News & Analysis as of

Medicare Draft Guidance

Manatt, Phelps & Phillips, LLP

Maryland PDAB Releases Draft Upper Payment Limit Action Plan

On August 9, Maryland’s Prescription Drug Affordability Board (PDAB) released its draft action plan for establishing upper payment limits (UPLs) for drugs identified as causing or likely to cause affordability challenges. The...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Learning From Experience: Medicare Drug Price Negotiation Program Updates

Since our last edition of the Mintz IRA Update, the Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”) and related maximum fair price (MFP) negotiation process for each of the 10 high-expenditure...more

Goodwin

IRA Litigation Updates: D.N.J. Rejects Challenges from BMS and Janssen; Four Cases Now on Appeal

Goodwin on

On April 29th, the district court for the district of New Jersey (J. Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program....more

Hogan Lovells

CMS Issues Draft Guidance on Inflation Reduction Act (IRA) Drug Price Negotiation Program for 2027

Hogan Lovells on

On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the...more

Mintz

Mintz IRA Update — Biden Administration Proposes Allowing Agencies to 'March-In' to Control Rising Drug Prices

Mintz on

The Biden administration appears steadfast in its efforts to lower prescription drug costs and continues to explore multiple avenues — even as the Medicare Drug Price Negotiation Program continues to move forward — to tackle...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

King & Spalding

CMS Issues Draft Guidance for Implementing Medicare Prescription Payment Plan for 2025

King & Spalding on

On August 21, 2023, CMS issued the first of two draft guidance documents for implementing the Medicare Prescription Payment Plan that was established by section 11202 of the Inflation Reduction Act (IRA) and signed into law...more

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 11

McGuireWoods LLP on

A former DePuy Synthes sales representative is arrested for allegedly defrauding a hospital into submitting claims for products not actually used in surgery; A number of additional clinics enter into settlements to resolve...more

Holland & Knight LLP

Healthcare Law Update: October 2021

Holland & Knight LLP on

Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Holland & Knight LLP

Healthcare Law Update: October 2019

Holland & Knight LLP on

In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

Epstein Becker & Green

CMS Releases Draft Guidance on Shared Space Arrangements

Epstein Becker & Green on

The Centers for Medicare & Medicaid Services (“CMS”) recently released draft guidance for state survey agencies regarding shared space and co-location arrangements between hospitals and other hospitals or health care...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues Long-Awaited Draft Guidance for Hospital Co-Location with Other Hospitals or Healthcare Facilities

On May 3, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released long-awaited draft guidance (the “Guidance”), proposing to allow hospitals to co-locate with other hospitals or healthcare facilities in certain...more

Dorsey & Whitney LLP

At Long Last, CMS Issues Proposed Guidance on Hospital Co-Locations

Dorsey & Whitney LLP on

For years, CMS has informally applied restrictions for hospitals which share space, equipment, staff or services in the same physical location (i.e., “co-locate”) with other hospitals or health care entities. Although these...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

King & Spalding on

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

McDermott Will & Emery

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

Foley & Lardner LLP on

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...more

18 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide