Transplantation of Small Bowel, Small Bowel-Liver Or Multivisceral Organs

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Medical Policy

Transplantation of Small Bowel, Small Bowel-Liver or Multivisceral Organs

Policy Number: OCA 3.26 Version Number: 16 Version Effective Date: 06/07/17

Product Applicability All Plan+ Products

Well Sense Health Plan Boston Medical Center HealthNet Plan New Hampshire Medicaid MassHealth NH Health Protection Program Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options ◊

Notes: + Disclaimer and audit information is located at the end of this document. ◊ The guidelines included in this Plan policy are applicable to members enrolled in Senior Care Options only if there are no criteria established for the specified service in a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request. Review the member’s product-specific benefit documents at www.SeniorsGetMore.org to determine coverage guidelines for Senior Care Options.

Policy Summary The Plan considers small bowel transplantation, small bowel-liver transplantation, or transplantation of multivisceral organs for the treatment of irreversible intestinal failure for adults and children (including infants) to be medically necessary when Plan medical criteria are met. All transplant-related consults, evaluations, procedures, and post-transplant follow-up services should be managed within the Plan’s provider network or at the most appropriate preferred transplant facility, depending upon the type of transplant. Prior authorization is required for all transplantation services.

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

+ Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan. 1 of 27

It will be determined during the Plan’s prior authorization process if the specific transplant service is considered medically necessary for the requested indication within the Plan’s provider network, as appropriate. Review the Plan policy, Medically Necessary (policy number OCA 3.14), for the product- specific definitions of medically necessary treatment. See the Plan medical policy, Transplantation of Pancreas or Pancreas-Kidney (policy number OCA 3.25), rather than this policy for medical necessity criteria for pancreas transplants that do NOT include transplantation of multivisceral organs or for combined kidney-pancreas transplants. When there is no Plan medical policy for the requested type of transplantation (e.g., transplantation of the liver without small bowel transplant), the Plan uses InterQual® criteria to determine medical necessity for the transplantation services, or the Plan conducts an individual evaluation of the member’s medical condition based on the Plan’s Clinical Criteria policy (policy number OCA 3.201) when InterQual® criteria are not established for the requested type of transplantation.

The Plan member must meet the eligibility criteria from the transplanting institution. The eligibility criteria of the transplanting institution must follow the applicable United Network for Organ Sharing (UNOS) guidelines. The hospital in which the organ transplants are performed must be a member of the Organ Procurement and Transplantation Network (OPTN) in accordance with the Public Health Service Act, comply with applicable OPTN organ allocation and procurement guidelines, and follow the Centers for Medicare & Medicaid Services (CMS) applicable conditions of participation for the specified organ to be transplanted (including but not limited to the following Code of Federal Regulations: 42 CFR Parts 405, 482, 488, and 498). The transplant program (including affiliated transplant facility, transplant surgeons, transplant physicians, and staff) must follow the designated UNOS/OPTN transplant program criteria for the applicable transplant service and comply with all applicable UNOS/OPTN professional standards. Senior Care Options members will have access to transplant services according all applicable CMS guidelines, including but not limited to the provisions specified in the Medicare Managed Care Manual, Chapter 4 – Benefits and Beneficiary Protections, 10.11 Transplant Services.

Description of Item or Service Small Bowel Transplant: A small bowel transplant usually involves the removal of the small intestine from a deceased donor, removal of the recipient's small intestine, and replacement with the donor's intestine. A cadaveric small bowel transplant is always considered before transplantation from a living donor. Living donor small bowel transplantation is an alternative to cadaveric small bowel transplantation for the treatment of patients with irreversible intestinal failure who cannot tolerate total parenteral nutrition (TPN) and is considered when a cadaver donor is unavailable in a timely manner. If a living donor is used, a segment of the donor's small intestine is transplanted. A small bowel transplant is typically performed on individuals with short bowel syndrome, but the procedure is appropriate for certain other conditions.

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

Small Bowel-Liver Transplant: A small bowel-liver transplant involves the removal of the small intestine and liver from a deceased donor, removal of the recipient’s small intestine and liver, and replacement with the donor’s intestine and liver. A small bowel-liver transplant is indicated for individuals with intestinal failure and liver failure.

Multivisceral Transplant: Transplantation of the small bowel and liver with one (1) or more of the following organs from the digestive system: stomach, duodenum, jejunum, ileum, pancreas, and/or colon. A multivisceral transplant is indicated when anatomic or other medical problems preclude a small bowel transplant. Multivisceral transplantation is considered when individuals have irreversible failure of three (3) or more abdominal organs including the small bowel. The most common indications for multivisceral transplantation are total occlusion of the splanchnic circulation, extensive gastrointestinal polyposis, hollow visceral myopathy or neuropathy, and/or some abdominal malignancies.

Medical Policy Statement See the Plan medical policy, Transplantation of Pancreas or Pancreas-Kidney (policy number OCA 3.25), rather than this policy for medical necessity criteria for pancreas transplants that do NOT include transplantation of multivisceral organs or for combined kidney-pancreas transplants. The Plan considers small bowel transplantation or multivisceral transplantation to be medically necessary when medical record documentation supports that ALL of the following applicable Plan criteria have been met, as specified below in item A (Initial Transplantation and Retransplantation Criteria for Adult and Pediatric Members), item B (Procedure-Specific Criteria for Adult and Pediatric Members), and item C (Age-Specific Criteria):

A. Initial Transplantation and Retransplantation Criteria for Adult and Pediatric Members: **

See applicable criteria below, EITHER item 1 for criteria for an initial transplantation or item 2 for criteria for retransplantation.

1. Initial Transplantation Criteria:

ALL of the following criteria must be met for each adult member or pediatric member who is a candidate for an initial transplantation, as specified below in items a through d:

a. Member has total irreversible intestinal failure characterized by BOTH of the following conditions, as specified below in items (1) and (2):

(1) Loss of absorption; AND

(2) The inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance; AND

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

b. Transplantation is for any ONE (1) of the following indications, as specified below as item (1), item (2), or item (3):

(1) Treatment of malignancy (when the transplant surgeon has determined that transplantation is the most appropriate treatment for the member’s condition and treatment is consistent with the guidelines specified in the Limitations section of this policy); OR

(2) Intra-abdominal non-metastasizing tumor(s) that is growing locally and is progressively obstructing the bowel where removal of the tumor(s) requires resecting the entire intestine and replacing it with a transplanted intestine (when the transplant surgeon has determined that transplantation is the most appropriate treatment for the member’s medical condition and treatment is consistent with the guidelines specified in the Limitations section of this policy); OR

(3) Failure of total parenteral nutrition (TPN), including home parenteral nutrition, resulting from any ONE (1) of the following criteria, as specified below as items (a) through (e):

(a) Sepsis with at least ONE (1) of the following, as specified below in item (i) or item (ii):

(i) Severe sepsis as evidenced by the development of two (2) or more episodes of systemic sepsis per year secondary to line sepsis, requiring hospitalization; OR

(ii) A single episode of line-related fungemia, septic shock, and/or acute respiratory distress syndrome (ARDS); OR

(b) Frequent episodes of severe dehydration (as defined by the treating provider) despite intravenous fluid supplementation in addition to TPN (since frequent episodes of dehydration are detrimental to all body organs, especially the kidney and the central nervous system, with the development of multiple kidney stones, renal failure, and permanent brain damage); OR

(c) Impending or overt liver failure due to TPN-induced liver injury with at least ONE (1) of the following clinical manifestations, as specified below in items (i) through (vii):

(i) Coagulopathy; OR

(ii) Elevated serum bilirubin and/or liver enzymes; OR

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

(iii) Gastroesophageal varices; OR

(iv) Hepatic fibrosis or cirrhosis; OR

(v) Splenomegaly; OR

(vi) Stomal bleeding; OR

(vii) Thrombocytopenia; OR

(d) Thrombosis of TWO (2) or more of the major central veins including jugular, subclavian, or femoral veins, as a life-threatening complication and failure of TPN therapy; OR

(e) Loss of vascular access; AND

c. All individual eligibility criteria of the transplanting institution are met; AND

d. The donor meets ONE (1) of the following guidelines, as specified below in item (1) or item (2):

(1) A cadaver donor will be used for the small bowel, small bowel-liver, or multivisceral transplant; OR

(2) A living donor will be used rather than a cadaver donor for a small bowel transplant or small bowel-liver transplant when the transplant team has determined that the member is a suitable candidate for a living donor transplant and ONE (1) of the following criteria are met, as specified below in item (a) or item (b):

(a) A cadaver donor is unavailable; OR

(b) Member is deteriorating clinically to the point of transplant ineligibility while waiting for cadaveric organ donation; OR

2. Retransplantation Criteria:

Retransplantation is covered when BOTH of the following criteria are met for an adult or pediatric member who is a candidate for retransplantation, as specified below in item a. and item b:

a. Criteria are met for the initial transplant (as specified in item A1 above, Initial Transplantation Criteria); AND

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

b. The member has at least ONE (1) of the following indications, as specified below in item (1), item (2), or item (3):

(1) Graft failure of an initial small bowel, small bowel-liver, or multivisceral transplant due to ONE (1) of the following, as specified below in item (a) or item (b):

(a) Technical reason, excluding serious reportable event and/or provider- preventable condition; † OR

†Note: See Plan policy, Reimbursement Guidelines – Health Care Acquired Conditions, Provider Preventable Conditions and Serious Reportable Events, policy number 4.610 for BMC HealthNet Plan products and policy number WS 4.29 for Well Sense Health Plan products, for definitions of serious reportable events and provider-preventable conditions

(b) Hyperacute rejection (see Definitions section); OR

(2) Chronic rejection (see Definitions section); OR

(3) Recurrent disease; AND

B. Procedure-Specific Criteria for Adult and Pediatric Members: **

The transplant surgeon has determined that transplantation is the most appropriate treatment for the member’s medical condition and ONE (1) of the following categories of applicable, procedure- specific criteria is met, as specified below in items 1 through 3:

1. Isolated Small Bowel Transplantation:

There are no procedure-specific criteria; OR

2. Small Bowel-Liver Transplantation:

Member meets at least ONE (1) of the following criteria, as specified below in items a through d:

a. Member has intestinal failure with end-stage hepatic disease; OR

b. Member has intestinal failure from a hypercoagulable state associated with enzyme deficiencies that can be corrected by a liver graft; OR

c. Member has mesenteric venous thrombosis; OR Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

d. The member has documented, unreconstructable portomesenteric venous systems; OR

3. Multivisceral Transplantation:

Member meets ALL of the following criteria, as specified below in items a through c:

a. The member requires transplantation of the small bowel; AND

b. The member has concurrent liver failure requiring a liver transplant; AND

c. The member meets at least ONE (1) of the following criteria, as specified below item (1) or item (2):

(1) The member has documented, unreconstructable portomesenteric venous systems; OR

(2) The member requires ONE (1) or more abdominal visceral organs (i.e., stomach, duodenum, jejunum, ileum, pancreas,∞ and/or colon) to be transplanted (as determined by the treating transplant surgeon) due at least ONE (1) of the following, as specified below in items (a) through (c):

(a) Concomitant organ failure; OR

(b) Anatomical abnormalities; OR

(c) Pancreas∞ transplant for a member with a history of diabetes and pancreatic exocrine insufficiency (as determined by the transplant surgeon); AND

∞Note: See the Plan medical policy, Transplantation of Pancreas or Pancreas- Kidney (policy number OCA 3.25), rather than this policy for medical necessity criteria for pancreas transplants that do NOT include transplantation of multivisceral organs or for combined kidney-pancreas transplants.

C. Age-Specific Criteria: **

See applicable, age-specific criteria listed below, EITHER item 1 for an adult member (age 18 or older on the date of service) or item 2 for a pediatric member (age less than 18 years old on the date of service).

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

1. Age-Specific Criteria for Adult Members (Age 18 or Older on the Date of Service):

The adult member is diagnosed with at least ONE (1) of the following conditions, as specified below in items a through e:

a. Granulomatous disease, including but not limited to Crohn’s disease; OR

b. Intestinal vascular insufficiency, including but not limited to ONE (1) of the following conditions, as specified below in items (1) through (3):

(1) Budd-Chiari syndrome; OR

(2) Mesenteric artery insufficiency; OR

(3) Mesenteric venous thrombosis (due to hypercoagulable state, protein S or C deficiency and antithrombin III deficiency); OR

c. Neoplasm, including but not limited to ONE (1) of the following, as specified below in items (1) through (3):

(1) Familial adenomatous polyposis (FAP); OR

(2) Gardner’s syndrome; OR

(3) Diffuse mesenteric fibroadenomatosis; OR

d. Trauma, including but not limited to ONE (1) of the following, as specified below in items (1) and (2):

(1) Gunshot wound; OR

(2) Motor vehicle accident; OR

e. Other conditions including ONE (1) of the following, as specified below in items (1) through (4):

(1) Massive resection secondary to tumor; OR

(2) Pseudo-obstruction; OR

(3) Radiation enteritis; OR

(4) Volvulus; OR Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

2. Age-Specific Criteria for Pediatric Members (Under Age 18 on the Date of Service):

The pediatric member is diagnosed with at least ONE (1) of the following conditions, as specified below in items a through c:

a. Congenital condition, including any ONE (1) of the following specified below in items (1) through (4):

(1) Atresia or stenosis; OR

(2) Gastroschisis; OR

(3) Dysmotility disorder, including any ONE (1) of the following conditions, as specified below in items (a) through (c):

(a) Hirschsprung’s disease; OR

(b) Megacystis microcolon; OR

(4) Mucosal cell disease, including any ONE (1) of the following conditions, as specified below in item (a) or item (b):

(a) Microvillus inclusion disease; OR

(b) Tufting enteropathy; OR

b. Perinatal complication, including any ONE (1) of the following conditions, as specified below in item (1) or item (2):

(1) Necrotizing enterocolitis (NEC); OR

(2) Volvulus; OR

c. Other condition, including any ONE (1) of the following specified below in items (1) through (4):

(1) Short gut syndrome; OR

(2) Status post intestinal transplant; OR

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

(3) Trauma; OR

(4) Chronic intestinal pseudo-obstruction

**Note: ALL applicable criteria must be met for an initial transplantation or retransplantation (as specified above in item A), ALL applicable procedure-specific criteria must be met (as specified above in item B) , and ALL applicable age-specific criteria must be met (as specified above item C) for the Plan to consider the transplant service medically necessary.

Limitations

1. Plan Medical Director review is required for a member older than age 65 on the date of service.

2. Absence of TPN Failure: A small bowel transplant, small bowel-liver transplant, or multivisceral transplant in an adult or pediatric member is considered NOT medically necessary for those who have NOT failed total parenteral nutrition unless the intestinal transplant is considered medically necessary to treat a malignancy or for another indication, as determined by the transplantation surgeon (e.g., dysmotility disorder, genetic intestinal disorder of the mucosal cells, disease with a high potential for malignant degeneration, neoplastic tumors of the gastrointestinal tract and pancreas that are limited to the abdominal cavity, radiation-induced bowel injury, and/or unreconstructable portomesenteric thrombosis with associated liver failure).

2. Xenotransplantation: Small bowel, small bowel-liver or multivisceral xenotransplantation (e.g., porcine xenografts) is considered experimental and investigational for any indication. See the Plan’s policy, Experimental and Investigational Treatment, policy number OCA 3.12, for the product-specific definitions of experimental or investigational treatment.

3. Contraindications: Many factors can affect the outcome of organ transplantation. Fairly rigid selection criteria are required to obtain optimal results for each patient. Contraindications include but are not limited to at least ONE (1) of the following, as specified below in items a through o:

a. Acute or chronic infection that is not adequately treated; OR

b. Active substance abuse within the last six (6) months; OR

c. Active systemic illness that is likely to negatively affect the outcome of the transplant; OR

d. AIDS (diagnosis based on CDC definition of CD4 count, 200cells/ mm3) unless ALL of the following are noted in the member’s medical record, as specified below in items (1) through (4): Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

(1) CD4 count greater than 200cells/ mm3 for more than 6 months; AND

(2) HIV-1 RNA undetectable; AND

(3) On stable anti-retroviral therapy for more than three (3) months; AND

(4) No other complications from AIDS (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioide-mycosis, resistant fungal infections, Kaposi's sarcoma or other neoplasm); OR

e. Cerebral edema; OR

f. Congenital immune deficiency syndrome(s); OR

g. Demonstrated patient noncompliance which would place the organ at risk by not adhering to medical recommendations; OR

h. Aggressive malignancy known and active (including metastatic cancer, other than non- melanomatous skin cancer) when the malignancy is not an indication for small bowel, small bowel-liver, or multivisceral transplantation; OR

i. Aggressive malignancy recently treated with a high or moderate risk of recurrence as assessed by the transplant team, when the malignancy is not an indication for small bowel, small bowel-liver, or multivisceral transplantation; OR

j. Multisystem organ failure including cardiac, pulmonary, and/or neurologic; OR

(Note: Since kidney transplant can be included as part of a multivisceral transplant, renal failure itself is not a contraindication)

k. Tissue incompatibility between donor and recipient as determined by a positive preoperative crossmatch; OR

l. Severe physical debilitation not responsive to previous intensive nutritional support; OR

m. Severe irresolvable cardiac, respiratory, and/or neurologic complications that would affect the outcome of the transplant; OR

n. Uncontrollable sepsis; OR

o. Morbid obesity with a BMI > 40; these types of transplants require intra-abdominal surgery, and post-transplantation wound healing is affected by an elevated BMI (i.e., relative Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

contraindication)

See the Plan medical policy, Transplantation of Pancreas or Pancreas-Kidney (policy number OCA 3.25), rather than this policy for medical necessity criteria for pancreas transplants that do NOT include transplantation of multivisceral organs or for combined kidney-pancreas transplants.

Definitions Intestinal Failure: The loss of absorptive capacity of the small bowel secondary to severe primary gastrointestinal disease or surgically induced short bowel syndrome. Intestinal failure results from obstruction, dysmotility, surgical resection, congenital defect, or disease-associated loss of absorption and is characterized by the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance.

Mesenteric Venous Thrombosis: Thrombus or a blood clot that blocks blood flow in the mesenteric venous system. There are two (2) main mesenteric veins that drain the small and large intestines. The inferior mesenteric vein drains the left colon into the splenic vein, which later joins the superior mesenteric vein to form the portal vein to the liver. The superior mesenteric vein drains the remaining to the colon and the small bowel. This condition stops the venous blood return of the intestines and if acute, can result in damage to the intestine. There are several diseases that can lead to mesenteric venous thrombosis. Many of the diseases cause swelling (inflammation) of the tissues surrounding the veins, and include appendicitis, cancer, diverticulitis, and/or pancreatitis. Liver disease with cirrhosis can cause venous stasis with resulting thrombosis.

Short Bowel Syndrome (Short Gut Syndrome): A condition in which the absorbing surface of the small intestine is inadequate due to extensive disease or surgical removal of a large portion of small intestine. Short-bowel syndrome results from surgical resection, congenital defect, or disease- associated loss of absorption and is characterized by the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balances when on a conventionally accepted, normal diet. Etiologies of short bowel syndrome include volvulus, atresias, necrotizing enterocolitis, Crohn’s disease, gastroschisis, thrombosis of the superior mesenteric artery, desmoid tumors, and/or trauma. Patients with short bowel syndrome are typically unable to obtain adequate nutrition from enteral feeding and become dependent upon total parenteral nutrition (TPN).

Transplant Rejection: A process in which a transplant recipient's immune system attacks the transplanted organ or tissue. There are three (3) clinicopathologic stages of rejection:

1. Hyperacute Rejection: A recipient’s immune reaction that occurs within a few minutes after the transplant when the antigens are completely unmatched, resulting in organ failure within the first hours after transplantation. The tissue must be removed right away so the recipient does not die.

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

2. Acute Rejection: A recipient’s immune reaction that occurs any time from the first week after the transplant (during which the immune response increases in intensity) and generally up to 60 to 90 days after organ transplantation. It may be Grade I (mild), Grade II (moderate) or Grade III (severe). All recipients have some amount of acute rejection.

3. Chronic Rejection: A recipient’s immune reaction that occurs more than 60 days after transplantation and can take place over many years. This is the body's constant immune response against the new organ that slowly damages the transplanted tissues or organ.

Xenotransplantation: According to the U.S. Public Health Service, xenotransplantation is defined as any procedure that involves the transplantation, implantation, or infusion into a human recipient of either of the following, as specified below in item 1 or item 2:

1. Live cells, tissues, or organs from a non-human animal source; or

2. Human body fluids, cells, tissues or organs that have had ex vivo contact with live non-human animal cells, tissues, or organs. (See this policy’s Limitations section.)

Applicable Coding The Plan uses and adopts up-to-date Current Procedural Terminology (CPT) codes from the American Medical Association (AMA), International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10) diagnosis codes developed by the World Health Organization and adapted in the United Stated by the National Center for Health Statistics (NCHS) of the Centers for Disease Control under the U.S. Department of Health and Human Services, and the Health Care Common Procedure Coding System (HCPCS) established and maintained by the Centers for Medicare & Medicaid Services (CMS). Because the AMA, NCHS, and CMS may update codes more frequently or at different intervals than Plan policy updates, the list of applicable codes included in this Plan policy is for informational purposes only, may not be all inclusive, and is subject to change without prior notification. Whether a code is listed in the Applicable Coding section of this Plan policy does not constitute or imply member coverage or provider reimbursement. Providers are responsible for reporting all services using the most up-to-date industry-standard procedure and diagnosis codes as published by the AMA, NCHS, and CMS at the time of the service.

Providers are responsible for obtaining prior authorization for the services specified in the Medical Policy Statement section and Limitation section of this Plan policy, even if an applicable code appropriately describing the service that is the subject of this Plan policy is not included in the Applicable Coding section of this Plan policy. Coverage for services is subject to benefit eligibility under the member’s benefit plan. Please refer to the member’s benefits document in effect at the time of the service to determine coverage or non-coverage as it applies to an individual member. See Plan reimbursement policies for Plan billing guidelines.

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

CPT Codes Description: Codes Covered When Medically Necessary 44133 Donor enterectomy (including cold preservation), open; partial, from living donor 44135 Intestinal allotransplantation; from cadaver donor 44136 Intestinal allotransplantation; from living donor HCPCS Codes Description: Codes Covered When Medically Necessary S2053 Transplantation of small intestine and liver allografts S2054 Transplantation of multivisceral organs

Plan note: Code is not payable for the Senior Care Options product.

Clinical Background Information A small bowel transplant is typically performed in individuals with short bowel syndrome (SBS). Parenteral nutrition is the mainstay of therapy for adults and children with SBS and other causes of intestinal failure. In infants, SBS is generally due to congenital anomalies. In adults, severe SBS usually occurs following a massive small bowel resection, which results in rapid intestinal transit and loss of absorptive function.

Small bowel, small bowel-liver and multivisceral transplantation can be a lifesaving procedure and has become the treatment of choice for patients with irreversible intestinal and/or multivisceral organ failure who can no longer be sustained on total parenteral nutrition (TPN). Combined small bowel-liver transplant is indicated when there is documented end-stage hepatic disease. Patients can survive total intestinal failure with TPN therapy. However, frequently patients lose the ability to tolerate long term TPN therapy secondary to liver failure, thrombosis of central veins, infections from central lines, and/or dehydration. Many factors can affect the outcomes of small bowel, small bowel-liver, and multivisceral transplantations; patient selection criteria are based on obtaining optimal results for each recipient.

At the time of the Plan’s most recent policy review, the Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) #260.5 for intestinal and multi-visceral transplantation states that intestinal and multi-visceral transplantations are covered by Medicare when performed for the purpose of restoring intestinal function in patients with irreversible intestinal failure who have failed total parenteral nutrition (TPN) and meet applicable CMS criteria. CMS defines intestinal failure as the loss of absorptive capacity of the small bowel secondary to severe primary gastrointestinal disease or surgically induced short bowel syndrome. Multi-visceral transplantation includes organs in the digestive system (stomach, duodenum, pancreas, liver and intestine). CMS requires that services be provided at a Medicare-approved liver transplant centers that perform intestine transplants, combined liver-intestine transplants, and multivisceral transplants (as specified in 42 CFR Parts 405, 482, 488, and 498 Medicare Program, Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers to Perform Organ Transplants, Final Rule, March 30, 2007). CMS evaluates detailed criteria for facility participation that include but are not limited to the following: Clinical experience, patient selection of suitable candidates, patient management,

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

maintenance of data, organ procurement, laboratory services, and billing guidelines. Senior Care Options members will have access to transplant services according all applicable CMS guidelines, including but not limited to the provisions specified in the Medicare Managed Care Manual, Chapter 4 – Benefits and Beneficiary Protections, 10.11 Transplant Services. Determine what applicable CMS criteria are in effect for pancreas or pancreas-kidney transplant services in an NCD or LCD on the date of the prior authorization request for a Senior Care Options member.

The U.S. Department of Health and Human Services (DHHS) has oversight responsibility for the organ allocation system in the United States. Congress established the Organ Procurement and Transplantation Network (OPTN) when it enacted the National Organ Transplant Act (NOTA) of 1984. The Act called for a unified transplant network to be operated by a private, nonprofit organization under federal contract. United Network for Organ Sharing (UNOS) was awarded the initial OPTN contract in 1986 and continues to administer the OPTN.

References Abu-Elmagd K, Bond G. Gut failure and abdominal visceral transplantation. Proc Nutr Soc 2003; 62:727.

Abu-Elmagd K, Reyes J, Bond G, et al. Clinical intestinal transplantation: a decade of experience at a single center. Ann Surg 2001; 234:404.

Abu-Elmagd K, Reyes J, Bond G, et al. A novel immunomodulatory strategy for clinical intestinal transplantation: Ex-vivo irradiation with adjunct bone marrow infusion. Program and abstracts of Transplant 2001: The Joint American Transplant Meeting; May 11-16, 2001; Chicago Illinois. Concurrent session 47: Small Bowel Transplantation; Abstract 912.

Abu-Elmagd K, Reyes J, Fung JJ. Clinical intestinal transplantation: recent advances and future consideration. In: Norman DJ, Turka LA, editors. Primer on transplantation. 2nd ed. Mt. Laurel, NJ: American Society of Transplantation; 2001. p. 610-25.

Abu-Elmagd KM, Costa G, Bond GJ, et al. Five hundred intestinal and multivisceral transplantations at a single center: major advances with new challenges. Ann Surg 2009; 250:567.

Abu-Elmagd KM. Intestinal transplantation for short bowel syndrome and gastrointestinal failure: current consensus, rewarding outcomes, and practical guidelines. Gastroenterology. 2006 Feb;130(2 Suppl 1):S132-7.

Abu-Elmagd KM, Kosmach-Park B, Costa G, et al. Long-term survival, nutritional autonomy, and quality of life after intestinal and multivisceral transplantation. Ann Surg 2012; 256:494.

Abu-Elmagd KM, Reyes J, Fung JJ, et al. Evolution of clinical intestinal transplantation: improved outcome and cost effectiveness. Transplant Proc 1999; 31:582.

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

American Gastroenterological Association (AGA). AGA Medical Position Statement: Short Bowel Syndrome and Intestinal Transplantation. Gastroenterology April 2003. Volume 124. Issue 4. Pages 1105-1110. Accessed at: http://www.gastrojournal.org/article/S0016-5085(03)00052-0/fulltext

American Gastroenterological Association (AGA). Guidelines. Accessed at: http://www.gastro.org/guidelines

American Society for Transplant Surgeons (ASTS). Draft Minimal Criteria for Designation as Transplant Surgeon. December 11, 2008. Accessed at: http://asts.org/docs/default-source/position- statements/draft---definition-of-a-transplant-surgeon-december-11-2008.pdf?sfvrsn=4

American Society of Transplantation (AST). Key Position Statements. Accessed at: https://www.myast.org/public-policy/key-position-statements

Benedetti E, Holterman M, Asolati M, et al. Living related segmental bowel transplantation: from experimental to standardized procedure. Ann Surg 2006; 244:694.

Braun F, Broering D, Faendrich F. Small intestine transplantation today. Langenbecks Arch Surg. 2007 May;392(3):227-38. Epub 2007 Jan 25.

Bowyer BA, Fleming CR, Ludwig J, et al. Does long-term home parenteral nutrition in adult patients cause chronic liver disease? JPEN J Parenter Enteral Nutr 1985; 9:11.

Brennan D, et al. Development of malignancy following solid organ transplantation UpToDate OnLine 2013 http://www.uptodate.com/contents/development-of-malignancy-following-solid-organ- transplantation?topicKey=NEPH%2F7304&elapsedTimeMs=7&source=see_link&view=print&displayed View=full

Buchman AL, Scolapio J, Fryer J. AGA technical review on short bowel syndrome and intestinal transplantation. Gastroenterology 2003; 124:1111.

Carrasco FR, Moreno A, Ridao N, Calvo N, Pérez-Flores I, Rodríguez A, Sánchez A, Marques M, Barrientos. Kidney transplantation complications related to psychiatric or neurological disorders. Transplant Proc; 2009 Jul-Aug;41(6):2430-2. doi: 10.1016/j.transproceed.2009.06.166. Accessed at: http://www.ncbi.nlm.nih.gov/pubmed/19715942

Centers for Disease Control and Prevention (CDC). Transplant Safety. Guidelines. Accessed at: http://www.cdc.gov/transplantsafety/hc-providers/guidelines.html

Centers for Medicare & Medicaid Services (CMS). Conditions for Coverage (CfCs) & Conditions of Participations (CoPs). Transplant Centers. Accessed at: https://www.cms.gov/Regulations-and- Guidance/Legislation/CFCsAndCoPs/transplantcenters.html Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

Centers for Medicare & Medicaid Services (CMS). Medicare Approved Transplant Programs. Program Type: Intestinal and/or Multivisceral. Accessed at: https://www.cms.gov/Medicare/Provider- Enrollment-and-Certification/CertificationandComplianc/Downloads/ApprovedTransplantPrograms.pdf

Centers for Medicare & Medicaid Services (CMS). Medicare Managed Care Manual. Chapter 4 – Benefits and Beneficiary Protections. 10.11 Transplant Services. Rev 121. Issued April 22, 2016. Accessed at: https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/downloads/mc86c04.pdf

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Intestinal and Multi-Visceral Transplantation (260.5). 2006. Accessed at: http://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=280&ncdver=2&DocID=260.5&SearchType=Advanced&bc=IAAAABAAAAAA&

Centers for Medicare & Medicaid Services (CMS). Transplant. Accessed at: https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/CertificationandComplianc/Transplant.html

Centers for Medicare & Medicaid Services (CMS). Welcome to the Medicare Coverage Database. Accessed at: https://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx

Chen YB. Mesenteric Venous Thrombosis. MedlinePlus. Updated 05/29/14. Accessed at: http://www.nlm.nih.gov/medlineplus/ency/article/001157.htm

Chungfat N, Dixler I, Cohran V, et al. Impact of parenteral nutrition-associated liver disease on intestinal transplant waitlist dynamics. J Am Coll Surg 2007; 205:755.

Commonwealth of Massachusetts. MassHealth Guidelines for Medical Necessity Determination for Organ Transplantation Procedures. MG-ORG (11/14). Accessed at: http://www.mass.gov/eohhs/docs/masshealth/guidelines/mg-organtransplants.pdf

Fiel MI, Sauter B, Wu HS, et al. Regression of hepatic fibrosis after intestinal transplantation in total parenteral nutrition liver disease. Clin Gastroenterol Hepatol 2008; 6:926.

Fischer SA, Lu K, and AST Infectious Diseases Community of Practice. The American Society of Transplantation and the American Society of Transplant Surgeons. Screening of Donor and Recipient in Solid Organ Transplantation. American Journal of Transplantation 2013; 13: 9–21. doi: 10.1111/ajt.12094. Accessed at: http://www.coordinaciontrasplantes.org/images/bibliografia/06- 04.pdf

Fishbein TM. Intestinal transplantation. N Engl J Med. 2009 Sep 3;361(10):998-1008.

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

Flynn B, Park BK, Bond G, et al. Immunosuppressant strategies for intestinal transplantation: a review of a tolerogenic regimen. Prog Transplant 2005; 15:60.

Grant D, Abu-Elmagd K, Reyes J, Tzakis A, Lagnas A, Fishbein T, et al. 2003 report of the intestine transplant registry: a new era has dawned. Ann Surg. 2005 Apr;241(4):607-13.

Haghighi KS, Sharif K, Mirza DF, et al. Surgical complications of intestinal transplantation. Transplantation 2006; 82(1 Suppl 2):466.

Hauser GJ, Kaufman SS, Matsumoto CS, Fishbein TM. Pediatric intestinal and multivisceral transplantation: a new challenge for the pediatric intensivist. Intensive Care Med. 2008 Sep;34(9):1570-9.

Hayes Health Technology Brief. Living Related Donor Small Bowel Transplantation for Intestinal Failure. Winifred Hayes, Inc. June 26, 2014. Annual Review April 22, 2016.

Kato T, Tzakis AG, Selvaggi G, et al. Intestinal and multivisceral transplantation in children. Ann Surg 2006; 243:756.

Kaufman SS, Atkinson JB, Bianchi A, et al. Indications for pediatric intestinal transplantation: a position paper of the American Society of Transplantation. Pediatric Transplant. 2001; 5(2):80-87.

Khan FA and Selvaggi G. Overview of intestinal and multivisceral transplantation. UpToDate. January 8, 2016. Accessed at: http://www.uptodate.com/contents/overview-of-intestinal-and-multivisceral- transplantation

Knoll G, Cockfield S, Blydt-Hansen T, et al. Canadian Society of Transplantation consensus guidelines on eligibility for kidney transplantation. CMAJ 2005; 173:1181

Kubak C, et al. Intestinal and Multivisceral Transplantation: Current Status and Future Directions. Curr Gastroenterol Rep 2015;17:5.

Interlink Health Services, Inc. Transplant Reference Guide Small Bowel & Multivisceral Transplant. Version 5.0.

Iyer KR, Iverson AK, DeVoll-Zabrocki A, et al. Pediatric intestinal transplantation--review of current practice. Nutr Clin Pract 2002; 17:350.

Kato T, Gaynor JJ, Nishida S, et al. Zoom endoscopic monitoring of small bowel allograft rejection. Surg Endosc 2006; 20:773.

Kato T, Selvaggi G, Gaynor JJ, et al. Inclusion of donor colon and ileocecal valve in intestinal transplantation. Transplantation 2008; 86:293. Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

LaMattina J, et al. Complications associated with liver transplantation in the obese recipient. Clinical transplantation 2012;26:910-918.

Lauro A, Altimari A, Di Simone M, et al. Acute cellular rejection monitoring after intestinal transplant: utility of serologic markers and zoom videoendoscopy as support of conventional biopsy and clinical findings. Transplant Proc 2008; 40:1575.

Levi DM, Tzakis AG, Kato T, et al. Transplantation of the abdominal wall. Lancet 2003; 361:2173.

Llado L, et al. Management of portal vein thrombosis in liver transplantation: influence on morbidity and mortality. Clinical Transplantation. 2007;21: 716721.

Mangus RS, Kubal CA, Fridell JA, Tector AJ. Multivisceral Transplantation for Non-Resectable Abdominal Neuroendocrine Tumors. Gastroenterology, 2014. 146(5): p. S-1031.

Martin LJ. Transplant Rejection. MedlinePlus. U. S. National Library of Medicine. Updated January 5, 2017. Accessed at: https://medlineplus.gov/ency/article/000815.htm

Matarese LE, Costa G, Bond G, Stamos J, Koritsky D, O’Keefe SJ, et al. Therapeutic efficacy of intestinal and multivisceral transplantation: survival and nutrition outcome. Nutr Clin Pract. 2007 Oct;22(5):474- 81.

Mazariegos GV, Abu-Elmagd K, Jaffe R, et al. Graft versus host disease in intestinal transplantation. Am J Transplant 2004; 4:1459.

Millar AJ, Gupte G, Sharif K. Intestinal transplantation for motility disorders. Semin Pediatr Surg. 2009;18(4):258-262.

Morris MI. Pre-transplant Recipient Evaluation & Management. 2011. Accessed at: http://www.antimicrobe.org/

Mueller AR, Pascher A, Platz KP, et al. Immunosuppression following intestinal transplantation. Transplant Proc 2004; 36:325.

Nathan JD, Rudolph JA, Kocoshis SA, Alonso MH, Ryckman FC, Tiao GM. Isolated liver and multivisceral transplantation for total parenteral nutrition-related end-stage liver disease. J Pediatr Surg. 2007 Jan;42(1):143-7.

Nayyar N, et al. Pediatric small bowel transplantation. Semin Pediatr Surg 2010 Feb;19(1):68-77.

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

Nucci A, Cartland Burns R, Armah T, Lowery K, Yaworski JA, Strohm M, et al. Interdisciplinary management of pediatric intestinal failure: A 10-Year review of rehabilitation and transplantation. J Gastrointest Surg. 2008 Mar;12(3):429-35. Epub 2007 Dec 18.

O’Keefe SJD. Buchman AL, Fishbein TM, Jeejeebhoy KN, Jeppesen PB, Shaffer J. Short Bowel Syndrome and Intestinal Failure: Consensus Definitions and Overview. Clinical Gastroenterology and Hepatology 4(1):6-10 · February 2006. ResearchGate. Accessed at: https://www.researchgate.net/publication/7342438_Short_Bowel_Syndrome_and_Intestinal_Failure_ Consensus_Definitions_and_Overview

O'Keefe SJ, Emerling M, Koritsky D, et al. Nutrition and quality of life following small intestinal transplantation. Am J Gastroenterol 2007; 102:1093.

Olausson M, Friman S, Herlenius G, Cahlin C, Nilsson O, Jansson S, et al. Orthotopic liver or multivisceral transplantation as treatment of metastatic neuroendocrine tumors. Liver Transpl. 2007 Mar;13(3):327-33.

Organ Procurement and Transplantation Network (OPTN). U. S. Department of Health & Human Services. OPTN/United Network for Organ Sharing (UNOS) Ethics Committee: Ethical Principles to be Considered in the Allocation of Human Organs. June 2, 2015. Accessed at: https://optn.transplant.hrsa.gov/resources/ethics/ethical-principles-in-the-allocation-of-human- organs/

Organ Procurement and Transplantation Network (OPTN). U. S. Department of Health & Human Services. Organ Procurement and Transplantation Network. Accessed at: https://optn.transplant.hrsa.gov/

Organ Procurement and Transplantation Network (OPTN). U. S. Department of Health & Human Services. Policies. January 1, 2017. Accessed at: https://optn.transplant.hrsa.gov/governance/Policies/

Organ Procurement and Transplantation Network (OPTN). U. S. Department of Health & Human Services. Resources: Allocation Calculators. Accessed at: https://optn.transplant.hrsa.gov/resources/allocation-calculators/

Parizhskaya M, Redondo C, Demetris A, et al. Chronic rejection of small bowel grafts: pediatric and adult study of risk factors and morphologic progression. Pediatr Dev Pathol 2003; 6:240.

Pironi L. et al. Long-term follow-up of patients on home parenteral nutrition in Europe: implications for intestinal transplantation. Gut. 2011 Jan;60(1):17-25. Epub 2010 Nov 10.

Pironi L, Forbes A, Joly F, Colomb V, Lyszkowska M, Vam Gossum A, et al. Survival of patients identified as candidates for intestinal transplantation: a 3-year prospective follow-up. Gastroenterology. 2008 Jul;138(1):61-71.Epub 2008 Mar 26. Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

Reyes JD. Intestinal transplantation. Semin Pediatr Surg 2006; 15:228.

Reyes J, Mazariegos GV, Abu-Elmagd K, et al. Intestinal transplantation under tacrolimus monotherapy after perioperative lymphoid depletion with rabbit anti-thymocyte globulin (thymoglobulin). Am J Transplant 2005; 5:1430.

Reyes J, Mazariegos GV, Bond GM, et al. Pediatric intestinal transplantation: historical notes, principles and controversies. Pediatr Transplant 2002; 6:193.

Sander, F. Decision Making in Intestinal Transplantation. North American Transplant Coordinators Organization. March 2005.

Scientific Registry of Transplant Recipients (SRTR). The SRTR/Organ Procurement Transplant Network (OPTN) Annual Data Report. Statistics on donation and transplantation in the United States. January 3, 2017. Accessed at: https://www.srtr.org/reports-tools/srtroptn-annual-data-report/

Selvaggi G, Gaynor JJ, Moon J, et al. Analysis of acute cellular rejection episodes in recipients of primary intestinal transplantation: a single center, 11-year experience. Am J Transplant 2007; 7:1249.

Selvaggi G, Gyamfi A, Kato T, et al. Analysis of vascular access in intestinal transplant recipients using the Miami classification from the VIIIth International Small Bowel Transplant Symposium. Transplantation 2005; 79:1639.

Selvaggi G, Tzakis A. Pediatric intestinal transplantation: literature review 2006-2007. Pediatr Transplant. 2008 Dec;12(8):827-34.Epub 2008 Jul 30.

Steinman, Theodore, et al. Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation. Transplantation. Vol. 71, 1189-1204, No. 9, May 15, 2001.

Sudan D. Cost and quality of life after intestinal transplantation. Gastroenterology 2006; 130:S158.

Sudan D, Horslen S, Botha J, et al. Quality of life after pediatric intestinal transplantation: the perception of pediatric recipients and their parents. Am J Transplant 2004; 4:407.

Todo S, Reyes J, Furukawa H, et al. Outcome analysis of 71 clinical intestinal transplantations. Ann Surg 1995; 222:270.

Troppman C et al. (2001). Intestinal Transplantation in Holzheimer RG and Mannick JA (Ed.). Surgical Treatment - Evidence-Based and Problem-Oriented. Munich: Zuckschwerdt. 2001. ISBN-10: 3-88603- 714-2.

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

United Network for Organ Sharing (UNOS). Appendix B of UNOS Bylaws. Designated Transplant Program Criteria. Attachment I. XIII – Transplant Programs. June 28-29, 2011. Accessed at: https://www.unos.org/wp-content/uploads/unos/Appendix_B_AttachI_XIII.pdf

U.S. Food and Drug Administration. Vaccines, Blood & Biologics. Human Cells or Tissues Intended for Transplant into a Human Recipient that Have Ex-vivo Contact with Live Non-human Animal Cells, Tissues or Organs Letter. March 8, 2002. Accessed at: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm136703.htm

U.S. Food and Drug Administration. Vaccines, Blood & Biologics. Information and Recommendations for Physicians Involved in the Co-Culture of Human Embryos with Non-Human Animal Cells. April 30, 2009. Accessed at: http://www.fda.gov/BiologicsBloodVaccines/Xenotransplantation/ucm136532.htm

Vianna R, et al. Multivisceral Transplantation for Diffuse Portomesenteric Thrombosis. Annals of Surgery 2012;255:144-150

Vianna R, Fridell JA, Mangus R, et al. Safe inclusion of the entire pancreas as a component of the multivisceral graft. Transplantation 2008; 86:114.

Vianna RM, Mangus RS. Present prospects and future perspectives of intestinal and multivisceral transplantation. Curr Opin Clin Nutr Metab Care. 2009; 12(3):281-286.

Vianna RM, Mangus RS, Tector AJ. Current status of small bowel and multivisceral transplantation. Adv Surg. 2008;42:129-150.

Wu T, Abu-Elmagd K, Bond G, et al. A schema for histologic grading of small intestine allograft acute rejection. Transplantation 2003; 75:1241.

Original Effective Original Approval Original Policy Date* and Version Policy Owner Date Approved by Number Regulatory Approval: N/A 10/02/05 Medical Policy Manager Quality and Clinical Version 1 as Chair of Medical Policy, Management Committee Internal Approval: Criteria, and Technology (Q&CMC) 08/02/05 Assessment Committee (MPCTAC) *Effective Date for the BMC HealthNet Plan Commercial Product(s): 01/01/12 *Effective Date for the Well Sense Heath Plan New Hampshire Medicaid Product(s): 01/01/13 *Effective Date for Senior Care Options Product(s): 01/01/16

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

Policy Revisions History Revision Effective Date Review Date Summary of Revisions Approved by and Version Number 02/06/07 Updated template and references. Version 2 02/06/07: Q&CMC 02/19/08 Revised clinical criteria. Version 3 02/19/08: MPCTAC 02/26/08: Utilization Management Committee (UMC) 03/12/08: QIC 02/24/09 Updated clinical criteria for HIV, Version 4 02/24/09: MPCTAC updated coding and references. 02/24/09: UMC 03/25/09: QIC 02/01/10 Updated references. Version 5 02/22/10: MPCTAC 03/24/10: QIC 02/01/11 Updated adult and pediatric clinical Version 6 03/16/11: MPCTAC indications, updated references. 04/27/11: QIC 03/13/12 Updated references, clarified two Version 7 03/21/12: MPCTAC contraindications. 04/25/12: QIC 08/01/12 Off cycle review for Well Sense Health Version 8 08/13/12: MPCTAC Plan, revised Summary statement, 09/06/12: QIC reformatted and revised Medical Policy

Statement, revised Applicable Coding introductory paragraph, revised Limitations. 03/01/13 Review for effective date 07/01/13. 07/01/13 03/20/13: MPCTAC Revised title, updated and added Version 9 04/18/13: QIC references, revised Summary section, moved description of multivisceral transplant from Definition section to Description of Item or Service section, and added small bowel-liver transplant to Description of Item or Service. Reformatted, revised, and added medical criteria in Medical Policy Statement section (formerly titled the Clinical Guidelines Statement section). Added limitations and moved contraindications from Medical Policy Statement section to Limitations section. Moved criteria for failed TPN therapy from Clinical Background Information section to the Medical Policy Statement section. Deleted Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

Policy Revisions History HCPCS code S2055 from applicable code list and revised language in Applicable Coding section. Revised text in Clinical Background Information section and changed name of policy category from “Clinical Coverage Guidelines” to “Medical Policy.” Referenced Medically Necessary policy, Reimbursement Guidelines: Serious Reportable Event/Provider Preventable Condition policy, and Experimental and Investigational Treatment policy. 08/14/13 and Off cycle review for Well Sense Health Version 10 08/14/13: MPCTAC 08/15/13 Plan and merged policy format. (electronic vote) Incorporate policy revisions dated 08/15/13: QIC 03/01/13 (as specified above) for the Well Sense Health Plan product; these policy revisions were approved by MPCTAC on 03/20/13 and QIC on 04/18/13 for applicable Plan products. 03/01/14 Review for effective date 07/0/1/14. 07/01/14 03/19/14: MPCTAC Revised and reformatted criteria in the Version 11 04/16/14: QIC Medical Policy Statement section and Limitations section. Updated references. 12/01/14 Review for effective date 03/01/15. 03/01/15 12/02/14: MPCTC Removed CPT code 44132 from the list Version 12 (electronic vote) of codes requiring prior authorization. 12/10/14: QIC 03/01/15 Review for effective date 07/01/15. 07/01/15 03/18/15: MPCTAC Updated Summary, Definitions, and Version 13 04/08/15: QIC References sections. Revised criteria in the Medical Policy Statement section. Removed Commonwealth Care, Commonwealth Choice, and Employer Choice from the list of applicable products because the products are no longer available. 11/25/15 Review for effective date 01/01/16. 01/01/16 11/18/15: MPCTAC Updated template with list of Version 14 11/25/15: MPCTAC applicable products and notes. Revised (electronic vote) language in the Applicable Coding 12/09/15: QIC section. 03/01/16 Review for effective date 07/01/16. 07/01/16 03/16/16: MPCTAC Updated Summary, Description of Item Version 15 04/13/16: QIC

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

Policy Revisions History or Service, Clinical Background Information, References, and Reference to Applicable Laws and Regulations sections. Revised criteria in the Limitations section. 03/01/17 Review for effective date 06/07/17. 06/07/17 03/15/17: MPCTAC Administrative change made to the Version 16 Summary, Limitations, Definitions, Clinical Background Information, and References sections. Updated criteria in the Medical Policy Statement section. Plan note added to the Applicable Coding section.

Last Review Date 03/01/17

Next Review Date 03/01/18

Authorizing Entity MPCTAC

Other Applicable Policies Administrative Policy – Clinical Criteria, policy number OCA 3.201 Administrative Policy – Transplantation Administration, policy number OCA 3.10 Medical Policy – Experimental and Investigational Treatment, policy number OCA 3.12 Medical Policy – Medically Necessary, policy number OCA 3.14 Medical Policy – Transplantation of Lung or Lobar Lung, policy number OCA 3.24 Medical Policy – Transplantation of Pancreas or Pancreas-Kidney, policy number OCA 3.25 Reimbursement Policy – Anesthesia, policy number 4.103 Reimbursement Policy – General Billing and Coding Guidelines, policy number 4.31 Reimbursement Policy – General Clinical Editing and Payment Accuracy Review Guidelines, policy number 4.108 Reimbursement Policy – Inpatient Hospital, policy number 4.110 Reimbursement Policy – Outpatient Hospital, policy number 4.17 Reimbursement Policy – Physician and Non Physician Practitioner Services, policy number 4.608

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

Reference to Applicable Laws and Regulations 42 CFR Parts 405, 482, 488, and 498. Code of Federal Regulations. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers to Perform Organ Transplants. Final Rule. March 30, 2007. Accessed at: https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/GuidanceforLawsAndRegulations/Downloads/TransplantFinalLawandReg.pdf

42 U.S. Code § 274. United States Code. Public Health Service (PHS) Act. Organ Procurement and Transplantation Network. Accessed at: https://www.law.cornell.edu/uscode/text/42/274

78 FR 48164-69. Federal Register. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Revised Process for Making National Coverage Determinations. August 7, 2013. Accessed at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf

130 CMR 415.400. Commonwealth of Massachusetts. Code of Massachusetts Regulations. Division of Medical Assistance. MassHealth Provider Manual Series. Acute Inpatient Hospital Manual. Transmittal Letter AIH-52. January 2, 2015. Accessed at: http://www.mass.gov/eohhs/docs/masshealth/regs- provider/regs-acuteinpathosp.pdf

130 CMR 433.000. Commonwealth of Massachusetts. Code of Massachusetts Regulations. Division of Medical Assistance. MassHealth Provider Manual Series. Physician Manual. Transmittal Letter PHY-140. January 1, 2014. Accessed at: http://www.mass.gov/eohhs/docs/masshealth/regs-provider/regs- physician.pdf

130 CMR 450.000. Commonwealth of Massachusetts. Code of Massachusetts Regulations. Division of Medical Assistance. Administrative and Billing Regulations. Accessed at: http://www.mass.gov/courts/docs/lawlib/116-130cmr/130cmr450.pdf

Centers of Medicare & Medicaid Services (CMS). State Operations Manual. Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals. Rev. 151. 11-20-15. Accessed at: https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/Downloads/som107ap_a_hospitals.pdf

Chapter He-W 500 Medical Assistance. New Hampshire Code of Administrative Rules. Accessed at: http://www.gencourt.state.nh.us/rules/state_agencies/he-w500.html

New Hampshire Medicaid. Hospitals, Hospital-Based Rural Health Clinics (RHC-HB), and Swing Bed Hospitals.* Provider Manual. Volume II. December 2014. Accessed at: https://nhmmis.nh.gov/portals/wps/wcm/connect/429d638046994cefad10ad1f788f24c7/NH+Medicai d+Final+Hospital+Provider+Manual+12-12-14.pdf?MOD=AJPERES

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs

Disclaimer Information: + Medical Policies are the Plan’s guidelines for determining the medical necessity of certain services or supplies for purposes of determining coverage. These Policies may also describe when a service or supply is considered experimental or investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as the Member’s benefit document, and when appropriate, coordinates with the Member’s health care Providers to consider the individual Member’s health care needs. Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan’s service area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable state or federal mandates, as well as the Member’s benefit document, take precedence over these guidelines. Policies are reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the medical advice and treatment of Members. The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated. Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical necessity; utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and procedures; clinical coding criteria; claim editing logic; and the applicable Plan – Provider agreement.

Transplantation of Small Bowel, Small Bowel-Liver, or Multivisceral Organs