Regulations refer to the directives formulated and maintained by a given authority. In healthcare, various regulations exist to ensure efficiency in service delivery. Each regulation that applies to the sector is maintained by a given regulatory agency which is charged with enforcing particular requirements (Hunt, 2014). The regulatory agencies consist of the governmental institutions as well as other private organizations. Some of the regulatory agencies originated as complex systems that have been in the forefront in opposing the actions by the government in controlling the healthcare sector. However, the constitution which is the supreme law of the land gives the government the full authority to control every sector of the economy. The government must play a major role in overseeing the regulations because of their direct effect on the health of the individual citizens.
The regulations play a vital role in the healthcare sector as well as in the insurance coverage of the health care. Every department including but not limited to the medical directors, physicians, pharmaceutical companies, the healthcare facilities, and the healthcare computer infrastructure companies within the healthcare sector is subject to these regulations and their compliance. The regulatory bodies formulating these regulations are important as they protect the public from a range of health risks thus ensuring the welfare of the individuals and the public health (Huberfeld, 2007). The regulatory bodies coordinate to protect and regulate the public health at every given level. The existing healthcare regulations set the required health regulations and standards that are key to ensuring the compliance as well as the provision of safe health care to individuals who access the systems. On the other hand, the regulatory agencies monitor the healthcare practitioners and the facilities in which they are based, promote safety, provide the necessary information on any existing changes within the industry, and ensure every practitioner and facility is compliant with the legal requirements and offers quality services (Walshe, 2003).
The most active agencies in formulating the regulatory on the healthcare sector are the federal, state, and local agencies. These agencies establish the rules and regulations for the industry with a mandatory oversight. However, regulatory agencies such as those for accreditation often require voluntary participation. Nonetheless, the agencies are still vital as they provide the rankings and the quality assurance certificate. The agencies also give additional oversight to ensure the healthcare organizations promote as well as provide effective and efficient health care.
Some of the healthcare regulatory agencies within the United States includes the Office of Health Care Quality (OHCQ), Centers for Medicare and Medicaid (CMS), Health Insurance Portability and Accountability Act (HIPAA), Agency for Healthcare Research and Quality (AHRQ), Joint Commission on Accreditation of Health Care Organizations (JCAHO), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and many others (Silberman & CIark, 2012). The Office of Health Care Quality (OHCQ) is charged with monitoring the quality of care provided to the individuals. The agency also licenses and provides certificates for the healthcare facilities across the country. The agency implements most of the regulations formulated by the state and the federal governments to ensure the minimum standards required in providing health care to the individuals are met. The agency is also responsible for conducting surveys to determine compliance among the existing healthcare facilities. The Office of Health Care Quality (OHCQ) also plays a vital role of educating the healthcare providers within the United States, the consumers of the sector, as well as the stakeholders through the use of presentations, digital media, seminars, conferences, and other materials on the importance of providing efficient healthcare services.
The Centers for Medicare and Medicaid (CMS) is also responsible for the oversight role. The agency oversees most of the healthcare-related regulations. The agency also provides subsidized coverage through its programs such as the Medicare, Medicaid, and the State Children's Health Insurance Program (SCHIP). Medicare targets the disabled, the Medicaid is for the low-income individuals and their families, while the SCHIP program ensures the children under the age of 19. The Centers for Medicare and Medicaid ensures the compliance of the Health Insurance Portability and Accountability Act (HIPAA) which protects the patients from high hospital costs while ensuring better medical care to every individual. The Centers for Medicare and Medicaid agency ensures there is a continuous improvement in the efficiency and effectiveness in the healthcare services provided to the patients.
The United States government also have the Agency for Healthcare Research and Quality (AHRQ) which is tasked with researching the quality of the health care provider, the health care cost, as well as the safety of the patients. This agency is also responsible for ensuring a reduction in medical errors within the healthcare sector. Other regulatory departments such as Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), United States Agency for Toxic Substances and Disease Registry (ATSDR), Environmental Protection Agency (EPA) and many others also exist to oversee various forms of regulations in the healthcare sector. The Centers for Disease Control and Prevention (CDC) has been lauded for its exemplary role in examining and warning the public health of the possible threats that may arise from the infectious diseases. The agency has been in the forefront in monitoring the birth defects, diseases and conditions, disabilities, environmental health, travelers' health, health promotions, preparedness and response, vaccines and immunizations, genetics and genomics, local and international health organizations such as the World Health Organizations in order to control the spread of infectious viruses such as the Ebola virus across the world. The Food and Drug Administration (FDA) has also been at the forefront of control the drug supplies within the country to ensure they are safe and effective for human and animal use. The regulatory body is also in charge of regulating the safety of the food, animal supply, the cosmetics, medical devices, the dietary supplements, the inspection of the restaurants, and the products recalls. The United States Agency for Toxic Substances and Disease Registry (ATSDR) regulatory agency has also brought major impacts in the public health sector by ensuring the effects of the hazardous materials are monitored and kept under control. The body is in charge of educating the public about the HAZMAT risks while involving various organizations and the community members. The Environmental Protection Agency (EPA) is another important body in the healthcare sector. The EPA is a federal agency that protects the health of the humans as well as the environments in which they live through formulating and enforcing regulations which are then passed by the Congress.
The implementation of these regulations within the healthcare sector requires regulatory frameworks which are key to ensure compliance with the basic standards. The regulatory frameworks are vital as they provide the models through which the regulations are enacted. These frameworks are always developed within specific areas of interest which is the healthcare in this case. The government, as well as other regulatory agencies, rely on these formulated frameworks to develop and enact regulations within the given sectors. Every framework is often developed with an end goal. In the case of health care, the end goal of every framework is always to ensure higher quality and effective care services to the public. Nonetheless, according to Stoddart & Evans (2017), the introduction of these regulations within the healthcare sector has only led to poor quality services to the patients. In the study Stoddart & Evans (2017) insinuates that the majority of the physicians have only experienced frustrations in regards to the regulations. Some of the regulations tend to be complex and expensive contrary to their intended purpose of making the healthcare sector effective and more efficient. The study by Hall et al. (2018) also indicates that the record systems that have been introduced by these regulations are by far complex for the physicians and has only acted as a barrier in the delivery of effective care. The federal regulations that have constantly been on the rise have only made the health record keeping more complex than ever before requiring additional training of the staff while leading to layoffs in some sectors.
In the healthcare sector, these regulations have brought challenges such as the HIPAA and Data Breaches, False Claims and Whistleblower, Anti-Kickback and Physician-Hospital Issues, Co-Management Arrangements, Impact of Stark Law on Physician-Hospital Relationships, Antitrust Issues, and Changes in Reimbursement, Recovery Audit Contractors, Employment and Labor Issues, Tax-Exempt Hospitals and Compliance Requirements, among others. On HIPAA and Data Breaches, the use of the electronic devices in the storage of the patients' data which is a requirement within the regulations has facilitated easier data breaches (Polsky et al., 2014). Today, the electronic data breaches is a significant problem across sectors. Thus, the problem can prove to be very devastating in the healthcare industry due to the required ethical standards in handling the patients' data within the sector. The states within the United States have responded to this challenge by formulating their laws that would help combat healthcare data breach. These laws are unique depending on the state in question. The difference in the laws comes in the definitions on particulars such as the personal information, the notifications for the breaches, and the charges in cases of data breach and non-compliancy.
The healthcare regulations have also brought about the false claims and the whistleblower suits. The formulated False Claim Act covers various types of fraud that involves the federally funded programs such as the Medicare and the Medicaid. Under the False Claim Act, the health care providers and practitioners stand to be prosecuted for actions that may result in fraudulent claims. The primary activity that inspired the formulation of the act is the presentation of the false information knowingly by the healthcare providers to the federal government as well as the use of false records to claim payments. The healthcare regulations have also made efforts to empower whistleblowers in cases of false information presentations. The reforms do not require the whistleblowers to be the actual source of information presented. The regulations have given them the authority to initiate false claims actions from the information available in the public domain through the administrative, criminal, as well as from the civil proceedings. The regulations have also brought about the regulations in the financial relationships between the physicians and the hospitals under the Anti-Kickback Statute. The hospitals are now required to make certain that the relationship between them and the physicians is not for the financial gains. The hospitals now suffer potential lawsuits in cases where they offer free services on medical practices, make unnecessary payments, and provision of discounts.
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