Resources for healthcare chief compliance officers to understand the impact of the Cures Act and information blocking. Includes examples and definitions.
Continue readingThe 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 example, OCR 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.
A 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 complaint. Lifespan 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 laptop. Not only did the laptop contain electronic protected health information (ePHI) for 20,431 individuals, OCR found systemic noncompliance with HIPAA, including 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.
Emergency Preparedness Revisited
Emergency preparedness has always been one of the top concerns of hospital administrators and medical staff, but never has it been more critical. As the the coronavirus pandemic continues to impact the United States, and facilities are struggling to maintain levels of personal protective equipment (PPE) and ventilators, administrators and compliance professionals should also review the updated federal emergency preparedness requirements, published by the Centers for Medicare and Medicaid Services (CMS) in the Federal Register on September 30, 2019.
We previously blogged about these requirements in 2017, but the requirements have changed in the past few years. Here are the four core elements of a hospital’s emergency preparedness plan to handle natural and man-made disasters — and a look at how they are impacted by last year’s final rule revision by CMS:
Risk Assessment and Planning
Commonly referred to as the emergency plan, CMS requires such a strategy to be developed and then updated at least once a year. It is based on certain risk assessments and uses an “all-hazards” approach that focuses on hospital capacities and capabilities, care-related emergencies, equipment and power failures, communication interruptions (including cyberattacks), and interruptions to water, food, and medication supply chains.
A major change to this element involves hospital climate control and power. Facilities are no longer required to heat and cool the building evenly. However, safe temperatures are to be maintained in areas deemed necessary to protect patients, other people in the facility, and provisions stored in the facility during the course of an emergency, as determined by a risk assessment. If a hospital is unable to maintain safe temperatures, it should follow an established plan for a timely relocation/evacuation that avoids patient exposure to harmful conditions. Additionally, hospitals are required to have an essential electric system with a generator that complies with the NFPA 99 – Health Care Facilities Code.
Like before, the plan must include strategies for addressing emergency events and include a process to work in conjunction with local, tribal, regional, state, and federal emergency preparedness officials. But the key change to the all-hazards approach — and this is crucial in light of recent events — is that all participating hospitals must be prepared for emerging infectious disease (EID) threats, such as the coronavirus. EIDs may require modification to standard facility protocols to protect the health and safety of patients and personnel, such as isolation and PPE usage.
Communication Plan
This element received additional fine-tuning. Participating hospitals still must develop a communication plan that complies with local, state, and federal laws and the plan must be reviewed and updated annually. It should now also include the names and contact information of key hospital personnel for local, tribal, regional, state, and federal emergency preparedness officials. And, it should detail how patient care is coordinated within the facility, across healthcare providers, and with local and state public health departments and emergency management systems.
Policies and Procedures
Hospital policies and procedures still must be based on the emergency plan, risk assessment, and the communication plan, and must be reviewed and updated at least once a year. They should address a broad range of topics and situations, including subsistence needs (water, food, medical supplies) of patients and staff, emergency staffing strategies, tracking the location of on-duty staff and patients during emergencies, sheltering-in-place plans, and patient relocation/evacuation plans.
Training and Testing Program
This revised element the result of an additive process. Program development is based on the emergency plan, the risk assessment, the communication plan, and the policies and procedures. As before, the final rule states the program must detail who needs to be trained, describe the frequency of training, how knowledge is assessed, and document how the training was conducted.
During the course of normal events, hospitals are required to annually conduct a mock disaster drill that is either a full-scale, community-based or individual facility-based exercise. In addition, hospitals must also hold a discussion-based tabletop exercise with its senior staff to discuss hypothetical emergency scenarios and reassess policies and procedures. But recent years have not been normal.
Along with the coronavirus outbreak, many parts of the country have suffered from an increase in natural disasters or mass shootings. The final rule revision acknowledges this wide spectrum of emergencies. If there is an event that activates a hospital’s emergency plan, that facility is exempt from holding its annual mock disaster drill for one year following the incident, provided it has written documentation. If a hospital activates its emergency plan twice in one year, it is exempt from both the mock disaster drill and tabletop exercise for one year following the actual events. Again, written documentation of these events and procedures is required.
Maintain Compliance with CMS
Being compliant with the September 30, 2019 final rule is a requirement for your facility’s Condition of Participation (CoP) / Condition for Certification (CfC) with CMS. Failure to comply, even during a pandemic, could thus have significant impact on your organization. The youCompli compliance management software is a powerful tool to help mitigate risk and enable your hospital to effectively implement these, and many other, regulatory requirements. The software is easy to use and quick to deploy, and can be a powerful means to drive efficiencies through your compliance department.
For Hospitals, Climate Change Compliance Pays. Literally.
Hospitals nationwide are trying to recover from what AHA president Rick Pollack calls a “triple whammy.” Between “increased expenses incurred in…caring for the COVID patients,” “the decreased revenues” from “having shut down regular operations in terms of scheduled procedures,” and “the increased number of uninsured,” it’s probably no surprise that, according to AHA estimates, US hospitals are losing as much as $50 billion a month.
What is surprising, though, is how hospitals are offsetting some of those losses — to the tune of tens or hundreds of thousands of dollars a year — with significant savings from climate change sustainability. In principle, this boils down to cutting waste — wasted food, wasted paper, red bag waste, wasted electricity — and associated disposal costs.
Climate change regulations are complex, and are likely to change over time, as climate change becomes a more serious issue for regulators. Establishing a program now that fits within existing regulations, has potential to grow, and will support the hospital’s budget needs — all without violating other compliance requirements — is a significant win for compliance professionals.
As these examples show, there are opportunities now to reduce your climate risk, save money, and stay compliant:
Reduced Consumption
- In Wisconsin, Gundersen Health System reduced food waste by more than 80%, saving more than $150,000 over five years.
- They also found that cutting electricity waste was as easy as changing a light bulb – actually, lots of light bulbs. Retrofitting six buildings’ light fixtures cut electric bills in half, saving 4.4 million KwH and about $265,000 a year. And those are only the direct savings. Replacing incandescent bulbs or CFLs with LEDs produces highly directional lighting. They use 75% less energy and last 25 times longer. They also cut air conditioning costs, because while incandescents give off 90% of their energy as heat, and fluorescents about 80%, LEDs give off next to none.
- Ascension Healthcare saved $53.3 million over 7½ years by reducing energy use in its 141 healthcare facilities in 20 states.
- When Minnesota-based Health Partners went paperless in 2014, their more than 90 hospitals and clinics cut paper use by 8% and saved more than $700,000 over three years. (Before you follow their example, though, you should know which paperwork can go digital and which must be filed in hard copy to comply with federal and state regulations.)
- In Olympia, Washington, Providence St. Peter Hospital decreased water consumption by 58%, saving a total of $2,510,479 on water. What’s more, they earned another $1 million in utility rebates under a state water reduction incentive program. Accomplishing this was as simple as finding and fixing leaks, replacing single-pass refrigeration units, calling a vendor to turn off an unneeded cooling pipe, and installing dual-flush toilets and slowing sinks’ faucet speeds in 165 patient rooms.
- By cutting energy consumption by 23% per square foot in its 12 hospitals and almost 400 sites of care, Advocate Health Care saved $23 million over seven years. And by reprocessing instead of discarding medical devices, they save another $2.1 million annually.
ORs and Medical Waste
- ORs account for 20-30% of a hospital’s total waste, up to 60% of its medical waste, and about a third of its expenses. By lowering the number of air exchanges per hour (ACH) from 25 to 20 (the federal and state required minimum) between surgical procedures, the Cleveland Clinic saves $250,000 a year.
- Health Partners’ waste reduction and recycling program has diverted 793,000 pounds from the ORs of all its hospitals.
- By removing 91,753 pounds of instruments from the reprocessing cycle, Dartmouth Hitchcock Medical Center saved almost $1.5 million.
- Seattle’s Virginia Mason Medical Center cut supply costs by over $3 million in three years by switching to reprocessed medical devices.
Implications for Compliance
Selling these savings to the executive board is easy. Savings like these don’t just go once to your bottom line. They stay there, year after year. What’s more, they can increase your property value by as much as eight times your investment. Reducing energy use can also earn you federal tax reductions and refunds, state matching grants, and electric utility rebates.
From a compliance standpoint, the obvious concern is whether implementing these changes to green your organization will have negative impacts on your exposure to compliance risk. And that’s a big challenge to overcome. What you need is a way get clear insight into what regulations require, and what environmentally-focused options are available.
COVID-19 Testing: New Federal Clarifications for Employers
You’ve probably heard of recent federal legislation affecting insurance coverage for COVID-19 testing and related services, such as the Families First Coronavirus Response (Families First) Act and the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
The federal government has taken steps to require certain kinds of insurance plans to provide coverage for testing (and related services) without cost-sharing, prior authorizations, or other medical management requirements.
New Guidance Issued
On June 23, three federal departments — the Department of Health and Human Services (HHS), the Department of the Treasury, and the Department of Labor — issued a second round of guidance on implementing these provisions.
The Centers for Medicare & Medicaid Services (CMS) has published an FAQ specifically related to the Families First Act which contains some useful information related to this guidance. (Click here to read the full document.)
CMS has confirmed that the Families First Act does not require employers and insurers to pay for COVID-19 testing that is not used for diagnostic purposes. This includes back to work purposes or general screening. And there are no exceptions for the uninsured or those receiving Medicaid coverage.
In the case of diagnostic testing, the law allows for quite a broad range of coverage. Tests must be approved by HHS (which includes tests approved by the Food and Drug Administration (FDA) on an emergency or temporary basis). But as long as one of these approved tests is ordered by an attending health care provider, “where medically appropriate for the individual,” then insurers must pay for it. And that’s even if there are multiple tests ordered.
COVID-19 Tests Not Covered
However, for tests that are not for diagnostic purposes, things get more complicated. If employers require their employees to have clean COVID-19 tests before returning to work, there are basically two options, neither of which insurance is required to help with under this legislation:
- Pick up the tab for testing themselves, or
- Ask employees to either cover it (which can be very expensive) or line up at one of the free public testing sites.
Implications for Compliance
As with most of the regulatory changes related to the pandemic, the devil is in the details here. Staying up to date on the latest guidance and clarification is the only way to be sure that you are providing the correct information to the rest of your organization.
AHA and CMS to Keep Regulatory Flexibilities in Place
COVID-19 continues to create obstacles and challenges for healthcare compliance professionals. Thriving in this environment means being agile and adaptive.
The AHA’s Requests
Last week, the American Hospital Association (AHA) asked the Centers for Medicare & Medicaid Services (CMS) to keep relaxed regulations in place. Specifically, the AHA is interested in keeping flexibility around telehealth, quality and compliance measures, and bed capacity.
The telehealth changes are ones that have been on the horizon for some time. Essentially, the AHA is asking CMS to continue to allow hospitals to provide a wide range of telehealth services, without limitations as to profession or geographic location. The AHA is also asking for flexibility on billing and payments related to telehealth to be made permanent.
More interestingly, the AHA has also asked that CMS extend regulatory relief related to some quality and patient safety regulations. These include expanding the use of verbal orders, and extending the reuse of PPE.
The AHA has also asked that CMS provide hospitals with a transition period, to allow them to more easily move from pandemic response to ordinary practice. This includes a request for temporary waivers for sanctions and penalties related to HIPAA , and flexibility on audit requirements. And, it includes a request that certain rules and requirements be delayed or suspended.
The Response From CMS
Three days after the AHA released this letter, Michael Caputo, Assistant Secretary for Public Affairs at the Department of Health and Human Services (HHS), tweeted this :
Enough already. @HHSGov expects to renew the Public Health Emergency due to COVID-19 before it expires. We have already renewed this PHE once. Learn more here: https://t.co/QsWSaP6X2D
— Michael R. Caputo (@SpoxHHS) June 29, 2020
The public health emergency is currently set to expire on July 25. However, as of this writing, HHS hasn’t officially announced how long the extension will be
This means that we don’t yet know what will happen when the emergency finally does end. Will HHS give a transition period, as the AHA has requested? Will HHS continue to allow flexibility about telehealth, which they have previously indicated they would?
Staying up to date on this fluid situation is going to be a key task for compliance in the coming weeks.
The Results Are In: What the Data Say About the Impact of COVID-19 on Healthcare Compliance
We keep hearing that COVID-19 changed everything, especially in healthcare. But actual data is pretty thin on the ground.
Mostly, we’ve been hearing anecdotes and stories, many of which are striking. The problem with stories is that they can be unique or unusual, and without the context of clear data, we can’t really tell.
Last week, we got some data.
In May, the Society of Corporate Compliance and Ethics (SCCE) and the Health Care Compliance Association (HCCA) surveyed their audiences on the impact of COVID-19 on their organizations and their work. They received 300 responses, have collated the results, and there are some interesting trends. You can read the full survey results here.
Confirming What We Knew
Some trends are unsurprising, and confirm what we already knew. Survey respondents said they had concerns about the increased risk of compliance failures as a result of the pandemic.
- 77% expected that there would be some increase, or a great increase, in compliance failures.
It’s also unsurprising to see that healthcare saw more of an increase in the number of inquiries being made of the compliance team.
- 42% reported an increase in healthcare
- 30% reported an increase outside of healthcare
Given the number of healthcare-related regulatory waivers and temporary changes that have been issued, this makes total sense.
Positively, collaboration with other departments has been largely unaffected or increased during the pandemic. Compliance is still seen as really valuable to the organization as a whole. The numbers range from 83% to 96% of respondents reporting that collaboration has stayed the same or increased (depending on department).
Differences for Healthcare Compliance
The data also show some surprising trends, specifically related to healthcare compliance.
We know that there has been a huge shift to remote work. The surprising aspect is that the shift is very different between healthcare compliance and compliance elsewhere.
- In healthcare, 60% reported working remotely
- Outside of healthcare, 84% reported working remotely
This gap is big, and hard to explain. Working in healthcare institutions would, presumably, increase the risk of being exposed to the virus. It would have been reasonable to expect that healthcare institutions would do as much as possible to try to get their non-clinical staff set up to work effectively off-site.
What’s even more surprising is that healthcare professionals are less likely to report that the transition to remote work has gone well.
- In healthcare, 47% said the transition had gone better than expected
- Outside of healthcare, 64% said the transition had gone better than expected
The survey doesn’t indicate why this is so. Speculating a little, it could be that the disruption in moving to a remote office, coupled with the sudden influx of regulatory changes, made it more difficult for healthcare compliance professionals to manage their day-to-day work. If this is true, it would also explain why healthcare institutions were less likely to transition compliance professionals to remote work.
There’s another difference between healthcare and other types of organizations, and this suggests things will be difficult for compliance professionals going forward into 2021. In relation to budgets:
- In healthcare, 40% reported a budget reduction
- Outside of healthcare, 31% reported a budget reduction
In short, budget reductions are coming to compliance, as they are going to come to other parts of the healthcare system. (If they aren’t already in place.) As COVID-19 related waivers and suspensions start to expire, compliance is going to have to find a way to do more with fewer resources.
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.
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.