This document gives an overview, core objectives of the act and enumerates purpose of each part / division of the 21st Century Act. It lists down the sections of the act which have a direct impact on Healthcare IT and gives a brief overview of each section.This document also explains the impact of 21st Century Cures Act on regulatory bodies: FDA / NIH / HSS.

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19 September, 2017 | Author : Bharadwaj Tanguturi | Healthcare Business Analyst
21st Century Cures Act
and its Impact on Healthcare IT

2. 2
Objectives
 21st Century Cures Act aims to:
• Improve research and innovation where Pharma companies etc. are impacted
• Classify medical devices where medical device companies are impacted
• Hasten Drug Discovery-to-Delivery cycle where FDA, pharma companies etc. are
impacted
• Improve interoperability where hospitals, EHR vendors, HIE etc. are impacted
• Classify Healthcare software where IT consultants, HIT vendors are affected
 This document gives an overview, core objectives of the act and enumerates purpose of
each part / division of the act
 It lists down the sections of the act which have a direct impact on Healthcare IT and
gives a brief overview of each section
 This document also explains the impact of 21st Century Cures Act on regulatory bodies:
FDA / NIH / HSS

3. 3
Agenda
 The 21st Century Cures Act: Overview
 Purpose: Division A/B/C
 Sections Pertaining to HIT
 Sections Pertaining to Penalties
 Impact: On FDA/NIH/HHS
 Key Takeaways

4. 4
Overview
The 21st Century Cures Act (Cures Act), passed into
law in Dec '16, is designed to :
 Promote and fund the acceleration of research
into preventing and curing serious illnesses
 Accelerate drug and medical device
development
 Attempt to address the opioid abuse crisis
 Improve mental health service delivery
Anatomy
The law consists of 3 divisions:
 Division A : 21st Century Cures
 Division B : Helping Families with a Mental
Health Crisis
 Division C : Increasing Choice, Access, and
Quality in Health Care for Americans
The 21st Century Cures Act: Overview
Objectives of the Act
 Advance R&D through better funding medical
innovation projects
 Bring positive changes to the FDA approval
process for drugs & medical devices
 Improve interoperability, privacy, security and
data sharing
 Bring classification into HIT products
 Improve the delivery of mental health services
 Strengthen support to combat opioid abuse
 Introduce mechanisms to speed regulatory
review and bring medicines and devices to
market faster
Affected Stakeholders
 IT vendors: EHR, HIE, RIS, DB vendors
 Regulatory bodies: FDA, NIH etc.
 Medical research institutes
 Medical device companies
 Pharma companies

5. 5
Focus Area Description
 Promote innovation projects like Cancer Moonshot, NIH innovation projects
 Provide guidelines for the state response to the opioid addiction
 Promote National Institutes of Health (NIH) reauthorization and strategy plans
 Initiate Precision Medicine initiative
 Promote research through “Next Generation of Researchers” initiative
 Set privacy protection for human research subjects
 Reduce administrative burden for researchers
 Initiate patient-focused drug development
 Report on patient experience drug development
 Focus on developing lifesaving new drug therapies
 Focus on GAO studies and real world evidence drugs
 Focus on transparent reporting and open sharing of data among stakeholders
 Restrict data blockage by various entities
 Focus on leveraging electronic health records to improve patient care
 Initiate GAO study on patient matching and patient access to health information
 Strengthen the telehealth services in Medicare
Purpose: Division A
Discovery
Development
Delivery
Focuses on faster discovery, development and delivery of lifesaving drugs.

6. 6
Focus Area Description
Strengthening leadership
and accountability
 Improve the quality of behavioral health programs
 Initiate GAO study for programs on mental illness
Ensuring that mental and
substance use disorder
prevention, treatment, and
recovery programs keep pace
with science and technology
 Tackle priority mental health and substance use disorder treatment
needs of regional and national significance
 Encourage evidence-based practices for older adults
 Initiate National violent death reporting system
 Promote assisted outpatient treatment
 Provide mental and behavioral health education, and training grants
Compassionate
communication of HIPAA
 Focus on confidentiality of records
 Initiate clarification on permitted uses and disclosures of PHI
Medicaid mental health
coverage
 Initiate rule of construction for Medicaid coverage of mental health
 Establish study and report on Medicaid managed care regulation
 Provide EPSDT services to children in IMDs
 Promote electronic visit verification system
Purpose: Division B
Addresses the prevention and treatment of mental illnesses and substance abuse, treatment
coverage etc.

7. 7
Purpose: Division C
Focus Area Description
Provisions relating
to Medicare Part A
 Establish beneficiary equity in the Medicare hospital readmission program
 Update the rules on hospital length of stay in all long term stay hospitals
 Bring changes to Medicare classification for certain hospitals
Provisions relating
to Medicare Part B
 Continue Medicare payment under Hospital Outpatient Prospective Payment
System (OPPS)
 Initiate treatment of cancer hospitals in off-campus outpatient department of a
provider policy
 Allow physical therapists to utilize locum tenens arrangements under Medicare
 Initiate extension of the transition to new payment rates for durable medical
equipment
Other Medicare
provisions
 Help with enrollment data reporting for Medicare
 Preserve the Medicare beneficiary choice under Medicare Advantage
 Allow certain beneficiaries to pick a Medicare Advantage plan
 Improve the assignment of beneficiaries under MSSP
Concerns Medicare programs and federal tax laws related to health plans for small employers.

8. 8
Sections Pertaining to HIT (1/4)
Section Key Takeaways
1001 Precision Medicine Initiative (Component 3,4)
 IT systems will have data to help predict most effective treatment for a patient
 EHR can be used for safe and secure data transfer across the Precision Medicine
Initiative
 “All of us” research program:
Volunteers to donate their physical, genomic, EHR based clinical data to NIH for research
 Healthcare IT Interoperability would be used to strengthen Precision Medicine Initiative
3060 Clarifying medical software regulation
 Certain IT systems are not counted as medical devices and won’t be regulated by FDA
4001 Assisting doctors and hospitals in improving quality of care for patients
 Incentives to providers for adoption of meaningful use of certified EHR
 Use of data for value based payment programs
 Health information technology certification for medical and pediatric specialties
 Easy sharing and access of data. Focus on data privacy and security
 Reporting of clinical data for administrative purposes
While all the parts/sections to the law are concerned with U.S Healthcare, specific sections concern
about Healthcare IT. Here are the actual titles and brief descriptions of those sections of the act:

9. 9
Sections Pertaining to HIT (2/4)
Section Key Takeaways
4002 Transparent reporting on usability, security, and functionality
 No restriction on interoperability, usability, etc. for care providers, patients and physicians
 IT vendors to publish APIs and ease exchange of Health Information
 Guidelines for exchange of health Information to encourage higher interoperability
 Exemptions of an eligible hospitals from negative payment adjustments
4003 Interoperability
 Rules for certified vendors to attest claiming for interoperable software
 Develop HIE framework for greater interoperability among EHR/EMR vendors
 It supports digital contact information index
4004 Information blocking
 Penalties for provider/health information exchange engaged in information blocking
 Restrict authorized access, exchange, use of electronic health information and transition
between certified HIT by provider
4005 Leveraging electronic health records to improve patient care
 HIT developer will be working as a provider for purposes of reporting and conducting
patient safety activities
 Improving clinical care through the use of HIT that could result in improved patient safety,
health care quality, or health care outcomes

10. 10
Sections Pertaining to HIT (3/4)
Section Key Takeaways
16003 Treatment of eligible professionals in ambulatory surgical centers for meaningful use and MIPS
 Exemptions for physicians from penalties under EHR incentive programs and MIPS
 Timeline for exemptions from penalties and policies for mandatory EHR
4006 Empowering patients and improving patient access to their electronic health information
 Promote patient access to electronic health information through Health Information Exchanges
 Secure access for their updated electronic health records remotely
 Policies to facilitate patient communication with hospital information system
 Certification & development of patient centric EHR
4007 Government Accountability Office (GAO) Study on patient matching - a study on methods for
securely matching patient records to the respective patient
 Appropriate patient matching to provide secure exchange of health information
 Evaluate current methods for patient matching based on performance related to privacy, security,
improving matching rates, reducing matching errors and reducing duplications
 Define additional data elements to assist with patient matching, and set standards to EHRs to
improve patient matching

11. 11
Sections Pertaining to HIT (4/4)
Section Key Takeaways
4008 GAO (Government Accountability Office) study on patient access to health information
 Improve patient access to PHI (of self) by reducing barriers and complications
 Provide data access to the individual in the form or format requested
4009 Improving Medicare local coverage determinations
 List all Medicare administrative contractors on Medicare internet site
4010 Medicare pharmaceutical and technology ombudsman
 Review of complaints, grievances, and requests on new and life-saving technologies by
Medicare Pharmaceutical and Technology Ombudsman
4011 Medicare site-of-service price transparency
 Website which shows price transparency for outpatient hospital services
4012 Telehealth services in Medicare
 Focus on improvement in quality/efficiency through the expansion of telehealth services
 Suggest critical parameters to ace Telehealth services under Medicare programs

12. 12
Section Title Amount Description Applies to
4004 Penalties for
information
blocking
$1,000,000
(up to) per
violation
Depends on the following factors:
 Nature and extent of the information
blocking
 Harm resulting from information blocking
 The number of patients affected
 The number of providers affected
 The number of days the information
blocking persisted
Healthcare
Information
exchange
/Network
exchange/ EHR
developer
5003 Penalties for
violations of
grants,
contracts
and other
agreements
$10,000 -
$50,000 per
violation
Breakup of the penalty:
 $10,000 per specified claim
 $50,000 for each false statement/
omission/ misrepresentation of a material
fact
 $50,000 for each false record or statement
 $50,000 for each false record or statement
 $15,000/day for the failures
Research
organization/
agency
/scientist/IT
vendor
Sections Pertaining to Penalties
One of the core objectives of the law is to improve data interoperability across IT systems. One of
the way of achieving it is by penalizing data blocking etc. More details on the same are as below:

13. 13
Impact: On FDA
Focus Areas Impact
 Develop a framework for the Real World Evidence program
 Incorporate adaptive designs and statistical modeling into new drug applications
 “Limited population pathway”- expedite antimicrobial drug approvals
 Approvals to new regenerative therapies based on clinical anecdotes and surrogate
endpoints instead of clinically relevant outcomes
 Changes to high-risk (Class-III) medical device approvals by 3rd party instead of FDA
 High-risk medical devices approval based on anecdotal case studies instead of the
usual clinical trials
 Priority review process or fast track review for breakthrough devices
 Breakthrough device approvals within 60 days instead of 300 days (max)
 Reduce HDE (Humanitarian Device Exemption) patient population threshold from
4000 to 8000 patients
 Identify devices that are exempt from reporting requirements (Class-II)
 Out of FDA jurisdiction: Five categories of low-risk software and certain Clinical
Decision Support software
 Accessories shall be classified based on their intended use (and not use parent's
device's classification by default, which is the case currently)
 Exemption of mobile apps if unrelated to the diagnosis/ prevention of diseases
FDA Funding: $80 Million (over 2 years)
Drugs
Devices
Software

14. 14
Impact: On NIH
Focus Areas Impact
 Total Funding: $4.8 billion
 Timeline: Over the next 10 years, beginning in fiscal year 2017
 Breakup of Funding:
• Precision Medicine ($1.45 B)
Initiative for research into the genetic, lifestyle and environmental
variations of disease
• BRAIN Initiative ($1.5 B)
To improve the understanding of diseases like Alzheimer's
• Beau Biden Cancer Moonshot ($1.8B)
To speed up cancer research
• Regenerative medicine ($30M)
 Total Funding: $1 billion
 Timeline: Over the next 2 years, beginning in fiscal year 2017
 Implement measures to reduce the administrative burdens of researchers
 Promote "cutting-edge" research and fund "high-risk, high-reward" projects
Opioid Abuse
Prevention and
Treatment Activities
Other Activities
Big Science Initiative

15. 15
Impact: On HHS
Focus Areas Impact
 EHR Reporting Program for HIT developers to attest their product's security, user-
centered design, interoperability, and real-world functionality
 Propose rules pertaining to EHR interoperability requirements
 Maintain a list of all EHR products on its site to help users choose EHR
 Evaluate current incentive programs to spur increased technology adoption
 Clarify HIPAA privacy rules defining when family members/caregivers can receive
health information on behalf of the patient
 National Provider Digital Index to provide centralized access to all relevant
information for all providers
 Educating stakeholders on their access to electronic health information, including
through HIE, patient portals, or other third-party applications
 Establish Trusted Exchange Framework and related policies to expedite
interoperability among EHRs
HHS Funding: $15 Million (over 4 years)
EHR
Others

16. 16
Key Takeaways
Focus Areas Stakeholders Affected Impact
Penalizing
wrong-doing
EHR Vendors  Impose hefty civil penalties for information blocking / contract
violations etc.
Promoting
research
Pharma Companies  Allocate funds for advanced research, opioid addiction etc.
 Allocate resources towards mental health, including evidence -
based therapies and telehealth services under Medicare
Improvise
drug lifecycle
Pharma Companies  Update drug approval processes for certain antibiotics
 Simplify and expedites Drug approvals
 Safeguard patient privacy in research
Devices Medical Device
companies
 Expedite review process for "breakthrough" technologies
 Accelerate the approval of certain regenerative therapies
 Exemption to certain tracking and reporting software from being
classified as medical devices
Software and
Health IT
systems
Healthcare software
vendors, HIT consultants
 Classification of software and exemption to low-risk software
from FDA approval
 Expedite interoperability among EHRs and improve secure
exchange of health information

17. 17
 https://www.congress.gov/bill/114th-congress/house-bill/34/
 https://www.nihcollaboratory.org/Pages/Grand-Rounds-01-06-17.aspx
 https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmend
mentstotheFDCAct/21stCenturyCuresAct/default.htm
 https://en.wikipedia.org/wiki/21st_Century_Cures_Act
References

18. 18
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Author:
Bharadwaj Tanguturi
Healthcare Business Analyst
thoughtleaders@citiustech.com