Pitch Supplement - Experience in Subfields



Experience in Subfields

Accreditation (the Joint Commission)/Surveys/Certification

For many of our clients, obtaining and maintaining accreditation by the Joint Commission is a top priority. Our attorneys understand the critical need to maintain high standards of compliance and are experienced in navigating the issues institutions face when applying for accreditation. Our healthcare team has provided advice and counseling to hospitals after recommendation by the Joint Commission of preliminary denial of accreditation or conditional accreditation as well as reviewed and prepared policies and procedures to comply with new Joint Commission initiatives such as Focused and Ongoing Professional Practice Evaluations (FPPE, OPPE), conflict management policies, and telemedicine. We also assist in preparing corrective action plans.

Antitrust

Venable attorneys are highly experienced in the full range of antitrust matters, including mergers and acquisitions, advocacy before antitrust law enforcers, representation in government investigations, and antitrust litigation. Our attorneys served in the Antitrust Division of the Department of Justice, at the Federal Trade Commission, as Assistant United States Attorneys handling antitrust litigation, and in state attorney general offices.

Venable represented a multi-national vertically-integrated healthcare provider and insurer in a complex antitrust investigation brought by the U.S. Department of Justice for potential Sherman Act violations involving an alleged conspiracy to restrict healthcare competition. Venable succeeded in getting the three-year investigation closed without any action against its client.

Venable is currently defending a global pharmaceutical company in several high-profile private class actions for alleged antitrust violations stemming from its pharmaceutical patent litigation settlements, and has defended these same settlement agreements before the Federal Trade Commission. These so called "pay for delay" cases are a critical antitrust enforcement priority for the FTC. Venable's antitrust team is also currently representing a large multi-national pharmaceutical company in a state attorney general investigation involving allegations of a market allocation scheme. Also in the healthcare arena, we currently serve as antitrust counsel to a consortium of large pharmaceutical companies, working to ensure compliance with the antitrust laws on all conduct involving the consortium.

Venable's antitrust team is replete with experience, including defending dozens of antitrust investigations before antitrust law enforcers. The Venable team includes the antitrust attorney advisor to the former chairman of the FTC, Jon Leibowitz, whose antitrust agenda was focused largely on healthcare. 

Venable's antitrust attorneys routinely counsel clients on confidential antitrust matters in the healthcare arena including antitrust analysis of potential mergers and acquisitions and joint ventures, and key strategies to ensure those transactions pass DOJ and FTC antitrust scrutiny. We also counsel clients on distribution practices, interactions with competitors, and much more.

Biomedical Research/Clinical Trials

Venable has a depth of knowledge in clinical trial matters. We have counseled clients on a broad range of issues related to clinical trials, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and other regulatory restrictions on participants' privacy; developing and reviewing informed consent protocols and forms of study participants; on behalf of and with clinical research organizations, negotiating the form and substance of clinical trial arrangements; reviewing and modifying Institutional Review Board (IRB) policies and procedures, analyzing the benefits and disadvantages of establishing a new IRB or contracting with national IRBs; negotiating on behalf of subcontractors in clinical trials funded in part with federal funds to ensure compliance with federal grant-making rules; and providing counsel to IRBs on how to address conflicts of interest posed by physicians and investigators; compassionate, emergency, and treatment INDs (investigational new drug exemptions granted by FDA); clinical holds, clinical investigator disqualification by FDA, and investigations of clinical investigators by FDA and by the Department of Justice; FDA conflict of interest standards and remuneration of clinical investigators; and FDA inspections of clinical investigation sites. We have also negotiated and drafted sponsored research agreements, material transfer agreements, and other arrangements that are an integral part of biomedical research collaborations with academic medical centers.

Because of our experience and familiarity with the diverse and nuanced nature of this work, we understand the varying constituencies and their respective motivations and constraints in working through the complex regulations and business issues involved in clinical trials and biomedical research.

Clinical Laboratories/CLIA

Venable is well equipped to help clients navigate the patchwork of state and federal regulations regarding the operation of clinical laboratories in the United States. Venable has assisted clients in applying for CLIA certification, certificates of waiver, and changes of ownership. We have advised hospitals, physician groups, national laboratory companies, suppliers, and wellness companies on a broad variety of clinical lab issues, including CLIA compliance, reimbursement issues, state licensure and permitting, litigation, and Stark issues.

Conflict of Interest/Transparency (Clinical Operations and Research)

Venable has broad experience in handling conflicts of interest issues regarding physicians, governing boards, and hospitals. We regularly advise on conflict of interest and transparency issues and draft conflict of interest policies to minimize any potential exposure our clients may have to challenges to the relationships between their boards, physicians, and other entities. We have drafted conflict of interest policies for governing boards of non-profit hospitals, as well as policies for medical staff members and leadership with ownership interests in competing hospitals and surgical practices.

Faculty Practice Plans

Venable's healthcare attorneys understand the integral part faculty practice plans play in the businesses of academic medical centers. These plans can raise a number of issues, including governance, financial arrangements, compensation, fraud and abuse, tax and IP. We have reviewed and drafted faculty practice plans for clients, and are able to provide practical advice with regard to the plans while considering the many legal issues that accompany them.

Federal Contracts

Venable has extensive experience representing clients who provide products and services to federal, state and local governments. We take an integrated approach to the delivery of legal services related to government contracting that enables us to provide comprehensive legal advice and handle transactional matters covering the many diverse and highly technical issues that affect clients doing business with the government. Our attorneys counsel clients on the full range of issues that may confront the University, including, but not limited to, cooperative agreements, cooperative research and development agreements, grants, and other transactions; contract claims disputes, litigation and ADR; international contracting/foreign content; cost and pricing; false claims act lawsuits; government information law, including the Freedom of Information Act and Privacy Act: Government-Wide Acquisition Contracts including GSA Schedule contracts; bid protests; bid protests; compliance/ethics programs; information technology procurements (including GSA Schedule); intellectual property; homeland security issues, SAFETY Act protection and other unique requirements; investigations, criminal defense, suspension and debarment/exclusions; defense of OIG audits/investigations of Universities and Health Care Facilities; business systems reviews; privatization and outsourcing; small business matters; prime/subcontracting relationships; joint ventures and teaming agreements; and other issues.

Fraud and Abuse

Venable's healthcare attorneys provide advice, counseling and litigation support. We have extensive experience in drafting and implementing compliance plans and advising clients on all aspects of compliance with federal and state fraud and abuse statutes, including False Claims Act, Civil Monetary Penalties Act, Anti-Kickback and Stark statutes. We represent clients facing enforcement actions by federal and state agencies, as well as by the various regulatory bodies.

Our experience includes advising multiple hospitals, physician groups, ASCs, nursing homes, HHAs, DME suppliers, and pharmaceutical companies on a variety of Stark/False Claims Act/Anti-kickback issues, representing several health systems in OIG enforcement actions, including false claims and qui tam actions, and conducting investigations on non-compliance. We have prepared and filed several Stark self-disclosures with CMS under the SRDP protocols.

Governance (Healthcare Entities)

Part of what makes a successful healthcare organization is its governing body's ability to implement procedures and policies that ensure compliance with state and federal laws regarding governance issues including fiduciary duties, management agreements, and professional services agreements.

Venable has broad experience in this area of law, including but not limited to advising a Medicaid HMO owned by a large teaching hospital and community health centers on governance issues. Our attorneys have also prepared and delivered management and fiduciary duty standards, systems, policy papers and presentations on corporate governance and restructuring for multi-corporate nonprofit systems, including a $1 billion teaching hospital in California and a $1 billion health system in the Midwest. Venable regularly conducts corporate governance review for its hospital clients.

Graduate Medical Education

Venable is experienced in advising clients on matters regarding their graduate medical education programs, which can pose unique and complex legal issues. Venable's lawyers understand the importance of maintaining program integrity while minimizing liability. Venable has advised teaching hospitals with regard to the accreditation of graduate medical education programs, including appealing denials or restrictions of accreditation. Additionally, Venable has assisted clients in developing programs in connection with challenges of residents who have been dismissed or disciplined under the graduate medical education program.

Health Care Reform/Accountable Care Organizations

Now that national healthcare reform has become a reality, the health insurance market is changing dramatically and change will continue for the next few years. Venable is uniquely positioned as an advisor to clients on healthcare reform both because of its proximity to CMS in Baltimore and other agencies in Washington DC and because of its connections within the political community. In particular, former U.S. Congressman Bart Stupak, who played a key role in the passage of the Affordable Care Act, provides valuable advice and insight to the firm as a member of Venable's Legislative and Government Affairs group.

Venable is working with clients in helping to evaluate all of the options available to them, so that they are able to make the right choices that are in the best interests of their organizations and employees. But, even in the wake of national healthcare reform, health insurance plans for employees remain a highly valued benefit. We have advised organizations, including a large Blue Cross Blue Shield Plan, about the insurance exchanges, HIPAA, COBRA, mental health parity, GINA, and regulatory developments affecting the design and structure of health and welfare plans, and have worked with organizations to structure retiree health obligations and take advantage of potential subsidy programs.

In the months following the Accountable Care Act, accountable care organizations (ACOs) and other forms of managed care became, and are continuing to become, more prevalent. Our clients rely on our ability to keep up to date with the latest regulations and news regarding these organizations in order to help them make the best decisions going forward in light of this comprehensive reformation of healthcare law and reformation. For example, Venable recently advised a 100-plus physician group in the formation of an HMO and eight certified Medicare ACOs.

Health Information Technology/Privacy/Security

Our attorneys understand the diverse and complex issues that face healthcare clients with regard to privacy and electronic data security. Our attorneys are at the forefront of this developing area of law and have been involved in drafting the major statutes and regulations in the field. Venable has a well-established Privacy and Data Security practice that earned special recognition from Chambers USA when the firm was selected for the 2009 Award for Excellence in this area of law.

Venable has extensive experience in representing health entities in contract negotiations with software vendors and firms for the implementation of new compliant health information systems as well as helping health systems implement ehealth programs, including drafting licensing and other agreements with participating physician groups. Venable also regularly drafts and negotiates hundreds of business associate agreements and HIPAA compliance plans and policies. Our highly knowledgeable attorneys frequently speak and publish on HIPAA.

Although the law is still developing, it is critically important for organizations that venture into social media and social networking to seek counsel as their involvement in the virtual world deepens. With UC’s healthcare-related online activities, the University may be exposed to potential risks. We can assist in avoiding undue risk related to medical privacy regulations, and electronic data and communications security in online social media and social networking.

Licensure/Enrollment (Provider and Physician Supplier)

Venable attorneys are experienced in assisting with state and federal licensure and enrollment issues for healthcare providers and physicians. We regularly assist clients in their initial Medicare/Medicaid enrollment applications and any subsequent changes a client may need to make. We have also handled licensing issues for many different healthcare providers including hospitals, physicians, nurses, nursing homes, assisted living facilities, pharmacies, ambulatory surgery centers, and home health agencies.

Managed Care Contracting/Knox Keene

Our attorneys are well versed in representing managed care programs. Our experience includes representing a $1 billion health maintenance organization, as well as Medicaid and Medicare managed care organizations, representing combinations of physicians and hospital entities in forming contracting entities to participate in managed care arrangements, and representing a major teaching hospital in a dispute with a large, publicly traded health insurer over the sale of an HMO. We also advise physician groups in the formation of managed care organizations, including HMOs and ACOs.

In addition, Constance Baker has served as a guest lecturer in managed care at the Johns Hopkins School of Medicine, Business of Medicine program, and has negotiated managed care contracts for physicians and other healthcare professionals.

Medical Staff/Credentialing/Peer Review

Our attorneys provide advice and counseling to numerous hospitals regarding appropriate procedures for investigation of complaints regarding physicians and conduct of hearings and appeals (and creative alternatives) regarding suspension and termination of medical staff privileges, in matters such as inappropriate use of cardiac stents, performance of peripheral endovascular interventional procedures without appropriate training, failure to adhere to standard of care in performance of vascular surgical procedures, false entries in medical records and disruptive behavior of physician toward staff and other hospital personnel. We also provide advice to hospitals regarding reporting obligations to state licensing boards and the National Practitioner Data Bank (including their different requirements) and revise Medical Staff Bylaws, Rules and Regulations, Fair Hearing Manuals and Credentialing Manuals to streamline procedures and to comply with changing JC and CMS requirements and compliance obligations.

Pharmacy Regulation/Reimbursement

Venable partner Peter P. Parvis has assisted pharmaceutical manufacturers in complying with 340B requirements, including pricing and reporting requirements and contracting with wholesalers. Mr. Parvis also has assisted several pharmaceutical manufacturers in assessing the issues surrounding the decision to participate in the Medicaid Drug Rebate Program, which necessitates participation in the federal purchasing program administered by the Veteran’s Administration and participation in the 340B program.

Our attorneys also have experience with representing one of the three largest pharmacy chains in numerous matters, including the congressional “marketing the spread” investigations that led to the AWP lawsuits and a FTC investigation into mail order pharmacy activities of pharmacy benefit manufacturers, and negotiations/audits with PBM. 

Reimbursement (Provider and Physician Supplier)

Venable is well versed in federal and state Medicaid and Medicare regulatory issues and general contract terms associated with private payor or reimbursement contracts. We work closely with CMS, which is located just a few miles away in Baltimore, MD. A former high-level CMS executive has joined our healthcare group. We have counseled clients on a wide range of issues related to the Medicare and Medicaid payment programs, including extensive work on ways of lawfully maximizing reimbursement in various situations (such as joint ventures and corporate restructuring) and administrative reviews of judicial appeals. Venable has dealt with certification, conditions of participation, coverage, reassignment and other government reimbursement issues for all types of government certified providers. Venable closely monitors the changes in the laws that influence or affect our healthcare clients. As such, we are able to work with clients to ensure that they comply with the maze of regulations that dictate how they manage daily operations, billing procedures, purchasing mechanisms, and other key functions. When needed, we have the depth and experience to defend clients in criminal, civil and administrative proceedings with the government or private payors that stem from reimbursement contract disputes, and counsel them in audits or investigations by government payors.

In addition, our attorneys are experienced in various other aspects of Medicare and Medicaid, including negotiating deficiencies in Conditions of Participation for healthcare providers; negotiating with HHS/OIG regarding exclusion of healthcare providers from Medicare and Medicaid; negotiation of termination notices for alleged violations, and negotiations for alleged violations of the Emergency Medical Treatment and Labor Act (EMTALA), including negotiations with the Office of Inspector General regarding civil monetary penalties and fines for violations of EMTALA.

Research Administration/Grants/Finance/Grants Policy

Venable has long been active in public and bond finance. Our clients include healthcare providers (ranging from internationally prominent hospitals to independent nursing homes), educational institutions (including colleges, universities and private schools) and various other tax-exempt organizations, as well as owners of exempt facilities both large (such as coal gasification plants and electric cogeneration facilities) and small (such as small manufacturing facilities). For example, Venable serves as lead counsel to a large medical center in matters related to financing, bond allocations, and bond issuances. Recently, Venable attorneys structured a tax-exempt refinancing of short-term bank supported debt and other outstanding debt to long-term, tax-exempt fixed rates together with additional borrowing to support facility improvements. Venable represented the nation’s largest health insurer in its investment in a limited partnership.

Venable acts as lead counsel for a large retirement community in matters such as bond issuances and management, marketing and development agreements. Recently, Venable advised the client in connection with proposed issuance of approximately $150 million of Massachusetts Development Finance Agency tax-exempt revenue bonds in connection with proposed tender offer for exchange with outstanding 2007 bonds for a continuing care retirement community, coupled with potential pre-packaged bankruptcy filing for the community. Venable was also counsel to a regional medical center in connection with a $142M in financing for major renovation and expansion. Financing included an issuance of tax-exempt hospital revenue bonds and derivative agreement to provide hospital with lowest cost of capital.

Venable's Government Contract's practice group has extensive experience in advising and representing tax-exempt and for-profit clients with respect to compliance with requirements under government contracts and grants, including subcontracts and sub-awards under government prime contracts and grants. We have assisted many tax-exempt organizations in assessing whether they have the appropriate policies and internal controls in place to avoid many of these requirements. Similarly, we have advised numerous tax-exempt organizations and for-profit companies on whether their proposals and grant applications are compliant with mandatory provisions of solicitations and grant announcements. Venable also has assisted tax-exempt organizations, specifically, in complying with the cost principles imposed upon nonprofits and other tax-exempt organizations under OMB Circular A-122 (Cost Principles Applicable to Nonprofit Organizations) as well as with record retention and audit requirements under OMB Circular A-133. We also can ensure that any further sub-awards that UC might make to independent consultants or other entities include all of the provisions that are required “flow down” to these organizations under the terms of UC’s subcontract and sub-award documents. We have drafted subcontracts and sub-awards to ensure compliance with, and incorporation of, government contracts and grant requirements for a number of tax-exempt organizations.

Tax

Venable has a dedicated tax practice with more than 40 attorneys focused on tax issues, including attorneys formerly with the IRS Office of Chief Counsel and the Joint Committee on Taxation, as well as a former tax counsel for the Senate Finance Committee and legislation counsel for the Joint Committee on Taxation, a former tax counsel for the Senate Finance Committee and a former trial attorney for the U.S. Department of Justice, Tax Division. Some of our attorneys have “Big Four” accounting firm experience, and many are certified public accountants or have advanced degrees, such as a Master of Law in Taxation or a Master of Business Administration. The backgrounds of our tax attorneys have proven to be tremendously helpful in navigating the intersection of tax policy and enforcement, legislation and regulation. Our tax attorneys are nationally recognized in their field and many are listed among the Best Lawyers in America.

Venable's tax attorneys handle a range of issues – from general corporate advisory work such as acquisitions, mergers and joint ventures, to tax controversy work including large case audits and litigation, to matters related to personal wealth planning, employee benefits and executive compensation, and international tax matters. We provide sophisticated tax planning to large and small businesses, individuals and nonprofit organizations.

We regularly engage in contested proceedings before the Internal Revenue Service, the U.S. District Courts, the Tax Court, the Claims Court, and many state tax agencies. We represent public corporations and private business entities as well as high-net-worth individuals at every stage of resolving disputes with the Internal Revenue Service and state tax agencies, including audit examinations, tax and audit appeals and, when necessary, tax litigation. We also have been successful in employing IRS alternative dispute mechanisms, such as Fast Track mediation and settlement. Several Venable tax attorneys began their careers at the IRS, representing the government in significant tax controversies and litigation, which provides experience and familiarity with IRS procedures and guidelines to the benefit of Venable's clients.

A particular strength is tax advice and counseling for business transactions. We are highly skilled in complex business transactions including stock and asset transactions, corporate mergers, the creation of joint ventures, like-kind exchange transactions, tax treatment of real estate investment trusts, taxation of condominiums and cooperatives, and low-income housing credit transactions. We also represent clients in state and local income tax matters, and matters concerning recordation and transfer taxes and real property tax exemptions. In addition, we advise clients concerning the avoidance of tax disputes, disclosure matters, and related civil and criminal tax issues.

Venable's tax attorneys review all tax opinions and supervise the preparation of all tax documentation for Venable’s bond counsel engagements. This ensures that our clients receive a consistent approach to tax issues.

Transactions/Affiliations

Venable's healthcare transactions team includes partners with broad healthcare experience, handling matters that include business transactions, fraud investigations, technical regulatory nuances, and other transactional matters. Our team includes corporate attorneys with substantial experience representing healthcare clients and a bond attorney who does quite a bit of work for hospitals in the area of project finance and other transactional settings.

Venable regularly counsels national, regional and local healthcare systems in restructuring, merger, acquisition and affiliation transactions including such legal functions as corporate structure and negotiations, risk and insurance analysis and counsel, regulatory approvals, tax and benefits transitions, executive and workforce employment, risk assessment, succession, transition and compliance. For example, Venable’s corporate and healthcare transactional groups recently represented a regional hospital in its negotiation and execution of a definitive agreement to sell substantially all of its assets to a large nonprofit healthcare organization.

Venable also represented a $5 billion Maryland academic health system in the acquisition of multiple community hospitals. Further, Venable's lawyers designed and implemented a system affiliation and merger growth plan with a large healthcare delivery system in the Midwest that includes four of the Thomson Top 100 Hospitals (from two hospitals to eight – 9,500 employees, $1 billion annual revenue).

Venable's transactional experience also encompasses experience with academic medical institutions. Venable lawyers represented a regional non-profit 130-bed Maryland hospital in its negotiation and execution of an affiliation agreement with a university medical system in Maryland with annual revenues in excess of $2.5 billion as well as a non-profit health system and a large state university system in a merger that yielded a single healthcare entity with 1,342 beds, three hospitals, a drug and alcohol treatment facility, a managed care organization, 77 outpatient clinics and more than 1,000 physicians in Pennsylvania.

We also have experience in designing and implementing legal structures for academic teaching hospital systems in areas of global affiliations, development of new institutes and research centers, and research and transactional alliances with multiple organizations.

White Collar/Internal Investigations

Venable's White Collar Group attorneys are experienced in defending clients in governmental and regulatory agency investigations and enforcement actions; conducting internal investigations; and advising boards of directors, audit and special committees, and individual directors, officers and other corporate executives and individuals in connection with allegations of potential wrongdoing. Venable was recognized by U.S. News and World Reports as the 2013 "Law Firm of the Year in Criminal Defense: White-Collar Litigation."

Our practice group includes former members of the Securities and Exchange Commission’s Enforcement Division (SEC), former United States Department of Justice (DOJ) attorneys, and former Assistant United States Attorneys – all of whom have significant experience in defending governmental investigations and conducting internal investigations. We are retained for matters involving allegations of healthcare fraud, tax fraud, government contracting fraud, whistleblower actions, insider trading, executive improprieties, money laundering, commercial bribery, securities fraud, violations of federal environmental laws, and other matters. We gather the facts and analyze them with the perspective that comes from having years of DOJ and SEC experience.

We understand the stress and disruption that an internal investigation can cause for employees and management. Accordingly, we strive to conduct investigations in a timely manner that respects the organization's business needs and with as little impact on the organization's day-to-day operations, as possible. We know the importance of conducting investigations that are focused and thorough, yet discreet, and that enable our clients to understand the facts readily and to formulate effective responses.