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CMS Releases FY 2022 IPPS and LTCH Proposed Rule | Holland & Knight LLP

Highlights
The Centers for Medicare & Medicaid Services (CMS) on April 27, 2021, released the Fiscal Year (FY) 2022 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) Prospective Payment System (PPS) Proposed Rule, which will affect discharges occurring on or after Oct. 1, 2021.
The Proposed Rule would update the payment policies and annual payment rates for the inpatient payment system, update various quality programs and evaluate New Technology Add-On Payment (NTAP) applications, among other changes.
Comments on the Proposed Rule are due by June 28, 2021, and a final rule is expected by Aug. 1, 2021.
The Centers for Medicare & Medicaid Services (CMS) on April 27, 2021, released the Fiscal Year (FY) 2022 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) Prospective Payment System (PPS) Proposed Rule, which will affect discharges occurring on or after Oct. 1, 2021. A CMS fa ....

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AGG Food & Drug Newsletter - April 2021 | Arnall Golden Gregory LLP

Federal
Register notice finally announcing the fee rates under the Over-the-Counter (OTC) Monograph Drug User Fee Program for Fiscal Year 2021. As we discussed in a previous Bulletin, the CARES Act, among other things, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow FDA to assess and collect user fees from qualifying owners of OTC monograph drug facilities and qualifying submitters of OTC monograph order requests (OMORs). The fees are meant to support FDA in its OTC monograph drug activities, including inspections of facilities associated with such products. More >
Arbitration as an Alternative to the Backlogged Courts ....

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FDA Establishes – And HHS Immediately Withdraws – New OTC Drug User Fee Rates | King & Spalding

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Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for OTC monograph drug product contract manufacturing organizations (“CMOs”). The annual facility fee for OTC monograph drug manufacturers – the so-called Monograph Drug Facility (“MDF”) fee – was set at $14,060,[i] and the annual facility fee for CMOs was set at $9,373.[ii] According to the notice, for FY 2021, facility fees would have come due February 12, 2021.[iii]
However, just two days later, on December 31, 2020, the Department of Health and Human Services (“HHS”) withdrew the FDA notice and directed FDA to cease enforcement of the OTC user fees[iv] at least for the time being. HHS’ action responded to criticism that fees would apply to OTC hand sanitizer manufact ....

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