News & Analysis as of

Medicare Regulatory Requirements

Orrick, Herrington & Sutcliffe LLP

Opportunities and Risks in Remote Patient Monitoring and Remote Therapeutic Monitoring for 2026

The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule (see Orrick’s analysis of the proposed rule here) contains important signals for the future of remote patient monitoring (RPM) and remote therapeutic...more

Foley & Lardner LLP

Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM): What You Need to Know About CMS’ Proposed Changes

Foley & Lardner LLP on

On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) proposed key changes to remote patient monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare program. The...more

Mintz - Health Care Viewpoints

CMS Proposes New Standards for Bona Fide Service Fees in Average Sales Price Calculations: What Plans, PBMs, and Other Recipients...

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...more

Tucker Arensberg, P.C.

CMS Unveils 2026 Physician Fee Schedule Proposal: Key Changes Ahead

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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

Ropes & Gray LLP

Proposed Changes to Medicare Payment Rules: What Life Sciences Companies Need to Know

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The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more

King & Spalding

The One Big Beautiful Bill Act Explained: A Detailed Review of Key Changes for the Healthcare Industry

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To offset the cost of other provisions in the bill, the One Big Beautiful Bill Act (OBBBA) includes significant reforms to Medicaid, Medicare, and Affordable Care Act (ACA) premium tax credits that are expected to result in...more

Mintz - Health Care Viewpoints

WISeR Model Will Test the Use of Artificial Intelligence for Prior Authorization in Medicare: Key Considerations for Health Care...

The Center for Medicare and Medicaid Innovation (CMMI) recently announced a six-year payment model for 2026-2031 called the Wasteful and Inappropriate Service Reduction (WISeR) Model. WISeR will test the use of artificial...more

Blank Rome LLP

Impact of Recent CMS Rule on Site Neutrality and 340B Programs—Implications for Oncology Services

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Overview - The Centers for Medicare & Medicaid Services (“CMS”) has finalized and proposed several significant changes affecting both site neutrality in Medicare payments and the 340B Drug Pricing Program. These changes...more

Foley & Lardner LLP

Update: CMS Extends Skilled Nursing Facilities’ Medicare Revalidation Deadline

Foley & Lardner LLP on

On July 17, 2025, the Centers for Medicare and Medicaid Services (CMS) announced an additional extension of the deadline by which skilled nursing facilities (SNFs) must revalidate their Medicare enrollments. Enrolled SNFs...more

McDermott+

Site neutrality is on the menu in the CY 2026 Medicare Outpatient Prospective Payment System proposed rule

McDermott+ on

Last week, the Centers for Medicare & Medicaid Services (CMS) issued two major regs: the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) proposed rule and the CY 2026 Outpatient Prospective Payment System (OPPS)...more

Arnall Golden Gregory LLP

SNF Off-Cycle CMS-855A Reporting Delayed to January 1, 2026

The Centers for Medicare & Medicaid Services (“CMS”) has extended the window for skilled nursing facilities (“SNFs”) to file off-cycle Medicare revalidation documents until January 1, 2026. This marks CMS’ third deadline...more

WilmerHale

2024 CMS Audit and Enforcement Report

WilmerHale on

On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released an Audit and Enforcement Report summarizing its annual Medicare Advantage (Part C) and Prescription Drug (Part D) program audits and enforcement...more

Hogan Lovells

Medicare proposed rules include government pricing surprises: ASP changes and maximum fair price, new bona fide service fee and...

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Every July, the Centers for Medicare & Medicaid Services (CMS) publishes two proposed rules relating to how it plans to administer the Medicare Part B program for the next calendar year: the physician fee schedule (PFS)...more

Benesch

Off-Cycle Medicare Revalidations for SNFs – Deadline Extended Again to January 1, 2026

Benesch on

On July 17, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced via a Medicare Learning Network (“MLN”) update that the deadline for submission of mandatory off-cycle Medicare revalidations...more

DLA Piper

Proposed CY 2026 Medicare Physician Fee Schedule: Key Changes Impacting the Medicare Shared Savings Program

DLA Piper on

On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) released the 2026 calendar year (CY 2026) Medicare Physician Fee Schedule (Proposed Rule). Among the many changes proposed, the Proposed Rule includes...more

McDermott+

CMS releases CY 2026 Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System proposed rule

McDermott+ on

On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule [CMS-1834-P],...more

Benesch

CMS’s CY 2026 Fee Schedule Proposal: MSSP Reforms Take Center Stage in Push Toward Value

Benesch on

On July 14, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the proposed rule for the Calendar Year (“CY”) 2026 Medicare Physician Fee Schedule (“PFS”), formally titled CMS-1832-P....more

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

Husch Blackwell LLP on

In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Bond Schoeneck & King PLLC

CMS Delays Deadline for Nursing Home Federal Disclosures – August 1, 2025, Has Become January 1, 2026: Consider Support from Bond...

The Centers for Medicare and Medicaid Services (“CMS”) will be extending the deadline for the mandatory off-cycle revalidation process for Medicare-certified skilled nursing facilities (SNFs). The revised deadline is Jan. 1,...more

Hendershot Cowart P.C.

Qlarant, Novitas Audits Escalate as Medicare Skin Substitutes Spending Hits $1.6 Billion, CMS Seeks Evidence of Clinical...

Hendershot Cowart P.C. on

The wound care industry faces unprecedented scrutiny as Medicare Part B expenditures for skin substitutes exceeded $1.6 billion in the fourth quarter of 2023 alone. The spending surge has triggered a wave of skin substitute...more

Polsinelli

CMS Proposes New Mandatory, Two-Sided Risk Model for Heart Failure and Low Back Pain

Polsinelli on

Key Takeaways - CMS has proposed a mandatory two-sided risk model for specialists treating heart failure and low back pain in outpatient settings....more

Benesch

Dialysis & Nephrology Digest - July 2025

Benesch on

CMS Releases Proposed Rule for 2026 ESRD PPS - As the nephrology organization representing the specialty on socioeconomic and physician practice issues, the Renal Physicians Association analyzes and disseminates...more

McDermott+

Digesting a giant reg: the CY 2026 Medicare Physician Fee Schedule proposed rule

McDermott+ on

Earlier this week, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) proposed reg. Stakeholders have highly anticipated the release of this reg, as it...more

King & Spalding

CMS Escalates Aggressive Rates Cut in Home Health Prospective Payment System Proposed Rule for CY 2026

King & Spalding on

On June 30, 2025, CMS issued its annual Home Health Prospective Payment System Proposed Rule for Calendar Year (CY) 2026 (the Proposed Rule). The Proposed Rule continues the agency’s policy of using provisions of the...more

Arnall Golden Gregory LLP

CMS Announces Changes for SNFs on Care Compare Website

The Centers for Medicare & Medicaid Services (“CMS”), Center for Clinical Standards and Quality recently announced upcoming changes to skilled nursing facility (“SNF”) profiles on the Medicare Care Compare website. Care...more

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