Department of Health and Human Services March 2014 – Federal Register Recent Federal Regulation Documents

This notice informs interested parties of an opportunity to apply for participation in the Medicare Care Choices Model. The primary goal of the Medicare Care Choices Model is to test whether Medicare beneficiaries who meet Medicare hospice eligibility requirements would elect hospice if they could continue to seek curative services.

This proposed rule addresses various requirements applicable to health insurance issuers, Affordable Insurance Exchanges (``Exchanges''), Navigators, non-Navigator assistance personnel, and other entities under the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act). Specifically, the rule proposes standards related to product discontinuation and renewal, quality reporting, non-discrimination standards, minimum certification standards and responsibilities of qualified health plan (QHP) issuers, the Small Business Health Options Program, and enforcement remedies in Federally-facilitated Exchanges. It also proposes: A modification of HHS's allocation of reinsurance contributions collected if those contributions do not meet our projections; certain changes to the ceiling on allowable administrative expenses in the risk corridors calculation; modifications to the way we calculate certain cost-sharing parameters so that we round those parameters down to the nearest $50 increment; certain approaches we are considering to index the required contribution used to determine eligibility for an exemption from the shared responsibility payment under section 5000A of the Internal Revenue Code; grounds for imposing civil money penalties on persons who provide false or fraudulent information to the Exchange and on persons who improperly use or disclose information; updated standards for the consumer assistance programs; standards related to the opt-out provisions for self-funded, non-Federal governmental plans and the individual market provisions under the Health Insurance Portability and Accountability Act of 1996; standards for recognition of certain types of foreign group health coverage as minimum essential coverage; amendments to Exchange appeals standards and coverage enrollment and termination standards; and time-limited adjustments to the standards relating to the medical loss ratio program.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements contained in existing FDA regulations regarding the general administrative procedures for a person to petition the Commissioner of Food and Drugs (the Commissioner) to issue, amend, or revoke a rule; to file a petition for an administrative reconsideration or an administrative stay of action; and to request an advisory opinion from the Commissioner.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) for three-way, fixed-ratio combination drug Type A medicated articles containing chlortetracycline, sulfathiazole, and penicillin. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.

This notice makes the following corrections to the proposed rule that appeared in the February 26, 2014 Federal Register entitled ``Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements'': Corrects the preamble text and gap certification table for four certification criteria that were omitted from the list of certification criteria eligible for gap certification for the 2015 Edition EHR certification criteria; and provides information on inactive web links that appear in the proposed rule.

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and 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 70732-70814, provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Rule 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, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from WiMED, Inc. of its status as a PSO, and has delisted the PSO accordingly.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

This interim final rule with comment period implements changes to the payment adjustment for low-volume hospitals and to the Medicare- dependent hospital (MDH) program under the hospital inpatient prospective payment systems (IPPS) for FY 2014 (through March 31, 2014) in accordance with sections 1105 and 1106, respectively, of the Pathway for SGR Reform Act of 2013.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Humanitarian Device Exemption (HDE): Questions and Answers.'' This draft guidance answers commonly asked questions about humanitarian use devices (HUDs) and HDE applications. This guidance document reflects changes to the HDE program as a result of the Food and Drug Administration Safety and Innovation Act (FDASIA). This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioavailability and Bioequivalence Studies Submitted in NDAs or INDsGeneral Considerations'' (draft BA and BE guidance for NDAs). The draft guidance provides recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This draft guidance revises those parts of the March 2003 guidance entitled ``Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsGeneral Considerations'' relating to BA and BE studies for INDs, NDAs, and NDA supplements.

This document corrects technical errors in the final rules that appeared in the August 19, 2013 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Payment Policies Related to Patient Status.''