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How to interpret conditions of participation, and options for program design to meet waiver requirements.

The following is a guide to interpreting CMS waiver requirements under the public health emergency, and program design options used by Hospital at Home programs to meet CMS conditions of participation.

Hospitals applying for the CMS waiver must attest to having the following structures and processes in place to provide acute care to patients in their homes:

  • Pharmacy
  • Infusion
  • Respiratory care including oxygen delivery
  • Diagnostics (labs, radiology)
  • Monitoring with at least 2 sets of patient vitals daily
  • Transportation
  • Food services including meal availability as needed by the patient
  • Durable Medical Equipment
  • Physical, Occupational, and Speech Therapy
  • Social work and care coordination

Interpreting and Meeting Conditions of Participation (COPs)

A key planning concept in Hospital at Home care is choosing antibiotic infusions and other IV medications that require dosing once or twice a day, to minimize staffing requirements. Treatment protocols for common diagnoses assist in creating care pathways that are effective and efficient.

Options on meeting pharmacy needs:

  • Hospital pharmacies may be able to dispense the oral and IV medications needed:
    • Are there any issues with your pharmacy licensing and the state pharmacy board about dispensing medications for use in the home?
    • How will your program obtain supplies and pumps for infusions?
  • Contract with an internal or external infusion company:
    • Some health systems already operate their own home infusion pharmacy
    • Or you may want to contract with a company offering home infusion pharmacy services
    • How will you ensure rapid delivery times and 7 day a week service?
  • Contract with a pharmacy in the community for oral medications:
    • How will the medications be delivered to the patient?
      • In some HaH programs, nurses have pick the medications up on the way to the house, others arrange for the pharmacy to deliver them
    • Some groups have medication boxes carried by providers or rapidly accessible to them to ensure rapid first-dose delivery. Click here for a sample medication box inventory form.
      • Providers or pharmacists will need to ‘dispense’ these medications to their patients. Ensure that this process is informed by federal and local pharmacy regulations.
    • Questions have been asked about infusing chemotherapy in the home. That would be a somewhat rare and special application of Hospital at Home that would need additional planning and attention. Is there an infusion pharmacy that can provide those specific medications (and the specially trained RN’s necessary to manage the infusions).
    • Safe transport of controlled substances is another question raised. Most programs use the ability for patients to continue to take their own medications as the method for delivering controlled substances.

Patient-administered medications are a special issue that has affected pre-existing HaH programs in addressing the waiver.

  • The Medicare COPs indicate that HaH programs must follow hospital policy on administering medications to patients. Several HaH programs have worked with their hospital administrators to addend existing policies to allow for patients to administer their own medications in their home during a HaH admission (updating their hospital policies to account for HaH requirements)

Several approaches to HaH pharmacy care were covered in the HaH Users Group webinar on 3/30/21. Click here to view that webinar and access presentation slides.

In addition, pharmacy services were covered in this webinar on HaH Ancillary Services

Your hospital will have processes and protocols in place from both the nursing and the pharmacy perspective. Please refer to these policies and update them as needed to include the needs of administering medications in the home. Click here for a list of policies that are common to hospitalizations that may need to be reviewed with Hospital at Home in mind.

Please include response times and details regarding the availability of oxygen delivery and treatment, nebulizer treatment, and any other respiratory services.

Oxygen options:

  • Contract with a DME company to supply oxygen and nebulizers, with a specified time to delivery
    • Companies can deliver cylinders to an ED for the patient to use while traveling home
    • Be aware that acute and short term oxygen use may not be a covered home benefit and be prepared to fund short term use through Hospital at Home
  • Per CMS’s waiver FAQ, a respiratory therapist is not required for respiratory care

Note CMS’s National Coverage Determination (NCD) for oxygen use in the home.

Include which laboratory studies, radiology tests, or other diagnostics are available and the expected time between the order placement and results. For services unavailable in home, how will these be provided via the hospital?

Common diagnostic services in the home can include:

  • Labs
  • X-rays
  • Ultrasounds
  • EKGs
  • Dopplers
  • Echocardiograms
  • One HaH group has a contracted provider that places PICC lines and midlines in the home

Consider: How will you arrange to have studies and reports:

  • Viewed by your providers?
  • Read by specialists?
  • Entered into the medical record? (It can be especially valuable to have lab results pulled into the record, for continuity and to “match” with ordered labs to verify that the orders were completed).
  • Printed labels for labs may be difficult to use – what forms will substitute for your clinicians delivering samples for analysis to your lab provider.

For diagnostic studies that need to be performed in a hospital department, how will you schedule the studies and transport the patient to the facility?

Determine an appropriate response time for your needs and include that in your contract with any ancillary service providers. Be sure you are aware of whether COVID is impacting the willingness of your contracted providers to deliver services in the home.

Click here to view a presentation recording and slides from a HaH Users Group webinar that discusses diagnostic studies and other ancillary services in the home.

These include, at a minimum, Heart Rate, Blood Pressure, Respiratory Rate, Oxygen Saturation, and Temperature.

Options:

  • Incorporate taking and documenting vitals into the current requirement of two in-person assessments daily by clinical staff
  • Use remote monitoring/telemedicine equipment to update vitals remotely, with or without a video visit component

Note that the language says “obtain and deliver” vitals, which supports using remote telemedicine methods to obtain vitals.

Include whether transport is provided by ambulance, non-ambulance medical transport, or other means.

Options:

  • Programs may use a variety of contracted transport providers to assist patients in moving from the ED or hospital to their home. Depending on patient acuity or mobility, this can include:
    • Private vehicles
    • Taxi or other ride-booking services, several of which have developed models of medical transport
    • Transport vans which can accommodate stretchers
    • Ambulance services

The balance between patient acuity and the cost of transport will need to be considered when planning services:

  • Does your admission criteria require that a patient be somewhat ambulatory? If so, do they need an ambulance or would a private vehicle or taxi suffice?
  • Does your patient require respiratory support, such as oxygen?
    • If so, will the starter tank be delivered to the hospital?
    • If an ambulance is required to give oxygen or CPAP services to a patient, do you have the contracted DME services and staff support to meet that ambulance at the home?
  • Are you admitting post-surgical patients? Do they have any special transport needs?
  • Does your institution already have contracts with service providers at negotiated rates that could be used for your HaH operations?

Note that the waiver states: Food services including meal availability as needed by the patient. It is important to include an assessment of the patient’s needs in initial evaluations, but meals are not required to be delivered to every patient that is admitted to the HaH program. Many programs have found that providing meals is a relatively rare requirement over the years. Assessing your patient’s food security is key to understanding their needs. Some patients may require assistance with simple food preparation in the home, rather than meal delivery; something that aides (or any of your clinicians) can assist with.

Options include:

  • Contract with an existing service, such as Meals on Wheels, which offers specific diets for many medical conditions.
    • Does your institution already have a contract with a similar program, perhaps through the care management team?
  • Contract with your hospital dietary department to provide meals for patients.
    • How will you arrange to have those meals delivered?
  • Assure delivery of basic needed grocery items to the home, including easy to prepare pre-packaged meals.
  • Arrange for delivery of prepared meals from surrounding restaurants, using a delivery pickup service.

Options include:

  • DME contracts no doubt already exist in your organization or health system, however, they may not specify the rapid turn-around time that a HaH program requires. Will you need to addend that contract to meet the program needs?
  • Hospice agencies often have DME contracts that specify a rapid delivery time. If you are in an institution with a partner hospice, they may be able to suggest DME companies that are responsive.

The admission of patients to an acute episode of inpatient home hospitalization precludes a simultaneous admission to a home health agency for home therapy services.

Considerations about the likely volume of therapy services:

  • The need for some types of therapy during the admission may be lower in HaH patients, who are often relatively mobile, less likely to become deconditioned, and may have a relatively short stay compared to more acute inpatients. Therapy services may be of more benefit directly following a HaH admission. Some groups transition identified patients directly to home health on discharge to assure the start or continuation of therapy services.
  • The acuity and type of patient being admitted (your eligibility and exclusion criteria) may help in evaluating the therapy staffing needs. Click here for a HaH Users Group webinar on eligibility and exclusion criteria.

Options for providing services include:

  • Contracting with a home health agency to provide services using their therapy staff, without a home health admission.
    • If so, how will you ensure that therapy is correctly documented in your charts? Home health staff tend to have documentation methods and technology which is quite different than inpatient documentation.
  • Contract with the therapy staff at your home hospital/outpatient system to provide services
    • Do these therapists have the training necessary to provide care in the home?
    • How will they document in your medical record?
  • Contract with private therapy groups in your community to provide services
    • Do these therapists have the training necessary to provide care in the home?
    • How will they document in your medical record?

Consider:

  • What revisions will your inpatient documentation need to reflect care in the home?
  • How will you ensure that basic needs for home services, including an evaluation of the safety of the home environment, are included in the therapist’s work?
  • Note: If you are working with a payer to deliver Hospital at Home under a bundled payment for services over for a discrete period of time (such as a “30-day bundle”), you may need a different approach to providing therapy services to those patients.

Please describe, in detail, your Acute Hospital Care at Home discharge process and processes to ensure seamless patient discharges.

Does your HaH team include staff with case management and care coordination experience, or with social work experience and licensing? What are the requirements in your hospital to provide these services? In all of the options below, remember that documenting (or importing records into) the HaH medical record is a critical need.

Options:

  • Hire staff with the needed experience and include documentation that will allow them to demonstrate this component of their work. Note that some staff may need to document clinically when offering some services, while documenting as a case manager at other points.
  • Many hospital systems now have ‘transition of care’ case managers who track patients to the home to assist with needed services and support. Can you work with that team?
  • Contract or partner with the existing inpatient hospital teams that offer these services
    • Are they experienced or comfortable doing home visits?
    • Can you use virtual visits to deliver these services? This offers efficiencies and assists clinicians who are less comfortable traveling to patient homes.
      • What technology or training will be needed for that model?
  • Contract or partner with the case management teams providing Medicare Advantage or Managed Medicaid services in your community to provide this service.
  • Contract or partner with local private agencies providing these services. There are often groups that specialize in case management of older patients in communities.
    • Do they demonstrate the necessary expertise and licensure to assure quality?

After this first in-person visit, an MD or Advanced Practice Provider must visit and examine each patient at least daily — this can be done remotely if appropriate based on the provider’s evaluation of the patient’s condition and course.

  • Explain your staffing model to ensure that this minimum level of oversight and care can be provided to each patient.

For a comprehensive staffing model example from Mount Sinai’s Hospital at Home service in New York City, click here. For guidance on staff scheduling and per-day visit expectations, click here.

Many programs initially contract for needed services prior to hiring staff. A business plan that determines the required HaH daily census to support full or part-time staff is key to a viable staffing model. If the decision is made to staff the HaH program with contracted clinicians, assure that the contracting agency understands the acuity of the patients in the HaH program.

Consider the differences between HaH care processes and the usual workflow of the contracting agency, and clearly articulate where requirements vary for HaH. For example: Home health agencies operate under regulations that require an initial visit within 48 hours of patient discharge from the hospital. It requires changes in their scheduling processes and operations to allow them to have a nurse in the home within two hours of an admission call or to meet patients in the ED.

There must be at least one in-person or remote visit with a Registered Nurse (RN) who develops a nursing plan consistent with hospital policies. If the RN determines it is clinically appropriate, the in-person visits can be with a Mobile Integrated Health (MIH) paramedic without RN on-site care.

  • Explain your staffing model, including whether you are able to ensure each patient is seen in-person or remotely by an RN at least daily. If your CCN plans to use MIH members on your team, explain their role in the team structure.

The CMS FAQ includes the following explanations of this requirement:

  • There must be at least two in-person visits daily. The RN on the required daily RN visit, (remote or in-person) may determine that both required in-person visits may be completed by a Mobile Integrated Health paramedic, if deemed consistent with the optimal plan for the patient’s care. If the team RN determines that an RN should see the patient in-person, one of the two daily in-person visits must be performed by an RN. (This implies that the RN creating the Care Plan daily could be developing that plan via in-person or video visit. That plan determines who will be doing the in-person visits, based on patient need and the RN assessment).
  • The paramedic needs to be recognized by an official body as being part of a Mobile Integrated Health/Community Paramedicine (MIH/CP) practice. Some states use specific licenses for MIH programs to recognize the additional training required for MIH. Additionally, MIH paramedics must receive constant medical direction if not abiding by a protocol. The paramedic used in the MIH role needs to be employed or under contract with the hospital to provide the MIH service. The hospital is responsible for the services and care provided by this team member.
  • The two in-person visits can be completed by an APP, but they do not substitute for the role of an RN in the patient’s care and must cover the expected care delivered by an RN, including the establishment of an appropriate nursing plan for the patient.
  • Immediate, on-demand remote audio connection with an Acute Hospital Care at Home team member who can immediately connect either an RN or MD to the patient
  • In-home appropriate emergency personnel team to the patient’s home within 30 minutes. This can be provided by 911 or emergency paramedics.

Options:

  • Telephone calls to an on-call clinician will meet the first requirement.
    • Is your team prepared to be on call to that extent?
    • Is there a partner on-call program (such as a hospital nurse triage line) that can assist with these calls? (If so, how will you share protocols with them and assure documentation in your EHR?)
    • What methods (and quality audits) will you use to assure that your on-call number is always answered?
    • How will you track call volumes and needs to develop additional operational support as needed?
  • Are you staffed sufficiently to have any other response to the second requirement other than using the existing 911 emergency response system?
    • For patients who prefer not to accept full spectrum medical treatment in an emergency situation: are patient wishes and goals documented in a POSLT-type or Advance Directive document and displayed or shared so that EMS will be aware of them?

Describe technology and device use (e.g. telephone, personnel emergency response system, remote telemetry), staffing, and any limitations based on time of day or weekend.

See the previous section for more details. For more information about the use of technology in HaH, click here.

Detail the algorithm and timing of each step in the process and describe which personnel will travel to the home. Describe any partnerships with local paramedic groups or other professionals who will improve this response time. Detail equipment that will travel with this team.

If EMS is the chosen response, the local EMS Bureau or Ambulance service should have protocols and equipment lists already prepared as part of their licensing process.

Do you use or have you adapted published selection criteria or do you use criteria developed on your own? Please give complete details including all inclusion and exclusion criteria.

Comprehensive guidance on how to develop HaH eligibility criteria – including inclusion and exclusion criteria – can be found in the Resources section of the HaH Users Group.

The hospital system housing the Hospital at Home program will have a Utilization Review/Management team to review all current admissions.

Meet with this team to clarify:

  • The current process for inpatient admission review
  • How the HaH admissions will be added to this process OR
  • If necessary, how the HaH admin team will train a reviewer
  • Milliman/Interqual criteria currently used to review all patients admitted with likely HaH diagnoses

CMS will contact this executive directly with any concerns about reporting or quality.

  1. Unanticipated mortality during the acute episode of care
  2. Escalation rate (transfer back to the traditional hospital setting during the acute episode)
  3. Volume of patients treated in this program

Please identify the single executive responsible for tracking these metrics:

The Hospital at Home Users Group presented a webinar on HaH quality measurement and safety evaluation on February 23, 2021. To view the presentation recording and download slides, click here.

In addition to HaH representatives, possible team members could include safety or quality officers in the hospital system, clinical leaders from departments most often served by the HaH program, representatives from pharmacy, nursing, compliance.

The Hospital at Home Users Group presented a webinar on HaH quality measurement and safety evaluation on February 23, 2021. To view the presentation recording and download slides, click here. For all Users Group resources related to quality, click here.

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