Advisory Opinion and anti-kickback statute

The Department of Health and Human Services Office of the Inspector General (OIG) has issued an Advisory Opinion (Opinion) in connection with a hospital’s gainsharing arrangement (Arrangement) with a designated group of neurosurgeons who perform spinal fusion surgeries at the hospital. According to the Opinion, the OIG would not impose sanctions because the Arrangement, when viewed in its entirety, is not designed or likely to induce the neurosurgeons to (i) reduce or limit medically necessary services to their Medicare or Medicaid patients, or (ii) increase referrals to the hospital. This Opinion is the latest in a line of earlier advisory opinions to “bless” gainsharing arrangements that meet certain criteria for minimizing the risk of fraud and abuse. Continue Reading OIG Reaffirms Permissibility of Certain Gainsharing Arrangements

Last week, the OIG posted favorable advisory opinion (16-07) regarding a proposed discount program for Part D beneficiaries who are prescribed a statutorily excluded erectile dysfunction drug.  The OIG concluded that while the proposed discount program could potentially generate prohibited remuneration under the anti-kickback statute (“AKS”) if the parties had the requisite intent, the discount program presented no more than a minimal risk of fraud and abuse under the AKS and therefore it would not impose administrative sanctions.

When analyzing the discount program, the OIG cited its September 2014 Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons, and reminded readers that copayment coupons constitute remuneration and can implicated the AKS.  The OIG then explained that coupons may induce the purchase of federally reimbursable items in two ways: first, if the coupon reduces a beneficiary’s copayment on a federally reimbursable items, and second, if beneficiaries are induced to purchase other federally reimbursable products (not covered by the coupon) from the entity issuing the coupons. Continue Reading OIG Advisory Opinion Approves Drug Discount Program