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Health Insurance Accredited Pathology Labs Approval Principles 2017

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Summary

The Australian Department of Health issued Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017 under the Health Insurance Act 1973. The principles establish requirements for approval of premises where pathology services are performed, including assessment criteria, approval periods, revocation, and variation procedures. Pathology laboratories seeking Medicarerebate eligibility must comply with these approval standards.

Published by AU Gov on legislation.gov.au . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

The Health Insurance (Accredited Pathology Laboratories—Approval) Principles 2017 establish the regulatory framework for approving premises where accredited pathology services are performed under Medicare. The principles cover the approval process including assessment by independent bodies, conditions for approval without assessment reports, and provisions for state accreditation systems. Part 3 addresses approval of premises, periods of approval, revocation, and variation procedures. Part 4 establishes categories of premises.\n\nAffected parties including pathology laboratory operators, healthcare providers referring patients for pathology services, and patients claiming Medicare rebates for pathology services should monitor compliance requirements. Laboratories must maintain approved premises status to ensure continued eligibility for Medicare billing. State-based accreditation systems may be recognised under the principles, affecting how laboratories in different jurisdictions obtain and maintain approval.

What to do next

  1. Verify pathology laboratory premises comply with current approval standards
  2. Ensure assessment reports meet requirements under Part 3 of the Principles
  3. Review approval period and renewal requirements for compliance

Penalties

Non-compliant laboratories risk approval revocation under Part 3 Division 5 of the Principles, affecting Medicare rebate eligibility.

Archived snapshot

Apr 9, 2026

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Named provisions

Part 1—Introductory Part 2—General Part 3—Approval of premises Part 4—Categories of premises Part 5—Assessor qualifications

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Last updated

Classification

Agency
AU Gov
Published
October 1st, 2017
Instrument
Rule
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
F2026C00298

Who this affects

Applies to
Healthcare providers Government agencies
Industry sector
6211 Healthcare Providers
Activity scope
Pathology laboratory approval Medicare billing compliance Healthcare facility accreditation
Geographic scope
Australia AU

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Insurance Public Health

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