Updates by Reed Smith on U.S legislative and regulatory developments affecting the life sciences and health care industry sector.
Articles: 1-10 of 1052
HHS Amends and Extends COVID-19 PREP Act Declaration
USA - May 24 2023 Earlier this month, in response to the end of the COVID-19 public health emergency, the Department of Health and Human Services (“HHS”) issued the…
New York Passes Health Care Transaction Notice Requirements
USA - May 8 2023 On May 3, New York Governor Kathy Hochul signed into law provisions that will require health care entities to submit a notification to the state…
OIG announces Modernization of Compliance Program Guidance
USA - May 2 2023 On April 24, 2023, the OIG formally announced that it will be modernizing its existing Compliance Program Guidance (“CPG”). The OIG has provided a…
OIG Approves Charity’s Modifications to Plan to Purchase and Forgive Medical Debt
USA - May 1 2023 On April 24, 2023, the Department of Health and Human Services' Office of Inspector General ("OIG") issued a modification to Advisory Opinion 20-04…
CMS proposes Medicaid changes that are likely to have significant impact on beneficiaries and Medicaid MCO payments
USA - April 28 2023 The Centers for Medicare and Medicaid Services (CMS) released a pair of proposed rules on April 27, 2023 that make substantial changes to the…
A Potential Route to RADV Judicial Review: Part III
USA - April 27 2023 In part I, we discussed whether federal district courts could exercise jurisdiction under the federal-question statute over legal challenges to…
DACA Recipients Can Enroll in Qualified Health Plans under Proposed HHS Rule
USA - April 26 2023 The Department of Health and Human Services (HHS) has issued a notice of proposed rulemaking that removes an exception to the definition of “lawfully…
HHS Proposes Bridge Access Program for COVID-19 Vaccines and Treatments
USA - April 25 2023 On April 18, 2023, the U.S. Department of Health and Human Services (“HHS”) announced its plan to maintain access to COVID-19 vaccines and treatment…
Proposed changes to HIPAA highlight increased demands for third party access to reproductive health data
USA - April 24 2023 On Monday, April 12, 2023, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued a notice of proposed rulemaking…
New Opportunities, New Challenges: FDA Elaborates on use of Digital Health in Drug and Biological Product Development
USA - April 21 2023 The Food and Drug Omnibus Reform Act of 2022 (FDORA) signed by President Biden on December 29, 2022, introduced significant changes to the way in…
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