National Coverage Analysis (NCA) Tracking Sheet

Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases

CAG-00354N

Issue

Lung diseases such as chronic obstructive pulmonary disease (COPD) and asthma are characterized by airflow limitation that may be partially or completely reversible. Pharmacologic treatment with bronchodilators is used to prevent and/or control daily symptoms that may cause disability for persons with these diseases. These medications are intended to improve the movement of air into and from the lungs by relaxing and dilating the bronchial passageways. Beta adrenergic agonists are a commonly prescribed class of bronchodilator drug. They can be administered via nebulizer, metered dose inhaler, orally, or dry powdered inhaler.

Nebulized beta adrenergic agonist therapy with racemic albuterol has been used for many years. More recently levalbuterol, the (R) enantiomer of racemic albuterol, has been used in some patient populations. CMS has become aware of concerns regarding the appropriate use of nebulized beta adrenergic agonist therapy for lung diseases.

CMS has internally generated a formal request for a National Coverage Analysis to determine when treatment with a nebulized beta adrenergic agonist is reasonable and necessary for Medicare beneficiaries with COPD.

Benefit Category

Durable Medical Equipment

Requestor Information

Requestor Name Requestor Letter
Internally generated request N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
12/20/2006
Expected NCA Completion Date
09/18/2007
Public Comment Period
12/20/2006 - 01/24/2007
Proposed Decision Memo Due Date
Proposed Decision Memo Released
06/20/2007
Proposed Decision Memo Public Comment Period
06/20/2007 - 07/20/2007
Decision Memo Released
09/10/2007
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Francina Spencer
Lead Medical Officers
Tiffany Sanders, MD

Medicare Benefit Category Determination Date

Actions Taken

December 20, 2006

CMS initiates an NCA on the use of nebulized levalbuterol for the treatment of COPD in the Medicare population. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days. CMS considers all public comments, and is particularly interested in clinical studies and other scientific information relevant to the technology under review.

You may submit comments by clicking on the orange "Comment" button located at the top of the page.

January 22, 2007

Due to technical difficulties, CMS extends the comment period to January 24

May 31, 2007

Posted comments  received. [PDF, 739KB]

View comments  received through the website.

June 20, 2007

Posted Proposed Decision Memorandum. We invite comments on the Proposed Decision Memorandum.

(View Comments [PDF, 17MB]

September 10, 2007

Final Decision Memorandum posted.