United States: 5 Health Care Policy Issues To Follow In 2018

We hope you recharged over the holidays, because we expect health care policy to remain at the forefront as the 115th Congress enters its second session. Both chambers returned on Wednesday after which they will have a scheduled 108 days in the U.S. House of Representatives and 156 days in the U.S. Senate before the mid-term elections. While congressional Republicans safely hold the majority, we anticipate strong efforts to advance their legislative agenda.

Here are the top five health care policy issues to watch for in 2018:

Affordable Care Act "Repeal and Replace"

Expect Congress to make at least one last push to repeal the Affordable Care Act. While Republicans made strides in 2017, they have not fully delivered on their campaign trail promise to "repeal and replace" the ACA.

Congress ended the year by repealing the individual mandate, a central element of the ACA. Under the Tax Cuts and Jobs Act (TCJA), starting in 2019, the penalty for an individual's failure to maintain minimum essential coverage will be reduced to zero. House Speaker Paul Ryan, R-Wis., has vowed to continue pursuing full-scale repeal in 2018, as many of the conference's key priorities remain.

In addition to ACA repeal, we anticipate that Congress will consider legislation that would stabilize the ACA individual marketplace early in 2018. Sen. Susan Collins, R-Maine, had conditioned her vote on the TCJA on passage of two market stabilization bills – the Bipartisan Health Care Stabilization Act and the Federal Reinsurance Act – before the end of 2017. Given the tight timeline and a potential government shutdown right before Christmas, she agreed to push the measures to January.

It is likely, however, that health care reform will face similar challenges as experienced this year, including partisan tensions and intraparty disagreements. Further complicating efforts is Republicans' narrowed majority, with Sen. Doug Jones, D-Ala., replacing Sen. Luther Strange, R-Ala., in the chamber. Even if leadership chooses, once again, to pursue reforms through budget reconciliation – which requires 50 votes in the Senate (as opposed to 60) – Senate Republicans will be able to afford only one defection.

Entitlement Reform

Another contender for budget reconciliation is entitlement reform, which Ryan has indicated that he plans to pursue in 2018. The Medicaid program, which is projected to account for approximately $385 billion of federal spending in 2017, will be a prime target.1

We expect to see policies aimed at controlling federal spending and shifting authority from the federal government to the states. Proposals will likely be similar to those included in the House-passed American Health Care Act and other ACA repeal and replace measures, such as phasing down Medicaid expansion, as well as shifting Medicaid financing from a federal-state match to a state block grant or per capita allotment.

Prescription Drug Pricing

The rising cost of prescription drugs has intensified, drawing attention and fire across the political spectrum and in the media. This year, legislators introduced over 25 bills and several congressional health care and oversight committees held hearings to investigate the issue. We expect that congressional attention on this issue will continue in 2018.

While the parties have generally not been aligned on drug pricing reforms, proposals aimed at increasing competition have attracted bipartisan interest. The U.S. Food and Drug Administration Reauthorization Act of 2017, which nearly unanimously passed both chambers, codified an expedited pathway for certain generics if the secretary determines that there is "inadequate generic competition." Additionally, during a recent Senate Health, Education, Labor, and Pensions Committee hearing, bipartisan members voiced support for addressing anti-competitive practices in bringing generics and biosimilars to the market, as well as prohibiting pay-for-delay agreements.

340B Drug Pricing Program

2018 could be the year that Congress enacts reforms to the 340B Drug Pricing Program. Over the past several years, the 340B program has been marked by considerable uncertainty, driven, in part, by tension over the intent of the program and debate over the Health Resources and Services Administration's (HRSA) oversight and regulatory authority over the program.

The House Energy & Commerce Committee has taken the lead on 340B reform, with its Oversight Subcommittee expected to release a report on 340B early next year. Committee members, Reps. Chris Collins, R-N.Y., and Buddy Carter, R-Ga., have been developing comprehensive 340B reform legislation, which could codify many unresolved issues, including the scope of HRSA's oversight and regulatory authority, the definition of a "patient," and the original intent of the 340B program.

More immediately, if not addressed before the end of this year, we anticipate efforts to roll back CMS's 2018 outpatient prospective payment system (OPPS) final rule, which starting on Jan. 1, 2018, will reduce reimbursement for certain separately payable, non-pass through Part B drugs purchased under the 340B program. Legislation, which would block implementation of the Medicare payment cuts for drugs purchased under the 340B program, has strong bipartisan support. 2

Opioids

Rates of opioid misuse and addiction continue to skyrocket, with the National Institute on Drug Abuse (NIDA) estimating that over 91 Americans die from an opioid overdose each day. 3 The White House declared the opioid epidemic a national emergency in October, and there is broad agreement among policymakers that increased funding and policy solutions are needed.

Two signature achievements of the 114th Congress – the Comprehensive Addiction and Recovery Act (CARA) of 2016 and the 21st Century Cures Act – authorized federal grants to states to supplement opioid abuse prevention and treatment activities, including improving prescription drug monitoring, training for health care providers, and expanding access to opioid treatment programs. The 21st Century Cures Act provided funding authorization for such programs during the 2017 and 2018 fiscal years.

Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Lamar Alexander, R-Tenn., has called for additional funding, though it remains unclear how much Congress will authorize and appropriate. In addition to funding, we expect lawmakers to explore policy solutions, which could include requiring health care providers who prescribe opioids to complete continuing education, expanding the Drug Enforcement Administration's enforcement authority, and strengthening requirements for state prescription drug monitoring programs.

Potential Legislative Vehicles

There will be no shortage of legislative vehicles for these policies, as several federal health care programs will be up for reauthorization next year. Programs set to expire at the end of the 2018 fiscal year include:

Pandemic and All-Hazards Preparedness Act

Legal authorities designed to prepare the United States and health professionals for pandemic, epidemic or biological, chemical, radiological, or nuclear accidents and attacks are set to expire at the end of fiscal year 2018. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 improved the nation's preparedness for public health emergencies. However, our vulnerability to natural and intentional public health threats remains high, as evidenced by the Ebola and Zika outbreaks and reports of enhanced biological weapon capabilities by state actors such as North Korea, combined with the challenge of increased antimicrobial resistance. Congress will need to turn to funding for medical countermeasures such as vaccines, drugs, therapies and diagnostic tools necessary to address public health emergencies and programs that protect Americans and the global community from health security threats.

President's Emergency Plan for AIDS Relief

The creation of the president's Emergency Plan for AIDS Relief (PEPFAR) in 2003 was a landmark in bipartisan congressional commitment to combatting the global HIV/AIDS, tuberculosis and malaria epidemics. Congress reauthorized the program with bipartisan support in 2008 and 2013. PEPFAR funding constitutes the bulk of U.S. global health funding of global health programs and reflects the largest commitment by any nation to address a single disease in the world. The current strategy aligns with the United Nation's AIDS framework, focuses on reducing HIV infections among adolescent girls and young women in 10 sub-Saharan African countries, and emphasizes accelerating testing and treatment strategies, expanding prevention, engaging with faith-based organizations and the private sector, and strengthening policy and financial contributions by partner countries. Program authorities expire at the end of this fiscal year.

Health Care Workforce Programs

Several key health care workforce programs administered by the Health Resources and Services Administration under the Public Health Service Act have expired, and are likely to be reauthorized in 2018. These include health professions and nursing workforce development programs, the Children's Health Graduate Medical Education program, and the Teaching Health Center Graduate Medical Education programs. These programs have traditionally enjoyed bipartisan support in both chambers.

We hope you got some rest, 2018 is sure to be a busy year for health care attorneys.

Originally published in Law360

Footnotes

1. Projections for Major Health Care Programs for 2017, Congressional Budget Office (last updated June 2017). Available at: https://www.cbo.gov/topics/health-care.

2. H.R. 4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes.

3. Opioid Overdose Crisis, National Institute on Drug Abuse (revised June 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.

Authors
 
In association with
Related Topics
 
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