Healthcare Regulatory & Compliance Counseling
AEL provides expert healthcare regulatory counsel to providers, institutions, technology companies, and startup ventures. With a bench that includes former in-house regulatory counsel for one of the largest, most prestigious academic health and hospital systems in the country, we regularly advise healthcare clients on how to structure and operate their businesses in compliance with federal and state rules governing health care delivery and compensation, including: the “Stark” law; the Antikickback Statute; Medicare Conditions of Participation; HIPAA; Telehealth/Telemedicine rules and regulations; the FDCA and other FDA regulatory regimes; and state corporate practice of medicine rules. We help clients negotiate and structure legally compliant arrangements with providers, hospitals, physician groups, independent practice associations (IPAs), management services organizations (MSOs), technology companies, and drug and device manufacturers. We create, maintain, and enforce internal compliance programs. And we work with providers to develop innovative care delivery models and to structure value and savings-based payment arrangements.
Representative Matters – Regulatory Advising
- Furnished regulatory advice to academic medical center, hospitals, and physician practices regarding both routine and non-routine compliance, billing, and reimbursement issues.
- Advised healthcare technology startup on how to structure business operations as well as arrangements with healthcare providers to comply with the federal Antikickback statute, HIPAA, and New York and New Jersey state-based healthcare regulations and requirements.
- Advised hospitals and providers on how to structure arrangements with referring physicians, including professional service agreements (PSAs), license and service agreements (LSAs), and employment arrangements, to comply with the Stark law, the Anti-kickback law, and other applicable regulatory requirements.
- Counseled noted health and wellness company on compliance with FDA rules and requirements regarding branding, marketing, and advertising of cosmetic products.
- Conducted reviews and risk assessments for academic medical centers, hospitals, and physician practices to remediate compliance program gaps and enhance effectiveness of program activities to meet obligations under applicable laws, CAPs and CIAs, and industry best practices.
- Advised healthcare startup entities on compliance with state corporate practice of medicine restrictions and other state-based licensure requirements.
- Counseled hospitals and physicians on compliance with New York State “Surprise Medical Bills and Emergency Services” law and rules.
- Advised hospitals on compliance with Medicare Conditions of Participation and provider-based billing rules.
- Counseled on and prepared voluntary disclosures for hospitals regarding Medicare billing irregularities pursuant to HHS OIG Provider Self-Disclosure Protocol (SDP).
Representative Matters – Transactions and Arrangements
- Negotiated and drafted partnership agreements between health system and nationally recognized private equity backed primary care provider for provision of concierge medical services in New York metropolitan market.
- Negotiated affiliation agreement with large municipal public health care system on behalf of medical school and physician faculty practice.
- Restructured and redesigned community hospital’s “captive” PC-based ambulatory practice network and associated arrangements with hospital and medical school to improve patient care, ensure regulatory compliance, and increase operational and financial efficiencies.
- Negotiated deal terms and drafted agreements associated with physician practice acquisitions by health care systems and hospitals.
- Negotiated employment agreements, PSAs, and LSAs between physicians, physician practices, hospitals, faculty practices, and other healthcare providers.
- Represented community hospital in connection with minority-interest investment in orthopedic ambulatory surgery center.
- Negotiated commercial and IT agreements with vendors, drug and device manufacturers, and biomedical service and supply vendors.
- Designed, structured, and drafted participation agreements and program handbooks and policies for Mount Sinai Health Partners (MSHP) Trusted Rehabilitation Provider Network and MSHP Trusted Post-Acute Care Provider Networks.
Representative Matters – Healthcare Delivery and Payment Reform
- Counseled clinically integrated network (CIN) on fraud and abuse, HIPAA, antitrust, and other regulatory issues associated with clinical operations, value and shared-savings based incentive arrangements, and data sharing.
- Advised healthcare providers on best practices and risk mitigation associated with Medicare Advantage risk adjustment coding activities.
- Structured legally compliant value and shared-savings based incentive programs and participation agreements for IPA, CIN, and Medicare Shared Savings Program (MSSP) ACOs.
- Counseled MSSP ACO participants on compliance with MSSP regulations regarding contents of participation agreements, provider incentive payments, beneficiary incentives, data sharing, and waivers of application of fraud and abuse laws.
- Advised healthcare providers on rules and requirements for participation in government sponsored alternative payment models, including the MSSP, Bundled Payments for Care Improvement (BPCI), the Comprehensive Care for Joint Replacement Model (CJR), and the Oncology Care Model (OCM).