Source: https://it.scribd.com/document/53264129/CVS-Caremark-Corporate-Integrity-Agreement-With-DOJ-and-HHS-OIG
Timestamp: 2020-08-13 00:48:09
Document Index: 657052893

Matched Legal Cases: ['§ 1320', '§ 1320', '§ 1320', '§ 1320', '§ 552', 'art 5', '§ 5', '§ 1320', 'art 1005', '§ 1005', '§ 1005']

CVS Caremark Corporate Integrity Agreement With DOJ and HHS OIG | Regulatory Compliance | Audit Committee
CVS Caremark Corporation (CVS Caremark) hereby enters into this Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) to promote compliance with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) (Federal health care program requirements). The terms of this CIA shall be applicable to CVS Caremark’s retail pharmacy subsidiary, CVS Pharmacy, Inc., and any division of any of CVS’s subsidiaries or affiliates that conduct mail order pharmacy operations (collectively, “CVS”). Contemporaneously with this CIA, CVS Caremark is entering into a Settlement Agreement with the United States.
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CVS Caremark Corporation (CVS Caremark) hereby enters into this Corporate
Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United
States Department of Health and Human Services (HHS) to promote compliance with the
statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal
health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) (Federal health care
program requirements). The terms of this CIA shall be applicable to CVS Caremark’s
retail pharmacy subsidiary, CVS Pharmacy, Inc., and any division of any of CVS’s
subsidiaries or affiliates that conduct mail order pharmacy operations (collectively,
“CVS”). Contemporaneously with this CIA, CVS Caremark is entering into a Settlement
Prior to the execution of this CIA, CVS established a voluntary corporate
compliance program. CVS agrees to operate its compliance program in a manner that
meets the requirements of this CIA during the term of this CIA. CVS may modify the
compliance program as appropriate, but at a minimum, CVS shall ensure that the
compliance program meets the requirements of this CIA.
A. The period of the compliance obligations assumed by CVS under this CIA
shall be five years from the effective date of this CIA, unless otherwise specified. The
effective date shall be the date on which the final signatory of this CIA executes this CIA
(Effective Date). Each one-year period, beginning with the one-year period following the
Effective Date, shall be referred to as a “Reporting Period.”
CVS Caremark Corporate Integrity Agreement
B. Sections VII, VIII, IX, X, and XI shall expire no later than 120 days after
OIG’s receipt of: (1) CVS’s final annual report; or (2) any additional materials submitted
by CVS pursuant to OIG’s request, whichever is later.
1. “Covered Persons” includes:
a. all officers and directors of CVS; and
b. all employees, contractors, subcontractors, and agents of CVS or a
subsidiary, division, or affiliate of CVS who are engaged to furnish
pharmaceutical items or services to Federal health care program
beneficiaries or to prepare or submit claims for pharmaceutical
items or services to any Federal health care program.
Notwithstanding the above, this term does not include part-time or per diem
employees, contractors, subcontractors, agents, and other persons who are not reasonably
expected to work more than 160 hours per year, except that any such individuals shall
become “Covered Persons” at the point when they work more than 160 hours during the
2. “Relevant Covered Persons” includes: all officers, directors, and other
Covered Persons who are involved in corporate-level purchasing,
pricing, or dispensing decisions that affect reimbursement from Federal
3. “Therapeutic Interchange Program” refers to a company-wide effort or
practice to implement the substitution of a drug that has the same or
similar therapeutic effects as the drug originally prescribed based on
appropriate authorization of the prescriber. It does not refer to the
substitution of a chemically identical generic drug in the same dosage
and form as the branded drug originally prescribed that does not require
authorization of the prescriber under state law.
CVS has established and shall maintain a Compliance Program that includes the
1. Compliance Officer. Prior to the Effective Date of this CIA, CVS
appointed an individual to serve as its Compliance Officer and shall maintain a
Compliance Officer for the term of this CIA. The Compliance Officer is responsible for
developing and implementing policies, procedures, and practices designed to ensure
compliance with the requirements set forth in this CIA and with Federal health care
program requirements. The Compliance Officer shall continue to be a member of senior
management of CVS, shall make periodic (at least quarterly) reports regarding
compliance matters directly to the Audit Committee of the Board of Directors of CVS,
and shall be authorized to report on such matters to the Audit Committee of the Board of
Directors at any time. The Compliance Officer shall not be or be subordinate to the
General Counsel or Chief Financial Officer. The Compliance Officer shall continue to be
responsible for monitoring the day-to-day compliance activities engaged in by CVS as
well as for any reporting obligations created under this CIA.
CVS agrees to maintain the position of Compliance Officer during the term of this
CIA. CVS shall report to OIG, in writing, any changes in the identity or position
description of the Compliance Officer, or any actions or changes that would affect the
Compliance Officer’s ability to perform the duties necessary to meet the obligations in
this CIA, within 15 days of such a change.
2. Compliance Committee. Prior to the Effective Date of this CIA, CVS
established a corporate compliance committee (Compliance Committee). The
Compliance Committee shall, at a minimum, include the Compliance Officer and other
members of senior management necessary to meet the requirements of this CIA (e.g.,
senior executives of relevant departments, such as billing, clinical, human resources,
audit, and operations). The Compliance Officer shall continue to chair the Compliance
Committee and the Committee shall continue to support the Compliance Officer in
fulfilling his/her responsibilities (e.g., assist in the analysis of the organization’s risk areas
and oversee monitoring of internal and external audits and investigations). The
Compliance Committee shall make at least annual reports to Board of Directors of CVS.
CVS shall report to OIG, in writing, any changes in the composition of the
Compliance Committee, or any actions or changes that would affect the Compliance
Committee’s ability to perform the duties necessary to meet the obligations in this CIA,
within 15 days after such a change.
3. Audit Committee of the Board of Directors. CVS’s Board of Directors
currently has, and shall maintain during the term of the CIA, an Audit Committee
comprised of independent directors of CVS (hereinafter “Board Committee”). The Board
Committee is responsible for review and oversight of matters related to compliance with
the requirements of Federal health care programs and the obligations of this CIA. The
Board Committee shall, at a minimum, meet at least quarterly and shall review and
oversee CVS’s Compliance Program, including but not limited to the performance of the
Compliance Officer and Compliance Committee. CVS shall report to OIG, in writing,
any changes in the composition of the Board Committee, or any actions or changes that
would affect the Board Committee’s ability to perform the duties necessary to meet the
obligations in this CIA, within 15 days after such a change.
1. Code of Conduct. Prior to the Effective Date of this CIA, CVS
developed, implemented, and distributed a written Code of Conduct to all Covered
Persons. CVS shall make the promotion of, and adherence to, the Code of Conduct an
element in evaluating the performance of all employees. The Code of Conduct, at a
minimum, shall continue to set forth:
a. CVS’s commitment to full compliance with all Federal health
care program requirements, including its commitment to prepare and
submit accurate claims consistent with such requirements;
b. CVS’s requirement that all of its Covered Persons shall be
expected to comply with all Federal health care program
requirements and with CVS’s own Policies and Procedures as
implemented pursuant to this Section III.B (including the
requirements of this CIA);
c. the requirement that all of CVS’s Covered Persons shall be
expected to report to the Compliance Officer or other appropriate
individual designated by CVS suspected violations of any Federal
health care program requirements or of CVS’s own Policies and
d. the possible consequences to both CVS and Covered Persons of
failure to comply with Federal health care program requirements and
with CVS’s own Policies and Procedures and the failure to report
e. the right of all individuals to use the Disclosure Program
described in Section III.F, and CVS’s commitment to nonretaliation
and to maintain, as appropriate, confidentiality and anonymity with
Each Covered Person has certified, in writing or electronically, that he or she has
received, read, understood, and shall abide by CVS’s Code of Conduct. New Covered
Persons shall receive the Code of Conduct and shall complete the required certification
within 30 days after becoming a Covered Person or within 120 days after the Effective
Date, whichever is later.
CVS shall continue to periodically review the Code of Conduct to determine if
revisions are appropriate and shall make any necessary revisions based on such review.
To the extent CVS makes any material changes to the Code of Conduct, a revised Code of
Conduct shall be distributed and made available to Covered Persons within 60 days after
such changes are made and each Covered Person shall certify, in writing or electronically,
that he or she has received, read, understood, and shall abide by the revised Code of
Conduct within 30 days after the distribution of the revised Code of Conduct.
2. Policies and Procedures. To the extent not already implemented, within
120 days after the Effective Date, CVS shall implement written Policies and Procedures
regarding the operation of CVS’s compliance program and its compliance with Federal
health care program requirements. At a minimum, the Policies and Procedures shall
III.B.1;
b. the proper and accurate preparation and submission of claims to
Federal health care programs;
c. the reimbursement requirements of the Federal health care
programs, including the Maximum Allowable Cost (MAC)
programs maintained by states in which CVS does business, and
the Federal Upper Limit (FUL) program maintained by CMS;
d. the proper maintenance of prescription records;
e. the proper and accurate dispensing of prescription drugs,
including federal and state law requirements relating to prior
f. the establishment of a centralized process for developing
Therapeutic Interchange Programs that (i) considers the potential
impact of the Therapeutic Interchange Program to Federal health
care programs, and (ii) includes the documentation of relevant
information regarding the basis for the Therapeutic Interchange
Within 120 days after the Effective Date, the relevant portions of the Policies and
Procedures shall be made available to all Covered Persons whose job functions relate to
those Policies and Procedures. Distribution may include publishing such Policies and
Procedures on CVS’s intranet or other internal website available to all Covered Persons.
If CVS uses such an electronic method of distribution, it must notify the Covered Persons
that the Policies and Procedures will be distributed in such a manner and it must track the
distribution to ensure that all appropriate Covered Persons received the Policies and
Procedures. Appropriate and knowledgeable staff shall be available to explain the
At least annually (and more frequently, if appropriate), CVS shall assess and
update as necessary the Policies and Procedures. Within 30 days after the effective date
of any revisions, the relevant portions of any such revised Policies and Procedures shall
be made available to all individuals whose job functions relate to those Policies and
1. General Training. Within 150 days after the Effective Date, CVS shall
provide at least one hour of General Training to each Covered Person. This training, at a
minimum, shall explain CVS’s:
b. Compliance Program (including the Code of Conduct and the
Policies and Procedures as they pertain to general compliance
New Covered Persons shall receive the General Training described above within
30 days after becoming a Covered Person or within 150 days after the Effective Date,
whichever is later. After receiving the initial General Training described above, each
Covered Person shall receive at least one hour of General Training annually.
2. Specific Training. Within 120 days after the Effective Date, each
Relevant Covered Person shall receive at least two hours of Specific Training. This
Specific Training shall include a discussion of:
a. the applicable statutes, regulations, requirements, and directives
of the Federal health care programs relating to reimbursement,
including MAC programs maintained by the states and the FUL
program maintained by CMS;
b. drug substitution practices and examples of proper and improper
drug substitution practices as they relate to Federal health care
c. the legal sanctions for violations of the Federal health care
New Relevant Covered Persons shall receive this training within 30 days after the
beginning of their employment or becoming Relevant Covered Persons. After receiving
the initial Specific Training described in this Section, each Relevant Covered Person shall
receive at least one hour of Specific Training annually.
3. Certification. Each individual who is required to receive training shall
certify, in writing, or in electronic form, if applicable, that he or she has received the
required training. The certification shall specify the type of training received and the date
received. The Compliance Officer (or designee) shall retain the certifications, along with
all course materials. These shall be made available to OIG, upon request.
4. Qualifications of Trainer. Persons providing the training shall be
knowledgeable about the subject area.
5. Update of Training. CVS shall annually review the training, and, where
appropriate, update the training to reflect changes in Federal health care program
requirements, any issues discovered during internal audits or the Government
Reimbursement Review, and any other relevant information.
6. Computer-based Training. CVS may provide the training required
under this CIA through appropriate computer-based training approaches. If CVS chooses
to provide computer-based training, it shall make available appropriately qualified and
knowledgeable staff or trainers to answer questions or provide additional information to
the individuals receiving such training.
a. Engagement of Independent Review Organization. Within 120
days after the Effective Date, CVS shall engage an entity (or
entities), such as an accounting, auditing, or consulting firm
(hereinafter “Independent Review Organization” or “IRO”), to
perform the review described in Section III.D.2, below (Government
Reimbursement Review). Each IRO shall assess, along with CVS,
whether it can perform the IRO review in a professionally
independent and objective fashion, as appropriate to the nature of the
engagement, taking into account any other business relationships or
other engagements that may exist. The applicable requirements
relating to the IRO are outlined in Appendix A to this Agreement,
b. Frequency of Government Reimbursement Review. The
Government Reimbursement Review shall be performed annually
and shall cover each of the Reporting Periods. The IRO(s) shall
perform all components of each annual IRO Review.
c. Retention of Records. The IRO and CVS shall retain and make
available to OIG, upon request, all work papers, supporting
documentation, correspondence, and draft reports (those exchanged
between the IRO and CVS) related to the reviews.
2. Government Reimbursement Review. For each Reporting Period, the
IRO shall perform a review as follows:
a. Selection of State. Within 90 days of the end of each Reporting
Period, the IRO shall provide OIG with its recommendation for one state to be reviewed.
The state recommended by the IRO shall be a state that maintained a MAC program and
in which CVS did business during the Reporting Period. Within 30 days after OIG
receives the IRO’s recommendation, OIG shall notify the IRO if its recommendation is
acceptable. If OIG determines that the IRO’s recommendation is acceptable, the state
recommended by the IRO shall be reviewed. Absent notification from OIG that the
IRO’s selection is unacceptable, the IRO shall review the state it recommended. The state
selected pursuant to this process for each Reporting Period shall be referred to herein as
the “Selected State.”
b. Selection of Drugs. At least 90 days before the end of each
Reporting Period, the IRO shall provide OIG with its recommendation for three Drug
Entities to be reviewed in accordance with this Section III.D. For purposes of this CIA,
the term “Drug Entity” shall mean a molecular compound of which one or more forms or
strengths are approved for prescription use by the U.S. Food and Drug Administration,
and for which at least one available form or strength is included in the MAC program for
the Selected State or the FUL program. In choosing the three Drug Entities, the IRO shall
consider any drugs for which CVS has made significant corporate-level purchasing,
stocking, or dispensing decisions (including the implementation of any Therapeutic
Interchange Program(s)) during the current or previous Reporting Period. Within 30 days
after OIG receives the IRO’s recommendation, OIG shall notify the IRO if its
recommendation is acceptable. If OIG determines that the IRO’s recommendations are
acceptable, the drugs recommended by the IRO shall be reviewed in accordance with this
Section III.D. Absent notification from OIG that the IRO’s recommendations are
unacceptable, the IRO shall review the recommended drugs. Each drug selected pursuant
to this process for each Reporting Period shall be referred to herein as a “Selected Drug.”
c. Review. The IRO shall analyze CVS’s reimbursement from the
Selected State’s Medicaid Program for each available strength and form of each Selected
Drug during the Reporting Period. The IRO shall review information under CVS’s
control, including but not limited to claims submission and reimbursement data,
dispensing policies, drug substitution programs, Therapeutic Interchange Programs,
claims submission policies, as well as the FUL program and the Selected State’s
Medicaid policies and procedures (including the MAC program). The IRO shall
specifically determine whether CVS implemented any Therapeutic Interchange Program
for the purpose of (i) avoiding the Selected State’s MAC program or the FUL maintained
by CMS, (ii) circumventing the Selected State's Medicaid reimbursement or drug
dispensing rules, or (iii) otherwise violating any requirements of the Selected State’s
Medicaid Program. If the IRO so determines, the IRO shall perform a root cause analysis
to determine how the Therapeutic Interchange Program occurred based on information
available to CVS, interviews with relevant personnel, CVS policies and procedures,
supporting documentation regarding relevant prescriptions, and purchasing records. The
IRO shall recommend corrective action in order to prevent further Therapeutic
Interchange Programs based on avoiding the MAC or FUL programs, improperly
increasing aggregate reimbursement from the Medicaid Program, or otherwise violating
any requirements of the Selected State’s Medicaid Program.
3. Government Reimbursement Review Report. The IRO shall prepare a
report based upon each Government Reimbursement Review performed (Government
Reimbursement Review Report). Information to be included in the Government
Reimbursement Review Report is described in Appendix B.
4. Validation Review. In the event OIG has reason to believe that: (a)
CVS’s Government Reimbursement Review fails to conform to the requirements of this
CIA; or (b) the IRO’s findings or Government Reimbursement Review results are
inaccurate, OIG may, at its sole discretion, conduct its own review to determine whether
the Government Reimbursement Review complied with the requirements of this CIA
and/or the findings or Government Reimbursement Review results are inaccurate
(Validation Review). CVS shall pay for the reasonable cost of any such review
performed by OIG or any of its designated agents. Any Validation Review of Reports
submitted as part of CVS’s final Annual Report must be initiated no later than one year
after CVS’s final submission (as described in Section II) is received by OIG.
Prior to initiating a Validation Review, OIG shall notify CVS of its intent to
do so and provide a written explanation of why OIG believes such a review is necessary.
To resolve any concerns raised by OIG, CVS may request a meeting with OIG to: (a)
discuss the results of any Government Reimbursement Review submissions or findings;
(b) present any additional information to clarify the results of the Government
Reimbursement Review or to correct the inaccuracy of the Government Reimbursement
Review; and/or (c) propose alternatives to the proposed Validation Review. CVS agrees
to provide any additional information as may be requested by OIG under this Section in
an expedited manner. OIG will attempt in good faith to resolve any Government
Reimbursement Review issues with CVS prior to conducting a Validation Review.
However, the final determination as to whether or not to proceed with a Validation
Review shall be made at the sole discretion of OIG.
5. Independence/Objectivity Certification. The IRO shall include in its
report(s) to CVS a certification or sworn affidavit that it has evaluated its professional
independence and objectivity, as appropriate to the nature of the engagement, with regard
to the Government reimbursement Review and that it has concluded that it is, in fact,
Prior to the Effective Date of this CIA, CVS established a Disclosure Program that
includes a mechanism (e.g., a toll-free compliance telephone line) to enable individuals to
disclose, to the Compliance Officer or some other person who is not in the disclosing
individual’s chain of command, any identified issues or questions associated with CVS’s
policies, conduct, practices, or procedures with respect to a Federal health care program
believed by the individual to be a potential violation of criminal, civil, or administrative
law. CVS shall continue to appropriately publicize the existence of the disclosure
mechanism (e.g., via periodic e-mails to employees, posting on CVS’s intranet or other
internal website available to all Covered Persons, or by posting the information in
prominent common areas).
The Disclosure Program shall continue to emphasize a nonretribution,
nonretaliation policy, and shall continue to include a reporting mechanism for anonymous
communications for which appropriate confidentiality shall be maintained. Upon receipt
of a disclosure, the Compliance Officer (or designee) shall gather all relevant information
from the disclosing individual. The Compliance Officer (or designee) shall make a
preliminary, good faith inquiry into the allegations set forth in every disclosure to ensure
that he or she has obtained all of the information necessary to determine whether a further
review should be conducted. For any disclosure that is sufficiently specific so that it
reasonably: (1) permits a determination of the appropriateness of the alleged improper
practice; and (2) provides an opportunity for taking corrective action, CVS shall conduct
an internal review of the allegations set forth in the disclosure and ensure that proper
follow-up is conducted.
The Compliance Officer (or designee) shall maintain a disclosure log, which shall
include a record and summary of each disclosure received (whether anonymous or not),
the status of the respective internal reviews, and any corrective action taken in response to
the internal reviews. The disclosure log shall be made available to OIG upon request.
a. an “Ineligible Person” shall include any individual or entity who:
i. is currently excluded, debarred, suspended, or otherwise
ineligible to participate in the Federal health care programs or
ii. has been convicted of a criminal offense that falls within
the ambit of 42 U.S.C. § 1320a-7(a), but has not yet been
excluded, debarred, suspended, or otherwise declared
b. “Exclusion Lists” include:
i. the HHS/OIG List of Excluded Individuals/Entities
(available through the Internet at http://oig.hhs.gov); and
ii. the General Services Administration’s List of Parties
Excluded from Federal Programs (available through the
Internet at http://epls.arnet.gov).
c. “Screened Persons” shall include prospective and current owners
(other than shareholders who: (1) have an ownership interest of less
than 5%; and (2) acquired the ownership interest through public
trading), officers, directors, employees, contractors, and agents of
2. Screening Requirements. CVS shall ensure that all Screened Persons are
not Ineligible Persons, by implementing the following screening requirements.
a. CVS shall screen all Screened Persons against the Exclusion Lists
prior to hiring them or engaging their services and, as part of the
hiring or contracting process, shall require such persons to disclose
whether they are an Ineligible Person.
b. CVS shall screen all Screened Persons against the Exclusion Lists
within 120 days after the Effective Date and on an annual basis
c. CVS shall implement a policy requiring all Screened Persons to
disclose immediately any debarment, exclusion, suspension, or other
event that makes that person an Ineligible Person.
Nothing in this Section affects the responsibility of (or liability for) CVS to
refrain from billing Federal health care programs for items or services furnished, ordered,
or prescribed by an Ineligible Person.
3. Removal Requirement. If CVS has actual notice that a Screened Person
has become an Ineligible Person, CVS shall remove such person from responsibility for,
or involvement with, CVS’s business operations related to the Federal health care
programs and shall remove such person from any position for which the person’s
compensation or the items or services furnished, ordered, or prescribed by the person are
paid in whole or part, directly or indirectly, by Federal health care programs or otherwise
with Federal funds at least until such time as the person is reinstated into participation in
the Federal health care programs.
4. Pending Charges and Proposed Exclusions. If CVS has actual notice
that a Screened Person is charged with a criminal offense that falls within the ambit of 42
U.S.C. §§ 1320a-7(a), 1320a-7(b)(1)-(3), or is proposed for exclusion during his or her
employment or contract term, CVS shall take all appropriate actions to ensure that the
responsibilities of that person have not and shall not adversely affect the quality of care
rendered to any beneficiary, patient, or resident, or the accuracy of any claims submitted
to any Federal health care program.
G. Notification of Government Investigation or Legal Proceedings.
Within 30 days after discovery, CVS shall notify OIG, in writing, of any ongoing
investigation or legal proceeding known to CVS conducted or brought by a governmental
entity or its agents involving an allegation that CVS has committed a crime or has
engaged in fraudulent activities. This notification shall include a description of the
allegation, the identity of the investigating or prosecuting agency, and the status of such
investigation or legal proceeding. CVS shall also provide written notice to OIG within 30
days after the resolution of the matter, and shall provide OIG with a description of the
findings and/or results of the investigation or proceedings, if any.
a. Definition of Overpayments. For purposes of this CIA, an
“Overpayment” shall mean the amount of money CVS has received
in excess of the amount due and payable under any Federal health
care program requirements.
b. Reporting of Overpayments. If, at any time, CVS identifies or
learns of any Overpayment, CVS shall notify the payor (e.g.,
Medicare fiscal intermediary or carrier) within 30 days after
identification of the Overpayment and take remedial steps within 60
days after identification (or such additional time as may be agreed to
by the payor) to correct the problem, including preventing the
underlying problem and the Overpayment from recurring. Also,
within 30 days after identification of the Overpayment, CVS shall
repay the Overpayment to the appropriate payor to the extent such
Overpayment has been quantified. If not yet quantified, within 30
days after identification, CVS shall notify the payor of its efforts to
quantify the Overpayment amount along with a schedule of when
such work is expected to be completed. Notification and repayment
to the payor shall be done in accordance with the payor’s policies.
Notwithstanding the above, notification and repayment of any
Overpayment amount that routinely is reconciled or adjusted
pursuant to policies and procedures established by the payor should
be handled in accordance with such policies and procedures.
a. Definition of Reportable Event. For purposes of this CIA, a
“Reportable Event” means anything that involves:
i. a substantial Overpayment; or
ii. a matter that a reasonable person would consider a
probable violation of criminal, civil, or administrative
laws applicable to any Federal health care program for
which penalties or exclusion may be authorized.
A Reportable Event may be the result of an isolated event or a series
b. Reporting of Reportable Events. If CVS determines (after a
reasonable opportunity to conduct an appropriate review or
investigation of the allegations) through any means that there is a
Reportable Event, CVS shall notify OIG, in writing, within 30 days
after making the determination that the Reportable Event exists. The
report to OIG shall include the following information:
i. If the Reportable Event results in an Overpayment, the
report to OIG shall be made at the same time as the
notification to the payor required in Section III.H.1, and shall
include all of the information on the Overpayment Refund
Form, as well as:
(A) the payor’s name, address, and contact person to
whom the Overpayment was sent; and
(B) the date of the check and identification number (or
electronic transaction number) by which the
ii. a complete description of the Reportable Event, including
the relevant facts, persons involved, and legal and Federal
health care program authorities implicated;
iii. a description of CVS’s actions taken to correct the
Reportable Event; and
iv. any further steps CVS plans to take to address the
Reportable Event and prevent it from recurring.
In the event that, after the Effective Date, CVS changes the location of its
corporate headquarters or sells or purchases a business location related to the furnishing
of items or services that may be reimbursed by Federal health care programs, CVS shall
notify OIG of this fact within 60 days after the date of change of location, sale, or
purchase. This notification shall include the address of the new business unit or location,
phone number, fax number, Medicare Provider number, provider identification number
and/or supplier number, and the corresponding contractor’s name and address that has
issued each Medicare number. Each newly established and purchased business unit or
location shall be subject to all the requirements of this CIA.
A. Implementation Report. Within 150 days after the Effective Date, CVS shall
submit a written report to OIG summarizing the status of its implementation of the
requirements of this CIA (Implementation Report). The Implementation Report shall, at a
minimum, include:
1. the name, address, phone number, and position description of the
Compliance Officer required by Section III.A, and a summary of other noncompliance
job responsibilities the Compliance Officer may have;
or the Board Committee required by Section III.A;
3. a copy of CVS’s Code of Conduct required by Section III.B.1;
4. a copy of all Policies and Procedures required by Section III.B.2;
5. the number of individuals required to complete the Code of Conduct
certification required by Section III.B.1, the percentage of individuals who have
completed such certification, and an explanation of any exceptions (the documentation
supporting this information shall be available to OIG, upon request);
b. the number of individuals required to be trained, percentage of
individuals actually trained, and an explanation of any exceptions.
A copy of all training materials and the documentation supporting this information shall
be available to OIG, upon request.
7. a description of the Disclosure Program required by Section III.E;
8. the following information regarding the IRO(s): (a) identity, address, and
phone number; (b) a copy of the engagement letter; and (c) a summary and description of
any and all current and prior engagements and agreements between CVS and the IRO;
9. a certification from the IRO regarding its professional independence and
objectivity with respect to CVS;
10. the proposed start and completion dates of the Government
Reimbursement Review;
11. a description of the process by which CVS fulfills the requirements of
Section III.F regarding Ineligible Persons;
12. the name, title, and responsibilities of any person who is determined to
be an Ineligible Person under Section III.F; the actions taken in response to the screening
and removal obligations set forth in Section III.F; and the actions taken to identify,
quantify, and repay any overpayments to Federal health care programs relating to items or
services furnished, ordered or prescribed by an Ineligible Person;
13. a list of all states in which CVS does business, and the number of
CVS’s locations in each state; any names other than CVS under which any of CVS’s
locations are doing business; and the name and address of each Medicare contractor to
which CVS currently submits claims;
14. a description of CVS’s corporate structure, including identification of
B. Annual Reports. CVS shall submit to OIG annually a report with respect to the
status of, and findings regarding, CVS’s compliance activities for each of the five
1. any change in the identity, position description, or other noncompliance
job responsibilities of the Compliance Officer and any change in the membership of the
Compliance Commitee or the Board Committee described in Section III.A;
2. a summary of any significant changes or amendments to the Policies and
Procedures required by Section III.B and the reasons for such changes (e.g., change in
contractor policy) and copies of any compliance-related Policies and Procedures;
3. the number of individuals required to complete the Code of Conduct
with a copy of the IRO’s engagement letter (if applicable);
6. CVS’s response and corrective action plan(s) related to any issues raised
by the reports prepared pursuant to Section III.D;
7. summary and description of any and all current and prior engagements
and agreements between CVS and the IRO, if different from what was submitted as part
of the Implementation Report;
8. a certification from the IRO regarding its professional independence and
9. a summary of Reportable Events (as defined in Section III.H) identified
during the Reporting Period and the status of any corrective and preventative action
relating to all such Reportable Events;
10. a report of the aggregate Overpayments that have been returned to the
Federal health care programs. Overpayment amounts shall be broken down into the
following categories, if applicable: Medicare, Medicaid (report each applicable state
separately, if applicable), and other Federal health care programs. Overpayment amounts
that are routinely reconciled or adjusted pursuant to policies and procedures established
by the payor do not need to be included in this aggregate Overpayment report;
III.E that relate to Federal health care programs;
12. any changes to the process by which CVS fulfills the requirements of
13. the name, title, and responsibilities of any person who is determined to
be an Ineligible Person under Section III.F; the actions taken by CVS in response to the
screening and removal obligations set forth in Section III.F; and the actions taken to
identify, quantify, and repay any overpayments to Federal health care programs relating
to items or services furnished, ordered or prescribed by an Ineligible Person;
14. a summary describing any ongoing investigation or legal proceeding
required to have been reported pursuant to Section III.G. The summary shall include a
description of the allegation, the identity of the investigating or prosecuting agency, and
the status of such investigation or legal proceeding;
15. a description of all changes to the most recently provided list of
information required by Section V.A.13; a list of all states in which CVS does business,
and the number of CVS’s locations in each state; any names other than CVS under which
any of CVS’s locations are doing business; and the name and address of each Medicare
contractor to which CVS currently submits claims; and
The first Annual Report shall be received by OIG no later than 60 days after the
end of the first Reporting Period. Subsequent Annual Reports shall be received by OIG
no later than the anniversary date of the due date of the first Annual Report.
C. Certifications. The Implementation Report and Annual Reports shall include a
certification by the Compliance Officer that:
1. to the best of his or her knowledge, except as otherwise described in the
applicable report, CVS is in compliance with all of the requirements of this CIA;
2. he or she has reviewed the Report and has made reasonable inquiry
regarding its content and believes that the information in the Report is accurate and
3. to the best of his or her knowledge, CVS has complied with its
obligations under the Settlement Agreement: (a) not to resubmit to any Federal health
care program payors any previously denied claims related to the Covered Conduct
addressed in the Settlement Agreement, and not to appeal any such denials of claims; (b)
not to charge to or otherwise seek payment from federal or state payors for unallowable
costs (as defined in the Settlement Agreement); and (c) to identify and adjust any past
charges or claims for unallowable costs;
D. Designation of Information. CVS shall clearly identify any portions of its
submissions that it believes are trade secrets, or information that is commercial or
financial and privileged or confidential, and therefore potentially exempt from disclosure
under the Freedom of Information Act (FOIA), 5 U.S.C. § 552. CVS shall refrain from
identifying any information as exempt from disclosure if that information does not meet
the criteria for exemption from disclosure under FOIA.
Unless otherwise stated in writing after the Effective Date, all notifications and
reports required under this CIA shall be submitted to the following entities:
Telephone: 847-559-4714
Facsimile: 847-559-4953
Unless otherwise specified, all notifications and reports required by this CIA may
be made by certified mail, overnight mail, hand delivery, or other means, provided that
there is proof that such notification was received. For purposes of this requirement,
internal facsimile confirmation sheets do not constitute proof of receipt.
In addition to any other rights OIG may have by statute, regulation, or contract,
OIG or its duly authorized representative(s) may examine or request copies of CVS’s
books, records, and other documents and supporting materials and/or conduct on-site
reviews of any of CVS’s locations for the purpose of verifying and evaluating: (a) CVS’s
compliance with the terms of this CIA; and (b) CVS’s compliance with the requirements
of the Federal health care programs in which it participates. The documentation
described above shall be made available by CVS to OIG or its duly authorized
representative(s) at all reasonable times for inspection, audit, or reproduction.
Furthermore, for purposes of this provision, OIG or its duly authorized representative(s)
may interview any of CVS’s employees, contractors, or agents who consent to be
interviewed at the individual’s place of business during normal business hours or at such
other place and time as may be mutually agreed upon between the individual and OIG.
CVS shall assist OIG or its duly authorized representative(s) in contacting and arranging
interviews with such individuals upon OIG’s request. CVS’s employees may elect to be
interviewed with or without a representative of CVS present.
CVS shall maintain for inspection all documents and records relating to
reimbursement from the Federal health care programs, or to compliance with this CIA,
for six years (or longer if otherwise required by law) from the Effective Date.
Consistent with HHS’s FOIA procedures, set forth in 45 C.F.R. Part 5, OIG shall
make a reasonable effort to notify CVS prior to any release by OIG of information
submitted by CVS pursuant to its obligations under this CIA and identified upon
submission by CVS as trade secrets, or information that is commercial or financial and
privileged or confidential, under the FOIA rules. With respect to such releases, CVS
shall have the rights set forth at 45 C.F.R. § 5.65(d).
CVS is expected to fully and timely comply with all of its CIA obligations.
A. Stipulated Penalties for Failure to Comply with Certain Obligations. As a
contractual remedy, CVS and OIG hereby agree that failure to comply with certain
obligations as set forth in this CIA may lead to the imposition of the following monetary
penalties (hereinafter referred to as “Stipulated Penalties”) in accordance with the
1. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day
after the date the obligation became due) for each day CVS fails to establish and
implement any of the following obligations as described in Section III:
h. Notification of Government investigations or legal proceedings.
2. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day
after the date the obligation became due) for each day CVS fails to engage an IRO, as
required in Section III.D and Appendix A.
3. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day
after the date the obligation became due) for each day CVS fails to submit the
Implementation Report or the Annual Reports to OIG in accordance with the
requirements of Section V by the deadlines for submission.
4. A Stipulated Penalty of $2,500 (which shall begin to accrue on the day
after the date the obligation became due) for each day CVS fails to submit the annual
Government Reimbursement Review Report in accordance with the requirements of
Section III.D and Appendix B.
5. A Stipulated Penalty of $1,500 for each day CVS fails to grant access to
the information or documentation as required in Section VII. (This Stipulated Penalty
shall begin to accrue on the date CVS fails to grant access.)
6. A Stipulated Penalty of $5,000 for each false certification submitted by
or on behalf of CVS as part of its Implementation Report, Annual Report, additional
documentation to a report (as requested by the OIG), or otherwise required by this CIA.
7. A Stipulated Penalty of $1,000 for each day CVS fails to comply fully
and adequately with any obligation of this CIA. OIG shall provide notice to CVS, stating
the specific grounds for its determination that CVS has failed to comply fully and
adequately with the CIA obligation(s) at issue and steps CVS shall take to comply with
this CIA. (This Stipulated Penalty shall begin to accrue ten (10) days after CVS receives
this notice from OIG of the failure to comply.) A Stipulated Penalty as described in this
Subsection shall not be demanded for any violation for which OIG has sought a
Stipulated Penalty under Subsections 1-6 of this Section.
B. Timely Written Requests for Extensions. CVS may, in advance of the due
date, submit a timely written request for an extension of time to perform any act or file
any notification or report required by this CIA. Notwithstanding any other provision in
this Section, if OIG grants the timely written request with respect to an act, notification,
or report, Stipulated Penalties for failure to perform the act or file the notification or
report shall not begin to accrue until one day after CVS fails to meet the revised deadline
set by OIG. Notwithstanding any other provision in this Section, if OIG denies such a
timely written request, Stipulated Penalties for failure to perform the act or file the
notification or report shall not begin to accrue until three business days after CVS
receives OIG’s written denial of such request or the original due date, whichever is later.
A “timely written request” is defined as a request in writing received by OIG at least five
business days prior to the date by which any act is due to be performed or any notification
or report is due to be filed.
1. Demand Letter. Upon a finding that CVS has failed to comply with any
of the obligations described in Section X.A and after determining that Stipulated Penalties
are appropriate, OIG shall notify CVS of: (a) CVS’s failure to comply; and (b) OIG’s
exercise of its contractual right to demand payment of the Stipulated Penalties (this
notification is referred to as the “Demand Letter”).
2. Response to Demand Letter. Within ten days after the receipt of the
Demand Letter, CVS shall either: (a) cure the breach to OIG’s satisfaction and pay the
applicable Stipulated Penalties; or (b) request a hearing before an HHS administrative law
judge (ALJ) to dispute OIG’s determination of noncompliance, pursuant to the agreed
upon provisions set forth below in Section X.E. In the event CVS elects to request an
ALJ hearing, the Stipulated Penalties shall continue to accrue until CVS cures, to OIG’s
satisfaction, the alleged breach in dispute. Failure to respond to the Demand Letter in one
of these two manners within the allowed time period shall be considered a material breach
of this CIA and shall be grounds for exclusion under Section X.D.
3. Form of Payment. Payment of the Stipulated Penalties shall be made by
certified or cashier’s check, payable to: “Secretary of the Department of Health and
Human Services,” and submitted to OIG at the address set forth in Section VI.
4. Independence from Material Breach Determination. Except as set forth
in Section X.D.1.c, these provisions for payment of Stipulated Penalties shall not affect or
otherwise set a standard for OIG’s decision that CVS has materially breached this CIA,
which decision shall be made at OIG’s discretion and shall be governed by the provisions
in Section X.D, below.
a. a failure by CVS to report a Reportable Event, take corrective
action, and make the appropriate refunds, as required in Section
III.H;
including, but not limited to, the obligations addressed in Section
c. a failure to respond to a Demand Letter concerning the payment
of Stipulated Penalties in accordance with Section X.C; or
2. Notice of Material Breach and Intent to Exclude. The parties agree that
a material breach of this CIA by CVS constitutes an independent basis for CVS’s
exclusion from participation in the Federal health care programs. Upon a determination
by OIG that CVS has materially breached this CIA and that exclusion is the appropriate
remedy, OIG shall notify CVS of: (a) CVS’s material breach and OIG’s specific grounds
for its determination that CVS has materially breached this CIA; and (b) OIG’s intent to
exercise its contractual right to impose exclusion (this notification is hereinafter referred
to as the “Notice of Material Breach and Intent to Exclude”).
3. Opportunity to Cure. CVS shall have 30 days from the date of receipt of
the Notice of Material Breach and Intent to Exclude to demonstrate to OIG’s satisfaction
a. CVS is in compliance with the obligations of the CIA cited by
period, but that: (i) CVS has begun to take action to cure the
material breach; (ii) CVS is pursuing such action with due diligence;
and (iii) CVS has provided to OIG a reasonable timetable for curing
the material breach.
4. Exclusion Letter. If, at the conclusion of the 30-day period, CVS fails to
satisfy the requirements of Section X.D.3, OIG may exclude CVS from participation in
the Federal health care programs. OIG shall notify CVS in writing of its determination to
exclude CVS (this letter shall be referred to hereinafter as the “Exclusion Letter”).
Subject to the Dispute Resolution provisions in Section X.E, below, the exclusion shall go
into effect 30 days after the date of CVS’s receipt of the Exclusion Letter. The exclusion
shall have national effect and shall also apply to all other Federal procurement and
After the end of the period of exclusion, CVS may apply for reinstatement by submitting
a written request for reinstatement in accordance with the provisions at 42 C.F.R.
1. Review Rights. Upon OIG’s delivery to CVS of its Demand Letter or of
its Exclusion Letter, and as an agreed-upon contractual remedy for the resolution of
disputes arising under this CIA, CVS shall be afforded certain review rights comparable
to the ones that are provided in 42 U.S.C. § 1320a-7(f) and 42 C.F.R. Part 1005 as if they
applied to the Stipulated Penalties or exclusion sought pursuant to this CIA. Specifically,
OIG’s determination to demand payment of Stipulated Penalties or to seek exclusion shall
be subject to review by an HHS ALJ and, in the event of an appeal, the HHS
Departmental Appeals Board (DAB), in a manner consistent with the provisions in 42
C.F.R. § 1005.2-1005.21. Notwithstanding the language in 42 C.F.R. § 1005.2(c), the
request for a hearing involving Stipulated Penalties shall be made within 10 days after
receipt of the Demand Letter and the request for a hearing involving exclusion shall be
made within 25 days after receipt of the Exclusion Letter.
2. Stipulated Penalties Review. Notwithstanding any provision of Title 42
of the United States Code or Title 42 of the Code of Federal Regulations, the only issues
in a proceeding for Stipulated Penalties under this CIA shall be: (a) whether CVS was in
full and timely compliance with the obligations of this CIA for which OIG demands
payment; and (b) the period of noncompliance. CVS shall have the burden of proving its
full and timely compliance and the steps taken to cure the noncompliance, if any. OIG
shall not have the right to appeal to the DAB an adverse ALJ decision related to
Stipulated Penalties. If the ALJ agrees with OIG with regard to a finding of a breach of
this CIA and orders CVS to pay Stipulated Penalties, such Stipulated Penalties shall
become due and payable 20 days after the ALJ issues such a decision unless CVS
requests review of the ALJ decision by the DAB. If the ALJ decision is properly
appealed to the DAB and the DAB upholds the determination of OIG, the Stipulated
Penalties shall become due and payable 20 days after the DAB issues its decision.
3. Exclusion Review. Notwithstanding any provision of Title 42 of the
United States Code or Title 42 of the Code of Federal Regulations, the only issues in a
proceeding for exclusion based on a material breach of this CIA shall be:
a. whether CVS was in material breach of this CIA;
c. whether the alleged material breach could not have been cured
within the 30-day period, but that: (i) CVS had begun to take action
to cure the material breach within that period; (ii) CVS has pursued
and is pursuing such action with due diligence; and (iii) CVS
provided to OIG within that period a reasonable timetable for curing
the material breach and CVS has followed the timetable.
For purposes of the exclusion herein, exclusion shall take effect only after
an ALJ decision favorable to OIG, or, if the ALJ rules for CVS, only after a DAB
decision in favor of OIG. CVS’s election of its contractual right to appeal to the DAB
shall not abrogate OIG’s authority to exclude CVS upon the issuance of an ALJ’s
decision in favor of OIG. If the ALJ sustains the determination of OIG and determines
that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues
such a decision, notwithstanding that CVS may request review of the ALJ decision by the
DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the
exclusion shall take effect 20 days after the DAB decision. CVS shall waive its right to
any notice of such an exclusion if a decision upholding the exclusion is rendered by the
ALJ or DAB. If the DAB finds in favor of CVS, CVS shall be reinstated effective on the
date of the original exclusion.
4. Finality of Decision. The review by an ALJ or DAB provided for above
shall not be considered to be an appeal right arising under any statutes or regulations.
Consequently, the parties to this CIA agree that the DAB’s decision (or the ALJ’s
decision if not appealed) shall be considered final for all purposes under this CIA.
Consistent with the provisions in the Settlement Agreements pursuant to which
this CIA is entered, CVS and OIG agree as follows:
A. This CIA shall be binding on the successors, assigns, and transferees of CVS.
If CVS sells a business unit or location, OIG may release the business unit or location
from its obligations under the CIA provided that CVS has demonstrated to OIG’s
satisfaction that (1) such transaction constituted solely a disposition of assets of such
business unit or location; (2) the buyer is an independent entity unrelated in any manner
to CVS and has acquired the business unit or location at fair market value in an arms
length transaction; (3) the Federal health care program provider numbers have not
transferred to the successor entity; and (4) the business unit or location will not be
operated in whole or in part by CVS. If a business unit or location is no longer to be
considered subject to the CIA due to a sale, CVS shall require as a condition of the sale
that the buyer represents and agrees that it has or shall implement and maintain with
respect to its operation of the business unit or location an effective program to prevent
and detect violations of the legal requirements applicable to the delivery of goods and
services in connection with any health care benefits and that such a program will comply
with the provisions of the U.S. Sentencing Guidelines relating to corporate compliance
programs and will be mindful of any applicable guidance issued by OIG or other
components of HHS; and that the buyer agrees that it will maintain such program for at
least three years from the date of the sale or until the end of the term of this CIA,
B. This CIA shall become final and binding on the date the final signature is
obtained on this CIA;
C. Any modifications to this CIA shall be made with the prior written consent of
the parties to this CIA;
D. OIG may agree to a suspension of CVS’s obligations under this CIA in the
event of CVS’s cessation of participation in Federal health care programs. If CVS
withdraws from participation in Federal health care programs and is relieved of its CIA
obligations by OIG, CVS shall notify OIG at least 30 days in advance of CVS’s intent to
reapply as a participating provider or supplier with any Federal health care program.
Upon receipt of such notification, OIG shall evaluate whether this CIA should be
reactivated or modified.
E. The undersigned CVS signatories represent and warrant that they are
authorized to execute this CIA. The undersigned OIG signatory represents that he is
signing this CIA in his official capacity and that he is authorized to execute this CIA.
F. This CIA may be executed in counterparts, each of which shall constitute an original
and all of which taken together shall constitute one and the same Agreement. Facsimile
of signatures shall constitute acceptable binding signatures for purposes of this CIA.
ON BEHALF OF CVS CAREMARK CORPORATION
CVS Caremark Corporation DATE
Counsel for CVS Caremark Corporation DATE
GREGORY E. DEMSKE DATE
Documenti simili a CVS Caremark Corporate Integrity Agreement With DOJ and HHS OIG
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