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Backgrounder #1350 on Health Care

February 29, 2000

The Patient's Bill of Rights: A Prescription for Massive HealthRegulation

By

In the name of patient protection, Congress is poised to make the problems in America's current health care system even worse. The so-called Patients' Bill of Rights legislation now being considered by a House-Senate conference committee would impose massive new federal regulation on health care delivery and stir up new and expensive litigation.

The conferees will consider two versions of the Patients' Bill of Rights--one passed on July 15, 1999, by the Senate1 and another passed by the House on October 7, 1999.2 Supporters of the House version say its provisions are necessary to enable Americans enrolled in health maintenance organizations (HMOs) to sue their plans if they are denied promised benefits. But federal legislation is not needed for that purpose. HMOs and similar plans already can be sued in a variety of ways. Moreover, the House bill will have broader effects:

First, the legislation would lead to an explosion of costly litigation.
The House bill would broaden the types of damages that plan members could recover. Specifically, it permits states to treat disputes between plans and enrollees over coverage like tort lawsuits, with awards for pain and suffering, punitive damages, and non-economic damages. It also creates new legal rights for patients that would make it easier to sue.

Second, employers that provide health care benefits would be unable to escape the risk of devastating litigation.
The House bill would subject employers that provide health benefits to a new threat of being sued by their employees and being held liable for large awards of non-economic damages.

Third, Congress has insulated its own health plan and other government health plans from the legislation's complex provisions, terms, and resultant costs.
One of the telling curiosities of this legislation is that it would apply to Americans enrolled in private-sector health plans but not to anyone enrolled in programs under Congress's direct jurisdiction, most notably Medicare, Medicaid, veterans' health programs, and the Federal Employees Health Benefits Program (FEHBP).

Damaging Prognosis for Businesses and Families

The conferees and all Americans should seriously consider the likely effects of the Patients' Bill of Rights legislation on businesses, workers and their families, and the private-sector health insurance market. Specifically, it would lead to:

  • Rising costs. According to the Congressional Budget Office (CBO), the House bill would increase health insurance premiums by 4.1 percent.3 According to the Lewin Group, a prominent econometrics firm, every 1 percent increase in health care costs causes 300,000 persons to lose coverage.4 On the basis of the CBO analysis, more than 1.2 million Americans could be thrown out of employer-based coverage solely because of increases in costs.
  • Reduced coverage. The risk of large awards for damages resulting from the operation of plans they sponsor will cause thousands of employers to drop benefits from these plans. A survey of nearly 600 companies conducted by Hewitt Associates, a prominent benefits consulting firm, found that 36 percent said they would consider dropping health care coverage if their health plans were to be subjected to malpractice suits.5 Another survey of 400 company human resources directors, conducted by Harris Interactive Inc. for the American Association of Health Plans, found that if legislation were enacted making employers vulnerable to lawsuits and increasing the cost of insurance, then 38 percent "would be likely to stop providing coverage for some or all of their employees" and 57 percent "would be likely to stop doing so for some or all retirees."6 Based on the Harris Interactive survey, as many as 15.4 million Americans could lose their health coverage.7
  • A massive new federal regulatory structure. Both the House and Senate bills would deepen and broaden federal government regulation of health plans and health care delivery. Moreover, the legislation would prohibit plans--and their enrollees--from agreeing on the standards by which medical necessity is determined, and thus quash the right of private parties to enter into contracts of their own choosing.

A Better Policy

The heavy-handed regulatory policy embodied in both versions of the Patients' Bill of Rights, but most especially in the House version, would reduce the freedom of individuals and families to choose the terms of their own insurance coverage. Members of Congress backing these measures should consider that the real problems they want to solve can be addressed more effectively, and with far less damage to the delivery of health care and to patients, by strengthening consumers' ability to select their own health plans. This would put real power into the hands of working Americans without requiring the services of a lawyer.

CRAFTING A NEW FEDERAL REGULATORY STRUCTURE

Both the Senate and House versions of the Patients' Bill of Rights impose an intrusive federal regulatory structure on health plans and on the delivery of health care. The federal government would revive the regulatory role that Congress ended in 1986 when it repealed the National Health Planning and Resources Development Act.

Platform for Regulatory Expansion. The specific regulatory authority the bills introduce would be just the beginning of the federal bureaucracy's regulatory power grab. Inevitably, whatever regulatory authority is included in an enacted bill would be expanded over time. More important than the details of the bills, therefore, is the regulatory structure they would construct.8

Key Components of Regulatory Control

The House bill contains more regulatory requirements and would reach more plans than the Senate version of the Patients' Bill of Rights; but both versions would mean sweeping increases in federal regulation.

Consider the main regulatory components of the House bill.

Utilization Review.
Private health plans normally evaluate the utilization of medical services, treatments, and procedures. This process is essential for the cost-effective practice of medicine and helps restrain increases in insurance premiums. Under the House bill, however, managed care and fee-for-service plans would be able to conduct utilization review only as specified by the federal government.9

The term "utilization review" is defined more broadly in the bill than one might expect, and includes efforts to monitor or evaluate the "use or coverage, clinical necessity, appropriateness, efficacy, or efficiency of health care services, procedures, or settings...." This would include almost all the normal activities of fee-for-service plans, including determinations of whether a particular service is medically necessary in an individual case or generically.

A plan--including a fee-for-service plan--would be required to have written policies and procedures governing all aspects of its utilization review program, including clinical review criteria developed with input from a "range of appropriate actively practicing health care professionals." These criteria would have to be based on "valid clinical evidence" including "gender-specific criteria." Utilization review can be conducted only by "qualified health care professionals" who would "oversee" review decisions by "personnel who are qualified and have received appropriate training...." Different deadlines would be set for making UR determinations in cases of prior, concurrent, and retrospective review, with special rules for emergency services, maintenance care, and post-stabilization care. The failure to meet any of these deadlines would constitute the denial of a claim.

Internal Appeals.
The House bill requires plans to provide internal appeals of denials of coverage and specifies in precise detail the procedures to be followed.10 If the issue involves a medical judgment, the review must be made by a physician. In general, an internal appeal must be decided within 14 days, but an expedited appeal process is required where the normal time frame for a decision "could seriously jeopardize the life or health of the [patient or his] ability to regain maximum function."

External Appeals. The bill also requires private plans, including fee-for-service insurance, to provide external appeals of decisions made in the internal appeals process, and it stipulates in detail how those appeals are to be handled:11

  • Qualified Review Entities. A plan is required to contract with one or more "qualified external appeal entities" to conduct the appeal. To qualify, an entity dealing with a group health plan must be certified (and periodically re-certified) by the U.S. Department of Labor or a private organization certified by DOL. The entity also must have sufficient legal and other expertise, as well as sufficient staffing, and meet such other requirements as DOL or the U.S. Department of Health and Human Services may set. If the plan is an insurance plan, the external review entity with which it contracts must be certified (and periodically re-certified) by the state insurance commissioner (or other official) or, in the absence of state action, by HHS or a certified private agency. DOL and HHS (or the state agency) must assure that the plan's process for selecting its external appeals entity does not create an incentive for a "decision [to be made] in a biased manner." These agencies also must audit a sample of the entity's review decisions to ensure they have not been made in a "biased" manner.

The external review is conducted by a panel of at least three physicians or health care professionals who are practicing actively, hold a non-restricted license, and are "appropriately credentialed" in the same specialty or subspecialty that typically handles the medical condition or treatment at issue. Since different types of physicians often treat the same condition (e.g., medical oncologists, surgeons, and radiation oncologists treat cancer), it is not clear from the language of the bill which subspecialty would be required.

It also is unclear what the requirement that the health care professional be "appropriately credentialed" means. Physicians are not credentialed in a specialty, although they can earn certification from a specialty board and may have been credentialed by a hospital to use its facilities or, as required by Medicare, by a Medicare+Choice plan to participate in the plan.

  • Biased Independence. The appeal entity--and the "peers" it hires to conduct the reviews--must meet standards of independence that are complex as well as confused and one-sided. Compensation received by the entity or the peers it uses must be "reasonable." This means as a practical matter that compensation rates will be fixed by the two federal agencies with primary responsibility--the Department of Health and Human Services and the Department of Labor. Neither the peers nor the entity can have what is considered to be a conflict of interest, or have a "familial, financial, or professional relationship" with the insurer, the health plan, the plan sponsor (or any officer, director, or management employee of the plan or the insurer), the doctor who "provided" the treatment involved, the institution at which care "is provided," or with the manufacturer of a drug or medical supplier involved in the coverage decision. HHS and DOL can add other prohibited interests to the list.

A remarkable feature of the bill, however, is that there is no statutory prohibition against the peer reviewer's having a relationship with the patient involved. Since a coverage decision is likely to have much greater financial and personal impact on the patient than it would on a plan, a provider, or the supplier, this is surprising. The peer reviewer presumably could not own stock in the drug company whose drug was at issue or have privileges at the hospital where the care at issue would be provided, but could, it seems, be married to the claimant.

The bill also requires that there be no "apparent" conflict of interest (as determined by DOL or HHS). This open-ended standard, combined with the authority of HHS to issue regulations to list other prohibited relationships, gives the government extraordinary power to prohibit additional relationships--although the bill apparently contemplates that this would apply only on the provider-supplier side of the equation.

  • Appeal Procedures. The external review process must be "fair," but the bill does not specify what that vague term means. It does not specify, for instance, whether witnesses may be called, whether they may be cross-examined, whether parties may conduct "discovery," whether testimony will be taken under oath, and whether transcripts of the proceedings must be made. All of these matters will be dictated by HHS and DOL.

The external review must be de novo. In common legal parlance, this means that the appeal starts from scratch as if the previous proceeding (here the internal review) had not taken place. However, the bill also requires the external review entity to "consider" the decision made by the internal reviewer. It does not say how much weight should be given to that decision. The standard of review is unclear. HHS and DOL will decide how the appeal is to be conducted. One can only imagine the intricacy these regulations may entail: HHS and DOL as lawgivers.

  • The Medical Necessity Quandary. The only standard for review is that the external review entity must determine whether a denial of coverage "is in accordance with the medical needs of the patient involved (as determined by the entity)...." In making this determination, the external review body is explicitly authorized to disregard any provisions in the plan defining what is medically necessary: "In making such determination, the external appeal entity shall consider (but not be bound by) any language in the plan or coverage document relating to the definitions of the terms medical necessity, medically necessary or appropriate...."12

This constitutes a remarkable intrusion by the federal government into private arrangements. The final determination on what is covered by a plan is to be made by a peer review entity that is certified and regulated by--and answerable to--the federal government. This requirement would subject private health plans (and employers that pay for the plans) to an incalculable contingent obligation.

Moreover, "medical necessity" is a phrase that has no accepted meaning. It may sound like a standard, but it is not. The factors that go into determining what treatment will be provided in a particular case often are too subjective and too variable to be reduced to such a conclusory term.

Many health policy experts think highly of "outcomes" data--studies of the effectiveness of treatments in curing patients or in alleviating the conditions of disease. But while outcomes studies can provide valuable guidance, they are percentages based on the cases included in the study. By definition, the derived averages cannot match the characteristics of a particular patient. And even if the outcomes data were somehow to precisely match the characteristics of the patient, they do not automatically answer what is medically necessary. Is a treatment that has a 5 percent chance of success medically necessary? And what is success? Prolonging life for three months? There is no scientific answer to such questions. But, of course, these are precisely the kinds of questions that doctors, patients, and third-party payers must face.

The legislation would punt these crucial questions to the subjective consideration of external reviewers. The bill will turn the determination of what is covered over to government-controlled external reviewers who are directed to make their decisions regardless of what the private health plan and its enrollees agree upon. As a result, it will be virtually impossible for insurers to develop different products with different coverage at different prices. This development will deprive Americans of the ability to make their own choices on the tradeoff between price and level of coverage.

One-Sided Judicial Review.
Members of a plan who are dissatisfied with the external review body's decision can appeal to court, but the plan may not be able to. The bill provides that the determination of the external review body is "binding on the plan."13 It then states that "Nothing in this subtitle shall be construed as altering or eliminating any cause of action or legal rights or remedies of participants, beneficiaries, enrollees, and others under State or Federal law...including the right to file judicial actions to enforce rights."14 Thus, a decision of the external reviewer is "binding" on the plan, but the protection of rights does not guarantee judicial review for plans (unless the word "others" is interpreted to include the plan or other law is deemed to protect the plan's right to appeal).

Federal Penalties and Purges.
Instead of permitting plans to appeal to court, the bill would penalize them if they do not comply with the decision of the external reviewers.15 Any person who "causes such refusal" is liable to the patient for up to $1,000 a day. HHS or DOL would be able to assess a civil penalty (a maximum of $500,000) against any plan official who has demonstrated a pattern or practice of refusing to carry out the coverage decisions of the external review entities. And the government could ask the court to remove that official from office and bar him from any other "involvement" with that plan (and perhaps any other plan).16

Federally Established Grievance Process.
Each plan is required to establish a process for receiving and resolving the grievances of plan enrollees and providers on matters other than claims for benefits. This requirement would apply to fee-for-service plans as well as to managed care plans.17

Federally Required Point of Service (POS).
The bill attempts to regulate the supply of insurance products. Any insurer who offers a network plan to an employer group also would be required to offer (or arrange for) a plan that covers services that are not furnished through the network, unless some other plan is offering the group such a product.18 Consequently, an HMO that does not arrange for a POS product could, depending on the actions of others, be barred by law from selling to employer groups.

While the probable congressional intent behind this provision is to increase choice by mandating the supply of more alternatives for employer groups, it could have the opposite effect. For example, an HMO might not be set up to offer POS plans and thus would not be able to sell in markets in which others were not offering a POS plan.

Federally Directed Delivery of Care.
The bill subjects the delivery of care to federal regulation in a number of ways. For instance, if a plan provides for designation of a primary care provider, the member must be able to designate any such provider who is "available to accept" him.19

The plan also must "permit" each member to "receive medically necessary or appropriate specialty care, pursuant to appropriate referral procedures, from any qualified participating professional who is available."20 Although the bill states that this requirement is subject to limits on the choice of specialists that are made clear to the plan members, the ability of the plan to provide for limits on the choice of specialists is explicitly overridden by another requirement21 that the plan provide a referral to a specialist if the patient "has a condition or disease of sufficient seriousness and complexity to require treatment by a specialist."22

This statutory requirement is entirely circular: Specialists must be provided when they are needed. The bill defines "specialist" as a provider or institution that has "adequate expertise through appropriate training and experience...to provide high quality care in treating the condition."23 The plan must provide a referral to a non-participating provider (at no extra cost to the patient) if it does not have an "appropriate specialist that is available and accessible" to treat the patient.24

If a patient has an "ongoing special condition" (which includes a "degenerative" or "disabling" condition), he may require the plan to refer him to a specialist to coordinate his care where it "would most appropriately be coordinated by such a specialist." The bill, in addition, imposes specific requirements for standing referrals for patients who require "ongoing care" (it is unclear whether this is a different standard from having an "ongoing special condition").25 It also contains special rules for access to obstetrical, gynecological, and pediatric providers.26

A plan member with an "emergency medical condition," moreover, would be entitled to go to any emergency room (not just one participating in the plan's network).27 If he goes to a non-participating hospital, meaning a hospital that does not have a reimbursement agreement with the plan, he cannot be charged more than if he had gone to a participating hospital, even if the participating hospital is equally convenient. In addition, the patient has the right to receive "maintenance care" and "post-stabilization care" at that or apparently any other non-participating hospital at no extra cost, and the plan must comply with "guidelines" issued by the Medicare bureaucracy.

The bill also requires a plan to provide "continuity of care" for specified periods of time.28 If a physician is treating a plan member who has an "ongoing special condition" and the provider is no longer participating in the plan (for reasons other than fraud or failure to meet the plan's quality standards), the plan must continue to provide coverage as if the physician were still participating. Beyond this, if the contract between a group health plan and an insurer is terminated, the patient can continue to receive coverage for treatment by the provider who had been treating him under the plan. In this circumstance, the insurer will not be receiving premiums on behalf of the patient, but will be obligated to continue to pay for care for the patient.

Federal Prescription for Drugs.
If a plan uses a formulary for prescription drugs, the bill specifies how the plan must develop and apply the formulary.29 The plan must ensure that the participating physicians are involved in developing the formulary and that the formulary provides for exceptions when a non-formulary alternative is "medically indicated."

Federal Requirements for Patient Care in Clinical Trials.
Plans "may not deny" their enrollees' participation in clinical trials and must pay routine patient costs for services performed in connection with the trial.30 This requirement applies to fee-for-service as well as managed care plans. HHS or DOL would determine what costs the sponsor of the trial must pay and what the plan would be responsible for paying. That itself would involve a complex process.

To be eligible for this protection, the patient must have a serious or life-threatening illness "for which no standard treatment is effective." What is "standard" and what is "effective" are not defined. The trial must offer "meaningful potential for significant clinical benefit for the individual." Not only are these terms also undefined, but they also call into question whether the patient could be a member of a control group.

The requirement applies only to clinical trials approved and funded (although the bill does not say to what extent) by the National Institutes of Health (or one of its cooperative groups or centers), the Department of Veterans Affairs, or the Department of Defense. It does not apply to trials sponsored by pharmaceutical companies to test the safety and efficacy of new drugs for approval by the Food and Drug Administration.

Federal Information Requirements.
The House legislation would require plans to give specified types of information to enrollees in the stated circumstances. The requirement applies to fee-for-service plans, but a number of the items may not mesh with the way such plans operate.

The section of the bill detailing these requirements is more than seven pages long.31 Among the items a plan must describe are the "service area" of the plan; the "number, mix, and distribution of providers under the plan"; whether a participating provider is available to accept new patients; how the plan "addresses the needs of [members] who do not speak English or who have other special communications needs in accessing providers"; the "appropriate use" of emergency services, including the 911 system; and the insurer's loss ratio (as defined by HHS). Additional items of information must be made available upon request, including a description of the plan's utilization review program, the method of physician compensation it uses, and a description of the "credentials" (the ambiguity and inappropriate use of this term was discussed above) of participating providers.

Federal Control of the Physician-Plan Relationship.
The House bill would allow the federal government to regulate the relationship between the plan (including fee-for-service coverage) and participating physicians in several ways. For instance, it would void any provision of a contract between a plan and a health care provider that restricts the provider's ability to advise a patient about his health status or medical treatment--as long as the professional is acting within the lawful scope of his practice.32 The federal government would be able to review every contract and consider whether any provision has the effect of restricting a doctor's ability to give advice.

The bill would prohibit a plan from discriminating, with respect to participation by providers or payments to them, on the basis of license or certification under state law.33 It is unclear whether this language would prevent the plan, for example, from making a blanket determination to pay registered nurses more than practical nurses or from paying board-certified physicians more than others. It also is unclear whether it would prohibit plans from requiring that its physicians (or those in certain categories) be board certified. And it is unclear as to what extent the plans would be able to take advantage of the flexibility allowed to establish "any measure designed to maintain quality and control costs consistent with the responsibilities of the plan." HHS and DOL will decide.

The bill would prohibit retaliation by a plan against anyone for participating in a plan's utilization review, grievance, or appeal proceeding.34 It would further prohibit retaliation against a "protected health care professional" for disclosing information about care to an "appropriate" public or private regulatory or private accreditation agency if he acted in "good faith" and followed "reasonable" internal procedures of the plan or provider before making the external disclosure. The requirement of prior internal disclosure would not apply if the disclosure relates to an "imminent hazard of loss of life or serous injury to a patient," is made to an accreditation body, or is in response to a governmental investigative inquiry. On the other hand, the protection for external disclosure would not apply if it would violate law or impair "confidentiality of communications" provided by law.

The bill adopts the Medicare rules on incentive plans for physician compensation.35 Those rules prohibit payments, directly or indirectly, that would be an inducement to reduce or limit medically necessary services. They limit the extent to which the plan can put the physician at financial risk for the cost of care through capitation arrangements, withholds, or bonuses. HHS and DOL would thus have final authority over the validity of many managed care plans' compensation arrangements with their physicians.

An Attack on Fee-For-Service Coverage

Most of the House bill's requirements, as noted above, apply to fee-for-service coverage as well as to managed care plans. But some do not, which makes it necessary to define fee-for-service coverage.

The House bill would create a federal definition of fee-for-service coverage. Under this bill, fee-for-service coverage would (1) reimburse providers "on the basis of a rate that is determined by the plan...on a fee-for-service basis without placing the provider at financial risk"; (2) not vary a provider's reimbursement "based on an agreement to contract terms and conditions or the utilization of health care item or services relating to such
provider"; (3) pay all providers who are lawfully authorized to provide the service and agree to the terms set by the plan; and (4) not require prior authorization before providing coverage. The failure to meet any one of these specified conditions would disqualify a plan as a fee-for-service plan.36

To fall within this statutory definition, a plan could not exclude providers on the basis that they had been prone to over-prescribe treatments. Nor, it seems, could it exclude them on the basis of character or competence, so long as they had a license to practice. And doctors or other providers could not negotiate rates with the plan; hospitals and physicians could only choose between accepting and rejecting rates offered by the plan on a take-it-or-leave it basis.

By defining it, the federal government would be regulating how the fee-for-service sector operates. Plans, doctors, and hospitals may find that the definition unduly restricts their activities, and fee-for-service plans may not continue to qualify as such.

On the other hand, there may not be much advantage in qualifying, and plans may not attempt to meet the definition of fee-for-service. The only benefit of being termed a fee-for-service plan is that the plan would not have to offer a point-of-service option and would not have to meet the access requirements in the bill.37 A plan might find that this exception is not worth very much. Fee-for-service plans by definition would be POS plans. And since they typically do not limit referrals to specialists, they would appear to meet the access provisions without having to change the way they operated. Since a fee-for-service plan already meets the legislative requirements that it would be exempt from, it may not want to give up the flexibility in other areas that would be necessary to qualify.

At the same time, even if it did qualify as a fee-for-service plan, it would be subject to the other requirements of the bill that could make it impossible to operate. The provisions detailing how utilization reviews, as broadly defined by the bill, are to be conducted, the prescriptive requirements for the internal and external review process, the grievance process requirements, and the requirements on information that must be given to enrollees would not fit fee-for-service operations easily.

In short, a complicated congressional scheme intended to restrict the operations of managed care plans and to preserve more of the attitudes and operations of fee-for-service coverage in health care may instead result in the destruction of fee-for-service health care.

Fuzzy Boundaries Between State and Federal Regulation.
The House language exacerbates the confusion over what types of state regulation affecting the different types of employer plans would be preempted. One paragraph says that the regulatory sections of the House bill do not "affect or modify" the current Employment Retirement Income Security Act (ERISA) preemption.38 Yet another paragraph applies a different standard for health insurance companies: States may impose any requirement if it applies "solely" to insurers, "except to the extent that such standard or requirement prevents the application of a requirement of this title [the regulatory portion of the bill]."39 If a state requires plans to conduct utilization reviews in a different manner, the question would be whether this review "prevented" an insurer from complying with the provisions of the House bill. Moreover, the provision introducing the federal standard for insurers would be "subject to" the paragraph providing that the bill does not change the existing ERISA preemption. With respect to insurers, therefore, it is not clear whether the standard for insurers would remain as it is today or change.

Summarizing the Regulatory System

The Patients' Bill of Rights, in either the House or the Senate version, would create a new regulatory platform and impose hundreds of regulatory requirements and conditions on private-sector plans. To summarize the nature of this regulation:

  • Policy goals would be turned into regulatory requirements. Both bills would turn laudable goals (such as appropriate access to specialists, good information, and fair coverage decisions) into regulatory requirements. And they would do so without balancing other important considerations, such as the cost of reaching the goals and whether the plans and their enrollees should be free to develop different balances and different ways of reaching the desired result. Freedom, diversity, and flexibility are thus ignored and subordinated to a politically driven and bureaucratically enforced view of what is appropriate.

  • The new rules would be rigid. The legislation standardizes the definitions and goals and makes these a matter of governmental direction rather than based on plan and member agreement. Whether a patient should be referred to a specialist, for example, would be determined by government regulation. Referrals would have to comply with a rulebook, which of necessity would be inflexible and incapable of dealing with the variables and ambiguities of real life.

  • Statutory ambiguities would expand bureaucratic control. The regulatory nature of the legislation would be worrisome enough if the standards were clear. But they are not. Most of the required conduct is phrased in ambiguous terms, such as "appropriate," "sufficient," "available," "valid," "qualified," "fair," "medically necessary," "medical needs," "professionally recognized standards," and "professional consensus." This means the government will have to issue detailed regulations attempting to define these terms, and plans and providers will have to expend great effort and substantial resources attempting to comply. Then the
    federal agencies will attempt--by directives, instructions, press releases, letters, and other informal mechanisms--to define the undefinable.

This complex regulatory process will increase plan costs. It is also likely to reduce the number of plans willing to participate in the market.

Ironically, while imposing all of this red tape, the House bill piously declares that there is already too much regulation in the health care field:

Congress finds that continually increasing and complex Government regulation of the health care delivery system has proven ineffective in restraining costs and is itself expensive and counterproductive in fulfilling its purposes and detrimental to the care of patients.40

More Support for Lawsuits

The House bill encourages the expansion of private litigation against health plans and employers. Each regulatory requirement would create a legal right that could itself be a cause of action,41 or that could be used as evidence of the applicable standard to support a claim for damages for an adverse outcome.

The House bill provides that "a failure to provide benefits (including items and services) required to be provided under" the regulatory sections of the bill would constitute a denial of a claim.42 If a patient suffers an adverse event in the course of receiving health care, he can readily allege some violation of the bill's requirements and argue that the violation of this standard caused his injury. He would be able to sue for damages resulting from the violation (even if the action would not otherwise have been negligence).

For example, a health plan could be sued on the allegation that it did not "make or provide for a referral to a specialist" quickly enough or that the specialist consulted did not have "adequate expertise."43 This of course would be judged in hindsight by a jury deciding between a faceless corporation--an allegedly malodorous insurance company at that--and a sympathetic patient or his family who suffered a bad outcome.

The sponsors of the bill attempted to limit the ability of patients to bring private actions. The provision, however, appears to be self-contradictory.44 In any event, it applies only to actions brought "under" ERISA, and not to actions brought under state law. Since the bill would repeal the current ERISA preemption of state law, suits could be brought against plans and employers under state law. Nothing in the bill prevents the use of violations of the obligations it imposes to support lawsuits for damages that result from adverse events in the course of health care.

EXPANDING EXPENSIVE LITIGATION

Sponsors of the legislation say that the bill is necessary to enable members of HMOs to sue their plans. This nicely draws attention from the formidable regulatory features of the House and Senate bills. Yet even with respect to the litigation provisions in the House bill, supporters misstate the need for the bill.

Members of HMOs can already sue their plan in a variety of circumstances under current law. To be sure, Congress should debate the extent and type of damages that patients should be able to recover from an ERISA plan for denial of coverage in violation of its terms. But this is a far different issue from the one posed--the need to sue--that is being broadly presented to the public.

The Role of ERISA

The federal government traditionally has not regulated health insurance; regulation has been largely confined to the states. In 1974, however, Congress enacted ERISA, which imposed federal regulation on employer benefit plans. Although the focus of ERISA was on pension plans, the Supreme Court has interpreted ERISA to apply to health coverage provided by the employer. Because it provides federal regulation of the operation of employer plans, ERISA preempts conflicting state laws that relate to benefit plans--not only HMOs, but also fee-for-service plans and other types of arrangement. State law encompasses statutes, administrative regulations, and--most important for the purpose of this analysis--common law applied (and in some cases created) by the courts of the state.

ERISA, however, does not preempt non-conflicting state laws that relate to health insurance. If an HMO (or any other type of plan) is considered an insurance plan, it is subject to state law, and it can be sued under state law. Nor does ERISA prevent enrollees of plans from suing their doctor or hospital for malpractice under state law. It does not prevent plans from being held liable for their own negligence in delivering care or for the
malpractice of providers where state law provides vicarious liability, for instance, if the negligent doctor is employed or controlled by the plan.45

  • Coverage Disputes. The main issue with respect to the effect of the ERISA preemption has arisen in suits brought against employer plans for denial of coverage. The employer, or a third-party administrator managing the plan, may reject coverage because it determines that the service is not medically necessary in the particular circumstance. This in effect raises a contract question: Does the plan that the employer provides to the employee cover the service at issue? The plan may be fee-for-service, a preferred provider organization (PPO), an HMO, or some other form of managed care. If the plan denies coverage, the plan member can pay for the treatment and then sue the plan. Indeed, contract law may require the patient to mitigate damages by doing so.

As a matter of common sense, a patient typically would prefer to get the treatment that he feels is necessary even if he must pay for it and then seek reimbursement from the plan. This would be preferable to forgoing treatment and suing for damages alleged to be caused by the lack of treatment. There are cases, of course, where it is not financially possible for a patient to pay for the disputed treatment. But in other cases, the issue involves a test or an extra day in the hospital; people with employer-provided insurance who by definition are working (the ERISA preemption only applies to employer-provided coverage) are likely to be able to finance the cost of these services while appealing the denial of coverage.

ERISA provides that if a plan denies coverage, the plan member may sue "to recover benefits due to him under the terms of" the plan and for equitable relief. It preempts any action for denial of coverage under state law, not only for self-funded plans, but also for all employer plans.

  • No Consequential Damages. When the employee sues for denial of coverage, therefore, he can recover the benefit due him, but he cannot sue for the kinds of consequential damages that could be awarded in a tort case (like a claim for malpractice against a doctor). In tort cases, state laws provide awards for non-economic consequences of the injury, such as pain and suffering, mental distress, and hedonic damages (loss of the pleasure of life). In addition, state law may permit the plaintiff to recover punitive damages for the express purpose of punishing a provider whose conduct is found by the jury to be outrageous. ERISA prevents the courts from awarding these kinds of damages for denial of coverage. ERISA prevents contract-like disputes over the terms of coverage from being turned into tort-like suits for recovery not merely of the benefit, but of non-economic consequential damages and punitive damages as well.

Eliminating the ERISA Preemption

The House bill would remove the preemption that has required coverage disputes to be resolved under ERISA rather than under state law. It would not itself create law that provides for non-economic damages in coverage disputes, but would defer to whatever the state law is. It would permit, but not require, state legislatures and state courts to turn coverage disputes into malpractice-like lawsuits.

Although on its face this appears to be simply a matter of letting state law apply, in reality enactment of the House bill would set in motion a dynamic and mutually iterative process. If Congress enacts and the President signs this legislation, it would send a signal to plaintiffs' lawyers, state legislatures, and state courts that the federal government is sympathetic to the approach of treating coverage disputes as torts.46 It will encourage the legislatures to enact, and the state courts to discover, such laws.

The Enormous Risk Employers Would Face.
The House bill gives the states maximum discretion by providing that ERISA will not affect any action that can be brought under state law against "any person" for personal injury or wrongful death "in connection with" the provision of--or that "arises out of the arrangement for" the provision of--"insurance, administrative services, or medical services" by that person or others.47 Thus, the employer himself, as well as the plan, could be sued for damages resulting from denial of coverage.

The bill, however, purports to protect the employer from suit. It provides that the repeal of the ERISA preemption does not authorize a claim against a plan or an employer sponsoring the plan unless the lawsuit is based on its "exercise...of discretionary authority to make a decision on a claim for benefits...in the case at issue."48 Thus, the employer ostensibly can avoid litigation by turning over administration of the plan to a third party and playing no role in its management.

But even if employers were willing to take this hands-off approach to their plans, they are likely not to be protected by this provision. It will be interpreted and applied by the courts, and courts that have been most receptive to causes of action for non-economic damages will be the most aggressive in finding ways around the protection provided by the bill. Employers simply cannot count on the courts to protect them from suit.

It is impossible to predict what interpretative gloss the courts will put on this provision, but one can foresee possible avenues they might take. They could, for instance, hold that if an employer exercised discretionary authority in one instance, he could be liable even where he did not make a coverage decision in the case at issue; the failure to become involved where he could have acted to direct that the service be covered, under this line of thinking, would itself be an exercise of discretionary authority. Or a court might find that the exercise of discretionary authority by a third-party plan administrator was attributable to the employer on the theory that the administrator was the employer's agent and that the employer could be held directly liable for the actions of his agent.

Employers who sponsor plans for their employees, therefore, would put all their assets (not merely those in the plan) at risk. They would be subject to liability for punitive and other non-economic damages, depending on state law and the courts' interpretation of the scope and meaning of the reservation of ERISA preemption in the Patients' Bill of Rights.

The employer's risk, however, is not limited to being held liable. Even if an employer ultimately avoids liability by demonstrating that he did not exercise discretionary authority, he will be embroiled in litigation. He must prove this defense. The bill states that it does not authorize suits in the stated circumstances, but that does not mean that employers will not be sued. Employers will have to establish that they qualify for the continued preemption against state law because they did not exercise discretionary authority--as that phrase is ultimately (and no doubt variously) interpreted by the courts. They will have to undergo the expense, distraction, and harassment of litigation in order to do so.

This process will include intrusive and expensive "discovery" about the employer's operations in connection with the plan. The plaintiff could obtain the employer's and the plan administrator's documents and ask questions at deposition concerning communications between them. He could conduct this discovery in an effort to prove the exercise of discretion or the existence of an agency relationship or to establish whatever other theory is invoked to avoid the protection included in the bill. This means that employee records maintained by the employer and the plan administrator would be examined. They are likely to be exposed publicly.

Meaningless Exception for Punitive Damages.
The congressional sponsors of the bill purport also to reserve some ERISA preemption with respect to the award of punitive damages under state law. The bill prohibits the award of punitive damages if the plan complies with the ruling of an external review entity that a treatment is covered.49 But this apparent protection is of no value. The precise terms of the protection prevent it from applying in the only circumstances in which it would be useful:

  • It is limited. The protection does not apply to the many other theories on which non-economic damages can be awarded--such as pain and suffering or mental distress.

  • It has little value. Even with regard to punitive damages, the protection has little value; it does not apply if the patient has died and the family brings a wrongful death action.

  • It is spurious. Plans and employers will not be sued in the one circumstance in which the limitation for punitive damages would be applicable. Since, as noted above, it appears that a plan cannot appeal a ruling of an external review agency finding coverage and since plan personnel who do not follow it can be fined, the plans will follow the decision of the external review body. The patient will have no complaint, and the plan will not be sued.

  • It is trumped by judicial review. If the patient loses before the external appeals entity, appeals to court, and then wins, the protection would not be applicable by its own terms: There would have been no determination of coverage by the appeals entity that the plan could follow. But the fact that it does not apply again may be immaterial. If the court finds coverage, the plan will carry out the court order and provide the services, and the patient will have no complaint.

  • It does not apply where there is injury. This protection, finally, does not apply if the patient does not go through the appeals process.50 If he suffers an adverse outcome and can prove that the bad result was "caused" by the denial of coverage, there is nothing in the bill that would prevent him from suing for damages under state law, and the protection against punitive damages would not be applicable. The plan would not have followed the ruling of an outside review agency because there was none and it did not have the chance to do so. Employers and plans, therefore, will surely be at risk of liability for punitive damages awarded at the largely unbridled discretion of a jury.

SPECIAL TREATMENT FOR FEDERAL PROGRAMS

The House bill is based on the assumption that suits for punitive and non-economic damages are necessary to ensure that employer-provided plans act appropriately. Congress would make these "rights" available (depending on state law) to employees who are members of employer-provided health plans. But Congress would not do so for the federal government's own employees, including its own staff members and the millions of Americans enrolled in other federal government programs, such as Medicare and Medicaid recipients and veterans. Senior House leaders decided to maintain this exclusion during debate on their version of the bill.51

For example, the statute under which the Federal Employees Health Benefits Program is made available for federal workers is based upon ERISA and prohibits lawsuits under state law against insurers who cover federal workers. The federal employee who is denied coverage can collect the cost of the denied benefits, but he cannot recover the consequential damages that the Patients' Bill of Rights would make possible for private-sector employees under state law.52 Similarly, if Medicare determines that a treatment is not medically necessary, the beneficiary can obtain administrative and, if necessary, judicial review. But if it is established that Medicare wrongfully denied coverage, it is required only to pay for the treatment. A beneficiary covered by traditional Medicare cannot recover punitive and other non-economic damages under state law if Medicare wrongfully denies a claim for coverage.

If Congress wants to make a policy decision to subject plans sponsored by private-sector employers to lawsuits under state law, it is not clear why the same policy should not apply to federal workers and beneficiaries of federal health programs, including in particular Medicare beneficiaries who are members of private managed care plans under Medicare+Choice (Part C) and federal workers who join HMOs. Presumably, these millions of patients would welcome the supposed benefit of larger damage awards for denied coverage as much as patients in private-sector health plans. But the bill does not give the patients enrolled in the various federal programs the supposed benefit of the bill.

The only apparent reason that the legislation does not include federal workers and federal beneficiaries, therefore, must be that Congress does not want to expose the federal government to litigation for non-economic damages. Since the government does not actually pay these damages, a further explanation must be that neither Congress nor the Administration wants to tell the person who does pay--the taxpayer--that taxes will be increased to pay for these lawsuits and awards for non-economic damages. Alternatively, neither Congress nor the Administration wants to ask federal workers and federal retirees or the beneficiaries of government health programs to accept lowered benefits to make up for the increased costs.

Congress and the Administration seemed to have calculated that it is politically easier to force private employers (and their employees, stockholders, and customers) to bear these increased costs, since they are not recouped through taxes. The politicians receive the political benefit of conferring more "rights" on people without having to pay the offsetting costs, financially or politically, for doing so.

CONCLUSION

The Patients' Bill of Rights is a bad solution to the real problem of patient frustration and the absence of patient choice. The Senate and House bills will expand federal regulation of the health care system (the Senate bill to a lesser degree at the outset). They would strengthen the notion that health care can be managed by government. And they would minimize the importance and value of individual choice. The House bill, in addition, would import the full panoply of tort litigation into coverage disputes and would subject employers who provide health benefits to new and major financial risks. It also would raise the cost of health insurance, cause employers to reduce their role in providing insurance, and increase the already high number of uninsured Americans.

Those who most need help in obtaining insurance are likely to be hurt first and hardest. Professor Alain Enthoven, a prominent health policy analyst at Stanford University, has exposed the core problem of the legislation:

I think the worst thing about much of the anti-managed care legislation now passed or in process is that, acceding to the demands of middle and upper income insured people who do not realize that they are in fact paying for their coverage, legislatures are outlawing the kind of truly cost effective health care coverage badly needed by people of modest means.53

The Patients' Bill of Rights legislation will result in a staggering amount of new red tape for American doctors, insurers, employers, and patients. The incentives, freedom, and flexibility that have produced the health care system that Americans have come to take for granted will be eroded and suppressed. Many Americans may be frustrated with their health care, but they do not need Members of Congress, yielding to the temptation to "do something," to make their situation worse.

John S. Hoff, Esq., is a prominent Washington, D.C., attorney specializing in health care law and health policy.


1. Title I of the Patients' Bill of Rights Plus Act (S. 1344).

2. The Bipartisan Consensus Managed Care Improvement Act (Division B of H.R. 2990), formerly H.R. 2723, known as the Norwood-Dingell bill.

4. John Shiels, the Lewin Group, letter to Rick Smith, American Association of Health Plans, November 17, 1997.

7. Survey by Harris Interactive Inc., in American Association of Health Plans, press release, "True Cost of Dingell-Norwood: 15 Million More Uninsured Americans," February 10, 2000, at http://www.aahp.org/services/communications/media/2000/cboscore.htm

8. The Senate bill contains regulatory provisions that are similar to those in the House version. However, the access provisions (and the prohibition against "gag clauses") apply only to self-insured group health plans--i.e., those that ERISA prevents state law from regulating. Other provisions, such as those delineating information that must be provided to members and the claims appeal procedures, would apply to all plans. There are other differences. For example, S. 1344 states that employer self-funded plans may not discourage members from paying on their own for behavioral health care services if, and after, the plan denies coverage. It is unclear why a private health plan would prohibit its members from self-paying for medical services (although the Health Care Financing Administration sought to do so in the Medicare program). But this provision implies that private health plans could somehow prevent members from self-paying for other non-covered services. S. 1344 grants the Agency for Healthcare Research and Quality wide-ranging authority, including the responsibility to coordinate all health care research and grant activities supported by the federal government. The main difference between the bills is that the Senate version does not contain the far-reaching provisions on litigation expansion that are in the House bill.

9. H.R. 2990, Section 1101. All references to the bills hereafter are to H.R. 2990, unless otherwise indicated.

10. Section 1102.

11. Section 1103. The bill is unclear as to whether a plan can appeal to the external body decisions by internal reviewers that a service is covered. Section 1103(a)(1) authorizes plans to appeal, but paragraph (a)(2) limits what can be appealed to an external review body to a denial of a claim for benefits.

12. Section 121 of the Senate bill reaches the same result in more oblique language. It requires the external reviewer to "make an independent determination based on...the evidence to determine the medical necessity...."

13. Section 1103(d).

14. Section 1103(f).

15. Section 1103(e).

16. It is unclear whether the phrase "such a plan or coverage" in Section 1103(e)(4) refers to the plan he worked for or any other plan as well.

17. Section 1104.

18. Section 1111.

19. Section 1112.

20. Section 1112(b)(1).

21. Section 1112(b)(2), (3).

22. Section 1114(a)(1)(B).

23. Section 1114(a)(2).

24. Section 1114(a)(4), (5).

25. Section 1114(b).

26. Sections 1115, 1116.

27. Section 1113.

28. Section 1117.

29. Section 1118.

30. Section 1119.

31. Section 1121.

32. Section 1131.

33. Section 1132. It uses the term "indemnification" rather than "payment."

34. Section 1135.

35. Section 1133.

36. Section 1153.

37. Sections 1111 through 1117.

38. Section 1152(a)(2).

39. Section 1152(a)(1).

40. Section 104(d).

41. Although the question of whether the federal statute creates state causes of action is unclear, the bill itself makes a negative implication that supports the idea that it does. Section 1302 would add to ERISA a new Section 514(f)(4), which provides that the repeal of the preemption of state law effected by Section 514(f) is not to 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." This implies that a denial of a right conferred by the bill could give rise to a state cause of action.

42. Section 1101(f)(2).

43. Section 1114(a)(1) and (2).

44. Section 1303 adds a new Section 502(o) to ERISA. Paragraph (1) provides that no action may be brought "under" ERISA for violations of a number of the bill's requirements, but paragraph (2) then provides that an action may be brought "under" ERISA for violations of many (but not all) of these--specifically, utilization review requirements, access to emergency, obstetrics/gynecology, pediatric, and continuing care, the ability to participate in clinical trials, and one part of the rules governing drug formularies. The section further states that such an action may not be a class action and that the relief may only provide for the provision or payment of the benefit denied (similar to the current ERISA limitation). On its face, this would appear to limit the damages that patients can recover for violations of the regulatory requirements--or even (although it is not clear) with respect to some of them prevent patients from bringing lawsuits. But it applies only to action brought "under" ERISA. If a tort suit is brought under state law, and the violation of the federal requirement is used as
evidence of a standard that the plan breached, the bar would not seem applicable.

45. See, generally, Karl Polzer, "ERISA Health Plan Liability: Issues and Options for Reform," National Health Policy Forum, 2000; U.S. General Accounting Office, Employer-Based Managed Care Plans, GAO/HEHS-98-154, 1998; and Patricia Butler, "ERISA Preemption Manual for State Health Policymakers," National Academy for State Health Policy, 2000.

46. Some states have already shown an inclination to do so, even though their laws may be preempted by current ERISA law. See William G. Schiffbauer and Dean A. Rosen, "Georgia's Application of Liability to Benefit Administration Ignores Legal Precedent," 8 Health L. Rpt. 1212 (BNA) July 22, 1999.

47. New ERISA Section 514(f)(1)(A), added by Section 1302.

48. New ERISA Section 514(f)(2).

49. New Section 514(f)(1)(B) of ERISA, added by Section 1302 of the bill.

50. New Section 514(f)(3) of ERISA, added by Section 1302, requires patients to exhaust the administrative remedies (the internal and external appeals) before "bringing an action under this subsection." However, a claim resulting from an adverse event will not be brought "under" Section 514, but under state law. In any event, Section 514(f)(3) explicitly states that the patient is not required to exhaust the administrative process if the injury has already occurred.

51. Before the October 1999 debate on the House version of the bill, Representative John Peterson (R-PA) submitted an amendment to the House Rules Committee that would have applied its provisions to all of the federal health programs, including the FEHBP and Medicare. The amendment (No. 29), along with many others, was rejected by the Rules Committee for floor consideration. See "Summary of Amendments Submitted to H.R. 2723, the Bipartisan Consensus Managed Care Improvement Act," Committee on Rules, U.S. House of Representatives, 106th Congress, 1st Sess., October 5, 1999.

52. See, e.g., Negron v. Patel, 6 F. Supp. 2d 366 (E.D. Pa. 1998). In the FEHBP, there is an internal and external review process for disputed claims and other disputes between federal workers and health plans. Only after an exhaustion of these administrative remedies may a federal employee have recourse to the federal courts. Action to recover claims must be brought directly against the Office of Personnel Management (OPM) and not against the health plan. According to federal regulations, "the recovery in such a suit shall be limited to a court order directing OPM to require the carrier to pay the amount of benefits in dispute." See 5 Code of Federal Regulations, Section 890.107(c).

53. Alain C. Enthoven, "Managed Care: What Went Wrong? Can It Be Fixed?" The Ozmun Lecture in Management, The Mayo Clinic, November 29, 1999.

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