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Under the proposed condition at 1001.952, the aggregate retail value of patient engagement tools and supports furnished by a VBE participant to a patient could not exceed $500 on an annual basis, with certain limited exceptions. As noted elsewhere in this preamble, our enforcement experience shows that incentives offered to beneficiaries can be used to coerce them into obtaining unnecessary services or harmful care, and this risk may be heightened when the value of remuneration is high or unlimited. However, we are unsure whether a monetary cap would present a barrier to achieving the intended benefits for patients envisioned by this proposed safe harbor. As discussed previously, we remain aware that the arrangements protected by the proposed substantial downside financial risk safe harbor would not be subject to programmatic requirements, oversight, or monitoring comparable to CMS-sponsored models. Accordingly, we are considering for the final rule including a requirement to submit information to the Department about the VBE, VBE participants, and the value-based arrangement similar to the requirement we are considering for the care coordination safe harbor at 1001.952.
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At games played with no spectators, CBS allowed its Skycam to be in positions over the stands that are not generally allowed in order to provide new angles. The NFL initially mandated the use of artificial crowd noise inside all stadiums with attendance below 10,000, consisting of non-dynamic ambience played at 70 decibels. The audio was monitored by the league and teams were subject to sanctions if they were found to have manipulated it . On September 25, these rules were adjusted, allowing the ambiance to be played at up to 80 decibels. The volume must be determined before the game and remain consistent through the entire game.
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These arrangements must be evaluated on a case-by-case basis for compliance with the statutes. We would interpret these requirements as described with respect to the care coordination arrangements safe harbor and would include them in this safe harbor for the reasons articulated there. We propose to exclude safe harbor protection for value-based arrangements that include marketing items or services to patients or patient recruitment activities. Our enforcement experience demonstrates that fraud schemes often involve the purchase of beneficiaries’ medical identity or other inducements to lure beneficiaries to obtain unnecessary care. This proposed safe harbor condition would protect beneficiaries and make clear that such coercive arrangements are not value-based arrangements protected by the proposed safe harbor. Accordingly, the proposed safe harbor would offer flexibility to improve quality of care, health outcomes, and efficiency while limiting the risk of the value-based arrangement being used as a marketing or recruiting tool to generate federally payable business for a VBE participant.
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- We do not believe safe harbors to the anti-kickback statute are the right tool to obviate these programmatic requirements.
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