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Proposed Rules Healthcare Comment Period

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

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

Troutman Pepper 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 & Emery

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

McDermott Will & Emery on

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

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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

Manatt, Phelps & Phillips, LLP

FTC Proposal Restricts Health Tech and Digital Health Companies’ Use of Auto-Renewal Provisions

Many health tech and digital health companies offer subscription or membership services to clients and patients on an auto-renewal basis. Under this model, a subscriber’s credit card is automatically charged on a monthly,...more

Stevens & Lee

FTC Proposes Banning and Rescinding Worker Non-Competes

Stevens & Lee on

On January 5, 2023, the U.S. Federal Trade Commission (FTC) issued a proposed rule that would prohibit nearly all non-compete clauses between employers and workers going forward and would also require employers to promptly...more

Robinson+Cole Health Law Diagnosis

No More Reasonable Diligence? CMS Proposes to Change Standard for Identifying Medicare Overpayments to Align with False Claims Act

On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule (Proposed Rule) which proposes certain policy and technical changes to Medicare regulations, including a notable change to the...more

Groom Law Group, Chartered

CMS Proposed Rule Would Leverage Technology and Interoperability to Improve Prior Authorization

On Tuesday, December 13, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule (“New Proposed Rule”) to improve the prior authorization process and advance interoperability for Medicare Advantage...more

Robinson+Cole Health Law Diagnosis

HHS Proposes Rule to Align Part 2 Records and HIPAA

On November 28, 2022, the Department of Health and Human Services (HHS) issued a proposed rule to modify the confidentiality protections of Substance Use Disorder (SUD) patient treatment records under 42 CFR Part 2 (Part 2)...more

Burr & Forman

Proposed Rules Could Impact How Health Care Providers Handle Medical Waste

Burr & Forman on

In August 2022, the Alabama Department of Environmental Management (“ADEM”) published proposed changes to its rules for public comment. Specifically, the rules affect how a healthcare provider stores medical waste. If the...more

Polsinelli

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

Polsinelli on

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

Quarles & Brady LLP on

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

Arnall Golden Gregory LLP

Roll With the Changes: FDA’s Proposed Amendments to Converge its Quality Management System Requirements With ISO Requirements

In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more

Bass, Berry & Sims PLC

HSDA Issues Draft Rules to Accompany Public Chapter 557

On June 30, in response to Public Chapter No. 557 (new law), which makes significant changes to Tennessee’s certificate of need (CON) program, the Health Services and Development Agency (HSDA) issued draft emergency rules and...more

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