Local coverage determination (LCD) development process

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Home ► Coverage resources ► Local coverage determination (LCD) development process

Last Modified: 1/1/2024 Location: FL, PR, USVI Business: Part A, Part B

The local coverage determination (LCD) development process

A Local Coverage Determination (LCD) is a determination as to whether a particular item or service is considered to be reasonable and necessary in accordance with Section 1862(a)(1)(A) of the Social Security Act (SSA). LCDs must be consistent with all statutes, rulings, regulations, and national coverage, payment and coding policies.

Review our LCD development process flowchart pdf file

Detailed instructions regarding the LCD development process are found in the Medicare Program Integrity Manual (PIM), CMS Publication IOM 100-08, Chapter 13. The process includes consultations with experts (local medical societies and medical consultants), publication of the proposed policy, opportunity for public comments in writing, publication of a final LCD with a related response to comments article, and notice of the new policy.

First Coast publishes LCDs on the CMS Medicare Coverage Database (MCD) external link

, to provide guidance to the public and medical community within our geographic jurisdictions. A list of the LCDs with links to the policies may be found at Active LCDs and Articles.

LCDs may be developed and/or revised in response to internal requests as well as external requests sent to medicalaffairs@guidewellsource.com , or by fax to 1 (717) 526-6389. The topics submitted with the various requests will be added to the First Coast -waitlist and will undergo an internal prioritization process which includes review of literature submitted. This process can take up to 12 months or more to complete. Topics are prioritized based on claims data, including how often a service is billed and the frequency a service is being denied. Access to care as well as associated health outcomes are also considered. Depending on the issue and/or procedure involved, a policy may or may not be developed.

Coverage requirements

LCDs may allow coverage of a service or item if it meets all of the following conditions:

• A benefit category exists for the service in Title XVIII of the SSA. Under the Medicare program, the scope of benefits available to eligible beneficiaries is prescribed by law and divided into several main parts. Part A is the hospital insurance program and Part B is the voluntary supplementary medical insurance program. Medicare rules, regulations, and guidance documents, including the IOM 100-02, The Medicare Benefit Policy Manual, further describe the benefits available.

• The service is not excluded by other sections of Title XVIII of the SSA. Such exclusions generally include, but are not limited to: routine physical exams, cosmetic surgery, hearing aids, eyeglasses, and most dental care.

• The service is not already covered as a specified Medicare benefit, as an exception to the requirement for the service to be reasonable and necessary, e.g., pneumococcal, influenza, and hepatitis B vaccines.

• The service is considered reasonable and necessary under Section 1862 (a)(1)(A) of the SSA. To be considered reasonable and necessary, the service must be:

• Safe and effective;

• Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, which meet the requirements of the Clinical Trials NCD)

• Appropriate, including the duration and frequency that is considered appropriate for the item or service in terms of whether it is:

• Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member;

• Furnished in a setting appropriate to the patient’s medical needs and condition;

• Ordered and furnished by qualified personnel;

• One that meets, but does not exceed, the patient’s medical need; and

• At least as beneficial as an existing and available medically appropriate alternative

Supporting evidence

When developing LCDs First Coast will use publicly available evidence of general acceptance by the medical community including but not limited to: published original research in peer-reviewed medical journals, randomized clinical trials, systematic reviews, and meta-analyses, evidence-based consensus statements and clinical guidelines. Refer to our guidance on the strength of medical literature/evidence pdf file

that may be used in the development of LCDs.

Comment period

First Coast provides a 45-day comment period for each proposed LCD. This comment period is scheduled to include time before and after the open meeting. The proposed LCDs, the proposed status, and information about how to submit a comment are listed at Proposed LCDs and Articles.

Contractor advisory committee (CAC)

The CAC provides a formal mechanism for members to be informed of the evidence used in developing an LCD and promotes communications between the Medicare Administrative Contractor (MAC) and the healthcare community. CAC members will serve in an advisory capacity as representatives of their constituency to review the quality of the evidence used in the development of an LCD. The final decision on all issues rests with the contractor medical directors (CMDs).

The CAC is used to supplement the MAC’s internal expertise and to ensure an unbiased and contemporary consideration of “state of the art” technology and science.

Meetings are not held to discuss an already written proposed (draft) LCD. Information about the location, date, topic, time of the meeting, and how to register is located on our CAC meeting page.

Open meeting

An open meeting will be held after the proposed LCD is published for comment. The intent of the open meeting is to discuss the review of the evidence and the rationale for the proposed LCD(s) and to provide an opportunity for interested parties to make presentations of information related to the proposed LCDs. Information about the location, date, proposed LCD, time of the meeting, and how to register is located on our Open meeting page.

Posting of final LCDs and notice period

After consideration of all comments received, and any necessary revision of the proposed LCD(s), the final LCD(s) are posted on the First Coast website and the MCD for a notice period of 45 days. A response to all comments in the form of a Response to Comments Article will be posted at the same time as the final LCD on the MCD external link

with links to the policies, billing and coding articles, and Response to Comments Articles at Active LCDs and Articles.

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