Articles Posted in Stark and Anti-Kickback

In her Federation of American Hospitals’ 2019 Public Policy Conference speech, CMS Administrator Seema Verma indicated the Stark Law would be receiving a major overhaul sometime in 2019. This update, according to Verma, will “represent the most significant changes to the Stark Law since its [1989] inception.”

One of the primary goals of this update is to ensure the policy maintains relevance in the modern health care world with the relatively recent implementation of electronic health records and cybersecurity. This includes the clarification of certain areas of noncompliance as well as reflection of the shift from a fee-for-service model to a value-based care model.

These regulatory modifications come in response to CMS’ public Request for Information (RFI) in June 2018 concerning adjustments that may be necessary in order to lessen any undue impact or burden brought about by the Stark Law. Specifically, CMS solicited responses regarding “the structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements, the need for revisions or additions to exceptions to the physician self-referral law, and terminology related to alternative payment models and the physician self-referral law.”

In its recent Advisory Opinion No. 17-05, OIG stated that the Proposed Arrangement (“Arrangement”) would not violate the anti-kickback statute (“AKS”) nor would it prompt administrative sanctions under the Civil Monetary Penalties (“CMP”) provision of the Social Security Act, prohibiting inducements to beneficiaries.

The Proposed Arrangement discussed in the Opinion centers around a retail pharmacy chain offering a voluntary membership program to Federal healthcare program beneficiaries that includes discounts on certain prescriptions and clinic services.

OIG further noted that Program Members receiving discounts would also be eligible to earn rewards in the form of credits when certain merchandise in-store photo-finishing services were purchased. On its face, the Arrangement would appear to invoke prohibitions of the CMP and AKS, since the discounted items and services and earned credits could induce a beneficiary to select the retail pharmacy chain as his or her supplier for federally reimbursable items or services.

New rules published on June 30th, 2016 in the Federal Register could dramatically change the regulatory enforcement landscape for healthcare providers, with fraud penalties nearly doubling under the False Claims Act and the Anti-Kickback Act.

The False Claims Act (which in pertinent part imposes penalties on healthcare providers for submitting false claims to a government program) has had a penalty range of $5,500 to $11,000 per claim since 1996, but such penalties will increase to a range of $10,781 to $21,563 per claim. Penalties for violations of the Anti-Kickback Act (which prohibits physicians from referring Medicare beneficiaries to an entity in which they have a financial relationship for designated health services) will correlatively be substantially enhanced, from $11,000 per violation to $21,563 per violation.

The basis for these adjustments is the Federal Civil Monetary Penalties Inflation Adjustment Act of 1990, which requires that civil monetary penalties be adjusted regularly in order to account for inflation. These changes are set to take effect on August 1st, 2016. Public comments on the changes can be submitted to the Justice Department until August 29th, 2016.