AMERICAN ASSOCIATION FOR HOMECARE Via Hand Delivery January 19, 2007 Leslie V. Norwalk, Esq. Acting Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Room 445-G, Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 http://www.cms.hhs.gov/eRulemaking Re: National Coverage Analysis for Nebulized Beta Adrenergic Therapy for Lung Diseases (CAG - 00354N) Dear Ms. Norwalk: The American Association for Homecare (AAHomecare) submits the following comments on the Centers for Medicare and Medicaid Services' (CMS') national coverage analysis (NCA) for nebulized beta adrenergic agonist therapy for lung disease. AAHomecare is the only national association representing every line of service within the homecare community. AAHomecare members include home health agencies and suppliers and manufacturers of DME, prosthetics, orthotics, and supplies (collectively "DMEPOS"), rehab and assistive technologies, and pharmacies that provide infusion and inhalation drug therapies to patients in their homes. Our membership reflects a cross-section of the homecare community, including national, regional, and local providers and suppliers. AAHomecare and its members are committed to advancing the value and practice of quality health care services at home. I. BACKGROUND As you are aware, coverage for outpatient drugs under Medicare Part B is limited to a very small number of drugs. With respect to respiratory medications, Medicare covered inhalation drugs used with a nebulizer under the premise that the drug was a supply necessary to accomplish the l therapeutic objective of the nebulizer. Medicare pays for the nebulizer, the drug, and any necessary supplies. Inhalation drugs differ significantly from other outpatient drugs that are self- administered because they require an array of professional and administrative services, including delivery, education, oversight, and monitoring to ensure that the drug therapy is administered safely and effectively in the home. In March 2006, the program safeguard contractors (PSCs) for the durable medical equipment regional contractors (DMERCs) initiated a revision to the local coverage determination (LCD) for nebulizers. The revised LCD would make payment and coverage changes for a number of respiratory drugs including levalbuterol. Specifically, the PSCs proposed that Medicare should pay no more for levalbuterol than the allowance established for albuterol. Before the DMERC PSCs published a final nebulizer LCD, CMS published the above referenced NCA, requesting public comments on the use of nebulized beta adrenergic agonist therapy for individuals with lung disease generally, and in particular, the use of levalbuterol in the Medicare population with chronic obstructive pulmonary disease (COPD). AAHomecare members with clinical expertise in respiratory care reviewed the relevant science and concluded that the studies, as a whole, demonstrate that the use of nebulized beta agonists, including levalbuterol, is both reasonable and necessary for use in the treatment of individuals with COPD. Finally, given the potential that a final nebulizer LCD, if issued prematurely, could conflict with a national coverage determination (NCD), the LCD should be withdrawn, or at least held in abeyance pending the issuance of an NCD by CMS. II. COMMENTS A. Chronic Obstructive Pulmonary Disease is a Chronic, Progressive and Debilitating Disease 2 COPD is the leading cause of morbidity and mortality worldwide. Approximately 15 million Americans have been diagnosed with COPD, and an estimated 15 million more have undiagnosed COPD. COPD costs the U.S. economy over $18 billion a year in direct medical costs and an 3 estimated $11 billion in indirect costs. COPD is responsible for a significant part of all physician office visits and emergency room (ER) visits and ranks number three (3) in acute hospital admissions among Medicare aged persons. Based on 2001 data from Medicare, more than 397,000 patients were discharged from acute care hospitals with a diagnosis of COPD. The average length of stay for a COPD admission is 5.1 days at the rate of $4,000 per day. Medicare payments to hospitals for routine COPD admissions alone exceed $1.5 billion. COPD includes chronic bronchitis and emphysema and has been defined recently as the physiologic finding of nonreversible pulmonary function impairment.4 COPD is the fourth leading cause of death in the world and the only leading cause of death for which both prevalence and mortality are rising.5 COPD is a disease characterized by severe airflow limitation resulting from chronic inflammation of the airways, decrease in functional lung tissue and the dysfunction of pulmonary blood vessels. The airflow limitation is progressive. The clinical course of COPD is characterized by chronic disability with intermittent acute exacerbations that occur more often during the winter months. The World Health Organization has projected that COPD will rank fifth in 2020 as a global burden of disease.6 B. Bronchodilator drugs are central to the management of COPD The principal action of beta agonist drugs is to relax the smooth muscle of the airways by stimulating the beta2-adrenergic receptors, which increases the cyclic AMP and produces functional antagonism to bronchoconstriction. These drugs have a very rapid onset and relatively long half-life, ranging from 4 to 12 hours depending on the formulation. There is an abundance of scientific evidence supporting combination bronchodilator therapy in COPD. The most common and effective combination therapy is a beta agonist used in conjunction with an anticholinergic (i.e., albuterol and ipratropium bromide) 7,8 An effective care plan for the treatment of COPD included effective management of stable COPD and the ability to manage exacerbations. Goals for effective disease management include but are not limited to: relieve symptoms, prevent disease progression, prevent and treat complications and prevent and treat exacerbations. Central to achieving these COPD management goals are appropriate and efficacious inhaled drug therapies. As stated in the Global Initiative for Chronic Lung Disease (GOLD) standards, bronchodilator medications are central to symptom management in COPD.9 Additionally the GOLD standards state: • Inhaled bronchodilator therapy is preferred. • The choice between beta-agonist, anticholinergic, theophylline or combination therapy depends on the individual response in terms of symptom relief and side effects. • Combining bronchodilators may improve efficacy and decrease the risk of side effects compared to simply increasing the dose of a single bronchodilator. Growing scientific data suggest the introduction of newer, long-acting beta-agonist bronchodilator drugs used in conjunction with inhaled glucocorticosteroids and short-acting beta- agonist bronchodilator drugs provides for highly effective control and symptom management of patients with stable COPD. Medicare payments for inhalation drugs, particularly the beta adrenergic agonists (beta agonists), have grown steadily over the last decade. This growth in utilization and spending is not surprising given the demographics and epidemiology of this disease. While inhalation drugs do not specifically cure COPD, they can effectively manage its core symptoms in the outpatient/home setting and substantially reduce the need for more expensive and comprehensive medical interventions requiring ER visits and acute hospital admissions. C. Comments Regarding Specific Formulation of Bronchodilator Drugs Standard, racemic albuterol is a stereoisomer composed of a 50:50 ratio of (R) and (S) isomers. The (R) isomer is the therapeutically active bronchodilator. The (S) isomer has no bronchodilatory effect and is now believed to be paradoxical, actually opposing bronchodilation. A single isomer (R-isomer) version of albuterol, known as levalbuterol, has been FDA-approved and has been commercially available for a number of years. Levalbuterol is a safe and effective beta agonist, yet there remains only limited published evidence demonstrating levalbuterol to be more effective then racemic albuterol in COPD. In a retrospective review, Truitt, Witko and Halpern10 compared the efficacy and outcomes in patients hospitalized with chronic obstructive pulmonary disease (COPD) or asthma. In this study, 125 patients were treated with nebulized racemic albuterol and 109 patients were treated with levalbuterol and concluded that "compared with patients treated with racemic albuterol, those treated with levalbuterol required less medication, had shorter lengths of hospital stay, had decreased costs for nebulizer therapy and hospitalization, and appear to have a more prolonged therapeutic benefit. 11 Nelson, Bensch, Pleskow, et al. compared levalbuterol vs racemic albuterol and the effects on bronchodilation in a randomized, double-blinded group of 362 patients with asthma. They noted significant improvement in FEV1 with levalbuterol and concluded "levalbuterol appears to provide a better therapeutic index than the standard dose of racemic albuterol. These results support the concept that the (S)-albuterol may have detrimental effects on pulmonary function." 12 Schreck and Babin appearing in the American Journal of Emergency Medicine in 2005, compared emergency department (ED) admission rates of patients presenting with acute asthma who were treated with either racemic albuterol or levalbuterol. The article concluded "Levalbuterol treatment in the emergency department