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ModifiedSelectHealthPolicy 616

Coverage with Evidence Development

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Defines SelectHealth's approach to covering items/services conditionally when evidence is being developed, aligning with CMS CED paradigms and applying to Commercial, Medicare, and Medicaid/CHIP plans as specified.

Policy Summary

PayerSelectHealth

PolicyCoverage with Evidence Development

Policy CodePolicy 616

Change TypeRevised criterion (material)

Effective DateSep 1, 2023

Last ReviewFeb 14, 2025

Next Review DateFeb 14, 2025

Key ActionEnsure patients meet NCD-specified criteria and participate in required data collection/registries when CED (CAD or CSP) applies.

SourceLink

POLICY UPDATE CHANGES

For Commercial Plan Policy, modified criterion #3 as follows: "The member meets InterQual guidelines for SNF"

27NCDs requiring CED

>120CED studies approved

5National registries approved

Not coveredCategory A IDE

Conditionally coveredCategory B IDE

CoveredRoutine trial costs

Coverage Criteria — CED, CAD, CSP, IDE, PDN

General Guidelines Requirements for Coverage with Evidence

Covered when ALL of the following are met:

CED General Guidelines: 1) Principal purpose of the study is to test whether the item or service meaningfully improves health outcomes for affected beneficiaries represented by the enrolled subjects; 2) Rationale for the study is well supported by available scientific and medical evidence; 3) Study results are not anticipated to unjustifiably duplicate existing knowledge; 4) Study design is methodologically appropriate and anticipated enrollment is sufficient to answer the NCD research question(s); 5) Study is sponsored by an organization or individual capable of successful completion; 6) Research complies with applicable federal human subjects protection regulations (45 CFR Part 46 and, if FDA-regulated, 21 CFR Parts 50 & 56) and meaningful informed consent is obtained; 7) All aspects of the study are conducted according to appropriate standards of scientific integrity; 8) Study has a written protocol demonstrating adherence to Medicare requirements; 9) Study is not designed exclusively to test toxicity or pathophysiology in healthy individuals except in life‑threatening circumstances with no viable options; 10) Clinical research studies and registries are registered on ClinicalTrials.gov (and registries on AHRQ RoPR) prior to first enrollment; 11) Protocol specifies method and timing of public release of all prespecified outcomes and results are made public within 12 months of primary completion; 12) Protocol includes plan for inclusion/retention/reporting of underrepresented populations and discusses how inclusion/exclusion criteria affect enrollment; 13) Protocol discusses generalizability of results to beneficiary subpopulations (e.g., Medicare by age, disability, Medicaid eligibility)all

Policy Summary

PayerSelectHealth

PolicyCoverage with Evidence Development

Policy CodePolicy 616

Change TypeRevised criterion (material)

Effective DateSep 1, 2023

Last ReviewFeb 14, 2025

Next Review DateFeb 14, 2025

Key ActionEnsure patients meet NCD-specified criteria and participate in required data collection/registries when CED (CAD or CSP) applies.

SourceLink

On This Page

Coverage with Appropriateness Determination (CAD)

CAD invoked when CMS finds evidence adequate for coverage but requires extra data to ensure appropriate use; coverage only for patients included in required data collection.

CAD Conditions: CMS may require Coverage with Appropriateness Determination (CAD) when there is adequate evidence that an item/service is reasonable and necessary but additional clinical data (not routinely available in claims) are needed to ensure appropriate use. CAD is used to: 1) restrict use to patients meeting specific conditions/criteria; 2) restrict use to providers with specific training or credentials; 3) address concerns about substantial opportunities for misuse; 4) monitor significant changes in patient management arising from the coverage decision. Data must be submitted to registries/databases that conform to accepted standards (qualified scientific oversight, validated data collection methods, patient safety/monitoring, quality assurance, data protection, and appropriate human subjects protections). Only items/services for patients included in the required data collection are covered under CAD.all

Coverage with Study Participation (CSP)

CSP applies when evidence is inadequate for coverage but coverage may be provided within qualified clinical research studies that meet standards.

CSP Conditions: Coverage with Study Participation (CSP) applies when available evidence is inadequate to determine that an item or service is reasonable and necessary under section 1862(a)(1)(A), but coverage may be provided for Medicare beneficiaries enrolled in qualifying research studies that provide added safety, patient protections, monitoring, and clinical expertise. CSP requires that studies: have assurance of basic safety when applicable; potentially offer high benefit to beneficiaries where appropriate; address significant barriers to conducting trials when relevant; be designed to produce evidence that could be used in future national coverage decisions; and conform to standards set by Clinical Research Policy (trial design may include rigorous observational research as appropriate). Reimbursement under CSP is limited to Medicare qualified patients enrolled in eligible studies and routine costs of the study may be reimbursed when trial standards are met.all

Coverage with Evidence Development — Trial Approval Criteria

Covered when ALL of the following are met for a clinical trial:

CED Trial Requirements: 1. Primary purpose of the trial is to test whether the intervention potentially improves participants' health outcomes; 2. Trial is well‑supported by available scientific/medical information or intended to clarify outcomes of interventions already in common use; 3. Trial does not unjustifiably duplicate existing studies; 4. Trial design is appropriate to answer the research question; 5. Trial is sponsored by a credible organization or individual capable of executing it successfully; 6. Trial follows federal regulations for protection of human subjects; 7. Trial conduct meets appropriate standards of scientific integrity; 8. Trial is listed in the National Library of Medicine clinical trials database (ClinicalTrials.gov); 9. Study sample includes individuals representative of the Medicare population with the condition described in the NCD.

From policy CED requirements

IDE (Category B) Coverage Criteria

SelectHealth covers Category B IDE devices when ALL of the following are met:

Category B IDE Coverage Criteria: 1) Device has attained Category B FDA status; 2) Device is being used as part of an investigational study supporting an FDA PMA application (or equivalent investigational use); 3) Investigational study has Institutional Review Board (IRB) approval; 4) Device is used by a participating SelectHealth provider; 5) If hospital use is required, the device is administered at a contracted facility; 6) SelectHealth has reviewed available safety data and determines adequate support exists for safety/efficacy to allow conditional coverage.

From IDE coverage section

Routine Patient Costs Coverage Criteria

Covered when ALL of the following are met

Qualified Individual and Approved Trial: Individual is covered under the health plan and is eligible to participate in an approved clinical trial per the trial protocol; the trial must meet definitions for approved clinical trials (federally funded, FDA IND, or peer‑reviewed qualifying entities) as described in policy.

Trial documentation and IRB approval: The clinical trial must have a written protocol describing a scientifically sound study and IRB approval prior to enrollment; Select Health may request documentation and requires the trial evaluate a Covered Health Service not otherwise excluded.

Use of network providers: If network providers participate in the trial, the Qualified Individual must use a network provider when available and the network provider will accept the participant; Select Health may deny or limit payment for out‑of‑state or out‑of‑network trials per plan design.

Private Duty Nursing - Coverage Criteria

Covered when ALL of the following are met:

PDN coverage conditions: 1) Patient is under active case management with Select Health; 2) Member meets InterQual guidelines for SNF when applicable; 3) Member is ventilator‑ or tracheostomy‑dependent OR has skilled nursing needs requiring PDN; 4) Primary care physician or specialist agrees to the home care plan; 5) Placement of the nurse is for a skilled need and for the benefit of the member; 6) Member and family acknowledge the service is temporary as a transition to an alternative care environment; goal is transition off PDN within approximately 3 months. Maximum hours may be used PRN for acute exacerbations and short temporary increases (examples up to 2 weeks) may be considered.service usually not to exceed 3 months; temporary PRN increases allowed

Specific hour allocations for ventilator/tracheostomy dependency are listed in policy text.

General Coverage Conditions

Covered when the service is medically necessary and provided as skilled, temporary home nursing under medical supervision

PDN coverage conditions: Service is medically necessary, provides complex skilled nursing care in the home by an RN or LPN, is intended to assist transition from acute care to home and to teach caregivers, and is temporary rather than permanent ongoing care.

Items and services that are experimental or investigational and are not determined to be reasonable and necessary under section 1862(a)(1)(A) are considered non‑covered except where coverage is explicitly allowed under a qualifying Coverage with Evidence Development (CED) arrangement (for example, when provided as necessary placebo or control interventions in an approved CED study under section 1862(a)(1)(E)).

SelectHealth does NOT cover Category A investigational devices (experimental). Category A devices are those for which initial questions of safety and effectiveness remain unresolved and the absolute risk of the device type has not been established.

Items or devices that are themselves investigational and any services provided solely to satisfy study data collection or analysis and not used in direct clinical management are not covered. Examples include protocol‑driven laboratory or imaging studies performed at frequencies beyond standard care and other procedures used only for data collection purposes.

Services that are specifically excluded by the member's benefit contract are not covered. Providers must verify coverage against the member's plan and consider contractual exclusions when determining benefit eligibility for clinical trial or investigational services.

Private duty nursing (PDN) is intended to provide temporary, skilled, complex nursing care in the home for assessment, monitoring, caregiver training, and transition from acute care. Services intended to function as permanent, ongoing home nursing are outside the purpose of PDN and are excluded from coverage under this policy.

When the available evidence is inadequate to determine that an item or service is reasonable and necessary under section 1862(a)(1)(A), that item or service is not covered for Medicare beneficiaries unless coverage is provided only in the context of qualifying research studies (Coverage with Study Participation) that meet required standards and protections.

Services that are clearly inconsistent with widely accepted and established standards of care for a particular diagnosis are not eligible for coverage as routine patient costs in a clinical trial and are therefore not covered under this policy.

Services that do not meet the Utah State definition of medical necessity—that is, not clinically appropriate in type, frequency, extent, site, or duration; primarily for convenience; not covered under the contract; or not supported by appropriate evidence—are excluded from coverage.

Provision of PDN as permanent, ongoing care rather than temporary, skilled nursing for transition or stabilization is considered inconsistent with the stated purpose of PDN and may be denied as not medically necessary or excluded from coverage.

Billing, Codes, Modifiers

CPT/HCPCS/CPL codesmixed

No codes listed

These Codes may be covered if criteria are metHCPCSCovered

S9988	Services provided as part of a Phase Clinical Trial
S9990	Services provided as part of a Phase II Clinical Trial
S9991	Services provided as part of a Phase III Clinical Trial
G0293	Noncovered surgical procedure(s) using conscious sedation, regional, general or spinal anesthesia in Medicare qualifying Clinical Trial, per day
G0294	Noncovered procedure(s) using either no anesthesia or local anesthesia only, in a Medicare qualifying clinical trial, per day

These codes are not coveredHCPCSNot Covered

G9057	Oncology; practice guidelines; management differs from guidelines as a result of patient enrollment in an institutional review board approved clinical trial
S9992	Transportation costs to and from trial location and local transportation costs (e.g., fares for taxicab or bus) for clinical trial participant and one caregiver/companion
S9994	Lodging costs (e.g., hotel charges) for clinical trial participant and one caregiver/companion

Applicable ModifiersModifier

Q0	Investigational clinical service provided in a clinical research study that is in an approved clinical research study
Q1	Routine clinical service provided in a clinical research study that is in an approved clinical research study

No specific codes identifiedmixed

No codes listed

CPT CodesCPT

No codes listed

HCPCS CodesHCPCSCovered

S9124	Nursing care, in the home; by registered nurse, per hour
T1000	Nursing care, in the home; by licensed practical nurse, per hour
Private duty/independent nursing service(s)	licensed, up to 15 minutes (listed without a numeric code in document)

inv-25: Routine costs coverage — All items and services otherwise generally available to beneficiaries provided in either experimental or control arms

DefinitionAll items and services otherwise generally available to beneficiaries that are provided in either the experimental (treatment) or control (standard of care/placebo) arms of an approved clinical trial.

ApplicabilityApplies when an approved clinical trial meets CED/CSP/CAD conditions and the service is not statutorily excluded or subject to a national non‑coverage decision.

Examples includedRoutine inpatient/outpatient services, diagnostics, and other clinically indicated care that would be covered outside the trial when provided as part of either arm.

ExclusionsInvestigational items/devices used solely for data collection and analysis, items provided free by trial sponsors, and travel/ lodging/meal costs are not routine costs.

Billing noteRoutine costs are payable for both experimental and control arms; use applicable clinical trial modifiers (Q0/Q1) where indicated.

Provider Requirements, Prior Authorization, Documentation

Prior Authorization

Registry/Study Participation Required for Coverage

When a CMS National Coverage Determination (NCD) requires Coverage with Evidence Development (CED), providers must ensure patients are enrolled in the required registry or study for coverage to apply. CAD (Coverage with Appropriateness Determination) and CSP (Coverage with Study Participation) conditions imposed by CMS must be met, including submission of specified data to registries that conform to accepted standards (qualified scientific oversight, validated data collection, patient safety/monitoring, quality assurance, data protection, and human subjects protections). Providers should confirm registry participation and adhere to the NCD-specified eligibility and provider training/credential requirements before providing the service.

Providers must enroll patients in the required registry or study when an NCD mandates CED.
Registries must meet CMS standards for scientific oversight, validated data methods, safety monitoring, QA, data protection, and human subjects protections.
Coverage limited to patients who meet protocol requirements and to providers/sites specified in the NCD.

Billing Rule

Modifiers and Network Participation

Use applicable modifiers to indicate services provided in the context of clinical research: Q0 for investigational clinical services provided in an approved clinical research study, and Q1 for routine clinical services provided in an approved clinical research study. Network participation rules apply: if network providers participate in the trial and will accept the member, the Qualified Individual must use an in-network provider; Select Health may deny or limit payment for routine patient services if an approved clinical trial is conducted out-of-state.

Applicable modifiers: Q0 = investigational clinical service; Q1 = routine clinical service in an approved study.
If one or more network providers participate and will accept the member, the member must use an in‑network provider for trial services when network benefits apply.
Select Health may deny or limit payment for routine services when an approved clinical trial is conducted outside the member's state of residence.

Prior Authorization

PDN Prior Authorization and Case Management

Private duty nursing (PDN) requires prior authorization and active case management. PDN is intended as temporary, skilled transitional care (typically not exceeding 3 months) to assist transition from inpatient to home and to train caregivers; ongoing permanent PDN is not intended. Coverage is dependent on the member's specific benefits and medical necessity under the plan.

PDN requires preauthorization—confirm benefits and authorization with the member's plan at time of service.
PDN is intended for temporary transitional skilled care (usually not to exceed ~3 months) to train caregivers; long‑term/permanent PDN is generally not covered.
Coverage depends on member benefits and medical necessity; providers should verify eligibility before initiating services.

Billing Rule

Prior Authorization and Billing

PDN and other trial‑related services must be billed using appropriate codes and modifiers; PDN is typically billed hourly (examples: S9124, T1000). Providers must verify benefits and obtain preauthorization before billing. Routine patient costs in approved clinical trials are payable when consistent with the member's benefit and not otherwise excluded; items provided solely for data collection, the investigational item itself, sponsor‑provided items, travel, and out‑of‑network routine costs where non‑network benefits do not exist are excluded.

PDN billing is hourly (examples: S9124, T1000) — confirm applicable codes per contract.
Use Q0/Q1 modifiers when billing research‑related services as applicable.
Verify member benefits and obtain preauthorization prior to service; routine trial costs are covered only when consistent with plan benefits and not excluded.
Excluded from coverage: the investigational item/device itself; items solely for data collection; sponsor‑provided items; travel/lodging; routine costs obtained out‑of‑network when non‑network benefits are not available.

Note

Coverage Determination May Follow CMS NCDs

Select Health follows CMS coverage determinations where applicable: when CMS has issued an NCD, that determination guides coverage. If an NCD requires CED (CAD or CSP) the CMS conditions (including registry or study participation and any patient/provider restrictions) must be satisfied for coverage to apply under Select Health policies.

When CMS has an applicable NCD, Select Health defers to the CMS determination for coverage.
If an NCD requires CAD or CSP, only patients/providers meeting the NCD conditions (including registry/study participation) will be covered.

Denial Risk

Category A Exclusion

Select Health does NOT cover Category A investigational devices (experimental). Only Category B IDE devices may be considered for coverage, and then only when all documentation requirements are met and the device is used per the approved study protocol at participating sites/providers.

Category A (experimental/investigational) devices are excluded from coverage.
Category B devices may be covered only when: device has Category B FDA status; is used as part of an IDE study supporting an FDA PMA; the study has IRB approval; device is used by a participating Select Health provider and, if required, at a contracted facility.
Coverage of Category B devices is limited to beneficiaries meeting the IDE protocol requirements.

Denial Risk

Denial Triggers

Services may be denied if they do not meet medical necessity per Utah State Rule R590-233-3(17) or are specifically excluded by the member's contract. Denial risk also includes: services provided outside required medical supervision, permanent ongoing PDN when only temporary skilled care is indicated, failure to meet NCD/CED protocol or registry participation requirements, use of Category A devices, and items/services provided solely for data collection or clearly inconsistent with accepted standards of care.

Denial triggers: services not medically necessary per Utah Rule R590-233-3(17) or excluded by contract.
Denial triggers: failure to meet NCD/CED protocol enrollment or registry submission requirements.
Denial triggers: coverage of Category A devices, permanent PDN when temporary skilled care is indicated, services lacking medical supervision, and items solely for data collection.

Documentation Required

Documentation Required for Category B IDE Coverage

Documentation is required for coverage of Category B IDE devices and Category B IDE participation. Providers must supply documentation that the device has Category B FDA status, the investigational study is IRB‑approved, the device is used as part of an FDA‑recognized investigational study supporting a PMA or 510(k) as applicable, and that the provider/site is an approved study participant. Select Health may request trial protocol, IRB approval, and other trial documentation at any time.

Required documentation: evidence of Category B IDE status from FDA.
Required documentation: IRB approval and trial protocol documentation.
Required documentation: evidence that the device is used within an approved investigational study and that the provider/site is authorized to participate; Select Health may request documentation to verify safety and efficacy data.

Note

CAD May Restrict Coverage to Patients Meeting Specific Criteria

CAD may restrict coverage to patients meeting specific clinical criteria and to providers with specified training or credentials. When invoked, CAD requires that only patients included in the approved data collection and treated by qualified providers/sites will be covered. Providers should confirm any patient‑level criteria and provider credentialing/training requirements specified in the NCD before proceeding.

CAD may limit coverage to patients who meet defined clinical criteria in the NCD.
CAD may limit coverage to providers with specific training or credentials and to specified sites.
When CAD is required, only patients included in the required data collection are eligible for coverage.

Step Therapy

Not Applicable — No Step Therapy in This Section

Step therapy rules are not applicable in this section.

No step therapy requirements stated for investigational device or clinical trial coverage in this section.

Note

Appropriate Sequencing of Care (PDN)

Appropriate sequencing of care: PDN is intended to bridge acute inpatient care to the home setting and to teach caregivers until the recipient is stabilized; it is intended as temporary skilled care rather than permanent ongoing care. Providers should ensure PDN is used as a transitional service and document progression toward caregiver independence and medical stabilization.

PDN is for transitional skilled nursing to support discharge from acute settings and to train caregivers.
PDN is temporary and should not be continued as permanent ongoing care; document progress and rationale for duration.
Confirm that PDN aligns with the appropriate sequence of care and medical supervision requirements.

Background and Context

Coverage with Evidence Development (CED) is a CMS paradigm where certain items or services are covered only in the context of approved clinical studies or when additional data collection is required to determine whether the service is reasonable and necessary. CMS has used CED to permit conditional coverage while evidence is generated, applying safeguards such as trial registration, human subjects protections, and requirements for scientific integrity and public reporting of outcomes.

Key Definitions

inv-47: Coverage with Appropriateness Determination (CAD) definition — A CED approach where coverage is provided only if additional data (beyond claims) are collected to ensure items/services are provided to ...

TermCoverage with Appropriateness Determination (CAD)

DefinitionA CED approach where coverage is provided only if additional clinical data (beyond claims) are collected to ensure the item/service is provided to appropriate patients and/or by appropriately credentialed providers as specified in the NCD.

When invokedInvoked when CMS determines evidence is adequate for coverage but requires extra data because claims data alone are insufficient to ensure appropriate use (e.g., restrict to patients with specific criteria or providers with specific credentials).

Data requirementsData must be submitted to registries/databases that conform to accepted standards (scientific oversight, validated collection methods, patient safety/monitoring, quality assurance, data protection, and human subjects protections).

inv-48: Coverage with Study Participation (CSP) definition — A CED approach allowing coverage only for patients enrolled in qualified clinical research studies when existing evidence is insufficient...

TermCoverage with Study Participation (CSP)

DefinitionA CED approach allowing coverage only for patients enrolled in qualified clinical research studies when existing evidence is insufficient for standard coverage and additional data are required in a research context.

When appliedApplied when evidence is inadequate to determine reasonable and necessary status and coverage may be provided within trials that include added safety, monitoring, and patient protections.

AuthorityCSP is based on section 1862(a)(1)(E) and may be used to allow coverage during evidence development when criteria for research oversight and trial quality are met.

inv-49: Category A IDE — Experimental/investigational device definition

TermCategory A IDE (Experimental/Investigational)

DefinitionNovel, first‑of‑a‑kind technologies for which the absolute risk and initial questions of safety and effectiveness have not been established; considered experimental under FDA/IDE classification.

Coverage stanceCategory A devices are not covered under SelectHealth and will be denied as experimental/investigational.

Regulatory noteCategory A describes devices believed to be Class III or for which incremental/absolute risk remains unresolved and require full safety/effectiveness evaluation.

inv-50: Category B IDE — Non-experimental/investigational device definition

TermCategory B IDE (Non‑experimental/Investigational)

DefinitionDevices that are newer generations or evolutionary changes of proven technologies where initial safety questions are largely resolved; may be eligible for limited coverage when used per protocol in an approved investigational study.

Coverage conditionsCoverage may be allowed only when the device has Category B FDA status and is used in an investigational study supporting FDA review and meeting protocol/site/provider requirements.

LimitationCoverage is restricted to beneficiaries meeting the study protocol and participating at approved investigational sites/providers.

inv-51: Approved Clinical Trial / Qualified Individual — Approved clinical trials are federally funded, FDA IND, or meet specified peer-review criteria; a Qualified Individual is covered under t...

Approved clinical trialTrials considered 'approved' include federally funded trials, those with an FDA IND, or peer‑reviewed non‑governmental trials meeting specified criteria; trials must have a written protocol and IRB approval.

Qualified IndividualA Qualified Individual must be covered under the health plan and eligible to participate according to the trial protocol, either by in‑network referral or by providing medical/scientific information demonstrating eligibility.

Network participationIf network providers participate in the trial and will accept the participant, the Qualified Individual must use a network provider; SelectHealth may limit payment for out‑of‑state trials.

Routine costsRoutine patient costs for approved clinical trials are payable for both experimental and control arms when trial meets approval criteria.

inv-52: Private Duty Nursing (PDN) definition — Provision of medically necessary, complex skilled nursing care in the home on an hourly basis by an RN or LPN to assess, monitor, provide...

DefinitionPrivate Duty Nursing (PDN): provision of medically necessary, complex skilled nursing care in the home on an hourly basis by an RN or LPN to assess, monitor, provide skilled care, and teach caregivers during transition from inpatient to home.

PurposeIntended to bridge hospital care and home, assist transition, deliver skilled nursing functions, and train family caregivers until the recipient is stabilized.

DurationUsually temporary in nature and not intended to be permanent ongoing care; typically provided for a defined period, usually not to exceed 3 months.

SupervisionPDN is provided under medical supervision and billed on an hourly basis (RN/LPN); example HCPCS codes include S9124 (RN) and T1000 (LPN).

inv-53: Medical necessity (Utah State Rules) — Health care services/products a prudent professional would provide to prevent, diagnose or treat illness in a manner that is clinically a...

Clinical appropriatenessMust be appropriate in terms of type, frequency, extent, site, and duration and based on scientific evidence for interventions not yet in widespread use.

Contract requirementServices must be covered under the member's contract to meet medical necessity definition.

Decision factorsFor established interventions, effectiveness is based on scientific evidence, professional standards, and expert opinion.

inv-54: Private Duty Nursing (PDN) alternate definition entry — Private duty nursing: provision of medically necessary, complex skilled nursing care in the home by an RN or LPN on an hourly basis, unde...

Alternate PDN definitionPrivate duty nursing: provision of medically necessary, complex skilled nursing care in the home by an RN or LPN on an hourly basis, under medical supervision, to assess, monitor, provide skilled care, and train caregivers during transition from inpatient to home.

Temporary naturePDN is usually temporary and not intended as permanent ongoing home nursing; service duration depends on clinical need and stabilization of the recipient.

Billing notePDN is billed on an hourly basis with example HCPCS codes S9124 (RN) and T1000 (LPN); benefits and preauthorization should be confirmed with the member's plan.

IntentProvides skilled constant attention and observation to seriously ill recipients and supports caregiver training until care can be transitioned.