HR 8890 — Enhancing CLIA Act of 2026

(a) “Laboratory” or “clinical laboratory” defined As used in this section, the term “laboratory” or “clinical laboratory” means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. (b) Certificate requirement No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure. (c) Issuance and renewal of certificates (1) In general The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d). (2) Term A certificate issued under this section shall be valid for a period of 2 years or such shorter period as the Secretary may establish. (d) Requirements for certificates (1) In general A laboratory may be issued a certificate or have its certificate renewed if— (A) the laboratory submits (or if the laboratory is accredited under subsection (e), the accreditation body which accredited the laboratory submits), an application— (i) in such form and manner as the Secretary shall prescribe, (ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory including— (I) the number and types of laboratory examinations and other procedures performed, (II) the methodologies for laboratory examinations and other procedures employed, and (III) the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and (iii) that contains such other information as the Secretary may require to determine compliance with this section, and the laboratory agrees to provide to the Secretary (or if the laboratory is accredited, to the accreditation body which accredited it) a description of any change in the information submitted under clause (ii) not later than 6 months after the change was put into effect, (B) the laboratory provides the Secretary— (i) with satisfactory assurances that the laboratory will be operated in accordance with standards issued by the Secretary under subsection (f), or (ii) with proof of accreditation under subsection (e), (C) the laboratory agrees to permit inspections by the Secretary under subsection (g), (D) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may reasonably require, and (E) the laboratory agrees to treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business, except that no proficiency testing sample shall be referred to another laboratory for analysis as prohibited under subsection (i)(4). (2) Requirements for certificates of waiver (A) In general A laboratory which only performs laboratory examinations and procedures described in paragraph (3) shall be issued a certificate of waiver or have its certificate of waiver renewed if— (i) the laboratory submits an application— (I) in such form and manner as the Secretary shall prescribe, (II) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory, including the number and types of laboratory examinations and other procedures performed, the methodologies for laboratory examinations and other procedures employed, and the qualifications (educational background, training, and experience) of the personnel direct...

(a) Items or services specifically excluded Notwithstanding any other provision of this subchapter, no payment may be made under part A or part B for any expenses incurred for items or services— (1) (A) which, except for items and services described in a succeeding subparagraph, additional preventive services (as described in section 1395x(ddd)(1) of this title), or multi-cancer early detection screening tests (as defined in section 1395x(nnn) of this title), are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, (B) in the case of items and services described in section 1395x(s)(10) of this title, which are not reasonable and necessary for the prevention of illness, (C) in the case of hospice care, which are not reasonable and necessary for the palliation or management of terminal illness, (D) in the case of clinical care items and services provided with the concurrence of the Secretary and with respect to research and experimentation conducted by, or under contract with, the Medicare Payment Advisory Commission or the Secretary, which are not reasonable and necessary to carry out the purposes of section 1395ww(e)(6) of this title,1 (E) in the case of research conducted pursuant to section 1320b–12 of this title, which is not reasonable and necessary to carry out the purposes of that section, (F) in the case of screening mammography, which is performed more frequently than is covered under section 1395m(c)(2) of this title or which is not conducted by a facility described in section 1395m(c)(1)(B) of this title, in the case of screening pap smear and screening pelvic exam, which is performed more frequently than is provided under section 1395x(nn) of this title, and, in the case of screening for glaucoma, which is performed more frequently than is provided under section 1395x(uu) of this title, (G) in the case of prostate cancer screening tests (as defined in section 1395x(oo) of this title), which are performed more frequently than is covered under such section, (H) in the case of colorectal cancer screening tests, which are performed more frequently than is covered under section 1395m(d) of this title, (I) the frequency and duration of home health services which are in excess of normative guidelines that the Secretary shall establish by regulation, (J) in the case of a drug or biological specified in section 1395w–3a(c)(6)(C) of this title for which payment is made under part B that is furnished in a competitive area under section 1395w–3b of this title, that is not furnished by an entity under a contract under such section, (K) in the case of an initial preventive physical examination, which is performed more than 1 year after the date the individual’s first coverage period begins under part B, (L) in the case of cardiovascular screening blood tests (as defined in section 1395x(xx)(1) of this title), which are performed more frequently than is covered under section 1395x(xx)(2) of this title, (M) in the case of a diabetes screening test (as defined in section 1395x(yy)(1) of this title), which is performed more frequently than is covered under section 1395x(yy)(3) of this title, (N) in the case of ultrasound screening for abdominal aortic aneurysm which is performed more frequently than is provided for under section 1395x(s)(2)(AA) of this title, (O) in the case of kidney disease education services (as defined in paragraph (1) of section 1395x(ggg) of this title), which are furnished in excess of the number of sessions covered under paragraph (4) of such section, and (P) in the case of personalized prevention plan services (as defined in section 1395x(hhh)(1) of this title), which are performed more frequently than is covered under such section; (2) for which the individual furnished such items or services has no legal obligation to pay, and which no other person (by reason of such individual’s membership in a prepayment plan or othe...