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Healthcare Compliance and Regulatory
SJKP LLP provides tailored legal counsel to healthcare companies and investors, helping them navigate the ever-changing landscape of healthcare compliance and regulatory oversight.
Our team offers strategic guidance across all regulatory matters, from compliance and enforcement to transactions and long-term strategic planning. With deep experience in the healthcare and life sciences sectors, we help clients manage legal complexities and stay ahead of industry shifts. By combining legal expertise with practical business knowledge, we ensure operations remain efficient, compliant, and positioned for growth in an increasingly regulated environment.
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1. Medical Regulatory Counseling Across Federal and State Jurisdictions
We counsel clients on navigating federal and state healthcare regulations, including compliance with fraud and abuse laws such as the Anti-Kickback Statute and the False Claims Act. Our services also cover reimbursement, licensure, and controlled substance regulations. In addition, we advise on regulatory aspects of complex transactions such as M&A, IPOs, and joint ventures, helping clients identify risks before they become costly challenges. Our healthcare regulatory team ensures that organizations can confidently expand operations while staying aligned with evolving oversight requirements.
Medical Fraud and Abuse Compliance
Healthcare fraud and abuse remain top priorities for federal and state regulators. Our team helps companies develop, implement, and monitor internal compliance programs designed to prevent violations. We assist with responding to audits, conducting internal investigations, and representing clients in government enforcement actions and qui tam litigation under the False Claims Act. By embedding fraud prevention into compliance systems, we minimize exposure to civil penalties, criminal liability, and reputational harm, while also strengthening relationships with regulators and payors.
Insurance& Medicare Reimbursement and Pricing Strategy
Reimbursement is a cornerstone of healthcare business models. We work with clients to develop pricing and reimbursement strategies for new therapies, devices, and medical technologies. Our counsel includes compliance with federal pricing transparency rules such as the Medicaid Drug Rebate Program (MDRP) and the 340B Drug Pricing Program. We also advise on Medicare and private insurer reimbursement policies, helping clients build models that attract payor support while reducing disputes. By integrating healthcare compliance into pricing strategy, we ensure that financial goals align with regulatory standards.
2. Medical Data Privacy and Security Advisory
Healthcare data has become one of the most regulated and sensitive areas of compliance. Our team provides end-to-end counsel on data privacy and cybersecurity, including HIPAA, HITECH, and state-level regulations. We also advise on cross-border data transfers, digital health platforms, and commercialization of health IT products. With increasing regulatory focus on patient rights and data integrity, we design compliance programs that safeguard sensitive information while enabling innovation in telehealth and digital medicine.
Medical Licensing and Accreditation
Healthcare providers must comply with a web of licensing and accreditation requirements. We assist hospitals, clinics, laboratories, and telehealth providers in meeting jurisdiction-specific standards. Our services include preparing applications, coordinating inspections, and managing audits. We also provide ongoing compliance support to ensure that organizations maintain accreditation status and avoid penalties. By combining healthcare regulatory insight with operational support, we help clients meet obligations while continuing to expand their patient services.
3. Medical Regulatory Diligence in Transactions
Every healthcare transaction carries regulatory implications. We support clients in assessing compliance risks during M&A, securities offerings, joint ventures, and venture capital investments. Our due diligence process evaluates licensing, billing practices, fraud exposure, and data protection risks. By integrating healthcare compliance into deal structuring and closing, we protect investor value and minimize the chance of post-transaction disputes. Our healthcare regulatory lawyers collaborate with corporate, tax, and securities teams to deliver comprehensive transaction support.
Medical Contract Structuring and Negotiation
Contracts in healthcare are heavily influenced by regulatory requirements. We negotiate and draft service agreements, technology licenses, distribution deals, and manufacturing contracts with providers, payors, suppliers, and vendors. Our lawyers ensure that agreements comply with fraud and abuse rules, reimbursement standards, and privacy obligations. We also help clients manage risk allocation, protect intellectual property, and resolve disputes before they escalate. By embedding compliance safeguards into every contract, we protect both immediate business interests and long-term operational stability.
4. Government Agency Relations and Investigations
Healthcare organizations operate under constant scrutiny from regulators. SJKP LLP leverages deep relationships with agencies such as the HHS, CMS, OIG, OCR, and DEA to support clients in audits, investigations, and enforcement actions. We prepare clients for agency inquiries, develop proactive compliance strategies, and negotiate resolutions that minimize penalties. Our team also monitors legislative developments to help clients anticipate regulatory shifts before they take effect. By combining legal precision with insight into agency practices, we position clients to navigate government relations effectively and maintain compliance in high-stakes environments.
Responding to Investigations and Enforcement Actions
When government agencies initiate investigations, timely and strategic response is critical. We assist clients in preparing documentation, conducting internal reviews, and coordinating with regulators. Our attorneys provide representation during interviews and hearings, helping organizations demonstrate good faith and reduce exposure. With experience in handling complex investigations involving fraud, reimbursement, and data privacy, our healthcare compliance team is well-equipped to resolve matters efficiently while protecting client interests.
The information provided in this article is for general informational purposes only and does not constitute legal advice. Reading or relying on the contents of this article does not create an attorney-client relationship with our firm. For advice regarding your specific situation, please consult a qualified attorney licensed in your jurisdiction.
