HHS Opens Comment Period for Anti-Kickback “Safe Harbor” Provisions
The Department of Health and Human Services is asking for input and comments on the creation of new anti-kickback “safe harbor” provisions and fraud alerts. HHS is expecting the new provisions to address a “broad” statute found within the Social Security Act that imposes criminal penalties on those who defraud federal healthcare programs.
The Safe Harbor Provision
The safe harbor provides compliant healthcare providers and others with assurance that their business practices will not be subject to liability under the anti-kickback statute, or any related administrative authorities. HHS is concerned that since the statute is so broad, “relatively innocuous commercial arrangements may be subject to criminal prosecution or administrative sanction.” The “safe harbor” provisions currently in effect were developed to limit the reach of the statute while allowing non-abusive arrangements to continue and encourage “beneficial and innocuous arrangements.”
When developing safe harbors for a criminal statute, HHS Office of Inspector General (OIG) is required to review the range of factual circumstances that may fall within the proposed safe harbor area so they will be able to uncover any potential opportunities for fraud and abuse. After reviewing any potential loopholes, OIG can work with the Department of Justice (DOJ) to determine whether it can develop regulatory controls that will permit beneficial and innocuous arrangements, while at the same time, protecting Federal healthcare programs and their beneficiaries from abusive practices.
OIG Special Fraud Alerts
HHS is also asking for input on developing new OIG Special Fraud Alerts. OIG occasionally sends out Special Fraud Alerts to provide guidance to healthcare providers with respect to practices that OIG finds potentially fraudulent or abusive. The Alerts work to encourage compliance within the industry by giving guidance to providers that can be applied to their individual practices. OIG Special Fraud Alerts are to be distributed throughout the healthcare provider community, as well as to those responsible for administering Federal healthcare programs.
When OIG develops and issues these Special Fraud Alerts, they rely on a variety of sources and consult directly with experts in relevant subject fields. OIG considers what consequences might result from a new Special Fraud Alert, complete with an analysis of the volume and frequency of any consequences. To help OIG configure future Special Fraud Alerts,
HIPAA Requirements and Factors Taken Into Consideration
This request for input is an annual request, as the Health Insurance Portability and Accountability Act (HIPAA) requires OIG to publish annual documents in the Federal Register, soliciting proposals to modify the existing safe harbors to the anti-kickback statute and for developing new safe harbors and Special Fraud Alerts.
CMS has announced that when they review public comments on the provisions, they will take into account several factors, including the quality of the healthcare, patient freedom of choice, competition among providers, and the cost to federal healthcare programs. Other factors CMS plans to consider are the existence of potential financial benefits to healthcare professionals or providers they may take into account when deciding whether to (1) order a healthcare item or service, or (2) arrange for a referral of healthcare items or services to a particular practitioner or provider.
Comments are due to CMS by February 22, 2016, and can be submitted here. In 2015, the OIG addressed comments in received in response to last year’s solicitation notice in Appendix F of the Fall 2015 Semiannual Report.