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programs, as well as, the HIPAA privacy and security rules. Most healthcare organizations and providers are also subject to the regulatory framework of the Food and Drug Administration, the DEA, and numerous other state and federal agencies. Each of these governmental agencies issues rules and regulations that interpret the laws those agencies are charged with implementing. Each state has its own overlapping set of laws and rules applicable to healthcare. Some mirror the federal laws while others differ significantly. Healthcare organizations and providers are required to comply with both sets of laws and regulations simultaneously. Large healthcare organizations that have operations in multiple states often have different requirements between their facilities based upon the state law applicable to a particular facility. Due to the volume and complexity of this regulatory framework, most healthcare organizations and providers must rely upon specialists in healthcare compliance to develop, implement and update their compliance programs. A large healthcare organization can have hundreds of people working under its chief compliance officer. Why Is Healthcare Compliance Important? Ultimately, the purpose and primary benefit of healthcare compliance is to improve patient care. Patient care is improved when healthcare decisions are based upon appropriate and current clinical standards. Patient care decisions based upon improper motives rarely results in the delivery of quality care. Healthcare compliance also aids healthcare organizations and providers in avoiding trouble with government authorities. An effective healthcare compliance program can identify problems and find solutions to those problems before a government agency finds the problem. An effective healthcare compliance program can also mitigate against the imposition of sanctions, or financial penalties that might otherwise be imposed on the healthcare organization or provider. A review of the recent OCR settlements for HIPAA breaches shows that the OCR imposes higher fines when the healthcare organization had not developed and implemented effective HIPAA compliance. A large number of healthcare organizations and providers have self-disclosed matters identified through their compliance programs to government agencies. The penalties imposed upon those self-disclosing organization and providers were far less than the penalties and other sanctions imposed on organizations and providers that were prosecuted for their misconduct. An effective compliance program can also help a healthcare organization or provider avoid liability for malpractice. A consistent theme in healthcare compliance is documentation that the organization or provider is following current clinical standards. A healthcare organization or provider that is following best clinical practices is less likely to be the subject of a malpractice claim. Challenges For Organizations and Providers It is nearly impossible to overstate the complexity of healthcare compliance. The avalanche of laws, rules, regulations and standards that apply to healthcare organizations and healthcare providers is daunting. Many people consider the Internal Revenue Service code to be an overwhelming mass of overly complex laws, rules and regulations. The laws and rules applicable to healthcare organizations and providers are far more numerous than the IRS code, and significantly more complicated. Healthcare organizations and providers are not only required to comply with the Medicare rules and regulations, but they are also required to comply with numerous other federal and state healthcare laws, rules and regulations. Healthcare organizations and providers must also comply with all the regulations that apply to non-healthcare businesses such as the regulations of the Occupational Safety and Health Administration (OSHA), and the Equal Employment Opportunity Commission (EEOC) to name two. Healthcare organizations and providers need an individual, or individuals, that can assist them in the development, implementation, and management of an effective healthcare compliance program. The chief compliance officer is the point person that makes sure the healthcare compliance program is kept current, including all the policies and procedures that are part of the compliance program. In a large healthcare organization that job cannot be accomplished by a single individual. Large organizations will require multiple individuals, and whole departments devoted to healthcare compliance. Healthcare compliance is cumbersome, perhaps overly cumbersome, but it is here to stay. Michael L. Smith is board certified in health law by The Florida Bar and practices at The Health Law Firm in Altamonte Springs, Fla. This article is for general information only and is not a substitute for formal legal advice. I. Purpose This plan applies to all lines of business including Fully Insured, Self-Funded, Government Programs such as Medicare, all Commercial lines of business, and all Qualified Health Plans (including at least one QHP in the silver level of coverage, at least one QHP in the gold coverage level, and a child-only plan at the same level of coverage, as described in section 1302(d)(1) of the Affordable Care Act, as well as any QHP offered through the Exchange to individuals who, as of the beginning of the plan year, have not attained the age of 21, at least one small group market QHP at the silver level of coverage and one at the gold level of coverage). Beginning January 1, 2019, FHCP is no longer the direct holder of a Medicare Advantage/Prescription Plan (MAPD) contract with CMS, but, is the first tier entity under another GuideWell company holding the contract. As such, all MAPD requirements apply to services provided by FHCP under that agreement. Specific plans/processes to comply with specific Marketplace requirements can be found in FHCP’s administrative policies and procedures. The purposes of this plan are to (i) stress FHCP’s commitment to corporate compliance, and (ii) serve as a reference for FHCP Compliance Committee members, administrators, managers, employees, and contractors (including providers) in carrying out their functions in accordance with our Code of Conduct. II. What is a Compliance Program? “A compliance program is a comprehensive strategy to ensure an organization consistently complies with applicable laws relating to its business activities.” Source: American Academy of Healthcare Lawyers “A compliance program is a process that assists an organization to improve its twin goals of servicing people who need quality medical care and operating a business efficiently under various laws and regulations.” Source: Model Compliance Plan for Hospitals, DHHS-OIG, June 1999 A compliance program has two main objectives: 1. Prevent and detect violations of law that may result in a liability, and 2. When violations occur, ensure that corrective action is taken to prevent recurrence. Compliance Plan 1 - 2 Revised December 12, 2018 III. Why Have a Compliance Program? An effective compliance program provides a mechanism that brings the public and private sectors together to reach mutual goals of reducing fraud and abuse, improving operational quality, improving the quality of health care and reducing the costs of health care. Attaining these goals provides positive results to business, Governments, individual citizens and beneficiaries alike. In addition to fulfilling its legal duty to ensure that it is not submitting false or inaccurate information to the Government, an organization may gain numerous additional benefits by implementing an