Health Law and Regulations

Government takes part in regulating the healthcare industry for the same reason as it participates in overseeing other industries. The national government of the USA plays a significant role in organizing, financing, controlling, and delivering healthcare. The state and local health departments are also important contributors to the mentioned purposes. In many instances, the task of healthcare policy makers at all levels includes providing the patients with qualified, wide accessible, and affordable care. A balance of all three characteristics would guarantee well functioning of the healthcare system. However, it is a challenging task to support them at the same level. Thus, for example, higher quality care supposes more expenses. If the cots are cut, it may lead to restricted access or lower quality of care. By contrast, broader availability carries a considerable price tag (Field, 2006, p.4). Paying equal attention to these goals should be the highest priority to all healthcare regulatory program makers. Nowadays, the functions of healthcare regulatory agencies involve monitoring practitioners and facilities, enforcing legal compliance, and spreading information on industry changes. These missions can be fulfilled only providing that efficient laws on medicine exist. The healthcare system regulation is very complex nowadays and faces considerable overall challenges. Despite the fact that conflicts in regulating this industry are apparent, the healthcare policy makers should follow the concept of compromise in enhancing quality, moderating costs pressures, and opening access. The description and examples given in this paper show how contradictory can be the impact that laws and regulations have on providers and clinics.

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It is a well-known fact that the healthcare is one of the most heavily regulated branches in the USA. Even a well-experienced lawyer can be shocked at the multiplicity of the local, federal, or state agencies involved in controlling, providing, or paying for medical services and goods. The highest body that oversees healthcare is the federal government, which acts as a regulator of commerce between states and a supervisor over spending money for the welfare of American people. In other words, this agency has an authority to manage the manufacture and sale of pharmaceutical drugs and medical devices, as well as create benefit programs, such as social insurance. The federal government can influence local activities indirectly. This phenomenon can be seen in the examples of Medicare and Medicaid, which are federal programs aimed at providing payments for disabled and elderly people and assisting in healthcare access for the poor. Thus, hospitals receive money for supporting the aforesaid programs on condition of compliance with federal regulations. Federal authorities involved in healthcare implicate myriad agencies that are set under the Department of Health and Human Services (HHS). This governmental body administers conducting of scientific and medical research, providing financial assistance to indigent individuals, promoting healthcare and advocacy services, and enforcing regulations and laws concerning human services. HHS manages over 300 different programs and administers the majority of grant funding plans. There are currently ten major constituents within HHS (Field, 2006, p.11). The key agencies functioning under HHS are the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS). The other bodies include the Indian Health Service (HIS), the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SASHA), the Agency for Healthcare Research and Quality (AHAQ), the Administration on Aging, and the Administration for Children and Families. Some of them, such as the FDA and the NIF, are responsible for food safety and pharmaceutical products and fund biomedical research respectively; others, like the CDC, focus national attention on environmental health, infectious diseases, occupational safety, and educational measures. The AHAQ, for example, supports research on health services. There is a variety of other departments including private ones, which are engaged in regulating process. Each agency regulates a specific area, like hospitals, physicians, healthcare products, healthcare finance, public health, and funding of research (Pope, Gagne, & Kesselheim, 2010, p. 2). Due to the multiplicity of oversight bodies, the organizations or individuals subject to regulation must address many authorities for guidance (Field, 2008). If a person wants to become a practicing healthcare provider, he or she will have to go through an array of bureaucratic regulatory hurdles. Primarily, a potential doctor must get lectures at a medical school that is accredited by private organization and take an examination administered by another nongovernmental body. Then he or she must receive licensure from a state medical board, pass the hospital residency, which is governed and funded by the federal program of Medicare, obtain certification from a private board, and get employed at a hospital that operates as either a public or private entity. The other case that demonstrates the complexity of healthcare regulatory system in the USA is the marketing of new pharmaceutical products. Thus, any company that produces drugs must protect its invention by a patent received from the federal Patent and Trademark Office (PTO). The next step is to get permission from the federal Food and Drug Administration (FDA) for conducting clinical tests. The FDA carries resolutions based on the reviews of private scientists. Then, the manufacturer must attain a place for its product in the form of private pharmacy companies, which administer reimbursement plans (Field, 2008). Finally, the product cannot be sold unless physicians and pharmacists, who are subjected to licensure and other regulatory requirements, prescribe and dispense it. These examples depict correlation between regulatory governmental and private bodies.

A detailed discussion of the two agencies can help understand their role in regulating the healthcare industry. Thus, the CDC is the premier public healthcare agency of the country, which works to ensure healthy people in a healthy environment. It focuses on protecting public health through preventing diseases, disabilities, and defects. The CDC has to focus national attention on environmental health, infectious disease, food borne pathogens, occupational safety, health promotion, and educational measures in order to improve the health of American citizens. The CDC in its activity relies on the Public Health Law Program (PHLP), the mission of which is to improve the public’s health through law. The goals of PHLP are to enhance the legal preparedness of the healthcare system in order to resist threats and diseases. They can be realized through strengthening the competencies of health professionals, attorneys, and other practitioners to apply law to public health, and by spreading information about public health law within different communities (Goodman et al., 2006). Through creating the “Public Health Emergency Law,” the CDC has stimulated state and local partners to empower practitioners to use law and strengthen legal preparedness capacities. The CDC’s influence on healthcare system can be seen in the creation of the Public Health Law Group in California. This group has drafted a legally annotated practice guide for providers to declare communicable disease control (Goodman et al., 2006). In addition, the CDC makes a significant contribution to improving healthcare through generating conference that comprises practitioners of the classical healthcare disciplines, law enforcement professionals and emergency management, educators, judges, researchers, and others. Interrelations and experience exchange among the community members can help disseminate law and profession-oriented information to hospitals and doctors. Another witness of governmental healthcare impact on healthcare entities with the help of the CDC is the Hospital Seismic Safety Act, which directs California hospitals to withstand strong shakes. According to this law, all at-risk hospitals had to replace or retrofit their buildings by 2013. Fines, penalties, and sanctions for non-compliance could amount to multiples of the underlying costs of complying with the law (Robichaux, 2008). That is why the healthcare facilities look for a relief from the costly proposition of seismic upgrading. Recently, the government has passed a new law that delays the terms of hospitals’ meeting seismic safety standards until 2030. As experts state, it will help save billions of dollars to California hospitals.

The next illustration depicts the influence of governmental entities on clinics, hospitals, or providers. Therefore, the Agency for Healthcare Research and Quality is another important formation functioning as a part of HHS. Its destination is to promote researches, which would help improve the quality of public health. In its work, the agency uses a classification of quality indicators that define the healthcare quality standards and monitor whether the provider meets those norms. These indicators include four subgroups, each of which monitors a different subset of healthcare quality. Thus, the Prevention Quality Indicator (PQI) inspects occurrences of return hospital admissions and thereby enhances the quality of outpatient care. The next indicator, known as In-Patient Quality Indicator (IQI), serves to qualify patient’s care inside the hospital. It is used while studying the rates of mortality caused by insufficient care in a particular clinic. Patient Safety Indicators (PSI) point to the level of care through detecting the cases of mortality caused by outdated hospital machinery (Rose, 2010). Pediatric Quality Indicators are applied for the same goals as previously mentioned ones, but they concern the child population. The results of conducted researches based on the noted indicators should be sent to the HHS site. The AHRQ, however, is not authorized to penalize facilities who get low rates, but, as an inspection, it can stimulate them to work better. Along with the use of quality care indicators, the AHRQ reports the results of its research at different resources in order to be accessible for healthcare providers. It also assists in creating software or other systems required to handle information about patients and care. Consequently, it can be stated that the performance of the AHRQ has a direct impact on both hospitals and providers.

To conclude, it is worth to note that the governmental agencies play an important role in increasing the quality of the American healthcare system. The federal government is responsible for funding, which is distributed from the state government to the local departments. The HHS, as a governmental body, administers not only financing, but also conducting researches, promoting healthcare services, enforcing laws referred to human services, and many other fields of the health industry. The agencies working under the HHS have different and in some cases overlapping destinations. Their activity sometimes appears to be too restrictive and excessively controlled. Further reforming of the healthcare system should include the ways of constructing a more systematized, comprehensible, and serviceable system.