Benjamin M. Daniels

Special Counsel

Overview

Benjamin M. Daniels is a special counsel and business lawyer with Foley & Lardner LLP. He focuses his practice in the health care field, and has in-depth knowledge of federal and state regulation of laboratories, the drug and device supply chain, and pharmacies. He advises health care providers, investors, and lenders on transactional matters and regulatory compliance, including mergers and acquisitions, recapitalizations, buyouts, restructurings, joint ventures, and broad range of commercial transactions. Ben also advises clients on a wide range of health care regulatory matters, including compliance, government investigations, reimbursement, licensure, and research operations. He is a member of the firm's Health Care Practice as well as the firm’s Health Care Industry Team.

Prior to returning to Foley, Ben served as Assistant General Counsel at Fresenius Kidney Care, where he counselled several Fresenius business lines that complement the company’s core dialysis focus, including its laboratory, pharmacy, wholesale drug and device distribution, and operations. His imbedded experience allows Ben to understand and carefully balance the business goals of his clients with the complex regulatory environments in which they operate.

Ben’s work covers a wide range of pharmacy matters including:

  • Retail and Specialty Pharmacies: Represented numerous retail and specialty pharmacies on regulatory issues, including state Boards of Pharmacy inspection and adverse findings, compounding pharmacy matters, and licensure among others. Represented investors both venture capital and private equity) in pharmacy investments, acquisitions and sales.
  • Prescription Drug Supply Chain – Wholesalers and Third Party Logistic Providers: Represented prescription drug and device wholesalers and third party logistics providers on a variety of issues related to regulatory compliance, licensing, and transactions.
  • Telepharrmacy and Digital Health: Ben advises suppliers, providers, consultants, vendors, and a variety of other health care entities on a range of business, legal, and regulatory issues affecting the telemedicine industry. He advises on controlled substance prescribing, multi-state licensure, practice of pharmacy restrictions and regulations, direct to consumer medication sales, patient freedom of choice, and state and federal fraud and abuse considerations.

Education

Ben graduated from Boston College Law School (J.D., cum laude, 2010). While in law school, he worked at the Boston College Legal Assistance Bureau’s Community Enterprise Clinic as a student attorney, providing legal advice and consultation to individual and non-profit clients on a range of legal matters. Ben also earned his Bachelor of Arts in political science (summa cum laude, 2005) and his Master of Public Policy (2006) from The George Washington University.

Professional Memberships

Ben is a member of the Boston Bar Association and the American Society for Pharmacy Law. In addition, he is a member of the American Health Lawyers Association (AHLA), where he currently serves as the Education Coordinator for AHLA’s Fraud & Abuse Practice Group and as the Young Professional Delegate to the Board of Directors in 2017 and 2018.

Admissions

Ben is admitted to practice in Massachusetts.

Representative Matters*

  • Lead counsel in the acquisition of a specialty pharmacy.
  • Lead counsel in all regulatory matters for a specialty pharmacy.
  • Represented a national veterinary pharmacy in commercial arrangements with retailers and other business partners.
  • Advised an emerging digital health company in structuring and negotiating a partnership with a national mail order pharmacy to ensure seamless access to pharmacy services.
  • Advised an emerging telemedicine company on how to vertically integrate pharmacy revenue in connection with its direct-to-consumer telemedicine offerings. The work involved advice on multi-state licensure, practice of pharmacy restrictions and regulation, direct to consumer medication sales, patient freedom of choice, and state and federal fraud and abuse considerations.
  • Represented a digital health company in analyzing state laws governing the prescribing of controlled substances via telemedicine. Advised the company on state and federal regulation of controlled substance prescribing, including state medical and controlled substance licensure, federal DEA controlled substance registrations, as well as requirements to create a valid prescriber-patient relationship.
  • Advised a start-up digital health provider to structure a concierge medicine service that included analysis of corporate practice of medicine issues, state licensure and regulations, and state and federal fraud and abuse compliance.
  • Advised a regional health system in its acquisition of a retail urgent care provider.
  • Assisted in providing health care regulatory compliance advice related to various mergers and acquisitions of a major life science client.
  • Advised hospital client in regulatory matters associated with the formation of a clinical integration organization.
  • Advised private equity client in the acquisition of a multi-state hospice provider.
  • Assisted in representation of a private equity client in the $750 million sale of an ancillary health care services company to a strategic buyer.
  • Provided formation and ongoing commercial and regulatory advice to an anesthesia services company.
  • Advised home health services client on regulatory and transactional matters related to a joint venture with a major hospital system.
  • Advised a mobile health company with regulatory compliance and approvals associated with its technology.
  • Assisted private equity client in the merger of its portfolio company with a target, with the resulting company becoming one of the largest suppliers of custom durable medical equipment in the country.
  • Assisted in the representation of a major oncology practice client’s asset sale and subsequent hospital affiliation.
  • Advised hospital client in establishing a joint venture ambulatory surgery center.
  • Advised hospital on establishment of a 340B pharmacy.
  • Advised skilled nursing facility client on regulatory compliance in multiple states associated with the client’s employing of mid-level practitioners in its facilities.
  • Assisted hospital client in negotiating managed care contracts with payors.
  • Advised hospital system on improving data security policies and procedures following a significant data loss.
  • Assisted in representation of private equity client in $260 million acquisition of plastic products manufacturer and associated debt financing.
  • Advised private equity client on health care regulatory matters associated with $100 million sale of addiction treatment centers.
  • Member of team representing private equity client in $34 million acquisition of air ambulance company.
  • Assisted private equity clients in acquisitions and sales of various addiction rehabilitation services companies.
  • Advised financial services client on regulatory matters related to Medicare and workers’ compensation settlements.
  • Advised board of public energy company on benefits and challenges presented by adopting majority voting elections of directors.

*Certain of these matters occurred prior to Ben joining Foley & Lardner LLP.

Selected Publications and Presentations

  • “Key Considerations in Telepharmacy Compliance,” Compliance Today, August 2018
  • “The Battle Over Drug Pricing: First Shot Targets Pharmacy Benefit Managers,” Health Care Law Today, July 2018
  • “Legal Issues Affecting Pharmacies-A Look at Mishaps and Enforcement Actions in the Pharmacy Industry,” AHLA Annual Meeting, June 2018
  • “Pricing Governance and Anticipating Fraud and Abuse Risks in Light of the Current Pricing Debate,” 18th Annual Conference on Fraud and Abuse, March 2018
  • “From Dispensers to Dispensaries: Legal Issues Affecting Pharmacies and Medical Marijuana Businesses,” American Health Lawyers Association’s Fundamentals of Health Law Conference, November 2017
  • “Could a Recent CMS Deregulation Regulation Save Health Care Providers $8 Billion?” Health Care Law Today, May 2014; DRI’s Medical Liability and Law Digest; retweeted via JD Supra’s Health Law Twitter Feed
  • “The Current State of Mobile Health Application Regulation – A Balance of Achieving Safety and Encouraging Innovation,” Health Care Law Monthly, May 2014
  • “Obama Announces Affordable Care Act Enrollment Crosses into the 8 Million Mark,” Health Care Law Today, April 2014
  • “Finally….FDASIA Health IT Regulation Report Released,” Health Care Law Today, April 2014
  • “The Need to Know of Due Diligence,” AHLA Presentation, April 2014
  • “The Supply Side of Health Care IT: Notes from the Experts,” Emerging Company Exchange – Healthcare: IT Issues, February 2014
  • “What’s Health Law got to do with it,” AHLA Presentation, January 2014
  • “The New Era of Healthcare Joint Ventures,” The Deal Pipeline, January 2014

Ben is also a regular contributor to AHLA’s Teaching Hospital and Academic Medical Center weekly updates.

Representative Matters

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Foley advised a research hospital in establishing remote prescription dispensing facilities in rural communities. The remote dispensing facilities enable patients to fill prescriptions in areas with no immediate access to retail pharmacies, giving patients direct access via telemedicine technology to remote pharmacists. Foley’s work included comprehensive analysis and solutions related to licensure, remote pharmacy monitoring, practice of pharmacy, electronic prescribing, patient consent, and state and federal fraud and abuse considerations.
Foley advised an emerging digital health company in structuring and negotiating a partnership with a national mail order pharmacy to ensure seamless access to pharmacy services. The company enables physicians to engage with patients remotely through the use of telemedicine. Foley’s advice to the company included comprehensive analysis and solutions related to licensure, practice of pharmacy, electronic prescribing, patient consents and both state and federal fraud and abuse considerations related to partnering with a third party pharmacy.
Foley represented a digital health company in analyzing state laws governing the prescribing of controlled substances via telemedicine. The company offers patients direct access to psychiatric services via a telemedicine platform. Foley advised the company on state and federal regulation of controlled substance prescribing, including state medical and controlled substance licensure, federal DEA controlled substance registrations, as well as requirements to create a valid prescriber-patient relationship.

Capabilities