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#Pharmaceutical Care Management Association (PCMA)
reportwire · 2 years
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Judge strikes down CMS' Medicaid copay rule, handing PhRMA major win
Judge strikes down CMS’ Medicaid copay rule, handing PhRMA major win
Judge strikes down CMS’ Medicaid copay rule, handing PhRMA major win rking Thu, 05/19/2022 – 15:08 Source link
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spectrumpsp · 2 years
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Why do insurers use PBM?
Pharmacy benefit managers, liaisons between drug companies and health insurers who administer consumers' prescription benefits, are at the center of the discussion about why drug prices in the United States are so high.
PBMs were founded in 1968 to handle claims and negotiate lower costs with pharmaceutical manufacturers. PBMs already manage prescription drug coverage for more than 266 million Americans with health insurance.
The Federal Trade Commission is expected to investigate the PBM industry's refund policies this year.
What do PBMs do?
PBMs manage patient drug benefits for health insurers, large employers, Medicare prescription drug programs, and other health benefit providers.
They negotiate price reductions with pharmaceutical companies and govern how pharmacies are rewarded for dispensing drugs. A formulary is a list of preferred medications in a health plan. They also set the amounts of co-payments for patients.
The Association for Pharmaceutical Care Management, which represents PBMs, reports that they save 40% to 50% on prescription drugs or $962 per person each year.
There are concerns about how much PBMs withhold from rebates negotiated with drugmakers and how much is passed on to consumers, health insurers and employer plans.
According to critics, PBMs may have distorted incentives. Because they get discounts and rebates, they may prefer more expensive drugs on formularies.
According to drug manufacturers, paying discounts and rebates to PBMs leads to higher initial list prices. On the other hand, health insurers argue that manufacturers, not middlemen like PBMs, set high prescription prices.
Independent pharmacies say the structure of the supply chain puts them at a disadvantage, as Pharmacy Benefit Managers (PBMs) refer patients to pharmacies or mail-order companies run by insurers that own the PBMs.
With "differential pricing", PBMs charge the insurer or employer more for the drugs than they reimburse the pharmacy, and keep the difference for themselves. This practice has caught the attention of lawmakers. The Congressional Budget Office estimated that eliminating differential pricing in the Medicaid program for low-income people would generate about $900 million in federal savings.
DIR, or “direct and indirect compensation expense,” is a strategy some analysts say PBMs use to increase their bottom line. PBMs charge after-sales fees to healthcare professionals in the network (oncology practices say they are particularly affected) or pharmacies, often months after a patient's medicine has been dispensed.
The PBM industry argues that it lowers prescription costs by negotiating discounts directly with drug manufacturers for listing excessively high prices. The PCMA says the pharmaceutical industry's use of "coupons, co-pay cards, direct-to-consumer advertising and physician fees" is keeping prescription prices high.
PBMs are responsible for reimbursing pharmacies for dispensing drugs to patients. The pharmacy has no control over the sale of the drug. Although having already incurred storage and distribution expenses. The PBM determines the patient's co-payment and the number of reimbursement pharmacies they will receive for each drug covered by the drug plan.
PBM establishes in advance the cost of each drug covered by the plan, and this is the amount that is reimbursed to pharmacies other than its own. Reimbursement rates are often well below the cost of the drug, forcing pharmacies to fill prescriptions at a loss. No one knows how the cost of each covered prescription is determined because PBMs are unregulated and not required to provide their formulas. This information is a "trade secret" of PBM, leaving pharmacists no choice but to appeal any losses they incur in filling the prescription. Despite New York State rules that set out extremely specific appeal procedures, PBM frequently denies or ignores these challenges.
What is the role of Pharmacy Benefit Managers?
PBMs were created in the 1960s and worked for insurance companies to reduce the cost of pharmaceuticals through claims processing. Today, PBMs are significantly more powerful. Among the top 25 Fortune 500 companies, CVS, Express Scripts and Optum are the three largest PBMs in the country.
PBMs do business with virtually all participants in the pharmaceutical supply chain:
insurers For insurance companies and other insurers, PBMs produce forms. A formulary is a list of medications covered by an insurance plan. PBMs have the power to choose which drugs patients will use and how much they will pay for them.
Pharmacists. PBMs deal with pharmaceutical companies to buy prescription drugs for insurance companies.
Pharmacy. PBMs have agreements with pharmacies for the delivery of drugs. PBMs can determine if the pharmacy you select is part of your insurer's network.
Pharmacy benefit managers subject to regulation?
Of course. There are a variety of activities that could be undertaken to better regulate PBMs and reduce the cost of prescription drugs for patients, such as:
Promote transparency
There would be less room for covert manipulation if PBM's actions were more transparent. For example, on January 2, 2022, New York enacted a new law to increase transparency in prescription drug prices and establish criteria that PBMs must meet.
Restriction of discounts
Most reimbursements should go to insurers or patients by law. As an incentive to negotiate costs with drug manufacturers, they could allow a small portion of discounts to continue.
Enforcement of Antitrust Laws
Antitrust authorities must prevent large PBMs from associating with smaller companies. Agencies should also prohibit PBMs from favoring their pharmacies over competitors.
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Colorado’s rural pharmacies wrestle against big business to remain community cornerstones
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Colorado News
CHEYENNE WELLS – Ted Billinger Jr. closed his pharmacy in this prairie town on March 13, 2019, as the worst storm on record hit Colorado. He delivered a prescription for a child with the flu and one to the local nursing home, went home, had a heart attack in his backyard and died.
For nearly 66 years, Billinger’s family had run the Wells Pharmacy in this town of 850 near the Kansas border and Ted Jr., 71, was a pillar of the community, as well as the pharmacist.
“When Ted died, we were all sad, very sad,” said Noni Caviness, 50, a long-time customer. “Then we were all in a panic about where we’d get our meds.”
It turned out there would be an answer 44 miles away over the prairie and fields of winter wheat showing just a hint of early spring green, a landscape broken only here and there by a string of telephone poles or a railroad track.
The Cheyenne Wells story is one being retold across rural America. Since 2003, more than 1,230 rural pharmacies have winked out, including at least 45 in Colorado, according to the Center for Rural Health Policy Analysis. Thirty-two of those closures left Colorado towns with no pharmacy.
“Rural pharmacies play an integral role in rural health care,” said Keith Mueller, director of the center, which is part of the Rural Policy Research Institute at the University of Iowa. “It is about more than filling prescriptions.”
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First points of health care contact getting fewer, farther between 
The local pharmacy is often the first point of contact with the health care system for rural residents, Mueller said. They can offer triage determining whether an ailment can be treated with over-the-counter drugs or needs a physician. They can check blood pressure, offer flu shots and glucose testing. There is now a push to add testing for COVID-19, the disease caused by the coronavirus, to the list.
“Rural pharmacies are a cornerstone of their communities, and the pandemic has only heightened that,” said Gina Moore, an assistant professor at the University of Colorado’s Skaggs School of Pharmacy and Pharmaceutical Sciences.
In the past, the loss of a pharmacy came with a pharmacist’s retirement or death, as replacements were nearly impossible to find. Now, pharmacy operators, state officials and health care economists say these small businesses are being pressured by large pharmaceutical benefit managers (PBMs), middle men between insurance companies and pharmacies.
The PBMs handle the billing, deal with drugmakers and compile the approved list of drugs, known as formularies, for the insurers. The three largest pharmaceutical benefit managers – CVS Health, Express Scripts and OptumRx – collectively serve about 80% of the market covering 180 million Americans, according to a court filing.
“PBMs came into place to promote better practice and establish formularies, and control the drug costs,” Moore said.
Pharmacist Tom Davis, right, owner of the Kiowa Health Mart in Eads, and his head pharmacy tech Jessica Sierra review prescriptions slated for delivery to the towns of Kit Carson and Cheyenne Wells on March 6, 2020. Davis’ pharmacy fills prescriptions for nearby rural communities that don’t have pharmacies. (Mike Sweeney, Special to The Colorado Sun)
Pharmaceutical benefit managers serve as a quality-control agent and negotiate lower drug prices for consumers, saving an average of $962 per person per year, Greg Lopes, a spokesman for the PBM trade group the Pharmaceutical Care Management Association (PCMA), said in an email.
But pharmaceutical benefit managers have also used their market power to dictate to the small pharmacies in complicated contracts, which in some cases allow the PBM to pay less than it costs a pharmacy to purchase a drug. “It is take it or leave it, so they pretty much have to take those contracts,” Moore said.
More than 40 states have passed laws to regulate some aspects of the pharmaceutical benefit managers. In April, Gov. Jared Polis signed into law a bipartisan bill, supported by both sides of the aisle, to protect independent pharmacies from some of the alleged billing abuses by pharmaceutical benefit managers.
“This is really about proper access to health care,” said state Rep. Sonya Jaquez Lewis, a Boulder County Democrat, licensed pharmacist and the bill’s lead sponsor. “I am glad we can be bipartisan. This is a health care issue, it is a small business issue, it is a rural issue.”
Even the U.S. Supreme Court is set to weigh in as the PCMA sued Arkansas, contending the state lacked the power to ban pharmaceutical benefit managers from reimbursing pharmacies below the cost of a medication.
The PCMA contends that since its plans are regulated under the federal Employee Retirement Income Security Act (ERISA), which preempts state regulation of such plans, the Arkansas laws are not legal.
Arkansas Attorney General Leslie Rutledge said her state was not trying to regulate the plans themselves, only the reimbursements from its agent, the pharmaceutical benefit managers.
 The U.S. Solicitor General and 45 states, led by California, have filed briefs supporting Arkansas as the case is seen as decisive in the ability of states to regulate pharmaceutical benefit managers. Oral arguments are set for October.
Pharmacist’s death tore a bigger hole in the retail fabric
Back in Cheyenne Wells, the fate of the Wells Pharmacy, while truly tied to the big battles taking place in state capitols and courthouses, had left townsfolk with more immediate problems. Not only had the town lost its pharmacy, it had lost another downtown business.
“The ALCO and Shopko both closed, so there is no clothing store in town,” said Nancy Bogenhagen, a former county commissioner and the publisher of The Range Ledger, the local weekly.
The feed store closed a couple of years ago as did a fabric shop, leaving South First Street, the town’s main thoroughfare, gap-toothed and hollow.
“The pharmacy was important for health care, but for a little town, a pharmacy is also a huge economic engine,” said Dr. Kurt Papenfus, chief of staff at the local 25-bed Keefe Memorial Hospital. “It is a reason people come to town.”
A truck pulls farm equipment along Colorado State Highway 287 March 6, 2020 in Eads, Colo. The small farming town in Kiowa County on Colorado’s eastern plains has a population of just under 600. (Mike Sweeney, Special to The Colorado Sun)
Oil and gas drilling and agriculture are the two main economic drivers for the area, but drilling is down, with only eight wells brought online in the past 12 months, and no new drilling permits pending, according to state records.
Since late 2019, four farms and ranches were sold at auction. In three cases, the children inheriting the family farm or ranch put them on the block. “It is easier to split money than land,” said David Larsen, 68, the owner of the Cheyenne County Abstract Co. “That’s common when it gets down to the children.”
Cheyenne Wells, however, is nothing if not resilient, Bogenhagen said. In 1977, the town was buried in tumbleweeds, which created barriers 8-feet high on South First Street. Now the town holds a Tumbleweed Festival every July.
Help for Cheyenne Wells was 44 miles away, in Eads
To fix their pharmacy problem, community leaders turned to Tom Davis, 68, the owner of the Kiowa Health Mart in Eads, a town of 630, 44 miles away in the next county. Eads, by all accounts, is the smallest town in Colorado with a pharmacy.
“There was a time every one of the towns out here had a pharmacy,” said Davis, who as a teenager was soda jerk behind the fountain at a drugstore run by Miles Vana in Holly, a town four miles from the Kansas border. “He was my mentor,” Davis said.
Back in 1974, Davis was just out of pharmacy school and Walgreen’s recruited him for a corporate job, but Vana approached him with idea of taking over an abandoned pharmacy in Eads. Davis has been there ever since.
Seeking out Davis made some sense. Davis and his brother had also revived an abandoned pharmacy in Ordway and since then, with additional partners, including his son Ky, added pharmacies in Rocky Ford, Las Animas and Lamar.
“There was a time every one of the towns out here had a pharmacy,” said Davis, who as a teenager worked as a soda jerk behind the fountain at a drugstore in Holly, a town four miles from the Kansas border.
The Kiowa Health Mart Pharmacy store front, shown on March 6, 2020, in Eads. The business is something of a rarity: an independently owned rural pharmacy. (Mike Sweeney, Special to The Colorado Sun)
Davis said he looked at the Wells Pharmacy books and as a businessman, could see the store wasn’t viable for a new owner. But as a pharmacist and a lifelong resident of these prairie lands, he knew what the drugstore meant to the life of the town.
The Billinger family sold the store to Davis, who remodeled it and turned it into a gifts and sundries shop. The old prescription counter remained, but now the scripts would be phoned in and filled at the pharmacy in Eads, then carried daily by courier to Cheyenne Wells.
The arrangement boosted the Eads pharmacy’s prescription volume by about a third. “That really helped us out, too, because our store was borderline,” Davis said.
On a morning just before the novel coronavirus pandemic locked down Colorado, as well as much of the nation, the Kiowa Health Mart was bustling. In the front, shelves were being stocked, and in the back of the store, Davis and his pharmacy technicians Jessica Sierra and Mei Lan Lening were handling prescriptions, which came by phone, fax and email.
They all ended up in a computerized queue that generated bar-coded labels, which when scanned, identified the medicine to be bottled. The same machine also counts out the pills.
“We are kind of high tech for a little pharmacy,” Davis said.
Customers ambled in to pick up a prescription, buy a greeting card, drop off a package for UPS pickup or in the case of one toddler, get a helium-filled balloon.
“They’re making a big thing of this coronavirus — too big,” a weathered 72-year-old in a baseball cap named Scotty told Davis. 
“Well, it is pretty serious,” Davis replied.
“You know they are working on a vaccine,” Scotty said. “Well, the cattle vaccine is good for coronavirus. It’s right there on the label.”
“It’s a different strain, Scotty,” Davis said. 
“Well, I still think it can work,” Scotty offered.
Since that day, the pharmacy has continued to operate with Davis and his staff in surgical masks. “We’ve kept the store open, though we are doing more curbside pickups,” he said.
This service isn’t such a big departure from the past as the pharmacy has always offered home delivery and Davis sometimes has reopened the store after hours to provide medicine for a child with an earache or someone battling a painful tooth.
“I tried to stock up on items people would need – alcohol, hand sanitizer, over-the-counter cold medicines – but I am only getting 15% to 20% of what we order,” he said.
“When people can’t get those things here, it isn’t like they can just go over to the Walmart,” Davis said. The nearest Walmart is in Lamar, 37 miles away.
Rural pharmacies could help test more people for COVID-19
Even more crucial than providing hand sanitizer may be the local pharmacies’ role in COVID-19 testing.
The federal government has cleared the way for pharmacies to do COVID-19 testing and chains like Walgreens and CVS are gearing-up, but effort has been put into ensuring local pharmacies are included, said Matthew Magner, director of state government affairs for the National Community Pharmacists Association, an independent pharmacy trade group.
If independent pharmacies are not involved, millions of Americans, including those in rural areas, will be deprived of a chance to be tested, Magner said.
Dianne O’Brian is a medical prescription delivery driver for Kiowa Health Mart in Eads, Colo. Four times a week, O’Brian will drive the 90-mile route from Eads along U.S. 287 and U.S. 40, which she describes as “miles and miles of miles and miles,” making stops in Kit Carson and Cheyenne Wells, neighboring towns without pharmacies. (Mike Sweeney, Special to The Colorado Sun)
There have been no cases of the COVID-19 in Kiowa County, where Eads is, and just two identified in Cheyenne County, where Cheyenne Wells is the seat, and the flow of prescriptions has been about the same. Still, the pandemic is weighing on the pharmacy and its customers.
 “I’m tired,” Davis said, “but I feel this is just the first quarter of a four-quarter game.”
On that early spring day, Sierra quickly dispatched each script, with those for pickup at the store placed on shelves and those going to Cheyenne Wells and those to Kit Carson, another small town along the way, in separate boxes.
There were prescriptions for blood pressure, pink eye, asthma, cholesterol, a blood thinner and one for a transplant patient. Davis estimates they fill about 140 prescriptions each day.
The extra volume has helped, but Davis said he still labors under restrictions from the pharmaceutical benefit managers. “Sometimes it feels like I am in some Third World country, where I am being dictated to on how I can serve my patients.”
Two big financial challenges center on the reimbursements from the pharmaceutical benefit managers under what are called Direct and Indirect Remuneration fees (DIRs).
Under these fees, the pharmaceutical benefit managers collect rebates from drug manufacturers and concession fees from pharmacies. Sometimes DIRs payments are set below the price a pharmacist pays for a drug. The pharmaceutical benefit managers say this helps keep down drug costs for consumers.
Michelle Neibert, right, rings up a prescription for Kerri Wilms at Teddy B’s March 6, 2020 in Cheyenne Wells. Niebert’s brother Ted Billinger died unexpectedly in 2019 leaving the small town on Colorado’s plains without a pharmacist. Wilms’ prescription was filled at the Kiowa Health Mart in Eads, 45 miles away. (Mike Sweeney, Special to The Colorado Sun)
In the first 10 days of March as a result of DIRs, Davis was paid less than his cost of a drug on 172 of 1,300 Kiowa Health Mart prescriptions. It added up to nearly $2,200, although Davis said that he will get some of that back from suppliers.
The other problem with DIRs is clawback provisions in which pharmaceutical benefit managers reclaim a portion of a fee already paid for a prescription, contending a pharmacy failed to meet some performance metric. This can add up to tens of thousands of dollars in a year.
“The single biggest reason pharmacies are closing is DIRs,” Davis said. “Trying to guess what they will pay us is a shell game. … If everything was above board, with a fair fee, we’d be OK.”
Lopes, with the pharmaceutical benefit managers trade group, maintains that use of DIRs “improves patient health outcomes through increased prescription drug compliance, and reduces out-of-pocket costs for patients through lower premiums.”
For several years, the battle over pharmaceutical benefit managers has been waged across the country. “PBMs are treating pharmacies as an additional revenue stream,” said Magner of the National Community Pharmacists Association.
A federal Centers for Medicare & Medicaid Services report said that between 2010 and 2017, pharmacy price concessions, including performance-based concessions, to pharmaceutical benefit managers rose 45,000%. 
“Are pharmacies doing a 45,000% worse job?” Magner asked.
There have been other problems. For example, in some cases, the insurance co-pay for a drug would exceed its over-the-counter price, but under their pharmaceutical benefit manager contracts, pharmacists were “gagged” from telling that to patients.
Dianne O’Brian arrives with her delivery of prescription medicine at Teddy B’s, the former Wells Pharmacy, March 6, 2020 in Cheyenne Wells, Colo. O’Brain delivers prescriptions from the Kiowa Health Mart in Eads, a 90-mile round-trip, four times a week. (Mike Sweeney, Special to The Colorado Sun)
In the past two years, 32 states, including Colorado, have passed anti-gag legislation. In October 2018, President Donald Trump signed legislation sponsored by Sen. Debbie Stabenow, a Michigan Democrat, and Sen. Susan Collins, a Maine Republican, banning gag clauses in pharmacy contracts.
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Senior citizens with Medicare Part D drug benefits paid an extra $135 million in 2013 because of gag clauses, according to a University of Southern California study.
Pharmaceutical benefit managers have also overstepped their audit powers, which are supposed to be limited to detecting fraud, waste and abuse, by disallowing payments for things such as bookkeeping or clerical errors, Magner said. In the past two years, 13 states have adopted Fair Pharmacy Audit laws.
Then there is the problem of the “spread pricing” where an insurance company pays one price for a drug while the pharmaceutical benefit manager pays the pharmacy less and pockets the difference.
Pharmaceutical benefit managers manage the Medicaid pharmaceutical programs for many states, though not Colorado. An audit by the Ohio Department of Medicaid found that in 2017, out of its $2.5 billion Medicaid drug program, pharmaceutical benefit managers had pocketed $223.7 million from spread pricing.
In Kentucky, pharmaceutical benefit managers made $123 million in spread pricing from Medicaid in 2018, according to a state report.
 “Now it wasn’t just costing patients money, it was costing taxpayers’ money,” Magner said. “That is why we are seeing a lot more regulation.”
The PCMA said it is the insurance plans that choose to use spread pricing, paying a fixed drug cost while letting the pharmaceutical benefit managers assume the risks of variable pricing. “The health plan sponsor hiring a PBM always has the final say on contract terms,” Lopes said.
Pharmaceutical benefit managers were also found to give preferential pricing to their own pharmacies. CVS Health reimbursed CVS pharmacies $400.65 for a fentanyl patch while paying non-CVS pharmacies $75.74, according to a filing in the Supreme Court case. CVS pharmacies got a $5.86 reimbursement for ibuprofen, non-CVS pharmacies $1.39.
“It’s like whack-a-mole,” Magner said. “There has been one issue after another with the PBMs.”
COVID-19 has become another mole to whack. Since the pandemic took hold, the number of prescriptions being reimbursed below cost has risen to 85%, and two-thirds of independent pharmacies are reporting negative cash flow, according to the community pharmacists’ association, Magner said.
Read more health stories from The Colorado Sun
The battle over prescription pricing is one of life or death for independent pharmacies. “Ninety-five percent of the average pharmacy’s revenue comes from scripts and about 5% from out front,” Davis said. “You can’t run a business losing money on scripts.”
The Kiowa Health Mart is a bit of an anomaly, Davis said, getting 15% of its revenue out front and not just from over-the-counter drugs, cosmetics and greeting cards, but from also selling underwear, pressure cookers, pet vitamins and planters in the shape of a cowboy boot.
By 1 p.m., Sierra had completed the prescriptions for Cheyenne Wells and Kit Carson, and they filled two canvas sacks. There were 51 prescriptions for Cheyenne Wells.
Mason Wise, 23, took the bags and drove 21 miles north on U.S. 287 to Kit Carson, where he deposited one bag at the little grocery store and then drove on to Cheyenne Wells with the rest of cargo.
Blanca Hendrickson, the store manager at Teddy B’s in Cheyenne Wells calls customers letting them know their prescriptions — filled 45 miles away at the Kiowa Health Mart Pharmacy in Eads — are ready to be picked up. (Mike Sweeney, Special to The Colorado Sun)
Wise pulled up in front of the renovated Wells Pharmacy, now dubbed Teddy B’s in honor of Billinger. Inside, Michelle Neibert, 58, took the white paper bags holding the drugs out of the sack and put them in a locker under the big “Prescriptions” sign from the old pharmacy.
Neibert is Billinger’s sister and has worked in the store all her life. “We all grew up in this pharmacy,” she said. “It put four kids through college.”
Ted Billinger Sr. opened his first pharmacy in 1953 and down in the basement are stored decades of prescriptions written by doctors for patients, both long gone.
Customers began to come in at a steady clip to pick up prescriptions. Carl Hapes Jr., 81, came in wearing a red MAGA cap. He ran Hapes Garage in town for 65 years and is a regular customer for blood pressure medicine, although today he was fetching a prescription for his wife.
Dixie Leflore, 55, a home health care worker and a customer for 28 years, ran in to pick up medicine for one of her patients, a 90-year-old woman.
“We are blessed to have these guys from Eads,” she said. Without them, Leflore added, handling her charge would be much more difficult. “If they weren’t here, I’d have to load her up in the car, because I can’t leave her alone too long, and drive to the pharmacy in Burlington.” A round trip of nearly 77 miles.
Since the pandemic hit, folks are still coming into the store, though nearly everyone is wearing a mask and curbside pickups and home deliveries are up, store manager Blanca Hendrickson said.
Dr. Papenfus dropped into Teddy B’s. “Rural life and rural medicine are different,” he said. “We don’t have a single traffic light in Cheyenne County. … People are self-reliant. Social distancing isn’t as much of an issue when you have 1.2 people per square mile.”
The story is the same for medicine out here, where resources are spread thin and a bad traffic accident can overwhelm the little emergency room at Keefe Memorial. In this land, the loss of a pharmacy is most keenly felt.
“I can write all the prescriptions I want,” Papenfus said, “but they have to be filled somewhere.”
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syrtissolutions · 5 years
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SUPREME COURT TO WEIGH IN ON PBM REIMBURSEMENT RATES
Recently, the Supreme Court announced that it would review the decision from Rutledge v. PCMA, a case from Arkansas dealing with the state's legal right to regulate reimbursement rates from pharmacy benefit managers (PBMs). Their ruling could significantly impact pharmaceutical drug costs and PBM business models. The initial briefing and oral arguments should take place between March and April.
The case under review is from the 8th U.S. Circuit Court of Appeals where the court ruled in favor of PBMs and denied Arkansas the regulatory authority (Arkansas Act 900) to increase reimbursement rates for prescription drugs. According to the Court of Appeals, the Employee Retirement Income Security Act of 1974 (ERISA) prevents states' from regulating PBM's reimbursement rates.
The Supreme Court's decision to review the case comes at a time when skyrocketing health care costs are a key issue for states and PBMs have been criticized for adding to the problem. Critics argue that PBMs are profiting from spread pricing by keeping the difference between what they charge plans for medications and what they reimburse to pharmacies. According to the petition to the Supreme Court, below-cost reimbursement rates have "driven more than 16% of independent rural pharmacies from the healthcare marketplace, and in many communities, nothing has replaced them".
The National Community Pharmacists Association's (NCPA) vice president, Mustafa Hersi is hopeful about the ruling. He explained, "We feel that this matter has national implications. PBMs have been relying on ERISA preemption to avoid meaningful oversight by states, and states like Arkansas have taken it upon themselves to draft well-tailored legislation-- that does not implicate or involve ERISA-- to regulate PBMs that operate within their state. The implications are that, if the court were to not only grant the request but rule in the favor of Arkansas, that states would be empowered to make more decisions to regulate PBMs and the role that they have in our health care system so that their citizens can make informed decisions with the respect to the choices that they have in health care."
The Pharmaceutical Care Management Association (PCMA) opposes the petition. In response to the Supreme Court's decision, the lobbying group stated, "The Employee Retirement Income Security Act (ERISA) has long enabled employers to provide consistent, nationwide health care benefits due to its preemption of state laws. We are committed to federal preemption, which is a vitally important issue to ensuring high quality health care for patients. Unique state laws governing the administration of pharmacy benefits are proliferating across the country, establishing vastly different standards. These inconsistent and often conflicting state policies eliminate flexibility for plan sponsors and create significant administrative inefficiencies. These inefficiencies divert funds from where they should be spent: providing access to the health care services on which employees of plans across the country rely. We are confident in the merits of our arguments in this case and look forward to presenting them before the U.S. Supreme Court."
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Insulin Market - Size, Share, Outlook, and Opportunity Analysis, 2018 – 2026
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New product development and launches are expected to drive growth of global insulin market
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Furthermore, in February 2018, Sanofi Aventis launched Toujea in India, a next generation basal insulin, with once or daily usage forms which improves glycemic control in adults with type 1 and type 2 diabetes. Increasing investment on research, development, and manufacturing of anti-diabetic drugs is expected to boost global insulin market
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In September 2017, Biocon Limited received funding from Juvenile Diabetes Research Foundation (JDRF) to study safety and efficacy of insulin Tregopil in diabetic patients. Insulin Tregopil is currently undergoing a pivotal Phase II/III study in type 2 diabetes patients in India. This fast acting insulin can improve post prandial glucose control with fewer side effects.
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Moreover, in September 2018, GeneSys Biologics Private Limited expanded research, development, and manufacturing unit in India for the development of insulin and its analogues biosimilars, allowing its research and development unit for commercial manufacturing.
Development of the insulin pens by various manufacturers is also expected to boost the global insulin market. For instance, in August 2018, Julphar Gulf Pharmaceutical Industries, one of the largest pharmaceutical company of the Middle East and Africa collaborated with Becton, Dickinson (BD) to sell disposable insulin pens in United Arab Emirates (UAE) region and are in final stage of approval and registration. Through this agreement, Julphar’s human insulin formulations Jusline R, Jusline N, and Jusline 30/70 will be available through BD’s portfolio of BD Vystra disposable pens.
However, increasing cost of insulin products especially drugs and stringent regulatory norms for approval of new drugs may hamper growth of the market. For instance, according to the Pharmaceutical Care Management Association (PCMA) report in May 2018, insulin price has increased by 10 folds in the past few years. According to PCMA, prices for Humulin/ Novolin have increased from US$ 25 per prescription in 1985 to around US$ 300 in 2016. Also, prices for long-acting insulins have increased from around US$ 100 per prescription in 2007 to around US$ 400 in 2016.Thus, increasing cost of such insulin therapies are restraining the global insulin market growth.
Global Insulin Market - Regional Analysis
On the basis of region, the global insulin market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to hold dominant position in terms of market share in the global insulin market, owing to increasing cases of diabetes, and geriatric population in this region. For instance, according to the Centers for Disease Control and Prevention report 2017, over 100 million adults are suffering with diabetes in the U.S in 2017. Asia Pacific region is expected to witness higher growth due to increasing awareness for diabetic care, favorable government policies, and increasing R&D investments by larger companies.
Global Insulin Market – Competitive Landscape
Key players operating in the global insulin market include Eli Lilly and Company, Novo Nordisk A/ S, Julphar Gulf Pharmaceutical Industries, Sanofi S.A., Biocon Limited, GlaxoSmithKline, and Wockhardt. These companies are adopting strategies such as mergers, acquisitions, expansions, collaborations, and new product launches to retain their position in the global insulin market. For instance, in August 2018, Novo Nordisk acquired Ziylo to develop smart, glucose responsive insulin (GRIs), ensuring optimal glucose control and reducing risk of hypoglycemia.
Global Insulin Market – Taxonomy
The global insulin market is analyzed based on the following segmentations:
By Product Type
Drugs,Rapid Acting,Humalog,Novolog,Apidra,Short Acting,Novolin R
Humulin R,Intermediate Acting,Humulin N,Novolin NLong Acting
Levemir,Degludec,antus,Basaglar,Premixed,Humalog
Mix,Novolog Mix,Drug Delivery Devices,Pens,Syringes
By Distribution Channels
Hospital Pharmacies,Retail Pharmacies,Online Pharmacies
By Region
North America,Latin America,Europe,Asia Pacific,Middle East,Africa
Click To Read More On Insulin Market
About Coherent Market Insights:
Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.
Contact Us:
Mr.Shah
Coherent Market Insights
1001 4th Ave,
#3200
Seattle, WA 98154
Tel: +1-206-701-6702
0 notes
azveille · 5 years
Text
Industry experts weigh in on slew of bills aimed at drug price transparency at hearing
Experts from across the healthcare system weighed in on several House bills aimed at increasing transparency in the pharmaceutical supply chain at a hearing Tuesday.
Seven pieces of legislation, all of which are bipartisan, were on the slate for discussion at the House Energy and Commerce Committee Subcommittee on Health hearing. Amid the political fervor over rising drug prices, shining a light on how prices are determined has been a key focus for policymakers.
However, some in the industry warn that there may be too much of a good thing and that making all data public could undermine the goal of bringing down costs. Kristin Bass, chief policy and external affairs officer for the Pharmaceutical Care Management Association (PCMA), said the group backs releasing data on rebates and negotiations in “aggregate.”
But the pharmacy benefit management (PBM) trade group fears that fully public data would prevent effective negotiation with drug companies, Bass said.
“We have issues around public reporting when it would allow for tacit collusion” among drugmakers, she said.
Mark Miller, executive vice president of healthcare at Arnold Ventures, said greater transparency could “compel the issue forward.” However, on its own, transparency isn’t going to revolutionarily change how drugs are priced, he said.
None of the bills in question for Tuesday’s hearing would have forced PBMs to publicly disclose individual rebates negotiated for specific drugs, though one would make them release the data in aggregate.  
Bass said that PCMA would recommend policymakers release such data by class for those with at least three drugs. It also suggests a lag time of several years for the data to be published to allow PBMs to adjust to existing contracts.
The ongoing debate on whether to eliminate rebates negotiated by PBMs entirely from the system was also on the slate at the hearing. Legislators pushed back on the fact that some PBMs will put drugs with higher list prices on the formulary instead of lower-cost alternatives.
Bass said insurers select drugs with the lowest net price—the price after rebates and other discounts have been factored in—and often that’s the drug with the higher list price.  
Eliminating rebates, she said, would not put pressure on drug companies to lower list prices on their own, a point that others in the insurance industry have also noted. Studies have also suggested that the Trump administration’s plan to do so in Part D would increase premiums and taxpayer spending.
That said, the industry should indeed be looking at the concerns raised by rebates’ critics, she said.
“We do think there is a conversation to be around the price concessions,” Bass said.
0 notes
Text
Insulin Market Impressively growing Opportunities In 2026
The demand for insulin production is increasing to meet the treatment demand of the rising number of diabetic patients relying on insulin. This has led to increasing competition among market players to develop new insulin drugs in the market.
Insulin helps in promoting protein synthesis, glycogenesis, and glycolysis and in uptake of various ions. Earlier, insulin was isolated from sheep, and pigs, but later on, genetically modifying bacterial cells are also used to produce human insulin. Current treatment relies on developing commercial human insulin by recombinant DNA technology.
New product development and launches are expected to drive growth of global insulin market
Oramed Pharmaceuticals, in May 2018, developed the first oral drug delivery system, which stimulates the natural process of insulin in the liver. This insulin product is in phase II of clinical trial under the U.S. Food and Drug Administration (FDA) and this will provide efficient and safer method for delivering insulin therapy to patients.
Furthermore, in February 2018, Sanofi Aventis launched Toujea in India, a next generation basal insulin, with once or daily usage forms which improves glycemic control in adults with type 1 and type 2 diabetes.
Increasing investment on research, development, and manufacturing of anti-diabetic drugs is expected to boost global insulin market
Increasing research activities for the development of innovative diabetic management drugs by using technology such as delivering insulin without needle provides better opportunities for manufacturers in the global insulin market. For instance, from year 1952 to 2017, the American Diabetes Association (ADA) has invested US$ 807.4 million for over 4,700 research projects on diabetes.
In September 2017, Biocon Limited received funding from Juvenile Diabetes Research Foundation (JDRF) to study safety and efficacy of insulin Tregopil in diabetic patients. Insulin Tregopil is currently undergoing a pivotal Phase II/III study in type 2 diabetes patients in India. This fast acting insulin can improve post prandial glucose control with fewer side effects.
Get HOLISTIC Request Sample Copy Of This Business Report:
https://www.coherentmarketinsights.com/insight/request-sample/2183
Moreover, in September 2018, GeneSys Biologics Private Limited expanded research, development, and manufacturing unit in India for the development of insulin and its analogues biosimilars, allowing its research and development unit for commercial manufacturing.
Development of the insulin pens by various manufacturers is also expected to boost the global insulin market. For instance, in August 2018, Julphar Gulf Pharmaceutical Industries, one of the largest pharmaceutical company of the Middle East and Africa collaborated with Becton, Dickinson (BD) to sell disposable insulin pens in United Arab Emirates (UAE) region and are in final stage of approval and registration. Through this agreement, Julphar’s human insulin formulations Jusline R, Jusline N, and Jusline 30/70 will be available through BD’s portfolio of BD Vystra disposable pens.
However, increasing cost of insulin products especially drugs and stringent regulatory norms for approval of new drugs may hamper growth of the market. For instance, according to the Pharmaceutical Care Management Association (PCMA) report in May 2018, insulin price has increased by 10 folds in the past few years. According to PCMA, prices for Humulin/ Novolin have increased from US$ 25 per prescription in 1985 to around US$ 300 in 2016. Also, prices for long-acting insulins have increased from around US$ 100 per prescription in 2007 to around US$ 400 in 2016.Thus, increasing cost of such insulin therapies are restraining the global insulin market growth.
Global Insulin Market - Regional Analysis
On the basis of region, the global insulin market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to hold dominant position in terms of market share in the global insulin market, owing to increasing cases of diabetes, and geriatric population in this region. For instance, according to the Centers for Disease Control and Prevention report 2017, over 100 million adults are suffering with diabetes in the U.S in 2017. Asia Pacific region is expected to witness higher growth due to increasing awareness for diabetic care, favorable government policies, and increasing R&D investments by larger companies.
Global Insulin Market – Competitive Landscape
Key players operating in the global insulin market include Eli Lilly and Company, Novo Nordisk A/ S, Julphar Gulf Pharmaceutical Industries, Sanofi S.A., Biocon Limited, GlaxoSmithKline, and Wockhardt. These companies are adopting strategies such as mergers, acquisitions, expansions, collaborations, and new product launches to retain their position in the global insulin market. For instance, in August 2018, Novo Nordisk acquired Ziylo to develop smart, glucose responsive insulin (GRIs), ensuring optimal glucose control and reducing risk of hypoglycemia.
Click To Reading More On Insulin Market
About Coherent Market Insights:
Also, Coherent Market Insights has a proprietary database of pipeline biologics and biosimilars, called PHASE-XS. This database provides analytical data in addition to the clinical information of ongoing trials for biologics and biosimilars. An amalgamation of more than 30 parameters, PHASE-XS helps biotechnology and pharmaceutical companies to analyze the market trend, competition, and market potential. For more information or to access this database, kindly click on the below link or contact at
https://www.coherentmarketinsights.com/phase-xs/
Contact Us:
Mr.Shah Coherent Market Insights 1001 4th Ave, #3200 Seattle, WA 98154 Tel: +1-206-701-6702 Email:[email protected]
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skyblueinsurance · 6 years
Text
Trump Plan to Curb Drug Prices Targets Rebates to Pharmacy Benefit Managers
Article
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The Trump administration proposed ending a complex system of drug rebates that influence tens of billions of dollars in U.S. pharmaceutical spending, a move that could upend the relationship between drugmakers and pharmacy benefits middlemen.
The proposal, a long-awaited part of the administration’s plan to target high list prices of drugs, would ban rebates paid by drugmakers to pharmacy benefit managers, or PBMs, in government programs like Medicare.
Those rebates have been called anticompetitive by critics, who blame them for forcing many patients to pay more out of pocket. Under the administration proposal, rebates would instead be passed along directly to customers.
The proposal comes ahead of President Donald Trump’s State of the Union address scheduled for Tuesday, handing him a potential win on drug pricing — a major issue for both parties. The measure, released by the Department of Health and Human Services Thursday, would roll back so-called safe-harbor protections for such rebates, which kept them from running afoul of federal anti-kickback laws. The plan isn’t final and will be subject to a 60-day period for public comment.
The changes are “potentially devastating to the current pharma ecosystem,” said Eric Coldwell, an analyst with Baird Equity Research. “The U.S. health-care system is a sandcastle and the tide is coming in.”
Shares of major drug-plan providers fell. CVS Health Corp., which oversees drug benefits for more than 90 million Americans, fell 2.4 percent in late trading in New York, and Cigna Corp., which last year bought PBM giant Express Scripts, declined 1.4 percent.
Drugmakers pay rebates to insurers and PBMs in exchange for preferred status with those plans’ customers. Some of those rebates go toward insurance premiums, while the middlemen keep some for themselves. The pharmaceutical industry has said PBMs prefer higher-priced drugs so they can negotiate bigger rebates and pocket more of the money.
In a statement announcing the proposal, HHS Secretary Alex Azar blasted PBM rebates as “a hidden system of kickbacks to middlemen” that increases drug costs for Americans every day.
“This proposal has the potential to be the most significant change in how Americans’ drugs are priced at the pharmacy counter, ever, and finally ease the burden of the sticker shock that millions of Americans experience every month for the drugs they need,” Azar said in a statement.
Reporting by Bloomberg News over the past three years has examined a variety of pricing practices at PBMs that have been criticized by politicians and others for making it hard to tell where the money is going. In addition to the debate over rebates, PBMs also are under scrutiny over a practice known as spread pricing, a contractual arrangement that allows PBMs to pay pharmacies one price for a generic drug while charging higher prices to their health plan customers.
CVS said drugmakers were to blame for drug costs. “While PBMs have become a convenient target in the fight against skyrocketing drug costs, in reality they serve as a last line of defense for the consumer,” the company said in a statement.
Brian Henry, a spokesman for Cigna, said that rebates had helped keep premiums down overall. “It is short-sighted to look at one component of our offering as having a disproportionate impact on our business model,” Henry said in an email.
Under the proposal, safe-harbor protection would be eliminated for rebates drugmakers pay to pharmacy-benefit managers, Medicare Part D plans and Medicaid managed-care organizations. A new safe harbor would be created for rebates on drug discounts offered directly to patients, as well as fixed-fee service arrangements between drugmakers and PBMs. Without safe-harbor protections, rebate money pocketed by PBMs could be considered an illegal kickback.
Congress
While the out-of-pocket cost for many people picking up drugs at the pharmacy would decline, the premiums they pay for coverage would rise. Premiums for Medicare drug plans under the proposal could increase anywhere from 8 percent to 22 percent while average costs patients pay out of pocket would fall 9 percent to 14 percent, according to the Department of Health and Human Services.
It would be up to Congress to write new laws banning rebates in commercial plans that cover most working-age Americans, and the reception on Capitol Hill was mixed. In the Democrat-controlled House of Representatives, the chairmen of two key committees overseeing health care criticized the proposal.
“The majority of Medicare beneficiaries will see their premiums and total out-of-pocket costs increase if this proposal is finalized,” Ways & Means Committee Chairman Richard Neal of Massachusetts and Energy and Commerce Committee Chairman Frank Pallone of New Jersey said in a joint statement. “We are concerned that this is not the right approach.”
House Speaker Nancy Pelosi likewise urged Trump to work with lawmakers on drug costs.
“President Trump must work with Congress to deliver the real, tough legislation needed to actually drive down the price of prescription drugs for seniors and families across America.” she said in a statement criticizing the plan.
The Pharmaceutical Care Management Association, an industry group for PBMs, said it was reviewing the proposed rule.
“We stand ready to work with the administration to achieve our shared goal to reduce high drug costs,” PCMA Chief Executive Officer JC Scott said in a statement.
The Pharmaceutical Research and Manufacturers of America, the main drug industry trade group, applauded the move. The proposal would “fix the misaligned incentives in the system” that now result in insurers and PBMs favoring medicines with high list prices, PhRMA CEO Stephen Ubl said in a statement.
Copyright 2019 Bloomberg.
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Text
Insulin Market to Witness Widespread Expansion During 2026
The demand for insulin production is increasing to meet the treatment demand of the rising number of diabetic patients relying on insulin. This has led to increasing competition among market players to develop new insulin drugs in the market.
Insulin helps in promoting protein synthesis, glycogenesis, and glycolysis and in uptake of various ions. Earlier, insulin was isolated from sheep, and pigs, but later on, genetically modifying bacterial cells are also used to produce human insulin. Current treatment relies on developing commercial human insulin by recombinant DNA technology.
Request for Sample Copy of Research Report: https://www.coherentmarketinsights.com/insight/request-sample/2183
New product development and launches are expected to drive growth of global insulin market
Oramed Pharmaceuticals, in May 2018, developed the first oral drug delivery system, which stimulates the natural process of insulin in the liver. This insulin product is in phase II of clinical trial under the U.S. Food and Drug Administration (FDA) and this will provide efficient and safer method for delivering insulin therapy to patients.
Furthermore, in February 2018, Sanofi Aventis launched Toujea in India, a next generation basal insulin, with once or daily usage forms which improves glycemic control in adults with type 1 and type 2 diabetes.
Increasing research activities for the development of innovative diabetic management drugs by using technology such as delivering insulin without needle provides better opportunities for manufacturers in the global insulin market. For instance, from year 1952 to 2017, the American Diabetes Association (ADA) has invested US$ 807.4 million for over 4,700 research projects on diabetes.
In September 2017, Biocon Limited received funding from Juvenile Diabetes Research Foundation (JDRF) to study safety and efficacy of insulin Tregopil in diabetic patients. Insulin Tregopil is currently undergoing a pivotal Phase II/III study in type 2 diabetes patients in India. This fast acting insulin can improve post prandial glucose control with fewer side effects.
However, increasing cost of insulin products especially drugs and stringent regulatory norms for approval of new drugs may hamper growth of the market. For instance, according to the Pharmaceutical Care Management Association (PCMA) report in May 2018, insulin price has increased by 10 folds in the past few years. According to PCMA, prices for Humulin/ Novolin have increased from US$ 25 per prescription in 1985 to around US$ 300 in 2016. Also, prices for long-acting insulins have increased from around US$ 100 per prescription in 2007 to around US$ 400 in 2016.Thus, increasing cost of such insulin therapies are restraining the global insulin market growth.
Global Insulin Market – Competitive Landscape
Key players operating in the global insulin market include Eli Lilly and Company, Novo Nordisk A/ S, Julphar Gulf Pharmaceutical Industries, Sanofi S.A., Biocon Limited, GlaxoSmithKline, and Wockhardt. These companies are adopting strategies such as mergers, acquisitions, expansions, collaborations, and new product launches to retain their position in the global insulin market. For instance, in August 2018, Novo Nordisk acquired Ziylo to develop smart, glucose responsive insulin (GRIs), ensuring optimal glucose control and reducing risk of hypoglycemia.
Else Put an Enquiry Before Purchasing Report : https://www.coherentmarketinsights.com/insight/talk-to-analyst/2183
Global Insulin Market – Taxonomy
The global insulin market is analyzed based on the following segmentations:
By Product Type
Drugs
Rapid Acting
Short Acting
Intermediate Acting
Long Acting
Premixed
Drug Delivery Devices
Pens
Syringes
By Distribution Channels
Hospital Pharmacies
Retail Pharmacies
Online Pharmacies
By Region
North America
Latin America
Europe
Asia Pacific
Middle East
Africa
About Coherent Market Insights:
Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.
Contact Us:
Mr. Shah Coherent Market Insights 1001 4th Ave, #3200 Seattle, WA 98154 Tel: +1-206-701-6702 Email: [email protected]
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newsintodays-blog · 6 years
Text
U.S. health secretary says agency can eliminate drug rebates
New Post has been published on http://newsintoday.info/2018/08/20/u-s-health-secretary-says-agency-can-eliminate-drug-rebates-2/
U.S. health secretary says agency can eliminate drug rebates
WASHINGTON (Reuters) – U.S. Health and Human Services Secretary Alex Azar said it was within his agency’s power to eliminate rebates on prescription drug purchases, a key element of the Trump administration’s plan to lower prescription medicine costs.
Such rebates are negotiated in the United States by pharmacy benefits managers (PBMs) to lower the cost of medicines for their clients, including large employers and health plans that cover tens of millions of Americans.
Drugmakers say they are under pressure to provide rebates to the few PBMs that dominate the market, which include CVS (CVS.N), Express Scripts (ESRX.O) and UnitedHealth’s Optum (UNH.N), and that those payers do not pass on enough of those savings to patients – a contention the PBMs dispute. The drugmakers say the rebates force them to raise the price of their therapies over time to preserve their business.
The Trump administration has been receptive to that argument. Azar, in an interview with Reuters on Friday, said rebates created a perverse incentive to continuously raise drug prices.
Azar, a former top executive at drugmaker Eli Lilly & Co, is trying to deliver on President Donald Trump’s promises to lower the cost of prescription drugs for Americans, which Trump made a major priority during his 2016 presidential campaign.
The Department of Health and Human Services last month proposed regulations that would scale back protections for rebates that might otherwise be illegal under a federal anti-kickback law.
The PBM industry has challenged that move, saying HHS cannot eliminate rebates on its own and would need Congress to change the federal statute. The ultimate responsibility for high drug prices, those companies say, lies with the manufacturers who set those prices.
The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, has said the administration’s proposal to scale back protections for rebates raises “troubling questions,” but did not comment on Azar’s latest remarks. The Pharmaceutical Research and Manufacturers of America (PhRMA) did not respond to a request for comment.
Azar contends that the current rebates are a product of previous HHS regulation. “What one has created by regulation, one could address by regulation,” he added.
He did not say when such new regulations, which are being reviewed by the Office of Management and Budget, might take effect. “The question of rebates may very well be fundamental to the issue of how you reverse these constant incentives to higher list prices (for medicines).”
U.S. Health and Human Services Secretary Alex Azar listens to U.S. White House Press Secretary Sarah Huckabee Sanders introduce him during the daily briefing at the White House in Washington, U.S., May 11, 2018. REUTERS/Leah Millis
CAMPAIGN ISSUE
The cost of healthcare, and prescription drugs specifically, is expected to be a major campaign issue ahead of November elections, in which Democrats are seeking to take control of the U.S. House of Representatives and Senate from Trump’s Republicans.
In May, Trump unveiled a “blueprint” comprising dozens of proposed policies to give the government greater leverage over drug prices, but did not support changes to give the federal government’s Medicare health plan for seniors direct negotiating power with drugmakers. Critics say that has spared the pharmaceutical industry any real challenge to its pricing practices.
Azar defended the administration’s actions, noting that more than a dozen leading drugmakers, including Pfizer Inc (PFE.N), Merck & Co (MRK.N) and Celgene Corp (CELG.O), had pledged to hold off on further price increases this year.
“They are seeing where this is going, they are seeing that we are ticking off the blueprint items one by one,” Azar said. “We are not dependent on the voluntary action of pharmaceutical companies. We are not counting on their goodwill or their altruism. … They’re just changing because they see that’s the future.”
Critics say the drug price pledges by major drugmakers are largely window dressing.
Since May, HHS has given Medicare Advantage health plans, which are administered by private-sector health insurers, new tools to lower prescription drug costs.
The agency’s Food and Drug Administration has unveiled a plan to boost the use of biosimilars, which are cheaper versions of expensive biotech medicines. Azar has directed the FDA to establish a working group to study how to import drugs safely from other countries if a drugmaker dramatically raises prices.
The actions have already sparked concerns. Last week, a leading group of rheumatologists met with Azar to discuss concerns over changes to Medicare Advantage that could force some patients to try a less effective, cheaper medication for a period of time before their health plan would cover a more expensive therapy.
HHS said Azar emphasized the agency’s interest in lowering drug prices but expressed openness to alleviating burdens that could be placed on physicians as a result of the new rule.
Azar said he spoke with Trump every few days, either in person or over the phone and that in every conversation, the president wanted to hear about progress on lowering prescription medicine costs.
“I have never once had a meeting or phone call with the president where we have not talked about drug pricing,” Azar said.
Reporting by Yasmeen Abutaleb; Editing by Michele Gershberg and Peter Cooney and David Gregorio
Our Standards:The Thomson Reuters Trust Principles.
Source link
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todaynewsstories · 6 years
Text
U.S. health secretary says agency can eliminate drug rebates
WASHINGTON (Reuters) – U.S. Health and Human Services Secretary Alex Azar said it was within his agency’s power to eliminate rebates on prescription drug purchases, a key element of the Trump administration’s plan to lower prescription medicine costs.
Such rebates are negotiated in the United States by pharmacy benefits managers (PBMs) to lower the cost of medicines for their clients, including large employers and health plans that cover tens of millions of Americans.
Drugmakers say they are under pressure to provide rebates to the few PBMs that dominate the market, which include CVS (CVS.N), Express Scripts (ESRX.O) and UnitedHealth’s Optum (UNH.N), and that those payers do not pass on enough of those savings to patients – a contention the PBMs dispute. The drugmakers say the rebates force them to raise the price of their therapies over time to preserve their business.
The Trump administration has been receptive to that argument. Azar, in an interview with Reuters on Friday, said rebates created a perverse incentive to continuously raise drug prices.
Azar, a former top executive at drugmaker Eli Lilly & Co, is trying to deliver on President Donald Trump’s promises to lower the cost of prescription drugs for Americans, which Trump made a major priority during his 2016 presidential campaign.
The Department of Health and Human Services last month proposed regulations that would scale back protections for rebates that might otherwise be illegal under a federal anti-kickback law.
The PBM industry has challenged that move, saying HHS cannot eliminate rebates on its own and would need Congress to change the federal statute. The ultimate responsibility for high drug prices, those companies say, lies with the manufacturers who set those prices.
The Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, has said the administration’s proposal to scale back protections for rebates raises “troubling questions,” but did not comment on Azar’s latest remarks. The Pharmaceutical Research and Manufacturers of America (PhRMA) did not respond to a request for comment.
Azar contends that the current rebates are a product of previous HHS regulation. “What one has created by regulation, one could address by regulation,” he added.
He did not say when such new regulations, which are being reviewed by the Office of Management and Budget, might take effect. “The question of rebates may very well be fundamental to the issue of how you reverse these constant incentives to higher list prices (for medicines).”
U.S. Health and Human Services Secretary Alex Azar listens to U.S. White House Press Secretary Sarah Huckabee Sanders introduce him during the daily briefing at the White House in Washington, U.S., May 11, 2018. REUTERS/Leah Millis
CAMPAIGN ISSUE
The cost of healthcare, and prescription drugs specifically, is expected to be a major campaign issue ahead of November elections, in which Democrats are seeking to take control of the U.S. House of Representatives and Senate from Trump’s Republicans.
In May, Trump unveiled a “blueprint” comprising dozens of proposed policies to give the government greater leverage over drug prices, but did not support changes to give the federal government’s Medicare health plan for seniors direct negotiating power with drugmakers. Critics say that has spared the pharmaceutical industry any real challenge to its pricing practices.
Azar defended the administration’s actions, noting that more than a dozen leading drugmakers, including Pfizer Inc (PFE.N), Merck & Co (MRK.N) and Celgene Corp (CELG.O), had pledged to hold off on further price increases this year.
“They are seeing where this is going, they are seeing that we are ticking off the blueprint items one by one,” Azar said. “We are not dependent on the voluntary action of pharmaceutical companies. We are not counting on their goodwill or their altruism. … They’re just changing because they see that’s the future.”
Critics say the drug price pledges by major drugmakers are largely window dressing.
Since May, HHS has given Medicare Advantage health plans, which are administered by private-sector health insurers, new tools to lower prescription drug costs.
The agency’s Food and Drug Administration has unveiled a plan to boost the use of biosimilars, which are cheaper versions of expensive biotech medicines. Azar has directed the FDA to establish a working group to study how to import drugs safely from other countries if a drugmaker dramatically raises prices.
The actions have already sparked concerns. Last week, a leading group of rheumatologists met with Azar to discuss concerns over changes to Medicare Advantage that could force some patients to try a less effective, cheaper medication for a period of time before their health plan would cover a more expensive therapy.
HHS said Azar emphasized the agency’s interest in lowering drug prices but expressed openness to alleviating burdens that could be placed on physicians as a result of the new rule.
Azar said he spoke with Trump every few days, either in person or over the phone and that in every conversation, the president wanted to hear about progress on lowering prescription medicine costs.
“I have never once had a meeting or phone call with the president where we have not talked about drug pricing,” Azar said.
Reporting by Yasmeen Abutaleb; Editing by Michele Gershberg and Peter Cooney and David Gregorio
Our Standards:The Thomson Reuters Trust Principles.
Source link
The post U.S. health secretary says agency can eliminate drug rebates appeared first on Today News Stories.
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joannaarobinson · 6 years
Text
Conferences Need More Sharing
One of the strongest intangible attributes of a healthy conference is how much sharing takes place. Too often, competition and self-interest get in the way of sharing what’s most helpful.
Professions that deliver conference sessions with a high level of sharing – not diluted or generalized from the stage – are often in fields linked to prevention, healthcare, education and philanthropy. Protecting, curing, developing and caring are noble causes, and sharing the secret sauce is viewed as the right thing to do. Conversely, conferences that have a higher deal-making quotient tend to hold their cards closer to their chests.
Creating a Safe Environment for Sharing
Regardless of your industry, there are strategies conference organizers can adopt to help grow conference participant sharing, collaboration and co-creation.
Shift from speakers to facilitators of learning – Sharing is best achieved in small groups. To make this shift, speakers will need coaching on how to engage the participants in meaningful dialogue. They will need to focus less on delivering content and more on helping the learner uncover what the content means.
From a learning or facilitation-design perspective, interspersing content with conversations is most effective. An example of this is called chunking. Ten or so minutes of content is presented, followed by a provocative open-ended question that is used to frame small-group conversations. This cadence can be repeated numerous times to fill a 60- to 90-minute experience.
Think/Write/Share is a proven and effective strategy for helping create a safe space; especially for introverts.
Prime for trust – It’s important to build rapport before getting into deeper conversations. Easing attendees into sharing with one another should be done within the first few minutes of an experience. Ask them to introduce one another and share something novel (like first job, super power they wish they had) to set the tone for deeper sharing. Opening and getting buy-in with a presenter/attendee agreement can help establish expectations and ground rules for designing a safe space. Here’s an example of an agreement developed by Jeff Hurt, DES, executive vice president of education and engagement at Velvet Chainsaw Consulting. It helps set the tone for safe and collaborative learning experiences
Raise the sharing bar – With help from one of our most respected experts, Judith Glaser (organizational anthropologist and author), participants can engage in transformational – not transactional – conversations by:
Listening to connect first, not for opportunity
Putting others’ agenda ahead of your own by asking open-ended or tell-me- more type questions
Reinforcing success and progress.
The Proper Set-Up
Inclusive conversations are best achieved in groups of two to three participants. After initial conversations, two groups can be brought together to share and take the conversation to the next level. The most effective set-ups will be small cocktail rounds with four or five chairs. Alternatives include larger rounds of six, rectangular tables for six or even chairs rearranged by the participants. Sharing several small-group discussions with the larger group can be helpful to the process.
Leveling the Playing Field
Large companies, especially those in the pharmaceutical and financial services industries, tend to have greater restrictions on what they can and can’t share. Slide decks often need corporate approval. Professionals who work for these companies can share more in a small-group setting. We need to do a better job of designing learning experiences that offer all of our attendees the opportunity to share in small-group conversations.
Adapted from Dave’s Forward Thinking column in PCMA’s Convene. Reprinted with permission of Convene, the magazine of the Professional Convention Management Association. ©2018
How do you coach your speakers to make education sessions more participatory? What are some of the creative room sets you’ve used to encourage small-group conversations?
  The post Conferences Need More Sharing appeared first on Velvet Chainsaw.
from Event Planning Essentials https://velvetchainsaw.com/2018/04/26/conferences-need-more-sharing/ via http://www.rssmix.com/
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dorothydeaton62 · 7 years
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Gleostine Price Hike Undercuts Drugmakers’ Campaign to Deflect Blame for High Prices
WASHINGTON, Jan. 4, 2018 /PRNewswire-USNewswire/ — The Pharmaceutical Care Management Association (PCMA) released the following statement on the decision to raise Gleostine’s price from $50 to $768: “The drug company’s decision to raise the price of the forty-year-old drug Gleostine…
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http://ift.tt/2Cu5eMp
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omcik-blog · 7 years
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New Post has been published on OmCik
New Post has been published on http://omcik.com/drug-coverage-plans-battle-in-state-capitals-over-price-secrets/
Drug Coverage Plans Battle in State Capitals Over Price Secrets
(Photo: Thinkstock)
California is the biggest state so far to seek to pull back the curtain on pharmacy-benefits managers, as the industry aggressively tries to thwart a wider push for transparency.
Lawmakers in the General Assembly advanced a bill that would require more disclosures of discounts negotiated between the companies and drugmakers, but the measure is on hold after Gov. Jerry Brown’s administration last week asked for changes. Benefits managers have stymied several attempts at the state and federal levels to pry open their workings.
(Related: CVS Health Is Sued Over `Clawbacks’ of Prescription Drug Co-Pays)   
“There’s been huge push-back,” said the legislation’s sponsor, Jim Wood, a Democratic assemblyman from Northern California and dentist. “It really makes me more suspicious that there’s simply things they don’t want us to know.”
Politicians, pharmacies and patients say they understand little about how the $280 billion industry uses its clout to influence costs. The three largest pharmacy-benefit managers — Express Scripts Holding Co., UnitedHealth Group Inc.’s OptumRx, and CVS Health Corp. — process roughly 70% of U.S. prescriptions.
The fight is just one battle in a nationwide struggle between lawmakers who want more light on drug plans’ practices and the companies, who say that increased regulation will disrupt their ability to seek lower drug costs. In addition to state efforts, the U.S. Congress is also considering legislation.
“Those bills aren’t going anywhere,” said Mark Merritt, chief executive officer of the Pharmaceutical Care Management Association, the industry’s lobbying arm. “Every industry has numerous bills introduced by this or that member of Congress, whether you’re selling shoelaces or health care, that they don’t like. That’s just a normal cost of doing business.”
Poor Visibility
A Nevada measure signed in June by Republican Gov. Brian Sandoval requires pharmacy-benefit managers to reveal rebates they receive from insulin makers, how much of those rebates are passed on to insurers, and what they keep for themselves.
Diabetes affects 12% of Nevada’s population; another 38% are estimated to be at risk of the disease. At the same time, the price of insulin, a century-old treatment, has surged. Eli Lilly & Co.’s Humalog cost $21 a vial when it hit the market in 1996. Today, it has a list price of $275. Annual insulin sales worldwide exceed $20 billion.
Pharmacy-benefit managers say such rules deprive them of bargaining power they need to contain costs. The PCMA has blocked state efforts to regulate reimbursements, curb their ownership of mail-order pharmacies, and make them disclose financial conflicts.
(Image: Thinkstock)
In a six-page letter to Sandoval, the industry said the law would raise drug costs and likely be struck down by the courts for violating federal laws. Sandoval, a former state attorney general and federal judge, said when he signed the bill that it was unlikely to lose in court.
On Sept. 1, the Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America, two drug-industry lobbying groups, sued Nevada, hoping to keep the state from implementing the law, which they say violates patent rights and jeopardizes trade secrets.
Resistant to Regulation
Nevada isn’t alone. In July, Connecticut became the latest to ensure that pharmacists can tell patients the cheapest way to get their prescription drugs. Oklahoma has a law aimed at increasing clarity on pricing and giving pharmacists ways to dispute reimbursements.
But most states haven’t been able to make their efforts stick.
An Iowa PBM law was found by the U.S. Court of Appeals for the Eighth Circuit to run afoul of federal law preventing states from regulating employer-sponsored health plans. An Arkansas law was partially set aside on similar grounds. Laws in Maine and Washington, D.C., tagged pharmacy-benefits managers with a fiduciary duty to clients, but Maine’s law was eventually repealed, while Washington’s was struck down by courts.
“I still believe there’s a lot to be gained by cracking the PBMs’ practices,” said Kate Gainer, executive director of the Iowa Pharmacy Association, which represents more than 1,000 pharmacists and technicians. “I just don’t know how to get there.”
The California bill is expected to be reintroduced early next year. The governor’s office declined to comment.
The Federal Front
Transparency with drug-price negotiations is a “double-edged sword,” as some research has found revealing details could result in higher costs, Stephen Ubl, the chief executive officer of PhRMA, said in an interview. “So much of the transparency discussion that we see primarily at the state level is little more than veiled attempts at price controls.”
U.S. Rep. Doug Collins, a Republican from Georgia, has a bill that would make companies that contract with the U.S. government detail how they reimburse pharmacies for drugs. A bill from Senator Ron Wyden, the Oregon Democrat, would force disclosure of discounts.
Merritt, the PCMA chief, said that his industry works to educate lawmakers on how proposed regulations will increase health care and drug costs.
“We do it all the time, usually successfully,” he said. “The single most compelling thing we do, and do regularly, is show policy makers the real cost impact of the anti-PBM policies.”
Merritt said the better way to lower drug costs is for the U.S. Food and Drug Administration to increase approvals of generic and branded treatments — a strategy that the agency’s new leadership has embraced. Merritt said that companies don’t have to hire pharmacy-benefit managers, but do because of the savings they receive for their employees.
— Read Pharmacy Benefit Managers Have Changed on ThinkAdvisor.
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Drugmakers hike prices regardless of rebates, says PCMA
See on Scoop.it - Pharma & Medical Devices
Drugmakers' pricing strategies are not connected to the rebates and discounts they negotiate with pharmacy benefit managers, according to a new analysis from the Pharmaceutical Care Management Association. The study found that prices rise even when rebates are low, or non-existent. Some high-priced drugs like Sovaldi, a hepatitis C drug which initially cost $84,000, involved no rebates at all until other competitors came to market.
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Who Are Pharmacy Benefit Managers (PBMs) and How Do They Influence Drug Pricing?
New Post has been published on http://type2diabetestreatment.net/diabetes-mellitus/who-are-pharmacy-benefit-managers-pbms-and-how-do-they-influence-drug-pricing/
Who Are Pharmacy Benefit Managers (PBMs) and How Do They Influence Drug Pricing?
As part of our continuing coverage on the Insulin Affordability Crisis, in the Fall we “followed the money trail” to Pharmacy Benefit Managers, and we're now looking at them more closely. Special thanks to our correspondent Dan Fleshler for his help reporting this story.
If you’re looking for someone to yell at the next time you confront the skyrocketing price of insulin, think Pharmacy Benefit Managers, organizations that have finally come into the public limelight of late as middlemen who help determine how medicines are priced.
These big, powerful “PBMs” -- including Express Scripts, Optum RX and CVS Caremark -- negotiate drug prices on behalf of private corporations, health insurers, Medicare, private unions and other clients. Some are part of larger insurance companies, and most run mail-order pharmacies and have other functions as well.
A recent Wall Street Journal story explains that it’s the PBMs who are primarily responsible for establishing formularies, those all-important short lists of “preferred” drugs by insurance plans.
This takes place in a series of complex closed-door meetings, in which PBMs negotiate “rebates” and discounts from drugmakers, who are maneuvering to get an edge over the fierce competition to be included in those vital formularies that put their products at a huge advantage.
Now, PBMs have come under fire for pocketing the rebates to fatten their own bottom lines. The WSJ notes that “as U.S. drug prices rise, drugmakers are playing down their role, instead heaping blame on these middlemen who help determine how medicines are priced.” But the PBMs beg to differ, throwing the blame back on Big Pharma.
Clearly, there’s a lot that we don’t know about how these PBMs function, and just how much they manipulate the purse strings on drug pricing. We at DiabetesMine hope to dig into this more, and encourage the whole community to help “open the kimono” so we that patients and advocates can learn what we’re up against — maybe using the new hashtag #PBMsExposed?
We begin today with a brief exclusive Q&A with Mark Merritt, President of the PBM’s national trade association Pharmaceutical Care Managers Association (PCMA), and an analysis and Call to Action below.
Q&A with the Pharmaceutical Care Managers Association (PCMA)
DM) Insulin prices are skyrocketing and people with diabetes are very concerned. What is your message about PBMs’ role in the insulin pricing system?
MM) PBMs are putting pressure on drug companies to reduce insulin prices. If there are equally effective products and one PBM doesn’t feel like it’s getting a fair deal from a drug company, it puts pressure on that company to reduce the price.
DM) A lot of people are blaming PBMs for drug price increases, claiming that you pocket the rebates offered by drug manufacturers. So consumers don’t benefit from the rebates. What’s your response?
MM) We don’t have a direct relationship with consumers. A growing number of our clients prefer to have 100% of the rebates passed through to them. Then they decide how much gets passed on to consumers in health plans with point-of-sale discounts. It’s up to the clients. Any rebates that PBMs are able to keep are provided by clients as an incentive to encourage even bigger discounts.
DM) What should be done about insulin price inflation?
MM) It would be a lot easier if drug companies lowered the prices of their products. They’re responsible for more than 80%* of the costs.
(*Editor’s Note: that figure has not been substantiated)
DM) What’s your response to the American Diabetes Association’s call for greater transparency in the insulin pricing system?
MM) Transparency is a great thing if it helps the consumer. When people talk about transparency in the drug supply chain, it’s usually not about PBMs per se. The clients that hire PBMs need to be clear about what they want to be made public. The only kind of transparency that’s bad is one that inhibits the kind of confidential negotiations on rebates and discounts that each client needs to conduct with individual drug companies.
A Good Idea, Theoretically
Not sure we agree at all with that last comment by Merritt…
But it’s important to note that the drug pricing chain in America is quite complicated, and PBMs essentially play the role that governments play in the rest of the civilized world: bargaining hard with drug manufacturers in order to drive down consumer prices.
According to a report commissioned by the PCMA itself, PBMs:
save payers and patients an average of $941 a year because of the price concessions they negotiate
reduce the average net cost of a brand prescription from $350 to $268, and of that net cost, PBMs get just 4% or $12 for their services, while manufacturers receive 88% or $235(emphasis added)
Who knows if they’re fudging those numbers? Critics like the National Community Pharmacists Association have excoriated the report for some of its methodology. But even they don’t dispute that PBMs work hard to use the formulary system and other means to bring prices down, and many believe that even if PBMs are pocketing closer to 7% of net costs, the drug manufacturers still bear the lion’s share of responsibility for the high prices.
Who Really Benefits from Drug Rebates?
We consumers at the bottom of the pharma food chain certainly aren’t benefiting much. And the drugmakers and PBMs continue to point fingers at each other.
A recent Barron’s story states that, “Undisclosed drug-price markups… supply much of the PBM industry’s profits.”
Yet PBMs claim just the opposite. CVS Health Corp. spokeswoman Christine Cramer said that CVS… “gives the vast majority of rebates back to… [its] clients,” while Express Scripts also says that it returns about 90% of rebates to its customers.
But if PBMs are so great at kicking rebates back to their clients, why are some of the country’s biggest employers not happy with how PBMs do business? A coalition of large corporations called the Health Transformation Alliance is looking into changing their pharmacy-benefit contracts to eliminate the markups and instead charge “administrative fees.”
To date, it’s been impossible to accurately assess who’s the biggest winner because all of the contracts between PBMs and their clients are confidential.
A brand new report just published by the industry group PhRMA states that middlemen, or “non-manufacturer stakeholders” currently rake in upwards of 30% of the total money spent on prescription drugs in the U.S (!) This report presents powerful new evidence that PBM-negotiated rebates and discounts in fact result in higher prices for the end consumer.
Villains or Scapegoats?
But with such a complicated ecosystem, the question remains: are PBMs really the evil demons who bear a major responsibility for what is becoming a public health emergency?
Big Pharma says so. In fact, they openly admit to jacking up the initial list prices of medications because they know they’ll be forced to absorb rebates and discounts down the line.
For example, Jacob Riis, CEO of Novo, explained the prices they charge, when he (admirably) pledged to limit price increases to no more than 10% a year:
"As the rebates, discounts and price concessions got steeper, we were losing considerable revenue… So, we would continue to increase the list in an attempt to offset the increased rebates, discounts and price concessions to maintain a profitable and sustainable business."
Wait, are we supposed to believe it was PBMs and pricing concessions that prompted the nearly simultaneous, grotesquely high price hikes from the Big Three between 2010 to 2015, when Sanofi’s Lantus went up by 165%; Novo’s Levemir rose by 169%; and Lilly’s Humulin R U-500 soared by 325%?
Sorry, Dude, but it seems much more likely that all of you insulin manufacturers were trying to haul in as much profit as possible before cheaper generic insulin products (“biosimilars”) hit the market!
None of this means PBMs should be absolved of either responsibility or close scrutiny.
The American Diabetes Association and other advocates have wisely called for transparency in insulin pricing and for Congressional hearings on this matter.
Let’s face it, neither the insulin manufacturers nor the PBMs want the veil removed from their now-secret negotiations that set drug prices. Drug pricing is like a big black box... and transparency is EXACTLY what we all need. We need a better understanding of just how influential these PBMs really are, and how they can be swayed, if we ever want to affect change.
It may be the case that PBMs are saving us money, while Big Pharma is hiding behind them as scapegoats. But we can’t know that for sure until all the parties truly come out of the closet with the way this whole drug pricing racket works.
Dear Readers: please share any pertinent information you may have to help us out with #PBMsExposed?
Disclaimer: Content created by the Diabetes Mine team. For more details click here.
Disclaimer
This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines. For more information about Healthline's partnership with Diabetes Mine, please click here.
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