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

Categories
Outpatient Practice

Optimizing Telemedicine Into Outpatient Clinical Practice

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

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

Patients like telemedicine

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

Telemedicine-only schedules

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

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

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

Combining telemedicine and in-person schedules

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

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

The fate of in-person-only schedules

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

So how should you structure your schedule templates?

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

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

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

June 23, 2020

Categories
Outpatient Practice

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

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

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

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

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

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

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

June 6, 2020

Categories
Epidemiology Outpatient Practice

Setting Up A COVID-19 Testing Station

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

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

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

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

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

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

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

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

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

March 24, 2020

Categories
Medical Economics Outpatient Practice

Prior Authorizations, Insurance Denials, and Physician Burnout

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

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

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

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

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

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

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

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

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

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

January 25, 2020

Categories
Outpatient Practice Physician Finances

Should Doctors Bill For Phone Calls?

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

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

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

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

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

Pros

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

Cons

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

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

December 1, 2019