Health Care Law

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Health Care Law


Regulation of healthcare in America continues to be a divisive topic. The regulatory process is complex, impacting healthcare payers, providers, and consumers. Polar views on market dynamics and the right to healthcare contribute to the quagmire. Healthcare regulations thus far have been made in piecemeal fashion. As the issues of cost, quality, and access to care grow with the aging of the U.S. citizenry, Federal change may be in store. In this paper we will analyze and evaluate the US legislation regarding the rights of patients to access care and financial health solutions.

Regulation and Policy - Differences

Regulation and policy are different. According to the Merriam-Webster dictionary, a policy is a high-level overall plan embracing the general goals and acceptable procedures especially of a governmental body and a regulation is a rule or order issued by an executive authority or regulatory agency of a government and having the force of law.The former is designed to facilitate decision-making and the latter is designed to control and govern the decisions.

Need for Regulation and Policy

Regulations are needed for three primary purposes: (1) to promote adherence to standards, (2) to manage and simplify market complexity, and (3) to fill gaps due to private sector inaction.

First, regulations and policies are used to control behavior of certain groups and hold them accountable to set standards. This control is especially necessary in a capitalist market, where the interests of business and consumers conflict. In the case of pharmaceuticals, manufacturers are held to high manufacturing standards. For healthcare providers, association-set standards of care and medical guidelines establish treatment protocols. For insurers and sites of care, Federal, State, and industry-affiliated organizations monitor facilities and processes. Without regulation, variation would naturally exist.

Second, complexity and competing interests invite regulation. The complexity of players in the U.S. healthcare system and the myriad insurance provisions and financing sources led government to simplify Medicare, for example. Medicare recipients were confused by the multitude of overlapping options for supplemental Medicare coverage. Moreover, in many cases, one entity can more effectively make decisions to benefit the whole than numerous decision-making bodies.

Third, as the evolution of Food and Drug Administration (FDA) policies exhibits, governmental regulation can arise to fill private sector gaps. For example, environmental protection policies serve to protect natural resources, the water supply, and air quality from wastes of business and industry. Federal support of research through the NIH provides resources that otherwise would not be provided. Importantly, healthcare coverage provided by Medicaid and Medicare enables targeted, underserved populations such as the poor and elderly to access needed services.

Reasons for Regulation - Regulators

The main reason for the introduction of regulation on food, drugs, and cosmetics is protection of consumers. Early health regulation dealt with the quality of products on the market. Pieces of legislation meant to protect the citizens from misbranded and adultered foods and drugs and misleading or false claims were enacted in the early 1900s. The death of 107 people in 1937, from a poisonous additive in Elixir of Sulfanilimide, dramatized the ...
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