Sepracor Issues Statement Regarding CMS Medicare Part B Reimbursement Change for XOPENEX(R) Inhalation Solution
Sepracor Inc. (Nasdaq: SEPR) today announced that the Centers for Medicare and Medicaid Services (CMS) has issued its proposed new, bundled, third quarter 2007 payment amount for XOPENEXÃ‚® (levalbuterol HCl) Inhalation Solution and generic albuterol inhalation solution products. The new Medicare Part B reimbursement rate announced by CMS is $0.525 per 0.5 mg of levalbuterol and $0.525 per 1 mg of generic albuterol. This translates into $1.31 per unit dose for the 1.25 mg dose of XOPENEX Inhalation Solution, which is the dose of XOPENEX Inhalation Solution most commonly used by Medicare Part B beneficiaries. This reimbursement rate is expected to go into effect on July 1, 2007.
This new reimbursement price results from an action by the CMS to discontinue the unique Medicare Part B billing and payment code for XOPENEX Inhalation Solution and bundle this single-source, branded drug with many generic albuterol inhalation solution drugs. Because of the bundling of the two medications, this new, blended reimbursement rate significantly lowers the current reimbursement rate for XOPENEX Inhalation Solution and significantly raises the current reimbursement rate for generic albuterol. Sepracor believes that tens of thousands of physicians have prescribed XOPENEX Inhalation Solution for many thousands of Medicare Part B beneficiaries with respiratory disease because they believed, in their clinical judgment, that XOPENEX Inhalation Solution was the most appropriate choice. Sepracor further believes that this action by CMS marks the first time a single-source, innovative product has been bundled with generic, multi-source drugs that are not therapeutic equivalents for Medicare Part B reimbursement purposes. Sepracor hopes to work with government officials to pursue better alternatives to the proposed bundling of XOPENEX Inhalation Solution and generic albuterol inhalation solution drugs.
Sepracor cannot currently reasonably estimate the potential impact of this change in the Medicare Part B reimbursement rate on XOPENEX Inhalation Solution utilization or to XOPENEX Inhalation Solution revenues from the Medicare Part B market.
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor’s drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Sepracor’s corporate headquarters are located in Marlborough, Massachusetts.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the impact of the new, bundled, reimbursement rate for XOPENEX Inhalation Solution; Sepracor’s belief that tens of thousands of physicians have prescribed XOPENEX Inhalation Solution for many thousands of Medicare Part B beneficiaries with respiratory disease because they believed, in their clinical judgment, that XOPENEX Inhalation Solution was the most appropriate choice; and Sepracor’s ability to work with government officials to try to pursue better alternatives to the proposed bundling of XOPENEX Inhalation Solution and generic albuterol inhalation solution drugs. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: Sepracor’s ability to maintain coverage of its products by government agencies and the effects of the potential loss or decrease of such coverage with such agencies, such as CMS; the regulatory environment surrounding branded and generic prescription drugs; changes in the business and regulation of health care reimbursement and the medical community’s response to such changes; private insurers, such as managed care organizations, adopting their own coverage restrictions or demanding price concessions in response to state, Federal or administrative action, such as CMS’s proposed bundling action; and certain other factors that may affect future operating results and are detailed in the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2007 filed with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor’s expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor’s expectations or beliefs as of any date subsequent to the date of this press release.
Xopenex is a registered trademark of Sepracor Inc.
For a copy of this release or any recent release, visit Sepracor’s web site at www.sepracor.com.