On December 2, 2020, CMS released the final Outpatient Rule for CY2021. (Typically, these annual rules are released on November 1 to allow 60 days' implementation).
- See the Fact Sheet here.
- See the typescript inspection copy rule here.
- It weighs in at 1312 pages.
- The final rule will appear typeset in the Federal Register in a week or so.
- Look for it here on Dec 29.
- See trade press at Healthcare Dive here.
One of the big topics is cuts to the 340B program, which alters drug prices in certain hospital settings. Another is cutbacks (and proposed termination) of an "inpatient only" list that has existed for years. Hospital associations generally opposed losing the list. The list means that certain procedures are automatically covered at inpatient rates, and Medicare can't second-guess if they might have been done as outpatient procedures as a cheaper alternative.
Date of Service Lab Test Policy - Revised
CMS has defined the "date of service" of lab tests as the "date of specimen collection" since about 2008. later, it bundled most hospital outpatient lab tests to visit fees (e.g. E.R. or outpatient clinic visit fees) in about 2014. Genetic tests have always been excepted from this bundling rule, they are paid separately.
CMS proposed to add protein-based MAAA tests as separately billable under the hospital DOS rule. Beyond that change, the rulemaking made be of interest for its elaborate historical review of the twists and turns of DOS rule changes. In the typescript or inspection copy version, see pages 1135ff, with 1135-1145(!) being historical review.
Rationale Actually Applies to Nearly All Lab Tests
CMS says it will adopt, as proposed, the exception from DOS bundling to DOS independent payment, for protein MAAA tests. CMS writes, "These tests have a pattern of clinical use that make them relatively unconnected to the primary hospital outpatient service during which the specimen was collected and the results of these tests are typically used to determine post-hospital care and generally reduces delay with respect to access to these tests and subsequent results." Actually, a vast number of lab tests would not be used to determine care during a hospital outpatient clinic visit, unless they are stat lab tests or point of care tests. But let's not quibble.
CMS Discriminates Against Cancer Protein MAAA Tests if "PLA Coded"?
Although the text is circuitous, CMS seems to want to provide cancer-protein-MAAA test status only to 80,000 series MAAA tests, and not to MAAA tests under PLA codes. It seems CMS does not want to filture through 200-plus PLA codes for eligible tests, numbered sequentially and with no pattern, but is willing to look to one page of CPT that is explicitly titled "MAAA" tests where codes are grouped together as "MAAA" codes (815xx). CMS writes, "In contrast to non-PLA codes, categories into [groups], PLA codes are not separated in separate categories. like Category I CPT codes."
This is concerning, because AMA has signaled that tests may begin as PLA codes and be "elevated" to CPT Category I status by text marker next to the PLA code.
Specific PLA coded tests that were denied status included Cernostics 0108U, EPI by BioTechne 0005U, and KidneyIntelX 105U. CMS noted the codes were "new, and with none to minimal utilization."
CMS Squeezes Crescendo Test in with Cancer Tests
CMS seems to be willing to consider changes and adaptations on a rolling basis, as it elevated the Crescendo rheumatoid arthritis test 81490 to unbundled status even though it is not a cancer MAAA test, the original policy paradigm. Code 81490 for Crescendo is simply written into the regulation by itself:
Metabolite Tests Discussed, Not Included Yet
Arguments to include "protein and metabolite" cancer MAAA tests, as well as "protein cancer MAAA tests," were acknowledged but not adopted.
Another Tidbit from the OPPS rule
There's a regulatory insertion regarding pandemic, infection prevention, and antibiotic stewardship, at 42 CFR 485.640, and 482.42, regarding conditions of participation. CMS is treating reporting of COVID patients and drug supplies as a condition of participation. Page 1305, 1306 of the rule.