Department of Health and Human Services December 13, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review
The Food and Drug Administration (FDA) is announcing the availability of a draft report entitled ``Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review'' (literature review report). A literature review was conducted to address a requirement of the Patient Protection and Affordable Care Act (Affordable Care Act). FDA is publishing the literature review report to allow the public to provide comment on the report as it relates to the Affordable Care Act.
Early Retiree Reinsurance Program
This notice announces that CMS, based on the projected availability of funding under the Early Retiree Reinsurance Program (ERRP), is exercising its authority under the ERRP regulations at 45 CFR 149.45(a) to deny ERRP reimbursement requests, in their entirety, that include claims that are incurred after December 31, 2011. Therefore, plan sponsors must not include such claims in their Claim Lists and Summary Cost Data submitted in support of a reimbursement request. Should circumstances related to the availability of ERRP funding change, CMS may issue a new notice announcing approval of ERRP reimbursement request that include claims incurred after December 31, 2011.
Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. Devices that receive HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption (HDE) marketing pathway. This guidance document is intended to assist applicants in the preparation and submission of HUD designation requests and FDA reviewers in evaluating such requests.
Patient Protection and Affordable Care Act; Establishment of Consumer Operated and Oriented Plan (CO-OP) Program
This final rule implements the Consumer Operated and Oriented Plan (CO-OP) program, which provides loans to foster the creation of consumer-governed, private, nonprofit health insurance issuers to offer qualified health plans in the Affordable Insurance Exchanges (Exchanges). The goal of this program is to create a new CO-OP in every State in order to expand the number of health plans available in the Exchanges with a focus on integrated care and greater plan accountability.
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