There has been one constant in Chris Shaughnessy’s 30-year career in healthcare law: change. As the most regulated industry in the American economy, healthcare has an ever-evolving set of rules and requirements that grow more complicated by the day. Chris diligently helps his clients maintain compliance, whether through writing compliance opinion letters, drafting Certificates of Need, assembling physician contracts, or conducting regulatory “check-ups” for providers.

In the realm of healthcare regulation, Chris can handle any legal matter his clients can think of—and even the ones that never would’ve crossed their minds. Chris is especially experienced with the painstaking, detail-oriented work of drafting compliance opinion letters regarding the federal physician self-referral prohibition (known commonly as the Stark Law) and the Anti-Kickback Statute, as well as their myriad state fraud and abuse law counterparts. This work of analyzing and recommending adjustments to the financial structure of a healthcare business is essential to any transaction or proposed deal. He has completed numerous such regulatory analyses for many types of providers, including group practices, hospitals, physician-hospital organizations, physician organizations, physician owned distributorships, equipment leasing companies, and diagnostic testing facilities. While some attorneys shy away from the granular and even arcane nature of this work, Chris’s knowledge and experience allow him to tackle it head-on.

Chris also assists his clients in the areas of regulatory compliance, Certificate of Need and licensing, survey and certification, health care transactions, physician contracts, professional rights defense, fraud and abuse issues, Medicare and Medicaid reimbursement and appeals, privacy, litigation, and professional and third-party payor credentialing and reimbursement. In addition, Chris counsels and advises clients in regulatory “check-ups”, which allow clients to identify and address potential compliance issues before they occur via employee training and/or the development of appropriate policies and procedures.

Clients rely on Chris to keep them up to date with changing laws and to anticipate and act upon the effects of those changes, whether they pose a risk of pitfalls or present an opportunity for growth. Chris knows that his clients need an attorney who not only possesses knowledge of the laws governing the healthcare system, but who also understands the practical business considerations that drive the industry. This multidirectional approach allows Chris to address regulatory issues in a way that achieves compliance and supports the work his clients do.

In his free time, Chris is an avid fly fisherman, and enjoys traveling to various destinations in pursuit of the sport.

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The physician self-referral prohibition, commonly known as the Stark law, is a complex set of regulations that has constantly expanded since its initial publication in 1995. At that time, Stark only applied to clinical laboratory services. Now, Stark applies to a large number of services (referred to as the “Designated Health Services” or “DHS”) as well as virtually any financial relationship between a physician and the entity performing or billing for the DHS. In short, physicians are prohibited from referring DHS payable by Medicare or Medicaid to any entity with which the physician (or an immediate family member) has a financial relationship unless an exception is met. If no exception exists, severe penalties accrue, including denial of payment, refund of payment, imposition of a $15,000 per service civil monetary penalty and imposition of a $100,000 civil monetary penalty for each arrangement considered to be a circumvention scheme.

I can help you analyze whether the Stark law applies to your relationships and whether there is an exception available. If there is an exception available, I can help you structure your contracts, procedures and policies to comply with Stark. I recommend that you revisit this analysis on at least a yearly basis (if not more frequently) to make sure that your relationships, the DHS you perform, and the law have not changed in a way that has rendered you out of compliance.

Most situations that potentially implicate the Stark law must also be analyzed under the Anti-Kickback Statute and other health care regulations. The Anti-Kickback Statute provides criminal penalties for individuals or entities who knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce business payable by Medicare or Medicaid. A violation of the Anti-Kickback Statute could result in fines of up to $25,000, imprisonment of up to five years, or both. In addition, a violation could result in exclusion from the Medicare program.

There are many other laws, both federal and state, which create potential liability for providers and other health care businesses, including state anti-kickback statutes, state self-referral prohibitions (similar to the federal Stark regulations, but often applicable to all forms of payors). Health care businesses and providers also must be aware of the corporate practice of medicine prohibitions that exist in many states and specific Medicare rules that apply to different types of providers. Some examples of Medicare rules that can cause problems for health care businesses include the Anti-Markup Rule, conditions of participation for various entities, and performance, licensure or certification standards.

Whether you are addressing these issues during business planning or you have a specific concern, I can help you understand and comply with these many complicated health care regulations.