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Centers for Medicare & Medicaid Services (CMS)

Foley & Lardner LLP

The 340B Drug Pricing Program: Top Five Things to Know

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The 340B Drug Pricing Program continues to provide critical support for covered entities, although the program is subject to ongoing scrutiny and congressional, judicial, and industry pressures. Certain key guidance documents...more

Proskauer - Labor Relations Update

United States Government Accountability Office Finds Federal Contracting Rules do not Prohibit Labor Harmony Agreement...

In a decision issued on September 16, 2024, the United States Government Accountability Office (“GAO”) ruled that federal contracting rules do not prohibit government agencies from requiring contractors to enter into labor...more

Morgan Lewis

CMS Defers Low Wage Index Hospital Policy Changes in FY 2025 IPPS Final Rule Despite DC Circuit Holding

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The Centers for Medicare and Medicaid Services (CMS) has deferred taking immediate action on its low wage index hospital policy in light of the US Court of Appeals for the DC Circuit’s decision in Bridgeport Hospital v....more

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

McDermott+

McDermott+ Check-Up: September 13, 2024

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House Education & the Workforce Health, Employment, Labor, and Pensions Subcommittee Holds Hearing on ERISA’s 50th Anniversary. Members and witnesses assessed how the Employee Retirement Income Security Act of 1974 (ERISA)...more

Manatt, Phelps & Phillips, LLP

CMMI Transforming Maternal Health (TMaH) Model Applications Due Soon

On June 26, the Centers for Medicare & Medicaid Services (CMS) released the Notice of Funding Opportunity (NOFO) for the Transforming Maternal Health (TMaH) Model. TMaH is ten-year delivery and payment model designed to test...more

Robinson+Cole Data Privacy + Security Insider

CMS Notifies 946,801 Medicare Recipients of Data Breach

The Centers for Medicare & Medicaid Services (CMS) and the Wisconsin Physicians Insurance Corporation have announced that 946,801 current Medicare recipients are being notified that their personal information may have been...more

Holland & Knight LLP

Holland & Knight Health Dose: September 10, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Manatt, Phelps & Phillips, LLP

CMS Issues Guidance on Renewal Timeliness Post-Unwinding

On August 29, 2024, the Centers for Medicare & Medicaid Services (CMS) released a Center for Medicaid & Children’s Health Insurance Program (CHIP) Services (CMCS) Informational Bulletin (CIB) and an accompanying slide deck to...more

McDermott+

Biden Administration Issues Final Reg on Mental Health Parity Requirements

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Biden Administration Issues Final Reg on Mental Health Parity Requirements McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts....more

Health Care Compliance Association (HCCA)

The CMS Interoperability and Prior Authorization Rules

Healthcare lives on data. Getting it to the patient and providers is essential for delivering quality care, but that can be a challenge. As Eden Avraham-Katz, Vice President, Legal and Compliance at 1upHealth explains in...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - September 2024 #1

News Briefs - HHS Drops Appeal of Court's Ruling in Hospital Web Tracking Case - The Department of Health and Human Services is dropping its appeal of a June U.S. District Court ruling that vacated the government's...more

Goodwin

The Centers for Medicare & Medicaid Services Announces Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation

Goodwin on

As we have previously reported, the Inflation Reduction Act (IRA) changed the government’s treatment of certain prescription drugs under the Medicare program by directing the Secretary of Health and Human Services (HHS) to...more

Alston & Bird

Health Care Week in Review: CMS Releases Mandatory TEAM Hospital Participants and Issues RFI on Medicare Administrative Contractor...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Venable LLP

2025 Changes to Medicare Part D Will Impact Group Health Plans' Creditable Coverage Determination

Venable LLP on

The Inflation Reduction Act of 2022 made significant design changes to Medicare Part D effective January 1, 2025. The changes will cause an increase in the actuarial value of Medicare Part D coverage, which will impact...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

Sheppard Mullin Richter & Hampton LLP

Key Telehealth Updates in the CY 2025 Physician Fee Schedule Proposed Rule

On July 31, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued its proposed rule (“Proposed Rule”) for the 2025 Medicare Physician Fee Schedule, which includes implications for telehealth services reimbursable...more

Baker Donelson

Significant Changes Affecting Hospitals in CMS's FY 2025 IPPS Final Rule

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CMS published its FY 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule on August 1, 2024. Under this final rule, CMS is implementing several changes to its Hospital Inpatient Quality Reporting...more

McGuireWoods LLP

Ounce of Prevention: Are All Locations Where You Dispense DMEPOS Individually Enrolled in Medicare?

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Applicable Provider Types: Any individual or entity that receives Medicare reimbursement for selling or renting DMEPOS...more

Cooley LLP

US CMS Announces Initial Prices for Medicare Drug Price Negotiation Program

Cooley LLP on

On August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the first set of negotiated prices for the Medicare Drug Price Negotiation Program for 2026. Authorized under the Inflation Reduction Act of...more

McDermott+

No Surprises Act Implementation Bumpy Period Reaches One-Year Mark

McDermott+ on

We are now in September! And while many folks are thinking about how summer has come and gone so quickly, those following the No Surprises Act implementation process may also be wondering how a whole year has passed since the...more

McGuireWoods LLP

CMS 2025 Payment Proposals Could Impact Cardiology

McGuireWoods LLP on

The Centers for Medicare & Medicaid Services (CMS) recently published two proposed rules that could affect Medicare reimbursement for cardiology services. On July 22, 2024, CMS published the Calendar Year (CY) 2025 Hospital...more

King & Spalding

Transitional Coverage for Emerging Technologies: CMS’s Latest, But Not Necessarily Greatest, Coverage with Evidence Approach

King & Spalding on

On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2024 #4

News Briefs - Statistics Show Upward Trend in Healthcare Data Breaches - Healthcare data breach statistics clearly show there has been an upward trend in data breaches over the past 14 years, with 2021 seeing more data...more

Alston & Bird

Health Care Week in Review: Biden Administration Announces $100 Million for ACA Marketplace Navigators and $81.3 Million for...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

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