• Click Here to Get Working Papers on Facility Regulations

There are numerous regulations that affect health facilities. We have attempted to limit our focus to those having the greatest potential impact on health costs, recognizing that not all regulations affect all facilities.

We include in this series of papers as access regulations, the Emergency Medical Treatment and Active Labor Act (EMTALA), hospital community service requirements, hospital uncompensated care pools, hospital conversion regulations and limited English proficiency requirements. The provision of transplant-related data was intended to increase access to transplant services, we include it later under cost regulation as part of organ transplant regulation. We also examined an extensive literature on non-profit health facilities on grounds that EMTALA relies on a “stick” to expand access to emergency care whereas NFP tax exemption might be viewed as using a “carrot” to achieve this and other similar ends.

Additionally as part of cost regulations, we include fraud and abuse regulations. We also include medical records regulation and pharmaceutical price regulation, as well as organ transplant regulation, certificate of need, and hospital rate-setting. Finally, under other cost-related health facilities regulations we include the Patient Self-Determination Act of 1990 and hospital discharge data systems.

As part of quality regulations, we include hospital accreditation and licensure and state accreditation and licensure, nursing home accreditation and licensure and accreditation and licensure for all other health facilities. As well, we include peer review, and other quality-related facilities regulations such as FDA regulation of blood banks, blood-borne pathogen requirements imposed by OSHA and health outcomes reporting systems mandated by states.

Note that the medical tort system is discussed as a completely separate category on grounds that it affects facilities, professionals and even insurance plans to some extent.

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• Click Here to Get Working Papers on Health Profession Regulations

Although some aspects of facilities regulation are directed at changing the behavior of health professionals (e.g., surgical outcomes reporting systems), we have included these under facilities since the burden of compliance typically is borne by the facility rather than health professionals directly. Thus, in terms of sheer numbers, there are fewer regulations that we have tracked on the health professionals side, but in reality health professionals as a group are probably regulated just as much as facilities are.

Under access, we include only Medicare assignment rules.

Under costs, we include federal and state regulations related to fraud and abuse, federal and state regulation of medical records as they relate to offices/clinics for physicians, dentists and other health professionals, and Medicare graduate medical education payments.

Under quality, we include Medicare Conditions of Participation as they relate to physician offices, the National Practitioner Databank, professional accreditation and licensure (e.g., medical practice acts), commercial limits on the practice of medicine (including corporate practice of medicine regulations and advertising restrictions imposed by the FTC and states), and limitations on hours worked by medical residents.

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• Click Here to Get Working Papers on Insurance Regulations

Health insurance regulation represents an arena of enormous activity at both the federal and state level.

Under access, we include the HMO Act of 1973, anti-discrimination restrictions, and several types of mandated health coverage. These include the employer mandate enacted in Hawaii in 1974, continuation of coverage requirements, and mandated health benefits. We also include mandated provider laws and so-called person mandates. We also include a variety of federal and state insurance market reforms including small group insurance reforms, individual market reforms, community rating, health alliances (both voluntary and mandatory), and Health Care Portability and Accountability Act (HIPAA, 1996) insurance reforms. Finally, we include health plan conversion regulations and high risk pools.

Under costs, we include the Employee Retirement Income Security Act of 1974 (ERISA), two key provisions of HIPAA, Medicare as a secondary payer rules passed in 1980, Medigap minimum standards enacted in 1990 and general health insurance/HMO regulation. We also include premium taxes on grounds that states have used these not purely for revenue generation, but also to alter the structure of the industry to some extent.

Under quality, we include Medicare Plus Choice conditions of participation and a variety of managed care regulations. While all arguably are intended to improve patient quality, we distinguish between those focused on professional rights, on grounds that they are aimed at countering the market power exercise of MCOs vis-à-vis individual providers. The remainder are more focused on patients.

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• Click Here to Get Working Paper on FDA Pharmaceutical Regulations

The economic impact of the 1962 Drug Amendments was already included in the Hahn and Hird (1990) cost of regulation study, so we simply updated this properly calculated deadweight loss estimate and added to it formal cost and benefit estimates for all major FDA rules during the past decade and the estimated impact of FDA regulation on mortality.

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• Click Here to Get Working Papers on the Medical Tort System

This working paper was based upon recent synthesis of evidence regarding the medical tort system as such as that prepared by the Joint Economic Committee in May 2003.

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• Click Here to Get Appendix Materials for the Working Papers Series

This section contains accessory support information for the working papers series.

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