United States: Capitol Hill Healthcare Update - December 1, 2016

House Passes Cures Legislation

After months of debate and partisan wrangling, the House on Wednesday voted 392-26 to pass the "21st Century Cures" bill designed to accelerate the development of new drugs and medical devices as well as increase federal funding for biomedical research. The Senate is expected to give the bill final congressional approval next week before lawmakers recess for the year. The legislation would authorize $4.8 billion over 10 years to the National Institutes of Health (NIH), including $1.8 billion for Vice President Biden's "Cancer Moonshot" project, $1.5 billion for NIH's BRAIN initiative to study diseases like Alzheimer's, and $1.5 billion for NIH's Precision Medicine Initiative. The Food and Drug Administration (FDA) would be eligible for an additional $500 million over 10 years, and states could apply for $1 billion in federal grants over two years to address opioid abuse. None of that money is guaranteed, a key concession by Democrats after November's Republican election sweep. Funding will be subject to annual congressional approval.

Earlier versions of the bill required stakeholders to provide offsets for the new spending, including one that would have forced companies with drugs subject to the FDA's Risk Evaluation and Mitigation Strategies to make the products available to generic manufacturers. But all industry payfors were ultimately dropped, and the bill's new spending instead will be paid for by sales from drawing down the U.S. strategic petroleum reserve and cutting $3.5 billion from the Affordable Care Act's prevention fund.

The Cures effort began in 2015 with sweeping goals of accelerating the discovery and approval of revolutionary new treatments, backed up by new exclusivities for drug manufacturers and guaranteed reimbursements for device makers. But most of those provisions were dropped as the partisan debate over drug prices hampered efforts in Congress to win approval for regulatory and reimbursement policies favorable to industry.

The final Cures bill would establish a review pathway at the FDA for biomarkers, increase patient participation in the drug-approval process, and require the FDA to evaluate real-world evidence to support new uses for previously-approved drugs. It also would streamline the review process for combination products that include both a drug and device, and allow the FDA to accelerate approval of regenerative therapies to heal damaged human cells, a measure pushed by Senate Majority Leader Mitch McConnell (R-KY).

For medical technology manufacturers, the bill would establish a breakthrough device pathway by building on the current priority review pathway. It also would expand the FDA's ability to apply the humanitarian device exemption to devices that treat diseases and conditions that impact up to 8,000 individuals, double the current 4,000 patient limit.

The legislation also would require the FDA's ombudsman to audit and assess the measurements used to track implementation of the so-called "least burdensome" requirements for device makers.

Trump's Picks for HHS, CMS

President-elect Trump announced he is nominating Congressman Tom Price (R-GA) to be secretary of the U.S. Department of Health and Human Services (HHS) and Seema Verma to be Centers for Medicare and Medicaid Services (CMS) administrator.

Rep. Price, an orthopedic surgeon, is chairman of the House Budget Committee and a member of the Ways and Means Committee, which has jurisdiction over CMS. He's been a vocal opponent of the Affordable Care Act and authored "repeal and replace" legislation for the House GOP. Price also was a leading voice in Congress on replacing the Sustainable Growth Rate with the new physician-reimbursement system that will come online next year, and he has been an opponent of competitive bidding for durable medical equipment.

Verma served in Vice President-elect Mike Pence's administration in Indiana in a variety of healthcare roles, and for Pence's predecessor, Gov. Mitch Daniels. She led Pence's effort to expand Medicaid coverage with federal funding as well as assisting with Medicaid redesigns in other states.

Both Price and Verma will require Senate confirmation.

Top Dems Call on CMS to Kill Part B Demo

The top Democrats in Congress are asking CMS not to finalize the agency's sweeping and controversial proposal to test changes to Medicare reimbursements for drugs administered in physician offices. The move by House Democratic Leader Nancy Pelosi (D-CA) and incoming Senate Democratic Leader Chuck Schumer (D-NY) could effectively kill the Part B demo, which was the Obama administration's election-year effort to control drug prices. CMS's innovation center announced the demonstration program in March, but it immediately faced bipartisan criticism on Capitol Hill as well as from the drug industry and some physician and patient groups. Still, CMS hasn't publicly responded to the Democrats' call to scrap the pilot program or told Republican committee staff on Capitol Hill what the agency's next steps may be. Even if the pilot program were finalized before Obama leaves office, the incoming Trump administration could roll it back. Congress could take action early next year to block it, too.

Mylan Won't Testify at Senate Hearing

After Mylan, the U.S. Department of Justice (DOJ) and CMS declined to participate in a Senate Judiciary Committee hearing scheduled for this week. Panel Chairman Chuck Grassley (R-IA) accused the Obama administration of "dodging accountability" and Mylan of "gaming the system." Sen. Grassley is probing Mylan's $465 million settlement with the DOJ for allegedly overcharging Medicaid for its life-saving EpiPen allergy treatment. Mylan declined to send a company witness to the hearing because it is "a pending matter." Grassley said he is considering issuing subpoenas to compel Mylan's testimony. Separately, Grassley also is calling on the U.S. Securities and Exchange Commission to investigate whether Mylan misled investors about the settlement.

Hospitals Call for Changes to Chronic Care Framework

The American Hospital Association last week called for expanding the Senate Finance Committee's draft plan to create Medicare programs to improve coordination and reduce cost for treating chronic conditions. The trade association, which represents nearly 5,000 hospitals nationwide, urged senators to expand access to telehealth by removing restrictions on covered services and technologies. The committee proposed expanding the Medicare telehealth benefit, including coverage of consults for patients experiencing acute stroke symptoms and monthly clinical visits for patients undergoing home dialysis treatment. Hospitals also called for increased regulatory flexibility for doctors' groups that participate in accountable care organizations and for an adjustment to the CMS "hierarchical conditions" risk model to include socio-economic and socio-demographic factors on the cost of care. Led by committee Chairman Orrin Hatch (R-UT), the chronic care proposal is expected to be considered next year in the Senate.

Diabetes Group Wants Probe of Insulin Prices

The American Diabetes Association is calling on Congress to hold hearings on recent insulin price increases. Insulin was discovered in 1921, and its first patent expired 75 years ago. Since then, multiple companies have produced variants with faster-acting or longer-lasting formulations. Insulin prices tripled between 2002 and 2013, the group said, forcing some of the six million Americans with diabetes to ration their medicine. Separately, Sen. Bernie Sanders (I-VT) and Rep. Elijah Cummings (D-MD) have asked the DOJ and the Federal Trade Commission to investigate what they said was collusion among drug companies over insulin prices.

Pelosi, Schumer Vow to Block GOP Medicare Changes

The top Democrats in Congress are warning that Republicans could "privatize" Medicare, signaling they will fight GOP changes to the healthcare system for the elderly and disabled. Republicans have made no secret of their goal next year to advance Medicare changes as part of repealing the ACA. House Speaker Paul Ryan (R-WI) has called for expanding Medicare Advantage plans, allowing beneficiaries to shop for plans other than the traditional fee-for-service Medicare, and for consolidating Medicare Part A and Part B. House Democratic Leader Nancy Pelosi (D-CA) and incoming Senate Democratic Leader Chuck Schumer (D-NY) warned Republicans against over-reaching on Medicare, saying changes could backfire on Republicans and cost them politically in the 2018 mid-term elections.

House Hearing on Preventive Services

The House Energy and Commerce Health Subcommittee on Wednesday held a hearing on bipartisan legislation reauthorizing the U.S. Preventive Services Task Force. The legislation, introduced by Reps. Marsha Blackburn (R-TN) and Bobby Rush (D-IL), would require the task force to ensure balanced and relevant representation of medical personnel on its committees and require members to disclose conflicts of interest. The bill would require specialists to review the preventive services that the task force examines. It also would require the Government Accountability Office to submit a report comparing the task force's recommendations with other federal government health guidelines. It's not likely Blackburn's legislation would be considered by the House before it adjourns this month, requiring the bill to be reintroduced in the 115th Congress in 2017.

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 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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.