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- Home
- Professionals
- Stefanie A. Doebler
Stefanie Doebler is co-chair of the firm's Health Care Practice Group, and a member of the Food, Drug, and Device Practice Group. Her practice focuses on health care compliance matters for pharmaceutical, biotech, and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, transparency requirements, state law compliance and reporting regulations, interactions with health care professionals, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices. Ms. Doebler also advises on the development and implementation of health care compliance programs.
- Advice to trade association regarding implementation of the federal Sunshine Act and related advocacy before CMS; ongoing interaction with CMS on implementation issues.
- 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 research activities of a large medical device company to identify high-risk initiatives.
- Representation of major pharmaceutical company in criminal investigation under the FDCA regarding alleged off-label promotion.
- Internal investigation for a pharmaceutical company regarding its publications policies and practices.
Pro Bono
- 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.
March 9, 2021, Covington Alert
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 February, the Office of Prescription Drug Promotion (OPDP) posted the following warning letters on FDA’s website[1]: ...
January 26, 2021, Covington Alert
This e-alert reviews trends emerging from warning letters and untitled letters concerning product advertising and promotion issued in 2020 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 (OCBQ) of the ...
Covington's London Public Company Practice Closes a Strong Year of Life Sciences Transactions
January 25, 2021
LONDON–Covington’s London corporate team has advised AIM- and Main Market-listed clients on multiple fundraisings and acquisitions over the past few months, marking a strong year in life sciences transactions. These include: Advising Sensyne Health plc, a UK clinical AI company listed on the London AIM market, on its £27.5 million equity fundraising The ...
January 25, 2021
LONDON—Covington advised Nasdaq-listed Oxford Immunotec Global PLC in its agreement to be acquired by PerkinElmer, Inc., in a deal valued at approximately $591 million. Under the terms of the acquisition, Oxford Immunotec shareholders will be entitled to receive $22.00 in cash for each outstanding ordinary share. The terms of the acquisition value Oxford ...
December 10, 2020, Covington Alert
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 November, the Office of Prescription Drug Promotion (OPDP) posted the following untitled letter on FDA’s website: ...
November 24, 2020, Covington Alert
On Friday, November 20, 2020, the Centers for Medicare and Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) finalized two rules: (1) the “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” rule (the “AKS Final ...
November 9, 2020, Covington Alert
Now that former Vice President Biden has been projected to win the 2020 U.S. Presidential Election, expect the transition to commence from the Trump Administration to a Biden Administration. Control of the U.S. Senate remains in the balance with two runoff elections in Georgia on January 5, but either way, the Senate majority will be razor thin and hence less ...
October 12, 2020, Covington Alert
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 September, the Office of Prescription Drug Promotion (OPDP) posted three warning letters on FDA’s website, including ...
October 1, 2020
WASHINGTON—Covington has promoted 14 lawyers to its partnership. “Our new partners practice in a wide range of the firm’s key practices and add importantly to our strengths,” said Doug Gibson, Covington’s chair. “This new partner class demonstrates that we continue to build an exceptional pipeline of superbly talented lawyers, across our offices and ...
September 11, 2020, Covington Alert
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.
May 15, 2020, Covington Alert
On May 7, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced that it had finalized the Notice of Benefit and Payment Parameters for 2021 (“2021 NBPP Final Rule”). The final rule, which will go into effect on July 13, 2020, expressly allows certain health plans to determine, to the extent permitted by state law, whether to count pharmaceutical ...
CMS Announces New Flexibilities For Coverage of Medicare Part B Drugs Administered in a Home Setting
April 22, 2020, Covington Alert
On March 30, 2020, CMS announced that, in light of the coronavirus pandemic, it would be waiving several Medicare reimbursement regulations to permit reimbursement to providers treating patients remotely, consistent with current social distancing guidelines, and would be allowing providers to receive reimbursement for Medicare Part B drugs that are administered ...
April 1, 2020, Covington Alert
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.
February 27, 2020, Covington Digital Health
Practice Fusion, Inc. (Practice Fusion), an electronic health record (EHR) vendor acquired by Allscripts in 2018, recently agreed to pay $145 million to resolve criminal and civil investigations related to an illegal kickback arrangement with a major opioid company. The settlement included $26 million in criminal fines and forfeiture to resolve two felony ...
February 26, 2020, Covington Alert
On January 27, Practice Fusion, Inc. (“Practice Fusion”), an electronic health record (“EHR”) company acquired by Allscripts in 2018, agreed to pay $145 million to resolve criminal and civil investigations with the Department of Justice (“DOJ”) related to an illegal kickback arrangement with a major opioid company. Practice Fusion solicited and received nearly ...
February 24, 2020, Covington Alert
This e-alert reviews trends emerging from warning letters and untitled letters concerning product advertising and promotion issued in 2019 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 (OCBQ) of the ...
January 21, 2020, Covington Alert
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.
January 8, 2020, Covington Alert
On December 31, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a final rule updating the Medicaid Drug Rebate Program (“MDRP”) regulations to, among other things, facilitate value-based purchasing (“VBP”) arrangements for prescription drugs, expand the universe of drugs that would be considered line extensions, and ...
December 20, 2019, Covington Alert
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.
October 17, 2019, Covington Alert
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.
September 12, 2019, Covington Alert
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 July and August, the Office of Prescription Drug Promotion (OPDP) posted enforcement letters on FDA’s website.
July 18, 2019, Covington Alert
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.
March 14, 2019, Covington Alert
This alert is part of a series of 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.
February 1, 2019, Covington Alert
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 ...
January 31, 2019, Covington Alert
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 ...
November 20, 2018, Covington Alert
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.
November 12, 2018
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 ...
September 19, 2018, Covington Alert
This alert is part of a series of 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.
March 15, 2018, Covington Alert
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.
March 9, 2018, Covington Alert
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.
February 9, 2018, Covington Alert
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.
January 26, 2018, Covington Alert
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 ...
January 9, 2018, Covington Alert
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.
December 12, 2017, Covington Alert
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.
November 8, 2017, Covington Alert
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 ...
October 11, 2017, Covington Alert
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 ...
October 10, 2017, Covington Alert
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.
September 20, 2017, Covington Alert
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.
June 6, 2017, Covington Alert
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 ...
January 30, 2017
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 ...
January 9, 2017, Covington Alert
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
April 1, 2016
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, ...
February 1, 2016, Covington Alert
January 2016, Covington Alert
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 ...
Build Compliance Practices to Match Business Needs
September 17, 2015, CBI Compliance Congress for Specialty Products
August 17, 2015, Covington Alert
August 11, 2015, Covington Alert
Managing the Effects of Reporting— Responding to Alleged Inconsistencies; Handling Physician Disputes; and Minimizing the Potential Impact of Spend on Public Perception
June 8, 2015, ACI Sunshine Act Compliance & Aggregate Spend Reporting
Claims Substantiation & Comparative Claims: Learning from FDA Warning and Untitled Letters
June 3, 2015, RAPS Advertising, Promotion and Labeling: the US Regulated Environment
May 4, 2015, Covington E-Alert
The Impact of Open Payments on Fair Market Value
March 3, 2015, CBI, Pharmaceutical Compliance Congress
October 27, 2014, Covington E-Alert
The Devil is in the Details: Best Practices for Handling the Gray Areas in Reporting
October 20, 2014, ACI Sunshine Act, Open Payments, and Aggregate Spend Compliance
September 2, 2014, Covington E-Alert
August 5, 2014, Covington E-Alert
July 2, 2014, Covington E-Alert
June 5, 2014, Covington E-Alert
May 1, 2014
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 ...
April 30, 2014, Covington E-Alert
Claims Substantiation & Comparative Claims: Learning from FDA Warning and Untitled Letters
April 30, 2014, RAPS Advertising, Promotion and Labeling: the US Regulated Environment
April 25, 2014, Covington E-Alert
April 1, 2014, Covington E-Alert
Multi-State Survey—Adjusting Compliance Programs from Standard Models in order to Meet Varied State Guidelines
March 21, 2014, ACI National Pharmaceutical Compliance and Enforcement Forum
March 4, 2014
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 ...
Reporting Obligations of the Physician Payments Sunshine Act and Compliance Implications
February 28, 2014, ABA Emerging Issues in Healthcare Law Summit Conference
February 28, 2014, Covington E-Alert
January 29, 2014, Covington E-Alert
11/07/2013
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 ...
Promotional Speaker Programs and Continuing Medical Education: What You Need to Know When Managing the Complicated New Rules for These Programs
October 7, 2013, American Conference Institute's 5th Annual Forum on Sunshine Act Compliance & Aggregate Spend Reporting
The Sunshine Act: How to Avoid Getting Burned by Health Care Reform
June 4, 2013, ABA
April 29, 2013, RAPS Advertising, Promotion and Labeling: the US Regulated Environment
Disclosure Reporting
November 14, 2012, AdvaMed Physician Payments Sunshine Act Seminar for Medical Devices
November 2012, Regulatory Focus
Comprehensive State-by-State Breakdown of Disclosure and Reporting Requirements
10/16/12 - 10/17/12, American Conference Institute's 4th Annual Forum on Physician Payments Disclosure & Aggregate Spend
Covington Advises Meda on Acquisition of Jazz Pharmaceuticals’ Women’s Health Products
September 6, 2012
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 ...
August 10, 2012, Covington E-Alert
May 7, 2012, Covington E-Alert
CMS Issues Proposed Rule to Implement Drug Pricing and Rebate Provisions of the Affordable Care Act
February 10, 2012, Covington E-Alert
January 3, 2012, Covington E-Alert
December 30, 2011, Covington E-Alert
Anticipating 2013: Managing Relationships Downstream with HCPs and Consumers in Light of Disclosure
October 18, 2011, ACI Physician Payments Disclosure & Aggregate Spend Conference
March 9, 2011, Covington E-Alert
Promoting Transparency in Clinical Trials: Navigating the Complicated Intersection of State and Federal Laws Regarding Disclosure and Reporting Requirements
January 26, 2011, American Conference Institute 13th National Conference on Clinical Trials
June 3, 2010, Covington E-Alert
Health Reform: Sunshine Act and Sample Transparency
May 25, 2010, TGaS Advisors 2011 Commercial Operations Summit
April 28, 2010, Covington E-Alert
Clinical Trial Registry Laws: Compliance Considerations & Implementation Issues
February 23, 2010, 12th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials
Jan 28th, 2010, Covington E-Alert
November 30, 2009, Covington E-Alert
Mastering the Mechanics of the Final DRA Rule for Medicaid Price Reporting
November 12, 2009, American Conference Institute’s 4th Annual Rx Drug Pricing Boot Camp
October 30, 2009, Covington E-Alert
US FDA Signals Increased Enforcement Activity Against Prescription Drug Advertising and Promotion
October 2009, RAJ Pharma
Clinical Trial Registries: Implementation and Challenges in the Drug Industry
September 14, 2009, 2009 RAPS Annual Conference & Exhibition
August 31, 2009, Covington E-Alert
August 26, 2009, Covington E-Alert
July 27, 2009, Covington E-Alert
June 24, 2009, Covington E-Alert
March 30, 2009, Covington E-Alert
March 20, 2009, Covington E-Alert
March 17, 2009, Covington E-Alert
February 17, 2009, Covington E-Alert
January 15, 2009, Covington E-Alert
December 23, 2008, Covington E-Alert
December 1, 2008, Covington E-Alert
November 18, 2008, Covington E-Alert
Testimony before the Texas Department of State Health Services regarding drug pedigrees
October 2, 2008, on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA)
August 11, 2008, Covington E-Alert
July 11, 2008, Covington E-Alert
June 9, 2008, Covington E-Alert
State Regulation of Prescription Drug Marketing
May 20, 2008, Thompson Interactive
Follow-on Biologics: How the Current Legislative Models Could Change the Pharma Industry
February 25, 2008, The Center for Business Intelligence
February 12, 2008, Covington E-Alert
Strategies for Navigating New Pharma State Gift Laws
January 8, 2008, FDAnews Audioconference
November 6, 2007, Covington E-Alert
September 5, 2007, Covington E-Alert
Testimony before the Wisconsin Senate Committee on Public Health, Senior Issues, Long-Term Care and Privacy regarding prescription drug advertising
August 15, 2007, on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA)
August 7, 2007, Covington E-Alert
DDMAC Warning Letters: Avoid Regulatory Action
May 9, 2007, FDAnews Audioconference
May 3, 2007, Covington E-Alert
February 6, 2007, Covington E-Alert
January 12, 2007, Covington E-Alert
Covington Represents Eisai In $205 Million Acquisition of Four Oncology-Related Products
9/13/2006
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 ...
2006, The Wayne Law Review
- Washington DC Super Lawyers, FDA "Rising Star" (2014-2015)
- Klepper Prize for Volunteer Excellence, Legal Aid Society of the District of Columbia (2014)
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