United States: Capitol Hill Healthcare Update - October 2016

Congress Adjourns, Eyes Election Then Lame Duck

Congress completed work last week on a stopgap budget that keeps the government open until a post-election lame-duck voting session in December, when lawmakers are expected to move on legislation dealing with medical innovation, mental health reform and possibly efforts to stop CMS's proposed Medicare Part B drug demonstration program.

The November 8 election will be a key inflection point not only for determining who will be president and which party controls Congress, but also for forecasting potential healthcare reforms in December and into 2017.

Lame Duck: 21st Century Cures

Shortly before lawmakers left Washington, bipartisan healthcare leaders pledged to advance the medical innovation legislation called "21st Century Cures" during the lame duck voting session. In fact, Senate Majority Leader Mitch McConnell, (R-KY), told reporters he thought Cures "could end up being the most significant piece of legislation we pass in the whole Congress."

But that says more about partisan gridlock that has largely seized Capitol Hill in recent years than it does about the sweeping nature of the bill. Championed by House Energy and Commerce Committee Chairman Fred Upton, (R-MI), the initiative began in 2015 with far-reaching regulatory and reimbursement changes, including a host of new exclusivities for drug companies and automatic coverage for certain new medical devices.

That effort, which met immediate resistance from Democrats, later stalled amid growing criticism over rising prices for both branded and generic drugs. Democrats also insisted on billions of dollars in automatic funding for NIH and FDA, money outside of Congress's ability to review and change priorities.

Upton hopes to revive Cures in December with a slimmed-down version that includes a few billion dollars in new funding for NIH and the White House's Cancer Moonshot initiative, along with modest changes to regulatory approvals and clinical trials. Unresolved is how to offset that new funding with cuts to existing healthcare programs and reimbursements.

Lame Duck: Medicare Part B

CMS is expected to soon publish its final rule on the controversial Part B drug demonstration project, triggering potential congressional action in December. Republicans, the pharmaceutical industry and medical specialty groups want to kill the pilot, hatched by the Center for Medicare and Medicaid Innovation, saying its near-national scope and mandatory participation is a politically-driven effort to address drug prices. Even some Democrats have raised concerns about the rule, calling for it to be scaled back. Democrats' reaction to the final rule – and whether the Obama administration will adopt any of its critics' suggestions – will be a key signal indicating whether any post-election legislative effort to undermine the rule would be bipartisan.

Before leaving Washington last week, 179 House lawmakers wrote to CMS acting administrator Andy Slavitt, calling on him to kill the demonstration. They said the agency has, among other things, failed to adequately consult with stakeholders on Medicare's knee- and hip-replacement bundle model, the Part B drug pilot and CMS's expected cardiac bundled-care model.

Lame Duck: Trans-Pacific Partnership (Exclusivity for Biologic Drugs)

The White House in December, with the election in the rear-view mirror, will push for a vote in Congress on the multi-nation trade agreement known as the Trans-Pacific Partnership. But among the stumbling blocks is a key healthcare provision included in the agreement: eight years of marketing exclusivity for biologic drugs, which receive 12 years of protection in the United States. It's possible the exclusivity language will change after the election, but the White House won't announce it before November.

Even if the exclusivity aligns with U.S. law – a key demand of Senate Finance Committee Chairman Orrin Hatch, (R-UT) – the trade deal faces significant political obstacles on the Hill. In addition to near-unanimous Democratic opposition, the political center of gravity among the GOP also has shifted on trade, fueled in part by Donald Trump's criticism of trade deals, calling into serious question whether it could win congressional approval in December.

2017: Debt Ceiling, FDA User Fees

Healthcare stakeholders will face an early test in 2017, when a key vote on raising the government's borrowing authority may accompany a general deficit reduction package that could include reimbursement and policy changes unfavorable to providers. Washington is expected to reach the debt ceiling in March. No matter who wins the White House, congressional Republicans will want spending cuts in return for raising the debt ceiling. In the healthcare space, Democrats will want to shield beneficiaries from cuts, leaving providers vulnerable to adverse legislation.

After the debt ceiling, Congress will have to renew industry user fees for FDA by next September. Although the branded, generic and biologic drug manufacturers as well as the medical technology industry have agreed with the FDA on user fees and agency performance goals, Congress must approve them – and could include regulatory provisions not agreed to by the industry and the FDA.

Drug prices are likely to remain a politically potent issue into the new year, as congressional investigations will continue into several companies' pricing history for drugs.

Finally, at the end of 2017, the medical technology industry will see its hard-fought two-year suspension of the device tax expire. The industry will battle all year for renewal of the suspension, hoping to be included in any comprehensive tax reform legislation that may be considered. More probably, the issue will be debated at the end of 2017 as Congress considers a series of other expiring tax provisions.

Note to readers: With Congress adjourning, we'll resume our healthcare update with a focus on Capitol Hill activity when Congress reconvenes after the November 8 election.

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.

In association with
Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
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.


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