LCD Reconsideration Process
The Local Coverage Determination (LCD) Reconsideration Process is a mechanism by which interested parties can request a revision to an LCD. The LCD Reconsideration Process is available only for final LCDs. The whole LCD or any provision of the LCD may be reconsidered; Noridian may revise or retire their LCDs at any time on their own initiative.
Noridian will consider all LCD reconsideration requests from:
- Beneficiaries residing or receiving care in the Noridian jurisdiction
- Providers doing business in the Noridian jurisdiction
- Any interested party doing business in a contractor's jurisdiction
Noridian will only accept reconsideration requests for LCDs published in final form. Requests will not be accepted for other documents including:
- National Coverage Decisions (NCDs)
- Coverage provisions in interpretive manuals
- Draft LCDs
- Template LCDs, unless or until they are adopted by the contractor
- Retired LCDs
- Individual claim determinations
- Bulletins, articles, training materials
- Any instance, in which no LCD exists, i.e., requests for development of an LCD
If modification of the LCD would conflict with an NCD, the request would not be valid. Noridian directs requestors to the NCD reconsideration process on the CMS Medicare Coverage Determination Process webpage.
The following steps MUST be followed to submit LCD reconsideration requests.
| Noridian JE Part B |
Attn: LCD Reconsideration
PO Box 6781
Fargo ND 58108-6781
|Fax|| Noridian JE Part B |
Attn: LCD Reconsideration
| Attn: LCD Reconsideration |
The request must identify the language that the requestor wants added to or deleted from an LCD. Requests shall include justification supported by new evidence, which may materially affect the LCD content or basis. Copies of published evidence shall be included.
The level of evidence required for LCD reconsideration is the same as that is required for new/revised LCD development Internet Only Manual (IOM), Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.7.1.
Any request for LCD reconsideration that, in the judgment of the contractor, does not meet these criteria is invalid. Noridian may consolidate valid requests if similar requests are received.
Reconsideration requests shall be based on the strongest evidence available. The documentation of the extent and quality of supporting evidence will facilitate a review of the case. In order of preference, a reconsideration should be 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 any of the following:
- Scientific data or research studies published in peer-reviewed medical journals
- Consensus of expert medical opinion (i.e., recognized authorities in the field)
- Medical opinion derived from consultations with medical associations or other health care experts
Acceptance by individual health care providers, or even a limited group of health care providers, normally does not indicate general acceptance by the medical community. Abstracts of papers, presentations at scientific meetings, testimonials indicating 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 shall be considered and its quality shall support the recommendation for reconsideration.
Adequacy of Evidence
The reconsideration should document that the scientific evidence is adequate to draw conclusions about the effectiveness of the intervention in routine clinical use in the population of Medicare beneficiaries.
|I||Obtained from systematic review or meta-analyses. Failing this, at least two properly designed randomized controlled trials.|
|II-1||Obtained from well-designed controlled trials without randomization|
|II-2||Obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group|
|II-3||Obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments could also be regarded as this type of evidence.|
|III||Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees|
|IV||Evidence insufficient to determine role|
|V||Evidence indicates potential for harm|
Size of Health Effect
Evidence from well-designed studies (meeting criterion #1 above) shall establish how the effectiveness of the new intervention compares to the effectiveness of established services and medical items.
Although not required, a preface to the accompanying literature could list the key elements of each article in the following format:
- Question Addressed
- Type of Study*
- Outcomes Studied
- Patient Characteristics
- Adequacy: Bias
- Adequacy: External Validity
- Size of Health Effect
* Type of Study
A = double blinded controlled trial (placebo, active or crossover), statistically significant
B = statistically significant but not double blinded or controlled
C = not statistically significant but likely to be so when enough data present-trend is present
D = single case report
Within 30 days of the day the request is received, Noridian must determine whether the request is valid or invalid. If the request is invalid, Noridian shall respond, in writing, to the requestor explaining why the request was invalid. If the request is valid, within 90 days of the day the request was received, Noridian will make a final LCD decision on the valid request and notify the requestor of the decision with its rationale. Decision options include retiring the policy, no revision, revision to a more restrictive policy or revision to a less restrictive policy.
If the decision is to revise the LCD the normal process for LCD development shall be followed. If the revised policy restricts an LCD, the process for comment and notice will be followed. The LCD does not require a comment and notice period in the following situations:
- Revised LCD that liberalizes existing LCD
- Revised LCD being issued for compelling reasons
- Non-substantive correction
- Revised LCD that makes a clarification
- Non-discretionary coverage/payment/coding updates
- Discretionary coding updates that do not restrict the LCD
Last Updated Jun 15, 2018