Stacey L. Gulick
Partner
516-393-2264
Regulatory Health Care Law
- Overview
- Attorneys
- Insights
Our Regulatory Practice Group guides clients through the complex landscape of health care regulations, positioning them to leverage regulatory opportunities while avoiding or successfully addressing compliance challenges. Our cross-disciplinary team of experienced attorneys provides comprehensive counsel across the entire health care spectrum, from large hospital systems to solo medical practices, as well as telehealth, life sciences, and biotechnology innovators. We work closely with clients to ensure adherence to federal and state regulations, developing strategies to maximize opportunities, manage risks, and align with governmental policies, allowing clients to focus on delivering quality patient care.
Our in-depth knowledge and tailored solutions offerings include:
-
Guidance on Telemedicine and Emerging Health Technologies
- Staying at the forefront of legal developments in telehealth, e-health, and virtual care, we help clients meet licensing and regulatory requirements.
-
Licensing and Certification Support
- Our team assists health care professionals in obtaining and maintaining licenses, navigating state board requirements, and addressing potential disciplinary actions.
-
Regulatory Affairs
- We work closely with a wide range of health care providers, organizations, and stakeholders to navigate state and federal regulatory schemes to structure compliant management and ownership models, as well as provide counsel concerning corporate practice of medicine (CPOM) prohibitions and fee-splitting restrictions, and mitigating fraud and abuse risk.
-
Transactional Advice
- We advise on the regulatory aspects of health care transactions, including mergers, acquisitions, joint ventures, and restructurings for hospitals, physician practices, ambulatory surgery centers, long-term care providers, dental practices, and other health care entities.
-
Management Services Organizations
- We assist in structuring the relationships between providers and management services organizations which contain regulatory concerns which vary on a state by state basis. Our clients include both provider networks and equity and non-equity-backed MSO platforms.
By collaborating with specialized practice groups within Garfunkel Wild—such as Investigations, Audits and Regulatory Compliance; HIPAA, Privacy, and Risk Management; Clinical Trial/Research; and Technology and Cybersecurity —we deliver best-in-class service and industry insight, helping clients achieve their business objectives.
Practice Group Contacts
Team
Potential Shift in RPM Services
CMS has proposed significant changes to Medicare payment and coverage policies for remote patient monitoring and remote therapeutic monitoring beginning in calendar year 2027. The proposed rule would substantially limit the use of third-party personnel in furnishing billable remote monitoring services, expand existing patient eligibility requirements, and establish a mandatory initiating visit.
What New York Community-Based Organizations Need to Know Before August 21
The New York State Department of Health has published a Full Public Notice requesting a five-year extension of the Section 1115(a) Medicaid Redesign Team demonstration, which expires March 31, 2027. While the State proposes to continue the full scope of Health-Related Social Needs services delivered through Social Care Networks, two structural changes could fundamentally reshape the funding landscape for community-based organizations: the end of federal infrastructure funding (including CBO capacity building grants) and a transition from non-risk payments to risk-based capitated funding controlled by Managed Care Organizations.
Our Regulatory Practice Group guides clients through the complex landscape of health care regulations, positioning them to leverage regulatory opportunities while avoiding or successfully addressing compliance challenges. Our cross-disciplinary team of experienced attorneys provides comprehensive counsel across the entire health care spectrum, from large hospital systems to solo medical practices, as well as telehealth, life sciences, and biotechnology innovators. We work closely with clients to ensure adherence to federal and state regulations, developing strategies to maximize opportunities, manage risks, and align with governmental policies, allowing clients to focus on delivering quality patient care.
Our in-depth knowledge and tailored solutions offerings include:
-
Guidance on Telemedicine and Emerging Health Technologies
- Staying at the forefront of legal developments in telehealth, e-health, and virtual care, we help clients meet licensing and regulatory requirements.
-
Licensing and Certification Support
- Our team assists health care professionals in obtaining and maintaining licenses, navigating state board requirements, and addressing potential disciplinary actions.
-
Regulatory Affairs
- We work closely with a wide range of health care providers, organizations, and stakeholders to navigate state and federal regulatory schemes to structure compliant management and ownership models, as well as provide counsel concerning corporate practice of medicine (CPOM) prohibitions and fee-splitting restrictions, and mitigating fraud and abuse risk.
-
Transactional Advice
- We advise on the regulatory aspects of health care transactions, including mergers, acquisitions, joint ventures, and restructurings for hospitals, physician practices, ambulatory surgery centers, long-term care providers, dental practices, and other health care entities.
-
Management Services Organizations
- We assist in structuring the relationships between providers and management services organizations which contain regulatory concerns which vary on a state by state basis. Our clients include both provider networks and equity and non-equity-backed MSO platforms.
By collaborating with specialized practice groups within Garfunkel Wild—such as Investigations, Audits and Regulatory Compliance; HIPAA, Privacy, and Risk Management; Clinical Trial/Research; and Technology and Cybersecurity —we deliver best-in-class service and industry insight, helping clients achieve their business objectives.
Practice Group Contacts
Team
Potential Shift in RPM Services
CMS has proposed significant changes to Medicare payment and coverage policies for remote patient monitoring and remote therapeutic monitoring beginning in calendar year 2027. The proposed rule would substantially limit the use of third-party personnel in furnishing billable remote monitoring services, expand existing patient eligibility requirements, and establish a mandatory initiating visit.
What New York Community-Based Organizations Need to Know Before August 21
The New York State Department of Health has published a Full Public Notice requesting a five-year extension of the Section 1115(a) Medicaid Redesign Team demonstration, which expires March 31, 2027. While the State proposes to continue the full scope of Health-Related Social Needs services delivered through Social Care Networks, two structural changes could fundamentally reshape the funding landscape for community-based organizations: the end of federal infrastructure funding (including CBO capacity building grants) and a transition from non-risk payments to risk-based capitated funding controlled by Managed Care Organizations.