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On January 14, 2021, CMS finalized a regulatory definition for determining whether an item or service is reasonable and necessary for Medicare coverage purposes. Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of Reasonable and Necessary, 86 Fed. Reg. 2987 (Final Rule, January 14, 2021). In response to President Trump s October 3, 2019 Executive Order 13890 directing the Secretary of HHS to clarify the application of coverage standards, CMS explained that codifying reasonable and necessary will provide greater certainty to stakeholders seeking coverage for innovative items and services and to ensure that this substantive legal standard is codified. The effective date of the final rule is listed as
A pharmaceutical manufacturer has received a green light from the Office of Inspector General (OIG) to provide financial assistance for travel, lodging and other expenses to certain.
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A federally qualified health center (FQHC) received the go-ahead of the Office of Inspector General (OIG) to offer $20 gift cards as one-time incentives for pediatric patients who have previously missed at least two care appointments to reschedule and attend their appointments. The OIG reviewed the proposed incentive arrangement in Advisory Opinion No. 20-08, issued in December 2020, and determined that offering and providing the gift cards, as proposed by the FQHC, presents a low risk of fraud and abuse and does not constitute grounds for the imposition of sanctions under the under the Anti-Kickback Statute or the beneficiary inducement civil monetary penalties (CMP) law.
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On December 23, 2020, the OIG published Advisory Opinion 20-06, concluding that it would not impose penalties or sanctions under either the beneficiary inducement prohibitions of the civil monetary penalty statute (CMP) or the Anti-Kickback Statute(AKS) related to a management company providing Medicaid enrollment application assistance services to patients of skilled nursing facilities (SNFs) and home health agencies (HHAs) affiliated with the management company.
Overview of the Facts
The Requestors are a management company that provides financial, marketing and administrative services to SNFs and HHAs, and two SNFs and an HHA that are affiliated with the management company. Under the proposed arrangement, the affiliated SNFs and HHA would refer individuals they believe are eligible for Medicaid to the management company for Medicaid enrollment application assistance (Services). The individuals referred would be current
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In Advisory Opinion No. 20-05, posted September 23, 2020, OIG was unwilling to approve a pharmaceutical company s proposed cost-sharing subsidy program for beneficiaries seeking to use its expensive new drug for treatment of a rare cardiovascular disease. While OIG stated it was not in a position to reach a definitive conclusion regarding whether a violation of the federal Anti-Kickback Statute (AKS) existed, OIG was unwilling to issue a favorable advisory opinion. In particular, OIG was concerned that the arrangement would make beneficiaries less sensitive to the costs of their treatment, thereby risking an increase in the costs to the federal health care programs, and influencing clinical and beneficiary decision-making. Notably, OIG highlighted its use of publicly available information in reaching its conclusion under the AKS. With respect to the beneficiary inducement statute, OIG found the proposed arrangement did not