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Healthcare

Healthcare

Healthcare spending in the US accounts for over 17 percent of gross domestic product and is expected to be a $4 trillion dollar industry by 2021. Bracewell’s team of healthcare lawyers advises major research institutions, academic medical centers, hospitals, health systems, surgery centers, physicians, physician practices, healthcare clinics, life science companies, non-profit corporations, charitable trusts and all other healthcare-related enterprises, on a wide variety of matters relating to corporate governance, strategic relationships and partnerships, finance, employee relations, data security, medical records maintenance, regulatory compliance, tax, antitrust, intellectual property matters, and litigation.  We work with our clients to secure financing for new and expanded operations, monetize intellectual property assets, develop and execute electronic record management, mergers and acquisitions, and ensure effective corporate governance.

Our integrated team counsels our clients on operational and transactional healthcare compliance, including matters arising under the Affordable Care Act (ACA), the Health Insurance Portability and Accountability Act (HIPAA), the Stark Law, the federal “Anti-Kickback” Statute, the Civil Monetary Penalties Law, the False Claims Act, and laws governing the corporate practice of medicine. We also regularly advise clients in the healthcare industry with respect to managed care contracts, affiliation agreements, clinic coverage agreements, data collaboration agreements, contracts between physicians, hospitals, and other health-care enterprises, and the formation of joint ventures. We also possess significant experience in defending clients in civil, criminal and/or regulatory investigations and prosecutions from both state and federal healthcare regulators, including investigations and prosecutions involving the Department of Justice, the Office of Inspector General of the Department of Health & Human Services (HHS), the Internal Revenue Service (IRS), and various states’ Attorneys General. Our attention is on our clients’ business so that they can focus on what they do best—treating patients and curing disease.

Experience

Recent Notable Matters

Dental Support Organization — successfully represented an executive in parallel criminal and False Claims Act civil proceedings resulting in federal and state non-prosecution and civil settlement with no finding of liability

Health care organization — guidance relating to the rules and regulations enacted as part of the Affordable Care Act, including Internal Revenue Code Section 501(r)

Health service organization — drafting terms and conditions, privacy policy, security policy, and software license agreement for client providing services to college and university campuses

Healthcare organization — structured joint ventures and partnerships with for-profit entities to protect continued tax-exempt status of exempt participants

Hermann Hospital — negotiations with the IRS involving the hospital’s participation in certain physician recruitment activities, resulting in a closing agreement with the IRS that contained detailed physician recruitment guidelines, serving as the forerunner to Revenue Ruling 97-21 dealing with physician recruitment

Independent, non-profit biomedical research institution — draft and negotiate a variety of research and data sharing agreements and develop patent portfolio to facilitate institutional interests regarding the effects of human genetics on health outcomes and development of diagnostics and therapeutics for combating infectious diseases

Large Dental Provider — corporate and compliance matter representation for dental provider with over 170 locations in the United States

Lingualcare — Dallas-based orthodontic technology and services company offering the iBraces system, a customized, lingual orthodontic solution, in connection with its sale to 3M, and related corporate matters

Major hospital systems — creation of whole hospital joint ventures combining health care activities of the nonprofit systems with the operations of investor-owned hospital systems, structured to address control requirements necessary to preserve the nonprofit hospital systems' continuing tax-exempt status

Medical research and development institutions — prepare and prosecute patent and trademark applications relating to biological compositions and  processes involving nucleic acids, antibodies, cell lines, and pharmaceutical formulations

Multi-hospital health care system — IRS examination of client’s partnerships with proprietary health care providers

Multiple Healthcare Providers, DME/Pharmaceutical Interests, Compounding Pharmacies, Wholesalers and Genetic Labs — defense of companies and principals in regards to allegations of healthcare fraud/anti-kickback violations

Numerous companies and individuals — defending in connection with federal and state whistleblower lawsuits and resulting civil and criminal investigations conducted by HHS-OIG, the FBI, U.S. Attorney’s Offices, and state Medicaid officials

Numerous non-profit hospitals, long-term care facilities, and other healthcare facilities — borrowings and restructurings, including synthetic fixed-rate refundings, direct placement financings, new money financings, and post-issuance remedial action

Parkland Center for Clinical Innovation (PCCI) — sophisticated and complex spin-off transaction involving the licensing of software to Pieces Technologies, Inc. (Pieces Tech), an innovative healthcare analytics entity that deploys cutting-edge technology to improve clinical and community health outcomes; Pieces Tech officially launched with a $21.6 million Series A funding round led by Pacific Advantage Capital (PAC Partners) and Jump Capital, with participation from various healthcare systems and select Dallas family offices, among others

Predictive health intelligence company — a variety of intellectual property matters, including patent applications, licensing transactions with universities and corporations, and due diligence for strategic alliances with other genomic diagnostic companies

Privately Held Remote Pharmacy Company — recapitalization by private equity firms led by DFW Capital Partners, a New Jersey-based venture capital fund, and in prior private equity investment by NeighborCare, Inc. (now known as Omnicare, Inc.), as well as compliance matters governing remote pharmacies

Texas Hospital Network — designed FCPA policy and procedures for organization and its doctors to participate in joint ventures with various ministries of health in developing countries

Texas Medical Center — development of a 28-acre biomedical innovation and commercialization campus known as TMC3 which will be a cooperative development between the medical center and four public or non-profit medical institutions, including a world-renowned cancer center and a major public university’s health center

The Menninger Clinic — advise on all aspects of corporate governance, employee relations, HIPAA, data protection, intellectual-property management and monetization, and litigation defense

The University of Texas MD Anderson Cancer Center — broad exclusive licensing agreements and equity documents with respect to, among others, the following issuers: (a) Intrexon Corporation and ZIOPHARM Oncology; (b) Immatics US, Inc., with respect to structuring the initial round of a $60 million Series A financing round; and (c) OncoResponse, an immuno-oncology antibody discovery company that was launched jointly by MD Anderson and Theraclone Sciences, which led the Series A Preferred Stock round, and which included ARCH Venture Partners, Canaan Partners, William Marsh Rice University and Alexandria Real Estate Equities

Two major health care systems — IRS examinations of "acquisition financings" undertaken to facilitate the combination of previously unrelated health care systems to create the two systems, resolving both examinations in a manner that preserved the acquisition financing treatment and continued tax-exempt status of the bonds

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