News & Analysis as of

Medicare New Guidance Pharmaceutical Industry

Manatt, Phelps & Phillips, LLP

CMS Announces Part D Premium Parameters, New Policy to Stabilize Standalone Part D Premiums

The Centers for Medicare & Medicaid Services (CMS) released the Part D national average bid amount and Part D base beneficiary premiums for 2025. These figures set the premium costs and government subsidies for Medicare...more

Cornerstone Research

Potential Unintended Economic Impacts of the Inflation Reduction Act on the Pharmaceutical Industry

Cornerstone Research on

The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more

Sheppard Mullin Richter & Hampton LLP

CMS Releases Guidance on Implementation of Rebate Programs for Certain Medicare Part B and Part D Drugs

On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released two highly-anticipated guidance documents (the “Guidance”) detailing the agency’s proposed implementation of the Medicare Part B (“Part B”)...more

McDermott Will & Emery

[Webinar] 2019 Q4 Healthcare Enforcement Roundup - February 5th, 2:30 pm ET

McDermott Will & Emery on

The final quarter of 2019 brought forward new guidance and proposed rules with major implications for healthcare companies, enforcement developments in healthcare private equity investing and opioid litigation matters, among...more

Mintz - Health Care Viewpoints

CMS’s Advance Notice and Call Letter: How Medicare Plans Can Report, Identify, and Address the Opioid Epidemic

CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their...more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

On November 15, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017. The Biosimilar User Fee Amendments of 2017 (BsUFA II)...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

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

Cooley LLP

Blog: CMS Announces Updated Guidance Related to CME Reporting and Issues New Sunshine FAQs

Cooley LLP on

Last week, the Centers for Medicare & Medicaid Services (CMS) announced that it updated its Open Payments Law and Policy webpage and issued 3 frequently asked questions (FAQs) related to the reporting of payments and...more

King & Spalding

Also In The News - Health Headlines - April 2015

King & Spalding on

Guidance Issued on Payment for Biosimilars – On March 30, 2015, CMS released three guidance documents detailing the policies that will govern FDA-approved biosimilars under the Medicare Part B and Part D benefits, and how...more

Mintz - Health Care Viewpoints

CMS Takes Initial Steps to Address Medicare & Medicaid Coverage for Biosimilars

On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more

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