Given that this is our last issue of 2018, we decided to focus on several important topics that never seem to get enough airtime. Therefore, we are featuring articles on privacy, including the new California Consumer Protection Act and other state legislation, controlled substances, including the new SUPPORT Act that was enacted in October, and the risks of global regulatory approvals. Also, as is typical this time of year, we have several new guidance documents to contend with including the DOJ’s revised compliance monitor policy, as well as guidance on Bona Fide Service Fees, Electronic Health Records, and the latest OIG Advisory Opinion covering the provision of free inpatient medication to hospitals and clinics.
FEATURE – PRIVACY
A Modern Renaissance – Privacy in 2018 and Its Continuing Domestic Evolution
By Rebecca L. Rakoski, Esq., Co-founder and Managing Partner of XPAN Law Group, LLC.
Summary: In 2018, the privacy spotlight was on the EU and the GDPR becoming effective. However, as this article outlines, the EU and GDPR are not the only privacy developments life science companies should be following in 2019. Here, in the U.S. at the state level, there are several initiatives that bear watching. tags: Privacy, GDPR, California
Controlled Substances
Swarming on the Opioid Crisis (Part 3): U.S. Lawmakers Adopt a Multifaceted Approach with the SUPPORT Act
By Katherine Norris, Director, Berkeley Research Group
Summary: This is the third article in the series exploring the major themes emerging from recent efforts to combat the ‘opioid crisis’ and their potential impact on drug manufacturers’ compliance programs. In this article, we review key provisions of the SUPPORT Act, which was signed into law on October 24, 2018. tags: opioids, controlled substances Act
Global
Overseas Regulatory Approvals Bring Additional Risks
By Michael Trahar, Director with Forensic Risk Alliance
Summary: Obtaining market authorization for new products in overseas markets is perhaps the most critical risk point that health science companies face. The make-or-break decisions of formulary approval and reimbursement, particularly for high-priced innovative products, gives corrupt regulators maximum leverage over companies that may not have a fully-developed compliance function in place, prior to recruiting and training a sales force. Compliance professionals and senior management must scrutinize the process of product approval because the stakes are high – potentially all profits associated with a product that is corruptly approved may be subject to disgorgement. tags: Reimbursement, fcpa, market authorization, disgorgement
New Guidance
Scaling Back – The DOJ Issues New Guidance Curtailing the Use of Compliance Monitors
By Carolyn Greene, Staff Writer for Policy & Medicine Compliance Update
Summary: It is frequently the case that organizations investigated by the DOJ for alleged criminal wrongdoing, enter into a settlement agreement to resolve the action. These settlement agreements frequently contain provisions for compliance monitors, which are third parties brought in to the organization to ensure compliance with the terms of the settlement agreements. While helpful in many instances, such compliance monitors are also intrusive and expensive. In response to industry concerns that compliance monitorships are required in cases where they are unnecessary, the DOJ has issued new guidance curtailing the use of such monitorships and providing organizations subject to such investigations with guidance on how to avoid the need for such a monitorship in a settlement agreement. tags: doj, compliance MONITORS, SETTLEMENT agreements
A Tale of Bona Fide Service Fees for PBMs – The Express Scripts Saga
Robert N. Wilkey, Esq., Staff Writer for Policy & Medicine Compliance Update
Summary: A recent legal case is highlighting the extent by Pharmacy Benefit Management (PBM) Organizations, particularly Express Scripts, are coming under heavy scrutiny on multiple fronts for allegedly violating CMS’s various regulatory rules and guidelines relating to Bona Fide Service Fees. In fact, one pharmacy services administrative organization is seeking to publicly bring attention to Express Scripts purported onerous and anti-competitive rebate and BFSF business model, and in so doing, is putting increased pressure on all PBMs to be transparent and open with respect to their pricing arrangements. tags: pbm, service fees, cms
Charitable Skepticism Continues – HHS OIG Nixes Plan to Provide Free Meds to Hospitals
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer for the Policy & Medicine Compliance Update.
Summary: In November 2018, the HHS OIG released its latest advisory opinion. The unfavorable opinion was in response to a prescription manufacturer’s plan to provide free medications for inpatient admissions and even on discharge. This article analyses the latest response to manufacturer supported charitable activities tags: advisory opinion, free drug, charitable activities, inpatient
SHORT: Electronic Health Records & Clinical Research
by David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA Healthcare
Summary: In late July 2018, the FDA issued guidance outlining the criteria for using EHRs in the clinical research involving drugs, biologics and medical devices. For compliance professionals working in the research arena, this guidance is a must read. tags: EHR, Research, FDA