Health Care Law Brief
FEBRUARY 16, 2024
On February 6, 2024, the New York State Department of Financial Services (“DFS”) released “pre-proposed” consolidated rulemaking related to the business practices of Pharmacy Benefit Managers (“PBMs”) licensed to operate in New York. The draft regulations contemplate an enforcement date beginning July 1, 2025.
Innovaare Compliance
JANUARY 15, 2024
6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D. With a team of compliance specialists, Inovaare provides in-depth technical expertise and compliance preparedness evaluation, guidance, and support.
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Healthcare IT Today
JANUARY 5, 2023
Despite this, an organization’s flexibility and compliance with new regulations will help ensure success. The 2023 final Medicare Physician Fee Schedule (PFS) eased supervisory requirements for care delivered by a licensed professional counselor or licensed marriage and family therapist.
Healthcare IT Today
JANUARY 19, 2024
are expected to reach $6 trillion by 2027, cost containment and the push to increased decentralization of care will be a top healthcare priority in 2024. Legacy point solutions will be a thing of the past as we move to platforms that deliver more scalable solutions that allow healthcare providers to perform at the top of their licenses.
SQA
FEBRUARY 15, 2023
Additional details are provided with respect to the validity of certificates and “sell-off” periods. In FY 2022, the FDA issued 62 warning letters and 23 import alerts related to drugs, excluding compound related actions.
SQA
MAY 24, 2023
The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers. The written procedure for recall was inadequate and this procedure had not been implemented.
Healthcare Law Blog
AUGUST 25, 2022
Fifteen more Part D drugs are set to be published in 2027, followed by 15 Part D and Part B drugs, collectively, in 2028. With respect to biological products, however, such drugs must be licensed in accordance with the Public Health Service Act (“PHSA”) for at least 11 years, and marketed in conformance with the PHSA.
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