IAMERS Counsel Testifies Before Congress in Opposition to the Servicing Bill

Provided below is the link to the hearing held before the House Energy and Commerce Subcommittee on Health on 5/2/2017. The testimony of our general counsel Robert Kerwin and the questions placed by U.S. Congressional members to IAMERS and to MITA are important to our members. To see more about the hearing. Click here.

By |2017-05-02T20:58:01+00:00May 2nd, 2017|Government, Healthcare, Regulatory|Comments Off on IAMERS Counsel Testifies Before Congress in Opposition to the Servicing Bill

New legislation would mandate all ISOs register with FDA

IAMERS Counsel Robert Kerwin to appear on May 2, 2017 before the U.S. House of Representatives Committee on Energy and Commerce on the Legislation. On Tuesday, April 25, 2017, Congressman Ryan Costello (R-PA) and Congressman Scott Peters (D-CA) with the support of the Medical Imaging Technology Alliance, filed H.R. 2118 seeking to require registration of [...]

By |2017-04-28T06:46:04+00:00April 28th, 2017|Government, Legal Advice, Reform, Regulatory|Comments Off on New legislation would mandate all ISOs register with FDA

FDA Holds Off on UDI Label Enforcement for Devices Made Before September 2021

The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021.  In final guidance issued Aug. 30, the agency said stakeholders had expressed concern that pharmacies and other entities in the supply chain were not prepared [...]

By |2016-09-19T08:26:14+00:00September 19th, 2016|Government, Regulatory|Comments Off on FDA Holds Off on UDI Label Enforcement for Devices Made Before September 2021

An in-depth look at the FDA’s refurb docket

Why is this happening now? According to the docket itself, the FDA’s renewed interest in refurbishment came as a response to safety concerns brought to its attention. It’s also a chance to address ambiguities in the way certain terms associated with refurbishment and third-party service are defined. “We hope that this current effort provides additional [...]

By |2016-08-04T20:17:00+00:00August 4th, 2016|Government, Regulatory|Comments Off on An in-depth look at the FDA’s refurb docket

OMB receives CMS rules overhauling Medicaid

The CMS has sent a sweeping finalized rule that will overhaul the managedMedicaid program to the Office of Management and Budget for review. The 653-page proposed version of the rule suggested the biggest changes in Medicaid managed-care regulations in more than a decade. It would cap insurer profits, require states to more rigorously supervise the [...]

By |2016-02-19T13:58:20+00:00February 19th, 2016|Government, Regulatory|Comments Off on OMB receives CMS rules overhauling Medicaid

CMS Administrator Announces End of EHR Meaningful Use Program

Monday, January 18, 2016, Last week, Centers for Medicare & Medicaid Services (CMS) Administrator Andy Slavitt announced that the Electronic Health Records (EHR) Meaningful Use program will “effectively” end and be “replaced with something better.” Read more here.

By |2016-01-19T12:36:47+00:00January 19th, 2016|Government, Regulatory|Comments Off on CMS Administrator Announces End of EHR Meaningful Use Program

Medical Device Tax Suspended for Two Years

President Barak Obama signed a nearly $2 trillion spending package into law on Friday that included provisions to suspend the sales tax on medical devices through 2017. The suspension of the 2.3% tax was part of a larger spending bill that will fund the government through September 2016. Read more here. 

By |2015-12-22T17:41:47+00:00December 22nd, 2015|Business, Government, Regulatory|Comments Off on Medical Device Tax Suspended for Two Years
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