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State & Federal Regulatory Compliance
In addition to the ordinary business concerns that apply to all business and transactions, healthcare businesses and transactions are subject to additional scrutiny for their compliance with the tangled web of state and federal restrictions on self-referral and other prohibited economic relationships. For example, the federal Stark regulations and Anti-Kickback Statute are implicated by any arrangement or relationship that involves any federal health care program (such as Medicare or Medicaid). In addition, New Jersey has additional, distinct, and broader statutory rules governing health care providers’ business relationships. The repercussions for the violation of these statutes can include criminal and civil penalties, as well as exclusion from participation in federal health care programs. For these reasons, it is imperative that practitioners in the healthcare arena have a basic grasp of the Statute, its safe harbors, and its practical application. We regularly advise healthcare providers on the legal permissibility of relationships with other providers, managers, marketers, and other business entities. Does your office satisfy the ever-evolving and prolifically monitored stringent Federal requirements for HIPAA and OSHA? Is Protected Health Information (PHI) safeguarded and cybersecure? Are your employees working in the safest of environments? Gallagher Campanella LLC provides comprehensive HIPAA and OSHA compliance counseling, services, manuals, and educational/risk assessment services for small and complex medical practices. Gallagher Campanella LLC counsels providers to determine and ensure HIPAA compliance or when responding to allegations of noncompliance by state and federal regulators. We have assisted numerous providers, including physician organizations, skilled nursing and other long-term care facilities, educational institutions, software providers, and medical billing companies, with developing compliant notices and practices in their practices. Gallagher Campanella LLC represents healthcare providers during investigations, audits, and administrative actions by the federal Drug Enforcement Administration (DEA), the State Board of Medical Examiners in New Jersey, and the Office of Professional Medical Conduct in New York. We also assist providers in investigating controlled substance irregularities and resolving DEA and state CDS certification issues. With the advent of data mining, discrepancies in controlled substance prescribing or dispensing patterns increasingly trigger DEA and CDS scrutiny. Healthcare providers who prescribe and dispense Controlled Substances (Schedules II through V) are at risk of being audited for their compliance with DEA and CDS requirements. Gallagher Campanella LLC provides its clients with cutting edge counseling in all areas of cybersecurity to safeguard Protected Health Information (PHI) and patients’ financial information. We also provide counseling services to individual practitioners and practices (large and small) on how best to set up and optimize their systems to ensure unmatched levels of privacy and security on their networks, EMRs and “smart” products. In the current regulatory environment, healthcare providers are under greater scrutiny than ever before. While the Centers for Medicare and Medicaid Services (CMS) always had the right to review and deny services deemed to be inappropriately billed, health care reform and other recent initiatives have added even more programs and contractors that will be looking at providers' claims. We know that receiving notice of an alleged "overpayment" from one of CMS' contractors or a private payor can be a stressful experience for healthcare providers. While healthcare providers do not necessarily need an attorney to appeal claims, the appeals process can be confusing and burdensome to those who are unfamiliar with it. There are legal and procedural arguments that can be advanced most effectively by attorneys with experience in this area. Gallagher Campanella LLC has successfully defended thousands of Medicare, Medicaid, and third party payor audits on behalf of healthcare entities, providers and suppliers nationwide. We assist providers in various ways, from "full service" handling of all levels of the appeals submissions, to assisting with the drafting of templates, position papers or briefs for healthcare providers who want to handle the appeals on their own.