Neville M. Bilimoria, Author at McKnight's Long-Term Care News https://www.mcknights.com Fri, 22 Dec 2023 17:20:53 +0000 en-US hourly 1 https://wordpress.org/?v=6.1.4 https://www.mcknights.com/wp-content/uploads/sites/5/2021/10/McKnights_Favicon.svg Neville M. Bilimoria, Author at McKnight's Long-Term Care News https://www.mcknights.com 32 32 NLRB’s new joint-employer standard: How it impacts long-term care facilities https://www.mcknights.com/blogs/guest-columns/nlrbs-new-joint-employer-standard-how-it-impacts-long-term-care-facilities/ Fri, 22 Dec 2023 01:20:27 +0000 https://www.mcknights.com/?p=142982 Does your long-term care facility exercise either direct or indirect control of the work conditions for all the outside caregivers and other workers who are on your campus regularly? This will be the important question considered under a new standard for determining joint-employer status under the National Labor Relations Act (NLRA).  

The National Labor Relations Board established the new joint-employer standard under a rule that takes effect for all employers — including both those with and without union employees — on Feb. 26, 2024. Not only does the new joint-employer rule significantly broaden the board’s definition of “employer,” it also increases potential liability and exposure for facilities when they engage staffing agency caregivers or other third-party workers.

Critically, under the new rule, the board can find that a facility is a joint employer with another entity under many circumstances. This may include circumstances where a facility reserves some authority to determine an essential term or condition of employment for the outside caregivers or workers, even if the facility never exercised such authority, or where a facility exerts so-called “indirect control” over the workers’ working conditions.

The board will apply the new joint-employer rule when investigating unfair labor practice charges and union election petitions, as well as when determining whether an entity has any potential collective bargaining obligations. The board’s actions also are watched carefully by other state and federal agencies that investigate and address employment-related issues, such as agencies responsible for handling employee wage payment and unemployment compensation claims and employer tax collection. The board’s new rule may result in other agencies expanding their similar rules for finding joint employer liability.

The development of this new joint-employer rule is just the most recent step in a long history of back-and-forth changes that seem to happen under each change in presidential administrations.  

Most recently, the board under the Trump administration issued a formal rule in 2020 that included a more employer-friendly joint-employer test. That 2020 rule reestablished a narrower threshold for determining joint-employer status under the NLRA, requiring parties trying to prove such liability to show that an employer exercised “substantial direct and immediate control” over workers’ terms and conditions of employment. 

However, soon after changes to the board’s make-up that occurred under the current Biden administration, the board began taking steps that resulted in the new rule that goes into effect on Feb. 26 — assuming there are no successful legal challenges that stop its implementation.

How it works

Once in effect, the board will find a joint-employer relationship if the “employers share or codetermine those matters governing employees’ essential terms and conditions of employment.” 

Sharing or codetermining working conditions will include both reserving the right or having authority to control or actually controlling any of the employees’ essential terms and conditions of employment. Essential terms and conditions of employment include: wages, benefits and other compensation; hours of work and scheduling; assignment of duties to be performed; supervision of the performance of duties; work rules and directions governing the manner, means and methods of the performance of duties and the grounds for discipline; tenure of employment, including hiring and discharge; and working conditions related to the safety and health of employees.  

As you can see, under these very broad categories, for highly regulated long-term care facilities that are explicitly required to maintain minimum staffing levels and ensure all onsite workers comply with health, safety and other care requirements, joint-employer status might be found with practically any third-party worker who provides onsite services. 

Under the prior joint-employer standard, while a finding of joint-employer status between a facility and its agency or vendor workers was possible, the board looked for evidence of significant, direct control over the terms and conditions of the worker’s employment. 

This was still a real risk for long-term care facilities, particularly for onsite, agency-employed caregivers, where a facility inevitably must exercise authority to supervise or direct such workers. Under the new rule, a finding of joint-employer status may be as simple as proving that a facility has health and safety rules that apply to all onsite workers. 

Facilities of all sizes which are already the target of union organizing efforts may find themselves subject to brand new collective bargaining obligations and may have greater exposure for unfair labor practice violations. 

Now is the time for facilities to consider their third-party worker relationships and contracts with staffing agencies and other entities to look at potential joint-employer liability issues. Review your contracts and agreements with all entities that supply workers who work in your facilities.  Carefully consider whether services are necessary for current business operations, whether the services can be consolidated with fewer providers, whether work needs to be performed onsite or at the facility’s specific control or direction, etc. 

If control over the workers is unnecessary, consider eliminating open-ended contract language that reserves all rights to direct and control the workers to the facility. If the workers are necessary, make sure facility staff know whether direct or indirect control and direction of the workers’ tasks is required under the specific circumstances and train managers and supervisors accordingly. 

The risk of a joint-employer finding will be necessary under many circumstances involving onsite agency caregivers, but for other workers, it may not be and facilities should be considering the issue for all work performed onsite. Taking the time to do so now may help avoid major potential risk of a finding of joint employer status down the line.  

Neville M. Bilimoria is a partner in the Chicago office of the Health Law Practice Group and member of the Post-Acute Care And Senior Services Subgroup at Duane Morris LLP, as well as the Cannabis Law Practice at Duane Morris LLP; nmbilimoria@duanemorris.com.

Jennifer Long is a Special Counsel in the Chicago Office of the Employment, Labor, Benefits and Immigration Practice Group at Duane Morris LLP, JLong@duanemorris.com.  Neville M. Bilimoria is a partner in the Chicago Office of the Health Law Practice Group and member of the Post-Acute Care And Senior Services Subgroup at Duane Morris LLP.

The opinions expressed in McKnight’s Long-Term Care News guest submissions are the author’s and are not necessarily those of McKnight’s Long-Term Care News or its editors.

Have a column idea? See our submission guidelines here.

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Cures Act deadlines approach for health information technology developers https://www.mcknights.com/blogs/guest-columns/cures-act-deadlines-approach-for-health-information-technology-developers/ Mon, 20 Nov 2023 17:00:00 +0000 https://www.mcknights.com/?p=141948 Health information technology developers have until December to submit their annual real-world testing plans and to establish their ability to export electronic health information (EHI), with further deadlines approaching in March 2024. 

These deadlines, which come from the 21st Century Cures Act and its implementing regulations, do not apply directly to healthcare providers, but they do apply to a healthcare provider’s IT developers. 

Health IT developers include any non-provider entity developing or offering health IT certified for Cures Act compliance by the Department of Health and Human Services’ Office of the National Coordinator for Health IT (ONC). Since an IT developer’s compliance with these requirements may affect a provider’s own ability to comply with the Cures Act — and bring potential liability for the provider — healthcare providers would benefit from ensuring that their health IT developers are on top of these deadlines.

Effective April 5, 2021, the Cures Act requires healthcare providers to give patients unrestricted access to their EHI. Any conduct that would block that access (known as information blocking) is illegal unless it falls within an enumerated exception. The deadlines imposed on health IT developers enforce this EHI-access requirement by ensuring that providers’ EHI platforms are adequate.

Taylor Hertzler

By December 15 of each year, health IT developers must submit to their ONC-endorsed Authorized Certification Body a real-world testing plan for their health IT. Cures Act regulations establish technological-certification criteria that health IT must meet to enable EHI sharing. ONC authorizes private entities (Authorized Certification Bodies, or ONC-ACBs) to enforce these criteria and certify health IT developers’ compliance with them. Current ONC-ACBs include Drummond Group, Leidos, Inc. and SLI Compliance. 

A health IT developer must submit to its ONC-ACB a plan showing how the developer will ensure its health IT meets ONC’s certification criteria in the upcoming calendar year. Health IT developers must submit the results of their testing from the previous calendar year to their ONC-ACBs by March 15 of each year.

But the key deadline is Dec. 31, 2023, by which date health IT developers must ensure that their health IT can perform EHI export. EHI export consists primarily of the following capabilities: 

  1. Enabling a patient to export electronic files of his EHI on demand
  2. Enabling the export of all EHI in a health IT system
  3. Keeping export formats up to date

Finally, though the Cures Act and its regulations do not specify exact deadlines for this requirement, every six months, a health IT developer must attest that it is compliant with the applicable requirements of 45 C.F.R. §§ 170.401 to 170.405. These regulations provide the above health IT rules, prohibit information blocking and require a series of attestations and notices concerning these requirements.

Health IT developers face hefty fines for noncompliance: up to $1 million per instance of information blocking. Enforcement of those fines began on Sept.1, 2023. Provider penalties, however, have yet to be determined. Providers who commit information blocking will “be subject to appropriate disincentives,” but HHS has yet to provide any guidance on what that means (though a proposed rule is in development).

Until HHS provides such guidance, the extent to which providers may be liable for health IT developers committing information blocking remains ambiguous. On one hand, the Cures Act provides that “healthcare providers [will] not [be] penalized for the failure of [a health IT developer] to ensure that” its health IT system is compliant. On the other hand, the Cures Act also says that a provider who “know[ingly]” commits information blocking will be subject to penalties. 

The interplay between these provisions is similarly ambiguous: one reading would say that if a health IT system is noncompliant, as long as the fault is the developer’s, a provider cannot be penalized for any resulting information blocking, no matter what the provider does; another reading would say that any provider who knowingly uses a noncompliant health IT system will be subject to penalties.

HHS rulemaking may, therefore, be necessary to determine the extent to which providers should be concerned about health IT developers’ noncompliance.  But until such rulemaking arrives, there remains at least potential for providers to face penalties connected with developer noncompliance.  Providers therefore have an interest in ensuring that their health IT developers are on track to meet these compliance deadlines.

Neville M. Bilimoria is a partner in the Chicago office of the Health Law Practice Group and member of the Post-Acute Care And Senior Services Subgroup at Duane Morris LLP, NMBilimoria@duanemorris.com.

Taylor Hertzler is an associate in the Philadelphia office of the HLPG at Duane Morris LLP, TJHertzler@duanemorris.com.

The opinions expressed in McKnight’s Long-Term Care News guest submissions are the author’s and are not necessarily those of McKnight’s Long-Term Care News or its editors.

Have a column idea? See our submission guidelines here.

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Involuntary transfer and discharge cases: Time to take them seriously https://www.mcknights.com/blogs/guest-columns/involuntary-transfer-and-discharge-cases-time-to-take-them-seriously/ Mon, 23 Oct 2023 16:00:00 +0000 https://www.mcknights.com/?p=140976 Combative residents, non-paying residents, disruptive residents, residents needing a higher level of care. We have seen them all the time, but it appears after COVID-19 that more and more facilities are dealing with these “problem” residents and are properly invoking involuntary transfer and discharge proceedings to remove residents from their facility. 

But facilities should take heed of some tips we have learned to better enable them to successfully remove these relatively few residents from their facility to improve operations and avert future liability.

We know that facilities have been anxious to increase census after COVID-19. What that can often lead to, however, is facilities taking on residents more freely without properly utilizing pre-admission screening techniques. Proper pre-admission screening can often help facilities avoid taking on disruptive residents or residents who will become a problem down the road.

Nonetheless, we are seeing more facilities shortcut the pre-admission processes, leading to the housing of more problematic residents, and, inevitably, leading to more involuntary transfer and discharge proceedings.

Depending on the state, involuntary discharge proceedings may seem easy and straightforward to unsuspecting facilities that may not have recently engaged in them lately. However, it is important to note that state departments of public health require more than just your word or assertion that the resident is causing problems, or that the resident is disruptive, or that the resident needs a higher level of care.  

State Administrative Law Judges (ALJs) are usually very pro-resident when it comes to these discharge proceedings. After all, why would they not be when a facility is actively trying to remove a resident from their “home.” That can lead to ALJs being skeptical of facilities during the hearing process. We often find that ALJs will try anything in their power to allow the resident to stay in their home.

One of those tactics is pointing out procedural flaws in the notice of involuntary discharge;  notices that must meticulously follow state laws and regulations. If there is a problem with the service of the notice, or timeframe, or even minor blanks in the notice, judges will utilize those procedural flaws to dismiss the hearing and allow the resident to stay in the home, often resulting in a new notice having to be provided and starting the cycle all over again.

Another tactic is that the judges will carefully scrutinize and require robust evidence leading to the discharge. Often, detailed written exhibits are necessary to file with the tribunal. Also, it is often important, for example, to elicit physician testimony in involuntary transfers addressing a need for a higher level of care, or inability to meet the resident’s needs. That testimony may point out dire problems, supported by detailed medical records, showing staff problems in treating the resident or behavioral problems causing disruption in the facility with other residents or staff, all provided through a meaningful physician’s perspective.  

Common provider pitfalls

Whatever the case, we find that clients who try to “go it alone” and just show up with administrator testimony at a hearing will lose the hearing. Remember: the ALJ involved will use any avenue they can to place roadblocks against the discharge of the resident. For example, an ALJ may ask whether the facility has tried various interventions first, or whether better care planning would help, or whether a second opinion would help. In essence they try to argue that the discharge is premature.  

Furthermore, just being disruptive in a facility is often not the legal standard in each state for involuntary transfers and discharges. A resident could exhibit a pattern of egregious behaviors or even abuse against staff or other residents but that may not be enough reason to transfer. Why?  Because there are an inordinate amount of interventions that an ALJ or opposing counsel for the resident, or even the ombudsman, could easily point to for the facility to “try” before discharging, and those proposed interventions could be enough at a hearing to have the involuntary transfer and discharge denied or delayed.

What facilities need to do is develop a coordinated case with counsel. Treat it like a real trial, with adequate numbers of witnesses, and even, as mentioned, medical director or attending physician testimony. After all, we find that ALJs feel more comfortable challenging administrator or nursing opinions and testimony, but they seldom question a physician’s testimony regarding a particular problem resident. If physicians are not available to testify at a hearing, facilities should consider utilizing detailed affidavits from the physician to help their case.

In all, providers need to be aware that more of these cases are coming to fruition these days, and it is better to be prepared than end up in an endless cycle of multiple notices of discharge that keep getting delayed or defeated by the ALJs.

Failure to follow these tips will have the effect of allowing the problem resident to stay in the facility and cause more problems, and increased liability for facilities. Taking the time to prepare exhibits, affidavits, medical records and multiple witnesses may seem like overkill to unsuspecting facilities, but they are necessary to properly complete an involuntary transfer and discharge of residents through the hearing process.

Neville M. Bilimoria is a partner in the Chicago office of the Health Law Practice Group and member of the Post-Acute Care And Senior Services Subgroup at Duane Morris LLP, as well as the Cannabis Law Practice at Duane Morris LLP; nmbilimoria@duanemorris.com.

The opinions expressed in McKnight’s Long-Term Care News guest submissions are the author’s and are not necessarily those of McKnight’s Long-Term Care News or its editors.

Have a column idea? See our submission guidelines here.

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HHS could open the door for more marijuana use in nursing homes https://www.mcknights.com/blogs/guest-columns/hhs-could-open-the-door-for-more-marijuana-use-in-nursing-homes/ Tue, 19 Sep 2023 17:49:15 +0000 https://www.mcknights.com/?p=139815 I have been touting the benefits of medical marijuana for nursing home/senior care residents for many years now.  As a cannabis attorney, as well, I have been immersed in the research and studies, showing how marijuana can benefit nursing home residents, just like any other drug our residents may take for their well-being.  

But the risks of utilizing marijuana in the nursing home, I’ve been stating, have been too great. Marijuana remains a Schedule I federally illegal controlled substance, and, as such, the Controlled Substances Act defines cannabis and its distinct cannabinoids as possessing “a high potential for abuse … no currently accepted medical use … [and] a lack of accepted safety for the use of the drug under medical supervision.” 

However, now that may be set to change, as recent developments last month indicate that the feds may be seriously contemplating moving marijuana from a Schedule I controlled substance to a Schedule III controlled substance, allowing it to perhaps one day be prescribed by physicians as with most other drugs.

In a groundbreaking measure, on Aug. 29, 2023, the US Department of Health and Human Services recommended to the Drug Enforcement Administration that marijuana be reclassified from a Schedule I controlled substance to a Schedule III controlled substance. Reclassification in this manner, should the DEA choose to follow it, could have profound implications on the use of marijuana in nursing homes, not to mention profound effects on marijuana medical research, tax and banking, and criminal enforcement.

Today, 38 states have passed legislation allowing some form of medical use of marijuana, and 23 states have legalized recreational use of marijuana. These state laws all conflict with the current federal law, which makes it unusual that all of these states have found therapeutic medical benefits from medical marijuana, but the feds have  still not changed their classification that marijuana has “no currently accepted medical use.” 

As you may know, the benefits of marijuana for seniors have been documented over the years, with one peer-reviewed journal posting an actual study in a New York nursing home with nursing home residents showing very favorable results. (I’m referring to this by Zachary Palace, MD and Dan Reingold: “Medical Cannabis in the Skilled Nursing Facility: A Novel Approach to Improving Symptom Management and Quality of Life,” The Journal of Post-Acute and Long-Term Care Medicine [January 2019].)

Today, given marijuana’s continued Schedule I classification, the risk of federal enforcement remains in the use and possession of marijuana, even in nursing homes. Many would take issue with that statement, especially given the pronouncements by various US Attorneys General that the feds would not seek to enforce the federal illegality in states that have state marijuana laws in effect.  Recognizing state legalization initiatives, since 2009, the federal government has limited its enforcement in states that have legalized or decriminalized marijuana possession and use. Even current US Attorney General Merrick Garland has intimated that the Justice Department generally will not prosecute marijuana offenses in states that have decriminalized marijuana and have appropriate regulatory schemes in place, though no formal policy has been promulgated.

However, while the federal government may choose to take “prosecutorial discretion” when enforcing federal marijuana laws in states that have a structure for medical or recreational use, the fact remains that the law remains on the books, and use of marijuana in nursing homes could subject individuals to prosecution as it remains, today, a federally illegal substance.  

But now, HHS has now finally realized, perhaps, what most state legislatures have realized: that perhaps there is a therapeutic/medical benefit to medical marijuana after all.  We will now have to see what develops in light of this key pronouncement by HHS, and whether the DEA will take action to reclassify marijuana as a Schedule III drug. 

A Schedule III drug reclassification would mean that the drug is characterized as having some potential for abuse, but also has some accepted medical uses. This development could signal a sea change in marijuana acceptance by the federal government going forward.  Reclassification of marijuana in this area could lead to more robust medical marijuana research and less taxation for cannabis growers and dispensaries, not to mention profound banking and criminal ramifications allowing cannabis use to further proliferate . . . yes, even into our nursing homes for the benefit of seniors. 

We’ll have to wait and see whether the legal risks of marijuana use in nursing homes will continue, or if they will be lifted as HHS’ recommendation is further considered. What’s happened so far indicates there’s been unprecedented movement, at least in some circles.

Neville M. Bilimoria is a partner in the Chicago office of the Health Law Practice Group and member of the Post-Acute Care And Senior Services Subgroup at Duane Morris LLP, as well as the Cannabis Law Practice at Duane Morris LLP; nmbilimoria@duanemorris.com.

The opinions expressed in McKnight’s Long-Term Care News guest submissions are the author’s and are not necessarily those of McKnight’s Long-Term Care News or its editors.

Have a column idea? See our submission guidelines here.

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AI’s ‘monumental breakthrough’ keeping an eye on your health https://www.mcknights.com/blogs/guest-columns/ais-monumental-breakthrough-keeping-an-eye-on-your-health/ Mon, 21 Aug 2023 16:00:00 +0000 https://www.mcknights.com/?p=138714 In this age of artificial intelligence, I have often spoken and written about new technologies and breakthroughs in healthcare that can be useful for nursing homes and all healthcare providers alike. But this one could be the mother of them all, and a glimpse of what can come regarding breakthroughs by AI in healthcare.  

I’ve spoken about how clinical data in healthcare is and has been harnessed every day for many years. That enormous amount of data can be used in a continuum of increasingly accurate and useful data technology models, starting with statistical categorization (with a machine identifying breast cancer on a mammogram), which increases with further data collection to predictive analytics, and then morphs into the holy grail of healthcare technology and the pinnacle use of healthcare data: machine learning or AI performing tasks of actual physicians into making diagnoses for better outcomes.

But a new breakthrough by Google and its CEO, Sundar Pichai, shows that the fruits of healthcare data analysis, and AI over time, are now coming true. Google has announced a possible AI development that can do a quick eye scan that can predict your risk of heart disease and potentially other medical conditions.

I have often talked about AI in nursing homes, and how in the future, we could hope to see that AI, by harnessing all of the data about an individual and comparing that data with other individuals, could predict things like heart attacks, or even when a resident may fall in a facility. That is quite intriguing for nursing homes and the future of AI, but it seems now the future is actually coming to fruition.

Google is refining the technology and its AI algorithm, and it could be released for practical use soon, the company said. The algorithm it developed could recognize the signs of cardiovascular disease and deliver a diagnosis within seconds, all from a patient’s retinal scan or photos. If and when the algorithm begins to operate independently, this could change the landscape of the use of the eye scan for disease detection and management. 

This AI technology has proven in the Journal of Nature Machine Intelligence to have an accuracy rate from 70% to 80% in detecting cardiovascular risk of a heart attack by identifying minute patterns in eye scans linked to cardiovascular disease. “AI can identify heart disease from an eye scan” appeared in the National Eye Institute in January of 2022.

In case that wasn’t enough, Google also discovered that retinal scans also can be used to identify a person’s sex or even their smoking status, all from a quick retinal scan.  

Clearly, this raises legal privacy issues for patients, as now more and more information about an individual can be used to tell a story about a patient just from a quick retinal scan. With HIPAA and privacy laws limiting use of biometric identifying information, and state laws like the Illinois Biometric Information Privacy Act limiting use of, among other things, retinal scans, we see the push and pull of privacy entering the AI proliferation game. 

On one hand, laws limit (somewhat) retinal scan use, and those limitations could now impair further AI growth and use of retinal health scan technology that could have the result of impeding medical breakthroughs. On the other hand, patients may have a need to foster such AI growth in the use of their retinal scans, for the betterment of medicine as a whole.

This real dichotomy, and scientific conundrum of adherence to privacy vs. advancements in technology with regard to retinal scans specifically, was recognized in a recent study by the Mayo Clinic.  “Retinal Scans and Data Sharing: The Privacy and Scientific Development Equilibrium” by Luis Filipe Nakayama MD, et al.,  appeared in Mayo Clinic Proceedings Digital Health, Vol. 1, Issue 2 (June 2023).

Whatever your position is on privacy, the AI breakthrough is monumental. AI in healthcare seems to be limitless, or at least has a strong positive future ahead, and Google’s new algorithm is evidence of that.

For now, we’ll have to keep an eye on this technology and see if it can be used to improve healthcare for all. 

Neville M. Bilimoria is a partner in the Chicago office of the Health Law Practice Group and member of the Post-Acute Care And Senior Services Subgroup at Duane Morris LLP; nmbilimoria@duanemorris.com.

The opinions expressed in McKnight’s Long-Term Care News guest submissions are the author’s and are not necessarily those of McKnight’s Long-Term Care News or its editors.

Have a column idea? See our submission guidelines here.

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AI is everywhere! Addressing the legal risks through contracting https://www.mcknights.com/blogs/guest-columns/ai-is-everywhere-addressing-the-legal-risks-through-contracting/ Fri, 21 Jul 2023 16:00:00 +0000 https://www.mcknights.com/?p=137428 You can’t look in the news or see social media posts each day without hearing about artificial intelligence in healthcare. In fact, the advancements in AI in healthcare are making leaps and bounds, seemingly with each day that goes by.  

But nursing homes and assisted living providers need to understand not just the benefits of how AI can improve quality of resident care and improved operations, but also the legal issues surrounding AI in your facility.

The advancements

More and more, facilities are gearing up for use of AI in long term care. This comment in the McKnight’s article “Rising AI and machine learning investments powering senior care advancements” back in early May sums it up well:

“AI is transforming all industries and healthcare is no exception,” said  Amber Schiada, Senior Director, Head of Americas Work Dynamics and Industries Research at JLL. “The impact of AI and [Machine Learning] on senior housing goes hand-in-hand with the impacts on the broader healthcare industry including for patients: better personalized care, medication tracking, and wellness tracking and for the business: improved data analysis, cost savings, and more efficient workplaces.”

For the growing problem of Alzheimer’s disease, one research team in Hong Kong developed an AI model that can use genetic information to predict a patient’s risks of developing Alzheimer’s before symptoms occur. Another researcher developed an AI method to screen seniors for mild cognitive impairment and early dementia by analyzing their voices. Pretty amazing advancements.  

But as with anything new, there can be problems and errors that go with the territory.  Some researchers have found there can be errors with AI that could result in reliability problems. But hopefully those gaps and errors will be fixed as advancements in AI continue to proliferate and advance. In any event, sound contracting with AI vendors is needed to protect the facility against liability through use of AI.  

AI and privacy

One of the biggest concerns that providers have with AI is privacy. With the use of so much data needed to empower AI, that massive amount of data concomitantly needs to be harnessed, and, more importantly, kept private and secure. That security may entail the need for more advanced technology to keep AI models and functions away from cyberattacks or even breaches. 

In contracting, it is best to really explore what a vendor can offer — beyond them just telling you they are HIPAA compliant. Facilities need to focus on AI vendors and their actual privacy and security compliance. While HIPAA will require a robust business associate agreement (BAA) as part of your AI contracting, that may not be enough to protect the facility.

After all, a BAA only complies with the letter of HIPAA regulations. What may be more important is finding out how well equipped an AI vendor is with their technology. This may require facilities to look behind standard BAAs: Do they have a HIPAA compliance plan? Do they have safeguards in place? Are they HIPAA certified? Do they have adequate cyber liability insurance to cover potential breaches?

Again, HIPAA does not require facilities to police or audit their business associates, but to avoid liability, a little homework into your vendors can go a long way. Do you know where the data comes from to power the AI, and do you know where it goes? Facilities need to make sure that service providers providing AI agree in their contracts to meet appropriate obligations to protect the confidentiality of data, and its use and dissemination. Furthermore, adequate indemnification provisions in contracts will be key in securing a safe AI partner that protects your facility from liability.  

AI and intellectual property

In addition to privacy, there are other intellectual property concerns that should be addressed in proper AI contracting. AI systems can often learn from a wide variety of data sources. Facilities need to make sure that service providers selling or licensing their AI product have the appropriate rights and consents to use data from all of these sources. For example, if an AI vendor does not have appropriate rights to use certain information, a facility could be liable for infringement or misappropriation from a third party. Making sure your contract addresses these intellectual property concerns is, therefore, important for facilities using AI technology.  

Where did my indemnification go?

Finally, when contracting for any type of healthcare technology, make sure you look for more than the mere words “indemnification” in your contracts. Oftentimes, the most important part of any AI or healthcare technology contract may not be the indemnification provisions themselves, but the “Limitation on Liability” provisions in the contract.

Sometimes vendors say they have indemnification in their contracts, but upon closer review, the limitations on liability strip the protection offered by indemnity provisions with broad carve-outs or small caps on liability that limit the AI vendor’s liability immensely. Make sure the service provider accepts the brunt of responsibility and liability under your contract to protect your facility.  

Taking heed of your AI contracts is important for the successful use of AI in your facility. Paying attention to the above issues, while a start, is just the beginning. Don’t be fooled by the glimmer of this fascinating AI technology at the expense of incurring potential liability under poorly drafted contracts.  

Neville M. Bilimoria is a partner in the Chicago office of the Health Law Practice Group and member of the Post-Acute Care And Senior Services Subgroup at Duane Morris LLP; nmbilimoria@duanemorris.com.

The opinions expressed in McKnight’s Long-Term Care News guest submissions are the author’s and are not necessarily those of McKnight’s Long-Term Care News or its editors.Have a column idea? See our submission guidelines here.

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Now that COVID is waning, time to focus on the things you ignored https://www.mcknights.com/blogs/guest-columns/now-that-covid-is-waning-time-to-focus-on-the-things-you-ignored/ Wed, 28 Jun 2023 10:00:00 +0000 https://www.mcknights.com/?p=136391 Now that the Public Health Emergency has ended, and COVID-19 is starting to become less of a burden in your facility, now might be a good time to focus on protecting your liability. 

Here are some things that you may have overlooked while valiantly battling on the frontlines of COVID at your facility over the last several years. 

Resident contracts

I tell clients that resident contracts need to be reviewed yearly by their attorneys. Why? Because there are often updates to the law that can help you avoid problems down the road in your resident contracting. Think of it as a way to keep you out of trouble, and prevent more costly litigation down the road. Also, there may be particular residents or circumstances that posed problems for your facility that can be discussed with your attorney, and that could be remediated through simple contract revisions.    

With everything going on in long-term care, this year, I am making the effort to remind clients to revise their contracts with an attorney to avoid liability in the future. Regular contract revision is sound, good risk management. One of the easiest ways to eliminate or reduce your liability is to revise and update your resident contracts. 

For example, the provision of arbitration agreements in your contracts is just one of many updates that need to be looked into with your resident contracts. Indeed, the law concerning arbitration agreements in nursing home contracts has changed over time, and several times over the last many years. Failure to have a robust, legally sound arbitration provision will only result in an arbitration clause that will be deemed unenforceable if challenged in court. 

Compliance & ethics program updates

Another item you may have neglected while on the COVID front lines are your compliance plans. Too many facilities have a draft compliance plan gathering dust on a shelf somewhere. Nothing could be worse for a facility. Why? 

Because if the government comes knocking and they see that you have a compliance plan on your shelf, but you haven’t followed it in practice or even implementation, that will often lead to higher fines and penalties because the government will see that you knew the importance of compliance plans, but you actively chose not to take the time to adhere or implement it properly. 

Instead, focus on making sure you reinvigorate your compliance committee if you haven’t been having regular and documented compliance meetings over the pandemic. Also, now is a good time to have your compliance plan reviewed by competent healthcare counsel to ensure you take full advantage of the protections compliance plans can offer not only to your facility but also to the administrator, executive director, CEO and the rest of your management team. 

Over the years, I have found that often having an attorney sit in on a compliance committee meeting can help to guide effective compliance plan implementation. And remember, documentation and follow-up are always key. Corporate compliance plan implementation does not have to be daunting, it just needs to be done, and done right. 

HIPAA compliance

It is never a bad time to retrain and update your staff on HIPAA privacy and security compliance. Whether it is conducting regular privacy and security meetings or instituting your HIPAA-required Security Risk Assessment, doing these things now can help avoid major fines and penalties in the future for noncompliance. 

Furthermore, attention to privacy and security can help to avoid the number one problem we see in HIPAA noncompliance and exorbitant fines and settlements for violations of HIPAA: human error. Re-educating your staff and updating your policies can have a dramatic effect on not only avoiding human error, the number one cause of HIPAA breaches, but it also can help improve your operations. 

In fact, each of the above three things you may have ignored over the COVID-19 pandemic are all there to help improve your operations. Yes, risk management is also a key output of updating and implementing these initiatives, but if you do so, your facility will also find improved operations, which is key, and the lifeblood of any well-run facility these days. 

Neville M. Bilimoria is a partner in the Chicago office of the Health Law Practice Group and member of the Post-Acute Care And Senior Services Subgroup at Duane Morris LLP; nmbilimoria@duanemorris.com.

The opinions expressed in McKnight’s Long-Term Care News guest submissions are the author’s and are not necessarily those of McKnight’s Long-Term Care News or its editors.

Have a column idea? See our submission guidelines here.

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Telehealth and therapy services: Let’s keep it going! https://www.mcknights.com/blogs/guest-columns/telehealth-and-therapy-services-lets-keep-it-going/ Fri, 19 May 2023 16:00:00 +0000 https://www.mcknights.com/?p=135229 It’s pretty simple, really. Telehealth in physical, occupational and speech therapy allows more treatment for seniors, and better access. 

By reducing travel times for therapists between facilities, therapists are allowed to treat more seniors, in different buildings, and faster. With therapists and staffing all around being reduced in long-term care nationwide after the pandemic, telehealth in long-term care makes great sense.

But the Centers for Medicare & Medicaid Services is considering what’s next for therapy and telehealth. With the end of the public health emergency for COVID-19 last week (May 11), seniors’ access to telehealth therapy is in danger. 

The Consolidated Appropriations Act of 2023 directed CMS to extend beneficiary access to therapy delivered via telehealth through Dec. 31, 2024. But if nursing homes and assisted living facilities go back to the now seemingly antiquated way of providing therapy for residents — in person vs. telehealth — CMS will greatly limit access for seniors, a result that can be easily avoided with new rules that providers are waiting for from the agency. 

But the future is uncertain. CMS “seems” ready to extend telehealth for therapy services, but exactly how remains to be seen. In recent guidance published May 10, 2023, CMS briefly discussed therapy without revealing specifics for telehealth:

“After the PHE ends, we will resume consideration of changes to the Medicare Telehealth Services List exclusively through notice and comment rulemaking. To reduce exposure risk, during the PHE and for an extended period of time for many services, the following have been added to the Medicare Telehealth Services List:  . . . 

•  Therapy Services, Physical and Occupational Therapy, All levels”

Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19,” Centers for Medicare & Medicaid Services

CMS will be coming out with its new rules for telehealth and therapy, but until then, the future of telehealth and therapy is uncertain. In reality, it is a mystery why telehealth in this country is so frowned upon by regulators.  

Back in the day, when technology wasn’t what it is today, perhaps regulators had some good reasons to be skeptical of telehealth. But what has happened since then is truly amazing.  

The pandemic forced providers to provide new ways of healthcare, and telehealth was thrust upon the public in a way that patients and residents never experienced before. And guess what?  Patients and staff loved it — they received needed access to care, all in the comfort of their own homes.

Bottom-line: This forced method of telehealth was a huge help to seniors in nursing homes, not to mention patients nationwide who decided to use telehealth for the first time in order to receive needed healthcare.

But if staffing shortages continue post pandemic, even though the public health emergency is over, why not make telehealth a real part of the everyday fabric of medicine and especially geriatric care? If access is a problem in long-term care due to staffing shortages, why not solve the problem with telehealth, and embrace it going forward?

What we learned about telehealth and therapy from the pandemic is significant. According to Scott Wilson, president of Elevate Therapy Consulting Group, the pandemic only highlighted problems in staffing, and showed the real benefits of telehealth in therapy at the same time:

“In my view, the greatest asset to telehealth is the ability of therapists to get care initiated quickly, especially in the underserved and rural areas. Oftentimes, you will see therapy extenders (PTA’s and COTA’s) in the facilities waiting for a higher licensed therapist to perform the evaluation. Telehealth expedites that initial evaluation and allows treatments for the resident to occur quickly. We are talking two to three days quicker, and oftentimes longer, due to staffing challenges in today’s market.”  

But the impetus for telehealth and therapy does not end with the immense access and improved services benefit to geriatric patients and residents everywhere. Don’t forget about the therapists.  According to the National Association of Rehab Providers & Agencies representing more than 80,000 therapists, rehab providers and rehab support organizations, including inpatient and adult living and skilled nursing facilities, one main benefit of telehealth for therapy services is the elimination of a common problem: therapist burnout.  

According to NARA, in 2021 alone about 22,032 physical therapists have left the workforce, and the demand for physical therapy is only expected to grow over the next 10 years. 

Why did they leave? Stress!  

According to NARA: “Another large reason why there is a physical therapist shortage is many physical therapists are experiencing burnout. Burnout in physical therapists has increased due to long hours and constantly changing hours. Many physical therapists have chosen to either quit their profession altogether or switch to part-time positions. With the added stress within the industry post-pandemic, many professionals find it hard to establish a good work-life balance and struggle to stay motivated to continue with this practice.” 

So not only will the proliferation of telehealth therapy services provide greater access to seniors, especially in rural areas, going forward. It also will help therapists ease stress. 

 Among other solutions for the therapy staffing shortage that NARA suggests, there’s this: telehealth can help relieve therapist burnout, and get therapists back into the workforce.

Neville M. Bilimoria is a partner in the Chicago office of the Health Law Practice Group and member of the Post-Acute Care And Senior Services Subgroup at Duane Morris LLP; nmbilimoria@duanemorris.com.

The opinions expressed in McKnight’s Long-Term Care News guest submissions are the author’s and are not necessarily those of McKnight’s Long-Term Care News or its editors.

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Relaxed enforcement for telehealth is over https://www.mcknights.com/blogs/guest-columns/relaxed-enforcement-for-telehealth-is-over/ Wed, 19 Apr 2023 18:52:08 +0000 https://www.mcknights.com/?p=134109 Well, we knew it might happen sometime.  We saw the silver lining of COVID-19 these past few years in the form of relaxed rules by the government to allow for the easier implementation and proliferation of telehealth to help with the pandemic.  

But on April 11, the U.S. Department of Health and Human Services and its Office for Civil Rights announced that those previous notifications regarding relaxed HIPAA enforcement that, in part, supported telehealth use during the pandemic, are now being revoked on May 11 due to the expiration of the COVID-19 Public Health Emergency (PHE).  

That means providers have 90 days (from May 12, 2023, to Aug. 9, 2023) to come back into compliance with all HIPAA rules despite the use of relaxed telehealth measures over the last three years. Let’s break this down a bit.

Previously, on March 17, 2020, OCR decided to affirmatively loosen HIPAA enforcement amidst the COVID-19 pandemic:

We are empowering medical providers to serve patients wherever they are during this national public health emergency. We are especially concerned about reaching those most at risk, including older persons and persons with disabilities. 

That was from Roger Severino, OCR Director in a March 17, 2020 news release, “OCR Announces Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency.”

Also on March 17, 2020, OCR/HHS announced and officially published its HIPAA enforcement discretion, effective March 17, 2020, waiving all potential penalties for HIPAA violations against covered entities that serve patients through telehealth communications technologies in an effort, presumably, to foster remote video communication products and telehealth services to patients during the COVID-19 pandemic. 

This waiver of penalties and sanctions applied to all covered entities, including nursing homes.  That meant that skilled nursing facilities could have physicians (who were unwilling to come into a facility for fear of COVID-19) to provide telehealth remotely at the resident’s bedside using modalities such as Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype. Gone was the need for ultra-secure, HIPAA-compliant telemedicine feeds that were a barrier to the proliferation of telemedicine in nursing homes in the past.  Residents were able to use simple FaceTime and receive the care they needed at the bedside remotely.

Surprisingly, this OCR telehealth waiver applied not only to telehealth services provided to treat patients or residents related to COVID-19, but also to ALL telehealth provided by covered entities for any reason during the COVID-19 public health emergency.  So since that March 17, 2020, announcement, nursing homes and other covered entities have been free to provide telehealth without risk that OCR might seek to impose a penalty for noncompliance with the HIPAA Rules related to the good faith provision of telehealth during the COVID-19 nationwide PHE. This relaxation of rules was a boon to telehealth implementation, and patients and residents loved it, resulting in greater access and efficiency of care through telehealth over the pandemic.  

But all good things come to an end. Now, facilities have to ramp up and make sure their telehealth devices and modalities used during the pandemic are back up and fully secure and compliant with HIPAA.

That means no more unsecure video chats, video modalities, social media or Face Time can be utilized for purposes of telehealth unless they follow the strict HIPAA Privacy and Security Rules. And facilities have until Aug. 9, 2023 to get back in compliance.   

This means that nursing homes will no longer be able to utilize unsecure iPads, smart phones or other technology for telehealth services unless they meet the stringent HIPAA patient privacy and security requirements after Aug. 9, 2023.  This will require nursing homes to evaluate their current telehealth modalities used in the facility, and review current uses of telehealth with vendors, physicians, hospitals and other providers. 

Then facilities must update their agreements, policies and procedures, and software technology itself in order to ensure compliance with HIPAA Privacy and Security Rules. Providers are encouraged to start this process as soon as possible to avoid fines and penalties by OCR after Aug. 9. 

Neville M. Bilimoria is a partner in the Chicago office of the Health Law Practice Group and member of the Post-Acute Care And Senior Services Subgroup at Duane Morris LLP; nmbilimoria@duanemorris.com.

The opinions expressed in McKnight’s Long-Term Care News guest submissions are the author’s and are not necessarily those of McKnight’s Long-Term Care News or its editors.

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Bad survey? Call your medical director https://www.mcknights.com/blogs/guest-columns/bad-survey-call-your-medical-director/ Mon, 20 Mar 2023 16:00:00 +0000 https://www.mcknights.com/?p=133001 I recently won a case against state surveyors and I learned something new… again. 

The surveyors were adamant that the facility neglected a resident, and cited violations of policies, and criticized the nursing care afforded to the resident who later passed away. The surveyors cited harsh penalties against the facility. 

We requested a hearing to contest the surveyor findings and after two years of negotiating, the department refused to budge on the fines and penalties. So it was time to take this one to hearing.

The facility was adamant that their care and treatment of the resident was not neglectful, that they did follow their procedures, and that the nursing care was adequately provided at all times to this beloved resident. We provided arguments that were reasonable, supported by good nursing practices, and records to show compliance. The department didn’t budge.

At the end of the day, after reaching impasses, we prepared the case for hearing before an administrative law judge. Shortly before the hearing, we had to provide our list of witnesses.  Ingeniously, our list of witnesses included a renowned physician expert, and a renowned nursing expert. The department had no expert witnesses. They wanted to rely on their nurse surveyor and testimony of employees during the survey, despite the fact that we showed the employee statements were inaccurate, supported by our good nursing and medical evidence.

In the days before trial, something happened. The department got nervous. After all, the department had no experts and we had two. Each day that passed, a new offer of settlement came and we rejected the paltry offers, claiming that the facility should be vindicated from the harsh penalties the department was so adamant to initially enforce.  

Finally, on the eve of trial, the department caved and relented, deleting the key tags and reducing the fine substantially. In fact, it was everything we had initially requested to settle the case two years before, and more. A huge victory for the facility.

I tell you this story not to brag, but to show you that sometimes nursing surveyors need a nudge.  They think they are correct until someone can prove they are not. That someone usually comes in the form of a physician expert. After all, physicians oversee resident care and nurses react and respond to physician orders every day. Only after we revealed the threat of a physician expert who could discount the nursing surveyor findings did the department surrender.  

That’s what these cases come down to these days. So often when we have a bad survey at a facility, we need to focus on the experts. Providing an informal dispute resolution or contesting a survey can be difficult, but it’s necessary to stop bad surveyor surveys and erroneous findings.

Perhaps getting the medical director more involved in fighting the survey from the start may tip the scales in favor of a better settlement and quicker outcome for facilities. Whether it is consultation of the medical director regarding the survey, or obtaining even a well-drafted legal affidavit of the medical director to support care given, having the physician expert there may be the only thing that convinces surveyors and state health departments of wrongfully cited deficiencies or violations.  

Surveys are on the rise, and enforcement is stepped up these days for facilities. Having your medical director help with deficiencies, or even having your attorney speak to the medical director early on to support a facility’s good care, may be the ticket to quick resolution of cases. 

These cases can take time, but in the end, medicine controls, good nursing care controls. Talking to and utilizing your medical director up front, and more often, about these surveys and surveyor findings can help to better resolve these surveys more efficiently.  

Neville M. Bilimoria is a partner in the Chicago office of the Health Law Practice Group and member of the Post-Acute Care And Senior Services Subgroup at Duane Morris LLP; nmbilimoria@duanemorris.com.

The opinions expressed in McKnight’s Long-Term Care News guest submissions are the author’s and are not necessarily those of McKnight’s Long-Term Care News or its editors.

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