Statement of Eleanor D. Kinney, J.D., Professor of Law and Co-Director
Center for Law and Health, Indiana University School of Lawa

Testimony Before the Subcommittee on Health
of the House Committee on Ways and Means

Hearing on the Medicare Coverage Decisions and Beneficiary Appeals

April 22, 1999

It is an honor to appear before the Subcommittee on Health of the House Committee on Ways and Means to provide testimony on Medicare Coverage Policy Decisions and Beneficiary Appeals. In my testimony today, I would like to present some observations about the processes for making and implementing Medicare coverage policy and also the procedures available for beneficiaries and their assignees to appeal the adverse claim denials based on both national and local Medicare coverage policy.

BACKGROUND ON THE MEDICARE PROGRAM

Medicare is a federal program providing comprehensive health insurance for the elderly, severely disabled and people with End Stage Renal Disease. Medicare is the nation's largest health insurance program and covers 37 million Americans.

Traditional fee-for-service Medicare is comprised of two programs -- the Hospital Insurance program (Part A) and Supplementary Medical Insurance program (Part B). Part A covers hospital care and related home health and skilled nursing home care. Part B covers physician and other outpatient services. Under the fee-for-service program, Medicare beneficiaries obtain services directly from the providers they select. Medicare pays Part A providers directly under various payment methodologies. Assuming that the beneficiary assigns his or her claim for Part B benefits directly to the physician, supplier or other provider, Medicare pays the provider or supplier directly for the services.

In the Balanced Budget Act of 1997, Congress enacted a new "Part C" of the Medicare program -- the Medicare+Choice program. As of January 1, 1999, Medicare beneficiaries have the option of enrolling in Medicare+Choice plans. Medicare beneficiaries must select a Medicare+Choice plan or enroll in the traditional Medicare fee-for-service program under Parts A and B described above. Medicare+Choice plans must provide the array of benefits in Parts A and B but may offer additional benefits with savings achieved in efficient delivery of services to Medicare Beneficiaries.

BENEFITS AND COVERAGE UNDER THE MEDICARE PROGRAM

Benefits are the specific items and services included in the Medicare benefit package. Coverage defines the amount, duration and scope of the benefits for which the Medicare program will pay. The Medicare statute specifies the benefits to which beneficiaries are entitled in very general terms. Part A covers hospital care and related home health and skilled nursing home care. Part B covers physician and other outpatient services, including durable medical equipment. The Medicare statute lists excluded services, although now Medicare+Choice plans can provide some of these services from savings.

The Medicare statute contains a general coverage prescription that "items or services [which] are not reasonable and necessary for the diagnosis and treatment of an illness or injury, or to improve the function of a malformed body member" are not covered.(1) Decisions on whether Medicare covers an item or service are made by Medicare contractors that administer the Medicare program on behalf of the Health Care Financing Administration (HCFA) and initially adjudicate all claims for Medicare coverage and payment for beneficiaries enrolled in the fee-for-service program.(2)

Coverage policies and decisions fall into three categories depending on the type of item or service involved.

1. First is coverage policy pertaining to the amount and duration of a fairly conventional service, such as inpatient hospital care or home health services. This type of coverage policy is often implemented at the contractor level. The contractor may rely on the use of computerized screens to identify situations in which services exceed expected norms regarding amount and duration. Coverage policy for these services are contained in the applicable HCFA manual for the Medicare contractors or providers.

2. Second is coverage policy pertaining to items, namely medical devices used in the care of chronic illness or long term care. These items or devices are often sold as durable medical equipment and managed on the Part B side of the program. HCFA publishes coverage policy on these items chiefly in the list of durable medical equipment in the its Coverage Issues Manual.

3. Third are new medical technologies and procedures that are often experimental and come before the HCFA national office for a national coverage determination. HCFA publishes national coverage determinations in the Medicare Coverage Issues Manual. There is some overlap between the second and third categories of coverage policy.

In the early years of the Medicare program, coverage policy had been made chiefly by Medicare contractors at the local level. However, with the advances in expensive new medical technology, the Medicare program was faced with more issues on whether to cover new technologies which called for attention from the national office. In the early 1980s, HCFA began publishing national coverage determinations as coverage rulings in the Federal Register and contractor manuals.

In part, this pressure and concern came from medical device manufacturers that, as of 1976, had to get approval from the Food and Drug Administration (FDA) before marketing new medical devices to assure "the reasonable safety and effectiveness of medical devices intended for human use."(3) Medical device manufacturers were confounded when FDA approval did not necessarily result in Medicare coverage and that further review for Medicare coverage purposes was required. Beneficiaries and their physicians were concerned that their access to new technologies were limited by Medicare coverage determinations. Also many were concerned about the inconsistency of Medicare coverage policy nationwide as carriers had the authority to make coverage policy on a local basis. For example, in the early 1980s, heart transplants were covered in California but not in other parts of the country.

In 1987, as part of the settlement in Jameson v. Bowen,(4) which contested the application of a national coverage policy, HCFA promulgated a notice explaining its procedures for making coverage decisions.(5) In this notice, HCFA stated its intention to promulgate a rule for making national coverage determinations. In January 1989, HCFA promulgated a proposed rule establishing procedures and criteria but never published a complete final rule.(6) The rule was to establish criteria and procedures for HCFA decisions as to whether and under what circumstances specific health care technologies could be considered "reasonable" and "necessary" in more open and streamlined procedures with increased public participation and expedited procedures for "new breakthrough" technologies. In 1995, HCFA did publish a final rule with a comment period to specify conditions when Medicare would cover certain devices with an investigational device exemption through the FDA and certain services related to those devices.(7)

Previously, when making national coverage policy, HCFA conducted an internal review or consulted with its Technical Advisory Committee (TAC).(8) This committee was comprised of ten carrier medical directors, a managed care medical director, and representatives of other federal health agencies. The TAC could recommend that HCFA issue a national coverage policy, refer the issue for assessment by the Agency for Health Care Policy and Research or other qualified public or private assessment organization, postpone the decision pending more information, or make no decision. HCFA could accept or reject the TAC's recommendation. TAC proceedings were closed to the public and outside parties with an interest in the item or service under review had no opportunity to participate formally.

Many stakeholders, particularly the medical device industry, have been critical of the closed character of HCFA's coverage decision making process. In the 1980s, the Administrative Conference of the United States recommended that HCFA establish greater regularity and openness in its coverage decision making processes.(9) The American Bar Association also recommended similar reforms in Medicare coverage policy making.(10) Concerns about regularity and openness continue as troublesome issues today. GAO has been a persistent critic of HCFA's coverage decision making processes at both the national and local level.(11)

HCFA is currently redesigning its coverage decision making process. In September 1998, HCFA conducted a "town hall" on Medicare Coverage decision making and published a white paper.(12) HCFA has appointed a Medicare Coverage Advisory Committee comprised of outside experts that conducts meetings which are open to the public and at which requesters of coverage for a device or service can present their case.(13) HCFA plans to publish a notice shortly outlining the administrative process for making national coverage policy. HCFA also plans to develop general criteria that will guide in developing criteria for specific sectors of the health care industry.

BENEFICIARY APPEALS SYSTEMS UNDER THE MEDICARE PROGRAM

There are a multitude of appeals systems under the Medicare program depending on the type and status of the appellant and the subject matter of the dispute. In general, the two main types of appellants are Medicare those and Medicare providers. For Medicare beneficiaries, appeals procedures are different for beneficiaries who have enrolled in a Medicare+Choice plan under Part C and for those who have opted to remain in traditional fee-for-service Medicare under Parts A and B. For Medicare+Choice enrollees, there are grievance and appeal procedures within the managed care plan and then administrative and judicial review.(14)

Initially, the Medicare statute only permitted appeals on the part of beneficiaries with disputes over Part A services in the conventional administrative review structure of the Social Security Administration (SSA) of which the Medicare program was a part. Beneficiaries with concerns had a right to a fair hearing before the carrier. In 1972, responding to increased hospital and nursing home disputes over Medicare reimbursement, Congress established the Provider Reimbursement Review Board to adjudicate payment disputes of institutional providers.(15)

During the late 1970s and 1980s, there was increased pressure from beneficiaries and particularly providers for administrative and judicial review of Part B claims. In 1984, in Heckler v. Ringer,(16) the Supreme Court ruled that a beneficiary could not challenge a national coverage determination prohibiting coverage for bilateral carotid artery resections to relieve respiratory distress without exhausting administrative remedies and proceeding through the Social Security Act's appeals process. In part, beneficiaries, providers and particularly suppliers and manufacturers on their behalf wanted to challenge national coverage decisions and other Medicare coverage policy upon which claim denials were based.

Much concern was expressed about the fact that beneficiaries with Part B appeals did not have statutory administrative and judicial review but only fair hearings before carrier officials. The Supreme Court, in Schweiker v. McClure,(17) concluded that carrier Part B hearing procedures were sufficient and administrative review before an Administrative Law Judge (ALJ) and judicial review were not required under the procedural due process clause of the federal constitution. In 1985, the Subcommittee on Health of the Senate Finance Committee held hearings on Medicare appeals at which beneficiaries' complaints about the Part B appeals process was the central theme.(18) Nevertheless, in the Omnibus Budget Reconciliation Act of 1986, Congress established administrative review for part B claims, but also imposed significant limitations on administrative and judicial review of national coverage determinations.(19)

The Part B appeals process has been problematic since its inception. HCFA stirred up controversy in the late 1980s when it determined that it would retain carrier hearings for Part B claims.(20) This proposal was unsuccessfully challenged in Isaacs v. Bowen(21) which upheld HCFA's authority to retain this step. Then HCFA sought to create an administrative law judge corps within HCFA to adjudicate Part B disputes but backed away from the concept in the face of vigorous opposition on many fronts.(22) HCFA never implemented these plans. A GAO report found that the Part B administrative appeals process during these early years was quite lengthy.(23) Many are concerned about the Part B appeals process,(24) including the American Bar Association.(25) Problems have continued to surface in judicial decisions as well.(26) HCFA has acknowledged the need for reform.(27)

Medicare Fee-For-Service Appeal Procedures

Below are described the current appeal procedures for beneficiaries dissatisfied with determinations under Parts A and B of the Medicare program and who have elected the fee-for-service Medicare option.

Part A. Under Medicare Part A, which funds inpatient hospital and related post hospital services, beneficiaries may obtain administrative and judicial review of denied claims. For claims involving hospital services and utilization review determinations, beneficiaries must seek reconsideration before the Peer Review Organization (PRO). For claims over $200, beneficiaries may appeal adverse PRO determinations to an SSA ALJ and seek judicial review of adverse administrative decisions for claims of $2,000 or more.(28)

For all other beneficiary appeals under Part A, the beneficiary seeks reconsideration of the FI's determination. For claims involving $100 or above, they may appeal to an SSA ALJ with judicial review for claims of $1,000 or above.(29)

Part B. It should be emphasized that the right to appeal is for beneficiaries only and providers have rights to appeal only if they have accepted assignment of the beneficiaries claim and stand in the shoes of the beneficiary. The Part B appeals process retains the fair hearing proceeding before the carrier.(30) After the carrier's final disposition, a beneficiary may appeal an adverse determination if the amount in controversy is $500 or more to an SSA ALJ.(31) Judicial review is available for disputes of $1,000 or more.

Review of National Coverage Determinations. The Omnibus Budget Reconciliation Act of 1986 imposed significant limitations on the review of national coverage determinations.(32) Specifically, review of the coverage of any particular type or class of items or services is subject to the following limitations. Specifically, an ALJ may not review a national coverage determination. A court shall not set aside or invalidate a national coverage determination on grounds that requirements in the Administrative Procedure Act(33) relating to publication in the Federal Register or opportunity for public comment were not satisfied or that Medicare's rulemaking requirements(34) were not followed. Further, in any case in which a court determines that the record is incomplete or otherwise lacks adequate information to support the validity of a national coverage determination, it shall remand the matter to the Secretary for additional proceedings to supplement the record and the court may not determine that an item or service is covered except upon review of the supplemented record.

Medicare+Choice Appeal Procedures for Beneficiaries

Medicare+Choice plans must have "meaningful grievance procedures" with organizational determinations made by health plans and external review for reconsiderations.(35) The Secretary shall contract with an independent, outside entity to review and resolve in a timely manner reconsiderations that affirm denial of coverage. Following external review, there is administrative review before an SSA ALJ with subsequent judicial review.

THE CURRENT CONTROVERSY

The process for making Medicare coverage policy as well as adjudicating coverage in the cases of individual Medicare beneficiaries has been controversial. The historical development of the procedures for making Medicare policy and adjudicating appeals over its applications reflects this controversy. The reason for the controversy in the past and, especially for the future, is the collision of four forces:

• The increased provision of expensive care in outpatient settings and thus coming under the Part B side for claims administration and adjudication.

• The incredible advances in medical technology for the diagnosis and treatment of disease since the 1960s. However, this advance pales in terms of anticipated advances in medical technology in the future.

• The continuing inflation in Medicare program expenditures that threatens the solvency of the Medicare trust funds and puts great pressure on the federal budget of which Medicare constitutes a significant component.

• The increasing numbers of Medicare beneficiaries due to demographic changes in the elderly population as potential consumers of newly approved technologies.

It is worth looking at the interaction of these forces in some detail. The issue of technology is especially problematic for the Medicare program because it potentially translates into increased program expenditures with resulting pressures on Medicare trust funds and other sources of financing. The stewards of the Medicare program must be cognizant of these developments in formulating coverage policy for the Medicare program as expanded coverage for any item or service potentially contributes to increased program expenditures particularly if used in the care of many beneficiaries.

The battle over Medicare coverage policy is currently being fought out in the Part B appeals process. Beneficiary or, more likely, providers and suppliers who have accepted assignment from beneficiaries and are appealing on their behalf, are challenging the denial of Part B claims. There are two major types of issues in Part B appeals which need attention:

• Special situations in which the beneficiary could really benefit from a non-covered item or service in a cost effective treatment.

• Coverage policy applied to new technologies that inappropriately stifles development of medical innovation and hurts the legitimate business interests of device manufacturers.

The current Part B Appeals Process is not capable of adjudicating either type of issue. In neither case is the beneficiary or the manufacturer able to obtain the relief they desire. Regarding the application of coverage policy to beneficiaries in the first situation, at no point in the appeals process does a decision maker have any flexibility whatsoever to allow a prescribed item or service that might be of great benefit to a beneficiary and even save Medicare expenditures in the care of that beneficiary.

Regarding the impact on the manufacturers of new technologies, the appeal procedures do not provide a decision-maker at any level with authority to overturn a national coverage determination.

Even if an appeal comes before a federal court, the court must remand the policy back to HCFA for amplification and further development of the record.

Finally, for all Part B appeals, the appeals process is quite long with an internal appeal before the Medicare contractor and then administrative review and judicial review. It often takes many months -- well over a year -- to get through these layers of review.(36) A cumbersome process with no possibility of relief is frustrating and counter productive to all parties concerned.

IDEAS FOR REFORMS

In contemplating reforms, it is useful to identify the affected stakeholders and their legitimate interests in the Medicare coverage decision making process. The most important stakeholder is the Medicare beneficiary who has a legitimate interest in getting the best available treatment when in need.

The second stakeholder is HCFA, which stands in the shoes of Medicare beneficiaries who finance the Part B program with Part B premiums as well as current workers who finance Part B with their taxes. HCFA's interest is ensuring that it purchases health care services for beneficiaries in a cost effective manner. Such stewardship includes paying only for items or services that are proven to be effective in the treatment of illness and injury and not for items or services that are experimental or ineffective. HCFA has argued historically that the Medicare program should not finance the research and development of medical devices or procedures -- hence its strict adherence to the coverage exclusion of experimental items or services.

The third stakeholder is the provider community which has an interest in having the ability to use and prescribe the best treatment available for Medicare patients without the specter of administrative hassles in getting paid from the Medicare program. Institutional providers want to be able to purchase medical devices and other supplies without being tied up in subsequent coverage disputes and payment denials.

The fourth stakeholder is the medical device manufacturing industry which has an interest in bringing new products to market in an efficient and profitable manner. The device industry faces two regulatory barriers before getting a product to market: the device review process in the FDA(37) and the Medicare coverage decision making process. This latter process has a great impact on their ability to make a profit on their product and recoup their development costs. Understandably, device manufacturers want predictable, non-duplicative and efficient regulatory approval procedures to conserve expenses and get to market quickly.

Reform should proceed along the two major strategies: (1) reform of the Medicare coverage policy making process to make coverage policy in an open, accessible, expeditious and accurate manner, and (2) reform the appeals process to adjudicate cases in an expeditious manner. In my judgment, the two processes are joined at the hip. A well designed, open policy making process in which all interested parties can participate effectively and present their positions before responsible parties is the appropriate way to make coverage policy. Such a reformed process will alleviate the need for many to bring appeals. If the policy making process has sufficient credibility, disappointed requesters many not pursue some negative coverage decisions in the appeals process.

Reforms for the HCFA Coverage Decision Making Process

The HCFA coverage policy making process is the forum in which to determine whether a new medical procedure or device should be a covered Medicare benefit. The determination of this issue always involves the consideration of difficult "legislative" facts such as the cost implications of coverage and the medical benefit of new technology for beneficiaries. The HCFA coverage making process should be designed to marshal the best medical and scientific evidence available in the scientific literature and the results of relevant clinical trials. The process should obtain the scientific advice available both inside and outside of government. HCFA's establishment of the Medicare Coverage Advisory Committee is an excellent step in moving toward a sound policy making process.

Further, the HCFA coverage decision making process must allow for input from the individual or company promoting coverage of a medical device or procedure as well as other individuals or organization, such as medical specialty societies, other provider organizations and patient advocacy groups, with an interest in the coverage issue. These parties should have an opportunity to provide adequate written and possibly oral input in the coverage decision making process. This openness is critical to give the process credibility among affected parties, including the medical device industry, the provider community and beneficiaries.

HCFA might also consider making "probationary" coverage determinations that allow for a device or procedure to be tested and evaluated on a demonstration basis before a final coverage determination is made. Such a probationary procedure would have to be carefully designed to control Medicare expenditures for unproven medical technologies and would probably be used in only a few instances.

The following principles should guide the design of the coverage decision-making process from a procedural perspective:

• HCFA should provide adequate notice that its coverage decision making process is going to consider a national coverage determination or other coverage policy regarding a particular device or procedure. The notice should be provided in a manner likely to reach beneficiaries, providers, suppliers and device manufacturers.

• Requestors of Medicare coverage for a medical device or procedure, namely a medical device manufacturer, should have an adequate opportunity to present their case in oral and written form to the Medicare Coverage Advisory Committee and also to the officials in HCFA that will actually decide on the coverage policy.

• All other individuals or organizations, such as medical specialty societies, other provider organizations and patient advocacy groups, with an interest in the coverage issue should have an opportunity to provide adequate written and possibly oral input in the proceeding for making coverage policy.

• To the extent possible, the coverage decision making process should not impose requirements or otherwise duplicate the FDA device approval process.

Reforms of the Medicare Part B Appeals Process

Again, the current Part B appeals process is the battle ground on which the current disputes over the appropriateness of Medicare coverage policy regarding medical devices and procedures is being waged. The appeals process is not the proper forum for resolving issues of the validity or appropriateness of any given policy and, in particular, Medicare coverage policy. Neither ALJs nor federal judges have the technical expertise nor the broader perspective in the context of a single case to make decisions involving the correctness of a Medicare coverage policy.

Nor are current appeals systems adequate to address the claims of beneficiaries that have unique circumstances and could benefit from a particular non-covered item or service. For example, HCFA might specify that carriers could provide coverage for a specified non-covered item for beneficiaries with particular needs and where other covered treatments have failed. Many insurance companies and managed care organizations provide non-covered services on this basis. Ideally, the carrier could be accorded the discretion to decide such cases and also to establish the requisite case management oversight to ensure the safety of the beneficiary and conserve Medicare dollars. The carrier fair hearings might appropriately be used to appeal such special situations when the carrier has already denied coverage.

The following principles should guide reform of the Part B appeals process:

• The interests of beneficiaries should be paramount and appeals procedures should be designed to adjudicate their concerns effectively.

• Appeal procedures should be as streamlined as possible and extra layers of review should be implemented only if they serve a particular purpose required to facilitate the expeditious and fair resolution of the disputes.

• ALJs and other adjudicators should not have authority to consider the validity of Medicare coverage policy and, in particular, national coverage determinations.

The Part B appeals process is not the forum to adjudicate the validity or appropriateness of HCFA coverage policy. It has been called to do so because the national coverage policy process to date has been inadequate to provide a forum for interested parties, including beneficiaries, providers and device manufacturers to raise their concerns and arguments regarding the coverage of a new medical device or procedure in the first instance.

However, the question remains as to what appeal procedures and forums should be available to enable providers, device manufacturers and other interested parties to challenge HCFA's decision on the coverage of a particular medical device or procedure. In Chevron, U.S.A., Inc. v. National Resources Defense Council,(38) the Supreme Court established the principle that reviewing federal courts have limited authority to overturn agency policies and interpretations of their enabling legislation. The Court's rationale for its clear preference for limited judicial review of agency policy is that the agency has ultimate responsibility to manage the statutorily mandated program and needs to have the authority to make the requisite policies and decisions to carry out their statutory assignments.

In sum, Congress should think carefully about the implications of giving final authority over Medicare coverage policy to a court or other decision maker that is not accountable for the fiscal performance of the Medicare program or the safety and welfare of its beneficiaries. The better approach, in my judgment, is to focus on improving HCFA's Medicare coverage decision making process in the first instance to make it truly open to beneficiaries and their providers and the developer of new medical technologies that are so important in the advance of medical care.

CHRONOLOGY

Key Legislative Developments

Social Security Amendments of 1965, Pub. L. No. 89-97 (1965).

• Establishing the Medicare program is established with appeal rights only for beneficiary concerns over hospital services.

Social Security Amendments of 1972, Pub. L. No. 93-603 (1972).

• Expanding Medicare eligibility to include the disabled on the Social Security Disability Insurance Program.

Medical Device Amendments of 1976, Pub. L. No. 94-295 (1976).

• Establishing FDA approval of medical devices.

Tax Equity and Fiscal Responsibility Act of 1982, Pub. L. 97-248(1982).

• Establishing the Peer Review Organization Program with Peer Review Organizations to review hospital expenditures.

Social Security Amendments of 1983, Pub. L. No. 98-21 (1983).

• Establishing the DRG Prospective Payment System for Hospitals.

Omnibus Budget Reconciliation Act of 1986, Pub. L. No. 99-509 (1986).

• Authorizing Administrative and Judicial Review for Part B Claims.

• Establishing Special Rules for Appeals of National Coverage Determinations.

Omnibus Budget Reconciliation Act of 1989, Pub. L. No. 101-239 (1989).

• Establishing Resource-Based, Relative Value Scale for determining Medicare payment to Physicians.

• Establishing the Agency for Health Care Policy and Research with the authority to conduct technology assessments.

Omnibus Budget Reconciliation Act of 1993, Pub. L. No. 103-66 (1993)

• Reforming Payment Methods for Durable Medical Equipment.

Budget Balanced Budget Act of 1997, Pub. L. No. 105-33, 111 Stat. 251 (1997).

• Establishing the Medicare+Choice Program (Part C) to replace the Medicare HMO program.

Key Rules and Notices on Medicare Coverage Policy Making Procedures

Health Care Financing Administration, Medicare Program, Procedures for Medical Services Coverage Decisions; Request for Comments, 52 Fed. Reg. 15,560 (Apr. 29, 1987).

Health Care Financing Administration, Medicare Program; Criteria and Procedures for Making Medical Service Coverage Decisions That Relate to Health Care Technology, 54 Fed. Reg. 4302 (Jan. 30, 1989).

Health Care Financing Administration, Medicare Program; Criteria and Procedures for Extending Coverage to Certain Devices and Related Services, 60 Fed. Reg. 48,417 (Sept. 19, 1995).

Health Care Financing Administration, Medicare Program; Establishment of the Medicare Coverage Advisory Committee and Request for Nominations for Members, 63 Fed. Reg. 68,780 (Dec. 14, 1998).

Major Congressional Hearings on Appeals

Medicare Appeals Provisions: Hearings Before the Subcomm. On Health of the Senate Comm. On Finance, 99th Cong., 1st Sess. (1985).

Oversight Hearing on Adjudicatory Procedures of the Dep't of Health & Human Services Before the Subcomm. on Administrative Law and Government Relations of the House Judiciary Comm., 101st Cong., 1st Sess (1989).

Issues Relating to Medicare's Coverage Policy, Hearing before Subcommittee on Health of the House Comm. On Ways and Means, 105th Cong., 1st Sess. (April 17, 1997).

Medicare Appeals Processes: Hearings Before the Subcommittee on Health House Committee on Ways and Means, 105th Cong., 2nd Sess. (Apr. 23, 1998).

The Medicare Coverage Process and Beneficiary Processes: Hearings Before the Subcommittee on Health House Committee on Ways and Means, 106th Cong., 1nd Sess. (Apr. 22, 1999).

1. 42 U.S.C. § 1395y(a)(1) (1999).

2. The Medicare contractors for Part A are insurance companies called fiscal intermediaries (FIs). For hospitals, Professional Review Organizations (PROs) conduct utilization and quality review of hospital inpatient services. The Medicare contractors for Part B are health insurance companies called carriers. In the Medicare+Choice program, the prepaid health plans contract directly with HCFA and implement coverage policy.

3. 42 U.S.C. § 360c (1999).

4. [1987-1 Transfer Binder] Medicare & Medicaid Guide ¶ 36,033 (E.D. Cal. Feb. 20, 1987) (Settlement Agreement and Release of Claims).

5. Health Care Financing Administration, Medicare Program, Procedures for Medical Services Coverage Decisions; Request for Comments, 52 Fed. Reg. 15,560 (Apr. 29, 1987).

6. Health Care Financing Administration, Medicare Program; Criteria and Procedures for Making Medical Service Coverage Decisions That Relate to Health Care Technology, 54 Fed. Reg. 4302 (Jan. 30, 1989).

7. Health Care Financing Administration, Medicare Program; Criteria and Procedures for Extending Coverage to Certain Devices and Related Services, 60 Fed. Reg. 48,417 (Sept. 19, 1995).

8. Issues Relating to Medicare's Coverage Policy, Hearing before Subcommittee on Health, 105th Cong., 1st Sess. (1997) (Testimony Bruce C. Vladeck, Administrator, Health Care Financing Administration).

9. See ACUS Recommendation 87-8, National Coverage Determinations under the Medicare Program, 1 C.F.R. § 305.87-8; ACUS Recommendation 86-5, Medicare Appeals, 1 C.F.R. §305.86-5. See also Eleanor D. Kinney, National Coverage Policy Under the Medicare Program: Problems and Proposals for Change, 32 St. Louis U.L.J. 869 (1988); Eleanor D. Kinney, The Medicare Appeals System for Coverage and Payment Disputes: Achieving Fairness in a Time of Constraint, 1 Admin. L. J. (Am. U.) 1 (1987).

10. American Bar Association, Recommendations on Medicare Procedures by the ABA House of Delegates (August 1988).

11. See, e.g., U.S. Gen. Accounting Off., Medicare Part B: Regional Variation in Denial Rates for Medical Necessity (1994); U.S. Gen. Accounting Off., Medicare-Technology Assessment and Medical Coverage Decisions (1994).

12. Health Care Financing Administration, How Coverage Review is Conducted: White Paper for Town Hall Meeting Held on September 25, 1998 (1999).

13. Health Care Financing Administration, Medicare Program; Establishment of the Medicare Coverage Advisory Committee and Request for Nominations for Members, 63 Fed. Reg. 68,780 (Dec. 14, 1998).

14. 42 U.S.C. §1395w-21(1999).

15. 42 U.S.C. §1395oo (1999).

16. 466 U.S. 602 (1984).

17. 456 U.S. 188 (1982).

18. Medicare Appeals Provisions: Hearings Before the Subcomm. On Health of the Senate Comm. On Finance, 99th Cong., 1st Sess. (1985).

19. 42 U.S.C. §1395ff (1999).

20. Health Care Financing Administration, Medicare Carriers Manual § 12195B (1986).

21. 865 F.2d 468 (2d Cir. 1989).

22. See Oversight Hearing on Adjudicatory Procedures of the Dep't of Health & Human Services Before the Subcomm. on Administrative Law and Government Relations of the House Judiciary Comm., 101st Cong., 1st Sess (1989).

23. U.S. General Accounting Office, Statistics on the Part B Administrative Law Judge Hearings Process (1989).

24. See, e.g., Judith G. Waxman & Alfred J. Chiplin, Jr., Medicare Part B Appeals -- and You Thought the System was Fixed, Clearinghouse Rev. 384 (Special Issue, Summer 1989); Bess M. Brewer, Risky Business: Five Years of Navigating the Medicare Part B Appeals Process, Clearinghouse Rev. 537 (Sept. 1992) (raising beneficiary concerns); Timothy P. Blanchard, Medical Necessity Denials as a Medicare Part B Cost-Containment Strategy: Two Wrongs Don't Make it Right or Rational, 34 St. Louis. U.L.J. 939 (1990) (raising provider concerns).

25. American Bar Association, Recommendations on Medicare Procedures by the ABA House of Delegates (August 1988).

26. See, e..g, Warder v. Shalala, 149 F.3d 73 (5th Cir. 1998); Friedrich v. Secretary of Health and Human Services, 894 F.2d 829 (6th Cir. 1989); Mathews v. Shalala, 1997 WL 124106 (S.D.N.Y., Mar. 18, 1997); Cedars -Sinai Medical Center v. Shalala, 939 F.Supp. 1459 (C.D. Cal. 1996); Bosko v. Shalala, [Transfer Binder 1997-1] Medicare & Medicaid Guide ¶ 45, 139 (W.D. Pa. Aug. 28, 1996).

27. Medicare Appeals Process: Hearings before the Subcomm. On Health of the House Comm. On Ways and Means, 105th Cong., 2d Sess. (Apr. 23, 1998) (Testimony of Michael M. Hash, Deputy Director, Health Care Financing Administration).

28. 42 U.S.C. §1320c-4 (1999).

29. 42 U.S.C. § 1395ff (1999).

30. 42 U.S.C. §1395u (1999).

31. 42 U.S.C. § 1395ff(b)(2) (1999).

32. 42 U.S.C. § 139ff(c) (1999).

33. 5 U.S.C. §§ 551-559 (1999).

34. 42 U.S.C. § 1395hh(b) (1999).

35. 42 U.S.C. §1395w-21 (1999). See Jennifer E. Gladieux, Medicare+Choice Appeal Procedures: Reconciling Due Process Rights and Cost Containment, 25 Am. J. L. & Med. 61 (1999).

36. Medicare Appeals Processes: Hearings Before the Subcommittee on Health House Committee on Ways and Means, 105th Cong., 2d Sess. (Apr. 23, 1998) (Testimony of Michael M. Hash, Deputy Director, Health Care Financing Administration).

37. 42 U.S.C. § 360c (1999).

38. 467 U.S. 837 (1984).