Federal Register
Week of May 14, 2012 - May 18, 2012

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

Week of May 7, 2012 - May 11, 2012

May 11

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CMS

Notice:

  • CMS is extending the comment period for the existing information collection entitled “Hospice Survey and Deficiencies Report Form and Supporting Regulations.” CMS is also proposing a new information collection, “Evaluation of Patient Satisfaction and Experience of Care for Medicare Beneficiaries with End-Stage Renal Disease (ESRD): Impact of the ESRD Prospective Payment System (PPS) and ESRD Quality Incentive Program (QIP).” FR, Pages 27777-27778

Proposed Rules:

  • CMS has released a proposed rule that would implement new requirements in Sections 1902(a)(13), 1902(jj), 1932(f), and 1905(dd) of the Social Security Act, as amended by the Patient Protection and Affordable Care Act of 2010. It implements Medicaid payment for primary care services furnished by certain physicians in calendar years (CYs) 2013 and 2014 at rates not less than the Medicare rates in effect in those CYs or, if greater, the payment rates that would be applicable in those CYs using the CY 2009 Medicare physician fee schedule conversion factor (CF). This proposed rule would also update the interim regional maximum fees that providers may charge for the administration of pediatric vaccines to federally vaccine-eligible children under the Pediatric Immunization Distribution Program, more commonly known as the Vaccines for Children (VFC) program. FR, Pages 27671-27691

  • CMS has released a proposed rule to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from the agency’s continuing experience with these systems, and to implement certain statutory provisions contained in the Affordable Care Act and other legislation. These changes would be applicable to discharges occurring on or after Oct. 1, 2012. CMS is also proposing to update the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The updated rate-of-increase limits would be effective for cost reporting periods beginning on or after Oct. 1, 2012.

CMS also proposes to update the payment policy and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) and implementing certain statutory changes made by the Affordable Care Act. These proposed changes would be applicable to discharges occurring on or after Oct. 1, 2012. In addition, CMS is proposing changes relating to determining a hospital’s fulltime equivalent (FTE) resident cap for the purpose of graduate medical education (GME) and indirect medical education (IME) payments. CMS is proposing new requirements or revised requirements for quality reporting by specific providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities (IPFs)) that are participating in Medicare.

CMS is also proposing new administrative, data completeness, and extraordinary circumstance waivers or extension requests requirements, as well as a reconsideration process, for quality reporting by ambulatory surgical centers (ASCs) that are participating in Medicare. CMS is proposing requirements for the Hospital Value-Based Purchasing (VBP) Program and the Hospital Readmissions Reduction Program. FR, Pages 27870-28192

May 10

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FDA

Notice:

  • FDA is announcing the availability of the draft guidance entitled “Pediatric Information for X-ray Imaging Device Premarket Notifications.” This draft guidance document outlines FDA’s current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations on information to support such indications. This draft guidance is not final nor is it in effect at this time. FR, Pages 27461-27463

May 9

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FDA

Notice:

  • FDA has announced a notice that solicits comments on the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002. FR, Pages 27234-27235

May 8

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CDC

Notice:

  • The CDC requests OMB approval to collect program evaluation data from training participants in programs regarding fetal alcohol spectrum disorders (FASDs) conducted by the FASD Regional Training Centers (RTCs) through a cooperative agreement with the CDC. FR, Pages 27067-27070

May 7

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CMS

Notices:

  • CMS is publishing a proposed information collection request on the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) competitive bidding program. FR, Pages 26763-26764

  • CMS has published a final rule that implements Section 2401 of the Affordable Care Act, which establishes a new state option to provide home and community-based attendant services and supports, known as Community First Choice (CFC). While the final rule sets forth the requirements for implementation of CFC, CMS is not finalizing the section concerning the CFC setting. FR, Pages 26828-26903

FDA

Notice:

  • The FDA has determined the regulatory review period for PROLIA, indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture, and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product. FR, Page 26768
Week of April 30, 2012 - May 4, 2012

May 4

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FDA

Notices:

  • The FDA has determined the regulatory review period for GILENYA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. FR, Pages 2012-10819

  • The FDA has determined the regulatory review period for EGRIFTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. FR, Pages 26555-26556

  • The FDA has determined the regulatory review period for EQUIDONE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. FR, Pages 26556-26557

  • The FDA has determined the regulatory review period for FERAHEME and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. FR, Pages 26557-26558

  • The FDA has determined the regulatory review period for JEVTANA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. FR, Pages 26558-26559

May 3

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CMS

Proposed Rule:

  • This proposed rule would revise Medicaid regulations to define and describe state plan home and community-based services (HCBS) under the Social Security Act (the Act) as added by the Deficit Reduction Act of 2005 and amended by the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act \1). This proposed rule offers States new flexibility in providing necessary and appropriate services to elderly and disabled populations and reflects CMS' commitment to the general principles of the President's Executive Order released January 18, 2011, entitled “Improving Regulation and Regulatory Review.” In particular, this rule does not require the eligibility link between HCBS and institutional care that exists under the Medicaid HCBS waiver program. This regulation would describe Medicaid coverage of the optional State plan benefit to furnish home and community-based services and receive Federal matching funds. As a result, states will be better able to design and tailor Medicaid services to accommodate individual needs. This may result in improved patient outcomes and satisfaction, while enabling States to effectively manage their Medicaid resources. Comments are due by July 2, 2012 FR, Pages 26362-26406

FDA

Notices:

  • The FDA has determined the regulatory review period for HALAVEN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. FR, Pages 26288-26289

  • The FDA has determined the regulatory review period for PRADAXA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. FR, Pages 26289-26290

  • The FDA has determined the regulatory review period for KRYSTEXXA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. FR, Pages 26290-26291

  • The FDA has determined the regulatory review period for LASTACAFT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. FR, Pages 26291-26292

May 2

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FDA

Notice:

  • The FDA has determined the regulatory review period for KALBITOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product. FR, Pages 26017-26018

  • The FDA has determined the regulatory review period for Victoza and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. FR, Pages 26018-26019

May 1

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CMS

Request for Information:

  • CMS issued this document as a request for information regarding the use of stop-loss insurance by group health plans and their plan sponsors, with a focus on the prevalence and consequences of stop-loss insurance at low attachment points. Given the limited nature of data available, the Departments of Labor, HHS, and the Treasury invite public comments via this request for information. Comments must be submitted on or before July 2, 2012. FR, Pages 25788-25790

FDA

Notice:

  • The FDA has determined that GRIFULVIN V (griseofulvin microcrystalline) tablets, 250 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for griseofulvin microcrystalline tablets, 250 mg, if all other legal and regulatory requirements are met. FR, Pages 25720-25721

April 30

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FDA

Final Rule:

  • The FDA is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.This rule is effective May 30, 2012. . FR, Pages 25353-25361
Week of April 23, 2012 - April 27, 2012

April 27

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CMS

Notice:

  • CMS is seeking public comment on a revision of a currently approved collection: entitled Medicare Health Outcomes Survey (HOS). CMS has a responsibility to its Medicare beneficiaries to require that care provided by managed care organizations under contract to CMS is of high quality. One way of ensuring high quality care in Medicare Managed Care Organizations (MCOs), or more commonly referred to as Medicare Advantage Organizations (MAOs), is through the development of standardized, uniform performance measures to enable CMS to gather the data needed to evaluate the care provided to Medicare beneficiaries. The goal of the Medicare Health Outcome Survey (HOS) program is to gather valid, reliable, clinically meaningful health status data in Medicare managed care for use in quality improvement activities, plan accountability, public reporting, and improving health. All managed care plans with Medicare Advantage (MA) contracts must participate. CMS, in collaboration with the National Committee for Quality Assurance (NCQA), launched the Medicare HOS as part of the Effectiveness of Care component of the former Health Plan Employer Data and Information Set, now known as the Healthcare Effectiveness Data and Information Set (HEDIS

The HOS measure was developed under the guidance of a technical expert panel comprised of individuals with specific expertise in the health care industry and outcomes measurement. The measure includes the most recent advances in summarizing physical and mental health outcomes results and appropriate risk adjustment techniques. In addition to health outcomes measures, the HOS is used to collect the Management of Urinary Incontinence in Older Adults, Physical Activity in Older Adults, Fall Risk Management, and Osteoporosis Testing in Older Women HEDIS measures. The collection of Medicare HOS is necessary to hold Medicare managed care contractors accountable for the quality of care they are delivering. This reporting requirement allows CMS to obtain the information necessary for proper oversight of the Medicare Advantage program.

Since the last collection, the survey instrument has been revised and the burden has changed. There have been some questions added and others deleted. FR, Pages 25181-25182

  • CMS is seeking public comment on the reinstatement with change of a previously approved collection entitled: Site Investigation for Durable Medical Equipment (DME) Suppliers. CMS is mandated to identify and implement measures to prevent fraud and abuse in the Medicare program. To meet this challenge, CMS has moved forward to improve the quality of the process for enrolling suppliers into the Medicare program by establishing a uniform application for enumerating suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).

Implementation of enhanced procedures for verifying the enrollment information has also improved the enrollment process. As part of this process, verification of compliance with supplier standards is necessary. The site investigation form has been used in the past to aid the Medicare contractor (the National Supplier Clearinghouse and/or its subcontractors) in verifying compliance with the required supplier standards found in 42 CFR 424.57(c). The primary function of the site investigation form is to provide a standardized, uniform tool to gather information from a DMEPOS supplier that tells us whether it meets certain qualifications to be a DMEPOS supplier (as found in 42 CFR 424.57(c)) and where it practices or renders its services.

This site investigation form collects the same information as its predecessor, with the exception of one new yes/no question under the “Records and Telephone" section (question 11(a)) used to verify if the DMEPOS supplier maintains physician ordering/referring records for the supplies and/or services it renders to Medicare beneficiaries (if applicable). This information is required by section 1833(q) of the Social Security Act (the Act) which states that all physicians and non-physician practitioners that meet the definitions at section 1861(r) and 1842(b)(18)(C) of the Act, be uniquely identified for all claims for services that are ordered or referred. Other information collected on this site investigation remains unchanged, but has been reformatted for greater functionality. FR, Pages 25182-25183

Final Rule:

  • This final rule finalizes several provisions of the Affordable Care Act implemented in the May 5, 2010 interim final rule with comment period. It requires all providers of medical or other items or services and suppliers that qualify for a National Provider Identifier (NPI) to include their NPI on all applications to enroll in the Medicare and Medicaid programs and on all claims for payment submitted under the Medicare and Medicaid programs. In addition, it requires physicians and other professionals who are permitted to order and certify covered items and services for Medicare beneficiaries to be enrolled in Medicare. Finally, it mandates document retention and provision requirements on providers and supplier that order and certify items and services for Medicare beneficiaries.

Effective June 26, 2012 the interim final rule amending 42 CFR parts 424 and 431 that published on May 5, 2010 (75 FR 24437) is confirmed as final with changes. FR, Pages 25284-25318

April 26

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FDA

Notice:

  • The FDA is submitting to OMB for review and clearance an extension to a previously approved collection entitled: Prescription Drug Product Labeling; Medication Guide Requirements.

FDA regulations require the distribution of patient labeling, called Medication Guides, for certain prescription human drug and biological products used primarily on an outpatient basis that pose a serious and significant public health concern requiring distribution of FDA-approved patient medication information. These Medication Guides inform patients about the most important information they should know about these products in order to use them safely and effectively. Included is information such as the drug's approved uses, contraindications, adverse drug reactions, and cautions for specific populations, with a focus on why the particular product requires a Medication Guide. These regulations are intended to improve the public health by providing information necessary for patients to use certain medication safely and effectively. FR, Pages 24961-24962

April 25

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FDA

Notice:

  • THE FDA is withdrawing approval of a new drug application (NDA) for IRESSA (gefitinib) Tablets held by AstraZeneca Pharmaceuticals LP. AstraZeneca has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing. Effective April 25, 2012. FR, Pages 24723-24724

  • The FDA is withdrawing approval of a new drug application (NDA) for OFORTA (fludarabine phosphate) Tablets held by sanofi-aventis, U.S., LLC. Sanofi-aventis has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing. Effective December 31, 2011. FR, Page 24724

April 24

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CMS

Final Rule; Correction:

  • This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on Nov. 30, 2011, entitled "Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment; Ambulatory Surgical Center Payment; Hospital Value-Based Purchasing Program; Physician Self-Referral; and Patient Notification Requirements in Provider Agreements'' and in the correction notice published in the Federal Register on Jan. 4, 2012, entitled "Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment; Ambulatory Surgical Center Payment; Hospital Value-Based Purchasing Program; Physician Self-Referral; and Patient Notification Requirements in Provider Agreements; Corrections.''

This document is effective on April 24, 2012. Applicability Date: The corrections noted in this document and posted on the CMS Web site are applicable to payments on or after Jan. 1, 2012. FR, Pages 24409-24415

HHS

Notice:

  • The HHS Office of Research Integrity (ORI) is seeking comments on the proposed project: Evaluation of the effectiveness of an educational interactive video on research integrity.

ORI proposes to conduct a web based survey evaluation study of the effectiveness of an educational interactive video on research integrity. This study is web-based survey of research faculty/instructors, Research Integrity Officers (RIOs) and Research Administrators' perceptions of the effectiveness of this educational interactive video.

The study seeks to answer two questions: (a) Do researchers feel that this DVD would enhance their teaching of research integrity issues? (b) Will researchers use this DVD in future research methodology or ethics courses? Both hypotheses will be tested with a customer satisfaction type survey. A portion of the survey will collect data on respondent demographics to enable subanalyses on important subpopulations. Participants will be research instructors/faculty, Research Integrity Officers (RIOs) and Research Administrators) who have experience with the ORI educational programs or who may have experience with RCR programs in the near future. The information to be collected will be used by the ORI to help gain additional insight regarding the effectiveness of this educational interactive video, and determining whether it meets our customers' needs and ORI's mission and goals. FR, Pages 24494-24495

April 23

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HHS

Notice:

  • The HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) is requesting the OMB approval on a new collection to evaluate the implementation of a new policy known as Express Lane Eligibility (ELE). With ELE, a state's Medicaid and/or Children's Health Insurance Program (CHIP) can rely on another agency's eligibility findings to qualify children for health coverage, despite their different methods of assessing income or otherwise determining eligibility.

CHIPRA authorized an extensive, rigorous evaluation of ELE, creating an exceptional opportunity to document ELE implementation across states and to assess the changes to coverage or administrative costs that may have resulted. The evaluation also provides an opportunity to understand other methods of simplified enrollment that states have been pursuing and to assess the benefits and potential costs of these methods compared to those of ELE. To answer key research questions, ASPE will draw on 5 primary data collections including (1) Collecting administrative cost data from ELE and non-ELE states, (2) collecting enrollment data from ELE and non-ELE states, (3) conducting case studies in ELE and non-ELE states, including key informant interviews and focus groups, (4) conducting a 51-state (50 states and the District of Columbia) survey, and (5) holding quarterly monitoring calls with 30 states. This request seeks clearance on all data collections except the collection of administrative cost and enrollment data for ELE states. FR, Pages 24206-24207

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Managed Medicare & Medicaid Factbook 2012
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The AIS Guide to Blue Cross and Blue Shield Plans: 2012
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