It is always good when you see or hear bureaucrats communicating that they want to shrink government and make things efficient and useful. Only doing that which adds value is a way of life in the real business world.
So I was happy (but skeptical) when I saw the White House website “21st Century Government – Campaign to Cut Waste” which stems from Executive Order # 13576 on Government Efficiency, Effectiveness, and Accountability from June 13, 2011.
Here is a brief excerpt of the order:
“The American people must be able to trust that their Government is doing everything in its power to stop wasteful practices and earn a high return on every tax dollar that is spent. To strengthen that trust and deliver a smarter and leaner Government, my Administration will reinforce the performance and management reform gains achieved thus far; systematically identify additional reforms necessary to eliminate wasteful, duplicative, or otherwise inefficient programs; and publicize these reforms so that they may serve as a model across the Federal Government.”
At the same website, I found the following post: “Building a 21st Century Government by Cutting Duplication, Fragmentation, and Waste”:
“Yet, the Administration will not wait for congressional action. Where we can, we are taking aggressive action to eliminate overlap and reduce fragmentation administratively across government (emphasis added).
You get the gist of what they are trying to sell. Here is my favorite: Regulatory Reform.
Anyway, I came across something that I think was missed and I just need to get it off my chest. In the grand scheme of all the hundreds of millions if not billions of dollars wasted each year due to government inefficiency and regulatory mismatches and red tape, I am sure this is a small drop in the bucket. But a bigger concern than the wasted tax dollars, is the potential lack of access to clearly proven laboratory health services for millions of beneficiaries.
Here is the head scratcher. The federal government funds health plans. You know them as Medicare and Medicaid under the regulatory agency known as the CMS under the Department of Health and Human Services. The Secretary, Kathleen Sebelius reports to the President. There are also Federal Employee Health Benefits Plans and I think they are regulated under the office of Personnel Management which I believe to be an independent federal government agency.
Lastly there is TRICARE, a Military Health System benefits entitlement program administered by the Department of Defense. It has its own Secretary, Leon Pannetta, who reports to the President.
TRICARE Management Activity or TMA recently released word of a new Demonstration Project for something called Lab Developed Tests or LDTs. Below are pulled sections of a published justification and mission statement derived from the Office of the Secretary of Defense pulled from the Federal Register: that is announcing the need for doing the whole demonstration project. You may just want to read the whole thing to see the flow of TMAs thinking and justification.
An LDT is a test developed by a single clinical laboratory that
provides testing to the public but does not sell the lab kit to other
labs. In the past, these tests were relatively simple tests used to
diagnose or monitor diseases and other conditions within a single
laboratory usually at a local large hospital or academic medical
center. As a result the FDA has utilized enforcement discretion (where
the FDA does not enforce some or all applicable laws and regulations on
certain categories of products) of LDTs and has taken no action to
remove them from the marketplace.
In contrast to TMA, CMS regulations do not have a specific
requirement that devices be FDA approved. As a result CMS policy
provides a mechanism for the review and payment of non-FDA approved
LDTs (Section 522 of the Benefits Improvement and Protection Act). Non-
FDA approved LDTs which meet CMS’s standards are approved through its
National Coverage Determination (NCD) or Local Coverage Determination
(LCD) process. Once a LDT receives a LCD, it is considered a nationwide
Medicare covered benefit.
A demonstration project will be initiated by the TMA to test
whether CMS approved LDTs which have not received FDA medical device
510(k) clearance or premarket approval (therefore considered non-FDA
approved) are safe and effective for cost-sharing for TRICARE
beneficiaries. The LDTs for this demonstration would be limited to only
those that significantly inform clinical decision-making for
surveillance, surgical intervention, chemotherapy, or radiation therapy
for cancer.
What irks me as a taxpayer is that the DoD feels it has to expend however many hundreds of thousands or maybe even millions of dollars doing a complicated 3 year demonstration project to see if BRCA 1 and BRCA 2 tests and Oncotype gene tests (all are LDTs) can yield safe and helpful results to improve the health of TRICARE beneficiaries.
Why does TMA think it has to do all of this to prove something that likely is already proven by CMS? What does TMA think makes a CMS patient different than a TRICARE patient? If these lab tests are helping save Medicare or Medicaid lives under CMS, does TRICARE not think they can do the same for TRICARE lives, as if the payor source of the tests changes the outcomes? It it ludicrous.
The only reason TRICARE is doing this is because the Code of Federal Regulations has divergent rules that permit the same federal government from paying or not paying for the same exact tests under different health benefit programs! It is just a government red tape issue and not anything to do with proven and effective health care!
Why couldn’t the Department of Defense and TMA just ask for an executive order to cut through the red tape of the regulatory mismatching that makes the same exact tests being able to be covered under Medicare but not TRICARE go away?
Think about it. A TRICARE beneficiary becomes Medicare eligible at 65. So what is so magic about a lab test all of a sudden being proven as safe and reliable for good health outcomes when the person’s benefit plan eligibility changes from TRICARE as primary payor to Medicare? It is all red tape driven. Cut the red tape and save patients time and save taxpayers money.
If it is good for the federal government to fund payment under Medicare, why not make it good for the federal government to fund payment under TRICARE and vice versa? Fixing this issue now rather than doing a costly and wasteful demonstration project will certainly go a long way towards removing any skepticism that I have regarding the White House’s boasting on making government more efficient in the 21st century.
Living in America 