Gardner Law supports, and even leads the Compliance function for clients.
Gardner Law has deep experience in assessing and mitigating regulatory risk created by the Sales, Marketing, Reimbursement, and Clinical functions. The firm regularly provides counsel on the impact of the law on company programs and how to minimize the risk presented by FDA regulations, the Anti-Kickback Statute, the False Claims Act, the Physician Payments Sunshine Act, HIPAA/HITECH, Stark, the Foreign Corrupt Practices Act, Federal Trade Commission Act and state laws. Enforcement of these laws has become much more aggressive. Companies must now disclose transfers of value made to physicians and teaching hospitals. Many states have additional requirements for nurses, technicians, and therapists. Prescriber data is also public.
These changes are driving new cases against manufacturers and prescribers under off-label promotion, anti-kickback, and false claims prosecutorial theories. Failure to comply with these laws can drive a manufacturer out of business, or worse, put employees in jail. Prosecutors from the Office of Inspector General (OIG) and Department of Justice (DOJ) increasingly take on qui tam plaintiffs (whistleblowers) who sue their employers for alleged violations of these laws.
Companies must be prepared. Leadership, from the Board down, must ensure that Sales and Marketing activities and claims, discounting practices, provision of reimbursement information, and any financial relationships between the company and physicians and hospitals, comply with all applicable laws, regulations and safe harbors.
Gardner Law can provide the peace of mind you need by implementing, managing and offering training for a compliance program designed specifically for your organization – with daily, integrated, hands-on support.
- Supporting the company Compliance Officer in leading the Compliance Function
- Designing and implementing compliance programs that ensure ongoing stability and grow with the business
- Training management teams and staff on compliance laws and regulations
- Analyzing Sales and Marketing programs (e.g., co-marketing, referral education, patient education, reimbursement assistance, physician training, health fairs, disease awareness, patient-assistance, product evaluation, etc.) to assess compliance with various (FDA, CMS, OIG, etc.) rules and regulations
- Assisting companies subject to Corporate Integrity Agreements (CIA), e.g., following up and investigting hotline reports
- Review of discounting practices for compliance with the Discount Safe Harbor to the Anti-Kickback Statute
- Analyze and assess programs and transactions that involve healthcare professionals and entities for compliance with the Personal Services and Management Contracts Safe Harbor to the Anti-Kickback Statute
- Reviewing reimbursement support services and programs
- Conduct compliance audits and compliance risk assessments (of Reimbursement, Sales, and Marketing practices) in order to discover areas of risk, and provide counsel on how to mitigate, wind-down, and/or terminate risky practices
- Internal investigations for alleged improper sales and marketing practices
- Performing healthcare and FDA regulatory due diligence for buyers and sellers, including identify, evaluating and quantifying risks
- Review of research activities as they relate to the advertising and recruitment of clinical trials
- Training on best documentation practices (i.e., writing emails, creating documents, etc.)
- Reviewing contracts and disclosures for appropriate compliance language
- Performing privacy reviews in light of HIPAA requirements
- Assess whether or not a company is a "Business Associate" under HIPAA