This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office] .
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
United States Code U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE
Title 42 published on 07-Jun-2018 03:52
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 493 after this date.
2018-01-09; vol. 83 # 6 - Tuesday, January 9, 2018 83 FR 1004 - Request for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services Request for information. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 12, 2018. 42 CFR Part 493 Summary This request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel requirements and histocompatibility requirements, which, with minor exception, have not been updated since 1992. We are also seeking public comment regarding the flexibility to impose alternative sanctions for laboratories issued a Certificate of Waiver (CoW) determined to have participated in proficiency testing (PT) referral. In addition, we are seeking public comment related to appropriate sanctions in situations where we determine that a laboratory has referred its PT samples to another laboratory and has reported the other laboratory's result as their own. This request for information also seeks public comment regarding the updating of fees for determination of program compliance and additional fees for laboratories established under the CLIA regulations. We are also seeking public comment regarding the collection of other fees we are authorized to collect such as fees for revised certificates, post survey follow-up visits, complaint investigations, and activities related to imposition of sanctions. We intend to consider public comments (including information such as evidence, research, and trends) received in response to this request for information when we draft proposals, in consultation, as appropriate, with the Centers for Disease Control and Prevention (CDC), to update the existing CLIA regulations through future rulemaking. We are also soliciting public comment on other areas of CLIA which should be reviewed and potentially updated.
2017-10-20; vol. 82 # 202 - Friday, October 20, 2017 82 FR 48770 - Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services Final rule. These regulations are effective December 19, 2017. 42 CFR Part 493 Summary This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.
2016-09-06; vol. 81 # 172 - Tuesday, September 6, 2016 81 FR 61538 - Adjustment of Civil Monetary Penalties for Inflation
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary, Centers for Medicare & Medicaid Services, Administration for Children and Families, Office of the Inspector General Interim final rule. This rule is effective on September 6, 2016. 42 CFR Part 3 Summary The Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations.
2014-11-07; vol. 79 # 216 - Friday, November 7, 2014 79 FR 66348 - Clinical Laboratory Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 6, 2015. 42 CFR Part 493 Summary This proposed rule would amend the Clinical Laboratory Improvement Amendments (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests. In addition, the proposed rule would remove the hemoglobin by copper sulfate method from the list of waived tests if commenters confirm that the method is no longer used.
2014-05-12; vol. 79 # 91 - Monday, May 12, 2014 79 FR 27106 - Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Part II
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services Final rule. These regulations are effective on July 11, 2014, with the exception of amendments to 42 CFR Part 483, which are effective May 12, 2014. 42 CFR Parts 413, 416, 440, 442, 482, 483, 485, 486, 488, 491, and 493 Summary This final rule reforms Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This final rule also increases the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert resources away from providing high quality patient care. We are issuing this rule to achieve regulatory reforms under Executive Order 13563 on improving regulation and regulatory review and the Department's plan for retrospective review of existing rules. This is the latest in a series of rules developed by CMS over the last 5 years to reform existing rules to reduce unnecessary costs and increase flexibility for health care providers.
2014-05-02; vol. 79 # 85 - Friday, May 2, 2014 79 FR 25436 - Medicare Program; Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services Final rule with comment period. Effective Dates: The provisions of this final rule with comment period are effective on October 1, 2014, except for amendments to § 405.2468(b)(1), § 491.8(a)(3), § 493.1, § 493.2, § 493.1800, and § 493.1840 which are effective July 1, 2014. Comment Period: We will consider comments on the subjects indicated in sections II.B.1., E.2. and E.4. of this final rule with comment period received at one of the addresses provided below, no later than 5 p.m. on July 1, 2014. 42 CFR Parts 405, 410, 491, and 493 Summary This final rule with comment period implements methodology and payment rates for a prospective payment system (PPS) for federally qualified health center (FQHC) services under Medicare Part B beginning on October 1, 2014, in compliance with the statutory requirement of the Affordable Care Act. In addition, it establishes a policy which allows rural health clinics (RHCs) to contract with nonphysician practitioners when statutory requirements for employment of nurse practitioners and physician assistants are met, and makes other technical and conforming changes to the RHC and FQHC regulations. Finally, this final rule with comment period implements changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing (PT) referrals.
2014-02-06; vol. 79 # 25 - Thursday, February 6, 2014 79 FR 7290 - CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary, Centers for Medicare & Medicaid Services Final rule. Effective Date: These regulations are effective on April 7, 2014. HIPAA covered entities must comply with the applicable requirements of this final rule by October 6, 2014. 42 CFR Part 493 Summary This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon the request of a patient (or the patient's personal representative), laboratories subject to CLIA may provide the patient, the patient's personal representative, or a person designated by the patient, as applicable, with copies of completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. Subject to conforming amendments, the final rule retains the existing provisions that require release of test reports only to authorized persons and, if applicable, to the persons responsible for using the test reports and to the laboratory that initially requested the test. In addition, this final rule amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals (or their personal representatives) with the right to access test reports directly from laboratories subject to HIPAA (and to direct that copies of those test reports be transmitted to persons or entities designated by the individual) by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information. These changes to the CLIA regulations and the HIPAA Privacy Rule provide individuals with a greater ability to access their health information, empowering them to take a more active role in managing their health and health care.
2013-09-23; vol. 78 # 184 - Monday, September 23, 2013 78 FR 58386 - Medicare Program; Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on November 18, 2013. 42 CFR Parts 405, 491, and 493 Summary This proposed rule would establish methodology and payment rates for a prospective payment system (PPS) for federally qualified health center (FQHC) services under Medicare Part B beginning on October 1, 2014, in compliance with the statutory requirement of the Affordable Care Act. This proposed rule would also establish a policy which would allow rural health clinics (RHCs) to contract with nonphysician practitioners when statutory requirements for employment of nurse practitioners and physician assistants are met, and make other technical and conforming changes to the RHC and FQHC regulations. Finally, this proposed rule would make changes to the Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing referral.
2013-02-07; vol. 78 # 26 - Thursday, February 7, 2013 78 FR 9216 - Medicare and Medicaid Programs; Part II—Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on April 8, 2013. 42 CFR Parts 416, 442, 482, 483, 485, 486, 488, 491, and 493 Summary This proposed rule would reform Medicare regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers, as well as certain regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This proposed rule would increase the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert resources away from providing high quality patient care. This is one of several rules that we are proposing to achieve regulatory reforms under Executive Order 13563 on improving regulation and regulatory review and the Department's plan for retrospective review of existing rules.
