Thursday, May 14, 2020

Very Brief Blog: How Will Medicare Price the Two COVID Serology Codes?


I'm leaving the original blog from May 14 intact, but on May 19, CMS released pricing for the single-strip and the liquid phase COVID SEROLOGY tests (86328, 86769).  The are priced at $45.23 and $42.13 respectively.


My most-frequently-asked question in the past week or two has been, How will CMS price the codes for COVID-19 serology?   This has a lot of implications for the lab industry, because the services will potentially be used millions of times.

Necessary Background

Let's work up to that question with some background.   On February 13, 2020, CMS created two codes for COVID-19 virus detection, e.g. PCR.   These were codes U0001 and U0002, for  CDC kits and commercial kits, respectively.  (I believe CMS assumed the CDC kits were free, leading to a lower CMS price for U0001 to labs).   Within a couple weeks, CMS announced that their MACs had collectively issued uniform "local" prices (at about $35 and $50, respectively).    That is, the pricing was a "MAC" local decision (where all MACs happened to match each other), not a "federal" decision.   On April 15, CMS created two new COVID detection codes, for "high throughput" detection, defined as >200 cases per platform.   CMS created codes U0003/U0004 by an "Administrator's Ruling," a rare type of action, and concurrently priced codes U0003/U0004 federally at exactly $100 each.   Details here.

Creation of Serology Codes; CMS Silent on Pricing

Meanwhile, on April 10, AMA CPT created two codes for COVID serology (antibodies).  
  • 86328 describes a reagent strip or similar method, 
  • 86769 describes a more complex method (e.g. the Electrosys Roche test).  
  • AMA info here, here.  
These are AMA codes; AMA does not set prices.   CMS has been silent on how these codes are priced.  While AMA created the codes on April 10 and "effective April 10," but I'm not sure if CMS has made these codes active in CMS claims processing computers yet.   CMS set its software to accept codes May 1; see CMS PDF online here.

I haven't seen any CMS news on how they are priced.  CMS could have issued pricing for these serology codes in interim federal rulemaking on April 30; CMS was silent on pricing then, although they did issue a ruling that the serology codes were covered by Medicare.  (Here.)  (See footnote). 

What We Know:  86328/86769 Set for CMS's Summer/Fall Lab Test Pricing Process

Here's what we do know.   

For all new lab codes (except for U0003/U0004, set by direct federal decision-making, see above), CMS by law holds summertime public meetings and issues final prices in late fall.   

That's the process that 86328/86769 are currently tracked into, although nothing prevents CMS from issuing provisional MAC prices as they did for U0001/U0002 in April.

See the codes on the June 2020 meeting agenda here:

click to enlarge, agenda items 95/96

I discussed the normal CMS pricing process in a prior blog here.  
  • If no higher decision intervenes, the codes will be MAC-priced locally all year.   
  • CMS will take public comment on correct pricing for 86328/86769 on June 22 in a virtual public meeting, then...
  • Hold a professional advisory panel on July 29/30 to discuss correct pricing.  
  • Taking this input, CMS will issue proposed pricing in early September
  • Take public comment for 30 days, and 
  • Issue final pricing for 86328/86769 in November, which will be...
  • Nationally effective on the clin lab fee schedule on 1/1/2021.     
Other events, in no preferred order, include:
  • CMS asks MACs to decide on local prices, and CMS makes them public, as it did for U0001/U0002.  CMS doesn't have to do this.
  • CMS issues pricing in the next Interim Final Rulemaking, assuming there is one.
  • Congress sets CMS serology pricing in the next COVID bill, assuming there is one.
  • CMS issues pricing for serology codes by Administrator's Ruling (unlikely; A.R.'s are very rare).
Absent one of these events, the CLFS pricing process will creep along til November.   The lab industry may advocate for quicker and more public pricing news before that. 

Update: In a 5/15/2020 PDF, CMS notes that the serology tests are currently locally priced until a CMS national price is announced - here.

AMA/CPT Antigen Testing

There is no code yet for COVID antigen testing; either AMA CPT or CMS could create such a code through the urgent channels used for the other COVID codes.

Historically, CMS has been pretty frugal when pricing infectious disease assays (current prices reflect PAMA survey prices, not the prices originally set administratively by CMS).  For example, 87880 is immunoassay, visual observation of result (like a strep throat laminar flow assay), $16.53.  Tests for both HIV antigen and HIV antibodies are circa $33 (87804).  CMS showed it was willing to go to more robust pricing for U0003/U0004 due to the COVID emergency.   


Note regarding scope of this article. 

I should point out I'm only considering the Medicare price.  

An expert pointed out that commercial insurance, per the CARES Act, H.R. 748, Section 3202, must cover COVID testing without copay and at one of two prices.  Either the negotiated (contracted) rate with the lab, or else, the lab's public cash price on the lab's website which it shall post.   


In April 30 rulemaking published May 8 (here, 85 Fed Reg 27550), p. 27598, CMS announced that serology tests were covered, noting it normally makes coverage decisions through NCDs, but here, through emergency rulemaking.  

CMS sort of danced around the medical usefulness of serology testing with the following text:

Having COVID–19 serology test
results is useful to individual patients,
their practitioners, and their
communities because it could change
the decisions Medicare beneficiaries
make for themselves and influences
practitioner management of the
beneficiaries’ medical treatment.

If it can be determined that they are
immune, these patients would possibly
not be at risk for contracting COVID–19
and not be risking the health of their
communities if they travel outside of
their home as they would not spread

Among the biggest risks to
the community are patients with
COVID–19 infection who have not
developed symptoms or had minor 
nonspecific symptoms, yet are infectious.51

Beneficiaries who are negative for
COVID–19 antibodies through serology
testing may need to take more
preventive measures to reduce their
personal risk of infection as some
persons, based on age and other factors,
are at higher risk of serious illness or
death from the disease. Further, a
practitioner should discuss the results
of the serology test with the beneficiary
to ensure that the beneficiary
understands the results of the test and 
the results are considered in the overall
management of the patient.  

CMS then writes:

We would not expect
such tests to be performed and billed
unless clinically indicated.

We are finalizing on an interim basis,
that during the PHE for the COVID–19
pandemic, Medicare will cover FDA
authorized COVID–19 serology tests as
they are reasonable and necessary under
section 1862(a)(1)(A) of the Act for
beneficiaries with known current or
known prior COVID–19 infection or
suspected current or suspected past
COVID–19 infection.

This is a really broad coverage conclusion:  serology tests are "reasonable and necessary" if the patient has "known current or prior infection" or "suspected current or past infection."   This is a much broader use of the term "reasonable and necessary" than CMS and MACs usually employ, but it's now written into federal law at 42 CFR 410.32.   For example, the MolDx MACs had (have) a 2019 policy against viral panel testing for reasons that help the community or help patients make decisions; panels had to be useful for medically managing the individual patient's disease (e.g. LCD L37348).  CMS also describes the serology test as assisting in "preventive" methods (above) but MACs are usually loathe to consider "preventive" features of testing as grounds for Medicare coverage.  

The exact language at 42/410.32 is:

^ FDA-authorized COVID–19 serology
tests are included as covered tests
during the Public Health Emergency, as
defined in § 400.20 of this chapter, for
the COVID–19 pandemic, as they are
reasonable and necessary under section
1862(a)(1)(A) of the Act for beneficiaries
with known current or known prior
COVID–19 infection or suspected
current or suspected prior COVID–19