Recent Cigna Settlements Demonstrate Government’s Continued Scrutiny of Medicare Advantage Organizations: Considerations for Plans, Providers, and Vendors

On September 29, 2023, Cigna agreed to pay $172 million—through two settlements¹—and to enter a corporate integrity agreement² with the Department of Health and Human Services, Office of Inspector General (“HHS-OIG”). The settlements resolved multiple civil health care fraud allegations against Cigna made by two U.S. Attorney’s Offices and a qui tam relator under the False Claims Act (“FCA”) concerning Cigna’s alleged submission of false and invalid diagnosis codes to artificially inflate government payments to Cigna under the Medicare Advantage program. More specifically, the settlements address, among other areas:

1. Cigna’s 360 program, which contracted with vendors to perform in-home assessments of Cigna’s Medicare Advantage members to ascertain diagnostic information for purposes of collecting and submitting additional diagnosis codes to the Centers for Medicare and Medicaid Services (“CMS”) for additional reimbursement (the “360 Program”).
2. Cigna’s use of retrospective chart reviews to identify additional risk-adjusting diagnosis codes without identifying or correcting diagnosis codes that were deemed unsubstantiated through those same reviews.
3. Cigna’s submission of diagnosis codes for morbid obesity that were not substantiated by medical record documentation. 

Notably, the Cigna settlements identify conduct across the current ongoing FCA litigation landscape related to submission of risk-adjusting diagnosis codes and highlight areas of ongoing scrutiny for Medicare Advantage Organizations (“MAOs”) as well as their contracted physician networks and vendors. In particular, the Cigna settlements emphasize the importance of establishing an adequate compliance apparatus when conducting in-home risk assessments, utilizing vendors to identify diagnostic information, and performing chart reviews.

Allegations

360 Program.

The government alleged that between January 1, 2012, and December 31, 2019, Cigna contracted with vendors that employed nurse practitioners or other licensed providers to conduct in-home assessments of Cigna’s members. Those providers would perform physical examinations of members and document diagnostic information on Cigna-provided or Cigna-approved forms, but allegedly were not permitted to provide treatment or prescriptions. Cigna’s medical coding team, allegedly, in turn reviewed the completed forms to identify diagnosis codes corresponding with the medical conditions checked off on the forms, which were then submitted to CMS as part of Cigna’s risk-adjustment data.

The government identified alleged features of the 360 Program as problematic under the False Claims Act, namely that (i) Cigna tracked the volume and nature of diagnoses generated by the vendors’ home visits and their impact on risk-adjusted payments; (ii) some of the diagnoses supplied by the vendors required laboratory evaluation, diagnostic imaging, or other diagnostic testing, but in many cases, Cigna did not require vendors conducting the in-home assessments to conduct such further evaluation; (iii) in many instances, the diagnoses reported by the vendors had not been previously reported to Medicare by Cigna for any other encounter with a provider during the year in which the home visit occurred; (iv) in many cases, the forms did not include clinical information that corroborated the diagnoses, including necessary diagnostic evaluation or testing to make a first-time diagnosis; and (v) in many cases, Cigna made insufficient effort to follow up with the patient or the patient’s primary care physician to ensure the patient sought and received treatment for conditions recorded through the 360 Program.

The government alleged that these practices violated Medicare Advantage coding requirements, including International Classification of Diseases (“ICD”) guidelines allowing coding for conditions diagnosed during outpatient visits “only when the condition exists at the visit, and it require(s) or affect(s) patient care treatment or management.”³ Because, according to the government, Cigna prevented vendor providers from offering medical care or treatment during in-home visits, the government contended that patients never received care or treatment for the diagnoses identified by vendors and, as such, Cigna knew that the diagnoses “did not, contrary to the ICD Guidelines, ‘require or affect patient care treatment or management’ during any medical encounter during the relevant date of service year.”⁴

One-Way Chart Review.

The government alleged that from 2014 to 2019, Cigna’s contracted vendors were instructed to conduct only retrospective reviews of medical records of services previously rendered to members to identify all risk-adjustment medical conditions supported by the records. Based on this review, Cigna allegedly submitted diagnosis codes to CMS to obtain additional risk-adjusted payments. The government alleged, however, that these chart reviews also identified instances when the medical record documentation did not substantiate the diagnosis codes that Cigna had submitted previously to CMS in its risk-adjusted data, but that Cigna did not investigate or withdraw the unsubstantiated diagnosis codes and nonetheless certified that the data it submitted to CMS was “accurate, complete, and truthful.” Accordingly, the government took issue with Cigna’s chart reviews that yielded only additional diagnosis codes (and payments) but did not result in corrections of diagnosis codes determined to be unsubstantiated.

Morbid Obesity Claims.

Finally, the government alleged that from 2016 to 2021, Cigna knowingly submitted or failed to delete inaccurate and untruthful diagnosis codes for morbid obesity to increase its risk-adjusted payments. According to the government, this conduct stemmed from various issues, including that some morbid obesity diagnoses resulted from Cigna’s chart review program, some were inaccurately reported by physicians and unsubstantiated by medical record documentation, and some related to members whose highest Body Mass Index (“BMI”) in medical record documentation fell below 35, the threshold BMI for the morbid obesity diagnosis codes at issue.

Key Takeaways

The Cigna settlements provide helpful insight into how plans should approach Medicare Advantage claim submissions and key pitfalls.

• The use of standardized forms to identify complex medical diagnosis may be inappropriate in the absence of necessary testing, imaging, or other diagnostic clinical assessments required to establish the diagnosis, as well as follow up to ensure patients actually receive evaluation and treatment for identified conditions. 
• The settlements signal the government’s continued skepticism of one-way chart reviews that result in submission of risk-adjusting diagnosis codes but not the withdrawal of diagnosis codes determined to be unsubstantiated. Such one-way chart review programs, particularly without adequate compliance measures to assure correction of unsubstantiated diagnosis codes, fail to satisfy the government’s requirement that MAOs identify and correct erroneous coding. As a result, plans should refrain from utilizing one-way chart reviews and ensure that they have processes in place to both (i) act upon negative findings from chart reviews and (ii) audit and monitor chart reviews.
• The settlements highlight the importance of substantiating diagnosis codes with adequate medical record documentation that is driven by actual care and treatment.  Indeed, the government in this case looked past the face of the documentation produced by providers via the 360 Program and concluded that the diagnostic information recorded by providers was insufficient given the absence of further testing, evaluation, or imaging that the government viewed as necessary to make such diagnoses. Plans should thus also be mindful to rely on medical record documentation that adheres to ICD-10 requirements such that coders may readily identify whether diagnoses are consistent with medical record documentation that is supported by adequate clinical evaluation and decision-making.
• Plans should ensure that they are implementing auditing and monitoring processes and taking corrective action when deficiencies are identified.
• The government did not pursue any of the vendors in this case, but likely had FCA theories available—and will continue to build on these potential theories of liability moving forward. Vendors furnishing services to plans, including those related to performing patient assessments or recording diagnostic information, should be mindful of potential government scrutiny.