Rare Disease and Unexplained Developmental Delay
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Governance of Hennepin Health coverage and authorization processes for services related to rare diseases and unexplained developmental delay, including handling of out-of-network specialty requests and renewals.
No material clinical or coverage changes in this revision.
Coverage Criteria for Rare Disease and Developmental Delay
Initial out-of-network approval logic
Initial approval — out-of-network requests
The UM RN will verify whether the diagnosis is listed on the NIH Rare Disease database; if confirmed as a rare disease, approve for 6 months.
If there is suspicion that the condition may represent a rare disease, Medical Director review is required.
Unexplained developmental delay criteria
Unexplained developmental delay — approval criteria
Denial review and potential overturn
Denied out-of-network claims review
If the Medical Director determines the member has a rare disease, the request for out-of-network coverage will be approved.
Hennepin Health defines rare disease for the purposes of this policy as excluding infectious diseases that have widely available diagnostic and treatment protocols and are commonly managed in primary care settings, even when prevalence is low (i.e., fewer than 200,000 individuals in the U.S.). Coverage determinations remain subject to the member's benefit plan, and prior authorization requirements for out-of-network providers are applied the same as for in-network providers.
Indications Covered Under This Policy
Unexplained developmental delay when criteria (>=2 consultations, documented developmental delay, nondiagnostic/conflicting testing) are met
Covered indication — unexplained developmental delay
Provider Requirements and Actions
Prior authorization: route out-of-network requests to UM RN for NIH rare disease verification
Any out-of-network specialty service request received by UM Administrative staff in the outpatient queue must be routed to the UM RN team for verification against the NIH Rare Disease database; if the diagnosis is confirmed as a rare disease, the request will be approved for 6 months.
- UM RN verifies diagnosis against NIH Rare Disease database (https://rarediseases.info.nih.gov).
- If confirmed as a rare disease, approve out-of-network request for 6 months.
Provider must route out-of-network requests and include supporting consultations/testing
Route out-of-network specialty service requests and any related denials to Utilization Management for RN verification and Medical Director review as required; ensure prior consultation and testing documentation is included with the request.
- Send all out-of-network requests received in the outpatient queue to the UM RN team.
- Include documentation of prior consultations and testing when submitting requests for unexplained developmental delay.
Documentation required for unexplained developmental delay requests
Document in the medical record at least one of: a standardized developmental assessment, developmental regression, failure to thrive, or progressive multisystemic involvement when requesting approval for unexplained developmental delay.
- Ensure the member has had two or more clinical consultations specific to the presenting complaint (see approval criteria).
- Attach laboratory or clinical testing results showing nondiagnostic or conflicting findings.
Route denied out-of-network claims/referrals to UM for RN verification and Medical Director review
Any claim or referral for out-of-network specialty care that is being denied by Provider Services must be routed to the Utilization Management (UM) team for RN verification against the NIH Rare Disease list and review by a Medical Director; if the Medical Director determines the member has a rare disease, approve the out-of-network coverage.
- UM RN will check whether the associated diagnosis appears on the NIH Rare Disease list.
- All denials are reviewed by a Medical Director who may overturn the denial if a rare disease is confirmed.
Policy Eligibility Requirements
To be eligible for approval of out-of-network specialty services for unexplained developmental delay, the referral or claim must meet all policy criteria: the member must have had two or more clinical consultations specific to the presenting complaint; the medical record must document developmental delay by at least one of the following—standardized developmental assessment, developmental regression, failure to thrive, or progressive multisystemic involvement; and laboratory or clinical testing must have been performed and resulted in no definitive diagnosis or conflicting results. Additional review resources are available through the NIH Rare Disease information line at 1-888-205-2311.
Key Definitions
Background and Rationale
This policy requires documentation supporting the clinical determination of unexplained developmental delay. Medical records must demonstrate prior evaluations and objective evidence as described in the approval criteria: at least two clinical consultations, documentation of developmental delay by one of the listed methods, and prior laboratory or clinical testing that is nondiagnostic or yields conflicting results. Claims or referrals that do not meet these eligibility requirements are subject to denial or referral for further review.
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