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

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

This proposed rule would implement competitive bidding programs for certain covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) throughout the United States in accordance with sections 1847(a) and (b) of the Social Security Act (the Act). These programs would change the way that Medicare pays for these items under Part B of the Medicare program by utilizing bids submitted by DMEPOS suppliers to establish applicable payment amounts. We would phase in these programs over several years. This proposed rule would also detail requirements for CMS approved accreditation organizations that will be applying quality standards for all DMEPOS suppliers, including DMEPOS suppliers that participate in the DMEPOS competitive bidding program. In addition, this rule proposes a new fee schedule for home dialysis supplies and equipment still paid on a reasonable charge basis. This proposed rule would also clarify our policy on the scope of the statutory eyeglass coverage exclusion. We are proposing to specify in regulations that the eyeglass exclusion encompasses all devices that use lenses to aid vision or provide magnification of images for impaired vision. Further, this proposed rule would implement a revised methodology for calculating fee schedule amounts for new DMEPOS items.