News & Analysis as of

Health Care Providers Comment Period

Benesch

CMS Proposes Comprehensive Updates to Remote Patient Monitoring and Remote Therapeutic Monitoring Reimbursement

Benesch on

On July 14, 2025, the Centers for Medicare & Medicaid Services (“CMS”) issued the CY 2026 Medicare Physician Fee Schedule (“PFS”) Proposed Rule. Published in the Federal Register on July 16, 2025, the rule outlines...more

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

Husch Blackwell LLP on

On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Benesch

CMS Proposes Overhaul of Skin Substitute Reimbursement Policy Beginning January 2026 - Implications for Providers, Manufacturers,...

Benesch on

On July 16, 2025, the U.S. Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) published its CY 2026 Medicare Physician Fee Schedule (PFS) Proposed Rule, which includes a sweeping...more

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

Shipman & Goodwin LLP on

On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

Tucker Arensberg, P.C.

CMS Unveils 2026 Physician Fee Schedule Proposal: Key Changes Ahead

Tucker Arensberg, P.C. on

On July 14, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2026 Physician Fee Schedule. As expected, there are several meaningful updates that providers, practices, and health systems...more

Foley & Lardner LLP

HHS Guidance Excluding Non-Qualified Aliens from More Federal Programs Raises Questions for Providers and Grantees

Foley & Lardner LLP on

A Notice published on July 14, 2025 identifies 12 new Federal public benefit programs (see list below) for which non-qualified aliens are not eligible. Although it was published by the U.S. Department of Health and Human...more

Holland & Knight LLP

CMS Releases CY 2026 Medicare Physician Fee Schedule Proposed Rule

Holland & Knight LLP on

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

Foley & Lardner LLP on

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

Fenwick & West LLP on

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

Fisher Phillips on

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

Holland & Knight LLP on

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

Fox Rothschild LLP on

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

McDermott+ on

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 & Schulte

CMS Revives, Expands Proposed Changes to Medicare Overpayment Rule

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

Holland & Knight LLP on

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

Holland & Knight LLP on

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

McDermott+ on

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

Burr & Forman on

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

McDermott+ on

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

Epstein Becker & Green on

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

Mayer Brown on

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

Williams Mullen on

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

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