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23
Department of Justice
memo emphasizes
individual
accountability in
corporate wrongdoing
Tricia R. Owsley
27
First 60-day rule
enforcement cases
unfavorable
to healthcare
providers
Colin P. McCarthy
37
SEC
enforcement
actions against
CCOs: Outlier
or new trend?
Tom Fox
32
Quality of care CIAs:
The importance of
credentialing and privileging
Chris Anusbigian, Heather Hagan,
Peter A. Khoury, and
Janemarie Schultz
a publication of the health care compliance association www.hcca-info.org
ComplianceTODAY November 2015
Social media savvy—
Think before you tweet!
an interview with Anne Van Dusen
Manager of Regulatory Compliance and Risk Management
ACM Medical Laboratory
See page  16
Social media savvy—
Think before you tweet!
an interview with Anne Van Dusen
Manager of Regulatory Compliance and Risk Management
ACM Medical Laboratory
See page  16
This article, published in Compliance Today, appears here with permission from the Health Care Compliance Association. Call HCCA at 888-580-8373 with reprint requests.
32   www.hcca-info.org  888-580-8373
ComplianceToday  November2015 FEATURE
H
igh standards of quality care are
crucial to help ensure that patients
are not neglected, healthcare orga­
nizations are not cheating federal healthcare
programs, and that patients are treated with
dignity and respect. Quality care tends to focus
not only on clinical outcomes, but on patient
satisfaction and processes of care as well. The
medical staff credentialing process typically
contributes to a healthcare provider’s efforts
to provide this high quality care and supports
patient safety efforts. The Office of Inspector
General (OIG) of the Department of Health and
Human Services (DHHS) in their 2014 and 2015
Work Plans outline ongoing reviews for the
verification of credentials before privileges are
granted.1
Verification is an important exercise
for compliance professionals to be aware of,
participate in, and support. This article focuses
on the intersection
of credentialing and
quality of care, the
medical staff cre­
dentialing process,
examples of creden­
tialing failures, and
strategies to help
improve credential­
ing processes and
controls for health­
care organizations.
What is provider
credentialing?
Medical staff cre­
dentialing is the
process of gathering
and performing primary source verification
(PSV) of information regarding physicians’
and other licensed practitioners’ qualifications.
Credentialing is a critical step to attain privi­
lege and approval by a governing board for
appointment to a medical staff. All third-party
payers require credentialing in order to become
a member of a panel or a participating provider.
by Chris Anusbigian, MBA; Heather Hagan, CIA, CRMA; Peter A. Khoury, MHA, MJ, CHC, CHPC;
and Janemarie Schultz, MBA
Quality of care CIAs:
The importance of
credentialing and privileging
»» Credentialing is a process that includes gathering and performing primary source verification.
»» False Claims Act actions can be brought in credentialing failure cases, with consequences.
»» Two government databases should be used in the credentialing process.
»» Policies and procedures for the process of credentialing should be documented and followed.
»» Compliance professionals should be engaged early in the credentialing process.
Chris Anusbigian (canusbigian@deloitte.com) is a Deloitte Advisory specialist leader
in Deloitte  Touch LLP’s Detroit office. Heather Hagan (hhagan@deloitte.com)
is a Deloitte Advisory senior manager and Peter A. Khoury (pkhoury@deloitte.com)
is a Deloitte Advisory consultant in Deloitte  Touch LLP’s Philadelphia office.
Janemarie Schultz (jschultz@deloitte.com) is a specialist master in Deloitte
Consulting LLP’s Parsippany, NJ office.
Schultz
Anusbigian Hagan
Khoury
888-580-8373  www.hcca-info.org  33
ComplianceToday  November2015
FEATURE
PSV is the act of obtaining the applicant’s
credentials (i.e., the documentation itself or
verification of the documentation) directly
from the original or primary source. Elements
of the process include review of active state
licensure, board certifications, prior practice
history, and peer recommendations. Other
databases should be checked, such as the
National Practitioners Data Bank (NPDB),
which is an electronic
information repository
created by Congress that
contains information
on medical malpractice
payments and certain
adverse actions related to
health care practitioners,
entities, providers, and
suppliers. The OIG’s List
of Excluded Individuals
and Entities (LEIE),
should also be used
in the credentialing process. This review is
necessary in the process because the Social
Security Act provides grounds for mandatory
exclusion for activities such as patient abuse,
and the less severe permissive exclusion,
which may be handed down for activities such
as not paying back a federal student loan.2
Once PSV is completed, medical staff
privileging can be performed to determine
those specific services and procedures that
the provider is deemed, by the medical staff
leadership, qualified to provide or perform.
Credentialing cannot be economic, which is
defined by the American Hospital Association
as “the use of economic criteria unrelated to
quality of care for professional competence
in determining a physician’s qualification for
initial or continuing hospital medical staff
membership or privileges.”3
An example of
economic credentialing may be limiting proce­
dures a physician can perform at an institution
because he/she has admitting privileges at a
competing hospital. Furthermore, the process
of credentialing has become so complex that
many organizations may have a full time
resource dedicated to these responsibilities.
Credentialing  quality of care
are compliance issues
Increasing scrutiny and legal action has been
focused on an organization’s legal duty to
de­ter­mine the compe­
tency of a provider, both
in qualifications and
proficiency. Not follow­
ing a rigorous process
around credentialing
and privileging can leave
the organization vulner­
able to legal action for
not meeting the estab­
lished criteria set forth
by governing bodies.
The Medicare Conditions
of Participation4
include the following require­
ments for hospitals:
·· The hospital must have an organized
medical staff that operates under bylaws
approved by the governing body and is
responsible for the quality of medical care
provided to patients by the hospital.
·· The bylaws must include criteria for
determining the privileges to be granted
to individual practitioners and a procedure
for applying the criteria to individuals
requesting privileges.
·· The medical staff must examine the
credentials of all eligible candidates for
medical staff membership and make
recommendations to the governing body
on the appointment of these candidates
in accordance with State law, including
scope-of-practice laws, and the medical
staff bylaws, rules, and regulations.
A candidate who has been recommended
by the medical staff and who has been
Increasing scrutiny
and legal action has
been focused on an
organization’s legal
duty to de­ter­mine
the competency
of a provider…
34   www.hcca-info.org  888-580-8373
ComplianceToday  November2015 FEATURE
appointed by the governing body is
subject to all medical staff bylaws, rules,
and regulations, in addition to the
requirements contained in this section.
Organizations can be held liable for cre­
dentialing failures when a provider has been
granted privileges to provide a service without
proper verification of credentials and experience.
Some organizations have been found to have:
·· Arbitrary granting of privileges that
includes “grandfathering” individuals to
provide a service when they do not meet
the current criteria;
·· Careless and disorganized collection of
initial data necessary to verify training,
board certifications, and previous
experience; and
·· Lack of policies and procedures for
ongoing verification of practitioner
qualifications, which can include
malpractice history and open cases.
Examples of credentialing failures
Specifically related to provider credentialing,
in 2003 a healthcare company entered into a
multi-million dollar False Claims Act (FCA)
settlement with the OIG. A hospital was dis­
covered to have had inadequate peer review
and credentialing procedures for cardiologists
who provided medically unnecessary services.5
This settlement led to the divestiture of the hos­
pital and was a strong statement by the OIG that
they will likely exercise their exclusion authority
when quality controls are not adequate.
The OIG has outlined what they determine
to be reportable events for organizations under
a Corporate Integrity Agreement (CIA). One of
these events is the employment of, or contract­
ing with, an ineligible person.6
For healthcare
organizations, this can present a risk that may
result in stiff penalties if unnoticed for some
time. It is imperative that healthcare organiza­
tions have effective compliance programs that
incorporate frequent review to help mitigate
this risk. Additionally, the Federal Sentencing
Guidelines go so far as to reduce penalties for
organizations that have instituted and main­
tained an effective compliance program.7
Strategies to help improve
credentialing processes and controls
Compliance professionals can employ a
number of strategies that are likely to
help reduce the risk of finding themselves
negotiating a quality-of-care CIA for
credentialing failures:
·· Verify that the Credentialing department
has a well-publicized set of policies and
procedures to outline the credentialing
process, and confirm how it meets the
requirements as defined in the bylaws of
the organization;
·· Provide assistance to the medical staff
leadership and the Quality department
in educating providers on quality
expectations, and provide them with
regular feedback with respect to their
individual contributions to quality of care;
·· Carefully scrutinize the “grandfathering”
of privileges for a service or procedure;
·· Assist in collecting data, utilizing an
organized and priority-driven system that
identifies the data necessary to meet local
and national regulatory requirements;
·· Verify that the Credentialing department
obtains and reviews documentation with
a well-structured approach;
·· Verify that the Credentialing department
documents and stores primary documents
and subsequent findings, which provides
transparency and accessibility, and also
demonstrates due diligence;
·· Confirm that the hospital bylaws
describing the credentialing process are
followed, including conducting searches
of two available databases: the NPDB and
the OIG’s LEIE;
888-580-8373  www.hcca-info.org  35
ComplianceToday  November2015
FEATURE
·· Review and monitor these
databases routinely to screen
for issues with staff members;
·· Confirm that the Credentialing
department is performing
ongoing monitoring and reviews
of provider credentials to help
validate that providers have the
ability to provide services and
procedures for which privileges
have been granted;
·· Document efforts to help
reduce these risks and increase
quality of care, and present this
information when negotiating a
quality-of-care CIA.
The compliance officer should help the
board of directors understand the important
role they often play in thoroughly reviewing
candidates for appointment to the medical
staff and also that they are not economi­
cally credentialing providers. Moreover, the
compliance officer should be a partner in
the credentialing and privileging process
and should educate board members on their
fiduciary duty with respect to their decision-
making authority during credentialing and
privileging procedures.
The Credentialing department is often
responsible for policies and procedures to
help confirm that all providers are tracked,
credentialed, and re-credentialed, but the
Compliance department can also provide
an independent assessment of the process
to confirm that controls are in place and
operating effectively. One way to do this is
to take a sample of credentialing files and
compare each file to the required documen­
tation to confirm that the credentialing file
is complete, re-credentialing has been con­
ducted efficiently, and the required reviews
and approvals have been obtained and
documented. The Compliance department
can also confirm whether all providers in
the system are known and included in the
credentialing process, and that the credentialing
database is complete.
Final thoughts
Seeing that the OIG may view lack of proper
credentialing as an actionable administrative
and governance failure, healthcare entities
should be cognizant of their current and
future practices in this regard. OIG continues
to monitor these efforts as outlined in their
2015 Work Plan. Healthcare entities should
also accept that quality of care is considered
a compliance issue, as demonstrated by
recent FCA actions. Compliance professionals
should take proactive steps to help mitigate
potential quality-of-care and patient risks in
a manner that incorporates broad stakeholder
participation, strong controls, and clearly
outlined processes.
This publication contains general information only and
Deloitte is not, by means of this publication, rendering
accounting, business, financial, investment, legal, tax,
or other professional advice or services. This publication is
not a substitute for such professional advice or services,
nor should it be used as a basis for any decision or action
that may affect your business. Before making any decision
or taking any action that may affect your business, you
should consult a qualified professional advisor. Deloitte
shall not be responsible for any loss sustained by any
person who relies on this publication.
1.	Department of Health and Human Services: 2014 OIG Work Plan, pg 7;
2015 OIG Work Plan, pg 20. Available at http://1.usa.gov/1LiEfk6
2.	Social Security Act, 42. U.S.C. §1128, available at http://1.usa.gov/1LsbIMo
and §1156, available at http://1.usa.gov/1GFMd4P
3.	American Medical Association: Policy H-230.975 Economic Credentialing.
Available at http://bit.ly/1R8WXhA
4.	42 CFR 482.22 - Condition of participation: Medical staff. Available at
http://1.usa.gov/1NamzKo
5.	Office of Inspector General: Divestiture Agreement. Available at
http://1.usa.gov/1VPMmyW
6.	Office of Inspector General: Corporate Integrity Agreement
Frequently Asked Questions - List of Reportable Events. Available at
http://1.usa.gov/17AqQ6m
7.	United States Sentencing Commission: Federal Sentencing Guidelines,
Chapter 8, §8C2.5(f). Available at http://bit.ly/1hCjXtl

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Compliance Today Article November 2015 Schultz

  • 1. 23 Department of Justice memo emphasizes individual accountability in corporate wrongdoing Tricia R. Owsley 27 First 60-day rule enforcement cases unfavorable to healthcare providers Colin P. McCarthy 37 SEC enforcement actions against CCOs: Outlier or new trend? Tom Fox 32 Quality of care CIAs: The importance of credentialing and privileging Chris Anusbigian, Heather Hagan, Peter A. Khoury, and Janemarie Schultz a publication of the health care compliance association www.hcca-info.org ComplianceTODAY November 2015 Social media savvy— Think before you tweet! an interview with Anne Van Dusen Manager of Regulatory Compliance and Risk Management ACM Medical Laboratory See page  16 Social media savvy— Think before you tweet! an interview with Anne Van Dusen Manager of Regulatory Compliance and Risk Management ACM Medical Laboratory See page  16 This article, published in Compliance Today, appears here with permission from the Health Care Compliance Association. Call HCCA at 888-580-8373 with reprint requests.
  • 2. 32   www.hcca-info.org  888-580-8373 ComplianceToday  November2015 FEATURE H igh standards of quality care are crucial to help ensure that patients are not neglected, healthcare orga­ nizations are not cheating federal healthcare programs, and that patients are treated with dignity and respect. Quality care tends to focus not only on clinical outcomes, but on patient satisfaction and processes of care as well. The medical staff credentialing process typically contributes to a healthcare provider’s efforts to provide this high quality care and supports patient safety efforts. The Office of Inspector General (OIG) of the Department of Health and Human Services (DHHS) in their 2014 and 2015 Work Plans outline ongoing reviews for the verification of credentials before privileges are granted.1 Verification is an important exercise for compliance professionals to be aware of, participate in, and support. This article focuses on the intersection of credentialing and quality of care, the medical staff cre­ dentialing process, examples of creden­ tialing failures, and strategies to help improve credential­ ing processes and controls for health­ care organizations. What is provider credentialing? Medical staff cre­ dentialing is the process of gathering and performing primary source verification (PSV) of information regarding physicians’ and other licensed practitioners’ qualifications. Credentialing is a critical step to attain privi­ lege and approval by a governing board for appointment to a medical staff. All third-party payers require credentialing in order to become a member of a panel or a participating provider. by Chris Anusbigian, MBA; Heather Hagan, CIA, CRMA; Peter A. Khoury, MHA, MJ, CHC, CHPC; and Janemarie Schultz, MBA Quality of care CIAs: The importance of credentialing and privileging »» Credentialing is a process that includes gathering and performing primary source verification. »» False Claims Act actions can be brought in credentialing failure cases, with consequences. »» Two government databases should be used in the credentialing process. »» Policies and procedures for the process of credentialing should be documented and followed. »» Compliance professionals should be engaged early in the credentialing process. Chris Anusbigian (canusbigian@deloitte.com) is a Deloitte Advisory specialist leader in Deloitte Touch LLP’s Detroit office. Heather Hagan (hhagan@deloitte.com) is a Deloitte Advisory senior manager and Peter A. Khoury (pkhoury@deloitte.com) is a Deloitte Advisory consultant in Deloitte Touch LLP’s Philadelphia office. Janemarie Schultz (jschultz@deloitte.com) is a specialist master in Deloitte Consulting LLP’s Parsippany, NJ office. Schultz Anusbigian Hagan Khoury
  • 3. 888-580-8373  www.hcca-info.org  33 ComplianceToday  November2015 FEATURE PSV is the act of obtaining the applicant’s credentials (i.e., the documentation itself or verification of the documentation) directly from the original or primary source. Elements of the process include review of active state licensure, board certifications, prior practice history, and peer recommendations. Other databases should be checked, such as the National Practitioners Data Bank (NPDB), which is an electronic information repository created by Congress that contains information on medical malpractice payments and certain adverse actions related to health care practitioners, entities, providers, and suppliers. The OIG’s List of Excluded Individuals and Entities (LEIE), should also be used in the credentialing process. This review is necessary in the process because the Social Security Act provides grounds for mandatory exclusion for activities such as patient abuse, and the less severe permissive exclusion, which may be handed down for activities such as not paying back a federal student loan.2 Once PSV is completed, medical staff privileging can be performed to determine those specific services and procedures that the provider is deemed, by the medical staff leadership, qualified to provide or perform. Credentialing cannot be economic, which is defined by the American Hospital Association as “the use of economic criteria unrelated to quality of care for professional competence in determining a physician’s qualification for initial or continuing hospital medical staff membership or privileges.”3 An example of economic credentialing may be limiting proce­ dures a physician can perform at an institution because he/she has admitting privileges at a competing hospital. Furthermore, the process of credentialing has become so complex that many organizations may have a full time resource dedicated to these responsibilities. Credentialing quality of care are compliance issues Increasing scrutiny and legal action has been focused on an organization’s legal duty to de­ter­mine the compe­ tency of a provider, both in qualifications and proficiency. Not follow­ ing a rigorous process around credentialing and privileging can leave the organization vulner­ able to legal action for not meeting the estab­ lished criteria set forth by governing bodies. The Medicare Conditions of Participation4 include the following require­ ments for hospitals: ·· The hospital must have an organized medical staff that operates under bylaws approved by the governing body and is responsible for the quality of medical care provided to patients by the hospital. ·· The bylaws must include criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges. ·· The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of these candidates in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations. A candidate who has been recommended by the medical staff and who has been Increasing scrutiny and legal action has been focused on an organization’s legal duty to de­ter­mine the competency of a provider…
  • 4. 34   www.hcca-info.org  888-580-8373 ComplianceToday  November2015 FEATURE appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section. Organizations can be held liable for cre­ dentialing failures when a provider has been granted privileges to provide a service without proper verification of credentials and experience. Some organizations have been found to have: ·· Arbitrary granting of privileges that includes “grandfathering” individuals to provide a service when they do not meet the current criteria; ·· Careless and disorganized collection of initial data necessary to verify training, board certifications, and previous experience; and ·· Lack of policies and procedures for ongoing verification of practitioner qualifications, which can include malpractice history and open cases. Examples of credentialing failures Specifically related to provider credentialing, in 2003 a healthcare company entered into a multi-million dollar False Claims Act (FCA) settlement with the OIG. A hospital was dis­ covered to have had inadequate peer review and credentialing procedures for cardiologists who provided medically unnecessary services.5 This settlement led to the divestiture of the hos­ pital and was a strong statement by the OIG that they will likely exercise their exclusion authority when quality controls are not adequate. The OIG has outlined what they determine to be reportable events for organizations under a Corporate Integrity Agreement (CIA). One of these events is the employment of, or contract­ ing with, an ineligible person.6 For healthcare organizations, this can present a risk that may result in stiff penalties if unnoticed for some time. It is imperative that healthcare organiza­ tions have effective compliance programs that incorporate frequent review to help mitigate this risk. Additionally, the Federal Sentencing Guidelines go so far as to reduce penalties for organizations that have instituted and main­ tained an effective compliance program.7 Strategies to help improve credentialing processes and controls Compliance professionals can employ a number of strategies that are likely to help reduce the risk of finding themselves negotiating a quality-of-care CIA for credentialing failures: ·· Verify that the Credentialing department has a well-publicized set of policies and procedures to outline the credentialing process, and confirm how it meets the requirements as defined in the bylaws of the organization; ·· Provide assistance to the medical staff leadership and the Quality department in educating providers on quality expectations, and provide them with regular feedback with respect to their individual contributions to quality of care; ·· Carefully scrutinize the “grandfathering” of privileges for a service or procedure; ·· Assist in collecting data, utilizing an organized and priority-driven system that identifies the data necessary to meet local and national regulatory requirements; ·· Verify that the Credentialing department obtains and reviews documentation with a well-structured approach; ·· Verify that the Credentialing department documents and stores primary documents and subsequent findings, which provides transparency and accessibility, and also demonstrates due diligence; ·· Confirm that the hospital bylaws describing the credentialing process are followed, including conducting searches of two available databases: the NPDB and the OIG’s LEIE;
  • 5. 888-580-8373  www.hcca-info.org  35 ComplianceToday  November2015 FEATURE ·· Review and monitor these databases routinely to screen for issues with staff members; ·· Confirm that the Credentialing department is performing ongoing monitoring and reviews of provider credentials to help validate that providers have the ability to provide services and procedures for which privileges have been granted; ·· Document efforts to help reduce these risks and increase quality of care, and present this information when negotiating a quality-of-care CIA. The compliance officer should help the board of directors understand the important role they often play in thoroughly reviewing candidates for appointment to the medical staff and also that they are not economi­ cally credentialing providers. Moreover, the compliance officer should be a partner in the credentialing and privileging process and should educate board members on their fiduciary duty with respect to their decision- making authority during credentialing and privileging procedures. The Credentialing department is often responsible for policies and procedures to help confirm that all providers are tracked, credentialed, and re-credentialed, but the Compliance department can also provide an independent assessment of the process to confirm that controls are in place and operating effectively. One way to do this is to take a sample of credentialing files and compare each file to the required documen­ tation to confirm that the credentialing file is complete, re-credentialing has been con­ ducted efficiently, and the required reviews and approvals have been obtained and documented. The Compliance department can also confirm whether all providers in the system are known and included in the credentialing process, and that the credentialing database is complete. Final thoughts Seeing that the OIG may view lack of proper credentialing as an actionable administrative and governance failure, healthcare entities should be cognizant of their current and future practices in this regard. OIG continues to monitor these efforts as outlined in their 2015 Work Plan. Healthcare entities should also accept that quality of care is considered a compliance issue, as demonstrated by recent FCA actions. Compliance professionals should take proactive steps to help mitigate potential quality-of-care and patient risks in a manner that incorporates broad stakeholder participation, strong controls, and clearly outlined processes. This publication contains general information only and Deloitte is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or other professional advice or services. This publication is not a substitute for such professional advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified professional advisor. Deloitte shall not be responsible for any loss sustained by any person who relies on this publication. 1. Department of Health and Human Services: 2014 OIG Work Plan, pg 7; 2015 OIG Work Plan, pg 20. Available at http://1.usa.gov/1LiEfk6 2. Social Security Act, 42. U.S.C. §1128, available at http://1.usa.gov/1LsbIMo and §1156, available at http://1.usa.gov/1GFMd4P 3. American Medical Association: Policy H-230.975 Economic Credentialing. Available at http://bit.ly/1R8WXhA 4. 42 CFR 482.22 - Condition of participation: Medical staff. Available at http://1.usa.gov/1NamzKo 5. Office of Inspector General: Divestiture Agreement. Available at http://1.usa.gov/1VPMmyW 6. Office of Inspector General: Corporate Integrity Agreement Frequently Asked Questions - List of Reportable Events. Available at http://1.usa.gov/17AqQ6m 7. United States Sentencing Commission: Federal Sentencing Guidelines, Chapter 8, §8C2.5(f). Available at http://bit.ly/1hCjXtl