FDA Issues Pandemic Inspections Guidance & CMS Announces New Payment Rates

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FDA issues pandemic inspections FAQ guidance

FDA issued an immediately effective frequently asked questions guidance explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) pandemic.

For domestic inspections, this means conducting mission-critical inspections on a case-by-case basis or, when it can be done safely, resuming domestic inspections based on priority. 

The FDA defined mission-critical inspections as follows: a product that holds a breakthrough therapy designation or a regenerative medicine advanced therapy (RMAT) designation. Additionally, if a product is used to diagnose, prevent, or treat a serious disease without an appropriate therapeutic alternative.

The FDA addressed concerns regarding manufacturing and supply chain changes for products which are already approved. Lastly, the FDA stated that for products seeking to treat or prevent COVID-19 they must submit submissions identifying “Priority Review Requested” and include supplementary information. (RAPS 8/19/20)

European Commission identifies which Eudamed data to be publicly accessible

Major information targeted for public accessibility within Eudamed includes Registration details of manufacturers, Authorized Representatives and importers; Registration of devices as well as Unique Device Identification (UDI) database elements listed in part B of Annex VI of the MDR; Certificate of conformity registration details; List of Notified Bodies designated under the MDR, along with their identification numbers, conformity assessment activities and lists of their subsidiaries; Expert panel scientific opinions, as well as written justifications for instances where Notified Bodies have not followed pertinent expert panel opinions; Reports and summaries of clinical investigations; Safety and clinical performance report summaries for implantable and Class III devices; Manufacturer incident reports and field safety notices; and Market surveillance activity result summaries from European Union Member States. (Emergo 8/12/20)

FDA finalizes first device-specific safety and performance based pathway guidances

The two final guidances provide performance criteria for cutaneous electrodes for recording purposes and conventional foley catheters. While the 510(k) pathway requires device makers to demonstrate substantial equivalence to a predicate device, FDA says the new optional safety and performance based pathway builds on its abbreviated 510(k) program to give device makers the flexibility to use performance criteria and voluntary consensus standards rather than direct comparison testing against a predicate device to support 510(k) clearance. (RAPS 8/13/20)

Struggling with Quality Compliance? This Pilot Study Is for You

Launched in July, the new Accelerate Sustainable Capability (ASC) pilot study is intended to help manufacturers who have difficulty achieving and sustaining regulatory compliance receive insight to help them improve product quality and safety; reach quality compliance more efficiently; structure their systems for continuous quality improvement. The goal is to test a methodology for providing systemic improvement to enable FDA 483 and/or advisory actions to be closed faster and more sustainably while, at the same time, ensuring objective metrics and residual risk assessments are in place to provide the agency with oversight of product quality throughout the process. (MDDI Online 7/29/20)

Updated European UDI FAQ features revised compliance deadlines

Submission of UDI data to EUDAMED will now be mandatory starting on November 26, 2022 for medical devices and on the same date in 2023 for IVDs, although there is a provision to delay this requirement if the database if not fully functional by the date of application of the pertinent Regulation. The FAQ also includes a table that specifies when manufacturers must begin placing the UDI carrier on labels or performing direct marking of reusable devices, broken down by device class. (Emergo 8/19/20)


CMS Announces an Increase in Payment Rates for Three Types of Facilities 

Inpatient psychiatric facilities, skilled nursing facilities, and hospices will all receive increased payment rates in 2021 from the Centers for Medicare and Medicaid Services (CMS). The rate increases range from 2.2 to 2.4%. For inpatient psychiatric facilities, this is estimated to result in an increase of $95 million. The increase in skilled nursing facilities is projected to be $750 million and the increase in hospice payments will be approximately $540 million. 

With regards to inpatient psychiatric facilities, CMS is working to adjust wage index values so that they may be more representative of the actual costs of labor in respective regions. 

For skilled nursing facilities, CMS is responding to stakeholder feedback by solidifying changes to the ICD-10 code mappings–effective October 1st. ICD-10 code mapping, which covers the price of care based on patient characteristics and not volume, annually considers stakeholder feedback and implements changes on a timely basis.

Specific to hospices, those that fail to meet quality reporting requirements will be subject to a 2% diminution in the annual market basket percentage increase for the FY. The finalized aggregate cap amount for hospices is $30,683.93.

Lastly, these changes, as mandated by legislative requirements, will result in Medicare savings. (Healthcare Finance 8/3/20)

Physical Therapy Alliance “disappointed” by proposed 9% payment cut 

The Alliance for Physical Therapy Quality and Innovation (APTQI) released a statement criticizing CMS for its proposed reduction of payments for physical and occupational services in 2021.  APTQI warns that these cuts could “drive physical therapy providers out of business”. The CMS decision was made despite the advocacy efforts of an American Medical Association-convened workgroup, support from congressional leaders, and a grassroots letter-writing campaign that resulted in almost 11k letters to Health and Human Services. (APTQI 8/4/20)

Not Everyone Can Afford Home Monitoring Devices 

Pennsylvania physicians shared their experiences with remote monitoring devices, observing that cardiology patients were one population that saw an enormous rise in telehealth visits between March and May. The routine check-up visits rely heavily on vital sign readings that are typically taken by clinic staff. Instead, patients had to buy home devices including blood pressure cuffs, heart rate monitors and even home ECG devices. While insurance coverage of telehealth services expanded during the pandemic, there was no equivalent expansion of reimbursement for remote monitoring devices. Leaving them “inaccessible physically and financially for some of our patients”. This raises the concern about a widening of the already substantial health gap between along demographic lines. (Pittsburgh Post-Gazette 8/7/20)

How CMS Changes, Trump’s Executive Order Affect Telehealth Coverage

Several changes to current Medicare coverage include new opportunities for remote patient monitoring and adding nine new billing codes for connected health services. CMS added nine new Telehealth codes to the 2021 list, covering a variety of services:  99347 and 99348 (Home Visits), 99334 and 99335 (Domiciliary, Rest Home or Custodial Care Services), 99483 (Care Planning for Patients with Cognitive Impairment), 96121 (Neurobehavioral Status Exam), 90853 (Group Psychotherapy), 99XXX (Prolonged Services) and GPC1X (Visit Complexity Associated with Certain Office/Outpatient E/Ms). CMS is expanding the telehealth platform to allow supervising physicians – who previously had to be in the building and immediately able to assist in a clinical procedure – to supervise via real-time, interactive, audio-visual telemedicine. (mHealthIntelligence 8/6/20)

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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