What's New

Update 10/13/2016

NEW rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. effective January 2018.

A final rule was issued on 9/21/2016 by the National Institutes of Health, Department of Health and Human Services effective on January 18, 2017.

The final rule covers requirements for the submission of clinical trial registration and results information to the ClinicalTrials.gov database. It includes expanded requirements for the submission of clinical trial registration and results information, as authorized by section 402(j) of the PHS Act, to improve public access to information about certain clinical trials of FDA-regulated drug products (including biological products) and device products. However, the rule does not impose requirements on the design or conduct of clinical trials or on the data that must be collected during clinical trials. Instead it specifies how data that were collected and analyzed in accordance with a clinical trial's protocol are to be submitted to ClinicalTrials.gov.

Links with information on the rule:

Update 11/11/2014

Effective January 1, 2015, the Centers for Medicare & Medicaid Services added criteria for coverage of  investigational device exemption (IDE) studies that changed from local Medicare administrative contractor (MAC) review and approval to a centralized review and approval. Learn more (cms.gov)

Update 11/11/2013

Reporting of clinical trial number on claims will be mandatory. Therefore, this information will now be requested on the Enrollment Form.

Effective January 1, 2014, The Centers for Medicare & Medicaid Services (CMS) will require inclusion of an 8-digit clinical trial number on claims associated with clinical trial participation. Clinical trial related claims submitted to Medicare for dates of services on or after January 1, 2014, will be returned to the provider if the 8-digit clinical trial number is not present.

The 8-digit clinical trial number, also called the National Clinical Trial (NCT) Number or Clinical Trials Identifier, can be found on the ClinicalTrials.gov website. The sponsor of the clinical trial, which can include the principal investigator, is responsible for registering the clinical trial with ClinicalTrials.gov within 21 days of enrollment of the first participant. The 8-digit clinical trial number is assigned and released 2-5 business days after the clinical trial information has been submitted. This 8-digit clinical trial number will be added to the list of other required data:

  • QO & Q1 Modifiers as applicable (Outpatient claims only)
  • ICD-9 Diagnosis Code V70.7 (Examination of a participant in a clinical trial)
  • Revenue Code 0624 for FDA Investigational Devices, as applicable
  • Condition Code 30 (Institutional claims only)

Revised enrollment forms and updated encounter Forms are now on the website and should be utilized effective immediately. Please discard all older versions as you will be asked to re-submit using the new forms only.

Please review the new information regarding IDE requests for RI Jurisdiction K A/B MAC Transition which includes a new address:

J14 A/B MAC
NHIC, Corp. - J14 MAC - Special Part A / Part B Message
September 23, 2013

Jurisdiction K A/B MAC Transition: Investigational Device Exemption Requests

Attention: Massachusetts, Maine, New Hampshire, Vermont, and Rhode Island Part A and Part B Providers

NHIC, Corp. currently reviews investigational device exemption (IDE) clinical study requests from both hospitals and physicians in the New England (J14) region which includes the states of MA, ME, NH, VT, and RI. Providers participating in an IDE clinical study and who anticipate filing Medicare claims must notify their Medicare contractor in advance. This applies to:

  • All IDEs assigned an identifying number beginning with a 'G' and a Centers for Medicare & Medicaid Services (CMS)Category B (B1, B2, B3, or B4) by the Food and Drug Administration (FDA);
  • Category A IDE device clinical study before billing routine costs of clinical studies involving a category A device;
  • Post-market approval studies or registries of carotid stents; and
  • Studies for proximal embolic protection devices (EPDs) in carotid artery stenting (CAS) procedures.

Notice is not required for humanitarian use devices, post-market approval studies or registries of devices other than carotid stents, or clinical studies other than those described above. IDE request determinations (approval or denial) are retroactive to the date the documentation to complete the request is received by NHIC, Corp. or the effective date of the Institutional Review Board (IRB) approval, whichever is later.

National Government Services (NGS) is the contractor for the new Jurisdiction K A/B Medicare Administrative Contractor (MAC) and will assume responsibility for the New England region (MA, ME, NH, VT, and RI) on October 18, 2013 for Part A and on October 25, 2013 for Part B. NHIC, Corp. will provide NGS with an updated list of all previously approved/denied IDE requests for both Part A and Part B providers. Both Part A and Part B provider IDE clinical study requests will not be processed by NHIC, Corp. after October 04, 2013. Any current requests which are in process will be finalized if all documentation is received by October 3, 2013. Otherwise, MA, ME, NH, VT, and RI providers will have to reapply to National Government Services (NGS). All new or renewal IDE clinical study requests submitted after October 4, 2013 from facilities and providers in MA, ME, NH, VT and RI shall be emailed to:

NGS-IDE-Request@wellpoint.com

Email is preferred, but you can also fax requests to: (717) 565-3432 or mail request to:
National Government Services, Inc.
Medical Policy Unit
ATTN: Lauri Sersch, CPC - IDE Request
P.O. Box 7108
Indianapolis, IN 46207-7108

Training

Did you know that effective January 1, 2012 a COVERAGE ANALYSIS (CA) needs to be created by you and submitted to the Research Billing Compliance Manger, Deb Temple for all new studies meeting the following requirements?

Required for any research study that interacts with subjects when that interaction could generate a charge such as a clinic visit, lab draw, EKG, x-ray, CT, MRI, etc…Under the current Medicare rules, there is no way around reviewing the details of each research study in order to find out what is billable to Medicare and what is not!

Kelly Willenberg, an outside consultant, held training sessions on how to complete the COVERAGE ANALYSIS early in October 2011 and we have posted the sessions on the Research Administration website for reference, but for anyone who would like more in-depth instruction, Deb Temple will be holding training sessions on Thursday mornings, from 8-9:30 in the Aldrich 5 conference room.

Bring your study information (protocol including a schedule of events, external budget, draft informed consent, etc...) and she will take you through the process. The CA TEMPLATE we will be using can be located on our website along with the QUALIFYING CLINICAL TRIAL (QCT) DETERMINATION FORM.

Past News