Post on 18-Jan-2018
description
Enforcement Trends in the Pharmaceutical Industry
Lewis MorrisLewis MorrisChief CounselChief Counsel
Office of Inspector General, DHHSOffice of Inspector General, DHHS
Overview
Review of OIG work related to Medicaid and Medicare Part B drugs
Describe OIG priorities in response to MMA
Discuss preventative measures you may wish to consider
Review of 340B Drug Prices Objective: determine if 340B drug pricing
program participants received the required discount prices.
Method: compare CMS’ calculations of the ceiling price to the invoice prices paid by 37 sampled providers.
Findings: Identified significant discrepancies between invoice prices and 340B ceiling prices.
Review of 340B Drug Prices
Problems identified with the underlying data after the report’s release OIG was given ceiling prices for the wrong
time period Questions regarding application of
package size information in the ceiling price calculation
Conducting a more systemic review of the accuracy and completeness of the data used to calculate 340B prices
Completed MMA-related Work
Civil Monetary Penalties related to Medicare-endorsed drug discount cards.
Guidance on outreach efforts between endorsed card sponsors and network pharmacies.
Review of end stage renal disease (ESRD) drug costs
Additional OIG Work Related to MMA
Monitoring Part B Prices (AWP Reform) Utilization of Drugs and Services Access to Drugs Competitive Bidding Process Part D Drug Benefit Calculation of Aver. Mnf. Price
Troubling Industry Practices Misreporting wholesale prices and
marketed the “spread” Suppressing negative research findings
on a product Knowingly failing to report price
concessions made to purchasers Offering and giving physicians kickbacks
to induce the ordering of products
Additional Troubling Practices “Wining and dining” high prescribers Excessive consultant fees Free samples that are to be billed to the
health care programs. Illegal promotion of off-label uses Part D Discount card fraud Providing bogus research grants
Suggested Compliance Self-Assessment Questions Does the compliance office substantial
authority and adequate resources? Is the board of directors well informed
about the compliance function? Has the company too narrowly
construed the compliance function?
Suggested Compliance Self-Assessment Questions Has the organization inappropriately
limited what are considered “compliance issues”?
Have you considered the structure of the organization when designing compliance training?
Do you know your company’s pricing practices and systems?
Suggested Compliance Self-Assessment Questions Do you understand the marketing
techniques available to your sales force, and the procedures required to use those tools?
Do you know what message is being delivered about your products?
What steps are taken in instances of non-compliance?