The Compliance Director will assist in oversight of all ongoing compliance aspects of Inogen's compliance obligations, including managing those obligations related to the Intake, Sales, Billing, and Customer Service teams. The Compliance Director will also be responsible for working with the licensing team to confirm that the Licensing Portfolio is current and compliant with state and federal regulations, and managing aspects of the various employee training programs related to the Compliance Department. This position provides regulatory guidelines for compliant patient onboarding and patient sales. The Compliance Director will assist with internal/ external audits on items such as patient records and company procedures relating to home medical equipment (HME)/ durable medical equipment (DME) and facilitating continuous process improvements across service teams.
Responsibilities (Specific tasks, duties, essential functions of the job)
Utilizing industry best practices conduct operational reviews to assess compliance with federal regulations in keeping with a publicly traded medical device (oxygen) companies.
Develop and implement a compliance program to ensure the organization operates in accordance with state and federal laws
Develops compliance organizational strategies by contributing information, analysis, and recommendations to strategic thinking and direction, establishing functional objectives in line with organizational objectives.
Determine compliance metrics and establish a system for tracking them
Remain up to date on federal and state laws relevant to oxygen equipment and supplies and durable medical equipment
Design, implement, and maintain compliance policies and procedures including, but not limited to, clinical staff credentialing, onboarding compliance and all other internal policies needed to meet new/existing external requirements.
Perform compliance audits to determine whether establish protocols are being followed and where they can be improved
Create compliance resource library for staff members to reference when they have questions
Protects assets by establishing compliance standards; anticipating emerging compliance trends; designing improvements to internal control structure.
Avoids legal challenges by understanding current and proposed legislation; enforcing regulations; recommending new procedures; complying with legal requirements.
Apply and interpret audit and compliance requirements for various departments
Development of a comprehensive training program (review of training materials and other communication) for staff to ensure proper compliance with industry rules, regulations, industry rules and policies.
Establishing self-audit and compliance monitoring programs
Attend intake calls to develop and build out compliance processes and guidelines for sales and intake staff.
Provide regulatory guidelines for Sales and Billing processes for patient onboarding to ensure all standards are applied correctly, thoroughly, and consistently in determining if eligibility (per public and private payers) has been properly demonstrated/supported.
Oversee the retrieval and processing of documentation, including but not limited to, dispensing and/or detailed written orders, medical records, and Certificates of Medical Necessity (CMN).
Conduct routine audits of the Intake Program to ensure compliance.
Responsible for ensuring corrective action resolution within the Compliance, Sales, and Billing teams (as appropriate) in response to findings pertaining to audits of records/ intake processes.
Interacting with external auditors on matters related to audits of the organization’s internal controls and ensure that proper assistance with responses to external audit requests (public and private payers) are provided.
Work in partnership with the licensing team to manage Inogen's Licensing Portfolio across all facilities.
Ensures all pertinent licenses, registrations and certifications to support operations are identified, obtained, and maintained, including the distribution of change notices and/or compliance filings/submissions, as necessary
Investigate state-specific regulations in order to understand business impact and initiate/ coordinate changes as required across affected departments in order to maintain/support company operations.
Ensure state licensing required to support direct to patient sales and insurance/ Medicare reimbursed oxygen therapy services/ respiratory equipment and supplies services.
Build out a multistate compliance onboarding program for clinical staff
Responsible for managing Medicare, State Medicaid and Commercial Insurances recredentialing.
Oversee Inogen's Compliance and Ethics Program.
Maintain regular and punctual attendance.
Comply with all company policies and procedures.
Assist with any other duties as assigned.
Knowledge, Skills, and Abilities
In-depth knowledge of the industry’s standards and regulations
Excellent knowledge of reporting procedures and record keeping
A business acumen partnered with a dedication to legality
Methodical and diligent with outstanding planning abilities
An analytical mind able to “see” the complexities of procedures and regulations
Ability to facilitate external/ internal audits required.
Attention to detail and process improvement understanding required.
Excellent skills with database systems and Excel with capability to compile data from various sources to produce useful reports for trending and verification required.
Capable of compiling data from various sources to produce useful reports and capable of trending and verifying process improvements.
Excellent management skills, both of individuals as well as projects.
Must have strong work ethic.
Excellent oral and written communication skills.
Must demonstrate effective conflict resolution.
Analytical and problem-solving skills and ability to multitask are required.
Must be solutions-oriented problem solver.
Excellent planning, communication and organizational skills are required.
Ability to effectively interface with different departments within the company is required.
Travel required, approx. 20%, In person attendance at facilities in Texas and California will be required at various times.
Qualifications (Experience and Education)
Bachelor's degree in a related technical discipline, required.
Master’s advanced or professional certification, preferred.
12-15 years’ experience in Compliance (as a compliance officer, compliance manager or similar position), required; within the Med Device industry, preferred Including 2 years’ of experience in at least two (2) of the following: product development, manufacturing engineering, quality assurance, or production management, required
6 years management experience, with a minimum of five direct reports, required.
Certified Compliance Professional, preferred.
Advanced knowledge/proficiency in Microsoft Office, required.
A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.