News & Analysis as of

Comment Period Healthcare Reform Proposed Rules

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

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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

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

DLA Piper

CMS Releases New Proposed Rule for Medicare Advantage and Part D

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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 & Emery

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

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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

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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

Epstein Becker & Green

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

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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?

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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

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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

Polsinelli

Telehealth: CMS Proposes to Discontinue Audio-Only E/M Services and Virtual Direct Supervision in 2023 Proposed Rule

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On July 07, 2022 the Centers for Medicare and Medicaid Services (“CMS”) released the 2023 Physician Fee Schedule (“PFS”) Proposed Rule, which proposes several significant changes to Medicare telehealth services....more

Quarles & Brady LLP

Hot Off the Press: Mississippi Board of Pharmacy Files Proposed Rule on Shared Pharmacy Services

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On June 10, 2022, the Mississippi Board of Pharmacy filed their much-anticipated proposed rule on pharmacy shared services, starting the clock on the 25-day public comment period. The Board simultaneously filed its...more

Ballard Spahr LLP

Health Care and Price Transparency: The Latest Summary

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Federal executive agencies recently published two rules, one final and one proposed, aimed at publicizing the various costs associated with health care. A final rule, promulgated by the Department of Health and Human Services...more

McDermott Will & Emery

Stark Law and Anti-Kickback Statute Proposed Rules Would Facilitate Donations of EHR and Cybersecurity Technology and Services

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On October 17, 2019, the Department of Health & Human Services (HHS) published proposed rules in the Federal Register that would amend existing and create new exceptions to the physician self-referral law (Stark Law) and safe...more

Seyfarth Shaw LLP

New Safe Harbors In A Storm of Risk and Regulations: A Review of the OIG’s Proposed Changes to the Federal Anti-Kickback Laws

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In an effort to modernize and clarify a statute that looms large in the minds of health care providers across the nation, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) recently...more

Bricker Graydon LLP

OIG proposes changes to existing Anti-Kickback Statute safe harbors

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On October 9, 2019, the Office of Inspector General (OIG) released proposed changes interpreting the federal Anti-Kickback Statute (AKS) and its regulatory safe harbors, including changes to several existing safe harbors. ...more

Foley Hoag LLP - Medicaid and the Law

CMS Medicaid Fiscal Accountability Regulation Published

Earlier this week, CMS released for publication a proposed rule that would add some degree of transparency and oversight to the somewhat opaque world of Medicaid financing. It’s a topic that’s fascinated us here at the...more

Polsinelli

Assessing the Stark and Anti-Kickback Proposals for Value-Based Arrangements

Polsinelli on

Through two separate notices of proposed rule-making (NPRMs), the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG), seek to remove...more

Robinson+Cole Health Law Diagnosis

CMS Proposes to Newly Define Commercially Reasonable, and Tweak Definition of Fair Market Value, in New Physician Self-Referral...

On October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) formally published its proposed rule (the PSR Rule) to update exceptions to the Physician Self-Referral Law (PSR Law, also known as the Stark Law). For...more

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 3: CMS Proposes Expansive Set of Changes to Stark Regulations

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This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part...more

Robinson+Cole Health Law Diagnosis

CMS Proposes Rule Clarifying Physician Self-Referral Law Rules for Group Practice Profit Sharing

On October 9, 2019 the Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published a proposed rule making changes to the Physician Self-Referral Law, also called the Stark Law (PSR...more

Robinson+Cole Health Law Diagnosis

HHS Proposes Changes to Permit Donation of Cybersecurity Technology

On October 17, 2019, the Department of Health and Human Services (HHS) published proposed rules to update the regulatory Anti-Kickback Statute (AKS) safe-harbors and exceptions to the Physician Self-Referral (PSR) Law, known...more

McDermott Will & Emery

Stark Law Proposed Change Affects Group Practice Special Rules for Productivity Bonuses, Profit Shares

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On October 9, 2019, the US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published proposed changes to the physician self-referral law (Stark Law). Physician practices are subject to...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records

On October 17, 2019, the Department of Health & Human Services (HHS) published two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if...more

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