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.
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.
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 .
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.
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.
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.
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.
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.
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.
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.
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.”
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.”
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.”
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to Title 45 after this date.
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.
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.
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.
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.
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.
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 .
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.
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.
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.
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.
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.
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.
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 .
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.
This Notice of Proposed Rulemaking (NPRM) proposes amendments to the Legal Services Corporation's regulations on termination procedures, enforcement, and suspension procedures.
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.
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