June 7, 2022
Federal Trade Commission
By FTC
The Federal Trade Commission announced today that it will launch an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers to provide information and records regarding their business practices. The agency’s inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc.
“Although many people have never heard of pharmacy benefit managers, these powerful middlemen have enormous influence over the U.S. prescription drug system,” said Federal Trade Commission Chair Lina M. Khan. “This study will shine a light on these companies’ practices and their impact on pharmacies, payers, doctors, and patients.”
The Commission’s inquiry will examine pharmacy benefit managers’ role at the center of the U.S. pharmaceutical system. Pharmacy benefit managers are the middlemen who are hired to negotiate rebates and fees with drug manufacturers, create drug formularies and surrounding policies, and reimburse pharmacies for patients’ prescriptions. The largest pharmacy benefits managers are now vertically integrated with the largest health insurance companies and wholly owned mail order and specialty pharmacies.
In these roles, pharmacy benefit managers often have enormous influence on which drugs are prescribed to patients, which pharmacies patients can use, and how much patients ultimately pay at the pharmacy counter. Many of these functions depend on highly complicated, opaque contractual relationships that are difficult or impossible to understand for patients and independent businesses across the prescription drug system.
The inquiry is aimed at shedding light on several practices that have drawn scrutiny in recent years including:
- fees and clawbacks charged to unaffiliated pharmacies;
- methods to steer patients towards pharmacy benefit manager-owned pharmacies;
- potentially unfair audits of independent pharmacies;
- complicated and opaque methods to determine pharmacy reimbursement;
- the prevalence of prior authorizations and other administrative restrictions;
- the use of specialty drug lists and surrounding specialty drug policies;
- the impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients.
The FTC’s inquiry will build on the significant public record developed in response to the request for information about pharmacy benefits managers that the agency launched on Feb. 24, 2022. The agency has received more than 24,000 public comments to date.
The FTC is issuing the orders under Section 6(b) of the FTC Act, which authorizes the Commission to conduct studies without a specific law enforcement purpose. The companies will have 90 days from the date they receive the order to respond.
The Commission voted 5-0 to issue the Section 6(b) orders and conduct the study of pharmacy benefits managers’ business practices. Chair Lina M. Khan , Commissioner Rebecca Kelly Slaughter, and Commissioner Alvaro Bedoya issued statements. Commissioners Noah Joshua Phillips and Christine S. Wilson issued a joint statement.
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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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