Who Is the IG and Why Should I Care?
ACR members have a vested interest in the decisions and positions taken by the Inspector General.
In the medical world, IG is the abbreviation for the Inspector General of the U.S. Department of Health and Human Services (HHS). Radiologists should be concerned with and understand the role of the IG because he or she has immense power and influence in the medical payment world.
The IG's long arm has reached and will continue to reach toward your profession. For years, the IG has collaborated with federal prosecutors to penalize many radiologists and radiation oncologists, as well as their practices, for violating such laws as the anti-kickback and false claims statues.1
Congress established the Office of the HHS Inspector General (OIG) in 1976 under the Department of Health Education and Welfare, which was the first federal agency to have an IG. The legislation focused on ensuring the IG's independence and objectivity with direct access to all HHS records and other information and subpoena power to obtain information and documents outside of HHS.
The HHS IG, who is currently Daniel R. Levinson, is appointed by the president and confirmed by the Senate. The IG reports to the secretary of HHS, but is largely independent. By law, the secretary cannot prevent or prohibit the IG from initiating, carrying out, or completing any audit or investigation. Richard Kusserow, HHS's first IG, referred to his office as the "junkyard dog" to underscore the OIG's zeal in safeguarding the integrity of all HHS programs and pursuing alleged misfeasance.
The power and involvement of the IG in government programs is unparalleled. The OIG's stated mission is "to protect the integrity of ... HHS programs as well as the health and welfare of program beneficiaries." According to the OIG website, the "HHS OIG is the largest inspector general's office in the federal government, with more than 1,700 employees dedicated to combating fraud, waste, and abuse and to improving the efficiency of HHS programs.
The majority of the OIG's resources are invested in the oversight of Medicare and Medicaid — programs that represent a significant part of the federal budget and affect the country's most vulnerable citizens. OIG's oversight extends to programs under other HHS institutions, including the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration." The OIG comprises six sections: the Immediate Office of the IG, the Office of Audit Services, the Office of Evaluation and Inspections, the Office of Management and Policy, the Office of Investigations, and the Office of the Counsel to the IG.
Supporting the tremendous influence of the OIG, its lawyers play an instrumental role in their client's large arena. They consult with investigators, auditors, and inspectors on strategy and tactics regarding current and future initiatives. OIG counselors litigate — together with the Department of Justice and local U.S. attorney's offices — criminal, civil, and administrative cases against physicians and other health-care professionals. Notably, OIG lawyers have issued several advisory opinions on whether radiology and radiation oncology financial arrangements would comply with fraud and abuse laws and regulations. OIG's counsel has a branch of attorneys who issue advisory opinions regarding current or planned arrangements among physicians and between physicians and hospitals. The OIG emphasizes that its opinions apply only to the parties involved in a specific arrangement. Yet the opinions reflect the government's views on broad health-care legal issues, and thus can matter significantly to many physicians. For example, the advisory opinion branch of the OIG's Office of Counsel has authored opinions that concluded radiologists would not be subject to sanctions for offering prior authorization of imaging services for patients and referring physicians.
In addition to releasing influential opinions about physician practices, OIG lawyers have also produced the model compliance guidance documents that advise physicians in freestanding practices and hospitals about key risk areas and how to establish feasible compliance plans. In 2011, the OIG rolled out a physician education brochure addressing physicians' responsibilities to comply with fraud and abuse laws and a PowerPoint slide set with notes. If you treat or diagnose imaging studies of federal program beneficiaries — and most of you do — you should read this informative overview of your legal obligations.
Aside from the opinions generated by the OIG's lawyers, the office's health policy initiatives also affect ACR members. For example, the Obama Administration has begun to launch its controversial concept of accountable care organizations (ACOs). A central legal piece of the ACO platform includes the OIG's fraud and abuse interim final rule. OIG has decided to permit ACOs, ACO participants such as radiologists and radiation oncologists, and ACO providers and suppliers to apply for what amounts to a get-out-of-jail-free card — waivers of IG anti-kickback and CMS self-referral regulations.
OIG also touches you and your practice through its annual work plan. This playbook of upcoming top projects often features investigations and audits of radiology and radiation oncology issues. In FY 2012, the OIG is reviewing whether advanced imaging studies payable under Medicare Part B are medically necessary and how Medicare pays for brachytherapy. Additionally, OIG will inspect how data safety and monitoring boards oversee clinical trials.
As you can see, the OIG influences virtually all areas of medicine — from Medicare or federal research to approving and monitoring drugs and medical devices. Notice how the emphasis on preventing fraud, waste, and abuse is a recurrent OIG theme.
1. Shields B, Hoffman T. “Myth vs. Reality.” ACR Bulletin 2006;61(5):9. See also Shields B, Hoffman T. “Responsible Reads” ACR Bulletin 2011;66(9):23.
By Bill Shields, J.D., LL.M., CAE, and Tom Hoffman, J.D., CAE