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Statement of Need: In Executive Order 13563, the President recognized the importance of a streamlined, effective, efficient regulatory framework designed to promote economic growth, innovation, job creation, and competitiveness. To achieve a more robust and effective regulatory framework, the President has directed each executive agency to establish a plan for ongoing retrospective review of existing significant regulations to identify those rules that can be eliminated as obsolete, unnecessary, burdensome, or counterproductive or that can be modified to be more effective, efficient, flexible, and streamlined. This rule continues our direct response to the President's instructions in Executive Order 13563 by reducing outmoded or unnecessarily burdensome rules, and thereby increasing the ability of health care entities to devote resources to providing high quality patient care.

Summary of the Legal Basis: The provisions that are included in this rule are necessary to implement the requirements of Executive Order 13563, "Improving Regulations and Regulatory Review."

Alternatives: To date, nearly 90 specific reforms have been identified and scheduled for action. These reforms impact hospitals, physicians, home health agencies, ambulance providers, clinical labs, skilled nursing facilities, intermediate care facilities, managed care plans, Medicare Advantage organizations, and States. Many of these reforms will be included in rules that relate to particular categories of regulations or types of providers. Other reforms are being implemented without the need for regulations. This rule includes reforms that do not fit directly in other rules scheduled for publication.

Anticipated Costs and Benefits: This rule makes several changes that create measurable monetary savings for providers and suppliers, while others create less tangible savings of time and administrative burden. We anticipate that the provider industry and health professionals will welcome the changes and reductions in burden. We also expect that health professionals will experience increased efficiencies and resources to appropriately devote to improving patient care, increasing accessibility to care, and reducing associated health care costs.

Risks: If this regulation is not published, outdated and obsolete regulations would remain in place, thereby violating the Executive Order. Proposals to remove excessively burdensome requirements and increased efficiencies in patient care would not be achieved.