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Holland & Knight LLP

CMS Releases CY 2026 Medicare Physician Fee Schedule Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) on July 14, 2025, issued the calendar year (CY) 2026 Proposed Rule, which proposes payment policies and other outpatient services covered under Medicare Part B. Comments are...more

Foley & Lardner LLP

DEA Buprenorphine Rule Delayed to December 31, 2025

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The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final...more

Fenwick & West LLP

Understanding the DEA’s New Telemedicine Rules: FAQ for Healthcare Providers and Telehealth Companies

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The U.S. Drug Enforcement Administration (DEA) recently announced new rules that will impact telemedicine practices, especially concerning remote prescribing of controlled substances....more

Fisher Phillips

Proposed Updates to HIPAA Security Rule Would Require Entities to Adopt Enhanced Cybersecurity Measures

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The HIPAA Security Rule may soon undergo a big overhaul that would better defend healthcare data from cybersecurity threats – and require much more from covered entities when it comes to establishing and maintaining defenses....more

Holland & Knight LLP

Big Changes Proposed for the HIPAA Security Rule

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The U.S. Department of Health and Human Services (HHS) has issued an unpublished Notice of Proposed Rulemaking (NPRM) that strengthens the Health Insurance Portability and Accountability Act (HIPAA) Security Rule and, if...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Affordable Care Act Proposed Rule Would Broaden Access to Over-the-Counter Contraception Without Cost Sharing

Employer-sponsored health plans would be required to cover over-the-counter contraception, including condoms and emergency contraception, without a prescription and without cost sharing under newly proposed Affordable Care...more

Fox Rothschild LLP

CMS Proposed Rule Decreases Physician Payments, Expands Telehealth, and Much More

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The comment period for the CMS CY 2025 Physician Fee Schedule (PFS) Proposed Rule recently closed on Monday, September 9th. Based on previous years, the Final Rule can be expected as soon as early November, taking effect...more

McDermott+

Responses to the PFS Proposed Reg Are In: 10 Major Comments

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McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. September 19, 2024 – Comments on the calendar year (CY) 2025 physician fee...more

McDermott Will & Emery

CMS Revives, Expands Proposed Changes to Medicare Overpayment Rule

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In response to comments on the 2022 proposed changes to the overpayments regulation, the Centers for Medicare & Medicaid Services (CMS) proposed additional changes to the overpayment rule to clarify that the obligation to...more

Bass, Berry & Sims PLC

CMS Solicits Comments to Clarify Parameters on MAC Downcoding of Complex Drug Administration Infusion Services

In the proposed CY 2025 Physician Fee Schedule (PFS) published in the Federal Register on July 31, the Centers for Medicare & Medicaid Services (CMS) is soliciting comments on a proposal to revise the Medicare Claims...more

Holland & Knight LLP

CMS Releases CY 2025 Medicare Physician Fee Schedule Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Revisions to Payment Policies Under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B (CMS-1807-P) Proposed...more

Holland & Knight LLP

CMS Releases CY 2025 OPPS and ASC Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1809-P),...more

Pullman & Comley - Connecticut Health Law

OHS Issues 2024 Statewide Health Care Facilities and Services Plan

The Connecticut Office of Health Strategy (OHS) has released the 2024 Statewide Health Care Facilities and Services Plan, along with a biennial inventory of all Connecticut health care facilities and services (the Plan)....more

McDermott+

Top 10 Comments on Proposed Mandatory Episode-Based Payment Model, TEAM

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Time’s up and pencils down! Public comments on the Centers for Medicare & Medicaid Services (CMS) Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) proposed regulation were due this past Monday, June 10, 2024. CMS...more

Burr & Forman

Proposed Revisions to Title II of the ADA Impacting Healthcare Facilities

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The Department of Justice recently published a notice of proposed rulemaking applicable to healthcare entities covered under Title II of the Americans with Disabilities Act that relates to accessibility to medical diagnostic...more

McDermott+

CMMI Proposes New Mandatory Episode-Based Payment Model

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Last week, the Centers for Medicare & Medicaid Services (CMS) released the Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) proposed regulation. This 1,900+ page annual reg updates Medicare payments and policies...more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

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Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

Mayer Brown

Private Equity in Healthcare: Increased Scrutiny from FTC, DOJ, and HHS

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Private equity acquisitions in healthcare will likely face increased scrutiny from multiple federal departments, as well as from state antitrust enforcement officials....more

Williams Mullen

42 CFR Part 2 Final Rule Harmonizes Substance Use Disorder Confidentiality Protections with HIPAA

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On February 8, 2024, the federal Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR Part 2 (Part 2) were revised in part to increase patient protection and streamline patient consent...more

Holland & Knight LLP

Holland & Knight Health Dose: February 6, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Goodwin

California OHCA Publishes Final Regulations Regarding Healthcare Transaction Filing Requirements and Review Process

Goodwin on

California Senate Bill 184 (SB 184), which was passed in June 2022, created the state Office of Health Care Affordability (OHCA) to contain healthcare spending in California.  Effective for transactions closing on or after...more

McDermott+

Stakeholders Request Changes to Proposed Information Blocking Disincentives for Healthcare Providers

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The public comments are in! The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) are now reviewing the 136 comments they received on a proposed...more

McDermott Will & Emery

Stark Law Changes for 2024: CMS Updates Designated Health Services Code List

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On November 29, 2023, the Centers for Medicare & Medicaid Services (CMS) published the 2024 annual update to the designated health services (DHS) Code List. This annual update includes important changes for Medicare providers...more

Jones Day

FDA Issues Revised Off-Label Communications Guidance

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The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more

Holland & Knight LLP

CMS Proposes Changes for Programs of All-Inclusive Care for the Elderly (PACE)

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The Centers for Medicare & Medicaid Services (CMS) recently proposed a rule that would change how organizations that participate in Programs of All-Inclusive Care for the Elderly (PACE) respond to complaints and address PACE...more

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