Our team frequently advises health care providers on state and federal statutes and regulations affecting the security of individuals’ protected health information, including HIPAA and the new requirements under the HITECH Act. We inform clients of best practices for minimizing the legal risks associated with such information, and if need be, how to appropriately respond to regulators and take corrective action in the event of a data breach.

We also help clients develop or update their privacy policies and procedures and draft business associate agreements, patient privacy notifications and information release authorizations. Our broad industry exposure and deep regulatory knowledge empowers clients to quickly and effectively troubleshoot any critical issues that arise relating to authorizations, records requests and personal representatives. We likewise stand ready to defend clients in administrative and civil litigation involving privacy issues.

Our attorneys advise health systems, senior living facilities and physicians on the unique challenges presented by state and federal marijuana laws. We help clients understand, anticipate and proactively manage the risks associated with medical marijuana when permitting patient utilization and physician recommendations. We also provide regulatory and commercial insights to medical marijuana dispensaries and cultivators, helping them grow their businesses and comply as they innovate in the cannabis space.

We assist health care clients in analyzing proposed transactions with referring physicians to minimize risks under federal and state statutes and regulations limiting referrals of patients whose care is paid for in whole or in part by Medicare, State Medicaid programs and other programs using government funds. These include the Federal Stark Law, as interpreted under the extensive regulations promulgated by the Centers for Medicare and Medicaid Services, and the Federal Anti-Kickback Law and the extensive safe harbor regulations under it promulgated by the HHS Office of Inspector General.

Our team has organized many tax-exempt entities providing health care services. We help hospitals and health care systems avoid a variety of tax penalties when entering into contracts and complex joint venture agreements with individual physicians, physician practice groups and other taxable entities. We also deal regularly with questions regarding private inurement, private benefit and the so-called “intermediate sanctions” under IRC Section 4958 for our tax-exempt hospital clients. We ensure that our clients’ transactions are structured to satisfy all applicable Internal Revenue Code (IRC) standards and Treasury regulations. Additionally, we provide direction to clients responding to questions posed by the IRS Exempt Organization Branch and help them secure favorable determination letters.

Our attorneys continue to be at the forefront when it comes to advising health care providers on telehealth licensing, regulatory and reimbursement requirements. We help clients navigate a broad range of issues unique to telehealth, from obtaining USFDA approval for medical devices to handling the IP aspects of cutting-edge monitoring, diagnostics, nuclear and medical imaging systems. Our team also provides experienced guidance on the privacy and security implications of various telehealth platforms, including social media and internet applications that serve as an interface and repository for protected medical records. Finally, while we offer project-based solutions where needed, our approach emphasizes strategies that can be readily adopted as our clients’ telehealth practices grow and new regulations take effect.

With former in-house compliance professionals, we know that many outside consulting firms and self-styled compliance experts often employ a formulaic, one-size-fits all compliance framework. Absent from this framework in many cases is an informed, forward-looking legal strategy. Worse, legal counsel may be engaged only after an issue has developed into a major problem when the appropriate safeguards could’ve been incorporated from the start. Because we’ve seen how these scenarios play out, we know what tactics and remedial measures are apt to preempt them. We work with clients to ensure, both now and going forward, that their business objectives and legal strategy are fully integrated and sustainable at scale.

We draw on over a century of combined experience advising health systems, hospitals, physician practices and other care providers on all manner of regulatory matters. Our clients look to us for experienced judgement and compliance solutions grounded in a rigorous assessment of their distinct risk profile, business, and care delivery model(s). We put their goals front and center while bringing our deep understanding of health law to bear on the regulatory challenges they face on a routine basis.

Complacency can be the Achilles heel of even the most robust compliance program. That’s why we dig in, ask the right questions, and work with you at every step to keep your compliance program current and airtight. While we offer project-based solutions where needed, we also believe that sustainability is paramount to health care compliance, and our approach emphasizes strategies that can be readily adapted in response to institutional and regulatory change.

We can be called on the provide informed counsel on whatever topics our clients may need, including:

• Program effectiveness evaluation
• Program design/implementation
• Policies and procedures
• Education/training
  • Board of Directors
  • Managers
  • Employee orientation
  • Annual compliance refresher
  • Fraud and abuse
  • Physician practice
• Medicare enrollment
• Transactions
• Coding/billing audits
• Investigations and disclosures
• RAC appeals
• Value-based purchasing
• 340B
• Provider-based requirements
• EMTALA
• Telemedicine

We are always available to answer questions whenever an issue arises or wherever an opportunity presents itself. In addition to providing ground-level support, we make sure our clients are up to speed on industry best practices as well as the latest developments in the world of health care compliance, including hot topics like telemedicine, 340B, and provider-based regulations. Visit our Health Law Matters Blog and subscribe to get timely updates.