Categories
Outpatient Practice

How To Do A Disability Exam

Physicians have two roles in disability determination: (1) recommending disability as the attending physician of their patients and (2) doing an independent medical examination consultation for disability granting organization (such as an insurance company or Social Security). These are two very different tasks.

First, it important to remember that we as physicians do not grant disability retirement. We can only recommend disability – disability retirement can only be granted by the employer, the insurance company overseeing the disability insurance policy for the employer, or the government agency providing disability benefits. Over the past 30 years, I have filled out hundreds of disability forms for my patients, done dozens of independent medical examinations for insurance companies or employers, and reviewed hundreds of independent medical examinations for organizations that grant disability. Here is what you need to know.

When is a patient disabled?

Put simply, a patient is disabled when they have a physical or mental impairment that prevents them from performing their job. The key words are “their job” – a medical condition that prevents someone from doing one job may not prevent that same person from doing a different job. For example, a partial foot amputation may be disabling for a road construction worker but not disabling for a telemarketer. Usually, disability benefits are granted when an employee can no longer do the job they were hired for, but some companies will not grant disability benefits if an employee can be retrained a different job within the company. For example, a factory worker who develops occupational asthma from a chemical used in manufacturing might be re-trained to work in the shipping department where finished products are stored.

In addition, disability is considered when the employee is unable to perform regular full-time duties despite reasonable accommodation. It is often far less expensive to the employer to provide an accommodation to an employee than to hire a replacement, train that replacement, and face increased disability insurance premiums if the employee goes on disability. As an example, an employer could assign an employee with knee arthritis an office on the first floor so that the employee does not have to walk up multiple flights of stairs every day.

Although there is a lot of variation between different disability-granting organizations, the common requirements to be granted disability include:

  1. The medical condition must either be new since the applicant began employment or if it is a pre-existing condition, it must have worsened since the date of initial employment.
  2. The medical condition must have a diagnosis (or tentative diagnosis). A symptom alone, such as shortness of breath, is generally not grounds for disability unless there is a diagnosis to go along with it (such as COPD).
  3. The medical condition must be of sufficient severity to prevent the applicant from doing their regular employment duties.
  4. The medical condition is expected to be “permanent”. This generally means lasting at least 12 months. In this sense, permanent does not necessarily mean forever.
  5. There must be objective evidence that the condition causes impairment. For this reason, it is very difficult for patients with chronic pain syndromes (migraine headache, fibromyalgia, etc.) to get disability without collaborating x-ray, EMG, or physical examination abnormalities. Similarly, applicants with conditions such as chronic fatigue syndrome that lack abnormalities on diagnostic tests are often denied disability.

The attending physician’s role

When a patient applies for disability through their employer, one of the first steps is for the employer (or employer’s insurance company) to contact the patient’s attending physician to get detailed medical information. Before giving out any information to the employer, the attending physician must confirm that the patient has given permission for release of their medical information. I was almost conned once when a patient’s ex-spouse sent me a letter requesting medical information posing as an employer. However, there was no signed release of information document and when I contacted the patient to clarify the medical information release, I found out that it was all a ploy.

These disability forms are often several pages long and can require as long as a half hour to complete. The time required to fill these forms out is usually not billable to the patient’s regular health insurance company so it is a good idea to have a written office policy for form completion with a fee schedule for filling out disability paperwork. Usually, payment of these fees is required in advance from the patient. If medical records are requested, then a per-page copying charge is also common practice. Although some disability insurance companies will pay a fee for the physician to complete these forms, most of the time it is the patient’s responsibility to pay for form completion. In my own practice, if the form only required a minute or two of my time, I would not bother to bill the patient – it often took more time to create the bill than it did to fill out the form. But for extensive forms, for patients with multiple disability applications, and for requests for extensive photocopies of medical records, I would require payment.

The information required will vary by employer/insurance company but in general, there are several things that they will want to know:

  1. What is your diagnosis? This should be a medical condition and not a just a symptom. If the patient’s work-up is in progress and you are not yet sure of the specific diagnosis, then indicate that the diagnosis is suspected. If the work-up is just beginning, then it is reasonable to report that you require “X” number of weeks to determine a diagnosis – in that situation, the patient can apply for temporary disability pending full medical evaluation.
  2. What are the disabling symptoms? Common symptoms contributing to disability include dyspnea, impaired mobility, visual impairment, angina, fatigue, cognitive impairment, etc.
  3. Is the patient’s medical condition permanent or temporary? Many conditions that are disabling today may improve with a treatment period of 6 months or so. Permanent disability means impairment lasting more than 12 months. Employers will generally be less strict about granting temporary disability benefits and will often approve temporary disability with a simple administrative approval. Permanent disability requires a more extensive process that generally involves getting one or more independent medical examinations and may involve a disability hearing.
  4. When did the condition become disabling? A condition that was disabling before the patient began his/her employment will generally result in denial of disability benefits.

Attending physicians have an inherent conflict of interest when filling out disability paperwork. The physician may not want to disappoint a patient with whom they have longstanding doctor-patient relationship. The physician may get pressured by the patient to help them get disability benefits. Or the physician may fear that the patient will leave the practice if the physician does not support their disability application. Because of this conflict of interest, most employers and disability insurance companies will require an independent medical examination prior to determination of permanent disability.

The independent medical examiner’s role

If the patient’s attending physician recommends disability retirement, the next step in the disability process is usually an independent medical examination (IME). This is done by an impartial physician having no relationship with the patient. The physician should be experienced with the patient’s medical condition and should be knowledgeable about the evaluation of impairment.

Agree on a fee

The IME should be billed to the employer or disability insurance company and not to the patient’s health insurance company. In a large medical practice, this will require you to make prior arrangements with your billing department so that the bill does not inadvertently go out to Medicare or the health insurance company. Most practices will set their fee schedule to charge more than whatever their best paying commercial health insurance contract will pay (anything over that contractural amount is written off). An IME is one of the few times that the physician actually gets paid the amount of their fee schedule. Before agreeing to do an IME, be sure that there is a fee schedule agreement in place. Most IMEs will be a level 4 or level 5 consult. Also, determine up front if additional testing will be covered. Usually, simple office tests such as an EKG or office spirometry will be covered but more extensive testing such as full pulmonary function tests, stress tests, and formal neuropsychological testing requires prior approval.

Review the records

An IME is essentially a consult and like any consult, it starts with a review of the medical records. These can range from a few pages of office notes to thousands of pages of electronic medical record print-outs. My practice was to review these prior to the patient’s office visit and then keep track of the time required. If the records are excessively voluminous, then get an agreement up front about an additional hourly fee for extensive record review.

Do a complete H & P

An IME is usually a comprehensive evaluation and should include a full history, past medical history, review of systems, physical examination, and summary of previous testing. The physical exam should at least cover the areas relevant to the patient’s symptoms. That means documenting a mental status exam in a patient applying for disability due to a psychiatric condition or documenting a cardiac exam in a patient applying for disability due to heart failure. Although it is important to be thorough, when it comes to your final report, more documentation is not necessarily better. I have seen IME reports in excess of 50 pages long with extraneous filler documentation. For example, when reporting a disability applicant’s dietary history, summarize it in 1-2 sentences and don’t list a menu of everything they ate in the past two weeks. Be complete but also be concise.

What is the diagnosis?

The primary diagnoses should be what you have determined that the patient has based on your evaluation. Frequently, your diagnosis may differ from the diagnosis given by the patient’s attending physician(s). Because the IME reports are often sent to the patient’s regular physicians, it is best to word your opinion non-judgmentally. Rather than saying “I determined that the patient has osteoarthritis and disagree with the patient’s treating doctor that she has rheumatoid arthritis”, it is better to state: “My diagnosis is osteoarthritis and I find no evidence of active rheumatoid arthritis at this time.” This allows the patient’s regular doctor to save face and avoids engendering a combative relationship between the doctor and the patient’s employer or disability insurance company.

State why the patient is impaired to perform regular full-time work duties

This generally requires you to have familiarity with the patient’s job description. Simply having a medical condition does not equate to disability; that medical condition must result in a physical or mental impairment that prevents the patient from doing their job. Whenever possible, include objective testing or physical examination findings that confirm impairment. For example, “The claimant has COPD with severe obstruction on spirometry and an oxygen saturation of 82% on room air that indicates a need for supplemental oxygen. The need for oxygen precludes continued work as a furnace repairman”.

Estimate recovery time

Permanent impairment generally implies that a patient will be disabled for more than a year. But that does not always mean that the patient will be disabled forever. For example, a patient with liver failure due to cirrhosis may be disabled today but may be able to return to work two years from now if the patient undergoes liver transplantation. Disability benefit recipients frequently undergo periodic re-evaluation to determine if benefits should be continued or terminated. It is within your purview to advise when such a re-evaluation should occur.

Know where to send the report

The physician performing the IME is being consulted by the employer, insurance company, or government agency that requested the IME. The final report should be addressed to them and not to the patient’s primary care physician or other treating physicians. It is best to not send copies to the patient’s attending physicians – that responsibility usually lies with the organization requesting your IME.

You are not the treating physician

Specialists are accustomed to providing treatment recommendations in consultation reports. An IME is a very different type of consultation. It only involves evaluation and not management. Nor will you be doing any follow-up. Do not prescribe medications.  Do not refer the patient to another specialist. Do not order tests without prior approval by the agency requesting the IME. Do not recommend specific treatments – the agency requesting your IME does not have the authority to prescribe medications or initiate work-ups. However, if you find something potentially life-threatening, the it is appropriate to call the patient’s attending physician to alert them. For example, I once did an IME that included getting a chest X-ray. The X-ray showed a probable undiagnosed lung cancer. I called the patient’s primary care physician so that he could initiate a work-up. I included documentation of the finding and my conversation with the attending physician in my IME report for medical-legal protection of both me and the agency requesting the IME.

Unsuitable for a job does not mean disabled for that job

Unlike conditions such as depression, schizophrenia, and bipolar disorder, personality disorders are rarely grounds for psychiatric disability. However, personality disorders can cause a person to be unsuited for a particular job. For example, a customer service employee with an anti-social personality disorder who punches one of the company’s clients does not warrant disability retirement on the basis of his personality disorder. Personality disorders usually originate in childhood and pre-date employment. One out of ten Americans have a personality disorder – there is not enough money in the U.S. economy to give them all disability retirement.

Similarly, an employee who who develops anxiety because of consistently poor job performance evaluations does not warrant disability retirement on the basis of anxiety disorder. A vegetarian who develops dysthymia when working at a slaughterhouse should not be put on psychiatric disability. These are jobs that they were never suited for in the first place.

Disability determination can be particularly difficult when an employee is not suited for a particular job and then that in turn results in psychiatric symptoms, such as anxiety, depression, or aggression.

Common disability conundrums

  1. Asthma. A confident diagnosis of asthma requires both a history compatible with asthma and obstructive changes on spirometry. I have frequently seen patients who apply for disability due to treatment-refractory asthma who have had multiple spirometry tests that were all normal. These patients may have asthma but if they never have obstruction on pulmonary function testing, then their asthma is unlikely to be of sufficient severity to warrant disability retirement. Often, they have an alternative diagnosis, such as vocal cord dysfunction. Occupational asthma can be more problematic since patients may only have obstructive changes when they are actually in the workplace. In this situation, obtaining workplace spirometry is ideal. At the least, a methacholine challenge test in the pulmonary function laboratory to confirm inducible bronchospasm should be obtained.
  2. Diseases causing dyspnea. Like pain, dyspnea is a subjective symptom. However unlike pain, dyspnea has quantifiable findings with pulmonary testing. When patients claim disability due to conditions causing dyspnea, there must be objective evidence of pulmonary (or cardiac) impairment. This generally means a full set of pulmonary function tests for patients with lung disease. If the patient’s subjective dyspnea is out of proportion to the PFT findings, then a cardiopulmonary exercise test can be valuable. If the dyspnea is also significantly out of proportion to the exercise test findings, then disability retirement will generally be denied.
  3. Heart failure. Medical science has greatly improved the management of congestive heart failure over the past 25 years. With beta-blockers, ACE inhibitors, and cardiac rehab, patients can have substantial improvement in their exercise tolerance and even normalization of their left ventricular function over time. Do not rely solely on cardiac imaging tests and stress tests from many years in the past. If you are not sure of the patient’s current hemodynamic status, it is reasonable to ask that new testing be performed. However, do not rely on overly simplistic, “one-size-fits-all” ejection fraction thresholds for disability determination. For example, an ejection fraction of 40% might be disabling for longshoreman but not disabling for an accountant.
  4. Chronic pain syndromes. Pain is real but is unfortunately not objectively measurable. Moreover, major goals of comprehensive chronic pain management programs are not just to control pain (with medications, physical therapy, etc.), but also for the patient with chronic pain to be able to live as normal of a life as possible despite pain. Exercise is a major component of the management of chronic pain, particularly in conditions such as fibromyalgia. Disability retirement can often make chronic pain more difficult to manage by fostering a more sedentary lifestyle. For these reasons, conditions such as chronic migraine and fibromyalgia are rarely grounds for permanent disability unless these conditions are accompanied by objective findings on X-rays or other tests.
  5. Depression. Psychiatric conditions, such as depression, pose significant challenges for independent medical examiners. Unlike medical conditions such as heart failure and asthma, the examiner relies almost entirely on the patient’s history and the mental status exam. The degree of depression is important – major depression is generally disabling but dysthymia is generally not disabling. Also, disability applicants can sometimes overstate their symptoms in order to obtain disability – the use of inventory questionnaires that identify exaggeration, overstatement, or malingering can be valuable. Depression tends to improve with time and treatment, so re-examination for continuation of disability benefits in 1-2 years is usually advised. Sometimes, patients (or their attending physicians) will have significant improvement in dyspnea but will claim that return to the workplace will cause their depression to relapse. This is frequently more of an unfounded fear than a real threat. A compromise can be a gradual return to work with careful psychiatric follow-up during the return.
  6. Obesity. This is becoming an increasingly difficult issue for employers and disability insurance companies due to the rapid rise in obesity rates in the United States. Obesity by itself is generally not grounds for medical disability but the complications of obesity can be (arthritis, etc.).
  7. Sleep disorders. Sleep apnea and narcolepsy are very common.  In the past, these were almost always grounds for disability retirement. However, with advances in CPAP devices for sleep apnea, most workers with sleep apnea can be adequately controlled. Moreover, most current CPAP devices can be interrogated to determine patient compliance. Similarly, pharmacologic therapy has greatly improved outcomes in patients with narcolepsy. There are simply too many Americans with sleep disorders to give everyone disability retirement. In order to be impaired, there should be evidence of patient compliance with treatment and a recent polysomnography test (for sleep apnea) or multiple sleep latency test (for narcolepsy) while the patient is on maximal medical therapy in order to substantiate impairment.
  8. Cancer. In past editions of the American Medical Association’s Guides to Permanent Impairment, it was stated that patients with cancer should be considered impaired for 5 years after a cancer diagnosis. Cancer treatment has come a long, long way since then and simply having cancer does not imply that the patient is impaired from their cancer. For example, some leukemias can be cured with stem cell transplant. Chronic lymphocytic leukemia can be well-controlled with medications for years or decades. Patients with breast cancer are frequently able to be cured with surgery, radiation, and chemotherapy (even those with axillary lymph node involvement). Grounds for disability due to cancer can include disabling side effects of treatment (for example, nausea and vomiting from chemotherapy), progression of cancer despite treatment, and advanced cancer with no reasonable hope for response to treatment.
  9. Immunosuppression. Drugs used to chronically suppress the immune system are more widely used than ever before – for cancer chemotherapy, for transplant rejection prevention, and for inflammatory disease treatment. These drugs can impair the body’s ability to fight off infectious diseases. Many workers are regularly exposed to infectious diseases in their workplace: flight attendants in crowded aircraft, teachers in classrooms fully of children with colds, and healthcare workers caring for infected patients. Fortunately, most of these workplace exposures are to respiratory viruses. For viruses such as influenza and COVID, there are effective vaccines. Most of the other common respiratory viruses (such as common cold viruses) are generally not excessively risky to immunosuppressed persons. Instead, the immunosuppressed person’s greatest danger is from bacterial infections and opportunistic viruses such as CMV – these pathogens are generally not readily transmitted in a workplace. When assessing impairment from immunosuppression, the independent medical examiner should consider the risk of the specific pathogens that a disability applicant is likely to be exposed to in the workplace.
  10. COVID. In the beginning of the pandemic, some workers applied for disability if they had risk factors for severe COVID or death from COVID if they were to have a workplace exposure. This was a challenge because almost every workplace had the potential for exposure to infected people. Further, with COVID risk factors of age over 60 years old, obesity, hypertension, and diabetes, an enormous percentage of the U.S. workforce was at risk. Now, with effective vaccines that can prevent severe infection and death, there are few, if any, situations where workers with risk factors should be put on disability retirement. Nor should personal refusal to get vaccinated be grounds for disability retirement.

The importance of fair disability processes

Ultimately, disability benefits are paid by employees. Social Security disability is paid for by all of the workers who contribute to Social Security in the form of payroll taxes. Insurance companies fund disability benefits from employee disability insurance premiums. Workers compensation is funded by premiums paid by employers who then include the cost of those premiums in employee benefits. The role of the independent medical examiner is to ensure that those workers who are truly disabled have access to benefits and to protect those benefits from being used up by those who are not truly impaired.

May 16, 2022

Categories
Inpatient Practice Outpatient Practice Procedure Areas

Managing Pain In The Hospital

An important mission of the hospital is the relief of suffering and that includes relief of pain. Pain management programs are central to fulfilling this mission. The past decade has taught us that you cannot effectively manage pain with an opioid prescription alone. The combination of opioid addiction plus the COVID-19 pandemic has proven to be lethal for many Americans. Last year, there were 100,306 drug overdose deaths in the United States, up by 28.5% from the 78,056 overdose deaths in the previous year. The vast majority of these deaths were caused by natural or synthetic opioids and for many of these people, their addiction started with a pain medication initially prescribed by a doctor.

In the 1990’s, “Pain as the 5th vital sign” was the mantra of pain management services with the implication that physicians were not prescribing enough opioids and that it was our moral duty to prescribe more. The consequence of this campaign was that many of our patients became opioid-dependent. When we realized this, the pendulum swung the other way, with state medical boards restricting the amount and duration of opioid prescriptions that doctors could order. As a result, the supply of prescription opioids fell dramatically and the opioid-dependent population turned to illegal opioids. Coincident with this, inexpensive synthetic fentanyl became readily available on our streets and many Americans died of unintentional overdose due to the unpredictable concentrations of fentanyl in purchased quantities of street drugs.

The good news, is that we have a number of great alternatives to opioid pain medications for both acute and chronic pain management. However, a high-functioning hospital needs to have  more than just one of these pain management services.

What is pain, anyhow?

Pain exists when our peripheral nerves let us know that a part of the body is being injured. This is a great defense mechanism to avoid bodily harm, for example, pain is how we know to pull our hand away when we touch a hot stove. But pain can become pathologic when those pain nerves keep firing even though there is no avoidable injury – for example, the patient with bone metastases from cancer, the patient hospitalized after multiple trauma, the patient with chronic arthritis, or the patient recovering from a knee replacement surgery. In those situations, the pain nerves just keep firing away and there is nothing that the person can do by themself to make those nerves stop.

But there is a lot more to the perception of pain than just signal from a peripheral nerve. There are pain amplifiers that can turn the volume of pain up. The most important of these are fear, anxiety, and depression. Often, the presence of one of these modifiers can convert tolerable pain into intolerable pain.

What pain management services does the hospital need?

Comprehensive pain management does not boil down to having a single pain management service. Hospitals need to have a spectrum of options for treating pain in order to do the most good for the most people. All too often, the physicians or advance practice providers who are proficient with one type of pain management option are not proficient with other options.

  1. Acute pain services. These are inpatient providers, frequently anesthesiologists, nurse anesthetists, pharmacists, and/or nurse practitioners. These providers are very good at managing temporary pain, particularly post-operative pain and trauma-related pain. They will have experience in managing pain pumps and in selecting opioid and non-opioid pain medications that are meant to be used for limited numbers of hours or days. A larger hospital can afford to maintain an acute pain service but the low patient volume at a smaller hospital may make an acute pain management service cost-prohibitive. In order to serve our smaller, urban hospital, we created an acute pain telemedicine consultation service with providers located at our larger, tertiary care hospital located on the other side of town.
  2. Pain and palliative care services. These are providers who may work in either inpatient or outpatient areas and typically focus more on chronic pain management. They are usually physicians who have completed a palliative medicine fellowship who lead a team that may include nurse practitioners, physician assistants, pharmacists, and social workers. Cancer-related pain and sickle cell anemia-related pain are examples of their clinical focus. Although chronic opioid prescription may be a part of their practice, they will also typically address pain modifiers, such as fear and depression.
  3. Interventional pain services. These are physicians who have done fellowship training in interventional pain management and most commonly draw from anesthesiology, physical medicine & rehabilitation, and neurology. Their practice is generally outpatient and many include steroid injections, radiofrequency ablation, intrathecal pumps, sympathetic blocks, peripheral nerve stimulators, and spinal stimulators. They will often interface with outpatient therapies such as physical therapy, aqua therapy, and psychology. The procedures that they perform often require use of the operating room or an imaging area such as a cath lab or interventional radiology lab. Many of their procedures are done using moderate sedation but some may require general anesthesia.
  4. Sports medicine. These are family physicians, internists, or pediatricians who have done fellowship training in sports-related injuries and over-use injuries. Despite the name, sports medicine physicians treat many patients who are not athletes. They will often interface with physical therapists, athletic trainers, and orthopedic surgeons when directing specific treatments for injuries accompanied by pain.
  5. Complementary and alternative medicine. This includes a wide variety of services such as acupuncture, massage therapy, chiropractic treatments, yoga, and traditional Chinese medicine. Although physicians may be involved in alternative medicine, many of these providers are non-physicians. Many hospital medical directors take a jaded view of alternative medicine. However, these services can often de-amplify pain by reducing anxiety and fear. They can also provide a sense of control to patients with chronic pain that can make pain much more manageable. Regardless of what the hospital medical director may think, if the patient believes that these services work, then they can be beneficial.
  6. Inpatient physicians. Hospitalists, surgeons, and anesthesiologists are the first-line of pain management for most inpatients. However, the formal training that they get in pain management is highly variable. Clinical practice guidelines and treatment protocols can be very useful to ensure a hospital-wide standard of practice. Periodic continuing medical education events are also valuable. One of the most important roles of these physicians is to manage pain expectations. If patients are told that they are going to have post-operative pain before they actually have their surgery and they are told that their pain will be manageable with non-steroidal anti-inflammatory drugs and physical therapy, then those patients are less likely to require opioids post-operatively compared to patients who go into surgery unprepared to experience any pain after surgery.
  7. Outpatient physicians. Primary care physicians, surgeons, and emergency medicine physicians are the front-line of pain management for most outpatients. Once again, their formal training in pain management can be highly variable and so just as for inpatient physicians, clinical practice guidelines, treatment protocols, and periodic continuing medical education are usually necessary. Most state medical boards have state-specific rules and regulations regarding chronic opioid prescription and  it can be very difficult for the primary care physician to ensure that all of the monitoring and documentation requirements are met. A robust electronic medical record can help with this. But if there is a critical mass of patients receiving chronic opioid medications, an advanced practice provider dedicated to chronic, stable-dose opioid management can be cost-effective.

In addition to pain services that manage a spectrum of conditions, there are also disease-specific specialists needed to manage certain conditions. Migraine (often managed by neurologists) and fibromyalgia (often managed by rheumatologists) are two examples. Having a physician on the hospital medical staff who specializes in these conditions can help avoid primary care physicians ordering opioids out of frustration.

Match the patient with the pain service

Although there is frequently a lot of overlap between different types of pain services, to optimally meet the needs of the most patients, all seven of the above pain services need to be available – if not in each hospital, then at least somewhere in the community. No two patients are exactly alike when it comes to pain tolerance and pain perception. Treating fibromyalgia with chronic opioids just doesn’t work. Nor does bone metastasis pain with physical therapy. We should strive to match the patient’s type of pain with the right type of pain service.

Our natural tendency as humans is to use whatever tool we are familiar with to fix whatever problem we face (“When all you have is a hammer, everything looks like a nail”). When it comes to pain management, be sure that your hospital has a full toolbox.

February 19, 2022

Categories
Epidemiology Outpatient Practice

COVID And Travel

We are now two years into the COVID-19 pandemic and there is a lot of pent-up demand for travel. Canceled vacations are being rescheduled. Postponed weddings are being booked. Grandparents want to see grandchildren who live in distance cities. People just want to get out. But the pandemic is far from over and travel precautions are as important now as ever. So, how should we advise our patients, families, and co-workers who plan travel?

First… the obvious

There are some travel precautions that can apply to anyone. Travel advice that should be universal includes:

  • Delay traveling until you are vaccinated
  • If you are vaccinated, get a booster before traveling
  • Make sure that your traveling companions are vaccinated
  • If you or your traveling companions have COVID-related symptoms, do not travel

What should you pack?

Since the pandemic began, I’ve made several driving trips to North Carolina, Maryland, and Virginia. I flew to Bar Harbor, Maine for a week of hiking. I flew to northern California for a week at the coast. I flew to San Francisco to visit with a new grandchild for several weeks. Here is my COVID packing list:

  • Rapid COVID tests. You never know whether test kits will be available at your travel destination. You may need one because of symptoms or because it will be prudent to test prior to visiting a relative with risk factors for severe COVID.
  • Extra face masks. Face masks get stuffed into pockets, get left on kitchen counters, and fall off into the mud. The elastic ear loops on surgical masks tend to break. Always carry extras with you.
  • Hand sanitizer. A good idea for travel before COVID and an even better idea during COVID. TSA now allows passengers to carry up to 12 ounces of alcohol hand sanitizers on aircraft. Keep a bottle in your car or in your purse.
  • Clorox wipes. Did a snotty nosed kid grab the door knob to the gas station two minutes before you did? Keeping sanitizing wipes in your car or hotel room can bring piece of mind.
  • Thermometer. Jet lag and sunburn can cause symptoms that can resemble COVID. You keep a thermometer at home in case you get a febrile illness – take it with you on vacation.
  • Oximeter. OK, admittedly I’m biased by being a pulmonologist. But I’ve seen too many “happy hypoxemic” COVID patients in the hospital who had oxygen saturations in the 80’s without any shortness of breath. If you do get COVID, checking your oxygen saturation is just as important as checking your temperature (and maybe more important).
  • Acetaminophen and/or NSAID. If you do get COVID while traveling, you are going to need to isolate yourself. That means not going to the local pharmacy to buy Tylenol so carry some with you.
  • Vaccine card. Here in Ohio, the idea of requiring a vaccine card is about as socially acceptable as laws about gun restriction. However, many communities require documentation of vaccination to go into a restaurant or bar. Even when not required by local ordinances, some restaurants and venues require evidence of documentation because it brings in otherwise wary customers. Take a picture of your card and keep it on your phone.
  • Extra medications. If you take prescription medications, bring enough to get you through a quarantine period in case you or a travel companion have to extend your travel time due to a COVID infection.

Travel within the U.S.

Check the websites first! The CDC’s COVID data website can give you up to date information about the prevalence of COVID at your travel destination and about percent of the county that is vaccinated. In addition, each state’s department of health website can give you even more data. City department of health websites can tell you about local indoor masking and vaccination documentation requirements. Current COVID-related hospital occupancy data can tell you whether or not you will have available healthcare if you fall and break your leg.

Car travel. Keep hand sanitizer, Clorox wipes, and extra masks in your car. Wear masks at all times when indoors at restaurants, rest stops, and gas stations. When driving from Ohio to North Carolina, we no longer stop at restaurants – we pack a lunch and eat it in the safety of our car. If you have to go through toll roads, EZpass allows you to skip the toll both attendants.

Restaurants. Check restaurant websites to find out if they require employees and/or customers to be vaccinated – if nothing else, these restaurants attract customers who take COVID seriously and consequently are less likely to be infected. Eat at off hours – instead of eating dinner at 6:00 PM, consider eating at 4:30 or 9:30 when the building will be less crowded. Consider carry-out – In Bar Harbor, we ate all of our dinners as carry out on the balcony of our hotel room overlooking the ocean – better scenery and no worrying whether the anti-masker at the table next to you is going to cough in your direction while you are eating your sandwich. In cities like New York and San Francisco, you must show your vaccine card to enter.

Minimizing risks during air travel

The airport is often riskier than the plane. Modern aircraft have very advanced air filtration systems. Cabin HEPA filters remove 99.9% of airborne viruses and the volume of air in the cabin is exchanged every 2-3 minutes. Air enters the cabin through the ceiling and exits the cabin through floor vents in the seat rows. In addition, each passenger can adjust their own personal overhead air vent for additional comfort and air flow. So, even though passengers are seated close together, the airflow systems provide a lot more safety than in a building, such as the airport. Furthermore, people tend to be less attentive to masking and social distancing in the terminals than once they get on the plane

In the airport: Avoid traveling on busy travel days – Tuesdays and Wednesdays tend to be the least busy. Use hand sanitizer liberally – as noted above, TSA currently allows you to carry 12 ounces of alcohol hand sanitizer, rather than the 3 ounce limit on other liquids. Maintain social distancing whenever possible – TSA precheck lines are generally less congested than the regular TSA lines; if you have layover, find the least busy gate to sit and wait until your aircraft boarding time. Avoid airport restaurants and bars – eat a meal before you leave home.

In the plane: Turn on your overhead air vent to increase the filtered air that you are breathing. Avoid or minimize eating and drinking during the flight – when the flight attendants pass out beverages and snacks, everyone tends to take their masks off to eat/drink at the same time so wait to eat or drink until after everyone else has finished and re-masked. When eating or drinking on the plane, try not to take your mask off for any longer than you can hold your breath. Wear a mask at all times – the greater the filtration of the mask the better; I am fortunate that I was fit-tested for an N-95 mask (with a beard) and that is the mask I wear.

Travel outside of the U.S.

Check the websites first! COVID travel restrictions are constantly changing and each country is very different. Some countries are not currently permitting non-essential travelers to enter. Check the government websites of any country you plan to visit to find out their specific travel requirements. Next, check the U.S. state department website for travel safety information about the country you will be traveling to. Finally, check the CDC website that stratifies the COVID risk of each country. Don’t go to countries that are classified as level 4 risks and if you can, select from those that are level 1 risks.

You may need COVID travel insurance. Although many commercial health insurance policies will provide at least some coverage for illness-related expenses abroad, most do not cover the cost of medical evacuation or quarantine housing. Many countries now require documentation of a COVID-specific travel insurance policy. These can be purchased on-line and typically run about $500 per person, depending on one’s age and duration of travel.

COVID testing prior to arrival. Most countries currently require travelers to have a negative COVID test prior to entry. Some require a PCR test while others will accept a rapid COVID test. Some require the test to be done within 24 hours prior to arrival, others require it within 48 hours, and others require testing to be done in the immigration area of the airport at the time of arrival. In all cases, some form of documentation of the test is required. For this reason, the self-read home test kits sold at your local pharmacy will not be sufficient. Many pharmacies and U.S. airports will do travel COVID testing with advance scheduling. If the country that you will be traveling to requires testing to be done in their immigration area, they will likely require payment in cash at the time of testing.

Will you need a COVID certificate? Some countries (for example, member of the European Union) require you to have a COVID certificate in order to go just about anywhere in that country. These can be obtained on-line from the each government’s website.

Returning to the U.S.

Check the websites first! The CDC travel website provides up to date information about entry requirements to get into the U.S., including requirement for U.S. citizens returning from travel abroad. These requirements can change so check this website when first planning a trip and again shortly before departing.

You will need a COVID test. The U.S. requires documentation of a negative COVID test (rapid or PCR) within 1 day prior to arrival. This is slightly different than the 24 or 48-hour requirement of most other countries. The test can be done anytime the day before arrival in the U.S. Many hotels and airports in other countries will perform testing and provide documentation for a fee. You can also do an at-home test that has telehealth proctoring. Importantly, most of the commercial test kits sold at pharmacies are self-read and do not have a telehealth component. Because you have to present documentation of a negative COVID test to get into the U.S., these self-read tests will not suffice. Examples of acceptable at-home tests include:

  • Abbott BinaxNOW
  • Ellume-AZOVA
  • Cue
  • Quered

Note that there are two versions of the Abbott BinaxNOW test – one that is sold at retail pharmacies and does not have a telehealth component and a second version that is sold on-line that does have a telehealth component. Only the second version is accepted for entry into the U.S. can can be ordered online at emed or optum. It is a good idea to pack at least one of these tests for each traveler, even if you plan to get your pre-U.S. entry COVID test at a hotel or airport at your travel destination – you just can predict if the hotel will run out of tests or if the airport has staffing issues on the day that you plan to fly back to the U.S.

Weighing the risks of travel

Patients would often ask me “Is it OK for me to travel?” Sometimes, the answer was a flat-out ‘no’ but more often, it was varying degrees of ‘maybe’. There are two considerations: the traveler’s personal risk factors and the risks associated with the travel destination. The good news is that people who have been vaccinated and boosted are at relatively low risk of getting so sick that they require hospitalization or die if they do get COVID while traveling. However, risk factors for severe infection such as advanced age, obesity, diabetes, hypertension, or immunosuppression must be factored in, even for those who are fully vaccinated. The travel destination is at least, if not more important. Locations where there is a culture of masking and vaccination are lower risk than areas dominated by anti-maskers and anti-vaxxers. Destinations where you won’t encounter crowds and where you will mostly be outdoors are lower risk than destinations where there will be crowded indoor areas. A vacation rental home where you will be eating your own meals is less risky than a hotel. Cruises are probably among the highest risk travel options.

Just being a human poses some degree of risk in this COVID pandemic. Traveling incurs some additional risk but the good news is that most people can minimize that risk by careful planning and taking the right precautions.

January 5, 2022

Categories
Outpatient Practice

Should Doctors Apply To The Interstate Medical Licensure Compact?

Ohio has become the 35th state to join the Interstate Medical Licensure Compact. The Compact permits a physician in one state to easily obtain an expedited medical license in a different state. So, should you apply to the Compact?

What is the Interstate Medical Licensure Compact?

Each state has a state medical board that issues medical licenses but those licenses only allow a physician to practice medicine in that specific state. If a physician wants to practice in more than one state, then that physician must obtain a separate medical license from each of those states. In the past, only a minority of physicians held active licenses in two or more states – mainly physicians who live close to state borders with practice locations on both sides of the border, physicians who recently relocated to a different state, and locum tenens physicians who travel throughout multiple states doing short-term temporary jobs. Telemedicine has created a new need for physicians to hold medical licenses in multiple states.

The emergence of telemedicine in the 1990’s was accelerated in the early 2000’s by the use of electronic medical records. When telemedicine occurs across state lines, medical care is defined as occurring in the state that a patient is in, not the state that the physician is in. Therefore, physicians who practice telemedicine must have a separate medical license for each state that their patients reside in. The requirements for licensure differ from state to state with each state requiring separate applications, background checks, verification of training, and professional references. This process was often expensive and took several months. In 2014, a group of leaders from several state medical boards got together to develop a streamlined process for obtaining a medical license in more than one state and in 2017, the Interstate Medical Licensure Compact became operational.

In the past 4 years, more and more states have joined the Compact. Currently, 36 states are either active in the Compact or have legislation introduced to join the Compact. There are 14 states that are not members of the Compact and have not initiated the process of joining the Compact. These include all of the states shaded in gray below, most notably: New York, Florida, and California.

The Compact is administered by the Interstate Medical Licensure Commission. The Commission in turn is composed of 2 commissioners from the state medical boards of each participating state. As of June 2021, the Compact had processed 14,037 applications and had issued 20,976 medical licenses.

There is an analogous organization for nurses called the Nursing Licensure Compact that was originally developed in 2000, much earlier than the Interstate Medical Licensure Compact. The nursing compact has 38 currently active participating states with pending legislation in 8 more states.

Who is eligible to apply?

The first requirement is that a physician designate a State of Principal License, or SPL. A physician’s SPL must meet at least one of the following requirements:

  1. The physician’s primary residence is in the SPL
  2. At least 25% of the physician’s medical practice occurs in the SPL
  3. The physician is employed to practice medicine by a person, business or organization located in the SPL
  4. The physician uses the SPL as his or her state of residence for U.S. Federal Income Tax purposes

In addition to designating an SPL, there are other requirements for a physician to participate in the Compact. The physician must meet all of the following:

  1. Have graduated from an accredited medical school, or a school listed in the International Medical Education Directory
  2. Have successfully completed ACGME- or AOA-accredited graduate medical education
  3. Passed each component of the USMLE, COMLEX-USA, or equivalent in no more than three attempts for each component
  4. Hold a current specialty certification or time-unlimited certification by an ABMS or AOABOS board

Lastly, there are several exclusions to participating in the Compact. The physician cannot have any of the following:

  1. Any history of disciplinary actions toward their medical license
  2. Any criminal history
  3. Any history of controlled substance actions toward their medical license
  4. Currently be under investigation

Physicians who meet all of these criteria are eligible to apply to participate in the Compact. It is estimated that about 80% of U.S. physicians in participating SPL states are eligible.

What is the application process?

Physicians meeting the eligibility criteria apply to the Compact by paying a $700 application fee and getting a criminal background check (including fingerprints) from their State of Principal Licensure. The application is done on-line at the Compact’s website.

When the physician’s application is approved by the Compact, a Letter of Qualification is issued to that physician. The Letter of Qualification permits the physician to apply for medical licenses in any of the states participating in the Compact and it is good for 1 year. If the physician decides to apply for medical licenses in additional states later during the 1-year period that the Letter of Qualification is valid for, then there is an additional $100 administrative for each additional state the physician applies to. After the 1-year period is over, the physician must re-apply for a new Letter of Qualification if that physician wants to obtain medical licenses in additional states. When it comes time to renew medical licenses in those states that the physician originally obtained a license through the Compact, the renewals are done on-line on the Compact’s website.

In addition to the $700 Compact fee, there is also a fee charged by each state for a medical license. The fees vary from state to state and range from a low of $75 (Alabama) to a high of $790 (Maryland) with most states running around $300-$500. The fees for each state can be found by clicking here.

The average number of licenses that each physician obtains through the Compact is three. The average amount of time it takes to get each license is 19 days with 51% of licenses available within a week.

Should I apply?

If a physician only intends to practice in the state that he/she resides in, then there is no need to apply to the Compact. However, there are 5 groups of physicians who can benefit from obtaining additional state medical licenses through the Compact.

Locus tenens. Physicians who practice at hospitals or medical practices for short-term employment can more easily obtain licenses for the various states that they anticipate working in.

Physicians practicing close to state borders. Many physicians located near state borders may need hospital privileges at hospitals on both sides of the border or may have office practices on both sides of the border.

Physicians seeking new jobs. The standard application process to get a medical license can take a long time – for most states it takes about 3 months but in some states it can take up to 9 months. This can be a problem for residency and fellowship graduates obtaining their first job out of training if it is in a different state than their training program is located. This is also a problem for physicians who are changing jobs to a new practice in a different state. By expediting the licensure process, the Compact can greatly reduce the time required to get a license in a new state.

Medical volunteerism. Physicians often donate their time for providing free care to the underserved. By facilitating licensure, physicians will now be able to more easily provide that care to underserved populations in other states.

Telemedicine. This is perhaps the area of medicine that benefits the most from the Compact. Since telemedicine occurs in the state that the patient is located in, if a physician does not have a license in that particular state, then the physician cannot legally practice medicine via telemedicine with that patient. This was a particular problem for me in my subspecialty interstitial lung disease practice since many of my patients lived in West Virginia, Kentucky, Indiana and other states. Also, many of my patients would winter-over in southern states. If these patients had a medial issue arise while out of Ohio or if they just needed a regularly scheduled visit, they had to travel to within Ohio’s borders for me to legally do a telemedicine visit. During the early part of the COVID pandemic, I did most of my outpatient practice via telemedicine. However, many of my patients living in West Virginia had to either drive to Columbus for an in-person visit or forgo their regular visits since I did not have a West Virginia medical license and could not legally do telemedicine with them in their homes. During COVID, many states waived the telemedicine requirements so that out-of-state patients could legally have telemedicine visits with their doctors (but Ohio was not one of them). Even something as simple as prescribing an antibiotic for a patient with bronchitis or a course of steroids for a patient with an asthma flare is legally risky if that patient calls the office from another state. The Compact permits physicians to practice telemedicine in most states that their patients are located in without requiring those patients to travel the often long distances to get to the physician’s office for an in-person visit.

Don’t forget about malpractice insurance

Just because a physician has a license to practice in a specific state does not mean that their medical malpractice insurance will cover them in that state. This can be a particular problem with telemedicine – there is no guarantee that their policy covers telemedicine when the patient is out of state. Medical malpractice premiums vary considerably from one state to another, depending on a number of factors. Some states have passed malpractice reform legislation that has sharply reduced malpractice lawsuits in those states. In some states, there are limits to the monetary amount of malpractice claims. In other states there is a culture of litigiousness. All of these factors affect the cost of malpractice insurance. As an example, the average internal medicine physician’s malpractice premium is $3,261 in Wisconsin and $15,436 in Florida.

Before obtaining additional state medical licenses for telemedicine purposes, physicians should check with their medical malpractice insurance company to find out if they will be covered to do telemedicine in those states. Many physicians will be required to purchase additional multi-state liability coverage. Large medical centers that are self-insured may not permit their physicians to practice telemedicine in other states, particularly those states that are considered high-risk for malpractice lawsuits.

The future of the Compact

Ideally, all states would join the Interstate Medical Licensure Compact. However, there is a greater need for certain states/territories to participate in the Compact. Alaska, Hawaii, Puerto Rico, and the Virgin Islands could all benefit from participation because of their remoteness – by expediting medical licenses from out-of-state physicians, their citizens would have greater access to specialized care via telemedicine. As an example, there are no lung transplant centers in these states and territories. There is also a greater need for Florida to participate in the Compact given the number of people in the East Coast and Midwest who spend winters in Florida. By facilitating medical licensure for these winter resident’s out of state physicians, better continuity of care can be delivered.

Because participation in the Compact requires endorsement by each individual state’s medical board and requires approval by the legislature of each state, action to get all of the remaining states and territories must start from grass root efforts within each of these states and territories. The medical communities of some of these states could feel threatened by more out-of-state physicians providing medical care by telemedicine that would otherwise have been provided by physicians located in those states. However, the overall cost of medical care could be reduced by facilitating out-of-state telemedicine – it is far less expensive for a patient vacationing in Florida who develops a poison ivy rash to have a telemedicine visit with their primary care physician back in Michigan than to go to an emergency department in Florida.

The medical malpractice insurance barrier must also be addressed. Insurance companies can make it simpler to obtain policies that include multi-state telemedicine coverage. Large medical centers that are self-insured should also make multi-state telemedicine malpractice coverage more easy to obtain – it is in their best interest to enhance telemedicine professional revenue and also to attract more out-of-state patients to telemedicine care who would not otherwise have traveled to their state for in-person medical care.

The group that has perhaps the greatest potential benefit from the Compact are academic medical centers. Most are self-insured and can control the malpractice barrier to out-of-state telemedicine practice. By expanding their telemedicine reach to other states, physicians in academic medical centers can specialize in very specific diseases. For example, there may not be enough Ohioans with Birt-Hogg-Dube syndrome to support a practice specializing in Birt-Hogg-Dube but by marketing a telemedicine practice throughout a multi-state area, an enterprising academic physician could create a specialty clinic to optimize care to large numbers of patients with this rare disease and to develop research protocols for their evaluation and treatment. This is a golden opportunity for academic program development and for promotion & tenure pathways.

Physicians employed by the Veteran’s Administration and by the U.S. military can practice anywhere in the country as long as they are licensed in any one state. It is unlikely that a similar model will be adopted for non-governmental civilian medical licensure in the foreseeable future. However, the Compact is the next best option and our medical communities need to take the initiative to secure participation by all 50 states and all U.S. territories.

December 9, 2021

Categories
Outpatient Practice

COVID And Disability Determination

Physicians are being asked to fill out disability forms by patients for two COVID indications: (1) patients who have sustained permanent injury from a COVID-19 infection and (2) patients with risk factors who are fearful that they could have severe infection or death if they acquire COVID-19 in their workplace. So what should you do when presented with one of these forms?

Understanding the disability process

The definition of disability and the requirements to get disability vary depending on whether the disability benefits are coming from Social Security, Worker’s Compensation, or a disability policy from a commercial insurance company. In general, permanent disability is when there is a medical condition that prevents a person from performing their job and is expected to be present for > 12 months. In some cases, a nurse practitioner or physician assistant can fill out disability application forms for a patient but most of the time, the disability-granting organization will require the forms to be filled out by a physician.

Disability-granting organizations recognize that there is often an inherent conflict of interest when a patient’s personal physician fills out a disability application. First, that physician generally feels a responsibility to be the patient’s advocate and usually wants to be nice to their patient. Second, the patient is paying their physician for their office visits and their time to fill out the forms. And third, the physician often does not want to risk losing a patient by refusing to fill out the disability application. For these reasons, the disability insurance company will usually require an “independent medical examination” by a physician experienced with the patient’s particular medical condition. The physician is one that does not have an existing doctor-patient relationship with the disability applicant and is paid by the insurance company for their unbiased opinion in order to eliminate financial conflict of interest. The insurance company or other disability-granting organization will then have a staff member or committee knowledgeable in disability determine whether the applicant warrants disability benefits based on the independent medical examiner’s findings. In some situations, the disability process may involve a hearing with a judge or magistrate. The goal of this process is to get disability benefits to those persons who are truly disabled and avoid paying benefits to those persons who are not truly impaired.

Although there is a lot of variation between different disability-granting organizations, the common requirements to be granted disability include:

  1. The medical condition must either be new since the applicant began employment or if it is a pre-existing condition, it must have worsened since the date of initial employment.
  2. The medical condition must have a diagnosis (or tentative diagnosis). A symptom alone, such as shortness of breath, is generally not grounds for disability unless there is a diagnosis to go along with it (such as COPD).
  3. The medical condition must be of sufficient severity to prevent the applicant from doing their regular employment duties. Here, the applicant’s specific job requirements have to be taken into consideration – for example, knee arthritis that impairs walking has a different disability implication for someone who hangs drywall for a living than it does for a medical transcriptionist.
  4. The medical condition is expected to be “permanent” which generally means lasting at least 12 months.
  5. There must be objective evidence that the condition causes impairment. For this reason, it is very difficult for patients with chronic pain syndromes (migraine headache, fibromyalgia, etc.) to get disability without collaborating x-ray, EMG, or physical examination abnormalities. Similarly, applicants with conditions such as chronic fatigue syndrome that lack abnormalities on diagnostic tests are often denied disability.

Patients seeking disability after COVID infection

Shortness of breath and fatigue attendant to COVID-19 infection can last for weeks or even months. However, these symptoms will ultimately improve in most patients with mild to moderate COVID-induced heart or lung disease. For this reason, it is prudent to initially recommend temporary disability, rather than permanent disability. Even the sommelier who loses his/her sense of taste and smell due to COVID will usually have those senses return within a year.

Post-COVD lung disease

Patients seeking disability for post-COVID dyspnea need to have objective testing showing impairment. Although x-rays can be supportive, testing usually requires pulmonary function tests. Many disability-granting organizations will use the American Medical Association’s Guides to Permanent Impairment as a resource. This guide divides pulmonary impairment into five categories from 0 (no impairment) to 4 (45-65% impairment of the whole person).

COVID-19 usually causes pulmonary impairment by post-inflammatory pulmonary fibrosis which can be identified on a high resolution chest CT scan and often on simply a plain chest x-ray. Post-inflammatory pulmonary fibrosis will cause a reduction in the FVC and DLCO. Patients with obstructive lung disease (COPD or asthma) will have a reduction in the FEV1 with a normal (or slightly reduced) FVC – obstructive lung disease is considerably less common following COVID-19 but can occur occasionally. The table above should be used as a guide but must be interpreted in the context of the patient’s job requirements. For example, a laborer might be unable to perform regular job duties with PFTs in the class 2 range whereas someone with a desk job might not be impaired until they reach class 4. Also, a furnace repairman with class 1 PFTs who requires home oxygen might be unable to work if he/she cannot wear oxygen around open flames of a gas furnace. Patients with the worst post-inflammatory pulmonary fibrosis will be on chronic home ventilators – these patients cannot do pulmonary function tests and anyone with fibrosis that bad does not need additional testing to warrant permanent disability.

The cardiopulmonary exercise test is one of the most under-used tests when it comes to disability. For a guide to interpreting this test, see my previous blog post. This test allows the physician to determine if a patient’s shortness of breath is due to lung disease, heart disease, or deconditioning. To determine if a patient is objectively impaired, the key value is the maximum oxygen uptake, or mVO2. This test can be particularly helpful if the patient has shortness of breath out of proportion to the findings on the regular pulmonary function tests.

Post-COVD heart disease

COVID-19 can also cause myocarditis and can lead to impairment from heart failure. Myocarditis will often show up best with a cardiac MRI but just having radiographic evidence of myocarditis does not necessarily mean that the patient is impaired from myocarditis. For this, you need some evidence that the function of the heart has been affected. Most commonly, this will be a measurement of the ejection fraction. Although the ejection fraction can be measured by cardiac MRI, it is cheaper and easier to obtain by a cardiac echo. If the patient’s symptoms are out of proportion to the abnormalities on the cardiac echo, then once again, the cardiopulmonary exercise test can be valuable to determine impairment.

Post-COVD chronic fatigue

The generalized fatigue after a COVID-19 infection can last for a long time. In many ways, these patients resemble those with chronic fatigue syndrome. In addition to excluding heart disease or lung disease as a cause of the fatigue, these patients generally need a fairly extensive metabolic work up to exclude anemia, thyroid disease, kidney disease, liver disease, or electrolyte imbalance. In addition, sleep apnea is often a consideration. Most of the patients with severe COVID-19 infection had some co-morbid disease to begin with, such as diabetes, heart failure, or obesity which can also contribute to fatigue. Although post-COVID fatigue may warrant temporary disability while the patient recovers from the COVID infection, patients will find it very difficult to get permanent disability unless there is some objective test abnormality to attribute the fatigue to. Patients with fatigue will often benefit by physical therapy initially and then an exercise program later.

Patients seeking disability to avoid COVID infection

In the summer and fall of 2020, I had a number of patients who went on temporary disability because they had workplace exposure to COVID-19 and had underlying conditions that put them at risk of severe infection or death. These were often elderly or immunocompromised persons who worked in places like hospitals, schools, or restaurants. However, since the availability of COVID vaccines, the risk of severe COVID infection has markedly lessened. Furthermore, from a pragmatic standpoint, there is simply not enough money to put everyone with a COVID-19 risk factor on disability simply because they might get infected in the workplace. The three main risk factors are obesity, diabetes, and age – 42% of Americans are obese, 10.5% of Americans have diabetes, and 22% of Americans are over age 60. Some of these people have argued that they do not want to get a COVID vaccine and therefore they are still at risk in the workplace – my opinion is that they may have the right to decline a vaccine but that does not give them the right to then claim disability to avoid a vaccine-preventable condition. The one possible exception to this is patients with common variable immune deficiency. These are people who cannot make antibodies on their own and consequently, vaccines just do not work. Many of them take IgG replacement therapy and some IgG replacement products have been shown to contain anti-COVID antibodies but it is prudent to check with the manufacturer to confirm that the patient is getting a product containing anti-COVID antibodies.

Some patients seek disability because they have a condition that prevents them from wearing a mask. There are now enough other options, such as plastic face shields or PAPRs, that inability to wear a face mask is no longer grounds for disability in the vast majority of work environments.

The bottom line is that the desire to avoid workplace exposure to COVID-19 is no longer grounds for disability except in exceedingly rare situations

Disability is mostly avoidable

If a person is fully vaccinated, then the chance of that person getting a severe enough COVID-19 infection to result in permanent disability is very, very low. The risk will be even lower for those persons who have received a booster vaccine. Most Americans who are hospitalized with severe COVID infection and who get post-inflammatory pulmonary fibrosis or myocarditis are unvaccinated.

The best way to prevent disability from COVID-19 is to get vaccinated. We don’t need more tombstone epithets reading “I should have gotten a vaccine

November 16, 2021

Categories
Outpatient Practice Procedure Areas

Designing A Pulmonary Function Laboratory

Clinical laboratories are certified by CMS using the Clinical Laboratory Improvement Amendments (CLIA). Radiology departments are accredited by certification by the American College of Radiology. There are no certification or accreditation standards for pulmonary function laboratories currently so it falls to each hospital to design its own PFT lab. After being involved in the design of 4 PFT labs over the years, these are a few of the things about lab design that I have learned.

First decide what tests will be performed

The tests that the laboratory will perform will dictate the number of rooms and space required for the lab. The initial design of a pulmonary function lab should specify which types of tests will be performed in each room in order to ensure that each room is large enough for all of the equipment and supplies required for those tests.

 

The most common tests performed in a pulmonary function laboratory are spirometry, lung volumes, and diffusing capacity. These can all be done using an enclosed plethysmograph device that the patient sits inside of, sometimes called a “body box”. Each plethysmograph should be in a separate room. A small hospital or an outpatient physician group practice may only need 1 plethysmograph but most pulmonary function labs will need 2 to 4 plethysmographs, requiring 2 to 4 separate rooms. Spirometry can also be ordered as spirometry pre- and post-bronchodilator. The bronchodilator study does not require special space but usually does require a “Terminal Distributor of Dangerous Drugs License” from the state pharmacy board.

The next most common test is the 6-minute walk test. This is generally performed in a long, straight hallway with distances marked on the floor. The patient walks as fast as comfortable and the number of laps walked in 6 minutes are calculated along with the oxygen saturation during the test. The hallway should be wide enough to accommodate an oxygen tank on wheels and should should be lightly trafficked so that it can be blocked off during the duration the test. A related test is the oxygen titration study. In this test, a patient walks until their oxygen saturation drops below 89% and then supplemental oxygen is applied in increasing flow rates to determine the proper flow rate for that patient’s oxygen prescription. The oxygen titration study can be performed in the same hallway as the 6-minute walk test or can be performed on a treadmill.

The methacholine challenge test is a broncho-provocation test done by having the patient inhale increasing concentrations of methacholine, with spirometry performed after each concentration. In the past, an on-site pharmacy was generally required to perform dilutions of methacholine; however, pre-filled, pre-diluted testing kits are now commercially available, thus obviating the need for an on-site pharmacy. This test can be done in the same room used for one of the plethysmograph boxes. A related test is the eucapnic voluntary hyperventilation test that is used to diagnose exercise-induced bronchospasm.

The cardio-pulmonary exercise test is performed by having a patient ride a stationary bicycle (or sometimes by using a treadmill) while breathing into a metatabolic cart in order to measure values such as minute ventilation and oxygen uptake. This test is generally performed in separate room dedicated to exercise testing but can be performed in a room normally used for plethysmograph testing if the room is large enough to accommodate both the plethysmograph box and the exercise test equipment.

The high-altitude hypoxia simulation test is performed by measuring the patient’s oxygen saturation while breathing a 15% oxygen/85% nitrogen gas mixture from a large medical gas cylinder via a face mask. This test is used to determine if a patient requires supplemental oxygen when flying in a commercial aircraft. Because the only equipment required is the medical gas cylinder, this test can be performed in a room used for plethysmographic testing. However, it is preferable to perform this test in a room with a treadmill (or a stationary bicycle) so that the high-altitude hypoxia simulation test can be combined with an oxygen-titration test as a high altitude hypoxia exercise test in order to determine the oxygen flow rate required when a patient is walking at a high-altitude travel destination (such as Denver).

Arterial blood gases are performed by inserting a needle into the radial artery to withdraw arterial blood. This test is most commonly performed to get direct measurement of the amount of oxygen and carbon dioxide in the blood. Arterial blood gases can also be performed while the patient breaths 100% oxygen in the physiologic shunt study.

Get infection control involved early

Patients who get pulmonary function tests are vulnerable to contagious diseases due to their underlying respiratory compromise as well as due to frequenting taking immunosuppressive medications. In addition, these patients often have respiratory infections that can be transmitted to others. Your infection control department input is crucial to ensure that patients and staff are not at risk of acquiring infections from exposures in the lab.

One of the most important aspects of infection control of respiratory pathogens is the number of air changes in each room per hour. The more air changes per hour (ACH), the faster respiratory pathogens such as tuberculosis or the coronavirus causing COVID-19 are cleared from the breathable air.


The Centers for Disease Control has recommendations for the minimum ACH for each type of hospital room. This can range from a high of 15 ACH for an operating room to 2 ACH for certain storage rooms. An exam room or a hospital inpatient room is recommended to have 6 ACH and a bronchoscopy room is recommended to have 12 ACH. The CDC does not specify the ACH for a pulmonary function laboratory. However, the Veteran’s Administration recommends at least 8 ACH for a room used for plethysmographic testing and at least 10 ACH for a room used for cardiopulmonary exercise testing. In the era of COVID-19, the higher the ACH, the better. If the pulmonary function lab will also do sputum induction for suspected tuberculosis, then a negative airflow room is necessary.

In the past, pulmonary function testing utilized non-disposable mouthpieces, nose clips, and other equipment that required cleaning. This resulted in the requirement to have both a clean and a dirty utility room in the pulmonary function lab. Now, most labs use disposable mouthpieces, nose clips, and supplies so that there is no longer a need for a dirty utility room to avoid clean/dirty equipment conflicts.

The infection control department can also be helpful in room design. For example, selecting anti-microbial materials (such as copper) for door handles and other fixtures. Flooring should be made out of resilient tile with minimal seams. There should be hand washing sinks and wall-mounted hand sanitizer in each room used for diagnostic testing.

Efficiency and flexibility

Patients coming in for pulmonary function testing are often in wheelchairs and are often using supplemental oxygen. Doors to testing rooms need to be wide enough to accommodate the width of a bariatric wheelchair (48 inches). Similarly, diagnostic rooms need to contain bariatric-sized chairs. Because of the impaired mobility of many pulmonary patients, the lab should be located as close to building entrances and elevators as possible.

To optimize staff efficiency, a shared patient registration area that can serve multiple outpatient services is preferred for all but the largest pulmonary function labs. Shared waiting areas can optimize efficient use of building space; however, waiting areas should be designed so that staff can maintain line of sight observation of patients. Similarly, when possible, share resources for linen storage, housekeeping, general storage, waste storage, and staff support areas.

Most pulmonary function labs will require hemoglobin testing as part of the diffusing capacity test. Also, most pulmonary function labs will perform arterial blood gas testing. If these specimens must go to a central clinical chemistry lab, then the PFT lab should be close to that lab (at least within the same building). Most PFTs labs find it easier to perform point-of-care testing for arterial blood gases and finger-stick hemoglobin, however. Regardless of where these tests are run, sharps containers are needed in all diagnostic rooms.

Human needs

In addition to a close-by, adequately-sized waiting area, there needs to be restrooms and a staff break room near the lab (you don’t want your staff eating in the diagnostic area). The interior design should convey the appearance of a healthcare setting. There must be adequate lighting in all rooms and hallways. Be sure to have televisions in waiting areas and wifi access in all public areas. Artwork should be chosen carefully – for example, if there is a sizable Afghanistan war veteran patient population, avoid pictures of desert mountains. Similarly, pictures of happy people doing recreational activities can be depressing to patients confined to wheelchairs or oxygen tanks. Attention to privacy in door and window location can ensure that patients undergoing diagnostic testing cannot be easily seen from the hallway.

If there are exterior windows in the area of the building, it is preferable to locate rooms used for diagnostic testing where there are windows and then use windowless interior rooms for support purposes, break rooms, restrooms, staff offices, etc. Some patients get claustrophobic when enclosed in a plethysmographic box and having an exterior window in the room can lessen that claustrophobia. The plethysmograph box should be positioned so that the patient can see out the window when sitting in the box.

Room acoustics are frequently overlooked when designing the PFT lab. If you have ever stood outside of a room where spirometry is being performed, then you have inevitably heard a PFT technician shouting “Blow, blow, blow, as hard as you can…“. Performing PFTs is a loud process. Include acoustic ceiling tiles and adequately insulated walls in the initial design.

Physical layout

Rooms used for plethysmographic testing should ideally be at least 12 ft x 10 ft in size in order to accommodate the plethysmograph box, a workstation for the PFT technician, a chair, sink, equipment storage, trash can, sharps container, etc. Most plethysmographic boxes are about 7 feet tall so the ceiling height also needs to be considered. For hallway throughput safety, doors should open into the room rather than into the hallway. Data entry keyboards used by the staff should either be on mobile workstations-on-wheels or should be on swing-mounts on a wall but positioned so that the technician is facing the plethysmograph box and so that an opened door does not block the ability of the staff to see the patient in the plethysmograph box. Most plethysmograph boxes are 36 to 42 inches in diameter so having a 48 inch doorway is preferred to be sure you can get the box into the room.

Rooms used for exercise testing generally should be to be at least 12 ft x 20 ft in order to accommodate a treadmill and metabolic cart.

The hallway used for 6-minute walk testing should be adjacent to the diagnostic area. Wall-mounted medical gas outlets in the diagnostic rooms are convenient to support the needs of patients requiring supplemental oxygen but most labs can get by with re-fillable oxygen cylinders. Even if medical gas outlets are available in the diagnostic rooms, portable oxygen cylinders will still be required for tests such as oxygen titration studies; therefore a room dedicated to oxygen cylinder storage is required. Staff charting areas should ideally be in a location where staff can maintain visual observation of patients.

One of the most common mistakes in lab design is failing to plan for future growth. Most PFT labs have seen a steady increase in testing volume over the past 20 years. It is far easier (and less expensive) to expand an existing lab than to either build an entirely new larger lab or build a second satellite lab when the demand for services increases. Having adjacent space that can be readily re-purposed is wise. For example, staff offices adjacent to the lab can be relatively easily moved to a different location in the hospital or clinic building so that those offices can be converted into PFT lab expansion space in the future.

Patients who come in for pulmonary function testing are also frequently coming in to see their pulmonologist or coming in to do pulmonary rehabilitation. The best PFT labs are co-located with pulmonary physician offices and pulmonary rehab areas. Having a “one-stop-shop” for pulmonary patients can improve patient satisfaction and can give the clinic or hospital a competitive edge. Having close proximity to a physician or advance practice provider is also useful in the inevitable situations when patients develop medical conditions during pulmonary function testing or exercise testing.

Planning is key

Most people have a hard time conceptualizing what an architectural plan will look like in real-life. It is a good idea to find a large, open area and tape out the dimensions of the planned rooms on the floor. Then add taped out placements for all of the equipment and furniture as well as the door swing area. Then get input from the PFT technicians, an interior designer, the pulmonologist, and the infection control staff. It is far less expensive to get everything right the first time.

August 15, 2021

Categories
Outpatient Practice

Should Your Medical Practice Require Employee Vaccinations?

It is now mid-summer 2021 and the United States is in yet another surge of COVID-19 infections. Vaccines are now widely available and no longer in short supply. So, should you require your outpatient medical office employees to get a vaccine? First, full disclosure, my very strong personal opinion is, yes. However, there can be mitigating circumstances that can affect the decision about vaccine mandates in certain office practices.

Know your state laws

Tragically, the COVID-19 pandemic has become polarizingly politicized. As a consequence, several conservative states have passed laws prohibiting employee vaccine mandates. A recent report from Becker’s Hospital Review outlined laws affecting vaccine mandates in 11 states including: Arizona, Arkansas, Michigan, Montana, New Hampshire, North Dakota, Ohio, Tennessee, Texas, and Utah. Each state’s law is a little different. For example, Arizona has a provision exempting healthcare institutions; Ohio’s law only applies to public schools and universities and then only applies to vaccines that have not yet received final FDA approval.  It is likely that many of these state laws will be challenged in court – for example, here in Ohio, Cleveland State University (a public university) has made a requirement that students be vaccinated, despite the recent Ohio law, thus opening the door for someone to legally contest the university’s policy. However, most small medical practices do not have the time or financial resources to be the test case in their state’s court system contesting vaccine mandate restriction laws. If your practice is in one of these states, then familiarize yourself with the laws affecting your practice.

How vulnerable is your patient population?

A rheumatology or oncology practice that manages a lot of older, immunosuppressed patients is different than a sports medicine practice that primarily manages otherwise healthy, younger patients. Patients who are more likely to become sicker or die should they become infected with COVID-19 need greater protection from unvaccinated office employees. If your practice has a significant number of patients who are over age 60, immunosuppressed, obese, or diabetic, then office employee vaccine mandates become more important.

Is telemedicine an option?

Patients of medical practices are customers of your medical business and customers across the country are increasingly demanding that the businesses that they go to be safe with respect to COVID-19. If your patients perceive that your office is not a safe place, they will not walk in the door. So, if you are not able to vaccinate all of your office staff, look to how you can use telemedicine to cater to those patients who are not comfortable being in a room with unvaccinated staff. Many medical services can be performed just as well by telemedicine as by an in-person office visit, for example, those that are primarily for counseling or data review. Other medical services that require a hands-on physical examination or office-based procedure may not be amenable to telemedicine.

Can you afford to fire an unvaccinated employee?

In a large medical practice with many employees, if one employee refuses to get a mandated COVID-19 vaccine, then it is not a terrible loss to the practice to fire that employee – he or she is dispensable. However, a solo practitioner with a single office nurse who has worked with that practitioner for many years may not be able to fire that nurse for refusing to get vaccinated – the practice’s operations would suffer too much and would likely lose money while recruiting and orienting a new nurse.

You don’t need a mandate if everyone is already vaccinated

By far, the easiest solution is for all of your employees to be vaccinated voluntarily. Everyone who has ever trained a pet dog or a toddler knows that rewarding good behavior is more effective than punishing bad behavior. Mandates can be perceived by some employees as a form of punishment. You are better off listening to your unvaccinated employee’s concerns about the vaccine and then use education and patience to alleviate those concerns. Firing an unvaccinated office employee can also be very expensive when the cost of being short staffed, recruiting a new employee, and training that new employee is figured in. Using monetary incentives or extra vacation time incentives can be cheaper in the long run than hiring a replacement employee.

Vaccine mandates can make your business more competitive

Last week, I walked into a hotel that had a big sign on the front door stating “All of our employees are vaccinated for COVID-19 or wear face masks”. I felt much safer walking through that door and in the future will go to that hotel rather than one where I don’t know if I am safe being around the employees. Once you have all of your employees vaccinated, use that to your competitive advantage by publicizing it. A 70-year old diabetic with a skin rash can go to any dermatologist in town but is more likely to go to a dermatology office that advertises that all of the office staff are vaccinated. It is true that a conservative anti-vaxxer might be miffed at seeing such an advertisement but given that 90% of Americans over age 65 years old have received at least 1 dose of the COVID-19 vaccine, you are going to attract 9 older patients for every 1 who is put off by your employee vaccine mandate. Medicine is a business and with all businesses, success requires you to know your customers. Anti-vaxxers tend to be loud and get the most attention but they are a rather small minority of the population.

What is your legal liability if an unvaccinated infected employee gives a patient COVID-19?

To date, there has been no precedent for personal injury lawsuits if someone acquires COVID-19 at a business. Indeed, some states have laws that prevent people from suing a medical practice or business if they get infected from an exposure at that medical practice or business. However, until relatively recently, vaccines were not available to the entire adult population. Now that COVID-19 vaccines are widely available to any adult in the U.S. and that the U.S. is now giving away tens of millions of doses to other countries because we have a vaccine surplus, legal liability may change. It is possible that in the future, that if your 80-year-old immunosuppressed cancer patient gets COVID from your unvaccinated nurse and then dies, you could potentially face a personal injury or wrongful death suit. In a rapidly changing pandemic, it is not possible to predict the liability ramifications of unvaccinated healthcare workers in the future… it is safest to not take any chances. Some people view vaccine mandates similar to laws requiring people to wear a seatbelt – if you get in an accident, you are not going to be sued for not wearing a seatbelt. With vaccines now available, I see vaccine mandates more similar to laws regarding cell phones and driving – if you get in an accident while you are texting someone, there is a pretty good chance that you are going to get sued.

It is the right thing to do

The list of hospitals mandating employee vaccines is increasing daily. Nationally, organizations such as the Veteran’s Administration and Kaiser Health now require employees to be vaccinated. Here in Central Ohio, all 4 of our hospital systems now mandate COVID-19 vaccines for employees. The Hippocratic Oath that physicians take states: “First, do no harm“. It is morally appropriate to ensure that your patients are not harmed by one of your employees (and that your other employees are not harmed, also). As physicians, we are the ones who are most knowledgeable about vaccines and about COVID-19 so we should be the leaders in advocating for public health safety by requiring our office staff to be vaccinated.

The founder of Jet Blue Airlines, David Neeleman, once said that Jet Blue is a customer service organization that happens to fly airplanes. The same could be said about our medical office practices: we are customer service organizations that provide healthcare. In the midst of a pandemic, our customers want to feel safe in our businesses and it is incumbent on us to be sure that the patients who we serve feel safe in our medical offices.

August 4, 2021

Categories
Outpatient Practice

Should you hire an RN or an LPN for your office practice?

LPNs (licensed practical nurses) and RNs (registered nurses) have very different training and scopes of practice.  Understanding these differences will help you decide which one is best for specific outpatient office practices.

Differences In Training

It takes more training to become an RN than an LPN. Although the duration of  LPN programs can vary, one year is about average. LPNs typically train at community colleges or technical schools. On the other hand, to become an RN, the minimum training (associate degree) takes two years and most RNs will complete a bachelor of science in nursing degree (BSN) that takes about four years. Associate degree programs are generally found at community colleges and bachelor degrees are generally found at universities or 4-year colleges.

Many hospitals preferentially hire RNs who have a bachelor degree due to their more extensive education. Also, hospitals seeking “nursing magnet status” are required to have mostly RNs with bachelor degrees as opposed to those with associate degrees. In the outpatient physician office setting, the differences between RNs with associate degrees versus those with BSN degrees are less important since their scope of practice is similar and nursing magnet status is not relevant.

Differences In Scope Of Practice

Each state regulates what LPNs and RNs can and cannot do. In general, RNs are permitted to function independently and perform a higher level of assessment than LPNs. RNs are considered to be able to practice nursing independently whereas LPNs are considered to have a “dependent” practice, meaning that the LPN must work under the supervision of a physician, an RN, a podiatrist, a physician assistant, a dentist, etc. In most states, RNs, but not LPNs, can administer intravenous medications. For these reasons, hospitals have moved away from employing LPNs and now primarily employ RNs for inpatient care. However, in an outpatient office practice, there are more similarities rather than differences in the LPN and RN scopes of practice.

Either an LPN or an RN can perform the majority of nursing tasks in the outpatient office practice. For example, checking vital signs, teaching patients, taking phone messages, taking basic history information for the electronic medical record, scheduling tests, and administering vaccinations. Similarly, both types of nurses can perform common office procedures such as EKGs, spirometry, and influenza tests.

There are situations when an RN is preferable. For example, if intravenous medications are given in the physician office and RN is required. Also, when a higher level of assessment is required, such as answering sick calls to independently make recommendations to patients and RN is needed.

Where Do RNs And LPNs Work?

According to the U.S. Bureau of Labor Statistics, there were 721,700 LPNs working in 2019 (the most recent year data is available). The following is a breakdown of where they work:

  • 38% nursing homes and residential care facilities
  • 15% hospitals
  • 13% physician offices
  • 13% home health care
  • 6% government

In 2019, there were 3.1 million RNs working, four times the number of LPNs. The breakdown of RN job locations is:

  • 60% hospitals
  • 18% ambulatory care (including physicians’ offices, home healthcare, and outpatient care centers)
  • 7% nursing homes and residential care facilities
  • 5% government
  • 3% education

Salary Differences

In general, an RN will command a higher salary than an LPN due to the longer amount of training required and the greater scope of practice permitted by state nursing boards. According to the Bureau of Labor Statistics, the overall median annual income for an LPN in 2019 was $48,820 and the median annual income for an RN was $75,330. However, different locations of employment command different salaries. For example, hospital employment requires working weekends, nights, and holidays whereas physician offices are generally open only on during daytime on weekdays; thus nurses working in hospitals command higher salaries than those working in physician offices.

So, Do You Need An RN Or An LPN?

One of the central tenets of operational efficiency in healthcare is to allow employees to work at the top of their license. An implication of this is that you should not hire an RN to do an LPN’s job. When both salary and benefits are considered, an RN will cost $30,000 more per year; in other words, you can hire 3 LPNs for the cost of 2 RNs. Because of the lower cost of LPNs plus the fact that most nursing duties in the ambulatory office practice fall within the LPN scope of practice, LPNs are the right choice for most nursing positions in physician offices. Some physicians may not even need any RNs in the office. However, there are situations when an RN will be preferable to an LPN such as when intravenous medications are administered in the office and when the practice gets a lot of walk-in visits or ill calls from patients that require a higher degree of independent nursing assessment.

In multi-physician practices, some physicians will inevitably view having an RN (as opposed to an LPN) as a measure of prestige or of the physician’s self importance. I’ve often heard physicians say that they need to have an RN rooming their patients because: “…my patients are sicker”, “…I’m more senior”, or “…I see more patients”. However, vital signs taken by an RN are not any better than vital signs taken by an LPN. So, when those physicians are faced with taking a $30,000 reduction in salary in order to have an RN do the job of an LPN, they generally have second thoughts. A large multi-physician medical office will be most efficient with LPNs managing most of the day-to-day duties and then a smaller number of RNs for phone triaging, complex patient management, and supervisory roles.

RNs will continue to be the predominant type of nurses in our nation’s hospitals. In physician outpatient office practices, LPNs and RNs both have important roles. However, LPNs are considerably more cost-efficient for the majority of nursing roles in the office.

June 28, 2021

Categories
Outpatient Practice

Creating A COVID-19 Monoclonal Antibody Infusion Program

Two monoclonal antibodies have received emergency use authorization (EUA) by the U.S. Food and Drug Administration. Bamlanivimab (produced by Eli Lilly) and casirivimab/imdevimab (produced by Regeneron) were both approved in November 2020 as treatment for outpatients with COVID-19 and mild to moderate symptoms. The two drugs were studied in 2 different clinical trials in which each was compared to placebo with a primary outcome being detectable viral load on the days following treatment. Both drugs showed a reduction in viral load compared to placebo. But the clinically important findings were in secondary outcomes of need for subsequent hospitalization and duration of symptoms. Both drugs reduced the duration of symptoms from 6 days to 5 days. Both drugs also significantly reduced the need for hospitalization. Four subjects taking the combination drug casirivimab/imdevimab required subsequent hospitalization compared to 10 subjects taking placebo. In the other study, 3 subjects taking bamlanivimab required hospitalization versus 10 subjects taking placebo. This was great news to hospitals facing a surge of COVID-19 patients that threatened to overwhelm hospital and ICU beds. 

The FDA-approved indications were for outpatients (including patients in the emergency department that were planned to be released and not admitted to the hospital) with documented COVID-19 infection and not requiring supplemental oxygen (or an increase in normal oxygen flow rates if already on oxygen). Patients must have had symptoms for less than 10 days. In addition, patients must have at least one of the following risk factors for severe COVID-19 infection:

  • BMI ≥ 35
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or taking immunosuppressive medication
  • Age ≥ 65
  • Age ≥ 55 AND either cardiovascular disease, hypertension, or chronic respiratory disease
  • Age 12-17 AND either BMI ≥ 85th percentile for age/gender, sickle cell disease, heart disease, neurodevelopmental disease, medical-related technological dependence, or chronic respiratory disease (including asthma)

The challenge for hospitals and outpatient practices is how to identify those patients with COVID-19 who fit the criteria, create a safe location for the infusions to be given, and then get patients in for their infusions within 10 days of symptom onset. These are enormous logistical challenges. We had less than a week to prepare from the time the FDA approved the medications until Ohio began distribution of the drug. We received our first shipment of the drug on a Monday afternoon and were able to have our first patient get infused 90 minutes later. Here is how we did it at our hospital. 

Identify A Location For Infusions

Most hospitals have an infusion suite that can be used for chemotherapy to treat cancer or biologic drugs to treat autoimmune diseases. These areas are unsuitable to treat patients with COVID-19 because of the need to keep COVID patients far away from immunosuppressed patients. Ideally, the monoclonal antibody infusion location should be close to the hospital (for pharmacy, nursing, and physician support) and should have its own entrance so that patients with COVID do not have to walk through public hallways in the hospital. The area has to be large enough to accommodate the projected demand (on our busiest day so far, we treated 38 patients). We elected to use the auditorium at our hospital since it is large enough to handle up to 24 patients in the area at a time and has a separate entrance directly to the parking lot.

The Role Of Infection Control

Once we identified a suitable location, we had to be sure that it would be safe for patients and for the healthcare staff. Our infection control team checked the air flow in the auditorium and we were pleasantly surprised that the number of air exchanges in the room per hour was higher than our bronchoscopy suite! The floor was carpeted so we had our facilities team install a solid floor covering. We needed to have a separate entrance for healthcare staff that was different than the patient entrance so we put up a temporary wall in the auditorium lobby so that staff could enter through the hospital corridors and we could keep masks, gowns, and gloves in the staff entrance, away from the patient entrance. 

The Role Of Information Technology

Next, we had to ensure that there was computer access so that healthcare staff in the infusion suite could chart in the electronic medical record. This required augmenting our wireless signal strength in the auditorium. We had to create a separate monoclonal antibody infusion location in the electronic medical record for the purposes of scheduling and charting. We created an order set for an “E-consult to COVID monoclonal antibody infusion” so that physicians and other providers could order the infusion. 

The Role Of Pharmacy

When we received our supply of the drugs from the State of Ohio, we had to have a location to store and re-constitute the medication. Our hospital pharmacy was ideally suited for this since they already do this on a regular basis for inpatient medications. We assigned oversight to the pharmacist who also oversees our regular outpatient infusion center since she was experienced in the logistics of infusion drug preparation and delivery. 

The Role Of Nursing

Nursing represents the most staff-intensive component of the program. There has to be registered nurses experienced in placing IV catheters and in administering IV medications. There needs to be other staff who can check vital signs and assist with throughput; for example, outpatient medical assistants (MAs), inpatient patient care assistants (PCAs), or licensed practical nurses (LPNs). Because our infusion center needed to be up and running less than a week after the FDA made the approval announcement and because it was anticipated that the infusion center would be temporary (only lasting for a few months), we could not just go out an hire nurses and PCAs dedicated to the infusion location. Instead, we drew from nurses currently working in other locations within the hospital or ambulatory sites; we paid a lot of overtime.

The Role Of The Doctors

To ensure that the monoclonal antibody treatments were being used appropriately, we needed to have a process for review of the referrals. Rather than having primary care physicians order the infusion directly, we created an order in our electronic medical record for “E-consult for COVID monoclonal antibody infusion”. One of the pulmonologists became the designated consultant and he reviews each patient to be sure that the FDA-approved inclusion criteria are met. This was simplified by structuring the electronic medical record order for the consult to require that the ordering physician check boxes for the various inclusion criteria, such as age ≥ 65 or diabetes. 

In addition, Medicare requires physician oversight whenever infusions are performed. Fortunately, in January 2021, Medicare loosened the requirements from “direct supervision” to “general supervision”.  With direct supervision, a physician must be physically on-site in the building while infusions are being administered. With general supervision, the physician merely needs to be available by phone or video conferencing and does not need to be physically in the building. Since I am in the hospital most of the time, I became the designated physician supervisor – on those days that I am seeing patients in the outpatient clinic area, one of the hospitalists is my back-up, in the event that a patient must be seen in-person for medical attention. 

The Role Of The Legal Department

There are several compliance issues that we needed to address and fortunately, our legal department was able to provide immediate assistance to ensure that the infusion referral process was compliant with everything from the “general supervision” issue to physician referral. For example, it was recommended that a physician or other provider who has a pre-existing relationship with the patient be the one to contact the patient to inform them of their COVID diagnosis and determine if the patient wanted to be referred for treatment. In addition, we needed to register the auditorium with the state department of health as an outpatient treatment location.

Setting Up The Work Flow

We notified physicians at our medical center of the availability of the monoclonal antibody infusion suite and how to order a referral. However, we immediately found that many patients were self-referring to get their COVID-19 tests and so those test results did not necessarily get routed to a physician’s electronic medical record inbasket. Furthermore, many tests were ordered by surgeons, gastroenterologists, or other proceduralists as part of the patient’s pre-procedure evaluation and those results also did not get routed to a primary care practitioner. Therefore, we needed a way to identify patients with a positive COVID-19 test, determine if those patients meet the FDA approved indications, and then notify the appropriate physician or advanced practice provider that one of their patients meets criteria.

Once again, our information technology staff had an answer. They created an app within the electronic medical record that identifies all of the positive COVID-19 tests each day and then stratifies patients based on the number of FDA-approved risk factors for infusion. We do 500 – 1,000 COVID tests each day at our medical center and on some days, we can have more than 100 positive tests so the ability of the app to identify those patients who may be eligible was vital. When we first began our infusion center, I would run the app several times a day to identify eligible patients and then send a message to those patients’ primary care provider or other physician in our medical system alerting them and giving them instructions on how to order the e-consult. As our process evolved, we now have one of the pharmacists who works in the general internal medicine division and another pharmacist in the family medicine department take responsibility for positive tests ordered by physicians or providers in those departments. I now just review those patients whose tests were ordered from another department/division. 

Once the order for the e-consult is placed, my colleague reviews the consult and then enters an orderset for the infusion. That order goes to the pharmacy where a pharmacist reviews the orders and contacts the patient to schedule their infusion. We can generally get the patient infused within 24 hours. Patients are told to park in the parking lot adjacent to our auditorium/infusion suite and call a number that one of the infusion nurses answers. The patients are then directed where to enter the suite and are placed in a reclining chair. Nurses then do a nursing assessment, check vital signs, start the IV and administer the drug. The FDA requires that the infusion be given over 60 minutes and further requires that the patients be observed for 60 minutes after completing their infusion. Once the patients leave, the nurses route the electronic medical record encounter to me for review, supervision attestation and encounter closure. We operate the COVID-19 infusion suite daily from 8 AM to 5 PM, Monday through Saturday.

The medication is provided by the State of Ohio so there is no medication charge. The infusion can be billed under code M0239 (bamlanivimab) or M0243 (casirivimab/imdevimab); both are reimbursed by Medicare at $310.

Is It Making A Difference?

As of the day this post was written, we have given 442 infusions in our COVID-19 monoclonal antibody infusion suite. Statistically, this has prevented 31 COVID hospitalizations at our medical center and helped to reduce the strain on hospital resources from the current surge in patients. In addition, we have developed a similar process for our emergency departments so that patients with COVID meeting infusion criteria can be infused with monoclonal antibody and released from the ER. When an outbreak of COVID happened at a nearby nursing home this month, we partnered with the nursing home staff so that we gave infusions at the nursing home so that those residents did not need to be transported to our hospital’s infusion center. All told, we estimate that these efforts have prevented 50-60 hospitalizations in the past 1 month.

Winning the war against COVID-19 will not be done by any one intervention. It takes social distancing, face masks, hand hygiene,  availability of  testing, isolation of infected people, prompt initiation of treatment, and widespread vaccination. A monoclonal antibody infusion program is just one of these interventions but one that will pay off with reduced hospitalizations and lives saved.

December 20, 2020

Categories
Outpatient Practice

Telemedicine Across State Lines?

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

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

 

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

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

Each state has different laws about medical licensure

 

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

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

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

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

The COVID-19 emergency has changed state telemedicine regulations

 

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

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

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


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

So what is a physician supposed to do?

 

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

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

July 25, 2020