United States: Capitol Hill Healthcare Update - February 5, 2018


Congress is expected this week to approve a fifth stopgap budget bill to keep the government open in advance of a Thursday shutdown deadline, and key healthcare provisions could be included in the budget package.

If Congress only extends current funding into March, GOP leaders could include a renewal of the federal community health centers program to attract Democratic votes. That bill also could include a series of expired Medicare programs like the Medicare-Dependent Hospital program, the enhanced Low-Volume Adjustment program, the ambulance add-on payment program and payments for home infusion drugs.

Lawmakers are also negotiating a larger budget deal that would raise budget caps by nearly $300 billion over two years, covering both Pentagon and nondefense spending. If that larger agreement is reached, as much as $100 billion of the new spending could be offset, and Democrats are pushing for several pay-fors that could affect the pharmaceutical industry.

Among the targets are a requirement that producers of biosimilars offer discounts to Medicare beneficiaries inside the so-called Part D donut hole, just like the discounts required of branded biologic manufacturers. Another offset would impact Medicaid rebates for new formulations.

Democrats are also pushing for changes to FDA safety programs that could give generic drug manufacturers easier access to Risk Evaluation and Mitigation Strategies (REMS)-protected drugs. Most Republicans worry that that effort, as currently written, would create new opportunities for litigation by generics companies.

Although Republican leaders – along with PhRMA and BIO – are pushing back on the REMS provision, it does have support among some key GOP lawmakers, including Senate Judiciary Committee Chairman Chuck Grassley, R-Iowa, and Sens. Mike Lee, (R-Utah, and Rand Paul, R-Ky.)


Calling high prescription drug prices one of his administration's top priorities, President Trump used his State of the Union address last week to say "prices will come down substantially."

Rep. Elijah Cummings, D-Md., dismissed Trump's claim, saying it amounted to empty rhetoric after the White House failed last year to advance substantial policies on drug prices. Cummings – who wants Medicare to set prices and allow prescription drugs to be imported from other countries – said there's been "radio silence" from Trump on drug prices.

While the administration has shown no sign of embracing Cummings' proposals, it has taken steps to address drug prices, including speeding approvals of low-cost generics and streamlining reviews of applications when there's only one generic drug in the marketplace. FDA last year approved 763 generic drug applications, compared to 651 in 2016 and 492 in 2015.


In his State of the Union address last week, President Trump called on Congress to approve controversial legislation that would give terminally ill patients wider access to prescription drugs that haven't won FDA approval.

Trump repeated the plea later in the week at a closed-door meeting of House and Senate Republicans in West Virginia.

The so-called right-to-try legislation won Senate approval last summer, and it has the backing of Vice President Pence. But key House leaders had been cool to the idea, warning it could give patients false hope while undermining ongoing clinical trials.

House Energy and Commerce Committee Chairman Greg Walden, R-Ore., has said he was open to considering the issue but suggested there would likely be changes to the Senate-passed bill or the House version introduced by Rep. Andy Biggs, R-Ariz.

Biggs and 40 other House lawmakers sent a letter today to House Speaker Paul Ryan and Majority Leader Kevin McCarthy urging them to schedule a vote on the bill. Advocates of the bill are also scheduled to meet with GOP leaders today to discuss the legislation, Biggs' office said.

Some pharmaceutical manufacturers, like Merck, have come out against the Senate-passed bill, which was introduced by Sen. Ron Johnson, R-Wisc. Others, like Johnson & Johnson, have said they will only consider requests for experimental drugs that come through FDA's existing compassionate-use program.


House Energy and Commerce Committee Chairman Greg Walden, R-Ore., announced today that HHS Secretary Alex Azar will testify next week on the department's fiscal 2018 budget request.

The White House on Feb. 12 is expected to release its government-wide fiscal 2018 budget request.

Azar will testify before the panel's Health Subcommittee. He is also expected to testify before Senate committees on the budget, but those dates have not been announced.


Two congressional committees this week will hold hearings on opioids while two key senators are asking for stakeholder input on how to curb opioid abuse among Medicare and Medicaid beneficiaries.

The House Ways and Means Subcommittee on Health on Tuesday will hold a hearing on the role data, addiction prevention and access to treatment play in addressing the opioid crisis. The Senate HELP Committee on Thursday will hold a hearing focusing on the crisis's impact on children and families.

The House Energy and Commerce Committee is expected to hold an opioid hearing later this month.

Separately, the leaders of the Senate Finance Committee want to hear from healthcare groups on potential legislative changes to reduce opioid abuse within Medicare and Medicaid. Committee Chairman Orrin Hatch, R-Utah, and ranking member Sen. Ron Wyden, D-Ore., sent letters last week to provider and patient groups seeking feedback and suggested policy changes.

One-third of Medicare beneficiaries received an opioid prescription in 2016, at a cost of $4 billion to Medicare Part D, and Medicaid in 2015 spent more than $9 billion treating patients with an opioid disorder, Hatch and Wyden wrote.


A bipartisan group of nearly 100 House and Senate lawmakers is asking FDA about shortages of IV fluid bags and other medical products months after hurricanes disrupted drug and medical device manufacturing in Puerto Rico.

In a letter to FDA Commissioner Scott Gottlieb, the lawmakers asked when the products will become widely available, whether approval of new suppliers is permanent or temporary, and how Congress can help remedy the situation.

The letter was written by Sens. Marco Rubio, R-Fla., and Richard Blumenthal, D-Conn., and includes 29 senators and 63 House lawmakers.

The lawmakers say the FDA should take steps to address the shortages, and they want information on the agency's response to the shortage of IV saline, which has "created a nationwide public health scare during the height of a severe flu season."


House Oversight and Government Reform Chairman Trey Gowdy, R-S.C., sharply criticized HHS last week for not complying with document and information requests from his panel.

Gowdy wrote in a letter to new HHS Secretary Alex Azar that HHS has been "nonresponsive" and demonstrated "wanton disregard" for the committee's oversight responsibilities. Gowdy said that when HHS does respond to his panel's requests for information, the responses are often incomplete.

Gowdy cited requests for information regarding the federal response to hurricanes in Puerto Rico, opioid abuse within Medicare Part D and other issues.

Azar was sworn in last week, four months after former HHS Secretary Tom Price resigned.

While Gowdy's committee does have oversight authority over certain HHS functions, it does not have legislative oversight of the department. HHS and its various agencies do tend to be more responsive to inquiries from the Energy and Commerce and the Ways and Means committees than to Gowdy's panel. Still, an Azar spokesman said the department would meet with Gowdy's staff and respond to all outstanding requests.

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