Our clients – hospitals, pharmacies, clinics, device and drug manufacturers, and insurance and services companies, among others – receive Dorsey’s deep and committed industry knowledge with practical and efficient legal advice. They get the best of both worlds – boutique industry focus with the depth of a large law firm. For life sciences clients we provide comprehensive legal representation throughout the entire product life cycle to companies developing innovative products and services to the biotechnology, pharmaceutical, agri-science, and medical device industries.
If your business operates in the rapidly changing healthcare world, you need more than just legal counsel. You need to stay well ahead – identifying and addressing your company’s risks and opportunities.
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; payors 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 Health Industry Group is keeping true to its promise to stay “Well Ahead” of industry changes.
With leading industry attorneys around the globe, and with our distinctive additional offering of business consulting advice through our consultancy, Dorsey Health Strategies, 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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DORSEY HEALTH STRATEGIES PROVIDES BEST-IN-CLASS BUSINESS CONSULTING TO HEALTH INDUSTRY CLIENTS THAT SPANS THE LIFECYCLE OF YOUR BUSINESS.
Dorsey Health Strategies LLC, a consultancy founded by Dorsey & Whitney LLP, offers a comprehensive array of business advisory and regulatory services to clients in the health industry. Our consulting services range from strategic planning to operational assistance to optimizing business models, and these services may be obtained in conjunction with Dorsey’s legal services or independently.
Clients turn to us when they need to understand and navigate the web of highly-technical and often counter-intuitive set of 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.
A privacy or security breach is among the most feared risks 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.
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, medical device and pharmaceutical reimbursement matters. We often are called 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 benefit 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, specialty, and safetynet pharmacies; distributors; pharmacy benefits managers, both large and small; and pharmacy-related operations such as pharmacy networks and drug donation depositories navigate the complex web of federal and state statutes and regulations governing their operations. 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
Fraud and Abuse
- On behalf of one of the country’s largest health insurers, interacted with governmental agencies on over 30 fraud and abuse matters.
- Represented hospital system in defending Department of Justice allegations of billing fraud, resulting in no claims or action taken.
- Regularly guide healthcare providers through the OIG self-disclosure process arising from Medicare billing issues, recruitment arrangements, Stark violations involving lease arrangements and physician recruitment arrangements, and the hiring of individuals excluded from federal healthcare programs.
- Represented pharmaceutical manufacturers in settlement agreements with the Department of Justice involving anti-kickback allegations.
- Represented national chain pharmacy in renegotiation of drug wholesaler contract.
- Updated the compliance program for a national pharmacy chain.
- Represented a tax exempt healthcare system in formation of joint venture, negotiation of professional services agreement and management agreement with for profit retail pharmacy to operate retail clinic staffed with advanced practice nurse professionals provided by healthcare system.
- Created a corporate and contracting structure for ExceleraRx Corp., a national network of health system-based specialty pharmacies.
- Represented a healthcare system in the Pacific Northwest to create a joint venture with a national retail pharmacy to open walk-in clinics staffed by advanced practice providers.
- Represented Target Corporation as pharmacy counsel in the sale of its pharmacy assets to CVS Pharmacy, Inc.
- Represented Geneva Woods Pharmacy, Inc. as corporate counsel and in multiple acquisitions in Wyoming, Washington, Idaho and Alaska, including 363 and receivership purchases.
- Represented PBMs in lawsuits alleging violations of ERISA.
Privacy & Security
- A large nationwide health plan client turned to Dorsey to handle the amendment of hundreds of business associate agreements following the enactment of the HITECH Act.
- Dorsey has represented healthcare providers and health plans in connection with investigations under HIPAA conducted by the Department of Health and Human Services – Office of Civil Rights.
- Dorsey regularly assists clients with drafting website policies that are HIPAA-compliant.
- Represent covered entities and business associates in assessing and addressing breach incidents and investigations and the class action lawsuits that often follow.
- Created a corporate and contracting structure for ExceleraRx Corp. a national network of health system-based specialty pharmacies.
- Represented multi-specialty physician group in development and opertion of a joint-venture hospital.
- Represented national chain pharmacy in renegotiation of drug wholesaler contract.
- Lead health counsel for OptumHealth Care Solutions, Inc. in its acquisition of OrthoNet Holdings, Inc.
- Lead health counsel for Collaborative Care Holdings, LLC in its acquisitions of ProHEALTH Medical Management, LLC and WESTMED Practice Partners LLC.
- Lead health counsel to United HealthCare Services, Inc. in its acquisition of the rights to renew certain commercial administrative services business and health insurance membership in the States of Georgia, Indiana and South Carolina.
- Represented tax exempt healthcare system in Northwest in formation of joint venture, negotiation of professional services agreement and management agreement with for profit retail pharmacy to operate retail clinic staffed with advanced practice nurse professionals provided by healthcare system.
- Represented numerous multi-hospital healthcare systems on joint ventures with physicians related to diagnostic imaging and ambulatory surgery centers.
- Represent multi-hospital healthcare system in the formation of a joint venture with physical therapy providers.
- Represented a Midwest hospital system and a Northwest hospital system to create a cardiovascular service line “institute” in Midwest and Northwest providing professional services and management services for hospital’s cardiovascular service line.
- Represented healthcare system in Northwest to create a joint venture with a national retail pharmacy to open walk-in clinics staffed by advanced practice providers.
- Represent numerous healthcare systems to obtain fair market value support for utilization reviews, call coverage, acquisitions, joint ventures and other integration strategies.
- Represented a leading provider of rehabilitation management services located in the South to structure relationships with advanced practice providers to comply with fraud and abuse, corporate practice of medicine and scope of practice and supervision requirements in many states.
Health Information Technology
- Represented a leading provider of medical equipment management and service solutions to the US healthcare industry in the negotiation of the purchase of a payroll and HR software-as-a-service tool.
- Successfully resolved two meaningful use audits.
- Represented a large Minnesota-based public company in connection with the drafting and negotiation of a master services agreement (including software-as-a-service for certain tools used in the services) for the implementation, delivery and transition of use of business process outsourcing services by its healthcare provider customer.
- On behalf of first-of-its-kind state health information exchange, negotiated master service and license agreement and statements of work for setting up the a hosted exchange with a major software vendor, and general representation of exchange in consulting services agreements and additional licensing for add on features.
- Represented multiple providers in Iowa in connection with the implementation of their electronic health records systems and ancillary agreements with a variety of electronic health record vendors, including Meditech, LSS, Epic, McKesson, and DrFirst.
- Represent US manufacturers of implantable cardiac products in international product distribution, license, joint development of intellectual property and regulatory matters.
Industries & Practices
- Antitrust & Competition Law
- Benefits & Compensation
- ERISA Litigation
- Government Enforcement & Corporate Investigations
- Health Litigation
- Health Transactions & Regulations
- Mergers & Acquisitions
- Non-Profit & Tax Exempt Organizations
- Public Finance