Industries

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Academic Medical Centers

Sonnenschein represented a large health system client in the class action antitrust lawsuit filed by several medical residents against various hospitals and medical schools that sponsor residency programs, as well as several medical organizations, such as the American Association of Medical Colleges, the American Hospital Association, the American Medical Association, and the National Resident Matching Program.  The lawsuit alleges that the match of medical students to residency programs, the accreditation rules for residency programs, and several surveys of resident stipends/benefits were part of a conspiracy to reduce the stipends and other benefits provided to medical residents in violation of antitrust laws. On behalf of an institutional provider (and triggered by a whistleblower complaint), Sonnenschein attorneys coordinated an extensive internal investigation of time and effort reporting and federal grant cost allocation issues.  Despite involvement by the FBI and the U.S. Attorney's Office, the matter was resolved without the imposition of fines or penalties. Sonnenschein attorneys assisted a large university in developing strategies to unify dozens of their faculty practice plans into one multi-specialty faculty practice plan while complying with the federal and state anti-kickback, physician self-referral, and related laws and regulations. Firm attorneys conducted a HIPAA training seminar for more than 40 AMCs nationwide. Sonnenschein prepared HIPAA-compliant authorization forms and IRB/Privacy Board policies and procedures, and trained IRB members and hospital staff regarding HIPAA's impact on clinical research. Sonnenschein attorneys developed an agreement among five AMCs for cooperative multi-center clinical trial research designed to facilitate the ability of all five institutions to attract clinical research as a group. Firm attorneys conducted an internal audit of the research-related billing practices of a health system and prepared policies and procedures to ensure ongoing compliance with federal and private payor requirements. The firm has represented a variety of institutions and investigators in connection with allegations of research misconduct. On behalf of both sponsors and institutions, Sonnenschein attorneys have negotiated clinical research, confidentiality, non-disclosure and indemnification agreements. Sonnenschein attorneys represented an AMC in connection with the development of a research park and a proposed asset sale of a university hospital and clinical facilities to a large, for-profit hospital chain. In connection with an IRS Coordinated Examination Program audit, Sonnenschein attorneys successfully argued that a university's revenues received from clinical trial research were substantially related to its tax-exempt purposes and, as such, not subject to unrelated business income tax. In a first-of-its-kind transaction, a multidisciplinary team of Sonnenschein attorneys represented a university and a not-for-profit consortium of universities in connection with the construction of a 1,750-bed student dormitory and multiuse facility in Chicago.  This representation included:  (1) structuring and forming the consortium; (2) negotiating a redevelopment agreement with the City of Chicago; (3) obtaining the necessary public approvals and required tax exemption; and (4) handling related federal income tax matters and the issuance of $150 million in tax-exempt bonds. On behalf of an AMC, Sonnenschein attorneys provided legal services in connection with the sale to a national health plan of an HMO jointly owned by a hospital and a medical school. Sonnenschein attorneys represented a teaching hospital in a joint venture with oncologists to (1) purchase PET/CT scanners, linear accelerators and other equipment used in the diagnosis and treatment of cancer and (2) lease that equipment to the hospital for use in its cancer center. Firm attorneys counseled a prominent teaching hospital on how to structure its multimillion-dollar personal services and clinical research support arrangements with the hospital's affiliated university and faculty plan to comply with federal anti-kickback and physician self-referral laws. Firm attorneys successfully represented two AMCs under investigation as part of the federal government's Physicians At Teaching Hospitals (PATH) initiative. Firm attorneys represented a university health system with appropriations counsel, Congressional outreach and agency partnership development.  Sonnenschein provided assistance and counsel to the health system's venture capital arm in the development of new technologies through research and development, and with agency and Congressional relationship-building initiatives.

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Clinical Laboratories

On behalf of a company considering the establishment of a clinical laboratory, firm attorneys summarized the principal registration and documentation requirements for clinical laboratory services furnished by an independent diagnostic testing facility (IDTF) on behalf of Medicare patients. On behalf of a clinical laboratory, firm attorneys analyzed the impact of new CMS regulations and national coverage decisions on Medicare documentation requirements and the claims review process. Sonnenschein attorneys advised a clinical laboratory regarding federal law, regulations and other guidance to determine if Medicare Part B would reimburse a Medicare beneficiary for testing services furnished by a clinical laboratory that did not have a Medicare billing number. Sonnenschein attorneys provided advice to a clinical laboratory concerning the appropriate design of a physician requisition form to support Medicare reimbursement for glycated hemoglobin testing. Firm attorneys analyzed whether Medicare Part B would cover clinical diagnostic laboratory tests ordered by a supervising physician in an IDTF, and whether the physician would be engaging in the unauthorized practice of medicine if the specimen at issue was received from an out-of-state Medicare beneficiary. Sonnenschein was counsel to a private equity firm in its purchase of a series of clinical laboratories, and continues to provide regulatory and fraud and abuse counsel to that laboratory chain.  Before joining Sonnenschein, a Health Care Group attorney spearheaded a national clinical laboratory False Claims Act project for the federal government and was involved in major "Operation Labscam" settlements and corporate integrity agreements.

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DME & Other Suppliers

Following over 30 depositions, extensive discovery and briefing, Sonnenschein attorneys successfully defended a DME supplier of specialty pressure relief mattresses in False Claims Act qui tam litigation against whistleblowers and the Department of Justice, securing summary judgment on a $180,000,000 claim.  In addition to obtaining an across-the-board victory on the merits, Sonnenschein also obtained a court order for DOJ's payment of the client's attorney’s fees in connection with the litigation. Sonnenschein attorneys advise a publicly-traded, national oxygen and inhalation therapy company regarding CMS regulatory developments and DMERC/DME-MAC local coverage determinations. On behalf of a medical products manufacturer, Sonnenschein attorneys provided counseling regarding pricing issues.  On behalf of a national association of home medical equipment suppliers and home health agencies, Sonnenschein attorneys and public policy professionals devised and executed a comprehensive strategy to minimize Medicare reimbursement cuts on a variety of DME items. On behalf of a medical device manufacturer, firm attorneys analyzed the fraud and abuse implications of an arrangement pursuant to which the manufacturer would offer one item at no separate charge provided the customer purchased another item at designated volumes and prices.  On behalf of a DME manufacturer, Sonnenschein attorneys developed a comprehensive reimbursement primer explaining Medicare coverage, coding and reimbursement issues for the manufacturer's customers (including nursing homes, home health agencies and hospitals). On behalf of a medical device company, firm attorneys analyzed and advised on FDA reporting obligations and potential False Claims Act liability. Sonnenschein attorneys developed comprehensive compliance policies and procedures for a DME manufacturer, addressing areas such as the provision of gifts and gratuities, charitable giving, sponsorship of events and educational grants. Sonnenschein attorneys advised a DME supplier on OIG advisory opinion issues and provided counsel on sales and marketing activities.

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Group Purchasing Organizations

Practice Group attorneys represented three national hospital alliances and group purchasing organizations in connection with proceedings initiated by the HHS-OIG as well as multiple State Attorney General Offices and State Medicaid Fraud Control Units.  Sonnenschein attorneys assisted one of the largest national group purchasing organizations (GPOs) in preparing to testify before the United States Senate on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights concerning its business operations and advised the GPO in ensuing negotiations related to the GPO’s business model.  Thereafter, we advised the GPO on the development and implementation of policies and procedures designed to allay the Senate’s concerns.  One-year later, Sonnenschein again assisted the GPO to prepare and present a “progress report” to the Senate Subcommitee.   Health care attorneys assisted a national group purchasing organization in connection with an investigatory audit initiated by the HHS-OIG Office of Audit Services. On behalf of multiple national group purchasing organizations (GPOs), our health care attorneys analyzed vendor and provider contracts and each GPO’s vendor selection process under Federal and State anti-kickback, physician self-referral, antitrust and gainsharing laws. Sonnenschein attorneys advised a national group purchasing organization (GPO) in connection with a joint venture arrangement between the GPO and a national insurance company. On behalf of several national group purchasing organizations (GPOs), practice group attorneys have developed corporate compliance plans specifically designed to meet the unique needs of the GPOs and provided guidance on the application and implementation of such plans.  Practice Group attorneys have assisted several national group purchasing organizations (GPOs) in exploring and developing alternative purchasing programs to better meet the needs of GPO members.

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Health Information Technology Companies

Sonnenschein attorneys have advised an Internet disease management company regarding State practice of medicine laws, drafted agreements (e.g., Web Site Terms and Conditions, Privacy Policy, Membership/User Agreements, etc.), and provided guidance regarding the HIPAA privacy and security regulations.  For a physician-owned Internet start-up company, Firm attorneys completed a Federal and comprehensive multi-state survey of anti-kickback, self-referral and fee-splitting laws and regulations and provided advice on an organizational structure designed to comply with such laws.  In addition to providing general advice on corporate/transactional matters, firm attorneys drafted the company’s Internet agreements as well as its membership/user agreements and physician participation agreements.  Sonnenschein attorneys provided privacy, security and regulatory counseling to a publicly traded application service provider and software vendor servicing health plans and insurance companies. Sonnenschein provides a large health information technology vendor with the full array of compliance counsel including reviewing contract agreements with providers to assure compliance with State and Federal fraud and abuse laws as well as compliance with the HIPAA Private Rule and its State counterparts. Firm attorneys provided advice to a large health care data clearinghouse on structuring its operations in compliance with State and Federal privacy obligations, including the HIPAA Privacy Rule and State law restrictions on the use and disclosure of social security numbers.  Sonnenschein represented a top 10 financial institution in the Federal marketing and deployment of electronic claims and payments processing technologies with the Department of Veterans Affairs and Centers for Medicare & Medicaid Services.

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Hospitals & Health Systems

Sonnenschein attorneys defended a teaching hospital in an antitrust class action by hospital residents relating to the hospital’s residency programs.   On behalf of a major health system, Sonnenschein obtained FTC business review regarding the Non-Profit Institutions Act.  The Firm represented a hospital in a government investigation of contracting practices with employed physicians.  We represented a hospital system in connection with a proceeding concerning the sale of an HMO to a competing HMO.  Firm attorneys advised a hospital system regarding issues concerning affiliation with a major multi-specialty physician group and an HMO owned by the group.   The Firm advised a group of specialists in connection with the development of a specialty hospital.  Sonnenschein attorneys advised a hospital system regarding joint ventures with physicians The Firm has represented several providers in connection with FDA bioresearch monitoring investigations of IRBs.  On behalf of an institutional provider (and triggered by a whistleblower complaint), Sonnenschein attorneys coordinated an extensive internal investigation of time and effort reporting and Federal grant cost allocation issues.  Despite involvement by the FBI and the U.S. Attorney’s Office, the matter was resolved without the imposition of fines or penalties.  Sonnenschein prepared HIPAA-compliant authorization forms and IRB/Privacy Board policies and procedures, and trained IRB members and hospital staff regarding HIPAA’s impact on clinical research.  Sonnenschein attorneys developed an agreement among five academic medical centers for cooperative multi-center clinical trial research designed to facilitate the ability of all five institutions to attract clinical research as a group.  Sonnenschein conducted an internal audit of the research-related billing practices of a health system and prepared policies and procedures to ensure ongoing compliance with Federal and private payor requirements.  On behalf of several teaching hospitals, the Firm has created (and regularly updates) IRB standard operating policies and procedures.  On behalf of a medical school, Sonnenschein attorneys conducted an internal audit of selected clinical study and IRB files in an effort to determine compliance with FDA medical device and FDA and HHS human subject regulations.  In connection with an IRS Coordinated Examination Program audit, a Sonnenschein attorney successfully formulated and briefed the position of a university that all revenues received from clinical trial research were substantially related to the university’s tax-exempt purposes and, as such, not subject to unrelated business income tax.  The Firm has represented a variety of institutions and investigators in connection with allegations of scientific misconduct.  On behalf of both sponsors and institutions, Sonnenschein attorneys have negotiated clinical research, confidentiality, non-disclosure, and indemnification agreements.  Sonnenschein attorneys represented an academic medical center in connection with the development of a research park and a proposed asset sale of a university hospital and clinical facilities to a large, for-profit hospital chain.  On behalf of a not-for-profit health system, Sonnenschein attorneys structured the affiliation between one of the system’s hospitals and a large multi-specialty medical group.  This matter involved the extension of a subordinated loan facility to the medical group to satisfy the solvency requirements of its provider-sponsored health maintenance organization, and the negotiation of equity participation by the hospital in the medical group.  Through the Illinois Health Facilities Authority, Sonnenschein attorneys have served as counsel to a hospital, medical center and health plan in connection with a series of publicly and privately issued bonds, totaling approximately $100 million, for improvements to existing structures and the development of new facilities. On behalf of a large community hospital, Sonnenschein attorneys developed and implemented an affiliation with another community hospital in the State, designing a unique structure that balanced the need for continued local hospital influence with the benefits of regional system integration. Sonnenschein attorneys represented a not-for-profit hospital in the development of a joint venture heart hospital with approximately 75 local cardiologists and cardiovascular surgeons.  This representation involved the preparation of a comprehensive offering memorandum (identifying investment, business, governmental, and tax risk factors) for distribution to potential investors. On behalf of an academic medical center, Sonnenschein attorneys provided legal services in connection with the sale of a health maintenance organization jointly owned by the hospital and a medical school to a national health plan. The Firm advised a hospital on setting up a governing board process for the review and approval of compensation for individuals likely to fall within the category of “disqualified persons” under intermediate sanction regulations. Sonnenschein assisted a teaching hospital in restructuring its cardiovascular surgery program, which involved recruiting a nationally recognized cardiovascular surgeon to assume the role of chair of the newly created cardiovascular services department and negotiating and drafting the medical director agreement, professional services agreement, and other ancillary agreements between the surgeon, his professional corporation, and the hospital. Sonnenschein attorneys represented a teaching hospital in a joint venture with oncologists to form a limited liability company (1) to purchase state-of-the-art equipment, including PET/CT scanners, linear accelerators and other equipment used in the diagnosis and treatment of cancer and (2) to lease that equipment to the hospital for use in its cancer center. The Firm represented a group of hospitals in connection with the restructuring of their existing senior and subordinated debt agreements and negotiation of a new health care receivables purchase facility. Sonnenschein has served as primary intellectual property counsel for a large teaching hospital and its foundation, providing patent preparation and prosecution, litigation, and licensing services. On behalf of one of the nation’s most prestigious health systems and three of its hospitals (one of which is a prominent teaching hospital), Sonnenschein attorneys reviewed and analyzed dozens of arrangements between and among the health system, hospitals, medical groups under contract with the hospitals, and scores of physicians affiliated with these medical groups under Federal and State anti-kickback, physician self-referral, and reassignment laws.  Sonnenschein represented an academic medical center operating under State authority in connection with a multi-million dollar civil False Claims Act (qui tam) action alleging that the center and numerous faculty departments had engaged in various fraudulent billing and coding schemes.  The case ultimately was dismissed without the imposition of damages, fines, or a corporate integrity agreement. On behalf of a hospital, Firm attorneys reviewed and analyzed a proposed joint venture between the hospital and various physicians to develop and operate an ASC under Federal and State anti-kickback and physician self-referral laws.  Sonnenschein has represented numerous hospitals (as well as other providers and suppliers) in Medicare overpayment disputes and audits involving fiscal intermediaries and carriers.  For example, Sonnenschein attorneys worked with a large community mental health provider to reduce a $1 million overpayment demand to less than $40,000.  Firm attorneys recently counseled a prominent teaching hospital on how to structure its multi-million dollar personal services and clinical research support arrangements with the hospital’s affiliated university and faculty plan to comply with Federal anti-kickback and physician self-referral laws.  The Firm furnished advice to a medical school on structuring faculty incentive compensation in accordance with Federal anti-kickback, physician self-referral, and gainsharing laws.  Firm attorneys successfully represented two academic medical centers under investigation as part of the Federal government’s Physicians At Teaching Hospitals (PATH) initiative.  On behalf of a large health system client, Sonnenschein is involved in the class action antitrust lawsuit filed by several medical residents against various hospitals and medical schools that sponsor residency programs, as well as several medical organizations, such as the American Association of Medical Colleges, the American Hospital Association, the American Medical Association, and the National Resident Matching Program.  The lawsuit alleges that the match of medical students to residency programs, the accreditation rules for residency programs, and several surveys of resident stipends/benefits were part of a conspiracy to reduce the stipends and other benefits provided to medical residents in violation of antitrust laws.  Practice Group attorneys have represented three national hospital alliances and group purchasing organizations in connection with proceedings initiated by the U.S. Senate, the HHS OIG, and various State Medicaid Fraud Control Units.  Firm attorneys helped various hospital systems design and implement corporate compliance programs and detailed, written policies and procedures relating to Medicare and Medicaid coverage, billing, and reimbursement practices.  Sonnenschein attorneys have provided guidance to a health system in connection with both HIPAA privacy and security issues and fraud and abuse/self-referral issues raised in connection with its conversion to an electronic medical records system and the provision of computer access/equipment to medical staff physicians.  Firm attorneys have developed policies and procedures for various health care providers in preparation for JCAHO, NCQA, and contracted health plan surveys.  On behalf of hospitals and other providers, Sonnenschein attorneys have performed legal assessments of disciplinary and deficiency allegations, responded to inspection and survey reports, and challenged inspection and survey findings.  Sonnenschein attorneys have counseled clients and obtained advisory opinions regarding the CON implications of a variety of projects, including the creation and/or discontinuation of categories of service and substantial renovation and construction projects.  The Firm also advises clients regarding threshold issues such as expenditure minimums and covered health services definitions.  The Firm represented a California hospital in the reinstatement of its Medicare certification after it was decertified for EMTALA “patient dumping” violations.  Sonnenschein attorneys have conducted comprehensive facility-wide surveys and recommended courses of action to resolve identified deficiencies in Medicare Conditions of Participation, State licensing regulations, JCAHO, NCQA and other applicable standards.  On behalf of numerous hospitals, Firm attorneys have prepared, reviewed and revised medical staff bylaws, ensuring compliance with JCAHO accreditation medical staff standards.  Sonnenschein attorneys have designed institutional policies and procedures to comply with Medicare Conditions of Participation and State licensure requirements for numerous hospitals and other providers.  The Firm negotiated with regulators in connection with placing a client-hospital’s license in suspension during a bankruptcy auction to facilitate the eventual purchase of the facility by another hospital operator.  Sonnenschein attorneys have advised cancer centers, radiation oncology centers and medical office buildings regarding alternative structures for various projects and joint ventures in order to avoid CON requirements (or minimize CON implications).  Sonnenschein health care attorneys represent nonprofit hospitals and their medical staffs in drafting, updating, revising, and interpreting medical staff bylaws. The firm represents nonprofit hospitals and their medical staffs in advising and defending physician peer review and disciplinary matters and investigations. Health care attorneys assist hospitals in drafting conflict of interest policies addressing ownership interests by medical staff members in competing specialty hospitals or ASCs.  Conversely, attorneys advise physicians and physician groups on the reasonableness and appropriateness of such polices as applied to them. Sonnenschein advises hospitals as to the legality, under the Federal anti-kickback and Stark laws, of providing temporary assistance to members of the medical staff in obtaining professional liability insurance in States experiencing severe access or affordability problems.            On behalf of two hospitals preparing for upcoming JCAHO accreditation review, Sonnenschein attorneys updated the medical staff bylaws to incorporate recent accreditation medical staff standards revisions. Firm attorneys provided assistance to a hospital that found it necessary to summarily suspend a medical staff member’s surgical privileges based on imminent danger to patients.  As part of this representation, Sonnenschein assisted the hospital administrators and medical staff officers and committees in meeting the procedural requirements of the bylaws, including providing notice to the physician, conducting the suspension hearing and review process, and reporting the outcome to the National Practitioner Data Bank and State licensing agency.         Sonnenschein attorneys assisted an ambulatory surgical center and its medical staff officers and committees in conducting a peer review investigation into a surgeon’s high complication rate.  Sonnenschein advised nonprofit hospitals and clinics regarding obligations and alternatives for emergency room on-call coverage by their medical staffs and physician contractors. Firm attorneys advise hospitals with regard to closures of hospital services or departments, including notice and comment and related administrative-type hearings, and review of hospitals’ obligations to the members of  medical staff.  Sonnenschein advises hospitals with regard to medical staff organization and structure in connection with hospital mergers and affiliations. Acting as outside general counsel for a hospital system, analyzed the system’s off-campus facilities and operations to ensure compliance with Medicare’s “provider-based” rules.  Firm attorneys represented a community mental health center in a successful effort to significantly reduce an overpayment demand made by the Medicare fiscal intermediary.  Sonnenschein successfully represented an urban hospital in connection with the administrative and judicial appeals process to reverse a Medicare fiscal intermediary’s disallowance of bad debt.  Sonnenschein attorneys have represented various multi-entity tax-exempt health care systems in connection with the formation of joint ventures with for-profit partners, including, advice relating to the organization and operation of the joint venture under the St. David’s and Redlands Surgical cases, Rev. Rul. 98-15, and other standards promulgated by the IRS relating to the participation of a tax-exempt entity in a joint venture.  Sonnenschein attorneys represented various tax-exempt hospitals in connection with the transfer of assets to tax-exempt and for-profit entities, including advice regarding the potential application of inurement, private benefit and intermediate sanctions to the transaction.  The Firm represented tax-exempt hospital with respect to tax-exemption issues arising in connection with the provision of professional courtesy discounts to physicians and other members of hospital.  Sonnenschein attorneys represented a tax-exempt hospital system in connection with the development and implementation of policies and procedures governing compliance with tax-exemption requirements including those relating to (1) physician recruitment and (2) approval of transactions with “insiders.”  On behalf of a health system, which includes a major medical center, HMO, insurance company and various ancillary services, Sonnenschein attorneys provided advice regarding all aspects of HIPAA compliance. On behalf of a Federal contractor/operator of stand-alone primary care clinics for the Department of Veterans affairs, the Firm devised and implemented a comprehensive strategy for engaging individual Members of Congress, relevant Committees of Jurisdiction, and the Department of Veterans Affairs to address issues relating to enrollment, payments, and third-party collections within the VA health care system.  The Firm also provided counsel and assistance with respect to the client’s interest in expansion to the TRICARE market, and the community primary care system of the District of Columbia.  [Hospitals & Health Systems] Firm attorneys represented a university health system with appropriations counsel, Congressional outreach and agency partnership development.  Provided assistance and counsel to the medical center’s venture capital arm in the development of new technologies through research and development, as well as with agency and Congressional relationship building initiatives. Firm attorneys conducted a HIPAA training seminar for more than 40 academic medical centers nationwide. On behalf of a health system, which includes a major medical center, HMO, insurance company and various ancillary services, Sonnenschein attorneys provided advice regarding all aspects of HIPAA compliance.  Sonnenschein attorneys have drafted and negotiated business associate agreements for numerous providers, health care clearinghouses and health plans.

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Insurers & Managed Care Organizations

Through the Illinois Health Facilities Authority, Sonnenschein attorneys have served as counsel to a hospital, medical center and health plan in connection with a series of publicly and privately issued bonds, totaling approximately $100 million, for improvements to existing structures and the development of new facilities. On behalf of an academic medical center, Sonnenschein attorneys provided legal services in connection with the sale of a health maintenance organization jointly owned by the hospital and a medical school to a national health plan. Firm attorneys have provided ERISA-related assistance to a host of entities in the design, implementation, administration, and revision of qualified pension and profit sharing plans, welfare plan arrangements, benefit plans, executive compensation programs, profit-sharing, and stock options, among other benefit offerings.  Health care attorneys advised an insurer concerning its dual role as plan sponsor and provider of insurance coverage to its in-house plans.  Sonnenschein counseled an insurance company concerning prohibited transaction issues in transactions involving insurance company separate accounts with ERISA plan investors and governmental plan investors not subject to ERISA.   Sonnenschein attorneys represented major institutional clients with respect to amendments to post-retirement medical benefit plans in order to reduce or eliminate extremely large potential liabilities.  Sonnenschein defended a major insurer under investigation by the Department of Health and Human Services Office of Inspector General for alleged violations of the Medicare Secondary Payer rules.  The Firm represented the nation’s largest Medicaid managed care plan in litigation and regulatory compliance matters.  Health care attorneys advised a State department of insurance with respect to corporate and regulatory issues involved in the conversion of a not-for-profit health insurer into a for-profit health insurer.  Sonnenschein provided counsel to an insurer regarding the scope of coverage required for post-mastectomy reconstructive surgery under the Women’s Health and Cancer Rights Act.  The Firm advised a large health plan on compliance issues concerning Federal privacy and security rules, as well as health care fraud and abuse laws and regulations.  Sonnenschein attorneys provided privacy, security and regulatory counseling to a publicly traded application service provider and software vendor servicing health plans and insurance companies.  Sonnenschein counseled a national behavioral health plan on privacy and security issues.  The Firm advised an insurer regarding reimbursement issues arising under the Department of Defense Third-Party Payer Program and other coordination of benefit issues.  On behalf of a national insurer, Sonnenschein analyzed Medicare secondary payer issues arising in connection with claims administration and receipt of Medicare demand letters.  On behalf of a large national health plan seeking to expand into consumer financial products as an adjunct to its health plan products, Sonnenschein attorneys provided counsel on the interplay between the HIPAA Privacy Rule and other Federal regulations governing electronic fund transfers.  On behalf of a national insurance association, Sonnenschein attorneys provided regulatory advice on issues of interest to association members and advocated for improvements in enforcement activities undertaken by the Centers for Medicare & Medicaid Services.  Health care attorneys represented a managed care organization with respect to issues arising in connection with a transaction with a tax-exempt entity controlled by a governmental entity.   At the request of three major health insurance associations, Sonnenschein attorneys conducted a nation-wide preemption analysis under the HIPAA and State privacy laws affecting insurers and health care providers.  We also developed a searchable, on-line product to present the analysis.  Sonnenschein attorneys have drafted and negotiated business associate agreements for numerous providers, health care clearinghouses and health plans.  Oh behalf of a number of group health plans, the Firm has amended plan documents in compliance with the HIPAA Privacy Rule.

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Long-Term & Post-Acute Care Facilities

Sonnenschein attorneys represented a national chain of rehabilitation hospitals in connection with alleged billing improprieties concerning the use of ancillary medical supplies.  The Firm conducted an internal investigation, assisted the client in determining the scope of the overpayment at issue, and negotiated a resolution of the matter with the OIG.  The Firm advised physicians and investors on the formation and operation of a new hospice company, advising on corporate structure, regulatory issues and compliance safeguards. Sonnenschein attorneys serve as counsel to a national association of home health agencies and home medical equipment companies, advising on a broad range of regulatory, legislative, and grass-roots initiatives. Sonnenschein is counsel to an investor-owned hospital company with significant number of inpatient rehabilitation units, advising on the development and implementation of new Federal regulations, educating and influencing Congress and CMS on critical issues, and advising extensively on a series of Medicare fiscal intermediary audits of the inpatient rehabilitation facilities.  Firm attorneys represented a long-term acute care hospital on formation, financing, regulatory, IPO, and general corporate issues.  We represent a health care company that owns and operates inpatient rehabilitation facilities in partnership with general acute care hospitals.  Sonnenschein represented the founders of the company on regulatory issues, corporate structuring  and venture financing matters.  We represent the company in its arrangements with the general acute care hospitals and on all other matters. Firm attorneys represented a for-profit hospice company in formation and financing matters.

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Pharmaceutical & Device Manufacturers

The Firm has represented a global pharmaceutical company in federal, state, and county average wholesale price litigation, including consolidated multi-district litigation. Sonnenschein attorneys have advised a major pharmaceutical company on all fraud and abuse aspects of a major new drug launch, including pricing, sales and marketing, reimbursement support, and sales staff training. Sonnenschein attorneys have advised a major pharmaceutical company on all aspects of compliance with its Corporate Integrity Agreement, including the company's independent review obligations. We represented a leading device manufacturer seeking to halt abusive sales practices engaged in by a competitor. The Firm represented a pharmaceutical manufacturer in connection with a nationwide litigation involving claims of equivalence of brand name and generic prescription drugs. Sonnenschein represented a pharmaceutical company in various national price-fixing class actions and related price discrimination litigation.  We represented a pharmaceutical manufacturer in connection with various government investigations of pricing and reimbursement practices.  Sonnenschein has prepared clinical trial research agreements for various pharmaceutical and medical device manufacturers.  On behalf of both sponsors and institutions, Sonnenschein attorneys have negotiated clinical research, confidentiality, non-disclosure, and indemnification agreements.  Firm attorneys analyzed marketing materials developed by a pharmaceutical company demonstrating "spread" between the manufacturer’s products and Medicaid reimbursement, Medicare reimbursement, and private payor reimbursement, under the federal anti-kickback law.    Firm attorneys analyzed the fraud and abuse implications of an arrangement pursuant to which a pharmaceutical manufacturer would provide administrative fees to a PBM as part of an agreement with the PBM covering formulary status of the manufacturer's products.  Health care attorneys represented an industry-leading medical prosthetic device manufacturer in developing a cooperative research agreement with the Walter Reed Army Medical Center and Department of Veterans Affairs, including securing federal funding to support the project.  Sonnenschein assisted the client with partnership initiatives and sponsorship opportunities with voluntary health associations in the amputee and disability communities. On behalf of a medical device manufacturer, Firm attorneys analyzed the fraud and abuse implications of an arrangement pursuant to which the manufacturer would offer one item at no separate charge provided the supplier purchased another item at designated volumes and prices.

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Physicians & Physician Groups

Sonnenschein attorneys represented a multi-specialty physician group in connection with a government investigation of managed care contracting practices.  Sonnenschein attorneys represented a corporate provider of laser eye surgery services in a merger transaction valued at nearly $100 million.  Firm attorneys counseled a group of cardiologists in connection with their relationship with a large hospital that had a regional heart center, for the management of hospital’s cardiac services line.  Firm attorneys counseled medical providers regarding the structure of, and participation in, a provider network On behalf of a not-for-profit health system, Sonnenschein attorneys structured the affiliation between one of the system’s hospitals and a large multi-specialty medical group.  This matter involved the extension of a subordinated loan facility to the medical group to satisfy the solvency requirements of its provider-sponsored health maintenance organization, and the negotiation of equity participation by the hospital in the medical group.  Sonnenschein attorneys represented a not-for-profit hospital in the development of a joint venture heart hospital with approximately 75 local cardiologists and cardiovascular surgeons.  This representation involved the preparation of a comprehensive offering memorandum (identifying investment, business, governmental, and tax risk factors) for distribution to potential investors. Sonnenschein assisted a teaching hospital in restructuring its cardiovascular surgery program, which involved recruiting a nationally recognized cardiovascular surgeon to assume the role of chair of the newly created cardiovascular services department and negotiating and drafting the medical director agreement, professional services agreement, and other ancillary agreements between the surgeon, his professional corporation, and the hospital. Sonnenschein attorneys represented a teaching hospital in a joint venture with oncologists to form a limited liability company (1) to purchase state-of-the-art equipment, including PET/CT scanners, linear accelerators and other equipment used in the diagnosis and treatment of cancer and (2) to lease that equipment to the hospital for use in its cancer center. On behalf of one of the nation’s most prestigious health systems and three of its hospitals (one of which is a prominent teaching hospital), Sonnenschein attorneys reviewed and analyzed dozens of arrangements between and among the health system, hospitals, medical groups under contract with the hospitals, and scores of physicians affiliated with these medical groups under Federal and State anti-kickback, physician self-referral, and reassignment laws.  On behalf of a hospital, Firm attorneys reviewed and analyzed a proposed joint venture between the hospital and various physicians to develop and operate an ASC under Federal and State anti-kickback and physician self-referral laws.  Sonnenschein has represented numerous hospitals (as well as other providers and suppliers) in Medicare overpayment disputes and audits involving fiscal intermediaries and carriers.  For example, Sonnenschein attorneys worked with a large community mental health provider to reduce a $1 million overpayment demand to less than $40,000.  On behalf of a medical professional society, Firm attorneys have worked closely with the HHS OIG, CMS’ Program Integrity Unit, and the Medical Directors of several Medicare Part B carriers on a variety of coverage, reimbursement, local medical review policy, and anti-kickback law issues. Firm attorneys successfully represented two academic medical centers under investigation as part of the Federal government’s Physicians At Teaching Hospitals (PATH) initiative.  On behalf of a large health system client, Sonnenschein is involved in the class action antitrust lawsuit filed by several medical residents against various hospitals and medical schools that sponsor residency programs, as well as several medical organizations, such as the American Association of Medical Colleges, the American Hospital Association, the American Medical Association, and the National Resident Matching Program.  The lawsuit alleges that the match of medical students to residency programs, the accreditation rules for residency programs, and several surveys of resident stipends/benefits were part of a conspiracy to reduce the stipends and other benefits provided to medical residents in violation of antitrust laws.  Firm attorneys have developed policies and procedures for various health care providers in preparation for JCAHO, NCQA, and contracted health plan surveys.  On behalf of hospitals and other providers, Sonnenschein attorneys have performed legal assessments of disciplinary and deficiency allegations, responded to inspection and survey reports, and challenged inspection and survey findings.  Sonnenschein attorneys have conducted comprehensive facility-wide surveys and recommended courses of action to resolve identified deficiencies in Medicare Conditions of Participation, State licensing regulations, JCAHO, NCQA and other applicable standards.  Sonnenschein attorneys represent nonprofit hospitals and their medical staffs in drafting, updating, revising, and interpreting medical staff bylaws. The firm represents nonprofit hospitals and their medical staffs in advising and defending physician peer review and disciplinary matters and investigations. Health care attorneys assist hospitals in drafting conflict of interest policies addressing ownership interests by medical staff members in competing specialty hospitals or ASCs.  Conversely, attorneys advise physicians and physician groups on the reasonableness and appropriateness of such polices as applied to them. Sonnenschein advises hospitals as to the legality, under the Federal anti-kickback and Stark laws, of providing temporary assistance to members of the medical staff in obtaining professional liability insurance in States experiencing severe access or affordability problems. On behalf of two hospitals preparing for upcoming JCAHO accreditation review, Sonnenschein attorneys updated the medical staff bylaws to incorporate recent accreditation medical staff standards revisions. Firm attorneys provided assistance to a hospital that found it necessary to summarily suspend a medical staff member’s surgical privileges based on imminent danger to patients.  As part of this representation, Sonnenschein assisted the hospital administrators and medical staff officers and committees in meeting the procedural requirements of the bylaws, including providing notice to the physician, conducting the suspension hearing and review process, and reporting the outcome to the National Practitioner Data Bank and State licensing agency. Sonnenschein attorneys assisted an ambulatory surgical center and its medical staff officers and committees in conducting a peer review investigation into a surgeon’s high complication rate.  Sonnenschein advised nonprofit hospitals and clinics regarding obligations and alternatives for emergency room on-call coverage by their medical staffs and physician contractors. Firm attorneys advise hospitals with regard to closures of hospital services or departments, including notice and comment and related administrative-type hearings, and review of hospitals’ obligations to the members of medical staff.  Sonnenschein advises hospitals with regard to medical staff organization and structure in connection with hospital mergers and affiliations. On behalf of a dental practice management company with dental centers located in four States, Sonnenschein prepared marketing guidelines summarizing applicable Federal and State regulations governing the marketing and advertising of dental services.  Our attorneys counseled a health care provider regarding the interplay of State and Federal fraud and abuse laws, State licensing laws, State corporate practice of medicine laws, and State law restrictions on professional fee splitting.  Health care attorneys represented a medical group in connection with a settlement with an entity controlled by a tax-exempt organization.  Representation included coordination with an independent appraiser to establish and document compliance with tax-exemption standards regarding the fair market value of the exchange between the tax-exempt entity and the separating physicians.  Practice Group attorneys represented a tax-exempt hospital with respect to tax-exemption issues arising in connection with the provision of professional courtesy discounts to physicians and other members of hospital.  Sonnenschein represented a tax-exempt hospital system in connection with the development and implementation of policies and procedures governing compliance with tax-exemption requirements including those relating to physician recruitment and approval of transactions with “insiders.”  Sonnenschein attorneys have drafted and negotiated business associate agreements for numerous providers, health care clearinghouses and health plans.

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Professional Societies & Trade Associations

We advised a Medical Society in connection with its role in facilitating dialog between a major insurer and local physicians concerning managed care contracting.  Sonnenschein attorneys assisted a trade association of hospitals and health systems in revising its corporate governance policies to reflect the principles of corporate responsibility set forth in the Sarbanes-Oxley Act of 2002, including the development of a Code of Ethics for senior financial personnel and a whistleblower protocol. On behalf of a medical professional society, Firm attorneys have worked closely with the HHS OIG, CMS’ Program Integrity Unit, and the Medical Directors of several Medicare Part B carriers on a variety of coverage, reimbursement, local medical review policy, and anti-kickback law issues. On behalf of a large health system client, Sonnenschein is involved in the class action antitrust lawsuit filed by several medical residents against various hospitals and medical schools that sponsor residency programs, as well as several medical organizations, such as the American Association of Medical Colleges, the American Hospital Association, the American Medical Association, and the National Resident Matching Program.  The lawsuit alleges that the match of medical students to residency programs, the accreditation rules for residency programs, and several surveys of resident stipends/benefits were part of a conspiracy to reduce the stipends and other benefits provided to medical residents in violation of antitrust laws.  At the request of three major health insurance associations, Sonnenschein attorneys conducted a nation-wide preemption analysis under the HIPAA and State privacy laws affecting insurers and health care providers.  Sonnenschein attorneys provided antitrust and other regulatory counseling to a State association of medical groups.  On behalf of a national physician specialty association, Sonnenschein attorneys provided policy and other guidance regarding regulatory issues affecting association members.  On behalf of a national insurance association, Sonnenschein attorneys provided regulatory advice on issues of interest to association members and advocated for improvements in enforcement activities undertaken by the Centers for Medicare & Medicaid Services. The Firm represents a national high profile cancer foundation in the development of a national health plan for cancer — including elements of research and development, detection and prevention, treatment and survivorship issues.  Sonnenschein assisted the foundation in the development of authorization legislation, Federal appropriations, and Congressional relations, including high profile meetings and events with Senators, Members of Congress, and the White House in support of the client’s agenda. Sonnenschein serves as general counsel to a leading health information technology association comprised of both vendors and providers.  In this capacity, Sonnenschein provides general corporate, tax counsel, employment advice and public policy assistance.

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