United States: Capitol Hill Healthcare Update - January 22, 2018

SENATE SCHEDULES NOON VOTE TO END GOVERNMENT SHUTDOWN

With the government shutdown entering its third day, the Senate scheduled a procedural vote at noon today that could pave the way to end the stalemate – but it's not clear there's enough support to break the logjam and reopen the government.

The House last week approved a four-week spending bill to keep the government open, renew the Children's Health Insurance Program and suspend a series of Affordable Care Act provider taxes. Senate Democrats filibustered that bill, triggering the shutdown. Democrats say they want the budget bill to also address immigration policy affecting so-called Dreamers, young people brought into the country illegally by their parents years and sometimes decades ago.

A bipartisan group of senators is working to find a legislative solution, including reopening the government and approving another stopgap spending bill to keep Washington funded through Feb. 8. But after being in session all weekend, it's not clear that senators will achieve consensus on either the immigration policy or the procedural vote at noon – potentially extending the government shutdown beyond today.

SHUTDOWN AFFECTS RANGE OF FEDERAL HEALTHCARE AGENCIES, PROGRAMS

Tens of thousands of federal workers at the Department of Health and Human Services (HHS) and its dozens of healthcare-related agencies are being furloughed today as the government shutdown enters its third day.

HHS announced that about half its workforce – or 40,959 employees – is being furloughed.

Food and Drug Administration (FDA) user-fee programs will be operational during the shutdown, as will critical public health activities like high-risk recalls, civil and criminal investigations, and import entry reviews. FDA will stop routine inspections as well as some compliance and enforcement activities.

At the Centers for Medicare & Medicaid Services (CMS), Medicare will continue largely without disruption, including processing of provider reimbursements. Other nondiscretionary activities – including at the Center for Medicare & Medicaid Innovation – won't be affected either.

The National Institutes of Health (NIH) is continuing patient care for current NIH Clinical Center patients but with minimal support and staffing for ongoing protocols. NIH won't admit new patients, initiate new protocols or take any actions on grant applications or awards.

The Centers for Disease Control and Prevention (CDC) is maintaining operations but with a "significantly reduced capacity to respond to outbreak investigations," according to HHS. CDC won't support most noncommunicable disease prevention programs or update disease treatment and prevention recommendations.

The Health Resources and Services Administration (HRSA) is continuing activities funded through sources other than annual appropriations, including the Community Health Centers. But HRSA won't make payments for the Children's Hospital GME Program during the shutdown.

SENATE COMMITTEE ADVANCES AZAR'S NOMINATION TO LEAD HHS

The Senate Finance Committee last week approved the nomination of Alex Azar to be HHS secretary.

Because of the ongoing government shutdown, it's not clear when the Senate will vote to confirm Azar. GOP leaders would like to have Azar in place before Jan. 30, when President Donald Trump is scheduled to give his first State of the Union address.

Sen. Tom Carper, D-Del., was the only Democrat to vote for Azar's confirmation in committee, which approved the nomination on a 15-12 vote. With a handful of other Democrats – including Sens. Joe Manchin, D-W.Va., and Heidi Heitkamp, D-N.D. – announcing their support for Azar's nomination, his eventual confirmation is all but guaranteed.

KEY COMMITTEE CHAIRMEN WEIGH IN ON PROPOSED PART D RULE

The leaders of Congress's principal healthcare committees last week urged CMS to "proceed with careful deliberation" on potential changes designed to reduce consumers' out-of-pocket costs in the Medicare Part D prescription drug program.

CMS in November sought stakeholder feedback on a proposed rule that would base patients' out-of-pocket expenses on what drugs cost after pharmaceutical manufacturer rebates, not on drugs' retail prices. In a letter to CMS, the House and Senate committee chairmen said they didn't want the agency to upend the original intent of the Part D "non-interference clause," which blocks the government from negotiating directly with manufacturers on drug prices.

While many congressional Democrats have long called for the government to directly negotiate drug prices for federal programs like Part D, Republicans say the non-interference provision allows for robust private competition that has held down consumers' Part D premiums for more than a decade. In his Senate confirmation hearings earlier this month, HHS Secretary-Designee Alex Azar reiterated that GOP-held position.

The letter was signed by Senate Finance Committee Chairman Orrin Hatch, R-Utah, House Ways and Means Committee Chairman Kevin Brady, R-Texas, and House Energy and Commerce Committee Chairman Greg Walden, R-Ore.

PENCE PRESSES FOR HOUSE ACTION ON 'RIGHT-TO-TRY' LEGISLATION

Vice President Pence weighed in on Twitter last week, urging the House to take up Senate-passed legislation that would give terminally ill patients wider access to prescription drugs that haven't yet won FDA approval.

"It's about restoring hope and giving patients with life-threatening diseases a fighting chance. Let's get this DONE," Pence tweeted.

Backers of the Senate bill – authored by Sen. Ron Johnson, R-Wis. – also have the support of Americans for Prosperity, which is funded by Republican activist brothers David Koch and Charles Koch. The group has called on House Energy and Commerce Committee Chairman Greg Walden, R-Ore., to schedule a vote on the bill.

Walden told reporters last week that he was open to considering the issue but said there would likely be changes to Johnson's bill or the House version introduced by Rep. Andy Biggs, R-Ariz. Walden said he wanted to balance patient safety with not giving the terminally ill false hope that they could benefit from treatments still undergoing clinical testing.

SENATOR INTRODUCES 340B LEGISLATION THAT HOSPITALS OPPOSE

Sen. Bill Cassidy, R-La., a former gastroenterologist and leading Republican voice on healthcare policy, introduced legislation last week that would create a two-year moratorium on new hospitals participating in the 340B prescription drug discount program.

Cassidy's bill also would require entities already in the program to submit detailed reports on their charity care costs, use of 340B drugs and drug reimbursements. The legislation mirrors a bipartisan House bill introduced last year by Reps. Larry Bucshon, R-Ind., and Scott Peters, D-Calif.

The House Energy and Commerce Committee earlier this month released an 80-page report on the 340B program that focused on its recent growth and outlined recommendations for changes.

Committee Chairman Greg Walden, R-Ore., said that beginning next month, he will introduce legislation implementing some of his panel's recommendations, including boosting the oversight authority of HRSA, which is responsible for the 340B program; requiring covered entities to use program savings in specific ways to improve patient care; and boosting covered entities' reporting requirements.

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