Solid Organ Transplant: Lung(Eff. beginning 1.1.24) Form

Clinical Guideline Coverage Criteria

The Plan uses guidance from the Centers for Medicare and Medicaid Services (CMS) and MassHealth for coverage determinations for its Dual Product Eligible plan Members. MassHealth Medical Necessity Determinations and CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs) and documentation included in the Medicare manuals are the basis for coverage determinations where available.

For Tuft’s Health One Care plan Members the following criteria is used:

• MassHealth Medical Necessity Determinations for Organ Transplant Procedures

Indications for lung transplant include pulmonary disease such as, but not limited to the following:

• alpha-1-antitrypsin deficiency,
• advanced obstructive lung disease,
• pulmonary hypertension,
• Bronchopulmonary dysplasia,
• cystic fibrosis,
• interstitial lung disease (ILD),
• Lymphangioleiomyomatosis,
• sarcoidosis,
• Eisenmenger’s syndrome, and
• severe bronchiectasis.

In general, transplant recipients over the age of 70 years have an increased likelihood for poor outcome and worse long-term survival compared to younger recipients.

Special Considerations:

• The Plan will consider the following types of transplants for the circumstances and/or diagnoses listed below:

Single Lung Transplantation:

Appropriate for all indications except as specified in Bilateral transplantation and Heart-Lung Transplant

Bilateral Lung Transplantation:

• Mandatory for generalized bronchiectasis
• Mandatory for end stage Cystic Fibrosis disease
• Suitable for other forms of respiratory failure not complicated by severe left ventricular cardiac dysfunction (seeHeart-Lung indications)

Heart-Lung Transplantation:

• Eisenmenger syndrome with a surgically uncorrectable anomaly and irreversible pulmonary hypertension
• Pulmonary disease with severe left ventricular failure (NOTE: A pulmonary diagnosis with severe right heart failure is not an indication for a heart-lung transplant unless accompanied by severe left ventricular failure)

Living Lobar Lung Transplant:

May be authorized in children or small adults only and generally only for cystic fibrosis. May be authorized in cases where it is clear a Member will not live long enough to receive a cadaveric transplant Will not be authorized in cases where the patient is in extremis (emergency situations)

Limitations

The Plan will not authorize the coverage of a lung transplant for Member meeting ONE of the following:

1. Active inhaled substance use (e.g., smoking cigarettes, smoking marijuana, inhaling e-cigarettes, vaping)
2. Active or uncontrolled alcohol use disorder or substance use disorder
3. Acute illness or clinically unstable
4. Active Hepatitis C disease
5. Any unresolved psychosocial concerns or history of noncompliance with and/or medical management
6. Acute coronary syndrome or myocardial infarction within 30 days (excluding demand ischemia)
7. Hepatitis B sAg+

8. Human immunodeficiency virus (HIV) infection unless ALL of the following are met:
   • CD4 count greater than 200 cells/mm3 for > 3 months prior to transplantation; and
   • Undetectable HIV-1 ribonucleic acid (RNA); and
   • Stable anti-retroviral therapy for > 3 months; and
   • 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)
9. Malignancy with high risk of recurrence or death
10. Significant Coronary Artery Disease or Right or Left Ventricular Dysfunction
11. Significant dysfunction of the liver, kidney, or central nervous system
12. Stroke within 30 days or progressive cognitive impairment
13. Uncontrolled or untreatable infection, any source
14. Ventilator dependent and actively treated for acute respiratory failure (Chronic ventilator dependency is not a contraindication)
15. Other severe uncontrolled medical condition expected to limit survival after transplant

Solid Organ Transplant: Lung

Codes