The long-awaited final rule replacing the “Conditions for Coverage” (the “Conditions”) for End-Stage Renal Disease (“ESRD”) facilities to participate in Medicare was released by the Centers for Medicare and Medicaid (“CMS”) on April 3, 2008. The final rule marks the first revision to the Conditions since they were originally enacted in 1976, dramatically altering the requirements from a process-oriented to a patient-centered, outcome-oriented approach. The final rule will become effective once it is published in the Federal Register, which we anticipate should occur in the coming week.
The following responds to some of the key questions, which the new Conditions raise for ESRD suppliers:
Who will the new Conditions impact?
Changes to the Conditions will impact all existing ESRD facilities certified to provide dialysis services under Medicare and any new ESRD facilities seeking certification. However, the new Conditions are likely to have a greater impact on independently-owned facilities not associated with a major dialysis chain since, according to CMS, those facilities are less likely to have adopted Life and Safety Code recommendations and other national standards incorporated by reference into the new Conditions. CMS reports that approximately one-third of existing Medicare-certified ESRD facilities fall into this category.[1]
The final Conditions have a significant impact on certain personnel qualifications, which may open doors for some, close doors for others and cause a number to seek certification in order to maintain their positions.
- Medical Directors: Medical directors formerly could be either board eligible or board certified in internal medicine or pediatrics.[2] Board eligibility is no longer sufficient under the new Conditions. All physicians are now required to be board certified in internal medicine or pediatrics in order to serve as a medical director of a Medicare-certified ESRD facility. Existing medical directors will have 180 days in order to become board certified. The new rule does not provide for grandfathering of existing medical directors, but does permit the Secretary of the Department of Health and Human Services to approve a physician that does not meet such requirements to serve as a medical director in the absence of a qualified physician. Under the new Conditions, medical directors are accountable to governing body of the facility for the quality of medical care provided to patients.
- Patient Care Technicians: Under the proposed rule, patient care technicians would have been required to spend three months under the direct supervision of a licensed registered nurse (“RN”). The final Conditions decline to adopt that requirement, and instead require that all patient care technicians obtain certification under a state or national commercially available certification program within 18 months of being hired, or if already employed, then within 18 months of publication of the final rule.
- Licensed Registered Nurses: ESRD facilities were formerly required to have a licensed physician, licensed practical nurse or RN onsite at all times patients were dialyzed. The new Conditions eliminate the option to rely exclusively on LPN supervision and specify that a RN must be present at times patients are dialyzed.
- Medical Record Practitioner: Under the former Conditions, a medical record practitioner had to complete a particular course of study. The new Conditions eliminate the position and requirements for a medical record supervisor in its entirety.
- Chief Executive Officer: Under the former Conditions, CEOs were required to meet one of three alternative criteria. The new Conditions eliminate any specific qualification requirements that facility CEOs must meet, which should allow facilities greater flexibility in hiring.
How much time do ESRD facilities have in order to comply?
Once the final rule is published in the Federal Register (which CMS reported was to occur on April 4, 2008, but has not yet taken place), ESRD facilities will have 180 days to comply with the new Conditions, with the following exceptions:
- ESRD facilities will be given an additional four months (300 days total from the date of publication) in order to comply with:
- Isolation room requirements for HBV-infected patients in order to allow for project development, construction approvals, architectural design, contractor bids and obtaining building permits.
- Applicable provisions of the 2000 Edition of the Life Safety Code of the National Fire Protection Association (“LSC”) in order to accomplish necessary changes in building structure.
- The provision pertaining to furnishing data and information in electronic format to CMS, including cost reports, ESRD administrative forms, patient survival information and existing and future clinical performance measures will not take effect until February 1, 2009 in order for facilities to develop programs or obtain software to meet electronic requirements.
What are some of the increased burdens ESRD facilities will face under the new Conditions?
In addition to those personnel burdens described above for medical directors and patient care technicians, ESRD facilities may face the need for construction, changes in policies and procedures, personnel training and equipment requirements.
- Construction: Existing facilities may be forced to commence construction in order to create separate demarcated areas for HBV-infected patients, and install systems in order to meet LSC requirements, such as fire department alarm connections. Facilities may seek and be granted a reprieve from such construction requirements if they can demonstrate that the health and safety of patients and staff would not be adversely affected. CMS has the ability to waive specific provisions of the LSC, which if rigidly applied would result in unreasonable hardship for the facility. Further, facilities may apply for an isolation room waiver when a sufficient number of isolation rooms exist locally for HBV-infected patients.
- Policies and Procedures: Emergencies: Plans must be developed to obtain emergency medical system assistance and annually review emergency and disaster plans. Specific materials will need to be provided to patients in cases of emergencies as well. Patient Care: The final Conditions modify a variety of care, counseling and assessments the interdisciplinary team is responsible for conducting, including: monthly measurement of a patient’s albumin level and body weight, necessary care for management of mineral metabolism to prevent or treat renal bone disease, evaluation of whether patient is potential candidate for arteriovenous fistula placement, training of patients in infection prevention and personal care, home dialysis and self-care, and benefits and risks of various vascular access types. The Conditions also mandate patient privacy when being examined, reasonable accommodations for discomfort from temperature in facility, and that patients be within physical view of staff at all times during hemodialysis. Patient Rights: Facilities must also develop and prominently display written patients’ rights policies containing information regarding advance directives, how to contact entities in regard to complaints and dialysis modalities not offered by the facility, including scheduling options for working patients. Facilities are also required to implement an in-house grievance procedure.
- Emergencies: Plans must be developed to obtain emergency medical system assistance and annually review emergency and disaster plans. Specific materials will need to be provided to patients in cases of emergencies as well.
- Patient Care: The final Conditions modify a variety of care, counseling and assessments the interdisciplinary team is responsible for conducting, including: monthly measurement of a patient’s albumin level and body weight, necessary care for management of mineral metabolism to prevent or treat renal bone disease, evaluation of whether patient is potential candidate for arteriovenous fistula placement, training of patients in infection prevention and personal care, home dialysis and self-care, and benefits and risks of various vascular access types. The Conditions also mandate patient privacy when being examined, reasonable accommodations for discomfort from temperature in facility, and that patients be within physical view of staff at all times during hemodialysis.
- Patient Rights: Facilities must also develop and prominently display written patients’ rights policies containing information regarding advance directives, how to contact entities in regard to complaints and dialysis modalities not offered by the facility, including scheduling options for working patients. Facilities are also required to implement an in-house grievance procedure.
- Personnel Training: Facility patient care staff must maintain current CPR certification, and water system technicians and patient care technicians must attend required training programs.
- Equipment: The following emergency equipment must be immediately available in facility: oxygen, airways, suction, and a defibrillator or automated external defibrillator.
Will any burdens be alleviated by the new Conditions?
The final Conditions provide greater flexibility in the maintenance of medical records, eliminate the requirement for translators, remove the requirement for a separate long-term care program, reduce the frequency of formal care planning after initial 6 months of dialysis, and no longer require CEOs to be involved in the annual review for emergency preparedness. Moreover, in light of the increased scrutiny that the Office of Inspector General of the Department of Health and Human Services (“OIG”) is placing on quality of care in investigating health care fraud, the new Conditions should serve as important benchmarks for ESRD facilities to implement quality of care initiatives.
NOTES:
1. Those facilities that have already incorporated some of the following standard policies and procedures will have a head start on complying with the final CFC requirements: (i) AAMI “Dialysate for hemodialysis” water purity guidelines; (ii) AAMI guidelines for the “Reuse of hemodialyzers”; (iii) procedures for monthly review of patient’s dialysis prescription; (iv) transplantation referral tracking; (v) quality assessment and performance improvement program; and (vi) guidelines for the Prevention of Intravascular Catheter-Related Infections pertaining to placement of intravascular catheters and Central Venous Catheters.
2. 42 CFR 2102(e).