The Centers for Medicare and Medicaid Services (CMS) released a pair of proposed rules on April 27, 2023 that make substantial changes to the structure of Medicaid and the Children’s Health Insurance Program (CHIP), both in the traditional fee-for-service setting
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.
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A Potential Route to RADV Judicial Review: Part III
In part I, we discussed whether federal district courts could exercise jurisdiction under the federal-question statute over legal challenges to overpayment determinations made by the Centers for Medicare & Medicaid Services (CMS) under the agency’s controversial Risk Adjustment Data…
DACA Recipients Can Enroll in Qualified Health Plans under Proposed HHS Rule
The Department of Health and Human Services (HHS) has issued a notice of proposed rulemaking that removes an exception to the definition of “lawfully present” that would then serve to include in that term individuals who have obtained temporary immigration…
HHS Proposes Bridge Access Program for COVID-19 Vaccines and Treatments
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 following the end of the Public Health Emergency on May 11, 2023. The “HHS Bridge Access…
Proposed changes to HIPAA highlight increased demands for third party access to reproductive health data
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 (NPRM) to modify the HIPAA Privacy Rule to address the release of reproductive health care information…
New Opportunities, New Challenges: FDA Elaborates on use of Digital Health in Drug and Biological Product Development
Note: This is Part 1 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…
A Potential Route to RADV Judicial Review: Part II
In part I, we discussed whether federal district courts could exercise jurisdiction under the federal-question statute over legal challenges to overpayment determinations made by the Centers for Medicare & Medicaid Services (CMS) under the agency’s controversial Risk Adjustment Data…
OIG approves lab company’s gift card proposal for colorectal cancer screening kits
By Smita Patil
On March 24, 2023, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued an advisory opinion in response to a proposal by a laboratory test kit company to provide prepaid gift cards to individuals, including federal…
Reed Smith’s Ninth Annual Washington Health Care Conference is Here!
Taking a quick break from your regularly scheduled health policy and litigation analysis to let you know, if you want to get some of this analysis in person straight from the authors of this blog (along with CLE credit!), we…
A Potential Route to RADV Judicial Review: Part I
The Medicare Act does not expressly provide for judicial review of overpayment determinations made by the Centers for Medicare & Medicaid Services (CMS) under the agency’s controversial Risk Adjustment Data Validation (RADV) program for Medicare Advantage (MA) organizations. With the…