REGULATORY REVIEW


Data, Changes to Regulations Needed to Expand ASC-Payable List When will Medicare cover the full range of procedures ASCs perform? BY KARA NEWBURY


Advances in medical tech- nology have expanded the types of patients who can be treated outside the hospital. Despite these


advances, the Centers for Medicare & Medicaid Services’ (CMS) pay- ment policies often lag behind innova- tion, with many procedures—such as total joints—still on the inpatient-only list. For these procedures to migrate to the ASC setting, the ASC community will need to pursue changes to regu- lations that currently serve as road- blocks. ASCs also need to provide data that proves what we already know: these procedures are being done safely and effectively in the ASC setting at a lower cost to payers and patients.


The Innovation Center CMS has taken steps to pursue innova- tive payment and delivery of care mod- els. For example, the agency operates the Center for Medicare & Medicaid Inno- vation (the Innovation Center), which was established by Section 1115A of the Social Security Act (as added by section 3021 of the Affordable Care Act) for the purpose of testing “innovative payment and service delivery models to reduce program expenditures . . . while preserv- ing or enhancing the quality of care.” The Innovation Center awards grants to test various payment and service deliv- ery models that aim to achieve bet- ter care for patients, better community health and lower costs through improve- ment of the US health care system. ASCA applied for an Innovation


Center grant in 2013 to demonstrate the cost savings and high-quality outcomes associated with total joint replacements performed in the ASC setting. Unfortunately, ASCA’s proposal was not selected for funding, which meant that the ASCs that helped ASCA submit the proposal did not receive


20 ASC FOCUS MARCH 2016 ■ emergent in nature;


The approved procedures on Medicare’s ASC-payable list lag years behind the procedures that private payers cover in the ASC setting, mainly due to the exclusionary criteria that CMS medical directors use to establish that list.”


—Kara Newbury, ASCA


a waiver that would have allowed them to perform these procedures on Medicare beneficiaries for the first time and demonstrate to CMS that total joint replacements can be performed safely on this


patient population in


the ASC setting. Although ASCs have enjoyed great success with total joint replacements in privately insured patients, they have never been allowed to provide this service to Medicare beneficiaries because these procedures are not on Medicare’s ASC payable list. CMS medical directors use exclusionary criteria to establish that list.


Exclusionary Criteria Medicare’s ASC list of covered proce- dures is an “exclusionary list,” which means that ASCs are allowed to per- form any surgical procedure that is not designated as an “inpatient-only proce- dure” unless CMS has explicitly deter- mined the procedure would raise one or more specific safety concerns found at 42 CFR §416.166 and listed below: ■


poses a significant safety risk to the beneficiary;


typically requires active medical monitoring and care past midnight; ■ directly involves major blood vessels; ■


■


requires major or prolonged invasion of body cavities;


■ generally results in extensive blood loss;


■ life-threatening in nature; ■


■


commonly requires systemic throm- bolytic therapy; or


can only be reported using an unlisted surgical procedure code Every year during the rulemaking process, CMS evaluates the procedures excluded from the ASC-payable list and determines if any additional procedure should be moved to the ASC-payable list based on the criteria above. The criterion that is most problematic for ASCs is if the procedure “typically requires active medical monitoring and care past mid- night.” CMS uses a broad definition of “monitoring” and “care,” and even if ASCs are successful in moving total joints off of the inpatient-only list, CMS believes this will be a barrier for move- ment to the ASC-payable list. Many ASCs are equipped for overnight stays, and ASCA continues to work with CMS to come up with a policy that satisfies the medical directors’ safety concerns while allowing these procedures to be performed on the Medicare population. Through discussions with CMS med-


ical directors, it has also been made clear that patient outcomes data are necessary to move procedures that CMS deems more complex—such as total joint replacements—off of the inpatient-only list and, eventually, to the ASC-payable list. To expedite that process for total joint replacements, ASCA has devel- oped a research project to collect and aggregate the necessary data from facil- ities performing these procedures.


ASCA’s Surgical Outcomes Research Project ASCA has engaged KNG Health Con- sulting LLC (KNG) to collect and ana- lyze outcomes data needed to encour- age the migration of codes to the outpatient setting. The purpose of this project is to develop the evidence base


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