Here's a small Medicare policy mystery. I've always said that NCD's are effective on the date published, and I recalled that was written right in the Medicare statute.
However, I can't currently find it in the Medicare statute, even though there are CMS documents from 2013 that state, the NCD effective date rule IS based on the Medicare statute.
### 01 Policy Page
Medicare has a policy page for the NCD process, including six downloadable documents.
https://www.cms.gov/medicare/coverage/determination-process
### 02 Fed Reg 2003
One of the older documents is 68 Fed Reg 55634, which was (back on September 26, 2003) a revised processed for NCDs. This document distinguished a national determination memo, from the "actual" NCD, which could appear several months later, and would include implementation instructions, such as the effective date. That is, the 2003 document detaches the implementation date from the NCD review process.
https://www.cms.gov/medicare/coverage/determinationprocess/downloads/fr09262003.pdf
### 03 MMA
A couple months later, along comes the Medicare Modernization Act (which introduced Medicare Part D) in December 2003, Public Law 108-173. Section 731 is "improvements in national and local coverage determination process." This introduced timelines, such as a 30-day public comment period and a final NCD not later than 60 days after the 30 day comment period. It also gives CMS authority to make temporary or permanent codes for NCDs.
### 04 Ten year gap: Fed Reg 2013
With a curious ten-year gap following (1) the NCD process (September 2003), and (2) the MMA (December 2003), CMS issued a revised NCD process on August 7, 2013. This one begins by acknowledging updates required by the MMA ...of 2003. 78 Fed Reg 48164.
https://www.cms.gov/medicare/coverage/determinationprocess/downloads/fr08072013.pdf
At page 48169, this publication states that the effective date of the NCD is the date of publication. However, it specifically refers this to SSA 1862(l) [1862 el] which has no explicit remark about the effective date of an NCD.
With publication of the final decision memorandum, the NCD is effective for claims with dates of service beginning with the effective date of the NCD. The memorandum contains, among other materials, the analysis and conclusions and also the NCD that becomes a part of the Medicare National Coverage Determination Manual (Pub. 100–3) of the CMS Internet Only Manual. After enactment of section 1862(l) of the Act [MMA], the effective date for the NCD is the same date as the publication date of the final decision memorandum. Therefore, we have found it expedient and practical to include the NCD that is [eventually] included in the Medicare National Coverage Determination manual in the final decision memoranda and to use that date as the effective date for Medicare coverage and payment purposes.
The text above, regarding NCD dates, is crystal clear except for one thing. There's no explicit remark about the coverage date at 1862(l). Maybe it can be legally inferred from the requirement, at 1862(l), that the NCD be completed no more than 60 days after the 30 day comment period.
### 05 Other Sources Ruled Out
To my knowledge, neither 21st Century Cures Act of 2016 (which altered LCDs) nor the Protecting Access to Medicare Act of 2014 (PAMA pricing), tinkered with NCD rules at SSA 1862.
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Here's Chat GPT's reading of my blog converted to an illustration.
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Typically, nowadays, an NCD might be issued on July 1, and CMS issues instructions to implement it on October 1. The October 1 instructions will say the NCD coverage has an effective date of July 1, and an implementation date of December 1. That means MACs have to be able to correctly process claims, with computer updates, not on July 1, not on October 1, but by December 1.
See CR 10878, issued April 10, 2019, in regard to an NCD issued on March 16, 2018, 13 months earlier. The implementation date is April 9, 2019, which was 120 days after a different transmittal issued November 30, 2019, about six months after the March 2018 NCD publication. Ouch.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R215NCD.pdf
In this unusual CR, CMS notes that stakeholders have complaints about the intrepretation of the NCD which CMS staff promise to address in the future with their MACs.
