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INSIDE THIS ISSUE: 21st Century Cures 1 Did You Know? 3 Midwest Division Provider Update JANUARY 2017 VOLUME 2 ISSUE 1 CONTACT US: For suggesons or submissions, contact [email protected] This newsleer is intended solely as a communicaons modality and should not be considered to be an official publicaon 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 efficiencylooks 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 rigorouslytest 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 13 th , The Act to accelerate the discovery, development, and delivery of 21 st century cures, and for other purposesis 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 burdenon 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
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Midwest Division Provider Updateweb.mhanet.com/Regulatory/January 2017.pdf · 2017-01-09 · INSIDE THIS ISSUE: 21st Century Cures 1 Did You Know? 3 Midwest Division Provider Update

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Page 1: Midwest Division Provider Updateweb.mhanet.com/Regulatory/January 2017.pdf · 2017-01-09 · INSIDE THIS ISSUE: 21st Century Cures 1 Did You Know? 3 Midwest Division Provider Update

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

CONTACT US:

For suggestions or submissions, contact

[email protected]

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

Page 2: Midwest Division Provider Updateweb.mhanet.com/Regulatory/January 2017.pdf · 2017-01-09 · INSIDE THIS ISSUE: 21st Century Cures 1 Did You Know? 3 Midwest Division Provider Update

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

Page 3: Midwest Division Provider Updateweb.mhanet.com/Regulatory/January 2017.pdf · 2017-01-09 · INSIDE THIS ISSUE: 21st Century Cures 1 Did You Know? 3 Midwest Division Provider Update

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.