Effective as of September 16, 2018, the Centers for Medicare and Medicaid Services (“CMS”) implemented a survey process for the provision of home dialysis services in long-term-care facilities (“LTC Facilities” or “Nursing Homes”). These new survey guidelines (“Additional Survey Activities”) stem from a recent memorandum that CMS issued to State Survey Agency Directors , which sets forth and outlines Additional Survey Activities that supplement the end-stage renal disease (“ESRD”) Core Survey requirements (the “Memorandum”).

To help ESRD providers and LTC Facilities navigate the Additional Survey Activities recently implemented by CMS, this Alert details the various survey phases and key takeaways from the Memorandum that providers should be aware of moving forward.

  1. Background

As CMS explains in its Memorandum, chronic dialysis patients who receive dialysis services must be under the care of a Medicare-certified ESRD facility in order for those services and treatments to be reimbursed by Medicare. Certified ESRD facilities must comply with the Conditions for Coverage (“CFCs”), which permit ESRD providers to provide dialysis services to LTC Facility residents one of two ways: (i) through in-center dialysis, which involves transporting the LTC Facility resident to and from a separately certified ESRD facility, which may be off-site or adjacent to the premises of the Nursing Home; or (ii) on the premises of the Nursing Home as home dialysis. In the second case, dialysis treatments are administered and supervised by personnel who meet CMS’ criteria for qualifications, training, and competency verification and are provided through a written agreement between the ESRD facility and the LTC Facility.

Certified ESRD facilities undergo CMS’ Core Survey process, which is designed to assess if the individual ESRD facility and on-site staff who deliver care are sufficiently qualified, knowledgeable, and equipped to provide safe and effective patient care. CMS implemented the ESRD Core Survey process to “efficiently utilize survey resources to identify deficient facility practices which most impact patient safety and clinical outcomes.” The ESRD Core Survey focuses on specific clinical areas in which performance improvement is needed based on facility-specific data and information.

CMS, through issuance of the Memorandum, updated the ESRD Core Survey process by implementing the Additional Survey Activities that address the provision of dialysis services by an ESRD facility to LTC Facility residents. CMS cautions that these Additional Survey Activities should be considered an extension of, and read in conjunction with, the ESRD Core Survey—they are not a replacement. Accordingly, CMS further cautions that providers should plan for additional survey time. Additionally, if ESRD facility surveyors identify possible concerns about the non-dialysis care provided to a Nursing Home resident, CMS directs the surveyors to communicate such concerns to the applicable state agency for a possible complaint investigation.

  1. Phases of the Additional Survey Requirements

CMS categorizes the Additional Survey Activities set forth in the Memorandum based on three (3) phases: (i) survey tasks conducted at the ESRD facility prior to the on-site visit at the LTC Facility; (ii) survey tasks conducted at the Nursing Home; and (iii) survey tasks conducted at the ESRD facility after the on-site visit at the LTC Facility. This Section provides an overview of each phase and its key tasks, which ESRD providers and nursing homes should be aware of as they prepare for their survey.

  1. Survey Tasks at the ESRD Facility Prior to the On-Site Visit at the LTC Facility. The first Additional Survey Activity phase includes those tasks that are conducted at the ESRD facility prior to the site visit by the surveyors at the LTC Facility. CMS has set forth a fulsome list of activities in its Memorandum, but the key tasks include:

i. Entrance Conference. To facilitate planning for on-site visits at the Nursing Home, surveyors will ask the ESRD facility for certain information at the time of the ESRD survey entrance conference, including but not limited to a list of all nursing homes with which the ESRD facility has a current written agreement to provide dialysis services, the names of all patients currently receiving dialysis services from the ESRD facility at each nursing home, and the names and credentials of any nursing home personnel who deliver dialysis treatments to residents.

ii. ESRD Personnel Interviews. Surveyors will interview members of the ESRD facility’s interdisciplinary team to gather information regarding the services to be provided to LTC Facility residents.

iii. Review of Written Coordination Agreement. The surveyors will review each written agreement in place between the ESRD facility and the nursing home(s) at which the ESRD facility provides home dialysis services in order to ensure that each agreement contains a clear delineation of responsibilities. The coordination agreement should differentiate between the tasks for which the ESRD facility is responsible, such as testing and monitoring the water and dialysate quality for hemodialysis equipment, and those for which the nursing home is responsible, such as protecting the dialysis equipment and supplies from unauthorized access. The coordination agreement should also identify those activities that are shared responsibilities of both the ESRD facility and the Nursing Home, such as complete, timely, and accurate documentation of all assessments. ESRD providers and Nursing Homes who have previously entered into a coordination agreement should review the terms of such agreement to ensure that it complies with the specific delineations set forth in the Memorandum.

  1. Survey Tasks Conducted at the Nursing Home. The second phase of the Additional Survey Activities includes those tasks that are conducted at the Nursing Home. Such activities include but are not limited to the following:

i. Review of the Nursing Home Dialysis Environment. Surveyors will observe the location(s) where residents receive dialysis treatments as well as the locations in which the dialysis equipment and supplies are stored. Among other things, surveyors will look for and note unsanitary conditions, dialysis equipment in poor repair, and whether equipment is protected from unauthorized access.

ii. Observations of Nursing Home Dialysis Care. CMS directs surveyors to observe the direct dialysis care of sampled residents, including but not limited to the set-up, initiation of treatment, vascular access check, and discontinuation of treatment. CMS expressly states that, given the length of time each treatment may require, all required observations need not be conducted on the same resident.

iii. Interviews with Nursing Home Personnel and LTC Facility Residents Receiving Dialysis Services. Surveyors will interview both Nursing Home personnel who administer and supervise the dialysis treatments as well as those LTC Facility residents who receive such treatments. The Memorandum provides samples of interview questions, such as “How did you decide to get your dialysis treatments here in the nursing home?” for a resident undergoing treatment, and, for Nursing Home personnel “what training did you receive to enable you to administer dialysis treatments?”

  1. Survey Tasks Conducted at the ESRD Facility After the On-Site Visit. The last phase of CMS’ Additional Survey Activities specific to the provision of home dialysis in a Nursing Home include those tasks that are conducted by the surveyors at the ESRD facility after they have visited the Nursing Home at which the dialysis services are provided. Examples of tasks include but are not limited to the following:

i. Water Treatment and Dialysate Review. The ESRD facility is responsible for assuring that the water and dialysate for Nursing Home hemodialysis equipment meets the CFCs quality standards. In evaluating that question, surveyors will review the facility’s documentation, dialysate records, and quality results.

ii. Medical Records Review. Surveyors will review information set forth in the ESRD facility medical records to ensure that they contain specific information set forth in the Memorandum.

iii. Training and Competency Review. Surveyors will review and analyze the training and competency records of the personnel in the Nursing Home who administer the dialysis treatments, ensuring that such personnel have successfully completed a qualified training program and have undergone initial (as well as ongoing) competency testing.

  1. Key Takeaways

CMS has added a number of Additional Survey Activities applicable to ESRD providers who will render dialysis services to LTC Facility residents. Accordingly, such providers and Nursing Homes should read and review the Memorandum to ensure that they understand the additional requirements. Providers should also be prepared for the multiple-phased survey process, which will take significant time and consist of in-depth document review. Lastly, ESRD providers and Nursing Homes should review their current coordination agreements to ensure that they meet the requirements set forth in CMS’s Memorandum.