DIFICID®

(fidaxomicin) tablets, for oral use

Professional Resources

Possible relevant C. difficile ICD-10 codes

Patients with Clostridium difficile–associated diarrhea may experience repeat episodes, and the risk of a recurrence increases with each episode.1 Twenty-five percent to 30% of patients develop recurrence within days or weeks of an initial infection.2 Recurrence is associated with greater morbidity, and practice guidelines provide distinct recommendations for the management of recurrence.2 

These were some of the factors considered when the CDC recommended, and CMS adopted, these codes.3 

The codes, now available for use, are4:

Possible relevant ICD-10 codes for DIFICID® (fidaxomicin)

Code Diagnosis
A04.71 Enterocolitis due to Clostridium difficile, recurrent
A04.72 Enterocolitis due to Clostridium difficile, not specified as recurrent

Providers are now able to more easily identify patients who have had previous CDAD episodes, and can thus aid in decision-making about appropriate treatment options.

The above codes may be potentially relevant when billing for DIFICID and its administration. Consult the relevant manual and/or other guidelines for a description of each code to determine the appropriateness of its use and for information on additional codes. Diagnosis codes should be selected only by a health care professional. Please consult with the applicable payer to understand the payer’s specific billing requirements. This information is subject to change.

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. Merck and its agents make no warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for your particular use given the frequent changes in public and private payer billing. The use of this information does not guarantee payment or that any payment received will cover your costs.

Definitions

CDAD = Clostridium difficile–associated diarrhea

CDC = Centers for Disease Control and Prevention

CMS = Centers for Medicare and Medicaid Services

References

1. Cohen SH, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010;31(5):431–455. doi:10.1086/651706.

2. Department of Health and Human Services. Centers for Medicare and Medicaid Services. Document CMS-1677-F. Published in the Federal Register August 14, 2017. https://federalregister.gov/d/2017-16434. Accessed September 29, 2017.

3. ICD-10 code lookup. Centers for Medicare and Medicaid Services website. https://www.cms.gov/medicare-coverage-database/staticpages/icd-10-codelookup.aspx?KeyWord=clostridium%20difficile&bc=AAAAAAAAAAAQAA%3d%3d&. Accessed September 29, 2017.

4. Clostridium difficile. ICD-10 coordination and maintenance committee meeting. Centers for Disease Control and Prevention. March 9–10, 2016.

Indication

DIFICID is a macrolide antibacterial drug indicated in adults (≥18 years of age) for treatment of Clostridium difficile–associated diarrhea (CDAD). 

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by C difficile.

Selected Safety Information

  • DIFICID is contraindicated in patients with hypersensitivity to fidaxomicin.
  • DIFICID should not be used for systemic infections.
  • Acute hypersensitivity reactions, including dyspnea, rash pruritus, and angioedema of the mouth, throat, and face have been reported with fidaxomicin. If a severe hypersensitivity reaction occurs, DIFICID should be discontinued and appropriate therapy should be instituted.
  • Only use DIFICID for infection proven or strongly suspected to be caused by C difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C difficile infection is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.
  • The most common adverse reactions reported in clinical trials are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%).
  • Among patients receiving DIFICID, 33 (5.9%) withdrew from trials as a result of adverse reactions. Vomiting was the primary adverse reaction leading to discontinuation of dosing (incidence of 0.5% for both DIFICID and vancomycin patients).
  • The safety and effectiveness of DIFICID in patients <18 years of age have not been established.
  • The recommended dose of DIFICID is one 200 mg tablet orally twice daily for 10 days, with or without food.
  • No dose adjustment is recommended for patients ≥65 years of age.
  • No dose adjustment is recommended for patients with renal impairment.
  • No dosage adjustments are recommended when co-administering fidaxomicin with substrates of P-gp or CYP enzymes.
  • The impact of hepatic impairment on the pharmacokinetics of fidaxomicin has not been evaluated; however, because fidaxomicin and its active metabolite (OP-1118) do not appear to undergo significant hepatic metabolism, elimination of fidaxomicin and OP-1118 is not expected to be significantly affected by hepatic impairment.
Before prescribing DIFICID® (fidaxomicin), please read the Prescribing Information.
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