1 AMA Creates COVID Code
2. CMS Prices its own COVID Codes $36, $53
3. AMP and COVID Payment Legislation
4. Congress Introduces VALID Act for Lab Reform
5. Sidebar: Economist article on COVID biology and virology
6. Sidebar: Trump's Remark re Obama Rules
1. AMA CREATES COVID CODE 86735
AMA rapidly drafted a new single code for COVID-19 testing and made it immediately available for us, if payers can load it that fast.
See the AMA CPT COVID webpage here. AMA also popped out a 4 page fact guide for the code, PDF here. For example AMA coding advice states that if separate samples for nasal and pharyx are run, and reported separately, bill 87635 on two lines with modifier 59 on the second line.
This is a standard CPT Category I code in the molecular microbiology section, at code 87635. The text is:
Infectious agent detection by nucleic acid (DNA or RNA);severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique
AMA does not set fee schedule prices.
2. CMS PRICES ITS COVID CODES 0001U, 0002U, $36, $53
On around March 6, CMS released two new CPT codes 0001U and 0002U for use by Medicare or other payers effective April 1 (but dates of service retroactive to February).
CMS did not set a national price but asked each MAC to set a price and tell CMS. MACs set prices of $36 for CDC Test Kit Based Test, and $53 for other tests. I believe the rationale is that CMS assumes labs running CDC Test Kit get it for free and only incur additional operating costs. See the CMS pricing PDF here. Or equivalently, CMS MACs think the cost of running the tests are $36 and the costs of COVID reagents is $17 ($53-36). I saw a notice today that California Medicaid (Medi-Cal) adopted the same pricing as Medicare.
CMS has a consolidated webpage for transcripts of its COVID calls here.
NERD NOTE: PAYABLE IN MEDICARE OUTPATIENT SETTING
In the vast, vast majority of cases*, CMS bundles hospital clinic outpatient microbiology tests (like clinical chemistry) to underlying ER or clinic visit fees. This is called Status Q4 for hospital outpatient billing. Human genetic tests are billed separate (called Status A). CMS classed U0001 and U0002 as Status A, meaning they are separately payable (unless patient is admitted).
3. AMP CONCERNED ABOUT LEGISLATIVE FLAW
Congress is in the midst of passing legislation mandating payment for COVID testing but AMP believes there is a technical flaw in the legislation. The concern hinges on the placement of wording about FDA emergency use approval (EUA), which some labs have and some labs don't (for example, it might be pending). Also, requirements for EUA may change rapidly.
See the AMP press release online here.
4. VALID ACT ON THE HILL
Lost in the pandemic news, on March 5, 2020, House and Senate introduced matching versions of the VALID ACT, which would heavily reform and change the entire FDA process around diagnostic lab tests (see open access article at 360DX here.)
Sen. Rand Paul introduced A DIFFERENT BILL (!!) on March 18, AMP press release here.
See lengthy, and I believe open access, article by Turna Ray at Genomeweb on March 16, here. She weaves together a deep dive on VALID with a deep dive on COVID.
Economist Open Access Article on Science of COVID
The ECONOMIST published a nice Scientific-American level article on COVID biology and virology - email registration - here.
President Trump's Remark about Obama Rule Delaying COVID Testing
A few days ago, there was a spat that involved President Trump remarking on March 4 than "an Obama rule" had delayed COVID testing. There were responses that this was not true (or stronger language). Molecular pathologist and policy expert Roger Klein MD PhD was featured in an article on the topic in the conservative paper Epoch Times March 12 (readable with email registration, here.)
Propublica wrote a detailed article on the FDA policy steps here.
? RNA Extraction Supplies
Around March 12, there were a flurry of stories that US would run out of RNA extraction kits, which are more difficult and constrained to manufacture than any particular set of viral test probes (see e.g. here). My MBA-school math was that you could bravely or even heroically ramp up RNA kit production 24/7 (e.g. 3-fold) but maybe demand was going up 100X or 1000X, a different order of magnitude. We haven't particularly heard more about this.
I've read that typical tests use 4 wells in a 96 well plate (about 24 patients per plate), and that some forms of test run in 3-4 hours. Running 1M tests at 24 per plate at 4 hours turnaround per set would be about 7000 days of 24/7 plate time (for one plate reader). If 1M tests took 2 minutes of tech time each (handling, records, etc) that would be 2,000,000 minutes of tech time or 33,000 hours of tech time or about 16 2000-hour work-years of tech time. To do the 1M tests and 2M minutes of labor in one month would require 208 160-hour work-months or 208 techs for a month.
* I discovered scattered molecular microbiology codes that are Status A payable, while nearly identical codes are always Status Q4 not payable separately. As far as I could tell, the rare erratic assignment of a few molecular microbiology codes as "A" amongst the long CPT code lists of molecular microbiology codes was simply erratic.