The Department of Health and Human Services Office of Inspector General (“OIG”) is currently soliciting proposals and recommendations for additional Anti-Kickback Statute safe harbors and OIG Special Fraud Alerts.1 The Health Insurance Portability and Accountability Act requires an annual notice period to solicit these comments in order to identify and protect non-abusive arrangements from the Anti-Kickback Statute. Comments are due to OIG by February 22, 2016.

Background

The Anti-Kickback Statute is a criminal law that prohibits someone from knowingly and willfully soliciting, receiving, offering or paying remuneration in exchange for or to induce federal health care program referrals or business. Because the Anti-Kickback Statute on its face is very broad, OIG solicits these comments to quell the concern that “has been expressed for many years that some relatively innocuous commercial arrangements may be subject to criminal prosecution or administrative sanction.”

Recommendations for Submitting Comments

Comments may be targeted at modifying an existing safe harbor or adopting new safe harbors aimed at addressing current, non-abusive arrangements that health care entities are currently pursuing, such as a safe harbor for participation in CMS-sponsored innovation programs or similar initiatives.

Proposals and recommendations regarding new or revised safe harbors and Special Fraud Alerts are due to OIG by February 22, 2016 at 5:00 PM. Comments may be submitted by mail, hand delivered or submitted electronically at http://regulations.gov. Commenters should reference file code “OIG-124-N” in their submissions to ensure their comments are considered.

When considering proposals for additional or modified safe harbor provisions, OIG reviews how the proposal would affect an increase or decrease in:

  • Access to health care services;
  • Quality of health care services;
  • Patient freedom of choice among health care providers;
  • Competition among health care providers;
  • Cost to federal health care programs;
  • Potential for overutilization of health care services; and
  • Ability of health care facilities to provide services in medically underserved areas or to medically underserved populations.

Note that OIG is not seeking additional public comment on the proposals that were received when OIG last published a Federal Register solicitation notice for developing new safe harbor and Special Fraud Alerts on December 30, 2014. These proposals are listed in Appendix F of OIG’s Fall 2015 Semiannual Report.