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Centers for Medicare & Medicaid Services (CMS) Proposed Rules Regulatory Requirements

Sheppard Mullin Richter & Hampton LLP

CMS Proposes to Amend Overpayment Rule-Questions Remain Regarding How the Rule Will be Implemented Should CMS Adopt the False...

On July 10, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule (“Proposed Rule”) in which it outlined proposed amendments to the suspension provisions and deadlines for reporting and returning...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

King & Spalding

CMS Issues Hospice Proposed Payment Rule

King & Spalding on

Last week, CMS issued a proposed rule (Proposed Rule) for fiscal year (FY) 2025 aiming to update Medicare hospice payments and aggregate cap amount in accordance with existing statutory and regulatory requirements. The...more

Jones Day

HHS Announces Upcoming Federal Strategies to Enhance Cybersecurity for Health Care and Public Health Sectors

Jones Day on

The Department of Health and Human Services ("HHS") has released a concept paper outlining its new cybersecurity strategies for the health care sector, identifying cybersecurity priorities, potential future regulations and...more

Davis Wright Tremaine LLP

HHS Proposes Information Blocking Disincentives for Health Care Providers

While health care providers have been required to comply with the 21st Century Cures Act Information Blocking Rule (the Rule) since April 5, 2021, as of yet there is no enforcement mechanism in place with respect to the Rule...more

McDermott+

McDermottPlus Check-Up: October 6, 2023

McDermott+ on

THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more

BakerHostetler

Stark and AKS Rules Cross the Finish Line of HHS Regulatory Sprint

BakerHostetler on

With a bold finish, the Department of Health and Human Services (HHS) crossed the finish line of its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark) and anti-kickback...more

Seyfarth Shaw LLP

OIG Releases Policy Statement Extending HHS Blanket Waiver Protection to Certain Federal Anti-Kickback Statute Violations During...

Seyfarth Shaw LLP on

On April 3, 2020, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a policy statement of enforcement discretion (the “Policy Statement”) regarding sanctions under the Federal...more

Jones Day

Newly Proposed AKS and Stark Law Protections For Value-Based Care Models

Jones Day on

The Situation: The Department of Health and Human Services has introduced the Regulatory Sprint to Coordinated Care Initiative in order to revise regulations associated with the anti-kickback statute, Stark Law, HIPAA, and 42...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...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

Seyfarth Shaw LLP on

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

Troutman Pepper

CMS Issues Controversial Health Care Pricing and Insurance Coverage Transparency Rules

Troutman Pepper on

On November 15, the Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring public disclosure of hospital charges. Along with the Departments of Health and Human Services, Labor and the Treasury, CMS...more

Tucker Arensberg, P.C.

Regulatory Sprint to Coordinated Care: New Stark & Anti-Kickback Rules

Tucker Arensberg, P.C. on

On October 22, 2019, CMS and OIG (Office of Inspector General) released new proposed rules regarding Stark Law Exceptions and Anti-Kickback Safe Harbors in response to what has universally been christened as the “Regulatory...more

Epstein Becker & Green

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

Epstein Becker & Green on

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

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 3: Personal Services and Management Contracts, Outcomes-Based Payments,...

This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the Anti-Kickback Statute (AKS) and the...more

Womble Bond Dickinson

Trump Administration’s ‘Regulatory Sprint’ Includes Revisions to Stark Law and Anti-Kickback Statute

Womble Bond Dickinson on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) released two proposed rules: Modernizing and Clarifying the Physician Self-Referral Regulations and Fraud and Abuse; Revisions to Safe Harbors under the...more

Katten Muchin Rosenman LLP

CMS Proposes Sweeping Revisions to the Stark Law

"CMS Proposes Sweeping Revisions to the Stark Law" is Part I of a two-part series discussing the US Department of Health and Human Services' (DHHS) recent proposed rules revising the Stark Law and the Anti-Kickback Statute as...more

Faegre Drinker Biddle & Reath LLP

New Stark Law Exceptions for Value-Based Care

On October 9, 2019, the U.S. Department of Health and Human Services released proposed changes to the Ethics in Patient Referrals Act (the “Stark Law”), as well as the Medicare and Medicaid Anti-Kickback Statute (the...more

Sheppard Mullin Richter & Hampton LLP

CMS and OIG Propose Regulatory Changes Impacting the Scope of the Stark Law and the Federal Health Care Program Anti-Kickback...

On October 9, 2019, the Department of Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”) released proposed rules in conjunction with HHS’ “Regulatory...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to Anti-Kickback Statute and Stark Law

On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued...more

McDermott Will & Emery

HHS Proposes Substantial Changes to Stark Law and Anti-Kickback Statute Regulations

McDermott Will & Emery on

The Department of Health & Human Services’ (HHS) proposed changes to the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law, released today as part of the Regulatory Sprint to Coordinated Care, would...more

Bricker Graydon LLP

CMS proposes changes to SNF/NF compliance program requirements

Bricker Graydon LLP on

On July 16, 2019, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule, entitled “Requirements for Long-Term Care Facilities: Regulatory Provisions To Promote Efficiency, and Transparency,” that, if...more

King & Spalding

CMS Releases FY 2020 Medicare IPPS and LTCH PPS Proposed Rule and Proposes Key Changes to Several Regulatory Requirements

King & Spalding on

On April 23, 2019, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System Proposed Rule for FY 2020 (the Proposed Rule), which will affect...more

Sheppard Mullin Richter & Hampton LLP

Overview of Proposed Rule from the Centers for Medicare & Medicaid Services Regarding Interoperability and Patient Access to Data

On March 4, 2019, the Centers for Medicare & Medicaid Services (“CMS”) published a wide-ranging proposed rule (“Proposed Rule”) with the intent to “move the health care ecosystem in the direction of interoperability” in...more

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