HEALTH CARE
The PLDW Health Care Team consists of experienced litigators, health care, employment and corporate practitioners who combine their expertise to represent and assist their clients in the health care industry.
FRAUD & ABUSE
The health care industry is a mine field of rules and regulations all of which present potential liability to the provider, including, the Anti-Kickback Statute; Stark Laws; the False Claims Act; the Qui Tam Whistleblower statute; HIPAA Privacy and Security provisions; the Fraud Enforcement and Recovery Act; the Patient Protection and Affordable Care Act together with corresponding state laws. The PLDW Health Care Team is experienced in dealing with the Department of Justice, the HHS Office of Inspector General and Office of Civil Rights, Medicare fiscal intermediaries, state prosecutors and Medicaid agencies in defending against enforcement actions, criminal charges, investigations, agency audits and repayment demands.
Our attorneys are highly skilled in developing effective strategies in addressing criminal charges and civil allegations and have the experience necessary 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.
PLDW 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 DME issues;
• pharmacy reimbursement issues related to generics and substitution;
• HIPAA violations;
• alleged violations of the Honest Services Doctrine.
REGULATORY COMPLIANCE & REIMBURSEMENT
The PLDW Health Care Team possess the requisite experience to deal with a myriad of legal and business issues relating to implementing effective compliance programs or preventing an unwanted enforcement action. PLDW attorneys guide their clients through the maze of regulation in an effort to avoid inadvertent mistakes which are sometimes the result of the 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. PLDW 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.
LABOR & EMPLOYMENT
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 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 recent Patient Protection and Affordable Care Act contain numerous provisions related to employee benefits plans. PLDW assists employers in analyzing the effects of retaining a grandfathered plan, understanding the requirements of non-grandfathered plans, and structuring new plans which comply with both evolving law and existing bargaining agreements.
PLDW's Health Care Team is highly experienced in advising and representing the full spectrum of health care employers. PLDW frequently represents employers in labor mediations, as well as before OSHA, the EEOC, the Massachusetts Commission Against Discrimination, and the Rhode Island Commission for Human Rights, and federal and state courts.
CORPORATE, GOVERNANCE, & CONTRACTING
The PLDW Business Law Team assists health care entities in all aspects of corporate formation, expansion, joint ventures, mergers and acquisitions. We routinely assist clients in structuring their organization or modifying its corporate governance. PLDW routinely represents both for-profit and non-profit organizations. The firm has created alliances with consultants to develop a center for excellence for nonprofit organizations to assist them in finding and utilizing state of the art methods to operating the nonprofit organization more effectively.
PLDW also provides its clients with an understanding of corporate governance, including fiduciary responsibilities, committee membership responsibilities, establishing policies and procedures and corporate compliance programs. Our attorneys serve as boardmembers of numerous charitable organizations, meaning that we not only advise clients on the professional and ethical standards for corporate boardmembers, we put those standards into practice ourselves every day.
Contracting in the health care arena can expose organizations to fraud & 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 encouraging referrals might lead to enhanced profits in other industries; whereas, in the health care industry it would likely constitute a violation of the Anti-Kickback Statute. PLDW'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.
HEALTH CARE REFORM
Among the most far-reaching aspect of health care reform is the Meaningful Use requirement for electronic health records. PLDW assists clients in securing incentive payments available to providers who make meaningful use of certified health record technology.
The effects of recent health care reform legislation vary significantly depending on the nature of the organization. Reimbursement, Compliance, HIPAA, and Fraud & Abuse laws are among the numerous areas under-going significant change, and PLDW works with clients to focus upon the aspects of reform that apply to their organization.
LITIGATION AND OTHER CONTESTED MATTERS
The PLDW Litigation Team represents clients in a broad spectrum of contested matters which range from civil litigation to agency and administrative determinations. The complexities faced by health care organizations often lead to disputes with venders, partners, medical staff, and others. PLDW's familiarity with the health care industry allows us to often resolve disputes without damaging the underlying relationships which are critical to the clients' ongoing operations.
PLDW also represents health care clients before governmental agencies, including Provider Reimbursement Review Board appeals and appearances before an Administrative Law Judge. PLDW also represents clients on either side of applications for Certificates/Determinations of Need. PLDW 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.
BANKRUPTCY, RECEIVERSHIP & CREDITORS' RIGHTS
PLDW assists challenged health care institutions in capitalizing upon the most-advantageous strategies available under bankruptcy or receivership law. Medicare and Medicaid regulations make health provider bankruptcy or receivership unique from all other 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. PLDW works with both debtors and creditors to maximize their rights in a health care bankruptcy, receivership, or restructuring.
