HIV AIDS Resource Guide/HIV-AIDS Resource Guide.iso/STAT/PROP_FED/HSA05.ASC

Text File | 1993-01-14 | 89KB | 2,186 lines

/* Title V of the proposed Health Security Act follows. */

     Title V   QUALITY AND CONSUMER PROTECTION
Table of Contents

Subtitle A    Quality Management and Improvement

            Section 5001  National Quality Management
            Program Section 5002  National Quality
            Management Council Section 5003  National
            measures of quality
performance

            Section 5004  Consumer surveys

            Section 5005  Evaluation and reporting of
quality performance

            Section 5006  Development and dissemination of

practice guidelines

            Section 5007  Research on health care quality
            Section 5008  Regional professional foundations
            Section 5009  National Quality Consortium
            Section 5010  Eliminating CLIA requirement for
certificate of waiver for simple laboratory examinations
and procedures

            Section 5011  Uniform standards for health care
institutions

            Section 5012  Role of alliances in quality
assurance

            Section 5013  Role of health plans in quality
management

Subtitle B    Information Systems, Privacy, and Administrative
Simplification


    Part 1   Health Information Systems

            Section 5101  Establishment of health information
system

            Section 5102  Additional requirements for health

information system

            Section 5103  Electronic data network

            Section 5104  Unique identifier numbers
            Section 5105  Health security cards
            Section 5106  Technical assistance in
            the
establishment of health information systems

    Part 2   Privacy of Information

            Section 5120  Health information system privacy
standards

            Section 5121  Other duties with respect to privacy
            Section 5122  Comprehensive Health Information
Privacy Protection Act
            Section 5123  Definitions
    Part 3   Interim Requirements for Administrative
Simplification
             Section 5130  Standard benefit forms
    Part 4   General Provisions


            Section 5140  National Privacy and Health Data
Advisory Council

            Section 5141  Civil money penalties

           Section 5142  Relationship to other laws

Subtitle C    Remedies and Enforcement


    Part 1   Review of Benefit Determinations for Enrolled
Individuals


        Sub Part A   GENERAL RULES


          Section 5201  Health plan claims procedure

            Section 5202  Review in regional alliance complaint
review offices of grievances based on acts or practices by
health plans

            Section 5203  Initial proceedings in complaint
review offices

            Section 5204  Hearings before hearing officers in
complaint review offices

            Section 5205  Review by Federal Health Plan Review
Board

            Section 5206  Rules governing benefit claims
determinations

            Section 5207  Civil money penalties

        Sub Part B   EARLY RESOLUTION PROGRAMS

            Section 5211  Establishment of early resolution
programs in complaint review offices

            Section 5212  Initiation of participation in
mediation proceedings

            Section 5213  Mediation proceedings

            Section 5214  Legal effect of participation in
mediation proceedings

            Section 5215  Enforcement of settlement agreements
    Part 2   Additional Remedies and Enforcement Provisions
            Section 5231  Judicial review of Federal action on
State systems
            Section 5232  Administrative and judicial review
relating to cost containment
            Section 5233  Civil enforcement
            Section 5234  Priority of certain bankruptcy claims
            Section 5235  Private right to enforce State
responsibilities
            Section 5236  Private right to enforce Federal
responsibilities in operating a system in a State
            Section 5237  Private right to enforce
responsibilities of alliances

            Section 5238  Discrimination claims

            Section 5239  Nondiscrimination in federally
assisted programs

            Section 5240  Civil action by essential community
provider

            Section 5241  Facial constitutional challenges

            Section 5242  Treatment of plans as parties in
civil actions
            Section 5243  General nonpreemption of existing
rights and remedies

Subtitle D    Medical Malpractice


    Part 1   Liability Reform

            Section 5301  Federal tort reform

            Section 5302  Plan-based alternative dispute
resolution mechanisms

            Section 5303  Requirement for certificate of merit

            Section 5304  Limitation on amount of attorney's
contingency fees

            Section 5305  Reduction of awards for recovery from
collateral sources

           Section 5306  Periodic payment of awards

   Part 2   Other Provisions Relating to Medical Malpractice
Liability

            Section 5311  Enterprise liability demonstration
project

            Section 5312  Pilot program applying practice
guidelines to medical malpractice liability actions

Subtitle E    Fraud and Abuse


   Part 1   Establishment of All-payer Health Care Fraud and
Abuse Control Program

            Section 5401  All-Payer Health Care Fraud and Abuse
Control Program

            Section 5402  Establishment of All-Payer Health
Care Fraud and Abuse Control Account

            Section 5403  Use of funds by Inspector General

    Part 2   Application of Fraud and Abuse Authorities Under
the Social

            Section

          Section 5411  Exclusion from participation

            Section 5412  Civil monetary penalties
            Section 5413  Limitations on physician self-
referral

            Section 5414  Construction of Social Security Act
references


    Part 3   Amendments to Anti-fraud and Abuse Provisions

Under the Social Security Act

             Section 5421  Reference to amendments

    Part 4   Amendments to Criminal Law

            Section 5431  Health care fraud

            Section 5432  Forfeitures for violations of fraud
statutes


            Section 5433  False Statements


            Section 5434  Bribery and graft


            Section 5435  Injunctive relief relating to health
care offenses


            Section 5436  Grand jury disclosure


            Section 5437  Theft or embezzlement


            Section 5438  Misuse of health security card or

unique identifier

    Part 5   Amendments to Civil False Claims Act

            Section 5441  Amendments to Civil False Claims Act

Subtitle F    McCarran-Ferguson Reform

            Section 5501  Repeal of exemption for health
insurance


Subtitle A    Quality Management and Improvement


            Section 5001   NATIONAL QUALITY MANAGEMENT PROGRAM.
    Not later than 1 year after the date of the enactment of
this Act, the National Health Board shall establish and oversee
a performance-based program of quality management and
improvement designed to enhance the quality, appropriateness,
and effectiveness of health care services and access to such
services. The program shall be known as the National Quality
Management Program and shall be administered by the National
Quality Management Council established under section 5002.
            Section 5002   NATIONAL QUALITY MANAGEMENT COUNCIL.
   (a)  Establishment. There is established a council to be
known as the National Quality Management Council.

    (b)  Duties. The Council shall

        (1)  administer the National Quality Management
Program;

        (2)  perform any other duty specified as a duty of the
Council in this subtitle; and

        (3)  advise the National Health Board with respect its
duties under this subtitle.

    (c)  Number and Appointment. The Council shall be composed
of 15 members appointed by the President. The Council shall
consist of members who are broadly representative of the
population of the United States and shall include

        (1)  individuals representing the interests of
governmental and corporate purchasers of health care;

        (2)  individuals representing the interests of health
plans;

        (3)  individuals representing the interests of States;

        (4)  individuals representing the interests of health
care providers and academic health centers (as defined in
section 3101(c)); and

        (5)  individuals distinguished in the fields of public
health, health care quality, and related fields of health
services research.

    (d)  Terms.

        (1)  In general. Except as provided in paragraph (2),
members of the Council shall serve for a term of 3 years.

        (2)  Staggered rotation. Of the members first appointed
to the Council under subsection (c), the President shall
appoint 5 members to serve for a term of 3 years, 5 members to
serve for a term of 2 years, and 5 members to serve for a term
of 1 year.

        (3)  Service beyond term. A member of the Council may
continue to serve after the expiration of the term of the
member until a successor is appointed.

    (e)  Vacancies. If a member of the Council 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 President shall designate an individual to
serve as the chair of the Council.

    (g)  Meetings. The Council shall meet not less than once
during each 4-month period and shall otherwise meet at the call
of the President or the chair.
  (h)  Compensation and Reimbursement of Expenses. Members of
the Council shall receive compensation for each day (including
travel time) engaged in carrying out the duties of the Council.
Such compensation may not be in an amount in excess of the
maximum rate of basic pay payable for level IV of the Executive
Schedule under section 5315 of title 5, United States Code.

    (i)  Staff. The National Health Board shall provide to the
Council such staff, information, and other assistance as may be
necessary to carry out the duties of the Council.

    (j)  Health Care Provider. For purposes of this subtitle,
the term "health care provider" means an individual who, or
entity that, provides an item or service to an individual that
is covered under the health plan (as defined in section 1400)
in which the individual is enrolled.

          Section 5003   NATIONAL MEASURES OF QUALITY
PERFORMANCE.

    (a)  In General. The National Quality Management Council
shall develop a set of national measures of quality
performance, which shall be used to assess the provision of
health care services and access to such services.

    (b)  Subject of Measures. National measures of quality
performance shall be selected in a manner that provides
information on the following subjects:

       (1)  Access to health care services by consumers.

        (2)  Appropriateness of health care services provided
to consumers.
        (3)  Outcomes of health care services and procedures.
        (4)  Health promotion.
        (5)  Prevention of diseases, disorders, and other
health conditions.
        (6)  Consumer satisfaction with care.
    (c)  Selection of Measures.
      (1)  Consultation. In developing and selecting the
national measures of quality performance, the National Quality
Management Council shall consult with appropriate interested
parties, including

            (A)  States;
            (B)  health plans;
            (C)  employers and individuals purchasing health
care through regional and corporate alliances;
            (D)  health care providers;
            (E)  the National Quality Consortium established
under section 5009;
            (F)  individuals distinguished in the fields of
law, medicine, economics, public health, and health services
research;
            (G)  the Administrator for Health Care Policy and
Research;

            (H)  the Director of the National Institutes of
Health; and

            (I)  the Administrator of the Health Care Financing
Administration.

        (2)  Criteria. The following criteria shall be used in
developing and selecting national measures of quality
performance:

            (A)  Significance. When a measure relates to a
specific disease, disorder, or other health condition, the
disease, disorder, or condition shall be of significance in
terms of prevalence, morbidity, mortality, or the costs
associated with the prevention, diagnosis, treatment, or
clinical management of the disease, disorder, or condition.

            (B)  Range of services. The set of measures, taken
as a whole, shall be representative of the range of services
provided to consumers of health care.

            (C)  Reliability and validity. The measures shall
be reliable and valid.

            (D)  Undue burden. The data needed to calculate the
measures shall be obtained without undue burden on the entity
or individual providing the data.

            (E)  Variation. Performance with respect to a
measure shall be expected to vary widely among the individuals
and entities whose performance is assessed using the measure.

            (F)  Linkage to health outcome. When a measure is a
rate of a process of care, the process shall be linked to a
health outcome based upon the best available scientific
evidence.

            (G)  Provider control and risk adjustment. When a
measure is an outcome of the provision of care, the outcome
shall be within the control of the provider and one with
respect to which an adequate risk adjustment can be made.

            (H)  Public health. The measures may incorporate
standards identified by the Secretary of Health and Human
Services for meeting public health objectives.

    (d)  Updating. The National Quality Management Council
shall review and update the set of national measures of quality
performance annually to reflect changing goals for quality
improvement. The Council shall establish and maintain a
priority list of performance measures that within a 5-year
period it intends to consider for inclusion within the set
through the updating process.

            Section 5004   CONSUMER SURVEYS.

    (a)  In General. The National Quality Management Council
shall conduct periodic surveys of health care consumers to
gather information concerning access to care, use of health
services,
health outcomes, and patient satisfaction. The surveys shall
monitor consumer reaction to the implementation of this Act and
be designed to assess the impact of this Act on the general
population of the United States and potentially vulnerable
populations.

  (b)  Survey Administration. The National Quality Management
Council shall develop and approve a standard design for the
surveys, which shall be administered by the Administrator for
Health Care Policy and Research on a plan-by-plan and State-by
State basis. A State may add survey questions on quality
measures of local interest to surveys conducted in the State.

    (c)  Sampling Strategies. The National Quality Management

Council shall develop sampling strategies that ensure that

survey samples adequately measure populations that are

considered to be at risk of receiving inadequate health care

and may be difficult to reach through consumer-sampling

methods, including individuals who

        (1)  fail to enroll in a health plan;

        (2)  resign from a plan; or

         (3)  are members of a vulnerable population.

            Section 5005   EVALUATION AND REPORTING OF QUALITY
PERFORMANCE.


    (a)  National Goals. In subject matter areas with respect
to which the National Quality Management Council determines
that sufficient information and consensus exist, the Council
shall recommend to the Board that the Board establish goals for
performance by health plans and health care providers on a
subset of the set of national measures of quality performance.


    (b)  Impact of Reform. The National Quality Management
Council shall evaluate the impact of the implementation of this
Act on the quality of health care services in the United States
and the access of consumers to such services.


    (c)  Performance Reports.


        (1)  Alliance and health plan reports. Each health
alliance annually shall publish and make available to the
public a performance report outlining in a standard format the
performance of each health plan offered in the alliance on the
set of national measures of quality performance. The report
shall include the results of a smaller number of such measures
for health care providers who are members of provider networks
of such plans (as defined in section 1402(f)), if the available
information is statistically meaningful. The report also shall
include the results of consumer surveys described in section
5004 that were conducted in the alliance area during the year
that is the subject of the report.


        (2)  National quality reports. The National Quality
Management Council annually shall provide to the Congress and
to each health alliance a report that


            (A)  outlines in a standard format the performance
of each regional alliance, corporate alliance, and health plan;


            (B)  discusses State-level and national trends
relating to health care quality; and


            (C)  presents data for each health alliance from
consumer surveys described in section 5004 that were conducted
during the year that is the subject of the report.
    (d)  Public Availability of Information in National
Practitioner Data Bank on Defendants, Awards, and Settlements.
        (1)  In general. Section 427(a) of the Health Care
Quality Improvement Act (42 U.S.C. 11137(a)) is amended by
adding at the end the following new sentence: "Not later than
January 1, 1996, the Secretary shall promulgate regulations
under which individuals seeking to enroll in health plans under
the Health Security Act may obtain information reported under
this part with respect to physicians and other licensed health
practitioners participating in such plans for whom information
has been reported under this part on repeated occasions.".
        (2)  Access to data bank for point-of-service
contractors under medicare. Section 427(a) of such Act (42
U.S.C. 11137(a)) is amended
            (A)  by inserting "to sponsors of point-of-service
networks under section 1890 of the Social Security Act," after
"State licensing boards,", and
            (B)  in the heading, by inserting "Related" after
"Care".
            Section 5006   DEVELOPMENT AND DISSEMINATION OF
PRACTICE
                        GUIDELINES.
    (a)  Development of Guidelines.
        (1)  In general. The National Quality Management
Council shall direct the Administrator for Health Care Policy
and Research to develop and periodically review and update
clinically relevant guidelines that may be used by health care
providers to assist in determining how diseases, disorders, and
other health conditions can most effectively and appropriately
be prevented, diagnosed, treated, and managed clinically.
        (2)  Certain Requirements. Guidelines under paragraph
(1) shall
            (A)  be based on the best available research and
professional judgment regarding the effectiveness and
appropriateness of health care services and procedures;
            (B)  be presented in formats appropriate for use by
health care providers, medical educators, medical review
organizations, and consumers of health care;
            (C)  include treatment-specific or condition-
specific practice guidelines for clinical treatments and
conditions in forms appropriate for use in clinical practice,
for use in educational programs, and for use in reviewing
quality and appropriateness of medical care;
            (D)  include information on risks and benefits of
alternative strategies for prevention, diagnosis, treatment,
and management of a given disease, disorder, or other health
condition;
            (E)  include information on the costs of
alternative strategies for the prevention, diagnosis,
treatment, and
management of a given disease, disorder, or other health
condition, where cost information is available and reliable;
and
            (F)  be developed in accordance with priorities
that shall be established by the National Quality Management
Council based on the research priorities that are established
under section 5007(b) and the 5-year priority list of
performance measures described in section 5003(d).
        (3)  Health service utilization protocols. The National
Quality Management Council shall establish standards and
procedures for evaluating the clinical appropriateness of
protocols used to manage health service utilization.
        (4)  Use in medical malpractice liability pilot
program. Guidelines developed under this subsection may be used
by the Secretary of Health and Human Services in the pilot
program applying practice guidelines to medical malpractice
liability under section 5312.
    (b)  Evaluation and Certification of Other Guidelines.
        (1)  Methodology. The National Quality Management
Council shall direct the Administrator for Health Care Policy
and Research to develop and publish standards relating to
methodologies for developing the types of guidelines described
in subsection (a)(1).
        (2)  Evaluation and certification. The National Quality
Management Council shall direct the Administrator for Health
Care Policy and Research to establish a procedure by which
individuals and entities may submit guidelines of the type
described in subsection (a)(1) to the Council for evaluation
and certification by the Council using the standards developed
under paragraph (1).
        (3)  Use in medical malpractice liability pilot
program. Guidelines certified under paragraph (2) may be used
by the Secretary of Health and Human Services in the pilot
program applying practice guidelines to medical malpractice
liability under section 5312.
    (c)  Guideline Clearinghouse. The National Quality
Management Council shall direct the Administrator for Health
Care Policy and Research to establish and oversee a
clearinghouse and dissemination program for practice guidelines
that are developed or certified under this section.
    (d)  Dissemination of Information on Ineffective
Treatments. The National Quality Management Council shall
collect and disseminate information documenting clinically
ineffective treatments and procedures.
            Section 5007   RESEARCH ON HEALTH CARE QUALITY.
    (a)  Research Support. The National Quality Management
Council shall direct the Administrator for Health Care Policy
and Research to support research directly related to the 5-year
priority list of performance measures described in section
5003(d), including research with respect to
        (1)  outcomes of health care services and procedures;
         (2)  effective and efficient dissemination of
information, standards, and guidelines;

         (3)  methods of measuring quality and shared
decisionmaking; and

        (4)  design and organization of quality of care
components of automated health information systems.

    (b)  Research Priorities. The National Quality Management
Council shall establish priorities for research with respect to
the quality, appropriateness, and effectiveness of health care
and make recommendations concerning research projects. In
establishing the priorities, the National Quality Management
Council shall emphasize research involving diseases, disorders,
and health conditions as to which

        (1)  there is the highest level of uncertainty
concerning treatment;

        (2)  there is the widest variation in practice
patterns;

        (3)  the costs associated with prevention, diagnosis,
treatment, or clinical management are significant; and

        (4)  the rate of incidence or prevalence is high for
the population as a whole or for particular subpopulations.

            Section 5008   REGIONAL PROFESSIONAL FOUNDATIONS.

    (a)  Establishment. The National Health Board shall
establish and oversee regional professional foundations to
perform the duties specified in subsection (c).

    (b)  Structure and Membership.

        (1)  In general. The National Quality Consortium
established under section 5009 shall oversee the establishment
of regional professional foundations, the membership
requirements for each foundation, and any other requirement for
the internal operation of each foundation.

        (2)  Entities eligible for membership. Each regional
professional foundation shall include at least one academic
health center (as defined in section 3101(c)). The following
entities also shall be eligible to serve as members of the
regional professional foundation for the region in which the
entity is located:

            (A)  Schools of public health (as defined in
section 799 of the Public Health Service Act).

            (B)  Other schools and programs defined in such

section.

            (C)  Health plans.

            (D)  Regional alliances.

            (E)  Corporate alliances.

            (F)  Health care providers.

  (c)  Duties. A regional professional foundation shall carry
out the following duties for the region in which the
foundation is located (such region to be demarcated by the
National Health Board with the advice of the National Quality
Consortium established under section 5009):

        (1)  Developing programs in lifetime learning for
health
professionals (as defined in section 1112(c)(1)) to ensure the
delivery of quality health care.

      (2)  Fostering collaboration among health plans and
health care providers to improve the quality of primary and
specialized health care.

        (3)  Disseminating information about successful quality
improvement programs, practice guidelines, and research
findings.

        (4)  Disseminating information on innovative uses of
health professionals.

        (5)  Developing innovative patient education systems
that enhance patient involvement in decisions relating their
health care.

        (6)  Applying for and conducting research described in
section 5007.

    (d)  Programs in Life time Learning.The programs described
in subsection (c)(1) shall ensure that health professionals
remain abreast of new knowledge, acquire new skills, and adopt
new roles as technology and societal demands change.

          Section 5009   NATIONAL QUALITY CONSORTIUM.

    (a)  Establishment. The National Health Board shall
establish a consortium to be known as the National Quality
Consortium.

    (b)  Duties. The Consortium shall

        (1)  establish programs for continuing education for
health professionals;

        (2)  advise the National Quality Management Council and
the Administrator for Health Care Policy and Research on
research priorities;

        (3)  oversee the development of the regional
professional foundations established under section 5008;

        (4)  advise the National Quality Management Council
with respect to the funding of proposals to establish such
foundations;

        (5)  consult with the National Quality Management
Council regarding the selection of national measures of quality
performance under section 5003(c); and

        (6)  advise the National Health Board and the National
Quality Management Council with respect to any other duty of
the Board or the Council under this subtitle.

    (c)  Membership. The Consortium shall be composed of 11
members appointed by the National Health Board. The members of
the Consortium shall include

        (1)  5 individuals representing the interests of
academic health centers; and

        (2)  6 other individuals representing the interests of
one of the following persons:

            (A)  Schools of public health.

            (B)  Other schools and programs defined in section
799 of the Public Health Service Act (including medical
schools, nursing schools, and allied health professional
schools).

    (d)  Terms.

        (1)  In general. Except as provided in paragraph (2),
members of the Consortium shall serve for a term of 3 years.

        (2)  Staggered rotation. Of the members first appointed
to the Consortium under subsection (c), the National Health
Board shall appoint 4 members to serve for a term of 3 years, 3
members to serve for a term of 2 years, and 4 members to serve
for a term of 1 year.

   (e)  Chair. The National Health Board shall designate an
individual to serve as the chair of the Consortium.

            Section 5010   ELIMINATING CLIA REQUIREMENT FOR
CERTIFICATE OF WAIVER FOR SIMPLE LABORATORY EXAMINATIONS AND
PROCEDURES.

    (a)  In General. Section 353 of the Public Health Service
Act (42 U.S.C. 263a) is amended

        (1)  in subsection (b), by inserting before the period
at the end the following: "or unless the laboratory is exempt
from the certificate requirement under subsection (d)(2)";

        (2)  by amending paragraph (2) of subsection (d) to
read as follows:

    "(2) Exemption from certificate requirement for
laboratories performing only simple examinations and
procedures. A laboratory which performs only laboratory
examinations and procedures described in paragraph (3) is not
required to have in effect a certificate under this section.";

        (3)  by striking paragraph (4) of subsection (d); and

        (4)  in subsection (m)(1), by striking ", except that
the Secretary" and all that follows and inserting a period.

    (b)  Effective Date. The amendments made by this section
shall take effect on the first day of the first month beginning
after the date of the enactment of this Act.

            Section 5011   UNIFORM STANDARDS FOR HEALTH CARE
INSTITUTIONS.

    (a)  Development of Standards. Not later than 3 years after
the date of the enactment of this Act, the National Health
Board shall develop  demonstration standards for the licensing
of health care institutions that address essential performance
requirements related to patient care. The standards shall be
developed in a manner that permits them to be applied uniformly
to all such institutions, except in the areas of fire safety,
sanitation, and patient rights, and so as not to undermine
ongoing nursing home reforms.

    (b)  Demonstration Projects. By January 1, 1996, the
National Quality Management Council shall complete
demonstration projects for the standards developed under
subsection (a) and shall revise the standards according to the
findings of such projects. The demonstration projects shall
evaluate the impact of these standards in ensuring quality of
care, reducing cost, and
reducing burdens on health care providers.
    (c)  Preemptive Effect of Fully Implemented Standard. After
a standard developed under this section is tested, evaluated,
revised, and fully implemented, it shall replace existing
standards, except in cases in which statutory changes are
necessary to implement such standards. In such cases, the
National Quality Management Council shall recommend to the
President and the Congress revisions in Federal statutes to
conform the statutes to the standards.
    (d)  Consolidated Audit and Inspection. The National
Quality Management Council shall undertake research efforts
designed to develop a system for carrying out through grant or
contract a single, consolidated annual audit and inspection of
each health care institution and health care provider for the
combined purposes of Federal, State, local, and private
licensure, accreditation, and certification.
          Section 5012   ROLE OF ALLIANCES IN QUALITY
ASSURANCE.

   Each regional alliance and each corporate alliance shall

        (1)  disseminate to consumers information related to
quality and access to aid in their selection of plans in
accordance with section 1325;
        (2)  disseminate information on the quality of health
plans and health care providers contained in reports of the
National Quality Management Council section 5005(c)(2);
        (3)  ensure through negotiations with health plans that
performance and quality standards are continually improved; and
        (4)  conduct educational programs in cooperation with
regional professional foundations to assist consumers in using
quality and other information in choosing health plans.
            Section 5013   ROLE OF HEALTH PLANS IN QUALITY
MANAGEMENT.
    Each health plan shall
        (1)  measure and disclose performance on quality
measures used by
            (A)  participating States in which the plan does
business;
            (B)  regional alliances and corporate alliances
that offer the plan; and
            (C)  the National Quality Management Council;
        (2)  furnish information required under subtitle B of
this title and provide such other reports and information on
the quality of care delivered by health care providers who are
members of a provider network of the plan (as defined in
section 1402(f)) as may be required under this Act; and
         (3)  maintain quality management systems that
            (A)  use the national measures of quality
performance developed by the National Quality Management
Council under section 5003; and

            (B)  measure the quality of health care furnished
to enrollees under the plan by all health care providers who
are members ofa provider network of the plan.

Title V, Subtitle B

Subtitle B    Information Systems, Privacy, and Administrative
Simplification

    Part 1   HEALTH INFORMATION SYSTEMS

            Section 5101   ESTABLISHMENT OF HEALTH INFORMATION
SYSTEM.

    (a)  In General. Not later than 2 years after the date of
the enactment of this Act, the National Health Board shall
develop and implement a health information system by which the
Board shall collect, report, and regulate the collection and
dissemination of the health care information described in
subsection (e) pursuant to standards promulgated by the Board
and (if applicable) consistent with policies established as
part of the National Information Infrastructure Act of 1993.

    (b)  Privacy. The health information system shall be
developed and implemented in a manner that is consistent with
the privacy and security standards established under section
5120.

    (c)  Reduction in Administrative Costs. The health
information system shall be developed and implemented in a
manner that is consistent with the objectives of reducing
wherever practicable and appropriate

        (1)  the costs of providing and paying for health care;

        (2)  the time, effort, and financial resources expended
by persons to provide information to States, the Federal
Government, health alliances, and health plans.

    (d)  Uses of Information. The health care information
described in subsection (e) shall be collected and reported in
a manner that facilitates its use for the following purposes:

        (1)  Health care planning, policy development, policy
evaluation, and research by Federal, State, and local
governments and regional and corporate alliances.

        (2)  Establishing and monitoring payments for health
services by the Federal Government, States, regional alliances,
and corporate alliances.

        (3)  Assessing and improving the quality of health
care.

        (4)  Measuring and optimizing access to health care.

       (5)  Evaluating the cost of specific clinical or
administrative functions.

        (6)  Supporting public health functions and objectives.

        (7)  Improving the ability of health plans, health care
providers, and consumers to coordinate, improve, and make
choices about health care.

        (8)  Managing and containing costs at the alliance and
plan levels.

   (e)  Health Care Information. The health care information
referred to in subsection (a) shall include data on

      (1)  enrollment and disenrollment in health plans;

        (2)  clinical encounters and other items and services
provided by health care providers;

        (3)  administrative and financial transactions and
activities of participating States, regional alliances,
corporate alliances, health plans, health care providers,
employers, and individuals that are necessary to determine
compliance with this Act or an Act amended by this Act;

        (4)  the characteristics of regional alliances,
including the number, and demographic characteristics of
eligible individuals residing in each alliance area;

       (5)  the characteristics of corporate alliances,
including the number, and demographic characteristics of
individuals who are eligible to be enrolled in each corporate
alliance health plan and individuals with respect to whom a
large employer has exercised an option under section 1311 to
make ineligible for such enrollment;

        (6)  terms of agreement between health plans and the
health care providers who are members of provider networks of
the plans (as defined in section 1402(f));

        (7)  payment of benefits in cases in which benefits may
be payable under a health plan and any other insurance policy
or health program;

        (8)  utilization management by health plans and health
care providers;

        (9)  the information collected and reported by the
Board or disseminated by other individuals or entities as part
of the National Quality Management Program under subtitle A;

        (10)  grievances filed against regional alliances,
corporate alliances, and health plans and the resolutions of
such grievances; and

        (11)  any other fact that may be necessary to determine
whether a health plan or a health care provider has complied
with a Federal statute pertaining to fraud or misrepresentation
in the provision or purchasing of health care or in the
submission of a claim for benefits or payment under a health
plan.

            Section 5102   ADDITIONAL REQUIREMENTS FOR HEALTH
INFORMATION SYSTEM.

   (a)  Consultation. The health information system shall be
developed in consultation with

        (1)  Federal agencies that

             (A)  collect health care information;

            (B)  oversee the collection of information or
records management by other Federal agencies;

          (C)  directly provide health care services;

            (D)  provide for payments for health care services;
or

            (E)  enforce a provision of this Act or any Act
amended by this Act;

        (2)  the National Quality Management Council

established under section 5002;

        (3)  participating States;

       (4)  regional alliances and corporate alliances;

        (5)  health plans;

        (6)  representatives of health care providers;

        (7)  representatives of employers;

       (8)  representatives of consumers of health care;

        (9)  experts in public health and health care
information and technology; and


        (10)  representatives of organizations furnishing
health care supplies, services, and equipment.


    (b)  Collection and Transmission Requirements.In
establishing standards under section 5101, the National Health
Board shall specify the form and manner in which individuals
and entities are required to collect or transmit health care
information for or to the Board. The Board also shall specify
the frequency with which individuals and entities are required
to transmit such information to the Board. Such specifications
shall include, to the extent practicable


        (1)  requirements for use of uniform paper forms
containing standard data elements, definitions, and
instructions for completion in cases where the collection or
transmission of data in electronic form is not specified by the
Board;


        (2)  requirements for use of uniform health data sets
with common definitions to standardize the collection and
transmission of data in electronic form;


      (3)  uniform presentation requirements for data in
electronic form; and

        (4)  electronic data interchange requirements for the
exchange of data among automated health information systems.

    (c)  Preemption of State "Pen & Quill" Laws. A standard
established by the National Health Board relating to the form
in which medical or health plan records are required to be
maintained shall supercede any contrary provision of State law,
except where the Board determines that the provision is
necessary to prevent fraud and abuse, with respect to
controlled substances, or for other purposes.

            Section 5103   ELECTRONIC DATA NETWORK.

    (a)  In General. As part of the health information system,
the National Health Board shall oversee the establishment of an
electronic data network consisting of regional centers that
collect, compile, and transmit information.

    (b)  Consultation. The electronic data network shall be
developed in consultation with

        (1)  Federal agencies that

             (A)  collect health care information;

            (B)  oversee the collection of information or
records management by other Federal agencies;

          (C)  directly provide health care services;

            (D)  provide for payments for health care services;
or

            (E)  enforce a provision of this Act or any Act
amended by this Act;

        (2)  the National Quality Management Council

established under section 5002;

        (3)  participating States;

       (4)  regional alliances and corporate alliances;

        (5)  health plans;

        (6)  representatives of health care providers;

        (7)  representatives of employers;

       (8)  representatives of consumers of health care;

        (9)  experts in public health and health care
information and technology; and


        (10)  representatives of organizations furnishing
health care supplies, services, and equipment.


   (c)  Demonstration Projects. The electronic data network
shall be tested prior to full implementation through the
establishment of demonstration projects.

    (d)  Disclosure of Individually Identifiable Information.
The electronic data network may be used to disclose
individually identifiable health information (as defined in
section 5123(3)) to any individual or entity only in accordance
with the health information system privacy standards
promulgated by the National Health Board under section 5120.

           Section 5104   UNIQUE IDENTIFIER NUMBERS.

  (a)  In General. As part of the health information system,
the Board shall establish a system to provide for a unique

identifier number for each

        (1)  eligible individual;

        (2)  employer;

        (3)  health plan; and

        (4)  health care provider.

    (b)  Impermissible Data Links. In establishing the system
under subsection (a), the National Health Board shall ensure
that
a unique identifier number may not be used to connect
individually identifiable health information (as defined in
section 5123(3)) that is collected as part of the health
information system or that otherwise may be accessed through
the number with individually identifiable information from any
other source, except in cases where the National Health Board
determines that such connection is necessary to carry out a
duty imposed on any individual or entity under this Act.

   (c)  Permissible Uses of Identifier. The National Health
Board shall by regulation establish the purposes for which a
unique identifier number provided pursuant to this section may
be used.

             Section 5105   HEALTH SECURITY CARDS.

    (a)  Permissible Uses of Card. A health security card that
is issued to an eligible individual under section 1001(b) may
be used by an individual or entity, in accordance with
regulations promulgated by the Board, only for the purpose of
providing or assisting the eligible individual in obtaining an
item or service that is covered under

        (1)  the applicable health plan in which the individual
is enrolled (as defined in section 1902);

        (2)  a policy consisting of a supplemental health
benefit policy (described in part 2 of subtitle E of title I),
a cost sharing policy (described in such part), or both;

        (3)  a FEHBP supplemental plan (described in subtitle C
of title VIII);

        (4)  a FEHBP medicare supplemental plan (described in
such subtitle); or

      (5)  such other programs as the Board may specify.

    (b)  Form of Card and Encoded Information. The National
Health Board shall establish standards respecting the form of
health security cards and the information to be encoded in
electronic form on the cards. Such information shall include

        (1)  the identity of the individual to whom the card is
issued;

        (2)  the applicable health plan in which the individual
is enrolled;

        (3)  any policy described in paragraph (2), (3), or (4)
of subsection (a) in which the individual is enrolled; and

        (4)  any other information that the National Health
Board determines to be necessary in order for the card to serve
the purpose described in subsection (a).

    (c)  Unique Identifier Numbers. The unique identifier
number system developed by the National Health Board under
section 5104 shall be used in encoding the information
described in subsection (b).

  (d)  Registration of Card. The Board shall take appropriate
steps to register the card, the name of the card, and other
indicia relating to the card as a trademark or service mark (as
appropriate) under the Trademark Act of 1946. For purposes of
this subsection, the "Trademark Act of 1946" refers to the Act
entitled "An Act to provide for the registration and protection
of trademarks used in commerce, to carry out the provisions of
international conventions, and for other purposes", approved
July 5, 1946 (15 U.S.C. et seq.).

    (e)  Reference to Crime. For a provision relating to
criminal penalties for misuse of a health security card or a
unique identifier number, see section 5438.

          Section 5106   TECHNICAL ASSISTANCE IN THE
ESTABLISHMENT OF HEALTH INFORMATION SYSTEMS.

    The National Health Board shall provide information and
technical assistance to participating States, regional
alliances, corporate alliances, health plans, and health care
providers with respect to the establishment and operation of
automated health information systems. Such assistance shall
focus on (1)  the promotion of community-based health
information systems; and

        (2)  the promotion of patient care information systems
that collect data at the point of care or as a by-product of
the delivery of care.

    Part 2   PRIVACY OF INFORMATION

            Section 5120   HEALTH INFORMATION SYSTEM PRIVACY
STANDARDS.

    (a)  Health Information System Standards. Not later than 2
years after the date of the enactment of this Act, the National
Health Board shall promulgate standards respecting the privacy
of individually identifiable health information that is in the
health information system described in part 1 of this subtitle.
Such standards shall include standards concerning safeguards
for the security of such information. The Board shall develop
and periodically revise the standards in consultation with

        (1)  Federal agencies that

             (A)  collect health care information;

            (B)  oversee the collection of information or
records management by other Federal agencies;

          (C)  directly provide health care services;

            (D)  provide for payments for health care services;
or

            (E)  enforce a provision of this Act or any Act
amended by this Act;

        (2)  the National Quality Management Council

established under section 5002;

        (3)  participating States;

       (4)  regional alliances and corporate alliances;

        (5)  health plans; and

        (6)  representatives of consumers of health care.

  (b)  Information Covered. The standards established under
subsection (a) shall apply to individually identifiable
health information collected for or by, reported to or by,
or the
dissemination of which is regulated by, the National Health
Board under section 5101.
   (c)  Principles. The standards established under subsection
(a) shall incorporate the following principles:

        (1)  Unauthorized disclosure. All disclosures of
individually identifiable health information by an individual or
entity shall be unauthorized unless
            (A)  the disclosure is by the enrollee identified in
the information or whose identity can be associated with the
information;
            (B)  the disclosure is authorized by such enrollee
in writing in a manner prescribed by the Board;
            (C)  the disclosure is to Federal, State, or local
law enforcement agencies for the purpose of enforcing this Act
or an Act amended by this Act; or
            (D)  the disclosure otherwise is consistent with
this Act and specific criteria governing disclosure established
by the Board.
        (2)  Minimal disclosure.All disclosures of individually
identifiable health information shall be restricted to the
minimum amount of information necessary to accomplish the
purpose for which the information is being disclosed.
        (3)  Risk adjustment. No individually identifiable
health information may be provided by a health plan to a
regional alliance or a corporate alliance for the purpose of
setting premiums based on risk adjustment factors.
/* A very important change in previous attitudes towards health
care. The principal of universiality is clear. In addition, the
Health Security Act as clear in insuring that the information is
not even available for the individual underwriting of insurance.
*/
        (4)  Required safeguards. Any individual or entity who
maintains, uses, or disseminates individually identifiable
health information shall implement administrative, technical,
and physical safeguards for the security of such information.
         (5)  Right to know. An enrollee (or an enrollee
representative of the enrollee) has the right to know

            (A)  whether any individual or entity uses or
maintains individually identifiable health information
concerning the enrollee; and

            (B)  for what purposes the information may be used
or maintained.

        (6)  Right to access. Subject to appropriate procedures,
an enrollee (or an enrollee representative of the enrollee) has
the right, with respect to individually identifiable health
information concerning the enrollee that is recorded in any form
or medium

            (A)  to see such information;

            (B)  to copy such information; and

            (C)  to have a notation made with or in such
information of any amendment or correction of such information
requested by the enrollee or enrollee representative.
        (7)  Right to notice. An enrollee and an enrollee
representative have the right to receive a written statement
concerning

            (A)  the purposes for which individually
identifiable health information provided to a health care
provider, a health plan, a regional alliance, a corporate
alliance, or the National Health Board may be used or disclosed
by, or disclosed to, any individual or entity; and

            (B)  the right of access described in paragraph (6).

        (8)  Use of Unique Identifier. When individually
identifiable health information concerning an enrollee is
required to accomplish the purpose for which information is
being transmitted between or among the National Health Board,
regional and corporate alliances, health plans, and health care
providers, the transmissions shall use the unique identifier
number provided to the enrollee pursuant to section 5104 in lieu
of the name of the enrollee.

        (9)  Use for Employment Decisions. Individually
identifiable health care information may not be used in making
employment decisions.

            Section 5121   OTHER DUTIES WITH RESPECT TO PRIVACY.

    (a)  Research and Technical Support. The National Health
Board may sponsor

        (1)  research relating to the privacy and security of
individually identifiable health information;

         (2)  the development of consent forms governing
disclosure of such information; and

        (3)  the development of technology to implement
standards regarding such information.

    (c)  Education. The National Health Board shall establish
education and awareness programs

        (1)  to foster adequate security practices by States,
regional alliances, corporate alliances, health plans, and
health care providers;

        (2)  to train personnel of public and private entities
who have access to individually identifiable health information
respecting the duties of such personnel with respect to such
information; and

        (3)  to inform individuals and employers who purchase
health care respecting their rights with respect to such
information.

            Section 5122   COMPREHENSIVE HEALTH INFORMATION
PRIVACY PROTECTION ACT.

    (a)  In General. Not later than 3 years after the date of
the enactment of this Act, the National Health Board shall
submit to the President and the Congress a detailed proposal for
legislation to provide a comprehensive scheme of Federal privacy
protection for individually identifiable health information.

    (b)  Code of Fair Information Practices. The proposal shall
include a Code of Fair Information Practices to be used to
advise enrollees to whom individually identifiable health
information pertains of their rights with respect to such
information in an easily understood and useful form.

    (c)  Enforcement. The proposal shall include provisions to
enforce effectively the rights and duties that would be created
by the legislation.

            Section 5123   DEFINITIONS.

    For purposes of this part:

        (1)  Enrollee. The term "enrollee" means an individual
who enrolls or has enrolled under a health plan. The term
includes a deceased individual who was enrolled under a health
plan.

        (2)  Enrollee representative. The term "enrollee
representative" means any individual legally empowered to make
decisions concerning the provision of health care to an enrollee
or the administrator or executor of the estate of a deceased
enrollee.

        (3)  Individually identifiable health information. The
term "individually identifiable health information" means any
information, whether oral or recorded in any form or medium,
that-

            (A)  identifies or can readily be associated with
the identity of an enrollee; and

            (B)  relates to

   (i)  the past, present, or future physical or mental health
of the enrollee;

     (ii)  the provision of health care to the enrollee; or

     (iii)  payment for the provision of health care to the
enrollee.

    Part 3   INTERIM REQUIREMENTS FOR ADMINISTRATIVE
SIMPLIFICATION

             Section 5130   STANDARD BENEFIT FORMS.

  (a)  Development. Not later than 1 year after the date of the
enactment of this Act, the National Health Board shall develop,
promulgate, and publish in the Federal Register the following
standard health care benefit forms:

        (1)  An enrollment and disenrollment form to be used to
record enrollment and disenrollment in a health benefit plan.

      (2)  A clinical encounter record to be used by health
benefit plans and health service providers.

        (3)  A claim form to be used in the submission of claims
for benefits or payment under a health benefit plan.

  (b)  Instructions, Definitions, and Codes. Each standard form
developed under subsection (a) shall include instructions for
completing the form that
        (1)  specifically define, to the extent practicable,
the data elements contained in the form; and
        (2)  standardize any codes or data sets to be used in
completing the form.
    (c)  Requirements for Adoption of Forms.
        (1)  Health service providers. On or after the date
that is 270 days after the publication of the standard forms
developed under subsection (a), a health service provider that
furnishes items or services in the United States for which
payment may be made under a health benefit plan may not
            (A)  maintain records of clinical encounters
involving such items or services that are required to be
maintained by the National Health Board in a paper form that is
not the clinical encounter record promulgated by the Board; or
            (B)  submit any claim for benefits or payment for
such services to such plan in a paper form that is not the
claim form promulgated by the National Health Board.
        (2)  Health benefit plans. On or after the date that is
270 days after the publication of the standard forms developed
under subsection (a), a health benefit plan may not
            (A)  record enrollment and disenrollment in a paper
form that is not the enrollment and disenrollment form
promulgated by the National Health Board;
            (B)  maintain records of clinical encounters that
are required to be maintained by the National Health Board in a
paper form that is not the clinical encounter record
promulgated by the Board; or
            (C)  reject a claim for benefits or payment under
the plan on the basis of the form or medium in which the claim
is submitted if
    (i)  the claim is submitted on the claim form promulgated

by the National Health Board; and

    (ii)  the plan accepts claims submitted in paper form.

    (d)  Definitions.For purposes of this subtitle:

        (1)  Health benefit plan.

            (A)  In general. The term "health benefit plan"
means, except as provided in subparagraphs (B) through (D), any
public or private entity or program that provides for payments
for health care services, including


    (i)  a group health plan (as defined in section 5000(b)(1)
of the Internal Revenue Code of 1986); and


    (ii)  any other health insurance arrangement, including any
arrangement consisting of a hospital or medical expense
incurred policy or certificate, hospital or medical service
plan contract, or health maintenance organization subscriber
contract.


            (B)  Plans excluded. Such term does not include


  (i)  accident-only, credit, or disability income insurance;


    (ii)  coverage issued as a supplement to liability
insurance;


  (iii)  an individual making payment on the individual's own
behalf (or on behalf of a relative or other individual) for
deductibles, coinsurance, or services not covered under a
health benefit plan; and

    (iv)  such other plans as the National Health Board may
determine, because of the limitation of benefits to a single
type or kind of health care, such as dental services or
hospital indemnity plans, or other reasons should not be
subject to the requirements of this section.

            (C)  Plans included. Such term includes

    (i)  workers compensation or similar insurance insofar as
it relates to workers compensation medical benefits (as defined
in section 10000(3)) provided by or through health plans; and

  (ii)  automobile medical insurance insofar as it relates to
automobile insurance medical benefits (as defined in section
10100(2)) provided by or through health plans.

            (D)  Treatment of direct provision of services.Such
term does not include a Federal or State program that provides
directly for the provision of health services to beneficiaries.

        (2)  Health service provider. The term "health service
provider" includes a provider of services (as defined in
section 1861(u) of the Social Security Act), physician,
supplier, and other person furnishing health care services.
Such term includes a Federal or State program that provides
directly for the provision of health services to beneficiaries.

   (e)  Interim Nature of Requirements. The National Health
Board may modify, update, or supercede any standard form or
requirement developed, promulgated, or imposed under this
section through the establishment of a standard under section
5101.

    Part 4   GENERAL PROVISIONS

            Section 5140   NATIONAL PRIVACY AND HEALTH DATA
ADVISORY COUNCIL.

    (a)  Establishment. There is established an advisory
council to be known as the National Privacy and Health Data
Advisory Council.

   (b)  Duties. The Council shall advise the National Health
Board with respect its duties under this subtitle.

    (c)  Number and Appointment. The Council shall be composed
of 15 members appointed by the National Health Board. The
members of the Council shall include

        (1)  individuals representing the interests of
consumers, employers, and other purchasers of health care;

        (2)  individuals representing the interests of health
plans, health care providers, corporate alliances, regional
alliances, public health agencies, and participating States;
and

        (3)  individuals distinguished in the fields of data
collection, data protection and privacy, law, ethics, medical
and
health services research, public health, and civil liberties
and patient advocacy.
    (d)  Terms.
        (1)  In general. Except as provided in paragraph (2),
members of the Council shall serve for a term of 3 years.
        (2)  Staggered rotation. Of the members first appointed
to the Council under subsection (c), the National Health Board
shall appoint 5 members to serve for a term of 3 years, 5
members to serve for a term of 2 years, and 5 members to serve
for a term of 1 year.
        (3)  Service beyond term. A member of the Council may
continue to serve after the expiration of the term of the
member until a successor is appointed.
    (e)  Vacancies. If a member of the Council 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 National Health Board shall designate an
individual to serve as the chair of the Council.

    (g)  Meetings. The Council shall meet not less than once
during each 4-month period and shall otherwise meet at the call
of the National Health Board or the chair.

  (h)  Compensation and Reimbursement of Expenses. Members of
the Council shall receive compensation for each day (including
travel time) engaged in carrying out the duties of the Council.
Such compensation may not be in an amount in excess of the
maximum rate of basic pay payable for level IV of the Executive
Schedule under section 5315 of title 5, United States Code.

    (i)  Staff. The National Health Board shall provide to the
Council such staff, information, and other assistance as may be
necessary to carry out the duties of the Council.

  (j)  Duration. Notwithstanding section 14(a) of the Federal
Advisory Committee Act, the Council shall continue in existence
until otherwise provided by law.

             Section 5141   CIVIL MONEY PENALTIES.

    (a)  Violation of Health Information System Standards. Any
person who the Secretary of Health and Human Services
determines

        (1)  is required, but has substantially failed, to
comply with a standard established by the National Health Board
under section 5101 or 5120;

        (2)  has required the display of, has required the use
of, or has used a health security card for any purpose other
than a purpose described in section 5105(a); or

        (3)  has required the disclosure of, has required the
use of, or has used a unique identifier number provided
pursuant to section 5104 for any purpose that is not authorized
by the National Health Board pursuant to such section shall be
subject, in addition to any other penalties that may be
prescribed by law, to a civil money penalty of not more than
$10,000 for each such violation.

  (b)  Standard Benefit Forms. Any health service provider or
health benefit plan that the Secretary of Health and Human
Services determines is required, but has substantially failed,
to comply with section 5130(c) shall be subject, in addition to
any other penalties that may be prescribed by law, to a civil
money penalty of not more than $10,000 for each such violation.

    (c)  Process. The process for the imposition of a civil
money penalty under the All-Payer Health Care Fraud and Abuse
Control Program under part 1 of subtitle E of this title shall
apply to a civil money penalty under this section in the same
manner as such process applies to a penalty or proceeding under
such program.
          Section 5142   RELATIONSHIP TO OTHER LAWS.
  (a)  Court Orders. Nothing in this title shall be construed
to invalidate or limit the power or authority of any court of
competent jurisdiction with respect to health care information.

    (b)  Public Health Reporting. Nothing in this title shall
be construed to invalidate or limit the authorities, powers, or
procedures established under any law that provides for the
reporting of disease, child abuse, birth, or death.

Title V, Subtitle C

Subtitle C    Remedies and Enforcement

    Part 1   REVIEW OF BENEFIT DETERMINATIONS FOR ENROLLED
INDIVIDUALS

        Subpart A    General Rules

            Section 5201   HEALTH PLAN CLAIMS PROCEDURE.

    (a)  Definitions.For purposes of this section

        (1)  Claim.The term "claim" means a claim for payment
or provision of benefits under a health plan or a request for
preauthorization of items or services which is submitted to a
health plan prior to receipt of the items or services.


        (2)  Individual claimant. The term "individual
claimant" with respect to a claim means any individual who
submits the claim to a health plan in connection with the
individual's enrollment under the plan, or on whose behalf the
claim is submitted to the plan by a provider.


        (3)  Provider claimant. The term "provider claimant"
with respect to a claim means any provider who submits the
claim to a health plan with respect to items or services
provided to an individual enrolled under the plan.


    (b)  General Rules Governing Treatment of Claims.


        (1)  Adequate notice of disposition of claim. In any
case in which a claim is submitted in complete form to a health
plan, the plan shall provide to the individual claimant and any
provider claimant with respect to the claim a written notice of
the plan's approval or denial of the claim within 30 days after
the date of the submission of the claim. The notice to the
individual claimant shall be written in language calculated to
be understood by the typical individual enrolled under the plan
and in a form which takes into account accessibility to the
information by individuals whose primary language is not
English. In the case of a denial of the claim, the notice shall
be
provided within 5 days after the date of the determination to
deny the claim, and shall set forth the specific reasons for
the denial. The notice of a denial shall include notice of the
right to appeal the denial under paragraph (2). Failure by any
plan to comply with the requirements of this paragraph with
respect to any claim submitted to the plan shall be treated as
approval by the plan of the claim.

        (2)  Plan's duty to review denials upon timely request.
The plan shall review its denial of the claim if an individual
claimant or provider claimant with respect to the claim submits
to the plan a written request for reconsideration of the claim
after receipt of written notice from the plan of the denial.
The plan shall allow any such claimant not less than 60 days,
after receipt of written notice from the plan of the denial, to
submit the claimant's request for reconsideration of the claim.

        (3)  Time limit for review. The plan shall complete any
review required under paragraph (2), and shall provide the
individual claimant and any provider claimant with respect to
the claim written notice of the plan's decision on the claim
after reconsideration pursuant to the review, within 30 days
after the date of the receipt of the request for
reconsideration.

        (4)  De novo reviews. Any review required under
paragraph (2)

            (A)  shall be de novo,

            (B)  shall be conducted by an individual who did
not make the initial decision denying the claim and who is
authorized to approve the claim, and

            (C)  shall include review by a qualified physician
if the resolution of any issues involved requires medical
expertise.

    (c)  Treatment of Urgent Requests to Plans for
Preauthorization.

        (1)  In general. This subsection applies in the case of
any claim submitted by an individual claimant or a provider
claimant consisting of a request for preauthorization of items
or services (other than emergency services which under section
1406(b) may not be subject to preauthorization) which is
accompanied by an attestation that

            (A)  failure to immediately provide the items or
services could reasonably be expected to result in

    (i)  placing the health of the individual claimant (or,
with respect to an individual claimant who is a pregnant woman,
the health of the woman or her unborn child) in serious
jeopardy,

    (ii)  serious impairment to bodily functions, or

  (iii)  serious dysfunction of any bodily organ or part, or

            (B)  immediate provision of the items or services
is necessary because the individual claimant has made or is at
serious risk of making an attempt to harm such individual
claimant or another individual.

        (2)  Shortened time limit for consideration of requests
for preauthorization.Notwithstanding subsection (b)(1), a
health plan shall approve or deny any claim described in
paragraph (1) within 24 hours after submission of the claim to
the plan.
Failure by the plan to comply with the requirements of this
paragraph with respect to the claim shall be treated as
approval by the plan of the claim.

        (3)  Expedited exhaustion of plan remedies. Any claim
described in paragraph (1) which is denied by the plan shall be
treated as a claim with respect to which all remedies under the
plan provided pursuant to this section are exhausted,
irrespective of any review provided under subsection (b)(2).

        (4)  Denial of previously authorized claims not
permitted. In any case in which a health plan approves a claim
described in paragraph (1)

            (A)  the plan may not subsequently deny payment or
provision of benefits pursuant to the claim, unless the plan
makes a showing of an intentional misrepresentation of a
material fact by the individual claimant, and

            (B)  in the case of a violation of subparagraph (A)
in connection with the claim, all remedies under the plan
provided pursuant to this section with respect to the claim
shall be treated as exhausted.

    (d)  Time Limit for Determination of Incompleteness of
Claim. For purposes of this section

        (1)  any claim submitted by an individual claimant and
accepted by a provider serving under contract with a health
plan and any claim described in subsection (b)(1) shall be
treated with respect to the individual claimant as submitted in
complete form, and

        (2)  any other claim for benefits under the plan shall
be treated as filed in complete form as of 10 days after the
date of the submission of the claim, unless the plan provides
to the individual claimant and any provider claimant, within
such period, a written notice of any required matter remaining
to be filed in order to complete the claim. Any filing by the
individual claimant or the provider claimant of additional
matter requested by the plan pursuant to paragraph (2) shall be
treated for purposes of this section as an initial filing of
the claim.

    (e)  Additional Notice and Disclosure Requirements for
Health Plans. In the case of a denial of a claim for benefits
under a health plan, the plan shall include, together with the
specific reasons provided to the individual claimant and any
provider claimant under subsection (b)(1)

        (1)  if the denial is based in whole or in part on a
determination that the claim is for an item or service which is
not covered by the comprehensive benefit package or exceeds
payment rates under the applicable alliance or State fee
schedule, the factual basis for the determination,

      (2)  if the denial is based in whole or in part on
exclusion of coverage with respect to services because the
services are determined to comprise an experimental treatment
or investigatory procedure, the medical basis for the
determination and a description of the process used in making
the determination, and

/* An important potential right for those with AIDS seeking
treatments which may not have had time for acceptance under the
tradional means of proving health treatments. */

        (3)  if the denial is based in whole or in part on a
determination that the treatment is not medically necessary or
appropriate or is inconsistent with the plan's practice
guidelines, the medical basis for the determination, the
guidelines used in making the determination, and a description
of the process used in making the determination.

    (f)  Waiver of Rights Prohibited. A health plan may not
require any party to waive any right under the plan or this Act
as a condition for approval of any claim under the plan, except
to the extent otherwise specified in a formal settlement
agreement.

            Section 5202   REVIEW IN REGIONAL ALLIANCE
COMPLAINT REVIEW OFFICES OF GRIEVANCES BASED ON ACTS OR
PRACTICES BY HEALTH PLANS.

    (a)  Complaint Review Offices.

        (1)  In general. In accordance with rules which shall
be prescribed by the Secretary of Labor, each State shall
establish and maintain a complaint review office for each
regional alliance established by such State. According to
designations which shall be made by each State under
regulations of the Secretary of Labor, the complaint review
office for a regional alliance established by such State shall
also serve as the complaint review office for corporate
alliances operating in the State with respect to individuals
who are enrolled under plans described in subsection (b)
maintained by such corporate alliances and who reside within
the area of the regional alliance.

        (2)  Regional alliances not established by States.In
the case of any regional alliance established in any State by
the Secretary of Health and Human Services, the Secretary of
Health and Human Services shall assume all duties and
obligations of such State under this part in accordance with
the applicable regulations of the Secretary of Labor under this
part.

    (b)  Filings of Complaints by Aggrieved Persons. In the
case of any person who is aggrieved by

        (1)  any act or practice engaged in by any health plan
which consists of or results in denial of payment or provision
of benefits under the plan or delay in the payment or provision
of benefits, or

        (2)  any act or practice engaged in by any other plan
maintained by a regional alliance or a corporate alliance which
consists of or results in denial of payment or provision of
benefits under a supplemental benefit policy described in
section 1421(b)(1) or a cost sharing policy described in
section 1421(b)(2) or delay in the payment or provision of the
benefits, if the denial or delay consists of a failure to
comply with the terms of the plan (including the provision of
benefits in full when due in accordance with the terms of the
plan), or with the applicable requirements of this Act, such
person may file a complaint with the appropriate complaint
review office.

  (c)  Exhaustion of Plan Remedies. Any complaint including a
claim to which section 5201 applies may not be filed until the
complainant has exhausted all remedies provided under the plan
with respect to the claim in accordance with such section.

    (d)  Exclusive Means of Review for Plans Maintained by
Corporate Alliances. Notwithstanding part 2, proceedings under
sections 5203 and 5204 pursuant to complaints filed under
subsection (b), and review under section 5205 of determinations
made under section 5204, shall be the exclusive means of review
of acts or practices described in subsection (b) which are
engaged in by a corporate alliance health plan or by any plan
maintained by a corporate alliance with respect to benefits
under a supplemental benefit policy described in section
1421(b)(1) or a cost sharing policy described in section
1421(b)(2).

   (e)  Form of Complaint. The complaint shall be in writing
under oath or affirmation, shall set forth the complaint in a
manner calculated to give notice of the nature of the
complaint, and shall contain such information as may be
prescribed in regulations of the Secretary of Labor.

    (f)  Notice of Filing. The complaint review office shall
serve by certified mail a notice of the complaint (including
the date, place, and circumstances of the alleged violation) on
the person or persons alleged in the complaint to have
committed the violation within 10 days after the filing of the
complaint.

    (g)  Time Limitation. Complaints may not be brought under
this section with respect to any violation later than one year
after the date on which the violation occurs. This subsection
shall not prevent the subsequent amending of a complaint.

            Section 5203   INITIAL PROCEEDINGS IN COMPLAINT
REVIEW OFFICES.

    (a)  Elections. Whenever a complaint is brought to the
complaint review office under section 5202(b), the complaint
review office shall provide the complainant with an
opportunity, in such form and manner as shall be prescribed in
regulations of the Secretary of Labor, to elect one of the
following:

      (1)  to forego further proceedings in the complaint
review office and rely on remedies available in a court of
competent jurisdiction, with respect to any matter in the
complaint with respect to which proceedings under this section
and section 5204, and review under section 5205, are not under
section 5202(d) the exclusive means of review,

        (2)  to submit the complaint as a dispute under the
Early Resolution Program established under subpart B and
thereby suspend further review proceedings under this section
pending termination of proceedings under the Program, or

        (3)  in any case in which an election under paragraph
(2) is not made, or such an election was made but resolution of
all matters in the complaint was not obtained upon termination
of proceedings pursuant to the election by settlement agreement
or otherwise, to proceed with the complaint to a hearing in the
complaint review office under section 5204 regarding the
unresolved matters.

    (b)  Effect of Participation in Early Resolution Program.
Any matter in a complaint brought to the complaint review
office which is included in a dispute which is timely submitted
to the Early Resolution Program established under subpart B
shall not be assigned to a hearing under section 5204 unless
the proceedings under the Program with respect to the dispute
are terminated without settlement or resolution of the dispute
with respect to such matter. Upon termination of any
proceedings regarding a dispute submitted to the Program, the
applicability of this section to any matter in a complaint
which was included in the dispute shall not be affected by
participation in the proceedings, except to the extent
otherwise required under the
terms of any settlement agreement or other formal resolution
obtained in the proceedings.

            Section 5204   HEARINGS BEFORE HEARING OFFICERS IN
COMPLAINT REVIEW OFFICES.

    (a)  Hearing Process.

        (1)  Assignment of complaints to hearing officers and
notice to parties.

            (A)  In general. In the case of an election under
section 5203(a)(3)

    (i)  the complaint review office shall assign the
complaint, and each motion in connection with the complaint, to
a hearing officer employed by the State in the office; and

    (ii)  the hearing officer shall have the power to issue and
cause to be served upon the plan named in the complaint a copy
of the complaint and a notice of hearing before the hearing
officer at a place fixed in the notice, not less than 5 days
after the serving of the complaint.

            (B)  Qualifications for hearing officers. No
individual may serve in a complaint review office as a hearing
officer unless the individual meets standards which shall be
prescribed by the Secretary of Labor. Such standards shall
include experience, training, affiliations, diligence, actual
or potential conflicts of interest, and other qualifications
deemed relevant by the Secretary of Labor. At no time shall a
hearing officer have any official, financial, or personal
conflict of interest with respect to issues in controversy
before the hearing officer.

        (2)  Amendment of complaints. Any such complaint may be
amended by the hearing officer conducting the hearing, upon the
motion of the complainant, in the hearing officer's discretion
at any time prior to the issuance of an order based thereon.

        (3)  Answers. The party against whom the complaint is
filed shall have the right to file an answer to the original or
amended complaint and to appear in person or otherwise and give
testimony at the place and time fixed in the complaint.

    (b)  Additional Parties. In the discretion of the hearing
officer conducting the hearing, any other person may be allowed
to intervene in the proceeding and to present testimony.

    (c)  Hearings.

        (1)  De novo hearing. Each hearing officer shall hear
complaints and motions de novo.

        (2)  Testimony.The testimony taken by the hearing
officer shall be reduced to writing. Thereafter, the hearing
officer, in his or her discretion, upon notice may provide for
the taking of further testimony or hear argument.

        (3)  Authority of hearing officers. The hearing officer
may compel by subpoena the attendance of witnesses and the
production of evidence at any designated place or hearing. In
case of contumacy or refusal to obey a subpoena lawfully issued
under this paragraph and upon application of the hearing
officer, an appropriate district court of the United States may
issue an order requiring compliance with the subpoena and any
failure to
obey the order may be punished by the court as a contempt
thereof. The hearing officer may also seek enforcement of the
subpoena in a State court of competent jurisdiction.
        (4)  Expedited hearings. Notwithstanding section 5203
and the preceding provisions of this section, upon receipt of a
complaint containing a claim described in section 5201(c)(1),
the complaint review office shall promptly provide the
complainant with the opportunity to make an election under
section 5203(a)(3) and assignment to a hearing on the complaint
before a hearing officer. The complaint review office shall
ensure that such a hearing commences not later than 24 hours
after receipt of the complaint by the complaint hearing office.
    (d)  Decision of Hearing Officer.
        (1)  In general. The hearing officer shall decide upon
the preponderance of the evidence whether to decide in favor of
the complainant with respect to each alleged act or practice.
Each such decision
            (A)  shall include the hearing officer's findings
of fact, and
            (B)  shall constitute the hearing officer's final
disposition of the proceedings.
        (2)  Decisions finding in favor of complainant.If the
hearing officer's decision includes a determination that any
party named in the complaint has engaged in or is engaged in an
act or practice described in section 5202(b), the hearing
officer shall issue and cause to be served on such party an
order which requires such party
            (A)  to cease and desist from such act or practice,
            (B)  to provide the benefits due under the terms of
the plan and to otherwise comply with the terms of the plan and
the applicable requirements of this Act,
            (C)  to pay to the complainant prejudgment interest
on the actual costs incurred in obtaining the items and
services at issue in the complaint, and
          (D)  to pay to the prevailing complainant a
reasonable attorney's fee, reasonable expert witness fees, and
other reasonable costs relating to the hearing on the charges
on which the complainant prevails.

      (3)  Decisions not in favor of complainant. If the
hearing officer's decision includes a determination that the
party named in the complaint has not engaged in or is not
engaged in an act or practice referred to in section 5202(b),
the hearing officer

            (A)  shall include in the decision a dismissal of
the charge in the complaint relating to the act or practice,
and

            (B)  upon a finding that such charge is frivolous,
shall issue and cause to be served on the complainant an order
which requires the complainant to pay to such party a
reasonable attorney's fee, reasonable expert witness fees, and
other reasonable costs relating to the proceedings on such
charge.

        (4)  Submission and service of decisions. The hearing
officer shall submit each decision to the complaint review
office
at the conclusion of the proceedings and the office shall cause
a copy of the decision to be served on the parties to the
proceedings.
    (e)  Review.
        (1)  In general. The decision of the hearing officer
shall be final and binding upon all parties. Except as provided
in paragraph (2), any party to the complaint may, within 30
days after service of the decision by the complaint review
office, file an appeal of the decision with the Federal Health
Plan Review Board under section 5205 in such form and manner as
may be prescribed by such Board.
        (2)  Exception. The decision in the case of an
expedited hearing under subsection (c)(4) shall not be subject
to review.
    (f)  Court Enforcement of Orders.
        (1)  In general. If a decision of the hearing officer
in favor of the complainant is not appealed under section 5205,
the complainant may petition any court of competent
jurisdiction for enforcement of the order. In any such
proceeding, the order of the hearing officer shall not be
subject to review.
        (2)  Awarding of costs. In any action for court
enforcement under this subsection, a prevailing complainant
shall be entitled to a reasonable attorney's fee, reasonable
expert witness fees, and other reasonable costs relating to
such action.