Implementing a compliance program in your healthcare practice can go a long way towards avoiding accusations of fraud or abuse and successfully navigating any claims that are made. A well-designed program can eliminate or substantially reduce billing errors and other unintentional missteps that can trigger fraud investigations. Evidence of an implemented compliance program can also be helpful in refuting accusations of willful misconduct, serving as evidence of good faith and intent to comply with the law.

Practicing healthcare in today’s regulatory environment is complicated business. A number of federal statutes pertaining to health care contain compliance provisions. Healthcare fraud and abuse prevention has been the major effort of the federal agencies such as the Office if Inspector General (OIG), the Department of Health and Human Services (HHS), and the Department of Justice (DOJ). There has been a dramatic increase in criminal, civil, and administrative enforcement actions during the past decade. Creating a compliance program, which today is standard practice, may be mandatory or voluntary. While, in most cases, compliance programs are voluntary, recent changes in the law have made them mandatory in certain circumstances.

Why Have Compliance Program

There are many reasons why a compliance program should be created. The Federal Sentencing Guidelines, for instance, contain provisions, which may significantly mitigate criminal penalties for healthcare entities convicted of health care fraud if the entities implemented compliance programs. In the same way, the OIG has announced that health care providers operating without compliance programs may face more serious penalties in OIG enforcement actions. Also, under the Affordable Care Act, providers who participate in Medicaid, Medicare, and other federally funder programs must have compliance programs.

OIG Compliance Guidance applies to numerous providers:

• Hospitals
• Home Health Agencies
• Third Party Billing Companies
• Durable Medical Equipment
• Hospice
• Medicare Choice Organizations
• Nursing Homes
• Individual and Small Group Practices
• Ambulances
• Pharmaceutical Manufacturers, and
• Public Health Services Research Awards

New York Healthcare Compliance Obligations

Federal law requires states to make written policies mandatory for providers who receive $5 million or more annually in Medicaid payments. These policies are to be directed at employees and some types of vendors. They must set forth the consequences of violating the False Claims Act and other federal and state anti-fraud laws, describe legal protections for whistleblowers, and contain the provider’s policies aimed at fraud detection and prevention. In New York, a practice is obligated to file a certification of compliance each year with the Office of the Medicaid Inspector General.

Another New York State law that imposes a mandatory compliance program is applicable to providers governed by the Mental Hygiene Law or the Public Health Law, and to providers that have involved Medicaid as a substantial part of their business operations. In this context, “substantial” means that the provider claims or receives at least $500,000 from Medicaid within 12 months. These providers must implement a compliance program and submit an annual certificate of compliance to the OMIG.

Compliance Programs for Medicaid and Medicare Providers

Compliance programs are now required as part of the preconditions for participating in Medicare, Medicaid, and SCHIP. While, in the past, compliance programs were supposed to focus mainly on avoiding fraud, waste, and abuse, today’s compliance guidelines also cover issues such as patient care, medical records, and virtually all aspects of a healthcare practice.

Compliance programs are increasingly important not just for physicians, but for other healthcare providers as well, including laboratories, pharmacies, nursing facilities, durable medical equipment manufacturers and suppliers, home health agencies, and hospitals. An effective compliance program should be tailored towards the specific issues faced by each type of provider.

What Does A Compliance Program Contain

To meet requirements, healthcare compliance programs must typically contain the following provisions: designation of a compliance officer to oversee the program, training and education of providers and employees, setting forth compliance and practice standards, internal auditing and monitoring to catch lapses in compliance as soon as possible, action to be taken in the event that an offense occurs, dissemination of practice guidelines and maintaining disciplinary standards, and open lines of communication allowing the existence of an offense to be promptly brought to the attention of appropriate personnel.

Effective compliance programs are designed specifically to take into account the particularities of an individual practice. Everyone in the practice should be aware of applicable laws and standards. The program should aim to prevent fraud as far as possible, while also being structured to detect and correct any improprieties as soon as they occur.

In a healthcare practice, a compliance program should address several key activities of the practice that are also areas of concern in terms of potential for violation of fraud or anti-kickback statutes. These areas include billing, coding, medical records, copayments, referrals, and dealings with other providers.

While a compliance program will not guarantee that you will not be investigated or even that an investigation will conclude in your favor, it can go a long way to reduce the potential fallout of an investigation. For instance, if the government considers your program reliable, it may rely on information from your auditing and monitoring program, which will reduce the scope of the investigation and its disruptive effect on your practice. Further, the existence of a well thought-out program points to an intention of upholding the law and avoiding violations and increases the chances that the government will see a violation as an isolates, accidental instance and not as part of a pattern of fraud.

In many cases, the ultimate penalties for a violation depend on the degree of willfulness and the perceived chances of other violations occurring. A practice with an established compliance program is in a strong position to demonstrate an intent to comply with the law, resulting in far less severe sanctions. In a climate where findings of fraud can lead to tremendous fines, exclusion from Medicaid and Medicare, loss of professional license, and even time in prison, this is an important benefit.

Given today’s ever-increasing regulation and enforcement in all areas of healthcare, setting up a compliance program is an essential tool for protection. To make sure that your compliance program is effective, complies with the law, and addresses the specific circumstances of your practice, the best option is to consult an experienced healthcare attorney. Attorneys at our firm have provided guidance to many practices in setting up and implementing compliance programs that provide real protection. Contact us to discuss your compliance needs with us.