A Problem with non-FDA Approved Lab Developed Tests Under the Federal Government

Here is a link to an update on the DoD Lab Developed Test Demonstration (LDT) Project written by syndicated columnist Tom Philpott.

http://www.military.com/benefits/2014/02/06/dha-ops-chief-vows-relief-from-surprise-lab-fees.html

I first blogged about this demonstration project back when it was initiated in 2012.  As an occasional pundit of government waste, I was and maintain a troubled opinion that an entity working under the umbrella of the federal government would utilize regulatory red tape to guide healthcare policy decision making that would seek to limit patient access to likely proven medical care that could save lives.  If other federally run health plan programs such as Medicare and Medicaid and other health plans operating under the FEHB program ALREADY utilize LDTs that are not FDA approved and these tests are found NOT to be unsafe while possibly saving lives, then I struggle to relate to how in good conscience, TRICARE can use bureaucratic red tape under the guise of a timely and costly demonstration project to try and prove their appropriateness for use in practice.

Rather than force patients to wait for the outcome of its DoD study (potentially wasting precious time needed to get an early jump on a diagnosis) at the very least, TRICARE should seek to utilize already existing healthcare utilization data analytics derived from CMS and other data warehouses to do a case control look back as to the effectiveness of any LDTs in question.  There is likely a whole repository of experience under CMS using LDT’s.

Why force current TRICARE beneficiaries to do without are deemed standard of care tests unnecessarily?  I am glad to see that the issue of the direct care aka Military Treatment Facility (MTF) managed sector having the ability to use its own operation and management funds to pay for LDTs is being examined.  In the end though, if federal tax dollars are still being used to cover the cost of LDTs is on the MTF side or the purchased care side, then is it really a matter of FDA approval and effectiveness or is it just really a matter of where DoD MHS dollars are being spent?  The whole problem is borne from bureaucratic red tape entanglements.  So to a patient who needs the test to survive, it is easy to see the frustration of bureaucratic red tape getting in the way of good medicine.

It is time that congressional lawmakers get involved and set some legislative requirements to streamline data sharing for health programs and plans that operate under its jurisdiction using federal tax dollars.  A good place to start would be to recognize regulatory inconsistencies under ALL federal law, such as the use of LDT’s not yet cleared by the FDA and to begin requiring department and agency heads to work together to eliminate legislative barriers that do the public harm.

While congress is at it – (God willing) some additional  regulatory alignment type house work certainly be done with respect to who under TRICARE can prescribe Durable Medical Equipment and how much physical, occupational, and speech therapy is actually medically necessary.  That and ABA Therapy are huge expenditures that would appear to be requiring reigning in.  The courts have not done TRICARE any favors in that regard and DHA to its credit is trying to work out a practical solution.  I sure would hope to see capitated benefit limits on utilization of those services as in the private sector.  But all of that is a blog post for another day.  Hopefully they can get LDTs on track for less nonsensical management under federal control.