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Rx Drugs

November 14, 2017 | Daily News

Certain off-campus hospital departments will be paid more by CMS for drugs purchased through the 340B system than through the main hospitals with which they are affiliated because those departments are not paid through the hospital Outpatient Perspective Payment System, and so are not affected by cuts to 340B reimbursement CMS intends to implement in 2018, a CMS official confirmed.

November 14, 2017 | Daily News

Medicare Advantage plans and commercial payers might follow CMS' lead in cutting pay to hospitals for drugs bought through the 340B drug discount program, lobbyists say.

November 14, 2017 | Daily News

House GOP lawmakers are expected to spearhead a bipartisan bill to block pay cuts for 340B drugs that may be introduced as early as this week, a hospital lobbyist said. Hospital lobbyists want to include a moratorium on cuts to reimbursement for 340B drugs in must-pass legislation before the end of the year.

November 14, 2017 | Daily News

House Energy & Commerce health subcommittee ranking Democrat Gene Green (TX) announced Monday (Nov. 13) that he will leave Congress at the end of 2018.

November 13, 2017 | Daily News

Hospitals are asking the federal D.C. district court to make CMS scrap its hospital reimbursement cuts for 340B drugs or at least suspend the cuts until the providers' lawsuit is resolved.

November 13, 2017 | Daily News

The White House is holding up HHS Secretary nominee Alex Azar’s advocacy for generic drug competition as evidence that he will, as President Donald Trump promised, rein in high drug prices.

November 13, 2017 | Daily News

A Senate committee aide told Inside Health Policy an agreement has been reached “between relevant parties” to address in separate legislation a controversial provision included in the 2018 Defense authorization bill that raised flags from FDA because it gave the Department of Defense (DOD) additional authority to authorize emergency use of medical products.

November 13, 2017 | Daily News

Chip Davis, the head of the generic drug trade association, cautions that if the business climate for generics does not improve, companies will consolidate or discontinue product lines -- potentially driving up prices and causing shortages.

November 13, 2017 | Daily News

While the validity of Allergan’s controversial deal with the Saint Regis tribe won’t be decided by the Patent Trial and Appeal Board (PTAB) until April 2018, a number of law firms are already shopping similar arrangements to clients, including tribes and public universities, and at least 20 to 30 companies are already penning such deals, an intellectual property expert tells Inside Health Policy.

November 13, 2017 | Daily News

In the wake of the controversy surrounding Allergan’s decision to lease its patents for Restasis to a Native American tribe, the head of the congressional subcommittee with jurisdiction over the inter partes review process is writing legislation aimed at reforming the process.

November 13, 2017 | Daily News

President Donald Trump announced Monday (Nov. 13) via tweet the nomination of Alex Azar to lead HHS, saying the former Lilly president "will be a star for better healthcare and lower drug prices!"

November 10, 2017 | Daily News

Five former FDA commissioners say a controversial bill that would allow the Department of Defense (DOD) to approve certain drugs and medical devices for emergency use by those in the military would put soldiers at risk, given, the former FDA heads allege, DOD lacks the resources and knowledge needed to evaluate and ensure therapies' safety and efficacy.

November 10, 2017 | Daily News

The Medicare and Medicaid drug-coverage policies that some now view as contributing to drug price increases have been in place for many years, but it took the hepatitis C drug Sovaldi to spark the explosion in prices, attendees and presenters at a Federal Trade Commission workshop on the prescription drug market said Wednesday (Nov. 8).

November 10, 2017 | Daily News

The hospital, health system pharmacist and anesthesiologist lobbies, among others, are calling on Congress to consider legislative fixes that would help the United States more systematically prepare for drug shortages.

November 10, 2017 | Daily News

FDA released a new internal policy guide Thursday (Nov. 9) directing agency staff to prioritize review of all generic applications ready to file when the 180-day first-to-file exclusivity runs out.

November 10, 2017 | Daily News

Association For Accessible Medicines President and CEO Chip Davis argued Monday (Nov. 6) that generic drugs provide a solution to patients' nonadherence with brand prescription drug regimes, which the trade group head asserted kills more each week than the opioid epidemic.

November 10, 2017 | Daily News

The Government Accountability Office criticized CMS’ approach to opioid prescribing oversight under Medicare Part D and recommended the agency expand that oversight to prevent opioid overuse in the program.

November 09, 2017 | Daily News

FDA Commissioner Scott Gottlieb on Tuesday (Nov. 7) threw his support behind a proposal that would allow FDA to maintain its approval authority over products developed for the war fighter while also fulfilling the Department of Defense's need for battlefield drugs and devices to be approved faster through expedited pathways.

November 09, 2017 | Daily News

Drug makers that refuse to comply with possible future requests from the FDA to withdraw opioids from the market could face administrative law judge proceedings, agency head Scott Gottlieb said during The Hill's “America's Opioid Epidemic: Strategies for Prevention” event on Tuesday (Nov. 7).

November 09, 2017 | Daily News

House Energy & Commerce Committee leaders are urging the Government Accountability Office (GAO) to conduct investigations into how well federal agencies understand the epidemiology of superbugs -- strains of bacteria that are resistant to antibiotics -- and they use predictive models to inform their decision-making, especially when determining infectious disease outbreaks.

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