Take 5: Medicare News Flash – May 2021



No time to read all those wordy transmittals? Here’s news you can peruse in under 5 minutes.

Catch up on the latest Medicare Part A/B news communicated via Medicare Learning Network (MLN) articles on your break. Below are summaries of notable coding and billing changes.

FDA Retracts Bamlanivimab EUA

The COVID-19 Public Health Emergency (PHE) may be extended another 90 days from April 21, 2021, but the Food and Drug administration (FDA) has revoked the Emergency Use Authorization (EUA) for bamlanivimab, when administered alone, for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients.

Medicare will cover and pay for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, for dates of service from Nov. 10, 2020 – April 16, 2021, only.

The affected codes are M0239 Intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring and Q0239 Injection, bamlanivimab, 700 mg. These codes are discontinued effective July 1, 2021.

New CPT® Codes for Novavax

The American Medical Association (AMA) announced the creation of three new CPT® codes for a COVID-19 vaccine that is still pending FDA EUA approval.

Check the Centers for Medicare & Medicaid Services (CMS) website periodically for updates to payment allowances for COVID-19 vaccines and their administration during the PHE.

CodeShort DescriptorLabelerVaccineNational Payment AllowanceEffective Dates
91304SARSCOV2 VAC 5MCG/0.5ML IMNovavaxNovavax Covid-19 Vaccine$0.010xx/xx/xxxx – TBD
0041AADM SARSCOV2 5MCG/0.5ML 1STNovavaxNovavax Covid-19 Vaccine Administration – First Dose$40.000xx/xx/xxxx – TBD
0042AADM SARSCOV2 5MCG/0.5ML 2NDNovavaxNovavax Covid-19 Vaccine Administration – Second Dose$40.000xx/xx/xxxx – TBD

Order/Referral Now Needed for These Labs

Effective for claims processed on and after May 4, 2021, the ordering/referring provider’s National Provider Identifier (NPI) is required for CPT® codes 87632 Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 6-11 targets and 87633 Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets.

During the COVID-19 PHE, CMS temporarily removed the requirement that certain diagnostic tests be ordered by the treating physician.

A COVID-19 PHE waiver of these requirements is still in place for the following codes:

U0001 – U00048763586769
863288727587276
872798740087501 – 87503
876318780487280
874208763487807
Novitas Solutions

Medicare patients may continue to receive coverage for these COVID-19 related tests without the order of a physician or nonphysician practitioner (NPP), effective March 1, 2020.

Update Your List of Waived Tests

CPT® code 87636 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique is now a Clinical Laboratory Improvement Amendments (CLIA)-waived test, effective Oct. 6, 2020. This means the test poses a low risk for an incorrect result, according to the Centers for Disease Control and Prevention (CDC).

See MLN Matters® article MM12269 for details; and see article MM12204 for a list of other CLIA-waived tests, which require the QW modifier to be recognized as such.

CMS Updates Colorectal Screening Test NCD

Medicare will cover a blood-based biomarker test as an appropriate colorectal cancer screening test once every three (3) years, effective Jan. 19, 2021. The test must be performed in a Clinical Laboratory Improvement Act (CLIA)-certified lab and must be ordered by the treating physician.

See NCD 210.3 section 3.b for conditions of coverage. See also MLN Matters® MM12124 for a list of National Coverage Determinations (NCDs) that have been recently revised to reflect ICD-10-CM updates.

How to Report COVID-19 Vaccine Waste

“Waste not, want not,” the Centers for Disease Control and Prevention (CDC) says about the COVID-19 vaccine. But if it can’t be helped, they want to know about it. The CDC released updated guidance on May 18 to explain how providers should report drug waste/spoilage of COVID-19 vaccine vials.

To document COVID-19 vaccine waste, use the VTrckS ExIS Interface for Wastage. You will need the following information:

  • Provider PIN
  • National Drug Code
  • Number of doses wasted
  • Wasted reason

Note that as long as the vaccine is free, providers will not be compensated for reporting its waste. Reporting COVID-19 vaccine waste is required for inventory purposes only.

Wastage Reporting Table

CDC, 5/18/21

Tips to Reduce Vaccine Waste

The CDC expects providers to take measures to avoid COVID-19 vaccine doses from being wasted. “Remember, the federal government has advised COVID-19 vaccination providers that viable doses should never be wasted, even if it means vaccinating an individual outside the current groups prioritized for vaccination,” the CDC states.

Code Changes Effective July 1

The HCPCS Level II quarterly update for July is now available. There are 20 new codes, and five codes are being removed.

HCPCSACTIONLONG DESCRIPTION
A9593ADDGallium ga-68 psma-11, diagnostic, (ucsf), 1 millicurie
A9594ADDGallium ga-68 psma-11, diagnostic, (ucla), 1 millicurie
C1761ADDCatheter, transluminal intravascular lithotripsy, coronary
C9075ADDInjection, casimersen, 10 mg
C9076ADDLisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose
C9077ADDInjection, cabotegravir and rilpivirine, 2mg/3mg
C9078ADDInjection, trilaciclib, 1 mg
C9079ADDInjection, evinacumab-dgnb, 5 mg
C9080ADDInjection, melphalan flufenamide hydrochloride, 1 mg
C9778ADDColpopexy, vaginal; minimally invasive extra-peritoneal approach (sacrospinous)
G0327ADDColorectal cancer screening; blood-based biomarker
J0224ADDInjection, lumasiran, 0.5 mg
J1951ADDInjection, leuprolide acetate for depot suspension (fensolvi), 0.25 mg
J7168ADDProthrombin complex concentrate (human), kcentra, per i.u. of factor ix activity
J9314ADDInjection, romidepsin, non-lyophilized (e.g. liquid), 0.1 mg
J9348ADDInjection, naxitamab-gqgk, 1 mg
J9353ADDInjection, margetuximab-cmkb, 5 mg
M0244ADDIntravenous infusion, casirivimab and imdevimab includes infusion and post administration monitoring the home or residence; this includes a beneficiary’s home that has been made provider based to the hospital during the covid 19 public health emergency
M0246ADDIntravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring in the home or residence; this includes a beneficiary’s home that has been made provider based to the hospital during the covid 19 public health emergency
Q5123ADDInjection, rituximab-arrx, biosimilar, (riabni), 10 mg
C9065DiscontinueInjection, romidepsin, non-lyophilized (e.g. liquid), 1mg
C9074DiscontinueInjection, lumasiran, 0.5 mg
C9132DiscontinueProthrombin complex concentrate (human), kcentra, per i.u. of factor ix activity
M0239DiscontinueIntravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring
Q0239DiscontinueInjection, bamlanivimab-xxxx, 700 mg
CMS – HCPCS2021_JULY_TRANS_ALPHA

Note that M0239 and Q0239 are not payable under Medicare effective April 16, 2021.

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