McCain/Edwards/Kennedy
Bipartisan Patient Protection Act of 2001 (S. 283/H.R.526)
Frist/Breaux/Jeffords
Bipartisan Patients' Bill of Rights Act of 2001 (S.887)
Scope
Covers about 190 million Americans.


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).

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).

Covers about 170 million Americans.

All Americans with group health insurance coverage and individual health insurance are protected by most provisions.


Does not cover Americans in self-insured state and local government health plans.

Enforcement follows the mechanism established in the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

State protections
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.

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.

Point of Service Option
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.

Exempts small employers (2-25 employees) or about 17 million Americans from this provision.

Emergency room care
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 coverage of emergency ambulance services.

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.

Requires coverage of emergency ambulance services.

Access to specialists
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.

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 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.

OB/GYN care
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 .

Requires OB/GYNs to seek same authorization as primary care provider for providing certain services.

Pediatric care
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.
Continuity of care
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.
Access to prescription drugs
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 include physicians and pharmacists when developing and reviewing their formulary.


Requires plans to disclose their formulary to physicians.

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.

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.

Clinical trials
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.

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.

Provides access to clinical trials approved and funded by the National Institutes of Health (NIH), Department of Defense, and Department of Veterans Affairs.

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.

Breast cancer treatment
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 notification of participant of this protection.

Plans must allow patients who have been diagnosed with cancer to visit and appropriately qualified
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.

Does not require notification of a participant of their protections under this provision.

Access to information
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.

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 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 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.

Gag clause
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.
Ban on provider discrimi-
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.
Ban on financial incentives
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 the Secretary of HHS to have IOM conduct a study regarding the affect of financial arrangements on medical care to patients.

Prompt payment of claims
Requires health plans to provide for prompt payment of claims with respect to covered benefits. No provision.
Whistle- blower protections
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.
Utilization review
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.

Prohibits plans from providing compensation to employees for encouraging denials.

No provision.
McCain/Edwards/Kennedy
Bipartisan Patient Protection Act of 2001 (S. 283/H.R.526)
Frist/Breaux/Jeffords
Bipartisan Patients' Bill of Rights Act of 2001 (S.887)
Internal appeal
Creates time-frames for initial coverage determinations:

-- 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

Creates time-frames for initial coverage determinations:

--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 .











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.

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.

External Review
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.

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.




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.

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.

External
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

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, 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.

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.

Civil Actions
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.
EXHAUSTION OF INDEPENDENT REVIEW PROCESS
A participant bringing an action is required to exhaust the appeal and independent review processes.

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.

An action may be instituted only if there has been a final determination by an independent medical reviewer reversing the plan's determination.

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.

Accountability
Cause of Action
Allow state causes of action for medically reviewable decisions result in personal injury or death.

Federal cause of action for contractual denials of claims, not based on medically reviewable decisions.

Does not lift current section 514 preemption of state laws.

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.

Damages
State court: State laws regarding caps prevail. 33 states have some form of cap on damages and they remain in effect.

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.

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.

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.

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

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