Comments submitted to HHS by major healthcare organizations are overwhelmingly in support of the loosening of Stark and anti-kickback laws and the expansion of certain safe harbor exceptions.
HHS and CMS had proposed loosening the regulations earlier last year with final comments due Dec. 31, 2019. The American Hospital Association and Walmart suggested the feds could have gone even further in loosening the regulations.
The Stark laws and Anti-Kickback Statute have been on the books for three decades. Last year, the Trump administration proposed loosening the Stark Law to accommodate an ever-growing ecosystem of value-based payments within the Medicare and Medicaid programs. Of particular focus is relaxation of regulations to allow providers to seek some renumeration for certain value-based compensation arrangements.
CMS proposed loosening of physician self-referral rules for any value-based enterprise targeting a specific patient population where one of the entities is undertaking full financial risk for providing Medicare Part A and B for the first six months of the arrangement. Payments may be capitated or global.
The proposals put forth by CMS won nearly unanimous support in both the hospital and physician community, most of whom say they are chafing against the current law and regulations. An examination of comments made by some of the larger provider organizations and lobbying groups suggest not only strong support for relaxing Stark, but suggestions for additional loosening of regulations.
The Federation of American Hospitals, which represents primarily for-profit and investor-owned systems, said the proposed rules offered clarity. However, it also suggested that exceptions be expanded to include not only Medicaid and Medicare, but private payers as well.
"The FAH urges CMS to implement … with appropriate program oversight, non-CMS advanced payment models such as commercial payer-only arrangements," according to its comments. "The FAH believes that such an exception is necessary to ensure uniformity in the treatment of CMS-sponsored and non-CMS-sponsored models and further incentivize these innovative models."
The American Hospital Association, which represents primarily non-profit hospitals and healthcare systems, also urged CMS to further liberalize the Stark laws.
"CMS should not limit the definition of a value-based arrangement only to arrangements that involve care coordination or management … while care coordination and management are important elements in some value-based arrangement structures, they are not a common thread across all current structures and we believe that imposing so narrow a limitation would inhibit innovation now and in the future," AHA wrote.
One individual hospital system, Henry Ford Health System in Detroit, suggested CMS was too prescriptive in demanding that providers in a value-based arrangement that is in an exception return up to 25% of payments received if they do not meet financial goals.
"The specific requirement of a pay-back by the physician of 25% of the 'renumeration' if financial goals are not met seems unnecessarily precise, arbitrary, and prescriptive. We encourage CMS to consider moving to an entity-level definition of meaningful downside risk, expressed in terms like percent of total Part A and Part B payments (in an ACO example) or percent of episode target payments (in a bundled payment example)."
Walmart, which has made a huge bet on delivering targeted healthcare services to both its employees and consumers, desired an expansive definition of target populations for value-based arrangements.
"Patients living in the rural communities Walmart frequently serves would benefit from the broad definition of 'target patient population(s)' proposed by CMS. These patients often experience greater levels of poverty, face healthcare resource shortages, and may be less likely to receive necessary treatment for their health issues," the mega-retailer said. "They are disproportionately likely to suffer behavioral health disparities, less likely to receive mental health services, and more likely to receive fragmented care."
The final amendments to the Stark regulations are expected to be published later this year.