HEALTH AND PHARMACY LAW

Health Law

The Health law attorneys at FisherBroyles apply an integrated approach to assist our clients in addressing the multifaceted and complex issues that face a wide range of health care industry organizations, personnel, and ancillary health care service providers. Health law deals with the many legalities that affect all segments of the health care industry, including hospitals, physician groups, nursing homes, assisted living facilities, and medical device inventors, manufacturers, distributors, and third-party logistics providers, among others. Our attorneys deliver a wide array of legal skills coupled with a thorough knowledge of the industry and a keen understanding of new developments and their implications.

We are actively involved in industry organizations, are frequent lecturers to industry groups, and work diligently to remain at the forefront of developments in the field of health law. Our team of lawyers and legal professionals has actively participated in the drafting, lobbying, and the development of state and federal legislation. This has enabled us to contribute to and remain current of the constantly changing landscape of health care law. Most importantly, our lawyers constantly interface with their clients as business advisors or as communicators of new developments that may impact the client’s particular industry segment.

Health Law Services:

  • Structuring health care provider organizations and other ancillary service providers
  • Mergers and acquisitions among health care entities
  • Review business arrangements to minimize concerns under such fraud and abuse laws as Stark, Anti-Kickback Statute, False Claims Act and various state laws
  • Negotiation of service agreements and joint business transactions with hospitals and other health care entities
  • Assessment of Medicare and other payor reimbursement issues, audits, and related fraud investigations
  • Form and document structures such as IPAs, ACOs, and other integrated health care models
  • Representation of health care professionals in proceedings in front of state, federal, and local agencies pertaining to licensure and/or the rendering of medical and professional services
  • Representation of health care professionals in hospital or medical staff proceedings for the revocation, non-renewal, termination, suspension, modification or restriction of medical staff privileges
  • Organize, structure and implement major medical equipment and facility acquisitions (e.g. magnetic resonance imaging scanners, lithotripters and ambulatory surgical centers)
  • Prepare and negotiate employment, stock purchase and other professional practice agreements
  • Address fraud and abuse, corporate practice of medicine, fee-splitting, 501(c)(3), and antitrust issues affecting providers in business planning and regulatory compliance
  • Provide guidance on HIPAA and confidentiality issues
  • Advise clients on day-to-day patient and practice issues, personnel matters, and other routine corporate matters impacting the client’s practice or health care business
  • Assistance with the development and maintenance of compliance programs
  • Address appropriate compensation and financial relationships among health care providers

Pharmacy Law

At FisherBroyles, we take pride in our depth of knowledge and experience representing pharmacies, pharmacists, health systems and providers, drug wholesalers, technology companies and other entities involved in the drug delivery system.  Our lawyers offers significant experience across the broad scope of issues facing the industry. We understand the complex intersection of business model versus regulatory compliance.

We have extensive knowledge of all segments of the drug supply chain and assist manufacturers, distributors, retailers in all facets of legal representation. Our lawyers represent clients before the Board of Pharmacy, Department of Health, and other state level agencies.  At the Federal level we have represented clients before the U.S. Department of Justice, U.S. Office of the Inspector General, U.S. Food and Drug Administration, Centers for Medicare and Medicaid Services, and Medicaid Fraud Unit.

Our lawyers are actively involved in pharmacy industry professional organizations and are frequent lecturers to industry groups, consistently staying abreast of new developments. We maintain close communications with our clients as business advisors and transmit news of emerging issues that may impact the pharmacy industry segment. We are focused on helping our clients strategically deal with the complexities of the industry.

Pharmacy Law Services:

Pharmacy Transactional and Regulatory Matters

  • Compliance
  • DEA Registration
  • Electronic Prescribing Software
  • In-Store Clinics
  • Licensure and miscellaneous pharmacy practice matters
  • Pedigree Issues
  • Pharmacy Audits
  • Pharmacy Management Agreements
  • Pharmacy Transactions
  • Privacy and Security Issues
  • Reimbursement Matters
  • Specialty Pharmacy Matters
  • Vendor Agreements

General Corporate Services

  • Legal Entity Formation
  • Mergers & Acquisitions
  • Financing
  • Bankruptcy & Reorganization
  • Labor & Employment
  • Employee Benefits
  • Executive Compensation
  • Tax Structuring

Litigation

  • White Collar & Corporate Compliance  Defense
  • Medicare and Medicaid Fraud & Abuse
  • Elder Care & Nursing Home Liability

Governmental Affairs

  • Legal and Government Relations Issues – Federal, State, and Local

Federal Trade Commission

  • Antitrust
  • Advertising Issues

Representative Matters:

Mergers and Acquisitions / Joint Ventures

  • Represented client in the sale of a national medical billing and dermatology and cosmetic surgery business to a private equity investor
  • Represented a privately held substance abuse treatment center in the $36 million sale of its assets to a strategic buyer
  • Counseled a major hospital in the joint venture and self-development of a health and wellness center
  • Counseled a therapy company client on its multi-state national expansion
  • Represented numerous pharmacies in buy/sell arrangements, stock purchases, asset purchases and stock recapitalization ventures, among other arrangements

Compliance

  • Counseled many pharmacies on DEA, CMS, FDA and state regulatory compliance.
  • Drafted and implemented a Foreign Corrupt Practice Act and U.K. Bribery Act Compliance & Training program for a global medical device company
  • Counseled nursing home providers on regulatory compliance
  • Drafted and implemented a Health Care Fraud Compliance & Training program for ten skilled nursing facilities of a closely-held health care company
  • Drafted and implemented a HIPAA compliance program for numerous physicians groups and pharmacies
  • Drafted and implemented Fraud, Waste, and Abuse compliance training programs for independent pharmacies and national chain drugstores
  • Drafted and implemented Fraud, Abuse and Waste compliance program for numerous physicians’ groups

White Collar Litigation

  • Defended pharmacy against False Claims Civil action by Department of Justice related to Tricare reimbursements by obtaining minimal settlement.
  • Defended a physician named as a co-defendant in a Qui Tam/ False Claim suit brought by co-defendant’s former employee. The Department of Justice intervened and after aggressive motions and discovery, the client participated in a settlement agreement that excluded the client from any financial participation
  • Persuaded the Department of Justice not to intervene in a Qui Tam / False Claims Act suit involving a physician’s group and three principal physicians brought by a co-defendant’s former employee. As a result of an aggressive, trial ready defense, the whistleblower dismissed the clients from the lawsuit with prejudice
  • Represented numerous pharmacies in parallel investigations by the Department of Justice (DOJ) and Drug Enforcement Agency (DEA)
  • Defended the Director of Operations of a mobile dental lab in multi-state federal and state Medicaid fraud prosecution
  • Defended a physician and chiropractor in Stark Law investigation by the Medicaid Fraud Unit
  • Respond to and defend pharmacies and other healthcare providers against cease and desist letters from government agencies that include CMS, DEA, and FDA
  • Secured dismissal with prejudice for a client in a $20 million Qui Tam/False Claims Act lawsuit

Labor and Employment

  • Represented several large hospital groups and nursing homes in labor negotiations
  • Represented several large hospitals in discrimination and retaliation suits as well as arbitration proceedings
  • Defended a health care provider against sexual harassment claims involving hostile work environment allegations against the employer by an employee who had been fired
  • Represented medical practice against its former physician/employee and hospital for breach of non-compete and tortious interference

Litigation

  • Represented sales representatives for national medical lab testing company related to United States Department of Justice investigation.
  • Represented a global medical device manufacturer in national class action involving claims for fraud and false advertising in marketing of medical testing devices
  • Successfully represented numerous medical and pharmacy providers in obtaining a TRO in connection with provider/payor disputes including third-party audits and litigation.
  • Obtained a defense jury verdict in favor of a hospital and food manufacturer on food product liability claims
  • Defended a medical device manufacturer in claims by the FDA and state agencies on off-label use marketing

Governmental Affairs

  • Represented pharmacies and medical providers as 501(c)(6) organizations to lobby before federal and state regulatory and governmental agencies