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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Western Area Power Administration

CFR Citation: 42 CFR Parts 400, 405, and 426

RIN ID: RIN 0938-AK60

CMS ID: [CMS-3063-F]

NOTICE: Part IV

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: Medicare Program: Review of National Coverage Determinations and Local Coverage Determinations

EFFECTIVE DATES: The provisions set forth in this final rule are effective December 8, 2003.

DOCUMENT SUMMARY: This final rule will create a new process to allow certain Medicare beneficiaries to challenge national coverage determinations (NCDs) and local coverage determinations (LCDs). It will implement portions of section 522 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000. The right to challenge NCDs and LCDs will be distinct from the existing appeal rights that Medicare beneficiaries have for the adjudication of Medicare claims.

SUMMARY: Health and Human Services Department, Centers for Medicare & Medicaid Services,

SUPPLEMENTAL INFORMATION

To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 152507954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 5121800 (or tollfree at 18882936498) or by faxing to (202) 5122250. The cost for each copy is $10. As an alternative, you can view and photocopy the Federal Register document at most libraries designated as Federal Depository Libraries and at many other public and academic libraries throughout the country that receive the Federal Register.

This Federal Register document is also available from the Federal Register online database through GPO Access, a service of the U.S. Government Printing Office. The Web site address is http://www.access.gpo.gov/nara/index.html .

Note: The former name of the Centers for Medicare & Medicaid Services (CMS) was the Health Care Financing Administration (HCFA). The terms CMS and HCFA can be used interchangeably.

In addition, because of the many terms to which we refer by acronym in this final rule, we are listing these acronyms and their corresponding terms in alphabetical order below.
ALJAdministrative Law Judge
CACCarrier Advisory Committee
CMPComprehensive Medical Plan
DMERCDurable Medical Equipment Regional Carrier
FIFiscal Intermediary
HCPPHealth Care Prepayment Plan
HMOHealth Maintenance Organization
LCDLocal Coverage Determination
LMRPLocal Medical Review Policy
M+CMedicare+Choice
MCACMedical Coverage Advisory Committee
NCDNational Coverage Determination
QIOQuality Improvement Organization
RHHIRegional Home Health Intermediary
I. Background

A. Background of Rulemaking

On August 22, 2002, we issued a proposed rule (67 FR 54534) implementing certain provisions of section 522 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), proposing a process for the review of local coverage determinations (LCDs) and national coverage determinations (NCDs). The notice and comment period closed on October 21, 2002. We received 31 timely comments, which were quite useful in identifying issues and concerns. We have made significant changes to this final rule to address the public comments. We believe that these changes will contribute to a fairer and more efficient process. Significant changes to the proposed rule based on public comments, which are discussed in section III, below, include:
[sbull] More broadly defining beneficiaries ``in need.'' [sbull] Reducing the burden for physician certification requirements.
[sbull] Allowing for participation in the BIPA section 522 adjudicatory process as an amicus curiae (friend of the court) for NCD appeals.
[sbull] Creating a mechanism to allow new evidence to be received subject to timelimited remands.
[sbull] Expanding the effect of a final decision by the Administrative law judge (ALJ) or the HHS Departmental Appeals Board (Board).
B. Overview of Existing Statutes, Regulations, and Policies

Medicare is the nation's largest health insurance program covering approximately 41 million Americans. Beneficiaries consist primarily of individuals 65 years of age or older, some disabled people under 65 years of age, and people with endstage renal disease (permanent kidney failure treated with dialysis or a transplant).

The original Medicare program consists of two parts. Part A, known as the hospital insurance program, covers certain care provided to inpatients in hospitals, critical access hospitals, skilled nursing facilities, as well as hospice care and some home health care. Part B, the supplementary medical insurance program, covers certain physicians' services, outpatient hospital care, and other medical services that are not covered under Part A. While the original Medicare program covers many health care items and services, it does not cover all health care expenses. The Medicare statute specifically excludes from coverage certain items and services under section 1862(a) of the Social Security Act (the Act).

In addition to the original Medicare program, beneficiaries may elect to receive health care coverage under the Medicare+Choice (M+C) program under Part C of the Medicare program. This program provides beneficiaries with various options, including the right to choose a Medicare managed care plan or a Medicare private feeforservice plan. Under the M+C program, an individual is entitled to those items and services (other than hospice care) for which benefits are available under Part A and Part B. An M+C plan may provide additional health care items and services that are not covered under the original Medicare program.

The Act gives beneficiaries specific rights to challenge particular types of decisions. We are committed to providing beneficiaries an opportunity to fully exercise these statutory rights. Moreover, we are committed to resolution of these disputes in a fair and efficient manner.

C. Claims Appeal Process

Under the original Medicare program, a beneficiary may generally obtain health services from any institution, agency, or person qualified to participate in the Medicare program that undertakes to provide the service to the individual. Assuming that a qualified provider or supplier has furnished medical care, the health care provider or supplier, or, in some cases, a beneficiary would submit a claim for benefits under
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the Medicare program. If the claim is for an item or service that falls within a Medicare benefit category, is reasonable and necessary for the individual, and is not otherwise statutorily excluded, a government contractor (either a fiscal intermediary for claims under Part A or Part B, or a carrier for claims under Part B) would pay the claim. However, if the Medicare contractor determines that the medical care is not covered under the Medicare program, the Medicare contractor would deny the claim.

This final rule does not seek to significantly alter the existing claims appeal process. Nor does this rule significantly alter our existing regulations for M+C beneficiaries as established at Sec. 422.560 through Sec. 422.622. However, it does create an expanded definition of aggrieved party to include a beneficiary who received a service, but whose claim for the service was denied, extending an opportunity to that beneficiary to file a complaint under Sec. 426.400 or Sec. 426.500. For further discussion of the claims appeal process please consult the proposed rule.

D. National Coverage Determinations (NCDs)

Section 1869(f)(1) of the Act defines national coverage determination as ``a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII, but does not include a determination of what code, if any, is assigned to a particular item or service covered under this title or a determination with respect to the amount of payment made for a particular item or service so covered.'' For the full discussion of NCDs please consult our proposed rule at 67 FR 54535 published on August 22, 2002.

E. Local Medical Review Policy (LMRP)

As explained in the preamble to the proposed rule, Local Medical Review Policies are contractorspecific policies that identify the circumstances under which particular items or services will be (or will not be) considered covered and correctly coded. An LMRP is not controlling authority for ALJs or the Board in the claims appeals process. These guidelines simply help to ensure that similar claims are processed in a consistent manner within those jurisdictions. LMRPs may not conflict with an NCD, but may be written in the absence of, or as an adjunct to, an NCD.

An LMRP may contain any or all of the following: [sbull] Coding provisions.
[sbull] Benefit category provisions.
[sbull] Statutory exclusion provisions.
[sbull] Provisions related to the authority under section 1862(a)(1)(A) of the Act, which prohibits payment for any expenses incurred for services that are not reasonable and necessary for the diagnosis or treatment of illness or injury, or to improve the functioning of a malformed body member.

Some LMRPs contain only a single type of provision, while other LMRPs contain all four types. The provisions described in bullets two through four above constitute coverage provisions.

For further information on LMRPs please consult our proposed rule at 67 FR 54535.

F. Local Coverage Determinations

Section 522 of BIPA does not use the term ``LMRP,'' but uses the term ``Local Coverage Determination'' (LCD). Section 522 of BIPA amends section 1869(f)(2)(B) of the Act, to define LCD as ``a determination by a fiscal intermediary or a carrier under part A or part B, as applicable, respecting whether or not a particular item or service is covered on an intermediaryor carrierwide basis under such parts, in accordance with section 1862(a)(1)(A).''

An LMRP may contain four different types of provisions (coding, benefit category, statutory exclusion, and reasonable and necessary). Section 1869(f)(2)(B) of the Act limits an LCD as a determination only under section 1862(a)(1)(A) of the Act's ``reasonable and necessary provision.'' For the purposes of this regulation, we will use the term ``reasonable and necessary provision'' to describe section 1862(a)(1)(A) of the Act. We intend to work with contractors to divide LMRPs into separate LCD and nonLCD documents; however, it is likely that LMRPs will continue to exist for the next several years. During this time, the term LCD will refer to both of the following: [sbull] Separate, standalone documents entitled ``LCDs'' that contain only reasonable and necessary language; and
[sbull] The reasonable and necessary provisions of an LMRP. G. Differences Between NCDs and LMRPs/LCDs

Under our claims appeals process, ALJs may consider, but are not bound by, LMRPs or LCDs. Thus, an ALJ may rule that Medicare payment is due on a particular item or service received by a beneficiary, based on the particular circumstances represented by the case, even if the contractor's LMRP or LCD clearly prohibits payment for the particular service. (We note that a regulation which may impact ALJ consideration of LCDs in claims appeal cases has been proposed. See 67 FR 69328, 69351.) On the other hand, contractors and ALJs are bound by NCDs. ALJs may not review an NCD.

H. Individual Claim Determinations

In addition to policy determinations, contractors may make individual claim determinations, even in the absence of an NCD, LMRP, or LCD. In circumstances when there is no published policy on a particular topic, decisions are made based on the individual's particular factual situation. See Heckler v. Ringer, 466 U.S. 602, 617 (1984) (recognizing that the Secretary has discretion to either establish a generally applicable rule or to allow individual adjudication).
I. Impact of Section 522 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA)

1. Overview of the Legislation

Section 522 of the BIPA created a new review process that enables certain beneficiaries to challenge LCDs and NCDs. These appeal rights are distinct from the existing appeal rights for the adjudication of Medicare claims. This section also creates additional avenues for beneficiaries to seek judicial review. Before BIPA, the statute did not provide an administrative avenue to challenge the facial validity of LCDs or NCDs.
2. Differences Between the Claims Appeal Process and the LCD/NCD Review Processes

The existing claims appeal rights were not significantly changed by section 522 of the BIPA. Our claims appeal regulations will continue to provide detailed administrative appeal rights for beneficiaries whose claims are denied. These claims appeal procedures permit beneficiaries to challenge the initial claims denial and include de novo review by an independent ALJ. If still dissatisfied after exhausting all administrative remedies, a beneficiary has a right to seek judicial review in a Federal district court. This claim appeal system enables beneficiaries to submit any relevant information pertaining to an individual claim. Moreover, because LCDs are not controlling authorities for ALJs, when an ALJ does not find an LCD persuasive, an individual claim appeal could result in the claim being paid without the need to challenge the underlying LCD. We have proposed rules that would modify the claims appeals process at 67 FR 69312 (November 15, 2002).

Section 522 of the BIPA created a review process that is separate and
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independent from the claims appeal process. This process will be different, because the nature of the challenge and the relevant evidence is different. The procedures used in this process will be different from the claims appeals process. Review of an LCD or NCD requires examination of an entire policy, or specific provisions contained therein, and not just one claim denial. Therefore, such reviews may lead to changes that impact other beneficiaries if the policies are found to be unreasonable. A beneficiary, thus, may elect to pursue a claims denial through the claims appeal process, seek review of an LCD or NCD using the process in this final rule, or both. In no way does filing a 522 challenge, or a decision on a 522 challenge, affect beneficiary appeal rights or other issues that may arise in the claims appeal process.

Complaints under section 522 of the BIPA are subject to standing rules. Namely, under section 1869(f)(5) of the Act ``[a]n action under this subsection seeking review of a national coverage determination or local coverage determination may be initiated only by individuals entitled to benefits under part A, or enrolled under part B, or both, who are in need of the items or services that are the subject of the coverage determination.'' In this final rule, we are interpreting the standing provision to include individuals who have received the item or service and whose initial claim was denied based on an LCD or NCD and, thus, are in need of Medicare coverage. We will also permit the estates of certain individuals to have standing. Only individuals who have standing may bring a challenge under section 522 of the BIPA, and in this final rule, we refer to these individuals as ``aggrieved parties.''

As discussed in the proposed rule, the aggrieved party may not assign the right to bring a challenge under section 522 of the BIPA to anyone else. However, the aggrieved party is permitted to obtain assistance from any individual in pursuing the challenge. (We discuss the difference between assigning rights and receiving assistance in section IV of this final rule.)

The definition of an ``aggrieved party'' will permit an individual to bring a challenge to an LCD or NCD in advance of receiving an item or service, or after the LCD or NCD is applied to a claim causing the claim to be denied. As we discuss in greater detail in section IV.E of this preamble, a successful challenge would permit the individual to have his or her specific claim reviewed without reference to the challenged policy. Claims that are otherwise payable can be paid. In addition, a successful challenge to an LCD or NCD may result in the following:
[sbull] The policy being retired/withdrawn in its entirety, or [sbull] The policy being revised to effectuate the Board decision, or the ALJ decision if it is not appealed to the Board.

3. The Reconsideration Process

We previously established a procedure by which individuals could seek reconsideration of policies established in an LCD or NCD. The procedures for NCDs were set forth in the September 26, 2003 notice (68 FR 55634, 55641). The procedures for LCDs were set forth in the Program Integrity Manual, Chapter 13, Section 11.

4. The Role of Other Interested Individuals or Entities

The section 522 review process is intended to be initiated only by aggrieved parties. However, consistent with several public comments, we are expanding Sec. 426.510(f) to allow for limited participation in an NCD challenge by other individuals as amicus curiae when the individuals or entities meet the standards set forth in these regulations. Please note that the reconsideration process described in section I.I.3 of this preamble remains the appropriate process by which all other interested entities may submit new evidence pertaining to the review of current LCDs and NCDs.
5. Differences Between an LCD/NCD Review and an LCD/NCD Reconsideration

The main difference between an LCD/NCD review under section 522 of the BIPA and an LCD/NCD reconsideration is the avenue an individual chooses to take to initiate a change to a coverage policy and who may initiate the review. All interested parties, including an aggrieved party, may request a reconsideration of an LCD or NCD, rather than filing a complaint to initiate the review of an LCD or NCD. Conversely, only an aggrieved party may file a complaint to initiate the review of an LCD or NCD. If the aggrieved party believes that we, or the contractor, misinterpreted evidence or excluded available evidence in making the coverage determination or has new evidence to submit, then the aggrieved party has the option to file a request for a reconsideration by the contractor or us, respectively, or to file a complaint to seek review by an adjudicator.

In the reconsideration process, all interested parties, not just aggrieved parties, have the opportunity to submit new scientific and medical evidence for review by individuals with medical and scientific expertise. The reconsideration process permits experts to make judgments about those policies, rather than using an adjudicatory proceeding.

II. Provisions of the Proposed Rule

For a discussion of the specific provisions of the proposed rule, please see 67 FR 5453454563. The significant changes to the final rule, based on public comments, are reflected in section III, below. III. Analysis of and Response to Public Comments

We received 31 comments from the public on the proposed rule. Summaries of the major comments received and our responses to those comments are set forth below.

Definition of an NCD

Comment: We received several comments on our interpretation of what qualifies as an NCD, and which policies are subject to review. Some public comments stated that we interpreted the statute too narrowly, and that additional policies should be subject to review; other public comments suggested that we interpreted the statute too broadly, and that benefit category determinations should not be defined as NCDs, and should not be subject to review before the Board.

Response: Our definition of an NCD is consistent with the statutory language, and we are not accepting the public comments that suggest the definition is either too broad or too narrow. We continue to believe that the statute is clear, and that the Congress has created a new definition of NCD to include benefit category determinations. The Congress's definition of an NCD is now broader than the prior statute at section 1869(b)(3) of the Act. Moreover, it is broader than the definition of LCD that is specifically limited to determinations made in accordance with section 1862(a)(1)(A) of the Act. We presume that the Congress acted intentionally and precisely in defining an NCD, and we are following that definition in this final rule.

Definition of LCD

Comment: One commenter suggested that an LCD should be synonymous with LMRP.

Response: Because the statutory definition of an LCD is limited to the reasonable and necessary provisions in section 1862(a)(1)(A) of the Act, we could not make the definition of an LCD synonymous with the definition of an LMRP. As discussed earlier in this preamble, an LMRP may contain coding,
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benefit category, and statutory exclusion provisions that are not based on section 1862(a)(1)(A) of the Act.

Comment: Several commenters suggested that both procedure codes and diagnosis codes be included within the definition of LCD. These commenters stated that the final regulation should not preclude an aggrieved party from challenging the reasonable and necessary provisions of an LCD that contain diagnosis codes.

Response: An LCD or LMRP provision stating that a service is not reasonable and necessary for specified diagnoses (whether listed in text or listed by ICD9 diagnosis code) is considered part of the LCD. Definition of an Aggrieved Party

Comments: We received two comments in support of our proposed definition of an aggrieved party as a beneficiary in need of a service and who has not yet received the service that is the subject of the coverage determination. While these commenters felt that it is correct to allow aggrieved parties to initiate the review of an LCD or NCD, they wrote that opening up the LCD/NCD review process to beneficiaries who have already received the service would result in unnecessarily complicated adjudications. However, over half of all commenters on the rule suggested that the definition was too narrow and should be expanded. Some commenters stated that the proposed definition was far too restrictive and suggested that we remove the requirement that the service not be received at the time the complaint is filed. One commenter pointed out that the proposed definition would insulate certain LCDs and NCDs from ever being challenged because some LCDs/NCDs address services that are only used in emergency or urgent situations where the beneficiary would be incapable of filing a challenge prior to receiving the service. Some commenters suggested that beneficiaries would lose their section 522 rights if they chose not to forego urgent treatment. One commenter suggested that we revise the definition to require that the beneficiary be in need of coverage for a service. One commenter specifically requested the establishment of an emergency appeals process.

Response: In response to these comments, we have interpreted the statutory requirements more broadly and have expanded the definition of aggrieved party to require that the beneficiary be in need of coverage of a service. Therefore, the definition includes beneficiaries who have already received the service. We believe this change obviates the need for an emergency appeals process because a beneficiary can obtain an emergency service and then seek review without forgoing his or her rights. In order to define which beneficiaries have standing as aggrieved parties, we have added a requirement in Sec. 426.400(b)(2) and Sec. 426.500(b)(2) that aggrieved parties, who have received a service and have filed a claim, must file their section 522 challenge within 120 days of the date of the initial denial notice from the contractor.

Comment: One commenter stated that beneficiaries should be allowed to challenge coverage NCDs as well as noncoverage NCDs.

Response: We conclude in this final rule that a beneficiary is aggrieved by an NCD only if it denies coverage for a service which that beneficiary needs. Therefore, the ALJ/Board may accept a complaint regarding an NCD that limits coverage. Since the Congress provided for review upon the filing of a complaint by an aggrieved party, we believe that the Congress intended the process to be available only when the beneficiary is in need of coverage for an item or service that would be denied or has been denied, under an LCD or NCD.

Allowing a Beneficiary To Assign Appeal Rights

Comment: We received a number of public comments suggesting that the aggrieved party should be able to assign LCD or NCD review rights under section 522 of the BIPA to another person or entity. Several of the comments suggested that the procedures were complex and that, by enabling a beneficiary to assign the rights to another person, it would relieve the beneficiary of the burden of participating in the process and would be more equitable, or, perhaps, more efficient. One commenter suggested that permitting providers to be aggrieved parties would have been consistent with an earlier proposal in a Senate bill. Some commenters suggested that allowing physicians or other interested parties to assist the beneficiary in requesting review would be useful to beneficiaries. Other commenters recognized that the Medicare program permitted the assignment of rights in other contexts.

On the other hand, one commenter noted that the statute requires a beneficiary in need to initiate a review. Another commenter agreed with our proposal, and believed it would be inappropriate under the statute to permit the assignment of rights to request a review of an LCD or NCD to other interested parties. That commenter noted that the ``Medicare program is fundamentally a beneficiary, or patient, program designed to assure access to clinically sound services.''

Response: We are retaining our position that an aggrieved party may not assign legal rights to request a review of an LCD or NCD to a third party, but are clarifying our rules to ensure that a challenger is not precluded from obtaining assistance or representation from individuals or entities who may assist the beneficiary in pursuing the individual's appeal.

We agree with the commenter who suggested that the statute was clear in this regard. The standing provision in section 1869(f)(5) of the Act is precise. Moreover, as one commenter correctly observed, a broader standing provision, that would have enabled other interested parties to file complaints about LCDs and NCDs, existed in earlier drafts of the legislation. It appears that the Congress's narrowing of the language in the final bill was intentional and deliberate. We do not believe it would be consistent with this history to expand the scope of individuals who have a legal right to initiate and pursue a challenge to an LCD or NCD.

We do, however, agree that beneficiaries may seek assistance from knowledgeable physicians, suppliers, providers, manufacturers, and attorneys in developing the individual's request for review. The individual is free to consult with these individuals and to follow those suggestions, recommendations, or advice. Thus, while these individuals may assist the beneficiary in navigating the adjudicatory process in an efficient manner, the beneficiary may not assign his or her legal right to request a review of an LCD or an NCD to a third party.

Comment: A commenter suggests that dually eligible Medicare and Medicaid beneficiaries have already assigned rights to third party payment to Medicaid agencies by virtue of sections 1902(a)(45) and 1912 of the Act, and Sec. 433.137 of the Medicaid regulations, and that States, therefore, should be allowed to participate in the process.

Response: We disagree with the commenter. The provisions of the Act and regulations cited concern the assignment of rights to seek medical support or payments and in providing information to assist the State in pursuing financially liable third parties. In contrast, a person initiating a challenge to an LCD or NCD is seeking to have a coverage policy held invalid and is not establishing a right to medical support or payment. Should a dually eligible beneficiary prevail in a policy challenge, a State may benefit in the
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claims adjudication process if it is determined that the policy was invalid. Furthermore, although this adjudicatory process is not available to a State directly, a State may always request
reconsideration of an LCD or NCD.

Dismissal of Complaint Upon Death of Beneficiary

Comments: We received comments about the proposed policy that would have dismissed complaints if the beneficiary died after initiating a section 522 challenge. Approximately one third of the commenters were opposed to this policy, and only one supported it. That commenter concluded that since the deceased would no longer be considered ``in need,'' it would be appropriate to dismiss the claim. The majority of those who commented objected to permitting an estate to appeal a claim without permitting the estate to continue a challenge to the policy that could determine the outcome of the appeal, thereby denying meaningful relief. One commenter indicated that the policy of automatic dismissal of a complaint upon death runs contrary to Federal common law that allows for the survival of remedial, as distinguished from penal or punitive, claims. In describing the burdens created by an automatic dismissal, the commenters referred to the potential for delay, the requirement to seek meaningful redress in Federal court rather than through the administrative appeals process, wasted resources expended prior to the death of the beneficiary in LCD/NCD challenges, and the potential for devastating financial burdens on the estates of deceased beneficiaries.

Response: We have revised the final rule to permit the estate of a beneficiary, as a successor in interest, to continue a challenge in those cases where the aggrieved party received the service and filed a timely complaint prior to death. In addition, we will allow an estate to initiate a challenge within 120 days of the issuance of a denial notice.

Acceptability of Complaints

Comments: Some commenters stated their belief that the complaint filing process in the proposed rule was overly complex. One commenter suggested that complaints should be deemed acceptable if sent to the ALJ, the local Social Security office, carrier or fiscal intermediary (FI), or the Board.

Response: We have revised the final rule to simplify and clarify the complaint filing procedures and to make them more beneficiary friendly. We have eliminated a number of requirements that we believe are unnecessary. However, it is the duty of the beneficiary to file the complaint correctly under these regulations. Nevertheless, we will issue instructions advising our contractors of procedures for a misdirected LCD/NCD complaint. These instructions will inform the contractor that it should forward the complaint to the proper location and notify the beneficiary.

Physician Certification

Comment: Some commenters stated that physician documentation of medical need is a reasonable way of determining whether beneficiaries have a basis for challenging LCDs/NCDs. However, other commenters felt that the physician certification requirements imposed unnecessary new paperwork burdens on physicians. Some commenters argued that it was unrealistic to require physicians to be certain of the intricacies of Medicare policies. Others felt these requirements would prove to be a significant impediment to the process and suggested that the original physician order for the service suffice as certification that the beneficiary needed the service. Finally, a number of commenters suggested that nonphysician practitioners should be allowed to document the beneficiary's need.

Response: We have revised the certification requirements at Sec. 426.400(c) and Sec. 426.500(c) in this final regulation by clarifying that the certification of need can be in the form of a written order for the service in question or other documentation in the medical record, thus significantly simplifying the certification requirements. We have also removed the requirement that the practitioner predict that payment would be denied. However, we continue to believe that the beneficiary's treating physiciannot any treating practitioneris best situated to determine ``in need'' status, both because he or she is the primary caregiver and also is responsible for the beneficiary's overall care.

Joint Complaints

Comments: We proposed permitting multiple parties to file a single complaint. We received one comment in support of the joint complaint option noting that it permits more effective resource utilization in addressing complaints. One commenter recommended that the criterion for joint complaints should not require ``a similar medical condition,'' rather that the adverse impact created by the LCD or NCD should create standing. Another commenter asserted that requiring a similar medical condition was unnecessary and inconsistent with the Federal Rules of Civil Procedure and that requiring a challenge to the same provisions of the same policy should be sufficient.

Response: In response to the comments concerning the requirement of a ``similar medical condition'' for the filing of a joint complaint, we believe that this requirement is reasonable, given the specific focus of these adjudications. Moreover, the Federal Rules of Civil Procedure are not controlling on our administrative proceedings. We believe that these procedures appropriately fit the specific requirements for LCD and NCD adjudications and are consistent with the Secretary's authority (42 U.S.C. 405(a)). Moreover, we do not eliminate the possibility of combining actions based upon different medical conditions if a party believes, and the ALJ/Board finds, that there are other bases for consolidating complaints.

Adjudicator Consolidation of Complaints

Comment: We received three comments on adjudicator authority to consolidate complaints. One commenter recommended merging the provisions for joint and consolidated complaints or, alternatively, having the provisions crossreference one another. Another commenter objected to the consolidation of complaints without the aggrieved party having reviewed the other complaint(s) to determine whether or not the consolidation might negatively impact the individual's specific issue with the LCD or NCD. Another commenter questioned whether the consolidation might result in lengthening the process if an adjudicator combined a later complaint with an earlier one.

Response: We believe that preserving the procedures for aggrieved parties to file joint complaints and for adjudicators to consolidate complaints promotes efficiency in adjudicating challenges to LCDs and NCDs. While we recognize that the two procedures support a common goal, we note that they are separate and distinct and therefore should remain in their respective sections. With respect to the comments concerning the possibility that a party might find consolidation adverse or burdensome, we believe it is appropriate for the adjudicator to determine whether consolidation is appropriate under the specific circumstances. We will allow any aggrieved party who feels disadvantaged by consolidation to raise these issues to the ALJ/Board. We have added language to Sec. 426.410(e) and Sec. 426.510(e) to [[Page 63697]]
clarify that the ALJ/Board may not consolidate complaints if doing so would unduly delay the ALJ/Board decision.

Amending a Complaint

Comment: Several commenters indicated that they were concerned that the proposed rule allowed a beneficiary to amend a complaint only once and then required the ALJ/Board to dismiss the challenge if the aggrieved party failed to submit an acceptable amended complaint.

Response: The statute requires that the section 522 challenge begin with the filing of a complaint. We believe that it would be inefficient if an aggrieved party had an unlimited number of attempts to file an acceptable complaint. A complaint is a significant document in identifying issues on appeal and leads to the production of the record. The final rule continues to allow the aggrieved party one opportunity to amend an unacceptable complaint before a time penalty is imposed. Withdrawal of ComplaintSixMonth Limit on Refiling

Comment: We received two comments in support of our proposal to establish a sixmonth limitation if an aggrieved party withdraws a complaint. One commenter was opposed, stating that if the aggrieved party has new evidence, he or she should be allowed to file another complaint regardless of the timeframe. We received two additional comments suggesting that, if the aggrieved party has new evidence, he or she should be allowed to file another complaint without a time limitation.

Response: We continue to believe that the sixmonth time limit is necessary to ensure the efficient use of scarce resources. If the aggrieved party withdraws a complaint, that aggrieved party must still wait six months before filing a new complaint on the same LCD/NCD. However, we have clarified that, once an acceptable complaint has been filed, if the aggrieved party identifies new evidence that was not available at the filing of the original complaint, the aggrieved party may submit that new evidence at any time without withdrawing and resubmitting the complaint.

Aggrieved Party Submitting a Brief

Comment: We received one comment suggesting that an aggrieved party should have the opportunity to submit a brief after the aggrieved party has had the opportunity to review the record upon which the LCD or NCD was based.

Response: We agree that an aggrieved party should have an opportunity to make his or her case. In seeking to make this process accessible to Medicare beneficiaries, who may or may not have legal representation, we did not want to mandate that parties submit legal briefs in support of their claims. However, in view of the changes we have made to the review process in this final rule, particularly for the introduction and use of new evidence, we are clarifying that, while briefs are not required in all cases, the adjudicator may request or permit the parties to submit written briefs and that the aggrieved party has the option to retain representation and to submit these written briefs.

Educating Beneficiaries and Providers About the Process

Comment: Many commenters stressed the importance of having a well constructed and advertised educational campaign for providers and beneficiaries. Some commenters suggested that a template for an acceptable complaint, a physician's certification, and an acceptable appeal of an ALJ's decision be available on the CMS Web site to assist beneficiaries in filing an acceptable complaint. Another commenter suggested that beneficiaries should be informed of their rights in the LCD or NCD review process and that one means of providing this might be to include it with advanced beneficiary notice (ABN) forms. Another commenter encouraged us to inform beneficiaries clearly as to their financial obligations while the complaint is pending. Several other commenters suggested that we provide model language for use by Medicare managed care organizations to use in their evidence of coverage documents.

Response: In the proposed rule (67 FR 54547), we explained our intent to produce a userfriendly guide that beneficiaries may use in accessing the section 522 process. We will work with the ALJs and Board to develop educational materials to inform the public of
(1) The elements of an acceptable complaint;
(2) The standards for treating physician certifications; and (3) The elements of an acceptable appeal of an ALJ decision. We intend to prepare this educational material (including templates) and make it publicly available, but we will not delay implementation of the final rule to wait for these materials to be developed. We will work with ALJs and the Board to make available to Medicare managed care organizations and Medicaid State agencies, relevant information on complaints and decisions. We do not intend to revise ABNs as part of this educational program.

Allowing Participation by Interested Entities

Comment: Several commenters believed that we should allow for more public participation of interested entities in the process, along with submission of evidence by those parties.

Response: The LCD and NCD reconsideration processes currently exist to give all interested entities the right to request and participate in reconsiderations of these policies. These processes will continue to exist to provide an avenue for all interested entities to submit evidence that they consider pertinent. In contrast, the adjudicatory process created by section 522 is initiated only by a beneficiary in need of coverage, and not by all interested individuals. We are concerned that allowing any member of the public to submit evidence would make these adjudicatory proceedings unwieldy. We are modifying this final rule at Sec. 426.513, however, to permit participation as amicus curiae, in the NCD process. We recognize that NCD reviews may impact a large number of stakeholders apart from the aggrieved parties initiating the review. We believe that the nationwide effect of an NCD review decision requires public notice and opportunities for input in a way that LCD reviews do not. In addition, this impact may be significant, even where no change to existing policy results from the review, such as when the Board concludes that an NCD record is complete and contains adequate information to support the validity of the NCD.

Anyone who has information that can assist the Board in reviewing an NCD challenge is permitted to request participation as an amicus curiae. Given the nationwide effect of an NCD review decision, the process must strike a careful balance between providing reasonable opportunities for input by those who may ultimately be substantially affected by any decision, and creating a workable process to address the issues presented by the aggrieved party seeking review. Because of the regional nature and high number of LCDs, allowing the opportunity for amicus curiae participation in the review of LCDs would create an inefficient process. However, at any time, any party within the contractor's jurisdiction who wishes to bring forward new evidence relating to a policy may do so through the contractor's LCD reconsideration process. This process is frequently used
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and is an efficient method to bring new evidence to the contractor's attention.
Making NCD Complaints and Documentation Available and Announcing the Proceedings

Comments: A number of commenters suggested that all interested parties should have notice of an LCD/NCD complaint and have the opportunity to participate in the proceedings. One commenter recommended the use of an online docketing system whereby the public could learn of LCD/NCD challenges and determinations made by the ALJs and Board in these cases.

Response: The statute does not require that we develop such a nationwide online docketing system. While the concept is interesting, an online docketing system is beyond the scope of this regulation. Currently, we are exploring options for the best way to docket and track challenges.

Changes in NCDs may determine the health care services, technologies, and treatments to which beneficiaries have access. The denial of coverage for a service that is allegedly reasonable and necessary may have an adverse impact on others across the nation. Hence, it is important that the review decisions are based on a comprehensive and welldeveloped record.

In addition, the general public may have a substantial interest in the outcome of some NCD reviews. NCD review decisions will constitute a legal precedent with respect to the outcome. Board decisions will clarify the extent of available Medicare coverage.

Therefore, under the final rule, the Board will make available to the public information about all NCD complaints by means of posting on the Internet. This method will provide the broadest possible public notice, without unreasonably delaying review of the complaint already filed. Any request to participate as an amicus must then generally be filed within the timeframes set by the Board.

Although LCDs are also important, LCDs are regional in nature. Because LCD reviews generally impact only a limited geographic area, we will not require the ALJs to make public all LCD complaints. Notice to Managed Care Organizations (MCOs) and State Agencies

Comment: Several commenters suggested that Medicare managed care organizations (MCOs) and State agencies receive timely notification when a challenge is filed at each stage of review, when an ALJ/Board decision is made, and when a revised LCD/NCD is effective. One commenter suggested that the regulation be revised to require the ALJ or the Board to notify MCOs when an enrollee challenges an LCD/NCD.

Response: We will work with the ALJs and the Board to make available to MCOs and State agencies, relevant information about complaints and decisions.

Mediation

Comment: We received one comment for and one comment against using mediation in an evidencebased review process.

Response: We have added a provision authorizing the Board to stay the review proceedings for a reasonable time when all parties voluntarily engage in settlement negotiations, with or without the assistance of an impartial mediator. In general, we do not consider it appropriate to negotiate about clinical issues that affect the health or safety of Medicare beneficiaries. In some instances, however, it may be worthwhile to explore alternative and less costly means of resolving a dispute. Mediation may be useful to narrow the issues in dispute in order to make the review process more efficient. Using alternative means of resolving disputes is consistent with the Federal Administrative Dispute Resolution Act and HHS policy. Under this final rule, the ALJ or the Board could not compel mediation. Where the parties consent to mediation, the ALJ or the Board may provide an impartial mediator or assist the parties in finding an impartial mediator acceptable to them.
Automatic Dismissal When a Contractor Retires an LCD or CMS Withdraws an NCD

Comments: One commenter agreed that, if an NCD is withdrawn, the purpose for the review has been eliminated and the claims can be adjudicated without consideration of the repealed NCD, but objected to the statement that the repeal will have the same effect as a decision under Sec. 426.560(b). The commenter, however, interpreted section Sec. 426.560(b) as permitting a contractor to continue to rely on a withdrawn NCD.

Response: Retiring an LCD or withdrawing an NCD would result in the retired/withdrawn policy no longer applying in the claims adjudication process for services rendered on or after the date that the policy is retired/withdrawn. Moreover, the aggrieved party would be granted individual claim review. Since a claimant would receive the same relief that would have been available had the adjudicator found that the relevant LCD or NCD was not valid, there would be no reason to continue the appeal.

Comment: One commenter recommended against automatic dismissal if a policy were retired or withdrawn. As an alternative, the commenter suggested giving the adjudicator discretion to dismiss ``where the decision normally occurs'' and opined that since a retired or withdrawn policy may be reconsidered or reaffirmed, the automatic dismissal provision effectively nullifies the entire policy appeal process.

Response: When we retire/withdraw an LCD/NCD we will not apply those policies for services furnished after the retirement/withdrawal date and we will reprocess the aggrieved party's affected claims without applying the retired/withdrawn policy. If, in the future, the contractor or CMS issues a new LCD/NCD on that subject the change would be adopted after an opportunity for public comment. Any such change would be prospective in nature, and a new LCD/NCD would be subject to challenge under this final rule.

Comment: Two commenters indicated that automatic dismissal would not permit an ALJ's or the Board's findings to be used in the appeal of claims decisions based upon the invalidated policy.

Response: Because the ALJ or the Board would not be required to make a decision in a case where the contractor/CMS retired/withdrew the LCD/NCD, there would be no Board decision with precedential effect. However, we believe our approach conserves resources for all parties and adjudicators.

Timeline for Beneficiary Getting the LCD/NCD Record

Comment: We received one comment on the timing of the LCD/NCD record production requirement. That commenter suggested that we should create a 45day response timeframe to ensure that the review process proceeds without inordinate delays.

Response: We agree that the establishment of timeframes will promote the efficiency of the BIPA 522 process. However, we believe that the time required will vary with the size and scope of the record requested. Therefore, we have revised the final rule at Sec. 426.410(d) and Sec. 426.510(d) to state that the contractor or CMS must generally produce the record within 30 days, subject to extension for good cause shown.
Timeline for an Aggrieved Party to Review the LCD or NCD Record

Comment: One commenter suggested that 30 days might not be enough time
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for the aggrieved party to review the record, particularly for an individual pursuing a complaint with minimal outside assistance. The commenter recommended a 45to60day timeframe for the aggrieved party to respond.

Response: We accept the commenter's suggestion to increase the time for review of the record. While we have maintained the 30day timeframe, we have added an exception for good cause shown, for review and response to the relevant LCD or NCD record, if additional time is required.

No Evidence To Support an LCD/NCD

Comment: We received several comments stating that where no record exists to support an LCD/NCD, the beneficiary should not have to introduce new evidence.

Response: We expect it would be a rare event that no record exists. In that rare event, we agree with the commenter. We have made changes to clarify that, in the rare event that no evidence exists to support an LCD or NCD, we will either voluntarily retire/withdraw the policy, or request the ALJ/Board to strike down the applicable provision(s) of the policy, whichever is the more expeditious option.

New Evidence

Comment: Approximately half of the commenters made comments on the issue of new evidence. Most of the comments stated that allowing us to have an automatic stay, coupled with the absence of specific deadlines, would unduly delay the review process. Other commenters suggested that the stay should be a matter of ALJ/Board discretion. Numerous comments specifically requested that the ALJ or Board review all evidence, including new evidence, to allow for a more efficient process.

Response: We agree that a more efficient and timesensitive adjudicatory process is important, and we have addressed several aspects of these comments in the final rule. We have taken considerable steps to create an efficient adjudicatory process that still preserves the important role of the clinical and scientific experts in making LCDs and NCDs.

We have eliminated the proposed automatic stay when new evidence is submitted. Instead, our final rule will require that, if new evidence has been received by the ALJ/Board that would otherwise be admissible, the ALJ/Board will review the new evidence after the period for discovery and the taking of evidence is complete, and decide if it has the potential to significantly affect the LCD/NCD provision in question. If not, the review will continue. If the ALJ/Board determines that the new evidence has the potential to significantly affect the validity of the LCD/NCD, the ALJ/Board will stay the proceedings and forward the material to the contractor or to us for a brief review. The contractor/CMS will have 10 days to provide a statement indicating whether or not: (1) A reconsideration will be initiated, or (2) the policy will be revised or retired/withdrawn. If the Agency undertakes a reconsideration, it must be completed within a period set by the ALJ/ Board that is not more than 90 days. We believe this 90day timeframe is reasonable due to the potentially large body of evidence that must be reviewed. Following a reconsideration, the contractor/CMS will prepare and submit the new LCD/NCD record, and the ALJ/Board proceedings will continue on the revised LCD/NCD. If the contractor/CMS chooses not to initiate a reconsideration, the ALJ/Board proceedings will continue on the original LCD/NCD as supplemented with the new evidence. The aggrieved party will have an opportunity to submit a statement about whether the record still fails to support the validity of the LCD/NCD. The contractor/CMS will have an opportunity to respond. No further evidence will be taken at this stage, and the ALJ/Board will proceed to make a determination on the merits.

We have also made changes to the definition of ``new evidence'' to clarify that new evidence means evidence that was not considered by the contractor or CMS.

When Does the Review Stop?

Comments: In the proposed rule, we specifically asked for comments on alternatives for structuring the review process. We proposed to divide the decision making process for cases at the ALJ/Board level into two stages and thereby establish the prerequisites for discovery under the statutory framework set forth at section
1869(f)(1)(A)(iii)(I) and section 1869(f)(2)(A)(i)(I) of the Act. Under the proposed regulation, in order to obtain discovery, a challenger was required to first file a motion with the Board or ALJ alleging that the record was incomplete or lacked adequate information to support the validity of the determination. Only if the record was incomplete or otherwise inadequate would an aggrieved party be able to pursue discovery. Even if the challenger did not file such a discovery motion, however, a beneficiary could seek a decision on whether the determination was based on reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law.

We outlined another possible approach in our proposed rule at 67 FR 54542. That approach would require a party to file a statement regarding whether that party considers the record complete and adequate, and an ``offer of proof'' supporting factual allegations about incompleteness. The adjudicator would then decide whether the record is complete and adequate to support the decision and would prepare a written decision. If the adjudicator found that the record was complete and adequate, this decision would be a final Agency action appealable to the court.

There were two public comments on this issue. One commenter suggested that, if the adjudicator found that the record was incomplete or inadequate, the Board would be legally required to determine that the ``NCD is not reasonable.'' This commenter believed that the Board would be precluded from allowing discovery or any other new evidence at this point, but must automatically rule against CMS. A commenter appeared to prefer the following approach: ``If, upon review of the record, the aggrieved party does not have objections to the completeness or adequacy of the LCD or NCD record, then what is the basis of the aggrieved parties complaint? Presumably the coverage policy would be challenged on the basis that it is inconsistent with current clinical or scientific evidence. In such case, a motion by the aggrieved party would appear to be a necessary part of the complaint process and an appropriate step given the limited time and resources of adjudicators, CMS and contractors.'' The commenter ``believed that the aggrieved party should challenge the completeness or adequacy of the record before an adjudicator should make a determination with respect thereto.''

Response: We have reexamined our proposed procedures in light of the public comments and the unique statutory language in section 1869(f)(1)(A)(iii)(I) and section 1869(f)(2)(A)(i)(I) of the Act. In this final rule, we clarify at Sec. 426.400 and Sec. 426.500, the procedural and substantive steps involved in the appeal. The revised procedures incorporate approaches from both alternatives discussed in the proposed rule. We believe that the revised procedures are fair, consistent with the statutory framework, and will enable the ALJs and Board to fairly resolve challenges to LCDs and NCDs in an expeditious manner.

The administrative review provisions in BIPA section 522 are unique. While
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the reviews are, at the outset, based on the medical and scientific evidence that the contractor/CMS considered in issuing the LCD/NCD, and the statute requires that the adjudicator ``shall review the record,'' it does permit discovery in some limited circumstances and also permits that adjudicator to consult with ``appropriate scientific and clinical experts.'' Obviously, new evidence obtained through discovery or testimony could not have been considered by the agency when the policy predates the new evidence. Thus, the procedures are not entirely based on the record, but new evidence and testimony may influence the ALJ's/ Board's decision in some cases.

It is possible that an aggrieved party would attempt to challenge an LCD/NCD for several reasons. For instance, a challenger may believe that a policy that was correct when it was issued has become outdated and is no longer valid in light of advances in medicine. Those challengers may be most interested in presenting new medical evidence in support of changing the policy rather than challenging the original factual basis for the policy. As noted previously, we are modifying our procedures to allow a party to submit new evidence to the ALJ/Board. We have modified the procedures at Sec. 426.340 to allow the ALJ/Board to make a preliminary determination on whether the new evidence submitted would have a significant bearing on the validity of the LCD/NCD. If the evidence is found significant, it would be sent to the contractor/CMS to determine whether the contractor/CMS agrees that the evidence warrants a formal reconsideration. As mentioned earlier, the reconsideration process would be time limited but would allow the public to submit medical and scientific evidence and allow the agency to fully develop the record in light of advances in medical science. Following the timelimited reconsideration, a supplemental record would be filed and the adjudication could continue, if necessary.

This approach will provide the contractor/CMS the initial opportunity to permit medical and scientific experts to examine the new evidence and to make findings of fact concerning the new evidence. Among other things, the statute requires that the ALJ/Board ``shall defer only to the reasonable findings of fact'' and it was impossible for the agency to have made findings on evidence that did not yet exist or that had not been furnished to the agency for consideration. We believe this approach is necessary to ensure that the medical and scientific opinions of the agency experts illuminate the record, since these appeals could involve very technical medical and scientific material related to the new evidence.

While it is possible that the challenger may submit credible medical and scientific studies that warrant a formal reconsideration, it is also possible that the evidence submitted would not be either relevant or persuasive, or that a challenger may seek to challenge the policy on other grounds. Because the public comments have highlighted the different types of disputes that may be presented, we have modified our procedures in attempt to fairly, yet expeditiously, resolve any type of challenge that may be presented. Our revised approach would allow the ALJ or the Board to resolve some cases without need for a reconsideration and would also allow the review proceedings to be resolved in a more expeditious manner. To resolve any confusion, we will describe the significant procedural and substantive steps of the review.

Under the revised procedures at Sec. 426.425 and Sec. 426.525, all aggrieved parties, after reviewing the LCD or NCD record, will be able to file a statement that includes the challenger's arguments as to why the record is not complete, or not adequate to support the validity of the LCD/NCD under the reasonableness standard. This may be the most important step in the review process from the aggrieved party's perspective because this is the opportunity to present any arguments for the LCD/NCD being held invalid. (See Sec. 426.425(a), Sec. 426.525(a)). CMS or the contractor will have 30 days to submit a response to this statement. (See Sec. 426.425(b), Sec. 426.525(b)).

After evaluating the materials and the record, our revised procedures will permit the ALJ/Board to make a prompt decision in the nature of a summary judgment if the case warrants this approach. For instance, if applying the reasonableness standard, the adjudicator finds that record is complete and has adequate information to support the validity of the LCD or NCD, the ALJ or the Board may issue a decision that ``the record is complete and adequate'' to support the policy. (See Sec. 426.425(c)(1), and Sec. 426.525(c)(1)). For cases involving an NCD, the aggrieved party would have the right to challenge this final agency action in Federal court. (Section 1869(f)(1)(A)(v) of the Act). For cases involving an LCD, the aggrieved party would have the right to challenge the ALJ's decision at the Board, and potentially in Federal Court. (Sec. 426.465).

If, on the other hand, after evaluating the materials submitted by the parties and the record, the ALJ/Board determines that the record is not complete or not adequate to support the validity of the LCD/NCD, the adjudicator will permit discovery and the taking of evidence. Following discovery and the taking of evidence as set forth in these final rules, the ALJ/Board will issue a final decision. (See Sec. 426.447, Sec. 426.547). Those final decisions may also be appealed in appropriate circumstances.

Although we recognize that one commenter suggested that the ALJ or the Board would be legally required to hold invalid the LCD/NCD rather than allowing the agency to supplement the record, the case cited is not relevant given the unique language and history of BIPA section 522. The ALJs and the Board are not acting as a Federal court reviewing final agency action. The case relied on by the commenter concerned the scope of review under the judicial review provisions of the Administrative Procedure Act, 5 U.S.C. 706. Moreover, under prior provisions for court review of NCDs, even courts were required to permit us to supplement the record before declaring an NCD invalid. We believe our approach is consistent with the specific requirements of the statute.

Scope and Weight of Evidence

Comment: One commenter believed that the proposed rule would have the effect of excluding highly relevant information such as physicians' standards of practice and their professional opinions from the review process. Another commenter believed that we should define the hierarchy of evidence strength to assure proper weighting by the ALJ or Board when considering scientific and clinical information.

Response: We are not accepting the recommendation to include a hierarchy of evidence in order to allow flexibility in analyzing evidence. We recognize that many types of evidence have value, and will consider clinical experience, as well as other forms of medical, technical, and scientific evidence in making LCDs and NCDs. We note that the ALJ/Board may seek input from clinical and scientific experts at their discretion. There is no prohibition against the ALJ or the Board seeking the input of practicing physicians or considering standards of practice.

Discovery

Comment: We received several comments on the nature and scope of discovery. One commenter supported the limitation upon discovery that [[Page 63701]]
would allow contractors to produce existing records rather than requiring them to develop and produce new documentation.

Response: We appreciate the commenter's support of our proposals and have taken its views into account in considering the comments of those commenters who recommended revisions.

Comment: One commenter objected to our proposal not to initiate discovery between parties until after an adjudicator has made a determination about the adequacy of the record. The commenter suggested that discovery should be available any time after the complaint is filed.

Response: We note that the statute establishes the timing of discovery. Section 186

FOR FURTHER INFORMATION CONTACT Vadim Lubarsky, 410-786-0840 for National Coverage Determinations. Misty Whitaker, 4107863087 for Local Coverage Determinations.