United States: Capitol Hill Healthcare Update - February 2019

Below is this week's "Capitol Hill Healthcare Update," which is posted on Mondays when Congress is in session. Highlights this week: shutdown risk increases as talks stall; Gottlieb's Hill testimony postponed; more bills targeting drug prices introduced; hearing focuses on bolstering ACA; and more.


Bipartisan negotiations to avert a new partial government shutdown – which would include the FDA – broke down over the weekend amid continuing disagreements over funding for border security, immigrant detention policies and interior enforcement.

Congress and the White House face a Friday deadline to reach a budget agreement before funding expires for multiple government departments and agencies. Leaders in both parties said last week they were adamant in wanting to avoid another shutdown.

If negotiations remain bogged down, one alternative is for Congress to approve a stopgap funding bill to keep the government open while discussions continue. Other options are less appealing: a partial government shutdown or President Donald Trump declaring a national emergency, under which the White House would redirect existing funding to build a wall along the U.S.-Mexico border. Such a declaration – opposed by Democrats and many Republicans on Capitol Hill – would likely be challenged in court.

During the 35-day closure in December and January – the longest shutdown in history – all but essential functions were shuttered at the departments of Agriculture, Commerce, Justice, Homeland Security, Interior, State, Transportation, and Housing and Urban Development, as well as several smaller agencies. Nearly 800,000 workers were furloughed, including nearly 7,000 at the FDA.

If there's another shutdown, the FDA would be prevented from accepting new drug and medical device applications. The agency could continue working on applications where user fees were paid before a shutdown begins.


President Donald Trump last week urged Congress to approve $500 million to study childhood cancer, but the top Democrat on Capitol Hill criticized the proposal as inadequate.

During his State of the Union address, Trump recognized Grace Eline, a 10-year-old girl diagnosed with brain cancer. He said many childhood cancers have not seen new therapies in decades, and he called on Congress to approve $500 million over 10 years to fund childhood cancer research.

"$500 million over 10 years – are you kidding me?" Pelosi reportedly later told Democrats in a closed-door meeting. "We're talking about a moonshot. He's talking about a trolley ride."

Of the National Cancer Institute's $6.1 billion annual budget, only about 5 percent is targeted to childhood cancer research, according to the Coalition Against Childhood Cancer.


Nearly 40 House lawmakers called on CMS to withdraw a proposed regulation that aims to lower prescription drug costs by allowing Medicare Part D and Medicare Advantage plans to exclude from formularies coverage of certain medicines – including cancer drugs.

CMS says its proposal would give plans flexibility not to cover drugs in the so-called six protected classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals and cancer drugs.

The move sparked concern among patient groups, which fear newly approved treatments could lack Medicare coverage.

Rep. Grace Napolitano, D-Calif., organized a letter to HHS Secretary Alex Azar, writing that upending the protected classes would jeopardize the health of patients living with mental illnesses, AIDS, cancer, epilepsy and organ transplants. Napolitano, who is founder of the Congressional Mental Health Caucus, said the policy change could cause patients to drop their current medication in favor of new drugs subject to prior authorization or step therapy.


Senate Finance Committee Chairman Chuck Grassley, R-Iowa, reintroduced bipartisan legislation last week that aims to coordinate care under Medicaid for children with complex medical conditions.

The ACE Kids Act 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.

Sen. Michael Bennet, D-Colo., is co-sponsoring the legislation, and companion legislation is expected to be introduced in the House.

Medicaid covers about two million children with complex medical conditions, including cancer, congenital heart disease, cystic fibrosis, Down syndrome and chronic health challenges from premature birth. On average, children with complex medical needs require five to six specialists, with as many as 30 health and allied health professionals involved in their care.

Grassley said many children require travel to another state to find appropriate treatment, and the legislation would streamline that process under Medicaid.

The measure nearly passed Congress last year but was tripped up by the lame-duck session and the partial government shutdown that began in December.


FDA Commissioner Scott Gottlieb was scheduled to testify Tuesday before the House panel that approves his agency's congressional appropriations, but the hearing has been postponed to allow lawmakers to attend the funeral of Rep. John Dingell, D-Mich.

Dingell, 92, served in the House for 59 years – the longest tenure in history – and was chairman of the Energy and Commerce Committee, which has jurisdiction over the FDA and several Medicare Part D plans.

Gottlieb was the only witness to testify before the House Appropriations Agriculture Subcommittee, just three days before funding is scheduled to expire. The commissioner was expected to outline how the most recent shutdown affected operations with drug and medical device approvals.


The House Ways and Means Committee on Tuesday will hold its first hearing on prescription drug prices, as lawmakers in both chambers continue to introduce legislation targeting drug prices.

Witnesses include Mark Miller of Arnold Ventures; Rachel Sachs of Washington University; Alan Ruether of the United Autoworkers; Dr. Odunola Ojewumi, a patient from Maryland; and Joseph Antos of the American Enterprise Institute.

Rep. Lloyd Doggett, D-Texas, last week reintroduced legislation that would allow Medicare to negotiate prices directly with manufacturers – and if the companies refuse to negotiate, HHS could invalidate patents and grant competitive licenses to other manufacturers.

Doggett's bill has more than 100 Democratic co-sponsors, including Reps. Peter Welch, D-Vt., and Elijah Cummings, D-Md., the chairman of the House Oversight and Reform Committee.

Doggett, the chairman of the panel's Health Subcommittee, introduced similar legislation last summer.

Sen. Sherrod Brown, D-Ohio, last week introduced a Senate version of Doggett's bill, with Sens. Amy Klobuchar, D-Minn., and Tammy Baldwin, D-Wis., as co-sponsors.

Separately, top executives from AbbVie, Johnson & Johnson, Sanofi and other pharmaceutical companies agreed to participate in a Senate Finance Committee meeting on Feb. 26. The hearing on drug prices is expected to be explosive, as it's the first time this many pharmaceutical CEOs have testified before Congress since the Affordable Care Act was debated in 2009 and 2010.


The Senate HELP Committee will hold a hearing Tuesday focusing on treating pain amid the opioids crisis.

The committee is expected to discuss pain management techniques and the development of new medicines and nondrug alternatives.


The House Energy and Commerce Health Subcommittee will hold a hearing Wednesday on a series of bills designed to bolster the Affordable Care Act (ACA) and the nation's insurance markets.

The panel will consider legislation by Rep. Ann Kuster, D-N.H., that would nullify Trump administration approval of states linking work requirements to expanded Medicaid coverage. The committee will review legislation by Rep. Lisa Blunt Rochester, D-Del., that would restore ACA outreach and enrollment funding to assist consumers in signing up for healthcare coverage.

Also scheduled for consideration is legislation by Rep. Kathy Castor, D-Fla., that would block the Trump administration's approval of short-term, limited-duration insurance plans.


The top Republican on the House Judiciary Committee introduced two bipartisan bills last week that would overhaul the role of pharmacy benefit managers, with the aim of increasing transparency and lowering prescription drug costs.

Introduced by Rep. Doug Collins, R-Ga., one bill would require that patients at the pharmacy counter benefit from price concessions generated by PBMs.

A second Collins bill aims to increase transparency about PBM operations in Medicare Part D, Medicare Advantage and Federal Employees Health Benefits Program plans.

Collins introduced both bills in the 115th Congress.

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.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions