Funding Focus

Nebulizer Med Coverage Forces Respiratory Providers to Hurdle

• By Kelly Riley
• Jan 01, 2008

Medicare has repeatedly changed the coverage guidelines for aerosolized medications, and did so again July 1, 2007. Gone are codes that once differentiated albuterol and levabuterol. Those codes have been replaced with one code for both drugs — described as “Albuterol all formations” — Q4094 for the unit dose and Q4093 for the concentrated version.

Earlier in 2007, the Centers for Medicare & Medicaid Services (CMS) also revised policy to deny coverage for compounded inhalation solutions on the basis that they are medically unnecessary. The change took effect July 1.

Shortly thereafter, in the decision memo for Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases (CAG-00354N) released Sept. 10, 2007, CMS stated in part, "examination of the published medical evidence does not provide sufficient information that would enable CMS to define specific populations of patients who would benefit from a particular treatment with particular medications at this time." CMS also announced that there would be no national coverage determination (NCD) established. Instead, a local coverage determination process (LCD) or case-by-case adjudication will be used to make those decisions. Whether or not there is an NCD, however, there is still coverage for this treatment modality under current statute and regulations.

Those of us who take care of patients with COPD and asthma see the role of beta-agonists as a standard part of care and management. The regimen is clearly delineated in the G.O.L.D. Standards, which just received a complete overhaul. What is missing is conclusive data that defines exact drugs, doses and combination therapies, including short-acting versus long-acting, when to combine with anticholinergics or corticosteroids, and that those combinations improve long-term lung function and mortality. To establish an NCD, Medicare wants to see more than the subjective improvements, such as the decrease in dyspnea and increase in ability to perform ADLs. CMS of late has become a data-driven, show-me-the-science payor.

Where does that leave those actually in the practice of prescribing, dispensing and educating? A place to start might be to ensure that what we as practitioners agree to support and utilize is backed by solid scientific evidence.

With CMS combining albuterol and Xopenex under the auspices of one code, and Xopenex costing up to three times more than albuterol, our response should be calculated. Perhaps the answer is to recommend the more expensive option only to patients to whom it is indisputable — the clinical outcomes warrant the cost. For patients in which daily use of albuterol, Xopenex or other short-acting beta-agonists (SABAs) has not proved effective, CMS has at least approved new policy and payment for long-acting beta-adrenergic agonists (LABAs). This approval occurred following FDA approval for Arformoterol (Brovana) in October 2006 and Formoterol (Performist) May 11, 2007.

The coverage criteria differ depending on what SABA is used:
1.    It is medically necessary for the management of chronic obstructive pulmonary disease (ICD-9 diagnosis codes 491.0-492.8, 496); and,
2.    The patient has a documented history of routine use of at least four doses per day of an FDA-approved albuterol or metaproterenol inhalation solution or at least three doses per day of an FDA-approved levalbuterol inhalation solution.

If these criteria are not met, Formoterol and Arformoterol will be denied. The policy includes a statement as to the quantity limits, where a maximum of two vials of Formoterol (20 micrograms each) or two vials of Arformoterol (15 micrograms each) are covered per day. SABAs may be covered as rescue/supplemental medication in addition to Arformoterol. When Arformoterol is used, however, the maximum amount of SABA inhalation solutions that will be covered is an average of one dose per day (31 doses per month).

While it is always positive to have a mechanism for coverage for these therapies, CMS has again created a documentation hurdle for both the HME/pharmacy provider and the physician. When CMS was approached with a proposal to allow a patient to choose LABA or SABA, the idea was poorly received. For now, there is a mechanism to provide some of the needed aerosolized medications for patients, but to do so, you better get your jumping shoes on!

This article originally appeared in the Respiratory Management Jan/Feb 2008 issue of HME Business.