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

The Food and Drug Administration (FDA) is proposing to reclassify the topical oxygen chamber for extremities (TOCE) from class III (premarket approval) into class II (special controls). The device is intended to surround a patient's limb and apply humidified oxygen to aid healing of chronic skin ulcers such as bedsores. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the draft guidance document that the agency proposes to use as a special control for the device.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Medicare Provider Analysis and Review (MEDPAR), System No. 09-70-0009.'' Notice for this system was published at 65 Federal Register (FR) 50548 (August 18, 2000). CMS is reorganizing its databases because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173) provisions and the large volume of information the Agency collects to administer the Medicare program. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained the system. The new assigned identifying number for this system should read: System No. 09-70-0514. We propose to establish a new routine use to provide disclosure of data to hospitals that may be entitled to disproportionate share hospital payments. This new routine use will implement the disclosure provisions of Section 951 of the MMA. Section 951 will provide hospitals with a data set that will span the 2 Federal Fiscal Years that encompass the hospital's cost reporting period. This modification will carry out the purposes of the MEDPAR and enable hospitals to calculate and verify their Supplemental Security Income (SSI) ratio without the need for additional processing on the part of CMS. This new routine use will be published at routine use number 3. We are modifying the language in some of the remaining routine uses to provide clarity to CMS' intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by recent reorganizations and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system is to collect and maintain information for all services rendered during Medicare beneficiary stays in an inpatient hospital and/or Skilled Nursing Facilities (SNF), so as to enable CMS and its contractors to facilitate research on the quality and effectiveness of care provided, update annual hospital Inpatient Prospective Payment System (IPPS) rates, and to calculate Supplemental Security Income (SSI) ratios for hospitals that are paid under the hospital IPPS and serve a disproportionate share of low-income patients (hospitals that serve a disproportionate share of low-income patients are entitled to increased reimbursement under the IPPS). Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) provide system data to a hospital that has an appeal properly pending before the Provider Reimbursement Review Board (PRRB) or before an intermediary; (3) provide system data when all requirements have been met to a hospital that may be entitled to disproportioned share hospital payments and makes a request in accordance with section 951 of the MMA; (4) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (5) support constituent requests made to a Congressional representative; (6) support litigation involving the agency; (7) facilitate research on the quality and effectiveness of care provided; and (8) combat fraud and abuse in certain Federally-funded health benefits programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the tenth meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on May 4, 2006, and from 9 a.m. to 3 p.m. on May 5, 2006, at the Rockville DoubleTree Hotel, 1750 Rockville Pike, Rockville, Maryland 20852. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

This proposed rule sets forth new requirements for hospital discharge notices under both original Medicare and the Medicare Advantage program. This proposed rule would require hospitals to comply with a two-step notice process when discharging patients from the hospital level of care that is similar to the notice requirements regarding service terminations applicable to home health agencies, skilled nursing facilities, comprehensive outpatient rehabilitation facilities, and hospices.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice establishes a computer matching agreement between CMS and the Department of Defense (DoD). We have provided background information about the proposed matching program in the SUPPLEMENTARY INFORMATION section below. The Privacy Act requires that CMS provide an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See DATES section below for comment period.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The supplemental ANADA provides for a new container size, a 15-gram bottle, from which gentamicin sulfate, betamethasone valerate, clotrimazole ointment may be dispensed for the treatment of acute and chronic canine otitis externa.