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McDermott+

Responses to the PFS Proposed Reg Are In: 10 Major Comments

McDermott+ on

McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. September 19, 2024 – Comments on the calendar year (CY) 2025 physician fee...more

Bass, Berry & Sims PLC

CMS Solicits Comments to Clarify Parameters on MAC Downcoding of Complex Drug Administration Infusion Services

In the proposed CY 2025 Physician Fee Schedule (PFS) published in the Federal Register on July 31, the Centers for Medicare & Medicaid Services (CMS) is soliciting comments on a proposal to revise the Medicare Claims...more

Pullman & Comley - Connecticut Health Law

OHS Issues 2024 Statewide Health Care Facilities and Services Plan

The Connecticut Office of Health Strategy (OHS) has released the 2024 Statewide Health Care Facilities and Services Plan, along with a biennial inventory of all Connecticut health care facilities and services (the Plan)....more

Burr & Forman

Proposed Revisions to Title II of the ADA Impacting Healthcare Facilities

Burr & Forman on

The Department of Justice recently published a notice of proposed rulemaking applicable to healthcare entities covered under Title II of the Americans with Disabilities Act that relates to accessibility to medical diagnostic...more

McDermott+

CMMI Proposes New Mandatory Episode-Based Payment Model

McDermott+ on

Last week, the Centers for Medicare & Medicaid Services (CMS) released the Fiscal Year 2025 Inpatient Prospective Payment System (IPPS) proposed regulation. This 1,900+ page annual reg updates Medicare payments and policies...more

Mayer Brown

Private Equity in Healthcare: Increased Scrutiny from FTC, DOJ, and HHS

Mayer Brown on

Private equity acquisitions in healthcare will likely face increased scrutiny from multiple federal departments, as well as from state antitrust enforcement officials....more

Jones Day

FDA Issues Revised Off-Label Communications Guidance

Jones Day on

The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more

Sheppard Mullin Richter & Hampton LLP

From Good Reprint Practices to SIUU Communications: What Firms Need to Know

On October 23, 2023, the Food and Drug Administration (“FDA”) published a new draft guidance, titled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

Bass, Berry & Sims PLC

Court Guts 340B Program “Patient” Definition, Opening Door to More 340B Use

Bass, Berry & Sims PLC on

On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

Husch Blackwell LLP

Revised California Regulations for Reporting Health Care Transactions

Husch Blackwell LLP on

In July of this year, the California Office of Health Care Affordability (“OHCA”) released draft regulations requiring the advance reporting of certain healthcare transactions that could affect the cost of healthcare or...more

Nelson Mullins Riley & Scarborough LLP

The Drive for Equitable Healthcare Access: Departments Seek Public Input on Over-the-Counter Preventive Services

On September 29, the Centers for Medicare & Medicaid Services (CMS) reported that the federal Departments of Health and Human Services, Labor, and the Treasury departments are seeking public input on the possibility of...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

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

Sheppard Mullin Richter & Hampton LLP

CFPB, other Federal Agencies Seek Public Comment about Medical Debt

On July 7, the CFPB, HHS, and Treasury announced a joint inquiry into high-cost specialty financial products which are being offered to patients as alternate forms of payment for routine medical care. Traditionally, these...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

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

Bass, Berry & Sims PLC

Top 10 Physician Practice Management Transactional Structure and Operational Challenges

Bass, Berry & Sims PLC on

Physician practice management (PPM) platforms have been a staple for over a decade in their current form and are considered a mainstay of private equity’s investment in healthcare. PPMs have a number of unique transaction...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

Nelson Mullins Riley & Scarborough LLP

Proposed Changes to Confidentiality of Substance Use Disorder Patient Records Rules Would Support Better Care, Decrease Stigma,...

Amid the ongoing proliferation of headlines about the mental health crisis in the United States, of which substance use disorder is a large part, the recent issuance by the U.S. Department of Health and Human Services (HHS)...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

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

Polsinelli

SCOTUS 340B Decision Drives CMS to Restore Part B 340B Payments and Seek Comments on Remedies in the CY 2023 OPPS Proposed Rule

Polsinelli on

On Friday, July 15th, CMS published its CY 2023 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule) and gave 340B covered entities a glimpse into how the agency intends to react to...more

Manatt, Phelps & Phillips, LLP

OMIG Proposes Omnibus Regulations Impacting Medicaid Providers’ and Plans’ Compliance Obligations

On July 13, 2022, the New York State Office of Medicaid Inspector General (OMIG) published proposed rules in the New York State Register to implement provisions of the State Fiscal Year 2020-2021 Enacted Budget and the...more

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