Recent News:
Cozen O'Connor successfully represented Apotex at the U.S. Court of Appeals for the Federal Circuit in securing a denial of Vanda Pharmaceuticals' bid to seek an injunction pending an appeal of Apotex's and Teva's victory in the District of Delaware.
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Health care and life sciences is inarguably one of the largest, most heavily regulated, and fastest-growing industries in the U.S. economy. It is also utterly unique. Health care and life sciences companies do not function simply to maximize returns, and the standard economic forces of supply and demand do not apply. Ultimately, every player in this market—whether a hospital, biotechnology company, nursing home, or medical equipment manufacturer—is responsible for helping people lead longer and healthier lives.
To be effective, advocates for the health care and life sciences industry must integrate an awareness of and commitment to this underlying responsibility into every element of their work. The members of Cozen O’Connor’s health care and life sciences industry team understand this social mission as well as its legal, political, macroeconomic and business consequences for our clients. Attorneys at the firm have been providing excellent counsel to health care and life science companies for decades.
Our client base includes a diverse array of companies. In the health care sector, we serve leading pharmaceutical companies, hospitals, health care systems, medical equipment manufacturers and suppliers, assisted living facilities, academic institutions, insurers and physician groups. In the life sciences sector, we serve drug developers, biotechnology companies, medical device manufacturers and cutting-edge startups.
For health care and life sciences clients, it is essential that their attorneys have deep industry knowledge. Good commercial litigators or corporate lawyers can serve a chain of shoe stores just as capably as a chain of pizza parlors, but that does not mean they can serve a chain of hospitals. The health and life sciences field is so heavily regulated that all legal work in this arena must be grounded in a specific and sophisticated understanding of health laws. At Cozen O’Connor, we have litigators, transactional lawyers and corporate counselors who are both leaders in their legal disciplines and masters of this complex and ever-changing statutory regime.
SERVICE AREAS
Litigation
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Handle third-party payer litigation and reimbursement proceedings
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Represent clients in fraud, abuse, Stark Law and False Claims Act cases
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Conduct internal investigations and respond to enforcement acts by federal and state agencies
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Represent health care and life sciences companies in intellectual property, employment, antitrust and other commercial litigation
Transactional
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Arrange mergers, acquisitions, consolidations, divestitures, workouts and restructurings
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Negotiate joint ventures, alliances and co-management arrangements
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Resolve antitrust, tax and bankruptcy issues for health care and life sciences organizations
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Arrange financings through public offerings, bonds, loans and other investment vehicles
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Conduct major real estate deals for industry clients
Regulatory
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Advise on privacy, confidentiality, HIPAA compliance and safety laws
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Handle Medicare, Medicaid and other third-party reimbursement matters
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Develop and assess regulatory compliance programs for health care and life science clients
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Counsel clients on employee benefits, credentialing and executive compensation strategies
RELATED PRACTICES
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Health Law
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Labor & Employment
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Employee Benefits & Executive Compensation
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Antitrust
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Real Estate
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Public & Project Finance
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Intellectual Property
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Product Liability
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Cozen O’Connor Public Strategies, LLC
October 27, 2022
Health care entities, home health care agencies, and staffing registries considering a transaction in New Jersey will need to keep in mind new obligations to certain employees. On August 18, 2022, Governor Murphy signed into law New Jersey Senate Bill No. 315 (the “Act”), which created broad...
October 14, 2022
We previously reported that the Fourth Circuit, via a 2-1 decision in United States ex rel. Sheldon v. Allergan Sales, LLC, 24 F.4th 340 (4th Cir. 2022), affirmed the dismissal of a False Claims Act (“FCA”) qui tam lawsuit against Forest Laboratories, LLC (“Forest”). The plaintiff alleged that...
October 06, 2022
In a continuing wave of fraud and abuse civil enforcement actions brought by qui tam relators, big pharma giant, Biogen, is the latest corporate actor to reach a mega settlement with the U.S. Department of Justice (DOJ) for allegations of False Claims Act liability for paying bribes to physicians...
September 27, 2022
The Office of Civil Rights of the Department of Health and Human Services (“OCR”) announced the resolution of three more right of access cases, bringing the total to a whopping 41 since the start of its drive to increase compliance with this Health Insurance Portability and Accountability Act...
September 23, 2022
In its recently published Special Fraud Alert, the Office of Inspector General (“OIG”) presented a list of suspect characteristics related to arrangements with telehealth and telemedicine companies, which may help determine the potential for fraud.
The OIG developed this list based on dozens of...
September 14, 2022
On August 19, 2022, the United States Departments of Health and Human Services, Labor and Treasury released final rules (“Final Rules”) revising certain provisions of their previously issued interim final rules regarding the No Surprises Act (“NSA”).
The revisions reflect some comments received...
July 01, 2022
Patient privacy concerns are at an all-time high following the Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization. Following their statements affirming that abortion constitutes basic and essential health to which every woman should be entitled issued by both Xavier Becerra,...
April 06, 2022
CMS continued to roll out guidance regarding the No Surprises Act. The latest guidance is the second set of FAQs regarding the Good Faith Estimate Requirement for uninsured and self-pay patients was issued on April 5, 2022. The FAQs address six questions regarding the requirement and can be found...
March 30, 2022
On February 23, 2022, the U.S. District Court for the Eastern District of Texas gutted portions of the interim final rule affecting the independent dispute resolution (“IDR”) process of the No Surprises Act (the “Act”). Tex. Med. Ass’n v. U.S. Dep’t of Health & Human Servs., No....
March 09, 2022
A few weeks ago, the U.S. Court of Appeals for the Fourth Circuit answered a critical inquiry in the False Claims Act (“FCA”) context: does a defendant violate the FCA when its reading of the regulation is objectively reasonable and there is no government guidance discouraging or rejecting that...
October 05, 2021
On Thursday, September 30, 2021, The United States departments of Health and Human Services (“HHS”), Labor and Treasury released an interim final rule (“Rule”) that completes most of the regulatory framework under the federal No Surprises Act (“Act”). The Act largely bars balance billing of...
August 12, 2021
Two chambers of commerce, the Chamber of Commerce the United States of America and the Tyler (TX) Area Chamber of Commerce, filed a lawsuit on August 10, 2021, in the US District Court for the Eastern District of Texas against the United States departments of Health and Human Services, Labor and...
July 02, 2021
The United States Departments of Health and Human Services, Treasury and Labor released interim final rules (“Rules”) regarding the “No Surprises Act” (“Act”) yesterday. The Rules are effective beginning on January 1, 2022. They cover the requirements for the billing and payment of emergency and...
December 29, 2020
On December 28, 2020, the District Court for the Northern
District of California granted a motion for a preliminary injunction enjoining
the Centers for Medicare and Medicaid Services from implementing the Most
Favored Nation Rule (the “Rule”, summarized in our December
23 post) until the notice...
December 23, 2020
On December 23, 2020, The District Court for the District of
Maryland granted a temporary restraining order temporarily ceasing the
implementation of the Centers for Medicare and Medicaid Services’ (“CMS”) Most
Favored Nations Rule (the “Rule”) for fourteen (14) days. The Rule,
published on...
November 23, 2020
On Friday, November 20, 2020, the Centers for Medicare and
Medicaid Services (“CMS”) released final regulations to remove certain barriers
to the implementation of physician compensation arrangements under value-based
payment arrangements posed by the “Stark” Physician Self-Referral law. The...
November 06, 2020
On October 29, 2020, Governor Wolf signed House Bill 81 into law, creating new minimum education and certification requirements for central service technicians and surgical technicians working in the Commonwealth, and regulating the practice of surgical technology. The Act will take effect on...
October 28, 2020
Alex Campau, Mark Alderman, and Brett Banker discuss the similarities and differences between Trump and Biden's health care policies.
May 15, 2020
Danielle Sapega discusses the Pennsylvania attorney general's investigation into nursing homes, the Department of Health's guidance for nursing homes, and the governor's executive order granting immunity to health care workers.
May 08, 2020
Adam Schlatner and Michael de Leeuw discuss potential COVID-19 related litigation, based on what is already happening and the legacy of other downturns.
April 29, 2020
J. Nicole Martin and Gregory M. Fliszar discuss CMS's blanket waivers for nursing facilities and skilled-nursing facilities effective through the end of the COVID-19-related emergency.
April 29, 2020
Gregory M. Fliszar discusses what measures Pennsylvania hospitals must take before resuming elective surgeries and procedures.
April 20, 2020
Danielle E. Sapega and Gregory M. Fliszar discuss CMS's new guidance for nursing homes when it comes to reporting confirmed or suspected cases of COVID-19.
April 20, 2020
J. Nicole Martin and Gregory M. Fliszar discuss CMS's guidance for health care systems in areas with low COVID-19 infections to reopen nonessential care.
April 09, 2020
Gregory M. Fliszar discusses CMS's announcement that $30 billion will be distributed from the health care provider relief fund in the CARES Act.
March 27, 2020
Robert K. Magovern and Matthew Howell discuss the DOJ's and FTC's joint statement pertaining to the enforcement of competition laws during the COVID-19 pandemic.
March 13, 2020
Gregory M. Fliszar and Danielle Sapega discuss the HIPAA Privacy and Novel Coronavirus bulletin and what providers and covered entities need to know during a public health emergency.
June 05, 2019
Peter Ennis discusses HHS's new conscientious objector rule and what health care providers need to do in order to prepare for compliance.
June 20, 2018
Bobbi Britton Tucker discusses the court's decision in Marie Gillispie v. Regionalcare Hospital Partners, Inc., and how the court rules that the EMTALA’s whistleblower provision protects employees who inform personnel in a covered facility of an alleged EMTALA violation, even though the employee does not also inform any governmental or regulatory agency.
January 03, 2023
Cozen O'Connor successfully represented Apotex at the U.S. Court of Appeals for the Federal Circuit in securing a denial of Vanda Pharmaceuticals' bid to seek an injunction pending an appeal of Apotex's and Teva's victory in the District of Delaware.
December 13, 2022
Cozen O’Connor scored a major win for Apotex Inc. and Apotex Corp. in federal court in Delaware.
July 01, 2022
The American Bar Association (ABA) has appointed Gregory Fliszar and Aselle Kurmanova to leadership positions in their Health Law and Business Law sections.
November 08, 2021
James will advise the firm’s health care clients in connection with litigation matters arising from provider-payor disputes, False Claims Act matters, private equity transactions, and merger activity, in addition to other complex commercial litigation issues.
September 22, 2021
Buck brings an impressive resume with over two decades of experience in the life sciences intellectual property sector.
May 18, 2021
Kurmanova joins the firm from Seyfarth Shaw LLP, reuniting with John Shire, who joined the firm in November 2020.
May 17, 2021
Jeff will join as a shareholder in the Minneapolis office.
March 01, 2021
Jonathan Grossman was featured in an article published by Healthcare Dive discussing four health care antitrust issues to watch.
November 02, 2020
Shire brings a deep understanding of federal and state health care regulations and has been instrumental in several of the most well-known transactions in the health care space.
June 05, 2020
Super Lawyers has selected 58 Cozen O'Connor attorneys to the 2020 Pennsylvania Super Lawyers and Rising Stars lists.
June 13, 2019
Alex Campau discussed with The Wall Street Journal about how employees will now be able to use HRAs to buy individual coverage, with certain restrictions, starting January 2020.
March 28, 2019
John Sullivan was quoted in Law360's recent article on the U.S. Food and Drug Administration's recent safety alert last week about the vulnerability to hacking of up to 750,000 implantable heart defibrillators.
December 20, 2018
Alex Campau, Principal & Director of Health Policy, shares her predictions about the key health policy trends she anticipates taking center stage in 2019 with Morning Consult.
August 22, 2018
Alex Campau, a member of Cozen O'Connor's Public Strategies group, spoke with Law360 about her experience at the White House.
August 06, 2018
Campau is a major add to the Firm’s Government Relations Practice in Washington, D.C.
March 27, 2018
Former LeClairRyan attorney Jeffrey N. Townes brings substantial experience in international life sciences IP to the firm's Washington, D.C., office.