FDA Issues Cautionary Guidance on Right-to-Repair

Technology is a critical to the current and future success of our healthcare system. Innovation will continue to transform the system, improving patient outcomes, enhancing operational efficiency, and reducing costs. On the other hand, ensuring this technology infrastructure maintains specific regulatory standards necessary for protecting patients takes care and accountability.

In fact, a guidance recently published by the U.S. Food and Drug Administration (FDA) outlining thoughts on the repair of medical devices and technology used by our nation’s health professional had one major takeaway - "proceed with caution."

Some believe that a consumer's so-called "right to repair" should include FDA-regulated medical devices like MRI machines, ventilators, and dialysis machines. On the other side, many argue that serious unintended, negative consequences for patient health and safety will result when unregulated third-party repairmen are allowed to work on such highly sophisticated and sensitive devices.

Right to repair advocates point to a 2018 FDA report to argue the agency agreed to "take a pass" on regulating third party device servicing because they could find no evidence of a problem. Cherry-picked quotes describe third-party servicers as providing "high quality, safe, and effective servicing of medical devices ... critical to the functioning of the U.S. healthcare system." But these messages are out of context, wrong and dangerous.

The fact of the matter is that the FDA is very concerned about allowing third party repairs by entities that are unregulated by the agency and often ignore important components of regulatory oversight such as adverse reporting. The FDA is very aware that unrestricted right to repair would likely open the flood gates to a host of unknown servicers who could negatively impact both the safety and effectiveness of crucial medical technologies, putting patients' lives at risk.

The agency's concern is multiplied by the dearth of facts and figures. The FDA doesn't have enough data to make a definitive conclusion about third party servicing because unregulated service providers aren't required to register with the agency. The FDA can't even establish how many third-party servicers are out there - though the agency estimates there are between 16,000 - 21,000.

But the subject at the heart of the issue is the definition of when “servicing” becomes “remanufacturing.”  In the FDA's Final Guidance, the agency writes, "the distinction between 'remanufacturing' and 'servicing' is important to understand." Not only is it a distinction with a difference – it is a distinction that makes a difference.

Defining a repair as remanufacturing requires a heightened applicability of enforcement and regulatory standards as opposed to run-of-the-mill servicing. The new guidance makes clear that if an entity is remanufacturing, they will be subject to the same strict regulatory requirements as the original manufacturer of the device. That includes sharing detailed records and adverse reports the FDA needs to enforce the high standards these technologies require to operate properly - standards not currently enforced on third party right to repair organizations.

In short, if a third-party service company isn't familiar with FDA regulations, doesn't have an internal compliance department, or is ignorant as to ow to identify, collect, and report adverse events on the advanced technologies it services, well, "White Oak, we've got a problem."

The FDA doesn't have the regulatory authority to allow or ban third party repair. So, to portray this Final Guidance as, in any way, supportive of the right-to-repair philosophy is intellectually dishonest. It's more accurate that the agency is offering advice to protect the healthcare ecosystem against some very dire - and predictable - unintended consequences.

When it comes to healthcare technologies, responsibly, transparency, and accountability are paramount. If history is any guide, lawsuits aimed at faulty medical devices aren't aimed at small "servicing" concerns, they're laser focused on the deep pocket of the original manufacturer. And frivolous lawsuits inevitably raise the costs of these important technologies, exacerbating reimbursement issues, and further limiting access to urgent medical tests among health care systems already facing strapped budgets. 

Kudos to the FDA for addressing the issue head-on and admitting the scope and severity of the problem we are facing when it comes to the continued quality, safety, and effectiveness of medical devices. And while right to repair has merits when applied to a whole host of products, caution is not something we can throw aside when it comes to medical devices.

Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.

https://www.realclearhealth.com/blog/2024/06/13/fda_issues_cautionary_guidance_on_right-to-repair_1037959.html

Health Insurers on the Dole

 It is a lucrative time for the health insurance industry. This year, the largest carriers have reported record profits, and the stock prices of major insurers have risen more than eightfold since 2010, greatly outperforming the S&P 500 index. But the share of Americans purchasing private insurance has fallen steadily since the 1960s, so what gives? Insurers’ surging profits owe largely to their new favorite customer: Uncle Sam.

A half-century ago, Americans were covered either by privately purchased health insurance or by government programs that paid directly for medical care. But the rapid growth of Medicare Advantage, Medicaid managed care, and the Obamacare exchange plans means that around 100 million Americans now receive publicly subsidized health care administered by private insurers.

The government is catching up with employers (who cover 158 million people) as the insurance industry’s main source of revenue. And insurers’ profit margins on Medicare and Medicaid enrollees in 2022 were more than twice as high as those on sales to employers and individuals. As a result, McKinsey estimates, public revenues will account for almost two-thirds of insurer earnings by 2027.

Using private insurers to administer health-care entitlement programs was originally intended to save taxpayers money. In the 1990s, managed care achieved a historically unique slowdown in the growth of private health-care costs by negotiating discounts, steering patients toward cost-effective providers, and reducing inappropriate utilization. Policymakers sought to bring this dynamic to the public sector.

In many ways, allowing elderly and disabled Medicare beneficiaries to opt for privately administered Medicare Advantage (MA) plans has been successful. Plans are paid up-front in monthly fees to deliver Medicare benefits to recipients, providing an incentive for insurers to forestall costly hospitalizations. Medicare Advantage participants have seen better health outcomes, and changes in medical practice styles have generated spillover benefits even for those not in the program. These plans have used funds to reduce premiums and out-of-pocket costs and to pay for normally uncovered supplemental benefits, such as dental care. The share of Medicare beneficiaries enrolled in MA has leapt from 19 percent in 2007 to 52 percent in 2023.

Payments to MA plans are based on average spending levels under the government-managed Medicare plan, adjusted for recorded differences in patients’ medical needs. But the congressional Medicare Payment Advisory Commission (MedPAC) has recently concluded that the government is overpaying private insurers by $83 billion, because payment incentives have led insurers to be disproportionately expansive in documenting patients’ medical conditions.

A similar desire to generate savings with managed care fueled the expanding private administration of Medicaid, in which 74 percent of Medicaid beneficiaries were enrolled in 2021. But a 2018 Congressional Budget Office assessment noted that, while “states have argued that Medicaid managed care reduces spending and improves outcomes,” studies “have not found evidence to support those claims.”

States can claim between $1 and $9 in federal funding for every $1 of their own resources that they spend on Medicaid—without an upper limit. This extraordinarily generous arrangement is limited to expenditures on covered health-care benefits for eligible low-income beneficiaries, however. To circumvent these restrictions, states have claimed waivers from the program’s rules—letting them obtain federal funds for nonstandard purposes.

Though the federal government resists approving waivers that raise overall program costs, states can make net increases in noncovered program expenses hard to identify by aggregating funds for various services into lump-sum payments to insurers. Axios recently reported that Medicaid insurers were spending billions of dollars on new “affordable housing” and “philanthropic” ventures—failing to mention the incentives they have to undertake extraneous expenditures to win contracts from state officials, largely paid for with federal money.

The absence of premiums or out-of-pocket costs for Medicaid recipients has made the program highly vulnerable to improper payments. In 2022, 26 million of the 88 million Americans in Medicaid and the Children’s Health Insurance Program, for which insurers received monthly payments from the government, didn’t even know they were enrolled. Employer-provided insurance plans already covered many of them.

Similar problems have afflicted the Obamacare exchange. To boost demand for these privately managed plans, Congress and President Biden expanded subsidies so that Washington would pay 100 percent of premiums for families of four with incomes less than $46,800. This led to a surge in participants, and half of those in exchange plans now get free coverage. Yet, the Biden administration’s eagerness to boast of rising enrollment, regardless of the cost to taxpayers, led to insurance brokers fraudulently enlisting tens of thousands into plans without their consent.

Due to the extent of subsidies, few Obamacare exchange participants are price sensitive when selecting plans. In 2023, 79 percent received subsidies that automatically increase with benchmark premiums. This has encouraged insurers to push up prices.

Seeking to inflate its revenues, the health-care industry has fostered an exaggerated view of the importance of insurance coverage. Through a combination of payments for services by patients and direct subsidies to hospitals, America’s uninsured receive about 80 percent of the medical care they would get if they were insured. Enrollment in Medicaid increases utilization of medical services, boosts medical provider revenues, and reduces patients’ out-of-pocket costs—but it does not significantly improve measured physical health outcomes.

To curb the overpayments, Congress should, first, let the Biden-era expansion of exchange subsidies expire, and allow the establishment of a parallel, fully privately financed insurance market. Second, it should cap Medicaid payments to states, so that states and insurers can’t claim federal funds to pay premiums for beneficiaries whom they know will use no care. Third, it should pare back payments to Medicare Advantage plans, so that insurers get the same amount for covering Medicare patients as the federal government would spend purchasing health care for them directly.

Chris Pope is a senior fellow at the Manhattan Institute.

https://www.city-journal.org/article/health-insurers-on-the-dole

States Must Fight Out-of-State Influence in Our Elections

 The unrelenting flow of money into our elections is threatening the conservative values we hold dear, among which are local control and representative self-government. There is too much political power in the hands of a few people, who are often out-of-state billionaires funneling their money through dark money special interest groups and shell corporations.

This isn’t just our opinion. The system is broken, and it’s affecting all of us. In the midst of an otherwise divisive election cycle, this is an issue that unites nearly all voters, regardless of geography or political persuasion. Almost 90% of Americans believe that the influence of money in politics is a threat to our democracy.

A report from the Equality State Policy Center in Wyoming shows that the cost of the most expensive state legislature races there has risen to over $60,000 per candidate. This pales in comparison to 2010 spending, which averaged $5,047 for a statehouse seat and $7,347 for a state senate seat.

In Wisconsin, billionaires and out-of-state special interest groups poured $56 million into the state’s 2023 Supreme Court race, nearly four times the previous national record. This out-of-state influence is an affront to the American way of life.

This spending isn’t just a problem in Wyoming and Wisconsin. Nationally, it is anticipated that there will be $16 billion spent in this election cycle. An OpenSecrets analysis of campaign finance contribution records found dark money groups spent $615 million in 2022. This cycle, dark money groups and shell companies are on track to smash that amount.

Such spending has eroded the trust between voters and their elected officials. Indeed, 65% of Americans say they always or often feel exhausted when thinking about politics, while 55% feel angry, and only 16% trust the government. Too often, candidates and elected officials are viewed as being beholden to wealthy donors and dark money special interest groups – many of whom don’t even reside in the states where they’re exerting political influence – rather than the voters that put them into office.

How did we get here? Through decades of misguided precedent, the Supreme Court has effectively appointed itself as the legislative body for campaign finance reform, quashing the ability of states to control their own elections and creating a hyper-nationalized election spending arms race that would have shocked our Founding Fathers.

It’s a story of judicial overreach, beginning with the Supreme Court’s 1976 decision in Buckley v. Valeo. Buckley was the first decision to equate election spending with protected speech, and it fundamentally changed the balance of power and accountability, giving the wealthy donor class and dark money special interest groups more than their fair share of influence in elections. Citizens United v. FEC in 2010 made matters worse by expanding the definition of “person” in the context of political campaign finance law to include corporations and unions.

Emboldened by Supreme Court decisions, special interest groups, foreign actors, shadowy super-PACs, and profiteers are taking advantage of the dark money system by trying to maintain the status quo, skirt transparency laws, and overturn the will of the voters.

It’s no wonder that voters, Republicans and Democrats alike, list reducing the influence of money in politics as a top policy priority for 2024, just behind strengthening the economy and defending against terrorism.

Fortunately, legislators around the country are fighting back. We’re listening to our constituents and heeding their calls for change.

In Wyoming, Republican State Representative Andrew Byron supported the introduction of two committee bills focused on transparency, a burgeoning issue due to the volume of political mailers that don’t disclose who paid for them. This year, Wisconsin Republican State Representative Donna Rozar introduced a resolution urging Congress to pass an amendment to the U.S. Constitution that would restore the rights of states and Congress to set reasonable limits on campaign spending.

This is the path forward. Because of Supreme Court precedent, the only lasting solution to the corruptive influence of money in politics is through a constitutional amendment. Passing an amendment to the U.S. Constitution, such as the For Our Freedom Amendment championed by American Promise, puts the power back where it belongs: with the states. State legislatures know best how to set reasonable limits on campaign and election spending, and to stop the corruption that flows from that money. 

As state legislators, we have a responsibility to our constituents to fight for what is right and to protect their interests. We urge our fellow legislators across the country to pledge support for the For Our Freedom Amendment and to introduce resolutions in their own state houses calling on Congress to adopt the amendment.

The stakes are high, and our constituents are counting on us.

Andrew Byron is a Republican state representative in Wyoming.

Donna M. Rozar is a Republican state representative in Wisconsin. 

https://www.realclearpolitics.com/articles/2024/06/13/states_must_fight_out-of-state_influence_in_our_elections_151097.html

'Democrats May Regret Their Legal War on Trump'

 Justice is supposed to be blind. The legal jihad against anyone who ever did political business with Donald Trump has many wondering whether that’s still true. The list of Trump associates targeted by Justice Department special counsel investigations and Democratic prosecutors around the country is astonishingly long. It’s total lawfare.

The Robert Mueller investigation was supposed to uncover evidence of collusion between the 2016 Trump campaign and Russia. It found no such thing, but it did result in indictments against a roster of Trump allies and campaign officials on charges ranging from financial fraud to obstruction of justice and lying to the Federal Bureau of Investigation. Among those caught in Mr. Mueller’s web: Roger Stone, Paul Manafort, Rick Gates and Michael Flynn.

Never prosecuted? Anyone at the FBI who actually did meddle in the 2016 election.

Jack Smith’s dual mandate is to investigate Mr. Trump’s role in the Jan. 6, 2021, Capitol riot and his alleged mishandling of classified documents. In addition to three dozen felony counts against Mr. Trump, Mr. Smith has also obtained indictments against Walt Nauta, an assistant to Mr. Trump, and Carlos De Oliveira, the property manager at Mar-a-Lago. The message is clear: Even the small fish in Mr. Trump’s pond should expect to get fried.

Never indicted? Anyone associated with Secretary of State Hillary Clinton’s infamous home-brew email setup or her campaign’s cover up of its payment for the Steele dossier by falsely characterizing it as a legal fee—which, unlike Mr. Trump’s payments to Stormy Daniels, earned a civil fine from the Federal Election Commission.

In Atlanta, District Attorney Fani Willis persuaded a grand jury to indict Mr. Trump and 18 co-defendants for allegedly participating in a criminal conspiracy to alter the outcome of the 2020 election. Those charged include Trump lawyers Rudy Giuliani, John Eastman, Ray Smith III, Kenneth Chesebro and Jenna Ellis as well as Mark Meadows, a former White House chief of staff. Messrs. Giuliani and Meadows have also pleaded not guilty to similar charges brought by Kris Mayes, the Democratic attorney general of Arizona.

Michael Cohen is a hero to the left now, but in a past life federal prosecutors brought the hammer down for his work on behalf of Mr. Trump. In 2019 Mr. Cohen received a three-year prison sentence for what the judge in his case described as a “veritable smorgasbord of fraudulent conduct.” Allen Weisselberg was once chief financial officer of the Trump Organization. He is serving a five-month sentence at Rikers Island for lying under oath at the civil fraud trial brought against Mr. Trump by Democratic New York Attorney General Letitia James.

Peter Navarro, who directed the White House National Trade Council for Mr. Trump, is serving a four-month sentence in federal prison in Miami for refusal to comply with a subpoena from the Jan. 6 congressional committee. Trump whisperer Steve Bannon is headed to prison next month for the same reason.

Recall that during the Obama administration, Internal Revenue Service official Lois Lerner managed to avoid the slammer for contempt of Congress. I guess some people can’t help being lucky.

You can read the lamentably long list of Trump-world legal woes as evidence that no one is above the law, which is the view of most Democrats. Or you can read it the way half of Americans and 83% of Republicans do—as clear evidence that a politicized justice system went after Mr. Trump and his associates because of who they are. Democratic prosecutors are contorting the law beyond recognition to punish their opponents for their politics. That isn’t the American way.

Mr. Bragg campaigned on an explicit promise to prosecute Mr. Trump. His goal was to become a progressive folk hero. Ms. Willis, Ms. James and Ms. Mayes are probably hoping for the same. That alone is a problem for blind justice. But a bigger problem lurks at the heart of Mr. Bragg’s case: the idea that normal political calculations can, through prosecutorial abracadabra, become unlawful election interference.

Democrats worry about a vengeful President Trump siccing the Justice Department on his political foes in January 2025. They should perhaps be more worried about ambitious partisan prosecutors in red states going after political enemies for the novel “crime” of trying to win elections. What’s to stop a district attorney in Texas from indicting President Biden’s inner circle for conspiring to hide the commander in chief’s mental decline from the American people? Why couldn’t some ambitious Republican take a shot at prosecuting White House press secretary Karine Jean-Pierre for her daily testaments to Mr. Biden’s sprightliness? Turnabout is fair play. That actually is the American way.

If Republicans fed up with Democratic lawfare start pursuing those kinds of cases, the American legal landscape will be an ugly scene indeed. Lady Justice may wish she’d kept her blindfold on.

https://www.wsj.com/articles/democrats-may-regret-their-legal-war-on-trump-bragg-justice-new-york-eb2e54be

Scinai Eyes Conversion of its Loan to Equity

 Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) (the "Company"), a biotechnology company focused on developing inflammation and immunology (I&I) biological products and on providing CDMO services through its Scinai Bioservices business unit, today announced that it has received a non-binding Letter of Intent ("LoI") from the European Investment Bank (the "EIB"). This LoI outlines specific indicative terms for converting the EIB's loan into equity in the form of prefunded warrants, which are exercisable into American Depositary Shares ("ADSs") representing 19.5% of the fully diluted capital of the Company at the time of closing, along with a capped variable return primarily in the form of a royalty on the Company's revenues. It is important to note that the number of warrants would be fixed and without anti-dilution rights.  The amount of the loan that would be converted is approximately $27.6 million, and based on an initial, unaudited financial analysis, the Company believes that this loan to equity conversion would immediately eliminate the shareholders' deficit of $4.5 million and create an estimated shareholders equity surplus of approximately USD$14.5 million. The Company retained Deloitte to prepare a white paper analyzing the accounting impact of the loan to equity conversion. The accounting analysis is expected to be reflected in the Company's Q3 2024 financial reports. Additional details of the proposed terms are described below. The Company believes that these terms are very favorable to the Company and its shareholders, and that the substantial reduction in its long-term liabilities should improve its standing in the financial community.

As previously announced, the Company has received a Nasdaq Staff determination letter regarding noncompliance with the minimum shareholders' equity required for continued listing (under Listing Rule 5550(b)(1) or the "Rule") and that as part of the hearing previously requested with the Nasdaq Hearings Panel (the 'Hearings Panel") it would present its plan to regain and remain compliant with the Rule (the "Plan") The Company believes that the substantial reduction in long-term liabilities should not only enable it to regain compliance with the Rule but also would allow it to remain compliant for the next 12 months. The Company intends to present its Plan during its upcoming meeting with the Hearings Panel planned for June 18, 2024.  

https://www.prnewswire.com/news-releases/scinai-immunotherapeutics-announces-receipt-of-a-letter-of-intent-from-the-european-investment-bank-providing-specific-terms-for-conversion-of-its-loan-to-equity-302171862.html

UroGen 'Unprecedented' Results For Gel-Based Cancer Drug

 UroGen stock rocketed Thursday on "unprecedented" test results for its bladder cancer treatment, a gel-based drug that avoids surgically removing tumors.

After three months, 79.6% of patients treated with UroGen Pharma's (URGN) drug had a complete response, meaning evidence of their tumors disappeared. But what's unprecedented, says the company, is patients had an 82.3% chance of maintaining that response for at least a year.

Chief Executive Liz Barrett estimates that 82,000 patients live with this highly recurrent form of cancer each year in the U.S. These patients have bladder cancer that doesn't penetrate muscle tissue. Their cancer is considered intermediate risk.

https://www.investors.com/news/technology/urogen-stock-bladder-cancer-treatment/

Wells Fargo Fires Employees Over "Mouse Jigglers"

In the era of hybrid work, with employees splitting their time between two days in the office and three days working remotely, employers have ramped up using productivity monitoring software. However, employees have outsmarted some of these surveillance programs with gadgets like mouse movers, otherwise known as 'mouse jigglers.'

The popularity of mouse jigglers has exploded on TikTok in the last several years. Firms have been cracking down on these devices following a surge in fake work activity, which has weighed on productivity. 

Wells Fargo, in a new disclosure with the Financial Industry Regulatory Authority, first reported by Bloomberg, had terminated over a dozen employees in its wealth- and investment-management unit for their use of mouse jigglers.

They were "discharged after review of allegations involving simulation of keyboard activity creating the impression of active work," according to the disclosures. 

On Amazon, some of the top-ranking mouse jigglers sold have thousands of reviews and range in price between $6 and $25. 

Google Trends shows a massive search spike for these devices in 2022. 

The bank's Finra disclosure does not indicate whether the employees were fired for faking work at home or in the office. It's unclear how the employees were caught, and if the bank opted to use other forms of surveillance to catch the employees faking work. 

Major banks, including JPMorgan Chase and Goldman Sachs, were among the most aggressive institutions in ordering workers back to the office after the government enforced lockdowns. 

The jiggler is just proof of the unintended consequences of remote working. Instead of employers micromanaging their workforce with mass surveillance, perhaps implementing baseline objectives for them... 

https://www.zerohedge.com/technology/well-fargo-fires-employees-over-mouse-jigglers