A Gallup Global Emotions Report, conducted in 2019, stated that “The World is angry and stressed.”  And that was before Covid-19 and political and racial upheavals, angst about vaccinations and now, virus variants, school closed or open, masks or no masks..

I hear the frustration and anger and distrust in so many conversations I have in the Type 1 diabetes communities.  The topics include but are not limited to:

• • • • • Cost of medications
        • CEO/Corp Exec salaries skyrocket
        • It’s hard to know which science to understand and believe
        • Companies controlling access to our data
        • Pharma and medical groups defrauding Medicare
        • We don’t know who to trust 
        • We are tired
        • We don’t feel respected by and heard by agencies (like FDA), corporations (makers of our devices), lawmakers, etc.

I’ve been thinking a lot about this … and how we can begin to fix these broken systems.  It’s going to be a tough challenge. I have no intention of stirring up your emotions in this blog … but rather just pointing out the crazy behaviors on the part of the healthcare providers, manufacturers, government agencies, app developers, etc.  THIS is WHY we are so stressed.  THIS is WHY we don’t trust what the “professionals” and political leaders and corporate executives tell us.

Here are some news stories just this week that illustrate these concerns and fears.

FDA ups premarket application user fees by 2.5% for FY 2022 was reported by Greg Slabodkin for MedTechDive.com, 2 August 2021.  INTERPRETATION:  Only companies with large funding will be able to apply for premarket approval.  

FDA announced fee rates and payment procedures for medical device user fees for fiscal year 2022, raising the medical device user fee by 2.5% for a premarket approval application.  The increase is far less than the 7% hike instituted last year. The base fee is $329,000 for a premarket application received by FDA during FY 2022, to apply from October 1, 2021, through September 30, 2022. The standard fee (adjusted base amount) for a premarket application, including a biologics license application, premarket report and a BLA efficacy supplement, is $374,858.

FDA’s total revenue amount for FY22 is nearly $213.7 million, which FDA notes is “a starting point to set the standard fee rates for each fee type” in order to meet its revenue target. The agency sets the fee rate for each type of submission based on a specified percentage of the standard fee for a premarket application.

The Federal Food, Drug, and Cosmetic Act, amended by the Medical Device User Fee Amendments of 2017, gives FDA the authority to collect user fees from industry for certain medical device submissions to help support the agency’s review activities.

Under MDUFA IV, the medtech industry provides $999.5 million to FDA over five years in additional financial resources and in return the agency is held to performance goals meant to improve the efficiency, predictability and transparency of its review process. These process improvements include significantly improved total review times for PMA and 510(k) submissions.

[Wait a second … the medical industry is giving money to the FDA to review their products?!  “If I give you more money, will you review my product more favorably and faster please?”  REALLY?!?!?]

AdvaMed had called MDUFA IV a “win-win-win” for patients, FDA, and innovation. However, the start of the reauthorization process for the fifth round of its medical device user fees program has exposed “fundamentally different” views in talks between FDA and device companies on the path forward.

Meeting minutes from a late April virtual event revealed disagreements over the FDA’s vision for its Total Product Life Cycle Advisory Program (TAP). Industry wants more predictable — and faster — premarket review times for medical device submissions and contends that TAP will add significantly to the complexity of the premarket review process, which has not been reliable as the FDA works through the disruption and heavy workload brought by the pandemic.

Read more:  FDA ups premarket application user fees by 2.5% for FY 2022

Patient deaths called ‘injury,’ ‘other’ in FDA medical device database published by Ricky Zipp for HealthCareDive.com, 2 August 2021.  According to a study, a researcher noted mislabeled patient death reports can go missed by the agency, potentially leading to unsafe devices remaining on the market.

A new analysis of the FDA’s Manufacturer and User Facility Device Experience database finds patient deaths associated with the use of medical devices are being mislabeled in the system and potentially being missed by the agency.

In a manual review of 1,000 adverse event medical device reports identified by a natural language processing algorithm, used to identify mislabeled patient death reports in the MAUDE system, 23% of reports were labeled as injury, malfunction, missing or other, rather than death, according to the study published last week in JAMA Internal Medicine.

The report raises more questions about the FDA’s complex and often opaque public reporting process and database for medical device adverse event reports. 

Madris Kinard, CEO of Device Events, which developed the software used to identify reports in the FDA’s database for the study, said identifying the correct number of deaths or serious injuries in mislabeled reports is crucial as it could potentially change the safety status of some devices.  “Accurate reporting of patient deaths allows the FDA to pursue investigations to determine if there is cause for concern, notify clinicians, and, when appropriate, take regulatory actions to protect patient safety. Thus, it is essential that all deaths be classified and reported appropriately as deaths,” authors of the study wrote.

Read more:  Patient deaths called ‘injury,’ ‘other’ in FDA medical device database

DOJ joins lawsuits alleging Kaiser Permanente committed Medicare fraud was written by Samantha Liss for HealthCareDive.com, 2 August 2021.   

The Department of Justice is intervening in six lawsuits that allege Kaiser Permanente submitted inaccurate diagnosis codes in order to receive higher reimbursement from the Medicare Advantage program. The suits allege Kaiser pressured physicians to add diagnoses to patient medical records — diagnoses they did not actually have — to boost patient risk scores to land higher payments. These records were allegedly altered months or up to a year later, the DOJ said. The six lawsuits were brought by whistleblowers, in one instance a Kaiser data employee, and maintain Kaiser violated the False Claims Act.

The government spends billions of dollars on the Medicare Advantage (MA) program each year as more seniors turn to the program over traditional Medicare coverage.   But a seemingly perennial issue in the program is plans attempting to game the system to secure higher payments. 

MA plans are paid on a per-member basis. Those payments are then adjusted to reflect the acuity or severity of the patient’s health status. Typically, the sicker a member is, the higher the reimbursement.   A recent report found that $2.6 billion was spent on diagnosis codes that were unjustified. It’s a problem federal regulators are concerned about, and attempting to keep a close watch on. 

[Are you saying to yourself at this moment, “How Dare They?!?!?”  I posted about Abbott’s $160 million fine for Medicare Advantage fraud just last week: Abbott pays $160M in Fines for Kickbacks]

Read more:  DOJ joins lawsuits alleging Kaiser Permanente committed Medicare fraud

What exactly are dieting apps doing with all your data? was written by Ruth Read for FastCompany.com, 4 August 2021. Nonprofit Privacy International’s new report shows how three dieting apps are collecting a lot of personal and medical data and may be sharing it with third parties.

If you’ve ever tried out a dieting app, you might have filled out a questionnaire asking you about your body type, weight, exercise, and eating habits, and possibly even medical information, like whether you have diabetes. Ostensibly that data is used to inform what kind of diet the app suggests, but new research reveals diet companies may be using it in other ways. According to London-based non-profit Privacy International, diet apps are sometimes sharing this data with third-party marketers and not protecting it securely. The report also raises questions around whether U.S. laws adequately protect online health data that isn’t hosted by a medical entity.

Among its other findings, Privacy International tested 3 diet apps: Noom, BetterMe, and VShred.  They found that information inputted into VShred’s website appeared in its URL, making it accessible by third-party ad platforms like Google Analytics, Facebook, and Yandex. On BetterMe, only information about gender seemed to show up in its URL data. Researchers also found that Noom actively shared all of its consumer data with a company called Fullstory, a data analytics firm.

While these companies are collecting health data (and in some cases medical information), that data is not protected under the Health Insurance Portability and Accountability Act (HIPAA). There isn’t transparency into whether this data is being well protected or used in ad targeting, says Privacy International senior researcher Eva Blum-Dumontet.

Blum-Dumontet also raises concern over who dieting companies may be targeting. A nonprofit called Anorexia and Bulimia Care has found that “eating disorder” and other similar words appear among suggested keywords for ad targeting. “Those ads can be really triggering,” says Blum-Dumontet. It can also lead people with disordered eating habits to engage in content they should otherwise stay away from, she says.

In an October 2020 lawsuit, both Noom and Fullstory were accused of illegal wiretapping, eavesdropping, and invasion of privacy for using technology to track what visitors do on the Noom website. In April, a judge dismissed the case on the grounds that the claim did not legally pass muster.  Despite this outcome, Blum-Dumontet says, the lawsuit is telling. “I think [the lawsuit] really shows the genuine concerns of users over this kind of behavior,” she says. “This behavior is concerning and raising a legal challenge is still completely on the table.” 

[Again, HOW DARE THEY?!?!?]

Read more:  What exactly are dieting apps doing with all your data?

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