HR 719 IH
106th CONGRESS
1st Session
H. R. 719
To amend the Public Health Service Act and the Employee Retirement
Income Security Act of 1974 to protect consumers in managed care plans and other
health coverage.
IN THE HOUSE OF REPRESENTATIVES
February 11, 1999
Mr. GANSKE (for himself, Mrs. ROUKEMA, Mr. LEACH, Mr. WAMP, Mr. FORBES, Mr.
PETRI, Mr. SHAYS, Mr. HORN, Mr. FRELINGHUYSEN, Mr. FOLEY, and Mr. COOKSEY)
introduced the following bill; which was referred to the Committee on Commerce,
and in addition to the Committee on Education and the Workforce, for a period to
be subsequently determined by the Speaker, in each case for consideration of
such provisions as fall within the jurisdiction of the committee concerned
A BILL
To amend the Public Health Service Act and the Employee Retirement
Income Security Act of 1974 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 `Managed Care Reform 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--MANAGED CARE CONSUMER PROTECTIONS
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.
Subtitle B--Quality Assurance
Sec. 111. Standards for utilization review activities.
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. 192. Preemption; State flexibility; construction.
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--EFFECTIVE DATES; COORDINATION IN IMPLEMENTATION
Sec. 401. Effective dates.
Sec. 402. Coordination in implementation.
TITLE I--MANAGED CARE CONSUMER PROTECTIONS
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 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;
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.
(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 which do not provide benefits only
through participating health care providers and which provide for payment
for nonparticipating providers in an amount that is not less than the
amount paid to a participating provider for the same services.
(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 through payment of an
amount that is not less than the amount paid to a participating health care
provider for the same services. 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.
(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, the plan or issuer--
(A) 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
(B) may treat the ordering of other gynecological care by such a
participating physician 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) shall waive any
requirements of coverage relating to medical necessity or appropriateness
with respect to coverage of gynecological care so ordered.
(b) PEDIATRIC CARE- If a group health plan, or a health insurance issuer
in connection with the provision of health insurance coverage, requires or
providers for an enrollee to designate a participating primary care provider
for a child of such enrollee, the plan or issuer shall permit the enrollee to
designate a physician who specializes in pediatrics as the child's primary
care provider.
(1) SPECIALTY CARE FOR COVERED SERVICES-
(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 GATEKEEPER FOR TREATMENT OF ONGOING SPECIAL
CONDITIONS-
(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 care with respect to the condition. 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 FOR RELATED REFERRALS- 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)) with respect to the ongoing special
condition.
(C) ONGOING SPECIAL CONDITION DEFINED- In this paragraph, the term
`ongoing 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).
(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.
(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.
(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.
(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 or its medical manifestations.
(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.
(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.
(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).
(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 111, 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.
Subtitle B--Quality Assurance
SEC. 111. 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.
(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.
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 nonparticipating 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) 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.
(10) 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.
(11) 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 111, 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 as they relate to education, training, specialty
qualifications, and national accreditation.
(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.
(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.
SEC. 132. INTERNAL APPEALS OF ADVERSE DETERMINATIONS.
(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) An adverse determination under a utilization review program under
section 111.
(J) 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, enrollee, or provider 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.
(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.
(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 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 3 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 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), for which a
timely appeal is made either by the plan or issuer or by the participant,
beneficiary, or enrollee, or a representative of any of them. 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 $100; or
(B) the patient's life or health is jeopardized 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. In carrying out this subparagraph, the
determination of medical necessity shall be made under the process without
regard to the definition used by the plan or issuer. However, nothing in
this sentence shall be construed as providing for coverage of items and
services for which benefits are specifically excluded under the plan or
coverage.
(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 (directly or
through an authorized representative or representatives, any of whom may
be an attorney)--
(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 or, in the case of an appeal involving emergency
circumstances, as soon as possible in accordance with the medical
exigencies of the case, and in no event later than 24 hours) from the
date of completion of the filing of notice requesting an 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 (including any limitation on such 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.
(3) LIMITATION ON LIABILITY OF REVIEWERS- No qualified external appeal
entity having a contract with a plan or issuer under this part and no person
who is employed by, or who has a fiduciary relationship with, any such
entity or who furnishes professional services to such entity, shall be held
by reason of the performance of any duty, function, or activity required or
authorized pursuant to this section, to have violated any criminal law, or
to be civilly liable under any law of the United States or of any State (or
political subdivision thereof) if due care was exercised in the performance
of such duty, function, or activity and there was no actual malice or gross
misconduct in the performance of such duty, function, or activity.
(d) EXTERNAL APPEAL DETERMINATION BINDING ON PLAN-
(1) IN GENERAL- Subject to paragraph (2), the determination by an
external appeals entity under this section is binding on the plan (and
issuer, if any) involved in the determination.
(2) VACATION OR MODIFICATION OF DECISION- The determination by an
external appeals entity under this section may be vacated or modified by a
court under the same circumstances as the decision of an arbitrator may be
vacated or modified under sections 10 and 11 of title 9, United States
Code.
Subtitle E--Protecting the Doctor-Patient Relationship
SEC. 141. PROHIBITION OF INTERFERENCE WITH CERTAIN MEDICAL
COMMUNICATIONS.
(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 otherwise restrict a
covered health care professional (as defined in subsection (b)) from
advising such a participant, beneficiary, or enrollee who is a patient of
the professional about the health status of the individual or medical care
or treatment for the individual's condition or disease, regardless of
whether benefits for such care or treatment are provided under the plan or
coverage, if the professional is acting within the lawful scope of
practice.
(2) NULLIFICATION- Any contract provision or agreement that restricts or
prohibits medical communications in violation of paragraph (1) shall be null
and void.
(b) HEALTH CARE PROFESSIONAL DEFINED- For purposes of this section, the
term `health care professional' means a physician (as defined in section
1861(r) of the Social Security Act) or other health care professional if
coverage for the professional's services of the professional is provided under
the group health plan or health insurance coverage. Such term includes a
podiatrist, optometrist, chiropractor, psychologist, dentist, physician
assistant, physical or occupational therapist and
therapy assistant, speech-language pathologist, audiologist, registered or
licensed practical nurse (including nurse practitioner, clinical nurse
specialist, certified registered nurse anesthetist, and certified
nurse-midwife), licensed clinical social worker, registered respiratory
therapist, and certified respiratory therapy technician.
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;
(B) initiates, cooperates, or otherwise participates in an
investigation or proceeding by such an agency with respect to such care,
services, or conditions; or
(C) participates in an external appeals process under section
133.
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 or 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.
(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.
(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 the physician's professional judgment consistent
with generally accepted medical standards, in consultation with the patient,
to be medically appropriate following--
(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, lumpectomy, or lymph node dissection in a
hospital; or
(B) to stay in the hospital for a fixed period of time following a
mastectomy, lumpectomy, 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, lumpectomy, 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 2706 and 2751 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 license, and who, in the case of a physician,
is appropriately certified by a nationally recognized, peer reviewed
accrediting body 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 recommended or 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' mean, 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, or which requires
(in connection with any litigation against a health insurance issuer) that
the dispute be first, or simultaneously, considered through an alternative
dispute resolution system.
(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 and Labor shall issue such
regulations as may be necessary or appropriate to carry out this title, other
than section 151. 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 is amended by adding at the end the following new section:
`SEC. 2706. PATIENT PROTECTION STANDARDS.
`(a) IN GENERAL- Each group health plan shall comply with patient
protection requirements under title I of the Managed Care Reform 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 such Act (42 U.S.C.
300gg-21(b)(2)(A)) is amended by inserting `(other than section 2706)' after
`requirements of such subparts'.
SEC. 202. APPLICATION TO INDIVIDUAL HEALTH INSURANCE COVERAGE.
Part B of title XXVII of the Public Health Service Act is amended by
inserting after section 2751 the following new section:
`SEC. 2752. PATIENT PROTECTION STANDARDS.
`(a) IN GENERAL- Each health insurance issuer shall comply with patient
protection requirements under title I of the Managed Care Reform 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 is amended by adding at the
end the following new section:
`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 Managed
Care Reform 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 Managed Care Reform 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 141 (relating to prohibition of interference with certain
medical communications).
`(B) Section 142 (relating to prohibition against transfer of
indemnification or improper incentive arrangements).
`(C) Section 144 (relating to prohibition on retaliation).
`(D) 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
Managed Care Reform 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 Managed Care Reform 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
such Act (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 111) of title I of
the Managed Care Reform 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 such Act (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 such Act is amended by inserting
after the item relating to section 712 the following new item:
`Sec. 714. Patient protection standards.'.
(3) Section 502(b)(3) of such Act (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) NON-PREEMPTION OF CERTAIN CAUSES OF ACTION-
`(A) 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--
`(i) 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
`(ii) that arises out of the arrangement by such person for the
provision of such insurance, administrative services, or medical
services by other persons.
`(B) LIMITATION ON PUNITIVE DAMAGES- The plan or issuer is not liable
for any punitive, exemplary, or similar damages in the case of a cause of
action brought under subparagraph (A) if--
`(i) it relates to an externally appealable decision (as defined in
subsection (a)(2) of section 133 of the Managed Care Reform Act of
1999);
`(ii) an external appeal with respect to such decision was completed
under such section 133;
`(iii) in the case such external appeal was initiated by the plan or
issuer filing the request for the external appeal, the request was filed
on a timely basis before the date the action was brought or, if later,
within 30 days after the date the externally appealable decision was
made;
`(iv) the plan or issuer promptly followed the recommendation of the
qualified external appeal entity involved; and
`(v) such recommendation is not vacated under subsection (d)(3) of
such section based upon an action of the plan or issuer.
The provisions of this subparagraph supersede any State law or common
law to the contrary.
`(C) 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.
`(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 specifically excluded under the group health plan
involved.'.
(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--EFFECTIVE DATES; COORDINATION IN IMPLEMENTATION
SEC. 401. EFFECTIVE DATES.
(a) GROUP HEALTH COVERAGE-
(1) IN GENERAL- Subject to paragraph (2), the amendments made by
sections 201(a) and 301 (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 October 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) and 301 (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.
SEC. 402. COORDINATION IN IMPLEMENTATION.
The Secretary of Health and Human Services and the Secretary of Labor
shall ensure, through the execution of an interagency memorandum of
understanding among such Secretaries, that--
(1) regulations, rulings, and interpretations issued by such Secretaries
relating to the same matter over which two or more such Secretaries have
responsibility under title I (and the amendments made by titles II and III)
are administered so as to have the same effect at all times; and
(2) coordination of policies relating to enforcing the same requirements
through such Secretaries in order to have a coordinated enforcement strategy
that avoids duplication of enforcement efforts and assigns priorities in
enforcement.
END