On March 28, 2020, the Centers for Medicare & Medicaid Services (CMS) announced it was providing additional flexibility to end-stage renal disease (ESRD) facilities under the Medicare conditions for coverage at 42 CFR §§ 494.1 et seq. during the COVID-19 national emergency.
Waived requirements include those related to 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.
Patients Over Paperwork
- Training Program and Periodic Audits. CMS is waiving the requirement for periodic audits of operators of water/dialysate equipment, set forth at 42 CFR § 494.40(d) and related to the condition on water and dialysate quality.
- Equipment Maintenance & Fire Safety Inspections. CMS is waiving the inspection requirements set forth at 42 CFR §§ 494.60(b) & (d) to reduce the number of non-essential people entering a dialysis facility, to curtail the risk of exposure to COVID-19.
- Emergency Preparedness. CMS is waiving the requirement for the maintenance of CPR certification by patient care staff, set forth at 42 CFR § 494.62(d)(iv), during the COVID-19 emergency, due to the limited availability of CPR classes.
- Ability to Delay Some Patient Assessments. CMS is waiving the “on-time” requirements set forth at 42 CFR §§ 494.80(b)(1) & (2) for:
- the initial comprehensive assessment of all new patients within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session, and
- follow-up comprehensive reassessments within three months after the completion of the initial assessment.
CMS continues to expect dialysis facilities to conduct the patient assessment, ensure the adequacy of the dialysis treatment and assess the patient’s needs when there is a change in condition.
- Multi-patient Use of Home Dialysis Machines. CMS clarified that dialysis facilities are not required, by the CFCs, to provide each home dialysis patient with his or her own designated dialysis machine. However, if such machines are used to treat multiple patients (e.g., at a nursing home), shared use must be permitted by FDA labeling and the manufacturer’s directions for use. In addition, if used to treat multiple patients, a dialysis machine must be properly cleaned and disinfected to minimize the risk of infection in accordance with 42 CFR § 494.30. This represents a significant change from CMS’ longstanding and repeatedly articulated position that each dialysis patient must have his or her own dedicated dialysis machine.
Telehealth for ESRD Medicare Beneficiaries
During the COVID-19 national emergency, CMS is waiving the following requirements with respect to ESRD beneficiaries in order to facilitate care via telehealth.
- Time period for initiation of care planning and monthly physician visits. CMS is waiving the following timing requirements:
- The plan of care implementation requirement set forth at 42 CFR § 494.90(b)(2), which requires the dialysis facility to (i) implement the 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 (ii) update the plan monthly or annually within 15 days of the completion of additional patient assessments.
- The monthly in-person visit requirement set forth at 42 CFR § 494.90(b)(4) if the patient is considered stable. CMS recommends that dialysis facilities utilize telehealth capabilities to ensure patient safety in the absence of such visits.
- Dialysis home visits to assess adaptation. CMS is also waiving the requirement for dialysis facilities to periodically monitor a patient’s home adaptation, including through visits to the patient’s home by facility personnel, which is set forth at 42 CFR § 494.100(c)(i).
Dialysis Facilities Without Walls (Temporary Expansion Sites)
To ensure that dialysis facilities have the capacity to handle a potential surge of COVID-19 patients through temporary expansion sites, CMS announced the following:
- Special purpose renal dialysis facilities (SPRDF) designation expanded. CMS authorized the establishment of SPRDFs to address access-to-care issues due to COVID-19 and the need to mitigate transmission among this vulnerable population. SPRDF approval will not require the completion of a federal survey prior to providing services. In addition, during the national emergency, the requirement for a determination regarding lack of access to care shall be deemed to have been met. Depending on the state in which the SPRDF is located, state licensure and CON requirements may still apply to the establishment of an SPRDF.
- Furnishing dialysis services off the main premises. CMS is waiving the requirement, set forth at 42 CFR § 494.180(d), for dialysis facilities to provide services directly on their main premises or premises contiguous with the main premises. Also during the COVID-19 national emergency, dialysis facilities are allowed to provide services to their patients in skilled nursing facilities or nursing homes (SNFs/NFs). Dialysis services for nursing home residents must be provided under the direction of the same governing body and professional staff as the residents’ usual Medicare-certified dialysis facility. In addition, dialysis facility staff, as opposed to the staff of the SNF/NF, 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 (v) complete all equipment maintenance, cleaning and disinfection using the appropriate infection control procedures and manufacturer’s instructions for use.
- Clarification of billing procedures. In the announcement, CMS provides specific instructions for the coding and billing of dialysis services furnished to ESRD patients at an SNF/NF.
CMS announced new toll-free hotlines for all providers and Part A certified providers and suppliers establishing isolation facilities to enroll and receive temporary Medicare billing privileges. CMS has also relaxed the enrollment procedures by (i) waiving certain screening requirements, (ii) postponing all revalidation actions, and (iii) expediting any pending or new applications from providers.
To remove barriers to the hiring of physicians and other clinicians so dialysis facilities have the capacity to handle a potential surge of COVID-19 patients, CMS indicated it was relaxing the following licensure and credentialing requirements:
- Waiver of Dialysis Patient Care Technician Certification. Due to limited availability and closures of testing sites during the national emergency, CMS is modifying the certification requirement, set forth at 42 CFR § 494.140(e)(4), to allow patient care technicians to continue working even if they have not obtained certification within 18 months of being hired or have not satisfied on-time renewal requirements. Depending on the state in which the dialysis facility is located, state licensure and certification requirements may still apply to patient care technicians.
- Waiver of State Law Credentialing Requirements. CMS is modifying the requirement, set forth at 42 CFR § 494.180(c)(1), for medical staff to be appointed and credentialed in accordance with state law. Specifically, CMS will allow physicians that are appropriately credentialed at a certified dialysis facility to provide care at either designated isolation locations or COVID-19-only facilities without obtaining separate credentialing at such facilities, except to the extent prohibited by a state’s emergency preparedness or pandemic plan.
Cost Reporting Deadline Delay
Due to the strain on healthcare providers caused by the COVID-19 pandemic, CMS is delaying the filing deadlines for FYE 10/31/2019 and FYE 11/30/2019 cost reports until June 30, 2020, and for FYE 12/31/2019 cost reports until July 31, 2020.
Accelerated/Advance Medicare Payments
As described in more detail in a previous McGuireWoods alert, on March 28, 2020, CMS released guidance expanding its Accelerated and Advanced Payment Program to enable most Medicare Part A and Part B providers and suppliers, including dialysis facilities, to request an advance of up to 100 percent or more of their anticipated Medicare payments for a three- or six-month period, depending on the provider category. Under the program, Medicare Administrative Contractors (MACs) are directed to review requests and issue payments within a seven-day period, and CMS has extended the time for repayment of these advance/accelerated payments from 90 to 120 days after the date of issuance of the payment.
Medicare Appeals Processes in Medicare Fee for Service, Medicare Advantage and Medicare Part D
Under this category, CMS is relaxing the requirements for the Medicare appeals process by allowing MACs, qualified independent contractors and independent review entities, in their respective programs, to: (i) allow extensions to file an appeal; (ii) waive timeliness requirements for requests for additional information to adjudicate appeals; (iii) process appeals with incomplete appointment of representation forms (correspondence will be sent only to the beneficiary); (iv) process requests for appeals by using available information even if they don’t satisfy the required elements; and (v) provide all flexibility available in the appeal process as if good cause requirements were satisfied.
As the COVID-19 national emergency continues to evolve, CMS has encouraged all dialysis facilities and other healthcare providers to monitor the Centers for Disease Control & Prevention website for up-to-date information and resources and to contact local health departments when needed. Please contact the authors of this alert for additional guidance on how other COVID-19 considerations may impact healthcare providers. McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial coronavirus-related business and legal issues.