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 Topics
Related Articles
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
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.


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.


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