well ahead

Technology is quickly changing the way healthcare is delivered and recorded and paid for. Large employers in all industries are adding telemedicine/virtual care visits to their wellness plans; payers and PBMs are partnering with data analytics companies; providers who have implemented EHRs are now adding additional digital services; and technology companies in non-health industries are looking to pivot into offering healthcare technology services – and digital health specifically. As the digital health industry picks up speed, Dorsey’s Healthcare Industry Group is keeping true to its promise to stay “Well Ahead” of industry changes.

With leading industry attorneys around the globe, Dorsey is uniquely positioned to assist in all aspects of the legal, regulatory, and business issues that arise from the use of technology to deliver and improve healthcare and wellness. Our Digital Health experts work closely with our Privacy, FDA, Intellectual Property, Benefits, Licensing, Corporate, Private Equity and Litigation attorneys to deliver practical solutions.

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We advise manufacturers and developers of biotechnology, medical device, drug, cell and tissue-based products, as well as entities involved in clinical trials. We can assist clients along the entire life cycle of their products: investigation, clinical studies, marketing applications, the intersection of FDA and patent law, and post-market regulation. We have also helped laboratory companies submit CLIA waiver applications, develop comprehensive corporate compliance plans, and structure their operations to comply with the rules regarding proficiency testing, among other matters.

Our clients need quick and practical answers to complex benefits and compensation questions. We advise employers, large and small, on how to navigate the increasingly complex and regulated employee benefits field. That includes HIPAA, healthcare, privacy, and executive compensation in addition to traditional tax-qualified retirement and pension plans. 

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Clients turn to us when they need to understand and navigate the web of highly-technical, and often counter-intuitive, healthcare fraud and abuse rules. We help healthcare providers, manufacturers and insurers to:

• Advise on structuring business transactions to ensure compliance with Stark, anti-kickback, Medicare and Medicaid reimbursement rules, and other healthcare fraud and abuse rules,
• Provide day-to-day business operations analysis regarding fraud and abuse,
• Conduct internal fraud and abuse investigations,
• Handle self-disclosures to OIG and other agencies regarding fraud and abuse issues,
• Represent clients in federal or state fraud and abuse and false claims investigations and lawsuits,
• Represent providers in RAC, ZPIC, and other post-payment audits, and
• Draft, revise, and implement compliance programs.

Hospitals and other healthcare entities rely on Dorsey’s Healthcare Industry Group to provide advice and counsel related to their financings. Dorsey acts as bond counsel, corporate counsel and/or underwriters counsel for a wide range of healthcare financings around the country. We also help hospitals and health systems navigate the ever-expanding and complex securities and IRS disclosures necessary for healthcare financings to ensure compliance throughout the financing process and beyond.

In the healthcare industry, litigation is at best a costly distraction and at worst a grave threat. Even in the smallest dispute, reputations are at stake. That’s why healthcare entities across the country turn to Dorsey for their most important litigation. With extensive industry experience and tested litigation skills, we bring an informed perspective to healthcare disputes.

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A privacy or security breach is among the most feared risk facing any healthcare business. The cost of breach notification obligations, the follow-on HHS investigation and potential penalties and class-action lawsuits combine to make privacy and security issues in today’s world among the most expensive and damaging of legal risks. We provide extensive counsel on HIPAA privacy matters for hospitals, physician groups, health systems, specialty boards, healthcare clearinghouses and healthcare system networks, and many of our lawyers specializing in privacy are certified information privacy professionals. Our healthcare privacy and security practice complements our Privacy and Social Media group with healthcare-specific expertise, and will help you avoid these types of incidents and minimize their impact if they occur.

We work with clients across the healthcare industry, including hospitals, health systems, retirement communities, nursing homes, physician practices, retail and specialty pharmacies, payers of healthcare services and medical device, technology and pharmaceutical companies. 

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Dorsey’s 50 years of success and experience in intellectual property litigation has consistently earned our team national recognition. Whether through litigation in the courts or challenges at the patent office, we partner with our clients to find creative solutions for their intellectual property issues at a reasonable cost.

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Dorsey has served clients in the healthcare industry since the 1940s, with clients ranging from the largest healthcare payer in the United States, to one of the world’s most recognizable medical practices, to companies and investors at the forefront of medical innovation. Medical technology companies rely on Dorsey because our attorneys understand the legal and technical issues crucial to success in this rapidly changing industry. Our wide range of expertise and experience, which includes attorneys with scientific/engineering degrees and industry backgrounds, including Ph.D.’s, provides a framework for our clients' success.

Focus on Medical Technology:

• AI/Machine Learning/Bioinformatics
• Biosensors
• Biomaterials
  • Superelastic alloys
  • Shape memory alloys
• Cardiovascular Devices
  • Cardiac Rhythm Management
  • Coronary
  • Electrophysiology Mapping
  • Structural Heart
• Dermatology
• Drug delivery
• Digital Health and Electronic Health Records
• Endoscopy/Laparoscopy
• Gastroenterology
• Gynecology
• Hematology
• Imaging, including MR/Ultrasound/OCT
• Implant and tissue sterilization
• Minimally invasive access/surgical systems
• Microfluidics/Lab-on-a-chip devices
• Neurology
  • Neuromodulation
  • Neurointerventional systems
• Otolaryngology
• Ophthalmology, including IOLs and stents
• Orthopedics
• Osteobiologic materials and implants
• Pulmonology
• Radiotherapy
• Robotics
• Spine
• Urology
• Wound care

Patent Services we provide to our Medical Technology Clients:

• Patent prosecution, opinions, and litigation support for one of the world’s largest medical device companies in the external and invasive catheter technology area.
• Patent prosecution, opinions, and litigation support for medical device companies in the cardiovascular and cardiology device technology area.
• Patent prosecution and opinions for a fortune 100 medical device company in the puncture closure technology area.
• Patent prosecution and opinions related to injection and infusion devices, osteobiologics and orthobiologics, endovascular, urology, dermatology, otolaryngology (ENT), pulmonology, spine, orthopedics, cardiology, neurology, ophthalmology, gastroenterology, women’s health, robotic surgery, obesity, orthodontics, orthopedics, including sensing and ablating with RF and lasers.
• Represent numerous start-up medical device companies in the U.S. and abroad, such as companies in the arterial and venous pump technology area.
• Developing and executing prosecution strategies—not only to protect a client's products, but also to analyze those of its competitors—to help ensure that the client realizes value from its intellectual property assets
• Preparing and negotiating licenses, assessing the licensing value of competitors' patents, and guiding the client in the decision to license.
• Monitoring the field to know when a client needs a clearance opinion or has a potential interference issue. These efforts can help direct the client in research and development areas that minimize patent obstacles.
• Providing counsel on business-related matters, including antitrust and competition issues, and FDA regulatory issues.
• Advising on potential litigation strategies and, when necessary, deploying experienced trial teams.
• Performed patent due diligence for medtech and life science venture funds.

Dorsey provides experienced healthcare reimbursement counsel involving Medicare, Medicaid, and other payers of healthcare items and services. For decades, healthcare providers, manufacturers and payers have turned to us for counsel in this area. Our expertise in the healthcare reimbursement arena stems from our long-standing knowledge of the healthcare industry and its ever-changing and complex regulatory and reimbursement environment.

We furnish specialized counsel to many providers, medical device manufacturers, pharmaceutical manufacturers, and others on complex matters involving Medicare and Medicaid reimbursement, including coverage issues, clinical trial reimbursement, Medicare enrollment and Change of Ownership rules, Medicare provider-based rules, medical necessity rules, imaging reimbursement and anti-mark-up rules, federal “Stark” compliance, physician and non-physician practitioner reimbursement, corporate practice of medicine, and many others.

Our experience includes hospital inpatient and outpatient reimbursement rules, as well as detailed knowledge of physician service reimbursement, and medical device and pharmaceutical reimbursement matters. We often are called on to handle matters directly with the relevant regulatory agency, including the Centers for Medicare and Medicaid Services (“CMS”), local Medicare Administrative Contractors, the Department of Health and Human Services Office of Inspector General (“OIG”), and State Medicaid agencies. We can help your business respond and appeal reimbursement denials, 340B audits, “meaningful use” audits, post-payment audits (e.g., RAC, PSC, or ZPIC audits), and others.

All players across the pharmacy continuum, including pharmacies, wholesalers, manufacturers and pharmacy benefits managers (PBMs) are among the most highly regulated businesses in the United States, and the consequences of regulatory non-compliance can be serious and expensive. At the same time, the pharmacy industry has seen a great deal of structural change through joint ventures, mergers, acquisitions and other affiliations with opportunities for consolidation, collaboration and new models of service delivery.  Dorsey’s Healthcare Industry Group assists these entities in both contexts. The group includes a team of health lawyers with experience assisting pharmacies, including retail, mail order, online, specialty, and safetynet pharmacies; distributors; pharmacy benefits managers, both large and small; and pharmacy-related operations such as pharmacy networks and drug donation depositories. We have advised dozens of pharmacies and PBMs in legal matters including:

• Creation of Policies and Procedures 
• Compliance Programs
• VAWD and URAC Accreditation 
• OIG and DEA Investigations 
• PBM and Payer Audits 
• Anti-Kickback and Inducement Issues
• Downstream Entity Obligations, including Fraud, Waste and Abuse Issues
• Retail Rewards and Loyalty Programs 
• Licensing and Credentialing 
• State Inspections and Investigations
• Big Data and Analytics  
• Acquisitions and Corporate Transactions 
• Contractual Arrangements and Negotiations
• DEA and Diversion Issues 
• HIPAA Training
• Privacy Laws and Privacy Breach Investigations and Responses 
• 340B Drug Pricing Issues and Compliance 
• Reimbursement Matters
• Medicare and Medicaid 
• Telepharmacy Issues 
• Formation, Restructuring and new Affiliation Issues
• Vendor Contracts
• Pre-Litigation and Litigation Support