A sampling of the high priority, significant actions to be undertaken in the next fiscal year or two (as part of the strategies articulated in the HHS Strategic Plan) to accomplish the strategic objectives are based on key Departmental priorities which fall into five general themes as indicated below:

Preventing Disease and Illness and Protecting America’s Consumers (Goal 1 and Objective 2.2):

Consumer health and safety is a major concern for the public and for HHS.  Consumers are inundated each year with increasing amounts of new ingestible products and ingredients.  Providing consumers with information about these products is of key importance for reducing health threats.  Key actions to help reduce major threats to the health and well-being of Americans include:

• Establishing current good manufacturing practices for dietary supplements and ingredients (a proposed rule). (Objectives 2.2 and 5.4)
• Improving egg safety by requiring that shell eggs be produced using measures designed to prevent Salmonella Enteritidis from contaminating eggs on the farm during production (a proposed rule). (Objectives 2.2 and 5.4)

Improving the Department’s Ability to Respond to Emergencies and Disasters (Objective 2.1):

HHS is responsible for directing and coordinating the medical and public health response to terrorism, natural disasters, major accidents, and other events that can result in mass casualties.  Timely and well-focused responses to such events are key to limiting death and injury.  The Department and its partners must be able to react quickly, and tailor responses to the specific emergency without being encumbered by unnecessary or counter-productive activities.

Upcoming actions designed to help ensure that HHS has appropriate authority and flexibility to address emergencies and disasters include:

• Establishing registration requirements for all facilities engaged in manufacturing, processing, packaging, or holding food for U.S. consumption (a proposed rule). (Objectives 2.2 and 5.4)
• Requiring the establishment and maintenance of certain records regarding food products (proposed rule).
• Authorizing the Food and Drug Administration to prevent the release or shipment of food if it is determined that such acts would present a serious health threat (proposed rule).
• Clarifying the exception from the general requirement providing for an exception from the general requirement for informed consent for use of investigational diagnostic devices during a potential terrorism event or other public health emergency (proposed rule). (Objective 2.1)
• Establishing a process for people infected with or exposed to communicable diseases to be quarantined, including surveillance of quarantined persons; also, requiring airlines, etc. to maintain passenger manifests for a minimum period of time. (Objective 2.1)

Reducing Medical Errors and Enhancing Patient Safety (Objectives 2.2, 5.1, 5.3, and 5.4):

Medical errors and other patient safety risks have been the subject of many recent studies and reports, and reducing these risks is a priority for HHS.  Actions related to reducing medical errors include:

• Requiring that human drug products have a scanable bar code that will reduce medication errors (a proposed rule – FY 2003); the code would contain information about the product, and when used with bar code scanners and computer equipment, would help reduce the number of medication errors. (Objectives 5.1 and 5.5)
• Enhancing and making more timely the safety reporting on drugs and biologics by amending the expedited and periodic safety reporting regulations for human drugs and biological products to revise definitions and reporting formats as recommended by the International Conference on Harmonisation (a proposed rule).
• Requiring improvements in the format and content requirements of the “professional” labeling of drug products which would include a section containing highlights of prescribing information and a section containing an index to prescribing information, enabling health care practitioners to prescribe drugs more safely (a final rule – final action expected). (Objectives 2.2 and 5.3)
• Requiring that blood establishments prepare and follow written procedures for appropriate action when it is determined that blood and blood components pose an increased risk for transmitting hepatitis C virus infection because they have been collected from a donor who, at a later date, tested reactive for evidence of the virus.  The HIV lookback regulations will also be amended for consistency. (final rule).  (Objectives 2.2 and 5.4)
• Requiring a toll-free number on labels for human drugs for reporting adverse events.  (Objectives 2.2 and 5.4)
• Strengthening requirements that hospitals have in place, including policies and procedures to assess and improve the quality of the medical care they provide (a final rule).

Quality of and Access to Health Care (Goals 3 and 5):

• Establishing conditions for coverage for organ procurement organizations to be certified to receive payment from Medicare and Medicaid for organ procurement costs, and to be designated for a specific geographic service area. (Objective 3.5)
• Establishing a prospective payment system for psychiatric hospitals. (Objective 3.3)
• Revising the methodology for determining the average wholesale price of prescription drugs covered by Medicare incident to physicians’ services (in order to lower the costs).  (Objective 3.3)
• Implementing revised hospital quality review conditions and criteria to ensure they focus primarily on actual quality of care provided to patients, and the outcomes of that care, rather than on procedural compliance.

Reducing Unnecessary and Counter-Productive Regulations (Objective 8.7):

HHS’ Advisory Committee on Regulatory Reform addressed the Department’s priority of reducing regulatory burden on consumers, beneficiaries, health care providers, and other stakeholders.  In addition to conducting many public meetings with stakeholders, the Committee reviewed an array of Departmental regulations, with the goal of identifying reforms that would maintain or enhance program performance while reducing burdens and costs.  Proposed ways to accomplish this include a) clarifying and simplifying regulations in order to remove impediments to high quality care and safe medical products, b) eliminating unnecessary paperwork, c) improving the quality and timeliness of information for consumers, beneficiaries, and providers, d) increasing flexibility in federal health programs, e) promoting collaboration and coordination among and between HHS agencies and other public and private stakeholders, and f) recognizing the significant role for technology that can improve the delivery of health care and speed administrative functions.  Specific and more immediate Department actions include:

• Reducing unnecessary process and procedural requirements and focusing on the patient and the results of care provided to end stage renal disease patients, including establishment of new infection control guidelines, updated water quality standards, and care planning. (FY 2004)
• Clarifying the responsibilities of Medicare hospitals that provide emergency room treatment.
• Implementing a standard identifier to identify health plans that process and pay certain electronic health care transactions for administrative simplification; also, jointly with Department of Commerce, adopting standards for the security of certain electronically individually-identifiable health information (Objectives 8.5 and 8.7).

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