Table of Content +
- 1 Defining Healthcare Compliance
- 2 Healthcare governance, risk management, and compliance (GRC)
- 3 Regulating Healthcare Compliance
- 4 Some examples of regulations in the healthcare sector
- 5 Importance of healthcare compliance
- 6 Ensuring Healthcare compliance
- 7 What if healthcare organizations don’t follow the rules?
- 8 What does a compliance plan entail?
- 9 Challenges for Healthcare Organizations and Providers
Defining Healthcare Compliance
The healthcare industry puts a high focus on patient data protection. If patient data is exposed, organizations may face severe consequences. In fact, they might be fined for breaking the Health Insurance Portability and Accountability Act’s regulations (HIPAA). According to the American Medical Association, penalties can range from $100 to $1.5 million. In both patient care and service providers’ daily clinical operations, healthcare compliance becomes important. It is important for organizations to hire personnel that are well-versed in healthcare compliance. To get a better understanding of health care compliance, organizations should explore the following terms and background:
The ongoing process of meeting or exceeding the legal, ethical, and professional standards relevant to a particular healthcare organization or practitioner is known as healthcare compliance. The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has contributed to the definition of healthcare compliance with its compliance guidance documents. Efforts to build a compliance culture within organizations are supported by this guidance. A compliance culture promotes the prevention, detection, and resolution of violations of government laws, public and private payer healthcare program requirements, and ethical and business policies. A patient care, billing, reimbursement, managed care contracts, research standards, OSHA, The Joint Commission standards, and HIPAA privacy and security, to name a few, are all covered by compliance.
Healthcare governance, risk management, and compliance (GRC)
Healthcare compliance refers to an organization’s compliance with all applicable regulations and requirements across a broad variety of criteria, which can vary greatly depending on the type of organization and the services it provides. These rules are complex and always changing, necessitating operational and workflow modifications, continuing education, internal audits, health IT compliance updates, and more. One thing to keep in mind is that healthcare compliance applies to all healthcare organizations large and small. It’s part of a broader strategy known as healthcare governance, risk management, and compliance, or GRC, which is critical to ensuring a safe, high-performing, and reliable environment. GRC encompasses your entire organization and aids in:
- Ensure safety and compliance
- Assess quality and performance
- Credential and enroll providers
- Optimize your workforce
- Monitor facility access and security
Regulating Healthcare Compliance
Health compliance is regulated by a number of federal and state agencies. The Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA), for example, both control drug development and distribution. They ensure that drugs, biological products, and medical equipment are safe and effective. The FDA also provides reliable, science-based information to the general public. The Department of Health and Human Services (HHS) and the Office of Inspector General (OIG) audit healthcare organizations to assist prevent waste, fraud, and misuse of healthcare funds. The Office of the Inspector General (OIG) releases an annual Work Plan each year to announce the specific issues it plans to focus on that year, giving organizations advance notice of the types of audits they may face. Both the OIG and the HHS offer a variety of instructional materials to help healthcare firms stay ahead of the game when it comes to following healthcare rules and regulations.
Compliance is a priority for a number of other important organizations. The Joint Commission (TJC), for example, accredits and certifies institutions that fulfill particular compliance criteria in healthcare for patient care quality and safety, primarily hospitals and healthcare systems. The National Association for Healthcare Quality (NAHQ), like TJC, serves health plans and credentialing verification agencies. Various quality initiatives have been launched by the Centers for Medicare & Medicaid Services (CMS) and other payers to promote high-quality healthcare through accountability and public transparency. Quality improvement, pay-for-performance approaches, and public reporting all benefit from these metrics. The Agency for Healthcare Research and Quality (AHRQ) also offers a variety of services to assist healthcare institutions in providing safe, high-quality care.
Some examples of regulations in the healthcare sector
Healthcare organizations must follow lots of rules, far too many to detail here. However, the following are some of the most important statutes:
- Medicare, Medicaid, the Children’s Health Insurance Program, and other programs are all governed under the Social Security Act.
- The Health Insurance Portability and Accountability Act (HIPAA) of 1996 protects patient privacy and mandates that medical records be kept private.
- HIPAA was expanded in 2009 by the Health Information Technology for Economic and Clinical Health (HITECH) Act, which established some health IT compliance standards for the deployment of electronic health records.
- It is against the law for providers to submit a false claim to a government payer under the False Claims Act. It has a qui tam clause that allows non-government employees (sometimes known as relators or whistleblowers) to sue the perpetrator on behalf of the US government.
- The Anti-Kickback Statute forbids organizations and providers from getting a financial benefit in exchange for patient referrals if the federal government would be charged for all or part of the expense. What is the goal? To prevent financial gain from influencing medical care decisions.
- Similarly, the Physician Self-Referral Law (Stark Law) forbids doctors from recommending Medicare or Medicaid patients to a service or company with which the doctor or a member of his or her immediate family has a financial relationship.
- More recently, the Patient Protection and Affordable Care Act (PPACA) imposed new insurance, Medicaid, and other regulations.
- The Centers for Medicare & Medicaid Services (CMS) also passed the Interoperability and Patient Access Final Rule, which gives patients more control and access to their electronic health records.
- The CMS’ Hospital Price Transparency Final Rule, which requires hospitals to publish prices negotiated with health insurance, is another new regulation.
Importance of healthcare compliance
Because the stakes are so high, healthcare compliance is important. The consequences can be life or death in some scenarios. Patient outcomes, care coordination, and patient safety can all be harmed by seemingly minor errors. Healthcare compliance at the organizational level guarantees that everyone follows the rules and understands the expectations, all with the objective of providing high-quality, safe patient care.
Ensuring Healthcare compliance
The first step is to establish a health-conscious society. This entails taking steps to ensure that everyone in the organization is aware of how their activities affect overall healthcare compliance and that they endeavor to follow all laws and regulations on a daily basis. When mistakes happen, businesses with a culture of healthcare compliance try and figure out why they happened and take steps to prevent them from happening again. It takes time to establish a culture of healthcare compliance. To get it right, you’ll need time, training, and a series of trial and error stages. And getting it right necessitates a continuous effort aided by a compliance officer and a compliance department specialized in healthcare compliance. It also necessitates the support of the top management. From the top-down, leaders set the tone and encourage ethical behavior.
What if healthcare organizations don’t follow the rules?
Organizations that break the law may face legal action, fines, or recoupments. They may potentially lose their capacity to work with payers on contracts. Individual providers’ medical licenses could also be revoked. Noncompliance also has a reputational impact. Patients may be less likely to seek care from an organization if they learn that it is unsafe or does not follow the rules. This has a negative financial impact on the company, and repairing it can take years.
What does a compliance plan entail?
Organizations must have a healthcare compliance plan in place, which includes written rules, processes, and standards of conduct. The Office of the Inspector General recommends that hospitals concentrate on high-risk areas such as billing for services not rendered, upcoding, unbundling, and duplicate billing, claim development and submission, medical necessity, anti-kickback, and self-referral concerns, bad debts, credit balances, record retention, and more.
Internal audits and the results of Comprehensive Error Rate Testing (CERT) should both be considered in a healthcare compliance plan. Based on a statistically reliable random sample of Medicare fee-for-service claims, the CERT program estimates a nationwide erroneous payment rate as well as contractor- and service-specific wrong payment rates. Organizations can utilize this data to identify regions that could be high-risk, and then undertake a risk analysis to assure healthcare compliance.
In addition, the Department of Justice offers a comprehensive guide on how to build a successful healthcare compliance plan. Although the purpose of this document is to help prosecutors determine whether and to what extent an organization’s healthcare compliance program was effective at the time of the offense, it can also be used by organizations to proactively enhance their compliance programs.
Organizations must also ensure that auditing and monitoring are carried out on a regular basis. Because it can proactively identify and convey operational and financial risk enterprise-wide in real time, healthcare compliance software can be very helpful. The essential, regardless of whether or not a company employs software, is to conduct regular audits. If a company doesn’t look into actual workflows to check if employees are following stated policies and procedures, it won’t know if it’s compliant. Organizations may choose to conduct annual audits on specific themes or audit more regularly (e.g., quarterly or monthly) to keep a closer eye on performance. When an auditor discovers a non-compliant person or department, they should provide education on how to correct the problem. It’s just as crucial to enforce compliance standards in healthcare through well-publicized disciplinary guidelines. Someone who consistently breaks the rules, for example, may suffer a temporary suspension or perhaps firing. This is true for everyone in the company, from the top down. For chronic noncompliant behavior, no one should be spared from disciplinary action.
Challenges for Healthcare Organizations and Providers
The intricacy of healthcare compliance is practically impossible to overstate. It’s difficult to keep up with the avalanche of laws, rules, regulations, and standards that apply to healthcare organizations and agencies. Many people regard the Internal Revenue Service Code as a maze of unnecessarily complicated laws, rules, and regulations. The laws and regulations that apply to healthcare organizations and providers are substantially more complex and sophisticated than the IRS code. Not only are healthcare organizations and providers obligated to follow Medicare rules and regulations, but they must also follow plenty of other federal and state healthcare laws, rules, and regulations. Healthcare organizations and providers must also follow all non-healthcare rules, such as those imposed by the Occupational Safety and Health Administration (OSHA) and the Equal Employment Opportunity Commission (EEOC), to mention a few. Healthcare organizations require the assistance of a person or people who can help them establish, implement, and manage effective healthcare compliance. The chief compliance officer is the person in charge of keeping the healthcare compliance program up to date, which includes all of the policies and procedures that make up the program. That work cannot be done by a single person in a huge healthcare organization. Healthcare compliance will necessitate many personnel and entire departments in large firms. Healthcare compliance is difficult, perhaps excessively, but it is unavoidable.