In February 2018, Congress passed a law allowing deemed status for ESRD facilities, which had been specifically prohibited by the 1972 law that provided Medicare coverage for ESRD. The 2018 law allowed accreditation organizations to apply to the Centers for Medicare and Medicaid Services (CMS) for deemed status. The following is an interview with Glenda Payne, an owner of National Dialysis Accreditation Commission (NDAC), the first accreditation organization to earn deemed status from CMS for survey of ESRD facilities.
Kidney News (KN): What is the difference between accreditation and certification?
Glenda Payne (GP): Accreditation is awarded to a facility that meets the standards of the accrediting organization (AO). CMS awards certification based on the successful completion of an initial survey by either a state agency, or by an AO with deemed status. Certification by CMS is required to receive payment for care of Medicare beneficiaries.
KN What is “deemed status?”
GP Deemed status means that an AO’s standards and survey process have been reviewed by CMS and found to be equivalent to the CMS regulations and survey process for a specific provider type.
KN What does it mean if a dialysis facility is accredited with deemed status?
GP It means that the dialysis facility has successfully completed a survey by an AO with deemed status, that CMS will certify (and pay) the facility for care of Medicare beneficiaries, and that the facility is largely exempt from oversight by the state agency.
KN Are AOs with deemed status contractors for CMS?
GP No. AOs are independent organizations with no direct ties to a government entity. They apply to CMS for deemed status and must report survey information to CMS, but are not a part of a government agency.
KN In the 27 states that require ESRD facilities to be licensed, are AOs allowed to do the state licensing surveys?
GP This varies by state. Most states retain the right to conduct the initial licensing survey, but an AO can do the initial survey for Medicare certification by deemed status after the facility completes licensing requirements and begins to provide service. Several states are open to collaborative agreements with AOs to allow the AO to do subsequent licensing surveys.
KN What are the differences between an AO survey and a state survey?
GP The AO survey process must be equivalent to the CMS survey process. In our case, the NDAC survey process is based on the CMS Core Survey process and uses tools that are very similar to those the state surveyor uses. Another difference with NDAC is that all surveyors have dialysis expertise and there is a centralized review of the findings of every survey.
KN What is the cost of an AO survey?
GP An AO sets the cost of the survey, and the various AOs entering this market may charge different rates. The cost of a basic survey by NDAC covers a three-day survey by an experienced dialysis nurse, a full written report within 10 working days, and upon receipt of an acceptable plan for any cited deficient practices, accreditation with deemed status for three years.
KN Will an AO do complaint investigations?
GP Yes, an AO is expected to be able to investigate all complaints received. Accredited facilities are expected to post a notice with contact information for the AO. If the state agency or CMS receives a complaint with allegations that pose a serious risk to patient health and safety, the state will be authorized to conduct the investigation. Less serious complaints received by the state or CMS are to be referred to the AO.
KN Will an AO be able to do surveys to add services or stations, for example to add home dialysis services?
GP Yes, AOs can do expansion surveys, including surveys to add home dialysis services. This survey would include accreditation of the in-center services if those were not already accredited.
KN Can an AO limit its service area to particular states?
GP No. CMS requires all AOs to provide service to all US states and territories.
KN How long is the accreditation “good?”
GP CMS limits the accreditation period to 3 years. Each accredited facility will need to be resurveyed within 36 months to maintain accreditation with deemed status.
KN How will CMS oversee AOs with deemed status for ESRD?
GP There is a rigorous approval process that is repeated every 4 to 6 years. This includes review of the AO Standards and policies and procedures, surveys completed, qualifications and training of staff, and observation of an actual survey. In addition, CMS reviews the findings and the accepted plan of correction for each initial survey including the first accreditation survey of existing facilities. AOs are required to submit data every month to include surveys completed the last month, the outcomes of those surveys, and the schedule of surveys for the following month. Finally, CMS conducts validation surveys to ensure the AO is continuing to use a survey process that is equivalent to the CMS process.
KN Why would a dialysis facility choose accreditation over remaining under state oversight?
GP Our clients have given us several reasons:
• Consistency. Having experienced dialysis nurses conduct the survey and review of the findings centrally means there is assurance that all surveyors follow the AO Standards as written and that there is more likelihood of the “same survey” being done each time, eliminating the survey variance from surveyor to surveyor or from state to state.
• Predictability. Knowing that the surveys will be done within 36 months helps to maintain “survey readiness” at all times.
• Clinical rigor. Having experienced dialysis nurses who know the Standards and apply them fairly in every survey increases the likelihood that serious issues will be identified so that steps can be taken to improve safety and reduce risks of poor patient outcomes.
• Timeliness. While the same law that allowed deemed status also mandates CMS conduct initial surveys of dialysis facilities within 90 days of readiness, shaving just weeks off of that timeline can significantly reduce start-up costs. Since there is no mandate for CMS timeliness in adding services or stations, using an AO for these survey needs can speed up that approval by months.
Note: The Accreditation Commission for Health Care was approved for deemed status in April 2019.