COVID-19 Vaccine Update, PBM Regulations Upheld, and Advisory Opinion on CRNAs
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On December 2, 2021, Centers for Medicare and Medicaid Services (CMS) released a memorandum announcing that it will not enforce the new rule requiring vaccination of healthcare workers within Medicare and Medicaid‑certified facilities. This announcement follows two court-ordered injunctions prohibiting implementation and enforcement of the mandate, issued on November 29 and 30, 2021, in the United States District Court for the Eastern District of Missouri and the United States District Court for the Western District of Louisiana, respectively. CMS also specified that surveyors shall not survey healthcare providers for compliance with the mandate while the injunctions are in effect.
On November 10, the Office of Inspector General ("OIG") issued an Advisory Opinion regarding a proposed arrangement whereby a physician owner of a pain management practice would retain net profits from services provided by an employed certified registered nurse anesthetist (the "CRNA") pursuant to a reassignment of billing rights (the "Proposed Arrangement").
The OIG determined that the Proposed Arrangement implicates the federal Anti-kickback Statute due to the fact that, 1) the physician pays the CRNA remuneration in the form of salary payments in exchange for the CRNA furnishing anesthesia services, and 2) the CRNA's reassignment of billing rights to the physician owner gives the physician the opportunity to earn a profit from the CRNA's performance of services because, under the Proposed Arrangement, the physician owner would retain net profits from the escrow account it presently maintains on behalf of the CRNA and all future net profits.
However, notwithstanding the above, the OIG determined that the CRNA's salary component referenced above would be protected by the employment safe harbor of the federal Anti-kickback Statute, and the reassignment of billing, while not protected by a safe harbor, would present a sufficiently low risk of fraud and abuse and thus the OIG would not impose sanctions as a result.
On November 17, the Eighth Circuit Court of Appeals issued a decision to uphold a North Dakota law regulating pharmacy benefit managers ("PBMs") in the state. This decision stemmed from a 2017 lawsuit filed by a trade group representing PBMs which ended up in the Eighth Circuit after the US Supreme Court issued a decision stating that such laws were not preempted by federal law. The challenged law aims to provide oversight of pharmacy benefit managers, and includes provisions barring gag rules that limit what pharmacists can discuss with patients such as telling them of cheaper drug alternatives. The North Dakota law was backed by Attorneys General from nearly three dozen states.
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