Department of Health and Human Services 2005 – Federal Register Recent Federal Regulation Documents

Results 301 - 350 of 3,480
Medicare Program; Electronic Submission of Medicare Claims
Document Number: 05-23080
Type: Rule
Date: 2005-11-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule adopts as final, and makes amendments to, the interim final rule published on August 15, 2003. That interim final rule implemented the statutory requirement that claims for reimbursement under the Medicare Program be submitted electronically as of October 16, 2003, except where waived. These regulations identify those circumstances for which mandatory submission of electronic claims to the Medicare Program is waived.
Federal Enforcement in Group and Individual Health Insurance Markets
Document Number: 05-23076
Type: Rule
Date: 2005-11-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Department of Health and Human Services (hhs)
This rule makes final an interim final rule that details procedures we use for enforcing title XXVII of the Public Health Service Act as added by the Health Insurance Portability and Accountability Act of 1996, and as amended by the Mental Health Parity Act of 1996, the Newborns' and Mothers' Health Protection Act of 1996, and the Women's Health and Cancer Rights Act of 1998. Specifically, we are responsible for enforcing title XXVII requirements in States that do not enact the legislation necessary to enforce those requirements, or otherwise fail to substantially enforce the requirements. We are also responsible for taking enforcement actions against non-Federal governmental plans. The regulation describes the process we use in both enforcement contexts. This final rule deletes an appendix to the interim rule that listed examples of violations of title XXVII and corrects the description of a cross-reference, but makes no substantive changes to the interim final rule.
Privacy Act of 1974; Report of a New System of Records
Document Number: 05-23239
Type: Notice
Date: 2005-11-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, we are proposing a new SOR titled, ``National Disaster Medical System (NDMS) Claims Processing System (CPS), No. 09-70-0572.'' CMS is responsible for establishing and administering a payment mechanism for definitive medical care provided under the National Disaster Medical System (NDMS) in accordance with section 2811 of the Public Health Service Act, 42 United States Code (U.S.C.) 300hh-11, a Memorandum of Agreement (MOA) entered into by the NDMS Partnersthe Departments of Homeland Security, Health and Human Services, Defense, and Veteran's Affairs, and an Inter-Agency Agreement between CMS and the Federal Emergency Management Agency (FEMA). Reimbursement to NDMS-participating hospitals (and practitioners furnishing medical services to NDMS- authorized patients during inpatient stays in those hospitals) for definitive medical care will be administered through the NDMS-CPS. The new system will collect data relating to individuals who receive NDMS- authorized medical treatment or services in NDMS hospitals for illness or injury resulting from a specified public health emergency or non- deferrable medical treatment or services to maintain health when such are temporarily not available as a result of the public health emergency. Data on individuals will be submitted by the Departments of Defense and Veteran's Affairs, staffed Federal Coordinating Centers activated by the NDMS, NDMS hospitals, and practitioners within NDMS hospitals that furnish medical treatment or services to NDMS patients. The primary purpose of the system is to justify and document payments for inpatient hospital and related practitioner services provided in connection to the NDMS. Information in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed by CMS and the NDMS Partners, contractors (including the NDMS claims contractor), and consultants contracted by the Agency; (2) support another Federal (including the NDMS Partners) agency of a state government, an agency established by state law, or its fiscal agent; (3) assist NDMS-participating hospitals (and practitioners within those hospitals) who have furnished services to individuals evacuated and placed by the NDMS; (4) assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs; (5) facilitate research on the quality and effectiveness of care provided, as well as payment-related projects; (6) support constituent requests made to a congressional representative; (7) support litigation involving the Agency, and (8) combat fraud and abuse in certain Federal health benefits programs. We have provided background information about the new system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 05-23202
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-23201
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-23200
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 05-23199
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 05-23198
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-23197
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-23196
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 05-23195
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 05-23194
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 05-23193
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 05-23192
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 05-23191
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institutes of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 05-23190
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 05-23189
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 05-23188
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 05-23155
Type: Notice
Date: 2005-11-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Organ Procurement and Transplantation Network
Document Number: 05-23149
Type: Proposed Rule
Date: 2005-11-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice sets forth the Secretary's proposal to include intestines within the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network. The Secretary further proposes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act, as amended.
Investigational New Drugs: Export Requirements for Unapproved New Drug Products
Document Number: 05-23120
Type: Rule
Date: 2005-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations on the exportation of investigational new drugs, including biological products. The final rule describes four different mechanisms for exporting an investigational new drug product. These provisions implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996 and also simplify the existing requirements for exports of investigational new drugs.
Invitation to Comment on Proposed Data Composites and Potential Performance Areas and Measures for the Child and Family Services Review
Document Number: 05-23206
Type: Notice
Date: 2005-11-22
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
2005 White House Conference on Aging
Document Number: 05-23103
Type: Notice
Date: 2005-11-22
Agency: Aging Administration, Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging (WHCoA) will have a conference call to finalize the resolutions and other items related to the 2005 WHCoA. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This notice is being published less than 15 days prior to the conference call due to scheduling problems.
Submission for OMB Review; Comment Request
Document Number: 05-23084
Type: Notice
Date: 2005-11-22
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: 05-23083
Type: Notice
Date: 2005-11-22
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: 05-23082
Type: Notice
Date: 2005-11-22
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: 05-23081
Type: Notice
Date: 2005-11-22
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Medicare Program; Hospice Care Amendments
Document Number: 05-23078
Type: Rule
Date: 2005-11-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule revises existing regulations that govern coverage and payment for hospice care under the Medicare program. These revisions reflect the statutory changes required by the Balanced Budget Act of 1997 (BBA), the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), and the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA). Additionally, these revisions reflect current policy on the documentation needed to support a certification of terminal illness, admission to Medicare hospice, and a new requirement that allows for discharges from hospice for cause under very limited circumstances. This final rule does not address the requirement for hospice data collection, the changes to the limitation of liability rules, or the changes to the hospice conditions of participation that were included in the BBA. The intent of this final rule is to expand the hospice benefit periods, improve documentation requirements to support certification and recertification of terminal illness, provide guidance on hospice admission procedures, clarify hospice discharge procedures, update coverage and payment requirements, and address the changing needs of beneficiaries, suppliers, and the Medicare program.
HIPAA Administrative Simplification: Standards for Electronic Health Care Claims Attachments; Extension of Comment Period
Document Number: 05-23077
Type: Proposed Rule
Date: 2005-11-22
Agency: Office of the Secretary, Department of Health and Human Services
This notice extends the comment period for a proposed rule published in the Federal Register on September 23, 2005 (70 FR 55990) that would recommend the adoption of a set of standards to facilitate the electronic exchange of clinical and administrative data to further improve the claims adjudication process when additional documentation is required. Due to the very technical nature of this rule, the industry is asking for additional time to conduct a more comprehensive and thorough review in order to provide comments to the Standards Development Organizations as well as to CMS. The comment period is extended for 60 days.
Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records (Edition 2); Availability
Document Number: 05-23062
Type: Rule
Date: 2005-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Questions and Answers Regarding Establishment and Maintenance of Records (Edition 2).'' The guidance responds to various questions raised about section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulation, which requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food. Persons covered by the regulation must be in compliance by December 9, 2005, June 9, 2006, or December 11, 2006, depending on the size of the business.
Advisory Commission on Childhood Vaccines; Notice of Meeting
Document Number: 05-23042
Type: Notice
Date: 2005-11-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006
Document Number: 05-23041
Type: Notice
Date: 2005-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA). Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing an opportunity for public comment on this collection of information. Since this collection received emergency approval that expires on January 1, 2006, FDA is following the normal PRA clearance procedures by issuing that notice.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006
Document Number: 05-23040
Type: Notice
Date: 2005-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
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 proposed collection of information associated with the guidance document entitled ``Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006.'' Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the Office of Management and Budget (OMB's) approval of this collection of information (OMB control number 0910-0571). Since this was an emergency approval that expires on January 1, 2006, FDA is following the normal PRA clearance procedures by issuing this notice.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Document Number: 05-23039
Type: Notice
Date: 2005-11-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Regulations For In Vivo Radiopharmaceuticals Used For Diagnosis and Monitoring'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Publication of OIG Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees
Document Number: 05-23038
Type: Notice
Date: 2005-11-22
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
OIG periodically develops and issues guidance, including Special Advisory Bulletins, to alert and inform the health care industry about potential problems or areas of special interest. This Federal Register notice sets forth the recently issued OIG Special Advisory Bulletin addressing patient assistance programs for Medicare Part D enrollees.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 05-23037
Type: Notice
Date: 2005-11-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Public Meeting of the President's Council on Bioethics on December 8-9, 2005
Document Number: 05-22990
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services
The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twenty-second meeting, at which, among other things, it will discuss ethical issues relating to children. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: Cloning, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, neuroscience, aging retardation, lifespan-extension, and organ procurement for transplantation. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005).
Fees for Sanitation Inspections of Cruise Ships
Document Number: 05-22967
Type: Notice
Date: 2005-11-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This notice announces an increase in the fees for vessel sanitation inspections for the remainder of fiscal year 2006 (January 1, 2006, through September 30, 2006).
Notice of Approval of Supplemental New Animal Drug Application; Ivermectin and Praziquantel Paste
Document Number: 05-22941
Type: Notice
Date: 2005-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for oral use of an ivermectin and praziquantel paste as an over-the-counter product for the treatment and control of various parasitic conditions of horses. This supplemental NADA reduces the minimum age for administration from 5 months to 2 months of age.
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-22940
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 05-22939
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 05-22938
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 05-22937
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 05-22936
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs; Florfenicol
Document Number: 05-22935
Type: Rule
Date: 2005-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for the use of florfenicol by veterinary feed directive in catfish feed for the control of mortality due to enteric septicemia of catfish.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 05-22934
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 05-22933
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 05-22932
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 05-22931
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 05-22930
Type: Notice
Date: 2005-11-21
Agency: Department of Health and Human Services, National Institutes of Health
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