June 2, 2022
Revcycle Intelligence
By Victoria Bailey
The Community Oncology Alliance (COA) has raised concerns that the high volume of contract pharmacies participating in the 340B drug pricing program allows pharmacy benefit managers (PBMs) to profit from the savings instead of directing savings toward underserved patients.
In an amicus brief filed with the US Court of Appeals for the Seventh Circuit, COA sided with the drug company Eli Lilly in its case against HHS. The organization asserted that the 340B program and its original intentions have been warped due to pharmacies contracting with PBMs.
Under the 340B program, eligible hospitals can purchase discounted drugs from participating pharmaceutical companies. The hospitals are expected to use the savings they gain through the program to improve patient care and lower healthcare costs for underserved populations.
Contract pharmacies play a crucial role in offering access to discounted drugs, as not all safety-net hospitals operate in-house pharmacies.
However, COA’s amicus brief noted that the exponential growth in contract pharmacies is problematic.
Many contract pharmacies are affiliated with or owned by PBMs—fiscal intermediaries that administer and manage drug benefits on behalf of health insurance plans. These for-profit entities are retaining the 340B discounts as profits instead of directing them to patients, COA alleged.
“Parasitic, money-hungry PBMs have taken over and completely mutated the 340B program through contract pharmacy arrangements,” Ted Okon, executive director of COA, said in the press release. “For-profit PBM contract pharmacies siphon 340B discounts away from patients in need and the grantees that serve them, and instead line the balance sheets of some of the largest, most profitable corporations in our country.”
According to the amicus brief, the leading PBM-owned or affiliated contract pharmacies are estimated to retain $2.58 billion in 340B discounts in 2022.
The COA brief cited reports from CVS Health and Walgreens Boots Alliance in which the PBMs stated that 340B profits are critical to their business operations and that restrictive contract pharmacy policies would negatively impact their bottom lines.
COA argued that a lack of oversight from the Health Resources and Services Administration (HRSA) on the use of contract pharmacies has allowed PBMs to exploit 340B savings.
In addition, the brief alleged that the profit opportunities presented by the 340B program have incentivized PBMs to drive out non-affiliated pharmacies, impacting patient and provider access to discounted drugs.
PBMs have engaged in exclusionary tactics to direct patients toward the pharmacies that they own, COA said.
“The 340B program exemplifies how good ideas, no matter how well-intended, can easily go bad if they fall into the wrong hands and are abused,” Okon stated. “PBMs have found their newest victims in the 340B program, and patients with cancer and other serious diseases are left suffering because of it.”
COA’s amicus brief offers a new perspective on the ongoing debate about drug companies limiting drug discounts through the 340B program.
As of May 2022, 16 drug companies have imposed drug discount restrictions, such as only providing discounts at a single contract pharmacy for hospitals that do not have an in-house pharmacy.
Data from 340B Health has shown that these limits impact patient access to low-cost drugs and have led to over $2 million in losses for safety-net hospitals.
Safety-net hospitals and rural critical access hospitals largely rely on their contracts with community pharmacies, as many do not have in-house pharmacies.
HRSA has notified drug companies to restore 340B pricing, but the manufacturers—including Eli Lilly—are fighting back in court. COA has sided with Eli Lilly, claiming that the drug companies are in the right to restrict discounts from contract pharmacies due to their involvement with PBMs.
Recently, the American Hospital Association (AHA) urged the Federal Trade Commission (FTC) to increase surveillance of PBM practices. The trade organization stated that PBMs have created policies that discriminate against 340B hospitals by paying them less than non-340B hospitals for certain outpatient drugs.
The rate of Americans diagnosed with diabetes isn’t slowing down, and the Covid-19 pandemic only exacerbated the risks and concerns for this debilitating chronic disease.
According to the American Diabetes Association, 1.5 million people will be diagnosed with diabetes this year. So why aren’t more people talking about it? The pandemic may have shifted the collective focus. After all, a nation in health crisis mode can only focus on so many problems at once. Yet hospitalizations and deaths due to diabetes or related complications were right behind the elderly and nursing home residents.
Aside from the pandemic pileup, the disease was not getting the attention it warranted, partly because of how the stigma attached to diabetes impacts our concern, even as it affects more people each year.
Between 1980 and 2014, the number of people with diabetes rose from 108 million to 422 million. “Prevalence has been rising more rapidly in low and middle income countries,” reports the World Health Organization. Diabetes can lead to blindness, kidney failure, heart attacks, stroke, and lower limb amputation.
Why Aren’t More People Talking About This?
“Diabetes is always swept under the rug because, in so many people’s minds, they just associate it with bad health habits and being overweight,” says Deena Fink of New York City. The Long Island native bartends in the West Village in addition to running a small online knitting business.
Most days, her Type 1 Diabetes doesn’t slow her down. It’s a disease she has been living with for sixteen years. “What really has to change is the stigma of diabetes,” Deena explains in an interview with Wealth of Geeks.
She is grateful for her health care plan, despite the roadblocks she often faces to receive her medication. “They have to start actually treating it as a chronic illness.”
Like many others during the first months of the pandemic, Deena was afraid to leave her house. “I didn’t even want to leave the house to go grocery shopping,” she says. The risks are different for someone with a chronic illness. “Just getting a cold, I am knocked out for several days.” She also could not get to a doctor’s office.
“You’re supposed to get your A1C done every quarter,” she explains, but she couldn’t see her doctor for a year and a half. So instead, Deena had to estimate what those numbers would be. The A1C test provides a three-month average of what blood sugar levels should be. It’s how a person with diabetes keeps themselves in range.
Deena faces a monthly battle with the insurance company just to receive her regular dosage of three insulin vials. Without insurance, she would have to pay $175 per vial.
The Global Factor
While lifestyle changes such as maintaining a healthy weight and diet, engaging in physical activity, and not smoking may decrease the health risks associated with diabetes, it does not guarantee that the disease won’t have harmful symptoms over time. Additionally, Covid-19 increases these risks across the globe.
Diabetes was responsible for 6.7 million deaths in 2021, according to the International Diabetes Federation. In addition to the 537 million adults living with diabetes today, an additional 541 million have Impaired Glucose Tolerance, a condition that places them at high risk of Type 2 Diabetes.
And what about the financial side? WHO reports that “diabetes caused at least 966 billion dollars in health expenditure – a 316% increase over the last fifteen years.”
As more people are diagnosed, the opportunity for visibility and change grows. Those with diabetes often become advocates for change.
“Stigma can result when you take an ‘invisible’ condition like diabetes out into the open,” says diabetes advocate Michael Donohoe of Ohio. When he was diagnosed with Type 2 Diabetes, he was also diagnosed with a heart condition. “I try to improve awareness and understanding by being as open about my diabetes as possible. I also advocate loudly for people who are newly diagnosed or severely impacted,” he says.
Covid Collision
Although the elderly and nursing home residents were hit hardest by the virus, people with diabetes were right behind them. This news comes to light as the total number of deaths in the United States nears one million.
“People with poorly controlled diabetes are especially vulnerable to severe illness from Covid, partly because diabetes impairs the immune system but also because those with the disease often struggle with high blood pressure, obesity, and other underlying medical conditions,” reports the New York Times.
Those with diabetes have to keep up with their disease constantly. “It’s a disease that’s a pain,” says Deena, “because you never stop taking care of yourself. Every decision you make for every day of your life will affect your diabetes.”
“It’s so much work,” she says, “but it keeps you alive.”
With diabetes diagnoses soaring across the globe, it is only a matter of time before the world stops hiding from this health crisis and confronts it head-on.
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