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Types of IRO Reviews

Health care organizations are often required to select an independent review organization (IRO) as part of their compliance obligations under a Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Services (DHHS) Office of Inspector General (OIG). Strategic Management offers IRO services related to reviewing and assessing compliance with the terms of a CIA.

Our firm focuses on creating high-quality compliance and ethical solutions in the commercial, government and health care business sectors. Our team of IRO consultants bring more than 30 years of industry and government experience to address client compliance issues.

For more information on Strategic Management’s IRO Services, please contact lead consultant Tom Herrmann at (703) 683-9600 ext. 410 or therrmann@strategicm.com.

ARRANGEMENT REVIEWS

Arrangements Reviews

A large number of OIG Corporate Integrity Agreements (CIAs) with health care organizations relate to arrangements with referral sources, most often physicians.

CIAs often require IRO reviews related to the arrangements entered into by a health care organization with other health care providers, practitioners, suppliers, and vendors. The IRO is obligated tol review these arrangements to ensure compliance with the provisions of the Federal Anti-kickback Statute and the Stark Law, as well as other CIA requirements.

Strategic Management’s review of arrangements is undertaken by Thomas Herrmann and a team of experts with extensive legal training and expertise in the review of transactions under the statutory and regulatory standards governing such agreements.

Drawing on more than 30 years of legal experience with the Department of Health and Human Services, Tom has assisted clients in meeting compliance requirements of CIAs and has acted as an IRO for a variety of health care providers and practitioners.

Tom Herrmann
Tom Herrmann, JD
  • Juris Doctor, George Washington University National Law Center
  • Bachelor of Arts, Political Science, State University of New York at Stony Brook
  • Member, District of Columbia and Virginia Bars
  • Member, American Health Lawyers Association
  • Member, Health Care Compliance Association
  • Board Member, Ronald McDonald House Charities of Greater Washington DC
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CLAIMS REVIEWS

Claims Reviews

CIAs often require the IRO to conduct claims reviews.  An initial “Discovery Sample” review of claims may trigger a more extensive review of a statistically valid sample of claims.  In addition, a Systems Review that examines an organization’s internal controls related to the claims submission process may be required.  Strategic Management has the unique statistics expertise required to develop a sampling strategy, in accordance with the OIG’s approved RAT-STATS methodology and generally accepted statistical practices, as well as conduct a review of a sample of claims or any other transactional units (arrangements, contracts, etc).

We use certified auditors/coders and medical professionals with specific experience and knowledge regarding the CPT/HCPCS codes recorded on claims submitted to Federal health care programs and reflecting the care services/items that are being furnished to program beneficiaries.

The lead consultant for this line is Dr. Cornelia M. Dorfschmid, Ph.D.,  whose team not only develops sampling strategies, including statistically valid random samples (SVRS), but also evaluates whether claims and transactions meet Federal statutory, regulatory, and medical necessity requirements.

Cornelia Dorfschmid
Cornelia Dorfschmid, PhD, MSIS, PMP, CHC
  • Ph.D. Economics, New York University/ New York City, NY
  • M.A. Economics, Albert-Ludwigs-Universität/Freiburg, Germany
  • B.A. in Law (Vordiplom) Albert-Ludwigs-Universität/Freiburg, Germany
  • M.S. Information Systems, George Washington University/ Washington, DC
  • CIO Certificate in Federal Executive Competencies from the Chief Information Officers University and GWU
  • Member of the Project Management Institute (PMI) and a certified Project Management Professional® (PMP)
  • Member of Health Care Compliance Association (HCCA)
  • Member of American Health Lawyers Association (AHLA)
  • Certified Health Care in Healthcare Compliance (CHC)
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SYSTEMS REVIEW

Systems Review

Many Corporate Integrity Agreements (CIAs) require that an IRO review the systems, processes, policies, and procedures of a health care organization to track, monitor and verify the claims it submits, arrangements it enters into, pricing it assigns to drugs and devices, and marketing and sales activities.

In undertaking such “systems” reviews, Strategic Management has a staff that has the specialized knowledge and experience with the types of systems to be reviewed, as well as the governing Federal requirements and standards.

TRANSACTION REVIEWS

Transaction Reviews

In cases where claims for payment are not the subject of the Corporate Integrity Agreement (CIA), an IRO review may be required of a sample of transactions undertaken by a health care organization, often in the context of claims processes with other health care entities and professionals.

Strategic Management has the statistics expertise to select the sample(s) of transactions to be reviewed in accordance with OIG RAT-STATS and CMS Program Integrity standards. Our review of a sample of transactions is undertaken by experts with training and expertise with the issues to be reviewed, e.g. compliance with the Federal Anti-Kickback Statute and Stark Law, CMS program coverage, claims, and payment standards.

The lead consultant for this line is Dr. Cornelia Dorfschmid, Ph.D., a nationally recognized expert in the field of statistics, who is frequently called upon by law firms and the Government to assist in statistical sampling, error rate calculation, and extrapolation determinations.

Cornelia Dorfschmid
Cornelia Dorfschmid, PhD, MSIS, PMP, CHC
  • Ph.D. Economics, New York University/ New York City, NY
  • M.A. Economics, Albert-Ludwigs-Universität/Freiburg, Germany
  • B.A. in Law (Vordiplom) Albert-Ludwigs-Universität/Freiburg, Germany
  • M.S. Information Systems, George Washington University/ Washington, DC
  • CIO Certificate in Federal Executive Competencies from the Chief Information Officers University and GWU
  • Member of the Project Management Institute (PMI) and a certified Project Management Professional® (PMP)
  • Member of Health Care Compliance Association (HCCA)
  • Member of American Health Lawyers Association (AHLA)
  • Certified Health Care in Healthcare Compliance (CHC)
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UNALLOWABLE COSTS REVIEWS

Unallowable Costs Reviews

A Corporate Integrity Agreement (CIA) often focuses on “Unallowable Costs” included in a health care organization’s cost reports or claims for payment from Federal health care programs.  Pursuant to a settlement agreement with the United States, a health care organization is required to identify such costs that have been charged to a Federal health care program in the past, and make any necessary adjustments.

A companion CIA will require the IRO to undertake a  review of all Unallowable Costs, including those included on Cost Reports, to determine whether they have been reported and adjusted, and are not being claimed in the future in any cost report or information submitted to Federal health care programs.

Strategic Management has staff with the unique financial expertise to undertake such internal financial audits and make determinations regarding the treatment of Unallowable Costs. The lead consultant on these engagements is Steve Forman, CPA. He served for ten years as VP for Internal Audit and Compliance at one of the nation’s largest hospital systems, and also has many years of experience as a health care compliance consultant.

Steven Forman
Steven Forman, CPA
  • Association of Government Accountants President’s Award
  • Association of Government Accountants Authors Award
  • AGA Regional Vice President
  • AGA Chapter President
  • Co-chair, AGA National Professional Development Conference
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MARKETING PRACTICES REVIEWS

Marketing Practices Reviews

Corporate Integrity Agreements (CIAs) often relate to past marketing practices that were undertaken by a pharmaceutical or device manufacturer, managed care organization, or provider.

Strategic Management consultants have the necessary professional training and expertise to conduct such marketing reviews and determine whether marketing activities are being conducted in accordance with Federal requirements and standards.

The lead consultant on these types of engagements is Rita Isnar, JD.  Her team has acted as an IRO and consultant on this topic for a number of health care organizations.

Rita has served as project manager of several multi-team independent review organization engagements for multi-state and national organizations, developed and implemented complex annual IRO work plans, and coordinated between all stakeholders, including the health care entity and the OIG.

Rita Isnar
Rita Isnar, JD, MPA
  • Bachelor of Arts, Political Science, York University, Toronto, Canada
  • Juris Doctor, cum laude, Syracuse University College of Law, Syracuse, New York
  • Master of Public Administration, Maxwell School of Syracuse University
  • American Health Lawyers Association
  • New York State Bar Association
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SECRET SHOPPING / COMPLIANCE REVIEWS

Secret Shopping / Compliance Reviews

In many Corporate Integrity Agreements (CIAs), particularly in the area of pharmaceutical and device manufacturer marketing, and managed care organization marketing and enrollment, a CIA will require the IRO to monitor marketing practices using “secret shoppers”.  Such monitoring may entail having someone (i.e., the secret shopper) pose as a Medicare or Medicaid eligible beneficiary seeking information about a company’s products or managed care plans.

Strategic Management has staffed and managed IRO required secret shops for several managed care organizations under the requirements of the CIA. The lead consultant for Secret Shopping reviews is Camella Boateng, CHC, Senior Associate, who has led in a number of secret shopping teams.

Camella has worked with health care providers such as hospitals, nursing facilities, managed care organizations, and pharmaceutical manufacturers on establishing effective compliance programs. She has also worked as an interim Compliance Officer charged with implementing a health care organization’s Compliance Program.

Camella Boateng
Camella Boateng, MPH, CHC, CHPC
  • Master in Public Health, New York University
  • Bachelor of Science, Biology, College of William and Mary
  • Certified Healthcare Compliance (CHC) Professional, HCCA
  • Member, Health Care Compliance Association
  • Member, Health Care Compliance Association Member, American Public Health Association
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If you need help navigating the compliance requirements of a CIA, including the retention of an Independent Review Organization (IRO), contact us today! Our experts are happy to answer your questions.
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