The Preventative Care Management Program (PCMP) is a workplace initiative aimed at enhancing employee benefit packages through a wellness program. This program is engineered to comply with regulatory standards and offers valuable wellness and supplemental benefits to employees while simultaneously helping employers lower payroll taxes (source: PCMP Program, Tax-Efficient Group).

Eligible participants for the PCMP must be full-time employees on W-2 forms who have major medical coverage. Freelance or part-time employees are not qualified for this program (source: Tax-Efficient Group, Sure Advisors). The PCMP is designed to provide added wellness benefits without increasing out-of-pocket costs for employers, ultimately supporting employee health and well-being (source: Open Advisor).

As for the eligibility of HXT products under the PCMP's regulatory framework with the FDA, there are specific guidelines and requirements for establishments working with human cells, tissues, and cellular and tissue-based products (HCT/Ps). Establishments must register their HCT/Ps within five days of beginning operations, with annual updates required (source: FDA Tissue Establishment Registration). Adherence to the regulations set out in Title 21 CFR Part 1271 and compliance guidelines is vital for establishments in the sector (source: FDA Small Entity Compliance Guide).

In summary, the PCMP is designed to enhance workplace wellness while complying with regulatory requirements, and although there are specific eligibility criteria for employees under the PCMP, facilities dealing with HXT must also navigate FDA registration and eligibility aspects.

Sources

PCMP PROGRAMPreventative Care Management Program | Tax-Efficient GroupPreventative Care Management Program - Why Sure Advisors?Tissue Establishment Registration - FDAPreventative Care Management Program - Open AdvisorEverything You Need to Know About the Attentive Preventative Care ...Regulation of HCT/Ps - Small Entity Compliance Guide - FDA

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