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Healthcare Reform › Regulatory Requirements › Comment Period

Sheppard Mullin Richter & Hampton LLP

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

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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

Foley Hoag LLP

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

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After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

Proskauer - Health Care Law Brief

Proposal to Increase Penalties for a Hospital’s Failure to Comply with Price Transparency Rule

Proskauer - Health Care Law Brief on

As discussed in a prior post, the Hospital Price Transparency Rule at 45 C.F.R. § 180.10 et. seq. (the “Rule”), requires all hospitals to provide clear, accessible pricing information about the items and services they provide...more

Hogan Lovells

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

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The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...more

Polsinelli

HHS Extends 21st Century Cures Act Final Rule Compliance Dates for Information Blocking and Health IT Certification Requirements

Polsinelli on

On October 29, 2020, the Office of the National Coordinator for Health Information Technology (ONC) announced it was delaying the compliance deadlines for information blocking and other health IT provisions initially...more

Stinson LLP

FDA Proposes (Again) to Amend the "Intended Use" Regulation

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This week, FDA published a proposed rule that would amend its medical product "intended use" regulations, 21 CFR §§ 201.128 and 801.4 and replace the 2017 Final Rule about the same issue that never became effective....more

Burr & Forman

Proposed Stark Law Changes May Impact Physician Compensation Models

Burr & Forman on

On October 9, 2019, the Centers for Medicare and Medicaid Services (“CMS”) proposed sweeping changes to the federal Physician Self-Referral Law, commonly referred to as the Stark Law. While many of the changes reflect CMS’...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

Hogan Lovells

CMS Innovation Center seeks input on Oncology Care Model sequel

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In a late-night announcement on Friday, 1 November, the Center for Medicare and Medicaid Innovation (CMMI) gave cancer providers the first look at a possible sequel to the Oncology Care Model (OCM). ...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

Robinson+Cole Health Law Diagnosis on

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

Womble Bond Dickinson

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

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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

Faegre Drinker Biddle & Reath LLP

New Stark Law Exceptions for Value-Based Care

Faegre Drinker Biddle & Reath LLP on

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

Mintz - Health Care Viewpoints

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

Mintz - Health Care Viewpoints on

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 & Schulte

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

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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

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