Department of Health and Human Services

1 VerDate Aug<31>2005 17:35 Apr 14, 2008 Jkt 214001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\ 15 APR2 PWALKER on PROD1PC71 with RULES2 Tuesday, April 15, 2008 Part II Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, 413 et al. Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule VerDate Aug<31>2005 17:35 Apr 14, 2008 Jkt 214001PO 00000 Frm 00002 Fmt 4701 Sfmt 4700E:\FR\FM\ on PROD1PC71 with RULES220370 federal Register / Vol. 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations Department OF Health AND Human Services Centers for Medicare & Medicaid Services 42 CFR Parts 405, 410, 413, 414, 488, and 494 [CMS 3818 F] RIN 0938 AG82 Medicare and Medicaid Programs; Conditions for Coverage for End-Stage Renal Disease Facilities AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

2 ACTION: Final rule. SUMMARY: This rule finalizes the February 4, 2005 proposed rule entitled Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities. It establishes new conditions for coverage that dialysis facilities must meet to be certified under the Medicare program. This final rule focuses on the patient and the results of care provided to the patient, establishes performance expectations for facilities, encourages patients to participate in their plan of care and treatment, eliminates many procedural requirements from the previous conditions for coverage, preserves strong process measures when necessary to promote meaningful patient safety, well-being, and continuous quality improvement.

3 This final rule reflects the advances in dialysis technology and standard care practices since the requirements were last revised in their entirety in 1976. DATES: The provisions of this final rule are effective October 14, 2008. Compliance with (a)(1)(i) and (e)(1) is not required until February 9, 2009. In addition, the compliance with (h) is effective on February 1, 2009. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the federal Register as of October 14, 2008. FOR FURTHER INFORMATION CONTACT: Lynn Riley, (410) 786 1286, Stefan Miller, (410) 786 6656, Lauren Oviatt, (410) 786 4683, Judith Kari, (410) 786 6829, (Survey and Certification), Teresa Casey, (410) 786 7215, (Issues related to Quality Assessment Performance Improvement).

4 SUPPLEMENTARY INFORMATION: Table of Contents I. Background A. Introduction B. Legislative History C. Existing ESRD Regulations D. The Establishment of Central Requirements II. Summary of the Proposed Provisions and Response to Comments on the February 4, 2005 Proposed Rule A. Part 414 Payment for Part B Medical and Other Health Services ; Payment for Home Dialysis Equipment, Supplies, and Support Services (Proposed ) B. Part 488 Survey, Certification, and Enforcement Procedures; Special Procedures for Approving End-Stage Renal Disease Facilities (Proposed ) C. Part 494 Conditions for Coverage for End-Stage Renal Disease Facilities 1. Subpart A General Provisions a.

5 Basis and Scope (Proposed ) b. Definitions (Proposed ) c. Compliance With federal , State, and Local Laws and Regulations (Proposed ) 2. Subpart B Patient Safety a. Infection Control (Proposed ) b. Water and Dialysate Quality (Proposed ) c. Reuse of Hemodialyzers and Bloodlines (Proposed ) d. Physical Environment (Proposed ) 3. Subpart C Patient Care a. Patients Rights (Proposed ) b. Patient Assessment (Proposed ) c. Patient Plan of Care (Proposed ) d. Care at Home (Proposed ) e. Quality Assessment and Performance Improvement (Proposed ) f. Special Purpose Renal Dialysis Facilities (Proposed ) g. Laboratory Services (Proposed ) 4.

6 Subpart D Administration a. Personnel Qualifications (Proposed ) b. Responsibilities of the Medical Director (Proposed ) c. Relationship With the ESRD Network (Proposed ) d. Medical Records (Proposed ) e. Governance (Proposed ) D. Other Proposed Changes and Issues 1. Proposed Cross-Reference Changes 2. Proposed Additions to Part 488 E. Survey & Certification Comments F. Impact Analysis Comments III. Provisions of the Final Rule IV. Effective Dates for the Final Rule V. Reference Materials A. Provisions of Part 494 B. ESRD Crosswalk VI. Collection of Information Requirement VII. Regulatory Impact Analysis Regulations Text Acronym List AAMI Association for the Advancement of Medical Instrumentation ACLS Advanced Cardiac Life Support ADA American Dietetic Association AED Automated external defibrillator AIA American Institute of Architects AHA American Heart Association ALT Alanine Aminotransferase APA Administrative Procedures Act ANSI American National Standards Institute BMI Body mass index BONENT Board of Nephrology Nursing Examiners Nursing and Technology BSW Bachelor s degree social worker CADE Commission on Accreditation for Dietetics Education CAHPS Consumer Assessment of Health Plans Survey CCHT Certified Clinical Hemodialysis

7 Technician CDC Centers for Disease Control and Prevention CEO Chief executive officer CLIA Clinical Laboratory Improvement Amendments CMS Centers for Medicare and Medicaid Services CNSW Council of Nephrology Social Workers CPG Clinical practice guidelines CPM Clinical performance measures CRAFT CROWN Responsiveness and Feedback Tree CROWNWeb Consolidated Renal Operations in a Web-enabled Network DFC Dialysis Facility Compare DHHS Department of Health and Human Services DOPPS Dialysis Outcomes and Practice Patterns Study DOQI Disease Outcomes Quality Initiative DTR Dietetic Technician, Registered EDI Electronic Data Interchange EMS Emergency medical system ESRD End-Stage renal disease FDA Food and Drug Administration HBsAg Hepatitis B surface antigen HIPAA Health Insurance Portability and Accountability Act 1996 HBV Hepatitis B virus HCV Hepatitis C virus HICPAC Healthcare Infection Control Practices Advisory Committee HMO Health Maintenance Organization ICC International Code Council ICH In-center hemodialysis IOM Institute of Medicine KCP Kidney Care Partners KDOQI Kidney Disease Outcomes Quality Initiative K/DOQI Kidney Disease Outcomes Quality Initiative LAL Amoebocyte lysate LDO Large dialysis organization LPN Licensed practical nurse LVN

8 Licensed vocational nurse LSC Life Safety Code MedPAC Medicare Payment Advisory Commission MNT Medical nutrition therapy MPD Mission and Priority Document MSW Master s degree social worker NCD National Coverage Determination NF Nursing Facility NKF National Kidney Foundation NKF KDOQI National Kidney Foundation s Kidney Disease Outcomes Quality Initiative NNCC Nephrology Nursing Certification Commission NNCO National Nephrology Certification Organization NQF National Quality Forum NTTAA National Technology Transfer and Advancement Act of 1995 OIG Office of the Inspector General PA Physician assistant VerDate Aug<31>2005 17:35 Apr 14, 2008 Jkt 214001PO 00000 Frm 00003 Fmt 4701 Sfmt 4700E:\FR\FM\ on PROD1PC71 with RULES2 federal Register / Vol.

9 73, No. 73 / Tuesday, April 15, 2008 / Rules and Regulations 20371 PCT Patient care technician QAPI Quality assessment and performance improvement QIS Quality Infrastructure Report RD Registered dietitian RN Registered nurse REMIS Renal Management Information System RO Reverse osmosis RPA Renal Physicians Association SGA Subjective global assessment SHEA Society for Healthcare Epidemiology of America SNF Skilled nursing facility SOW Scope of work STIC Safe and Timely Immunization Coalition TEP Technical Expert Panel VISION Vital Information System to Improve Outcomes in Nephrology I. Background A. Introduction End-Stage Renal Disease (ESRD) is a kidney impairment that is irreversible and permanent and requires either a regular course of dialysis or kidney transplantation to maintain life.

10 Dialysis is the process of cleaning the blood and removing excess fluid artificially with special equipment when the kidneys have failed. Our existing ESRD Services conditions for coverage were originally adopted in 1976 (41 FR 22502). In our existing requirements for dialysis facilities at 42 CFR part 405, subpart U, we emphasize the policies and procedures that must be in place to support good patient care, and we focus on a facility s capacity to furnish quality care. To determine if a facility meets ESRD conditions for coverage, the State survey agency performs an on-site survey of the facility. If a survey indicates that a facility is in compliance with the conditions, and all other federal requirements are met, we then certify the facility as qualifying for Medicare payment.