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Regulatory News

Medical Devices; Immunology and Microbiology Devices; Classification of the Brain Trauma Assessment Test
New Classification: For brain trauma assessment tests, the special controls require developers to use at least one unmodified clinical specimen with the brain injury biomarker for performance testing as well as labeling statements indicating that the test is meant to be used in conjunction with other clinical information.
(Federal Register 6/14/18) Injury Prevention

Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling-Questions and Answers
FDA issues guidance to inform industry on how to communicate information about products in a manner consistent with FDA-required labeling.
(FDA 6/18/18) General 

6-Month Delay of Common Rule Changes Explained
HHS announced a six-month delay to the federal policy on the protection of human subjects (a.k.a the “Common Rule”) until 01/21/19. Institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions of the 2018 Requirements during the delay period.
(RAPS 6/18/18) General 

White House proposes 30% cut to FDA headcount, reorganization
Proposal would cut $1.3 billion in resources from the agency and 5,000 members of its staff and leave the agency to oversee only drugs, devices, biologics, tobacco, dietary supplements and cosmetics, according to the report. The agency would also adopt a new moniker: the Federal Drug Administration. The goal of the federal reorganization is meant to make government agencies “more efficient, effective, and accountable.”
(MassDevice 6/22/18) General 

Pre-Cert Pilot: FDA Updates on Framework, Asks for Input
Update provides additional details on how FDA might leverage the IMDRF risk categorization framework “to enable precertified companies to determine the premarket review pathway for their products.”
(FDA) Software

House passes sweeping opioid measure
Encouraging nonopioid treatments was among the changes included in the act and it would direct the FDA to update guidance on existing pathways to bring novel nonaddictive treatments for pain and addiction to patients.
(FierceHealthcare 6/22/18) Pain Management 

ANSI UL Medical Device Cybersecurity Standard Receives Official US FDA Recognition
FDA has officially recognized a new consensus standard, ANSI UL 2900-2-1, for assessing network-connected medical device cybersecurity risk. FDA recognized a related standard, UL 2900-1 Ed. 2017, last year.
(Emergo 6/26/18) Software

Cybersecurity: Are You Prepared?
The medical/healthcare industry last year accounted for more than 23 percent of total breaches in 2017, resulting in the “exposure of more than five million patient records,” as reported by Merlin International and the Ponemon Institute with a survey of more 600 executives.
(MDDI 6/29/18) Software


Payment News

House Bill Would Streamline CMS’s Process for Breakthrough Technologies
AdvaMed has issued a statement in support of the bipartisan legislation introduced that would streamline access and coverage to breakthrough technologies for serious illness.
(AdvaMed 6/5/2018) General 

CMS Proposes Changes to the Medicare Physician Fee Schedule and Quality Payment Program
CMS suggests that proposed changes will increase the amount of time care providers can spend with their patients and reduce the burden of paper work, particularly for evaluation and management payment. The proposed changes would also pay clinicians for virtual check-ins, evaluation of patient-submitted photos, and expand Medicare-covered telehealth services to include prolonged prevented services.
(Centers for Medicare & Medicaid Services 7/12/2018) General Software

FierceHealthcare reports that the CMS proposed rule forges way for telehealth payments
With the ability to provide virtual check-ins and review patient photos or videos using asynchronous or “store-and-forward” transmission, the CMS proposed rule is seen as a significant first step in overcoming telehealth payment obstacles.
(FierceHealthcare 7/16/2018) General Software

More trending in Telehealth:

New CMS Proposals to Modernize and Drive Innovation in Durable Medical Equipment
CMS attempts to simplify Medicare’s DMEPOS Competitive Bidding Program to drive competition and increase affordability in new proposals announced this month. The announcement also included a solicitation of stakeholder feedback on CMS’ approach for establishing DME fee schedule amounts.
(Centers for Medicare & Medicaid Services 7/11/2018) Rehab & AT

House bill to expand health savings accounts
A roster of bills designed to increase health savings account (HSA) contribution limits and expand the number of people who qualify to use them.
(Investment News 7/16/2018) General

AHA ‘strongly opposes’ interoperability as a Medicare requirement
American Hospital Association said it “strongly opposes” revising Medicare Conditions of Participation to include interoperability requirements. The hospital association argued that interoperability is difficult for surveyors to measure and unfairly targets hospitals for data sharing problems that span the healthcare ecosystem.
(FierceHealthcare 6/25/18) General RWE

Medtronic launches outcomes-based reimbursement program
Medtronic’s ‘Performance Guarantee Program’ will dole out flat-fee reimbursements of up to $25,000 per pump over four years for diabetes-related inpatient hospitalization and ER admissions.
(MassDevice 6/28/18) General

CMS delays participation deadline for new bundled payment program
Providers have a little more time to decide whether to participate in the Trump administration’s new bundled payment program. CMS has pushed back the deadline for submitting participation agreements and clinical episode selections to Aug. 8, a one-week extension. The voluntary program was announced in January after the administration ended two mandatory bundled payment models.
(Centers for Medicare & Medicaid Services) General


MarketWatch

Noble launches AdhereIT platform for self-injection training
Connected device platform, AdhereIT, provides people that use auto-injectors with real-time feedback regarding their injection. The platform can detect when the auto-injector makes contact with a user’s skin and the time when an injection starts and ends.
(Drug Delivery Business 6/13/18) General

HealthPrize takes aim at medication nonadherence with habit-forming tech
HealthPrize’s solution employs tools like weekly quizzes and surveys that encourage users to engage and compete with one another. The company’s average user logs into the platform nearly five times per week and spends 38 minutes each month using the system.
(MassDevice 6/15/18) Software

Fresca Medical wins de novo nod from FDA for Curve sleep apnea device
Fresca Medical won FDA de novo approval for its Curve positive airway pressure delivery system designed to treat obstructive sleep apnea (OSA). The system features the company’s SmartValve technology which it claims allows the system to treat OSA with less airflow than conventional CPAP systems. Indications for Use: intended to treat OSA by delivering a therapeutic breathing pressure to a patient. It provides positive airway pressure during expiration and also during an incipient apnea.
(MassDevice 6/25/18) Injury Prevention

Kent Imaging inks wound care imaging deal with SerenaGroup
Wound healing research firm SerenaGroup will adopt use of Kent’s KD203 near infrared imaging technology designed for measuring oxygenation, which Kent Imaging touted as the “best biomarker” of tissue healing.
(MassDevice 6/27/18) Injury Prevention

ReWalk Robotics expands ReStore soft exo-suit trial
Company expects to launch its ReStore device for stroke patients in Europe and the U.S. in the first half of 2019. The exo-suit is designed as a gait therapy solution, providing coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle.
(MassDevice 6/28/18) Rehab & AT

Japan approves Inspire Medical’s obstructive sleep apnea neurostim device
The Inspire system is a closed-loop, pacemaker-like system designed to stimulate nerves to keep airways open during sleep to treat obstructive sleep apnea.
(MassDevice 6/29/18) Injury Prevention

ResMed, Google’s Verily ink sleep-apnea-focused joint venture deal
ResMed and Verily inked a new joint venture deal aiming to develop software solutions to improve diagnosis, treatment and care for sleep apnea and other breathing related sleep disorders. Joint venture will use sleep apnea knowledge from ResMed and Verily’s data analytics technologies.
(MassDevice 7/11/18) Injury Prevention

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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