Health Care

August 11, 2020, Covington Digital Health

Software development can teach us a lot about streamlining the research and development (R&D) process in other industries.  “Agile development”, or the process of dividing up an R&D project into smaller, more iterative segments instead of planning the entire project at its inception, is a hallmark of the software development process.  In a recently published...… ...

August 11, 2020, Covington Digital Health

On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is expected to enter into force in autumn 2020. One of the main objectives of the bill is...… Continue ...

July 30, 2020, Covington Digital Health

Public-health researchers, officials and medical professionals rely on data to track outbreaks, advance research, and evaluate prospective treatments. One critical source of patient data comes from electronic health records (EHRs).  EHR data in the U.S. has traditionally been siloed within hospital IT systems, but the federal government and key healthcare ...

July 23, 2020, Covington Digital Health

On July 13, 2020, the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising the Confidentiality of Substance Use Disorder Patient Records regulations located at 42 C.F.R. Part 2, commonly referred to as “Part 2.”  Under Part 2, federally assisted substance use disorder ...

July 7, 2020, Covington Digital Health

On June 4, 2020, Representatives Anna Eshoo (D-CA-18), Anthony Gonzalez (R-OH-16), and Mikie Sherrill (D-NJ-11) introduced the National AI Research Resource Task Force Act.  This bipartisan bill would create a task force to propose a roadmap for developing and sustaining a national research cloud for AI.  The cloud would help provide researchers with access to ...

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 ...

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 ...

June 4, 2020, Covington Digital Health

Senators Maria Cantwell (D-WA) and Bill Cassidy (R-LA) introduced bipartisan legislation this week to address privacy issues in the COVID-19 era.  The proposal, entitled the “Exposure Notification Privacy Act,” would regulate “automated exposure notification services” developed to respond to COVID-19.  This bipartisan legislation comes on the heels of dueling ...

June 2, 2020, Covington Digital Health

On May 28, the White House Office of Science and Technology Policy (OSTP) hosted a meeting of the G7 Science & Technology (S&T) Ministers to collaborate on COVID-19 response and recovery.  The G7 S&T Ministers emerged from the meeting with a declaration, in which they expressed their intent to: Enhance cooperation on shared COVID-19 research...… Continue Reading

May 20, 2020, Covington Digital Health

Artificial Intelligence (AI) has played an important role in battling COVID-19 since the initial outbreak: HealthMap – an AI tool from Boston Children’s Hospital that scans news reports, social media, and other data for signs of disease outbreaks – first sounded the international alarm after picking up reports of an emerging virus in Wuhan, China....… Continue ...

May 15, 2020, Covington Digital Health

The following guidance could be relevant to manufacturers of software as a medical device (SaMD).  The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent ...

May 15, 2020, Covington Digital Health

On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”).  The request for comment is part of a periodic review process “to ensure that [FTC rules] are keeping pace with changes in the economy, technology, and...… Continue Reading

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 ...

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

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 ...

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 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 ...

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.

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, ...

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, ...

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.”

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 ...

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 ...

2019, Global Legal Insights to: Pricing & Reimbursement 2019

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 ...

2018, Global Legal Insights to: Global Legal Insights - Pricing & Reimbursement 2018, 1st Ed.

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 ...

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 ...

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 ...

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 ...

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. 

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 ...

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 ...

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, ...

April 11, 2017, Law360

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 ...

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.

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 ...

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 ...

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

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 ...

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 ...

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 ...

February 2020

Since the beginning of the Brexit process more than three years ago, Covington’s Brexit Task Force–comprised of over 40 lawyers and former senior diplomats and policymakers, in London, Brussels, Frankfurt, Dublin, and Washington–has been advising clients in a wide range of industries on the challenges and opportunities created by this historic event. While a ...

July 2016, eHealth Law & Policy

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 ...

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 ...

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 ...

May 2016, eHealth Law & Policy

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 ...

October 29, 2015, Covington Alert

October 7, 2015, Covington Alert

August 2015, An Extract from The European Antitrust Review 2016

July 13, 2015, BNA’s Health Care Policy Report

June 23, 2015, Law360

May 13, 2015, Life Sciences Essentials Webinar Series

May 4, 2015, Covington E-Alert

April 13, 2015, BNA’s Health Care Policy Report

April 7, 2015, Covington E-Alert

March 9, 2015, The National Law Journal

December 23, 2014, Covington E-Alert

October 27, 2014, Covington E-Alert

October 17, 2014, Law360

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), ...

September 26, 2014, Law360

September 9, 2014, Covington E-Alert

July 30, 2014, Bloomberg

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 ...

February 19, 2014, Law360

January 10, 2014, Covington E-Alert

December 31, 2013, Covington E-Alert

November 8, 2013, Covington E-Alert

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 30, 2013, Covington E-Alert

July 26, 2013, Covington E-Alert

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 ...

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 ...

February 21, 2013, Covington E-Alert

February 13, 2013, Covington E-Alert

February 7, 2013, Covington Advisory

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 ...

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 20, 2012, Law360

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

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 20, 2012, Covington E-Alert

January 3, 2012, Covington E-Alert

December 30, 2011, Covington E-Alert

December 23, 2011, Covington E-Alert

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

April 15, 2011, Covington E-Alert

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: ...

August 3, 2010, Covington E-Alert

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 3, 2010, Covington E-Alert

June 2010, Covington E-Alert

May 3, 2010, Covington E-Alert

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 12, 2010, Covington E-Alert

April 2010, Covington E-Alert

April 2010, Covington E-Alert

April 2010, Covington E-Alert

April 2010, Covington E-Alert

April 2010, Covington E-Alert

November 9, 2009, 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

April 29, 2009, Covington E-Alert

March 20, 2009, Covington E-Alert

February 23, 2009, Covington E-Alert

February 23, 2009, Covington E-Alert

September 2008, 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

August 6, 2007, Covington E-Alert

July 17, 2007, Health Law 360

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

January 11, 2007, Covington E-Alert

January 2007, Covington E-Alert

January 2007, Covington E-Alert

January 2007, Covington E-Alert

October 9, 2006, Covington E-Alert

October 4, 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 ...

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

January 2005, Covington E-Alert

December 2004, Covington E-Alert

December 2004, Covington E-Alert

December 2004, Covington E-Alert

December 2004, Covington E-Alert

October 2004, Covington E-Alert

September 17, 2004, Covington E-Alert

August 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

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 ...