On June 6, 2023, the Center for Medicare and Medicaid Services (“CMS”) released a Quality Safety & Oversight memorandum (“QSO Memo”) reminding state survey agencies, accrediting organizations, and hospitals of the requirements for discharges and transfers to post-acute care (“PAC”)
Health Industry Washington Watch
Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry
Health Industry Washington Watch, published by Reed Smith LLP, focuses on legal and regulatory developments affecting the healthcare and life sciences sectors. The blog covers topics such as Medicare and Medicaid policy changes, pharmacy benefit management reforms, healthcare provider compliance, life sciences transactional and litigation issues, product liability directives, and emerging trends in healthcare fraud and abuse enforcement. It also addresses the impact of new laws on healthcare ownership and investment, telehealth supervision rules, and evolving legal challenges in areas like vaccine liability and women’s health. The content is aimed at healthcare providers, payers, manufacturers, and legal professionals navigating complex healthcare regulations and industry shifts.
Latest from Health Industry Washington Watch - Page 12
DEA Adds Second Step to Reporting Procedure for Controlled Substance Theft or Loss
The Drug Enforcement Administration (DEA) has published a new final rule regarding reporting of theft or significant loss of controlled substances. Through the final rule, the DEA amended the existing regulations governing the form and timing used to formally report…
Patient access and big-ticket data breaches lead OCR enforcement initiatives
HIPAA enforcement actions in the past year have continued to focus on the patient right to access initiative and large scale data breaches. While most of the recent enforcement actions focused on the patient right to access initiative, two noteworthy…
HIPAA Privacy Rule commenters express concerns about privacy, health outcomes, LQBTQIA+ rights, and historical health care disparities
The comment period for the U.S. Department of Health and Human Services Office for Civil Rights (OCR proposed changes to Privacy Rule ended on June 16, 2023, and the first portion of comments have been released to the public. As…
FDA Issues Draft Guidance on Good Clinical Practice in Ongoing Clinical Trial Modernization Efforts
Note: This is Part 2 in a series of blog posts on developments from the U.S. Food and Drug Administration (“FDA”) regarding its commitments set forth under the Prescription Drug Under Fee Act Reauthorization Performance Goals and Clinical Trial Diversity…
CMS Withdraws Health Care Staff Vaccination Requirements
Almost two years after issuing its Interim Final Rule requiring COVID-19 vaccination for certain health care works, the Centers for Medicare and Medicaid Services (“CMS”) has issued a final rule addressing several regulations regarding COVID-19 vaccination, testing, and education requirements…
HHS Amends and Extends COVID-19 PREP Act Declaration
By Megan K. Ali
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 Eleventh Amendment to the declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for…
New York Passes Health Care Transaction Notice Requirements
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 Department of Health (DOH) providing information about any material transaction involving that health care entity.…
OIG announces Modernization of Compliance Program Guidance
On April 24, 2023, the OIG formally announced that it will be modernizing its existing Compliance Program Guidance (“CPG”).
The OIG has provided a CPG for various industry subsections since 1998. Each CPG was developed in an effort to set…
OIG Approves Charity’s Modifications to Plan to Purchase and Forgive Medical Debt
On April 24, 2023, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a modification to advisory opinion 20-04, from July 2020, where the OIG opined favorably on the proposal to purchase or receive donations of…