The Trump administration should quickly approve changes to physician self-referral and anti-kickback rules, more than 120 healthcare organizations, trade groups, suppliers and vendors said in a letter Wednesday.
HHS, CMS and HHS' inspector general have been working on changes to Stark law and Anti-Kickback Statute regulations for several years, finally proposing new rules in October. Providers broadly support the changes but oppose the Trump administration's plan to make Stark Law exceptions conditional on meeting price transparency requirements.
The final rules have been held up by the White House budget office since July 21, but it's uncertain when it will approve them. Key stakeholders want the Office of Management and Budget to clear the changes as soon as possible.
"With the completion of this important work so close at hand, a single word from you would lift your team across the finish line," the organizations said in the letter.
A wide range of organizations cosigned the letter, including Ascension, Biogen, Cleveland Clinic, CommonSpirit, Federation of American Hospitals, HCA, Medtronic, Premier and SCL Health.
The healthcare industry spent years lobbying for changes to federal fraud and abuse regulations, telling regulators and lawmakers the rules prevented them from taking part in value-based arrangements and effectively coordinating care.
Congress created the Stark law and anti-kickback statute in 1989 to curb overutilization in the fee-for-service Medicare program. The rules block physicians from profiting off referrals to Medicare providers if they have a financial interest in them and from encouraging or rewarding anyone to buy or order federal-funded medical goods or services. Industry insiders say those rules make sense for a fee-for-service healthcare system, but changes are necessary for the industry to move past volume-based healthcare.
Some experts worry that relaxing physician self-referral rules and expanding safe harbors could increase fraud, so regulators will need to watch how the rule changes affect provider behavior.
In addition to creating challenges for the transition to value, physician self-referral and anti-kickback rules have affected the healthcare industry's response to the COVID-19 pandemic.