[Congressional Record Volume 145, Number 11 (Friday, January 22, 1999)]
[Senate]
[Pages S902-S922]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. LOTT (for himself, Mr. Nickles, Ms. Collins, Mr. Frist, 
        Mr. Gramm, Mr. Hagel, Mr. Jeffords, Mr. Roth, Mr. Santorum, Mr. 
        Mack, Mr. Craig, Mr. Coverdell, Mr. McConnell, Mr. Abraham, Mr. 
        Allard, Mr. Ashcroft, Mr. Bennett, Mr. Bond, Mr. Brownback, Mr. 
        Bunning, Mr. Burns, Mr. Campbell, Mr. Cochran, Mr. DeWine, Mr. 
        Domenici, Mr. Enzi, Mr. Gorton, Mr. Grams, Mr. Grassley, Mr. 
        Gregg, Mr. Hatch, Mr. Helms, Mr. Hutchinson, Mrs. Hutchison, 
        Mr. Inhofe, Mr. Lugar, Mr. McCain, Mr. Murkowski, Mr. Roberts, 
        Mr. Sessions, Mr. Shelby, Mr. Smith of New Hampshire, Mr. Smith 
        of Oregon, Ms. Snowe, Mr. Stevens, Mr. Thomas, Mr. Thompson, 
        Mr. Thurmond, Mr. Voinovich, and Mr. Warner):
  S. 300. A bill to improve access and choice of patients to quality, 
affordable health care; to the Committee on Health, Education, Labor, 
and Pensions.


                   Patients' Bill of Rights Plus Act

 Mr. NICKLES. Mr. President, today I am introducing the Senate 
Republican Patients' Bill of Rights Plus. Joining me in this effort are 
49 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 the highest quality of care available. The 
foundation of this proposal is to address some of the very real 
concerns that patients have about their health care needs and to 
provide significant opportunities for all consumers in choosing their 
doctors and health plans.
  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.
  Last January, the Majority Leader asked me to put together a group of 
colleagues to address the issue of health care quality. For over eight 
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.
  Together, we have written 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. After all, 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 unencum- bered 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. In addition our legislation does what no other bill has 
done. It provides the patient with more choice in their health plans.
  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. Guarantees 
parents and families peace of mind by giving 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. Our bill 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, 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.

[[Page S903]]

  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 Health- care 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.
  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 flexibility spending accounts 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. This legislation is built around several 
basic principles which distinguishes it from other proposals.
  First and foremost, it recognizes that regulation adds costs and not 
value. The legislation places a priority on ensuring that we will not 
increase the number of uninsured or make health care unaffordable 
through excessive regulation.
  Second, our legislation rightly places patients ahead of trial 
lawyers. The inclusion of a strong, internal and external appeals 
provision holds HMOs accountable, while guaranteeing that patients get 
the care they need when they need it.
  Third, our legislation protects the historic and traditional role of 
states to regulate private health insurance. States are best equipped 
to determine the needs of their citizens. Our legislation ensures that 
the Federal Government and HCFA will not be empowered to expand their 
reach into the private market. The creation of new federal 
bureaucracies will only serve to stagnate and destroy what is best 
about our health care system.
  Finally, our legislation places a high priority on choice. Unlike 
every other proposal our bill will give every American the right to 
fire their HMO. Every patient will have their choice of doctor and 
health plan.
  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 professional 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.
  Other bills create 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 25 months--more than two years--to resolve a malpractice suit. 
One case 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. 
It does not divert dollars away from patients and into the pockets of 
trial lawyers.
  Mr. President, another big difference between our bill and others 
proposed is that their bill takes a ``big government'' approach to 
health reform.
  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.
  Another problem: Some bills impose 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, 1998, a GAO witness testified before the Ways and Means 
Committee on how well HCFA was doing in implementing the Balanced 
Budget Act and 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 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 tool-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 pricey sum of 
$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 protect the rights of 
38.5 million Medicare beneficiaries, how can we ask it to protect the 
rights of up to 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.
  One just has to look at HCFAs record on the Health Insurance and 
Portability and Accountability Act

[[Page S904]]

(HIPAA). This Act gave HCFA enforcement authority in states that do not 
meet federal health standards. But how has HCFA done in the enforcement 
of HIPAA? A GAO report analyzing HCFA's success states that HCFA has 
done very little in this area. HCFA's activities, to date, have been 
``limited primarily to responding to consumer queries and complaints 
and providing guidance'' to carriers in 4 of the 5 states that are not 
in compliance.
  The GAO report goes on to say that even HCFA admits ``the agency has 
thus far pursued a ``Band Aid'' or minimalist approach to regulating 
HIPAA. The failure to fully address this regulatory responsibility is 
due to the fact that HCFA lacks the ``appropriate experience'' in the 
regulating of the private health insurance market.
  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 to a deliberative, thoughtful process this year on 
examining the complex issues addressed in our Patients Bill of Rights 
PLUS. Last year, the debate surrounding this legislation was extremely 
politicized and resulted in a partisan standoff. That was unfortunate.
  I am hopeful that the Committees will work this year to examine these 
issues completely and substantively. Health care costs are rising 
everyday, Mr. President. We must balance the need to protect patients 
with the need to make health care accessible. The Committees will need 
to examine the current trends in the market place and evaluate any 
legislation on all fronts, not just political rhetoric. Health care is 
just too important to politicize.
  Mr. President, I ask unanimous consent that the text of the bill and 
a summary be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                 S. 300

       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 Plus Act''.
       (b) Table Of Contents.--The table of contents for this Act 
     is as follows:
Sec. 1. Short title; table of contents.

                   TITLE I--PATIENTS' 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 provision.
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.

                  Subtitle D--Miscellaneous Provisions

Sec. 131. Amendments to the Internal Revenue Code of 1986.

     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.
Sec. 233. Effective date.

              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 RESEARCH AND QUALITY

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

         ``TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

               ``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 and access in underserved 
              areas.
``Sec. 916. Clinical practice and technology innovation.
``Sec. 917. Coordination of Federal Government quality improvement 
              efforts.

                      ``Part C--General Provisions

``Sec. 921. Advisory Council for Healthcare Research and Quality.
``Sec. 922. Peer review with respect to grants and contracts.
``Sec. 923. Certain provisions with respect to development, collection, 
              and dissemination of data.
``Sec. 924. Dissemination of information.
``Sec. 925. Additional provisions with respect to grants and contracts.
``Sec. 926. Certain administrative authorities.
``Sec. 927. Funding.
``Sec. 928. Definitions.
Sec. 403. References.
Sec. 404. Study.

         TITLE V--ENHANCED ACCESS TO HEALTH INSURANCE COVERAGE

Sec. 501. Full deduction of health insurance costs for self-employed 
              individuals.
Sec. 502. Full availability of medical savings accounts.
Sec. 503. Carryover of unused benefits from cafeteria plans, flexible 
              spending arrangements, and health flexible spending 
              accounts.
Sec. 504. Permitting contribution towards medical savings account 
              through Federal employees health benefits program 
              (FEHBP).
                   TITLE I--PATIENTS' 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 
     (other than a fully insured 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, including ancillary services routinely 
     available to 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

[[Page S905]]

     care to stabilize an emergency medical condition following an 
     emergency medical screening examination (if determined 
     necessary under paragraph (1)), pursuant to the definition of 
     stabilize under section 1867(e)(3) of the Social Security Act 
     (42 U.S.C. 1395dd(e)(3)).
       ``(b) Uniform Cost-Sharing Required.--Nothing in this 
     section shall be construed as preventing a group health plan 
     (other than a fully insured 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 (other than a fully insured group health 
     plan), covered inpatient and outpatient services that--
       ``(A) are furnished by any provider, including a 
     nonparticipating provider, that is qualified to furnish such 
     services; and
       ``(B) are needed to evaluate or stabilize (as such term is 
     defined in section 1867(e)(3) of the Social Security Act (42 
     U.S.C. 1395dd)) an emergency medical condition (as defined in 
     paragraph (2)).
       ``(2) Emergency medical condition.--The term ``emergency 
     medical condition'' means a medical condition manifesting 
     itself by acute symptoms of sufficient severity (including 
     severe pain) such that a prudent layperson, who possesses an 
     average knowledge of health and medicine, could reasonably 
     expect the absence of immediate medical attention to result 
     in--
       ``(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 (other 
     than a fully insured 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 (other than a fully 
     insured 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 (other than a 
     fully insured group health plan), coverage of such benefits 
     when provided by a nonparticipating health care professional.
       ``(c) Small Employer Exemption.--
       ``(1) In general.--This section shall not apply to any 
     group health plan (other than a fully insured group health 
     plan) of a small employer.
       ``(2) Small employer.--For purposes of paragraph (1), the 
     term `small employer' means, in connection with a group 
     health plan (other than a fully insured group health plan) 
     with respect to a calendar year and a plan year, an employer 
     who employed an average of at least 2 but not more than 50 
     employees on business days during the preceding calendar year 
     and who employs at least 2 employees on the first day of the 
     plan year. For purposes of this paragraph, the provisions of 
     subparagraph (C) of section 712(c)(1) shall apply in 
     determining employer size.
       ``(d) Rule of Construction.--Nothing in this section shall 
     be construed--
       ``(1) as requiring coverage for benefits for a particular 
     type of health care professional;
       ``(2) as requiring an employer to pay any costs as a result 
     of this section or to make equal contributions with respect 
     to different health coverage options;
       ``(3) as preventing a group health plan (other than a fully 
     insured group health plan) from imposing higher premiums or 
     cost-sharing on a participant for the exercise of a point-of-
     service coverage option; or
       ``(4) to require that a group health plan (other than a 
     fully insured group health plan) include coverage of health 
     care professionals that the plan excludes because of fraud, 
     quality of care, or other similar reasons with respect to 
     such professionals.

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

       ``(a) In General.--In any case in which a group health plan 
     (other than a fully insured 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 (other than a 
     fully insured 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 related to 
     the care described in subparagraph (A) or (B) of subsection 
     (a)(1), by the participating physician providing the care 
     described in either such subparagraph, 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. Nothing in 
     subsection (b) shall be construed to preclude the health plan 
     from requiring that the obstetrician or gynecologist notify 
     the primary care provider or the plan of treatment decisions.

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

       ``(a) In General.--In any case in which a group health plan 
     (other than a fully insured 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 (other than a 
     fully insured 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 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 (other than a fully insured 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 such 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;
       ``(B) provide the individual with an opportunity to notify 
     the plan of a need for transitional care; and
       ``(C) in the case of termination described in paragraph 
     (2), (3), or (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) Terminated.--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.
       ``(3) Contracts.--For purposes of this section, the term 
     `contract between a group health plan (other than a fully 
     insured group health plan) and a health care provider' shall 
     include a contract between such a plan and an organized 
     network of providers.
       ``(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.

[[Page S906]]

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

     ``SEC. 727. GENERALLY APPLICABLE PROVISION.

       ``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) Definition.--Section 733(a) of the Employee Retirement 
     Income Security Act of 1974 (42 U.S.C. 1186(a)) is amended by 
     adding at the end the following:
       ``(3) Fully insured group health plan.--The term `fully 
     insured group health plan' means a group health plan where 
     benefits are provided pursuant to the terms of an arrangement 
     between a group health plan and a health insurance issuer and 
     are guaranteed by the health insurance issuer under a 
     contract or policy of insurance.''.
       (d) Conforming Amendment.--The table of contents in section 
     1 of 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, as 
     amended by the Omnibus Consolidated and Emergency 
     Supplemental Appropriations Act, 1999 (Public Law 105-277), 
     is amended by adding at the end the following:

     ``SEC. 714. 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.
       ``(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

[[Page S907]]

     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 regarding--
       ``(A) the manner in which an enrollee may access an 
     obstetrician, gynecologist, or pediatrician in accordance 
     with section 723 or 724;
       ``(B) the manner in which an enrollee obtains continuity of 
     care as provided for in section 725; and
       ``(C) the manner in which an enrollee has access to the 
     medical records of the enrollee in accordance with subtitle A 
     of title II of the Patients' Bill of Rights Plus Act.
       ``(14) 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 
     714''.
       (2) The table of contents in section 1 of the Employee 
     Retirement Income Security Act of 1974 (29 U.S.C. 1001) is 
     amended by inserting after the item relating to section 713, 
     the following:
``Sec. 714. Health plan comparative information.''.

     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 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.

[[Page S908]]

       ``(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.--A review of 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--
       ``(A) the particular item or service involved, when 
     medically appropriate and necessary, is 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 a significant financial threshold; 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), 
     or earlier in accordance with the medical exigencies of the 
     case, the plan or issuer involved shall select an external 
     appeals entity under paragraph (3)(A) that shall be 
     responsible for designating an 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 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.

[[Page S909]]

       ``(B) Designation of external reviewer by external appeals 
     entity.--The external appeals entity designated under 
     subparagraph (A) shall, not later than 30 days after the date 
     on which such entity is designated under subparagraph (A), or 
     earlier in accordance with the medical exigencies of the 
     case, designate one or more individuals to serve as 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 of any drug, device, procedure, or other therapy 
     proposed for the enrollee whose treatment is under review;
       ``(iii) be experts in the diagnosis or treatment under 
     review and, when reasonably available, be of the same 
     speciality of the physician prescribing the treatment in 
     question;
       ``(iv) receive only reasonable and customary compensation 
     from the group health plan or health insurance issuer in 
     connection with the 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; and
       ``(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.--
       ``(A) In general.--An external reviewer shall complete a 
     review of an adverse coverage determination in accordance 
     with the medical exigencies of the case.
       ``(B) Limitation.--Notwithstanding subparagraph (A), a 
     review described in such subparagraph shall be completed not 
     later than 30 working days after the later of--
       ``(i) the date on which such reviewer is designated; or
       ``(ii) the date on which all information necessary to 
     completing such review is received.
       ``(6) Binding determination.--The determination of an 
     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) Effect on certain provisions.--Nothing in this 
     section shall be construed as affecting or modifying section 
     514 of this Act with respect to a group health plan.
       ``(f) Rule of Construction.--Nothing in this section shall 
     be construed to prohibit a plan administrator or plan 
     fiduciary or health plan medical director from requesting an 
     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) Group health plan.--The term `group health plan' 
     shall have the meaning given such term in section 733(a). In 
     applying this paragraph, excepted benefits described in 
     section 733(c) shall not be treated as benefits consisting of 
     medical care.
       ``(6) Health insurance coverage.--The term `health 
     insurance coverage' has the meaning given such term in 
     section 733(b)(1). In applying this paragraph, excepted 
     benefits described in section 733(c) shall not be treated as 
     benefits consisting of medical care.
       ``(7) Health insurer.--The term `health insurer' means an 
     insurance company, insurance service, or an insurance 
     organization that meets the requirements of section 733(b)(2) 
     and that offers health insurance coverage in connection with 
     a group health plan.
       ``(8) 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.
       ``(9) 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.
       ``(10) 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 striking the item relating to section 503 and 
     inserting the following new item:
``Sec. 503. Claims procedures, coverage determination, grievances and 
              appeals.''.
       (d) Effective Date.--The amendments made by this section 
     shall apply with respect to plan years beginning on or after 
     1 year after the date of enactment of this Act. The Secretary 
     shall issue all regulations necessary to carry out the 
     amendments made by this section before the effective date 
     thereof.
                  Subtitle D--Miscellaneous Provisions

     SEC. 131. AMENDMENTS TO THE INTERNAL REVENUE CODE OF 1986.

       Subchapter B of chapter 100 of the Internal Revenue Code of 
     1986 (as amended by section 1531(a) of the Taxpayer Relief 
     Act of 1997) is amended--
       (1) in the table of sections, by inserting after the item 
     relating to section 9812 the following new item:
``Sec. 9813. Standard relating to Patients' bill of rights.''; and
       (2) by inserting after section 9812 the following:

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

       ``A group health plan shall comply with the requirements of 
     section 714 and subpart C of part 7 of subtitle B of title I 
     of the Employee Retirement Income Security Act of 1974 (as in 
     effect as of the date of the enactment of the Patients' Bill 
     of Rights Plus Act), and such requirements shall be deemed to 
     be incorporated into this section.''.
     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--

[[Page S910]]

       (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.
       (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 a 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

[[Page S911]]

     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, 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.

     SEC. 233. EFFECTIVE DATE.

       The provisions of this title shall become effective 
     beginning on the date that is 1 year after the date of 
     enactment of this Act. The Secretary shall issue regulations 
     necessary to carry out this title before the effective date 
     thereof.
              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 1999''.

     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 Plus 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, as amended by the Omnibus 
     Consolidated and Emergency Supplemental Appropriations Act, 
     1999 (Public Law 105-277), is amended by adding at the end 
     the following new section:

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

       ``A group health plan, or a health insurance issuer 
     offering group health insurance coverage in connection with a 
     group health plan shall not adjust premium or contribution 
     amounts for a group on the basis of predictive genetic 
     information concerning 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

[[Page S912]]

     of predictive genetic information (including information 
     about a request for or receipt of genetic services), see 
     section 2707.''.
       (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, 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 Plus 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), as amended by the Omnibus Consolidated and 
     Emergency Supplemental Appropriations Act, 1999 (Public Law 
     105-277) is amended--
       (1) by redesignating such subpart as subpart 2; and
       (2) by adding at the end the following:

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

       ``(a) Prohibition on Predictive Genetic Information as a 
     Condition of Eligibility.--A health insurance issuer offering 
     health insurance coverage in the individual market may not 
     use predictive genetic information as a condition of 
     eligibility of an individual to enroll in individual health 
     insurance coverage (including information about a request for 
     or receipt of genetic services).
       ``(b) Prohibition on Predictive Genetic Information in 
     Setting Premium Rates.--A health insurance issuer offering 
     health insurance coverage in the individual market shall not 
     adjust premium rates for individuals on the basis of 
     predictive genetic information concerning such an 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 Plus 
     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 (as amended by section 131) is 
     further amended by adding at the end the following:

     ``SEC. 9814. PROHIBITING HEALTH DISCRIMINATION AGAINST GROUPS 
                   ON THE BASIS OF PREDICTIVE GENETIC INFORMATION.

       ``A group health plan shall not adjust premium or 
     contribution amounts for a group on the basis of predictive 
     genetic information concerning 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 
     9814.''.
       (3) Amendment to table of sections.--The table of sections 
     for subchapter B of chapter 100 of the Internal Revenue Code 
     of 1986 (as amended by section 131) is further amended by 
     adding at the end the following:

``Sec. 9814. 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 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 that provides health care items and services to 
     an individual or dependent may request (but may not require) 
     that such individual or dependent disclose, or authorize the 
     collection or disclosure of, predictive genetic information 
     for purposes of diagnosis, treatment, or payment relating to 
     the provision of health care items and services to such 
     individual or dependent.
       ``(B) Notice of confidentiality practices; description of 
     safeguards.--As a part of a request under subparagraph (A), 
     the group health plan shall provide to the individual or 
     dependent a description of the procedures in place to 
     safeguard the confidentiality, as described in sections 213 
     and 221 of the Patients' Bill of Rights Plus 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--

[[Page S913]]

       ``(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
       ``(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 RESEARCH AND QUALITY

     SEC. 401. SHORT TITLE.

       This title may be cited as the ``Healthcare Research and 
     Quality Act of 1999''.

     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 RESEARCH AND QUALITY

               ``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 Research and Quality. In carrying out this 
     subsection, the Secretary shall redesignate the Agency for 
     Health Care Policy and Research as the Agency for Healthcare 
     Research and Quality.
       ``(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 and health 
     system 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 
     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, acute and long-term 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, purchasers, and 
     practitioners acquire new information about best practices 
     and health benefits, the determinants and impact 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 
     disabilities, 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 Research and Quality. 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, organization, 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.--
       ``(1) In general.--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 487.
       ``(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.
       ``(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, XIX 
     and XXI of the Social Security Act shall be carried out 
     consistent with section 1142 of such Act.
       ``(e) Disclaimer.--The Agency shall not 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 the Agency's role is to mandate a 
     national standard or specific approach to quality measurement 
     and reporting. 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, recommendations in the research literature, and 
     technology assessments. 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--

[[Page S914]]

       ``(A) Healthcare Improvement Research Centers that combine 
     demonstrated multidisciplinary expertise in outcomes or 
     quality improvement research with linkages to relevant sites 
     of care;
       ``(B) Provider-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 to link 
     research with clinical practice.
       ``(2) Requirements.--The Director is authorized to 
     establish the requirements for entities applying for grants 
     under this subsection.

     ``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 research and quality, the 
     Agency may provide scientific and technical support for 
     private and public efforts to improve healthcare quality, 
     including the activities of 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--
       ``(i) methods for the evaluation of the health of enrollees 
     in health plans by type of plan, provider, and provider 
     arrangements; and
       ``(ii) other populations, including those receiving long-
     term care services;
       ``(B) the ongoing development, testing, and dissemination 
     of quality measures, including measures of health and 
     functional outcomes;
       ``(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) identifying and disseminating information on 
     mechanisms for the integration of information on quality into 
     purchaser and consumer decision-making processes.
       ``(b) 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 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) Pharmacists, 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) an increase in 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.
       ``(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;
       ``(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 on a nationally representative sample of 
     the population on the cost, use and, for fiscal year 2000 and 
     subsequent fiscal years, quality 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;
       ``(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.
     In expanding the Medical Expenditure Panel Survey, as in 
     existence on the date of enactment of this title) in fiscal 
     year 2000 to collect information on the quality of care, the 
     Director shall take into account any outcomes measurements 
     generally collected by private sector accreditation 
     organizations.
       ``(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, evaluations 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 
     data;
       ``(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, including the use of real-time 
     healthcare decision-support programs;
       ``(5) the structure, content, definition, and coding of 
     health information data and medical vocabularies in 
     consultation with appropriate Federal and private entities;
       ``(6) the 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 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 Research.--
       ``(1) In general.--There is established within the Agency a 
     Center for Primary Care Research (referred to in this 
     subsection as the `Center') that shall serve as the principal 
     source of funding for primary care research in the Department 
     of Health and Human Services. For purposes of this paragraph, 
     primary care 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 
     practice;
       ``(B) the management of commonly occurring clinical 
     problems;
       ``(C) the management of undifferentiated clinical problems; 
     and
       ``(D) the continuity and coordination of health services.
       ``(3) Demonstration.--The Agency shall support 
     demonstrations into the use of new

[[Page S915]]

     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;
       ``(2) developing, evaluating, and disseminating 
     methodologies for assessments of healthcare practices and 
     healthcare technologies;
       ``(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 December 31, 2000, 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 Assistance 
     Secretary for Health, 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 or support 
     specific assessments of healthcare technologies and 
     practices.
       ``(2) Requests for assessments.--The Director is authorized 
     to conduct or support assessments, on a reimbursable basis, 
     for the Health Care Financing Administration, the Department 
     of Defense, the Department of Veterans Affairs, the Office of 
     Personnel Management, and other public or private entities.
       ``(3) Grants and contracts.--In addition to conducting 
     assessments, the Director may make grants to, or enter into 
     cooperative agreements or contracts with, entities described 
     in paragraph (4) for the purpose of conducting assessments of 
     experimental, emerging, existing, or potentially outmoded 
     healthcare technologies, and for related activities.
       ``(4) 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.--To avoid duplication and ensure that 
     Federal resources are used efficiently and effectively, 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 an independent, external review of its 
     quality oversight, and quality 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 including those 
     currently performed by the peer review organizations and the 
     exploration of additional activities that could be undertaken 
     by the peer review organizations to improve quality;
       ``(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 between the Federal Government and the 
     private sector or within the Federal Government could be 
     pursued to improve quality oversight of the medicare, 
     medicaid and child health insurance programs under titles 
     XVIII, XIX and XXI of the Social Security Act; and
       ``(iv) an identification of opportunities for enhancing 
     health system efficiency through simplification and reduction 
     in redundancy of Federal agency quality improvement efforts, 
     including areas in which Federal efforts unnecessarily 
     duplicate existing private sector efforts; and
       ``(B) to identify options and make recommendations to 
     improve the efficiency and effectiveness of such quality 
     improvement programs through--
       ``(i) the improved coordination of activities across the 
     medicare, medicaid and child health insurance programs under 
     titles XVIII, XIX and XXI of the Social Security Act and 
     various health services research programs;
       ``(ii) the strengthening of patient choice and 
     participation by incorporating state-of-the-art quality 
     monitoring tools and making information on quality available; 
     and
       ``(iii) 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.
       ``(B) Reports.--The Secretary shall submit the reports 
     described in subparagraph (A) to the Committee on Finance and 
     the Committee on Health, Education, Labor, and Pensions of 
     the Senate and the Committee on Ways and Means and the 
     Committee on Commerce of the House of Representatives.

                      ``PART C--GENERAL PROVISIONS

     ``SEC. 921. ADVISORY COUNCIL FOR HEALTHCARE RESEARCH AND 
                   QUALITY.

       ``(a) Establishment.--There is established an advisory 
     council to be known as the Advisory Council for Healthcare 
     Research and Quality.
       ``(b) Duties.--
       ``(1) In general.--The Advisory Council shall advise the 
     Secretary and the Director with respect to activities 
     proposed or undertaken 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 pertaining to healthcare 
     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) as ex officio members.
       ``(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 other 
     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;

[[Page S916]]

       ``(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 Assistant Secretary for Health, 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.

     ``SEC. 922. 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 these 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 may 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, pursuant to their work for the group, 
     as confidential information, except that this subparagraph 
     shall not apply to public records and public 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 a directly affected 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 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 or provider-based research, and 
     for such other purposes as the Director may determine to 
     be appropriate.
       ``(e) Regulations.--The Director may shall issue 
     regulations for the conduct of peer review under this 
     section.

     ``SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, 
                   COLLECTION, AND DISSEMINATION OF DATA.

       ``(a) Standards With Respect to Utility of Data.--
       ``(1) In general.--To ensure the utility, accuracy, and 
     sufficiency of data collected by or for the Agency for the 
     purpose described in section 901(b), the Director shall 
     establish standards and methods for developing and collecting 
     such data, taking into consideration--
       ``(A) other Federal health data collection standards; and
       ``(B) the differences between types of healthcare plans, 
     delivery systems, healthcare providers, and provider 
     arrangements.
       ``(2) Relationship with other department programs.--In any 
     case where standards under paragraph (1) may affect the 
     administration of other programs carried out by the 
     Department of Health and Human Services, including the 
     programs under titles XVIII, XIX and XXI of the Social 
     Security Act, they shall be in the form of recommendations to 
     the Secretary for such program.
       ``(b) Statistics and Analyses.--The Director shall--
       ``(1) take appropriate action to ensure that statistics and 
     analyses developed under this title are of high quality, 
     timely, and duly comprehensive, and that the statistics are 
     specific, standardized, and adequately analyzed and indexed; 
     and
       ``(2) publish, make available, and disseminate such 
     statistics and analyses on as wide a basis as is practicable.
       ``(c) Authority Regarding Certain Requests.--Upon request 
     of a public or private entity, the Director may conduct or 
     support 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. 924. DISSEMINATION OF INFORMATION.

       ``(a) In General.--The Director 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) ensure that information disseminated by the Agency is 
     science-based and objective and undertakes consultation as 
     necessary to assess the appropriateness and usefulness of the 
     presentation of information that is targeted to specific 
     audiences;
       ``(3) promptly make available to the public data developed 
     in such research, demonstration projects, and evaluations;
       ``(4) provide, in collaboration with the National Library 
     of Medicine where appropriate, 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
       ``(5) 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 Secretary) 
     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 
     under regulations of the Secretary) 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

[[Page S917]]

     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.

     ``SEC. 925. ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND 
                   CONTRACTS.

       ``(a) 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.
       ``(b) 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.
       ``(c) 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.
       ``(d) Applicability of Certain Provisions With Respect to 
     Contracts.--Contracts may be entered into under this part 
     without regard to sections 3648 and 3709 of the Revised 
     Statutes (31 U.S.C. 529; 41 U.S.C. 5).

     ``SEC. 926. 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 statutory obligation owed to 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. 927. 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 $185,000,000 for fiscal year 2000, and such sums 
     as may be necessary for each of the fiscal years 2001 through 
     2006.
       ``(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.

     ``SEC. 929. DEFINITIONS.

       ``In this title:
       ``(1) Advisory council.--The term `Advisory Council' means 
     the Advisory Council on Healthcare Research and Quality 
     established under section 921.
       ``(2) Agency.--The term `Agency' means the Agency for 
     Healthcare Research and Quality.
       ``(3) Director.--The term `Director' means the Director for 
     the Agency for Healthcare Research and Quality.''.

     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 Research and Quality''.

     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 Research and Quality, 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, 1999.
       (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--ENHANCED ACCESS TO HEALTH INSURANCE COVERAGE

     SEC. 501. 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:

[[Page S918]]

       ``(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, 
     1999.

     SEC. 502. 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 
     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, 
     1999.

     SEC. 503. CARRYOVER OF UNUSED BENEFITS FROM CAFETERIA PLANS, 
                   FLEXIBLE SPENDING ARRANGEMENTS, AND HEALTH 
                   FLEXIBLE SPENDING ACCOUNTS.

       (a) In General.--Section 125 of the Internal Revenue Code 
     of 1986 (relating to cafeteria plans) is amended by 
     redesignating subsections (h) and (i) as subsections (i) and 
     (j) and by inserting after subsection (g) the following new 
     subsection:
       ``(h) Allowance of Carryovers of Unused Benefits to Later 
     Taxable Years.--
       ``(1) In general.--For purposes of this title--
       ``(A) notwithstanding subsection (d)(2), a plan or other 
     arrangement shall not fail to be treated as a cafeteria plan 
     or flexible spending or similar arrangement, and
       ``(B) no amount shall be required to be included in gross 
     income by reason of this section or any other provision of 
     this chapter,

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

     Any amount rolled over under this subparagraph shall be 
     treated as a rollover contribution for the taxable year from 
     which the unused amount would otherwise be carried.
       ``(C) Treatment of rollover.--Any amount rolled over under 
     subparagraph (B) shall be treated as an eligible rollover 
     under section 220, 401(k), 403(b), or 457, whichever is 
     applicable, and shall be taken into account in applying any 
     limitation (or participation requirement) on employer or 
     employee contributions under such section or any other 
     provision of this chapter for the taxable year of the 
     rollover.
       ``(4) Cost-of-living adjustment.--In the case of any 
     taxable year beginning in a calendar year after 1999, 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, 1998, and any increase 
     which is not a multiple of $50 shall be rounded to the next 
     lowest multiple of $50.''
       ``(5) Applicability.--This subsection shall apply to 
     taxable years beginning after December 31, 1999.''
       (b) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     1999.

     SEC. 504. 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) Determining level of government contributions.--Section 
     8906(b) of such title is amended by adding at the end the 
     following: ``Subscription charges for medical savings 
     accounts shall be deemed to be the amount of Government 
     contributions made under subsection (j)(2).''.

[[Page S919]]

       (c) Effective Date.--The amendments made by this section 
     shall apply to contract terms beginning on or after January 
     1, 2000.
                                  ____


         Summary of Senate Republican Patients' Bill of Rights

       The Senate Republican bill has six major components that 
     will provide consumer protections, enhance health care 
     quality and increase access. These are:
       1. Consumer protection standards for self-funded plans.
       2. Appeals standards for all group health plans.
       3. Access to and confidentiality of medical information.
       4. Ban on the use of genetic information for all plans.
       5. New quality focus and expended research activities for 
     the Agency for Health Care Policy and Research.
       6. Improved access to health insurance coverage by allowing 
     full deduction of health insurance for the self-employed and 
     expansion of MSAs.
       The following summarizes the key aspects of the bill:
       1. Consumer protection standards for self-funded plans: 
     Since States are responsible for regulating insured health 
     plans, the bill provides that the following standards would 
     apply only to self-funded plans governed by ERISA.
       Emergency Care: Plans would be required to use the 
     ``prudent layperson'' standard for providing initial 
     emergency screening exams and ``additional emergency 
     services'' determined necessary by a ``prudent emergency 
     medical professional.''
       Mandatory Point of Service: Plans that offer network-only 
     plans would be required to offer enrollees the option to 
     purchase point-of-service coverage. Small employers with 50 
     or fewer workers would be exempt. Also exempt would be group 
     plans that offer a choice of two or more health insurance 
     options or two or more options with significantly different 
     providers. Plans could charge higher premiums and cost 
     sharing for the POS option.
       OB-GYN/Pediatricians: Health plans would be required to 
     allow direct access to obstetricians/gynecologist and 
     pediatricians without referrals.
       Continuity of Care: Plans who terminate or non renew 
     providers from their networks would be required to notify 
     enrollees and allow continued use of the provider (at the 
     same payment and cost-sharing rates) for up to 90 days if: 
     the enrollee is receiving institutional care, is in the 
     second (or late) trimester of pregnancy, or is terminally 
     ill.
       Gag Rules: Plans would be prohibited from including ``gag 
     rules'' in providers' contracts.
       Comparative Information: Plans would be required to provide 
     a wide range of information about health insurance options, 
     such as descriptions of the networks, premium and cost-
     sharing information. Quality outcomes data and information is 
     not mandated.
       Effective Dates: The new rules would become effective for 
     group plan years beginning on or after January 1 of the 
     second calendar year following the date of enactment. In 
     other words, the effective date would be January, 2001, 
     assuming enactment in 1999.
       2. Grievance and Appeals: Plans would be required to have 
     written grievance procedures and have both an internal and 
     external appeals procedure. Grievances would not be 
     appealable.
       Prior Authorization: Routine requests would need to be 
     completed within 30 days, and expedited requests for care 
     that could jeopardize enrollee's health would have to be 
     handled within 72 hours.
       Qualification of Doctors for Internal Appeals: Appeals for 
     coverage determinations based on lack of medical necessity or 
     experimental treatment must be by a doctor ``with appropriate 
     expertise in field of medicine involved'' who was not 
     involved in the initial decision.
       External Appeals: Enrollees and providers could appeal to 
     independent medical reviewers for amounts above a significant 
     financial threshold for issues based on medical necessity or 
     for services that involve an experimental treatment where the 
     enrollees' life is in jeopardy. External reviews could 
     include those licensed by the State or under Federal contract 
     for this purpose, a teaching hospital, or entities meeting 
     specific criteria. External review is binding on plans and 
     issuers.
       3. Patient medical records: Plans, providers, schools, and 
     others would be required to:
       Permit enrollees to inspect and copy their own medical 
     records, except when such information could endanger a 
     person's physical safety.
       Disclose their confidentiality practices and to establish 
     appropriate safeguards for patient information.
       Civil money penalties would be imposed for violations.
       4. Genetic Information: All plans--self-funded and insured 
     group plans, as well as individual plans--would be prohibited 
     from denying coverage, or adjusting premiums or contribution 
     amounts based on ``predictive genetic information.'' The term 
     ``predictive genetic information'' includes individual's 
     genetic tests, genetic tests of family members, or 
     information about family medical history.
       5. Refocusing AHCPR on Quality Improvement: The bill would 
     refocus AHCPR (and rename it the Agency for Healthcare 
     Quality Research) to encourage overall improvement of quality 
     in the nation's health care systems. The new agency would 
     facilitate support of state-of-the-art information systems, 
     support of primary care research, technology assessment and 
     coordination of the Federal Government's own quality 
     improvement efforts.
       6. Improved Access to Health Insurance: The bill includes 
     three provisions to improve access:
       Allows full deduction of health insurance for self-employed 
     individuals.
       Gives individuals the ability to carry forward up to $500 
     in their flexible spending accounts from one year to the next 
     or to be deposited into an IRA, and MSA, or a 401(k) plan.
       Lifts the caps for MSAs and would allow all individuals, 
     including Federal employees, the option to purchase these 
     plans.

 Ms. COLLINS. Mr. President, I am pleased to be joining my 
colleagues in introducing this Patients' Bill of Rights, which is the 
product of more than a year's worth of intensive work and negotiations 
by the Senate Republican Health Care Task Force on which I serve.
  This comprehensive legislation has three major purposes. First, it 
will protect patients' rights and hold HMOs accountable for providing 
the care they have promised. Second, it will expand consumer choice and 
access to affordable care. And third, it will improve health care 
quality and outcomes.
  Mr. President, there is a growing unease across our country about 
changes in how we receive our health care. People worry that if they or 
their loved ones become seriously ill, their HMO will deny them 
coverage and force them to accept either inadequate care or financial 
ruin--or perhaps both.
  They feel that vital decisions affecting their lives will be made, 
not by a supportive family doctor, but by an unfeeling bureaucracy. The 
American people, known for taking charge of their destiny, feel 
increasingly powerless about their health care. Our bill will ensure 
that medical decisions remain in the hands of patients and physicians, 
not HMO accountants and trial lawyers.
  All of us agree that medically-necessary patient care should not be 
sacrificed to the bottom line. However, according to a 1997 study by 
Lewin, every one percent increase in health care premiums results in as 
many as 400,000 uninsured Americans. I have therefore been alarmed by 
reports that American businesses everywhere--from large multinational 
corporations to the corner store--are facing huge hikes in health 
insurance premiums in 1999, ranging from about 8 percent on average, to 
20 percent or more. This is a remarkable contrast to the last few 
years, when premiums rose less than 2 or 3 percent, if at all.
  We are engaged in an extremely delicate balancing act as we attempt 
to respond to concerns about quality, without resorting to unduly 
burdensome federal controls and mandates that will further drive up 
costs, causing thousands of Americans to lose their coverage and 
pushing health insurance further out of reach for many uninsured 
Americans.
  Our Patients' Bill of Rights does not pre-empt, but rather builds 
upon the good work that states have done in the area of patients' 
rights and protections. Congress agreed that states should have primary 
responsibility for the regulation of health insurance when it passed 
the McCarran-Ferguson Act in 1945. And, as someone who has overseen a 
Bureau of Insurance in state government, I think state regulators have 
done a good job of responding to the needs and concerns of their 
citizens. For instance, at my last count, 44 states had passed laws 
prohibiting ``gag clauses'' that restrict communications between 
patients and their doctors, and the remaining six had bills pending in 
their legislatures. States acted without any mandate or prod from 
Washington to protect consumers.
  Moreover, one size does not fit all, and what may be appropriate for 
one state may not be necessary in another. Florida, for instance, 
provides for direct access to a dermatologist, which is understandable, 
given the high rate of skin cancer in that state. But in a state like 
Maine this may not be so important.
  So why does Congress need to act? The answer is that federal law 
prohibits states from regulating the self-funded, employer-sponsored 
health plans that cover 48 million Americans.
  Our bill extends many of the same rights and protections to these 
individuals and their families that Americans

[[Page S920]]

in state-regulated plans already enjoy. For the first time, they will 
be guaranteed the right to talk freely and openly with their doctors 
about their treatment options without being subject to ``gag clauses'' 
that limit communications. They will be guaranteed coverage for 
emergency room care that a ``prudent layperson'' would consider 
medically necessary without prior authorization from their health plan. 
They will be able to see their OB-GYN or pediatrician without a 
referral from their plan's ``gatekeeper,'' and they will have the 
option of seeing a doctor who is not a part of their HMO's network. 
They will also have some assurance of continuity of care if their 
health plan terminates its contract with their doctor or hospital.
  Moreover, all patients will be given the right to review their 
medical records and will have added protections to ensure that this 
information will be kept confidential. Finally, insurers will be 
prohibited from collecting or using predictive genetic information 
about a patient to deny coverage or set premium rates.
  Mr. President, the states are way ahead of the federal government in 
the area of insurance reform, and the State of Maine has already 
enacted many of these same consumer rights and protections--a ban on 
gag clauses, a prudent layperson definition for emergency care, and 
direct access to OB/GYNs. Our bill would extend these and other rights 
to the nearly 220,000 Maine citizens in health plans that are not 
subject to state regulation and who currently do not enjoy these 
protections.
  A key provision of our bill would give all 125 million Americans in 
employer-sponsored plans assurance that they will get the care that 
they need, when they need it. This includes 535,735 people in Maine who 
are in fully-insured ERISA plans. For the first time, these individuals 
will be entitled to clear and complete information about their health 
plan--about what it does and does not cover, about any cost-sharing 
requirements, and about the plan's providers. Helping patients 
understand their coverage before they need to use it will help to avoid 
coverage disputes later.
  The goal of any patient protection legislation should be to solve 
disputes about coverage up from, when the care is needed. Not months, 
or even years later, in a court room.
  Our bill would accomplish this goal by creating both an internal and 
external review process. First, patients or doctors who are unhappy 
with an HMO's decision could appeal it internally through a review 
conducted by individuals with ``appropriate expertise'' who were not 
involved in the initial decision. Moreover, this review would have to 
be conducted by a physician if the coverage denial is based on a 
determination that the service is not medically necessary or is an 
experimental treatment. Patients could expect results from this review 
within 30 days, or 72 hours in cases when delay poses a serious risk to 
the patient's life or health.
  Patients turned down by this internal review would then have the 
right to a free, external review by medical experts who are completely 
independent of their health plan. This review must be completed within 
thirty days--and even faster in a medical emergency or when delay would 
be detrimental to the patient's health. Moreover, the decision of these 
outside reviewers is binding on the health plan, but not on the 
patient. If the patient is not satisfied, they retain the right to sue 
in federal or state court for attorneys' fees, court costs, the value 
of the benefit and injunctive relief.
  Our bill differs from the Democrats' bill in a fundamental respect: 
it places treatment decisions in the hands of doctors, not lawyers. If 
your HMO denies you treatment that your doctor believes is medically 
necessary, you should not have to resort to a costly and lengthy court 
battle to get the care you need. After all, doesn't it make more sense 
to put medical care in the hands of doctors, not lawyers? You should 
not have a resort to hiring a lawyer and filing an expensive lawsuit to 
get the treatment. You just can't sue your way to quality health care.
  The purpose of our bill is to solve problems up-front when the care 
is needed, not months or even years later after the harm has occurred. 
According to the GAO, it takes an average of 33 months to resolve 
malpractice cases. One case in the study took 11 years. This does 
absolutely nothing to ensure a patient's right to timely and 
appropriate care. Moreover, patients only receive 43 cents out of every 
dollar awarded in malpractice cases. The rest winds up in the pockets 
of the trial lawyers and administrators of the court and insurance 
systems.
  Finally, more lawsuits are certain to mean higher health care costs. 
According to the Barents Group of KPMG Peat Marwick, increased lawsuits 
could drive up premiums as much as 8.6 percent, forcing businesses to 
pay $94.1 billion ($1,284 per worker) in extra premiums over five 
years. Close to two million Americans could lose their health insurance 
next year as increased costs force many employers to eliminate coverage 
altogether, or to pass on higher premiums and out-of-pocket costs to 
employees who can't afford them.
  Last fall I met with a group of Maine employers who expressed their 
serious concerns about the Democrats' proposal to expand liability for 
health plans and employers. The Assistant Director for Human Resources 
at Bowdoin College talked about how moving to a self-funded, ERISA plan 
enabled them to continue to offer affordable coverage to Bowdoin 
employees when premiums for their fully-insured plan skyrocketed in the 
late 1980s. Since they self-funded, they have actually been able to 
lower premiums for their employees, while at the same time, enhance 
their benefit designs with such features as well-baby care, free annual 
physicals, and prescription drug cards with low copayments. They told 
me that the Democrats' proposal to expand liability seriously 
jeopardizes their ability to offer affordable coverage for their 
employees. Similar concerns were expressed by the Maine Municipal 
Association, L.L. Bean, Bath Iron Works, and others.
  Mr. President, our bill also contains important provisions to improve 
health care quality and outcomes for all Americans.
  For example, I am particularly pleased that our bill contains the 
proposal introduced by my colleague from Maine, Senator Snowe, that 
prohibits insurers from discriminating on the basis of predictive 
genetic information.
  Genetic testing holds tremendous promise for individuals who have a 
genetic predisposition to beat cancer and other diseases and conditions 
with a genetic link. However, this promise is significantly threatened 
when insurance companies use the results of such testing to deny or 
limit coverage to consumers on the basis of genetic information. In 
addition to the potentially devastating consequences of being denied 
health insurance on the basis of genetic information, the fear of 
discrimination may discourage individuals who might benefit from having 
this information from ever getting tested.
  And finally, our bill will make health insurance more affordable by 
allowing self-employed individuals to deduct the full amount of their 
health care premiums beginning not in 2003, as in current law, but next 
year.
  Establishing parity in the tax treatment of health insurance costs 
between the self-employed and those working for large businesses is a 
matter of basic equity, and it will also help to reduce the number of 
uninsured, but working, Americans. It will make health insurance more 
affordable for the 82,000 people in Maine who are self-employed. They 
include our lobstermen, our hairdressers, our electricians, our 
plumbers, and the many owners of mom-and-pop stores that dot 
communities throughout the state.
  Mr. President, I believe that our plan strikes the right balance as 
we effectively address concerns about quality and choice without 
resorting to unduly burdensome federal controls and mandates that would 
further drive up costs and cause some Americans to lose their health 
insurance altogether. I urge all of my colleagues to join us in 
cosponsoring this proposal.
 Mr. FRIST. Mr. President, I rise to voice my support for the 
bill we are introducing today and to urge my colleagues to pass a 
strong Patients' Bill of Rights this year. Our Patients' Bill of Rights 
is a good bill that will improve the quality of health care for 
patients in this country.

[[Page S921]]

  We have the benefit of starting off in a new Congress. The partisan 
rhetoric of elections is behind us. Today, we are here to convey our 
genuine interest to pass managed care reform this year as well as to 
provide the necessary building blocks to improve health care quality.
  Not much attention was given in last year's debate to the many areas 
of agreement between the Republican and Democratic proposals. It is my 
hope that we can work together this year in a deliberative, thoughtful 
manner to pass bipartisan legislation. For example, there is bipartisan 
support to enact strong patient protection standards including coverage 
for emergency screening exams and services; allowing continuity of care 
so that patients may keep their physician, even if he or she is dropped 
from the plan, during a terminal illness, institutional care or 
pregnancy; and to prohibit plans from including gag clauses in their 
contracts. There is also strong consensus that we must require health 
plans to provide comparative information about their plans and to hold 
plans accountable for their decisions by allowing patients to appeal 
coverage denials to an independent medical expert, including expedited 
reviews, and receive a timely response.
  In addition, I am pleased that many provisions that are in the Senate 
Republican bill also have received bipartisan support. Our bill last 
year included the ``Women's Health Research and Prevention 
Amendments,'' which I also introduced as S. 1722, that passed the 
Senate unanimously at the end of last year. These programs provide a 
broad spectrum of activities to improve the quality of women's health; 
including research, prevention, treatment, education and data 
collection.
  We must remember that the central focus of this debate--the genesis 
for the entire debate--is to embark on a national discussion of how we 
can truly improve real quality of care for patients. Our bill this year 
will again contain two measures which have broad bipartisan support and 
will greatly improve the quality of health care in this country.
  Title III of our bill prohibits genetic discrimination against 
individuals in health insurance. Prohibiting genetic discrimination 
translates into a patient's right to quality care. Genuine quality care 
means that patients and practitioners have the very best information 
available to them when they make health care decisions. Patients should 
not be afraid to benefit from new genetic technologies, or share 
personal information that has immense potential to improve care and 
save lives. This is not a political or partisan issue. Our 49 
Republican cosponsors last year, several of our Democratic colleagues, 
and President Clinton all support enacting legislation to prohibit 
genetic discrimination.
  Title IV of our bill refocuses the Agency for Health Care Policy and 
Research to support our federal efforts to improve health care quality 
through a vigorous research agenda. I also introduced this proposal as 
a stand alone bill (S. 2208) last year which had broad bipartisan 
support. Our goal is to enhance the agency to become the driving force 
of our federal efforts to support the science necessary to provide 
patients with information about the quality of care they receive and to 
provide physicians with research data to improve health care outcomes 
for their patients.
  There is no question Congress will need to revisit some issues in the 
managed care debate. However, we will work deliberatively and in a 
bipartisan manner through our committee work this year to pass 
comprehensive legislation because we all share the ultimate goal of 
improving health care quality for patients.
 Mr. JEFFORDS. Mr. President, I want to begin by commending 
Senator Nickles and all of the members who participated in putting the 
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 Plus.''
  As Chairman of the Committee on Health, Education, Labor, and 
Pensions, with its jurisdiction of private health insurance and public 
health programs, I anticipate that the Committee will have an active 
health care agenda during the 106th Congress. In fact, on January 20th, 
the Committee held a hearing on health plan information requirements 
and internal and external appeals rights. And, this hearing builds on 
the foundation of fourteen related hearings that my Committee held 
during the 105th Congress.
  People need to know what their plan will cover and how they will get 
their health care. The ``Patients' Bill of Rights Plus'' requires full 
information disclosure by an employer about the health plans he or she 
offers to employees. Patients also need to know how adverse decisions 
by the plan can be appealed, both internally and externally, to an 
independent medical reviewer.
  The limited set of standards under the Employee Retirement and Income 
Security Act (ERISA) may have worked well for the simple payment of 
health insurance claims under the fee-for-service system in 1974. 
Today, however, our system is much more complex, and there are many 
types of decisions being made--from routine reimbursements to pre-
authorizations for hospital stays. And it is in the context of these 
changes, particularly the evolution of managed care, that ERISA needs 
to be amended in order to give participants and beneficiaries the right 
to appeal adverse coverage or medical necessity decisions to an 
independent medical expert.
  The provision of our bill giving consumers a new right 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, 
which I introduced with Senator Lieberman during the last Congress. 
Under the ``Patients' Bill of Rights Plus,'' enrollees will get timely 
decisions about what will be covered. Furthermore, if an individual 
disagrees with the plan's decision, that individual may appeal the 
decision to an independent, external reviewer. The reviewer's decision 
will be binding on the health plan. However, the patient maintains his 
or her current rights to go to court.
  As the Health and Education Committee works on health care quality 
legislation, I will keep in mind three goals. First, to give families 
the protections they want and need. Second, to ensure that medical 
decisions are made by physicians in consultation with their patients. 
And, finally, to keep the cost of this legislation low so that it 
displaces no one from getting health care coverage.
  Our goal is to give Americans the protections they want and need in a 
package that they can afford and that we can enact. This is why I hope 
the ``Patients' Bill of Rights Plus'' we have introduced today will be 
enacted and signed into law by the President.
 Mr. CRAIG. Mr. President, today, Senate Republicans are 
responding to America's number one health care concern: the high cost 
of health insurance and medical care. By granting all Americans access 
to tax-free medical savings accounts; by allowing self-employed 
Americans to deduct 100 percent of the cost of their health insurance 
premiums; and by allowing workers with flexible savings accounts to 
keep some of the money in those accounts, our ``Patients' Bill of 
Rights--Plus'' will tear down the barriers that government has put in 
the way of affordable health coverage and care.
  Our proposal stands in stark contrast to those offered by others in 
Congress. With millions of Americans unable to afford insurance because 
of the unfairness of the federal tax code, some members of Congress 
want to force consumers to buy government-prescribed benefits--
including many that are giveaways to special interests--even if it 
causes millions more to lose their health coverage.
  While other so-called ``patients' rights'' bills contain nothing but 
expensive mandates, hidden taxes and costly lawsuits, our bill will 
deliver quality health insurance to millions of Americans. Our bill 
will make a down payment on serious health care reform that puts 
patients first--not doctors, not lawyers, not insurance companies, and 
certainly not government bureaucrats.
  Rather than support a patients' bill of rights minus access, I urge 
my colleagues to take a step forward by making health insurance 
accessible instead of taking a step backward by making it more 
expensive.

[[Page S922]]

 Mr. BURNS. Mr. President, I am pleased to support and co-
sponsor patient protection legislation. There is noting more important 
than protecting the patient-doctor relationship and guaranteeing our 
citizens the right to choose their own doctor. It is important to make 
sure patients have the information they need to make decisions about 
their health care and make sure doctors, not accountants or lawyers, 
decide which medical services are needed.
  Under Senator Nickles' Patients' Bill of Rights Act, no health plan 
will be beyond the scope of federal or state patient safeguards. The 
bill will expand access to doctors, incuding guaranteed access to 
obstetrical and gynecological care and pediatric care, and require 
managed care plans to offer patients the option to receive care outside 
a plan's network of doctors.
  In addition, health plans would have to provide patients with 
information on covered services, cost-sharing requirements, payment 
restrictions for services from out-of-network providers, rules for out-
of-area coverage, preauthorization requirements and procedures, and 
rules for grievence and appeals filings. Health plans would be required 
to have both an internal appeal and external third-party review if 
coverage for any service is denied. Plans would also be required to 
safeguard patients' medical information or face civil penalties.
  The Patients' Bill of Rights Act will also make it easier for many 
Americans to afford health care. Over 3 million self-employed 
individuals and their families will benefit from increasing the tax 
deductibility of health insurance to 100 percent, the same deduction 
most companies take for their employees. This bill also gives every 
American the right to have medical savings accounts (MSAs) and puts 
MSAs on an equal tax treatment footing with standard health care 
insurance. These flexible savings plans allow you to save money for 
health expenses tax-free as long as you have a high-deductible health 
insurance plan. MSAs are currently only available for employees in 
companies with 50 or fewer employees.
  In this era of managed care, patients need a Bill of Rights to make 
sure they get quality health care and not a plan that will lead to 
higher costs and greater numbers of uninsured. I am happy to co-sponsor 
this important legislation.
 Mr. DOMENICI. Mr. President, I rise today in support of the 
recently introduced Republican Patients' Bill of Rights.
  I would like to begin by making an observation about the impact of 
any potential changes to the managed care system.
  I would submit that whether a decision relating to healthcare is made 
by business or the government, the results will always have 
consequences on the those actually utilizing the system. Let me put 
that another way, we must always proceed with what the impact of any 
changes will mean to families and beneficiaries.
  Thus, when decisions are made, they must be thought out and done so 
in a responsible manner. And I believe the Republican Patients' Bill of 
Rights does just that by: holding HMO's accountable, increasing access, 
improving quality and, expanding choice.
  At the same time we must work to ensure that: costs are not 
unnecessarily increased, more Americans are not forced into the ranks 
of the uninsured and, additional layers of bureaucracy are not placed 
between patients and their doctors.
  Let me take just a moment to talk about the state of health care in 
New Mexico.
  Health care is close to a $5 billion a year industry in New Mexico. 
Almost 3,000 physicians practice in the state and overall the industry 
employs close to 52,000 New Mexicans. Over 600,000 New Mexicans are 
enrolled in managed care plans.
  With this in mind, I would like to make several points about New 
Mexico as a whole, that are relevant to any debate relating to managed 
care: 78% of New Mexico businesses have 10 or fewer employees and 96% 
of all businesses have 50 or fewer employees. New Mexico ranks 40th in 
the nation in terms of the number of people uninsured, a full 25% of 
the population.
  The preceding merely emphasizes a point that we must take into 
consideration and that is the potential impact upon a state and its 
people.
  I think everyone would agree that the managed care system is not 
perfect and we have all heard one or another of those so called HMO 
horror stories. As a result, there is now a debate going on here and 
around the country about the need for HMO/Managed Care reform.
  I also want to take a moment to point out that New Mexico is already 
at the forefront of HMO/Managed Care Reform.
  New Mexico has already implemented many of the so called ``patient 
protections'' like: no gag clauses; a prudent layperson standard for 
emergency care; direct access to an OB/GYN; choice of providers; access 
to prescription drugs; confidentiality of medical records and; a 
grievance and appeals procedure.
  I think it is important to stop and make a point that I believe is 
extremely important in light of the large number of small employers and 
high rate of uninsured not only in New Mexico, but the rest of the 
country. For every 1% increase in premium costs, 400,000 individuals 
will lose their health insurance coverage.
  That is an extremely sobering thought when one realizes that small 
employers often have the most difficult time providing insurance for 
their employees because of the already high cost.
  The Republican bill simply addresses Americans' concerns that their 
rights be assured in health care coverage, in addition to increasing 
access to care, improving quality of care, and expanding choice.
  However, there is one thing the Bill will not do, create a new right 
to go into the courts and sue managed care companies for unlimited 
damages. I believe that we on this side of the aisle have adopted a 
sense about health care and it says: lawyers and lawsuits do not 
deliver health care. Rather, lawyers and lawsuits generally make health 
care cost more.
  I also think that it is very important to note that under the 
Employee Retirement Income Security Act (ERISA) a participant or 
beneficiary can already sue a managed care company. Let me repeat that, 
the right to sue a HMO is already available.
  Now why would we want to create even more lawsuits, when for years we 
have been attempting to enact tort reform.
  I know many New Mexicans share in the fears expressed by many 
Americans about the availability and quality of their health care. That 
is why I support the Republican Patients' Bill of Rights because it 
will ensure that patients receive: more affordable care and more 
choices; greater access to more and better information about health 
plans, benefits and the doctors that provide their care; and the 
advantages of a system that holds health plans accountable for medical 
decisions through a strong internal and external appeals process.
  The Bill reforms the Agency for Health Care Policy and Research, 
renaming it the Agency for Healthcare Quality Research (AHQR). It will 
make annual reports on the state of quality and cost of America's 
health care, support primary care research in underserved rural and 
urban areas, provide technology assessment, and coordinate federal 
quality improvement efforts.
  Furthermore, the Bill includes a provision that will prohibit 
insurance plans from using predictive genetic information to deny 
coverage or to set premium rates.
  Finally, the Bill would provide relief to those New Mexicans and 
Americans who are self-employed by allowing them to deduct 100% of 
their health insurance costs. More than 25 million people live in 
families headed by a self-employed individual (5.1 million of whom are 
currently uninsured).
  In closing, I believe that the key to improving our healthcare system 
and to improving our HMO/Managed Care System is to work together.
  As I have said, we must find a solution that would most benefit not 
only New Mexicans, but everyone across our country. However, at the 
same time we must remember that our decisions cannot affect these same 
people in an adverse manner.
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