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Comment Period Proposed Rules Healthcare

McDermott Will & Schulte

CMS proposes RPM reimbursement updates, requests information on reimbursing for SaaS

Over the past several years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to recognize and pay for non-face-to-face services that improve care management...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

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

Latham & Watkins LLP on

The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more

Holland & Knight LLP

CMS Releases CY 2026 Outpatient Prospective, ASC Payment System Proposed Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on July 15, 2025, issued the Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems proposed rule, which proposes updates to the...more

Polsinelli

CMS Issues Request for Public Input on Hospital Pricing Transparency

Polsinelli on

Key Takeaways - 1. Centers for Medicare & Medicaid Services (CMS) Aims to Strengthen Enforcement - The agency is evaluating how to better enforce hospital price transparency rules under the Executive Order....more

Sheppard Mullin Richter & Hampton LLP

CMS Proposes Medicare Payment Policies for Hospital Inpatient Services for Federal Fiscal Year 2026

The Centers for Medicare & Medicaid Services (CMS) recently published the fiscal year (“FY”) 2026 proposed rule for Hospital Inpatient Prospective Payment Systems (IPPS) (the “Proposed Rule”). Comments to the Proposed Rule...more

Vorys, Sater, Seymour and Pease LLP

Proposed Update to the HIPAA Security Rule

In early January, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a Notice of Proposed Rulemaking. The Proposed Rule would modify the Security Standards for the Protection of...more

Bass, Berry & Sims PLC

CMS CY 2026 Parts C and D Proposals Focus on Informed Choice

Bass, Berry & Sims PLC on

On December 10, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule, which, if finalized as proposed, has potentially significant implications for Medicare Advantage (MA) plans and Medicare...more

DLA Piper

CMS Releases New Proposed Rule for Medicare Advantage and Part D

DLA Piper on

On December 10, 2024, the Centers for Medicare and Medicaid Services (CMS) released a Proposed Rule for revisions to the regulations governing the Medicare Advantage (MA) program, Medicare Prescription Benefit (Part D),...more

McDermott Will & Schulte

DOJ Proposes Restrictions on Transactions Involving Bulk Sensitive Data

McDermott Will & Schulte on

On October 29, 2024, the US Department of Justice (DOJ) issued a proposed rule to implement US President Joe Biden’s Executive Order (EO) 14117 aimed at preventing access to Americans’ sensitive personal data and...more

Sheppard Mullin Richter & Hampton LLP

Comment Period for the No Surprises Act Proposed Rule, “Federal Independent Dispute Resolution (IDR) Operations,” Will Reopen

On January 17, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively, the “Departments”) and the Office of Personnel Management issued a notice that they will reopen the period for...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Foley Hoag LLP

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply to Laboratory Developed...

Foley Hoag LLP on

FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of IVDs in 21 CFR § 809.3 to...more

Nelson Mullins Riley & Scarborough LLP

FDA Proposes Drastic Overhaul of Laboratory Developed Test Regulation

Of particular interest to clinical laboratories and medical device manufacturers, the U.S. Food and Drug Administration (FDA or the Agency) released a controversial proposed rule on September 29 that would dramatically alter...more

Troutman Pepper Locke

Another Critical Item for Long-Term Care Facilities to Add to Their To-Do List — New Staffing Mandates

Troutman Pepper Locke on

On September 1, the Centers for Medicare & Medicaid Services (CMS) released the Minimum Staffing Standards for Long-Term Care (LTC) Facilities and Medicaid Institutional Payment Transparency Reporting proposed rule. This...more

Polsinelli

CMS Proposes Changes to Medicare Provider Enrollment Rules

Polsinelli on

The Centers for Medicare & Medicaid Services (“CMS”) published proposed changes to the Medicare Provider Enrollment requirements in the 2024 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”). If finalized,...more

McDermott Will & Schulte

Remote Monitoring: CMS Clarifies Guidance, Proposes Rural Provider Payment, Requests Information on Digital Therapeutics

Over the past several years, the Centers for Medicare and Medicaid Services (CMS) has expanded payment for care management and remote monitoring services in an effort to recognize and pay for non-face-to-face services that...more

Nelson Mullins Riley & Scarborough LLP

Hospital Price Transparency Changes in the Calendar Year 2024 Hospital Outpatient Prospective Payment System Proposed Rule

As part of the Calendar Year 2024 Outpatient Prospective Payment System and Ambulatory Surgical Center Proposed Rule issued on July 13, 2023, the Centers for Medicare and Medicaid Services (CMS) proposed changes to the...more

Polsinelli

“36-Month Rule” Anticipated to Expand to Hospice

Polsinelli on

On July 10, the Centers for Medicare & Medicaid Services (“CMS”) issued a Proposed Rule that would extend the “36-Month Rule” to Hospice providers. The 36-Month Rule refers to 42 C.F.R. § 424.550(b), which currently...more

McDermott+

End-Stage Renal Disease Prospective Payment System CY 2024 Rule Update

McDermott+ on

On June 26, 2023, the Centers for Medicare & Medicaid Services (CMS) released the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Calendar Year (CY) 2024 Proposed Rule (CMS-1782-P). The proposed rule would...more

Epstein Becker & Green

HHS Proposes Amendments to HIPAA that Protect Reproductive Health Care Information in Wake of Dobbs

Epstein Becker & Green on

Introduction - Following the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization overturning Roe v. Wade, the federal government, pursuant to President Biden’s Executive Order (the EO) took several steps...more

Nossaman LLP

CMS Attempts to Reduce Appointment Times for Medicaid and CHIP Patients - How Will This Impact Your Managed Care Plan?

Nossaman LLP on

A recent survey found that the average wait time for a new patient to see a physician in 15 of the largest cities in the U.S. was 26 days, up from 24.1 days in 2017.  Timely access to health care providers has long been an...more

Akerman LLP - Health Law Rx

OCR’s Proposed Rule Finds Fertile Ground for Enhanced Reproductive Privacy Protection

The Department of Health and Human Services Office for Civil Rights (OCR) issued a proposed rule on April 17, 2023, to amend provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to strengthen...more

Polsinelli

HIPAA Notice of Proposed Rulemaking on Reproductive Health Care Privacy

Polsinelli on

On April 12, 2023, the Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“Notice” or “NPRM”) to solicit comments on proposed modifications to the HIPAA...more

Robinson+Cole Health Law Diagnosis

HHS Seeks to Strengthen Protections of Confidential Reproductive Health Information with Proposed Changes to HIPAA

On April 12, 2023, the U.S. Department of Health & Human Services (HHS) released a Notice of Proposed Rulemaking (Proposed Rule) that seeks to enhance safeguards of reproductive health care information through changes to the...more

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