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Without much ado, the American Office of Inspector General (OIG) has published the General Compliance Program Guidance (GCPG). This guide is intended for use by several segments of the health care sector, such as hospitals, nursing homes, medical equipment suppliers, among others. Its objective is to encourage the development and use of internal control resources, in order to monitor compliance with provisions of applicable statutes, regulations, and programs.

The guide is a very well written document that should be read by all those working in the healthcare sector, as it consolidates the regulatory framework of rules imposed on the healthcare business in the United States. By analogy, it would be as if the Ministry of Health or the Brazilian FDA (ANVISA) published a guide with the main regulatory standards imposed on the health care sector, covering laws, provisional measures, or administrative acts such as resolutions, or ordinances, for instance.

With no doubt, it is an initiative that makes it easier for society in general to know and comply with the US regulatory scenario.

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The guide is divided into the following sections:

GCPG SECTIONS

1. Introduction

2. Health Care Fraud Enforcement and Other Standards: Overview of Certain Federal Laws

3. Compliance Program Infrastructure: The Seven Elements

4. Compliance Program Adaptations for Small and Large Entities

5. Other Compliance Considerations

6. OIG Resources and Processes

7. Conclusion

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In the opening section, “Introduction,” the guide describes the efforts undertaken since 1976 by the OIG. These efforts involve creating compliance documents and guidelines directed at hospitals; home health agencies; clinical laboratories; third-party medical billing companies; durable medical equipment, prosthetics, orthotics, and supply industry; Medicare Advantage organizations; hospices; nursing facilities; physicians; ambulance suppliers; and pharmaceutical manufacturers.

In the second section “Health Care Fraud Enforcement and Other Standards: Overview of Certain Federal Laws”, the guide provides an important analysis of the Anti-Kickback Statute, which defines the crimes committed in the health care sector. The False Claims Act is also examined, which regulates the civil liability of those who commit illegal acts and which penalizes public health care programs, providing for the innovative action qui tam, in which the citizen can litigate in the role of the State, receiving a percentage of up to 30% of the conviction.

It also provides an analysis of the Stark Law, which regulates physician's prescriptions for certain health care services paid for by the federal health care program Medicare with which the physician has a commercial relationship, in addition to providing various authorities with whom the OIG can interact in the application of penalties. The exclusion register of companies and individuals, Criminal Health Care Fraud Statute, is also brought to light, equally applicable to fraud regarding benefits of federal health care programs and the security and privacy rules established by the Health Insurance Portability and Accountability Act (HIPAA) from 1996.

The third section “Compliance Program Infrastructure: The Seven Elements,” details each of the elements that, in the OIG’s judgment, are important to defining a solid compliance program. They are listed below:

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COMPLIANCE PROGRAM ELEMENTS

1. Code of Conduct and Compliance Policies and Procedures

2. Compliance Leadership and Oversight

3. Training and Education

4. Effective Lines of Communication with the Compliance Officer and Disclosure Programs

5. Enforcing Standards: Consequences and Incentives

6. Risk Assessments, Auditing, and Monitoring

7. Responding to Detected Offenses and Developing Corrective Action Initiatives

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The fourth section “Compliance Program Adaptations for Small and Large Entities” states what would be expected from an efficient compliance program for small entities. In addition, governance principles are established for compliance in large organizations, in order to consolidate a compliance culture led by example. I highly recommend reading this section.

The fifth section “Other Compliance Considerations” covers important aspects to be mindful of from a compliance perspective. These include quality and patient safety, new entrants in the health care industry, financial incentives: ownership and payment (follow the money), and financial arrangements tracking.

The sixth section “OIG Resources and Processes” provides the entire OIG arsenal of numerous regulatory and compliance resources to help readers correctly follow existing US health care regulations. This includes toolkits, bulletins, publications, opinions, corporate integrity agreements, a summary of penalties applied, a FAQ list with questions and answers that help clarify numerous issues, as well as a reporting channel for health care fraud.

The seventh section “Conclusion” emphasizes the need to adhere to the compliance rules of this market segment that is constantly evolving.

Therefore, reading is essential for those who wish to delve deeper into the regulatory framework for health care in the USA. It can even be used to secure subsidies when compared to the existing regulatory framework in Brazil, although the Brazilian Public Healthcare System (SUS) is radically different from American federal health care programs in which, for example, co-payment by the beneficiary is a frequent practice.