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Recent articles from Sarah Couture

Essentials for navigating clinical research compliance in skilled nursing facilities

By Sarah Couture RN, CHC, CHRC, CHPC (Principal at Couture Consulting LLC in Indianapolis, IN.); Katy Wane, JD, MPH, CHC; and Joe Zielinski, JD, CHC, CHPC, CHRC Originally Posted on: Compliance Cosmos Clinical research is on the rise in all types of provider organizations. With the promise of new and more effective therapies as well as […]

January 21, 2025

Effective engagement with outside advisers

By Sarah Couture (Principal at Couture Consulting LLC in Indianapolis, IN.) Originally Posted on: Compliance Cosmos Over the course of this calendar year, this column has discussed the importance of and strategies for engaging many different groups of people who impact compliance program effectiveness. From the board and internal stakeholders to vendors and your network of […]

January 13, 2025

How Early Decisions Can Drive the Long Game: A Conversation with Ken Zeko

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

January 6, 2025

Growing Through the Ranks to Trusted Compliance Officer: A Conversation with Courtney Liszka

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

December 30, 2024

The Winding Road from Privacy Expert toTracking Technology Software Solution Developer: A Conversation with Richard Chapman

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

December 23, 2024

The Path from PT to Compliance Officer: A Conversation with Shelly Williams

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

December 16, 2024

Lessons Learned Along the Way from Coding to Compliance: A Conversation with Chris Flanagan

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

November 18, 2024

Moving from Compliance Outside Healthcare to an AMC: A Conversation with Noelle True

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

November 11, 2024

An OT in Compliance: A Conversation with Tony Barger

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

November 4, 2024

From Back Office to the Front Lines - Glena Jarboe

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

November 2, 2024

Engaging the next generation of compliance professionals

By Sarah Couture (Principal at Couture Consulting LLC in Indianapolis, IN.) Originally Posted on: Compliance Cosmos While many of us “fell” into compliance after years in other roles, a new generation of compliance professionals is doing something most of us did not: go to school to study compliance. There are undergraduate, graduate, and certificate programs at […]

October 28, 2024

Risk and Compliance Essentials - Jeff Driver

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

October 21, 2024

And Ethics? - Ryan Meade

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

October 14, 2024

Becoming a Clinical Compliance Expert - Lynn Asher

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

October 7, 2024

Contrasting the Past and Future of Compliance Effectiveness

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

October 2, 2024

Mentoring: A Key to Personal and Professional Growth of Compliance Professionals

By Sarah Couture (Principal at Couture Consulting LLC in Indianapolis, IN.) Originally Posted on: Compliance Cosmos Most compliance professionals are who and where they are because of a mix of factors: hard work, grit, personality, upbringing, etc. Another significant contributor to each person’s success has very likely been people: those who took a chance on a […]

September 30, 2024

The Nursing Foundation Behind the Clinical Research Billing Leader - Tara Krieg

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect with you to hear […]

September 23, 2024

Pursuing Data Compliance - Nick Weil

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect […]

September 16, 2024

A Passion for Investing in Others - Brett Short

So glad you have joined us on the Talking Compliance: Stories and Perspectives From Healthcare Compliance Professionals podcast. We hope it is helpful in your compliance journey. Check out Couture Compliance to find out more about our work and peruse our Blog to find tons more helpful compliance thought leadership. I would love to connect […]

September 3, 2024

Research is Risky Business: Effective Risk Assessments for Your Research Compliance Program

by Sarah M. Couture and Katherine Cohen Originally Posted on: Compliance Cosmos Risk assessment may be somewhat of a buzzword in compliance circles. Compliance officers know their compliance programs should be based on risk, but some may not know where to begin when it comes to developing an approach to risk assessment. The charge is no […]

September 2, 2024

Staying Connected to a Network of Compliance Professionals

Originally Posted on: Compliance Cosmos Being a compliance professional can be a very lonely experience. Many compliance professionals are in smaller organizations where they are the only team members in the compliance department. Additionally, operations may misunderstand compliance or be siloed from effective working relationships with operations’ leaders and managers. And because compliance professionals can be […]

Vendor Compliance Engagement

By Sarah Couture (Principal at Couture Consulting LLC in Indianapolis, IN.) Originally Posted on: Compliance Cosmos This column has been dedicated to the importance of compliance engagement for those within our organizations. While vendors and other third parties—those external to our organizations yet support our work through provision of supplies and a variety of services—may seem […]

Effectiveness Through Investment in Compliance Program Team Members

By Sarah Couture (Principal at Couture Consulting LLC in Indianapolis, IN.) Originally Posted on: Compliance Cosmos In the June 2024 issue of Compliance Today, our column, “Successful engagement and integration of new compliance program staff,” discussed intentional assimilation and development of new compliance professionals and/or those new to our institutions.[1] While a meaningful approach to onboarding newer team […]

Compliance and HR Collaboration Can Drive Effectiveness

by Amanda Bates, MS; Sarah M. Couture, RN, CHC, CHRC, CHPC; and Kasie Ray, CHC, PHR, SHRM-CP Originally Posted on: Compliance Cosmos Scenario It was a crisp fall night in West Texas. Ellen was one hour into her fifth night shift of the week, working overtime for Sandy, who wanted to watch her son’s high school […]

Successful Engagement and Integration of New Compliance Program Staff

By Sarah Couture (Principal at Couture Consulting LLC in Indianapolis, IN.) Originally Posted on: Compliance Cosmos A compliance program can increase effectiveness by intentionally developing compliance program staff. This is especially true for those compliance program staff who are new to our teams and/or who may be new to compliance. When we successfully engage, onboard, and […]

Engaging Frontline Staff: Individual Compliance Responsibility

By Sarah Couture (Principal at Couture Consulting LLC in Indianapolis, IN.) Originally Posted on: Compliance Cosmos A compliance program’s success is seen in its ability to engage each person in the organization—not only senior leaders and managers but all frontline staff—in their individual compliance responsibilities. Compliance is everyone’s job. But how can the compliance program reach every individual […]

Managers: Key to Compliance Program Effectiveness

By Sarah Couture (Principal at Couture Consulting LLC in Indianapolis, IN.) Originally Posted on: Compliance Cosmos It is essential that compliance programs engage their organization’s senior leaders. This is not only an expectation from a regulatory perspective but also critical to fostering compliance program effectiveness. Engaging operations in compliance is vital to ensuring compliance. The March […]

Senior Leadership Engagement

By Sarah Couture (Principal at Couture Consulting LLC in Indianapolis, IN.) Originally Posted on: Compliance Cosmos It is essential that compliance programs engage their organization’s senior leaders. This is not only an expectation from a regulatory perspective, but it is critical to foster compliance program effectiveness. An organization’s senior leadership is made up of executives who […]

February 1, 2024

Compliance Culture Begins with An Engaged Board

By Sarah Couture (Principal at Couture Consulting LLC in Indianapolis, IN.) Originally Posted on: Compliance Cosmos Compliance programs must successfully engage with a variety of stakeholders to ensure program effectiveness. Because of their fiduciary duties and oversight responsibility, compliance programs should prioritize engagement with the board of directors (or a delegated subcommittee). According to Chapter 8 […]

January 1, 2024

The Value of Engaging People for Your Compliance Program’s Success

By Sarah Couture (Principal at Couture Consulting LLC in Indianapolis, IN.) Originally Posted on: Compliance Cosmos Much of a compliance program’s success—and its ability to successfully prevent and detect fraud, waste, and abuse—rises and falls on its strategy and approach with people. The vision and planning of every compliance program must acknowledge that people are essential […]

December 19, 2023

The New OIG General Compliance Program Guidance: What to Know, What to Do

Most healthcare compliance professionals are well aware of the recently published HHS-OIG General Compliance Program Guidance (https://oig.hhs.gov/documents/compliance-guidance/1135/HHS-OIG-GCPG-2023.pdf) (GCPG). Released in November 2023, the resource consolidates, modernizes, and updates compliance guidance for the healthcare industry. This Perspectives will provide an overview of the GCPG, discuss observations, and provide recommendations on how compliance professionals should begin to […]

December 14, 2023

Emerging ERM Lessons from COVID-19: Considerations for Compliance Officers and Managers of Risk

By Jeffrey Driver, JD, MS, and Sarah Couture, RN, CHC, CHRC Originally Posted on: Compliance Cosmos For months, our world, our country, our healthcare systems, and our lives have been drastically altered by the COVID-19 pandemic. It has been impossible to hide from the realities of the pandemic as news, social media, and conversations with friends […]

December 13, 2023

Compliance and the Board: Challenges and Best Practices

By Brian D. Annulis, JD, MHA, CHC, CHPC; Sarah M. Couture, RN, CHC, CHRC; and Kayla M. Teune, CHC Originally Posted on: Compliance Cosmos Chief compliance officers (CCOs) understand the importance of creating a culture that identifies and mitigates risks. In fact, not having a culture that timely identifies risks and escalates them was in the top 10 risks […]

December 12, 2023

Solid as a ROC: Strengthening Your Research Operations Core

By Sarah M. Couture, RN, CHC, CHRC, and Brian D. Annulis, JD, MHA, CHC, CHPC Originally Posted on: Compliance Cosmos Since the inception of ClinicalTrials.gov, “a database of privately and publicly funded clinical studies conducted around the world,” in 2000,[1] the volume of registered clinical trials in the United States has skyrocketed. As of August 9, 2020, there […]

December 8, 2023

Chasing the Goal: How Do You Know if Your Compliance Program is Truly Effective?

By Sarah M. Couture, RN, CHC, CHRC, and Debbie Troklus, CHC-F, CCEP-F, CCEP-I, CHRC, CHPC Originally Posted on: Compliance Cosmos If you are new to compliance, you may have noticed that compliance officers talk a lot about compliance program effectiveness. That is for good reason. According to the Federal Sentencing Guidelines, which provide the reasoning and framework for […]

December 7, 2023

Risk Assessments: Why, What, When, How

By Christopher Tonellato, JD, CHC, and Sarah Couture, RN, CHC, CHRC Originally Posted on: Compliance Cosmos A compliance program can only be truly effective at accomplishing its goal of preventing and detecting fraud, waste, and abuse when the program, its infrastructure (i.e., the seven elements), and the work the program does (i.e., the compliance work plan) are oriented […]

December 6, 2023

Understanding the New Medicaid Research Coverage Regulation

by David A. Mata, Catherine Cruz-Montes, and Sarah M. Couture Originally Posted on: Compliance Cosmos On January 1, 2022, the new Medicaid clinical research coverage law became effective. State legislatures must amend their state plans to provide this new mandatory benefit. Clinical research sites should proactively take steps to address coverage issues, understand the regulation, and […]

December 5, 2023

Compliance Liaisons: Who and Why

by Joseph Zielinski, JD, CHC, and Sarah Couture, RN, CHC, CHRC Originally Posted on: Compliance Cosmos A question facing every compliance and ethics program (“compliance program”) is how to best structure the program to achieve optimal effectiveness (i.e., how to structure it to prevent and detect fraud, waste, and abuse, which is the objective) most effectively. […]

December 1, 2023

Teaching the Essentials and Ensuring Effectiveness

by Sarah Couture RN, CHC, CHRC, CHPC, and Adam Turteltaub, CHC, CCEP Originally Posted on: Compliance Cosmos AT: I’ve enjoyed teaching the Healthcare Compliance Essentials Workshop with you and joining you in the networking events that are a part of it. It’s good seeing so many people who are new to compliance. I’m curious, what do you […]