Applies
to state and local government sponsored plans and church plans. Enforcement
follows the mechanism established in the Health Insurance Portability
and Accountability Act of 1996 (HIPAA). All Americans with group
health insurance coverage and individual health insurance are protected
by most provisions. Enforcement follows
the mechanism established in the Health Insurance Portability and Accountability
Act of 1996 (HIPAA).
New federal board shall
develop the criteria for evaluating state laws. The new board is also
responsible for annual congressional reports regarding state certifications
and the enforcement role of the federal government. Allows a state to challenge
a certification disapproval in United States district court.
Exempts small employers
(2-25 employees) or about 17 million Americans from this provision.
Requires coverage of
emergency ambulance services.
Requires coverage of
emergency ambulance services.
If a specialist is not
available in the plan the patient may seek treatment from a nonparticipating
specialist with the same cost requirements as the plan doctor.
Requires OB/GYNs to
seek same authorization as primary care provider for providing certain
services.
Requires plans to include
physicians and pharmacists when developing and reviewing their formulary.
Prohibits plans from
denying coverage of a drug or device on the basis that it is investigational
if it is included in the drug and device's authorized labeling under the
FDCA or PHSA.
Prohibits plans from
denying, limiting or imposing additional conditions of the coverage of
routine patient costs incurred while a patient is participating a clinical
trial.
Does not cover FDA trials. Requires administrative
negotiated rule-making process by Secretary of HHS for routine patient
costs. Implementation of this
section will not occur until 2004 when the standards are completed.
Requires notification
of participant of this protection. Plans must allow patients
who have been diagnosed with cancer to visit and appropriately qualified Does not require notification
of a participant of their protections under this provision.
For significant changes
in the plan, beneficiaries must be notified in advance of the effective
date of the change. Plans are given the flexibility to disclose information
electronically, when appropriate.
Requires Secretary of
HHS to conduct a study with the Institute of Medicine (IOM) regarding
health care professionals available to patients and barriers to sharing
information among professionals and recommendations for the disclosure
on health care professionals.
Requires the Secretary
of HHS to have IOM conduct a study regarding the affect of financial arrangements
on medical care to patients.
Prohibits plans from
providing compensation to employees for encouraging denials.
-- for expedited prior
authorization, as soon as possible in accordance with the "medical
exigencies" of the case, but in no case later than 72 hours -- for routine prior
authorizations, as soon as possible in accordance with the medical exigencies
of the case, but in no case later than 14 days after receipt of all necessary
information and 28 days after receipt of the claim -- for concurrent review,
as soon as possible in accordance with the medical exigencies of the case,
"with sufficient timeŠto allow for an appeal before the termination
or reduction [of coverage] takes effect" --for retrospective
determinations, as soon as possible in accordance with the medical exigencies
of the case, but no later than 30 days after receipt of all necessary
information or, if earlier, 60 days after receipt of the claim Patient can appeal a
plan's initial denial (prior-authorization) using the plan's internal
appeal process. This process must meet basic standards, including the
requirement that a physician who was not involved in the initial denial
review decisions involving medical judgment. Internal appeals decisions
should be made in a timely fashion according to medical exigencies of
the case. For normal cases, an insurer should respond within 14 days from
the date the plan receives information necessary to make a decision, but
in no case later than 28 days after the request for appeal is received.
If an insurer requests additional information from a patient or provider,
the patient or provider has five days from the request to submit such
information to the insurer. If a doctor feels the case requires expedited
consideration, an insurer should respond according to the medical exigencies
of the case, but not later than 72 hours. In the case of a reduction in
ongoing care, the insurer must provide the patient notice of the reduction
or termination of the care as soon as possible allowing enough time to
complete an external appeal before termination of ongoing care. would
take effect. If an insurer upholds the initial denial, the insurer must
promptly inform the patient of the reasons for the denial and the right
to an external appeal bene
--for expedited prior
authorization, 72 hours -- for routine prior
authorizations, 14 business days after receipt of all necessary information,
but no later than 28 business days -- for concurrent determinations,
24 hours -- for retrospective
determinations, 30 business days after receipt of all necessary information,
but no later than 60 business days . Requires the enrollee
and the treating professional to provide the plan or issuer with access
to information that is necessary to making an initial coverage determination
within 5 business days of making a claim for appeal. Requires providers to
substantiate the need for expedited initial coverage determinations.
Requires access to independent
medical review for denials for which the item or service would be a covered
benefit under the terms and conditions of the plan but for one of the
following determinations: (1) the denial is based on the fact that the
item or service is not medically necessary and appropriate; (2) the denial
is based on the fact that the item or service is experimental or investigational;
(3) the denial that the item or service is not covered requires an evaluation
of medical facts by a health care professional; or (4) the plan fails
to meet the applicable internal appeal. deadlines. Requires plans to permit
participants and beneficiaries access to independent medical review for
denials for which the item or service would be a covered benefit under
the terms and conditions of the plan but for one of the following determinations:
(1) the denial is based on the fact that the item or service is not medically
necessary and appropriate; (2) the denial is based on the fact that the
item or service is experimental or investigational; (3) the denial that
the item or service is not covered requires an evaluation of medical facts
by a health care professional; or (4) the plan fails to meet the applicable
internal appeal deadlines. Eligibility determinations,
cost-sharing decisions, decisions concerning exclusions/limitations and
decisions that do not involve medically reviewable decisions are not eligible
for external review. Total amount payable
under the plan or coverage for the item or service that was the subject
of such denial must exceed $100.
Requires external reviewers
to give no deference to the plan's determination or to the treating provider's
recommendation. Requires independent medical reviewers to make a new independent
determination to Reviewers are to take
into consideration "but not be bound by" the plan's definitions
of medically necessary and appropriate or experimental and investigational,
or other equivalent terms. If death or harm occurs
before the completion of the process they may begin instituting the action
but either party may request that the appeals process continue and be
completed, and that the results of this process be considered in court.
A beneficiary may seek
relief without exhausting all the remedies only if it can be demonstrated
by the preponderance of the evidence that the exhaustion of remedies would
cause irreparable harm to the health of the beneficiary and a subsequent
independent review reverses the decision of the plan.
Federal cause of action
for contractual denials of claims, not based on medically reviewable decisions.
Allows state causes
of action for liability or vicarious liability with respect to the delivery
of medical care but defines "delivery of medical care" so as
to exclude claims that relate to a plan's medical review or determination
of benefits. Creates a new federal
remedy for medically reviewable decisions that result in personal injury
or death but only if the external review rules on behalf of the patient.
If not, then the patient has no right of redress.
Federal court: Economic
and non-economic damages uncapped are available. A civil assessment of
up to $5 million payable to the claimant, may be awarded if the claimant
establishes by clear and convincing evidence that the alleged conduct
carried out by the defendant demonstrated bad faith and flagrant disregard
for the rights of the participant and was the proximate cause of the personal
injury or death.
If a contract decision
- such as whether a patient is a participant in the plan, results in injury
or death A participant can only seek redress in federal court for a civil
penalty of $100,000 that goes to the US Treasury not to the patient.
Bipartisan Patient Protection Act of 2001 (S. 283/H.R.526)
Bipartisan Patients' Bill of Rights Act of 2001 (S.887)
All Americans with group health insurance coverage and individual health
insurance are protected by all provisions (except point of Service access
does not apply to individual health insurance plans).
Covers
about 170 million Americans.
Does not cover Americans in self-insured state and local government health
plans.
Allows
states to maintain or develop their own patient protection laws, and empowers
the governors to certify that they are comparable to federal law. If the
state law is comparable to those at the federal level, the state law will
remain in effect. Certification process mirrors the S-Chip process. The
Secretary of HHS has 90 days to approve or reject the certification request.
Allows a state to challenge a certification disapproval in United States
district court.
Creates
a new federal board with 13 members appointed by the Secretary of HHS that
shall recommend the approval of a state's certification for the Secretary's
final approval unless there is no reasonable basis or evidence for such
approval.
Requires
plans to offer participants an out-of-network option. The increased costs
for such an option is the responsibility of the enrollee.
Requires
plans to offer participants an out-of-network option. The increased costs
for such an option would be paid for by the enrollee.
Requires
plans that cover emergency medical services to provide coverage for emergency
services, maintenance and the post stabilization of the patient without
prior authorization and without network limitations based on a prudent layperson
standard.
Requires
plans that provide coverage for emergency medical services to provide coverage
for emergency services, screening and stabilization of the patient without
prior authorization and without network limitations based on a prudent layperson
standard.
Provides
access to a specialist with adequate expertise including pediatric
expertise for patients with a condition or disease of sufficient seriousness
and complexity to require treatment by a specialist.
Requires
plans to provide timely access to an appropriate specialists when such care
is covered by the plan.
Plan determines if a patient can seek treatment from a specialist out
of network.
Allows
women to obtain gynecological and pregnancy related care from an OB/GYN
without requiring a referral or authorization by the primary care doctor.
Allows
women to obtain gynecological and pregnancy related care from an OB/GYN
.
Allows
a participant to designate a pediatrician as the primary care provider for
a child.
Similar
provision allowing a participant to designate a pediatrician as the primary
care provider for a child.
Requires
plans to provide coverage of a terminated medical provider to participants
who are engaged in treatment for a serious and complex condition. Continuing
coverage is for 90 days. Unique considerations provided for pregnant women
in their second trimester and terminally ill patients.
Similar
provision requiring plans to provide coverage of a terminated medical provider
to participants who are engaged in treatment for a serious and complex condition.
Continuing coverage is for 90 days. Unique considerations provided for pregnant
women in their second trimester and terminally ill patients.
Provides
participants with access to non-formulary medications when medically necessary
and appropriate. Cost sharing responsibility required by the plan remains
the same for the patient.
Requires plans to disclose their formulary to physicians.Provides
participants with access to non-formulary medications when medically necessary
and appropriate.
Requires plans to include physicians and pharmacists when developing and
reviewing their formulary.
Allows plans to deny access to specific drugs or class of drugs.
Provides
access to clinical trials approved and funded by the National Institutes
of Health (NIH), Department of Defense, Department of Veterans Affairs or
approved FDA clinical trials.
Provides
access to clinical trials approved and funded by the National Institutes
of Health (NIH), Department of Defense, and Department of Veterans Affairs.
Requires
coverage for an inpatient hospital stay for a period of time determined
medically necessary by the providing doctor for a patient following a mastectomy,
lumpectomy or lymph node dissection for the treatment of breast cancer.
physician for a second opinion.
Requires
coverage for an inpatient hospital stay for a period of time determined
medically necessary by the providing doctor for a patient following a mastectomy,
lumpectomy or lymph node dissection for the treatment of breast cancer.
Requires
plans to provide information to participants regarding plan benefits, cost-sharing,
access to physicians, preauthorization procedures, service, emergency care,
clinical trials, grievance and appeals process and provider compensation
methods. Upon request plans must provide qualifications of providers and
facilities; external appeals and the drug formulary.
Requires
plans to provide information to participants regarding plan benefits, cost-sharing,
access to physicians, preauthorization procedures, service, emergency care,
clinical trials, grievance and appeals process and provider compensation
methods. Upon request plans must provide qualifications of providers and
facilities; external appeals and the drug formulary.
Bans
plans from prohibiting or restricting medical providers from freely communicating
with their patients regarding their medical care & treatment.
Similar
provision. Bans plans from prohibiting or restricting medical providers
from freely communicating with their patients regarding their medical care
& treatment.
nation based on licensure
Prohibits
plans from discriminating against providers with respect to participation
or indemnification based solely on licensure or certification. Explicitly
allows plans to include providers only to the extent necessary to meet the
needs of enrollees and to maintain quality and control costs consistent
with the responsibilities of the plan or issuer.
Similar
provision prohibiting plans from discriminating against providers with respect
to participation or indemnification based solely on licensure or certification.
Explicitly allows plans to include providers only to the extent necessary
to meet the needs of enrollees and to maintain quality and control costs
consistent with the responsibilities of the plan or issuer.
Prohibits
health plans from using financial incentives to limit medically necessary
services. This provision does not prohibit the use of capitation
as a means of payment.
Does
not ban financial incentives.
Requires
health plans to provide for prompt payment of claims with respect to covered
benefits.
No
provision.
Plans
cannot punish providers who advocate on behalf of their patients, or who
assist their patients in the utilization review or appeals process.
No
provision.
Implements
procedures for monitoring or evaluating the use, coverage, clinical necessity,
appropriateness, efficacy, or efficiency of health care services. Utilization
review includes prospective, concurrent and retrospective review, as well
as second opinions, case management and discharge planning.
No
provision.
Bipartisan Patient Protection Act of 2001 (S. 283/H.R.526)
Bipartisan Patients' Bill of Rights Act of 2001 (S.887)
Creates
time-frames for initial coverage determinations:
Creates
time-frames for initial coverage determinations:
Establishes internal appeals process. Participant has 14 business days
after receipt of all necessary information, but no later than 28 business
days for concurrent determinations, for expedited prior authorization,
72 hours for routine prior authorizations, 24 hours for retrospective
determinations, 30 business days after receipt of all necessary information,
but no later than 60 business days.
A
patient who is denied care in the plan's internal review process has 180
days to appeal their case to an independent, external review body.
The entity's review decision is binding on the plan.
Eligibility determinations, cost-sharing decisions, decisions concerning
exclusions/limitations and decisions that do not involve medically reviewable
decisions are not eligible for external review.
Allows
plans to require participant or beneficiary to exhaust internal appeals
process and gives the participant or beneficiary 60 days to file request
for review.
Review
Selection &
Process
External
review entity must be independent of the health plan and must have sufficient
expertise and staffing to perform reviews within the time frames provided.
The medical reviewers must be appropriately licensed or credentialed and
must meet strict conflict of interest standards. The reviewers must be a
currently practicing physician
and in the case of a child, must have pediatric expertise. The medical reviewers
must use an objective standard of professional medical practice when making
a determination on the plan's denial
uphold, reverse or modify the plan denial based on the medical condition
of the patient and the valid, relevant scientific evidence and clinical
evidence, including peer-reviewed medical literature or findings and including
expert opinion.
Reviewers are to take into consideration "but not be bound by"
the plan's definitions of medically necessary and appropriate, or experimental
and investigational, or other substantially equivalent terms.
External
review entities are selected and paid for by the health plan.
Requires external reviewers to give no deference to the plan's determination
or to the treating provider's recommendation. Requires independent medical
reviewers to make a new independent determination to uphold or reverse
the plan denial based on the medical condition of the patient and the
valid, relevant scientific evidence and clinical evidence, including peer-reviewed
medical literature or findings and including expert consensus.
The
enrollee or provider may commence civil action against the plan to recover
the amount of the unpaid reimbursement if the plan fails to reimburse the
enrollee or any applicable providers for the services if the independent
medical reviewers find in favor of the enrollee. Includes civil penalties
on plan for failure to abide by review decision, and additional penalties
for patterns or practice of repeated violations (not to exceed the lesser
of 25% of the aggregate value of benefits not provided or $500,000).
The
participant or beneficiary or provider may commence civil action against
the plan to recover the amount of the unpaid reimbursement if the plan fails
to reimburse the participant or beneficiary or any applicable providers
for the services if the independent medical reviewers find in favor of the
enrollee. Allows the Secretary to assess a penalty of $10,000 against a
plan that fails to comply with any applicable timeframe in this section
and may assess an additional $10,000 penalty against the plan, payable to
the participant or beneficiary, if the plan ultimately fails to comply with
the decision.
A
participant bringing an action is required to exhaust the appeal and independent
review processes.
An
action may be instituted only if there has been a final determination by
an independent medical reviewer reversing the plan's determination.
Cause of Action
Allow
state causes of action for medically reviewable decisions result in personal
injury or death.
Does
not lift current section 514 preemption of state laws.
State
court: State laws regarding caps prevail. 33 states have some form of cap
on damages and they remain in effect.
Federal
court: Economic damages and non-economic damages capped at $500,000 (indexed
to inflation).
Contract Damages: No damages available to the participant for personal
injury or death caused by the denial of care based on a contractual eligibility
decision.
Click Links to see what sponsors have to say about
their legislation:
Senator McCain
- Senator Kennedy
- Senator Edwards
Senator
Frist - Senator Breaux - Senator
Jeffords
Congressman Norwood - Congressman Dingell - Congressman Ganske - Congressman Berry