Healthcare
Comprehensive legal solutions for the healthcare industry's diverse needs.
Our Healthcare industry group serves clients across a full spectrum of the healthcare landscape.
This encompasses hospitals, academic medical centers, clinical laboratories, pathology practices, physician groups, pharmacies, imaging centers, medical device and supply companies, long-term care facilities, behavioral health providers, medical suppliers, and individual healthcare professionals.
How we help clients
- Audit Defense and Reimbursement
- Compliance and White Collar Defense
- Corporate Structuring and Transactions
- Privacy and Data Security
- Finance
- General Counsel Services
- Healthcare Reform
- Intellectual Property
- Labor and Employment
- Licensing and Technology
- Real Estate and Land Use
- Restructuring and Bankruptcy
Our Team
Areas of counsel include:
Audit Defense and Reimbursement
We collaborate with our healthcare provider clients to safeguard their full compensation for the care they provide. Our defense extends to audits by government and commercial payors, and we litigate federally and at state levels to prevent reductions in Medicare, Medicaid, and TRICARE payments.
Compliance and White Collar Defense
Our legal practitioners lead our clients through the complexities of compliance and regulatory challenges, especially amidst the ever-shifting landscape of healthcare industry policy. We provide counsel on corporate compliance programs and ardently defend clients embroiled in criminal or civil investigations and prosecutions.
Our team is comprised of healthcare regulatory professionals, including a former U.S. Attorney and several former state and federal prosecutors, each with a wealth of experience in healthcare-related matters. We bring to the table the depth of experience and familiarity with the intricate web of laws and regulations governing the industry, including but not limited to Medicare/Medicaid fraud, government investigations, False Claims Act claims, EMTALA, antitrust, and corporate compliance.
Corporate Structuring and Transactions
For our clients in the healthcare industry, our team of skilled attorneys focuses on corporate structuring and transactions, ranging from mergers and acquisitions to joint ventures and affiliations among tax-exempt entities, private equity and venture capital financings, and public securities offerings. We provide comprehensive advice on a myriad of areas, including corporate transactions, tax matters (including the ever-important 501(r) requirements and community health needs assessments), antitrust considerations, technology licensing and transfer, payer certification, trade secret protection, due diligence and employment matters, all the while upholding the highest standards of corporate governance.
Privacy and Data Security
We assist clients in the development of robust confidentiality, privilege, and data security policies and programs essential for compliance with the dynamic landscape of federal and state regulations. These include the stringent data security and privacy mandates within the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH), the Privacy Act, as well as peer review laws and facility accreditation standards. We also help innovative companies understand and comply with the laws governing biometric data and biometric technologies. We have advised clients regarding data security and breach response and assist clients to better prepare them for network attacks and intrusions and from lawsuits and regulatory inquiries.
Finance
Within our finance practice, we represent hospitals and healthcare facilities as borrowers, strategically leveraging the variety of tax regulations in tax-exempt bond transactions to their advantage. These regulations offer opportunities for improved debt management. With a track record of representing tax-exempt borrowers across more than 25 states, including the District of Columbia and Puerto Rico, our expertise in IRS regulations is a distinct asset, enhancing both the financial and operational flexibility of our institutional provider clients.
By meticulously structuring transactions to isolate bond proceeds and further heightening the reimbursement component, we create an avenue for future flexibility in facility use. This, in turn, reduces the compliance monitoring burden. We remain vigilant on matters of charitable trust, examining financial support, cross-jurisdictional transfers, and the ramifications of asset transactions, mergers, and consolidations.
Our work extends to advising financial institutions that provide liquidity and/or credit enhancement for tax-exempt bonds. We have also taken on roles as bond counsel and underwriters' counsel for tax-exempt healthcare bond offerings across the United States.
General Counsel Services
Our legal representation for hospitals and healthcare establishments includes the full spectrum of outside general counsel services. We offer strategic advice for the myriad of operational challenges faced by the healthcare industry each day, as well as guidance in the complex web of transactions and contractual arrangements, such as managed care agreements. Our legal team is equipped to assist in the development of policies and procedures, as well as provide knowledgeable counsel on the many laws and regulations that impact the healthcare industry—from HIPAA to HITECH, and from Stark to Anti-Kickback laws.
Healthcare Reform
Our attorneys have been counseling healthcare industry clients on the opportunities and challenges arising from the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act since their enactment in March 2010.
Intellectual Property
Our tailored range of intellectual property services for the healthcare sector, life sciences, and technology markets is designed to address the unique challenges faced by companies, innovators, and providers. We concentrate on the development and protection of patent rights, equipping clients with the necessary opinion letters on matters such as patent validity, infringement, and freedom to operate. Additionally, we represent hospitals and healthcare providers in various areas, from technology transfer to the protection of trade secrets, and from branding to the rebranding of properties and businesses.
Labor and Employment
Clients from the healthcare industry seek our guidance on a comprehensive scope of labor and employment challenges, including matters such as employee discipline and discharge, privacy rights, wage-hour concerns, medical accommodations, and hiring protocols. Our efforts extend beyond consultation—we are actively involved in representing clients in litigation and administrative proceedings. This includes defending against discrimination litigation and charges before the EEOC and state antidiscrimination agencies, as well as disputes involving noncompetition agreements.
Licensing and Technology
At our firm, we aid clients in navigating intricate software systems and service agreements—be it for electronic medical record (EMR) systems, accounting systems, or billing systems. Our expertise extends to complex procurement and distribution arrangements, which we've approached from both vendor and customer standpoints, group purchasing organizations included. We're adept at engineering sophisticated data sharing agreements and have a wealth of experience in negotiating equipment purchase agreements with leading providers of medical equipment.
Real Estate and Land Use
Our expertise extends to real estate and development permitting for healthcare industry clients, encompassing projects such as facility development, acquisition and disposition transactions, as well as land use and environmental permitting. We provide extensive counsel to a range of facilities, from hospitals to medical campuses and research centers, to assisted living facilities, on various land use and governmental entitlements.
Restructuring and Bankruptcy
Within the realm of secured creditors and bondholders, we are recognized for our role in enforcing rights and remedies related to defaults in financing instruments. We are adept at navigating the acquisition of healthcare assets through forced sales, foreclosures, and bankruptcy proceedings, and are experienced in dealing with governmental entities to set up receiverships for facilities that are either in default or operating below standard. Our adeptness extends to engaging with regulatory authorities and governmental healthcare finance agencies.
Insights
News
Professional Experience
Reimbursement Litigation and Public Contracting
- Successfully defended academic medical center in putative class action involving hospital charges to uninsured patients.
- Represented managed care organization in Medicaid reimbursement litigation regarding allocation of Affordable Care Act expansion population among contracted Medicaid plans. After winning summary judgment, recovered $10.35 million for CHPW. Also successfully defended CHPW against a $20 million contract claim asserted by HCA in related administrative adjudication proceeding.
- Represented skilled nursing facility in judicial review of Medicaid cost report appeal. Washington Supreme Court upheld award to the facility and invalidated as unconstitutional statutes and regulations that purported to retroactively clarify payment scheme.
- Represented academic medical center in Medicaid reimbursement contract litigation against Oregon managed Medicaid plan for wrongful underpayment. During trial, obtained seven-figure settlement for the medical center that exceeded the damages alleged in its complaint.
- Represented taxpayer in a successful challenge to the application of city business and occupation tax to revenues that were preempted by state and federal law.
- Represented large Seattle, Washington based nonprofit healthcare organization for refund of B&O tax paid on Medicare-Advantage premium receipts under state and federal preemption law.
- Represented pharmacy associations and individual pharmacies in action against state Medicaid agency; obtained temporary restraining order enjoining reduction in Medicaid pharmacy reimbursement.
- Represented association health plans in successful challenge of state insurance commissioner’s denial of rate filings.
- Represented healthcare contractor in successful bid protest challenging its exclusion from the competitive range under a large Medicare services acquisition.
- Obtained permanent injunction shutting down CMS Medicare demonstration project as unlawful.
False Claims and White Collar Defense
- Represented health system in False Claims Act litigation related to provision of radiology services. Obtained dismissal of case with prejudice.
- Defended health maintenance organization and associated providers in False Claims Act litigation and obtained government declination of intervention, early dismissal of False Claims Act and other allegations and summary judgment relative to whistleblower retaliation allegations.
- Represented four hospital defendants in False Claims Act litigation related to investigational cardiac procedures billed to Medicare. Defendants obtained a dismissal of the U.S.’s complaint due to statute of limitations issues.
- Represented University faculty practice plan in False Claims Act litigation related to teaching physician billing to Medicare and Medicaid. Matter settled before trial.
- Represented defendant physician group in False Claims Act litigation alleging pathology service fraud. District court dismissal of complaint on jurisdictional ground initially reversed by appellate court. Defendants later won summary judgment dismissal of the case, which was affirmed by Ninth Circuit.
- Represented hospitals and health systems in connection with Department of Justice’s national investigations related to site of service for performance of kyphoplasty procedures and Medicare coverage of implantable cardioverter defibrillators (ICDs).
- Defended research institution and Nobel laureate in defending scientific fraud allegations, resulting in government declination and dismissal of case.
- Represented teaching hospitals accused of defrauding Medicare by billing for procedures allegedly involving non-FDA approved cardiac devices.
- Represented provider of geriatric psychiatric services in qui tam action. Obtained government declination of intervention and dismissal of case.
- Represented defendant health care system and hospital in dismissal of False Claims Act litigation alleging medically unnecessary services and falsification of documentation.
- Represented California subacute care facility in obtaining state declination of intervention and dismissal of action in an action brought under California False Claims Act.
- Defended Medicare Advantage health plans in Department of Justice investigation of alleged false claims submissions relating to risk adjustment submissions.
- Represented nationwide pharmacy provider in obtaining dismissal of False Claims Act litigation relating to, among other things, alleged routine waiver of copayments.
- Represented clinical laboratory in Department of Justice investigation of alleged kickbacks, Stark law violations, and false claim submissions.
- Represented diagnostic imaging center in connection with False Claims Act settlement and compliance with corporate integrity agreement.
- Obtained a dismissal of qui tam action filed against 40 pharmaceutical companies alleging False Claims Act violations based on alleged FDA regulatory violations.
- Defended clients in False Claims Act litigation alleging Medicare hospital cost report fraud related to air ambulance service. Court dismissed complaint under public disclosure bar.
- Represented defendants in a False Claims Act lawsuit alleging fraud in university foreign translation services. Summary judgment dismissal of case affirmed.
- Represented the defendant hospital system in False Claims Act litigation arising from alleged home health care fraud. Obtained a dismissal of False Claims Act allegations before trial.
- Represented the Defendants in False Claims Act lawsuit alleging fraud in partial hospitalization psychiatric service. Initial complaint dismissed by District Court, and case subsequently dismissed on jurisdictional grounds.
- Lead counsel in a multihospital internal investigation of clinical research misconduct and improper research billing, resulting in no sanctions from the FDA, OHRP, ORI or CMS.
- Defended academic medical center in federal DEA and DOJ action related to controlled substance diversion.
- Defended compounding pharmacy in federal fraud investigation related to marketing.
- Represented pharmacy in a disciplinary proceeding by state Board of Pharmacy, resulting in no charges or penalties.
Off-Label Promotion Litigation
- Represented pharmaceutical and device manufacturer in False Claims Act litigation for alleged off-label promotion and quality issues.
- Represented health system and pediatric psychiatrist in obtaining early dismissal with prejudice in False Claims Act litigation related to Medicaid payment for psychiatric medications prescribed off-label to minors.
Regulatory Compliance
- Lead strategic and regulatory counsel in the application to the FDA for 510(k) approval of an in vitro diagnostic medical device.
- Lead regulatory counsel in the development of a nation-wide biospecimen and clinical data collection and material transfer program for one of the largest for-profit health care systems in the country.
- Counsel in the formation, development and growth of a multistate-physician medical clinic focused on infectious disease diagnosis and treatment.
- Represented numerous medical providers in connection with Department of Health and state medical board licensing investigations and complaints.
- Represented various healthcare facilities in connection with Department of Health licensing investigations and complaints.
- Represented academic medical center and personnel in pharmacy board investigations related to drug compounding standards and USP 797.
Corporate Structuring and Transactions
- Represented numerous healthcare joint ventures for a range of services, including diagnostic services, cancer treatment services and for ambulatory surgery centers. Ventures have included physician and other professional owners, hospital venture partners and business partner participants. Representation has also included “provider based” joint ventures as permitted by Medicare rules.
- Represented both buyer and seller parties in transactions involving long-term leases of public hospital district facilities by hospital systems.
- Advised private equity firm in acquisition of home health equipment leasing company operating in multiple states.
- Represented private equity owned urgent care provider in complex reorganization for long-term management and sale-leaseback of facilities.
- Counsel to community hospital regarding structuring joint service arrangement with cardiology practice to retain cardiology services in Eastern Washington community.
- Counsel to multispecialty clinic of over 200 providers in connection with an affiliation transaction with a national hospital company.
- Counsel to reorganization of community primary care clinic and family practice residency program as a federally qualified health center.
- Counsel to faculty practice plan for school of dentistry in connection with reorganization of governance of plan.
- Lead strategic counsel for the development of a multihospital, nationwide clinical research network conducting industry-sponsored and NIH-funded clinical studies.
- Lead regulatory and corporate counsel in the formation of a private equity funded joint venture to acquire an existing life insurance company and to repurpose the company into a new Medicare Part D insurance provider serving over 100,000 people.
- Lead counsel in the sale of a 70-physician anesthesia group to a practice management company funded by private equity.
- Represented largest provider of rehabilitation health care in numerous private security syndications.
- Represented numerous clients in tracking and identifying bond project expenditures in connection with mergers, spin-offs and tax compliance.
Privacy and Data Security
- Represented a healthcare vendor in securing protected health information and non-public personal financial information which was seized by a subcontractor’s creditors.
- Represented a consortium of 50 hospitals in drafting all security policies required to comply with HIPAA.
- Represented covered entities (healthcare providers and health plans) and business associates with respect to compliance with HIPAA, as amended by the HITECH Act, and related regulations.
- Represented a national healthcare system in the creation of registration authorities, certificate practice statements, certificate policies and relying party agreements.
- Advised a multi-billion dollar retail entity in compliance with HIPAA and Gramm Leach Bliley privacy requirements by helping it establish a compliance office to oversee the retailer’s procedures.
Finance
- Represented healthcare administration company in connection with growth-stage financing while simultaneously considering two separate potential acquisitions of the company by large strategic acquirers.
- Represented national ambulatory surgery management company in its private equity backed financings, numerous acquisitions and joint ventures, public offerings and sale for $600 million.
- Represented leading company in image-guided laser tumor therapy in its venture capital and debt financing transactions.
- Represented major national health system in its bond offerings throughout the country.
- Represented health system in California in working capital tax-exempt borrowings and successfully transferred control to preserve existing bonds and avoid default.
General Counsel Services
- Counsel to medical practices in transaction merging different specialty practices to share common infusion and pharmacy services while maintaining division autonomy within specialties.
- Represented high risk pool in connection with organization and contract with Department of Health and Human Services for operation of the transitional federal high risk pool.
- Lead health law counsel in the structuring and implementation of a multi-state franchise operation of a medical practice management company.
- Special counsel to the office of general counsel to co-architect the formation, development, and implementation of an office of sponsored research in one of the largest public health systems in the country.
- Represented large Seattle-based nonprofit health provider in connection with long-term lease and operating agreement of public hospital facility.
Healthcare Antitrust and Unfair Competition
- Trial counsel for large medication monitoring services company in obtaining a $14.8 million trial court verdict against rival laboratory for alleged false advertising and unfair competition in the drug-testing market case. (The verdict was later vacated on jurisdictional grounds.) The trial found that provision of physicians drug-test cups violated the anti-kickback and other laws, and rejected all counterclaims by defendant in the suit.
- Represented hospital and physician defendants in hospital peer review antitrust action by obstetrician. Obtained dismissal of the federal Complaint and obtained defense summary judgment and award of substantial attorney fees.
- Represented health system in defense of antitrust claim in radiology and diagnostic imaging markets. Obtained dismissal of case.
- Represented a defendant hospital in antitrust litigation relating to alleged conspiracy to monopolize general surgery market. Matter settled with nominal contribution by hospital.
- Represented medical center in action by physician asserting antitrust claims and claims related to the federal Stark Law's recruitment exception; obtained dismissal with prejudice of all claims.
Labor, Employee Benefits and Medical Staff Credentialing
- Represented multinational aerospace manufacturer in connection with the creation of Accountable Care Organization/preferred provider programs offered in Washington, Missouri, South Carolina and Southern California.
- Represented regional medical center in physician challenge of hospital’s adoption of medical staff credentialing criteria for interventional cardiology. Obtained dismissal of related claims and award of attorney fees for hospital under Washington Peer Review Act.
- Represented oncology practice in successful action to enforce covenants not to compete against departing shareholder and employed physicians.
Licensing and Technology
- Represented a large hospital system in an HR sourcing for administration of medical and dental plans, disability, long term care, AD&D, employee assistance, and other benefit plans.
- Represented multiple entities in data licensing arrangements in retail, healthcare, and energy industries.
- Represented multiple hospital systems in negotiations with EMR providers for EMR acquisition and implementation. Most recently represented a healthcare system in the acquisition of a replacement EMR solution involving a total cost of $150 million.
- Represented healthcare revenue cycle vendors in negotiations with hospital systems to provide end to end or a la carte revenue cycle services.
- Represented healthcare data analytics non-profit that leverages data in a hospital’s EMR to provide real time patient risk analytics in negotiating services arrangements with multiple hospital systems.
- Represented healthcare system in negotiating arrangement to develop a custom patient accounting system.
- Venture counsel for joint hospital-physician organization to enhance pediatric medical care and provide electronic medical records and related information technology services to community pediatric providers.
- Counsel to statutorily-constituted nonprofit organization funding universal pediatric vaccine program providing start-up and ongoing representation.
Real Estate and Land Use
- Counsel to urban hospital in connection with development of off-campus medical office complex including ambulatory surgery and other out-patient services. Engagement included real estate development, certificate of need, and counsel to negotiations with physician groups.
- Represented large integrated health systems in the development of medical office buildings and hospitals.