45 CFR - Title 45—Public Welfare
Title 45 published on 2011-10-01
The following are only the Rules published in the Federal Register after the published date of Title 45.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24329 RIN 0938-AQ13 CMS-0040-CN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services Correction of final rule. Effective Date: November 5, 2012. 45 CFR Part 162 This document corrects technical errors in the final rule titled “Administrative Simplification: Adoption of a Standard for a Unique Health Plan Identifier; Addition to the National Provider Identifier Requirements; and a Change to the Compliance Date for the International Classification of Diseases, 10th Edition (ICD-10-CM and ICD-10-PCS) Medical Data Code Sets” that appeared in the September 5, 2012 Federal Register .
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-23893 RIN HEALTH AND HUMAN SERVICES DEPARTMENT, Administration for Children and Families 45 CFR Part 301
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-21238 RIN 0938-AQ13 CMS-0040-F DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services Final rule. Effective date: These regulations are effective on November 5, 2012. Compliance dates: Health plans with the exception of small health plans must obtain an HPID by November 5, 2014. Small health plans must obtain an HPID by November 5, 2015. Covered entities must use HPIDs in the standard transactions on or after November 7, 2016. An organization covered health care provider must comply with the implementation specifications in § 162.410(b) by May 6, 2013. 45 CFR Part 162 This final rule adopts the standard for a national unique health plan identifier (HPID) and establishes requirements for the implementation of the HPID. In addition, it adopts a data element that will serve as an other entity identifier (OEID), or an identifier for entities that are not health plans, health care providers, or individuals, but that need to be identified in standard transactions. This final rule also specifies the circumstances under which an organization covered health care provider must require certain noncovered individual health care providers who are prescribers to obtain and disclose a National Provider Identifier (NPI). Lastly, this final rule changes the compliance date for the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD-10-CM Guidelines for Coding and Reporting, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, including the Official ICD-10-PCS Guidelines for Coding and Reporting, from October 1, 2013 to October 1, 2014.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20982 RIN 0991-AB82 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Final rule. These regulations are effective October 4, 2012. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of October 4, 2012. 45 CFR Part 170 With this final rule, the Secretary of Health and Human Services adopts certification criteria that establish the technical capabilities and specify the related standards and implementation specifications that Certified Electronic Health Record (EHR) Technology will need to include to, at a minimum, support the achievement of meaningful use by eligible professionals, eligible hospitals, and critical access hospitals under the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in fiscal year and calendar year 2014. This final rule also makes changes to the permanent certification program for health information technology, including changing the program's name to the ONC HIT Certification Program.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-21519 RIN 0938-AQ70 CMS-9995-IFC2 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services (CMS) Amendment to interim final rule with request for comments. Effective date. These interim final regulations are effective on August 30, 2012. Comment date. Comments are due on or before October 29, 2012. Applicability date. This amendment to the interim final regulation generally applies to individuals on August 30, 2012. 45 CFR Part 152 This document contains an amendment regarding program eligibility to the interim final regulation implementing the Pre-Existing Condition Plan program under provisions of the Patient Protection and Affordable Care Act. In light of a new process recently announced by the Department of Homeland Security, eligibility for the program is being amended so that the program does not inadvertently expand the scope of that process.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20889 RIN Docket No. FDA-2011-N-0252 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary Direct final rule. This rule is effective January 10, 2013. Submit either electronic or written comments by November 13, 2012. If HHS/FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. 21 CFR Part 21 The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, “FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.” HHS/FDA is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations. HHS/FDA is issuing a direct final rule for this action because the Agency expects that there will be no significant adverse comment on this rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20889 RIN Docket No. FDA-2011-N-0252 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary Direct final rule. This rule is effective January 10, 2013. Submit either electronic or written comments by November 13, 2012. If HHS/FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. 21 CFR Part 21 The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, “FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.” HHS/FDA is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations. HHS/FDA is issuing a direct final rule for this action because the Agency expects that there will be no significant adverse comment on this rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20886 RIN Docket No. NIH-2011-0001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Direct Final rule. This rule is effective January 10, 2013. Submit either electronic or written comments by November 13, 2012. If HHS/NIH receives no significant adverse comments within the specified comment period, the agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. 45 CFR Part 5b The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is implementing a new system of records, 09-25-0223, “NIH Records Related to Research Misconduct Proceedings, HHS/NIH.” HHS is exempting this system of records from certain provisions of the Privacy Act to protect the integrity of NIH research misconduct proceedings and to protect the identity of confidential sources in such proceedings. HHS is issuing a direct final rule for this action because the agency expects that there will be no significant adverse comment on this rule. Elsewhere in this issue of the Federal Register , HHS is publishing a companion proposed rule under the agency's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives any significant comments and withdraws this direct final rule. The companion proposed rule and this direct final rule are substantively identical.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19557 RIN 0938-AR01 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Interim final rule with comment period. Effective Date: These regulations are effective on August 10, 2012. The incorporation by reference of the publications listed in this interim final rule with comment period is approved by the Director of the Office of the Federal Register August 10, 2012. Compliance Date: The compliance date for operating rules for the health care electronic funds transfers (EFT) and remittance advice transaction is January 1, 2014. Comment Date: To be assured consideration, comments must be received at one of the addresses provided in the ADDRESSES section of this interim final rule with comment period on or before October 9, 2012. 45 CFR Part 162 This interim final rule with comment period implements parts of section 1104 of the Affordable Care Act which requires the adoption of operating rules for the health care electronic funds transfers (EFT) and remittance advice transaction.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-17831 RIN 0938-AR36 CMS-9965-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule. Effective Date: These regulations are effective on August 20, 2012. 45 CFR Part 156 This final rule establishes data collection standards necessary to implement aspects of section 1302 of the Patient Protection and Affordable Care Act (Affordable Care Act), which directs the Secretary of Health and Human Services to define essential health benefits. This final rule outlines the data on applicable plans to be collected from certain issuers to support the definition of essential health benefits. This final rule also establishes a process for the recognition of accrediting entities for purposes of certification of qualified health plans.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12914 RIN 0938-AQ67 CMS-9989-CN DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule; correction. Effective Date: These corrections are effective on May 29, 2012. 45 CFR Parts 155, 156, and 157 This document corrects technical and typographical errors that appeared in the final rule, interim final rule, published in the Federal Register on March 27, 2012, entitled “Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12914 RIN 0938-AQ67 CMS-9989-CN DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule; correction. Effective Date: These corrections are effective on May 29, 2012. 45 CFR Parts 155, 156, and 157 This document corrects technical and typographical errors that appeared in the final rule, interim final rule, published in the Federal Register on March 27, 2012, entitled “Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12914 RIN 0938-AQ67 CMS-9989-CN DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule; correction. Effective Date: These corrections are effective on May 29, 2012. 45 CFR Parts 155, 156, and 157 This document corrects technical and typographical errors that appeared in the final rule, interim final rule, published in the Federal Register on March 27, 2012, entitled “Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11994 RIN 0938-AR07 CMS-9975-CN DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule; correction. Effective Date: This correction is effective on May 22, 2012. 45 CFR Part 153 This document corrects a technical error that appeared in the final rule with comment period published in the Federal Register on March 23, 2012 entitled, “Patient Protection and Affordable Care Act; Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11773 RIN CMS-9998-IFC3 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Center for Medicare and Medicaid Services (CMS) Interim final rule; correcting amendment. Effective date: This document is effective on May 16, 2012. Applicability date: The corrections are applicable on January 1, 2011. 45 CFR Part 158 This document corrects technical errors that appeared in the interim final rule published in the Federal Register on December 1, 2010, entitled “Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements under the Patient Protection and Affordable Care Act” and in the correction notice published in the Federal Register on December 30, 2010, entitled “Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Corrections to the Medical Loss Ratio Interim Final Rule With Request for Comments.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11753 RIN 0938-AR41 CMS-9998-F DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Final rule. Effective date. This rule is effective on June 15, 2012. Applicability date. The amendments to part 158 generally apply beginning July 1, 2012, to health insurance issuers offering group or individual health insurance coverage. 45 CFR Part 158 This final rule amends the regulations implementing medical loss ratio (MLR) standards for health insurance issuers under the Public Health Service Act in order to establish notice requirements for issuers in the group and individual markets that meet or exceed the applicable MLR standard in the 2011 MLR reporting year.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6125 RIN 0938-AQ67 CMS-9989-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule, Interim final rule. Effective Date: These regulations are effective on May 29, 2012. Comment Date: Certain provisions of this final rule are being issued as interim final. We will consider comments from the public on the following provisions: §§ 155.220(a)(3); 155.300(b); 155.302; 155.305(g); 155.310(e); 155.315(g); 155.340(d); 155.345(a); and, 155.345(g). To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time (EST) on May 11, 2012. 45 CFR Parts 155, 156, and 157 This final rule will implement the new Affordable Insurance Exchanges (“Exchanges”), consistent with title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6125 RIN 0938-AQ67 CMS-9989-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule, Interim final rule. Effective Date: These regulations are effective on May 29, 2012. Comment Date: Certain provisions of this final rule are being issued as interim final. We will consider comments from the public on the following provisions: §§ 155.220(a)(3); 155.300(b); 155.302; 155.305(g); 155.310(e); 155.315(g); 155.340(d); 155.345(a); and, 155.345(g). To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time (EST) on May 11, 2012. 45 CFR Parts 155, 156, and 157 This final rule will implement the new Affordable Insurance Exchanges (“Exchanges”), consistent with title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6125 RIN 0938-AQ67 CMS-9989-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule, Interim final rule. Effective Date: These regulations are effective on May 29, 2012. Comment Date: Certain provisions of this final rule are being issued as interim final. We will consider comments from the public on the following provisions: §§ 155.220(a)(3); 155.300(b); 155.302; 155.305(g); 155.310(e); 155.315(g); 155.340(d); 155.345(a); and, 155.345(g). To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time (EST) on May 11, 2012. 45 CFR Parts 155, 156, and 157 This final rule will implement the new Affordable Insurance Exchanges (“Exchanges”), consistent with title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6594 RIN 0938-AR07 CMS-9975-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule. Effective Date: These regulations are effective on May 22, 2012. 45 CFR Part 153 This final rule implements standards for States related to reinsurance and risk adjustment, and for health insurance issuers related to reinsurance, risk corridors, and risk adjustment consistent with title I of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. These programs will mitigate the impact of potential adverse selection and stabilize premiums in the individual and small group markets as insurance reforms and the Affordable Insurance Exchanges (“Exchanges”) are implemented, starting in 2014. The transitional State-based reinsurance program serves to reduce uncertainty by sharing risk in the individual market through making payments for high claims costs for enrollees. The temporary Federally administered risk corridors program serves to protect against uncertainty in rate setting by qualified health plans sharing risk in losses and gains with the Federal government. The permanent State-based risk adjustment program provides payments to health insurance issuers that disproportionately attract high-risk populations (such as individuals with chronic conditions).
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6359 RIN 0938-AQ95 DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Final rule. Effective Date. This rule is effective on April 20, 2012. Applicability Dates. The amendment to 45 CFR Part 147 applies to student health insurance coverage for policy years beginning on or after July 1, 2012. The amendments to 45 CFR Part 158 apply beginning January 1, 2013, to health insurance issuers offering student health insurance coverage. 45 CFR Parts 144, 147, and 158 This final rule establishes requirements for student health insurance coverage under the Public Health Service (PHS) Act and the Patient Protection and Affordable Care Act (Affordable Care Act). The final rule defines “student health insurance coverage” as a type of individual health insurance coverage, and specifies that certain PHS Act requirements are inapplicable to this type of individual health insurance coverage. This final rule also amends the medical loss ratio and annual limits requirements for student health insurance coverage under the PHS Act.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6359 RIN 0938-AQ95 DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Final rule. Effective Date. This rule is effective on April 20, 2012. Applicability Dates. The amendment to 45 CFR Part 147 applies to student health insurance coverage for policy years beginning on or after July 1, 2012. The amendments to 45 CFR Part 158 apply beginning January 1, 2013, to health insurance issuers offering student health insurance coverage. 45 CFR Parts 144, 147, and 158 This final rule establishes requirements for student health insurance coverage under the Public Health Service (PHS) Act and the Patient Protection and Affordable Care Act (Affordable Care Act). The final rule defines “student health insurance coverage” as a type of individual health insurance coverage, and specifies that certain PHS Act requirements are inapplicable to this type of individual health insurance coverage. This final rule also amends the medical loss ratio and annual limits requirements for student health insurance coverage under the PHS Act.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6359 RIN 0938-AQ95 DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Final rule. Effective Date. This rule is effective on April 20, 2012. Applicability Dates. The amendment to 45 CFR Part 147 applies to student health insurance coverage for policy years beginning on or after July 1, 2012. The amendments to 45 CFR Part 158 apply beginning January 1, 2013, to health insurance issuers offering student health insurance coverage. 45 CFR Parts 144, 147, and 158 This final rule establishes requirements for student health insurance coverage under the Public Health Service (PHS) Act and the Patient Protection and Affordable Care Act (Affordable Care Act). The final rule defines “student health insurance coverage” as a type of individual health insurance coverage, and specifies that certain PHS Act requirements are inapplicable to this type of individual health insurance coverage. This final rule also amends the medical loss ratio and annual limits requirements for student health insurance coverage under the PHS Act.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-4395 RIN 1505-AC30 CMS-9987-F DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF THE TREASURY, Centers for Medicare & Medicaid Services (CMS) Final rule. These regulations are effective on April 27, 2012. 31 CFR Part 33 This final rule sets forth a procedural framework for submission and review of initial applications for a Waiver for State Innovation described in section 1332 of the Patient Protection and the Affordable Care Act including processes to ensure opportunities for public input in the development of such applications by States and in the Federal review of the applications.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-3228 RIN 1545-BJ94 TD 9575 CMS-9982-F DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, DEPARTMENT OF THE TREASURY, Internal Revenue Service, Employee Benefits Security Administration Final rule. Effective date. These final regulations are effective April 16, 2012. Applicability date. The requirements to provide an SBC, notice of modification, and uniform glossary under PHS Act section 2715 and these final regulations apply for disclosures to participants and beneficiaries who enroll or re-enroll in group health coverage through an open enrollment period (including re-enrollees and late enrollees) beginning on the first day of the first open enrollment period that begins on or after September 23, 2012. For disclosures to participants and beneficiaries who enroll in group health plan coverage other than through an open enrollment period (including individuals who are newly eligible for coverage and special enrollees), the requirements under PHS Act section 2715 and these final regulations apply beginning on the first day of the first plan year that begins on or after September 23, 2012. For disclosures to plans, and to individuals and dependents in the individual market, these requirements are applicable to health insurance issuers beginning on September 23, 2012. 26 CFR Parts 54 and 602 This document contains final regulations regarding the summary of benefits and coverage and the uniform glossary for group health plans and health insurance coverage in the group and individual markets under the Patient Protection and Affordable Care Act. This document implements the disclosure requirements under section 2715 of the Public Health Service Act to help plans and individuals better understand their health coverage, as well as other coverage options. A guidance document published elsewhere in this issue of the Federal Register provides further guidance regarding compliance.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-3230 RIN CMS-9982-FN DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, DEPARTMENT OF THE TREASURY, Internal Revenue Service, Employee Benefits Security Administration Guidance for compliance and notice of availability of templates, instructions, and related materials. 26 CFR Part 54 The Departments of Health and Human Services, Labor, and the Treasury are simultaneously publishing in the Federal Register this guidance document and final regulations under the Patient Protection and Affordable Care Act to implement the disclosure for group health plans and health insurance issuers of the summary of benefits and coverage (SBC), notice of modifications, and the uniform glossary. This guidance document provides guidance for compliance with section 2715 of the Public Health Service Act and the Departments' final regulations, including a template for the SBC, instructions, sample language, a guide for coverage example calculations, and the uniform glossary.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-1392 RIN NATIONAL SCIENCE FOUNDATION Final rule. Effective February 3, 2012. 45 CFR Part 670 Pursuant to the Antarctic Conservation Act of 1978, The National Science Foundation (NSF) is amending its regulations to reflect newly designated Antarctic Specially Protected Areas (ASPA), Antarctic Specially Managed Areas (ASMA) and Historical Sites or Monuments (HSM). These additions reflect measures already adopted by the Antarctic Treaty Parties at recent Antarctic Treaty Consultative Meetings (ATCM). Finally, the regulation is being revised to correct some typographical and numbering errors.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-2098 RIN LEGAL SERVICES CORPORATION Final rule. Effective Date: This rule is effective February 1, 2012. 45 CFR Part 1611 The Legal Services Corporation (“Corporation”) is required by law to establish maximum income levels for individuals eligible for legal assistance. This document updates the specified income levels to reflect the annual amendments to the Federal Poverty Guidelines as issued by the Department of Health and Human Services.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-132 RIN 0938-AQ11 CMS-0024-IFC DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Interim final rule with comment period. Effective Date: These regulations are effective on January 10, 2012. The incorporation by reference of the publications listed in this interim final rule with comment period is approved by the Director of the Office of the Federal Register January 10, 2012. Compliance Date: The compliance date for this regulation is January 1, 2014. Comment Date: To be assured consideration, comments must be received at one of the addresses provided below on or before March 12, 2012. 45 CFR Parts 160 and 162 This interim final rule with comment period implements parts of section 1104 of the Affordable Care Act which requires the adoption of a standard for electronic funds transfers (EFT). It defines EFT and explains how the adopted standards support and facilitate health care EFT transmissions.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-132 RIN 0938-AQ11 CMS-0024-IFC DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Interim final rule with comment period. Effective Date: These regulations are effective on January 10, 2012. The incorporation by reference of the publications listed in this interim final rule with comment period is approved by the Director of the Office of the Federal Register January 10, 2012. Compliance Date: The compliance date for this regulation is January 1, 2014. Comment Date: To be assured consideration, comments must be received at one of the addresses provided below on or before March 12, 2012. 45 CFR Parts 160 and 162 This interim final rule with comment period implements parts of section 1104 of the Affordable Care Act which requires the adoption of a standard for electronic funds transfers (EFT). It defines EFT and explains how the adopted standards support and facilitate health care EFT transmissions.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-32911 RIN 0970-AC41 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Administration for Children and Families Interim final rule. This rule is effective February 6, 2012. Consideration will be given to all comments received by March 6, 2012. 45 CFR Parts 1355 and 1356 The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E benefits or medical assistance under title XIX of the Act (Medicaid) and such services or payments; in-kind expenditures from third-party sources for the Tribal share of administration and training expenditures under title IV-E; and other provisions to carry out the Tribal-related amendments to title IV-E. This interim final rule includes these provisions and technical amendments necessary to implement a Tribal title IV-E program.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-32911 RIN 0970-AC41 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Administration for Children and Families Interim final rule. This rule is effective February 6, 2012. Consideration will be given to all comments received by March 6, 2012. 45 CFR Parts 1355 and 1356 The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E benefits or medical assistance under title XIX of the Act (Medicaid) and such services or payments; in-kind expenditures from third-party sources for the Tribal share of administration and training expenditures under title IV-E; and other provisions to carry out the Tribal-related amendments to title IV-E. This interim final rule includes these provisions and technical amendments necessary to implement a Tribal title IV-E program.
Title 45 published on 2011-10-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to Title 45 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28428 RIN 0938-AR40 CMS-9972-P DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 26, 2012. 45 CFR Parts 144, 147, 150, 154 and 156 This proposed rule would implement the Affordable Care Act's policies related to fair health insurance premiums, guaranteed availability, guaranteed renewability, risk pools, and catastrophic plans. The proposed rule would clarify the approach used to enforce the applicable requirements of the Affordable Care Act with respect to health insurance issuers and group health plans that are non-federal governmental plans. This proposed rule would also amend the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under section 2794 of the Public Health Service Act (PHS Act). It also revises the timeline for states to propose state-specific thresholds for review and approval by CMS.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28428 RIN 0938-AR40 CMS-9972-P DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 26, 2012. 45 CFR Parts 144, 147, 150, 154 and 156 This proposed rule would implement the Affordable Care Act's policies related to fair health insurance premiums, guaranteed availability, guaranteed renewability, risk pools, and catastrophic plans. The proposed rule would clarify the approach used to enforce the applicable requirements of the Affordable Care Act with respect to health insurance issuers and group health plans that are non-federal governmental plans. This proposed rule would also amend the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under section 2794 of the Public Health Service Act (PHS Act). It also revises the timeline for states to propose state-specific thresholds for review and approval by CMS.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28428 RIN 0938-AR40 CMS-9972-P DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 26, 2012. 45 CFR Parts 144, 147, 150, 154 and 156 This proposed rule would implement the Affordable Care Act's policies related to fair health insurance premiums, guaranteed availability, guaranteed renewability, risk pools, and catastrophic plans. The proposed rule would clarify the approach used to enforce the applicable requirements of the Affordable Care Act with respect to health insurance issuers and group health plans that are non-federal governmental plans. This proposed rule would also amend the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under section 2794 of the Public Health Service Act (PHS Act). It also revises the timeline for states to propose state-specific thresholds for review and approval by CMS.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28428 RIN 0938-AR40 CMS-9972-P DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 26, 2012. 45 CFR Parts 144, 147, 150, 154 and 156 This proposed rule would implement the Affordable Care Act's policies related to fair health insurance premiums, guaranteed availability, guaranteed renewability, risk pools, and catastrophic plans. The proposed rule would clarify the approach used to enforce the applicable requirements of the Affordable Care Act with respect to health insurance issuers and group health plans that are non-federal governmental plans. This proposed rule would also amend the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under section 2794 of the Public Health Service Act (PHS Act). It also revises the timeline for states to propose state-specific thresholds for review and approval by CMS.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28428 RIN 0938-AR40 CMS-9972-P DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 26, 2012. 45 CFR Parts 144, 147, 150, 154 and 156 This proposed rule would implement the Affordable Care Act's policies related to fair health insurance premiums, guaranteed availability, guaranteed renewability, risk pools, and catastrophic plans. The proposed rule would clarify the approach used to enforce the applicable requirements of the Affordable Care Act with respect to health insurance issuers and group health plans that are non-federal governmental plans. This proposed rule would also amend the standards for health insurance issuers and states regarding reporting, utilization, and collection of data under section 2794 of the Public Health Service Act (PHS Act). It also revises the timeline for states to propose state-specific thresholds for review and approval by CMS.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28361 RIN 1545-BL07 REG-122707-12 CMS-9979-P DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, DEPARTMENT OF THE TREASURY, Internal Revenue Service, Employee Benefits Security Administration Notice of proposed rulemaking. Comments are due on or before January 25, 2013. 26 CFR Part 54 This document proposes amendments to regulations, consistent with the Affordable Care Act, regarding nondiscriminatory wellness programs in group health coverage. Specifically, these proposed regulations would increase the maximum permissible reward under a health-contingent wellness program offered in connection with a group health plan (and any related health insurance coverage) from 20 percent to 30 percent of the cost of coverage. The proposed regulations would further increase the maximum permissible reward to 50 percent for wellness programs designed to prevent or reduce tobacco use. These regulations also include other proposed clarifications regarding the reasonable design of health-contingent wellness programs and the reasonable alternatives they must offer in order to avoid prohibited discrimination.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28361 RIN 1545-BL07 REG-122707-12 CMS-9979-P DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, DEPARTMENT OF THE TREASURY, Internal Revenue Service, Employee Benefits Security Administration Notice of proposed rulemaking. Comments are due on or before January 25, 2013. 26 CFR Part 54 This document proposes amendments to regulations, consistent with the Affordable Care Act, regarding nondiscriminatory wellness programs in group health coverage. Specifically, these proposed regulations would increase the maximum permissible reward under a health-contingent wellness program offered in connection with a group health plan (and any related health insurance coverage) from 20 percent to 30 percent of the cost of coverage. The proposed regulations would further increase the maximum permissible reward to 50 percent for wellness programs designed to prevent or reduce tobacco use. These regulations also include other proposed clarifications regarding the reasonable design of health-contingent wellness programs and the reasonable alternatives they must offer in order to avoid prohibited discrimination.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28362 RIN 0938-AR03 CMS-9980-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time (EST) on December 26, 2012. 45 CFR Parts 147, 155, and 156 This proposed rule details standards for health insurance issuers consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. Specifically, this proposed rule outlines Exchange and issuer standards related to coverage of essential health benefits and actuarial value. This proposed rule also proposes a timeline for qualified health plans to be accredited in Federally-facilitated Exchanges and an amendment which provides an application process for the recognition of additional accrediting entities for purposes of certification of qualified health plans.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28362 RIN 0938-AR03 CMS-9980-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time (EST) on December 26, 2012. 45 CFR Parts 147, 155, and 156 This proposed rule details standards for health insurance issuers consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. Specifically, this proposed rule outlines Exchange and issuer standards related to coverage of essential health benefits and actuarial value. This proposed rule also proposes a timeline for qualified health plans to be accredited in Federally-facilitated Exchanges and an amendment which provides an application process for the recognition of additional accrediting entities for purposes of certification of qualified health plans.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-28362 RIN 0938-AR03 CMS-9980-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time (EST) on December 26, 2012. 45 CFR Parts 147, 155, and 156 This proposed rule details standards for health insurance issuers consistent with title I of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. Specifically, this proposed rule outlines Exchange and issuer standards related to coverage of essential health benefits and actuarial value. This proposed rule also proposes a timeline for qualified health plans to be accredited in Federally-facilitated Exchanges and an amendment which provides an application process for the recognition of additional accrediting entities for purposes of certification of qualified health plans.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24467 RIN 3045-AA56 CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Final rule. This final rule is effective January 1, 2013. 45 CFR Parts 2510, 2522, 2540, 2551, and 2552 To implement the Serve America Act, the Corporation for National and Community Service (CNCS) proposed amendments to its National Service Criminal History Check regulation on July 6, 2011. This final rule adopts the proposed amendments, clarifies several requirements, and makes minor technical corrections. The amendments require CNCS grantees to conduct and document a National Service Criminal History Check that includes a fingerprint-based FBI criminal history check on individuals in covered positions who begin work, or who start service, on or after April 21, 2011, and who have recurring access to children 17 years of age or younger, to persons age 60 and older, or to individuals with disabilities. Individuals in covered positions include Senior Companions (SCP), Foster Grandparents (FGP), AmeriCorps State and National participants, and other participants, volunteers, or staff funded under a CNCS grant.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24467 RIN 3045-AA56 CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Final rule. This final rule is effective January 1, 2013. 45 CFR Parts 2510, 2522, 2540, 2551, and 2552 To implement the Serve America Act, the Corporation for National and Community Service (CNCS) proposed amendments to its National Service Criminal History Check regulation on July 6, 2011. This final rule adopts the proposed amendments, clarifies several requirements, and makes minor technical corrections. The amendments require CNCS grantees to conduct and document a National Service Criminal History Check that includes a fingerprint-based FBI criminal history check on individuals in covered positions who begin work, or who start service, on or after April 21, 2011, and who have recurring access to children 17 years of age or younger, to persons age 60 and older, or to individuals with disabilities. Individuals in covered positions include Senior Companions (SCP), Foster Grandparents (FGP), AmeriCorps State and National participants, and other participants, volunteers, or staff funded under a CNCS grant.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24467 RIN 3045-AA56 CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Final rule. This final rule is effective January 1, 2013. 45 CFR Parts 2510, 2522, 2540, 2551, and 2552 To implement the Serve America Act, the Corporation for National and Community Service (CNCS) proposed amendments to its National Service Criminal History Check regulation on July 6, 2011. This final rule adopts the proposed amendments, clarifies several requirements, and makes minor technical corrections. The amendments require CNCS grantees to conduct and document a National Service Criminal History Check that includes a fingerprint-based FBI criminal history check on individuals in covered positions who begin work, or who start service, on or after April 21, 2011, and who have recurring access to children 17 years of age or younger, to persons age 60 and older, or to individuals with disabilities. Individuals in covered positions include Senior Companions (SCP), Foster Grandparents (FGP), AmeriCorps State and National participants, and other participants, volunteers, or staff funded under a CNCS grant.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24467 RIN 3045-AA56 CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Final rule. This final rule is effective January 1, 2013. 45 CFR Parts 2510, 2522, 2540, 2551, and 2552 To implement the Serve America Act, the Corporation for National and Community Service (CNCS) proposed amendments to its National Service Criminal History Check regulation on July 6, 2011. This final rule adopts the proposed amendments, clarifies several requirements, and makes minor technical corrections. The amendments require CNCS grantees to conduct and document a National Service Criminal History Check that includes a fingerprint-based FBI criminal history check on individuals in covered positions who begin work, or who start service, on or after April 21, 2011, and who have recurring access to children 17 years of age or younger, to persons age 60 and older, or to individuals with disabilities. Individuals in covered positions include Senior Companions (SCP), Foster Grandparents (FGP), AmeriCorps State and National participants, and other participants, volunteers, or staff funded under a CNCS grant.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24467 RIN 3045-AA56 CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Final rule. This final rule is effective January 1, 2013. 45 CFR Parts 2510, 2522, 2540, 2551, and 2552 To implement the Serve America Act, the Corporation for National and Community Service (CNCS) proposed amendments to its National Service Criminal History Check regulation on July 6, 2011. This final rule adopts the proposed amendments, clarifies several requirements, and makes minor technical corrections. The amendments require CNCS grantees to conduct and document a National Service Criminal History Check that includes a fingerprint-based FBI criminal history check on individuals in covered positions who begin work, or who start service, on or after April 21, 2011, and who have recurring access to children 17 years of age or younger, to persons age 60 and older, or to individuals with disabilities. Individuals in covered positions include Senior Companions (SCP), Foster Grandparents (FGP), AmeriCorps State and National participants, and other participants, volunteers, or staff funded under a CNCS grant.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-24329 RIN 0938-AQ13 CMS-0040-CN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services Correction of final rule. Effective Date: November 5, 2012. 45 CFR Part 162 This document corrects technical errors in the final rule titled “Administrative Simplification: Adoption of a Standard for a Unique Health Plan Identifier; Addition to the National Provider Identifier Requirements; and a Change to the Compliance Date for the International Classification of Diseases, 10th Edition (ICD-10-CM and ICD-10-PCS) Medical Data Code Sets” that appeared in the September 5, 2012 Federal Register .
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-23893 RIN HEALTH AND HUMAN SERVICES DEPARTMENT, Administration for Children and Families 45 CFR Part 301
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-21238 RIN 0938-AQ13 CMS-0040-F DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services Final rule. Effective date: These regulations are effective on November 5, 2012. Compliance dates: Health plans with the exception of small health plans must obtain an HPID by November 5, 2014. Small health plans must obtain an HPID by November 5, 2015. Covered entities must use HPIDs in the standard transactions on or after November 7, 2016. An organization covered health care provider must comply with the implementation specifications in § 162.410(b) by May 6, 2013. 45 CFR Part 162 This final rule adopts the standard for a national unique health plan identifier (HPID) and establishes requirements for the implementation of the HPID. In addition, it adopts a data element that will serve as an other entity identifier (OEID), or an identifier for entities that are not health plans, health care providers, or individuals, but that need to be identified in standard transactions. This final rule also specifies the circumstances under which an organization covered health care provider must require certain noncovered individual health care providers who are prescribers to obtain and disclose a National Provider Identifier (NPI). Lastly, this final rule changes the compliance date for the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD-10-CM Guidelines for Coding and Reporting, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, including the Official ICD-10-PCS Guidelines for Coding and Reporting, from October 1, 2013 to October 1, 2014.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20982 RIN 0991-AB82 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Final rule. These regulations are effective October 4, 2012. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of October 4, 2012. 45 CFR Part 170 With this final rule, the Secretary of Health and Human Services adopts certification criteria that establish the technical capabilities and specify the related standards and implementation specifications that Certified Electronic Health Record (EHR) Technology will need to include to, at a minimum, support the achievement of meaningful use by eligible professionals, eligible hospitals, and critical access hospitals under the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in fiscal year and calendar year 2014. This final rule also makes changes to the permanent certification program for health information technology, including changing the program's name to the ONC HIT Certification Program.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-21519 RIN 0938-AQ70 CMS-9995-IFC2 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services (CMS) Amendment to interim final rule with request for comments. Effective date. These interim final regulations are effective on August 30, 2012. Comment date. Comments are due on or before October 29, 2012. Applicability date. This amendment to the interim final regulation generally applies to individuals on August 30, 2012. 45 CFR Part 152 This document contains an amendment regarding program eligibility to the interim final regulation implementing the Pre-Existing Condition Plan program under provisions of the Patient Protection and Affordable Care Act. In light of a new process recently announced by the Department of Homeland Security, eligibility for the program is being amended so that the program does not inadvertently expand the scope of that process.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20889 RIN Docket No. FDA-2011-N-0252 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary Direct final rule. This rule is effective January 10, 2013. Submit either electronic or written comments by November 13, 2012. If HHS/FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. 21 CFR Part 21 The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, “FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.” HHS/FDA is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations. HHS/FDA is issuing a direct final rule for this action because the Agency expects that there will be no significant adverse comment on this rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20889 RIN Docket No. FDA-2011-N-0252 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary Direct final rule. This rule is effective January 10, 2013. Submit either electronic or written comments by November 13, 2012. If HHS/FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. 21 CFR Part 21 The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, “FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.” HHS/FDA is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations. HHS/FDA is issuing a direct final rule for this action because the Agency expects that there will be no significant adverse comment on this rule.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20886 RIN Docket No. NIH-2011-0001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Direct Final rule. This rule is effective January 10, 2013. Submit either electronic or written comments by November 13, 2012. If HHS/NIH receives no significant adverse comments within the specified comment period, the agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. 45 CFR Part 5b The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is implementing a new system of records, 09-25-0223, “NIH Records Related to Research Misconduct Proceedings, HHS/NIH.” HHS is exempting this system of records from certain provisions of the Privacy Act to protect the integrity of NIH research misconduct proceedings and to protect the identity of confidential sources in such proceedings. HHS is issuing a direct final rule for this action because the agency expects that there will be no significant adverse comment on this rule. Elsewhere in this issue of the Federal Register , HHS is publishing a companion proposed rule under the agency's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives any significant comments and withdraws this direct final rule. The companion proposed rule and this direct final rule are substantively identical.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20890 RIN Docket No. FDA-2011-N-0252 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, Office of the Secretary Proposed rule. Submit either electronic or written comments by November 13, 2012. If HHS/FDA receives any significant adverse comments, the Agency will publish a document withdrawing the direct final rule within 30 days after the comment period ends. HHS/FDA will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures. 21 CFR Part 21 The Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) will be implementing a new system of records, 09-10-0020, “FDA Records Related to Research Misconduct Proceedings, HHS/FDA/OC.” HHS/FDA proposes to exempt this system of records from certain requirements of the Privacy Act to protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-20887 RIN Docket No. NIH-2011-0001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice of proposed rulemaking. Submit either electronic or written comments by November 13, 2012. If HHS/NIH receives any significant adverse comments, the agency will publish withdrawing the direct final rule within 30 days after the comment period ends. HHS/NIH will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures. 45 CFR Part 5b The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is implementing a new system of records, 09-25-0223, “NIH Records Related to Research Misconduct Proceedings, HHS/NIH.” HHS is exempting this system of records from certain requirements of the Privacy Act to protect the integrity of NIH research misconduct proceedings and to protect the identity of confidential sources in such proceedings. Elsewhere in this issue of the Federal Register , HHS is issuing a direct final rule for this action because the agency expects that there will be no significant adverse comment on this rule. HHS is publishing this companion proposed rule under the agency's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency publishing this companion proposed rule under the agency's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant comments and withdraws the direct final rule. The direct final rule and this companion proposed rule are substantively identical.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19557 RIN 0938-AR01 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Interim final rule with comment period. Effective Date: These regulations are effective on August 10, 2012. The incorporation by reference of the publications listed in this interim final rule with comment period is approved by the Director of the Office of the Federal Register August 10, 2012. Compliance Date: The compliance date for operating rules for the health care electronic funds transfers (EFT) and remittance advice transaction is January 1, 2014. Comment Date: To be assured consideration, comments must be received at one of the addresses provided in the ADDRESSES section of this interim final rule with comment period on or before October 9, 2012. 45 CFR Part 162 This interim final rule with comment period implements parts of section 1104 of the Affordable Care Act which requires the adoption of operating rules for the health care electronic funds transfers (EFT) and remittance advice transaction.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19073 RIN LEGAL SERVICES CORPORATION Further Notice of Proposed Rulemaking. Comments on the FNPRM are due September 6, 2012. 45 CFR Parts 1606, 1618, and 1623 This Further Notice of Proposed Rulemaking (FNPRM) proposes modifications to the January 31, 2012, NPRM regarding amendments to the Legal Services Corporation's regulations on termination procedures, enforcement, and suspension procedures. LSC seeks comments limited to the substantively new materials as indicated by the questions in the SUPPLEMENTARY INFORMATION .
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19073 RIN LEGAL SERVICES CORPORATION Further Notice of Proposed Rulemaking. Comments on the FNPRM are due September 6, 2012. 45 CFR Parts 1606, 1618, and 1623 This Further Notice of Proposed Rulemaking (FNPRM) proposes modifications to the January 31, 2012, NPRM regarding amendments to the Legal Services Corporation's regulations on termination procedures, enforcement, and suspension procedures. LSC seeks comments limited to the substantively new materials as indicated by the questions in the SUPPLEMENTARY INFORMATION .
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-19073 RIN LEGAL SERVICES CORPORATION Further Notice of Proposed Rulemaking. Comments on the FNPRM are due September 6, 2012. 45 CFR Parts 1606, 1618, and 1623 This Further Notice of Proposed Rulemaking (FNPRM) proposes modifications to the January 31, 2012, NPRM regarding amendments to the Legal Services Corporation's regulations on termination procedures, enforcement, and suspension procedures. LSC seeks comments limited to the substantively new materials as indicated by the questions in the SUPPLEMENTARY INFORMATION .
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-17831 RIN 0938-AR36 CMS-9965-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule. Effective Date: These regulations are effective on August 20, 2012. 45 CFR Part 156 This final rule establishes data collection standards necessary to implement aspects of section 1302 of the Patient Protection and Affordable Care Act (Affordable Care Act), which directs the Secretary of Health and Human Services to define essential health benefits. This final rule outlines the data on applicable plans to be collected from certain issuers to support the definition of essential health benefits. This final rule also establishes a process for the recognition of accrediting entities for purposes of certification of qualified health plans.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-13489 RIN 0938-AR36 CMS-9965-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Proposed rule. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time (EST) on July 5, 2012. 45 CFR Part 156 This proposed rule would establish data collection standards necessary to implement aspects of the Patient Protection and Affordable Care Act (Affordable Care Act), which directs the Secretary of Health and Human Services to define essential health benefits. This proposed rule outlines the data on applicable plans to be collected from certain issuers to support the definition of essential health benefits. A bulletin on HHS' intended benchmark approach to defining essential health benefits was published for comment on December 16, 2011, and we intend to pursue comprehensive rulemaking on essential health benefits in the future. This proposed rule would also establish a process for the recognition of accrediting entities for purposes of certification of qualified health plans.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12914 RIN 0938-AQ67 CMS-9989-CN DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule; correction. Effective Date: These corrections are effective on May 29, 2012. 45 CFR Parts 155, 156, and 157 This document corrects technical and typographical errors that appeared in the final rule, interim final rule, published in the Federal Register on March 27, 2012, entitled “Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12914 RIN 0938-AQ67 CMS-9989-CN DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule; correction. Effective Date: These corrections are effective on May 29, 2012. 45 CFR Parts 155, 156, and 157 This document corrects technical and typographical errors that appeared in the final rule, interim final rule, published in the Federal Register on March 27, 2012, entitled “Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-12914 RIN 0938-AQ67 CMS-9989-CN DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule; correction. Effective Date: These corrections are effective on May 29, 2012. 45 CFR Parts 155, 156, and 157 This document corrects technical and typographical errors that appeared in the final rule, interim final rule, published in the Federal Register on March 27, 2012, entitled “Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11994 RIN 0938-AR07 CMS-9975-CN DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule; correction. Effective Date: This correction is effective on May 22, 2012. 45 CFR Part 153 This document corrects a technical error that appeared in the final rule with comment period published in the Federal Register on March 23, 2012 entitled, “Patient Protection and Affordable Care Act; Standards Related to Reinsurance, Risk Corridors, and Risk Adjustment.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11773 RIN CMS-9998-IFC3 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Center for Medicare and Medicaid Services (CMS) Interim final rule; correcting amendment. Effective date: This document is effective on May 16, 2012. Applicability date: The corrections are applicable on January 1, 2011. 45 CFR Part 158 This document corrects technical errors that appeared in the interim final rule published in the Federal Register on December 1, 2010, entitled “Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements under the Patient Protection and Affordable Care Act” and in the correction notice published in the Federal Register on December 30, 2010, entitled “Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Corrections to the Medical Loss Ratio Interim Final Rule With Request for Comments.”
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11753 RIN 0938-AR41 CMS-9998-F DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Final rule. Effective date. This rule is effective on June 15, 2012. Applicability date. The amendments to part 158 generally apply beginning July 1, 2012, to health insurance issuers offering group or individual health insurance coverage. 45 CFR Part 158 This final rule amends the regulations implementing medical loss ratio (MLR) standards for health insurance issuers under the Public Health Service Act in order to establish notice requirements for issuers in the group and individual markets that meet or exceed the applicable MLR standard in the 2011 MLR reporting year.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-11775 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Request for information. To be assured consideration, written or electronic comments must be received at one of the addresses provided below, no later than 5 p.m. on June 14, 2012. 45 CFR Part 171 The nationwide health information network is defined as the set of standards, services, and policies that enable secure health information exchange over the Internet. Enacted in February 2009, the Health Information Technology for Economic and Clinical Health (HITECH) Act requires the National Coordinator for Health Information Technology to establish a governance mechanism for the nationwide health information network (section 3001(c)(8) of the Public Health Service Act (PHSA)). This request for information (RFI) is being issued to request public comment on draft proposals the Office of the National Coordinator for Health Information Technology (ONC) is considering in anticipation of developing a notice of proposed rulemaking (NPRM) to establish such a governance mechanism. This RFI seeks broad input on a range of topics, including: The creation of a voluntary program under which entities that facilitate electronic health information exchange could be validated with respect to their conformance to certain ONC-established “conditions for trusted exchange (CTEs);” the scope and requirements included in the initial CTEs; the processes that could be used to revise, adopt new, and retire CTEs, including but not limited to the standards development and adoption process provided in section 3004 and other relevant sections of the PHSA; and a process to classify the readiness for nationwide adoption and use of technical standards and implementation specifications to support interoperability related CTEs.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-9260 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Administration for Children and Families Request for public comment. Written comments must be submitted to the office listed in the ADDRESSES section below on or before June 11, 2012. 45 CFR Parts 262 and 265 The Office of Family Assistance (OFA) is interested in learning about how States deliver Temporary Assistance to Needy Families (TANF) assistance to beneficiaries, whether States have implemented policies and practices to prevent electronic benefit transfer transactions involving TANF assistance in liquor stores, casinos, gambling casinos, or other gaming establishments, and retail establishments which provide adult-oriented entertainment in which performers disrobe or perform in an unclothed state for entertainment; what the States' experiences have been in implementing such policies and practices; and whether States place other similar types of restrictions on assistance usage. OFA also is interested in learning about States' current approaches to ensuring that recipients have adequate access to their cash assistance, including policies that provide access to assistance with no fees or charges or current approaches to imposing fees or charges in connection with receipt of assistance, along with other information relevant to considering what might be minimal fees or charges. Additionally, OFA is interested in hearing the perspectives of vendors, consumer advocates, and any other individuals or entities that have information that could be relevant to the development and implementation of policies and procedures to prevent electronic benefit transfer transactions in certain establishments, and to ensuring access to cash assistance with minimal fees or charges, including opportunities to access assistance without fees or charges. The information provided will be used to inform OFA as it develops regulations to implement Section 4004 of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96), which, among other things, requires States to prevent the use of TANF assistance in electronic benefit transfer transactions at specified locations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-9260 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Administration for Children and Families Request for public comment. Written comments must be submitted to the office listed in the ADDRESSES section below on or before June 11, 2012. 45 CFR Parts 262 and 265 The Office of Family Assistance (OFA) is interested in learning about how States deliver Temporary Assistance to Needy Families (TANF) assistance to beneficiaries, whether States have implemented policies and practices to prevent electronic benefit transfer transactions involving TANF assistance in liquor stores, casinos, gambling casinos, or other gaming establishments, and retail establishments which provide adult-oriented entertainment in which performers disrobe or perform in an unclothed state for entertainment; what the States' experiences have been in implementing such policies and practices; and whether States place other similar types of restrictions on assistance usage. OFA also is interested in learning about States' current approaches to ensuring that recipients have adequate access to their cash assistance, including policies that provide access to assistance with no fees or charges or current approaches to imposing fees or charges in connection with receipt of assistance, along with other information relevant to considering what might be minimal fees or charges. Additionally, OFA is interested in hearing the perspectives of vendors, consumer advocates, and any other individuals or entities that have information that could be relevant to the development and implementation of policies and procedures to prevent electronic benefit transfer transactions in certain establishments, and to ensuring access to cash assistance with minimal fees or charges, including opportunities to access assistance without fees or charges. The information provided will be used to inform OFA as it develops regulations to implement Section 4004 of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96), which, among other things, requires States to prevent the use of TANF assistance in electronic benefit transfer transactions at specified locations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-8718 RIN 0938-AQ13 CMS-0040-P DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Proposed rule. Comment Date: To be assured consideration, comments must be received at one of the addresses provided, no later than 5 p.m. on May 17, 2012. 45 CFR Part 162 This proposed rule would implement section 1104 of the Patient Protection and Affordable Care Act (hereinafter referred to as the Affordable Care Act) by establishing new requirements for administrative transactions that would improve the utility of the existing Health Insurance Portability and Accountability Act of 1996 (HIPAA) transactions and reduce administrative burden and costs. It proposes the adoption of the standard for a national unique health plan identifier (HPID) and requirements or provisions for the implementation of the HPID. This rule also proposes the adoption of a data element that will serve as an other entity identifier (OEID), an identifier for entities that are not health plans, health care providers, or “individuals,” that need to be identified in standard transactions. This proposed rule would also specify the circumstances under which an organization covered health care provider must require certain noncovered individual health care providers who are prescribers to obtain and disclose an NPI. Finally, this rule proposes to change the compliance date for the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD-10-CM Guidelines for Coding and Reporting, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, including the Official ICD-10-PCS Guidelines for Coding and Reporting, from October 1, 2013 to October 1, 2014.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6125 RIN 0938-AQ67 CMS-9989-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule, Interim final rule. Effective Date: These regulations are effective on May 29, 2012. Comment Date: Certain provisions of this final rule are being issued as interim final. We will consider comments from the public on the following provisions: §§ 155.220(a)(3); 155.300(b); 155.302; 155.305(g); 155.310(e); 155.315(g); 155.340(d); 155.345(a); and, 155.345(g). To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time (EST) on May 11, 2012. 45 CFR Parts 155, 156, and 157 This final rule will implement the new Affordable Insurance Exchanges (“Exchanges”), consistent with title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6125 RIN 0938-AQ67 CMS-9989-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule, Interim final rule. Effective Date: These regulations are effective on May 29, 2012. Comment Date: Certain provisions of this final rule are being issued as interim final. We will consider comments from the public on the following provisions: §§ 155.220(a)(3); 155.300(b); 155.302; 155.305(g); 155.310(e); 155.315(g); 155.340(d); 155.345(a); and, 155.345(g). To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time (EST) on May 11, 2012. 45 CFR Parts 155, 156, and 157 This final rule will implement the new Affordable Insurance Exchanges (“Exchanges”), consistent with title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6125 RIN 0938-AQ67 CMS-9989-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule, Interim final rule. Effective Date: These regulations are effective on May 29, 2012. Comment Date: Certain provisions of this final rule are being issued as interim final. We will consider comments from the public on the following provisions: §§ 155.220(a)(3); 155.300(b); 155.302; 155.305(g); 155.310(e); 155.315(g); 155.340(d); 155.345(a); and, 155.345(g). To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. Eastern Standard Time (EST) on May 11, 2012. 45 CFR Parts 155, 156, and 157 This final rule will implement the new Affordable Insurance Exchanges (“Exchanges”), consistent with title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The Exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The Exchanges, which will become operational by January 1, 2014, will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6594 RIN 0938-AR07 CMS-9975-F DEPARTMENT OF HEALTH AND HUMAN SERVICES Final rule. Effective Date: These regulations are effective on May 22, 2012. 45 CFR Part 153 This final rule implements standards for States related to reinsurance and risk adjustment, and for health insurance issuers related to reinsurance, risk corridors, and risk adjustment consistent with title I of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. These programs will mitigate the impact of potential adverse selection and stabilize premiums in the individual and small group markets as insurance reforms and the Affordable Insurance Exchanges (“Exchanges”) are implemented, starting in 2014. The transitional State-based reinsurance program serves to reduce uncertainty by sharing risk in the individual market through making payments for high claims costs for enrollees. The temporary Federally administered risk corridors program serves to protect against uncertainty in rate setting by qualified health plans sharing risk in losses and gains with the Federal government. The permanent State-based risk adjustment program provides payments to health insurance issuers that disproportionately attract high-risk populations (such as individuals with chronic conditions).
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6359 RIN 0938-AQ95 DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Final rule. Effective Date. This rule is effective on April 20, 2012. Applicability Dates. The amendment to 45 CFR Part 147 applies to student health insurance coverage for policy years beginning on or after July 1, 2012. The amendments to 45 CFR Part 158 apply beginning January 1, 2013, to health insurance issuers offering student health insurance coverage. 45 CFR Parts 144, 147, and 158 This final rule establishes requirements for student health insurance coverage under the Public Health Service (PHS) Act and the Patient Protection and Affordable Care Act (Affordable Care Act). The final rule defines “student health insurance coverage” as a type of individual health insurance coverage, and specifies that certain PHS Act requirements are inapplicable to this type of individual health insurance coverage. This final rule also amends the medical loss ratio and annual limits requirements for student health insurance coverage under the PHS Act.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6359 RIN 0938-AQ95 DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Final rule. Effective Date. This rule is effective on April 20, 2012. Applicability Dates. The amendment to 45 CFR Part 147 applies to student health insurance coverage for policy years beginning on or after July 1, 2012. The amendments to 45 CFR Part 158 apply beginning January 1, 2013, to health insurance issuers offering student health insurance coverage. 45 CFR Parts 144, 147, and 158 This final rule establishes requirements for student health insurance coverage under the Public Health Service (PHS) Act and the Patient Protection and Affordable Care Act (Affordable Care Act). The final rule defines “student health insurance coverage” as a type of individual health insurance coverage, and specifies that certain PHS Act requirements are inapplicable to this type of individual health insurance coverage. This final rule also amends the medical loss ratio and annual limits requirements for student health insurance coverage under the PHS Act.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6359 RIN 0938-AQ95 DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Centers for Medicare & Medicaid Services (CMS) Final rule. Effective Date. This rule is effective on April 20, 2012. Applicability Dates. The amendment to 45 CFR Part 147 applies to student health insurance coverage for policy years beginning on or after July 1, 2012. The amendments to 45 CFR Part 158 apply beginning January 1, 2013, to health insurance issuers offering student health insurance coverage. 45 CFR Parts 144, 147, and 158 This final rule establishes requirements for student health insurance coverage under the Public Health Service (PHS) Act and the Patient Protection and Affordable Care Act (Affordable Care Act). The final rule defines “student health insurance coverage” as a type of individual health insurance coverage, and specifies that certain PHS Act requirements are inapplicable to this type of individual health insurance coverage. This final rule also amends the medical loss ratio and annual limits requirements for student health insurance coverage under the PHS Act.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-6689 RIN 1545-BJ60 CMS-9968-ANPRM DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, DEPARTMENT OF THE TREASURY, Internal Revenue Service, Employee Benefits Security Administration Advance notice of proposed rulemaking (ANPRM). Comments are due on or before June 19, 2012. 26 CFR Part 54 This advance notice of proposed rulemaking announces the intention of the Departments of Health and Human Services, Labor, and the Treasury to propose amendments to regulations regarding certain preventive health services under provisions of the Patient Protection and Affordable Care Act (Affordable Care Act). The proposed amendments would establish alternative ways to fulfill the requirements of section 2713 of the Public Health Service Act and companion provisions under the Employee Retirement Income Security Act and the Internal Revenue Code when health coverage is sponsored or arranged by a religious organization that objects to the coverage of contraceptive services for religious reasons and that is not exempt under the final regulations published February 15, 2012. This document serves as a request for comments in advance of proposed rulemaking on the potential means of accommodating such organizations while ensuring contraceptive coverage for plan participants and beneficiaries covered under their plans (or, in the case of student health insurance plans, student enrollees and their dependents) without cost sharing.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-4430 RIN 0991-AB82 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Proposed rule. To be assured consideration, written or electronic comments must be received at one of the addresses provided below, no later than 5 p.m. on May 7, 2012. 45 CFR Part 170 Under section 3004 of the Public Health Service Act, the Secretary of Health and Human Services is proposing to revise the initial set of standards, implementation specifications, and certification criteria adopted in an interim final rule published on January 13, 2010, and a subsequent final rule that was published on July 28, 2010, as well as to adopt new standards, implementation specifications, and certification criteria. The proposed new and revised certification criteria would establish the technical capabilities and specify the related standards and implementation specifications that Certified Electronic Health Record (EHR) Technology would need to include to, at a minimum, support the achievement of meaningful use by eligible professionals, eligible hospitals, and critical access hospitals under the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in fiscal year and calendar year 2014. This notice of proposed rulemaking also proposes revisions to the permanent certification program for health information technology, which includes changing the program's name.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-4395 RIN 1505-AC30 CMS-9987-F DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF THE TREASURY, Centers for Medicare & Medicaid Services (CMS) Final rule. These regulations are effective on April 27, 2012. 31 CFR Part 33 This final rule sets forth a procedural framework for submission and review of initial applications for a Waiver for State Innovation described in section 1332 of the Patient Protection and the Affordable Care Act including processes to ensure opportunities for public input in the development of such applications by States and in the Federal review of the applications.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-3442 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Administration for Children and Families Notice of tribal consultation. Please submit written comments to the office listed in the ADDRESSES section below on or before April 6, 2012. Please see SUPPLEMENTARY INFORMATION for additional details on consultation meetings. 45 CFR Part 1357 The title IV-B regulations regarding the title IV-B plan and fiscal requirements are outdated due to statutory changes over the last 15 years. The Children's Bureau (CB) is deciding whether to revise the regulations accordingly. Per the ACF Tribal Consultation Policy (76 FR 55678, published September 8, 2011), we request comments from Indian Tribes that operate a title IV-B, subpart 1 and/or title IV-B, subpart 2 program and any other interested party. We provide further information on these statutory changes below, under SUPPLEMENTARY INFORMATION .
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-3014 RIN 0906-AA87 DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration (HRSA) Notice of proposed rulemaking. We invite comments on this proposed rule. To be considered, submit comments on or before April 16, 2012. 45 CFR Parts 60 and 61 This proposed rule revises existing regulations under sections 401-432 of the Health Care Quality Improvement Act of 1986 and section 1921 of the Social Security Act, governing the National Practitioner Data Bank, to incorporate statutory requirements under section 6403 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), Public Law 111-148. The Department of Health and Human Services (HHS) also is removing Title 45 of the Code of Federal Regulations (CFR) part 61, which implemented the Healthcare Integrity and Protection Data Bank. Section 6403 of the Affordable Care Act, the statutory authority for this regulatory action, was designed to eliminate duplicative data reporting and access requirements between the Healthcare Integrity and Protection Data Bank (established under section 1128E of the Social Security Act) and the National Practitioner Data Bank. Section 6403 of the Affordable Care Act requires the Secretary to establish a transition period to transfer all data in the Healthcare Integrity and Protection Data Bank to the National Practitioner Data Bank, and, once completed, to cease operations of the Healthcare Integrity and Protection Data Bank. Information previously collected and disclosed through the Healthcare Integrity and Protection Data Bank will then be collected and disclosed through the National Practitioner Data Bank. This regulatory action consolidates the collection and disclosure of information from both data banks into one part of the CFR.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-3014 RIN 0906-AA87 DEPARTMENT OF HEALTH AND HUMAN SERVICES, HHS, Health Resources and Services Administration (HRSA) Notice of proposed rulemaking. We invite comments on this proposed rule. To be considered, submit comments on or before April 16, 2012. 45 CFR Parts 60 and 61 This proposed rule revises existing regulations under sections 401-432 of the Health Care Quality Improvement Act of 1986 and section 1921 of the Social Security Act, governing the National Practitioner Data Bank, to incorporate statutory requirements under section 6403 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), Public Law 111-148. The Department of Health and Human Services (HHS) also is removing Title 45 of the Code of Federal Regulations (CFR) part 61, which implemented the Healthcare Integrity and Protection Data Bank. Section 6403 of the Affordable Care Act, the statutory authority for this regulatory action, was designed to eliminate duplicative data reporting and access requirements between the Healthcare Integrity and Protection Data Bank (established under section 1128E of the Social Security Act) and the National Practitioner Data Bank. Section 6403 of the Affordable Care Act requires the Secretary to establish a transition period to transfer all data in the Healthcare Integrity and Protection Data Bank to the National Practitioner Data Bank, and, once completed, to cease operations of the Healthcare Integrity and Protection Data Bank. Information previously collected and disclosed through the Healthcare Integrity and Protection Data Bank will then be collected and disclosed through the National Practitioner Data Bank. This regulatory action consolidates the collection and disclosure of information from both data banks into one part of the CFR.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-3228 RIN 1545-BJ94 TD 9575 CMS-9982-F DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, DEPARTMENT OF THE TREASURY, Internal Revenue Service, Employee Benefits Security Administration Final rule. Effective date. These final regulations are effective April 16, 2012. Applicability date. The requirements to provide an SBC, notice of modification, and uniform glossary under PHS Act section 2715 and these final regulations apply for disclosures to participants and beneficiaries who enroll or re-enroll in group health coverage through an open enrollment period (including re-enrollees and late enrollees) beginning on the first day of the first open enrollment period that begins on or after September 23, 2012. For disclosures to participants and beneficiaries who enroll in group health plan coverage other than through an open enrollment period (including individuals who are newly eligible for coverage and special enrollees), the requirements under PHS Act section 2715 and these final regulations apply beginning on the first day of the first plan year that begins on or after September 23, 2012. For disclosures to plans, and to individuals and dependents in the individual market, these requirements are applicable to health insurance issuers beginning on September 23, 2012. 26 CFR Parts 54 and 602 This document contains final regulations regarding the summary of benefits and coverage and the uniform glossary for group health plans and health insurance coverage in the group and individual markets under the Patient Protection and Affordable Care Act. This document implements the disclosure requirements under section 2715 of the Public Health Service Act to help plans and individuals better understand their health coverage, as well as other coverage options. A guidance document published elsewhere in this issue of the Federal Register provides further guidance regarding compliance.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-3230 RIN CMS-9982-FN DEPARTMENT OF HEALTH AND HUMAN SERVICES, DEPARTMENT OF LABOR, DEPARTMENT OF THE TREASURY, Internal Revenue Service, Employee Benefits Security Administration Guidance for compliance and notice of availability of templates, instructions, and related materials. 26 CFR Part 54 The Departments of Health and Human Services, Labor, and the Treasury are simultaneously publishing in the Federal Register this guidance document and final regulations under the Patient Protection and Affordable Care Act to implement the disclosure for group health plans and health insurance issuers of the summary of benefits and coverage (SBC), notice of modifications, and the uniform glossary. This guidance document provides guidance for compliance with section 2715 of the Public Health Service Act and the Departments' final regulations, including a template for the SBC, instructions, sample language, a guide for coverage example calculations, and the uniform glossary.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-1392 RIN NATIONAL SCIENCE FOUNDATION Final rule. Effective February 3, 2012. 45 CFR Part 670 Pursuant to the Antarctic Conservation Act of 1978, The National Science Foundation (NSF) is amending its regulations to reflect newly designated Antarctic Specially Protected Areas (ASPA), Antarctic Specially Managed Areas (ASMA) and Historical Sites or Monuments (HSM). These additions reflect measures already adopted by the Antarctic Treaty Parties at recent Antarctic Treaty Consultative Meetings (ATCM). Finally, the regulation is being revised to correct some typographical and numbering errors.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-2098 RIN LEGAL SERVICES CORPORATION Final rule. Effective Date: This rule is effective February 1, 2012. 45 CFR Part 1611 The Legal Services Corporation (“Corporation”) is required by law to establish maximum income levels for individuals eligible for legal assistance. This document updates the specified income levels to reflect the annual amendments to the Federal Poverty Guidelines as issued by the Department of Health and Human Services.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-1984 RIN LEGAL SERVICES CORPORATION Notice of Proposed Rulemaking. Comments on the NPRM are due April 2, 2012. 45 CFR Parts 1606, 1618, and 1623 This Notice of Proposed Rulemaking (NPRM) proposes amendments to the Legal Services Corporation's regulations on termination procedures, enforcement, and suspension procedures.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-1984 RIN LEGAL SERVICES CORPORATION Notice of Proposed Rulemaking. Comments on the NPRM are due April 2, 2012. 45 CFR Parts 1606, 1618, and 1623 This Notice of Proposed Rulemaking (NPRM) proposes amendments to the Legal Services Corporation's regulations on termination procedures, enforcement, and suspension procedures.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-1984 RIN LEGAL SERVICES CORPORATION Notice of Proposed Rulemaking. Comments on the NPRM are due April 2, 2012. 45 CFR Parts 1606, 1618, and 1623 This Notice of Proposed Rulemaking (NPRM) proposes amendments to the Legal Services Corporation's regulations on termination procedures, enforcement, and suspension procedures.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-132 RIN 0938-AQ11 CMS-0024-IFC DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Interim final rule with comment period. Effective Date: These regulations are effective on January 10, 2012. The incorporation by reference of the publications listed in this interim final rule with comment period is approved by the Director of the Office of the Federal Register January 10, 2012. Compliance Date: The compliance date for this regulation is January 1, 2014. Comment Date: To be assured consideration, comments must be received at one of the addresses provided below on or before March 12, 2012. 45 CFR Parts 160 and 162 This interim final rule with comment period implements parts of section 1104 of the Affordable Care Act which requires the adoption of a standard for electronic funds transfers (EFT). It defines EFT and explains how the adopted standards support and facilitate health care EFT transmissions.
GPO FDSys XML | Text type regulations.gov FR Doc. 2012-132 RIN 0938-AQ11 CMS-0024-IFC DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary Interim final rule with comment period. Effective Date: These regulations are effective on January 10, 2012. The incorporation by reference of the publications listed in this interim final rule with comment period is approved by the Director of the Office of the Federal Register January 10, 2012. Compliance Date: The compliance date for this regulation is January 1, 2014. Comment Date: To be assured consideration, comments must be received at one of the addresses provided below on or before March 12, 2012. 45 CFR Parts 160 and 162 This interim final rule with comment period implements parts of section 1104 of the Affordable Care Act which requires the adoption of a standard for electronic funds transfers (EFT). It defines EFT and explains how the adopted standards support and facilitate health care EFT transmissions.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-32911 RIN 0970-AC41 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Administration for Children and Families Interim final rule. This rule is effective February 6, 2012. Consideration will be given to all comments received by March 6, 2012. 45 CFR Parts 1355 and 1356 The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E benefits or medical assistance under title XIX of the Act (Medicaid) and such services or payments; in-kind expenditures from third-party sources for the Tribal share of administration and training expenditures under title IV-E; and other provisions to carry out the Tribal-related amendments to title IV-E. This interim final rule includes these provisions and technical amendments necessary to implement a Tribal title IV-E program.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-32911 RIN 0970-AC41 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Administration for Children and Families Interim final rule. This rule is effective February 6, 2012. Consideration will be given to all comments received by March 6, 2012. 45 CFR Parts 1355 and 1356 The Administration for Children and Families (ACF) is issuing this interim final rule to implement statutory provisions related to the Tribal title IV-E program. Effective October 1, 2009, section 479B(b) of the Social Security Act (the Act) authorizes direct Federal funding of Indian Tribes, Tribal organizations, and Tribal consortia that choose to operate a foster care, adoption assistance and, at Tribal option, a kinship guardianship assistance program under title IV-E of the Act. The Fostering Connections to Success and Increasing Adoptions Act of 2008 requires that ACF issue interim final regulations which address procedures to ensure that a transfer of responsibility for the placement and care of a child under a State title IV-E plan to a Tribal title IV-E plan occurs in a manner that does not affect the child's eligibility for title IV-E benefits or medical assistance under title XIX of the Act (Medicaid) and such services or payments; in-kind expenditures from third-party sources for the Tribal share of administration and training expenditures under title IV-E; and other provisions to carry out the Tribal-related amendments to title IV-E. This interim final rule includes these provisions and technical amendments necessary to implement a Tribal title IV-E program.
GPO FDSys XML | Text type regulations.gov FR Doc. 2011-33336 RIN DEPARTMENT OF HEALTH AND HUMAN SERVICES, Administration for Children and Families Notice of Tribal Consultation. The meeting dates and times for teleconferences are: • February 15, from 1-3 p.m. EST. • February 16, from 3-5 p.m. EST. Access information for these teleconferences is in the Supplementary Information section. Written comments must be submitted to the office listed in the ADDRESSES section below on or before April 6, 2012. 45 CFR Part 1355 Title IV-E rules provide Federal Financial Participation (FFP) through a beneficial cost allocation methodology if a State or Tribe implements a comprehensive Statewide Automated Child Welfare Information System (SACWIS) to track and manage child protection, foster care and adoption assistance activities. With the continuing implementation of the Fostering Connections to Success and Increasing Adoptions Act of 2008 (Pub. L. 110-351) we wish to analyze the impact of the State-centric SACWIS rules on Tribes and Tribal child welfare agencies, to determine if Tribes have sufficient flexibility and latitude to build information systems that will meet their business needs. The Children's Bureau's (CB) Division of State Systems (DSS) has been assigned responsibility to undertake consultation with Tribes in this area. To offer Tribes the opportunity for informed comment on the implications that the State-centric rules have on their ability to build and operate information systems that will support their title IV-E programs, we will provide an education session on the SACWIS regulations. This will be followed by a consultation to listen to the concerns and ideas from Tribal leaders and their representatives about the existing SACWIS rules and how CB can support title IV-E Tribal agencies in building information systems that will meet their business needs. We propose two such combined meetings via teleconferences to reach a broad audience of interested parties. The teleconference on February 15, 2012, is intended for consultation with Tribal leaders; the teleconference on February 16, 2012, is intended to engage in consultation with their representatives.