For each of the industries identified above, our lawyers advise clients in the following substantive areas of Health Care practice. We have built our practice in partnership with other recognized areas of strength at K&L Gates, including our Intellectual Property, FDA, Life Sciences, Tax-Exempt Organizations, Corporate and Debt Finance, Benefits and Executive Compensation and e-Discovery Analysis and Technology (e-DAT) practice groups. With assistance from our Public Policy and Law practice group, we help clients identify new business opportunities and potential resources available through the federal regulatory and funding process. Our association with the firm’s Public Policy and Law practice also enables our lawyers to stay ahead of the evolution of the matrix of laws affecting the health care sector so that we may continue to advise our clients in areas of their greatest need, as well as those most in demand.
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 group 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.
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, incentives or rewards programs for patients, 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, for activities outside of those areas.
Corporate Governance and Compliance
Along with lawyers in the firm’s Corporate and Tax-Exempt Organizations/Nonprofit Institutions practice groups, 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 non-profits so its influence permeates the private sector and the non-profit 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 group has deep experience in designing, implementing, and maintaining corporate compliance plans for health care providers. Our lawyers have designed and implemented 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.
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 laws, 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.
e-Discovery and Technology
Our lawyers understand the myriad of retention laws and regulations, such as Sarbanes-Oxley, that apply to both profit and nonprofit health care organizations. In conjunction with our e-Discovery Analysis and Technology (e-DAT) the Health Care lawyers assist these organizations in developing and implementing policies and procedures regarding the storage, preservation and production of electronically stored information ("ESI"), including, for example, email, voice mail, instant messages, back-up tapes, and similar information. Our lawyers review current document retention practices and pinpoint weaknesses where the potential destruction of records could expose the organizations to significant legal and financial liability. We help to refine policies and discuss future steps to further reduce exposure, including developing litigation hold procedures and notices; providing training programs pertaining to email usage, document retention and litigation response; proposing automated protections; advising on agreements with e-discovery and record management companies; and similar activities.
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, pharmaceutical companies, pharmacies and pharmacists, behavioral health care providers, health systems, management companies and physicians and health care plans charged with or investigated for claims of fraud or abuse. Together with lawyers in our White Collar Crime/Criminal Defense practice group, 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 voluntary disclosure to government agencies and government contractors.
Health Care Benefits Strategies and Innovations
From prescription drug discount cards and programs, to convenient care clinics, to urgent care emergency room alternatives, to managing chronic disease, to establishing global opportunities to receive various types of health care, our Health Care lawyers assist sponsors of self-funded employee welfare plans, other group membership organizations, and providers in their efforts to develop novel approaches for managing health care costs and offering benefit programs to meet new needs and requirements. Working in partnership with our colleagues in the firm’s Benefits and Executive Compensation practice group, we help clients identify and comply with applicable legal and regulatory requirements including ERISA; discount card, third party administrator, and benefit program licensing and registration; consumer protection obligations; and privacy and security standards. We also assist clients in structuring arrangements to avoid violations of federal and state laws such as prohibitions on physician self-referrals, kickbacks and rebate arrangements, patient inducements, state insurance regulations, and the corporate practice of medicine doctrine.
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, 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 or 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.
Health Plan Licensing and Operations
Our health care lawyers have navigated the various federal and state laws and regulations governing licensure and approvals for the acceptance of financial risk for health care services, including requirements under Medicare, Medicaid, and private managed care plans. Our clients include health maintenance organizations, health care service contractors, preferred provider organizations, point-of-service products and integrated delivery systems. Our Health Care team maintains an ongoing dialog with the appropriate regulators before, during, and after licensing to ensure that the health plans benefit from positive working relationships with their regulators. We also work closely with our health plan clients on all aspects of operations, including contract negotiations, compliance, policies and procedures, and reporting mechanisms.
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 group 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 group, 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 and Certificate of Need
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.
Our lawyers also have a proficiency in the "corporate practice of medicine prohibition" doctrine.
Mergers and Acquisitions, Joint Ventures and Strategic Alliances
Our Health Care lawyers and Corporate, M&A and Securities 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 groups, 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. Lawyers in our Bankruptcy/Insolvency practice group 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.
Prescription Drug Dispensing and Reimbursement
Our Health Care lawyers address all facets of the purchasing and 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 complying with requirements of the Medicare Part D program, including matters related to obtaining employer subsidies, member communications and oversight of downstream entities.
Research and Clinical Trials
Manufacturers of medical products (drugs, biologics, medical devices, probiotics and dietary supplements), academic medical centers, research hospitals, for-profit and nonprofit research organizations, institutional review boards (IRBs) and contract research organizations regularly engage lawyers in our Health Care practice to advise them on all aspects of federal and state regulation of pre-clinical and clinical research. Along with lawyers in our Food, Drugs, Medical Devices and Cosmetics practice group, we help these clients comply with FDA and HHS regulations governing use of human subjects and IRBs; creation and use of research tissue repositories and databases; use, donation, importation or exportation of human tissue or cells for research; stem cell research; financial conflicts of interest; and research misconduct. We also help clients obtain INDs and IDEs, including treatment INDs/IDEs; design and implement Phase IV clinical trials of off-label uses; and structure financial management of clinical trials to comply with the federal Anti-kickback Statute, False Claims Act and HIPAA. Our lawyers' representation of clients in this area is enhanced by their research backgrounds and experience as members of university IRBs.
Whether through due diligence investigations for acquisitions or public financing, or by drafting and negotiating clinical trial agreements and budgets, cooperative research and development agreements, Material Transfer Agreements, HIPAA data use agreements and business associate agreements, we assist our clients in moving their research forward. In collaboration with our colleagues in our IP Litigation, Government Contracts and Procurement Policy and Life Sciences practices, we advise clients on all stages of government contracting, including preparation of RFPs, compliance with Federal Acquisition Regulations (FAR) and drafting of subcontracts for pre-clinical and clinical research; NIH grants, SBIR and STTR grants, and genetic privacy issues. We also represent clients in accessing procurements under relevant federal programs, including BioShield legislation.
Rural and Critical Access Hospital Issues
We assist rural hospitals with the determination of whether to become Critical Access Hospitals (CAH) under the Medicare Rural Hospital Flexibility Program and help them comply with the various legal requirements necessary to achieve CAH status. Once a client hospital has obtained its CAH designation, we assist it in understanding and complying with Medicare’s cost-based reimbursement methodology requirements unique to CAHs. In addition, our Health Care lawyers’ involvement with this program since its inception has made them well-practiced at counseling clients on the implications of their CAH status. We advise CAHs on the distinctive legal and regulatory issues they face, as well as issues common to all hospitals, such as HIPAA compliance, Stark compliance, defense against accusations of fraud and abuse, OIG self-disclosure, corporate governance, and licensing and credentialing issues.