The New Office of Burden Reduction and Health Informatics: Implications for Healthcare Compliance

You may have heard that, last week, the Centers for Medicare & Medicaid Services (CMS) announced the creation of a new office: the “Office of Burden Reduction and Health Informatics.”

What exactly is this new office supposed to do? According to the press release from CMS, the intent is “to unify the agency’s efforts to reduce regulatory and administrative burden and to further the goal of putting patients first.”

All well and good. But what does that actually mean?

Value-Based Care

Here’s one thing that CMS says clearly. They are “committed to leveraging the significant flexibilities introduced in response to the COVID-19 pandemic as we continue to lead the rapid transformation to value-based healthcare.”

We’ve all been hearing about value-based care for years. (Here’s a piece from 2016, for example.) The pace of change hasn’t been particularly speedy, and the pandemic has disrupted most big transformative plans, especially in healthcare.

That said, the Department of Health and Human Services (HHS) is still committed to value-based care. If reducing or streamlining the regulatory environment is necessary in order to make this change happen, you can bet that HHS and CMS will do it.

What specific regulations will CMS change in order to make this happen? That remains to be seen. Recently, CMS did announce that they will be maintaining at least some of the regulatory changes related to telehealth.

Which ones? We know of one rule change that CMS has announced: the proposed physician fee schedule rule, which should come out in July, will include proposals to permanently expand coverage for telehealth services. As of this writing, the rule has not been published, and CMS has not announced details.

With that exception, however, there hasn’t been a lot of movement on specific regulations that could be helpful. In fact, our observations suggest that most regulators are moving back to business as usual. If CMS has plans to streamline regulations to enable the transformation to value-based care, they are keeping those plans very close to the vest.

Improved Review

However, CMS commits clearly to increasing the number of stakeholders – including clinicians, providers and health plans – that it engages with when assessing the impact of new regulations.

This could be a welcome change for compliance professionals, as a more comprehensive assessment of regulatory impact could result in a regulatory environment that’s a lot easier to work within. Clearer regs with reduced expectations would mean less work required by the clinical and revenue cycle staff in your organization.

And that would mean less time spent following up and trying to get staff to do the work.

Health Informatics

CMS has also committed – as indicated in the second half of the new office’s name – to further implement health informatics. The idea here is to effectively use health data in order to provide better care.

CMS gives this as a specific example: “to create new tools that allow patients to own and carry their personal health data with them seamlessly, privately, and securely throughout the health care system.”

This proposal has obvious advantages for both patients and providers. But it could cause significant headaches for compliance.

Staying in compliance with an EHR system for just one health system is challenging enough. What CMS is proposing is an EHR system that applies across all Medicare and Medicaid beneficiaries. This would be much more complicated! The HIPAA implications alone could be staggering.

So, the use of health informatics could make the work of compliance much more challenging. We can all expect that there will be more data available and being used, and more complex tools to manage it. This trend exists across almost all industries, and healthcare is not going to be an exception.

In a highly regulated environment like healthcare, however, big data and big data tools will need to be monitored very carefully. There are a lot of ways that data tools could violate regulatory requirements. If compliance professionals aren’t careful, software and other tools could be put in place that expose the organization to high levels of risk.

Staying Up to Date

As of this writing, there is limited information as to what the Office of Burden Reduction and Health Informatics will be doing for the US healthcare system. It has a broad mandate, with unclear specifics.

There is a possibility that the office will make compliance easier, by more effectively assessing the impact of regulations before imposing them. There is also a (stronger) possibility that it may make compliance more challenging, by creating wide-ranging technological systems that compliance officers will need to monitor carefully.

As new regulations are issued, and new announcements are made, we’ll be keeping you updated. youCompli customers always have access to the latest regulatory changes as they come out and will be well-positioned to adapt to the environment created by his new office.

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Risk and Compliance in Healthcare Organizations: The Department of Justice’s 2020 Guidance on Corporate Compliance Programs

The Department of Justice has just issued updated Guidance on the evaluation of corporate compliance programs. This document is the latest in a series of Guidance documents (prior versions were issued in 2017 and 2019) issued by the DOJ to assist prosecutors who are investigating potential criminal acts in business organizations. What implications does this have for healthcare compliance?

When it comes to healthcare organizations, the DOJ will typically defer to the agencies with specific healthcare responsibility, such as the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS). However, the DOJ guidelines are often relied upon as a “best practice” for developing a corporate compliance program, including a healthcare compliance program. The DOJ is also likely to incorporate healthcare-specific guidelines (such as the Seven Elements of an Effective Compliance Program) along with its own Guidance documents, rather than defer entirely to another agency.

DOJ Guidance Documents Explained

Generally speaking, the DOJ issues these guidance documents in an effort to show transparency to both organizations and attorneys. The intent is essentially prophylactic — that is, here’s what we’re going to be looking for, so make sure that you’re following this; and if you aren’t, you can’t be surprised that we’re asking.

This guidance document is slightly unusual in terms of its strength and scope. It provides all federal prosecutors with a strong mandate to assess and evaluate all aspects of a compliance program, regardless of the industry or nature of the putative misconduct. In other words, as part of a broader criminal investigation, the DOJ will review a compliance program, and use this document to guide their investigation into whether that program was at a sufficiently high standard — or not.

There are three overall questions on which this Guidance is built, along with a number of more specific inquiries to guide prosecutors in determining what, if any, consequences should be applied to the organization. These could include prosecution, monetary penalties, and additional compliance obligations (such as reporting).

Question 1: Is the compliance program well-designed?

The Guidance makes specific reference to a formal risk assessment and resource allocation process. This not only means that a compliance program must start with a risk assessment, but risk assessments must be reviewed and updated periodically, and updates must be made to policies, procedures and controls as necessary, throughout the organization.

The Guidance spins out a number of other specific requirements as well, such as training and communication, and reporting and internal investigations. The punchline, though, is that everything comes out of the risk assessment. Every process and procedure that makes up the compliance program must be aligned with the risks identified by the ongoing risk assessment process.

This means that, at a bare minimum, it is essential that a good compliance program have a strong risk assessment behind it. That assessment must be revisited at regular intervals, and changes in internal controls will need to be regularly made.

Question 2: Is the program effectively implemented?

The DOJ is distinguishing here between what we could call a “real” program, as compared to a “paper” program. In other words, are there appropriate resources to make the program function the way it was designed? Does senior management buy in to the program, and endorse it at a cultural level throughout the organization?

While a risk assessment is where a compliance program begins, the Guidance makes clear that it is in ongoing management and implementation that a compliance program comes to life. Without significant time and resources invested to build the compliance program into the way the organization functions, the program is not going to be sufficient, and the organization will vulnerable to potential penalties.

Question 3: Does the program actually work?

This backward-looking question is intended to assess whether the program was well-designed and well-implemented for the particular organization within which it operates. That is, if misconduct has occurred, was this because the program wasn’t the right program for this organization? Or was the program functioning well, and the misconduct resulted from something else? (DOJ acknowledges that no compliance program will ever prevent every incident of misconduct.)

What DOJ is ultimately looking for here is whether the program changes over time, in response to changes in the organization. If there is misconduct, is it investigated? Are opportunities identified for improving the compliance program to prevent the misconduct in future? Have these remediation efforts actually been implemented? And so on.

Best Practices

Overall, the DOJ has provided a set of clear guidelines that should be used to not only develop new compliance programs, but assess existing ones. Programs which do not live up to the DOJ’s requirements on risk assessments, program implementation, and continuous improvement are more likely to be found to be inadequate. And an inadequate compliance program leaves a healthcare organization at risk.

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The Role of Compliance Professionals During a Pandemic

COVID-19 has had a significant impact on every industry in almost every country. Healthcare is, obviously, one of the most affected sectors, as the number of  ill patients is always rising, and the stock of key medical supplies and equipment is depleting daily.

In these times, it can seem like compliance is not that important. After all, this is a crisis, and lives are being saved and lost. Is compliance with rules and proper procedure really what we should be focusing on?

The answer, of course, is “yes”. In times of crisis, compliance can get lost in the shuffle, but it does not undermine the value or necessity of compliance and compliance professionals both during and after the crisis.  And when the time of crisis subsides, the challenges which remain will require skilled compliance professionals who are able to identify non-compliance and move the organization towards positive change.

To help support you in this time, we’ve put together some important information on the role compliance has to play during a pandemic. Please fill in the form below to download.

Denise Atwood, RN, JD, CPHRM
District Medical Group (DMG), Inc., Chief Risk Officer and owner of Denise Atwood, PLLC
Disclaimer: The opinions expressed in this article or blog are the author’s and do not represent the opinions of DMG.

Denise Atwood, RN, JD, CPHRM has over 30 years of healthcare experience in compliance, risk management, quality, and clinical areas. She is also a published author and educator on risk, compliance, medical-legal and ethics issues. She is currently the Chief Risk Officer and Associate General Counsel at a nonprofit, multispecialty provider group in Phoenix, Arizona and Vice President of the company’s self-insurance captive.  

Cybersecurity: The Nightmare That Keeps Me Up At Night

You are preparing for board meeting, but you can’t get into your reporting application.  You log off the computer and then log back in – no good.  You call the helpdesk and hear what you never want to: “The application is offline due to a potential cyber attack.”

Keeping organization data safe from hackers is a real concern for compliance professionals.  When asked what keeps them up at night, most would say it is the fear of finding one of the IT systems or applications was hacked. The nightmare may be recurring for compliance professionals who work in health care where personal, protected health information (PHI) data is stored in electronic health record applications.

To optimize cyber protection and minimize cyber events, it is recommended that compliance departments partner with their organization’s information technology (IT) and risk management departments.  A good place to start collaborating is to write and implement an organization-wide cybersecurity plan (CSP) based on each discipline’s input, this way input is included from each discipline leading to a more robust plan

As required under HIPAA and HITECH, Compliance and IT professionals generally focus on how to prevent both privacy and security breaches respectively, so the CSP should include prevention steps from both of those aspects.  While risk management includes prevention, risk also focuses on loss mitigation and minimizing impact to the organization’s reputation after a cyber event has occurred.

And the CSP must include ongoing staff education.  While there are many commercially available tools or applications which provide cyber protection against email hackers, phishers, malware, spyware, and viruses, these tools are only as good as the end users working on the organization’s computers.  Of course, the CSP should include appropriate fire walls and penetration testing by an outside vendor to assess the organizations privacy and security vulnerabilities; however, the best prevention is education for staff so they can identify emails which may contain malware, spyware or viruses.

Ongoing education should occur with staff at all levels of the organization.  Education should include internal IT generated phishing emails with remediation for those who “take the bait” and click on the bad links.  It should also include cross-departmental table-top exercises where cybersecurity related scenarios are presented and discussed to ensure familiarity with the CSP and to identify and improve upon weaknesses in the plan, staff education, or the applications used.

PRACTICE TIPS:

  1. Schedule a one-hour call with your insurance broker to review your cyber liability insurance policy and reporting requirements in the event of a privacy or security breach.
  2. Ensure you are current with not only federal, but state security and privacy laws.

Denise Atwood, RN, JD, CPHRM
District Medical Group (DMG), Inc., Chief Risk Officer and owner of Denise Atwood, PLLC
Disclaimer: The opinions expressed in this article or blog are the author’s and do not represent the opinions of DMG.

Denise Atwood, RN, JD, CPHRM has over 30 years of healthcare experience in compliance, risk management, quality, and clinical areas. She is also a published author and educator on risk, compliance, medical-legal and ethics issues. She is currently the Chief Risk Officer and Associate General Counsel at a nonprofit, multispecialty provider group in Phoenix, Arizona and Vice President of the company’s self-insurance captive.