Foley Hoag’s integrated team of healthcare lawyers help our clients find creative approaches to their business challenges and help strategically position them for success in the highly competitive healthcare marketplace.

Our lawyers have experience in wide range of government strategies, compliance and government investigations, litigation, and corporate transactions.

Government Strategies

Foley Hoag’s Healthcare Group includes a team of attorneys and senior health policy specialists with decades of experience in the healthcare legal and policy world. Most members of the team came to Foley Hoag after very senior positions in government service, including Staff Director of a Congressional Committee with jurisdiction over healthcare, labor, and pension law, general counsel of the U.S. Department of Health and Human Services, medical director of a Medicare contractor, and director of the fee-for-service Medicare program. Other members of the team worked in senior positions for Congressional Committees with jurisdiction over healthcare, and for the Food and Drug Administration.

The group’s practice revolves around clients who face complex regulatory or compliance challenges, particularly in the Medicare or Medicaid program, and implementation of the Affordable Care Act. Representative clients consist of medical device and pharmaceutical manufacturers; Medicare Advantage plans; Part D plans; commercial insurers; healthcare providers such as hospitals and large dialysis organizations; diagnostic companies; and trade associations representing providers and payers. The team’s strategy, reflecting its wealth of government experience, is to build ongoing relationships and work proactively with government regulators, both in the agencies and on Capitol Hill.

Some recent representations include: 

  • A pharmaceutical manufacturer whose drug, because of its FDA label, could be covered under Medicare Part B or Medicare Part D. The company sought our legal analysis over the best pathway to coverage and asked us to represent them in meetings with regulators to secure their approval for the proposed approach. In addition, we provide business strategy to the client as they begin to negotiate with Part D plans.
  • Crisis counseling for a Part D plan that faced intermediate sanctions (termination of marketing and enrollment) by the Centers for Medicare & Medicaid Services (CMS). The plan retained us to represent them in their onsite audit by CMS and to negotiate a phase-down of their operations.
  • Medicare Advantage plans currently undergoing risk adjustment data validation (RADV) audits by CMS. The scope of representation includes drafting comment letters to CMS regarding the RADV audit methodology, meetings with senior CMS officials to discuss those comments; and preparation for defensive audit and possible litigation should it become necessary when the RADV audit findings are released. 
  • A commercial insurance plan with significant questions regarding the insurance reform provisions of the Affordable Care Act. In addition, we have represented plans before government regulators as the plans attempt to comply with, and the government attempts to implement, the prohibition on pre-existing condition exclusions for children under the age of 19 in the absence of authority for open enrollment periods. 
  • A large dialysis organization that is attempting to develop business strategies and a regulatory compliance strategy for a new Medicare payment system for dialysis. This representation involved multiple discussions with regulators and the HHS general counsel’s office.

Congressional Investigations

Foley Hoag also has extensive experience in representing a wide-range of clients targeted by congressional investigations. This team of experienced professionals assists clients in developing a cost effective strategy at all stages of a congressional investigation - whether it be responding to requests for documentary evidence, maintaining an ongoing dialogue with Committee Staff, making presentations to Committee Staff, or preparing clients for formal testimony or informal Staff interviews.

Representative engagements include: 

  • Defended nationally recognized non-profit institution in Senate Committee investigation regarding alleged violations of healthcare and conflict of interest laws
  • Defended major insurance company in House Oversight Committee investigation regarding healthcare costs 
  • Defended start-up medical testing company in House Oversight Committee investigation relating to FDA regulations 
  • Defended national medical device manufacturer in Senate investigation regarding alleged violations of healthcare and conflict of interest laws 
  • Defended national educational institution in House Committee investigation regarding proposed legislative initiatives

Healthcare Compliance and Investigations

Foley Hoag assists healthcare clients in compliance efforts and defending against civil and criminal claims of fraud. On these matters, Foley Hoag’s healthcare lawyers regularly work in combination with our business crimes lawyers or other relevant specific practices and represent clients at every stage of the investigative process, from advisory and investigation/audit services to the representation of clients facing civil investigations or criminal indictments.

Given the government scrutiny applied to the healthcare marketplace, often the first priority is to work with clients to create and implement effective compliance programs. This helps to reduce their risk of criminal investigations or allegations. Federal and state investigative, prosecutorial and sentencing policies increasingly emphasize the implementation of such compliance programs.

Foley Hoag’s healthcare lawyers also conduct confidential internal audits to gauge the effectiveness of our clients’ compliance programs and practices and to investigate potential misconduct. Our business crimes lawyers, many of whom were formerly federal prosecutors, have developed aggressive strategies to defend clients from allegations of criminal and civil wrongdoing.

A sampling of relevant examples of our experience is listed below: 

  • On behalf of a client, we made the first voluntary disclosure of Medicare over-billing in New England under the Office of Inspector General’s voluntary disclosure protocol. We negotiated the related settlement agreement, as well as an innovative corporate integrity agreement. As a result, we avoided lengthy litigation that could have led to the client being barred from participation in the Medicare program.
  • Represented an individual who was the target of a federal grand jury investigation. The matter involved allegations that he and his company paid illegal kickbacks to physicians to encourage the purchase of kidney dialysis supplies. We successfully prevented charges from being brought against him.
  • Represented physician groups under investigation as part of the Office of Inspector General’s national Physicians at Teaching Hospitals (“PATH”) audit initiative. 
  • Drafted the compliance policies of a physician practice at a major teaching hospital and advised that practice on the establishment of its compliance program.

Insurance Issues

In addition to federal representation, we frequently represent state insurers in rate reviews and other matters. Our clients include: 

  • A national health insurance company, in its negotiations and litigation with a state attorney general and a state insurance commissioner over allegations of unfair and deceptive practices;
  • All of the major health insurance companies in Massachusetts, in litigation challenging a rate cap imposed by the state insurance commissioner;
  • Two of the three largest health insurers in Massachusetts in rate appeals; and
  • A provider of health insurance billing services for college and university health centers.

Physician Practice Issues

Foley Hoag was one of the first firms to recognize the need for faculty practice plans at major teaching hospitals, and we continue to advise practice plans throughout New England. Additionally, our lawyers represent solo and group practices for physicians, dentists and other healthcare professionals.

Our services to physicians include: 

  • Practice formation, expansion, affiliation and/or acquisition and compensation arrangements
  • Physician/hospital strategy development (including IPA, PHO, MSO, affiliated practice and clinic development) 
  • Managed-care positioning and contract negotiation strategy 
  • Medical staff and risk management matters 
  • Other business and long-range financial planning

We also represent healthcare professionals in administrative proceedings involving state licensing boards and professional staff issues. Our experience includes boards that oversee physicians, dentists, optometrists, ophthalmologists, psychologists, pharmacists, social workers and veterinarians.

General Corporate/Organizational/Restructuring

We serve numerous non-profit clients, acting as their general counsel. We also have substantial experience advising clients regarding the organizational requirements and restructuring opportunities presented by state and federal laws, including the Massachusetts Attorney General’s Division of Public Charities and the federal laws governing tax-exempt organizations.

One of our lawyers served on the committee that drafted the enacted amendments to chapter 180 of the Massachusetts General Laws. We also provided advice to a major area hospital concerning its reorganization into a holding company structure. Our work included monitoring activity in congressional committees and the Internal Revenue Services’ position on restructured hospital organizations. And we helped with organizing related support organizations and a cooperative hospital service organization.

Health Information Privacy and Security

One of our lawyers was involved in drafting the Health Insurance Portability and Accountability Act of 1996. Since then, we have been involved in the HIPAA privacy compliance efforts of a variety of healthcare providers and other HIPAA “covered entities.” We have also worked with companies not directly covered by HIPAA. These clients were seeking an understanding of their obligations as HIPAA business associates and the application of HIPAA to their employee health plans.