I N S I D E T H I S
I S S U E :
21st Century Cures 1
Did You Know? 3
Midwest Division Provider Update
J A N U A R Y 2 0 1 7 V O L U M E 2 I S S U E 1
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This newsletter is intended solely as a communications modality and should not be considered to be an official publication of HHS or CMS
federal register posting of devices that
will be exempt from class I and II report-
ing requirements.
“Sensible oversight for technology which
advances regulatory efficiency” looks at
improving e-systems. This section clearly
states it purpose is to address administra-
tive, operational, laboratory, financial and
workflow systems and clearly states it is
not related to software for devices that
directly impact patient care.
It is not intended to influence treatment
recommendations but is to support clini-
cians.
The Health Information Technology must
be secure, provide full access to health
information and The Act specifically
notes “no information blocking.” Vendors
that offer systems to providers need to
ensure these requirements are met and
provider purchasers need to “rigorously”
test the system.
The CMS Administrator is to provide in-
formation regarding telemedicine. Specif-
ically, beneficiaries, including dual eligi-
bles, that could benefit from telemedicine
to manage chronic conditions.
(Continued on page 2)
Signed into law on December 13th, The Act
“to accelerate the discovery, development, and
delivery of 21st century cures, and for other
purposes” is retrievable from https://
www.congress.gov/bill/114th-congress/house-
bill/6. Although the bulk of the law targets
NIH and FDA, some of the provisions cross
programmatic lines. Some of the notable men-
tions are below.
To streamline the approval process for
some new drugs, an expedited approval is
now optional. Consideration for approval
will take into account medications de-
signed to target urgent needs, such as ill-
nesses or conditions that are severe, rare,
highly prevalent or without suitable treat-
ment alternatives.
Antibiotic stewardship to monitor use of
antibacterial and antifungal medications
and tracking of resistance, with the results
of the data to be made publically available
FDA to “ease regulatory burden” on class
I and II devices. Not sure what those are?
You can conduct a datamining expedition
at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/Overview/
ClassifyYourDevice/ucm051530.htm or
just wait a month or so for the required
P A G E 2
M I D W E S T D I V I S I O N P R O V I D E R
Also, information on the types of high volume conditions or services that can be pro-
vided through telehealth.
Somewhere under the CMS umbrella, the agency will make room for a Pharmaceutical
and Technology Ombudsman to address coding or coverage complaints or grievances
from manufacturers of meds, devices or biotechnology.
The Act also continues the fight against prescription drug abuse. Following the path led
in the Comprehensive Addiction and Recovery Act (CARA) CMS is to initiate a Pre-
scription Drug Plan to monitor and control access for individuals identified to be at risk
for drug abuse. This section of the 21st Cures also accounts for appeal rights for indi-
viduals designated as at risk and the roles and limitations of the sponsors. As men-
tioned in CARA, Hospice recipients and residents of nursing homes and ICFs are ex-
empt from being designated as at risk.
V. Vachon, CMS RO VII
P A G E 3 V O L U M E 2 I S S U E 1
S&C 17-10-CAHs dated December 1, 2016
incorporated the CAH survey procedures and
Emergency Services standard into the Ap-
pendix W’s C0207. The personnel standard
at 485.618(d)(3) included clinical nurse spe-
cialist to the list of acceptable personnel—
provided the training/experience/availability
criteria is met and the complexity and nature
of the request for care is within the scope of
practice of the treating nurse.
S&C 17-11-CLIA also dated December 1st,
contains the latest revisions to Appendix C.
The updates includes additions and deletions
of a few D tags and acceptance of the Ameri-
can Osteopathic Board of Dermatology as
equivalent to the American Board of Derma-
tology.
S&C 17-12-NH, dated December 9, 2016
places enforcement of the prohibition of
binding arbitration on hold until and unless
the current injunction is lifted.
The FDA Takes on Cybersecurity Flaws
in Medical Devices
“Medical device manufacturers and health
care facilities should take steps to ensure
appropriate safeguards. Manufacturers are
responsible for remaining vigilant about iden-
tifying risks and hazards associated with their
medical devices, including risks related to cy-
bersecurity. They are responsible for putting
appropriate mitigations in place to address
patient safety risks and ensure proper device
performance.
Hospitals and health care facilities should
evaluate their network security and protect
their hospital systems.” (FDA.gov, 2016)
http://www.fda.gov/MedicalDevices/
DigitalHealth/ucm373213.htm
Cyber Security Webinar
On December 28, 2016, the FDA published its
final report to provide guidance and instruc-
tions regarding cyber security of devices al-
ready on the market. You can review the doc-
ument at http://www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM482022.pdf and
participate in a free webinar on January 12th
beginning at 1PM EST.