United States: Capitol Hill Healthcare Update - April 8, 2019

Below is this week's "Capitol Hill Healthcare Update," which is posted on Mondays when Congress is in session.


The House Ways and Means Committee is scheduled to vote Tuesday on legislation that contains several prescription drug pricing provisions, including requiring pharmacy benefit managers to disclose details of negotiated rebates and calling on drug manufacturers to justify price increases.

The legislation by committee Chairman Richard Neal, D-Mass., would force drug manufacturers to publicly justify significant price increases and disclose research and marketing costs. Building on Sunshine Act reporting requirements, the measure also would require drug and medical technology manufacturers to disclose the value of free samples they give to healthcare providers.

Meanwhile, the House Energy and Commerce Committee last week approved several drug pricing bills, including one that would allow generic manufacturers to gain access to drugs protected under the FDA's most stringent safety protocol. Other approved legislation would prohibit so-called pay-for-delay agreements between brand and generic drug companies.

The bills are not expected to be considered in the House this week before lawmakers adjourn for a two-week spring recess.


Bipartisan legislation to repeal the medical device tax is scheduled to be introduced as soon as this week, now that sponsors have secured the commitment of more than half of all House lawmakers.

The bill by Reps. Ron Kind, D-Wis., and Jackie Walorski, R-Ind., had been delayed as supporters worked to generate a majority of House support. The bill is scheduled be introduced this week before Congress goes on a two-week spring recess.

A bipartisan group of 20 senators last month introduced separate legislation to repeal the device tax. Introduced by Sens. Pat Toomey, R-Penn., and Amy Klobuchar, D-Minn., the bill has more backing from Senate Democrats than any previous attempt to roll back the tax.

The 2.3 percent excise tax on medical device sales was enacted as part of the Affordable Care Act. It first took effect in 2013 but has been suspended since 2016.

It's scheduled to come back online in 2020 unless Congress acts to further delay it.

While another delay in the tax enjoys strong bipartisan support in Congress, its path forward is unclear. Lawmakers could consider suspending the tax in a year-end legislative package. But medical technology manufacturers will have to start preparing for the tax this year; unlike taxes that are paid annually, the industry's first device tax payment to the IRS will be due in January 2020.


Testimony from executives of five major pharmacy benefit managers will highlight a Senate Finance Committee hearing Tuesday on prescription drug prices.

Senior executives from Cigna Corp., Humana Inc., OptumRx Inc. and other pharmacy benefit managers are scheduled to testify before the committee.

Meanwhile, comments are due today on draft HHS regulations that would eliminate the $29 billion in rebates that pharmaceutical manufacturers pay to pharmacy benefit managers, as the intermediaries between drug makers and insurers, in Medicare Part D and Medicaid managed care plans.


Senate HELP Committee Chairman Lamar Alexander, R-Tenn., said his committee will take action this summer on a series of bills designed to reduce healthcare costs.

Alexander, during a speech last week on the Senate floor, said he is working on legislation with the top Democrat on this committee, Sen. Patty Murray, D-Wash., and Finance Committee Chairman Chuck Grassley and ranking Democrat Sen. Ron Wyden, D-Ore. Alexander's committee and the Finance Committee share jurisdiction over certain healthcare policies.

"My top healthcare priority this Congress is to enact legislation that will give all Americans an opportunity for better health outcomes and better health experiences at a lower cost," Alexander said.

He said patients shouldn't be prohibited from knowing the cost of a surgery or a doctor's visit before scheduling the procedure or appointment, and insurers should be allowed to recommend to patients lower-cost options or higher-quality providers.

Alexander said he backs reforming prescription drug rebates, including extending the Trump administration's proposed regulation requiring negotiated drug rebates in Medicare Part D plans to be extended to private commercial plans. He also singled out surprise medical bills as an area for bipartisan cooperation.

The senator said he hoped to be able to approve several of these bills that are under his committee's jurisdiction this summer, combine them with separate legislation approved by Grassley's committee and have the package ready for consideration by the full Senate.

But Majority Leader Mitch McConnell, R-Ky., earlier this month said the Senate would be unlikely to move comprehensive healthcare legislation. The coming 2020 presidential election – in which multiple Senate Democrats are running – would complicate consideration of even a non-controversial healthcare measure.


House Republicans are warning pharmaceutical manufacturers that Democrats are bragging that their investigation into drug prices is depressing company stock prices.

In letters to 12 pharma CEOs, Rep. Jim Jordan, R-Ohio, cautioned pharma companies against turning over proprietary information to Oversight and Reform Committee Chairman Elijah Cummings, D-Md., saying he has previously "cherry-picked...internal corporate documents" to release publicly.

Cummings' committee in January launched a wide-ranging investigation into how the pharmaceutical industry sets prices, including asking companies for detailed information about pricing and marketing practices.

Jordan's letters were sent to AbbVie, Celgene, Eli Lilly, Malllinckrodt and other major pharmaceutical companies.

Jordan is the ranking Republican on the committee. The letters were also signed by Rep. Mark Meadows, R-N.C., the top Republican on the panel's Government Operations Subcommittee.


A House investigative panel on Wednesday will hold its second hearing in as many weeks on causes for recent price increases in insulin.

The Energy and Commerce Subcommittee on Oversight and Investigations will hear testimony from the three U.S. insulin manufacturers and three pharmacy benefit managers. The subcommittee last week heard from researchers on insulin supply chain issues and why more manufacturers weren't entering the space.

Subcommittee Chairwoman Diana DeGette, D-Colo., has questioned manufacturers over insulin prices. DeGette is also co-leader of the Congressional Diabetes Caucus.


The House voted mostly along party lines last week to approve a non-binding resolution condemning the Trump administration for asking a federal court to overturn the Affordable Care Act (ACA).

The Justice Department last month called on the Fifth Circuit Court of Appeals to strike down the ACA in its entirety, rather than striking down just part of the law. Democrats pounced on the move, saying repealing the 2010 health reform law would end popular provisions, such as requiring insurers to cover people with preexisting conditions.

Republicans have been tying themselves in political knots since the Justice Department called for overturning the ACA. President Donald Trump said his party's leaders in Congress would soon develop a new healthcare plan that could replace the ACA if the court struck it down.

But congressional Republicans – including Senate Majority Leader Mitch McConnell, R-Ky. – said the White House, not Congress, must develop the GOP's next steps on healthcare. The finger pointing on both ends of Pennsylvania Avenue only underscores Republicans' deep divisions on healthcare policy.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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