Department of Health and Human Services August 2006 – Federal Register Recent Federal Regulation Documents

This proposed rule would address certain provisions of the Deficit Reduction Act of 2005, as well as make other proposed changes to Medicare Part B payment policy. We are proposing these changes to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. This proposed rule also discusses geographic practice cost indices (GPCI) changes; requests for additions to the list of telehealth services; payment for covered outpatient drugs and biologicals; payment for renal dialysis services; policies related to private contracts and opt-out; policies related to bone mass measurement services, independent diagnostic testing facilities, the physician self-referral prohibition; laboratory billing for the technical component (TC) of physician pathology services; the clinical laboratory fee schedule; certification of advanced practice nurses; health information technology, and the health care information transparency initiative.

Under section 1909 of the Social Security Act (the Act), 42 U.S.C. 1396h, the Inspector General of the Department of Health and Human Services is required to determine, in consultation with the Attorney General, whether a State has in effect a law relating to false or fraudulent claims submitted to a State Medicaid program that meets certain enumerated requirements. If the Inspector General determines that a State law meets these requirements, the State medical assistance percentage, with respect to any amounts recovered under a State action brought under such a law, shall be increased by 10 percentage points. This notice sets forth the Inspector General's guidelines for evaluating whether a State law meets the requirements of section 1909 of the Act.

The purpose of the Community Economic Development (CED) grants is to create new employment and business development opportunities for low-income individuals. The Office of Community Services (OCS) awarded a $663,263 CED grant (Grant No. 90EE0720) to Hall Neighborhood House in Bridgeport, Connecticut, on September 29, 2005. Prior to the expenditure of any of the grant funds, the grantee informed OCS in a letter dated April 17, 2006, that it wished to ``relinquish the management and operation of this program effective immediately.'' The letter stated the grantee's ``current financial instability'' as the reason for the action. In an attempt not to lose the benefits for the community that were intended through the CED grant, OCS identified a possible replacement recipient: Action for Bridgeport Community Development, Inc (ABCD). The organization is being considered as a replacement recipient for the following reasons: ABCD is a previously successful CED grantee (grant 90EE0546). ABCD is headquartered approximately a mile and a half from the offices of Hall Neighborhood House (HNH) in Bridgeport, CT and will serve the same community. Also, ABCD and HNH have worked together in the past and reportedly have maintained a good working relationship. ABCD has a significantly sophisticated budget to manage this project effectively. (In 2003, the organization had gross receipts of approximately $20 million.). ABCD was recently selected by the Head Start Bureau to be the successor grantee of HNH's active Head Start grant. ACF Region I Administrator Hugh Galligan speaks highly of the performance of ABCD and has recommended that it be the replacement recipient. OCS has received and reviewed an application from ABCD. Upon finding that the proposed project is significantly similar to the one chosen for funding through HNH, OCS has requested that ABCD be approved as the permanent replacement recipient for Grant No. 90EE0720.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Marketing Act of 1987'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems, and to implement a number of changes made by the Deficit Reduction Act of 2005 (Pub. L. 109-171). In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. We also are setting forth rate-of-increase limits as well as policy changes for hospitals and hospital units excluded from the IPPS that are paid in full or in part on a reasonable cost basis subject to these limits. These changes are applicable to discharges occurring on or after October 1, 2006. In this final rule, we discuss public comments we received on our proposals to refine the diagnosis-related group (DRG) system under the IPPS to better recognize severity of illness among patientsto use a hospital-specific relative value (HSRV) cost center weighting methodology to adjust DRG relative weights; and to implement consolidated severity-adjusted DRGs or alternative severity adjustment methods. Among the other policy changes that we are making are those changes related to: limited revisions of the reclassification of cases to DRGs; the long-term care (LTC)-DRGs and relative weights; the wage data, including the occupational mix data, used to compute the wage index; applications for new technologies and medical services add-on payments; payments to hospitals for the direct and indirect costs of graduate medical education; submission of hospital quality data; payments to sole community hospitals and Medicare-dependent, small rural hospitals; and provisions governing emergency services under the Emergency Medical Treatment and Labor Act of 1986 (EMTALA). We are responding to requested public comments on a number of other issues that include performance-based hospital payments for services and health information technology, as well as how to improve health data transparency for consumers. In addition, we are responding to public comments received on a proposed rule issued in the Federal Register on May 17, 2006 that proposed to revise the methodology for calculating the occupational mix adjustment to the wage index for the FY 2007 hospital inpatient prospective payment system by applying an adjustment to 100 percent of the wage index using new 2006 occupational mix survey data collected from hospitals. We are finalizing two policy documents published in the Federal Register relating to the implementation of the Health Care Infrastructure Improvement Program, a hospital loan program for cancer research, established under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. This final rule also revises the definition of the term ``unit'' to specify the exclusion of units of drugs sold to approved Medicare Competitive Acquisition Program (CAP) vendors for use under the CAP from average sales price (ASP) calculations for a period of up to 3 years, at which time we will reevaluate our policy.

The NTP invites public comments on the proposed review process for the 12th RoC. The proposed review process for the 12th RoC is available on the NTP Web site https://ntp.niehs.nih.gov (select ``Report on Carcinogens'') or by contacting Dr. C.W. Jameson at the address provided below.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry (183) entitled ``Animal Drug User Fees: Fees Exceed Costs Waivers and Reductions.'' The draft guidance explains the procedures FDA expects to use to evaluate waiver requests under the fees exceed costs waiver provision of the Animal Drug User Fee Act of 2003.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Chicago, Illinois'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Chicago, IL. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Chicago, IL, October 23 through 26, 2006, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Monday, October 2, 2006, from 1:30 p.m. to 4 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3d Fl., Conference Room G, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 1:25 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Room G. Contact Person: Tammie Bell, Office of the Commissioner (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0919, e-mail: Tammie.Bell2@fda.hhs.gov, FAX: 301-480-0716. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person by September 25, 2006. If you need special accommodations due to a disability, please contact Tammie Bell at least 7 days in advance.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Blockson Chemical Company (also known as Olin Mathieson), Jolit, Illinois, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to a revision as warranted by the evaluation, is as follows: Facility: Blockson Chemical Company (also known as Olin Mathieson). Location: Joliet, Illinois. Job Titles and/or Job Duties: All workers who worked in Building 55 at the Blockson Chemical Company. Period of Employment: January 1, 1951 to December 31, 1962.

This notice announces the cancellation of the eighth meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.). Canceled Date/Time: August 14, 2006, 1 p.m. to 5 p.m.