Department of Health and Human Services January 6, 2006 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Medicare Bariatric Surgery System (MBSS), System No. 09-70-0570.'' National coverage determinations (NCDs) are determinations made by the Secretary of HHS with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act (the Act) section 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Moreover, with limited exceptions, the expenses incurred for items or services must be ``reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,'' section 1862(a)(1)(A). CMS has determined that the evidence is adequate to conclude that bariatric surgery is reasonable and necessary in several patient groups where certain criteria for these patients have been met. The reasonable and necessary determination requires that patients meet the MBSS criteria set forth in the decision memorandum and are consistent with the trials discussed. Bariatric surgery is reasonable and necessary only when facilities performing the surgery have full accreditation based on standards equivalent to or exceeding the CMS minimum standards. Collection of data elements related to bariatric surgery allows that determination to be made. The purpose of this system is to provide reimbursement for bariatric surgery, and assist in the collection of data on patients receiving bariatric surgery, for a data collection process to assure patient safety and protection, and to determine that the bariatric surgery is reasonable and necessary. 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) 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 Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) 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.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Citizens' Health Care Working Group (the Working Group) mandated by section 1014 of the Medicare Modernization Act.

The Food and Drug Administration (FDA) published a notice in the Federal Register of December 14, 2005 (70 FR 74020) announcing the availability of a guidance document entitled, ``Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006.'' The guidance document provided guidance to FDA and the food industry about when and how businesses may request the agency to consider enforcement discretion for the use, on products introduced into interstate commerce on or after the January 1, 2006, effective date for the trans fat labeling final rule, of some or all existing label stock that does not declare trans fat labeling in compliance with the final rule. This is to notify all interested persons of an addendum to that guidance.