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FTC Finalizes Amendments to Health Breach Notification Rule Aimed at Clarifying its Application to Health Applications and Similar...

On April 26, 2024, the Federal Trade Commission (FTC) released a pre-publication version of its final changes to the Health Breach Notification Rule (HBNR) designed to clarify the scope of the HBNR, including its coverage of...more

CMS Issues Final Rule Aimed at Improving Prior Authorization Processes

On January 18, 2024, CMS released a pre-publication version of a final rule (the Final Rule) that will require Medicare Advantage organizations (MA or Part C), Medicaid and the Children’s Health Insurance Program (CHIP)...more

CMS Proposes Changes to the Medicare Advantage and Part D Programs Aimed at Improving Beneficiary Protections, Access to Care, and...

On November 6, 2023, CMS released a pre-publication version of a proposed rule (Proposed Rule) that is set to publish in the Federal Register on November 15, 2023, and that would amend the regulations governing Medicare...more

HRSA Ends PHE Waivers, Requiring Hospitals to Register Off-Site Outpatient Facilities for 340B Program

On October 27, 2023, the Health Resources and Services Administration of HHS (HRSA) issued a Federal Register Notice (the Notice) requiring hospitals to register their off-site outpatient facilities to continue participating...more

CMS Issues Draft Guidance for Implementing Medicare Prescription Payment Plan for 2025

On August 21, 2023, CMS issued the first of two draft guidance documents for implementing the Medicare Prescription Payment Plan that was established by section 11202 of the Inflation Reduction Act (IRA) and signed into law...more

OCR and FTC Issue Letter to Hospital Systems and Telehealth Providers Emphasizing Privacy and Security Risks Related to Online...

On July 20, 2023, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and the Federal Trade Commission (FTC) sent a letter to approximately 130 hospital systems and telehealth providers warning that...more

OIG Issues Favorable Opinion Regarding Pharmaceutical Company’s Free 14-Day Drug Supply to Patients Experiencing a Delay in...

On February 28, 2023, OIG posted Advisory Opinion 23-02, responding to a request by a pharmaceutical company (the Company) regarding its proposal to offer a free 14-day supply of an enzyme replacement therapy drug to patients...more

FTC Proposes Enforcement Action Prohibiting GoodRx from Disclosing Users’ Health Information for Advertising

On February 1, 2023, the Federal Trade Commission (FTC) announced that it has taken enforcement action for the first time under its Health Breach Notification Rule (HBNR) against GoodRx Holdings Inc. (GoodRx), for allegedly...more

OIG Recommends CMS Use OIG Hospital Compliance Audits to Enhance its Medicare Oversight

On October 26, 2022, OIG published a report summarizing the results of 12 OIG hospital compliance audits covering Medicare claims paid from 2016 through 2018. OIG recommends, among other things, that CMS follow up on...more

CMS Issues Three Payment Rules for FY 2023

On July 27, 2022, CMS issued final rules for FY 2023 in its yearly update to Medicare payment policies and rates under the Inpatient Rehabilitation Facilities (IRFs) prospective payment system (PPS) and the Inpatient...more

CMS Issues CY 2023 Physician Fee Schedule Proposed Rule

On July 7, 2022, CMS released the Calendar Year (CY) 2023 Physician Fee Schedule (PFS) proposed rule (the Proposed Rule). The Proposed Rule includes proposed policy changes for Medicare payments under the Physician Fee...more

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