Categories
Outpatient Practice

Prostate Cancer Screening

The prostate cancer screening pendulum just swung… again. One of the most vexing problems in outpatient medicine has been prostate cancer screening: who should be screened and when should they be screened? New developments are finally giving us some clarity. We have a highly effective screening test in the prostate specific antigen test (PSA). This simple blood test is inexpensive and widely available. Finding an elevated PSA can result in detecting prostate cancer at an early, curable stage. But sometimes, the PSA can be too good.

Every year, our hospital holds an annual Community Day where physicians and hospital staff volunteer their time to provide free health information and screening tests to the public. Many of the community members attending are uninsured and low income so Community Day is their only source of screening for chronic diseases and cancers. A few years ago, the hospital agreed to perform free PSA tests and I asked two doctors to staff a prostate cancer screening station. One doctor said “If attendees don’t get PSA tests, I’m not going to participate” and the other doctor said “If attendees do get PSA tests, I’m not going to participate“. So which doctor was right? This is a question that as a 64-year-old man I’ve thought about a lot and it turns out that that both of them were right and both of them were wrong.

The history of PSA screening

Prostate cancer is the most second most common cancer in men (after skin cancer) and the second most common cause of cancer death in men (after lung cancer). It is estimated that 288,300 American men will be diagnosed with prostate cancer and 34,700 American men will die from prostate cancer in 2023. Prostate cancer is most commonly first identified by an elevated PSA level.

The PSA test was first approved in 1986 and became widely used to screen for prostate cancer in the 1990’s. With widespread screening came a dramatic increase in the number of new prostate cancer diagnoses that peaked in 1992 at 225 per 100,000 population, as shown by the light green squares in the graph below.

But despite all of these new cancers being found, there initially was no significant reduction in the prostate cancer death rate, as shown by the dark green triangles in the graph above. The implication was that the PSA test was finding lots of very low-grade, slow-growing cancers that were never going to spread during a man’s life. This raised a concern that we were doing a lot of unnecessary prostatectomies on men who did not need them… and prostatectomies have a significant risk of causing urinary incontinence and impotence. In addition, at the time, an elevated PSA was followed by a transrectal prostate biopsy that carried with it a 2-4% incidence of sepsis and further concern was raised that we were subjecting a lot of men to unnecessary biopsies. The enthusiasm for universal PSA testing began to wane and then in 2009, the PLCO study was published in the New England Journal of Medicine that caused many physicians to stop screening for prostate cancer altogether.

The PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) examined 76,693 men American men who were randomized to either get annual PSA tests for 6 years or get “usual care”. After 7 to 10 years, there was no difference in prostate cancer mortality between the two groups and it was concluded that annual PSA testing does not lower the death rate from prostate cancer. As a result, in 2012, the United States Preventive Services Task Force (USPSTF) gave the PSA a grade “D” recommendation, meaning that the harm of testing outweighed the benefits of testing. Overnight, prostate cancer screening braked to a halt. A second study in 2009 from Europe looked at 182,000 men randomized to either be screened every 4 years with a PSA or to not be screened. This study did find a 20% reduction in prostate cancer deaths in the group undergoing screening but the USPSTF chose to base its decision on the U.S. study rather than the European study.

But then in 2016, it came to light that in the PLCO, 90% of the men randomly assigned to the “usual care” group actually had a PSA test before or during the PLCO study by their regular physicians. In other words, both groups of men were getting screened using the PSA. It is not surprising, therefore, that there was no difference in the prostate cancer survival between the two groups in the PLCO study. This new revelation was published as a letter to the editor in the New England Journal of Medicine in 2016 and thus did not get as widespread attention as the original PLCO study 7 years earlier. Another important feature of the PLCO study was that only 4% of subjects were African American (who have a higher risk of prostate cancer) whereas in the U.S. as a whole, 12% of men are African American. In 2018, the USPSTF published new prostate cancer screening guidelines upgrading the PSA test to a grade “C” recommendation that stated “The decision to be screened for prostate cancer should be an individual one.” In other words, the USPSTF left it up to each doctor to decide whether or not to screen any given man for prostate cancer using a “shared decision making” approach.

In the past five years, there have been 4 new studies of PSA screening that have all shown that screening reduces prostate cancer death, ranging from 1 death prevented for every 101 men screened to 1 death prevented for every 570 men screened. Taken together, the data to support PSA screening is looking better and better every year.

New developments

Since the peak use of the PSA to screen for prostate cancer in 1992, there have been a number of developments that have changed our approach to the diagnosis and treatment of prostate cancer:

  • The open radical prostatectomy has been largely replaced by the minimally invasive robotic prostatectomy which has lowered the complication rate of surgery.
  • Advances in radiation therapy have led to radiation therapy now being a non-surgical treatment option for many men with prostate cancer.
  • There is greater recognition that certain men are at significantly higher risk of getting prostate cancer and of dying from prostate cancer. These include African Americans, those with a family history of prostate cancer, those with the BRCA gene and those with another genetic condition called Lynch syndrome. In addition, men who develop prostate cancer at a young age are more likely to have aggressive, fatal prostate cancer than those who develop it during older ages.
  • The prostate MRI has emerged as the preferred initial test for men with an elevated PSA and this has reduced the need for subsequent biopsy by 28%.
  • The transrectal prostate biopsy that carried with it a 2 – 4% risk of sepsis has been largely replaced by the less risky transperineal prostate biopsy which has a < 1% risk of sepsis.
  • There are new androgen-deprivation treatments and chemotherapies for patients with metastatic prostate cancer that can significantly prolong survival.

The net result of all of these developments in addition to the use of PSA testing has been a reduction in the mortality rate of prostate cancer from 39.2 per 100,000 men in 1992 to 18.6 per 100,000 men in 2020. That is a 50% reduction in mortality!

So who should we screen in 2023?

It remains true that many men with prostate cancer have slow-growing cancers that will never require any treatment. In these men, if you find a prostate cancer, you probably are not going to treat it and knowledge of the cancer only causes the man anxiety. Screening these men violates the cardinal rule of “Don’t ask a question that you don’t want to know the answer to“. Our challenge is to preferentially screen only those men who are at higher risk of developing a prostate cancer that will actually kill them. The current USPSTF recommendations of “shared decision making” between the primary care provider and the patient is vague and nebulous. It can leave the physician with the sense that the USPSFT is just saying “We really don’t know what to recommend, so you decide“. In order to provide a bit more direction, here are my personal recommendations:

  • PSA testing starting at age 40: African American men, men with a family history of prostate cancer, men with BRCA1 or BRCA2 gene and men with Lynch syndrome.
  • PSA testing starting at age 50: all other men.
  • Don’t do a rectal exam as part of screening (reserve it only for those men with an elevated PSA).
  • Repeat the screening PSA every 1-2 years.
  • Stop PSA testing in most men at age 70 or in men with less than 10 years to live. For exceptionally healthy men, continued screening into their 70’s is prudent.

There are a few other caveats to PSA screening. Do not do a PSA test in a man with a urinary tract infection (false positives). If the PSA is elevated, the next step is usually to just repeat the PSA in 4 – 6 weeks (there are other reasons for false positives). What constitutes an elevated PSA depends on the man’s age: PSA > 2 in their 40’s, PSA > 3 in their 50’s & 60’s, PSA > 4 in their 70’s. Not every elevated PSA is from prostate cancer – chronic prostate inflammation, prostatic hypertrophy, and prostate trauma can also cause a high PSA level.

For a more in-depth update on PSA testing, you can watch a recent OSU MedNet webcast on prostate cancer screening by the Ohio State University’s Dr. Shawn Dason by clicking here.

Getting back to the hospital’s Community Day

Should you offer PSA testing as part of a cancer screening program at a hospital community day or health fair? I think that the answer is “Yes!”. However it should be targeted to men between the ages of 50 – 70 years old. For those men with risk factors (African American, family history, genetic predisposition), an age range of 40 – 70 is preferred. Screening should be accompanied by a discussion with the patient that not every man with an elevated PSA will have prostate cancer and not every prostate cancer has to be treated. That discussion should also include that prostate MRI and transperineal biopsy can now be done instead of the older transrectal biopsy, resulting in fewer complications.

The PSA pendulum has swung from screen all men to screen no men and most recently to screen some men. I believe that the pendulum is now swinging towards screening all men at an appropriate age. Primary care providers should get ahead of the pendulum and implement these screening practices now.

June 23, 2023

Categories
Outpatient Practice

Designing A Long-COVID Clinic

Long-COVID is also known as PASC (post-acute sequela of COVID). A study in this week’s JAMA found that 10% of people infected with COVID had symptoms lasting for more than 6 months. These symptoms negatively affect quality of life and can result in significant impairment. There is a need for hospitals to create specialty clinics for PASC patients.

Long-COVID symptoms

Development of long-COVID symptoms depends on several variables. For example, women are twice as likely to develop long-COVID symptoms after an infection than men. People with repeated COVID infections are more likely to develop long-COVID symptoms than those with a single infection. People infected with the Delta variant are more likely to develop long-COVID symptoms than those infected with the Omicron variant. The severity of the initial infection also affects the likelihood of developing long-COVID: infected persons requiring hospitalization or ICU care are twice as likely to develop long-COVID symptoms compared to those with milder infections treated as outpatients. Other risk factors for developing long-COVID symptoms are being unvaccinated, older age, smoking, pre-existing chronic medical conditions, and obesity.

Long-COVID is a heterogeneous condition and patients can have a wide variety of symptoms. Most of these symptoms are non-specific. Among those who develop long-COVID symptoms, the most common include:

  • Post-exertional malaise (87%)
  • Fatigue (85%)
  • Brain fog (64%)
  • Dizziness (62%)
  • GI symptoms (59%)
  • Palpitations (57%)
  • Hearing difficulties (54%)
  • Joint pain (42%)
  • Weakness (42%)
  • Sexual impairment (42%)
  • Smell/taste impairment (41%)
  • Headache/muscle pain (39%)
  • Shortness of breath (36%)
  • Cough (33%)

Long-COVID clinic structure

Because of the wide variety of symptoms that people with long-COVID can develop, the evaluation of patients should be tailored to the specific presenting symptoms. The key purposes of a long-COVID clinic should be (1) to measure quantifiable impairment, (2) exclude other conditions that mimic long-COVID, (3) prescribe treatments to relieve symptoms, and (4) direct rehabilitation efforts. The long-COVID clinic should in a location that has on-site EKG testing, phlebotomy for lab testing, and radiology for chest x-rays. It should also be in close proximity for schedulable tests such as pulmonary function tests and echocardiograms.

A full set of vital signs (including resting pulse oximetry) should be performed for each visit. The clinic should be able to refer patients for speciality consultation including cardiology, pulmonary, rheumatology, physical medicine, sleep medicine, physical therapy, occupational therapy, and dietary. Ideally, there should also be access to a pulmonary rehabilitation and cardiac rehabilitation program in the area. Because of their protocol-driven nature, long-COVID clinics are an opportunity for advance practice providers (nurse practitioners and physician assistants).

For most patients, symptoms of acute COVID infection can take many days or even several weeks to fully resolve. The majority of these patients do not require evaluation in a specialized long-COVID clinic. It is reasonable to set a threshold of symptoms persisting for more than 6 – 12 weeks as criteria for referral to a long-COVID clinic. The initial evaluation should include a complete history and physical examination with attention to symptoms during the acute phase of the COVID infection, severity of the infection, vaccination status, age, BMI, smoking status, and co-morbid medical conditions.

Special effort should be given to medication reconciliation at the initial visit. Patients who were hospitalized for acute COVID infection are particularly likely to have had previous medications discontinued during hospitalization and/or new medications started. Sometimes these changes were because a chronic medication was not needed during hospitalization. Sometimes a chronic medication was stopped or changed during hospitalization due to a prohibitory drug-drug interaction with a medication necessary to treat the COVID infection. Or sometimes a drug was changed during hospitalization because that drug was not on the inpatient hospital formulary. During medication reconciliation, attention should be directed toward eliminating duplicate medications, discontinuing unnecessary medications, and resuming maintenance medications held during the acute infection.

Symptom-directed diagnostic testing

The history and physical exam may dictate initial testing. For example, the finding of dry crackles on pulmonary auscultation may dictate pulmonary function tests and a high resolution chest CT. On the other hand, pedal edema, an S3, and moist crackles may dictate a BNP test and an echocardiogram. Sudden onset of dyspnea and pleuritic chest pain shortly after resolution of an acute COVID infection may dictate a d-Dimer test and/or a CT pulmonary angiogram. Diagnostic testing in other patients should be ordered based on the specific long-COVID symptoms each patient has:

Fatigue: Laboratory testing should include: CBC, TSH, chemistry panel, and LFTs. An EKG should be performed. Oxygen saturation at rest and during exercise should be measured (for example, using the 6-minute walk test). Because many of the risk factors of long-COVID are also risk factors for obstructive sleep apnea, patients with fatigue should be screened for sleep apnea (for example, using the STOP-BANG questionnaire). Patients who received corticosteroids as part of their acute COVID treatment should be tested for adrenal insufficiency.

      • Mimics include: anemia, chronic kidney disease. chronic liver disease, sleep apnea, adrenal insufficiency, and hypothyroidism

Shortness of breath: Initial testing should include: BNP, CBC, TSH, chemistry panel, LFTs, chest x-ray, 6-minute walk test and EKG. If these tests are unremarkable, then additional testing could include a full set of pulmonary function tests (spirometry, flow-volume loop, lung volumes, diffusing capacity) and an echocardiogram. If these tests are also unremarkable, then a cardiopulmonary exercise test (CPET) should be considered. If post-inflammatory pulmonary fibrosis is suspected based on chest x-ray abnormalities (or crackles on pulmonary auscultation), a high resolution chest CT should be obtained. Patients with resting or exertion hypoxemia in the absence of radiographic abnormalities should be screened for thromboembolic disease with a d-Dimer test or CT pulmonary angiogram.

      • Mimics include anemia, heart failure, hypothyroidism, chronic kidney disease, chronic lung disease (asthma, COPD, interstitial lung disease), pulmonary embolism, and vocal cord dysfunction

Cough: Initial testing should include a chest x-ray and spirometry with flow-volume loop.

      • Mimics include asthma, gastroesophageal reflux, post-nasal drip, use of ACE inhibitor medications, and vocal cord dysfunction

Brain fog: Initial testing should include CBC, chemistry panel, LFTs, TSH, and 6-minute walk test. A screening test for cognitive impairment should be performed; in the past, this was typically the Mini-Mental State Examination (MMSE) but because that test now requires a fee to perform, the free SAGE test may be preferred. Another screening test for cognitive dysfunction is the Montreal Cognitive Assessment (MoCA); however completion of a mandatory 1-hour training program is required to perform this test.

      • Mimics include anemia, hypothyroidism, chronic liver disease, hypoxemia, sleep apnea, and early dementia

Dizziness or palpitations: Initial testing should include CBC, BNP, EKG, orthostatic blood pressure measurement, and 6-minute walk test. If these tests are unremarkable, additional testing could include Holter monitor, echocardiogram, and tilt-test.

      • Mimic include anemia, heart failure, orthostatic hypotension, and cardiac arrhythmias

GI symptoms: Initial testing should include CBC and LFTs. Patients with diarrhea should be tested for C. difficile if they received antibiotics or were hospitalized. Older age is a risk factor for both long-COVID and lactose intolerance.

      • Mimics include C. diff gastroenteritis, lactose intolerance, and irritable bowel syndrome

Weakness or muscle pain: Initial testing should include chemistry panel, CK, TSH, and LFTs.

      • Mimics include electrolyte disorders, drug side effects (statins), and hypothyroidism

Taste and olfactory dysfunction: These are common after COVID infection, particularly with the earlier Delta variants. There is no particular testing required but nutritional assessment may be useful in those losing weight due to altered diet resulting from abnormal taste and smell. Patients with smell dysfunction should be advised to have working smoke detectors in their homes.

      • Mimics include chronic sinusitis

Chest x-ray abnormalities: Patients with pulmonary infiltrates at the time of the initial COVID infection should have a follow-up x-ray. If infiltrates persist beyond 12 weeks, a chest CT should be performed. It should be noted that 50% of patients hospitalized with COVID who have x-ray abnormalities at the time of initial infection will still have x-ray abnormalities 6 months after the infection. However, because older age and cigarette smoking are risk factors for both long-COVID and lung cancer, resolution of chest x-ray abnormalities must be confirmed.

      • Mimics include lung cancer

Rehabilitation

Patients with severe impairment, particularly those with neuromuscular impairment, may require referral to a physical medicine specialist to direct rehabilitation. Patients with fatigue, mild-moderate exercise limitation, cardiac symptoms, and pulmonary symptoms can usually have rehabilitation efforts overseen from a long-COVID clinic. Prior to recommending a rehabilitation regimen, patients should complete diagnostic testing to exclude other medical conditions mimicking long-COVID and to identify any objective evidence of cardiorespiratory impairment.

Deconditioning is common following COVID infection. Patients are often sedentary for many days and often sustain weight loss and nutritional deficits during the acute COVID infection. In these patients, dietary guidance to restore body mass coupled with a regular exercise program can be very effective. There is not a single “best” exercise for patients with long-COVID symptoms, rather the best exercise is whatever exercise the patient will actually do consistently. In general, patients should be given a target of 150 minutes of weekly aerobic exercise (walking, stationary bike, treadmill, swimming, etc.). Patients with moderate or severe deconditioning may require several weeks to work up to 150 minutes per week. One of the barriers to aerobic exercise is the fear that exercise-induced dyspnea is a warning sign that the body is being harmed from exercise. A pulse oximeter can be very helpful to reassure patients that their oxygen level remains normal despite dyspnea and to help guide the heart rate during exercise. Patients should target keeping their heart rate during exercise at < 60% of their maximum predicted heart rate (maximum predicted heart rate = 220 – age).

Formal cardiac rehabilitation and pulmonary rehabilitation programs can be beneficial but Medicare will only cover these programs if there is objective evidence of cardiac or pulmonary impairment (some commercial insurance companies have less strict criteria for admission into these programs). For patients not eligible for cardiac or pulmonary rehabilitation, referral to a physical therapist can be useful, not only to define physical capabilities but for exercise guidance.

The special case of athletes

Vaccine skeptics often point to vaccine-induced myocarditis as a reason to avoid vaccination. However, a 2022 study found that people are 11-times more likely to get myocarditis from a COVID infection than they are from a COVID vaccination. Moreover, previous vaccination cut the chances of getting myocarditis after a COVID infection by half. Fortunately, most people who develop myocarditis (from either infection or vaccination) go on to have complete recovery. Nevertheless, those who have myocarditis at the time of their initial COVID infection should undergo cardiology consultation prior to resuming athletic activities.

Long-COVID can be devastating for a young athlete. Missing one season of their sport can mean an end to their high school or college athletic career. It is especially important to evaluate young athletes with long-COVID symptoms for exercise-induced bronchospasm and vocal cord dysfunction since these conditions can be readily treated. This should start with spirometry before and (if obstructed) after a bronchodilator to screen for asthma. A flow-volume loop should also be performed and if inspiratory notching is observed, vocal cord dysfunction should be suspected. In athletes with exertional cough and normal spirometry, a bronchoprovocation study should be performed. If available, a eucapneic voluntary hyperventilation study is the preferred test to identify athletes with exercise-induced bronchospasm. If unavailable, then a methacholine challenge test is an alternative.

If there is no evidence of asthma or vocal cord dysfunction in athletes with persistent dyspnea on exertion following COVID infection, a cardiopulmonary exercise test should be considered. This is an under-utilized test that can be extremely helpful in the evaluation of unexplained dyspnea.

Long-COVID disability determination

For some patients, impairment from long-COVID symptoms can be disabling. Most organizations require objective evidence of impairment before granting permanent disability. In general, subjective symptoms such as fatigue and pain must have objective correlates on diagnostic testing to qualify for disability. Patients with cardiac symptoms, such as chest pain, palpitations, dizziness, or dyspnea should undergo appropriate cardiovascular tests to determine if there is objective evidence of impairment. These tests could include echocardiograms, tilt tests, or cardiac stress tests.

Patients with pulmonary symptoms such as cough or dyspnea on exertion should undergo appropriate pulmonary diagnostic tests to determine if there is objective evidence of pulmonary impairment. These tests should include pulmonary function tests (spirometry, lung volumes, diffusing capacity). If these are normal and disability is still being considered, a cardiopulmonary exercise testing (CPET) should be performed.

Patients seeking disability for brain fog should be evaluated for objective evidence of cognitive impairment with neuropsychological testing.

Long-COVID prevention

The best way to prevent long-COVID symptoms is to prevent COVID infection. All persons should be recommended to get a bivalent COVID vaccine. Not only does vaccination reduce the chance of becoming infected in the first place but those who get infected despite being vaccinated are less likely to develop long-COVID symptoms than those who were never vaccinated. Those with risk factors for long-COVID such as being older, obese, or smokers should continue to take precautions against acute COVID infection including wearing masks in crowded indoor settings and avoiding contact with other people with acute infections. It is important to emphasis that recovery from a previous COVID infection is not protective because repeated COVID infection is an independent risk for developing long-COVID symptoms.

Long-COVID is very real and very common. But by listening to our patients and by using a symptom-driven approach to evaluation and rehabilitation, we can improve their lives.

May 26, 2023

Categories
Inpatient Practice Medical Economics Outpatient Practice

U.S. Physicians Are Working Fewer Hours Per Week

A recent study in JAMA Internal Medicine showed that the number of hours physicians work per week has fallen significantly over the past 20 years. The data was derived from the U.S. Census Bureau’s Current Population Survey that included 87,297 monthly surveys of physicians between 2001 and 2021. During this 20-year period, the average number of hours worked per week has steadily fallen.

In the study, respondents were asked how many total hours they worked at all jobs during the previous week. The average weekly work hours from 2001 – 2003 were compared to average weekly work hours from 2019 – 2021. Overall, the average physician worked 52.6 hours per week in 2001 – 2003 and this number dropped to 48.6 hours per week in 2019 – 2021. When only physicians working full-time were included, the work hours decreased from 55.6 hours per week in 2001 – 2003 to 51.1 hours per week in 2019 – 2021.

There has been a change in work hours by physician age. In the time period 2001 – 2003, the youngest physicians (age 35 – 44) worked the most hours per week, followed by middle aged physicians (age 45 – 54), and then older physicians (age 55 – 64). In the more recent time period of 2019 – 2021, the opposite was true – older physicians (age 55 – 64) worked the more hours per week than younger physicians.

On average, male physicians currently work more hours per week (49.7 hours) than female physicians (46.8 hours). However, this gap has been narrowing with a gender difference of 5.3 hours per week in 2001 – 2003 versus a gender difference of 2.9 hours per week in 2019 – 2021. Differences in the percentage of women in different specialties may be responsible for some of the gender difference in hours worked per week. Other physician demographic variables did not differ significantly in the current number of hours worked per week including race, country of origin, urban vs. rural, and dual household earners versus single household earners.

The 2023 Medscape Physician Compensation Report surveyed 10,011 physicians between October 7, 2022 and January 17, 2023. The report found that there is substantial variation in physician work hours among different specialties. Hospital-based specialties that tend to involve patient care at night and on weekends work the most hours per week including critical care, general surgery, cardiology, and nephrology. On the other hand, outpatient specialties that generally do not require seeing patients at night or on weekends had the lowest work hours per week including allergy, dermatology, and ophthalmology. Emergency medicine also had a low number of hours worked per week, owing to the shift work nature of the specialty.

A problem with the Medscape survey is that all of the information is self-reported and thus susceptible to either over-estimation or under-estimation. Furthermore, the survey is voluntary and the physicians who choose to report data may not be truly representative of the population of physicians as a whole. Nevertheless, the recent Medscape data for work hours by specialty are remarkably similar to a 2011 study published in the Archives of Internal Medicine.

At the onset of the COVID-19 pandemic (during the 2nd quarter of 2020), the average number of hours physicians worked per week fell as elective procedures were canceled. However, weekly work hours quickly rebounded by the 3rd quarter of 2020 as shown in the graph below derived from data from the recent study in JAMA Internal Medicine. Notably, over the the 24 quarters from 2016 through 2021, the overall trend has been for physician work weeks to become shorter.

Do work week hours correlate with income?

Intuitively, one might assume that specialties with longer work weeks also have higher incomes. However, the 2023 Medscape Physician Compensation Survey indicates that there is little relationship between the number of hours worked per week and the annual compensation by specialty. The graph below shows average number of hours worked per week in red and annual compensation in blue for 29 specialties.

By combining the data from the two graphs above, we can calculate the average income per work-week hour. Note that this is not same as hourly compensation – that would require dividing the income per work-week hour by the number of weeks worked per year. The Medscape Physician Compensation Survey did not report the number of work vs. vacation weeks per year by specialty so true hourly compensation cannot be determined. The graph below shows that plastic surgeons, orthopedic surgeons, dermatologists, and radiologists have the highest income per work-week hour. Infectious disease specialists, family practitioners, pediatricians, and general internists have the lowest compensation per work-week hour. Notably, family medicine, pediatrics, and general internal medicine have shorter residencies (3 years) than the other specialties.

As stated in a previous post, the data for infectious disease is particularly alarming. Physicians specializing in infectious disease have the lowest income per work week hour of all 29 specialties in the Medscape Physician Compensation Survey. In order to become board-certified in infectious disease, a physician must first complete a 3-year internal medicine residency and then complete a 2-year infectious disease fellowship. However, infectious disease specialists have both a lower total annual income and a lower income per work week hour than general internists. The implication is that an infectious disease specialist is financially penalized for doing a 2-year fellowship after internal medicine residency. As a result, many infectious disease specialists are either supplementing their income by working part-time as hospitalists or are leaving the specialty of infectious disease altogether to work as general internists or hospitalists. Because of the nature of physician billing and RVU determination, it is not possible for infectious disease specialists to increase their income by professional billing alone. There is an urgent need for U.S. hospitals to financially supplement their infectious disease specialists in order to preserve the infectious disease physician workforce.

Physicians are working fewer hours but are they happier?

The Medscape Physician Compensation Report found that 73% of physicians would choose medicine again if they were just now starting their career. However, the Medscape survey five years ago found that 77% of physicians would choose medicine again, indicating that physicians are less satisfied with their careers now than five years ago.

Undoubtably, the COVID pandemic has had an impact on physician job satisfaction. During the pandemic, many physicians retired early or left the workforce for other jobs. In 2019, there were 989,684 clinically active physicians practicing in the United States. In 2021 that number fell to 923,419, a 6.7% decrease. Hopefully, as the pandemic winds down and the practice of medicine gets back to normal, the exodus of physicians from the profession will slow.

The continued creep in paperwork and administrative tasks is a dissatisfying factor for many doctors – physicians reported spending an average of 15.5 hours per week on these chores, of which 9 hours are for electronic medical record documentation. Advances in artificial intelligence technology offers hope that the use of electronic medical records will be streamlined in the near future, giving physicians more time to engage in direct patient care. Over the past decade, there have been increasing concerns raised about the extent of physician burnout. Long work hours have been suggested to be a cause of physician burnout but the data suggests that physicians are less satisfied despite working fewer hours than in the past.

What about nurse practitioners and physician assistants?

The large number of retiring physicians coupled with reduced physician work week hours indicates that the overall supply of physician services is declining. Over the past decade, this has been offset by an increase in nurse practitioners. It is far less expensive to train a physician assistant or nurse practitioner (6 years education post-high school) compared to a physician (11 to 16 years education post-high school, depending on specialty). Many services traditionally performed by physicians can be equally or near-equally performed by PAs and NPs. However, specialized medical care and complex procedures still require the additional training and experience of physician specialists and so there is a limit to the degree that PAs and NPs can substitute for physicians.

Are the numbers good or bad?

The reduction in physician work hours is both good and bad. It indicates an improvement in a profession that has historically been seen as arduously time-consuming. But it also implies reduced availability of physician services to the general population. In the future, reduction in administrative and paperwork time coupled with strategic utilization of NPs and PAs could allow physicians to enjoy a good lifestyle while still ensuring that Americans have access to the best possible healthcare.

May 2, 2023

Categories
Outpatient Practice

Enrolling Your Patient In Hospice

Managing death is a normal part of internal medicine and family medicine practice. The one thing that all of our patients have in common is that they eventually die. When death is expected, due to a terminal condition, hospice is an option. Hospice is popular – over the past 20 years, hospice use by Medicare beneficiaries who are nearing death has increased from 22.9% in 2020 to 51.6% in 2019. However, too often we either refer patients to hospice too late in their disease or do not refer them at all. For 30 years, I specialized in the care of patients with idiopathic pulmonary fibrosis, a disease with a life expectancy of 3-5 years unless a patient could get a lung transplant. Hospice referrals were commonplace in my practice. Recently, former president, Jimmy Carter, entered hospice and this has rekindled the public conversation about hospice.

American’s preferences about death

A 2017 Kaiser Family Foundation survey found that there is a discrepancy between how Americans want to die versus how they actually do die. 71% of Americans believe that “helping people die without pain, discomfort, and stress” is the most important priority whereas only 19% believe that “preventing death and extending life as long as possible” should be the top healthcare priority. However, only 37% of Americans believe that the current healthcare system places the right amount of emphasis on these priorities. When it comes to hospice care, 70% of Americans report knowing at least a little about hospice and of these, 85% have a positive opinion about hospice.

When asked about the importance of different factors regarding death, Americans prioritize quality over quantity. Most important is ensuring that family members are not financially burdened by one’s healthcare. Least important was living as long as possible. However, there are notable racial/ethnic differences: only 18% of White Americans believe that “living as long as possible” is extremely important whereas 28% of Hispanic Americans and 45% of Black Americans believe that “living was long as possible” is extremely important. These differences can affect how different racial/ethnic groups view hospice and their willingness to enroll in hospice.

 

Only 11% of all Americans report discussing end-of-life care with their physician; for Americans over age 65, that percentage only rises to 22%. On the other hand, 92% of Americans report that they would feel comfortable discussing end-of-life care with a doctor or other healthcare provider. Overall, 27% of Americans have written end-of-life directives; for those age 65 or older, 51% have written advance directives. Regarding where we prefer to die, 71% of Americans would prefer to die in their own home; 9% prefer to die in a hospital, 7% prefer an inpatient hospice, and 1% prefer a nursing home.

In reality, most people do not die in their preferred location. A 2019 study in the New England Journal of Medicine found that for the first time in over 100 years, more Americans die at home than in a hospital. However, only 30.7% of Americans died at home, meaning that more than half of the people who wanted to die at home died somewhere else. The study found that 29.8% of Americans died in a hospital, 20.8% died in a nursing home, and 8.3% died in a hospice facility.

What does hospice do?

A patient’s hospice benefits depends on their health insurance coverage. Because 72.5% of Americans die after age 65, most deaths occur when people are covered by Medicare. For people younger than age 65 covered by commercial health insurance policies, accidents, suicide, homicide, and COVID cause the majority of deaths and as a result, relatively few deaths in people with commercial insurance are amenable to hospice care. However, commercial insurance policies often provide very different hospice benefits compared to Medicare. For example, Anthem Blue Cross & Blue Shield allows enrollment in hospice for up to 12 months prior to death (compared to 6 months for Medicare) and allows concurrent use of disease-modifying treatments (not allowed by Medicare).

Medicare’s hospice benefit falls under Medicare Part A. To qualify for hospice under Medicare, patients must meet 3 criteria:

  1. Two physicians (both the patient’s regular physician and the hospice physician) must certify that the patient is terminally ill and expected to live less than 6 months.
  2. The patient accepts that the care will change from curative care to palliative care.
  3. The patient signs a statement agreeing to accept hospice care instead of other forms of Medicare services for the terminal condition.

The patient’s costs of hospice under Medicare are generally lower than the patient’s cost of usual medical care. Secondary insurance can provide additional coverage. Specific to Medicare:

  • There is no cost to the patient for hospice care.
  • The patient has a 5% co-pay for outpatient medications (including those for pain and palliation).
  • The patient has a 5% co-pay for respite care.
  • Regular Medicare benefits cover the cost of treating medical conditions not related to the terminal condition.
  • Hospice does not cover regular nursing home costs for those patients who already reside in a nursing home.
  • Once in hospice, Medicare will no longer pay for other services such as:
    • Treatments and prescription medications intended to cure the patient’s terminal condition.
    • Care by any physician or provider not set up by the hospice team. The patient can still see their regular doctor or nurse practitioner if the patient chooses him or her to be the attending medical professional to supervise their hospice care.
    • Emergency department care, inpatient care, or ambulance services unless these are arranged by the patient’s hospice provider.

Medicare’s hospice benefit is quite comprehensive and covers many services that most physicians are unaware of including:

  • Doctors’ services.
  • Nursing and medical services.
  • Durable medical equipment for pain relief and symptom management.
  • Medical supplies, like bandages or catheters.
  • Drugs for pain and symptom management.
  • Aide and homemaker services.
  • Physical therapy.
  • Occupational therapy.
  • Speech therapy.
  • Social services.
  • Dietary counseling.
  • Spiritual and grief counseling (for both the patient and their family).
  • Short-term inpatient care for pain and symptom management.
  • Inpatient respite care up to 5 days per stay (respite care allows  the usual caregiver, such as a family member or friend, to have a rest from providing care).
  • Other pain and palliative treatments as determined by the hospice providers.

Selecting a hospice provider

In many smaller communities and rural areas, selecting a hospice is easy since there may only be one option. In larger communities, there are many different hospice providers to chose from. One resource is Medicare’s Hospice Compare website that lists Medicare-approved hospices in your area and includes a star rating based on previous family caregiver CAHPS surveys. Often, patients will prefer a specific hospice based on past experiences of family members or friends. When enrolling a patient in hospice, there are several questions for the physician to ask himself/herself:

Will I be the hospice physician of record? There are generally 2 options, either be the physician responsible for hospice care or transfer care to the hospice medical director. There are advantages and disadvantages to both options. Being the hospice physician of record allows you to continue your doctor-patient relationship and the patients often prefer to have their hospice care overseen by a physician that they know and trust. However, this role comes with a great deal of responsibility. You have to be comfortable prescribing medications used for pain and palliative care and you have to be available by phone 24 hours a day/7 days a week. Generally, the hospice will have its own standard hospice admission orders, including medications and standard dosing; however, conditions change frequently and although hospice nurses and pharmacists are often very good at recommending medication changes, the responsibility for them ultimately resides with the ordering physician. In addition, the hospice nurses who are on-site at the patient’s home do not want to have to call an answering service and wait for a rotating on-call physician to call them back. When I have been the hospice physician of record for my patients, I gave my cell phone number to the hospice nurses and was on call every night and weekend for that patient while in hospice. On the other hand, having the hospice medical director assume attending physician responsibilities relieves you of having to be available at all times and usually, the medical director is more experienced with the use and dosing of pain and palliative medications. Even if you defer the hospice medical care to the hospice medical director, you can still see the patient for medical conditions unrelated to the terminal condition; however, you must attach the GW-modifier to the CPT code when billing for the encounter.

Will your medical malpractice insurance policy cover you? Physicians in private practice who purchase malpractice policies from a commercial insurance company usually have few or no restrictions regarding where they practice medicine. But hospital-employed physicians are frequently covered by hospital self-insurance plans. These plans often restrict coverage to medical care provided at hospital-owned or affiliated locations. As an example, my malpractice insurance was provided by our hospital, that was self-insured. I had to get special approval from our hospital’s insurance administrator to see patients for home visits, including home hospice care as the hospice attending physician of record. Malpractice insurance coverage for other locations, such as respite facilities or inpatient hospice facilities, may also be required.

Who is the hospice medical director? Frequently, the medical director of a hospice and the other hospice-affiliated physicians will have done pain and palliative medicine fellowships. However, this is not a legal requirement and consequently, some hospice medical directors do not have formal training in palliative care. All to often, physicians just write an order to “Consult hospice” without thinking about the physician who will be responsible for overseeing medical care for the patient. You should find out who the hospice physicians are for the hospice organization that you consult and then use the same judiciousness that you would use if you were consulting any other physician or medical group.

For-profit versus nonprofit hospices. In 2020, 73% of hospice organizations in the U.S. were for-profit. Although many for-profit hospices are excellent, the literature shows that on aggregate, there are some important differences between for-profit and nonprofit hospices. Overall, for-profit hospices tend to have a narrower range of services, less comprehensive bereavement services, lower staff:patient ratios, and less professionalized staff. A study in this month’s JAMA Internal Medicine found that for-profit hospices had significantly lower patient and family satisfaction scores than nonprofit hospices. The profit status of a hospice should never be the sole determinant in choosing a hospice for a patient but it may at least be worth checking the star rating on Medicare’s website when considering a specific for-profit hospice.

Where is respite care provided? Home hospice supplements care from family and friends but does not replace that care. As patients become more incapacitated from a terminal disease, the care demands on family members can be overwhelming at times. Respite care allows those family caregivers to have a break for several days by temporarily admitting the patient to an inpatient hospice facility, nursing facility, community center, or adult daycare center. If the hospice is affiliated with a poorly run respite facility, then respite care can paradoxically increase the stress on family members if the patient has a bad experience while in respite care.

What inpatient hospice care is available? For some patients, care in the last days of a terminal illness simply cannot be effectively provided in the home. This was frequently the case with my patients transitioning from being inpatients in the intensive care unit directly to hospice where death was expected within two or three days. Some hospitals have on-site hospice units but if a given hospice organization is not affiliated with that particular unit, the patient may have to go to an unfamiliar facility, sometime even in a different community. This can result in the patient spending their final few days far away from family and friends.

What medications and treatments will be discontinued? When a patient enters hospice under Medicare, treatments intended to cure the terminal condition are discontinued. This includes chemotherapy medications for patients with cancer. Some commercial insurance companies will permit these medications to be continued. Hospice providers are paid a per diem rate by Medicare and that per diem rate includes covering the expected cost of pain and palliative care medications. Hospice does not cover medications for other co-morbid conditions, such as diabetes and hypertension. These medications are covered by the patient’s co-insurance or Part D plan. However, the hospice physician or pharmacist will generally try to eliminate medications when possible in order to avoid detrimental consequences of poly pharmacy. For example, drugs to prevent osteoporosis or to lower cholesterol are generally no longer necessary when a patient has weeks to live. In my practice, drugs used to treat idiopathic pulmonary fibrosis typically cost about $100,000 per year and Medicare-covered hospices will not pay for these medications as the cost of the medications exceed the total per diem that the hospice receives for all hospice services. Therefore, patients dying of pulmonary fibrosis need to understand that these drugs will usually be discontinued in hospice, similar to chemotherapy drugs for patients with cancer. This can sometimes be tricky when patients are enrolled in hospice for conditions such as end-stage heart failure: are the ACE inhibitor, beta blocker, and diuretic being prescribed to treat the underlying terminal condition or are they being prescribed to relieve shortness of breath? Be sure that there is a clear understanding of what drugs the hospice will discontinue up front so that there are no surprises for the patient later.

Timing the hospice referral. Too many people (and physicians) consider the role of hospice as only providing care in the final days of life. Although this is an important role, hospice is also designed to give patients the best quality of life in the time that they have left. Hospice services such as physical therapy, occupational therapy, speech therapy, and dietician counseling can greatly improve a terminally ill patient’s quality of life in the weeks and months before death. In addition, durable medical equipment provided through hospice can improve the comfort and safety of the patient’s home environment. Simple items such as bedside commodes, shower seats, hospital beds, and oxygen concentrators can be invaluable to terminally ill patients and their families. I can’t remember ever referring patients to hospice too early but I have referred them to hospice too late. In the United States, 50% of hospice patients die within 3 weeks of enrollment and one third die within 1 week of enrollment. These patients do not get the full benefit of hospice. Ideally, hospice referral should be made when you estimate that the patient’s life expectancy is about 6 months. If the patient rallies and improves or stabilizes during that time, then hospice care can be put on hold for a period of time.

Set patient expectations. The proximate cause of death in patients with cancer, COPD, dementia, or idiopathic pulmonary fibrosis is often not the underlying terminal condition but instead an infection, such as pneumonia or urinary infection. When discussing hospice referral with a terminally ill patient, it is important to discuss how patients die with a specific disease so that family members do not panic and call the emergency squad when a dying patient develops a cough and fever in their final days. For example, patients with lung cancer do not all die exactly the same; some will gradually become comatose and die but others will suddenly have a pulmonary embolism, a cardiac arrhythmia, pneumonia, or a stroke. Patients and family members often have preconceived ideas about how people die from movies and TV and if the patient’s condition does not match those ideas, then it can cause confusion and fear.

Palliative medicine consultation can help. Physicians specializing in palliative medicine are often affiliated with hospice organizations but they can do much, much more. They can often provide counseling and treatment long before a patient’s disease advances to having only a 6-month life expectancy. Palliative medicine specialists can also help patients and families understand hospice and help with the timing of hospice referral. There is more to palliative medicine than just pain management.

Final thoughts

Referring a patient to hospice is not about giving up on the patient. It is about redirecting care from curative intent to palliative intent. Not all hospice organizations are equal and the best hospice provider for one patient may not be the best for a different patient.

April 27, 2023

Categories
Outpatient Practice

Telemedicine In The Post-COVID Era

During the COVID pandemic, most physicians used telemedicine to some extent in their outpatient practices. Many of us even used it for inpatient care. Now that the worst of the pandemic is behind us, many regulatory agencies are adopting restrictions on when telemedicine can and cannot be used. There are as many opinions about telemedicine as there are doctors in the U.S. Some practitioners are strong adopters and prefer telemedicine over in-person encounters. Other practitioners dislike telemedicine and will not use it in any situation. Most of us fall somewhere in-between… telemedicine encounters are sometimes the best option and in-person encounters are sometimes the best option.

What the DEA says

Last week, the Drug Enforcement Agency (DEA) proposed new regulations about the use of telemedicine for prescribing controlled medications. During the COVID pandemic, these rules were relaxed in order to ensure that patients could get needed prescription medications without risking COVID exposure during trips to physician offices. The new rules are for the initial prescription of schedule III-V drugs and for the initial prescription of buprenorphine for opioid-use disorder. The regulation states that for the initial prescription of these drugs, a 30-day supply can be prescribed by telemedicine but the patient must have an in-person visit with the prescribing physician within that initial 30-day period. After that first in-person visit, the medications can then be prescribed by telemedicine without a requirement for additional in-person physician visits. A caveat is that if the patient has previously had an in-person visit with that practitioner at anytime in the past, they are not required to have an additional in-person visit after initial prescription of these drugs by telemedicine. In other words, what the regulation says is that to prescribe more than 30 days of schedule III-V drugs or buprenorphine, a practitioner must have at least one in-person visit with a physical examination before or shortly after the prescription. There has been a lot of misinformation that the regulation requires an in-person visit to the prescribing practitioner every 30 days and this is not true. As long as the practitioner has seen the patient in the office one time, the practitioner can prescribe these drugs by telemedicine for as many months as necessary.

Schedule III drugs include codeine, anabolic steroids, ketamine, and testosterone. Schedule IV drugs include Xanax, Valium, Ativan, Ambien, and Tramadol. Schedule V drugs include Lomotil and Lyrica.

Buprenorphine is used to treat opioid-use disorders. It is often prescribed in combination with naloxone; the combination drug is called Suboxone. Although buprenorphine is itself an opioid, Suboxone has relatively little euphoric effect and is used to help prevent opioid withdrawal. The ability to prescribe buprenorphine by telemedicine allows physicians who treat substance abuse disorders to get patients started on treatment immediately. This can be a great advantage in opioid-dependent patients who have transportation barriers or who seek treatment for their addiction on weekends or evenings. Telemedicine for buprenorphine prescription is likely underutilized. The DEA reported that during the COVID pandemic in 2021, there were a total of 1,929,151 Medicare Part D buprenorphine prescriptions associated with 1,332,353 Medicare beneficiaries. Of these prescriptions, 11,956 were prescribed during telemedicine. In other words, only 0.43% of all buprenorphine prescriptions were made by telemedicine.

Schedule II drugs have different DEA regulations. These drugs include opioids, Ritalin, and Adderall. Schedule II drugs cannot be initially prescribed during a telemedicine encounter and initial prescriptions for these medications must be made during an in-person encounter. The new DEA regulations only address the initial prescription for schedule II drugs. These regulations do not prohibit using telemedicine for schedule II refills, as long as there has been at least one previous in-person visit.

What the state medical boards say

The DEA regulations address what controlled drugs can legally be prescribed by telemedicine. Each state’s medical board issues additional regulations that dictate when telemedicine can and cannot be performed. Because these regulations vary from one state to another, physicians need to be familiar with the specific regulations in the state(s) that they are licensed in.

Telemedicine encounters are legally considered to occur where the patient is located and not where the doctor is located. State medical boards have different rules about the legalities of telemedicine when a patient is located in a different state than the doctor. In most situations, a doctor must have a state medical license in every state that he/she practices in. In other words, the doctor must be licensed in every state that their patients are in during telemedicine encounters. The interstate medical licensure compact makes cross-state licensing easier but does not eliminate the requirement for multiple state medical licenses when patients are in a different state than their doctor.

What CMS say

The DEA and the state medical boards dictate what can be legally prescribed during telemedicine and when telemedicine is allowed. CMS dictates when Medicare will reimburse physicians for telemedicine encounters. During the COVID pandemic, CMS relaxed rules about the use of telemedicine for Medicare patients as part of the public health emergency declaration. The public health emergency is set to expire on May 11, 2023. However, when Congress passed the Consolidated Appropriations Act of 2023, they extended some of the telemedicine flexibilities through the end of calendar year 2023. So, for the rest of this year, physicians can continue to perform telemedicine visits with Medicare patients and get paid. Telephone calls are not considered to be telemedicine encounters by CMS so telemedicine encounters must include both audio and video communication. Each commercial insurance company makes their own rules about reimbursement of physician services but they generally follow Medicare’s rules.

What malpractice insurance companies say

For telemedicine to be viable, it must not only be legally allowed and reimbursable, but it must also be covered by the physician’s medical malpractice insurance. Prior to the COVID pandemic, not every malpractice insurance carrier embraced telemedicine and some did not even offer telemedicine coverage. Most malpractice carriers now either include telemedicine in the regular malpractice insurance policy or offer it as an add-on to the standard policy. With the pandemic winding down, it is important for every physician who uses telemedicine to be sure that their policy covers telemedicine after the public health emergency expires in May 2023.

Because telemedicine encounters legally occur in the state that the patient is physically present in, if the physician does perform inter-state telemedicine, they not only need a license in that second state but they also need malpractice coverage in that state. For example, if a physician has an office in Ohio but wants to perform telemedicine encounters for patients who spend the winter in Florida, that physician needs an Ohio and a Florida medical license and also needs Ohio and Florida malpractice coverage. There are substantial differences in the cost of malpractice premiums in different states with Florida being one of the most expensive. So, in this example, unless the physician has a very large number of patients in Florida, the additional cost of malpractice coverage in Florida to be able to perform telemedicine visits may be too great to justify doing telemedicine for patients in Florida.

The use of telemedicine during COVID

A survey by the American Medical Association published in 2022 found that 85% of U.S. physicians were using telemedicine during the COVID pandemic. 60% of physicians reported that they believed that telemedicine enabled them to provide high quality medical care. 54% of physicians reported that telemedicine improved their job satisfaction. 44% of physicians believed that telemedicine decreased the cost of care.

The National Health Interview Survey during the COVID pandemic in 2021 reported that 37% of American adults used telemedicine the the preceding twelve months. The highest utilization was in Whites (39%) and American Indian/Native Alaskans (41%). The lowest utilization was in Hispanics, Black, and Asians (all 33%). Women (42%) used telemedicine more frequently than men (32%). Telemedicine use was also higher in Americans who were older, had higher incomes, and had higher educational attainment. Geography also makes a difference: 40% of adults living in large metropolitan regions used telemedicine versus 28% in rural areas. A survey of 307,000 patients by the Mayo Clinic in 2022 found that patients were equally satisfied with telemedicine visits as they were with in-person visits.

There is a learning curve to doing telemedicine – both on the part of the physician and on the part of the patient. Many patients struggled doing their first telemedicine encounters. But usually after a couple of encounters, they got the hang of using their computer, tablet, or phone to do telemedicine and their proficiency improved. It became clear that providing patients with instructions about how to do telemedicine before the encounter was essential. During the first months of using telemedicine, I had patients try to do their encounters while shopping at the grocery store and even while driving their car (!!!!).

Where should telemedicine go from here?

From the various surveys of telemedicine during COVID, it is clear that telemedicine is preferred by some patients and not others. It is also preferred by some physicians and not others. Intuitively, many physicians would have predicted that telemedicine would be more enthusiastically adopted by rural patients than urban patients because of the geographic distances that must be surmounted to get to the physician office. Intuitively, many physicians would have also predicted that telemedicine would be more enthusiastically adopted by younger patients than older patients because of familiarity with technology. It turns out that just the opposite was true. In my own practice, I had many patients who lacked internet access (or had too low of bandwidth) in their homes and lived in areas with marginal cell phone service – reception was often good enough to do audio phone calls but not good enough to do effective video. These patients were simply unable to do telemedicine encounters.

Regardless of patient preferences, there are some specialties that lend themselves better than others for telemedicine. For example, a cardiologist who specializes in valvular heart disease needs to be able to do an in-person physical examination of the heart with most patient encounters. On the other hand, a cardiologist who specializes in lipid management does not have the same need to do a regular in-person physical examinations. Each physician needs to decide for himself or herself about how necessary a regular physical exam is for their clinical practice. In addition to physical examinations, some medical conditions require regular in-office testing that is typically done at the same time as their physician office visit. EKGs, chest X-rays, hemoglobin A-1Cs, and urine drug screens are examples. Telemedicine is less useful for patients with these conditions.

So, when will telemedicine be most useful in the post-COVID era?

  • When patients prefer telemedicine over in-person encounters
  • When physical examination adds relatively little value to the encounter
  • When in-office procedures are not a usual part of the physician office visit
  • When patients are physically located in the same state as the physician (or in a state in which the physician has a medical license and malpractice coverage)
  • When patients have sufficient skill, technology, and internet bandwidth to effectively complete telemedicine encounters
  • For follow-up encounters for prescription of controlled substances after an initial in-person visit

In addition, telemedicine requires that the physician be capable and comfortable with telemedicine. This includes having HIPAA-compliant audiovisual communication software that can interface with their electronic medical record. It also includes having office staff that are equally capable and comfortable with telemedicine.

What is the best way to schedule telemedicine encounters?

There are several ways to incorporate telemedicine encounters into the outpatient schedule. The three most common are dedicated telemedicine schedules, interspersed telemedicine schedules, and blended schedules.

  • Dedicated telemedicine schedules. This allows a physician to see only telemedicine patients on a given day or half-day. For example, a physician might do in-person office visits 4 days a week and then on the 5th day do telemedicine encounters only.
    • Pros: The advantage of scheduling an entire day or half-day of telemedicine encounters is that the physician can use less office space and less office staff. There is no need for exam rooms, a parking lot, or a waiting room. Patients can often be registered in batch the day of or the day before the telemedicine encounter thus eliminating the need for dedicated registration staff throughout the entire workday. Moreover, the registration staff can often work from home, which facilitates part-time work and can improve job satisfaction for staff who would otherwise have a long commute to the office. Usually, a single medical assistant or nurse can prep the encounter by updating medical history information in the electronic medical record and also perform check-out tasks including scheduling tests or procedures ordered by the physician. This is also a great option when a physician is required to be physically present for supervision purposes; for example, during pulmonary rehabilitation, during hyperbaric oxygen treatments, or during cardiac stress testing. These procedures are often performed in areas that are not equipped for in-person outpatient office visits but that can be used for telemedicine.
    • Cons: There has to be a critical mass of patients to set up a telemedicine-only schedule. Because the nurse does not need to obtain vital signs and the doctor does not need to perform a physical exam, the encounters can be shorter than a regular in-person office visit. This can result in more patients seen in a full-day or half-day schedule. If the physician does not have a sufficient number of patients who are able and willing to do telemedicine, then there may not be enough patients to fill an entire day’s schedule. There also may be limited ability to accommodate patients needing urgent same-day in-person office visits for acute medical conditions.
  • Interspersed telemedicine schedules. In this model, the physician has some in-person office visits alternating with telemedicine visits during the same day.
    • Pros: This model gives flexibility. Patients who unexpectedly cannot arrange transportation to the office can be converted to telemedicine visits to avoid cancelations. This model is also preferable when the physician has an insufficient number of telemedicine patients to fill an entire day or half-day schedule. By carefully scheduling telemedicine encounters in-between in-person encounters, a physician who previously needed 4 exam rooms for optimal operational efficiency might be able to get by with only 2 or 3 exam rooms, thus reducing overhead expenses. Patients frequently call the office for medical advice or because of acute illnesses. Many physicians provide a great deal of medical care over the phone and get paid little or nothing for those patient calls. Having the ability of the office staff to screen patient calls and convert those that can appropriately be telemedicine encounters can improve  revenue and also improve patient care by allowing the physician to see as well as hear the patient.
    • Cons: There is less efficiency savings since the physician has to maintain a fully staffed office and a sufficient number of exam rooms, just as they would for a full schedule of in-person office visits.
  • Blended schedules. In this model, the physician has some days with dedicated telemedicine-only schedules. On other days, there is an interspersed schedule with some in-person and some telemedicine visits.
    • Pros: This model has the advantages of both types of schedules. The physician does not need the parking, exam rooms, or office staff on days that there is a telemedicine-only schedule thus reducing overhead expenses. On the other hand, in-person visits can be converted to telemedicine encounters at the last minute when patients are unable to arrange transportation or in event of bad weather, thus reducing cancelation rates. Patient sick calls can be converted into billable telemedicine encounters.
    • Cons: There has to be a sufficient number of patients to warrant a full day or half-day dedicated exclusively to telemedicine.

The future of telemedicine is what we make it

The COVID pandemic gave patients and doctors a taste of telemedicine. However, the U.S. healthcare system had to adopt telemedicine quite quickly and with rapid adoption there was inevitably problems. Many medical practices went through several telemedicine software systems trying to find the best system for their particular practice. We are now entering a time when we can more thoughtfully select telemedicine software and we can plan for the efficient use of telemedicine in the future.

Most physicians will likely continue to utilize telemedicine as a component of their outpatient practice. Telemedicine fills a needed practice efficiency gap by reducing last minute cancelation rates and by reducing barriers to healthcare for those patients who are immobile or live great distances from their doctor. When possible, physician practices should adopt blended schedules in order to reduce overhead expenses and convert phone calls into billable telemedicine encounters while still maintaining the capability of doing in-person visits when medically appropriate.

But we also need to know if telemedicine will continue to be reimbursed by Medicare and commercial insurance companies. Since the current telemedicine reimbursement rules expire at the end of 2023, we need to advocate for CMS to make telemedicine reimbursement permanent. Otherwise, it is difficult to justify purchasing expensive telemedicine videoconferencing software and camera systems. It is also risky to schedule telemedicine encounters beyond December 31, 2023 since we do not yet know if these encounters will be reimbursable in 2024.

Telemedicine cannot and should not replace all in-person office visits. But neither should we abandon telemedicine completely as the COVID pandemic (hopefully) fades away.

March 3, 2023

Categories
Inpatient Practice Outpatient Practice

Supplemental Oxygen: Sometimes Less Is Better

Supplemental oxygen is one of the most commonly prescribed treatments in the hospital. Patients with acute or chronic lung disease depend on supplemental oxygen to stay alive. As a natural and necessary substance, oxygen would seem like a safe thing to prescribe for patients that need it. But sometimes too much of a necessary thing can be harmful. So, when is too much oxygen bad for patients? We can take a lesson from vitamins.

The supplemental vitamin industry is based on the tenet that if our bodies need a small amount of a vitamin to live, then it must follow that by supplementing larger and larger amounts of that vitamin, our bodies will function better and better. Americans love this concept and we spend $30 billion every year on supplements. But frequently, too much of a good thing turns out to be a bad thing. Take Vitamin A – it is necessary for normal health and without vitamin A, we can lose night vision and become immunocompromised. A small amount of vitamin A in our diet keeps our bodies functioning normally. But if a person ingests too much vitamin A from supplements or from a dietary source that is high in it (such as polar bear liver), death can result from vitamin A toxicity. The same is true for water: drinking too little and a person dies of dehydration but drink too much and a person dies of hyponatremia. For decades, we thought oxygen was somehow different and that it was always better to err on the side of prescribing too much oxygen than risk prescribing too little. It turns out that we were wrong.

There are a lot of different oxygen delivery options: home concentrators, portable concentrators, compressed oxygen gas tanks, liquid oxygen, etc. In the hospital, oxygen is usually delivered through a medical gas panel that will have outlets for medical grade oxygen, regular air, and wall suction. The oxygen that comes out of these outlets is generally at a maximum pressure of 55 PSI. Conventional oxygen delivery devices (nasal cannulas and simple face masks) in the hospital usually are capped at a maximum flow rate of 15 liters per minute. Heated high flow nasal cannulas can deliver very high oxygen flow rates of up to 60 liters per minute. Mechanical ventilators can blend pure oxygen with room air to achieve anywhere from 21% to 100% inhaled oxygen concentrations (FiO2). As a result, physicians can adjust the amount of supplemental oxygen that a patient receives from a very small amount to a very large amount.

In the past, when EMS personnel would bring a patient with shortness of breath to the emergency department, they would put a mask on that patient and turn the oxygen up to a 15-liter flow rate to achieve close to 100% inhaled oxygen. In the hospitals, doctors would prescribe a high flow of oxygen and then not decrease that flow rate until a patient’s condition was improving and it was time to wean the oxygen down. In our emergency departments, ICUs, operating rooms, and hospital wards, we would give the patient as much oxygen as it took to raise their blood oxygen saturation to 100% and leave the oxygen at that flow rate for hours or days. But it turns out that we were probably harming patients by doing so.

In the past several years, there have been studies showing that prescribing excessively high oxygen flow rates can worsen patient outcomes in adults with lung disease. A study published in this week’s JAMA extended those findings to children. This study looked at 1,567 children, ages 1 – 4 years old, at 14 hospitals in Australia and New Zealand who had respiratory failure. The children were randomly assigned to receive either standard oxygen therapy or high-flow oxygen therapy. The high-flow group received as high as 40 liters per minute, depending on body weight. The standard-flow group received up to 2 liters per minute that was titrated to keep the blood oxygen saturation above 92%. The children receiving high-flow oxygen had a significantly longer length of hospital stay (1.77 vs. 1.50 days), longer duration of time on oxygen (1.07 vs 0.75 days), and higher rate of admission to the ICU (12.5% vs 6.9%).

Other studies have shown that excessive supplemental oxygen can be harmful in adults. A study of 429 patients given supplemental oxygen after resuscitation for cardiac arrest found that 40.7% of those receiving a conservative oxygen flow rate died but 50% of those receiving a liberal (i.e., higher) oxygen flow rate died. A meta-analysis study of 16,037 critically ill patients treated with conservative vs. liberal oxygen therapy found that those treated with liberal oxygen therapy (higher flow rates) had a higher mortality than those treated with conservative oxygen therapy (lower flow rates). A 2022 study of inpatients receiving supplemental oxygen during COPD exacerbations found that those who had arterial oxygen saturations of 88 – 92% had the lowest mortality rate and those patients given greater amounts of supplemental oxygen to maintain arterial oxygen saturation > 92% had significantly higher mortality rates.

For patients having out-of-hospital cardiac arrest, the conservative oxygen approach may be risky, however, A 2022 study from Australia found that cardiac arrest patients treated by EMS personnel with a conservative oxygen strategy (targeting a blood oxygen saturation of 90 – 94%) had a higher mortality rate than those patients treated with a liberal oxygen strategy (targeting a blood oxygen saturation of 98 – 100%). Because there was a tendency to frequently undershoot the oxygen saturation in conservative oxygen therapy group, it is possible that even brief periods of low oxygen saturations can be harmful in patients immediately after a cardiac arrest which may have resulted in the higher mortality rate.

Adverse effects of too much oxygen

So, if oxygen is so necessary for us, how can it harm us? There are several effects of excessive oxygen that can result in harm:

  • Oxygen toxicity. High oxygen concentrations can damage lung cells by oxidant injury resulting from the production of substances such as superoxide anion, hydroxyl radical, and hydrogen peroxide. We sometimes see this in the intensive care unit in respiratory failure patients who require 100% oxygen concentrations for long periods of time who get into a vicious cycle of pneumonia requiring supplemental oxygen and then the high oxygen concentrations cause further lung damage resulting in the patients needing even higher oxygen concentrations in order to get enough oxygen into the blood stream to keep the body’s organs alive. These patients can end up with permanent lung scarring and never get off of the mechanical ventilator. Lung damage depends on how long a person is exposed to high concentrations of oxygen – brief periods are less harmful than breathing very high concentrations of oxygen for longer periods of time. This mainly applies to those patients in the ICU left on 60% – 100% inhaled oxygen for several days.
  • Drug-induced lung disease. Many drugs can cause damage to the lung resulting in inflammation and scar in the lungs (interstitial lung disease). Certain drugs are particularly likely to do this when combined with high concentrations of inhaled oxygen. The two biggest offenders are bleomycin (used in cancer chemotherapy) and amiodarone (used in heart rhythm disorders). When a patient is breathing room air, these drugs are usually safe but when breathing high concentrations of oxygen, these drugs can become very toxic. Bleomycin is particularly notable because the risk of pulmonary toxicity from breathing high oxygen concentrations can persist for many years after the patient was given bleomycin.
  • Radiation-induced lung disease. Excessively high amounts of radiation to the chest can cause interstitial lung disease but moderate amounts can be used safely to treat lung cancer. However, when a patient is using high oxygen concentrations, those moderate amounts of radiation can cause interstitial lung disease. Thus, like amiodarone and bleomycin, oxygen therapy can increase the risk of radiation-induced pulmonary fibrosis.
  • Adsorptive atelectasis. Room air contains about 21% oxygen and 78% nitrogen. Oxygen readily passes from the alveoli of the lungs (air sacks) into the blood stream but nitrogen does not cross as easily. Because of this, nitrogen in the air helps keep the alveoli of the lungs propped open, similar to using PEEP (positive end-expiratory pressure) on a mechanical ventilator, thus preventing atelectasis. When a person breathes very high concentrations of oxygen, the nitrogen in the alveoli gets “washed out” and as a result, the lungs are more prone to developing atelectasis that can in turn worsen oxygenation. Once again, the patient can get into a vicious cycle of worsened blood oxygen levels leading to the doctor increasing the supplemental oxygen concentration leading to worsened atelectasis leading back to worsened blood oxygen levels.
  • Carbon dioxide retention. Our breathing rate is determined by the blood oxygen level (PO2) and carbon dioxide level (PCO2). Patients with COPD are sometimes less sensitive to rising carbon dioxide levels and more dependent on the blood oxygen level to determine respiratory rates. In this setting, by giving too much supplemental oxygen, the patient can lose their respiratory drive and begin to hypoventilate, resulting in a high blood carbon dioxide level. Although this effect on PCO2 levels is usually small, it can be important when combined with other things that can suppress the respiratory drive centers, such as sedatives and opioids.
  • Longer oxygen weaning times. When a patient with acute respiratory failure in the hospital begins to improve, the doctor will generally order the respiratory therapist to wean the oxygen off (or back down to the patient’s normal home supplemental oxygen flow rate). The respiratory therapist will then reduce the oxygen flow rate by 1-2 liters per minute, wait a couple of hours, recheck the blood oxygen saturation, reduce the flow rate by another 1-2 liters, etc. It takes less time to wean oxygen off if a patient is on less oxygen to begin with than if they are receiving higher flow rates of oxygen. The doctors generally wait until the oxygen is completely off (or down to the normal flow rate the patient uses at home) before the patient is allowed to be discharged. As a result, longer oxygen weaning times can sometimes lengthen the patient’s hospital stay.

So, what is the right amount of supplemental oxygen?

Our bodies require oxygen to live. If we don’t get enough oxygen, our tissues become damaged. On the other hand, too much oxygen is also bad for our bodies. Here is what we can do in our hospitals to draw the right balance between not enough and too much:

  1. In emergencies, it is better to give too much than to give too little. In settings such as cardiac arrest, myocardial infarction, and stroke, brief periods of low blood oxygen levels can worsen clinical outcomes. If too much emphasis is placed on using the least amount of supplemental oxygen, there is a greater risk of undershooting the oxygen flow rate and causing low blood oxygen levels for seconds or minutes. Situations where this applies include during transport of cardiac arrest or stroke patients by emergency squads, during CPR for cardiopulmonary arrest, and during the first hours of a myocardial infarction or stroke.
  2. Target a blood oxygen saturation of 88 – 92%. After the initial resuscitation, titrate the supplemental oxygen flow rate (or the FiO2 on the mechanical ventilator) to the least amount necessary to keep the oxygen saturation between 88 – 92%. For years, physicians have written orders to “Wean supplemental oxygen to maintain oxygen saturation > 92%”. This is probably too high and our default oxygen weaning orders in our electronic medical records need to be revised.
  3. In the ICU, use other measures to improve oxygenation when patients need more than 60% FiO2. This could include increasing the PEEP on the ventilator, using prone ventilation, giving sedatives, controlling fever, or using neuromuscular blockade.
  4. Avoid unnecessary use of 100% FiO2 during surgery. In the past, anesthesiologists would sometimes leave patients on 100% FiO2 throughout surgical operations so that there would be no risk of the patient desaturating during surgery. Not only can this increase the risk of post-operative absorptive atelectasis, but it can be particularly harmful if patients have previously received sensitizing drugs or radiation. One of my colleagues was a physician who had been treated with bleomycin years previously for lymphoma. He underwent an elective gall bladder surgery and was left on 100% FiO2 during the procedure. He developed acute lung injury post-operatively and died from bleomycin-induced acute oxygen toxicity.
  5. We need pharmacologic 2,3-DPG. 2,3-Disphosphoglycerate (2,3-DPG) is a chemical in red blood cells that helps hemoglobin molecules release oxygen. Physiologically, this can result in a  shift in the oxy-hemoglobin dissociation curve to the right. This means that oxygen can pop off of hemoglobin easier, allowing the red blood cells to release more of their oxygen to tissues that need it. In other words, 2,3-DPG allows the tissues to get by when there is less oxygen in the blood. Normally, red blood cells release about 30% of their oxygen when they pass through tissues; 2,3-DPG allows them to release more than 30%. What is important to our bodies is not the amount of oxygen in the blood but rather the amount of oxygen that our tissues get. 2,3-DPG allows our tissues to function normally when the blood oxygen saturation is lower. If we could increase red blood cell 2,3-DPG levels pharmacologically, we could use lower amounts of supplemental oxygen in patients with acute respiratory failure.
  6. Not everyone with a low oxygen saturation needs supplemental oxygen. Insurance will not pay for supplemental oxygen unless a patient has an oxygen saturation of < 89%, either at rest, during exercise, or during sleep. But that does not mean that every patient with brief oxygen saturations < 89% needs supplemental oxygen. The LOTT study showed that COPD patients with oxygen saturations 89 – 92% at rest that desaturated to 80 – 90% with exercise had no benefit from supplemental oxygen, including death rates, hospitalization rates, COPD exacerbations, and quality of life. In my own clinical practice, I have also been hesitant to prescribe oxygen in hyperemic patients who are at fire risk, including those who smoke, have smokers in the home, or use gas cooking stoves. These patients are often more likely to be injured or die from fire caused by supplemental oxygen than they are to die from hypoxemia without supplemental oxygen.

It’s time for auto-titrating oxygen delivery devices

Auto-titrating oxygen devices adjust the oxygen flow rate based on a patient’s oxygen saturation. A 2019 meta-analysis showed that compared to manual oxygen titration, these devices shortened hospital length of stay by shortening oxygen weaning times. A 2020 study of outpatients found that by using auto-titrating oxygen devices, patients had improved 6-minute walk distances and improved dyspnea. It is not surprising that these devices are effective in the hospital – a respiratory therapist cannot be in a patient’s hospital room 24 hours a day to constantly adjust the supplement oxygen flow rate but the auto-titrating oxygen delivery device can. Not only can these devices reduce excessive supplemental oxygen flow rates in hospitalized patients, but they can also reduce excessive oxygen flow rates in outpatients.

The cost to hospitals to buy and implement auto-titrating oxygen delivery devices would be considerable. However, these costs could potentially be off-set by shortened hospital length of stays and by reduction in utilization of respiratory therapists. These devices would also take some of the guesswork out of ordering oxygen flow rates for hospitalized patients resulting in a more standardized and consistent use of supplemental oxygen by hospitalists and intensivists. In addition, there is a potential for a reduction in hospital mortality rates by avoiding excessively high amounts of supplemental oxygen.

There is both an art of medicine and a science of medicine. It is time to harness science to guide the use of supplemental oxygen.

January 26, 2023

Categories
Outpatient Practice Public Health

A Pulmonologist’s Opinion About Gas Ranges

Recently, there have been health concerns raised about gas ranges. This has led some cities to prohibit their installation in new homes, including Los Angeles, New York and San Francisco. I am interested in these health concerns for two reasons. First, as a pulmonologist, I want to be sure that the people in our community are safe from health risks. Second, I am getting ready to buy a new range for myself. So, what are the health risks of gas ranges and should you be worried about them?

The basics of cooking ranges

First, some definitions. Many people use the terms “range”, “stove”, and “oven” interchangeably. Technically, an oven is the enclosed box that you bake in. A stove is the surface heating area that you heat pots on. A range is when a stove and an oven are combined into a single appliance. Sometimes the term “cooktop” is used when the stove is separate from the oven. For the purpose of this post, I will use the term “range” for the appliance that combines an oven with a stove.

In the United States, there are essentially four types of ranges: electric, gas, duel fuel, and induction. Electric ranges work by passing an electric current through a metal coil that heats up as it creates resistance to that current. These electric coils (“burners”) can be exposed on the top of the stove or covered underneath a flat sheet of glass. Electric ranges also use electric heating elements inside the ovens. Gas ranges work by igniting a jet of natural gas. The resultant flame is used to heat pots and pans on the stove. Gas ranges also use gas flames inside the oven for baking purposes. Duel fuel ranges use gas flames for the stove to heat pots and pans but use electric heating elements in the oven for baking purposes. Induction ranges work by using electricity to create a magnetic field on the stove that then heats up any pot or pan placed on the stove that contains iron or steel. Induction ranges generally use a standard electric heating element in the oven for baking purposes.

For many years, electric ranges dominated the U.S. appliance market. However, gas ranges are preferred by many cooks because of the better control over the amount of heat generated, for example, allowing the cooking surface to instantly increase or decrease in temperature. Duel fuel ranges combine the advantages of the gas stove for surface cooking with the more even heating of an electric oven for baking. Induction ranges offer the advantages of using electricity, thus avoiding an open flame, while also offering the advantage of being able to instantly control the temperature applied to the pot or pan. Consumer Reports found that induction ranges out-performed electric and gas ranges in cooking tests.

As a general rule, when things burn, the resultant products of combustion are bad for our lungs. Whether that be burning cigarettes, military burn pits, house fires, or indoor wood/charcoal cooking. Natural gas is often called “clean-burning” because it does not produce visible smoke, unlike a wood fire or charcoal fire. However, just because we cannot see or smell the products of combustion from natural gas does not mean that those products of combustion cannot hurt us.

What is natural gas?

Natural gas is a type of fossil fuel produced by the decay of long-dead plants. It accumulates in large gas pockets deep underground and then can be removed by drilling gas wells into those pockets. The main component of natural gas is methane which in pure form, creates water and carbon dioxide when it burns. However, natural gas is not pure methane and instead contains small amounts of other gases and chemicals. The typical components of natural gas include:

  • Methane
  • Ethane
  • Butane
  • Propane
  • Hydrogen sulfide
  • Carbon dioxide
  • Oxygen
  • Nitrogen
  • Trace elements: helium, hydrogen, Xenon, and Neon

When natural gas is burned, these components produce new gases, including carbon dioxide, nitrous oxide, methane, carbon monoxide, formaldehyde, nitrogen dioxide, and particulate matter. Many of these gases can cause lung disease.

Carbon dioxide

It is estimated that a typical U.S. family cooking with a gas stove produces slightly less than a pound of carbon dioxide each day from the combustion of natural gas. This is about the same amount of carbon dioxide produced by coal or gas power plants to generate the amount of electricity required to cook using an electric range or an induction range. So, we don’t really produce more carbon dioxide by using a gas range but we do concentrate that carbon dioxide inside our homes. To illustrate this, I measured the concentration of carbon dioxide in my kitchen before and during the use of my gas range. At baseline, the carbon dioxide level in my kitchen was 646 parts per million.

After turning on 4 burners on the gas stove for five minutes, the carbon dioxide level increased to 1609 parts per million.

I then turned on the overhead exhaust fan for five minutes and the carbon dioxide level fell to 821 parts per million.

Carbon dioxide is a by-product of living animals. Our bodies normally produce carbon dioxide that we exhale with every breath. If the levels of carbon dioxide in our bloodstream builds up, it can be toxic to the human body. Similarly, if the level of carbon dioxide in the air increases and then we breath that air, we can suffer ill health. NIOSH considers breathing air containing over 5,000 parts per million over the course of a 10-hour day to be toxic and over 30,000 parts per million for a 15-minute period to be toxic. It would require cooking for a long period of time in a poorly ventilated kitchen to reach these levels using a gas range.

Carbon monoxide

Like carbon dioxide, carbon monoxide is produced when things burn. However, carbon monoxide is much more toxic to humans than carbon dioxide. It is an invisible, odorless gas. When inhaled, it tightly binds to the hemoglobin molecules in our red blood cells thus preventing oxygen from binding to those hemoglobin molecules. Without oxygen, the cells in our bodies suffocate. We all inhale small amounts of carbon monoxide from our environments so there are always low levels of carbon monoxide in our blood stream. Cigarette smokers have higher levels of blood carbon monoxide than non-smokers. Very high levels of carbon monoxide are fatal. This is how most people die in house fires or die by suicide from running their car in a closed garage. Lower levels of carbon monoxide can cause headaches, ringing in the ears, and confusion. Every house with a gas range should have a carbon monoxide detector installed.

Nitrogen dioxide

The air we breathe is mostly made up of nitrogen – it constitutes about 80% of the gases in air. Nitrogen gas is considered inert – it does not cause any direct harm to the body except when nitrogen dissolved in the bloodstream “boils” and creates nitrogen gas bubbles in the tissues when SCUBA divers ascend too rapidly and get the bends. But when gases are burned, pure nitrogen can be converted into nitrogen oxides. One of these is nitrogen dioxide, which can be very toxic and poses the greatest health risks to our lungs from gas ranges.

Nitrogen dioxide can also build up from decay of certain types of plant materials. In pulmonary medicine, an important result of nitrogen dioxide toxicity is in “silo-filler’s disease”. This occurs when nitrogen dioxide builds up inside of poorly ventilated silos storing silage. If a farm worker enters that silo and inhales high concentrations of nitrogen dioxide, the lungs can become injured. In the short-term this can result in ARDS (acute respiratory distress syndrome), where the lungs are damaged and fill up with inflammation and fluid, thus blocking air from getting into the lung’s alveoli (air sacks) where oxygen normally transfers into the bloodstream. In the long-term, small airways in lungs exposed to high concentrations of nitrogen dioxide can fill up with scar tissue, resulting in permanent blockage of air getting to the alveoli. This is called “bronchiolitis obliterans“. A famous event resulting in pulmonary nitrogen dioxide toxicity occurred in Cleveland in 1929. At that time, a fire arose in the Cleveland Clinic in a room where large amount of old x-rays films that were made of nitrocellulose were stored. The resultant nitrogen dioxide gas produced by the burning x-ray films resulted in 129 deaths, including one of the Clinic’s founders, Dr. John Philips.

In lower concentrations, nitrogen dioxide can irritate small airways causing asthma. This can be particularly insidious because nitrogen dioxide does not cause allergic reactions, unlike many allergic triggers of asthma such as cats dander or pollens. For this reason, most people with asthma worsened by nitrogen dioxide do not realize that it is their gas cooking range that is making them sick. A 2013 meta-analysis of 41 studies found that indoor gas stove use increases the incidence of asthma in children. A recent study estimated that 12.7% of childhood asthma is due to nitrogen dioxide and other by gases produced by gas ranges. Adults with asthma may be less affected by gas ranges than children based on a 2003 study of 445 subjects.

Formaldehyde

Every middle school student who accidentally opened the jar of preserved frogs in biology class knows how noxious inhaling formaldehyde is. It is another toxic by-product of natural gas combustion. Formaldehyde is also produced by burning cigarettes and can be released by wood adhesives in newly constructed houses. It is often one of the suspected culprits in patients with “sick building syndrome”. When inhaled, formaldehyde can cause eye irritation, nose irritation, throat irritation, and cough. Meta-analyses in 2010 and 2018 showed that environmental formaldehyde in homes is associated with asthma in children. Formaldehyde is also considered a carcinogen. A 2018 study found that using even 1 gas burner turned on low increased air formaldehyde levels above safe thresholds.

Particulate matter

Natural gas is often called “clean-burning” but that is not exactly true. Tiny particles (< 10 μm) of soot are produced when gas is burned, even if those particles cannot be easily seen with the naked eye. Breathing particulate matter can cause cough and worsened asthma. It is one of the main causes of respiratory symptoms when outdoor air quality is poor, due to air pollution. Some particulate matter is produced from food as it is cooked, however, gas ranges produce particulate matter even if there is no food being cooked.

Fire

Accidental house fires are another harmful consequence of gas ranges. It surprises me that there are not more of these. Spilled cooking oil or a dishtowel accidentally dropped onto an open flame can quickly develop into a kitchen fire. The National Fire Protection Association estimates that there are 179,500 fires due to cooking in the United States, accounting for 49% of all house fires. Ranges account for 61% of cooking-related house fires and 87% of cooking-related fire deaths. Interestingly, electric ranges are more likely to cause house fires than gas ranges. There is very little research in fire risk from induction ranges compared to electric or gas ranges but given that induction cooktops produce no heat if a pan is removed, it would seem that there would be less risk of fire if the induction range was accidentally left on after cooking. Grease fires may also be less frequent given the absence of a flame (gas ranges) or hot electric coil (electric ranges).

Fire is a particular risk for people with lung disease who require supplemental oxygen. As pulmonologists, we caution our patients to never use their oxygen in the kitchen when using a gas range. However, there is no risk of fire when using supplemental oxygen around an induction range.

Thermal injuries

Both electric ranges and gas ranges produce high heat. Small children who don’t know any better can get severe hand and finger burns from reaching up to an electric or gas burner. Even experienced cooks often burn their hands from accidentally touching a hot burner. Induction ranges substantially reduce the risk of burns. Only the bottom of a pot or pan gets hot; the surface of the range does not heat up. So unless a toddler touches the bottom of a pan, there is no danger of thermal injury with an induction range.

So, what are the downsides of induction ranges?

The main problem with induction ranges is that they are expensive. The cheapest electric or gas range is several hundred dollars less than the cheapest induction range. However, a provision of the Inflation Reduction Act to discourage gas ranges provides a tax credit of up to $840 to replace gas ranges with electric or induction ranges. This only applies to Americans with lower incomes. Those with middle incomes can qualify for a reduced amount of the tax credit while those with higher incomes are not eligible for any tax credit. Although induction ranges can be expensive, it is anticipated that prices will come down in the future as the market for induction ranges increases. Consumer Reports recently rated ranges and found that the top rated induction ranges cost about the same as the top rated gas or electric ranges. The least expensive of the top four rated induction ranges costs $1,200.

A second problem with induction ranges is that the bottom of pots and pans must contain iron or steel. Copper, purely ceramic, aluminum, and glass cookware will not work with an induction range. If you have to buy all new steel/iron plated cookware, it can considerably add to the cost of a new induction range. An easy way to determine if a given pot or pan will work is to see if a refrigerator magnet sticks to the bottom.

A final problem with induction ranges is that you cannot generate extremely high heat. This is especially a problem for restaurants using very high heat output gas flames for wok cooking. These high heat levels are generally not achievable with an induction cooktop. However, there are now “induction woks” being marketed that surround the wok bowl with an induction element, thus permitting cooking temperatures similar as can be produced using high-output gas burners.

“I have a gas stove. What can I do to reduce the risk of harm?”

If you have a gas range, the most important step you can take is to ventilate the kitchen. This can mean opening kitchen windows when the weather outside permits. If you have a fan that you can put in that window, even better. If you have an exhaust hood above your range, then turn it on when cooking. An exhaust hood that blows air outside is optimal. If a child in the house has asthma, then try to keep that child out of the kitchen when cooking. If you are unsure of how effective your kitchen ventilation is, you can buy a home CO2 monitor for about $80. If the CO2 level increases significantly when you are cooking, then your ventilation is likely inadequate.

A second way of minimizing harm from a gas range is to use other kitchen appliances for cooking instead of the range whenever possible. For example, an electric kettle can be used to heat water rather than boiling water in a pot on the gas stove. An air fryer can replace the use of a gas oven for many foods. And a slow cooker can be used instead of the range range for chili, stews, and soups.

“Should I switch out my gas range for an induction range?”

The short answer is that most people do not need to ditch their gas ranges if they already have one. However, if your kitchen is poorly ventilated or lacks an exhaust fan over the range, then replacing your gas range with an electric or an induction range may make sense. Also, if there are children in the house, the health risks of a gas range increase significantly, especially if one of the children has asthma or another lung disease. If someone in the home uses supplemental oxygen, then getting rid of the gas range can reduce the risk of a house fire, particularly if the oxygen-user does the cooking.

For climate-conscious people, changing gas to electric or induction ranges can appear on the surface to be the more responsible choice. However, if your local electricity producer uses fossil fuel power plants, then there really is not much advantage in electric or induction ranges since the overall CO2 production is similar. Here in Ohio, we can choose our electricity provider and for several years, I have purchased electricity from providers that only produce electricity from wind and solar sources. So for me, an induction range will result in less overall CO2 production than a gas range. People in other parts of the country where the electrical grid sources electricity from hydroelectric power-plants can also reduce their CO2 footprint by switching from gas to electric or induction ranges.

For me, I don’t have any lung disease and no longer have children in the house. I like breathing clean air in the home and I like to minimize my personal CO2 footprint. However, I also like the ability to easily regulate the cooking temperature that in the past was only achievable with a gas stove but is now achievable with induction stoves. We are building a new house and had to decide what kind of appliances to install. So, I just ordered my new induction range.

January 15, 2023

Categories
Outpatient Practice

Does Your Hospital Need A Cancer Survivorship Clinic?

Prior to 1946, cancer was a surgical disease. If a cancer could not be completely removed during an operation, then it was incurable. But in 1946, two Yale University pharmacologists, Dr. Louis Goodman and Dr. Alfred Gilman, published their findings that by treating a patient dying of lymphoma with nitrogen mustard, the patient’s tumors shrank. The impetus for their experiment was the observation during World War I that soldiers who survived mustard gas attacks developed low white blood cell counts and were susceptible to infections. Goodman and Gilman hypothesized that the same chemical used in gas warfare could treat white blood cell malignancies. Thus, the era of cancer chemotherapy was born.

When I was a medical student 40 years ago, chemotherapy rarely cured anyone – it merely postponed dying from cancer by a few months. However, since then, the number of chemotherapy drugs has dramatically increased. Now, we also have immunotherapies, driver-directed therapies, and hormonal therapies to treat cancers. These treatments are much more effective than early chemotherapies and can not only offer the hope of long-term suppression of cancer but can also often cure cancer. And each of these treatments has its own set of short-term and long-term complications. Currently, there are 18.1 million cancer survivors in the United States and that number is expected to grow to 22.5 million over the next ten years. Of those cancer survivors, 16.3 million will live for more than 5 years. The good news is that we now have more people surviving cancer than ever before but the bad news is that we now have more people living with the side effects of cancer treatment than ever before.

Historically, oncologists were in the business of treating cancer. Once cancer was cured, the oncologist discharged the patient to the care of their primary care physician so that the oncologist could focus on their next patient with newly diagnosed cancer. But primary care physicians are largely untrained in managing the medical complications attendant to cancer treatment. As a result, we have an unfilled gap in medical care – patients in a no-man’s land of medical problems that their primary care physician is unfamiliar with and that their oncologist often places a lower priority on. This unfilled gap is cancer survivorship.

There are four major components to cancer survivorship care:

  1. Surveillance. Cancer can recur and early detection of recurrence leads to early treatment of recurrence which in turn leads to the best long-term survival. However, the  surveillance monitoring guidelines frequently change and each type of cancer requires different radiographic or blood test monitoring.
  2. Prevention. Cancer treatments can cause medical conditions by themselves but they can also make patients more susceptible to other medical problems. Preventive care can often avert these problems.
  3. Treatment side effects. Every cancer therapy has its own set of side effects and if untreated, these side effects can often be debilitating.
  4. Coordination of care. The management of cancer survivors can be complicated, often requiring multiple specialists simultaneously.

A cancer survivorship clinic should ideally incorporate all four of these components.

Surveillance

Cancer screening falls squarely in the purview of the primary care physician. Family physicians and general internists are accustomed to being responsible for ordering routine screening mammograms, pap smears, and colonoscopies. But once a patient is treated for a cancer, the guidelines for those tests change and primary care physicians are often uncertain what tests to order and how often to order them. Current guidelines include the following:

  • Breast cancer. Survivors should have an office visit with history and physical examination every 3-6 months for the first three years, every 6-12 months for the next two years, and annually thereafter. A diagnostic mammogram should be performed annually for the first 3-5 years and then a screening mammogram performed annually thereafter. All women with breast cancer should be offered genetic testing and genetic counseling.
  • Prostate cancer. Prostate cancer is unique among cancers because there is a wide spectrum of severity. Some prostate cancers grow so slowly that they do not require any treatment whereas others can rapidly metastasize and be fatal. The PSA (prostate-specific antigen) blood test is the mainstay of prostate cancer surveillance. For patients with localized disease, it should be tested every 6-12 months for the first 5 years and then annually thereafter. For patients with more extensive disease, it should be tested every 3-6 months.
  • Colon cancer. For patients with stage I disease, a colonoscopy should be performed 1 year after surgery and then every 3 years thereafter. Patients with stage II or III disease should also have regular colonoscopy but should additionally have a history and physical examination plus a CEA blood test every 3-6 months as well as a CT scan of the chest/abdomen/pelvis every 6-12 months.
  • Lung cancer. The chest CT is the mainstay of surveillance for lung cancer survivors and, along with a history & physical examination, should be performed every 6 months for the first two years and then annually thereafter. After five years, changing to a low-dose screening annual chest CT can be considered.
  • Other cancers. There are different surveillance recommendations for melanoma, testicular cancer, lymphoma, thyroid cancer, and brain cancer. The surveillance for every cancer is unique and may require interval history and physical examinations, blood testing, and/or radiographic imaging.

Prevention

Preventive medicine recommendations are fairly similar for all cancer survivors. Healthy living strategies for one cancer are generally the same for other cancers. A healthy diet, weight loss if overweight, regular exercise, and appropriate vaccinations are appropriate for cancer survivors as well as for the general population. Because many cancer survivors may have lingering immunity impairment from chemotherapy, vaccinations are especially important.

Smoking cessation is an essential component of cancer survivorship. Approximately 12-15% of cancer survivors are current smokers. The patient cured of their lung cancer by lobectomy will be at increased risk of a second lung cancer if cigarette smoking continues. Smoking cessation can also help prevent laryngeal cancer, bladder cancer, pancreatic cancer, kidney cancer, esophageal cancer, and others,

As more and more cancers are found to have genetic contributions, genetic testing has become routine in oncology. Ideally, genetic testing be done after genetic counseling but with the widespread availability of gene testing, any provider can order these tests. At the least, referral to a genetic counselor should be made for all patients with abnormal cancer-related genes. Not only can this improve early diagnosis and prevention of other cancers in the patient but it can also improve cancer diagnosis and prevention in susceptible family members.

Treatment side effects

Each kind of cancer has its own specific treatment. And each treatment has its own specific side effects. As the number of cancer treatments has increased exponentially in the past decades, so have the number of treatment side effects. The result is that cancer survivorship has almost become a sub-specialty of its own. To a degree, this has been met by other subspecialties. For example, we now have “onco-nephrologists” who are kidney specialists who sub-specialize in managing the renal complications of cancer treatments. We have “onco-pulmonologists who sub-specialize in pulmonary complications of cancer treatments. Similarly with cardiology, infectious disease, and gastroenterology. But these sub-specialists are few in number and only located in large, tertiary care, academic medical centers. Moreover, their expertise is organ-specific and frequently, cancer survivors have complications affecting more than one organ or affect a part of the body that does not fall under the expertise of the nephrologist, pulmonologist, or cardiologist. Here are some of the most common medical conditions seen in cancer survivors:

  • Osteoporosis. Many cancer treatments can increase the risk of osteoporosis including chemotherapy-induced premature menopause, use of aromatase inhibitors for breast cancer, use of corticosteroids, and use of anti-androgen prostate treatments. Baseline bone density tests at treatment onset followed by regular interval bone density tests should be offered to patients receiving these treatments. Early treatment of osteopenia and osteoporosis can prevent subsequent bone fragility fractures.
  • Fatigue. Cancer survivors can have fatigue for many different reasons including side effects of radiation therapy, surgery, or medications. However, other common causes of fatigue should not be overlooked including thyroid dysfunction, sleep disorders, anemia, depression, and heart disease.
  • Peripheral neuropathy. Many chemotherapy drugs can cause damage to the peripheral nerves. Some of the more common drugs include vincristine, cisplatin, oxaliplatin, bortezomib, and paclitaxel. These are usually “stocking-glove” distribution sensory neuropathies. However, drugs such as vincristine can cause intestinal autonomic neuropathy resulting in constipation. In addition, radiation therapy can result in peripheral neuropathy from injury to nerves within the radiation ports. Peripheral neuropathy management in cancer survivors may include physical therapy, medications (such as duloxetine), and injury prevention (such as daily foot inspections).
  • Pain. Cancer-related pain is often managed by palliative medicine specialists but cancer survivors often have chronic pain, even if their cancer is cured. This often results in patients transferring care from the palliative medicine specialist to a pain management specialist. As with other causes of chronic pain, multimodality comprehensive pain management is considerably more effective than relying solely on pain medications such as opioids.
  • Cardiotoxicity. Patients receiving radiation therapy to the chest region are susceptible to developing pericarditis, cardiomyopathy, coronary artery disease, and valvular heart disease. Anthracycline drugs (such as doxorubicin and daunorubicin), fluorouracil, and trastuzumab can cause heart failure and may require serial cardiac ultrasound testing. Many other chemotherapy drugs can also cause heart disease. The management of drug-induced heart failure is similar to the management of other causes of heart failure.
  • Pulmonary toxicity. Chest radiation and many chemotherapy drugs can cause interstitial lung disease. Bleomycin is particularly notable because it can cause interstitial lung disease with respiratory failure years after treatment if a patient is inadvertently exposed to high oxygen concentrations, for example, while undergoing anesthesia. Driver-directed cancer treatments, such as tyrosine kinase inhibitors, can cause lung damage. Checkpoint inhibitors used as immunotherapy for cancer can also cause pneumonitis. In many cases, pulmonary toxicity can be minimized by early diagnosis and treatment with corticosteroids but patients may require bronchoscopy to exclude infection.
  • Gastrointestinal toxicity. Diarrhea is common with chemotherapy. Pelvic radiation can additionally result in diarrhea or incontinence. Checkpoint inhibitors can cause hepatotoxicity and colitis. In some cases, corticosteroids can relieve symptoms but patients require microbiologic testing of the stool to first exclude infection.
  • Renal toxicity. The kidney can suffer many kinds of injury from cancer treatment. Chemotherapies, checkpoint inhibitors, and driver-directed therapies can all directly cause acute kidney injury. Electrolyte disorders of potassium, sodium, phosphorus, and calcium can result from both cancer treatments or from the underlying cancer. In addition, paraneoplastic glomerular disorders, glomerular injury from tumor lysis syndrome, and glomerular injury from monoclonal gammopathies can occur.
  • Sexual health needs. Sexual dysfunction can result from post-surgical changes, chemotherapy, hormonal therapy, radiation therapy, and  premature menopause. Many cancer survivors are hesitant to initiate discussion about sexual dysfunction so it is important that providers create an environment where patients are comfortable discussing sexual health.
  • Fear of recurrence. About half of cancer survivors have mild to moderate fear or worry that their cancer will come back and 7% of survivors have these fears to a severe degree. This carcinophobia can be emotionally consuming. In mild cases, support groups can be helpful. More severe cases benefit by cognitive behavioral therapy. Other psychosocial issues such as depression, anxiety, and post-traumatic stress disorder are also common.
  • Financial insecurity. It is expensive to have cancer. Frequent office visits, costly medications, costly tests, and unexpected surgeries can be financially devastating, even for those patients with health insurance. In addition, reduced income for both patients and caregivers results from necessary time off work. Hospital financial counselors and social service staff can often be helpful.

Coordination of care

With care simultaneously being provided by physicians from many different specialities, cancer survivors often find themselves asking: “Who is in charge of my medical care?”, especially after cancer treatment has finished. Coordination between the patient’s medical oncologist, surgeon, radiation oncologist, internal medicine specialists, social worker, psychologist, genetic counselor, and neurologist can be challenging. Although primary care physicians are adept at coordination of care for patients with chronic disease, the unique multidisciplinary care needs of cancer survivors can often be overwhelming for the primary care office. Coordination of care can be the responsibility of the medical oncologist in some situations, the primary care physician in some situations, or patient navigators in others. The important thing is that every cancer survivor knows who is coordinating their care and that all of the various providers involved in that patient’s care also know who coordinating care. This is particularly essential to ensure that recommended tests and medication changes actually get done.

Cancer survivorship clinics

So, does your hospital need a cancer survivorship clinic? And if so, who should run it? In some hospitals, cancer survivorship is the purview of the medical oncologist. But the medical needs of cancer survivors can last for years or decades after the cancer is cured and many oncologists simply do not have the bandwidth to meed these needs for dozens or hundreds of cancer survivors while still meeting the needs of patients being actively treated for their cancer. Some primary are providers are able to assume the oversight and coordination of care for cancer survivors. But cancer survivorship care has become fairly specialized with the result that many primary care providers lack the training or experience in the unique chronic care of the cancer survivor.

A solution in some communities is the dedicated cancer survivorship clinic. This could be staffed by an oncologist, a general internist with a special interest in cancer survivorship, a physical medicine specialist, or even an advanced practice provider with training in the care of cancer survivors. Although large cancer specialty hospitals have dedicated survivorship clinics, this is an unmet medical need in most community hospitals.

It is time that medical directors and hospital administrators at community hospitals take responsibility for creating cancer survivorship clinics. One out of every 17 Americans is a cancer survivor and these cancer survivors are often hiding in plain sight in every small community in the United States. A community does not need to have a tertiary care oncology practice in order to support a cancer survivorship clinic. Indeed, such a clinic can be overseen by a general internist or a family medicine physician.

As cancer treatments continue to advance, so do the needs of cancer survivors. It is time that we bring survivorship clinics to our community hospitals.

December 27, 2022

Categories
Outpatient Practice

Who Should Treat Hepatitis C?

An August 2022 study in the MMWR found that only 1 out of 3 people with hepatitis C are getting treated… and all of the patients in the study had health insurance. What are the barriers to treatment and how can we overcome them?

Summary Points:

  • Hepatitis C is common: 2 million Americans have chronic active infection.
  • Hepatitis C is under-treated: only 1 out of 3 insured Americans diagnosed with hepatitis get treated.
  • New therapy regimens have simplified the treatment of hepatitis C
  • It is time for primary care physicians and advance practice providers to treat most patients with hepatitis C

 

Hepatitis C is incredibly common. Worldwide, 100 million people have been infected and 71 million have chronic liver disease from the virus… that’s 1% of the world’s population! Here in the United States, hepatitis C has infected 1.5% of Americans and 2 million Americans have chronic active infection. More than 75% of infected people have no symptoms and do not realize that they are infected. Once initially infected, two-thirds of people go on to have chronic active infection. Of those, about one out of five will develop cirrhosis about 20 – 30 years after the initial infection.  It causes 19,000 deaths per year in the U.S. It is the most common cause of chronic liver disease and is the leading reason for liver transplantation.

Because it is so common and because most patients are initially asymptomatic, the Centers for Disease Control and the United States Preventive Services Task Force both recommend that all adults > 18 years of age be tested at least once for hepatitis C. The screening test is a simple and widely available blood antibody test. If the screening test is positive, then the next step is a blood hepatitis C RNA test to determine if the patient has chronic active infection. If the RNA test is negative, then the patient has resolved the infection and does not have chronic hepatitis C. But if the RNA test is positive, then the patient has a chronic infection and and should be considered for treatment.

Prior to 1991, hepatitis C was incurable. For the next 20 years, alpha interferon and ribavirin were the only available treatments. However, these drugs had significant toxicity, required a very long duration of treatment, and only resulted in cure of 6% of treated patients. Over the past 10 years, new anti-viral drugs have been developed that can cure the vast majority of patients and only require 8 to 12 weeks of treatment. So, why aren’t more people being treated and cured?

There are not enough hepatologists

Unlike most infections, the treatment of hepatitis C has been the realm of hepatologists, rather than infectious disease specialists or primary care physicians. However, hepatologists are relatively few in number. Most hepatologists do a 1-year hepatology fellowship following completion of a 3-year gastroenterology fellowship. Hepatology is a relatively new subspecialty. In 2006, the first board examination for hepatology was offered and there are only 59 hepatology fellowship training programs in the United States. Currently, there are 7,296 U.S. healthcare providers whose self-described practice is > 50% hepatology. However, the majority of these are gastroenterologists and advance practice providers with only a minority being board-certified hepatologists. There is little financial incentive for gastroenterology fellows to train for an extra year to become hepatologists. A study published in the January 2021 edition of Hepatology Communications found that the median total compensation for hepatologists in the U.S. is $320,728 which was less than the total compensation for gastroenterology assistant professors at $329,600. In other words, the reward for doing a hepatology fellowship is that you make less money than you would had you not done the extra year of training.

Most hepatologists practice at a relatively few large, referral hospitals. Consequently, most hospitals do not have a hepatologist on their medical staff, thus requiring patients with hepatitis C to travel long distances in order to be evaluated and treated by a hepatologist. This has resulted in a geographic barrier for most patients and is a contribution to the low rate of infected patients getting treated.

What is so complicated about treating hepatitis C?

Treating most infections is relatively simple: you get a culture, you give an inexpensive antibiotic for 5-7 days, and you’re done. But treating hepatitis C is a lot more complicated and requires specialized testing, counseling, expensive medications, and laboratory follow-up. The current recommendations for treatment are published jointly by the American Association for the Study of Liver Disease and the Infectious Disease Society of America. This is a lengthly document that is daunting for most non-hepatologists. A Simplified HCV Treatment Algorithm for Treatment-Naive Adults Without Cirrhosis is available that summarizes the recommendations in just 1 page:

Initial evaluation. Once a patients are diagnosed with hepatitis C, they need to undergo a series of laboratory tests including:

    • FIB-4 calculation. This is based on the patient’s age and three blood tests (AST, ALT, and platelet count). An on-line calculator is available to easily determine the FIB-4 score.
    •  Cirrhosis assessment. Cirrhosis can be identified by a FIB-4 score > 3.25, liver biopsy, transient elastography (“Fibroscan”), imaging (CT or ultrasound), clinical evidence of cirrhosis, or laboratory test (such as the “Fibrosure” blood test).
    • CBC
    • Liver function tests
    • Glomerular filtration rate
    • Hepatitis C viral load (HCV RNA)
    • HIV test
    • Hepatitis B surface antigen
    • Pregnancy test (for women of childbearing potential)

Treatment regimens. There are 12 drugs approved to treat hepatitis C and choosing among them can be formidable for non-hepatologists. Different drug regimens are used for different viral genotypes. In addition, several drugs that were approved in the past 10 years have been recently discontinued as more effective newer medications have been introduced. The result is that physicians who do not keep up with new developments in hepatitis C medications on a regular basis often feel uneasy prescribing treatments. Fortunately, there are two currently recommended medication treatments for hepatitis C in patients without cirrhosis, regardless of which genotype of hepatitis C patients are infected with:

    1. Mavyret – glecaprevir (300 mg) + pibrentasvir (120 mg) for 8 weeks
    2. Epclusa – sofosbuvir (400 mg) + velpatasvir (100 mg) for 12 weeks.

Laboratory monitoring. The newer hepatitis C medications do not require routine lab monitoring. This is a significant improvement over previous drugs that required regular blood tests during treatment. Because of the possibility of drug interactions, patients with diabetes taking hypoglycemic drugs should have their glucose levels checked periodically and patients taking warfarin should have their INR levels checked periodically.

Post-treatment testing. 12 weeks after completing treatment, patients should have liver enzymes checked. They should also have a hepatitis C RNA level checked at that time to confirm that they are cured. Those patients who continue to have detectable HCV RNA may require referral to a specialist.

The two drugs used to treat hepatitis C are expensive. Mavyret costs $34,000 for an 8-week course if purchased out of pocket ($13,000 to $16,000 if purchased using GoodRx). Eclusa costs $31,000 for a 12-week course ($11,000 to $19,000 if purchased using GoodRx). Because of their expense, most commercial insurance companies require prior authorization when these medications are prescribed and this poses another barrier for non-hepatologists who are less familiar with the drugs.

The simplified recommended treatment regimen for patients with compensated cirrhosis is very similar to that used for patients without cirrhosis with the main difference being that Mavyret can be used for any genotype of hepatitis C but Eclusa can only be used for genotypes 1, 2, 4, 5, & 6. To make things utterly simple, if prescribing Mavyret, the same management protocol can be used whether or not a patient has compensated cirrhosis.

The simplified treatment regimens are applicable to most patients with chronic hepatitis C infection. Patients not eligible for one of the two simplified regimens will likely require referral to a specialist. This includes patients with:

  • Prior hepatitis C treatment
  • End-stage renal disease
  • Decompensated cirrhosis 
  • HIV or HBsAg positive
  • Current pregnancy
  • Known or suspected hepatocellular carcinoma
  • Prior liver transplantation

So, who should treat hepatitis C?

It is clear that the shear number of Americans infected with hepatitis C is too great for all patients to be treated by the country’s relatively few hepatologists. But fortunately, the newer regimens are very protocolized, making their use much simpler that previous regimens. Because of this, two groups of providers are now in position to treat most patients with hepatitis C.

  1. Primary care physicians. In the past, primary care physicians referred patients with hepatitis C to hepatologists or gastroenterologists for treatment. The drugs were toxic, expensive, and required complex regular monitoring. Furthermore, busy primary care physicians did not want to deal with insurance prior authorization for drugs that they were not very familiar with. The simplicity of the new treatment regimens now makes it easier for primary care physicians. All that is required is creation of a hepatitis C order set in the electronic medical record and a fairly straight forward prior authorization that the office nurses can usually do on their own.
  2. Advance practice providers. Treatment regimens that are based on protocols are ideal for nurse practitioners and physician assistants. This can be a great option for larger primary care groups or for hospitals that designate an advance practice provider to specialize as the go-to hepatitis C treatment provider.

A time for change…

In summary, the number one cause of chronic liver disease and number one indication for liver transplantation can now be cured relatively easily. In communities that lack easy access to a trained hepatologist, the newer hepatitis C treatment regimens lend themselves to implementation by either primary care physicians or advance practice providers. In order to improve the numbers of Americans who are cured of hepatitis C before it results in cirrhosis, we must overcome historical barriers to treatment. Our hospitals can help by sponsoring CME programs to train primary care physicians in hepatitis C management and by financially supporting advance practice providers to specialize in hepatitis C management.

September 22, 2022

Categories
Epidemiology Inpatient Practice Outpatient Practice

2022-23 Influenza Season Predictions

You would think that August would bring a lull in the work of U.S. influenza epidemiologists. But August is when we get some of the most important information that predicts what our winter flu season will look like. And the projections are a little scary this year.

The best predictors of North American influenza in our winter is Australian influenza during our summer. Normally, influenza season in Australia starts in April and runs through October, corresponding with winter in the Southern Hemisphere. What happens with influenza in Australia usually fairly closely matches what happens later in the year in the United States. Thus, by examining the epidemiological data from the Australian Department of Health’s Influenza Surveillance, we can predict when influenza cases will start to be seen, what age groups will be affected, what serotypes will be predominant, and what severity will occur here in the United States and Canada.

Recent U.S. influenza seasons

Over the past 3 influenza seasons, we have seen an inverse relationship between COVID cases and influenza. One of the primary reasons for fewer influenza cases when COVID cases increase is social distancing and mask-wearing to prevent COVID. It turns out that these measures help prevent COVID but they are even more effective to help prevent influenza. We can see that effect in the 2019-20, 2020-21, and 2021-22 influenza seasons.

The graph above shows seven previous influenza seasons in the United States. The 2019-20 influenza season (green line) started off quite severe with sustained high numbers of cases from December through March. The onset of the COVID pandemic in the United States in March 2020 marked the closure of schools, work from home initiatives, and public masking. This coincided with a precipitous fall in influenza-like infections at the end of March.

The 2020-21 influenza season (pink line) was the mildest in recent history with only a small peak in cases of influenza-like infections in November and December. At this time, social distancing and masking were more ubiquitous and the COVID vaccines were not yet widely available. It was not until the summer of 2021 that influenza-like infections began to rise – this was a time when COVID vaccines were widely available and it was generally believed that the end of the COVID pandemic was in sight. Consequently, mask mandates were discontinued, children returned to schools, and workers returned to their workplaces. This created conditions that allowed influenza to have a summer rebound.

The 2021-22 season is in red with red triangles. It peaked in December, much earlier than usual. This coincides with the rise in case numbers of the Omicron variant of COVID that caused people to resume masking and social distancing in December. Once these measures to prevent the spread of COVID went back into effect in December 2021, the frequency of influenza-like infections fell.

The exceptional influenza season was the H1N1 outbreak in 2009-10 when cases began to increase in August and peaked in September and October. This represented an unusually early influenza season that caught physicians off-guard. Making matters worse, this particular H1N1 strain had not circulated for decades and was not predicted to appear that season with the result that it was not covered by that season’s flu shots. These factors together resulted in an unusually large number of cases and large numbers of deaths, particularly among younger people who had no natural immunity to H1N1.

What we are learning from Australia

When will influenza season start?

In the last several years, the influenza season in the U.S. has mirrored the influenza season in Australia that occurs earlier in the year. So, what is Australia telling us this year? First, we are likely to see influenza cases start to increase earlier than normal this season. The graph below shows the last several seasons of positive influenza testing in Australia.

The current influenza season is in red. It began much earlier than in past years and also peaked much earlier. Cases began to rise in late April which corresponds to late October in the Northern Hemisphere. Cases peaked in late May in Australia which corresponds to late November in the U.S. By late July, the Australian influenza season was pretty much over – this would correspond to late January in the United States and Canada. So based on these data, we should expect to see influenza cases start to increase in October 2022 with peak numbers in November and December 2022.

How severe will influenza be this year?

Hospitalization data from Australia predicts that this will be an average year with respect to influenza severity. The graph below shows the number of influenza hospitalizations in Australia over the past several seasons. The current season is in red with hospitalizations mimicking the case number graph above. Hospitalizations began to increase in April and were back to baseline by late July. 

Based on this data, in the United States, we should expect influenza-related emergency department visits and hospitalizations to peak in November and December 2022.

What ages will be most affected?

A unique finding during the current Australian influenza season has been the propensity to affect children. The graph below shows the number of laboratory-confirmed influenza cases by age.

The largest case rates have been in people under age 20. This would predict that U.S. pediatricians will be seeing more influenza than U.S. internists this season.

Will the influenza vaccine cover it?

The vast majority of cases of influenza in Australia were influenza A with unusually few cases of influenza B as shown in the graph below.

The seasonal influenza vaccines in Australia this year included the following serotypes:

Egg-based quadrivalent influenza vaccines:

  1. A/Victoria/2570/2019 (H1N1)pdm09-like virus;
  2. A/Darwin/9/2021 (H3N2)-like virus;
  3. B/Austria/1359417/2021-like (B/Victoria lineage) virus; and
  4. B/Phuket/3073/2013-like (B/Yamagata lineage) virus.

Cell-based quadrivalent influenza vaccines:

  1. A/Wisconsin/588/2019 (H1N1)pdm09-like virus;
  2. A/Darwin/6/2021 (H3N2)-like virus;
  3. B/Austria/1359417/2021 (B/Victoria lineage)-like virus; and
  4. B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.

Although it is still too early to be confident of Australian vaccine effectiveness, we can look at whether the strains seen during the flu season corresponded to the strains covered by the influenza vaccines. In all, 97.4% of influenza A (H1N1) isolates were antigenically similar to the vaccine components. 93.2% of influenza A (H3N2) isolates were antigenically similar to the corresponding vaccine components. And all of the influenza B isolates were similar to the corresponding vaccine components. The U.S. quadrivalent influenza vaccine for the 2022-23 season has identical components to the egg-based quadrivalent influenza vaccine used in Australia. Therefore, it is likely that this season’s flu shots will cover the strains of influenza that we are likely to see in North America.

What we should do in the U.S.

Based on the Australian experience, there are several steps that we should take to prepare ourselves for the 2022-23 influenza season:

  1. Start vaccinating early. It takes about 2 weeks for immunity to develop after a flu shot. Therefore, we should insure that most Americans get vaccinated in September this year if case numbers begin to rise in October as anticipated. If cases peak in late November, as expected, then people who wait until December or January to get vaccinated will have waited too long.
  2. Target kids for vaccination. With children being disproportionately affected by influenza in Australia, it is likely that we will see the same trend in the U.S., particularly as schools return to in-person classes.
  3. Prepare for a surge of hospitalizations in November and December. Normally, this is a low-census period for medical admissions in American hospitals. It is also a time when many people get elective surgeries over the winter holidays and before the end of the calendar year to take advantage of annual insurance deductibles. If the early influenza peak occurs as expected, we may need to institute routine pre-op influenza testing for elective surgeries much as was done with COVID testing during the worst of the COVID pandemic.
  4. Anticipate the effect of Thanksgiving travel. Thanksgiving and Christmas holidays are times when many Americans travel to be with family. The Australian influenza season predicts that U.S. influenza cases may be peaking around Thanksgiving. This could result in holiday travel accelerating influenza spread this year.

No one can predict the influenza season with 100% accuracy. But if historical trends follow, then the U.S. will likely experience a similar season as Australia. Given that most Americans are starting to relax as the COVID-19 case numbers fall, we could be especially vulnerable to influenza this year, particularly if it comes early and preferentially affects children as expected.

August 10, 2022