On March 6, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) issued a favorable advisory opinion (AO 19-03) allowing a nonprofit medical center (Requestor) to provide free, in-home follow-up care to eligible individuals with certain high-acuity conditions (the Arrangement).1 The OIG concluded that, while the Arrangement could potentially generate prohibited remuneration under the Anti-Kickback Statute (AKS) and the Civil Monetary Penalties Law (CMPL), the Arrangement presented sufficiently low risk that the OIG would not impose administrative sanctions. The OIG’s favorable advisory opinion suggests a potentially progressive shift in how the OIG may view innovative arrangements that implicate the fraud and abuse laws, but nevertheless stand to benefit patients by improving quality of care and lowering costs to the federal fisc.
Requestor provides a range of inpatient and outpatient hospital-based services and is affiliated with a clinic that offers primary and specialty services at several facilities located within the same geographic region (the Clinic). Requestor and the Clinic operate as part of an integrated health system that serves patients across three states. Requestor currently offers a program to provide free, in-home follow-up services to patients with congestive heart failure (CHF) who have recently been admitted as an inpatient and are deemed, according to an industry-recognized assessment tool, as being at high risk of readmission. Requestor proposes to expand the program to certain patients with chronic obstructive pulmonary disease (COPD) who present for care at Requestor or a Clinic site and are deemed, using the same assessment tool or a predictive analytics tool, as being at high risk for hospital readmission or admission, respectively. Requestor certifies that the goals of the Arrangement are to:
- Increase patient compliance with discharge plans;
- Improve patient health; and
- Reduce hospital inpatient admissions and readmissions.
The Arrangement includes the following:
- Patients will not be automatically eligible to participate in the Arrangement and, instead, will be screened by Requestor’s clinical nurse leaders after they have already expressed an intention to receive CHF- or COPD-related follow-up care from Requestor;
- Patients who meet the eligibility criteria and elect to participate in the Arrangement will receive two visits per week from a Requestor-employed community paramedic for approximately 30 days following enrollment. Each visit occurs in the patient’s home or assisted living facility and lasts approximately 60 minutes. During the visit, the community paramedic performs some or all of the following activities:
- Medication review;
- Assessment of the patient’s need for follow-up appointments;
- Monitoring of compliance with the patient’s discharge plan or disease management protocol;
- A home safety inspection; and
- A physical assessment (g., vital sign measurements, blood tests, wound checks, listening to the patient’s heart and lungs); and
- The community paramedics providing these services are not compensated based on the number of patients who enroll in the Arrangement, and all costs associated with the in-home visits are allocated to, and assumed by, Requestor.
Notably, Requestor will not offer patients the opportunity to participate in the Arrangement as a means of encouraging their selection of Requestor’s facilities for follow-up care, nor will Requestor advertise, market, or publicize the existence of the Arrangement on its website. Finally, Requestor certified that it does, and will continue to, offer the Arrangement to any patient satisfying the eligibility criteria, regardless of his or her payor source or ability to pay for medical services.
In analyzing the current and proposed expanded versions of the Arrangement, the OIG found that the free healthcare services and in-home care management offered by Requestor constitute a significant benefit to patients, including Federal healthcare program beneficiaries. The OIG noted that at least one state Medicaid program in Requestor’s service area reimburses for similar community paramedic services, thereby reinforcing that the offerings have value.
Having found that the current and prospective iterations of the Arrangement implicate the CMPL’s beneficiary inducement provision, the OIG then considered whether the CMPL’s promotes access to care exception could be invoked to protect the Arrangement.2 Reiterating its prior commentary on the applicability of this exception, the OIG acknowledged that items and services that remove impediments to compliance with a treatment plan or provide support for patients post-discharge could qualify as promoting access to care.3 However, the OIG concluded that the Arrangement as a whole would not meet this exception because at least one of the services involved – the home safety assessment – could not fairly be construed as improving patients’ ability to obtain federally reimbursable items or services or eliminating barriers to accessing care.
Notwithstanding its conclusion that the Arrangement falls outside the promotes access to care exception, the OIG ultimately determined that the Arrangement presents sufficiently low risk that the OIG, “in an exercise of [its] discretion,” would not impose sanctions under the beneficiary inducement provision of the CMPL or the AKS for the following reasons:4
- Benefits Outweigh Risk of Inappropriate Patient Steering: The OIG emphasized that the risk of the Arrangement incentivizing patients to choose Requestor or the Clinic for their CHF- or COPD-related care was negligible since they already would have made that decision prior to being offered the ability to participate in the Arrangement. With respect to future, unrelated services, community paramedics do and will continue to inform patients of their freedom to obtain care from any provider of their choosing. These safeguards, combined with Requestor’s stated goal of improving patient health, allowed the OIG to conclude the Arrangement poses a low risk of harm.
- Arrangement Unlikely to Increase Program Costs through Overutilization or Inappropriate Utilization: To the extent the Arrangement results in increased utilization of services, the OIG observed that this would likely consist of medically necessary and appropriate care (g., medications that patients were reminded to take or follow-up appointments scheduled). In fact, the OIG recognized that if the Arrangement functions as intended, it could result in overall savings to the Federal healthcare programs through enhanced patient health and reduced admissions or readmissions.
- Low Risk of Interference with Clinical Decision-Making: Given Requestor’s certification that it does not and will not compensate any employee or contractor in a manner tied to the volume of patients enrolled in the Arrangement, the OIG found the risk of skewed clinical decision-making to be low.
- Lack of Advertising or Marketing of Arrangement to the Public: The OIG emphasized that the absence of any advertising or marketing of the Arrangement to the public lowers the risk that the benefits are being used to induce patients’ selection of Requestor or the Clinic for CHF- or COPD-related follow-up care.
- Appropriate Tailoring of Services to Meet Requestor’s Patient Care Goals: Finally, the OIG noted that the scope and duration of the services provided through the Arrangement appears reasonably tailored to achieve the objectives articulated by Requestor through improved continuity of care, quality, and patient safety.
Notably, the favorable outcome of this advisory opinion suggests a potentially more flexible approach by the OIG when it comes to evaluating arrangements that technically implicate the fraud and abuse laws, but which stand to meaningfully advance the goals of value-based care. In fact, this opinion dovetails nicely with HHS’s Regulatory Sprint to Coordinated Care, an ongoing initiative designed to identify and eliminate the regulatory barriers that impede providers’ ability to participate in innovative arrangements seeking to promote high quality care while reducing costs.
Toward that end, in approving this Arrangement, the OIG explicitly cited to a statement in its August 27, 2018 Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP that the OIG “has identified the broad reach [of these statutes] as a potential impediment to beneficial arrangements that would advance coordinated care.”5 The OIG further acknowledged that it is “mindful that health care providers may wish to offer the type of services provided under the Arrangement[ ] to deliver higher quality care that improves the health of patients and may decrease overall costs to Federal health care programs.”6
As noted above, the OIG found that the Arrangement in this case did not meet the CMPL’s promotes access to care exception. The fact that the entire Arrangement was deemed to fall outside the exception based on the OIG’s conclusion that a small aspect of the offering did not technically promote compliance with a treatment regimen or remove barriers to care demonstrates a narrow view of this exception by the OIG. Nevertheless, the outcome of the opinion suggests that, even in the absence of formal regulatory amendments as part of the Regulatory Sprint to Coordinated Care, the OIG may consider taking a more progressive view through its advisory opinion process of arrangements that technically implicate the AKS or CMPL but also enhance quality of care and reduce costs to Federal healthcare programs.
Finally, and to keep things in perspective, all of the OIG’s advisory opinions are highly dependent on the facts certified by the specific requestor. Thus, the applicability of each advisory opinion to arrangements outside of the particular arrangement reviewed by the OIG is limited. While advisory opinions can give useful insight into how the OIG would evaluate comparable offerings, it’s important to be mindful of these limitations when considering whether an organization can provide a similar type of benefit to patients.
If you would like additional information about this advisory opinion and how it relates to your organization’s operations, please contact the authors.
1 OIG Advisory Opinion No. 19-03 (Mar. 6, 2019).
2 See 42 U.S.C. § 1320a-7a(i)(6)(F); 42 C.F.R. § 1003.110. The CMPL’s promotes access to care exception permits the offer or provision of items or services that: (1) improve a beneficiary’s ability to obtain items and services payable by Medicare or Medicaid; and (2) pose a low risk of harm to Medicare and Medicaid beneficiaries, as well as the programs, by being unlikely to interfere with or skew clinical decision-making, being unlikely to increase costs to the Federal healthcare programs or beneficiaries through overutilization or inappropriate utilization, and not raising patient safety or quality of care concerns.
3 See 81 Fed. Reg. 88,368, 88,394–97 (Dec. 7, 2016).
4 OIG Advisory Opinion No. 19-03 at 7.
5 Id. at 9 (quoting 83 Fed. Reg. 43,607, 43,608 (Aug. 27, 2018)).