Last month I wrote a series of articles (starting here) about HDL, a laboratory company under investigation by the DOJ for giving kickbacks to physicians who use their tests. I reported additional allegations of serious misconduct based on questionable sales, marketing, and billing practices involving unnecessary testing. In response to those articles I’ve received emails from several individuals, including a patient and a health care provider, whose stories appear to confirm and provide additional perspective about the allegations in the earlier articles.
“Your test results are giving me a heart attack!”
Like many 70-year-old women, Mary (not her real name) has a number of medical conditions, including mild hypertension, type 2 diabetes, and polycystic kidney disease. She feels grateful that her conditions have been reasonably well controlled, including use of a moderate-intensity statin, and that she has been able to maintain an active life. She recently moved to a new state where she found a new doctor, a family physician, who ordered the full HDL panel of tests. He assured her that she would not be charged for the test. (HDL billed Medicare more than $4,000 for the tests. Medicare paid more than $700.)
The doctor explained the purpose of the tests and what they would reveal. Regarding the various cholesterol tests he told her that lipoproteins are like little cars in the bloodstream and that some cars were being driven by teenagers, who were dangerous, and some by adults, who were not dangerous. When the test came back the doctor told her that it showed that her “cars had teenagers and not adults driving around” and that she required more aggressive treatment. He also told her that because she didn’t have the apoE4 variant she didn’t have to worry about getting Alzheimer’s disease.
He then sold her a package of supplements containing fish oil, niacin, and vitamin B3, which cost Mary about $60 for a month’s supply. Initially Mary thought she had no choice but to comply. He also scheduled her for an appointment in three months to come in to have the entire panel repeated.
But later she felt violated. “I wasn’t going to the hairdresser selling me shampoo, I was going to the doctor,” she told me. “It’s very upsetting when someone tells you that you’re going to have a heart attack. I wanted to tell him that the results he was telling me were going to give me a heart attack.”
She gave her old doctor a call and told him what had happened. He said that he was aware of HDL and similar lab companies and would never used them. He advised her to ignore the test results and throw out the supplements. He also said that if he had a test that could tell if someone would get Alzheimer’s he would be rich and retired by now. (The presence of apoE4 indicates an elevated risk for Alzheimer’s disease but its absence does not imply immunity from the disease.)
Mary then called the new doctor to cancel the repeat test. On the phone the nurse said that Mary had “serious heart problems and had to have the test done.” She then asked the nurse why, if her heart problems were so serious, didn’t he send her to a cardiologist”? The nurse didn’t have a response, and when Mary asked her to have the doctor call her back she was told that he doesn’t call patients.
I asked Dr. James Stein, a cardiologist and the Director of Preventive Cardiology at the University of Wisconsin Hospital and Clinics, to review her case based on her story and the lab reports from HDL. After cautioning that he had not seen her himself he said that “a few points are very clear from reviewing her report. First, this represents a shameful overuse of tests that inevitably lead to more testing and more – usually unproven – medical interventions at significant expense to the patient and/or the health care system. Second, the vast majority of these tests are not needed. Some are standard – the lipid panel, checking her glucose, hemoglobin A1C, thyroid, uric acid, maybe even hsCRP. The rest of the tests are expensive, not indicated, and have potential for harm, especially the genetic tests.”
Stein also said that the report itself was “quite bombastic, with big red boxes that scare the patient. Her red boxes focused on insulin resistance and diabetes – which she has – but it is well controlled.” The report also recommended fish oil and niacin, but “there is no proof that adding these drugs to statins or doubling their doses will help a patient like her. Indeed, they are more likely to worsen her insulin resistance and may lead to other side effects and additional expenses.”
The Phlebotomist’s Tale
Susan (not her real name) is a phlebotomist (someone who draws blood) who was recently hired as a temporary worker by HDL to work in the office of a doctor who specializes in “age management.” She gave a behind-the-scenes perspective on the HDL scam in clinical practice.
First she explained how the no-payment policy worked in her office. Although she handed patients a pre-printed form that said the patient might be responsible for payment under some circumstances, “I was instructed to write a note at the bottom of the page in large letters with a black Sharpie instructing the patient to contact the sales rep (with name and phone number provided) if they should actually receive a bill, with the outcome that the patient would owe nothing.”
She told me that she was also given a list of 10 international diagnostic codes (ICD-9) and told to add these codes to the forms for every patient, whether accurate or not. Until she asked for clarification, her instructions even included a code indicating that the patient was post-menopausal, even when her patients were younger women and men. She emphasized to me that she had no training in choosing these codes, and that she had no access to her patients’ medical records and no information about their medical conditions.