TREATMENT INFORMATION

We provide screened, frozen, ready-to-use human fecal microbiota preparations for the treatment of recurrent Clostridium difficile infections not responding to standard therapies. Here, you'll find information about our treatment formats and pricing, as well storage, thawing, and coding.

Our Clinical Outreach Team is available 9 AM - 5 PM EST, Monday - Friday to answer and questions you might have. Write to us at info@openbiome.org or call 617-575-2201, option 3.

Treatment Formats

Our microbiota preparations come in three formats, each designed to maximize the safety and efficacy of the modality used to deliver the material.

OpenBiome has collaborated with Finch Therapeutics to develop CP101, a freeze-dried oral FMT capsule, to expand and ensure long-term access to FMT for recurrent C. diff. Trial sites around the U.S. and Canada are now enrolling patients. Learn more about participating in the trial at prism3trial.com.



FMT LOWER DELIVERY

For colonoscopy, sigmoidoscopy, or enema

Item: FMP250
Price: $485 per dose (1 bottle)
Viability: 6 months at -20°C; 12 months at -80°C



FMT UPPER DELIVERY

For nasoenteric/gastric tube or EGD

Item: FMP30
Price: $485 per dose (1 bottle)
Viability: 6 months at -20°C; 12 months at -80°C




FMT CAPSULE DE

For oral administration
Orders of capsules are capped at three units

Item: FMPCapDE
Price: $635 per dose (1 bottle = 30 capsules)
Viability: 6 months at -20°C or colder
*Includes 2 inert test capsules to assess patient's swallowing abilities
Physician orientation required before first order



    • Treatments must remain frozen: Our treatment units ship overnight via UPS and are packaged on dry ice. Each package includes a temperature indicator that verifies that the material remained at a suitable temperature throughout transit. Upon arrival, material should immediately be transferred to a standard -20°C (-4°F) freezer (or colder).

      Freezer specifications: Our microbiota preparations must be stored at no greater than -20°C, with transient fluctuations of +5°C acceptable. In certain circumstances, we may be able to provide material shortly enough before an FMT procedure to avoid local storage, but it is far more reliable to maintain a small local inventory. OpenBiome does not guarantee rush delivery nor delivery on a specified date.

      Expiration: The shelf life of our products varies by temperature (see Storage Controls & Material Specifications or Treatment Formats, above). Storing material onsite ensures availability in immediate need, and saves on shipping costs.

      Where to store material: There is no official guidance dictating where OpenBiome material must be stored. Among our partners, material is most often handled by Endoscopy, followed by Pharmacy, Laboratory, and Microbiology. Storage decisions are usually dictated by availability of space and internal protocols and regulations. We are happy to work with whichever department your facility chooses to manage the material.

      Storage controls & material specifications: Our material is packaged in PET bottles with tamper-evident seals. Sterile microbiological technique should be followed when handling material to avoid contamination. Please see our Storage Controls & Material Specifications document for more detail on the size of our products and thorough handling instructions.

      Material disposal: Any material that expires or for any other reason cannot be used should be destroyed locally as hazardous waste material.

    • Upper and lower delivery preparations: We recommend that units be thawed using a 30°C warm water bath. Alternative methods include thawing at room temperature and thawing in a refrigerator. Thaw times will vary by product. Once thawed, a treatment can sit at room temperature for up to 4 hours, or in a refrigerator for up to 8 hours. For more, see our Storage Controls & Material Specifications document.

      Capsules: Capsules should not be thawed. They should remain frozen until ready for administration. If capsules are removed from frozen storage but not administered to a patient, they must be returned to frozen storage within 10 minutes or discarded. For more information, please see the FMT Capsule DE Primer.

      Note: Once thawed, treatments should not be refrozen. Freeze-thaw cycles adversely impact the viability of the microbial communities in the preparation.

    • Who we bill: OpenBiome bills the medical facility that provides the treatment. We do not accept direct payments from patients. Please see the Invoicing section on the Place an Order page for more information about remitting payment.

      How hospitals pay: Although each hospital is unique, there are a few common approaches. Some hospitals use their facility fee to pay for OpenBiome material. Other pass the cost directly through to insurance providers that reimburse FMT (e.g., Athena). Some have patients pay out-of-pocket, still other hospitals have grants or gifts to pay for FMT programs. Regardless of the approach taken, our model significantly reduces the cost of providing FMT.

      CPT codes: There is not currently a code to specifically describe FMT. The appropriate code varies by route of administration. According to the AGA's coding guidance and the CPT Handbook, FMT instilled by enema or oro-/naso-gastric tube should be reported using unlisted code 44799. For FMT by other modalities (e.g., colonoscopy), use the CPT code appropriate to that procedure.

      Please note that CPT codes 44705 and HCPCS code G4055 should not be reported when FMT is performed using material from a stool bank, as these codes describe the work done by the treating physician in preparing donor stool for use. For more, please reference the OpenBiome Billing Guide.

      Patient assistance: As a 501(c)(3) nonprofit, we work hard to keep our treatments affordable. However, if you have a patient for whom the cost of our material presents a significant financial barrier, we may be able to offer help through the OpenBiome Patient Assistance Program, made possible through a generous grant from the Anna-Maria & Stephen M. Kellen Foundation. For more on this program, please write to info@openbiome.org.