Healthcare compliance affects every type of healthcare provider and healthcare organization from the solo practitioner to the largest global healthcare conglomerate. For some, healthcare compliance is viewed as an unnecessary governmental intrusion and the imposition of unneeded oversight on overworked, underpaid, and underappreciated people that are devoting their lives to helping others. For others, healthcare compliance is seen as a means to improve the quality and availability of healthcare while controlling the costs of healthcare.

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 and other third-party payers implement more quality-based requirements.

The purpose of this examination of healthcare compliance is to provide an overview of the basics of healthcare compliance for organizations and providers. Essentially, this examination will attempt to explore the who, what, when, where, and why of healthcare compliance.

What Is Healthcare Compliance?

Healthcare compliance is the ongoing process of meeting or exceeding the legal, ethical, and professional standards applicable to a particular healthcare organization or provider. Healthcare compliance requires healthcare organizations and providers to develop effective processes, policies, and procedures to define appropriate conduct, train the organization's staff and then monitor the adherence to the processes, policies, and procedures. 

Healthcare in India features a universal healthcare care system run by the constituent states and territories. Law is an obligation on the part of society imposed by the competent authority, and noncompliance may lead to punishment in the form of monetary fine or imprisonment or both. The earliest known code of laws called the code of Hammurabi governed the various aspects of health practices including the fees payable to a physician for satisfactory services. The modern version of Hippocratic Oath(called the declaration of Geneva), devised by the WHO after the Second World War and is accepted by the international medical fraternity. The first legal recognition and registration for the Indian systems of medicine came when the Bombay Medical Practitioner’ Act was passed in 1938. Laws governing the commissioning of the hospital are the laws to ensure that the hospital facilities are created after due process of registration, the facilities created are safe for the public using them, have at least the minimum essential infrastructure for the type and volume of workload anticipated and are subject to periodic inspections to ensure compliance.

When Is Healthcare Compliance Required?

Every healthcare organization and provider needs a compliance program immediately. In fact, every healthcare organization and provider should have already established a healthcare compliance program.

A large healthcare organization must have a comprehensive compliance program involving numerous individuals from multiple disciplines. Some large hospital systems have compliance departments that include hundreds of individuals. A solo practice physician may not need an extensive compliance department, but that physician will need a compliance program just the same.

Healthcare compliance is also an ongoing process. A healthcare organization must constantly review and examine its processes and performance for adherence to minimum requirements as established by laws, regulations and professional standards. A healthcare organization must routinely audit its performance to ensure that it is meeting its requirements.

Central, state and local healthcare laws and regulations change constantly and the interpretation of those laws and regulations changes just as frequently. Effective healthcare compliance must be an ongoing process of continually reviewing and updating the processes, policies and procedures of the organization. The organization also must continually update the training provided to its employees based upon changes in the regulations.

Who Is Responsible For Healthcare Compliance?

The governing body of a healthcare organization is responsible for the conduct of the organization. Consequently, the governing body and the executive officers of the healthcare organization will bear the ultimate responsibility for a healthcare organization's compliance, or lack of compliance. The organization's governing body is responsible for directing the organization's administrators to develop and implement the organization's compliance program, as well as, authorizing funds to accomplish the task.

The governing body must rely upon the individuals in the healthcare organization to accomplish the organization's goals including its compliance goals. The governing body will be required to rely upon the compliance officer and the compliance committee to develop and implement the compliance program.

While the governing body, the compliance officer, and the compliance committees have primary responsibility for the organization's compliance program, every employee of the organization is responsible in their own way for healthcare compliance, and the success of the compliance program. The individual members of the organization can and should report any healthcare compliance concerns they have up the chain of command. Those individual members of the organization should not only communicate concerns within their individual areas of responsibility, but they should also report anything that appears out of the ordinary, unusual or questionable.

Every individual in the healthcare organization is responsible for the success of the compliance program because failures in the compliance program can impact every member of the organization. The imposition of sanctions in the millions of dollars is common, and even large organizations are affected by those sanctions.

Why Is Healthcare Compliance Important?

Ultimately, the purpose and primary benefit of healthcare compliance are to improve patient care. Patient care is improved when healthcare decisions are based on appropriate and current clinical standards. Patient care decisions based on 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. 

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.

Compliance and License Requirements for Healthcare Companies in India

The Ministry of Health and Family Welfare acts as a watchdog for regulating the healthcare industry in India. The Directorate General of Health Services (DGHS)renders technical advice on all Medical and Public Health matters and is involved in the implementation of various health services. The Pharmaceutical Industry is one of the areas which come under the ambit of healthcare compliances and is extensively regulated by the following:

1. Central Drugs Standard Control Organization(CDSCO)
2. National Pharmaceutical Pricing Authority(NPPA)
3. Indian Council for medical research(ICMR)
4. Drugs Controller General of India(DCGI)

1. Laws Governing the Commissioning of Hospitals, these are the laws to ensure that the hospital facilities are created after due process of registration, the facilities created are safe for the public using them, have at least the minimum essential infrastructure for the type and volume of workload anticipated, and are subject to periodic inspections to ensure compliance.
   
2. Laws governing the qualification /practice and conduct of professionals
3. Laws Governing to Sale, Storage of Drugs and Safe-Medication, these are laws to control the usage of drugs, chemicals, blood, blood products, prevent misuse of dangerous drugs, regulate the sale of drugs through licenses, prevent adulteration of drugs and provide for punitive action against the offenders.
4. Laws Governing Management of Patients, these are the laws for setting standards and norms for the conduct of medical professional practice, regulating /prohibiting performance of the certain procedure, prevention of unfair practices and control of public health problems /epidemic disease. They deal with the management of emergencies, medico-legal cases and all aspects related thereto including dying declaration, and conduct of autopsy and the types of Professional negligence.
5. Laws Governing Environmental Safety, these are the laws aimed at protection of the environment through the prevention of air, water, surface, noise pollution and punishment of offenders.

A hospital administrator should be aware of the licenses that are essentially required and to renew them as and when required. Periodic Reports and Returns as legal commitment he should be aware of the reports and returns that are essentially required by different agencies with fixed periodicity.

The health legislations are very few as compared to the size and problems in the health care sector. There is a need for having a comprehensive health care act, framed in order to gear the entire health care sector to the objectives laid down in the different policy in India. Most of the common medico-legal situations arise out of non-compliance with these rules and regulations. If a hospital or doctor acquaints well with these rules and regulations and follows them sincerely, he/ she would be on the right side of the law.

Challenges For Organizations and Providers

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.