Category: Emergency Department

“Observation status” was originally conceived of as a way to watch patients presenting to the emergency department for a few hours in order to determine whether or not they needed to be admitted to the hospital. The purpose was to reduce unnecessary inpatient hospitalizations and thus reduce overall healthcare costs. But there has been a creep in the use of observation status as well as the healthcare bureaucracy to administrate it. The result is that observation status has now increased overall healthcare costs. It is time to consider eliminating observation status in the United States.

How did we get here?

Prior to 1960, emergency departments were staffed by residents and general practitioners. The doctor who saw you in the ER was generally the same doctor who took care of you in the hospital. Emergency medicine became a specialty in 1968 with the creation of the American College of Emergency Medicine. The first emergency medicine resident began training in 1970 and the first board examination in emergency medicine was offered in 1980. The result was that the doctor that took care of a patient in the ER was no longer the same doctor who took care of them once they were admitted to the hospital. In 1983, DRGs were first used to determine the amount of money that Medicare would pay hospitals for inpatient admissions for any given diagnosis. After the introduction of DRGs, it became immediately clear that there needed to be some way of determining which patients were sick enough to warrant admission to the hospital from the emergency room, otherwise, the hospitals would be incentivized to admit as many people as possible, even if they were not very sick.

Initially, that determination was left to the emergency room physician. But that ER doctor needed to find an inpatient physician who would agree to admit the patient. During my residency, we had a designated “medical admitting resident” each day who would make the decision about which patients were sick enough to require admission. Some residents got the reputation of being “sieves”, meaning that they would admit everyone that the ER physician called them about whereas other residents got the reputation of being “walls”, meaning that they would block admissions from the ER unless the patients were at death’s door. You always wanted to be on-call at night with a resident who was a “wall” because that meant you would have to do fewer history and physical exams, your inpatient service census would be lower, and you might actually get a few hours of sleep that night.

In order to provide some rules for which patients warranted inpatient admission, Medicare directed that patients who could be sent home within 24 hours should be observed in the ER rather than admitted to the hospital. However, keeping a lot of patients in ER beds for 24 hours was impractical so hospitals started putting those observation patients in regular hospital beds to avoid congestion in the emergency department. The unintended consequence was that this simply led to keeping patients in the hospital for longer than 24 hours, just so they could be classified as inpatients. This was especially a problem with outpatient procedures when many hospitals kept patients overnight for procedural recovery and then billed Medicare for both the outpatient procedure plus an inpatient hospital admission. Medicare countered in 2002 by agreeing to pay hospitals specifically for observation stays in order to provide an alternative to inpatient admission for those patients who were only mildly ill or who needed extra time to recover from an outpatient procedure. Initially, the only diagnoses that could be billed as observation stays were heart failure, chest pain, and asthma. In 2008, Medicare began paying for observation stays for all diagnoses.

In parallel with the development of reimbursement policies for observation stays, Medicare began policing hospital admissions by using the RAC (recovery audit contractors). RAC auditors would review the charts of patients who had been admitted to the hospital and if the auditor determined that there was not sufficient documentation in the chart to justify inpatient admission, Medicare would collect penalties from the hospital for overpayment. By 2014, the RAC program had collected $2.3 billion from hospital overpayments. One of the most common reasons by RAC auditors when denying an inpatient admission was that “…the patient could have safely and effectively been treated as an outpatient.” The auditors were often incentivized to deny admissions since more denials often led to bigger bonuses for the auditors. As a result, the denials were frequently capricious and arbitrary. 25 years ago, a coder for a commercial insurance company confided in me that her supervisors told her to randomly deny every 10th hospital admission because hospitals usually found that it was too expensive to contest denials. Fear of RAC audits resulted in physicians and hospitals increasing the use of observation status in order to avoid the risk of being penalized for an unnecessary inpatient admission.

A second strategy employed by Medicare was to create a list of surgical procedures that were classified as “Medicare Inpatient-Only Procedures”, meaning that those operations required an inpatient admission. Any surgical procedure not on the list was to be classified as an outpatient procedure unless there were extenuating circumstances that uniquely required a patient to be admitted to the hospital. Medicare pays much more if a surgery is performed as an inpatient (Medicare Part A) than if it is performed as an outpatient (Medicare Part B). Over time, the Medicare Inpatient-Only list shrank as more and more surgical procedures were reclassified as being appropriately done as outpatient and not requiring of hospital admission. Thus, knee and hip replacement surgeries were initially considered to require inpatient admission  but are now considered to be outpatient procedures.

Medicare also changed its definition of observation stays to be any condition that requires the patient to be in the hospital for “less than 2 midnights”. Although it could be argued that this gave hospitals longer than 24 hours to treat an observation status patient and send them home, the 2-midnight definition was somewhat arbitrary. For example, a patient presenting to the emergency department at 11:00 PM would spend 25 hours in the hospital before crossing 2 midnights but a patient presenting at 1:00 AM would spend 47 hours in the hospital before meeting the 2-midnight definition. However it is not how many midnights a patient actually spent in the hospital that Medicare auditors used when deciding whether to deny a hospital admission. Instead, it is whether the auditor believed that had the patient been managed appropriately, that patient could have been sent home before 2 midnights have elapsed. For example, if a patient came to the emergency department on Saturday evening with chest pain but the hospital could not do a cardiac stress test until Monday morning (2 midnights later), the auditor would still deny an inpatient admission since if the hospital offered 7-day a week stress tests, they could have sent the patient home on Sunday (after 1 midnight).

The observation vs. inpatient status bureaucracy

In order to avoid losing money from admission denials, hospitals started to go to great lengths to insure that the medical record contained sufficient documentation to justify every hospital admission. This was greatly facilitated by the development of electronic medical records that permitted realtime review of each patient’s hospital stay to ensure that the patient’s chart had appropriate documentation to meet Medicare’s requirements to bill that hospital stay as an inpatient admission. Some of the measures that hospitals now take in order to oversee their hospital admission practices include:

1. Physician training. When a patient is admitted to the hospital from the emergency room, the admitting physician has to enter an order directing that the patient is an “inpatient” or “observation” admission. This means that the physician has to estimate how long the patient will need to be in the hospital at the very beginning of the hospital stay and that estimated length of time dictates whether a patient will be inpatient or observation status. We now train residents in how to correctly estimate length of stay. For example, patients admitted for chest pain, syncope, and dehydration are generally observation status unless there are extenuating circumstances.
2. Nurse admission reviwers. Hospitals will generally hire a group of nurses or other healthcare workers to review every patient’s chart on a daily basis to determine if the medical record documentation justifies inpatient admission. These nurses get special training in the Medicare inpatient admission requirements. If the patient’s chart does not contain the proper documentation, the nurse’s first step is usually to contact the physician since frequently, all that is needed is an extra sentence or two in the medical record describing how sick the patient actually is. If that does not resolve the issue, the next step is to contact a physician admission advisor.
3. Physician admission advisors. Many times, the admitting physician is uncertain whether or not a patient’s illness justifies an inpatient admission order. Or the nurse reviewer’s determination is different from the physician’s admitting order for observation vs. inpatient status. For this reason, hospitals employ physicians whose main job is to arbitrate inpatient and observation orders. Often, this will be a private physician review company where the physician reviewers can access patient charts on a daily basis. Larger hospitals usually do this internally by hiring some of its own emergency medicine physicians or hospitalists to dedicate a certain number of hours per day reviewing admissions.
4. Hospital medical directors. When another layer of physician review of how to classify a patient’s admission is required, it then goes to the hospital medical director. Even for a small hospital, this is usually several charts to review every week. It takes about 15-20 minutes to do one of these reviews and then contact the admitting physicians to try to talk them into changing an admission order from inpatient to observation or vice-versa. Frequently, it requires the medical director to either enter an administrative note in the electronic medical record or to send the hospital utilization review office a letter so that the hospital has a documentation  paper trail in the event of a Medicare denial. More often, the medical director is sent charts for patients who had an inpatient admission order but were discharged before 2 midnights had elapsed. This is a red flag for Medicare auditors. We then have to provide written documentation for why the patient should be billed as an inpatient. Sometimes, this is easy, for example, when a patient dies from their condition in the hospital before 2 midnights elapse. But more frequently, it is because the admitting physician legitimately believed that the patient would need to be in the hospital for at least 2 midnights when that patient first arrived at the hospital. Several years ago, I attended a Medicare seminar and one of the medical administrators from Medicare told us that when this happens, we should use the phrase “The patient had an unexpectedly rapid recovery and was able to be discharged after less than 2 midnights”. Pretty much every time a patient in inpatient status was discharged before 2 midnights, one of our hospital medical directors would review that chart and send the billing office a letter using that phrase.
5. Pre-admission testing consultation. Patients who are planned to undergo a surgical procedure will frequently be sent for pre-operative medical consultation by an internist, family physician, or specially trained advance practice provider. Although designed to identify medical co-morbidities that could increase the risk of complications during surgery, these consultations are increasingly being used to determine whether or not a given patient’s surgery should be classified as an inpatient or an outpatient surgery. And most importantly, these consultations ensure that there is sufficient documentation in the electronic medical record to justify an inpatient procedure. For example, most knee replacement surgeries are now considered outpatient procedures. But if the chart documents that the patient has sleep apnea requiring CPAP, brittle diabetes, COPD requiring supplemental oxygen, and a history of vomiting after anesthesia, then that patient’s knee replacement can be done as an inpatient and the hospital gets paid considerably more. Surgeons are trained to be experts in surgery but are not trained in the nuances of co-morbid medical illnesses that they do not normally manage. Consequently, the surgeon’s outpatient notes often do not contain documentation of the significance of those medical co-morbidities and whether they are severe enough to warrant an inpatient admission for the surgery. That is why the pre-op medical consultation is so highly valued. If the surgeon admits the patient as an inpatient to do the surgery and then discharges that patient before 2 midnights pass, the chart once again gets sent to the medical director so that a letter containing the phrase “The patient had an unexpectedly rapid recovery and was able to be discharged after less than 2 midnights” is sent to the utilization review and billing offices for a documentation paper trail in the event of an admission denial by Medicare.
6. Utilization review staff. Every hospital employs a large number of personnel devoted solely to coding, billing, and utilization review. Before a bill goes out to Medicare or a commercial insurance company, these staff will do a final review to ensure that all of the proper documentation justifying an inpatient admission is present in the chart, including physician admission advisor notes and hospital medical director correspondence.There will also usually be personnel whose only job is to work denials when Medicare or an insurance company denies an inpatient admission. These personnel will then prepare and submit documentation contesting that denial in hopes of overturning the denial and getting paid for the hospital stay.
7. Attorneys and peer reviewers. When Medicare or an insurance company refuses to overturn an admission denial after the billing staff contest the denial, the next step is to turn to the legal system. This usually starts by paying an independent physician reviewer to opine whether the patient’s hospital stay should be classified as inpatient or observation. Next, hospital attorneys get involved by contacting Medicare attorneys about the denial. Sometimes, contested denials require adjudication, requiring more attorney time.
8. Medicare staff. On the other side of the bill, Medicare and commercial insurance companies employ large numbers of staff to review charts to decide whether they think that hospitalizations should be inpatient or outpatient.

So, for any given patient’s hospitalization, there is an army of Medicare nurse reviewers, physician reviewers, utilization review staff, and attorneys that face off against an army of the hospital’s  nurse reviewers, physician reviewers, utilization review staff, and attorneys. In the end, more money is sometimes spent battling an admission denial than is actually paid to the hospital for the admission. Hospitals are willing to occasionally spend the excessive cost to contest a denial since it sends Medicare or the insurance company a signal that the hospital will not go down easily for future admission denials. It is kind of like a basketball coach throwing a tantrum about a penalty call in order to try to dissuade the referee from calling future penalties.

The net result of all of this is that the United States has created an enormous bureaucracy devoted to preventing and contesting hospital admission denials.  So, why don’t hospitals just classify more patients as being in observation status and avoid all of the expense of justifying inpatient status? The reason is money.

The finances of inpatient vs. observation status

The genesis of observation status was to reduce Medicare costs by eliminating unnecessary hospital admissions. For any given diagnosis, hospitals get paid much less if a patient is designated to be in observation status than if that same patient is designated to be in inpatient status. Overall, the reimbursement is about 1/3 less for observation stays. In other words, Medicare can reduce overall Medicare costs by pressuring hospitals to put more patients in observation status. The same holds for commercial insurance companies.

Until several years ago, Medicare also paid doctors less if patients were in observation status. However, it became clear to Medicare that this was incentivizing doctors to preferentially use inpatient status rather than observation status. And since doctors are the ones who write the admission orders, Medicare realized that it could reduce inpatient admissions by removing the physician financial incentive to put patients in inpatient status. Because the physician professional fees are much, much less than the hospital fees, by paying physicians the same whether a patient was in observation or inpatient status, Medicare would pay a little more to the doctors but would pay a whole lot less to the hospitals.

But the biggest savings to Medicare in observation status is that it transfers much of the cost of the hospital stay from Medicare to individual patients. This is because Medicare considers observation stays as outpatient visits. Outpatient services are billed to Medicare Part B but inpatient services are billed to Medicare Part A. This is hugely important to patients because patients have much higher co-pays and deductibles for their Part B charges than their Part A charges.

• Medicare Part A covers inpatient admissions including a semi-private room, nursing care, medications, meals, and tests done during inpatient admissions. Part A also covers skilled nursing facility care, home health care, and hospice care. Medicare Part A is free to Americans over age 65 who have previously worked at least 10 years (or have a spouse who worked 10 years). There are no monthly premiums and no annual deductible. The amount that Medicare covers depends on the length of stay of the hospital admission:
  • $1,600 deductible per admission
  • Days 1-60: Part A covers in full
  • Days 61-90: patients are responsible for $400 per day co-pay, either by co-insurance or out of pocket if the patient lacks co-insurance
  • Days 91-lifetime reserve limit days: patients are responsible for $800 per day co-pay, either by co-insurance or out of pocket if the patient lacks co-insurance
  • After lifetime reserve limit days (total of 60 over the entire lifetime): Part A pays nothing and patients (or their co-insurance) are responsible for the entire costs
• Medicare Part B covers hospital outpatient charges and physician professional charges. Unlike Part A, there is a monthly premium for Part B of $165/month with higher premiums for those with higher incomes. There is an annual deductible amount of $226. Patients also have additional deductibles and co-pays that are either paid by secondary insurance or out of pocket if there is either no secondary insurance or the insurance policy has limited benefits:
  • 20% co-pay for all physician charges
  • 20% co-pay for hospital outpatient charges (hospital room, nursing care, meals)
  • 20% co-pay for x-rays and procedures
  • Part B does not cover medications so the patient (or their Part D insurance) is responsible for medication charges during observation stays

The net result of these differences is that the patient will have greater out of pocket expenses for an observation stay than for an inpatient admission. This is especially true for the 7.5% of Americans over age 65 who are enrolled in Medicare Part A only and do not enroll in Medicare Part B – these patients pay the entire cost of their observation stay out of pocket.

Another financial implication of observation vs. inpatient stays is in skilled nursing facility (SNF) coverage. Medicare Part A pays for 100% of SNF charges for up to 20 days (there is a $200/day co-pay for days 21-100). However, Medicare will only pay for SNF care if a person first has an inpatient hospital stay of at least 3 days. Medicare will not pay for SNF care after an observation stay. If a patient is in observation status (or has an inpatient stay of < 3 days) and gets transferred to a SNF, the patient is responsible for all of the SNF charges.

Why observation status is really, really dumb

CMS absolutely loves observation status. It reduces Medicare costs by paying the hospitals less for any given diagnosis and it also reduces Medicare costs by transferring much of the costs directly to the patient. This allows CMS officials to report to Congress that they are reducing federal spending on healthcare. Congressional representatives can then report to voters that they are reducing government spending. But there is no such thing as free healthcare… the cost of healthcare does not go away, it just gets transferred to the patient. The individual American ends up with more out of pocket costs for co-pays, medication charges, and SNF costs that would have otherwise been covered by Medicare Part A had their hospital stay been inpatient status as opposed to observation status. So, in the long run, the average American does not save any money by being in observation status.

Nationwide, 16% of all hospital stays are observation stays and 84% are inpatient stays. But this percentage can vary widely from hospital to hospital. A tertiary care referral hospital will usually have a lower percentage of observation stays since its patients tend to be sicker with more complex medical problems. On the other hand, a community hospital, especially one that cares for underserved patients, will have a higher percentage of observation stays, typically 25% or more. About the best a hospital can hope for is to break even on observation patients – most hospitals actually lose money on observation stays.

It’s bad enough that observation status does not really save money by transferring the cost of care to the individual patient rather than Medicare. The worst part about observation status is that it actually increases U.S. healthcare expenses. Not only do hospitals have to spend an enormous amount of money justifying inpatient admissions and working inpatient denials, but Medicare spends an enormous amount of money paying staff who police admissions in order to deny inpatient admission charges.

The net result is that observation status represents the epitome of U.S. healthcare dysfunction. It has led to an enormous bureaucracy devoted entirely to deciding whether Medicare or individual patients should pay for hospital care. And that bureaucracy is enormously expensive.

How can we fix this?

Americans pay way more for healthcare than people in any other country. In 2021, the average per capita healthcare cost in the U.S. was $12,914. It will undoubtedly be much higher in 2023. One of the contributors to this is too much of the healthcare costs go into trying to decide whether Medicare or the individual American will be responsible for paying for healthcare. Getting rid of the observation status designation can reduce U.S. per capita healthcare costs. Here is how to do it:

1. Create low-acuity DRGs. For conditions that are currently commonly managed by observation status (chest pain, syncope, dehydration, etc.), CMS can create inpatient DRGs that pay the hospital less, thus simulating the amount that CMS would have paid for an observation stay.
2. Require a modest Part A co-pay for hospitalization. The biggest argument against eliminating observation status is that Medicare costs would go up since co-pay costs currently paid by patients would go back to Medicare. The solution to this would be to require a small co-pay for hospitalization days 1-60. The amount to keep Medicare’s annual budget neutral could be as little as $10 or $20 per day.
3. Outpatient should mean outpatient. How in the world we ever got to the point that we define outpatient care as needing to be in the hospital for more than 2 midnights is baffling. Either a patient needs to be in the hospital or they don’t. I once had a admission denial for a patient in respiratory failure admitted from the ER to our ICU on a mechanical ventilator. The Medicare reviewer said that in his opinion, I should have been able to correct the respiratory failure, extubate the patient, and discharge her before 2 midnights passed. Really?
4. Eliminate the SNF 3-day rule. The whole idea behind the 3-day rule was that Medicare wanted to see if a patient really needed SNF care before it would pay for it. But the unintended consequence is that if one of our patients needs to go to a SNF, we have to figure out a way to admit them to the hospital for at least 3 days first. This means that we have to wait until they fall at home and break their hip or wait until they get septic from an infected decubitus ulcer if they are unable to get out of bed. For patients undergoing surgery, such as a knee replacement, we have to keep them in the hospital for 3 days after their surgery before they can go to a SNF for rehabilitation, even if they live alone and cannot walk after their operation.
5. Eliminate the observation industry. By eliminating observation status, hospitals would no longer have to spend money on nurse admission reviewers, physician admission advisors, and medical directors who laboriously review charts for inpatient justification. Hospitals could reduce their utilization management staff and Medicare could reduce its admission reviewer staff. Hospitals, patients, and Medicare would have less need for attorneys to contest admission denials. Yes, a lot of people would lose their jobs but the overall U.S. healthcare costs would drop.

Elimination of the observation status designation would make everyone happy. Patients would not be surprised by unexpectedly high hospital bills. Doctors would not have to spend time entering unnecessary documentation in their hospital notes to justify why a patient warrants an inpatient admission. Hospitals would not have to pay as much for staff to oversee admission determination. A fundamental concept of industrial engineering is that the more complex a process is, the more energy it takes to keep that process working. Observation status has created a terribly complex process. It is time to simplify the U.S. admission process.

January 22, 2023

For decades, the mainstay of asthma treatment has been a daily maintenance steroid inhaler coupled with an as-needed albuterol rescue inhaler. New evidence suggests that there are better options than albuterol and that it may be time to retire the albuterol inhaler for asthma.

The metered-dose inhaler was invented in 1955, when 13-year-old Susie Maison asked her father why she had to take her asthma medication in a squeeze bottle and why it could not be put into a can, like hairspray. Her father was the president of Riker Laboratories (now 3M) and thought that his daughter was onto something. Within a year, Riker released the Medihaler-epi and Medihaler-iso, containing the β-agonists, epinephrine and isoprenaline, respectively. These gave way to the β-agonist inhalers that I prescribed in the 1980’s: Alupent (metaproterenol), Maxair (pirbuterol), Brethaire (terbutaline), Tornalate (bitolterol), Proventil (albuterol), and Ventolin (albuterol). With the international agreement to eliminate inhalers containing chlorofluorocarbons, all of these except albuterol were taken off the market by 2010.  And so, for the past 12 years, albuterol (also known as salbutamol outside of the United States) has been the sole short-acting β-agonist available in the United States.

Why use albuterol in asthma, anyway?

Asthma is an obstructive lung disease where the airways of the lungs become narrowed. This narrowing is caused by a combination of bronchospasm and inflammation. Bronchospasm is caused by contraction of the smooth muscles that line the airways and can be relieved by β-agonists, such as albuterol. Inflammation is caused by a group of biochemicals that cause white blood cells such as neutrophils, eosinophils, and lymphocytes in the airways to become activated resulting in swelling of the airway walls and secretion of mucus into the airways. Inflammation can be relieved by corticosteroids.

β-agonists can relieve the bronchospasm component of airway narrowing almost immediately but steroids take hours or days to relieve airway inflammation. Albuterol and other β-agonists only relieve bronchoconstriction and have no effect on inflammation. Albuterol’s duration of action is 3 – 6 hours. Therefore, in an asthma flare, β-agonists alone can provide partial short-term improvement in airway narrowing but will not relieve the underlying inflammation. For decades, asthma treatment has required albuterol and steroids to be given separately. Albuterol and other β-agonists are most commonly given by inhalation, either via a metered-dose inhaler or by a nebulizer. Steroids can be given via metered-dose inhalers on a scheduled basis for prevention of asthma flares. Steroids can also be given by pills (such as prednisone) or by intravenous infusions (such as methylprednisolone) once a patient’s asthma flares up.

The argument against inhalers containing only albuterol

This month, the MANDALA study was published in the New England Journal of Medicine that indicates that a combination of albuterol plus the corticosteroid budesonide in a single inhaler is better for relieving asthma symptoms than an albuterol-only inhaler. In this randomized double-blind study, 3,132 subjects with moderate to severe asthma at 295 different centers worldwide (including the U.S.) were given a rescue inhaler containing only albuterol or were given a rescue inhaler containing both albuterol and budesonide. Those subjects who received the albuterol + budesonide inhaler had 26% fewer severe asthma flares than those who received albuterol alone. The implication of the study is that when a person’s asthma flares up, treating both inflammation and bronchospasm is more effective than treating bronchospasm alone.

This reinforces the asthma treatment guidelines recommended by GINA (the Global Initiative for Asthma). GINA began as a collaborative effort of the U.S. National Institutes of Health and the World Health Organization and over the past 29 years, it has become the gold standard for asthma treatment recommendations. The 2022 GINA Report recommends that the first line asthma reliever treatment should initially be a combined formoterol (a long-acting β-agonist) + steroid inhaler and if this is not available, then the second line is to use two inhalers: an albuterol (a short-acting β-agonist) inhaler plus a separate steroid inhaler simultaneously. The formoterol + steroid inhaler is thus preferred over the albuterol only inhaler as a reliever medication.

The U.S. National Institutes of Health’s National Asthma Education and Prevention Program (NAEPP) updated their asthma treatment guidelines in 2020 and made similar recommendation for the use of a formoterol + inhaled corticosteroid combination inhaler for use as both a maintenance and a reliever inhaler in patients with moderate or severe asthma.

Formoterol is a long-acting β-agonist and is the ingredient in the inhaler, Foradil. It is also an ingredient in the combination inhalers Symbicort (formoterol + budesonide) and Dulera (formoterol + mometasone). Budesonide and mometasone are both inhaled corticosteroids. In 2003, the FDA required that all inhalers containing both long-acting β-agonists + inhaled corticosteroids (such as Symbicort and Dulera) include black box warnings in their package inserts. These warnings stated that long-acting beta agonists have been linked to increased death and that Symbicort, Dulera, and all other combined long-acting β-agonist + corticosteroid inhalers should only be used in patients with severe asthma not controlled by an inhaled corticosteroid alone. The black box warnings further specified that these combination inhalers should be discontinued as soon as possible once asthma is controlled. The black box warnings originated because of the SMART trial (Salmeterol Multicenter Asthma Research Trial) published in 2006. In this study, asthmatics were treated with salmeterol (a long-acting β-agonist) or placebo as a sole maintenance inhaler for asthma and the results indicated increased death in patients receiving salmeterol. An important criticism of this study is that patients were not treated with an inhaled steroid, just the inhaled salmeterol. The implication is that subjects in the SMART trial were only treated for bronchospasm and their airway inflammation was left untreated. Nevertheless, due to the SMART trial, the FDA required the black box warning of risk of death for any inhaler containing a long-acting beta agonist, including those in which the long-acting β-agonist is combined with an inhaled corticosteroid. In 2017, the FDA removed the black box warning on these combination inhalers after further studies showed that the combination inhalers were not associated with increased death (unlike the single agent long-acting β-agonist inhalers).

However, the previously required black box warnings have left an indelible imprint on American physician prescribing practices. Despite the removal of these warnings 5 years ago, many physicians remain hesitant to adopt the GINA guidelines recommending that combination long=acting β-agonist + inhaled corticosteroid inhalers be used as rescue inhalers. Furthermore, the use of inhalers such as Symbicort and Dulera as rescue inhalers is still considered off-label in the United States.

To make matters worse, the asthma management strategy of using a formoterol + inhaled corticosteroid combination inhaler as both a maintenance and a reliever inhaler has been referred to by the National Asthma Education and Prevention Program and others as “SMART” (Single Maintenance And Reliever Therapy). This unfortunate use of the term “SMART” to promote the use of a combination inhaler containing a long-acting β-agonist in asthma has been confused by many clinicians with the SMART study published in 2006 that condemned the use of long-acting β-agonists in asthma and resulted in the previous black box warnings. As a consequence, when many physicians hear about “SMART” asthma therapy, they think that this means “…don’t use long-acting β-agonists for asthma”.

The net result is that American physicians are considerably behind the rest of the world when it comes to using formoterol + corticosteroid inhalers as asthma reliever inhalers and instead continue to rely on albuterol-only inhalers. The graph below from the U.S. FDA shows that formoterol (diamonds) has a similar onset of action as albuterol (triangles) but has a longer effect than albuterol.

The pharmaceutical company, AstraZeneca, is now developing the combination albuterol + budesonide inhaler used in the MANDALA study that is currently only known as PT027. A new drug application was filed with the FDA last month for PT027 so we will likely see it commercially available in the United States in the near future. There is reason to hope that the albuterol + corticosteroid inhaler will be better accepted by American physicians as a rescue inhaler than the formoterol + corticosteroid inhalers.

Is this the end of albuterol?

I think the answer to that question is a pretty solid “No”. Albuterol will continue to be used in COPD and the probable high cost of the combination albuterol + budesonide inhaler will be a barrier to widespread replacement of albuterol-only inhalers in patients with asthma.

What about COPD? Albuterol-only inhalers will continue to be used in another obstructive lung disease, COPD. There is a general reluctance to use inhaled steroids in patients with COPD where, unlike asthma, inhaled steroids increase the risk of pneumonia in most COPD patients. Therefore, albuterol-only inhalers will likely continue to be used as reliever inhalers in patients with COPD.

What about mild asthma? The MANDALA study only looked at patients with moderate to severe asthma. There is a very large population of patients with asthma for whom albuterol-only inhalers seem to work well. This includes patients with exercise-induced asthma and asthma that is only triggered when a person inhales something that they are allergic to (such as cat antigens). These asthma patients were not included in the MANDALA study and so we do not know if the combination albuterol + budesonide inhaler works better than an albuterol-only inhaler for them. As a consequence, it is likely that AstraZeneca will only seek FDA approval for PT027 in those patients with moderate or severe asthma and not in those with mild asthma.

What about cost to patients? Once PT027 is approved by the FDA, it will likely be expensive. A generic albuterol inhaler costs about $30 whereas brand name albuterol is about $75 per inhaler. PT027 will probably be priced closer to brand name combination long-acting β-agonists + corticosteroid inhalers. These typically cost about $300 – $400 per inhaler (a generic formoterol + budesonide inhaler costs about $200 per inhaler). Price alone will make albuterol preferred by those asthmatics without prescription medication insurance. Even for those with insurance, high co-pays and high deductibles may preclude widespread adoption of PT027 as the asthma reliever inhaler of choice.

What about employers? Most employers leave the decision about which drugs will be covered by employee health insurance up to the commercial insurance companies. However, employers may want to pressure insurance companies to include PT027 on their health insurance formularies if the 26% reduction in severe asthma flares using PT027 is confirmed. Currently, asthma exacerbations result in a loss of 8.7 million work days and 5.3 million school days every year in the United States. The total cost of these missed work and school days is $3 billion per year. If the 26% reduction in severe asthma flares translates to a 26% reduction in missed work days and missed school days from asthma, then it may be cheaper overall for employers to include PT027 on their insurance formulary, even if they have to pay higher insurance premiums.

What about hospitals? Hospital formularies typically carry albuterol inhalers and for medical-legal reasons, there will continue to be hesitancy for hospitals to adopt the GINA recommendations of a combination formoterol + inhaled corticosteroid reliever inhaler for hospitalized asthma patients as long as this use is considered off-label by the FDA. Presumably, since it contains a short-acting β-agonist, PT027 will get an FDA approved indication as a reliever inhaler, making it more palatable for hospital pharmacies to replace albuterol on their formularies. However, the cost of PT027 (compared to albuterol-only inhalers) may be a barrier for widespread hospital use.

The bottom line is that for those people with moderate to severe asthma who are either wealthy or have superb prescription medication insurance, albuterol inhalers will likely become obsolete. For everyone else with asthma and for those with COPD, albuterol inhalers will be preferred.

June 28, 2022

The occupancy rate of a hospital is the percentage of available staffed beds that are currently occupied by patients. As the number of COVID cases surges this month, we are about to see our country’s hospitals more fully occupied than ever before.

The need to improve hospital financial efficiency has led many hospitals to try to keep their average occupancy as high as possible, often 90% or higher. But if the occupancy rate is too high, then inefficiencies arise that can be just as detrimental to hospital finances as when occupancy rates are too low. One danger of keeping the average occupancy rate too high is that the hospital cannot accommodate unexpected surges in admissions. This has been a significant problem for hospitals across the U.S. during the various case surges during the COVID-19 pandemic and will be even more so in the next few weeks.

What is occupancy? Most hospitals use the “midnight census” to track their occupancy rate. This is the number of patients in a bed at midnight each day. This metric works well for hotels since there is a defined check-out time in the morning and check-in time in the afternoon each day. However, this number can be misleading for hospitals because hotels, hospital admissions and discharges occur at continuously throughout the day and night with the result that the hospital census at noon is almost always higher than the census at midnight as morning admissions start to pile up while afternoon discharges are still occupying beds. As a consequence, a hospital may have 15% empty beds at midnight but have no empty beds at 2:00 PM. Therefore, the midnight census is useful from a financial standpoint but real-time census is more important from an operational standpoint.

It takes more than just a room with a bed… Not only do you have to have a physical place to put patients, but you have to have the nurses, doctors, pharmacists, and respiratory therapists to take care of them. During the COVID pandemic, at any given time, large numbers of these healthcare workers were unable to work due to having COVID themselves, having to isolate because of a COVID exposure, or having to stay home to take care of  child who was unable to attend school due to COVID. A single nurse can only safely take care of so many patients and if that number of patients is exceeded, then patient care can suffer. Moreover, nursing contracts and nursing units often place a limit on the number of patients a nurse can take care of and a limit on the number of hours per week a nurse can work. When the hospital lacks the personnel to care for patients, it has to “block-out” rooms from use.

Not all hospital beds are equal. Hospitals will try to group similar patients on a single nursing unit. This allows nurses to develop expertise in managing specific types of patients, for example, cardiac, pediatric, psychiatric, post-surgical, and maternity. This also creates better efficiency for the doctors so that, for example, a surgeon does not need to go to 7 different nursing units to round on his/her 7 post-op patients. But as nursing units become more and more specialized, it becomes less desirable to admit one kind patient to a different kind of unit. So, for example, having a lot of open beds in the addiction medicine ward does not really help you if you are trying to find a bed for a post-op neurosurgery patient and all of the surgical nursing units are full. Most hospitals will have a lot of “med-surg” units that can accommodate general medical patients or surgery patients.

What happens when there are no beds?

The need to accommodate the constant flow of admissions has resulted in hospitals putting a lot of resources into capacity management. Smaller hospitals often utilize a “nursing supervisor” who keeps up-to-date information on which patients are projected to be discharged and which patients are awaiting admission. Larger hospitals will utilize a admission control center staffed by multiple nurses whose sole responsibility is directing the flow of hospital admissions and patients being transferred from other hospitals; this is called “bed placement”. In most hospitals, the electronic medical record will facilitate this process by having dashboards that list open beds and beds occupied by patients who will be discharged later that day.

But what happens when all of the beds are full and there are more projected admissions than discharges for the rest of the day? That is when the hospital medical director generally gets involved. Here are the some of the available options:

1. Expedite discharges. This is usually the first action taken and involves contacting all of the hospitalists and other attending physicians to ask them to hasten discharges. Most of the time, this only results in moving otherwise planned admissions up by a couple of hours but even that can help free up a few beds to help decompress admission bottlenecks. Simply having a discharge order does not ensure that an empty bed will be created, however. Nursing and case management can also expedite discharges by arranging earlier transportation home, by locating nursing homes with available beds, and by using “discharge suites” where discharged patents can wait for their rides.
2. Focus on long-length-of-stay patients. Every hospital has a group of inpatients that have been admitted for many weeks or months. Often, these are patients who are difficult to get placed in nursing homes because they are uninsured or because they have behavioral problems. By creating  multidisciplinary workgroup to identify and overcome the barriers to discharge of these patients, desperately needed hospital beds can be opened up.
3. Board admitted patients in the emergency department. There are a lot of reasons why boarder patients are undesirable (see my previous post). But in the short run, this is often the easiest way to accommodate a surge in admissions. If the number of boarders in the ER becomes too high, then the ER becomes congested and unable to provide care for regular emergency patients.
4. Board post-surgical patients in the post-op recovery unit. Most patients recover in the recovery unit and then go to a regular hospital room to spend the night (for outpatient surgeries that require overnight observation) or spend several nights (for elective inpatient surgeries). Keeping patients in the recovery room longer can allow extra time needed to get other patients discharged and get those rooms cleaned and ready for the post-op patients. However, at some point, the recovery unit becomes full creating a bottleneck in patient flow in the operating rooms. One solution to this is multi-use space that can serve as pre-op beds in the morning and post-op beds in the afternoons. However, if patients remain in the recovery area into the evening or night, then you have to have the nurses to care for those patients and this either means keeping the post-op recovery area nurses overtime or “floating” nurses from other floors to the recovery area.
5. Stop accepting hospital transfers. This is a tactic that only works for larger referral hospitals that normally have transfers comprise a significant percentage of their admissions. These transfers are usually patients with complex medical or surgical conditions coming from small hospitals that are not equipped to manage them and so these patients still need to be transferred somewhere. If all of the other referral hospitals in the area are also full, this can mean that the patient in a small hospital may need to be transported to a hospital in a far-away city or even another state. During the first surge in COVID cases in January 2021, it was not uncommon for me to get a call about transferring a patient with respiratory failure from a physician in a town such as Defiance, Ohio who had already had his patient turned down for transfer from all of the referral hospitals in Toledo, Dayton, Cincinnati, and Cleveland.
6. Put the emergency department on divert. When the emergency department goes on divert status, emergency squads are directed to take patients to other emergency departments. This is undesirable from a community standpoint because it can result in delays in caring for critically ill patients by having the squads travel to emergency departments that are further away. There are a lot of reasons why an emergency department might go on divert: too many patients backed up in the waiting areas, a bolus of cardiac arrest or trauma patients that temporarily requires all of the available ER staff to manage, a hospital power failure, too many inpatient boarders in the ER, etc. During the COVID surges, there were days when all of the hospitals in Columbus were at full inpatient capacity and all of the emergency departments went on divert – when this happens, the agency that oversees regional trauma care institutes “city-wide divert”. In this situation, the region’s emergency squads go to hospitals on a rotational basis so that all hospitals share the excess patients equally.
7. Cancel elective admissions. This mainly affects surgeries – both elective inpatient surgeries (such as spine surgery) and outpatient surgeries that require an overnight stay (such as knee replacement surgery). Hospital leaders hate to do this because these surgeries are very financially lucrative. The result is replacing a surgery patient that the hospital can make money on with a medical patient that the hospital can at best hope to break even on. In addition, by canceling surgeries, the surgeons and anesthesiologists are idle and the hospital usually ends up paying the salaries for these highly-paid physicians since they cannot earn their income in the operating room.
8. Open up new beds. In a crisis, hospitals can convert many areas of the hospital into emergency-use patient care areas: decommissioned nursing units, the endoscopy suite, the sleep lab, the cardiac cath lab recovery area, etc. There is an inherent inefficiency to using these areas for inpatients as they are not equipped to care for inpatients and the normal nurses for these areas are unaccustomed to regular inpatient care. Also, when these areas are used for inpatients, they cannot be used for their normal purposes and this results in canceling  elective procedures.
9. Create new space. When the hospital has maximized available space within the building, the next step is often to create temporary hospital space . During the initial surge in COVID cases, we erected a large tent in the parking lot adjacent to the emergency department to do triage and care for low-acuity emergency room patients. The Ohio National Guard helped to convert the Columbus Convention Center into a several hundred bed hospital area for low-acuity inpatients (that we fortunately never needed to utilize). Other hospitals converted parking garages, college dormitories, and hotel rooms into temporary patient care areas.
10. Ration healthcare. This is usually done only as a last resort. Although often discussed in the U.S. during COVID surges, it was rarely, if ever implemented in our country. But in underdeveloped nations, this is a fact of daily life. If there are only 3 ventilators in a hospital with no others within several hundred miles, then the doctors have to choose which three patients get to use the ventilators. Even in developed countries, such as Italy, the first surge of COVID resulted in rationing of ventilators and ICU beds to only those patients felt to be most likely to survive.

Where do you find more doctors and nurses?

When hospitals start opening up new beds or new space for inpatients, those beds are only useful if there are doctors, nurses, and other staff available to cover them. During January 2021, we staffed new COVID ICU areas with anesthesiologists, hospitalists, trauma surgeons, and emergency medicine physicians rather than critical care internists. Recovery room nurses, addiction medicine nurses, and cardiac cath lab nurses were sent to staff med-surg nursing units and ICUs. We brought in general internists and family physicians who normally worked in outpatient clinics to function as hospitalists. CMS made an emergency allowance that residents and fellows in training could be temporarily credentialed as attending physicians and were allowed to bill for inpatient services. Many hospitals turned to recently retired physicians and nurses. “Traveler” nurses and locum tenens physicians (frequently from out of state) were often brought in to help with inpatient care.

Currently in Ohio, the governor has deployed the National Guard to the most crowded hospitals to assist. The problem with the National Guard is that most of the doctors and nurses in the National Guard are already tied up caring for patients in their own hospitals during the current COVID surge and so the only members of the National Guard available to help are non-healthcare workers who can only assist with support activities in hospitals.

Keeping up morale

When hospitals run out of beds and operate at full capacity (or over full capacity), it puts enormous strain on the mental health of the healthcare workers: Nurses who are caring for patients with conditions that they are not familiar with. Doctors who are taking care of more patients than they normally manage in a day. Everyone exhausted from working extra shifts. Angry patients and families lashing out at healthcare workers. Experiencing mounting numbers of deaths. All of these contribute to burn out. Even if the hospital administrators can open new physical beds, those beds are useless if the healthcare workers call-off work or quit due to burnout. Also, a toxic doctor or nurse may provide a needed warm body in the short run but will poison the workplace for other doctors and nurses in the long run. Fortunately, there are some things that medical directors can do.

1. Communicate. This is probably the single most important tool that medical directors have to combat staff burnout. Times of crisis create information vacuums and unless hospital leaders communicate regularly, that vacuum will be filled by rumors and conspiracy theories. In-person town hall meetings, virtual Zoom meetings, daily website posts, and emails all have their roles and it is best to use a combination in order to ensure the largest audience possible.
2. Be a cheerleader. More than any other time, during high capacity periods, medical directors and other hospital leaders need to get out of their offices and get into the patient care areas. It is essential that you are visible to the doctors and nurses and show that you are there to serve them. Look for excuses to give compliments. Show up at code blues, STEMI alerts, and trauma alerts. And don’t forget about the night shift staff.
3. Recognize burnout. Knowing the signs of burnout can allow you to intervene early when burnout is still reversible. The worst thing you can do is to deny that burnout exists.
4. Offer help. Counselors and other mental health professionals can help build resilience in the healthcare workers and making them freely available to hospital staff is a must.
5. Offer accommodations. This could be as simple as allowing staff to do non-standard length shifts so that they can be home to take care of children. It could include reserving a block of hotel rooms for nurses who live out of town to stay in order to avoid long-distance commutes.
6. Offer perks. Minor services  such as paying the cost of grocery delivery, Uber rides, baby sitting costs, and laundry services are relatively inexpensive for hospitals but can go a long way toward preventing burnout during times of healthcare worker stress from high inpatient capacity. Periodically buying pizza and cookies is a small measure but shows the staff that you are thinking about them.
7. Pay them. Overtime compensation and bonuses are powerful prevention against disgruntlement. When the hospital is full for prolonged periods of time, it is probably losing money from canceled surgeries, etc. But this is why hospitals maintain a certain number of days cash on hand and the hospital should not be afraid to use those reserves.

U.S. hospitals are about to fill up

As of January 14, 2022, the United States is seeing not only the highest number of daily cases of COVID-19 than at anytime in the pandemic (red line in the graph above) but we are also seeing the highest number of patients hospitalized with COVID (yellow line in the graph above). From experience, we know that hospitalizations do not peak until 2-3 weeks after case numbers peak so our hospitals are only going to become more full before the end of this month. The good news is that the percent test positivity peaks about a week or so before the case numbers peak and the most recent data from the CDC suggests that the percent test positivity is just starting to come down (yellow line in the graph below). If this trend continues, then we should see the case numbers begin to fall within the next week or so.

But COVID does not affect different parts of the country at the same time and many cities and states may not see the peaks in case numbers and hospitalizations for several weeks.

Regardless, we are about to see our nation’s hospitals more full of patients than ever before and each hospital needs to develop plans for how it will get through the next month.

January 16, 2022

Suicide is the master thief. He steals from our family, from our friends, and from those that we admire. These are the faces of some of the lives that he has stolen. Although we have greater fear of his brother homicide, suicide takes more lives each year than homicide. Sometimes, suicide slips into our homes after we’ve feared him, after we thought we locked the doors and closed the windows to keep him out. Sometimes, he catches us off guard and we wake up in the morning and find that he’s stolen a life when we least expected it. He doesn’t discriminate by age or race or gender. He’ll strike the rich and the poor, the famous and the unknown, the strong and the weak. He has preyed on men and women for as long as humans have walked on the earth. Many people turn to him hoping that he can relieve their pain but all together too often, the pain goes on just as intensely in those who are left behind. Sometimes he whispers his intentions in our ears before he comes but all too often, we just don’t hear him or we don’t understand what he is saying to us. As physicians, whether we are primary care providers, emergency room physicians, specialists, or hospitalists, we are often in the best position to hear those whispers and to identify patients who are suicidal early on, when intervention can save lives.

Suicide is an enormous public health problem in the United States. It is the 10th leading cause of death in our country and the 2nd leading cause of death in persons age 10 – 34 years old. One American dies by suicide every 11 minutes. But this is not just a U.S. problem. In fact, the United States has just the 37th highest suicide rate in the world, led by Greenland which has the highest suicide rate at 83 per 100,000 population.

There is a gender paradox to suicide: in the United States, women are 3 times more likely to attempt suicide than men but men are 3.5 times more likely to die by suicide than women. Part of the reason is in the gender differences in method of suicide. Men most commonly use guns and women most commonly use poisoning – firearms are considerably more effective as a means of death than poisoning. Overall, guns account for 50% of all U.S. suicides followed by poisoning at 14%, suffocation at 28%, and miscellaneous other methods at 8%.

There are racial differences in suicide with caucasians having the highest suicide rate at 15.85 per 100,000 population followed by native Americans at 13.42, African Americans at 6.61, and Asian Americans at 6.59 per 100,000. Western states and Alaska have the highest suicide rate. Suicide is increasing – in 2001, the U.S. suicide rate was 10.7 per 100,000 population but by 2017, it was up to 14.0 per 100,000 population – a 30% increase in just a decade and a half.

45% of people who die by suicide saw their primary care physician within a month prior to their death. So what can we do in our office practices and our emergency rooms to identify those patients at risk for suicide and get them the psychiatric care that can save their lives? Fortunately, there are easy assessment tools that we can use that will help identify at-risk patients. There are many suicide screening questionnaires available – two that are commonly used in healthcare settings are the ED-SAFE and the Columbia screening tools.

The ED-SAFE tool (click on the attached images to enlarge) was originated as a National Institutes of Mental Health study performed at 8 emergency departments in the United States to determine the impact of suicide screening in emergency departments. It is available free of charge at the Suicide Prevention Resource Center website. It consists of two parts. The first part is the Patient Safety Screener (PSS-3) which consists of 3 questions and can be administer by nurses doing triage in the emergency department. Patients screening positive on the PSS-3 are then asked questions from the second part which is the ED-SAFE Patient Secondary Screener (ESS-3) which consists of 6 additional questions. The responses to the ESS-3 will stratify patients into (1) negligible risk, (2) low risk, (3) moderate risk, or (4) high risk. The risk categories then provide mitigation and recommended care for patients such as 1:1 observation and use of ligature-resistant rooms.

The Columbia Suicide Severity Rating Scale (click on the attached image to enlarge) was created by Columbia University, the University of Philadelphia, and the University of Pittsburgh with sponsorship by the National Institutes of Mental Health. It is available on-line free of charge at the CSSRS website. It was designed to identify those patients at risk of suicide in general settings and healthcare setting and has been endorsed by the CDC, FDA, NIH, Department of Defense, and other organizations. Based on patients responses to 6 different questions, there are recommendations for either (1) behavioral health referral at discharge, (2) behavioral health consult and consider patient safety precautions, or (3) psychiatric consultation and patient safety precautions.

These screening tools are the first step but frequently, a more detailed suicide assessment is necessary and this may require a more nuanced history from the patient. Major risk factors for completed suicide include:

1. Prior suicide attempts
2. Family history of suicidal behavior
3. Mental illness, especially mood disorders
4. Alcohol or drug abuse
5. Access to lethal means of suicide (especially firearms)

There are other risk factors to consider as well:

1. Caucasian
2. Male
3. Divorce or significant loss
4. Traumatic brain injury
5. Physicians
6. Prisoners
7. History of sexual abuse
8. Recent psychiatric hospitalization
9. Attention deficit hyperactivity disorder (ADHD)
10. Lesbian, gay, bisexual, or transgender
11. Self-injurious behavior

But in addition to risks, there are also protective factors that can sometimes offset suicide risks for individual patients. These protective factors can often make the difference between a patient being at moderate risk or high risk of suicide:

1. Family
2. Pets
3. The person’s individual morals
4. Religious faith

Suicide assessment is not just the purview of the psychiatrist. It is up to all of us: emergency medicine physicians, primary care physicians, hospitalists, and specialists. In an era when a hip replacement surgery costs $32,000 and immunotherapy for lung cancer with the drug nivolumab costs $150,000/year, we could save thousands of lives at the cost of just asking a few questions.

November 9, 2019

The EMTALA law was enacted 33 years ago as an “anti-dumping” law. EMTALA fundamentally has 2 main implications for the hospital: how you manage patients in the emergency room and how you manage hospital transfers. It stands for the Emergency Medical Treatment and Active Labor Act and it placed requirements on hospitals receiving Medicare payments; because almost all hospitals accept Medicare, in practice, it affects nearly all U.S. hospitals.

There are 3 obligations that hospitals have under EMTALA:

1. The emergency department must provide a medical screening exam to any patient who requests emergency care, regardless of their health insurance status, their ability to pay, or their citizenship.
2. If the medical screening exam indicates that the patient has an emergency medical condition, then the hospital must provide treatment until the condition resolves or stabilizes and the patient can provide self-care after discharge.
3. If the hospital does not have the capability to treat the patient’s condition, then it must make an appropriate transfer to another hospital that has the capability of treating the patient’s condition and provide medical records to the accepting hospital. Hospitals with specialized capabilities must accept these transfers and provide treatment.

Why did EMTALA come to be?

In the 1980’s, some hospitals and doctors flat out refused to treat patients in their emergency departments if the patients could not pay. Other hospitals would transfer unstable patients to public hospitals without doing even a basic medical assessment or providing initial treatment to stabilize patients. Physicians at Cook County Hospital in Chicago reported that 87% of patients transferred to their hospital were sent because they lacked health insurance, only 6% of those patients actually gave written consent for transfer, and 24% were transferred in medically unstable condition. Thus emerged the term “patient dumping”. A 1985 exposé on the CBS news show 60 Minutes titled “The Billfold Biopsy” helped raise public awareness of the national scope of the problem.

But if you look a bit closer, EMTALA was, at least in part, designed to protect Medicare patients. Three years earlier, congress had enacted legislation that created DRGs, meaning that hospitals got paid based on the diagnosis rather than being paid based on charges. Legislators were concerned that hospitals would try to game the DRG system by providing substandard care to reduce costs in order to profit by DRG payments by Medicare. EMTALA directly addressed this by requiring hospitals to provide the same emergency care to patients whether they had commercial insurance or Medicare/Medicaid.

What about free-standing emergency rooms?

EMTALA applies to hospital emergency rooms, whether they are physically part of the hospital building or geographically separated from the hospital. In the past 15 years, there has been a nationwide proliferation of free-standing emergency rooms that are located many miles away from its parent hospital, generally in suburban areas. When asked why he robbed banks, Willie Sutton famously said “Because that’s where the money is”. So why do hospitals build satellite emergency departments in the suburbs? Because that is where the money is – lots of commercially insured patients with relatively fewer Medicaid and uninsured patients. These outlying emergency rooms can serve as conduits to direct well-insured patients needing profitable surgeries or inpatient admissions to the host hospital. This type of free-standing emergency room is subject to EMTALA requirements just as if they were physically attached to the host hospital.

There is a second type of free-standing emergency room. These are privately-owned and not associated with a local hospital. Currently, there is uncertainty about whether these facilities fall under the EMTALA requirements and there are state-specific laws and legal precedents about whether or not they must adhere to all of the elements of EMTALA. However, since these emergency rooms are not associated with a hospital, they cannot provide inpatient treatment for emergency medical conditions and so the emergency room physicians can transfer a patient requiring inpatient care to any hospital they choose.

What are the implications for physicians?

The focus of EMTALA was initially on emergency room physicians – that they must do a medical screening exam and provide basic emergent care to all patients. However, when I am on call at night for our intensive care units, EMTALA also applies to my decision making. As a tertiary care medical center, our ICU has the capability of providing a higher level of care than most other ICUs in the region. Many hospitals lack critical care physicians, infectious disease specialists, cardiothoracic surgeons, and other specialists. Because we have residents, nurse practitioners, and fellows in our various ICUs at night to handle most patient care-related calls, the most common calls I get are from other hospitals asking about transferring patients to our medical intensive care units. If we have empty ICU beds, we are usually obligated to take those critically ill patients. However, despite EMTALA being decades old, I am still called by outlying emergency room physicians about transferring uninsured patients purely because the physician considers ours to be a charity hospital since we are a state-supported university. It can often be a fine line to walk: we are obligated to accept in transfer any patient whose medical needs cannot be met at these outlying hospitals but we are not obligated to accept patients simply because they are uninsured. Experienced attending emergency room physicians know about EMTALA requirements but the questionable calls most commonly come from residents in training or junior attending physicians in ERs at hospitals that are part of a larger healthcare system that includes tertiary care hospitals. These less-experienced physicians often do not realize their (and their hospital’s) requirements under EMTALA and as a consequence, “patient dumping” to academic medical centers still occurs.

Overall, EMTALA has improved the care to vulnerable patient populations. But EMTALA is still just as important today as it was 33 years ago and it is incumbent on us to insure that our emergency room physicians, our hospitalists, and our critical care physicians understand EMTALA’s implications for their clinical practices.

October 28, 2019

When the average person thinks of donating blood, the first words that come to mind are “Red Cross”. However, the American Red Cross only supplies about 40% of transfused blood in the United States. What most people don’t realize is that the U.S. uses a free-market approach to maintain its blood supply with the result that there are dozens of different blood suppliers for our nation’s hospitals and they compete with each other.

Every day, 35,000 units of packed red blood cells, 7,000 units of platelets, and 10,000 units of plasma are transfused in the United States. In order to meet the needs, there has to be a continuous flow of donated blood into the country’s blood banking system because blood has a short self-life: 42 days for red blood cells and 5 days for platelets. However, red blood cells can be frozen for up to 10 years.

Most countries use a single, government-directed supplier for the blood supply but the U.S. utilizes a network of non-profit blood services that are overseen by federal regulations. As of 2016, there were 786 registered blood establishments that collect blood plus 725 hospital and non-hospital blood banks. Blood centers account for 93% of all collected blood and hospital blood banks account for 7% of collected blood.

We do not transfuse as much blood as we used to. Lower transfusion thresholds (from previous thresholds of 8-9 g/dL hemoglobin to current thresholds of 7 g/dL), a trend toward less-invasive surgeries, the increased use of erythropoietin, hospital blood management programs, and improved medical technology have led to a reduced utilization of blood; the number of units transfused has dropped by 25% since 2008. As the demand for blood has fallen, there has been more competition between the various blood suppliers and many suppliers have gone out of business. So, who are all of these blood suppliers?

• The American Red Cross. This is the most visible and publicly recognizable blood supplier and accounts for about 40% of the nation’s blood.
• America’s Blood Centers. This is a network of more than 50 independent, local blood suppliers that supply about 50% of the nation’s blood. Its member organizations manage more than 600 donation sites in 45 states. Two of the largest members are Vitalant (western United States) and Versiti (midwestern United States).
• The Armed Services Blood Program. This supports the military and their beneficiaries.

Blood is a unique commodity in that it is almost entirely donated for free by volunteers. The cost of blood is therefore primarily due to the expense of processing, storage, and distribution. Hospitals will typically contract with a particularly blood supplier based on (1) per-unit cost to the hospital and (2) quality of service from the blood supplier. Because of the declining demand for blood and because the U.S. has experienced a period of hospital consolidation into large hospital systems that can compete aggressively for blood pricing, the financial margin for most blood centers are razor thin and many operate at an annual financial loss.

Because 92-95% of blood is transfused into hospital inpatients, the cost of blood is absorbed into the hospital’s general expenses rather than being passed directly to the consumer (i.e., the patient). This is because hospitals are paid by a DRG price that is fixed based on an inpatient’s diagnosis and the hospital gets paid the same whether 1 unit of blood is transfused or 20 units of blood is transfused. Most blood is sold on a consignment model – the hospital stores blood but only charges the blood centers for the units actually transfused; therefore, the blood centers bear the cost of outdated units. The net result is that the blood suppliers are happy when more blood is transfused and the hospitals are happy when less blood is transfused. The average price paid from hospitals to blood centers in 2013 was $225 per unit.

About 38% of the U.S. population is eligible to donate blood but only a fraction of eligible persons actually donate. All blood is subject to testing for communicable diseases including:

• Hepatitis B surface antigen (HBsAg)
• Hepatitis B core antibody (anti-HBc)
• Hepatitis C virus antibody (anti-HCV)
• HIV-1 and HIV-2 antibody (anti-HIV-1 and anti-HIV-2)
• HTLV-I and HTLV-II antibody (anti-HTLV-I and anti-HTLV-II)
• Serologic test for syphilis
• Nucleic acid amplification testing (NAT) for HIV-1 ribonucleic acid (RNA), HCV RNA and WNV RNA
• Nucleic acid amplification testing (NAT) for HBV deoxyribonucleic acid
• Antibody test for Trypanosoma cruzi, the agent of Chagas disease

The most common blood type is O+ followed by A+. People with type O- blood are known as universal donors because anyone can received type O- red blood cells. Persons with type AB+ are known as universal recipients because they can receive blood of any type. Like 9% of Americans, I’m B+ so I can receive blood from people with blood types B+, B-, O+, and O- (in other words, 59% of of the population); I can donate blood to people with blood types B+ and AB+ (in other words, 13% of the population). There are differences in blood types between countries and between racial/ethnic groups. For example, 11% of South Koreans are AB+ (universal recipients) whereas only 0.5% of Ecuadorians are AB+. On the other hand, only 0.1% of South Koreans are O- (universal donors) whereas 11% of people in the United Kingdom are O-.

On my 16th birthday, the first thing I did the day I got my driver’s license was to drive to the American Red Cross blood donation center to give blood. Except for a few years during residency and fellowship (when I was regularly exposed to HIV secretions and blood in the ICU), I gave blood every 2-4 months for the next 40 years. About 3 years ago, the Red Cross raised the minimum hemoglobin necessary to donate blood and I found myself too anemic to donate. After anemia tests showed iron deficiency and a work-up for GI bleeding was negative, the conclusion was that I donated too frequently and didn’t eat enough meat. So, I started taking iron supplements for a week before and after blood donations, cut back my donation frequency to every 4 months, and learned to love grilled ribeyes again.

The average donor is male, married, college-educated, with an above-average income, white, and between the ages of 30-50. However, 45% of donors are over age 50. So there is a great need to recruit younger people into the donation pool as the current donor pool ages out. In addition, given the ethnic and racial differences in blood types, there is a need to ensure that our nation’s blood donor demographics more closely represents the nation’s ethnic and racial demographics  so that tomorrow’s blood supply optimally meets tomorrow’s blood demands. We need to eliminate the current disparities that exist in blood donation.

Our nation’s blood supply is a business but a business that is a unique hybrid of volunteers and commercial enterprises that is like no other business in the world. The dynamics of our blood supply is changing based on changes in healthcare financing and some healthcare experts believe that the blood supply system as we currently know it is in peril. But regardless of the changes in economics, patients will still need blood and volunteer donors will still be the ultimate suppliers of that blood. So what am I going to do about it? I do what I’ve always done. I’ll take iron supplements for the next few days and then donate a pint.

May 8, 2019