Healthcare

The healthcare industry faces an array of complex regulatory and business challenges which demand legal support across a range of disciplines. We respond to these challenges with a comprehensive scope of services.

Regulatory and Compliance Matters

AGG is recognized nationally for our regulatory and compliance expertise. Our attorneys counsel clients in structuring significant business transactions to comply with complex state and federal laws and regulations affecting the healthcare industry. We have extensive practical experience in developing and implementing individually-tailored compliance programs for the spectrum of clients represented. AGG provides related training as well as monitors and audits the programs to ensure their efficacy in regulating the healthcare payment and delivery systems. We also have substantial experience dealing with complex self-disclosure issues, audits and investigations. We often assist clients in the negotiation, implementation and compliance with Corporate Integrity Agreements.

Clients rely on our advice to meet important federal and state healthcare regulatory requirements, including:

Federal:

  • Anti-kickback Statute, Stark Statute and False Claims Act
  • HIPAA Privacy, Security and EDI Rules
  • EMTALA
  • Change in Ownership (CHOW)
  • Medicare/Medicaid certification and reimbursement
  • FDA, including 510(k) and pre-market approval clearance process, marketing and promotion rules, oversight of human cellular and tissue-based products
  • Clinical research, including Institutional Review Board requirements, and provider/sponsor arrangements
  • Medicaid Rebate and 340B Laws
  • Antitrust compliance

State

  • Certificate of Need
  • Licensure
  • Hospital Authority Law
  • Open Records/Meetings Act
  • Hospital Acquisition Act

Operational Advice

Our attorneys routinely advise healthcare providers on legal issues that arise in the day-to-day operations of their businesses, including:

  • Health Information Technology, Electronic Health Record and EMR issues
  • Joint Commission surveys and investigations
  • Licensure surveys and certifications
  • Contracting
  • Recruitment
  • Risk Management and Peer Review
  • Patient Rights, including consent and end-of-life issues
  • Admission and involuntary transfer/discharge
  • Scope of practice
  • Medical Staff and Hospital Bylaws drafting and disputes
  • Self-Insurance and Captive Insurance Trusts
  • Joint Ventures and Collaborative Arrangements

Reimbursement Issues Including Appeals

AGG’s Medicare/Medicaid Reimbursement Practice Team specializes in Medicare and Medicaid audits and appeals to help providers and suppliers prepare for and manage the new Recovery Audit Contractor (RAC) Program, the Medicaid Integrity Program (MIP) and other post-payment review initiatives. We assist clients with their reimbursement issues involving various public and private payors, including:

  • Medicare Part A (facility)
  • Medicare Part B (professional, outpatient and Part B-covered drugs)
  • Medicare Part D (drug benefit)
  • Medicaid Reimbursement and Medicaid Managed Care

The range of services related to the above are as follows:

  • Challenging rules and interpretations relating to such matters
  • Advocating and negotiating changes to local coverage determinations
  • Appealing overpayments, denials and recoupments
  • Providing guidance concerning new reimbursement rules, regulations and agency and court decisions that may affect a client’s business success
  • Providing representation in cost-report appeals before the Provider Reimbursement Review Board
  • Negotiating payor contracting
  • Litigating reimbursement matters, representing clients in significant cases in state and federal agencies and courts across the nation
  • Assisting with pharmaceutical pricing issues

Corporate and Transactional Practice

AGG’s Healthcare Team helps clients negotiate, structure, document, conduct due diligence, achieve regulatory compliance including healthcare transactions, both small and large, simple and complex. A sample of our expertise is as follows:

  • Mergers and Acquisitions, including purchase and sale transactions for facilities and operations
  • Joint Ventures and Strategic Alliances
  • Complex Commercial Agreements
  • Affiliations, Research Collaborations and Licensing Agreements
  • Equity and Debt Financings
  • Restructurings and Workouts
  • Facility Structure and Financing
  • Corporate Formation and Choice of Business Entity
  • Change of Ownership (CHOW) Advice
  • Corporate Governance Compliance and Best Practices
  • REITs

Our attorneys add value for our clients through healthcare-experienced and focused negotiations, due diligence and attention to healthcare statutes and regulations. We work to tailor documents to the specific transaction, including reviewing representations and warranties, analyzing key sections and determining the appropriate structure for the transaction while taking into account the regulatory and reimbursement implications.

Litigation

Our attorneys have successfully litigated several significant cases in state and federal trial and appellate courts across the country covering virtually every aspect of healthcare law, including:

  • Internal investigations and the defense of allegations of fraud involving government programs
  • Criminal investigations of patient abuse and related civil actions
  • Actions brought under the False Claims Act including qui tam and whistleblower lawsuits
  • Reimbursement Appeals before the Provider Reimbursement Review Board and in the courts

In recent years, clients have increasingly looked to us for assistance with quality-of-care issues and related litigation. This expertise is rooted in our extensive involvement with reimbursement issues

  • Provider licensing and certification investigations and litigation
  • Certificate of Need disputes
  • Medical Staff Disciplinary Actions, Due Process and Fair Hearings
  • OIG exclusion proceedings
  • Legislation and Health Policy

Our attorneys routinely draft legislation and regulations for submission before various state and federal legislative bodies. We are frequently called upon to comment and provide testimony on proposed legislation and regulations affecting the healthcare industry.

Other Interdisciplinary Areas

In addition, AGG offers its healthcare clients the convenience of a full-service law firm, with attorneys in related interdisciplinary areas with healthcare-specific experience in their area of expertise, including:

  • Labor and Employment
  • Employee organizing
  • Collective bargaining agreements
  • Labor arbitrations
  • Equal opportunity law
  • Employment discrimination
  • ERISA
  • OSHA compliance
  • Tax Matters and Controversies for Nonprofit and For-Profit Entities
  • Tax-exempt, 501(c)(3) and public charity status
  • Unrelated business income tax
  • Private benefit and inurement rules
  • Executive compensation
  • Private foundation rules
  • Fundraising
  • Intermediate sanction matters
  • Audits and administrative appeals before the IRS and state and local taxing authorities
  • ERISA and other aspects of qualified and non-qualified plans, welfare and fringe benefit plans, golden parachute and deferred compensation arrangements, stock options and other equity-based arrangements
  • Executive employment agreements
  • Employee benefits, including stock options, restricted stock and phantom stock arrangements, supplemental executive retirements plans, deferred compensation arrangements, rabbi trusts, and incentive plans.
  • Real Estate
  • Medical Office Buildings
  • Financing and Joint Ventures
  • REITs
  • Purchase and sale transactions
  • Leasing

This healthcare expertise allows our clients to receive industry-specific advice and guidance, yielding positive business outcomes.

Our People

AGG maintains one of the largest healthcare-dedicated practices in the country. A recent issue of the Health Lawyer News lists AGG’s Healthcare Practice Group as one of the 50 largest in the United States. In addition to this broad substantive experience, attorneys in AGG’s Healthcare Group have diverse backgrounds and experience in the healthcare industry, including those who have:

  • Served with the Government, representing agencies such as the Centers for Medicare and Medicaid Services (CMS), the Department of Health and Human Services (DHHS), the Office of the Attorney General, and the Department of Justice (DOJ)
  • Served as Assistant United States Attorney, Assistant District Attorney and Deputy Attorney General
  • Been advisors on national advisory committees and task forces for CMS and trade associations
  • In-house experience in a variety of settings
  • Served as officers of national and state health law and legal organizations
  • Advanced educational degrees in healthcare
  • Front-line work experience for institutional and healthcare providers, institutions, nonprofit organizations and for-profit companies, including oversight responsibility for clinical trials
  • Held faculty positions at universities
  • National recognition, within such publications as the Chambers USA Survey of America’s Leading Lawyers for Business, Super Lawyers, Georgia Trend’s Legal Elite