Global Medical Device Regulators and Payors Adapt in Response to Pandemic
FDA allows expanded use of devices to monitor patients’ vital signs remotely
FDA does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared non-invasive remote monitoring devices that are used to support patient monitoring (hereinafter referred to as “subject devices”) during the declared public health emergency without prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81. (FDA 3/20/20)
European Commission Seeks to Delay MDR by a Year
As COVID-19 continues to disrupt Europe and pull medical device companies in different directions, the commission will propose to delay the implementation of the Medical Devices Regulation (MDR) by one year. MDR was due to apply from 26 May. (Raps 3/25/20)
European Commission Adopts Revised Standards to Speed Devices to Market
The revised standards are meant to speed the production of medical face masks, gloves, containers for intravenous injections, sterilization devices and disinfectants and alter particular requirements for emergency and transport ventilators, among others. As part of joint efforts to combat the coronavirus pandemic, the commission, CEN and CENELEC also agreed to make a number of the harmonized standards for medical protective equipment, like face masks and single-use gloves, freely available to companies that want to start producing them.
MDCG Offers “Significant Change” Guidance
On March 16th the MDCG (Medical Device Coordination Group) released a guidance on what changes to a legacy (MDD) device design and intended purpose should be considered “significant” in accordance with Article 120(3) of the MDR. Clarity on this topic is important to manufacturers as a significant change in design or intended purpose of a legacy device after the date of application of the MDR will prevent the manufacturer from continuing to place that device on the market until compliance with MDR has been established. (MDCG 3/16/20)
HHS’ final interoperability rules standardize APIs for patient health data access through apps
While the two final documents from the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) specify a number of new requirements laid out in the 21st Century Cures Act – including those to prevent information blocking and other anticompetitive behaviors among providers, health information exchanges and health IT developers – new policies outlining standardized APIs will have a particular impact on third-party health app developers. Starting January 1, 2021, Medicare Advantage, Medicaid, CHIP and plans on the federal Exchanges (that begin in 2021) will be required to support a standardized API (HL7 FHIR version 4.0.1) that allows patients to access claims and various information related to their medical encounter, such as cost or clinical information, through a third-party app of their choice. The API could also be used to integrate a health plan’s information to a patient’s EHR.
Proposed Legislation Targets a Critical Regulatory-Reimbursement Gap for Medical Devices
New Opportunities for Value That Extends Lives (NOVEL) Act, aims to provide expedited reimbursement coding and provisional coverage for medical devices that have been approved via FDA’s relatively new breakthrough device designation pathway, and modify current approval and reimbursement pathways.(MDDI 3/11/20)
Trump administration expands Medicare telehealth benefits for COVID-19 fight
Under the expansion, Medicare will temporarily pay clinicians for telehealth services nationwide to help stem the spread of the novel coronavirus. Physicians, nurse practitioners, clinical psychologists and licensed clinical social workers can now offer telehealth to Medicare beneficiaries in any healthcare facility, including a physician’s office, hospital, nursing home or rural health clinic, as well as from their homes, according to CMS. Clinicians can bill immediately for dates of service starting March 6, 2020 with telehealth services paid under the Physician Fee Schedule at the same amount as in-person services. (MobiHealthNews 3/17/20)
FCC Expands Access to Broadband Resources for Telehealth Providers
Federal officials are relaxing broadband rules to enable hospitals and health systems to work with Internet service providers to improve connectivity for telehealth and mHealth programs. The Federal Communications Commission announced changes to its Rural Health Care (RHC) and E-Rate programs that will make it easier for broadband companies to support connected health outreach. More specifically, the FCC’s Wireline Competition Bureau has waived its gift rules to give those providers the freedom to offer – and care providers to accept – improved connections and telemedicine technology during the Coronavirus (COVID-19) pandemic.
Telehealth technology expansion opportunities abound in response to pandemic
Review of China’s use of the telehealth technology in the past months can offer an example to the United States. Nontraditional med-tech companies sprang up to help triage and treat patients across the country. Telecom companies acted quickly to establish coverage of 5G internet networks to reduce the risk of exposure due to travel for patients and providers. Similar innovations are now burgeoning in the US, including access to initial screening tools to identify patients who may be showing symptoms of the virus. Reimbursement limitations may slow the rapid adaption of these technology developments in the US healthcare system, but a $500 million emergency waiver package for Medicare services should help to overcome this challenge.
(Health Affairs 3/26/20)
American Medical Association praises policy to lessen telemedicine HIPAA restrictions during COVID-19
The American Medical Association issued a statement applauding the HHS (Health and Human Services Office for Civil Rights) decision to relax restrictions on communication services that might not comply to the strict HIPAA guidelines. This means that providers are temporally able to use Skype, Facetime, or similar services for telemedicine without fear of repercussions in order to increase patient access. This “enforcement discretion” policy applies to only providers who are acting toward the “good faith provision of telehealth” during the current national healthcare emergency.
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, Mohammed Kazi, MS, Simbex Quality Systems Coordinator, and Laura Bleyendaal, MBA, Simbex Centers Fellow. A story’s inclusion does not imply endorsement by Simbex.