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The concept of healthcare compliance programs began in 1997 with a publication by the Office of Inspector General (OIG) within the US Department of Health and Human Services (HHS). That first program was designed for individuals and small group physician practices. Since that time, there have been an entire series of HHS OIG compliance guidelines addressing other segments of the health care industry that includes: nursing facilities, HHS research grants and awards, hospitals, pharmaceutical firms, ambulance providers, hospices, home health agencies, clinical laboratories, third-party medical billing firms, and providers of medical supplies and equipment.
The Affordable Care Act mandated additional corporate healthcare compliance programs in 2010 for Medicaid and Medicare providers. The essence of this compliance program requires any Medicaid provider receiving $5+ million annually in payments have mandatory written policies that affect all employees and certain types of vendors regarding state and federal violation of anti-fraud laws, whistle blowers legal protections, and all policies addressing fraud detection and prevention. A well-defined compliance program is a prerequisite for Medicare and Medicaid participation.
Healthcare compliance programs are the guidelines for efficient internal controls that are governed by private, state, and federal health plans. Most compliance programs are still voluntary, but compliance programs are mandatory for participation in Medicaid and Medicare plans. However, the development of either a voluntary or a mandatory program will enhance the detection, prevention, and resolution of circumstances and situations that do not conform to legal health care requirements as well as ethical and business practices. An effective program needs to contain benchmarks for implementation and achievements that meet federal and state laws as well as the expectations of industry regulators.
The HHS OIG has developed a list of seven core elements that every healthcare compliance program needs to address. They are:
1. Implementation of procedures, policies, and conduct standards
2. Designation of a compliance officer and committee to monitor the efforts and the enforcement of practice standards
3. Institute training and education sessions on compliance procedures, policies, and conduct standards
4. Development of effective communication lines with staff personnel that includes anonymous reporting avenues
5. Use of periodic self-audits to conduct internal monitoring and auditing
6. Enforcement of employee standards using well publicized disciplinary guidelines
7. Prompt response when discovering offenses and the development of corrective action plans
The HHS OIG has published a directory of recommended compliance program guidance documents that can be viewed at http://oig.hhs.org/compliance/compliance-guidance/index.asp.
The healthcare community is experiencing an environment of ever increasing regulations and enforcement. A strong, enforceable compliance program is a positive, protective tool that ensures adherence with all laws and regulations that govern a specific practice. A well-structured program enables a provider to isolate and correct any deficiencies before they can negatively impact a practice. Consultation with a professional, experienced healthcare lawyer will enlighten healthcare providers on the development and implementation of compliance programs that addresses their specific needs and provides them with real protection aimed at minimizing, or eliminating, any potential risks within their particular practices.
A program that is finely tuned and followed is no guarantee that a practice will never be investigated. However, in the event that there is an investigation, having a solid compliance program, with all of the supporting documentation, demonstrates a provider’s commitment to patient safety, violation avoidance, and full adherence to all governing healthcare laws, policies, and regulations. An active compliance program improves the provider’s chances of having a violation viewed as an accidental, one-time, occurrence rather than evidence of a pattern of fraud.
Government and private sector payors are consistently concerned with the rising cost of health care and have increased their attention on finding and eliminating fraud, waste and abuse. The result of this intensity is an enormous rise in the number of audits related to Medicaid, Medicare, and third party payors. Any confirmed violations involving fraud will result in a practice or service be excluded from Medicaid and Medicare participation. A finding of fraud can also result in high fines, potential loss of professional licenses, and possible prison time. Any provider facing compliance audit investigations will need specialized healthcare audit lawyers. Our experienced attorneys help our clients with their defense against alleged compliance investigation audits.
Our health care lawyers work with providers in structuring business compliance programs that meet healthcare practice goals while staying current with all up-to-date federal and state laws, rules, and regulations. We not only work for our clients, we stand with our clients when representation is required.