MEDICAL POLICY Transplant Prior Authorization …...A heart transplant is the last resort for persons with end-stage cardiac disease where all other treatments have failed. Causes

PG0461 – 12012020

Transplant Prior Authorization and Notification Policy Number: PG0461 Last Review: 12/1/2020

GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement.

SCOPE X Professional X Facility DESCRIPTION Transplant Services include non-experimental human organ transplant of an organ or tissue from one person to another or grafting living tissue from its normal position to another site. Transplant procedures include: heart transplants, liver transplants, lung or double lung transplants, simultaneous pancreas and kidney transplants, small bowel transplants, multi-visceral transplants, stem cell/bone marrow transplants, donor leukocyte infusion transplants. Including any additional multiple organ combination transplants. Transplant Prior Authorization and Notification Process

Prior to selecting a transplant provider, submission of a Transplant Prior Authorization is required from the referring provider. This Prior Authorization will support the initiation of care and benefit coordination.

Prior Authorization is required before the actual visit for the pre-transplant evaluation as outlined below on the Policy table.

o Exception: for the Elite/ProMedica Medicare Plan product lines, Prior Notification is requested from the ordering/referring provider before the actual visit date for pre-transplant evaluations

Prior Authorization is required at the time of pre-transplant listing or start of treatment for deemed transplant candidate.

Prior Authorization is required for All Out-Patient Services related to a transplant evaluation. o Prior authorization for these Out-Patient Services must include a list of all procedures,

including the CPT codes, to be performed as part of the transplant work up. o Exception: for the Elite/ProMedica Medicare Plan product lines, Prior Authorization is

required only for Out-Patient Facility services related to a transplant evaluation.

The prior authorization requirements are not a barrier to the OH Solid Organ Transplant Consortium or the OH Hematopoietic Stem Cell Transplant Consortium but rather a means to direct and guide members to Centers of Excellence (reference Medicaid Managed Care Appendix G, Section H, Paragraph ii and I). The prior authorization will support the initiation of care and benefit coordination.

See details below on the Policy table.

ADVANTAGE | ELITE | HMO INDIVIDUAL MARKETPLACE |

PROMEDICA MEDICARE PLAN | PPO

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A transplant is indicated when the member meets the transplanting institution’s protocol eligibility criteria. Paramount encourages ONE transplant evaluation, allowing the ‘sharing’ of the initial evaluation, testing/imaging/workup, unless additional medically necessary information is required. The Organ Procurement and Transplantation Network (OPTN) links all of the providers (professional and facilities) involved in the nation’s organ donation and transplantation system. OPTN is a private, non-profit organization under a federal contract that guarantees fairness in the allocation of organs for transplant. All transplant programs and organ procurement organizations are members of the OPTN and agree to follow its policies. There are 58 organ procurement organizations (OPO) nationwide. Specific criteria for prioritizing donor thoracic organs for transplant are provided by the Organ Procurement and Transplantation Network (OPTN) and implemented through a contract with The United Network for Organ Sharing (UNOS). UNOS maintains a database of all individuals waiting for kidney, heart, liver, lung, intestine and multiple-organ transplants. Donor thoracic organs are prioritized by UNOS based on recipient medical urgency, distance from donor hospital, and pediatric status. Patients who are most severely ill (status 1A) are given highest priority. Special accommodations are given to children under certain circumstances. To become a transplant candidate, the patient must be evaluated and accepted by a transplant hospital. This involves completing an evaluation form and agreeing to meet any conditions set by the hospital transplant program. The OPTN considers three levels when determining organ transplant matches, local organ procurement organizations (where the organ donation occurs), region or zone procurement organizations (500 miles, then 1,000 miles, then 1, 500 Miles of donor site), and nationwide procurement organizations.

Website: www.transplantliving.org and http://optn.transplant.hrsa.gov Organ Procurement Organizations (local) Lifeline of Ohio promotes and coordinates the donation of organs and tissues in 37 Ohio counties along with Wood and Hancock counties in West Virginia. Three other independently designated Organ Procurement Organizations also serve Ohio: LifeBanc in Cleveland, serving Northeast Ohio; LifeConnection of Ohio in Dayton and Toledo, serving Western Ohio; and Life Center Organ Donor Network in Cincinnati, serving Southwestern Ohio. Michigan has two Organ Procurement Organizations, Gift of Life Michigan and University of Wisconsin Hospital (NW Michigan).

With any transplant listing, the member must first be considered, approved and accepted by a transplant center/facility.

Multiple listing involves registering at two or more transplant centers. Since candidates at centers local to the donor hospital are usually considered ahead of those who are more distant, multiple listing may increase a members chances of receiving a local organ offer. However, the benefit from listing at multiple centers in the same local allocation area is not a benefit, since waiting time priority is first calculated among candidates at all hospitals within the local donation area and not for each hospital, regional listings are considered. Being listed in more than one area does not guarantee an organ will become available faster than for individuals registered at only on transplant hospital. Each hospital may have its own rules for allowing its patients to be on the list at another hospital.

o Members must first be accepted by a transplant center o Completing an evaluation. o Agree to meet any conditions set by the program

Ability to come to the hospital within a certain time if called for an organ offered

Factors considered for available organs include o Blood and tissue type o Medical urgency o Body size o Distance between the donor and transplant hospital o Time spent waiting for a transplant

http://www.transplantliving.org/

http://optn.transplant.hrsa.gov/

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Organ procurement considers candidates within 500 miles of the donor site, then 1,000 miles, then 1,500 miles.

The factors below are potential contraindications subject to the judgment of the transplant center:

Known current malignancy, including metastatic cancer

Recent malignancy with high risk of recurrence

Untreated systemic infection making immunosuppression unsafe, including chronic infection

Other irreversible end-stage disease not attributed to transplant requested

History of cancer with a moderate risk of recurrence

Systemic disease that could be exacerbated by immunosuppression

Psychosocial conditions or chemical dependency affecting ability to adhere to therapy.

Website: www.transplantliving.org and http://optn.transplant.hrsa.gov Paramount’s Transplant Centers of Excellence

Transplant Center of Excellence (COE) is any health care provider, group or association of health care providers designated by Paramount to provide services, supplies or drugs for the specified transplant performed on a covered person. Paramount’s COEs are determined by volume of transplants completed, patient survival rate, donor-to-transplant access, and contracted cost metrics. COEs are specific to each organ, product line and adult/pediatric. All COE determinations and metrics will be evaluated annually. Transplant programs that have not been designated as a COE may request reconsideration at any time. All reconsiderations should be requested in writing and directed to the following address:

Paramount

Director, Utilization Management

1901 Indian Wood Circle

Maumee, OH 43537

All updates will be communicated to Paramount’s Provider Network and the Medical Policy will be updated.

Source: Scientific Registry of Transplant Recipients https://www.srtr.org/transplant-centers/?query=&distance=50&location=&state=OH&recipientType=adult&organ=liver&sort=transplantRate

Note: A member who was approved at a COE but that COE was removed from the list due to the yearly COE review will not be required to go through an additional prior authorization process. Continuity of care will be maintained and the prior authorization honored.

POLICY

Transplant Prior-Authorization and Notification Requirements Paramount requires prior authorization of all transplant services before the services are provided.

HMO, PPO, Individual Marketplace, Advantage, Elite/ProMedica Medicare Plan Transplant procedures include: heart transplants, liver transplants, lung or double lung transplants, simultaneous pancreas and kidney transplants, small bowel transplants, multi-visceral transplants, stem cell/bone marrow transplants, donor leukocyte infusion transplants. Including any additional multiple organ combination transplants. When a member is identified as a potential candidate for a transplant, A Transplant Prior Authorization/Notification Request is to be initiated with Paramount Healthcare.

http://www.transplantliving.org/

http://optn.transplant.hrsa.gov/

https://www.srtr.org/transplant-centers/?query=&distance=50&location=&state=OH&recipientType=adult&organ=liver&sort=transplantRate


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Paramount’s transplant care management can be contacted to request Transplant Notification and Prior Authorization Request at: TRANSPLANT PRIOR NOTIFICATION REQUEST Fax Number: 866-214-2024 or 567-661-0842 Attention: Transplant Case Manager https://www.paramounthealthcare.com/services/providers/prior-authorization-criteria/ EFFECTIVE 10/01/2020

Product Line Transplant Evaluation***: Prior Authorization and Notification

Transplant Procedure*: Prior Authorization and Notification

Paramount Advantage

Step 1: The PCP/specialist must submit the Prior Authorization request for the Transplant Evaluation to Paramount prior to the actual visit date Step 2: All outpatient services related to a transplant evaluation require a prior authorization before the actual visit date. This request (including procedure codes) may be submitted by the provider of the transplant evaluation previously authorized by Paramount in Step 1.

Transplant Procedure Prior authorization for the

transplant medical procedure itself is required only if requesting

authorization at a facility outside of the list of Paramount COEs**

Prior notification for the transplant medical procedure itself is required when performed at a facility listed

on Paramount’s COEs.

Transplant Inpatient Admissions Authorization is required at both

Paramount Transplant Centers of Excellence and non-Paramount

Transplant Centers of Excellence for all inpatient admissions to ensure coverage and prompt

claims payment.

Paramount Commercial Fully-Funded

and Self-Funded****

Step 1: The PCP/specialist must submit the Prior Authorization request for the Transplant Evaluation to Paramount prior to the actual visit date Step 2: All outpatient services related to a transplant evaluation require a prior authorization before the actual visit date. This request (including procedure codes) may be submitted by the provider of the transplant evaluation previously authorized by Paramount in Step 1.




Prior notification for the transplant procedure itself is required when performed at a facility listed on

Paramount’s COEs**.




claims payment.

https://www.paramounthealthcare.com/services/providers/prior-authorization-criteria/

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Paramount Elite/ProMedica Medicare Plan

Step 1: A prior authorization is NOT required for the initial transplant evaluation for Participating Providers. (Non Participating Providers are required to obtain prior authorization for ALL nonemergent services BEFORE services are rendered.) Step 2: All outpatient services related to a transplant evaluation do require a prior authorization before the actual visit date. This request (including procedure codes) may be submitted by the provider of the transplant evaluation OR the PCP/specialist initiating the transplant evaluation




Prior notification for the transplant procedure itself is required when performed at a facility listed on

Paramount’s COEs**.




claims payment.

*Transplant procedures include: heart transplants, liver transplants, kidney transplants, corneal transplants, lung or double lung transplants, simultaneous pancreas and kidney transplants, intestine transplants (includes small bowel transplants and multi-visceral transplants), bone marrow/stem cell transplants, and donor-leukocyte transplants. Including any additional multiple organ combination transplants **Paramount COEs for each organ and each product line is identified below, as referenced in the medical policy. COEs are determined by quality, volume, outcome, and cost metrics. https://www.srtr.org/transplant-centers/?query=&distance=50&location=&state=OH&recipientType=adult&organ=liver&sort=transplantRate ***Excluding cornea and donor leukocyte transplants. Corneal transplants are outside the scope of this policy. Corneal transplants are covered without prior evaluation authorization or notification. A prior authorization is required for the transplant surgical procedure. **** Encompasses both Fully-Funded and Self-Funded, “or as otherwise outlined in self-funded documentation” Advantage The prior authorization requirements are not a barrier to the OH Solid Organ Transplant Consortium or the OH Hematopoietic Stem Cell Transplant Consortium but rather a means to direct and guide members to Centers of Excellence (reference Medicaid Managed Care Appendix G, Section H, Paragraph ii and I). The prior authorization will support the initiation of care and benefit coordination. Elite/ProMedica Medicare Plan Organ transplantation is covered when performed in a facility approved by Medicare as meeting institutional coverage criteria, Medicare National Coverage. The Centers for Medicare & Medicaid Services has stated that, under certain limited cases, exceptions to the criteria may be warranted if there is justification and if the facility ensures safety and efficacy objectives.




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Non Participating Providers are required to obtain prior authorization for ALL nonemergent services BEFORE services are rendered.

HMO, PPO, Individual Marketplace, Advantage, Elite/ProMedica Medicare Plan When a member is identified as a potential candidate for a transplant, Paramount requires a Transplant Prior Authorization or Prior Notification from the referring provider, as addressed in the table above. This is to be initiated before the selection of the Transplant Facility Evaluation. This allows for the best steerage for the patient/member outcome. Sufficient documentation or information must be included with the transplant prior notification/authorization request, supporting the medical necessity of the service. Transplant Prior Notification Process

Prior to selecting a transplant center, a provider submission Transplant Prior Authorization/Notification from the referring physician is required. This prior authorization/notification request will support the initiation of care and benefit coordination.

o Transplant physician’s evaluation o Summary of the multi-disciplinary assessments o Any additional documentation assessments supporting the transplant authorization/notification

request.

Transplant Prior Authorization/Notification is required before the actual visit date for pre-transplant evaluation.

Transplant Prior Authorization/Notification is required at the time of pre-transplant listing or start of treatment for deemed transplant candidate.

In the case of an emergency when a Transplant Prior Authorization/Notification cannot be submitted before the transplant service is rendered, the necessary and appropriate emergency transplant service should be provided. Complete the Transplant Prior Authorization Notification request and write “emergency” across the top of the request. Paramount reviews referral requests for transplant authorization utilizing OPTUM® transplant Review Guidelines. Transplant Center of Excellence is any health care provider, group or association of health care providers designated by Paramount to provide services, supplies or drugs for the specified transplant performed on a covered person. Paramount’s Transplant Centers of Excellent Quality Metrics are identified through the Scientific Registry of Transplant Recipients. https://www.srtr.org/about-srtr/mission-vision-and-values/ Heart Transplants A heart transplant is a life-saving operation to replace a diseased heart that is failing to function adequately with a healthy heart from an organ donor. A heart transplant is the last resort for persons with end-stage cardiac disease where all other treatments have failed. Causes of Heart Failure and Heart Transplant may include, but not limited to, one of the following diagnoses:

Coronary heart disease

Congenital heart disease

Valvular heart disease

Damaged heart muscles

Cardiac arrhythmia

Cardiomyopathy due to nutritional, metabolic, hypertrophic or restrictive etiologies

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Viral infections of the heart, Myocarditis

Inability to be weaned from temporary cardiac-assist devices after myocardial infarction or non-transplant cardiac surgery

Heart organ procurement considers candidates within 500 miles of the donor site, then 1,000 miles, then 1,500 miles. However, most heart transplant recipients are hospitalized as status 1 (mechanical circulatory support, ventilation, and/or continuous infusion of inotropes and continuous monitoring of left ventricular filling pressures) patient at the time of transplant, due to the increasing demand on the scarce resource of donor organs resulting in an increased waiting time for recipients. Effective prior to 12/1/2020:

Paramount’s Heart Transplant Centers of Excellence Advantage

Adult Pediatric

University Hospitals of Cleveland University of Michigan

Nationwide Children's Hospital Nationwide Children's Hospital

Paramount’s Heart Transplant Centers of Excellence Commercial

Adult Pediatric

University of Cincinnati Health Center Cincinnati Children's Hospital Medical Center

University Hospitals of Cleveland Nationwide Children's Hospital

Paramount’s Heart Transplant Centers of Excellence Elite/ProMedica Medicare Plan

Ohio State Medical Center/Arthur G. James Cancer Center

University of Michigan

Effective 12/1/2020:

Paramount’s Heart Transplant Centers of Excellence Advantage

Adult Pediatric

University Hospitals of Cleveland University of Michigan


Nationwide Children's Hospital

Paramount’s Heart Transplant Centers of Excellence Commercial

Adult Pediatric

University Hospitals of Cleveland UPMC Children’s Hospital of Pittsburgh


Cincinnati Children’s Hospital Medical Center

Paramount’s Heart Transplant Centers of Excellence Elite/ProMedica Medicare Plan


Cleveland Clinic

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Heart-Lung Transplants Combined heart/lung transplantation is intended to prolong survival and improve function in patients with end-stage cardiac and pulmonary diseases. The heart/lung transplantation involves a coordinated triple operative procedure consisting of procurement of a donor heart-lung block, excision of the heart and lungs of the recipient, and implantation of the heart and lungs into the recipient. A heart/lung transplantation refers to the transplantation of one or both lungs and heart from a single cadaver donor. Most heart/lung transplant recipients have Eisenmenger syndrome (37%), followed by idiopathic pulmonary artery hypertension (28%) and cystic fibrosis (14%). Eisenmenger syndrome is a form of congenital heart disease in which systemic-to-pulmonary shunting leads to pulmonary vascular resistance. It is possible that pulmonary hypertension could lead to a reversal of the intracardiac shunting and inadequate peripheral oxygenation or cyanosis. Effective prior to 12/1/2020:

Paramount’s Heart-Lung Transplant Centers of Excellence Advantage

Adult Pediatric

Henry Ford Health System University of Cincinnati Health Center

University Hospitals of Cleveland

Paramount’s Heart-Lung Transplant Centers of Excellence Commercial

Adult Pediatric

Henry Ford Health System University of Cincinnati Health Center


Paramount’s Heart-Lung Transplant Centers of Excellence Elite/ProMedica Medicare Plan

Henry Ford Health System



Paramount’s Heart-Lung Transplant Centers of Excellence Advantage

Adult

No assigned Centers of Excellence No assigned Centers of Excellence

Paramount’s Heart-Lung Transplant Centers of Excellence Commercial

Adult


Paramount’s Heart-Lung Transplant Centers of Excellence Elite/ProMedica Medicare Plan

No assigned Centers of Excellence

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Lung Transplants Lung transplantation may be considered medically necessary for carefully selected patients with irreversible, progressively disabling, end-stage pulmonary disease unresponsive to maximum medical therapy. A lung transplant transforms lives affected by diseases such as:

Alpha-1 antitrypsin deficiency

Bilateral bronchiectasis

Bronchiolitis obliterans

Bronchopulmonary dysplasia

Chronic obstructive pulmonary disease

Cystic fibrosis (both lungs to be transplanted)

Eisenmenger’s syndrome

Emphysema

Eosinophilic granuloma

Idiopathic/interstitial pulmonary fibrosis

Lymphangiomyomatosis

Post inflammatory pulmonary fibrosis

Primary pulmonary hypertension

Pulmonary hypertension due to cardiac disease

Recurrent pulmonary embolism

Sarcoidosis

Scleroderma Prior to the consideration for transplant, patients should be receiving maximal medical therapy including oxygen supplementation or surgical options such as lung-volume reduction surgery for COPD. A lung transplant is surgery to remove an advanced diseased or failing lung and replace it with a healthy lung from another person. The surgery may be done for one lung or for both. It may be considered a useful therapeutic option for carefully selected adults, children and adolescents with irreversible, progressively disabling, primary or secondary end-stage pulmonary disease. Effective prior to 12/1/2020:

Paramount’s Lung Transplant Centers of Excellence Advantage

Adult Pediatric

University of Michigan University of Michigan

Cleveland Clinic University Hospitals of Cleveland

Paramount’s Lung Transplant Centers of Excellence Commercial

Nationwide Children's Hospital Nationwide Children's Hospital



Paramount’s Lung Transplant Centers of Excellence Elite/ProMedica Medicare Plan



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Paramount’s Lung Transplant Centers of Excellence Advantage

Adult Pediatric


Cleveland Clinic University Hospitals of Cleveland

Paramount’s Lung Transplant Centers of Excellence Commercial

Nationwide Children's Hospital UPMC Children’s Hospital of Pittsburgh

University of Michigan Nationwide Children’s Hospital

Paramount’s Lung Transplant Centers of Excellence Elite/ProMedica Medicare Plan


Cleveland Clinic

Kidney Transplants Chronic renal failure is slowly progressive over a number of years and most often results from any disease that causes gradual destruction of the internal structures of the kidneys. It can range from mild dysfunction to severe kidney failure, termed end stage renal disease (ESRD). Kidney transplant, a treatment option for end-stage renal disease (ESRD; chronic irreversible renal-failure), involves the surgical removal of a kidney from a cadaver, living-related donor, or living-unrelated donor and transplantation into the recipient. Patients with ESRD have three options for renal replacement therapy:

hemodialysis;

chronic ambulatory peritoneal dialysis; or

transplantation. Effective prior to 12/1/2020:

Paramount’s Kidney Transplant Centers of Excellence Advantage

Adult Pediatric

Cleveland Clinic University of Michigan

University of Michigan Cleveland Clinic

Paramount’s Kidney Transplant Centers of Excellence Commercial

Adult Pediatric



Nationwide Children's Hospital Cincinnati Children's Hospital Medical Center

Paramount’s Kidney Transplant Centers of Excellence Elite/ProMedica Medicare Plan


University of Cincinnati Health Center

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Paramount’s Kidney Transplant Centers of Excellence Advantage

Adult Pediatric


University of Michigan Cleveland Clinic

Paramount’s Kidney Transplant Centers of Excellence Commercial

Adult Pediatric



UPMC Children’s Hospital of Pittsburgh UPMC Children’s Hospital of Pittsburgh


Paramount’s Kidney Transplant Centers of Excellence Elite/ProMedica Medicare Plan


Cleveland Clinic

Pancreas Transplants Transplantation of a healthy pancreas is a treatment method for patients with insulin-dependent diabetes. Pancreas transplantation occurs in several different scenarios such as:

a history of frequent, acute and severe metabolic complications, such as hypoglycemia, hyperglycemia, or ketoacidosis requiring medical attention;

an insulin-dependent diabetic patient with renal failure who may receive a simultaneous cadaveric pancreas plus kidney transplants;

an insulin-dependent diabetic patient who may receive a cadaveric or living-related pancreas transplant after a kidney transplantation (pancreas after kidney);

a nonuremic diabetic patient with specific severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and labile insulin-dependent diabetes that persists despite optimal medical management may receive a pancreas transplant alone.

Effective prior to 12/1/2020:

Paramount’s Pancreas Transplant Centers of Excellence Advantage

Adult Pediatric


University Hospitals of Cleveland University Hospitals of Cleveland

Paramount’s Pancreas Transplant Centers of Excellence Commercial

Adult Pediatric



Paramount’s Pancreas Transplant Centers of Excellence Elite/ProMedica Medicare Plan




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Paramount’s Pancreas Transplant Centers of Excellence Advantage

Adult Pediatric



Paramount’s Pancreas Transplant Centers of Excellence Commercial

Adult Pediatric



University of Michigan University Hospitals of Cleveland


Paramount’s Pancreas Transplant Centers of Excellence Elite/ProMedica Medicare Plan


Cleveland Clinic

Kidney-Pancreas Transplants Simultaneous pancreas-kidney transplant (SPK), pancreas after kidney transplant (PAK), and living related segmental simultaneous pancreas kidney transplantation, as treatment for diabetic patients with renal disease. Effective prior to 12/1/2020:

Paramount’s Kidney-Pancreas Transplant Centers of Excellence Advantage

Adult Pediatric



Paramount’s Kidney-Pancreas Transplant Centers of Excellence Commercial

Adult Pediatric



Paramount’s Kidney-Pancreas Transplant Centers of Excellence Elite/ProMedica Medicare Plan




Paramount’s Kidney-Pancreas Transplant Centers of Excellence Advantage

Adult Pediatric



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Paramount’s Kidney-Pancreas Transplant Centers of Excellence Commercial

Adult Pediatric



Paramount’s Kidney-Pancreas Transplant Centers of Excellence Elite/ProMedica Medicare Plan


Cleveland Clinic

Liver Transplants Liver transplantation (either from cadaver liver or living donor) has become the treatment of last resort for selected patients whose chronic or acute liver disease is progressive, life threatening, and unresponsive to medical therapy. Liver transplantation may be performed with liver donation after brain, circulatory or cardiac death, or with a liver segment donation from a living donor. A liver transplant, using a cadaver or living donor, may be medically necessary for patients with irreversible, end-stage liver failure due to conditions that include, but are not limited to, the following: A. Cholestatic Liver Diseases

Biliary atresia

Familial cholestatic syndromes

Primary biliary cirrhosis

Secondary biliary cirrhosis

Primary sclerosing cholangitis

Secondary sclerosing cholangitis when the primary etiology is resolved

Alagille syndrome

Nonsyndromic paucity of the intrahepatic bile ducts

Cystic fibrosis B. Hepatocellular disease

Alcoholic cirrhosis

Viral hepatitis (including A, B, C, or non-A, non-B)

Autoimmune hepatitis

Cryptogenic cirrhosis

Alpha-1 antitrypsin deficiency

Hemochromatosis

Protoporphyria

Wilson's disease

Non-alcoholic steatohepatitis C. Malignancies such as the following:

Polycystic disease of the liver in patients who have massive hepatomegaly causing obstruction or functional impairment

Familial amyloid polyneuropathy (Corino de Andrade's disease, paramyloidosis)

Amyloidosis

Disorders of branch chain amino acids (e.g., Maple syrup urine disease (MSUD), branched chain a-ketoacid dehydrogenase (BCKD)

Fulminant hepatitic failure

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Glycogen storage disease type IV

Hyperoxaluria

Steatohepatitis

Tyrosinemia

Urea cycle defects Contraindications Potential contraindications for solid organ transplant are subject to the judgment of the transplant center include the following, not all-inclusive:

• Known current malignancy, including metastatic cancer • Recent malignancy with high-risk of recurrence • Untreated systemic infection making immunosuppression unsafe, including chronic infection • Severe end stage organ damage including but not limited to: Severe diabetes mellitus with end

organ damage, irreversible severe pulmonary disease, with FEV1 < 1 L or FVC < 50%, irreversible severe hepatic disease, irreversible severe renal disease

• Significant irreversible life-limiting/end-stage diseases/medical conditions • History of cancer with a moderate risk of recurrence

Advanced ilieo-femoral vascular disease • Systemic disease that could be exacerbated by immunosuppression • Psychosocial conditions or chemical dependency affecting the ability to adhere to therapy.

Active drug, substance, or alcohol abuse within the last 6 months

Human immunodeficiency virus (HIV) disease unless ALL of the following are met: − CD4 count greater than 200 cells/mm3 − Undetectable HIV-1 ribonucleic acid (RNA) − Stable anti-retroviral therapy for > than three months − Absence of serious complications associated with or secondary to HIV disease (e.g., opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections; Kaposi’s sarcoma; or other neoplasm)


Paramount’s Liver Transplant Centers of Excellence Advantage

Adult Pediatric




Paramount’s Liver Transplant Centers of Excellence Commercial

Adult Pediatric

Cincinnati Children's Hospital Medical Center Cincinnati Children's Hospital Medical Center


Cleveland Clinic

Paramount’s Liver Transplant Centers of Excellence Elite/ProMedica Medicare Plan



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Paramount’s Liver Transplant Centers of Excellence Advantage

Adult Pediatric




Paramount’s Liver Transplant Centers of Excellence Commercial

Adult Pediatric

Cincinnati Children's Hospital Medical Center UPMC Children’s Hospital of Pittsburgh


Cincinnati Children's Hospital Medical Center

Paramount’s Liver Transplant Centers of Excellence Elite/ProMedica Medicare Plan


Cleveland Clinic

Intestine Transplant Intestinal failure 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 balance. Some conditions are more closely associated with pediatric intestinal failure while others are more common with intestinal failure in adults. The following are pediatric conditions causing intestinal failure:

Short bowel syndrome following extensive bowel surgeries (midgut volvulus)

Congenital malformations (e.g. intestinal atresia, gastroschisis, aganglionosis)

Absorptive impairment (e.g. microvillus involution disease, chronic intestinal pseudo-obstruction)

Infections of gastrointestinal tract (e.g. necrotizing enterocolitis) The following are adult conditions causing intestinal failure:

Crohn’s disease

Tumors of the mesenteric root and retroperitoneum (e.g. desmoid tumor)

Short bowel syndrome following extensive surgeries secondary to mesenteric ischemia (following thrombosis,

embolism, volvulus or trauma)

Chronic intestinal pseudo-obstruction

Small bowel tumors such as Gardner’s Syndrome (familial colorectal polyposis) Impending or overt liver failure due to total parenteral nutrition (TPN)-induced liver injury. Progressive thrombocytopenia and cholestasis are the most reliable indicators of developing liver dysfunction. Complications of portal hypertension such as variceal bleeding, ascites, and hepatorenal syndrome do not arise until late in the

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course of disease. Timely referral may allow salvage of the native liver with the more accessible intestinal allograft. Given the higher patient survival rates with this single-organ transplant, patients should be identified and considered for transplant before development of irreversible liver dysfunction Small Bowel Transplant: The purpose of a small bowel (SB) transplant is to restore bowel function and allow for adequate nutrition in patients with short bowel syndrome (SBS). It may be an alternative to total parenteral nutrition (TPN) for selected patients who are predicted to have poor survival on TPN. Multivisceral Transplant: Candidates for multivisceral (MV) transplant have short bowel syndrome and terminal liver failure or other gastrointestinal problems such as pancreatic failure, thromboses of the celiac axis and the mesenteric artery or pseudo obstruction affecting the entire gastrointestinal tract. Due to anatomic or other medical problems, this group of patients requires a more extensive transplant procedure than a small bowel and liver. MV transplantation may include in addition to the small bowel and liver, stomach, duodenum, jejunum, ileum, pancreas and/or colon. A small bowel transplant may be performed as an isolated procedure or in conjunction with other visceral organs, including the liver, duodenum, jejunum, ileum, pancreas or colon. Isolated small bowel transplant is commonly performed in patients with short bowel syndrome. An isolated small bowel (intestinal) transplant has evolved into an established therapeutic modality in the management of the patient with irreversible intestinal failure. It is performed mainly in patients with short bowel syndrome (SBS) and those who develop severe complications due to total parenteral nutrition (TPN). Short bowel syndrome is 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. The goal of transplantation is to provide a treatment option that is to eliminate the need for TPN and to reverse or prevent TPN associated liver disease.

A small bowel transplant using cadaveric intestine may be considered MEDICALLY NECESSARY in adult and pediatric patients with intestinal failure (characterized by loss of absorption and the inability to maintain protein energy, fluid, electrolyte or micronutrient balance), who have established long-term dependency on total parenteral nutrition (TPN) and are developing or have developed severe complications due to TPN.

A small bowel transplant using a living donor may be considered MEDICALLY NECESSARY only when a cadaveric intestine is not available for transplantation in a patient who meets the criteria noted above for a cadaveric intestinal transplant.

A small bowel retransplant may be considered MEDICALLY NECESSARY after a failed primary small bowel transplant.

A small bowel transplant using living donors is considered NOT MEDICALLY NECESSARY in all other situations.

A small bowel transplant is investigational and /or unproven and therefore considered NOT MEDICALLY NECESSARY for adults and pediatric patients with intestinal failure who are able to tolerate TPN.

Contraindications Potential contraindications for a small bowel transplant are subject to the judgment of the transplant center include the following, not all-inclusive:

Known current malignancy, including metastatic cancer

Recent malignancy with high risk of recurrence

Untreated systemic infection making immunosuppression unsafe, including chronic infection

Other irreversible end-stage disease not attributed to intestinal failure

History of cancer with a moderate risk of recurrence

Systemic disease that could be exacerbated by immunosuppression

Psychosocial conditions or chemical dependency affecting ability to adhere to therapy

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Paramount’s Intestine Transplant Centers of Excellence Advantage

Adult Pediatric

UPMC Children's Hospital of Pittsburgh UPMC Children's Hospital of Pittsburgh

Henry Ford Health System Cleveland Clinic


Paramount’s Intestine Transplant Centers of Excellence Commercial

Adult Pediatric

University of Cincinnati Health Center UPMC Children's Hospital of Pittsburgh

Henry Ford Health System Cleveland Clinic

Paramount’s Intestine Transplant Centers of Excellence Elite/ProMedica Medicare Plan


Henry Ford Health System


Paramount’s Intestine Transplant Centers of Excellence Advantage

Adult Pediatric


Paramount’s Intestine Transplant Centers of Excellence Commercial

Adult Pediatric

Cleveland Clinic Cleveland Clinic

Paramount’s Intestine Transplant Centers of Excellence Elite/ProMedica Medicare Plan

No assigned Centers of Excellence

Bone Marrow Transplant Allogeneic bone marrow transplants or blood stem cell support (myeloablative or non-myeloablative) associated with high dose chemotherapy for:

Acute lymphocytic leukemia;

Chronic myelogenous leukemia;

Severe combined immunodeficiency disease;

Wiskott-Aldrich syndrome;

Aplastic anemia;

Acute myelogenous leukemia.

Sickle Cell Anemia;

Non-relapsed or relapsed non-Hodgkin’s Lymphoma;

Multiple Myeloma;

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Myelodysplastic syndromes associated with intermediate, high or very high revised international prognostic scoring system (IPSS-R) scores

Autologous bone marrow transplants or blood stem cell support associated with high dose chemotherapy for the following:

Acute leukemias;

Non-Hodgkin’s Lymphoma;

Hodgkin’s Disease;

Burkitt’s Lymphoma;

Neuroblastoma.

Multiple myeloma;

Chronic myelogenous leukemia;

Nonrelapsed non-Hodgkin’s lymphoma.

Immunoglobulin light chain (AL) amyloidosis

Testicular cancer Autologous bone marrow or stem cell transplant refers to harvesting the bone marrow or stem cells from the patient and storing it for future use. The patient undergoes treatment including tumor ablation with high-dose chemotherapy and/or radiation. After the treatment, the bone marrow or stem cells are reinfused (transplanted) into the patient. Allogeneic bone marrow or stem cell transplant refers to harvesting the bone marrow or stem cells from a related or unrelated donor and storing it for future use. The patient undergoes treatment including tumor ablation with high-dose chemotherapy and/or radiation. After the treatment, the bone marrow or stem cells are reinfused (transplanted) into the patient. Effective prior to 12/1/2020:

Paramount’s Bone Marrow Transplant Centers of Excellence Advantage

Adult Pediatric



Nationwide Children’s Hospital

Paramount’s Bone Marrow Transplant Centers of Excellence Commercial

Adult Pediatric

University of Michigan Nationwide Children’s Hospital


University Hospitals of Cleveland Cincinnati Children’s Hospital Medical Center


UPMC Children’s Hospital of Pittsburgh

Paramount’s Bone Marrow Transplant Centers of Excellence Elite/ProMedica Medicare Plan



PG0461 – 12012020


Adult Pediatric



Nationwide Children’s Hospital Nationwide Children’s Hospital

Paramount’s Bone Marrow Transplant Centers of Excellence Commercial

Adult Pediatric

Henry Ford Health System Henry Ford Health System

UPMC Children’s Hospital of Pittsburgh UPMC Children’s Hospital of Pittsburgh

Paramount’s Bone Marrow Transplant Centers of Excellence Elite/ProMedica Medicare Plan


Cleveland Clinic

Additional Transplants

When No Transplant Centers of Excellence are Identified:

Transplant Evaluation: Prior Authorization is required.

Transplant Procedure: Prior Authorization is required.

Including, not all-inclusive:

Donor Leukocyte Infusion Transplants Donor lymphocyte infusion is a type of therapy in which lymphocytes from the blood of a donor are given to a patient who has already received a stem cell transplant from the same donor with the attempt to induce a beneficial graft-versus-tumor response. The donor lymphocytes may kill remaining cancer cells. Donor lymphocyte infusion is being studied in the treatment of many types of cancer and is covered for patients with most hematologic malignancies who relapse after a prior covered marrow-ablative allogeneic stem cell transplant.

Corneal Transplants Corneal transplants are outside the scope of this policy. Corneal transplants are covered without prior evaluation notification or authorization. A prior authorization is required for the transplant surgical procedure. Non-covered Transplants The following are not covered because they are considered experimental/investigational, not all-inclusive:

Hand transplants

Face transplants

Uterine transplants CODING/BILLING INFORMATION The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered.

PG0461 – 12012020

CPT CODES

32851 Lung transplant, single; without cardiopulmonary bypass

32852 Lung transplant, single; with cardiopulmonary bypass

32853 Lung transplant, double ( bilateral sequential or en bloc) ; without cardiopulmonary bypass

32854 Lung transplant, double ( bilateral sequential or en bloc) ; with cardiopulmonary bypass

33935 Heart-lung transplant with recipient cardiectomy-pneumonectomy

33945 Heart transplant, with or without recipient cardiectomy

38240 Hematopoietic progenitor cell (HPC) allogeneic transplantation per donor

38241 Hematopoietic progenitor cell (HPC) autologous transplantation

44135 Intestinal allotransplantation; from cadaver donor

44136 Intestinal allotransplantation; from living donor

47135 Liver allotransplantation, orthotopic, partial or whole, from cadaver or living donor, any age

48554 Transplantation of pancreatic allograft

50360 Renal allotransplantation, implantation of graft; without recipient nephrectomy

50365 Renal allotransplantation, implantation of graft; with recipient nephrectomy

ICD-10-CM CODES

Z76.82 Awaiting organ transplant status

Z94.0 Kidney transplant status

Z94.1 Heart transplant status

Z94.2 Lung transplant status

Z94.3 Heart and lungs transplant status

Z94.4 Liver transplant status

Z94.5 Skin transplant status

Z94.6 Bone transplant status

Z94.7 Corneal transplant status

Z94.81 Bone marrow transplant status

Z94.82 Intestine transplant status

Z94.83 Pancreas transplant status

Z94.84 Stem cells transplant status

Z94.89 Other transplanted organ and tissue status

Z94.9 Transplanted organ and tissue status, unspecified

REVISION HISTORY EXPLANATION ORIGINAL EFFECTIVE DATE: 02/01/20 09/22/20: Updated clarification verbiage r/t COE - Transplant Center of Excellence (COE) is any health care provider, group or association of health care providers designated by Paramount to provide services, supplies or drugs for the specified transplant performed on a covered person. Paramount’s COEs are determined by volume of transplants completed, patient survival rate, donor-to-transplant access, and contracted cost metrics. COEs are specific to each organ, product line and adult/pediatric. All COE determinations and metrics will be evaluated annually. Transplant programs that have not been designated as a COE may request reconsideration at any time. All reconsiderations should be requested in writing and directed to the following address: Paramount Director, Utilization Management 1901 Indian Wood Circle Maumee, OH 43537 10/21/20: Added that the prior authorization request is required from either the ordering/referring provider or the facility once the transplant evaluation is approved, including the requested procedure codes. Revised the assigned Center’s of Excellence, prioritizing those providers that are Par-Providers with Paramount Healthcare.

PG0461 – 12012020

Stressed/documented within the ‘green box’ that the Elite product (along with all the product lines) always requires a prior authorization for Non Participating Providers 12/01/20: Added the Transplant CPT codes to the medical policy. Placed the medical policy on the new Paramount formatted template. Added coverage to indicate Elite/ProMedica Medicare Plan. Designated the SCOPE of the medical policy applies to both professional and facility services. Improved the verbiage related to Advantage PA requirement from the term ‘constructs’ to the terms ‘requirements’ and ‘means’. REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Ohio Department of Medicaid American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets Industry Standard Review Hayes, Inc. Organ Procurement and Transplantation Network (OPTN). Organ Procurement and Transplantation Network Policies. 2018; https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf Accessed October 2019 Scientific Registry of Transplant Recipients, https://www.srtr.org/transplant-centers/?query=&distance=50&location=&state=OH&recipientType=adult&organ=liver&sort=transplantRate OPTUM® Transplant Review Guidelines



Documents

MEDICAL POLICY Transplant Prior Authorization …...A heart transplant is the last resort for persons with end-stage cardiac disease where all other treatments have failed. Causes