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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