WASHINGTON — Policy experts and state officials asked Congress for help in stopping sham facilities from exploiting people with addiction issues on the taxpayer’s dime.
Help States Deter ‘Patient Brokering,’ Lawmakers Told
“Brokering” of addiction treatment patients is becoming a nationwide problem, but there are actions the federal government could take to help states and localities crack down on this activity, experts told lawmakers.
“In July 2016, our office formed a task force to crack down on this,” Dave Aronberg, the state’s attorney for Palm Beach County, Florida, said at Tuesday’s House Oversight and Investigations Subcommittee hearing. He noted that the task force has arrested 41 people and scored 10 convictions so far. “But we can’t fix this problem alone.”
Because treating addiction can be a lucrative business, some companies that operate in Florida and purport to treat substance abuse patients will hire people as marketers or call center operators; their job is to encourage patients to come in from out of state to receive treatment at an addiction center, or to stay at a “sober house” to integrate back into society once they have finished treatment, Aronberg explained.
Often, however, these facilities provide little or no addiction treatment, and the sober houses are more like flophouses and don’t provide the help they advertise, but the marketers get paid commissions or kickbacks for each person they sign up. They lure patients with offers of free travel, free rent, and other benefits.
FDA Panel Gives Thumbs Down to Spine Device
An FDA advisory committee voted 5-8 on Tuesday, with one abstention, against recommending approval of the Barricaid prosthesis for partial anulus replacement in patients with herniated discs.
“There was a high rate of breakage of the device, a high rate of migration, and [there was] the unknown nature of [some endplate] lesions,” said Eli Baron, MD, of the Cedars Sinai Spine Center in Los Angeles, a member of the FDA’s Orthopaedic and Rehabilitation Devices Panel. Many of the users of the device would be younger patients — “most in their 30s and 40s, and we don’t know what will happen down the line.” He voted that the risks of the Barricaid device, which is manufactured by Intrinsic Therapeutics, outweighed its benefits.
But committee member Ty Subhawong, MD, of the University of Miami, disagreed. “[The device is] reasonably safe, and I think the major concerns were centered around the endplate lesions, and while there were some theoretical concerns about harbingers of device failure …. the number of lesions observed was sufficient to reassure me that there is nothing catastrophic about these devices,” said Subhawong, who voted in favor of recommending approval. He added, however, that a post-approval study would be a good idea.
Why Are Drug Prices So High? Let Us Count the Ways
There was one thing several witnesses at a House hearing on the drug supply chain and high drug prices had in common: the ability to point fingers.
“Three PBMs [pharmacy benefit management firms] buy on behalf of over 70% of the prescriptions in this country … They exert significant cost pressure to keep spending and prices in check,” Lori Reilly, executive vice president for policy, research, and membership at the Pharmaceutical Research and Manufacturers of America, said during Wednesday’s House Energy & Commerce Health Subcommittee hearing. “One of the ways they do that is to extract significant discounts and rebates from pharmaceutical manufacturers … They now total over $100 billion a year. Unfortunately, many times those discounts and rebates are captured by intermediaries and don’t make their way back to patients.”
That’s not really how it works, according to Mark Merritt, president and CEO of the Pharmaceutical Care Management Association, a trade group for PBMs. “As always, pricing decisions in any industry are driven by supply and demand and competition, not supply chains,” he said. “Prices are set exclusively by drug companies with zero input from anybody else in the supply chain, including PBMs … Some drugmakers have tried to blame their own pricing decisions on the supply chain, but this makes little sense.”
Senate Committee Evaluates Impact of Cures Act on Mental Health, Opioids Epidemic
Money was the core focus of a Senate hearing on the mental health provisions of the 21st Century Cures Act 1 year after the bill’s passage.
Best known for its goal of speeding the development and approval of new treatments for life-threatening illnesses, the Cures Act included lesser-known provisions such as a substantial overhaul of the nation’s mental health system.
At the hearing Wednesday, Democrats asked whether the mental health programs in the Cures bill would be fully funded. Sen. Chris Murphy (D-Conn.) pointed out that the current appropriation bill for the Department of Labor and HHS does not yet include monies for the new programs.
“Congress has an awful habit of talking a really good game on mental health and addiction, but then never being able to meet our rhetoric with resources,” he said.
Some committee members also worried that the $1 billion in state grants to respond to the opioid epidemic wasn’t being dispensed fairly. Sen. Sheldon Whitehouse (D-R.I.), whose state is among the worst hit by the epidemic, said he hoped the process for the remaining $500 million (the first $500 million has already been distributed) would “more accurately address the high-impact states.”
FDA Approves First Drug for Rare Vasculitis
The FDA expanded the indication for mepolizumab (Nucala) to treatment of eosinophilic granulomatosis with polyangiitis (EGPA) in adults, making it the first drug specifically approved for that disease.
EGPA, formerly known as Churg-Strauss syndrome, is one of the rarest systemic vasculitis conditions, affecting 10.7 to 14 per million adults. The autoimmune condition causes inflammation in small- to medium-sized blood vessels and is often characterized by late-onset asthma, blood eosinophilia, and skin nodules or purpura.
Mepolizumab, a monoclonal antibody that binds to interleukin-5 to keep it from binding to receptors on the surface of eosinophils, had previously been approved for severe eosinophilic asthma.
On Monday through Wednesday, the Physician-focused Payment Technical Advisory Committee will discuss and vote on proposed alternative payment models.