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New York Health Department Issues Rules for Dialysis Services Provided in Nursing Homes

The federal Centers for Medicare and Medicaid Services (CMS) has been pressing for more widespread use of home dialysis, and in August 2018 issued guidance to allow dialysis to be provided in nursing homes by an outside licensed dialysis provider.

The New York State Department of Health (DOH), in a Sept. 25, 2019, “Dear Administrator” letter, set forth its proposed new licensing model to allow dialysis to take place in more nursing homes. The proposed model would allow nursing homes seeking to offer dialysis on-site to submit a Limited Review Application (LRA) to the DOH. The DOH is establishing two new licensure categories that can be added to a nursing home’s operating certificate:

  • Hemodialysis at the patient’s bedside only; and
  • Hemodialysis performed in a dedicated treatment room or “den” at the home.

Homes seeking licensure in the second category will also be authorized to perform bedside dialysis.

Diagnostic and Treatment Centers (DTC) that provide renal dialysis services will have the ability to service patients in nursing homes and will be eligible to add a new category of licensure to their operating certificates: Nursing Home Hemodialysis. Such DTCs will have to already be state-licensed and federally certified to provide Home Hemodialysis Training and Support.

Process

Each nursing home wishing to provide dialysis services must submit an LRA to DOH to add the appropriate services to its operating certificate. If the LRA only involves bedside dialysis, an initial survey prior to commencing dialysis services will be at the DOH’s discretion. If the nursing home wishes to obtain approval for the construction of a treatment room or den, then an LRA or possibly a certificate-of-need application may be required for construction and/or reconfiguration that impacts resident space or the nursing home residents. The DOH will require a pre-opening survey for services provided in a treatment room or den. A separate LRA must be submitted for any subsequent treatment rooms or dens in the same facility.

Dialysis providers wishing to provide dialysis services in nursing homes must already be licensed by the DOH as a DTC and federally certified to perform Home Hemodialysis and Training and Support before submitting an LRA to DOH for licensure for nursing home hemodialysis. When submitting the LRA, the dialysis provider must include a dialysis contract with a nursing home, and the LRA must be linked to the nursing home’s LRA.

Limitations

Dialysis services provided on-site at nursing homes may only be provided to nursing home residents. Dialysis can only be performed on residents using machines approved for individual use.

Except for residents who have been trained and are able to self-perform dialysis, only registered nurses (RN) who are employees of the contracted dialysis DTC and meet the requirements of 10 NYCRR §757.2(a)(4) may perform dialysis on residents. These RNs are limited to providing treatment to no more than two residents at a time at the bedside, and four residents at one time in the treatment room. Nursing home RNs may only assist with peritoneal dialysis treatments, must have completed a training program, and can provide assistance under the supervision and direction of the contracted dialysis DTC.

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About this Author

Francis Serbaroli, Greenberg Traurig Law Firm, New York, Healthcare and Litigation Attorney
Shareholder

Francis J. Serbaroli is a shareholder in the Health Care & FDA Practice of Greenberg Traurig's New York office. Frank has three decades of experience in the health care industry. His clients include health insurers and managed care plans; hospitals, nursing homes, clinics, ambulatory surgery centers and home health agencies, clinical laboratories, renal dialysis providers, faculty practice plans, pharmaceutical companies, and medical device and equipment manufacturers. He handles a wide range of corporate, regulatory, compliance, reimbursement, corporate governance,...

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