What's up? I noticed some MACs conduct lab test gapfill with articles, websites, and data collection periods (due dates). But the MOLDX system is completely silent. In fact, they prefer to reach out privately to gapfill stakeholders by email (and in fairness, the great majority of gapfill tests are PLA tests with 1 source). My research finds that CMS is entirely silent - it requires MACs to use information to make gapfill prices by April 1, but CMS is silent on how to do it. Note, though, that when the gapfill proposals are published in summer, that does trigger a full blown capital P capital C public comment period, just as there is for LCDs, NCDs, and so on.
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2016 CMS 0623 PAMA Final Rule
page 49 / 81 FR 41083
New ADLT not CDLT (cw gf)
1834A(c)
This echoes what is already found at 1833(h)(8)
Develop procedures on or after 2005
71 FR 69701-704 CY 2007 rule (late 2006) 12 1 2006 2006 CMS 1201 PFS Final Rule 69701 Gapfill Regulation 414_508 (PDF 79).pdf
Also refers to 71 FR 66275-6, re 414.508, re CY2008 rule. (Nov 2007)
(Think second rule only added an appeal process)
Sources of information are listed, but not methods of obtaining it.
81 FR 41085 ( 6 23 2016)
Gapfilling info uses the four sources. Secretary may add additional information sources.
Secretary would do so by rulemaking. (It does not say that "MACs may use additional sources")
41086
Comment that labsa be requried to submit lab methods
CMS says MACs can consider lab methods as-is
The above refers to "current manual instructions"
They are not in Claims 16 = Labs.
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