HIMSS and PCHAlliance Comment on Updates to the Anti-Kickback and Physician Self-Referral Regulations

Two clinicians converse happily

HIMSS and the Personal Connected Health Alliance (PCHAlliance) provided written comments to the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) on two separate proposed regulations: OIG solicited comments on Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements; and CMS solicited feedback on Modernizing and Clarifying the Physician Self-Referral Regulations.

Both of these NPRMs were a request for feedback as a part of the Regulatory Sprint to Coordinated Care, an initiative launched by the US Department of Health & Human Services that aims to reduce the regulatory burdens that likely stifle innovation in healthcare. These particular regulations have many intersecting areas of opportunity as well as similarities in terms of obvious barriers to success with regard to the desire to move healthcare in the direction of a value-based delivery system.

Read the HIMSS-PCHAlliance comment letter in response to the Anti-Kickback Statute safe harbors and our comment letter on the Physician Self-Referral exceptions.

Overall, we focused our comment letters to OIG and CMS on the following topics:

Ensure greater clarity around technologies and entities that can engage safe harbors and exceptions as value-based enterprise (VBE) participants

We supported the application of protections for the potential VBE participants specified in the proposed regulations and endorsed the inclusion of additional VBE participants, including: health technology companies; medical device manufacturers; and, manufacturers, distributors, or suppliers of durable medical equipment, prosthetics, orthotics or suppliers (DMEPOS).

Emphasize that a full range of evidence-based tools and services will be needed to make value-based enterprises successful

In order for full risk sharing that incentivizes patient-centered, outcomes-driven care delivery to flourish, we argued that all providers must be able to access and use evidence-based tools and practices. Moreover, we stressed that technology is a crucial part of the health care provider’s toolbox and the proposal to exclude “medical equipment” will exclude clinical software, which is regulated and defined by the Food and Drug Administration as a medical device.

Create a new safe harbor to the Anti-Kickback Statute and a new exception in the Physician Self-Referral Regulation for donations of cybersecurity technology

We overwhelmingly supported this step forward as it represents a fundamental acknowledgement that this safe harbor and exception have the potential to remove real or perceived barriers to donations of cybersecurity technology and better address the growing threat of cyberattacks. The urgency and necessity of this new safe harbor and exception is heightened due to the growing availability of patient health information.

As more data exchange is encouraged and enabled, the adoption of robust cybersecurity solutions should be encouraged to effectively promote the continued flow of information as well as the evolving interoperability capabilities of electronic health records (EHR) and other health information technology. Moreover, with the additions of this safe harbor and exception, we supported providing clarity around any definitions as well as more examples, and also endorsed the proposal for an alternative means to obtaining cybersecurity hardware through a risk assessment.

Amend the existing safe harbors and exceptions for EHR arrangements

We supported the continuation of the EHR safe harbor and exception that protects certain arrangements involving the donation of interoperable EHR software or information technology and training services. Many of these proposals centered around textual clarifications as well as material definitions and amendments relating to cybersecurity that are intended to be aligned with the proposal for the aforementioned donation of cybersecurity technology.

Focus the 15-percent recipient contribution requirement only on certain providers

HIMSS and PCHAlliance supported a targeted exemption from the contribution requirement for certain providers, such as providers in rural or underserved areas, providers serving underserved populations, small providers (specifically sole practitioners or a practice with no more than 2 employed clinicians), Tribal providers, and critical access hospitals.

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