Healthcare Laws

SJKP LLP helps clients understand and comply with key federal laws that form the backbone of healthcare regulation. We provide strategic advice on matters involving billing practices, data privacy, electronic health records (EHR), marketing compliance, Medicare and Medicaid reimbursements, and audits. Our services are designed to help you build a strong compliance framework that mitigates risk and ensures your operations are legally sound.

• - The Affordable Care Act (ACA): This landmark legislation has far-reaching effects on health insurance, delivery models, and provider obligations.

- The Health Insurance Portability and Accountability Act (HIPAA): This law governs the privacy and security of patient health information, requiring strict data protection protocols.

- The Anti-Kickback Statute (AKS): The AKS prohibits offering or accepting anything of value to induce referrals for services covered by federal healthcare programs.

- The Stark Law (Physician Self-Referral Law): This law restricts physician referrals to entities with which they or their immediate family members have a financial relationship.

- The False Claims Act (FCA): The FCA is a powerful tool for the government to combat fraud and abuse, holding healthcare entities accountable for submitting false claims.

Beyond federal statutes, each state imposes its own unique licensing, enforcement, and professional compliance obligations. Navigating this patchwork of state laws can be particularly challenging for entities that operate in multiple jurisdictions or those looking to expand. SJKP LLP ensures healthcare providers, facilities, and professionals meet these local standards while minimizing enforcement risk and reputational harm, providing comprehensive guidance on state-specific requirements.

Our team advises hospitals, private equity investors, physician groups, and health tech firms on a wide range of transactional matters. We provide end-to-end legal guidance, ensuring compliance and strategic alignment from the initial due diligence phase to closing and post-transaction integration. Our work in this area is designed to help you achieve your growth objectives while navigating the intricate regulatory environment.

• - M&A Due Diligence: Thoroughly vetting a target company's compliance, operational, and financial health.

- Antitrust Clearance: Including preparing and filing necessary documents with the FTC and DOJ, such as HSR filings, to secure regulatory approval.

- Certificate of Need (CON) Regulations: Assisting with state-specific applications and approvals required for new construction, expansion, or changes in service.

- Tax-Exempt Entity Structuring: Guiding non-profit healthcare organizations on transactions that maintain their tax-exempt status.

- Joint Venture Agreements: Drafting and negotiating agreements that define the roles, responsibilities, and financial arrangements for new partnerships.

Investors face unique risks when entering the healthcare market. We help mitigate those risks by conducting detailed regulatory diligence, structuring compliant transactions, and ensuring long-term operational success through governance and compliance support. Our team understands the specific concerns of investors, from valuation issues related to regulatory compliance to structuring deals that protect against future liability. We provide comprehensive counsel to help you make informed investment decisions and maximize value.

Our attorneys are skilled at consulting healthcare clients in FCA investigations, qui tam lawsuits, and audits from CMS, OIG, and DOJ. The stakes in these matters are incredibly high, often involving significant monetary penalties and reputational damage. We also assist in internal investigations to identify and resolve issues before enforcement escalates, providing strategic counsel to help you navigate these complex legal challenges and build a strong defense.

SJKP LLP represents both payors and providers in reimbursement disputes, breach of contract cases, and managed care litigation. We advocate before courts, arbitration panels, and administrative agencies across the country, leveraging our deep understanding of the healthcare payment system to achieve favorable outcomes for our clients. Our goal is to resolve disputes efficiently and effectively, whether through negotiation, mediation, or aggressive litigation.

We assist digital health and med-tech clients with product classification, FDA submissions (510(k), De Novo, PMA), labeling compliance, post-market surveillance, and more. Our team helps you develop a comprehensive regulatory strategy from the ground up, ensuring your products are designed and marketed in a way that meets FDA requirements and accelerates time to market. We stay up-to-date on the latest FDA guidance and enforcement trends to provide the most current and effective advice.

Healthcare providers are custodians of some of the most sensitive data in the world. We provide counsel on HIPAA, the 21st Century Cures Act, and cybersecurity best practices, helping you build robust data protection programs. Our attorneys also help clients respond to breaches and implement incident response protocols, minimizing damage and ensuring compliance with federal and state notification requirements. We provide a full suite of services to protect your organization and your patients' data from evolving cyber threats.

We review and negotiate physician employment agreements, medical staff bylaws, and restrictive covenants to ensure legal compliance and alignment with business goals. Our experience in this area allows us to anticipate common issues and draft agreements that protect your organization's interests while maintaining fair and sustainable relationships with your medical staff. We also provide guidance on the complex credentialing process to ensure your providers are properly vetted and authorized to practice.

Our attorneys help healthcare institutions maintain compliance with complex wage and hour rules, whistleblower protections, anti-discrimination statutes, and OSHA standards. This is especially relevant in the post-COVID-19 environment, where new workplace safety regulations and labor dynamics have emerged. We provide proactive counsel to help you develop and implement sound employment policies that protect your organization and foster a positive work environment.