On August 27, 2018, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a request for information that seeks public input on aspects of the Federal Anti-kickback Statue (AKS) and Civil Monetary Penalties law (CMP) which may act as barriers to coordinated care and value-based health care services.  OIG’s request for information intends to acquire and review information related to: (i) promoting care coordination and value-based care; (ii) beneficiary engagement incentives and cost-sharing obligations; (iii) current fraud, waste and abuse waivers; (iv) the donation or purchase of cybersecurity and telehealth technologies; (v) ACO beneficiary incentives; and (vi) ways to further align the AKS and the physician self-referral law (Stark Law).  OIG may use this information to further guide its effort to ameliorate AKS and CMP administrative burdens, and to transform the United States health care system into one that encourages and incentivizes health care providers to deliver coordinated health care and value-based services.

To accomplish its transformation goal, OIG will engage in a “regulatory sprint” which could include the issuance of rulemaking or guidance that will “encourage and incentivize coordinated care while protecting against harms caused by fraud and abuse.”  OIG’s transformation effort is particularly focused on topics that include, but are not limited to: (i) the structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements designed to promote care coordination and value; (ii) the need for new or revised safe harbors and exceptions to the definition of ‘‘remuneration’’ under the beneficiary inducements CMP to promote beneficial care coordination, patient engagement and value-based arrangements; and (iii) terminology related to alternative payment models, value-based arrangements and care coordination.  Through its regulatory sprint, OIG hopes to “foster arrangements that promote care coordination and delivery of value-based health care services.” 

Value-based arrangements and care coordination efforts may be particularly affected by OIG’s modification or addition of exceptions to the CMP definition of remuneration.  The CMP broadly prohibits offers or transfers of remuneration to patients if the offeror or transferor knows or should know that the remuneration is likely to influence the patient’s selection of a particular provider, practitioner, or supplier of any item or service.  Remuneration includes not only monetary payments, but also “anything of value” such as transportation or waivers of co-payments.  Some of the more interesting exceptions to remuneration include: (i) the “Access to Care Exception” which allows the offer or transfer of remuneration that promotes access to care, so long as it poses a low risk of harm to patients and federal health care programs; (ii) the “Financial-Need Exception” which permits offers or transfers of items and services for less than fair market value if certain conditions are met, such as an assessment of financial need; and (iii) the “Nominal Gifts Exception” which permits the provision of nominal value items and services valued at $15 individually and $75 in the annual aggregate.   

Although OIG recognizes many exceptions to the definition of remuneration, most of these exceptions lack specificity and are difficult to implement in the context of care coordination and value-based arrangements.  For example, the Access to Care Exception permits the offer or transfer of remuneration that promotes access to care, so long as it poses a low risk of harm to patients and federal health care programs.  However, the exception fails to specify what constitutes a “low risk of harm” and OIG has been historically reluctant to clarify this issue.  Stakeholders that may rely on CMP exceptions to guide value-based and coordinated care efforts could use the OIG request for information to gain clarity on the Access to Care Exception as well as a number of other CMP exceptions that affect these efforts.

Similarly, health care stakeholders could also use the request for information process to inform OIG of areas where the AKS poses an impediment to value-based arrangements and care coordination.  As a reminder, the AKS is a federal health care fraud and abuse statute that prohibits the exchange of remuneration for referrals for services that are payable by a federally funded health care program, unless the exchange of remuneration fits within an applicable safe harbor.  Some existing safe harbors that are relevant to care coordination include the safe harbors for: (i) personal services and management; (ii) electronic health record arrangements; (iii) warranties; (iv) transportation; and (v) promoting access to care.

However, many of these safe harbors are also not specifically tailored to protect value-based arrangements and care coordination efforts.  To better protect these transformative areas OIG will explore whether additional safe harbors for care coordination services arrangements or arrangements for the use of innovative technology could be added to the AKS.  In particular, OIG hopes that responders will identify appropriate requirements to protect against fraud and abuse in value-based arrangements and care coordination, as well as whether OIG should require stakeholders to disclose certain information to access these proposed safe harbors. HHS’s request for information presents a unique opportunity for health care providers to positively affect federal health care policy in ways that may expand access to care, reduce provider costs and improve health care quality and patient outcomes.  Responses may also help OIG alleviate some of the thorny administrative barriers affecting health care providers’ ability to provide coordinated care and value-based services.  If you or your organization is interested in responding to HHS’s request for information, or in learning more about HHS’s regulatory sprint, please contact your Dinsmore attorney.  Responses to HHS’s request for information must be received by October 26, 2018 at 5 p.m. EST.