FDA and MDCG Release UDI Implementation Guidances

 In Blog, Regulatory & Reimbursement Update


US FDA rolls out final guidance on Unique Device Identifier (UDI) labeling requirements

The FDA has published its long-awaited final guidance on form and content requirements for Unique Device Identifier labeling, superseding draft guidance issued in 2016. The final guidance covers recommendations from FDA to help medical device labelers as well as FDA-accredited issuing agencies that issue UDIs ensure that their labeling efforts comply with the agency’s UDI Final Rule, established in 2013. The final guidance does not veer significantly from its draft version but notably does now include a section clarifying UDI labeling requirements and recommendations for stand-alone medical software / software as a medical device (SaMD).

(EMERGO- July 12, 2021)

MDCG posts guidance on UDI integration within a QMS

The European Commission’s Medical Device Coordination Group (MDCG) issued new guidance providing recommendations for integrating unique device identification (UDI) processes within a manufacturer’s quality management system (QMS) to meet requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). MDCG explains that a UDI implementation plan can help manufacturers make correct assessments and decisions and generate the proper documented evidence to ensure compliance with the regulations regarding the UDI system. Annexes to the guidance provide a list of steps that should be considered when implementing UDI processes into a QMS, an example of a UDI implementation plan, and recommendations for notified bodies on auditing the implementation of the UDI system.

(RAPS 7/15/21)

Medical Device User Fee Rates for Fiscal Year 2022

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2022, which apply from October 1, 2021, through September 30, 2022, and provides information on how the fees for FY 2022 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

(Federal Register 7/31/21)

FDA finalizes long-awaited intended use rule

After multiple delays, the US Food and Drug Administration (FDA) has finalized a rule clarifying its position on the types of evidence it will consider when determining a medical product’s intended use. The new rule also repeals and replaces the unimplemented portions of an earlier final rule on intended uses. The only change from the proposed rule is a modification to the codified language of the intended uses regulation, “to clarify its applicability to devices that are approved, cleared, granted marketing authorization, or exempted from premarket notification.” The final rule is set to take effect on 1 September 2021.

(RAPS 8/2/21)


2022 Physician Fee Schedule proposes expanded remote patient monitoring coverage

The Centers for Medicare and Medicaid Services (CMS) included a new category of CPT codes in the proposed 2022 Physician Fee Schedule that would address “remote therapeutic monitoring”. The new billing codes would add coverage to augment the existing remote physiological monitoring codes. The new codes include remote monitoring of respiratory system status, musculoskeletal system status, therapy adherence and therapy response.  While excited by the prospect of these new codes, industry stakeholders state that the proposed codes are creating a lot of unanswered questions, such as what types of medical professionals can bill using these new codes. This might be an opportunity for physical therapists, occupational therapists and other practitioners who cannot currently bill for remote patient monitoring, however CMS has noted some uncertainty regarding the code structure. Public comment is invited on the proposal until September 13th.

(mHealth Intelligence 7/19/21)

CMS CY2022 Home Health Prospective Payment System Rule proposes increased payments

The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would result in a $310 million payment increase to home health agencies. This 1.7% increase represents a routine update. Also included in the Home Health Prospective Payment System proposal is a home infusion-therapy payment schedule and new initiatives for attaining health equity for patients who live in rural areas and those who are in demographic groups that are adversely affected by persistent poverty or inequality.

(Healthcare Finance 7/8/21)

CMS persists with dramatically reduced rates for long-term cardiac monitoring

The Centers for Medicare and Medicaid Services (CMS) has decided not to set a national price for long-term cardiac monitoring. This decision perpetuates the low rates established by Novitas Solutions, a Medicare rate setter. Industry stakeholders have expressed concern that this payment rate is below the cost of service, but CMS states that it has not received adequate pricing information from cardiac monitoring companies such as iRhythm Technologies. CMS states that representative invoices need to be provided as evidence in order to compel action. Without this information, the low payment rates will continue.

(Med Tech Dive 7/14/21)

The AMA expands seats on CPT editorial panel to increase specialty expertise

The American Medical Association (AMA) is responsible for maintaining the CPT code set used for medical billing. The CPT editorial panel currently consists of 17 members, but will soon be expanding to 21 members. This expansion will include new members from specialty medical societies and is intended to increase the panel’s expertise in the emerging areas of digital health, diagnostic precision, and augmented intelligence.

(AMA 6/21)

The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, RAC, Simbex Senior Quality Assurance/Regulatory Engineer, Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, and Mohammed Kazi, MS, Simbex Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.

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