Financial Services Report

Our Take
The First Session of the 114
th came to a close last week, fittingly with the passage of the FY16 spending bill and a tax measure dealing with a series of expiring provisions, to tie a bow on a year whose schedule had been dictated by statutorily imposed deadlines.  Despite some Sturm und Drang that the collective size of the two bills would unite liberal Democrats and Conservative Republicans both measures ultimately passed by wide margins.   Credit for the smooth sailing should go to Senate Majority Leader McConnell who appears to have delivered on his promise to get the Senate working again, as well as to former House Speaker John Boehner for setting up a budget deal that gave appropriators $25 billion in sequester relief that allowed appropriators to plus up just the right accounts to help get the deal done. 

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Health Policy Report

The Week in Review 

The first session of the 114th Congress ended on a high note as Democratic and Republican lawmakers were able to work through their differences and pass a mammoth $1.6 trillion spending and tax deal that will fund the government for the remainder of the 2016 fiscal year. On Friday morning, House lawmakers voted on the omnibus and ‘tax extenders’ packages separately, passing the first by a vote of 316 to 113 and the latter by a 318 to 109 margin. The deal was then combined into a single bill (H.R. 2029) and presented to the Senate, who passed it on a 65-33 vote. President Obama has already indicated that he will sign the combined spending and tax package, which should mark the end of the final fiscal fight of his presidency. 

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Today on the Hill: First Session of the 114th Congress Set to Close with Omnibus Passage

Legislative action for the year is set to finish today as both chambers complete work on a $1.1 trillion omnibus spending bill (omnibus text; section-by-section summary), and an accompanying tax measure (tax package; section-by-section summary). The House has already passed the ‘tax extenders’ package and is poised to pass the omnibus this morning before combining the two measures and sending it to the Senate as a single bill (H.R. 2029). Senate lawmakers forged an agreement yesterday that will allow the upper chamber to forgo some time-consuming procedural steps and clear the legislation today. The unanimous-consent agreement stipulates that a cloture vote, as well as possible votes on a motion to table the spending amendment and on waiving a budget point of order, will go forward before a final vote on passage of the underlying bill. Senate Majority Leader Mitch McConnell (R-KY) has laid out the series of four roll call votes this morning to see the measure through the upper chamber. 

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Today on the Hill: Congress Reaches Agreement on Omnibus/Tax Extenders Package

Congressional leaders last night unveiled a broad package of spending and tax legislation that would avert a U.S. government shutdown, delay Obamacare’s medical device tax and Cadillac tax for two years, and lift the 40-year-old ban on crude oil exports, among other policy provisions. In a pair of measures around midnight last night, Congress released the texts of the $1.1 trillion omnibus measure (omnibus text; section-by-section summary) as well as a separate package to revive and, in some cases, make permanent a series of tax breaks (tax package; section-by-section summary). The $1.1 trillion spending measure would fund the government through September 30, 2016, and may well be the last substantive federal spending legislation before next November’s elections. Government funding expires at the end of the day today, and Congress is expected to pass a stopgap spending bill that funds the government until December 22 to give Congress time to consider the full-year measure. 

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Implementation Of The Biosimilars Provisions Of The ACA — Where Are We Now?

This post, penned by Thorn Run's Billy Wynne, originally appeared in Health Affairs Blog.

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 recentHealth 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.

Continue reading “Implementation Of The Biosimilars Provisions Of The ACA — Where Are We Now?”

Implementation Of The Biosimilars Provisions Of The ACA — Where Are We Now?

This post, penned by Thorn Run's Billy Wynne, originally appeared in Health Affairs Blog.

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 recentHealth 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.

Continue reading “Implementation Of The Biosimilars Provisions Of The ACA — Where Are We Now?”

Financial Services Report

Looking Ahead

Near Term

  • Congress has till Wednesday to resolve differences over the remaining issues — ranging from Syrian refugees to oil exports — that continue to be the impediment to passing a bill to fund the government for the remainder of FY16.
  • Debate and discussions also continue around the tax “extenders” package, including whether to make permanent several dozen expiring tax breaks, as well as to include delays on the implementation of the Affordable Care Act’s (ACA) “Cadillac” and medical device taxes.
  • The House Financial Services Committee will hold a hearing on the CFPB and how it is collecting and using data.
  • On Thursday, the FSOC will meet in a closed session via telephone to discuss the annual re-evaluation of the designation of a nonbank financial company.

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This Week on the Hill: Omnibus Negotiations Stand in the Way of Winter Recess

This week will test the ability for Democrats and Republicans to work through their differences towards compromise as lawmakers rush to complete a $1.1 trillion spending measure to fund the government and a package of tax breaks before the winter recess. Senate Majority Whip John Cornyn (R-TX) said the text of a broader omnibus spending bill may be filed this morning and that the goal is for both chambers to finish work on the measure by Wednesday evening, beating the deadline set by a short-term extension (H.R. 2250) passed last week. Members are trying to reconcile differences on the policy riders to be attached to the spending measure, including lifting the nation’s crude oil export ban, blocking Syrian refugee resettlement in the U.S., and repealing the Environmental Protection Agency’s Waters of the U.S. rule. 

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Health Policy Report

The Week in Review

The government was set to shut down last Friday, but the passage of a very short-term continuing resolution bought Congress five more days to resolve differences over issues ranging from taxes to Syrian refugees that stand in the way of funding the government through next September. The measure (H.R. 2250), which will keep the government funded through December 16, was the result of House and Senate appropriators failing to come to agreement on the policy riders that will accompany the must-pass omnibus bill. While the list of potential riders has been whittled down considerably, Congress will have only a few days to make the final tweaks before recessing for the winter holidays.

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This Week on the Hill: Omnibus Deadline Friday; Terrorism Concerns Mount

With highway funding and reconciliation settled, Congress is geared to begin a busy legislative week. Lawmakers will only have five days to complete an omnibus package funding the government beyond current funding’s expiration on December 11. The text of a $1.1 trillion omnibus bill may be posted today, which would allow the House to take up a bill on Wednesday. Appropriators have been negotiating the policy riders for such a measure, with House Democrats having already rejected Republicans’ first offer due to its inclusion of “poison pill” riders. However, progress has been made on one Republican rider as Senate Democrats have reportedly set out their terms for allowing the 40-year-old ban on crude oil exports to be lifted. Congressional staffers are scrambling to meet the Friday deadline for a funding measure, but Speaker Paul Ryan (R-WI) has already braced fellow Republicans to be flexible about working into the weekend to avoid a government shutdown. 

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