Life Science Compliance Update

May

2018

May 2018: Life Science Compliance Update

Written by , Posted in Home page, 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the FDA, we have two articles covering the new guidance on HEALTH INFORMATION collected by MEDICAL DEVICES and the new DRAFT GUIDANCE for COMPOUNDING PHARMACIES.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.

May

2018

Update – Allergan’s Patent Transfer To Native Americans Lacks Merit

Written by , Posted in Uncategorized

Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

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.


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May

2018

The Wheels of Time Grind Slowly – FDA Issues Draft Guidance For Compound Pharmacy Outsourcing Facilities

Written by , Posted in Uncategorized

Carolyn Greene

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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Topic tags:

May

2018

The Intersection Between Patients, Health Information And Devices – New FDA Guidance Attempts To Prevent A Traffic Accident

Written by , Posted in Uncategorized

Gwendolyn Ball, Staff Writer, Life Science Compliance Update

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.


   or   


May

2018

Open Payments & Kickbacks: Are Indicted Physicians on Your Company’s Payroll?

Written by , Posted in Uncategorized

Nicodemo Fiorentino, Esq.

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.


   or   


May

2018

Not Your Average OIG Presentation – Greg Demske Defines A “Successful” OIG Based On Fairness, Communication, And Compliance At The Mitchell Hamline Symposium

Written by , Posted in Uncategorized

Gwendolyn Ball, Staff Writer, Life Science Compliance Update

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.


   or   

Topic tags:

May

2018

It’s Not Just Money – Theranos & SEC Come to Terms

Written by , Posted in Uncategorized

Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

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.


   or   

Topic tags:

May

2018

April

2018

April 2018: Life Science Compliance Update

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

The full text of the entire issue is now available to our subscribers. If you are a subscriber please log in now. You may also buy this issue by clicking on the button below.


   or   

April 2018 Issue Free Article

Click here to view this article for free.

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Data Analytics & Detecting Medicare Fraud – A Promising Idea Still Awaiting Proof of Concept
By Gwendolyn Ball
Tags: , ,
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.

April

2018

The End of Guidance Documents or Simply a Reminder of Well-Established Administrative Law Principles

Written by , Posted in Uncategorized

Kaitlin Fallon Wildoner, Esq., and Seth B. Whitelaw, J.D., LL.M, S.J.D.

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.


   or   


April

2018

The War on Patient Assistance Programs Takes a New Twist – The Tortured History of Caring Voice Coalition

Written by , Posted in Uncategorized

Kaitlin Fallon Wildoner, Esq., and Seth B. Whitelaw, J.D., LL.M, S.J.D.

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.


   or   


April

2018

The Escobar Hurdle – False Claims, Materiality, and Dismissal

Written by , Posted in Uncategorized

Robert N. Wilkey, Esq.

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.


   or   

Topic tags:

April

2018

It’s Not All About the Money – Medtronic’s Infusion Multi-State Settlement Agreement

Written by , Posted in Uncategorized

Robert N. Wilkey, Esq.

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.


   or   


April

2018

Data Analytics & Detecting Medicare Fraud – A Promising Idea Still Awaiting Proof of Concept

Written by , Posted in Uncategorized

Gwendolyn Ball

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.


   or   

Topic tags:

April

2018

Coming into the Modern Era – CMS Creates Interagency Task Force to Examine Alternative Payment Mechanisms

Written by , Posted in Uncategorized

Gwendolyn Ball

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.


   or   


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