Regulatory Compliance

Top Healthcare Regulatory Compliance Lawyers

Healthcare today is regulated by an “alphabet soup” of agencies enforcing an endless list of laws and regulations. We make it our business to understand state-specific requirements and federal Medicare, DEA, FDA, HIPAA and other regulatory issues. We tackle the most complex emerging issues in healthcare and life sciences regulatory compliance today, based on our involvement at a strategic and granular level in virtually every facet of the healthcare industry.

We have defended healthcare providers in investigations and actions before the widest range of federal and California state regulatory agencies. We combine specialized experience in a wide range of healthcare sectors with a proactive and attentive approach, making us the go-to law firm for healthcare regulatory matters. Clients hire us because we navigate the ever-evolving California and federal healthcare laws and regulations with the integrity, experience and insight healthcare providers cannot live without.

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Nelson Hardiman has been on the forefront of guiding clients on corporate practice of medicine (CPOM) compliance issues, both for new ventures and in responding to government investigations and disputes. The largest law firms in America, as well as multiple public companies relying upon the model, turn to Nelson Hardiman for our depth and expertise in the nuances of CPOM compliance. Nelson Hardiman’s work around CPOM includes:

• Establishing CPOM-compliant professional entities and corporate documents in all 50 states
(including particular state requirements for formation, ownership, registration of foreign PCs)

• Preparing CPOM-compliant contracts between professional entities (PCs) and management service
organizations (MSOs) in all 50 states

• Advising on all operational aspects of CPOM compliance, including requirements for ownership,
governance, and management roles; requirements of physician operational oversight and
involvement in decision-making; banking and finance requirements for PCs; issues related to
management fee and intellectual property licensing; and control mechanisms

• Remediating noncompliance with respect to CPOM

• Responding to and defending government investigations of CPOM compliance

• Providing opinion letters and expert witness testimony on CPOM compliance

CPOM has been an increasingly essential issue for all organizations engaged in the practice of medicine and other health professions. Roughly half of all states adhere to varieties of a CPOM doctrine, requiring the entities providing medicine, dentistry, and other health professional services to be owned and clinically directed by health professionals and prohibiting lay-owned entities from employing or contracting with health professionals or otherwise holding themselves out as practicing medicine and other health professions. Nelson Hardiman advises nationally on CPOM compliance across all applicable health professions to which corporate practice restrictions apply (varying from state to state).

Over the past two decades, the “solution” to CPOM compliance has been the development of appropriate management service and practice management entities (most commonly referred to as management service organizations or “MSOs”) that contract with professional entities (most commonly professional corporations or “PCs”) to provide non-clinical services, raise capital, and support the growth of healthcare businesses. The model has proliferated, with dozens of MSOs using the PC-MSO structure to function as public companies (including Amazon subsidiary One Medical, Teladoc, and United Health subsidiary Optum) and thousands more having been acquired or established or rolled up by private equity and other investment groups. Nelson Hardiman is experienced in both setting up the corporate and contractual structures and refining the model after discoveries that it has been structured in a noncompliant or suboptimal manner by other law firms. We routinely establish 50-state compliant structures for organizations from new ventures to established organizations utilizing the model.

As a consequence of the extent to which the use of CPOM has expanded within the industry without being fully understood (let alone regulated) by state medical boards, there is widespread confusion around CPOM. Several states, such as California and New York, are making ongoing and increasing efforts to regulate CPOM. Nelson Hardiman is one of the few law firms that handles both the proactive venture aspects of CPOM and also responds to crises and defends enforcement actions and litigation related to CPOM as well. While the Internal Revenue Service (IRS) has clarified the federal tax treatment of PC-MSO structures, state agencies have taken inconsistent and unclear positions, frequently requiring careful legal guidance. Contrary to predictions from observers that CPOM is an anachronistic concept that would fade away from the American healthcare landscape, CPOM issues remain front and center as significant risk and strategic challenges for healthcare organizations. Nelson Hardiman is called upon regularly to navigate those issues.

In this environment, Nelson Hardiman has come to be known as authoritative in dealing with problems arising related to CPOM. Firm founder Harry Nelson has testified in several high stakes cases as an expert witness on industry custom and practice related to CPOM. In a 2017 case involving a public company threatened with being shut down across dozens of locations statewide over supposed CPOM violations, Nelson’s testimony was decisive in leading licensing authorities to abandon their effort. As a result of that victory and other cases, Nelson has been asked to provide industry-wide guidance on developing standards and best practices.

It is not a surprise that Nelson Hardiman is thought of by many as the leading law firm in the United States on corporate practice of medicine compliance. We stand ready to take on CPOM challenges as they arise.

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Attune to the key issues and emerging trends impacting the healthcare industry, Nelson Hardiman’s healthcare lawyers are adept at managing the data privacy and security concerns that drive the way information is created, stored, and utilized. Hospitals, health systems, healthcare companies and individuals rely on us to navigate regulatory compliance standards and advise on best practices to mitigate risk in an industry impacted by security breaches and emerging healthcare technologies.

Nelson Hardiman combines strategic vision with practical advice to advise on the data privacy and security issues around the collection, analysis, use and disclosure of patient information and related data that is driving success in the healthcare industry.

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Nelson Hardiman advises healthcare providers regulated by the Food and Drug Administration (FDA) including pharmaceuticals, medical devices, nutritional supplements, health treatments and cures. As the go-to law firm for healthcare law, we deliver the ideal combination of regulatory experience and forward-thinking to advise clients on compliance with FDA issues specific to healthcare providers.

Our knowledge and experience with FDA regulations and compliance protects providers wading into this vast and highly-regulated space. We counsel on every aspect of FDA regulations, concerning the safety of drugs, medical devices, food, cosmetics and other health-related products. Our singular focus and industry experience in healthcare and life sciences laws and regulations protects our clients from the threat of FDA investigations, and puts them ahead of the competition.

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The seismic changes impacting the healthcare industry place increasing burdens of care on the governing boards of hospitals and health systems. Nelson Hardiman partner Rob Fuller harnesses his deep experience in corporate governance as a former hospital COO to lead our transactional team and advise on challenges in a transformed healthcare environment. When healthcare organizations need the guidance and advocacy that comes with deep integrity and experience, they turn to Nelson Hardiman.

We understand the unique business structures of the healthcare sector and the legal requirements of corporate governance. Nelson Hardiman leverages our national reputation for business expertise to ensure that boards, directors, trustees and management teams meet the fiduciary obligations and governance challenges of the evolving healthcare industry.

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Nelson Hardiman navigates Medi-Cal’s complex regulatory landscape with the fortitude and determination of seasoned healthcare attorneys. We have advised some of the largest hospitals and health systems on cases that involved audits, appeals, allegations of fraud and abuse, reimbursement issues and overpayment disputes. Because of our deep experience and our role as industry leaders, we are uniquely qualified to advise healthcare providers large and small on the challenges and opportunities of participation in the Medi-Cal program.

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Nelson Hardiman is a recognized leader in advising and defending Medicare providers in California. For an industry focused on regulatory compliance, we tackle the full range of Medicare-related issues head-on. As Medicare increasingly seeks to contain the rising costs of healthcare in the face of a federal crackdown on Medicare abuse, we help healthcare providers justify the medical necessity of the services they provide and protect physicians from accusations of overpayment and fraud.

Our team of Medicare lawyers develop compliance programs, provide audit assessments, and defend providers who experience problems with their participation in the Medicare program. From enrollment issues to recovery audits, we resolve complex Medicare issues and counsel on Medicare compliance, including Medicare Secondary Payor (MSP) issues. We defend healthcare providers in Medicare Part B recovery audits and appeals. We defend providers from claims by private health plans and payor auditors who pursue reimbursement refunds based on patient Medicare coverage. Whatever the Medicare challenge, Nelson Hardiman has the legal knowledge and experience to navigate the complex landscape of regulatory compliance on behalf of healthcare providers.

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From its base in Southern California, Nelson Hardiman leverages our extensive knowledge of California healthcare laws to advise national and California-based hospitals, health systems and other healthcare providers statewide. The firm’s Los Angeles office gives Nelson Hardiman a strong local presence while operating on a national level.

Our healthcare attorneys provide unmatched legal counsel on all areas of California law and regulations affecting healthcare, including California-specific requirements such as the corporate practice of medicine and the Knox-Keene Act. Recognized for our premiere, cutting-edge healthcare experience, we deliver a formidable combination of strategic thinking and litigation and transactional know-how, frequently working with state and local government to shape the path of healthcare law in California.

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Nelson Hardiman is proud of its expertise and reputation in the highly dynamic field of telehealth, including being on a short list of the leading law firms in the country with the specialized knowledge and experience to structure, operationalize, and support the growth of telehealth ventures. We are proud of our experience of taking telehealth ventures from the “whiteboard” phase of planning through early stage growth through the entire venture life cycle, including Series A, B, and later funding rounds, public company or private equity acquisition and even going public. While we are true experts in compliance for telemedicine and other telehealth ventures, we offer clients a distinctive level of telehealth regulatory strategy on the pathway necessary for growth and success.

Our experience includes counseling telehealth pioneers, such as TeladocAmwell, as well as cutting edge telehealth companies like Lemonaid Health, and mixed telehealth and brick-and-mortar providers like Carbon Health. Teledentistry companies like Byte have relied upon Nelson Hardiman to take them from early stage concept and start-up all the way to acquisition. Many of the most well known brands in telehealth and subspecialties, including telebehavioral health ventures and focused telemedicine modalities have relied upon our unrivalled experience navigating regulatory issues integral to telehealth. We represent telemedical and other telehealth companies from startup to publicly traded companies, and also advise existing brick-and-mortar and institutional providers on regulatory strategy, compliance, and build-out of telehealth services.

Across the nation, telehealth is rapidly evolving and providers must stay current with distinct areas of relevant law, including corporate practice of medicine compliance (including the PC-MSO model), privacy and data security compliance, an understanding of the laws governing distinct modalities of telehealth, supervision, and scope of practice issues, and pharmacy regulatory issues. Few firms combine the depth in both understanding the regulations, agency guidance, and enforcement priorities. The majority of big law firms that claim to provide telehealth expertise are sorely thin on direct experience addressing challenges with state regulators, an area where Nelson Hardiman’s track record of crisis resolution has been invaluable. (It is little surprise that we are routinely brought in as regulatory counsel on telehealth projects by the largest law firms in the country.) Our experience is often the difference maker at all stages in the venture, allowing clients to move quickly while other firms are busy researching issues with which we are already fluent.

The combination of a deep understanding of the telehealth regulatory landscape, enforcement activity and priorities, and what compliance needs to look like throughout the growth of a venture make Nelson Hardiman a compelling choice for telehealth providers. Nelson Hardiman Harry Nelson has been called upon to advise state regulators in evaluating disciplinary issues for health professionals in noncompliant ventures. Although general guidelines have been recommended and there is interest in moving towards national telehealth standards, the legal and regulatory challenges associated with telehealth today typically are highly dynamic across state lines. It is vital to retain experienced counsel in the event of any licensing board accusations or investigations.

Nelson Hardiman has taken dozens of telehealth providers from their starting steps to exit, and is known for its depth of experience in accomplishing its clients’ goals. Whether you are in the planning phases of a telehealth venture or other mobile telehealth platform or looking for new options to provide efficient, on-the-money answers to the most difficult questions, Nelson Hardiman can provide the detailed, proactive counseling and representation necessary to meet your particular business, regulatory, and strategic challenges. Our services span the range of telehealth issues and include, for example: