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.
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.
The Indianapolis-based nonprofit system has admitted no wrongdoing.
Community Health Network will pay $345 million to resolve allegations that "senior management" knowingly billed Medicare in an "illegal scheme" that relied on illicit physician referrals, the U.S. Department of Justice announced this week.
The alleged violations of the False Claims Act and the Stark Law date back to 2008, and stem from a 2014 whistleblower lawsuit filed by CHN’s former CFO/COO Thomas Fischer.
The DOJ complaint alleges that beginning in 2008 and 2009, senior management at CHN launched an illegal scheme to recruit and hire hundreds of local physicians — including cardiovascular specialists, neurosurgeons and breast surgeons — to capture their downstream referrals.
In exchange, the physicians were paid exorbitant salaries that were sometimes double what they earned in private practices. "Community was well aware of the Stark Law requirements that the compensation of employed physicians had to be fair market value and could not take into account the volume of referrals," DOJ says in its complaint.
To cover their tracks, CHN hired a valuation firm to analyze the compensation it proposed paying to its recruited specialists, but knowingly gave the firm bogus compensation figures to gain a favorable review, DOJ says.
The complaint says CHN ignored repeated warnings from the valuation firm about illegally overpaying physicians, who also were awarded bonuses based reaching a target for referrals, also a violation of the Stark Law.
"Hoosier Medicare patients deserve to know that their care is based on their medical needs, not their doctor’s financial gain," U.S. Attorney Zachary A. Myers for the Southern District of Indiana says in a media release.
"When doctors refer patients for CT scans, mammograms or any other medical service, those patients should know the doctor is putting their medical interests first and not their profit margins."
In addition to the $345 million settlement, CHN will be under a five-year Corporate Integrity Agreement with the Department of Health and Human Services' Office of the Inspector General.
CHN Responds
Community Health Network says in a media statement that the more than one-third-of-one-billion-dollars settlement comes "with no finding of wrongdoing" on its part, and that the settlement will be paid from reserves. CHN had operating revenue of $3.1 billion in 2022.
"This is completely unrelated to the quality and appropriateness of the care Community provided to patients," CHN spokesperson Kris Kirschner says. "This settlement, like those involving other health systems and hospitals, relates to the complex, highly regulated area of physician compensation. Community has consistently prioritized the highest regulatory and ethical standards in all our business processes."
"Community's caregivers and our services will not be impacted by the settlement," said Kirschner. "Community's leadership has ensured the ongoing health and growth of the organization," Kirschner says.
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.
Scripps Clinical Medical Group says their now-rescinded mandatory retirement age for surgeons complied with California law.
A physicians group affiliated with San Diego-based Scripps Health will pay $6.8 million to resolve a federal age and disability discrimination suit filed with the U.S. Equal Employment Opportunity Commission.
The settlement for violating the federal Age Discrimination in Employment Act and the Americans with Disabilities Act stems from a 2014 mandatory retirement policy enacted by Scripps Clinical Medical Group for physicians ages 75 or older.
SCMC admitted no liability in the settlement, which the group says it accepted to avoid a costly, lengthy legal battle, and issued the following statement:
"In 2014, SCMG enacted a mandatory retirement policy, which impacted physicians age 75 or older. This policy went into effect in 2016, and was entirely consistent with California law, which specifically allows for mandatory retirement of physicians in medical groups at age 70 (Cal. Code Regs. Tit. 2, § 11084)."
"This policy was put in place to enhance patient safety. Thereafter, the EEOC took the position that this policy, while such a policy is expressly legal under California law, it is not allowed under federal law. As a result, SCMG rescinded the policy in 2018, and the policy has not been in place or utilized for over five years. SCMG recently settled with the EEOC, without any admission of fault or wrongdoing, to avoid the continued expense and distraction of litigation."
The physicians group's four-year conciliation agreement with the EEOC includes a $6.8 million payout to the surgeons affected by the retirement mandate, which Scripps rescinded in 2018. Scripps will also inform employees of the recission and clarify that the company does not have any policy in which age is a factor in making employment decisions, including termination, retirement, and terms and conditions of employment, EEOC said in a media release.
SCMG will also review and revise if necessary its policies against age and disability discrimination, and require training on the subject for division managers and other leaders.
"With demographics showing that many people are remaining in the workforce longer, it is critical for employers to understand the ADEA's protections for older workers," EEOC Chair Charlotte A. Burrows says. "For that reason, the Commission has included discrimination against older workers among the priorities identified in its new Strategic Enforcement Plan."
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 spendingincreased 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.
The 77,000 job gains in November was well above the average 54,000 jobs healthcare created over the past 12 months.
Healthcare accounted for nearly 40% of the 199,000 new jobs created in the United States in November, federal data show.
The 77,000 new jobs reported to the Bureau of Labor Statistics in November is well above the 54,000 average monthly gain over the past 12 months.
Within healthcare, ambulatory care services continued to lead in job creation, accounting for 36,000 new jobs for the month. Hospitals accounted for 24,000 jobs, and nursing and residential care accounted for 17,000 jobs.
The better-than-expected job gains in the overall economy in November lowered the unemployment rate to 3.7%, BLS says, with 6.3 million people reporting as unemployed, about 100,000 fewer than reported in October.
The 199,000 new jobs in November is below the monthly average of 240,000 new jobs over the past 12 months, but it is in line with growth in recent months, BLS says.
Big job gains also were seen in government (49,000), leisure and hospitality (40,000), and professional services (15,000) social services (16,000). Manufacturing gained 28,000 jobs, reflecting the return to work of striking auto workers.
The retail sector was the big loser in November, shedding 38,000 jobs, including 19,000 lost jobs in department stores, and 6,000 jobs at furniture, home furnishings, electronics and appliance retailers.
The average hourly earnings for all employees on private nonfarm payrolls in November rose by 12 cents, or 0.4%, to $34.10. Over the past 12 months, average hourly earnings have increased by 4%. The average hourly earnings of private-sector production and nonsupervisory employees rose by 12 cents, or 0.4%, to $29.30.
November and October job numbers are considered preliminary by BLS, and subject to revisions.
Experts believe that targeted incentives could alleviate longstanding and chronic supply challenges.
A panel of experts told the U.S. Senate Finance Committee this week that targeted incentives and policy shifts by Medicare and other federal government agencies could play a critical role in reducing the nation's chronic shortages of generic drugs.
Inmaculada Hernandez, PharmD, PhD, professor at Skaggs School of Pharmacy and Pharmaceutical Sciences at UC San Diego, told the committee that "generic manufacturers solely compete to sell their product at the lowest price, generating a 'race to the bottom'".
"That price erosion is aggravated by the consolidation of purchasing entities," Hernandez says.
To alleviate the problem, Hernandez says the federal government has several options, and should start by providing low-interest, performance-based, and potentially forgivable loans to incentivize rebuilding the nation's generic drug infrastructure."
In addition, Hernandez says the government should revise drug pay-for-performance reimbursement models "to incentivize the selection of products manufactured in resilient and mature supply chains."
"Supply chain resilience and maturity are crucial for supply stability and continuity," she says. "Supply stability and continuity are elements of value because, when we initiate a patient on a treatment, we not only value the product available for the initial dose, but also the continuity of supply so that a patient can complete the treatment course."
Marta E. Wosińska, PhD, a senior fellow at The Brookings Institution, concurred with Hernandez and told the committee that "CMS should encourage hospitals to place more weight on reliability of manufacturing supply through a pay-for-performance program under Medicare."
Under such a program, Wosińska says hospitals "would be scored on their behavior on two measures: do they buy from reliable manufacturers and do they buffer their inventory."
"Hospitals would be measured on their performance retroactively, on their behavior before the first signal of each shortage that occurs," she says. "The scorecard would then feed into an end-year sliding-scale payment adjustment based on a hospital's performance relative to its peers. Hospitals should largely expect to cover their participation costs, with top performing hospitals exceeding those cost."
Allan Coukell, BSc (Pharm.), senior vice president for public policy at Civica Rx, also noted that "policy responses should focus on changing the current system that causes shortages because it favors low prices over resiliency of supply."
Along those lines, Coukell told the committee that nonprofit Civica Rx, created five years ago by health systems to address chronic drug shortages, has created a roadmap worth emulating when purchasing generics. That guidance includes measures to ensure: at least a six-month buffer inventory; that generic sterile injectables are priced sustainably; support for domestic manufacturing; and "market demand" from drug makers who are less likely to have quality failures.
"If Congress were to create a targeted program to support domestic manufacturers to develop essential products that are at high risk of shortage … domestic manufacturers would then be ready to manufacture on short notice once a shortage starts," Coukell says. "In this way, Congress could create an insurance policy against future shortages at the cost of a one-time investment of $3 million to $4 million per drug."
As consumers struggle with soaring drug prices, AstraZeneca Q3 profits doubled to $1.37 billion.
The pharmaceutical industry is enjoying record profits while simultaneously pursuing lawsuits challenging the Biden administration's efforts to make drugs affordable for Medicare beneficiaries, a patient advocacy group says.
In stark contrast to reports of record profits, Funk notes that 3-in-10 Americans say they can't afford drugs. That has not stopped leading drug makers, including AstraZeneca and trade association PhRMA, from challenging drug price negotiations mandated in the Inflation Reduction Act.
"Another day, another drug company brags of billion-dollar profits while suing to stop the historic Biden law working to lower drug costs for struggling seniors,"Funk says."Big Pharma and their lackeys in Congress are fighting tooth and nail to undo the Inflation Reduction Act's Medicare Drug Price Negotiation Program so that companies can keep squeezing maximum profits out of seniors, including many choosing between food and medicine."
AstraZeneca's Farxiga, used to treat type 2 diabetes, heart failure and chronic kidney disease, is one of the first 10 drugs selected for the initial negotiations. The presumedly lowered prices are projected to save nearly 19 million Medicare Part D enrollees $400 a year by 2025.
Accountable.US says its own research has previously found that the five-biggest U.S.-based pharmaceutical companies spent $112 billion in R&D from 2019 through 2021, and $125 billion on stock buybacks and dividends over the same period.
"Based on their own earnings reports, it's clear these price hikes are just a way to extract more money from patients in need and redistribute it to wealthy shareholders," Funk says.
AstraZeneca and PhRMA on Thursday did not respond to HealthLeaders' request for comment.
"Too many corporations motivated by greed have jacked up prices despite enormous profits, and Big Pharma is among the worst offenders," Funk says. "Congressional Republicans should be celebrating the historic Biden law allowing Medicare to negotiate cheaper drug prices, not helping pharma CEOs and lobbyists undo it in pursuit of more political donations."
Accountable.US is funded by the social activist private equity New Venture Fund.
The healthcare sector continues to be a job-creating dynamo.
Healthcare accounted for nearly 40% of the 150,000 jobs created in the U.S. economy in March, new federal data show.
Overall job growth in the national economy slowed in October, well below the 258,000 monthly average for jobs gained over the past 12 months, according to the Bureau of Labor Statistics' monthly report on job growth.
The 58,000 healthcare jobs created in October was more than the 53,000 monthly average for new jobs in the sector over the past year, BLS says.
Within healthcare, ambulatory care services continued to lead in job creation, accounting for 32,000 new jobs for the month. Hospitals accounted for 18,000 jobs, and nursing and residential care accounted for 8,000 jobs.
The unemployment rate in the overall economy held steady at 3.9% in October, BLS says, with 6.4 million people reporting as unemployed, unchanged from September. Big job gains also were seen in government (51,000), leasure and hospitality (19,000), and professional services (15,000) social servoces (14,000). Manufacturing jobs fell by 35,000, reflecting the fallout in the automotive parts manufacturing sector owing to the United Auto Workers strike.
The average hourly earnings for all employees on private nonfarm payrolls in October rose by 7 cents, or 0.2%, to $34. Over the past 12 months, average hourly earnings have increased by 4.1%. The average hourly earnings of private-sector production and nonsupervisory employees rose by 10 cents, or 0.3%, to $29.19.
October and September job numbers are considered preliminary by BLS, and subject to revisions.
Unfortunately, the drug shortages are more expansive than that.
A U.S. Senate report released in March found 295 active drug shortages at the end of 2022 for pharmaceuticals ranging from more than a dozen cancer drugs to Children's Tylenol and representing a 20% increase from the 246 drug shortages reported at the end of 2021.
The data, compiled by the American Society of Health System Pharmacists, also found that drug shortages worsened in 2022, growing from 114 to 160 reported shortages, a 40% increase.
These shortages have consequences for public health.
A recent survey of nearly 200 clinicians, pharmacists, and procurement specialist compiled by nonprofit ECRI and its affiliate Institute for Safe Medication Practices found growing concerns that the shortages are hurting patient care, across several specialties, including surgery and anesthetics (74%), emergency care (64%), pain management (52%), cardiology (45%), hematology and oncology (44%), infectious diseases (39%), and obstetrics and gynecology (37%).
Half of the respondents in the ECRI survey report having to delay or cancel surgical procedures and drug treatments, such as chemotherapy, one-third say they aren't able to provide optimal treatment because of drug shortages, and one quarter say they know of at least one error related to a drug, supply, or device shortages.
"While medication and supply shortages have been widely reported across healthcare, we now know with certainty that these shortages are causing preventable harm and have the potential to cause even more if they are not addressed soon," says ECRI President / CEO Marcus Schabacker, MD, PhD.
"There are strategies hospitals can use to reduce the impact of shortages, but they are a deviation from standard practice and resource-intensive—two characteristics that themselves can increase the likelihood of preventable harm," he says.
The problems the drug supply chain faces are very much like the problem shortages of personal protective equipment and single-use clinical supplies.
There are several explanations for the shortages, including product quality and sanitation issues, drugmakers abandoning cheaper generics, and natural disasters. However, the biggest single hurdle – and the hardest to clear -- is that most of the shortages begin outside of United States, limiting our options for corrective measures.
In a Johns Hopkins podcast examining drug shortages, Mariana Socal, MD, PhD, a policy researcher and associate scientist at the University's Bloomberg School of Health Policy and Management, noted that the "drug supply chain typically starts far away from the U.S."
"Our research has found that over 85% of all of the active ingredients needed to produce generic drugs for the U.S. are produced overseas," Socal says. "These ingredients are then transported to a second player—the facility that will then manufacture the finalized product."
Any single kink in this long, complex, multinational supply chain can derail the entire process. Until the U.S. can find a meaningful, effective solution that can safeguard the supply chain, Socal says providers will have to make do with incremental improvements.
"Other than the companies coming back online and producing the drugs we need, I'm not confident right now that we have a good long-term strategy. This is just a Band-Aid," she says. "And I'm worried for my patients that this could keep happening and could potentially worsen with each shortage, given what we're seeing now."