Health care is one of the largest and most heavily regulated industries in the United States and touches on every life stage and condition. All sectors of health care activity are subject to complex and ever-changing laws. The Health Care team at K&L Gates tackles the full array of the challenges our clients encounter.
The K&L Gates Health Care practice was listed in Modern Healthcare as one of the 20 largest dedicated health care practices in the United States in August 2011. Our health care lawyers assist start-up enterprises, well-established community and regional health care providers, and national health care businesses. In addition, our Health Care lawyers advise these clients on state and federal compliance issues affecting operations, expansions, and reorganizations. For clients who find themselves subject to government or payor audits or investigations, we counsel clients through those audits and defend against government and payor enforcement actions. As the federal and state agencies impose new laws, regulations, and policies on our clients, we recommend actions to adapt to the changing environment. Our lawyers help clients structure complex business deals involving joint ventures, mergers, acquisitions, spin-offs, and dissolutions.
Because each sector of the health care industry has its own unique rules and standards for operation, we believe industry knowledge is an essential tool in our representation. We pride ourselves on delivering strategic, comprehensive, and practical advice grounded in a thorough understanding of our clients' endeavors and goals.
Anti-Kickback, Anti-Inducement, and Anti-Referral Prohibitions Health care providers and related suppliers are subject to federal and state anti-referral laws unique to the health care industry, which affect numerous transactions and carry stiff civil or criminal penalties if violated. The firm’s lawyers assist in drafting leases, purchase and sale agreements, management services agreements, joint venture documents, joint purchasing agreements, and supply agreements to maintain compliance with these laws. In addition, our lawyers advise clients on proposed activity that implicates these rules, such as physician recruitment and compensation, group practice profit-sharing arrangements, and relationships between hospitals and physicians. Our lawyers advise on the structuring of transactions to meet safe harbors and Stark exceptions and help clients obtain regulatory approvals, where appropriate.
HIPAA, Privacy, and Security The Health Insurance Portability and Accountability Act (HIPAA) restricts the way entities such as health plans, health care clearinghouses, and health care providers may use or disclose individually identifiable health information. Our Health Care practice routinely counsels all types of clients who are business partners of, or who are themselves, covered entities regarding HIPAA’s requirements in developing and implementing the protocols, policies, procedures, safeguards, and agreements required to protect health information, regardless of whether it is in electronic or other forms. We also help our clients inform individuals about their rights regarding their health information by developing documentation of privacy practices that meets regulatory standards. We assist clients in their efforts to respect and address individual rights in the event of a privacy or security breach, a complaint by an individual, or an investigation by the Office of Civil Rights, Office of the Inspector General, or other enforcement agency. Our approach to helping clients protect the privacy and security of health information is comprehensive and includes advice regarding protections under state laws for highly sensitive information such as mental health, substance abuse, reproductive health, and genetic testing results. In conjunction with our Privacy, Data Protection, and Information Management practice, we counsel clients about other applicable federal and state laws relating to security breach notification, secure transmission and disposal standards, and other privacy requirements.
Licensing, Certificate of Need, and Provider Enrollment Our lawyers assist institutional and individual clients in the process of obtaining state licenses and Medicare and Medicaid certification. We advise clients on the impact of transactions on existing licensure and assist in obtaining appropriate government approvals related to those transactions. We also help clients gain approvals for expansions and new services, either through licensure or certificate of need, depending on applicable state law. We have advised institutional and individual clients with potentially difficult histories through the process of disclosure and licensure application. Our lawyers have experience in requesting and obtaining waivers from regulatory requirements. In addition, we assist with internal investigation of sentinel events and incident reporting requirements. We handle administrative appeals from adverse licensure, certification or certificate of need actions, and all related judicial appeals.
Given the increasingly complex process and scrutiny being placed by Medicare Administrative Contractors and Medicaid state agencies on provider enrollment issues, our health care lawyers, in-house consulting professionals, and paralegals assist with the completion and submission of CMS Form 855s and NPIs.
Our lawyers also have extensive experience on the “corporate practice of medicine prohibition” doctrine in a large number of jurisdictions and frequently advise clients on acceptable models for compliance or in negotiations with professional licensing boards.
Prescription Drug Dispensing and Reimbursement Our health care lawyers address all facets of the purchasing of, dispensing of, and payment for prescription drugs and medical devices. We provide many of the same services to retail and specialty pharmacies that we provide to other health care providers. In addition, we help retail, specialty, and mail order pharmacies with licensure and DEA certification, as well as such operational issues as provider network contracting with prescription benefits managers (PBMs) and Medicare Prescription Drug Plans, developing policies and procedures to ensure compliance with Medicare Part D regulations, establishing a compliant electronic prescription system, complying with state drug substitution and mail order pharmacy requirements, and responding to inquiries, audits, and investigations by licensing authorities. We also help eligible pharmacy clients acquire drugs at reduced prices through participation in group purchasing organizations, the federal 340B Drug Pricing Program, and Federal Supply Schedule purchasing.
We assist our health plan clients with contracting and audits of PBMs, including negotiating and evaluating performance under rebate agreements and other cost-sharing arrangements with repricing companies to support disease management programs in compliance with state and federal laws. Our health plan clients also turn to us for help in complying with requirements of the Medicare Part D program, including matters related to obtaining employer subsidies, member communications, and oversight of downstream entities.
Corporate Governance and Compliance Along with lawyers in the firm’s Corporate and Tax-Exempt Organizations/Nonprofit Institutions practices, our health care lawyers advise clients on both existing laws and recent developments in the area of corporate compliance. While many of the Sarbanes-Oxley requirements do not apply to a number of our health care clients, certain provisions apply to nonprofits, so its influence permeates the private sector and the nonprofit world. Our lawyers regularly advise boards of directors on how best to comply with the myriad of changing and often complex rules and government guidance documents. In addition, the firm's lawyers counsel clients on potential penalties relating to corporate activities and methods to reduce corporate and board member risk.
Maintaining an effective corporate compliance plan is a must for today’s health care providers. To that end, the firm’s Health Care practice has deep experience in designing, implementing, and maintaining corporate compliance plans for health care providers. Our lawyers have developed compliance plans for hospitals, long-term care facilities, pharmaceutical and clinical laboratory companies, physician practices, community mental health centers, and various other health care providers. Our lawyers on a daily basis assist internal auditors and compliance officers on investigations, hotline calls, and billing and refund questions.
With white collar criminal lawyer support as needed, our health care lawyers routinely handle internal review, responses to governmental inquiries, and other matters creating potential false claims exposure.
Mergers and Acquisitions, Joint Ventures, and Strategic Alliances Our health care lawyers and corporate lawyers have formed, developed, reorganized, and divested all types of for-profit and not-for-profit health care entities, from small health care providers to large, multi-state hospital systems. Along with lawyers from the firm’s Tax and Tax-Exempt Organizations/Nonprofit Institutions practices, we counsel health care organizations as they consider, pursue, and implement strategic initiatives, including acquisitions, affiliations, program and service line divestitures and closures, and joint ventures with other providers, physicians, and insurers. We assist clients with structuring, negotiating, and documenting the terms of arrangements and collaborations that help them expand their businesses. Our health care lawyers have particular experience in organizing and supervising the diligence review in large, multi-jurisdictional health care transactions. Lawyers in our bankruptcy practice also help providers in financial distress to reorganize, divest, close, negotiate work-out arrangements with creditors and others, and navigate bankruptcy.
Nonprofits and Tax Exemption Working collaboratively with colleagues in the firm’s Tax-Exempt Organizations/Nonprofit Institutions practice, we regularly assist institutional providers, physician practices, health plans, industry associations, foundations, and other clients that are nonprofit entities and tax-exempt organizations in navigating the often complex requirements of the tax code and applicable health care laws. Corporate matters range from forming a new entity and obtaining tax-exemption; to mergers and acquisitions, joint ventures, and strategic affiliations with both nonprofit and for-profit entities; to the creation of organizational and transactional structures to achieve complex fundraising and operational goals; to converting to for-profit status. Such matters include fundraising, applicable public support tests, permissible lobbying activities, avoiding excess benefit transactions, use of bond-financed facilities, political activities, investment of endowment funds, and other matters unique to exempt organizations. In addition, we help clients adopt and operate under best practices of nonprofit corporate governance and operations, including whistleblower and conflict of interest policies, committee charters and board oversight, and compensation for professionals, executives and directors, and other personnel.
Credentialing and Privileges Our health care lawyers are extensively involved in physician recruitment, retention, and credentialing matters. We represent hospitals and physicians acting on behalf of hospitals in these matters (e.g., department chairpersons and committee members), as well as physician practice groups and other providers with delegated credentialing from health plans. The firm’s lawyers counsel hospitals, medical staff members, and physician practice group administrators in credentialing competency and behavioral matters, including disciplinary sanctions and reporting obligations to state licensing authorities or the national practitioner data bank. Our lawyers assist in drafting medical staff by-laws and assuring compliance with state licensing, antitrust and anti-referral laws. We advise hospitals, medical staffs, physician groups, and other providers on exclusive contracts and formulate medical staff development plans. Our lawyers assist in the creation and implementation of medical staff development and applicant priority plans as well as in the guidance and defense of professional peer review and other medical staff actions.
Health Information Technology and Health Care E-Commerce Our health care lawyers assist clients with the development and implementation of information technology to improve clinical outcomes, to reduce health care costs, and to enhance health care operations. Our health care and intellectual property lawyers have experience with the unique combination of privacy, security, intellectual property, and health regulatory issues involved in the development, licensing, management, and deployment of electronic health or medical records (EHRs or EMRs) and electronic prescription (ePrescribing) systems, as well as the legal and regulatory challenges to making those records available to physicians on a regional basis. In these matters, we help clients navigate requirements for complying with federal and state privacy and security standards, prohibitions on payments for referrals, documentation requirements, and health care transactions requirements, as well as obtaining administrative approvals or certifications.
We provide proactive guidance to enable clients developing new proprietary technology and applications for existing technology to build legal compliance into their technology or service offering, where possible. The firm’s lawyers provide counseling and transactional representation in matters involving clinical decision support tools (including artificial intelligence applications), clinical data repositories and registries, telemedicine and teleradiology applications, Internet pharmacy and other health care e-commerce solutions, electronic health care claims processing and payment systems, physician practice management systems, consumer and patient health information portals, and health data mining applications.
Administrative Litigation and Challenges to Government Action The firm represents health care trade associations and their individual members in connection with rulemaking and adjudications before state and federal administrative agencies and in connection with challenges to agency actions brought in state and federal courts. In conjunction with our lawyers skilled in administrative litigation and procedure, our Health Care practice assists clients interested in ensuring that agencies engaged in rulemaking and adjudications compile complete and balanced administrative records to assure protection of our clients’ interests in the event of later challenge. We also represent those clients, and their respective trade associations, when it becomes necessary to seek judicial review of agency actions such as rules, formal adjudications, licenses, permits, and other informal adjudications. Our administrative litigation practice extends to include significant experience in litigating certificate of need cases, as well as penalty, exclusion, de-certification, and other similar administrative or agency enforcement actions. By combining substantive knowledge with decades of experience appearing before and litigating against state and federal agencies, we provide value to our clients in the form of novel approaches to administrative law challenges.
Fraud and Abuse Investigations and Defense The firm represents numerous providers confronting investigations arising under the Medicare and Medicaid programs. Among these clients are hospitals and health systems, pharmaceutical companies, pharmacies and pharmacists, behavioral health care providers, management companies, and physicians charged with or investigated for claims of fraud or abuse. Together with lawyers in our Government Enforcement practice, we defend claims initiated by the Department of Health & Human Services, United States Attorneys’ Offices, and the Medicaid Fraud Control Units. Our Health Care lawyers also assist clients with their responses to government audits conducted by state or federal health program authorities. In addition to defense of a client through an investigation, trial, and appeal, we assist in settlement of matters, development of corporate integrity agreements, and implementation of compliance programs. In the ongoing operation of these compliance programs, we advise clients on the receipt of complaints and conduct of internal investigations. Our Health Care lawyers also assist clients with questions regarding self-disclosure to government agencies and government contractors.
Licensing, Certificate of Need (CON), and Provider Enrollment Our lawyers assist institutional and individual clients in the process of obtaining state licenses and Medicare and Medicaid certification. We advise clients on the impact of transactions on existing licensure and assist in obtaining appropriate government approvals related to those transactions. We also help clients gain approvals for expansions and new services, either through licensure or certificate of need, depending on applicable state law. We have advised institutional and individual clients with potentially difficult histories through the process of disclosure and licensure application. Our lawyers have experience in requesting and obtaining waivers from regulatory requirements. In addition, we assist with internal investigation of sentinel events and incident reporting requirements. We handle administrative appeals from adverse licensure, certification or certificate of need actions, and all related judicial appeals.