2014

NxStage Submits Formal Comments to CMS to Improve Patient Access to Life-changing More Frequent Home Hemodialysis Therapy Company calls for CMS to fix reimbursement for home hemodialysis training to provide Medicare patients greater access to more frequent home hemodialysis therapy proven to improve patient survival rates and quality of life

LAWRENCE, Mass., Sept. 6, 2012 /PRNewswire/ -- NxStage® Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced that it submitted public comments to the Centers for Medicare and Medicaid Services (CMS) regarding its Proposed Rule for the Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System for 2013. NxStage's comments call for CMS to correct the current insufficient and inequitable payments for home hemodialysis (HHD) training—making this life-changing modality more accessible to Medicare patients suffering from ESRD.

(Logo: http://photos.prnewswire.com/prnh/20110503/MM94799LOGO )

The Company calls for these changes based upon:

  • Recognition by experts of the limitations of conventional modalities in addressing specific health conditions;
  • Clinical data supporting superior patient outcomes with more frequent HHD vs. conventional dialysis;
  • Multiple third-party surveys showing that nephrologists and other healthcare professionals would choose HHD most often for themselves if faced with ESRD; and
  • A Congressional mandate for CMS to develop policy that encourages more patients to be treated in the home setting.

"The current Medicare payment system doesn't provide adequate reimbursement for patients to be trained on HHD and represents an unintended injustice to those patients who wish to perform HHD," said Joe Turk, President, North America, NxStage Medical, Inc. "The status quo is inconsistent with the Congressional mandate to bring patients home and is a huge factor in Medicare ESRD patients' limited access to more frequent HHD. This issue can and should be addressed to allow patients better access to this life-changing therapy, that so often leads to longer, healthier lives for patients who require dialysis to live."

A copy of the Company's submission can be found at http://www.regulations.gov/#!documentDetail;D=CMS-2012-0080-0053.

About the NxStage System One

The NxStage System One is the first and only truly portable hemodialysis system cleared for home use by the U.S. Food & Drug Administration (FDA). Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy.   When combined with the NxStage Pureflow SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid on demand.  Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, at home or on vacation. http://www.nxstage.com/.

About NxStage Medical

NxStage Medical, Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative systems for the treatment of end-stage renal disease, or ESRD, and acute kidney failure. NxStage is leading the development of the home hemodialysis market in the US with the only portable hemodialysis machine, the System One, cleared for home use by the FDA. For more information on NxStage and its products, please visit the company's website at http://www.nxstage.com/.

Forward-Looking Statements

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words "anticipate," "believe," "expect," "estimate," "plan," and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those that are discussed in NxStage's filings with the Securities and Exchange Commission, including the Quarterly Report on Form 10-Q for the quarter ended June 30, 2012. NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:
Kristen K. Sheppard, Esq.
VP, Investor Relations
ksheppard@nxstage.com

SOURCE NxStage Medical, Inc.



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