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

This notice announces the summer meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2014. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, and hospital outpatient therapeutic services supervision issues.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

This proposed rule amends the regulations relating to exclusion authorities under the authority of the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS or the Department). The proposed rule would incorporate statutory changes, propose early reinstatement procedures, and clarify existing regulatory provisions.

A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on June 19, 2013, Vol. 78, page 36788 and allowed 60 days for public comment. Three public comments, questions, and requests for information were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research, and issues recommendations. Task Force recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and stakeholders can consider when determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).

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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Margaret Beckwith, International Cancer Research Databank Branch, Office of Communications and Education, 9609 Medical Center Drive, MSC 9776, Bethesda, MD 20892-9776 or call non-toll-free number 240-376-6593 or Email your request, including your address to: mbeckwit@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: NCI Cancer Genetics Services Directory Web- Based Application and Update Mailer, 0925-0639, Date 08/31/2014, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Office of Communications and Education International Cancer Research Databank Branch has created the NCI Cancer Genetics Services Directory on NCI's Web site Cancer.gov. This directory is a searchable collection of information about professionals who provide services related to cancer genetics. These services include cancer risk assessment, genetic counseling, and genetic susceptibility testing. The professionals have applied to be in the directory using an online application form and have met basic criteria outlined on the form. There are currently 587 genetics professionals listed in the directory. Approximately 30-60 new professionals are added to the directory each year. The applicants are nurses, physicians, genetic counselors, and other professionals who provide services related to cancer genetics. The information collected on the application form includes name, professional qualifications, practice locations, and the area of specialization. The information is updated annually using a Web-based update mailer that mirrors the application form. The NCI Cancer Genetics Services Directory is a unique resource for cancer patients and their families who are looking for information about their family risk of cancer and genetic counseling. Collecting applicant information and verifying it annually by using the NCI Cancer Genetics Services Directory Web-based Application Form and Update Mailer is important for providing this information to the public and for keeping it current. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 180.

This proposed rule would update the hospice payment rates and the wage index for fiscal year (FY) 2015 and continue the phase out of the wage index budget neutrality adjustment factor (BNAF). This rule provides an update on hospice payment reform analyses and solicits comments on ``terminal illness'' and ``related conditions'' definitions, and on a process and appeals for Part D payment for drugs, while beneficiaries are under a hospice election. Also, this rule proposes timeframes for filing the notice of election and the notice of termination/revocation; adding the attending physician to the hospice election form; a requirement that hospices complete their hospice inpatient and aggregate cap determinations within 5 months after the cap year ends, and remit any overpayments; and updates for the hospice quality reporting program. In addition, this rule would provide guidance on determining hospice eligibility, information on the delay in the implementation of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), and would further clarify how hospices are to report diagnoses on hospice claims. Finally, the rule proposes to make a technical regulatory text change.

The Adminstration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements.'' This study will investigate the impact of price comparison information in direct-to-consumer (DTC) and health care professional advertising for prescription drugs.

This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2015 (for discharges occurring on or after October 1, 2014 and on or before September 30, 2015) as required by the statute. We are also proposing to collect data on the amount and mode (that is, Individual, Group, and Co-Treatment) of therapy provided in the IRF setting according to therapy discipline, revise the list of impairment group codes that presumptively meet the ``60 percent rule'' compliance criteria, provide for a new item on the Inpatient Rehabilitation Facility-Patient Assessment Instrument (IRF-PAI) form to indicate whether the prior treatment and severity requirements have been met for arthritis cases to presumptively meet the ``60 percent rule'' compliance criteria, and revise and update quality measures and reporting requirements under the IRF quality reporting program (QRP). In this proposed rule, we also address the implementation of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), for the IRF prospective payment system (PPS), effective when ICD-10-CM becomes the required medical data code set for use on Medicare claims and IRF-PAI submissions.

This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2015. In addition, it includes a proposal to adopt the most recent Office of Management and Budget (OMB) statistical area delineations to identify a facility's urban or rural status for the purpose of determining which set of rate tables would apply to the facility and to determine the SNF PPS wage index including a proposed one-year transition with a blended wage index for all providers for FY 2015. It also includes a discussion of the SNF therapy payment research currently underway within CMS. This proposed rule also proposes a revision to policies related to the Change of Therapy (COT) Other Medicare Required Assessment (OMRA). This proposed rule includes a discussion of a provision related to the Affordable Care Act involving Civil Money Penalties. Finally, this proposed rule includes a discussion of observed trends related to therapy utilization among SNF providers and a discussion of accelerating health information exchange in SNFs.