Overview
The Local Coverage Decision (LCD) Reconsideration Process is a method by which interested parties can request a revision to an LCD. The whole LCD or any part of the LCD should be reconsidered and the process is available only for final LCDs.
Valid LCD Reconsideration Request Requirements
1. LCD reconsideration requests will be considered from the following:
- Beneficiaries residing or receiving care in Ohio or West Virginia
- Providers doing business in Ohio and West Virginia
- Any interested party doing business in Ohio or West Virginia
2. Reconsideration requests can only be accepted for LCDs published in final form. Requests shall not be accepted for other documents including:
- National Coverage Decisions (NCD)
- Coverage provisions in interpretive manuals
- Draft LCDs
- Template LCDs, unless or until they are adopted
- Retired LCDs
- Individual claim determinations
- Bulletins, articles and training materials
- Any instance in which no LCD exists (e.g., requests for development of an LCD)
If modification of the LCD would conflict with an NCD, the request would not be valid. Information on how to make requests for NCD reconsiderations can be found at www.cms.hhs.gov/DeterminationProcess.
3. Requests shall be submitted in writing and shall identify the language that the requestor wants added to or deleted from an LCD. Requests shall include a justification supported by new published evidence, which should materially affect the LCD’s content or basis. Copies of published evidence shall be included. The evidence required to support the review is listed below.
Reconsideration Process
1. LCD Reconsideration Requests that meet the definition of a valid request as outlined above should be submitted to:
- Postal Address
Robert R. Kamps, M.D.
LCD Reconsideration Process
4249 Easton Way, Suite 400
Columbus, OH 43219
- E-mail Address
Robert.Kamps@PalmettoGBA.com
- Fax
(614) 473-6204
2. Within 30 days of the day the request is received, a determination will be made on whether the request is valid or invalid. If the request is invalid, the requestor will be notified in writing explaining why the request was invalid. If the request is valid, the reconsideration process will continue.
3. Within 90 days of the day the request is received, a final LCD reconsideration decision on the valid request will be made, and the requestor will be notified of the decision with its rationale. If the decision is to revise the LCD, the normal process for LCD development will be followed.
Evidence Required for the Review
Information for reconsideration should address both the source of the evidence and the content as discussed below.
Source of the evidence
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 the following:
- 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 one of the following:
- Scientific data or research studies published in peer-reviewed medical journals
- Consensus of expert medical opinion (e.g., 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.
Content of the Evidence: Two questions should be addressed to support the reconsideration. First, 'is the evidence concerning effectiveness in the Medicare population adequate to draw conclusions about magnitude of effectiveness relative to other items or services?' Second, 'how does the magnitude of effectiveness of the new medical item or service compare to other available interventions?'
1. 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.
| Type | Evidence |
| 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 |
2. 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.
For further discussion of these issues, view www.cms.hhs.gov/faca.
Annotated Literature Review
Although not required, a preface to the accompanying literature could list the key elements of each article in the following format:
Reference:
Question Addressed
Type of Study*
Outcomes Studied
Patient Characteristics
Test/Intervention
Results
Adequacy: Bias
Adequacy: External Validity
Size of Health Effect
Comments
* 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
Effective Date: 12/7/2003