Requires a plan to cover additional emergency medical care to stabilize an emergency medical condition following an emergency screening examination.
Requires a plan (other than certain small employer plans) providing benefit coverage only through a defined set of participating health care professionals to offer the option of point-of-service coverage (of the same benefits provided by a nonparticipating health care professional), unless the plan offers multiple coverage options.
Prohibits a plan that covers routine obstetrical, gynecological, or pediatric care from requiring a referral for that care and requires a plan to treat certain referrals by an obstetrician, gynecologist, or pediatrician as a referral by a primary provider.
Requires a plan to ensure that participants and beneficiaries have access to covered specialty care.
Requires a plan to permit a participant or beneficiary undergoing a course of treatment to continue such treatment for a period of time even though the contract between the plan and a health care provider is terminated, or the schedule of benefits or coverage is terminated by a change in the terms of the provider's participation in the plan. Specifies a 90-day continuation of coverage generally, and other transitional periods for institutionalization (until discharge), pregnancy (through postpartum care), and terminal illness.
Directs: (1) the Medicare Payment Advisory Commission to conduct a study of cost, quality, and coordination of coverage for the terminally ill; (2) the Agency for Health Care to conduct studies of the possible thresholds for major conditions causing serious and complex illnesses; and (3) the Health Care Financing Administration to conduct studies of the merits of applying similar thresholds in Medicare + Choice programs. Obligates funds for such studies.
Prohibits a plan from restricting a health care professional from advising a patient about the patient's health status, medical care, or treatment, regardless of whether such care or treatment is covered.
Requires a plan that covers prescription drugs only if included in a formulary to ensure the participation of physicians and pharmacists in developing and reviewing the formulary and to provide for exceptions to the formulary when medically necessary and appropriate.
Prohibits a plan from: (1) discouraging a participant or beneficiary from self-paying for behavioral health services once the plan has denied coverage; or (2) terminating a provider because the provider permits participants or beneficiaries to self-pay for non- covered behavioral services.
Applies most of the above requirements of this Act separately to each coverage option with regard to a plan that has more than one coverage option.
(Sec. 102) Mandates a study and report to a specified Senate committee of patient access to clinical trials and the coverage of routine patient care costs by private health plans and insurers.
Directs the Secretary to provide for necessary funding.
Subtitle B: Right to Information about Plans and Providers - Requires plans and group health insurance issuers to disclose specified plan information to participants, beneficiaries, and (upon request) potential enrollees.
Amends the Internal Revenue Code to require plans to disclose specified plan information to participants, beneficiaries, and (upon request) potential enrollees.
(Sec. 112) Mandates a study and report to appropriate congressional committees on: (1) health care professionals information currently available to patients, consumers, States, and professional societies, nationally and on a State-by-State basis; (2) the legal and other barriers to the sharing of information about health care professionals; and (3) recommendations for disclosure of such information on health care professionals, including their competencies and professional qualifications, to better facilitate patient choice, quality improvement, and market competition.
Subtitle C: Right to Hold Health Plans Accountable - Amends ERISA to revise requirements for denied claim appeal procedures.
Requires a plan or health insurance issuer conducting utilization review to have: (1) specified procedures in place for coverage determinations, including expedited determinations; (2) written procedures for addressing grievances between a plan or issuer and a participant or beneficiary; (3) an internal procedure for coverage determination appeals; and (4) an external review procedure for participant or beneficiary appeals, involving specified entities and independent medical experts, whose determination shall be binding.
Prescribes external review standards.
Directs the General Accounting Office to study and report to the appropriate congressional committees on a statistically appropriate sample of completed external reviews.
Title II: Women's Health and Cancer Rights - Women's Health and Cancer Rights Act of 1999 - Amends the ERISA, as amended by the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999, and the Public Health Service Act, as amended by the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999, to require certain group health plans, and health insurance issuers providing coverage under a group plan, to ensure specified minimum coverage regarding: (1) breast cancer mastectomies, lumpectomies, and lymph node dissections; and (2) secondary consultations by specialists. Prohibits: (1) changing coverage terms and conditions based on a participant's or beneficiary's decision to request less than the minimum coverage; and (2) certain penalties or incentives to providers or specialists. Amends: (1) the Public Health Service Act to apply the same requirements to health insurance issuers in the individual market; and (2) the Internal Revenue Code to apply those requirements to group health plans.
Title III: Genetic Information and Services - Genetic Information Nondiscrimination in Health Insurance Act of 1999 - Amends ERISA and the Public Health Service Act to prohibit a plan or issuer from: (1) basing enrollment eligibility on information about a request for or receipt of genetic services; (2) adjusting premium or contribution amounts for a group based on predictive genetic information concerning any individual, including information about a request for or receipt of genetic services; or (3) except as needed for diagnosis, treatment, or payment, requesting or requiring predictive genetic information concerning any individual. Mandates notice of a plan's or issuer's confidentiality practices regarding predictive genetic information. Requires development and dissemination of model notices. Requires a plan or issuer to maintain safeguards to protect the confidentiality, security, accuracy, and integrity of predictive genetic information.
(Sec. 203) Amends the Public Health Service Act to apply the requirements of this title to issuers offering coverage in the individual market.
(Sec. 204) Amends the Internal Revenue Code to apply the requirements of this title to group health plans.
Title IV: Healthcare Research and Quality - Healthcare Research and Quality Act of 1999 - Amends the Public Health Service Act to establish in the Public Health Service an Agency for Healthcare Research and Quality to replace the current Agency for Health Care Policy and Research.
Authorizes: (1) training grants in health services research including pre- and post-doctoral fellowships and training programs and young investigator awards; and (2) financial assistance to establish and operate centers for multidisciplinary health services research, demonstration projects, evaluations, training, and policy analysis.
Directs the Agency to identify and disseminate methods or systems used to assess health care research results, particularly to rate the strength of the scientific evidence behind health care practice, recommendations in research literature, and technology assessments.
Requires the Agency to employ research strategies and mechanisms that will link research directly with clinical practice in geographically diverse locations throughout the United States, including: (1) Healthcare Improvement Research Centers that combine demonstrated multidisciplinary expertise in outcomes or quality improvement research with linkages to relevant sites of care; (2) Provider-based Research Networks, including plan, facility, or delivery system sites of care (especially primary care), that can evaluate and promote quality improvement; and (3) other innovative mechanisms or strategies.
Authorizes the Agency to provide specified scientific and technical support for private and public efforts to improve health care quality, including activities of accrediting organizations.
Directs the Secretary of Health and Human Services (Secretary), acting through the Agency Director, to establish a demonstration program of grants for one or more centers to conduct: (1) state-of-the-art clinical, laboratory, or health services research on drugs, biological products, and devices; (2) research on the comparative effectiveness, cost-effectiveness, and safety of drugs, biological products, and devices; and (3) other appropriate activities (excluding the review of new drugs).
Mandates conducting and supporting research and building private-public partnerships to: (1) identify the causes of preventable healthcare errors; (2) develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety; and (3) promote implementation of effective strategies.
Requires the Agency Director to: (1) collect certain data on the cost and quality of health care; and (2) support research on and initiatives to advance the use of information systems for the study of health care quality.
Authorizes the Director to periodically convene a Preventive Services Task Force to review scientific evidence related to the effectiveness, appropriateness, and cost-effectiveness of clinical preventive services.
Establishes within the Agency a Center for Primary Care Research to serve as the principal funding source for Department of Health and Human Services primary care research and demonstrations with respect to 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.
Mandates the promotion of innovation in evidence-based clinical practice and health care technologies.
Requires coordination of all research, evaluations, and demonstrations related to health services research and quality measurement and improvement activities undertaken and supported by the Federal Government.
Requires the Institute of Medicine to describe and evaluate current quality improvement research and monitoring processes and recommend improvements.
Establishes an Advisory Council for Healthcare Research and Quality.
Requires that appropriate technical and scientific peer review be conducted regarding each application for a grant, cooperative agreement, or contract under this title and prohibits approving an application unless the peer review so recommended.
Mandates establishment of standard methods for developing and collecting the Agency's data.
Authorizes the Agency, on request of a public or private entity, to conduct or support research or analyses otherwise authorized under this title, with the entity paying service costs.
Authorizes appropriations through FY 2006.
Title V: Enhanced Access to Health Insurance Coverage - Amends the Internal Revenue Code to allow a full deduction from gross income for a self-employed individual's health insurance costs.
(Sec. 502) Repeals the limitation on the availability of medical savings accounts (MSAs) to employees of small employers and the self-employed.
Repeals the limitation on the number of taxpayers having MSAs.
Reduces from $1,500 to $1,000 (self-only coverage) and from $3,000 to $2,000 (family coverage) the minimum annual deductible of a high deductible health plan.
Revises the formula for the monthly limitation on the allowable deduction for MSAs to increase the contribution limit to 100 percent of the annual deductible under a high deductible health plan.
Waives the additional tax on MSA distributions not used for qualified medical expenses to the extent any payment or distribution does not reduce the fair market value of the MSA assets to an amount less than the annual deductible for the account holder's high deductible health plan.
Treats certain network-based managed care plans as high deductible health plans.
(Sec. 503) Authorizes the Office of Personnel Management to contract for catastrophic Federal employees health benefits.
Amends Federal civil service law, with respect to Government contributions under the Federal Employees Health Benefits Program (FEHBP), to require an additional Government contribution, according to a certain formula, to an individual's MSA with respect to a catastrophic plan.
(Sec. 504) Allows the annual carryover of up to $500 of unused benefits from cafeteria plans, flexible spending arrangements, and health flexible spending accounts.
Title VI: Provisions Relating to Long-Term Care Insurance - Amends the Internal Revenue Code to include qualified long-term care insurance contracts as a cafeteria plan qualified benefit.
(Sec. 602) Permits a deduction for eligible long-term health care premiums for an individual who is not eligible for an employer-subsidized long-term care health plan.
(Sec. 603) Directs the Secretary to provide for a study of long-term care needs for the 21st century.
Title VII: Individual Retirement Plans - Amends the Internal Revenue Code to increase to $1 million the adjusted gross income a taxpayer may have and still qualify for a rollover to a Roth IRA.
Title VIII: Revenue Provisions - Amends the Internal Revenue Code to reduce the foreign tax credit carryback by one year, and increase the carryover to seven years.
(Sec. 802) Modifies the permitted use of the special rule permitting accrual method users not to accrue payments for personal services which (on the basis of experience) will not be collected.
(Sec. 803) Requires organizations in the business or trade of lending money to report cancellations of indebtedness income to the Internal Revenue Service (IRS).
(Sec. 804) Directs the Secretary of the Treasury to establish a program of IRS user fees (and exemptions) through September 30, 2009, for ruling, determination, and opinion letters.
(Sec. 805) Provides, with respect to certain transfers of property subject to a liability, that: (1) except as provided by regulations, a recourse liability (or portion thereof) shall be treated as having been assumed if, as determined on the basis of all facts and circumstances, the transferee has agreed to satisfy such liability; and (2) a nonrecourse liability shall, with exceptions, be treated as having been assumed by the transferee of any asset subject to such liability.
(Sec. 806) Disallows any charitable contribution deduction for transfers to or for the use of a charitable remainder trust if in connection with such transfer: (1) the trust directly or indirectly pays, or has previously paid, any personal benefit contract premium with respect to the transferor (split-dollar arrangement); or (2) there is an understanding or expectation that any person will pay such premium. Defines "personal benefit contract." Exempts from treatment as indirect beneficiaries: (1) certain organizations which incur obligations under charitable gift annuity contracts; and (2) persons entitled to payments under certain charitable remainder trusts or unitrusts.
Imposes an excise tax in the amount of any premiums paid in connection with such transfers.
(Sec. 807) Extends through FY 2009 specified treatment of qualified transfers of excess pension assets to retiree health accounts. Prescribes minimum employer cost requirements for plans transferring assets during the first five-year cost maintenance period following a qualified transfer.
(Sec. 808) Revises the exemption from specified tax treatment of welfare benefit funds (prefunding limits) of any welfare benefit fund which is part of a ten or more employer plan. Limits such exemption to funds whose only benefits are medical, disability, or group term life insurance benefits which do not provide for any cash surrender value or other money that can be paid, assigned, borrowed, or pledged as loan collateral.
Revises the meaning of a disqualified benefit which would trigger a certain tax on a welfare benefit fund to set forth a special rule for a ten or more employer plan exempted from prefunding limits. Treats as a disqualified benefit subject to such tax any portio9n of a welfare benefit fund under a ten or more employer plan which is attributable to prefunding limit-exempted contributions if such portion is used for a purpose other than that for which the contributions were made.
(Sec. 809) Prohibits accrual method taxpayers from using the installment method of accounting for installment sales. Revises the special nondealer rules for pledges of installment obligations to declare that an installment payment shall be treated as directly secured by an installment obligation interest to the extent an arrangement allows the taxpayer to satisfy all or a portion of such indebtedness.
(Sec. 810) Imposes a tax on any conjugate vaccine against streptococcus pneumoniae sold by its manufacturer, producer, or importer.
Title IX: Miscellaneous Provisions - Prohibits the Secretary from implementing the Medicare Competitive Pricing Demonstration Project under the Balanced Budget Act of 1997 in: (1) Kansas City, Missouri, or Kansas City, Kansas, or in Arizona; or (2) any area before January 1, 2001.
Directs the Secretary to study and report to Congress on the different approaches of implementing such project on a voluntary basis.
[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 1344 Placed on Calendar Senate (PCS)]
Calendar No. 200
106th CONGRESS
1st Session
S. 1344
_______________________________________________________________________
A BILL
To amend the Public Health Service Act, the Employee Retirement Income
Security Act of 1974, and the Internal Revenue Code of 1986 to protect
consumers in managed care plans and other health coverage.
_______________________________________________________________________
July 8, 1999
Read twice and placed on the calendar
Calendar No. 200
106th CONGRESS
1st Session
S. 1344
To amend the Public Health Service Act, the Employee Retirement Income
Security Act of 1974, and the Internal Revenue Code of 1986 to protect
consumers in managed care plans and other health coverage.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 8, 1999
Mr. Lott (for himself and Mr. Nickles) introduced the following bill;
which was read twice and placed on the calendar, pursuant to the order
of June 29, 1999.
_______________________________________________________________________
A BILL
To amend the Public Health Service Act, the Employee Retirement Income
Security Act of 1974, and the Internal Revenue Code of 1986 to protect
consumers in managed care plans and other health coverage.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Patients' Bill of
Rights Act of 1999''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--HEALTH INSURANCE BILL OF RIGHTS
Subtitle A--Access to Care
Sec. 101. Access to emergency care.
Sec. 102. Offering of choice of coverage options under group health
plans.
Sec. 103. Choice of providers.
Sec. 104. Access to specialty care.
Sec. 105. Continuity of care.
Sec. 106. Coverage for individuals participating in approved clinical
trials.
Sec. 107. Access to needed prescription drugs.
Sec. 108. Adequacy of provider network.
Sec. 109. Nondiscrimination in delivery of services.
Subtitle B--Quality Assurance
Sec. 111. Internal quality assurance program.
Sec. 112. Collection of standardized data.
Sec. 113. Process for selection of providers.
Sec. 114. Drug utilization program.
Sec. 115. Standards for utilization review activities.
Sec. 116. Health Care Quality Advisory Board.
Subtitle C--Patient Information
Sec. 121. Patient information.
Sec. 122. Protection of patient confidentiality.
Sec. 123. Health insurance ombudsmen.
Subtitle D--Grievance and Appeals Procedures
Sec. 131. Establishment of grievance process.
Sec. 132. Internal appeals of adverse determinations.
Sec. 133. External appeals of adverse determinations.
Subtitle E--Protecting the Doctor-Patient Relationship
Sec. 141. Prohibition of interference with certain medical
communications.
Sec. 142. Prohibition against transfer of indemnification or improper
incentive arrangements.
Sec. 143. Additional rules regarding participation of health care
professionals.
Sec. 144. Protection for patient advocacy.
Subtitle F--Promoting Good Medical Practice
Sec. 151. Promoting good medical practice.
Sec. 152. Standards relating to benefits for certain breast cancer
treatment.
Subtitle G--Definitions
Sec. 191. Definitions.
Sec. 192. Preemption; State flexibility; construction.
Sec. 193. Regulations.
TITLE II--APPLICATION OF PATIENT PROTECTION STANDARDS TO GROUP HEALTH
PLANS AND HEALTH INSURANCE COVERAGE UNDER PUBLIC HEALTH SERVICE ACT
Sec. 201. Application to group health plans and group health insurance
coverage.
Sec. 202. Application to individual health insurance coverage.
TITLE III--AMENDMENTS TO THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF
1974
Sec. 301. Application of patient protection standards to group health
plans and group health insurance coverage
under the Employee Retirement Income
Security Act of 1974.
Sec. 302. ERISA preemption not to apply to certain actions involving
health insurance policyholders.
TITLE IV--APPLICATION TO GROUP HEALTH PLANS UNDER THE INTERNAL REVENUE
CODE OF 1986
Sec. 401. Amendments to the Internal Revenue Code of 1986.
TITLE V--EFFECTIVE DATES; COORDINATION IN IMPLEMENTATION
Sec. 501. Effective dates and related rules.
Sec. 502. Coordination in implementation.
TITLE I--HEALTH INSURANCE BILL OF RIGHTS
Subtitle A--Access to Care
SEC. 101. ACCESS TO EMERGENCY CARE.
(a) Coverage of Emergency Services.--
(1) In general.--If a group health plan, or health
insurance coverage offered by a health insurance issuer,
provides any benefits with respect to emergency services (as
defined in paragraph (2)(B)), the plan or issuer shall cover
emergency services furnished under the plan or coverage--
(A) without the need for any prior authorization
determination;
(B) whether or not the health care provider
furnishing such services is a participating provider
with respect to such services;
(C) in a manner so that, if such services are
provided to a participant, beneficiary, or enrollee by
a nonparticipating health care provider without prior
authorization by the plan or issuer, the participant,
beneficiary, or enrollee is not liable for amounts that
exceed the amounts of liability that would be incurred
if the services were provided by a participating health
care provider with prior authorization by the plan or
issuer; and
(D) without regard to any other term or condition
of such coverage (other than exclusion or coordination
of benefits, or an affiliation or waiting period,
permitted under section 2701 of the Public Health
Service Act, section 701 of the Employee Retirement
Income Security Act of 1974, or section 9801 of the
Internal Revenue Code of 1986, and other than
applicable cost-sharing).
(2) Definitions.--In this section:
(A) Emergency medical condition based on prudent
layperson standard.--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 condition
described in clause (i), (ii), or (iii) of section
1867(e)(1)(A) of the Social Security Act.
(B) Emergency services.--The term ``emergency
services'' means--
(i) a medical screening examination (as
required under section 1867 of the Social
Security Act) that is within the capability of
the emergency department of a hospital,
including ancillary services routinely
available to the emergency department to
evaluate an emergency medical condition (as
defined in subparagraph (A)), and
(ii) within the capabilities of the staff
and facilities available at the hospital, such
further medical examination and treatment as
are required under section 1867 of such Act to stabilize the patient.
(b) Reimbursement for Maintenance Care and Post-Stabilization
Care.--In the case of services (other than emergency services) for
which benefits are available under a group health plan, or under health
insurance coverage offered by a health insurance issuer, the plan or
issuer shall provide for reimbursement with respect to such services
provided to a participant, beneficiary, or enrollee other than through
a participating health care provider in a manner consistent with
subsection (a)(1)(C) (and shall otherwise comply with the guidelines
established under section 1852(d)(2) of the Social Security Act
(relating to promoting efficient and timely coordination of appropriate
maintenance and post-stabilization care of an enrollee after an
enrollee has been determined to be stable), or, in the absence of
guidelines under such section, such guidelines as the Secretary shall
establish to carry out this subsection), if the services are
maintenance care or post-stabilization care covered under such
guidelines.
SEC. 102. OFFERING OF CHOICE OF COVERAGE OPTIONS UNDER GROUP HEALTH
PLANS.
(a) Requirement.--
(1) Offering of point-of-service coverage option.--Except
as provided in paragraph (2), if a group health plan (or health
insurance coverage offered by a health insurance issuer in
connection with a group health plan) provides benefits only
through participating health care providers, the plan or issuer
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 or coverage and at such other
times as the plan or issuer offers the participant a choice of
coverage options.
(2) Exception.--Paragraph (1) shall not apply with respect
to a participant in a group health plan if the plan offers the
participant--
(A) a choice of health insurance coverage; and
(B) one or more coverage options that do not
provide benefits only through participating health care
providers.
(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 or health insurance issuer, coverage of such
benefits when provided by a nonparticipating health care provider. Such
coverage need not include coverage of providers that the plan or issuer
excludes because of fraud, quality, or similar reasons.
(c) Construction.--Nothing in this section shall be construed--
(1) as requiring coverage for benefits for a particular
type of health care provider;
(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; or
(3) as preventing a group health plan or health insurance
issuer from imposing higher premiums or cost-sharing on a
participant for the exercise of a point-of-service coverage
option.
(d) No Requirement for Guaranteed Availability.--If a health
insurance issuer offers health insurance coverage that includes point-
of-service coverage with respect to an employer solely in order to meet
the requirement of subsection (a), nothing in section 2711(a)(1)(A) of
the Public Health Service Act shall be construed as requiring the
offering of such coverage with respect to another employer.
SEC. 103. CHOICE OF PROVIDERS.
(a) Primary Care.--A group health plan, and a health insurance
issuer that offers health insurance coverage, shall permit each
participant, beneficiary, and enrollee to receive primary care from any
participating primary care provider who is available to accept such
individual.
(b) Specialists.--
(1) In general.--Subject to paragraph (2), a group health
plan and a health insurance issuer that offers health insurance
coverage shall permit each participant, beneficiary, or
enrollee to receive medically necessary or appropriate
specialty care, pursuant to appropriate referral procedures,
from any qualified participating health care provider who is
available to accept such individual for such care.
(2) Limitation.--Paragraph (1) shall not apply to specialty
care if the plan or issuer clearly informs participants,
beneficiaries, and enrollees of the limitations on choice of
participating providers with respect to such care.
SEC. 104. ACCESS TO SPECIALTY CARE.
(a) Obstetrical and Gynecological Care.--
(1) In general.--If a group health plan, or a health
insurance issuer in connection with the provision of health
insurance coverage, requires or provides for a participant,
beneficiary, or enrollee to designate a participating primary
care provider--
(A) the plan or issuer shall permit such an
individual who is a female to designate a participating
physician who specializes in obstetrics and gynecology
as the individual's primary care provider; and
(B) if such an individual has not designated such a
provider as a primary care provider, the plan or
issuer--
(i) may not require authorization or a
referral by the individual's primary care
provider or otherwise for coverage of routine
gynecological care (such as preventive women's
health examinations) and pregnancy-related
services provided by a participating health
care professional who specializes in obstetrics
and gynecology to the extent such care is
otherwise covered, and
(ii) may treat the ordering of other
gynecological care by such a participating
health professional as the authorization of the
primary care provider with respect to such care
under the plan or coverage.
(2) Construction.--Nothing in paragraph (1)(B)(ii) shall
waive any requirements of coverage relating to medical
necessity or appropriateness with respect to coverage of
gynecological care so ordered.
(b) Specialty Care.--
(1) Specialty care for covered services.--
(A) In general.--If--
(i) an individual is a participant or
beneficiary under a group health plan or an
enrollee who is covered under health insurance
coverage offered by a health insurance issuer,
(ii) the individual has a condition or
disease of sufficient seriousness and
complexity to require treatment by a
specialist, and
(iii) benefits for such treatment are
provided under the plan or coverage,
the plan or issuer shall make or provide for a referral
to a specialist who is available and accessible to
provide the treatment for such condition or disease.
(B) Specialist defined.--For purposes of this
subsection, the term ``specialist'' means, with respect
to a condition, a health care practitioner, facility,
or center (such as a center of excellence) that has
adequate expertise through appropriate training and
experience (including, in the case of a child,
appropriate pediatric expertise) to provide high
quality care in treating the condition.
(C) Care under referral.--A group health plan or
health insurance issuer may require that the care
provided to an individual pursuant to such referral
under subparagraph (A) be--
(i) pursuant to a treatment plan, only if
the treatment plan is developed by the
specialist and approved by the plan or issuer,
in consultation with the designated primary
care provider or specialist and the individual
(or the individual's designee), and
(ii) in accordance with applicable quality
assurance and utilization review standards of
the plan or issuer.
Nothing in this subsection shall be construed as
preventing such a treatment plan for an individual from
requiring a specialist to provide the primary care
provider with regular updates on the specialty care
provided, as well as all necessary medical information.
(D) Referrals to participating providers.--A group
health plan or health insurance issuer is not required
under subparagraph (A) to provide for a referral to a
specialist that is not a participating provider, unless
the plan or issuer does not have an appropriate
specialist that is available and accessible to treat
the individual's condition and that is a participating
provider with respect to such treatment.
(E) Treatment of nonparticipating providers.--If a
plan or issuer refers an individual to a
nonparticipating specialist pursuant to subparagraph
(A), services provided pursuant to the approved
treatment plan (if any) shall be provided at no
additional cost to the individual beyond what the
individual would otherwise pay for services received by
such a specialist that is a participating provider.
(2) Specialists as primary care providers.--
(A) In general.--A group health plan, or a health
insurance issuer, in connection with the provision of
health insurance coverage, shall have a procedure by
which an individual who is a participant, beneficiary,
or enrollee and who has an ongoing special condition
(as defined in subparagraph (C)) may receive a referral
to a specialist for such condition who shall be
responsible for and capable of providing and
coordinating the individual's primary and specialty
care. If such an individual's care would most
appropriately be coordinated by such a specialist, such
plan or issuer shall refer the individual to such
specialist.
(B) Treatment as primary care provider.--Such
specialist shall be permitted to treat the individual
without a referral from the individual's primary care
provider and may authorize such referrals, procedures,
tests, and other medical services as the individual's
primary care provider would otherwise be permitted to
provide or authorize, subject to the terms of the
treatment plan (referred to in paragraph (1)(C)(i)).
(C) Ongoing special condition defined.--In this
paragraph, the term ``special condition'' means a
condition or disease that--
(i) is life-threatening, degenerative, or
disabling, and
(ii) requires specialized medical care over
a prolonged period of time.
(D) Terms of referral.--The provisions of
subparagraphs (C) through (E) of paragraph (1) apply
with respect to referrals under subparagraph (A) of
this paragraph in the same manner as they apply to
referrals under paragraph (1)(A).
(3) Standing referrals.--
(A) In general.--A group health plan, and a health
insurance issuer in connection with the provision of
health insurance coverage, shall have a procedure by
which an individual who is a participant, beneficiary,
or enrollee and who has a condition that requires
ongoing care from a specialist may receive a standing
referral to such specialist for treatment of such condition. If the
plan or issuer, or if the primary care provider in consultation with
the medical director of the plan or issuer and the specialist (if any),
determines that such a standing referral is appropriate, the plan or
issuer shall make such a referral to such a specialist.
(B) Terms of referral.--The provisions of
subparagraphs (C) through (E) of paragraph (1) apply
with respect to referrals under subparagraph (A) of
this paragraph in the same manner as they apply to
referrals under paragraph (1)(A).
SEC. 105. CONTINUITY OF CARE.
(a) In General.--
(1) Termination of provider.--If a contract between a group
health plan, or a health insurance issuer in connection with
the provision of health insurance coverage, and a health care
provider is terminated (as defined in paragraph (3)), or
benefits or coverage provided by a health care provider are
terminated because of a change in the terms of provider
participation in a group health plan, and an individual who is
a participant, beneficiary, or enrollee in the plan or coverage
is undergoing a course of treatment from the provider at the
time of such termination, the plan or issuer shall--
(A) notify the individual on a timely basis of such
termination, and
(B) subject to subsection (c), permit the
individual to continue or be covered with respect to
the course of treatment with the provider during a
transitional period (provided under subsection (b)).
(2) Treatment of termination of contract with health
insurance issuer.--If a contract for the provision of health
insurance coverage between a group health plan and a health
insurance issuer is terminated and, as a result of such
termination, coverage of services of a health care provider is
terminated with respect to an individual, the provisions of
paragraph (1) (and the succeeding provisions of this section)
shall apply under the plan in the same manner as if there had
been a contract between the plan and the provider that had been
terminated, but only with respect to benefits that are covered
under the plan after the contract termination.
(3) Termination.--In this section, the term ``terminated''
includes, with respect to a contract, the expiration or
nonrenewal of the contract, but does not include a termination
of the contract by the plan or issuer for failure to meet
applicable quality standards or for fraud.
(b) Transitional Period.--
(1) In general.--Except as provided in paragraphs (2)
through (4), the transitional period under this subsection
shall extend for at least 90 days from the date of the notice
described in subsection (a)(1)(A) of the provider's
termination.
(2) Institutional care.--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.--If--
(A) a participant, beneficiary, or enrollee 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
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.--If--
(A) a participant, beneficiary, or enrollee was
determined to be terminally ill (as determined under
section 1861(dd)(3)(A) of the Social Security Act) at
the time of a provider's termination of participation,
and
(B) the provider was treating the terminal illness
before the date of termination,
the transitional period under this subsection shall extend for
the remainder of the individual's life for care directly
related to the treatment of the terminal illness.
(c) Permissible Terms and Conditions.--A group health plan or
health insurance issuer 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 or issuer 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 (a)(2), at the rates applicable under
the replacement plan or issuer after the date of the
termination of the contract with the health insurance issuer)
and not to impose cost-sharing with respect to the individual
in an amount that would exceed the cost-sharing that could have
been imposed if the contract referred to in subsection (a)(1)
had not been terminated.
(2) The provider agrees to adhere to the quality assurance
standards of the plan or issuer responsible for payment under
paragraph (1) and to provide to such plan or issuer necessary
medical information related to the care provided.
(3) The provider agrees otherwise to adhere to such plan's
or issuer'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 or issuer.
(d) 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.
SEC. 106. COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL
TRIALS.
(a) Coverage.--
(1) In general.--If a group health plan, or health
insurance issuer that is providing health insurance coverage,
provides coverage to a qualified individual (as defined in
subsection (b)), the plan or issuer--
(A) may not deny the individual participation in
the clinical trial referred to in subsection (b)(2);
(B) subject to subsection (c), may not deny (or
limit or impose additional conditions on) the coverage
of routine patient costs for items and services
furnished in connection with participation in the
trial; and
(C) may not discriminate against the individual on
the basis of the enrollee's participation in such
trial.
(2) Exclusion of certain costs.--For purposes of paragraph
(1)(B), routine patient costs do not include the cost of the
tests or measurements conducted primarily for the purpose of
the clinical trial involved.
(3) Use of in-network providers.--If one or more
participating providers is participating in a clinical trial,
nothing in paragraph (1) shall be construed as preventing a
plan or issuer from requiring that a qualified individual
participate in the trial through such a participating provider
if the provider will accept the individual as a participant in
the trial.
(b) Qualified Individual Defined.--For purposes of subsection (a),
the term ``qualified individual'' means an individual who is a
participant or beneficiary in a group health plan, or who is an
enrollee under health insurance coverage, and who meets the following
conditions:
(1)(A) The individual has a life-threatening or serious
illness for which no standard treatment is effective.
(B) The individual is eligible to participate in an
approved clinical trial according to the trial protocol with
respect to treatment of such illness.
(C) The individual's participation in the trial offers
meaningful potential for significant clinical benefit for the
individual.
(2) Either--
(A) the referring physician is a participating
health care professional and has concluded that the
individual's participation in such trial would be
appropriate based upon the individual meeting the
conditions described in paragraph (1); or
(B) the participant, beneficiary, or enrollee
provides medical and scientific information
establishing that the individual's participation in
such trial would be appropriate based upon the
individual meeting the conditions described in
paragraph (1).
(c) Payment.--
(1) In general.--Under this section a group health plan or
health insurance issuer shall provide for payment for routine
patient costs described in subsection (a)(2) but is not
required to pay for costs of items and services that are
reasonably expected (as determined by the Secretary) to be paid
for by the sponsors of an approved clinical trial.
(2) Payment rate.--In the case of covered items and
services provided by--
(A) a participating provider, the payment rate
shall be at the agreed upon rate, or
(B) a nonparticipating provider, the payment rate
shall be at the rate the plan or issuer would normally
pay for comparable services under subparagraph (A).
(d) Approved Clinical Trial Defined.--
(1) In general.--In this section, the term ``approved
clinical trial'' means a clinical research study or clinical
investigation approved and funded (which may include funding
through in-kind contributions) by one or more of the following:
(A) The National Institutes of Health.
(B) A cooperative group or center of the National
Institutes of Health.
(C) Either of the following if the conditions
described in paragraph (2) are met:
(i) The Department of Veterans Affairs.
(ii) The Department of Defense.
(2) Conditions for departments.--The conditions described
in this paragraph, for a study or investigation conducted by a
Department, are that the study or investigation has been
reviewed and approved through a system of peer review that the
Secretary determines--
(A) to be comparable to the system of peer review
of studies and investigations used by the National
Institutes of Health, and
(B) assures unbiased review of the highest
scientific standards by qualified individuals who have
no interest in the outcome of the review.
(e) Construction.--Nothing in this section shall be construed to
limit a plan's or issuer's coverage with respect to clinical trials.
SEC. 107. ACCESS TO NEEDED PRESCRIPTION DRUGS.
(a) In General.--If a group health plan, or health insurance issuer
that offers health insurance coverage, provides benefits with respect
to prescription drugs but the coverage limits such benefits to drugs
included in a formulary, the plan or issuer shall--
(1) ensure participation of participating physicians and
pharmacists in the development of the formulary;
(2) disclose to providers and, disclose upon request under
section 121(c)(6) to participants, beneficiaries, and
enrollees, the nature of the formulary restrictions; and
(3) consistent with the standards for a utilization review
program under section 115, provide for exceptions from the
formulary limitation when a non-formulary alternative is
medically indicated.
(b) Coverage of Approved Drugs and Medical Devices.--
(1) In general.--A group health plan (or health insurance
coverage offered in connection with such a plan) that provides
any coverage of prescription drugs or medical devices shall not
deny coverage of such a drug or device on the basis that the
use is investigational, if the use--
(A) in the case of a prescription drug--
(i) is included in the labeling authorized
by the application in effect for the drug
pursuant to subsection (b) or (j) of section
505 of the Federal Food, Drug, and Cosmetic
Act, without regard to any postmarketing
requirements that may apply under such Act; or
(ii) is included in the labeling authorized
by the application in effect for the drug under
section 351 of the Public Health Service Act,
without regard to any postmarketing
requirements that may apply pursuant to such
section; or
(B) in the case of a medical device, is included in
the labeling authorized by a regulation under
subsection (d) or (3) of section 513 of the Federal
Food, Drug, and Cosmetic Act, an order under subsection
(f) of such section, or an application approved under
section 515 of such Act, without regard to any
postmarketing requirements that may apply under such
Act.
(2) Construction.--Nothing in this subsection shall be
construed as requiring a group health plan (or health insurance
coverage offered in connection with such a plan) to provide any
coverage of prescription drugs or medical devices.
SEC. 108. ADEQUACY OF PROVIDER NETWORK.
(a) In General.--Each group health plan, and each health insurance
issuer offering health insurance coverage, that provides benefits, in
whole or in part, through participating health care providers shall
have (in relation to the coverage) a sufficient number, distribution,
and variety of qualified participating health care providers to ensure
that all covered health care services, including specialty services,
will be available and accessible in a timely manner to all
participants, beneficiaries, and enrollees under the plan or coverage.
This subsection shall only apply to a plan's or issuer's application of
restrictions on the participation of health care providers in a network
and shall not be construed as requiring a plan or issuer to create or
establish new health care providers in an area.
(b) Treatment of Certain Providers.--The qualified health care
providers under subsection (a) may include Federally qualified health
centers, rural health clinics, migrant health centers, and other
essential community providers located in the service area of the plan
or issuer and shall include such providers if necessary to meet the
standards established to carry out such subsection.
SEC. 109. NONDISCRIMINATION IN DELIVERY OF SERVICES.
(a) Application to Delivery of Services.--Subject to subsection
(b), a group health plan, and health insurance issuer in relation to
health insurance coverage, may not discriminate against a participant,
beneficiary, or enrollee in the delivery of health care services
consistent with the benefits covered under the plan or coverage or as
required by law based on race, color, ethnicity, national origin,
religion, sex, age, mental or physical disability, sexual orientation,
genetic information, or source of payment.
(b) Construction.--Nothing in subsection (a) shall be construed as
relating to the eligibility to be covered, or the offering (or
guaranteeing the offer) of coverage, under a plan or health insurance
coverage, the application of any pre-existing condition exclusion
consistent with applicable law, or premiums charged under such plan or
coverage. Pursuant to section 192(b), except as provided in section
152, nothing in this title shall be construed as requiring a group
health plan or health insurance issuer to provide specific benefits
under the terms of such plan or coverage.
Subtitle B--Quality Assurance
SEC. 111. INTERNAL QUALITY ASSURANCE PROGRAM.
(a) Requirement.--A group health plan, and a health insurance
issuer that offers health insurance coverage, shall establish and
maintain an ongoing, internal quality assurance and continuous quality
improvement program that meets the requirements of subsection (b).
(b) Program Requirements.--The requirements of this subsection for
a quality improvement program of a plan or issuer are as follows:
(1) Administration.--The plan or issuer has a separate
identifiable unit with responsibility for administration of the
program.
(2) Written plan.--The plan or issuer has a written plan
for the program that is updated annually and that specifies at
least the following:
(A) The activities to be conducted.
(B) The organizational structure.
(C) The duties of the medical director.
(D) Criteria and procedures for the assessment of
quality.
(3) Systematic review.--The program provides for systematic
review of the type of health services provided, consistency of
services provided with good medical practice, and patient
outcomes.
(4) Quality criteria.--The program--
(A) uses criteria that are based on performance and
patient outcomes where feasible and appropriate;
(B) includes criteria that are directed
specifically at meeting the needs of at-risk
populations and covered individuals with chronic
conditions or severe illnesses, including gender-
specific criteria and pediatric-specific criteria where
available and appropriate;
(C) includes methods for informing covered
individuals of the benefit of preventive care and what
specific benefits with respect to preventive care are
covered under the plan or coverage; and
(D) makes available to the public a description of
the criteria used under subparagraph (A).
(5) System for reporting.--The program has procedures for
reporting of possible quality concerns by providers and
enrollees and for remedial actions to correct quality problems,
including written procedures for responding to concerns and
taking appropriate corrective action.
(6) Data analysis.--The program provides, using data that
include the data collected under section 112, for an analysis
of the plan's or issuer's performance on quality measures.
(7) Drug utilization review.--The program provides for a
drug utilization review program in accordance with section 114.
(c) Deeming.--For purposes of subsection (a), the requirements of--
(1) subsection (b) (other than paragraph (5)) are deemed to
be met with respect to a health insurance issuer that is a
qualified health maintenance organization (as defined in
section 1310(c) of the Public Health Service Act); or
(2) subsection (b) are deemed to be met with respect to a
health insurance issuer that is accredited by a national
accreditation organization that the Secretary certifies as
applying, as a condition of certification, standards at least a
stringent as those required for a quality improvement program
under subsection (b).
(d) Variation Permitted.--The Secretary may provide for variations
in the application of the requirements of this section to group health
plans and health insurance issuers based upon differences in the
delivery system among such plans and issuers as the Secretary deems
appropriate.
SEC. 112. COLLECTION OF STANDARDIZED DATA.
(a) In General.--A group health plan and a health insurance issuer
that offers health insurance coverage shall collect uniform quality
data that include a minimum uniform data set described in subsection
(b).
(b) Minimum Uniform Data Set.--The Secretary shall specify (and may
from time to time update) the data required to be included in the
minimum uniform data set under subsection (a) and the standard format
for such data. Such data shall include at least--
(1) aggregate utilization data;
(2) data on the demographic characteristics of
participants, beneficiaries, and enrollees;
(3) data on disease-specific and age-specific mortality
rates and (to the extent feasible) morbidity rates of such
individuals;
(4) data on satisfaction (including satisfaction with
respect to services to children) of such individuals, including
data on voluntary disenrollment and grievances; and
(5) data on quality indicators and health outcomes,
including, to the extent feasible and appropriate, data on
pediatric cases and on a gender-specific basis.
(c) Availability.--A summary of the data collected under subsection
(a) shall be disclosed under section 121(b)(9). The Secretary shall be
provided access to all the data so collected.
(d) Variation Permitted.--The Secretary may provide for variations
in the application of the requirements of this section to group health
plans and health insurance issuers based upon differences in the
delivery system among such plans and issuers as the Secretary deems
appropriate.
(e) Exception for Non-Medical, Religious Care Providers.--The
requirements of subsection (a), insofar as they may apply to a provider
of health care, do not apply to a provider that provides no medical
care and that provides only a religious method of healing or religious
nonmedical nursing care.
SEC. 113. PROCESS FOR SELECTION OF PROVIDERS.
(a) In General.--A group health plan and a health insurance issuer
that offers health insurance coverage shall, if it provides benefits
through participating health care professionals, have a written process
for the selection of participating health care professionals, including
minimum professional requirements.
(b) Verification of Background.--Such process shall include
verification of a health care provider's license and a history of
suspension or revocation.
(c) Restriction.--Such process shall not use a high-risk patient
base or location of a provider in an area with residents with poorer
health status as a basis for excluding providers from participation.
(d) Nondiscrimination Based on Licensure.--
(1) In general.--Such process shall not discriminate with
respect to participation or indemnification as to any provider
who is acting within the scope of the provider's license or
certification under applicable State law, solely on the basis
of such license or certification.
(2) Construction.--Paragraph (1) shall not be construed--
(A) as requiring the coverage under a plan or
coverage of particular benefits or services or to
prohibit a plan or issuer from including providers only
to the extent necessary to meet the needs of the plan's
or issuer's participants, beneficiaries, or enrollees
or from establishing any measure designed to maintain
quality and control costs consistent with the
responsibilities of the plan or issuer; or
(B) to override any State licensure or scope-of-
practice law.
(e) General Nondiscrimination.--
(1) In general.--Subject to paragraph (2), such process
shall not discriminate with respect to selection of a health
care professional to be a participating health care provider,
or with respect to the terms and conditions of such
participation, based on the professional's race, color,
religion, sex, national origin, age, sexual orientation, or
disability (consistent with the Americans with Disabilities Act
of 1990).
(2) Rules.--The appropriate Secretary may establish such
definitions, rules, and exceptions as may be appropriate to
carry out paragraph (1), taking into account comparable
definitions, rules, and exceptions in effect under employment-
based nondiscrimination laws and regulations that relate to
each of the particular bases for discrimination described in
such paragraph.
SEC. 114. DRUG UTILIZATION PROGRAM.
A group health plan, and a health insurance issuer that provides
health insurance coverage, that includes benefits for prescription
drugs shall establish and maintain, as part of its internal quality
assurance and continuous quality improvement program under section 111,
a drug utilization program which--
(1) encourages appropriate use of prescription drugs by
participants, beneficiaries, and enrollees and providers, and
(2) takes appropriate action to reduce the incidence of
improper drug use and adverse drug reactions and interactions.
SEC. 115. STANDARDS FOR UTILIZATION REVIEW ACTIVITIES.
(a) Compliance with Requirements.--
(1) In general.--A group health plan, and a health
insurance issuer that provides health insurance coverage, shall
conduct utilization review activities in connection with the
provision of benefits under such plan or coverage only in
accordance with a utilization review program that meets the
requirements of this section.
(2) Use of outside agents.--Nothing in this section shall
be construed as preventing a group health plan or health
insurance issuer from arranging through a contract or otherwise
for persons or entities to conduct utilization review
activities on behalf of the plan or issuer, so long as such
activities are conducted in accordance with a utilization
review program that meets the requirements of this section.
(3) Utilization review defined.--For purposes of this
section, the terms ``utilization review'' and ``utilization
review activities'' mean procedures used to monitor or evaluate
the clinical necessity, appropriateness, efficacy, or
efficiency of health care services, procedures or settings, and
includes prospective review, concurrent review, second
opinions, case management, discharge planning, or retrospective
review.
(b) Written Policies and Criteria.--
(1) Written policies.--A utilization review program shall
be conducted consistent with written policies and procedures
that govern all aspects of the program.
(2) Use of written criteria.--
(A) In general.--Such a program shall utilize
written clinical review criteria developed pursuant to
the program with the input of appropriate physicians.
Such criteria shall include written clinical review
criteria described in section 111(b)(4)(B).
(B) Continuing use of standards in retrospective
review.--If a health care service has been specifically
pre-authorized or approved for an enrollee under such a
program, the program shall not, pursuant to
retrospective review, revise or modify the specific
standards, criteria, or procedures used for the
utilization review for procedures, treatment, and
services delivered to the enrollee during the same
course of treatment.
(c) Conduct of Program Activities.--
(1) Administration by health care professionals.--A
utilization review program shall be administered by qualified
health care professionals who shall oversee review decisions.
In this subsection, the term ``health care professional'' means
a physician or other health care practitioner licensed,
accredited, or certified to perform specified health services
consistent with State law.
(2) Use of qualified, independent personnel.--
(A) In general.--A utilization review program shall
provide for the conduct of utilization review
activities only through personnel who are qualified
and, to the extent required, who have received
appropriate training in the conduct of such activities
under the program.
(B) Peer review of sample of adverse clinical
determinations.--Such a program shall provide that
clinical peers (as defined in section 191(c)(2)) shall
evaluate the clinical appropriateness of at least a
sample of adverse clinical determinations.
(C) Prohibition of contingent compensation
arrangements.--Such a program shall not, with respect
to utilization review activities, permit or provide
compensation or anything of value to its employees,
agents, or contractors in a manner that--
(i) provides incentives, direct or
indirect, for such persons to make
inappropriate review decisions, or
(ii) is based, directly or indirectly, on
the quantity or type of adverse determinations
rendered.
(D) Prohibition of conflicts.--Such a program shall
not permit a health care professional who provides
health care services to an individual to perform
utilization review activities in connection with the
health care services being provided to the individual.
(3) Accessibility of review.--Such a program shall provide
that appropriate personnel performing utilization review
activities under the program are reasonably accessible by toll-
free telephone during normal business hours to discuss patient
care and allow response to telephone requests, and that
appropriate provision is made to receive and respond promptly
to calls received during other hours.
(4) Limits on frequency.--Such a program shall not provide
for the performance of utilization review activities with
respect to a class of services furnished to an individual more
frequently than is reasonably required to assess whether the
services under review are medically necessary or appropriate.
(5) Limitation on information requests.--Under such a
program, information shall be required to be provided by health
care providers only to the extent it is necessary to perform
the utilization review activity involved.
(d) Deadline for Determinations.--
(1) Prior authorization services.--Except as provided in
paragraph (2), in the case of a utilization review activity
involving the prior authorization of health care items and
services for an individual, the utilization review program
shall make a determination concerning such authorization, and
provide notice of the determination to the individual or the
individual's designee and the individual's health care provider
by telephone and in printed form, as soon as possible in
accordance with the medical exigencies of the cases, and in no
event later than 3 business days after the date of receipt of
information that is reasonably necessary to make such
determination.
(2) Continued care.--In the case of a utilization review
activity involving authorization for continued or extended
health care services for an individual, or additional services
for an individual undergoing a course of continued treatment
prescribed by a health care provider, the utilization review
program shall make a determination concerning such
authorization, and provide notice of the determination to the
individual or the individual's designee and the individual's
health care provider by telephone and in printed form, as soon
as possible in accordance with the medical exigencies of the
cases, and in no event later than 1 business day after the date
of receipt of information that is reasonably necessary to make
such determination. Such notice shall include, with respect to
continued or extended health care services, the number of
extended services approved, the new total of approved services,
the date of onset of services, and the next review date, if
any.
(3) Previously provided services.--In the case of a
utilization review activity involving retrospective review of
health care services previously provided for an individual, the
utilization review program shall make a determination
concerning such services, and provide notice of the
determination to the individual or the individual's designee
and the individual's health care provider by telephone and in
printed form, within 30 days of the date of receipt of
information that is reasonably necessary to make such
determination.
(4) Reference to special rules for emergency services,
maintenance care, and post-stabilization care.--For waiver of
prior authorization requirements in certain cases involving
emergency services and maintenance care and post-stabilization
care, see subsections (a)(1) and (b) of section 101,
respectively.
(e) Notice of Adverse Determinations.--
(1) In general.--Notice of an adverse determination under a
utilization review program shall be provided in printed form
and shall include--
(A) the reasons for the determination (including
the clinical rationale);
(B) instructions on how to initiate an appeal under
section 132; and
(C) notice of the availability, upon request of the
individual (or the individual's designee) of the
clinical review criteria relied upon to make such
determination.
(2) Specification of any additional information.--Such a
notice shall also specify what (if any) additional necessary
information must be provided to, or obtained by, the person
making the determination in order to make a decision on such an
appeal.
SEC. 116. HEALTH CARE QUALITY ADVISORY BOARD.
(a) Establishment.--The President shall establish an advisory board
to provide information to Congress and the administration on issues
relating to quality monitoring and improvement in the health care
provided under group health plans and health insurance coverage.
(b) Number and Appointment.--The advisory board shall be composed
of the Secretary of Health and Human Services (or the Secretary's
designee), the Secretary of Labor (or the Secretary's designee), and 20
additional members appointed by the President, in consultation with the
Majority and Minority Leaders of the Senate and House of
Representatives. The members so appointed shall include individuals
with expertise in--
(1) consumer needs;
(2) education and training of health professionals;
(3) health care services;
(4) health plan management;
(5) health care accreditation, quality assurance,
improvement, measurement, and oversight;
(6) medical practice, including practicing physicians;
(7) prevention and public health; and
(8) public and private group purchasing for small and large
employers or groups.
(c) Duties.--The advisory board shall--
(1) identify, update, and disseminate measures of health
care quality for group health plans and health insurance
issuers, including network and non-network plans;
(2) advise the Secretary on the development and maintenance
of the minimum data set in section 112(b); and
(3) advise the Secretary on standardized formats for
information on group health plans and health insurance
coverage.
The measures identified under paragraph (1) may be used on a voluntary
basis by such plans and issuers. In carrying out paragraph (1), the
advisory board shall consult and cooperate with national health care
standard setting bodies which define quality indicators, the Agency for
Health Care Policy and Research, the Institute of Medicine, and other
public and private entities that have expertise in health care quality.
(d) Report.--The advisory board shall provide an annual report to
Congress and the President on the quality of the health care in the
United States and national and regional trends in health care quality.
Such report shall include a description of determinants of health care
quality and measurements of practice and quality variability within the
United States.
(e) Secretarial Consultation.--In serving on the advisory board,
the Secretaries of Health and Human Services and Labor (or their
designees) shall consult with the Secretaries responsible for other
Federal health insurance and health care programs.
(f) Vacancies.--Any vacancy on the board shall be filled in such
manner as the original appointment. Members of the board shall serve
without compensation but shall be reimbursed for travel, subsistence,
and other necessary expenses incurred by them in the performance of
their duties. Administrative support, scientific support, and technical
assistance for the advisory board shall be provided by the Secretary of
Health and Human Services.
(g) Continuation.--Section 14(a)(2)(B) of the Federal Advisory
Committee Act (5 U.S.C. App.; relating to the termination of advisory
committees) shall not apply to the advisory board.
Subtitle C--Patient Information
SEC. 121. PATIENT INFORMATION.
(a) Disclosure Requirement.--
(1) Group health plans.--A group health plan shall--
(A) provide to participants and beneficiaries at
the time of initial coverage under the plan (or the
effective date of this section, in the case of
individuals who are participants or beneficiaries as of
such date), and at least annually thereafter, the
information described in subsection (b) in printed
form;
(B) provide to participants and beneficiaries,
within a reasonable period (as specified by the
appropriate Secretary) before or after the date of
significant changes in the information described in
subsection (b), information in printed form on such
significant changes; and
(C) upon request, make available to participants
and beneficiaries, the applicable authority, and
prospective participants and beneficiaries, the
information described in subsection (b) or (c) in
printed form.
(2) Health insurance issuers.--A health insurance issuer in
connection with the provision of health insurance coverage
shall--
(A) provide to individuals enrolled under such
coverage at the time of enrollment, and at least
annually thereafter, the information described in
subsection (b) in printed form;
(B) provide to enrollees, within a reasonable
period (as specified by the appropriate Secretary)
before or after the date of significant changes in the
information described in subsection (b), information in
printed form on such significant changes; and
(C) upon request, make available to the applicable
authority, to individuals who are prospective
enrollees, and to the public the information described
in subsection (b) or (c) in printed form.
(b) Information Provided.--The information described in this
subsection with respect to a group health plan or health insurance
coverage offered by a health insurance issuer includes the following:
(1) Service area.--The service area of the plan or issuer.
(2) Benefits.--Benefits offered under the plan or coverage,
including--
(A) covered benefits, including benefit limits and
coverage exclusions;
(B) cost sharing, such as deductibles, coinsurance,
and copayment amounts, including any liability for
balance billing, any maximum limitations on out of
pocket expenses, and the maximum out of pocket costs
for services that are provided by non participating
providers or that are furnished without meeting the
applicable utilization review requirements;
(C) the extent to which benefits may be obtained
from nonparticipating providers;
(D) the extent to which a participant, beneficiary,
or enrollee may select from among participating
providers and the types of providers participating in
the plan or issuer network;
(E) process for determining experimental coverage;
and
(F) use of a prescription drug formulary.
(3) Access.--A description of the following:
(A) The number, mix, and distribution of providers
under the plan or coverage.
(B) Out-of-network coverage (if any) provided by
the plan or coverage.
(C) Any point-of-service option (including any
supplemental premium or cost-sharing for such option).
(D) The procedures for participants, beneficiaries,
and enrollees to select, access, and change
participating primary and specialty providers.
(E) The rights and procedures for obtaining
referrals (including standing referrals) to
participating and nonparticipating providers.
(F) The name, address, and telephone number of
participating health care providers and an indication
of whether each such provider is available to accept
new patients.
(G) Any limitations imposed on the selection of
qualifying participating health care providers,
including any limitations imposed under section
103(b)(2).
(H) How the plan or issuer addresses the needs of
participants, beneficiaries, and enrollees and others
who do not speak English or who have other special
communications needs in accessing providers under the
plan or coverage, including the provision of
information described in this subsection and subsection
(c) to such individuals and including the provision of
information in a language other than English if 5
percent of the number of participants, beneficiaries,
and enrollees communicate in that language instead of
English.
(4) Out-of-area coverage.--Out-of-area coverage provided by
the plan or issuer.
(5) Emergency coverage.--Coverage of emergency services,
including--
(A) the appropriate use of emergency services,
including use of the 911 telephone system or its local
equivalent in emergency situations and an explanation
of what constitutes an emergency situation;
(B) the process and procedures of the plan or
issuer for obtaining emergency services; and
(C) the locations of (i) emergency departments, and
(ii) other settings, in which plan physicians and
hospitals provide emergency services and post-
stabilization care.
(6) Percentage of premiums used for benefits (loss-
ratios).--In the case of health insurance coverage only (and
not with respect to group health plans that do not provide
coverage through health insurance coverage), a description of
the overall loss-ratio for the coverage (as defined in
accordance with rules established or recognized by the
Secretary of Health and Human Services).
(7) Prior authorization rules.--Rules regarding prior
authorization or other review requirements that could result in
noncoverage or nonpayment.
(8) Grievance and appeals procedures.--All appeal or
grievance rights and procedures under the plan or coverage,
including the method for filing grievances and the time frames
and circumstances for acting on grievances and appeals, who is
the applicable authority with respect to the plan or issuer,
and the availability of assistance through an ombudsman to
individuals in relation to group health plans and health
insurance coverage.
(9) Quality assurance.--A summary description of the data
on quality collected under section 112(a), including a summary
description of the data on satisfaction of participants,
beneficiaries, and enrollees (including data on individual
voluntary disenrollment and grievances and appeals) described
in section 112(b)(4).
(10) Summary of provider financial incentives.--A summary
description of the information on the types of financial
payment incentives (described in section 1852(j)(4) of the
Social Security Act) provided by the plan or issuer under the
coverage.
(11) Information on issuer.--Notice of appropriate mailing
addresses and telephone numbers to be used by participants,
beneficiaries, and enrollees in seeking information or
authorization for treatment.
(12) Availability of information on request.--Notice that
the information described in subsection (c) is available upon
request.
(c) Information Made Available Upon Request.--The information
described in this subsection is the following:
(1) Utilization review activities.--A description of
procedures used and requirements (including circumstances, time
frames, and appeal rights) under any utilization review program
under section 115, including under any drug formulary program
under section 107.
(2) Grievance and appeals information.--Information on the
number of grievances and appeals and on the disposition in the
aggregate of such matters.
(3) Method of physician compensation.--An overall summary
description as to the method of compensation of participating
physicians, including information on the types of financial
payment incentives (described in section 1852(j)(4) of the
Social Security Act) provided by the plan or issuer under the
coverage.
(4) Specific information on credentials of participating
providers.--In the case of each participating provider, a
description of the credentials of the provider.
(5) Confidentiality policies and procedures.--A description
of the policies and procedures established to carry out section
122.
(6) Formulary restrictions.--A description of the nature of
any drug formula restrictions.
(7) Participating provider list.--A list of current
participating health care providers.
(d) Form of Disclosure.--
(1) Uniformity.--Information required to be disclosed under
this section shall be provided in accordance with uniform,
national reporting standards specified by the Secretary, after
consultation with applicable State authorities, so that
prospective enrollees may compare the attributes of different
issuers and coverage offered within an area.
(2) Information into handbook.--Nothing in this section
shall be construed as preventing a group health plan or health
insurance issuer from making the information under subsections
(b) and (c) available to participants, beneficiaries, and
enrollees through an enrollee handbook or similar publication.
(3) Updating participating provider information.--The
information on participating health care providers described in
subsection (b)(3)(C) shall be updated within such reasonable
period as determined appropriate by the Secretary. Nothing in
this section shall prevent an issuer from changing or updating
other information made available under this section.
(e) Construction.--Nothing in this section shall be construed as
requiring public disclosure of individual contracts or financial
arrangements between a group health plan or health insurance issuer and
any provider.
SEC. 122. PROTECTION OF PATIENT CONFIDENTIALITY.
Insofar as a group health plan, or a health insurance issuer that
offers health insurance coverage, maintains medical records or other
health information regarding participants, beneficiaries, and
enrollees, the plan or issuer shall establish procedures--
(1) to safeguard the privacy of any individually
identifiable enrollee information;
(2) to maintain such records and information in a manner
that is accurate and timely, and
(3) to assure timely access of such individuals to such
records and information.
SEC. 123. HEALTH INSURANCE OMBUDSMEN.
(a) In General.--Each State that obtains a grant under subsection
(c) shall provide for creation and operation of a Health Insurance
Ombudsman through a contract with a not-for-profit organization that
operates independent of group health plans and health insurance
issuers. Such Ombudsman shall be responsible for at least the
following:
(1) To assist consumers in the State in choosing among
health insurance coverage or among coverage options offered
within group health plans.
(2) To provide counseling and assistance to enrollees
dissatisfied with their treatment by health insurance issuers
and group health plans in regard to such coverage or plans and
with respect to grievances and appeals regarding determinations
under such coverage or plans.
(b) Federal Role.--In the case of any State that does not provide
for such an Ombudsman under subsection (a), the Secretary shall provide
for the creation and operation of a Health Insurance Ombudsman through
a contract with a not-for-profit organization that operates independent
of group health plans and health insurance issuers and that is
responsible for carrying out with respect to that State the functions
otherwise provided under subsection (a) by a Health Insurance
Ombudsman.
(c) Authorization of Appropriations.--There are authorized to be
appropriated to the Secretary of Health and Human Services such amounts
as may be necessary to provide for grants to States for contracts for
Health Insurance Ombudsmen under subsection (a) or contracts for such
Ombudsmen under subsection (b).
(d) Construction.--Nothing in this section shall be construed to
prevent the use of other forms of enrollee assistance.
Subtitle D--Grievance and Appeals Procedures
SEC. 131. ESTABLISHMENT OF GRIEVANCE PROCESS.
(a) Establishment of Grievance System.--
(1) In general.--A group health plan, and a health
insurance issuer in connection with the provision of health
insurance coverage, shall establish and maintain a system to
provide for the presentation and resolution of oral and written
grievances brought by individuals who are participants,
beneficiaries, or enrollees, or health care providers or other
individuals acting on behalf of an individual and with the
individual's consent, regarding any aspect of the plan's or
issuer's services.
(2) Scope.--The system shall include grievances regarding
access to and availability of services, quality of care, choice
and accessibility of providers, network adequacy, and
compliance with the requirements of this title.
(b) Grievance System.--Such system shall include the following
components with respect to individuals who are participants,
beneficiaries, or enrollees:
(1) Written notification to all such individuals and
providers of the telephone numbers and business addresses of
the plan or issuer personnel responsible for resolution of
grievances and appeals.
(2) A system to record and document, over a period of at
least 3 previous years, all grievances and appeals made and
their status.
(3) A process providing for timely processing and
resolution of grievances.
(4) Procedures for follow-up action, including the methods
to inform the person making the grievance of the resolution of
the grievance.
(5) Notification to the continuous quality improvement
program under section 111(a) of all grievances and appeals
relating to quality of care.
SEC. 132. INTERNAL APPEALS OF ADVERSE DETERMINATIONS.
(a) Right of Appeal.--
(1) In general.--A participant or beneficiary in a group
health plan, and an enrollee in health insurance coverage
offered by a health insurance issuer, and any provider or other
person acting on behalf of such an individual with the
individual's consent, may appeal any appealable decision (as
defined in paragraph (2)) under the procedures described in
this section and (to the extent applicable) section 133. Such
individuals and providers shall be provided with a written
explanation of the appeal process and the determination upon
the conclusion of the appeals process and as provided in
section 121(b)(8).
(2) Appealable decision defined.--In this section, the term
``appealable decision'' means any of the following:
(A) Denial, reduction, or termination of, or
failure to provide or make payment (in whole or in
part) for a benefit, including a failure to cover an
item or service for which benefits are otherwise
provided because it is determined to be experimental or
investigational or not medically necessary or
appropriate.
(B) Failure to provide coverage of emergency
services or reimbursement of maintenance care or post-
stabilization care under section 101.
(C) Failure to provide a choice of provider under
section 103.
(D) Failure to provide qualified health care
providers under section 103.
(E) Failure to provide access to specialty and
other care under section 104.
(F) Failure to provide continuation of care under
section 105.
(G) Failure to provide coverage of routine patient
costs in connection with an approval clinical trial
under section 106.
(H) Failure to provide access to needed drugs under
section 107(a)(3) or 107(b).
(I) Discrimination in delivery of services in
violation of section 109.
(J) An adverse determination under a utilization
review program under section 115.
(K) The imposition of a limitation that is
prohibited under section 151.
(b) Internal Appeal Process.--
(1) In general.--Each group health plan and health
insurance issuer shall establish and maintain an internal
appeal process under which any participant, beneficiary, or
enrollee, or any provider or other person acting on behalf of
such an individual with the individual's consent, who is
dissatisfied with any appealable decision has the opportunity
to appeal the decision through an internal appeal process. The
appeal may be communicated orally.
(2) Conduct of review.--
(A) In general.--The process shall include a review
of the decision by a physician or other health care
professional (or professionals) who has been selected
by the plan or issuer and who has not been involved in
the appealable decision at issue in the appeal.
(B) Availability and participation of clinical
peers.--The individuals conducting such review shall
include one or more clinical peers (as defined in
section 191(c)(2)) who have not been involved in the
appealable decision at issue in the appeal.
(3) Deadline.--
(A) In general.--Subject to subsection (c), the
plan or issuer shall conclude each appeal as soon as
possible after the time of the receipt of the appeal in
accordance with medical exigencies of the case
involved, but in no event later than--
(i) 72 hours after the time of receipt of
an expedited appeal, and
(ii) except as provided in subparagraph
(B), 30 business days after such time (or, if
the participant, beneficiary, or enrollee
supplies additional information that was not
available to the plan or issuer at the time of
the receipt of the appeal, after the date of
supplying such additional information) in the
case of all other appeals.
(B) Extension.--In the case of an appeal that does
not relate to a decision regarding an expedited appeal
and that does not involve medical exigencies, if a
group health plan or health insurance issuer is unable
to conclude the appeal within the time period provided
under subparagraph (A)(ii) due to circumstances beyond
the control of the plan or issuer, the deadline shall
be extended for up to an additional 10 business days if
the plan or issuer provides, on or before 10 days
before the deadline otherwise applicable, written
notice to the participant, beneficiary, or enrollee and
the provider involved of the extension and the reasons
for the extension.
(4) Notice.--If a plan or issuer denies an appeal, the plan
or issuer shall provide the participant, beneficiary, or
enrollee and provider involved with notice in printed form of
the denial and the reasons therefore, together with a notice in
printed form of rights to any further appeal.
(c) Expedited Review Process.--
(1) In general.--A group health plan, and a health
insurance issuer, shall establish procedures in writing for the
expedited consideration of appeals under subsection (b) in
situations in which the application of the normal timeframe for
making a determination could seriously jeopardize the life or
health of the participant, beneficiary, or enrollee (including
in the case of a child, development) or such an individual's
ability to regain maximum function.
(2) Process.--Under such procedures--
(A) the request for expedited appeal may be
submitted orally or in writing by an individual or
provider who is otherwise entitled to request the
appeal;
(B) all necessary information, including the plan's
or issuer's decision, shall be transmitted between the
plan or issuer and the requester by telephone,
facsimile, or other similarly expeditious available
method; and
(C) the plan or issuer shall expedite the appeal if
the request for an expedited appeal is submitted under
subparagraph (A) by a physician and the request
indicates that the situation described in paragraph (1)
exists.
(d) Direct Use of Further Appeals.--In the event that the plan or
issuer fails to comply with any of the deadlines for completion of
appeals under this section or in the event that the plan or issuer for
any reason expressly waives its rights to an internal review of an
appeal under subsection (b), the participant, beneficiary, or enrollee
involved and the provider involved shall be relieved of any obligation
to complete the appeal involved and may, at such an individual's or
provider's option, proceed directly to seek further appeal through any
applicable external appeals process.
SEC. 133. EXTERNAL APPEALS OF ADVERSE DETERMINATIONS.
(a) Right to External Appeal.--
(1) In general.--A group health plan, and a health
insurance issuer offering group health insurance coverage,
shall provide for an external appeals process that meets the
requirements of this section in the case of an externally
appealable decision described in paragraph (2). The appropriate
Secretary shall establish standards to carry out such
requirements.
(2) Externally appealable decision defined.--For purposes
of this section, the term ``externally appealable decision''
means an appealable decision (as defined in section 132(a)(2))
if--
(A) the amount involved exceeds a significant
threshold; or
(B) the patient's life or health is jeopardized
(including, in the case of a child, development) as a
consequence of the decision.
Such term does not include a denial of coverage for services
that are specifically listed in plan or coverage documents as
excluded from coverage.
(3) Exhaustion of internal appeals process.--A plan or
issuer may condition the use of an external appeal process in
the case of an externally appealable decision upon completion
of the internal review process provided under section 132, but
only if the decision is made in a timely basis consistent with
the deadlines provided under this subtitle.
(b) General Elements of External Appeals Process.--
(1) Contract with qualified external appeal entity.--
(A) Contract requirement.--Subject to subparagraph
(B), the external appeal process under this section of
a plan or issuer shall be conducted under a contract
between the plan or issuer and one or more qualified
external appeal entities (as defined in subsection
(c)).
(B) Restrictions on qualified external appeal
entity.--
(i) By state for health insurance
issuers.--With respect to health insurance
issuers in a State, the State may provide for
external review activities to be conducted by a
qualified external appeal entity that is
designated by the State or that is selected by
the State in such a manner as to assure an
unbiased determination.
(ii) By federal government for group health
plans.--With respect to group health plans, the
appropriate Secretary may exercise the same
authority as a State may exercise with respect
to health insurance issuers under clause (i).
Such authority may include requiring the use of
the qualified external appeal entity designated
or selected under such clause.
(iii) Limitation on plan or issuer
selection.--If an applicable authority permits
more than one entity to qualify as a qualified
external appeal entity with respect to a group
health plan or health insurance issuer and the
plan or issuer may select among such qualified
entities, the applicable authority--
(I) shall assure that the selection
process will not create any incentives
for external appeal entities to make a
decision in a biased manner, and
(II) shall implement procedures for
auditing a sample of decisions by such
entities to assure that no such
decisions are made in a biased manner.
(C) Other terms and conditions.--The terms and
conditions of a contract under this paragraph shall be
consistent with the standards the appropriate Secretary
shall establish to assure there is no real or apparent
conflict of interest in the conduct of external appeal
activities. Such contract shall provide that the direct
costs of the process (not including costs of
representation of a participant, beneficiary, or
enrollee) shall be paid by the plan or issuer, and not
by the participant, beneficiary, or enrollee.
(2) Elements of process.--An external appeal process shall
be conducted consistent with standards established by the
appropriate Secretary that include at least the following:
(A) Fair process; de novo determination.--The
process shall provide for a fair, de novo
determination.
(B) Determination concerning externally appealable
decisions.--A qualified external appeal entity shall
determine whether a decision is an externally
appealable decision and related decisions, including--
(i) whether such a decision involves an
expedited appeal;
(ii) the appropriate deadlines for internal
review process required due to medical
exigencies in a case; and
(iii) whether such a process has been
completed.
(C) Opportunity to submit evidence, have
representation, and make oral presentation.--Each party
to an externally appealable decision--
(i) may submit and review evidence related
to the issues in dispute,
(ii) may use the assistance or
representation of one or more individuals (any
of whom may be an attorney), and
(iii) may make an oral presentation.
(D) Provision of information.--The plan or issuer
involved shall provide timely access to all its records
relating to the matter of the externally appealable
decision and to all provisions of the plan or health
insurance coverage (including any coverage manual)
relating to the matter.
(E) Timely decisions.--A determination by the
external appeal entity on the decision shall--
(i) be made orally or in writing and, if it
is made orally, shall be supplied to the
parties in writing as soon as possible;
(ii) be binding on the plan or issuer;
(iii) be made in accordance with the
medical exigencies of the case involved, but in
no event later than 60 days (or 72 hours in the
case of an expedited appeal) from the date of
completion of the filing of notice of external
appeal of the decision;
(iv) state, in layperson's language, the
basis for the determination, including, if
relevant, any basis in the terms or conditions
of the plan or coverage; and
(v) inform the participant, beneficiary, or
enrollee of the individual's rights to seek
further review by the courts (or other process)
of the external appeal determination.
(c) Qualifications of External Appeal Entities.--
(1) In general.--For purposes of this section, the term
``qualified external appeal entity'' means, in relation to a
plan or issuer, an entity (which may be a governmental entity)
that is certified under paragraph (2) as meeting the following
requirements:
(A) There is no real or apparent conflict of
interest that would impede the entity conducting
external appeal activities independent of the plan or
issuer.
(B) The entity conducts external appeal activities
through clinical peers.
(C) The entity has sufficient medical, legal, and
other expertise and sufficient staffing to conduct
external appeal activities for the plan or issuer on a
timely basis consistent with subsection (b)(3)(E).
(D) The entity meets such other requirements as the
appropriate Secretary may impose.
(2) Certification of external appeal entities.--
(A) In general.--In order to be treated as a
qualified external appeal entity with respect to--
(i) a group health plan, the entity must be
certified (and, in accordance with subparagraph
(B), periodically recertified) as meeting the
requirements of paragraph (1) by the Secretary
of Labor (or under a process recognized or
approved by the Secretary of Labor); or
(ii) a health insurance issuer operating in
a State, the entity must be certified (and, in
accordance with subparagraph (B), periodically
recertified) as meeting such requirements by
the applicable State authority (or, if the
State has not established an adequate
certification and recertification process, by
the Secretary of Health and Human Services, or
under a process recognized or approved by such
Secretary).
(B) Recertification process.--The appropriate
Secretary shall develop standards for the
recertification of external appeal entities. Such
standards shall include a specification of--
(i) the information required to be
submitted as a condition of recertification on
the entity's performance of external appeal
activities, which information shall include the
number of cases reviewed, a summary of the
disposition of those cases, the length of time
in making determinations on those cases, and
such information as may be necessary to assure
the independence of the entity from the plans
or issuers for which external appeal activities
are being conducted; and
(ii) the periodicity which recertification
will be required.
(d) Continuing Legal Rights of Enrollees.--Nothing in this title
shall be construed as removing any legal rights of participants,
beneficiaries, enrollees, and others under State or Federal law,
including the right to file judicial actions to enforce rights.
Subtitle E--Protecting the Doctor-Patient Relationship
SEC. 141. PROHIBITION OF INTERFERENCE WITH CERTAIN MEDICAL
COMMUNICATIONS.
(a) Prohibition.--
(1) General rule.--The provisions of any contract or
agreement, or the operation of any contract or agreement,
between a group health plan or health insurance issuer in
relation to health insurance coverage (including any
partnership, association, or other organization that enters
into or administers such a contract or agreement) and a health
care provider (or group of health care providers) shall not
prohibit or restrict the provider from engaging in medical
communications with the provider's patient.
(2) Nullification.--Any contract provision or agreement
that restricts or prohibits medical communications in violation
of paragraph (1) shall be null and void.
(b) Rules of Construction.--Nothing in this section shall be
construed--
(1) to prohibit the enforcement, as part of a contract or
agreement to which a health care provider is a party, of any
mutually agreed upon terms and conditions, including terms and
conditions requiring a health care provider to participate in,
and cooperate with, all programs, policies, and procedures
developed or operated by a group health plan or health
insurance issuer to assure, review, or improve the quality and
effective utilization of health care services (if such
utilization is according to guidelines or protocols that are
based on clinical or scientific evidence and the professional
judgment of the provider) but only if the guidelines or
protocols under such utilization do not prohibit or restrict
medical communications between providers and their patients; or
(2) to permit a health care provider to misrepresent the
scope of benefits covered under the group health plan or health
insurance coverage or to otherwise require a group health plan
health insurance issuer to reimburse providers for benefits not
covered under the plan or coverage.
(c) Medical Communication Defined.--In this section:
(1) In general.--The term ``medical communication'' means
any communication made by a health care provider with a patient
of the health care provider (or the guardian or legal
representative of such patient) with respect to--
(A) the patient's health status, medical care, or
treatment options;
(B) any utilization review requirements that may
affect treatment options for the patient; or
(C) any financial incentives that may affect the
treatment of the patient.
(2) Misrepresentation.--The term ``medical communication''
does not include a communication by a health care provider with
a patient of the health care provider (or the guardian or legal
representative of such patient) if the communication involves a
knowing or willful misrepresentation by such provider.
SEC. 142. PROHIBITION AGAINST TRANSFER OF INDEMNIFICATION OR IMPROPER
INCENTIVE ARRANGEMENTS.
(a) Prohibition of Transfer of Indemnification.--
(1) In general.--No contract or agreement between a group
health plan or health insurance issuer (or any agent acting on
behalf of such a plan or issuer) and a health care provider
shall contain any provision purporting to transfer to the
health care provider by indemnification or otherwise any
liability relating to activities, actions, or omissions of the
plan, issuer, or agent (as opposed to the provider).
(2) Nullification.--Any contract or agreement provision
described in paragraph (1) shall be null and void.
(b) Prohibition of Improper Physician Incentive Plans.--
(1) In general.--A group health plan and a health insurance
issuer offering health insurance coverage may not operate any
physician incentive plan (as defined in subparagraph (B) of
section 1876(i)(8) of the Social Security Act) unless the
requirements described in subparagraph (A) of such section are
met with respect to such a plan.
(2) Application.--For purposes of carrying out paragraph
(1), any reference in section 1876(i)(8) of the Social Security
Act to the Secretary, an eligible organization, or an
individual enrolled with the organization shall be treated as a
reference to the applicable authority, a group health plan or
health insurance issuer, respectively, and a participant,
beneficiary, or enrollee with the plan or organization,
respectively.
SEC. 143. ADDITIONAL RULES REGARDING PARTICIPATION OF HEALTH CARE
PROFESSIONALS.
(a) Procedures.--Insofar as a group health plan, or health
insurance issuer that offers health insurance coverage, provides
benefits through participating health care professionals, the plan or
issuer shall establish reasonable procedures relating to the
participation (under an agreement between a professional and the plan
or issuer) of such professionals under the plan or coverage. Such
procedures shall include--
(1) providing notice of the rules regarding participation;
(2) providing written notice of participation decisions
that are adverse to professionals; and
(3) providing a process within the plan or issuer for
appealing such adverse decisions, including the presentation of
information and views of the professional regarding such
decision.
(b) Consultation in Medical Policies.--A group health plan, and
health insurance issuer that offers health insurance coverage, shall
consult with participating physicians (if any) regarding the plan's or
issuer's medical policy, quality, and medical management procedures.
SEC. 144. PROTECTION FOR PATIENT ADVOCACY.
(a) Protection for Use of Utilization Review and Grievance
Process.--A group health plan, and a health insurance issuer with
respect to the provision of health insurance coverage, may not
retaliate against a participant, beneficiary, enrollee, or health care
provider based on the participant's, beneficiary's, enrollee's or
provider's use of, or participation in, a utilization review process or
a grievance process of the plan or issuer (including an internal or
external review or appeal process) under this title.
(b) Protection for Quality Advocacy by Health Care Professionals.--
(1) In general.--A group health plan or health insurance
issuer may not retaliate or discriminate against a protected
health care professional because the professional in good
faith--
(A) discloses information relating to the care,
services, or conditions affecting one or more
participants, beneficiaries, or enrollees of the plan
or issuer to an appropriate public regulatory agency,
an appropriate private accreditation body, or
appropriate management personnel of the plan or issuer;
or
(B) initiates, cooperates, or otherwise
participates in an investigation or proceeding by such
an agency with respect to such care, services, or
conditions.
If an institutional health care provider is a participating
provider with such a plan or issuer or otherwise receives
payments for benefits provided by such a plan or issuer, the
provisions of the previous sentence shall apply to the provider
in relation to care, services, or conditions affecting one or
more patients within an institutional health care provider in
the same manner as they apply to the plan or issuer in relation
to care, services, or conditions provided to one or more
participants, beneficiaries, or enrollees; and for purposes of
applying this sentence, any reference to a plan or issuer is
deemed a reference to the institutional health care provider.
(2) Good faith action.--For purposes of paragraph (1), a
protected health care professional is considered to be acting
in good faith with respect to disclosure of information or
participation if, with respect to the information disclosed as
part of the action--
(A) the disclosure is made on the basis of personal
knowledge and is consistent with that degree of
learning and skill ordinarily possessed by health care
professionals with the same licensure or certification
and the same experience;
(B) the professional reasonably believes the
information to be true;
(C) the information evidences either a violation of
a law, rule, or regulation, of an applicable
accreditation standard, or of a generally recognized
professional or clinical standard or that a patient is in imminent
hazard of loss of life or serious injury; and
(D) subject to subparagraphs (B) and (C) of
paragraph (3), the professional has followed reasonable
internal procedures of the plan, issuer, or
institutional health care provider established for the
purpose of addressing quality concerns before making
the disclosure.
(3) Exception and special rule.--
(A) General exception.--Paragraph (1) does not
protect disclosures that would violate Federal or State
law or diminish or impair the rights of any person to
the continued protection of confidentiality of
communications provided by such law.
(B) Notice of internal procedures.--Subparagraph
(D) of paragraph (2) shall not apply unless the
internal procedures involved are reasonably expected to
be known to the health care professional involved. For
purposes of this subparagraph, a health care
professional is reasonably expected to know of internal
procedures if those procedures have been made available
to the professional through distribution or posting.
(C) Internal procedure exception.--Subparagraph (D)
of paragraph (2) also shall not apply if--
(i) the disclosure relates to an imminent
hazard of loss of life or serious injury to a
patient;
(ii) the disclosure is made to an
appropriate private accreditation body pursuant
to disclosure procedures established by the
body; or
(iii) the disclosure is in response to an
inquiry made in an investigation or proceeding
of an appropriate public regulatory agency and
the information disclosed is limited to the
scope of the investigation or proceeding.
(4) Additional considerations.--It shall not be a violation
of paragraph (1) to take an adverse action against a protected
health care professional if the plan, issuer, or provider
taking the adverse action involved demonstrates that it would
have taken the same adverse action even in the absence of the
activities protected under such paragraph.
(5) Notice.--A group health plan, health insurance issuer,
and institutional health care provider shall post a notice, to
be provided or approved by the Secretary of Labor, setting
forth excerpts from, or summaries of, the pertinent provisions
of this subsection and information pertaining to enforcement of
such provisions.
(6) Constructions.--
(A) Determinations of coverage.--Nothing in this
subsection shall be construed to prohibit a plan or
issuer from making a determination not to pay for a
particular medical treatment or service or the services
of a type of health care professional.
(B) Enforcement of peer review protocols and
internal procedures.--Nothing in this subsection shall
be construed to prohibit a plan, issuer, or provider
from establishing and enforcing reasonable peer review
or utilization review protocols or determining whether
a protected health care professional has complied with
those protocols or from establishing and enforcing
internal procedures for the purpose of addressing
quality concerns.
(C) Relation to other rights.--Nothing in this
subsection shall be construed to abridge rights of
participants, beneficiaries, enrollees, and protected
health care professionals under other applicable
Federal or State laws.
(7) Protected health care professional defined.--For
purposes of this subsection, the term ``protected health care
professional'' means an individual who is a licensed or
certified health care professional and who--
(A) with respect to a group health plan or health
insurance issuer, is an employee of the plan or issuer
or has a contract with the plan or issuer for provision
of services for which benefits are available under the
plan or issuer; or
(B) with respect to an institutional health care
provider, is an employee of the provider or has a
contract or other arrangement with the provider
respecting the provision of health care services.
Subtitle F--Promoting Good Medical Practice
SEC. 151. PROMOTING GOOD MEDICAL PRACTICE.
(a) Prohibiting Arbitrary Limitations or Conditions for the
Provision of Services.--
(1) In general.--A group health plan, and a health
insurance issuer in connection with the provision of health
insurance coverage, may not arbitrarily interfere with or alter
the decision of the treating physician regarding the manner or
setting in which particular services are delivered if the
services are medically necessary or appropriate for treatment
or diagnosis to the extent that such treatment or diagnosis is
otherwise a covered benefit.
(2) Construction.--Paragraph (1) shall not be construed as
prohibiting a plan or issuer from limiting the delivery of
services to one or more health care providers within a network
of such providers.
(3) Manner or setting defined.--In paragraph (1), the term
``manner or setting'' means the location of treatment, such as
whether treatment is provided on an inpatient or outpatient
basis, and the duration of treatment, such as the number of
days in a hospital. Such term does not include the coverage of
a particular service or treatment.
(b) No Change in Coverage.--Subsection (a) shall not be construed
as requiring coverage of particular services the coverage of which is
otherwise not covered under the terms of the plan or coverage or from
conducting utilization review activities consistent with this
subsection.
(c) Medical Necessity or Appropriateness Defined.--In subsection
(a), the term ``medically necessary or appropriate'' means, with
respect to a service or benefit, a service or benefit which is
consistent with generally accepted principles of professional medical
practice.
SEC. 152. STANDARDS RELATING TO BENEFITS FOR CERTAIN BREAST CANCER
TREATMENT.
(a) Inpatient Care.--
(1) In general.--A group health plan, and a health
insurance issuer offering group health insurance coverage, that
provides medical and surgical benefits shall ensure that
inpatient coverage with respect to the treatment of breast
cancer is provided for a period of time as is determined by the
attending physician, in his or her professional judgment
consistent with generally accepted medical standards, in
consultation with the patient, to be medically appropriate
following--
(A) a mastectomy;
(B) a lumpectomy; or
(C) a lymph node dissection for the treatment of
breast cancer.
(2) Exception.--Nothing in this section shall be construed
as requiring the provision of inpatient coverage if the
attending physician and patient determine that a shorter period
of hospital stay is medically appropriate.
(b) Prohibitions.--A group health plan, and a health insurance
issuer offering group health insurance coverage in connection with a
group health plan, may not--
(1) deny to a woman eligibility, or continued eligibility,
to enroll or to renew coverage under the terms of the plan,
solely for the purpose of avoiding the requirements of this
section;
(2) provide monetary payments or rebates to women to
encourage such women to accept less than the minimum
protections available under this section;
(3) penalize or otherwise reduce or limit the reimbursement
of an attending provider because such provider provided care to
an individual participant or beneficiary in accordance with
this section;
(4) provide incentives (monetary or otherwise) to an
attending provider to induce such provider to provide care to
an individual participant or beneficiary in a manner
inconsistent with this section; or
(5) subject to subsection (c)(3), restrict benefits for any
portion of a period within a hospital length of stay required
under subsection (a) in a manner which is less favorable than
the benefits provided for any preceding portion of such stay.
(c) Rules of Construction.--
(1) Nothing in this section shall be construed to require a
woman who is a participant or beneficiary--
(A) to undergo a mastectomy or lymph node
dissection in a hospital; or
(B) to stay in the hospital for a fixed period of
time following a mastectomy or lymph node dissection.
(2) This section shall not apply with respect to any group
health plan, or any group health insurance coverage offered by
a health insurance issuer, which does not provide benefits for
hospital lengths of stay in connection with a mastectomy or
lymph node dissection for the treatment of breast cancer.
(3) Nothing in this section shall be construed as
preventing a group health plan or issuer from imposing
deductibles, coinsurance, or other cost-sharing in relation to
benefits for hospital lengths of stay in connection with a
mastectomy or lymph node dissection for the treatment of breast
cancer under the plan (or under health insurance coverage
offered in connection with a group health plan), except that
such coinsurance or other cost-sharing for any portion of a
period within a hospital length of stay required under
subsection (a) may not be greater than such coinsurance or
cost-sharing for any preceding portion of such stay.
(d) Level and Type of Reimbursements.--Nothing in this section
shall be construed to prevent a group health plan or a health insurance
issuer offering group health insurance coverage from negotiating the
level and type of reimbursement with a provider for care provided in
accordance with this section.
(e) Exception for Health Insurance Coverage in Certain States.--
(1) In general.--The requirements of this section shall not
apply with respect to health insurance coverage if there is a
State law (as defined in section 2723(d)(1) of the Public
Health Service Act) for a State that regulates such coverage
that is described in any of the following subparagraphs:
(A) Such State law requires such coverage to
provide for at least a 48-hour hospital length of stay
following a mastectomy performed for treatment of
breast cancer and at least a 24-hour hospital length of
stay following a lymph node dissection for treatment of
breast cancer.
(B) Such State law requires, in connection with
such coverage for surgical treatment of breast cancer,
that the hospital length of stay for such care is left
to the decision of (or required to be made by) the
attending provider in consultation with the woman
involved.
(2) Construction.--Section 2723(a)(1) of the Public Health
Service Act and section 731(a)(1) of the Employee Retirement
Income Security Act of 1974 shall not be construed as
superseding a State law described in paragraph (1).
Subtitle G--Definitions
SEC. 191. DEFINITIONS.
(a) Incorporation of General Definitions.--The provisions of
section 2971 of the Public Health Service Act shall apply for purposes
of this title in the same manner as they apply for purposes of title
XXVII of such Act.
(b) Secretary.--Except as otherwise provided, the term
``Secretary'' means the Secretary of Health and Human Services, in
consultation with the Secretary of Labor and the Secretary of the
Treasury and the term ``appropriate Secretary'' means the Secretary of
Health and Human Services in relation to carrying out this title under
sections 2707 and 2753 of the Public Health Service Act, the Secretary
of Labor in relation to carrying out this title under section 714 of
the Employee Retirement Income Security Act of 1974, and the Secretary
of the Treasury in relation to carrying out this title under chapter
100 and section 4980D of the Internal Revenue Code of 1986.
(c) Additional Definitions.--For purposes of this title:
(1) Applicable authority.--The term ``applicable
authority'' means--
(A) in the case of a group health plan, the
Secretary of Health and Human Services and the
Secretary of Labor; and
(B) in the case of a health insurance issuer with
respect to a specific provision of this title, the
applicable State authority (as defined in section
2791(d) of the Public Health Service Act), or the
Secretary of Health and Human Services, if such
Secretary is enforcing such provision under section
2722(a)(2) or 2761(a)(2) of the Public Health Service
Act.
(2) Clinical peer.--The term ``clinical peer'' means, with
respect to a review or appeal, a physician (allopathic or
osteopathic) or other health care professional who holds a non-
restricted license in a State and who is appropriately
credentialed in the same or similar specialty as typically
manages the medical condition, procedure, or treatment under
review or appeal and includes a pediatric specialist where
appropriate; except that only a physician may be a clinical
peer with respect to the review or appeal of treatment rendered
by a physician.
(3) Health care provider.--The term ``health care
provider'' includes a physician or other health care
professional, as well as an institutional provider of health
care services.
(4) Nonparticipating.--The term ``nonparticipating'' means,
with respect to a health care provider that provides health
care items and services to a participant, beneficiary, or enrollee
under group health plan or health insurance coverage, a health care
provider that is not a participating health care provider with respect
to such items and services.
(5) Participating.--The term ``participating'' means, with
respect to a health care provider that provides health care
items and services to a participant, beneficiary, or enrollee
under group health plan or health insurance coverage offered by
a health insurance issuer, a health care provider that
furnishes such items and services under a contract or other
arrangement with the plan or issuer.
SEC. 192. PREEMPTION; STATE FLEXIBILITY; CONSTRUCTION.
(a) Continued Applicability of State Law With Respect to Health
Insurance Issuers.--
(1) In general.--Subject to paragraph (2), this title shall
not be construed to supersede any provision of State law which
establishes, implements, or continues in effect any standard or
requirement solely relating to health insurance issuers in
connection with group health insurance coverage except to the
extent that such standard or requirement prevents the
application of a requirement of this title.
(2) Continued preemption with respect to group health
plans.--Nothing in this title shall be construed to affect or
modify the provisions of section 514 of the Employee Retirement
Income Security Act of 1974 with respect to group health plans.
(b) Rules of Construction.--Except as provided in section 152,
nothing in this title shall be construed as requiring a group health
plan or health insurance coverage to provide specific benefits under
the terms of such plan or coverage.
(c) Definitions.--For purposes of this section:
(1) State law.--The term ``State law'' includes all laws,
decisions, rules, regulations, or other State action having the
effect of law, of any State. A law of the United States
applicable only to the District of Columbia shall be treated as
a State law rather than a law of the United States.
(2) State.--The term ``State'' includes a State, the
Northern Mariana Islands, any political subdivisions of a State
or such Islands, or any agency or instrumentality of either.
SEC. 193. REGULATIONS.
The Secretaries of Health and Human Services, Labor, and the
Treasury shall issue such regulations as may be necessary or
appropriate to carry out this title. Such regulations shall be issued
consistent with section 104 of Health Insurance Portability and
Accountability Act of 1996. Such Secretaries may promulgate any interim
final rules as the Secretaries determine are appropriate to carry out
this title.
TITLE II--APPLICATION OF PATIENT PROTECTION STANDARDS TO GROUP HEALTH
PLANS AND HEALTH INSURANCE COVERAGE UNDER PUBLIC HEALTH SERVICE ACT
SEC. 201. APPLICATION TO GROUP HEALTH PLANS AND GROUP HEALTH INSURANCE
COVERAGE.
(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. PATIENT PROTECTION STANDARDS.
``(a) In General.--Each group health plan shall comply with patient
protection requirements under title I of the Patients' Bill of Rights
Act of 1999, and each health insurance issuer shall comply with patient
protection requirements under such title with respect to group health
insurance coverage it offers, and such requirements shall be deemed to
be incorporated into this subsection.
``(b) Notice.--A group health plan shall comply with the notice
requirement under section 711(d) of the Employee Retirement Income
Security Act of 1974 with respect to the requirements referred to in
subsection (a) and a health insurance issuer shall comply with such
notice requirement as if such section applied to such issuer and such
issuer were a group health plan.''.
(b) Conforming Amendment.--Section 2721(b)(2)(A) of the Public
Health Service Act (42 U.S.C. 300gg-21(b)(2)(A)) is amended by
inserting ``(other than section 2707)'' after ``requirements of such
subparts''.
SEC. 202. APPLICATION TO INDIVIDUAL HEALTH INSURANCE COVERAGE.
Subpart 3 of part B 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. 2753. PATIENT PROTECTION STANDARDS.
``(a) In General.--Each health insurance issuer shall comply with
patient protection requirements under title I of the Patients' Bill of
Rights Act of 1999 with respect to individual health insurance coverage
it offers, and such requirements shall be deemed to be incorporated
into this subsection.
``(b) Notice.--A health insurance issuer under this part shall
comply with the notice requirement under section 711(d) of the Employee
Retirement Income Security Act of 1974 with respect to the requirements
of such title as if such section applied to such issuer and such issuer
were a group health plan.''.
TITLE III--AMENDMENTS TO THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF
1974
SEC. 301. APPLICATION OF PATIENT PROTECTION STANDARDS TO GROUP HEALTH
PLANS AND GROUP HEALTH INSURANCE COVERAGE UNDER THE
EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974.
(a) In General.--Subpart B of part 7 of subtitle B of title I of
the Employee Retirement Income Security Act of 1974, 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. PATIENT PROTECTION STANDARDS.
``(a) In General.--Subject to subsection (b), a group health plan
(and a health insurance issuer offering group health insurance coverage
in connection with such a plan) shall comply with the requirements of
title I of the Patients' Bill of Rights Act of 1999 (as in effect as of
the date of the enactment of such Act), and such requirements shall be
deemed to be incorporated into this subsection.
``(b) Plan Satisfaction of Certain Requirements.--
``(1) Satisfaction of certain requirements through
insurance.--For purposes of subsection (a), insofar as a group
health plan provides benefits in the form of health insurance
coverage through a health insurance issuer, the plan shall be
treated as meeting the following requirements of title I of the
Patients' Bill of Rights Act of 1999 with respect to such
benefits and not be considered as failing to meet such
requirements because of a failure of the issuer to meet such
requirements so long as the plan sponsor or its representatives
did not cause such failure by the issuer:
``(A) Section 101 (relating to access to emergency
care).
``(B) Section 102(a)(1) (relating to offering
option to purchase point-of-service coverage), but only
insofar as the plan is meeting such requirement through
an agreement with the issuer to offer the option to
purchase point-of-service coverage under such section.
``(C) Section 103 (relating to choice of
providers).
``(D) Section 104 (relating to access to specialty
care).
``(E) Section 105(a)(1) (relating to continuity in
case of termination of provider contract) and section
105(a)(2) (relating to continuity in case of
termination of issuer contract), but only insofar as a
replacement issuer assumes the obligation for
continuity of care.
``(F) Section 106 (relating to coverage for
individuals participating in approved clinical trials.)
``(G) Section 107 (relating to access to needed
prescription drugs).
``(H) Section 108 (relating to adequacy of provider
network).
``(I) Subtitle B (relating to quality assurance).
``(J) Section 143 (relating to additional rules
regarding participation of health care professionals).
``(K) Section 152 (relating to standards relating
to benefits for certain breast cancer treatment).
``(2) Information.--With respect to information required to
be provided or made available under section 121, in the case of
a group health plan that provides benefits in the form of
health insurance coverage through a health insurance issuer,
the Secretary shall determine the circumstances under which the
plan is not required to provide or make available the
information (and is not liable for the issuer's failure to
provide or make available the information), if the issuer is
obligated to provide and make available (or provides and makes
available) such information.
``(3) Grievance and internal appeals.--With respect to the
grievance system and internal appeals process required to be
established under sections 131 and 132, in the case of a group
health plan that provides benefits in the form of health
insurance coverage through a health insurance issuer, the
Secretary shall determine the circumstances under which the
plan is not required to provide for such system and process
(and is not liable for the issuer's failure to provide for such
system and process), if the issuer is obligated to provide for
(and provides for) such system and process.
``(4) External appeals.--Pursuant to rules of the
Secretary, insofar as a group health plan enters into a
contract with a qualified external appeal entity for the
conduct of external appeal activities in accordance with
section 133, the plan shall be treated as meeting the
requirement of such section and is not liable for the entity's
failure to meet any requirements under such section.
``(5) Application to prohibitions.--Pursuant to rules of
the Secretary, if a health insurance issuer offers health
insurance coverage in connection with a group health plan and
takes an action in violation of any of the following sections,
the group health plan shall not be liable for such violation
unless the plan caused such violation:
``(A) Section 109 (relating to nondiscrimination in
delivery of services).
``(B) Section 141 (relating to prohibition of
interference with certain medical communications).
``(C) Section 142 (relating to prohibition against
transfer of indemnification or improper incentive
arrangements).
``(D) Section 144 (relating to prohibition on
retaliation).
``(E) Section 151 (relating to promoting good
medical practice).
``(6) Construction.--Nothing in this subsection shall be
construed to affect or modify the responsibilities of the
fiduciaries of a group health plan under part 4 of subtitle B.
``(7) Application to certain prohibitions against
retaliation.--With respect to compliance with the requirements
of section 144(b)(1) of the Patients' Bill of Rights Act of
1999, for purposes of this subtitle the term `group health
plan' is deemed to include a reference to an institutional
health care provider.
``(c) Enforcement of Certain Requirements.--
``(1) Complaints.--Any protected health care professional
who believes that the professional has been retaliated or
discriminated against in violation of section 144(b)(1) of the
Patients' Bill of Rights Act of 1999 may file with the
Secretary a complaint within 180 days of the date of the
alleged retaliation or discrimination.
``(2) Investigation.--The Secretary shall investigate such
complaints and shall determine if a violation of such section
has occurred and, if so, shall issue an order to ensure that
the protected health care professional does not suffer any loss
of position, pay, or benefits in relation to the plan, issuer,
or provider involved, as a result of the violation found by the
Secretary.
``(d) Conforming Regulations.--The Secretary may issue regulations
to coordinate the requirements on group health plans under this section
with the requirements imposed under the other provisions of this
title.''.
(b) Satisfaction of ERISA Claims Procedure Requirement.--Section
503 of the Employee Retirement Income Security Act of 1974 (29 U.S.C.
1133) is amended by inserting ``(a)'' after ``Sec. 503.'' and by adding
at the end the following new subsection:
``(b) In the case of a group health plan (as defined in section
733) compliance with the requirements of subtitle D (and section 115)
of title I of the Patients' Bill of Rights Act of 1999 in the case of a
claims denial shall be deemed compliance with subsection (a) with
respect to such claims denial.''.
(c) 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, as amended by the
Omnibus Consolidated and Emergency Supplemental Appropriations
Act, 1999 (Public Law 105-277), is amended by inserting after
the item relating to section 713 the following new item:
``Sec. 714. Patient protection standards.''.
(3) Section 502(b)(3) of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1132(b)(3)) is amended by
inserting ``(other than section 144(b))'' after ``part 7''.
SEC. 302. ERISA PREEMPTION NOT TO APPLY TO CERTAIN ACTIONS INVOLVING
HEALTH INSURANCE POLICYHOLDERS.
(a) In General.--Section 514 of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1144) is amended by adding at the end
the following subsection:
``(e) Preemption Not To Apply to Certain Actions Arising Out of
Provision of Health Benefits.--
``(1) In general.--Except as provided in this subsection,
nothing in this title shall be construed to invalidate, impair,
or supersede any cause of action brought by a plan participant
or beneficiary (or the estate of a plan participant or
beneficiary) under State law to recover damages resulting from
personal injury or for wrongful death against any person--
``(A) in connection with the provision of
insurance, administrative services, or medical services
by such person to or for a group health plan (as
defined in section 733), or
``(B) that arises out of the arrangement by such
person for the provision of such insurance,
administrative services, or medical services by other
persons.
``(2) Exception for employers and other plan sponsors.--
``(A) In general.--Subject to subparagraph (B),
paragraph (1) does not authorize--
``(i) any cause of action against an
employer or other plan sponsor maintaining the
group health plan or against an employee of
such an employer or sponsor acting within the
scope of employment, or
``(ii) a right of recovery or indemnity by
a person against an employer or other plan
sponsor (or such an employee) for damages
assessed against the person pursuant to a cause
of action under paragraph (1).
``(B) Special rule.--Subparagraph (A) shall not
preclude any cause of action described in paragraph (1)
against an employer or other plan sponsor (or against
an employee of such an employer or sponsor acting
within the scope of employment) if--
``(i) such action is based on the
employer's or other plan sponsor's (or
employee's) exercise of discretionary authority
to make a decision on a claim for benefits
covered under the plan or health insurance
coverage in the case at issue; and
``(ii) the exercise by such employer or
other plan sponsor (or employee of such
authority) resulted in personal injury or
wrongful death.
``(3) Construction.--Nothing in this subsection shall be
construed as permitting a cause of action under State law for
the failure to provide an item or service which is not covered
under the group health plan involved.
``(4) Personal injury defined.--For purposes of this
subsection, the term `personal injury' means a physical injury
and includes an injury arising out of the treatment (or failure
to treat) a mental illness or disease.''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to acts and omissions occurring on or after the date of the
enactment of this Act from which a cause of action arises.
TITLE IV--APPLICATION TO GROUP HEALTH PLANS UNDER THE INTERNAL REVENUE
CODE OF 1986
SEC. 401. 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 patient
freedom of choice.''; 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 title I
of the Patients' Bill of Rights Act of 1999 (as in effect as of the
date of the enactment of such Act), and such requirements shall be
deemed to be incorporated into this section.''.
TITLE V--EFFECTIVE DATES; COORDINATION IN IMPLEMENTATION
SEC. 501. EFFECTIVE DATES AND RELATED RULES.
(a) Group Health Coverage.--
(1) In general.--Subject to paragraph (2), the amendments
made by sections 201(a), 301, and 401 (and title I insofar as
it relates to such sections) shall apply with respect to group
health plans, and health insurance coverage offered in
connection with group health plans, for plan years beginning on
or after January 1, 2000 (in this section referred to as the
``general effective date'').
(2) Treatment of collective bargaining agreements.--In the
case of a group health plan maintained pursuant to 1 or more
collective bargaining agreements between employee
representatives and 1 or more employers ratified before the
date of enactment of this Act, the amendments made by sections
201(a), 301, and 401 (and title I insofar as it relates to such
sections) shall not apply to plan years beginning before the
later of--
(A) the date on which the last collective
bargaining agreements relating to the plan terminates
(determined without regard to any extension thereof
agreed to after the date of enactment of this Act), or
(B) the general effective date.
For purposes of subparagraph (A), any plan amendment made
pursuant to a collective bargaining agreement relating to the
plan which amends the plan solely to conform to any requirement
added by this Act shall not be treated as a termination of such
collective bargaining agreement.
(b) Individual Health Insurance Coverage.--The amendments made by
section 202 shall apply with respect to individual health insurance
coverage offered, sold, issued, renewed, in effect, or operated in the
individual market on or after the general effective date.
(c) Treatment of Religious Nonmedical Providers.--
(1) In general.--Nothing in this Act (or the amendments
made thereby) shall be construed to--
(A) restrict or limit the right of group health
plans, and of health insurance issuers offering health
insurance coverage, to include as providers religious
nonmedical providers;
(B) require such plans or issuers to--
(i) utilize medically based eligibility
standards or criteria in deciding provider
status of religious nonmedical providers;
(ii) use medical professionals or criteria
to decide patient access to religious
nonmedical providers;
(iii) utilize medical professionals or
criteria in making decisions in internal or
external appeals regarding coverage for care by
religious nonmedical providers; or
(iv) compel a participant or beneficiary to
undergo a medical examination or test as a
condition of receiving health insurance
coverage for treatment by a religious
nonmedical provider; or
(C) require such plans or issuers to exclude
religious nonmedical providers because they do not
provide medical or other required data, if such data is
inconsistent with the religious nonmedical treatment or
nursing care provided by the provider.
(2) Religious nonmedical provider.--For purposes of this
subsection, the term ``religious nonmedical provider'' means a
provider who provides no medical care but who provides only
religious nonmedical treatment or religious nonmedical nursing
care.
SEC. 502. COORDINATION IN IMPLEMENTATION.
Section 104(1) of Health Insurance Portability and Accountability
Act of 1996 is amended by striking ``this subtitle (and the amendments
made by this subtitle and section 401)'' and inserting ``the provisions
of part 7 of subtitle B of title I of the Employee Retirement Income
Security Act of 1974, the provisions of parts A and C of title XXVII of
the Public Health Service Act, chapter 100 of the Internal Revenue Code
of 1986, and title I of the Patients' Bill of Rights Act of 1999''.
Introduced in Senate
Introduced in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders, pursuant to the order of June 29, 1999. Calendar No. 200.
Measure laid before Senate. (consideration: CR S8209-8251)
Considered by Senate. (consideration: CR S8313-8313, S8335-8367)
Considered by Senate. (consideration: CR S8429-8501)
Considered by Senate. (consideration: CR S8535-8624)
Ordered held at the desk and not engrossed pending receipt of House companion measure.
Passed/agreed to in Senate: Passed Senate with an amendment by Yea-Nay Vote. 53-47. Record Vote No: 210.
Roll Call #210 (Senate)Passed Senate with an amendment by Yea-Nay Vote. 53-47. Record Vote No: 210.
Roll Call #210 (Senate)Senate ordered measure printed as passed with amendments of the Senate numbered.
Senate incorporated this measure in H.R. 2990 as an amendment. (consideration: CR S12654)
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Senate vitiated previous passage. (consideration: CR S12728)
Indefinitely postponed by Senate by Unanimous Consent. (consideration: CR S12728)