March Issue 2018
Inside This Issue
Top Five Cancer Trend in 2018 See pg.10
INDEX Mental Health...................... pg.3 Oncology Research......... pg.4 Financial Forecast………… pg.5 Pharmacy Corner.............. pg.6 Healthy Heart....................... pg.8
Baylor Scott & White Partners with World Golf Championships – Dell Technologies See pg. 12
Gainsharing Guidance: Clarification on Cost-Savings Arrangements
By Marissa R. Urban, JD and Gabriel Scott, JD Polsinelli, PC
T
he Office of Inspector General of the U.S. Department of Health and Human Services (“OIG”) recently posted the first advisory opinion interpreting a gainsharing arrangement since recent amendments to the Civil Monetary Penalties Law (CMP) limited CMP’s prohibition on gainsharing arrangements to only those involving reductions or limits in medically necessary services, rather than all services. In Advisory Opinion 17-09 (the “Opinion”), the OIG analyzes a gainsharing arrangement (the “Arrangement”) between a non-profit hospital (“Hospital”) and spinal surgeons (“Neurosurgeons”) in a multispecialty physician practice (“Group”) under which Hospital pays Group a share of cost savings associated with adhering to guidelines on the proper use (and reduction in unnecessary use) of bone morphogenetic protein and use of standardized products during surgeries. Cost savings are calculated based on comparing historic out-of-pocket costs (“Base Year”) to current costs. The Opinion states that the OIG will not impose sanctions in connection with the Arrangement under the CMP or the Anti- Kickback Statute (“AKS”), even though the Arrangement implicates both laws. The Opinion discusses several factors that reduce the risk under the CMP and AKS and that industry players may consider in structuring future gainsharing arrangements. Gainsharing CMP – The OIG states that the Arrangement implicates
the Gainsharing CMP because Neurosurgeons may be incentivized to reduce or limit medically necessary services in exchange for cost savings. However, the OIG states that while it cannot opine on whether the Arrangement reduces only medically unnecessary services, it finds that Hospital monitoring and the methodology used to develop the cost-saving recommendations reduces the risk of unlawful reductions in care. AKS – The OIG states that the Arrangement implicates the AKS because remuneration flows indirectly from Hospital to Neurosurgeons under the Arrangement, which may induce or reward referrals. However, the OIG found the following safeguards, among others, to mitigate referral incentives: • Cost-saving amounts are capped based on, among other things, Base Year surgeries performed for Federal health care program beneficiaries and are distributed on a per capita basis • The Arrangement monitors current patient mix against historic patient mix to prevent and identify cherry-picking of patients to increase cost savings
• Preferred products were selected, and associated use guidelines developed, for the Arrangement based on U.S. Food and Drug Administration guidelines and a evidence-based medical review by Neurosurgeons • Cost-savings are calculated based on actual, verifiable cost savings attributable to the Arrangement and the use recommendations • Neurosurgeons continue to make patient-by-patient determinations as to the best product • The Arrangement is limited to Group Neurosurgeons only The Arrangement also includes a number of facts not addressed in prior gainsharing arrangements approved by the OIG. First, the Arrangement does not prohibit participants from increasing referrals to Hospital, although referral increases are capped at Base Year amounts. Second, patients must receive written notice of the Arrangement (and compensation relationship) prior to admission, where possible. It is unclear whether this feature
see Gainsharing... page 16
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