Healthcare Regulatory & Compliance Counseling
AEL has been recognized two years in a row by the independent international rating company Chambers USA as a leading law firm for Healthcare. In 2022, each of AEL’s partners – Kenneth M. Abell, David M. Eskew, and Scott R. Landau – were individually recognized by Chambers as leading attorneys in Healthcare. Partner Scott R. Landau was described by clients as a “terrific lawyer; very knowledgeable, practical and easy to work with.”
AEL provides expert regulatory and transactional counsel to clients in the healthcare industry. We advise on strategic transactions and arrangements regarding both day-to-day operations, as well as in extraordinary regulatory and compliance issues.
In our healthcare regulatory and compliance practice, we counsel clients on how to structure and operate their businesses in compliance with federal and state rules governing healthcare delivery and compensation, including: the “Stark” law; the Antikickback Statute (AKS); EKRA; 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 design internal compliance programs and perform gap analyses and risk assessments for providers and practices.
And we represent and counsel institutions and providers in connection with administrative inquiries and insurance audits regarding complicated regulatory compliance and billing questions.
Representative Matters – Regulatory Advising
- Examining and analyzing proposed arrangements on behalf of national telehealth company to ensure compliance with federal fraud and abuse laws as well as state-based corporate practice and fee-splitting prohibitions.
- Advising providers and MSOs on regulatory compliance and billing/reimbursement issues in connection with COVID-19 testing and vaccination operations.
- Representing private practice in state DOH and insurance company inquiries regarding complicated commercial claims coding and reimbursement questions related to orthopedic procedures.
- Counseling Article 28 DTC on complicated Medicaid managed care reimbursement and billing issues.
- Counseling noted health and wellness company on compliance with FDA rules and requirements regarding labeling, branding, marketing, and advertising of dietary supplements.
- Advising telehealth startup venture on regulatory and compliance with state-based licensure requirements and fee-splitting restrictions.
- 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
- Representing Ambulatory Surgery Centers (ASCs) in equity and asset sale transactions with private equity backed ventures.
- Negotiating arrangements between management services organizations (MSOs) and diagnostic treatment centers (DTCs), physician practices, and clinical laboratories regarding provision of general management services as well as COVID testing related administrative services.
- Developing and negotiating complicated license and service, management, and real estate transactions with large regional hospital on behalf of a specialty physician group practice.
- Structuring complex employment and real estate license arrangements with internationally renowned medical school on behalf of a private physician practice.
- Negotiating data aggregation and research usage agreements with large academic medical centers on behalf of healthcare data aggregation concern.
- Restructuring and redesigning 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 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.
- 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).