Business
Senators Back Bill to Tackle Big Pharma’s Rocketing Prescription Drug Prices
The MEPA Act would scale back incentives to jack up prescription drug prices at pharmacies.
Built-in structures to incentivize jacking up drug prices in pharmacies, and prey on seniors, could soon be whittled down.
Sens. Maggie Hassan (D-NH) and Bob Menendez (D-N.J.) were among those who voted Wednesday to advance a bipartisan bill she personally helped develop to reduce the rocketing cost of prescription drugs and the way pharmacy managers benefit from rising drug prices.
The Modernizing and Ensuring PBM Accountability (MEPA) Act, which passed the Finance Committee July 26 on a bipartisan basis, reduces the cost incentive for pharmacy benefit managers (PBMs) to prioritize more expensive drugs because they receive higher payouts for higher priced drugs.
Drugmakers say that the rising rebates they must pay PBMs are forcing them to jack up prescription drug prices. According to a recent analysis, drugmaker rebates to PBMs increased from $39.7 billion in 2012 to $89.5 billion in 2016, partially offsetting list prescription drug price increases. PBMs say, however, that they have been passing along a larger share of the money to insurers.
“Last year, we took on Big Pharma by giving Medicare the ability to negotiate drug prices, and we must continue to stand up to the health care industry and help people afford the medications that they need,” said Senator Hassan. “This bipartisan legislation will ensure that pharmacy benefit managers don’t push people to more expensive drugs just so that they can get a larger payout, saving seniors their hard-earned money while also saving taxpayer dollars.”
HIV drugmaker Gilead Sciences was slammed for its PBM Express Scripts because it jacked up the prices of its lifesaving hepatitis C cures Sovaldi and Harvoni. But Gilead later changed its tune and joined a chorus of drugmakers—turning on PBMs. “I have never met, in this entire experience, a PBM or a payer outside of the Medicaid segment that preferred a price of $50,000 over $75,000 and a rebate back to them,” Jim Meyers, executive VP of worldwide commercial operations for Gilead told Bloomberg in 2017. “We have a system that’s incentivized upon rebate revenue.”
What Would Change Under The Modernizing and Ensuring PBM Accountability Act
The bill would lower prescription drug costs and is estimated to save $1.7 billion in taxpayer dollars. It makes a few adjustments to common PBM practices and transparency requirements under Medicare Part D, which the Senator outlined as follows:
- PBMs often prioritize coverage of more expensive drugs because part of their compensation is calculated through the list prices of drugs. This legislation will break the link between drug prices and how much pharmacy benefit managers are paid, so there is no longer a financial incentive for these companies to push patients to buy more expensive medication.
- This legislation will ban the practice of “spread pricing” in Medicaid, in which pharmacy benefit managers negotiate a lower price with a pharmacy but charge a higher price to the health plan, pocketing the difference.
- The legislation also includes a bipartisan measure that Senator Hassan led to ensure that pharmacy benefit managers report transparently on how they price low-cost generics and biosimilar medications, allowing more visibility into whether people can easily access these generics.
Sen. Menendez (D-N.J.), a senior member of the U.S. Senate Committee on Finance, said the Modernizing and Ensuring PBM Accountability (MEPA) Act includes his own inclusion, the Patients Before Middlemen (PBM) Act, joined by Marsha Blackburn (R-TN), alongside Senate Finance Chairman Ron Wyden (D-OR), Senate Finance Ranking Member Mike Crapo (R-ID), Sen. Jon Tester (D-MN), and Sen. Roger Marshall (R-KS).
“For too long, PBMs have held a vise grip over the prescription drug supply chain—price gouging hardworking families and seniors alike. Through the current incentive structure, whereby they turn a profit as a percentage of the list price of a prescription, PBMs wield their influence to have health insurers cover more and more expensive drugs—even when cheaper options are available,” said Sen. Menendez. “My Patients Before Middlemen Act, which I’ve introduced alongside Senators Blackburn, Wyden, Crapo, Marshall, and Tester, would replace the complicated scheme of opaque rebates and administrative charges with a flat fee—one that is negotiated before entering into a contract. By delinking PBM compensation from drug prices, we help lower prescription drug costs for Medicare Part D beneficiaries and better align incentives in the market. Our bipartisan Patients Before Middlemen (“PBM”) Act would curb the biggest abuses in the PBM industry today.”
Multiple factors impact skyrocketing drug prices—and when it’s a lifesaving drug, people will pay anything. Between 2007 and 2018, the cost of some insulin products increased by over 200%, according to a study published in 2022 in The Lancet. Most famously, “Pharma Bro” Martin Shkreli jacked up the price of lifesaving antiparasitic medication Daraprim, for people with HIV, in 2015 by 4000%. He also allegedly created an elaborate scheme to deny the entry of generic drug competition from getting a piece of the pie.
New Mexico regulators fined a cannabis operator nearly $300,000 and revoked its license after the company allegedly created fake reports in the state’s traceability software.
The New Mexico Cannabis Control Division (CCD) accused marijuana manufacturer and retailer Golden Roots of 11 violations, according to Albuquerque Business First.
Golden Roots operates the The Cannabis Revolution Dispensary.
The majority of the violations are related to the Albuquerque company’s improper use of BioTrack, which has been New Mexico’s track-and-trace vendor since 2015.
The CCD alleges Golden Roots reported marijuana production only two months after it had received its vertically integrated license, according to Albuquerque Business First.
Because cannabis takes longer than two months to be cultivated, the CCD was suspicious of the report.
After inspecting the company’s premises, the CCD alleged Golden Roots reported cultivation, transportation and sales in BioTrack but wasn’t able to provide officers who inspected the site evidence that the operator was cultivating cannabis.
In April, the CCD revoked Golden Roots’ license and issued a $10,000 fine, according to the news outlet.
The company requested a hearing, which the regulator scheduled for Sept. 1.
At the hearing, the CCD testified that the company’s dried-cannabis weights in BioTrack were suspicious because they didn’t seem to accurately reflect how much weight marijuana loses as it dries.
Company employees also poorly accounted for why they were making adjustments in the system of up to 24 pounds of cannabis, making comments such as “bad” or “mistake” in the software, Albuquerque Business First reported.
Golden Roots was fined $298,972.05 – the amount regulators allege the company made selling products that weren’t properly accounted for in BioTrack.
The CCD has been cracking down on cannabis operators accused of selling products procured from out-of-state or not grown legally:
- Regulators alleged in August that Albuquerque dispensary Sawmill Sweet Leaf sold out-of-state products and didn’t have a license for extraction.
- Paradise Exotics Distro lost its license in July after regulators alleged the company sold products made in California.
Golden Roots was the first alleged rulebreaker in New Mexico to be asked to pay a large fine.
Source: https://mjbizdaily.com/new-mexico-cannabis-operator-fined-loses-license-for-alleged-biotrack-fraud/
Four marijuana companies, including a multistate operator, have filed a lawsuit against U.S. Attorney General Merrick Garland in which they allege the federal MJ prohibition under the Controlled Substances Act is no longer constitutional.
According to the complaint, filed Thursday in U.S. District Court in Massachusetts, retailer Canna Provisions, Treevit delivery service CEO Gyasi Sellers, cultivator Wiseacre Farm and MSO Verano Holdings Corp. are all harmed by “the federal government’s unconstitutional ban on cultivating, manufacturing, distributing, or possessing intrastate marijuana.”
Verano is headquartered in Chicago but has operations in Massachusetts; the other three operators are based in Massachusetts.
The lawsuit seeks a ruling that the “Controlled Substances Act is unconstitutional as applied to the intrastate cultivation, manufacture, possession, and distribution of marijuana pursuant to state law.”
The companies want the case to go before the U.S. Supreme Court.
They hired prominent law firm Boies Schiller Flexner to represent them.
The New York-based firm’s principal is David Boies, whose former clients include Microsoft, former presidential candidate Al Gore and Elizabeth Holmes’ disgraced startup Theranos.
Similar challenges to the federal Controlled Substances Act (CSA) have failed.
One such challenge led to a landmark Supreme Court decision in 2005.
In Gonzalez vs. Raich, the highest court in the United States ruled in a 6-3 decision that the commerce clause of the U.S. Constitution gave Congress the power to outlaw marijuana federally, even though state laws allow the cultivation and sale of cannabis.
In the 18 years since that ruling, 23 states and the District of Columbia have legalized adult-use marijuana and the federal government has allowed a multibillion-dollar cannabis industry to thrive.
Since both Congress and the U.S. Department of Justice, currently headed by Garland, have declined to intervene in state-licensed marijuana markets, the key facts that led to the Supreme Court’s 2005 ruling “no longer apply,” Boies said in a statement Thursday.
“The Supreme Court has since made clear that the federal government lacks the authority to regulate purely intrastate commerce,” Boies said.
“Moreover, the facts on which those precedents are based are no longer true.”
Verano President Darren Weiss said in a statement the company is “prepared to bring this case all the way to the Supreme Court in order to align federal law with how Congress has acted for years.”
While the Biden administration’s push to reschedule marijuana would help solve marijuana operators’ federal tax woes, neither rescheduling nor modest Congressional reforms such as the SAFER Banking Act “solve the fundamental issue,” Weiss added.
“The application of the CSA to lawful state-run cannabis business is an unconstitutional overreach on state sovereignty that has led to decades of harm, failed businesses, lost jobs, and unsafe working conditions.”
Alabama regulators are targeting Dec. 1 to award the first batch of medical cannabis business licenses after the agency’s first two attempts were scrapped because of scoring errors and litigation.
The first licenses will be awarded to individual cultivators, delivery providers, processors, dispensaries and state testing labs, according to the Alabama Medical Cannabis Commission (AMCC).
Then, on Dec. 12, the AMCC will award licenses for vertically integrated operations, a designation set primarily for multistate operators.
Licenses are expected to be handed out 28 days after they have been awarded, so MMJ production could begin in early January, according to the Alabama Daily News.
That means MMJ products could be available for patients around early March, an AMCC spokesperson told the media outlet.
Regulators initially awarded 21 business licenses in June, only to void them after applicants alleged inconsistencies with how the applications were scored.
Then, in August, the state awarded 24 different licenses – 19 went to June recipients – only to reverse themselves again and scratch those licenses after spurned applicants filed lawsuits.
A state judge dismissed a lawsuit filed by Chicago-based MSO Verano Holdings Corp., but another lawsuit is pending.
Source: https://mjbizdaily.com/alabama-plans-to-award-medical-cannabis-licenses-dec-1/
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