[Federal Register Volume 66, Number 208 (Friday, October 26, 2001)]
[Notices]
[Pages 54253-54255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26289]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMSR-3080-NR]


Medicare Program; the National and Local Coverage Determination 
Review Process for an Individual With Standing as Defined in Section 
522 of the Medicare, Medicaid, and SCHIP Benefits Improvement and 
Protections Act of 2000

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice of CMS Ruling.\1\

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    \1\ Editorial Note: Future CMS Rulings may appear in the Rules 
Section of the Federal Register if they are interpretations of or 
general policy statements concerning CMS rules (See 1 CFR 5.9(b)).
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SUMMARY: This notice announces a CMS Ruling concerning the appropriate 
actions to be taken upon receipt of a complaint seeking review of a 
national or local coverage determination under section 522 of the 
Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act 
of 2000, Public Law 106-554. The Ruling establishes the interim 
administrative procedures that CMS contractors, and Administrative Law 
Judges (ALJs) are to follow in processing such complaints until final 
regulations are published regarding the adjudication of the complaints 
and the effectuation of ALJ and Departmental Appeals Board decisions 
with respect to complaints.

FOR FURTHER INFORMATION CONTACT: Jim Bossenmeyer, (410) 786-9317.

[[Page 54254]]


SUPPLEMENTARY INFORMATION: The CMS Administrator signed Ruling CMSR-01-
1 on September 24, 2001. The text of the CMS Ruling follows: The 
National and Local Coverage Determination Review Process for an 
Individual with Standing as Defined in Section 522 of the Medicare, 
Medicaid, and SCHIP Benefits Improvement and Protections Act of 2000.
    Summary: Under section 1869(f)(5) of the Social Security Act (the 
Act), as added by section 522 of BIPA, effective October 1, 2001, 
certain individuals (``aggrieved parties'') may file a complaint to 
initiate a review of a national or local coverage determination. 
Complaints filed under section 1869(f) of the Act concerning national 
coverage determinations are to be reviewed by the Departmental Appeals 
Board (DAB) of the Department of Health and Human Services; complaints 
filed under section 1869(f) of the Act concerning local coverage 
determinations are to be reviewed by ALJs of the Social Security 
Administration. The purpose of this Ruling is to establish the interim 
administrative procedures that CMS contractors, ALJs, and the DAB are 
to follow in processing such complaints until final regulations are 
published regarding the adjudication of the complaints and the 
effectuation of ALJ and DAB decisions with respect to complaints.
    Citations: Section 1869 of the Social Security Act (42 U.S.C. 
1395ff), and section 522 of the Medicare, Medicaid, and SCHIP Benefits 
Improvement and Protections Act of 2000, Pub. L. 106-554 (2000).

Background

    Section 522 of BIPA amends section 1869 of the Act to create a new 
administrative review process that enables certain beneficiaries to 
challenge CMS Medicare policies, commonly referred to as national 
coverage determinations (NCDs) and local coverage determinations 
(LCDs). These administrative challenges are distinct from the existing 
appeal rights for the adjudication of Medicare claims.
    Prior to BIPA, there was no administrative mechanism for any party 
to challenge a coverage policy. Section 1869(b)(3) of the Act, however, 
provided a remedy for judicial review of NCDs based on section 
1862(a)(1) of the Act, that is, determinations as to whether an item or 
service is reasonable and necessary. Section 1869(f) of the Act 
requires that CMS establish an administrative review process for NCDs 
and LCDs. Under the statute, beneficiaries who are in need of a service 
that is the subject of a coverage determination may challenge an NCD in 
an administrative proceeding before the Departmental Appeals Board 
(DAB). Similar provisions allow aggrieved parties to challenge LCDs 
before an ALJ. An aggrieved party dissatisfied with the ALJ's decision 
may seek review by the DAB. In this type of appeal, the DAB acts as an 
appellate body. The decision of the DAB relating to an LCD challenge or 
an NCD challenge becomes a final agency action and is subject to 
judicial review.
    The effective date for these provisions is October 1, 2001. Section 
521 of BIPA sets forth additional changes to our existing claim appeals 
process that are to take effect on October 1, 2002.

Delay of Reviews Under Section 1869(f)

    Section 522(d) of BIPA establishes an effective date of October 1, 
2001 for new section 1869(f) of the Act. Although the statute thus 
permits aggrieved parties to file complaints with respect to NCDs and 
LCDs beginning October 1, 2001, we believe it is clearly in the public 
interest to complete notice and comment rulemaking to develop the rules 
and procedures for adjudicating these policy challenges. Notice and 
comment rulemaking will ensure that the public has an opportunity to 
fully participate in the development of these rules. It also will 
ensure that the DAB and the ALJs have a uniform adjudicative process 
for resolving these issues in a fair and efficient manner.
    It is essential that these complaints be handled in a uniform 
manner for several reasons. First, the coverage determinations to be 
reviewed under the provisions of section 1869(f) of the Act apply to a 
broader group of beneficiaries than just the individual beneficiary who 
has raised the complaint. NCDs apply to all claims nationwide for the 
particular item or service in question and are binding on both the 
Medicare contractors and the ALJs who hear individual claims appeals. 
LCDs apply to beneficiaries within the jurisdiction specified by the 
contractor and are binding on the contractors making claims 
determinations. Due to the broad impact of these policies, review of 
these policies must be done in a consistent, predictable manner. It is 
important to establish final regulatory guidance on these provisions 
with the benefit of public notice and comment before the provisions are 
fully implemented. For example, regulatory guidance is necessary to 
ensure that the provisions identifying those beneficiaries with 
standing to file a complaint about an NCD or LCD are interpreted 
consistently and that consistent remedies be available to beneficiaries 
whose challenge to a coverage determination is successful.
    In addition, the coverage determination reviews are a new 
responsibility for the ALJs and the DAB. We believe that establishing a 
consistent system for handling these reviews from the beginning will 
enable these entities to process this additional workload as 
efficiently as possible.
    Therefore, to ensure consistent handling of NCD and LCD review 
requests and to ensure that all aggrieved parties are afforded equal 
rights and protections, CMS is delaying full implementation of section 
1869(f) of the Act until final regulations are issued. This delay will 
avoid inefficient and ad hoc proceedings that could occur if each 
contractor, ALJ, and the DAB establish separate procedures.

Restrictions on Medicare Contractors in Absence of a Regulation

    Until a final regulation is issued that fully implements section 
1869(f) of the Act, carriers, fiscal intermediaries, and program 
safeguard contractors (PSCs) must not provide or furnish any materials, 
information, background, or any other pertinent information regarding 
the development or implementation of an NCD or LCD to either the DAB or 
an ALJ. Instead, any request for NCD or LCD documentation from the DAB 
or an ALJ should be referred immediately to the appropriate contact in 
the CMS central office (see below). Furthermore, if an administrative 
decision requiring the carrier, fiscal intermediary, or PSC to take any 
action with respect to a specific NCD or LCD is issued, the contractor 
must refer this request to CMS central office before taking any action.

Medicare Contractor Administrative Process for Any Reviews of 
National or Local Coverage Determinations

    If a complaint under section 1869(f) of the Act is filed with a 
carrier, fiscal intermediary or PSC requesting a review of a national 
or local coverage determination under section 1869(f) of the Act, the 
carrier, fiscal intermediary, or PSC must within 10 business days, 
forward a complaint concerning an LCD to SSA's Office of Hearings and 
Appeals and a complaint concerning an NCD to the DAB at the addresses 
below. After forwarding the complaint to the Office of Hearings and 
Appeals or DAB, the contractor must notify the appropriate contact in 
the CMS central office and provide them a copy of the complaint.

LCD Referral

Office of Hearings and Appeals

[[Page 54255]]

Social Security Administration
One Skyline Tower
Suite 1702
Attention: LCD Complaint
5107 Leesburg Pike
Falls Church, Virginia 22041

NCD Referral

Department Appeals Board
U.S. Dept. of Health and Human Services
Room 637D, Humphrey Building
Attention: NCD Complaint
200 Independece Avenue, SW.
Washington, DC 20201

Administrative Review Process With Respect to NCDs or LCDs

    If a complaint under section 1869(f) of the Act is filed with or 
forwarded to the DAB or an ALJ, the DAB or ALJ will:
    (1) Within 10 business days, send a written response to the 
requestor informing them that the review process for the complaint is 
being delayed under this Ruling, and that the Department of Health and 
Human Services intends to publish regulations establishing uniform 
procedures.
    (2) Docket any such requests.
    (3) Inform the CMS of any requests received. (This should be 
accomplished by sending a copy of the complaint to the appropriate 
notification contact.)

LCD Notification Contact

Melanie Combs
7500 Security Blvd.
C3-02-16
Baltimore, MD 21244-1850
Attention: LCD Challenge Staff
Telephone Number: (410) 786-7683

NCD Notification Contact

Vadim Lubarsky
7500 Security Blvd.
C1-10-23
Baltimore, MD 21244-1850
Attention: NCD Challenge Staff
Telephone Number: (410) 786-0840

    (4) Take no further action until final regulations are effective.
    Once the regulation is effective, inform the requestor that 
processing of complaints under the new review procedures will continue.


    Authority: Section 1869 of the Social Security Act (42 U.S.C. 
1395ff), and section 522 of the Medicare, Medicaid, and SCHIP 
Benefits Improvement and Protection Act of 2000, Pub. L. 106-554.

(Catalog of Federal Domestic Assistance Program No. 93.773 
Medicare--Hospital Insurance Program; and No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: October 2, 2001.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 01-26289 Filed 10-25-01; 8:45 am]
BILLING CODE 4120-01-P