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Your Title Slide Keep It Short And SweetAgenda
• Current Procedural Terminology (CPT®) and Healthcare Common
Procedure Coding System (HCPCS) Updates
• Monoclonal Antibody (MAB) Updates
• Vaccine and Booster Updates
• Next determination due January 16, 2022
• Allows flexibilities & waivers to continue
ICD-10-CM Updates
U07.1, U09.9
• Code first the specific condition
• Replaces B94.8 Sequelae of other specified infectious and
parasitic diseases
• No specific diagnosis codes for the variants
Chapter 1: Certain Infectious and Parasitic Diseases (A00- B99),
U07.1, U09.9
g. Coronavirus infections
(j) Follow-up visits after COVID-19 infection has resolved for
individuals who previously had COVID-19, without residual
symptom(s) or condition(s), and are being seen for follow-up
evaluation, and COVID-19 test results are negative, assign codes
Z09, Encounter for follow-up examination after completed treatment
for conditions other than malignant neoplasm, and Z86.16, Personal
history of COVID-19.
For follow-up visits for individuals with symptom(s) or
condition(s) related to a previous COVID-19 infection, see
guideline I.C.1.g.1.m.
See Section I.C.21.c.8, Factors influencing health states and
contact with health services, Follow-up
Chapter 1: Certain Infectious and Parasitic Diseases (A00-B99),
U07.1, U09.9
g. Coronavirus infections
(l) Multisystem Inflammatory Syndrome
If an individual with a history of COVID-19 develops MIS, assign
codes M35.81, Multisystem inflammatory syndrome, and U09.9, Post
COVID-19 condition, unspecified.
Chapter 1: Certain Infectious and Parasitic Diseases (A00- B99),
U07.1, U09.9
g. Coronavirus infections
(m) Post COVID-19 Condition
For sequela of COVID-19, or associated symptoms or conditions that
develop following a previous COVID-19 infection, assign a code(s)
for the specific symptom(s) or condition(s) related to the previous
COVID- 19 infection, if known, and code U09.9, Post COVID-19
condition, unspecified.
Code U09.9 should not be assigned for manifestations of an active
(current) COVID-19 infection.
Chapter 1: Certain Infectious and Parasitic Diseases (A00-B99),
U07.1, U09.9
g. Coronavirus infections
If a patient has a condition(s) associated with a previous COVID-19
infection and develops a new active (current) COVID-19 infection,
code U09.9 may be assigned in conjunction with code U07.1,
COVID-19, to identify that the patient also has a condition(s)
associated with a previous COVID-19 infection. Code(s) for the
specific condition(s) associated with the previous COVID-19
infection and code(s) for manifestation(s) of the new active
(current) COVID-19 infection should also be assigned.
Americans with Disabilities Act (ADA)
“…This guidance explains that long COVID can be a disability under
Titles II (state and local government) and III (public
accommodations) of the Americans with Disabilities Act (ADA),
Section 504 of the Rehabilitation Act of 1973 (Section 504), and
Section 1557 of the Patient Protection and Affordable Care Act
(Section 1557). Each of these federal laws protects people with
disabilities from discrimination….”
An individual assessment is necessary to determine disability
ICD-10-CM Publication
• Process update: Applicants may select April or October effective
date for new codes
• Updates effective April 1 are to be published in November
• Provides time for vendors to update and/or publish
CPT/HCPCS Updates COVID-19 Related, After April 2021
CPT® - May 2021 (Novavax)
• 91304 Severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, recombinant
spike protein nanoparticle, saponin-based adjuvant, preservative
free, 5 mcg/0.5 mL dosage, for intramuscular use
• 0041A – First Dose
• 0042A – Second Dose
• 0003A Immunization administration by intramuscular injection of
severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2)
(coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein,
preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted;
third dose
CPT® - August 12, 2021 - Moderna
• 0013A Immunization administration by intramuscular injection of
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
(coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein,
preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted;
booster dose
CPT® - September 2021
• More new codes not active until U.S. Food & Drug
Administration (FDA) approves
• 0004A Immunization administration by intramuscular injection of
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
(coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein,
preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted;
booster dose • Emergency Use Authorization (EUA) given September
22, 2021
• Pfizer
• 0051A First dose
• 0052A Second dose
• 0053A Third dose
• Eliminates need for diluent
CPT® - October 20, 2021
• 91306 Moderna booster vaccine
• 0034A J&J booster vaccine
CPT® - October 20, 2021
CPT® - October 29, 2021
• 91307 Severe acute respiratory syndrome coronavirus 2 (SARS-
CoV2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike
protein, preservative free, 10 mcg/0.2 mL dosage, diluent
reconstituted, tris-sucrose formulation, for intramuscular
use
• 0071A - First dose
• 0072A - Second dose
• Advisory Committee on Immunization Practices (ACIP) meeting today
to discuss
HCPCS – May 6, 2021
• M0246 Intravenous 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
HCPCS – May 26, 2021
• M0247 Intravenous infusion, sotrovimab, includes infusion and
post administration monitoring
• M0248 Intravenous infusion, sotrovimab, 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
HCPCS – June 2021
• Q0244 Injection, casirivimab and imdevimab, 1200 mg – June 3,
2021
• M0201 COVID-19 vaccine administration inside a patient's home;
reported only once per individual home per date of service when
only COVID-19 vaccine administration is performed at the patient's
home – June 8, 2021
HCPCS – June 24, 2021
• Q0249 Injection, tocilizumab, for hospitalized adults and
pediatric patients (2 years of age and older) with COVID- 19 who
are receiving systemic corticosteroids and require supplemental
oxygen, non-invasive or invasive mechanical ventilation, or
extracorporeal membrane oxygenation (ECMO) only, 1 mg
• M0249 Intravenous infusion, tocilizumab, for hospitalized adults
and pediatric patients (2 years of age and older) with COVID-19 who
are receiving systemic corticosteroids and require supplemental
oxygen, non-invasive or invasive mechanical ventilation, or
extracorporeal membrane oxygenation (ECMO) only, includes infusion
and post administration monitoring, first dose
HCPCS – June 24, 2021
• M0250 Intravenous infusion, tocilizumab, for hospitalized adults
and pediatric patients (2 years of age and older) with COVID-19 who
are receiving systemic corticosteroids and require supplemental
oxygen, non-invasive or invasive mechanical ventilation, or
extracorporeal membrane oxygenation (ECMO) only, includes infusion
and post administration monitoring, second dose
• Bill under the vaccine benefit – yes, it’s bizarre
HCPCS – July 30, 2021
• M0240 Intravenous infusion or subcutaneous injection, casirivimab
and imdevimab includes infusion or injection, and post
administration monitoring, subsequent repeat doses
• M0241 Intravenous infusion or subcutaneous injection, casirivimab
and imdevimab includes infusion or injection, 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, subsequent
repeat doses
Revise Place of Service (POS) 02
• Pre-2022
Telehealth
The location where health services and health related services are
provided or received, through telecommunication technology.
•2022
Telehealth Provided Other than in Patient’s Home
The location where health services and health related services are
provided or received, through telecommunication technology. Patient
is not located in their home when receiving health services or
health related services through telecommunication technology.
New Place of Service (POS)
• 10 Telehealth Provided in Patient’s Home
• The location where health services and health related services
are provided or received, through telecommunication technology.
Patient is located in their home (which is a location other than a
hospital or other facility where the patient receives care in a
private residence) when receiving health services or health related
services through telecommunication technology
• Not used for Medicare
• At-home administration (outpatient) $750
• Q0249 Tocilizumab for COVID-19 $6.572
• Drug and administration on claim
General Updates
• June 3, 2021 – Casirivimab and Imdevimab (Regeneron) • U.S. Food
& Drug Administration (FDA) changed dosing regimen to
1200 mg
• Can be administered via infusion or via subcutaneous injection in
limited circumstances
• HCPCS Q0244 released for drug
• Updated descriptions for administration M0243/M0244
General Updates
• July 30, 2021 casirivimab and imdevimab authorized for
post-exposure prophylaxis (PEP) • Initial dose of 1200 mg,
subsequent does 600 mg once every 4
weeks of ongoing exposure
• Facility - $450
• Home - $750
General Updates
• September 16, 2021 bamlanivimab and etesevimab authorized for PEP
• No specific codes released
• M0245 Intravenous infusion, bamlanivimab and etesevimab, includes
infusion and post administration monitoring
• M0246 Intravenous 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
General Updates
• Inpatient Prospective Payment System (IPPS) Final Rule • Coverage
of add-on payment for COVID-19 treatments will be paid
through the end of the fiscal year the public health emergency
(PHE) ends
• Veklury® (remdesivir) added to the New COVID-19 Technology Add-
on Payment (NCTAP) list • When NCTAP is received, the amount of the
New COVID-19 Treatment Add-on
Payment (NCTAP) will be reduced by $2,028
• No duplicate payment of 20% increase for COVID-19 patients
• Because CMS considers monoclonal antibody products to to be
COVID-19 vaccines, they aren’t eligible for the NCTAP
Medicare Advantage
• Effective January 1, 2022, submit claims to Medicare Advantage
(MA) plan • Monoclonal Antibody COVID-19 Infusions
• COVID-19 Vaccine Administration • Part A Home Health and Hospice
claims should include Condition Code 78
NEW COVERAGE NOT IMPLEMENTED BY MANAGED CARE PLAN
• Original Medicare will deny claims
• Verify MA plan claims submission requirements
Casirivimab and Imdevimab (Regeneron)
• Must be administered together • In a setting where healthcare
providers have immediate access to
medications to treat a severe infusion reaction
• In accordance with the authorized Fact Sheets
• Treating mild to moderate COVID-19 in • Adults
• Pediatric patients (12 years of age and older, weighing at least
40 kg)
• Positive results of direct SARS-CoV-2 viral testing
• At risk for progressing to severe COVID-19 and/or
hospitalization
Casirivimab and Imdevimab (Regeneron)
• Post-Exposure Prophylaxis (PEP) of COVID-19 • Not fully
vaccinated or not expected to mount an adequate immune
response to vaccination and
• Have been exposed to an individual infected with SARS-CoV-2
consistent with close contact criteria per Centers for Disease
Control and Prevention (CDC) or
• Who are at high risk of exposure to an individual infected with
SARSCoV-2 because of occurrence of SARS-CoV-2 infection in other
individuals in the same institutional setting (for example, nursing
homes, prisons)
• Not authorized for pre-exposure prophylaxis for prevention of
COVID- 19
Casirivimab and Imdevimab (Regeneron)
• NOT APPROVED for • Patients who are hospitalized due to
COVID-19
• Patients who require oxygen therapy due to COVID-19
• Patients who require an increase in baseline oxygen flow rate due
to COVID-19 in those patients on chronic oxygen therapy due to
underlying non-COVID-19-related comorbidity
• Does not replace vaccination
Bamlanivimab and Etesevimab (Eli Lilly)
• Must be administered together • In a setting where healthcare
providers have immediate access to
medications to treat a severe infusion reaction
• In accordance with the authorized Fact Sheets
• Treating mild to moderate COVID-19 in • Adults
• Pediatric patients (12 years of age and older, weighing at least
40 kg)
• Positive results of direct SARS-CoV-2 viral testing
• At risk for progressing to severe COVID-19 and/or
hospitalization
Bamlanivimab and Etesevimab (Eli Lilly)
• Bamlanivimab and etesevimab are authorized for use only in
states, territories, and U.S. jurisdictions in which the combined
frequency of variants resistant to bamlanivimab and etesevimab
administered together is less than or equal to 5%, as determined by
FDA. A list of states, territories and U.S. jurisdictions in which
bamlanivimab and etesevimab are and are not currently authorized is
available on FDA’s website at:
https://www.fda.gov/media/151719/download
• Post-Exposure Prophylaxis of COVID-19 • Not fully vaccinated or
not expected to mount an adequate immune
response to vaccination and
• Have been exposed to an individual infected with SARS- CoV-2
consistent with close contact criteria per Centers for Disease
Control and Prevention (CDC) or
• Who are at high risk of exposure to an individual infected with
SARSCoV-2 because of occurrence of SARS-CoV-2 infection in other
individuals in the same institutional setting (for example, nursing
homes, prisons)
Bamlanivimab and Etesevimab (Eli Lilly)
• NOT APPROVED for • Patients who are hospitalized due to
COVID-19
• Patients who require oxygen therapy due to COVID-19
• Patients who require an increase in baseline oxygen flow rate due
to COVID-19 in those patients on chronic oxygen therapy due to
underlying non-COVID-19 related comorbidity
• Not a substitute for vaccination
Sotrovimab (GSK)
• Treating mild to moderate COVID-19 in • Adults
• Pediatric patients (12 years of age and older, weighing at least
40 kg)
• Positive results of direct SARS-CoV-2 viral testing
• At risk for progressing to severe COVID-19 and/or
hospitalization
• Administered in a setting where healthcare providers have
immediate access to medications to treat a severe infusion
reaction
• In accordance with the authorized Fact Sheets
Sotrovimab (GSK)
• NOT APPROVED for • Patients who are hospitalized due to
COVID-19
• Patients who require oxygen therapy due to COVID-19
• Patients who require an increase in baseline oxygen flow rate due
to COVID-19 in those patients on chronic oxygen therapy due to
underlying non-COVID-19-related comorbidity
Tocilizumab (Genentech)
• In accordance with the Fact Sheets
• Treat COVID-19 in hospitalized patients • Adults and pediatric
patients (2 years of age and older)
• Severe COVID-19
Tocilizumab (Genentech)
• Maximum dosage in COVID-19 patients is 800 mg per infusion
• If symptoms worsen or do not improve, one additional infusion may
be given at least 8 hours after initial infusion
• “Under the terms of the EUA, tocilizumab may only be infused in
the hospital setting, in limited clinical situations. Providers may
not furnish tocilizumab in the “home or residence,” including homes
or residences that have been made provider-based to the hospital
during the COVID-19 PHE. As a result, Medicare hasn’t created a
separate HCPCS code for billing for the higher Medicare payment
amount for administering tocilizumab in the home.”
Frequently Asked Question (FAQ)
• Can we administer tocilizumab to an outpatient? • No, because the
EUA is for hospitalized patients
• What if the patient came in through the Emergency Department (ED)
and is waiting for an inpatient bed? • If the patient has an order
for an inpatient admission and is waiting in
the ED for bed placement, the patient would need to be receiving
the level of care of an inpatient for the administration of
tocilizumab to be covered under the EUA
COVID-19 Vaccine and Booster Updates
Third Dose and Booster Confusion
Vaccine & Booster Updates
• What is a third dose? • Initial immune response following a
two-dose primary vaccine is likely
to be insufficient
• Immunocompromised or other clinical indications
• What is a booster? • Initial immune response to the vaccine was
sufficient but has waned
over time
Mixing Doses
• Coding - report the appropriate booster dose administration for
the vaccine product provided
• First, second, third vaccination of Moderna, but booster Pfizer –
report Pfizer booster
• Sequence of shot, then manufacturer
Moderna or Pfizer Booster Eligibility
•65+ years of age
•18+ working or living in high-risk settings
•First responders
•Education staff
•Down Syndrome
•Heart Conditions
•HIV infection
•Immunocompromised state
•Overweight/obesity
•Pregnancy
•Smoking (current or former)
•Solid organ or blood stem cell transplant
•Stroke or cerebrovascular disease, which affects blood flow to the
brain
•Substance abuse disorder
•J&J – 2 months after original dose
M0201 COVID-19 Vaccine Admin Inside Patient’s Home
• Report with the CPT® code for COVID-19 vaccine product and
dose
• Report once per home per date of service (DOS)
• More than one Medicare patient in a single home on the same day
has separate instructions
• Instructions change August 24, 2021
• $35
M0201 COVID-19 Vaccine Admin Inside Patient’s Home
• June 8 through August 23, 2021: • Report M0201 once per
individual home or living unit
• On or after August 24, 2021: • Only report if fewer than 10
patients at the same group living location
• May report for each patient in an individual home
• Maximum of 5 times if multiple patients vaccinated in the same
home or communal space
M0201 COVID-19 Vaccine Admin Inside Patient’s Home
• The patient has difficulty leaving the home to get the vaccine,
which could mean any of these: • Condition restricting ability to
leave home without a supportive device
or help from a paid or unpaid caregiver
• More susceptible to contracting COVID-19
• Generally unable to leave the home, and it requires a
considerable and taxing effort
• Patient hard-to-reach due to disability or face clinical,
socioeconomic, or geographical barriers to getting a COVID-19
vaccine in settings other than their home. These patients face
challenges that significantly reduce their ability to get
vaccinated outside the home, such as challenges with
transportation, communication, or caregiving
M0201 COVID-19 Vaccine Admin Inside Patient’s Home
• Locations • A private residence
• Temporary lodging (hotel, hostel, campground)
• An apartment in an apartment complex or a unit in an assisted
living facility, group home or non-Medicaid nursing facility
• A Medicare patient’s home that’s made provider-based to a
hospital during the COVID-19 PHE
• Added effective August 24, 2021 • Communal spaces of a multi-unit
or communal living arrangement
• Assisted living facilities participating in the CDC’s Pharmacy
Partnership for Long-Term Care Program when their residents are
vaccinated through this program
Administration in Patient’s Home
• The patient has difficulty leaving the home to get the vaccine •
A condition restricts their ability to leave home without a
supportive
device or help from a paid or unpaid caregiver
• They are more susceptible to contracting a pandemic disease like
COVID-19
• They are generally unable to leave the home, and if they do leave
home it requires a considerable and taxing effort
• Don’t have to certify as homebound, but document why seen in
home
M0201 COVID-19 Vaccine Admin Inside Patient’s Home
• Two patients in the same home, $150 • 2 x $35 in-home vaccine
administration, plus 2 x $40 vaccine
• Nine patients in the same home or communal space, $535 • 9 x $35
in-home vaccine administration, plus 9 x $40 vaccine
• Twelve patients in the same home, $515 • 1 x $35 in-home vaccine
administration, plus 12 x $40 vaccine
• 5 patients in communal space, 3 in individual rooms, $600 • 5 x
$35 in-home vaccine administration in communal space, plus 3
x
$35 in-home vaccine administration in individual homes, plus 8 x
$40 vaccine
References
https://www.cms.gov/medicare/medicare-part-b-drug-
average-sales-price/covid-19-vaccines-and-monoclonal-
antibodies
https://www.hhs.gov/civil-rights/for-providers/civil-rights-
covid19/guidance-long-covid-
disability/index.html#footnote10_0ac8mdc
https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies
https://www.ama-assn.org/practice-management/cpt/covid-
19-cpt-coding-and-guidance
https://www.ama-assn.org/practice-management/cpt/covid-
19-cpt-vaccine-and-immunization-codes