Speaker 1 (00:05):

Welcome to Hospitals In Focus from the Federation of American Hospitals. Here’s your host, Chip Kahn.

Chip Kahn (00:15):

On Friday, June 24th, The Supreme Court overturned Roe versus Wade. The court’s decision is far reaching, with many complex consequences. There has been much discussion about how the court’s action and resulting newly operative state abortion restrictions impacts the offering of abortion and reproductive services in many states, with clinics and services being shuttered. But we are just starting to unwrap the effects on hospitals and clinicians treating severely ill women who will be facing new questions about the conditions under which essential services are to be provided. There are many aspects of care within the hospital that are now going to be viewed in a new light, considering the whirlwind this decision has unleashed.

Chip Kahn (01:06):

Today we’re going to concentrate initially on potential issues raised for emergency care and other services for extremely sick women. Our discussion today with Tom Barker will highlight issues of concern. It is not our intention to value judge here or take specific policy positions, but in a very real sense to contribute to discussions that will have to take place so hospitals and clinicians who care for very sick pregnant women will know how to comply with the state laws or local regulations in certain jurisdictions, as well as do the care they’re there to provide.

Chip Kahn (01:47):

Our guest is Tom Barker, a partner at Foley Hoag who focuses his practice on complex federal and state, health care legal and regulatory matters. Tom has an enviable resume. Among his experience, most notable for our discussion today, prior to joining Foley Hoag, he was acting general counsel of the U.S. Department of Health and Human Services and general counsel of the Centers for Medicare and Medicaid Services, otherwise known as CMS. Tom, thanks so much for joining us today.

Tom Barker (02:21):

Chip, thanks so much for the invitation. I’m really happy to be here.

Chip Kahn (02:25):

So let’s get started and maybe start at the 30,000 foot level. What’s the significance of this Supreme Court decision for hospitals and clinicians who have an obligation to care for all the women who come through our doors?

Tom Barker (02:39):

Well, I think to begin with, there are a couple of federal statutes at play, also some state law concerns. The first is just that there is a common law duty of care. Hospitals have an obligation, depending upon the state, under common law to treat anyone who comes through their doors. There are the Medicare conditions of participation and the provider agreement that hospitals sign with CMS in order to participate in the Medicare and Medicaid programs. The statute that authorizes that provider agreement says that providers have to act “in the interests of the health and safety of individuals furnished care at the facilities.” In fact, the Supreme Court cited that very statutory provision in upholding the vaccine mandate earlier this year.

Tom Barker (03:31):

There are also potential state law requirements and, of course, hospitals need to be concerned about negligence liability under state law. So in response to your question, Chip, I think there are several legal principles at play that are going to come up as a result of the decision in the Dobbs case.

Chip Kahn (03:51):

It’ll be hard to cover the entire map of federal requirements, but why don’t we drill down on one specific that is so much a presence in emergency rooms and how hospitals and clinicians approach emergency care, and that’s EMTALA, which in a sense requires us to provide the services when somebody is brought into the emergency room. The origin of the law, which goes back to the 1980s, actually was to solve problems that arose regarding pregnant women coming to the emergency room and not being provided services or being sent to other facilities. Can you talk about EMTALA and the implications of the EMTALA requirements for women coming in and presenting with situations that could be covered by these new laws that states have that are going into effect regarding abortion?

Tom Barker (04:48):

Yeah, that’s a great question, Chip, and I’m happy to talk about that. As you pointed out, EMTALA was enacted in the mid 1980s in large part due to concerns that were aired in congressional hearings about individuals who came to hospital emergency departments, facing an emergency medical condition that might have been turned away. EMTALA imposes three obligations on hospitals. Number one, any individual who comes to the emergency department is entitled to a screening to determine whether or not the patient has a medical emergency. Second of all, if the patient has a medical emergency, they’re entitled to be stabilized, or if the medical benefits outweigh the risks to be transferred to a facility that has capabilities to treat the individuals. So those three requirements; screening, stabilization and appropriate transfer are all relevant. When Congress wrote the EMTALA statute, they specifically highlighted that a pregnant woman, a woman in labor, a woman having contractions met the definition of a medical emergency and therefore was entitled to stabilizing treatment or an appropriate transfer.

Chip Kahn (06:00):

Clearly there’s so many implications from what you just described from EMTALA, much less all the other requirements that hospitals and clinicians need to comply with at the state and federal level, but to maybe get a better understanding here of what hospitals and clinicians face, we should have some illustrations and you could comment maybe on these scenarios or hypotheticals I’ll present. I think that’s probably the best way to begin to think about this by having use cases. So let’s sort of start with EMTALA since you just described it. I’ll give you the situation. A pregnant woman in premature labor is admitted to a hospital’s labor delivery unit. The health care professionals overseeing her care perform a sonogram and determine that the fetus is not viable and has no chance of survival. Should the hospital remove the fetus? If so, would the hospital be violating state law if they did? If not, would the hospital be violating EMTALA?

Tom Barker (07:07):

So a couple of points in that hypothetical that I think are important to draw out. In the hypothetical, the woman has come to the hospital’s labor and delivery unit. CMS has made clear in regulations that were adopted in 2003 that a labor and delivery unit can be an emergency department, even though it’s not traditionally thought of as the emergency department. So I think the first point I’d like to make with respect to that hypothetical is that clearly the hospital has an EMTALA obligation, even if the woman doesn’t walk through the door that says emergency, but instead comes to the labor and delivery unit. The hospital does have an obligation under EMTALA.

Tom Barker (07:45):

The second point is depending upon the state where this scenario occurs, it may be possible that the hospital, by removing the unviable or non-viable fetus, has violated state law. However, there is no question, but then in that scenario, the woman does have rights under EMTALA and the hospital has obligations under EMTALA to provide stabilizing treatment. In that case where you have a conflict between state law and federal law, and I’m sure this is going to come up in further scenarios, but when you have a conflict between the federal EMTALA law and state law, the federal law is going to prevail.

Chip Kahn (08:29):

Would it make a difference in this case if the fetus actually has died?

Tom Barker (08:34):

So there’s no question in that case that the hospital has an obligation under EMTALA to provide stabilizing treatment, to remove the deceased fetus. There may be a conflict between state law and federal law, but there is no question but that federal law prevails. Federal law preempts state law in this instance.

Chip Kahn (08:56):

So let’s try another one. An OB/GYN physician in Texas is employed by a healthcare system. While working a shift in an emergency care clinic lacking a labor delivery unit, the physician is presented with a pregnant patient who is experiencing an emergency medical condition. The labor department does not have the capability to perform the required procedure necessary to stabilize the patient. With the written consent of the patient, the physician transfers her to another health care facility, which ultimately performs an abortion procedure. Can the healthcare facility employing the OB/GYN physician be held civilly or criminally liable, even though the OB/GYN physician did not perform that abortion? Given the fact that EMTALA requires a physician to stabilize a patient experiencing an emergency medical condition, know what happens here?

Tom Barker (09:49):

Yeah. There are a couple of factors at play in this question. This question focuses on the federal side on the obligations that a hospital has under EMTALA to provide an appropriate transfer if the hospital doesn’t have the capabilities to provide the necessary stabilizing treatment. So in this scenario, as you described it, the hospital did provide inappropriate transfer. The physician got consent of the patient and the transfer was appropriate because the medical benefits of the transfer outweighed the risk, and assuming that the transfer was done properly through appropriate transfer of medical records in an ambulance, et cetera, it seems like the hospital complied with EMTALA.

Tom Barker (10:34):

Whether or not the physician may have violated state law by transferring the patient to another facility that did perform the abortion to me is almost irrelevant because I think, again, the legal analysis is the same. EMTALA trumps state law. EMTALA supersedes state law. In this instance, because state law is preempted by EMTALA, the hospital should not face liability under state law because the EMTALA statute controls. I’d also like to mention, Chip, that on September 17th of last year, CMS issued guidance to the state surveyors that oversee and are responsible for conducting investigations regarding EMTALA complaints. CMS issued guidance on September 17th of last year that spelled out in great detail its analysis of this issue regarding preemption, and in doing so made clear that EMTALA is going to preempt state law.

Chip Kahn (11:32):

In the two examples we talked about, the patient was in an extreme situation and extremists, but there’ll be other patients that are seriously ill, may have a life threatening illness, but is not in an emergency situation. Let me give you this hypothetical. There will be cases of such serious illness where a pregnant woman has cancer and is admitted to a hospital’s inpatient unit to receive chemotherapy. The health care professionals overseeing her care determined that the chemotherapy has the potential to threaten the life of the fetus. Does the hospital have a legal obligation to provide the pregnant woman with the therapy, the chemotherapy, if the woman asks to go forward and what are the implications for the viability of the fetus and the implications of the treatment when it could, in a sense, cause this problem for the pregnancy itself?

Tom Barker (12:31):

What’s interesting about this question, what’s changed in the fact pattern, is that the woman has not come to the emergency department, but rather has been admitted as an inpatient. CMS addresses this in the guidance that I just referenced and CMS’s position is that EMTALA ends on a patient’s admission as an inpatient and the hospital, according to CMS, no longer has EMTALA obligations. Just one quick point I’d like to make about that. I would note that the U.S. Court of Appeals for the Sixth Circuit, which covers the states of Michigan, Tennessee, Kentucky, and Ohio, does not recognize that CMS interpretation of EMTALA and has in fact rejected that interpretation of EMTALA. So at least hospitals in the Sixth Circuit, the court’s view is that EMTALA obligation is still attach.

Tom Barker (13:26):

But regardless of whether or not an EMTALA obligation attaches in the scenario that you just described, the hospital is still obligated by Medicare’s conditions of participation to provide treatment to the individual. CMS has stressed that in the guidance that I mentioned that was issued in September of last year. The hospital still must provide appropriate care to inpatients. The pregnant woman likely would be able to make a case that she has a legal right to receive chemotherapy even if that treatment harms the baby, because one of Medicare conditions of participation says that clinicians at the hospital are responsible to the governing board of the hospital for providing quality care to patients. If a hospital fails to meet the conditions of participation, or the COPs, their Medicare provider agreement could be terminated.

Tom Barker (14:20):

So I would say even in that scenario, that if the pregnant woman, in the judgment of her physician, needs chemotherapy, even if the chemotherapy might harm or cause the death of the fetus, nevertheless Medicare’s conditions of participation and possibly EMTALA require the provision of that care.

Chip Kahn (14:43):

Let’s take another Texas example. A pregnant woman in premature labor is admitted to a hospital’s labor delivery unit. The health care professionals overseeing her care perform a sonogram and determine the fetus is no longer alive or viable. The emergency room physician removes the fetus as medically required, as determined by the physician, and to ensure the mother does not become septic. If enforcement action is taken against the hospital for providing services to remove the fetus pursuant to Texas’s private citizen enforcement mechanism, does Texas law or federal law prevail in that case?

Tom Barker (15:24):

Well, let’s break that question down as well, because that question involves both an analysis of EMTALA’s screening obligations and stabilization requirements. So the woman likely received the sonogram as part of a screening to determine whether or not an emergency medical condition exists. If the result of that sonogram shows that the fetus has died, then the woman is entitled to stabilizing treatment and she is entitled in that instance to have the treatment, which surely would include the removal of the deceased fetus. Again, here EMTALA preempts state law. One point I would like to make about EMTALA preemption is that the statute is quite clear on this point. The statute says that in general EMTALA doesn’t preempt a state law unless, and this is the key phrase, unless to the extent that the requirement directly conflicts with the requirement of this section.

Tom Barker (16:30):

Here, in this guidance, CMS has clearly taken the position that a contrary state law that either provides for enforcement or perhaps criminal penalties for someone who performs an abortion, CMS has clearly taken the position that that is a contrary state law that directly conflicts with EMTALA and therefore EMTALA preempts state law.

Chip Kahn (16:52):

Before I go off to another area of example, let me ask a corollary question. So do you think, considering what you’ve described in these hypotheticals, that there still will be some court action? Can you give us any idea of what you think that process is likely to be to sort of settle this issue between these new state laws and settled law in a sense around EMTALA?

Tom Barker (17:23):

That’s a really interesting question. For one thing I can see playing out is that a lawsuit gets filed against a provider either by law enforcement officials in a state, or you just mentioned, Chip, the Texas example, the Texas private right of action. A claim gets filed in state court, not in federal court. EMTALA, of course, is a federal statute. I think there’s a real question whether or not the defendant in that case would have the ability to remove a state law claim to federal court, knowing that they would use EMTALA as a defense, or at the very least they would use EMTALA as a defense in the state court action. I think it is quite likely that we are going to see litigation, likely filed in the state court rather than federal court, because to me, the preemption analysis is so clear under EMTALA, but I think that it is quite possible that there will be litigation filed and I think that the defense that a defendant would use is preemption under EMTALA.

Chip Kahn (18:30):

Interesting. Well, let’s move on into another area. A state with one of these new laws regarding abortion has a conscience law also, which permits health care professionals with an objection to abortion services to refuse participation in a procedure without adverse employment consequences. A pregnant woman is admitted to an emergency department. The health care professionals overseeing her care cannot determine if an abortion will be necessary to save the mother’s life. One of the health care professionals is a nurse who objects to caring for the patient because there is a possibility in abortion may be performed. Can the hospital require the nurse to provide medical treatment as a matter of employment?

Tom Barker (19:16):

I think here there’s … You’re right that there are also state conscious laws. There are also some federal laws that protect conscience rights as well and we’ve seen those emphasized in the past as well by HHS officials. I would say that in that scenario, a health care personnel such as a nurse, for example, that doesn’t want to participate in the procedure still has a right under a state conscience law or federal conscience law to refuse to participate in the procedure without suffering adverse employment consequences. I don’t think that there’s anything in the Dobbs decision or anything in EMTALA that would change those conscience rights. So I think that those conscience rights are still protected, even not withstanding the Dobbs decision, not withstanding EMTALA.

Chip Kahn (20:08):

One of the other areas that I’m sure issues will arise is in the issues of privacy, record privacy. HIPAA is all pervasive in terms of governing records for patients, but let’s take our example. A hospital in a state that restricts abortion services does blood work and performs an ultrasound for a patient who is experiencing an emergency medical condition. These tests confirm that she is pregnant. So the hospital stabilizes the patient. After this confirmation, the woman informs the treating physician that she does not want to have the baby and will be traveling to another state without abortion restrictions the following week to receive an abortion. Subsequently, the patient receives an abortion in that state and then returns to the home state. Does the hospital in that state have an obligation to report this information once it’s learned that the woman intends to receive an abortion in another state?

Tom Barker (21:08):

So you’re right. This does certainly implicate the HIPAA statute. HIPAA does permit a covered entity that is otherwise bound by HIPAA’s privacy requirements to disclose protected health information without consent or without authorization to law enforcement officials or in response to a judicial or to an administrative proceeding. So I think the issue that you’re highlighting here, Chip, is would the health care professional to whom the woman discloses this information or for whom it is just obvious that the woman had an abortion, whether or not they’re obligated to disclose that otherwise protected health information to law enforcement officials?

Tom Barker (21:52):

HHS’s Office of Civil Rights recently addressed this issue and issued some guidance on this point. What OCR says … OCR, again, is the HHS Office of Civil Rights. What OCR says is that where state law does not expressly require reporting, the privacy rule, the HIPAA privacy rule, would not permit disclosure to law enforcement officials under the required by law exception of HIPAA. It would be a violation of the HIPAA privacy rule for a hospital to disclose that information to law enforcement officials. So again, OCR’s policy seems to be that unless state law expressly requires reporting, that it would be a violation of HIPAA for a hospital or medical personnel to otherwise disclose that information to law enforcement.

Chip Kahn (22:47):

Let’s look at another privacy scenario. A pregnant woman self-administers an abortion and subsequently experiences complications. She visits the emergency department of a hospital to stabilize her emergency medical condition. If state law requires reporting of suspected self-administered abortions and federal law does not require such reporting, is the hospital required to report this event to law enforcement?

Tom Barker (23:14):

I think in this scenario what’s different in this hypothetical than the preceding one is that state law expressly requires reporting. In that case, I think the healthcare personnel would face an obligation under state law to report that information to law enforcement officials. That seems to be OCR’s position at the moment.

Chip Kahn (23:38):

Let me give a final example here. A licensed physician is employed by a multi-state healthcare system. During a telemedicine consultation, a New York based physician prescribes FDA approved abortion medication to a patient living in a rural and medically underserved area, lacking access to healthcare facilities for hundreds of miles, let’s say. Can the healthcare system be held civilly or criminally liable for employing the physician and, as a result, helping procure an abortion?

Tom Barker (24:11):

My sense is that HHS’s position, and this was reticulated in the days following the Dobbs decision, that states cannot restrict the availability of an FDA approved treatment, medical treatment. So here, if the doctor has prescribed the abortion medication, a medication that causes an abortion to a patient, that medication is legally available because it’s been approved by the FDA and therefore approved under the Food, Drug, and Cosmetic Act. It was legally available in that state, even though the state might have a law to the contrary. HHS’s, FDA’s position seems to be again in the days immediately following the Dobbs decision that no state law can override an approved FDA medication.

Tom Barker (25:09):

I will say that I’m hesitating and caveating this a little bit because there is a Supreme Court decision from 2009 called Wyeth versus Levine that does seem to permit a state to regulate beyond the FDA label of a medication. I don’t think that HHS has fully grappled with that yet, so there may be further guidance forthcoming, but as things stand right now, I think HHS’s and FDA’s position is clear that the physician could not be prosecuted under state law because federal law permits the dispensing of that medication.

Chip Kahn (25:51):

I assume that the state legislatures are going to modify their laws to bring this to a question in the courts eventually, I would guess.

Tom Barker (26:00):

I think you’re right, that there are going to be many types of litigation filed, both in state court and federal court, testing how far the reach of the Dobbs decision is, and also where there are conflicts between state law and federal law, whether it’s EMTALA, HIPAA, the Food, Drug, and Cosmetic Act, other provisions of federal law that seem to supersede state law, those things are going to have to get tested out in the courts.

Chip Kahn (26:32):

Wow. It sounds like we’re going to have a lot to deal with because when the patients present, the hospitals and clinicians are obligated to provide the care and it’s our purpose there to provide good care for those patients. Some of these medical questions are going to be unavoidable. Do you have anything to add to what we’ve talked about, Tom, sort of in conclusion?

Tom Barker (26:55):

I guess a couple of points that I would make. I would certainly recommend that those listening to this podcast make themselves familiar with the provisions of the September, 2021 CMS guidance regarding EMTALA, the state surveyor guidance. The OCR guidance on HIPAA, the statements that are coming out of HHS with respect to Food, Drug, and Cosmetic Act preemption. Also, I’m quite certain that there are going to be continued guidances coming out from HHS in the coming days as questions arise. I realize that this might be of small comfort to those clinicians who are facing on a real time basis these complicated, legal, ethical, moral medical questions. I think that the best that we can say is to continue to be on the lookout for guidance, because I know that HHS intends to continue to make guidance available.

Chip Kahn (27:56):

Toms, thank you so much for your thoughtful analysis and working your way through these very, very tough scenarios that, unfortunately, I think on the ground, we’re going to have clinicians and hospitals having to deal with situations like we described and comparable ones in the near future as they take care of patients who present with difficult pregnancies or other kinds of issues related to reproductive health. So with that, I just want to thank you and express our appreciation for your being with us today.

Tom Barker (28:33):

Thanks for the opportunity, Chip. I appreciate it.

Speaker 1 (28:40):

Thanks for listening to Hospitals In Focus from the Federation of American Hospitals. Learn more at fah.org. Follow the Federation on social media @fahhospitals, and follow Chip @chipkahn. Please rate, review, and subscribe to Hospital In Focus. Join us next time for more in-depth conversations with healthcare leaders.

Thomas Barker has been a partner at Foley Hoag since March of 2009. Tom focuses his practice on complex federal and state health care legal and regulatory matters with a special expertise in Medicare and Medicaid law including coverage, reimbursement, and regulatory oversight. In May of 2019, he was appointed as a commissioner of the Medicaid and CHIP Payment and Access Commission (MACPAC), an advisory body that provides policy advice to Congress and the states on the Medicaid and CHIP programs. He is one of the authors of the firm’s Medicaid & the Law blog, www.medicaidandthelaw.com, which highlights and explains current legal and policy issues in the Medicaid program.

Prior to joining the firm, he was acting General Counsel of the U.S. Department of Health and Human Services (HHS) and General Counsel of the Centers for Medicare & Medicaid Services (CMS).