The U.S. health care system is changing and so are the legal and public policy needs of health care companies. Recent legislative action, including both the Patient Protection and Affordable Care Act and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), has created a host of new regulations that must be considered. In addition, the expected new payment models and increased numbers of insured patients present both challenges and opportunities for companies that do business with payors and providers.
Bringing together attorneys and public policy advisors from the regulatory, corporate, public policy, government contracts, litigation, employee benefits and tax practices, MLA’s health care team uses their diverse experience to deliver comprehensive legal and public policy services at the intersection of business and government. In particular, MLA’s health care professionals concentrate on helping clients develop proactive compliance strategies, avoid violations of federal and state laws and regulations and defend their interests in audits and investigations. Our extensive and diverse experience enables us to serve clients to ensure they maintain compliance while capitalizing on opportunities in new legislation. Many of the health care team attorneys are recognized by Chambers for being among the leading health care industry legal practitioners.
HEALTH CARE COMPLIANCE, INVESTIGATIONS AND AUDITS
Today’s health care industry faces a multitude of regulations resulting in complexities and challenges to organizations, providers and patients alike. The complexity of such regulations brings substantial risk to an entity’s financial stability and professional reputation.
MLA offers clear counseling on and adept understanding of the health care industry’s regulatory environment, thereby assisting clients with developing and implementing plans designed to ensure compliance. Providing regular counsel on a wide range of federal and state statutes and regulations that affect players in the health care industry, our attorneys offer advice regarding compliance with:
- Reimbursement under federal, state and private health care programs
- Federal and state fraud and abuse laws
- Federal and state self-referral and fee splitting laws and regulations
- Licensing, accreditation and reporting requirements
- Human subject research regulatory compliance
MLA also has extensive experience on privacy-related matters, including regularly advising clients on compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the HITECH Act.
MLA represents health care providers in all aspects of health care fraud and abuse matters, including both criminal and civil cases. Specifically, MLA’s team has extensive experience in defending our clients, including entities and corporate officers and directors, in investigations, ranging from small state investigations to large federal Department of Justice (DOJ) investigations of Fortune 500 companies.
In these roles, we have negotiated settlement agreements, Corporate Integrity Agreements, Certification of Compliance Agreements and Assurances of Voluntary Compliance. We work successfully with the DOJ, Office of Inspector General (OIG), Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS), as well as State Medicaid Fraud Control Units and various State Attorneys General and Inspectors General.
Additionally our team has experience representing individuals and companies before the U.S. Congress, including the House Committee on Energy and Commerce.
Reimbursement and Audit Defense
MLA offers broad-based expertise on Medicare, Medicaid and commercial payor reimbursement issues. Our attorneys possess substantial experience in defending providers in government and private audits and investigations regarding reimbursement, coding and documentation. Our clients look to us for services related to:
- Government payor billing and documentation issues
- Responses to government and private audits and investigations
- Medicare cost report and fee-for-service appeals
- Responses to government reviews and medical documentation requests
- Medicare and Medicaid provider enrollment and conditions of participation
- Medicaid and state-funded medical program issues, audits and appeals
- Self-audits, refunds and voluntary disclosures
- Contract disputes with commercial payors
- Assistance with pharmaceutical pricing issues
- Clinical trial and research billing and reporting
- Guidance concerning reimbursement rules, regulations and agency and court decisions that may affect a client’s business, and challenging such rules and interpretations
Increasing budgetary pressures on state and federal governments, make health care fraud and abuse of increasing concern to lawmakers and other government officials. In particular, the Obama administration has made clear it intends to hold not only companies, but also their officers and directors, accountable for fraudulent activities.
By addressing its governance practices proactively, a board can stay at the fore of best practices, allowing it to focus on the substantive matters that impact operations and drive shareholder value. To ensure an unbiased and thorough assessment, many boards have turned to independent advisors to conduct reviews of their practices. MLA offers clients a cross-practice team of corporate, health care regulatory and public policy professionals designed to help boards understand how increased scrutiny and regulatory changes will impact their industry and identify a proactive path to ensure they are positioned strategically in light of the current regulatory environment.
MLA’s team draws upon the existing work of our health care regulatory attorneys and the firm’s Corporate Governance Center, a targeted resource focused on helping boards navigate the changing terrain of corporate governance. Representing numerous boards, including the boards of Fortune 100 companies, the Governance Center offers clients assistance in:
- Governance Reviews
- Compliance Programs
- Crisis Management
- Maximizing Board Dynamics
- Policy Development and Advocacy
MLA’s health care policy team focuses on helping clients anticipate the impact of legislation, think strategically about potential business opportunities and shape future legislative and regulatory action. Bringing together our public policy and legislative experience, we support our clients by developing comprehensive, step-by-step work plans, authoring and advising on position papers and agency comments, representing clients at meetings on Capitol Hill as well as with federal and state agencies, and connecting clients with policymakers and thought leaders across the country. Our health care policy team has focused recently on pressing issues such as:
- Medicaid and Medicare payment reform, including global payments, accountable care organizations (ACOs), medication therapy management, medical homes, obesity treatment models and the budgetary pressures on states created by rising health care costs
- Health insurance exchanges, including shifts in payor mix and the likely impact on reimbursement rates, eligibility, enrollment and essential health benefits
- Health-related funding opportunities, including the new Prevention and Public Health Fund, the Center for Medicare and Medicaid Innovation and grant opportunities at the National Institutes of Health, Health Resources and Services Administration and the Department of Agriculture
Today’s environment makes the quality of congressional and agency relationships even more critical. Moreover, the current political environment requires any legislative effort -particularly related to health care - be carefully thought through from a bipartisan perspective, organized to navigate the complex and shifting political currents in Washington and complemented by a broad-base of support from multiple interest groups throughout the country and across the political spectrum.
Our health care team has extensive experience advocating before the U.S. Congress and state governments. Our bipartisan team includes former governors, members of Congress and diplomats, as well as individuals who have served as staff to U.S. presidents, governors, members of Congress and mayors. Attorneys who are part of our health care and government contracts teams work daily with the complexities of Medicare, Medicaid, TriCare and other reimbursement issues and provide substantive support to many of our policy and government affairs initiatives. This extensive experience at the highest levels of government allows us to successfully represent our client’s interests on a diverse range of issues and changing circumstances.
Uniquely, MLA’s bipartisan political experience extends beyond Washington into the states. Our colleagues hold finance committee positions at both the Republican Governors Association and Democratic Governors Association, giving us access and insight to state policy and our nation’s governors. These diverse and wide ranging experiences and relationships ensure our team has experienced the gambit of political scenarios and divisions of power in Washington, and is therefore well-suited to represent your issues in this unique political time.
Health Insurance Exchanges
A key component of the Patient Protection and Affordable Care Act, Health Insurance Exchanges will impact almost every sector of the health care industry. MLA boasts a first-in-the-nation Health Insurance Exchange Team, a unique cross-practice initiative designed to help clients prepare strategically for the impact of health insurance exchanges on their business; specifically how Exchanges will affect providers, suppliers, insurers and employers.
In particular, MLA’s team is focused on the political and policy decisions driving implementation on the state level, including real-time tracking of state developments. In addition, the Health Insurance Exchange Team has completed research surrounding:
Key state decisions necessary to implement an Exchange
- Eligibility determination processes
- Subsidy flow
- Functions of an Exchange, including a potential aggregator function
- Essential health benefits
More information on MLA’s Health Insurance Exchange Team is available here.
MLA is home to the oldest, largest and most successful government contracts practice in the country. As such, our attorneys have significant experience with all federally-funded health care programs. In particular, we assist clients in developing government bids and proposals, forming joint ventures and teaming arrangements and drafting prime contracts and subcontracts. We are experienced in government contract performance matters, including interpreting contract requirements, protecting technical data and responding to audits.
In addition, our Government Contracts practice maintains long-standing and effective relationships with government payors, including the Department of Defense, Tricare and the Federal Employees Health Benefits plan, as well as the Veterans Administration. Specifically, MLA has considerable experience assisting managed care organizations, carriers and intermediaries, pharmaceutical manufacturers and other health care companies enter into contracts with federally funded health care programs.
Health law and life sciences continue to overlap, particularly in the area of clinical research. MLA’s cross-practice team of attorneys and public policy advisors work together to identify advances in science and support clients across the health care sector in their clinical research efforts. In particular, our attorneys advise clients on:
- Clinical research compliance protocols, including fraud and abuse compliance
- Structuring of arrangements between sponsors, grantees, subcontractors, sites, investigators and collaborators
- Arrangements established through clinical trial agreements, consortium agreements, prime and subrecipient agreements, clinical research organization (CRO) agreements and principal investigator agreements
Our attorneys also counsel Institutional Review Boards (IRB) and serve as IRB members.
Finally, MLA has one of the broadest, most experienced practices in the area of public health procurement, federal health care programs, biodefense and the marketing and sales practices of pharmaceutical companies, biotechs and medical suppliers. Our attorneys and professionals work consistently with multiple government offices and agencies, particularly the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) and its relevant agencies, to build strong, strategic relationships that position our clients to achieve their legislative and funding goals. In addition, we assist clients in developing government bids and proposals, forming joint ventures and teaming arrangements and drafting prime contracts and subcontracts. We are experienced in government contract performance matters, including interpreting contract requirements, protecting technical data and responding to audits.
HEALTH CARE TRANSACTIONAL SERVICES
The economic expansion and growth of regulatory complexities that the health care industry has experience in recent years has resulted in significant increase in corporate restructuring for both for-profit and not-for-profit health care entities. MLA offers sophisticated guidance to clients seeking advice on a wide variety of transactional matters, ranging from the financing and structuring of deals (both public and private), including related tax consideration and planning, to general corporate counseling and governance.
Our lawyers handle all aspects of consolidations, divestitures, spin-offs, acquisitions, strategic affiliations and business formations customized to meet the varying needs and objectives of our clients. We provide clients with comprehensive service in connection with mergers and acquisitions, including advising on transaction structuring, risk assessment, drafting and negotiating transaction documents and all tasks associated with closing transactions and integration. As joint ventures and strategic alliances have continue to grow as favorable alternatives to traditional mergers and acquisitions, so too has our ability to respond to client needs by offering experience counsel in complex areas including tax, regulatory, intellectual property and employee benefits, among others. In addition, we provide full service to our health care clients in connection with physician contracting and physician recruitment, as all proposed relationships and payments must be examined carefully in light of federal and state fraud and abuse and physician self-referral laws to ensure compliance.
MLA’s Public Finance practice serves local, state, regional and national clients in all areas of public finance. Members of the team have participated in public finance transactions in virtually every state in the country in transactions that total more than $84 billion in aggregate principal amount. We have worked with hospitals and hospital authorities on over $3 billion of public finance transactions in the last decade.
Lawyers in MLA’s Public Finance practice serve as Bond Counsel, Special Tax Counsel and Disclosure Counsel and have participated in a wide variety of governmental financings done on a tax-exempt and taxable basis. Additionally, lawyer in MLA’s Public Finance practice also frequently serve as tax controversy counsel in audits of tax-exempt obligations by the Internal Revenue Service.
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- Public Policy and Regulatory Affairs
- Real Estate
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