Overview

Machelle Shields is a Strategic Advisor for EBG Advisors, Inc. She has more than 20 years of experience in all aspects of compliance and ethics, privacy (HIPAA), and reimbursement support and strategy.

Specifically, Machelle:

  • Provides compliance and regulatory services to life science companies, including device/technology reimbursement strategy (coding, coverage, and payment)
  • Advises on the infrastructure needs of start-up device companies and all aspects of compliance program design, operation, and implementation across the entire health care spectrum—physicians, hospitals, Medicare Advantage, device and pharmaceutical companies, and other health care providers
  • Develops and implements fraud and abuse compliance programs for all areas of health care
  • Performs monitoring and oversight for DPAs, CIAs, and corrective action plans
  • Provides HIPAA/HITECH privacy, security, and compliance program implementation and support services
  • Conducts compliance program assessments and Medicare/Medicaid readiness assessments
  • Conducts compliance and privacy/security gap analyses and risk analyses
  • Handles all aspects of monitoring, auditing, compliance diligence, and internal investigations
  • Provides contract support services with a focus on compliance, regulatory, and federal and state privacy laws
  • Advises on health care administration and compliance and academic medicine
  • Drafts OIG advisory opinions

Read more

Prior to her joining EBG Advisors, Machelle was the Senior Executive Healthcare Policy and Compliance Advisor for the Health Law Practice of an international law firm, as well as the President of that firm’s wholly owned regulatory affiliate. Prior to that, she served as Vice President and Chief Compliance Officer for one of the world’s “top 10” medical device companies. During that time, she executed and implemented a Corporate Integrity Agreement (reimbursement focused) and laid the foundation for a second Corporate Integrity Agreement.

Machelle is a Tennessee Supreme Court Rule 31 Listed General Civil Mediator and a Medical Group Management Association (MGMA) Certified Medical Practice Executive. She has also been certified by the Health Care Compliance Association (HCCA) in Compliance, Privacy, and Research Compliance, and holds three coding certifications from the AAPC and American Health Information Management Association (AHIMA). She speaks regularly at industry meetings and is frequently a guest speaker at local and national meetings on ethics and compliance issues.

Read less

Focus Areas

Experience

  • Developed a defensible coding/extrapolation strategy that reduced a $3.6 million recoupment to $86,000.
  • Served as a federal monitor team lead for 18 months for a device company’s deferred prosecution agreement.
  • Served as a monitor for an Office of Civil Rights’ HIPAA Corrective Action Plan with a large academic medical center (for three years).
  • Serves as an oversight organization monitor for a company under a deferred prosecution agreement.
  • Serves as Chief Compliance Officer for multiple entities.
  • Conducted compliance diligence as part of a $3.9 billion acquisition.
  • Handled compliance preparation for a multistate hospice.
  • Developed and implemented a corrective action plan for an academic medical center in a 340B audit that was conducted by the Health Resource & Services Administration and included the manufacturer repayment process.
  • Developed a corrective action plan for a hospital with alleged violations of the Emergency Medical Transport and Active Labor Act (EMTALA), and imposed the “immediate jeopardy” process by the Centers for Medicare & Medicaid Services.
  • Managed a medical practice with clinical- and academic-based physicians, which included serving as a billing compliance committee member for a 400+ physician faculty medical group and handling fraud/abuse and privacy issues and compliance plan development, implementation, and monitoring.
  • Developed a new medical faculty department specifically targeted as the primary care entrance for a 110,000-square-foot multi-specialty center, including handling departmental integration and centralized organization of staffing models, competency models, budgets, billing compliance, protocols (clinical and administrative), procedures, governance, patient flow, cost-benefit analyses, and pro formas.
  • Oversaw human resource development, departmental policy and maintenance procedures, CLIA certification, and compliance with OSHA and Accreditation Association for Ambulatory Health Care (AAAHC) regulations.

Credentials

Education

  • Seton Hall University School of Law (M.S.J., with distinction, 2017)
    • Concentrations in “Health and Hospital Law” and “Pharmaceutical & Medical Device Law & Compliance”
  • Seton Hall University School of Law (Graduate Certificate, 2015)
    • Pharmaceutical & Medical Device Law & Compliance
  • California Coast University (B.S.H.A., summa cum laude, 2011)
  • California Coast University (M.B.A., 2003)
  • California Coast University (B.S., 1996)

Professional & Community Involvement

  • American Association of Professional Coders, Past President Local Chapter
  • American Health Information Management Association
  • Healthcare Compliance Association, Auditing and Monitoring Tools Editorial Board (2010-2018)
  • Life Science Tennessee, Economic Development and Entrepreneurship Committee (2016-2018) and Mentor (2016-2018)
  • Medical Group Management Association
  • Southeast BIO (SEBIO), Past Board Member
  • Southeastern Medical Device Association (SEMDA), Past President, Past Executive Committee, Medtech Women Past Founding Board Member
  • Zero to 510k Accelerator, Mentor

Media

Events

Past Events

Insights

Certifications

  • Certified in Healthcare Research Compliance (CHRC), HCCA
  • Certified Coding Specialist – Physician (CCS-P), AHIMA
  • Certified Medical Practice Executive (CMPE), MGMA
  • Certified Professional Coder (CPC), AAPC
  • Certified Professional Coder – Hospital (CPC-H), AAPC
  • Certified in Healthcare Compliance (CHC), HCCA
  • Certified in Healthcare Privacy Compliance (CHPC), HCCA
  • EMT-IV Technical Certificate
Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.