What will Trump's Administration mean for Health Care ?

A thank you to Robert Pearl M.D. for his assessment of Trump's effects on Healthcare

With a new administration set to take office next week, the healthcare landscape is fraught with uncertainty as big questions abound: 

• Will Robert F. Kennedy Jr. lead HHS—and, if confirmed as secretary, will the nation’s vaccine policies see a 180-degree turn?

• How will Elon Musk’s newly formed Department of Government Efficiency (DOGE) deliver on its pledge to cut $500 billion from the budget, and what impact will it have on healthcare?

• Will Trump’s promises to tackle drug prices finally materialize, or will Congress focus on the chaos of the prior authorization process in the wake of the shocking murder of UnitedHealthcare’s CEO?

Of course, these questions aren’t just headline fodder. They’re pressing issues with big consequences for millions of Americans.

Musk’s DOGE Could Threaten The Health Of Millions Of Americans

Elon Musk, the world’s richest man, co-heads the Department of Government Efficiency, a non-government entity tasked with slashing government spending. The exact amount has been amorphous, starting with claims of cutting $2 trillion, since reduced to $1 trillion or, more modestly, “taking aim at the $500 billion-plus in annual federal expenditures that are unauthorized by Congress or being used in ways that Congress never intended.”  

Deleting Dollars From American Healthcare

Since Trump’s first term as president, the country’s economic outlook has worsened dramatically.

Back in 2016, the national debt was $19 trillion, with $430 billion spent annually on interest payments. By 2024, the debt had surged to $36 trillion, requiring $882 billion in debt service—13% of federal spending that DOGE cannot touch. 

Medicare, the $850 billion program for Americans over 65, is untouchable. So, too, is the $300 billion in tax deductibility for employer-sponsored health insurance and $120 billion in expired health programs for veterans. Cutting either involves raising taxes for 160 million working Americans or risking the health of millions of veterans.

This leaves DOGE with few options but to scale back programs that serve low-income Americans: Medicaid and online health exchanges.

Here’s how these cuts would likely unfold and the impact they would have on the lives of over 20 million Americans:

1. Reduce ACA Exchange Funding

Since the Affordable Care Act became law in 2010, it has provided insurance-premium subsidies to Americans earning 100% to 400% of the federal poverty level.

For lower-income families enrolled in the online health exchanges, the ACA also includes Cost Sharing Reductions, which help offset deductibles and co-payments. These reductions, which average 30% of total premiums, make coverage more affordable for enrollees.

Without CSRs, a family of four earning $40,000 could face deductibles as high as $5,000 before their insurance benefits take effect. The result: 7 million would drop out of the exchanges, with an estimated 4 million families becoming uninsured altogether.

If Congress allows CSR payments to expire in 2026, federal expenses could drop by approximately $35 billion annually. As millions of individuals exit the exchanges and forgo re-enrollment due to unaffordable out-of-pocket costs, DOGE could also take credit for additional savings of up to $50 billion. While these cuts may help meet budgetary targets, the human cost is undeniable: millions of low-income American families would lose health insurance.

2. Slash Medicaid Coverage, Tighten Eligibility Requirements

To achieve $500 billion in annual savings, DOGE will almost certainly target Medicaid, which provides healthcare for over 90 million low-income Americans, including children, seniors, and individuals with disabilities.

Several cost-cutting strategies are on the table, including reducing federal payments to states, tightening eligibility criteria, and restructuring Medicaid into lower-cost block grants.

Recall that the Affordable Care Act expanded Medicaid eligibility to individuals earning up to 138% of the federal poverty level. While Medicaid expansion remains optional, 40 states adopted the program, helping cut the U.S. uninsured rate in half—from 16% (50 million people) to 8% (25 million). DOGE would need Congressional approval to reverse this expansion, stripping coverage from millions in participating states.

Another possible strategy involves imposing work requirements on Medicaid recipients. While proponents argue this would spur employment, data show most Medicaid enrollees already work for employers that don’t provide insurance—or they are unable to work due to caregiving responsibilities or serious health conditions. In reality, work requirements would function primarily as bureaucratic hurdles, disqualifying or discouraging eligible individuals and driving up the uninsured rate.

Restructuring Medicaid funding into block grants is a final possibility. Unlike the current system, which adjusts funding based on need, block grants provide states with a fixed dollar amount. This would likely force states to cut services, further restrict eligibility or both. Though advocates claim block grants offer states greater flexibility, the primary result would be fewer medical services and fewer Medicaid beneficiaries.

In total, Medicaid currently costs $800 billion annually, with the federal government paying 70%. Cutting enrollment by 10% (9 million people) could save over $50 billion annually, while a 20% reduction (18 million people) could save $100 billion.

The consequences of such measures, however, would be devastating. Medicaid covers more than 40% of U.S. childbirths, ensuring healthier babies and protecting families from financial ruin. It funds routine checkups, vaccinations, and treatment for chronic conditions like asthma and diabetes for children. It also provides essential nursing home care and home health services for seniors and individuals with disabilities who cannot live independently.

But the fallout wouldn’t end with tens of millions of Americans losing healthcare coverage. If DOGE scales back Medicaid, states would be forced to absorb much of the financial burden. And since states are required to have a balanced budget, increased healthcare costs would likely lead to cuts in education funding, reduced infrastructure investments and the closure of community hospitals—many of which are already struggling to stay afloat—further straining local economies and leaving patients with nowhere to turn.

The First 100 Days

The numbers don’t lie: If DOGE is going to achieve Musk’s $500 billion pledge, it would have to slash Medicaid funding and ACA subsidies to reach its cost-cutting goal in year one.

Yet, this approach isn’t the only path to fiscal responsibility. There are long-term healthcare solutions that could reduce medical spending while preserving the nation’s health. These would require bold, systemic reforms but they are achievable.

They include shifting how doctors and hospitals are paid to reward superior clinical outcomes instead of higher volumes, capping drug prices at levels comparable to peer nations, and deploying generative AI to prevent and manage chronic diseases more effectively.

These strategies would drive down costs by improving quality and preventing heart attacks, strokes and kidney failure, not by rationing care. Unfortunately, neither Musk nor DOGE has championed these ideas.

For now, the healthcare of tens of millions of Americans hangs in the balance, seemingly collateral damage in politically and financially.

What a health insurance CEO's murder reveals about America's pain.

The murder of UnitedHealthcare CEO Brian Thompson represented a horrific and indefensible act of violence. His family deserves our deepest sympathy.

As a physician and healthcare leader, I initially declined to comment on the killing. I felt that speculating about the shooter's intent would only sensationalize a terrible act.

Regardless of the circumstances, vigilante violence has no place in a free and just society.

But now, more than a month later, I feel compelled to address one aspect of the story that has been widely misunderstood: the public's reaction to the news of Thompson's murder. Specifically, why tens of thousands of individuals "liked" and "laughed" at a post on Facebook announcing the CEO's death.  

What causes someone to ‘like' murder?

News analysts have attributed the social media response to America's "simmering anger" and "frustration" with a broken healthcare system, pointing to rising medical costs, insurance red tape, and time-consuming prior authorization requirements as justifications.

These are all, indeed, problems and may explain some of the public's reactions. Yet these descriptions grossly understate the lived reality for most of those affected. When I speak with individuals who have lost a child, parent, or spouse because of what they perceive as an unresponsive and uncaring system, their pain is raw and intense. What they feel isn't frustration-it's agony.  By framing healthcare's failures in terms of statistical measures and policy snafus, we reduce a deeply personal crisis to an intellectual exercise. And it's this very detached, cognitive approach that has allowed our nation to disregard the emotional devastation endured by millions of patients and their families.

When journalists, healthcare leaders, and policymakers cite eye-popping statistics on healthcare expenditures, highlight exorbitant insurer profits, or deride the bloated salaries of executives, they leave out a vital part of the story. They omit the unbearable human suffering behind the numbers. And I fear that until we approach healthcare as a moral crisis-not merely an economic or political puzzle to solve nation will never act with the urgency required to relieve people's profound pain.  As a clinician, I've seen life-destroying pain in my patients and even within my own family. When my cousin Alan died in his twenties from a then-incurable cancer, my aunt and uncle were powerless to save him. Their grief was profound, unrelenting, and eternal. They never recovered from the loss. But Alan's death, heartbreaking as it was, stemmed from the limits of science at the time.

What millions of Americans endure today is different. Their loved ones die not because cures don't exist but because the healthcare system treats them like a number. Bureaucratic inefficiencies, profit-driven delays, and systemic indifference produce avoidable tragedies.

To appreciate this depth of pain, imagine standing behind a chain-link fence, watching someone you love being tortured. You scream and plead for help, but no one listens. That is what healthcare feels like for too many Americans. And until all of us acknowledge and feel their pain, little will improve.

Curing America's indifference

When we focus solely on cold numbers millions who've lost Medicaid coverage, the hundreds of thousands of avoidable deaths each year, or the life-expectancy gap between the U.S. and other nations-we strip healthcare of its humanity.

But once we stop framing these failures as bureaucratic inefficiencies or frustrations and, instead, focus on the devastation of having to watch a loved one suffer and die needlessly, we are forced to confront a moral imperative. Either we must act with urgency and resolve the problem or admit we simply don't care.

In the halls of Congress, lawmakers continue to weigh modest reforms to prior authorization requirements and Medicaid spending steps that won't fix a system in crisis. The truth is that without bold, transformative action, healthcare will remain unaffordable and inaccessible for millions of families whose anguish will grow. Here are three examples of the scale of transformation required:

1. Reverse the obesity epidemic with a two-part strategy. Congress must tax ultra-processed, sugary foods that drive hundreds of billions of dollars in healthcare costs yearly. In parallel, lawmakers should cap the manufacturer-set price of weight-loss medications like Ozempic and Wegovy to be no higher than in peer nations.
2. Change clinician payments from volume to value. Current fee-for-service payment systems incentivize unnecessary tests, treatments, and procedures rather than better health outcomes. Transitioning to pay-for-value would reward healthcare providers, specifically primary care physicians, who successfully prevent chronic diseases, better manage existing conditions, and reduce complications such as heart attacks, strokes, and kidney failure.
3. Empower patients and save lives with generative AI. Tools like ChatGPT can help reduce the staggering 400,000 annual deaths from misdiagnoses and 250,000 more from preventable medical errors. Integrating AI into healthcare enables at-home care, continuous disease monitoring, and personalized treatment, making medical care safer, more accessible, and more efficient.

If elected officials, payers, and regulators fail to act, they will have chosen to perpetuate the unbearable pain and suffering patients and families endure daily. They need to hear people's cries. The time for transformative action is now.

One of his cabinet appointments is Robert F.  Kennedy, Jr.  a controversial figure who advocated healthy living and who raised serious questions about the number of vaccinations mandated for children (20).

A.I or artificial intelligence is being bandied about promising a revolution in diagnosis and enhancing physicians' work.  Trump is proposing a "STARGATE" venture to promote the funding of artificial intelligence harnessing the use of clean energy. Three top tech firms on Tuesday announced that they will create a new company, called Stargate, to grow artificial intelligence infrastructure in the United States.

OpenAI CEO Sam Altm S OpenAI CEO Sam Altman, SoftBank CEO Masayoshi Son and Oracle Chairman Larry Ellison appeared at the White House Tuesday afternoon alongside President Donald Trump to announce the comTrump called the “largest AI infrastructure project in history.”

The companies will invest $100 billion in the project to start, with plans to pour up to $500 billion into Stargate in the coming years. The project is expected to create 100,000 US jobs, Trump said.

Stargate will build “the physical and virtual infrastructure to power the next generation of AI,” including data centers around the country, Trump said.

HELPFUL LINKS

• How RFK Jr. Could Reverse Our Nation’s Illogical Approach To Obesity (Forbes)
• Healthcare’s Cost Crisis: How Primary Care Can Deliver The Savings We Need (Forbes)
• 3 Simple Questions To Separate AI Reality From Hype In Medicine (Forbes)

 https://app.flashissue.com/newsletters/f775ef5e1ef96c424df98621d24d97f86989c9bd

DOJ secured $1.7B from healthcare False Claims settlements, judgments in 2024

 The Department of Justice (DOJ) recouped more than $2.9 billion for the federal government from False Claims Act settlements and judgments during the 2024 fiscal year, with nearly $1.7 billion of the total related to healthcare.

Those tallies, announced Wednesday, included the highest-ever number of whistleblower cases in a single year—979 filings that contributed to $2.4 billion of the total and put more than $400 million into the whistleblowers’ pockets. 

The top-line number outpaces fiscal 2023’s $2.7 billion, though the healthcare tally is slightly below that year’s over $1.8 billion related to healthcare. Fiscal 2021 remains the most lucrative year for False Claims settlements and judgments, with more than $5 billion. 

“The False Claims Act and its whistleblower provisions remain a critical tool in protecting the public fisc and ensuring that taxpayer funds serve the purposes for which they were intended,” Principal Deputy Associate Attorney General Benjamin Mizer said in a statement.

False Claims Act recoveries help restore funds to federal healthcare programs including Medicare, Medicaid and TRICARE, the DOJ said. The $1.7 billion of healthcare recoveries only relates to federal losses, “but in many of these cases, the Department was instrumental in recovering additional amounts for state Medicaid programs,” it said.  

The department’s announcement put a spotlight on settlements and recoveries related to companies and individuals who it said contributed to the country’s opioid epidemic, delivered unnecessary services and substandard care, took advantage of the Medicare Advantage program, paid out unlawful kickbacks for services and committed other types of healthcare fraud.

More than two dozen such examples were highlighted in the release.

Rite Aid Corporation and several of its affiliates, for instance, paid $7.5 million and agreed to provide an allowed, unsubordinated, general unsecured claim of $401.8 million in its bankruptcy case to resolve allegations it knowingly improperly dispensed prescriptions for controlled substances. Drug manufacturer Endo Health Solutions, which is currently in bankruptcy, also agreed to a $475.6 million claim over allegations that it aggressively marketed an opioid to high-volume prescribers.

Beyond opioids, Rite Aid and its subsidiaries were named a second time in the release for a $121 million settlement tied to inaccurately reporting drug rebates to Medicare.

Several healthcare providers were listed among the highlighted cases as well. Among the larger recoveries were $345 million from Community Health Network in a settlement related to services referred in violation of the Stark Law.

CVS Health’s primary care affiliate Oak Street Health paid the government $60 million to resolve allegations of kickback payments to third-party insurance agents in exchange for recruiting seniors to its clinics. Dialysis care company DaVita agreed to a $34.5 million payment over allegations of kickbacks to a competitor to induce referrals, while behavioral health care provider Acadia Healthcare Company paid $16.6 million over alleged billing for unnecessary services, improper discharges, and staffing shortcomings.

The DOJ also noted a $106.8 million settlement with Walgreens related to allegations of billing government programs for prescriptions that were processed and never picked up.

On the year’s Medicare Advantage investigations, the department added that it has continued to litigate “several other cases involving the Medicare Advantage program, including actions against UnitedHealth Group, Elevance Health (formerly Anthem), and the Kaiser Permanente consortium.”

The top-line number outpaces fiscal 2023’s $2.7 billion, though the healthcare tally is slightly below that year’s over $1.8 billion related to healthcare. Fiscal 2021 remains the most lucrative year for False Claims settlements and judgments, with more than $5 billion. (Year of the COVID-19 Pandemic)

"As we look ahead to the new administration, it’s noteworthy that the first Trump administration saw almost 370 more healthcare [False Claims Act] cases brought by relators than those filed during the Biden administration," he continued. "The first Trump administration also saw the highest number of healthcare-related [False Claims Act] cases brought in a single year by the Department of Justice. As people consider the potential enforcement climate for healthcare companies in 'Trump 2,' history may provide some interesting guidance."

There are many conflicting measures of the cost-effectiveness of Advantage Health Plans.  The details are buried in the muck.

OIG Report

 

https://www.fiercehealthcare.com/ai-and-machine-learning/doj-secured-17b-healthcare-false-claims-settlements-judgments-during-fy24

What is Medical Malpractice ?

 

Medical malpractice occurs when a doctor, hospital or other health care provider harms a patient by neglecting to follow the recognized standard of care. The negligence might be the result of errors in diagnosis, treatment, aftercare or health management. Clear, two–way conversation is a key element in preventing malpractice claims

- Hospital-acquired infection.
- Improper use of anesthesia.
- Failure to treat an illness.
- Improper administration of drugs
-Failure in order proper tests.
- IN correct treatment of a diagnosed illness.

- Failure to consult with a specialist

Failure to consult with a specialist
- Failure to monitor a patient
- Failure to stabilize a patient.
- Improper use of a medical device
- Birth injury or birth trauma due to physician, nursing or hospital negligence.
-Surgical procedures that are done without patient consent.
- not enough knowledge or interest in the treatment of patients, superficially care
- lack of compassion and respect for the life saving, facilitating the incoming money with less care of the patient and pushing to free the beds to be available in the unit

Risk management to avoid malpractice: 40-60% of all medical malpractice claims are avoidable with systemic risk management. Utilizing risk management allows a business to identify and correct potential risks before they cause an issue for the company.
🔅 Risk compliance reduces medical errors through protocols that prevent and mitigate mistakes. It ensures that all team members are aware of possible risks and know how to handle them. Risk management solutions help organizations get to the root of errors and failures to prevent future occurrences rather than coming up with a one-time fix for the problems and hoping they go away.
There are several hazards that medical employees and risk managers must be aware of on top of common health-related claims like medical malpractice and medical error.

FDA Bans Food Coloring Red Die #3 from Ingested Products

  January 15, 2025

The FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is amending its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 color additive petition. The petition requested the agency review whether the Delaney Clause applied and cited, among other data and information, two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat-specific hormonal mechanism. The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and ingested drugs puts people at risk are not supported by the available scientific information. 

FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. The FDA estimates that FD&C Red No. 3 is not as widely used in food and drugs when compared to other certified colors based on information available in third-party food product labeling databases, food manufacturers’ websites and other public information, and the FDA’s certification data. FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs. 

Manufacturers who use FD&C Red No. 3 in food and ingested drugs will have until January 15, 2027, or January 18, 2028, respectively, to reformulate their products. Other countries still currently allow for certain uses of FD&C Red No. 3 (called erythrosine in other countries). However, foods imported to the U.S. must comply with U.S. requirements.

Enforcement of the new law came swiftly. Within two months of the passage of the act, the FDA began to identify drugs such as the sulfas that simply could not be labeled for safe use directly by the patient--they would require a prescription from a physician. The ensuing debate by the FDA, industry, and health practitioners over what constituted a prescription and an over-the-counter drug was resolved in the Durham-Humphrey Amendment of 1951. From the 1940s to the 1960s, the abuse of amphetamines and barbiturates required more regulatory effort by the FDA than all other drug problems combined. Furthermore, the new law ushered in a flood of new drug applications, over 6,000 in the first nine years, and 13,000 by 1962.

A new drug law in that year, the Kefauver-Harris Amendments, derived in large part from hearings held by Senator Estes Kefauver. As with the 1938 act, a therapeutic disaster compelled the passage of the new law; in this case, the disaster was narrowly averted. Thalidomide, a sedative that was never approved in this country, produced thousands of grossly deformed newborns outside of the United States. The new law mandated efficacy as well as a safety before a drug could be marketed required the FDA to assess the efficacy of all drugs introduced since 1938, instituted stricter agency control over drug trials (including a requirement that patients involved must give their informed consent), transferred from the Federal Trade Commission to the FDA regulation of prescription drug advertising, established good manufacturing practices by the drug industry, and granted the FDA greater powers to access company production and control records to verify those practices. Three years later Congress gave the FDA enhanced control over amphetamines, barbiturates, hallucinogens, and other drugs of considerable abuse potential in the Drug Abuse Control Amendments of 1965. That function was consolidated with similar responsibilities in 1968 under an organization that gave rise to the Drug Enforcement Administration.

The first food standards to be issued under the 1938 act were for canned tomato products; by the 1960s about half of the food supply was subject to a standard. As food technology changed and the number of possible ingredients--including fortifying nutrients--grew, the agency developed recipe standards for foods, and lists of ingredients that could lawfully be included in a product. A food that varied from the recipe would have to be labeled an imitation. 

Following hearings in the early 1950s under Representative James Delaney, a series of laws addressing pesticide residues (1954), food additives (1958), and color additives (1960) gave the FDA much tighter control over the growing list of chemicals entering the food supply, putting the onus on manufacturers to establish their safety. While tolerances could be established for many chemicals, a provision of the 1958 law, the Delaney Clause, banned any carcinogenic additive.

FDA pursued numerous cases of food misbranding in the 1950s and 1960s, most deriving from false nutritional claims and unscientific enrichment, with mixed success in the courts. In 1973, following hearings the agency convened to address the vitamin fortification of foods and the claims made for dietary supplements, the FDA issued regulations for special dietary foods, including vitamins and minerals. The public response to these regulations helped lead Congress in 1976 to prohibit the FDA from controlling the potency of dietary supplements, although the agency maintained the authority to regulate enriched foods.

The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals. This is not the first time the agency has revoked an authorization based on the Delaney Clause. For example, in 2018, the FDA revoked authorization for certain synthetic flavors

The Future Of Hospitals -

The COVID pandemic has revealed the fragility of healthcare systems and how clinics and hospitals were completely unprepared for the crisis. However, this is just part of a bigger problem. In many ways, healthcare facilities are still stuck in the 20th century and are long overdue for a top-to-bottom overhaul with digital health leading the way

Future improvements can occur with a radical rethinking of hospital designs. Patient-friendly rooms allow for mobility and some in-room physical therapy. Environmentally appealing rooms with art, sculpture, and botanical displays. Lifelike trees, plants, and flowers are easily obtainable. Think in terms of a small studio apartment.

Placing mildly or moderately ill patients in a bed is in itself disabling and leads to further deterioration, especially in the aged and chronically ill. It has been shown that even a brief hospitalization for two or three days harms the human body.

The use of artificial intelligence to monitor patients could do away with many needless alarms (heart rate, EKG, IV infusion alarms at the bedside. The constant alarm sounds disrupt sleep endlessly. It is a fact that most alarms are only heard by the patient, and ignored at the nurse's station due to burnout and fatigue.

Telehealth allows the bifurcation of patient care for the less ill using patient-centered care at home, while allowing the limited availability of hospital beds for acutely ill patients. This was proven to work well during the pandemic.