-
EFFECTIVE OCTOBER 1, 2020, CMS APPROVES NUZYRA IV FOR NEW
TECHNOLOGY ADD-ON PAYMENT (NTAP)1
• Medicare will now provide an add-on payment for NUZYRA IV of
up to $1,552.50, per qualifying case, toInpatient Prospective
Payment System (IPPS)-participating acute care hospitals
• Provides an incremental reimbursement amount, in addition to
the applicable MS-DRG–based reimbursement, forMedicare inpatient
cases paid under the IPPS that involve the use of an eligible new
medical service or technology
INDICATIONS
NUZYRA® is a tetracycline-class antibacterial indicated for the
treatment of adult patients with the following infections caused by
susceptible microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the
following: Streptococcus pneumoniae, Staphylococcus aureus
(methicillin-susceptible isolates), Haemophilus influenzae,
Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella
pneumophila, Mycoplasma pneumoniae, and Chlamydophila
pneumoniae.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
caused by the following: Staphylococcus aureus
(methicillin-susceptible and -resistant isolates), Staphylococcus
lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp.
(includes S. anginosus, S. intermedius, and S. constellatus),
Enterococcus faecalis, Enterobacter cloacae, and Klebsiella
pneumoniae.
USAGETo reduce the development of drug-resistant bacteria and
maintain the effectiveness of NUZYRA and other antibacterial drugs,
NUZYRA should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by susceptible
bacteria.
Please see Important Safety Information on the following pages
and accompanying Full Prescribing Information.
CMS=Centers for Medicare & Medicaid Services;
MS-DRG=Medicare Severity Diagnosis Related Group.
ABOUT NTAP1
• Helps ensure adequate payment for new medical services and
technologies used to treat Medicare beneficiariesin the inpatient
hospital setting for eligible hospitals
• Offers a temporary stop-gap measure until MS-DRG can be
recalibrated
NUZYRA HAS BEEN GRANTED NTAP STATUS
IMPORTANT SAFETY INFORMATION (cont.) DRUG INTERACTIONS Patients
who are on anticoagulant therapy may require downward adjustment of
their anticoagulant dosage while taking NUZYRA.
Absorption of tetracyclines, including NUZYRA is impaired by
antacids containing aluminum, calcium, or magnesium, bismuth
subsalicylate and iron containing preparations.
USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not
recommended during treatment with NUZYRA.
Please see accompanying Full Prescribing Information.
NUZYRA is contraindicated in patients with known
hypersensitivity to omadacycline or tetracycline-class
antibacterial drugs, or to any of the excipients.
US-NUA-0385 09/20
References: 1. Data on file. Paratek Pharmaceuticals, Inc,
Boston, MA. 2. Centers for Medicare & Medicaid Services.
Increasing access to innovative antibiotics for hospital inpatients
using New Technology Add-On Payments: frequently asked questions.
MLN Matters Number: SE20004. Article Release Date: January 21,
2020. Accessed September 2, 2020.
https://www.cms.gov/files/document/SE20004.pdf 3. Centers for
Medicare & Medicaid Services. Medicare Claims Processing
Manual: Chapter 3 – Inpatient Hospital Billing. Rev. 10210. Issued
July 10, 2020. Accessed September 3, 2020.
https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c03.pdf
4. NUZYRA [Prescribing Information]. Boston, MA: Paratek
Pharmaceuticals, Inc.
© 2020 Paratek Pharmaceuticals, Inc. All rights
reserved.PARATEK® and the hexagon logo are registered trademarks of
Paratek Pharmaceuticals, Inc.NUZYRA® and its design logo are
registered trademarks of Paratek Pharmaceuticals, Inc.
AVAILABLE AS A MONOTHERAPY IN IV AND ORAL FORMULATIONS4
ACTIVITY AGAINST SELECT GRAM-POSITIVES, GRAM-NEGATIVES, AND
ATYPICALS, INCLUDING DRUG-RESISTANT STRAINS4
NO DOSAGE ADJUSTMENT REQUIRED FOR PATIENTS WITH RENAL OR HEPATIC
IMPAIRMENT4
MAY BE USED AS AN ALTERNATIVE FOR PATIENTS WITH FLUOROQUINOLONE,
BETA-LACTAM, OR SULFA ALLERGIES4
START YOUR APPROPRIATE PATIENTS WITH CABP AND ABSSSION NUZYRA
TODAY
FROM HOSPITAL TO HOMETM WITH NUZYRA® (omadacycline)
NTAP DETAILS FOR NUZYRA IV1,3
Eligible facilitiesHospitals that are reimbursed under the IPPS
(Inpatient Prospective Payment System). Critical Access Hospitals
(CAH), excluded cancer hospitals, long-term acute care hospitals,
VA/DoD facilities, and hospitals in the state of Maryland are not
eligible
Setting of careAcute care hospital inpatient setting
Qualified patientsTraditional (fee for service) Medicare
beneficiaries where the cost of the case exceeds the MS-DRG payment
for the case
Amount of the NTAP paymentThe maximum payment is $1,552.50 for a
qualifying patient treated with NUZYRA IV
Effective periodOctober 1, 2020 through September 30, 2021
ICD-10-PCS CODES AND ELIGIBILITY GUIDELINES1
ELIGIBLE HOSPITALS CAN REPORT THE USE OF NUZYRA IV BY RECORDING
AN ICD-10-PCS CODE ON THE CLAIM
You are solely responsible for determining the appropriate codes
and for any action you take in billing. The information provided
here is not intended to be definitive or exhaustive, and is not
intended to replace the guidance of a qualified professional
advisor. Paratek and its agents make no warranties or guarantees,
express or implied, concerning the accuracy or appropriateness of
this information for your particular use. The use of this
information does not guarantee payment or that any payment received
will cover your costs. The information provided here is compiled
from the sources believed to be accurate, but Paratek makes no
representation that it is accurate. This information is subject to
change. Consult the relevant manual and other guidelines for a
description of each code to determine the appropriateness of a
particular code and for information on additional codes.
ICD-10-PCS CODEDESCRIPTOR
XW033B6Introduction of omadacycline anti-infective into
peripheral vein, percutaneous approach, new technology group 6
XW043B6Introduction of omadacycline anti-infective into central
vein, percutaneous approach, new technology group 6
IMPORTANT SAFETY INFORMATION (cont.) WARNINGS AND PRECAUTIONS
(cont.) Hypersensitivity reactions have been reported with NUZYRA.
Life-threatening hypersensitivity (anaphylactic)reactions have been
reported with other tetracycline-class antibacterial drugs. NUZYRA
is structurally similar to other tetracycline-class antibacterial
drugs and is contraindicated in patients with known
hypersensitivity to tetracycline-class antibacterial drugs.
Discontinue NUZYRA if an allergic reaction occurs.
Clostridioides difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis. Evaluate if
diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class of
antibacterial drugs and may have similar adverse reactions. Adverse
reactions including photosensitivity, pseudotumor cerebri, and
anti-anabolic action (which has led to increased BUN, azotemia,
acidosis, hyperphosphatemia, pancreatitis, and abnormal liver
function tests), have been reported for other tetracycline-class
antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA
if any of these adverse reactions are suspected.
Prescribing NUZYRA in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
ADVERSE REACTIONS The most common adverse reactions (incidence
≥2%) are nausea, vomiting, infusion site reactions, alanine
aminotransferase increased, aspartate aminotransferase increased,
gamma-glutamyl transferase increased, hypertension, headache,
diarrhea, insomnia, and constipation.
173116.indd 1173116.indd 1 9/21/20 1:51 PM9/21/20 1:51 PM
https://www.nuzyra.com/nuzyra-pi.pdf
-
NTAP=New Technology Add-On Payment; QIDP=qualified infectious
disease product; MS-DRG=Medicare Severity Diagnosis Related
Group.
Please see Important Safety Information continued on back cover
and accompanying Full Prescribing Information.
PAYMENT AND TIMING1,2
The NTAP will provide certain eligible hospitals with a payment,
in addition to the MS-DRG reimbursement, of up to 75% of the cost
of NUZYRA IV for a period of 2 to 3 years, effective in the 2021
fiscal year (FY) starting on October 1, 2020.
The maximum additional payment for FY 2021 (beginning October 1,
2020) is $1,552.50 per admission. If the total covered costs of the
case do not exceed the MS-DRG payment, then no additional payment
is made for the admission.
IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS NUZYRA is
contraindicated in patients with known hypersensitivity to
omadacycline or tetracycline-class antibacterial drugs, or to any
of the excipients.
WARNINGS AND PRECAUTIONS Mortality imbalance was observed in the
CABP clinical trial with eight deaths (2%) occurring in patients
treated with NUZYRA compared to four deaths (1%) in patients
treated with moxifloxacin. The cause of the mortality imbalance has
not been established. All deaths, in both treatment arms, occurred
in patients > 65 years of age; most patients had multiple
comorbidities. The causes of death varied and included worsening
and/or complications of infection and underlying conditions.
Closely monitor clinical response to therapy in CABP patients,
particularly in those at higher risk for mortality.
The use of NUZYRA during tooth development (last half of
pregnancy, infancy and childhood to the age of 8 years) may cause
permanent discoloration of the teeth (yellow-gray-brown) and enamel
hypoplasia.
The use of NUZYRA during the second and third trimester of
pregnancy, infancy and childhood up to the age of 8 years may cause
reversible inhibition of bone growth.
NUZYRA® (omadacycline) IV RECEIVED NTAP STATUS BASED ON1,2:
QIDP DESIGNATION NUZYRA received FDA QIDP designation because it
is an innovative antibiotic for hospital inpatients
COST CRITERIONExisting MS-DRG payment for services involving
NUZYRA IV is inadequate to meet the cost of services
ADDITIONAL PATIENT SUPPORT AND REIMBURSEMENT SERVICES ARE ALSO
AVAILABLE THROUGH NUZYRA CENTRALTM
FOR MORE INFORMATION AND SUPPORT FROM NUZYRA CENTRALTM, CALL
1-877-4-NUZYRA
GLUE
GLUE
173116.indd 2173116.indd 2 9/21/20 1:51 PM9/21/20 1:51 PM
https://www.nuzyra.com/nuzyra-pi.pdf
-
EFFECTIVE OCTOBER 1, 2020, CMS APPROVES NUZYRA IV FOR NEW
TECHNOLOGY ADD-ON PAYMENT (NTAP)1
• Medicare will now provide an add-on payment for NUZYRA IV of
up to $1,552.50, per qualifying case, to Inpatient Prospective
Payment System (IPPS)-participating acute care hospitals
• Provides an incremental reimbursement amount, in addition to
the applicable MS-DRG–based reimbursement, for Medicare inpatient
cases paid under the IPPS that involve the use of an eligible new
medical service or technology
INDICATIONS
NUZYRA® is a tetracycline-class antibacterial indicated for the
treatment of adult patients with the following infections caused by
susceptible microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the
following: Streptococcus pneumoniae, Staphylococcus aureus
(methicillin-susceptible isolates), Haemophilus influenzae,
Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella
pneumophila, Mycoplasma pneumoniae, and Chlamydophila
pneumoniae.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
caused by the following: Staphylococcus aureus
(methicillin-susceptible and -resistant isolates), Staphylococcus
lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp.
(includes S. anginosus, S. intermedius, and S. constellatus),
Enterococcus faecalis, Enterobacter cloacae, and Klebsiella
pneumoniae.
USAGETo reduce the development of drug-resistant bacteria and
maintain the effectiveness of NUZYRA and other antibacterial drugs,
NUZYRA should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by susceptible
bacteria.
Please see Important Safety Information on the following pages
and accompanying Full Prescribing Information.
CMS=Centers for Medicare & Medicaid Services;
MS-DRG=Medicare Severity Diagnosis Related Group.
ABOUT NTAP1
• Helps ensure adequate payment for new medical services and
technologies used to treat Medicare beneficiaries in the inpatient
hospital setting for eligible hospitals
• Offers a temporary stop-gap measure until MS-DRG can be
recalibrated
NUZYRA HAS BEEN GRANTED NTAP STATUS
IMPORTANT SAFETY INFORMATION (cont.) DRUG INTERACTIONS Patients
who are on anticoagulant therapy may require downward adjustment of
their anticoagulant dosage while taking NUZYRA.
Absorption of tetracyclines, including NUZYRA is impaired by
antacids containing aluminum, calcium, or magnesium, bismuth
subsalicylate and iron containing preparations.
USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not
recommended during treatment with NUZYRA.
Please see accompanying Full Prescribing Information.
NUZYRA is contraindicated in patients with known
hypersensitivity to omadacycline or tetracycline-class
antibacterial drugs, or to any of the excipients.
US-NUA-0385 09/20
References: 1. Data on file. Paratek Pharmaceuticals, Inc,
Boston, MA. 2. Centers for Medicare & Medicaid Services.
Increasing access to innovative antibiotics for hospital inpatients
using New Technology Add-On Payments: frequently asked questions.
MLN Matters Number: SE20004. Article Release Date: January 21,
2020. Accessed September 2, 2020.
https://www.cms.gov/files/document/SE20004.pdf 3. Centers for
Medicare & Medicaid Services. Medicare Claims Processing
Manual: Chapter 3 – Inpatient Hospital Billing. Rev. 10210. Issued
July 10, 2020. Accessed September 3, 2020.
https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c03.pdf
4. NUZYRA [Prescribing Information]. Boston, MA: Paratek
Pharmaceuticals, Inc.
© 2020 Paratek Pharmaceuticals, Inc. All rights
reserved.PARATEK® and the hexagon logo are registered trademarks of
Paratek Pharmaceuticals, Inc.NUZYRA® and its design logo are
registered trademarks of Paratek Pharmaceuticals, Inc.
AVAILABLE AS A MONOTHERAPY IN IV AND ORAL FORMULATIONS4
ACTIVITY AGAINST SELECT GRAM-POSITIVES, GRAM-NEGATIVES, AND
ATYPICALS, INCLUDING DRUG-RESISTANT STRAINS4
NO DOSAGE ADJUSTMENT REQUIRED FOR PATIENTS WITH RENAL OR HEPATIC
IMPAIRMENT4
MAY BE USED AS AN ALTERNATIVE FOR PATIENTS WITH FLUOROQUINOLONE,
BETA-LACTAM, OR SULFA ALLERGIES4
START YOUR APPROPRIATE PATIENTS WITH CABP AND ABSSSI ON NUZYRA
TODAY
FROM HOSPITAL TO HOMETM WITH NUZYRA® (omadacycline)
NTAP DETAILS FOR NUZYRA IV1,3
Eligible facilitiesHospitals that are reimbursed under the IPPS
(Inpatient Prospective Payment System). Critical Access Hospitals
(CAH), excluded cancer hospitals, long-term acute care hospitals,
VA/DoD facilities, and hospitals in the state of Maryland are not
eligible
Setting of care Acute care hospital inpatient setting
Qualified patients Traditional (fee for service) Medicare
beneficiaries where the cost of the case exceeds the MS-DRG payment
for the case
Amount of the NTAP payment The maximum payment is $1,552.50 for
a qualifying patient treated with NUZYRA IV
Effective period October 1, 2020 through September 30, 2021
ICD-10-PCS CODES AND ELIGIBILITY GUIDELINES1
ELIGIBLE HOSPITALS CAN REPORT THE USE OF NUZYRA IV BY RECORDING
AN ICD-10-PCS CODE ON THE CLAIM
You are solely responsible for determining the appropriate codes
and for any action you take in billing. The information provided
here is not intended to be definitive or exhaustive, and is not
intended to replace the guidance of a qualified professional
advisor. Paratek and its agents make no warranties or guarantees,
express or implied, concerning the accuracy or appropriateness of
this information for your particular use. The use of this
information does not guarantee payment or that any payment received
will cover your costs. The information provided here is compiled
from the sources believed to be accurate, but Paratek makes no
representation that it is accurate. This information is subject to
change. Consult the relevant manual and other guidelines for a
description of each code to determine the appropriateness of a
particular code and for information on additional codes.
ICD-10-PCS CODE DESCRIPTOR
XW033B6 Introduction of omadacycline anti-infective into
peripheral vein, percutaneous approach, new technology group 6
XW043B6 Introduction of omadacycline anti-infective into central
vein, percutaneous approach, new technology group 6
IMPORTANT SAFETY INFORMATION (cont.) WARNINGS AND PRECAUTIONS
(cont.) Hypersensitivity reactions have been reported with NUZYRA.
Life-threatening hypersensitivity (anaphylactic) reactions have
been reported with other tetracycline-class antibacterial drugs.
NUZYRA is structurally similar to other tetracycline-class
antibacterial drugs and is contraindicated in patients with known
hypersensitivity to tetracycline-class antibacterial drugs.
Discontinue NUZYRA if an allergic reaction occurs.
Clostridioides difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis. Evaluate if
diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class of
antibacterial drugs and may have similar adverse reactions. Adverse
reactions including photosensitivity, pseudotumor cerebri, and
anti-anabolic action (which has led to increased BUN, azotemia,
acidosis, hyperphosphatemia, pancreatitis, and abnormal liver
function tests), have been reported for other tetracycline-class
antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA
if any of these adverse reactions are suspected.
Prescribing NUZYRA in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
ADVERSE REACTIONS The most common adverse reactions (incidence
≥2%) are nausea, vomiting, infusion site reactions, alanine
aminotransferase increased, aspartate aminotransferase increased,
gamma-glutamyl transferase increased, hypertension, headache,
diarrhea, insomnia, and constipation.
173116.indd 1 173116.indd 19/21/20 1:51 PM 9/21/20 1:51 PM
-
EFFECTIVE OCTOBER 1, 2020, CMS APPROVES NUZYRA IV FOR NEW
TECHNOLOGY ADD-ON PAYMENT (NTAP)1
• Medicare will now provide an add-on payment for NUZYRA IV of
up to $1,552.50, per qualifying case, to Inpatient Prospective
Payment System (IPPS)-participating acute care hospitals
• Provides an incremental reimbursement amount, in addition to
the applicable MS-DRG–based reimbursement, for Medicare inpatient
cases paid under the IPPS that involve the use of an eligible new
medical service or technology
INDICATIONS
NUZYRA® is a tetracycline-class antibacterial indicated for the
treatment of adult patients with the following infections caused by
susceptible microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the
following: Streptococcus pneumoniae, Staphylococcus aureus
(methicillin-susceptible isolates), Haemophilus influenzae,
Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella
pneumophila, Mycoplasma pneumoniae, and Chlamydophila
pneumoniae.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
caused by the following: Staphylococcus aureus
(methicillin-susceptible and -resistant isolates), Staphylococcus
lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp.
(includes S. anginosus, S. intermedius, and S. constellatus),
Enterococcus faecalis, Enterobacter cloacae, and Klebsiella
pneumoniae.
USAGETo reduce the development of drug-resistant bacteria and
maintain the effectiveness of NUZYRA and other antibacterial drugs,
NUZYRA should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by susceptible
bacteria.
Please see Important Safety Information on the following pages
and accompanying Full Prescribing Information.
CMS=Centers for Medicare & Medicaid Services;
MS-DRG=Medicare Severity Diagnosis Related Group.
ABOUT NTAP1
• Helps ensure adequate payment for new medical services and
technologies used to treat Medicare beneficiaries in the inpatient
hospital setting for eligible hospitals
• Offers a temporary stop-gap measure until MS-DRG can be
recalibrated
NUZYRA HAS BEEN GRANTED NTAP STATUS
IMPORTANT SAFETY INFORMATION (cont.) DRUG INTERACTIONS Patients
who are on anticoagulant therapy may require downward adjustment of
their anticoagulant dosage while taking NUZYRA.
Absorption of tetracyclines, including NUZYRA is impaired by
antacids containing aluminum, calcium, or magnesium, bismuth
subsalicylate and iron containing preparations.
USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding is not
recommended during treatment with NUZYRA.
Please see accompanying Full Prescribing Information.
NUZYRA is contraindicated in patients with known
hypersensitivity to omadacycline or tetracycline-class
antibacterial drugs, or to any of the excipients.
US-NUA-0385 09/20
References: 1. Data on file. Paratek Pharmaceuticals, Inc,
Boston, MA. 2. Centers for Medicare & Medicaid Services.
Increasing access to innovative antibiotics for hospital inpatients
using New Technology Add-On Payments: frequently asked questions.
MLN Matters Number: SE20004. Article Release Date: January 21,
2020. Accessed September 2, 2020.
https://www.cms.gov/files/document/SE20004.pdf 3. Centers for
Medicare & Medicaid Services. Medicare Claims Processing
Manual: Chapter 3 – Inpatient Hospital Billing. Rev. 10210. Issued
July 10, 2020. Accessed September 3, 2020.
https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c03.pdf
4. NUZYRA [Prescribing Information]. Boston, MA: Paratek
Pharmaceuticals, Inc.
© 2020 Paratek Pharmaceuticals, Inc. All rights
reserved.PARATEK® and the hexagon logo are registered trademarks of
Paratek Pharmaceuticals, Inc.NUZYRA® and its design logo are
registered trademarks of Paratek Pharmaceuticals, Inc.
AVAILABLE AS A MONOTHERAPY IN IV AND ORAL FORMULATIONS4
ACTIVITY AGAINST SELECT GRAM-POSITIVES, GRAM-NEGATIVES, AND
ATYPICALS, INCLUDING DRUG-RESISTANT STRAINS4
NO DOSAGE ADJUSTMENT REQUIRED FOR PATIENTS WITH RENAL OR HEPATIC
IMPAIRMENT4
MAY BE USED AS AN ALTERNATIVE FOR PATIENTS WITH FLUOROQUINOLONE,
BETA-LACTAM, OR SULFA ALLERGIES4
START YOUR APPROPRIATE PATIENTS WITH CABP AND ABSSSI ON NUZYRA
TODAY
FROM HOSPITAL TO HOMETM WITH NUZYRA® (omadacycline)
NTAP DETAILS FOR NUZYRA IV1,3
Eligible facilitiesHospitals that are reimbursed under the IPPS
(Inpatient Prospective Payment System). Critical Access Hospitals
(CAH), excluded cancer hospitals, long-term acute care hospitals,
VA/DoD facilities, and hospitals in the state of Maryland are not
eligible
Setting of careAcute care hospital inpatient setting
Qualified patientsTraditional (fee for service) Medicare
beneficiaries where the cost of the case exceeds the MS-DRG payment
for the case
Amount of the NTAP paymentThe maximum payment is $1,552.50 for a
qualifying patient treated with NUZYRA IV
Effective periodOctober 1, 2020 through September 30, 2021
ICD-10-PCS CODES AND ELIGIBILITY GUIDELINES1
ELIGIBLE HOSPITALS CAN REPORT THE USE OF NUZYRA IV BY RECORDING
AN ICD-10-PCS CODE ON THE CLAIM
You are solely responsible for determining the appropriate codes
and for any action you take in billing. The information provided
here is not intended to be definitive or exhaustive, and is not
intended to replace the guidance of a qualified professional
advisor. Paratek and its agents make no warranties or guarantees,
express or implied, concerning the accuracy or appropriateness of
this information for your particular use. The use of this
information does not guarantee payment or that any payment received
will cover your costs. The information provided here is compiled
from the sources believed to be accurate, but Paratek makes no
representation that it is accurate. This information is subject to
change. Consult the relevant manual and other guidelines for a
description of each code to determine the appropriateness of a
particular code and for information on additional codes.
ICD-10-PCS CODEDESCRIPTOR
XW033B6Introduction of omadacycline anti-infective into
peripheral vein, percutaneous approach, new technology group 6
XW043B6Introduction of omadacycline anti-infective into central
vein, percutaneous approach, new technology group 6
IMPORTANT SAFETY INFORMATION (cont.) WARNINGS AND PRECAUTIONS
(cont.) Hypersensitivity reactions have been reported with NUZYRA.
Life-threatening hypersensitivity (anaphylactic) reactions have
been reported with other tetracycline-class antibacterial drugs.
NUZYRA is structurally similar to other tetracycline-class
antibacterial drugs and is contraindicated in patients with known
hypersensitivity to tetracycline-class antibacterial drugs.
Discontinue NUZYRA if an allergic reaction occurs.
Clostridioides difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis. Evaluate if
diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class of
antibacterial drugs and may have similar adverse reactions. Adverse
reactions including photosensitivity, pseudotumor cerebri, and
anti-anabolic action (which has led to increased BUN, azotemia,
acidosis, hyperphosphatemia, pancreatitis, and abnormal liver
function tests), have been reported for other tetracycline-class
antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA
if any of these adverse reactions are suspected.
Prescribing NUZYRA in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
ADVERSE REACTIONS The most common adverse reactions (incidence
≥2%) are nausea, vomiting, infusion site reactions, alanine
aminotransferase increased, aspartate aminotransferase increased,
gamma-glutamyl transferase increased, hypertension, headache,
diarrhea, insomnia, and constipation.
173116.indd 1173116.indd 1 9/21/20 1:51 PM9/21/20 1:51 PM
https://www.nuzyra.com/nuzyra-pi.pdf