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Home Featured

The Challenges for and Benefits of Monitors in Health Care

Monitoring in the Health Care Sector, Part 1

by Jay Rosen
August 14, 2019
in Featured
stethoscope in the shape of a heartbeat

Jay Rosen begins a deep dive into health care monitoring and how the proactive use of a health care monitor can positively impact all stakeholders: the regulators, the industry itself and the consumers of health care services, the public.

Independent integrity monitoring can be particularly valuable and important in the health care sector because in many ways, health care is the perfect storm for significant compliance risks – but it also has a greater opportunity to mitigate those risks.

Using an independent third-party compliance expert or monitor can be one strategy to help mitigate risks.

Health care occupies a unique space in the American business world.

The size of the health care industry accounts for almost 20 percent of our economy.

Moreover, a very large – and ever-growing – portion of that money comes from the taxpayers; federal programs like Medicare, Medicaid and the VA; and state-funded programs.

When you have lots of money being spent in an industry, there is always the potential for fraud, waste and abuse. Now, overlay this with the public money involved, and there is the potential for a False Claims Act or government action, whether civil or criminal.

Finally, the health care industry is highly regulated, with most if not all health care providers – whether individuals or organizations – licensed by the state, by a board or state agency or certified by federal authorities.

Not every health care organization has a good handle on either the effectiveness of their compliance program or the compliance culture of their organization.

Independent integrity monitoring can proactively assess compliance programs and culture and identify potential areas of compliance risk. Furthermore, they can help mitigate or limit the adverse consequences of violations and help persuade regulators to look more favorably on an organization.

By using an independent compliance expert to perform a proactive assessment of a compliance and ethics program and culture, a health care organization can receive value by assessing not just whether the organization has a compliance program that appears to meet all the elements of an effective compliance program, but also whether that program truly is effective.

The assessment can identify the ethical culture of the organization, detect gaps, make recommendations to remediate those gaps and provide the organization with a particular level of comfort that the structure of the program is truly effective and that the culture of the organization is such that compliance has been embraced by the workforce from the top to the bottom.

Where there is a compliance issue and the organization has the government looking at it, bringing in an independent compliance monitor can help demonstrate to the government that any compliance violations are not indicative of a systematic problem with the compliance program or the ethical culture of the company.

It can show the problems have been remediated. Through monitoring, the government can feel comfortable that the organization is going to be compliant going forward.

Using an independent integrity monitor can help an organization avoid more severe sanctions, such as license suspension or even exclusion from a government health care program.

There is also value to the government of approving a monitoring relationship in a matter they are involved in. The government and health care regulators want to ensure, above all, that patients and health care consumers receive high-quality, safe care; that taxpayer money is efficiently and well spent; and that there is an environment and culture of compliance, transparency, and quality across the industry.

An independent monitor can help the company meet these objectives and provide assurance to the government that the compliance risks have been addressed.

An independent integrity monitor can work with the government to ensure compliance with an oversight requirement, such as a corporate integrity agreement (CIA) or other resolution agreement.

While an independent compliance monitor typically is going to be an expert in compliance and ethics, the health care industry is incredibly complex. Hospitals must comply with many different regulations; these are different from the regulations with which a health insurance company must comply; and those are different still from the ones a medical device company must follow.

These are but some of the challenges that an independent compliance monitor needs to have expertise in. Please join me next week, when I look at proactive assessments of health care ethics and compliance programs and culture.

In case you missed the earlier installments of this ongoing series, please see the links below.

Everything You Always Wanted to Know About Monitors But Were Afraid to Ask

Part 1, Part 2, Part 3, Part 4 and Part 5

Potential Issues in Corporate Monitorships

Part 1, Part 2, Part 3, Part 4 and Part 5

Suspension and Debarment in Monitoring

Part 1, Part 2, Part 3, Part 4 and Part 5


Tags: False Claims Act (FCA)Health CareMonitoring
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Jay Rosen

Jay Rosen

Jay Rosen is Vice President, Business Development and Monitoring Specialist at Affiliated Monitors, Inc., the first company in the U.S. to focus on providing independent integrity monitoring and assessment services across a wide range of regulated industries and professions. Jay previously headed up Merrill Brink’s FCPA Investigations and Ethics and Compliance translation group. He has over eight years of experience assisting clients on cross-border investigations, as well as helping them localize their code of conduct and other mission-critical English documents for their global colleagues. For almost three years, Jay has co-hosted the #1 weekly FCPA podcast, “This Week in FCPA,” with Tom Fox. Tom and Jay recently launched a second podcast, “Popcorn and Compliance,” and Jay is also a commentator on the biweekly podcast, “Everything Compliance,” with Jonathan Armstrong, Tom Fox, Sarah Hadden, Matt Kelly and Mike Volkov.

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