United States: Clinical Trial And Medicare Provider Quality Improvement Provisions In House Committee 21st Century Cures Discussion Draft

On January 27, 2015, the House Energy & Commerce Committee ("Committee") released a discussion draft of comprehensive medical innovation reform legislation as part of its 21st Century Cures Initiative. According to supporting materials released by the Committee, the key goals of the far-ranging proposals in the discussion draft are to (1) incorporate patient perspectives into the development and approval processes for drugs and medical devices and help address patients' unmet medical needs; (2) build the foundation for 21st century medicine; (3) streamline clinical trials; (4) support continued innovation at our federal public health agencies; and (5) modernize medical product regulation.  Ropes & Gray has recently reported on the key proposals concerning drug and device manufacturers in this draft legislation. In this alert, we highlight provisions that are targeted at clinical research stakeholders, as well as proposals related to Medicare provider quality improvement activities.

Key Proposals Related to Data Sharing

The Committee's section-by-section breakdown of the draft legislation notes that the sections under the subtitle of "Building a 21st Century Data Sharing Framework" would serve to "establish a data sharing framework to enable (1) patients and physicians to better identify ongoing clinical trials, thereby increasing opportunities for patients in need of a treatment; (2) researchers and developers to use Medicare data for the purposes of improving the quality of patient care; and (3) a process for Congress to address other issues identified by the President's Council of Advisors on Science and Technology so that data can continue to fuel all areas of the 21st Century Cures cycle." Significant proposals related to data sharing include the following:

  • Standardization of Data in Clinical Trial Registry Data Bank on Eligibility for Clinical Trials.  The discussion draft requires the Director of the National Institutes of Health ("NIH") to ensure that the clinical trial registry and results databank on ClinicalTrials.gov can be "easily used by the public," and that the information is available in a standardized format that includes criteria for trial inclusion and exclusion, such as International Classification of Diseases ("ICD") or Current Procedural Terminology ("CPT") information. 
  • Clinical Trial Data System.  The discussion draft provides for the creation of a system for sharing data from clinical trials "sponsored solely by an agency of the Department of Health and Human Services"—in other words, government-funded trials rather than industry-sponsored or academic-sponsored trials—that involve an approved or investigational drug, device, or biologic. The organizations that may be funded to host or arrange such a data-sharing system or platform—institutions of higher education or tax-exempt 501(c)(3) organizations—must demonstrate a proven track record of "being a neutral third party in working with medical product manufacturers, academic institutions, and the [FDA]." This provision also requires a certification that a participating organization must "not currently and does not plan to be involved in sponsoring, operating, or participating in a clinical trial nor collaborating with another entity for the purposes of" doing so. This would seem to exclude most major research universities, which generally perform industry-sponsored, self-sponsored, and NIH-funded trials. This provision also expressly addresses privacy concerns of research subjects, setting forth that a participating organization hosting or providing such a data-sharing system must have "a description of the methodologies to be used to de-identify clinical trial data consistent with" current or successor regulations in the Code of Federal Regulations, as well as "a plan in place to allow registered users to access and use de-identified clinical trial data."
  • Expanding Availability of Medicare Data.  The discussion draft permits "qualified entities" to provide (or sell at cost) their Medicare claims data or analyses to certain "authorized users," such as providers of services, suppliers, employers, health insurance issuers, medical societies, or other entities approved by the HHS Secretary. The Medicare information may be used for the purposes of "assisting providers of services and suppliers in developing and participating in quality and patient care improvement activities, including developing new models of care." The provision appears to be designed to enable providers to participate in quality improvement activities, employers to evaluate health insurance options for their employees, and health insurers to compare statistics on their own patients against the Medicare population at large. This proposal also provides for access to Medicare data and, at the HHS Secretary's discretion, Medicaid data by "qualified clinical data registries," which are data registries that allow for reporting of certain data related to the quality of physician services (part of a Centers for Medicare & Medicaid Services ("CMS") initiative that provides reimbursement incentives for physicians that improve quality). Under this proposal, the registries may receive such data "for purposes of linking such data with clinical outcomes data and performing risk-adjusted, scientifically valid analyses and research to support quality improvement or patient safety."
  • Empowering Patient Research and Better Outcomes Through CMS Data.  This provision requires the HHS Secretary to promulgate regulations that would allow government or "qualified researchers" to access de-identified "research-identifiable" CMS data files. For purposes of this provision, "qualified researcher means an individual with the education and experience necessary to design and conduct research properly, as determined by the Secretary, regardless of the individual's commercial or institutional affiliation."
  • Allowing Clinical Data Registries to Comply with HIPAA Privacy and Security Law in Lieu of Analogous Common Rule Provisions. The draft requires the HHS Secretary to "establish an exception" to the Common Rule in regard to the privacy protections for research subjects. Under this provision, clinical trial data registries may, in lieu of complying with the Common Rule in this area, choose to comply with the Health Insurance Portability and Accountability Act ("HIPAA") privacy and security provisions.
  • Commission on Data Sharing for Research and Development.  This provision provides for the creation of a "Commission on Data Sharing for Research and Development" (the "Commission") by the HHS Secretary, with members to be appointed by the Secretary and congressional leaders. The purpose of the Commission is to provide recommendations to Congress on the following topics: (1) the development of a method by which health information about individuals participating in government health care programs (e.g., Medicare) or exchanges established under the Patient Protection and Affordable Care Act ("PPACA") may be shared with "qualified entities," which are organizations established under the PPACA to receive Medicare claims data from HHS for the purpose of evaluating provider/supplier performance; and (2) the development of a process for establishing a registry of clinical data.
  • Recommendations for Development and Use of Clinical Data Registries. The discussion draft provides for the HHS Secretary to make recommendations regarding standards for clinical data registries generally (as opposed to the Commission, as defined and discussed above, which appears to concern itself with the creation of a single registry consisting of data on government payor beneficiaries). This section requires the Secretary to consult with "manufacturers of drugs and medical devices" to seek information regarding how registries may be helpful for diseases treated or managed by their products, thereby providing a potential avenue for industry to participate in the process.
  • Sharing of Data Generated Through NIH-Funded Research.  This provision allows the HHS Secretary to require those receiving a grant or other financial support from the NIH to "share with the public data generated through such research," subject to confidentiality and trade secret protections.
  • Accessing, Sharing, and Using Health Care Data for Research Purposes. This section of the discussion draft amends the Health Information Technology for Economic and Clinical Health Act of 2009 ("HITECH Act") to allow for the use and disclosure of protected health information by a covered entity for research purposes in a variety of circumstances. For example, one provision requires the HHS Secretary to authorize the disclosure of protected health information for research activities, including comparative effectiveness studies, similar to the disclosure that is permitted for public health purposes. This section also allows individuals to submit a "one-time valid authorization for the use or disclosure of protected health information of the individual with respect to all future research purposes," if certain informed consent requirements are followed.

Other Proposals Relevant to Clinical Research Stakeholders and Medicare Providers

As noted in Ropes & Gray's prior Alert, the discussion draft also includes a series of proposals to modernize clinical research regulations by clarifying the roles of central and local institutional review boards, minimizing overlap in the regulatory requirements applicable to human subjects research, and establishing a framework for companies to incorporate adaptive trial designs and Bayesian and other statistical methods into an effort to improve the efficiency of clinical trials.

Finally, the discussion draft contains several open-ended proposals relating to "Continuing 21st Century Innovation" at federal public health agencies, including the following proposals:

  • Improve the Medicare Local Coverage Determination Process by reforming the Medicare local coverage determination process. The discussion draft itself asks the question "are there ways in which the [national and local coverage determination] process can work better for both the administration and those seeking coverage under the Medicare program?" The discussion draft also suggests provisions for seeking public comment in developing the local coverage determination processes that Medicare Administrative Contractors must follow, and the procedures that must be followed if a contractor issues a revised coverage determination.
  • Advance Telehealth Opportunities in Medicare by requiring the Secretary to implement a methodology to provide for coverage and payment for certain telehealth services (such services to be defined based upon considerations listed in the discussion draft) to the same extent, and in the same amount, as would be provided for services performed in person.
  • Promote Medicare Price Transparency Regarding Site-of-Service by establishing a searchable public website that provides Medicare beneficiaries with a list of items and services, the providers within a geographic area at which such treatments and services may be provided, and cost information associated with each item or service at each site.
  • Prevent the Implementation of the "Global Surgery Services Rule," preventing the Secretary from implementing or enforcing a rule that does away with bundled payments for surgeons.
  • Require CMS to Consider the Effects of Medicare Payment Changes on Provider Consolidation by requiring the Secretary to seek and evaluate public comment regarding the extent to which, and how, any proposed change to Medicare payment systems would affect provider consolidation.


The discussion draft represents only an early stage in the legislative process.  Supporting materials released by the Committee emphasize the open-ended nature of this early draft legislation, stating that "[t]he release of the 21st Century Cures discussion document marks a new point in the discussion, but it is one that is far from over. Prior to introduction and throughout the legislative process, the committee requests specific feedback from all interested stakeholders about how to improve the legislation." As described in Ropes & Gray's prior Alert, the legislation has not yet been formally introduced in the House; the Senate's efforts are even more preliminary; and it remains to be seen what reforms Congress will be able to enact in the near term.

Ropes & Gray will continue to monitor developments related to this initiative.

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.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


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.