Module 7 - Corporate Integrity Agreements
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Module 7 | Christina Worley
Module 7 – Corporate Integrity Agreements
The three Corporate Integrity Agreements that I researched were with Freedom Health, Inc. and Optimum Healthcare, Inc. (2017), Pfizer, Inc. (2018), and Sierra Vista Regional Medical
Center and Twin Cities Community Hospital (2022). Background
Freedom Health, Inc. and Optimum Healthcare, Inc. entered into the Corporate Integrity Agreement after the organization and the former Chief Operating Officer were ordered to pay $32.5 million to settle False Claims Act allegations. The organization was accused of submitting unsupported diagnosis codes to Medicare, which resulted in inflated reimbursements. The CEO also wanted to expand their Medicare Advantage plans into more Florida counties, so he was involved in misrepresenting the network of physicians available in that region (Office of Public Affairs, 2017).
Pfizer, Inc. entered into a Corporate Integrity Agreement after they agreed to pay $23.85 million to settle claims that were in violation of the False Claims Act. Pfizer was using a foundation to pay the copays for Medicare beneficiaries who were taking three Pfizer drugs. Pharmaceutical companies are prohibited from offering to pay patient’s copays, which can entice
patients to use purchase Pfizer’s drugs. The scheme increased revenue for Pfizer and increased costs for Medicare (Office of Public Affairs, 2018). Twin Cities Community Hospital and Sierra Vista Regional Medical Center are both subsidiaries of Dignity Health, a not-for-profit health system. Dignity Health was ordered to pay $22.5 million in two separate settlements to settle claims that Twin Cities Community Hospital and Sierra Vista Regional Medical Center violated the False Claims Act. In 2014, Medi-Cal was
Module 7 | Christina Worley
expanding its coverage to the uninsured adult population. This expansion was funded by the federal government for the first three years and under contract if the organization did not spend at least 85% of their funds, they were required to pay back the state. The hospitals were submitting claims for “enhanced services” and the “enhanced services” were duplicates of services required to be rendered to their patients (Office of Public Affairs, 2022).
CIA-Changes in Compliance Requirements
One change I noticed in compliance requirements when comparing the Freedom Health, Inc. (2017) CIA to the Pfizer, Inc. (2018) CIA was under “Written Standards”. Both CIAs indicate that written policies and procedures regarding the operation of its compliance program should be implemented, but this section under Pfizer goes into greater detail. The CIA for Pfizer lists what policies and procedures should be implemented, specifically when dealing with Patient
Assistance Related Functions and ensuring that all functions are compliant with the Federal Anti-
Kickback Statute. Another change I noticed from the Freedom Health’s CIA in 2017 to Sierra Vista’s CIA in
2022 was in Appendix A of each CIA, “IRO Responsibilities”. Under this section, the CIA reviews what the responsibilities of the IRO are in reference to reviewing the organization. In the
Sierra Vista/Twin Cities Hospital CIA, there is a section that is not in the other two CIAs. It is titled “SV/TC Responsibilities” (Sierra Vista/Twin Cities). It states that the hospitals must ensure
that the IRO has access to all records necessary to complete their reviews and that all records provided are accurate and complete. A third change I noticed was in the “Compliance Committee” section under the Corporate
Integrity Obligations. In the 2018 Freedom Health CIA, it states that, “The Compliance Officer
Module 7 | Christina Worley
shall chair the Compliance Committee and the Committee shall support the Compliance in fulfilling his/her responsibilities” (Freedom Health, Inc. and Optimum Health, Inc., 2018, pg. 3). In the 2022 CIA for Sierra Vista/Twin Cities Hospital, this section goes into more detail, stating, “The Compliance Committee shall be responsible for, among other things, reviewing the training
required by Section III.C below at least annua, implementation and oversight of the risk assessment and internal review process required by Section III.E below, and the development and implementation of the Transition Plan required by Section III.J below” (Sierra Vista Regional Medical Center and Twin Cities Community Hospital, 2022).
One last change I noticed was with the requirement of a Transition Plan. A transition plan
addresses how the compliance program will continue to include the compliance program requirements once the CIA has expired. In the 2018 Freedom Health CIA and the 2019 Pfizer, Inc. CIA, there is no mention of a Transition Plan; however, in the 2022 Sierra Vista/Twin Cities CIA, a Transition Plan is required to be implemented prior to the end of the fourth Reporting Period and it must be approved by the Board. The Compliance Committee is responsible for developing and implementing the Transition Plan. CIA Format Changes
After reviewing and researching these Corporate Integrity Agreements, I was able to see that many items remained the same, while there were some changes to the format. I noticed that the CIAs have common elements but there are sections that are tailored to the facts regarding the conduct that led to the settlements. Of the changes I noticed, I believe this happened because the OIG wants to increase effectiveness of compliance programs and make updates when it realizes that compliance needs to evolve. There are many healthcare providers and organizations that will
take advantage of Medicare and Medicaid, so it only makes sense that the OIG must up their
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Module 7 | Christina Worley
game when it comes to the Corporate Integrity Agreements. The Transition Plan was interesting to me as it helps the organization to think about compliance once the CIA has expired. It made me think that maybe some organizations were not taking compliance seriously and once their CIA was completed, compliance was no longer a priority. With so many schemes and fraudulent activity happening in the healthcare sector, it is important that the CIA have very specific wording to ensure that the organization remains compliant. I also noticed the increased role that the Compliance Committee has been assigned; in the 2022 Sierra Vista/Twin Cities CIA, the wording if extremely specific as to what responsibilities the committee has and that it must mee the requirements of specific sections of the CIA. I believe this was done to spell out specifically what role the Compliance Committee should be taking when it comes to compliance in the organization.
Module 7 | Christina Worley
References
Office of Inspector General. (2022). Corporate integrity agreement between the office of inspector general and the department of health and human services and sierra vista regional medical center and twin cities community hospital. Retrieved from https://oig.hhs.gov/fraud/cia/agreements/Sierra_Vista_Regional_Medical_Center_and_Twin_Citi
es_Community_Hospital_12052022.pdf
Office of Inspector General. (2018). Corporate integrity agreement between the office of inspector general and the department of health and human services and freedom health inc. and optimum healthcare, inc. Retrieved from https://oig.hhs.gov/fraud/cia/agreements/Freedom_Health_Inc_and_Optimum_Healthcare_Inc_0
5112017.pdf
Office of Inspector General. (2019). Corporate integrity agreement between the office of inspector general and the department of health and human services and pfizer, inc. Retrieved from https://oig.hhs.gov/fraud/cia/agreements/Pfizer_Inc_05232018.pdf
Office of Public Affairs. (2022, December 7). Three health care providers agree to pay $22.5 million for alleged false claims to california’s medicaid program. Retrieved from https://www.justice.gov/opa/pr/three-health-care-providers-agree-pay-225-million-alleged-false-
claims-california-s-medicaid
Office of Public Affairs. (2017, May 30). Medicare advantage organization and former chief operating officer to pay $32.5 million to settle false claims act allegations. Retrieved from https://www.justice.gov/opa/pr/medicare-advantage-organization-and-former-chief-operating-
officer-pay-325-million-settle
Module 7 | Christina Worley
Office of Public Affairs. (2018, May 24). Drug maker pfizer agrees to pay $23.85 million to resolve false claims act liability for paying kickbacks. Retrieved from https://www.justice.gov/opa/pr/drug-maker-pfizer-agrees-pay-2385-million-resolve-false-claims-
act-liability-paying-kickbacks
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