Stefanie A. Doebler

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Stefanie A. Doebler

Of Counsel

Washington +1 202 662 5271 sdoebler@cov.com Download V-card

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Stefanie Doebler is of counsel in the firm's health care and food and drug practice groups. Her practice focuses on health care compliance matters for pharmaceutical and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, state law compliance and reporting regulations, interactions with health care professionals, clinical trial conduct and results disclosure, supply chain management, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.

Advice to trade association regarding implementation of the federal Sunshine Act and related advocacy before the Centers for Medicare and Medicaid Services.
Assistance to a pharmaceutical company regarding compliance with a corporate integrity agreement, including developing and implementing a comprehensive compliance program.
Advice on kickback and related issues associated with product support programs for a specialty pharmaceutical product.
Evaluation of the promotional activities of a medical device company to identify high-risk initiatives.
Representation of major pharmaceutical company in criminal investigation under the FDCA.
Internal investigation for a pharmaceutical company regarding its publications policies and practices.

Representation of a local non-profit organization in legislative and regulatory efforts to ensure that the regional affiliate of a national insurance company fulfills its charitable health care obligation to the National Capital Area.
Assistance to dual-eligible individuals regarding their Medicare prescription drug benefits

Special Update: HHS Proposes to Exclude Prescription Drug Rebates to PBMs from Safe Harbor Protection

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a new rule yesterday proposing to revise the Anti-Kickback Statute safe harbor at 42 C.F.R. § 1001.952(h) to explicitly exclude manufacturer rebates and other price reductions on prescription drugs paid to Part D plans, Medicaid managed care organizations (MCOs), or ...

2018 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

This e-alert reviews trends emerging from warning letters and untitled letters concerning therapeutic product advertising and promotion issued in 2018 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality ...

FDA Advertising and Promotion Enforcement Activities Update

This e-alert is part of a series of e-alerts summarizing publicly available U.S. Food and Drug Administration (FDA) enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

Covington Assists Veritas Capital with $5.7 Billion Acquisition of athenahealth

WASHINGTON—Covington is advising private equity firm Veritas Capital on healthcare and other regulatory aspects of its recently announced deal to acquire athenahealth for approximately $5.7 billion. athenahealth is a leading provider of network-enabled services for hospital and ambulatory customers nationwide. Rujul Desai and Ian Brekke are leading the Covington ...

FDA Issues Two Final Guidances on Communications Not Included In Product Labeling

Last month, FDA issued two final guidances on medical product communications, including communications by medical device companies about unapproved uses of approved/cleared medical products: “Medical Product Communications That Are With the FDA-Required Labeling—Questions and Answers” (CWL Guidance) and “Drug and Device Manufacturer Communications With Payors, ...

Oregon HB 4005: New Reporting Requirements for Drug Manufacturers, Health Insurers

On Tuesday, March 13, 2018, Oregon Governor Kate Brown signed into law House Bill 4005 (HB 4005), which imposes substantial new state reporting requirements on pharmaceutical manufacturers regarding drug pricing, including details on manufacturer-sponsored patient assistance programs.

2017 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

This e-alert reviews trends emerging from warning letters and untitled letters concerning therapeutic product advertising and promotion issued in 2017 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation and Research ...

CMS Revises Medicare Part B Biosimilar Coding and Payment Policies

On November 1 and 2, 2017, the Centers for Medicare & Medicaid Services (“CMS”) released two final rules addressing changes to Medicare Part B reimbursement policies for biosimilars. These final rules—for the Medicare Physician Fee Schedule (“PFS”) and the Hospital Outpatient Prospective Payment System (“OPPS”)—announced new directions for both the coding and ...

California SB 17: New Requirements for Drug Manufacturers

On Monday, October 9, 2017, California Governor Jerry Brown signed into law Senate Bill 17 (SB 17), establishing substantial new reporting and notification requirements in California for prescription drug manufacturers related to drug pricing. California is the latest of several states to enact legislation related to drug pricing. This alert, prepared by ...

FDA Advertising and Promotion Enforcement Activities: Update

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics. In May, FDA’s Office of Prescription Drug Promotion (OPDP) posted the following letter on FDA’s website: Untitled ...

Covington Represents India-Based Healthcare Company In Drug Portfolio Acquisition

WASHINGTON—Covington represented India-based Piramal Enterprises and its wholly owned Critical Care subsidiary in the UK in its agreement to acquire a portfolio of intrathecal spasticity and pain management drugs from Mallinckrodt LLC. The purchase price was $171 million, plus an earn-out of up to an additional $32 million. This is the third acquisition that ...

2016 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity

This alert reviews trends emerging from the warning and untitled letters issued in 2016 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER). No warning or untitled letters concerning promotion were issued this year by the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation ...

Covington Announces New Counsel

WASHINGTON, DC — Covington has promoted eight lawyers to of counsel and eight to special counsel, effective April 1, 2016. The new of counsel are as follows: Stefanie Doebler (Washington) focuses her practice on health care compliance matters for pharmaceutical and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, ...

Summary of FDA Advertising and Promotion Enforcement Activity in 2015

This e-alert is part of a series of alerts summarizing publicly-available FDA enforcement letters relating to the advertising and promotion of prescription drugs, medical devices, and biologics. This alert reviews warning and untitled letters issued in 2015. In 2015, FDA’s Office of Prescription Drug Promotion (OPDP) posted the following letters on FDA’s ...

Covington Advises Lombard Medical in U.S. IPO and Re-domicile

LONDON, 1 May, 2014 — Covington & Burling advised Lombard Medical, Inc. on its $55 million U.S. initial public offering and the listing of the company’s ordinary shares on the NASDAQ Global Market. Covington also advised the company on its change of domicile from the U.K. to the Cayman Islands and the delisting of its shares from the AIM market of the London ...

Covington’s Doebler to Receive Klepper Prize for Volunteer Excellence

WASHINGTON, DC, March 4, 2014 —The Legal Aid Society of the District of Columbia has awarded Stefanie Doebler its Klepper Prize for Volunteer Excellence, which recognizes lawyers early in their careers who have made a significant volunteer contribution to the Society. Ms. Doebler, special counsel in Covington & Burling’s health care and food and drug practice ...

Covington Advises Salix in $2.6 Billion Acquisition of Santarus

WASHINGTON, DC, November 7, 2013 — Salix Pharmaceuticals, Ltd., and Santarus, Inc. announced today that the companies have entered into a merger agreement where Salix will acquire all of the outstanding stock of Santarus for $32 in cash per share, for a total value of approximately $2.6 billion. Covington & Burling LLP is advising Salix on both the acquisition ...

Sunshine Act Data Collection to Begin August 1

Medical device manufacturers are just days away from being required to track and report financial arrangements with health care providers, as required by the Physician Payment Sunshine Act (the “Sunshine Act”). (Read the final rule.) Beginning August 1, 2013, most device manufacturers will be required to annually collect data regarding payments and transfers ...

CMS Issues Sunshine Act Final Rule and Requires Data Collection for 2013

On February 8, 2013, the Centers for Medicare and Medicaid Services (CMS) published its much-anticipated final rule implementing Section 6002 the Patient Protection and Affordable Care Act, known as the Sunshine Act. The Sunshine Act requires applicable manufacturers to collect and report to CMS data on payments and transfers of value made to physicians and...… ...

Sunshine Act Final Rule Moves to OMB

On November 27, the Centers for Medicare & Medicaid Services (CMS) sent its final rule implementing the “Sunshine Act” to the Office of Management and Budget (OMB) for review. OMB review and approval is the final step before the regulation is released and published in the Federal Register. CMS published a proposed rule in December...… Continue Reading

“Modest Meals” Regulation Finalized In Massachusetts

On November 21, the Massachusetts Public Health Council adopted final regulations governing the definition of “modest meals” provided in connection with an educational presentation by a medical device or pharmaceutical company held outside of a physician’s office or hospital. The regulations finalize emergency amendments adopted in October following changes to ...

Covington Advises Meda on Acquisition of Jazz Pharmaceuticals’ Women’s Health Products

LONDON, 06 September, 2012 — Covington & Burling LLP acted as legal advisers to Meda in an agreement with Jazz Pharmaceuticals to acquire a portfolio of six pharmaceutical products for women for $95 million in cash. The largest and most important product in the portfolio is Elestrin, a patented product with sales of almost 100 MSEK, that doctors prescribe for ...

Covington Represents Eisai In $205 Million Acquisition of Four Oncology-Related Products

WASHINGTON, D.C., September 13, 2006 — Covington represented both Eisai Co., Ltd. and Eisai Inc. in the recent $205 million product acquisition agreement with Ligand Pharmaceuticals. Eisai obtained exclusive global rights to four products, including ONTAK®, Targretin® capsules, Targretin® 1% gel and Panretin® 0.1% gel. This acquisition will help to ...

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Education

University of Michigan Law School, J.D., 2004

University of Michigan School of Public Health, M.P.H., 2004

Carnegie Mellon University, M.A., 1998

Northwestern University, B.A., 1997

Judicial Clerkship

Bar Admissions