However, CMS struck some unusual positions in the rulemaking.
The rule hinges on "molecular tests" (which CMS does not define very clearly in the first place), while excluding "PLA code tests and genomic procedures." Since CMS has already been classifying genomic PLA code tests and GSPs as "molecular tests" that are billable by the hospital, "Status A," and CMS has introduced no new modifiers or status indicators for implementing the new 14 day rule revision, the exclusion by of some Status A tests by"text" and the inclusion of the same tests by "status indicator A" in tables is confusing.
In addition, CMS had proposed in the original rulemaking that it would include ADLTs of the MAAA type (Type 1) but exclude ADLTs of the FDA approved type (Type 2). You would only have noticed this if you had read the proposed rule citations and cross-references to regulations by number extremely carefully. The world is still waiting for CMS to create ADLT application forms, but some tests would qualify for both Type 1 and Type 2 ADLTs, or shift from Type 1 to Type 2 based on a new FDA approval, and since all ADLTs are sole source and not performed by the hospital, the rationale is unclear. Also, why classify ADLTs as in or out based on FDA approval when other molecular tests are "in" (such as EGFR or BRAF tests) regardless of FDA approval.
To my understanding, CMS's internal definitions of "molecular pathology tests" relative to the 14 day rule have mostly been intuited by reading what tests they do and do not classify as "Status A" for hospital billing purposes on a rolling basis.[*] Those billing status classifications - including for 2018 - simply don't match the verbal text of the final rule. Also, it makes no sense to exclude PLA tests that are genetic tests, or genomic sequencing procedures that are generally less expensive than code stacking the relevant single genes. These comments about excluding PLA and GSP codes appear only in the final rulemaking so the world didn't have a chance to tap CMS on the shoulder until now.
CMS formally only takes comment on "new" things appearing in the final rule. CMS proposed no regulation in the July rulemaking, so the whole regulatory text for 14 day rule is "new." Also, it appears CMS has made clear errors in the verbal text relative to the intended concepts. All CMS remarks about PLA and GSP tests are "new." The public can make comment to CMS now.
I've made a ZIP file that contains all the documents that might be relevant to a comment. This includes
- The original July rule proposal;
- The final November version;
- Addendum B, which classifies all CPT codes by outpatient billing status;
- Addendum D, which explains the cryptic status indicators;
- Current text of 42 CFR 414.510, including the new section created by rulemaking this month.
In Addendum B, I've tried to collate all the U codes, M codes, and molecular CPT codes on one sheet, since they are scattered in different places in the CMS spreadsheet. I might have missed something, so the entire 16,000 line original table is also there.
The Formal Comment Page is here.
The ZIP FILE is here.
[*] I flagged this obscure phenomenon for readers back in May, 2017, here. (I also noted then that some of the "A" classifications appear wrong by CMS's own protocols. For example it generally excluded genetic sequencing of pathogens but erratically included one or two.)