Publications of Interest > FDA & Healthcare > Practices : Morgan, Lewis & Bockius

05/22/12 Manufacturer Patient Support Initiatives: Current Practices and Recent Challenges, presented at the AHLA/FDLI's Intersecting Worlds of Drug, Device, Biologics and Health Law

Presentation | Speech
Andrew Ruskin

Morgan Lewis partner Andrew Ruskin presented on "Manufacturer Patient Support Initiatives: Current Practices and Recent Challenges" at AHLA/FDLI's Intersecting Worlds of Drug, Device, Biologics and Health Law. more

05/03/12 HHS Plugs Payment Suspensions as Key Tool in Latest Takedown

LawFlash/Client Alert | Life Sciences & Healthcare LawFlash
Kathleen McDermott, Arianne Callender, Howard Young, Eric Sitarchuk

The Medicare Fraud Strike Force's use of a pivotal ACA regulation to suspend payments during criminal investigations signals a turning point in its prosecution strategy.

05/02/12 Update on the Biosimilars Competition and Innovation Act: Overview and Life Cycle Planning for Biosimilars, presented at the BioNJ Diamond Circle Board of Trustees Meeting

Presentation | Stephen Mahinka, Kathleen Sanzo

04/30/12 Preparing for the U.S. Supreme Court’s Healthcare Decision

LawFlash/Client Alert | Employee Benefits LawFlash
Andy Anderson

By taking a number of interim steps, employer group health plans can position themselves to respond quickly and appropriately—whether healthcare reform is upheld, partially upheld, or struck down.

04/18/12 Manufacturers Affected by Recent Medicare Part D Rule

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Andrew Ruskin, Donna Lee Yesner

CMS formalizes its Medicare Part D Coverage Gap Discount Program rules as part of an omnibus Medicare Part C and Part D rulemaking.

04/10/12 FDA Issued ACA Industry Submission Specifications User Guide for ACA §6004

Marketing Material | Supplemental Info

04/10/12 Health Industry Compliance Brochure

Marketing Material | Brochure

04/09/12 Recent Letter to CMS from Kohl and Grassley on Finalizing Sunshine Regs by June 2012

Marketing Material | Supplemental Info

04/04/12 Healthcare Tops the Agenda of U.S. Antitrust Enforcers

LawFlash/Client Alert | Antitrust LawFlash
R. Brendan Fee, Sarah Rabinovici, Jonathan Rich

Agencies promise close scrutiny of hospital mergers, reverse payment settlements, and REMS abuses.

04/02/12 It’s Not Just Pill Mills The DEA Is After, Law360

Outside Publication | Article
Kathleen Sanzo, Lee Rosebush, Michele Buenafe

03/30/12 The OIG and Hospice in Nursing Facilities: Past, Present and Future, presented at the National Hospice and Palliative Care Organization's (NHPCO) 27th Management and Leadership Conference, National Harbor, MD

Presentation | Speech
Howard Young

03/29/12 HACs, Readmissions and VBP: Hospital Strategies for Turning Lemons into Lemonade, presented at the Institute on Medicare and Medicaid Payment Issues, Baltimore, MD

Presentation | Speech
Andrew Ruskin

03/28/12 First Amendment Off-Label Promotion Cases Work Their Way Through the Courts, Journal of Health Care Compliance

Outside Publication | Article
Jacqueline Berman

Much remains to be seen.

03/28/12 The Proposed Rule on Transparency Reports: Shedding Light on the Sunshine Act, Journal of Health Care Compliance

Outside Publication | Article
Scott Memmott, Jennifer Clarke

An overview of the most important aspects of the proposed regulations.

03/09/12 Pharmacies and Suppliers Beware: It Is Not Just the Pill Mills They Are After

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Lee Rosebush, Michele Buenafe

DEA's recent position against a national pharmacy chain and a wholesale distributor expands the proactive monitoring and auditing requirements for pharmacies and wholesale distributors to include site visits and possibly medical necessity reviews.

February 2012 Co-author, Compliance Certifications and the Era of Accountability—A Forecast to Debate, Journal of Health & Life Sciences Law, Vol. 5, p. 158

Outside Publication | Article
Kathleen McDermott, Arianne Callender

02/09/12 FDA Issues Three Draft Guidances for Biosimilars

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Stephen Mahinka, Phoebe Mounts, Alexis Miller, Kathleen Sanzo

Initial guidance provides insights on regulatory pathway for biosimilars, but does not address many critical issues.

02/06/12 CMS Proposes Major Changes to AMP Rule

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Andrew Ruskin, Donna Lee Yesner, Stephen Ruscus

The Proposed Rule provides provisions that will significantly impact pharmaceutical manufacturers' rebate liability, price reporting calculations, and possibly their operations.

01/26/12 Transparency Compliance Webinar

Presentation | Webinar
Rebecca Osowski, Kathleen McDermott, Jonathan Havens

Morgan Lewis hosted a webinar focusing on the Centers for Medicare and Medicaid Services' (CMS) long-awaited proposed rule, "Transparency Reports and Reporting of Physician Ownership or Investment Interests." This webinar pr... more

01/25/12 2011 American Health Lawyer’s Association Annual Meeting

Presentation | Speech
Kathleen McDermott

Morgan Lewis's Kathleen McDermott presented "The Era of Individual Accountability-Is A Liability Hailstorm On The Way?" at the 2011 American Health Lawyer's Association Annual Meeting. Ms. McDe... more

01/11/12 FDA Gets (Un)Social

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Alexis Miller

FDA draft guidance on responding to requests for off-label information foreshadows restrictive policies on use of social media.

01/04/12 Physician-Vendor Relationships Under Heightened Scrutiny: Avoiding or Minimizing Liability Under False Claims, Stark, and Anti-Kickback Laws (a Strafford webinar)

Presentation | Webinar
Arianne Callender

Federal regulators and prosecutors are aggressively pursuing allegations of improper financial relationships between physicians and vendors. Areas of concern include the use of free samples, "sham" consulting and advisory payment... more

2011 Co-author, Prescription, Drug Promotions and Marketing, FDLI’s Food and Drug Law Regulation 2011, 2nd edition

Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka

12/21/11 CMS Issues Transparency Reporting Proposed Rule

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Rebecca Osowski, Kathleen McDermott, Jonathan Havens, Michele Buenafe

The Centers for Medicare and Medicaid Services' proposed rule, which will implement Section 6002 of the Patient Protection and Affordable Care Act, clarifies several definitions, provides further information on reporting requirements, and offers guidance on submitting required information.

12/05/11 Comparative Effectiveness Research: Impact on Pharmaceutical Pricing and Marketing, presented at the QI Productions Conference on Integrating Comparative Effectiveness Research, Philadelphia

Presentation | Speech
Stephen Mahinka

Topics presented include: Structural Changes in Pharmaceutical Industry Stimulating Focus on Comparative Effectiveness Research Potential Changes by Healthcare Reform Law Affecting Demand Levels and Prices/Payments ... more