Agency for Healthcare Research and Quality – Federal Register Recent Federal Regulation Documents

Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act to enact section 1139A (42 U.S.C.1320b-9a). Section 1139A(b) charged the Department of Health and Human Services (HHS) with improving pediatric health care quality measures. The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of measures of children's healthcare quality for potential inclusion in the CHIPRA 2013 Improved Core Set of Health Care Quality Measures (the ``Improved Core Set'') for potential voluntary use by Medicaid and the Children's Health Insurance Program. In addition, CHIPRA established the Pediatric Quality Measures Program to increase the portfolio of measures available to public and private purchasers of children's health care services, providers, and consumers. HHS anticipates that measures ultimately included in the Improved Core Set will also be used by public and private purchasers to measure pediatric healthcare quality. AHRQ is interested in information about the importance, scientific validity, and feasibility of the measures. If a measure is selected for inclusion, more information, including a copyright release (if applicable) and full measure specifications would be needed.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of peripheral artery disease treatment medical devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of Treatment Strategies for Patients with Peripheral Artery Disease (PAD), which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of unresectable colorectal cancer medical devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of Local Therapies for Unresectable Colorectal Cancer Metastases to the Liver, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Act (at 42 U.S.C. 299b-23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70731-70814. AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow health care providers to voluntarily collect and submit standardized information regarding patient safety events. In order to support the Common Formats, AHRQ has provided technical specifications to promote standardization by ensuring that data collected by PSOs and other entities are clinically and electronically comparable. More information on the Common Formats, including the technical specifications, can be obtained through AHRQ's PSO Web site: https://www.PSO.AHRQ.GOV/. The purpose of this notice is to announce a meeting to discuss the Common Formats technical specifications. This meeting is designed as an interactive forum where PSOs and software developers can provide input on these technical specifications. AHRQ especially requests input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the formats electronically.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Assessing the Feasibility of Disseminating Effective Health Center Products through Mobile Phone Applications.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on November 15th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Assessing the Feasibility of Disseminating Effective Health Care Products through a Shared Electronic Medical Record Serving Member Organization of a Health Information Exchange.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on November 15th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b- 9a). Section 1139A(b) charged the Department of Health and Human Services with improving pediatric health care quality measures. The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of instruments or domains (for example, key concepts) measuring aspects of families' experience with the quality of inpatient medical and surgical hospital care from all researchers, vendors, hospitals, stakeholders, and other interested parties. The survey development team of Children's Hospital Boston Center of Excellence for Pediatric Quality Measurement (CEPQM), is one of the CHIPRA Pediatric Quality Measures Program (PQMP) Centers of Excellence, which were created pursuant to an interagency agreement between the Centers for Medicare & Medicaid Services (CMS) and AHRQ, and are funded through cooperative agreement awards with AHRQ. AHRQ is interested in instruments and items through which families of pediatric patients assess the care their child receives during the child's inpatient stay. The goal is to develop a standardized instrument for use in the public reporting of family experience of pediatric inpatient care. The CEPQM team is collaborating with the CAHPS 3 Consortium to develop this instrument. The survey will be developed in accordance with CAHPS Survey Design Principles and will develop implementation instructions based on those for CAHPS instruments (https://www.cahps.AHRQ.gov/About- CAHPS/principles.aspx.) All CAHPS surveys are available to users free of charge and are published on the AHRQ Web site. This notice is republished because of technical clarification.

Section 401(a) of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), Public Law 111-3, amended the Social Security Act (the Act) to enact section 1139A (42 U.S.C. 1320b- 9a). Section 1139A(b) charged the Department of Health and Human Services with improving pediatric health care quality measures. The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of instruments or domains (for example, key concepts) measuring aspects of families' experience with the quality of inpatient medical and surgical hospital care from all researchers, vendors, hospitals, stakeholders, and other interested parties. The survey development team of Children's Hospital Boston Center of Excellence for Pediatric Quality Measurement (CEPQM), is one of the CHIPRA Pediatric Quality Measures Program (PQMP) Centers of Excellence, which were created pursuant to an interagency agreement between the Centers for Medicare & Medicaid Services (CMS) and AHRQ, and are funded through cooperative agreement awards with AHRQ. AHRQ is interested in instruments and items through which families of pediatric patients assess the care their child receives during the child's inpatient stay. The goal is to develop a standardized instrument for use in the public reporting of family experience of pediatric inpatient care. The team developing this survey intends to submit it to the CAHPS Consortium to request use of the CAHPS trademark. The survey will be developed in accordance with CAHPS Survey Design Principles and will develop implementation instructions based on those for CAHPS instruments (https://www.cahps.AHRQ.gov/About-CAHPS/Principles.aspx.) All CAHPS surveys are available to users free of charge and are published on the AHRQ Web site.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of CYP2C19 variants and platelet reactivity tests. Scientific information is being solicited to inform our Comparative Effectiveness Review of Testing of CYP2C19 Variants and Platelet Reactivity for Guiding Antiplatelet Treatment, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of pressure ulcer treatment medical devices, such as (but not limited to): Ultrasonic wound care systems, negative pressure therapy units, turning & positioning systems, special mattresses, mattress covers, pillows, cushions, etc. Scientific information is being solicited to inform our Pressure Ulcer Treatment Strategies: A Comparative Effectiveness Review, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on these devices will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Group Survey Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Assessing the Feasibility of Disseminating EHC Products through Educational Activities.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

AHRQ has accepted a notification of voluntary relinquishment from Emergency Medicine Patient Safety Foundation of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b21-b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Assessing the Feasibility of Disseminating Effective Health Center Products through Mobile Phone Applications.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of ARRA Comparative Effectiveness Research Dissemination Contractor Efforts.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 27th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``MEPS Cancer Self Administrated Questionnaire.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from manufacturers of Phototherapy medical devices for treatment of chronic plaque psoriasis. Scientific information is being solicited to inform our Comparative Effectiveness Review of Biologic and Nonbiologic Systemic Agents and Phototherapy for Treatment of Chronic Plaque Psoriasis, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) Quality Demonstration Grant Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 3rd, 2011 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the Technical Assistance to ARRA Complex Patient Grantees Project.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 3rd, 2011, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

Illinois PSO: AHRQ has accepted a notification of voluntary relinquishment from the Illinois PSO of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

HPI-PSO: AHRQ has accepted a notification of voluntary relinquishment from The Patient Safety Group of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b- 21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Health Literacy Item Set Supplemental to CAHPS Health Plan SurveyPretest of Proposed Questions and Methodology.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 7th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the Technical Assistance to ARRA Complex Patient Grantees Project'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.