Affordable Care Act, Proposed Rules

Affordable Care Act Overpayments in the CY 2025 Medicare Physician Fee Schedule Proposed Rule: Implications for False Claims

Epstein Becker & Green on 8/13/2024

Stakeholders are continuing to analyze the implications of the mammoth proposed rule on “Medicare and Medicaid Programs: [Calendar Year (CY)] 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B...more

Final Section 1557 Rules: Highlights for Health Plan Sponsors

Ballard Spahr LLP on 6/19/2024

The U.S. Department of Health and Human Services (HHS) has issued final regulations on the nondiscrimination rules set forth in Section 1557 of the Affordable Care Act. The new rules apply to certain group health plans, as...more

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

McDermott+ on 5/9/2024

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

OCR, CMS Issue New ACA Section 1557 Final Rule Prohibiting Discrimination Related to Use of Artificial Intelligence in Health Care

Mintz - Health Care Viewpoints on 4/30/2024

Preventing discrimination and bias in connection with the use of artificial intelligence (AI) in health care are among the principal current focuses of U.S. Department of Health and Human Services (HHS) and were included in...more

HHS Issues 340B Administrative Dispute Resolution Final Rule

McDermott Will & Emery on 4/24/2024

On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more

CMS Promotes Health Equity through Marketplace Standards and More in New Proposed Rule

Sheppard Mullin Richter & Hampton LLP on 12/11/2023

On November 24, 2023, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (“CMS”) published a proposed rule to modify certain Patient Protection and Affordable Care Act (“ACA”)...more

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

ArentFox Schiff on 10/25/2023

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more

Comprehending the Non-Comprehensive: Proposed Rules Tackle Non-Traditional Coverage

Ballard Spahr LLP on 7/21/2023

The Departments of Labor, Health and Human Services, and the Treasury have published a set of proposed rules that impose new limits on two types of benefits: short-term limited-duration insurance (STLDI) and fixed indemnity...more

Joint Proposed Rule Aims to Increase Consumer Protections Under the Affordable Care Act

King & Spalding on 7/18/2023

HHS, the Department of Labor’s Employee Benefits Security Administration, and the Internal Revenue Service (IRS) (collectively, the Departments) issued a proposed rule on July 7, 2023, aimed at shoring up consumer protections...more

Drastic Scheduled Cuts to Disproportionate Share Hospital Funding Would Increase Financial Distress for Safety Net Hospitals

ArentFox Schiff on 3/31/2023

Over 2500 hospitals across the country historically have relied upon Disproportionate Share Hospital (DSH) Medicaid payments for financial stability. These DSH payments, made in large measure to hospitals with high Medicaid...more

CMS Proposes Changes to Medicaid DSH Third-Party Payer Rule

King & Spalding on 3/2/2023

On February 24, 2023, CMS issued a proposed rule updating its Medicaid Disproportionate Share Hospital (DSH) program regulations as a result of legislative changes made by the Consolidated Appropriations Act (CAA) of 2021....more

Proposed Rules Expand Access to Contraceptive Care as a Preventive Service

Snell & Wilmer on 2/23/2023

On January 30, 2023, the Departments of Health and Human Services, Treasury, and Labor (collectively “the Departments”) issued proposed rules entitled “Coverage of Certain Preventive Services under the Affordable Care Act”...more

Proposed Universal Contraceptive Coverage in Response to Roe Reversal

McDermott Will & Emery on 2/9/2023

The US Departments of Health and Human Services, Labor and Treasury (the Departments) recently issued a proposed rule (the proposed rule) to eliminate a moral exemption to the Affordable Care Act (ACA) contraceptive mandate...more

Health Equity Elevated to a Joint Commission National Patient Safety Goal

McDermott Will & Emery on 2/1/2023

Starting July 1, 2023, The Joint Commission (TJC) will set health equity as a National Patient Safety Goal for certain TJC-accredited organizations and roll out a new Health Care Equity certification program to recognize and...more

CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard

Mintz - Health Care Viewpoints on 1/18/2023

The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more

HHS Proposes Health Insurance Market Reforms for 2024

Sheppard Mullin Richter & Hampton LLP on 1/4/2023

On December 21, 2022, the Department of Health and Human Services (“HHS”) issued a proposed rule aimed at advancing health equity and mitigating health disparities while minimizing administrative burden...more

Will CMS’s Proposed Rule on “Identified Overpayments” Increase Reverse FCA Cases?

Foley & Lardner LLP on 1/3/2023

On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more

CMS Proposes Standardizing Electronic Health Care Attachments Transactions

King & Spalding on 12/29/2022

On December 21, 2022, HHS issued a new proposed rule to implement the requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Patient...more

CMS Includes MAOs in Data Exchange and Prior Authorization Requirements

Sheppard Mullin Richter & Hampton LLP on 12/16/2022

The Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule, “Advancing Interoperability and Improving Prior Authorization Processes” (the “Proposed Rule”), that is intended to improve patient and provider...more

Several New Group Health Plan Reporting Deadlines Are Approaching – Check Out Our CAA/Price Transparency Checklist

Foley & Lardner LLP on 12/16/2022

This year, Foley’s Health Benefits Practice has released multiple alerts on several of the new group health plan requirements set forth by the Consolidated Appropriations Act of 2021 (CAA) and the Transparency in Coverage...more

HRSA Proposes Changes to ADR Procedures for 340B Disputes

King & Spalding on 12/9/2022

On November 29, 2022, the Health Resources and Services Administration (HRSA) issued a proposed rule (Proposed Rule) to revise the alternative dispute resolution (ADR) procedures for disputes arising under the 340B drug...more

Twenty-One State Attorneys General and the District of Columbia Back HHS’s Plan to Hold Hospitals and Other Providers Liable for...

King & Spalding on 10/14/2022

On October 3, 2022, the Attorneys General for California, New York, and Massachusetts, in collaboration with Attorneys General from 18 other states and the District of Columbia (State Attorneys General) submitted a comment...more

Biden Administration Proposal Restores, Updates Obama-Era Affordable Care Act Section 1557 Rules

Groom Law Group, Chartered on 10/10/2022

On August 4, 2022, the Biden Administration published its long-anticipated proposed rulemaking on Affordable Care Act (“ACA”) Section 1557’s nondiscrimination in health programs and activities requirements (“Proposed Rule”)....more

HHS highlights significance of new healthcare technologies in series of regulatory actions

Hogan Lovells on 9/16/2022

Recent U.S. Department of Health Human Services (HHS) regulatory actions emphasize the role emerging technologies play in the provision of healthcare, particularly as clinical innovations proliferate in response to the...more

It’s Time To Review Your Online Patient-User Interface: DOJ Issues New Federal Guidance on Telemedicine and Civil Rights...

Foley & Lardner LLP on 9/13/2022

As online digital health services continue to enjoy broader use and appeal, federal regulators are concerned some telemedicine online patient-user interfaces fail to accommodate persons with disabilities and limited English...more

Patient Protection and Affordable Care Act (PPACA) › Proposed Rules

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