Health Care Governance, Regulatory Compliance and Reform Issues
The Pannone Lopes Devereaux & O'Gara LLC health care team consists of experienced health care attorneys, litigators and employment and corporate lawyers who combine their technical expertise and litigation skills to represent health care organizations and hospitals, physicians, physician group practices and individual practitioners to navigate the transformative changes that have occurred in the health care industry.
Health Care Lawyers
The effects of the Patient Protection and Affordable Care Act (ACA) vary significantly depending on the type and structure of the provider organization and many other factors. Reimbursement, compliance, HIPAA, fraud and abuse laws, ICD-10 codes, data collection and use, and the evolution of Accountable Care Organizations (ACO) are among the numerous areas undergoing significant change. Our health care attorneys work with clients to focus on the aspects of reform that applies to their organization. Among the most far-reaching aspects of health care reform is the "meaningful use" requirement for electronic health records. PLDO assists clients in understanding the mandates and in securing incentive payments available to those providers in compliance with the law.
Corporate Governance and Contracting in Health Care
The PLDO health care and business law teams assist health care entities in all aspects of corporate formation, expansion, joint ventures, mergers and acquisitions. We routinely assist clients in structuring an organization or modifying its corporate governance. PLDO routinely represents both for-profit and nonprofit organizations.
PLDO also provides its clients with an understanding of corporate governance, including fiduciary responsibilities, committee membership responsibilities, and establishing policies and procedures and corporate compliance programs. Our attorneys serve as board members for numerous charitable organizations, meaning that we not only advise clients on professional and ethical standards for corporate board members, but we put those standards into practice ourselves every day.
Contracting in the health care arena can expose organizations to fraud and abuse liability based upon relationships that would be considered a best practice in most industry groups. This is a particular concern for institutions that import leadership from other industries. Crafting an incentive program to encourage referrals might lead to enhanced profits in other industries, but in the health care industry, it would likely constitute a violation of the Anti-Kickback Statute. PLDO's health care team works with our clients to maximize the value of their contractual relationships while steering clear of the many pitfalls inherent in this highly regulated industry.
Regulatory Compliance and Reimbursement Health Care Lawyers
The PLDO health care team possesses the requisite experience to deal with myriad legal and business issues relating to implementing effective compliance programs or preventing an unwanted enforcement action. PLDO lawyers guide clients through the maze of regulation in an effort to avoid inadvertent mistakes that sometimes result from an organization's lack of regulatory awareness or not having designed and implemented an effective compliance program.
We will conduct risk assessments to identify corrective action and provide the guidance needed to establish compliance training programs at all levels of the organization. Effective compliance programs must be proactive if they are to serve as a mitigating factor in an enforcement action. A "paper program" will not deter violations and has little to no mitigating effect in a potential enforcement action.
The cost of developing and implementing an effective compliance program is far less than the potential treble damages and government attorneys' fees that may result from even a minor False Claims Act violation. Developing and implementing an effective compliance program will also enhance the organization's ability to maximize reimbursements. Government agencies are vigilant in preventing overpayments; however, they do not assist providers or suppliers in capturing all available reimbursement. PLDO health care attorneys work with the client to maintain a current understanding of the constantly changing legislation and regulations while maximizing the reimbursement opportunities that are so essential to the client's financial viability.
Litigation and Other Contested Matters in Health Care
The complexities faced by health care organizations often lead to disputes with vendors, partners, medical staff and others. PLDO's familiarity with the health care industry allows us to often resolve disputes without damaging the underlying relationships that are critical to the clients' ongoing operations. The PLDO litigation team’s representations cover a broad spectrum of contested matters, ranging from civil litigation to agency and administrative determinations.
PLDO also represents health care clients before governmental agencies, including Provider Reimbursement Review Board appeals and appearances before administrative law judges. In addition, our experienced attorneys represent clients on either side of applications for Certificates/Determinations of Need and HIPAA violation defense that can jeopardize JCAHO (Joint Commission on the Accreditation of Healthcare Organizations) accreditation and insurance malpractice premiums. PLDO recently represented a hospital in successfully opposing an application for a major service expansion submitted to a state regulatory agency by one of New England's largest health care systems.
Lawyers Handling Issues Involving Health Care Fraud and Abuse
The health care industry is a minefield of rules and regulations, all of which present potential liability to the provider, including:
- The Anti-Kickback Statute
- The Stark Law
- The False Claims Act
- The qui tam whistleblower statute
- Health Insurance Portability and Accountability Act (HIPAA) privacy and security provisions
- The Fraud Enforcement and Recovery Act
- The Patient Protection and Affordable Care Act
- Corresponding state laws
The PLDO health care team is experienced in dealing with the Department of Justice, the Health and Human Services Office of the Inspector General (OIG) and Office of Civil Rights, Medicare fiscal intermediaries, state prosecutors and Medicaid agencies in defending against enforcement actions, health care fraud criminal charges, investigations, agency audits and repayment demands.
Our health care attorneys are highly skilled in developing effective strategies to address criminal charges and civil allegations. They also have the experience to identify and effectively employ Safe Harbor regulations, obtain OIG advisory opinions, or negotiate a Corporate Integrity Agreement or Deferred Prosecution Agreement that is in the client's best interest.
PLDO attorneys successfully negotiated one of the nation's few Deferred Prosecution Agreements implemented in a health care setting. Our attorneys are experienced in developing defenses to enforcement actions that may result from:
- Cost reporting, billing and coding issues
- Upcoding and unbundling issues
- Self-referral issues; recruitment
- Referral arrangements
- Joint ventures involving leasing of equipment or laboratory facilities
- Physician practice acquisitions
- Marketing; medical device and durable medical equipment (DME) issues
- Pharmacy reimbursement issues related to generics and substitution
- HIPAA violations
- Alleged violations of the Honest Services Doctrine
Experienced Lawyers Handling Labor and Employment Issues in Health Care
Health care providers are among the most labor-intensive of employers, and they face a unique combination of labor and employment concerns. Providers are often unionized and governed by Employee Retirement Income Security Act (ERISA) benefits plans, which in turn are often self-insured. Health care-specific concerns such as HIPAA, state privacy laws and patient-safety laws add another level of complexity not found among other employers.
The Patient Protection and Affordable Care Act(ACA) contains numerous provisions related to employee benefits plans. PLDO assists employers in analyzing the effects of retaining a grandfathered plan, understanding the requirements of non-grandfathered plans, and structuring new plans that comply with both evolving law and existing bargaining agreements.
PLDO's health care team is highly experienced in advising and representing the full spectrum of health care employers. PLDO frequently represents employers in labor mediations, as well as before the Occupational Safety and Health Administration (OSHA), the Equal Employment Opportunity Commission (EEOC), the Massachusetts Commission Against Discrimination, the Rhode Island Commission for Human Rights, and federal and state courts.
Bankruptcy, Receivership and Creditors' Rights Health Care Lawyers
PLDO assists challenged health care institutions in capitalizing upon the most advantageous strategies available under bankruptcy and receivership law. Medicare and Medicaid regulations make health care provider bankruptcy and receivership unique among industries and dramatically impact the normal rules regarding debtors' and creditors' rights; even the choice of which court to file in holds unique considerations for a health care institution facing bankruptcy. PLDO works with both debtors and creditors to maximize their rights in a health care bankruptcy, receivership or restructuring.
To learn more about how PLDO can help you address your health care law issues, contact our firm, headquartered in Johnston, Rhode Island.
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