On August 3, 2020, CMS released its CY2021 PFS proposed rule. CMS takes comment for 60 days (until October 5), and will aim to produce the final rule by about November 1, to stay 60 days ahead of the rule's implementation on January 1, 2021.
Links:
See the "inspection copy" or typescript publication, here.It weighs in at 1355 pages.- Regular publication in Fed Reg on August 17.
- See 85 Fed Reg 50074, 592pp, August 17, 2020, here.
- It's a remarkable 49 MB and not editable.
- I've made a cloud copy which is 25MB and is editable (comments, highlights).
- Here.
- It's rule number CMS 1734 P. Comment here.
- See the PFS fact sheet, here.
- See a special press release about telehealth here.
- See Foley Lardner summary of rulemaking in telehealth here.
- > Foley Lardner promises a forthcoming update re CMS's proposals to permanently extended telehealth (see also CMS press release just cited).
- See MedCityNews article, "Congress holds keys to telehealth expansion," here.
- > See House Bill HR 7663, Thompson (D-CA) here, which expands telehealth both "during emergencies or for other purposes." [FN1]
- See MedCityNews on Trump's Monday Executive Order on telehealth expansion, here.
- The actual E.O. here.
- See a special fact sheet about changes to the Diabetes Prevention Program rules here.
Quality Reporting
There's also a special fact sheet about changes to PFS physician quality reporting programs - here. However, if you read it, wait at least two hours before driving or operating heavy machinery.
Elderly Lab NCDs Die
For lab afficionados, the rule deletes two obsolete NCDs (one for cytogenetics and one for historical HLA testing) and updates some rules and timepoints around PAMA data collection, but the latter are direct effects of spring legislation. The next PAMA data cycle will collect data in 1Q2022, but it will be data from 1H2019, for a new 3 year PAMA cycle starting in 1/2023. Don't toss your 2019 billing records out by mistake; you'll need them in 2022.
Discussion of Digital Physiologic Remote Monitoring
At 85FR50117 forward, see a detailed discussion of the Medicare viewpoints on definitions and use of AMA CPT remote monitoring codes 99453,99454, 99457, 99091. "Commenters asked us, for example, to identify who can furnish RPM services, what kinds of medical devices can be used to collect data, how data should be collected, and how ‘‘interactive communication’’ is defined."
There's sometimes debate about whether only the CPT codes themselves, the actual code text, are relevant to CMS decisions or whether the various AMA CPT preambles and definitions and remarks are binding. In this discussion of RPM codes (85FR50117ff), CMS relies heavily on the details and the specific word choices used in AMA definitions and preambles. Cloud copy of these 5pp here.
RVUs and DHealth - iRhythm
For those who track the RVU system, there's a discussion of how to RVU-price the Irhythm ZIO patch technology (inspection copy version, p. 274-79). Shares popped 30% from $129 to $170 in morning trading. RVUs are designed to price physician services (e.g. surgeries) with specific assumptions around capital equipment, supplies, and time, and these are challenging for CMS with proprietary companies and internal operational costs. In addition, RVU assumptions are that CMS can find "costs" and price to the level of "costs." In the case of ZIO (as in pharma or as in the rest of the medtech industry), raw costs (COGS) are about 25% of revenue. The CMS rulemaking is also the first open public chance to see the AMA CPT reconfiguration of monitoring codes, which were passed last September 2019 but won't be openly published by AMA til around September 1, 2020.
See my blog on iRhythm's discussion in the rule, here.
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FN1
HR 7663 was introduced July 16 (press), but does not have legislative text posted yet as of 8/6/2020 at Congress.gov.. However, a PDF copy is online at the Thompson website here.
