Healthcare

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Overview

Sheppard Mullin’s healthcare practice is the fastest growing – and one of the largest – multi-sector healthcare law practices in the U.S. With 230+ lawyers, we have been named multiple times by Law360 as U.S. Health Law Practice Group of the Year.

We partner closely with our clients to provide strategic business solutions tailored to their business goals, challenges, and legal service needs. We offer pragmatic, creative solutions while drawing on holistic industry viewpoints and legal prowess on transactional and regulatory issues, and litigation-readiness. We offer end-to-end capabilities to support our healthcare clients, and are able to bring the proper resources to bear to help them meet their legal and business objectives.

Clients

Our Healthcare Team serves a wide array of clients across and tangential to the healthcare industry, including:

Health Plans, Insurance Companies and Risk-Bearing Organizations
Hospital Systems – Academic, Nonprofit, Religious and For-Profit
Physicians and Dental Practices
IPA, CIN and ACO Networks
Digital Health, Telehealth, Healthcare Information Technology, Artificial Intelligence
Healthcare Facilities, ASCs, Urgent Care and Other Clinics
Private Equity and Hedge Funds and Their Portfolio Companies
ASCs, Home Health, Hospice, Labs, Imaging and Other Ancillary Services Providers
Post-Acute Care Providers
Healthcare Finance Companies (Banks and Non-Bank Lenders)
International Healthcare Entities and Investors
Retail Pharmacy
Specialty Pharmacy, Pharmacy Benefit Management, Pharmaceutical Manufacturers, Drug Discovery and Clinical Trial Companies
Start-Ups and Early-Stage Healthcare Businesses
Management Services and Revenue Cycle Management Organizations
Veterinary/Animal Health Providers and Investors

Services

Mergers, Acquisitions and Joint Ventures

Named as a Top 10 Healthcare Merger & Acquisition Law Firm by U.S. Healthcare M&A News, Sheppard Mullin has one of the strongest national healthcare transactional practices in the country. We represent the full spectrum of healthcare industry participants in a broad variety of financial, structural and traditional corporate law matters, both large and middle-market, including:

Mergers and acquisitions
Private equity recapitalizations
Joint ventures and strategic alliances
Vertical integration transactions
Corporate restructuring

We are valued for our broad and deep experience in advising healthcare organizations in connection with sophisticated, complex, and innovative transactions. We understand the challenges and opportunities faced by our clients, and offer strategic, actionable solutions that help our clients achieve business objectives, protect and expand their business interests, and promote high quality and cost-effective patient care.

Compliance – Fraud and Abuse

We provide counsel to healthcare clients in virtually all manner of regulatory compliance and enforcement issues. We routinely advise on physician self-referral laws, fraud and abuse laws, corporate practice of medicine and fee-splitting prohibitions, HIPAA privacy, charitable trust law, private inurement, private benefit and excess benefit restrictions, antitrust, licensure, accreditation, Medicare and Medicaid reimbursement, certificate of need/certificate of exemption laws, and medical staff bylaws issues.

We serve as legal counsel to a wide variety of healthcare organizations involved in the delivery and financing of healthcare. We advise clients on a multitude of regulatory issues associated with mergers and acquisitions, joint ventures, physician recruitment, acquisition of physician practices, physician contracts, physician practice management arrangements, governmental investigations and audits, whistleblower suits, Medicare and Medicaid coverage and reimbursement requirements, attorney general investigations, corporate governance/fiduciary duty issues, corporate compliance matters, and medical staff disputes.

Sheppard Mullin provides comprehensive, insightful and cost-effective legal services to healthcare clients. Whether you need sophisticated advice to develop a business model that clears regulatory hurdles, or a seasoned veteran to defend an enforcement action or respond to a regulatory challenge, we can assist you in the following areas:

Develop and implement healthcare regulatory compliance programs (including programs consistent with the OIG’s Model Compliance Program Guidance for Pharmaceutical Manufacturers) designed to identify and mitigate life sciences-related regulatory risks including risks associated with provider relations (including consulting agreements and speaking contracts), pricing, marketing practices (including off-label marketing); Medicare and other governmental program participation conditions and standards; Medicare Part D, and the Sunshine Act.
Conduct internal audits and investigations relating to compliance with a myriad of statutory and regulatory requirements including those related to (i) the federal Antikickback Statute, Stark Laws, and corresponding state and federal laws that impact manufacturer/physician relationships; (ii) the Medicaid Drug Rebate Program; (iii) the 340B Drug Pricing Program; and (iv) FDA rules and regulations.
Develop and conduct legal update and compliance seminars for boards of directors, officers, sales and marketing personnel, and administrative and clinical staff of national and regional diagnostic and therapeutic service providers covering various current compliance issues impacting provider clinical and business operations. Such issues have included fraud and abuse and physician self-referral laws (e.g., Stark) and their application to physician interactions; the HIPAA and HITECH and state-specific confidentiality and security laws; the PhRMA and AdvaMed Codes; the Sunshine Act requirements; and the laws and policies relating to the Medicare reimbursement of healthcare provider and supplier services.
Provide HIPAA advice and compliance representation including the development and implementation of HIPAA compliance plans including the preparation and revision of privacy and security-related policies and procedures and business associate agreements.
Advise clients regarding the development and implementation of FCA and qui tam relator (whistleblower) risk mitigation strategies and programs.
Advise clients on disclosure and reporting obligations and strategies under the various federal and state false claims laws.
We are hospital regulatory and compliance experts. We guide hospitals with governmental healthcare program participation and reimbursement; provider and payor licensing, certification, and accreditation; and daily interactions with the healthcare-related federal governmental agencies (e.g., CMS, FDA, DEA, DHS) and New York state governmental agencies (e.g., Department of Health, Office of Medicaid Inspector General, Office for People with Developmental Disabilities).
Our regulatory compliance attorneys assist clients in evaluating and structuring transactions or relationships to comply with the Stark Law, fraud and abuse laws, anti-kickback and fee splitting laws, Medicare billing compliance and the pertinent tax exemptions.

Commercial Litigation

Our healthcare litigation team protects the interests of our healthcare clients in commercial litigation and civil disputes, internal investigations, and enforcement actions. What sets this team apart is our deep knowledge of the healthcare industry, which allows us to be effective advocates for our clients. Our understanding of the business needs and healthcare regulatory environment shapes all aspects of our dispute management strategy, from possible out-of-court resolution of disputes all the way through trial. Our litigators possess exceptional trial and appellate skills, and regularly litigate in state and federal courts at all levels and venues across the country. Our team consists of over 250 seasoned trial and appellate lawyers that represent clients across the healthcare industry.

In addition to appearing in state and federal courts, we have significant experience appearing before various arbitral forums such as the American Arbitration Association (AAA), Judicial Arbitration and Mediation Services (JAMS), and the International Chamber of Commerce (ICC), representing healthcare entities through evidentiary hearings, state and federal court award confirmations, and enforcements of judgment.

We have successfully brought and defended a broad base of claims and issues, including:

Disputes arising from mergers, acquisitions and dispositions
Federal Trade Commission and state attorney general antitrust enforcement actions
Defense of False Claims Act and fraud and abuse claims
Corporate governance and control
Challenges involving contracts and reimbursement, including administrative appeals
Class actions
Bankruptcy of hospitals as creditors
White collar and healthcare business crimes defense
Employment, including wrongful termination, sexual harassment and class actions
Enforcing restrictive covenants
Fiduciary duty litigation
Managed Care reimbursement and risk fund disputes
Product liability and mass tort claims
Real estate litigation, including planning, zoning and environmental disputes
Telephone Consumer Protection Act violations
Trade secret, patent, and intellectual property disputes
Union representation in litigation, arbitration and contract negotiation
ACA § 1557 discrimination claims

False Claims Act Litigation

Sheppard Mullin’s attorneys are among the nation’s leading specialists with respect to the healthcare False Claims Act cases, including those pertaining to kickbacks, up-coding services, services not rendered, ghost patients, bundling and unbundling, lack of medical necessity, false certification, research grant fraud, improper financial interests and referrals (including the Stark Law), inflating cost reports, inferior quality of care, red-lining, and Medicare Part D fraud and related qui tam whistleblower actions. Our team includes former federal and state prosecutors, former government attorneys, and health law practitioners. We have handled over 100 False Claims Act cases – from early investigation and resolution to complete defense verdicts at trial – the team has a thorough understanding of those factors relevant to a successful False Claims Act case.

Our trial experience enables us to anticipate and shape the course of an investigation, putting our client in the best position to resolve it satisfactorily whether by settlement or trial defense.

We listen to you, our client, to understand your business needs and plans as well as your operational resources and constraints. We then provide clear guidance and practical advice that allows you to manage the investigation or litigation in a manner that fits with rather than disrupts the broader framework of your objectives, priorities, and resources. We have obtained declinations as well as defense verdicts in civil and criminal cases arising from the alleged violations of the complex regulatory schemes our clients must navigate.

Appeals, Disputes and Protests Involving Governmental Agencies

Sheppard Mullin's Healthcare Team offers seasoned expertise in managing appeals, disputes and protests involving governmental agencies. Our formidable track record is rooted in years of direct engagement in these areas of practice, representing a diverse group of healthcare entities with various complexities and contexts. We have a proven history of successfully navigating our clients through the intricate legal landscape, involving numerous federal, state and local health authorities. Our focus is on addressing the unique legal challenges faced by our clients and resolving disputes efficiently and effectively, ensuring compliance with the evolving healthcare regulations. At Sheppard Mullin, we are committed to protecting our clients’ interests and facilitating their continued growth within the dynamic and heavily regulated healthcare environment.

Value-Based and Global Risk Arrangements

Today’s U.S. healthcare market is seeing rapid change, and Sheppard Mullin is leading an unprecedented level of the most innovative transactions addressing the current trends of an accelerated movement to risk-based and value-based reimbursement structures; tremendous growth in the acquisition and launching of Medicare Advantage health plans and their acquisitions; and a national movement towards value-based contracting between payors and providers, with opportunity for greater reimbursement to providers if they create value for payors and members by increasing quality and reducing costs.

We represent most of the leading companies nationally implementing healthcare reform through coordinated care and population health management initiatives. We also regularly represent physician organizations in innovative transactions. No other law firm is doing as many interesting value and risk-based deals as Sheppard Mullin.

HIPAA, Data Privacy, and Cybersecurity

Health Information Privacy

We advise clients on the complex framework of privacy and security laws that regulate health information and impact data assets. We offer practical and sophisticated counsel in this area of growing concern to providers, patients, and health and wellness companies. Our in-depth guidance includes advising on the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act (“HITECH”), 42 CFR Part 2 regulations (“Part 2”), the Genetic Information Nondiscrimination Act (“GINA”), the Biometric Information Privacy Act (“BIPA”), and other state and federal laws impacting health information and sensitive areas, all of which continue to evolve. Specifically, we regularly counsel some of the world’s largest and most respected health systems, health plans, contract research organizations, pharmaceutical companies, and technology companies on:

HIPAA architecture and data flow structuring
HIPAA and state data incident response, including governmental investigations
Red Team review of public asset risks and table top breach assessments
Data privacy compliance program development and review, including policy and procedures and manager and workforce training
Data collaborations, including Data Access and Use Agreements and modernizing Business Associate Agreements
Data as an asset programming and health information technology license agreements
Tracking technology use
Accessing and use of sensitive information
Distinguishing consumer data and health information
Applicability and compliance of state health information laws, such as California’s Confidentiality of Medical Information Act (“CMIA”), Washington’s My Health, My Data Act (“MHMDA”), and laws protecting sensitive health information, such as behavioral and reproductive health, substance abuse, and minor patients’ rights
Legal issues and risk mitigation strategies relating to artificial intelligence (“AI”) and derivative data rights

Data Privacy and Security

Sheppard Mullin’s award-winning data privacy and security team represents some of the largest and most respected companies across the global healthcare industry spectrum. We assist established and start-up innovators in healthcare businesses in assessing their current systems and vulnerabilities and identifying the laws and regulations that apply.

Navigating the web of privacy and security laws and regulations that often do not reconcile is a daunting task requiring experienced, knowledgeable, and practical legal counsel with a thorough understanding of data privacy and security laws and regulations as well as ethical and business considerations. Our healthcare data privacy and security attorneys include a former Deputy General Counsel at the United States Department of Homeland Security, a former attorney and investigator at the U.S. Department of Health and Human Services/Office for Civil Rights, and a lawyer who literally wrote the book on data breach. Our team also includes a former FBI Special Agent and investigations specialists, award-winning privacy class action litigation practitioners, and leading EU-based data protection experts. Many of our team members are CIPP-US and CIPP-EU certified by the IAPP.

We advise clients on how to permissibly extract value from the data they collect, while identifying and addressing regulatory compliance requirements, and ensuring that data is appropriately protected. Our attorneys have experience responding to high-profile data breaches, including state-sponsored attacks, and the regulatory investigations and litigation that often follow such incidents, including class actions. We also provide proactive and strategic counsel to help companies understand emerging developments in this rapidly changing area of law, particularly with cross-border collection and international data transfers including General Protection Data Regulation (“GDPR”) compliance.

What We Do

Counsel clients on managing data as an asset
Establish data access and sharing programs, including prepare patient authorizations and notices
Draft and review terms of use and privacy policies for health applications and websites
Counsel clients on web-tracking risk and mitigation and use of novel technology
Provide management, vendor, and workforce compliance training
Assist and advise clients in HITRUST certification and/or healthcare industry ISACs
Advise on compliance with PCI-DSS, NIST, and other security standards
Assist clients in achieving risk analyses, forensic reviews, and auditing standards
Draft and review contractual arrangements, such as Business Associate Agreements (“BAAs”), Data Access and Use Agreements, Contractor/Vendor Agreements, and Payor Agreements
Draft protective indemnification and contractual clauses related to data protections
Prepare for and defend against governmental audits and investigations and private lawsuits and class actions
Assist in compliance with applicable breach notification laws
Conduct privacy and security diligence related to mergers, acquisitions, divestitures, and other transactions and investments
Counsel on legal issues related to AI and derivative data rights
Advise on the legalities and risks of data transfers, including cross-border transfers
Guide and negotiate cyber liability insurance coverage
Advise on the Children’s Online Privacy Protection Act (“COPPA”)

Healthcare Real Estate and Finance

Sheppard Mullin’s healthcare real estate lawyers have a deep understanding of the complex regulatory issues that arise in healthcare real estate transactions and operations, including the Stark Law, Anti-Kickback Statute, co-location rules, and other federal and state healthcare regulations. Our Healthcare Real Estate Team provides strategic counsel to health systems, providers and investors regarding regulatorily-compliant vehicles, such as joint ventures and other syndications, to monetize assets, maximize returns and provide quality patient care. Our team takes a business-minded, results-oriented approach that delivers market returns on investment, as well as a return on mission. We also counsel on compliance with tax matters, nonprofit corporation and canon law, and other ethical considerations. Sheppard Mullin’s Healthcare Real Estate Team is strong, deep, and comprised of practitioners nationwide.

Services include:

Strategic planning, growth initiatives and value creation
Mergers, acquisitions, dispositions, joint ventures and sale/leaseback transactions
Healthcare facility leasing
Stark law, Anti-Kickback Statute, co-location rules, fraud and abuse, reimbursement and antitrust
Tax structuring and tax-exempt finance
Healthcare finance
Construction, land Use and planning
Title and survey, zoning and environmental review
Operational matters and regulatory support
Regulatory, leasing and other real estate disputes and litigation
Non-profit finance

FDA

Our attorneys represent companies across an array of industries—digital health and medtech, pharmaceutical, biologics, medical devices, dietary supplements, and cosmetics—on matters spanning the total product lifecycle, from concept to commercialization. We bring an innovative approach to resolving complex regulatory issues that complements our client’s cutting-edge technologies and novel products.

Our work begins in the planning and research and development phases and includes counseling on strategies for product positioning, review of novel ingredients and technology, the conduct of clinical trials, and market and patent exclusivity options. As part of the product development and approval phase, we assist clients in the preparation and submission of marketing applications, help facilitate meetings with FDA and other international regulators, and assist in the preparation for pre-approval inspections. We also partner with clients to handle and resolve post-marketing issues, such as product safety issues, including adverse event reporting and recalls, import-export issues, obtaining supplemental approvals, responding to formal and informal agency enforcement actions, and all aspects of marketing, including, labeling, advertising and promotion issues. Our team also handles complicated legal and regulatory aspects of inspections and audits, including representing clients before the FDA and U.S. DOJ, conducting cGMP and QSR audits and data integrity reviews, and assisting clients in responding to agency enforcement actions, including 483s, Warning Letters, and investigations.

Our attorneys also have extensive experience in conducting regulatory compliance due diligence audits of potential acquisition targets and negotiating licensing, supply, and distribution agreements.

Digital Health and Telemedicine

Sheppard Mullin is at the forefront in advising healthcare innovators on matters related to digital health technology, along with their emerging regulatory and legal implications. We leverage our multi-disciplinary team with deep experience in cutting edge digital health technologies, helping our clients bring next gen innovations to market, including, but not limited to, artificial intelligence (AI), telehealth and telemedicine platforms, blockchain, augmented reality (AR), virtual reality (VR), wearables, software and mobile health applications, digital therapeutics, remote patient monitoring, electronic health record platforms, value-based care, and personalized medicine.

Our experience provides us with a unique perspective and understanding of health technology clients to operate, compete, and prosper in the highly competitive healthcare industry. We tackle the entire life cycle of digital health issues across key disciplines such as healthcare regulatory, FDA, cybersecurity and data privacy, health technology, intellectual property, healthcare M&A, and corporate structure strategy. We work with health insurers and third-party payors, healthcare providers and health systems, physician organizations, venture capital and private equity firms, biotechnology companies, medical device manufacturers, software developers and technology platform providers, and telehealth and telemedicine providers.

Artificial Intelligence, Machine Learning, Information Technology

Sheppard Mullin has extensive experience navigating the legal risks and challenges of integrating AI and other novel healthcare technologies. We understand the wealth of current opportunities surrounding AI and support clients as they navigate a range of ever-evolving considerations around its use, including digital health and telehealth regulations, data privacy, data as an asset strategies, the corporate practice of medicine limitations, licensing issues, intellectual property rights, ethical considerations, and protecting against potential healthcare liabilities.

Our full service platform for AI in healthcare covers regulatory, commercial, and transactional matters, such as:

FDA approval pathway for AI as a medical device
Reimbursement and the False Claims Act
Privacy, data security, HIPAA, and state regulations on data access and use
Anti-kickback Statute, the Stark Law, and related fraud and abuse considerations
Instituting compliance safeguards to address and contain risks presented by AI
Assessing and addressing legal risk
Counseling digital healthcare providers and telehealth providers
State and federal regulations addressing the practice of medicine, fee splitting, etc.)
Technology licensing
Intellectual property (IP) strategy and protection
IT contract negotiation
Vendor negotiations and outsourcing
Financing
Deal structuring and negotiation, such as M&A, joint ventures, and strategic collaborations related to healthcare transactions
Due diligence expertise specifically tailored to each sub-industry
Integrating AI functionality into operations
Working with emerging healthcare technology companies and investors

Provider Alignment Transactions

Sheppard Mullin is the preferred law firm for health plans, hospital systems, and providers considering convergence transactions that result in successful provider alignment. In addition to traditional payer contracts, we structure the full range of value-based and risk-based reimbursement arrangements, including full risk and global risk agreements. We have worked with many clients on transitioning to risk-based reimbursement and implementing effective alignment strategies.

We work with leading national compensation consultants to formulate innovative and effective compensation approaches. We are experienced with traditional, shared savings, incentive based and capitated/percent of premium contracting arrangements and can share the best practices we have learned from multiple engagements, as well as structures to avoid. Few other healthcare law firms have our multi-sector practice, which allows us to take the knowledge and experience we gain in one sector and apply it to another.

Health Plan Strategic Transactions, Licensing, Contracting and Compliance

Our national healthcare team is the “go-to” law firm for health plans and providers considering convergence transactions that result in successful plan/provider alignment. We have led some of the largest and most complex industry transactions, and are working on multiple multi-billion health plan and provider transactions. Additionally, our representation of publicly traded and privately-held health plans has included obtaining licensure under state HMO and insurance laws including the California Knox-Keene Health Care Service Plan Act, contracts under the Medicare Advantage, Medicare Prescription Drug and state Medicaid managed care programs, and compliance with Medicare Advantage, Medicare Part D, Medicaid managed care, Federal Employees Health Benefits Program and Marketplace requirements, as well as appeals of agency decisions and dispute resolution if necessary. Our lawyers regularly provide education and training to health plan administration, inhouse counsel, and compliance staff on an array of issues including fraud and abuse, risk adjustment, medical loss ratio and other compliance matters. We:

Represent leading HMOs and insurance companies on projects such as mergers and acquisitions, vendor and provider contracting, joint ventures, risk-based arrangements, physician alignment and population health management initiatives.
Our Healthcare Antitrust practice has been actively involved in multiple negotiations with federal and state antitrust regulators on some of the most complex and heavily scrutinized transactions and has been at the forefront of structuring innovative relationships for both providers and payors undertaking significant transactions, including mergers, joint ventures, intellectual property licenses, and a variety of other affiliations and collaborations.
Advise health plans that are federal healthcare program contractors on a broad array of issues related to program participation including application submissions, bidding and rating requirements, benefit design, provider contracting and compensation issues including the federal Physician Incentive Plan regulations, medical loss ratio requirements, risk adjustment payment issues, employer group waiver plans, marketing, internal investigations, and program and inspector general audits.
Provide strategic advice and counseling to health plans in response to state and federal agency investigations, such as market conduct exams, medical loss ratio audits, Mental Health Parity and Addiction Equity Act compliance, and ACA Section 1557 discrimination complaints.
Represent health plans in litigation, administrative proceedings, and appeals such as denials of initial and service area expansion applications and the imposition of civil money penalties by the Centers for Medicare and Medicaid Services.
Active in the development and implementation of health plan vertical integration strategies including the alignment of physician groups and networks with plans that are designed to lower health plan provider-related costs, increase patient care quality and secure member access to providers by stabilizing the plan’s provider network.
Represent full service and specialty health plans (including dental and vision plans) in a wide variety of licensing, regulatory, transactional and litigation matters, such as L.A. Care Health Plan, one of the largest public health plans in the country serving low-income and vulnerable populations in Los Angeles County.
Provide counseling to health plans in dealing with solvency issues involving their provider networks, working with multiple companies that provide support and outsourcing solutions to health plans, including utilization review, sales and marketing and independent review organizations.

Antitrust Counseling and Compliance

Our Antitrust and Competition Group regularly works on numerous matters at the United States Department of Justice, the Federal Trade Commission), and state Attorneys General. Our lawyers counsel clients and handle litigation involving the federal Sherman, Clayton and Robinson-Patman Acts, as well as state antitrust statutes.

Defense of Antitrust Investigations and Federal, State and Private Party Litigation

Our healthcare antitrust practice has helped our clients navigate investigations and enforcement actions in some of the most complex and heavily scrutinized transactions in the industry. We are at the forefront of structuring innovative relationships for health systems, hospitals, academic medical centers and providers undertaking significant transactions, including mergers, joint ventures, intellectual property licenses, and a variety of other affiliations and collaborations. In our antitrust work, we:

Advise clients in connection with mergers, acquisitions, joint ventures and other corporate transactions, as well as other competitive collaborations and innovative affiliations with competitors that may require state or federal review, or otherwise garner the attention of antitrust enforcement authorities; such arrangements have included forming risk-bearing entities, establishing integrated delivery systems, expanding vertically into the payer or technology space, and implementing shared-services agreements
Provide antitrust advice relating to clinically integrated networks (CINs), value-based and outcomes-based reimbursement models, risk-based contracting, accountable care organizations (ACOs), Medicare bundled payment initiatives, and price-transparency initiatives
Defend healthcare provider clients in extensive private litigation and class actions
Represent our clients in connection with civil and criminal investigations by the Federal Trade Commission, the Antitrust Division of the Department of Justice, and state Attorneys General arising out of M&A activity, as well as conduct matters
Develop and assist our clients to create and maintain robust antitrust compliance programs consistent with federal antitrust enforcement authority guidance and expectations

Medicare Advantage, Medicare Prescription Drug, Medicaid Managed Care and ACA Marketplace Operations and Compliance

We advise health plans that contract with federal or state agencies under federal health care programs, including Medicare Advantage, Medicare Party D, and Medicaid managed care, as well as the ACA Marketplace and the Federal Employees Health Benefits Program. We assist health plans in applying for initial contracts, filing rate and benefit bid submissions, medical loss ratio, risk adjustment, changes of ownership, and appealing agency adverse decisions.

HCC-RAF Contracting Programs and Provider Incentive Programs

For many Medicare Advantage providers and plans, Medicare’s risk adjustment reimbursement methodology (the Medicare Hierarchical Condition Category (HCC) – Risk Adjustment Factor (RAF) program) is becoming of increasing and critical importance to success. We have represented both plans and providers on all aspects of their risk adjustment programs, ranging from defending providers in federal HCC-RAF investigations; structuring physician incentive programs (e.g., physician stratification programs) and education programs for risk adjustment activities; counselling on compliance issues and audit issues; and assisting with rolling out or assessing HCC-RAF programs for medical groups, IPAs, risk bearing organizations, and Medicare Advantage plans.

Managing the Enforcement Risks and Compliance

Given the growing enforcement efforts from federal authorities, it is imperative to manage the potential enforcement and compliance risks. In this regard, we have substantial experience advising clients on compliance, including conducting internal investigations, supervising coding reviews by consultants, and, for providers, executing voluntary disclosures and refunds to payors when legally required on HCC-RAF issues. Given our real world experience with both federal enforcement efforts and with effective HCC-RAF coding compliance strategies, we can assist providers and plans in pursing risk management strategies, while allowing for the compliant capturing of diagnosis codes to properly generate revenue that is presently being left behind.

Representation of Plans

Medicare uses HCC-RAF scores to determine the complexity of a given beneficiary’s medical condition. With higher payments made by Medicare for more complex (i.e., sicker patients), Medicare Advantage plans that have robust programs in place to ensure accurate HCC-RAF coding can see increases in top-line revenue for their more complex beneficiaries. We have experience counseling plans on the various components of HCC-RAF compliance and performance. In addition to regulatory compliance and payment issues, risk adjustment programs are also vital to a plan’s analysis of the overall risk present in its member/enrollee pools and ensuring sufficient diversity for financial success.

Representation of Risk Bearing Provider Organizations

We also have experience in working with risk bearing organizations to stratify the pool of physicians and other healthcare providers in their network. These tools enable providers to maximize performance and reward high performing doctors, as well as identify doctors who are struggling and may need additional training, assistance and support to succeed.

Tax and Employee Benefits

Tax

A core component of Sheppard Mullin's tax group is advising on both national and international mergers and acquisitions, including for all healthcare transactions. The group has assisted in analyzing and structuring the form of the transaction, prepared legal opinions addressing the tax consequences of the transaction, and assisted with preparation of SEC materials and proxy statements. Our attorneys have advised on all types of sales, acquisitions and reorganizations, including taxable and tax free:

Acquisitions, sales and mergers
Forward and reverse triangular mergers
Asset-for-stock acquisitions
Recapitalizations and consolidations
Holding company formations and spin offs
Stock-for-stock reorganizations
Roll ups
Management equity rollovers

Our tax partners actively work on healthcare merger and acquisition matters regularly, with additional tax and benefits partners involved as necessary.

ERISA and Employee Healthcare Benefits

Our ERISA and Employee Healthcare Benefits Team has a deep understanding of the organizational, regulatory and corporate structuring complexities facing clients in the healthcare service industry, and the impact those complexities have on employee benefits. Our Team members have extensive experience advising healthcare service industry employers on ERISA’s controlled group/affiliated service group requirements that impact employee benefit plans, as well as planning for and ensuring compliance of multiple employer welfare arrangements (MEWAs) that often arise in organizational structures that are implemented to comply with the prohibition of the corporate practice of medicine. The expertise of the Team runs the gamut for all employee benefits and compensatory arrangements (including executive and equity compensation), and the nuances of developing models for compensating medical professionals.

Labor and Employment

Sheppard Mullin maintains one of the most highly respected Labor and Employment practices in the country, and the largest on the West Coast. Our attorneys represent healthcare employers and their trade associations in providing advice to the industry and managing a number of high profile court cases and administrative actions.

Covenants not to compete are a critical part of healthcare purchase and sale transactions. We regularly analyze proposed restrictive covenants, negotiate and document them and advise on possible exits from noncompete restrictions. We are familiar with the negotiation positions of all the leading physician group buyers with respect to physician noncompetition agreements.
Our legal counsel for healthcare organizations includes the defense of employee termination and contract actions to discrimination and harassment claims before federal and state agencies and courts across the country.
It also includes ERISA and other employee benefit claims.
We have also represented clients in class action and multi-plaintiff litigation before courts and administrative agencies at the federal, state and local levels.
Sheppard Mullin also advises healthcare employers in traditional labor matters. We have been involved with many of the major union organizing campaigns in the healthcare industry. Our attorneys have represented healthcare clients before the National Labor Relations Board in connection with unfair labor practice charges, and recently authored an amicus brief to the United States Supreme Court on a traditional labor law issue of vital importance to the healthcare industry.

Emerging Growth/Venture Capital

Sheppard Mullin is a leading law firm in the representation of emerging and high growth healthcare companies and venture capital funds. Our experience is evidenced by the high level of assistance we provide to our clients in the formation, structuring, financing and growth of new companies. We understand the needs of a rapidly expanding commercial enterprise and provide timely and cost effective legal advice and availability when and where it is needed.

We have assisted with a wide range of legal services geared towards development and growth, such as:

Review of business plans and evaluation of key strengths and weaknesses
Company formation, including selection of the most appropriate type of entity
Corporate governance
Purchase agreements and private placement offering documents
Employment agreements, employee incentive plans, employee benefits counsel and employment law compliance
Angel financings, venture capital financings, equipment financing and joint development arrangements
Patent, copyright, trademark and licensing matters
Internet and e-commerce related advice
Joint ventures and strategic partnerships
Mergers and acquisitions, IPOs and secondary transactions
Tax planning and succession planning
Litigation

We provide more than just legal advice:

Our firm’s established presence in the market enables us to provide added benefits to clients in their quest for financing and potential co-investors. This assistance can range from introductions to funding sources and bankers to negotiating and documenting the terms of the investment.
With offices around the world, we maintain a strong network of relationships with VCs, entrepreneurs and third party experts in the startup ecosystem.
The monthly Sheppard Emerging Company Webinar Program focuses on the legal issues faced by startup and emerging growth companies.
We are familiar with emerging trends and can speak authoritatively as to how proposed terms compare to the current market.

Capital Markets and IPOs

Our capital markets lawyers advise issuers, investment banks and investors in public and private capital markets transactions globally. A number of our capital markets attorneys have experience as senior executive officers or securities counsel for publicly traded companies. We offer practical and creative solutions to companies accessing the public and private capital markets. Benefited by deep regulatory expertise, industry knowledge, and intimate familiarity with our clients and their goals, we help our clients rapidly execute opportunities when the market windows are open, assess and mitigate risks, and maximize returns.

As a complement to our Capital Markets practice, our securities lawyers assist our public reporting clients in all aspects of SEC and stock exchange filing, disclosure and reporting obligations and are experienced in addressing the wide range of issues that confront a public company, as well as its board of directors, management and shareholders. We believe effective public reporting and corporate governance are among the most powerful tools available to advance an organization’s mission and improve its attractiveness to capital markets investors.

Capital Markets Services

Initial Public Offerings
Registered Direct Offerings, Universal Shelves, Takedowns
Rule 144A Offerings
PIPEs and Other Private Placements
Regulation S Offerings, EB-5 Offerings and Other Foreign Securities Transactions
Debt Exchanges/Tender Offers
High-Yield Debt Offerings
Investment-Grade Debt Offerings
Restructurings
Spin-Offs and Other Carve-Out Transactions
SPACs

Ongoing Public Company Services

Mergers, acquisitions, spin-offs and going-private transactions
Corporate governance, including Sarbanes-Oxley and Dodd-Frank compliance
SEC, NYSE, NASDAQ, LSE and AIM reporting and disclosure requirements for US and non-US issuers
Audit, compensation and governance committee matters
Internal investigations
Fairness opinions
Contested shareholder proposals
Directors’ and officers’ liability and insurance
Executive compensation and employee benefits
Supply chain management issues

Certificate of Need

We offer clients a full service regulatory, reimbursement and licensing practice, including certificate of need processes. Our compliance and white collar/false claims practices are very active. On the compliance side, we provide licensing, regulatory and reimbursement advice to a broad range of healthcare providers. We regularly are involved in licensing, accreditation and survey/audit issues, including many “bet the company” situations. Our white collar/false claims practice has multiple multi-million dollar cases relating to outpatient surgery centers, DME providers and hospital systems.

Women in Healthcare Leadership Collaborative

Sheppard Mullin’s Women in Healthcare Leadership Collaborative (“WHLC”) is an innovative, exclusive national leadership initiative designed to support women who are in or are advancing into leadership positions within the healthcare and life sciences industries.

Drawing upon Sheppard Mullin’s nationally-ranked healthcare law practice and the firm’s leadership in diversity, equity, and inclusion, WHLC provides its members with critical industry insights and unique quality networking opportunities.

Membership in WHLC is by invitation only. If you or someone you know would like to join WHLC, please contact whlc@sheppardmullin.com.