AHLA's Speaking of Health Law

AHLA’s Opioid Podcast Series: Hospital Perspective

June 20, 2018 AHLA Podcasts
AHLA's Speaking of Health Law
AHLA’s Opioid Podcast Series: Hospital Perspective
Show Notes Transcript

Hospitals, physicians, and pharmacies are on the front lines of the opioid crisis. AHLA’s Opioid Podcast Series explores the critical legal and operational issues related to the opioid epidemic from each of these perspectives and offers expert insight for addressing them. This podcast features the perspective of hospitals.

To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.

Speaker 1:

Hello, my name is Ellie Bain. I'm the Vice President publications of the A H L A Public Health Systems Affinity Group. We are recording this podcast as part of a series on legal issues regarding the opioid crisis. This podcast focuses on legal issues facing hospitals as they deal with the opioid crisis. I have Melissa Jank and Olivia Serafim with me. Melissa is a member of the New York office of Epstein Becker Green in the healthcare and life sciences and litigation practices. Ms. Jan represents healthcare organizations, including healthcare systems, physician group practices, pharmacies and other healthcare providers, and their officers and directors in a variety of enforcement matters at both the state and federal levels. Olivia is an associate in the healthcare and life science practice in the Washington DC office of Epstein Becker Green, focusing on the healthcare industry. Olivia and Melissa are co-authors of the article on cutting edge hospital legal and regulatory issues related to the opioid crisis, which you can find in the may issue of the Connections Magazine. Thank you both for joining me today. We are going to begin by talking a little bit about the article, uh, that Melissa and Olivia wrote The article identified a unique program in New York as part of a delivery system reform incentive payment program. Um, that program sounded really interesting. Can you guys elaborate a little bit on that program?

Speaker 2:

Of course. And, um, this is Olivia and, uh, I'll be taking this question. Uh, so the New York, uh, delivery system Reform Incentive payment program is a really great example, a state innovation to not only address the opioid crisis, but also just to restructure the healthcare system overall. Um, the delivery system Reform incentive payment program is part of the Medicaid waiver amendment, which is an agreement by which New York state is reinvesting 8 billion in federal savings back into its Medicaid program. And it's doing this through a variety of different groups, one of which we discussed in our article, which was the State Island Performing Provider System. And it's one of 25 different groups working as part of this New York, uh, delivery system program. And the Staten Island PPS is actually a network of over 70 partners, which includes skilled nursing facilities, behavioral health providers, home healthcare agencies, um, and a wide range of different community-based clinical facilities. Um, and within that network, they're currently implementing over 11 different programs. And these are focusing on integrating primary care and behavioral health, which is increasing screening and, uh, incorporating more medical assessments into patients practices to ensure that they're coordinating care of services, uh, for different patients. Um, they're also implementing different withdrawal management programs, um, that include developing a detox service for substance use disorders within community-based addiction treatment programs, um, to provide medical supervision and allow, um, for the transfer stabilized patients into different substance use disorder services. Um, this is just one example of a way that the state is giving greater payment flexibility to groups to try to innovatively address the opioid crisis. And, um, it's definitely something that we should look out for.

Speaker 1:

That sounds really interesting. Do you think that other states will implement similar measures or have you heard of any other similar measures being implemented across any other jurisdictions?

Speaker 3:

Hi, this is Melissa. I'm gonna address that question. Um, what we're seeing is that there's innovation at all levels, uh, both federal, state and local levels, and even at the sub micro level to address the opioid crisis right now. And, um, the New York State program is one example of the state innovation, but there's certainly a lot of other innovation that is going on through, you know, different, different kind of innovations. So whereas we, we don't see anything directly tied as saying we're modeling an after Staten Island. We, we have seen a lot of creativity out there as people try to find out what's the best way to respond to this epidemic that's really hit this country very hard

Speaker 1:

Because there is so much innovation and the opioid crisis is really growing day by day in new and different ways. Um, you know, there's so many different legal issues that come up, uh, from a hospital perspective. Is there anything that you can think of now in terms of policies, procedures, or trainings that you think, uh, hospital clients should either implement or should consider and work on implementing now even before the state might require it?

Speaker 3:

Well, we definitely would recommend for hospital systems to be proactive in their response and by nature of the fact that they're really bearing the brunt of the opioid crisis in terms of responding to people who are overdosing and having issues with, with opioids or side effects or things like that, that they're being particularly hard. I mean, you have to think about where we came from since 1999, the number of prescription opioid overdoses in the United States have quadrupled, um, which is just an incredible number. And that's particularly heading hospital systems hard. And you also have to think about the fact that statistics indicate that 80% of heroin addiction starts with prescription drug addiction. So we, we have this sort of duality between drugs that you can obtain through medical providers and the prescription drug addiction, and then the corollary search for, um, for opioids, which often lead to users trying heroin and then entering into that sort of world of, of a legal drug, um, in, in consuming illegal drugs. So in terms of answering your question about it, if there's any policies or procedures or trainings that we re that we recommend that hospitals think about, um, we of course recommend that hospitals establish a strong regulatory compliance program in place to monitor the changing state and federal laws and the changing expectation and obligation of hospitals, which of course is easier said than done. We all know how difficult it is to keep up with that on top of all of the other regulatory requirements that that hospitals have. But given that the landscape is really changing, we, we do recommend that. We also recommend that hospitals proactively improve tools for pain care providers, including training and resources for assessing, diagnosing, preventing treating and managing acute or chronic pain, and providing training to providers on detecting the early warning signs of opioid use disorders. Now, some of that is being mandated from above by state and local authorities and, and the even federal authorities are contemplating this, but to be proactive in that space certainly can make hospital providers stay a step ahead. Um, tied into that is the idea of a hospital and provider systems developing new pain management protocols to try to standardize postoperative pain regimens in order to limit the amount of narcotics given to patients. And we see a real movement across the country to, um, superimpose regulatory requirements on providers in terms and restrictions on, on providers in terms of how many, um, opioids are allowed to prescribe at one time. Um, how many refills if there are refills. Um, and that is, we're really seeing a mosaic of responses nationwide in response to that. But certainly, um, hospitals should also consider what we know the federal government is proactively doing, which is using data analytics. And we would encourage hospitals to use prescription drug monitoring programs to see where there's outliers, to see who within their hospital systems are prescribing the most and to see if there's alternatives to opioids. And, you know, this is a really difficult issue, one that we've spent a lot of time with, with providers that, that we advise on a regular basis talking to them about, because we can't forget that there are people in pain and that there are people who are actually helped through the use of opioids. And to balance the pain management issue with the over-prescribing potentials is

Speaker 1:

Really, really a delicate balance. Yes, definitely. Thank you. I think that's really helpful. Um, one of the things that I think as, as hospital counsel, um, folks are concerned about with the opioid epidemic is the ability to share patient information. Can you discuss the ability for hospitals to share patient information when a patient has been admitted for a drug overdose?

Speaker 2:

So as you said, this is an extremely important question and definitely a concern. Hospitals, uh, should think about when, um, they're Dealing with, uh, overdose patient overdose information and you know what to do with that. Um, a lot of the programs that we're hearing coming from both federal and state governments talk about using and sharing data for, um, not only identifying and treating patients at a high risk for drug abuse, um, but also as Melissa mentioned for enforcement purposes. Um, unfortunately it gets complicated when you also have to consider varying federal and even state standards that are protecting patient information and may actually, um, infringe on the ability to share information as widely as, um, as we may want. For example, HHS recently published the guidance discussing certain limited circumstances for HIPAA would allow provider when dealing with a patient, um, in an overdose to share that patient's information without his or her consent with their family members or even close friends. Um, now, although the guidance is, seems to be well-intentioned, it unfortunately really only applies to a really small subject of providers. Um, in fact, when we're talking about the opioid crisis, we really have to talk about the applicability of the federal regulation 42 CFR part two. Um, in addition to talking about the HIPAA requirements, 42 CFR is important because it applies to the broad umbrella of facilities that qualify as a federally assisted drug abuse program. And this includes treatment programs, rehabilitation programs, and even emergency rooms that hold themselves out to their community as providing, um, substance use disorder treatments, um, or even that refer patients to treatments. And, um, the difference or the important part about 42 CFR part two is that it really does not allow for the sharing of patient information without the patient's consent, um, except for the limited purpose of providing treatment. So that aligns with hipaa, but hospitals that are subject to this 42 CFR part two requirements are not going to be able to abide by the guidance, which says they can share information with a patient's, uh, friends or family members. They really can only share the information with, uh, with the patient's consent and even then only with other providers. Um, now an important exception to, uh, both HIP and 40 CFR part two is this idea of treatment. So for treatment purpose, they can share, um, patient information with other providers. Uh, an important exception to 42 CFR part two, that also applies in the case of dealing with an opioid overdose, of course, is the exception from medical emergencies. Um, so in a medical emergency, 42 CFR part two does allow for the sharing of patient information, um, however the, the medical emergency needs to be properly documented. And so hospitals need to make sure that they're really documenting who is sharing the information with whom it's being shared and the type of medical emergency to make sure they're complying with 42 CFR part two. Um, so it's really complicated, um, and it gets further convoluted when hospitals really have to consider changing state law as well because HIPAA actually requires hospitals to, um, adhere to the most stringent requirements for protecting patient information. So even, um, you know, with everything that HIPAA and 42 CFR per two put on hospitals to protect the patient information, hospitals also have to monitor state law to see, um, if there's different requirements that might be more stringent and might, uh, further constraint the ability to share information.

Speaker 1:

Olivia, that sounds really complicated to figure out what are some best practices that, um, hospitals can create or can use regarding the sharing of information, um, for opioid or drug users, abusers and seekers?

Speaker 2:

Yes, so it's, it is complicated. Um, and that's why, you know, we really recommend, uh, that hospitals, uh, get to the practice of really carefully monitoring state privacy laws. Um, they're frequently changing. Um, they're trying to adjust, you know, as I mentioned, the, a lot of these programs have the goal of, you know, using data in a positive way. Um, so privacy law laws, privacy laws are changing. And, um, we really encourage hospitals to carefully monitor those laws. Um, another best practice that hospitals can uh, adopt and that Melissa touched upon is really ensuring property utilization of EHRs and prescription drug monitoring programs, uh, as well as treating physicians on how to best leverage them. Um, the more prescribers that use this PDMP information, the better the collective care of patients, um, will be. And, um, it's really an important step in addressing the opioid crisis. As I mentioned, there's a lot going on right now on the hill as well. Um, for instance, the Opioid Crisis Response Act of 2018, um, currently includes some provisions that are encouraged ACE to share PD and P data with one another. So that further helps the ability of providers to work together to really address the opioid crisis. Um, and that's something that hospitals should monitor as well.

Speaker 1:

Well, that sounds very promising. I think that would be really helpful to coordinate efforts. Speaking of coordination, if a city had several hospitals, what are some ways that you can think of that they might be able to work together to address the opioid crisis? Um, in terms of, is there a way to share patient information or best practices? Um, what are some thoughts that you guys might have?

Speaker 3:

So with res regard to sharing patient information, it really turns on the specifics of the situation. Um, sort of going back to what Olivia was just talking about, is it for treatment purposes only, has a patient consented? Um, so it very much depends on the factual scenario, and it's gonna be guided by, in large part state laws, which could impact the ability to share information in addition to the federal statutes that Olivia was just referring to. Baltimore is doing a very innovative program, which is worth, uh, highlighting here, um, where it is encouraging hospitals within the city of Baltimore to work together in addressing the opioid crisis. The city of Baltimore and all this, 11 hospitals have agreed to a new city initiative aimed at increasing their role in fighting the opioid epidemic by focusing primarily on developing potential standards of care that hospitals must follow when treating people with substance abuse problems so that people who are opioid addicts will, will get si similar kind of treatment no matter which facility they go to, which may cut down on hospital shopping, things like that. The initiative would also better track what hospitals are doing and look at how they can do more by sharing what has worked with their hospital peers. So it, it, it doesn't get into the weeds in terms of the, some of the privacy issues that we were discussing earlier, but focuses a lot on best practices and sharing of resources and pulling resources with similar patient populations. Additionally, the city of Baltimore's opened a 24 hour stabilization center that serves as a safe space where drug users can go when they're intoxicated to receive medical treatment and links of social services, which is quite in innovative.

Speaker 1:

Yeah, that, that sounds great. Um, uh, it'll be interesting to see how that program works and maybe if it can be scaled out to other cities. So I'm gonna ask both of you, um, another question that may difficult to answer. What do you think is the greatest challenge facing hospitals in dealing with the opioid crisis?

Speaker 3:

Um, this is something that Olivia and I spent a while discussing before, uh, when we were getting ready to prepare for this podcast. Um, and there's sort of, uh, four different areas that we see in terms of the greatest challenge. Um, one is something I alluded to earlier in the podcast, which is effectively treating patients without opioids, while still attempting to reduce rates of readmission, maintain patient satisfaction and quality of life, and decrease pain response. Um, so, you know, there are some conditions that are difficult to manage without opioids, and one of the reasons opioids are so addicting is that they are effective for many people and reducing pain. Um, so it, it does put the provider in a difficult position if they know that they can, um, improve somebody's quality of life by prescribing opioids to them. Um, but there's all this pressure to, to not prescribe opioids that is sort of gathering steam within the country, uh, within our country. Excuse me. Um, second of all is dealing with the financial impacts of the opioid crisis. Um, hospitals are spending large amounts of resources and money treating patients coming to, into hospitals with complication complications related to opioid abuse. And, um, in fact, one study in West Virginia found that a West Virginia hospital billed 17.3 million to care for patients requiring care and surgery for o opioid related infections. And that hospital was only reimbursed for$3.8 million. So it puts a real financial strain on the providers. Um, and as is a theme in our podcast today, the next challenge that we see is keeping up with the changing regulatory landscape, um, which imposes varying and different and constantly changing obligations on hospitals and providers, um, and used to you state in local regulations. And then finally, I would just also add that there's in, in changing enforcement regime, um, we see increased enforcement through both civil and criminal attempts. Um, we see civil suits against providers, against, um, individual providers. We see criminal convictions against providers for opioid prescribing. Uh, we see a state of addiction treatment centers that have settled allegations of unlicensed prescribing or on violations of the False Claims Act. There was recently a, uh, an individual who owned a series of sober homes and in South Florida in the southern district of Florida, who was sentenced to 27 years for Medicare and Medicaid fraud, um, in a criminal prosecution of seven individuals connected with those homes. So we really do see a very strong enforcement environment that's specifically targeted on, uh, the opioid sector, on treatment of opioids. In fact, my old office, the United States Attorney's Office for the District of New Jersey recently reorganized under the new US attorney who took over and, um, has a separate opioid enforcement unit that's different from the longstanding narcotics prosecution unit. So we see, we, and we see that happening nationally, is, is designated prosecutors for opioid cases.

Speaker 1:

Very interesting. I did not know that. Um, but I do think it's indicative of this crisis and the multiple legal issues that essentially the greatest legal, the greatest challenge is, is a fourfold challenge. So, um, you know, for for hospital counsel that aren't prepared, I, I would definitely direct them at least to start with your article and then to follow up on some of these, um, references. Um, I wonder if, and I, and it may be four things, but what is the one thing that you think is most important to remember when advising hospital clients on ways to deal to get their hounds around the opioid crisis?

Speaker 3:

Olivia, I'm gonna let you take this one,<laugh>.

Speaker 2:

So, um, Melissa and I also spoke about this and really, uh, what we want to, um, impart on hospital clients is really that hospitals need to be part of the long-term pollution to the opioid crisis. Um, as Melissa mentioned, you know, a lot of heroin addiction stems from prescription pill addiction first. And, um, so hospitals really need to think of themselves as part of the solution to the opioid crisis and not just, um, you know, responding to the crisis. Hospitals as part of the healthcare system in general, need to look long term, how they can change the way pain is treated, how, um, how mental health is treated. There's no really, there's no short term solutions to the opioid crisis. And so there really needs to be an institutional change in the way that patients are cared for. And one very important, uh, point to start at is within the hospitals.

Speaker 1:

That's good advice. Um, before we close up, uh, or wrap up today, Olivia and Melissa, is there anything that we didn't talk about or we didn't address that you think is important to remember? Uh, especially for hospital clients dealing with the crisis?

Speaker 3:

Um, I would just say that in terms of the, on the enforcement side, some people might not realize that we've seen OIG using its exclusion authority in this space. And we've certainly seen state attempts as well, um, to go after providers who are, um, convicted of crimes related to the provisions of services, um, and in the opioid crisis. So this, this is an area that I think we're seeing increasing focus on. Um, one of the sort of bellwether areas that those of us in the enforcement arena look at is the healthcare fraud takedown that's done by the Department of Justice, traditionally in June or July of each year. And last year for the first time the Department of Justice included opioid related cases as part of their overall numbers and their overall takedown. And so we really are seeing an extension of these opioid enforcement efforts being done, not only at the criminal level, but certainly through civil false claims Act, through civil fraud cases, as well as on the administrative side.

Speaker 1:

Melissa and Olivia, on behalf of the hla, um, I wanna thank you so much both for your article and for your time today. I know as hospital counsel, I learned a lot. Some of it was frankly a little scary, um, but it was very informative. Um, thank you so much, yours and your perspective, um, volunteering to be on the podcast today.