1 . LIFE SCIENCES REGULATORY FRAMEWORK
1.1 Legislation and Regulation for Pharmaceuticals and Medical
Devices
The primary legislation governing the authorisation, marketing,
sale and supply of pharmaceutical products by the US Food and Drug
Administration (FDA) is the Federal Food, Drug, and Cosmetic Act
(FD&C Act), which has been amended many times over the years to
reflect increasing FDA mandates for the regulation of
pharmaceutical products. The Public Health Service Act (PHS Act) is
the specific authority utilised to approve or license biologic
(including biosimilar) products. The primary FDA regulations
governing drugs and biologics are found at Chapter 21 of the Code
of Federal Regulations. Controlled substances, such as opioids, are
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CMS Announces Proposed Rate Increases and Other Changes for Skilled Nursing Providers and Hospice Providers in Fiscal Year 2022 Tuesday, April 13, 2021
On April 8, 2021, the Center for Medicare & Medicaid Services (“CMS”) announced a proposed rate increase of 1.3 percent for skilled nursing providers in fiscal year 2022. It is estimated this will result in approximately $444 million increase in payments to skilled nursing facilities (SNF) under Medicare Part A for the fiscal year. This increased payment rate does not incorporate the SNF Value-Based Program (VBP) reductions that CMS estimates to be $184.25 million for FY 2022.
CMS is also looking at three additional fiscal areas. First, it is looking at whether it should recalibrate the Patient Driven Payment Model (PDPM) Parity Adjustment. A parity multiplier is applied for PDPM components to maintain the relative value of each case mix index (CMI) while achieving congruence on overall SNF paym
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Hereâs an unusual question about vaccine registration: How does a person get off the state list?
Thomas Balch of Fredericksburg and two family members, all over age 65, signed up through the Rappahannock Area Health District website in January, then successfully got appointments through Mary Washington Healthcare during the brief period it scheduled them through its website. While MWHC workers and volunteers continue to vaccinate people at the Fick Conference Center, the health care system isnât creating a separate list anymore. All names come from the local health district.
Balch is concerned that he and his family membersâand others who did the same dual enrollmentâmight be âcluttering up the waiting list.â He wondered if he could remove their names so they donât delay others from getting appointments or cause an âadministrative burdenâ for workers.