Our Health Law attorneys have extensive experience with health care fraud and abuse law and health regulatory issues.
We represent diverse sectors of the health industry, including hospitals, outpatient facilities, IPAs, ACOs, physicians, dentists, pharmacists, nursing homes, assisted living facilities, home health agencies, MSOs and medical suppliers. Our practice covers the following core health law areas:
Health Law Regulations
- Facility licensure, regulation and Certificate of Need (CON) applications
- Certificates of Public Advantage (COPA) and regulatory waivers to accommodate value based contracting programs
- Medical records and regulation of protected health information (HIPAA)
- Medical staff credentialing and privileges
- Managed care contracting, including value based contracting and other Delivery System Reform Incentive Payment (DSRIP) programs
- Antitrust law and restrictive covenants
- Compliance with state and federal laws regulating the practice of telemedicine
- Professional malpractice and misconduct, medical consent
Fraud and Abuse
- Anti-kickback statutes and safe harbors, and fee splitting laws
- The Stark Law and state self-referral laws
- Corporate practice of medicine and scope of practice issues
- Medicare and Medicaid reimbursement rules
- False Claims Act, including “whistle blower” cases
- Corporate compliance programs and white collar criminal defense
Corporate/Commercial
- Corporate structuring, formation and governance, payment program structuring and asset protection
- Tax counseling, including for tax exempt organizations
- Stockholder, LLC, partnership, and employment agreements
- Buy-sell agreements for equity and asset deals
- Health care contracts, including agreements for clinical and administrative services, clinical trial agreements, business associate agreements, and professional consulting services agreements.
- Clinical trial agreements and regulations governing performance of clinical trials
- IT product and service agreements, marketing-related agreements, and other agreements related to the provision of clinical care and operation of healthcare facilities
- Hospital-physician contracts, individual employment agreements, and joint ventures
- Medical service and supplier contracts, and other purchasing and financing agreements
- Medical office leasing, license agreements, and other real estate transactions
- Not-for-profit corporation law
Representative Matters
Outside Counsel
- Served as corporate compliance counsel and outside corporate counsel to multispecialty practice with 280 physicians practicing at over 30 offices in New York and Connecticut.
- Served as outside regulatory and compliance counsel to a large IPA participating in New York State’s Medicaid VBP Innovator Program.
- Acted as health law and corporate counsel to companies that provide medical billing and revenue cycle management services.
- Served as health law and outside corporate counsel to diagnostic and treatment (D&T) centers on reimbursement, physician compensation and contracting, and corporate compliance matters.
- Served as outside counsel to ambulatory surgery centers.
- Acted as corporate and healthcare counsel for multiple hospitals on technology agreements and other intellectual property matters.
- Represented IPAs and medical practices on regulatory issues, including antitrust and fraud and abuse laws, and corporate restructuring in connection with their transition to new care delivery models, including VBP under DSRIP program and Medicaid/Medicare managed care arrangements.
Transactional
- Represented Ambulatory Surgical Center in sale of its assets for $14 million.
- Represented hospitals in negotiations with equipment manufacturers for state-of-the-art medical equipment, including surgical robots and radiology equipment.
- Represented ophthalmology practice, including optometry practice, in sale of its assets to hospital system for $1 million.
- Represented home health agency in sale of its assets for $925,000.
- Represented buyers of radiology centers for $2.8 million and $1.85 million.
- Represented medical practices and hospitals in negotiations with vendors for billing and collection software and services.
- Advised medical practice in the establishment of infusion center with hospital.
- Represented technology vendor in drafting and negotiating $3 million service agreement with a PPS in the DSRIP program.
- Advised radiology practice on joint venture with hospital to establish an imaging center.
- Represented multi-office physical therapy practice in sale of assets for $12.7 million.
Fraud and Abuse
- Defended multiple healthcare providers in actions and investigations of alleged violations of billing requirements, overpayment demands, HIPAA and healthcare fraud and abuse laws.
- Represented numerous physician groups, ASCs, hospitals and D&T centers on issues arising under Stark Law, anti-kickback statute, false claims act and other healthcare fraud and abuse laws, including how to structure arrangements to comply with such laws and requesting Office of Inspector General (OIG) Advisory Opinions.
- Prepared OIG Advisory Opinion requests for proposed business arrangements under federal anti-kickback statute and other OIG sanction statutes.
- Represented physical therapy group in successful recovery of $480,000 from commercial payors for improper out-of-network payments.
- Advised various healthcare providers on self-disclosure processes and prepared submissions under the OIG’s and the Office of Medicaid Inspector General’s (OMIG)’s Provider Self-Disclosure Protocol to report potential fraud.
- Represented medical practices and hospitals in CMS meaningful use audits.
- Represented pharmaceutical companies in government investigations and False Claims Act litigation relating to government price reporting and Medicaid reimbursement issues.
Regulatory
- Represented Performing Provider System (PPS) under New York’s DSRIP program comprised of over 4,000 medical providers.
- Advised large multistate pathology laboratory in establishment and growth of technical component/professional component (TC/PC) arrangements between pathologists and physician groups.
- Represented and advised management companies in providing administrative services, equipment and property to medical practices.
- Represented company in its establishment and sale of a dental implant imaging business that contracted with dental and imaging centers throughout New York City metropolitan area.
- Counseled providers in appropriate reporting of data breaches to the Office of Civil Rights (OCR), state authorities and affected patients and conducted internal investigations and HIPAA Security Audits.
- Represented large psychiatric medical practice in structuring professional service arrangements with associated psychologists and other therapy providers.
- Counseled hospital and physician groups on development of clinically integrated network for joint payor contracting in compliance with antitrust laws.
- Drafted HIPAA security and privacy policies for covered entities and business associates.
- Developed and updated compliance policies and procedures to align with changing regulations and industry best practices.
- Represented and advised physicians and physician groups on a variety of legal and compliance issues related to the Anti-Kickback Statute, Stark Law, state licensure, reimbursement, HIPAA, performance of clinical trials, medical record requests, and delivery of patient care.
Bleakley Platt is committed to our clients’ success and believes that in some instances, an alternative fee arrangement may be preferable to a traditional hourly fee structure. Such arrangements require approval by the Firm’s management. To learn more about the Firm’s policy regarding alternative fee arrangements, click here or speak with a partner.
