The Carelon Clinical Appropriateness Guidelines (hereinafter “the Carelon Clinical Appropriateness Guidelines” or the “Guidelines”) are designed to assist providers in making the most appropriate treatment decision for a specific clinical condition for an individual. The Guidelines establish objective and evidence-based criteria for medical necessity determinations, where possible, that can be used in support of the following:

To establish criteria for when services are medically necessary
To assist the practitioner as an educational tool
To encourage standardization of medical practice patterns
To curtail the performance of inappropriate and/or duplicate services
To address patient safety concerns
To enhance the quality of health care
To promote the most efficient and cost-effective use of services

The Carelon guideline development process complies with applicable accreditation and legal standards, including the requirement that the Guidelines be developed with involvement from appropriate providers with current clinical expertise relevant to the Guidelines under review and be based on the most up-to-date clinical principles and best practices. Resources reviewed include widely used treatment guidelines, randomized controlled trials or prospective cohort studies, and large systematic reviews or meta-analyses. Carelon reviews all of its Guidelines at least annually.

Carelon makes its Guidelines publicly available on its website. Copies of the Guidelines are also available upon oral or written request. Additional details, such as summaries of evidence, a list of the sources of evidence, and an explanation of the rationale that supports the adoption of the Guidelines, are included in each guideline document.

Although the Guidelines are publicly available, Carelon considers the Guidelines to be important, proprietary information of Carelon, which cannot be sold, assigned, leased, licensed, reproduced or distributed without the written consent of Carelon.

Carelon applies objective and evidence-based criteria, and takes individual circumstances and the local delivery system into account when determining the medical appropriateness of health care services. The Carelon Guidelines are just guidelines for the provision of specialty health services. These criteria are designed to guide both providers and reviewers to the most appropriate services based on a patient’s unique circumstances. In all cases, clinical judgment consistent with the standards of good medical practice should be used when applying the Guidelines. Guideline determinations are made based on the information provided at the time of the request. It is expected that medical necessity decisions may change as new information is provided or based on unique aspects of the patient’s condition. The treating clinician has final authority and responsibility for treatment decisions regarding the care of the patient and for justifying and demonstrating the existence of medical necessity for the requested service. The Guidelines are not a substitute for the experience and judgment of a physician or other health care professionals. Any clinician seeking to apply or consult the Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment.

The Guidelines do not address coverage, benefit or other plan specific issues. Applicable federal and state coverage mandates take precedence over these clinical guidelines, and in the case of reviews for Medicare Advantage Plans, the Guidelines are only applied where there are not fully established CMS criteria. If requested by a health plan, Carelon will review requests based on health plan medical policy/guidelines in lieu of the Carelon Guidelines. Pharmaceuticals, radiotracers, or medical devices used in any of the diagnostic or therapeutic interventions listed in the Guidelines must be FDA approved or conditionally approved for the intended use. However, use of an FDA approved or conditionally approved product does not constitute medical necessity or guarantee reimbursement by the respective health plan.

The Guidelines may also be used by the health plan or by Carelon for purposes of provider education, or to review the medical necessity of services by any provider who has been notified of the need for medical necessity review, due to billing practices or claims that are not consistent with other providers in terms of frequency or some other manner.

General Clinical Guideline

Clinical Appropriateness Framework

Critical to any finding of clinical appropriateness under the guidelines for a specific diagnostic or therapeutic intervention are the following elements:

Prior to any intervention, it is essential that the clinician confirm the diagnosis or establish its pretest likelihood based on a complete evaluation of the patient. This includes a history and physical examination and, where applicable, a review of relevant laboratory studies, diagnostic testing, and response to prior therapeutic intervention.
The anticipated benefit of the recommended intervention is likely to outweigh any potential harms, including from delay or decreased access to services that may result (net benefit).
Widely used treatment guidelines and/or current clinical literature and/or standards of medical practice should support that the recommended intervention offers the greatest net benefit among competing alternatives.
There exists a reasonable likelihood that the intervention will change management and/or lead to an improved outcome for the patient.

Providers may be required to submit clinical documentation in support of a request for services. Such documentation must a) accurately reflect the clinical situation at the time of the requested service, and b) sufficiently document the ordering provider’s clinical intent.

If these elements are not established with respect to a given request, the determination of appropriateness will most likely require a peer-to-peer conversation to understand the individual and unique facts that would justify a finding of clinical appropriateness. During the peer-to-peer conversation, factors such as patient acuity and setting of service may also be taken into account to the extent permitted by law.

Simultaneous Ordering of Multiple Diagnostic or Therapeutic Interventions

Requests for multiple diagnostic or therapeutic interventions at the same time will often require a peer-to-peer conversation to understand the individual circumstances that support the medical necessity of performing all interventions simultaneously. This is based on the fact that appropriateness of additional intervention is often dependent on the outcome of the initial intervention.

Additionally, either of the following may apply:

Current literature and/or standards of medical practice support that one of the requested diagnostic or therapeutic interventions is more appropriate in the clinical situation presented; or
One of the diagnostic or therapeutic interventions requested is more likely to improve patient outcomes based on current literature and/or standards of medical practice.

Repeat Diagnostic Intervention

In general, repeated testing of the same anatomic location for the same indication should be limited to evaluation following an intervention, or when there is a change in clinical status such that additional testing is required to determine next steps in management. At times, it may be necessary to repeat a test using different techniques or protocols to clarify a finding or result of the original study.

Repeated testing for the same indication using the same or similar technology may be subject to additional review or require peer-to-peer conversation in the following scenarios:

Repeated diagnostic testing at the same facility due to technical issues
Repeated diagnostic testing requested at a different facility due to provider preference or quality concerns
Repeated diagnostic testing of the same anatomic area based on persistent symptoms with no clinical change, treatment, or intervention since the previous study
Repeated diagnostic testing of the same anatomic area by different providers for the same member over a short period of time

Repeat Therapeutic Intervention

In general, repeated therapeutic intervention in the same anatomic area is considered appropriate when the prior intervention proved effective or beneficial and the expected duration of relief has lapsed. A repeat intervention requested prior to the expected duration of relief is not appropriate unless it can be confirmed that the prior intervention was never administered. Requests for on-going services may depend on completion of previously authorized services in situations where a patient’s response to authorized services is relevant to a determination of clinical appropriateness.

Post-Acute Care

General Information

Abbreviations

Americans with Disabilities Act (ADA)
Centers for Medicare & Medicaid Services (CMS)
Durable Medical Equipment (DME)
Health-Related Social Needs (HRSN)
Inpatient Rehabilitation Facility (IRF)
Level of Care (LOC)
Long-Term Acute Care Hospital (LTACH)
Occupational Therapy (OT)
Percutaneous Endoscopic Gastrostomy Tube (PEG)
Physical Medicine and Rehabilitation (PM&R)
Physical Therapy (PT)
Post-Acute Care (PAC)
Skilled Nursing Facility (SNF)
Speech Language Pathology (SLP)

Guideline Scope

This guideline addresses post-acute care (PAC) in an Inpatient Rehabilitation Facility (IRF). Specifically, the criteria below establish the appropriateness of initial admission to an IRF upon discharge from hospital, admission from home, or admission from another level of PAC. Additional criteria outlined below further establish the appropriateness of continuing facility-based PAC at an IRF.

The guideline applies to all patients of all ages and conditions discharged from the hospital. Due to the variety of clinical scenarios in scope, the guideline focuses on the principles needed to establish appropriateness of a given level of PAC.

Definitions

Active medical management – generally requires direct physician monitoring, involvement, or intervention for medical issues at least 3 days per week for inpatient rehabilitation facilities.

Functional impairment – A mobility, self-care, cognitive and/or behavioral-related impairment which has been determined via a comprehensive, skilled assessment of the patient’s clinically significant activities on at least one validated functional measure.

Most appropriate PAC Level of Care – the facility type that offers the necessary and appropriate type and intensity of care—including specialized clinical staff and equipment—and no more.

Examples:

- a SNF is a more appropriate level of PAC than an IRF or LTACH if the necessary type and intensity of care can be provided in the SNF environment
- an IRF is a more appropriate level of PAC than a LTACH if the necessary type and intensity of care can be provided in the IRF environment

Post-acute care settings

Skilled Nursing Facility (SNF) – An inpatient facility providing skilled nursing with or without rehabilitative care and classified by the Centers for Medicare & Medicaid Services (CMS) as a SNF or by a state accrediting agency to perform the same or similar functions as a SNF. Typically, it provides such care on a less than long-term basis and may be free-standing or contained within another medical institution such as a nursing home or acute care hospital. It is traditionally considered the lowest level of facility-based post-acute care, though this may vary depending on the individual facility’s characteristics.
Inpatient Rehabilitation Facility (IRF) – An inpatient facility providing high-intensity, multi-disciplinary rehabilitative care coordinated by a rehabilitation physician. IRFs are commonly freestanding but may be contained within an acute care hospital. IRFs are traditionally considered the highest level of rehabilitative post-acute care and intended for patients whose care needs are primarily rehabilitative. Also commonly referred to as “Acute Rehab” or “Acute Inpatient Rehab.”
Long-Term Acute Care Hospital (LTACH) – An inpatient facility providing medical and rehabilitative care for patients whose medical care needs exceed their rehabilitative care needs and who are expected to require an extended course of medical treatment relative to an acute care hospital (extended course typically expected to be 25 days). Also commonly referred to as Long-Term Acute Care (LTAC) or Long-Term Care Hospital (LTCH).

Qualified provider of skilled care – refers to someone who is duly licensed or certified by his/her state to deliver the specific services s/he is rendering and provides such services in accordance with his/her state’s respective practice act. State regulations regarding appropriate providers may supersede this guideline.

General PAC principles

A facility must be sufficiently accessible (e.g., ADA compliant) to avoid compromising a patient’s care or their potential to achieve the therapeutic goals
- Example: for patients whose goals include improved independence with toilet transfers from a wheelchair, a facility without wheelchair-accessible bathrooms would not be appropriate
When noted in the submitted clinical documentation, health-related social needs (HRSN) that will impact the patient’s discharge to the community may be screened and considered for appropriate, available resources

Clinical Indications

Initial Inpatient Rehabilitation Facility Care

Criteria for Initial Admission to IRF

Admission to IRF is considered medically necessary when:

ALL the following general and specialized interventions criteria are met:

Services cannot reasonably and/or safely be provided in a home or community setting due to insufficient availability, intensity, or type of services, and/or necessary equipment is unavailable
An IRF is more appropriate than a SNF or LTACH
- Most appropriate PAC Level of Care is the facility type that offers the necessary and appropriate type and intensity of care—including specialized clinical staff and equipment—and no more (see Definitions)
Services ordered are reasonable in scope, intensity, and duration for the condition being treated
Care will be provided by Qualified Providers (see Definitions) of the respective skilled services
Patient’s diagnostic work-up and care plan have largely been determined, and any ongoing medical care needs do not exceed the capabilities of the IRF
There is documented need for daily, multi-disciplinary skilled rehabilitation interventions (e.g., PT, OT, SLP, psychology, prosthetics/orthotics, rehab nursing, case management). At minimum, the treatment team will include a rehabilitation physician, a registered nurse with specialized training or experience in rehabilitation, therapists from at least 2 disciplines, and a social worker or a case manager.
Need for rehab program which is closely directed, supervised, and coordinated by a Physical Medicine and Rehabilitation (PM&R) physician (exceptions considered for facilities with no access to a PM&R specialized physician, for instance due to geographic limitations)
Reasonable expectation that patient will be able to participate effectively in and benefit from an intensive, multi-disciplinary rehab program, or otherwise have compelling rehab needs that cannot be adequately addressed at lower level of PAC (e.g., SNF)
- If patient is currently receiving skilled therapy in a SNF, ANY of the following pertaining to his/her participation must apply:
Patient is demonstrating consistently good participation and compliance
More specialized rehab care would be expected to result in improved participation and compliance
Patient recently experienced a change in functional status that allows increased participation and benefit from a more intense program
Reasonable expectation and potential for patient to achieve meaningful, quantifiable, and sustained functional improvement
Reasonable expectation of ONE of the following discharge dispositions:
- IRF stay will result in discharge to home and/or community
- IRF stay will result in discharge to long-term care with clinically significant improvement in functional independence and burden of care (including improvement in ability to direct their own care)

AND there is documented need for AT LEAST TWO of the following three categories of specialized interventions:

Active Medical Management* during the course of rehabilitation due to a reasonable expectation of ANY of the following:
Medical stability will be at risk with resumption/progression of activity
Patient will have specialized medical needs related to rehab condition
Such management will be necessary to maximize participation in therapies and optimize outcomes most efficiently
Such management will minimize and simplify medication regimens
Such management will facilitate discharge to community at higher level of independence (e.g., earlier decannulation or PEG removal, definitive long-term neurogenic bowel/bladder program,)

*Active Medical Management generally requires direct physician monitoring, involvement, or intervention for medical issues at least 3 days per week

Higher level of rehabilitative care with respect to ONE or more of the following:
- Programmatic specialization (e.g., accredited spinal cord injury, traumatic brain injury, pediatric and/or burn rehabilitation programs)
- Intensity

Note: Intensity typically refers to an anticipated need for 3 hours/day or 15 hours/week of skilled therapy

- Integrated care involving coordination between rehab disciplines (e.g., bowel/bladder management requiring coordination of rehab physician, nursing, and therapist care), or between rehab and non-rehab disciplines (e.g., wound management requiring coordination of care between plastic surgery team and rehab team)
Need for specialized equipment* to:
- Optimize functional outcomes
- Avoid or minimize complications of inappropriate equipment (resulting in additional/extended care needs)
- Optimize safety of patient and therapist during treatment (e.g., body weight supported gait training apparatus, tilt table)
- Minimize need for medications during treatment (e.g., enclosure beds and other non-pharmacological restraints for fall prevention in agitated patients)

*Note: Specialized equipment refers to equipment generally available only in the IRF and/or requiring the expertise of the IRF staff to employ appropriately

AND there is a documented need for EITHER of the following reasons for skilled services:

Functional impairment which reflects a clinically significant decline from (pre-hospitalization) baseline and precludes safe discharge to home
Complete assessment of caregiving needs and training of caregiver(s) to allow for safe return to community
- Such caregiver(s) must be identified prior to transfer from acute hospital
- There must be a reasonable expectation that caregiver(s) can be adequately trained to meet the patient’s care needs fully upon discharge to community

Ongoing Inpatient Rehabilitation Facility Care

Criteria for Continuation of IRF-Based Care

Continuation of IRF care may be medically necessary when the following criteria are met:

ALL the following general criteria:

All criteria for admission to IRF continue to be met (see Criteria for Initial Admission to IRF)
Therapeutic goals have been established and documented
There is at least one remaining functional, therapeutic goal which:
- Is likely attainable in a reasonable and predictable timeframe
- Is re-assessed at least weekly
- Will meaningfully improve patient’s functional independence and/or safety
Patient has demonstrated good tolerance of and consistent, meaningful participation in all therapies
A discharge plan has been formulated and, to the extent possible, executed contemporaneously during stay (so as not to extend stay unnecessarily)
Progress towards goals has been commensurate with the duration of treatment

and ANY of the following pertaining to patient’s progress:

Patient has had a clinically significant, quantifiable, and favorable response to interventions within a reasonable timeframe, evidenced by a trend of functional and/or medical improvement (e.g., when medical management was needed in order for functional improvement to occur/resume)
Patient has a lack of clinically significant or favorable response but has an acceptable and temporary mitigating factor(s) accounting for a limited response, such as intervening illness or injury
Patient has a lack of clinically significant or favorable response, but the plan of care has been modified in a way that is likely to improve the response in a reasonable timeframe
Patient’s progress has plateaued, but s/he has had a change in status that:
- enables upgraded goals*
- improves potential (e.g., non-weight bearing to weight bearing as tolerated, upgraded dysphagia diet, improved medical condition); and/or
- would facilitate earlier discharge to community (e.g., decannulation, upgrade to po diet from PEG)

*Note: goals must still require IRF-based care to achieve

Patient’s progress has plateaued, but current home environment cannot safely accommodate his/her functional and/or medical needs and will be able to within a reasonable time of patient achieving the established therapeutic goals if:
- appropriate structural modifications can be made (e.g., widened bedroom door necessary for patient’s wheelchair), (such modifications should have been pursued as soon as need became apparent); and/or
- necessary caregiver services arranged (such arrangements should have begun as soon as need became apparent)

Exclusions

IRF facility care will be considered Not Medically Necessary when:

There is no reasonable expectation of progression (or further progression) towards goals.

Example for Initial Admission:

- There is a cognitive condition such as dementia that is likely to preclude effective learning and carry-over when goals depend on such abilities

Examples for Ongoing Care:

- Patient is at their pre-hospitalization functional baseline
- Identified caregiver is unwilling or unable to provide the necessary care for patients whose goals depend on caregiver involvement.
- A caregiver is unavailable or unable to participate in the education and training with the patient as needed to achieve therapeutic goals
Discharge is delayed due to pending home modifications that are not required in order to accommodate patient safely upon discharge or that cannot be completed within a reasonable time relative to meeting therapeutic goals

Examples:

- Widening the front door when there is another viable door for patient’s entry/exit
- Taking extra time to install a permanent concrete ramp when a temporary, safe ramp can be installed quicker
- A contractor is not available to work on a home modification for at least another week
Services otherwise do not meet clinical criteria outlined above

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History

Status	Review Date	Effective Date	Action
Updated	01/23/2024	09/01/2024	Independent Multispecialty Physician Panel (IMPP) review of General Clinical Guideline. Added required language per new Medicare regulations.
Updated	n/a	Unchanged	Disclaimers updated from Post Acute Solutions to Carelon Medical Benefits Management.
Revised	10/23/2023	TBD 2024	Independent Multispecialty Physician Panel (IMPP) review. Restructured original PAC guidelines into 3 separate, level of care specific guidelines; updated Background and Definitions and refined several criteria to be more applicable to IRF; removed facility accessibility and HRSN criteria; removed requirement for physician referral; added criteria in Ongoing IRF Care regarding remaining therapeutic goals; added verbiage and examples to clarify original intent or for more level of care-specific applicability; removed most criteria pertaining to transfer between IRF and other levels of PAC. Added required language per new Medicare regulations.
Created	04/12/2023, 02/03/2022	09/01/2023	Independent Multispecialty Physician Panel (IMPP review). Restructured by level of care and clarified admission criteria. Original effective date.

Coming soon

Post Acute Care Inpatient Rehabilitation Facility 2024-09-01

Clinical Appropriateness Guidelines

Table of Contents

Description and Application of the Guidelines