If you'd like one more original document, not further discussed, the FDA's March 31 8-page guidance on COVID LDT testing - here.
CARES ACT
https://www.congress.gov/bill/116th-congress/house-bill/748/text
Congress.gov provided a locked version of the bill you can't highlight. I've put an unlocked version in the cloud here.
See sections on PAMA delays at S. 3718. PAMA round 1, year 3, is proceeding as normal, as always expected, with 10% payment cuts on those tests that had a greater than 20% payment drop from PAMA 1 data (2017/2018).
Next year, in 2021, there will be a fixed fee schedule (same as 2020) with 0% cuts.
In 2022, there will be reporting of PAMA, reporting 1H2019 claims. In 2022, there will be 15% fee cuts on any tests that still have such a steep cut remaining based on 2017/2018 data, that is, PAMA round 1.
In 2023-2024-2025, there will be a new Round 2 PAMA three year fee schedule. In its first two years, 2023, 2024, cuts of up to 15% are allowed. Unlimited cuts in 2025 and forward. I've tried to capture this with the following chart (click to enlarge):
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But wait, there's more, about commercial insurance and COVID.
In the next section, I'm summarizing in general terms, for the exact terms see the law itself.
Sections 3201, 3202, 3203 cover private insurance and COVID testing.
- 3201 defines a COVID 19 as one cleared or authorized by the FDA (including emergency use) or one for which the LDT intends to apply for emergency use.
- Section 3202 says that for group health plans or health insurance, the health plan will reimburse the lab a pre-existing negotiated rate OR ELSE, the cash pay rate the lab has on public internet. Section (b) requires the lab to post a cash price on the internet.
- Section 3203 is interesting and deems COVID preventive services and vaccines to be covered services, at such future data as vaccines are invented.
CMS INTERIM FINAL RULEMAKING re COVID EMERGENCY
CMS announced in rule CMS 1744 IFC that it was making multiple interim changes in federal rules to help deal rapidly and efficiently with the COVID crisis. Interim final rulemaking means that comments are accepted, but, the rule itself is effective quickly, before the normal run of a comment and revision period.
CMS has an infographic (March 30) of emergency waivers and rules, here.
See the full press release and summary from CMS here. For example, CMS has emergency "hospitals without walls" rules to cover tent-setups, use of empty college dorms, etc.
See article about the changes from Hayes and Boone law firm, online here.
There's a lot of rulemaking here in the Interim Final Rules, including for example a range of Stark emergency COVID waivers analyzes on the Faegre Drinker website here. Basically, CMS marches in 63 pages through a whole host of CMS rules and regulations. Diabetes Prevention Services could only be given in brick and mortar classes; now they can be telehealth. DME NCDs and LCDs required face to face encounters; now they don't. Opioid Treatment Programs could have audiovisual counseling sessions; now they can be telephonic only; etc.
CMS creates (with several pages of discussion) codes G2023 for COVID specimen collection and G02024 for SNF/Home Health COVID collection, priced at $23 and $25. (Normal collection fees are more like $3). 85 Fed Reg 19257-8.
You can comment on the Interim Final Rules, which were issued and effective March 31, until June 1, 2020.
CMS INFORMATIONAL ALERT - MEDICAID, TELEHEALTH
CMS also has a multi-section press release webpage and summary dated April 3, 2020 here. See, for example, a 23 page letter on rural Medicaid, CHIP, and telehealth policy updates here. See also a 19 page Medicaid FAQ here.
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CMS's own summary of topics in the Interim Final Rule is as follows. The CLFS section is about the coding and pricing for COVID specimen collections.
[This rule covers:]
...issues related to telehealth services, and
communication technology-based
services; frequency limits on subsequent
care services in inpatient and non-
facility settings, critical care
consultations, required ‘‘hands-on’’
visits for ESRD monthly capitation
payments; removal of restrictions on
technology, and supervision of
interactive telecommunications
technology; clinical laboratory fee
schedule; services furnished by opioid
treatment programs; payment under
Medicare Part B for teaching physician
services and resident moonlighting;
remote physiologic monitoring;
physician supervision flexibility for
outpatient hospital services; payment
for office/outpatient evaluation and
management visits; counting of resident
time at alternate locations; Ambulance
Fee Schedule; rural health clinic
services; federally qualified health
center services; and inpatient hospital
services furnished under arrangements
outside of the hospital.
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