May 18
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CMS
Notices:
- CMS is seeking comments on a proposed collection entitled: The Home and Community-Based Service (HCBS) Experience Survey. This study is a one-time pilot field test involving individuals who receive HCBS from Medicaid programs. The field test to be conducted under this request will be done for the following purposes: (a) To assess survey methodology--to determine how well a face-to-face survey and telephone survey performs with individuals who receive HCBS services. (b) Psychometric Analysis — to provide information for the revision and shortening of the survey based on the assessment of the reliability and construct validity of survey items and composites. (c) Case mix adjustment analysis--Assess the variables that may be considered as case mix adjusters.
These preliminary research activities are not required by regulation, and will not be used by CMS to regulate or sanction its customers. They will be entirely voluntary and the confidentiality of respondents and their responses will be preserved.
The information collected will be used to revise and test the survey instrument described in the Background section of the Supporting Statement. Within the PRA package, Attachment B includes two versions of the survey (one modified for accessibility) and Attachment C has the introductory information. The end result will be an improvement in information collection instruments and in the quality of data collected, a reduction or minimization of respondent burden, increased agency efficiency, and improved responsiveness to the public. Following the field test, CMS will seek approval from the CAHPS consortium for the HCBS Experience Survey to be a new addition to the CAHPS family of surveys. FR, Pages 29644-29645
- CMS is seeking comments on a proposed collection entitled: Cooperative Agreement to Support Establishment of the Affordable Care Act's Health Insurance Exchanges. All States (including the 50 States, consortia of States, and the District of Columbia, herein referred to as States) are eligible for the Cooperative Agreement to Support Establishment of the Affordable Care Act's Health Insurance Exchanges. Section 1311 of the Affordable Care Act provides for grants to States for the planning and establishment of these Exchanges. Given the innovative nature of Exchanges and the statutorily-prescribed relationship between the Secretary and States in their development and operation, it is critical that the Secretary work closely with States to provide necessary guidance and technical assistance to ensure that States can meet the prescribed timelines, federal requirements, and goals of the statute.
In order to provide appropriate and timely guidance and technical assistance, the Secretary must have access to timely, periodic information regarding State progress. Consequently, the information collection associated with these grants is essential to facilitating reasonable and appropriate federal monitoring of funds, providing statutorily-mandated assistance to States to implement Exchanges in accordance with Federal requirements, and to ensure that States have all necessary information required to proceed, such that retrospective corrective action can be minimized.
There are two levels of awards for States to apply for the Establishment grants. Level One grants are open to States that are participating in either the Federally-facilitated Exchange, including States that will be collaborating with the Federally-facilitated Exchange on certain activities, or developing a State-based Exchange. Level Two Establishment grants are open to States that are establishing a State-based Exchange. Level One Establishment grantees may apply for additional funding under Level Two Establishment grants once they have achieved the benchmarks identified in the Level Two Establishment review criteria.
HHS anticipates releasing this funding opportunity on June 15, 2012. There will be ten opportunities for applicants to apply for funding. FR, Pages 29646-29647
- CMS is seeking comments on a proposed collection entitled: Blueprint for Approval of Affordable State-based and State Partnership Insurance Exchanges. All States (including the 50 States, the Territories, and the District of Columbia herein referred to as States) have the opportunity under Section 1311(b) of the Affordable Care Act to establish an Exchange no later than October 1, 2013 (Plan Year 2014).
Given the innovative nature of Exchanges and the statutorily-prescribed relationship between the Secretary and States in their development and operation, it is critical that the Secretary work closely with States to provide necessary guidance and technical assistance to ensure that States can meet the prescribed timelines, federal requirements, and goals of the statute.
States seeking to establish an Exchange must build an Exchange that meets the requirements set out in Section 1311(d) of the Affordable Care Act and 45 CFR 155.105. In order to ensure that a State seeking approval as a State Exchange or State Partnership Exchange in the Federally-facilitated Exchange meet all applicable requirements the Secretary will require a State to submit a Blueprint for approval during the Fall of 2012 and to demonstrate operational readiness through virtual or on-site readiness review. The Blueprint has two sections: The Blueprint Declaration Letter and the Blueprint Application. Submission of this Blueprint Declaration Letter will be online and on paper and submission of the Blueprint Application will be online. FR, Pages 29646-29647
May 17
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HHS
Notice:
- HHS is seeking public comment on extending a currently approved collection entitled: Public Health Service Policies on Research Misconduct. The purpose of the Annual Report on Possible Research Misconduct (Annual Report) form is to provide data on the amount of research misconduct activity occurring in institutions conducting PHS supported research. In addition this provides an annual assurance that the institution has established and will follow administrative policies and procedures for responding to allegations of research misconduct that comply with the Public Health Service (PHS) Policies on Research Misconduct (42 CFR part 93). Research misconduct is defined as receipt of an allegation of research misconduct and/or the conduct of an inquiry and/or investigation into such allegations. These data enable the ORI to monitor institutional compliance with the PHS regulation. Lastly, the form will be used to respond to congressional requests for information to prevent misuse of Federal funds and to protect the public interest. FR, Pages 29348-29349
May 16
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CMS
Final Rule:
This final rule identifies reforms in Medicare and Medicaid regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries. This rule increases the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert providing high quality patient care. This is one of several rules that CMS said it’s finalizing to achieve regulatory reforms under Executive Order 13563 on Improving Regulation and Regulatory Review and the Department's Plan for Retrospective Review of Existing Rules. These regulations are effective on July 16, 2012. FR, Pages 29002-29031
This final rule revises the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These changes are an integral part of our efforts to reduce procedural burdens on providers. This rule reflects CMS’ commitment to the general principles of the President's Executive Order 13563, released January 18, 2011, entitled "Improving Regulation and Regulatory Review.” These regulations are effective on July 16, 2012. FR, Pages 29034-29076
HHS
Interim Final Rule; Correcting Amendment:
- This document corrects technical errors that appeared in the interim final rule published in the Federal Register on Dec. 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.''
Effective date is May 16, 2012. FR, Pages 28788-28790
Final Rule:
- 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 rule is effective on June 15, 2012. The amendments generally apply beginning July 1, 2012, to health insurance issuers offering group or individual health insurance coverage. FR, Pages 28790-28797
May 15
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FDA
Notices:
- The FDA is seeking comments on extending its collection entitled: Guidance for Industry on Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
On December 22, 2006, the President signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, 120 Stat. 3469). This law amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) with respect to serious adverse event reporting for dietary supplements and nonprescription drugs marketed without an approved application.
Section 502(x) of the FD&C Act (21 U.S.C. 352(x)), which was added by Public Law 109-462, requires the label of a nonprescription drug product marketed without an approved application in the United States to include a domestic address or domestic telephone number through which a responsible person may receive a report of a serious adverse event associated with the product. The guidance document contains questions and answers relating to this labeling requirement and provides guidance to industry on the following topics: (1)
The meaning of ``domestic address'' for purposes of the labeling requirements of section 502(x) of the FD&C Act; (2) FDA's recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 502(x) of the FD&C Act; and (3) FDA's intent regarding enforcing the labeling requirements of section 502(x) of the FD&C Act. Separate guidance, issued by the Center for Food Safety and Applied Nutrition on reporting for dietary supplements, is announced elsewhere in the Federal Register.
Comments are due by July 16, 2012. FR, Pages 28604-28605
HHS
Request for Information:
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.
Comments are due by June 14, 2012. FR, Pages 28543-28560
May 14
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NIH
Notice:
- NIH is seeking comments on extending its collection entitled: Proposed Collection: Hazardous Waste Worker Training.
This request for OMB review and approval of the information collection is required by regulation 42 CFR part 65(a)(6). The National Institute of Environmental Health Sciences (NIEHS) was given major responsibility for initiating a worker safety and health training program under Section 126 of the Superfund Amendments and Reauthorization Act of 1986 (SARA) for hazardous waste workers and emergency responders. A network of non-profit organizations that are committed to protecting workers and their communities by delivering high-quality, peer-reviewed safety and health curricula to target populations of hazardous waste workers and emergency responders has been developed. In twenty-four years (FY 1987-2011), the NIEHS Worker Training program has successfully supported 20 primary grantees that have trained more than 2.7 million workers across the country and presented over 160,913 classroom and hands-on training courses, which have accounted for nearly 36 million contact hours of actual training. Generally, the grant will initially be for one year, and subsequent continuation awards are also for one year at a time. Grantees must submit a separate application to have the support continued for each subsequent year. Grantees are to provide information in accordance with S65.4(a), (b), (c) and 65.6(a) on the nature, duration, and purpose of the training, selection criteria for trainees' qualifications and competency of the project director and staff, cooperative agreements in the case of joint applications, the adequacy of training plans and resources, including budget and curriculum, and response to meeting training criteria in OSHA's Hazardous Waste Operations and Emergency Response Regulations (29 CFR 1910.120). As a cooperative agreement, there are additional requirements for the progress report section of the application. Grantees are to provide their information in hard copy as well as enter information into the WETP Grantee Data Management System. The information collected is used by the Director through officers, employees, experts, and consultants to evaluate applications based on technical merit to determine whether to make awards. FR, Pages 28395-28396
