ModifiedSelectHealthPolicy 616

Coverage with Evidence Development

Defines SelectHealth's policy for conditionally covering items and services when provided within approved clinical studies or with required data collection, applying to commercial, Medicare, and CHIP/Medicaid beneficiaries when CMS requirements or equivalent criteria are met.

Policy Summary

PayerSelectHealth

PolicyCoverage with Evidence Development

Policy CodePolicy 616

Change TypeMaterial revision to coverage criteria

Effective DateSep 1, 2023

Next Review DateFeb 14, 2025

Key ActionObtain prior authorization and document trial eligibility, active case management, InterQual SNF criteria, and trial registration as required for coverage.

SourceLink

POLICY UPDATE CHANGES

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

27NCDs requiring CED (2 decades)

>120CED studies approved

CoveredRoutine trial costs stance

3 monthsPDN transition target

Not coveredCategory A devices

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Coverage Criteria — Coverage with Evidence Development (CED)

General Guidelines Requirements for Coverage with Evidence Development

Covered when ALL of the following are met

General CED study requirements: 1. The principal purpose of the study is to test whether the item/service meaningfully improves health outcomes of affected beneficiaries represented by enrolled subjects; 2. The study rationale 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 enrollment is sufficient to answer the research questions; 5. Study is sponsored by an organization or individual capable of completing it successfully; 6. The study complies with applicable federal human subjects protections (45 CFR Part 46 and, if FDA-regulated, 21 CFR Parts 50 and 56) and obtains meaningful informed consent; 7. All aspects of the study are conducted according to appropriate standards of scientific integrity; 8. A written protocol demonstrates adherence to Medicare requirements; 9. The study is not designed solely to test toxicity in healthy individuals except in life‑threatening conditions with no viable treatment options; 10. The study/registry is registered on ClinicalTrials.gov (and registries on AHRQ RoPR when applicable); 11. The protocol specifies methods and timing for public release of prespecified outcomes (results made public within 12 months of primary completion) including adverse events and analyses; 12. The protocol explicitly discusses affected beneficiary subpopulations and underrepresented groups and plans for retention/reporting; 13. The protocol addresses generalizability of results to beneficiary subpopulations.

All items listed in policy as general guideline requirements

Coverage with Appropriateness Determination (CAD)

CAD applies when evidence supports coverage but additional non-claims data is needed; coverage only for patients included in data collection

CAD conditions: CMS may require Coverage with Appropriateness Determination (CAD) when evidence is adequate to determine an item/service is reasonable and necessary under section 1862(a)(1)(A) but additional clinical data not routinely available on claims is needed to ensure appropriate provision; providers must submit extra data to databases or registries that meet CMS 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.

Coverage with Study Participation (CSP)

CSP applies when evidence is inadequate for standard coverage and coverage is limited to patients enrolled in qualifying research studies

CSP conditions: Coverage with Study Participation (CSP) allows coverage when evidence is inadequate to support coverage under section 1862(a)(1)(A) but adequate study design, protections, and monitoring exist such that items/services may be provided within a research setting; CMS may reimburse routine costs and items/services necessary for the study for Medicare beneficiaries enrolled in qualifying clinical research that meets standards for a qualified trial; trials should be scientifically well supported, not unjustifiably duplicative, follow federal human subjects protections, be representative of the Medicare population when applicable, and be registered in clinical trial databases.

CSP may include observational and broader study designs provided they meet the Clinical Research Policy standards.

Rare CSP Appropriateness Criteria

CSP may be appropriate if ALL following rare conditions are met

Rare CSP appropriateness criteria: a. The available evidence includes assurance of basic safety; b. The item/service has high potential to provide significant benefit to Medicare beneficiaries; c. There are significant barriers to conducting clinical trials.

Used only in rare instances per policy.

Coverage of Control Groups and Placebos in CED Studies

Controls and placebos may be covered under section 1862(a)(1)(E) when necessary for scientific validity

Control group coverage rationale: Placebo or standard-of-care control arms may be covered under statutory authority (e.g., section 1862(a)(1)(E)) when necessary to preserve the scientific integrity of a clinical study; although placebo/control services may lack direct therapeutic benefit and not be reasonable/necessary under 1862(a)(1)(A), they can be necessary for valid evaluation (e.g., blinding/masking) and routine costs for both experimental and control arms are payable under CED when appropriate.

Explains rationale for covering non-therapeutic controls in qualifying studies.

CED core trial coverage criteria

Coverage with Evidence Development: trials are covered when ALL of the following core criteria are met

CED core criteria: 1. Primary purpose is to test whether the intervention potentially improves participants' health outcomes; 2. Trial is well-supported by scientific and medical information or intended to clarify outcomes of commonly used interventions; 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/individual capable of execution; 6. Trial follows federal human subjects protections; 7. All aspects conducted per appropriate standards of scientific integrity; 8. Trial is listed in the National Library of Medicine clinical trials database; 9. Sample includes individuals representative of the Medicare population described in the NCD.

From CED requirements

Control arms and placebo coverage under CED

Control groups and placebo: coverage guidance

Control and placebo coverage: Placebo or standard-of-care control items/services, though lacking direct health benefit, can be covered when necessary to preserve the scientific validity of a clinical study under statutory authority (including alternative Part B payment methods where masking is required); routine costs in both experimental and control arms are paid under CED when appropriate.

Explains rationale and payment authority

Category B IDE 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 used as part of an investigational study for an FDA PMA application; 3. The investigational study has IRB approval (by Intermountain Health as specified); 4. Device is used by a participating Select Health provider; 5. If hospital use is required, the device must be administered at a contracted facility; 6. Select Health will evaluate safety data to determine if adequate data supports safety/efficacy.

All items required for coverage

Routine Patient Costs Coverage Criteria

Covered when ALL of the following are met

Qualified individual and trial criteria: 1. Member is covered under the health plan and eligible to participate in an approved clinical trial per the trial protocol; 2. The trial is Phase I–IV, related to prevention/detection/treatment of cancer or other life‑threatening disease/condition, and meets the investigational trial criteria (e.g., federally funded, IND-reviewed by FDA, or IND-exempt drug trials as applicable).

Network participation may be required if network providers are conducting the trial

Trial administrative requirements: 1. The clinical trial must have a written protocol and be approved by relevant IRBs prior to enrollment; Select Health may request supporting documentation about the trial.

Private Duty Nursing — Coverage Criteria

Covered when ALL of the following are met

PDN coverage preconditions: 1. The patient is under active case management with Select Health; 2. The member is ventilator or tracheostomy dependent; 3. The member meets InterQual guidelines for SNF; 4. The primary care physician or specialist has agreed to the home care plan; 5. Placement of the nurse is for the care and benefit of the member with a skilled need only; 6. The member and family acknowledge that this service is temporary as a transition to an alternative care environment.goal: transition off nursing within ~3 months

Coverage hour guidance provided for ventilator and tracheostomy dependent members; maximum hours intended for PRN acute exacerbations.

Coverage Criteria (Commercial & CHIP)

Covered when ALL of the following are met:

Private Duty Nursing Coverage Criteria: 1. The patient is under active case management with Select Health; 2. The member is ventilator or tracheostomy dependent; 3. The member meets InterQual guidelines for SNF; 4. The primary care physician or specialist has agreed to the home care plan; 5. Placement of the nurse is for the care and benefit of the member with a skilled need only; 6. The member and family acknowledge that this service is temporary as a transition to an alternative care environment.goal: transition off nursing within 3 months

Maximum hours schedules provided for ventilator and tracheostomy dependent members; maximums intended for PRN use during acute exacerbations.

Product Line Determination

Line-specific determination rules:

Medicare and Medicaid application: For Medicare members, coverage is governed by CMS determinations; if CMS has not adopted a determination and InterQual criteria are not available, the Select Health Commercial policy applies. For Select Health Community Care (Medicaid), policies typically align with Utah Medicaid and use InterQual; NCD/LCD or Select Health commercial policies may be applied as appropriate.apply product-specific rules

Providers should consult CMS or state Medicaid resources for the most up-to-date rules.

Items and services that are experimental or investigational remain non‑covered unless provided within a qualifying CED/CSP study or registry that meets the policy's CED requirements. Select Health follows the CED framework that conditions coverage on provision within approved clinical studies or when additional clinical data is being collected to evaluate appropriateness and outcomes for beneficiaries.

Select Health explicitly does NOT cover Category A investigational devices. Category A devices meet the plan's definition of experimental/investigational and are excluded from coverage under this policy.

Items or services provided solely to satisfy study data collection and analysis requirements — and not used in the direct clinical management of the patient — are excluded from coverage. Examples include protocol‑driven laboratory tests or imaging performed at frequencies not consistent with clinical signs/symptoms or established standards of care.

Routine patient costs obtained from out‑of‑network providers are excluded when the member's plan does not provide non‑network benefits. Providers and members should verify benefits and eligibility, as coverage for routine trial costs depends on the member's individual benefit plan in effect at the time of service.

Certain HCPCS‑billed items commonly associated with clinical trial participation are explicitly listed as not covered. Examples shown in the policy include G9057, S9992 (transportation), and S9994 (lodging). Travel and lodging expenses and items provided free by sponsors are noted exclusions and should not be billed as routine covered services.

Private duty nursing (PDN) is intended as a temporary, transitional skilled nursing service to support discharge and caregiver training; it is not intended to be a permanent, ongoing service. Long‑term or permanent PDN without demonstrated acute skilled need is excluded from coverage.

When the available evidence is inadequate to determine that an item or service is reasonable and necessary under section 1862(a)(1)(A), the item or service is not considered reasonable and necessary for Medicare coverage except when provided within a qualifying CSP/CED study under the statutory authority that permits coverage of routine costs for research when appropriate protections and study design exist.

Coverage is always subject to the member's individual benefit plan and eligibility determinations. Inclusion of codes or services in this policy does not guarantee payment for a specific member — providers and members must check the member's contract benefits and verify eligibility before assuming coverage.

Services provided beyond the intended temporary, transitional need for PDN are not consistent with coverage under this policy. Coverage for PDN is contingent on demonstration of an acute, skilled need and a goal of transition (typically within 3 months) to alternative care; ongoing permanent nursing care without these criteria is excluded.

Coding — Relevant Billing Codes and Modifiers

CPT and HCPCS codes referencedmixed

Too numerous to list / No specific codes identified

CPT and HCPCS codes are noted as too numerous to list or none identified in this section.

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.

HCPCS Codes that may be coveredHCPCSCovered

S9988	Services provided as part of a Phase I 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 a 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

HCPCS Codes 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 (for use in a medicare-approved demonstration project)
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

HCPCS codes that may be covered if criteria metHCPCSCovered

S9988	Services provided as part of a Phase I 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 a 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

HCPCS codes 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 (for use in a medicare-approved demonstration project)
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

HCPCS CODESHCPCSCovered

S9123	Nursing care, in the home; by registered nurse, per hour
S9124	Nursing care, in the home; by licensed practical nurse, per hour
T1000	Private duty/independent nursing service(s), licensed, up to 15 minutes

CPT CODESCPT

No codes listed

NLM clinical trials registration

RequirementTrial must be listed in the National Library of Medicine clinical trials database (ClinicalTrials.gov)

PurposeEnsures transparency, public registration, and identification of trial details required by CED criteria

ApplicabilityApplies to trials submitted for Coverage with Evidence Development (CED) determinations

Private duty nursing transition goal

GoalTransition the patient off private duty nursing within 3 months of admission to home

Provider Actions — Authorization, Documentation, and Denial Risks

Note

CMS determinations govern Medicare coverage

For Medicare members, coverage decisions are governed by CMS determinations. If CMS has not issued a coverage determination and InterQual criteria are not available, the SelectHealth Commercial policy applies; providers should consult CMS and SelectHealth policy sources for the current determination.

Prior Authorization

Category B IDE coverage prerequisites

Category B IDE devices are covered only when all specified conditions are met, including FDA Category B status, use as part of an FDA PMA investigational study, IRB approval, use by a participating Select Health provider, administration at a contracted facility when hospital use is required, and Select Health evaluation of safety data.

Device has attained Category B FDA status
Used as part of an investigational study for an FDA PMA application
Investigational study has IRB approval
Device is used by a participating Select Health provider

Background — Policy Context and Scope

Coverage with Evidence Development (CED) permits conditional coverage of items and services when furnished within approved clinical studies or when required data collection is performed. Under CED, routine costs and necessary study‑related services may be covered provided the study meets the policy's requirements for scientific validity, human subjects protections, registration, and public reporting of outcomes.

Definitions

CAD — Coverage with Appropriateness Determination (CAD)

DefinitionCoverage with Appropriateness Determination (CAD): coverage provided when evidence supports use but additional non-claims data is required

Coverage conditionOnly items/services for patients included in the required data collection are covered under CAD

Registry standardsRegistries must have qualified scientific oversight, validated data methods, patient safety/monitoring, QA, data protection, and human subjects protections

CSP — Coverage with Study Participation (CSP)

DefinitionCoverage with Study Participation (CSP): coverage limited to patients enrolled in qualifying research studies when evidence is inadequate for standard coverage

AuthorityCSP uses section 1862(a)(1)(E) authority to provide coverage while evidence is developed in research settings

Revision History

Policy Summary

PayerSelectHealth

PolicyCoverage with Evidence Development

Policy CodePolicy 616

Change TypeMaterial revision to coverage criteria

Effective DateSep 1, 2023

Next Review DateFeb 14, 2025

Key ActionObtain prior authorization and document trial eligibility, active case management, InterQual SNF criteria, and trial registration as required for coverage.

SourceLink

On This Page

IntentPDN serves as a temporary bridge from inpatient care to home while training family caregivers

DocumentationMember and family must acknowledge that PDN is temporary as a transition to an alternative care environment

Target transition period

Target periodPDN goal to transition off service within 3 months of admission to home

Typical useProvided for a defined timeframe throughout a 24-hour period to support transition from inpatient care to home

Maximum hours guidanceMaximum hours permitted for ventilator/tracheostomy dependent members are to be used PRN during acute exacerbations per policy

If hospital use required, device administered at a contracted facility

Select Health will evaluate safety/efficacy data

Prior Authorization

Coverage requires plan eligibility and qualifying trial documentation

Routine patient costs for qualifying individuals in approved clinical trials are covered only when the member is covered under the plan and eligible per the trial protocol; documentation of trial eligibility and adherence to trial requirements must be available.

Member must be covered under the health plan and eligible for the trial per protocol
Trial must be Phase I–IV and meet applicable trial criteria
Written protocol and IRB approval may be requested

Prior Authorization

Private duty nursing — authorization conditions

Private duty nursing coverage requires the patient to be under active case management with Select Health and the primary care physician or specialist to agree to the home care plan; coverage is intended for a defined transitional period.

Active case management with Select Health is required
Primary care physician or specialist must agree to the home care plan
Service intended as an acute transition from inpatient to home

Prior Authorization

Authorization requirement

Prior authorization is required based on the member's benefit determination and the policy coverage criteria; coverage for services such as PDN is limited to the acute transition period and contingent on meeting the listed criteria.

Obtain prior authorization per member benefit plan
Coverage contingent on meeting policy criteria (e.g., ventilator/tracheostomy dependence, InterQual SNF)

Step Therapy

Data submission requirement under CAD

When CAD is required, only patients included in the specified data collection are covered; providers must submit the extra, non‑claims data to approved registries that meet CMS standards.

Submit extra data to registries that conform to CMS standards (scientific oversight, validated methods, safety/monitoring, QA, data protection, human subjects protections)
Coverage applies only to patients included in the data collection

Billing Rule

Payment for control arm routine costs

Under CED, routine costs for both the treatment and control arms (including placebo when necessary for scientific validity) may be paid when required to preserve the scientific integrity of the study.

Routine costs in experimental and control arms are payable when part of an approved CED study
Alternative payment methods may be used to preserve masking and scientific validity

Billing Rule

Excluded services (not to be billed)

Do not bill the plan for services provided solely for data collection, items provided free by the sponsor, travel, transportation, lodging, or meals—these are excluded from coverage.

Items/services provided solely for data collection and not used in direct clinical management are excluded
Items provided free by research sponsors are not to be billed
Travel, transportation, lodging, and related expenses (e.g., S9992, S9994) are excluded

Step Therapy

Temporary/step-down care expectations

Private duty nursing is intended as temporary, transitional skilled nursing to support transfer to family or another care environment, with a goal of transition off nursing within approximately 3 months.

Goal: transition off nursing within ~3 months of admission to home
Service is temporary and not intended as permanent ongoing care

Note

Therapy intent and expectation

PDN is intended to teach caregivers, stabilize the member's condition, and transition care to less‑intensive settings; services should transition to less-intensive care when appropriate.

Provide skilled nursing to assess, monitor, teach caregivers, and stabilize condition
Plan for transition to less-intensive care once stabilized

Documentation Required

Required study documentation and public reporting

Study protocols must specify the method and timing of public release of prespecified outcomes, and results must be made public within 12 months of the study's primary completion date.

Protocol must detail public release timing/methods and include negative or early-terminated results
Final results reported in a peer‑reviewed journal or publicly accessible registry within 12 months

Documentation Required

Required trial and IDE documentation

Trials and IDEs must meet CED/CSP criteria: clinical relevance, scientific support, non‑duplication, appropriate design, credible sponsor, human subjects protections, registration in ClinicalTrials.gov, and representative sampling; Category B IDEs have additional IDE-specific documentation requirements.

Trial listed in National Library of Medicine clinical trials database
Trial meets scientific, ethical, and design standards described in CED/CSP criteria
Category B IDEs must meet the six IDE-specific conditions

Documentation Required

Protocol and IRB documentation

The clinical trial must have a written protocol and IRB approval prior to participant enrollment; Select Health may request documentation about the trial at any time.

Written protocol describing a scientifically sound study is required
IRB approval must be obtained before enrollment; documentation may be requested

Documentation Required

Verify benefits and eligibility

Providers must verify the member's benefits and eligibility; coverage determinations are based on the member's individual benefit plan in effect at the time services are rendered and may require contacting Customer Service or Provider Relations.

Confirm member coverage and benefits prior to service
Benefits/eligibility determinations take precedence over policy inclusion of codes

Documentation Required

Required clinical documentation

Clinical documentation must demonstrate active case management with Select Health, clinical dependence (ventilator or tracheostomy), InterQual SNF criteria as applicable, physician agreement to the home care plan, skilled nursing need justification, and patient/family acknowledgement that the service is temporary.

Document active case management with Select Health
Show ventilator or tracheostomy dependence and InterQual SNF criteria met
Physician/specialist agreement and member/family acknowledgement of temporary service

Denial Risk

Denial triggers for non-compliance with CED requirements

Coverage is contingent on meeting CMS/Select Health CED criteria; failure to enroll patients in required registries or to comply with protocol or registry standards may result in non‑coverage or denial.

Enroll patients in required registries and submit required data per NCD specifications
Noncompliance with protocol or registry standards may lead to denial

Denial Risk

Exclusion of Category A IDEs

Category A investigational devices are not covered by Select Health; claims for Category A devices will be denied.

Do not submit claims for Category A investigational devices — they are excluded as experimental/investigational

Denial Risk

Denial triggers for out-of-state or out-of-network trials

Select Health may deny or limit payment for routine patient services if an Approved Clinical Trial is conducted outside the member's state of residence or out‑of‑network when the plan has no non‑network benefits.

Trials conducted out-of-state may lead to denial or limited payment
Routine patient costs obtained out-of-network where non-network benefits do not exist are excluded

Billing Rule

Noncovered HCPCS codes

Certain HCPCS codes are explicitly not covered (for example, G9057, S9992, S9994); use of these codes may result in nonpayment or denial when billed.

G9057, S9992, and S9994 are listed as not covered

Denial Risk

Denial triggers related to unmet eligibility or criteria

Coverage depends on the member's benefit coverage at the time of the request; failure to meet Select Health's listed criteria (including active case management, ventilator/tracheostomy dependence, InterQual SNF criteria, physician agreement, skilled need, and acknowledgement of temporary service) may result in denial.

Benefits/eligibility at time of service determine coverage
Failure to meet required PDN or trial criteria may trigger denial

Study requirementsStudies must provide added safety, patient protections, monitoring, and clinical expertise to qualify

Category A — Category A (experimental/investigational) device

Category AExperimental/investigational device: novel, first‑of‑a‑kind technologies where absolute risk and safety/effectiveness are not established

Risk characterizationAbsolute risk of the device type has not been established; initial safety/effectiveness questions unresolved

Coverage stanceCategory A devices are considered experimental and are not covered per policy

Category B — Category B (nonexperimental/investigational) device

Category BNonexperimental/investigational device: devices with initial safety/effectiveness questions resolved or representing evolutionary changes in proven technologies

Risk characterizationIncremental risk is primary issue; device type generally known to be safe/effective

Coverage limitationCoverage of Category B devices may be limited to beneficiaries meeting protocol requirements in approved trials

Approved Clinical Trials — Trials that are Phase I-IV and meet the Section requirements

Phases includedApproved Clinical Trials include Phase I, Phase II, Phase III, or Phase IV trials

ScopeTrials must relate to prevention, detection, or treatment of cancer or other life‑threatening disease or condition

Section II requirementsTrials must meet additional criteria (e.g., federally funded, IND-reviewed by FDA, or IND-exempt drug trials) as specified in policy

Routine Patient Costs — Items and services consistent with coverage typically provided to a qualified individual not enrolled in a clinical trial

DefinitionRoutine Patient Costs: items and services consistent with coverage typically provided to a qualified individual not enrolled in a clinical trial (e.g., office visits, lab tests, supportive care)

ExclusionsDoes not include the investigational item/device itself, data‑collection‑only services, or services inconsistent with established standards of care

Billing implicationRoutine costs may be covered for qualified individuals enrolled in approved clinical trials subject to plan benefits and trial eligibility

Private Duty Nursing (PDN) — Provision of skilled nursing care in the home for a defined time frame throughout a 24-hour period to support transition

DefinitionPrivate Duty Nursing (PDN): provision of skilled nursing care in the home for a defined timeframe throughout a 24‑hour period to support transition from inpatient care to home

PurposeUsed to assess, monitor, provide skilled care, and teach caregivers during transition to home

Typical durationUsually temporary and not to exceed approximately 3 months; intended as transitional rather than permanent care

Medical necessity (Utah State Rules) — Health care services/products a prudent professional would provide consistent with accepted standards

DefinitionMedical necessity (Utah State Rules): services a prudent professional would provide consistent with accepted standards, clinically appropriate in type/frequency/extent/site/duration, not primarily for convenience, and covered under contract

Effectiveness standardsFor interventions not yet in widespread use, effectiveness is based on scientific evidence; for established interventions, on scientific evidence, professional standards, and expert opinion

Decision factorsIncludes consideration of benefits and harms and the most appropriate level of service for the individual

Private Duty Nursing (PDN) definition variant

PDN (alternate wording)Medically necessary, complex skilled nursing care in the home on an hourly fee‑for‑service basis by an RN or LPN to assist transition from inpatient to home, monitor and provide skilled care, and teach caregivers

Service modelHourly fee‑for‑service basis; focused on skilled needs and caregiver training

Temporary intentService is intended to be temporary and not a permanent ongoing service unless medically necessary due to acute skilled needs