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Thursday, April 10, 2025

Medicaid Needs Commonsense, Cost-Saving Reforms

 Almost as soon as the U.S. House of Representatives unveiled its budget resolution in February, which envisioned saving hundreds of billions of dollars in projected Medicaid spending, political opportunists pounced, accusing lawmakers of heartlessly targeting the vital health benefits of poor people. A typical article in The Washington Post warned of grave substantive and political consequences, saying that the proposed “cuts” “could devastate America’s teetering rural health-care system and jeopardize Republicans’ political power among rural voters.”

These hyperbolic assertions are typical of what happens whenever lawmakers make a serious effort to deal with the federal government’s unsustainable fiscal situation. The attacks may be politically effective, but they are substantively wrong. Slowing Medicaid’s cost growth is a policy imperative, and there are many ways to do so that would actually strengthen the program’s capacity to serve needy populations.

Reasons for Reform

Some brief background is necessary to understand the issues in play. Medicaid is a joint state and federal program providing health insurance to low-income Americans. Historically, the program has long served vulnerable populations such as impoverished pregnant women and children, as well as parents, aged individuals and disabled adults who qualify for federal income assistance. The costs of covering these populations are split between the federal government and state governments, with the federal government historically providing somewhat more than half the funding.

In 2010, federal lawmakers dramatically expanded Medicaid as part of the Affordable Care Act (ACA), an expansion later rendered optional for the states by a Supreme Court decision. The expansion allowed states to cover nonaged, nondisabled adults with incomes above the federal poverty level—and, importantly, the federal government initially covered 100% of these costs, phasing down gradually to 90%. The expansion has precipitated several adverse policy consequences, as this piece will explain.

There are several reasons why Medicaid must be reformed to slow its cost growth. For starters, there is no choice in the matter: The rate of Medicaid cost growth, currently occurring on autopilot under existing law, exceeds our rate of national economic growth. This can’t go on forever, which means the question is not whether to slow Medicaid’s cost growth but how. The American public is ill-served by mischaracterizations suggesting that slowing Medicaid growth is optional, contemplated only by lawmakers harboring an ideological hostility to the program or to low-income people. An honest debate would recognize that Medicaid cost growth must be slowed and would focus on comparing alternatives for doing so.

Medicaid isn’t the only area of the federal budget where cost-saving reforms are needed, but it’s one of the biggest. I maintain a recurring analysis of federal budget deficits that I update every few years, and the most recent (2021) version showed that Medicaid and the ACA account for roughly 22% of emergent federal deficits. This means that these programs contribute more to the federal fiscal imbalance than anything else besides Medicare. Medicare, Medicaid and the ACA together account for over two-thirds of our worsening fiscal problem, while all other areas of tax and spending policy combined add up to less than one-third. Slowing Medicaid cost growth is not an option, it’s a requirement.

Beyond the need to save money, Medicaid reforms are also warranted in the interests of maintaining the program’s integrity and serving its beneficiaries. A fundamental problem exists at the heart of Medicaid’s design: States make the decisions on whom Medicaid should cover but pass off the majority of costs to the federal government. This distorts states’ incentives away from prudent fiscal stewardship toward maximizing their collection of federal dollars. This problem is greatest with respect to those added to Medicaid due to the ACA’s expansion, for whom the federal government currently pays 90% of states’ coverage costs.

On its face, it is unjust that the federal government’s reimbursement rate for the ACA’s expansion population is so much higher than its rate for Medicaid’s previously eligible population. There is no health policy reason why the federal government should pay far more of the costs of covering a higher-income, nonaged, able-bodied, childless adult than it does for covering a pregnant woman living in poverty. The only reason these grossly unequal reimbursement rates were ever established was to induce reluctant states to expand Medicaid per the terms of the ACA. Purely as a matter of fairness, this difference in rates should not persist.

Beyond the principle at stake, the evidence shows real-world adverse consequences of the ACA’s inflated expansion match rate. Before the ACA, the supply of Medicaid services was already less than the demand from Medicaid patients, in part because many healthcare providers do not accept Medicaid. When the ACA dramatically expanded the number of Medicaid patients competing for access, there was no corresponding increase in the number of Medicaid providers, which meant something had to give. Economist Liam Sigaud and I discovered in a 2022 study that expansion states had shifted Medicaid’s financial resources away from low-income children toward higher-income, able-bodied adults. Specifically, we found that “states that expanded Medicaid ... spent only 5.9% more per capita on children in FY 2019 than they did in FY 2013 compared with growth of 22.7% in per capita spending on children in nonexpansion states and of 27.0% in average healthcare spending per capita for the US population as a whole.”

How To Lower Costs

The realities of the ACA’s Medicaid expansion render ironic some of the attacks on proposals to address Medicaid spending growth. It’s incorrect to assume that more spending on Medicaid is always good for Medicaid patients, especially when spending on higher-income individuals causes program resources to be shifted away from needier patients. One of the best things lawmakers could do for long-time Medicaid beneficiaries is to ensure states aren’t getting greater financial rewards for covering better-off beneficiaries, who end up competing for access with more vulnerable beneficiaries, for whom less support is provided.

Parity between Medicaid participants would be most readily accomplished by equalizing reimbursement rates for all participants at pre-ACA levels. Brian Blase and Drew Gonshorowski of the Paragon Health Institute have estimated that equalizing reimbursement rates and moving those above the poverty line out of Medicaid and onto the ACA’s health exchanges would save the federal government more than $250 billion over 10 years. And that’s before assuming any behavioral changes by states or individuals that would likely lower federal costs even further.

Other things can and should be done to lower federal Medicaid costs without harming beneficiaries. One is to crack down on provider taxes, which are essentially a gimmick employed by states to shake more dollars out of Washington. Suppose, for example, that the federal government has promised to cover 60 cents of every dollar a state spends on Medicaid. A state can inflate its take by spending more—say, $1.50 instead of $1, thereby boosting federal support from 60 cents to 90 cents—and then recouping the extra 50 cents of spending from providers via a “provider tax.” This gimmick doesn’t help beneficiaries in any way, because the net amount given to health providers is the same. All that it accomplishes is to inflate federal Medicaid spending.

The skewed incentives arising from the federal government paying for the majority of states’ Medicaid coverage decisions are incompatible with prudent fiscal stewardship. This has always been a problem, but improper payments have metastasized since the ACA expanded Medicaid, as Paragon’s Blase and economist Rachel Greszler have shown. Medicaid reported more than $500 billion in improper payments over the most recent decade, but this measurement was limited by the rarity of eligibility review audits, which occurred in only two out of the past 10 years. Blase and Greszler found that if the error rates found during years of eligibility reviews also occurred in years such reviews were lacking, total improper payments might well have exceeded $1 trillion.

Excess payments can result from many causes, including misclassifications of individuals into categories that trigger higher federal reimbursement rates. For example, the ACA established higher federal reimbursement rates for covering nondisabled adults than disabled ones. In our 2022 study, Sigaud and I also found that expansion states were reporting a decline in the number of disabled beneficiaries, a mysterious result given that there was no similar decline in nonexpansion states. This reported decline in disabled beneficiaries coincided with expanded coverage of adults not described as disabled—for whom, notably, states received far more generous federal funding support. Regardless of the cause, correcting improper and excess payments is the right thing to do, in addition to producing cost savings.

Lawmakers should be applauded rather than demonized for confronting the rising costs of Medicaid. Whereas arbitrary, across-the-board cuts could be harmful to beneficiaries, the right cost-saving reforms will help them. Such reforms should include normalizing federal reimbursement rates, cracking down on provider taxes and other gimmicks and correcting improper payments.


Charles Blahous holds the J. Fish and Lillian F. Smith Chair at the Mercatus Center, and previously served as a public trustee for Social Security and Medicare as well as Deputy Director of the National Economic Council.


https://www.discoursemagazine.com/p/medicaid-needs-commonsense-cost-saving

To end illegal immigration, don’t fix the asylum system — abolish it

 Joe Biden’s border crisis is over. It didn’t take new laws, just a new president.

But it’s only a temporary reprieve. What happens next time we get a president — as we will — with Biden’s border philosophy?

Nothing can completely Biden-proof the border (as it were). But one important change would make it much harder for a President Jasmine Crockett or President Gavin Newsom to illegally usher in millions more illegal aliens.

End asylum.

After all, the Democrats’ rationale for admitting all those millions of illegal border-crossers was that they had a “right” to claim asylum, the legal protections offered to political or religious refugees.

Many never even bothered to apply, but those who did produced an immigration-court backlog that may never be cleared.

That means these illegal-alien applicants will get to stay (and work) here “legally” for years before their hearing dates arrive — having kids, buying homes, putting down roots.

And when they lose, as most will, how are we supposed to find and remove them?

A new Heritage Foundation report laid out several important ways to reform and restrict asylum.

Such changes would be great first steps, but they don’t go nearly far enough.

Asylum needs to be abolished altogether.

Current asylum law was invented in 1951 to deal with the fallout of World War II and the Soviet takeover of Eastern Europe.

Three-quarters of a century later, it’s an anachronism, a Cold War relic out of place in today’s very different world.

Unlike refugee resettlement, which countries affirmatively choose to do (wisely or not), asylum represents a surrender of national sovereignty.

Instead of a country’s government deciding to bring in refugees, asylum means the illegal alien gets to decide, by claiming the legal right to stay in the country he has infiltrated — whether that country’s people like it or not.

When asylum involved the defection of a handful of Russian ballerinas, that surrender of national sovereignty was not a big deal.

But today, the USSR no longer exists. “Developing nations” are no longer ruled as European colonies, and their populations have exploded. Transportation and communication is cheaper than ever.

All that means asylum has morphed from a way of protecting individuals facing persecution into a vehicle for mass, nation-breaking illegal immigration.

Ending asylum in the United States will first require our withdrawal from the United Nations framework known as the 1951 Refugee Convention and the 1967 Protocol.

To do so, President Donald Trump can simply give the UN Secretary-General one year’s notice — a move that the White House considered during Trump’s first term, but never followed through on.

But that alone won’t be enough: Congress must also amend the 1980 Refugee Act, which incorporated the UN treaties’ asylum provisions into US law.

The revised measure can eliminate any opportunity for an illegal alien to stay under any circumstances, by dismantling the asylum pipeline entirely.

A person who infiltrates the US border or overstays a visa and claims a fear of returning home to avoid deportation should have no right to remain.

Instead, anyone claiming fear of return should automatically be sent to a third country with which we’ve made arrangements.

Any illegal immigrant genuinely fleeing persecution will be grateful for sanctuary anywhere — any port in a storm.

But since claims of asylum are almost always bogus, that circumstance should be vanishingly rare.

This plan differs from the Remain in Mexico policy developed during the first Trump term and restarted in the second.

Under that arrangement, illegal immigrants still get to apply for asylum in the US, but are sent back across the border to await their hearing dates.

It’s a useful stopgap, but only that — because the ability to apply for asylum at all is the magnet drawing illegal migrants.

In fact, the Trump administration is already in talks with a number of countries to take in deportees  whose home nations won’t take them back.

Applying that model to “asylum seekers” would be expensive at first, since we’d have to cover the host countries’ costs.

But once it became clear that shouting “Asylum!” was no longer the golden ticket to America but instead to Mongolia or Burundi, wannabe illegal aliens would look elsewhere.

Congress can adopt other measures, too, to keep a President Crockett or Newsom from reprising Biden’s border-busting.

Legislation should curb immigration parole, bar any president from giving work permits to illegals, and cap the number of appeals allowed in immigration-court cases.

But ending asylum would be the single most effective measure to limit illegal immigration now — and to take away the left’s most powerful tool in its never-ending crusade to erase America’s borders.

Mark Krikorian is executive director of the Center for Immigration Studies.

https://nypost.com/2025/04/10/opinion/dont-fix-the-us-asylum-system-shut-it-down-for-good/

US FDA to phase out animal testing in drug development

 The U.S. Food and Drug Administration said on Thursday it plans to replace animal testing in the development of monoclonal antibody therapies and other drugs with "human-relevant methods," including the use of AI-based models.

The new approach would help improve drug safety, lower research and development costs and drug prices, the agency said.

"This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use," said FDA Commissioner Martin Makary.

The FDA’s animal testing requirement will be "reduced, refined, or potentially replaced" with so-called New Approach Methodologies, or NAMs data, which include the use of AI-based models to predict a drug’s behavior as well as side effects and testing on human organ-like structures made in a laboratory.

"There is currently no full replacement for animal models in biomedical research and drug development," the National Association for Biomedical Research (NABR) said in a statement.

While AI promises to speed up many aspects of research, it largely depends on pulling from existing data, said NABR President Matthew Bailey.

"The unknown variables could present the biggest risk to patients. So, it will be interesting to see where AI is validated as a replacement to a whole biological organism and where it isn’t," Bailey said.

The FDA said it will begin implementation of the new approach immediately, encouraging NAMs data instead of animal data for human trial applications.

The companies that submit strong safety data from non-animal tests may receive a streamlined review, which would incentivize investment in modern testing platforms, the regulator said.

The agency plans to launch a pilot program, over the next year allowing select antibody-based drug developers to use a non-animal-based testing strategy. The findings from an accompanying pilot study would then be used to decide broader policy changes and guidance updates, which are expected to be rolled out in phases.

https://www.investing.com/news/general-news/us-fda-to-phase-out-animal-testing-in-drug-development-3980150

Idaho Governor Signs Bill Banning Businesses, Schools From Requiring Medical Procedures

 by Zachary Stieber via The Epoch Times (emphasis ours),

Idaho Gov. Brad Little has signed legislation that bans businesses and schools from requiring customers, employees, and students to receive vaccines or other medical procedures.

Idaho Gov. Brad Little speaks at the White House on July 16, 2020. Jim Watson/AFP via Getty Images

On April 4, Little signed the Idaho Medical Freedom Act, or Senate Bill 1210.

The act states, in part, that a business “shall not refuse to provide any service, product, admission to a venue, or transportation to a person because that person has or has not received or used a medical intervention.”

It states that a school “shall not mandate a medical intervention for any person to attend, enter campus or buildings, or be employed.” It also states that, unless required by federal law, state, county, and local governments cannot require a person to receive a medical intervention.

A medical intervention is defined in the legislation as “a medical procedure, treatment, device, drug, injection, medication, or medical action taken to diagnose, prevent, or cure a disease or alter the health or biological function of a person.”

State Rep. Rob Beiswenger, a Republican who co-sponsored the bill, wrote on social media platform X after the signing, “Idaho has the best health freedom laws in the country!”

State Rep. Todd Achilles, a Democrat, was one of the bill’s opponents. Speaking on the floor of the Idaho House of Representatives before the chamber passed the act, he said that the updated legislation, despite amendments, “remains deeply flawed,” partly because its definition of medical intervention is “overly broad.”

Effectively, what this bill does is it ties the hands of Idaho businesses, who have the duty to protect their customers and their employees,” he said. “We’re telling them what they can and can’t do.”

Little, a Republican, had vetoed Senate Bill 1023, which contained similar language. He said that Senate Bill 1023 would remove “parents’ freedom to ensure their children stay healthy at school because it [would jeopardize] the ability of schools to send home sick students with highly contagious conditions.”

Senate Bill 1210, the bill that was signed into law, expanded on the section relating to schools by giving them the ability to prevent sick children from going to class.

It took some twists and turns, but the Medical Freedom Act passed the Legislature just before adjournment, and this time, the governor has signed it,” the Idaho Republican Party said on Facebook.

Leslie Manookian, president and founder of Health Freedom Defense Fund, helped lawmakers craft the legislation. She welcomed the signing of the bill.

“Medical freedom is a basic and fundamental human right, and the Idaho Medical Freedom Act sets a powerful precedent not only for our state but for the entire country,” she said in a statement.

https://www.zerohedge.com/political/idaho-governor-signs-bill-banning-businesses-schools-requiring-medical-procedures

CeriBell's IPO Lockup Ended April 9

 CBLL's lockup expiration on April 9th could impact share prices.

https://seekingalpha.com/article/4773498-ceribell-s-ipo-lockup-ends-april-9-here-s-why-we-re-shorting-it-today

Inotiv and Charles River stock tumble as FDA moves away from animal testing

 Shares of Inotiv (NASDAQ:NOTV) and Charles River Laboratories (NYSE:CRL) plummeted 49.5% and 28.1% respectively in today’s trading session. The steep decline comes on the heels of a landmark announcement from the U.S. Food and Drug Administration (FDA), which is set to significantly reduce the reliance on animal testing for drug development.

The FDA’s groundbreaking initiative is designed to replace animal testing with more effective, human-relevant methods in the development of monoclonal antibody therapies and other drugs. This move is expected to not only improve drug safety and expedite the evaluation process but also to cut down on research and development costs and potentially lower drug prices.

According to the FDA, the agency will begin to encourage the inclusion of New Approach Methodologies (NAMs) data in investigational new drug applications. The use of AI-based computational models and organoid toxicity testing in a laboratory setting is among the alternatives proposed to reduce, refine, or replace animal testing. Additionally, the FDA plans to utilize real-world safety data from other countries with comparable regulatory standards to make determinations of efficacy.

FDA Commissioner Martin A. Makary, M.D., M.P.H., expressed the significance of this shift, stating, "For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use."

The FDA’s approach includes promoting advanced computer simulations and human-based lab models, such as organoids and organ-on-a-chip systems, to test drug safety. These methods are expected to reveal toxic effects that might go undetected in animals, offering a more direct insight into human responses. The agency also aims to provide regulatory incentives for companies that submit strong safety data from non-animal tests, which may lead to streamlined reviews.

This policy change is anticipated to speed up the drug development process, allowing therapies to reach patients quicker without compromising safety. It also aligns with the FDA’s commitment to modernize regulatory science as technology advances.

The FDA’s announcement represents a shift in the regulatory landscape that could have profound implications for companies like Inotiv and Charles River Laboratories, which have traditionally provided animal testing services to the pharmaceutical industry. The market’s reaction reflects the potential impact on these companies’ business models, as investors reassess the long-term demand for animal testing in light of the FDA’s new direction.

https://www.investing.com/news/stock-market-news/inotiv-and-charles-river-stock-tumble-as-fda-moves-away-from-animal-testing-93CH-3980230

US FDA approves syringe version of Argenx's immune disorder drug

 

  • VYVGART, the first-in-class FcRn blocker, now offers three administration options, including self-injection with a prefilled syringe
  • Self-injection provides gMG and CIDP patients with flexibility for when and where to receive treatment – at home, while ‘on the go’ or in a healthcare setting
  • Approval reflects commitment to innovating the patient experience with individualized, safe and effective therapies

argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) approved a new option for patients to self-inject VYVGART® Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

“Today’s FDA approval provides a new self-injection option across both approved indications in the U.S. that is designed for patients who seek more independence with their treatment,” said Luc Truyen M.D., Ph.D., Chief Medical Officer, argenx. “We understand patients experience MG and CIDP in different ways, and our prefilled syringe is an important innovation that provides patients with more freedom and flexibility to self-administer VYVGART Hytrulo. Whether patients prefer to receive their treatment in a physician’s office, at home, or while traveling, they can experience treatment on their own terms and continue to benefit from VYVGART Hytrulo’s favorable safety profile and strong efficacy.”

VYVGART Hytrulo prefilled syringe for self-injection is approved as a 20-to-30-second subcutaneous injection administered by a patient, caregiver, or healthcare professional. Patients are able to self-inject after proper instruction in subcutaneous injection technique. The single dose prefilled subcutaneous injection was developed as part of argenx’s exclusive partnership with Halozyme’s ENHANZE® drug delivery technology, which enables rapid, high-volume delivery of biologics.

https://www.morningstar.com/news/globe-newswire/1001079716/argenx-announces-fda-approval-of-vyvgart-hytrulo-prefilled-syringe-for-self-injection-in-generalized-myasthenia-gravis-and-chronic-inflammatory-demyelinating-polyneuropathy