Did Medicare “Waste” $1.5 Billion on Defective Medical Devices?

graphic-heartMedicare did, according to an article in the Star Tribune on October 4th, 2016.

I doubt, however, the catastrophic heart failure patients who may have received such devices would consistently feel the money was “wasted”.  In our government’s zeal to recover Medicare losses, it seems that ‘no device’ may now be viewed as better than a ‘risky device’… but such heart disease remedies are by their very nature risky.  The more innovative the solution is, the riskier it is, as well.  Portable artificial implantable hearts may be among the riskiest types of devices around.  However, they may also represent the ONLY solution for those who suffer catastrophic heart failure when no donor heart is available.

Given the choice between a certainty of no life at all, and use of a new, very risky, technology… but one which might sustain you until a donor heart becomes available… which would you choose?  Would you want the choice to be made for you by a government agency?  Would you want the decision to be based upon what would best serve taxpayers, in general, but not what would best serve you, personally?  And… what if such devices were found to have an inherent flaw, but yours still worked?  Would you be willing to subject yourself to the risk of additional open heart surgery due to a recall… or would you do you best to figure out how to minimize your risk and be ready to act upon removal or replacement if, and only if, the device actually began to fail?

Is the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) categorizing costs associated with risky medical devices as “waste” based upon tax expenditures, without taking into account the limitations inherent to novel compassionate care solutions?  It was unfortunately really hard for me to tell.  hhs-oig-logo

The OIG 2016 Work Plan, indicates:  “We will review Medicare claims to identify the impact on beneficiary safety and quality of care, as well as the costs to Medicare, resulting from additional use of medical services associated with defective medical devices. Any determination of the impact on beneficiaries from a quality and safety perspective, and program costs, will require a determination of a reasonable means of tracking services from the recall of the medical devices in question. CMS [Centers for Medicare & Medicaid Services] has expressed concerns about the impact of the cost of replacement devices, including ancillary cost, on Medicare payments for inpatient and outpatient services.”

According to the Star Tribune article, citing a recently published report from U.S. Health and Human Services Inspector General Daniel Levinson:  “Medicare’s fiscal watchdog has documented $1.5 billion in spending on seven types of defective heart devices that doctors implanted in thousands of beneficiaries.”

The names of three manufacturers for the seven types of devices have not yet been released.

An estimated $140 million in deductibles and coinsurance costs was also spent by the recipients of the flawed devices, according to the report.

While it is true that an important part of what the HHS OIG does is detect and prevent wasteful medicare spending, especially in fraud-related cases, I’m not confident that the broad stroke with which ‘waste’ has been painted adequately takes into account compassionate care imperatives.

It is relatively easy to discuss the cost associated with flawed medical devices to tax payers if you don’t actually know or care about anybody relying upon such a device to stay alive.  If you or a loved one are among the patients impacted by decisions which prevent medicare coverage of continuing care for patients with implanted heart devices after recalls have been announced, the situation is entirely different and objectivity about cost can become justly lost in the emotional implications.

I suppose we, as a society, must always straddle the fine line between enough government spending oversight and the potential for over zealousness in that endeavor.  We DO need oversight of such spending and, for a bone-chilling, day to day, blow by blow, review of the latest news about the medicare-related corruption and crime being battled by the HHS OIG on behalf of taxpayers (and patients), visit and subscribe to updates on the HHS OIG newsroom website at:  https://oig.hhs.gov/newsroom/whats-new/ .

Meanwhile, my mission is to continue to ensure such devices, and the programs our society has implemented to help those who need such devices, are as much of what they are supposed to be for those who care as is humanly possible.  Sometimes I believe that includes affordability.  Sometimes I believe that includes reliability.  Not always, in either case, in my opinion.

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