Life Science Compliance Update

July

2018

July 2018: Life Science Compliance Update

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Copay Assistance Lands Pfizer Another Corporate Integrity Agreement
By Kaitlin Fallon Wildoner, Esq.
Pfizer is the second company (of perhaps many) to find itself in a new corporate integrity agreement (CIA) over patient assistance programs and independent charities. The CIA entered between Pfizer and HHS-OIG, and the DOJ include some newer language and requirements centering around PAPs and give good insight into what other companies should be looking to do concerning their PAP arrangements.

July 2018 Issue Summary

July 2018 LSCU Cover

If you are looking for a theme for this month, we suggest PAIN. From the opioid crisis to patient copay assistance it seems that despite our best compliance efforts there is no shortage of programs and antics that are resulting in painful outcomes for life science companies.

Speaking of pain, we lead off this month with Katherine Norris’s article on the current swarm of legislation to address the OPIOID CRISIS that is occupying CAPITOL HILL this summer. Following that is an article chronicling CANTRELL DRUG COMPANY’S FIVE-YEAR SAGA with the FDA and now the DOJ for CGMP issues at its COMPOUNDING facility.

Next, we take a look how compliance issues can impact a potential MERGER, especially when serious allegations of non-compliance, especially involving DATA INTEGRITY, come to light after the DUE DILIGENCE process. The court documents in the FRESENIUS/AKORN case give us a rare glimpse into that world.

Moving into the more familiar territory of kickbacks and false claims, we examine the VALEANT and PHILIDOR case which resulted in CRIMINAL CONVICTIONS for executives from both a Valeant and a Philidor. Then there is the Abiomed settlement which involved using expensive meals as inducements 15 years after the PhRMA code. Finally, we wrap it up with a look at Pfizer’s most recent CORPORATE INTEGRITY AGREEMENT involving one of the latest hot button items – PATIENT ASSISTANCE PROGRAMS and INDEPENDENT COPAY CHARITIES.


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Swarming on the Opioid Crisis: Legislative Response Attacks Concerns from All Sides
Katherine Norris
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This is the first article in a series exploring the major themes emerging from recent legislative efforts to combat the ‘opioid crisis’ and their potential impact on drug manufacturers’ compliance programs. Currently, there is a myriad of bills before the U.S. Congress attempting to address the growing epidemic of opioid abuse, misuse, and diversion throughout the United States.

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The Sleeping Giant Awakens – Cantrell’s Consent Decree as a Study on How Not to Respond to FDA Enforcement Actions
Carolyn Greene, Esq.
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Cantrell Drug Company, a 503B outsourcing facility in Little Rock, Arkansas, has been subject to multiple FDA inspections over a five-year period. Each inspection found numerous deficiencies, many in critical areas relating to the prevention of microbiological contamination and aseptic processing. Cantrell defied FDA instructions and shipped products in interstate commerce. As a result, FDA referred the matter to the DOJ, which filed a civil enforcement proceeding seeking to enjoin Cantrell from further distribution. Ultimately, Cantrell entered into a consent decree with the FDA. This case played out much more publicly than similar situations, as Cantrell executives were posting comments on Twitter about the process. Unfortunately, the tone of the comments suggested that Cantrell did not take the FDA’s supervision seriously.

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Compliance Issues Can Scuttle A Deal – The Fresenius/Akorn Acquisition Seems to be the Latest Example
Gwendolyn Ball
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Compliance issues seldom take center stage in major financial deals.  However, the Fresenius/Akorn merger may be collapsing because of Akorn’s deficiencies in complying with FDA data management rules.  While it is not guaranteed that the courts will allow Fresenius to withdraw from the deal, Akorn has already suffered a very public blow to its reputation and a severe hit to its stock price.  The case illustrates how deficiencies in regulatory compliance can not only impact a firm’s relationship with regulatory agencies, but also its long-term financial and strategic planning.

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You Say Marketing Incentive; I Say Kickback – Former Valeant and Philidor Execs Convicted of Fraud in Kickback Scheme
Carolyn Greene, Esq.
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Former executives of Valeant Pharmaceuticals and Philidor Rx Services, a specialty pharmacy, recently went on trial in Manhattan charged with fraud and conspiracy for allegedly engaging in a kickback scheme in which the Valeant executive encouraged Valeant to purchase an option agreement to acquire Philidor. The Philidor executive allegedly personally obtained $40 million from the deal and paid an almost $10 million kickback to the Valeant executive. Both were convicted, and each faces a potentially lengthy prison term at sentencing. In recent years, the DOJ has stepped up enforcement in holding company executives personally liable for corporate malfeasance. However, before this case, the DOJ had little success in obtaining convictions in these cases.

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When “Free” Really Isn’t Free – A Look at the Abiomed Case
Robert N. Wilkey, Esq.
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In March, the United State Department of Justice (DOJ) and U.S. Attorney’s Office for the District of Massachusetts announced a $3.1 million-dollar settlement with Abiomed to resolve allegations that the company was actively using illicit marketing tactics with physicians to increase sales in a manner that violated the AKS and FCA.  Such settlement highlights that there is no such as a free lunch.

June

2018

June 2018: Life Science Compliance Update

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Looking Back – Reviewing OIG’S Report On The Top Management & Performance Challenges For HHS
By Gwendolyn Ball
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Greg Demske’s recent keynote address at Mitchell Hamline’s Health Law Institute Symposium and the OIG’s report on the top management challenges facing HHS published in 2017 provide a remarkably consistent picture of the OIG’s focus and direction. As this article highlights there are no magic bullets to address those challenges.

June 2018 Issue Summary

June 2018 LSCU Cover

As we noted last month, despite the political climate in Washington, life science compliance shows no signs of slowing down.  Here at the Update the writers and editorial staff have been busy shifting through all the developments.

For June, we start out examining MCKESSON’S latest compliance challenge involving allegations of REPACKAGING the overfill from SINGLE-USE VIALS to improve margins but violate the FALSE CLAIMS ACT.  Later on, we take a look at the defeat of Maryland’s pharmaceutical price gouging law for violating the Commerce Clause.

Potomac River Partners takes another look at the OIG-HCCA guidance but from a SMALLER COMPANY’S perspective, and we follow that up with OIG’s thoughts around the TOP MANAGEMENT CHALLENGES facing HHS.

In the area of recurring themes, we take a look at OPDP’s lack of OFF-LABEL activities in 2018 and examine the continuing debate over regulating COMPOUNDING PHARMACIES from the perspective of trying to MEASURE the “PROBLEM.”


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Everything Old is New Again – McKesson Accused of Skimming Cancer Meds in FCA Suit
Carolyn Greene, Esq.
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In response to concerns about the provenance of cancer drugs its providers received from McKesson, Omni has filed an FCA suit alleging that McKesson engaged in a scheme to increase profits illegally on cancer drugs. Specifically, Omni asserts that McKesson harvested and pooled overfill from single-use vials of cancer medications. McKesson then re-packaged these cancer drugs into pre-filled syringes. By collecting the overfill, Omni alleges that McKesson increased the number of doses of the cancer medications. This practice led to adulteration of the drugs themselves, as well as the submission of fraudulent claims to various government agencies for reimbursement on these extra doses of drugs created from the overfill. This case is yet another example of the re-occurring themes of overfill harvesting and “playing the spread” in conjunction with submission of fraudulent claims to the federal government for pharmaceutical reimbursement.

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Finding The Golden Nuggets – OIG-HCCA Recommendations For Smaller Life Science Companies
Carla-Marie Ulerie, Eric Davis, and Jon Wilkenfeld
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Recently the OIG and the HCCA published a resource guide with recommendations for determining if a compliance program is effective. Since small to mid-sized pharma and medical device companies typically operate with limited compliance staff and financial resources, we identified recommendations that were relatively easy or low cost to implement but were rarely adopted. Based on our review we have determined the “golden nuggets” from that guide.

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Maryland Loses Rx Price Gouging Law But Not The Debate
Nicodemo (Nico) Fiorentino, Esq.
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Recently the United States Court of Appeals for the Fourth Circuit overturned Maryland’s law prohibiting price gouging for essential off–patent or generic drugs. This article highlights Maryland’s first-in-the-nation prescription drug price gouging legislation, key points to the commerce clause, and the impact the court’s ruling has on similarly proposed legislation throughout the country.

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Where In The World Is OPDP? Where In The World Is OPDP?
Kaitlin Fallon Wildoner, Esq. and Seth B. Whitelaw, J.D., LL.M, S.J.D.
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OPDP enforcement activities have sharply declined over the past several years. That trend continues in 2018 as OPDP has only issued one letter involving opioids and a conference booth. This article looks at the trend, reviews the most recent letter and tries to determine what this means for compliance and regulatory professionals.

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Solving The Problems With Drug Compounding – Sparse Data And An Inconsistent Regulatory Framework Muddy The Waters
Carolyn Greene
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At least partly in response to the 2012 fungal meningitis outbreak, Congress passed the DQSA to increase federal regulatory authority over compound pharmacies. Many states also joined in the increased FDA regulatory oversight, strengthening their quality requirements. Data on compound drug quality is limited, but the data that does exist depicts an industry with a substantial number of quality and safety problems, potentially endangering the health of millions of Americans. The compound pharmacy industry isn’t helping matters – instead, they insist that compound drugs are safe. Since the passage of the DQSA, significant improvements have been made in the quality and safety of compound drugs, but much work remains.

May

2018

May 2018: Life Science Compliance Update

Written by , Posted in May 2018 LSC Update, This Month in Compliance

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It’s Not Just Money – Theranos & SEC Come to Terms
By Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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On March 14, 2018, the SEC charged Theranos and two of its executives in Silicon Valley with raising more than $700 million from investors through a fraud in which they exaggerated or made false statements about the company’s technology, business, and financial performance. Even though Theranos was a private company, the SEC settlement stands as a cautionary tale to those life science companies seeking financing.

May 2018 Issue Summary

May 2018 LSCU Cover

This definitely is not a slow compliance year and here at the Update, we’ve been busy sifting through all the activities. This month we are featuring an EXCLUSIVE – coverage of GREG DEMSKE’S recent talk at Mitchell Hamline’s Health Law Institute Symposium. We have heard many OIG PRESENTATIONS over the years, but this one was decidedly different.

Carrying on with enforcement, Nicodemo Fiorentino has examined the recent Federal INDICTMENT of five, prominent NEW YORK PHYSICIANS and found the CONNECTION between the ALLEGATIONS and what was reported in OPEN PAYMENTS. We also have taken a look at the recent THERANOS settlement and the SEC noting that even PRIVATE COMPANIES with no marketed products need to be careful with their PUBLIC STATEMENTS.

Shifting gears to the FDA, we have two articles covering the new guidance on HEALTH INFORMATION collected by MEDICAL DEVICES and the new DRAFT GUIDANCE for COMPOUNDING PHARMACIES.

Finally, we finish up with an UPDATE on ALLERGAN’S apparently discredited strategy of using NATIVE AMERICAN TRIBES to expand patent protection.


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Not Your Average OIG Presentation – Greg Demske Defines A “Successful” OIG Based On Fairness, Communication, And Compliance At The Mitchell Hamline Symposium
Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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Recently Greg Demske, Chief Counsel for the Department of Health and Human Services Office of Inspector General provided the keynote address at Mitchell Hamline’s Health Law Institute Symposium, “Hot Topics in Healthcare Compliance.” His speech was noteworthy not because he announced new policies, but rather for its focus and key messages of fairness, communication and compliance.

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Open Payments & Kickbacks: Are Indicted Physicians on Your Company’s Payroll?
Nicodemo Fiorentino, Esq.
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This article uses Open Payments data from the government’s publicly available database to provide a different way of reading the U.S. Government’s recent unsealing of a criminal indictment. The indictment alleges five (5) New York licensed physicians violated, among other laws, the Federal Anti-Kickback Statute for their participation in accepting speaker program fees and other payments in return for prescribing a fentanyl product indicated for the management of breakthrough pain in cancer patients. Additionally, the Government provides evidence that the pharmaceutical company lacked the ability to ensure compliance with U.S. fraud and abuse laws. Compliance and legal departments will want to carefully review the indictment and watch the case closely. It may turn out to be a test case for the Centers for Medicare & Medicaid Services to finally enforce the Physician Payments Sunshine Act and implementing regulations.

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The Intersection Between Patients, Health Information And Devices – New FDA Guidance Attempts To Prevent A Traffic Accident
Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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The rapid of expansion of connected medical devices producing patient-specific health information is the focus of a new FDA guidance document. This article explores the requirements in the guidance and what impact it might have on medical device manufacturers.

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The Wheels of Time Grind Slowly – FDA Issues Draft Guidance For Compound Pharmacy Outsourcing Facilities
Carolyn Greene
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In response to concerns about the safety of compounded drugs, particularly those produced in bulk, Congress passed the DQSA which amended the FFDCA to create a new category of compound pharmacies referred to as “outsourcing facilities.” Outsourcing facilities are subject to heightened FDA regulatory authority compared to traditional compound pharmacies. The FDA has just issued a Draft Guidance outlining some of the new regulations relevant to outsourcing facilities. These regulations limit the drugs that outsourcing facilities may produce in bulk quantities.

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Update – Allergan’s Patent Transfer To Native Americans Lacks Merit
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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In an effort to preclude competitors including generic drug companies from entering the market, many pharmaceutical companies, most notably Allergan PLC (“Allergan”) with its dry-eye medication Restasis has sought to enter into patent transfers with Native American Tribes, taking advantage of sovereign Indian Nation status to thwart off intellectual property challenges and create additional barriers to market entry. In October 2017, a U.S. Federal Court dismissed Allergan’s lawsuit seeking to enforce its Native-American patent partnership, taking issue with Allergan’s seeking to stifle competition by way of seeking refuge by way of Native American sovereign immunity. Seeking further legal relief from the Patent Trial and Appeal Board (“PTAB”) of the U.S. Patent and Trademark Office (“USPTO”), Allergan’s latest efforts to invoke sovereign immunity as the basis to limit generic drug competition has similarly failed.

April

2018

April 2018: Life Science Compliance Update

Written by , Posted in April 2018 LSC Update, This Month in Compliance

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Data Analytics & Detecting Medicare Fraud – A Promising Idea Still Awaiting Proof of Concept
By Gwendolyn Ball
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For analyzing so-called “Big Data” sets, data analytics is an invaluable set of tools and techniques. Now the HHS OIG plans to expand its efforts to use data analytics to detect Medicare fraud. While promising, it remains to be proven that the tool and techniques will be cost-effective in this context.

April 2018 Issue Summary

April 2018 LSCU Cover
If we had to pick a theme for this month’s issue it would be change. First off, we explore the rapidly escalating and changing chorus of voices surrounding DRUG PRICING TRANSPARENCY. Next, we look at the CMS’S efforts to address ALTERNATIVE PAYMENT MECHANISMS in the context of the existing legal and regulatory framework. In the same vein, we explore what DATA ANALYTICS means in the context of detecting and preventing healthcare fraud. On the enforcement front it is the aftermath of MEDTRONIC’S MULTI-STATE SETTLEMENT as well as the latest child of ESCOBAR. Finally, we round out the issue with a look at GUIDANCE DOCUMENTS.

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The Day After Tomorrow – The Drug Pricing Transparency Chorus Grows Louder
Nicodemo Fiorentino, Esq., Member, Life Science Compliance Update Editorial Board
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Drug pricing transparency, as a concept at least, is here to stay. However, the details of what that means and the new obligations that pharmaceutical companies will need to deal with are yet to be determined. For pharmaceutical compliance professionals, 2018 will continue to be a time of high uncertainty and an ever-increasing workload. This article examines the current state and what the future may hold.

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Coming into the Modern Era – CMS Creates Interagency Task Force to Examine Alternative Payment Mechanisms
Gwen Ball, Staff Writer, Life Science Compliance Update
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To control rising costs under Medicare, the Affordable Care Act, and Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) created some “value-based programs” (“VBPs”) which provide incentives for cost cutting while ensuring the quality of patient care. VBPs inherently rely on collaboration between referring physicians and other healthcare providers as well as share Electronic Health Record (“EHR”) systems, thereby conflicting with the old fee-for-service fraud protection provided by the Anti-Kickback Statute and the Stark Law. CMS Administrator Verma recently called for an interagency task force to study removal of these barriers to new, cost-effective methods of healthcare delivery under Medicare. However, the administrator notes that real progress on this issue may require Congressional action as well.

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It’s Not All About the Money – Medtronic’s Infusion Multi-State Settlement Agreement
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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In a closely watched matter culminating years of litigation, Medtronic in December 2017, entered into a $12 Million multi-state settlement resolving allegations that the medical device company had misled consumers about the safety, efficacy, and effectiveness of its Infuse® Bone Graft Device (“Infuse”). The settlement represents continued coordination among States to prosecute marketing fraud and false advertising within the medical device industry.

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The Escobar Hurdle – False Claims, Materiality, and Dismissal
Robert N. Wilkey, Esq.
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U.S. ex rel. Ruckh v. CMC II LLC et al. (“Ruckh”) was a closely followed False Claims Act case, because a Florida Federal Court opted to vacate a nearly $350 Million FCA verdict involving a nursing home operator. The case is significant because it demonstrates the ongoing impact of a party’s failure to meet the Escobar materiality standard.

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The War on Patient Assistance Programs Takes a New Twist – The Tortured History of Caring Voice Coalition
Kaitlin Fallon Wildoner, Esq., and Seth B. Whitelaw, J.D., LL.M, S.J.D.
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In the most recent chapter in the ongoing battle over the priority of patient assistance programs, the Caring Voice Coalition recently announced it would not provide financial assistance for any diseases in 2018. As a result of this announcement, HHS OIG is turning to PhRMA for help.

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The End of Guidance Documents or Simply a Reminder of Well-Established Administrative Law Principles
Kaitlin Fallon Wildoner, Esq., and Seth B. Whitelaw, J.D., LL.M, S.J.D.
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As discussed in several news outlets, the Trump Administration recently announced that it would begin to enforce long-standing administrative law principles and limit the weight guidance documents carry in government actions against private companies and individuals. While the ramifications of this decision are still months away from realization, this article outlines the principles and the possible effects we will see in the future from this decision.

March

2018

March 2018: Life Science Compliance Update

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A Bright Future or Unfulfilled Promise – An Update on Biosimilars and Their Prospects for Contributing to Meaningful Cost Reduction
By George Schroeder, M.D. M.S., FACEP.; Seth Whitelaw, J.D., LL.M., S.J.D.; John Murphy, Esq.
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Biosimilars have a bright future and promise potentially significant health care cost savings, provided the regulatory, legal and commercial hurdles are removed. Recent activity by CVS and United Healthcare are promising signs that indeed the commercial barriers are starting to come down. However, it remains unclear whether the FDA will help on the regulatory front.

March 2018 Issue Summary

March 2018 LSCU Cover

We start out the March issue focusing on false claims. Our feature article discusses the recent Third Circuit case which outlines the minimum need to transform a kickback violation into a false claim. Next, we turn to the FY 2017 settlement figures for insights into the future. Finally, we examine how failing to make timely repayment can increase False Claims Act liability.

Switching gears, we turn to the issue of biosimilars and whether or not they will bring about a meaningful reduction in health care costs both here and abroad. We also examine the FDA’s continued regulatory efforts surrounding stem cells. On a global note, we have an excellent article outlining the new medical representative requirements that are coming online in China. Finally, this issue could also be billed as the Editorial Board member issue as we have articles from three of our members: Nicodemo Fiorentino, Dr. George Schroeder and John Murphy.


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Establishing the Link – The False Claims Act and Temporal Proximity
Nicodemo Fiorentino, Esq., Member, Life Science Compliance Update Editorial Board
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Under the Patient Protection and Affordable Care Act of 2010, a provision was added to significantly strengthen the Federal Anti-Kickback Statute by making a violation of the AKS also a violation of the Federal False Claims Act. Thus, if a relator or government can prove that Anti-Kickback Statute was violated, then it would constitute a false or fraudulent claim under the False Claims Act. But, what type of evidence is needed to connect a kickback to a false or fraudulent claim? A recent United States Court of Appeals for the Third Circuit case, United States ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89 (3d Cir. 2018), answered this question. This article discusses that case and its implications.

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Soldiering On – The False Claims Act Cases Continue to Significantly Impact Life Science Companies in FY 2017
Gwen Ball, Staff Writer, Life Science Compliance Update
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For FY 2017, the Federal False Claim Act continued to be a potent weapon for combating health care fraud by life sciences companies. However, while overall the settlements appeared to hold steady, there were more defendants and smaller settlements. This article explores the FY 2017 data for what it may reveal about the future of FCA cases against life sciences companies.

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Uncle Sam Wants His Money – First Coast Cardiovascular Institute as a Case Study in Repaying Overpayments Can Generate in FCA Liability
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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In October 2017, First Coast Cardiovascular Institute, entered into an almost $450,000 settlement with the DOJ to resolve allegations that it violated the False Claims Act by knowingly delaying repayment of more than $175,000 in overpayments. This settlement involving First Coast is a substantive example of how failing to make timely repayment can bring substantial, additional liability under the FCA. Therefore, it is crucial to ensure timely repayment to and reconcile any overbalances with the U.S. Government.

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The FDA Continues Its Effort to Reign in Rogue Stem Cell Therapy Companies
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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On August 28, 2017, the U.S. Food and Drug Administration (“FDA”) issued a scathing Warning Letter to a U.S. Stem Cell Clinic for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. Although the FDA Warning Letter was directed to a specific stem cell company, many observers note the FDA’s more extensive and broader efforts to regulate, enforce, and otherwise ensure compliance with good stem cell practices and procedures.

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Transforming Health Care in the Middle Kingdom – China’s New Medical Representative Regulation
Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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China is the world’s largest and perhaps most complex economy. As the PRC emerges the world stage, it continues to transform its health care system. This article examines the nature of some of the regulatory reforms impacting the pharmaceutical industry with particular focus on the new medical representative requirements.

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ARTICLE UPDATE: Has the Shine Worn Off False Claims QUI TAM Actions
Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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February

2018

February 2018: Life Science Compliance Update

Written by , Posted in February 2018 LSC Update, This Month in Compliance

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One Purpose to Rule Them All – A Resounding “Yes” According to the District Court in U.S. Ex Rel. Cairns
By Robert N. Wilkey, Esq., Staff Writer and Seth B. Whitelaw, J.D., LL.M., S.J.D., Editor for Life Science Compliance Update
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The breadth of liability under the False Claims Act and Anti-Kickback Statute is a closely watched area. Recently, the U.S District Court for the Eastern District of Missouri concluded that liability might extend to a health care provider even where the plaintiff fails to demonstrate that the “primary purpose” of providing the benefits was to create an inducement. Although the impact of such Court case remains somewhat uncertain, it is expected that the Court’s ruling will continue to expand FCA and AKS liability.

February 2018 Issue Summary

February 2018 LSCU Cover

This month’s issue is focused on three main areas: drug pricing, patient assistance programs and the False Claims Act. As our feature article, Nicodemo Florentino explores the often-overlooked antitrust areas of “shadow pricing” and “conscious parallelism.” Next, we look at the recent settlement by United Therapeutics and its potential impact on patient assistance program charities and how the OIG’s efforts to regulate this area may lead to the next big 1st Amendment battleground.

We then turn our attention recent False Claims Act developments including the one purpose test and the DOJ’s apparent shifting view of qui tam actions.


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Casting Some Light on Shadow Pricing
Nicodemo Fiorentino, Esq.
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Prescription drug prices continue to rise and focus attention on the pharmaceutical industry. Currently the industry faces hearings at the federal level, new legislation at the state level and almost daily media coverage due to this issue. The Sherman Antitrust Act, passed in 1890, is also being used against the industry. Often overlooked, “shadow pricing” and “conscious parallelism” are two ways in which manufacturers allegedly can restrain trade and competition. This article is aimed at helping compliance and legal professionals become familiar with antitrust and how it presents a present and future compliance risk. The article further represents a call for compliance and legal professionals to be involved with how their company sets pricing.

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When Good Intentions Go Astray – United Therapeutics Settles AKS Suit
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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With the United Therapeutics settlement, it is clear that the DOJ remains focused on patient assistance programs and other similar charities. As a result, additional settlements involving these programs are likely to continue in 2018, once more pitting established legal constructs against current fiscal realities.

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Staring Down Another First Amendment Challenge – The OIG vs. Patient Services
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Patient Assistance Programs (“PAPs”) are starting to feel the heat from various United States agencies, as we have noted in several issues over the past year. Recently, Patient Services, Inc., filed suit in response to a Modified Advisory Opinion issued by the HHS OIG. This article outlines the changes and the suit.

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One Purpose to Rule Them All – A Resounding “Yes” According to the District Court in U.S. EX Rel. Cairns
Robert N. Wilkey, Esq., Staff Writer and Seth B. Whitelaw, J.D., LL.M., S.J.D., Editor for Life Science Compliance Update
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The breadth of liability under the False Claims Act and Anti-Kickback Statute is a closely watched area. Recently, the U.S District Court for the Eastern District of Missouri concluded that liability might extend to a health care provider even where the plaintiff fails to demonstrate that the “primary purpose” of providing the benefits was to create an inducement. Although the impact of such Court case remains somewhat uncertain, it is expected that the Court’s ruling will continue to expand FCA and AKS liability.

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Revisiting the Past – Warner Chilcott vs. Insys
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Those who remember the Warner Chilcott and W. Carl Reichel case from just two years ago may have had déjà vu when they heard about the recent legal controversy surrounding John N. Kapoor and Insys. This article reviews the current Insys and Kapoor developments and compares the two cases to analyze whether the trend of involving high-ranking executives is the future of enforcement.

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Has the Shine Worn Off False Claims QUI TAM Actions
Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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At the recent HCCA Annual Conference, the Deputy Director of DOJ’s Civil Fraud Section may have signaled a change in policy relative to handling qui tam cases. This article explores the issue and what it might mean for life science companies going forward.

January

2018

January 2018: Life Science Compliance Update

Written by , Posted in January 2018 LSC Update, This Month in Compliance

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The Monster in the Closet – New WHO Report Shines a Light on the Problem of Substandard & Falsified Medicines
By Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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The issue of substandard and counterfeit medicines has been known for some time. Since it is not often discussed openly, it is difficult to get an appreciation for the scope of the problem. However, a new WHO report, backed by four years’ worth of data, sheds some light on the matter and gives some guidance on how to identify likely problems and respond to them.

January 2018 Issue Summary

January 2018 LSCU Cover
Happy New Year everyone! As we start off 2018, we thought it was appropriate to think about New Year’s Resolutions, and so our feature article this month discusses the need to assess the company culture and possible ways to do it. Then in the spirit of holiday giving, we examine the 2017 OIG enforcement data to see what that bodes for 2018 and we see what the DOJ brought us in the form of a permanent FCPA Pilot Program. Finally, in keeping with the fact that life sciences is a global industry, we examine the new GPDR requirements in the EU, which are set to take effect in May 2018, as well as the unsettling WHO report on substandard and falsified medicines.

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A Compliance New Year’s Resolution – Assess the Company’s Culture
Jenny McVey, Associate Director and Frances McLeod, Founding Partner, FRA
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The topic of ‘company culture’ is certainly not new, but it continually emerges as a hot topic within regulatory circles. An organization’s culture is recognized to exert a powerful influence on how a company and its people conduct business. Although there is an inherent understanding that by continually enhancing company culture, ethical aspects of the organization will follow suit, why isn’t culture reviewed with the same rigor and principles that are required for compliance programs? This article will discuss the importance to evaluate an organization’s culture of compliance, and will introduce some considerations on how this can be done.

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Like the Little Drummer Boy, the Beat Goes on as OIG Enforcement Shows Few Signs of Letting Up
Kristen Schwendinger, Senior Managing Consultant, Berkley Research Group
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As life science compliance professionals know, it is important to monitor what the HHS OIG focuses on. This article reviews the OIG’s focus in 2017 and looks ahead to what may be in store for 2018.

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Christmas Comes Early – The FCPA Pilot Program Made Permanent
Jenny McVey, Associate Director, Forensic Risk Alliance
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When we first introduced the FCPA Pilot Program in the June 2016 issue, we noted the uncertainties of outcomes for companies who voluntarily self-disclose potential violations. On November 29, 2017, Deputy Attorney General Rod Rosenstein announced that the US Department of Justice (DOJ) had made the FCPA Pilot Program permanent. This article will review some of the key highlights outlined by the DOJ and some considerations for compliance professionals.

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Privacy Upheaval – Exploring the Impact of the GDPR on Companies Sponsoring and Managing Global Clinical Research
By Michelle Wilcox DeBarge, Partner, Wiggin and Dana LLP
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In May 2018, the new European Union (“EU”) General Data Protection Regulation (“GDPR”) will replace the familiar Data Protection Directive. In addition to significant new penalties, the GDPR requires companies to examine and rethink their data strategies, especially when working with clinical trials. This article discusses key considerations in implementing the GDPR for companies sponsoring and managing clinical trials.

December

2017

December 2017: Life Science Compliance Update

Written by , Posted in December 2017 LSC Update, This Month in Compliance

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December 2017 LSCU Cover

Issue Summary

For much of 2017, we have focused on ENFORCEMENT issues. While the December issue no exception, we also are focusing on topics that impact COMPLIANCE OPERATIONS. Therefore, we are featuring an article by Sean Murphy and Lauren Barnett of PharmaCertify on enhancing COMPLIANCE LEARNING to maximize RETENTION. We also examine the challenges faced by Novartis’ GLOBAL COMPLIANCE FUNCTION and the dangers of EXAGGERATING BILLING CODES.
In the case of new developments impacting compliance operations, we take a look at FDA’s work plan to implement the 21st CENTURY CURES ACT, as well as Allergan’s attempted use of NATIVE AMERICAN SOVEREIGNITY to protect its PATENT position.
Of course, no issue would be complete, without the ENFORCEMENT roundup. This month we look at MYLAN’s recent EPIPEN settlement, AMERISOURCE BERGEN’S continuing FALSE CLAIMS and FDA compliance woes.


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Learning After You Know It All – Enhancing Compliance Learning and Maximizing Retention
Sean Murphy and Lauren Barnett of PharmaCertify™ by NXLevel Solutions

Research shows that as much as 80% of the information learned in an instructor-led event, or eLearning course is rapidly forgotten. Even after the information is transferred to a learner’s working memory, storage of that information decays if it is not recalled and re-encoded. When the key concepts, policies, and best-practices presented in life sciences compliance training are forgotten soon after training events are completed, the organizational risk rises dramatically, and compliance cultures are weakened. By contrast, a continuous learning approach to compliance training incorporates four evidence-based strategies (review and reinforcement, gamification, microlearning, and assessments) into the delivery of learning components. When training is deployed strategically and continuously across a leaner’s timeline, engagement levels rise, retention is maximized, and global risk is reduced.

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The Ongoing Struggles of Novartis’ Global Compliance Function
Robert N. Wilkey, Esq., Staff Writer and Seth Whitelaw, J.D., LL.M., S.J.D., Editor for Life Science Compliance Update

In recent months, the pharmaceutical company Novartis, has been hit with some high profile international corruption scandals in South Korea and Greece. Although such large-scale scandals involving pharmaceutical and medical device companies is nothing new, the Novartis case study brings to light the challenges of providing effective compliance for life science companies actively engaged in market expansion abroad. In this article, we will briefly examine how Novartis is working to address those challenges. However, in the end, meeting that challenge is going to take cultural savvy, flexibility and above all stamina.

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When Exaggeration Increases Compliance Risk – The Lessons of UHC and Inflated Risk Scores
Janice G. Jacobs, CPA, CPC, CCS, CPCO, ROCC, Managing Director, Berkeley Research Group

Fraudulently exaggerating diagnosis coding is definitely on the government’s radar. This article explores the compliance risks associated with exaggerating diagnosis codes and ways to mitigate potential liability.

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The 21st Century Cures Act Moves One Step Closer to Reality with FDA’s Work Plan
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

With the formal legislative passage of the 21st Century Cures Act (“Act”), a bipartisan effort to expedite research and development and approval of new drugs, the U.S. Food and Drug Administration (“FDA”) is now moving full-steam ahead by making public its legislative implementation work plan in regard to the Act, including a list of agency policy objectives, list of deliverables, and a detailed summary of budget allocations for such Act. Although the FDA’s implementation efforts in this regard are still emerging, it is clear that the Agency is seeking in every way possible to make the Act a new reality for all stakeholders in the life sciences community.

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The New Westward Expansion – Big Pharma Partners with Native Americans to Protect Patents
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

As each pharmaceutical asset becomes more expensive to bring to market, patent protection and patent extension are critical to a drug company’s sustainability. Now, it seems that one drug maker (Allergan PLC) may have found a way to capitalize on the often-forgotten fact of Native American tribal sovereignty to thwart off intellectual property challenges and create additional barriers to market entry. Regardless of whether the strategy is successful, it will bring renewed interest in finding ways to work with tribal interests and one more legal area that compliance officers may need to have a working knowledge about.

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Mylan’s “Banquet of Consequences” Ends for Now with the Latest EpiPen Settlement
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

Mylan has been the subject of bad press for roughly a year now. Fortunately, it seems as though the firestorm surrounding the company – including the EpiPen price saga – may be over for now. This article outlines a recent suit filed by a Mylan competitor and the settlement and CIA that resulted. It concludes with insight from a prominent CEO about how compliance officers and other executives can avoid the negative press Mylan has endured.

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Even Distributors Are Not Immune – AmeriSourceBergen’s Recent Compliance Struggles
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In recent months, AmeriSourceBergen’s (“ABC”) ongoing struggles with compliance about its corporate subsidiaries and wholesale units has been well-publicized. For instance, on August 23, 2017, the United States Department of Justice (“DOJ”) announced a settlement $13.4 Million involving illicit False Claims Act (“FCA”) and kickback billing activities by U.S. Bioservices Corp., a unit of wholesale ABC concerning the medication Exjade. In a separate matter, the DOJ a settlement with ABC to resolve criminal liability relating to illicit business activities by AmeriSouceBergen Specialty Group (“ABSG”), a subsidiary of ABC involving the misbranding and distribution of oncology cancer related medications from a processing facility that was not approved by the U.S. Federal Food and Drug Administration (“FDA”). Both cases highlight the FCA civil, and criminal liability parent companies face for the illicit conduct of their various corporate subsidiaries and entities.

November

2017

November 2017: Life Science Compliance Update

Written by , Posted in November 2017 LSC Update, This Month in Compliance

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November 2017 LSCU Cover

Issue Summary

This month, Life Science Compliance Update has a SPECIAL ISSUE devoted to FOCUS ON THE PATIENT. To open the issue, we explore the critical issue of ACCESS TO MEDICINE and the growing impact of CORRUPTION and what the pharmaceutical industry can do to the help. Continuing the theme of access, we examine the changing environment around EXPANDED PATIENT ACCESS to INVESTIGATIONAL MEDICINES and the balancing act this causes for life science companies.

Next, we continue our series EXPANDING THE FRONTIER examining how companies should consider working with PATIENT ADVOCACY GROUPS and the impact of the latest ENFORCEMENT decisions in the AEGERION cases. Finally, we round out this issue with a look at the latest TRANSPARENCY developments including new OPEN PAYMENTS data, new initiatives in SOUTH KOREA and CANADA, and finally the latest STATE and LOCAL government efforts to expand transparency requirements.


Special Issue: Focus on the Patient

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Why it matters – Pharmaceutical compliance, Anti-corruption and Access to Medicine
Luca Genovese and Danny Edwards, The Access to Medicine Foundation

Access to medicine continues to be out of reach for an estimated two billion people worldwide. While it is clear that corruption plays a role in that problem, the true scope and cost of global health corruption is unknown. This article examines what pharmaceutical companies do and what role they should play in eliminating corruption as part of the equation of ensuring access.

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Increasing the Tension – Expanding Patient Access to Investigational Medical Products
Maureen Lloyd a Health Industries, Risk and Regulatory Director and Dixil Francis a Health Industries, Risk and Regulatory Manager at PWC

Expanding patient access to therapies currently being tested but not yet marketed is both increasingly challenging and important. However, despite the many challenges, changing regulations and industry association guidelines have increased pressure on manufacturers to develop or expand their access to medicines programs. Therefore, it is clear that improving appropriate patient access to investigational medical products remains a prominent objective for the life science industry. This article explores the changing environment surrounding expanded patient access and the practical implications facing life science companies trying to balance competing concerns.

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The Expanding Frontier Part 2 – Navigating the Complexity of Patient Advocacy Groups
Chad A. Morin, Senior Director Healthcare Compliance, bluebird bio

Although many Patient Advocacy Groups have been around for more than 20 years, it has only been in the past couple years that they have had a substantial impact. It is clear that engaging with and assisting PAGs can provide a shared-value to patients. However, doing so is not a simple matter, and this article explores some of the many factors that companies should consider.

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The Expanding Frontier Part 3 – PAGs in Light of the Aegerion Cases
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

There is no doubt that Patient Advocacy Groups play an important and substantial role in shaping the healthcare landscape. It also is true that it is not a simple matter for life sciences companies to work with these groups. This article examines the recent trio of cases involving Aegerion to ascertain what it says about the government’s enforcement stance and how that it may shape the future of industry/PAG interactions.

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Transparency Perhaps a Falling Star in the U.S. But Rising Internationally
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

While interest in transparency seems to be waning in the U.S., it continues to rise internationally with Canada and South Korea. This article will examine the latest numbers from U.S. Open Payments and the efforts of Canada and South Korea.


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Coming Soon to a State or Even City Near You – Part 2 Spend Disclosure & Much More
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

In 2017, the pharmaceutical industry has been hit hard by the increasing number jurisdictions proposing, passing, and implementing numerous compliance requirements ranging from annually reporting payments and other transfers of a value provided to health care professionals, listing or licensing sales representatives and other employees, being prohibited from offering certain discounts, and facing “gift” limitations and restrictions. These jurisdictions include the City of Chicago (representative licensure and disclosure), Nevada (representative listing and disclosure), California (discount prohibition), Maine (“gift” limitations and restrictions), and New Jersey (proposed regulation to limit and cap meals and restrict consulting agreements). With another major election year ahead of the industry, the pharmaceutical industry will be an easy target. In fact, states will use the success of the previous year, combined with the pricing debate and the opioid crisis, to push through legislation and regulations.

October

2017

October 2017: Life Science Compliance Update

Written by , Posted in October 2017 LSC Update, This Month in Compliance

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November 2017 LSCU Cover

Issue Summary

Our feature article this month is a review of the FDA’s recent guidance on OFF-LABEL communications. We also begin a two-part series on STATE and LOCAL activities to regulate the pharmaceutical industry starting with a look at PRICING TRANSPARENCY initiatives. Commercial interactions with PATIENTS and PATIENT ADVOCACY groups is next followed by the latest developments with Ohio’sDRUG SAMPLE VERIFICATION rules. We round out the month with the latest on ENFORCEMENT and WHISTLEBLOWERS.


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The Never-Ending Saga of Off-label Promotion
Jenny McVey, Associate Director, FRA Life Sciences

The concern of misbranded products leading to patient harm and potential fraud is inarguable. The FDA has held a long-standing position on off-label communication; however, in light of recent federal lawsuits that have increased the uncertainty of its enforceability, as well as the growing need for data-driven medicine, the agency has been under pressure more than ever to update their regulatory position. This article will outline industry’s response and the long-awaited guidance from the FDA around off-label communication.

Issue Articles

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Coming Soon to a State or Even City Near You – Part 1 Pricing Transparency
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

As opposition to and concern about the activities of drug manufacturers continue to mount, increasingly states, and even cities, are stepping in to regulate pharmaceutical companies. This is the first in a two-part series focusing on the notable proposed state and city actions and laws and ordinances that have been or soon will be enacted in 2017. The article will focus on drug pricing transparency disclosure legislation that is being introduced at an ever-increasing rate. The pharmaceutical industry cannot fight each and every state and city action successfully. The truth of the matter is that the industry is losing ground and leadership within companies cannot begin to sacrifice their compliance and legal departments.

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The Expanding Frontier – Commercial Interactions with Patients and Patient Organizations
David Davidovic, Founder, pathForward; former Global VP, Commercial Services, Genentech and Roche

Over the past two decades, the role that patients play in their health care has dramatically shifted. As a result, there is an increasing need and drive by life science companies to engage with patients (e.g., patient centricity). However, this approach is not without risk as this article will explore.

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UPDATE: Round 2 with Ohio’s Drug Sample Verification Requirements
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC, Bryan Andrews, Director of Sales Operations, MedPro Systems LLC

In the September issue of the Life Science Compliance Update, the authors discussed the new Ohio drug distribution verification requirements that impact non-controlled prescription drug sampling. This article provides an update with new information from the Ohio State Board of Pharmacy, as well as a one-page “cheat sheet” of those requirements.

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Getting Serious About Fraud – The DOJ Charges 412
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

With the new administration, there appears to be a renewed commitment to enforcing anti-kickback rules against healthcare providers committing fraud against the government insurance programs. In July 2017, the Department of Justice and Department of Health and Human Services announced the largest-ever fraud takedown in the health care arena. This article outlines the announcement, and what it may mean for the future of health care.

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Will Your Whistle Be Heard at Home?
Sally Foroughi, Staff Writer, Life Science Compliance Update

The distinct split between the Second and Fifth Circuit Courts’ interpretation as to when whistleblower protections are allowed has now summoned the attention of the U.S. Supreme Court. Despite clarifications issued in 2015 by the SEC to shed more clarity on Dodd Frank’s anti-retaliation protection to whistleblowers who reported alleged misconduct either internally to company officials or externally to government regulatory bodies, the U.S. Supreme Court will take the case of Digital Realty Trust v. Somer in the Fall of 2017, and finally render a final verdict for when whistleblower protection becomes enforceable. During the interim, it becomes vital for Compliance Officers to have appropriate policies and procedures in place to guide employees in reporting potential misconduct and/or fraud, and to establish a tone of non-retaliation for such reporting, in order to safeguard the best interests of the public and shareholders of the company.

September

2017

September 2017: Life Science Compliance Update

Written by , Posted in September 2017 LSC Update, This Month in Compliance

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July 2017 LSCU Cover

Issue Summary

This month we feature an extensive, in-depth look into the drug distribution verification law in Ohio, which will significantly impact product sampling in the state. We also take a look a mid-year look at False Claims Act settlement and the recent data from U.S. DOJ’s FCPA Pilot Program. Rounding out the issue are a look at two recent FCA cases involving Fresenius and Celgene, both of which have the promise to impact how FCA cases are pursued in the future.


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Ohio Drug Distribution Verification: America’s Key Battleground State Shakes Up the Pharmaceutical Supply Chain
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC; John Patrick Oroho, Esq., Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman PC; Teresita Weiss, Ph.D., J.D., Sr. Vice President, Regulatory Affairs and Compliance, for J. Knipper and Company, Inc.; Bryan Andrews, Director of Sales Operations, MedPro Systems LLC.
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Issue Articles

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False Claims Act Mid-Year Review: Significant Life Science Settlements, Post-Escobar Developments & Industry Round Up
John Kelly, Julia Tamulis, and Robert Platt
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To Disclose or Not to Disclose…. That is the Question: The DOJ’s FCPA Pilot Program – Insights from Year One and Beyond
Mark Scallon, Partner, FRA Life Sciences, Jenny McVey, Manager, FRA Life Sciences and Jimmy Ko, Senior Associate, Forensic Risk Alliance
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Fresenius to the U.S. Government: When It Comes to the FCA, You Snooze You Lose
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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Taking Center Stage – Washington State’s Medicaid Fraud Control Unit, the False Claims Act and Celegene
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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August

2017

August 2017: Life Science Compliance Update

Written by , Posted in August 2017 LSC Update, This Month in Compliance

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August 2017 LSCU Cover

Issue Summary

Welcome to the Dog Days of Summer! This month we focus once more on off-label promotion, with a special three-part series. We also take a look at recent developments involving the Escobar case and the latest from the U.S. Supreme Court on products liability/mass tort jurisdiction. Finally, we have an article from Matt Kelly on the Fine Art of Policy Management.


LSCU Special Feature

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A Murky Future for Off-label Promotion

Within the world of life science product regulation, the area of off-label promotion is perhaps the most complicated, emotional and uncertain of all. It is an ever-changing landscape of regulations, court decisions and now politics. It is a landscape that the LSCU has covered in many issues, and once more it is making headlines. This three-part series will explore the impact that the new FDA Commissioner will have on the debate, how Congressional efforts could make things even more complicated for life science compliance professionals, and the latest efforts by Arizona to allow off-label promotion. – Dr. Seth Whitelaw, Editor

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PART 1: New Leadership at the FDA Brings Change
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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PART 2: Off-Label Bills Garner Minimal Traction in Congress
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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PART 3: States vs. FDA – Arizona to Allow Pharma Companies to Legally Communicate Off-Label Treatment Options
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Other Issue Articles

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A New Application of Escobar: Gilead or When Half-Truths Can Become Actionable Under the FCA
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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Independent Review Organizations (“IRO”) and Conflicts of Interest – Much Ado About Nothing or a Serious Problem
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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The Fine Art of Policy Management
Matt Kelly, Editor & CEO at Radical Compliance
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This Isn’t Walmart: The Supreme Court Narrows Forum-Shopping Options
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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July

2017

July 2017: Life Science Compliance Update

Written by , Posted in July 2017 LSC Update, This Month in Compliance

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July 2017 LSCU Cover

Issue Summary

For the July issue, we have focused compliance program effectiveness. Our feature this month explores compliance resourcing challenges for small to mid-sized pharmaceutical companies. We follow this up with a detailed review of the new DOJ and OIG guidance documents. We also take a hard look at project pricing and how the current legal and regulatory structure may impinge on efforts to reduce costs. Finally, we take a look at the latest developments in transparency and false claims enforcement.


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This is Not Your Parent’s Compliance Program – The New Era of Compliance Resourcing at Small to Mid-Size Pharmaceutical Companies
Patrik Florencio, Esq., Steven Franchetti, Seth Whitelaw, J.D., LL.M., S.J.D.
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Issue Articles

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Effectiveness, The Holy Grail of Compliance – Both the DOJ & OIG Weigh In
Sally Foroughi, Staff Writer, Life Science Compliance Update and Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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The California Hurdle – SB 790 and Pharma
Jenny McVey, Life Sciences Manager, FRA
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LSCU SPECIAL FEATURE: Into the Nexus – Anti-Kickback Statute (“AKS”) versus Value-Driven Health Care
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Pharmaceutical and Device Manufacturers: Buyer Seller Beware
John Kelly, Matt Curley and Rob Platt
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Punting on the Issue of FCA and Statistical Sampling
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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June

2017

June 2017: Life Science Compliance Update

Written by , Posted in June 2017 LSC Update, This Month in Compliance

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June 2017 LSCU Cover

Issue Summary

This month we focus on the very real compliance issue of connecting with patients. First, Nico Fiorentino explores the history and latest case involving the use of clinical educators. Then we take another look at the issue of patient assistance programs and the most recent batch of subpoenas. Next Jenny McVey and Mark Scallon explore the General Data Protection Regulation which is set to have substantial impact on the life sciences industry. Finally, we look at the latest developments in transparency, false claims act cases and the 21st Century Cures Act.


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White Coat” Marketing Gone Awry
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC
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Issue Articles

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The Battle Over Patient Assistance Programs Heats Up
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Europe Moves to the Next Level in Protecting Personal Data – The GDPR & Research
Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA
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Chicago’s Attempt to Regulate Drug Reps – A Real Public Health Initiative or Simple Revenue Generator?
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance UpdateTM by NXLevel Solutions
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Genentech & Escobar: Using Materiality to Escape False Claims Liability
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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An FCA Journey – Allergan to Pay $53M to DOJ
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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The 21st Century Cures Act: Is It Worth the Cost for Lifesciences?
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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May

2017

May 2017: Life Science Compliance Update

Written by , Posted in May 2017 LSC Update, This Month in Compliance

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May 2017 LSCU Cover

Issue Summary

This month we go in-depth into the world of pricing. Our feature article by Nico Fiorentino reviews the new state legislation that has cropped up to deal with prescription drug pricing. We also have a second installment on the 340B program from Clay Willis and Chris Cobourn. This month they discuss the danger of duplicate discounts and diversion. On the global stage, Jenny McVey and Mark Scallon review the changes coming for medical devices in Europe under the MedTech Code. Finally, in addition to the enforcement developments, Lauren Barnett and Sean Murphy highlight ways the compliance training curriculum can help reduce risks.


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Whack a Mole – Pricing Bills Keep Popping Up Everywhere
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC
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Global Issues

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Changing the Rules Again: The MedTech Europe Code & Third-Party Educational Support
Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA
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The Financial Risk of Waiting – 340B, Duplicate Discounts and Diversion
Clay Willis, Life Science Director and Chris Cobourn, Managing Director, Huron Life Sciences
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Improving Outcomes – Analyzing a Compliance Training Curriculum to Reduce Risk
Lauren Barnett, Senior Compliance Content Specialist and Sean Murphy, Product and Marketing Manager, PharmaCertifyTM by NXLevel Solutions
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A Port in Any Storm – Adding New Safe Harbors to the Anti-Kickback Statute
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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