Safety-Net Hospitals Win With New Rule That Penalizes Drugmakers For Overcharging
Under a new Trump administration regulation, pharmaceutical companies face a fine of up to $5,000 for overcharging hospitals and clinics that qualify for the 340b program. Other news from the capital, a Department of Health and Human Services official dies. And Congress eyes insulin prices and HIV/AIDS legislation.
Stat:
Trump Administration OKs Rule Fining Pharma For Overcharging 'Safety Net' Hospitals
After years of bickering, thousands of so-called safety-net hospitals and clinics won a significant battle over the Trump administration, which agreed to implement a rule that would penalize drug makers for overcharging for their medicines. The rule is supposed to go into effect on Jan. 1. The rule, which had been delayed several times by the Trump administration, would fine drug makers up to $5,000 for each instance in which they “knowingly and intentionally” overcharge for their medicines. The companies must also reimburse providers for medicines that were purchased. The rule would also require drug makers to post ceiling prices on a government web site. (Silverman, 11/1)
Stat:
Dan Best, HHS Drug Pricing Adviser, Dies
Dan Best, the government’s top drug pricing adviser, has died, the Department of Health and Human Services announced Thursday afternoon. “It is with tremendous sadness that I learned of the passing of our friend and colleague,” HHS Secretary Alex Azar said in a statement. “I had the great privilege to know Dan Best for the past decade. He joined me here at HHS out of a desire to serve the American people by making healthcare more affordable.” (Swetlitz, 11/1)
Stat:
A New Bipartisan Plan To Bring Down Insulin Prices Centers On Drug Makers
A bipartisan group of more than 290 lawmakers is throwing its support behind some of the drug industry’s least favorite proposals for bringing down the cost of insulin. Parts of the report — released Thursday by the Congressional Diabetes Caucus — read like a laundry list of the drug industry’s worst fears: It pitches everything from legislation requiring drug companies to disclose how they set their prices to legislation that dings drug makers who can’t prove that a new version of insulin is more effective than an older one. (Florko, 11/1)
The Hill:
Congressional Report Says Insulin Market Benefits Drugmakers And Insurers, Not Patients
“Perverse” incentives in the insulin supply chain lead to artificially high prices, as well as limited competition in the markets, according to a bipartisan report released Thursday by two lawmakers. The report from Reps. Diana DeGette (D-Colo.) and Tom Reed (R-N.Y.), co-chairs of the Congressional Diabetes Caucus, took more than a year to complete and concluded that several factors drive insulin prices up, while forces that would typically drive prices down are “blunted.” (Hellmann, 11/1)
CQ:
Congress To Renew HIV/AIDS Effort As Is Despite Call For Change
Congress is on the verge of renewing one of the most successful and popular federal efforts on HIV/AIDS ever launched, but some say lawmakers are missing an opportunity to improve a program whose funding has been flat in the face of an evolving epidemic. While funding for global HIV/AIDS programs could see an increase for the first time since 2014, some advocates question whether the U.S. is approaching the fight against the disease in the right way. (Siddons, 11/2)
And from the Food and Drug Administration —
The Associated Press:
Cross Talk: Federal Agencies Clash On Cellphone Cancer Risk
Two U.S. government agencies are giving conflicting interpretations of a safety study on cellphone radiation: One says it causes cancer in rats. The other says there’s no reason for people to worry. No new research was issued Thursday. Instead, the National Toxicology Program dialed up its concerns about a link to heart and brain cancer from a study of male rats that was made public last winter. The Food and Drug Administration, which oversees cellphone safety, disagreed with the upgraded warning. And “these findings should not be applied to human cellphone usage,” said Dr. Jeffrey Shuren, FDA’s chief of radiological health. (Neergaard and Borenstein, 11/1)
The Hill:
First FDA Approved Cannabis-Based Drug Now Available By Prescription
The first cannabis-derived medication approved by the Food and Drug Administration is now available by prescription in every state, according to its manufacturer. Epidiolex, manufactured by GW Pharmaceuticals, is intended to treat seizures associated with two rare and severe forms of epilepsy that begin in childhood. The drug is made of cannabidiol (CBD), a component of marijuana that doesn’t give users a high. (Weixel, 11/1)