CMS SOM App. H, Tag V771

§ 494.180(h) Standard: Furnishing data and information for ESRD program

administration. Effective February 1, 2009, the dialysis facility must furnish data and

information to CMS and at intervals as specified by the Secretary. This information is used

in a national ESRD information system and in compilations relevant to program

administration, including claims processing and reimbursement, quality improvement, and

performance assessment. The data and information must—

(1) Be submitted at the intervals specified by the Secretary;

(2) Be submitted electronically in the format specified by the Secretary;

(3) Include, but not be limited to—

(i) Cost reports;

(ii) ESRD administrative forms;

(iii) Patient survival information; and

(iv) Existing ESRD clinical performance measures, and any future clinical performance

standards developed in accordance with a voluntary consensus standards process identified

by the Secretary.

Interpretive Guidance § 494.180 (h)(1), (2), and (3)(i)-(iv):

Beginning February 1, 2009, all dialysis facilities must electronically submit data to allow

patient enrollment in and disenrollment from the ESRD benefit program, assessment of clinical

outcomes, and claims processing.

The facility must electronically submit the required information at the specified intervals, which

vary depending on the data element. Data required to be submitted electronically includes: cost

report data; administrative data (such as changes in key staff and changes in patient treatment

modality); forms such as the CMS-2728 (ESRD Medical Evidence Report Medicare Entitlement

and/o Patient Registration) and CMS-2746 (ESRD Death Notification); and, clinical

performance data on all patients regardless of payment source, at the frequency determined by

CMS. The clinical performance measures required for submission are determined by the

Secretary of HHS, and any changes to these measures will be developed through a standardized

process. Additional information on clinical performance measures for ESRD facilities can be

found here: ESRD Quality Incentive Program.