The Lawyer’s Guide to Healthcare Compliance in 2023

The landscape of healthcare compliance is rapidly evolving. As emerging technologies, regulations, and policies reshape the healthcare industry, legal professionals must stay up-to-date on the latest developments in order to provide effective counsel. This is especially critical in 2023, as healthcare organizations face new compliance obligations and risks.

For attorneys specializing in healthcare law, understanding the current compliance environment is essential. 

This guide provides an overview of key healthcare compliance issues that legal practitioners should understand in 2023. Topics range from the growth of telehealth and associated regulatory challenges, to data privacy and security concerns, enforcement trends, best practices for compliance programs, and more.

With regulators at both state and federal levels placing greater scrutiny on healthcare organizations, compliance should be a top priority. By gaining insight into the critical healthcare compliance trends of 2023, legal professionals can better advise clients and ensure they avoid penalties. As the convergence of technology, data, and healthcare continues accelerating, healthcare lawyers have an important role to play in navigating the complex legal and regulatory landscape.

The Impact of Telehealth on Healthcare Compliance

The rapid growth of telehealth services presents new healthcare compliance considerations in 2023. Telehealth usage increased dramatically during the COVID-19 pandemic, with over 52 million telehealth visits occurring in 2020 compared to just 840,000 visits in 2019.

While telehealth improves access to care, it also introduces new legal and regulatory challenges. Lawyers advising healthcare clients must ensure compliance with telehealth regulations at both state and federal levels. Key issues include licensure requirements for out-of-state telehealth providers, reimbursement policies, informed consent, and privacy and security.

For example, the Advanced Cardiac Life Support (ACLS) certification in lifesaving skills may be required for cardiologists providing telehealth services across state lines. Healthcare attorneys should research and understand the latest telehealth regulations impacting their clients. Ensuring the privacy and security of patient data is also critical during virtual care. As telehealth continues growing in 2023, ongoing legal guidance will be key for healthcare organizations to avoid noncompliance risks.

Data Privacy and Security in Healthcare

Protecting sensitive patient health information is an increasingly important issue in healthcare compliance. Healthcare organizations must comply with regulations like the Health Insurance Portability and Accountability Act (HIPAA) and state privacy laws when handling patient data.

Recent years have seen more healthcare data breaches, with 145 breaches reported in just the first quarter of 2023. 

Attorneys must ensure their healthcare clients have reasonable data privacy and security safeguards in place. This includes technical protections like encryption, access controls, and cybersecurity tools. It also requires training staff on proper data handling per HIPAA and developing comprehensive policies and procedures.

Legal counsel should advise clients to conduct risk assessments and audits to identify potential compliance gaps related to data protection. Quickly responding to and containing any breaches is also critical. With regulators focused on enforcing privacy and security standards, proactive guidance on data protection compliance will be key for lawyers in 2023.

Regulatory Scrutiny and Enforcement Trends

In 2023, healthcare organizations face increased scrutiny from regulators and more enforcement actions for noncompliance. Attorneys serving healthcare clients should be aware of the latest enforcement trends and high-risk areas.

Key areas of focus for regulators include data privacy and security, Telehealth services, billing and reimbursement fraud, kickbacks and inducements, off-label pharmaceutical marketing and improper prescribing practices. Both federal agencies like the Department of Justice and Health and Human Services’ Office of Inspector General, as well as state regulators have ramped up audits, investigations and penalties. For example, the Biden administration has dedicated more funding towards healthcare anti-corruption initiatives. 

Healthcare lawyers should advise clients on strategies to mitigate risks, including: internal audits, employee training, self-disclosure programs, and implementing robust compliance programs. Promptly responding to any detected offenses and cooperating with investigations is also critical to avoid harsh penalties. Staying abreast of emerging enforcement priorities will enable legal counsel to provide proactive compliance guidance to healthcare organizations in 2023.

Emerging Issues in Healthcare Law

Several emerging legal issues are impacting healthcare compliance in 2023. Understanding these developments allows lawyers to better advise clients on mitigating risks.

One area to watch is the intersection of law, policy, and medicine around reproductive healthcare. Changes to reproductive rights in certain states create compliance implications for organizations like abortion providers or travel companies. Guidance is needed to navigate rapidly shifting legal terrain.

Telehealth also continues posing new legal questions around interstate practice, informed consent, prescribing guidelines and reimbursement. Meanwhile, laws governing data privacy, security and patient access are evolving quickly. Healthcare attorneys must research the latest local, state and federal policy changes touching their clients.

Other issues to monitor include labor shortages, staff burnout, rising cyber threats, health equity concerns, and staff vaccine mandates. By tracking emerging legal trends and regulatory changes, counsel can keep clients compliant. Adapting compliance programs will be key as healthcare laws, technology and society transform.

Compliance Program Best Practices

Implementing an effective compliance program is essential for healthcare organizations to mitigate risks in 2023. According to the Department of Health and Human Services’ Office of Inspector General (OIG), seven fundamental elements comprise a robust compliance program.

First, organizations need clearly written and accessible policies and procedures that address relevant legal standards and risk areas. Second, designating a compliance officer and compliance committee responsible for oversight and ensuring adherence to requirements.

Another element is conducting effective training and education for all staff on compliance policies and procedures. Organizations must also have open lines of communication allowing confidential reporting of suspected breaches, along with non-retaliation for good faith reporting.

Regular internal monitoring and auditing to quickly catch issues along with enforcement of compliance standards is critical. 

Finally, an effective program requires prompt responses to any offenses and corrective action plans to prevent recurrence. Tailoring programs to address specific risks and continuously evaluating and adapting is key. By advising on compliance program best practices, legal counsel provides crucial value to healthcare clients.

Professional Development and Certification for Healthcare Lawyers

Given the complex and evolving nature of healthcare compliance, ongoing professional education is essential for legal practitioners in this field. Attorneys should regularly assess gaps in their knowledge and pursue targeted training to stay current.

Many associations like the American Health Law Association and American Bar Association offer continuing education for healthcare lawyers. Topics range from regulatory changes, cybersecurity, data privacy, telehealth, healthcare transactions and litigation, and more.

Formal certification is also available to validate specialized expertise. For example, the Compliance Certification Board provides Certified in Healthcare Compliance credentials. The American Bar Association offers board certification in health law.

By investing time and effort in professional development, healthcare attorneys position themselves to best advise clients in 2023. Specialized knowledge and networks gained through training and certification is invaluable given the speed of change.

Navigating State and Federal Healthcare Policy Changes

Healthcare laws, regulations and policies at both state and federal levels see frequent changes that affect compliance obligations. Tracking and understanding these changes is essential for legal practitioners advising healthcare organizations.

In 2023, key state and federal policy issues to monitor include telehealth reimbursement rules, price transparency requirements, data privacy and security standards, abortion laws, labor conditions, value-based care models, and physician-owned distributorships.

For example, some states enacted parity laws requiring private insurers to cover telehealth services comparable to in-person care. The federal No Surprises Act also protects patients from surprise medical bills starting January 2022.

Healthcare attorneys must research the latest policy updates and guidance documents from agencies like the Centers for Medicare and Medicaid Services. Advising clients on compliance implications as policies shift will minimize risks. Proactively planning for likely future changes is also wise.

Conclusion

The healthcare compliance environment grows more complex each year, emphasizing the crucial role of legal professionals well-versed in this field. As new technologies emerge, regulations expand, risks amplify and enforcement sharpens, healthcare organizations need proactive guidance to avoid penalties and reputational damage.

By understanding the latest compliance issues, best practices, policy changes and enforcement trends, attorneys can provide robust counsel to healthcare clients in 2023. However, the need for continuous learning and adaptation remains as the industry reinvents itself.

Healthcare lawyers must actively educate themselves on leading developments and niche areas to meet client needs. Specialized training and certifications in healthcare compliance, along with memberships in key legal associations are invaluable.

With vigilance, healthcare attorneys can help clients successfully navigate the continually shifting compliance landscape. By making compliance a strategic priority backed by sound legal advice, healthcare organizations can improve quality of care and outcomes while engendering patient trust.