June Medical Device Regulatory & Payment News

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General | Software | Rehab & AT Injury PreventionPain Management Real World Evidence (RWE) Pediatrics

Regulatory News

Cefaly in Hot Pursuit of a Migraine Prevention Indication 
Aiming for indication to treat the chronic migraine patient population. Cefaly consists of a self-adhesive electrode that is placed on the forehead and the device is magnetically connected to electrode.
(MDDI 6/1/18) Pain Management

Acceptance Growing for BrainsWay’s Depression Therapy
Three companies have been cleared for Transcranial Magnetic Stimulation (TMS) technology in the U.S this year.
(MDDI 5/7/18) Pain Management

FDA Proposes Changes to Classification Rules for Combo Products
Proposed change would be to remove existing pathway to request that FDA reconsider a product classification determination.
(RAPS 5/14/18) Pediatrics 

FDA clears MC10’s BioStamp nPoint wearable sensor
Wireless, biometric data collection platform features flexible, body-conforming rechargeable sensor patches that are reusable and can record data for up to 24 hours.
(MassDevice 5/17/18) General 

Apple opens EHR data to iOS app developers
With the new Health Records API release, developers will now be able to use that electronic health record to create apps that aid in disease management, medical research and other purposes.
(MassDevice 6/6/18) Software

EU MDR, IVDR Transition: One Year in, Lots of Guidance Still to Come
Main compliance concern: for some higher risk implants, where the device is demonstrated to be equivalent to an already marketed device, the two companies will need to have a contract in place to allow access to technical documentation on an ongoing basis.
(RAPS 5/16/18) General 

FDA launches medical device innovation challenge to combat opioid crisis
Seeking new medtech to help detect, treat and prevent addiction. Companies selected by the FDA under the new program will work closely with the agency, with accelerated development and review of their products.
(MassDevice 5/30/18) Pain Management 

Medtronic Faces Cybersecurity Risk for Clinical Programmer
Vulnerability could “allow an attacker with physical access to an 8870 N’Vision Compact Flash” card to access personal information. Findings revealed a low safety risk because physical access to a physician programmer is needed to exploit the vulnerability; this does not pose a risk for changing the function or performance of an implanted device; programmers are not commercially sold, and these devices are intended for only healthcare practitioners. 
(MDDI 5/18/18) Software

Payment News

Reimbursement down for most orthopedic subspecialties
Analysis of Medicare data for procedures performed from 2000 to 2016 showed that, except for the removal of an orthopedic implant, all ortho procedures had a decrease in reimbursement. Shoulder arthroscopy/ decompression, THR/TKR, repair of tendons/rotator cuff and repair of high/trochanteric fracture had the greatest annual decreases. Trauma procedures had the smallest decreases when compared with spine, sports, and hand.
(RyOrtho 5/25/18) Rehab & AT  

State Medicaid Programs Are Seeing the Value of Telehealth at Home
However, while remote patient monitoring (RPM) is gaining traction with the AMA and CMS, state Medicaid programs are still placing a number of restrictions to be aware of like defining what conditions can be monitored at home and limiting the devices used and information gathered.
(mHealthIntelligence 5/15/18) Software | RWE  

CMS leverages Medicaid Program to combat the Opioid crisis
CMS released guidance on 6/11 to inform state Medicaid programs on the tools available to them for treating opioid addiction. Guidance covers topics related to Neonatal Abstinence Syndrome (NAS) and goals to enhance tech that can be used for the prevention and treatment of negative opioid outcomes.
(CMS 6/11/18) Pediatrics Injury Prevention | Pain Management  

VA finalizes interstate licensing rule that will ‘open the aperture’ for telehealth
VA finalized a long-awaited rule that will allow clinicians to treat patients across state lines using telehealth.
(FierceHealthcare 5/10/18) Software

Health IT, mental health groups back bill to eliminate telehealth restrictions for opioid treatment
The bill, introduced by a bipartisan group of senators earlier this month, would waive site restrictions on Medicare reimbursement for telehealth treatment for substance abuse disorders.
(FierceHealthcare 5/30/18) Pain Management


SetPoint Brings Bioelectronic Market to the Forefront with Study
SetPoint’s device stimulates the vagus nerve with digital doses of electricity designed to activate the cholinergic anti-inflammatory reflex to produce a systemic immunorestorative effect.
(MDDI 6/11/18) Pain Management

VA signs $10B EHR contract with Cerner
To ensure interoperability with DoD, and after controversial delays, the VA has signed a Cerner EHR implementation contract to replace the homegrown VistA system.
(EHRIntelligence 5/18/18) Software 

New mHealth Technology Platform Aims to Validate Remote Monitoring
Showing more movement toward telehealth and mHealth acceptability, the OpenMedReady is framework being developed by Qualcomm Life, Philips and several other mHealth vendors aims to improve validation of patient identity and consent and data integrity for remote patient monitoring programs. Patient identity, consent, and data integrity have been concerns in the past for healthcare professionals when implementing these technologies.
(mHealthIntelligence 5/3/18) Software | RWE

3M sticks it to non-sticky medical tape
Single-coated tape is water resistant, offers improved stretchiness and air penetration, and can be worn for up to 14 days. It combines adhesive with a white meltblown elastic nonwoven backing on a silicone release liner. It is compatible with ethylene oxide sterilization, electron beams and gamma sterilization.
(MassDevice 6/12/18) Injury Prevention 

Gates Foundation looks to develop simple, single-use injection device for global use
Foundation is taking requests for proposals to develop a dual-chamber, prefilled, single-dose injection device for use in remote in-home settings by low skilled healthcare workers and through self-administration.
(MassDevice 5/24/18) Pediatrics 

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, Simbex Research Engineer and Cassie Brugger, MA, Simbex Centers Senior Program Administrator.  A story’s inclusion does not imply endorsement by Simbex, LLC.

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