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Senators Debate Adding UDI to Claims .pdf



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Related Articles: 5

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Senators Debate Adding Unique
Device IDs To Claims Forms

Senate Panel Passes
Breakthrough Device, Other
Measures; FDA Funding Debated
“The Gray Sheet” Mar. 10, 2016
Scope Firms, FDA Faulted In 300
-Page Senate Report Seeking
Device Reforms
“The Gray Sheet” Jan. 14, 2016
UDI Expands, Questions Roll In,
And Debate Over System
Adoption Continues
“The Gray Sheet” Dec. 17, 2015

By Sue Darcey / Email the Author
Regulatory & Policy News / Word Count: 658 / Article # 01160314018 /
Posted: March 10 2016 6:00 PM

Senators Press CMS To
Incorporate UDI Info Into Claims
Data
“The Gray Sheet” Dec. 29, 2014

Executive Summary

Pew Pushes For Faster UDI
Integration Into Electronic Health
Records
“The Gray Sheet” Apr. 28, 2014

Sen. Patty Murray floated, and then withdrew, an amendment to require that
Unique Device Identifiers be added to insurance claims forms. She plans to
raise the matter on the Senate floor. Both CMS and Sen. Orrin Hatch, who
heads the Senate Finance Committee with jurisdiction over Medicare, have
reservations about the idea.

Key Documents: 1

The prospect of legislation to require CMS to add Unique Device Identifiers to
insurance claims forms was raised at a March 9 Senate committee hearing.

Click a document title to review.

Sen. Patty Murray, D-Wash., asked that the Senate Health, Education, Pensions
and Labor Committee consider adding an amendment to device legislation that was
on the table during the markup session requiring a UDI field in claims forms. HELP
approved seven bills during the session, including a breakthrough device pathway
bill, but without UDI language. (See "Senate Panel Passes Breakthrough Device,
Other Measures; FDA Funding Debated" — "The Gray Sheet," Mar. 10, 2016.)

re UDI and OIG

Murray, ranking member of the committee, withdrew her amendment due to a
compromise with Committee Chairman Lamar Alexander, R-Tenn. But Murray said
she would bring it up again on the Senate floor. “We want to push forward with this
effort,” she said.
Adding UDIs to claims forms might
“strengthen FDA’s ability to rapidly
address infection safety concerns,”
Murray said. It was one recommendation

Sens. Elizabeth Warren, DMass., and Chuck Grassley,
R-Iowa, have prodded CMS

2016 03 08 WarrenGrassley Letter

Topics Covered in
this Article
Click a keyword for related
articles.
General Topics
unique device identifiers
Subjects
Regulatory
Legislation
Reimbursement

https://www.pharmamedtechbi.com/publications/the-gray-sheet/42/11/senators-debate-add... 3/11/2016

Document

that came out of her staff's yearlong
investigation into contaminated
duodenoscopes. (See "Scope Firms,
FDA Faulted In 300-Page Senate Report
Seeking Device Reforms" — "The Gray
Sheet," Jan. 14, 2016.)

Page 2 of 3

to add UDIs to claims forms
in multiple letters to FDA.

Industries
Medical Devices
In Vitro Diagnostics

FDA finalized its UDI rule in 2013 and, since then, a growing segment of devices
have had UDIs affixed in some manner. (See "UDI Expands, Questions Roll In, And
Debate Over System Adoption Continues" — "The Gray Sheet," Dec. 17, 2015.)
Ultimately, however, the agency and public health advocates say, the only way
UDIs can fulfill their potential to improve device safety monitoring and data
collection is if they are fully incorporated into the health care system.
There has been some progress toward making UDIs a routine element in patient
electronic health records. (See "Pew Pushes For Faster UDI Integration Into
Electronic Health Records" — "The Gray Sheet," Apr. 28, 2014.) But CMS and
hospitals have been resistant to moving forward with inserting a UDI field into health
claims, citing cost concerns and questioning the benefit.
In 2014, Sens. Elizabeth Warren, D-Mass., and Chuck Grassley, R-Iowa, sent a
letter to CMS pressing the agency to reconsider. (See "Senators Press CMS To
Incorporate UDI Info Into Claims Data" — "The Gray Sheet," Dec. 29, 2014.) The
senators prodded the agency to put the UDI field into claims forms, again, in a
March 8 letter
to the agency.

Jurisdiction Issue Raised
Legislation would be one approach to forcing the issue, but the path is unclear.
During the HELP markup session, Sen. Orrin Hatch, R-Utah, argued that the matter
falls under the jurisdiction of the Senate Finance Committee, which he chairs.
“The way we would associate unique device identifiers with a device on a
[Medicare] medical claim form is actually a topic under my jurisdiction,” Sen. Hatch
protested. “As chairman of that committee … while we appreciate the hard work, we
ask this committee to refrain from pursuing any legislation that falls within the
exclusive jurisdiction of the committee on finance.”
Hatch also remarked, “If there are concerns on device safety, then you should
consider if a new policy is duplicative of the agency’s existing rules.”
Murray promised to work with Hatch, and the Finance Committee’s ranking member
Ron Wyden, D-Ore., on the issue.
Josh Rising, director of health care programs at the Pew Charitable Trusts’, who
has been a major proponent of adding UDIs to claims forms said it is imperative that
there is some movement on this issue.
“Congress has already instructed FDA to implement an active surveillance system
for devices by expanding the Sentinel program, which relies predominantly on
claims data," Rising told The Gray Sheet. "Expansion of this program won’t be
feasible until Unique Device Identifier data is included in claims, which is why
congressional or CMS action is necessary.

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Page 3 of 3

“Multiple groups of device postmarket surveillance experts have recommended the
development of a 21st century system that relies on real world evidence – including
UDI in claims – to better detect problems and include quality for Medicare
beneficiaries.”
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call
+1 (908) 547-2200 .
Printed by Mr. Norm Rabin, Maetrics LLC

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