Practice Groups →Health Care Law
Regulatory & Compliance
Health care providers face a constant stream of regulatory requirements at both the state and federal level.
Medicaid and Medicare billing rules, HIPAA obligations, New York State Department of Health (DOH) and Office of Medicaid Inspector General (OMIG) requirements, staffing and supervision standards, and program integrity initiatives all demand attention. The risk of noncompliance is real: audits, civil penalties, repayment demands, and in serious cases, Medicaid/Medicare program exclusion.
We work with providers to build compliance programs that are practical and sustainable, advise on specific regulatory questions as they come up, and help organizations stay current as requirements change. Whether you need to create and establish a compliance program, your existing compliance program evaluated, a policy and procedure update, or day-to-day regulatory guidance, we can help you.
We also regularly advise physicians, entrepreneurs, and health care operators at the earliest stages of forming new health care businesses and professional practices. Early regulatory analysis helps clients avoid structural and operational decisions that can create compliance exposure, billing risk, or audit vulnerability down the line.
Compliance program development, review, and training
Our regulatory and compliance services include:
We work with clients to develop a compliance plan or review, revise and update their existing compliance plan in accordance with the requirements of OMIG set forth in 18 NYCRR Part 521-1 and the self-disclosure regulations set forth in 18 NYCRR Part 521-3, as well as Medicare requirements and Office of the Inspector General (“OIG”) guidance. This package includes a compliance plan, standards of conduct and Deficit Reduction Act policy, as well as corporate documentation necessary to formally adopt the revised plan.
We develop and provide compliance training to the governing body and senior staff, either in person or via web conference. This package includes a copy of compliance training materials and a post-evaluation effectiveness tool.
This package is available in tandem with the Governing Body/Senior Staff training or as a standalone package, and includes the development of either (1) written training materials or (2) a pre-recorded web-presentation appropriate for training front-line staff.
Providers subject to the OMIG Compliance Program requirements are required to conduct an annual effectiveness review of their compliance program. We provide an independent compliance program effectiveness review which includes: (a) review of the existing compliance materials; (b) an assessment of the adequacy of documentation of the implementation; and (c) the effectiveness of the plan as measured by key metrics. A final report is prepared summarizing the results of the review, identifying strengths of the compliance program and any gaps in the compliance program’s structure or functioning. The final report includes recommendations for addressing identified gaps and strengthening the program. Providers may elect to also have the results of the Compliance Program Effectiveness Review shared with the governing body and senior management at an in-person or web-based presentation.
We work with clients to assist them in the development of a compliance work plan, training plan, and audit plan as required by 18 NYCRR Part 521-1. This package includes a work plan template and assistance in populating the work plan in a manner that best meets the needs of the organization.
Regulatory guidance and risk review
We advise physicians and business partners on forming professional practices and management services organizations (MSOs), including structuring arrangements to comply with New York’s corporate practice of medicine rules, fee-splitting restrictions, and related regulatory requirements.
We advise on billing rules, documentation standards, and coverage requirements, with a focus on identifying billing practices that present elevated risk for recoupment or enforcement action.
We help providers comply with HIPAA and state privacy laws, respond to potential breaches, and develop policies and training to reduce ongoing privacy risk.
We provide practical guidance on new and evolving statutes, regulations, and agency directives, helping providers assess operational impact and adjust processes accordingly.
We assist providers in evaluating potential overpayment or compliance issues, preparing and submitting self-disclosures, and managing the process to reduce downstream risk.
We conduct mock audits focused on billing, documentation, supervision, and operational issues that historically present higher risk for recoupment. These reviews support ongoing compliance efforts and help organizations address vulnerabilities before they are identified by regulators.
We work alongside billing consultants, compliance professionals, and financial advisors to provide integrated legal analysis and risk assessment.
Predictable options begin with a conversation.
Tell us what is in front of you. We will help you understand your options and what each one involves.