394 - Genetic Testing Fraud, Lyme Update, Ultra-Processed Food and CVD
Take 3 – Practical Practice Pointers©
From the OIG and Question from a Colleague: Cave Ergo Medicus
1) Genetic Testing Fraud Reprise – Let the Doctor (& Patient) Beware
Question: I’ve been receiving forms from “genetic testing companies” that contain patient information and my own information requesting that I “approve” the patient’s request for genetic testing through the company. Are these requests legitimate?
Answer: When used correctly, genetic testing may offer opportunities to reshape the way healthcare is delivered and can potentially lead to substantial improvements in population health and individual health outcomes. Currently, most genetic tests
are only applicable in specific circumstances and any specific genetic test only needs to be performed once.
In 2019, the U.S. Department of HHS Office of Inspector General (OIG) alerted the public about a fraud scheme involving genetic testing. Genetic testing fraud occurs when Medicare is billed for a test or screening that was not medically necessary and/or was not ordered by a Medicare beneficiary's treating physician.
Scammers are offering Medicare beneficiaries "free" screenings or cheek swabs for genetic testing to obtain their Medicare information for identity theft or fraudulent billing purposes. They are targeting beneficiaries through telemarketing calls, booths at public events, health fairs, and door-to-door visits. Beneficiaries who agree to genetic testing or verify personal or Medicare information may receive a cheek swab, an in-person screening or a testing kit in the mail, even if it is not ordered by a physician or medically necessary. If Medicare denies the claim, the beneficiary could be responsible for the entire cost of the test, which could be thousands of dollars.
Additionally, some of these companies are obtaining patient data and then reaching out to patients and/or physicians to have them sign a form indicating approval. The Healthcare Fraud Prevention Partnership (HFPP) described existing problems with the use of genetic testing that are not related to actual or potential medical diagnoses, overuse of genetic testing where the tests have no clinical value (possibly related to an actual or potential medical diagnosis, but not germane to treatment decisions), and repeated genetic testing of the same person. HFPP also has noted that direct-to-consumer marketing is increasing patient demand for potentially unnecessary genetic testing. In some instances, physicians are obliging by ordering the unnecessary test.
The potential for and actual fraud around genetic testing is stunning (billions of dollars in 2018) and this will likely only get worse. I have recently received numerous requests from patients to sign/approve forms regarding such testing. The forms are quite detailed, and often include my own provider information (including NPI number). The “fine print” indicates that I will be the one who will receive and interpret these tests from my patients (if they are even legitimate in the first place). My encouragement is for all of us to be on the lookout for these requests, and to not “approve” any requests that you didn’t initiate as part of a legitimate work-up.
Healthcare Fraud Prevention Partnership: White Paper - Examining Clinical Laboratory Services. May 2018. Paper
HHS Office of the Inspector General: Fraud Alert – Genetic Testing Scam. September 27, 2019. Link
From the Guidelines and the IDSA, AAN, and ACR
2) Diagnosis and Management of Lyme Disease
Three different specialty societies – Infectious Diseases Society of America(IDSA), the American Academy of Neurology (AAN), and the American College of Rheumatology (ACR) – have joined forces to create clinical diagnosis and management guidelines for Lyme Disease. They followed the internationally known and well-accepted GRADE process for evaluating the evidence and creating their guideline recommendations. Of note, they did include representatives from primary care as well as patient and healthcare consumer representatives. In short – they used a valid guideline process.
There are 28 recommendations in the guideline, but I have grouped and summarized the ones relevant to primary care. Those with stars (*) have moderate to high-quality evidence behind them; the remainder are low-quality or “best practice”.
- Use DEET, picaridin, IR3535, oil of lemon eucalyptus, PMD, 2-undecanone, or permethrin to prevent tick bites.*
- Use tweezers to remove ticks, not chemicals, oils, or petroleum. Don’t burn them.
- Sending the tick for identification is OK, but don’t test the tick itself for B. burgdorferi – it doesn’t predict infection in humans.*
- Don’t test asymptomatic patients after a tick bite.*
- Give doxycycline 200 mg ONCE for a tick bite within 72 hours ONLY for all three criteria: 1) the tick was Ixodes spp., 2) the bite occurred in highly endemic area (Virginia counts) and 3) the tick was attached for>= 36 hours.*
- For erythema migrans (EM):
- Clinical diagnosis is sufficient if it’s typical-appearing EM.*
- Lab testing suggested if rash is atypical looking: acute-phase serum antibody (with convalescent titers if negative). Not polymerase chain reaction (PCR) or culture of either blood or skin.
- Treat with doxycycline (10 days), amoxicillin (14 days) or cefuroxime axetil (14 days). Only if allergic to all 3, azithromycin (7 days) is second line.*
- Southern tick-associated rash illness (STARI) occurs from Lone Star tick bites. If a rash happens after a tick bite, but the tick is unknown, treatment for EM is recommended as above. The guideline makes no recommendation for or against antibiotics for confirmed Lone Star tick bite rashes.
- For Lyme-associated neurologic disease:
- Testing should be with acute serum titers (and convalescent if negative).*
- If cerebrospinal fluid (CSF) testing is done, do serum testing at the same time to calculate the CSF:serum ratio. Don’t do PCR or culture on CSF.*
- Test for Lyme disease with epidemiologically plausible exposure to ticks and any of the following conditions: Cranial nerve palsies (mainly 7th and 8th, less so for numbers 3, 5, 6, etc.), meningitis, painful radiculitis, mononeuropathy multiplex, spinal cord (rarely brain) inflammation, especially with painful radiculitis.*
- Don’t test for Lyme for any other typical presentations of neurologic, psychiatric, or developmental disorders (in adults or children), or for any atypically-presenting disorder for which there is no plausible clinical or epidemiological support for tick bite.
- For neurologic infection, IV penicillin G, IV ceftriaxone, IV cefotaxime, or oral doxycycline is recommended for 14-21 days. IV medications can be changed to oral during treatment. For brain or spinal cord parenchymal involvement, IV antibiotics are preferred for the full course.*
- For Lyme-associated facial nerve palsy (7th nerve/Bell’s palsy), there is no recommendation for steroids in addition to antibiotics, HOWEVER, if Lyme disease is not yet diagnosed, steroids should be given according to other existing guidelines for this condition.
- Lyme carditis:
- Evaluate for carditis in patients with early Lyme disease with electrocardiogram ONLY if the following symptoms are present: dyspnea, edema, palpitations, lightheadedness, chest pain, or syncope. Hospitalize patients with PR prolongation (>300 milliseconds), other arrhythmias, or clinical manifestations of myo-pericarditis.
- Test patients with acute myocarditis and pericarditis for Lyme disease if it makes epidemiological sense. Do not test patients with unknown cause for chronic cardiomyopathy.
- Lyme arthritis:
- Test patients suspected of arthritis with the same serum titers as described above. PCR of the joint fluid or synovial tissue can be used if definitive diagnosis is required (but don’t culture these samples).*
- Treat with oral antibiotics for 28 days if diagnosis is made. If symptoms AND signs of arthritis persist, consider a repeat course of oral antibiotics vs. a month of IV ceftriaxone. If symptoms AND signs persist beyond this, refer to a rheumatologist. Do not treat persistent symptoms alone with additional courses of antibiotics.*
- There are several additional recommendations about less common presentations and specialty-oriented issues in the guideline. See the reference link below.
Lyme disease is endemic in Virginia (see CDC site here), so we need to be familiar with this and other tick-borne diseases here, but whether or not you are in an endemic area, tick-borne disease should be on your differential and a good travel history is essential.
This guideline is useful, and easy-to-follow, so I’d recommend getting a copy at the link below. Antibiotic stewardship is important, so trying to stick to evidence-based treatment recommendations like this guideline is the best way to preserve the usefulness of our antibiotics. There may be a new Lyme disease vaccine coming our way soon – a candidate inactivated vaccine in Europe is completing the necessary human trials and there is an agreement between the European company, Valneva, and Pfizer to make it available in the US and Europe when ready.
Lantos PM et al. Clinical Practice Guidelines by the IDSA, AAN, and ACR. 2020 Guidelines for the Prevention, Diagnosis, and Treatment of Lyme Disease. Arthritis & Rheumatology. 2021;73(1):12–20. Link
Briefly – From the Literature
3) Ultra-processed Foods and Cardiovascular Disease (CVD)
Ultra-processed foods provide 58% of total energy in the U.S. diet. The authors of this recently published study investigated the associations between ultra-processed foods and CVD incidence and mortality in the prospective Framingham Offspring Cohort. Three thousand + patients were prospectively followed for this study every 4 years from 1991 until 2017. The data indicated that higher consumption of ultra-processed foods is associated with increased risk of CVD incidence and mortality and suggest that limiting ultra-processed foods could have CV benefits.
This doesn’t bode well for our ability to impact the incidence of CVD, particularly given the daunting challenges of changing food choices. To do so will require food policy reform, public health education, and labeling changes. Additionally, since we eat what is available, affordable, familiar, and easy to prepare, improved access less-processed foods as well as education in preparation will be vital. As with any large-scale behavior change, making healthy choices easier and unhealthy choices more difficult will be essential. There are examples of how this can happen in specific localities, but the collective will of our country does not appear to be aligned with such an approach, which is why it often feels like we are “swimming upstream” as we try to help patients make better nutritional (and lifestyle in general) choices.
Mark and John
Carilion Clinic Department of Family and Community Medicine
Feel free to forward Take 3 to your colleagues. Glad to add them to the distribution list.