Author: GDIT, (800) 688-6696
Effective with date of service Jan. 6, 2020, the Medicaid and NC Health Choice programs cover imipenem, cilastatin and relebactam for injection, for intravenous use (Recarbrio™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified drugs.
Strength/Package Size(s): 1.25 grams for injection is supplied as sterile powder for constitution in a single-dose vial containing imipenem 500 mg (anhydrate equivalent), cilastatin 500 mg (free acid equivalent) and relebactam 250 mg (anhydrate equivalent).
Indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of the following infections caused by susceptible gram-negative bacteria:
- Complicated urinary tract infections, including pyelonephritis (cUTI)
- Complicated intra-abdominal infections (cIAI)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Recarbrio™ and other antibacterial drugs, Recarbrio™ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Recommended Dose: 1.25 grams (imipenem 500 mg, cilastatin 500 mg, relebactam 250 mg) by intravenous (IV) infusion over 30 minutes every 6 hours in patients 18 years of age and older with creatinine clearance (CLcr) 90 mL/min or greater. The recommended duration of treatment with Recarbrio™ is 4 days to 14 days.
See full prescribing information for further detail.
For Medicaid and NC Health Choice Billing
The ICD-10-CM diagnosis code(s) required for billing is/are: Complicated urinary tract infections (cUTI): N10 - Acute pyelonephritis; N11.0 - Nonobstructive reflux-associated chronic pyelonephritis; N11.1 - Chronic obstructive pyelonephritis; N11.8 - Other chronic tubulo-interstitial nephritis; N11.9 - Chronic tubulo-interstitial nephritis, unspecified; N12 - Tubulo-interstitial nephritis, not specified as acute or chronic; N13.6 - Pyonephrosis; N16 - Renal tubulo-interstitial disorders in diseases classified elsewhere; N30.00 - Acute cystitis without hematuria; N30.01 - Acute cystitis with hematuria; N30.20 - Other chronic cystitis without hematuria; N30.21 - Other chronic cystitis with hematuria; N30.80 - Other cystitis without hematuria; N30.81 - Other cystitis with hematuria; N30.90 - Cystitis, unspecified without hematuria; N30.91 - Cystitis, unspecified with hematuria; N34.1 - Nonspecific urethritis; N34.2 - Other urethritis; N39.0 - Urinary tract infection, site not specified
Complicated intra-abdominal infections (cIAI): K25.1 - Acute gastric ulcer with perforation; K25.2 - Acute gastric ulcer with both hemorrhage and perforation; K25.5 - Chronic or unspecified gastric ulcer with perforation; K25.6 - Chronic or unspecified gastric ulcer with both hemorrhage and perforation; K26.1 - Acute duodenal ulcer with perforation; K26.2 - Acute duodenal ulcer with both hemorrhage and perforation; K26.5 - Chronic or unspecified duodenal ulcer with perforation; K26.6 - Chronic or unspecified duodenal ulcer with both hemorrhage and perforation; K27.1 - Acute peptic ulcer, site unspecified, with perforation; K27.2 - Acute peptic ulcer, site unspecified, with both hemorrhage and perforation; K27.5 - Chronic or unspecified peptic ulcer, site unspecified, with perforation; K27.6 - Chronic or unspecified peptic ulcer, site unspecified, with both hemorrhage and perforation; K28.1 - Acute gastrojejunal ulcer with perforation; K28.2 - Acute gastrojejunal ulcer with both hemorrhage and perforation; K28.5 - Chronic or unspecified gastrojejunal ulcer with perforation; K28.6 - Chronic or unspecified gastrojejunal ulcer with both hemorrhage and perforation; K35.20 - Acute appendicitis with generalized peritonitis, without abscess; K35.21 - Acute appendicitis with generalized peritonitis, with abscess; K35.30 - Acute appendicitis with localized peritonitis, without perforation or gangrene; K35.31 - Acute appendicitis with localized peritonitis and gangrene, without perforation; K35.32 - Acute appendicitis with perforation and localized peritonitis, without abscess; K35.33 - Acute appendicitis with perforation and localized peritonitis, with abscess; K35.80 - Unspecified acute appendicitis; K35.890 - Other acute appendicitis without perforation or gangrene; K35.891- Other acute appendicitis without perforation, with gangrene; K36 - Other appendicitis; K37 - Unspecified appendicitis; K57.00 - Diverticulitis of small intestine with perforation and abscess without bleeding; K57.01 - Diverticulitis of small intestine with perforation and abscess with bleeding; K57.12 - Diverticulitis of small intestine without perforation or abscess without bleeding; K57.13 - Diverticulitis of small intestine without perforation or abscess with bleeding; K57.20 - Diverticulitis of large intestine with perforation and abscess without bleeding; K57.21 - Diverticulitis of large intestine with perforation and abscess with bleeding; K57.32 - Diverticulitis of large intestine without perforation or abscess without bleeding; K57.33 - Diverticulitis of large intestine without perforation or abscess with bleeding; K57.40 - Diverticulitis of both small and large intestine with perforation and abscess without bleeding; K57.41 - Diverticulitis of both small and large intestine with perforation and abscess with bleeding; K57.52 - Diverticulitis of both small and large intestine without perforation or abscess without bleeding; K57.53 - Diverticulitis of both small and large intestine without perforation or abscess with bleeding; K57.80 - Diverticulitis of intestine, part unspecified, with perforation and abscess without bleeding; K57.81 - Diverticulitis of intestine, part unspecified, with perforation and abscess with bleeding; K57.92 - Diverticulitis of intestine, part unspecified, without perforation or abscess without bleeding; K57.93 - Diverticulitis of intestine, part unspecified, without perforation or abscess with bleeding; K63.0 - Abscess of intestine; K63.1 - Perforation of intestine (nontraumatic); K65.0 - Generalized (acute) peritonitis; K65.1 - Peritoneal abscess; K65.2 - Spontaneous bacterial peritonitis; K65.3 - Choleperitonitis; K65.4 - Sclerosing mesenteritis; K65.8 - Other peritonitis; K65.9 - Peritonitis, unspecified; K68.11 - Postprocedural retroperitoneal abscess; K68.12 - Psoas muscle abscess; K68.19 - Other retroperitoneal abscess; K68.9 - Other disorders of retroperitoneum;
K80.00 - Calculus of gallbladder with acute cholecystitis without obstruction; K80.01 - Calculus of gallbladder with acute cholecystitis with obstruction; K80.10 - Calculus of gallbladder with chronic cholecystitis without obstruction; K80.11 - Calculus of gallbladder with chronic cholecystitis with obstruction; K80.12 - Calculus of gallbladder with acute and chronic cholecystitis without obstruction; K80.13 - Calculus of gallbladder with acute and chronic cholecystitis with obstruction; K80.18 - Calculus of gallbladder with other cholecystitis without obstruction; K80.19 - Calculus of gallbladder with other cholecystitis with obstruction; K80.40 -Calculus of bile duct with cholecystitis, unspecified, without obstruction; K80.41 - Calculus of bile duct with cholecystitis, unspecified, with obstruction; K80.42 - Calculus of bile duct with acute cholecystitis without obstruction; K80.43 - Calculus of bile duct with acute cholecystitis with obstruction; K80.44 - Calculus of bile duct with chronic cholecystitis without obstruction; K80.45 - Calculus of bile duct with chronic cholecystitis with obstruction; K80.46 - Calculus of bile duct with acute and chronic cholecystitis without obstruction; K80.47 - Calculus of bile duct with acute and chronic cholecystitis with obstruction; K80.60 - Calculus of gallbladder and bile duct with cholecystitis, unspecified, without obstruction; K80.61 - Calculus of gallbladder and bile duct with cholecystitis, unspecified, with obstruction; K80.62 - Calculus of gallbladder and bile duct with acute cholecystitis without obstruction; K80.63 - Calculus of gallbladder and bile duct with acute cholecystitis with obstruction; K80.64 - Calculus of gallbladder and bile duct with chronic cholecystitis without obstruction; K80.65 - Calculus of gallbladder and bile duct with chronic cholecystitis with obstruction; K80.66 - Calculus of gallbladder and bile duct with acute and chronic cholecystitis without obstruction; K80.67 - Calculus of gallbladder and bile duct with acute and chronic cholecystitis with obstruction; K81.0 - Acute cholecystitis; K81.1 - Chronic cholecystitis; K81.2 - Acute cholecystitis with chronic cholecystitis; K81.9 - Cholecystitis, unspecified
Additional codes, to identify infectious agent:
B96.1 - Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere; B96.20 - Unspecified Escherichia coli [E. coli] as the cause of diseases classified elsewhere; B96.21 - Shiga toxin-producing Escherichia coli [E. coli] (STEC) O157 as the cause of diseases classified elsewhere; B96.22 - Other specified Shiga toxin-producing Escherichia coli [E. coli] (STEC) as the cause of diseases classified elsewhere;
B96.23 - Unspecified Shiga toxin-producing Escherichia coli [E. coli] (STEC) as the cause of diseases classified elsewhere; B96.29 - Other Escherichia coli [E. coli] as the cause of diseases classified elsewhere; diseases classified elsewhere; A04.0 - Enteropathogenic Escherichia coli A04.1 - Enterotoxigenic Escherichia coli infection; A04.2 - Enteroinvasive Escherichia coli infection; A04.3 - Enterohemorrhagic Escherichia coli infection; A04.4 - Other intestinal Escherichia coli infections; A04.8 - Other specified bacterial intestinal infections; A04.9 - Bacterial intestinal infection, unspecified; B96.5 - Pseudomonas (aeruginosa) (mallei) (pseudomallei) as the cause of diseases classified elsewhere; B96.6 - Bacteroides fragilis [B. fragilis] as the cause of diseases classified elsewhere
- Providers must bill with HCPCS code: J3490 - Unclassified drugs.
- One Medicaid and NC Health Choice unit of coverage is: 1.25 g (1 vial).
- The maximum reimbursement rate per unit is: $288.90.
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs is/are: 00006-3856-01, 00006-3856-02
- The NDC units should be reported as “UN1.”
- For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update.
- For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website.
- Providers shall bill their usual and customary charge for non-340B drugs.
- PADP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the “UD” modifier on the drug detail.
- The fee schedule for the PADP is available on Medicaid's PADP web page.