Federal Regulation

The federal government's Food and Drug Administration has long played a role in protecting consumers through regulation. The agency is responsible for ensuring that medicines, medical devices, blood supplies, and certain experimental medical treatments (e.g., gene therapy) are safe and effective, and that foods and cosmetics are truthfully labeled and not harmful. It is only since the late 1980s, however, that the federal government has entered the broader arena of regulating healthcare providers and health insurers, traditionally the bailiwick of state and local governments. It has done so principally to address bioethical issues.

Some policies have been enacted to compensate for perceived inadequacies in state regulation, such as measures in the Omnibus Budget Reconciliation Act of 1987 established to reform the quality of nursing home care. Others have responded to new developments in thinking about ethical patient care. For instance, in the context of growing concerns about protecting patient autonomy, the federal Patient Self-Determination Act was enacted in 1990. It requires healthcare organizations to immediately inform new patients of their rights to refuse medical and surgical treatment and to execute written legal documents, called advance directives, regarding their preferences in this regard.

In 1996 alone, the federal government enacted three regulatory laws intended to protect consumers by addressing ethical issues. The Mental Health Parity Act of 1996 responded to inequities in coverage for mental healthcare by requiring that if a group insurance plan covers mental health, the annual and lifetime benefits available must be equivalent to those available for medical and surgical services. The Newborns' and Mothers' Health Protection Act of 1996 addressed perceived issues in quality of care by mandating minimum inpatient stays for mothers and their newborns following deliveries and caesarean sections. And the Health Insurance Portability and Accountability Act of 1996 made obtaining group health insurance easier for individuals with pre-existing health problems and disabilities or previous illnesses, and for those who lost their coverage because of changing jobs or job termination.

The role of the federal government in addressing ethical issues through regulatory policy is likely to expand continually. Technological and biomedical discoveries and innovations inevitably generate questions of fairness and equity that lend themselves to the possibility of government intervention, such as whether genetic tests should be used as screens to exclude applicants for private insurance, whether or in what circumstances stem cell research should be allowed, or how scarce societal resources (e.g., organs for transplantation) should be distributed.

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Anxiety and Depression 101

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