Dianne De La Mare
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, amending the safe harbors to the Anti-Kickback statue by adding new safe harbors that protect certain payment practices and business arrangements from sanctions under the statute. The final rule also amends the civil money penalty (CMP) rules by codifying revisions to the definition of “remuneration” added by the Balanced Budget Act (BBA) of 1997 and the Affordable Care Act (ACA).
Specifically, the rule adds new safe harbors to protect the following arrangements from Anti-Kickback liability:
1) certain free or discounted local patient transportation;
2) arrangements between federally qualified health centers (FQHCs) and Medicare Advantage Organizations (MAOs); and
3) discounts to beneficiaries under the Medicare Coverage Gap Discount Program.
The rule also adds the following new regulatory exceptions to the definition of remuneration:
1) reduced copayments by hospitals to patients for certain outpatient department service;
2) remuneration that both promotes access to care for beneficiaries and poses a low risk of harm to patients and federal health care programs;
3) coupons, rebates or other retailer reward programs that are offered on equal terms to the general public and are not tied to the provision of other services reimbursed by Medicare or Medicaid programs;
4) offers or transfers to beneficiaries items and services for free or less than fair market value; and
5) copayment waivers by a Medicare Part D Plan sponsor for the first fill of generic drugs.
Lastly, AHCA/NCAL was pleased that OIG incorporated the Association’s comments, revising the definition of “established patient” to encompass situations where a resident has selected a provider but has not yet been formally admitted. Thus, permitting transportation services by a skilled nursing facility (SNF) where the patient has selected the SNF but not yet been formally admitted. For more information see Reed Smith article.