Early Reviews Positive for Proposed Stark Law, Anti-kickback Revamps

While still reading the fine print, stakeholders say they're pleased that CMS has taken steps to update the 30-year-old laws.

Key stakeholders are offering praise in their early reviews of proposals to update the Stark Law and Anti-kickback Statute unveiled Wednesday by the Centers for Medicare & Medicaid Services.

American Medical Association President Patrice A. Harris, MD, said the nation's largest physicians association "is still assessing the full scope of (Wednesday's) proposal," but was "pleased to see that the administration has acknowledged a need for policy revisions in response to potential barriers that impede the delivery of patient-centric care."

"The AMA has previously called on the administration to modify the regulations in order to facilitate the move to value-based care," Harris said in prepared remarks.

"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," he said.

Rick Pollack, president and CEO of the American Hospital Association applauded CMS "for putting patients first and taking action to modernize the rules so they support, rather than hinder, the teamwork among healthcare providers."

"When health care providers are able to work together to coordinate care, it is patients that benefit the most," Pollack said. "For far too long, a group of out-of-date regulations has created unnecessary roadblocks to the kind of collaboration and coordination that enables caregivers to meet all of their patients’ health care needs, whether in the hospital, the doctor’s office or their own homes."

Related: HHS Delivers Long-Awaited Stark Law Regulatory Overhaul

The CMS proposal would create new and permanent exceptions to the 30-year-old Stark Law for value-based arrangements, permitting physicians and other providers to try innovating solutions without fear that their legitimate efforts to coordinate care might violate the law, according to an agency fact sheet. Those new exceptions would apply for Medicare and non-Medicare populations alike.

"The proposed rules provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated care for patients," Health and Human Services Secretary Alex Azar said in a media release. "The proposals would ease the compliance burden for healthcare providers across the industry, while maintaining strong safeguards to protect patients and programs from fraud and abuse."

The HHS Office of Inspector General proposal would create three new safe harbors for certain forms of remuneration among eligible participants in value-based arrangements and make other changes, according to an OIG fact sheet.

Both CMS and OIG are soliciting public comments on the details of their proposals and related matters.

Ted Okon, executive director of the Community Oncology Alliance called the proposed reforms "an important first step towards making the dream of paying for cancer care based on value a reality."

However, he also warned that the proposed reforms could "accelerate the trend toward hospital acquisitions of community oncology practices and providers."

"COA is very concerned about hospitals taking advantage of changes to Stark Law and Anti-Kickback Statute to further monopolize cancer care and referrals," Okon said. "COA is hopeful that CMS and HHS will continue efforts to combat this, including site neutral payments and addressing misguided public policies that have driven the growth of hospital-based cancer care, such as the 340B Drug Pricing Program."

Clif Gaus, president and CEO of the National Association of ACOs, said the nation's ACOs   "strongly support the administration’s efforts to enhance value-based care, giving ACOs and other models tools needed to succeed, improving regulatory certainty, and reducing administrative burden."

Gaus said administration officials on Wednesday confirmed that the new proposals do not supersede or override current HHS waivers for ACOs participating in the Medicare Shared Savings Program.

"NAACOS would encourage HHS to underscore this positive news and clarify that these new proposals build upon and give additional flexibility for today's ACOs," Gaus said. 

NAACOS has asked HHS for additional clarity on patient sharing data, and how waivers apply to other models is welcomed.

Farzad Mostashari, MD, CEO and founder of the Aledade physician-led ACO network, and the former national coordinator for health information technology at HHS, said he was "glad to see the clarification of existing waivers to encourage more providers to adopt value-based and advanced payment models."

"Cooperation between providers to better coordinate and manage patient care is critical to the success of value-based arrangements for patients and providers alike," Mostashari said. "That said, it’s important that these rules safeguard against misuse by clinically integrated networks and provider groups who seek to control referral patterns and ultimately increase costs."