Americans Have a Right to Basic Lab Tests

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February 21, 2017 | 41,406 views

Story at-a-glance

  • Direct-to-consumer laboratory tests can empower you to be proactive about taking care of your health
  • Doctors should not have exclusive rights to information about your body, including lab test results
  • The market for direct-to-consumer laboratory tests, which allow you to pick and choose which biomarkers of health you’d like to monitor, no physician’s visit required, was valued at $131 million in 2015 — up from $15 million in 2010

By Dr. Mercola

In the U.S., getting simple blood tests to monitor your health can be a time-consuming and expensive endeavor. Typically, you first must make an appointment with a physician, have the tests ordered by said physician and then wait for the results to come back, again through your physician.

Weeks and hundreds of dollars later, you may finally have your lab results in hand, but in an era where people are increasingly interested in taking control of their health, this physician-driven model has become antiquated and unnecessarily burdensome for patients.

No one has greater right to, or interest in, your lab work results than you do, which is why it should be a given that you can access such results directly from the company you pay to run the labs.

Beyond that, some companies are taking it a step further and offering direct-to-consumer laboratory tests, which allow you to pick and choose which biomarkers of health you'd like to monitor, no physician's visit required. The market for such testing was valued at $131 million in 2015 — up from $15 million in 2010.1

2014 Rule Gave Patients Direct Access to Lab Results

In case you've ever wondered if you can get your lab test results directly from the lab that conducted the testing, you do have that right.

In 2014, the U.S. Department of Health and Human Services (HHS) issued a final rule that granted a person (or a person designated by the patient) direct access to their laboratory test reports without having to have them sent to a physician first.

Clearly, doctors should not have exclusive rights to information about your body, but prior to this rule, this wasn't a guarantee. The final rule updated the Clinical Laboratory Improvement Amendments (CLIA) of 1988 , allowing laboratories to give patients direct access to their lab results.

Even so, it's not always as simple as it should be to get your results without going through your doctor. Laboratories may require patients to make requests for lab results in writing, and they may charge you extra to mail or electronically deliver them.

Further, the rule states that most results must be made available to patients within 30 days of the completion of testing, so you could be waiting weeks to find out crucial health information.2

Why You Should Have the Right to Monitor Your Own Health

Direct-to-consumer laboratory tests can empower you to be proactive about taking care of your health. If you know you're low in a certain vitamin or mineral, for instance, you can make efforts to increase it in your diet.

Or, if your A1C levels (a marker for diabetes) are normal but elevated near the pre-diabetic range, you can take steps to exercise more and change your diet to drive those levels down instead of allowing them to trend upward.

Critics of direct-to-consumer lab tests suggest the results are useless without a doctor to translate the results and provide related medical advice.

This may be true in some cases, but there are many tests results that provide fairly straightforward health information, once you know the optimal reference ranges where your results should fall into.

Further, doctors simply should not have exclusive rights to information about your body. This belongs to you, and it's up to you to do with it what you will, whether that be making an appointment with a physician to help you interpret the results or choosing to proceed otherwise.

New York State Attorney General Investigation Stopped Direct-Access Lab Testing

Even with the HHS final rule, laboratories can still be challenged for carrying out medical tests without the order of a licensed medical practitioner. In late 2015, for instance, the New York State attorney general accused DirectLabs and LabCorp of violating state law by doing just that.

The labs had been conducting health testing ranging from vitamin and heavy metal screening to checks for parasites, thyroid levels and cancer markers that had been ordered by a chiropractor who allegedly did not meet with the patients or follow up with them after the testing.

More than 1,000 patients used the service, which allowed them to get health information at a reduced price compared to normal. As a result of the investigation, a settlement was reached that stopped this direct-access lab testing without a licensed medical provider's involvement. The state's attorney general website reported:3

"The settlement with DirectLabs and LabCorp comes after an investigation by the Attorney General's Health Care Bureau showed that DirectLabs sold requisitions for a wide range of tests, and that these requisitions were automatically generated with a licensed chiropractor's name — who had never seen or spoken with the patients — in exchange for a $24 'access fee' payment.

Consumers could then take those requisitions to a LabCorp patient service center to have the testing performed at reduced prices negotiated between LabCorp and DirectLabs."

Walk-In Blood Tests With No Doctor's Visit Required

In stark contrast to New York, in Arizona patients can walk into laboratories and order a choice of tests on demand. Some labs even display the testing options on a price list, offering labs like a basic metabolic panel for just $17.4

This seemingly basic right to choose your own medical testing in Arizona is largely the result of intense lobbying by Theranos Inc., a blood-testing start-up firm that had hoped to identify illnesses from a finger prick instead of vials of drawn blood.

After failed inspections, the firm has closed its blood-testing facilities,5 but the doors it opened for companies offering direct-to-consumer testing using conventional methods remain.

Sonora Quest Laboratories, one company offering so-called direct access testing (DAT), reported 400 percent growth in the sector in 2016 and continued growth of more than 15 percent a month.6

Further, as Forbes reported, Sonora president and CEO Dave Dexter said, " … Doctors in the state have not been suddenly overwhelmed by anxious patients, and patients haven't been overwhelmed by the challenge of dealing with their data."

Instead, the patients have become empowered to become more deeply engaged with their health.

A number of companies have also started to allow patients to order hormone panels, test nutrient levels and markers of inflammation and more, then give the option to consult with doctors, nutritionists or other medical personnel for follow up.

In some cases, lifestyle changes, such as dietary and exercise recommendations or supplements, may be recommended. As Forbes reported:7

" … [A]s consumer testing becomes more common, you can expect a rapid growth in consumer-facing businesses that will help patients understand and interpret their results — or help the patient determine what he or she might want to order in the first place.

As the market for rapid and clear explanations grows, the quality of the services available to address this need is likely to improve in response to demand."

Research Suggests More Engaged Patients Have Better Health Outcomes

Putting health testing in the hands of patients is a logical progression of patient-centered health, and research even suggests that doing so may lead to better health outcomes.

In the journal Health Affairs, researchers looked into patient activation, or a person's willingness and ability to take independent actions to manage their health and care. "There is a growing body of evidence showing that patients who are more activated have better health outcomes and care experiences," they wrote, noting:8

" … [P]olicies and interventions aimed at strengthening patients' role in managing their health care can contribute to improved outcomes and that patient activation can — and should — be measured as an intermediate outcome of care that is linked to improved outcomes."

Favorable outcomes cited in the report among more activated patients include the following:9

4 Blood Tests I Advise Performing Annually

As direct-to-consumer lab tests become increasingly available, one of the first questions that probably come to mind is which tests are worth getting.

This is where having a relationship with a holistic health care provider can be valuable, as you can set up a baseline of which tests you should be monitoring and what your results should be (the reference ranges provided on lab test reports are not always accurate when it comes to optimal health).

This can vary considerably depending on your age, health status and health goals. There is no doubt, however, that having direct access to lab testing, and direct access to your results, is an invaluable way for you to take control of your health. As a general rule, I recommend getting the following four tests done on an annual basis, although others, such as uric acid level, may be beneficial as well.

Fasting insulin and glucose. Your fasting insulin level reflects how healthy your blood glucose levels are over time. A normal fasting blood insulin level is below 5, but ideally you'll want it below 3.

A fasting glucose level below 100 mg/dl suggests you're not insulin resistant, while a level between 100 and 125 confirms you have pre-diabetes and may indicate an increased risk of heart disease.

Serum ferritin. While many are iron deficient, which can lead to problems, having too much iron is just as common, and may be even more dangerous.

Iron is potent oxidative stress, so excess amounts can increase your risk of heart disease. Ideally, monitor your ferritin levels and make sure they are in the 60 to 80 ng/ml range.

To lower your iron level, either donate blood or get therapeutic phlebotomy.

Vitamin D. Optimizing your vitamin D is one of the easiest and least expensive things you can do for your health.

But, the only way to determine your optimal dose is to get your blood tested. Ideally you'll want to maintain a vitamin D serum level of between 40 and 60 ng/mL (100 and 150 nmol/L).

Fasting lipid panel, which includes total cholesterol, LDL, HDL and triglycerides. The key here is to focus on the ratio between these lipids, not the individual measurements in isolation.

To learn more, see "7 Factors to Consider if You're Told Your Cholesterol Is Too High." An NMR Lipoprofile can also provide a more accurate risk assessment.

[+]Sources and References [-]Sources and References

  • 1 The New York Times June 6, 2016
  • 2 Lab Tests Online March 3, 2014
  • 3 New York Attorney General, December 30, 2015
  • 4, 6, 7 Forbes February 6, 2017
  • 5 Tech Crunch January 17, 2017
  • 8, 9 Health Aff February 2013 vol. 32 no. 2 207-214
  • 10, 11 Health Serv Res. 2004 Aug; 39(4 Pt 1): 1005–1026.
  • 12 Res Brief. 2008 Oct;(8):1-9.
  • 13 Patient Educ Couns. 2009 Oct;77(1):116-22.
  • 14 J Ambul Care Manage. 2007 Jan-Mar;30(1):21-9.