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 Presses Ahead on Healthcare Talks as Deadline Looms

With only 10 legislative days before Senate Republicans’ self-imposed deadline, GOP lawmakers face growing obstacles in their quest to vote on replacing the Affordable Care Act (ACA) before the beginning of their scheduled Fourth of July recess.

Still, Majority Leader Mitch McConnell (R-Ky.) wants a vote by June 30, in part to clear the chamber’s calendar for other pressing issues this summer, including a fiscal 2018 budget blueprint, legislation to fund the government, and reauthorizing FDA user fees and the children’s health insurance program (CHIP).

Some conservative senators are voicing concern that Sen. McConnell may not be doing enough to curb Medicaid spending in the 31 expansion states. They point to the possibility that the ACA’s Medicaid expansion might last beyond the 2020 cutoff in the House bill as a sign moderate lawmakers are gaining the upper hand as McConnell tries to cobble together 50 votes for an overall package.

But moderate senators worry, too, that conservatives may pick up support for lowering the amount that Washington contributes to state Medicaid programs.

Not content to sit on the sidelines, Democrats are increasingly criticizing Republicans for crafting their bill behind closed doors with no public hearings or input from committees with jurisdiction over healthcare policy (even some rank-and-file GOP senators are voicing the same concern). Democrats this week may try to gum up the Senate with procedural objections in an effort draw attention to their concerns.

Minority Leader Chuck Schumer (D-N.Y,) also called on McConnell to allow all 100 senators to meet this week to hash out next steps on overhauling the health law. Republicans are unlikely to oblige.

While McConnell wants a vote this month, nothing prevents him from scheduling the vote when Republicans reconvene after the holiday beginning July 10. That would just start another clock with another deadline: The Senate is scheduled to be in session for only 15 legislative days in July before a beginning a month-long recess in August.

House, Senate Work to Finalize User Fee Bill

Although key House and Senate committees have approved a five-year renewal of FDA user fees for pharmaceutical and medical device manufacturers, the legislative process has stalled as lawmakers continue to grapple with what to do with the ACA. With the current user fee agreement set to expire in September and Congress’ summer calendar dominated by a series of must-do items, House and Senate committees are negotiating behind the scenes on what they hope will be a final bill that each chamber can approve. The goal would be for the House to approve its user fee bill with the Senate taking up that version, bypassing a conference committee.

The bills that won approval in the Senate HELP and House Energy and Commerce committees do have some differences. Still, leaders have worked to keep both bills free from controversial language, and committee staff says the differences shouldn’t stand in the way of reaching an agreement. Lawmakers had hoped to pass legislation in June, but Senate leaders in particular are wary of bringing the user fee bill to the floor before they figure out next steps on replacing the ACA. It’s more likely that the House and Senate will act in July.

Gottlieb to Testify on FDA Budget

FDA Commissioner Scott Gottlieb will testify <a href="https://www.appropriations.senate.gov/hearings/review-of-the-fy2018-food-and-drug-administration-budget-request">Tuesday</a> before the Senate Appropriations subcommittee that approves his agency’s annual budget. The panel will review President Trump’s proposed fiscal 2018 funding request and budget justification for the FDA. Released last month, Trump’s proposed budget would provide the FDA with $5.1 billion in total funding, an increase of $871 million over last year. But the White House wants to nearly zero out congressional appropriations and increase dramatically user fees paid by pharmaceutical and medical technology manufacturers. The current user fee agreement expires in September. Even if it wanted to – and there’s no indication Congress takes Trump’s FDA budget seriously – lawmakers have little time to re-order the pending user fee agreement before they hope to approve it in July.

Bill Would Extend 340B Drug Discounts to Rural Hospitals

New bipartisan <a href="https://www.congress.gov/bill/115th-congress/house-bill/2889?r=2">legislation</a> introduced in the House last week would overturn a 2015 federal court ruling that barred more than 1,000 rural hospitals nationwide from receiving price reductions on prescription drugs with orphan designations. Introduced by Reps. Peter Welch (D-Vt.) and Greg Harper (R-Mich.), the bill would allow the rural hospitals to receive federal 340B drug discounts for outpatient medicines that treat rare diseases.

PhRMA and critics of the 340B program say the legislation is flawed because it would not require that hospitals pass along those discounts to patients. Some Republicans – including Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa) – have criticized hospitals for gaming the program by pocketing the discounts to cover operating expenses.

The House Energy and Commerce Committee – on which both Welch and Harper serve as members – last month initiated an investigation of the 340B program, questioning whether the federal agency responsible for the program is effectively overseeing it.

Hearing on Drug Prices Dissolves Into Fight over ACA

The Senate HELP Committee last week held a <a href="https://www.help.senate.gov/hearings/the-cost-of-prescription-drugs-how-the-drug-delivery-system-affects-what-patients-pay">hearing</a> on prescription drug prices, but Democrats used the opportunity instead to criticize Republicans for trying to repeal the ACA. Committee Chairman Lamar Alexander (R-Tenn.) announced the hearing as the first in a series, mostly in an effort to prevent Democrats from slowing down separate FDA user fee legislation. But when Democrats spent most of the hearing criticizing the GOP’s efforts to replace the healthcare law, Alexander questioned the value of the hearing and openly speculated on whether additional hearings would be meaningful.

Bill Would Penalize Drug Companies for ‘Price Gouging’

Five Democratic senators <a href="https://www.brown.senate.gov/newsroom/press/release/brown-gillibrand-franken-reed-hassan-udall-introduce-legislation-to-protect-americans-from-prescription-drug-price-spikes">introduced</a> legislation last week that would penalize pharmaceutical manufacturers that “engage in unjustified price increases.” The legislation called the “Stop Price Gouging Act,” would require drug companies to publicly report and justify price increases. It also would hit companies with “financial penalties proportionate to the price spike,” with penalties earmarked to supplement NIH’s budget. The bill was introduced by Sens. Sherrod Brown (D-Ohio), Kirsten Gillibrand (D-N.Y.), Al Franken (D-Minn.), Jack Reed (D-R.I.), Maggie Hassan (D-N.H.) and Tom Udall (D-N.M.).

NIH Leaders to Testify Before Senate Panel

Although President Trump has proposed multibillion cuts to NIH’s budget, the federal research agency is expected to face a friendly audience when its leaders testify <a href="https://www.appropriations.senate.gov/hearings/hearing-to-review-the-fy2018-budget-request-for-the-national-institutes-of-health">Thursday</a> before the Senate appropriations subcommittee that approves its budget. Trump’s proposed 20 percent cut to NIH has fallen flat on Capitol Hill, although a handful of lawmakers have expressed a willingness to examine the agency’s functions because they say NIH spends too much on administration and overhead. Sen. Roy Blunt (R-Mo.), chairman of the Appropriations Labor-HHS subcommittee, has repeatedly criticized the White House’s proposed spending cuts and pledged to continue to boost spending for the agency.

CHIP Hearing Rescheduled for This Week

The House Energy and Commerce Health Subcommittee on Friday will <a href="https://energycommerce.house.gov/hearings-and-votes/hearings/examining-extension-safety-net-health-programs">examine</a> several safety-net health programs, including CHIP and community health center funding. Originally scheduled for last week, the hearing was postponed following the shooting of House Majority Whip Steve Scalise (R-La.) and others during a practice for the annual charity Congressional Baseball Game. The subcommittee’s chairman, Rep. Michael Burgess (R-Texas), said Congress is committed to renewing CHIP but left open the question of for how long – he offered two years as a possibility – and at what federal matching rate. In addition to CHIP, the subcommittee will also examine Federally Qualified Health Centers and the Community Health Center Fund, which supports grants to outpatient healthcare facilities and is the nation’s largest source of comprehensive primary care for medically underserved populations.

House to Vote This Week on Medical Malpractice Bill

Lawmakers this week are scheduled to vote on <a href="https://www.congress.gov/bill/115th-congress/house-bill/1215">legislation</a> that would establish limits on medical malpractice suits. Introduced by Rep. Steve King (R-Iowa), the bill would cap the amount patients could receive from lawsuits alleging harm or wrongdoing due to medical procedures. Long sought by congressional Republicans who say lawsuits lead to defensive medicine and increased healthcare costs, the bill is likely to win House approval. Its prospects are less clear in the Senate, where 60 votes would be needed to pass the bill.

Capitol Hill Healthcare Update