On February 9, 2018, Congress passed the Bipartisan Budget Act of 2018 (the Act), which included a number of important health law provisions..

AKS and CMP Violations

Under the Act, Congress doubled the statutory civil fines for certain violations of the Anti-kickback Statue (AKS) and adjusted certain fines under the Civil Monetary Penalty (CMP) Law. The Act also increased the maximum criminal penalty from $25,000 to $100,000 and increased the maximum incarceration period from five years to ten years.

Stark Law Revisions

Additionally, Section 50404 of the Act revises the Stark Law with respect to certain writing and signature requirements and holdover arrangements, which were previously addressed by CMS in guidance. The first revision comes directly from CMS commentary on satisfying the Stark law’s writing requirement. The revision codifies CMS’ position that “a collection of documents, including contemporaneous documents evidencing the course of conduct between parties involved” will satisfy the applicable Stark Law exceptions that require that an arrangement be set out in writing.  The second revision concerns the signature requirements  of Stark Law exceptions. The Act codifies CMS regulatory language that allows parties to obtain required signatures within 90 days if the arrangement satisfies the remaining requirements of the applicable exception. Finally, the Act revised the Stark Law to allow holdover leases or personal service arrangements to satisfy the applicable Stark Law exception, provided that certain conditions are met. The statutory language is now consistent with CMS regulations on holdover arrangements.

Telehealth Services

The Act also expanded Medicare coverage for telehealth services, including such services for patients with symptoms consistent with an acute stroke and end stage renal disease (ESRD). The coverage is effective as of January 1, 2019. In addition, beginning on January 1, 2020, telehealth services provided to beneficiaries assigned to an accountable care organization (ACO) will be covered when provided by physicians or practitioners participating in the ACO, even when provided to a patient in their home.

This post was co-authored by Chelsea Sousa, legal intern at Robinson+Cole. Chelsea is not yet admitted to practice law.