Why it’s time to reignite conversations around lipid tests.
By Jim Poggi
We have been talking about lipid testing for what seems like a lifetime now. Why on earth are we talking about it again? Sadly, because no matter how much we talk about it and the benefits routine lipid screening have on reducing heart disease, heart disease continues to win.
We have lipid tests, statins and even newer cholesterol drugs, but apparent indifference by a large portion of the U.S. population to practice better health habits is holding back progress. Heart disease remains the number one leading cause of death in the United States, and the latest data published by the National Center for Health Statistics shows an increase in mortality from heart disease from 2019 to 2020.
The tried-and-true lipid assays, used in combination with statins, diet and exercise routine have comprised the routine medical practice for management of lipid levels and are intended to reduce the risk of cardiac events including heart attack and also stroke.
There are good reasons for the use of lipid profile tests and whether your customers are using waived bench top systems or testing for conventional lipid tests (Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) on larger non-waived systems, the data is there to support use of these tests. The United States Preventive Task Force assigns an “A” rating to screening in men over 35 years of age and for women over 45 years of age irrespective of known risk factors. They assign a “B” rating for lipid testing for men in the 20-35 age group if they are at increased risk of coronary heart disease and the same rating and recommendation for women in the 20-45 years of age group.
The supporting evidence for lipid testing is overwhelming and includes data and recommendations by CDC, NIH, AMA and multiple well respected teaching hospitals. The MR-FIT study ran from 1972 to 1998 and enrolled over 12,000 participants and proved conclusively that exercise, diet and reduction in cholesterol was associated with a reduction in heart attack and coronary events in general. As additional rationale, elevated lipid levels are directly associated with three of the ten leading causes of death: heart disease, stroke and kidney disease.
In addition, in combination with other factors, lipid levels are also associated with diabetes. In total, they account for diseases associated with 40% of all the leading causes of morbidity and mortality in the U.S. today. Is it any wonder that diagnosis and treatment of patients with elevated lipids is a major focus for primary care health practices across the U.S.? I am confident that the majority of your customers are prescribing statins and even newer agents including ezetimibe that lowers cholesterol by a different mechanism than statins.
But, are they providing lipid measurements at the point of care where they can provide immediate counseling on diet and lifestyle or are these opportunities being missed? The best primary care practices today are combining traditional guidelines for lipid measurement with newer recommendations to engage in personalized medicine for patients with additional risk factors. What are these risk factors? Smoking, obesity and uncontrolled blood pressure raise the risk of cardiovascular disease and these are logical patients for more aggressive treatment including more frequent lipid measurements. While smoking has decreased, the other two risk factors have not.
Forty percent of the U.S. adult population is classified as obese and the rate of obesity in children is rising. Furthermore, over 75% of the adults in the U.S. with hypertension are classified as “uncontrolled.” That’s just about 100 million American adults.
What are you and your trusted lab manufacturers doing to create a holistic approach to the control of heart disease risk factors? There are antihypertensive drugs that effectively control hypertension, multiple lipid lowering agents including statins and ezetimibe and the new generation of drugs intended to lower hemoglobin A1c that also assist in weight reduction, GLP-1 agonists. If you haven’t heard one or more commercials on the television for these agents and do not have an ear wig for the song of one of them, be grateful.
The point is, a holistic program of identifying at-risk patients, using the medications as needed to control their risk factors and providing lipid testing at proper intervals can make a difference in your community and ultimately across the entire U.S. health system.
Have you started your discussions with key customers? Have you engaged in discussions with customers who have benchtop lipid systems but have stopped using them? It’s worth your time to develop a program with your key lab manufacturers and present it to your most forward-thinking customers as a thoughtful and trusted consultant. They know this information but many of even the best practices are not engaging in a systematic approach to controlling cardiovascular risk. Many others are not using the tools they have at hand.
If you carefully research your key customer base, unfortunately, you should find plenty of prospects. In my experience, there are many waived bench top systems in place but not being used. A simple discussion centered around the current approach to testing for lipids and a thoughtful discussion around the rationale to test should get a productive conversation going.
For example, “I was recently reading about the incidence of cardiac risk factors as well as the United States Preventive Services Task Force lipid testing recommendations, and I learned a lot. May I share a few facts with you?”
That’s not a bad ice breaker, but, working with your trusted lab manufacturers, I am sure you can customize your initial statement to be interesting and provocative. You will need a sound attention getter to open the conversation.
My assessment is that many of the practices that have stopped in-office lipid testing got exhausted and frustrated when they did not see patient progress. Some may be convincible if you can get them excited again. I would specifically ask if they suspended testing due to lack of patient progress. Check with your key lab manufacturer to see if they have patient education information to supplement counseling by the practice. This extra help may be the incentive they need to give in-office lipid testing another try.
What’s old but under used?
While “new” lipid tests have been around for over 30 years and have significant supporting evidence, the use of assays for Lp(a) and ApoB have been exceptionally slow to catch on in the United States. However, the combination of personalized health initiatives, new medications which target lowering LDL specifically and the rapidly increasing use of GLP-1 agonists point to a change in lipid profiling.
What, exactly, are these old but new to many of us lipoproteins? First, they have been around in the literature since the 1990s and have gained adherents in Europe. Both complement Cholesterol, HDL and LDL. Lipoprotein (a) (Lp(a) is a variant of LDL cholesterol. Elevated levels of Lp(a) are associated with increased risk of cardiovascular disease.
In addition to the typical lipids we measure, Lp(a) is considered an independent risk factor for cardiovascular disease. Lp(a) is known to be responsible for the formation of arterial atherosclerotic plaques. ApoB is a name given to an assortment of lipoproteins including very low-density lipoprotein and low-density lipoprotein, also known as LDL. ApoB is the lipoprotein that actually makes up the structure of plaques. So Lp(a) and ApoB are independent entities and each has a role to play in the development of atherosclerosis.
Although few lab companies today offer these assays, making it unlikely that your customers are asking you for them, why am I mentioning them? Because they are important to know in the overall story of lipid testing and lipid medications.
Despite the fact that these two assays are rarely performed, the good news is that some are coming to market. Will they become mainstream assays? Probably not. It is more likely that they will be used selectively in patients with poor responses to conventional lipid lowering agents or those with a family history suggesting abnormal lipid metabolism.
There are several CPT codes listed in the Clinical Lab Fee Schedule, with the most pertinent being 83695, “Lipoprotein A level”. It is a national CPT code, and it pays $14.32. Some manufacturers are beginning to develop and commercialize these assays and your best bet for more information is to touch base with your trusted lab manufacturers that offer non-waived assays and ask them for more information.
From my perspective, it is difficult to predict the future of these assays. Unless there is a drug that comes along specifically targeted to them, I believe they are likely to be confined to IDN core labs and reference labs. But stranger things have happened, and it is worth your time to check in with a manufacturer or two of large non-waived chemistry systems to get their take on these assays and their future.
What makes sense to do?
If I had a territory, I would check in with a cross section of my customers with waived bench top systems that either are not used at all or have limited use. Your sales reports should easily provide you with this information.
As always, start with the questions:
- “What caused you to acquire this system?”
- “How has it performed for you?”
- “I see you are not using it. Can you tell me why?”
With that information, I would make sure their practice demographic is similar to when they acquired the system and I would suggest: “I can bring in an expert on this system who can address your concerns and help make this system productive for you and your patients. May we make an appointment for this discussion? If we can find ways to address and resolve these issues, would you consider re-instituting testing on it?”
If they say no, ask why and if you cannot address their concerns effectively, move on and think about finding a different way to address their issues at another time.
If they say yes, make sure you ask to have customer technical personnel and decision makers in the meeting.
And ask for a range of dates. Work out the best date with your lab manufacturer and firm up the date as soon as possible. It is in the interests of your customer, their patients, you and your lab manufacturer to make sure that lipid testing becomes a routine part of their daily work as soon as possible. Your job with these customers is for them to become excited again and to feel that they can make a difference. Any new manufacturer support literature will be helpful here.
We all experience headwinds in our territories. How we address them determines our success and the value we bring to our customers and the importance they associate to their relationship with us. Re-activating a system that once seemed to have value but has fallen out of use is a strong way to help establish the concern you have for your customer and their success. Your specific job with this customer group is to learn what caused them to become discouraged (that’s why they stopped testing in-house) and to bring that excitement and confidence that they can make a difference with this patient group back.
Essentially, you will act as a cheer leader. While this column discussed how to work to re-establish lipid testing, the principles we have discussed apply far more broadly. Use them successfully and you will earn your customers’ respect.