Collaboration Between Compliance and Risk: What is Permissible?

Compliance departments, generally speaking, guide staff and boards of directors to comply with the requirements, laws and regulations that govern the organization’s business. They also monitor for compliance via internal audits.  Risk departments, on the other hand, address ways to mitigate risk to an organization through such activities as the evaluation and purchase of insurance policies.  Given the broad nature of the scope of these two departments within the organization, when is compliance and risk collaboration permissible?

Possible collaborations

  1. Strategic planning: Collaboration here should include not only compliance and risk but the entire organization and the board of directors, if applicable.
  2. Disaster response and business continuity: As with strategic planning, disaster response and business continuity planning should also involve input and collaboration from all departments in the organization.
  3. General security and privacy : Here the compliance/privacy officer, information technology/security officer, and risk management director should all be included in the planning.
  4. Known security threat and/or breach incident: Compliance, information technology (IT), and risk management would all participate in mitigating a security threat or breach incident on the organization. Each would provide input and guidance on their respective areas of knowledge.
  5. Risk assessments, gap analysis and mitigation plans: Again, the development of these plans should include leaders from the entire organization; moreover, compliance and risk would specifically collaborate on the assessment, analysis and mitigation activities.
  6. General policy development: Compliance and risk staff can collaborate and provide feedback and input for all organization policies.
  7. Record and document retention schedule: Here compliance and risk can collaborate with legal counsel to ensure record and document retention policies comply with state and federal laws.
  8. Staff education: This is an area where compliance and risk can collaborate to provide training, whether it is done in person, virtually, by email or via online course.

Collaborations to vet and evaluate permissibility

  1. Security breach: As noted above, compliance, IT, and risk will work together once a security breach has been identified. It is important to ensure compliance addresses HIPAA related information and potential reporting requirements; IT evaluates the technical aspects of the breach; and risk focuses on reporting to the insurance carrier and mitigation strategies in conjunction with compliance and IT. These collaborative activities will usually take place under a breach coach or law firm to protect the confidential nature of the breach.
  2. Shared work areas: Depending on the confidential nature of discussions, say a lawsuit against the organization, it may or may not be appropriate for compliance staff to be privy to such information. So shared work areas should be closely evaluated.
  3. Shared staff: As with shared work areas, if a staff member such as a registered nurse (RN) is shared between the compliance and risk department, both leaders and the RN must remain in the scope of the job role in which they are working at the time.
  4. Reporting to the board: Typically, compliance reports to the organization’s leader (such as a CEO) but also has direct or dotted line reporting to the board of directors. Make sure any collaborations with other departments do not create potential conflicts of interest with reporting up this chain of command.
  5. Committee membership: As with the analysis discussed above, make sure to vet compliance staff member membership on the risk committee and vice versa to avoid any actual or potential conflicts of interest.

Goal

All organizations should work to develop a culture where permissible collaborations between compliance and risk occur. They should also make certain that staff feel comfortable calling the compliance or risk department with potential concerns while ensuring the staff not crossing any lines when it comes to compliance or risk department confidential matters or conflicts of interest.

PRACTICE TIP:

  1. Evaluate opportunities for the compliance department to collaborate with the risk management team, as noted above.
  2. Access youCompli to find resources which address required document and record retention requirements.

Denise Atwood, RN, JD, CPHRM

District Medical Group (DMG), Inc., Chief Risk Officer and Denise Atwood, PLLC

Disclaimer: The opinions expressed in this article or blog are the author’s and do not represent the opinions of DMG.

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The Pandemic Is No Excuse: Enforcement Actions Taken by the Office for Civil Rights

We’ve known that enforcement actions were going to pick up again, even though many regulations are still waived or modified during the public health emergency. In the past few months, several decisions have been rendered by the Office for Civil Rights (OCR) which prove the point. Hospitals and other healthcare organizations need remain cautious and cognizant of exactly which regulations are being enforced, and make sure that existing procedures and policies are being followed. 

Religious Rights 

For exampleOCR resolved a complaint against Prince George’s Hospital Center of the University of Maryland Medical System (UMMS). The complaint was raised by a woman who wanted to have a priest attend her critically injured husband during the pandemic. Despite the priest’s willingness to wear any necessary personal protective equipment (PPE), he was refused entry. UMMS implemented a new policy guaranteeing “adequate and lawful access to chaplains or clergy” in order to resolve the complaint. 

second religiously-based complaint was also resolved recently by OCR. In this complaint, filed by a civil rights group, a medical student at Staten Island University Hospital (SIUH) in New York City was ordered to shave his beard, which he kept for religious reasons. The hospital stated that this was in order to ensure his N95 respirator mask had a tight seal around his nose and mouth, even though he had passed a fit test. In resolving the complaint, SIUH provided the student with a Powered Air Purifying Respirator (PAPR) as a religious accommodation. 

Privacy 

OCR also recently resolved a HIPAA-based complaintLifespan Health System Affiliated Covered Entity (Lifespan ACE) in Rhode Island agreed to pay OCR $1,040,000 and to implement a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules related to the theft of an unencrypted laptopNot only did the laptop contain electronic protected health information (ePHI) for 20,431 individuals, OCR found systemic noncompliance with HIPAAincluding lack of encryption on laptops and a lack of device and media controls. 

A Warning for Compliance 

All these enforcement actions took place during the COVID-19 pandemic. The presence of the pandemic is not being taken as a reason for not proceeding with enforcement action. Compliance professionals need to be very aware of what regulations still apply, and how their organizations are continuing to stay within the scope of existing regulations. 

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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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Not All COVID-19 Regulations Are Created Equal

You’re struggling to keep up with all the regulatory changes that COVID-19 has created.

Many of these changes have been short and straightforward… but not all of them.

After analyzing one CMS reg (85 FR 27550), we created a 19-page policy document!

The reg’s primary purpose expanded the range of practitioners who can order — and thus be compensated by Medicare and Medicaid — home health services. It also covers a wide range of other revisions for testing, telehealth, medical equipment, and so on.

Our system broke the regulation down into its core requirements — that is, the pieces of the reg that healthcare compliance and clinical professionals need to know about. Then it was reassembled into this document and placed in an order that makes sense.

You can view the whole document by clicking this link.

Every change to a previous procedure is highlighted in red, and it includes hyperlinks to skip around.

Everything is written in clear language, so it’s easy to follow and implement.

Want us to do the same for your organization and the regulations you’re managing? Set up a quick meeting here and let’s get started.

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Highlights from OIG’s Semi-Annual Report to Congress

Late last week, the HHS OIG made available its semi-annual report to Congress summarizing OIG activities occurring from October 1, 2017 to March 31, 2018. As one might expect, OIG continues to commit resources to enforcement-related activities and to improve its data analytics capabilities. A few of the “headlines” from an enforcement perspective include: Criminal […]

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