The healthcare industry is constantly evolving as legislators, payers, patients and other stakeholders adapt to new realities. In health systems, the governance, risk and compliance (GRC) function is not just the task of following the law. Providers and support staff also need to understand the changing legal landscape. Regulatory frameworks are essential to ensure compliance with basic standards, but in some cases the impact of regulatory, legal and ethical issues can be significant. In particular, the increased complexity of the COVID-19 pandemic has had a major impact on health care laws this year. Check out our overview of seven legal issues that providers and administrators should be aware of in 2021. The Emergency Medical Treatment and Work Act (EMTALA), enacted in 1986, is a federal law that requires hospitals to provide stabilization and treatment to anyone who presents to the emergency room, regardless of their insurance status or ability to pay. President Johnson`s 1965 Act also included a provision to provide insurance to low-income individuals. [3] Today, Medicaid covers more than 70 million U.S. citizens. In 2014, the program reimbursed hospitals for nearly 50% of all medical expenses. The Department of Justice (DOJ) recovered more than $2.2 billion in settlements and judgments related to the False Claims Act (FCA) in 2020, including $1.8 billion related to the health care sector. The CFA is the foundation of the fight against health fraud and the civil law tool for the DOJ to resolve false claims for federal funds.
The 2020 measures involved drug and medical device manufacturers, managed care providers, hospitals, pharmacies, palliative care organizations, laboratories and physicians. The following trends are trends in FCA comparisons so far this year and are expected to continue: This country profile on rights of lawful access to healthcare was developed to analyse the capacity of German laws to provide universal services. Responsible Care Organizations (ACOs) also pose a legal challenge, as competing hospital systems must come together and share pricing information. Technically, this could be considered illegal under the Sherman Act. While the goal of responsible care organizations is to help hospitals reduce prices, it is possible that ACOs can be used as a means of raising prices. The cost of non-compliance can be high, with businesses facing fines of up to $1.5 million per calendar year for each violation. You may also suffer losses related to notifying patients affected by a breach through investigations, audits, and other legal issues. symplr Compliance provides legal and regulatory content in its risk assessment management module of our powerful and flexible platform. We provide the software, tools and unique expert content you need to assess your regulatory compliance position and discover changes in health laws that impact your business. Learn more about symplr compliance and our comprehensive portfolio of GRC solutions. Collection audit contractors, who are responsible for auditing suppliers while researching overpayments, also have a huge impact on the healthcare sector.
While hospitals and doctors` offices can appeal contractors` decisions for collections audits, the process can be lengthy and costly. In the event of a loss of appeal, the hospital or practice must pay annual interest on the amount owing. Co-management agreements refer to agreements under which a hospital pays physicians for performing certain tasks while meeting performance targets. Such agreements can lead to legal issues related to anti-bribery laws, antitrust laws, physician self-referral bans, civil fines, and health insurance regulations and laws. The Act applies not only to hospitals and doctors` offices, but also to chiropractors, dentists, nursing homes, pharmacies and psychologists. In addition, the law regulates the activities of business partners such as third-party administrators, pharmacy benefit managers for health plans, billing and transcription companies, as well as professionals who perform legal, accounting or administrative work. Laboratories that perform DNA or paternity testing follow similar documentation procedures and legal requirements. In-home curiosity DNA tests, such as those available from 23andMe or similar companies, may be prohibited in some states because a chain of custody cannot be established. Hospitals are also facing increasing age-discrimination lawsuits related to layoffs.
In addition, hospitals need to process more accommodation requests for employees with disabilities. To avoid legal action, hospitals should ensure accurate job descriptions and implement formal written guidelines regarding employee layoffs. Privacy and confidentiality In health care, privacy is the right of individuals to restrict access to their health information. Confidentiality is the expectation that information shared with a health care provider during treatment will only be used for its intended purpose and will not be otherwise disclosed. Privacy is based on trust. There are many sources of legal and ethical requirements that health care professionals maintain the confidentiality of patient information and protect their privacy. Ethical and professional standards, such as those published by the American Medical Association and other organizations, address professional conduct and the need to maintain the confidentiality of patient information. For all aspects of health, there are binding rules that govern the rights and obligations of governments, health workers, businesses, civil society and the population of a country.
Together, these rules form the legal framework or architecture of health. They take many forms, including: statutory statutes, regulatory and administrative laws, contracts, case law and common law. The people involved in creating these rules and their form vary from country to country. Healthcare organizations such as hospitals, nursing homes, home health agencies, etc., must be allowed to operate. If they want to file for Medicare or Medicaid, they also need to be certified, and if they want to demonstrate excellence, they go through an accreditation process. Approval is therefore the process that grants a facility legal permission to operate. Certification gives a health organization the authority to participate in federal programs. Accreditation is an external verification process to which an organization is subject. Under the supervision of Congress, U.S.
health departments develop laws to protect the public welfare. The Department of Health and Human Services (HHS) oversees the general health issues and concerns of all U.S. citizens and leads initiatives to improve public health and pursue medical research. In 2016, HHS`s mission was to improve patient outcomes and reduce medical costs. Over time, HHS has worked to achieve these goals by supporting various new laws. As a result, the following eight laws have had a significant impact on health in America. While there are specific retention requirements and general guidelines, it is increasingly popular for healthcare organizations to retain all legal health records indefinitely, especially if the information is stored in an electronic format. If an organization decides to destroy legal medical records, such destruction must be done in accordance with all applicable laws and regulations.
According to the anti-bribery law, a hospital`s financial relationship with doctors is regulated. To avoid potential lawsuits, hospitals need to ensure that all relationships with doctors are not just a way to get payments for doctors for referrals. Health organizations can get into trouble with this law if they offer free services at a doctor`s office or if they offer discounts or pay for unnecessary services. These are just a few areas of regulation that health officials face.