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APRIL
22, 1999, THURSDAY
SECTION:
IN THE NEWS
LENGTH:
5783 words
HEADLINE:
PREPARED STATEMENT OF
ELEANOR D. KINNEY, J.D., M.P.H.
PROFESSOR OF LAW AND CO-DIRECTOR
THE CENTER FOR LAW AND HEALTH
INDIANA UNIVERSITY SCHOOL OF LAW
BEFORE THE
HOUSE
WAYS AND MEANS COMMITTEE
HEALTH SUBCOMMITTEE
SUBJECT - MEDICARE COVERAGE DECISIONS AND BENEFICIARY APPEALS
BODY:
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 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. 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 carder medical directors, a managed care medical director, and representatives of other federal health agencies. 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 following.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 for coverage.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
beneficiaries and
Medicare
providers. For
Medicare
beneficiaries, appeals procedures are different for beneficiaries who have enrolled in a
Medicare
+ Choice plan under Part C and 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 procedure 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 (AL J) 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 carder 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 heating proceeding before the carder.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 AL J.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 reconsideration/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 are 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 dental of Part B claims. There are two major types of issues in Part B appeals 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 proscribed 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. 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 the specter of being tied up in subsequent coverage disputes and payment denials.
The fourth stakeholder is the device medical 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 for 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 carder 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.
In sum, 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.
1 42 U.S.C. Section 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. Section 360c (1999).
4 (1987-1 Transfer Binder)
Medicare
& Medicaid Guide Paragraph 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 Fe.d 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., lst Sess. (1997) (Testimony Brace C. Viadeck, Administrator, Health Care Financing Administration).
9 See ACUS Recommendation 87-8,
National Coverage
Determinations under the
Medicare
Program, 1 C.F.R. Section 305.87-8); ACUS Recommendation 86-5,
Medicare
Appeals, I C.F.R. Section 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, I ADMIN. L. J. (Am. U.) I (1987).
10 American Bar Association, Section on Administrative Law and Regulatory Practice,
Medicare
Appeal Procedures (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. Section 1395w-21 (1999). 15 42 U.S.C. Section 139500 (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. Section 1395ff(1999).
20 Health Care Financing Administration,
Medicare
Carriers Manual Section 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., 101 st Cong., 1st Sess (1989)
23 U.S. GENERAL ACCOUNTING OFFICE, STATISTICS ON THE PART I 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's concerns).
25 American Bar Association, Section on Administrative Law and Regulatory Practice,
Medicare
Appeal Procedures (1988).
26 See, e..g, Warder v. Shalala, 149 F.3d 73 (5h Cir. 1998); Friedrich v. Secretary of Health and Human Services, 894 F.2d 829 (6th Cir. 1989); Mathews v. Shala(a, 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,
Medicare
& Medicaid Guide Paragraph 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. Section 1320c-4 (1999).
29 42 U.S.C. Section 1395ff(1999).
30 42 U.S.C. Section (1999).
31 42 U.S.C. Section 1395ff(b)(2) (1999).
32 42 U.S.C. Section 139ffcopyright (1999).
33 5 U.S.C. Sections 551-559 (1999).
34 42 U.S.C. Section 1395hh(b) (1999).
35 42 U.S.C. Section 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. Section 360c (1999).
38 467 U.S. 837 (1984)..
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