United States: Capitol Hill Healthcare Update - May 18, 2017

Senate Panel OKs FDA User Fees

Legislation reauthorizing FDA user fees for prescription and generic drugs, biosimilars, and medical devices won wide bipartisan approval last week in a Senate committee, teeing up approval by the full Senate, likely after the Memorial Day recess. The Senate HELP Committee approved the five-year renewal on a 21-2 vote. Sens. Bernie Sanders (I-Vt.) and Rand Paul (R-Ky.) voted against it. Taking the agreement negotiated by the FDA and industry stakeholders, the committee added multiple provisions – including pediatric drugs, regulation of hearing aids sold without prescriptions, and device inspections and regulation – that enjoyed bipartisan support within the committee.

Sen. Orrin Hatch (R-Utah) won approval for an amendment requiring the FDA and National Institutes of Health (NIH) to review both the accessibility and barriers to clinical trials for patients who don't respond to approved medications. The language was an effort to bridge differences between advocates of so-called right-to-try legislation and others concerned about giving patients early access to unapproved medicines. The panel also approved an amendment requiring the FDA to prioritize generic drug applications when only one company is approved to manufacture a drug.

Senators defeated 13-10 a Sanders amendment that would have allowed prescription drugs to be imported from Canada if overseas manufacturing facilities met FDA guidelines. Some opposition to the Sanders amendment was less on its substance and more on not wanting to weigh down the user fee bill with controversial language that could delay or scuttle its approval. Sanders says his amendment would allow cheaper drugs to be sold in the United States, but the pharmaceutical industry and several committee members warned of safety concerns about foreign-sourced drugs.

In an effort to placate committee Democrats, the panel's chairman, Sen. Lamar Alexander (R-Tenn.), pledged to hold a future hearing on drug prices. Sanders and others are likely to press the drug pricing issue when the user fee legislation is considered on the Senate floor.

Current user fees expire September 30. Congress is pushing to pass a renewal before the end of July. The House Energy and Commerce Health Subcommittee on Thursday approved its version of the bill.

Senate Health Discussions Continue as CBO Score Nears

Senate Republicans continued their behind-the-scenes discussions about how to change the House-approved legislation repealing and replacing the Affordable Care Act (ACA).

A group of more than a dozen GOP senators are involved in active discussions, including several meetings last week. But other, smaller groups of lawmakers also are meeting to trade ideas and share proposals, including provisions on Medicaid, tax credits to encourage low-income Americans to purchase insurance, essential health benefits and pre-existing conditions protections.

At issue is how to fulfill a long-held Republican campaign promise of repealing the ACA but also address senators' concerns about states that expanded Medicaid coverage as well as House language that could jeopardize coverage of pre-existing conditions for those seeking to purchase insurance on the individual market.

Senate leaders continue to say major changes in the House-approved bill are likely as they work to create a majority of at least 50 senators to support a bill. Republicans hold 52 Senate seats, and Vice President Pence would cast a tie-breaking vote.

Before they can seriously negotiate detailed changes, senators need an economic analysis of the House bill by the Congressional Budget Office (CBO). Because of the Senate's budget rules, only certain provisions are allowed to be included in the healthcare bill, and the Senate bill also must meet certain fiscal benchmarks. CBO isn't likely to release its score of the House bill until next week.

House Speaker Paul Ryan and the U.S. Department of Health and Human Services (HHS) Secretary Tom Price last week said they anticipated the Senate would approve its bill before Congress adjourns in late July for a month-long recess. But how Senate leaders navigate the thorny policy and political issues won't begin to become clear until after the CBO score of the House bill is released.

Governors Call on Congress to Quickly Approve CHIP

In a letter to Capitol Hill, the National Governors Association urges speedy renewal of the Children's Health Insurance Program (CHIP), but lawmakers are unlikely to act on reauthorizing the program until after Labor Day. The governors' letter says CHIP has dramatically reduced the child uninsured rate, from 15 percent in 1997 when the law was created to less than 5 percent today. The letter was addressed to the leaders of the Senate Finance Committee and the House Energy and Commerce Committee. CHIP expires September 30.

Governors hoped CHIP could be reauthorized by June, when many states finalize their budgets. But Energy and Commerce Health Subcommittee Chairman Mike Burgess (R-Texas) says passage in September is more likely. The delay is mostly because key healthcare leaders are focused on efforts to repeal and replace the ACA. But some Republican lawmakers have suggested leveraging CHIP's bipartisan support to attach to it other healthcare provisions, such as allowing insurers to sell policies across state lines, that couldn't be included in the GOP's broader healthcare overhaul.

Senators Seek Support for Children's Hospital Education

Two senators are seeking support from their colleagues to boost funding for the training of pediatric medical residents through the Children's Hospitals' Graduate Medical Education program. Sens. Sherrod Brown (D-Ohio) and Johnny Isakson (R-Ga.) are circulating a draft letter to leaders of the appropriations subcommittee that funds federal healthcare programs. So far, mostly Democratic senators have agreed to sign on; besides Isakson, the only other Republican is Sen. David Purdue (R-Ga.).

The education program – funded at $295 million this year – is designed to strengthen the pediatric healthcare workforce. Through the program, created by Congress in 1999, 57 hospitals use the funding to train more than 6,000 pediatric providers, addressing critical shortages in pediatric specialty care and improving children's access to healthcare, according to the Children's Hospital Association.

Trump Budget Expected to Call for Health Cuts

The White House is expected to release its fiscal 2018 budget request to Congress next week, and lawmakers say they're anticipating steep cuts in entitlement healthcare programs as President Trump seeks to balance the budget in 10 years. Although the administration's budget submission is an important indicator of presidential priorities, Congress isn't obligated to enact them. In fact, earlier this year the Republican Congress rejected Trump's call for cutting billions of dollars from NIH.

Trump has said Medicare is off limits to changes, but lawmakers say they're anticipating cuts to income-linked healthcare programs, potentially including Medicaid and CHIP. Discretionary spending – on everything from education to transportation – has largely been held flat in recent years. The only way to balance the budget in 10 years without raising taxes – even assuming robust economic growth – would be to reform entitlement spending.

Meanwhile, the House is in the beginning stages of drafting a budget blueprint for fiscal 2018. The appetite for reforming entitlement programs such as Medicare and Medicaid to rein in government spending has been strong among congressional Republicans, including when Speaker Paul Ryan served as chairman of the Budget Committee. It's not clear whether Trump's opposition, at least on Medicare – as well as the ongoing battle over repealing the ACA – could change the GOP's position on healthcare-related entitlement programs.

BakerHostetler's "Capitol Hill Healthcare Update" is distributed weekly when Congress is in session. To access previous postings, please see the Health Law Update Blog.

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.

Authors
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
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must 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.

Disclaimer

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.

General

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