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Based on interviews, policy/document and record review, the facility failed to ensure there was a process in place to consistently obtain the signature of Medicare Beneficiaries/representatives acknowledging receipt and understanding of the Medicare Outpatient Observation Notice (MOON). Two of four notices (MOON) did not include a patient/representative signature. It is the hospitals responsibility to establish and implement policy procedures to ensure patients/representatives have the information needed to exercise their rights.

Findings include:

1) CMS (Center for Medicare and Medicaid Services) Manual Medicare Claims Processing Chapter 30-Financial Liability Protections last revised 12/20/2023 provides guidance for proper issuance of the MOON. The MOON was developed to inform all Medicare beneficiaries, when they are an outpatient receiving observation services, and are not an inpatient of the hospital or CAH (Community Access Hospital). The MOON is mandated by the Federal Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act).

The Act requires the facility to provide written and oral explanation of such written notification to individuals who receive observation services as outpatients for more than 24 hours. 400.3.3 states Hospitals must deliver the MOON to beneficiaries and "provide both standardized written MOON, as well as oral notification. ...The Hospital or CAH must ensure that the beneficiary or representative signs and dates the MOON to demonstrate that the beneficiary or representative received the notice and understands it contents. Use of assistive devices may be used to obtain a signature. Electronic issuance of the MOON is permitted. If a hospital ...elects to issue a MOON viewed on an electronic screen before signing, the beneficiary must be given the option of requesting paper issuance over electronic issuance if that is what the beneficiary prefers. Regardless of whether a paper or electronic version is issued and regardless of whether the signature is digitally captured or manually penned, the beneficiary must be given a copy of the MOON, as specified in 400.39, and the required beneficiary specific information inserted, at the time of notice delivery." The MOON may be delivered to a beneficiary's appointed representative to act on their behalf, or to an authorized representative (POA, legal guardian). The MOON must include the name of the representative with phone number contacted.

"There is an exception to the in-person notice delivery requirement. If the MOON must be delivered to a representative who is not physically present to receive delivery of the notice, the hospital is not required to make an off-site delivery to the representative. The hospital must complete the MOON as required and telephone the representative. The information provided telephonically includes all the contents of the MOON. "Mail a copy of the annotated MOON to the representative the day telephone contact is made. A hard copy of the MOON must be sent to the representative by certified mail, or any other delivery method that can provide signed verification of the delivery (e.g. FedEx, UPS). The burden is on the hospital or CAH to demonstrate that timely contact was attempted with the representative and that the notice was delivered. If the hospital or CAH and the representative both agree, the hospital or CAH may send the notice by fax or e-mail ..."

400.3.9-Notice Retention of the MOON: The hospital must retain the original signed MOON in the beneficiary's medical record. ..."

For individuals on Medicare, the distinction between inpatient and observation status is crucial in terms of the out-of-pocket costs for that care, but also for the coverage of care in a skilled nursing facility after the hospital stay. It is the patients/representatives right to be provided the MOON, with explanation of why their hospital stay is classified as observation.

2) Reviewed the Utilization Management Regional Policy and Procedure (SC.RUM.026) titled "Patient Classification" date approved 12/26/2023. The policy included:
"4.8 Hospital Outpatient Services: Care provided to the patient with the presumption that the care will span less than two midnights. Outpatient services can be provided at any level of care and are not determined by physical location. ..."
"4.8.1 Observation (OBS) Services: Observation is a service received by a Hospital Outpatient. A patient in Observation receives ongoing short-term treatment, assessment and reassessment before a decision can be made as to whether the patient will require further treatment as a Hospital Inpatient or will be discharged from the Hospital. ..."
"4.8.8 Notice of Observation Treatment (NOTICE) ACT: Requires hospitals to provide ALL Medicare beneficiaries including Medicare Advantage patients, a written notice (MOON) along with an oral discussion about the form when they receive outpatient Observation services for more than 24 hours." "5.2.2.9 The CMS (Centers for Medicare & Medicaid Services) MOON Form will be given to the patient at 24 hours or before 36 hours with the following oral explanations given with the written form: ..." "5.2.2.9.1 The patient is a Hospital Outpatient and not a Hospital Inpatient of the hospital and the reason why." "5.2.2.9.2 The implications of remaining in Hospital Outpatient status (financial implications including deductibles, coinsurance, items not covered by Medicare such as self-administered drugs." "5.2.2.9.3 The time spent as a Hospital Outpatient, including Observation services provided on the inpatient floor, will not count towards the Medicare FFS (Fee for Service) 3-Day acute care qualifying stay required for SNF (skilled nursing facility) coverage. " "5.2.2.9.4 The notice must be written and spoken in an easy to understand language." "5.2.2.9.5 The notice must be signed by the patient or patient's representative." "5.2.2.9.6 The notice must be signed by hospital staff who presented the notice to the patient." "5.2.2.9.7 If the patient or patient's representative refuses to sign." "5.2.2.9.7.1 The hospital must indicate the refusal on the form." "5.2.2.9.7.2 Include the name, title, and signature of the staff issuing the notice as well as the date and time of the refusal." "5.2.2.9.7.3 Explain to the patient/representative that refusal to sign the form does not release the beneficiary from financial liability."

Reviewed the facility's electronic Medicare Outpatient Observation Notice (MOON), which was the standardized CMS form 10611. The form included a place for signature of Patient or Representative with date and time. There is a drop down menu for "Moon Signature List," that included the following choices. The choices included: 1) "I have reviewed and discussed the MOON (Medicare Outpatient Observation Notice) with the patient or representative and their signature was provided." 2) "I have reviewed and discussed the MOON ...with the patient or representative, they declined to provide their signature." 3) "I have telephonically reviewed and discussed the MOON ... with the patient's representative, *** at ***." 4) option to write in other information. The signature section also included "You have the right to get Medicare information in an accessible format. ...You also have the right to file a complaint if you feel you've been discriminated against. ..."

3) P1 had been determined to be incapacitated and his Family Member (FM)1 was designated Power of Attorney (POA)/representative. P1 was designated outpatient observation status and received observation services starting on 03/08/2024. Review of the MOON revealed it was electronically generated and signed by Patient Care Coordinator (PCC), on 03/29/2024 at 10:36 AM. The notice included "I have telephonically reviewed and discussed MOON (Medicare Observation Notice) with the patient's representative at 1038am on 3.29.2024 [sic]." There was no name of who the representative was, no representative signature with date and time to demonstrate the representative received the notice and understood the contents. Reviewed all PCC notes, which did not include any instructions to the representative to sign the MOON, or provide any indication why a signature could not be obtained. The facility was unable to provide a signed copy of the MOON or follow up to this notice.

P2 had been determined to be incapacitated and his Family Member (FM)2 was the representative. Review of the Moon revealed the entry: "I have telephonically reviewed and discussed the MOON (Medicare Outpatient Observation Notice) with the patient's representative, FM2 at 315pm on 4/9/2027 (incorrect date)," electronically signed by PCC at 3:20 PM. There was no signature of representative (FM2) with date or time. The PPC did document in progress notes the representative was out of town, but did not note this on the notice and did not instruct FM2 to sign the document when he returned. The facility was unable to provide a signed copy of the MOON, or follow up for signed receipt.

4) On 04/16/2024 at approximately 03:30 PM, during an interview with the Utilization Manager (UM), she described the process to deliver the MOON to patients/representatives. She said it was a shared responsibility of the finance staff and Patient Care Coordinators. Finance staff provide the notice when they are in the hospital, Monday through Friday day hours. Off hours and weekends, the PCCs assume the responsibility. The UM said the notice is a template available in the electronic system and after completed and electronically signed by facility staff, it is printed, reviewed with patient/representative and signed. She went on to say if the patient was incapacitated, and the representative was not present at that time, they would call the representative, explain the content over the phone, and when they come to the hospital, provide a copy and obtain their signature.

On 05/17/2024 at 09:15 AM. interviewed the Supervisor of Business Operations (SBO) and the Assistant Administrative Continuum (AAC) in the conference room. The SBO said the finance staff go to the patient's room and talk with the patient to explain the specifics of the notice. If the patient is incapacitated, they would talk to the patient's representative. If the representative is not in the hospital at the time, they would call the representative, explain specifics of the notice on the phone and "ask them to stop in the office to sign within next 24 hours." The SBO said they try their best to get them signed, and if unable, for any reason, they would document the circumstances.

On 05/17/2024 at 10:00 AM, during a telephone interview with PCC, she said when a patient comes in and is flagged as an admission, from the Emergency Department, she will review the medical record and use InterQual criteria (Evidence-based criteria/guidelines to determine inpatient or observation level of care) to determine which criteria (observation or inpatient) the patient meets. She went on to say there is always a discussion with the provider, who makes the final decision. The PCC said the policy is that they are to rescreen the patient every 24 hours for appropriate status. She said the MOON is generated from a template in the electronic system and it has a feature that also allows a copy to be sent by email. The PCC said the goal is to hand the patient/representative a hard copy and also send an email. She said "for the most part, it is signed by the patient, but sometimes the patient will ask them to review it with someone else, or the patient may be incapacitated and unable to understand or sign." In those situations, she contacts the representative by phone, reviews the material, documents who she spoke with and notes the date and time. The PCC said she then leaves a copy of the MOON in the patient's room. The PCC said it is not her practice when the MOON is delivered by phone to tell the representative it is importance to come in and sign the MOON in a timely manner. She said her focus has been on explaining the notice.