Notices. Final notice
6,136 words·~28 min read·
/register/2007/11/23/07-5801A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 6690-01-M FEDERAL COMMUNICATIONS COMMISSION [Report No. 2841] Petition for Reconsideration of Action in Rulemaking Proceeding November 14, 2007. A Petition for Reconsideration has been filed in the Commission's Rulemaking proceeding listed in this Public Notice and published pursuant to 47 CFR 1.429(e). The full text of this document is available for viewing and copying in Room CY-B402, 445 12th Street, SW., Washington, DC or may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc.
(BCPI)(1-800-378-3160). Oppositions to this petition must be filed by December 10, 2007. See Section 1.4(b)(1) of the Commission's rules (47 CFR 1.4(b)(1)). Replies to an opposition must be filed within 10 days after the time for filing oppositions have expired. *Subject:* In the Matter of Improving Public Safety Communications in the 800 MHz Band (WT Docket No. 02-55). Consolidating the 800 and 900 MHz Industrial/Land Transportation and Business Pool Channels. Amendment of Part 2 of the Commission's Rules Allocate Spectrum below 3 GHz for Mobile and Fixed Services to Support the Introduction of New Advanced Wireless Services, including Third Generation Wireless Systems (ET Docket No. 00-258). Petition for Rule Making of the Wireless Information Networks Forum Concerning the Unlicensed Personal Communications Service. Petition for Rule Making of UT Starcom, Inc., Concerning the Unlicensed Personal Communications Service. Amendment of Section 2.106 of the Commission's Rules to Allocate Spectrum at GHz for Use by the Mobile Satellite Service (ET Docket No. 95-18). *Number of Petitions Filed:* 1. Marlene H. Dortch, Secretary. [FR Doc. E7-22790 Filed 11-21-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than December 10, 2007. **A. Federal Reserve Bank of Cleveland** (Douglas A. Banks, Vice President) 1455 East Sixth Street, Cleveland, Ohio 44101-2566: *1. Jay L. Dunlap* , Lincoln, Nebraska; to retain voting shares of New Richmond Bancorporation, Inc., and thereby indirectly retain voting shares of River Hills Bank, National Association, both of New Richmond, Ohio. *2. Samad Yaltaghian* , Rushden, Northants, England; to acquire voting shares of New Richmond Bancorporation, Inc., and thereby indirectly acquire voting shares of River Hills Bank, National Association, both of New Richmond, Ohio. **B. Federal Reserve Bank of Minneapolis** (Jacqueline G. King, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291: *1. Richard Tucker Plumstead Revocable Trust, Richard Tucker Plumstead as trustee and individually; Richard Tucker Plumstead IRA; Vicki L. Turnquist Revocable Trust, Vicki L. Turnquist as trustee and individually; Vicki L. Turnquist IRA; and Vicki L. Turnquist Simplified Employee Pension Plan* , as a group acting in concert; to retain voting shares of Private Bancorporation, Inc., and thereby indirectly retain voting shares of Private Bank Minnesota, all of Minneapolis, Minnesota. Board of Governors of the Federal Reserve System, November 19, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-22848 Filed 11-21-07; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than December 20, 2007. **A. Federal Reserve Bank of Minneapolis** (Jacqueline G. King, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291: *1. Klein Financial, Inc.* , Chaska, Minnesota; to acquire 100 percent of the voting shares of First Community Bank, Savage, Minnesota. **B. Federal Reserve Bank of San Francisco** (Tracy Basinger, Director, Regional and Community Bank Group) 101 Market Street, San Francisco, California 94105-1579: *1. State Bancorp Northwest* ; to become a bank holding company by acquiring 100 percent of the voting shares of State Bank Northwest, both of Spokane Valley, Washington. Board of Governors of the Federal Reserve System, November 19, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc.E7-22847 Filed 11-21-07; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-08-0638] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Follow-up Survey of Chronic Fatigue Syndrome in Georgia—New—Coordinating Center for Infectious Diseases (CCID), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC is planning a follow-up study of chronic fatigue syndrome
(CFS)in metropolitan, urban and rural communities in Georgia. This is in response to Congressional recommendations that the Centers for Disease Control and Prevention
(CDC)utilize advanced surveillance methodologies for CFS to examine its natural history and identify risk factors and biomarkers. In 2004, OMB approved the information collection, Survey of Chronic Fatigue Syndrome and Chronic Unwellness in Georgia, under OMB Number 0920-0638, which provided baseline information on prolonged fatiguing illness in metropolitan, urban, and rural regions in Georgia. Data from the proposed Follow-up Study of Chronic Fatigue Syndrome in Georgia will be used to describe the clinical course of CFS and evaluate behavioral and biochemical factors associated with outcome. This follow-up study will also determine access to and utilization of health care by persons with CFS and measure direct and indirect economic burden due to the illness. As part of a control strategy, the information from this follow up study will be used in national and pilot regional provider education programs. The proposed study continues the Georgia survey using similar methodology and data collection instruments. This follow-up study begins with a detailed telephone interview to obtain additional data on participant health status during the last twelve month period. Eligible subjects will be asked to participate in clinical evaluations. There will be no cost to respondents other than their time. The estimated total annualized burden hours are 861. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden/ response (in hours) Follow-up Study Detailed Interview 2,870 1 18/60 Dated: November 15, 2007. Marilyn Radke, Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-22808 Filed 11-21-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-08-0566] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an e-mail to *omb@cdc.gov* . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Use of a Reader Response Postcard for Workers Notified of Results of Epidemiologic Studies Conducted by the National Institute for Occupational Safety and Health (NIOSH)—Reinstatement—The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description NIOSH, under Section 20(a)(1), (a)(4), (a)(7)(c), and Section 22 (d), (e)(5)(7) of the Occupational Safety and Health Act (29 U.S.C. 669), has the responsibility to “conduct (directly or by grants or contracts) research, experiments, and demonstrations relating to occupational safety and health, including studies of psychological factors involved, and relating to innovative methods, techniques, and approaches for dealing with occupational safety and health problems.” NIOSH also has the responsibility to “conduct special research, experiments, and demonstrations relating to occupational safety and health as are necessary to explore new problems, including those created by new technology in occupational safety and health [e.g., worker notification], which may require ameliorative action beyond that which is otherwise provided for in the operating provisions of the Act.” . Since 1977, the National Institute for Occupational Safety and Health (NIOSH) has been developing methods and materials for the notification of subjects of its epidemiological studies. NIOSH involvement in notifying workers of past exposures relates primarily to informing surviving cohort members of the findings of retrospective cohort studies conducted by NIOSH. Current policy within NIOSH is to notify subjects of the results of its epidemiologic studies. The extent of the notification effort depends upon the level of excess mortality or the extent of the disease or illness found in the cohort. Current notification efforts range from posting results at the facilities studied to mailing individual letter notifications to surviving cohort members and other stakeholders. The Industry-wide Studies Branch
(IWSB)of NIOSH, Division of Surveillance, Hazard Evaluation, and Field Studies (DSHEFS), usually conducts about two or three notifications per year, which typically require individual letters mailed to cohorts ranging in size from 200-20,000 workers each. In order to assess the effectiveness of the notification materials received by the recipients and to improve future communication of risk information, the evaluation instrument proposed was developed. The NIOSH Institute-wide Worker Notification Program routinely notifies subjects about the results of epidemiologic studies and the implications of the results. The overall purpose of the proposed project is to gain insight into the effectiveness of NIOSH worker notification in order to improve the quality and usefulness of the Institute's worker notification activities. Researchers from the NIOSH Division of Surveillance, Hazard Evaluations and Field Studies (DSHEFS) propose to provide notified workers with a Reader Response postcard for routinely assessing notified study subjects' responses to individual letter notification materials sent to them by NIOSH. We are requesting approval for three years. Participation is voluntary and there is no cost to respondents except for their time. The total estimated annualized burden hours are 1,333. Annualized Burden Table Form name Number of respondents Number of responses per respondent Average burden response (in hours) Total burden (in hours) Reader Response Card 8,000 1 10/60 1,333 Dated: November 15, 2007. Marilyn Radke, Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-22809 Filed 11-21-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-08-07AA] Proposed Data Collections Submitted for Public Comment and Recommendations 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 Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Pilot Project for a National Monitoring System for Major Adverse Effects of Medication Use During Pregnancy and Lactation—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description This data collection is based on the following components of the Public Health Service Act:
(1)Act 42 U.S.C. 241, Section 301, which authorizes “research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man.”
(2)42 U.S.C. 247b-4, Section 317 C, which authorizes the activities of the National Center on Birth Defects and Developmental Disabilities. This section was created by Public Law 106-310, also known as “the Children's Health Act of 2000.” This portion of the code has also been amended by Public Law 108-154, which is also known as the “Birth Defects and Developmental Disabilities Prevention Act of 2003”. The use of a number of medications during pregnancy is known to be associated with serious adverse effects in children. However, because pregnant and lactating women are traditionally excluded from clinical trials, and because pre-marketing animal studies do not necessarily predict the experience of humans, little information is available about the safety of most prescription medications during pregnancy and lactation at the time they are marketed. Nevertheless, many women inadvertently use medications early in gestation before realizing they are pregnant, and many maternal conditions require treatment during pregnancy and breastfeeding to safeguard the health of both mother and infant. Currently, the United States does not have a comprehensive early warning system for major adverse pregnancy or infant outcomes related to medication exposures. Teratology Information Services
(TIS)utilize trained specialists to provide free phone consultation, risk assessment, and counseling about exposures during pregnancy and breastfeeding—including medications—to women and healthcare providers. Altogether, they respond to approximately 70,000-100,000 inquiries each year in the United States and Canada. Because they have direct contact with pregnant and breastfeeding women, TIS are in a unique position to monitor the adverse effects of medication exposures during pregnancy and lactation. The objective of this project is to conduct a pilot study to assess whether TIS in the United States can serve as an effective monitoring and early warning system for major adverse effects on
(1)pregnancy outcomes (e.g., live birth, stillbirth, premature birth, low birth weight, etc.) and
(2)maternal and infant health. The project will assess the willingness of pregnant and breastfeeding women who contact a TIS about medication exposure to participate in and complete a follow-up study; whether these women are similar in demographic characteristics to the U.S. population of child-bearing age women; the specificity and completeness of the information obtained from such a study about adverse pregnancy outcomes, and maternal and infant health; and the amount of time required to conduct the follow-up. Within a continuous six-month period, three individual TIS will recruit all women who contact their service (up to a maximum of 250 enrollees per TIS) who have used any prescription or over-the-counter medication, vitamin, herbal, or other dietary supplement during pregnancy or while breastfeeding to participate in a follow-up study. Informed consent to participate will be obtained from each woman by telephone. For each pregnant woman who agrees to participate, the TIS will then conduct 4 telephone interviews: At enrollment; during the third trimester of pregnancy; approximately one month after delivery; and when the infant is about 3 months old. For each breastfeeding woman who agrees to participate, the TIS will then conduct 3 telephone interviews: At enrollment; approximately one month after enrollment; and 3 months after enrollment, if the woman is still taking medication and still breastfeeding. The interviews will assess maternal and fetal health throughout pregnancy, maternal and infant health at delivery, during the newborn and early infancy period, and while breastfeeding, and correlate these outcomes with medication exposure during pregnancy and while breastfeeding. There is no cost to respondents other than their time. Estimate of Annualized Burden Hours Type of respondent Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Pregnancy Exposure Group 338 5 23/60 648 Lactation Exposure Group 74 4 20/60 99 Pregnancy and Lactation Exposure Group (pregnant women who subsequently breastfeed) 338 5 30/60 845 Total 750 1,592 Dated: November 14, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-22811 Filed 11-21-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-2272-FN] Medicare and Medicaid Programs; Approval of the American Osteopathic Association's Deeming Authority for Critical Access Hospitals AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final notice. SUMMARY: This notice announces our decision to approve the American Osteopathic Association
(AOA)for recognition as a national accreditation program for critical access hospitals
(CAHs)seeking to participate in the Medicare or Medicaid programs. DATES: *Effective Date:* This final notice is effective December 28, 2007 through December 28, 2013. FOR FURTHER INFORMATION CONTACT: Cindy Melanson,
(410)786-0310. Patricia Chmielewski,
(410)786-6899. SUPPLEMENTARY INFORMATION: I. Background Under the Medicare program, eligible beneficiaries may receive covered services in a CAH provided certain requirements are met. Sections 1820(c)(2)(B) and 1861(mm) of the Social Security Act (the Act) establish distinct criteria for facilities seeking designation as a CAH. Under this authority, the minimum requirements that a CAH must meet to participate in Medicare are set forth in regulations at 42 CFR part 485, subpart F (Conditions of Participation: Critical Access Hospitals (CAHs)) which determine the basis and scope of CAH covered services. Conditions for Medicare payment for CAHs can be found at 42 CFR 413.70. Applicable regulations concerning provider agreements are at 42 CFR part 489 (Provider Agreements and Supplier Approval) and those pertaining to facility survey and certification are at part 488, subparts A and B. A. Verifying Medicare Conditions of Participation In general, we approve a CAH for participation in the Medicare program if it is participating as a hospital at the time it applies for CAH designation, and it is in compliance with parts 482 (Conditions of Participation for Hospitals) and 485, subpart F ( *Conditions of Participation:* Critical Access Hospital (CAHs)). For a CAH to enter into a provider agreement, a State survey agency must certify that the CAH is in compliance with the conditions or standards set forth in Section 1820 of the Social Security Act and part 485 of our regulations. Thereafter, the CAH is subject to ongoing review by a State survey agency to determine whether it continues to meet the Medicare requirements. There is, however, an alternative to State compliance surveys. Certification by a nationally-recognized accreditation program can substitute for ongoing State review. Section 1865(b)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accreditation organization that all applicable Medicare conditions are met or exceeded, we may “deem” those provider entities as having met the requirements. Accreditation by an accreditation organization is voluntary and is not required for Medicare participation. If an accreditation organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, a provider entity accredited by the national accrediting body's approved program may be deemed to meet the Medicare conditions. A national accreditation organization applying for approval of deeming authority under part 488, subpart A must provide us with reasonable assurance that the accreditation organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning re-approval of accrediting organizations are set forth at section § 488.4 and § 488.8(d)(3). The regulations at § 488.8(d)(3) require accreditation organizations to reapply for continued approval of deeming authority every six years, or sooner as we determine. The American Osteopathic Association's
(AOA)term of approval as a recognized accreditation program for CAHs expires December 27, 2007. II. Deeming Applications Approval Process Section 1865
(A)of the Act provides a statutory timetable to ensure that our review of deeming applications is conducted in a timely manner. The Act provides us with 210 calendar days after the date of receipt of an application to complete our survey activities and application review process. Within 60 days of receiving a completed application, we must publish a notice in the **Federal Register** that identifies the national accreditation body making the request, describes the request, and provides no less than a 30-day public comment period. At the end of the 210-day period, we must publish an approval or denial of the application. III. Proposed Notice On July 27, 2007, we published a proposed notice (72 FR 41331) announcing the AOA's request for re-approval as a deeming organization for CAHs. In the proposed notice, we detailed our evaluation criteria. Under section 1865(b)(2) of the Act and our regulations at § 488.4 (Application and reapplication procedures for accreditation organizations), we conducted a review of the AOA application in accordance with the criteria specified by our regulation, which include, but are not limited to the following: • An onsite administrative review of AOA's
(1)corporate policies;
(2)financial and human resources available to accomplish the proposed surveys;
(3)procedures for training, monitoring, and evaluation of its surveyors;
(4)ability to investigate and respond appropriately to complaints against accredited facilities; and
(5)survey review and decision-making process for accreditation; • A comparison of AOA's CAH accreditation standards to our current Medicare CAH conditions for participation; and, • A documentation review of AOA's survey processes to: • Determine the composition of the survey team, surveyor qualifications, and the ability of AOA to provide continuing surveyor training; • Compare AOA's processes to those of State survey agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities; • Evaluate AOA's procedures for monitoring providers or suppliers found to be out of compliance with AOA program requirements. The monitoring procedures are used only when the AOA identifies noncompliance. If noncompliance is identified through validation reviews, the survey agency monitors corrections as specified at § 488.7(d); • Assess AOA's ability to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner; • Establish AOA's ability to provide us with electronic data in ASCII-comparable code and reports necessary for effective validation and assessment of AOA's survey process; • Determine the adequacy of staff and other resources; • Review AOA's ability to provide adequate funding for performing required surveys; • Confirm AOA's policies with respect to whether surveys are announced or unannounced; and • Obtain AOA's agreement to provide us with a copy of the most current accreditation survey together with any other information related to the survey as we may require, including corrective action plans. In accordance with section 1865(b)(3)(A) of the Act, the July 27, 2007 proposed notice (72 FR 41331) also solicited public comments regarding whether AOA's requirements met or exceeded the Medicare conditions of participation for CAHs. We received no public comments in response to our proposed notice. IV. Provisions of the Final Notice A. Differences Between the AOA's Standards and Requirements for Accreditation and Medicare's Conditions and Survey Requirements We compared the standards contained in AOA's accreditation requirements for CAHs and its survey process in AOA's Application for Renewal of Deeming Authority for CAH Facilities with the Medicare CAH conditions for participation and our State Operations Manual. Our review and evaluation of AOA's deeming application, which were conducted as described in section III of this final notice, yielded the following: • AOA provided a list of trained surveyors that are able to provide consultative services to requesting facilities. In order to eliminate any real or perceived conflict of interest between the AOA's accreditation activities and AOA's list of surveyors able to provide consultation, AOA has formalized policies and procedures that adequately cover the conflict of interest process for surveyors that provide consultations; • AOA has revised its complaint policies to address timeframes for addressing complaints that involve immediate jeopardy; • AOA modified its application process for facilities undergoing a certification or recertification survey to allow fewer “black-out” dates to address CMS' concern of ensuring that surveys conducted by AOA comply with CMS' policy of unannounced surveys; • AOA formalized a process to ensure that all surveyors are receiving an annual performance evaluation; • AOA added standards to their CAH Manual to meet the requirements at § 485.603 rural health network, § 485.604 Personnel qualification, § 485.606 Designation and certification of CAHs, § 485.610 Status and location, and § 485.612 Compliance with hospital requirements at the time of application; • In order to meet the requirements at § 485.616(b), AOA added language to its standards to address agreements for credentialing and quality assurance requirements for CAHs that are members of a rural health network; • To meet the requirements at § 485.623(a), AOA revised its standard at 11.00.01 to address the requirement of adequate space for the provision of direct services; • To meet the requirements at § 485.623(d)(7), AOA revised its standards to address alcohol based hand rubs; • AOA revised its standards to address the supervision requirements for patients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, and physician assistants in order to meet the requirements at § 485.631(b)(1)(v) and § 485.631(b)(1)(vi); • In order to meet the requirements at § 485.635(a)(1), AOA added clarifying language to specify that health care services provided in the CAH are consistent with applicable State laws; • To meet the requirements of § 485.635(a)(2), AOA added language to its standard to address the requirement that policies are developed with at least one member of a group of professional personnel that is not a member of the CAH staff; • In order to meet the requirements of § 485.635(a)(3)(vii), AOA inserted language to address the requirements at § 483.25(i) with respect to inpatients receiving post-hospital skilled nursing facility
(SNF)care; • AOA revised its standard to include a representative sample of active and closed records in the periodic evaluation of its total program in order to meet the requirements at § 485.641(a)(1)(ii); • AOA added language to its standards to address the requirements at § 482.30(b)(1) through § 482.30(b)(3) regarding requirements for utilization review; • In order to meet the additional criteria in a distinct part unit of the CAH, the language addressed in the Medicare requirements § 412.25 Excluded hospital units: Common requirements and § 412.29 Excluded rehabilitation units: Additional requirements were adopted and added to AOA standards; • AOA added additional standards to meet the eligibility requirements for CAH distinct part units found at § 485.647; • Once AOA has implemented their revised standards, CMS will conduct a survey observation at the next available opportunity to validate proper application of the standards. • In order to meet the requirements of § 488.8(a)(2)(v), AOA has agreed to provide CMS with timely electronic data for effective validation and assessment of the organization's survey process; and • To comply with the Medicare requirements of conducting unannounced certification and recertification surveys, AOA revised its survey procedures to prohibit any advance mailings of surveyor materials to the facility prior to the survey and will not permit the hospital to mail back the surveyor findings to AOA after completion of the survey. B. Term of Approval Based on the review and observations described in section III of this final notice, we have determined that AOA's requirements for CAHs meet or exceed our requirements. Therefore, we approve the AOA as a national accreditation organization for CAHs that request participation in the Medicare program, effective December 28, 2007 through December 28, 2013. V. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). Authority: Section 1865 of the Social Security Act (42 U.S.C. 1395bb). (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare-Supplemental Medical Insurance Program) Dated: October 11, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-22628 Filed 11-21-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1377-N] Medicare Program; Listening Session on Hospital-Acquired Conditions and Present on Admission Indicator Reporting, December 17, 2007 AGENCY: Centers for Medicare & Medicaid Services, HHS. ACTION: Notice of meeting. SUMMARY: This notice announces a listening session being conducted as part of the selection of Hospital-Acquired Conditions
(HAC)and implementation of Present on Admission
(POA)Indicator Reporting, as authorized by section 5001(c) of the Deficit Reduction Act of 2005 (DRA). The purpose of this listening session is to solicit informal comments in preparation for the fiscal year 2009 inpatient prospective payment system
(IPPS)rulemaking process. Hospitals, hospital associations, representatives of consumer purchasers, payors of health care services, and all interested parties are invited to attend and make comments in person or in writing. It will also be possible to listen to the session by teleconference. However, because of time constraints, telephone participants will not be able to make verbal comments. Informal written comments will be accepted. This meeting is open to the public, but registration is required due to limited space and security requirements to enter the meeting location. This Listening Session is being held as a joint partnership between the Centers for Medicare & Medicaid Services and Centers for Disease Control and Prevention. DATES: *Meeting Date:* The listening session will be held on Monday, December 17, 2007 from 10 a.m. until 5 p.m., e.s.t. *Deadline for Meeting Registration and Submitting Requests for Special Accommodations:* Registration must be completed no later than 5 p.m., e.s.t. on Monday, December 10, 2007. Requests for special accommodations must be received no later than 5 p.m., e.s.t. on Monday, December 10, 2007. *Deadline for Presentations and Written Comments:* Written comments may be sent electronically to the address specified in the ADDRESSES section of this notice and must be received by 5 p.m., e.s.t. on Monday, December 31, 2007. ADDRESSES: *Meeting Location:* The meeting will be held in the main auditorium of the central building of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. *Registration and Special Accommodations:* Persons interested in attending the meeting or listening by teleconference must register by completing the on-line registration at *http://registration.intercall,com/go/cms2.* Individuals who need special accommodations should contact Colette Shatto
(410)786-6932, or via e-mail at *MFG@cms.hhs.gov.* *Written Comments or Statements:* Written comments may be sent by e-mail. Please e-mail comments to *hacpoa@cms.hhs.gov.* FOR FURTHER INFORMATION CONTACT: Further information regarding the December 17, 2007 listening session will be posted on the HAC & POA section of the CMS Web site at *http://www.cms.hhs.gov/HospitalAcqCond/01_Overview.asp.* You may also contact Colette Shatto, *MFG@cms.hhs.gov* , in the Medicare Feedback Group. Press inquiries are handled through the CMS Press Office at 202-690-6145. I. Background On February 8, 2006, the President signed the Deficit Reduction Act of 2005 (Pub. L. 109-171) (DRA). Section 5001(c) of the DRA requires the Secretary to identify, by October 1, 2007, at least two conditions that:
(1)Are high cost or high volume or both;
(2)result in the assignment of a case to a DRG that has a higher payment when present as a secondary diagnosis; and
(3)could reasonably have been prevented through the application of evidence-based guidelines. For discharges occurring on or after October 1, 2008, hospitals will not receive additional payment for cases in which one of the selected conditions occurring during hospitalization was not present on admission. That is, the case would be paid as though the secondary diagnosis was not present. Section 5001(c) of the DRA provides that we can revise the list of conditions from time to time, as long as it contains at least two conditions. In addition, CMS Change Request
(CR)5499 required hospitals to begin reporting the Present On Admission
(POA)indicator for all diagnoses on claims beginning October 1, 2007. II. Listening Session Format The December 17, 2007 listening session will begin at 10 a.m., e.s.t. with an overview of the objectives for the session and a presentation on Hospital Acquired Conditions
(HAC)and POA background. A brief overview regarding the implementation strategy for selecting the hospital-acquired conditions will then be presented. Next, a review of the conditions included in the FY 2008 hospital inpatient prospective payment systems
(IPPS)final rule with comment period will be presented followed by a public comment session. There will be a lunch break from approximately 1 to 2 p.m., e.s.t. Following lunch, there will be presentations on the following:
(1)The role of providers in documentation;
(2)POA Indicator Reporting; and
(3)HAC & POA Outreach and Education. An additional public comment period will follow the presentations. The meeting will conclude by 5 p.m., e.s.t. III. Registration Instructions For security reasons, any persons wishing to attend this meeting must register by the date listed in the DATES section of this notice. Persons interested in attending the meeting or listening by teleconference must register by completing the on-line registration located at *http://registration.intercall.com/go/cms2.* The on-line registration system will generate a confirmation page to indicate the completion of your registration. Please print this page as your registration receipt. Individuals may also participate in the listening session by teleconference. Registration is required as the number of call-in lines will be limited. The call-in number will be provided upon confirmation of registration. An audio download of the listening session will be available through the CMS HAC and POA Indicator Web site at *http://www.cms.hhs.gov/HospitalAcqCond/01_Overview.asp* after the listening session. IV. Security, Building, and Parking Guidelines This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. The on-site check-in for visitors will begin at 9 a.m., e.s.t. Please allow sufficient time to complete security checkpoints. Security measures include the following: • Presentation of government-issued photographic identification to the Federal Protective Service or Guard Service personnel. • Interior and exterior inspection of vehicles (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection. • Passing through a metal detector and inspection of items brought into the building. We note that all items brought to CMS, whether personal or for the purpose of demonstration or to support a demonstration, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 30 to 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Seating capacity is limited to the first 550 registrants. Authority: Section 5001(c) The Deficit Reduction Act
(DRA)of 2005. Dated: November 16, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 07-5801 Filed 11-21-07; 8:45 am]
Connectionstraces to 9
Traces to 9 documents
U.S. Code
10 references not yet in our index
- 47 CFR 1.429(e)
- 47 CFR 1.4(b)(1)
- 12 CFR 225
- Pub. L. 106-310
- Pub. L. 108-154
- 42 CFR 485
- 42 CFR 413.70
- 42 CFR 489
- 44 USC 35
- Pub. L. 109-171
Citation graph
cites case law
Notices
Final notice
Cite47 CFR 1.429(e)
Cite47 CFR 1.4(b)(1)
Cite12 CFR 225
Cites 19 · showing 12Cited by 0 across 0 sources