Mr. Wetzel counsels medical device and diagnostics manufacturers, laboratory testing companies, pharmaceutical and biotech companies, and a variety of other health care and life sciences organizations. Mr. Wetzel analyzes complex business arrangements under the Federal Anti-Kickback Statute and state equivalents, the Stark Law, the Beneficiary Inducement Law, the False Claims Act, the Sunshine Act and other laws. He helps structure financial and remunerative relationships with customers and other health care providers, including strategic counseling on sales and marketing practices, innovative value-based arrangements, and discounting and pricing practices. He also conducts due diligence in the context of mergers and acquisitions, IPOs, and financing transactions.
Leveraging his extensive in-house experience in both the multinational setting and the start-up environment, Mr. Wetzel works with clients to develop and implement effective compliance programs. This includes drafting policies and internal control documents; training employees and agents on appropriate customer interactions; conducting risk assessments and audits to help identify potential vulnerabilities or gaps; conducting internal investigations in response to allegations of wrongdoing; and offering strategic guidance on the evolution and growth of life sciences companies’ compliance programs.
Mr. Wetzel’s unique experience also gives clients deep benchmarking insight and a comprehensive view of industry best practices in a variety of areas. As Vice President & Deputy General Counsel at AdvaMed, Mr. Wetzel spearheaded the medical technology’s most recent revisions to the longstanding AdvaMed US Code of Ethics. He also oversaw the launch of the AdvaMed Code of Ethics in China.
Mr. Wetzel also represents health care clients before key federal and state policymakers, including Congress, the Centers for Medicare and Medicaid Services, and the US Department of Health & Human Services Office of the Inspector General.
Mr. Wetzel is an expert contributor to the Washington Legal Foundation where he writes about life sciences, medtech regulation, healthcare law, and government regulation.
Below are links to his articles:
Mr. Wetzel’s recent experience includes representation of:
Transactions
-
CPS Solutions, LLC, a Frazier Healthcare portfolio company and one of the nation’s largest pharmacy and hospital services providers, in its $780 million acquisition of Trellis Rx, LLC, a technology-enabled specialty pharmacy service provider.
-
Senti Biosciences, Inc. in its business combination with Dynamics Special Purpose Corp., a special purpose acquisition company.
-
The purchaser in connection with Cutera, Inc.’s $230,000,000 offering of % convertible notes. Cutera is a leading provider of aesthetic and dermatology solutions for medical practitioners worldwide.
- Symeres, one of the largest European small molecule CRO & CDMOs, in its acquisition of Organix, a specialized organic chemistry services provider.
- Clarus Therapeutics, a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women, in its public offering of shares of common stock
- Altasciences in its acquisition of Valley Biosystems, a non-human primate (NHP) contract research organization operating within the pre-clinical drug development space, enabling NHP research and development.
- B Capital Group in its Series B Preferred Stock financing of Carlsmed, a developer of a spinal implant device and medical system designed to improve outcomes and decrease the cost of healthcare for spine surgery.
- Novo in its acquisition of Ritedose, the U.S. market leader in the development and manufacturing of sterile blow-fill-seal and unit-dose pharmaceutical products, from Humanwell and AGIC.
- Biocon Biologics, a biopharmaceutical company that develops affordable biosimilars, novel biologics & complex APIs, in its agreement with Viatris, a provider of access to medicines, advances sustainable operations, develops innovative solutions and leverages their collective expertise to improve patient health.
- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, in its acquisition of Casimir, a U.S.-based CRO.
Regulatory
- Represents medical device trade association in connection with code of ethics and compliance benchmarking.
- Represents multiple global medical device manufacturers in connection with the development and execution of global compliance programs, including preparing compliance policies and advising on internal controls and systems.
- Counsels multiple advanced laboratory testing companies on all manner of compliance, coverage and reimbursement, fraud and abuse, health care regulatory and government affairs-related matters.
- Advises genetic testing companies on coverage, reimbursement, and compliance issues, including addressing payor disputes.
- Advises multiple late-stage drug companies on matters related to commercial launch, including drug pricing, payor contracting, compliance program set-up, transparency requirements, and patient assistance and support programs.
- Counsels nationwide chain of physician practice groups on health care regulatory and compliance matters.
- Counsels nationwide chain of fertility and reproductive clinics on health care regulatory and compliance matters.
- Advises women’s health and digital health technology companies on legal and regulatory implications of commercial models.
- Counsels home medical equipment and infusion company on compliance with Medicare & Medicaid requirements.
- Represents independent sales organizations in connection with the negotiation of service agreements with large pharmaceutical companies.
- Counsels direct-to-consumer laboratory testing start-up on corporate and regulatory requirements associated with its business model.
- Represents telehealth-based therapy company on compliance, corporate, and regulatory requirements in connection with launch.
- Provides compliance counseling to early-stage pharmaceutical companies in connection with clinical research arrangements and interactions with healthcare providers.
