Regulatory & Compliance

Benesch Healthcare+ handles regulatory matters relating to Medicare and Medicaid reimbursement, private insurance, antitrust, federal and state fraud and abuse laws, licensure, and survey and certification. We evaluate transactions from a health care perspective and with a knowledge of how health care facilities operate on a day-to-day basis.

The federal and state health care fraud and abuse laws are both comprehensive and complex. Members of the Benesch Healthcare+ Practice Group are extremely conversant with the (1) federal anti-kickback statute, safe harbor regulations, case law, Office of Inspector General (“OIG”) advisory opinions, “fraud alerts” and other issuances by the OIG and the Centers for Medicare and Medicaid Services (“CMS” (formerly the Health Care Financing Administration); (2) “Stark” (physician self-referral) statute, regulations, case law and advisory opinions; (3) federal statutes establishing criminal offenses and grounds for civil monetary penalties and exclusion under the federal Health Care Programs; (4) federal False Claims Act and case law (including matters relating to private “whistleblower” actions); and (5) OIG Voluntary Disclosure Protocol.  By drawing on our vast contacts within the health care industry, we have keen insight into the emerging trends and proposed regulations that impact your business. We can anticipate how potential industry changes might affect your prospects and legal risks and will counsel you on them so you can improve and protect your business and take advantage of new opportunities. Our industry connections also allow us to be advocates for our client’s business. Knowing how heavily regulated the health care industry is, we proactively build relationships with those who influence those regulations: industry leaders and their entities, legislative and regulatory bodies, and individual legislators and regulators. We can then amplify our clients’ voices on matters crucial to their success by furnishing industry leaders with insight on how proposed laws, rules and regulations might hurt or help the industry. We assist clients with compliance-related matters such as conducting internal investigations, drafting policies and procedures, implementing compliance programs, and training management and sales forces.

Representative matters handled include:

• Serve as health care transactional and regulatory counsel to numerous national and regional home health care and hospice providers in M&A, corporate governance, compliance, reimbursement and regulatory matters.
• Serve as regulatory counsel for numerous and regional long-term care providers, including nursing homes, CCRCs, MRDD residential care providers and dialysis facilities.
• Represent national and regional providers of health care services in connection with OIG, DEA, DOJ, State Attorneys General, UPIC, 2PIC, RAC and Medicaid fraud and abuse lawsuits; and in settlement negotiations and drafting of corporate integrity agreements.
• Represented a private equity fund on health care transaction and regulatory matters in connection with its acquisition of a national managed health care preferred provider from a foreign information technology enterprise focused on the health and financial services sector.
• Represented a large retail pharmacy chain in numerous federal and state regulatory and reimbursement issues.
• Represented a private equity fund in health care due diligence and regulatory matters in the purchase of a publicly-held pharmacy chain in New York City.
• Served as regulatory counsel for the sale of Duane Reade to Walgreens.
• Represented North Suburban Pain and Spine as healthcare regulatory counsel, in the preparation of the Certificate of Need application for the establishment of an Ambulatory Surgical Center and as transactional counsel to work on issues related to stark and anti-kickback analysis. Presented application before Illinois regulatory board and worked with facility to obtain licensure and accreditation for facility.
• Counseled Meadows Mennonite Retirement Community with respect to licensing and regulatory guidance throughout the COVID-19 pandemic.
• Represented UnityPoint Health – Trinity to obtain regulatory approval to close rehabilitation unit and establish free standing rehabilitation hospital in Moline, IL.
• Represented Visavis Health Care Medical Group, as healthcare regulatory and transactional counsel, in all legal matters with a focus in New York and New Jersey, such as in connection with formation of a management services organization and corresponding medical group, ongoing regulatory guidance in connection with telehealth matters and remote patient monitoring arrangements, drafting services agreements, employment agreements and corporate formation documentation.