The United States Department of Health and Human Services issued two sweeping new proposed rules designed to ease regulatory burdens on providers.
On Oct. 9, HHS submitted its changes to the Medicare Physician Self-Referral Law, more commonly known as the Stark law, and the Federal Anti-Kickback Statute. The department said its proposal will “modernize and clarify the regulations” of the outdated health care laws.
Modernizing the Outdated Stark Law
The Centers for Medicare & Medicaid Services advised that the proposed rule supports CMS’s “patients over paperwork” initiative. The changes aim to reduce regulatory burden on physicians and other health care providers, while also protect patients from unnecessary, lower quality or more expensive services based on physicians’ financial interests.
With these proposed changes, CMS said the agency hopes to improve:
CMS said the Stark law needed modernizing. The law was drafted in 1989 and was based primarily on a fee-for-service health care payment model. CMS said the Stark law is antiquated and did not evolve to address value-based and coordinated-care payment models.
According to CMS, the proposed rule does the following:
CMS is also soliciting comments about the role of price transparency in the context of the Stark law and whether the government should require “cost-of-care information at the point of a referral for an item or service.” Both President Trump and CMS have made clear that price transparency is necessary to transform America’s health care system. CMS said that such pricing information “could empower patients to have conversations about cost with their physicians at the point of care and serve as an additional safeguard at the point of referral.”
Updating the Anti-Kickback Statute to Promote Payment for Value and Coordinated Care
The HHS Office of the Inspector General also issued a proposed rule to update the regulations implementing the Federal Anti-Kickback Statute and the civil monetary penalty for beneficiary inducements. The OIG acknowledged that the broad reach of these statutes potentially inhibits “beneficial arrangements” that could advance the transition to value-based care and improve coordination of patient care among providers and across care settings. According to the OIG, the proposed rule will “promote coordinated patient care and foster improved quality, better health outcomes, and improved efficiency.”
The new regulation would create:
Also, the proposal would modify or amend:
The Stark law and Anti-Kickback Statute proposals will receive a lot of attention from stakeholders over the next several months. Stakeholders who desire to file a comment on the proposed Stark or Anti-Kickback rules may do so by filing a comment with CMS or the OIG, respectively, by no later than Dec. 31.
If you have any questions regarding the proposed changes or would like to comment on the proposed rules, please contact one of the health care lawyers at Phelps Dunbar.