HHS provides first look at proposed changes to Stark Law

WASHINGTON - The Department of Health and Human Services has proposed changes to the Stark Law that would, among other things, create new exceptions that recognize incentives are different in healthcare systems that pay for value- vs. volume-based care.

The proposal includes proper safeguards that ensure the Stark Law will continue to provide meaningful protection against overutilization and other harms, while giving physicians and other healthcare providers added flexibility to improve the quality of care for their patients, HHS says.

“Our proposed rules would be an unprecedented opportunity for providers to work together to deliver the kind of high-value, coordinated care that patients deserve,” said HHS Secretary Alex Azar.

HHS published a request for information in the Federal Register in June, asking for feedback on “how to address any undue regulatory impact and burden of the physician self-referral law.”

The proposal also includes changes to the Anti-Kickback Statute and the Civil Monetary Penalties Law that would address longstanding concerns that these laws limit the ways in which healthcare providers coordinate patient care. The changes would offer flexibility for innovation and improved coordinated care through, for example, outcome-based payment arrangements that reward improvements in patient health. The changes would also make it easier for physicians and other healthcare providers to ensure they are complying with the law by offering specific safe harbors for these arrangements.

Examples of activities that could be protected by the changes include:

. A specialty physician practice could share data analytics services with a primary care physician practice.

. A hospital could provide the discharged patients' physicians with care coordinators to ensure patients receive appropriate follow-up care, data analytics systems to help physicians ensure that their patients are achieving better health outcomes, and remote monitoring technology to alert physicians or caregivers when a patient needs healthcare intervention to prevent unnecessary ER visits and readmissions.

. A physician practice could provide smart pillboxes to patients without charge to help them remember to take their medications on time.

. A hospital could improve its cybersecurity and the cybersecurity of nearby providers that it works with frequently.  To do so, it could donate, for free, cybersecurity software to each physician that refers patients to its hospital.

. A nephrologist, dialysis facility, or other provider could furnish patients with end-stage kidney disease with technology that is capable of monitoring the patient's health and two-way, real-time interactive communication between the patient, facility, and physician. In addition, the facility could equip the physicians with data analytics software to help them monitor patients' health outcomes.