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- Home
- Practices and Industries
- Regulatory and Public Policy
- Health Care
Players in the health care field turn to Covington because they recognize that navigating government regulation is fundamental to their success. Our clients include pharmaceutical and biotech manufacturers, medical device manufacturers, health plans, providers, technology vendors and investors. We advise clients on coverage, coding and payment; compliance with fraud and abuse laws; protecting health information; accurate price reporting; and a host of other health care regulatory issues, both within the United States and globally.
Our experience includes counseling and representation in the following areas:
- Affordable Care Act
- Anti-Kickback, Stark self-referral prohibitions and related state laws
- Common rule on protections for human research subjects
- DRGs and reimbursement of hospital treatments
- eHealth, mHealth and telemedicine
- Electronic health records and meaningful use
- False Claims Act
- Graduate medical education
- Health Insurance Exchanges and Qualified Health Plans
- Health privacy and data protection, HIPAA, HITECH
- Home and community-based supports and services
- Marketing rules and restrictions
- Medicaid drug pricing and rebates
- Medicare Part D
- Out-of-network reimbursement
- Regulation of interactions with health care professionals
- Reimbursement for services, medical devices and drugs, Medicare coverage, and coding
- State Medicaid programs and State Demonstration Programs
- State licensing and scope of practice
- Sunshine Act and international transparency rules
- UK NICE Pharmaceutical Price Regulation Scheme (PPRS)
- Wellness programs
- 340B drug pricing and reporting
Kos Pharmaceuticals Medicare Part D coverage
Assisted Kos Pharmaceuticals in obtaining Medicare Part D coverage for its previously excluded product.
Medicaid coverage for dropped products
Assisted several pharmaceutical manufacturers in reinstating Medicaid coverage for products dropped from the program by the Centers for Medicare & Medicaid Services (CMS).
Anti-kickback safe harbors
Developed for a major pharmaceutical client proposals for new potential safe harbors under the federal anti-kickback statute for potential submission to the OIG.
Healthcare business corporate structure and governance
Advice to a major pharmaceutical in establishing a healthcare business in the UK, including strategic advice on corporate structure and governance issues and compliance with Vare Quality Commission standards.
Prescription drug user privacy litigation
Advised a large pharmaceutical company in connection with litigation involving the alleged infringement of patient privacy by a pharmacy chain that collects personal information about prescription drug users.
HealthSouth Senior Notes Offering
Represented HealthSouth Corporation in its public offering of $300 million of its 5.125% senior notes due 2023.
Advising Large Public Companies and Investors on Corporate Governance Matters
Represented boards in the pharmaceuticals, consumer goods, health insurance, home equipment, advertising, motor vehicles, network communications, and technology industries as well as hedge funds, public pension funds, and other investors with respect to corporate governance developments regarding board and committee composition, crisis management, cybersecurity, internal controls, shareholder proposals, proxy access, political spending, and other sensitive disclosures and similar matters.
Healthcare Services and Solutions Collaboration Agreement with MedCPU
Represented Healthcare Services and Solutions in a collaboration agreement with MedCPU for the development of a new clinical-decision support system and related services.
Pharmaceutical manufacturer
We represented a pharmaceutical manufacturer during debate on the Patient Protection and Affordable Care Act (ACA) with regard to Medicare payment reform provisions.
Pharmaceutical public policy and government affairs
We advise a major pharmaceuticals and health care products company on a wide range of U.S. issues, including Medicare/Medicaid coverage and reimbursement matters related to medical devices, reauthorization of nutrition programs and food labeling policy and tax policy and assist them in advancing their domestic legislative and policy objectives. We also provide global public policy advocacy in countries around the world and in international regulatory bodies.
Class action FLSA consent judgment
Negotiated on behalf of a major health care network a class action FLSA consent judgment with the U.S. Department of Labor relating to overtime that avoided liquidated damages and civil money penalties while foreclosing any private right of action.
Government of Puerto Rico
We assisted the Government of Puerto Rico during debate on the Patient Protection and Affordable Care Act (ACA) in its efforts to secure parity in federal funding of its Medicaid program.
Health IT, LDT Regulatory Advocacy
Advocacy before Congress, FDA, and other federal agencies with respect to emerging regulatory policies on health information technology, research use products, and laboratory developed tests.
Securities Counsel to Numerous Fortune 500 companies
Represent numerous Fortune 500 companies in the pharmaceuticals, consumer goods, health insurance, home equipment, advertising, motor vehicles, network communications, and technology industries with respect to the resolution of shareholder proposals concerning executive compensation, majority voting, proxy access, the right to call special meetings, political spending and lobbying disclosures, and a host of other topics.
Share Repurchase Programs
We routinely represented Fortune 500 companies in the pharmaceuticals, consumer goods, and health insurance industries with respect to multibillion dollar share repurchase programs.
Trusted Advisor to Fortune 100 Companies
Represent Fortune 100 companies in the consumer goods, health insurance, and technology industries with respect to sensitive, ongoing securities disclosure, and compliance matters.
Declination in Investigation of Pharmacy Management Software
Represented biotech company in obtaining civil declination in matter concerning pharmacy management system software.
Declination of Civil and Criminal Claims in Manufacturing Investigation
Represented biopharmaceutical manufacturer in obtaining criminal and civil declination of investigation concerning alleged cGMP violations.
Declination of Civil and Criminal Claims in Kickback Investigation
Represented pharmaceutical manufacturer in obtaining civil and criminal declination in federal investigation concerning alleged payment of kickbacks to influence formulary position.
Summary Judgment under California’s Insurance Frauds Prevention Act
Won summary judgment for a medical device manufacturer under California far-reaching law that permits qui tam claims on behalf of private insurance companies.
Defense of Whistleblower Retaliation Case
Won summary judgment and First Circuit affirmance for GlaxoSmithKline in a whistleblower retaliation lawsuit.
"Public Disclosure Bar" Dismissal for Clinical Laboratory
Represented a leading clinical laboratory in a successful motion to dismiss and Third Circuit appeal under the “public disclosure bar” in connection with qui tam allegations related to the provision of free medical supplies to the laboratory’s customers.
Declination in Reverse False Claims Investigation
Represented pharmacy chain in obtaining civil declination in federal investigation of alleged retention of overpayments under the False Claims Act.
Medical device company legislative support
We assisted a medical device company in its efforts to secure Medicare pass-through coverage of its innovative diagnostic device.
Medicare Part D coverage for pharma product
We assisted a pharmaceutical company in obtaining Medicare Part D coverage for its previously excluded product, using an integrated regulatory and legislative strategy.
National Federation of Independent Business v. Sebelius
The Supreme Court appointed Covington’s Robert Long to brief and argue a preliminary issue in this case: whether the Anti-Injunction Act barred challenges to the minimum coverage provision of the Patient Protection and Affordable Care Act of 2010. Covington’s arguments were relevant to the Court’s ultimate holding that Affordable Care Act’s penalty for failing to obtain health insurance is a tax for constitutional purposes.
Reinstating Medicaid coverage
We assisted several pharmaceutical manufacturers in reinstating Medicaid coverage for products dropped from the program by the Centers for Medicare & Medicaid Services (CMS).
State of Louisiana
We assisted the State of Louisiana in securing amendment in the Patient Protection and Affordable Care Act to modify federal matching funds to reflect impact of Katrina on the State’s per capita income.
TRICARE-Related Advocacy
We achieved a significant legislative victory for a major retail corporation when Congress passed the FY 2017 National Defense Authorization Act with new authorities to expand patients’ access to retail pharmacies. Our objective was to overcome the exclusion of chain and local pharmacies from providing brand maintenance drugs under TRICARE at the same rates available for prescriptions filled at military treatment facilities or through mail-order pharmacies, which caused significant losses to chain and local pharmacy businesses and limited beneficiaries’ access to retail pharmacies. Our efforts led to the inclusion of a pilot program allowing pharmacies to provide brand maintenance drugs to TRICARE beneficiaries. The bill passed with overwhelming support in both the House (375-34) and the Senate (92-7).
Resolved Federal and State Investigation of Speaker Programs
Represented Salix Pharmaceuticals, Inc. in civil settlement of federal and state investigation of allegations concerning speaker programs.
Dismissal of Medicare Overbilling Allegations
Represented McKesson Provider Technologies in Northern District of Texas case involving FCA and supplemental state law claims, securing dismissal under Rules 9(b) and 12(b)(6) of alleged submission of purportedly false medical bills.
Dismissal of Formulary-Placement Allegations
Represented Novartis Pharmaceutical Corporation in successful motion to dismiss in the District of New Jersey on allegations that the company offered discounts to influence formulary position.
Healthcare Company Human Rights Due Diligence and Infrastructure
Working with a leading healthcare company on the design and implementation of a comprehensive, global ethical sourcing program, including policies and procedures for the verification of global human rights risks associated with new and existing suppliers, the implementation of a robust human rights auditing system, and the development of internal structures assessing effectiveness of such systems and regularly engaging with relevant stakeholders.
Brexit Task Force
March 2021
Since the beginning of the Brexit process in 2016, Covington’s Brexit Task Force–comprised of over 40 lawyers and former senior diplomats and policymakers, in London, Brussels, Frankfurt, Dublin, and Washington–has advised clients in a wide range of industries on the challenges and opportunities created by this historic event. While the EU-UK negotiations have ...
February 25, 2021
WASHINGTON—Covington represented Merck & Co., Inc. in its definitive agreement under which Merck, through a subsidiary, will acquire Pandion Therapeutics, Inc., at a price of $60.00 per share in cash, representing an approximate total equity value of $1.85 billion. Pandion is a clinical-stage biotechnology company developing novel therapeutics designed to ...
February 17, 2021
WASHINGTON—Covington advised Humacyte, Inc., in its merger with Alpha Healthcare Acquisition Corp., a special purpose acquisition company. The transaction implies a pre-money valuation of $800 million for Humacyte with existing Humacyte shareholders rolling over 100% of their equity into equity of the combined company. In connection with the execution of the ...
February 16, 2021
FRANKFURT—WirtschaftsWoche, Germany’s leading business weekly news magazine, has named Covington as one of the “Top Law Firms” for Pharma & Medical Devices law and Dr. Dr. Adem Koyuncu a “Top Lawyer” in Germany. Dr. Dr. Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm's ...
February 10, 2021, Covington Digital Health
On February 9, 2021, the UK Government’s Department for Health and Social Care (“DHSC”) announced a review into the efficient and safe use of health data for research and analysis for the benefit of patients in the health sector (“Review”). The DHSC encourages stakeholder feedback in the context of the Review, and will be of...… Continue Reading
February 8, 2021, Covington Digital Health
The Federal Trade Commission (“FTC”) announced this month a proposed settlement against Flo Health, Inc. (“Flo”), the developer of popular menstrual cycle and fertility-tracking application (the “Flo App”), resolving allegations that “the company shared the health information of users with outside data analytics providers after promising that such information ...
February 8, 2021, Covington Digital Health
On January 14, 2021, the United States Court of Appeals for the Fifth Circuit vacated a $4.3 million civil monetary penalty that the Office for Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) imposed against the University of Texas M.D. Anderson Cancer Center (“M.D. Anderson”). OCR ordered the penalty in 2017...… Continue Reading
February 8, 2021, Covington Digital Health
On January 6, 2021, the UK’s AI Council (an independent government advisory body) published its AI Roadmap (“Roadmap”). In addition to calling for a Public Interest Data Bill to ‘protect against automation and collective harms’, the Roadmap acknowledges the need to counteract public suspicion of AI and makes 16 recommendations, based on three main pillars,...… ...
February 1, 2021, Covington Digital Health
On January 5, 2021, an amendment to the Health Information Technology for Economic and Clinical Health (“HITECH”) Act was signed into law. The amendment requires the U.S. Department of Health and Human Services (“HHS”) to “consider certain recognized security practices of covered entities and business associates when making certain determinations” regarding ...
January 25, 2021, Covington Digital Health
On December 23, 2020, the European Commission (the “Commission”) published its inception impact assessment (“Inception Impact Assessment”) of policy options for establishing a European Health Data Space (“EHDS”). The Inception Impact Assessment is open for consultation until February 3, 2021, encouraging “citizens and stakeholders” to “provide views on 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 21, 2021, Covington Digital Health
On 18 January 2021, the UK Parliamentary Office of Science and Technology (“POST”)* published its AI and Healthcare Research Briefing about the use of artificial intelligence (“AI”) in the UK healthcare system (the “Briefing”). The Briefing considers the potential impacts of AI on the cost and quality of healthcare, and the challenges posed by the...… Continue ...
January 15, 2021, Covington Digital Health
In addition to releasing the new EU Cybersecurity Strategy before the holidays (see our post here), the Commission published a revised Directive on measures for high common level of cybersecurity across the Union (“NIS2”) and a Directive on the resilience of critical entities (“Critical Entities Resilience Directive”). In this blog post, we summarize key ...
The Council of Europe Publishes Feasibility Study on Developing a Legal Instrument for Ethical AI
January 13, 2021, Covington Digital Health
On 17 December 2020, the Council of Europe’s* Ad hoc Committee on Artificial Intelligence (CAHAI) published a Feasibility Study (the “Study”) on Artificial Intelligence (AI) legal standards. The Study examines the feasibility and potential elements of a legal framework for the development and deployment of AI, based on the Council of Europe’s human rights ...
January 11, 2021, Covington Digital Health
On January 6, 2021 the UK’s Department of Health and Social Care (“DHSC”) published “A Guide to Good Practice for Digital and Data-Driven Health Technologies” (the “Guidance”). The Guidance updates the DHSC’s “Code of Conduct for Data-Driven Health and Care Technologies” (the “Code”) (for further information on the Code see our earlier blog, here). As...… ...
January 6, 2021
NEW YORK—Covington represented Ascension Health Alliance and TowerBrook Capital Partners L.P., joint owners of an investment vehicle, in an agreement with R1 RCM Inc., a provider of technology-enabled revenue cycle management services to healthcare workers, for the conversion of the 8% Series A Convertible Preferred Stock held by the joint investment vehicle to ...
January 6, 2021, MedTech Insight
Scott Danzis is quoted in MedTech Insight regarding the FDA’s final guidance on its new Safer Technologies Program for Medical Devices (STeP) program, which is intended to provide additional support to developers of medical devices that significantly improve on existing products. Mr. Danzis says that STeP is a "welcome complement" to the FDA's Breakthrough ...
December 17, 2020, Covington Alert
On December 10, 2020, the Supreme Court of the United States issued a decision in Rutledge v. Pharmaceutical Care Management Association holding that Arkansas’s Act 900, which regulates pharmacy benefit managers’ (“PBMs”) pharmacy reimbursement practices, is not pre-empted by the Employee Retirement Income Security Act of 1974 (“ERISA”). PBMs have long asserted ...
December 14, 2020, Inside Health Policy
Wade Ackerman spoke with Inside Health Policy about the HHS' decision to remove laboratory-developed tests from FDA oversight. Mr. Ackerman says laboratory-developed test regulation has long been a hot topic among stakeholders. “The pandemic put the nation's attention on testing, and the HHS' statement set in motion LDT regulation being an even more high-profile ...
Burr, in line to lead Senate Republicans’ health strategy, has a long history of antagonizing the FDA
December 1, 2020, STAT
Wade Ackerman is quoted in STAT regarding Senator Richard Burr’s public health policies and his bipartisan efforts. Mr. Ackerman says, “He compromises. He actually is very good to negotiate with on FDA issues because he and his staff are so knowledgeable, and do want to move forward bipartisan policy.”
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 23, 2020, Covington Alert
On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued an interim final rule (“IFR”) implementing President Trump’s Most Favored Nation (“MFN”) executive order, which would tie Medicare Part B payments for certain drugs to the lowest price paid in other economically advanced countries (the “MFN IFR”). In a press conference on November ...
November 2, 2020, Medtech Insight
Wade Ackerman is quoted in Medtech Insight regarding the impact of the 2020 presidential election on FDA regulations. Mr. Ackerman says the outcome of the election may have a significant effect on the leadership of U.S. FDA, with either winner bringing marked differences in policies and priorities. In a note to clients, he outlined some differences medtech ...
October 28, 2020, Covington Alert
The outcome of the national elections next week will have consequential implications at the U.S. Food and Drug Administration (FDA). The election may affect the composition of FDA’s leadership team, and stakeholders can expect differences in policies and priorities between a second Trump Administration and a new Biden Administration. Control of the U.S. Senate ...
October 9, 2020, The Rose Sheet
The Rose Sheet covered Gerald Masoudi and Peter Hutt’s FDA panel at the FDLI annual conference, “Time for Independent U.S. FDA? COVID-19 Political Pressure Reignites Debate.” Mr. Masoudi suggests some benefits to the current reporting structure. “If you look at the other functions within HHS with which FDA interacts on a regular basis,” such as the Centers for ...
September 25, 2020
WASHINGTON—The Deal recognized Catherine Dargan as its Healthcare, Pharma & Biotech Dealmaker of the Year at its annual “Deal Awards.” Ms. Dargan has advised numerous companies on their important strategic transactions for over 20 years. She has broad experience in mergers and acquisitions, both public and private (domestically and cross-border), and partnering ...
September 25, 2020, LexisNexis
September 22, 2020, MedTech Insight
Shankar Duraiswamy is quoted in MedTech Insight regarding the uncertainty around the Affordable Care Act’s coverage of medtech after the passing of U.S. Supreme Court Justice Ruth Bader Ginsburg. Mr. Duraiswamy points out that Justice Roberts has previously "narrowly ruled that that some parts of the ACA can be severed from the individual mandate" and remain ...
September 15, 2020, Covington Alert
The Trump Administration has released the much-anticipated executive order entitled “Lowering Drug Prices by Putting America First” (commonly referred to as the “Most-Favored-Nation” or “MFN” executive order). President Trump initially had announced the MFN executive order during his July 24, 2020 press conference highlighting four separate executive orders ...
August 27, 2020, Medtech Insight
Scott Danzis spoke with Medtech Insight about a Department of Health and Human Services announcement stripping the FDA of its oversight over Laboratory Developed Tests, or LDTs. Mr. Danzis says, “By the terms of the policy that was issued, it is not restricted to COVID-19 LDTs. It is broader than that. Moreover, we’ve had recent discussions with senior HHS ...
What The FDA’s Inspections Q&A Guidance Really Means: It’s Time To Offer Virtual Inspections
August 25, 2020, The Pink Sheet
Tom Cosgrove is quoted in The Pink Sheet regarding virtual inspections conducted by the FDA during the COVID-19 pandemic. Mr. Cosgrove says, “We were hoping to see some progress on remote or virtual facility inspections.” He notes that the agency has been working hard to avoid the need for pre-approval inspections by, for example, requesting records and talking ...
Trump's US-Made Drug Decree Sows Uncertainty In Industry
August 7, 2020, Law360
Jennifer Plitsch spoke with Law360 about a presidential executive order calling for federal agencies to be required to buy domestically produced versions of medicines. Ms. Plitsch says, “Those will be significant, certainly at the outset [of the order going into effect], in light of the current market.” She adds that under the definition of "produced in the ...
June 12, 2020, BioSpace
Wade Ackerman is quoted in BioSpace regarding the decentralization of clinical trials in the pharmaceutical industry. Mr. Ackerman says the “all hands on deck” approach to the pandemic by Congress and the FDA set the stage for clinical trial innovation. “It has set up a lot of conversations about where telehealth is, and where it will be six months from now,” he ...
June 9, 2020, STAT News
Julie Dohm is quoted in STAT News regarding the FDA’s temporary policy allowing smaller pharmacies to make certain drugs for treating COVID-19 without first receiving a patient’s prescription for the drug. The condition for this new policy is that the pharmacies sell the drugs to a hospital that can prove it could not source the drugs from elsewhere. Ms. Dohm ...
Wade Ackerman and Amy Toro Named Top Health Care Lawyers
June 8, 2020
LOS ANGELES—Daily Journal has named Wade Ackerman and Amy Toro to its 2020 Top Health Care Lawyers, a recognition of the leading California lawyers who specialize in health care litigation, transactions, and counselling. Mr. Ackerman, a partner in our Los Angeles office, advises clients on complex FDA issues that require coordinated legal, regulatory, and public ...
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 ...
April 23, 2020, Daily Journal
Wade Ackerman and Scott Danzis spoke with the Daily Journal about their work with clients on emergency use authorization (EUA) requests. Mr. Ackerman says of the firm, “One of the things I appreciate about being in California, but also part of this firm that’s deeply connected with D.C., is that we have connectivity with what’s going on at FDA and on the ...
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 20, 2020, Covington Alert
The Department of Health and Human Services (HHS) has released details relating to the disbursement of the first $30 billion of $100 billion in funding allocated by the CARES Act to the Public Health and Social Services Emergency Fund (PHSSEF). Pub. L. 116- 136, Div. B (Mar. 27, 2020). HHS began making payments to eligible providers on April 10, 2020.
April 1, 2020
WASHINGTON—The National Law Journal has named Covington's John Hurvitz to its list of “Healthcare and Life Sciences Trailblazers.” This list features 26 honorees who are recognized as “agents of change” whose work has advanced innovation in the health care and life sciences industries. Mr. Hurvitz co-chairs C&B's Life Sciences Industry Group, heads the firm's ...
April 1, 2020, Bloomberg Law
Thomas Brugato is quoted in Bloomberg Law regarding the EPA’s increased enforcement measures against products making unproven antiviral or disinfectant claims in light of the coronavirus pandemic. Mr. Brugato says, “This is the tip of the iceberg. I think we’ll definitely see more cases like this.” He adds that given the clear public health implication of the ...
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.
March 18, 2020, Politico
Scott Danzis is quoted in Politico regarding tracking medical device shortages and whether regulations requiring drug manufacturers to warn the government when a shortage seems likely should be applied to medical devices. Mr. Danzis says, “There's a balance that has to be struck between giving that information to FDA and creating additional reporting ...
Sarah Cowlishaw Named to The Lawyer “Hot 100”
January 28, 2020
LONDON—The Lawyer has named London life sciences partner Sarah Cowlishaw to its “Hot 100,” a list that recognizes the most daring, innovative and creative lawyers from in-house, private practice and the Bar around the U.K. The Lawyer highlighted Ms. Cowlishaw’s work for biotech company Sensyne Health on regulatory matters related to its AIM IPO and her ongoing ...
January 17, 2020
WASHINGTON—Covington represented Piramal Enterprises Limited in itsdefinitive agreement to sell Decision Resources Group to Clarivate Analytics plc, in a deal valued at $950 million. The $950 million purchase price includes $900 million in cash and approximately $50 million in Clarivate ordinary shares to be issued following the one-year anniversary of ...
January 17, 2020
WASHINGTON—Am Law Litigation Daily has named Covington partner Michael Imbroscio, co-chair of the firm’s Product Liability and Mass Tort practice, as a “Litigator of the Week.” Mr. Imbroscio led the defense of Eli Lilly and Company in litigation alleging that its medicine Cialis – as well as Pfizer’s medicine Viagra – could cause melanoma, convincing the trial ...
January 16, 2020
London—Covington represented Illumina on its partnership with Genomics England, to sequence up to 500,000 whole genomes for the NHS Genomic Medicine Service. This partnership is part of the wider ambition to analyse up to 5 million genomes by 2024, to enable the UK to maintain its position as a global leader in genomics. Under this partnership and guided by ...
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 ...
Health Care Cases To Watch In 2020
January 1, 2020, Law360
Anna Kraus spoke with Law360 about Texas v. U.S., a Republican-led challenge to the ACA's constitutionality. "Ultimately, the outcome of this case could affect almost everyone in the country.” She adds that the case is “by far the most important case to watch in 2020.”
January 2020
Covington has created a list of Top 10 Questions for Ideation of Digital Health Solutions that can help lawyers contribute to the digital health ideation process. Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions. "Ideation" is part of that process and involves the rapid ...
December 9, 2019
WASHINGTON—Covington represented Merck & Co., Inc. in its definitive agreement under which Merck, through a subsidiary, will acquire ArQule for $20 per share in cash for an approximate total equity value of $2.7 billion. ArQule is a publicly traded biopharmaceutical company focused on kinase inhibitor discovery and development for the treatment of patients with ...
CMS Releases Final Hospital Price Transparency Rule and Proposes Transparency Rule for Health Plans
November 27, 2019, Covington Alert
On November 27, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a final rule and proposed rule that each aim to increase the transparency of hospital and insurer prices.
Nooree Lee Receives NAPABA's Best Under 40 Award
September 25, 2019
WASHINGTON—The National Asian Pacific American Bar Association (NAPABA) has recognized Nooree Lee with its Best Under 40 Award. The award recognizes talented individuals within the Asian Pacific American legal community under the age of 40 who have achieved prominence and distinction in their fields of endeavor—be it the practice of law, academia, business, ...
FDA Focus: What Covington's Practice Chair Is Watching
May 31, 2019, Law360
Denise Esposito spoke with Law360 about hot topics involving over-the-counter medicines, drug prices, and next-generation products that blur the line between biologics and medical devices. She also predicted that new FDA Commissioner Ned Sharpless might revert to allowing directors of the agency's centers.
May 6, 2019, Medtech Insight
Medtech Insight included Pamela Forrest's comments from FDAnews' 16th Annual Medical Device Quality Congress about medical device recalls from a product enhancement. Ms. Forrest said the key question companies should ask themselves is whether their action makes a safe device better or improves existing safety concerns. If the action improves a device's safety, ...
Former FDA Drug Regulatory Adviser Joins Covington in DC
April 5, 2019, Law360
Julie Dohm was featured in Law360 regarding her move to Covington. Ms. Dohm, who joined Covington in March from the FDA, says, “I was excited about trying to get into private practice. I really want to work with people that are the pillars of food and drug law, and a number of those folks are at Covington.”
Former FDA Official Joins Covington
April 1, 2019
WASHINGTON—Julie Dohm has joined Covington's Food, Drug, and Device practice in Washington. Dr. Dohm focuses on regulatory matters for pharmaceutical and biotechnology clients. She has handled cases on a wide range of regulatory topics such as preemption, drug promotion, drug shortage, import-export, exclusivity, and generic drug approval standards. Prior to ...
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 ...
Jon Kyl Returns to Covington
January 7, 2019
WASHINGTON—Former U.S. Senator Jon Kyl has re-joined Covington in its Public Policy practice. Senator Kyl will focus on matters of policy and strategy for the firm’s clients. “We are extremely proud of Jon’s service to the country and the people of Arizona and delighted that he has rejoined us,” said Timothy Hester, Covington’s chair. “Given his profile and ...
Law360 MVP: Covington's Paul Schmidt
November 30, 2018, Law360
Paul Schmidt has been named a 2018 Product Liability MVP by Law360. The publication highlights a significant appellate victory in the New Jersey Supreme Court for his client Hoffmann-La Roche as well as multiple trial wins in other pharmaceutical cases.
November 30, 2018, Global Data Review
Trisha Anderson is quoted in Global Data Review regarding cyber and ransomware attacks. Ms. Anderson said that while the use of technologies like Tor and Bitcoin pose challenges to law enforcement by “raising the level of investigative effort and sophistication required to identify and locate cyber criminals,” the indictment in the SamSam Ransomware cyberattacks ...
United Kingdom
2018, Global Legal Insights to: Global Legal Insights - Pricing & Reimbursement 2018, 1st Ed.
Sarah Crowder Named to GIR's "Women in Investigations"
July 17, 2018
LONDON—Global Investigations Review has named Covington’s Sarah Crowder to the second edition of “Women in Investigations,” highlighting 100 female practitioners from across the globe. Nancy Kestenbaum and Mythili Raman were selected to the list’s first edition in 2015. The survey highlights a variety of women not previously recognized by the magazine—from ...
July 3, 2018, Covington Alert
In April, in Common Ground HealthCare Cooperative v. United States, 17-877C (Fed. Cl. April 17, 2018) the Court of Federal Claims granted Common Ground Healthcare Cooperative’s motion for class certification. The certified class includes all insurers offering Qualified Health Plans (QHP) under the ACA for the 2017 or 2018 benefit year that reduced cost-sharing ...
June 29, 2018, Covington Alert
In January, the Department of Labor (DOL or the “Department”) proposed a rule to allow more Association Health Plans (AHPs) to be regulated as large group health plans. The proposed rule garnered national attention and the Department received over 900 stakeholder comments from consumer groups, individual employers, employer associations, health insurance ...
June 26, 2018, Covington Alert
Earlier this year, President Trump signed into law the Bipartisan Budget Act of 2018 (BBA), which incorporates provisions from the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 and improves access to telehealth services in Medicare Advantage. Pub. L. No. 115-123.
May 22, 2018, Covington Alert
Last month, the Centers for Medicare & Medicaid Services (CMS) finalized the 2019 Notice of Benefit and Payment Parameters, which includes changes to the Affordable Care Act’s (ACA) implementing regulations. 83 Fed. Reg. 16,930 (April 17, 2018). In this advisory, we analyze the most significant of these regulatory changes, focusing on the key differences between ...
CMS Finalizes Rules Allowing Medicare Advantage Plans To Expand and Target Supplemental Benefits
May 9, 2018, Covington Alert
Under Sections 1852(d) and 1854(c) of the Social Security Act (SSA), a Medicare Advantage (MA) plan must offer uniform benefits, premiums, and cost-sharing within each “segment” in the MA plan’s service area. See 42 C.F.R. § 422.100(d). “Segments” are county-level portions of a plan’s overall service area.
March 27, 2018, Covington Alert
China has reorganized many of the ministries and commissions under its chief executive body, the State Council, creating a new super-ministry to replace the China Food and Drug Administration (“CFDA”) and other healthcare agencies.
March 13, 2018, Covington Alert
On October 12, 2017, President Trump issued an executive order, entitled “Promoting Healthcare Choice and Competition Across the United States”, that, among other things, instructed the Secretaries of Health and Human Services (HHS), Labor, and Treasury to “consider proposing regulations or revising guidance, consistent with law, to expand the availability of ...
March 6, 2018, Law360
John DeBoy is quoted in a Law360 article regarding a recent Third Circuit ruling that gives medical device makers a legal shield for products composed of parts with various levels of regulatory approval. "[The decision] marks a step forward in clarifying the law on the component question,” says DeBoy. “Some federal district courts have applied an analysis ...
March 6, 2018, Covington Alert
Last week, in New Mexico Health Connections v. United States Department of Health and Human Services (HHS), No. 16-cv-0878 (D.N.M.), the U.S. District Court for the District of New Mexico granted summary judgment for plaintiff-New Mexico Health Connections (NMHC) in a case challenging the Centers for Medicare & Medicaid Services’ (CMS) methodology implementing ...
February 6, 2018
LOS ANGELES—The Los Angeles Business Journal recognized Wade Ackerman and Aaron Lewis in its second annual list of the most influential diverse lawyers in Los Angeles. The list recognizes 50 "stellar diverse lawyers in the LA region." In Mr. Ackerman’s profile, the Business Journal emphasized his work in the FDA regulatory space. The profile noted that “with a ...
January 16, 2018, Covington Alert
On January 5, 2018, the Department of Labor (DOL or the “Department”) published a proposed rule to allow more Association Health Plans (AHPs) to be regulated as large group health plans. 83 Fed. Reg. 614 (Jan. 5, 2018) (to be codified at 29 C.F.R. pt. 2510). The proposed regulation was developed in response to President Trump’s October 12, 2017 Executive Order ...
Legislative Initiatives: Hot Topics in Health Care
December 14, 2017, PLI's Health Care Law Institute 2017
December 11, 2017, Covington Alert
On November 28, 2017, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule touching on a range of issues under the Prescription Drug Benefit (Part D) and Medicare Advantage (MA) programs, and implementing certain provisions of the Comprehensive Addiction and Recovery Act (CARA) and of the 21st Century Cures Act. 82 ...
November 13, 2017, Covington Alert
Earlier this month, the Centers for Medicare & Medicaid Services (CMS) published the long-awaited 2019 Notice of Benefit and Payment Parameters, which includes significant changes to the implementation regulations of the Affordable Care Act (ACA). 82 Fed. Reg. 51,052 (Nov. 2, 2017).
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 ...
Top 10 Game-Changing Litigator Moves in October
November 1, 2017, The Litigation Daily
The Litigation Daily recognizes Jennifer Saulino's move to Covington as one of the top "Game-Changing Litigator Moves in October." According to John Hall, “Jennifer’s skill and experience in litigating and trying fact-intensive cases combined with her track record of success in complex jury cases will benefit our clients and strengthen the firm’s general ...
November 2017, Journal of Medical Device Regulation
October 20, 2017, Covington Alert
On Tuesday, Senators Lamar Alexander (R-TN) and Patty Murray (D-WA) announced a bipartisan proposal that would fund cost-sharing reduction (CSR) payments under the Affordable Care Act (ACA) through 2019. The bill would also make other changes to the ACA, including: allowing consumers over age 30 to buy catastrophic plans; making it easier for States to obtain ...
October 13, 2017, Covington Alert
In a court filing this morning and an Executive Order issued yesterday, the Trump Administration announced major policy changes affecting health insurers and employers. The Administration intends to cease making cost-sharing reduction (CSR) payments to insurers, while also expanding the availability of Association Health Plans, short-term health plans, and ...
October 4, 2017
WASHINGTON—Jennifer Saulino has joined Covington’s Litigation and White Collar Defense and Investigation practices as a partner in Washington. Ms. Saulino’s practice focuses on trials as well as defending individuals and corporations in investigations and prosecutions, with particular experience in the pharmaceutical, health care, banking and securities, oil and ...
October 3, 2017
BEIJING—China Law & Practice has named Covington as the international winner for “Trade Firm of the Year” at its annual awards ceremony in Beijing. The leading Chinese legal publication also recognized the firm for its role in the Technology, Media, and Telecom “Deal of the Year,” Tencent’s $8.6 billion acquisition of Supercell. The awards focus on “innovation ...
Ex-FCPA unit supervisor joins Covington
October 3, 2017, Global Investigations Review
Global Investigations Review highlights Jennifer Saulino's return to Covington as a partner in its Litigation and Investigations practice.
Former DOJ Prosecutor Rejoins Covington In Washington
October 3, 2017, Law360
John Hall and Jennifer Saulino are quoted in a Law360 article regarding her return to Covington as a partner in the firm's Litigation and Investigations practice. According to Hall, Saulino has “earned the respect and admiration of her colleagues and adversaries” in the courtroom with both her skills and her willingness to take on the most difficult cases. ...
October 2017, Digital Health Legal
September 12, 2017, Covington Alert
While Congressional Republicans’ efforts to repeal and replace the Affordable Care Act (“ACA”) stalled at the end of July when the Senate was unable to pass repeal-and-replace legislation, a number of Senators are continuing to work on legislation to make changes to the ACA.
June 29, 2017, Covington Alert
Last week, Senate Republican leadership released the Better Care Reconciliation Act of 2017 (BCRA), which would repeal and replace the Affordable Care Act (ACA). While Senate Republicans do not yet have the requisite votes to pass the legislation, and did not start the debate this week as planned, the bill is still very much alive. Senate Republicans continue to ...
U.S. FDA's New Game Plan For Digital Health
June 16, 2017, Medtech Insight
Wade Ackerman is quoted in a Medtech Insight article regarding FDA's regulatory strategy in relation to digital health. "While Congress addressed some aspects of FDA's regulation of health software in the 21st Century Cures Act last year, the digital landscape continues to evolve rapidly," Ackerman says. "FDA's intent to outline a new digital health innovation ...
May 9, 2017, MedTech Insight
Wade Ackerman is quoted by MedTech Insight in an article covering the May 5 Food, Drug and Law Institute's annual meeting in Washington. Ackerman provided his insights on the hiring trajectory for those individuals tasked to implement the 21st Century Cures Act, and noted that the funds can be viewed as having broad applications for hiring. Ackerman stated, ...
May 3, 2017, Covington Alert
Last week, Representative Thomas MacArthur (R-N.J.) proposed an amendment (the “MacArthur Amendment”) to the American Health Care Act (AHCA) in an effort to resuscitate the Republican bill that Speaker Paul Ryan pulled from the House floor last month. The MacArthur Amendment makes several changes to the AHCA, which we summarized in Advisories 17-9 and 17-10.
April 18, 2017, Covington Alert
Last Thursday, the Centers for Medicare & Medicaid Services (CMS) finalized the Affordable Care Act (ACA) market stabilization rule, which it originally proposed in February, 82 Fed. Reg. 10,980 (Feb. 17, 2017). This final rule was published today in the Federal Register and will become effective on June 19, 2017. 82 Fed. Reg. 18,346. The final rule includes ...
Covington & Burling Adds Ex-Tyco Counsel In M&A Practice
April 13, 2017, Law360
Thomas Repke is quoted in a Law360 article regarding his arrival to the firm’s Mergers and Acquisitions practice. “This is an opportunity to share best practices, put the best teams together, which the firm is really conducive to,” Repke says. “Providing excellence in client service and that’s really the goal. Having been in-house for the past seven years, ...
Covington Adds Senior M&A Partner
April 4, 2017
WASHINGTON—Thomas Repke, who has extensive M&A private practice and in-house experience, has joined Covington as a partner in its Mergers and Acquisitions practice in Washington. Most recently, Mr. Repke served as lead counsel for Tyco on all M&A, divestiture, joint venture, and investment transactions across all business units. While at Tyco, he helped ...
April 3, 2017, Covington Alert
On March 24, 2017, Speaker Ryan pulled the American Health Care Act (“AHCA”) from the House floor and announced that the Affordable Care Act (“ACA”) would remain in place “for the foreseeable future.” Since that time, there has been considerable speculation about what comes next for the ACA, both in Congress and with respect to administrative action by the Trump ...
March 30, 2017
SILICON VALLEY—Former Patent Trial and Appeal Board (PTAB) judges Peter Chen and Scott Kamholz have joined Covington’s Patent Office Trials Practice. Mr. Chen and Dr. Kamholz are the only former PTAB judges to enter private practice who have overseen Leahy-Smith America Invents Act of 2011 (AIA) trial proceedings from institution through final decision. Peter ...
GDPR Planning and Preparation Conference for Employers
March 30, 2017, Business Forums International Ltd.
March 13, 2017, Covington Alert
Last week, House Republicans introduced long-awaited legislation, through “budget reconciliation,” to “repeal and replace” the Affordable Care Act (ACA). The American Health Care Act (AHCA) makes major changes to current law.
Life Sciences Group Of The Year: Covington & Burling
February 10, 2017, Law360
Law360 selected Covington’s Life Sciences practice as a “Practice Group of the Year,” highlighting the firm’s involvement in billion-dollar transactions, success in contentious litigation, and regulatory advice on cutting-edge technology. According to Michael Labson, “What we offer and bring to complicated, complex issues is a mixture of deep subject-matter ...
February 3, 2017, Global Investigations Review
Ian Hargreaves and David Lorello are quoted in a Global Investigations Review article regarding Hargreaves’ recent arrival to Covington. According to Hargreaves, the firm’s “pre-eminence in dispute resolution, and its immense strength and global recognition as a market-leader in white-collar crime matters and investigations” fueled his decision. Lorello says, ...
January 31, 2017
LONDON—Ian Hargreaves has joined Covington as a partner in the firm’s European Dispute Resolution practice resident in London. Mr. Hargreaves’ arrival follows that of litigation partners Craig Pollack, Greg Lascelles, Elaine Whiteford, and Louise Freeman over the past six months. Mr. Hargreaves advises on major European white collar and related civil and ...
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 24, 2017, Covington Alert
On January 20, 2017, President Donald J. Trump signed an Executive Order instructing federal agencies to work to “minimize the unwarranted economic and regulatory burdens” of the Affordable Care Act (“ACA”), and to increase the flexibility provided to States to run healthcare programs. (The text of the order can be found at the end of this advisory.) While the ...
Wearable technology: gathering data from tooth to toe
November 21, 2016, Financial Times
Daniel Cooper is quoted in a Financial Times article regarding wearable technology in the workplace. According to Cooper, not everyone will welcome sharing intimate personal information with the boss, however. “Wearable devices could be a good way for insurers to get the data . . . but it’s essential to address wearers’ privacy and fair treatment concerns and ...
November 4, 2016, FDA Week
Michael Labson spoke at the FDLI Annual Advertising Conference and is quoted in an FDA Week article regarding communication between drug makers and payers under a section of the FDA Modernization Act. According to Labson, first amendment jurisprudence may make concerns over FDAMA 114 a non-issue. "If the first amendment idea that you have a constitutional right ...
POLITICO Pro Morning Health Care, presented by Lilly: Brexit wobble — WHO DG candidates compete
November 4, 2016, Politico Pro
Brian Kelly and Grant Castle are quoted in a Politico Pro “Morning Health Care” article regarding the High Court ruling that the UK government does not have the legal power to invoke Article 50 without Parliamentary approval. According to Kelly, “This presents an opportunity for individual companies and the industry to engage with members of Parliament to ensure ...
October 2016, Digital Health Legal
Prominent Medical Device Lawyer Joins Covington
September 22, 2016
WASHINGTON—Pamela Forrest has joined Covington in its Food, Drug, and Device practice, resident in Washington. Ms. Forrest has more than 20 years of experience advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket review, product recalls, medical device reporting (MDR), Quality System ...
September 13, 2016, Daily Journal
Tom DeFilipps and Doug Gibson are quoted in a Daily Journal article regarding DeFilipps’ move to Covington’s Silicon Valley office. Commenting on the draw to Covington DeFilipps says, “One of the more compelling aspects of the Covington platforms is the way it allows you to meld the strength of its regulatory practice in D.C. and non-U.S. jurisdictions, like ...
September 13, 2016, The Recorder
Tom DeFilipps and Doug Gibson are quoted by The Recorder in an article regarding DeFilipps’ recent move to Covington, where he will serve as chair of the West Coast corporate practice. According to DeFilipps, “Covington presented to me an opportunity to do something that sounded very interesting at this point in my career.” He continues, "I felt as though it was ...
Silicon Valley Dealmaker Joins Covington
September 13, 2016, ABF Journal
Timothy Hester and Tom DeFilipps are quoted in an ABF Journal article regarding the arrival of DeFilipps to Covington. According to Hester, “Adding Tom to our Silicon Valley office is a major step forward in our plan for continued growth in California.” DeFilipps says, “I am very pleased to join Covington’s growing California practice.” He continues, “I am ...
Leading Silicon Valley Dealmaker Joins Covington
September 12, 2016
SILICON VALLEY—Tom DeFilipps has joined Covington as a partner in the Silicon Valley office and will serve as chair of the West Coast Corporate practice. “Adding Tom to our Silicon Valley office is a major step forward in our plan for continued growth in California,” said Timothy Hester, Covington’s chair. “Tom has built a successful Northern California ...
September 12, 2016, Law360
Timothy Hester and Tom DeFilipps are quoted in a Law360 article regarding DeFilipps’ recent arrival. According to Hester, “Adding Tom to our Silicon Valley office is a major step forward in our plan for continued growth in California.” He continues, “Tom has built a successful Northern California corporate practice over many years and has a demonstrated track ...
June 30, 2016
On June 23, the Centers for Medicare & Medicaid Services (“CMS”) published its final rule to implement Medicare laboratory policy changes made under Section 216(a) of the Protecting Access to Medicare Act of 2014 (“PAMA”). Responding to public comments it received on last year’s proposed rule, CMS made a number of significant changes and postponed the PAMA ...
UK Votes to Leave the EU
June 24, 2016, Covington Alert
The UK has voted to leave the European Union in an advisory referendum. 52% leave - 48% remain. Were the UK to leave the EU, this would have significant implications for the UK and for international businesses operating in the UK. The longer term impact of the decision on the regulatory framework for the UK will depend, in part, on the relationship that the UK ...
Covington Receives Top Rankings from Chambers USA
June 7, 2016
WASHINGTON—Covington has again received top rankings from Chambers USA, with 60 practice rankings and 120 individual rankings for lawyers in the publication’s 2016 edition. The legal guide identifies leading lawyers and law firm practices based on interviews conducted by Chambers’ researchers with thousands of lawyers and their clients. The firm was ranked in ...
April 14, 2016, Covington Alert
It has now been a full year since the Food and Drug Administration (“FDA”) approved the first biosimilar product to proceed under the new abbreviated biological pathway. With recent spotlights on the cost of pharmaceutical drug products, the potential of biosimilars to offer patients additional and more affordable choices has been widely discussed. Most ...
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 ...
December 8, 2015
NEW YORK, December 8, 2015 - Covington represented Ascension, the nation’s leading Catholic and non-profit health system, in a $200 million investment transaction with TowerBrook Capital Partners in Accretive Health, a leading provider of revenue cycle management services to healthcare providers. The transaction is expected to close in the first quarter of ...
CMS Issues Delayed Proposed Rule Implementing PAMA’s New Clinical Laboratory Reimbursement Criteria
October 7, 2015, Covington Alert
European Union: Pharmaceuticals
August 2015, An Extract from The European Antitrust Review 2016
July 13, 2015, BNA’s Health Care Policy Report
Moving to the Cloud: Privacy and Other Key Considerations for Healthcare Entities
May 13, 2015, Life Sciences Essentials Webinar Series
May 4, 2015, Covington E-Alert
April 13, 2015, BNA’s Health Care Policy Report
March 9, 2015, The National Law Journal
December 23, 2014, Covington E-Alert
October 27, 2014, Covington E-Alert
Start To Think About Entering China's Health Care Market
October 17, 2014, Law360
Tim Stratford authored this article on China’s tightly regulated health care sector: "The Chinese government has announced the launch of a pilot scheme allowing for the establishment of wholly foreign-owned hospitals (“WFOHs”) through greenfield investment or mergers and acquisitions in three centrally governed municipalities (Beijing, Tianjin and Shanghai), ...
July 30, 2014, Legal Business
Lucinda Osborne, Gregor Frizzell, Christopher Walter and Miranda Cole are mentioned regarding their representation of AstraZeneca on its £1.2bn acquisition of Spanish healthcare group Almirall’s respiratory unit.
June 5, 2014, Covington E-Alert
March 25, 2014, Covington Advisory
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 ...
January 10, 2014, Covington E-Alert
December 31, 2013, Covington E-Alert
November 8, 2013, Covington E-Alert
Covington Wins Six LMG Life Sciences Awards
9/27/2013
NEW YORK, September 27, 2013 — Covington & Burling received six awards at the inaugural LMG Life Sciences awards on September 25, including “FDA Pharmaceutical Firm of the Year” and Richard Kingham’s induction to the Hall of Fame. The awards, which are selected based on a survey of peers and leading companies in the life sciences industry, “recognize and honor ...
July 26, 2013, Covington E-Alert
Congressional Leader Howard Berman Joins Covington
March 14, 2013
WASHINGTON, DC, March 14, 2013 — Congressman Howard Berman, a widely respected leader in the U.S. Congress, is joining Covington & Burling’s global public policy and government affairs practice. The addition of Rep. Berman, the former chairman of the House Foreign Affairs Committee, comes a week after Sen. Jon Kyl joined Covington’s public policy and government ...
Senator Jon Kyl Joins Covington
March 6, 2013
WASHINGTON, DC, March 6, 2013 — Senator Jon Kyl, who recently left Congress as the second-highest ranking Republican in the U.S. Senate, is joining Covington & Burling’s global public policy and government affairs practice. “Senator Kyl’s deep knowledge and extraordinary legislative skills from his years as a senior leader in Congress make him ideally suited to ...
11/7/2012
WASHINGTON, DC, November 7, 2012 — Covington & Burling received 97 first-tier practice rankings in the 2013 “Best Law Firms” survey by U.S. News-Best Lawyers, placing Covington among the top 10 firms nationwide. Covington was also named “Law Firm of the Year” in both FDA Law and Corporate Compliance Law. The honor is presented to one law firm in each of the ...
November 2012, Regulatory Focus
September 5, 2012
WASHINGTON, DC, September 5, 2012 — Covington & Burling is pleased to announce the addition of Weishi Li as a partner to its corporate team, further bolstering the firm’s global transactional and IP capabilities in the life sciences and technology sectors. Ms. Li will be based in Shanghai when that office opens. Ms. Li’s practice covers a wide range of ...
September 2012, Scrip Regulatory Affairs
August 27, 2012
WASHINGTON, DC, August 27, 2012 — Covington & Burling LLP lawyers received 196 individual mentions in 57 areas of law in the 2013 edition of The Best Lawyers in America. This annual compilation of top U.S. lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as ...
Covington Receives Top Tier Nods in Legal 500 US
August 14, 2012
WASHINGTON, DC, August 14, 2012 — Covington & Burling LLP has received a top tier ranking in six practice areas and 18 individual attorneys are named “Leading Lawyers” in the recently released Legal 500 US 2012 edition. Additionally, Legal 500 US also “recommended” 36 Covington practice areas and 123 Covington lawyers. The six Covington practices given the top ...
July 2, 2012, Covington Advisory
June 29, 2012, Covington Advisory
June 29, 2012, Covington E-Alert
June 15, 2012, Covington Advisory
June 11, 2012
WASHINGTON, DC, June 11, 2012 — Chambers USA recognized 106 individual Covington & Burling lawyers and 46 Covington practice areas in the 2012 Chambers USA: America’s Leading Lawyers for Business guidebook released on June 7, 2012. Many of the 106 Covington lawyers ranked by Chambers USA were recognized in multiple categories, resulting in a total of 131 ...
May 24, 2012
BRUSSELS, 24 May, 2012 — Best Lawyers in Belgium has named Covington & Burling partner Peter Bogaert as the 2012 Brussels “Lawyer of the Year” in the regulatory category for his “abilities, professionalism and integrity.” Best Lawyers recognises one lawyer in each practice area and region. Mr. Bogaert has a broad European life sciences practice. He has detailed ...
May 7, 2012, Covington E-Alert
Covington Lawyers Recognized by D.C. Super Lawyers
May 2, 2012
WASHINGTON, DC, May 2, 2012 — D.C. Super Lawyers selected 64 Covington & Burling lawyers for its 2012 list of top legal talent. Super Lawyers selects no more than five percent of the total lawyers who practice in Washington based on peer review and the publication’s independent research. Deborah Garza and Robert Long have been named among the “Top 100” for ...
February 23, 2012, Bloomberg Law Reports
January 27, 2012
WASHINGTON, DC, January 27, 2012 — Law360 named Covington’s life sciences practice as of one of the top five “Health Practice Groups of the Year,” recognizing its substantial strengths across multiple practices in Asia, Europe and the United States. Covington’s life sciences practice history dates back to the founding of the firm nearly a century ago. The ...
January 3, 2012, Covington E-Alert
December 30, 2011, Covington E-Alert
U.S. News-Best Lawyers Awards Covington ‘Law Firm of the Year’ in FDA Law and 82 First-Tier Practice Rankings
November 1, 2011
WASHINGTON, DC, November 1, 2011 — For the second consecutive year, U.S. News-Best Lawyers awarded Covington & Burling the most first-tier practice rankings for Washington, DC in the “Best Law Firms” survey. The 2011-12 survey also awarded the firm 82 first-tier practice rankings, placing Covington among the top 20 firms nationwide. Additionally, U.S. ...
September 7, 2011
WASHINGTON, DC, September 7, 2011 — Covington & Burling LLP lawyers received 184 individual mentions in 56 areas of law in the 2012 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as follows: ...
September 1, 2011, Covington E-Alert
June 10, 2011
WASHINGTON, DC, June 10, 2011 — Covington & Burling LLP received 123 individual mentions and 45 practice mentions in Chambers USA 2011. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington lawyers and practices ...
June 2011, Bloomberg Health Law Report
Health Care Reform: Federal Court Strikes Down Individual Coverage Mandate; Rest of Law Unaffected
December 13, 2010, Covington E-Alert
December 2010, Covington E-Alert
August 6, 2010
WASHINGTON, DC, August 6, 2010 — Covington & Burling LLP received 138 individual mentions in 40 areas of law in the 2011 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as follows: Administrative: ...
July 26, 2010, Covington E-Alert
June 16, 2010
WASHINGTON, DC, June 16, 2010 — Covington & Burling LLP received 112 individual mentions and 44 practice mentions in Chambers USA 2010. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington lawyers and practices ...
June 2010, Covington E-Alert
Covington Announces Three New Of Counsel
April 30, 2010
<?xml:namespace prefix="o"?><o:p>WASHINGTON, DC, April 30, 2010 — Covington & Burling LLP is pleased to announce the promotion of three lawyers to of counsel.</o:p> <o:p>The new of counsels are as follows:</o:p> <o:p>Natalie Derzko (Washington) practices in the areas of intellectual property, strategic counseling, due diligence, patent prosecution, patent ...
April 29, 2010, Covington E-Alert
April 2010, Covington E-Alert
April 2010, Covington E-Alert
November 6, 2009, Covington E-Alert
September 1, 2009, Covington E-Alert
August 7, 2009
WASHINGTON, DC, August 7, 2009 — Covington & Burling LLP received 131 individual mentions in 38 areas of law in the 2010 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The Covington lawyers recognized are as follows: Administrative: ...
June 12, 2009
WASHINGTON, DC, June 12, 2009 — Covington & Burling LLP received 100 individual mentions and 40 practice mentions in Chambers USA 2009. The guidebook, which ranks lawyers by state and national practice area, is designed to identify the most skilled legal practitioners based on the qualities most valued by clients. Here are the Covington lawyers and practices ...
April 29, 2009, Covington E-Alert
March 20, 2009, Covington E-Alert
February 23, 2009, Covington E-Alert
February 23, 2009, Covington E-Alert
December 18, 2007
NEW YORK, NY, December 18, 2007 — BUPA today announced that it has entered into an agreement to acquire Health Dialog. Covington and Burling LLP represented BUPA, Health Dialog’s largest shareholder, in the $775M transaction, which is expected to close in January. BUPA is a global provider of healthcare services and is the largest private health insurer in the ...
September 6, 2007
WASHINGTON, DC, September 6, 2007 — Covington & Burling LLP received 115 individual mentions in 38 areas of law in the 2008 edition of The Best Lawyers in America. This annual compilation of top US lawyers is based on peer-review surveys and is used as a referral guide in the legal profession. The recipients are as follows: Administrative: E. Edward Bruce and ...
September 5, 2007, Covington E-Alert
August 7, 2007, Covington E-Alert
June 18, 2007
WASHINGTON, DC, June 18, 2007 — Covington & Burling LLP received 44 practice mentions and 74 individual mentions in the newly released 2007 Chambers USA guidebook. The 2007 edition of Chambers USA attempts to identify the most skilled legal practitioners throughout the country based on the qualities most valued by clients. Covington attorneys have been ...
May 3, 2007, Covington E-Alert
January 12, 2007, Covington E-Alert
October 9, 2006, Covington E-Alert
August 24, 2006, Covington E-Alert
June 5, 2006
WASHINGTON, DC, June 5, 2006 - Fifty Covington & Burling lawyers practicing in 27 fields and in each of the firm's US offices were recognized as "leaders in their field" in this year's edition of Chambers USA - America's Leading Business Lawyers. The 2006 edition of Chambers USA, which was released June 2, 2006, attempts to identify the most skilled legal ...
January 19, 2006
WASHINGTON, D.C., January 19, 2006 - Covington & Burling represented AstraZeneca AB in its recent global licensing and research collaboration agreement with Targacept Inc. Under the terms of the agreement, which is subject to the expiration or termination of the HSR (Hart Scott Rodino) clearance period in the US, AstraZeneca will obtain the global rights for ...
Chambers USA Recognizes 29 Covington Lawyers
May 27, 2005
Washington, D.C., June 28, 2005 - Twenty-nine Covington & Burling lawyers practicing in fourteen fields and in each of the firm's U.S. offices were recognized as "leaders in their field" in this year's edition of Chambers USA - America's Leading Business Lawyers. The 2005 edition of Chambers USA, which was released online earlier today, attempts to identify the ...
April 5, 2005, Covington E-Alert
April 4, 2005, Covington E-Alert
February 1, 2005, Covington E-Alert
January 27, 2005, Covington E-Alert
December 2004, Covington E-Alert
December 2004, Covington E-Alert
December 2004, Covington E-Alert
September 17, 2004, Covington E-Alert
August 13, 2004
WASHINGTON, D.C., August 13, 2004 - The United States District Court for the District of Columbia ruled yesterday that a federal statute, enacted in April to protect the nation's graduate medical education system, barred claims of a nationwide antitrust conspiracy to depress the compensation of medical residents. On this basis, Judge Paul L. Friedman dismissed ...
April 14, 2004, Covington E-Alert
December 11, 2003, Covington E-Alert
November 26, 2003, Covington E-Alert
Covington & Burling Announces New Counsel
May 8, 2002
May 8, 2002 - WASHINGTON, NEW YORK, LONDON & SAN FRANCISCO - Covington & Burling has promoted seven attorneys to counsel positions effective April 1, 2002. The new counsel are Dennis B. Auerbach, Wendy L. Feng, Marie A. Lavalleye, John B. Maclay, Lucinda Osborne, Lisa Peets and Elaine W. Stone. Mr. Auerbach is Of Counsel in the Washington office. His ...
- Law360, "Compliance Practice Group of the Year" (2020)
- Law360, "Health Practice Group of the Year" (2011)
- The only firm recognized by Chambers as a “Band 1” firm for Life Sciences across their U.S., UK, Europe, China, and Global surveys.
- Recognized by Chambers USA and Legal 500 US for Healthcare.

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- On the section labeled Use Menu Below to Filter Matters and Results, click the arrow next to Litigation and Investigations under the Practices heading
- On the expanded list, click on Class Actions
- Refreshed information will be displayed under the Representative Matters and News and Insights sections of the page
- To refine the information further, click on Life Sciences under the Industries heading