--Enforcement; Definitions

Sec. 231. Civil penalty.
Sec. 232. Definitions.

              TITLE III--GENETIC INFORMATION AND SERVICES

Sec. 301. Short title.
Sec. 302. Amendments to Employee Retirement Income Security Act of 
              1974.
Sec. 303. Amendments to the Public Health Service Act.
Sec. 304. Amendments to the Internal Revenue Code of 1986.

                 TITLE IV--HEALTHCARE QUALITY RESEARCH

Sec. 401. Short title.
Sec. 402. Amendment to the Public Health Service Act.

           ``TITLE IX--AGENCY FOR HEALTHCARE QUALITY RESEARCH

               ``Part A--Establishment and General Duties

``Sec. 901. Mission and duties.
``Sec. 902. General authorities.

               ``Part B--Healthcare Improvement Research

``Sec. 911. Healthcare outcome improvement research.
``Sec. 912. Private-public partnerships to improve organization and 
              delivery.
``Sec. 913. Information on quality and cost of care.
``Sec. 914. Information systems for healthcare improvement.
``Sec. 915. Research supporting primary care delivery and access in 
              underserved areas.
``Sec. 916. Clinical practice and technology innovation.
``Sec. 917. Coordination of Federal Government quality improvement 
              efforts.

          ``Part C--Foundation for Healthcare Quality Research

``Sec. 921. Foundation for Healthcare Quality Research.

                      ``Part D--General Provisions

``Sec. 931. Advisory Council for Healthcare Quality Research.
``Sec. 932. Peer review with respect to grants and contracts.
``Sec. 933. Certain provisions with respect to development, collection, 
              and dissemination of data.
``Sec. 934. Dissemination of information.
``Sec. 935. Additional provisions with respect to grants and contracts.
``Sec. 936. Certain administrative authorities.
``Sec. 937. Funding.
``Sec. 938. Definitions.
Sec. 403. References.
Sec. 404. Study.

            TITLE V--WOMEN'S HEALTH RESEARCH AND PREVENTION

Sec. 501. Short title.

   Subtitle A--Provisions Relating to Women's Health Research at the 
                     National Institutes of Health

Sec. 511. Extension of program for research and authorization of 
              national program of education regarding the drug DES.
Sec. 512. Research on osteoporosis, Paget's disease, and related bone 
              disorders.
Sec. 513. Research on cancer.
Sec. 514. Research on heart attack, stroke, and other cardiovascular 
              diseases in women.
Sec. 515. Aging processes regarding women.
Sec. 516. Office of Research on Women's Health.

 Subtitle B--Provisions Relating to Women's Health at the Centers for 
                     Disease Control and Prevention

Sec. 521. National Center for Health Statistics.

[[Page S8490]]

Sec. 522. National program of cancer registries.
Sec. 523. National breast and cervical cancer early detection program.
Sec. 524. Centers for Research and Demonstration of Health Promotion.
Sec. 525. Community programs on domestic violence.

              Subtitle C--Women's Health and Cancer Rights

Sec. 531. Short title.
Sec. 532. Findings.
Sec. 533. Amendments to the Employee Retirement Income Security Act of 
              1974.
Sec. 534. Amendments to the Public Health Service Act relating to the 
              group market.
Sec. 535. Amendment to the Public Health Service Act relating to the 
              individual market.
Sec. 536. Amendments to the Internal Revenue Code of 1986.
Sec. 537. Research study on the management of breast cancer.

         TITLE VI--ENHANCED ACCESS TO HEALTH INSURANCE COVERAGE

Sec. 601. Carryover of unused benefits from cafeteria plans, flexible 
              spending arrangements, and health flexible spending 
              accounts.
Sec. 602. Full deduction of health insurance costs for self-employed 
              individuals.
Sec. 603. Full availability of medical savings accounts.
Sec. 604. Permitting contribution towards medical savings account 
              through Federal employees health benefits program 
              (FEHBP).

                    TITLE I--PATIENT BILL OF RIGHTS

                  Subtitle A--Right to Advice and Care

     SEC. 101. PATIENT RIGHT TO MEDICAL ADVICE AND CARE.

       (a) In General.--Part 7 of subtitle B of title I of the 
     Employee Retirement Income Security Act of 1974 (29 U.S.C. 
     1185 et seq.) is amended--
       (1) by redesignating subpart C as subpart D; and
       (2) by inserting after subpart B the following:

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

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

       ``(a) In General.--To the extent that the group health plan 
     provides coverage for benefits consisting of emergency 
     medical care (as defined in subsection (c)), except for items 
     or services specifically excluded--
       ``(1) the plan shall provide coverage for benefits, without 
     requiring preauthorization, for appropriate emergency medical 
     screening examinations (within the capability of the 
     emergency facility) to the extent that a prudent layperson, 
     who possesses an average knowledge of health and medicine, 
     would determine such examinations to be necessary to 
     determine whether emergency medical care (as so defined) is 
     necessary, and
       ``(2) the plan shall provide coverage for benefits for 
     additional emergency medical services following an emergency 
     medical screening examination (if determined necessary under 
     paragraph (1)) to the extent that a prudent emergency medical 
     professional would determine such additional emergency 
     services to be necessary to avoid the consequences described 
     in paragraph (2) of subsection (c).
       ``(b) Uniform Cost-Sharing Required.--Nothing in this 
     section shall be construed as preventing a group health plan 
     from imposing any form of cost-sharing applicable to any 
     participant or beneficiary (including coinsurance, 
     copayments, deductibles, and any other charges) in relation 
     to coverage for benefits described in subsection (a), if such 
     form of cost-sharing is uniformly applied under such plan, 
     with respect to similarly situated participants and 
     beneficiaries, to all benefits consisting of emergency 
     medical care (as defined in subsection (c)) provided to such 
     similarly situated participants and beneficiaries under the 
     plan.
       ``(c) Definition of Emergency Medical Care.--In this 
     section:
       ``(1) In general.--The term ``emergency medical care'' 
     means, with respect to a participant or beneficiary under a 
     group health plan, covered inpatient and outpatient services 
     that--
       ``(A) are furnished by a provider that is qualified to 
     furnish such services; and
       ``(B) are needed to evaluate or stabilize an emergency 
     medical condition (as defined in paragraph (2)).
       ``(2) Emergency medical condition.--The term ``emergency 
     medical care'' means a medical condition manifesting itself 
     by acute symptoms of sufficient severity (including severe 
     pain) such that a prudent layperson, who possesses an average 
     knowledge of health and medicine, could reasonably expect the 
     absence of immediate medical attention to result in--
       ``(A) placing the health of the participant or beneficiary 
     (or, with respect to a pregnant woman, the health of the 
     woman or her unborn child) in serious jeopardy,
       ``(B) serious impairment to bodily functions, or
       ``(C) serious dysfunction of any bodily organ or part.

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

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

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

       ``(a) In General.--In any case in which a group health 
     plan--
       ``(1) provides coverage for benefits consisting of--
       ``(A) gynecological care (such as preventive women's health 
     examinations); or
       ``(B) obstetric care (such as pregnancy-related services);
     provided by a participating physician who specializes in such 
     care; and
       ``(2) 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 physician as described in 
     paragraph (1), then the plan shall meet the requirements of 
     subsection (b).
       ``(b) Requirements.--A group health plan meets the 
     requirements of this subsection, in connection with the 
     coverage of benefits described in subsection (a) consisting 
     of care described in subparagraph (A) or (B) of subsection 
     (a)(1), if the plan--
       ``(1) does not require authorization or a referral by the 
     primary care provider in order to obtain coverage for such 
     benefits, and
       ``(2) treats the ordering of other routine care of the same 
     type, by the participating physician providing the care 
     described in subparagraph (A) or (B) of subsection (a)(1), as 
     the authorization of the primary care provider with respect 
     to such care.
       ``(c) Rule of Construction.--Nothing in subsection (b)(2) 
     shall waive any requirements of coverage relating to medical 
     necessity or appropriateness with respect to coverage of 
     gynecological or obstetric care so ordered.

     ``SEC. 724. PATIENT ACCESS TO PEDIATRIC CARE.

       ``(a) In General.--In any case in which a group health 
     plan--
       ``(1) provides coverage for benefits consisting of 
     pediatric care by a participating pediatrician; and
       ``(2) 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 a physician as described in paragraph 
     (1), then the plan shall meet the requirements of subsection 
     (b).
       ``(b) Requirements.--A group health plan meets the 
     requirements of this subsection, in connection with the 
     coverage of benefits described in subsection (a) consisting 
     of care described in subsection (a)(1), if the plan--
       ``(1) does not require authorization or a referral by the 
     primary care provider in order to obtain coverage for such 
     benefits, and
       ``(2) treats the ordering of other routine care of the same 
     type, by the participating

[[Page S8491]]

     physician providing the care described in subsection (a)(1), 
     as the authorization of the primary care provider with 
     respect to such care.
       ``(c) Construction.--Nothing in subsection (b)(2) shall 
     waive any requirements of coverage relating to medical 
     necessity or appropriateness with respect to coverage of 
     pediatric care so ordered.

     ``SEC. 725. CONTINUITY OF CARE.

       ``(a) In General.--
       ``(1) Termination of provider.--If a contract between a 
     group health plan and a health care provider is terminated 
     (as defined in paragraph (2)), or benefits or coverage 
     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 is a participant or 
     beneficiary in the plan is undergoing a course of treatment 
     from the provider at the time of such termination, the plan 
     shall--
       ``(A) notify the individual on a timely basis of such 
     termination, and
       ``(B) in the case of termination described in paragraph 
     (2), (3), of (4) of subsection (b), and subject to subsection 
     (c), permit the individual to continue or be covered with 
     respect to the course of treatment with the provider's 
     consent during a transitional period (as provided under 
     subsection (b)).
       ``(2) Termination.--In this section, the term `terminated' 
     includes, with respect to a contract, the expiration or 
     nonrenewal of the contract by the group health plan, but does 
     not include a termination of the contract by the plan for 
     failure to meet applicable quality standards or for fraud.
       ``(b) Transitional Period.--
       ``(1) General rule.--Except as provided in paragraph (3), 
     the transitional period under this subsection shall extend 
     for up to 90 days from the date of the notice described in 
     subsection (a)(1)(A) of the provider's termination.
       ``(2) Institutional care.--Subject to paragraph (1), the 
     transitional period under this subsection for institutional 
     or inpatient care from a provider shall extend until the 
     discharge or termination of the period of 
     institutionalization and also shall include institutional 
     care provided within a reasonable time of the date of 
     termination of the provider status if the care was scheduled 
     before the date of the announcement of the termination of the 
     provider status under subsection (a)(1)(A) or if the 
     individual on such date was on an established waiting list or 
     otherwise scheduled to have such care.
       ``(3) Pregnancy.--Notwithstanding paragraph (1), if--
       ``(A) a participant or beneficiary has entered the second 
     trimester of pregnancy at the time of a provider's 
     termination of participation; and
       ``(B) the provider was treating the pregnancy before the 
     date of the termination;

     the transitional period under this subsection with respect to 
     provider's treatment of the pregnancy shall extend through 
     the provision of post-partum care directly related to the 
     delivery.
       ``(4) Terminal illness.--Subject to paragraph (1), if--
       ``(A) a participant or beneficiary was determined to be 
     terminally ill (as determined under section 1861(dd)(3)(A) of 
     the Social Security Act) prior to a provider's termination of 
     participation; and
       ``(B) the provider was treating the terminal illness before 
     the date of termination;

     the transitional period under this subsection shall extend 
     for the remainder of the individual's life for care directly 
     related to the treatment of the terminal illness.
       ``(c) Permissible Terms and Conditions.--A group health 
     plan may condition coverage of continued treatment by a 
     provider under subsection (a)(1)(B) upon the provider 
     agreeing to the following terms and conditions:
       ``(1) 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 subsection (b)(2), at the rates applicable under 
     the replacement plan after the date of the termination of the 
     contract with the group health plan) and not to impose cost-
     sharing with respect to the individual in an amount that 
     would exceed the cost-sharing that could have been imposed if 
     the contract referred to in subsection (a)(1) had not been 
     terminated.
       ``(2) The provider agrees to adhere to the quality 
     assurance standards of the plan responsible for payment under 
     paragraph (1) and to provide to such plan necessary medical 
     information related to the care provided.
       ``(3) The 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) Rule of Construction.--Nothing in this section shall 
     be construed to require the coverage of benefits which would 
     not have been covered if the provider involved remained a 
     participating provider.
       ``(e) Definition.--In this section, the term `health care 
     provider' or `provider' means--
       ``(1) any individual who is engaged in the delivery of 
     health care services in a State and who is required by State 
     law or regulation to be licensed or certified by the State to 
     engage in the delivery of such services in the State; and
       ``(2) any entity that is engaged in the delivery of health 
     care services in a State and that, if it is required by State 
     law or regulation to be licensed or certified by the State to 
     engage in the delivery of such services in the State, is so 
     licensed.

     ``SEC. 726. PROTECTION OF PATIENT-PROVIDER COMMUNICATIONS.

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

     ``SEC. 727. GENERALLY APPLICABLE PROVISIONS.

       ``(a) Applicability.--The provisions of this subpart shall 
     apply to group health plans. Such provisions shall not apply 
     to a health insurance issuer that is licensed by a State and 
     subject to State laws that regulate insurance within the 
     meaning of section 514(b)(2), while engaged in the business 
     of insurance in such State.
       ``(b) Treatment of multiple coverage options.--In the case 
     of a group health plan that provides benefits under 2 or more 
     coverage options, the requirements of sections 721, 723, 724, 
     725 and 726 shall apply separately with respect to each 
     coverage option.''.
       (b) Rule with Respect to Certain Plans.--
       (1) In general.--Notwithstanding any other provision of 
     law, health insurance issuers may offer, and eligible 
     individuals may purchase, high deductible health plans 
     described in section 220(c)(2)(A) of the Internal Revenue 
     Code of 1986. Effective for the 4-year period beginning on 
     the date of the enactment of this Act, such health plans 
     shall not be required to provide payment for any health care 
     items or services that are exempt from the plan's deductible.
       (2) Existing state laws.--A State law relating to payment 
     for health care items and services in effect on the date of 
     enactment of this Act that is preempted under paragraph (1), 
     shall not apply to high deductible health plans after the 
     expiration of the 4-year period described in such paragraph 
     unless the State reenacts such law after such period.
       (c) Conforming Amendment.--The table of contents in section 
     1 of such Act is amended--
       (1) in the item relating to subpart C, by striking 
     ``Subpart C'' and inserting ``Subpart D''; and
       (2) by adding at the end of the items relating to subpart B 
     of part 7 of subtitle B of title I of such Act the following 
     new items:

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

``Sec. 721. Patient access to emergency medical care.
``Sec. 722. Offering of choice of coverage options.
``Sec. 723. Patient access to obstetric and gynecological care.
``Sec. 724. Patient access to pediatric care.
``Sec. 725. Continuity of care.
``Sec. 726. Protection of patient-provider communications.
``Sec. 727. Generally applicable provisions.''.

     SEC. 102. EFFECTIVE DATE AND RELATED RULES.

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

       Subtitle B--Right to Information About Plans and Providers

     SEC. 111. INFORMATION ABOUT PLANS.

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

     ``SEC. 713. HEALTH PLAN COMPARATIVE INFORMATION.

       ``(a) Requirement.--A group health plan, or health 
     insurance issuer in connection with group health insurance 
     coverage, shall, not later than 12 months after the date of 
     enactment of this section, provide for the disclosure, in a 
     clear and accurate form to each enrollee, or upon request to 
     a potential enrollee eligible to receive benefits under the 
     plan, or plan sponsor with which the plan or issuer has 
     contracted, of the information described in subsection (b).
       ``(b) Required Information.--The informational materials to 
     be distributed under this section shall include for each 
     health benefit plan the following:
       ``(1) A description of the covered items and services under 
     each such plan and any in- and out-of-network features of 
     each such plan.

[[Page S8492]]

       ``(2) A description of any cost-sharing, including 
     premiums, deductibles, coinsurance, and copayment amounts, 
     for which the enrollee will be responsible, including any 
     annual or lifetime limits on benefits, for each such plan.
       ``(3) A description of any optional supplemental benefits 
     offered by each such plan and the terms and conditions 
     (including premiums or cost-sharing) for such supplemental 
     coverage.
       ``(4) A description of any restrictions on payments for 
     services furnished to an enrollee by a health care 
     professional that is not a participating professional and the 
     liability of the enrollee for additional payments for these 
     services.
       ``(5) A description of the service area of each such plan, 
     including the provision of any out-of-area coverage.
       ``(6) A description of the extent to which enrollees may 
     select the primary care provider of their choice, including 
     providers both within the network and outside the network of 
     each such plan (if the plan permits out-of-network services).
       ``(7) A description of the procedures for advance 
     directives and organ donation decisions if the plan maintains 
     such procedures.
       ``(8) A description of the requirements and procedures to 
     be used to obtain preauthorization for health services 
     (including telephone numbers and mailing addresses), 
     including referrals for specialty care.
       ``(9) A summary of the rules and methods for appealing 
     coverage decisions and filing grievances (including telephone 
     numbers and mailing addresses), as well as other available 
     remedies.
       ``(10) A summary of the rules for access to emergency room 
     care. Also, any available educational material regarding 
     proper use of emergency services.
       ``(11) A description of whether or not coverage is provided 
     for experimental treatments, investigational treatments, or 
     clinical trials and the circumstances under which access to 
     such treatments or trials is made available.
       ``(12) A description of the specific preventative services 
     covered under the plan if such services are covered.
       ``(13) A statement that the following information, and 
     instructions on obtaining such information (including 
     telephone numbers and, if available, Internet websites), 
     shall be made available upon request:
       ``(A) The names, addresses, telephone numbers, and State 
     licensure status of the plan's participating health care 
     professionals and participating health care facilities, and, 
     if available, the education, training, speciality 
     qualifications or certifications of such professionals.
       ``(B) A summary description of the methods used for 
     compensating participating health care professionals, such as 
     capitation, fee-for-service, salary, or a combination 
     thereof. The requirement of this subparagraph shall not be 
     construed as requiring plans to provide information 
     concerning proprietary payment methodology.
       ``(C) A summary description of the methods used for 
     compensating health care facilities, including per diem, fee-
     for-service, capitation, bundled payments, or a combination 
     thereof. The requirement of this subparagraph shall not be 
     construed as requiring plans to provide information 
     concerning proprietary payment methodology.
       ``(D) A summary description of the procedures used for 
     utilization review.
       ``(E) The list of the specific prescription medications 
     included in the formulary of the plan, if the plan uses a 
     defined formulary, and any provision for obtaining off-
     formulary medications.
       ``(F) A description of the specific exclusions from 
     coverage under the plan.
       ``(G) Any available information related to the availability 
     of translation or interpretation services for non-English 
     speakers and people with communication disabilities, 
     including the availability of audio tapes or information in 
     Braille.
       ``(H) Any information that is made public by accrediting 
     organizations in the process of accreditation if the plan is 
     accredited, or any additional quality indicators that the 
     plan makes available.
       ``(c) Manner of Distribution.--
       ``(1) In general.--The information described in this 
     section shall be distributed in an accessible format that is 
     understandable to an average plan enrollee.
       ``(2) Rule of construction.--For purposes of this section, 
     a group health plan, or health insurance issuer in connection 
     with group health insurance coverage, in reliance on records 
     maintained by the plan or issuer, shall be deemed to have met 
     the requirements of this section if the plan or issuer 
     provides the information requested under this section--
       ``(A) in the case of the plan, to participants and 
     beneficiaries at the address contained in such records with 
     respect to such participants and beneficiaries; or
       ``(B) in the case of the issuer, to the employer of a 
     participant if the employer provides for the coverage of such 
     participant under the plan involved or to participants and 
     beneficiaries at the address contained in such records with 
     respect to such participants and beneficiaries.
       ``(d) Rule of Construction.--Nothing in this section may be 
     construed to prohibit a group health plan, or health 
     insurance issuer in connection with group health insurance 
     coverage, from distributing any other additional information 
     determined by the plan or issuer to be important or necessary 
     in assisting participants and beneficiaries enrollees or upon 
     request potential participants in the selection of a health 
     plan or from providing information under subsection (b)(13) 
     as part of the required information.
       ``(e) Health care professional.--In this section, the term 
     `health care professional' means a physician (as defined in 
     section 1861(r) of the Social Security Act) or other health 
     care professional if coverage for the professional's services 
     is provided under the health plan involved for the services 
     of the professional. Such term includes a podiatrist, 
     optometrist, chiropractor, psychologist, dentist, physician 
     assistant, physical or occupational therapist and therapy 
     assistant, speech-language pathologist, audiologist, 
     registered or licensed practical nurse (including nurse 
     practitioner, clinical nurse specialist, certified registered 
     nurse anesthetist, and certified nurse-midwife), licensed 
     certified social worker, registered respiratory therapist, 
     and certified respiratory therapy technician.''.
       (b) Conforming Amendments.--
       (1) Section 732(a) of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1185(a)) is amended by 
     striking ``section 711, and inserting ``sections 711 and 
     713''.
       (2) The table of contents in section 1 of the Employee 
     Retirement Income Security Act of 1974 (29 U.S.C. 1001) is 
     amended by inserting after the item relating to section 712, 
     the following:
``Sec. 713. Health plan comparative information.''.

     SEC. 112. INFORMATION ABOUT PROVIDERS.

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

           Subtitle C--Right to Hold Health Plans Accountable

     SEC. 121. AMENDMENT TO EMPLOYEE RETIREMENT INCOME SECURITY 
                   ACT OF 1974.

       (a) In General.--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 an enrollee 
     is eligible to receive a payment or coverage for health 
     services under the plan or coverage involved and any cost-
     sharing amount that the enrollee is required to pay with 
     respect to such service;
       ``(ii) notifying covered enrollees (or the legal 
     representative of such enrollees) and the treating health 
     care professionals involved regarding determinations made 
     under the plan or issuer and any additional payments that the 
     enrollee 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 an 
     enrollee (or the legal representative of such enrollee) or 
     the treating health care professional.
       ``(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

[[Page S8493]]

     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 after a 
     request is received by the plan or issuer under clause (ii) 
     or (iii).
       ``(ii) Request by enrollee.--A plan or issuer shall 
     maintain procedures for expediting a prior authorization 
     determination under this subsection upon the request of an 
     enrollee 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 enrollee.
       ``(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 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 enrollee.
       ``(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 all 
     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 enrollee (or the legal representative of the enrollee), 
     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 enrollee (or the legal representative of the enrollee), 
     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 (1) 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 enrollee involved (or the legal representative of the 
     enrollee) within 1 working day of the date on which the 
     initial notice was issued.
       ``(D) Retrospective reviews.--With respect to the 
     retrospective review under a plan or issuer of a 
     determination made under paragraph (1), a determination shall 
     be made within 30 working days of the date on which the plan 
     or issuer receives all necessary information. The plan or 
     issuer shall issue written notice of an approval or 
     disapproval of a determination under this subparagraph to the 
     enrollee (or the legal representative of the enrollee) 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 or electronic 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 enrollee (or the legal 
     representative of the enrollee) 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 enrollee;
       ``(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 and enrollees. Determinations 
     under such procedures shall be non-appealable.
       ``(d) Internal Appeal of Coverage Determinations.--
       ``(1) In general.--An enrollee (or the legal representative 
     of the enrollee) and the treating health care professional 
     with the consent of the enrollee (or the legal representative 
     of the enrollee), may appeal any adverse coverage 
     determination under subsection (b) under the procedures 
     described in 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.
       ``(3) Routine determinations.--A group health plan or a 
     health insurance issuer shall provide for 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 enrollee.--A plan or issuer shall maintain 
     procedures for expediting a prior authorization determination 
     under this subsection upon the request of an enrollee 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 enrollee.
       ``(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 documented, based on the medical exigencies 
     that a determination under the procedures described in 
     paragraph (2) could seriously jeopardize the life or health 
     of the enrollee.
       ``(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 involved in 
     the initial determination.
       ``(6) Lack of medical necessity.--An appeal under this 
     subsection relating to a determination to deny coverage based 
     on a lack of medical necessity or appropriateness, or based 
     on an experimental or investigational treatment, shall be 
     made only by a physician with appropriate expertise in the 
     field of medicine involved 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 
     enrollee (or the legal representative of the enrollee) 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 enrollee;
       ``(ii) the procedures for obtaining additional information 
     concerning the determination; and
       ``(iii) notification of the right to an external review 
     under subsection (e) and instructions on how to initiate such 
     a review.
       ``(e) External Review.--
       ``(1) In general.--A group health plan or a health 
     insurance issuer shall have written procedures to permit an 
     enrollee (or the legal representative of the enrollee) access 
     to an external review with respect to a coverage 
     determination concerning a particular item or service where 
     the plan, in consultation with the plan's legal 
     representative, has determined that--
       ``(A) the particular item or service involved, when 
     medically appropriate and necessary, is generally a covered 
     benefit under the terms and conditions of the contract 
     between the plan or issuer and the enrollee;
       ``(B) the coverage determination involved denied coverage 
     for such item or service because the provision of such item 
     or service--
       ``(i) does not meet the plan's or issuer's requirements for 
     medical appropriateness or necessity and the amount involved 
     exceeds $1,000; or
       ``(ii) would constitute experimental or investigational 
     treatment and there is a significant risk of placing the life 
     or health of the enrollee in jeopardy; and
       ``(C) the enrollee has completed the internal appeals 
     process with respect to such determination.
       ``(2) Initiation of the external review process.--
       ``(A) Filing of request.--An enrollee (or the legal 
     representative of the enrollee) who desires to have an 
     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 enrollee (or the 
     legal representative of the enrollee) for the release of 
     medical information and records to external reviewers 
     regarding the enrollee if such information is necessary for 
     the proper conduct of the external review.
       ``(B) Information and notice.--Not later than 5 working 
     days after the receipt of a request under subparagraph (A), 
     the plan or issuer involved shall select an external appeals 
     entity under paragraph (3)(A) that shall be responsible for 
     designating an external reviewer under paragraph (3)(B).
       ``(C) Provision of information.--The plan or issuer 
     involved shall forward all 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 enrollee for the 
     coverage denial, and evidence of the enrollee's coverage) to 
     the

[[Page S8494]]

     external reviewer selected under paragraph (3)(B).
       ``(D) Notification.--The plan or issuer involved shall send 
     a written notification to the enrollee (or the legal 
     representative of the enrollee) and the plan administrator, 
     indicating that an external review has been initiated.
       ``(3) Conduct of external review.--
       ``(A) Designation of external appeals entity by plan or 
     issuer.--A plan or issuer that receives a request for an 
     external review under paragraph (2)(A) shall designate one of 
     the following entities to serve as the external appeals 
     entity:
       ``(i) An 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 external review services.
       ``(iv) Any entity accredited as an external review entity 
     by an accrediting body recognized by the Secretary for such 
     purpose.
       ``(v) Any fully accredited teaching hospital.
       ``(vi) Any other entity meeting criteria established by the 
     Secretary for purposes of this subparagraph.
       ``(B) Designation of external reviewer by external appeals 
     entity.--The external appeals entity designated under 
     subparagraph (A) shall designate one or more individuals to 
     serve as external reviewers with respect to a request 
     receives 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 
     enrollee involved, the treating health care professional, the 
     institution where the treatment would take place, or the 
     manufacturer or any drug, device, procedure, or other therapy 
     proposed for the enrollee whose treatment is under review;
       ``(iii) be experts in the treatment of the enrollee's 
     medical condition and knowledgeable about the recommended 
     therapy;
       ``(iv) receive only reasonable and customary compensation 
     from the group health plan or health insurance issuer in 
     connection with the 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 external reviewer shall--
       ``(i) make a determination based on the medical necessity, 
     appropriateness, experimental or investigational nature of 
     the coverage denial;
       ``(ii) take into consideration any evidence-based decision 
     making or clinical practice guidelines used by the group 
     health plan or health insurance issuer in conducting 
     utilization review; or
       ``(iii) submit a report on the final determinations of the 
     review involved to--

       ``(I) the plan or issuer involved;
       ``(II) the enrollee involved (or the legal representative 
     of the enrollee); and
       ``(III) the health care professional involved.

       ``(B) Notice.--The plan or issuer involved shall ensure 
     that the enrollee 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 external review.
       ``(5) Timeframe for review.--An external reviewer shall 
     complete a review of an adverse coverage determination in 
     accordance with the medical exigencies of the case, but in no 
     case later than 30 working days after the later of--
       ``(A) the date on which such reviewer is designated; or
       ``(B) the date on which all information necessary to 
     completing such review is received.
       ``(6) Binding determination.--The determination of an 
     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 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 external reviews. Such study shall include an 
     assessment of the process involved during an external review 
     and the basis of decisionmaking by the external reviewer. The 
     results of such study shall be submitted to the appropriate 
     committees of Congress.
       ``(8) Continuing legal rights of enrollees.--Nothing in 
     this section shall be construed as removing any legal rights 
     of participants, beneficiaries, enrollees, and others under 
     State or Federal law, including the right to file judicial 
     actions to enforce rights.
       ``(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 
     external review by an 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) Enrollee.--The term enrollee means a participant or 
     beneficiary.
       ``(4) Grievance.--The term `grievance' means any enrollee 
     complaint that does not involve a coverage determination.
       ``(5) 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.
       ``(6) 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 practitioner who is acting within the 
     scope of their State licensure or certification for the 
     delivery of health care services and who is primarily 
     responsible for delivering those services to the enrollee.
       ``(7) 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, 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 strike the item relating to section 503 and 
     inserting the following new item:

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

     TITLE II--INDIVIDUAL RIGHTS WITH RESPECT TO PERSONAL MEDICAL 
                              INFORMATION

     SEC. 201. SHORT TITLE.

       This title may be cited as the ''Personal Medical 
     Information Access Act''.

                 Subtitle A--Access to Medical Records

     SEC. 211. INSPECTION AND COPYING OF PROTECTED HEALTH 
                   INFORMATION.

       (a) In General.--At the request of an individual and except 
     as provided in subsection (b), a health care provider, health 
     plan, employer, health or life insurer, school, or university 
     shall permit an individual who is the subject of protected 
     health information or the individual's designee, to inspect 
     and copy protected health information concerning the 
     individual, including records created under section 212 that 
     such entity maintains. Such entity may set forth appropriate 
     procedures to be followed for such inspection or copying and 
     may require an individual to pay reasonable costs associated 
     with such inspection or copying.
       (b) Exceptions.--Unless ordered by a court of competent 
     jurisdiction, an entity described in subsection (a) is not 
     required to permit the inspection or copying of protected 
     health information if any of the following conditions are 
     met:
       (1) Endangerment to life or safety.--The entity determines 
     that the disclosure of the information could reasonably be 
     expected to endanger the life or physical safety of an 
     individual.
       (2) Confidential source.--The information identifies, or 
     could reasonably lead to the identification of, a person who 
     provided information under a promise of confidentiality 
     concerning the individual who is the subject of the 
     information.
       (3) Information compiled in anticipation of litigation.--
     The information is compiled principally--
       (A) in the reasonable anticipation of a civil, criminal, or 
     administrative action or proceeding; or
       (B) for use in such an action or proceeding.
       (4) Research purposes.--The information was collected for a 
     research project monitored by an institutional review board, 
     such project is not complete, and the researcher involved 
     reasonably believes that access to such information would 
     harm the conduct of the research or invalidate or 
     undermine the validity of the research.
       (c) Denial of a Request for Inspection or Copying.--If an 
     entity described in subsection (a) denies a request for 
     inspection or copying pursuant to subsection (b), the entity 
     shall inform the individual in writing of--
       (1) the reasons for the denial of the request for 
     inspection or copying;
       (2) any procedures for further review of the denial; and
       (3) the individual's right to file with the entity a 
     concise statement setting forth the request for inspection or 
     copying.

[[Page S8495]]

       (d) Statement Regarding Request.--If an individual has 
     filed a statement under subsection (c)(3), the entity in any 
     subsequent disclosure of the portion of the information 
     requested under subsection (a) shall include--
       (1) a copy of the individual's statement; and
       (2) a concise statement of the reasons for denying the 
     request for inspection or copying.
       (e) Inspection and Copying of Segregable Portion.--An 
     entity described in subsection (a) shall permit the 
     inspection and copying under subsection (a) of any reasonably 
     segregable portion of protected health information after 
     deletion of any portion that is exempt under subsection (b).
       (f) Deadline.--An entity described in subsection (a) shall 
     comply with or deny, in accordance with subsection (c), a 
     request for inspection or copying of protected health 
     information under this section not later than 45 days after 
     the date on which the entity receives the request.
       (g) Rules Governing Agents.--An agent of an entity 
     described in subsection (a) shall not be required to provide 
     for the inspection and copying of protected health 
     information, except where--
       (1) the protected health information is retained by the 
     agent; and
       (2) the agent has received in writing a request from the 
     entity involved to fulfill the requirements of this section;

     at which time such information shall be provided to the 
     requesting entity. Such requesting entity shall comply with 
     subsection (f) with respect to any such information.
       (h) Rule of Construction.--This section shall not be 
     construed to require an entity described in subsection (a) to 
     conduct a formal, informal, or other hearing or proceeding 
     concerning a request for inspection or copying of protected 
     health information.

     SEC. 212. AMENDMENT OF PROTECTED HEALTH INFORMATION.

       (a) Requirement.--
       (1) In general.--Except as provided in subsection (b) and 
     subject to paragraph (2), a health care provider, health 
     plan, employer, health or life insurer, school, or university 
     that receives from an individual a request in writing to 
     amend protected health information shall--
       (A) amend such information as requested;
       (B) inform the individual of the amendment that has been 
     made; and
       (C) make reasonable efforts to inform any person to whom 
     the unamended portion of the information was previously 
     disclosed, of any nontechnical amendment that has been made.
       (2) Compliance.--An entity described in paragraph (1) shall 
     comply with the requirements of such paragraph within 45 days 
     of the date on which the request involved is received if the 
     entity--
       (A) created the protected health information involved; and
       (B) determines that such information is in fact inaccurate.
       (b) Refusal To Amend.--If an entity described in subsection 
     (a) refuses to make the amendment requested under such 
     subsection, the entity shall inform the individual in writing 
     of--
       (1) the reasons for the refusal to make the amendment;
       (2) any procedures for further review of the refusal; and
       (3) the individual's right to file with the entity a 
     concise statement setting forth the requested amendment and 
     the individual's reasons for disagreeing with the refusal.
       (c) Statement of Disagreement.--If an individual has filed 
     a statement of disagreement under subsection (b)(3), the 
     entity involved, in any subsequent disclosure of the disputed 
     portion of the information--
       (1) shall include a copy of the individual's statement; and
       (2) may include a concise statement of the reasons for not 
     making the requested amendment.
       (d) Rules Governing Agents.--The agent of an entity 
     described in subsection (a) shall not be required to make 
     amendments to protected health information, except where--
       (1) the protected health information is retained by the 
     agent; and
       (2) the agent has been asked by such entity to fulfill the 
     requirements of this section.
     If the agent is required to comply with this section as 
     provided for in paragraph (2), such agent shall be subject to 
     the 45-day deadline described in subsection (a).
       (e) Repeated Requests for Amendments.--If an entity 
     described in subsection (a) receives a request for an 
     amendment of information as provided for in such subsection 
     and a statement of disagreement has been filed pursuant to 
     subsection (c), the entity shall inform the individual of 
     such filing and shall not be required to carry out the 
     procedures required under this section.
       (f) Rules of Construction.--This section shall not be 
     construed to--
       (1) require that an entity described in subsection (a) 
     conduct a formal, informal, or other hearing or proceeding 
     concerning a request for an amendment to protected health 
     information;
       (2) require a provider to amend an individual's protected 
     health information as to the type, duration, or quality of 
     treatment the individual believes he or she should have been 
     provided; or
       (3) permit any deletions or alterations of the original 
     information.

     SEC. 213. NOTICE OF CONFIDENTIALITY PRACTICES.

       (a) Preparation of Written Notice.--A health care provider, 
     health plan, health oversight agency, public health 
     authority, employer, health or life insurer, health 
     researcher, school or university shall post or provide, in 
     writing and in a clear and conspicuous manner, notice of the 
     entity's confidentiality practices, that shall include--
       (1) a description of an individual's rights with respect to 
     protected health information;
       (2) the procedures established by the entity for the 
     exercise of the individual's rights; and
       (3) the right to obtain a copy of the notice of the 
     confidentiality practices required under this subtitle.
       (b) Model Notice.--The Secretary, in consultation with the 
     National Committee on Vital and Health Statistics and the 
     National Association of Insurance Commissioners, and after 
     notice and opportunity for public comment, shall develop and 
     disseminate model notices of confidentiality practices. Use 
     of the model notice shall serve as an absolute defense 
     against claims of receiving inappropriate notice.

                Subtitle B--Establishment of Safeguards

     SEC. 221. ESTABLISHMENT OF SAFEGUARDS.

       A health care provider, health plan, health oversight 
     agency, public health authority, employer, health or life 
     insurer, health researcher, law enforcement official, school 
     or university shall establish and maintain appropriate 
     administrative, technical, and physical safeguards to protect 
     the confidentiality, security, accuracy, and integrity of 
     protected health information created, received, obtained, 
     maintained, used, transmitted, or disposed of by such entity.

                  Subtitle C--Enforcement; Definitions

     SEC. 231. CIVIL PENALTY.

       (a) Violation.--A health care provider, health researcher, 
     health plan, health oversight agency, public health agency, 
     law enforcement agency, employer, health or life insurer, 
     school, or university, or the agent of any such individual or 
     entity, who the Secretary, in consultation with the Attorney 
     General, determines has substantially and materially failed 
     to comply with this Act shall, for a violation of this title, 
     be subject, in addition to any other penalties that may be 
     prescribed by law, to a civil penalty of not more than $500 
     for each such violation, but not to exceed $5,000 in the 
     aggregate for multiple violations.
       (b) Procedures for Imposition of Penalties.--Section 1128A 
     of the Social Security Act, other than subsections (a) and 
     (b) and the second sentence of subsection (f) of that 
     section, shall apply to the imposition of a civil, monetary, 
     or exclusionary penalty under this section in the same manner 
     as such provisions apply with respect to the imposition of a 
     penalty under section 1128A of such Act.

     SEC. 232. DEFINITIONS.

       In this title:
       (1) Agent.--The term ``agent'' means a person who 
     represents and acts for another under the contract or 
     relation of agency, or whose function is to bring about, 
     modify, affect, accept performance of, or terminate 
     contractual obligations between the principal and a third 
     person, including a contractor.
       (2) Disclose.--The term ``disclose'' means to release, 
     transfer, provide access to, or otherwise divulge protected 
     health information to any person other than the individual 
     who is the subject of such information. Such term includes 
     the initial disclosure and any subsequent redisclosures of 
     protected health information.
       (3) Employer.--The term ``employer'' has the meaning given 
     such term under section 3(5) of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1002(5)), except that 
     such term shall include only employers of 2 or more 
     employees.
       (4) Health care provider.--The term ``health care 
     provider'' means a person who, with respect to a specific 
     item of protected health information, receives, creates, 
     uses, maintains, or discloses the information while acting in 
     whole or in part in the capacity of--
       (A) a person who is licensed, certified, registered, or 
     otherwise authorized by Federal or State law to provide an 
     item or service that constitutes health care in the ordinary 
     course of business, or practice of a profession;
       (B) a Federal, State, or employer-sponsored program that 
     directly provides items or services that constitute health 
     care to beneficiaries; or
       (C) an officer, employee, or agent of a person described in 
     subparagraph (A) or (B).
       (5) Health or life insurer.--The term ``health or life 
     insurer'' means a health insurance issuer as defined in 
     section 2791 of the Public Health Service Act (42 U.S.C. 
     300gg-91) or a life insurance company as defined in section 
     816 of the Internal Revenue Code of 1986.
       (6) Health plan.--The term ``health plan'' means any health 
     insurance plan, including any hospital or medical service 
     plan, dental or other health service plan or health 
     maintenance organization plan, provider sponsored 
     organization, or other program providing or arranging for the 
     provision of health benefits, whether or not funded through 
     the purchase of insurance.
       (7) Person.--The term ``person'' means a government, 
     governmental subdivision,

[[Page S8496]]

     agency or authority; corporation; company; association; firm; 
     partnership; society; estate; trust; joint venture; 
     individual; individual representative; tribal government; and 
     any other legal entity.
       (8) Protected health information.--The term ``protected 
     health information'' means any information (including 
     demographic information) whether or not recorded in any form 
     or medium--
       (A) that relates to the past, present or future--
       (i) physical or mental health or condition of an individual 
     (including the condition or other attributes of individual 
     cells or their components);
       (ii) provision of health care to an individual; or
       (iii) payment for the provision of health care to an 
     individual;
       (B) that is created by a health care provider, health plan, 
     health researcher, health oversight agency, public health 
     authority, employer, law enforcement official, health or life 
     insurer, school or university; and
       (C) that is not nonidentifiable health information.
       (9) School or university.--The term ``school or 
     university'' means an institution or place for instruction or 
     education, including an elementary school, secondary school, 
     or institution of higher learning, a college, or an 
     assemblage of colleges united under one corporate 
     organization or government.
       (10) Secretary.--The term ``Secretary'' means the Secretary 
     of Health and Human Services.
       (11) Writing.--The term ``writing'' means writing in either 
     a paper-based or computer-based form, including electronic 
     signatures.

              TITLE III--GENETIC INFORMATION AND SERVICES

     SEC. 301. SHORT TITLE.

       This title may be cited as the ``Genetic Information 
     Nondiscrimination in Health Insurance Act of 1998''.

     SEC. 302. AMENDMENTS TO EMPLOYEE RETIREMENT INCOME SECURITY 
                   ACT OF 1974.

       (a) Prohibition of Health Discrimination on the Basis of 
     Genetic Information or Genetic Services.--
       (1) No enrollment restriction for genetic services.--
     Section 702(a)(1)(F) of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1182(a)(1)(F)) is amended by 
     inserting before the period the following: ``(including 
     information about a request for or receipt of genetic 
     services)''.
       (2) No discrimination in group premiums based on predictive 
     genetic information.--Subpart B of part 7 of subtitle B of 
     title I of the Employee Retirement Income Security Act of 
     1974 (29 U.S.C. 1185 et seq.) (as amended by section 111) is 
     further amended by adding at the end the following:

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

       ``A group health plan, or a health insurance issuer 
     offering group health insurance coverage in connection with a 
     group health plan, shall not adjust premium or contribution 
     amounts for a group on the basis of predictive genetic 
     information concerning an individual in the group or a family 
     member of the individual (including information about a 
     request for or receipt of genetic services).''.
       (3) Conforming amendment.--Section 702(b) of the Employee 
     Retirement Income Security Act of 1974 (29 U.S.C. 1182(b)) is 
     amended by adding at the end the following:
       ``(3) Reference to related provision.--For a provision 
     prohibiting the adjustment of premium or contribution amounts 
     for a group under a group health plan on the basis of 
     predictive genetic information (including information about a 
     request for or receipt of genetic services), see section 
     714.''.
       (b) Limitation on Collection of Predictive Genetic 
     Information.--Section 702 of the Employee Retirement Income 
     Security Act of 1974 (29 U.S.C. 1182) is amended by adding at 
     the end the following:
       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     group health plan, or a health insurance issuer offering 
     health insurance coverage in connection with a group health 
     plan, shall not request or require predictive genetic 
     information concerning an individual or a family member of 
     the individual (including information about a request for or 
     receipt of genetic services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) In general.--Notwithstanding paragraph (1), a group 
     health plan or health insurance issuer that provides health 
     care items and services to an individual or dependent may 
     request (but may not require) that such individual or 
     dependent disclose, or authorize the collection or disclosure 
     of, predictive genetic information for purposes of diagnosis, 
     treatment, or payment relating to the provision of health 
     care items and services to such individual or dependent.
       ``(B) Notice of confidentiality practices and description 
     of safeguards.--As a part of a request under subparagraph 
     (A), the group health plan or health insurance issuer shall 
     provide to the individual or dependent a description of the 
     procedures in place to safeguard the confidentiality, as 
     described in sections 213 and 221 of the Patients' Bill of 
     Rights Act, of such individually identifiable information.''.
       (c) Definitions.--Section 733(d) of the Employee Retirement 
     Income Security Act of 1974 (29 U.S.C. 1191b(d)) is amended 
     by adding at the end the following:
       ``(5) Family member.--The term `family member' means with 
     respect to an individual--
       ``(A) the spouse of the individual;
       ``(B) a dependent child of the individual, including a 
     child who is born to or placed for adoption with the 
     individual; and
       ``(C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       ``(6) Genetic information.--The term `genetic information' 
     means information about genes, gene products, or inherited 
     characteristics that may derive from an individual or a 
     family member (including information about a request for or 
     receipt of genetic services).
       ``(7) Genetic services.--The term `genetic services' means 
     health services provided to obtain, assess, or interpret 
     genetic information for diagnostic and therapeutic purposes, 
     and for genetic education and counseling.
       ``(8) Predictive genetic information.--
       ``(A) In general.--The term `predictive genetic 
     information' means--
       ``(i) information about an individual's genetic tests which 
     are associated with a statistically significant increased 
     risk of developing a disease or disorder;
       ``(ii) information about genetic tests of family members of 
     the individual; or
       ``(iii) information about the occurrence of a disease or 
     disorder in family members that predicts a statistically 
     significant increased risk of a disease or disorder in the 
     individual.
       ``(B) Exceptions.--The term `predictive genetic 
     information' shall not include--
       ``(i) information about the sex or age of the individual;
       ``(ii) information derived from routine physical tests, 
     such as the chemical, blood, or urine analyses of the 
     individual, unless such analyses are genetic tests; and
       ``(iii) information about physical exams of the individual 
     and other information relevant to determining the current 
     health status of the individual so long as such information 
     does not include information described in clauses (i), (ii), 
     or (iii) of subparagraph (A).
       ``(9) Genetic test.--The term `genetic test' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites, in order to detect disease-related 
     genotypes, mutations, phenotypes, or karyotypes.''.
       (d) Effective Date.--Except as provided in this section, 
     this section and the amendments made by this section shall 
     apply with respect to group health plans for plan years 
     beginning 1 year after the date of the enactment of this Act.

     SEC. 303. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

       (a) Amendments Relating to the Group Market.--
       (1) Prohibition of health discrimination on the basis of 
     genetic information in the group market.--
       (A) In general.--Subpart 2 of part A of title XXVII of the 
     Public Health Service Act (42 U.S.C. 300gg-4 et seq.) is 
     amended by adding at the end the following:

     ``SEC. 2706. PROHIBITING PREMIUM DISCRIMINATION AGAINST 
                   GROUPS ON THE BASIS OF PREDICTIVE GENETIC 
                   INFORMATION IN THE GROUP MARKET.

       ``A group health plan, or a health insurance issuer 
     offering group health insurance coverage in connection with a 
     group health plan shall not adjust premium or contribution 
     amounts for a group on the basis of predictive genetic 
     information concerning an individual in the group or a family 
     member of the individual (including information about a 
     request for or receipt of genetic services).''.
       (B) Conforming amendment.--Section 2702(b) of the Public 
     Health Service Act (42 U.S.C. 300gg-1(b)) is amended by 
     adding at the end the following:
       ``(3) Reference to related provision.--For a provision 
     prohibiting the adjustment of premium or contribution amounts 
     for a group under a group health plan on the basis of 
     predictive genetic information (including information about a 
     request for or receipt of genetic services), see section 
     2706.''.
       (C) Limitation on collection and disclosure of predictive 
     genetic information.--Section 2702 of the Public Health 
     Service Act (42 U.S.C. 300gg-1) is amended by adding at the 
     end the following:
       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     group health plan, or a health insurance issuer offering 
     health insurance coverage in connection with a group health 
     plan, shall not request or require predictive genetic 
     information concerning an individual or a family member of 
     the individual (including information about a request for or 
     receipt of genetic services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) In general.--Notwithstanding paragraph (1), a group 
     health plan or health insurance issuer that provides health 
     care items and services to an individual or dependent may 
     request (but may not require) that such individual or 
     dependent disclose,

[[Page S8497]]

     or authorize the collection or disclosure of, predictive 
     genetic information for purposes of diagnosis, treatment, or 
     payment relating to the provision of health care items and 
     services to such individual or dependent.
       ``(B) Notice of confidentiality practices and description 
     of safeguards.--As a part of a request under subparagraph 
     (A), the group health plan or health insurance issuer shall 
     provide to the individual or dependent a description of the 
     procedures in place to safeguard the confidentiality, as 
     described in sections 213 and 221 of the Patients' Bill of 
     Rights Act, of such individually identifiable information.''.
       (2) Definitions.--Section 2791(d) of the Public Health 
     Service Act (42 U.S.C. 300gg-91(d)) is amended by adding at 
     the end the following:
       ``(15) Family member.--The term `family member' means, with 
     respect to an individual--
       ``(A) the spouse of the individual;
       ``(B) a dependent child of the individual, including a 
     child who is born to or placed for adoption with the 
     individual; and
       ``(C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       ``(16) Genetic information.--The term `genetic information' 
     means information about genes, gene products, or inherited 
     characteristics that may derive from an individual or a 
     family member.
       ``(17) Genetic services.--The term `genetic services' means 
     health services provided to obtain, assess, or interpret 
     genetic information for diagnostic and therapeutic purposes, 
     and for genetic education and counseling.
       ``(18) Predictive genetic information.--
       ``(A) In general.--The term `predictive genetic 
     information' means--
       ``(i) information about an individual's genetic tests which 
     is associated with a statistically significant increased risk 
     of developing a disease or disorder;
       ``(ii) information about genetic tests of family members of 
     the individual; or
       ``(iii) information about the occurrence of a disease or 
     disorder in family members that predicts a statistically 
     significant increased risk of a disease or disorder in the 
     individual.
       ``(B) Exceptions.--The term `predictive genetic 
     information' shall not include--
       ``(i) information about the sex or age of the individual;
       ``(ii) information derived from routine physical tests, 
     such as the chemical, blood, or urine analyses of the 
     individual, unless such analyses are genetic tests; and
       ``(iii) information about physical exams of the individual 
     and other information relevant to determining the current 
     health status of the individual so long as such information 
     does not include information described in clauses (i), (ii), 
     or (iii) of subparagraph (A).
       ``(19) Genetic test.--The term `genetic test' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites, in order to detect disease-related 
     genotypes, mutations, phenotypes, or karyotypes.''.
       (b) Amendment Relating to the Individual Market.--The first 
     subpart 3 of part B of title XXVII of the Public Health 
     Service Act (42 U.S.C. 300gg-11 et seq.) (relating to other 
     requirements) is amended--
       (1) by redesignating such subpart as subpart II; and
       (2) by adding at the end the following:

     ``SEC. 2752. PROHIBITION OF HEALTH DISCRIMINATION ON THE 
                   BASIS OF PREDICTIVE GENETIC INFORMATION.

       ``(a) Prohibition on Predictive Genetic Information as a 
     Condition of Eligibility.--A health insurance issuer offering 
     health insurance coverage in the individual market may not 
     use predictive genetic information as a condition of 
     eligibility of an individual to enroll in individual health 
     insurance coverage (including information about a request for 
     or receipt of genetic services).
       ``(b) Prohibition on Predictive Genetic Information in 
     Setting Premium Rates.--A health insurance issuer offering 
     health insurance coverage in the individual market shall not 
     adjust premium rates for individuals on the basis of 
     predictive genetic information concerning such an enrollee or 
     a family member of the enrollee (including information about 
     a request for or receipt of genetic services).
       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     health insurance issuer offering health insurance coverage in 
     the individual market shall not request or require predictive 
     genetic information concerning an individual or a family 
     member of the individual (including information about a 
     request for or receipt of genetic services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) in general.--Notwithstanding paragraph (1), a health 
     insurance issuer that provides health care items and services 
     to an individual or dependent may request (but may not 
     require) that such individual or dependent disclose, or 
     authorize the collection or disclosure of, predictive genetic 
     information for purposes of diagnosis, treatment, or payment 
     relating to the provision of health care items and services 
     to such individual or dependent.
       ``(B) Notice of confidentiality practices and description 
     of safeguards.--As a part of a request under subparagraph 
     (A), the health insurance issuer shall provide to the 
     individual or dependent a description of the procedures in 
     place to safeguard the confidentiality, as described in 
     sections 213 and 221 of the Patients' Bill of Rights Act, of 
     such individually identifiable information.''.
       (c) Effective Date.--The amendments made by this section 
     shall apply with respect to--
       (1) group health plans, and health insurance coverage 
     offered in connection with group health plans, for plan years 
     beginning after 1 year after the date of enactment of this 
     Act; and
       (2) health insurance coverage offered, sold, issued, 
     renewed, in effect, or operated in the individual market 
     after 1 year after the date of enactment of this Act.

     SEC. 304. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.

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

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

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

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

       (b) Limitation on Collection of Predictive Genetic 
     Information.--Section 9802 of the Internal Revenue Code of 
     1986 is amended by adding at the end the following:
       ``(c) Collection of Predictive Genetic Information.--
       ``(1) Limitation on requesting or requiring predictive 
     genetic information.--Except as provided in paragraph (2), a 
     group health plan, or a health insurance issuer offering 
     health insurance coverage in connection with a group health 
     plan, shall not request or require predictive genetic 
     information concerning an individual or a family member of 
     the individual (including information about a request for or 
     receipt of genetic services).
       ``(2) Information needed for diagnosis, treatment, or 
     payment.--
       ``(A) In general.--Notwithstanding paragraph (1), a group 
     health plan or health insurance issuer that provides health 
     care items and services to an individual or dependent may 
     request (but may not require) that such individual or 
     dependent disclose, or authorize the collection or disclosure 
     of, predictive genetic information for purposes of diagnosis, 
     treatment, or payment relating to the provision of health 
     care items and services to such individual or dependent.
       ``(B) Notice of confidentiality practices; description of 
     safeguards.--As a part of a request under subparagraph (A), 
     the group health plan or health insurance issuer shall 
     provide to the individual or dependent a description of the 
     procedures in place to safeguard the confidentiality, as 
     described in sections 213 and 221 of the Patients' Bill of 
     Rights Act, of such individually identifiable information.''.
       (c) Definitions.--Section 9832(d) of the Internal Revenue 
     Code of 1986 is amended by adding at the end the following:
       ``(6) Family member.--The term `family member' means, with 
     respect to an individual--
       ``(A) the spouse of the individual;
       ``(B) a dependent child of the individual, including a 
     child who is born to or placed for adoption with the 
     individual; and
       ``(C) all other individuals related by blood to the 
     individual or the spouse or child described in subparagraph 
     (A) or (B).
       ``(7) Genetic information.--The term `genetic information' 
     means information about genes, gene products, or inherited 
     characteristics that may derive from an individual or a 
     family member.
       ``(8) Genetic services.--The term `genetic services' means 
     health services provided to obtain, assess, or interpret 
     genetic information for diagnostic and therapeutic purposes, 
     and for genetic education and counseling.
       ``(9) Predictive genetic information.--
       ``(A) In general.--The term `predictive genetic 
     information' means--
       ``(i) information about an individual's genetic tests which 
     is associated with a statistically significant increased risk 
     of developing a disease or disorder;
       ``(ii) information about genetic tests of family members of 
     the individual; or

[[Page S8498]]

       ``(iii) information about the occurrence of a disease or 
     disorder in family members that predicts a statistically 
     significant increased risk of a disease or disorder in the 
     individual.
       ``(B) Exceptions.--The term `predictive genetic 
     information' shall not include--
       ``(i) information about the sex or age of the individual;
       ``(ii) information derived from routine physical tests, 
     such as the chemical, blood, or urine analyses of the 
     individual, unless such analyses are genetic tests; and
       ``(iii) information about physical exams of the individual 
     and other information relevant to determining the current 
     health status of the individual so long as such information 
     does not include information described in clauses (i), (ii), 
     or (iii) of subparagraph (A).
       ``(10) Genetic test.--The term `genetic test' means the 
     analysis of human DNA, RNA, chromosomes, proteins, and 
     certain metabolites, in order to detect disease-related 
     genotypes, mutations, phenotypes, or karyotypes.''.
       (d) Effective Date.--Except as provided in this section, 
     this section and the amendments made by this section shall 
     apply with respect to group health plans for plan years 
     beginning after 1 year after the date of the enactment of 
     this Act.

                 TITLE IV--HEALTHCARE QUALITY RESEARCH

     SEC. 401. SHORT TITLE.

       This title may be cited as the ``Healthcare Quality 
     Research Act of 1998''.

     SEC. 402. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

       Title IX of the Public Health Service Act (42 U.S.C. 299 et 
     seq.) is amended to read as follows:

           ``TITLE IX--AGENCY FOR HEALTHCARE QUALITY RESEARCH

               ``PART A--ESTABLISHMENT AND GENERAL DUTIES

     ``SEC. 901. MISSION AND DUTIES.

       ``(a) In General.--There is established within the Public 
     Health Service an agency to be known as the Agency for 
     Healthcare Quality Research. In carrying out this subsection, 
     the Secretary shall redesignate the Agency for Health Care 
     Policy and Research as the Agency for Healthcare Quality 
     Research.
       ``(b) Mission.--The purpose of the Agency is to enhance the 
     quality, appropriateness, and effectiveness of healthcare 
     services, and access to such services, through the 
     establishment of a broad base of scientific research and 
     through the promotion of improvements in clinical practice, 
     including the prevention of diseases and other health 
     conditions. The Agency shall promote healthcare quality 
     improvement by--
       ``(1) conducting and supporting research that develops and 
     presents scientific evidence regarding all aspects of 
     healthcare, including--
       ``(A) the development and assessment of methods for the 
     purposes of enhancing patient participation in their own care 
     and for facilitating shared patient-physician decision-
     making;
       ``(B) the outcomes, effectiveness, and cost-effectiveness 
     of healthcare practices, including preventive measures and 
     primary care;
       ``(C) existing and innovative technologies;
       ``(D) the costs and utilization of, and access to 
     healthcare;
       ``(E) the ways in which healthcare services are organized, 
     delivered, and financed and the interaction and impact of 
     these factors on the quality of patient care;
       ``(F) methods for measuring quality and strategies for 
     improving quality; and
       ``(G) ways in which patients, consumers, and practitioners 
     acquire new information about best practices and health 
     benefits, and the determinants of their use of this 
     information;
       ``(2) synthesizing and disseminating available scientific 
     evidence for use by patients, consumers, practitioners, 
     providers, purchasers, policy makers, and educators; and
       ``(3) advancing private and public efforts to improve 
     healthcare quality.
       ``(c) Requirements With Respect to Rural Areas and Priority 
     Populations.--In carrying out subsection (b), the Director 
     shall undertake and support research, demonstration projects, 
     and evaluations with respect to--
       ``(1) the delivery of health services in rural areas 
     (including frontier areas);
       ``(2) health services for low-income groups, and minority 
     groups;
       ``(3) the health of children;
       ``(4) the elderly; and
       ``(5) people with special healthcare needs, including 
     chronic care and end-of-life healthcare.
       ``(d) Appointment of Director.--There shall be at the head 
     of the Agency an official to be known as the Director for 
     Healthcare Quality Research. The Director shall be appointed 
     by the Secretary. The Secretary, acting through the Director, 
     shall carry out the authorities and duties established in 
     this title.

     ``SEC. 902. GENERAL AUTHORITIES.

       ``(a) In General.--In carrying out section 901(b), the 
     Director shall support demonstration projects, conduct and 
     support research, evaluations, training, research networks, 
     multi-disciplinary centers, technical assistance, and the 
     dissemination of information, on healthcare, and on systems 
     for the delivery of such care, including activities with 
     respect to--
       ``(1) the quality, effectiveness, efficiency, 
     appropriateness and value of healthcare services;
       ``(2) quality measurement and improvement;
       ``(3) the outcomes, cost, cost-effectiveness, and use of 
     healthcare services and access to such services;
       ``(4) clinical practice, including primary care and 
     practice-oriented research;
       ``(5) healthcare technologies, facilities, and equipment;
       ``(6) healthcare costs, productivity, and market forces;
       ``(7) health promotion and disease prevention, including 
     clinical preventive services;
       ``(8) health statistics, surveys, database development, and 
     epidemiology; and
       ``(9) medical liability.
       ``(b) Health Services Training Grants.--The Director may 
     provide training grants in the field of health services 
     research related to activities authorized under subsection 
     (a), to include pre- and post-doctoral fellowships and 
     training programs, young investigator awards, and other 
     programs and activities as appropriate. In carrying out this 
     subsection, the Director shall make use of funds made 
     available under section 478.
       ``(c) Multidisciplinary Centers.--The Director may provide 
     financial assistance to assist in meeting the costs of 
     planning and establishing new centers, and operating existing 
     and new centers, for multidisciplinary health services 
     research, demonstration projects, evaluations, training, and 
     policy analysis with respect to the matters referred to in 
     subsection (a).
       ``(d) Relation to Certain Authorities Regarding Social 
     Security.--Activities authorized in this section may include, 
     and shall be appropriately coordinated with experiments, 
     demonstration projects, and other related activities 
     authorized by the Social Security Act and the Social Security 
     Amendments of 1967. Activities under subsection (a)(2) of 
     this section that affect the programs under titles XVIII and 
     XIX of the Social Security Act shall be carried out 
     consistent with section 1142 of such Act.
       ``(e) Disclaimer.--Nothing in this title shall be construed 
     to imply that the Agency's role is to mandate national 
     standards of clinical practice or quality healthcare 
     standards. Recommendations resulting from projects funded and 
     published by the Agency shall include a corresponding 
     disclaimer.
       ``(f) Rule of Construction.--Nothing in this section shall 
     be construed to imply that quality measurement is a science 
     of uniform national standards. In research and quality 
     improvement activities, the Agency shall consider a wide 
     range of choices, providers, healthcare delivery systems, and 
     individual preferences.

               ``PART B--HEALTHCARE IMPROVEMENT RESEARCH

     ``SEC. 911. HEALTHCARE OUTCOME IMPROVEMENT RESEARCH.

       ``(a) Evidence Rating Systems.--In collaboration with 
     experts from the public and private sector, the Agency shall 
     identify and disseminate methods or systems used to assess 
     healthcare research results, particularly to rate the 
     strength of the scientific evidence behind healthcare 
     practice and technology recommendations in the research 
     literature. The Agency shall make methods or systems for 
     evidence rating widely available. Agency publications 
     containing healthcare recommendations shall indicate the 
     level of substantiating evidence using such methods or 
     systems.
       ``(b) Healthcare Improvement Research Centers and Provider-
     Based Research Networks.--
       ``(1) In general.--In order to address the full continuum 
     of care and outcomes research, to link research to practice 
     improvement, and to speed the dissemination of research 
     findings to community practice settings, the Agency shall 
     employ research strategies and mechanisms that will link 
     research directly with clinical practice in geographically 
     diverse locations throughout the United States, including--
       ``(A) Healthcare Improvement Research Centers that combine 
     demonstrated multidisciplinary expertise in outcomes or 
     quality improvement research with linkages to relevant sites 
     of care;
       ``(B) Practice-based Research Networks, including plan, 
     facility, or delivery system sites of care (especially 
     primary care), that can evaluate and promote quality 
     improvement; and
       ``(C) other innovative mechanisms or strategies.
       ``(2) Requirements.--The Director is authorized to 
     establish the requirements for entities applying for grants 
     under this subsection.
       ``(c) Expansion of the Health Services Research 
     Workforce.--
       ``(1) Grants.--The Agency shall, through the awarding of 
     grants, support eligible entities at geographically diverse 
     locations throughout the United States to enable such 
     entities to carry out research training programs that are 
     dedicated to health services research training at the 
     doctoral, post-doctoral, and junior faculty levels.
       ``(2) Requirements.--In developing priorities for the 
     allocation of training funds under this subsection, the 
     Director shall take into consideration shortages in the 
     number of trained researchers addressing the priority 
     populations.

[[Page S8499]]

     ``SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE 
                   ORGANIZATION AND DELIVERY.

       ``(a) Support for Efforts To Develop Information on 
     Quality.--
       ``(1) Scientific and technical support.--In its role as the 
     principal agency for healthcare quality research, the Agency 
     shall provide scientific and technical support for private 
     and public efforts to improve healthcare quality, including 
     accrediting organizations.
       ``(2) Role of the agency.--With respect to paragraph (1), 
     the role of the Agency shall include--
       ``(A) the identification and assessment of methods for the 
     evaluation of the health of enrollees in health plans by type 
     of plan, provider, and provider arrangements;
       ``(B) the ongoing development, testing, and dissemination 
     of quality measures, including measures of health and 
     functional outcomes, that take into account appropriate 
     variations in individual preferences;
       ``(C) the compilation and dissemination of healthcare 
     quality measures developed in the private and public sector;
       ``(D) assistance in the development of improved healthcare 
     information systems;
       ``(E) the development of survey tools for the purpose of 
     measuring participant and beneficiary assessments of their 
     healthcare; and
       ``(F) the integration of information on quality into 
     purchaser and consumer decision-making processes.
       ``(b) Demonstration Program Regarding Centers for Education 
     and Research on Therapeutics.--
       ``(1) In general.--The Secretary, acting through the 
     Director and in consultation with the Commissioner of Food 
     and Drugs, shall establish a demonstration program for the 
     purpose of making one or more grants for the establishment 
     and operation of one or more centers to carry out the 
     activities specified in paragraph (2).
       ``(2) Required activities.--The activities referred to in 
     this paragraph are the following:
       ``(A) The conduct of state-of-the-art clinical research for 
     the following purposes:
       ``(i) To increase awareness of--

       ``(I) new uses of drugs, biological products, and devices;
       ``(II) ways to improve the effective use of drugs, 
     biological products, and devices; and
       ``(III) risks of new uses and risks of combinations of 
     drugs and biological products.

       ``(ii) To provide objective clinical information to the 
     following individuals and entities:

       ``(I) Healthcare practitioners and other providers of 
     Healthcare goods or services.
       ``(II) Pharmacy benefit managers and purchasers.
       ``(III) Health maintenance organizations and other managed 
     healthcare organizations.
       ``(IV) Healthcare insurers and governmental agencies.
       ``(V) Patients and consumers.

       ``(iii) To improve the quality of healthcare while reducing 
     the cost of Healthcare through--

       ``(I) the appropriate use of drugs, biological products, or 
     devices; and
       ``(II) the prevention of adverse effects of drugs, 
     biological products, and devices and the consequences of such 
     effects, such as unnecessary hospitalizations.

       ``(B) The conduct of research on the comparative 
     effectiveness, cost-effectiveness, and safety of drugs, 
     biological products, and devices.
       ``(C) Such other activities as the Secretary determines to 
     be appropriate, except that a grant may not be expended to 
     assist the Secretary in the review of new drugs.
       ``(3) Application for grant.--A grant under paragraph (1) 
     may be made only if an application for the grant is submitted 
     to the Secretary and the application is in such form, is made 
     in such manner, and contains such agreements, assurances, and 
     information as the Secretary determines to be necessary to 
     carry out this section.
       ``(4) Peer review.--A grant under paragraph (1) may be made 
     only if the application for the grant has undergone 
     appropriate technical and scientific peer review.
       ``(c) Reducing Errors in Medicine.--The Director shall 
     conduct and support research and build private-public 
     partnerships to--
       ``(1) identify the causes of preventable healthcare errors 
     and patient injury in healthcare delivery systems;
       ``(2) develop, demonstrate, and evaluate strategies for 
     reducing errors and improving patient safety; and
       ``(3) promote the implementation of effective strategies 
     throughout the healthcare industry.

     ``SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.

       ``(a) In General.--In carrying out 902(a), the Director 
     shall--
       ``(1) collect data from a nationally representative sample 
     of the population on the cost and use of healthcare, 
     including the types of healthcare services Americans use, 
     their access to healthcare services, frequency of use, how 
     much is paid for the services used, the source of those 
     payments, the types and costs of private health insurance, 
     access, satisfaction, and quality of care for the general 
     population and also for children, uninsured persons, poor and 
     near-poor individuals, and persons with special healthcare 
     needs, including end-of-life healthcare;
       ``(2) develop databases and tools that enable States to 
     track the quality, access, and use of healthcare services 
     provided to their residents; and
       ``(3) enter into agreements with public or private entities 
     to use, link, or acquire databases for research authorized 
     under this title.
       ``(b) Quality and Outcomes Information.--
       ``(1) In general.--To enhance the understanding of the 
     quality of care, the determinants of health outcomes and 
     functional status, the needs of special populations as well 
     as an understanding of these changes over time, their 
     relationship to healthcare access and use, and to monitor the 
     overall national impact of Federal and State policy changes 
     on healthcare, the Director, beginning in fiscal year 2000, 
     shall ensure that the survey conducted under subsection 
     (a)(1) will--
       ``(A) provide information on the quality of care and 
     patient outcomes for frequently occurring clinical conditions 
     for a nationally representative sample of the population; and
       ``(B) provide reliable national estimates for children and 
     persons with special healthcare needs through the use of 
     supplements or periodic expansions of the survey.
       ``(2) Annual report.--Beginning in fiscal year 2002, the 
     Secretary, acting through the Director, shall submit to 
     Congress an annual report on national trends in the quality 
     of healthcare provided to the American people.

     ``SEC. 914. INFORMATION SYSTEMS FOR HEALTHCARE IMPROVEMENT.

       ``In order to foster a range of innovative approaches to 
     the management and communication of health information, the 
     Agency shall support research to evaluate and initiatives to 
     advance--
       ``(1) the use of information systems for the study of 
     healthcare quality, including the generation of both 
     individual provider and plan-level comparative performance 
     measures;
       ``(2) training for healthcare practitioners and researchers 
     in the use of information systems;
       ``(3) the creation of effective linkages between various 
     sources of health information, including the development of 
     information networks;
       ``(4) the delivery and coordination of evidence-based 
     healthcare services, using real-time decision-support 
     programs;
       ``(5) the structure, content, definition, and coding of 
     health information data and medical vocabularies and shall 
     consult with other Federal entities;
       ``(6) the evaluation and use of computer-based health 
     records in outpatient and inpatient settings as a personal 
     health record for individual health assessment and 
     maintenance, and for monitoring public health and outcomes of 
     care within populations; and
       ``(7) the protection of individually identifiable 
     information in health services research and healthcare 
     quality improvement.

     ``SEC. 915. RESEARCH SUPPORTING PRIMARY CARE DELIVERY AND 
                   ACCESS IN UNDERSERVED AREAS.

       ``(a) Preventive Services Task Force.--
       ``(1) Purpose.--The Agency shall provide ongoing 
     administrative, research, and technical support for the 
     operation of the Preventive Services Task Force. The Agency 
     shall coordinate and support the dissemination of the 
     Preventive Services Task Force recommendations.
       ``(2) Operation.--The Preventive Services Task Force shall 
     review the scientific evidence related to the effectiveness, 
     appropriateness, and cost-effectiveness of clinical 
     preventive services for the purpose of developing 
     recommendations, and updating previous recommendations, 
     regarding their usefulness in daily clinical practice. In 
     carrying out its responsibilities under paragraph (1), the 
     Task Force shall not be subject to the provisions of Appendix 
     2 of title 5, United States Code.
       ``(b) Primary Care Delivery Research.--
       ``(1) In general.--There is established within the Agency a 
     Center for Primary Care Delivery Research (referred to in 
     this subsection as the `Center') that shall serve as the 
     principal source of funding for primary care delivery 
     research in the Department of Health and Human Services. For 
     purposes of this paragraph, primary care delivery research 
     focuses on the first contact when illness or health concerns 
     arise, the diagnosis, treatment or referral to specialty 
     care, preventive care, and the relationship between the 
     clinician and the patient in the context of the family and 
     community.
       ``(2) Research.--In carrying out this section, the Center 
     shall conduct and support research on--
       ``(A) the nature and characteristics of primary care 
     delivery practice;
       ``(B) producing evidence for the management of commonly 
     occurring clinical problems;
       ``(C) the management of undifferentiated clinical problems;
       ``(D) the continuity and coordination of health services; 
     and
       ``(E) the application and impact of telemedicine and other 
     distance technologies.
       ``(3) Demonstration.--The Agency shall support 
     demonstrations into the use of new information tools aimed at 
     improving shared decision-making between patients and their 
     care-givers.

     ``SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVATION.

       ``(a) In General.--The Director shall promote innovation in 
     evidence-based clinical practice and healthcare technologies 
     by--
       ``(1) conducting and supporting research on the 
     development, diffusion, and use of healthcare technology;

[[Page S8500]]

       ``(2) developing, evaluating, and disseminating 
     methodologies for healthcare practice and technology 
     assessment;
       ``(3) conducting intramural and supporting extramural 
     assessments of existing and new healthcare practices and 
     technologies;
       ``(4) promoting education, training, and providing 
     technical assistance in the use of healthcare practice and 
     healthcare technology assessment methodologies and results; 
     and
       ``(5) working with the National Library of Medicine and the 
     public and private sector to develop an electronic 
     clearinghouse of currently available assessments and those in 
     progress.
       ``(b) Specification of Process.--
       ``(1) In general.--Not later than June 1, 1999, the 
     Director shall develop and publish a description of the 
     methods used by the Agency and its contractors for practice 
     and technology assessment.
       ``(2) Consultations.--In carrying out this subsection, the 
     Director shall cooperate and consult with the Administrator 
     of the Health Care Financing Administration, the Director of 
     the National Institutes of Health, the Commissioner of Food 
     and Drugs, and the heads of any other interested Federal 
     department or agency, professional societies, and other 
     private and public entities.
       ``(3) Methodology.--The methods employed in practice and 
     technology assessments under paragraph (1) shall consider--
       ``(A) safety, efficacy, and effectiveness;
       ``(B) legal, social, and ethical implications;
       ``(C) costs, benefits, and cost-effectiveness;
       ``(D) comparisons to alternative technologies and 
     practices; and
       ``(E) requirements of Food and Drug Administration approval 
     to avoid duplication.
       ``(c) Specific Assessments.--
       ``(1) In general.--The Director shall conduct and support 
     specific assessments of healthcare technologies and 
     practices.
       ``(2) Grants and contracts.--The Director may make grants 
     to, or enter into cooperative agreements or contracts with, 
     entities described in paragraph (3) for the establishment of 
     collaborative arrangements for the purpose of conducting 
     assessments of experimental, emerging, existing, or 
     potentially outmoded healthcare technologies, and for related 
     activities.
       ``(3) Eligible entities.--An entity described in this 
     paragraph is an entity that is determined to be appropriate 
     by the Director, including academic medical centers, research 
     institutions, professional organizations, third party payers, 
     other governmental agencies, and consortia of appropriate 
     research entities established for the purpose of conducting 
     technology assessments.

     ``SEC. 917. COORDINATION OF FEDERAL GOVERNMENT QUALITY 
                   IMPROVEMENT EFFORTS.

       ``(a) Requirement.--
       ``(1) In general.--The Secretary, acting through the 
     Director, shall coordinate all research, evaluations, and 
     demonstrations related to health services research and 
     quality measurement and improvement activities undertaken and 
     supported by the Federal Government.
       ``(2) Specific activities.--The Director, in collaboration 
     with the appropriate Federal officials representing all 
     concerned executive agencies and departments, shall develop 
     and manage a process to--
       ``(A) improve interagency coordination, priority setting, 
     and the use and sharing of research findings and data 
     pertaining to Federal quality improvement programs and health 
     services research;
       ``(B) strengthen the research information infrastructure, 
     including databases, pertaining to Federal health services 
     research and healthcare quality improvement initiatives;
       ``(C) set specific goals for participating agencies and 
     departments to further health services research and 
     healthcare quality improvement; and
       ``(D) strengthen the management of Federal healthcare 
     quality improvement programs.
       ``(b) Study by the Institute of Medicine.--
       ``(1) In general.--To provide the Department of Health and 
     Human Services with independent, expert advice in redesigning 
     its quality oversight functions, and pertinent research 
     programs, the Secretary shall enter into a contract with the 
     Institute of Medicine--
       ``(A) to describe and evaluate current quality improvement 
     research and monitoring processes through--
       ``(i) an overview of pertinent health services research 
     activities and quality improvement efforts with particular 
     attention paid to those performed by the peer review 
     organizations;
       ``(ii) an analysis of the various partnership activities 
     that the Department of Health and Human Services has pursued 
     with private sector accreditation and other quality 
     measurement organizations;
       ``(iii) the exploration of programmatic areas where 
     partnership activities could be pursued to improve quality 
     oversight of the medicare and medicaid programs under titles 
     XVIII and XIX of the Social Security Act; and
       ``(iv) an identification of opportunities for enhancing 
     health system efficiency through simplification and reduction 
     in redundancy of public and private sector quality 
     improvement efforts; and
       ``(B) to identify options and make recommendations to 
     improve the efficiency and effectiveness of such quality 
     improvement programs and to optimize public/private sector 
     accreditation bodies through--
       ``(i) the improved coordination of activities across the 
     medicare and medicaid programs under titles XVIII and XIX of 
     the Social Security Act and various health services research 
     programs;
       ``(ii) greater consistency and standardization of oversight 
     activities across traditional fee-for-service and managed 
     care components of these programs;
       ``(iii) the strengthening of patient choice and 
     participation by incorporating state-of-the-art quality 
     monitoring tools and making information on quality available; 
     and
       ``(iv) the enhancement of the most effective programs, 
     consolidation as appropriate, and elimination of duplicative 
     activities within various federal agencies.
       ``(2) Requirements.--
       ``(A) In general.--The Secretary shall enter into a 
     contract with the Institute of Medicine for the preparation--
       ``(i) not later than 12 months after the date of enactment 
     of this title, of a report providing an overview of the 
     quality improvement programs of the Department of Health and 
     Human Services for the medicare, medicaid, and CHIP programs 
     under titles XVIII, XIX, and XXI of the Social Security Act; 
     and
       ``(ii) not later than 24 months after the date of enactment 
     of this title, of a final report containing recommendations 
     for a comprehensive system and public-private partnerships 
     for healthcare quality improvement.
       ``(B) Reports.--The Secretary shall submit the reports 
     described in subparagraph (A) to the Committee on Finance and 
     the Committee on Labor and Human Resources of the Senate and 
     the Committee on Ways and Means and the Committee on Commerce 
     of the House of Representatives.

          ``PART C--FOUNDATION FOR HEALTHCARE QUALITY RESEARCH

     ``SEC. 921. FOUNDATION FOR HEALTHCARE QUALITY RESEARCH.

       ``(a) In General.--The Secretary shall, acting through the 
     Director of the Agency for Healthcare Quality Research, 
     establish a nonprofit corporation to be known as the 
     Foundation for Healthcare Research (hereafter in this section 
     referred to as the `Foundation'). The Foundation shall not be 
     an agency or instrumentality of the United States Government.
       ``(b) Purpose of Foundation.--The purpose of the Foundation 
     shall be to--
       ``(1) support the Agency for Healthcare Quality Research in 
     its mission;
       ``(2) foster public-private partnerships to support the 
     programs and activities of the Agency;
       ``(3) advance collaboration with healthcare researchers 
     from universities, industry, and nonprofit organizations; and
       ``(4) develop linkages with users of healthcare and quality 
     research, including patients, consumers, practitioners and 
     other healthcare providers, health plans and insurers, large 
     private or public sector purchasers of healthcare, healthcare 
     policy makers, and healthcare educators.
       ``(c) Certain Activities of Foundation.--In carrying out 
     subsection (b), the Foundation may solicit and accept gifts, 
     grants, and other donations, establish accounts, and invest 
     and expend funds in support of a broad range of research, 
     training, dissemination, and other activities with respect to 
     the purpose described in such subsection. In addition, the 
     Foundation is authorized to support the following:
       ``(1) A program to provide and administer endowed positions 
     that are associated with the research program of the Agency 
     for Healthcare Quality Research. Such endowments may be 
     expended for the compensation of individuals holding the 
     positions, for staff, equipment, quarters, travel, and other 
     expenditures that are appropriate in supporting the endowed 
     positions.
       ``(2) A program to provide and administer fellowships and 
     grants to research personnel in order to work and study in 
     association with the Agency for Healthcare Quality Research. 
     Such fellowships and grants may include stipends, travel, 
     health insurance benefits, and other appropriate expenses. 
     The recipients of fellowships shall be selected by the donors 
     and the Foundation upon the recommendation of the Agency for 
     Healthcare Quality Research, and shall be subject to the 
     agreement of the Director of the Agency for Healthcare 
     Quality Research and the Executive Director of the 
     Foundation.
       ``(d) General Structure of Foundation; Nonprofit Status.--
       ``(1) Board of directors.--The Foundation shall have a 
     Board of Directors (in this section referred to as the 
     Board), which shall be established and conducted in 
     accordance with subsection (e). The Board shall establish the 
     general policies of the Foundation for carrying out 
     subsection (b), including the establishment of the bylaws of 
     the Foundation.
       ``(2) Executive director.--The Foundation shall have an 
     executive director (in this section referred to as the 
     `Director'), who shall be appointed by the Board, who shall 
     serve at the pleasure of the Board, and for whom the Board 
     shall establish the rate of compensation. Subject to 
     compliance with the policies and bylaws established by the 
     Board pursuant to paragraph (1), the Director shall be 
     responsible for the daily operations of the Foundation in 
     carrying out subsection (b).
       ``(3) Nonprofit status.--In carrying out subsection (b), 
     the Board shall establish such

[[Page S8501]]

     policies and bylaws under paragraph (1), and the Director 
     shall carry out such activities under paragraph (2), as may 
     be necessary to ensure that the Foundation maintains status 
     as an organization that--
       ``(A) is described in subsection (c)(3) of section 501 of 
     the Internal Revenue Code of 1986; and
       ``(B) is, under subsection (a) of such section, exempt from 
     taxation.
       ``(e) Board of Directors.--
       ``(1) Certain bylaws.--
       ``(A) In general.--The Board shall ensure that bylaws 
     established under subsection (a)(1) include bylaws for the 
     following:
       ``(i) Policies for the selection of the officers, 
     employees, agents, and contractors of the Foundation.
       ``(ii) Policies, including ethical standards, for the 
     acceptance and disposition of donations to the Foundation and 
     for the disposition of the assets of the Foundation.
       ``(iii) Policies for the conduct of the general operations 
     of the Foundation.
       ``(iv) Policies for writing, editing, printing, and 
     publishing of books and other materials, and the acquisition 
     of patents and licenses for devices and procedures developed 
     by the Foundation.
       ``(B) Requirements.--The Board shall ensure that the bylaws 
     established under subsection (d)(1) (and activities carried 
     out under such bylaws) do not--
       ``(i) reflect unfavorably upon the ability of the 
     Foundation, or the Agency for Healthcare Quality Research, to 
     carry out its responsibilities or official duties in a fair 
     and objective manner; or
       ``(ii) compromise, or appear to compromise, the integrity 
     of any governmental program or any officer or employee 
     involved in such program.
       ``(2) Composition.--
       ``(A) In general.--Subject to subparagraph (B), the Board 
     shall be composed of 7 individuals, appointed in accordance 
     with paragraph (4), who collectively possess education or 
     experience appropriate for representing the constituencies 
     described in subsection (b). Each such individual shall be a 
     voting member of the Board.
       ``(B) Additional members.--The Board may, through 
     amendments to the bylaws of the Foundation, provide that the 
     number of members of the Board shall be a greater number than 
     the number specified in subparagraph (A).
       ``(3) Chair.--The Board shall, from among the members of 
     the Board, designate an individual to serve as the chair of 
     the Board (in this subsection referred to as the `Chair').
       ``(4) Appointments, vacancies, and terms.--The following 
     shall apply to the Board:
       ``(A) Any vacancy in the membership of the Board shall be 
     filled by appointment by the Board, after consideration of 
     suggestions made by the Chair and the Director regarding the 
     appointments. Any such vacancy shall be filled not later than 
     the expiration of the 180-day period beginning on the date on 
     which the vacancy occurs.
       ``(B) The term of office of each member of the Board 
     appointed under subparagraph (A) shall be 5 years. A member 
     of the Board may continue to serve after the expiration of 
     the term of the member until the expiration of the 180-day 
     period beginning on the date on which the term of the member 
     expires.
       ``(C) A vacancy in the membership of the Board shall not 
     affect the power of the Board to carry out the duties of the 
     Board. If a member of the Board does not serve the full term 
     applicable under subparagraph (B), the individual appointed 
     to fill the resulting vacancy shall be appointed for the 
     remainder of the term of the predecessor of the individual.
       ``(5) Compensation.--Members of the Board may not receive 
     compensation for service on the Board. The members may be 
     reimbursed for travel, subsistence, and other necessary 
     expenses incurred in carrying out the duties of the Board.
       ``(f) Certain Responsibilities of Executive Director.--In 
     carrying out subsection (d)(2), the Director shall carry out 
     the following functions:
       ``(1) Hire, promote, compensate, and discharge officers and 
     employees of the Foundation, and define the duties of the 
     officers and employees.
       ``(2) Accept and administer donations to the Foundation, 
     and administer the assets of the Foundation.
       ``(3) Establish a process for the selection of candidates 
     for holding endowed positions under subsection (c).
       ``(4) Enter into such financial agreements as are 
     appropriate in carrying out the activities of the Foundation.
       ``(5) Take such action as may be necessary to acquire 
     patents and licenses for devices and procedures developed by 
     the Foundation and the employees of the Foundation.
       ``(6) Adopt, alter, and use a corporate seal, which shall 
     be judicially noticed.
       ``(7) Commence and respond to judicial proceedings in the 
     name of the Foundation.
       ``(8) Other functions that are appropriate in the 
     determination of the Director.
       ``(g) General Provisions.--
       ``(1) Authority for accepting funds.--The Director of the 
     Agency for Healthcare Quality Research may accept and 
     utilize, on behalf of the Federal Government, any gift, 
     donation, bequest, or devise of real or personal property 
     from the Foundation for the purpose of aiding or facilitating 
     the work of such Agency. Funds may be accepted and utilized 
     by such Director under the preceding sentence without regard 
     to whether the funds are designated as general-purpose funds 
     or special-purpose funds. Any funds transferred under this 
     paragraph shall be subject to all Federal limitations 
     relating to federally funded research.
       ``(2) Authority for acceptance of voluntary services.--
       ``(A) In general.--The Director of the Agency for 
     Healthcare Quality Research may accept, on behalf of the 
     Federal Government, any voluntary services provided to such 
     Agency by the Foundation for the purpose of aiding or 
     facilitating the work of such Agency. In the case of an 
     individual, such Director may accept the services provided 
     under the preceding sentence by the individual for not more 
     than 2 years.
       ``(B) Limitation.--The limitation established in 
     subparagraph (A) regarding the period of time in which 
     services may be accepted applies to each individual who is 
     not an employee of the Federal Government and who serves in 
     association with the Agency for Healthcare Quality Research 
     pursuant to financial support from the Foundation.
       ``(3) Administrative control.--No officer, employee, or 
     member of the Board of the Foundation may exercise any 
     administrative or managerial control over any Federal 
     employee.
       ``(4) Applicability of certain standards to non-federal 
     employees.--In the case of any individual who is not an 
     employee of the Federal Government and who serves in 
     association with the Agency for Healthcare Quality Research 
     pursuant to financial support from the Foundation, the 
     Foundation shall negotiate a memorandum of understanding with 
     the individual and the Director of the Agency for Healthcare 
     Quality Research specifying that the individual--
       ``(A) shall be subject to the ethical and procedural 
     standards regulating Federal employment, scientific 
     investigation, and research findings (including publications 
     and patents) that are required of individuals employed by the 
     Agency for Healthcare Quality Research, including standards 
     under this Act, the Ethics in Government Act, and the 
     Technology Transfer Act; and
       ``(B) shall be subject to such ethical and procedural 
     standards under chapter 11 of title 18, United States Code 
     (relating to conflicts of interest), as the Director of such 
     Agency determines is appropriate, except such memorandum may 
     not provide that the individual shall be subject to the 
     standards of section 209 of such chapter.
       ``(5) Financial conflicts of interest.--Any individual who 
     is an officer, employee, or member of the Board of the 
     Foundation may not directly or indirectly participate in the 
     consideration or determination by the Foundation of any 
     question affecting--
       ``(A) any direct or indirect financial interest of the 
     individual; or
       ``(B) any direct or indirect financial interest of any 
     business organization or other entity of which the individual 
     is an officer or employee or in which the individual has a 
     direct or indirect financial interest.
       ``(6) Audits; availability of records.--The Foundation 
     shall--
       ``(A) provide for biennial audits of the financial 
     condition of the Foundation; and
       ``(B) make such audits, and all other records, documents, 
     and other papers of the Foundation, available to the 
     Secretary and the Comptroller General of the United States 
     for examination or audit.
       ``(7) Reports.--
       ``(A) In general.--Not later than February 1 of each fiscal 
     year, the Foundation shall publish a report describing the 
     activities of the Foundation during the preceding fiscal 
     year. Each such report shall include for the fiscal year 
     involved a comprehensive statement of the operations, 
     activities, financial condition, and accomplishments of the 
     Foundation.
       ``(B) Financial requirement.--With respect to the financial 
     condition of the Foundation, each report under subparagraph 
     (A) shall include the source, and a description of, all gifts 
     to the Foundation each report under subparagraph (A) shall 
     include the source, and a description of, all gifts to the 
     Foundation of real or personal property, and the source 
     and amount of all gifts to the Foundation of money. Each 
     such report shall include a specification of any 
     restrictions on the purposes for which gifts to the 
     Foundation may be used.
       ``(C) Public inspection.--The Foundation shall make copies 
     of each report submitted under subparagraph (A) available for 
     public inspection, and shall upon request provide a copy of 
     the report to any individual for a charge not exceeding the 
     cost of providing the copy.
       ``(8) Liaison from the agency for healthcare quality 
     research.--The Director of the Agency for Healthcare Quality 
     Research shall serve as the liaison representative of such 
     Agency and the Foundation.
       ``(h) Federal Funding.--
       ``(1) Authority for financial support.--
       ``(A) In general.--The Secretary, acting through the 
     Director of the Agency for Healthcare Quality Research, 
     shall--
       ``(i) for fiscal year 1999, support the work of the 
     Committee, established pursuant to subsection (i); and
       ``(ii) for fiscal year 2000 and each subsequent fiscal 
     year, make a grant to the Foundation.
       ``(B) Limitations.--Financial support under subparagraph 
     (A) may be expended--
       ``(i) in the case of the Committee, only for the purpose of 
     carrying out the duties established in subsection (i); and

[[Page S8502]]

       ``(ii) in the case of the Foundation, only for the purpose 
     of the administrative expenses of the Foundation.
       ``(C) Remaining funds.--For the purposes described in 
     subparagraph (B), any portion of the financial support 
     provided to the Committee under subparagraph (A)(i) for 
     fiscal year 1999 that remains unobligated after the Committee 
     completes the duties established in subsection (i) shall be 
     available to the Foundation.
       ``(2) Funds.--
       ``(A) Authorization of appropriations.--For the purpose of 
     providing financial support under paragraph (1), there is 
     authorized to be appropriated for the Foundation $500,000 for 
     each fiscal year.
       ``(B) Grants.--For the purpose of grants under paragraph 
     (1), the Secretary may for each fiscal year make available 
     not more than $500,000 from the amounts appropriated for the 
     fiscal year for the programs of the Department of Health and 
     Human Services. Such amounts may be made available without 
     regard to whether amounts have been appropriated under 
     subparagraph (A).
       ``(3) Certain restriction.--If the Foundation receives 
     Federal funds for the purpose of serving as a fiscal 
     intermediary between Federal agencies, the Foundation may not 
     receive such funds for the indirect costs of carrying out 
     such purpose in an amount exceeding 10 percent of the direct 
     costs of carrying out such purpose. The preceding sentence 
     may not be construed as authorizing the expenditure of any 
     grant under paragraph (1) for such purpose.
       ``(i) Establishment of Committee.--
       ``(1) In general.--The Secretary shall establish in 
     accordance with this subsection a committee (referred to in 
     this subsection as the `Committee') to carry out the 
     functions described in paragraph (2).
       ``(2) Functions.--The functions referred to in paragraph 
     (1) for the Committee are as follows:
       ``(A) To carry out such activities as may be necessary to 
     incorporate the Foundation under the laws of the State 
     involved, including serving as incorporators for the 
     Foundation. Such activities shall include ensuring that the 
     articles of incorporation for the Foundation require that the 
     Foundation be established and operated in accordance with the 
     applicable provisions of this part (or any successor to this 
     part), including such provisions as may be in effect pursuant 
     to amendments enacted after the date of the enactment of the 
     Healthcare Quality Research Act of 1998.
       ``(B) To ensure that the Foundation qualifies for and 
     maintains the status described in subsection (d)(3) 
     (regarding taxation).
       ``(C) To establish the general policies and initial bylaws 
     of the Foundation, which bylaws shall include the bylaws 
     described in subsections (d)(3) and (e)(1).
       ``(D) To provide for the initial operation of the 
     Foundation, including providing for quarters, equipment, and 
     staff.
       ``(E) To appoint the initial members of the Board in 
     accordance with the requirements established in subsection 
     (e)(2)(A) for the composition of the Board and establish 
     their respective terms, and other such qualifications as the 
     Committee may determine to be appropriate.
       ``(3) Completion of functions of committee; initial meeting 
     of board.--
       ``(A) In general.--The Committee shall complete the 
     functions required in paragraph (1) not later than 1 year 
     following the appointment of the last member of the 
     Committee. The Committee shall terminate upon the expiration 
     of the 30-day period beginning on the date on which the 
     Secretary determines that the functions have been completed.
       ``(B) Initial meeting.--The initial meeting of the Board 
     shall be held not later than 90 days after the Committee has 
     completed its functions.
       ``(4) Composition.--The Committee shall be composed of 7 
     members, each of whom shall be a voting member. Of the 
     members of the Committee--
       ``(A) not fewer than 2 members shall have broad, general 
     experience in healthcare; and
       ``(B) not fewer than 2 members shall have broad, general 
     experience in the creation of a nonprofit private 
     organization, one of whom shall have expertise in the legal 
     structuring of nonprofit organizations (without regard to 
     whether the individuals have experience in healthcare).
       ``(5) Chair.--The Committee shall, from among the members 
     of the Committee, designate an individual to serve as the 
     chair of the Committee.
       ``(6) Terms; vacancies.--The term of members of the 
     Committee shall be for the duration of the Committee. A 
     vacancy in the membership of the Committee shall not affect 
     the power of the Committee to carry out the duties of the 
     Committee. If a member of the Committee does not serve the 
     full term, the individual appointed to fill the resulting 
     vacancy shall be appointed for the remainder of the term of 
     the predecessor of the individual.
       ``(7) Compensation.--Members of the Committee may not 
     receive compensation for service on the Committee. Members of 
     the Committee may be reimbursed for travel, subsistence, and 
     other necessary expenses incurred in carrying out the duties 
     of the Committee.
       ``(8) Committee support.--The Director of the Agency for 
     Healthcare Quality Research may, from amounts available to 
     the Director for the general administration of such Agency, 
     provide staff and financial support to assist the Committee 
     with carrying out the functions described in paragraph (2). 
     In providing such staff and support, the Director may both 
     detail employees and contract for assistance.

                      ``PART D--GENERAL PROVISIONS

     ``SEC. 931. ADVISORY COUNCIL FOR HEALTHCARE QUALITY RESEARCH.

       ``(a) Establishment.--There is established an advisory 
     council to be known as the Advisory Council for Healthcare 
     Quality Research.
       ``(b) Duties.--
       ``(1) In general.--The Advisory Council shall advise the 
     Secretary and the Director with respect to activities to 
     carry out the purpose of the Agency under section 901(b).
       ``(2) Certain recommendations.--Activities of the Advisory 
     Council under paragraph (1) shall include making 
     recommendations to the Director regarding--
       ``(A) priorities regarding healthcare research, especially 
     studies related to quality, outcomes, cost and the 
     utilization of, and access to, healthcare services;
       ``(B) the field of healthcare research and related 
     disciplines, especially issues related to training needs, and 
     dissemination of information on quality; and
       ``(C) the appropriate role of the Agency in each of these 
     areas in light of private sector activity and identification 
     of opportunities for public-private sector partnerships.
       ``(c) Membership.--
       ``(1) In general.--The Advisory Council shall, in 
     accordance with this subsection, be composed of appointed 
     members and ex officio members. All members of the Advisory 
     Council shall be voting members other than the individuals 
     designated under paragraph (3)(B) who shall be ex officio 
     members of the Advisory Council.
       ``(2) Appointed members.--The Secretary shall appoint to 
     the Advisory Council 21 appropriately qualified individuals. 
     At least 17 members of the Advisory Council shall be 
     representatives of the public who are not officers or 
     employees of the United States. The Secretary shall ensure 
     that the appointed members of the Council, as a group, are 
     representative of professions and entities concerned with, or 
     affected by, activities under this title and under section 
     1142 of the Social Security Act. Of such members--
       ``(A) 4 shall be individuals distinguished in the conduct 
     of research, demonstration projects, and evaluations with 
     respect to healthcare;
       ``(B) 4 shall be individuals distinguished in the practice 
     of medicine of which at least 1 shall be a primary care 
     practitioner;
       ``(C) 3 shall be individuals distinguished in the health 
     professions;
       ``(D) 4 shall be individuals either representing the 
     private healthcare sector, including health plans, providers, 
     and purchasers or individuals distinguished as administrators 
     of healthcare delivery systems;
       ``(E) 4 shall be individuals distinguished in the fields of 
     healthcare quality improvement, economics, information 
     systems, law, ethics, business, or public policy; and
       ``(F) 2 shall be individuals representing the interests of 
     patients and consumers of healthcare.
       ``(3) Ex officio members.--The Secretary shall designate as 
     ex officio members of the Advisory Council--
       ``(A) the Director of the National Institutes of Health, 
     the Director of the Centers for Disease Control and 
     Prevention, the Administrator of the Health Care Financing 
     Administration, the Assistant Secretary of Defense (Health 
     Affairs), and the Chief Medical Officer of the Department of 
     Veterans Affairs; and
       ``(B) such other Federal officials as the Secretary may 
     consider appropriate.
       ``(d) Terms.--Members of the Advisory Council appointed 
     under subsection (c)(2) shall serve for a term of 3 years. A 
     member of the Council appointed under such subsection may 
     continue to serve after the expiration of the term of the 
     members until a successor is appointed.
       ``(e) Vacancies.--If a member of the Advisory Council 
     appointed under subsection (c)(2) does not serve the full 
     term applicable under subsection (d), the individual 
     appointed to fill the resulting vacancy shall be appointed 
     for the remainder of the term of the predecessor of the 
     individual.
       ``(f) Chair.--The Director shall, from among the members of 
     the Advisory Council appointed under subsection (c)(2), 
     designate an individual to serve as the chair of the Advisory 
     Council.
       ``(g) Meetings.--The Advisory Council shall meet not less 
     than once during each discrete 4-month period and shall 
     otherwise meet at the call of the Director or the chair.
       ``(h) Compensation and Reimbursement of Expenses.--
       ``(1) Appointed members.--Members of the Advisory Council 
     appointed under subsection (c)(2) shall receive compensation 
     for each day (including travel time) engaged in carrying out 
     the duties of the Advisory Council unless declined by the 
     member. Such compensation may not be in an amount in excess 
     of the maximum rate of basic pay payable for GS-18 of the 
     General Schedule.
       ``(2) Ex officio members.--Officials designated under 
     subsection (c)(3) as ex officio members of the Advisory 
     Council may not receive compensation for service on the 
     Advisory Council in addition to the compensation otherwise 
     received for duties carried out as officers of the United 
     States.
       ``(i) Staff.--The Director shall provide to the Advisory 
     Council such staff, information, and other assistance as may 
     be necessary to carry out the duties of the Council.

[[Page S8503]]

     ``SEC. 932. PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS.

       ``(a) Requirement of Review.--
       ``(1) In general.--Appropriate technical and scientific 
     peer review shall be conducted with respect to each 
     application for a grant, cooperative agreement, or contract 
     under this title.
       ``(2) Reports to director.--Each peer review group to which 
     an application is submitted pursuant to paragraph (1) shall 
     report its finding and recommendations respecting the 
     application to the Director in such form and in such manner 
     as the Director shall require.
       ``(b) Approval as Precondition of Awards.--The Director may 
     not approve an application described in subsection (a)(1) 
     unless the application is recommended for approval by a peer 
     review group established under subsection (c).
       ``(c) Establishment of Peer Review Groups.--
       ``(1) In general.--The Director shall establish such 
     technical and scientific peer review groups as may be 
     necessary to carry out this section. Such groups shall be 
     established without regard to the provisions of title 5, 
     United States Code, that govern appointments in the 
     competitive service, and without regard to the provisions of 
     chapter 51, and subchapter III of chapter 53, of such title 
     that relate to classification and pay rates under the General 
     Schedule.
       ``(2) Membership.--The members of any peer review group 
     established under this section shall be appointed from among 
     individuals who by virtue of their training or experience are 
     eminently qualified to carry out the duties of such peer 
     review group. Officers and employees of the United States may 
     not constitute more than 25 percent of the membership of any 
     such group. Such officers and employees may not receive 
     compensation for service on such groups in addition to the 
     compensation otherwise received for duties carried out as 
     such officers and employees.
       ``(3) Duration.--Notwithstanding section 14(a) of the 
     Federal Advisory Committee Act, peer review groups 
     established under this section shall continue in existence 
     until otherwise provided by law.
       ``(4) Qualifications.--Members of any peer-review group 
     shall, at a minimum, meet the following requirements:
       ``(A) Such members shall agree in writing to treat 
     information received, records, reports, and recommendations 
     as confidential information.
       ``(B) Such members shall agree in writing to recuse 
     themselves from participation in the peer-review of specific 
     applications which present a potential personal conflict of 
     interest or appearance of such conflict, including employment 
     in the applicant organization, stock ownership, or any 
     financial or other arrangement that might introduce bias in 
     the process of peer-review.
       ``(d) Authority for Procedural Adjustments in Certain 
     Cases.--In the case of applications described in subsection 
     (a)(1) for financial assistance whose direct costs will not 
     exceed $100,000, the Director may make appropriate 
     adjustments in the procedures otherwise established by the 
     Director for the conduct of peer review under this section. 
     Such adjustments may be made for the purpose of encouraging 
     the entry of individuals into the field of research, for the 
     purpose of encouraging clinical practice-oriented research, 
     and for such other purposes as the Director may determine to 
     be appropriate.
       ``(e) Regulations.--The Secretary shall issue regulations 
     for the conduct of peer review under this section.

     ``SEC. 933. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, 
                   COLLECTION, AND DISSEMINATION OF DATA.

       ``(a) Standards With Respect to Utility of Data.--
       ``(1) In general.--With respect to data developed or 
     collected by any entity for the purpose described in section 
     901(b), the Director shall, in order to assure that utility, 
     accuracy, and sufficiency of such data for all interested 
     entities, establish recommendations for methods of developing 
     and collecting such data. Such recommendations shall include 
     recommendations for the development and collection of data on 
     the outcomes of healthcare services and procedures. Such 
     recommendations shall recognize the differences between types 
     of healthcare plans, delivery systems, healthcare providers, 
     and provider arrangements.
       ``(2) Relationship with medicare program.--In any case 
     where recommendations under paragraph (1) may affect the 
     administration of the program under title XVIII of the Social 
     Security Act, they shall be in the form of recommendations to 
     the Secretary for such program.
       ``(b) Statistics.--The Director shall--
       ``(1) take such action as may be necessary to assure that 
     statistics developed under this title are of high quality, 
     timely, and comprehensive, as well as specific, standardized, 
     and adequately analyzed and indexed; and
       ``(2) publish, make available, and disseminate such 
     statistics on as wide a basis as is practicable.
       ``(c) Authority Regarding Certain Requests.--Upon request 
     of a public or private entity, the Director may undertake 
     research or analyses otherwise authorized by this title 
     pursuant to arrangements under which such entity will pay the 
     cost of the services provided. Amounts received by the 
     Director under such arrangements shall be available to the 
     Director for obligation until expended.

     ``SEC. 934. DISSEMINATION OF INFORMATION.

       ``(a) In General.--The Administrator shall--
       ``(1) without regard to section 501 of title 44, United 
     States Code, promptly publish, make available, and otherwise 
     disseminate, in a form understandable and on as broad a basis 
     as practicable so as to maximize its use, the results of 
     research, demonstration projects, and evaluations conducted 
     or supported under this title;
       ``(2) promptly make available to the public data developed 
     in such research, demonstration projects, and evaluations;
       ``(3) building upon, but without duplicating, information 
     services provided by the National Library of Medicine and 
     considering applicable interagency agreements, provide 
     indexing, abstracting, translating, publishing, and other 
     services leading to a more effective and timely dissemination 
     of information on research, demonstration projects, and 
     evaluations with respect to healthcare to public and private 
     entities and individuals engaged in the improvement of 
     healthcare delivery and the general public, and undertake 
     programs to develop new or improved methods for making such 
     information available; and
       ``(4) as appropriate, provide technical assistance to State 
     and local government and health agencies and conduct liaison 
     activities to such agencies to foster dissemination.
       ``(b) Prohibition Against Restrictions.--Except as provided 
     in subsection (c), the Director may not restrict the 
     publication or dissemination of data from, or the results of, 
     projects conducted or supported under this title.
       ``(c) Limitation on Use of Certain Information.--No 
     information, if an establishment or person supplying the 
     information or described in it is identifiable, obtained in 
     the course of activities undertaken or supported under this 
     title may be used for any purpose other than the purpose for 
     which it was supplied unless such establishment or person has 
     consented (as determined under regulations of the Director) 
     to its use for such other purpose. Such information may not 
     be published or released in other form if the person who 
     supplied the information or who is described in it is 
     identifiable unless such person has consented (as determined 
     regulations of the Director) to its publication or release in 
     other form.
       ``(d) Penalty.--Any person who violates subsection (c) 
     shall be subject to a civil monetary penalty of not more than 
     $10,000 for each such violation involved. Such penalty shall 
     be imposed and collected in the same manner as civil money 
     penalties under subsection (a) of section 1128A of the Social 
     Security Act are imposed and collected under that section.

     ``SEC. 935. ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND 
                   CONTRACTS.

       ``(a) Priorities.--In establishing priorities to carry out 
     this title, subject to the availability of funds, the 
     Director shall consider--
       ``(1) the needs and priorities of healthcare programs that 
     are operated by or supported, in whole or in part, by Federal 
     agencies;
       ``(2) the healthcare needs of low-income groups, minority 
     groups, children, the elderly, and persons with special 
     healthcare needs and issues related to the delivery of 
     healthcare services in rural areas (including frontier 
     areas).
       ``(b) Financial Conflicts of Interest.--With respect to 
     projects for which awards of grants, cooperative agreements, 
     or contracts are authorized to be made under this title, the 
     Director shall by regulation define--
       ``(1) the specific circumstances that constitute financial 
     interests in such projects that will, or may be reasonably 
     expected to, create a bias in favor of obtaining results in 
     the projects that are consistent with such interests; and
       ``(2) the actions that will be taken by the Director in 
     response to any such interests identified by the Director.
       ``(c) Requirement of Application.--The Director may not, 
     with respect to any program under this title authorizing the 
     provision of grants, cooperative agreements, or contracts, 
     provide any such financial assistance unless an application 
     for the assistance is submitted to the Secretary and the 
     application is in such form, is made in such manner, and 
     contains such agreements, assurances, and information as the 
     Director determines to be necessary to carry out the program 
     in involved.
       ``(d) Provision of Supplies and Services in Lieu of 
     Funds.--
       ``(1) In general.--Upon the request of an entity receiving 
     a grant, cooperative agreement, or contract under this title, 
     the Secretary may, subject to paragraph (2), provide 
     supplies, equipment, and services for the purpose of aiding 
     the entity in carrying out the project involved and, for such 
     purpose, may detail to the entity any officer or employee of 
     the Department of Health and Human Services.
       ``(2) Corresponding reduction in funds.--With respect to a 
     request described in paragraph (1), the Secretary shall 
     reduce the amount of the financial assistance involved by an 
     amount equal to the costs of detailing personnel and the fair 
     market value of any supplies, equipment, or services provided 
     by the Director. The Secretary shall, for the payment of 
     expenses incurred in complying with such request, expend the 
     amounts withheld.
       ``(e) Applicability of Certain Provisions With Respect to 
     Contracts.--Contracts may be entered into under this part 
     without

[[Page S8504]]

     regard to sections 3648 and 3709 of the Revised Statutes (31 
     U.S.C. 529; 41 U.S.C. 5).

     ``SEC. 936. CERTAIN ADMINISTRATIVE AUTHORITIES.

       ``(a) Deputy Director and Other Officers and Employees.--
       ``(1) Deputy director.--The Director may appoint a deputy 
     director for the Agency.
       ``(2) Other officers and employees.--The Director may 
     appoint and fix the compensation of such officers and 
     employees as may be necessary to carry out this title. Except 
     as otherwise provided by law, such officers and employees 
     shall be appointed in accordance with the civil service laws 
     and their compensation fixed in accordance with title 5, 
     United States Code.
       ``(b) Facilities.--The Secretary, in carrying out this 
     title--
       ``(1) may acquire, without regard to the Act of March 3, 
     1877 (40 U.S.C. 34), by lease or otherwise through the 
     Director of General Services, buildings or portions of 
     buildings in the District of Columbia or communities located 
     adjacent to the District of Columbia for use for a period not 
     to exceed 10 years; and
       ``(2) may acquire, construct, improve, repair, operate, and 
     maintain laboratory, research, and other necessary facilities 
     and equipment, and such other real or personal property 
     (including patents) as the Secretary deems necessary.
       ``(c) Provision of Financial Assistance.--The Director, in 
     carrying out this title, may make grants to public and 
     nonprofit entities and individuals, and may enter into 
     cooperative agreements or contracts with public and private 
     entities and individuals.
       ``(d) Utilization of Certain Personnel and Resources.--
       ``(1) Department of health and human services.--The 
     Director, in carrying out this title, may utilize personnel 
     and equipment, facilities, and other physical resources of 
     the Department of Health and Human Services, permit 
     appropriate (as determined by the Secretary) entities and 
     individuals to utilize the physical resources of such 
     Department, and provide technical assistance and advice.
       ``(2) Other agencies.--The Director, in carrying out this 
     title, may use, with their consent, the services, equipment, 
     personnel, information, and facilities of other Federal, 
     State, or local public agencies, or of any foreign 
     government, with or without reimbursement of such agencies.
       ``(e) Consultants.--The Secretary, in carrying out this 
     title, may secure, from time to time and for such periods as 
     the Director deems advisable but in accordance with section 
     3109 of title 5, United States Code, the assistance and 
     advice of consultants from the United States or abroad.
       ``(f) Experts.--
       ``(1) In general.--The Secretary may, in carrying out this 
     title, obtain the services of not more than 50 experts or 
     consultants who have appropriate scientific or professional 
     qualifications. Such experts or consultants shall be obtained 
     in accordance with section 3109 of title 5, United States 
     Code, except that the limitation in such section on the 
     duration of service shall not apply.
       ``(2) Travel expenses.--
       ``(A) In general.--Experts and consultants whose services 
     are obtained under paragraph (1) shall be paid or reimbursed 
     for their expenses associated with traveling to and from 
     their assignment location in accordance with sections 5724, 
     5724a(a), 5724a(c), and 5726(C) of title 5, United States 
     Code.
       ``(B) Limitation.--Expenses specified in subparagraph (A) 
     may not be allowed in connection with the assignment of an 
     expert or consultant whose services are obtained under 
     paragraph (1) unless and until the expert agrees in writing 
     to complete the entire period of assignment, or 1 year, 
     whichever is shorter, unless separated or reassigned for 
     reasons that are beyond the control of the expert or 
     consultant and that are acceptable to the Secretary. If the 
     expert or consultant violates the agreement, the money spent 
     by the United States for the expenses specified in 
     subparagraph (A) is recoverable from the expert or consultant 
     as a debt of the United States. The Secretary may waive in 
     whole or in part a right of recovery under this subparagraph.
       ``(g) Voluntary and Uncompensated Services.--The Director, 
     in carrying out this title, may accept voluntary and 
     uncompensated services.

     ``SEC. 937. FUNDING.

       ``(a) Intent.--To ensure that the United States's 
     investment in biomedical research is rapidly translated into 
     improvements in the quality of patient care, there must be a 
     corresponding investment in research on the most effective 
     clinical and organizational strategies for use of these 
     findings in daily practice. The authorization levels in 
     subsections (b) and (c) provide for a proportionate increase 
     in healthcare research as the United State's investment in 
     biomedical research increases.
       ``(b) Authorization of Appropriations.--For the purpose of 
     carrying out this title, there are authorized to be 
     appropriated $180,000,000 for fiscal year 1999, and such sums 
     as may be necessary for each of the fiscal years 2000 through 
     2003.
       ``(c) Evaluations.--In addition to amounts available 
     pursuant to subsection (b) for carrying out this title, there 
     shall be made available for such purpose, from the amounts 
     made available pursuant to section 241 (relating to 
     evaluations), an amount equal to 40 percent of the maximum 
     amount authorized in such section 241 to be made available 
     for a fiscal year.
       ``(d) Centers for Education and Research on Therapeutics.--
     For the purpose of carrying out the demonstration program 
     regarding centers for education and research on therapeutics 
     under section 912(b), there are authorized to be appropriated 
     $2,000,000 for fiscal year 1998, and $3,000,000 for fiscal 
     year 1999, and such sums as may be necessary for each of the 
     fiscal years 2000 through 2003.

     ``SEC. 938. DEFINITIONS.

       ``In this title:
       ``(1) Advisory council.--The term `Advisory Council' means 
     the Advisory Council on Healthcare Quality Research 
     established under section 931.
       ``(2) Agency.--The term `Agency' means the Agency for 
     Healthcare Quality.
       ``(3) Director.--The term `Director' means the Director for 
     the Agency for Healthcare Quality Research.''.

     SEC. 403. REFERENCES.

       Effective upon the date of enactment of this Act, any 
     reference in law to the ``Agency for Health Care Policy and 
     Research'' shall be deemed to be a reference to the ``Agency 
     for Healthcare Quality Research''.

     SEC. 404. STUDY.

       (a) Study.--Not later than 30 days after the date of 
     enactment of any Act providing for a qualifying health care 
     benefit (as defined in subsection (b), the Secretary of 
     Health and Human Services, in consultation with the Agency 
     for Healthcare Quality Research, the National Institutes of 
     Health, and the Institute of Medicine, shall conduct a study 
     concerning such benefit that scientifically evaluates--
       (1) the safety and efficacy of the benefit, particularly 
     the effect of the benefit on outcomes of care;
       (2) the cost, benefits and value of such benefit;
       (3) the benefit in comparison to alternative approaches in 
     improving care; and
       (4) the overall impact that such benefit will have on 
     health care as measured through research.
       (b) Qualifying Health Care Benefit.--In this section, the 
     term ``qualifying health care benefit'' means a health care 
     benefit that--
       (1) is disease- or health condition-specific;
       (2) requires the provision of or coverage for health care 
     items or services;
       (3) applies to group health plan, individual health plans, 
     or health insurance issuers under part 7 of subtitle B of 
     title I of the Employee Retirement Income Security Act of 
     1974 (29 U.S.C. 1181 et seq.) or under title XXVII of the 
     Public Health Service Act (42 U.S.C. 300gg et seq.); and
       (4) was provided under an Act (or amendment) enacted on or 
     after January 1, 1998.
       (c) Reports.--Not later than 3 years after the date of 
     enactment of any Act described in subsection (a), the 
     Secretary of Health and Human Services shall prepare and 
     submit to the appropriate committees of Congress a report 
     based on the study conducted under such subsection with 
     respect to the qualifying health care benefit involved.

            TITLE V--WOMEN'S HEALTH RESEARCH AND PREVENTION

     SEC. 501. SHORT TITLE.

       This title may be cited as the ``Women's Health Research 
     and Prevention Amendments of 1998''.

   Subtitle A--Provisions Relating to Women's Health Research at the 
                     National Institutes of Health

     SEC. 511. EXTENSION OF PROGRAM FOR RESEARCH AND AUTHORIZATION 
                   OF NATIONAL PROGRAM OF EDUCATION REGARDING THE 
                   DRUG DES.

       (a) In General.--Section 403A(e) of the Public Health 
     Service Act (42 U.S.C. 283a(e)) is amended by striking 
     ``1996'' and inserting ``2001''.
       (b) National Program for Education of Health Professionals 
     and Public.--From amounts appropriated for carrying out 
     section 403A of the Public Health Service Act (42 U.S.C. 
     283a), the Secretary of Health and Human Services, acting 
     through the heads of the appropriate agencies of the Public 
     Health Service, shall carry out a national program for the 
     education of health professionals and the public with respect 
     to the drug diethylstilbestrol (commonly known as DES). To 
     the extent appropriate, such national program shall use 
     methodologies developed through the education demonstration 
     program carried out under such section 403A. In developing 
     and carrying out the national program, the Secretary shall 
     consult closely with representatives of nonprofit private 
     entities that represent individuals who have been exposed to 
     DES and that have expertise in community-based information 
     campaigns for the public and for health care providers. The 
     implementation of the national program shall begin during 
     fiscal year 1999.

     SEC. 512. RESEARCH ON OSTEOPOROSIS, PAGET'S DISEASE, AND 
                   RELATED BONE DISORDERS.

       Section 409A(d) of the Public Health Service Act (42 U.S.C. 
     284e(d)) is amended by striking ``and 1996'' and inserting 
     ``through 2001''.

     SEC. 513. RESEARCH ON CANCER.

       (a) In General.--Section 417B(a) of the Public Health 
     Service Act (42 U.S.C. 286a-8(a)) is amended by striking 
     ``and 1996'' and inserting ``through 2001''.
       (b) Research on Breast Cancer.--Section 417B(b)(1) of the 
     Public Health Service Act (42 U.S.C. 286a-8(b)(1)) is 
     amended--
       (1) in subparagraph (A), by striking ``and 1996'' and 
     inserting ``through 2001''; and
       (2) in subparagraph (B), by striking ``and 1996'' and 
     inserting ``through 2001''.

[[Page S8505]]

       (c) Research on Ovarian and Related Cancer Research.--
     Section 417B(b)(2) of the Public Health Service Act (42 
     U.S.C. 286a-8(b)(2)) is amended by striking ``and 1996'' and 
     inserting ``through 2001''.

     SEC. 514. RESEARCH ON HEART ATTACK, STROKE, AND OTHER 
                   CARDIOVASCULAR DISEASES IN WOMEN.

       Subpart 2 of part C of title IV of the Public Health 
     Service Act (42 U.S.C. 285b et seq.) is amended by inserting 
     after section 424 the following:


   ``heart attack, stroke, and other cardiovascular diseases in women

       ``Sec. 424A. (a) In General.--The Director of the Institute 
     shall expand, intensify, and coordinate research and related 
     activities of the Institute with respect to heart attack, 
     stroke, and other cardiovascular diseases in women.
       ``(b) Coordination With Other Institutes.--The Director of 
     the Institute shall coordinate activities under subsection 
     (a) with similar activities conducted by the other national 
     research institutes and agencies of the National Institutes 
     of Health to the extent that such Institutes and agencies 
     have responsibilities that are related to heart attack, 
     stroke, and other cardiovascular diseases in women.
       ``(c) Certain Programs.--In carrying out subsection (a), 
     the Director of the Institute shall conduct or support 
     research to expand the understanding of the causes of, and to 
     develop methods for preventing, cardiovascular diseases in 
     women. Activities under such subsection shall include 
     conducting and supporting the following:
       ``(1) Research to determine the reasons underlying the 
     prevalence of heart attack, stroke, and other cardiovascular 
     diseases in women, including African-American women and other 
     women who are members of racial or ethnic minority groups.
       ``(2) Basic research concerning the etiology and causes of 
     cardiovascular diseases in women.
       ``(3) Epidemiological studies to address the frequency and 
     natural history of such diseases and the differences among 
     men and women, and among racial and ethnic groups, with 
     respect to such diseases.
       ``(4) The development of safe, efficient, and cost-
     effective diagnostic approaches to evaluating women with 
     suspected ischemic heart disease.
       ``(5) Clinical research for the development and evaluation 
     of new treatments for women, including rehabilitation.
       ``(6) Studies to gain a better understanding of methods of 
     preventing cardiovascular diseases in women, including 
     applications of effective methods for the control of blood 
     pressure, lipids, and obesity.
       ``(7) Information and education programs for patients and 
     health care providers on risk factors associated with heart 
     attack, stroke, and other cardiovascular diseases in women, 
     and on the importance of the prevention or control of such 
     risk factors and timely referral with appropriate diagnosis 
     and treatment. Such programs shall include information and 
     education on health-related behaviors that can improve such 
     important risk factors as smoking, obesity, high blood 
     cholesterol, and lack of exercise.
       ``(d) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there is authorized to be 
     appropriated such sums as may be necessary for each of the 
     fiscal years 1999 through 2001. The authorization of 
     appropriations established in the preceding sentence is in 
     addition to any other authorization of appropriation that is 
     available for such purpose.''.

     SEC. 515. AGING PROCESSES REGARDING WOMEN.

       Section 445I of the Public Health Service Act (42 U.S.C. 
     285e-11) is amended by striking ``and 1996'' and inserting 
     ``through 2001''.

     SEC. 516. OFFICE OF RESEARCH ON WOMEN'S HEALTH.

       Section 486(d)(2) of the Public Health Service Act (42 
     U.S.C. 287d(d)(2)) is amended by striking ``Director of the 
     Office'' and inserting ``Director of the National Institutes 
     of Health''.

 Subtitle B--Provisions Relating to Women's Health at the Centers for 
                     Disease Control and Prevention

     SEC. 521. NATIONAL CENTER FOR HEALTH STATISTICS.

       Section 306(n) of the Public Health Service Act (42 U.S.C. 
     242k(n)) is amended--
       (1) in paragraph (1), by striking ``through 1998'' and 
     inserting ``through 2002''; and
       (2) in paragraph (2), by striking ``through 1998'' and 
     inserting ``through 2002''.

     SEC. 522. NATIONAL PROGRAM OF CANCER REGISTRIES.

       Section 399L(a) of the Public Health Service Act (42 U.S.C. 
     280e-4(a)) is amended by striking ``through 1998'' and 
     inserting ``through 2002''.

     SEC. 523. NATIONAL BREAST AND CERVICAL CANCER EARLY DETECTION 
                   PROGRAM.

       (a) Grants.--Section 1501(b) of the Public Health Service 
     Act (42 U.S.C. 300k(b)) is amended--
       (1) in paragraph (1), by striking ``nonprofit''; and
       (2) in paragraph (2), by striking ``that are not nonprofit 
     entities''.
       (b) Preventive Health.--Section 1509(d) of the Public 
     Health Service Act (42 U.S.C. 300n-4a(d)(1)) is amended by 
     striking ``through 1998'' and inserting ``through 2002''.
       (c) General Program.--Section 1510(a) of the Public Health 
     Service Act (42 U.S.C. 300n-5(a)) is amended by striking 
     ``through 1998'' and inserting ``through 2002''.

     SEC. 524. CENTERS FOR RESEARCH AND DEMONSTRATION OF HEALTH 
                   PROMOTION.

       Section 1706(e) of the Public Health Service Act (42 U.S.C. 
     300u-5(e)) is amended by striking ``through 1998'' and 
     inserting ``through 2002''.

     SEC. 525. COMMUNITY PROGRAMS ON DOMESTIC VIOLENCE.

       Section 318(h)(2) of the Family Violence Prevention and 
     Services Act (42 U.S.C. 10418(h)(2)) is amended by striking 
     ``fiscal year 1997'' and inserting ``for each of the fiscal 
     years 1997 through 2002''.

              Subtitle C--Women's Health and Cancer Rights

     SEC. 531. SHORT TITLE.

       This subtitle may be cited as the ``Women's Health and 
     Cancer Rights Act of 1998''.

     SEC. 532. FINDINGS.

       Congress finds that--
       (1) the offering and operation of health plans affect 
     commerce among the States;
       (2) health care providers located in a State serve patients 
     who reside in the State and patients who reside in other 
     States; and
       (3) in order to provide for uniform treatment of health 
     care providers and patients among the States, it is necessary 
     to cover health plans operating in 1 State as well as health 
     plans operating among the several States.

     SEC. 533. AMENDMENTS TO THE EMPLOYEE RETIREMENT INCOME 
                   SECURITY ACT OF 1974.

       (a) In General.--Subpart B of part 7 of subtitle B of title 
     I of the Employee Retirement Income Security Act of 1974 (29 
     U.S.C. 1185 et seq.), as amended by sections 111 and 302, is 
     further amended by adding at the end the following new 
     section:

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

       ``(a) Inpatient Care.--
       ``(1) In general.--A group health plan, and a health 
     insurance issuer providing health insurance coverage in 
     connection with a group health plan, that provides medical 
     and surgical benefits shall ensure that inpatient coverage 
     with respect to the surgical treatment of breast cancer 
     (including a mastectomy, lumpectomy, or lymph node dissection 
     for 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 scientific 
     evidence-based practices or guidelines, in consultation with 
     the patient, to be medically appropriate.
       ``(2) Exception.--Nothing in this section shall be 
     construed as requiring the provision of inpatient coverage if 
     the attending physician in consultation with the patient 
     determine that a shorter period of hospital stay is medically 
     appropriate.
       ``(b) Reconstructive Surgery.--A group health plan, and a 
     health insurance issuer providing health insurance coverage 
     in connection with a group health plan, that provides medical 
     and surgical benefits with respect to a mastectomy shall 
     ensure that, in a case in which a mastectomy patient elects 
     breast reconstruction, coverage is provided for--
       ``(1) all stages of reconstruction of the breast on which 
     the mastectomy has been performed;
       ``(2) surgery and reconstruction of the other breast to 
     produce a symmetrical appearance; and
       ``(3) the costs of prostheses and complications of 
     mastectomy including lymphedemas;

     in the manner determined by the attending physician and the 
     patient to be appropriate. Such coverage may be subject to 
     annual deductibles and coinsurance provisions as may be 
     deemed appropriate and as are consistent with those 
     established for other benefits under the plan or coverage. 
     Written notice of the availability of such coverage shall be 
     delivered to the participant upon enrollment and annually 
     thereafter.
       ``(c) Notice.--A group health plan, and a health insurance 
     issuer providing health insurance coverage in connection with 
     a group health plan shall provide notice to each participant 
     and beneficiary under such plan regarding the coverage 
     required by this section in accordance with regulations 
     promulgated by the Secretary. Such notice shall be in writing 
     and prominently positioned in any literature or 
     correspondence made available or distributed by the plan or 
     issuer and shall be transmitted--
       ``(1) in the next mailing made by the plan or issuer to the 
     participant or beneficiary;
       ``(2) as part of any yearly informational packet sent to 
     the participant or beneficiary; or
       ``(3) not later than January 1, 1999;

     whichever is earlier.
       ``(d) No Authorization Required.--
       ``(1) In general.--An attending physician shall not be 
     required to obtain authorization from the plan or issuer for 
     prescribing any length of stay in connection with a 
     mastectomy, a lumpectomy, or a lymph node dissection for the 
     treatment of breast cancer.
       ``(2) Prenotification.--Nothing in this section shall be 
     construed as preventing a group health plan from requiring 
     prenotification of an inpatient stay referred to in this 
     section if such requirement is consistent with terms

[[Page S8506]]

     and conditions applicable to other inpatient benefits under 
     the plan, except that the provision of such inpatient stay 
     benefits shall not be contingent upon such notification.
       ``(e) Prohibitions.--A group health plan, and a health 
     insurance issuer offering group health insurance coverage in 
     connection with a group health plan, may not--
       ``(1) deny to a patient eligibility, or continued 
     eligibility, to enroll or to renew coverage under the terms 
     of the plan, solely for the purpose of avoiding the 
     requirements of this section;
       ``(2) provide monetary payments or rebates to individuals 
     to encourage such individuals to accept less than the minimum 
     protections available under this section;
       ``(3) penalize or otherwise reduce or limit the 
     reimbursement of an attending provider because such provider 
     provided care to an individual participant or beneficiary in 
     accordance with this section;
       ``(4) provide incentives (monetary or otherwise) to an 
     attending provider to induce such provider to provide care to 
     an individual participant or beneficiary in a manner 
     inconsistent with this section; and
       ``(5) subject to subsection (f)(2), restrict benefits for 
     any portion of a period within a hospital length of stay 
     required under subsection (a) in a manner which is less 
     favorable than the benefits provided for any preceding 
     portion of such stay.
       ``(f) Rules of Construction.--
       ``(1) In general.--Nothing in this section shall be 
     construed to require a patient who is a participant or 
     beneficiary--
       ``(A) to undergo a mastectomy or lymph node dissection in a 
     hospital; or
       ``(B) to stay in the hospital for a fixed period of time 
     following a mastectomy or lymph node dissection.
       ``(2) Cost sharing.--Nothing in this section shall be 
     construed as preventing a group health plan or issuer from 
     imposing deductibles, coinsurance, or other cost-sharing in 
     relation to benefits for hospital lengths of stay in 
     connection with a mastectomy or lymph node dissection for the 
     treatment of breast cancer under the plan (or under health 
     insurance coverage offered in connection with a group health 
     plan), except that such coinsurance or other cost-sharing for 
     any portion of a period within a hospital length of stay 
     required under subsection (a) may not be greater than such 
     coinsurance or cost-sharing for any preceding portion of such 
     stay.
       ``(3) Level and type of reimbursements.--Nothing in this 
     section shall be construed to prevent a group health plan or 
     a health insurance issuer offering group health insurance 
     coverage from negotiating the level and type of reimbursement 
     with a provider for care provided in accordance with this 
     section.
       ``(g) Preemption, Relation to State Laws.--
       ``(1) In general.--Nothing in this section shall be 
     construed to preempt any State law with respect to health 
     insurance coverage that--
       ``(A) relates to hospital length of stays after a 
     mastectomy, lumpectomy, or lymph node dissection;
       ``(B) relates to coverage of reconstructive breast surgery 
     after a mastectomy, lumpectomy, of lymph node dissection; or
       ``(C) requires coverage for breast cancer treatments 
     (including breast reconstruction) in accordance with 
     scientific evidence-based practices or guidelines recommended 
     by established medical associations.
       ``(2) Application of section.--With respect to a State 
     law--
       ``(A) described in paragraph (1)(A), the provisions of this 
     section relating to breast reconstruction shall apply in such 
     State; and
       ``(B) described in paragraph (1)(B), the provisions of this 
     section relating to length of stays for surgical breast 
     treatment shall apply in such State.
       ``(3) Erisa.--Nothing in this section shall be construed to 
     affect or modify the provisions of section 514 with respect 
     to group health plans.''.
       (b) Clerical Amendment.--The table of contents in section 1 
     of the Employee Retirement Income Security Act of 1974 (29 
     U.S.C. 1001 note) is amended by inserting after the item 
     relating to section 714 the following new item:

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

       (c) Effective Dates.--The amendments made by this section 
     shall apply with respect to plan years beginning on or after 
     the date of enactment of this Act.

     SEC. 534. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT 
                   RELATING TO THE GROUP MARKET.

       (a) In General.--Subpart 2 of part A of title XXVII of the 
     Public Health Service Act (42 U.S.C. 300gg-4 et seq.), as 
     amended by section 303(a), is further amended by adding at 
     the end the following new section:

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

       ``(a) Inpatient Care.--
       ``(1) In general.--A group health plan, and a health 
     insurance issuer providing health insurance coverage in 
     connection with a group health plan, that provides medical 
     and surgical benefits shall ensure that inpatient coverage 
     with respect to the surgical treatment of breast cancer 
     (including a mastectomy, lumpectomy, or lymph node dissection 
     for 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 scientific 
     evidence-based practices or guidelines, in consultation with 
     the patient, to be medically appropriate.
       ``(2) Exception.--Nothing in this section shall be 
     construed as requiring the provision of inpatient coverage if 
     the attending physician in consultation with the patient 
     determine that a shorter period of hospital stay is medically 
     appropriate.
       ``(b) Reconstructive Surgery.--A group health plan, and a 
     health insurance issuer providing health insurance coverage 
     in connection with a group health plan, that provides medical 
     and surgical benefits with respect to a mastectomy shall 
     ensure that, in a case in which a mastectomy patient elects 
     breast reconstruction, coverage is provided for--
       ``(1) all stages of reconstruction of the breast on which 
     the mastectomy has been performed;
       ``(2) surgery and reconstruction of the other breast to 
     produce a symmetrical appearance; and
       ``(3) the costs of prostheses and complications of 
     mastectomy including lymphedemas;

     in the manner determined by the attending physician and the 
     patient to be appropriate. Such coverage may be subject to 
     annual deductibles and coinsurance provisions as may be 
     deemed appropriate and as are consistent with those 
     established for other benefits under the plan or coverage. 
     Written notice of the availability of such coverage shall be 
     delivered to the enrollee upon enrollment and annually 
     thereafter.
       ``(c) Notice.--A group health plan, and a health insurance 
     issuer providing health insurance coverage in connection with 
     a group health plan shall provide notice to each participant 
     and beneficiary under such plan regarding the coverage 
     required by this section in accordance with regulations 
     promulgated by the Secretary. Such notice shall be in writing 
     and prominently positioned in any literature or 
     correspondence made available or distributed by the plan or 
     issuer and shall be transmitted--
       ``(1) in the next mailing made by the plan or issuer to the 
     participant or beneficiary;
       ``(2) as part of any yearly informational packet sent to 
     the participant or beneficiary; or
       ``(3) not later than January 1, 1999;

     whichever is earlier.
       ``(d) No Authorization Required.--
       ``(1) In general.--An attending physician shall not be 
     required to obtain authorization from the plan or issuer for 
     prescribing any length of stay in connection with a 
     mastectomy, a lumpectomy, or a lymph node dissection for the 
     treatment of breast cancer.
       ``(2) Prenotification.--Nothing in this section shall be 
     construed as preventing a plan or issuer from requiring 
     prenotification of an inpatient stay referred to in this 
     section if such requirement is consistent with terms and 
     conditions applicable to other inpatient benefits under the 
     plan, except that the provision of such inpatient stay 
     benefits shall not be contingent upon such notification.
       ``(e) Prohibitions.--A group health plan, and a health 
     insurance issuer offering group health insurance coverage in 
     connection with a group health plan, may not--
       ``(1) deny to a patient eligibility, or continued 
     eligibility, to enroll or to renew coverage under the terms 
     of the plan, solely for the purpose of avoiding the 
     requirements of this section;
       ``(2) provide monetary payments or rebates to individuals 
     to encourage such individuals to accept less than the minimum 
     protections available under this section;
       ``(3) penalize or otherwise reduce or limit the 
     reimbursement of an attending provider because such provider 
     provided care to an individual participant or beneficiary in 
     accordance with this section;
       ``(4) provide incentives (monetary or otherwise) to an 
     attending provider to induce such provider to provide care to 
     an individual participant or beneficiary in a manner 
     inconsistent with this section; and
       ``(5) subject to subsection (f)(2), restrict benefits for 
     any portion of a period within a hospital length of stay 
     required under subsection (a) in a manner which is less 
     favorable than the benefits provided for any preceding 
     portion of such stay.
       ``(f) Rules of Construction.--
       ``(1) In general.--Nothing in this section shall be 
     construed to require a patient who is a participant or 
     beneficiary--
       ``(A) to undergo a mastectomy or lymph node dissection in a 
     hospital; or
       ``(B) to stay in the hospital for a fixed period of time 
     following a mastectomy or lymph node dissection.
       ``(2) Cost sharing.--Nothing in this section shall be 
     construed as preventing a group health plan or issuer from 
     imposing deductibles, coinsurance, or other cost-sharing in 
     relation to benefits for hospital lengths of stay in 
     connection with a mastectomy or lymph node dissection for the 
     treatment of breast cancer under the plan (or under health 
     insurance coverage offered in connection with a group health 
     plan), except that such coinsurance or other cost-sharing

[[Page S8507]]

     for any portion of a period within a hospital length of stay 
     required under subsection (a) may not be greater than such 
     coinsurance or cost-sharing for any preceding portion of such 
     stay.
       ``(3) Level and type of reimbursements.--Nothing in this 
     section shall be construed to prevent a group health plan or 
     a health insurance issuer offering group health insurance 
     coverage from negotiating the level and type of reimbursement 
     with a provider for care provided in accordance with this 
     section.
       ``(g) Preemption, Relation to State Laws.--
       ``(1) In general.--Nothing in this section shall be 
     construed to preempt any State law with respect to health 
     insurance coverage that--
       ``(A) relates to a hospital length of stay after a 
     mastectomy, lumpectomy, or lymph node dissection;
       ``(B) relates to coverage of reconstructive breast surgery 
     after a mastectomy, lumpectomy, or lymph node dissection; or
       ``(C) requires coverage for breast cancer treatments 
     (including breast reconstruction) in accordance with 
     scientific evidence-based practices or guidelines recommended 
     by established medical associations.
       ``(2) Application of section.--With respect to a State 
     law--
       ``(A) described in paragraph (1)(A), the provisions of this 
     section relating to breast reconstruction shall apply in such 
     State; and
       ``(B) described in paragraph (1)(B), the provisions of this 
     section relating to length of stays for surgical breast 
     treatment shall apply in such State.
       ``(3) Erisa.--Nothing in this section shall be construed to 
     affect or modify the provisions of section 514 with respect 
     to group health plans.''.
       (b) Effective Dates.--The amendments made by this section 
     shall apply to group health plans for plan years beginning on 
     or after the date of enactment of this Act.

     SEC. 535. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT RELATING 
                   TO THE INDIVIDUAL MARKET.

       (a) In General.--Subpart 3 of part B of title XXVII of the 
     Public Health Service Act (42 U.S.C. 300gg-51 et seq.), as 
     amended by section 303(b), is further amended by adding at 
     the end the following new section:

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

       ``The provisions of section 2707 shall apply to health 
     insurance coverage offered by a health insurance issuer in 
     the individual market in the same manner as they apply to 
     health insurance coverage offered by a health insurance 
     issuer in connection with a group health plan in the small or 
     large group market.''.
       (b) Effective Date.--The amendment made by this section 
     shall apply with respect to health insurance coverage 
     offered, sold, issued, renewed, in effect, or operated in the 
     individual market on or after the date of enactment of this 
     Act.

     SEC. 536. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.

       (a) In General.--Subchapter A of chapter 100 of the 
     Internal Revenue Code of 1986 (relating to group health plan 
     portability, access, and renewability requirements) is 
     amended by inserting after section 9803 the following new 
     section:

     ``SEC. 9804. REQUIRED COVERAGE FOR MINIMUM HOSPITAL STAY FOR 
                   MASTECTOMIES AND LYMPH NODE DISSECTIONS FOR THE 
                   TREATMENT OF BREAST CANCER AND COVERAGE FOR 
                   RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES.

       ``(a) Inpatient Care.--
       ``(1) In general.--A group health plan, and a health 
     insurance issuer providing health insurance coverage in 
     connection with a group health plan, that provides medical 
     and surgical benefits shall ensure that inpatient coverage 
     with respect to the surgical treatment of breast cancer 
     (including a mastectomy, lumpectomy, or lymph node dissection 
     for 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 scientific 
     evidence-based practices or guidelines, in consultation with 
     the patient, to be medically appropriate.
       ``(2) Exception.--Nothing in this section shall be 
     construed as requiring the provision of inpatient coverage if 
     the attending physician in consultation with the patient 
     determine that a shorter period of hospital stay is medically 
     appropriate.
       ``(b) Reconstructive Surgery.--A group health plan, and a 
     health insurance issuer providing health insurance coverage 
     in connection with a group health plan, that provides medical 
     and surgical benefits with respect to a mastectomy shall 
     ensure that, in a case in which a mastectomy patient elects 
     breast reconstruction, coverage is provided for--
       ``(1) all stages of reconstruction of the breast on which 
     the mastectomy has been performed;
       ``(2) surgery and reconstruction of the other breast to 
     produce a symmetrical appearance; and
       ``(3) the costs of prostheses and complications of 
     mastectomy including lymphedemas;

     in the manner determined by the attending physician and the 
     patient to be appropriate. Such coverage may be subject to 
     annual deductibles and coinsurance provisions as may be 
     deemed appropriate and as are consistent with those 
     established for other benefits under the plan or coverage. 
     Written notice of the availability of such coverage shall be 
     delivered to the participant upon enrollment and annually 
     thereafter.
       ``(c) Notice.--A group health plan, and a health insurance 
     issuer providing health insurance coverage in connection with 
     a group health plan shall provide notice to each participant 
     and beneficiary under such plan regarding the coverage 
     required by this section in accordance with regulations 
     promulgated by the Secretary. Such notice shall be in writing 
     and prominently positioned in any literature or 
     correspondence made available or distributed by the plan or 
     issuer and shall be transmitted--
       ``(1) in the next mailing made by the plan or issuer to the 
     participant or beneficiary;
       ``(2) as part of any yearly informational packet sent to 
     the participant or beneficiary; or
       ``(3) not later than January 1, 1999;

     whichever is earlier.
       ``(d) No Authorization Required.--
       ``(1) In general.--A, attending physician shall not be 
     required to obtain authorization from the plan or issuer for 
     prescribing any length of stay in connection with a 
     mastectomy, a lumpectomy, or a lymph node dissection for the 
     treatment of breast cancer.
       ``(2) Prenotification.--Nothing in this section shall be 
     construed as preventing a plan or issuer from requiring 
     prenotification of an inpatient stay referred to in this 
     section if such requirement is consistent with terms and 
     conditions applicable to other inpatient benefits under the 
     plan, except that the provision of such inpatient stay 
     benefits shall not be contingent upon such notification.
       ``(e) Prohibitions.--A group health plan, and a health 
     insurance issuer offering group health insurance coverage in 
     connection with a group health plan, may not--
       ``(1) deny to a patient eligibility, or continued 
     eligibility, to enroll or to renew coverage under the terms 
     of the plan, solely for the purpose of avoiding the 
     requirements of this section;
       ``(2) provide monetary payments or rebates to individuals 
     to encourage such individuals to accept less than the minimum 
     protections available under this section;
       ``(3) penalize or otherwise reduce or limit the 
     reimbursement of an attending provider because such provider 
     provided care to an individual participant or beneficiary in 
     accordance with this section;
       ``(4) provide incentives (monetary or otherwise) to an 
     attending provider to induce such provider to provide care to 
     an individual participant or beneficiary in a manner 
     inconsistent with this section; and
       ``(5) subject to subsection (f)(2), restrict benefits for 
     any portion of a period within a hospital length of stay 
     required under subsection (a) in a manner which is less 
     favorable than the benefits provided for any preceding 
     portion of such stay.
       ``(f) Rules of Construction.--
       ``(1) In general.--Nothing in this section shall be 
     construed to require a patient who is a participant or 
     beneficiary--
       ``(A) to undergo a mastectomy or lymph node dissection in a 
     hospital; or
       ``(B) to stay in the hospital for a fixed period of time 
     following a mastectomy or lymph node dissection.
       ``(2) Cost sharing.--Nothing in this section shall be 
     construed as preventing a group health plan or issuer from 
     imposing deductibles, coinsurance, or other cost-sharing in 
     relation to benefits for hospital lengths of stay in 
     connection with a mastectomy or lymph node dissection for the 
     treatment of breast cancer under the plan (or under health 
     insurance coverage offered in connection with a group health 
     plan), except that such coinsurance or other cost-sharing for 
     any portion of a period within a hospital length of stay 
     required under subsection (a) may not be greater than such 
     coinsurance or cost-sharing for any preceding portion of such 
     stay.
       ``(3) Level and type of reimbursements.--Nothing in this 
     section shall be construed to prevent a group health plan or 
     a health insurance issuer offering group health insurance 
     coverage from negotiating the level and type of reimbursement 
     with a provider for care provided in accordance with this 
     section.
       ``(g) Preemption, Relation to State Laws.--
       ``(1) In general.--Nothing in this section shall be 
     construed to preempt any State law with respect to health 
     insurance coverage that--
       ``(A) relates to a hospital length of stay after a 
     mastectomy, lumpectomy, or lymph node dissection;
       ``(B) relates to coverage of reconstructive breast surgery 
     after a mastectomy, lumpectomy, or lymph node dissection; or
       ``(C) requires coverage for breast cancer treatments 
     (including breast reconstruction) in accordance with 
     scientific evidence-based practices or guidelines recommended 
     by established medical associations.
       ``(2) Application of section.--With respect to a State 
     law--
       ``(A) described in paragraph (1)(A), the provisions of this 
     section relating to breast reconstruction shall apply in such 
     State; and
       ``(B) described in paragraph (1)(B), the provisions of this 
     section relating to length of stays for surgical breast 
     treatment shall apply in such State.
       ``(3) Erisa.--Nothing in this section shall be construed to 
     affect or modify the provisions of section 514 with respect 
     to group health plans.''.

[[Page S8508]]

       (b) Conforming Amendments.--
       (1) The heading for subtitle K of such Code is amended to 
     read as follows:

``Subtitle K--Group Health Plan Portability, Access, Renewability, and 
                         Other Requirements''.

       (2) The heading for chapter 100 of such Code is amended to 
     read as follows:

``CHAPTER 100--GROUP HEALTH PLAN PORTABILITY, ACCESS, RENEWABILITY, AND 
                         OTHER REQUIREMENTS''.

       (3) Section 4980D(a) of such Code is amended by striking 
     ``and renewability'' and inserting ``renewability, and 
     other''.
       (c) Clerical Amendments.--
       (1) The table of contents for chapter 100 of such Code is 
     amended inserting after the item relating to section 9803 the 
     following new item:

``Sec. 9804. Required coverage for minimum hospital stay for 
              mastectomies and lymph node dissections for the treatment 
              of breast cancer and coverage for reconstructive surgery 
              following mastectomies.''.

       (2) The item relating to subtitle K in the table of 
     subtitles for such Code is amended by striking ``and 
     renewability'' and inserting ``renewability, and other''.
       (3) The item relating to chapter 100 in the table of 
     chapters for subtitle K of such Code is amended by striking 
     ``and renewability'' and inserting ``renewability, and 
     other''.
       (d) Effective Dates.--The amendments made by this section 
     shall apply with respect to plan years beginning on or after 
     the date of enactment of this Act.

     SEC. 537. RESEARCH STUDY ON THE MANAGEMENT OF BREAST CANCER.

       (a) Study.--To improve survival, quality of life and 
     patient satisfaction in the care of patients with breast 
     cancer, the Agency for Health Care Policy and Research shall 
     conduct a study of the scientific issues relating to--
       (1) disease management strategies for breast cancer that 
     can achieve better patient outcomes;
       (2) controlled clinical evidence that links specific 
     clinical procedures to improved health outcomes;
       (3) the definition of quality measures to evaluate plan and 
     provider performance in the management of breast cancer;
       (4) the identification of quality improvement interventions 
     that can change the process of care to achieve better 
     outcomes for individuals with breast cancer;
       (5) preventive strategies utilized by health plans for the 
     treatment of breast cancer; and
       (6) the extent of clinical practice variation including its 
     impact on cost, quality and outcomes.
       (b) Report.--Not later than January 1, 2000, the Agency for 
     Health Care Policy and Research shall prepare and submit to 
     the appropriate committees of Congress a report concerning 
     the results of the study conducted under subsection (a).

         TITLE VI--ENHANCED ACCESS TO HEALTH INSURANCE COVERAGE

     SEC. 601. CARRYOVER OF UNUSED BENEFITS FROM CAFETERIA PLANS, 
                   FLEXIBLE SPENDING ARRANGEMENTS, AND HEALTH 
                   FLEXIBLE SPENDING ACCOUNTS.

       (a) In General.--Section 125 of the Internal Revenue Code 
     of 1986 (relating to cafeteria plans) is amended by 
     redesignating subsections (h) and (i) as subsections (i) and 
     (j) and by inserting after subsection (g) the following new 
     subsection:
       ``(h) Allowance of Carryovers of Unused Benefits to Later 
     Taxable Years.--
       ``(1) In general.--For purposes of this title--
       ``(A) a plan or other arrangement shall not fail to be 
     treated as a cafeteria plan or flexible spending or similar 
     arrangement, and
       ``(B) no amount shall be required to be included in gross 
     income by reason of this section or any other provision of 
     this chapter,

     solely because under such plan or other arrangement any 
     nontaxable benefit which is unused as of the close of a 
     taxable year may be carried forward to 1 or more succeeding 
     taxable years.
       ``(2) Limitation.--Paragraph (1) shall not apply to amounts 
     carried from a plan to the extent such amounts exceed $500 
     (applied on an annual basis). For purposes of this paragraph, 
     all plans and arrangements maintained by an employer or any 
     related person shall be treated as 1 plan.
       ``(3) Allowance of rollover.--
       ``(A) In general.--In the case of any unused benefit 
     described in paragraph (1) which consists of amounts in a 
     health flexible spending account or dependent care flexible 
     spending account, the plan or arrangement shall provide that 
     a participant may elect, in lieu of such carryover, to have 
     such amounts distributed to the participant.
       ``(B) Amounts not included in income.--Any distribution 
     under subparagraph (A) shall not be included in gross income 
     to the extent that such amount is transferred in a trustee-
     to-trustee transfer, or is contributed within 60 days of the 
     date of the distribution, to--
       ``(i) an individual retirement plan other than a Roth IRA 
     (as defined in section 408A(b)),
       ``(ii) a qualified cash or deferred arrangement described 
     in section 401(k),
       ``(iii) a plan under which amounts are contributed by an 
     individual's employer for an annuity contract described in 
     section 403(b),
       ``(iv) an eligible deferred compensation plan described in 
     section 457, or
       ``(v) a medical savings account (within the meaning of 
     section 220).

     Any amount rolled over under this subparagraph shall be 
     treated as a rollover contribution for the taxable year from 
     which the unused amount would otherwise be carried.
       ``(C) Treatment of rollover.--Any amount rolled over under 
     subparagraph (B) shall be treated as an eligible rollover 
     under section 219, 220, 401(k), 403(b), or 457, whichever is 
     applicable, and shall not be taken into account in applying 
     any limitation (or participation requirement) on employer or 
     employee contributions under such section or any other 
     provision of this chapter for the taxable year of the 
     rollover.
       ``(4) Cost-of-living adjustment.--In the case of any 
     taxable year beginning in a calendar year after 1998, the 
     $500 amount under paragraph (2) shall be adjusted at the same 
     time and in the same manner as under section 415(d)(2), 
     except that the base period taken into account shall be the 
     calendar quarter beginning October 1, 1997, and any increase 
     which is not a multiple of $50 shall be rounded to the next 
     lowest multiple of $50.''
       (b) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     1998.

     SEC. 602. FULL DEDUCTION OF HEALTH INSURANCE COSTS FOR SELF-
                   EMPLOYED INDIVIDUALS.

       (a) In General.--Section 162(l)(1) of the Internal Revenue 
     Code of 1986 (relating to allowance of deductions) is amended 
     to read as follows:
       ``(1) Allowance of deduction.--In the case of an individual 
     who is an employee within the meaning of section 401(c)(1), 
     there shall be allowed as a deduction under this section an 
     amount equal to the amount paid during the taxable year for 
     insurance which constitutes medical care for the taxpayer, 
     his spouse, and his dependents.''
       (b) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     1998.

     SEC. 603. FULL AVAILABILITY OF MEDICAL SAVINGS ACCOUNTS.

       (a) Availability Not Limited To Accounts for Employees of 
     Small Employers and Self-Employed Individuals.--
       (1) In general.--Section 220(c)(1)(A) of the Internal 
     Revenue Code of 1986 (relating to eligible individual) is 
     amended to read as follows:
       ``(A) In general.--The term `eligible individual' means, 
     with respect to any month, any individual if--
       ``(i) such individual is covered under a high deductible 
     health plan as of the 1st day of such month, and
       ``(ii) such individual is not, while covered under a high 
     deductible health plan, covered under any health plan--

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

       (2) Conforming amendments.--
       (A) Section 220(c)(1) of such Code is amended by striking 
     subparagraphs (C) and (D).
       (B) Section 220(c) of such Code is amended by striking 
     paragraph (4) (defining small employer) and by redesignating 
     paragraph (5) as paragraph (4).
       (C) Section 220(b) of such Code is amended by striking 
     paragraph (4) (relating to deduction limited by compensation) 
     and by redesignating paragraphs (5), (6), and (7) as 
     paragraphs (4), (5), and (6), respectively.
       (b) Removal of Limitation on Number of Taxpayers Having 
     Medical Savings Accounts.--
       (1) In general.--Section 220 of the Internal Revenue Code 
     of 1986 (relating to medical savings accounts) is amended by 
     striking subsections (i) and (j).
       (2) Medicare+choice.--Section 138 of such Code (relating to 
     Medicare+Choice MSA) is amended by striking subsection (f).
       (c) Reduction in High Deductible Plan Minimum Annual 
     Deductible.--Section 220(c)(2)(A) of the Internal Revenue 
     Code of 1986 (relating to high deductible health plan) is 
     amended--
       (1) by striking ``$1,500'' in clause (i) and inserting 
     ``$1,000'', and
       (2) by striking ``$3,000'' in clause (ii) and inserting 
     ``$2,000''.
       (d) Increase in Contribution Limit to 100 Percent of Annual 
     Deductible.--
       (1) In general.--Section 220(b)(2) of the Internal Revenue 
     Code of 1986 (relating to monthly limitation) is amended to 
     read as follows:
       ``(2) Monthly limitation.--The monthly limitation for any 
     month is the amount equal to \1/12\ of the annual deductible 
     of the high deductible health plan of the individual.''
       (2) Conforming amendment.--Section 220(d)(1)(A) of such 
     Code is amended by striking ``75 percent of''.
       (e) Limitation on Additional Tax on Distributions Not Used 
     for Qualified Medical Expenses.--Section 220(f)(4) of the 
     Internal Revenue Code of 1986 (relating to additional tax on 
     distributions not used for qualified medical expenses) is 
     amended by adding at the end the following:
       ``(D) Exception in Case of Sufficient Account Balance.--
     Subparagraph (A) shall not apply to any payment or 
     distribution in any taxable year, but only to the extent such 
     payment or distribution does not reduce the fair market value 
     of the assets of the medical savings account to an amount 
     less than the annual deductible for the high deductible

[[Page S8509]]

     health plan of the account holder (determined as of January 1 
     of the calendar year in which the taxable year begins).''.
       (f) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     1998.

     SEC. 604. PERMITTING CONTRIBUTION TOWARDS MEDICAL SAVINGS 
                   ACCOUNT THROUGH FEDERAL EMPLOYEES HEALTH 
                   BENEFITS PROGRAM (FEHBP).

       (a) Government Contribution to Medical Savings Account.--
       (1) In general.--Section 8906 of title 5, United States 
     Code, is amended by adding at the end the following:
       ``(j)(1) In the case of an employee or annuitant who is 
     enrolled in a catastrophic plan described by section 8903(5), 
     there shall be a Government contribution under this 
     subsection to a medical savings account established or 
     maintained for the benefit of the individual. The 
     contribution under this subsection shall be in addition to 
     the Government contribution under subsection (b).
       ``(2) The amount of the Government contribution under this 
     subsection with respect to an individual is equal to the 
     amount by which--
       ``(A) the maximum contribution allowed under subsection 
     (b)(1) with respect to any employee or annuitant, exceeds
       ``(B) the amount of the Government contribution actually 
     made with respect to the individual under subsection (b) for 
     coverage under the catastrophic plan.
       ``(3) The Government contributions under this subsection 
     shall be paid into a medical savings account (designated by 
     the individual involved) in a manner that is specified by the 
     Office and consistent with the timing of contributions under 
     subsection (b).
       ``(4) Subsections (f) and (g) shall apply to contributions 
     under this section in the same manner as they apply to 
     contributions under subsection (b).
       ``(5) For the purpose of this subsection, the term `medical 
     savings account' has the meaning given such term by section 
     220(d) of the Internal Revenue Code of 1986.''.
       (2) Allowing payment of full amount of charge for 
     catastrophic plan.--Section 8906(b)(2) of such title is 
     amended by inserting ``(or 100 percent of the subscription 
     charge in the case of a catastrophic plan)'' after ``75 
     percent of the subscription charge''.
       (b) Offering of Catastrophic Plans.--
       (1) In general.--Section 8903 of title 5, United States 
     Code, is amended by adding at the end the following:
       ``(5) Catastrophic plans.--One or more plans described in 
     paragraph (1), (2), or (3), but which provide benefits of the 
     types referred to by paragraph (5) of section 8904(a), 
     instead of the types referred to in paragraphs (1), (2), and 
     (3) of such section.''.
       (2) Types of benefits.--Section 8904(a) of such title is 
     amended by inserting after paragraph (4) the following new 
     paragraph:
       ``(5) Catastrophic plans.--Benefits of the types named 
     under paragraph (1) or (2) of this subsection or both, to the 
     extent expenses covered by the plan exceed $500.''.
       (3) Disregarding catastrophic plans in determining level of 
     government contributions.--Section 8906(a)(3) of such title 
     is amended by inserting ``described by section 8903(3)'' 
     after ``plans''.
       (c) Effective Date.--The amendments made by this section 
     shall apply to contract terms beginning on or after January 
     1, 1999.

  Mr. FRIST. Mr. President, I am pleased to rise today to introduce the 
``Patients' Bill of Rights'' with my colleague from Oklahoma, Senator 
Don Nickles, the members of the Senate Republican Task Force on Health 
Care Quality, and our distinguished Majority Leader, Senator Trent 
Lott.
  This bill is a product of several months of thoughtful discussion and 
debate among Republican members to reach a consensus proposal to 
improve health care quality.
  As a physician who has practiced medicine for twenty years, I know 
that health care is delivered best when the relationship between doctor 
and patient is given the highest priority. My goal is to provide the 
necessary support to empower doctors and patients to make important 
health care decisions.
  This proposal includes a ``Patients' Bill of Rights'' which offers 
protection for patients by insuring them full access to information 
about their health plan; making sure patients receive necessary 
emergency care; allowing patients to keep their doctor during a 
pregnancy or extended illness, even if their doctor is dropped by their 
plan; and allowing patients direct access to obstetric and 
gynecological care and pediatric care without having to obtain a 
referral from a gatekeeper.
  Many consumers fear that their health care plans will not give them 
access to care when they need it most, that they will be denied the 
benefits they have paid for and been promised, and that their health 
plans care more about cost than they do about quality. A critical 
measure of this bill is to hold health plans accountable for the 
coverage decisions they make and to take the power of denial of care 
out of the hands of HMOs and place it in the hands of independent 
medical experts. Our bill requires health plans to make coverage 
determinations in less than 72 hours if a doctor determines that 
further delay could jeopardize the life or health of a patient. We want 
to protect patients before harm occurs by setting up a process for 
patients and their families to get an immediate answer. Furthermore, we 
require health plans to provide quick internal grievance and 
independent external appeals processes in cases where a plan may deny 
coverage for necessary medical action or because it is an experimental 
procedure.
  Our bill fills a need by providing protections for patients who rely 
on plans that states cannot touch. Our bill provides independent review 
of health plans for 125 million Americans without lining the pockets of 
trial lawyers in the process. Further litigation serves to divert 
billions of dollars away from health care and puts in the pockets of 
trial lawyers.
  Our bill guarantees patients the right to have access to their own 
medical information and the right to amend their medical information if 
mistakes are made. We require health plans to inform a patient of the 
plan's practices to protect the confidentiality of their medical record 
and requires health plans to establish safeguards to protect the 
confidentiality and security of health information.
  Our bill has a strong focus on quality and a firm commitment to 
improve quality. Some believe that quality can be legislated. Some here 
in Washington believe they know how to define quality. Yet the risk of 
writing today's concept of quality into law, is that it is an evolving 
science and if we are too rigid, we fail to capture the innovation that 
improves quality of care and our ability to measure it.
  Our legislation promotes quality improvement by supporting research 
to give patients and physicians better information regarding quality. 
The ``Patients' Bill of Rights'' establishes an Agency for Health Care 
Quality Research (AHQR), whose purpose is to foster overall improvement 
in health care quality through supporting pertinent research and 
disseminating information. The Agency is built on the platform of the 
current Agency for Health Care Policy and Research, but is refocused 
and enhanced to become the hub and driving force of federal efforts to 
improve quality of health care in all practice environments--from 
managed care to solo private practice, from urban to rural settings, 
and from federal to non-federal programs.
  The role of the Agency is not to mandate a national definition of 
quality, but to support the science necessary to provide information to 
patients regarding the quality of the care they receive; to allow 
physicians to compare their quality outcomes with their peers; and to 
enable employers and individuals to be prudent purchasers based on 
quality.
  The new Agency will build public-private partnerships to advance and 
share quality measures. Quality means different things to different 
people. Therefore, in collaboration with the private sector, the Agency 
shall conduct research that can figure out what quality really means to 
patients and clinicians, how to measure quality, and what actions can 
improve care.
  It will promote quality by sharing information. While proven medical 
advances are made daily, patients wait too long to benefit from these 
discoveries. We must get the science to the people by better sharing of 
information and more effective dissemination. The Agency is required to 
develop evidence-rating systems to help people judge the quality of 
science.
  The Agency plays an important role in facilitating innovation in 
patient care with streamlined assessment of new technologies. Patients 
should benefit from breakthrough technologies sooner, while inefficient 
methods should be phased out faster. The Agency will be accessible to 
both private and public entities for technology assessments and will 
share information on assessment methodologies.
  Currently, quality measurement too often requires manual chart 
reviews for such simple data as frequently of procedures, infection 
rates, or other complications. Improved computer systems will advance 
quality scoring and facilitate decision-making in patient care.

[[Page S8510]]

The Agency will aggressively support the development of state-of-the-
art information systems systems for health care quality.
  While most policy discussions this year are targeting managed care, 
quality improvement is just as important to the solo private 
practitioner. The Agency will focus on primary care delivery research 
to examine how science is translated in the doctor's office. The agency 
will specifically address quality in rural and other underserved areas 
by advancing telemedicine services and other distance technologies.
  Most of the many federal health care programs today support some kind 
of health services research and conduct various quality improvement 
projects. The Agency shall coordinate these initiatives to avoid 
disjointed, uncoordinated, or duplicative efforts.
  Finally, this debate is due to the fact that patients want to know if 
they receive quality health care. But compared to what? Statistically 
accurate, sample-based national surveys will efficiently provide 
reliable and affordable data--without excessive, overly intrusive, and 
potentially destructive, mandatory reporting requirements. This is 
accomplished through an expansion of the current Medical Expenditure 
Panel Survey to require that outcomes be measured and reported to 
Congress so the public may better determine the state of quality, and 
cost, of the nation's health care.
  The role of the AHQR is not to mandate national standards of clinical 
practice. Definitions and measures of quality are an evolving science, 
a science critically important to making educated and appropriate 
choices in a rapidly changing and dynamic health care system. This bill 
will go a long way in bridging the gap between what we know and what we 
do in health care today.
  The bill we are introducing today has a strong focus on women's 
health issues. On March 6, 1998, I introduced S. 1722, the ``Women's 
Health Research and Prevention Amendments of 1998'' with our Majority 
Leader, Senator Trent Lott, to increase awareness of some of the most 
pressing diseases and health issues that women in our country face. 
These provisions, which have been included in the Patients' Bill of 
Rights Act, focus on women's health research and prevention activities 
at the National Institutes of Health and the Centers for Disease 
Control and Prevention. The goal of these provisions is to create 
greater awareness of women's health issues and to highlight the 
critical role our public health agencies, the NIH and CDC, play in 
providing a broad spectrum of activities to improve women's health--
including research, screening, prevention, treatment, education, and 
data collection.
  Among others, these provisions promote basic and clinical research 
for osteoporosis and breast and ovarian cancer. We expand our research 
efforts into the underlying causes and prevention of cardiovascular 
diseases in women--the leading cause of death in U.S. women. The bill 
reauthorizes the National Breast and Cervical Cancer Screening Program 
which provides for crucial screening services for breast and cervical 
cancers to underserved women and supports data collection through the 
National Center for Health Statistics and the National Program of 
Cancer Registries which are the leading sources of national data on the 
health status of U.S. women.
  The reauthorization of these research programs will help assure 
scientific progress in our fight against these diseases and will lessen 
their burden on women and their families. We have the support of nearly 
the full Senate Labor and Human Resources committee and many members of 
the United States Senate from both sides of the aisle for these 
provisions. The level of support for these programs is a testament to 
the need to combat the disease affecting women and to maintain the 
crucial health services that help prevent these diseases.
  One of the provisions I am most proud to include in this bill is the 
prohibition on genetic discrimination in healthy insurance practices. 
We as a nation must face the fear of discrimination in health insurance 
practices based on our increasing ability to gather genetic information 
about ourselves and our families. Our ability to predict what diseases 
individuals may be at risk for in the future has caused great concern 
that this powerful information--the information we all carry in our 
genes--may be used against us.
  I am deeply troubled when I hear from the Tennessee Breast Cancer 
Coalition that genetic counselors are facing women everyday who are 
afraid of the consequences of genetic testing. Women are avoiding 
genetic testing due to concerns about loss of health insurance coverage 
for themselves or their families--even though a genetic test might 
reveal that a woman is not at high risk and therefore allow her to make 
more informed health care choices.
  I am a strong advocate for legislation which would prohibit 
discrimination in health insurance against healthy individuals and 
their families based on their genetic information. We all carry genetic 
mutations that may place us at risk for future disease--therefore we 
are all at risk for discrimination. If I receive a genetic test which 
shows I am at risk for cancer, diabetes, or heart disease, should this 
predictive information be used against me or my family? Particularly 
when I am currently healthy and, in fact, may never develop the 
illness? I think the American public has answered quite clearly, 
``no.''
  The Senate Republican Task Force made the same decision to say 
``no.'' Not only are we addressing the rights of patients today--but we 
are thinking forward to future concerns of patients. I must commend the 
efforts of my colleague Senator Snowe whose original bill, S. 89, has 
provided a framework and the sound principles for the basis of the 
legislation. She has supported the Task Force effort and worked with us 
step by step to craft this legislation. I must also commend the members 
of the Task Force, particularly Senator Jeffords, who had the foresight 
to include these provisions.
  Our bill prohibits health insurers from collecting genetic 
information about a patient; prohibits health insurers from using 
predictive genetic information to deny coverage; prohibits health 
insurers from using predictive genetic information in setting premiums 
or rates; and requires health insurers to inform patients of the health 
plans' confidentiality practices and safeguards in place if a patient 
wishes to disclose genetic information for purposes of treatment.
  Preventing genetic discrimination has enormous implications for 
improving the quality of care patients receive. As a physician and 
researcher, I am particularly concerned that the fear of discrimination 
will prevent individuals from participating in research studies and 
therefore hinder the scientific answers we need which hold the promise 
of higher quality medical care. I am concerned that individuals feel 
safe taking advantage of new genetic technologies to improve their 
medical care.
  The goal of our bill is to provide the public with peace of mind. If 
families or individuals want to undergo genetic testing, this bill will 
ensure that insurance companies cannot discriminate based on this 
information. We must act now. Only with these measures can we ensure 
that knowledge about our genetic heritage will be used to improve our 
health--and not force us to hide in fear that this information will 
cause us harm.
  Finally, our bill enhances access and choice of health insurance 
coverage by increasing access to and affordability of health care. The 
bill includes provisions to allow self-employed individuals to fully 
deduct their health care expenses; provides greater flexibility to 
employees who utilize flexible spending accounts to pay for health 
care; and gives incentives to individuals to have control over their 
health care decisions and costs through expansion of the use of Medical 
Savings Accounts. This option will allow a patient to access the 
physician of their choice and choose the medical treatment they need 
without any interference from a gatekeeper.
  The ``Patient's Bill of Rights'' offers all Americans: quality 
improvement built on a foundation of science, patient protection to 
access the care they need from the provider of choice, trust in the 
health care delivery system, and access to affordable health insurance 
coverage. I am pleased that this bill represents a forward-looking 
approach to provide for continuous improvement in health care quality. 
It meets our goal of assuring that the doctor and patient define 
quality, not HMOs, not bureaucrats and not trial attorneys.

[[Page S8511]]

  Mr. JEFFORDS. Mr. President, I want to begin by commending Senator 
Nickles and all of the Members who participated in putting the 
``Patients' Bill of Rights'' legislation together. I think it is solid 
legislation that will result in a greatly improved health care system 
for Americans and I am proud to be a co-sponsor of the ``Patients' Bill 
of Rights.''
  As always, there has been a flurry of work over the past few weeks as 
we have put this legislation together. But this last minute work is 
only possible because we have laid a solid foundation throughout the 
entire 105th Congress.
  Over the past 14 months, the Labor and Human Resources Committee has 
held 11 hearings related to the issues of health care quality, 
confidentiality, genetic discrimination and the Health Care Financing 
Administration's (HCFA) implementation of its new health insurance 
responsibilties. Senator Bill Frist's Public Health and Safety 
Subcommittee has also held three hearings on the work of the Agency of 
Health Care Policy and Research (AHCPR). Each of these hearings helped 
us in developing the separate pieces of legislation that are reflected 
in our ``Patients'' Bill of Rights.''
  Other colleagues here and on the House side, have worked ont this 
subject for an extended period of time. Many of the protections that 
are included in the ``Patients' Bill of Rights'' are similar to those 
fashioned by Senator Roth and the Finance Committee last year when we 
provided many of these same protections to plans that serve Medicare 
patients.
  As we prepared this legislation we had three goals in mind. First, 
give families the protections they want and need. Second, ensure that 
medical decisions are made by physicians in consultation with their 
patients. And finally, keep the cost of this legislation low so it does 
not displace anyone from being able to get health-care coverage.
  Information about products or services is the keystone to any well 
functioning market. This bill requires full information disclosure by 
an employer about the health plans he or she offers to employees. 
People need to know what the plan will cover and what their out-of-
pocket expenses will be. They need to know where and how they will get 
their health care and who will be providing those services. They also 
need to know how adverse decisions by the plan can be appealed, both 
internally and externally to an independent reviewer.
  This aspect of our bill, that gives enrollees a new ERISA remedy of 
an external grievance and appeals process, is one of which I am 
particularly proud since it is the cornerstone of S 1712, the Health 
Care QUEST Act, that I introduced with Senator Lieberman. Under the 
``Patients' Bill of Rights,'' enrollees will get timely decisions about 
what will be covered. Furthermore, if an individual disagrees with the 
plan's decision, that individual may ultimately appeal the decision to 
an independent external reviewer. The reviewer's decision will be 
binding on the part of the health plan. But, the patient maintains his 
or her current rights under ERISA to go to court.
  The medical records provisions, which my committee has also worked on 
for the past year and are contained in S. 1921, the Health Care PIN 
Act, which I introduced with Senator Dodd, will give people the right 
to inspect and copy their personal medical information and it will 
allow them to amend the record if there is inaccurate information. The 
bill will ensure that the holders of the information safeguard the 
medical records. It requires them to share, in writing, their 
confidentiality policies and procedures with individuals.
  The 104th Congress enacted the Kassebaum/Kennedy legislation, also 
known as the Health Insurance Portability and Accountability Act of 
1996 (HIPAA) Many consider this legislation to be the most significant 
federal health insurance reform of the past decade. During this 
Congress, I have tried to closely monitor the impact of HIPAA over the 
past year to ensure its successful implementation and consistency with 
legislative intent.
  The federal regulators at HCFA have faced an overwhelming new set of 
health insurance duties under HIPAA. In the five states that have 
failed to or chosen not to pass the legislation required by HIPAA 
(California, Massachusetts, Michigan, Rhode Island, and Missouri), the 
Department of Health and Human Services is now required to act as 
insurance regulator for the state HIPAA provisions.
  Based on the findings of a GAO report that I will be releasing next 
week, our experience under HIPAA demonstrates that HCFA is ill equipped 
to carry out the role of insurance regulator. Building a dual system of 
overlapping state and federal health insurance regulation is in no 
one's best interest. The principle that the states should continue to 
regulate the private health insurance market guided the design of our 
``Patients' Bill of Rights'' legislation.
  Our legislation creates new federal managed care standards to cover 
those 48 million Americans covered by ERISA plans that the states 
cannot protect. We feel that it would be inappropriate to set federal 
health insurance standards that duplicate the responsibility of the 50 
state insurance departments and have HCFA enforce them.
  A recent example demonstrates why this is such a concern. The 
Balanced Budget Act of 1997 establishes a prospective payment system 
(PPS) for home health care in fiscal year 2000. The payment system 
designed for the interim period is proving to be an intolerable burden 
for the home health agencies that serve Vermont's Medicare 
beneficiaries. At a July 16th House Ways and Means hearing, HCFA's 
administrator stated that she intended to postpone the development of a 
Medicare prospective payment systems for home health services. Her 
statement that she is delaying this mandate will result in many home 
health providers not receiving the reimbursement that they deserve and 
puts many of those providers at risk.
  Given HCFA's inability to carry out its current responsibilities, I 
believe it would be irresponsible to promise the American people that 
they will be able to receive new federal guarantees in the private 
health insurance system if we are relying on HCFA to enforce these 
rights.
  Our proposal, by keeping the regulation of health insurance where it 
belongs--at the state level--provides the American people with a real 
Patients' Bill of Rights that they can have the confidence in knowing 
will be enforced.
  I am afraid that the political battle over this legislation will be 
the subject that dominates the headlines. But the real issue here is to 
give Americans the protections they want and need in a package that 
they can afford and that we can enact. That is why I and others here 
have been working on this legislation since the beginning of this 
Congress, and why I hope the ``Patients' Bill of Rights'' we have 
introduced today will be adopted before the end of the Congress and 
signed into law by the President.
                                 ______