Compliance
Healthcare Compliance Attorney
Clesson Healthcare Law can help build and manage a compliance program that fits your practice, lab, or healthcare company. We work with healthcare businesses in California, Illinois, and Tennessee.
- 20+Years in-houseInside healthcare and life sciences companies
- 3State barsLicensed in California, Illinois, and Tennessee
- C-suiteFormer rolesChief Legal, Chief Compliance, and Chief Privacy Officer
- CIPP/USPrivacy credentialCertified Information Privacy Professional/United States
Compliance is often invisible until something goes wrong. We build practical programs around your business, not generic policies designed for much larger companies.
Craig Clesson spent more than 20 years in-house at healthcare and life sciences companies, including as Chief Compliance Officer. You get experienced compliance counsel without the cost of an in-house team.
A compliance program built to your size
The Department of Health and Human Services Office of Inspector General (OIG) General Compliance Program Guidance, published in November 2023, sets out seven elements: written policies, a compliance officer with oversight, training, open reporting lines, consistent enforcement, auditing and monitoring, and corrective action. OIG has also released additional sector-level compliance program guidances, including to physician practices, hospitals, and clinical laboratories.
These guidances are voluntary, and OIG says (and means) a business your size can (and is expected to) meet each element in ways that fit its resources, such as naming one staff member as compliance contact. We help scale each element to your headcount and risks, and help update the program as the laws and enforcement in this area evolve.
Fraud and abuse rules
The Anti-Kickback Statute (AKS) makes it a crime to pay or accept anything of value for referrals of federal health care program business. The Physician Self-Referral Law (commonly known as the Stark Law) bars physicians from referring Medicare or Medicaid patients for lab work, imaging, and other designated medical services to entities they have a financial relationship with, unless an exception applies. If you run a lab, you also must conduct your business under the Eliminating Kickbacks in Recovery Act, which prohibits conduct similar to the AKS with private insurance carriers and self-paying customers.
State laws reach commercially insured and sometimes self-paying patients too, and California, Illinois, and Tennessee each draw these lines in a different place. This area of law continues to evolve, in the statutes and in how states enforce them. Craig Clesson is licensed in all three states, so one counsel can help review each arrangement before you sign it.
Where compliance questions come from
Your questions usually arrive with a change in your business.
- New service lines
- Medical director and referral agreements
- Lab sales and marketing compensation
- Marketing and patient advertising
- Billing and coding changes
- Telehealth programs
- Laboratory and pharmacy relationships
- Payer record requests
- Investor and board questions
We also help review your ads, website, and patient-facing claims before they run.
Contact us for a free consultation.
If you are a healthcare professional business owner or a healthcare business that is facing a tough question, maybe we can help. Contact us for a free consultation.
Contact us →Programs built from the inside
Craig Clesson spent more than 20 years in-house at healthcare and life sciences companies, in roles that included Chief Legal Officer, Chief Compliance Officer, and Chief Privacy Officer. Each of the three drug companies where he held a legal or compliance role operated under a corporate integrity agreement, the multiyear compliance obligations OIG imposes as part of a fraud settlement.
He implemented the board reporting, auditing, monitoring, and training those agreements require. Your program draws on that work, scaled to your practice or lab.
Training your team can use
Short, practical sessions cover the rules that apply to each role on your team, from owners to front-desk staff.
We help document each session for your compliance file.
Reporting your board can act on
Each compliance report lists the reviews completed since the last meeting and the issues still open.
OIG expects your owners or board to oversee the program, and these reports give them that record.