The American Telemedicine Association this week issued a statement in response to the U.S. Department of Health and Human Services’ final rules regarding the Physician Self-Referral Law (also known as the Stark Law) and the Federal Anti-Kickback Statute.
According to HHS, the rules will allow healthcare providers to participate in value-based arrangements with more flexibility and will ease compliance burdens.
“We applaud HHS and CMS for taking an important and urgently needed step towards modernizing the laws that are critical to the success of the regulatory sprint to coordinated care,” said ATA CEO Ann Mond Johnson in a statement.
“These new rulings move us closer to a value-based care model that will allow our healthcare system to reimagine how care is delivered and integrate telehealth with in-person care,” she said.
WHY IT MATTERS
The agency’s final rules come as part of its efforts to examine the federal regulations potentially standing in the way of advancing value-based care.
The HHS Office of Inspector General’s final rule, “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements,” implements seven new safe harbors, modifies four existing safe harbors and codifies one new exception under the Beneficiary Inducements CMP.
The final safe harbor regulations protect value-based arrangements and modify the existing safe harbor for electronic health records items and services, among other changes. They also protect telehealth for in-home dialysis, among the several reforms the ATA advocated for in a December letter to the HHS.
Meanwhile, the Centers for Medicare and Medicaid Services’ final rule, “Modernizing and Clarifying the Physician Self-Referral Regulations,” notes that the existing framework is tailored to a fee-for-service model.
By contrast, “the final rule opens additional avenues for physicians and other healthcare providers to coordinate the care of the patients they serve – allowing providers across different healthcare settings to work together to ensure patients receive the highest quality of care,” wrote CMS in a fact sheet.
Taken together, advocates and policymakers say the changes will allow for more innovation in patient care.
“OIG’s final rule, and the CMS final rule to the extent the Stark Law is applicable, would facilitate a range of arrangements to improve the coordination and management of patient care and the engagement of patients in their treatment if all applicable regulatory conditions are met,” said HHS in a press statement.
As one example: “A primary care physician or other provider may wish to furnish a smart tablet that is capable of two-way, real-time interactive communication between the patient and his or her physician. The patient’s access to a smart tablet could facilitate communication through telehealth and the provision of in-home services.”
“These new laws will help to drive value-based care and improve the coordination of patient care across care settings, [and] ease unnecessary regulatory burden on physicians and other healthcare providers, while reinforcing the goal of the physician self-referral laws,” said Johnson, “to protect patients from unnecessary services and be steered to less convenient, lower-quality or more expensive services because of a physician’s financial self-interest.”
THE LARGER TREND
The ATA was among several organizations that responded to HHS’ requests for comment regarding changes to both the Anti-Kickback Statute and the Stark Law last year, with many respondents saying the law had not kept up with the evolution to a value-based system.
The policies have arguably stood in the way of innovation as well: The laws have historically presented a potential risk to parties entering into telehealth arrangements.
“An example of a telehealth arrangement that could implicate both laws would be an arrangement where a hospital engages a physician to provide on-call telestroke services, where the hospital provides the equipment to the physician and pays the physician an hourly rate for his or her services,” said Douglas Grimm, a health law partner at Arent Fox, in January last year.
ON THE RECORD
“We are pleased that the HHS has taken action to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system into one that pays for value and promotes the delivery of coordinated care,” said Johnson. “The ATA looks forward to continuing to work with the Administration to ensure that these rules can be implemented effectively.”