AST GVT Medicare Approved Path Labs


On Dec. 20, AST GVT issued rules on health insurance laboratories.


  • AST GVT issued the Health insurance (accredited pathology laboratories-approval) amendment (relevant standards) principles (no 2) 2021 in force Jan. 1, Feb. 1, 2022.
  • Purpose
  • Health insurance act 1973 S 23DNA provides for Minister for Health to determine the principles to be applied in exercising powers under S 23DN of the 1973 Act to approve in principle, or refuse to approve, premises as an accredited pathology laboratory.
  • Amendments are being made to the current principles: namely the Health insurance (accredited pathology laboratories – approval) principles 2017 (the Principles).
  • Payments for Medicare benefits for pathology services are generally only payable when they are rendered by or on behalf of an approved pathology practitioner, in an accredited pathology laboratory operated by an approved pathology authority.
  • The Principles under S 23DNA ensure appropriate standards are met and maintained in pathology laboratories at which Medicare eligible pathology services can be provided.
  • The amendments incorporate the following revised and new accreditation standards.
  • From Jan. 1, 2022 requirements for use of digital images as an alternative to direct microscopy (1st Ed. 2021) and requirements for point of care testing (2nd Ed. 2021).
  • From Feb. 1, 2022 the requirements for procedures related to the collection, processing, storage and issue of human haemopoietic progenitor cells (6th Ed. 2021).
  • Feb. 2022 Compilation of 2017 Principles
  • On Feb. 7, 2022, AST GVT registered compilation no. 8 of Health insurance (accredited pathology laboratories – approval) principles 2017, text as in force Feb. 1, 2022. Includes amendments made by the amendment principles (no 2) 2021 which are set out above, and makes note of amendments which have not yet been incorporated.
  • This compilation supersedes compilation no. 7 of the 2017 principles, which was registered on Feb. 1, 2022 and set out the law as in force prior to compilation no. 8.
  • Apr. 2022 Amendments
  • On Apr. 21, 2022, AST GVT registered the Health insurance (accredited pathology laboratories—approval) amendment (relevant standards) principles (no. 1) 2022.
  • Instrument amends the 2017 principles above, to incorporate revised Requirements for the Retention of Laboratory Records and Diagnostic Material (Ninth Edition 2022).
  • In force day after registration (ie Apr. 22, 2022) and due to sunset on Oct. 1, 2032.
  • Apr. 29, 2022 Compilation No. 9
  • On Apr. 29, 2022, AST GVT registered 9th compilation of Health insurance (accredited pathology laboratories: approval) principles 2017, showing text in force Apr. 22, 2022.
  • Compilation issued to incorporate changes made by amending instrument registered Apr. 21, 2022, the effect of which is noted above; lists changes not yet incorporated.
  • Aug. 2022 Compilation No. 10
  • On Aug. 4, 2022, AST GVT registered 10th compilation of Health insurance (accredited pathology laboratories: approval) principles 2017, shows text as in force Aug. 1, 2022.
  • Compilation issued to reflect commencement of a 2021 amending instrument, which amended the 2017 principles to reflect revised and new accreditation standards.
  • Feb. 2023 Amendments
  • On Feb. 23, 2023, AST GVT registered the Health Insurance (Accredited Pathology Laboratories—Approval) Amendment (Relevant Standards) Principles (No. 1) 2023.
  • Amend the 2017 Principles above to incorporate four revised accreditation standards and two minor administrative amendments, with effect from Mar. 1, 2023.
  • Apr. 2023 Amendments Registered
  • On Apr. 20, 2023, AST GVT registered the Health insurance (accredited pathology laboratories - approval) amendment (relevant standards) principles (no. 2) 2023.
  • Amends the Health insurance (accredited pathology laboratories - approval) principles.
  • Namely, to incorporate revised pathology accreditation standard Requirements for laboratory testing for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) (fourth edition 2023); the whole of this instrument commences on May 1, 2023.
  • May 2023 Compilation No. 12
  • On May 2, 2023, AST GVT registered 12th compilation of Health insurance (accredited pathology laboratories - approval) principles 2017; shows text as in force May 1, 2023.
  • This compilation supersedes the 11th compilation, and is issued to reflect changes made by the Health insurance (accredited pathology laboratories - approval) amendment (relevant standards) principles (no. 2) 2023, as further described above.
  • Jul. 2023 Minor Revision
  • On Jul. 26, 2023, AST GVT registered the Health insurance (accredited pathology laboratories—approval) amendment (relevant standards) principles (no. 3) 2023.
  • Amends the 2017 principles detailed above, as from Aug. 1, 2023, by incorporating references to a revised pathology accreditation standard into the 2017 principles.
  • Jan. 2024 Amendments re Standards
  • On Jan. 30, 2024, AST GVT registered the Health insurance (accredited pathology laboratories - approval) amendment (relevant standards) principles (no.1) 2024 re above.
  • Repeals 3 accreditation standards re cervical screening; amendment in force Aug. 1.
  • In addition, AST GVT published an explanatory statement with respect to the same.
  • It achieves these three repeals by making several amendments to schedule 1 to the Health insurance (accredited pathology laboratories - approval) principles 2017.
  • Other amendments on incorporation of new pathology standard re cervical screening.

Regulators AST GVT
Entity Types IB; IHC; Ins
Reference Info, RF F2024L00107, 1/30/2024; RF F2023L01032, 7/26/2023; RF F2023C00395, 5/2/2023; RF F2023L00454, 4/20/2023; RF F2023L00134, 2/23/2023; RF F2022C00777, 8/4/2022; RF F2022C00498, 4/29/2022; RF F2022L00621, 4/21/2022; RF F2022C00167, 2/7/2022; RF F2022C00149, 2/1/2022; RF F2021L01850, 12/20/2021;
Functions Claims/Accelerated Benefits; Compliance; Financial; Legal; Product Administration
Countries Australia
Category
State
Products Critical Illness; Insurance; Insurance-Health
Regions AP
Rule Type Final
Rule Date 12/20/2021
Effective Date 8/1/2024
Rule Id 124805
Linked to N/A
Reg. Last Update 1/30/2024
Report Section International

Last substantive update on 01/31/2024