MAC’s unclear about CMS Enrollment process for licensed independent freestanding EDs

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licensed independent freestanding ed

On 04/21/2020, the Centers for Medicare and Medicaid Services (CMS) has provided the needed flexibility to hospitals to ensure they have the ability to expand capacity and to treat patients during the COVID-19 Public Health Emergency (PHE).

Independent freestanding EDs, which have no hospital affiliation and are specifically licensed by the state to operate independently to provide emergency services, have been identified as a critical resource to assist in expanding capacity for inpatient and outpatient hospital services for patients requiring a higher level of care. Currently, only four states license independent freestanding EDs to operate without hospital affiliation Colorado, Delaware, Rhode Island, and Texas.

Licensed independent freestanding EDs may participate in Medicare and Medicaid to help address the urgent need to increase hospital capacity to provide additional care to patients in the following ways:

• As hospital-affiliated ED under the 1135 emergency waiver;
• As Medicaid-certified clinics under the state’s clinic benefit; and
• As a Medicare-certified hospital by temporarily enrolling in Medicare as a hospital with the attestation process described below, under the 1135 emergency waiver

Different MAC’s (Medicare Administrative Contractors) are still unclear about the recent update in which CMS has provided the needed flexibility to enroll Independent freestanding EDs as temporary hospitals.

In a recent update, CMS has provided the following Enrollment and Attestation guide.

Enrollment Process:

1- A licensed independent freestanding ED seeking to enroll as a temporary hospital during the COVID-19 PHE must submit its intent to the Medicare Administrative Contractor (MAC) that serves its jurisdiction by calling the MAC’s provider enrollment hotline.
2- The licensed independent freestanding ED will be asked by the MAC to submit a signed attestation statement (attached) to the MAC that it meets all federal participation requirements for hospitals, to the extent they are not waived.
3- The MAC will review and forward the ED’s signed attestation statement to the CMS Regional Location mailbox, consistent with normal processes for hospital certification for further review.
CMS Regional Location will:
• Review and approve, if appropriate, the completed attestation statement.
• Create a temporary new facility profile and certification kit in the Automated Survey Process Environment (ASPEN) and assign a trackable hospital CMS Certification Number (CCN)
and
• Send a tie-in notice as a hospital to the MAC. The effective date is the date when the attestation was accepted by the MAC.
*Note: An onsite survey is not required for approval. However, the CMS Regional Location has the discretion to authorize a survey by the State Survey Agency at a later date to ensure quality and safety. If survey activity is warranted, it will be a focused infection control survey-based.

Attestation Requirements:

A licensed independent freestanding ED choosing to enroll as a hospital during the COVID-19 PHE must initially meet and continue to meet the Medicare hospital Conditions of Participation, to the extent not waived, and would receive hospital payments from Medicare based on the care provided.
The licensed independent ED enrolled as a hospital will be required to provide a Medicare Outpatient Observation Notice (MOON) (CMS-10611) to all Medicare beneficiaries, including, when applicable, Medicare Advantage enrollees informing beneficiaries that they are outpatients receiving observation services and are not inpatients of the hospital.
Licensed independent freestanding ED’s Governing Body attests that the entity meets and will continue to meet, during the PHE, all applicable federal participation requirements for hospitals and that the following safeguards are in place.
To the extent not waived, the Licensed Independent Freestanding ED named above is compliant with the requirements of 42 CFR 482.23 Condition of Participation:
Nursing  Services. In particular, but not limited to:
• Ensure adequate numbers of licensed registered nurses and other personnel to provide nursing care to all patients as needed.
• Provide 24-hour nursing services furnished or supervised by a registered nurse.
• Ensure drugs and pharmaceuticals are prepared and administered in accordance with Federal and State laws and according to the orders of the practitioner(s) responsible for the patient’s care.
To the extent not waived, the Licensed Independent Freestanding ED named above is compliant with the requirements of 42 CFR 482.25 Condition of Participation: 
Pharmaceutical Services. In particular, but not limited to:
 
• Provide pharmaceutical services that meet the needs of the patients.
• Have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision.
• Provide a full-time, part-time, or consultant pharmacist who is responsible for all activities of the pharmacy services.
• Provide an adequate number of personnel to ensure high-quality pharmaceutical services, including emergency services.
• Ensure Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse and Prevention and Control Act of 1970 are kept locked within a secure area.
To the extent not waived, the Licensed Independent Freestanding ED named above is compliant with the requirements of 42 CFR 482.42 Condition of Participation:
Infection  Control and Antibiotic Stewardship Programs. In particular, but not limited to:
• Appointed a qualified individual as the Infection Preventionist/Infection Control Professional.
• Employ methods for preventing and controlling the transmission within the hospital and between other providers.
• Create an Infection Control Surveillance plan to control Healthcare Acquired Infections.
• Establish a hospital-wide antibiotic stewardship program in accordance with national standards.
To the extent not waived, the Licensed Independent Freestanding ED named above is compliant with the requirements of 42 CFR 482.57 Condition of Participation:
Respiratory  Services. In particular, but not limited to:
• Ensures that a director of respiratory care services who is a doctor of medicine or osteopathy is available on a full or part-time basis to supervise and administer respiratory services.
• Ensure an adequate number of qualified respiratory therapists and technicians.
• Ensure all respiratory services are delivered in accordance with medical staff directives.
To view CMS’s guidance for Independent Freestanding Emergency Departments, visit:

https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/guidance-licensed-independent-freestanding-emergency-departments-eds-participate-medicare-and.

For information specific to what CMS is doing in response to COVID-19, please visit the Current Emergencies Website.

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