Providing answers to complex problems

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 government relations, litigation, corporate transactions, tax, antitrust, real estate, and environmental law. For over two decades, we have served as general or special counsel to healthcare providers, payors, pharmaceutical and medical device manufacturers, service providers and technology developers.

Regulatory Advice

Foley Hoag represents a number of leading pharmaceutical, biotechnology and medical device companies regarding government strategies for regulatory, legislative and administrative matters.

We understand that regulatory and related legislative matters are of critical importance for pharmaceutical, medical device and biotech companies. These policies impact our clients’ ability to market their products and to receive adequate reimbursement for their products, especially through public and private insurance coverage. While the federal government presents regulatory hurdles for business planning, it also plays a critical role in creating new markets and products. Our lawyers work directly with congressional staff and federal regulatory agencies, including the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS), on a variety of these matters. This gives us the experience and knowledge to provide the best possible counsel to our clients.

Medicare Coverage/Reimbursement Issues

A federal appeals court once described Medicare regulations as “among the most completely impenetrable texts within human experience.” Healthcare companies must navigate Medicare, as well as a myriad of other constantly changing laws and regulations. As federal programs, such as Medicare and Medicaid, pay more health-related expenditures, receiving full allowed coverage has become increasingly crucial to our clients. This is not only important economically, but because these programs also provide the primary model for private-sector reimbursement.

Foley Hoag lawyers have extensive experience representing clients in matters before CMS; and we regularly participate in legislative, regulatory and administrative matters affecting CMS’s programs and policies. We often assist our clients in obtaining coverage and adequate payment for healthcare services, biologics, pharmaceuticals and medical devices.

Our lawyers are also particularly adept at working with our clients in developing novel products or therapies. We know our clients need effective strategies for assuring adequate reimbursement from public and private third-party payors. Our strategies often include seeking coding and payment changes for physician and other healthcare services related to new technologies. Lawyers at Foley Hoag also work with our clients to obtain coverage for new biologics and medical devices, and to ensure that Medicare sets appropriate reimbursement rates for hospital inpatient and outpatient prospective payment systems.

Healthcare Compliance and Investigations

Foley Hoag assists healthcare clients in compliance efforts and defending against civil and criminal claims of fraud. On these matters, our healthcare lawyers regularly work in combination with our business crimes lawyers or other relevant specific practices. We 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 our first priority is to work with our clients to create and implement effective compliance programs. This helps them reduce their risk of criminal investigations or allegations. Federal and state investigative, prosecutorial and sentencing policies increasingly emphasize the implementation of such compliance programs.

We 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. We’ve listed some examples of our experience below:

  • On behalf of our 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 our 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.

Legislative Representation

Our lawyers have substantial experience working with the United States Congress.  Many worked in Congress and as congressional staff members. As a group, our lawyers have been involved in drafting many important pieces of health legislation over the past decade. These include:

  •  1997 Food and Drug Administration Modernization Act
  • Orphan Drug Act
  • Health Insurance Portability and Accountability Act of 1996 and other comprehensive healthcare reform legislation
  • Legislation involving specific changes to Medicare and Medicaid law  

We’ve also provided legal and legislative counsel to our individual and corporate clients regarding a wide range of legislative matters.  On our clients’ behalves, we have prepared draft legislation and analyzed legislative proposals, interacted with congressional members and staff, prepared congressional testimony and advised clients in connection with committee and subcommittee hearings.

Foley Hoag’s lawyers also assist clients in presenting their concerns to members of Congress.  For example, our lawyers have recently assisted our clients in advocating for increased funding for biomedical research, human subject protection legislation, and for reasonable protections of the confidentiality of healthcare information.  Some of the specific legislation in which we have been involved includes:

  • Represented clients on issues related to drug pricing and reform of the Average Wholesale Price (AWP) for drugs.
  • In connection with the reauthorization of the Prescription Drug User Fee Act and the Public, Health, Security and Bioterrorism Preparedness and Response Act, we represented several leading pharmaceutical and biotechnology companies and industry trade associations.
  • Represented companies under the Orphan Drug Act. This act is credited with giving rise to the biotech industry through its provision of seven years of marketing exclusivity to the companies that develop drugs or biologics for patients with rare diseases.
  • Involved in the reauthorization of pediatric drug exclusivity provisions.  These provisions require drug companies to perform pediatric testing and labeling on new products, but they also grant manufacturers a six-month patent extension for pediatric labeling.
  • Represented leading pharmaceutical and biotech companies in connection with the Medicare Prescription Drug, Improvement and Modernization Act of 2003. We now advise companies on implementation of the act.
  • Involved in legislation relating to competitive bidding for certain durable medical equipment.
  • Involved in issues related to “Hatch-Waxman” patent term issues.

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 represents 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 Lawyer 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.

Links

US Dept. of Heath and Human Services - Office for Civil Rights - HIPAA
http://www.hhs.gov/ocr/hipaa/

Center for Medicare & Medicaid Services
http://www.cms.hhs.gov/

U.S. Food and Drug Administration
http://www.fda.gov/

Massachusetts Board of Registration in Medicine
http://www.massmedboard.org/