Burgess Floats ‘Warranty’ Value-Based Pay Path For Costly Cell & Gene Therapies

House Budget Committee Health Care Task Force Chair Michael Burgess (R-TX) is advocating a new value-based “warranty” payment approach for costly cell and gene therapies under which the therapy’s high upfront cost would essentially be mortgaged across payers as patients switch plans in subsequent years. The therapy’s initial high cost and the resulting long-term benefits would be shared across plans, but the drug maker would be on the hook to refund the cost if the therapy doesn’t work. Burgess highlights...
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ICER Requests Public Input To Identify Drugs For Price Hike Report

The Institute for Clinical and Economic Review (ICER) has released the official procedures for conducting its sixth assessment of major drugs that experienced substantial price increases without adequate evidence to justify the increases. The drug pricing watchdog will identify 10 drugs with net price hikes that have generated the largest increase in drug spending at the federal level and is seeking public input for an additional three drugs that have experienced similar price increases over the same timeframe but won’t...
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ICER Requests Public Input To Identify Drugs For Price Hike Report

The Institute for Clinical and Economic Review (ICER) has released the official procedures for conducting its sixth assessment of major drugs that experienced substantial price increases without adequate evidence to justify the increases. The drug pricing watchdog will identify 10 drugs with net price hikes that have generated the largest increase in drug spending at the federal level and is seeking public input for an additional three drugs that have experienced similar price increases over the same timeframe but won’t...
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Compound Pharmacy Group Cheers Lilly Loss In Compound GLP-1 Lawsuit

The trade organization for compounding pharmacies is praising a Florida federal judge’s decision to toss out Eli Lilly’s lawsuit against an online pharmacy that offers compounded versions of its popular diabetes and weight loss drug tirzepatide (Mounjaro), saying Lilly, and fellow GLP-1 manufacturer Novo Nordisk, are using frivolous litigation to discourage compounding. The court said FDA has jurisdiction over compounding, coming as the agency allows compounding of drugs in shortage, which include weight-loss drugs, but has also warned consumers that...
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CDER Announces New Center For Clinical Trial Innovation

FDA’s Center for Drug Evaluation and Research (CDER) is launching a new center that will focus on promoting innovative clinical trial approaches through internal and external collaboration, to be known as the Center for Clinical Trial Innovation (C3TI). The center will kick off with projects on point-of-care or pragmatic trials, Bayesian analyses, and trials using selective safety data collection. The center was announced in a Federal Register notice Monday (April 15). “CDER’s long-standing efforts to embed innovation in clinical...
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White House Says Launch Of New Global Health Strategy Depends On Funding

The White House is launching a new Global Health Security Strategy that will promote international collaboration on biosecurity issues, but funding for the initiative will be dependent on the fiscal 2025 budget passed by Congress. The strategy includes roles for FDA, the Centers for Disease Control and Prevention (CDC), the Administration for Strategic Preparedness and Response (ASPR), and other HHS agencies. A senior administration official told reporters in a conference call Monday night (April 15) funding for implementation of the...
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Ed & Workforce Dems Urge DOL To Consider ERISA Advisory Recs On Disability Benes

Democratic leaders of the House Education & the Workforce Committee are urging the Department of Labor to take a close look at the ERISA Advisory Council’s recommendations on ending disability benefits’ discriminatory treatment of conditions related to mental health/substance abuse and let lawmakers know whether additional authorities or resources are needed to implement the proposals. Most long-term disability plans, which are accessible to about 35% of private workers, currently treat disabilities arising from behavioral health conditions differently than those that...
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Advocates Remind Congress Of Child Tax Credit’s Health Benefits

Children’s advocates are urging the Senate to pass an expansion of the Child Tax Credit this year -- though the April 15 tax filing deadline has passed -- saying the House-passed proposal would benefit 5.8 million children younger than six within the first 12 months of enactment and free up family's finances so they don’t have to make as many sacrifices. The maximum refundable credit would increase starting this year under the Tax Relief for American Families and Workers Act,...
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Inside CMS - 04/18/2024
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Vol. 27, No. 16

Congress Probes Change Attack, Improper Pay; ERISA Turns 50

Congress is in and lawmakers are set to hear from a couple key health officials on their budget requests: HHS Secretary Xavier Becerra will testify twice on HHS’ budget -- first before the Senate Appropriations Committee Tuesday and then before the House Energy & Commerce Committee the following day. On Thursday FDA Commissioner Robert Califf will also make his case for increased funding and authorities before the House Appropriations Committee. Also this week, the House Energy & Commerce oversight subcommittee...
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Brooks-LaSure: CMS Isn’t Done With Prior Auth, MA Reforms

CMS is open to looking into insurers’ prior authorization practices for prescription drugs, Administrator Chiquita Brooks-LaSure told hospitals during a conference Monday (April 15), adding the administration is also diving into the issue of prior authorization as it relates to Medicare Advantage plans. “I think that we have taken some really important steps in our rules that we have done -- the rules that are broad across the industry and also specific to Medicare Advantage -- but we want to...
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