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Drug Pricing

June 12, 2018 | Daily News

FDA finalized Tuesday (Jun 12) two guidances clarifying FDA’s rules for communicating health care economic information with payers and for promoting information that is consistent with, but absent from, a product’s label.

June 12, 2018 | Daily News

HHS Secretary Alex Azar told the Senate health committee Tuesday (June 12) that he believes the administration has the authority to mandate disclosure of list prices in direct-to-consumer ads, but added that he welcomes congressional action on the issue given he expects the idea will be challenged in court.

June 12, 2018 | Daily News

Rep. Doris Matsui (D-CA) on Tuesday (June 12) introduced a provider-friendly bill to reform the 340B drug discount program -- including explicitly laying out a purpose for the 340B program that says hospitals do not necessarily have to forward drug discounts to patients and reversing the CMS cut to hospitals' Medicare reimbursement for 340B drugs.

June 08, 2018 | Daily News

FDA has told sponsors of a closely watched Risk Evaluation and Mitigation Strategies reform bill that while it supports the goal of the legislation, it worries that it could actually allow further gaming intended to delay generic competition.

June 06, 2018 | Daily News

The more than 800 generics approved by FDA in 2017 have saved $11.8 billion for drug purchasers, according to a new FDA report released Tuesday (June 5).

June 06, 2018 | Daily News

CMS will announce as early as next week an agreement to lower the cash price of insulin for beneficiaries who choose to buy the drugs without their insurance, according to a source familiar with plan.

June 06, 2018 | Daily News

FDA is weighing how to further incentivize testing of previously approved mass-marketed drugs to treat rare diseases, despite the fact that a legislative proposal to do just that has been fiercely contested by drug pricing advocates.

June 06, 2018 | Daily News

In a change of tone for HHS, CMS on Tuesday (June 5) highlighted findings in the Medicare trustees annual report that showed spending growth has slowed in the Part D retail drug benefit.

June 05, 2018 | Daily News

Senate Democrats will use the month of August to work on legislation to lower health care costs, including drug prices, according to Minority Leader Charles Schumer (D-NY), who says that Majority Leader Mitch McConnell (R-KY) handed Democrats a "wonderful, great opportunity" with his decision to scrap the recess period that parties typically use to campaign for the mid-term elections.

June 05, 2018 | Daily News

The Senate health committee will hold a hearing on the 340B drug discount program with Health Resources and Services Administration personnel on June 19, the committee announced.

June 05, 2018 | Daily News

The Senate Judiciary Committee will begin marking up the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act Thursday (June 7), the committee announced Tuesday (June 5).

June 04, 2018 | Daily News

FDA announced Monday (June 4) evening approval of the first biosimilar to Neulasta (pegfilgrastim), which reduces the chance of infection for cancer patients undergoing chemotherapy.

June 04, 2018 | Daily News

Total Part D reimbursement for brand-name drugs increased 77 percent from 2011 to 2015, even though seniors filled 17 percent fewer prescriptions over the same period, according to the HHS Office of Inspector General.

June 04, 2018 | Daily News

The administration would be wise to test drug price-cutting policies on ophthalmologists and rheumatologists before expanding demonstrations to cover more politically powerful cancer doctors, health care analysts say, though ophthalmologists and rheumatologists stress that they helped kill the Obama administration’s proposed Part B demo.

June 01, 2018 | Daily News

The Health Resources and Services Administration signaled Friday (June 1) that it plans to make additional changes to the 340B program -- including changes affecting providers.

June 01, 2018 | Daily News

The Health Resources and Services Administration is pushing back the effective date of 340B ceiling prices and penalties requirements until July 2019, according to a final rule released Friday (June 1) that again tied the delay to a need for more rulemaking and formulation of 340B policies surrounding the president’s drug pricing plan.

May 31, 2018 | Daily News

The Community Oncology Alliance is suing the Trump administration for continuing to apply sequestration pay cuts to Medicare reimbursement for doctor-administered drugs.

May 31, 2018 | Daily News

Rheumatologists are putting a hold on designing a provider-pay model that removes rebate-driven middlemen in Medicare Part D while the doctors deal with the administration’s proposals to move Part B drugs to Part D and to revive the Competitive Acquisition Program, according to Madelaine Feldman, vice president of the Council of State Rheumatology Organizations.

May 31, 2018 | Daily News

FDA released long awaited guidance Thursday (May 31) outlining when the agency will waive the requirement that brands and generics share a single safety system, but those following the issue say FDA can only do so much without a change in statute.

May 30, 2018 | Daily News

President Donald Trump promised Wednesday (May 30) that drug companies would voluntarily lower drug prices in two weeks -- a comment that caught lobbyists off guard, and left some cautioning against taking Trump’s comments literally.

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