This latest preliminary injunction is the commission's fourth successful healthcare sector merger challenge within a one-month span.

IQVIA Holdings' proposed acquisition of rival Propel Media has been temporarily enjoined by a federal judge while the Federal Trade Commission works to permanently block the consolidation of the two healthcare advertising platforms.

During a two-week hearing in November and early December before U.S. District Court Judge Edgardo Ramos, the FTC had sought a preliminary injunction for the deal, arguing that consolidating IQVIA's Lasso Marketing and PMI's DeepIntent -- two of the three largest providers of demand-side advertising platforms -- would give IQVIA an anticompetitive edge for a service that targets ads for pharmaceuticals and other healthcare products to physicians.

Regulators had argued that the merger would incentivize IQVIA – described by the FTC as "the world's largest healthcare data provider" -- to withhold information that would kneecap competition from rivals and discourage newcomers from entering the emerging industry. 

Ramos agreed with regulators and in a December 29 ruling said "the FTC has shown that there is a reasonable probability that the proposed acquisition will substantially impair competition in the relevant market and that the equities weigh in favor of injunctive relief."

The FTC will argue for a permanent injunction at an administrative hearing that begins January 18.

FTC Bureau of Competition Director Henry Liu boasted that the injunction is the fourth successful attempt by the commission within the past month to stifle healthcare sector consolidation, which he said has been shown to increase prices and reduce quality for consumers.

"To close out 2023, the FTC secured another significant victory that temporarily blocks an anticompetitive merger that would raise health care prices for consumers," Lui says. "The federal court's order in IQVIA is also a win for the FTC as it continues to challenge anticompetitive deals involving health care and emerging technology platforms."

The FTC sued to block to deal in mid-July, 2023.

Durham, NC-based IQVIA issued a statement saying it was "disappointed by the court's decision."

"We are reviewing the decision and evaluating our options. IQVIA's acquisition of Propel Media would make it easier for patients and doctors to obtain the healthcare information they need to make better decisions that lead to better health outcomes. We maintain that the FTC's arguments in this case are inconsistent with the reality of the marketplace and unsupported by the law," the statement read.

In December, the FTC also successfully challenged Illumina's acquisition of Grail, John Muir's takeover of San Ramon Regional Medical Center from Tenet Healthcare, and Sanofi's acquisition of Maze Therapeutics' Pompe disease drug.

The hospital self-reported the breach that affected more than 54,000 people.

New York Presbyterian Hospital will pay a $300,000 fine for a data breach that for six years sent visitors' personal information captured on the hospital's website ads to Meta and other third-party tech vendors, the New York State Attorney's Office said Wednesday.

According to the AG's office, between 2016 and 2022 NYP used unvetted third-party tracking pixels and tags on its website that sent visitors' data back to vendors whenever the website loaded or when a visitor clicked a link, submitted a form, or ran a search.

A class-action suit filed against NY Pres identifies Meta Platforms, Inc., the parent company of Facebook, as one of the vendors that received the data.

In some cases, the AG's office says, the data sent back to vendors included personal health information along with users' IP addresses and the URL for the webpage that had been accessed.

"If a user searched for a doctor by specialist or condition, researched a health condition, or scheduled an appointment, information about the user's doctor or health condition were in some cases reflected in the URL," the AG's office says in a media release.

"For example, if a user conducted a search using the words 'spine surgery,' the URL of the search result page would include 'spine-surgery' and the third party would receive that health information about the user."

Some vendors also collected "unique identifiers" stored in the users' devises that allowed the vendors to identify the users they had previously interacted with, including first and last names, email addresses, mailing addresses and gender information, the AG says. 

The breach was identified in June 2022 when a journalist reported on the use of the tracking tools on the NYP website. NYP immediately disabled the tracking tools and hired a third-party forensic company to assess the extent of the breach.

In March 2023 NYP formally reported that the breach affected more than 54,000 people.

NY Pres Responds

New York Presbyterian issued the following statement in response to the AG's media release:

"We are pleased to have reached a resolution with the New York State Attorney General on this matter. The privacy and security of our patients' health information is of paramount importance, and the protection of this confidential information remains a top priority. We continually assess our data collection, data privacy, and digital monitoring tools and practices so that they meet or exceed the highest standards."

New Security Procedures

In addition to the fine, NYP will adopt procedures to prevent the disclosure of protected health information through tracking tools, including:

• Maintaining appropriate policies and procedures on the use of third-party tools;
   
• Conducting regular audits, reviews, and tests of third-party tools before deploying them to a NYP website or app;
   
• Conducting regular reviews of the contracts, privacy policies, and terms of use associated with third-party tools; and
   
• Instructing third parties to delete any protected health information they received.

One expert believes that drug price increases will fall in line with inflation as measured by the CPI.

The pharmaceutical sector is a hive of activity these days, buzzing with breakthrough treatments for stubborn diseases such as Alzheimer's and obesity, and with sickle cell anemia, an outfight cure.

These drugs can be very expensive. The gene therapy needed to cure sickle cell anemia, for example, costs almost $3 million per patient. By comparison, the Alzheimer's drug Leqembi, at almost $25,500 per patient, per year, seems like a bargain. The wildly popular weight-loss drug Ozempic, with a cost of merely $900 to $1,300 per month, sounds like a giveaway.

Despite the headlines that conflate expensive new drug treatments with rising drug costs, Eric Tichy, Pharm.D., MBA, vice chair of pharmacy formulary at the Mayo ClinicMayo Clinic, says it's important to make the distinctions between drug costs and drug expenditures.

He offers his thoughts on the topic, and other issues that are expected to confront providers in 2024 in this interview, which has been edited for brevity and clarity.

HL: Do you anticipate big drug price hikes in 2024?

Tichy: There are several things that are going to prevent inflation of drug prices. One of those is the Inflation Reduction Act, which has caps on how much a drug price can be raised year-over-year based on the Consumer Price Index for that given year.

Where we've seen a lot of spend increase over the last couple of years is where there's new drugs developed to treat things that didn't exist before. Think about Alzheimer's disease, where there haven't been effective medications in the marketplace in the last two or three decades. There are some new medications that have been approved to treat Alzheimer's and they're modestly expensive. However, the population of how many people can be treated is very high. That's something that could increase expenditures.

Also, we haven't had effective weight-loss medications until very recently. When you have a therapy that meets an unmet need, there can be huge demand. That's why there's so much uptake of those medications. Those are our biggest drug spends now. Weight-loss drugs will be the No. 1 spend in 2023 once we have all the data.

There's potentially huge downstream savings. We're learning, for example, that some of these medications prevent heart attacks and things like that. But we need time. With some of these savings, we won't see it for 10, 15, 20 years. As we have more of that information over time, it will support the prices of these medications and make the case for why payers should cover them.

HL: What is driving high drug costs?

Tichy: Some of these new drugs treat very rare conditions affecting small populations, and they’re priced to maintain profitability for the manufacturers, despite a low treatment population. If you didn't have these prices, there would not be incentives for manufacturers to develop these products.

The Orphan Drug Act was developed to incentivize production of these rare medications that treat rare conditions, and new developments in medicine have allowed us to get more precise with how we treat these conditions. It's this confluence that's leading to a larger number of high-cost products hitting the marketplace.

There's also an important nuance between drug prices and drug expenditures. I expect the price growth will be close to inflation, maybe even less than inflation. It has been less than inflation for the last couple of years.

People conflate expenditures with prices, and we expect drug expenditures will keep going up. A lot of that's because there are new drugs for things that as of yet don't have treatments, or there are drugs being developed where the current treatment is cheap but ineffective.

HL: How do you see the ongoing drug shortages playing out for hospitals in 2024?

Tichy: Hospitals have had problems with drug shortages for going on two decades and it's gotten worse recently. These shortages are not going to get better unless there are some serious policy changes. I'm optimistic that there's a lot of attention around it, and that Congress is very informed about it.

HL: Have we reached a point where treatments or cures are available – but unaffordable - for diseases such as sickle cell anemia or dementia?

Tichy: The key word is "cure." With sickle cell, for example, you're curing the disease for patients who suffer through a lifetime of illness that might put them in and out of the hospital. They might have to take other expensive medications. Hemophilia patients often spend hundreds of thousands of dollars a year on clotting factor medications. Gene therapies can treat and cure disease in one treatment.

Another challenge is that the healthcare system is designed for chronic therapies. With weight-loss medications, the manufacturer has a patient on that for a lifetime. If they come off the medication they regain their weight. With sickle cell therapy, they do this treatment and they're not going to have symptoms of sickle cell disease for the rest of their lives. How do you pay for that all-in-one, lump-sum upfront? Our healthcare system is not designed to do that.

HL: Didn’t we see that play out with hepatitis C a few years back?

Tichy: That's a great example because about 10 years ago, people were saying, "these hepatitis C medications are going to bankrupt us. It costs $30,000 a month for those therapies." They were $30,000 a month, but for three months of therapy you cured hepatitis C. Now we rarely are treating hep C because we've cured so many people, and by curing hep C we prevent the need for liver transplants and reduce end-stage liver disease and cirrhosis that generates long-term savings.

The financial models are challenging because cost is paid upfront for the medication, rather than like chronic diseases where it spans a patient's lifetime.

HL: Are payers discounting reductions in downstream expenditures?

Tichy: Health insurance companies look at their covered lives and say "the average person that we cover is only with our plan for a few years. The benefits of this medication accrue over a lifetime. When the patient has a heart attack or other complications, they might no longer be on our insurance plan. They're going to be on Medicare by that point."

The benefits of weight-loss medications are paid for by the commercial insurance that they're on now because they're employed, and some benefit is going to accrue to the employer but most of it is going to accrue to Medicare once they're over 65 and not having as many complications in their older age.

That’s one of the challenges. People aren't on the same health insurance plan for their entire lifetime. You could pay for my gene therapy that I got yesterday and a month later I switch companies and that new company gets all benefits and the previous one doesn't.

HL: Are downstream savings a factor in setting the prices for these drugs?

Tichy: Payers and manufacturers are doing those pharma-economic analyses and they're coming up with drug prices based on different models. There may be a disagreement between payers and manufacturers on what that's worth. Obviously, the manufacturer has an incentive to have that be a higher number, and the payer would like it to be a smaller number.

HL: Can this be solved by the market, or will it require government intervention?

Tichy: That has yet to be determined. As the technology gets more effective, these treatments can be brought to market more easily with less cost. Think about the COVID vaccines. These new platforms can bring new vaccines to the marketplace and quickly adapt them to variants. That's how the market, through technological advancements, can bring down costs.

The other thing we need is more competition. When the technological burdens are lower, that creates opportunities for more players to come into the market and leads to downward pressure on prices.

Payers may need to come up with different models and maybe even the manufacturers themselves. Some manufacturers have plans where the cost of the drug is spread out over a number of years and that's a market solution. Instead of having to pay everything up front, you spread it out over three years or more. It gets challenging over the longer term as patients may switch insurance.

HL: How does Mayo Clinic determine who will pay for ultra-high-cost therapies, and what options do you have if insurers won't pay for it?

Tichy: That's a big ethical dilemma. With almost all care that we give, we go through a financial process with the payers to make sure that we have that coverage, because at the end of the day, the patient would be the person who's billed for it. We always work with the patients to make sure that, if their insurance doesn't cover it, we can sometimes look to foundations that can cover the cost of drugs. Sometimes manufacturers have programs that will provide the drug if a patient is not able to afford it.

HL: You say in a recent report that high drug prices "may fundamentally alter how health systems deliver care." How so?

Tichy: Mayo Clinic might see a fair number of patients with rare conditions each year. At other organizations, you might see one patient every couple of years. So, these drugs that cure the disease may not be worth the investment for some smaller organizations. We may end up with a system where there's just a handful of centers across the country that are giving these therapies. The patients get referred to those centers, they get cured from those conditions, and they're no longer a chronic patient at their smaller community hospital.

HL: You talk about collaboration between pharmacy leaders and finance experts to assess financial risk associated with the provision of ultra-high-cost drugs. What would that entail?

Tichy: It's an important part of the treatment process to make sure that you have approval and coverage by the payer before you move forward with therapy. Just the raw cost of gene therapies can create cashflow problems for organizations depending on when they get billed for it versus when they get reimbursed by payers. If I'm going to spend $4 million on one treatment for one patient on a given day, if I do two of those in a month versus 10, that can have a big impact on our finances. Those are the things that we need to coordinate with our finance colleagues.

HL: Could AI help providers address drug expenditures?

Tichy: It could help with medications that have very specific indications and the patients with these conditions are rare. Using a patient's medical record, AI could quickly determine if a patient is eligible for therapy. AI can also alleviate the administrative burden that goes along with pulling all that information together.

AI gains its intelligence through the data that is put into the program, but a lot of clinical trials are done on adult, white males. So sometimes, we don't have the depth and breadth of data for other populations, such as children and minority groups. If there are differences in how patients with different genetic backgrounds respond, we could see harm. Unintentional biases can lead to incorrect treatments.

HL: How do you see the ongoing drug shortages playing out at the hospital level in 2024?

Tichy: Hospitals have had problems with drug shortages for going on two decades and it's gotten worse recently. These shortages are not going to get better unless there are some serious policy changes. I'm optimistic that there's a lot of attention around it, and that Congress is very informed about it.

It requires coordinated action by the government. We need to have industrial policy around generic drugs similar to what we do with food. With the Food and Drug Administration, we don't have food shortages because the Department of Agriculture coordinates and ensures that farms are producing the food that we need. We need something similar around drugs to ensure the continuity of our drug supply.

The growth is in line with pre-pandemic rates; U.S. insured population hits historic high.

The nation's healthcare expenditures hit $4.5 trillion in 2022, increasing by 4.1% to $13,493 per person, federal actuaries reported Wednesday.

The analysis by the Office of the Actuary at the Centers for Medicare and Medicaid Services, published online Wednesday by Health Affairs, notes that strong growth in Medicaid and commercial insurance spending was offset by declining supplemental funding related to the coronavirus pandemic.

Growth in 2022 was faster than the 3.2% rate of growth in 2021, but much slower than the 10.6% rate of growth in 2020 as the pandemic raged.

The 4.1% spending increase in 2022 was also much slower than the year's 9.1% growth in the gross domestic product. Healthcare spending's share of GDP also dropped to 17.3%, lower than 18.2% share in 2021, and 19.5% in 2020, the highest share in history. Per capital health spending grew 3.7%.   

"Healthcare expenditures since 2020 have reflected volatile patterns associated with the COVID-19 pandemic and the federal government's response to the public health emergency," Micah Hartman, a statistician in the CMS Office of the Actuary and first author of the Health Affairs article, says in a media release.

"The growth in healthcare spending in 2022 of 4.1% was more consistent with the pre-pandemic average annual growth rate of 4.4% over 2016-19," Hartman says. "It remains to be seen how future healthcare spending trends will materialize, as trends are expected to be driven more by health-specific factors such as medical-specific price inflation, the utilization and intensity of medical care, and the demographic impacts associated with the continuing enrollment of the baby boomers in Medicare."

The analysis notes that growth in total healthcare spending in 2022 reflected a slowdown in personal healthcare spending that was more than offset by faster growth in non-personal healthcare spending.

The slowdown in personal healthcare spending was pegged to slower growth in the hospital care spending, which fell from 4.5% in 2021 to 2.2% in 2022. Also, dental services spending fell from 18.2% in 2021 to 0.3% in 2022, and physician and clinical services fell from 5.3% in 2021 to 2.7% in 2022.

Non-personal healthcare spending accelerated in 2022 due largely to a turnaround in the net cost of insurance, the analysis shows.

Other highlights:

• Medicaid spending increased 9.6% in 2022 after growth of 9.4% in 2021 and 9.3% in 2020. From 2019-22, cumulative Medicaid spending increased 31%, or 9.4% per year on average, and enrollment accounted for most of the growth as it increased 24.6%. Private health insurance spending increased 5.9% in 2022 after an increase of 6.3% in 2021 and a decline of 0.8% in 2020.
   
• The uninsured population declined in 2022 for the third straight year, falling from 28.5 million in 2021 to 26.6 million in 2022, while the insured share of the population increased to 92%—a historic high. Marketplace enrollment grew by 1.7 million people in 2022, and employer-sponsored insurance grew by 1.5 million people, accounting for 86% of total private health insurance enrollment and 88% of spending. Medicaid enrollment grew by 6.1 million people in 2022. 
   
• Private health insurance spending (5.9% growth)—reached $1.3 trillion in 2022 and accounted for 29% of total health expenditures. Total private health insurance spending increased 5.9% after 6.3% growth in 2021. Private health insurance spending for medical goods and services grew 5.6% in 2022 after growth of 10.1% in 2021. The slower growth was driven by spending for hospital care, physician and clinical services, and dental services, all of which grew more slowly in 2022 than 2021, when a pent-up demand for elective surgeries and procedures forgone in 2020 increased. Per enrollee, private health insurance spending increased at a rate of 4.3% in 2022 after growing 5.9% in 2021.
   
• Medicare spending (5.9% growth)—reached $944.3 billion in 2022, accounting for 21% of total national healthcare expenditures. Total Medicare spending increased at a slower rate in 2022, 5.9%, compared with 7.2% growth in 2021. Per enrollee Medicare expenditures increased 3.8% in 2022, compared to 5.4% growth in 2021. Medicare spending for personal healthcare increased 4.9% in 2022 compared with 9.4% growth in 2021, driven by slower growth in spending for hospital care and physician and clinical services. Fee-for-service Medicare enrollment continued to decline for the fourth consecutive year, decreasing 3.0% in 2022 after falling 3.8% in 2021. Medicare private health plan enrollment grew 8.5% in 2022 compared with a 10% increase in 2021.
   
• Medicaid spending (9.6% growth)—reached $805.7 billion in 2022, accounting for 18% of total national health spending. Medicaid spending increased 9.6% in 2022—the third consecutive year of growth above 9%. Medicaid spending for goods and services increased 9.9% in 2022 (the same growth rate as in 2021) as spending growth for hospital care slowed, offset by a faster rate of growth for other health, residential, and personal care services. On a per enrollee basis, Medicaid spending averaged 1.7% during 2020-22, in part because of large increases in enrollment of qualifying children and adults, who tend to have lower per enrollee expenditures than disabled and elderly enrollees.
   
• Out-of-pocket spending (6.6% growth)—reached $471.4 billion in 2022, accounting for 11% of total national health expenditures. Out-of-pocket spending increased by 6.6% in 2022 after an 11% increase in 2021. Slower growth for dental services, durable medical equipment, and physician and clinical services were the primary contributors to the overall slower growth in out-of-pocket spending in 2022 following rapid growth in 2021.
   
• Hospital spending (2.2% growth)—reached $1.4 trillion in 2022, representing 30% of overall healthcare spending. Growth in expenditures for hospital care was 2.2% in 2022, lower than the 4.5% growth in 2021. The slower growth in 2022 reflected a decrease in hospital care spending by private health insurance, Medicare, and Medicaid and by a decline in other private revenues.
   
• Physician and clinical services spending (2.7% growth)—reached $884.9 billion, or 20% of total healthcare expenditures in 2022. Spending growth increased 2.7% in 2022, the slowest rate of growth in almost a decade and lower than the increases of 5.3% in 2021 and 6.6% in 2020. This slower growth is due to a slowdown in the use of services and slower growth in prices. Spending for independently billing laboratories slowed in 2022 because of reduced COVID-19-related testing.
   
• Retail prescription drug spending (8.4% growth)—reached $405.9 billion in 2022 and represented 9% of overall health spending. Growth in retail prescription drug spending was 8.4% in 2022, faster than the 6.8% growth in 2021. The increase in spending growth for retail prescription drugs was due to several factors, including faster growth in utilization and prices as well as shifts in the mix of drugs purchased.