Conditions for Coverage of Services of Independent Laboratories - Federal Health Insurance for the Aged - Subpart M - Section 405.1301

Sep 21, 2026

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Federal regulations establishing conditions for coverage of services provided by independent laboratories under the Health Insurance for the Aged program. The document defines “independent laboratory” requirements, including independence from attending or consulting physicians’ offices and qualifying hospitals, and clarifies which diagnostic tests qualify for reimbursement. It also outlines relevant standards, certification and compliance evaluation principles, documentation expectations, and specific conditions covering clinical laboratories, laboratory directors, supervision, testing activities, technical personnel, and required records, equipment, and facilities.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages20

Reading Time50 min

AccessFree to download

REGULATIONS

MANUALS

PREFACE

SUBPART M

CONDITIONS FOR COVERAGE OF SERVICES OF INDEPENDENT LABORATORIES

Section 405.1301: Conditions for Coverage of Services; General

# CONDITIONS FOR COVERAGE OF SERVICES OFINDEPENDENT LABORATORIES FEDERAL HEALTH INSURANCEFOR THE AGED (CoDE OF FEDERAL REGULATIONS,TiTLE 20,CHAPTER II,PART 405) # REGULATIONS MANUALS KF 3608 A4 A326 no.13 U.S.DEPARTMENT OF HEALTH,EDUCATION,AND WELFARE 1968 SOCIAL SECURITY ADMINISTRATION KF 3608 A4 4326 no.1 1968 PREFACE Regulations relating to the Health Insurance for the Aged program are published in the FederalRegister and Code of Federal Regulations under Title 20--Employees'Benefits,Chapter II-Social Security Administration,Department of Health,Education,and Welfare.The Code ofFederal Regulations and the Federal Register issues may be purchased from the Superintendentof Documents,Government Printing Office. This Health Insurance Regulations(HIR-13)document sets forth Subpart M of the Social SecurityAdministration's Regulations No.5(Federal Health Insurance for the Aged--Part 405)titled,Conditions for Coverage of Services of Independent Laboratories.Appropriate provisions of theregulations may be cited or shown to the public in reply to questions about the authority for takinga particular action or position in certain matters. SUBPART M ## CONDITIONS FOR COVERAGE OF SERVICESOF INDEPENDENT LABORATORIES SectionConditions for Coverage of Services of Independent Laboratories;General-------_405.1301Conditions for Coverage of Services;General ----__-------_405.1302Standards;General-__405.1303State Agencies ---405.1304Principles for the Evaluation of Independent Laboratories To Determine Whether TheyAre in Substantial Compliance With the Conditions405.1305Time Limitations on Certification of Substantial Compliance -_.405.1306Certification of Noncompliance405.1307Criteria for Determining Substantial Compliance _-_405.1308Documentation of Findings--_405.1309Condition—Compliance With State and Local Laws _-------405.1310Clinical Laboratory;Defined------_405.131lCondition—Clinical Laboratory;Laboratory Director405.1312Condition—Clinical Laboratory;Supervision -----405.1313Condition—Clinical Laboratory;Tests Performed__-__-----------------_-_405.1314Condition—Clinical Laboratory;Technical Personnel __-------------------_405.1315Condition—Clinical Laboratory;Records,Equipment,and Facilities-------------------405.1316 SUBPART M ## Conditions for Coverage of Services of Inde-pendent Laboratories NOTE:§s 405.1301-405.1316 issued under sections1102,1861(s)(10)and(1l),1864,1871,49 Stat.647,as amended,79 Stat.322,79 Stat.326,79Stat.331;42 U.S.C.1302,1395 et seq. 405.1301Conditions for Coverage of Serv-ices of Independent Laboratories;General. (a)Introduction.The Conditions for Coverageof Services of Independent Laboratories and relatedpolicies set forth herein,state the specific require-ments that must be met by an independent labora-tory in order for its services to qualify for reim-bursement under the supplementary medical insur-ance part of the Health Insurance for the Aged pro-gram.The services of a qualified independent lab-oratory for which reimbursement may be made un-der the supplementary medical insurance programrelate only to diagnostic tests performed in a lab-oratory which is independent of a physician's officeor a hospital which meets the conditions of partici-pation in the program.Diagnostic laboratory tests,for purposes of section 1861(s)(10)and(11)ofthe Act and for purposes of this Subpart M,do notinclude diagnostic X-ray tests.(See Subpart R ofthis Part 405 for definition of diagnostic labora-tory tests.) (b)Definition of independent laboratory.An in-dependent laboratory performing diagnostic tests isone which is independent both of the attending orconsulting physician's office and of a hospital whichmeets the conditions of participation in the pro-gram.A laboratory which:(1)Is located in a hos-pital which meets the conditions of participation inthe program or,if outside the hospital,is operatedby or under the supervision of the hospital or its or-ganized medical st

FAQs

What is the purpose of these regulations for independent laboratories?

They set out specific requirements an independent laboratory must meet for its services to qualify for reimbursement under the supplementary medical insurance part of the Health Insurance for the Aged program.

What qualifies as an “independent laboratory” under the document?

A laboratory performing diagnostic tests must be independent of the attending or consulting physician’s office and of a hospital that meets the program’s participation conditions, with specific exclusions described for certain hospital-linked and physician-run labs.

Do diagnostic X-ray tests fall under the qualified diagnostic laboratory tests?

No. Diagnostic laboratory tests under the document do not include diagnostic X-ray tests, which are instead defined elsewhere in the referenced subparts of Part 405.

Sep 21, 2026

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