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Code · REGISTER · 2007-03-23 · DEPARTMENT OF HEALTH AND HUMAN SERVICES · Notices

Notices. Notice

14,973 words·~68 min read·/register/2007/03/23/07-1459

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

BILLING CODE 4150-29-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Environmental Health/Agency for Toxic Substances and Disease Registry Community and Tribal Subcommittee
(CTS)of the Board of Scientific Counselors (BSC), Centers for Disease Control and Prevention (CDC), National Center for Environmental Health (NCEH)/Agency for Toxic Substances and Disease Registry (ATSDR): Teleconference. In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention, NCEH/ATSDR announces the following teleconference meeting of the aforementioned subcommittee: *Time and Date:* 1 p.m.-3 p.m., April 17, 2007. *Place:* The teleconference will originate at NCEH/ATSDR in Atlanta, Georgia. Please see *Supplementary Information* for details on accessing the teleconference. *Status:* Open to the public, teleconference access is limited only by the availability of telephone ports. *Purpose:* Under the charge of the BSC, NCEH/ATSDR, the CTS will provide the BSC, NCEH/ATSDR with a forum for community and tribal first hand perspectives on the interactions and impacts of the NCEH/ATSDR's national and regional policies, practices and programs. *Matters to be Discussed:* The meeting agenda will include a discussion on the ATSDR Environmental Justice Web site, a discussion on the ongoing NCEH/ATSDR activities related to health disparities and environmental justice, and a discussion on agenda items for the May 16, 2007 CTS Meeting. Items are subject to change as priorities dictate. *Supplementary Information:* This teleconference meeting is scheduled to begin at 1 p.m. Eastern Daylight Saving Time. To participate, please dial 1-877-315-6535 and enter conference code 383520. You will then be automatically connected to the call. The public comment period is scheduled from 2 p.m.-2:10 p.m. Eastern Daylight Saving Time. *Contact Person for More Information:* Sandra Malcom, Committee Management Specialist, NCEH/ATSDR, 1600 Clifton Road, Mail Stop E-28, Atlanta, GA 30303; telephone 404-498-0622, fax 404-498-0059; E-mail: *SMalcom@cdc.gov* . The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-5341 Filed 3-22-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10053] 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:* Paid Feeding Assistants in Long Term Care Facilities and Supporting Regulations at 42 CFR 483.160. *Use:* 42 CFR part 483 permits long-term care facilities to use paid feeding assistants to supplement the services of certified nurse aides. If facilities choose this option, feeding assistants must completed a specified training program. In addition, a facility must maintain a record of all individuals, used by the facility as feeding assistants, who have successfully completed the training course for paid feeding assistants. This information is used as part of the process to determine facility compliance with this requirement. *Form Number:* CMS-10053 (OMB#: 0938-0916); *Frequency:* Recordkeeping—once; *Affected Public:* Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 8,772; *Total Annual Responses:* 3,509; *Total Annual Hours:* 21,054. 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: Katherine Astrich, New Executive Office Building, Room 10235, Washington, DC 20503, *Fax Number:*
(202)395-6974. Dated: March 8, 2007. Michelle Shortt, Director, Regulations Development Group Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-4900 Filed 3-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10220] Agency Information Collection Activities: Proposed Collection; 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)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 functions;
(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:* New collection; *Title of Information Collection:* Provider Enrollment Chain and Ownership System (PECOS) Web Security Consent Form; *Form No.:* CMS-10220 (OMB# 0938-NEW); *Use:* In establishing a Web based application process, we allow providers and suppliers the ability to enroll in the Medicare program via the Internet. For these applicants, no security consent form is needed to enroll or make a change in their Medicare enrollment information. These applicants receive complete access to their own enrollments through the Web based version of the Provider Enrollment, Chain and Ownership System (PECOS). In order to allow a provider or supplier to delegate the Medicare credentialing process to another individual or organization, it is necessary to establish a Security Consent Form for those providers and suppliers who choose to have another individual or organization access their enrollment information and complete enrollments on their behalf. These users could consist of administrative staff, independent contractors, or credentialing departments and are represented as a User group. User groups and its members must request access to enrollment data through a Security Consent Form. The security consent form replicates business service agreements between Medicare applicants and organizations providing enrollment services. We are proposing four different versions of the Security Consent Form. The form, once signed, mailed and approved, grants a user group or its member access to specific Medicare enrollment records. The system administrator, within the user group, assigns to each member of the group, a security role that will define their levels of functionality within PECOS web for an individual or organization. *Frequency:* Reporting—On occasion; *Affected Public:* Business or other for-profit, Not-for-profit institutions, Individuals or Households; *Number of Respondents:* 177,500; *Total Annual Responses:* 177,500; *Total Annual Hours:* 44,375. 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. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on May 22, 2007. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—B, *Attention:* William N. Parham, III, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: March 8, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-4901 Filed 3-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10095] 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:* Detailed Explanation of Non-Coverage and Notice of Medicare Non-Coverage and Supporting Regulations in 42 CFR 422.624 and 42 CFR 422.626; *Use:* Providers will deliver a Notice of Medicare Non-Coverage to enrollees at least two days prior to the end of covered services in skilled nursing facilities, home health agencies, and comprehensive outpatient rehabilitation facilities. Enrollees will use this information to determine whether they wish to appeal the service termination to the Quality Improvement Organization
(QIO)in their State. If the enrollee decides to appeal, the Medicare Health organization will send the QIO and the enrollee a Detailed Explanation of Non-Coverage detailing the rationale for the termination decision. *Form Number* : CMS-10095 (OMB#: 0938-0910); *Frequency:* Reporting: Yearly; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 454; *Total Annual Responses:* 47,558; *Total Annual Hours:* 23,780.52. 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: March 16, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-5296 Filed 3-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10216, CMS-R-0053, CMS-179, CMS-10137, CMS-10069 and CMS-R-246] Agency Information Collection Activities: Proposed Collection; 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)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 functions;
(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 without change of a currently approved collection; *Title of Information Collection:* Alternative Benefits State Plan Amendment Health Opportunity Accounts
(HOA)Demonstration Program; *Use:* The DRA provides States with numerous flexibilities in operating their State Medicaid programs. For example, Section 6082 of the DRA allows up to 10 States to operate Medicaid demonstrations to test alternative systems for delivering their Medicaid benefits. Under these demonstrations, States would have the flexibility to deliver their Medicaid benefits to volunteer beneficiaries through a program that is comprised of an HOA and a High Deductible Health Plan (HDHP). Under the DRA, States can submit a State Plan Pre-print to CMS to effectuate this change to their Medicaid programs. CMS will provide a State Medicaid Director letter providing guidance on this provision and the implementation of the DRA and the associated State Plan Amendment template for use by States to modify their Medicaid State Plans if they choose to implement this flexibility; Form Number: CMS-10216 (OMB#: 0938-1007); *Frequency:* Reporting: One-time; *Affected Public:* State, Local or tribal Government; *Number of Respondents:* 56; *Total Annual Responses:* 10; *Total Annual Hours:* 10. 2. *Type of Information Collection Request:* Extension without change of a currently approved collection; *Title of Information Collection:* Imposition of Cost Sharing Charges Under Medicare and Supporting Regulations Contained in 42 CFR 447.53; *Use:* The purpose of this collection is to ensure that States impose nominal cost sharing charges upon categorically and medically needy individuals as allowed by law and implementing regulations. States must identify in their State plan the following:
(1)The service for which the charge is made;
(2)The amount of the charge;
(3)The basis for determining the charge;
(4)The method used to collect the charge;
(5)The basis for determining whether an individual is unable to pay the charge and the way in which the individual will be identified to providers; and,
(6)The procedures for implementing and enforcing the exclusions from cost sharing; * Form Number: * CMS-R-0053 (OMB#: 0938-0429); *Frequency:* Reporting: Occasionally; *Affected Public:* State, Local or tribal Government; *Number of Respondents:* 56; *Total Annual Responses:* 2; *Total Annual Hours:* 20. 3. *Type of Information Collection Request:* Extension without change of a currently approved collection; *Title of Information Collection:* Transmittal and Notice of Approval of State Plan Material and Supporting Regulations in 42 CFR 430.10-430.20 and 440.167; *Use:* The CMS-179 is used by State agencies to transmit State plan material to the Centers for Medicare & Medicaid Services
(CMS)for approval prior to amending their State plan. The State plan is the method in which States inform staff of State policies, standards, procedures and instructions. The CMS-179 is currently used by State agencies administering the Medicaid program and CMS regional offices (RO). State agencies use the form to submit State plan amendments
(SPAs)(including supporting documentation) to the CMS RO for review and approval prior to amending their plan in accordance with 42 CFR 430.10-430.20. The CMS-179 includes instructions for completing the form. The inclusion of instructions is to assist State agencies in completing the form, thereby ensuring a more uniform and timely plan amendment approval process. The CMS-179 is the only source available to State agencies for submittal/approval of SPAs. This plan amendment approval process is necessary to ensure the State plan continues to meet statutory and regulatory requirements and thereby ensure the State's eligibility for Federal financial participation. CMS will use this information to track the estimated Federal budget impact associated with the SPAs. This information may result in more accurate Federal Medicaid expenditure estimates; *Form Number:* CMS-179 (OMB#: 0938-0193); *Frequency:* Reporting: Occasionally; *Affected Public:* State, Local or tribal Government; *Number of Respondents:* 56; *Total Annual Responses:* 10; *Total Annual Hours:* 560. 4. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Application for Prescription Drug Plans (PDP); Application for Medicare Advantage Prescription Drug (MA-PD); Application for Cost Plans To Offer Qualified Prescription Drug Coverage; Application for Employer Group Waiver Plans To Offer Prescription Drug Coverage; Service Area Expansion Application for Prescription Drug Coverage; *Use:* Collection of this information is mandated in Part D of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. The application requirements are codified in Subpart K of 42 CFR part 423. Coverage for the prescription drug benefit is provided through prescription drug plans
(PDPs)that offer drug-only coverage, or through Medicare Advantage
(MA)organizations that offer integrated prescription drug and health care coverage (MA-PD plans). PDPs must offer a basic drug benefit. Medicare Advantage Coordinated Care Plans (MA-CCPs) must offer either a basic benefit or may offer broader coverage for no additional cost. Medicare Advantage Private Fee for Service Plans (MA-PFFS) may choose to offer a Part D benefit. Cost Plans that are regulated under Section 1876 of the Social Security Act, and Employer Group Plans may also provide a Part D benefit. If any of the contracting organizations meet basic requirements, they may also offer supplemental benefits through enhanced alternative coverage for an additional premium. The information will be collected under the solicitation of proposals from PDP, MA-PD, Cost Plan, and Employer Group Waiver Plans applicants. The collected information will be used by CMS to:
(1)Insure that applicants meet CMS requirements, and
(2)support the determination of contract awards. The major program change that has occurred in Part D applications was that CMS removed several attestations related to Health Insurance Portability and Accountability Act (HIPAA), bids and privacy; *Form Number:* CMS-10137 (OMB#: 0938-0936); *Frequency:* Reporting: Once; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 857; *Total Annual Responses:* 857; *Total Annual Hours:* 28,122. 5. *Type of Information Collection Request:* Extension without change of a currently approved collection; *Title of Information Collection:* Medicare Waiver Demonstration Application; *Use:* The Medicare Waiver Demonstration Application will be used to collect standard information needed to implement congressionally mandated and administration high priority demonstrations. The application will be used to gather information about the characteristics of the applicant's organization, benefits, and services they propose to offer, success in operating the model, and evidence that the model is likely to be successful in the Medicare program. The standard application will be used for all waiver demonstrations and will reduce the burden on applicants, provide for consistent and timely information collections across demonstrations, and provide a user-friendly format for respondents; *Form Number:* CMS-10069 (OMB#: 0938-0880); *Frequency:* Reporting: Once; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 75; *Total Annual Responses:* 75; *Total Annual Hours:* 6000. 6. *Type of Information Collection Request:* Extension without change of a currently approved collection; *Title of Information Collection:* Medicare CAHPS Survey; *Use:* The collection of Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey measures is necessary to hold health and prescription drug plans accountable for the quality of care and services they deliver. This requirement will allow CMS to obtain information for the proper oversight of the program. This information is used to help beneficiaries choose among plans, contribute to improved quality of care through identification of quality improvement opportunities, and assist CMS in carrying out its responsibilities; *Form Number:* CMS-R-246 (OMB#: 0938-0732); *Frequency:* Reporting: Yearly; *Affected Public:* Individuals or households; *Number of Respondents:* 660,000; *Total Annual Responses:* 660,000; *Total Annual Hours:* 217,800. 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. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on May 22, 2007. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—A, Attention: Melissa Musotto, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: March 16, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-5297 Filed 3-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1305-N2] Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (DHHS). ACTION: Notice. SUMMARY: This notice invites nominations of members to the Advisory Panel on Ambulatory Payment Classification
(APC)Groups (the Panel). There will be two vacancies on the Panel as of October 1, 2007. Consequently, this solicitation is for two new members. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, CMS, (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We consider the Panel's advice as CMS prepares its annual updates of the hospital Outpatient Prospective Payment System (OPPS). The Secretary rechartered the Panel in 2006 for a 2-year period effective through November 21, 2008. *Nominations:* We will consider nominations if they are received no later than 5 p.m. on May 30, 2007. Please mail or hand deliver nominations to the following address: CMS; *Attn:* Shirl Ackerman-Ross, Designated Federal Official (DFO), Advisory Panel on APC Groups; Center for Medicare Management, Hospital & Ambulatory Policy Group, Division of Outpatient Care; 7500 Security Boulevard, Mail Stop C4-05-17; Baltimore, MD 21244-1850. *Web site:* For additional information on the APC Panel and updates to the Panel's activities, search our Web site at the following: *http://www.cms.hhs.gov/FACA/05_AdvisoryPanelonAmbulatory PaymentClassificationGroups.asp#TopOfPage* . *E-Mail Address: The E-mail address for the Panel is as follows: CMS_APCPanel@cms.hhs.gov.* News media representatives must contact our Public Affairs Office at
(202)690-6145. *Advisory Committees' Information Lines:* The CMS Advisory Committees' Information Line is 1-877-449-5659 (toll free) and
(410)786-9379 (local). SUPPLEMENTARY INFORMATION: I. Background The Secretary is required by section 1833(t)(9)(A) of the Social Security Act (the Act), [as amended by section 201(h) of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999
(BBRA)(Pub. L. 106-113), and redesignated by section 202(a)(2) of the BBRA] to consult with an expert outside advisory panel regarding the clinical integrity of the APC groups and weights that are components of the hospital OPPS. The Charter requires that the Panel meet up to three times annually. We consider the technical advice provided by the Panel as we prepare the proposed and final rules to update the OPPS for the next calendar year. The Panel shall consist of a chair and up to 15 members who are full-time employees of hospitals, hospital systems, or other Medicare providers that are subject to the OPPS. (For purposes of the Panel, consultants or independent contractors are not considered to be full-time employees in these organizations.) The Secretary or Administrator selects the Panel membership based upon either self-nominations or nominations submitted by providers or interested organizations. The current Panel members are as follows: (The asterisk [*] indicates Panel members whose terms begin on March 1, 2007, and the double asterisks [**] indicate Panel members whose terms begin on April 1, 2007. Panel members with three asterisks [***] are those members whose terms expire on or before September 30, 2007.) • E.L. Hambrick, M.D., J.D., Chair, a CMS Medical Officer. • Gloryanne Bryant, B.S., RHIA, RHIT, CCS. • Hazel Kimmel, R.N., CCS, CPC. • Sandra J. Metzler, M.B.A., RHIA.*** • Thomas M. Munger, M.D. • Beverly Khnie Philip, M.D.** • Louis Potters, M.D. • Russ Ranallo, M.S., B.S.* • James V. Rawson, M.D. • Michael A. Ross, M.D.** • Lou Ann Schraffenberger, M.B.A., RHIA. • Judie S. Snipes, R.N., M.B.A., CHE. • Patricia Spencer-Cisek, M.S., APRN-BC, AOCN®.* • Timothy Gene Tyler, Pharm.D.*** • Kim Allen Williams, M.D. • Robert M. Zwolak, M.D. Panel members serve without compensation, according to an advance written agreement; however, CMS reimburses travel, meals, lodging, and related expenses for the meeting in accordance with standard Government travel regulations. CMS has a special interest in attempting to ensure—while taking into account the nominee pool—that the Panel is diverse in all respects to the following: geography; rural or urban practice; race, ethnicity, sex, and disability; medical or technical specialty; and type of hospital, hospital health system, or other Medicare provider. The Secretary, or his designee, appoints new members to the Panel from among those candidates determined to have the required expertise. New appointments are made in a manner that ensures a balanced membership. II. Criteria for Nominees All members must have technical expertise to enable them to participate fully in the work of the Panel. This expertise encompasses hospital payment systems; hospital medical-care delivery systems; provider billing systems; APC groups; Physicians' Current Procedural Terminology and alpha-numeric Healthcare Common Procedure Coding System codes; and the use and payment of drugs and medical devices in the outpatient setting, as well as other forms of relevant expertise. It is not necessary for a nominee to possess expertise in all of the areas listed, but each must have a minimum of 5 years experience and currently have full-time employment in his or her area of expertise. Members of the Panel serve terms up to 4 years, based on the needs of the Panel and contingent upon the rechartering of the Panel. Any interested person or organization may nominate one or more qualified individuals. Self-nominations will also be accepted. Each nomination must include the following: • Letter of Nomination, • Curriculum Vita of the nominee, and • Written statement from the nominee that the nominee is willing to serve on the Panel under the conditions described in this notice and further specified in the Charter. III. Copies of the Charter To obtain a copy of the Panel's Charter, submit a written request to the DFO at the address provided or by e-mail at *CMS_APCPanel@cms.hhs.gov,* or call her at 410-786-4474. Copies of the Charter are also available on the Internet at the following: * http://www.cms.hhs.gov/FACA/05_AdvisoryPanelon AmbulatoryPaymentClassificationGroups.asp#TopOfPage * . Authority: Section 1833(t)(9)(A) of the Act (42 U.S.C. 1395l(t)(9)(A)). The Panel is governed by the provisions of Pub. L. 92-463, as amended (5 U.S.C. Appendix 2). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: March 8, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-5305 Filed 3-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-7004-N] Medicare Program; Announcement of Rechartering and Meeting of the Advisory Panel on Medicare Education, April 17, 2007 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. SUMMARY: This notice announces the renewal of the charter of the Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. In addition, this notice announces a meeting of the Panel on April 17, 2007. This meeting is open to the public. DATES: *Meeting Date:* April 17, 2007 from 9 a.m. to 3:30 p.m., e.d.t. *Deadline for Meeting Registration, Presentations and Comments:* April 10, 2007, 12 noon, e.d.t. *Deadline for Requesting Special Accommodations:* April 2, 2007, 12 noon, e.d.t. ADDRESSES: *Meeting Location:* Hotel Palomar, 2121 P Street, NW., Washington, DC 20037,
(202)448-1800. *Meeting Registration, Presentations, and Written Comments:* Lynne Johnson, Health Insurance Specialist, Division of Forum and Conference Development, Office of External Affairs, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail stop S1-05-06, Baltimore, MD 21244-1850 or contact Ms. Johnson via e-mail at *Lynne.Johnson@cms.hhs.gov.* *Meeting Registration:* The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting Lynne Johnson at the address listed in the ADDRESSES section of this notice or by telephone at
(410)786-0090, by 12 noon, e.d.t., on April 10, 2007. FOR FURTHER INFORMATION CONTACT: Lynne Johnson,
(410)786-0090. Please refer to the CMS Advisory Committees' Information Line (1-877-449-5659 toll free)/(410-786-9379 local) or the Internet ( *http://www.cms.hhs.gov/FACA/04_APME.asp* ) for additional information and updates on committee activities. Press inquiries are handled through the CMS Press Office at
(202)690-6145. SUPPLEMENTARY INFORMATION: Section 222 of the Public Health Service Act (42 U.S.C. 217a), as amended, grants to the Secretary the authority to establish an advisory panel if the Secretary finds the panel necessary and in the public interest. The Secretary signed the charter establishing this Panel on January 21, 1999 as announced in the **Federal Register** (64 FR 7899) and this notice announces the renewal of the charter on November 14, 2006. The charter will terminate on January 21, 2009, unless renewed by the Secretary. The Panel advises and makes recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services
(CMS)on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. The goals of the Panel are as follows: • To develop and implement a national Medicare education program that describes the options for selecting a health plan under Medicare. • To enhance the Federal government's effectiveness in informing the Medicare consumer, including the appropriate use of public-private partnerships. • To expand outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of a national Medicare education program. • To assemble an information base of best practices for helping consumers evaluate health plan options and build a community infrastructure for information, counseling, and assistance. The current members of the Panel are: Anita B. Boles, Independent Consultant, Health Communications; Gwendolyn T. Bronson, SHINE/SHIP Counselor, Massachusetts SHINE Program; Dr. Yanira Cruz, President and Chief Executive Officer, National Hispanic Council on Aging; Clayton Fong, President and Chief Executive Officer, National Asian Pacific Center on Aging; Nan Kirsten-Forte, Executive Vice President, Consumer Services, WebMD; Dr. Jessie C. Gruman, President and Chief Executive Officer, Center for the Advancement of Health; Betty L. Kennard, Vice President, Government Programs and Compliance, Health First Health Plans; Dr. David Lansky, Director, Health Program, Markle Foundation; Dr. Daniel Lyons, Senior Vice President, Government Programs, Independence Blue Cross; Dr. Frank B. McArdle, Manager, Hewitt Research Office, Hewitt Associates; Traci McClellan, J.D., Executive Director, National Indian Council on Aging; Dr. Keith Mueller, Professor and Section Head, Health Services Research and Rural Health Policy, University of Nebraska; Lee Partridge, Senior Health Policy Advisor, National Partnership for Women and Families; Myisha M. Patterson, National Health Coordinator, National Association for the Advancement of Colored People; Rebecca Snead, Executive Vice President/Chief Executive Officer, National Alliance of State Pharmacy Associations; William A. Steel, President, The National Grange; Marvin Tuttle, Jr., CAE, Executive Director and Chief Executive Officer, Financial Planning Association; Catherine Valenti, Chairperson and Chief Executive Officer, Caring Voice Coalition; and Grant Wedner, Web Education, Daily Strength, Inc. In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Panel on April 17, 2007. The agenda for the April 17, 2007 meeting will include the following: • Recap of the previous (January 24, 2007) meeting. • Report on Subcommittee Meetings and Activities. • Partnering Activities Update. • Public Comment. • Listening Session with CMS Leadership. • Next Steps. Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to Lynne Johnson at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make a presentation may submit written comments to Ms. Johnson at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Individuals requiring sign language interpretation or other special accommodations should contact Ms. Johnson at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Authority: Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec. 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR 102-3). (Catalog of Federal Domestic Assistance Program No. 93.733, Medicare—Hospital Insurance Program; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: March 15, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-5299 Filed 3-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1398-NC] Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting Waiver for Organ Procurement Service Area AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice with comment period. SUMMARY: This notice announces a hospital's request for a waiver from entering into an agreement with its designated organ procurement organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver. DATES: *Comment Date:* To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on May 22, 2007. ADDRESSES: In commenting, please refer to file code CMS-1398-NC. 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-1398-NC, P.O. Box 8017, Baltimore, MD 21244-8017. 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-1398-NC, 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 FURTHER INFORMATION CONTACT: Mark A. Horney,
(410)786-4554. 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 the issues. You can assist us by referencing the file code CMS-1398-NC 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 electronic comments received before the close of the comment period on the public 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 [If you choose to comment on issues in this section, please include the caption BACKGROUND at the beginning of your comments.] Organ Procurement Organizations
(OPOs)are not-for-profit organizations that are responsible for the procurement, preservation, and transport of transplantable organs to transplant centers throughout the country. Qualified OPOs are designated by the Centers for Medicare & Medicaid Services
(CMS)to recover or procure organs in CMS-defined exclusive geographic service areas, according to section 371(b)(1)(F) of the Public Health Service Act (42 U.S.C. 273(b)(1)(F)) and our regulations at 42 CFR 486.306. Once an OPO has been designated for an area, hospitals in that area that participate in Medicare and Medicaid are required to work with that OPO in providing organs for transplant, according to section 1138(a)(1)(C) of the Social Security Act (the Act), and our regulations at 42 CFR 482.45. Section 1138(a)(1)(A)(iii) of the Act provides that a hospital must notify the designated OPO (for the service area in which it is located) of potential organ donors. Under section 1138(a)(1)(C) of the Act, every participating hospital must have an agreement to identify potential donors only with its designated OPO. However, section 1138(a)(2)(A) of the Act provides that a hospital may obtain from the Secretary, a waiver of the above requirements under certain specified conditions. A waiver allows the hospital to have an agreement with an OPO other than the one initially designated by CMS, if the hospital meets certain conditions specified in section 1138(a)(2)(A) of the Act. In addition, the Secretary may review additional criteria described in section 1138(a)(2)(B) of the Act to evaluate the hospital's request for a waiver. Section 1138(a)(2)(A) of the Act states that in granting a waiver, the Secretary must determine that the waiver—(1) is expected to increase organ donations; and
(2)will ensure equitable treatment of patients referred for transplants within the service area served by the designated OPO and within the service area served by the OPO with which the hospital seeks to enter into an agreement under the waiver. In making a waiver determination, section 1138(a)(2)(B) of the Act provides that the Secretary may consider, among other factors:
(1)Cost-effectiveness;
(2)improvements in quality;
(3)whether there has been any change in a hospital's designated OPO due to the changes made in definitions for metropolitan statistical areas; and
(4)the length and continuity of a hospital's relationship with an OPO other than the hospital's designated OPO. Under section 1138(a)(2)(D) of the Act, the Secretary is required to publish a notice of any waiver application received from a hospital within 30 days of receiving the application, and to offer interested parties an opportunity to comment in writing during the 60-day period beginning on the publication date in the **Federal Register** . The criteria that the Secretary uses to evaluate the waiver in these cases are the same as those described above under sections 1138(a)(2)(A) and
(B)of the Act and have been incorporated into the regulations at 42 CFR 486.308(e) and (f). II. Waiver Request Procedures [If you choose to comment on issues in this section, please include the caption “Waiver Request Procedures” at the beginning of your comments.] In October 1995, we issued a Program Memorandum (Transmittal No. A-95-11) detailing the waiver process and discussing the information that hospitals must provide in requesting a waiver. We indicated that upon receipt of a waiver request, we would publish a **Federal Register** notice to solicit public comments, as required by section 1138(a)(2)(D) of the Act. According to these requirements, we will review the request and comments received. During the review process, we may consult on an as-needed basis with the Public Health Service's Division of Transplantation, the United Network for Organ Sharing, and our regional offices. If necessary, we may request additional clarifying information from the applying hospital or others. We will then make a final determination on the waiver request and notify the hospital and the designated and requested OPOs. III. Hospital Waiver Request [If you choose to comment on issues in this section, please include the caption “Hospital Waiver Request” at the beginning of your comments.] As permitted by 42 CFR 486.308(e), Select Specialty Hospital-Quad Cities, of Davenport, Iowa has requested a waiver in order to enter into an agreement with a designated OPO other than the OPO designated for the service area in which the hospital is located. Select Specialty Hospital-Quad Cities is requesting a waiver to work with: Iowa Donor Network, 550 Madison Avenue, North Liberty, Iowa 52317. Select Specialty Hospital's Designated OPO is: Gift of Hope Organ and Tissue Donor Network, 660 North Industrial Drive, Elmhurst, IL 60126-1520. Authority: Section 1138 of the Social Security Act (42 U.S.C. 1320b-8). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; Program No. 93.774, Medicare—Supplementary Medical Insurance, and Program No. 93.778, Medical Assistance Program.) Dated: March 16, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-5328 Filed 3-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1488-CN3] RIN 0938-A012 Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates; Final Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised Occupational Mix Adjustment to the Wage Index; Corrections AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Correction of notice. SUMMARY: This document corrects wage index values and a relative weighting factor error that appeared in the correction notice published in the **Federal Register** on January 5, 2007 entitled “Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates; Final Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised Occupational Mix Adjustment to Wage Index; Corrections”. DATES: *Effective Dates.* The corrections to the wage index values listed in items 1a, 1b, and 2 of section III. of this notice are effective as of November 3, 2006. The corrections to the wage index values listed in item 1c of section III. of this notice are effective November 21, 2006. The correction to the relative weighting factor listed in item 3 of section III. of this notice is effective October 1, 2006. FOR FURTHER INFORMATION CONTACT: Brian Slater,
(410)786-5229. SUPPLEMENTARY INFORMATION: I. Background In the October 11, 2006 **Federal Register** (71 FR 59886), we published a notice entitled “Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates; Final Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised Occupational Mix Adjustment to Wage Index” (hereinafter referred to as the “FY 2007 IPPS notice”). After publication of the October 11, 2006 notice, we became aware of errors in the wage indices. Section 412.64(k)(1) of the regulations requires that wage index corrections made after October 1 are effective prospectively for the remainder of the fiscal year from the date the fiscal intermediaries are informed of the correction. We recalculated the wage indices for the affected hospitals, and on November 3, 2006, sent a Joint Signature Memorandum to the fiscal intermediaries informing them to pay hospitals using the corrected wage indices. Subsequent to the November 3, 2006 Joint Signature Memorandum, additional errors in the wage indices were brought to our attention and were corrected through a November 21, 2006 Joint Signature Memorandum. In the January 5, 2007 **Federal Register** (FR Doc. 06-9976, 72 FR 569), we then published a correction notice entitled “Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates; Final Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised Occupational Mix Adjustment to Wage Index; Corrections” (hereinafter referred to as the “FY 2007 IPPS correction notice”) in order to reflect the recalculations included in the two Joint Signature Memoranda. Since the publication of the January 5, 2007 correction notice, we have become aware of several technical errors included in the January 5, 2007 correction notice. The Joint Signature Memoranda used to inform fiscal intermediaries of hospital payment rates did not contain such errors, in part because those Memoranda use a slightly different format for presenting wage index data. Thus, the corrections in this notice do not alter the rates already being used by fiscal intermediaries to pay hospitals. Rather, the corrections ensure that the **Federal Register** accurately reflects the rates actually in place. In sections II. and III. of this correction notice, we summarize, identify, and correct the errors in the January 5, 2007 correction notice. We note that the corrections to items 1a, 1b and 2 of section III. of this notice are effective November 3, 2006; the correction to item 1c of section III of this notice is effective November 21, 2006, and the correction to item 3 of section III of this notice is effective October 1, 2006. II. Summary of the Corrections to the FY 2007 IPPS Correction Notice We made corrections to several of the wage index values that were published in Table 2 in order to ensure that the published tables accurately reflect the rates actually being used by fiscal intermediaries. We also added a sentence to the note that appears at the end of Table 2. In addition, we are making a technical correction in Table 5 to the relative weighting factor listed for DRG 525. III. Correction of Errors In FR Doc. 06-9976 of January 5, 2007 (72 FR 569), make the following corrections: 1. On pages 570 through 571, in Table 2.—Hospital Case-Mix Indexes for Discharges Occurring in Federal Fiscal Year 2005; Hospital Wage Indexes for Federal Fiscal Year 2007; Hospital Average Hourly Wages for Federal Fiscal Years 2005 (2001 Wage Data), 2006 (2002 Wage Data), and 2007 (2003 Wage Data); Wage Indexes and 3-Year Average of Hospital Average Hourly Wages, is corrected by— a. Correcting the following entries effective November 3, 2006: Provider No. FY 2007 wage index 070003 1.2452 070038 1.2591 260015 0.8353 260047 0.8341 340073 0.9775 390044 1.0996 390096 1.0996 b. Deleting the following entries effective November 3, 2006: Provider No. FY 2007 wage index 530008 0.9057 530009 0.9057 530010 0.9057 530011 0.9057 530014 0.9057 530017 0.9057 530032 0.9057 c. Correcting the following entries effective November 21, 2006: Provider No. FY 2007 wage index 230013 1.0492 230019 1.0492 230029 1.0492 230071 1.0492 230130 1.0492 230151 1.0492 230207 1.0492 230223 1.0492 230254 1.0492 230269 1.0492 230277 1.0492 2. On page 571, third column, second full paragraph, that ends with the parenthetical phrase “(April 1-September 30, 2007),” the paragraph is corrected by adding a sentence to read as follows: The separate wage index values for the first and second halves of FY 2007 can be viewed in Supplemental Table 2 on the CMS Web site at: *http://www.cms.hhs.gov/AcuteInpatientPPS/WIFN/list.asp#TopOfPage.* 3. On page 573 in Table 5.—List of Diagnosis-Related Groups (DRGs), Relative Weighting Factors, and Geometric and Arithmetic Mean Length of Stay (LOS), first line (DRG 525), seventh column (weights), the figure “2.2268” is corrected to read “12.2268”. IV. Discussion of Effective Date and Notice and Comment Rulemaking We ordinarily publish a notice of proposed rulemaking in the **Federal Register** to provide a period for public comment before the provisions of a rule take effect in accordance with section 553(b) of the Administrative Procedure Act
(APA)(5 U.S.C. 553(b). In addition, a final rule would ordinarily require a 30-day delay in effective date after the date of publication in the **Federal Register** . This correction of the rates published in the FY 2007 IPPS notice and subsequent FY 2007 IPPS correction notice does constitute a rule under the Administrative Procedure Act, because in our FY 2007 IPPS final rule (71 FR 47870, August 18, 2006), we already published the methodologies and formulas we use for determining the wage index, geographic adjustment factors, and other rates. This notice does not change our methodology or formulas, but merely ensures that our notice accurately reflects the rates that are already being used to pay hospitals. As this notice is not a rule under the Administrative Procedure Act, no notice of proposed rulemaking or delay in effective date is necessary. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: March 16, 2007. Ann C. Agnew, Executive Secretary to the Department. [FR Doc. E7-5290 Filed 3-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1384-N] Medicare Program; Extension of Certain Hospital Wage Index Reclassifications AGENCY: Centers for Medicare & Medicaid Services
(CMS)HHS. ACTION: Notice. SUMMARY: This notice announces the extension of the expiration date for certain geographic reclassifications as implemented by Division B, Title I, section 106 of the Tax Relief and Health Care Act of 2006. These geographic classifications, which affected hospitals' wage indices, were previously set to expire on March 31, 2007 and are now extended to September 30, 2007. DATES: *Effective Date:* April 1, 2007. FOR FURTHER INFORMATION CONTACT: Brian Slater, for hospital inpatient prospective payment systems questions,
(410)786-5229. Chris Smith-Ritter, for hospital outpatient prospective payment systems questions,
(410)786-4636. SUPPLEMENTARY INFORMATION: I. Background Section 508 of Pub. L. 108-173 (hereinafter referred to as “section 508”) permitted a qualifying hospital to appeal the wage index classification otherwise applicable to the hospital and apply for reclassification to another area of the State in which the hospital was located (or, at the discretion of the Secretary, to an area within a contiguous State). Hospitals were required to submit their applications by February 15, 2004. In the February 13, 2004 **Federal Register** (69 FR 7340), we published a notice that described our implementation of section 508. The Congress limited the reclassifications under section 508 to a 3-year period beginning April 1, 2004 and ending March 31, 2007. Generally, geographic reclassifications are in effect for at least one entire Federal fiscal year (October 1 to September 30). However, in the FY 2006 IPPS final rule, to coincide with the end of section 508 reclassifications on March 31, 2007, we established special procedural rules under which individual and group reclassifications could take effect for only the second half of the fiscal year, from April 1 through September 30, 2007 (70 FR 47382, August 12, 2005). Consistent with those procedural rules, for FY 2007, some hospitals or geographic areas were assigned different geographic reclassifications and wage indices for the 1st half of FY 2007 than were assigned for the 2nd half of FY 2007 (71 FR 59886). Further, in accordance to section 1886(d)(8)(D) of the Act, we apply an adjustment to the IPPS standardized amounts to ensure that the effects of geographic reclassification are budget neutral. For FY 2008, we calculated one budget neutrality adjustment that reflects the average of the adjustments required for 1st and 2nd half fiscal year reclassifications, respectively. We received only favorable comments on our policy of providing for half-year reclassifications in FY 2007. II. Provisions of the Notice Division B, Title I, section 106 of the Tax Relief and Health Care Act of 2006 (Pub. L. 109-432) extends any geographic reclassification that was set to expire on March 31, 2007 by 6 months until September 30, 2007. Consistent with the mid-year manner in which we originally implemented section 508 (Pub. L. 108-173) in FY 2005, we will not alter previously announced wage indices or geographic reclassifications for hospitals whose reclassifications are not extended by section 106. Such hospitals will continue to receive the wage indices and reclassifications previously announced in the October 11, 2006 IPPS **Federal Register** notice (71 FR 59885) (or any corrections to such notice). Also, consistent with the mid-year implementation of section 508, we have made no changes to the budget neutrality adjustments applied to the standardized amounts previously announced. Also, as with the section 508 reclassifications, the 6-month extension applies to both hospital inpatient and outpatient department services. However, because the Congress limited the extensions available under section 106 to a 6-month period, for hospital outpatient department services and payment under OPPS, a hospital that has a geographic reclassification extended from March 31, 2007 to September 30, 2007 will revert to its previously scheduled April 1st reclassification or its home area wage index from October 1, 2007 to December 31, 2007. As discussed in the previous paragraph, the OPPS wage index received for October 1 through December 31, 2007 will not be affected by the section 106 extension. We have instructed the Medicare Administrative Contractors
(MAC)for the affected providers to continue any geographic reclassifications that were set to expire on March 31, 2007 through September 30, 2007. As described in section I of this Notice, for FY 2007, we allowed some reclassifications to take effect for only half of the fiscal year, and we calculated separate wage indices for the first and second halves of the year for the areas affected by such reclassifications. Hospitals receiving a section 508 reclassification receive the wage index for reclassified hospitals, when such a wage index applies. Because there may be two separate wage indices for hospitals for the first and second halves of the year, a small number of hospitals whose reclassifications are being extended under section 106 will receive the April 1-September 30, 2007 wage index (that is, the wage index value for the second half of the year). Thus, even if these hospitals are reclassified to the same area as in the first half of the year, the hospitals may see a change in their wage indices (see Tables 4A-2, 4B-2, and 4C-2 further corrected on January 5, 2007 (72 FR 569) and March xx, 2007 (72 FR XXX) for a listing of areas where the wage index is changing between the 1st and 2nd half of the fiscal year). We believe such a change is appropriate given section 106's focus on extending the actual geographic reclassification, and not the specific wage index assignment, for the additional 6 months. When applying section 508, we required each hospital to submit a request in writing by February 15, 2004, to the Medicare Geographic Classification Review Board (MGCRB), with a copy to CMS. CMS will neither require nor accept written requests for the extension required by section 106, since that section simply provides a 6-month continuation for any reclassification set to expire March 31, 2007. Thus, for example, hospitals that were not reclassified under section 508 should not send written requests to the MGCRB requesting section 106 extensions. Providers affected by section 106 are listed below: Provider No. Wage index 4/1/2007- 9/30/2007 010150 0.8371 020008 1.2183 050494 1.4116 050549 1.4116 060075 1.0877 070001 1.2730 070005 1.2730 070010 1.3113 070016 1.2730 070017 1.2730 070019 1.2730 070022 1.2730 070028 1.3113 070031 1.2730 070036 1.2930 070039 1.2730 160040 0.8708 160064 0.9701 160067 0.8708 160110 0.8708 220046 1.1343 230003 1.0797 230004 1.0797 230013 1.0602 230019 1.0602 230020 1.0440 230024 1.0440 230029 1.0602 230036 1.0602 230038 1.0797 230053 1.0440 230059 1.0797 230066 1.0797 230071 1.0602 230072 1.0797 230089 1.0440 230097 1.0797 230104 1.0440 230106 1.0797 230119 1.0440 230130 1.0602 230135 1.0440 230146 1.0440 230151 1.0602 230165 1.0440 230174 1.0797 230176 1.0440 230207 1.0602 230223 1.0602 230236 1.0797 230254 1.0602 230269 1.0602 230270 1.0440 230273 1.0440 230277 1.0602 250002 0.8461 250122 0.8461 270023 0.8956 270032 0.8956 270057 0.8956 310021 1.3113 310028 1.3113 310051 1.3113 310060 1.3113 310115 1.3113 310120 1.3113 330049 1.3113 330106 1.4779 330126 1.3113 330135 1.3113 330205 1.3113 330209 1.2730 330264 1.2730 340002 0.9413 350002 0.8367 350003 0.8367 350006 0.8367 350010 0.8367 350014 0.8367 350015 0.8367 350017 0.8367 350030 0.8367 380090 1.1162 390001 0.9990 390003 0.9990 390045* 0.9990 390054 0.9942 390072 0.9990 390095 0.9990 390119 0.9990 390137 0.9990 390169 0.9990 390185 0.9942 390192 0.9990 390237 0.9990 390270 0.9942 430005 0.8708 430015 0.9238 430048 0.9238 430060 0.9238 430064 0.9238 430077 0.9238 430091 0.9238 450010 0.8794 450072 1.0094 450591 1.0094 470003 1.1343 490001 0.8600 530015 1.0060 * This hospital is assigned a wage index value under a special exceptions policy (69 FR 49105). III. Regulatory Impact Statement We have examined the impact of this notice using the requirements of Executive Order 12866 (September 1993, Regulatory Planning and Review), and Executive Order 13132. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis
(RIA)must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This notice implements a statutory provision that would increase payments to hospitals by less than $100 million and is therefore not a major rule. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Again, although we do not consider this notice to be a rule subject to notice and comment rulemaking, we note that this notice does not impose any costs on State or local governments. Therefore, the requirements of Executive Order 13132 would not be applicable. Section 106 of the Tax Relief and Health Care Act of 2006 extends any geographic reclassification that was set to expire on March 31, 2007 by six months until September 30, 2007. We estimate the impact of this provision will be to increase payments to hospitals by $80 million. In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget. Authority: Section 106 of Public Law 109-432. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: March 8, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-5298 Filed 3-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-4083-NR] Medicare Program; Applicability of Part 405 Medicare Appeals Council Own Motion Review Provisions to the Part 423 Medicare Prescription Drug (Part D) Appeals Process AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of CMS Ruling. SUMMARY: This notice announces a CMS Ruling that establishes a process for own motion review of Medicare Prescription Drug Program (Part D) cases by the Medicare Appeals Council. FOR FURTHER INFORMATION CONTACT: Arrah Tabe-Bedward,
(410)786-7129 or Kathryn McCann Smith,
(410)786-7623. SUPPLEMENTARY INFORMATION: The CMS Acting Administrator signed Ruling CMS-4083-NR on March 15, 2007. The text of the CMS Ruling is as follows: Implementation of a Process for Own Motion Review of Part D Cases by the Medicare Appeals Council *Summary:* This Ruling establishes a process, consistent with the current Medicare fee-for-service
(FFS)appeals rules in title 42 of the Code of Federal Regulations, part 405, subpart I, for own motion review of Part D cases by the Medicare Appeals Council. This Ruling is effective on the date the Acting Administrator signs the Ruling. *Citations:* Sections 1852(g), 1860D-4(g)-(h), and 1869 of the Social Security Act (42 U.S.C. 1395w-22, 1395w-104 and 1395ff). I. Background on Part D Appeals Sections 1860D-4(g) and
(h)of the Social Security Act (the Act) and the implementing regulations at 42 CFR part 423, subpart M, establish a Part D enrollee's right to appeal an adverse coverage determination made by a Part D plan sponsor (“plan sponsor”), as defined at 42 CFR 423.4, that results in the denial of prescription drug coverage the enrollee believes he or she is entitled to receive under the Part D program. This includes a plan sponsor's decision not to provide or pay for a Part D drug, failure to provide a coverage determination in a timely manner when a delay would adversely affect the enrollee's health, a decision concerning a tiering or non-formulary exceptions request, and a decision on the amount of cost sharing for a drug. The appeals process establishes that enrollees who are dissatisfied with a coverage determination have the right to request that the plan sponsor conduct a redetermination of its coverage determination. The enrollee then has the right to request a reconsideration by the Part D independent review entity
(IRE)if the enrollee is dissatisfied with the plan sponsor's redetermination. If the enrollee is dissatisfied with the Part D IRE's decision, and the amount in controversy
(AIC)requirement is satisfied, the enrollee has the right to request an administrative law judge
(ALJ)hearing. An enrollee who is dissatisfied with the ALJ's decision has the right to file a request for review with the Medicare Appeals Council (MAC). If the enrollee is dissatisfied with the MAC's decision and the AIC requirement is satisfied, the enrollee has the right to file a civil action in Federal district court. II. Background on MAC Own Motion Review Authority Section 1860D-4(h) of the Act provides that plan sponsors follow appeals procedures in § 1852(g)(5) of the Act that are similar to those applicable to Medicare Advantage
(MA)organizations for Part C appeals. Section 1860D-4(h) is silent with respect to own motion review by the MAC. Section 1852(g)(5) provides that enrollees in MA plans who are dissatisfied with determinations regarding their Part C benefits are entitled, if they meet the amount in controversy requirement, to a hearing before the Secretary to the same extent as is provided in § 205(b) of the Act and judicial review of the Secretary's final decision as provided in § 205(g) of the Act. Section 1869(b)(1)(A) of the Act, which sets forth the requirements for FFS appeals, contains similar language to that set forth in § 1852(g)(5) and also refers to § 205(b) and (g). Again, these sections of the Act do not discuss own motion review by the MAC. These statutory concepts are reflected in the Part D regulations at 42 CFR part 423, subpart M and the Part C regulations at 42 CFR part 422, subpart M. The Part D regulations state that, unless otherwise provided, the Part C regulations regarding appeals will apply to Part D appeals “to the extent they are appropriate.” 42 CFR 423.562(c). The Part D regulations regarding MAC review do not provide any guidance on own motion review and, instead, at § 423.620, explicitly state that the regulations in part 422, subpart M, regarding MAC review apply to Part D appeals “to the extent applicable.” The Part C regulations governing appeals at the ALJ and MAC levels provide that adjudicators apply the FFS appeals procedures in 42 CFR part 405 “to the extent that they are appropriate.” 42 CFR 422.562(d). Like the Part D regulations, the Part C regulations governing MAC review are silent on own motion review and state that the FFS regulations “regarding MAC review apply to matters addressed by this subpart to the extent that they are appropriate.” 42 CFR 422.608. Therefore, because there is no guidance on own motion review by the MAC in the existing Part C and Part D statutory and regulatory frameworks, we look to the FFS regulations. This Ruling is intended to establish the process for own motion review of Part D cases by the MAC using the process established under the FFS regulations, as appropriate. This Ruling does not limit the authority of the Secretary to issue future rulemaking or guidance documents addressing Part D appeals issues, including the MAC's own motion review authority. III. MAC Own Motion Review Under Part 405 and Under This Ruling We believe that it is appropriate to provide a process for making own motion referrals to the MAC for Part D appeals so that there is a means for seeking MAC review of ALJ decisions that may warrant review. Based on the existing statutory and regulatory frameworks, and for the limited purpose of this Ruling, we look to the FFS appeals process for MAC own motion review set out in 42 CFR part 405, subpart I to assist in developing this process and determining
(1)who may refer cases to the MAC,
(2)the standards of referral and review, and
(3)other procedural requirements. A. Who May Refer Part D Cases to the MAC for Own Motion Review Under 42 CFR 405.1110(a), the MAC may decide on its own motion to review a decision or dismissal by an ALJ. In addition, CMS or its contractors may refer a case to the MAC for consideration under this own motion authority if the referral is made anytime within 60 days after the date of an ALJ's decision or dismissal. Section 1860D-4(h)(1) of the Act establishes that only a “Part D eligible individual shall be entitled to bring such an appeal.” Moreover, existing regulations do not provide plan sponsors with the ability to bring an appeal or afford plan sponsors party status to an appeal. Thus, plan sponsors do not have a direct right of appeal to the MAC. Similarly, the existing Part D statute and regulations do not explicitly allow either CMS or its contractors to participate in or be parties to ALJ hearings. For purposes of this Ruling, we believe it is appropriate for the MAC to decide on its own motion to review a decision or dismissal by an ALJ. In addition, we believe that it is appropriate that only CMS or the Part D IRE make referrals to the MAC for own motion review. As a procedural matter and for efficiency, we expect that most of the referrals will be made through the Part D IRE, because it is the entity responsible for monitoring plan effectuation of favorable decisions and serves as a repository for all completed Part D ALJ cases and associated files. The Part D IRE has neither a business nor a financial interest in the outcome of a case. As such, the Part D IRE is generally in the best position to objectively examine whether a particular case meets the standard for referral. While the process established by this Ruling does not permit a plan sponsor to refer a Part D case to the MAC for own motion review, plan sponsors will continue to have the opportunity to communicate with the Part D IRE about cases that may warrant such a referral. Thus, we consider it appropriate, and consistent with part 405, subpart I, to allow the MAC to review an ALJ decision or dismissal on its own motion, and to allow only CMS or the Part D IRE to refer cases to the MAC to consider review under its own motion authority. B. Standards for Referral and Review of Part D Cases for Own Motion Review by the MAC With respect to the standards for referral of cases, the regulations at § 405.1110 distinguish between cases in which CMS or its contractor participated or appeared as a party in the appeal at the ALJ level and cases in which CMS or its contractor did not participate. Where CMS or its contractor did not participate or appear as a party, § 405.1110(b)(1) and (c)(2) establish that CMS or any of its contractors may refer a case to the MAC if the ALJ decision or dismissal contains an error of law material to the outcome of the claim or presents a broad policy or procedural issue that may affect the public interest. In addition to the referral standards that apply when CMS or its contractor did not participate or appear as a party, for cases in which CMS or its contractor participated or was a party at the ALJ level, § 405.1110(b)(1)(ii) and (c)(1) provide that CMS or its contractor may also refer cases for own motion review by the MAC if, in CMS’ view, the ALJ decision or dismissal is not supported by the preponderance of evidence in the record or the ALJ abused his or her discretion. Since CMS and its contractor do not have explicit authority under the existing statutes and regulations to participate in or be parties to ALJ hearings in Part D cases, we believe it is appropriate and consistent with part 405, subpart I, to allow CMS or the Part D IRE to refer Part D cases to the MAC to consider review under its own motion authority based on the standards for referral that apply when CMS or its contractor did not participate in the ALJ proceedings or appear as a party. Similar to how § 405.1110 sets forth different referral standards depending on whether or not CMS or its contractor participate in the ALJ hearing, the regulations provide differing standards for review. Section 405.1110(c)(1) provides that when a referral is made in instances where CMS or its contractor participated or appeared as a party, the MAC exercises its own motion authority if there is an error of law material to the outcome of the case, an abuse of discretion by the ALJ, the decision is not consistent with the preponderance of the evidence of record, or there is a broad policy or procedural issue that may affect the public interest. In deciding whether to accept review under this standard, the MAC will limit its consideration of the ALJ's action to those exceptions raised by CMS. Section 405.1110(c)(2) provides that when referral is made in instances where CMS or its contractor did not participate or appear as a party, the MAC will accept review if the decision or dismissal contains an error of law material to the outcome of the case, or presents a broad policy or procedural issue that may affect the public interest. In deciding whether to accept review, the MAC will limit its consideration of the ALJ's action to those exceptions raised by CMS. As previously noted, since neither the Part D statute nor the current Part D regulations explicitly allow a Part D plan sponsor, CMS, or a CMS contractor to participate in or be parties to appeals at the ALJ level, we consider it appropriate to implement the standard of referral and review in § 405.1110 that applies when CMS and its contractor do not participate in or are not parties to the ALJ hearing. Accordingly, under this Ruling, CMS or the Part D IRE may refer a Part D case to the MAC and the MAC will accept review of a Part D case if the ALJ's decision or dismissal contains an error of law material to the outcome of the case or presents a broad policy or procedural issue that may affect the general public interest. In deciding whether to accept review, the MAC will limit its consideration of the ALJ's action to those exceptions raised by CMS or the Part D IRE. C. Other Issues Regarding MAC Own Motion Review of Part D Cases For the most part, the other provisions set forth under § 405.1110 apply appropriately to Part D cases. The requirements related to the 60-day time frame for filing the written referral and for providing notice to other interested parties set forth in § 405.1110(b)(2) are processes that are appropriate to apply to Part D cases. See also 42 CFR 405.1110(a). Written referrals must state the reasons why CMS or its contractors believe the MAC must review the case on its own motion. CMS or its contractors will send a copy of its referral to all parties to the ALJ's action and to the ALJ. Similarly, the requirements in § 405.1110(b)(2) regarding the filing of exceptions to the referral by submitting written comments to the MAC within 20 days of the referral notice, and sending such comments to CMS, appropriately apply to Part D cases. We also believe it is appropriate to apply to Part D cases those requirements in § 405.1110(d) regarding the MAC's action. This provision states that if the MAC decides to review a decision or dismissal on its own motion, it will mail the results of its action to all the parties to the hearing and to CMS if it is not already a party to the hearing. The notice of the referral in § 405.1110(b)(2) requires that the enrollee will be notified that the ALJ's decision may not be the final action in the case. If the MAC accepts review, it may adopt, modify, or reverse the decision or dismissal, may remand the case to an ALJ for further proceedings or may dismiss a hearing request. The MAC must issue its action no later than 90 days after receipt of the CMS referral, unless the 90-day period has been extended as provided in 405 CFR subpart I. The MAC may not, however, issue its action before the 20-day comment period has expired, unless it determines that the agency's referral does not provide a basis for reviewing the case. If the MAC does not act within the applicable adjudication deadline, the ALJ's decision or dismissal remains the final action in the case. We believe it is appropriate to apply these procedures to Part D cases that the MAC reviews on its own motion. As described in this section, the provisions in § 405.1110 are procedural rules that apply appropriately to Part D appeals. Further, applying these regulatory processes to Part D appeals does not conflict with existing Part D requirements. Authority: Sections 1852, 1860D-4(g)-(h), and 1869 of the Social Security Act (42 U.S.C. 1395w-22, 1395w-104 and 1395ff). (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: March 15, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-5304 Filed 3-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1481-N3] Medicare Program; Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group
(TAG)Meeting—May 3-4, 2007 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. SUMMARY: This notice announces the sixth meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. The primary purpose of the sixth meeting is to enable the EMTALA TAG to hear additional testimony and further consider written responses from medical societies and other organizations on specific issues considered by the EMTALA TAG at previous meetings. The public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor. DATES: *Meeting Date:* The meetings of the EMTALA TAG announced in this notice are as follows: Thursday, May 3, 2007, 9 a.m. to 5 p.m. Friday, May 4, 2007, 9 a.m. to 5 p.m. *Registration Deadline:* All individuals must register in order to attend this meeting. Individuals who wish to attend the meeting but do not wish to present testimony must register by April 26, 2007. Individuals who wish to attend the meeting and to present their testimony must register by April 12, 2007 and must submit copies of their testimony in writing by April 19, 2007. See section III for more detailed registration instructions. *Comment Deadline:* Written comments/statements to be presented to the EMTALA TAG must be received by April 19, 2007. *Special Accommodations:* Individuals requiring sign-language interpretation or other special accommodations should send a request for these services to Eric Ruiz by 5 p.m. by April 19, 2007 at the address listed below. ADDRESSES: *Meeting Address:* The EMTALA TAG meeting will be held in Room 705a of the Hubert Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20001. *Mailing and E-mail Addresses for Inquiries or Comments:* Inquiries or comments regarding this meeting may be sent to—Eric Ruiz, Division of Acute Care, Centers for Medicare & Medicaid Services, Mail Stop C4-08-06, 7500 Security Boulevard, Baltimore, MD 21244-1850. Inquiries or comments may also be e-mailed to *Eric.Ruiz@cms.hhs.gov* or *EMTALATAG@cms.hhs.gov.* *Web Site Address for Additional Information:* For additional information on the EMTALA TAG meeting agenda topics, updated activities, and to obtain Charter copies, please search our Internet Web site at ( *http://www.cms.hhs.gov/faca/07_emtalatag.asp* ). FOR FURTHER INFORMATION CONTACT: Eric Ruiz,
(410)786-0247. George Morey,
(410)786-4653. SUPPLEMENTARY INFORMATION: I. Background Sections 1866(a)(1)(I), 1866(a)(1)(N), and 1867 of the Social Security Act (the Act) impose specific obligations on Medicare-participating hospitals that offer emergency services. These obligations concern individuals who come to a hospital emergency department and request or have a request made on their behalf for examination or treatment for a medical condition. The Emergency Medical Treatment and Labor Act (EMTALA) applies to all these individuals, regardless of whether or not they are beneficiaries of any program under the Act. Section 1867 of the Act sets forth requirements for medical screening examinations for medical conditions, as well as necessary stabilizing treatment or appropriate transfer. Regulations implementing the EMTALA legislation are set forth at 42 CFR 489.20(l), (m), (q), and
(r)and § 489.24. Section 945 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)(Pub. L. 108-173), mandates that the Secretary establish a Technical Advisory Group
(TAG)for advice concerning issues related to EMTALA regulations and implementation. Section 945 of the MMA specifies that the EMTALA TAG— • Shall review the EMTALA regulations; • May provide advice and recommendations to the Secretary concerning these regulations and their application to hospitals and physicians; • Shall solicit comments and recommendations from hospitals, physicians, and the public regarding implementation of such regulations; and • May disseminate information concerning the application of these regulations to hospitals, physicians, and the public. The EMTALA TAG, as chartered under section 945 of the MMA, is also governed by the provisions of the Federal Advisory Committee Act
(FACA)(5 U.S.C. Appendix 2) for the selection of members and the conduct of all meetings. In the May 28, 2004 **Federal Register** (69 FR 30654), we specified the statutory requirements regarding the charter, general responsibilities, and structure of the EMTALA TAG. That notice also solicited nominations for members based on the statutory requirements for the EMTALA TAG. In the August 27, 2004 **Federal Register** (69 FR 52699), we solicited nominations again for members in two categories (patient representatives and a State survey agency representative) for which no nominations were received in response to the May 28, 2004 **Federal Register** notice. In the March 15, 2005 **Federal Register** (70 FR 12691), we announced the inaugural meeting of the EMTALA TAG and the membership selection. In the May 18, 2005 **Federal Register** (70 FR 28541), the September 23, 2005 **Federal Register** (70 FR 55903), the April 7, 2006 **Federal Register** (71 FR 17888), and the September 29, 2006 **Federal Register** (71 FR 57543), we announced the second, third, fourth, and fifth meetings of the EMTALA TAG, respectively, with a purpose to hear public testimony and consider written responses from medical societies and other organizations on specific issues considered by the EMTALA TAG at its previous meetings. The EMTALA TAG has established the following three subcommittees: • *On-Call Subcommittee* (Chairperson, John Kusske, M.D.) charged with reviewing the testimony and other materials provided to the TAG to identify some specific issues related to on-call requirements. • *Action Subcommittee* (Chairperson, Julie Nelson, J.D.) charged with identifying issues other than on-call issues. • *Framework Subcommittee* (Chairperson, Charlotte Yeh, M.D.) charged with clarifying the historical context and conceptual basis for the TAGs recommendations and developing a document for review and approval by the TAG. II. Meeting Format, Agenda, and Presentation Topics A. Meeting Format The initial portion of the meeting, which will convene at 9 a.m. on May 3, will involve opening remarks and a limited period of public testimony on issues related to EMTALA and its implementation. TAG members will have the opportunity to ask questions, prioritize the topics presented, and to conduct other necessary business. At the conclusion of each day's meeting, to the extent that time is available and at the discretion of the Chairperson, the public will be permitted a reasonable time to comment on issues being considered by the TAG. B. Tentative Meeting Agenda The tentative agenda for the EMTALA TAG meetings is as follows: Day 1 Convenes at 9 a.m. • Welcome, Call to Order, and Opening Remarks. • Administrative and Housekeeping Issues. • Public Testimony on Issues Related to EMTALA and its Implementation. • Subcommittee Reports. • Public Comment. Day 2 Convenes at 9 a.m. • Subcommittee Reports. • Public Comment. C. Public Presentations Only individuals who register and submit written testimony as specified in the Registration section of this notice will be considered registered presenters. The time allotted for each presentation will be approximately 5 minutes and will be based on the number of registered presenters. Presenters will speak in their assigned order. If registered presenters are not given an opportunity to speak because of time restrictions, we will accept and present their written testimony to the TAG members. Time permitting, comments from other participants (individuals who are not registered presenters) may be heard after the scheduled testimonies. If there are individuals who cannot attend the meeting but wish to submit comments/statements regarding issues related to the EMTALA TAG, we will accept and present their written comments/statements at the meeting if their comments/statements are received by postal mail or e-mail at the address listed in the ADDRESSES section of this notice by April 19, 2007. III. Registration Instructions The Center for Medicare Management of CMS is coordinating meeting registration. While there is no registration fee, all individuals must register to attend due to limited seating. As specified in the DATES section of this notice, individuals who wish to attend the meeting but do not plan to present testimony must register by April 26, 2007. Individuals who would like both to attend and to present testimony on issues relating to the EMTALA TAG must register by April 12, 2007 and must state specifically in their registration request that they wish to present testimony for EMTALA TAG consideration. A copy of the presenter's written testimony must be received by CMS at the address specified in the ADDRESSES section of this notice by April 19, 2007. You may register by e-mail to Marianne Myers at *Marianne.Myers@cms.hhs.gov* , by fax to the attention of Marianne Myers at
(410)786-0681, or by telephone at
(410)786-5962. All registration requests must include your name, name of the organization (if applicable), address, telephone and fax numbers, e-mail address (if available). Individuals will receive a registration confirmation with instructions for your arrival at the Hubert Humphrey Building. If seating capacity has been reached, registrants will be notified that the meeting has reached capacity. All registrants are asked to arrive at the Hubert Humphrey Building no later than 20 minutes before the scheduled starting time of each meeting session they wish to attend. IV. Security Information Since this meeting will be held in a Federal government building, Federal security measures are applicable. As noted above, in planning your arrival time, we recommend allowing additional time to clear security. In order to gain access to the building, participants must bring a government-issued photo identification such as a driver's license or a passport and a copy of your registration information for the meeting. Access may be denied to persons without proper identification. All persons entering the building must pass through a metal detector. In addition, all items brought to CMS, whether personal or for the purpose of demonstration or to support a presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a presentation. Authority: Section 945 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: March 16, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-5329 Filed 3-22-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0101] Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft document for the public, FDA advisory committee members, and FDA staff entitled “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees” dated March 2007. This draft guidance describes the factors and analyses that should be used in considering whether an advisory committee member has a potential conflict of interest and whether participation in a meeting is appropriate. This guidance is intended to help the public, FDA advisory committee members, and FDA staff to understand and implement FDA policy in applying the applicable statutory and regulatory requirements. This draft guidance, when finalized, will replace the guidance document entitled “FDA Waiver Criteria 2000.” DATES: Submit written or electronic comments on the draft guidance by May 21, 2007. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Policy (HF-11), Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit phone requests to 800-835-4709 or 301-827-1800. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Jill Hartzler Warner, Office of Policy and Planning (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3370. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document, entitled “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff; Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees,” dated March 2007. FDA's advisory committees provide independent and expert advice on scientific, technical, and policy matters related to the development and evaluation of products regulated by FDA. FDA is committed to strictly adhering to the laws and regulations governing the process for selecting advisory committee members. FDA for many years has screened, prior to each meeting, all advisory committee members who are special government employees or regular government employees, to determine whether the potential for a financial conflict of interest exists. The agency may grant a waiver to allow an individual to participate in a meeting when statutory criteria are met; for example, when the need for the individual's services outweighs the potential for a conflict of interest created by the financial interest involved. FDA administers several laws and regulations that govern conflict of interest determinations; these laws are not entirely consistent and set out different standards. FDA's Waiver Criteria 2000 guidance, which this draft guidance would replace, attempted to comprehensively address the complex set of variables that can be applied in reaching a determination about an individual advisory committee participant. However, because of its complexity and discretionary elements, FDA staff found it difficult to achieve consistent results that the public could readily understand. As part of FDA's recent internal assessment of its advisory committee process, the agency has targeted its assessment of potential conflicts of interest and granting of waivers as an area that needs improvement. This draft guidance will implement a more stringent approach for considering eligibility for participation in FDA advisory committee meetings. The purpose of this draft guidance is to simplify and streamline the process by which FDA considers meeting participation, increase the transparency, clarity, and consistency of the process, and enhance public trust in this important function. We welcome comments on the draft guidance and specifically seek comment on
(1)whether the draft approach, due to its stringency, could unduly restrict eligibility of needed experts for advisory committee meetings,
(2)whether the $50,000 figure generally employed as the maximum amount for disqualifying financial interests, after applying certain exemptions, is appropriate or, alternatively, whether a different figure (higher or lower) should be used, and
(3)whether and what additional examples should be provided for the steps described in this draft guidance for determining conflicts of interest and eligibility for participating in an advisory committee meeting. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance represents the agency's current thinking on procedures for considering conflict of interest and eligibility for participation in FDA advisory committees. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at: *http://www.fda.gov/opacom/morechoices/industry/guidedc.htm* Dated: March 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-1459 Filed 3-21-07; 1:43 pm]
Connectionstraces to 9
23 references not yet in our index
  • Pub. L. 92-463
  • 42 CFR 483.160
  • 42 CFR 483
  • 42 CFR 422.624
  • 42 CFR 422.626
  • 42 CFR 447.53
  • 42 CFR 430.10-430
  • 42 CFR 423
  • Pub. L. 106-113
  • 41 CFR 102
  • 42 CFR 486.306
  • 42 CFR 482.45
  • 42 CFR 486.308(e)
  • Pub. L. 108-173
  • Pub. L. 109-432
  • 42 CFR 423.4
  • 42 CFR 422
  • 42 CFR 423.562(c)
  • 42 CFR 405
  • 42 CFR 422.562(d)
  • 42 CFR 422.608
  • 42 CFR 405.1110(a)
  • 42 CFR 489.20(l)
Citation graph
cites case law
Notices
Notice
U.S.C.§ 1395l
U.S.C.§ 217a
U.S.C.§ 273
U.S.C.§ 1320b–8
U.S.C.§ 553
Fed. Reg.Notices
Fed. Reg.Proposed Rules
U.S.C.§ 1395w–22
C.F.R.§ 10.115
Pub. L.Pub. L. 92-463
Cite42 CFR 483.160
Cite42 CFR 483
Cites 32 · showing 12Cited by 0 across 0 sources
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