2016 LSHI Events Catalog - Reed Smith...2016 Reed Smith and BRG Washington Health Care Conference “How Current Trends Impact the Future of Life Sciences and Health Care” May 19,

Spring – Fall 2016

2016 LSHI Events Catalog

Life Sciences Health Industry Group

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For further information on our upcoming programs, to register, or to propose topics, please contact [email protected]

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DRI Drug and Medical Device ConferenceMay 19 – 20, 2016Chicago Marriott Downtown | ChicagoConference

Reed Smith is proud to co-sponsor this year’s DRI Drug and Medical Device Conference, “For the Defense: Litigation Across the Drug and Device Spectrum.” Reed Smith counsel Lisa M. Baird will be presenting on “Free Speech: Amarin and First Amendment Challenges” on May 19 at 11:10 a.m., and Reed Smith associate Jennifer A. Eppensteiner will be presenting on “Guess Who’s Coming to Trial: Identifying the Representative Plaintiff for MDL Bellwether Selection” on May 19 at 1:40 p.m. as part of the Young Lawyers Blockbuster. Reed Smith will sponsor the event’s Continental breakfast on May 20 at 7 a.m.

3D Printing and Intellectual Property April 27, 2016 | 12-1 p.m. ETTracy Quinn and Matt ShielsWebinar

3D printing technology is poised to revolutionize and democratize manufacturing. This program will examine 3D printing’s potential impact on Intellectual Property rights as the technology becomes faster, cheaper, and more widespread. The program will begin by highlighting the various types of intellectual property rights implicated by 3D printing. It will also explore how enforcement strategies will be affected by the distributed nature of 3D printing. Finally, the program will examine various strategies that rights-holders might employ to tackle the unique challenges and opportunities presented by this disruptive technology.

Approved for 1 hour of general CLE credit.

Telehealth Policy Update: Keep Calm, Changes Are Coming June 8, 2016 | 1-2 p.m. ETPaul Pitts and Trey AndrewsWebinar

This program will describe recently adopted and proposed changes to state and federal laws impacting telehealth. We will touch on some of the regulatory obstacles restraining the use of telehealth and what policy changes we anticipate in the short term. Specific topics will include:

• State efforts to change coverage and reimbursement policy• Medicare policy discussions• The current federal/state regulatory and licensing environment, and the challenges and proposals of allowing

Medicare providers to offer telehealth services across state lines

• Regulation of internet prescribing• Status of Teladoc, Inc., et al. v. Texas Medical Board, et al.

Preemptively approved for 1 hour of general CLE credit.

Medicaid Drug Rebate Program – A 25-Year Anniversary and Look-Ahead Sponsored by Reed Smith and KPMG May 4, 2016 | 8 a.m. -12 p.m. ET KPMG Offices | Washington, D.C.Seminar

To commemorate the 25th anniversary of the Medicaid Drug Rebate Program, KPMG LLP (KPMG) and Reed Smith LLP (Reed Smith) are hosting a half-day conference to focus on significant milestones, challenges and possible opportunities for the future of the Medicaid Rebate Program.

The mini conference will feature a keynote address and discussion with Dr. John Coster, Director, Division of Pharmacy – Disabled and Elderly Health Programs Group, Centers for Medicare and Medicaid Services (CMS). As a Senate staffer, Dr. Coster led development of the rebate program legislation (OBRA ’90) and now has oversight and operations responsibility for the Medicaid Rebate Program at CMS. The keynote and discussion will be followed by short expert reactor panel discussions.

2016 Reed Smith and BRG Washington Health Care Conference “How Current Trends Impact the Future of Life Sciences and Health Care”May 19, 2016 | 8:30 a.m. – 2 p.m. ETThe Mayflower Hotel | Washington, D.C.Conference

Please join Reed Smith and the Berkeley Research Group (BRG) for a thought-provoking, half-day seminar on transactional, regulatory and litigation hot topics impacting the industry landscape for pharmaceutical and medical device manufacturers and health care providers. Leading industry professionals will be highlighting the current trends and future implications related to:

• Private Equity Market Landscape• Data Mining in FCA Litigation: What Providers Need to Know• The Problem of Compliance Sustainability in Pharmaceutical Drug Pricing• Strategies for Challenging Government Statistical Sampling & Extrapolation• 3D Printing: How the Technology Is Revolutionizing Health Care• Keynote: Election Analysis and Insights – Sean Trende, Senior Elections Analyst, RealClearPolitics

Preemptively approved for 2.5 hours of CLE credit.

Smart Strategies: What You Need to Know About CJR and Other Bundled Payment Programs May 4, 2016 | 12-1 p.m. ETGail Daubert, Susan Edwards and Scot HasselmanWebinar

On November 24, 2015, the Centers for Medicare & Medicaid Services (CMS) published a significant final rule that requires hospitals in selected geographic areas to participate in a new Medicare Comprehensive Care for Joint Replacement (CJR) model as of April 1, 2016.

This webinar will review the CJR Final Rule, explaining its impact on a variety of providers and suppliers, including hospitals, physicians, post-acute providers, and medical device manufacturers. Not only will the webinar provide an overview of how the CJR program works, but the Reed Smith presenters will also discuss general trends in the shift to alternative payment models, including bundling.

Approved for 1 hour of general CLE credit.

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Medicare Secondary Payer: Issues and Best Practices for the Defense July 13, 2016 | 12-1 p.m. ETEric Gladbach and Mildred SeguraWebinar

Medicare Secondary Payer liability places a range of burdens on pharmaceutical, medical device and other defendants following a plaintiff’s verdict or settlement. Not only can companies find themselves on the line to pay a second round of damages – this time to CMS – if the plaintiffs fail to reimburse Medicare, but defendants are also responsible for costly, time-consuming reporting to the government.

This webinar provides an overview and timeline of reporting responsibilities; discusses best practices in discovery demands, release language, check issuance, and requesting payment/no payment letters from Medicare; examines the Global Resolution Option alternative; and highlights other issues corporate defendants may face, such as future costs and set-asides. Preemptively approved for 1 hour of general CLE credit.

Where Was This Made? Country-of-Origin Issues for Pharmaceutical & Medical Device CompaniesJuly 19, 2016 | 12-1 p.m. ETJeffrey Orenstein and Lawrence SherWebinar

Drug and device manufacturers often struggle to correctly determine their products’ “country of origin,” thanks to ever-changing global supply chains and the fact that different government agencies employ entirely different legal standards. As a result, a product’s country of origin may vary based on which agency is requiring a determination. This has caused considerable confusion and, yet, compliance has never been more important as multimillion-dollar False Claims Act actions become more frequent for companies that incorrectly certify the origin of their products to the government.

This webinar examines the numerous regulatory requirements that companies must take into consideration to ensure compliance over time. It also explains the risks of non-compliance in the context of both administrative penalties and False Claims Act actions initiated by the government and whistleblowers. Preemptively approved for 1 hour of general CLE credit.U.S./Ex-U.S. Privacy Issues

June 20, 2016 | 12-1 p.m. ETBrad Rostolsky, Daniel Kadar and Cynthia O’DonoghueWebinar

Privacy and security issues continue to be critically important in both the United States and the European Union, and many global life sciences and health care companies are increasingly keeping their eye on data protection and cybersecurity obligations on both sides of the Atlantic, particularly in light of recent and proposed regulatory changes. This webinar will focus on the changes and uncertainties regarding:

• EU-U.S. Privacy Shield • New data protection regulation• New cybersecurity directives• Changes in document regulation• HIPAA enforcement and OCR agenda update


Personal Jurisdiction: What Bauman Does and Doesn’t Mean, the Other Side’s Response, and Why Corporations Should Care June 14, 2016 | 12-1 p.m. ETJames Beck and Stephen McConnellWebinar

The U.S. Supreme Court’s 2014 decision in Daimler v. Bauman represents a sea-change in corporate personal jurisdiction. “General” personal jurisdiction is no longer anywhere a corporation conducts “continuous and substantial” business, but only where it is “at home” – essentially place of incorporation and principal place of business. Plaintiffs’ lawyers are revising their strategies, looking for ways around Bauman that keep cases in their favorite forums, such as “consent” and “pendent jurisdiction.” To take full advantage of Bauman, defendants have to keep up. This webinar will examine recent personal jurisdiction rulings and discuss what corporations can learn from them.


ThinkDifferently.3DPrinting–WillRegulatoryPathwaysand Reimbursement Change?July 21, 2016 | 12-1 p.m. ETGail Daubert, Kevin Madagan and Celeste LetourneauWebinar

The increasing popularity of 3D printing is changing the future of health care far more dramatically than we would have ever imagined. Currently, the FDA has approved one 3D printed drug, and cleared no fewer than 85 medical devices through the 510(k) process. As these products make their way to the market, manufacturers and providers are faced with another big hurdle – how to get reimbursed. This webinar will address current FDA regulatory pathways and explore the many unanswered questions surrounding 3D printing reimbursement issues for providers and manufacturers, including:

• How will providers/manufacturers be compensated, and how will it be determined?• Will there be coverage?• What are the current codes, and will new codes have to be written?• What is the future for health care, medical devices and drugs in relation to 3D printing?


3D Printing and Environmental Safety August 24, 2016 | 1-2 p.m. ETTodd Maiden and Farah TabibkhoeiWebinar

3D printing provides significant environmental benefits over traditional manufacturing techniques. However, this disruptive technology also presents environmental and health hazards. This program will examine the toxic effects of 3D printing, potential liability, and how to reduce exposure to these risks. The program will also explore global and local environmental safety regulations affecting 3D printing, as well as strategies for regulatory compliance for 3D printing businesses and manufacturers.




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Medicare Overpayment Rule October 19, 2016 | 12-1 p.m. ETScot Hasselman and Nan HalsteadWebinar

On February 12, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register its final overpayment refund rule. The final rule implements a mandate of the Affordable Care Act (ACA) requiring providers and suppliers to report and return Medicare overpayments by no later than 60 days after the date on which the overpayment was “identified.” This webinar will discuss the statutory requirements of overpayments under the ACA, followed by specific enforcement examples. We will pay particular attention to how government audits/ reports may serve as “credible information,” and the role statistical sampling/extrapolation will play in meeting a provider’s “reasonable diligence” obligation.


3D Printing Series – Tort Liability October 6, 2016 | 12-1 p.m. ETJames Beck, Colleen Davies, Matt Jacobson and Farah TabibkhoeiWebinar

3D printing is a disruptive, innovative technology that will revolutionize manufacturing, in part by allowing non-traditional entities – including consumers themselves – to engage in product manufacturing. This program will examine 3D printing’s potential impact on product liability laws as the technology becomes faster, cheaper, and more widespread. Traditional product liability theories, based on “manufacturer” liability, will be under scrutiny as entities not usually considered manufacturers begin to produce 3D printed objects. We will discuss and evaluate possible alternative theories that plaintiffs may advance when someone is injured as a result of a design or manufacturing defect in a 3D printed product. Particular attention will be given to the impact of 3D printing on FDA-regulated prescription medical products. Finally, the program will examine various strategies that companies or potential product liability defendants – traditional and non-traditional – might use, prior to litigation, to minimize their possible exposure and mitigate the risk of liability.


HIPAA Compliance Updates – What You Need to Know September 21, 2016 | 12-1 p.m. ETBrad Rostolsky and Nan HalsteadWebinar

This webinar will focus on general updates regarding HIPAA compliance for covered entities (particularly, health care providers) and business associates. In particular, we will address the significant increase in enforcement actions this year, highlighting the compliance areas associated with recent enforcement, as well as the following topics:

• The revised audit protocol• New guidance from the Office of Civil Rights (OCR)• Expected rulemakings from OCR in the next year• The role other agencies may play in enforcing HIPAA


Out-of-Network Payment Disputes September 14, 2016 | 12-1 p.m. ETLorin Patterson, Sal Rotella and Nicole AikenWebinar

The co-payments, deductibles and coinsurance that providers collect from members of out-of-network plans, and what those plans must pay the providers, is a hotly contested and rapidly evolving area of health law. This webinar will review state laws and pending litigation addressing the extent to which providers can waive or discount these cost-share amounts for out-of-network patients, and how plans are responding when this happens. We will also address network contracting and other issues that arise when providers and payors seek to resolve disputes over patient cost-share amounts.


Social Media Issues for Pharmaceutical and Medical Device CompaniesNovember 2, 2016 | 12-1 p.m. ETCeleste Letourneau, Kimberly Chow and Jennifer PikeWebinar

Social media can be a great way to engage with consumers and build your brand. For pharmaceutical and medical device companies, however, it can also open up a Pandora’s Box of regulatory issues – and potentially help plaintiffs’ lawyers in claims that a company was over-extolling the efficacy and safety of its products. This webinar looks at how drug and device companies can use regulatory agencies’ guidance to avoid these pitfalls – and offers best practices you can use where guidance is lacking.


Overcoming the Hurdles of Health Care TransactionsNovember 16, 2016 | 12-1 p.m. ETCarol Loepere and Karl ThallnerWebinar

The health care industry continues to be among the hottest sectors for mergers, acquisitions, joint ventures and other transactions. Health reform, new payment models, and reimbursement pressures are driving vertical integration among providers (in some cases with insurers) aimed at providing better care more efficiently, and horizontal integration that leads to economies of scale and capitalizes on industry experience. Yet, the challenges of these deals can be significant. Obtaining licensing approvals, certificates of need and state attorney general sign-off can be daunting. This program will identify key regulatory hurdles that arise in health care transactions, will suggest due diligence approaches, and discuss deal structuring approaches and emerging trends.




ABU DHABI

ATHENS

BEIJING

CENTURY CITY

CHICAGO

DUBAI

FRANKFURT

HONG KONG

HOUSTON

KAZAKHSTAN

LONDON

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MUNICH

NEW YORK

PARIS

PHILADELPHIA

PITTSBURGH

PRINCETON

RICHMOND

SAN FRANCISCO

SHANGHAI

SILICON VALLEY

SINGAPORE

TYSONS

WASHINGTON, D.C.

WILMINGTON

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Reed Smith LLP is associated with Reed Smith LLP of Delaware, USA and the offices listed herein are offices of either Reed Smith LLP or Reed Smith LLP

of Delaware, USA, with exception of Hong Kong, which trades as Reed Smith Richards Butler.

Philadelphia Life Sciences CLE Day November 10, 2016 | 9:00 a.m. – 1:30 p.m. ETSeminar

Reed Smith’s Life Sciences Health Industry Group is pleased to offer a half-day CLE covering hot topics and emerging litigation trends for in-house counsel.

CLE Credit Pending.

Documents

2016 LSHI Events Catalog - Reed Smith...2016 Reed Smith and BRG Washington Health Care Conference “How Current Trends Impact the Future of Life Sciences and Health Care” May 19,