Regulatory Regulation Compliance Requirements

Regulations are entrenched in licensures and inspections of providers and organizations in order to provide the practice of safe medical care to its recipients and to hold providers responsible for their actions and performances. Regulatory standards improve the safety of consumers’ health and quality of care through regular yearly inspections performed by regulatory bodies to monitor and evaluate facilities and providers for occurrences of violations. Regulation compliance requirements in these areas are necessary to ensure that consumers are receiving safe and proper care to meet their healthcare needs in order to serve three purposes.

According to Kohn, the first purpose is “they provide the public with a minimum level of protection by

assuring that the most serious errors are reported and investigated and appropriate follow-up action is taken”. Second, “they provide an incentive to health care organizations to improve patient safety in order to avoid the potential penalties and public exposure”. Finally, “they require all health care organizations to make some level of investment in patient safety to help improve the healthcare of its consumers”. (Kohn et al., 2000) Health care regulations are developed and enforced by all levels of government, federal, state and local industries in providing quality care to consumers.
Moreover, pharmaceutical companies must develop “patents to protect their products through the federal Patent and Trademark Office (PTO)”. (Fields, 2008) They must also obtain “permission to conduct clinical testing from the federal Food and Drug Administration (FDA)”. (Fields, 2008) It is also noted that “any approval for marketing is received in the form of a New Drug Approval (NDA), and the manufacturer must adhere to marketing restrictions contained in the NDA”. (Fields, 2008) However, it is important to also be aware that the drug cannot be dispensed without following regulation standards and requirements.
Limitations of Regulatory Requirements in Health Care
Healthcare licensures and insurance are denied when organizational regulations are violated. Healthcare organizations cannot operate or practice care to patients without meeting regulatory compliance requirements. Organizations can receive violations and incur penalties for non-compliance of state and federal law regulations resulting in enormous costs to the facility. These actions may also result in loss of quality care to consumers, accreditations, licensure, and possibly closure of the facility. However, regulatory bodies must revisit these facilities to reevaluate if compliances are maintained for the safety of the patients, and the possibility that they will reinstate the facilities license and insurance.
Provider’s Licensure Limitations. Providers must obtain a license to practice medicine through regulatory standards in order to receive reimbursement claims for services rendered. If providers fail to comply with the standards in the regulatory process such as HIPPA, HITECH Act, U.S. Department of Health and Human Services, and the Center for Medicare and Medicaid, penalties are ensued. Providers that attempt to practice without following these guidelines may be subjected to reimbursements loss. Furthermore, providers and healthcare organizations must comply with financial standards associated with Occupational Safety and Health Administration (OSHA).
Insurance Limitations. The Affordable Care Act regulations prevents insurance companies from discriminating against consumers with pre-existing conditions and incentives provided through CMS. Consumers are allowed options for health plans and coverage for prescription drugs, and wellness programs. The guidelines for the ACA specify that penalties against insurance companies will ensue if they deny an individual for health care due to discriminations and preexisting conditions.
Conclusion
Healthcare regulations are a necessary commodity in our nation’s organizations and facilities for the safety and well-being of consumers. There are limitations, such as licensure and insurance, however, the guidelines are created through state, local, and governmental agencies that help ensures that the safety of drugs, medical supplies, licensure and practices meet specified regulatory standards requirements, and are practiced within the scope of medicine for the protection and welfare of its citizens.