Categories
Outpatient Practice

Telemedicine Across State Lines?

Healthcare providers and patients have embraced telemedicine during the COVID-19 outbreak as a way to ensure on-going medical care while minimizing potential exposure to the virus. But many of my patients live outside of Ohio, so can I use telemedicine to care for them? Unfortunately, the answer is probably not.

“The practice of medicine is deemed to occur in the state in which the patient is located.”

 

Physician medical licenses are state-specific. Therefore, a physician must have a medical license issued by the state medical board in each state that physician practices in. But if the physician is in one state and the patient is in another state during a telemedicine encounter, which state is the medical practice location? The State Medical Board of Ohio, like most other states, defines the location of the practice of medicine to be where the patient is physically located, not where the doctor is physically located.

So, if a patient from West Virginia comes to see me for a face-to-face visit in my office in Columbus, Ohio, the practice of medicine occurred in Ohio. But if I did a telemedicine visit with that patient while the patient was in their home in West Virginia, the practice of medicine occurred in West Virginia. And since I only have an Ohio medical license, I would technically be practicing medicine without a license.

Each state has different laws about medical licensure

 

In Ohio, the laws pertaining to telemedicine are derived from section 4731-11-09 of the Ohio Administrative Code that applies to the prescription of medication. This law states that a physician cannot prescribe any controlled or non-controlled medication to a patient unless that physician has conducted a physical examination of that patient. However, an exception exists if the following criteria are met:

  • The physician establishes the patient’s identity and location
  • The patient provides informed consent for treatment
  • The physician completes a medical evaluation
  • The physician establishes a diagnosis and treatment plan
  • The physician provides appropriate follow-up recommendations
  • The physician documents the encounter in the medical record
  • The physician uses appropriate technology sufficient to conduct the encounter

The State Medical Board has stricter rules regarding the prescription of controlled substances, such as opioids. If a physician has never conducted a physical examination on a patient, the physician cannot prescribe controlled substances except in a few situations, such as the physician is cross-covering for another physician who has examined the patient or if the patient is in hospice.

Physicians outside of Ohio who want to provide telemedicine care for patients who live in Ohio must obtain an Ohio telemedicine certificate (at a cost of $350) and are held to the same standard of care as a physician having a regular Ohio medical license.

The COVID-19 emergency has changed state telemedicine regulations

 

Each state has responded differently to telemedicine regulation changes brought on by the COVID-19 outbreak and each state’s requirements are summarized on the Federation of State Medical Boards’ website. For the State Medical Board of Ohio, there were 2 concessions made for physicians outside of Ohio for the duration of the COVID emergency:

  1. They are able to provide telemedicine services to their established patients who were visiting Ohio and now unable to return to their home states due to COVID-19.
  2. If they are in a contiguous state to Ohio and have established patients who live in Ohio they can also provide telemedicine service to those patients.

In addition, the State Medical Board of Ohio has suspended the requirement that a physician must have performed a physical examination in order to prescribe medications and suspended the requirement for in-person visits to occur for the prescription of controlled drugs, such as opioids.


But the regulations are often very confusing. For example, during the COVID-19 emergency, West Virginia permits a physician licensed in any other state to provide telemedicine to patients located in West Virginia. However, Ohio has not made similar concessions permitting an Ohio-licensed physician to perform telemedicine visits with a patient located out of state. So, the question remains, can a physician licensed in Ohio perform telemedicine to a patient in West Virginia? The State Medical Board of Ohio says no whereas the State Medical Board of West Virginia says yes. This has important implications for malpractice insurance coverage in that if a physician’s medical license does not cover their telemedicine encounter in another state, their malpractice coverage may not cover that telemedicine encounter, either.

So what is a physician supposed to do?

 

The safest bet is to obtain a medical license in all of the states that your patients live in. This would also include states that your patients vacation in if you want to provide care for them by telemedicine if they get bronchitis while visiting relatives out of state. During the COVID-19 emergency, check with the State Medical Board of both the state that the physician is in as well as the state that the patient is in to be sure that both states permit out-of-state telemedicine.

For my own practice, I encourage my patients in Ohio to use one of our telemedicine options. For my patients in other states, I tell them they have to have travel to Columbus and have an in-person visit in my office.

July 25, 2020

Categories
Outpatient Practice

Optimizing Telemedicine Into Outpatient Clinical Practice

The medical field has been dabbling in telemedicine for decades but until now was held back largely by reimbursement. Quite simply, Medicare and insurance would not pay for it except in a few very specific situations. But COVID-19 has opened the door for broad adoption of telemedicine into regular outpatient practice. When COVID-19 first emerged in the United States, Medicare allowed physicians to see patients via telemedicine and get paid the same as they would have if they had seen patients in a regular physician office. Although the future of telemedicine is subject to the vagaries of Medicare decision-making, my suspicion is that it is now here to stay – Americans have tried it and they like it.

Being old-school, I believe in the value of a well-performed physical examination and so telemedicine is not going to replace all office visits. For some specialties, for example wound care, telemedicine may only be able to be used in a minority of visits. However, not every office visit requires a physical examination – in my practice, I believe that I can do about one-half to two-thirds of my office visits by telemedicine and deliver the same quality of medical care. But with a mixture of in-person and telemedicine visits, how does a physician most efficiently design their schedule templates? As I am setting up my own templates, I’ve found that there are several factors to consider.

Patients like telemedicine

With telemedicine, patients no longer have to take several hours off of work to travel to and from the doctor’s office. For patients like many of mine who are on home oxygen, they don’t have to worry about their oxygen tank running out during the trip to  the doctor’s office. Patients who live a hour or two away from the doctor can now see their doctor without having to travel to the city that their doctor practices in. And patients don’t have to endure the aggravation of waiting in a crowded waiting area for the doctor who is running behind schedule. With COVID-19, patients don’t have to fear going out of their homes to a place where they could become infected by someone with the virus.

Telemedicine-only schedules

Most physicians think in terms of half-day templates. In my own practice, I take care of administrative and teaching responsibilities in the mornings and then see outpatients in the afternoons. By making an afternoon telemedicine-only, a physician can greatly reduce overhead cost. You don’t have to pay for rent for examination space and the office staff can do patient registration, medication list confirmation, etc. anytime that day or even the day before so that their time can be utilized more efficiently. The physician does not even have to be physically in the office – he or she can be in the hospital or even at home. This frees up the office space for another physician to use it for in-person visits.

Another advantage of telemedicine-only schedules is that by giving the patient a time range that the physician will contact them for the telemedicine visit (for example, between 1:00 – 2:00 PM), the patient does not need to sit in the exam room waiting for the doctor, they can be in the comfort of their own home or workplace. This way, if the physician is running a few minutes late because the previous patient took longer than anticipated, patients are less likely to become angry from long waiting times.

The disadvantage of telemedicine-only schedules is that the physician has to have enough days that they see outpatients so that some days can be devoted to in-person visits since there are inevitably some patients who must be seen face-to-face. So, if a physician has a very small outpatient practice, this approach is not practical.

Combining telemedicine and in-person schedules

In this strategy, the physician intersperses in-person visits with telemedicine visits. An advantage of this strategy is that the physician needs fewer examination rooms – a doctor who normally uses 4 exam rooms to optimize outpatient practice efficiency may only need 2 or 3 exam rooms. This can cut down on overhead costs. If the doctor gets behind on the schedule, then the doctor can postpone a telemedicine visit by 20 minutes and see the patient already in an examination room – by and large, patients waiting in their own home will be less irritated if the doctor is 20 minutes late for the telemedicine visit than the patients waiting in an exam room or waiting room. Additionally, telemedicine visits generally take a few minutes less than an in-person visit (no physical exam) so alternating telemedicine visits with in-person visits helps keep the doctor on-time for all of the patients.

In the COVID-19 era of social distancing, physician office waiting areas are not able to safely hold as many people as in the past. By mixing telemedicine and in-person visits, the number of people coming into the office is lower and this results in fewer people in the waiting area. Mixed visits on the schedule also give office staff extra time needed to sanitize exam rooms between patients.

The fate of in-person-only schedules

Until 3 months ago, this was the model used by most U.S. physicians. The result was crowded waiting rooms, irritated patients when the doctor was running behind, and the expense of no-show patients. This model is inefficient and costly. It places high demands on office staff and the physician to keep the schedule on time. In the future, this will probably not be a financially viable method of seeing patients.

So how should you structure your schedule templates?

There is no single best answer and template optimization depends on the medical/surgical specialty, the number of half-day blocks of office hours an individual physician has, and how COVID-19 is affecting the community at any given time. My recommendation would be to:

  1. First, create half-day blocks of mixed telemedicine + in-person office visits. Depending on the size of the waiting room, the number of exam rooms per physician, and the practice specialty, this could be 2:1 telemedicine:in-person or perhaps 1:1 telemedicine:in-person visits.
  2. Second, create half-day blocks of telemedicine-only visits. For many physician practices, this will be approximately 1/3 or 1/4 of the total half-day blocks.
  3. Have more than 1 telemedicine software application that your office uses and educate your patients on how to use the app. Many of the video chat programs currently being used for telemedicine require a specific web browser or a specific cell phone operating system. Also, many of these programs require the patient to update to the latest version of web browser software. In order to accommodate the largest number of patients, have 2 or 3 available options for telemedicine video conferencing in order to tailor each patient’s web browser or operating system.
  4. Know your patients’ technologic limitations. A surprisingly large number of patients do not have a computer or phone with a camera or live in an area where there is insufficient internet bandwidth or cell service to do video telemedicine visits. These patients will need to be scheduled for in-person visits.
  5. Be aware of state-specific rules regarding out-of-state telemedicine visits. Many states have eased regulations in the COVID-19 era but most normally have restrictions about medical licenses being valid only for telemedicine visits performed within that state and not for visits when the patient is in another state. These patients will need to be scheduled for in-person visits.
  6. Train the office staff on how to instruct patients to use the video chat telemedicine app. When we first started using telemedicine at the beginning of the COVID-19 outbreak, I would frequently wait for 5-10 minutes for a patient to join the video visit and then I would have to call them on the phone to talk them through using the applications. Ideally, the office staff should do this before the physician video visit with a practice video visit so that the patient becomes familiar with how to use the program.

Telemedicine is (hopefully) here to stay and promises to improve the efficiency of outpatient practice, reduce no-show rates, and provide care to patients who otherwise would not be able to travel to see the doctor. Creating the right schedule template will allow the physician to function with maximal efficiency and generate maximal patient satisfaction.

June 23, 2020

Categories
Outpatient Practice

Is It Safe To Go To Your Doctor’s Office During The COVID Outbreak?

In March 2020, outpatient medicine as we previously knew it changed, perhaps forever. The COVID-19 outbreak was accelerating in the United States and by the beginning of June, it would kill more than 100,000 Americans. People self-isolated in their homes, businesses shut down, and hospitals prohibited visitors. Patients were scared to go to their doctor’s offices and doctors were scared to be in their offices with patients.

In Ohio, the Governor and the Director of the Department of Health issues orders to stop elective medical testing and procedures. Medicare eased restrictions on telemedicine so that patients could still see their physicians without risking exposure to the virus in the doctors’ offices. All of a sudden, it wasn’t safe to go just about anywhere.

Today, our state’s medical practices and hospitals are opening back up for regular medical care and procedures. But the virus is still in our communities and is still causing hundreds of deaths per day. So, is it safe to go to your doctor’s office or to your hospital for an elective surgery? As usual, the answer is… it depends.

In the era of COVID-19, the moment we step outside of our homes, everything we do is a calculated risk. Going to the grocery store for on-line ordering with curbside pick-up is relatively low risk. Going to a sold-out concert and spending 4 hours in a mosh pit is relatively high risk. In our community, many people have died because they got infected with COVID-19 but many others have died because they stayed home in fear of the virus rather than going out to get needed medical care. So, how do you know if it is safe to go to your doctor’s office? Fortunately, there are several things that you and your doctor’s office can do that will improve the safety of patients coming in for medical care.

  1. Limit visitors. The risk of getting infected with COVID-19 increases with the more people you have close contact with. By limiting visitors, there will be fewer people in the building and statistics will be in your favor. Ideally, there should be no visitors except for those necessary to accompany patients with impairments.
  2. Screen everyone entering the building. This means asking if people have had contact with persons known to be infected with COVID-19, if they have fever, or if they have cough. Ideally, everyone entering the building should have their temperature checked at the entrance.
  3. Provide masks. The main reason for non-medical people to wear a mask is to prevent them from infecting others – wearing a mask does less to help keep you from getting infected yourself. When I go to a store, I wear a mask to protect everyone else from me, not to protect myself from everyone else. Buildings where everyone else is wearing a mask are buildings that are safer for you to enter.
  4. Improve throughput efficiency. The less time that a person is in the building, the lower their potential exposure risk. Strategies can include pre-visit registration on-line, reducing time spent in waiting areas, and minimizing time between tests and the doctor’s appointments (for example, the time between a doctor’s appointment and getting an x-ray in the same building).
  5. Safe waiting rooms. Most doctors’ offices and hospitals have waiting rooms that are designed to fit the largest number of people comfortably in the smallest space possible. In the era of COVID-19, there should ideally be 6 feet between people in the waiting areas. This means that most waiting areas should only hold about a quarter of the number of people that the same waiting areas held in the pre-COVID-19 era. Waiting areas can be restructured by removing chairs and by putting up plexiglass or other barriers between chairs.
  6. Don’t shake hands. Almost overnight, the handshake has gone from a welcoming greeting to a threatening gesture.
  7. Go before you go. The fewer doorknobs, handles, and buttons that you have to open, press, or push, the lower your risk of acquiring the COVID-19 virus if the person before you opened that door, pressed that toilet handle, or pushed that elevator button. Use the restroom before you leave home.
  8. The smell of disinfectant is perfume to your nose. If the exam rooms smells like fresh bleach or alcohol-based disinfectants, then the office staff are likely sanitizing that room between patients. That will make chair hand rests, examination tables, and counter tops safer for you to touch.
  9. Use telemedicine. Sometimes, an in-person visit with the doctor is necessary. A physical examination may be required. Maybe you need a vaccination, a blood draw, or an EKG. However, many (and maybe most) doctor’s visits can be done by video visits or even telephone visits. Currently, Medicare and many insurance companies are relaxing restrictions on telemedicine so that doctors can get paid to do telemedicine visits whereas in the past, those insurance companies would only pay for face-to-face office visits. If you can get everything accomplished by a telemedicine visit from the safety of your own home, then do so. A side benefit of telemedicine is that if the doctor is doing two thirds of the visits by telemedicine, then there will be fewer patents in the waiting area and fewer patients in the building thus making it safer for those patients who do require an in-person visit. Because I care for patients with COVID-19 in our hospital’s ICU, I am sensitive to the fact that many of my outpatients would rather not be in the same room as I am on the outside chance that I could have picked up the virus and either be asymptomatically shedding it or be in the incubation period before full-blown infection. Therefore, even if my patients have to come in for pulmonary function tests or x-rays, I will still offer them a telemedicine visit so that they can come in, get their tests, go home, and then have a telemedicine visit with me later.
  10. Schedule acutely sick patients for the end of the day. In the past, I often used the last appointment of the afternoon for those patients who I anticipated would need extra time for counseling – that way, if I spent 30 minutes for a 15 minute appointment, I wouldn’t be behind on my schedule for all of the subsequent patients. Now, I’d rather have that last patient of the day be the one who has more acute respiratory symptoms so that most of the other patients are out of the building and the waiting area when a patient who could potentially have COVID-19 shows up.
  11. Show up on time but not too early. If your appointment with your doctor is at 11:00, don’t come to the office at 10:00 or you will have to wait in the waiting area for an hour. But don’t be late either since you might then have to wait an hour or two until the doctor has another opening on his/her schedule to fit you in.
  12. Hand sanitizer everywhere. Ideally, there should be alcohol-based hand sanitizer in waiting areas, hallways, offices, and exam rooms so that office staff and patients can sanitize their hands as often as possible.
  13. Keep COVID-19 patients away from other patients. Most patients with COVID-19 are treated as outpatients but they still need regular medical care. Our medical center has drive-up swabbing stations to safely test patients for COVID-19 infection in their own cars and we also can do blood draws at these sites so that patients with known COVID-19 infection can get regular blood tests, such as INR levels if they are on anticoagulants. This keeps patients with COVID-19 pneumonia from having to go to the clinic lab to get those blood draws and thus keeps them away from healthy people.
  14. Don’t touch your face. One of the side benefits of wearing a face mask is that it will keep you from subconsciously touching your mouth or nose after you have touched a surface that harbors the virus. If you need to blow your nose  or sneeze, use hand sanitizer both before and after you use a tissue.

Most hospitals and physician offices are actually fairly safe, as far as COVID-19 is concerned. There is heightened attention to infection control, hand sanitizing, and masking that is not as universally practiced at other venues such as stores, gas stations, and public spaces. That being said, there are steps that both the doctors and the patients can take that can make outpatient visits even safer.

June 6, 2020

Categories
Epidemiology Outpatient Practice

Setting Up A COVID-19 Testing Station

In the era of COVID-19, there is a surge in demand for outpatient testing for the virus. When doing tests for regular influenza, patients generally come into their physicians offices and get a nasopharyngeal swab for a flu test in the physician’s office. But with COVID, it is necessary to reduce contact of suspected patients with other patients as well as with office staff. Furthermore, testing requires specialized masks, face shields, and disposable gowns that are generally not available in regular physician offices.

To meet the demand for testing while protecting our healthcare workers and community, we developed drive-up “swabbing stations” to do the tests. The goals were to minimize the time that patients were present in the testing area and minimize the staff exposure to the patients.

The challenge is that in order to track, log, and report tests, a patient must first go through a registration process. Furthermore, in a time of shortages of testing materials, testing needs to be limited to only those people who really need to be tested and not asymptomatic people who are anxious about the pandemic.

Our process was to establish a COVID-19 call center. Patients with symptoms contact their physician who then transfers or directs the patient to the call center. Volunteers in the call center ask the patients scripted questions to determine who requires testing and who does not require testing. Patients meeting testing criteria are registered in the electronic medical record and an order is entered for the test. That order is routed to the patient’s physician, or if the person does not have a physician, it gets routed to a designated physician in our health system – as the medical director our hospital, that often means me.

Patients are told to drive to a specific location and look for innocuous colored signs with arrows labeled with non-specific wording so as to not attract people who just show up without being screened and registered over the phone. They pull their car up to the testing station and a nurse with proper personal protective equipment comes to their window, confirms their identity, performs a nasopharyngeal swab, and the patient drives off. Patients who appear ill are directed to go to the emergency department; others return to their homes.

At our hospital, we chose a side entrance with a covered entryway that in past years led to the emergency department entrance but now is used as a drive-up/drop-off area for ambulances to bring hospital transfer patients to our hospital. We set up a second swabbing station in a parking lot on the University campus that was vacated with University classes all being converted to on-line during the outbreak. This second swabbing station was created using a portable enclosed tent with the ability of several cars to pull up simultaneously on either side of the tent.

The process is that once the patient is registered into the electronic medical record and the order is placed by the call center staff, the patients drive into the swabbing station and call the swabbing station phone number. Staff in the interior of the hospital entrance then print up patient labels for the specimens, pre-label the specimen tubes and then pass those tubes out to the nurse wearing personal protective equipment. That nurse goes to the car window and obtains the nasopharyngeal swab. The patient drives away and the nurse comes into the building and deposits the tube containing the swab into a plastic isolation bag held by another hospital staff member wearing PPE. Another staff member then takes the specimen to the lab for the test to be sent out to a commercial lab (we are currently doing tests on inpatients and employees with our internal hospital test and sending out the outpatient tests to a commercial lab).

I called one of the patients who tested positive over the weekend. She and her husband had returned from a trip overseas the week before. Her husband had mild cough and low grade fever that had since resolved. She had a bit more cough and fever to 101. Because the test takes a few days for the commercial lab to run, by the time her test came back, she was already recovering and no longer had fever or cough. She commented on how smooth and efficient the process went and how upbeat and encouraging the swabbing nurses were.

In Central Ohio, we are still early in the outbreak and the virus is not as prevalent as other parts of the world. Thus far, we have performed 3,000 tests, 1,146 of which have which have been completed. Of these completed tests, we have had 50 positive tests meaning that 4% of tests are positive and 96% are negative. We expect this to change in the next 2 weeks.

March 24, 2020

Categories
Medical Economics Outpatient Practice

Prior Authorizations, Insurance Denials, and Physician Burnout

Insurance denials and insurance prior authorizations are the bane of existence for any physician who practices in an outpatient setting. The are at best an annoyance but last Friday, I had an experience that nearly made my head explode. At issue was the denial of a high resolution chest CT that I had ordered several months ago for a patient with interstitial lung disease who had deteriorating pulmonary function tests despite treatment. I wanted to determine if his interstitial lung disease was worsening to decide if his treatment needed to be changed or if he needed to be referred for a lung transplant. I entered the order into our electronic medical record with ICD-10 code J84.9 (interstitial lung disease) and typed into the “reason for the test” box that he had interstitial lung disease of uncertain cause with worsening pulmonary function tests. The patient’s insurance company contracts with a radiology test benefits management company (which I am going to call “Roadblock, Inc” so that the real company does not blacklist me) to review orders for radiology tests and then approve or deny the tests based on whether or not the tests meet evidence-based indications for that particular test. Last week, shortly before the CT was scheduled to be performed, I got an email from our office staff that the insurance company had called to tell us that Roadblock, Inc had denied the CT and then left a case reference number and the phone number at Roadblock, Inc for me to call. Here is a summary of my subsequent phone call to Roadblock, Inc:

  • 2:00 PM – I call Roadblock, Inc and am on hold for 2 minutes
  • 2:02 PM – A Roadblock, Inc customer service representative answers the call and takes down all of the information about the patient and the test that was ordered
  • 2:04 PM – She transfers me to the clinical review department. I am again placed on hold for 1 minute
  • 2:05 PM – A second customer service representative answers and again asks for the case number, patient’s name and birth date as well as my name and contact information. She informs me that the reason for denial is that the only approved indication for a high resolution chest CT is interstitial lung disease or worsening pulmonary function tests. She asks me if I would like to be transferred to the physician appeals department. I answer yes and am placed on hold for 2 minutes
  • 2:08 PM – a third customer service representative answers and I am again asked for the case number, patient name, and date of birth as well as my name and contact information. She asks me if the previous customer service representative told me why the CT was denied and I answered yes. 
  • 2:10 PM – I explained that the original order had the correct ICD-10 code for interstitial lung disease and additionally had the typed clinical information that the patient had interstitial lung disease with worsening pulmonary function tests. I pulled up the original date-and-time-stamped order from a few months earlier to confirm this and offered to fax it to her. The customer service representative stated that when the order was processed by Roadblock, Inc, that the indication for the test was not completed. I explained that the information that we sent to Roadblock, Inc included the correct ICD-10 code and the correct written indication for the test.
  • 2:13 PM – I then ask to schedule a “peer-to-peer” phone call with one of their physician reviewers. The customer service representative tells me that a peer-to-peer is not permitted for a test denial. The customer service representative acknowledged that the information that I had entered into the order and sent to Roadblock, Inc was the correct indication for a high resolution chest CT but that on the Evicor computer system, that information had not been documented and therefore the test had been denied.  
  • 2:16 PM – I asked for an appeal since the error was on the part of the Roadblock, Inc’s employee who had recorded the information that our office had sent to them. The customer service representative tells me that she is sorry but that appeals are not permitted. 
  • 2:18 PM – I tell her that I would send in a new order for the CT scan. She tells me that I am not permitted to re-order a CT when the original order is denied. She tells me that Roadblock, Inc’s policy is that I cannot order a new CT scan for a 2 month period after a denial. 
  • 2:20 PM – I ask to speak with her supervisor. She tells me that I can call the insurance company to see if they will make an exception to the denial. 
  • 2:21 PM – My head explodes and I tell the customer service representative that her company has failed this patient.

This is not a unique experience. Prior authorizations and denial appeals take up an enormous amount of physician and office staff time. A recent survey of 1,000 physicians by the American Medical Association found that 91% reported that the prior authorization process had a negative impact on patient care; 28% reported that prior authorization had resulted in delays of care that resulted in hospitalization, death, or disability; 86% reported that the prior authorization process placed a high or extremely high burden on their practice; and 88% reported that the prior authorization process has gotten worse in the past 5 years.

The Council for Affordable Quality Healthcare found that prior authorizations increased 27% between 2016 and 2019. Currently, the average physician has to do 34 prior authorizations per week and the total time cost to the physician and office staff is 14.9 hours per week devoted just to prior authorizations.

About 25 years ago, our pulmonary practice group held an all-day coding and billing session for all of the physicians. We hired a coding specialist from one of the major health insurance companies to come to teach us how to best document and code for the services we were billing with the thought that the best person to teach us about correct documentation and coding was a person from an insurance company coding department. She told us that the staff in her department were told to deny every 10th claim. If the physician appealed the denial, then they would simply approve the claim and move on. But the insurance company had found that most physicians do not bother to appeal claim denials and just write them off. By randomly denying claims, the insurance company was able to save an enormous amount of money.

Medication denials are a particular problem. Many drugs are members of a class of medications that are all relatively interchangeable for most patients. For example, statins used for high cholesterol, ACE inhibitors used for high blood pressure, and inhalers used for asthma. The insurance company will negotiate with the drug manufacturers to get the lowest price for one of the drugs in a class of medications. These drugs are then placed on the insurance company’s “formulary” of approved medications; if a patient is prescribed a drug that is not on the approved formulary, then the patient has to pay retail price for that drug out of pocket. I deal with dozens of different insurance formularies. Some insurance companies permit a computer interface with physicians’ electronic medical record so that physicians can tell right away if a medication that they are prescribing is on that insurance company’s formulary and then pick another drug from that same class if it isn’t. But many insurance companies do not permit an interface with the physician EMR. Although the physician can go to the internet and look up a formulary, most of these on-line formularies are not very user friendly and often require the physician to scroll through pages and pages of a PDF file to hunt for a drug that would be covered – this can take the physician 5-10 minutes to determine which drug is or is not covered. If a non-formulary drug is prescribed, the physician will usually get a letter in the mail that the prescribed drug is not on the insurance company’s formulary. The problem is that those letters do not tell the physician what drug in the same class is covered so the physician either has to spend time on the internet trying to determine what is covered or continue to randomly prescribe medications in that drug category until they hit on one that is covered. Furthermore, the insurance companies change their drug formularies every January and a drug that is covered one year will often not be covered the next year resulting in a flurry of denial letters being sent to physician offices all over the country every January.

Prior authorizations and denials are a great business model for insurance companies, radiology benefit management companies, and pharmacy benefit management companies. By creating a barrier to approving expensive tests such as CT scans and MRIs, they can reduce the number of these expensive tests that are actually done. By denying medications that are not on their insurance formulary, they can reduce the number of prescriptions that are filled.

The sad part of prior authorizations and denials is that most of the time, the physician can eventually successfully appeal the denial of a test or a prescribed medication, as long as the physician is persistent and dedicates the time necessary for the appeal. The net result is that these denials and prior authorizations create an enormous cost to physician practices with no real benefit to the patient. As a consequence, the American prior insurance authorization and denial system is a major contributor to the U.S. having the most expensive healthcare in the world but still lagging other countries in quality of healthcare.

A 2018 report from Harvard concluded “Physician burnout is a public health crisis that urgently demands action by health care institutions, governing bodies, and regulatory authorities. If left unaddressed, the worsening crisis threatens to undermine the very provision of care, as well as eroding the mental health of physicians across the country.” Some of the primary drivers of burnout is burdensome administrative requirements, excessive bureaucratic requirements, and consequences of electronic medical records. Insurance denials and prior authorizations fit squarely into these drivers of burnout.

Ironically, the payers that generally pose the least denials and prior authorizations are Medicare and Medicaid. I am generally a strong proponent of free market economic systems but in this case, the American health insurance free market has resulted in a broken system that is increasing healthcare costs to Americans and contributing to physician burnout.

January 25, 2020

Categories
Outpatient Practice Physician Finances

Should Doctors Bill For Phone Calls?

Beginning in January 2019, the Centers for Medicare and Medicaid Services (CMS) rolled out G2012 – a new CPT code for “Brief communication technology-based service (virtual check-in)”. This code can be used for patient phone calls as well as electronic medical record patient portal contacts initiated by a patient. For the first time, doctors can charge for patient phone calls – but should they?

The details behind G2012 are that the physician cannot have seen the patient for a regular billable encounter for 7 days prior to the phone/portal encounter or for 24 hours after the phone/portal encounter. The medical discussion should be between 5 – 10 minutes and has to be between the patient and the doctor/NP/PA and not the office staff. The patient has to give verbal consent acknowledging that the telephone/portal visit will be billed. The patient must have been seen by the physician or a physician in the physician’s group within the past 3 years. This CPT code is compensated at 0.41 RVUs ($14.78 for Medicare).

When Medicare released its plans to roll out G2012 a year ago, physicians all over the country breathed a sigh of relief and said “…finally!”. Every physician who is responsible for direct patient care in the outpatient setting knows the burden of patient phone calls. On a typical Monday, I have 15-20 phone messages in my electronic medical record “in basket”. On a Monday after a holiday weekend, that number can increase to 25-30 and it is not uncommon for me to spend 1-2 hours on those Mondays just returning phone calls. It has been estimated that the average primary care practice gets 21 calls per day for every 1,000 patients in the practice.

There are additional CPT codes that are designated for phone calls of various lengths of time for physicians (99441, 99442, and 99443) as well as for advanced practice providers such as NPs or PAs (98966, 98967, and 98968). However, Medicare does not currently reimburse these codes so they are generally not used unless a commercial insurance company recognizes them. Similarly, there is a CPT code for email responses to patients for physicians (99444) and advanced practice providers (98969) but these are also not currently reimbursed by Medicare.

Some phone calls are entirely legitimate, for example, a person who gets an asthma flare when traveling out of town and needs advice and a new inhaler. But some phone calls are simply because a patient does not want to come into the office or a patient wants to avoid an office visit co-pay. In these situations, the physician is providing free healthcare to the patient. And that equates to uncompensated physician time as well as malpractice vulnerability. There are pros and cons to billing for phone calls.

Pros

  1. It can reduce overall healthcare costs. The office overhead expense associated with a face-to-face office visit can be considerable. As opposed to a regular office visit, there is no need for registration staff, nursing staff, office space use, and checkout staff with a phone call.
  2. It allows more flexible use of the physician’s time. The doctor can return that call at a time when he/she has a few free minutes rather than committing the doctor to a fixed appointment time for an office visit.
  3. It is more convenient for the patient. Having a medical problem managed by a phone call can obviate the cost of travel to the doctor’s office and the time involved in getting to and from the doctor’s office. For the patient who is a student or who is working, it also obviates the need to take time away from classes or time off work to go to the doctor’s office.
  4. It improves doctor satisfaction. Physicians have provided free medical care over the phone ever since phones came into existence. Knowing that you are getting paid something (even if not very much) can eliminate that sense of being taken advantage of that you otherwise would have. From my perspective, this is one of the most important reasons to bill for patient phone calls.
  5. It can create a barrier for patients who abuse the system. Every physician who practices outpatient medicine has had the last minute cancelation by a patient who then calls the office an hour later asking if the doctor can call them back and manage by phone the medical problem that they were supposed to come in for. The physician still has to pay the overhead cost of that no-show on the schedule in terms of the nurse’s salary, office rent, the receptionist’s salary, and the the utility bills not to mention the physician’s own salary. Every physician also has the patient who sends lengthy messages via the EMR patient portal on a daily basis or calls multiple times a week. The awareness that the patient (or at least their insurance) will be billed for those calls can reduce abuse.
  6. It encourages use of email communications through patient portals. Phone calls create more overhead expense than emails. There is the time the office staff takes to answer and transcribe patient messages, the time it takes someone to answer the phone when the physician calls back, the time it takes for the patient to actually get on the phone, the time it takes the physician to document the call in the medical record, etc. An email communication eliminates much of that overhead cost of office staff and physician time. Furthermore, when the patient has the doctor on the phone (as opposed to an email message), it often results in additional medical questions that follow the comment: “Oh, and while I have you on the phone…” and this adds additional time as well as complexity of medical decision making. I can answer 3 patient emails in the time it takes me to return 1 patient phone call.

Cons

  1. The patient has a co-pay. Although the reality is that at $2.50, it is a bargain. Nevertheless, for patients used to getting free medical advice over the phone, the co-pay can be surprising.
  2. The patient has to give verbal permission/acknowledgement that the phone call will be billed. The easiest way to do this is to incorporate scripting into the nurse or office staff who initially answers the phone and starts the phone message.
  3. Phone calls do not pay much. The cost of your revenue cycle department to submit and collect the phone call bill may be nearly the $14.78 you will be paid by Medicare for the phone call.
  4. It is not usually covered by commercial insurance. Usually, it takes commercial insurance companies a year or two to catch up to new CPT codes introduced by Medicare. Currently, few insurance companies cover phone calls so the patient may be charged the full amount. This can result in patient dissatisfaction (although it can be a deterrent to patients who abuse phone availability).
  5. The phone call must be for analysis or decision making that requires the physician. In other words, you should not be billing for a patient phone call that is simply to request to reschedule an upcoming office visit. It is the physician’s time that must be > 5 minutes and not the nurse’s time or the office staff’s time.
  6. The phone call must be at least 5 minutes. It only takes 1-2 minutes to send in a prescription refill and so it would be difficult to justify billing for a phone call simply to request a refill. However, for a patient with a COPD exacerbation, by the time the doctor reviews the patient’s past history in the chart, takes an interval history over the phone, checks for allergies, reviews the current medication list for potential drug interactions, sends a prescription for an antibiotic and prednisone to the pharmacy, and then documents the telephone encounter, it almost always takes at least 5 minutes. Be sure that the time spent on the encounter is documented in the medical record. Because Medicare auditors can audit time stamps in the electronic medical record, the amount of time between the physician initially opening the telephone encounter in the EMR until the time the physician closes that encounter must be > 5 minutes.
  7. It creates a disincentive for the patient to come into the office. Although it is true that you can practice a lot of medicine over the phone or over the internet, sometimes a physical examination is essential, even if just to get an accurate set of vital signs. Moreover, it becomes more difficult to arrange a needed EKG, a pulmonary function test, a chest x=ray, or blood tests when you are managing a patient over the phone as opposed to the patient being in the office where those tests are readily available in the office. If patients believes that they can get just as good of medical care with a phone call as they can by a face-to-face office visit, then they may stop coming into the office. Not only can this have the potential to jeopardize high quality care, but since the reimbursement for telephone calls is so low compared to an office visit, physicians who do nothing but phone calls all day long will soon go out of business.

When used appropriately, billing for phone calls is a win-win-win. The patient wins by getting their medical problem addressed without having to take the time involved in going to the doctor’s office or the emergency room. The insurance company wins because that $14.78 phone call can often avoid a much more expensive trip to the ER or an urgent care facility. The doctor wins because she/he now gets paid at least something with the psychological benefit to the doctor being worth considerably more than the financial benefit.

December 1, 2019

Categories
Emergency Department Inpatient Practice Outpatient Practice

Suicide Risk Assessment

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

Categories
Outpatient Practice

Making Wound Care Work

Hospital wound care clinics are one of those unheralded parts of healthcare. As our population ages, gets more obese, and has more diabetes, chronic wounds are only going to become more common and having a location within the hospital system that can provide a comprehensive approach to healing wounds is important today but will be even more important tomorrow.

A lot of wound care is general medicine

Many hospital leaders think of wound care as being a part of surgery. And it is true that surgical management is an important part of a comprehensive wound care program. However, healing wound really requires optimizing the patient’s medical conditions:

  1. Controlling diabetes
  2. Smoking cessation
  3. Nutrition optimization
  4. Improving blood flow
  5. Controlling infection

Therefore, physicians, nurse practitioners, and physician assistants who are trained in diabetes management, tobacco treatment counseling, nutrition, and treatment of infections are frequently in the best position to help optimize the patient’s ability to heal wounds. In other words, wound care is a perfect fit for general internists and family physicians.

Wound care does not mean “wound stare”

In order to really heal wounds, it is necessary to debride dead tissue. It is not enough to simply look at a wound every week without doing any intervention – the the patient’s regular primary care physician can already do that. A study in JAMA Dermatology showed that for 321,744 wounds at 525 wound centers in the United States, about 70% of wounds healed and required a median number of 2 debridements per wound. Wounds that were debrided more frequently healed faster and patients who were seen at least weekly in the wound centers had better outcomes.

Hyperbaric oxygen

Hyperbaric oxygen treatment uses a hyperbaric chamber where 100% oxygen is delivered under high pressure. These are body-sized tube-like chambers that the patient can lay in, typically for periods of 60 – 90 minutes at a time. Hyperbaric oxygen can promote wound healing by promoting angiogenesis and fibroblast proliferation. Patients return for repeated hyperbaric treatments as the wound heals. This requires a hyperbaric technician (often a respiratory therapist or EMT) to monitor the patient and manage the hyperbaric “dives”. Hyperbaric oxygen has been demonstrated to be effective in radiation injuries, osteoradionecrosis, osteomyelitis, threatened skin flaps, and diabetic ulcers. Generally 12-15% of would care patients benefit by hyperbaric oxygen treatments.

Wound care nurses

Wound care is more than just the doctors. Having wound care nurses who are trained and experienced in wound care is essential to a high-functioning wound care center. These are truly nurse specialists – it is not sufficient to use general outpatient nurses from medical or surgical clinics. Although a physician/NP may spend 10-15 minutes with each patient, the entirety of that patient’s visit is typically 45-60 minutes when vital signs, positioning, dressing removal, wound cleansing, patient education, and wound photography is factored in.

Sufficient space to practice in

Most primary care offices are set up with 2-3 exam rooms per physician. An effective wound center needs much more, typically 4-6 rooms per practitioner, since a lot of the actual care of the patient is actually done by the wound nurses rather than the physicians. Additionally, there needs to be a room large enough to co-locate 2-3 hyperbaric oxygen chambers so that a single hyperbaric technician can oversee multiple chambers at one time. The rooms need to be large enough to accommodate gurneys since many patients are non-ambulatory. Because wound care requires a lot of supplies, there has to be abundant storage space.

Staying financially viable

Wound centers should be able to at least break-even financially and most should be able to maintain a positive margin. However, to do so, there has to be more than just evaluation and management (E/M) billings. Wound care centers have a higher overhead than a typical primary care or medical specialty clinic given the higher nursing staffing and the higher equipment & supply costs. Therefore, a wound center that relies on E/M billing only will lose money. This is where hyperbaric oxygen treatments and debridements can help maintain sufficient income to offset the loses that would be incurred from E/M visits alone. Therefore financial viability requires a balance between E/M visits and hyperbaric/debridement services. Fortunately, since those hyperbaric treatments and the debridement procedures also improve patient outcomes, it is a win-win, for both the hospital and the patient. And, because hyperbaric treatments and debridements are also financially beneficial for the doctors, it is actually a win-win-win all the way around.

From the physician (or NP/PA) standpoint, there is strong incentive to participate in wound care in terms work RVU generation. The table below lists the common services and procedures performed in wound care (the dollar amounts are the Medicare reimbursable for 2019 in Ohio).

The most common procedure at most wound centers is simple debridement (99597) and skin & subcutaneous tissue debridement (11042). Tobacco cessation is an often-overlooked service in wound care since many patients with chronic wounds are smokers and it is easy to spend at least 3 minutes discussing smoking cessation strategies with the patient, often while doing a debridement.

Hyperbaric oxygen oversight is associated with a relatively large number of work RVUs (2.11) and is billed per treatment. This is different than the facility bill for hyperbaric oxygen which is billed for every 15 minutes of time that the patient is in the hyperbaric oxygen chamber. A patient who is in the chamber for 60 minutes is billed 4 units by the hospital (facility) and 1 unit of 99183 by the physician (or NP/PA). Since hyperbaric treatment oversight generally occurs at the same time that the physician is seeing patients in the wound center, this allows for a surprisingly large number of work RVUs to be generated in a single day of outpatient care.

So, how does wound care compare to regular outpatient practice for a family physician or internist? Assume that the primary care physician is in the office all day seeing level III return visits every 20 minutes. That equates to 23.28 work RVUs or 34.56 total RVUs ($1,217 in Medicare reimbursable dollars). If that physician is working in a wound clinic and doing 1 subcutaneous debridement for every 2 patients plus supervising 4 hyperbaric oxygen treatments, then this adds up to 43.84 work RVUs, 68.16 total RVUs, and $3,163 in Medicare reimbursement! In other words, wound care is one of the most lucrative things a family physician or general internist can do and can be a great way to supplement a traditional primary care practice.

Limb salvage

Inadequately treated foot and ankle wounds often result in osteomyelitis and leg amputations. A major goal of wound care is preventing amputations by “salvaging” the leg. Ideally, this requires a coordinated multidisciplinary approach including primary care physicians (or NPs/PAs), vascular surgeons, infectious disease specialists, and podiatrists. By making the wound center a “one-stop-shop” where the patient with a foot ulcer or wound can see multiple specialists, the care can be optimized and give that wound the best chance to heal without having to resort to amputation.

A natural fit for podiatrists

In most wound centers, diabetic foot ulcers are a major indication for services. This fits perfectly with podiatrists’ scope of practice. In Ohio, one limitation is that podiatrists cannot oversee or bill for hyperbaric oxygen treatments (although nurse practitioners can). An additional advantage that podiatrists have over other practitioners is that they are surgeons who spend a significant amount of their time in the operating room. In other words, the podiatrist has one foot in the ambulatory clinic and one foot in the OR (so to speak) which can facilitate comprehensive care of those foot wounds that require more debridement or surgical care than can be done in the wound center and which require surgical debridement in the operating room.

A multi-disciplinary approach

A high-functioning and effective wound center needs to have easy access to consultation by many types of physicians. Although the main providers responsible for the regular wound care visits may be general internists, family physicians, or nurse practitioners, there are a whole group of specialists whose availability is necessary for comprehensive care of the wound. These specialists may not necessarily practice in the wound center but there needs to be easy access to them, ideally in same facility, such as a hospital outpatient building. These include: plastic surgeons, podiatrists, orthopedic surgeons, vascular surgeons, infectious disease specialists, dermatologists, and endocrinologists. Other healthcare providers needed on-site include physical therapists, orthotists/prostesthetists, nutritionists, radiology services, and occupational therapists.

In summary, a comprehensive approach to wound care is an increasingly necessary part of the overall care provided by hospitals. To be effective, a wound center requires a considerable financial investment and then needs to maintain a coordinated multidisciplinary group of healthcare providers to optimize wound healing rates. Fortunately, under current Medicare reimbursement rates, wound care is financially attractive to physicians, particularly general internists and family physicians.

October 12, 2019

Categories
Outpatient Practice

Telomeres And Pulmonary Fibrosis

My stepfather was the quintessential short telomere syndrome patient. His hair turned gray in high school, his father died of idiopathic pulmonary fibrosis, his sister died of idiopathic pulmonary fibrosis, and then he too died of idiopathic pulmonary fibrosis, complicated by bone marrow failure from myelodysplasia. Last month, I attended an international conference on telomeres in lung transplant and the information from that conference has profound implications for treating our patients with these conditions.

Telomeres are repeating sequences of the DNA nucleotides, TTAGGG, that are on the ends of our chromosomes and serve to protect the genes inside those chromosomes from damage, kind of like how the plastic caps on your shoelace protect the shoelace from unraveling and becoming damaged.

We are all born with fairly long telomere segments at the end of our chromosomes but then as we age, our telomeres shorten, presumably making the genes underneath these chromosomes more more fragile and subject to damage. Thus, our telomeres start off about 11 kilobases when we are born but by age 80, they have shortened by two-thirds, to 4 kilobases.

The reason that we lose these repeating TTAGGG sequences is that when our chromosomes divide, about 50-100 base pairs of telomere DNA is lost from the end of one of the two chromosomes because of the way that a chromosome divides and then re-builds new twin strands of DNA to form the 2 new chromosomes.

Our cells can restore these lost telomeres by using a protein complex called “telomerase” that adds TTAGGG nucleotide groups to the ends of our chromosomes. But if there is a genetic abnormality in one of this group of proteins, then telomerase does not work properly and cannot fully restore the telomeres to their previous length. Thus, with each chromosomal division of mitosis, the telomeres get a little shorter. Telomeres are akin to a “molecular clock” in our cells and some people have postulated that if we can maintain normal telomere lengths, that we may be able to avoid the scourge of aging, in other words, create a Fountain of Youth. Although it is not clear if this is possible, it does appear prematurely shortened telomeres due to an abnormal telomerase protein gene results in the opposite, in other words, a “Fountain of Age”.

A patient with one of these abnormal genes will have telomeres that are shorter than normal people of their same age. This results in “short telomere syndromes”. In adults, the main short telomere syndromes are:

  1. Familial idiopathic pulmonary fibrosis
  2. Cirrhosis
  3. Aplastic anemia
  4. Myelodysplasia
  5. Prematurely gray hair

There are two ways to measure telomere length: a polymerase chain reaction (PCR) method and a fluorescent in situ hybridization (flow-FISH) method. The flow-FISH method is considerably more accurate than the PCR method. People can get a take-home telomere PCR test done essentially over-the-counter for about $100 through internet DNA companies. The flow-FISH method is only available at a few university laboratories, requires a physician order, and costs $400-800. I send my patients’ blood to be tested at one of these labs that use the flow-FISH method. The length of telomeres that indicates a short telomere syndrome is unknown but when the length is less than the lowest 1st percentile, I consider it highly likely. Since my clinical practice is primarily patients with interstitial lung diseases (including idiopathic pulmonary fibrosis), I end up seeing a number of these patients. Here is a telomere length test result on one of my patients with familial idiopathic pulmonary fibrosis, cirrhosis, and pancytopenia from a hypocellular bone marrow:

Idiopathic pulmonary fibrosis patients with short telomeres are different

There are some important differences in patients with familial idiopathic pulmonary fibrosis and short telomeres compared to everyone else with idiopathic pulmonary fibrosis. First, they do poorly with immunosuppressives. In the past, we used to use medications that suppressed the immune system to treat idiopathic pulmonary fibrosis, thinking (incorrectly) that inflammation was the genesis of the lung scarring that characterizes the disease. A number of years ago, there was a study sponsored by the National Institutes of Health comparing a treatment with the immunosuppressive medications azathioprine and prednisone with placebo. It turned out that the patients who got azathioprine or prednisone did a lot worse than those getting placebo. Recently, researchers went back and looked at stored blood samples of the patients who were in this study and it turns out that only those patients with short telomeres did poorly with immunosuppressive medications – patients with normal telomeres had the same outcome whether they received immunosuppressive medications or placebo.

Second, these patients do poorly after lung transplant. They are more prone to developing low white blood cell counts, presumably from being more susceptible to side effects of immunosuppressive medications. Also, they are more prone to getting devastating infections with cytomegalovirus (CMV) and aspergillus. Patients with short telomeres who get lung transplants can develop myelodysplasia or cirrhosis after lung transplant and those with liver transplants can develop myelodysplasia or pulmonary fibrosis after liver transplant.

More Questions Than Answers

Our understanding of short telomere syndromes and how to best medically manage these patients is still in its infancy. There is much that we do not yet know. For example:

  1. Which patients with idiopathic pulmonary fibrosis should undergo telomere length testing? Currently, I limit testing to those patients with a family history of idiopathic pulmonary fibrosis who also have a personal or family history of premature graying of the hair, unexplained cirrhosis, myelodysplasia, or unexplained cytopenia. Telomere length testing is not widely available and not always covered by insurance. If it only cost $25 and insurance covered it, I would probably order it on all of my patients with idiopathic pulmonary fibrosis. In addition, there may be other lung diseases associated with short telomeres. For example, pleuropulmonary fibroelastosis appears to be associated with short telomeres.
  2. Which patients with cirrhosis should undergo telomere length testing? NASH (non-alcoholic steato-hepatitis, aka fatty liver) is the most rapidly growing cause of cirrhosis due to the epidemic of obesity and diabetes in the United States. It seems like whenever there is no obvious cause of cirrhosis (such as hepatitis C or alpha-1-antitrypsin deficiency), then patients get labeled as having NASH cirrhosis by default. Many patients who carry a diagnosis of NASH cirrhosis likely have liver disease due to short telomeres.
  3. Should every patient with short telomeres be referred for genetic testing? Genetic testing is usually done in conjunction with genetic counseling by trained genetic counselors. Unfortunately, these counselors are in short supply and are mainly associated with pediatric hospitals and cancer hospitals. Furthermore, genetic testing is not cheap and typically costs around $800; most insurance companies will not cover it or will only cover it after a lot of physician effort doing denial appeals. The results of genetic testing in short telomere syndromes can be difficult to interpret – these syndromes can be associated with abnormal genes such as TERT and TERC but these genetic abnormalities can also be seen in some otherwise normal people.
  4. Should telomere length testing be done in all patients prior to transplant? One of the basic tenets of transplantation is to offer it to those patients who will most benefit by transplant. Since some studies indicate that patients with short telomeres have worse outcomes after transplant, should this affect their transplant eligibility? Could short telomeres be a relative contraindication to transplant?
  5. Should transplant patients with short telomeres get different immunosuppression regimens? Since it appears that patients with short telomeres do poorly with immunosuppressive medications, it may be that they need to have reduced doses of these medications when used to prevent transplant rejection. Or perhaps there are some immunosuppression regimens that are safer than others in patients with short telomeres. Once again, at this time, we just do not know.
  6. Should patients with short telomeres get combined lung and liver transplants? These patients are prone to getting both pulmonary fibrosis and cirrhosis and not infrequently does cirrhosis become apparent only after lung transplant for pulmonary fibrosis and vice versa. At the least, patients with known short telomeres undergoing liver transplant should probably be screened for interstitial lung disease and those undergoing lung transplant should be screened for cirrhosis. Most combined lung/liver transplants in the United States are done in patients with cystic fibrosis. Many centers have found that combined lung/liver transplant in other patients has a high mortality rate. One has to wonder whether a lot of these non-cystic fibrosis patients who have had combined lung/liver transplant actually had undiagnosed short telomere syndromes.
  7. Should patients with short telomeres undergoing transplant get a bone marrow biopsy? This is not part of the normal work-up for patients undergoing either lung or liver transplant. But the development of myelodysplasia or it malignant cousin, acute myelogenous leukemia, can be devastating in the post-transplant period. Clues to subclinical myelodysplasia can include unexplained macrocytosis (increased MCHC), leukopenia, or thrombocytopenia. No transplant physician likes a hematologic surprise after transplant.

One of the simultaneously frustrating and exciting things about medicine is that just when we think that we know everything, we realize that we don’t. Short telomere syndromes epitomize this axiom – clearly, we have much more to learn.

October 2, 2019

Categories
Inpatient Practice Outpatient Practice

Influenza Always Gets The Last Word

I am on this earth because of influenza. This is the 100th year anniversary of the influenza epidemic of 1918 that infected 1/3 of the word’s population and killed 1 out of every 10 people infected. One of those people was my grandmother’s first husband. She was a nurse at a hospital in Durham, North Carolina and after her husband’s death, she met a physician fresh out of medical school, my grandfather. So, if the influenza epidemic had not have occurred, she and my grandfather would never have married and I never would have been born.

All told in 1918, 675,000 Americans died of influenza; that works out to 1 out of every 150 citizens. It was particularly lethal for young persons with the result that the U.S. life expectancy dropped from 49 years to 37 years for men and from 54 years to 42 years for women. The influenza strain that swept the world in 1918 was H1N1, the same strain that caused the 2009 pandemic of influenza that also seemed to preferentially kill young adults.

In 2009, 12,000 people in the United States and a half million people worldwide died of influenza. The problem in 2009 was that the strain of H1N1 that emerged was one that had not circulated in humans for decades – about 1/3 of people over age 65 years had antibodies to it from past infection but few young adults had ever been exposed to H1N1 and thus few young people had any immunity at all. Most years, 80% of influenza deaths are in people over age 65 but in 2009, 80% of deaths were in people under age 65. The H1N1 pandemic was therefore notable not for the total number of deaths (which was actually rather low) but for the fact that most of the deaths occurred in young adults. Even in non-pandemic years, influenza kills thousands of Americans. For example, last year, the CDC estimates that 80,000 Americans died of influenza and its complications, the most deaths in 4 decades.

As of December 22, 2018, the epidemiology of this influenza season (red line in this graph from the CDC) is falling in-between that of the 2016-2017 season and the 2017-2018 season. Most of the influenza being seen this year is once again the influenza A H1N1 strain with a smattering of H3N2 and influenza B. The flu claimed its first celebrity of the season this week when 26-year-old Fox News commentator, Bre Payton, died the day after developing influenza.

Yet still there are people who fear influenza vaccinations and refuse to get a simple and inexpensive flu shot that can save their lives. Here are some of the reasons for not getting a flu shot that I hear from my own patients:

  1. “I always get the flu every time I get a flu shot.” It is impossible to get the flu from a flu shot as there is no live virus in the vaccine. You are no more likely to get the flu from a flu shot as you are to get pregnant from taking a birth control pill. Yet nevertheless, more than half of parents believe that their child can contract the flu from a vaccine.
  2. “I don’t need a flu shot because I never get the flu.” This is like saying that you don’t need to wear a seatbelt because you’ve never been in a car accident. These people probably have had the flu but just didn’t realize it and attributed their symptoms to a cold or other illness. No human in innately immune from influenza. If you inhale a bunch of influenza viruses, then you are going to get the flu.
  3. “I don’t want a flu shot because it causes autism.” Yes, and the earth is flat, unicorns are real, and the tooth fairy plays poker with Elvis and the Easter bunny every Saturday night. Conspiracy theorists love this one. 20 years ago, in 1998, Andrew Wakefield published a paper in the journal, The Lancet, suggesting that the measles, mumps, and rubella vaccine was linked to childhood developmental disturbances. It turned out that Wakefield was funded by attorneys who were suing the vaccine manufacturer for allegedly causing autism. Wakefield was later found guilty of fraud, he lost his license to practice medicine, and the journal retracted his article. But the myth lived on and in 2005, journalist David Kirby published the book Evidence of Harm – Mercury in Vaccines and the Autism Epidemic: A Medical Controversy that alleged that thimerosal in vaccines causes autism. That same year, class action attorney Robert F. Kennedy, Jr. wrote an article in the Huffington Post making the same allegation (presumably setting himself up to win the mother of all class action lawsuits). Celebrities bought into this, most notably actor Charlie Sheen and former Playboy playmate, Jenny McCarthy, who have become the voices of anti-vaccine activism. Most influenza vaccines do not contain any thimerosal (the preservative that contains mercury). Even those that do contain thimerosal have the same amount of mercury as is in about 4 oz of canned tuna HOWEVER, thimerosal is broken down in our bodies as ethylmercury whereas fish contains methylmercury – ethylmercury is relatively harmless compared to methylmercury. The science is very strong: vaccines do not cause autism.
  4. “I don’t need a flu shot because last year I got one and still got the flu.” Yes, it is true that influenza vaccines are not 100% effective in preventing the flu. However, by creating protective antibodies against influenza, your body will be able to fight it off better so that even if you get the flu, it will be a milder case and you will be less likely to die. A study this year by the CDC found that patients who were admitted to the hospital with influenza and had gotten a flu shot spent four fewer days in the hospital, were 37% less likely to be admitted to the ICU, and were 2-5 times less likely to die compared to those patients who had not received a flu shot.
  5. “If I go outside in the cold and wet air, I’ll get the flu whether or not I get a flu shot.” Influenza is not an environmental microorganism, it lives in people and is transmitted by people. You cannot get the flu (or a common cold) by going outside when the temperature is low or when it is raining. In fact, if you spent all of your time outdoors in flu season, you’d be less likely to get influenza than if you are inside a building in close contact with other people who have the flu.
  6. “I always wait until December to get my flu shot so that it will kick in when the flu seasons hits.” Although it is true that antibody levels will peak several weeks after getting an influenza vaccine, a person cannot predict when they are going to be exposed to the virus in any given year. Getting a flu shot on Monday will not do much good if you are exposed to influenza on Wednesday. A person is better off getting the vaccine as early as possible in the flu season, ideally before the end of October. That being said, it is not too late to get vaccinated, even in January or February, as influenza usually continues to circulate in the United States until March or April each year.
  7. “I don’t want to get a flu shot because I might be pregnant.” If I only had one dose of the flu vaccine in my office, I would save it for a pregnant woman. There is no risk to vaccinating pregnant women and in fact, in the H1N1 pandemic of 2009, pregnant women were among those who were most likely to die when infected with the virus.
  8. “I don’t want a flu shot because I might get Guillian-Barré syndrome.” Every year, 3,000 – 6,000 Americans get Guillian-Barré syndrome (GBS) but every year, 10,000,000 – 50,000,000 Americans get influenza. The vast majority of GBS is not related at all to influenza. However, in 1976, the swine flu vaccine did have an increase risk of GBS with the result that one out of every 10,000 people vaccinated developed GBS. Since that time, the increase in GBS has been about 1 case for every 1 million influenza vaccines. The mortality rate of GBS is 2.8% and the mortality rate of influenza is about 0.16%. If you do the math, there are about 150 influenza vaccine-related cases of GBS in the U.S. each year with about 4 of these patients dying. Therefore, you are about 10,000 times more likely to die of influenza if you are not vaccinated than you are to die of GBS if you are vaccinated. As a general rule, I am not a gambler but I’l take the 10,000:1 odds any day.
  9. “I can’t take the flu shot because I’m allergic to eggs.” Because many influenza vaccines are grown in eggs, these vaccines can contain a tiny amount of egg protein. Nevertheless, the CDC recommends that people with egg allergies should still get influenza vaccinations. Patients with anaphylaxis from eggs should be observed in a medical setting after getting a flu shot. However, studies of over 500 patients with anaphylaxis from eggs and who received influenza vaccines found that none of these people developed a serious reaction from the vaccine. People who can eat cooked eggs are very unlikely to have any reaction to influenza vaccines. For those people who are still afraid of the influenza vaccine because of fears of egg allergy, there is a recombinant influenza vaccine (Flublok) that does not contain any egg protein.
  10. “Flu shots are too expensive.” Most insurance plans cover influenza vaccination and if a person without insurance goes to the local pharmacy, that person will pay about $40 to get it out of pocket. On the other hand, we spend about $10 billion per year in the United States on direct costs of flu-related illness and have another $16 billion per year in lost earnings from flu-related illness. That works out to each case of influenza costing about $530. So, instead of looking at the flu shot as costing you $40 each year, look at it as saving you $490 each year.

At the time of writing this blog post, influenza is already widespread in many states. In the next few weeks, my hospital’s nursing units and ICU will be full of patients with influenza-related illness, and some of them will die. Those patients who survive the ICU are always the first ones to ask for a flu shot the next year. But for those who die, like Bre Payton, influenza always gets the last word.

December 29, 2018