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Regulatory News

CDRH Offers Look at Upcoming Guidance Documents in FY 2019
Notable guidances to look out for: “Content of Premarket Submissions for Cybersecurity of Medical Devices of Moderate and Major Level of Concern”, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device PMAs, De Novos, and HDEs”, “Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria”, and “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act”
(RAPS 10/3/18) General | Software

CDRH Works to Develop Proposed De Novo Regulation
The regulatory review pathway for novel devices will receive major policy clarifications by mid-2019. The agency will codify the review process and identify required content for de novo classification requests in response to the anticipated program growth. There are no de novo-specific regulations at this time, which makes the de novo program somewhat of a disadvantage compared to 510(k)s and PMAs.
(RAPS 10/9/18) General

Report: Medtronic shuts down pacer programmer updates on hacking risk
Medtronic has disabled internet updates for approximately 34,000 CareLink devices designed for accessing and programming implanted pacemakers due to cybersecurity vulnerabilities with the systems.
(MassDevice 10/11/18) Software

Cybersecurity: CDRH to Update 2014 Premarket Policies
Introduces coordinated vulnerability disclosures (CVD), which provides factors to consider in developing internet-based portals to receive vulnerability reports. Adoption of CVD policies and these online portals will enable a communication bridge where patchability and updatability can be consistently documented. This will also allow for greater efficiency, timeliness and predictability in more proactive responses to vulnerabilities.
(RAPS 10/10/18) Software

Cybersecurity: FDA Spells Out Updated Premarket Policies
In the new guidance, a device would fall under Tier 1 “Higher Cybersecurity Risk” if it is “capable of connecting (e.g. wirelessly) to another medical or non-medical product or to a network, or to the internet” and a cybersecurity incident “could directly result in patient harm to multiple patients.” Examples include implantable cardiac defibrillators and pacemakers. All other devices would fall under Tier 2 “Standard Cybersecurity Risk.” The tiers are for this cybersecurity guidance only.
(RAPS 10/17/18) Software

First Version of NEST to Launch in 2019
Version 1.0 of the envisioned network of data collaborators for the advancement of real-world evidence (RWE) generation—NEST— is set to launch before the end of 2019. In addition to serving as an RWE aid in premarket regulatory decision-making, other potential measures of success relate to applicability in a broad range of devices and whether RWE-based questions can be answered. NESTcc should at least be able to answer questions around clinical evaluations and payer reimbursement decisions by next year.
(RAPS 10/24/18) RWE


Payment News

CMS Accelerates Innovation and Promotes Patient Access to Medical Technology
CMS claims that reform to the Medicare Local Coverage Determination (LCD) process will increase transparency and patient engagement in order to ensure Medicare beneficiaries access to the latest therapies and devices. Changes include requiring a consistent, standardized summary of the clinical evidence supporting LCD decisions and ensuring that Contractor Advisory Committee meetings are open to the public.
(CMS.gov 10/03/18) General 

Physical Therapy, Chiropractic Back Care Cut Opioid Use, Costs
In a new study published in JAMA Network Open, researchers from Johns Hopkins, HHS, and NIH explained that payers could improve outcomes, increase cost-effectiveness, and reduce opioid use for lower back pain by expanding non-pharmacological coverage such as physical therapy and chiropractic care.
(HealthPayer Intelligence 10/23/18) Rehab & AT Pain Management

Private Insurance Spending Has Outpaced Public Spending Since 2016
According to a new report, national insurance enrollment has plateaued since 2016 and private insurance spending has grown faster than Medicare and Medicaid spending.
(HealthPayer Intelligence 10/08/18) General 

CMS Announces Participants in New Value-Based Bundled Payment Model
The model runs from October 1, 2018 through December 31, 2023 and builds on the Bundled Payments for Care Improvement (BPCI) Initiative which ended on September 30, 2018. The new model includes 832 Acute Care Hospitals and 715 Physician Group Practices located in 49 states plus D.C. and Puerto Rico. The model will initially include 32 bundled clinical episodes in areas such as major joint replacement of the lower extremity, congestive heart failure, and sepsis.
(CMS.gov 10/09/18) General 

U.S. Department of Justice will allow CVS Health acquisition of Aetna to proceed
CVS announced earlier this month that the U.S. DOJ will allow its proposed acquisition of Aetna to proceed.
(Aetna.com 10/10/18) General 

Congress Mulls Expanding Telehealth to Help Veterans With PTSD
The Enhancing Veterans Experience with Telehealth Services (eVETS) Act was introduced in early October to expand access to telehealth and telemedicine for veterans dealing with mental health issues.
(mHealth Intelligence 10/08/18) Software

What Can Medtech Do with Medicare Data via Blue Button 2.0?
CMS went live with Blue Button 2.0, an API that gives developers access to four years of Medicare Part A, B, and D data for 53 million beneficiaries. Patient data includes the type of Medicare coverage, drug prescriptions, primary care treatment, and cost. Although it’s not as detailed as a medical device manufacturer would like, it’s worth experimenting with. Access to prescription history and other healthcare information could potentially drive decision support, provide tighter integration with other devices and systems, and/or enhance patient care.
(MDDI 9/26/18) RWE

Medical Device Makers Shut Out Of Value-Based Care Without Kickback Rule Change
AdvaMed cites federal rules that are preventing device makers from entering into certain value-based partnerships and claim that the rules will not allow the provision of any incentives unless they fall within safe harbor or a waiver.
(Forbes 10/26/18) General 


MarketWatch

Jawbone to pivot into remote patient health monitoring
The newly formed Jawbone Health will offer a subscription system to help users monitor their health and catch problems early on. The company will offer a wearable device to paying subscribers, but said that it will be “device and sensor agnostic.” Jawbone Health said that it will partner with other “clinical-grade” device makers for its system, which will be able to accept data from devices (i.e. Apple).
(MassDevice 9/28/18) Injury Prevention

mHealth Finds the Right Note For Music in Digital Therapeutics Programs
MedRhythms’ first product is MedRhythms Stride, a digital health platform for stroke rehabilitation that focuses on Rhythmic Auditory Simulation (RAS). mHealth sensors attached to a patient’s feet gather gait parameters, which are then analyzed by a smartphone app that pairs the patient’s gait with music. MedRhythms Stride is currently in trials and will soon be seeking U.S. Food and Drug Administration review, and a second product, MedRhythms Step, is being developed for fall prevention and aging in place programs for seniors.
(mHealthIntelligence 10/10/18) Rehab & AT

Next-gen Amazon Alexa could detect illness, provide medicine suggestions
The company recently patented a new version of Alexa designed to analyze speech and identify signs of illness. An example of use includes Alexa offering cough drops, alongside chicken soup, to a user who is coughing and sniffling while using the device. The patent also includes a method of tracking emotional state, and could be used for targeted advertisements based on moods.
(MassDevice 10/12/18) Injury Prevention

Zimmer Biomet launches clinical trial with Apple Watch
Using the orthopedic giant’s MyMobility app and the Apple Watch, the study aims to evaluate the app’s utility in improving outcomes and lowering costs. The study will incorporate patient feedback and continuous health and activity data from the Apple device.
(MassDevice 10/15/18) Injury Prevention

Gauss Uses AI to Accurately Measure Blood Loss
Gauss Surgical is using machine learning and artificial intelligence for the early recognition of postpartum hemorrhage. Company has developed Triton (FDA granted), a computer vision-based platform that is able to photographically quantify the blood loss in the operating room that helps physicians and clinicians accurately estimate blood loss in real-time.
(MDDI 10/17/18) 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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