Drug Pricing
The Drug Pricing Debate Part II: The Many Acts of Congress
As we outlined earlier this spring, congressional action on drug pricing continues to intensify. Key committees have advanced an array of reforms, demonstrating Congress’ intent to finalize legislation this year. We aim to clarify what that might include....
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The Drug Pricing Debate: Sizing Up Recent Actions and What May Come Next
What goes up must — or rather, should — come down.
Such is the thinking of the Trump administration when it comes to prescription drug pricing, at least. Over the past five years, 12 of the 20 most commonly prescribed brand-name drugs have seen price increases of more than 50 percent.
To date, most of what we’ve seen from the federal government is messaging and some initial proposals, with the majority coming from the administration. Congress, for its part, has initiated a series of drug pricing hearings and begun introducing meaningful legislation. The result is a wide array of policy alternatives, some of which stand a chance of being enacted....
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What to Expect in Health Policy Under a Divided Congress
The 2018 midterm elections were powered by a “blue wave” that flipped control of the House of Representatives from the GOP to the Democrats but left the Senate in Republican hands, meaning the two chambers of Congress will be divided at least until 2020. In the Senate, Republicans have a 53 to 47 majority and will continue to be led by Senator Mitch McConnell of Kentucky, while House Democrats gained a 235 to 199 majority....
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What the 2018 Midterm Elections Means for Health Care
The fundamental shift in the balance of power in Washington will have substantial implications for health care policymaking over the next two years. In this post, I’ll take a look at which health care issues will come to the fore of the Federal agenda due to the outcome Tuesday, as well as state expansion decisions. And it should of course be noted that, in addition to positive changes Democrats are likely to pursue over the next two years, House control will allow them to block legislation they oppose, notably further GOP efforts to repeal the Affordable Care Act (ACA)....
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Implementation Of The Biosimilars Provisions Of The ACA — Where Are We Now?
Despite the passage of a 2010 law addressing such medicines, the Food and Drug Administration’s (FDA) approval this year of the first biosimilar has prompted a flurry of regulatory activity aimed at filling gaps left by the statute. For a helpful primer on the issue, see a recent Health Affairs Health Policy Brief. This post will address key concerns raised by recent FDA guidance, as well as other widely anticipated but yet-to-be released regulatory activity, such as the pivotal interchangeability standard....
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Review Of Proposed 340B Omnibus Guidance: How We Got Here And What It Says
In a previous post—now almost one and a half years ago—I described “the coming storm” I anticipated would develop around the 340B drug discount program. After a brief tornado hit the House Energy and Commerce Committee when they considered including 340B reforms in their 21st Century Cures initiative, a slower, hurricane-style churn over the Administration’s proposed guidance on the topic has settled in....
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The Coming Storm Over The 340B Rx Drug Discount Program
Beneath the glare of the wind-down of the ACA open enrollment period and wind-up of the 2015 Medicare regulation cycle, another Administration document is sitting at a few top officials’ desks for final review. It’s targeted for release in June but could come any day....
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