Matt J. Glodowski, Esq.

We are a third-party program management company that supports federal grantees with the implementation and administration of the federal 340B drug pricing program. As Counsel and Compliance Officer, I oversee all regulatory compliance and program integrity operations for our 340B covered entities, ensuring physician-managers, team members, and delegated entities understand and comply with the rules and regulations of the Health Resources Services Administration (HRSA) and other Federal (HHS) and state agencies. I work closely with outside Counsel and vendors, such as contract pharmacies and other administrators, to help optimize program operations and prepare for audits.

Daily Responsibilities include:

• Developing, maintaining, and executing policies and procedures to confirm continual compliance with federal regulations, sub-regulatory guidance, and case law.
• Drafting NDAs, employee-agreements, and multi-party pharmaceutical service agreements related to pharmaceutical purchasing and dispensing.
• Maintain up-to-date knowledge of current and emerging compliance regulations, including restrictions on contract pharmacy designations.
• Assist outside Counsel with internal and external audits to confirm compliance with applicable laws and regulations.
• Develop and maintain system for tracking and documenting compliance violations and recommend corrective measures.
• Partner with senior leadership to provide reporting tools necessary to effectively manage and maximize the profitability of their 340B programs.

As supervising attorney and team lead, I was responsible for providing legal support, oversight and guidance to senior staff and Administrative Law Judges relating to appeals of denied Medicare claims for coverage and reimbursement. As attorney adjudicator, I drafted legal memorandum for individual provider, supplier and beneficiary appeals, including RAC and ZPIC audits, and issued final agency legal decisions on behalf of the Secretary of Health and Human Services for Medicare coverage and reimbursement claims arising under Parts A, B, C, and D. Duties included:

• Supervising a team of 12 attorneys providing individual claim/issue analysis for preparation of legal opinions involving Medicare and managed-care plans.
• Conducting and leading training for newly hired attorneys and support legal staff on a variety of reimbursement issues, overpayment disputes, RAC audits, and related topics.
• Maintaining and organizing a docket of over 500 cases involving services such as DME, inpatient care, hospice, Part B outpatient services, SNF, home health, IRF and entitlement.

• Prepared legal opinions on all adjudicated matters arising under Titles II, XVI, and XVIII of the Social Security before the Hearing Office Chief Administrative Law Judge, including SSI payment waivers, overpayments, underpayments, and entitlement appeals
• Worked alongside Administrative Law Judges (ALJs) with jurisdiction over federal disability appeals to formulate and present legally defensible and fully supported findings, conclusions, and recommendations in well-structured legal memoranda
• Managed a Robust Caseload, utilizing tracking systems, case log documentation, and file organization procedures to ensure timely resolution and effective use of resources.