Neb-med proposal: AAH has sharp words for CMS

Sunday, May 7, 2006

WASHINGTON - AAHomecare last week criticized CMS's proposal to reimburse brand-name respiratory medications at cheaper generic rates, claiming it could force doctors to prescribe drugs based on their cost, not their clinical effectiveness.

With respiratory medication providers unwilling to take a loss on the drugs, many in the HME industry believe the proposal would sharply curtail access to brand drugs Xopenex and DuoNeb.

AAHomecare planned to submit comments on the LCD by the May 8 deadline.

The association's concerns also include:

- The proposal would eliminate the physician's ability to effectively prescribe medically necessary drugs in the best interest of the patient's health.

- The Program Safeguard Contractors (PSCs) have not established that there is no therapeutic difference between levalbuterol and albuterol or no benefit to non-compounded combined albuterol and ipratropium bromide. The PSCs provided data from 22 literature references when several hundred exist, many of which do provide evidence of therapeutic differences between the branded and generic drugs. Such a selected literature search provides a slanted view of two of the primary drugs used for several years to treat the fourth-leading cause of death, chronic obstructive pulmonary disease (COPD).

- Medical practice and standards of care are typically based on the best available evidence, clinical standards of practice, and individual physician assessment and judgment. Because many of these applications and dosing regimens are patient-specific, there are often little if any published data to support a particular application with a particular patient. However, the absence of published science with regard to the targeted drugs does not equate to an absence of medical necessity on the patient's part.

Based on Medicare expenditures from 2003 and 2004, an estimated 1 million beneficiaries require home inhalation therapy. Further, about 500,000 beneficiaries currently require either DuoNeb or Xopenex.