HHA proposed anticipated changes to kickbacks regulations and the physician self-referral law, known as the Stark Law, Oct. 9.
According to the agency, the changes will modernize and clarify the regulations that interpret the laws and hope to entice more physicians into value-based care arrangements.
“These proposed rules would be a historic reform of how healthcare is regulated in America,” HHS Deputy Secretary Eric Hargan said in a statement. “They are part of a much broader effort to update, reform, and cut back our regulations to allow innovation toward a more affordable, higher quality, value-based healthcare system, while maintaining the important protections patients need.”
The Office of Inspector General (OIG) of HHS published the proposed role as part of the agency’s initiative toward coordinated care. The proposed ruled addresses that civil monetary penalties for beneficiary inducements may be holding back value-based care arrangements. The current Federal anti-kickback statute does not allow providers to knowingly or willfully offer, pay, solicit or receive numerations for the referral of business paid by federal programs like Medicare or Medicaid.
The current laws do not provide these types of exceptions for value-based care arrangements.
“Any patient can tell you how difficult it is to coordinate their own care. This proposed rule would help patients to focus on their health, enable providers to better coordinate high-quality healthcare, and empower both to achieve improved health outcomes,” Acting Inspector General Joanne M. Chiedi said in a statement.
The proposals specifically offer new safe harbors for patients with value-based exceptions, acknowledging different incentives in value-based care. The proposal gives physicians new flexibility, according to HHS, while keeping oversight on anti-kickbacks. In general, the proposals allow healthcare providers to share more information about patients across care settings without running into trouble with the Stark Law.
“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,” HHS Secretary Alex Azar said in a statement.
The proposed rule was met with mixed reactions from the industry.
The American Medical Association was happy to see CMS address some of the barriers to physicians and care coordination from the Stark Law.
"Currently, the Stark Law and anti-kickback statute can have a negative impact on the ability of physicians to assist with coordination because they inhibit collaborative partnerships, care continuity, and the engagement of patients in their care," AMA President Patrice A. Harris, MD, MA, said in a statement. "These obstacles can hinder the health care system’s movement to value-based care."
However, the Medical Group Management Association (MGMA) saw the proposal as being too complicated and increasing regulations.
"For those fortunate medical groups that can utilize the new value-based exceptions, this proposal is a step in the right direction," Anders Gilberg, MGMA senior vice president, said in a statement. "Government Affair For medical groups that have been waiting years for relief from the complexity of the Stark law, this isn’t it.
"This rule adds layers upon layers to a regulatory scheme that was originally intended to provide bright-line guidance for medical practices, but never has. The new proposal fails to clarify fundamental issues related to group practices and confirms our longstanding position that Congress needs to change the law."
The National Association of ACOs (NAACOs) also viewed the proposed rule as complex, stating a need for more clarity about interaction with ACO rules from CMS.
Today’s proposed rules, which represent the first major update to the regulations since the Medicare Shared Savings Program was created, are complex and technical, and we are still reviewing," said Clif Gaus, ScD, president and CEO of NAACOs.