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ua14no94 DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HUD)...
<DOC> DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Statement of Regulatory Priorities This statement of regulatory priorities is in two parts. Part I describes the overall regulatory priorities of the Department. Part II describes these priorities by agency, in greater detail. I. Overall Priorities The Department of Health and Human Services, the ``People's Department,'' provides direct services or assistance to one of every five Americans. With emphasis on children, the elderly, disabled persons, the poor and others who are most vulnerable, HHS is the Federal Government's principal agency for protecting health and providing essential human services to Americans. HHS activities are striking in their variety, ranging from the largest programs in Government (Social Security, Medicare, Medicaid) to some of the smallest. HHS responsibilities encompass a wide spectrum including improving infant health; providing care for the elderly; gathering basic national health and welfare statistics; providing job training, health clinics, and Head Start services; conducting health research at the National Institutes of Health; and regulating food and drug products that account for some 25 cents of every dollar spent by American consumers. The Department's regulatory priorities reflect our broad strategic goals. These key goals include: <bullet> Transforming the welfare system in this country from a system of dependency to a system of transition to work; <bullet> Improving and protecting the health of our citizens, especially the Nation's most vulnerable populations; <bullet>Investing in the future of our Nation's children and youth; <bullet> Increasing the independence and self-sufficiency of the elderly and persons with disabilities; and <bullet> Improving the management of our programs and delivery of services to our customers. Many of our significant regulatory initiatives address one or more of these Department-wide goals. For example, new Head Start regulations will not only strengthen the existing program as an investment in our nation's children, but will also implement the new component for infants and toddlers through performance standards. Because of the importance of HHS's regulatory responsibilities, we are emphasizing the principles of Executive Order 12866 which include regulating only where required by statute or to meet a compelling public need, fully considering the costs and benefits of regulatory alternatives, increasing consultation with affected publics, and reducing regulatory burden. HHS is committed to substantial reforms of our existing regulations to reduce burden on those we regulate while effectively meeting the health and human services responsibilities of this Department. To focus our efforts on those items in most need of revisions, we have asked the public for recommendations through a request published in the Federal Register on January 20, 1994. We continue to seek recommendations from the public. Early consultation with those parties affected by rulemaking is critical to developing workable regulations. HHS will use a number of innovative approaches as we work on developing the most effective strategies for consultation with State and local governments and the wide variety of other groups and individuals affected by regulations issued by this Department. One approach that we plan to use for the first time in the upcoming year is negotiated rulemaking. This process will bring HHS together with external interests who would be significantly affected by a new rule to reach consensus through open discussions on some or all issues under consideration before a rule is formally published as a notice of proposed rulemaking. HHS is taking a new approach to our relationship with State, local, and tribal governments. We are listening to officials of other levels of government concerned about the imposition of unfunded mandates and other significant changes on the way they must operate. Pursuant to Executive Order 12875, ``Enhancing the Intergovernmental Partnership,'' HHS is committed to avoiding where possible imposition of mandates-- funded, and particularly unfunded--and to consulting with appropriate levels of government as early as possible in the development of policies and regulations affecting them. We are carrying out our decisionmaking and consultation with a full appreciation of State, local, and tribal governments as our partners in serving the public. One example of our efforts is the Medicaid regulation on home and community-based care which was published in July 1994. We worked closely with States to craft less burdensome waiver requirements that will give States an opportunity to improve and expand these essential community-based services to provide home care for more individuals and to avoid unnecessary placement in nursing homes or other health care institutions. There are additional samples of regulations meeting both HHS strategic goals and E.O. 12866 objectives. Under the Mammography Quality standards Act, the Food and Drug Administration is implementing a major initiative to upgrade the quality of mammography services. Higher quality services will help increase the number of women whose cancers are detected early and contribute directly to improving the health of women. Other PHS agencies are working on selected regulations that will also contribute to improving the Nation's health, such as regulations related to State enforcement of laws against selling tobacco products to minors. Reengineering the Social Security Administration's disability insurance claims process will enable us to dramatically reduce serious backlogs and provide better service. The current process and procedures have not changed significantly since the 1950's. Proposed changes would affect types and locations of personnel in State agencies that serve as agents for the program, and adjudicative standards. The Health Care Financing Administration is reviewing existing Medicare and Medicaid quality standards, known as ``conditions of participation,'' for health care facilities such as hospitals, home health agencies, and dialysis facilities to identify opportunities to reform these standards to emphasize performance, to make them more customer-centered, and to reduce burden on regulated entities. A number of other regulations to simplify management of HCFA programs and increase program integrity guarantees are also under development. As a final example of the relationship of our regulatory initiatives to these goals, just this spring our new food labeling standards became effective, providing the American consumer with clear, useable, and understandable nutrition information. This empowers the consumer with the information needed to improve diet and health, and thus reduces his or her risk of certain diseases, including heart disease and cancer. II. Agency Plans Virtually all HHS regulations are issued by a handful of agencies within the Department. Descriptions of priorities for these are as follows. Health Care Financing Administration (HCFA) HCFA is striving to reduce unnecessary burdens that the Medicare and Medicaid programs have imposed on beneficiary populations, all levels of government, and the medical provider community. HCFA is also extending flexibility to the States where it will foster improved and less burdensome operations and facilitate State reform activities. In order to provide the most responsive and effective services possible, HCFA is conducting rulemakings in an open manner, consulting with and obtaining early and continuous input from the various levels of government, as well as representatives of advocacy and provider organizations. HCFA is working with State and local governments through a continuous and ongoing consultation process in the development of Medicaid regulations. For example, regularly scheduled meetings are held with technical advisory groups that include HCFA and State Medicaid representatives. Regular meetings and consultations are also held by the ``Camden Yards Group'' that includes representation from the State Medicaid Directors' Association, the American Public Welfare Association, the National Governors' Association, and the Conference of State Legislators. Under this cooperative structure, HCFA can ensure maximum flexibility to State Medicaid programs. Each major Medicaid regulation is being developed with extensive involvement from this representative structure to assure effectiveness and economy. Examples include: a proposed rule to clarify for States the process for making ``findings'' concerning the payment for inpatient hospital and long-term care facility services; a notice that will facilitate implementation of the Department's childhood immunization program; a rule that will make good on the President's commitment to the National Governors' Association to simplify the home and community-based services waiver process; and, a rule that will ensure the effective delivery of services under the early periodic screening, diagnostic, and treatment (known as EPSDT) program. These reforms will contribute to improving access and meeting the health needs of children, particularly disadvantaged and minority children. In accordance with the combined themes of reducing unnecessary burden, improving quality of care, and involving input from a full range of interests, HCFA is developing improved Medicare regulations that will govern conditions of participation for home health agencies and hospitals, and conditions of coverage for the payment of end-stage renal disease. Existing regulations in these areas are unnecessarily burdensome, outdated, and process oriented. They will be replaced with more universally applicable provisions that are patient/outcome oriented and driven by meaningful data to better ensure healthy outcomes for aged patients and those with disabilities. In developing these regulations, HCFA has met, and is continuing to meet, with a variety of provider and consumer representatives. HCFA is also developing quality assurance regulations for nursing homes. The agency is considering an enforcement regulation that will use patient health status measures as benchmarks for determining whether nursing facilities are in compliance with Medicare and Medicaid participation requirements. For example, where deficiencies that do not harm people are involved, the focus will be on corrective measures. Conversely, for health and safety violations involving potential or actual harm to residents/patients, punitive measures can be expected, such as denial of payment, civil monetary penalties, and exclusion from the Medicare/Medicaid programs. By establishing enforcement remedies that realistically relate to the effects on patient health and safety, the rule will encourage facilities to achieve the highest level of health for the aged and disabled patients in these facilities. In the area of fiscal responsibility, regulations are being developed to implement the statutory prohibition against patient referrals by physicians to health service entities (e.g., clinical laboratories, home health agencies, physical therapists, etc.) with which the physician has a financial interest or relationship. These regulations are significant because they address the concern that such referral relationships involve a potential for conflict of interest resulting in unnecessary services for Medicare patients and unnecessary costs to the Medicare program. Several of HCFA's reform efforts are particularly supportive of the President's directive (in Executive Order 12866) to take burden- reducing regulatory actions, and the Secretary's goal of significantly improving HHS management and customer service. Indeed, our efforts are already bearing fruit. For example, in March 1994 HCFA published a regulation that replaced the requirement for physicians to provide hospitals annually with a signed acknowledgement concerning penalties for misrepresenting certain information with a one-time signing requirement at the time a physician is initially granted hospital admitting privileges. One major medical association characterized this change as one that will alleviate the ``hassle factor'' for physicians and an important step toward restoring mutual trust between the Federal Government and the medical profession. Public Health Service (PHS) Including the Food and Drug Administration (FDA) The PHS agencies (which, other than the Food and Drug Administration, have minimal regulatory responsibilities) are working on selected regulatory initiatives that improve individual program areas and support the Secretary's goals. These include regulations on organ procurement, State enforcement of laws against selling tobacco products to minors, reducing potential conflicts of interest in biomedical research, improving respirators used in the workplace, and increasing tribal government responsibilities for managing health care programs. Through the Food and Drug Administration, HHS has undertaken a number of new regulatory initiatives to speed the development of new drugs to treat serious diseases, particularly the development of drugs to treat and prevent HIV infection, one of the nation's highest health priorities. In support of this goal, FDA funds the National Task Force on AIDS Drug Development, which was established by the Secretary of Health and Human Services, and provides further support in terms of agency expertise in science and medical ethics. FDA has also acted to encourage labeling of prescription drugs for AIDS and other serious illnesses with dosing information for pediatric use, so that these therapies can be readily used to treat children. Empowerment of the individual to participate in his or her own health care is also a high priority. FDA is developing regulatory initiatives to transform drug labeling into a readily understandable source of information for individuals who are not health professionals, which would help prevent the substantial waste and harm that occurs when patients do not understand how to use therapeutic drugs properly. The agency is completing implementation of the new food labeling at this time in a pioneering effort to provide consumers with information that enables them to use food products in a manner consistent with a healthy life style. Consistent with the Vice President's recommendation for a new food safety program to reform regulatory oversight of the nation's food supply, FDA is working to replace its current oversight strategy with a cost-effective, state-of-the-art strategy. The agency's proposed new approach for oversight of seafood is based on the system of Hazard Analysis Critical Control Points (HACCP), and FDA plans to work with the food industry to explore expanding HACCP to other components of the food supply. FDA has embarked on a number of initiatives to improve and focus on women's health. The agency is moving to implement the Mammography Quality Standards Act rapidly to facilitate the detection of breast cancer and is establishing an Office of Women's Health to provide leadership and monitoring in areas such as the application of the agency's revised clinical trial guidelines, the development of new contraceptives and products to protect women against sexually transmitted diseases, and the safety of cosmetics. The United States leads the world in development of new technologies, and FDA has given priority to products of important new technologies, such as gene and somatic cell therapy and food plants genetically altered through use of recombinant DNA techniques, striking a balance between regulation and reliance on the private sector in a manner that encourages the rapid evolution of these technologies, their continued adaptation to health-related uses, and the building of public confidence in them. To help speed important new drugs and medical devices to patients, the agency has also developed new programs, such as user fees for drug approvals. In order to facilitate the electronic submission of marketing applications for such products, FDA plans to propose steps by which legally binding electronic signatures may be affixed to such applications, thus validating them. FDA will address concerns about the integrity of clinical data submitted to support marketing approval of new therapies by proposing the disclosure by clinical investigators of potentially biasing financial holdings. Finally, FDA has undertaken the review of a large number of regulations for burdensome provisions that can and should be eliminated. As part of this process, the agency will work to assure that these regulations are effective, consistent, sensible, and understandable. Regulations that will come under scrutiny include a major portion of the general biologics regulations; the blood and blood products regulations; the regulations governing the investigation and review of new animal drugs; and the good manufacturing practice regulations for medical devices. Social Security Administration (SSA) The Social Security Administration continuously reviews its regulations to ensure that its policies constitute a properly integrated program that conforms to the statutes, court decisions, public needs, and to the principles of economical, efficient, and effective administration. SSA has three major initiatives under way. On September 8, 1994, Commissioner Chater issued an agency Disability Process Redesign Plan. Decisions on implementation, including the need for regulations, are not yet final. SSA is continuing a cooperative project with the Internal Revenue Service (IRS) and other government agencies to develop a simplified wage reporting system. Under the proposed system, Federal and State agencies would develop an integrated reporting approach whereby employers would file employment and wage-related information with a single processing entity. The processing entity would, in turn, be responsible for providing the data to Federal, State, and local agencies for which the submitted information was intended. This system would eliminate redundant wage reports and greatly reduce the complexity of wage and tax reporting requirements presently imposed upon employers. SSA is currently evaluating findings and recommendations made by the MITRE Corporation to determine the next step toward implementation. The MITRE Corporation's preliminary economic analysis suggests that employers could save approximately $1 billion a year under the system's full implementation. Findings to date indicate that an agreement would be needed with each participating State to ensure that State needs are adequately met and to reach agreement on necessary cost-sharing arrangements. In addition, SSA is continuing to work with the IRS to coordinate the timing of when employers are required to file wage and tax reports. Currently, employers are required to file Form 941 wage reports by the end of January and Forms W-2/W-3 by the end of February. SSA is
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