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Dateline DC: An overview of recent DAHP responses to requests for feedback from regulatory agencies

The ACS submits numerous comments to rules, responses to requests for information, and other letters to the DHHS each year.

ACS

February 1, 2020

The American College of Surgeons (ACS) Division of Advocacy and Health Policy submits numerous comments to rules, responses to requests for information, and other letters to the Department of Health and Human Services each year. Below, a few recently submitted comment letters are highlighted.

CPI RFI on the future of program integrity

The ACS submitted comments to the Center for Program Integrity (CPI) in response to its request for information (RFI) about ways to modernize the Centers for Medicare & Medicaid Services’ (CMS) strategies to combat fraud, waste, and abuse in the Medicare program. The College urged CMS to address the numerous process flaws associated with prior authorization (PA)—a utilization management mechanism that often delays patient care and creates administrative burdens for surgeons—in order to limit the application of PA and eliminate trivial barriers to physician payment. In addition, the ACS encouraged CMS to streamline certification of medical necessity requirements and standardize audit functions across the agency’s contractors. The College also made recommendations regarding enhancements to insurers’ provider directories, as well as program integrity policies for value-based payment models.

CMS Transparency in Coverage proposed rule

The ACS commented on CMS’ Transparency in Coverage proposed rule, through which the agency solicited feedback on approaches to make health care price information accessible to consumers. In its letter, the College offered guidance to CMS on methods to enhance the usability and accuracy of cost-sharing data private payors present to their enrollees. The ACS recommended the following: that price information should reflect both the cost of an entire episode of care, as well as patient-specific insurance benefits; that payors should be required to notify consumers about any prerequisites to coverage in a timely manner; and that payors’ online self-service tools should be configured to allow users to search for cost-sharing information for a given item or service using various refining functionalities, including physician network status, specialty, and quality rating.

CMS and OIG physician self-referral and anti-kickback statute proposed rule

The ACS commented on a pair of linked proposed rules from CMS and the Office of the Inspector General (OIG) related to the physician self-referral law (commonly known as the “Stark Law”) and the anti-kickback statute. These policies were put in place decades ago to prevent the practice of referring patients to an affiliated practice for services in exchange for compensation and other perceived abuses. However, in recent years with the growth of Alternative Payment Models with more integrated or coordinated care structures, these policies have been seen as an impediment to innovation for fear of running afoul of the rules and incurring substantial penalties. The ACS comments indicated support of many of the policies to create more certainty around these provisions and their existing exceptions and safe harbors while cautioning against stringent definitions that could hamper future innovation.

FDA draft guidance on clinical decision support software

The Food and Drug Administration (FDA) has long regulated medical devices, including Clinical Decision Support (CDS) software, defined as software that provides clinicians and patients with knowledge, intelligently filtered and presented at appropriate times, to enhance health care. For CDS, the FDA proposed to use a risk-based framework to determine the level of regulation that would apply. Though supportive of the concept of using a risk-based framework, the College raised several questions about the proposed framework itself—specifically, that it is outdated and lacks clarity. The ACS also noted that software that is considered “low risk” in the proposed framework, and thereby exempt from regulation, could still cause patient harm if the software does not function in the way it is described. The College also stressed the importance of the FDA carefully examining the increased risk to patient safety presented by CDS that is based on technology using artificial intelligence.

For more information on the regulatory comments and ACS advocacy efforts, contact regulatory@facs.org.