Best practices distributor reps can use in preparation for the coming respiratory season.
By Jim Poggi, Principal, Tested Insights
As we approach respiratory season 2024-2025, one thing is certain: the number of respiratory pathogens the physician office needs to contend with is growing.
With this change, the amount of information the well-established distribution account manager needs to keep track of is increasing as well. This column will focus on best practices in being prepared for the coming respiratory season. It will provide a review of the past respiratory season and how it may predict this season. It will also discuss the major respiratory pathogens, vaccination, available tests and related reimbursement and some predictions of the coming season.
And for a little fun, I plan to take on some of the conventional wisdom that turns out to be more fantasy than fact. With the broad range of information available, your best resources include your key respiratory test manufacturers, vaccine manufacturers and your home office. To stay informed, you need to keep track of these resources and think clearly about how what you are learning will influence your customer discussions as we approach this respiratory season.
Respiratory season pathogens and dynamics
While we used to think of the coming respiratory season as “flu season, with a mix of strep cases,” in recent years it is clear that fall and winter in the U.S. and around the world has become a much broader respiratory season. After the emergence of COVID-19, public health resources raised the specter of a wider variety of respiratory pathogens than the public, and many physician practices, had thought of previously.
Influenza has always been forefront as a seasonal respiratory illness, with vaccination and testing commonplace.
The same is true of Group A strep, though it is known to occur throughout the year, with a seasonal spike in fall and winter.
While RSV has traditionally been thought of as a serious illness for infants, it is now recognized as a serious threat of respiratory infection in the young and old alike. The introduction of RSV vaccines targeted at the elderly population is evidence of this recent trend.
Add COVID to the mix, and respiratory season is a mixed bag of signs, symptoms, vaccination and testing opportunities. The 2024-2025 season brings with it more uncertainty than ever with a new COVID variant, KP.3.
Consequently, the number of respiratory pathogens your customers are interested in testing for has expanded significantly. So has the age range of the patients they are testing.
Respiratory testing past and progress
Our respiratory testing platforms have done an admirable job of keeping up with the emergence of pathogens and providing an exceptional range of available tests.
Group A strep tests have been available in lateral flow formats since the mid 1980s, followed closely by lateral flow influenza tests. But respiratory testing use in primary care seemed to plateau with lateral flow flu and Strep A tests being the predominant tests available from the mid-1980s through 2007. In the early going, strep was the dominant respiratory test required by just about every pediatric practice and many multi-specialty practices. Adoption of flu tests gradually grew in physician practices as waived flu A+B tests were made available. Along with the growth of flu testing came interest in improving the sensitivity and specificity of the current flu and strep tests.
At the same time, adoption of both tests led manufacturers to pursue development of additional new respiratory pathogen tests. These factors led to the development of lateral flow readers for flu and other pathogens including Group A strep and RSV in 2008. Respiratory test readers were in widespread usage by 2012. Their improvements in sensitivity and more objective reading results led to widespread adoption of these platforms. Only two years later in 2014, developments in simplifying molecular tests led to the first molecular assay for influenza. Since then, the race has been on among manufacturers to create and maintain their installed base of these platforms.
Today instrumented platforms for common respiratory platforms include visually read lateral flow assays, readers for lateral flow assays, fluorescent immunoassays, single strand displacement DNA/RNA test platforms, RT-PCR platforms and a multitude of other molecular assay types. Differential advantages include sensitivity, specificity, speed to first result, multiplexing of multiple assays at one time and ease of use.
Along with the growth of testing platforms, there have been improvements in LIS/EMR compatibility, ease of use and the range of available assays. Many of these very sophisticated molecular technology platforms are CLIA waived.
The emergence of COVID-19 and related “shelter at home” directives also led to the development and deployment of respiratory tests for COVID and other respiratory pathogens at home. While no-charge, home-use COVID tests are no longer available for home delivery, they are still available at no cost through local health care centers. Most states provide a listing of available locations where they are available. The range of respiratory tests today provides virtually every reasonable permutation of speed, cost, ease and test availability imaginable … until the next unexpected respiratory pathogen emerges. Is it any wonder your physician practice customers look to you and your key lab manufacturers for advice regarding which respiratory tests to perform and on which platform?
A word about vaccines
Vaccines for most respiratory pathogens are available at no cost for those with healthcare insurance. COVID-19 vaccines are available at no cost to insured and non-insured individuals alike.
Influenza. Ironically, while influenza received significant attention from pharmaceutical manufacturers and vaccines have been available since 1942, with the World Health Organization initiating tracking and reporting of influenza in 1952, adoption did not grow until the 1980s. In the U.S., vaccines underwent a number of improvements including the ability to immunize against a variety of influenza strains. Trivalent (vaccines targeting three subtypes) became available in 1968 and currently quadrivalent vaccines are commonplace.
The result? Influenza vaccines today provide a level of protection of up to four strains of flu A and B. While these improvements provide a high level of protection, there is progress still to be made. Flu vaccines need to be administered annually and their effectiveness ranges from 40 to 60% year to year, depending upon how well the vaccines target the flu strains anticipated in the coming influenza season. More on this later. In the 2022-2023 season up to 70% of all U.S. adults received the influenza vaccine, far outstripping adoption of the COVID vaccine.
Pneumonia vaccines. Pneumonia vaccines have been available since 1977 in the U.S. and are recommended for children over two years of age, adults and especially for elderly adults.
RSV vaccines. RSV vaccinations are recommended for expectant mothers, children under 19 months and adults over 60 years of age.
SARS-CoV-2 (COVID) vaccines. Both mRNA and non-mRNA vaccines are available for SARS CoV-2 and are encouraged. In the past year, CDC estimates about 22% of adults received the COVID vaccine.
Group A strep vaccines. There is currently no vaccine for Group A strep.
| Respiratory Pathogen* | Waived test available? | Reader/molecular platform(s) available | Common CPT codes | Reimbursement range |
| Influenza | Yes | Yes; multiple | 87-400QW; 87804QW; 87428QW (with SARS) | $16.55 for flu A OR B to $70.29 for flu plus SARS |
| Group A strep | Yes | Yes; multiple | 87430QW; 87650-; 97651-QWQW87880-QW | $16.81 for lateral flow visual to $41.76 for quantitative DNA probe |
| SARS-CoV-2 | Yes | Yes; multiple | 86769; 87811-QW; 87635-QW; 87636-QW (with flu); 87637-QW (with RSV) | $41.38-$142.63 Note: There MAY be other CPT codes |
| RSV | Yes | Yes; multiple | 87420-QW; 87807-QW | $13.10-$13.91 |
*Check with your key laboratory manufacturers for test availability and latest reimbursement advice. This table is for informational purposes and may not be comprehensive.
Looking back sometimes helps us look ahead
The 2023-2024 respiratory season was characterized by the end of the official COVID-19 pandemic on May 11, 2023, though COVID remained a serious health concern and remains on the list of the CDC’s leading causes of morbidity and mortality. COVID vaccinations are still available at no cost, and while adoption has waned from the peak of the pandemic, vaccination remains the most effective means of reducing the severity of a COVID infection.
COVID now appears to be settling into a more predictable seasonal incidence rate with the highest level of COVID cases reported in February 2024. From a peak of nearly 8,000 cases per day reported in February 2024, the latest data from March shows a reduction of COVID cases to just over 4,000 cases per day. Last season showed COVID incidence beginning to increase in August with a continuing rise in incidence peaking in February, followed by a gradual decline. There is every reason to believe it will behave in a similar fashion this year.
The CDC characterized the 2023-2024 respiratory season as moderate severity for adults and high severity for children. Type A influenza was the predominant strain in the past year, with H3N2 as the most common subtype. Vaccination for influenza remains a popular and reliable option, with estimates ranging from 44% to 70% of all Americans vaccinated for influenza. The latest vaccine effectiveness data comes from the prior season and CDC lists the effectiveness of the vaccine overall at 46% which is typical of most influenza seasons on record.
The positivity rate of influenza tests for the 2023-2024 season was reported at up to 16%. Flu A was more common throughout most of the season. Regarding the relatively low level of positive tests for influenza, there are several factors including sample collection and transportation, timing of swab collection and finally whether the disease was actually flu. Despite the increasing number of patients tested for other respiratory pathogens in recent years, the positivity rate for flu tests has remained relatively consistent over time.
The 2024 variants: what we know
For influenza, type A is expected to be the dominant strain again this year, with H3N2 most likely to be dominant again this year. While a new avian flu, H5N1 has made headlines based on transmission from animals to humans, there have only been five reported cases as of press time, and hopefully the spread of this pathogen will be rare.
The currently dominant strain of COVID-19 is KP.3, a member of the Omicron family. It currently represents 25% of all cases across the United states. Given the rapid mutation of the SARS-CoV-2 virus, there is no reliable way to predict whether this variant will continue to be dominant during the coming season.
Facts and fantasy about respiratory diseases
What we hear: “All nursing home patients get a vaccine; no need to test.”
Reality: While all nursing homes routinely administer influenza vaccines (and now COVID), the influenza vaccine is only about 27% effective in older adults and testing, particularly in high density living situations like nursing homes, can result in isolation of infected patients, limit the spread of infection and lower the risk of serious complications. The same general statements apply to COVID.
What we hear: “I can diagnose influenza, strep, COVID, etc. by signs and symptoms. I do not need to test.”
Reality: Only 16% of all flu tests performed on symptomatic patients turned out to be positive for flu. Other pathogens present with similar symptoms. Test to be sure.
What we hear: “The COVID pandemic is over; all good from here.”
Reality: Tell that to the 8,000 people who were diagnosed with COVID each day in February 2024. While the federal public health emergency for COVID expired on May 11, 2023, COVID remains a serious public health threat.
While we are presently in a seasonal lull for all respiratory illnesses including COVID, now is the time for you and the physician practices you support to be prepared with prevention, testing and treatment solutions. The most effective distribution account managers see respiratory season from every angle and provide the highest level of consultative assistance to their customers in every element of medical practice during respiratory season. They research disease trends, look for the best vaccination and testing solutions, and in collaboration with their key manufacturing partners, present objective information to their customers to help them make intelligent and informed decisions about how to manage respiratory season.
Are you ready? Are your customers? The best out there are. Be the best.