Rx Rehab Exercise Devices Now 510(k) Exempt & First CMS Code for Exoskeletons

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Regulatory News

FDA exempts additional Class II devices from 510(k) requirements

FDA finalized an order to exempt five types of Class II medical devices from 510(k) requirements, including 890.5360 Interactive Rehabilitation Exercise Devices, which the agency says will decrease regulatory burdens on industry for makers of those devices. The latest order specifically lists exempt and non-exempt product codes for five types of devices and details limitations to the exemptions for four of the device types.

(RAPS- 22 July 2020)

FDA looks to resume domestic inspections this month

Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the FDA said it plans to resume on-site domestic inspections beginning the week of 20 July 2020. FDA said it will prioritize which inspections it conducts in the coming months using a new risk assessment system to determine the state- and county-level risk posed by the virus. FDA says the risk level will determine what types of regulatory activities the agency and its partners carry out at the county level: “Mission critical inspections only, all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population and resumption of all regulatory activities.”

(RAPS- 10 July 2020)

US FDA 2020 agenda includes ISO 13485 harmonization, De Novo classification scheme

FDA plans to issue a notice of proposed rulemaking in October 2020 establishing US quality system requirements based more closely on ISO 13485:2016, according to the agency’s Rule List. Expected in September 2020, the final De Novo classification rule will formalize processes, procedures and criteria for manufacturers whose devices do not fall clearly into existing FDA classification categories.

(Emergo 7/21/20)

EC details device assessment capacity amid COVID-19

For the limited number of notified bodies that are designated under the Medical Devices Regulation (MDR) rather than the MDD, new applications for Class Is or Im devices under Annex IX or XIA would take an average of 1-3 months. “It must be stressed that around 10% of notified bodies are not currently accepting applications under this route,” the EC said. Class IIa devices seeking conformity assessment under these annexes could expect the notified body to take from 3-6 months; for Class IIb devices, the time to process the application could extend to 12 months. Most existing clients seeking conformity assessments for Class Is or Im devices under Annex IX and XIA could expect to see an application processed in 1-3 months, while for Class IIa devices the time frame could extend to 6 months, according to the survey. Class IIb devices seeking conformity assessment under these annexes could see applications processed in the 1-6 month timeframe.

(RAPS 7/7/20)

Guidance: FDA holds off on enforcing certain UDI requirements

In the guidance, FDA clarifies that it does not currently intend to enforce standard date formatting, unique device identification (UDI) labeling, or Global Unique Device Identification Database (GUDID) data submission requirements for class I and unclassified devices until 24 September 2022. Direct mark UDI requirements for Class II, III, and life-supporting-/sustaining devices will not be enforced by FDA if the device’s UDI “can be derived from other information directly marked on the device,” according to the guidance. (RAPS 7/6/20)

Payment News

First CMS reimbursement code for Exoskeletons

The Centers for Medicare and Medicaid Services (CMS) has issued a new Level II reimbursement code (K1007) for exoskeletons. In the Healthcare Common Procedure Code System (HCPCS), K-codes are temporary and are used to report supplies and products for which a national code has not yet been finalized. The next steps in the reimbursement process are the establishment of payment rates and the development of coverage policies for exoskeletons.

(ReWalk 7/15/20)

CMS to resume claim audits in August

The Centers for Medicare and Medicaid Services (CMS) has announced that claim audits and prior authorization requirements, which had been temporarily lifted for provider burden relief during COVID-19, will resume in August. The devices affected by this include power mobility devices and support surfaces. More details are available in a CMS memo.

(DJO Healthcare Solutions 7/17/20)

CMS invalidates new continuous glucose sensing codes 

Two new healthcare common procedural codes (E0787, and A4226), which were added in January 2020, have been made invalid after further review by the Centers for Medicare and Medicaid Services. This change is effective in September 2020 and resulted from claim and payment processing complexities. Two existing codes (E0784 and K0554) will now be used to describe continuous glucose monitoring systems.

(DME PDAC 7/21/20)

Transformation of telehealth and other virtual services during COVID

Selma Verma, administrator of the Centers for Medicare and Medicaid Services (CMS), shared data highlighting the impact of telehealth and insights into what policies should remain beyond the public health emergency. Pre-COVID, approximately 13,000 Medicare beneficiaries received telemedicine services per week, in the last week of April 2020, this number was nearly 1.7 million and a total of 9 million beneficiaries had received services between mid-March and mid-June. The most common type of service has been evaluation and management visits (5.8m beneficiaries).

(Health Affairs, 7/15/20)

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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