AACU News & Notes

CMS Proposes to Recalibrate the Scope and Application of Stark Regulations

posted: October 30, 2019

Earlier this month, the Centers for Medicare and Medicaid Services (CMS) proposed noteworthy changes to regulations that interpret the Stark Law, a statute governing Medicare patient referrals and integrated care that hasn’t been significantly updated since it was enacted in 1989. The proposal promotes patient-centered payer reforms and is well-aligned with the AACU’s campaign to modernize the law restricting coordinated care.

In an official fact sheet describing the proposed rules, CMS admits that the Stark Law, in its current form, may actually inhibit cost savings. “The Stark Law has not evolved to keep pace with the transition to value-based care. In its current form, the Stark Law may prohibit some arrangements that are designed to enhance care coordination, improve quality, and reduce waste.”

Stark Law Proposal

  • Decouple the Stark Law from the Anti-Kickback Statute and other federal/state laws
  • Revise definition of “designated health services”
  • Revise definition of “physician”
  • Clarify definition of “referral”
  • Revise exception in the definition of “remuneration”
  • Clarify availability of “isolated transactions” exception
  • Modify guidance on “period of disallowance”

Therefore, CMS proposes new, permanent exceptions to the Stark Law for value-based arrangements that would apply “regardless of whether the arrangement relates to care furnished to people with Medicare or other patients.” In addition, the proposal calls for exceptions that would allow hospitals to donate certain cybersecurity technology to referring physicians, regardless of whether the parties operate in a fee-for-service or value-based payment system. CMS also wants the public to comment on “the role of price transparency in the context of the Stark Law and whether to require cost-of-care information at the point of a referral for an item or service.”

Additionally, as part of the Regulatory Sprint to Coordinated Care, the Department of Health and Human Services Office of Inspector General proposed several changes to the Anti-Kickback Statute that improve “coordination of care among physicians and other healthcare providers in both the Federal and commercial sectors.”

The AACU will comment on this proposal before the Dec. 31 deadline. Please contact our team with your own comments so we can better represent urologists’ interests.

Providers react to HHS proposal to revise Stark Law (FierceHealthcare, Oct 9, 2019)
HS will change how it enforces the Physician Self-Referral Law, or the Stark Law, and will allow exceptions for health care providers in agreements meant to reduce costs and improve patient health, according to Trump administration officials. The American Hospital Association supported the changes and CEO Rick Pollack said that out-of-date regulations have “created unnecessary roadblocks to the kind of collaboration and coordination that enables caregivers to meet all of their patients’ healthcare needs, whether in the hospital, the doctor’s office or their own homes.”
Bricker and Eckler (Oct 23); Katten Muchin Rosenman (Oct 17); RevCycle Intelligence (10/9)


Fact Sheet: Modernizing and Clarifying the Physician Self-Referral Regulations (CMS, Oct 9, 2019)

Proposed Regulation: Modernizing and Clarifying the Physician Self-Referral Regulations (CMS, Oct 17, 2019)

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