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Medical Devices › Rulemaking Process › Centers for Medicare & Medicaid Services (CMS)

Hogan Lovells

FDA to rescind laboratory developed test rule

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FDA decided to rescind the LDT rule after declining to appeal a district court decision vacating it. The rule reflected FDA’s latest attempt to regulate LDTs under the same framework as IVDs, which FDA considers medical...more

Holland & Knight LLP

CMS Proposes Transitional Coverage for Emerging Technologies

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The Centers for Medicare & Medicaid Services (CMS) recently issued a long-awaited Notice with Comment Period outlining a proposed Transitional Coverage for Emerging Technologies (TCET) pathway under Medicare that would be...more

Hogan Lovells

HHS proposes to sunset regulations Issued by FDA, CMS, and other regulatory agencies

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Our team wanted to highlight a proposed rule issued by the U.S. Department of Health and Human Services (HHS) on 4 November 2020 - with only a 30-day comment period - that would establish sunset (expiration) dates for...more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

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Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Hogan Lovells

CMS proposes changes to new-technology add-on payment amounts and criteria in the inpatient prospective payment system proposed...

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On 23 April 2019 the Centers for Medicare & Medicaid Services (CMS) issued the inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system proposed rule for fiscal year (FY) 2020...more

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