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HHS/CMS | RIN: 0938-AR83 | Publication ID: Spring 2013 |
Title: ●Adverse Action for Proficiency Testing Referral Violations (CMS-3282-P) | |
Abstract: This proposed rule would establish adverse actions for proficiency testing referral violations and align enforcement actions with statutory changes that provide greater discretion. Enactment of the Taking Essential Steps for Testing Act of 2012 on December 4, 2012, amends the Public Health Services Act and provides greater discretion for the Secretary to substitute intermediate sanctions in lieu of the mandatory 2-year prohibition on the laboratory owner and operator when a CLIA certificate is revoked due to intentional PT referral, or to rely only on such intermediate sanctions and consider alternatives to mandatory revocation in such cases. This change has resulted in a conflict between the CLIA regulations and the statute. As currently written, the regulations offer no discretion and require CMS to revoke the laboratory's CLIA certification for at least 1 year and ban the owner and operator for 2 years when proficiency testing referral is confirmed. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 42 CFR 493 | |
Legal Authority: 42 USC 263a |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Melissa Singer Medical Technologist Department of Health and Human Services Centers for Medicare & Medicaid Services 7500 Security Boulevard, Baltimore, MD 21244 Phone:410 786-0365 Email: melissa.singer@cms.hhs.gov |