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Rx Drugs

February 08, 2018 | Daily News

HHS Secretary Alex Azar is about to release a plan to curb rising drug prices that involves Medicare Part D and Medicaid policies focused on shining a light on drug-channel middlemen and lowering beneficiary drug spending at the pharmacy counter, lobbyists say.

February 07, 2018 | Daily News

The bipartisan budget deal announced by Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Charles Schumer (D-NY) on Wednesday (Feb. 7) includes four additional years of funding for the Children's Health Insurance Program; funding for community health centers, teaching health centers and the National Health Service Corps; repeal of the therapy caps; a delay of the Medicaid Disproportionate Share Hospital pay cuts and funding for other so-called Medicare extenders, according to a Democratic overview of the deal and draft bill language obtained by Inside Health Policy.

February 07, 2018 | Daily News

Drug lobbyists and policy analysts say the Senate budget deal includes a Medicare Part D offset that the brand drug industry strongly opposes, but they say the details of the measures are unclear because they are written in a way that is difficult to decipher.

February 07, 2018 | Daily News

The draft budget deal announced by Senate leaders Wednesday (Feb. 7) includes a provision that would for the first time allow hospitals and doctors' offices to share Medicare claims data with standalone Part D prescription drug plans.

February 07, 2018 | Daily News

Senate Majority Leader Mitch McConnell (R-KY) announced a budget deal with Senate Democrats on Wednesday (Feb. 7) that includes $6 billion to fight the opioid and mental health crises, and raises non-defense discretionary spending.

February 07, 2018 | Daily News

FDA is in talks with Congress -- and has had internal agency discussions -- to assess the agency’s authority to require all immediate-release (IR) formulations of opioids be packaged in three-, seven- or 14-day blister packs, FDA Commissioner Scott Gottlieb told stakeholders during a Tuesday (Feb. 6) event held by the Alliance for a Stronger FDA.

February 07, 2018 | Daily News

FDA Commissioner Scott Gottlieb touted the potential for FDA to use its Sentinel System to study the long-term effects and prescribing of opioids and how long-term use can lead to addiction.

February 07, 2018 | Daily News

A coalition of health care stakeholders representing distributors, caregivers, mental health advocates, pharmacists, patient education advocates and physician assistants have formed Allied Against Opioid Abuse (AAOA), a coalition aimed at educating health care providers, pharmacists and the public about responsible prescription opioid prescribing and use.

February 06, 2018 | Daily News

House Energy & Commerce Chair Greg Walden (R-OR) told Inside Health Policy Tuesday (Feb. 6) he does not believe House leadership will heed calls from sponsors of a pending Right to Try bill to bypass the E&C committee and send the Senate-passed bill directly to the House floor.

February 06, 2018 | Daily News

Group Purchasing Organization Vizient expects drug prices to increase 7.35 percent from July 2018 through June 2019, with the most substantial price hikes occurring in disease-modifying anti-rheumatic agents, like Remicade, Humira and Enbrel.

February 05, 2018 | Daily News

Both sides of the debate over the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act are throwing money into advertising, with the American Conservative Union arguing against the bill and the new political wing of Patients for Affordable Drugs pushing lawmakers to support it.

February 05, 2018 | Daily News

FDA Commissioner Scott Gottlieb signaled the agency may publicly announce when it plans to issue or revise product-specific guidance for complex generics, in line with a proposal from Congress' investigative arm.

February 02, 2018 | Daily News

The top Republicans on the House Energy & Commerce Committee are requesting FDA create a contingency plan by next month to deal with the possibility of a heparin shortage.

February 01, 2018 | Daily News

CMS proposed Thursday (Feb. 1) to reinterpret the law to let Medicare Advantage plans offer supplemental benefits that include such services as non-skilled respite home care, portable wheelchair ramps and other devices to assist disabled beneficiaries.

February 01, 2018 | Daily News

Almost 300 House lawmakers on Thursday (Feb. 1) asked CMS to make sure changes to Medicare Advantage are carried out in a transparent manner, coming the same day CMS released a draft 2019 MA and Part D Call Letter it says was driven partly by stakeholders' responses to a wide-ranging request for information.

February 01, 2018 | Daily News

President Donald Trump urged GOP lawmakers gathered in West Virginia Thursday (Feb. 1) to pass a federal Right to Try bill, and asserted that FDA Commissioner Scott Gottlieb is “heading it up,” despite the commissioner's previously expressed concerns with legislation passed by the Senate last year and pending in the House.

February 01, 2018 | Daily News

The advocates behind Patients for Affordable Drugs have launched a new organization, which will spend seven figures in the 2018 midterm elections to support candidates that back drug pricing reform.

February 01, 2018 | Daily News

Stakeholders are divided over whether there is a need for a national prescription drug monitoring program (PDMP), with some asserting the existing state systems simply need to be improved to enhance interoperability and data sharing and others calling for a national system that would provide real-time data and integrate into clinical workflows.

February 01, 2018 | Daily News

FDA Commissioner Scott Gottlieb told legislators Tuesday (Jan. 30) that FDA will take a risk-based approach to both the yet-to-be-finalized 503B-lite category of compounders and the new model agreement between states and FDA on oversight of compounders that ship products out of state.

January 31, 2018 | Daily News

Senate Finance Chair Orrin Hatch (R-UT) asked new HHS Secretary Alex Azar to consider moving the 340B drug discount program from the Health Resources and Services Administration, which has run the program since its inception, to CMS.

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