The Centers for Medicare and Medicaid Services (CMS) recently provided Section 1135 waivers and guidance granting flexibilities to home health agencies (HHAs) and hospices during the Coronavirus (COVID-19) pandemic national emergency.

Of note are an expanded ability for HHAs and hospices to provide some telehealth services to Medicare beneficiaries as well as the easing of certain administrative requirements for determination and certification of eligibility for Medicare patients to receive home health and hospice services. Like other Medicare providers, HHAs and hospices are also eligible for accelerated/advanced payments from Medicare, and HHAs may be able to utilize the blanket Stark Law waivers for COVID-19-related purposes.

IN DEPTH

Background

On March 13, 2020, President Donald Trump declared a national emergency under the National Emergencies Act and made an emergency determination under the Stafford Act. This announcement followed the January 31, 2020, declaration of a public health emergency under the Public Health Service Act by the Secretary of the US Department of Health and Human Services (HHS). These actions opened the door for the authorization of waivers of certain Medicare, Medicaid and Children’s Health Insurance Program (CHIP) requirements as provided by Section 1135 of the Act (collectively, Section 1135 waivers).

Section 1135 of the Act allows the Secretary to temporarily waive certain, but not all, healthcare regulatory requirements in an emergency area during an emergency period. To implement Section 1135 waivers, CMS must determine that a provider has been affected by the emergency that prompted the issuance of the waivers. CMS has the option to issue individual Section 1135 waivers on a case-by-case basis, or CMS can implement “blanket” waivers.

Section 1135 waivers typically end either at the termination of the emergency period or 60 days from the date that the waiver or modification is published. With notice, HHS may provide for additional periods of up to 60 days until the end of the emergency period. For more information on Section 1135 waivers, see our previous On the Subject.

In Depth

HHAs and hospice providers play an important role in caring for patients in the home setting. The COVID-19 pandemic has created new challenges for HHAs and hospices operating in these settings, in particular due to widespread quarantines, remote work and provider shortages. CMS has issued Section 1135 waivers and guidance in the form of fact sheets for HHAs and hospices that detail flexibilities afforded to HHAs and hospice providers during the public health emergency.

1. Home Health Agencies

Changes to “Homebound Status”

CMS has temporarily revised the definition of “homebound” to include Medicare patients for whom: (1) a physician has determined it is medically necessary for that patient to remain home because he/she has been diagnosed with COVID-19; or (2) a physician has determined that is it medically necessary for the patient to remain home because he/she has a condition that may make the patient more susceptible to contracting COVID-19.

Because the CDC is advising older adults to remain home during the outbreak, CMS expects that this will render a large number of Medicare beneficiaries “homebound.” However, a physician’s certification in the patient’s medical record is essential; self-quarantine or social distancing alone is not sufficient to render a Medicare patient “homebound” for this purpose. Under the new telehealth waiver, CMS will allow the face-to-face encounter with a physician or an allowed non-physician practitioner to be performed via telehealth to the patient’s home or other originating site. As noted in the next section, initial assessments can be conducted by the HHA remotely or by record review. CMS notes in the Interim Final Rule (IFC) that this clarification is not limited to the COVID-19 pandemic, but could apply to other outbreaks of infectious disease, and solicits comments to that point.

Initial Assessments; OASIS Reporting

CMS has also waived the requirement that HHAs perform initial assessment visits with Medicare beneficiaries to determine eligibility for the benefit and the patient’s homebound status. This initial assessment can now be conducted remotely or by record review by the HHA. CMS indicates that this will make available scarce physicians and advanced practice clinicians and enable them to provide direct patient care rather than focusing on administrative tasks.

CMS has also permitted occupational therapists (OTs) to perform initial and comprehensive assessments for all Medicare patients receiving occupational therapy as part of the plan of care, regardless of whether occupational therapy is the service that establishes eligibility for care. OTs can only perform this assessment when occupational therapy is part of the plan of care; OTs and other therapists are not permitted to perform the assessment in nursing-only cases. OTs must only perform the assessment if it is within their state scope of practice laws and must access other professionals (e.g., nurses) for portions of the assessment outside of their scope of practice.

Additionally, CMS has extended timeframes for HHAs to report via CMS’ Outcome and Assessment Information Set (OASIS). The waiver extends the 5-day completion requirement for the comprehensive assessment and waives the 30-day OASIS submission requirement. CMS will continue to require that HHAs assess patients to determine and appropriately meet their care needs; HHAs are expected to complete the comprehensive assessment within 30 days, and delayed submission is permitted during the public health emergency.

Telehealth

CMS reiterated that it is statutorily prohibited from paying for home health services furnished via telecommunications if those telehealth services are provided in lieu of in-person home health services ordered as part of the Medicare patient’s plan of care. During the public health emergency, however, CMS is temporarily allowing HHAs to use telehealth—in addition to remote monitoring—to provide services to patients, but only if the use of technology is related to the skilled services being furnished by a nurse, therapist or therapy assistant to optimize the services furnished during the home visit or when there is a home visit. For the purposes of Medicare payment, the plan of care must include a description of how the use of the technology will help achieve goals in the plan of care without substituting for in-person visits ordered in the plan of care. Services provided via telemedicine cannot be considered a home visit for the purposes of patient eligibility or payment, but HHAs can report the costs of telecommunication technology as allowable administrative and general costs on an interim basis.

Plans of Care; Certifying and Recertifying Eligibility; Onsite Supervision

In light of potential workforce shortages due to the public health emergency, CMS will temporarily allow Medicare patients to be under the care of a nurse practitioner (NP), clinical nurse specialist (masters-level RN) or a physician assistant (PA) who is working in accordance with state law and permits such practitioner to: (1) order home health services; (2) establish and periodically review a plan of care for home health services (e.g., sign the plan of care); and (3) certify and re-certify that the patient is eligible for Medicare home health services. HHAs utilizing these providers will need to ensure that such providers are working within the scope of their practice under applicable state laws.

CMS has also waived the requirements for registered nurses to conduct onsite visits every two weeks, including the requirement to conduct an onsite visit to evaluate if home health aides are providing care to Medicare beneficiaries consistent with the care plan. Virtual supervision of home health aides is encouraged by CMS, but is not further described or defined in the waiver.

Medicaid Home Health Services

The IFC also amends the state Medicaid home health regulations to permit licensed practitioners other than physicians to order home health services during the COVID-19 public health emergency. Other practitioners, such as NPs and PAs, can order these services for Medicaid beneficiaries so long as they are ordered by the licensed practitioner in accordance with his/her state scope of practice laws. HHAs will need to review these requirements on a state-by-state basis to ensure that the licensed practitioner ordering this service is working within his/her scope of practice. This waiver is intended to align Medicaid’s rules with what is permitted by Medicare and will not expand the benefit categories where these items can be covered.

2. Hospices

Telehealth

For the duration of the public health emergency, CMS will permit hospice providers to provide services via telecommunications to Medicare beneficiaries who are receiving routine home care, but only if it is feasible and appropriate to do so in order for those beneficiaries to continue to receive services without jeopardizing the patient’s health or the health of those who are providing services. According to the IFC, the use of technology to provide those services must be included in the hospice plan of care and must be tied to patient-specific needs identified in the comprehensive assessment. No payment beyond the hospice per diem rate is provided—only in-person visits (other than social work phone calls) should be reported on the claim—but CMS does permit hospices to report the cost of telecommunications technology to furnish services as “other patient care services” as a specific COVID-19 cost center.

Also, face-to-face encounters for purposes of patient recertification for the Medicare hospice benefit can now be conducted by the hospice physician or NP via telecommunications technology during the COVID-19 public health emergency. This face-to-face encounter is an administrative encounter only. The telecommunications technology used as part of the encounter means, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant-site hospice physician or NP.

Waiver of Volunteer, Non-Core and Supervisory Requirements

During the COVID-19 national emergency, CMS has waived certain requirements for hospices: (1) to use volunteers (including at least 5% of patient-care hours); (2) to provide certain non-core hospice services, including physical therapy, occupational therapy and speech-language therapy; and (3) to require a nurse to conduct onsite supervisory visits every two weeks, including the requirement to conduct an onsite visit to evaluate if hospice aides are providing care consistent with the care plan. CMS has acknowledged that these may not be physically possible for hospices to implement during widespread quarantine and stay-home orders.

Comprehensive Assessments

CMS has also temporarily changed required timeframes to update the patient-specific comprehensive assessment that identifies the patient’s need for hospice care and services for the duration of the COVID-19 national emergency. These must be completed as frequently as the condition of the patient allows, but no less frequently than every 21 days (up from every 15 days). An initial assessment must still be conducted within five days after the election of hospice care consistent with the Medicare Conditions of Participation.

Hospice Aides

CMS is temporarily relaxing certain requirements for hospice aide training and competency testing. First, CMS is waiving the requirement for hospices to assure that each hospice aide receives 12 hours of in-service training in a 12-month period. Second, CMS is temporarily allowing a hospice aide to use “pseudo-patients” (such as a computer-based mannequin or person trained to participate in a role-play situation) in competency training of certain tasks that must be observed being performed on a patient.

3. Other CMS Post-Acute Guidance and Resources:

• Advanced/Accelerated Payment: Post-Acute Providers who qualify are eligible for increased cash flow under Medicare’s Accelerated and Advance Payment Program. For more information regarding the qualifications for this program, see McDermott’s On the Subject article here.

• Stark Law Waivers/HHS, Office of Inspector General (OIG) Enforcement: CMS has provided 18 blanket waivers that will apply to arrangements in which a designated health services entity (DHS Entity), such as a home health agency, conveys a benefit directly to a physician or an immediate family member of a physician, or in which a physician (or immediate family member) conveys a benefit directly to a DHS Entity, so long as a COVID-19 purpose is met. The OIG issued a Policy Statement on April 3, 2020, indicating that it will not seek to impose administrative sanctions for arrangements protected under certain of the Stark Law blanket waivers. For more information, see McDermott’s On the Subject article here.

• Infection Control and Prevention Guidance: CMS has also issued Quality, Safety, and Oversight guidance regarding infection control and prevention for patients in the home care setting, for both HHAs and hospice agencies.

• Delay in Cost Reporting; Waiver of Quality Reporting Requirements: CMS has authorized delay of filing of Cost Reports. CMS will delay the filing deadline for October and November fiscal year end (FYE) cost reports until June 30, 2020, and the deadline for December FYE cost reports is extended until July 31, 2020.

• Waiver of Quality Reporting Requirements: Additionally, CMS has relaxed requirements under quality reporting programs. Home Health and Hospice Quality Reporting Programs deadlines for Q4 2019 data (October 2019–December 2019) are now optional. Consumer Assessment of Healthcare Providers & Systems (CAHPS) data from Q1–Q3 2020 (January 2020 through September 2020) does not need to be submitted to CMS.

• Suspension of Survey and Certification Activity; Revalidation: CMS is suspending all non-emergency survey inspections, and survey efforts are focused on immediate jeopardy events and complaints regarding infection control concerns. Finally, CMS is also temporarily ceasing revalidation efforts for all Medicare providers and suppliers during the COVID-19 public health emergency.