We understand that the current economic and legislative climate in the health care industry presents new business, legal and ethical challenges. We keep abreast of developments in Federal and Puerto Rico laws and regulations affecting healthcare facilities, drug products, medical devices, medicinal cannabis, medical insurance and health care tax incentives.
Much of our time is spent representing clients before the Puerto Rico Health Department and before legislative committees and government agencies impacting the health field. With our experience and understanding of the industry, we offer strategic advice to help clients meet these challenges, and achieve and maintain success in the highly competitive health care marketplace.
The practice team attorneys provide creative legal, regulatory and business solutions to a broad spectrum of health businesses and professional clients involved in the provision and financing of health care and related services. Our team is formed of attorneys in all areas of legal practice, including labor and employment law, corporate, real estate, taxes, environmental, insurance, retirement plans and employee benefits. We also have attorneys experienced in helping clients with government strategies, compliance, audits and investigations. This multidisciplinary nature of our team allows us to provide cost effective services for all types of health-related transactional and regulatory work.
We have experience representing all critical sectors of the healthcare industry, regularly providing advice on regulatory and compliance issues, including matters related to the registration of medical devices and drug products (including controlled substances) with the Puerto Rico Department of Health, and licenses and permits for out-of-state entities in the drug supply chain (e.g., manufacturers, third party logistics companies, wholesale distributors and pharmacies). We counsel hospitals, management service organizations (MSOs), dialysis centers, hospices, ambulatory surgical centers, clinical laboratories, medical devices and drug manufacturers, and Puerto Rico and out-of-state pharmacies and distributors, as well as physician’s practices and pharmacy benefit managers. We also assist clients manage the dynamic medicinal cannabis legal landscape.
McConnell Valdés represents clients on certificate of need (CON) proceedings, and provides advice on health care facility development, financing and operation, commercial agreements, antitrust, licensing, and certification. Moreover, we design and implement strategies for integrated delivery systems, IPAs, and other physician joint ventures, acute and long-term care providers, and ancillary service providers. We also represent a broad range of providers and payors on compliance matters involving the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as Centers for Medicare & Medicaid Services (CMS) and U.S. Federal Drug Administration (FDA) regulations.
Many health care clients come to us because of our skill in negotiating and drafting health facility management agreements, professional service and independent contractor agreements, and asset purchase agreements.
Our lawyers also work closely with clients to develop the procedures and documentation that allow them to avoid litigation. When litigation is unavoidable, our attorneys aggressively defend our clients in health care and all related matters in the courts. We also represent clients before government agencies such as the Puerto Rico Department of Health, the Office of the Insurance Commissioner, and the Department of Consumer Affairs.
News & Publications
- An McV health Care AlertOctober 31, 2023
- PR Department of Health Issues Regulation for Clinical Laboratories, Blood Banks and Plasmapheresis CentersAn McV Health Care AlertOctober 13, 2023
- An McV Health Care AlertJune 23, 2023
- An McV Health Care AlertNovember 8, 2022
- Non-Resident U.S. Distributors Now Required to Obtain Special Authorization to Distribute Medications and Medical Devices in Puerto RicoAn McV Health Care AlertJuly 14, 2022
- Important Amendments to Regulation No. 156 Approved for Establishments that Manufacture, Distribute and Dispense Medications and Medical Devices in Puerto RicoAn McV Health Care AlertMarch 24, 2022
- An McV Health Care AlertJune 8, 2021
- Important Amendments to Regulation No. 156 Announced for Establishments that Manufacture, Distribute and Dispense Medications and Medical Devices in Puerto RicoAn McV Health Care Practice Team AlertOctober 21, 2020
- An McV Health Care Practice Team AlertSeptember 2, 2020
- An McV Tax & Health Care AlertJuly 1, 2020
- An McV Tax & Health Care AlertMay 5, 2020
- Puerto Rico Department of Health Extends Validity of Licenses, Permits and Certificates Expiring During COVID-19 EmergencyAn McV Health Care AlertApril 13, 2020
- Puerto Rico Department of Health Relaxes Certificate of Need and Convenience Requirements for Hospitals Seeking to Add Patient Beds During the COVID-19 CrisisAn McV Health Care AlertMarch 30, 2020
- An McV Health Care Practice Team AlertAugust 20, 2019
- An McV Health Care Practice Team AlertJune 11, 2019
- An McV Corporate & Health Care AlertJune 20, 2018
- An McV Health Care AlertOctober 13, 2017