Question

Management’s remedial steps to reverse the non-compliance organizations

Answer 1

One of the major differences between the Stark Law and the AKS is the type and degree of each law’s associated penalties. Given that the AKS includes both civil and criminal penalties, and that intent of violating this law has to be proven, the consequences are more severe than those of the Stark Law. Civil penalties of the AKS include False Claims Act liability, civil monetary penalties (CMP) and program exclusion, up to $50,000 CMP per violation, and civil assessment of up to three times the amount of kickback. If the AKS is addressing criminal penalties, the consequences include fines up to $25,000 per violation and up to a five-year prison term per violation.

Stark Law consequences may not be as severe as the AKS, but they can still cost physicians much more in damage than they might have been receiving in reward to begin with. Civil penalties for the Stark Law include overpayment/refund obligation, False Claims Act liability, civil monetary penalties and program exclusion for violations where there was an intent, up to $15,000 CMP for each service, and a civil assessment of up to three times the amount claimed.

How to Ensure Compliance with Stark Law and Anti-Kickback Policies and Procedures

Although the consequences of violating these laws are no small matter, there are many policies, procedures, and practices available to help health care organizations remain compliant with both the Stark Law and the AKS. The most overarching way organizations can maintain compliance with these laws is by ensuring their compliance programs are effective and operating as recommended by the Department of Health and Human Services Office of Inspector General (OIG). In the OIG’s Compliance Program Guidance documents¹, there are seven key elements of an effective compliance program including:

Implementing written policies, procedures and standards of conduct.

Designating a compliance officer and compliance committee.

Conducting effective training and education.

Developing effective lines of communication.

Conducting internal monitoring and auditing.

Enforcing standards through well-publicized disciplinary guidelines.

Responding promptly to detected offenses and undertaking corrective action.

The most notable of these elements as it relates to compliance with the Stark Law and the AKS is implementing written policies, procedures and standards of conduct. By following necessary policies and procedures for these laws, health care organizations can avoid instances of improper referrals and other remuneration fraud or abuse. Compliance Resource Center’s Policy Resource Center (PRC) is a beneficial resource for health care organizations that want to make sure they have the right policies and procedures in place to stay compliant with the Stark Law and the AKS. The PRC houses hundreds of customizable policy and procedure templates that cover Stark Law and AKS, along with a variety of other compliance topics. Included under documents and templates for these laws, the PRC has policies for gifts, joint ventures, patients, physician arrangements, physician recruitment, safe harbors, and vendor relationship

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