We represent institutional, group practice and individual providers, life sciences companies, laboratories, health IT companies, clinical research organizations (CRO), and other health care entities regionally and nationally and handle the regulatory, transactional, operational, administrative and courtroom hurdles faced by these health care organizations. Our attorneys have experience in all aspects of health care law, including regulatory compliance, state and federal agency audits and investigations, pharmacy law, and complex health care litigation matters, ranging from fraud and abuse allegations to Medicare/Medicaid audits and appeals to health care licensure and certificate of need matters. Whatever the client needs, our health care practice group provides knowledgeable and experienced attorneys from coast-to-coast.
We have the experience in the ever-changing health care regulatory legal landscape. Our attorneys guide clients in their compliance initiatives, including developing policies and procedures with clients to meet their stated compliance needs, including compliance with federal and state health care program laws, such as:
- HIPAA (HITECH, Omnibus Rule, privacy and security and breach notification);
- Federal and state fraud and abuse laws, including anti-kickback laws, false claims acts, and Stark laws;
- Antitrust law;
- Patient Protection and Affordable Care Act;
- Physician Payment Sunshine Law and related state and local transparency laws;
- Accountable Care Organization regulations;
- Deficit Reduction Act;
- Medicare secondary payer rules;
- Provider payment regulations;
- Conditions of participation, payment and coverage;
- Recovery Audit Contractor (RAC) program rules;
- Dual eligibility rules;
- Physician extender laws;
- Telehealth/telemedicine/mHealth laws;
- MACRA/QPP Final Rule/APMs and MIPS;
- FDA laws and regulations; and
- Prescription drug modernization and marketing laws.
We provide compliance guidance in the above areas and assist clients with internal, external and governmental investigations, audits, appeals, and the defense of civil and criminal enforcement actions and lawsuits, including the defense of claims brought under the federal False Claims Act (FCA), Civil Monetary Penalties Law, and HIPAA criminal provisions.
Our attorneys handle health care corporate and transactional matters at the national, regional and local levels. We assist health care and life sciences clients in corporate matters, including joint ventures, mergers and acquisitions, contracts and agreements, financing, regulatory matters, due diligence compliance reviews, board structure, and corporate governance.
We steer clients through contract and agreement matters, from negotiating initial terms to drafting documents to executing the terms and ensuring each party meets its responsibilities. We handle a variety of health care contracting matters for our clients, including hospital-physician joint ventures, employment, lease, professional services, locum tenens, pharmacy, management services, consulting, co-management, insurance provider and medical director agreements.
Our attorneys recognize each contract and agreement is unique, and there is no universal approach. That’s why we work closely with each client to identify its specific goals and tolerances, enabling the client’s circumstances to establish the framework for the process. Our attorneys have the experience and technical knowledge to guide our clients through even the most difficult mergers and acquisitions and health care transactions.
Our attorneys who conduct internal investigations understand the pressures placed on providers and entities operating in the highly-regulated health care industry. With increasing state and federal regulatory requirements, there are more ways for a provider to find itself and its employees under close scrutiny. There are incentives for whistleblowers – found both inside and outside the provider – to bring any alleged wrongdoing to the government’s attention.
We help clients work proactively by conducting thorough internal investigations of any potential wrongdoing or non-compliance. Through fact-gathering, document review and questioning of employees and other witnesses, our attorneys are able to find the information the client needs to plan an effective and appropriate response. We also assess whether any individual employees might need separate representation during the investigation.
At the conclusion of each investigation, we prepare a detailed report that presents our findings and makes recommendations to assist our clients in minimizing and mitigating its risks, including the risk of committing health care fraud. When needed, we work with our clients, to take appropriate corrective action, including making voluntary self-disclosures and returning overpayments, creating or updating compliance and governance plans, and responding to government inquiries.
Provider Licensure, Credentialing & Administrative Proceedings
We represent physicians, nurses, and other physician extenders and health care professionals in licensure, credentialing and medical staff matters, including handling board and other administrative and disciplinary hearings and investigations. We have team members who previously worked as attorneys for the State Medical Board of Ohio handling these matters. We also have attorneys with experience handling Medicare/Medicaid audits, ALJ hearings and administrative appeals, as well as Certificate of Need matters.
Our health care attorneys provide comprehensive representation in FCA, including:
- Counseling and/or compliance audits to prevent FCA litigation;
- Advising when and how to make voluntary disclosures;
- Conducting internal investigations in response to internal whistleblower complaints or other compliance concerns;
- Responding to subpoenas or other inquiries from federal and state agencies;
- Persuading the Department of Justice (DOJ) not to intervene in qui tam actions;
- Crafting successful motions to dismiss FCA complaints;
- Litigating intervened and non-intervened FCA cases through discovery, summary judgment, trial and appeals;
- Negotiating global settlements with the DOJ, state attorneys general, Medicaid Fraud Control Units, counsel for federal and state agencies, and relators’ counsel;
- Negotiating with agency counsel to prevent suspension, exclusion or debarment; and
- White collar litigation, including former U.S. attorneys.
We have conducted investigations from California to Connecticut, defended FCA litigation in jurisdictions across the country and in the Virgin Islands, obtained dismissal of FCA cases, and prevailed in appeals in FCA cases in U.S. Circuit courts and the U.S. Supreme Court. Below are a few representative examples of our experience and capabilities:
- We defended an academic medical center in an FCA qui tam lawsuit involving allegations related to the cost reporting of GME experience. The government declined intervention.
- We defended a national physician practice in an FCA qui tam action involving emergency department billing practices. The government declined intervention.
- We defended an academic medical center physician practice in an FCA qui tam action alleging improper referral arrangements. The matter resolved for nuisance value with no CIA or other penalty.
- We defended an academic medical center in an FCA qui tam action relating to alleged improper billing practices. The client was operating under a CIA at the time of the representation. The matter was resolved favorably for our client after extensive eDiscovery with no extension of the length of the CIA and no press release issued by the federal government.
Pharmacy & FDA Guidance
Our group includes attorneys who are licensed pharmacists and former medical researchers/scientists, who combine their technical and practical experience with their legal knowledge to advise clients in the pharmacy, pharmaceutical and medical device industries. Our attorneys guide clients’ efforts to comply with pharmacy board, DEA and CMS regulations, 340B program requirements, USP 797 and FDA sterile compounding requirements, and Joint Commission and HFAP accreditation standards. They have a strong knowledge of specialty pharmacy, managed care, and pharmacy benefits management and long-term care pharmacy practice.
We also provide FDA regulatory advice to medical device, drug and cosmetic manufacturers, and mobile health application developers. We assist clients ranging from individual entrepreneurs to Global 100 companies. Our FDA experience includes assisting clients in classifying products, navigating the 510-K notification process, advising clients on compliance with CGMPs, labeling and advertising regulations.
HIPAA & Cybersecurity
Modern health care organizations face many cyber threats. One of the most significant threats in recent years is ransomware -- a form of cyber-attack that encrypts (or locks) data until the owner pays a ransom to the attackers. Once encrypted, that data – whether it is emails, accounting information, or patient treatment information – is unavailable to the organization, often severely disrupting operations. The prevalence of these attacks in the health care sector shows that health care organizations of all sizes must be vigilant. Health care organizations should take measures to prevent cyber-attacks of all varieties, including ransomware. In this ever-changing health care data security and cyber landscape, we guide covered entity and business associate clients in all aspects of HIPAA compliance by:
- Help create effective governance programs;
- Assist with implementation of comprehensive compliance policies and procedures;
- Provide analysis and investigation of alleged security breaches;
- Conduct risk assessments and training programs; and
- Draft customized documents tailored to our clients’ business needs and technologies.
We provide guidance to health care entities regarding HIPAA privacy rule violations and breaches. We have experience with OCR in resolving breach investigations favorably for clients. We handle breach notification risk assessments, including addressing state data breach laws and requirements, many of which have more stringent notification requirements than HIPAA that must be taken into consideration. We represent several national health care providers and conduct HIPAA breach investigations for them across the country, engaging computer forensic experts, and overseeing the conduct of their analyses, when required. We also represent a number of large health care vendors with their HIPAA compliance matters. We have experience drafting and reviewing BAAs for health care providers, as well as business associates and vendors.
We also provide counsel to a number of health plan third-party administrators, large employers who sponsor group health plans, Internet service providers, cloud providers, and other entities affected by and potentially required to comply with the HIPAA Privacy and Security Rules.
Telehealth, Telemedicine & mHealth
As technology continues to be a driver in health care, our attorneys have developed mastery in telehealth/telemedicine and mobile health technologies. Our attorneys have knowledge of the federal and state regulations that impact the implementation of telehealth and telemedicine by their clients. In particular, we advise clients on reimbursement, licensing, credentialing, prescribing, compliance, and privacy and security all within the context of telemedicine. We understand federal and state law implications and are able to assist clients in developing cost-effective and compliant telehealth and telemedicine programs.
We defend a variety of health care clients, including hospitals, ambulatory centers, physicians, nurses, chiropractors, optometrists, nursing homes and allied health professionals against malpractice claims and lawsuits. Recognizing medical malpractice claims can involve complex medical issues, procedures and terms, our attorneys are comfortable with these specialized subjects and often consult and retain top medical specialists to testify on behalf of our clients. We represent clients in cases such as failure to diagnose, misdiagnosis, medication errors, surgical procedures, postoperative complications, and labor and delivery. Many cases can be most effectively and economically resolved out of court, but when it best serves our client’s interests, our attorneys are ready and able to take a case to the jury.
We represent issuers, borrowers, investment banks and commercial leaders on transactions, including financings for innovative health care programs, such as community health centers, facilities for programs of all-inclusive care for the elderly and critical care access hospitals.
Labor & Employment
Our attorneys serve institutional and individual health care providers with the transactional and operational hurdles faced by all organizations. These include labor, employment, benefits, immigration and management concerns.