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Please
note: Contractor 00454 – Alaska, American Samoa, Arizona, California
(entire state), Guam, Hawaii, Idaho, Nevada, Oregon, Washington and
Northern Mariana Islands - applies to RHHI only.
NOTE: Requests that do not meet
the requirements below will be returned to the sender as invalid
requests. If your request or comment does not meet the requirements
listed below, please do NOT submit as an LCD reconsideration
request. DO contact the National Government Services Provider
Outreach and Education Department at (800) 338-6101 for
assistance.
Note: The requirements in this article are
based on instructions found in CMS Publication 100-08, Medicare
Program Integrity Manual, Chapter 13, Section 7.1 and 11. All
language in italics is quoted verbatim from that same
source.
The LCD Reconsideration Process is a mechanism by
which interested parties can request a revision to an LCD. In order
to be considered a valid request, the requirements listed in the
following sections must be met. Any request for LCD reconsideration
that, in the judgment of the National Government Services, does not
meet these requirements is invalid.
Qualified
Requests
National Government Services will consider
all LCD reconsideration requests from:
- Beneficiaries residing or receiving
care in[our]
jurisdiction (Alaska, American Samoa, Arizona, California,
Connecticut, Delaware,Guam, Hawaii, Illinois, Indiana, Idaho,
Kentucky, Maine, Massachusetts, Michigan, Nevada, New Hampshire,
New Jersey, New York, Northern Mariana Islands, Ohio, Oregon,
Vermont, Virginia, Washington, West Virginia and
Wisconsin);
- Providers doing business
in [our]
jurisdiction; and [from]
- Any interested party doing business
in [our]
jurisdiction.
Appropriate
Subjects
The LCD Reconsideration Process
is available only for final LCDs. The whole LCD or any part of the
LCD may be reconsidered. Requests are not accepted for other
documents including:
▪ National Coverage Decisions (NCDs)
[for example, Medicare Coverage Issues Manual policies] (See
section below for additional information.);
▪ Coverage
provisions in interpretive manuals [for example, instructions
found in the Medicare Hospital Manual];
▪ Draft
LCDs;
▪ Template LCDs, unless or until they are adopted by
the contractor;
▪ Retired LCDs;
▪ Individual
claim determinations;
▪ Bulletins, articles, training
materials; and
▪ Any instance in which no LCD exists
[for example, requests for development of an
LCD].
National Coverage Determination Reconsideration
Requests
If modification of the LCD would conflict
with an NCD, the request [is] not valid. To request
reconsideration of National Coverage Determinations, please refer to
the NCD reconsideration process instructions found on the Medicare
Coverage Home Page at http://www.cms.hhs.gov/center/coverage.asp.
Interested parties should submit national coverage requests and
national coverage reconsideration requests through the CMS Web site
(http://www.cms.hhs.gov/DeterminationProcess/02_howtorequestanNCD.asp)
or in writing to: Coverage and Analysis Group, Centers for Medicare
& Medicaid Services, 7500 Security Blvd. (Mailstop C1-09-06),
Baltimore, MD 21244.
Information to be
Submitted
The request must be submitted in writing
and must identify the language that the requestor wants added to or
deleted from the LCD. Requests shall include a justification
supported by new evidence, which may materially affect the LCD’s
content or basis. When articles or textbooks are cited,
copies of the published documents must be included.
The
level of evidence required for LCD reconsideration is the same as
that required for new/revised LCD development. As described in
the Medicare Program Integrity Manual, LCDs are to be based
on the strongest evidence available. In order of preference, LCDs
are based on:
Published authoritative evidence derived
from definitive randomized clinical trials or other definitive
studies General acceptance by the medical community (standard of
practice), as supported by sound medical evidence based on:
- Scientific data or research studies
published in peer-reviewed medical journals; [or]
- Consensus of expert medical opinion
(i.e., recognized authorities in the field); or
- Medical opinion derived from
consultations with medical associations or other healthcare
experts.
Acceptance
by individual healthcare providers, or even a limited group of
healthcare providers, normally does not indicate general acceptance
by the medical community. Testimonials indicating such limited
acceptance, and limited case studies distributed by sponsors with
financial interest in the outcome, are not sufficient evidence of
general acceptance by the medical community. The broad range of
available evidence will be considered and its quality shall be
evaluated before a conclusion is reached.
Submission
Process
Qualified parties who request LCD
reconsideration must submit a written request that includes the
following items:
- name and address;
- telephone
number (optional);
- e-mail
address (if applicable);
- name and
address of the organization he/she represents and the nature of
that organization’s business if the requestor is neither a
beneficiary nor a provider;
- and name of the LCD.
(LCD
reconsideration requests are to be submitted as noted below.
Unrelated inquiries may result in a delayed response. (Please refer
to the http://www.ngsmedicare.com for further contact information.)
Please send LCD reconsideration written requests
to:
National Government Services, Inc.
Medical Policy Unit
Attn: Gina Oliveri, RN - LCD Reconsideration Requests
P.O.
Box 7149
Indianapolis, IN 46207-7149
Requests are best
submitted electronically via e-mail to:
E-mail:
NGS.lcd.reconsideration@anthem.com
or
Fax: (888)
605-8802
NOTE: Justification supported by new evidence,
which may materially affect the LCD’s content or basis, is required
for all LCD reconsideration requests, including those made by
e-mail, online form, and fax.
NOTE: Requestors must
ensure that the sending of Medicare beneficiary HIC numbers,
Medicare provider numbers or any other individually identifiable
health information is compliant with the privacy provisions found in
HIPAA.
National Government Services
Response
Within 30 days of the day the request is
received, National Government Services will determine whether the
request is valid or invalid and will notify the requestor of that
determination. If the request is invalid, we will explain why it was
invalid.
If the request is valid, within 90 days of the day
the request is received, the National Government Services will make
a reconsideration decision and will notify the requestor of the
decision and the rationale for the decision. Decision options
include: no revision; revision to a less restrictive policy;
considering revision to a more restrictive policy; or retiring the
policy.
If the decision is to revise to a less restrictive
policy, the revised policy will be published on the Medicare
Coverage Database (http://www.cms.hhs.gov/mcd) and the National
Government Services Web site (http://www.ngsmedicare.com). The
effective date will be specified in the revised policy.
If
the decision is to consider revision to a more restrictive policy,
the National Government Services will subject the proposed revision
to the formal LCD development process, including a formal advice and
comment period.
If the decision is to retire the policy,
notice of this will be published on the Medicare Coverage Database
(http://www.cms.hhs.gov/mcd) and the National Government Services
Web site (http://www.ngsmedicare.com). The termination date of the
policy will be specified in the retired policy. |