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HHS Modifies HIPAA Privacy Rule to Shield Reproductive Health Information from Third Party Access
In a final rule published on April 26, the U.S. Department of Health and Human Services (“HHS”) amends the HIPAA Privacy Rule to bolster protections for individuals’ reproductive health inf...
Are you listening, Medicare Advantage and Medicare Part D Plans? It’s CMS (Again)
Making good on its promises to enhance oversight of Medicare Advantage (MA) and Medicare Part D plans, the Centers for Medicare and Medicaid Services (CMS) has submitted for public inspection its...
FTC, HHS, and DOJ Launch Portal to Report Anticompetitive Health Care Practices
Last week, on April 18, several federal agencies jointly launched a “one-stop shop” to facilitate reporting of allegedly anticompetitive behavior in the health care sector. While there has al...
CMS Offers Change Healthcare/Optum Payment Disruption Payments to Medicare Providers and Suppliers
On March 9, 2024, in response to the cyberattack on UnitedHealth Group’s subsidiary, Change Healthcare/Optum, in late February 2024, the Centers for Medicare & Medicaid Services (“CMS”) mad...
FDA Proposed Rule Establishes Criteria for Difficult Drugs to Compound Under Sections 503A and 503B
The United States Food and Drug Administration (FDA) has proposed a rule on “Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under sections 5...
SCOTUS Arguments on Mifepristone Cases Focus on Standing and Remedy
The U.S. Supreme Court heard arguments yesterday in the two consolidated cases challenging the U.S. Food and Drug Administration (FDA) approval of mifepristone. Throughout the questioning, the Ju...
States’ legislative reaction to Dobbs impacts consumer health data privacy
In the two years since the Dobbs v. Jackson Women’s Health decision from the Supreme Court, state legislatures and courts have attempted to define the new post-Roe landscape in health care. Tha...
Was the Consolidated Appropriations Act, 2023 Legitimately Passed by the House?
Not a question that we thought we would be asking more than a year after the large omnibus package was signed into law by President Biden. But here we are, with a federal judge in Texas ruling on...
Antitrust and Health Care Fraud Enforcers Launch Inquiry into Private Equity Ownership in Health Care
The Federal Trade Commission (FTC), the Department of Justice’s Antitrust Division, and the U.S. Department of Health and Human Services jointly announced a cross-government inquiry into the im...
DOJ Announces $2.7 Billion in FCA Recoveries and Enforcement Priorities
The Department of Justice (DOJ) reported that its False Claims Act (FCA) recoveries for civil cases raked in approximately $2.7 billion for fiscal year 2023, representing a $450 million jump from...