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Rx Drugs

January 08, 2019 | Daily News

Hospitals have revamped their lawsuit over repeated delays of the 340B ceiling price and penalties rule to ask that the federal D.C. district court make the Health Resources and Services Administration publish 340B ceiling prices on an HHS website by April -- which the agency has said it expects to do.

January 08, 2019 | Daily News

Hospitals are urging the federal D.C. district court not to give the federal government extra time to say how the court should move forward following its ruling that CMS lacked authority to cut reimbursement for 340B drugs in the 2018 outpatient hospital rule.

January 08, 2019 | Daily News

The House will consider on Tuesday (Jan. 8) legislation that would reform FDA’s process for regulating over-the-counter drugs and would reauthorize a number of HHS hazard preparedness programs, according to House Majority Leader Rep. Steny Hoyer’s (D-MD) daily schedule for Tuesday.

January 07, 2019 | Daily News

The Supreme Court on Monday (Jan. 7) heard oral arguments on a drug labeling case over whether drug maker Merck Sharp & Dohme Corp. should be held liable for injury to consumers even after FDA rejected the company’s proposal to include on its drug label warnings about potential fractures that could be caused by the osteoporosis drug Fosamax.

January 07, 2019 | Daily News

Congressional Democrats set the stage for 2019 by raising the stakes on legislation to control drug prices, and Republicans also are pushing bills to rein in drug prices.

January 07, 2019 | Daily News

States have proven to be innovators on prescription drug pricing policy so far, and policy watchers expect aggressive action in 2019.

January 07, 2019 | Daily News

House Democrats say they haven't yet determined whether to push for Medicare price negotiation of all drugs or just the expensive ones.

January 04, 2019 | Daily News

The pharmacy benefit manager (PBM) lobby is proposing FDA prohibit brand drug makers from filing citizen petitions, except for situations involving urgent health issues, in order to curb anticompetitive behavior by the brand-drug industry.

January 04, 2019 | Daily News

Cancer doctors were already working on a performance-based pay system with drug makers when HHS proposed indexing Part B drug prices to those in foreign countries, and the proposed International Pricing Index model lit a fire under those negotiations.

January 03, 2019 | Daily News

The Trump administration is expected to keep drug pricing on center stage in 2019 following a flurry of action last year. In 2018, the administration released a 44-page blueprint with ideas and questions on potential ways to lower drug prices and reduce out-of-pocket costs, and HHS, FDA and CMS proposed a torrent of regulations and notices.

January 03, 2019 | Daily News

Over the holidays and the first days of January, FDA Commissioner Scott Gottlieb issued a steady stream of tweets in a bid to answer stakeholders’ questions about which agency activities are on hold during the partial government shutdown, including user fee-related application reviews, certain medical and over-the-counter product reviews, and non-emergency work on certain biologic products.

January 03, 2019 | Daily News

As the government shutdown continues into its second week and Congress works to reach a spending deal, it is still unclear what will happen to a legislative package that would reform FDA’s over-the-counter (OTC) drug oversight and reauthorize a number of hazard preparedness programs at HHS.

January 03, 2019 | Daily News

The generic drug lobby sees expanding the use of international reference pricing as a potential opportunity to remedy low reimbursement rates for generic drugs, Association for Accessible Medicines President Chip Davis told Inside Health Policy.

January 02, 2019 | Daily News

Nearly two weeks into a government shutdown that has left 41 percent of FDA employees furloughed, an agency expert says the shutdown will disrupt FDA’s long-term planning because it will put off settling the question of how much funding the agency will receive from Congress in 2019.

January 02, 2019 | Daily News

It’s going to be more difficult for brand drug makers to get Congress to lower their share of seniors’ Part D donut-hole costs now that Democrats control the House, and the industry also exposed itself to billions of dollars in offsets while trying to roll back the donut hole policy in 2018, which Congress could use in 2019 to fund other health sector priorities.

December 31, 2018 | Daily News

The Trump administration’s Medicare Part B international price referencing demo has exposed chasms among groups that call themselves patient advocates, especially on the issues of patient access to medications and the use of value assessments to determine reimbursement levels.

December 31, 2018 | Daily News

A 2017 drug pricing transparency law in California -- while intended primarily to give payers advance notice of price hikes -- is providing a way for members of the public to also access some of the information, according to a Reuters story published Wednesday (Dec. 19).

December 28, 2018 | Daily News

A federal district court judge on Thursday (Dec. 27) sided with hospitals and said CMS overstepped its authority when cutting 340B drug reimbursement by almost 30 percent as part of the 2018 hospital outpatient pay rule, but the judge also asked for more information from both sides on how to proceed and avoid the “havoc” of vacating part of a budget- neutral rule.

December 28, 2018 | Daily News

In an attempt to encourage modernization of clinical trials, FDA revised and replaced its 11-year-old guidance outlining its current thinking on oncology endpoints based on context of use, FDA Commissioner Scott Gottlieb announced Wednesday (Dec. 19).

December 28, 2018 | Daily News

CMS is automating the system that determines whether drugs are properly classified in the Medicaid Drug Rebate Program as Congress gets closer to giving CMS the power to force drug reclassifications to recoup Medicaid rebates, according to a letter CMS sent earlier this year to Sen. Chuck Grassley (R-IA), who wrote the Medicaid-rebate bill.

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