RealClearHealth Articles
The Semaglutide Shortage Is Over and So Is the Excuse
A drug shortage is a public-health emergency. It is not a corporate growth strategy.
That distinction, obvious to almost everyone except the expanding mass-compounding industry, received some welcome reinforcement from the U.S. Court of Appeals for the Fifth Circuit. On August 27, the court upheld the Food and Drug Administration's determination that the shortage of Novo Nordisk's semaglutide injection products, Ozempic and Wegovy, had ended. The compounders challenged the agency. They lost.
Good. The issue was never whether compounding has a legitimate role in American medicine. Of course it...
CMS Is Reining in 340B Program Abuse – Rural Patients Will Benefit
Ask most 340B hospital executives what the 340B program pays for, and you will get a warm answer about the safety net. Ask for the receipts, and the conversation tends to end.
That is the whole problem, and the administration has a chance to fix part of it this month. The Centers for Medicare and Medicaid Services (CMS) has proposed a rule that would stop Medicare from paying hospitals far more for certain drugs than the hospitals pay to acquire them. CMS should finalize it.
Congress created the 340B Drug Pricing Program over three decades ago to help safety-net providers improve access to...
Patients Will Feel the Impact of CMS's Fixed-Dose Combination Drug Proposal
As a community oncology practice leader and a cancer patient advocate, we know innovation is about far more than developing new medicines; it is also about finding better ways to deliver them. Patients don't just ask whether a treatment works—they ask how it will affect their daily lives. Will they have to spend hours in an infusion center? Will they need a port? Will treatment allow them to keep working, caring for family, or simply enjoying more time at home? Unfortunately, CMS's proposed changes to the Medicare Drug Price Negotiation Program threaten to undermine advances that have...
Exclusive: Trump Administration’s Head Start FAQ
It has been nearly a month since the Trump administration proposed sweeping changes to Head Start, launching a national debate over the program’s mission, reach, and effectiveness.
The proposed rule is intended to preserve or expand as many as 236,000 Head Start slots nationwide while saving an estimated $2.2 billion—funds the administration says could be reinvested in the program. The proposal quickly drew national attention, prompting headlines across major news outlets and interest from lawmakers in Washington, while earning both praise and criticism.
The Department of Health...
Congress Must End Washington’s Penalty on Prescription Pills
Washington has devised a strange way to encourage medical innovation: Punish researchers for developing medicines that are easier for patients to take.
That is the practical effect of the Inflation Reduction Act’s so-called “Pill Penalty.” Under the law, small-molecule medicines—commonly taken as pills or tablets—become subject to Medicare’s government price-setting program four years earlier than large-molecule biologic drugs. Small-molecule medicines receive only nine years before price controls can take effect, while biologics receive 13.
There is no...
MAHA’s Focus on Early Detection Is Long Overdue
It’s hard to believe that more than 30 years have passed since dark-horse presidential candidate Ross Perot made the national debt a central issue of his campaign. At the time, the debt hovered around $3 trillion—a staggering sum by the standards of the day, to be sure, but hardly the existential threat it represents today.
Since then, nonstop federal spending has catapulted the national debt to more than 10 times that quaint figure. Our enormous debt has eroded the value of the dollar with out-of-control inflation. The debt has emboldened our adversaries to create competing...
Medicare Is Turning the Tide on Healthcare Affordability
Perhaps as a sign of the Centers for Medicare & Medicaid Services (CMS) coming to grips with its inevitable bankruptcy, the agency has recently made a rational decision, however slight. The proposed rule, site neutrality for imaging, reverses an extremely damaging position years ago CMS should never have taken. We can only hope that they will completely reverse the political decision to overpay for hospital provided physician services, a decision which has all but decimated the private practice of medicine in the US.
Right now, Washington often pays hospitals more than independent...
Provider Taxes Aren’t Medicaid Fraud
Fraud, waste, and abuse in Medicaid should be aggressively rooted out. The Trump-Vance Administration’s recent health care fraud enforcement demonstrates exactly how accountability should work. But some in Washington want to attack provider taxes as fraud. This is plainly false. Provider taxes are a lawful, transparent financing mechanisms that have become indispensable because federal reimbursement has failed to keep pace with the cost of providing care.
Washington must recognize that provider taxes are one of the last remaining tools keeping hospitals open in communities too...
The Compounding Loophole Has Become a Business Model
There is an old Washington rule worth remembering: Never let a temporary emergency become a permanent business model. That is precisely what is happening with mass drug compounding.
Large-scale compounding was supposed to be an emergency pressure valve. When an FDA-approved medicine became genuinely scarce, compounders could step into the breach and help make sure patients were not left without treatment. It was an accommodation born of necessity, not an invitation to create a shadow pharmaceutical industry. Somewhere along the way, the exception began swallowing the rule.
Today, too much...
My Brother's Legacy Started with Grief
There is a particular kind of love that makes a person cross oceans for someone they can't yet find. It sends parents to countries they've never visited, chasing rumors and blurry photos. It keeps siblings awake at 3 a.m. messaging strangers in a language they don't speak, because somewhere out there is someone who might know something. Families do this constantly, quietly, all over the world, and most of the time no one is watching. I know, because four months ago, I became one of them.
On August 30, the U.S. observes National Grief Awareness Day, a day set aside to talk openly about loss....
The FDA Is Making It Harder to Quit Smoking
Tobacco regulation should make it easier to quit smoking, not harder. Cigarettes, the product responsible for the overwhelming majority of tobacco-related disease, remain widely available, while less harmful alternatives such as vaping face flavor bans and one of the Food and Drug Administration’s (FDA) most restrictive approval processes. The result is a system that makes it harder for smokers to quit, compromising public health instead of protecting it.
As of May, the FDA had authorized 45 e-cigarette products, also known as vapes, for sale. When it finally authorized its first...
PACE Works. Now Let's Make It Easier for Seniors to Access It.
For too many older Americans, getting the care they need is much harder than it should be. Often, they face a frustrating maze of appointments, paperwork, and fragmented services.
One model is showing that there’s a better way. And it’s popular with program participants, their families, and taxpayers.
In a healthcare system that's full of fragmentation and red tape, the Program of All-Inclusive Care for the Elderly (PACE) offers something refreshingly simple. It’s a one-stop shop for older adults seeking care while they age, offering medical care,...
States Should Not Wait Until 2028 to Open PBMs’ Books
Prescription drug prices do not become opaque by accident. They become opaque because the middlemen who manage drug benefits are allowed to hide many of their revenue streams from the employers, insurers, pharmacies, and patients who ultimately pay the bill. Congress has already recognized the problem. Federal pharmacy benefit manager (PBM) reporting requirements are scheduled to reshape what PBMs must disclose, but many of the most important provisions will not take effect until 2028. That delay creates a basic question for state lawmakers: why wait?
PBMs claim they lower prices by...
Let’s Bring Drug Wholesalers Out of the Shadows
A unifying principle in health care has emerged over the last decade, with patients and policymakers alike demanding greater price transparency. This way patients can become better consumers of care, and employers and government programs can better identify value in the types of care they ultimately pay for. New laws have been enacted requiring transparency for many parts of the system. Still one segment of the drug supply chain with enormous influence...
State Regulatory Overreach Is Bad Medicine for Growth
States compete for investment, jobs and residents. Taxes matter, but so does regulation. Every new mandate consumes resources and management attention that could have been used to expand a business or hire employees.
Reasonable rules can protect consumers. The problem is regulatory accumulation: one layer of government adding requirements before another layer’s reforms have taken effect. According to one estimate, a 10% increase in state regulatory restrictions reduces annual state GDP growth by 0.37 percentage point. Compounded over several years, that means fewer jobs, less investment...
The HHS 340B Pilot: Steering the Program to Its Original Purpose
Program creep is a familiar Washington problem. Good ideas, originally intended to solve targeted challenges, expand beyond their original mission, often bringing higher costs and unintended consequences.
The federal 340B program is a case study in that phenomenon. Congress created 340B in 1992 to help hospitals and clinics serving low-income and uninsured patients stretch scarce resources by providing them deeply discounted drugs. Today, the program has grown far beyond those origins, creating opportunities for hospitals and other health-care providers to generate considerable revenue with...
How Price Controls Could Drive Up Long-Term Drug Spending
It's been four years, nearly to the day [August 12, 2022], since Congress passed the Inflation Reduction Act (IRA) on a party-line vote. The bill accomplished Democrats' longstanding goal of allowing Medicare officials to "negotiate" the price of prescription drugs.At the time, liberal lawmakers claimed these price negotiations would save the federal government more than $100 billion over the next 10 years, with the savings compounding in subsequent decades.Their math was -- and still is -- wildly off. As my University of Chicago colleagues and I show in a new paper, the IRA's price...
Don't Tax the Trillionaire. Task Him.
The world recently minted its first trillionaire, and the inevitable refrain afterward was clear - tax him However, taxing Elon Musk to fund anything chosen by the government is a waste of productivity. Elon’s money is the least valuable thing he owns.
Last year, Nvidia's Jensen Huang — a man not easily impressed by other people's computers — described what happened when xAI built its Colossus supercomputer. Obtaining a hundred thousand GPUs with hardware hitting the floor and training runs in 19 days. Huang called it "superhuman." A project like that, he said, normally...
Who Is Policing the Retatrutide Bootleggers?
In May, I wrote about the emergence of a bootleg market for retatrutide, Eli Lilly’s experimental obesity drug. The problem was already hard to miss. Websites and wellness businesses were selling products they called retatrutide even though the medicine remained in clinical trials, had not been approved by the Food and Drug Administration and had no legitimate commercial supply chain.
Less than three months later, Eli Lilly has filed six lawsuits against businesses it says are illegally selling versions of the drug. The defendants include peptide vendors, a compounding pharmacy and a...
How Vertical Integration—and AARP—Are Driving Up Your Drug Costs
Every year, millions of patients pay their health insurance premiums, trusting their insurer will be there to support them if something happens. What they don't know is that the same company they’re depending on is pocketing their premiums and taking a cut of their prescription payments. For the tens of millions of Americans enrolled in UnitedHealthcare plans, their prescriptions are being routed through UnitedHealth’s own pharmacy benefit manager (PBM), OptumRx, generating billions in financial windfall.
Unfortunately, UnitedHealth is not an outlier but the blueprint for major...
