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President Biden touted the potential cost savings of Medicare‘s first-ever price negotiations for widely used prescription drugs on Tuesday as he struggles to convince Americans that he’s improved their lives as he runs for reelection...The negotiation process was authorized under the Inflation Reduction Act...Any lower prices won’t take effect for three years, and the path forward could be further complicated by litigation from drugmakers and heavy criticism from Republicans...READ MORE

The agency will kick off discussions on how it will negotiate Medicare drug prices in the spring and publish the first 10 drugs selected by Sept. 1, 2023...The U.S. Department of Health and Human Services...released its timeline for negotiating prices on an initial tranche of Medicare drugs, a new power granted the agency by last year’s Inflation Reduction Act...Under the law, Medicare can negotiate prices for top-selling drugs that have no competition, starting with 10 in 2026 and rising to a total of 60 by 2029. But the law didn’t fully detail the process by which that will happen...READ MORE

A new report finds that 1,216 pharmaceuticals increased their prices past the inflation rate of 8.5% from July 2021 to July 2022, with an average hike of 31.6%...The report and a second report on price trends released...by the Department of Health and Human Services underline how a new provision in the Inflation Reduction Act—an inflationary cap on Part D costs—will affect prices right as the cap is implemented Oct. 1...READ MORE

...Republican and Democratic senators met with the chamber's parliamentarian to discuss whether the bill's proposal for Medicare to negotiate the price of prescription drugs with manufacturers has a direct impact on government spending or tax revenue, as reconciliation rules require...But these are not negotiations. They're price controls. The bill's text sets maximum prices that the government will pay — and threatens confiscatory taxes for drug companies that refuse to comply...it will mean that fewer cutting-edge drugs are available to American patients...price controls on prescription drugs are unnecessary. Even as the price of just about everything else in our economy has soared in the past year, drug prices have been relatively flat...If lawmakers want to reduce patient drug costs meaningfully, they should train their focus on pharmacy benefit managers...PBMs keep a cut of the savings they extract and send another cut to the insurer, which may use that cut to lower overall premiums...READ MORE

Four people were injured and one woman was killed in a mass shooting Wednesday in a downtown Atlanta medical office waiting room, local law enforcement said...The suspected gunman, a 24-year-old man, entered Midtown medical building and shot the victims around noon, police said. He escaped in a stolen vehicle, kicking off a manhunt before he was taken into custody without incident later that evening, they said...The victim who was killed has been identified as Amy St. Pierre, a 39-year-old who worked for the Centers for Disease Control and Prevention, according to a statement from the agency...READ MORE

In a development in what’s being billed as one of the largest healthcare fraud schemes ever, a federal grand jury yesterday convicted the owner of a laboratory that performs sophisticated genetic tests of bilking Medicare out of hundreds of millions of dollars...The crime involved telemarketers allegedly lying to Medicare recipients by ensuring them that they were covered for expensive genetic cancer tests...Telemedicine physicians allegedly approved the tests even though they hadn’t treated the patients and, in many cases, hadn’t even spoken to them. The DOJ said dozens of suspects might be involved in the scheme in which $463 million in questionable claims were made to Medicare...READ MORE

A mother and her daughter have been indicted on health care fraud charges after they allegedly received millions in false Medicare claims...Mirosis Gonzalez...and her daughter Berioska Sosa...used the pharmacy they owned and operated, Aviva Care Pharmacy, to submit over $12 million in false Medicare claims...received payments totaling about $8.4 million...The marketing and telemedicine companies recruited patients and referred Medicare beneficiaries and doctors’ orders and prescriptions to Aviva Care Pharmacy and were paid kickbacks and bribes in return...the companies sent Aviva orders, which the pharmacy accepted...“without considering medical necessity or Medicare reimbursement eligibility.”...They are accused of disguising the kickbacks and bribes they paid to these companies by saying the payments were for marketing and other services...READ MORE</strong>

The Biden administration rolled out new guidance to drugmakers for meeting a new requirement to dole out rebates if their prices on Medicare Parts B and D go above inflation...The guidance...implements a key part of the Inflation Reduction Act passed last year. Drug companies had to start paying rebates for raising prices past inflation back in January, with the amounts going back to Medicare...“We are fighting to rein in the excessive cost of skyrocketing prescription drug prices, and now drug companies that increase their prices faster than the rate of inflation will have to pay rebates back to the Medicare Trust Fund,” said HHS Secretary Xavier Becerra in a statement...READ MORE

The reference to “maximum fair price” in the act bodes poorly for manufacturers and suggests more of a take-it-or-leave-it situation rather than a negotiation where clinical evidence would be the prevailing factor in determining price...Now that the dust has settled over enactment of the Inflation Reduction Act, leaders across the industry should be taking stock and assessing how the law will impact their product portfolios and the bottom line. Although several open questions remain, pharmaceutical manufacturers can take actions to best position their organizations to either benefit from — or mitigate repercussions — of the new law. Specifically, executives should lay out strategies for addressing revenue optimization, evidence development planning and portfolio optimization...READ MORE

The main U.S. drug lobby has said it will push back against the legislation, which includes policies that drugmakers have opposed for decades...The pharmaceutical industry is gearing up to minimize the effect of major drug legislation passed by Congress on Friday, the first time in many years lawmakers have overcome the drug lobby’s opposition to limits on their pricing power...the House of Representatives passed the Inflation Reduction Act in a 220-207 party-line vote, sending the bill to President Joe Biden...The bill would allow Medicare to negotiate prices on up to 60 drugs by 2029...The pharma industry spent heavily to lobby against the bill and, after decades of forestalling action to curtail the industry’s pricing power in the U.S., its main lobbying group signaled the fight would continue...READ MORE