Healthcare compliance issues can affect every type of medical facility, regardless of the size. Large and small healthcare businesses alike are required to follow a certain set of rules and governances to comply with government oversight and regulations.
To stay out of harm’s way, all organizations should be familiar and compliant with changing healthcare trends, guidelines, compliance laws, and government regulations. To minimize their liability risk and government scrutiny you may consider a medical compliance plan or consulting a compliance officer. The role of a compliance officer in healthcare is to ensure your medical practice adheres to all policies and statutes and will implement change when a practice is non-compliant.
What is Regulatory Compliance in Healthcare?
Healthcare Compliance is a multi-layered system of checks and balances. These systems are in place to promote quality of care and protect Medicare, Medicaid and program beneficiaries from fraud, waste, and abuse.
Healthcare Compliance is the ongoing process of meeting or exceeding the legal, ethical, and professional standards applicable to a particular healthcare organization or provider.
The compliance function promotes the prevention, detection, and resolution of actions that do not conform to legal, policy, or business standards. This responsibility includes:
Who Governs Healthcare?
A collection of agencies regulates and governs healthcare. These agencies are responsible for creating the ever-changing set of rules, investigating violations, and enforcing penalties for those who are non-compliant. A healthcare compliance officer will be certified in meeting these metrics; their responsibility to their organization or contractor will ensure standardized guidelines are met.
The Department of Health and Human Services and the Office for Civil Rights (OCR) oversees HIPAA Privacy and Security Rules. They investigate healthcare providers and their business associates to ensure patient information remains protected. They publish a useful set of HIPAA Privacy Rules guidance materials, which will help an organization maintain compliance. The Health Insurance Portability and Accountability Act was enacted in the early 2000s to provide a set of standards for securely accessing medical information electronically. Congress did not want to erode the privacy of health information as it becomes electronic; therefore this mandate was implemented to federally protect data.
The Centers for Medicare and Medicaid Services are responsible for implementing the government’s Electronic Health Record (EHR) Incentive Program. Operating in conjunction with the HITECH Act, CMS required healthcare professionals to demonstrate meaningful use of EHR technology. Practices who did not establish meaningful use practices were penalized in the form of reduced Medicare and Medicaid payments. This program was rolled out in phases; current updates outlining the third and final stage can be found here. CMS, (under the Department of Health and Human Services umbrella) is also responsible for an entire body of healthcare compliance rules, governing nearly all aspects of medicine.
The Office of the National Coordinator for Health Information Technology (ONC), is responsible for the implementation and use of electronic health records and information exchange. They facilitate the adaption of electronic record-keeping and encourage and support medical centers in providing improved health care and lower costs through a fully paperless system. Their goal is to digitize all health records and allow every American citizen full access to their entire medical history. The ONC has prepared a manual titled the Nationwide Interoperability Roadmap to facilitate this access. This guide provides instructions and schedules to a holistically integrated digital medical system. A concise infographic from the ONC is available here ->
Who Performs Healthcare Compliance?
While every employee should be diligent in adhering to compliance standards, the majority of legwork begins with the appointed Compliance Officer. Depending on the size of the medical practice the appointed officer, or the entire team, will develop, maintain and implement healthcare compliance-related duties.
The Compliance Team members and officers will be responsible for a variety of standards and policies based of their certifications and areas of expertise. The four leading compliance certifications are below.
If My Data is Secure, It Must Be Compliant, Right?
A common misconception about security and compliance is that they are interchangeable: if you are comprehensive in one area, you are in the other as well. Over the years, we have heard examples of C-level officers losing their jobs because their data was hacked, even if they were a fully compliant organization. Many organizations deemed “compliant” have still fallen victim to a severe public breach. Without a smart, thorough, and active security program, coupled with a solid compliance plan, you’re at significant risk of being breached. This results in expensive fines, increased audits and brand damage.
An IT security officer will be responsible for providing strategic, tactical planning for a secure framework. An employed framework is applied to both the data (software) and the servers, and computers (hardware) the data is stored on. The goal of the IT security officer is to mitigate unauthorized access, use or misuse. A “secure” network will preserve the value, integrity, availability, and ability of systems to perform their critical functions.
A compliant system will keep data private, and a secure system will keep data, well, SECURE! While the two pillars of business go hand in hand, they are meant to stand on their own. That is because compliance requirements are established slowly and met over time. They evolve gradually and are typically reviewed once a year. Whereas security threats are an ever-changing target and can alter from day to day. Compliance and Security Measures should both be met and assessed independently. Your IT provider should have an open dialogue with your organization about what they can deliver to ensure all metrics are exceeded.
If you’re a compliance officer or looking for ways to improve the compliancy within your organization, refer to the graphic below for the basic pillars. Regardless of the number of patients you serve, the goal of compliancy is always to serve the patient. Patient outcome is improved when all aspects of the organization are working together to make decisions based off appropriate and current medical standards.
Healthcare compliancy is extensive. Many people think that the IRS tax codes are complex and vast, however, the rules governing healthcare are far more numerous. Multiple federal agencies are responsible for governing the healthcare sector as well as each state providing its own set of unique rules.
Do not assume you should handle this task independently. It is always wise to have a second set of eyes, another compliance officer, or an attorney consult with your organization to ensure all regulations are met.
Building an Effective Healthcare Compliance Program:
CMS has approved several organizations to help your practice navigate the agency’s requirements. Depending on the size and nature of your healthcare business you may consider contacting one or all of these. Their sole mission is to service medical offices and hospitals in meeting all oversight metrics.
The Compliance Team
Assign someone with experience to assist your organization
Empower the compliance team to obtain necessary knowledge from employees, board members, vendors, and other business entities
Utilize a third-party to build a scalable and mature compliance plan
Governmental oversight and regulation of healthcare will never be eliminated entirely. In fact, governmental regulation and oversight will increase, at least in the near future, as the government agencies implement more quality-based requirements.