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The OpenBiome Billing Guide A Guide to Physician and Hospital Billing for Using OpenBiome Fecal Microbiota Preparations We have developed this guide to support your efforts through the reimbursement process. If you require additional support, our Clinical Outreach Team is available Monday – Friday, 9:00 AM to 5:00 PM ET, by phone at 617-575-2201, option 3, or by email at [email protected]. Documentation, Coding, & Reimbursement It is the provider’s responsibility to thoroughly document the work done in providing fecal microbiota transplant (FMT). Detailed documentation of indication and of the therapy’s administration (including the unit number of the preparation) increases the likelihood that insurers will reimburse claims appropriately. The following codes represent possible options only. It is up to the provider or facility to submit the most appropriate codes and charges. Diagnosis Coding It is always the provider’s responsibility to verify the specificity of a diagnosis code. Use of OpenBiome material is permitted by the FDA1 for clinical treatment of recurrent Clostridium difficile infections (CDI) not responsive to standard therapies. The diagnosis codes in Table 1 are often used to report CDI. Table 1 – Common diagnosis codes used to report CDI ICD-9-CM Code 008.45 Code Descriptor Intestinal infection due to Clostridium difficile ICD-10-CM Code A04.7 Code Descriptor Enterocolitis due to Clostridium difficile Evaluation and Management (E/M) Coding The evaluation of patients diagnosed with CDI pre- and post-FMT may be covered by several CPT codes (e.g., office visits). Please reference your CPT code book or coding specialist when choosing the most appropriate codes for these encounters. 1 As per the prevailing Guidance for Industry published July 2013: http://1.usa.gov/1Mt0JCz Rev. June 2016 www.openbiome.org 200 Inner Belt Road Somerville, MA 02143 Phone/Fax: 617-575-2201 [email protected] Procedure Coding CPT codes as they currently exist very narrowly cover FMT. When using material obtained from OpenBiome, CPT code 44705 and HCPCS code G0455 should not be reported. Both describe work done by the treating provider in preparing stool material for transplant, and thus are not applicable when material is obtained from a stool bank. Table 2 lists CPT codes commonly used by our clinical partners to report the route of administration. Table 2 – Common CPT codes used to report administration of FMT CPT Code 43752 44360 45330 45378 Descriptor Naso- or oro-gastric tube placement, requiring physician’s skill and fluoroscopic guidance (includes fluoroscopy, image documentation and report) Small intestinal endoscopy, enteroscopy beyond second portion of duodenum, not including ileum; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure) Sigmoidoscopy, flexible; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure) Colonoscopy, flexible; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure) Reimbursement* $39.74 $182.59 $93.58 $263.57 In addition to these administration routes, providers may also bill using code 44799 or code 45399 as deemed appropriate (Table 3). If using one of these codes, it is especially necessary to provide thorough documentation of the indication for FMT as well as the work done in carrying out the procedure. On Medicare form CMS 1500, it is useful to include code G0455 in Box 19. Table 3 – CPT codes used for unlisted procedures CPT Code 44799 45399 Descriptor Unlisted procedure, small intestine Unlisted procedure, colon Reimbursement* $365.09 No data. *National average Medicare reimbursements; no modifiers. Rev. June 2016 2 Coding for Fecal Microbiota Preparations (Material) No code currently exists to cover material obtained from a stool bank. Providers performing FMT in the office setting will be responsible for the cost of the fecal microbiota preparation. Amongst our clinical network, some partners choose bear to the cost of material while others bill patients directly. Alternatively, you may consider using HCPCS code J3590 (Table 4) for the cost of material, though we are unable to comment on the success of using this code. Be sure to list the price of the unit in Box 19 of CMS 1500, as well as its concentration. Please note that OpenBiome preparations do not have NDC numbers. Table 4 – HCPCS level II code providers may attempt to use to bill for material HCPS Level II Code J3590 Descriptor Unclassified biologics Facility Billing FMT done in the facility setting is reported using HCPCS level I codes (i.e., CPT codes) as described in Table 2. For inpatient settings, ambulatory surgical centers, and hospital outpatient settings, the facility should report the revenue codes and modifiers appropriate to the patient’s stay/procedure. The fecal microbiota preparations provided by OpenBiome are designated as an investigational biologic drug by the FDA and regulated under enforcement discretion. As such, material used in a facility setting should be reported using Revenue Code 0256 (Table 5). Some of our partner facilities bill their patients directly for the cost of material, while still others internalize the cost given the long-term savings (such as fewer hospital readmissions and mitigated risk of C. diff. outbreaks) afforded by the procedure. Table 5 – Revenue code appropriate for use with OpenBiome material Revenue Code 0256 Descriptor Experimental new drug Disclaimer The information contained in this document is provided for informational purposes only and represents no statement, promise, or guarantee by OpenBiome concerning levels of reimbursement, payment, or charge. Similarly, all CPT, ICD-9-CM, ICD-10-CM, and HCPCS codes are supplied for informational purposes only and represent no statement, promise, or guarantee by OpenBiome that these will be appropriate or that Rev. June 2016 3 reimbursement will be made. It is not intended to increase or maximize reimbursement by any payor. While we have made an effort to provide information that is current at the time of its issue, the information may not be as current or comprehensive when you view it. We strongly recommend you consult your counsel, reimbursement specialist, or payor organization with regard to reimbursement policies. CPT codes and descriptions are copyright 2015 the American Medical Association. ICD-9 and ICD-10 codes and descriptions are copyright 2015 the World Health Organization. HCPCS codes and descriptions are copyright 2015 the Centers for Medicare and Medicaid Services. Rev. June 2016 4