Prepared an amicus brief on behalf of the American Hospital Association in support of the U.S. Department of Health and Human Services (HHS) interpretive rule providing guidance on the scope of the exclusion of orphan drugs from 340B discounts.
Health Care Law
With one of the largest health care practices in Ohio and the nation, we address the wide range of critical legal needs facing today’s health care systems and providers.
Legal and regulatory challenges are a reality for today’s health care providers. With the aging population and rising costs, the industry is in the midst of a critical turning point, and compliance and efficiency are more important than ever before.
Our firm recognizes the importance of a thriving health care industry. For more than 60 years, we have maintained a broad and varied health care law practice, now one of the largest health care practices in the state as well as the nation. Our longstanding, established practice reflects our dedication to serving hospitals and health systems as a partner, not just legal counsel.
As a group and as individuals, our health care attorneys are highly regarded by clients and peers. They are known for their knowledge of our clients’ businesses and the unique and complex policy, regulatory and business issues they face. Our diverse team has firsthand regulatory, compliance and clinical experience in the health care industry and includes several members who have served as in-house counsel, practice managers and practitioners in health care environments.
Recent rankings and recognitions include:
- "Modern Healthcare" magazine has cited Bricker & Eckler as one of the 35 largest health care practices 2010-2014
- Bricker & Eckler Health Care group ranked as Band-1 Ohio by Chambers USA 2011-2014
- 11 health care attorneys listed in Best Lawyers in America in 2015
- 10 health care attorneys listed in Ohio Super Lawyers in 2015
Bricker & Eckler has significant experience in all aspects of health care law, including:
- Clinically integrated organizations and accountable care organizations
- Physician-hospital alignment and integration
- Stark, Anti-Kickback, and fraud and abuse
- Health information technology, electronic health records and health information exchange
- HIPAA and health information privacy and security
- Managed care and insurance
- Health care antitrust
- Survey and certification, provider enrollment, accreditation and licensure
- Employment and labor
- Corporate governance
- Mergers, acquisitions, joint ventures and physician practice acquisitions
- Medicare, Medicaid and reimbursement
- Medical staff organization, credentialing and peer review
- Tax and tax-exemption
Related Industries & Practices
Hospitals, health care facilities and individual providers must comply with state, federal and other certification, accreditation and licensure requirements. Because these rules are varied, complex and continuously evolving, our attorneys navigate the requirements, inform facilities and practitioners of their continuing obligations and help them think strategically and operationally about their certification, accreditation and licensure challenges. We also assist organizations undergoing surveys, helping them navigate the survey process, respond to notices of deficiencies and develop plans of correction. For more information, please visit our Certification, Accreditation & Licensure page.
A number of our attorneys' practices focus on fraud and abuse laws, specifically the Stark Law, the Anti-Kickback Statute, the Civil Monetary Penalties Law, the Overpayment Statute, the False Claims Act and qui tam actions. We are skilled at structuring arrangements and transactions to comply with these laws and reviewing proposed transactions and arrangements to identify possible problem areas. We stand by our clients in responding to and defending against audits, investigations and qui tam actions, and we assist with voluntary disclosures, advising our clients once they become aware of a potential violation. For more information, please visit our Compliance, Fraud & Abuse page.
To remain competitive in the dynamic world of health care delivery, health care providers must grow their facilities, enhance their service lines, change strategic direction, or expand into new delivery systems through joint ventures, mergers, practice and facility acquisitions and divestitures, corporate reorganizations, partnerships and other integration-oriented transactions. Whether engaging in a single transaction or a long-term strategic plan with many related transactions, our firm helps health care businesses position themselves for success. In an ever-evolving healthcare marketplace we craft a thoughtful and creative approach to addressing the complex array of health care rules and regulations that inevitably arise in connection with these transactions. For more information, please visit our Health Care Transactions page.
In an era of data breach headlines and increased enforcement, it takes more than a set of policies to protect sensitive patient medical information. An ongoing risk assessment and well-developed strategy for privacy and security is a must-have for any health care entity. Implementing and maintaining electronic health record systems and managing a health information exchange are critical functions for today’s health care providers, with costly consequences for noncompliance. We are a nationwide leader in comprehensive legal services related to HIPAA and the privacy and security of patient information and have even established renowned online programs to help our clients enhance compliance. We work with health care entities to assist with electronic health record issues, including meeting meaningful use requirements and responding to meaningful use audits. Our attorneys are known nationwide for working closely with industry pioneers in the rapidly evolving field of health information exchanges. For more information, please visit our HIPAA & Health Information Technology page.
Employees are the lifeblood of a thriving health care facility. To maintain a happy and productive work environment, health care employers seek to minimize employment-related issues and prepare to quickly address any problems that do arise. From providing guidance on employment policies and benefits to defending employers in legal actions, we blend employment knowledge with health care experience to give proactive legal advice and build creative solutions for our health care employers. For more information, please visit our Health Care Employment & Labor page.
Our health care litigation team is uniquely qualified to handle medical negligence and wrongful death claims for hospitals, physicians and other medical providers. Not only do the attorneys at Bricker & Eckler have extensive experience defending medical claims in the courtroom, whether they are conducting a jury trial, arguing to various appellate courts or arguing before the Ohio Supreme Court, but they also have immediate access to the substantive experience of the Health Care group. We are able to provide among the most comprehensive representation of hospitals and medical providers available anywhere in Ohio. For more information, please visit our Health Care Litigation page.
The hospital-physician relationship is multifaceted and important to the future of patient care. As health care systems grow, so do their relationships with physicians, raising a number of legal issues related to independent physicians, employed physicians and medical staffs. Often collaborating with our employment attorneys, we work with health systems to plan for and address these legal issues, including medical staff and advanced practice provider governing documents; medical staff integration; sharing protected information; credentialing; quality assessment, performance improvement and peer review processes in both the hospital and employment setting; and recruiting and contracting. For more information, please visit our Physician & Medical Staff Issues page.
Often, a significant portion of a provider’s revenue depends on Medicare and Medicaid reimbursements. Working with the Centers for Medicare & Medicaid Services (CMS) to manage claims and comply with their ever-changing requirements can be a complex process that drains time and resources. We continuously monitor CMS communications and other developments and collaborate with our health care clients to notify them of the latest statutes, rules and regulations – and their implications – for the clients’ continued success. When necessary, our attorneys help our clients prevent and solve any compliance issues or reimbursement disputes. For more information, please visit our Medicare, Medicaid & Managed Care page.
Because health care is one of the most regulated industries in the U.S., health care providers must tirelessly navigate the patchwork of state and federal regulations that governs nearly all aspects of their operations. From insurance reimbursement to the administration of medications to referrals, our attorneys work with administrators to ensure their facilities and their staffs avoid the traps of noncompliance in both day-to-day operations and long-term strategies. With our familiarity and ongoing analysis of current health care laws and regulations, we regularly assist hospitals and health care facilities in overcoming regulatory challenges and advocating policy changes to further their goals. For more information, please visit our Health Care Regulatory page.
Assisted in the development of a state-wide database for health care information reports, including the creation of policies and agreements and compliance with regulatory requirements (including HIPAA). Also worked to revise protocols for state-to-state relationships, the sharing of data and related data sharing agreements.
Assisted a large health system with the system-wide implementation of an electronic health records (EHR) system, ensuring legal and regulatory compliance, HIPAA security and continuity of patient care.
Represented a county hospital that became affiliated with a large health care system, obtaining all regulatory approvals, overseeing self-disclosure of potential Stark issues and assisting with the payoff of outstanding bonds.
Provided corporate regulatory advice in connection with the formation of a statewide network of six regional health care systems, which was one of the largest health care joint ventures in our country’s history.
Advised a public hospital regarding its response to a series of requests for a large number of public records.
Assisted with transitioning all assets of a not-for-profit developmental disability service provider to another not-for-profit developmental disability service provider, forming one of the largest developmental disabilities service providers in Ohio in terms of revenue and consumers served.
Developed a peer review process for physicians employed by hospital-affiliated entities and created documents that permitted the sharing of peer review information between the hospital and the affiliated entity.
Assisted hospitals with responding to meaningful use audits by the Centers for Medicare & Medicaid Services (CMS) on its electronic health record incentive payments, which required analyzing compliance with regulatory requirements for receiving such payments.
Successfully defended a qui tam action brought under the False Claims Act on behalf of a hospital system who was alleged to have violated the Health Information Technology for Economic and Clinical Health (HITECH) Act by improperly certifying its compliance with the HITECH Act in exchange for receiving meaningful use payments.
Successfully defended a hospital and its employees in a jury trial case where a patient's estate claimed that the patient had received deficient care and had been discharged from the hospital prematurely. The patient's estate claimed that the patient died from a massive internal bleed that additional hospitalization would have prevented. Following a week and a half trial, the jury returned a defense verdict.
Represent large teaching hospitals and other non-teaching hospitals on Medicare reimbursement matters and cost report appeals, which include appeals of administrative agency decisions and various court appearances.
Negotiated a settlement of Medicare reimbursement underpayments with the federal government on behalf of two large health systems.
Prepared and filed the application for licensure in Ohio, obtaining approval of the application. Coordinating with counsel from other states, we also advised the client on a number of strategic issues.
Acted as borrower's counsel for a municipal hospital in the issuance of $35 million in revenue bonds.
Represented governmental hospital and acted as borrower's counsel in $25 million hospital revenue bond financing, successfully negotiating a unique provision that permitted the hospital to convert to private nonprofit status in the future without having to obtain the consent of the bondholders.
Served as lead counsel in the acquisition of a nonprofit health system by a health corporation, negotiating the transaction, drafting all corporate documents, conducting due diligence review and completing all regulatory filings.
Served as counsel to the Ohio Health Information Partnership and assisted with all aspects of its operation of a health information exchange (CliniSync).
Represented a hospital in overturning disallowance of residents in IME count based on nature of residency program activities.
Advised hospitals on potential False Claims Act exposure; also represented the Ohio Hospital Association and the American Hospital Association in successfully challenging the government's use of the False Claims Act in Ohio's laboratory unbundling litigation.
Represented a hospital in ordering the government to update reasonable compensation equivalent (RCE) limits.
The HIPAA Resource Center provides links to the statutes, regulations and various other HIPAA related resources, as well as our subscription HIPAA Privacy and Security Compliance and Audit Program. For more information, please visit our HIPAA Resource Center.
This resource center sets forth the statutes, regulations and other documentation regarding Medicare and Medicaid fraud and abuse. Information includes the Stark anti-referral requirements and general anti-kickback information. For more information, please visit our Medicare/Medicaid Fraud & Abuse Resource Center.
Employed physician arrangements in the government's crosshairs
CMS finalizes new exceptions and clarifications to Stark Law
Budget Bill Blues: The reimbursement equalization of hospital off-campus provider-based locations and independent health care facilities
In-depth summary of Stage 3 Meaningful Use and CEHRT rules
The HIPAA Audit and Compliance Program is a comprehensive on-line program for complying with the HIPAA privacy, security and breach regulations, including the provisions of the HITECH Act and the Omnibus Rules issued in January, 2013.
The Quality Management Consulting Group (QMCG), in conjunction with Bricker & Eckler, has developed this program to help hospitals identify all areas of provider-based compliance and to give you the tools you need to be and remain in compliance. Through this resource, you are able to put together an attestation to submit to CMS if desired.