OIG Soliciting Recommendations on New Safe Harbors To The Anti-Kickback Statute; Stakeholder Comments on Developing Special Fraud Alerts

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Each year the HHS Office of Inspector General (OIG) solicits recommendations for new or modified safe harbor provisions under the Anti-Kickback statute, as well as comments on developing Special Fraud Alerts. Comments to OIG’s Solicitation of New Safe Harbors and Special Fraud Alerts are due by March 2, 2015.

The Anti-Kickback statute makes it a criminal offense to “knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a Federal health care program.” Remuneration under the statute includes the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind.

The statute has also been interpreted to cover any arrangement where even one purpose of the remuneration was to obtain money for the referral of services or to induce further referrals. The Officer of Inspector General (OIG) has recognized the fact that the law is “extremely broad” and has developed safe harbor provisions to “limit the reach of the statute somewhat by permitting certain non-abusive arrangements, while encouraging beneficial and innocuous arrangements.”  

In fact, there are currently 25 regulatory safe harbors under 42 CFR 1001.952 – Exceptions. As you can see from the list, plenty of common arrangements could potentially raise questions under the far-reaching statute. 

Safe Harbors to the Anti-Kickback Statute

Investment interests

Price reduction offered to health plans

Space rental

Practitioner recruitment

Equipment rental

Obstetrical malpractice insurance subsidies

Personal services and management contracts

Investment in group practices

Sale of practice

Cooperative hospital service organizations

Referral services

Ambulatory Surgical Centers


Referral arrangements for specialty services


Price reductions offered to eligible managed care organizations


Price reductions offered by contractors with substantial financial risk to managed care organizations

Group Purchasing Organizations

Ambulance replenishing

Waiver of beneficiary coinsurance and deductible amounts

Health centers

Increased coverage, reduced cost-sharing amounts, or reduced premium amounts offered by health plans

Electronic prescribing items and services


Electronic health records items and services


 OIG Comment Opportunity

Each year, in accordance with section 205 of HIPAA, OIG makes a call for comments to modify or potentially add new safe harbors to the list. The Office states that they will consider a number of factors in reviewing proposals for new or modified safe harbor provisions, such as the extent to which the proposals would affect an increase or decrease in:

  • Access to health care services,
  • the quality of health care services,
  • patient freedom of choice among health care providers,
  • competition among health care providers,
  • the cost to Federal health care programs,
  • the potential overutilization of health care services, and
  • the ability of health care facilities to provide services in medically underserved areas or to medically underserved populations. 

In addition, OIG will also consider other factors, including, for example, the existence (or nonexistence) of any potential financial benefit to health care professionals or providers that may take into account their decisions whether to (1) order a health care item or service or (2) arrange for a referral of health care items or services to a particular practitioner or provider. 

In OIG’s last report to Congress, they identified three comments from last year’s solicitation, as well as OIG’s responses (p. 99, comments in bold, followed by answer):

(1) A new safe harbor protecting free continuing medical education (CME) programs offered by hospitals to physicians. OIG is not adopting this suggestion. The concept of free programs could vary greatly and should be addressed on a case-by-case basis, such as under the advisory opinion process.

(2) A new safe harbor that would permit health care providers and suppliers in certain circumstances to compensate individuals in clinical trials and to provide services related to the clinical trials at no cost, including the waiver of cost-sharing obligations. OIG is considering the adoption of a safe harbor that would protect the waiver of cost-sharing obligations and possibly other incentives to participants in clinical trials sponsored by certain Federal Government entities.

(3) A new safe harbor protecting clinically integrated networks’ (CINs) entry into contracts with commercial third party payors for value-based payments, including pay-for performance bonuses and shared savings awards for high quality and cost-effective health care. The issues raised in the proposal require further study.

Comments are due to OIG by March 2. In commenting, refer to file code OIG–123–N. You may submit electronic comments on specific recommendations and proposals through the Federal eRulemaking Portal at http://www.regulations.gov.

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