CMS Pub. 100-08, ch. 13, § 13.1.1

for LCDs

(Rev. 863; Issued: 02-12-19; Effective: 10-03-18; Implementation: 01-08-19)

An LCD, as defined in §1869(f)(2)(B) of the Social Security Act (SSA), is a determination by

a Medicare Administrative Contractor (MAC) respecting whether or not a particular item or

service is covered on a contractor–wide basis in accordance with section 1862(a)(1)(A) of

the Act.

1869(f)(2)(A) of the SSA outlines the process for Administrative Law Judge (ALJ) and

Department of Appeals Board (DAB) review of LCDs. This process is known as the LCD

Challenge Process. Procedures related to this challenge process are described in 42 Code of

Federal Regulation (CFR) part426.

§1862(l)(5)(B) of the SSA requires the MACs providing services within the same jurisdiction to

consult on all new local coverage determinations within the jurisdiction.

The 2016 21st Century Cures Act included changes to the LCD process, adding language to

1862(l)(5)(D) of the SSA to describe the LCD process. Section 1862(l)(5)(D), of the SSA

requires each MAC that develops an LCD to make available on the Internet website of such

contractor and on the Medicare Internet website, at least 45 days before the effective date of

such determination, the following information:

(i) Such determination in its entirety.

(ii) Where and when the proposed determination was first made public.

(iii) Hyperlinks to the proposed determination and a response to comments submitted to

the contractor with respect to such proposed determination.

(iv) A summary of evidence that was considered by the contractor during the development

of such determination and a list of the sources of such evidence.

(v) An explanation of the rationale that supports such determination.