LCD Reference Article Article

Antibacterial Drugs

A54812

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Draft Article
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Source Article ID
N/A
Article ID
A54812
Original ICD-9 Article ID
Not Applicable
Article Title
Antibacterial Drugs
Article Type
Article
Original Effective Date
01/01/2016
Revision Effective Date
02/26/2018
Revision Ending Date
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Retirement Date
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Article Text

ORBACTIV® (oritavancin)


Orbactiv® (oritavancin) is a semisynthetic lipoglycopeptide antibacterial drug. It exerts concentration-dependent bactericidal activity in vitro against S. aureus, S. pyogenes, and E. faecalis.
Orbactiv® is specifically indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:
Staphylococcus aureus (including methicillin-susceptible and methicillin–resistant isolates)
• Streptococcus pyogenes
• Streptococcus agalactiae
• Streptococcus dysgalactiae
• Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
• Enterococcus faecalis (vancomycin-susceptible isolates only)

Orbactiv® is supplied as a solution for intravenous infusion. The recommended dose is a single 1200 mg dose administered by intravenous infusion over three hours in patients 18 years and older.

DALVANCE® (dalbavancin)


Dalvance® (dalbavancin) is a lipoglycopeptide antibacterial drug proposed for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:
Staphylococcus aureus (including methicillin-resistant [MRSA] isolates)
• Streptococcus pyogenes
• Streptococcus agalactiae
• Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus)

• Enterococcus faecalis (vancomycin-susceptible isolates only)

Because of its long elimination half-life, the dosing regimen is 1000 mg on Day 1 and 500 mg on Day 8, administered intravenously (IV) over 30 minutes.

VIBATIV® (telavancin)


Vibativ® (telavancin) is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby Vibativ both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. Vibativ® is specifically indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:
Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)
• Streptococcus pyogenes
• Streptococcus agalactiae
• Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
• Enterococcus faecalis
(vancomycin-susceptible isolates only)
• Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus.
Vibativ® is supplied as a powder for reconstitution onto a solution designed for intravenous administration. The recommended initial dose is 10 mg/kg administered over a 60-minute period in patients >18 years of age by intravenous infusion once every 24 hours for 7 to 14 days.

SIVEXTRO® (tedizolid) 

Sivextro® (tedizolid) is an oxazolidinone-class antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:
Staphylococcus aureus (including methicillin-susceptible and methicillin–resistant isolates)
• Streptococcus pyogenes
• Streptococcus agalactiae
• Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
• Enterococcus faecalis
(vancomycin-susceptible isolates only).
The recommended dosage is 200 mg administered once daily for 6 days. Sivextro® can be given orally (with or without food) or as an intravenous (IV) infusion over 1 hour for patients 18 years of age or older.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of these drugs-oritavancin, dalbavancin, telavancin and tedizolid should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

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Coding Information

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Revision History Information

Revision History Date Revision History Number Revision History Explanation
02/26/2018 R3 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. Effective 02/26/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
11/09/2017 R2

Under Article Text added the registered trademark symbol (®) to all of the antibacterial drugs and under  DALVANCE® added the verbiage “Enterococcus faecalis (vancomycin-susceptible isolates only)”.


12/22/2016 R1 Under Article Text Tedizolid (Sivextro) revised the verbiage in the first two sentences to read “Tedizolid (Sivextro) is an oxazolidinone-class antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms”.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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Public Versions
Updated On Effective Dates Status
01/31/2018 02/26/2018 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Tedizolid
  • Sivextro
  • Vibativ
  • Telavancin
  • Dalvance
  • Dalbavancin
  • Orbactiv
  • Oritavancin
  • Antibacterial