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SB 422

Health Care - As introduced, lowers from every three years to every two years, the time within which the advisory committee composed of medical device industry representatives and a representative of the department of economic and community development must review rules regarding the board of pharmacy's oversight of facilities that manufacture, warehouse, and distribute medical devices in order to review the advancements of new medical device technologies. - Amends TCA Title 8; Title 47; Title 56; Title 63 and Title 71.

114th Regular Session (2025-2026)

Tennessee SB 422 requires health plans to cover prosthetic and custom orthotic devices for ≤21 (later broader) at or above Medicare levels, with specific access, cost-sharing, and

Placed on Senate Finance, Ways, and Means Committee calendar for 4/20/2026
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Bill Summary · SB 422

Summary of SB 422 (Session 114) — Tennessee

Note: The bill as presented in the provided materials appears to be an amended version of the Senate Bill 422 (HB 406 in House) focusing on two distinct policy areas: (1) updating the review schedule for medical device rule oversight, and (2) establishing new requirements for prosthetic and custom orthotic device coverage under health benefit plans. The following summary reflects the full amended text and supporting fiscal materials provided.

1) Main purpose and intent

  • The amendments introduce a comprehensive prosthetic and custom orthotic coverage mandate for health benefit plans offered in Tennessee, targeting non-M TennCare plans for individuals up to age 21 (with later amendments extending certain provisions to younger ages in different versions).
  • Separately, the amendments alter the review schedule for Board of Pharmacy rules related to facilities that manufacture, warehouse, and distribute medical devices, shortening the review interval from every three years to every two years, to monitor advancements in medical device technologies.

2) Key provisions and changes

A. Prosthetic and custom orthotic device coverage (new Section in Title 56, Chapter 7, Part 23)

  • Effective date: Coverage requirements apply to health benefit plans issued, amended, or renewed in Tennessee on or after July 1, 2026 (with phased updates in later versions specifying January 1, 2027 for certain requirements).
  • Covered person: A health benefit plan beneficiary who is 21 years old or younger for the initial requirement; later amendments include provisions applying to younger age groups (e.g., under 17 in some iterations).
  • Coverage standards:
    • Plans must provide prosthetic and custom orthotic device coverage that equals or exceeds Medicare levels and is no more restrictive than coverage for other medical devices under the plan.
    • Coverage must include:
    • The most appropriate prosthetic/orthotic device as determined by the patient's healthcare provider for activities of daily living and essential job tasks.
    • Devices supporting physical activities (e.g., running, cycling, swimming) and overall health and limb function.
    • All materials and components, usage instructions, and repair or replacement.
  • Utilization and eligibility:
    • Treat prosthetic/orthotic coverage as habilitative/rehabilitative benefits for essential health benefits purposes.
    • Apply evidence-based treatment and fit criteria in utilization reviews, per rules established by the commissioner.
    • Ensure nondiscriminatory review and avoid denying benefits based on a patient’s disability.
    • Include rights language in communications regarding coverage decisions.
    • Limit cost-sharing so it does not exceed that for inpatient physician/surgical services.
    • Ensure access to care and devices from at least two in-network providers; if not available, refer to out-of-network providers with full reimbursement at a mutually agreed rate (consistent with in-network cost-sharing).
    • Allow replacement or parts reimbursement without lifetime usage restrictions if specified conditions (e.g., device condition changes, irreparable device changes, or replacements costing more than 60% of a new device) apply.
  • Provider confirmation: The insurer may require confirmation from a prescribing provider if a device replacement is less than three years old.
  • Protections and sanctions:
    • Prohibitions against premium changes or benefit discrimination on the basis of disability; safeguards against denial of prosthetic/orthotic benefits when medically necessary.
    • Sanctions for violations, enforceable by the Department of Commerce and Insurance (DCI).
  • Reporting and data:
    • By January 15, 2027, and annually thereafter, insurers must report specified data to DCI; aggregated, de-identified data to legislative chairs and the Legislative Librarian by January 31 of each year.
  • Exceptions/applications:
    • Does not apply to TennCare/Medicaid programs, CoverKids, Access Tennessee, or certain state employee benefit programs, unless otherwise noted.
  • Legislative rulemaking:
    • DCI may promulgate rules to implement these provisions under the Uniform Administrative Procedures Act.

B. Review cadence for medical device rules (Board of Pharmacy oversight)

  • The advisory committee (composed of medical device industry representatives and a Department of Economic and Community Development representative) must review Board of Pharmacy rules regarding oversight of facilities that manufacture, warehouse, and distribute medical devices every two years (rather than every three years) to consider advancements in new medical device technologies.

3) Affected audiences and entities

  • Health insurers and health benefit plans in Tennessee (excluding TennCare/Medicaid-related programs and certain state-administered plans).
  • Enrolled individuals, particularly children and young adults (up to 21 years old in initial versions; later amendments discuss age-based expansion or limitations).
  • Prosthetic and orthotics providers and manufacturers.
  • Healthcare providers who prescribe prosthetic and orthotic devices.
  • The Department of Commerce and Insurance (DCI) for enforcement, rulemaking, and annual reporting.
  • The Board of Pharmacy and its advisory committee for medical device rule oversight.
  • Employers and health plan sponsors that administer or fund health benefits.

4) Procedural and timeline aspects

  • Effective dates:
    • July 1, 2026: Trigger for coverage requirements for plans issued/renewed in-state that cover pediatric/young adult beneficiaries.
    • In some amendments, January 1, 2027 is used for broader coverage implementation or phase-in, with annual reporting starting thereafter.
  • Reporting:
    • Annual reporting by health insurers to DCI, with aggregated, de-identified data to legislative chairs by January 31 each year.
  • Regulatory authority:
    • DCI given rulemaking authority to implement and enforce these provisions.
  • Fiscal notes:
    • State government expenditures estimated to be in the hundreds of thousands of dollars annually (e.g., around $683,200 in one version), with additional associated costs for local governments, and potential impact on health insurance premiums (noted as an incremental premium increase of less than 1% per covered individual in some estimates).
  • Non-applicability:
    • The bill explicitly excludes TennCare/Medicaid, CoverKids, Access Tennessee, and some state employee programs from the new coverage mandates in certain versions.

5) Potential impact and considerations

  • Access and equity: Expanded coverage for prosthetic and orthotic devices could improve mobility and quality of life for youths with limb loss or congenital conditions.
  • Costs: The added coverage would modestly increase premiums for some plans, though per-member effects are projected to be small (some estimates show less than 1% premium increase).
  • Administrative burden: Insurers must implement new coverage criteria, utilize evidence-based standards, and comply with annual reporting and data sharing.
  • Market effects: Providers may see increased demand for prosthetics and orthotics, with requirements for two in-network providers and potential out-of-network referrals when necessary.

This summary captures the substantive provisions, their effects, and the timeline as reflected in the amended SB 422/HB 406 documents and fiscal analyses.

Compiled from official sources — confirm details with the bill’s official record.

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