United States: Capitol Hill Healthcare Update - April 25, 2017

No vote this week, but GOP leaders vow action on health bill

Although House Republicans made progress on bridging ideological differences over how to replace the Affordable Care Act (ACA), GOP leaders say not to expect a vote this week as Congress faces a more immediate deadline: The government runs out of money Friday.

Reconvening after a two-week recess, lawmakers are grappling with how to fund competing budget priorities for the remainder of fiscal 2017, including $3 billion for a partial wall along the Mexican border sought by President Trump. GOP lawmakers say they likely will approve a short-term spending bill to keep the government open for another week as underlying budget negotiations continue.

The healthcare discussions are expected to continue, too, as lawmakers learn more about negotiations between House conservatives and moderates during the recess. Rep. Tom MacArthur (R-N.J.), a leader of the moderate Tuesday Group, said last week he reached an agreement on insurance market provisions with Rep. Mark Meadows (R-N.C.), the chairman of the conservative House Freedom Caucus.

The MacArthur-Meadows plan would ensure post-ACA coverage includes pre-existing conditions while also keeping essential health benefits part of a federal standard. Under that plan, states could seek waivers from some federal standards, but no state could waive requirements that young adults be included on their parents' insurance policies, nor rules to prevent denial of coverage based on pre-existing conditions or gender.

The MacArthur-Meadows outline hasn't been translated into legislative text nor vetted with a wider group of GOP lawmakers, so it's unclear whether it could break the Republicans' intra-party logjam that has stalled passage of a bill replacing the ACA. The White House had been pushing for a vote, hoping to trigger House action before Saturday, which marks the end of Trump's first 100 days in office. But after canceling a vote in late March on the American Health Care Act, senior congressional staff say a new vote won't be scheduled until leaders are certain they can pass the bill.

Despite the continued uncertainty on a path forward, GOP leaders say privately they are confident they will eventually secure the votes needed for House approval. Too much of their follow-on agenda, including tax reform, is predicated on replacing the ACA and repealing the law's tax provisions, they say.

Gottlieb vote set for Wednesday

The Senate HELP Committee on Wednesday is scheduled to vote to advance President Trump's nominee to lead the FDA. Dr. Scott Gottlieb is likely to win committee approval and has the strong backing of committee Chairman Lamar Alexander (R-Tenn.). Democrats on the panel have said Gottlieb is too close to the pharmaceutical industry that he would oversee at the agency, and it's possible all committee Democrats may vote against his nomination. If Gottlieb wins committee approval, leadership aides say they hope to schedule a Senate confirmation vote before the Memorial Day recess next month.

Republican introduces REMS bill to address drug prices

A House Republican introduced legislation that would end what he said was brand-name pharmaceutical manufacturers' "manipulation" of an FDA safety program to block competition and thwart lower drug prices. The legislation would compel brand-name companies to make their products available to generic drug makers, including drugs covered by the FDA-mandated safety program Risk Evaluation and Mitigation Strategies (REMS). Critics say innovator manufacturers use REMS to block access to drugs that generic companies need for bioequivalence testing. The House legislation has been introduced before, including in the Senate, but failed to gain traction, as brand-name companies say it would unfairly force them to sell drugs to generic manufacturers, including some that lack the capability of safeguarding high-risk REMS treatments.

What's notable about the House legislation is its new Republican lead sponsor, Rep. David McKinley (R-W.Va.). McKinley is a member of the Energy and Commerce Committee, which has legislative jurisdiction over the FDA. Other Republicans have supported previous efforts to relax REMS safety standards and force drug companies to sell their products to generics, but McKinley is the first GOP lawmaker on a relevant healthcare committee to lead the effort. McKinley's West Virginia district includes Morgantown, where generic manufacturer Mylan Pharmaceuticals has its corporate headquarters.

Bipartisan step therapy bill introduced in house

New legislation introduced in the House would regulate insurers' "step therapy" protocols, giving doctors greater say in the treatments they prescribe for their patients. Introduced by Reps. Brad Wenstrup (R-Ohio) and Raul Ruiz (D-Calif.), the legislation would require health plans to establish a clear process under which physicians could request exceptions to step therapy protocols and require plans to respond to physician requests in a timely manner. It also outlines several conditions under which exceptions to step therapy requirements would be automatically granted.

The lawmakers said step therapy is "a one-size-fits-all policy" that ignores patients' medical histories, overlooks doctors' recommendations and can lead to unnecessary breaks in treatment. The legislation is designed to ensure that a patient's healthcare provider, not an insurance company, makes treatment decisions, they said.

Wenstrup is a former podiatric surgeon, and Ruiz is a former emergency room physician.

Insurers increasingly use step therapy as a cost-containment tool, but in some cases it can have the opposite effect. Patients are often required to try and fail on two or more drugs before a health plan or PBM approves coverage for the medicine originally prescribed. Some plans and PBMs even require patients to first try medicines with black-box warnings.

The bill would only affect employer-sponsored health plans governed under federal law and would not preempt state laws – though several states have enacted similar legislation in recent years.

Grassley questions insurer over brand drug "penalties"

One of the leading Republican voices in Congress on the issue of drug prices is asking CareFirst BlueCross BlueShield why it's charging patients a penalty for certain brand name drugs. CareFirst, one of the largest insurers in the mid-Atlantic, is up-charging patients whose doctors are prescribing brand name drugs when generics are available. Sen. Chuck Grassley (R-Iowa) wants to know why.

Grassley, in a letter to CareFirst, questioned why the insurer is charging a penalty – equal to the difference between a brand drug's price and a generic's price – when a physician has found the brand drug to be medically necessary. Grassley, who is chairman of the Judiciary Committee, said he is looking into whether the practice is commonplace among plans and whether it violates a federal law that requires insurers to waive cost sharing when a physician prescribes a brand drug for medical reasons.

Senate bill would expand telehealth

Bipartisan legislation introduced in the Senate would require the Centers for Medicare & Medicaid Services to test whether telehealth and remote monitoring services can help providers boost health outcomes. The bill was introduced by Sens. Cory Gardner (R-Col.) and Gary Peters (D-Mich.), who said greater use of telehealth services would expand access to healthcare in both rural and urban areas. The legislation would require the U.S. Department of Health and Human Services to allow eligible hospitals to test telehealth services through the Center for Medicare & Medicaid Innovation (CMMI). It would also direct CMMI to order an independent evaluation to assess telehealth models in Medicare Parts A and B. If the telehealth model meets criteria for savings and health outcomes, it would win wider Medicare reimbursement eligibility.

Chronic care legislation introduced in Senate

A bipartisan group of senators introduced legislation that would overhaul how Medicare pays for patients with chronic illnesses. The legislation was spearheaded by the Senate Finance Committee, which undertook a yearlong effort to consider how to improve health outcomes for the more than two-thirds of Medicare beneficiaries living with chronic diseases. The bill would expand the Independence at Home program, which allows seniors with multiple, complex and expensive chronic conditions to receive specialized care at home from a team of healthcare providers. The bill would also allow Medicare Advantage plans to tailor coordination and benefits to specific patient groups, and it would promote the wider use of telehealth services.

For Accountable Care Organizations, the bill would allow certain ACOs to use funds to help patients afford primary care services needed to manage chronic conditions.

The bill is sponsored by the committee chairman, Sen. Orrin Hatch (R-Utah), and the panel's top Democrat, Sen. Ron Wyden (D-Ore).

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
 
In association with
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
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.

Disclaimer

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.

Registration

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.

Cookies

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.

Links

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.

Mail-A-Friend

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.

Security

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.