On Friday, March 13, 2020, the Department of Health and Human Services (HHS) announced several waivers of existing Centers for Medicare and Medicaid (CMS) regulations pursuant to Section 1135(b) of the Social Security Act, including the waiver of certain Emergency Medical Treatment and Active Labor Act (EMTALA) obligations and Medicare conditions of participation during the COVID-19 pandemic. Additionally, HHS waived sanctions and penalties arising from noncompliance with several HIPAA regulatory requirements.

EMTALA Waiver and Other Implications

Secretary Alex Azar of HHS announced the waiver of sanctions under EMTALA[1]. Generally, EMTALA requires Medicare-participating hospitals and critical access hospitals (CAH) that have a dedicated emergency room to, at a minimum, do the following:

• Provide a medical screening exam (MSE) to every individual who comes to the emergency department for examination or treatment for a medical condition to determine if they have an emergency medical condition (EMC). An EMC is present when there are acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in serious impairment or dysfunction;

• Provide necessary stabilizing treatment for individuals with an EMC within the hospital’s capability and capacity; and
  
  
• Provide for transfers of individuals with EMCs, when appropriate.
  
  

Under the EMTALA waiver, hospitals will not be sanctioned during the State of Emergency for: (1) not performing an MSE at the hospital emergency department and directing a patient from a hospital emergency department to another location (this would be an off-campus, non-hospital location) to receive the MSE, but only if that other location was set up pursuant to an appropriate state emergency preparedness plan and (2) transferring a person who has not been stabilized (under circumstances EMTALA would otherwise prohibit) if the “transfer is necessitated by the circumstances of the declared Federal public health emergency for the COVID-19 pandemic.”

Prior to the declaration of a State of Emergency, on March 9, 2020, the CMS Quality, Safety and Oversight Group (“QSO”) issued a memorandum, QSO-20-15, providing guidance to health care providers related to EMTALA implications during the COVID-19 pandemic.

The first EMTALA implication that CMS addressed in the QSO-20-15 guidance is hospitals with capacity, and the specialized capabilities needed for stabilizing treatment for patients with suspected or confirmed COVID-19, are required to accept appropriate transfers from small or rural hospitals that do not have appropriate or sufficient isolation facilities. CMS suggests hospitals should coordinate with their state/local public health officials regarding appropriate placement of individuals who meet specified COVID-19 assessment criteria and the most current standards of practice for treating individuals with confirmed COVID-19 infection status.

CMS stated that to determine if a violation of these EMTALA obligations under the COVID-19 pandemic had occurred, CMS will evaluate both the capabilities and capacity of both the referring and recipient hospitals. Among other things, CMS will take into account the Centers for Disease Control (CDC) recommendations at the time of the event in question when assessing whether a hospital had the requisite capabilities and capacity. CMS noted the CDC recommendations focus on factors – such as the individual’s recent travel or exposure history and presenting signs and symptoms – in differentiating among the capabilities hospitals should have to screen and treat an individual. According to CMS, the presence or absence of negative pressure rooms, known as Airborne Infection Isolation Room (AIIR, will not be the sole determining factor related to transferring patients from one setting to another.

Another EMTALA implication addressed by CMS in the QSO-20-15 guidance is all Medicare-participating hospitals with specialized capabilities are required to accept appropriate transfers of individuals with EMCs if the hospital has the specialized capabilities an individual requires for stabilization, as well as the capacity to treat these individuals. The recipient hospital obligation applies regardless of whether the hospital has a dedicated emergency department.

The full QSO-20-15 guidance is available here.

Waivers and Flexibilities for Hospitals and other Health Care Facilities

CMS has temporarily waived or modified certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements for the following providers and health care facilities during the COVID-19 pandemic:

• Skilled Nursing Facilities (SNF) CMS waived the requirement for a threeday prior hospitalization for coverage of an SNF- stay and is providing temporary emergency coverage of SNF services without a qualifying hospital stay for those people who need to be transferred as a result of the effect of a disaster or emergency. In addition, for certain beneficiaries who recently exhausted their SNF benefits, the waiver authorizes renewed SNF coverage without first having to start a new benefit period. , CMS is also waiving the 42 C.F.R. 483.20 requirements related to the timeframe requirements for Minimum Data Set assessments and transmission.

• Critical Access Hospitals CMS has waived the requirements critical access hospitals limit the number of beds to 25 and the length of stay be limited to 96 hours.

• Housing Acute Care Patients in Excluded Distinct Part Units CMS has waived existing requirements to allow acute care hospitals to house acute care inpatients in excluded distinct part units when the distinct part unit’s beds are appropriate for acute care inpatient. Under the Inpatient Prospective Payment System (IPPS), CMS has indicated the acute care hospital should bill for the care and annotate the patient’s medical record to indicate the patient is an acute care inpatient being housed in the excluded unit because of capacity issues related to the disaster or emergency.

• Durable Medical Equipment CMS has granted Medicare contractors the ability to waive replacement requirements related to situations where Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) are lost, destroyed, irreparably damaged, or otherwise rendered unusable. Medicare contractors have the flexibility to waive replacement requirements, such that the face-to-face requirement, a new physician’s order, and new medical necessity documentation are not required during the pandemic. DMEPOS suppliers must still include a narrative description on the claim explaining the reason why the equipment must be replaced, and they’rethey are reminded to maintain documentation indicating the DMEPOS was lost, destroyed, irreparably damaged, or otherwise rendered unusable or unavailable as a result of the emergency.

• Care for Excluded Inpatient Psychiatric Unit Patients in the Acute Care Unit of a Hospital. CMS is waiving existing requirements to allow acute care hospitals with excluded distinct part inpatient psychiatric units that, as a result of a disaster or emergency, need to relocate inpatients from the excluded distinct part psychiatric unit to an acute care bed and unit. According to CMS, the hospital should continue to bill for inpatient psychiatric services under the Inpatient Psychiatric Facility Prospective Payment System for such patients and annotate the medical record to indicate the patient is a psychiatric inpatient being cared for in an acute care bed because of capacity or other exigent circumstances related to COVID-19. This waiver may be utilized when the hospital’s acute care beds are appropriate for psychiatric patients and the staff and environment are conducive to safe care. For psychiatric patients this includes assessment of the acute care bed and unit location to ensure those patients at risk of harm to self and others are safely cared for.

In addition, CMS is waiving existing requirements to allow Inpatient Rehabilitation Facilities (IRF”) to exclude patients from the hospital’s or unit’s inpatient population for purposes of calculating the applicable thresholds associated with the requirements to receive payment as an IRF ( “60 percent rule”) if an IRF admits a patient solely to respond to the emergency and the patient’s medical record properly identifies the patient as such. In addition, during the applicable waiver time period, CMS will also apply the exception to facilities not yet classified as IRF but are attempting to obtain classification.

• Supporting Care for Patients in Long-Term Care Acute Hospitals (LTCH) This waiver allows a LTCH to exclude from the 25-day average length of stay requirement those patient-stays in which an LTCH admits or discharges patients to meet the demands of the emergency.

• Home Health Agencies This waiver provides relief to home health agencies on the timeframes related to OASIS Transmission of data, which is usually required as a Medicare condition of participation for such agencies. This also allows Medicare administrative contractors to extend the auto-cancellation date of Requests for Anticipated Payment (RAP) during emergencies.

Provider Enrollment Flexibilities

During the pandemic, CMS will temporarily suspend certain Medicare enrollment screening requirements, including site visits and fingerprinting for non-certified Part B suppliers, physicians, and non-physician practitioners. In addition CMS will allow licensed providers to render services outside their state of enrollment. CMS will also establish a toll-free hotline for providers to enroll and receive temporary Medicare billing privileges.

Suspension of Enforcement Activities

CMS will temporarily suspend non-emergency survey inspections, allowing providers to focus on the most current serious health and safety threats, like infectious diseases and abuse.

Medicare Appeals in Fee for Service, Medicare Advantage Claims, and Part D

CMS has also issued the following waivers regarding Medicare appeals:

• Extending the time to file an appeal;
• Waiving the timeliness requirements for requests for additional information to adjudicate the appeal;
• Processing the appeal even with incomplete appointment of representation forms, instead communicating only to the beneficiary;
• Processing requests for appeal that don’t meet the required elements using information available; and
• Utilizing all flexibilities available in the appeal process as if good-cause requirements are satisfied.

Flexibility and Relief for State Medicaid Agencies

The national emergency declaration also enables CMS to grant state and territorial Medicaid agencies a wider range of flexibilities under section 1135 waivers. States and territories are now encouraged to assess their needs and request these available flexibilities, which are outlined in the Medicaid and CHIP Disaster Response Toolkit. Examples of flexibilities available to states under section 1135 waivers include the ability to permit out-of-state providers to render services, temporarily suspend certain provider enrollment and revalidation requirements to promote access to care, allow providers to provide care in alternative settings, waive prior authorization requirements, and temporarily suspend certain pre-admission and annual screenings for nursing home residents. For more information CMS encourages providers to review the Disaster Response Toolkit available here.

The CMS press release announcing these waivers is available here. A CMS factsheet for providers highlighting these waivers is available here.

Waiver of Health Insurance Portability and Accountability (HIPAA) Sanctions and Penalties

HHS has also waived sanctions and penalties arising from noncompliance with the following HIPAA privacy regulatory provisions: (a) the requirements to obtain a patient’s agreement to speak with family members or friends or to honor a patient’s request to opt out of the facility directory (as set forth in 45 C.F.R. § 164.510); (b) the requirement to distribute a notice of privacy practices (as set forth in 45 C.F.R. § 164.520); and (c) the requirement that a patient has a right to request privacy restrictions or confidential communications (as set forth in 45 C.F.R. § 164.522). These waivers only apply to hospitals in the designated geographic area that have hospital disaster protocols in operation during the time the waiver is in effect and for a period not to exceed 72 hours beginning upon implementation of the hospital disaster protocol.

These waivers are expected to be in place during the COVID-19 pandemic. The full HHS waiver can be accessed here.

If you have any questions regarding these waivers issued by CMS during the national emergency for the COVID-19 pandemic or you require assistance with any related matters, please contact your Dinsmore health care attorney.