Coverage Policies

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Effective Date: 08/29/2006 Title: Alpha 1-Antitrypsin Inhibitor Therapy
Revision Date: 05/01/2018 Document: BI173:00
CPT Code(s): J0256, J3491 and S9346
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

The use of alpha 1 antitrypsin inhibitors (Aralast, Prolastin, and Zemira) is an important part of the treatment of emphysema in selected circumstances. It is covered, but subject to preauthorization in accordance with medical criteria.

Medical Statement

Alpha 1-antitrypsin inhibitor therapy (e.g., Prolastin, Aralast, and Zemira) is considered medically necessary for selected members with emphysema due to alpha 1-antitrypsin deficiency when all of the following criteria are met:

  1. Member is a non-smoker or an ex-smoker (at least 6 months) (Z87.891); and
  2. Member has PiZZ, PiZ (null) or Pi (null, null) phenotype (homozygous) alpha 1-antitrypsin deficiency (E88.01) or other phenotypes associated with serum alpha 1-antitrypsin concentrations of less than 80 mg per deciliter (mg/dL). (Alpha1-antitrypsin inhibitor is considered not medically necessary for use in individuals with the PiMZ or PiMS phenotypes of alpha 1-antitrypsin deficiency because these individuals appear to be at small risk of developing pan acinar emphysema); and
  3. Member has a low serum concentration of alpha 1-antitrypsin (AAT) less than 80 mg/dL or less than 11 uM/L or less than 0.8 g/L (35% of normal); and
  4. Member has progressive pan acinar emphysema (J43.1) with a documented rate of decline in forced expiratory volume in 1 second (FEV1) of greater than 50cc per year.

Repeat doses of alpha 1-antitrypsin inhibitor therapy are considered medically necessary for members who met the requirements for alpha 1-antitrypsin inhibitor at therapy initiation and who demonstrate a substantial reduction in rate of deterioration of lung function.

Codes Used In This BI:

J0256             Inj: alpha 1-proteinase inhibitor – human, 10 mg (Prolastin, Zemira, Aralast)

S9346            Home infusion: alpha 1-proteinase inhibitor (e.g. Prolastin)


Because pan acinar emphysema does not develop in some individuals who have alpha 1-antitrypsin deficiency, replacement therapy with alpha 1-antitrypsin inhibitor is of no proven value in affected individuals without clinical evidence of emphysema and is therefore considered experimental and investigational for these individuals.

If the patient starts or resumes smoking, this benefit will end.


1.     Miravitlles M, Vidal R, Torrella M, et al. Evaluation of replacement therapy in emphysema caused by alpha 1-antitrypsin deficiency. Arch Bronconeumol. 1994; 30(10):479-484.

2.     Seersholm N, Wencker M, Banik N, et al. Does alpha1-antitrypsin augmentation therapy slow the annual decline in FEV1 in patients with severe hereditary alpha1-antitrypsin deficiency? Wissenschaftliche Arbeitsgemeinschaft zur Therapie von Lungenerkrankungen (WATL) alpha1-AT study group. Eur Respir J. 1997; 10(10):2260-2263.

3.     Hutchison DC, Hughes MD. Alpha-1-antitrypsin replacement therapy: Will its efficacy ever be proved? Eur Respir J. 1997; 10(10):2191-2193.

4.     Pierce JA. Alpha1-antitrypsin augmentation therapy. Chest. 1997; 112(4):872-874.

5.     Coakley RJ, Taggart C, O`Neill S, et al. Alpha1-antitrypsin deficiency: Biological answers to clinical questions. Am J Med Sci. 2001; 321(1):33-41.

6.     Product inserts/aralast_pi.pdf. Accessed: August 22, 2003.

7.     Aventis Behring LLC. Zemaira. Alpha1-Proteinase Inhibitor (Human). Prescribing Information. 19131-01. Kankakee, IL: Aventis; July 2003. Available at: .

8.     Bayer Corporation Pharmaceutical Division. Prolastin. Alpha1-Proteinase Inhibitor (Human). Package Insert. 14-7601-001. Elkhart, IN: Bayer; revised January 2002. Available at: .

9.     U.S. Pharmacopeial Convention. USP DI Volume I: Drug Information for the Healthcare Professional. Greenwood Village, CO: Micromedex, Inc.; 2003.

10. Parfrey H, Mahadeva R, Lomas DA. Alpha(1)-antitrypsin deficiency, liver disease and emphysema. Int J Biochem Cell Biol. 2003;35(7):1009-1014.

11. Shah P, Ohlsson A. Alpha-1 proteinase inhibitor (a1PI) for preventing chronic lung disease in preterm infants. Cochrane Database Syst Rev. 2001;(3):CD002775.

12. Juvelekian GS, Stoller JK. Augmentation therapy for alpha(1)-antitrypsin deficiency. Drugs. 2004;64(16):1743-1756.

13. Abboud RT, Ford GT, Chapman KR. Emphysema in alpha1-antitrypsin deficiency: Does replacement therapy affect outcome? Treat Respir Med. 2005;4(1):1-8.

14. Aetna Clinical Policy Bulletins; Alpha 1-Antitrypsin Inhibitor Therapy At:

15. Arkansas BlueCross BlueShield Coverage Policy Manual; Alpha I Globulin Antitrypsin Replacement Therapy (Prolastin) at:


Effective 01/01/2017: Replaced HCPCS code J3491 with J3490 under the Claim Statement section.  J3491 is not a valid code.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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