United States: Capitol Hill Healthcare Update - March 27, 2017

AHCA Autopsy: What Happened, What's Next?

House Speaker Paul Ryan's decision to cancel Friday's vote on the American Health Care Act triggered post-mortem jockeying among vying GOP factions struggling to come to grips with how the party failed to repeal a law it has singularly campaigned against for the last seven years. Republicans' inability to muster a majority of their 237 House members to back Ryan's plan was the result of a combination of factors, including the evolving policy demands of conservative lawmakers as well as the powerlessness of congressional leaders and the White House to persuade the rank and file to stay in line.

Just five months ago, President Trump ran up huge winning margins in most of the congressional districts represented by conservatives, including the 30-member House Freedom Caucus. Those conservatives once feared Trump; they openly fretted about how a single Trump tweet could roil their voters. But during a White House meeting last week, conservatives defied Trump's call to support the bill and instead proposed a series of ever-changing policy demands. They wanted to jettison the 10 essential health benefits the Affordable Care Act (ACA) requires insurers to include in all plans, which conservatives believe are market-distorting mandates that are causing prices to skyrocket. Trump agreed to drop them. But conservatives had more demands, including allowing insurers to charge different premiums based on age, gender and pre-existing health condition.

Ending those policies on community rating and guaranteed issue would have undercut the bill's support from moderate Republicans, who were already distraught over separate Medicaid changes and were backing away from the legislation. Trump denied the Freedom Caucus's last demand, and the group couldn't accept what otherwise would have been seemingly historic conservative policy victories ending most of the ACA and its mandates, repealing nearly $1 trillion in ACA taxes, and overhauling Medicaid.

Can the GOP's plans to repeal the ACA be resurrected? At least in the short term, probably not. Trump and Ryan are signaling that they are pivoting to budget issues and tax reform. Procedurally, the reconciliation legislation that Republicans were using to repeal the ACA will expire as soon as Congress authorizes a new fiscal 2018 reconciliation bill, which GOP leaders plan to use for tax reform. Without the procedural protections of the reconciliation bill, which can't be filibustered in the Senate, Republicans would be forced to persuade at least eight Senate Democrats to vote for any ACA-related legislation.

Trump said last week that he's content to sit on the sidelines while the ACA "explodes," especially in the individual market, where insurers are pulling out and premiums are rising. It's not clear whether the U.S. Department of Health and Human Services (HHS) will try to hasten that explosion through rulemakings or instead prop up the individual market while attempting to forge bipartisan fixes with congressional Democrats.

Despite the Republicans' political implosion, legislating on healthcare is far from over. Before fall, Congress must approve new Food and Drug Administration (FDA) user fee agreements with pharmaceutical and medical device manufacturers as well as reauthorize the Children's Health Insurance Program. Trump also said he wants to work with Democrats, including Rep. Elijah Cummings (D-Md.), on bringing down prescription drug costs.

Still, given the Republicans' seven-year campaign against the ACA, Speaker Ryan's statement when he canceled the repeal vote was jarring: "Obamacare is the law of the land. We're going to be living with Obamacare for the foreseeable future."

Price to Testify on Trump's HHS Budget

HHS Secretary Tom Price is expected to face a bipartisan gauntlet Wednesday when he defends before skeptical lawmakers the Trump administration's proposed deep budget cuts for health and medical research programs. The House appropriations subcommittee that funds HHS and its related agencies scheduled a hearing to examine President Trump's fiscal 2018 budget proposal. Price is the only witness.

Trump is calling on Congress to reduce HHS spending by 18 percent, or about $15 billion from the current fiscal 2017 spending level; cut  funding by $5.8 billion; increase industry FDA user fees and cut congressional appropriations for the agency; and shutter the Agency for Healthcare Research and Quality. Democrats have criticized the spending cuts – especially for NIH – but so have Republicans, including Rep. Tom Cole (R-Okla.), who is chairman of the appropriations subcommittee that funds HHS.

Alexander Praises Gottlieb After Meeting

President Trump's nominee to lead the FDA had a positive meeting last week with the senator whose committee is responsible for confirming Dr. Scott Gottlieb to lead the agency. Senate HELP Committee Chairman Lamar Alexander (R-Tenn.) said he had an "excellent meeting" with Gottlieb and declared him "well-qualified to lead the FDA." Alexander said confirmation hearings would be scheduled after Gottlieb completed required Office of Government Ethics paperwork.

Gottlieb has held several positions within the FDA, including as deputy commissioner. In addition to agency experience, Gottlieb has been on the frontlines of healthcare as a physician and a patient. He trained at the Mount Sinai School of Medicine and is a cancer survivor having been successfully treated for Hodgkin's lymphoma.

Gottlieb isn't likely to win widespread bipartisan support. He's generally an advocate of deregulation and has worked at conservative policy think tanks. Some consumer groups and Democrats have already come out against his nomination.

GOP-Led House Panel Probes Drug Prices

A House subcommittee led by conservative Republicans who opposed their party's effort to repeal the ACA held a hearing last week on drug prices, saying pharmaceutical manufacturers are manipulating regulatory safeguards to drive up prices and block generic competitors. Ostensibly to shed light on the pharmaceutical supply chain, the hearing focused on drug prices and how supply chains and FDA safety mechanisms like Risk Evaluation and Mitigation Strategies (REMS) can be used to increase prices and thwart generic competition. Witnesses included an official from the Association for Accessible Medicines (formerly GPhA), a consumer group and a Johns Hopkins University professor critical of branded drug companies.

The House Oversight and Government Reform Subcommittee on Health is chaired by Rep. Jim Jordan (R-Ohio), one of the founders of the conservative Freedom Caucus. The caucus's current chairman, Rep. Mark Meadows (R-N.C.), also is a member of the subcommittee. The top Democrat on the full committee, Rep. Elijah Cummings (D-Md.), also participated in the hearing, criticizing increases in drug prices and companies that he said were hiding behind FDA safety programs like REMS to block entry of generic drugs.

Dr. Janet Woodcock, who leads the FDA's drug center, told the subcommittee that the agency receives 150 complaints annually from generic manufacturers saying they can't gain access to drugs for bioequivalence testing because of REMS.

Draft Bill Would Give FDA Authority Over Lab-Developed Tests

Two House members last week released draft diagnostics reform legislation that would grant the FDA new regulatory authority over the creation and manufacturing of laboratory-developed tests. Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) are seeking stakeholder feedback on their draft bill by April 7. Both lawmakers are senior members of the House Energy and Commerce Committee, which has jurisdiction over the FDA and previously has released related legislation.

Under the draft bill, in vitro clinical tests would have their own FDA regulatory structure separate from that of traditional medical devices. The legislation would also grant the FDA jurisdiction over test development and manufacturing, with the Centers for Medicare and Medicaid Services maintaining oversight of laboratory operations pursuant to the Clinical Laboratory Improvement Amendments (CLIA) law.

It's not currently clear if the draft legislation can be finalized in time to be included with the separate medical device user fee reauthorization, which Congress is aiming to approve by summer.

House Panel Eyes Medical Device User Fees

The House Energy and Commerce Health Subcommittee on Tuesday will hold a hearing on the FDA's medical device user fee program. Dr. Jeff Shuren, who leads FDA's device center, is scheduled to testify. Other scheduled witnesses include Cynthia Bens of the Alliance for Aging Research; Robert Kieval of CVRx, a Minnesota-based device manufacturer; Patrick Daly of Cohera Medical, a North Carolina-based device manufacturer; and Diane Wurzburger of GE Healthcare. The pending medical device user fee proposal builds on sweeping changes enacted under the current agreement, which called for higher industry user fees in return for stepped-up agency performance and review times. The FDA estimates that the industry fees negotiated in the proposed agreement will average $200 million per year.

Sanders, Cummings Demand Company Pricing Details

Two Democratic lawmakers leading the charge on lowering prescription drug prices are calling on New Jersey-based PTC Therapeutics to release information about the price it will charge for its drug to treat Duchenne muscular dystrophy. Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) sent a letter last week to CEO Stuart Peltz after the company purchased the drug, deflazacort, from Marathon Pharmaceuticals. The two lawmakers in February wrote to Marathon after media reports that the company planned to charge $89,000 per year for the treatment, which they say is currently available outside the United States for $1,000. "We urge you to keep the price of this relatively common steroid at its current importation cost," Sanders and Cummings wrote. "Doing so will allow patients to use deflazacort in combination therapies without going into bankruptcy."

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