CloudMine.Logo.HiRes.type_1.png
Ë
Blog Home
By Matt Isbrecht • September 20, 2017

BioMed Plus - Adherence Lessons From the Past

The Case:

United States v. Martin J. Bradley III, et al., (AKA U.S. v. Bio-Med Plus)

In 1998 Bio-Med Plus, the largest privately held secondary pharmaceutical wholesaler at the time [1], began an intricate scheme to defraud both Florida and California’s Medicaid programs. The scheme consisted of a tangled web of wholesalers, doctors offices, shell companies, in-home care providers, and closed door pharmacies working in concert to sell expensive blood factor medications, purchase them back from patients illegally, then reselling those same medications again and again.

Blood factor medications which are primarily used for hemophilia and AIDS patients are administered via infusion, a process similar to a blood transfusion. This was pivotal to the scheme, as the doctors, nurses and techs involved were able to purchase unused medications from patients in the privacy of the patient’s home, or at closed door pharmacies who performed the infusions. This provided windfall profits for Bio-Med plus.

“Although these recycled blood-derivatives accounted for less than two and a half percent of Bio–Med's overall sales, they accounted for a much larger portion of Bio–Med's profits, yielding in excess of $39 million over a five-year span from 1998 through 2002.” [2]

As you might imagine this involved great risks to the patient’s health, as well as great financial costs to the patients and medical systems that treat them. Many of these costs have previously been addressed in a post titled “The Cost of Non-Adherence”, but Bio-Med expanded on these costs even further. The additional financial burdens of a multi-agency federal investigation, Medicaid losses, and a lengthy federal trial process that began in 2004 and did not conclude until 2012 [3], placed millions in additional costs squarely on the taxpayers shoulders.

This also opened up pharmaceutical manufacturers to costly litigation as well. Proliferation of schemes like this would cause an overabundance of billing of these products, in some cases billing for more product than was produced in a given year. Liability does not stop there though, at every point the product changes hands a certain amount of culpability is intrinsically inherited leaving every entity in the products flow to the patient open to scrutiny.   

Bio-Med is certainly not your average example of non-adherence, however it serves as a showcase for how deep the rabbit hole can go in extreme cases. It also allows us to examine how this fraud was executed, and how utilizing technologies that are available today could potentially have prevented this from happening.

Preventative Measures:

The key to preventing this type of fraudulent behavior begins by identifying the weakest points in the scheme, and disrupting them to make the behavior impossible. For Bio-Med the weakest and most pivotal point was the transaction between the patient and the doctor or technician doing the infusions. Given that this pivotal point is patient facing, the disruption should be designed to be as minimally invasive and time consuming as possible for the patient.

In this specific case infusion pumps capable of recording the infusion session, and reporting the amount of medication infused would be a good first step. This of course then begs the question, reporting to whom? The simple answer is, every approved member of the care team, which is no easy task.

To achieve this, the pumps would need to report the infusion metrics to a secure system of record. Depending on the size of the care team, that system would then need to communicate those metrics to multiple other systems such as health system EHRs, pharmacy systems, private insurance/payer systems, 3rd party tracking applications, and in this instance state run Medicaid systems. Providing all pertinent metrics to the approved care team allows for each entity to ensure the care plan is being followed, and to raise red flags if not.


Moving Forward:

While blood factor products were previously targeted due to their extremely high price, other pharmaceuticals are now being targeted due to popularity. Currently and for the past several years cases of large pharma companies and distributors being sued due to the epidemic of opiate abuse and subsequent deaths associated with that abuse are on the rise. In 2014 alone California sued 5 large opiate producers for aggressively marketing the medications, and creating the environment for abuse [4].

A quick search for “arrested for selling oxycodone” provides nearly 800,000 results, the top responses are not exactly what you might expect. The majority of stories are not about what most would consider the usual suspects, but rather licensed medical professionals prescribing these medications illegally to individuals for either personal recreational use, or for illegal distribution thereafter. In just one incident the LA times reported in July of last year that over 1 million oxycontin pills made their way into the hands of criminals and addicts. What's worse, the pharmacy Purdue Pharma allegedly had at least some knowledge of the fraud taking place, but took no steps to contact authorities [5]

Given the high costs of non-adherence, both physically and financially for every party involved, systems to ensure patient adherence are needed more than ever.


Lessons:

Non-Adherence has many contributing factors, some are more obvious than others but all pose serious physical and financial risks not just to the patient, but to manufacturer's, those involved in the care plan, and taxpayers as well.

The sharing of information across the care team is pivotal to the patient’s health, and can help identify non-adherence whether fraudulent or not.

Non-Adherence is not a new phenomenon, and given the upward trend of abuse, fraud and non-adherence are not going away anytime soon.

Advancements in technology which track patient adherence through automated IoT devices and self reporting can help curb or eliminate the impact Non-Adherence has on the patient and the care team.



References:

  1. https://www.justice.gov/usao-sdga/pr/victims-largest-fraud-case-prosecuted-southern-district-georgia-receive-over-27-milli-0
  2. http://caselaw.findlaw.com/us-11th-circuit/1572675.html
  3. http://lib.law.virginia.edu/Garrett/plea_agreements/dockets/Bio-Med_Plus.htm
  4. https://www.pm360online.com/five-pharmaceutical-companies-sued-in-response-to-opioid-addiction-epidemic/
  5. http://www.latimes.com/projects/la-me-oxycontin-part2/