The RFI seeks to identify ways to amend or add new safe harbors to the Anti-Kickback Statute (AKS)1 and exceptions to the beneficiary inducement provisions of the Civil Monetary Penalty (CMP) statute,2 in order to foster arrangements that promote care coordination and advance the delivery of value-based care. The OIG notes that, through internal discussions and input from external stakeholders, it has identified the broad reach of these provisions as “potential impediment[s] to beneficial arrangements that would advance coordinated care.”
The OIG will accept comments on the RFI until October 26, 2018.
The RFI seeks information in several broad areas, requesting that commenters provide recommendations in each case on (a) how to structure arrangements between parties to alternative payment models; (b) what changes are needed in current safe harbors and beneficiary inducement CMPs, in order to promote beneficial care coordination, patient engagement, and value-based arrangements; and (c) associated terminology for these goals.
- Promoting care coordination and value-based care: The OIG seeks information regarding the structure and terms of potential arrangements involving care coordination, value-based arrangements, alternative payment models, arrangements involving innovative technology, and other novel financial arrangements. At the same time, it requests input on how these types of arrangements can prevent potential harms such as increased costs, inappropriate utilization, poor quality of care, and distorted decision making. In particular, the OIG asks what new or modified safe harbors to the AKS or exceptions to the CMP definition of remuneration are needed, and how “value” and other “critical terminology” should be defined (e.g., care coordination, clinical integration, gainsharing, outcomes-based care, risk sharing, and more).
- Beneficiary incentives and cost-sharing obligations: The OIG also requests information regarding the types of incentives providers, suppliers, and others would like to provide to beneficiaries, and how such incentives would contribute to or improve quality of care, care coordination, and patient engagement, including adherence to care plans.3 Furthermore, the OIG seeks information on how relieving or eliminating beneficiary cost-sharing obligations might improve care delivery, enhance value-based arrangements, and promote the quality of care.
- Intersection of the Stark Physician Self-Referral Law and Anti-Kickback Statute: The OIG seeks input on whether and how there should be alignment between exceptions to the Stark physician self-referral law and the AKS.
- Other related topics: The OIG also seeks comment in a number of related areas:
Fraud and abuse waivers: feedback on current waivers developed to test models by the Centers for Medicare and Medicaid Innovation (CMS) and carrying out the Medicare Shared Savings Program, including whether stakeholders have found compliance with the waivers to be challenging, whether specific waiver requirements are unduly burdensome, what waiver structures or conditions work well, how the governing body concept for accountable care organizations (ACOs) is working, and what pros and cons exist for fraud and abuse protections that are uniform across different CMS models, initiatives, and programs.
Cybersecurity-related items and services: the types of cybersecurity-related items or services that entities wish to donate or subsidize, and how existing fraud and abuse laws may pose barriers to such arrangements.
ACO beneficiary incentive program (section 50341(b) of the Bipartisan Budget Act of 2018): information regarding “other conditions” that this new safe harbor should include as protections or safeguards.
Telehealth (section 50302(c) of the Bipartisan Budget Act of 2018): information on how to define the new “telehealth technologies” exception in the beneficiary inducements CMP, whether the definition should also include services, and examples of those services.
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In recent years, the OIG has received an increasing number of comments in response to its annual safe harbor solicitation that current fraud and abuse provisions impede the use of value-based or outcomes-based arrangements among providers, suppliers, manufacturers, and others. The RFI is wide-ranging and demonstrates the complexity of the issues involved. It is one of several initiatives being contemplated by the OIG in conjunction with CMS to assess issues in the current regulations that may act as barriers to coordinated care.
On June 20, 2018, CMS issued an RFI relating to the federal self-referral law, commonly known as the Stark law. Various industry stakeholders have argued that the Stark law is stifling innovation, and that modifications are needed in order to further needed clinical and financial integration, health care delivery, and payment reform. In response, CMS has acknowledged that the Stark law may act as a barrier to coordinated care. Comments on that RFI were due on August 24, 2018.
Then, on July 18, 2018, the OIG submitted to the Office of Management and Budget for regulatory review a proposed rule that would have the effect of narrowing safe harbor protections under the AKS. The proposed rule, entitled “Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection,” if released, appears to follow through on various statements made by HHS Secretary Alex Azar suggesting that safe harbor protection under the AKS should be removed for prescription drug rebates; we discussed this issuance in our alert of July 20, 2018. It is unclear what new type of safe harbor, if any, may be proposed by OIG as a replacement.
We are seeing OIG and CMS reconsideration of some of the most fundamental precepts of fraud and abuse law that currently govern the multiple arrangements throughout the health care delivery system. Interested stakeholders should avail themselves of the opportunity to advocate for new needed protections to significant, emerging value-based and other arrangements.
If you are interested in commenting on the RFI or have questions, please do not hesitate to contact us.
- The AKS provided criminal penalties for individuals and entities that knowingly and willfully offer, pay, solicit or receive remuneration to induce or reward the referral of business reimbursable under federal health care programs. Certain payment practices are protected by “safe harbors.”
- The Beneficiary Inducement provisions imposes penalties against any person who offers or transfers remuneration to a Medicare or State health care program beneficiary that the benefactor knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier. The CMP Regulations codify certain statutory exceptions in the definition of “remuneration.”
- Among other inquiries, the OIG solicits comments on whether the OIG Policy Statement Regarding Gifts of Nominal Value to Medicare and Medicaid Beneficiaries should be updated.
Client Alert 2018-187
