Health Law Update

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<img class="alignright size-medium wp-image-4777" src="https://healthlawupdate.bakerhostetlerblogs.com/wp-content/uploads/sites/19/2017/03/hlu-photo-300x200.jpg" alt="" width="300" height="200">Senate Readies for Key Procedural Vote on Healthcare Bill – Maybe

Senate Republicans face a key procedural vote this week that would allow for debate of their healthcare legislation, but significant uncertainty remains about whether GOP senators can meet that procedural hurdle, what the underlying healthcare bill would be and how an impending White House announcement could impact the debate.

Senate Majority Leader Mitch McConnell (R-Ky.) pledged he would force a vote this week on a “motion to proceed,” which is procedural action that would permit debate on his underlying healthcare legislation. McConnell’s challenge is that he can only afford to lose two of his 52 GOP colleagues on that procedural vote; failure means the Senate can’t even bring up its healthcare bill for debate.

At least four Republican senators last week announced their opposition to the motion if the underlying legislation was the reworked bill to mostly repeal and replace the Affordable Care Act. In an effort to get past the procedural hurdle, McConnell said he would switch the underlying legislation to a straight ACA repeal, modeled on legislation that Republicans backed in 2015 but that was vetoed by President Obama.

McConnell has delayed key votes on healthcare twice in recent weeks, and it’s possible he will do so again this week. But Senate staff say McConnell wants the Senate on record one way or the other. Still, it’s unclear as of this morning whether McConnell will propose the 2015 repeal bill or his ACA repeal and replace legislation.

External conservative activists and political groups – as well as the White House – are putting enormous pressure on the GOP to support a straight ACA repeal, which would include a two-year phase down that presumably would buy Republicans more time to reach consensus on a replacement structure. Wavering Republicans say the 2015 vote was meant to be symbolic because they knew Obama would veto it; several GOP senators from states that expanded Medicaid say they would oppose voting to end that expansion now without a clear plan on what would follow.

Complicating McConnell’s math on the procedural vote and any votes that may follow was the announcement last week by Sen. John McCain (R-Az.) that he has brain cancer. It’s not clear when McCain will begin treatment or could be available to return to the Capitol – which potentially leaves McConnell with a one-vote margin of error among his deeply splintered caucus.

If Republicans were able to begin debating legislation and McConnell brought up the latest GOP version of ACA replacement legislation, he would face additional procedural headaches. The Senate parliamentarian ruled last week that several provisions do not qualify under budget reconciliation rules to be included in the fast-track legislation.

Many of these provisions – including blocking Planned Parenthood from federal healthcare reimbursement and preventing ACA insurance plans from covering abortion – were included to woo key GOP factions. But keeping them in the bill after the parliamentarian’s ruling would mean the bill requires 60 votes to pass, a threshold Republicans cannot achieve.

If Republicans overcome the procedural vote and advance to underlying legislation, the Senate would debate that bill for up to 20 hours, and any senator could offer amendments.

Meanwhile, President Trump will deliver a statement on healthcare at 3:15 p.m. today. It’s not known what the president will say, but over the weekend he chided Republicans on their failure to pass a healthcare bill. “If Republicans don't Repeal and Replace the disastrous ObamaCare, the repercussions will be far greater than any of them understand!” Trump tweeted on Saturday.

Senate Leaders Expected to Announce Schedule for User Fee Renewal

Senate Republican leaders this week are expected to outline a schedule for the chamber to consider FDA user fees for pharmaceutical and medical technology manufacturers.

Stalled action on repealing the Affordable Care Act delayed Senate consideration of the user fees. The current user fee agreement expires September 30, but there’s a separate August 1 deadline that would trigger layoff notices to FDA staff if Congress doesn’t agree to a renewal package by then.

While the underlying user fees and added policy provisions enjoy bipartisan support – the bill won House approval earlier this month on a voice vote – leaders fear it could get gummed up in the Senate, where lawmakers may derail the fragile compromise by offering controversial amendments. Those amendments include efforts to reduce prices for prescription drugs and allowing terminally ill patients access to drugs that are still in clinical testing.

If the Senate this week does not begin debating its ACA replacement plan, a vote on the House-approved user fee bill could be accelerated. If the Senate does advance to ACA-related legislation, consideration of the user fee bill before August 1 becomes more doubtful.

CHIP Renewal Likely Delayed Until September

With only days left before Congress is scheduled to begin a summer recess, lawmakers aren’t likely to reauthorize a popular, bipartisan children’s insurance program until after Labor Day.

House and Senate hearings on the Children’s Health Insurance Program (CHIP) have been delayed for months, and neither chamber has even drafted reauthorization legislation. The House is scheduled to begin its recess Friday; the Senate pushed back the start of its recess to mid-August.

CHIP, which expires September 30, provides health coverage to 9 million children whose families fall in a gap between Medicaid eligibility and ability to afford private insurance.

While CHIP itself is mostly non-controversial, its risk is its popularity: Lawmakers could seek to attach other healthcare or even unrelated provisions, jeopardizing reauthorization before the deadline. Some congressional staff have also speculated about a temporary CHIP extension to give lawmakers more time to pass a two-year renewal.

Schumer Says Dems Will Keep Up Pressure on Drug Prices

Senate Democrats today are expected to outline an economic policy agenda that includes targeting prescription drug prices.

Senate Minority Leader Chuck Schumer (D-N.Y.) on Sunday said the Democrats’ “Better Deal” plan will include “going after drug companies.” Specifically, Democrats will back allowing Medicare to negotiate drug prices within Part D plans and requiring drug manufacturers to publicly justify any “significant price increase.”

Separately, a leading Republican voice on healthcare policy – Sen. Bill Cassidy (R-La.), a former gastroenterologist – last week seemed to hint at supporting drug importation. Speaking at a healthcare event, Cassidy talked about the benefit of Walmart buying drugs in bulk in France that only have single-source manufacturers in the United States.

Meanwhile, House Republicans defeated an effort last week by Rep. Marcy Kaptur (D-Ohio) that would have called on the U.S. Department of Health and Human Services (HHS) to report federal and state spending on prescription drugs for brand-name drugs, biologics, generic drugs and biosimilars. Kaptur’s amendment was defeated 24-27 in the Appropriations Committee, but two Republicans voted for it – Reps. Jamie Herrera Beutler (R-Wa.) and Evan Jenkins (R-W.V.).

Healthcare Spending Bill Advances in House but Fate Uncertain

The House Appropriations Committee last week approved the largest domestic appropriations bill – including for HHS – but the legislation is likely to get tripped up by intra-Republican feuding ahead of the start of the federal fiscal year this fall.

The overall $156 billion spending bill for the departments of Labor, Health and Education includes more funding for NIH, CDC and HHS. The bill is $5 billion below last year’s levels, with most of the cuts coming from labor programs. The legislation is a lightning rod on abortion, as it would eliminate funding for Planned Parenthood and other family planning services.

Congress hasn’t approved a budget for fiscal 2018, which begins October 1, and it’s unlikely that the House and Senate will be able to separately approve the spending bill before the end of September. Instead, lawmakers are likely to consider a stopgap funding bill for the Labor, Health and Education departments that would extend last year’s spending levels into at least the first several months of fiscal 2018.

Senators Call on FDA to Crack Down on ‘Anti-Competitive’ Behavior

A group of Republican and Democratic senators last week called on FDA Commissioner Scott Gottlieb to thwart “anti-competitive practices” by brand-name pharmaceutical manufacturers that they say delays the introduction of generic drugs in the market.

Led by Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) and the committee’s top Democrat, Sen. Patrick Leahy (D-Vt.), the senators also promoted their introduced legislation that would grant generic and biosimilar manufacturers a new right to sue brand-name companies in federal court over access to drugs covered by the FDA-mandated safety program Risk Evaluation and Mitigation Strategies (REMS).

Critics say innovator companies use REMS to block access to drugs that generic companies need for bioequivalence testing. Brand-name manufacturers believe the legislation is flawed because it would provide incentives to litigate rather than negotiate the transfer of samples or entrance into single, shared REMS systems.

The senators – which also included Sens. Mike Lee (R-Utah) and Amy Klobuchar (D-Minn.) – called on Gottlieb to take a more expansive view than that of previous commissioners of FDA’s authority to waive the requirement for a single, shared REMS.

House Democrats Split on IPAB Repeal

During a House hearing last week on a controversial board designed to control Medicare spending growth, key Democrats disagreed on whether the Independent Payment Advisory Board (IPAB) should be abolished.

Rep. Frank Pallone (D-N.J.), the top Democrat on the Energy and Commerce Committee, said Congress shouldn’t cede legislative authority to an independent body like IPAB. But Rep. Anna Eshoo (D-Calif.), a leading voice in healthcare among committee Democrats, said IPAB is a valuable tool to control spending and Congress shouldn’t rush to eliminate it.

Providers are nearly universally opposed to IPAB, fearing it would promote reduced reimbursements.

Created by the Affordable Care Act, IPAB would enjoy unprecedented authority that Congress likely couldn’t stop. If future Medicare growth exceeded a certain threshold, IPAB would make recommendations to reduce Medicare spending. Lawmakers could block those recommendations only with super-majority votes.

Medicare’s actuaries last week announced future Medicare spending would likely remain below the threshold that would trigger IPAB for the next several years.

House Lawmakers Reintroduce Bill to Coordinate Kids’ Care

Bipartisan legislation reintroduced in the House last week aims to improve health outcomes by coordinating care under Medicaid for children with complex medical conditions.

Led by Reps. Joe Barton (R-Texas) and Kathy Castor (D-Fla.), the legislation would allow states to participate in national children’s hospital networks, effectively allowing kids living in one state to be treated by pediatric providers in other states. The bill wouldn’t mandate that states participate but would allow them to opt in to the networks, which could coordinate services among home, primary, ambulatory, acute and post-acute care providers.

More than 30 million children nationwide are covered by Medicaid, and the 2 million children who have complex medical conditions face uneven care, especially when crossing state lines to access specialized services.

A version of the legislation was introduced in Congress last year and gained significant bipartisan support in both the House and Senate. Similar legislation was introduced earlier this year by Senate Judiciary Committee Chairman Charles Grassley (R-Iowa) and Sen. Michael Bennet (D-Colo.).

Capitol Hill Healthcare Update