Over the past year, the Centers for Medicare & Medicaid Services (CMS) has engaged with the provider community in a discussion about regulatory burden issues. This included publishing a Request for Information (RFI) soliciting comments about areas of high regulatory burden. One of the top areas of burden identified in the over 2,600 comments received was compliance with the physician self-referral law (often called the “Stark Law”) and its accompanying regulations. In response to these concerns, CMS undertook a review of the existing regulations to determine where the agency could consider potential areas for burden reduction. In coordination with HHS Deputy Secretary Eric Hargan, CMS is now soliciting specific input on a range of issues identified with the Stark Law to help the agency better understand provider concerns and target its regulatory efforts to address those concerns.
The Stark Law was enacted in the 1980s to help protect Medicare and its beneficiaries from unnecessary costs and other harms that may occur when physicians benefit from referring patients to health care entities with which they have a financial relationship. The law prohibits a physician from making referrals for certain health care services to an entity with which he or she (or an immediate family member) has a financial relationship. There are statutory and regulatory exceptions, but in short, a physician cannot refer a patient to any service or provider in which they have a financial interest.
Stark also prohibits the entity from filing claims with Medicare for services resulting from a prohibited referral and Medicare cannot pay if the claims are submitted. In its current form, the physician self-referral law may prohibit some relationships that are designed to enhance care coordination, improve quality, and reduce waste.
To achieve a truly value-based, patient-centered health care system, doctors and other providers need to work together with patients. Many of the recent statutory and regulatory changes to payment models are intended to help incentivize value based care and drive the Medicare system to greater value and quality. This has been a priority of CMS and HHS and is reflected in many of our current ongoing initiatives. Medicare’s regulations must support this close collaboration. The Stark Law and regulations, in its current form, may hinder these types of arrangements. To help better understand the impediments to better coordinated care caused by existing regulatory efforts, this RFI seeks to obtain input about how to address those concerns.
We invite you to share your ideas and suggestions as we work together for coordinated care and a better health care system for all Americans. The RFI can be downloaded from the Federal Register at: https://www.federalregister.gov/public-inspection/.