The Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have announced an array of guidance to combat the spread of COVID-19 and ease provider regulatory burden. In light of the unique challenges that COVID-19 presents for dialysis management, CMS and CDC have issued targeted guidance for dialysis facilities over the past several weeks. This article pulls together this recent targeted guidance for dialysis facilities by providing: (a) a summary of the CMS waivers issued to end-stage renal disease (ESRD) facilities and (b) a summary of key updates made to CDC and CMS recommendations regarding infection control for dialysis facilities treating patients with suspected or confirmed COVID-19.
CMS Guidance for Dialysis Facilities
A. Summary of Waivers and Flexibilities for Dialysis Facilities
On April 21, 2020, CMS released numerous blanket waivers to help health care providers contain the spread of COVID-19. These waivers, enumerated in COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, have a retroactive effective date of March 1, 2020, and will remain in effect through the end of the national emergency declaration. The April 21, 2020 CMS guidance on ESRD facilities supplements and amends CMS’ prior guidance from March 28, 2020, in which CMS provided certain flexibilities to ESRD facilities under the Medicare conditions of participation.
Under the updated guidance, CMS revised and clarified several of the ESRD-specific waivers included in its March 28, 2020 guidance on topics including training and audits, preventive maintenance, emergency preparedness, patient assessment, care planning, home visits, home dialysis machine designations, special purpose renal dialysis facilities designations, dialysis patient care technician certification, physician credentialing and payment and reimbursement. We have provided a summary of the cumulative guidance and waivers to ESRD facilities below.
- Training Program and Periodic Audits. CMS waived the requirement at 42 CFR § 494.40(a) related to the condition of Water & Dialysate Quality. Specifically, CMS waived on-time periodic audits for operators of the water/dialysate equipment to allow for flexibilities. The April 21, 2020 guidance clarified a typographical error on the citation from the March 28, 2020 guidance.
- Defer Equipment Maintenance and Fire Safety Inspections. CMS waived the requirement at 42 CFR § 494.60(b) for on-time preventive maintenance of dialysis machines and ancillary dialysis equipment, as well as the 42 CFR § 494.60(d) requirement for ESRD facilities to conduct on-time fire inspections.
- Emergency Preparedness. Due to the limited availability of CPR classes during the COVID-19 emergency, CMS waived the requirement found at 42 CFR § 494.62(d)(1)(iv) for the maintenance of CPR certification by patient care staff. The April 21, 2020 guidance clarified a typographical error on the citation from the March 28, 2020 guidance.
- Ability to Delay Some Patient Assessments. CMS waived the “on-time” requirements at 42 CFR §§ 494.80(b)(1)-(2) for the initial and follow-up comprehensive assessment of all admitted patients. Specifically, CMS waived the requirements that (i) an initial comprehensive assessment must be conducted within the later of 30 calendar days or 13 outpatient hemodialysis sessions, starting with the first outpatient dialysis session, and (ii) follow-up comprehensive reassessments within three months after completing the initial assessment. CMS emphasized that it is not waiving subsections (a) or (c) of 42 CFR § 494.80 regarding the criteria for the patient’s comprehensive assessment and the adequacy of the patient’s treatment prescription.
- Medicare Telehealth for ESRD. CMS waived certain requirements with respect to ESRD beneficiaries to facilitate telehealth. CMS waived the time requirement at 42 CFR § 494.90(b)(2) requiring dialysis facilities to implement an initial plan of care within the later of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session, and update the plan monthly or annually within 15 days of the completion of additional patient assessments. CMS also modified the requirement at 42 CFR § 494.90(b)(4) by waiving the monthly in-person visit requirement if the patient is considered stable and recommends that dialysis facilities utilize telehealth capabilities to ensure patient safety in the absence of such visits.
- Dialysis Home Visits to Access Adaptation. CMS waived the requirement at 42 CFR §494.100(c)(1)(i) that requires periodic monitoring of the patient’s home adaptation, including the need for facility personnel to visit patient homes. The April 21, 2020 guidance clarified a typographical error on the citation from the March 28, 2020 guidance.
- Home Dialysis Machine Designation-Clarification. CMS explained that the ESRD Conditions for Coverage do not require each home dialysis patient to have their own designated home dialysis machine. Dialysis facilities are required to follow U.S. Food and Drug Administration (FDA) labeling requirements and the manufacturer’s directions for use to ensure the dialysis machine and ancillary equipment are operated appropriately, and, if used by multiple patients, that the equipment must be properly cleaned and disinfected to reduce the risk of infection.
- Special Purpose Renal Dialysis Facilities (SPRDF) Designation Expanded. CMS authorized the establishment of SPRDFs under 42 CFR §494.120 to address access to care issues due to COVID-19 and to help mitigate transmission of the disease among this vulnerable population. CMS also clarified that this designation expansion will not include the normal determination regarding lack of access to care provided for under §494.120(b) because the standard has been met during this national emergency. Note that dialysis services may be provided by a SPRDF prior to completion of the survey.
- Dialysis Patient Care Technician (PCT) Certification. CMS modified dialysis PCT certification, set forth at 42 CFR § 494.140(e)(4), to allow PCTs to work even if they have not obtained certification within 18 months of hire or have not satisfied the on-time renewal requirements.
- Transferability of Physician Credentialing. CMS also modified state law credentialing requirements set forth at 42 CFR § 494.180(c), to allow appropriately credentialed physicians at a certified dialysis facility to provide care at designated isolation locations without having to first obtain separate credentialing at these facilities, unless required by a state’s emergency preparedness or pandemic plan.
- Expanding Availability of ESRD to Nursing Home Residents. CMS waived the following requirements related to Nursing Home residents:
- CMS waived the requirement set forth at 42 CFR § 494.180(d) to allow dialysis facilities to provide service to its patients in the nursing home (NF) or skilled nursing facility (SNF), rather than on their main premises. This will be permitted so long as such dialysis services are provided under the direction of the same governing body and professional staff as the residents’ usual Medicare-certified dialysis facility. Additionally, dialysis facility staff must: (i) furnish all dialysis care and services to their patients at the SNF/NF, (ii) provide all equipment and supplies necessary for the dialysis, (iii) maintain the equipment and supplies at the SNF/NF, and (iv) complete all equipment maintenance, cleaning and disinfection using the appropriate infection control procedures and manufacturer’s instructions for use.
- CMS provided specific instructions for the coding and billing of dialysis services furnished to ESRD patients at a SNF/NF. We encourage dialysis facilities to review the Clarification for Billing Procedures provision in the April 21, 2020 guidance for further details on specific codes to be used for such services. In order for the SNF/NF to use a dialysis machine, it must follow FDA labeling requirements, the manufacturer’s directions for use and proper infection control requirements.
- Provider Enrollment. CMS announced toll-free hotlines for all providers and Part A certified providers and suppliers that are establishing isolation facilities to enroll and receive temporary Medicare billing privileges. In its updated April 21, 2020 guidance, CMS clarified that it will waive the following provider enrollment screening requirements: application fee; fingerprint-based criminal background checks; and site visits. CMS also stated that it is (i) postponing all revalidation actions; (ii) allowing licensed providers to render services outside of their state of enrollment; (iii) expediting pending or new applications from providers; (iv) allowing physicians (and other practitioners) to render telehealth services from their home without reporting their home address on their Medicare enrollment while continuing to bill from their currently enrolled location; and (v) allowing opted-out physicians and non-physician practitioners to terminate their opt-out status early and enroll in Medicare to provide care to more patients. Note, in the updated April 21, 2020 guidance, the provider enrollment section is not specific to ESRD facilities, as it was in the March 28, 2020 guidance document.
- Medicare Appeals in Fee for Service, MA and Part D. CMS relaxed the requirements for the Medicare appeals process by allowing Medicare Administrative Contractors (MACs), Qualified Independent Contractors (QICs) and Independent Review Entities (IREs) to: (i) allow extensions to file appeals; (ii) waive timeliness requirements for requests for additional information to adjudicate appeals; (iii) to process appeals with incomplete Appointment of Representation forms; (iv) process requests for appeals by using available information even if the required elements are not satisfied; and (v) otherwise provide all flexibility available in the appeals process as if good cause requirements had been satisfied.
- Notably, the April 21, 2020 guidance omits the statement from the March 28, 2020 guidance allowing Medicare Advantage (MA) plans to extend the timeframe to adjudicate organization determinations and reconsiderations for medical items and services (but not Part B drugs) by up to 14 calendar days if: the enrollee requests the extension; the extension is justified and in the enrollee’s interest due to the need for additional medical evidence from a noncontract provider that may change an MA organization’s decision to deny an item or service; or, the extension is justified due to extraordinary, exigent, or other non-routine circumstances and is in the enrollee’s interest. However, we believe this flexibility is addressed by (v) above.
- We also note that in the updated April 21, 2020 guidance, this section is not specific to ESRD facilities, as it was in the March 28, 2020 guidance document.
- Accelerated/Advance Payment. Per the March 28, 2020 guidance, CMS expanded its Accelerated and Advance Payment Program so that most Medicare Part A and Part B providers and suppliers, including dialysis facilities, could request an advance of their anticipated Medicare payments for a three- or six-month period, depending on the provider category. The Accelerated and Advance Payment Program directs MACs to renew requests and issue payments within a seven-day period. CMS has also extended the time for repayment of these accelerated and advance payments from 90 to 120 days after the date the payment was issued.
- We note that while the April 21, 2020 guidance did not include a specific discussion regarding the Accelerated and Advanced Payment Program, the March 28, 2020 guidance, which included information regarding CMS’ Accelerated and Advance Payment Program, is still available on the CMS website. Although the Accelerated/Advance Payments section is not contemplated in the April 21 guidance, it presumably remains in effect.
- CMS Cost Reporting. CMS delayed the filing deadlines for certain cost report due dates. CMS authorized the delay of filing deadlines for fiscal year end (FYE) October 31, 2019 and FYE November 30, 2019, cost reports until June 30, 2020. CMS also delayed the filing deadline of the FYE December 31, 2019 cost reports until July 31, 2020.
- The April 21, 2020 guidance does not include a discussion regarding the extension regarding cost report filing. Nevertheless, this guidance is set forth in CMS’ March 28, 2020 guidance, which is still available on CMS’ website and presumably remains in effect.
B. Key Takeaways From the Updated Guidance Documents
We previously issued an article on March 19, 2020, examining CMS and CDC recommendations to dialysis facilities regarding infection control to minimize the transmission of COVID-19. Since that article, CMS issued on March 30, 2020, updated recommendations in Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in dialysis facilities (Revised), and CDC issued on April 12, 2020, updated recommendations in Interim Additional Guidance for Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed COVID-19 in Outpatient Hemodialysis Facilities. In this section, we discuss key updates made in the revised guidance recommendations for infection control. For a more comprehensive summary of the current CDC and CMS guidance on infection control, view our Summary of Cumulative Guidance Regarding Infection Control and Prevention of COVID-19 in Dialysis Facilities below.
- Universal Masking
- To combat the potential spread of COVID-19 by asymptomatic individuals, CDC issued a recommendation that the all people wear a cloth face covering whenever they leave their homes.
- Accordingly, the CDC now recommends that anyone entering a health care facility (e.g., health care personnel, patients, visitors), regardless of whether they exhibit COVID-19 symptoms, wear a face covering or mask over the mouth and nose to reduce the risk of COVID-19 transmission via respiratory secretions.
- Medical facemasks offer source control as well as protection for the wearer and are preferred over cloth face coverings for health care personnel whenever available. CDC has issued guidance on strategies to optimize the supply of PPE and equipment should facilities need information regarding the reuse of PPE when supplies are running low or absent. Cloth face coverings are not considered personal protective equipment.
- For visitors and patients of a dialysis facility, a cloth face covering may be appropriate, especially if the facility is experiencing a shortage of facemasks. If a visitor or patient arrives at the dialysis facility without a cloth face covering, a facemask may be used if supplies are available. However, facemasks should be prioritized for health care personnel and patients exhibiting COVID-19 symptoms.
- Managing Visitor Access
- CMS recommends dialysis facilities follow CDC’s guidance to manage visitor access and movement within the dialysis facility. CDC guidance recommends:
- Limiting visitors to only those essential for the patient’s physical or emotional well-being and care.
- Actively assessing all visitors for fever and COVID-19 symptoms upon entry to the facility. If fever or COVID-19 symptoms are present, the visitor should not be allowed entry into the facility.
- Establishing procedures for monitoring, managing, and training all visitors to wear a facemask or cloth face covering at all times while in the facility, perform frequent hand hygiene, and restrict their visit to areas designated by the facility.
- Appropriate Cleaning and Disinfection
- Health care personnel should follow the environmental infection control recommendations established in the CDC’s Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) in Health care Settings. These infection control recommendations include:
- Using dedicated medical equipment when caring for patients with known or suspected COVID-19. All non-dedicated, non-disposable medical equipment used for patient care should be cleaned and disinfected according to manufacturer’s instructions and facility policies.
- Disinfecting or discarding any surface, supplies or equipment (e.g., dialysis machines) located within six feet of symptomatic patients.
- Performing routine cleaning and disinfection procedures appropriate for COVID-19 in health care settings, including in patient-care areas in which aerosol generating procedures are performed. The Environmental Protection Agency (EPA) has provided a list of disinfectants approved for use against COVID-19. When using products from this list, ensure the products also have a bloodborne pathogen claim (e.g., hepatitis B, HIV). Facilities should ensure they are following the manufacturer’s label instructions for proper use and dilution of the disinfectant (e.g., concentration, application method and contract time, etc.).
- Flexibility Within ESRD Program to Address COVID-19 and Alternative Patient Care Models
- Current Medicare law and regulations offer flexibility for ESRD facilities to meet the needs of their patients during a national emergency. The CMS guidance document identifies four patient care delivery models authorized under the federal government’s Section 1135 waiver authority. The patient care delivery models discussed are below and the specific steps to be undertaken to implement such models can be found in our Summary of Cumulative Guidance Regarding Infection Control and Prevention of COVID-19 in Dialysis Facilities.
- Dialysis facilities already certified for Home Training and Support services may consider providing home dialysis services to residents of Long Term Care (LTC) facilities.
- Dialysis facilities may choose to add Home Dialysis Training and Support services to an existing Medicare certified facility.
- Dialysis facilities may establish a Special Purpose Renal Dialysis Facility (SPRDF) under CMS’s current regulatory authority.
- Dialysis facilities may seek approval for program waivers through the 1135 waiver that accompanies the Presidential Declaration of Emergency for COVID-19.
Summary of Cumulative Guidance Regarding Infection Control and Prevention of COVID-19 in Dialysis Facilities
Early Recognition and Isolation of Individuals With Suspected or Confirmed COVID-19
- Health care personnel should be reminded to not report to work when they are ill, and facilities should implement sick leave policies that allow ill personnel to stay home. If any staff member begins to exhibit signs and symptoms of COVID-19 at work, they should immediately stop working, put on a facemask (if they are not wearing one already) and self-isolate. The ill staff member must notify the facility administrator and provide information regarding their contact with persons, equipment and locations in the facility. Prior to allowing the ill staff member to return to work, the facility administrators should review the CDC’s criteria for allowing health care personnel with suspected or confirmed COVID-19 to return to work.
- Facilities are encouraged to screen patients, staff, visitors and home dialysis patients for the following:
- Signs or symptoms of a respiratory infection or COVID-19, such as fever, cough, shortness of breath, sore throat or difficulty breathing.
- Contact in the last 14 days with any person having a confirmed diagnosis of COVID-19, under investigation for COVID-19 or ill with a respiratory infection.
- International travel within the last 14 days to countries with widespread or ongoing community spread.
- Residence in a community where community-based spread of COVID-19 is occurring.
- Staff should ask patients about any fever or respiratory symptoms immediately upon arrival at the facility and should consider checking all patient temperatures. Signs should be posted at clinic entrances with instructions for patients with fever or symptoms of respiratory infection to alert staff so appropriate precautions can be implemented.
- Facilities should identify patients with signs and symptoms of respiratory infection before they enter the treatment area. Patients should be instructed to call ahead to report fever or respiratory symptoms so the facility can be prepared for their arrival or triage them to a more appropriate setting (e.g., an acute care hospital). All patients, regardless of symptoms, should put on a cloth face covering no later than check-in and keep it on until they leave the facility. If patients do not have a cloth face covering, a facemask or cloth face covering should be offered (if supplies allow).
- Facilities should provide patients and health care personnel with instructions (in appropriate languages) about social distancing (e.g., maintaining a distance of at least 6 feet from all other persons whenever possible), hand hygiene, respiratory hygiene and cough etiquette. Facilities should have supplies positioned close to dialysis chairs and nursing stations to ensure adherence to hand and respiratory hygiene and cough etiquette. These include tissues and no-touch receptacles for disposal of tissues and hand hygiene supplies (e.g., alcohol-based hand sanitizer). Facilities should also provide instructions regarding the use of cloth face coverings and facemasks and their proper disposal.
- Visitors with suspected or confirmed COVID-19 should self-quarantine and defer visitation until they are no longer potentially infectious.
Universal Face Masking
- Because of CDC’s recommendation regarding universal face covering, CDC recommends that everyone entering a health care facility (e.g., health care personnel, patients, visitors), regardless of exhibiting COVID-19 symptoms, implement source control. Source control involves wearing a face covering or facemask over one’s mouth and nose to contain respiratory secretions in an effort to reduce the risk of transmission of COVID-19 by both symptomatic and asymptomatic individuals. Updates were also made to CDC’s Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings to address universal source control for everyone in a health care facility, including dialysis facilities.
- Health care personnel should wear a facemask at all times while they are in the health care facility. Cloth face coverings are not considered personal protective equipment because their capability to protect health care personnel is unknown. When available, facemasks are preferred over cloth face coverings for health care personnel, as facemasks offer both source control and protection for the wearer against exposure to splashes and sprays of infectious material from others. CDC has issued guidance regarding the extended use and reuse of facemasks should facilities need strategies or options to optimize supplies of facemasks.
- For visitors and patients of the dialysis facility, a cloth face covering may be appropriate, especially if the facility is experiencing a shortage of facemasks. If a visitor or patient arrives at the dialysis facility without a cloth face covering, a facemask may be used for source control if supplies are available. However, facemasks should be prioritized for health care personnel and then for patients with symptoms of COVID-19, as supply allows.
Treating Ill Patients
- Facilities should seat patients with suspected or confirmed COVID-19 at least six feet from other patients in the waiting room. Patients with suspected or confirmed COVID-19 should be brought back to an appropriate treatment area as soon as possible to minimize time in waiting areas. Medically stable patients without other care needs may be asked to wait in a personal vehicle or outside, and be contacted by phone when ready to be seen.
- Facilities should maintain at least six feet of separation between patients with suspected or confirmed COVID-19, and other patients, during dialysis treatment. It is recommended that symptomatic patients be dialyzed in a separate room (if available) with the door closed. Facilities may use hepatitis B isolation rooms if (a) the patient is hepatitis B surface antigen positive or (b) there are no such patients requiring treatment at the facility. If a separate room is not available, the symptomatic patient with suspected or confirmed COVID-19 should be treated at a corner or end-of-row station, away from the main flow of traffic, and still be separated by at least 6 feet from the nearest patient stations.
- If a facility is dialyzing more than one patient with suspected or confirmed COVID-19, it should consider cohorting those patients and the health care personnel caring for them in the same unit and/or on the same shift (e.g., the last shift of the day). If the etiology of respiratory symptoms is known, patients with different etiologies should not be cohorted (for example, patients with confirmed influenza and COVID-19 should not be cohorted).
- The local health department should be notified about the patient with suspected or confirmed COVID-19, and facilities should follow the CDC guidance regarding infection control for COVID-19 patients.
Personal Protective Equipment and Cleaning Guidelines
- Health care personnel caring for patients with suspected or confirmed COVID-19 should follow the Standard, Contact and Droplet Precautions with eye protection unless the suspected diagnosis requires Airborne Precautions (e.g., tuberculosis) (as each of those Precautions has been further defined by the CDC). This includes the use of: (1) gloves, (2) N-95 or higher-level respirator (or facemask, if a respirator is not available), (3) eye protection (e.g., goggles and a disposable face shield that covers the front and sides of the face) and (4) isolation gown.
- Respirators should be reserved for situations where respiratory protection is most important, such as the performance of procedures generating aerosol particles on patients with suspected or confirmed COVID-19 or caring for patients with other infections for which respiratory protection is strongly indicated (e.g., tuberculosis, measles, varicella).
- In the event of a shortage, gowns should be prioritized for initiating and terminating dialysis treatment, manipulating access needles or catheters, helping the patient into and out of the station, and cleaning and disinfecting patient care equipment and the dialysis station.
- Health care personnel should following the environmental infection control recommendations established in the Interim Infection Prevention and Control Recommendations for Patients with Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings. These environmental infection control recommendations include:
- Dedicated medical equipment should be used when caring for patients with known or suspected COVID-19. All non-dedicated, non-disposable medical equipment used for patient care should be cleaned and disinfected according to manufacturer’s instructions and facility policies. Any surface, supplies or equipment (e.g., dialysis machines) located within six feet of symptomatic patients should be disinfected or discarded.
- Facilities should ensure that environmental cleaning and disinfection procedures are followed consistently and correctly and provide training to its staff on those procedures. Routine disinfection of the station should be performed without the patient present. If visible blood or other soil is present, surfaces must be cleaned prior to disinfection.
- Facilities should ensure that all routine cleaning and disinfection procedures (e.g., using cleaners and water to pre-clean surfaces prior to applying an EPA-registered, hospital-grade disinfectant to frequently touched surfaces or objects for appropriate contact times as indicated on the product’s label) are appropriate for COVID-19 in health care settings, including those patient-care areas in which aerosol-generating procedures are performed. The EPA has provided a list of disinfectants approved for use against COVID-19. When using products from this list, ensure the products also have a bloodborne pathogen claim (e.g., hepatitis B, HIV). Facilities should ensure they are following the manufacturer’s label instructions for proper use and dilution of the disinfectant (e.g. concentration, application method and contract time, etc.).
- Facilities should also provide additional work supplies to avoid sharing (e.g., pens, pads) and disinfect workplace areas (e.g., nurse’s stations, phones, etc.).
Managing Visitor Access
- Limit visitors to the facility to only those essential for the patient’s physical or emotional well-being and care (e.g., care partners).
- Actively assess all visitors for fever and COVID-19 symptoms upon entry to the facility. Visitors with fever or COVID-19 symptoms should not be allowed into the facility.
- Establish procedures for monitoring, managing and training all visitors, including instructions to wear a facemask or cloth face covering at all times while in the facility, perform frequent hand hygiene, and restrict their visit to areas designated by the facility.
Transferring COVID-19 Patients to Alternative Sites
- Dialysis facilities should consider transferring symptomatic and/or COVID-19 positive patients to another treatment site if the facility cannot fully implement the recommended precautions. Transport personnel and the receiving facility should be notified of the patient’s health care needs in advance, and the patient should wear a facemask and remain separated from other patients while awaiting transfer.
Special Considerations for Home Dialysis
- Dialysis facilities should continue to provide monthly monitoring of home dialysis patients onsite at the facility. While it is important to limit potential COVID-19 exposure for home dialysis patients, it is also important that these patients do not miss their onsite appointments, during which staff can confirm that home dialysis patients are following safety procedures required to ensure a safe home dialysis environment. The same screening precautions for in-center dialysis patients and visitors should also apply to any home dialysis patient who comes into the facility for treatment.
Alternative Patient Care Delivery Models
- Dialysis facilities already certified for Home Training and Support services may consider providing home dialysis services to residents of Long-Term Care (LTC) facilities in agreement with the patient’s nephrologist and patient or patient representative. Since such dialysis facilities are already certified to provide home dialysis services, adding home dialysis in a LTC facility only requires a dialysis facility to notify the designated State Agency via the CMS- Form 3427. No additional approval or survey will be necessary in this instance.
- Dialysis facilities may choose to add Home Dialysis Training and Support services to an existing Medicare certified facility. In order to do so, a dialysis facility will need to:
- Submit a Medicare Enrollment Application (CMS Form 855A).
- Submit an End Stage Renal Disease (ESRD) Application (CMS-Form 3427) and Survey and Certification Report to its designated State Agency (SA).
- For approval of each home dialysis modality for which a dialysis facility is applying, at least one patient (and/or the patient’s caregiver) on census who has been or is being trained by that dialysis facility.
- Demonstrate compliance with the ESRD Conditions of Coverage, validated by an onsite survey conducted by the designated SA or CMS approved Accreditation Organization.
- Establish a Special Purpose Renal Dialysis Facility (SPRDF) under CMS’s current regulatory authority, with additional information regarding SPRDFs located in the State Operations Manual, Chapter 2, section 2272. Dialysis facilities may apply for SPRDF certification if: (a) COVID-19 is identified in the facility’s geographic area and presents an access to care issue or (b) a dialysis facility has symptomatic patients and must cohort such symptomatic patients in order to limit exposure. A SPRDF certification cannot exceed 8 months within any 12-month period, after which there must be a plan for the safe transfer of patients to a permanent outpatient setting. Before a SPRDF can provide dialysis services to patients, it must undergo the following process:
- Submit a Medicare Enrollment Application (CMS Form 855A).
- Submit an End Stage Renal Disease (ESRD) Application (CMS-Form 3427) to the respective CMS Location.
- Obtain all state requirements (e.g., state license to operate, certificate of need, etc.).
- Undergo a federal survey within the approved time period of special purpose designation (typically eight months). Note that dialysis services may be provided prior to completion of the survey.
- Seek approval for program waivers through the 1135 waiver that accompanies the Presidential Declaration of Emergency for COVID-19. These requests should be made to the CMS Location Office. Section 1135 waivers allow the Secretary of the Department of the Health and Human Services (HHS) to temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure that sufficient health care items and services are available to meet the needs of individuals in emergency areas and time periods, and that providers who provide such services in good faith can be reimbursed and exempted from sanctions (absent any determination of fraud or abuse).