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Code · REGISTER · 2007-09-28 · DEPARTMENT OF HEALTH AND HUMAN SERVICES · Notices

Notices. Notice

15,905 words·~72 min read·/register/2007/09/28/07-4773

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-0636] 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 State-based Evaluation of the Alert Notification Component of CDC's Epidemic Information Exchange (Epi-X) Secure Public Health Communications Network (OMB No. 0920-0636)—Extension—National Center for Health Marketing (NCHM), Centers for Disease Control and Prevention (CDC). Background and Brief Description A central component of the CDC's mission is to strengthen the nation's public health infrastructure by coordinating public health surveillance at CDC and providing domestic and international support through scientific communications and terrorism preparedness and emergency response. The Epidemic Information Exchange (Epi-X) provides CDC and its state and local partners and collaborators with a secure public health communications network intended for routine and emergent information exchange in a secure environment. Great attention has been focused on improving secure public health communications networks for the dissemination of critical disease outbreak and/or bioterrorism-related events, which may have multi-jurisdictional involvement and cause disease and death within a short time-frame. The purpose of the information gathered during this notification proficiency testing exercise is to evaluate the extent to which new registrants and currently authorized users of the Epidemic Information Exchange (Epi-X) are able to utilize alert notification functionality to minimize or prevent unnecessary injury or disease-related morbidity and mortality through the use of secure communications and rapid notification systems. In this case, notification alerts would be sent to targeted public health professionals through a ‘barrage' of office cell phone, home telephone, and pager calls to rapidly inform key health authorities from multidisciplinary backgrounds and multiple jurisdictions of evolving and critical public health information, and assist with the decision making process. Presently, the necessity of this evaluation process is timely because of ongoing terrorism threats and acts perpetrated worldwide. The survey information will be gathered through an online questionnaire format, and help evaluate user comprehension and facility solely with the targeted notification and rapid alerting functionalities of Epi-X. The questionnaire will consist of both closed- and open-ended items, and will be administered through Zoomerang, an online questionnaire program, or as a last resort, by telephone. Approximately 2,000 Epi-X users from every state of the union will be asked to volunteer input (in a 5-10 question format) about their experiences using the alert notification functionalities of the Epi-X communications system. There will be no cost to respondents, whose participation will be strictly voluntary. The total estimated burden hours are 167. Estimated Annualized Burden Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Public Health Professionals 1,000 1 10/60 Dated: September 24, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-19198 Filed 9-27-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-07BR] 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 project or to obtain a copy of data collection plans and instruments, call the CDC Reports Clearance Officer on 404-639-5960 or send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS D-74, 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 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 National Survey of Residential Care Facilities (NSRCF) 2008-2010—New—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). Background and Brief Description Section 306 of the Public Health Service
(PHS)Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, shall collect statistics on the extent and nature of illness and disability of the population of the United States. The National Survey of Residential Care Facilities (NSRCF) is a new collection. It is designed to complement data collected by other federal surveys and to fill a significant data gap about a major portion of the long-term care population. Data from the NSRCF will provide a database on residential care facilities that researchers and policymakers can use to address a wide array of research and policy questions. The survey will utilize a computer-assisted personal interviewing
(CAPI)system to collect information about facility and resident characteristics. This computerized system speeds the flow of data making it possible to release information on a more timely basis and makes it easier for respondents to participate in the survey. A stratified random sample of residential care facilities across four strata (small, medium, large and extra large) will be selected to participate in the NSRCF. Within each facility a random sample of residents will be selected. To be eligible a facility must have four or more beds, be licensed, certified, or registered and provide or arrange for 24 hour supervision and personal care services for residents. The facility questionnaire will collect data about facility characteristics (size, age, types of rooms), services offered, characteristics of the resident population, facility policies and services, costs of services, and background of the administrator. The Resident Questionnaire collects information on resident demographics, current living arrangements within the facility, involvement in activities, use of services, charges for care, health status, and cognitive and physical functioning. In the pretest, 25 facility administrators, and 25 facility staff serving as respondents will be interviewed on an annualized basis. Residents themselves will not be interviewed. For the national survey, approximately 2,250 facilities will be surveyed for an annual average of 750. Information on 5 residents each will be collected from an annual average of 750 facility staff. Users of NSRCF data include, but are not limited to the CDC; the Congressional Research Office; the Bureau of Health Professions, Health Resources and Services Administration; the Office of the Assistant Secretary for Planning and Evaluation (ASPE); the Agency for Healthcare Research and Quality; the American Association of Homes and Services for the Aging; the National Hospice and Palliative Care Organization; American Health Care Association, Centers for Medicare and Medicaid Services (CMS), Bureau of the Census; and AARP. Other users of these data include universities, contract research organizations, many in the private sector, foundations, and a variety of users in the print media. There is no cost to respondents other than their time to participate. Estimated Annualized Burden Hours Type of respondent Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Facility Administrator (pretest) 25 1 1 25 Facility Staff (pretest) 25 5 30/60 63 Facility Administrator 750 1 1 750 Facility Staff 750 5 30/60 1,875 Total 2,713 Dated: September 24, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Office of the Chief Science Officer, Centers for Disease Control and Prevention. [FR Doc. E7-19200 Filed 9-27-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-312] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Conflict of Interest and Ownership and Control Information; *Use:* The Conflict of Interest and Ownership and Control Information Statement (COI Statement) is sent to all Medicare Fiscal Intermediaries
(FIs)and Carriers to collect full and complete information on any entity's or individual's ownership interest (defined as a 5 per centum or more) in an organization that may present a potential conflict of interest in their role as a Medicare FI or Carrier. The information gathered in the survey is used to ensure that all potential, apparent and actual conflicts of interest involving Medicare contractors are appropriately mitigated and that employees of the contractors, including officers, directors, trustees and members of their immediate families, do not utilize their positions with the contractor for their own private business interest to the detriment of the Medicare program. Information is also requested on potential organizational conflicts of interest involving Medicare contractors' ownership of other entities in the health care industry. If a response has indicated that a potential conflict of interest exists, the contractor is contacted and asked to address how the conflict can be avoided or mitigated. *Form Number:* CMS-R-312 (OMB#: 0938-0795); *Frequency:* Reporting—Annually; *Affected Public:* Private Sector—Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 37; *Total Annual Responses:* 37; *Total Annual Hours:* 11,100. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on
(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:
(202)395-6974. Dated: September 21, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-19247 Filed 9-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-2267-N] Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice announces that laboratories located in and licensed by the State of Washington that possess a valid license under the Medical Test Site Licensure Law, Chapter 70.42 of the Revised Code of Washington, are exempt from the requirements of the Clinical Laboratory Improvement Amendments of 1988 until September 28, 2013. EFFECTIVE DATES: The exemption granted by the notice is effective until September 28, 2013. FOR FURTHER INFORMATION CONTACT: Sandra Farragut (410)786-3531. SUPPLEMENTARY INFORMATION: I. Background Section 353 of the Public Health Service Act (PHSA), as amended by the Clinical Laboratory Improvement Amendments of 1988
(CLIA)(Pub. L. 100-578) enacted on October 31, 1988, generally provides that no laboratory may perform tests on human specimens for the diagnosis, prevention or treatment of any disease or impairment of, or assessment of the health of human beings unless it has a certificate to perform that category of tests issued by the Secretary of the Department of Health and Human Services (HHS). Under section 1861(s) of the Social Security Act (the Act), the Medicare program will only pay for laboratory services if the laboratory has a CLIA certificate. Section 1902(a)(9)(C) of the Act requires that State Medicaid plans pay only for laboratory services furnished by CLIA-certified laboratories. Thus, although subject to specified exemptions and exceptions, laboratories generally must have a current and valid CLIA certificate to test human specimens for medical purposes noted above to be eligible for payment for those tests from the Medicare or Medicaid programs. Regulations implementing section 353 of the PHS Act are contained in 42 CFR part 493. Section 353(p) of the PHS Act provides for the exemption of laboratories from CLIA requirements in States that enact legal requirements that are equal to or more stringent than CLIA's statutory and regulatory requirements. Section 353(p) of the PHS Act is implemented in subpart E of regulations at 42 CFR part 493. Sections 493.551 and 493.553 provide that we may exempt from CLIA requirements, for a period not to exceed 6 years, all State licensed or approved laboratories in a State if the State Licensure Program meets the specified conditions. Section 493.559 provides that we will publish a notice in the **Federal Register** when we grant exemption to an approved State laboratory licensure program. It also provides that the notice will include the following: • The basis for granting the exemption. • A description of how the laboratory requirements are equal to or more stringent than those of CLIA. • The term of approval, not to exceed 6 years. State of Washington's Application for CLIA Exemption of Its Laboratories The State of Washington has applied for exemption of its laboratories from CLIA program requirements. The State of Washington submitted all of the applicable information and attestations required by § 493.551, § 493.553, and § 493.557 for State licensure programs seeking exemption of their licensed laboratories from CLIA program requirements. Examples of documents and information submitted are: A comparison of its laboratory licensure requirements with comparable CLIA condition-level requirements (that is, a crosswalk); a description of its inspection process; proficiency testing monitoring process; its data management and analysis system; its investigative and response procedures for complaints received against laboratories; and its policy regarding announcement and unannouncement of inspections. CMS Analysis of Washington's Application and Supporting Documentation In order to determine whether we should grant a CLIA exemption to laboratories licensed by a State, we review the application and additional documentation that the State submits to CMS and conduct a detailed and in-depth comparison of State licensure program and CLIA requirements to determine whether the State program meets the requirements at subpart E of part 493. In summary, the State generally must demonstrate that its State licensure program meets the following requirements: • Have State laws in effect that provide for laboratory requirements that are equal to or more stringent than CLIA condition-level requirements for laboratories. • Have a State licensure program with requirements that are equal to or more stringent than the CLIA condition-level requirements such that the State program licenses laboratory would meet the CLIA condition-level requirements if it were inspected against those requirements. • Is shown to meet the requirements of § 493.553, § 493.555, and § 493.557(b) and is approved by CMS under § 493.551. For example, among other things, programs would need to: —Demonstrate that it has enforcement authority and administrative structures and resources adequate to enforce its laboratory requirements. —Permit CMS or CMS agents to inspect laboratories within the State. —Require laboratories within the State to submit to inspections by CMS or CMS agents as a condition of licensure. —Agree to pay the cost of the validation program administered by CMS and the cost of the State's pro rata share of the general overhead to develop and implement CLIA as specified in § 493.645(a), § 493.646(b), and § 493.557(b). —Take appropriate enforcement action against laboratories found by CMS or CMS agents not to be in compliance with requirements comparable to condition-level requirements, as specified in § 493.557(b). As specified in our regulations at § 493.555 and § 493.557(b), our review of a State laboratory program includes (but is not necessarily limited to) an evaluation of the following: • Whether the State's requirements for laboratories are equal to or more stringent than the CLIA condition-level requirements. • The State's inspection process requirements to determine the following: —The comparability of the full inspection and complaint inspection procedures to those of CMS. —The State's enforcement procedures for laboratories found to be out of compliance with its requirements. —The ability of the State to provide CMS with electronic data and reports with the adverse or corrective actions resulting from proficiency testing
(PT)results that constitute unsuccessful participation in CMS-approved PT programs and with other data we determine to be necessary for validation review and assessment of the State's inspection process requirements. • The State's agreement with CMS to ensure that the agreement obligates the State to do the following: —Notify CMS within 30 days of the action taken against any CLIA-exempt laboratory that has had its licensure or approval withdrawn or revoked or been in any way sanctioned. —Notify CMS within 10 days of any deficiency identified in a CLIA-exempt laboratory in cases when the deficiency poses an immediate jeopardy to the laboratory's patients or a hazard to the general public. —Notify each laboratory licensed by the State within 10 days of CMS' withdrawal of the exemption. —Provide CMS with written notification of any changes in its licensure (or approval) and inspection requirements. —Disclose to CMS or a CMS agent any laboratory's PT results in accordance with a State's confidentiality requirements. —Take the appropriate enforcement action against laboratories found by CMS not to be in compliance with CLIA condition-level requirements in a validation survey and report these enforcement actions to CMS. —Notify CMS of all newly licensed laboratories, including changes in the specialties and subspecialties for which any laboratory performs testing, within 30 days. —Provide CMS, as requested, inspection schedules for validation purposes. In keeping with the process described above, we evaluated the application and supporting materials that were submitted by Washington State to verify that the laboratories licensed through their program will meet or exceed the requirements of the following subparts of part 493: Subpart H, Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing; Subpart J, Facility Administration for Nonwaived Testing; Subpart K, Quality Systems for Nonwaived Testing, Subpart M, Personnel for Nonwaived Testing; Subpart Q, Inspection; and Subpart R, Enforcement Procedures. We found that Washington State's laboratory licensure program requirements mapped to all the CLIA condition-level requirements. Its licensure program's inspection process and proficiency testing monitoring processes were adequate. Other materials that were submitted demonstrated compliance with the other above-referenced requirements of subpart E of Part 493. As a result, CMS concluded that the submitted documents supported exempting laboratories licensed under that program from the CLIA program requirements. Furthermore, a review of CMS' validation inspections conducted by the CMS office in Seattle, Washington, supported the conclusion. The Federal validation inspections of CLIA-exempt laboratories, as specified in § 493.563, were conducted on a representative sample basis as well as in response to any substantial allegations of noncompliance (complaint inspections). The outcome of those validation inspections has been and will continue to be CMS' principal tool for verifying that the laboratories located in and licensed by the State are in compliance with CLIA requirements. The CMS Regional Office in Seattle, Washington has conducted validation inspections of a representative sample (approximately 5 percent) of the laboratories inspected by the Washington State Office of Laboratory Quality Assurance (LQA). The validation inspections were primarily of the concurrent type; that is, CMS surveyors accompanied Washington State's inspectors, each inspecting against his or her agency's respective regulations. Analysis of the validation data revealed no significant differences between the State and Federal findings. The validation surveys verified that the State of Washington inspection process covers all CLIA conditions applicable to each laboratory being inspected, and also verified that the State laboratory licensure requirements meet or exceed CLIA condition-level requirements. The CMS validation surveys found the State inspectors highly skilled and qualified. The LQA inspected laboratories in timely fashion, that is, all laboratories were inspected within the required 24-month cycle. All parameters monitored by CMS' Seattle office to date indicate that the State of Washington is meeting all requirements for approval of CLIA exemption. This Federal monitoring will continue as an on-going process. Conclusion Based on review of the documents submitted by the Washington State laboratory licensure program pursuant to the requirements of subpart E of part 493, as well as the outcome of the validation inspections conducted by the CMS regional office in Seattle, we find that the Washington State laboratory licensure program meets the requirements of 42 CFR § 493.551(a), and that as a result, we may exempt from CLIA program requirements all State licensed or approved laboratories. Approval of the CLIA exemption for laboratories located in and licensed by the State of Washington is subject to removal if we determine that the outcome of a comparability review or a validation review inspection is not acceptable, as described under § 493.573 and § 493.575, or if the State of Washington fails to pay the required fee every 2 years as required under § 493.646. Laboratory Data In accordance with our regulations at § 493.557(b)(8), the State of Washington will continue to agree to provide us with changes to a laboratory's specialties or subspecialties based on the State's survey. The State of Washington also will provide us with changes in a laboratory's certification status, such as a change from a regular certificate to a certificate of waiver. Required Administrative Actions CLIA is a user-fee funded program. The registration fee paid by laboratories is intended to cover the cost of the development and administration of the program. However, when a State's application for exemption is approved, we do not charge a fee to laboratories in the State. The State's share of the costs associated with CLIA must be collected from the State, as specified in § 493.645. The State of Washington must pay for the following: • Costs of Federal inspection of laboratories in the State to verify that Washington State's laboratory licensure program requirements are enforced in an appropriate manner. The average Federal hourly rate is multiplied by the total hours required to perform Federal validation surveys within the State. • Costs incurred for Federal investigations and surveys triggered by complaints that are substantiated. We will bill the State of Washington on a semiannual basis. • The State of Washington's proportionate share of the costs associated with establishing, maintaining, and improving the CLIA computer system, a portion of those services from which the State of Washington received direct benefit or contributed to the CLIA program in the State. Thus, the State of Washington is being charged for a portion of CMS' direct and indirect costs as well as a portion of the costs incurred by the Centers for Disease Control and Prevention
(CDC)and the Food and Drug Administration (FDA). In order to estimate the State of Washington's proportionate share of the general overhead costs to develop and implement CLIA, we determined the ratio of laboratories in the State to the total number of laboratories nationally. Approximately 1.5 percent of the registered laboratories are in the State of Washington. We determined that a corresponding percentage of the applicable CDC, FDA, and CMS costs should be borne by the State of Washington. The State of Washington has agreed to pay us the State's pro rata share of the overhead costs and anticipated costs of actual validation and complaint investigation surveys. A final reconciliation for all laboratories and all expenses will be made. We will reimburse the State for any overpayment or bill it for any balance. II. Approval In light of the foregoing, CMS grants approval of the State of Washington's laboratory licensure program under Subpart E. All laboratories located in and licensed by the State of Washington under the Medical Test Site Licensure Law, Chapter 70.42 of the Revised Code of Washington, are CLIA-exempt for all specialties and subspecialties until September 28, 2013. Authority: Section 353(p) of the Public Health Service Act (42 U.S.C. 263a). Dated: July 20, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-18731 Filed 9-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Notice of Hearing: Reconsideration of Disapproval of Pennsylvania State Plan Amendment
(SPA)06-007 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of Hearing. SUMMARY: This notice announces an administrative hearing to be held on November 16, 2007, at Suite 216, The Public Ledger Building, 150 S. Independence Mall West, Conference Room 241, the Pennsylvania Room, Philadelphia, PA 19106, to reconsider CMS's decision to disapprove Pennsylvania SPA 06-007. *Closing Date:* Requests to participate in the hearing as a party must be received by the presiding officer by October 15, 2007. FOR FURTHER INFORMATION CONTACT: Kathleen Scully-Hayes, Presiding Officer, CMS, Lord Baltimore Drive, Mail Stop LB-23-20, Baltimore, MD 21244. Telephone:
(410)786-2055 SUPPLEMENTARY INFORMATION: This notice announces an administrative hearing to reconsider CMS's decision to disapprove Pennsylvania State plan amendment
(SPA)06-007 which was submitted on September 27, 2006. This SPA was disapproved on June 29, 2007. Under this SPA, the State requested the addition of targeted case management services to low-income, first-time expectant mothers who have, or are at risk of having, a high incidence of medical or social problems. The new targeted case management services were to be provided through the Nurse Family Partnership Program. CMS made a Request for Additional Information on December 22, 2006, to which the State responded on April 2, 2007. The information provided confirmed that the targeted case management services proposed in SPA 06-007 are currently provided to all individuals without charge. The amendment was disapproved because CMS found that the amendment violated the statute for reasons set forth in the disapproval letter. CMS consulted with the Secretary as required by Federal regulations at 42 CFR 430.15(c)(2). Section 1902(a)(10) of the Social Security Act (the Act) requires that States make available medical assistance which is defined at section 1905(a) of the Act, and is limited to payment of medical costs for “individuals whose income and resources are insufficient to meet all of such costs.” The term “medical assistance” fundamentally excludes payment for medical services that are free to the general public, since where a service is provided without charge the individual is not in the circumstance of having insufficient income or resources to meet the cost of care. Hence, such services do not meet the definition of “medical assistance.” In addition, section 1902(a)(30) of the Act requires States to have methods and procedures in place to assure that payments are consistent with efficiency, economy, and quality of care. CMS did not find that Medicaid payments for case management for first-time expectant mothers were consistent with this requirement when these same services are available to non-Medicaid enrollees without charge. Furthermore, the State failed to provide documentation requested by CMS demonstrating that the rate methodology used to determine payments to service providers was consistent with section 1902(a)(30). The State also failed to provide documentation of the various cost elements used to determine a fee-schedule amount or to submit provider surveys conducted by the State to determine whether its proposed indirect cost rate should be applied to direct costs to calculate the final fee paid to providers. Based on the above, and after consultation with the Secretary of the Department of Health and Human Services as required under Federal regulations at 42 CFR 430.15(c)(2), CMS disapproved Pennsylvania Medicaid SPA 06-007. The issues to be decided at the hearing are: • Whether Pennsylvania has demonstrated that its SPA 06-007 complies with sections 1902(a)(10) and 1902(a)(30) of the Act by limiting payment of medical assistance to payment of medical costs for individuals who lack sufficient income and resources to meet the cost of care; and • Whether the State has provided adequate documentation to demonstrate that the State's rate methodology is consistent with the requirements of section 1902(a)(30) of the Act; specifically whether the rates paid to service providers are consistent with efficiency, economy, and quality of care. Section 1116 of the Act and Federal regulations at 42 CFR Part 430, establish Department procedures that provide an administrative hearing for reconsideration of a disapproval of a State plan or plan amendment. CMS is required to publish a copy of the notice to a State Medicaid agency that informs the agency of the time and place of the hearing, and the issues to be considered. If we subsequently notify the agency of additional issues that will be considered at the hearing, we will also publish that notice. Any individual or group that wants to participate in the hearing as a party must petition the presiding officer within 15 days after publication of this notice, in accordance with the requirements contained at 42 CFR 430.76(b)(2). Any interested person or organization that wants to participate as amicus curiae must petition the presiding officer before the hearing begins in accordance with the requirements contained at 42 CFR 430.76(c). If the hearing is later rescheduled, the presiding officer will notify all participants. The notice to Pennsylvania announcing an administrative hearing to reconsider the disapproval of its SPA reads as follows: Ms. Estelle B. Richman, Secretary of Public Welfare, Commonwealth of Pennsylvania, Department of Public Welfare, Office of Medical Assistance Programs, Bureau of Policy, Budget and Planning, P.O. Box 8046, Harrisburg, PA 17105. Dear Ms. Richman: I am responding to your request for reconsideration of the decision to disapprove Pennsylvania State plan amendment
(SPA)06-007, which was submitted on September 27, 2006, and disapproved on June 29, 2007. Under this SPA, the State requested the addition of targeted case management services for first-time, low-income expectant mothers who have, or are at risk of having, a high incidence of medical or social problems. The Centers for Medicare & Medicaid Services
(CMS)disapproved the SPA because CMS found that it violated the statute for reasons set forth in the disapproval letter. The CMS made a Request for Additional Information on December 22, 2006, to which the State responded on April 2, 2007. The information provided confirmed that the targeted case management services proposed in SPA 06-007 are currently provided to first-time expectant mothers without charge through State grant funding and private funds. Section 1902(a)(10) of the Social Security Act (the Act) requires that States make available medical assistance, which is defined at section 1905(a) of the Act, and is limited to payment of medical costs for “individuals whose income and resources are insufficient to meet all of such costs.” The term “medical assistance” fundamentally excludes payment for medical services that are free to the general public, since where a service is provided without charge the individual is not in the circumstance of having insufficient income or resources to meet the cost of care. Hence, such services do not meet the definition of “medical assistance.” In addition, section 1902(a)(30) of the Act requires States to have methods and procedures in place to assure that payments are consistent with efficiency, economy, and quality of care. CMS did not find that Medicaid payments for case management for first-time expectant mothers were consistent with this requirement when these same services are available to non-Medicaid enrollees without charge. Furthermore, the State failed to provide documentation requested by CMS demonstrating that the rate methodology used to determine payments to service providers was consistent with section 1902(a)(30). The State failed to provide documentation of the various cost elements used to determine a fee-schedule amount or to submit provider surveys conducted by the State to determine whether its proposed indirect cost rate should be applied to direct costs to calculate the final fee paid to providers. Based on the above, and after consultation with the Secretary of the Department of Health and Human Services as required under Federal regulations at 42 CFR 430.15(c)(2), CMS disapproved Pennsylvania Medicaid SPA 06-007. The issues to be decided at the hearing are • Whether Pennsylvania has demonstrated that its SPA 06-007 complies with sections 1902(a)(10) and 1902(a)(30) of the Act by limiting payment of medical assistance to payment of medical costs for individuals who lack sufficient income and resources to meet the cost of care; and • Whether the State has provided adequate documentation to demonstrate that the State's rate methodology is consistent with the requirements of section 1902(a)(30) of the Act; specifically whether the rates paid to service providers are consistent with efficiency, economy, and quality of care. I am scheduling a hearing on your request for reconsideration to be held on November 16, 2007, at Suite 216, The Public Ledger Building, 150 S. Independence Mall West, Conference Room 241, the Pennsylvania Room, Philadelphia, PA 19106, to reconsider the decision to disapprove SPA 06-007. If this date is not acceptable, we would be glad to set another date that is mutually agreeable to the parties. The hearing will be governed by the procedures prescribed by Federal regulations at 42 CFR Part 430. I am designating Ms. Kathleen Scully-Hayes as the presiding officer. If these arrangements present any problems, please contact the presiding officer at
(410)786-2055. In order to facilitate any communication which may be necessary between the parties to the hearing, please notify the presiding officer to indicate acceptability of the hearing date that has been scheduled and provide names of the individuals who will represent the State at the hearing. Sincerely, Kerry Weems, *Acting Administrator.* Section 1116 of the Social Security Act (42 U.S.C. 1316; 42 CFR 430.18) (Catalog of Federal Domestic Assistance Program No. 13.714, Medicaid Assistance Program.) Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-19141 Filed 9-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-3186-PN] Medicare and Medicaid Programs; Application by the Indian Health Service
(IHS)for Continued Recognition as a National Accreditation Organization for Accrediting American Indian and Alaska Native Entities To Furnish Outpatient Diabetes Self-Management Training AGENCY: Centers for Medicare and Medicaid Services, HHS. ACTION: Proposed notice. SUMMARY: This proposed notice announces the receipt of an application from the Indian Health Service for continued recognition as a national accreditation organization for accrediting American Indian and Alaska Native entities that wish to furnish outpatient diabetes self-management training to Medicare beneficiaries. This notice also announces a 30-day public comment period. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. October 29, 2007. ADDRESSES: In commenting, please refer to file code CMS-3186-PN. Because of staff and resource limitations, we cannot accept comments by facsimile
(FAX)transmission. You may submit comments in one of four ways (no duplicates, please): 1. *Electronically.* You may submit electronic comments on specific issues in this regulation to *http://www.cms.hhs.gov/eRulemaking* . Click on the link “Submit electronic comments on CMS regulations with an open comment period.” (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.) 2. *By regular mail* . You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3186-PN, P.O. Box 3014, Baltimore, MD 21244-1850. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail* . You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, *Attention:* CMS-3186-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. *By hand or courier.* If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number
(410)786-9994 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Eva Fung,
(410)786-7539. SUPPLEMENTARY INFORMATION: *Submitting Comments:* We welcome comments from the public on all issues set forth in this proposed notice to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS-3186-PN and the specific “issue identifier” that precedes the section on which you choose to comment. *Inspection of Public Comments:* All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *http://www.cms.hhs.gov/eRulemaking.* Click on the link “Electronic Comments on CMS Regulations” on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background Under the Medicare program, eligible beneficiaries may receive outpatient diabetes self-management training when ordered by the physician or qualified nonphysician practitioner treating the beneficiary's diabetes, provided certain requirements are met. We sometimes use national accreditation organizations to determine whether a provider entity meets the Medicare requirements that are necessary in order for an entity to provide a service covered by Medicare. Section 1865(b)(1) of the Social Security Act (the Act), provides that a national accreditation organization must have an agreement in effect with the Secretary and meet the standards and requirements as specified in 42 CFR part 410, subpart H. The regulations pertaining to application procedures for national accreditation organizations for diabetes self-management training services are specified in § 410.142 (CMS process for approving national accreditation organizations). A national accreditation organization applying for deeming authority must provide us with reasonable assurance that it requires accredited entities to meet requirements that are at least as stringent as those set forth by CMS. Nonprofit or not-for-profit organizations with demonstrated experience in representing the interests of individuals with diabetes are eligible to request recognition as a national accreditation organization. The national accreditation organization, after being approved and recognized by CMS, evaluates the entity to determine if it meets one of the sets of quality standards as specified in § 410.144 (Quality standards for deemed entities). If the national accreditation organization finds that the entity meets or exceeds applicable requirements, the Secretary shall deem the entity as meeting the Medicare requirements. Section 1865(b)(2) of the Act requires that the Secretary's findings relative to approving a national accreditation organization as a deeming authority consider the organization's requirements for accreditation, its survey procedures, its ability to provide adequate resources for conducting required surveys and its ability to supply information for use in enforcement activities, its monitoring procedures for entities found out of compliance with the conditions or requirements, and its ability to provide the Secretary with necessary data for validation. The Secretary evaluates the national accreditation organization's accreditation requirements to determine if they meet or exceed the Medicare conditions as we would have applied them. Section 1865(b)(3)(A) of the Act requires that the Secretary publish within 60 days of receipt of a completed application, a notice identifying the national accreditation body making the request, describing the nature of the request, and providing at least a 30-day public comment period. In addition, the Secretary has 210 days from receipt of the request to publish a finding of approval or denial of the application. If the Secretary recognizes an accreditation organization in this manner, once an entity that furnishes diabetes training is accredited by a national accreditation organization, it can be “deemed” to meet the Medicare conditions of coverage for diabetes self-management training. II. Provisions of the Proposed Notice [If you choose to comment on issues in this section, please include the caption “PROVISIONS OF THE PROPOSED NOTICE” at the beginning of your comments.] The purpose of this notice is to notify the public of the Indian Health Service's (IHS's) request for the approval for continued recognition as a national accrediting organization for accreditation of American Indian and Alaska Native entities to furnish outpatient diabetes self-management training services. The IHS proposes to continue to adopt the National Standards for Diabetes Self-Management Education as its quality standards. This notice also solicits public comments on the ability of the IHS to develop and apply its standards to entities furnishing outpatient diabetes self-management training services. Outpatient Diabetes Self-Management Training Services The regulations specifying the Medicare conditions for coverage for outpatient diabetes self-management training services are specified in 42 CFR parts 410, subpart H. These conditions implement section 1861(qq) of the Act, which provides for Medicare Part B coverage of outpatient diabetes self-management training services specified by the Secretary. Under section 1865(b)(2) of the Act and our regulations at § 410.142 (CMS process for approving national accreditation organizations) and § 410.143 (Requirements for approved accreditation organizations), we review and evaluate a national accreditation organization based on (but not necessarily limited to) the criteria specified in § 410.142(b), and we review the ongoing responsibilities of an approved accreditation organization. We may visit the prospective organization's offices to verify information in the organization's reapplication package, including, but not limited to, review of documents, and interviews with the organization's staff. We may conduct onsite inspection of a national accreditation organization's operations and office to verify information and assess the organization's compliance with its own policies and procedures. The onsite inspection may include, but is not limited to, reviewing documents, auditing documentation from meetings concerning the accreditation process, evaluating accreditation results or the accreditation status decision making process, and interviewing the organization's staff. Notice Upon Completion of Evaluation Upon completion of our evaluation, including consideration of public comments received as a result of this notice, we will publish a final notice in the **Federal Register** announcing the result of our evaluation. III. Response to Comments Because of the large number of public comments we normally receive on **Federal Register** documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. In accordance with the provisions of Executive Order 12866, the Office of Management and Budget did not review this notice. 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) (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: September 6, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicare Services. [FR Doc. E7-18470 Filed 9-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1378-N] Medicare Program; Medicare Provider Feedback Group Town Hall Meeting—October 16, 2007 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. SUMMARY: This notice announces the annual Medicare Provider Feedback Group
(MPFG)Town Hall meeting. This meeting is open to all Medicare fee-for-service
(FFS)providers and suppliers that participate in the Medicare program, including physicians, hospitals, home health agencies, other third-party billers and other interested parties, to present their individual views and opinions on selected FFS Medicare topics. In addition, we will be soliciting input on how we can improve communications to better serve the Medicare providers and suppliers. The meeting agenda and discussion materials will be available by October 12, 2007. The public can access these materials at *http://www.cms.hhs.gov/center/provider.asp.* The feedback provided during this meeting will assist us as we evaluate FFS Medicare policy, operational issues and CMS' provider and supplier communication activities. The meeting is open to the public, but attendance is limited to space available. Registered participants from the meeting will be included in the Medicare Provider Feedback Group and may be contacted throughout the year for follow-up meetings to solicit additional opinions and clarify any issues that may arise from the October 16, 2007 meeting. DATES: *Meeting Date:* The Town Hall meeting announced in this notice will be held on Tuesday, October 16, 2007, from 2 p.m. to 4 p.m. e.s.t. ADDRESSES: The Town Hall 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. *Written Questions or Statements:* Any interested party may send written comments electronically. We will give consideration to feedback received on the topics discussed at the Town Hall meeting, but written responses will not be provided. We will accept and take into consideration written feedback, questions, or other statements about the town hall meeting and agenda topics before the meeting, and up until October 26, 2007. Send written feedback, questions, or other statements to Colette Shatto at *MFG@cms.hhs.gov* . FOR FURTHER INFORMATION CONTACT: Colette Shatto, 410-786-6932. You may also send inquires about this meeting by *MFG@cms.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background CMS has held three Medicare Provider Feedback Group Town Hall Meetings beginning in 2005. The purpose of these meetings is to capture individual provider and supplier feedback on relevant FFS Medicare policy and operational issues. As a result, we are able to further advance our efforts to strengthen the Medicare program and enhance our relationship with providers and suppliers. The Town Hall meetings also provide a venue to allow us to continue a process of communicating with individual providers and suppliers through the following year. II. Meeting Format The meeting will begin with an overview of the goals and objectives of the MPFG efforts to gather feedback from individual Medicare physicians, providers, and suppliers. Topics to be discussed during the meeting include, but are not limited to, FFS Medicare implementation of the National Provider Identifier (NPI), Medicare contractor provider satisfaction survey (MCPSS): “Relevancy of questions in the business functions of appeals and medical review”, Medicare contracting reform, and value based purchasing. There will be a question and answer session that offers meeting attendees an opportunity to provide feedback on how CMS serves physicians, providers, and suppliers, as well as make suggestions on how this process can be improved. The time for participants to ask questions and provide feedback will be limited according to the number of registered participants; however, written submissions will be accepted. Individuals who wish to provide written feedback should e-mail Colette Shatto at MFG@cms.hhs.gov. We will give consideration to feedback received on the topics discussed at the Town Hall meeting, but written responses will not be provided. III. Registration Instructions The Division of Provider Relations and Evaluations, Provider Communications Group, Center for Medicare Management, is coordinating the meeting registration. While there is no registration fee, individuals, providers, and suppliers must register to participate. Individuals interested in attending the meeting in person or by teleconference must complete the on-line registration located at *http://registration.intercall.com/go/cms2.* The on-line registration system will capture contact information and practice characteristics, such as names, e-mail addresses, and provider and supplier types. Registration will be open on September 28, 2007 and close on October 12, 2007. Registration after 5 p.m. e.s.t. on October 12, 2007 will not be accepted. 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. Teleconference instructions will be issued once participants have registered by using the on-line registration tool. If seating capacity has been reached, you will be notified that the meeting has reached capacity. *Special Accommodations:* Individuals requiring sign language interpretation or other special accommodations must contact Colette Shatto by e-mail at *MFG@cms.hhs.gov* . IV. Security, Building, and Parking Guidelines Because this meeting will be located on Federal property, for security reasons, any persons wishing to attend this meeting must register by 5 p.m. e.s.t. on October 12, 2007. Individuals who have not registered in advance will not be allowed to enter the building to attend the meeting. Seating capacity is limited to the first 250 registrants. The on-site check-in for visitors will be held from 12:30 p.m. to 1:30 p.m. e.s.t. Please allow sufficient time to go through the security checkpoints. It is suggested that you arrive at 7500 Security Boulevard no later than 1:30 p.m. e.s.t. so that you will be able to arrive promptly at the meeting by 2 p.m. e.s.t. All items brought to the building, whether personal or for the purpose of demonstration or to support a presentation, are subject to inspection. Security measures will include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all persons entering the building must pass through a metal detector. All items brought to CMS, including personal items such as desktops, cell phones, and palm pilots, are subject to physical inspection. Authority: Section 1811 and 1831 of the Social Security Act (42 U.S.C. 1395c and 1395j). Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program. Dated: September 6, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-18113 Filed 9-27-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Notice of a new System of Records (SOR). SUMMARY: In accordance with the Privacy Act of 1974, we are proposing to establish a new SOR, “Post-Acute Care Payment Reform / Continuity of Assessment Record and Evaluation Demonstration and Evaluation (PAC-CARE),” System No. 09-70-0569. Information maintained in this system will continue to enable CMS to better understand the relationships among patient needs, post-acute care placement, patient outcomes, and post-acute care related costs in the Medicare program. Additionally, as required by Section 5008 of the Deficit Reduction Act of 2005, CMS is developing a comprehensive assessment for use at the time of hospital discharge which identifies the needs and clinical characteristics of the patient. Additionally, this standardized patient assessment instrument shall be used across post-acute care sites, including skilled nursing facilities, home health agencies, long term care hospitals and inpatient rehabilitation facilities, to measure functional status and other factors during treatment and at discharge from each provider. CMS proposes to broaden the scope of the disclosure requirement by adding a new routine use number 6, authorizing disclosure of personal health information to providers to facilitate the proper transfer of health information for beneficiaries being discharged from their site of care to an admitting provider's care. Individuals from the admitting providers will only be granted access to personal health information, if they have the approved, authenticated, role based authority to do so, and the need to know and review the admitted patient's personal health information. Individuals will only be granted access to this information if they meet the following requirements: they must
(1)provide an attestation or other qualifying information that they are providing assistance to qualified acute care or post-acute care beneficiaries admitted to their care site,
(2)have physically admitted the beneficiary to their site and have initiated an assessment of the beneficiary,
(3)safeguard the confidentiality of the data and prevent unauthorized access, and
(4)accept an on-line statement attesting to the information recipient's understanding of and willingness to abide by these provisions. The routine uses will then be prioritized and reordered according to their usage. The primary purpose of this proposed system is to collect and maintain, and release when appropriate, demographic, health records, and health resource use related data on the target population of Medicare and potentially, Medicaid beneficiaries who require treatment by a designated acute care or post-acute care provider. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent;
(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;
(4)support the functions of Quality Improvement Organizations;
(5)support the functions of national accreditation organizations;
(6)permit the release of personal health information to complete a transfer-out (discharge) event and/or a transfer-in (admission) event;
(7)support litigation involving the agency; and
(8)combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the modified 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 modified or altered routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period. EFFECTIVE DATES: CMS filed a new system report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget
(OMB)on September 21, 2007. To ensure that all parties have adequate time in which to comment, the new system, including routine uses, will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and Congress, whichever is later, unless CMS receives comments that require alterations to this notice. ADDRESSES: The public should address comments to: CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Office of Information Services, CMS, Room N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9 a.m.-3 p.m., Eastern Time zone. FOR FURTHER INFORMATION CONTACT: Shannon Flood, Division of Research on Traditional Medicare, Research and Evaluation Group, Office of Research Development & Information, Mail Stop C3-19-26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. She can be reached by telephone at 410-786-2583, or via e-mail at *Shannon.Flood@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: As required by Section 5008 of the Deficit Reduction Act of 2005, CMS is developing a comprehensive assessment for use at the time of hospital discharge which identifies the needs and clinical characteristics of the patient. Additionally this standardized patient assessment instrument shall be used across post-acute care sites, including skilled nursing facilities, home health agencies, long term care hospitals and inpatient rehabilitation facilities, to measure functional status and other factors during treatment and at discharge from each provider. This standardized patient assessment instrument is being developed under a contract between the CMS Office of Clinical Standards & Quality and the Research Triangle International
(RTI)is referred to as “Continuity Assessment Record and Evaluation (CARE).” CARE consists of a set of assessment items under 5 major domains: medical, functional, social/environmental, cognitive and continuity of care. This assessment data, as well as demographic, medication, procedure, and treatment information will be collected for Medicare and potentially Medicaid beneficiaries. The CARE instrument will provide a foundation for a continuity of care record for patients across settings, over time. The new proposed routine use
(6)refers only to data contained within the CARE tool and not the other data used in the project. The CARE tool is one of the data collection aspects of the demonstration. In addition, the demonstration will make use of such information as claims, staff time measurement logs, and unstructured staff interviews in its analyses. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for this system is given under Sections 5008 of the Deficit Reduction Act of 2005. B. Collection and Maintenance of Data in the System This system will collect and maintain individually identifiable and other data collected on Medicare and potentially Medicaid beneficiaries who require treatment in a designated acute care or post-acute care provider. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. The collected information will include, but is not limited to: Medicare claims and eligibility data, name, health insurance claims number (HICN), social security number
(SSN)(the submission of a beneficiary's SSN is optional), race/ethnicity, gender, date of birth, provider name, unique CMS Certification Number (CCN), medical record number, as well as clinical, demographic, medication, procedure, treatment information, health/well-being, and background information relating to Medicare issues. Data will be collected from Medicare administrative and claims records, PAC-CARE site administrative data systems, patient medical charts, physician records, and via information submitted by beneficiaries and providers. II. Agency Policies, Procedures, and Restrictions on Routine Uses A. Agency Policies, Procedures, and Restrictions on the Routine Use The Privacy Act permits us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a “routine use.” The government will only release PAC-CARE information that can be associated with an individual as provided for under “Section III. Proposed Routine Use Disclosures of Data in the System.” Both identifiable and non-identifiable data may be disclosed under a routine use. We will only collect the minimum personal data necessary to achieve the purpose of PAC-CARE. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from this system will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS: 1. Determines that the use or disclosure is consistent with the reason that the data is being collected, e.g., to collect and maintain, and release when appropriate, demographic, health, and health resource use related data on the target population of Medicare and potentially Medicaid beneficiaries who require treatment by a designated acute care or post-acute care provider. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. 2. Determines that: a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; b. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and c. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s). 3. Requires the information recipient to: a. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record; b. Remove or destroy at the earliest time all patient-identifiable information; and c. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed. 4. Determines that the data are valid and reliable. III. Proposed Routine Use Disclosures of Data in the System A. The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor or consultant to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant or grantee from using or disclosing the information for any purpose other than that described in the contract and requires the contractor, consultant or grantee to return or destroy all information at the completion of the contract. 2. To another Federal or state agency to: a. Contribute to the accuracy of CMS's proper payment of Medicare benefits; b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. Assist Federal/state Medicaid programs within the state. Other Federal or state agencies, in their administration of a Federal health program, may require PAC-CARE information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. 3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. The PAC-CARE data will provide for research or support of evaluation projects and a broader, longitudinal, national perspective of the status of Medicare beneficiaries. CMS anticipates that researchers may have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicare beneficiaries and the policies that govern their care. 4. To support Quality Improvement Organizations
(QIO)in connection with review of claims, or in connection with studies or other review activities conducted pursuant to Part B of Title XI of the Act, and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. The QIO may use this data to support quality improvement activities and other QIO responsibilities as detailed in Title XI §§ 1151-1164. The QIO will work to implement quality improvement programs, provide consultation to CMS, its contractors, and to state agencies. The QIO will assist state agencies in related monitoring and enforcement efforts, assist CMS and intermediaries in program integrity assessment, and prepare summary information for release to CMS. 5. To assist national accreditation organization(s) whose accredited facilities are deemed to meet certain Medicare conditions of participation for inpatient hospital rehabilitation services (e.g., the Joint Commission and the American Osteopathic Association) with their survey process information will be released by CMS for only those providers that they deem and that participate in the Medicare program if they meet the following requirements: a. Provide identifying information for post acute care facilities that have deemed status with the requesting accreditation organization; b. Submission of a finder file identifying beneficiaries/patients receiving post-acute care services; c. Safeguard the confidentiality of the data and prevent unauthorized access; and d. Upon completion of a signed data exchange agreement or a CMS data use agreement. At this time, CMS anticipates providing accreditation organizations with PAC-CARE information to enable them to target potential identified problems during the organization's accreditation review process of the facility. 6. To assist with a transfer-out event from a discharging acute or post-acute care provider and/or a transfer-in event to an admitting acute or post-acute care provider to: a. Contribute to the accuracy of CMS' proper payment of Medicare benefits; and b. Enable such providers to ensure the proper transfer of health records, and/or as necessary to enable such a provider to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal fund. Individuals from the admitting providers will only be granted access to personal health information, if they have the approved, authenticated, role-based authority, and the defined need for access to that information. Individuals will only be granted access to information if they meet the following requirements: a. Provide an attestation or other qualifying information that they are providing assistance to a qualified acute or post-acute care beneficiary receiving care/services through their provider site; b. Have physically admitted the beneficiary to their care site, and are initiating an assessment of the beneficiary, and can validate the beneficiary's name, HICN (or payer number or SSN), date of birth, and gender; c. Safeguard the confidentiality of the data and prevent unauthorized access; and d. Accept a written, on-line statement attesting to the information recipient's understanding of and willingness to abide by these provisions. The PAC-CARE data will give the provider patient-specific personal health information which may facilitate the provider's required utilization reviews and medication management program activities; and assist in quality of care issues as they relate to the beneficiary. 7. To the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government is a party to litigation or has an interest in such litigation, and, by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. Whenever CMS is involved in litigation, and occasionally when another party is involved in litigation and CMS policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved. 8. To a CMS contractor (including, but not necessarily limited to, Medicare Administrative Contractors (MAC), fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, and abuse in such program. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual, grantee, cooperative agreement or consultant relationship with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud, waste, and abuse. CMS occasionally contracts out certain of its functions or makes grants or cooperative agreements when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, grantee, consultant or other legal agent whatever information is necessary for the agent to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the agent from using or disclosing the information for any purpose other than that described in the contract and requiring the agent to return or destroy all information. 9. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. Other agencies may require PAC-CARE information for the purpose of combating fraud, waste, and abuse in such Federally-funded programs. B. Additional Provisions Affecting Routine Use Disclosures To the extent this system contains Protected Health Information
(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR Parts 160 and 164, Subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals could, because of the small size, use this information to deduce the identity of the beneficiary). IV. Safeguards CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations include but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent NIST publications; the DHHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects of the Modified System of Records on Individual Rights CMS proposes to modify this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in the system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: September 18, 2007. Charlene Frizzera, Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0569 SYSTEM NAME: “Post-Acute Care Payment Reform / Continuity of Assessment Record and Evaluation Demonstration and Evaluation (PAC-CARE),” HHS/CMS/ORDI. SECURITY CLASSIFICATION: Level Three Privacy Act Sensitive Data. SYSTEM LOCATION: The Centers for Medicare & Medicaid Services
(CMS)Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various contractor sites and at CMS Regional Offices. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: This system will collect and maintain individually identifiable and other data collected on Medicare and potentially, Medicaid beneficiaries who require treatment in a designated acute care or post-acute care provider. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. CATEGORIES OF RECORDS IN THE SYSTEM: The collected information will include, but is not limited to: Medicare claims and eligibility data, name, health insurance claims number (HICN), social security number
(SSN)(the submission of a beneficiary's SSN is optional), race/ethnicity, gender, date of birth, provider name, unique CMS Certification Number (CCN), medical record number, as well as clinical, demographic, medication, procedure, treatment information, health/well-being, and background information relating to Medicare issues. Data will be collected from Medicare administrative and claims records, PAC-CARE site administrative data systems, patient medical charts, physician records, and via information submitted by beneficiaries and providers. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: The statutory authority for this system is given under Sections 5008 of the Deficit Reduction Act of 2005. PURPOSE(S) OF THE SYSTEM: The primary purpose of this proposed system is to collect and maintain, and release when appropriate, demographic, health records, and health resource use related data on the target population of Medicare and potentially, Medicaid beneficiaries who require treatment by a designated acute care or post-acute care provider. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent;
(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;
(4)support the functions of Quality Improvement Organizations;
(5)support the functions of national accreditation organizations;
(6)permit the release of personal health information to complete a transfer-out (discharge) event and/or a transfer-in (admission) event;
(7)support litigation involving the agency; and
(8)combat fraud, waste, and abuse in certain Federally-funded health benefits programs. ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OR USERS AND THE PURPOSES OF SUCH USES: A. The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. 2. To another Federal or state agency to: a. Contribute to the accuracy of CMS's proper payment of Medicare benefits; b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. Assist Federal/state Medicaid programs within the state. 3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. 4. To support Quality Improvement Organizations
(QIO)in connection with review of claims, or in connection with studies or other review activities conducted pursuant to Part B of Title XI of the Act, and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. 5. To assist national accreditation organization(s) whose accredited facilities are deemed to meet certain Medicare conditions of participation for inpatient hospital rehabilitation services ( *e.g.* , the Joint Commission and the American Osteopathic Association) with their survey process, information will be released by CMS for only those providers that they deem and that participate in the Medicare program and if they meet the following requirements: a. Provide identifying information for post acute care facilities that have deemed status with the requesting accreditation organization; b. Submission of a finder file identifying beneficiaries/patients receiving post acute care services; c. Safeguard the confidentiality of the data and prevent unauthorized access; and d. Upon completion of a signed data exchange agreement or a CMS data use agreement. 6. To assist with a transfer-out event from a discharging acute or post-acute care provider and/or a transfer-in event to an admitting acute or post-acute care provider to: a. Contribute to the accuracy of CMS' proper payment of Medicare benefits; and b. Enable such providers to ensure the proper transfer of health records, and/or as necessary to enable such a provider to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal fund. Individuals from the admitting providers will only be granted access to personal health information, if they have the approved, authenticated, role-based authority, and the defined need for access to that information. Individuals will only be granted access to information if they meet the following requirements: a. Provide an attestation or other qualifying information that they are providing assistance to a qualified acute or post-acute care beneficiary receiving care/services through their provider site; b. Have physically admitted the beneficiary to their care site, and are initiating an assessment of the beneficiary, and can validate the beneficiary's name, HICN (or payer number or SSN), date of birth, and gender; c. Safeguard the confidentiality of the data and prevent unauthorized access; and d. Accept a written, on-line statement attesting to the information recipient's understanding of and willingness to abide by these provisions. 7. To the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government is a party to litigation or has an interest in such litigation, and, by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. 8. To a CMS contractor (including, but not necessarily limited to, Medicare Administrative Contractors (MAC), fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, and abuse in such program. 9. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures. To the extent this system contains Protected Health Information
(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR Parts 160 and 164, Subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals could, because of the small size, use this information to deduce the identity of the beneficiary). POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: All records are stored on magnetic media. RETRIEVABILITY: The Medicare records are retrieved by the HICN and SSN. SAFEGUARDS: CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002; the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the DHHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: Records will be retained until an approved disposition authority is obtained from the National Archives and Records Administration. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. SYSTEM MANAGER(S) AND ADDRESS: Director, Research and Evaluation Group, Office of Research Development & Information, Mail Stop C3-19-26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. NOTIFICATION PROCEDURE: For purpose of access, the subject individual should write to the system manager who will require the system name, HICN, address, date of birth, and gender, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), and SSN. Furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay. RECORD ACCESS PROCEDURE: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also specify the record contents being sought. (These procedures are in accordance with department regulation 45 CFR 5b.5(a)(2)). CONTESTING RECORDS PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the records and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These Procedures are in accordance with Department regulation 45 CFR 5b.7). RECORDS SOURCE CATEGORIES: Data will be collected from Medicare administrative and claims records (Outcome and Assessment Information Set, Inpatient Rehabilitation Facilities Patient Assessment Instrument, Long Term Care Minimum Data Set), post-acute care site administrative data systems, patient medical charts, physician records, and via information submitted by beneficiaries and providers. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E7-19110 Filed 9-27-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Office of Planning, Research and Evaluation AGENCY: Office of Planning, Research and Evaluation (OPRE), Administration for Children and Families (ACF), Department of Health and Human Services (HHS). ACTION: Notice. CFDA#: 93.600. Statutory Authority: Section 649 of the Head Start Act, as amended by the COATES Human Services Reauthorization Act of 1998 (Pub. L. 105-285) and 42 U.S.C. 9844. SUMMARY: Notice is hereby given that the Administration for Children and Families (ACF), Office of Planning, Research and Evaluation
(OPRE)will award a non-competitive successor grant to OMNI Institute, Inc., a non-profit research organization located in Denver, CO. OMNI Institute, Inc. will assume a grant awarded under the Head Start University Partnership Research Grants: Curriculum Development and Enhancement for Head Start and Early Head Start Programs for the remainder of the project period July 15, 2007 to September 29, 2008. This action is taken as the original grantee, the University of Colorado Health Sciences Center, has relinquished the grant. FOR FURTHER INFORMATION CONTACT: Wendy DeCourcey, PhD., Social Science Research Analyst, Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade, SW., Washington, DC 20447, or by phone at
(202)260-2039, or by e-mail at *wdecourcey@acf.hhs.gov.* Dated: September 24, 2007. Naomi Goldstein, Director, Office of Planning, Research and Evaluation. [FR Doc. E7-19276 Filed 9-27-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Revision of OMB No. 0925-0001/exp. 09/30/07, Research and Research Training Grant Applications and Related Forms SUMMARY: 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 for review and approval of the information collection listed below. This proposed information collection was previously published in the **Federal Register** on July 24, 2007, page 40313 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The 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 September 30, 2007, unless it displays a currently valid OMB control number. *Proposed Collection: Title:* Research and Research Training Grant Applications and Related Forms. *Type of Information Collection Request:* Revision, OMB 0925-0001, Expiration Date 9/30/2007, Form Numbers: PHS 398, 2590, 2271, 3734 and HHS 568. *Need and Use of Information Collection:* The application is used by applicants to request Federal assistance for research and research-related training. The other related forms are used for trainee appointment, final invention reporting, and to relinquish rights to a research grant. *Frequency of Response:* Applicants may submit applications for published receipt dates. If awarded, annual progress is reported and trainees may be appointed or reappointed. *Affected Public:* Individuals or Households; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. *Type of Respondents:* Adult scientific professionals. The annual reporting burden is as follows: *Estimated Number of Respondents:* 164,820; *Estimated Number of Responses per Respondent:* 1; *Average Burden Hours per Response:* 15.2; and *Estimated Total Annual Burden Hours Requested:* 2,517,458. The estimated annualized cost to respondents is $88,110,030. *Request for Comments:* 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. *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, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Contact Ms. Mikia Currie, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number 301-435-0941, or e-mail your request, including your address to: *curriem@od.nih.gov.* *Comments 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. Dated: September 25, 2007. Mikia Currie, Program Analyst, National Institutes of Health. [FR Doc. E7-19265 Filed 9-27-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Statement of Organization, Functions, and Delegations of Authority Part M of the Substance Abuse and Mental Health Services Administration (SAMHSA) Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services at 72, Number 73, page 19209, April 17, 2007 is amended to reflect changes to the structure and functional statements for the Office of Applied Studies (OAS). This amendment reflects the abolishment of the Division of Analysis, and also reflects OAS's increased responsibilities for performance data on State block grants (the State Outcome Measures and Monitoring System (SOMMS)). In addition, the title of the Division of Operations is replaced with the Division of Facility Surveys, and the functional statement of the Division of Populations Surveys, and the Office of the Director are also replaced. These changes will permit the OAS to increase its emphasis on:
(1)The use of data sets to support SAMHSA's policy, planning, and program development;
(2)customer service; and
(3)the integration of analytic and data collection activities for each survey. The changes are as follows: *Section M.20, Functions* is amended as follows: The functional statements for the Office of Applied Studies (OAS), Office of the Director is replaced; Division of Analysis is abolished; Division of Operations is abolished and replaced with the Division of Facility Surveys; and the functional statement for the Division of Populations Surveys is replaced. Office of Applied Studies
(MC)Office of the Director (MC-1)
(1)Provides overall leadership for the Office of Applied Studies;
(2)determines that data collection and analytic activities are consistent with the mission and priorities of the Department and the Agency;
(3)advises the Administrator and other Agency officials and staff on policy and technical issues associated with collecting information on substance abuse and mental health problems;
(4)serves as Agency liaison to the Office of the Secretary, the Office of National Drug Control Policy, the Drug Enforcement Administration, and other Federal agencies; to State and local government agencies; and to non-governmental organizations and institutions on matters related to the collection and analysis of data on substance abuse and mental health problems;
(5)manages SAMHSA responsibilities under the Paperwork Reduction Act, including the process for obtaining Office of Management and Budget clearance for information collection activities; and
(6)manages the process for clearing, publishing, and disseminating studies and reports produced by OAS. Division of Population Surveys
(1)Plans, develops, and manages the National Survey on Drug Use and Health (NSDUH) and other surveys of the population to obtain information on substance abuse and mental health problems;
(2)develops, implements, and evaluates new statistical and data collection methods, questionnaires, and sampling strategies for surveys;
(3)analyzes information obtained from surveys conducted by the Office of Applied Studies to determine the incidence, prevalence, correlates, and consequences of substance abuse;
(4)obtains and analyzes data from various sources to examine program and policy issues and evaluate the impact of various Federal initiatives related to substance abuse;
(5)prepares statistical publications, special reports, and analyses based on information derived from the NSDUH and other surveys of the population;
(6)serves as a source of expertise on substance abuse survey methods, sampling design, statistics, and analytic techniques for SAMHSA and the Department; and
(7)determines the annual allotment of Block Grant funds to States and Territories for substance abuse prevention and treatment and mental health services, and provides information and expertise to SAMHSA, the Department, and the States on issues related to the formula in accordance with legislative authorities. Division of Facility Surveys
(1)Plans, develops, and manages the Drug Abuse Warning Network
(DAWN)to obtain information on substance abuse-related morbidity and mortality;
(2)plans, develops, and manages the Drug and Alcohol Services Information System (DASIS), and other data collection projects on admissions to and services provided by treatment programs in the United States;
(3)prepares statistical publications and reports based on data obtained from DAWN, DASIS, and other sources;
(4)analyzes data from facility surveys and other sources to study program and policy issues and evaluate the impact of various Federal initiatives related to substance abuse;
(5)organizes and manages various meetings to share information and obtain advice and assistance from States with respect to the data collected from substance abuse treatment facilities; and
(6)manages the compilation, analysis, and coordination of performance data on block grants to the States. Delegation of Authority All delegations and redelegations of authority to officers and employees of SAMHSA which were in effect immediately prior to the effective date of this reorganization shall continue to be in effect pending further redelegations, providing they are consistent with the reorganization. These organizational changes are effective: September 24, 2007. Terry L. Cline, Administrator. [FR Doc. 07-4773 Filed 9-27-07; 8:45 am]
Connectionstraces to 7
12 references not yet in our index
  • Pub. L. 100-578
  • 42 CFR 493
  • 42 CFR 493.551(a)
  • 42 CFR 430.15(c)(2)
  • 42 CFR 430
  • 42 CFR 430.76(b)(2)
  • 42 CFR 430.76(c)
  • 42 CFR 430.18
  • 42 CFR 410
  • 45 CFR 164.512(a)(1)
  • 45 CFR 5
  • Pub. L. 105-285
Citation graph
cites case law
Notices
Notice
U.S.C.§ 242k
U.S.C.§ 263a
U.S.C.§ 1316
Fed. Reg.Notices
U.S.C.§ 1395bb
U.S.C.§ 1395c
U.S.C.§ 9844
Pub. L.Pub. L. 100-578
Cite42 CFR 493
Cite42 CFR 493.551(a)
Cite42 CFR 430.15(c)(2)
Cite42 CFR 430
Cites 19 · showing 12Cited by 0 across 0 sources
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