FDA Seeks Increased Oversight of Medical Device Cybersecurity and New HCPCS Codes Issued for Medical Devices

 In Blog, News, Regulatory & Reimbursement Update


FDA seeks more power for medical device cybersecurity mandates

FDA is seeking “additional legislative authorities” meant to bolster medical device cybersecurity amid growing ransomware and other cyberattacks on healthcare organizations, according to Suzanne Schwartz, director of CDRH’s Office of Strategic Partnerships and Technology Innovation. The agency wants to require MedTech upfront, as part of a premarket submission, to have a Software Bill of Materials (an electronically readable format designed to provide an inventory of third-party components in devices, and other provisions to better safeguard them against new and emerging cyber threats) and the capability to update and patch device security into a product’s design. In addition, FDA wants new post market authority to require that manufacturers adopt policies and procedures for coordinated disclosure of cybersecurity vulnerabilities as they are identified.

(MEDTECHDIVE- 17 August 2021)

Proposed US FDA program targets medical device supply chain shortages

A new program proposed by the US Food and Drug Administration would bolster domestic supply chains for medical devices during public health emergencies but would also entail additional compliance work for manufacturers. The Resilient Supply Chain and Shortages Prevention Program (RSCSPP), proposed in FDA’s FY 2022 budget, would be established within FDA’s Center for Devices and Radiological Health (CDRH). According to the agency, the RSCSPP will improve US domestic medical device supply chains by investing money and resources in preventive measures, identifying potential shortfalls of devices and conducting ongoing surveillance and rapid interventions as needed.

(EMERGO- 04 August 2021)

UKCA marking delay: What it means for medical device and IVD manufacturers

On August 24 the UK government announced that mandatory UKCA marking for all products other than medical devices and IVDs would be delayed by one year, to January 1st, 2023. A reason has not been given, but sources in industry indicate this is due to manufacturers not being able to comply in time. This could have resulted in serious shortages of all sorts of supplies had original compliance timeframes been left in place. For medical devices and IVDs, the requirement for UKCA marking still stands at July 1, 2023.

(Emergo 8/25/21)

Clinical trial site remote monitoring may suffice: Updated FDA guidance

a new question and accompanying answer (Q and A) have been appended to the final guidance document about the conduct of clinical trials during the public health emergency of the COVID-19 pandemic. As with other regulatory processes, FDA advises that the sponsor should use an ongoing assessment of risk to drive the answer to the question of whether a new, onsite monitoring visit is required at a given clinical trial site. However, the new addition to the guidance does not specify that a clinical trial site must undergo on-site monitoring if concerns are not triggered by the sponsor’s risk assessment.

(RAPS 8/31/21)


New HCPCs code issued for digital pain and migraine device

Theranica, digital therapeutics and electrocueticals company, was assigned a new level II Healthcare Common Procedure Coding System (HCPCS) code. The new code, K1023 – “distal transcutaneous electrical nerve stimulator, stimulated peripheral nerves of the upper arm”, was issues for established by The Centers for Medicare and Medicaid Services (CMS) and will be effective on October 1, 2021. Theranica CEO, Alon Ironi commented “We are pleased with this CMS decision. We are dedicated to delivering safe, effective, first-line, non-pharmaceutical treatments to people living with migraine, and this new unique code is a significant step in making this therapy affordable for them.”

(Markets Insider 8/16/21)

A new HCPCS reimbursement code is added for wearable lymphedema compression device

The Dayspring system is a product of Koya Medical that provides wearable, active, compression therapy for patients with lymphedema. The product includes a smart, hand-held controller and a mobile app that allows users and clinicians to track patient progress. The Centers for Medicare and Medicaid Services (CMS) has decided to issue a new level II Healthcare Common Procedure Coding System (HCPCS) code KXXXX for the product which will allow for billing of the device. The preliminary coding recommendation was made during the July 2021 HCPCS public meeting.

(Koya 8/10/21)

CMS extends NTAP for 13 technologies due to COVID

The Centers for Medicare and Medicaid Services (CMS) has added a one-year extension to New Technology Add-on Payments (NTAP) for 13 products. The reason for the extension is that CMS had to use financial data from FY 2019 in the calculation of the FY 2022 internal prospective payment system order to avoid the anomaly of the COVID-19 public health emergency. CMS generally uses the most recently available claims and cost report data to set payments. The NTAP payments for new technologies require CMS to pay the DRG payment rate plus up to an additional 75% of the cost for the new technologies for two or three years after product launch.

(MDDI 8/4/21)

Exalt duodenoscope receives additional reimbursement

Boston Scientific announced that The Centers for Medicare and Medicaid Services (CMS) have granted a New Technology Add-on Payments (NTAP) for their Exalt single-use duodenoscopes. Single use scopes are designed to reduce the risk of infection. The Exalt product was designated as a breakthrough device by the FDA and was eligible for transitional pass-through payment in the outpatient setting. The NTAP payments are set to begin on October 1, 2021, when the product is used on eligible cases in an inpatient setting.

(PRNewswire 8/2/20)

CGS quarterly report shows that the CMS contractor denied 65.52% of knee orthosis claims

Celerian Group Company (CGS), a Centers for Medicare and Medicaid Services (CMS) contractor, released a report with analysis from claim denials between April and June 2021. The report states that 65.52% of claims for knee orthoses (L1833 and L1851) were denied. Lack of clinical documentation of knee instability was the top reason for denial, responsible for 43% of denied claims. In order for a knee orthosis to be considered medically necessary, the patient’s medical record must include a description of joint laxity as found during examination by manual testing such as anterior/posterior draw or varus/valgus testing). Test results must be included within the treating practitioner’s notes.

(CGS 8/23/21)

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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