Pepper Hamilton LLP is experienced in the pharmacy industry. We help pharmacy clients conduct business transactions, resolve disputes and navigate government regulation so that they can grow and prosper. Whether you are seeking capital, restructuring your business, resolving regulatory matters, dealing with workforce issues, trimming your tax burden or settling a dispute, chances are a Pepper lawyer has already handled a case or transaction like yours.
Our clients include a wide range of retail, specialty compounding and long-term care pharmacies, as well as pharmacy group purchasing organizations, pharmacy networks and other industry entities. Our work for pharmacy clients also is enhanced by our strong practice representing health care providers and investors, and our nationally recognized practice representing pharmaceutical and medical device manufacturers, and a wide range of biotechnology and other life sciences companies.
Below is an outline of the services we most frequently provide to pharmacy industry clients.
We assist clients with mergers and acquisitions, joint ventures and partnering arrangements, restructurings and reorganizations, dispositions and carve-outs, and venture capital and other transactions. We also advise clients on a wide range of agreements with vendors, suppliers, payors, PBMs, PDPs, wholesalers and customers. We are experienced in advising pharmacy clients on the regulatory compliance issues attendant to transactions, including fraud and abuse issues, safe harbor regulations, and regulatory issues impacting relationships with other participants in the medical supply chain.
We represent pharmacies in dealing with regulatory issues affecting commercial health care transactions as well as those involving members in the medical and pharmaceutical supply chains, including pharmaceutical and medical device manufacturers and suppliers, hospitals, physicians, GPOs, outsourcing companies and other providers.
These issues generally fall under fraud and abuse laws, (including the federal Anti-Kickback Statute), Stark, civil monetary penalties law, the False Claims Act, health care fraud statutes and the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
We also assist retail, specialty and long-term care pharmacies, and other health care entities in dealing with billing, reimbursement and claims issues, including issues under Medicare Parts A, B and D, Medicaid and commercial payor requirements.
We advise clients about their membership in or relations with group purchasing organizations, including advice about compliance with the federal Anti-Kickback Statute, and how to take advantage of the “safe harbors” that may be available.
We also advise on the federal and state law regulatory issues affecting the practice of pharmacy. Certain purchasers, such as health plans and PBMs, use formularies to promote safe, effective and cost-effective drug use. The U.S. Office of the Inspector General has identified several PBM practices as potential risk areas, including relationships with formulary committee members, payments to PBMs, and formulary placement payments.
We counsel, advise and represent third-party administrators of prescription drug programs in dealing with issues of competition, regulation, and transparency, and help these purchasers carefully evaluate and structure those relationships to avoid government scrutiny.
We have significant experience in representing developers and property owners in the acquisition, financing and development of real estate, including retail pharmacy properties. Our experience includes all aspects of site acquisition, including title, purchase agreements, joint development agreements, reciprocal easement agreements, access agreements, all types of municipal agreements, and developer agreements with municipalities for the site and access to sewer and water.
We analyze the easiest way to obtaining zoning, land use approvals and highway occupancy approvals, and follow through to completion of the development. After construction, we work with the municipality to see that all required conditions for approval are met and that any operations issues are addressed. In addition to land use and zoning approvals, we assist clients in obtaining environmental permits from federal and state authorities.
Retail Health Clinics
Consumers’ use of retail health clinics is increasing. We help clients interested in sponsoring or operating such clinics to navigate the financial, legal and marketplace issues for involvement in convenient care and help forge alliances and agreements between the clinics and hospitals, physicians, and other health-care entities. We help physicians who partner with retail care centers as a means of providing a collaboration and referral system for patients who use the clinics, and assist the centers in responding to and complying with increasing calls from physician associations and medical standards groups for increased regulation of this growing industry.
Litigation and Enforcement
We have represented pharmacy clients in a wide range of litigation matters, from commercial disputes to consumer class actions and employment matters. We also have significant experience representing pharmacy clients in investigations, audits and enforcement actions by state and federal regulators.