News & Analysis as of

Medicare New Guidance Prescription Drugs

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

Holland & Knight LLP

Holland & Knight Health Dose: March 21, 2023

Holland & Knight LLP on

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. This week's topics include ... ...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

Bass, Berry & Sims PLC

Specialty Pharmacy Compliance During COVID-19 Pandemic

Bass, Berry & Sims PLC on

The recent Centers for Medicare & Medicaid Services (CMS) memorandum to all Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans (CMS Memo) does not provide any express relief for specialty...more

Holland & Knight LLP

CMS Offers Additional COVID-19 Guidance for Medicare Advantage and Part D Plans

Holland & Knight LLP on

The Centers for Medicare and Medicaid Services (CMS) continues to offer guidance related to the coronavirus (COVID-19) outbreak. On March 10, CMS issued a memo to all Medicare Advantage (MA) organizations and Part D sponsors...more

Baker Donelson

A Flurry of Recent Activity Highlights Continued Interest in 340B Program Oversight

Baker Donelson on

Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more

ArentFox Schiff

Investigations Newsletter: DOJ Issues Guidance on Ability-to-Pay in False Claims Act Cases

ArentFox Schiff on

DOJ Issues Guidance on Ability-to-Pay in False Claims Act Cases - On October 8, 2019, Assistant Attorney General Brian Benczkowski announced new guidance for federal prosecutors evaluating whether a corporation is unable...more

Baker Donelson

CMS Issues Updated Medicare Payment and Billing Policies for 340B Hospitals

Baker Donelson on

On April 2, 2018, CMS issued updated guidance related to the dramatic Medicare payment reductions that went into effect this year for certain 340B hospitals. The guidance explains the planned application of the payment cuts...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

Buchalter

OIG Finalizes New and Expanded Anti-Kickback Safe Harbors, Issues Guidance Regarding Nominal Gifts

Buchalter on

In an uncertain health care environment following the presidential election, the Department of Health & Human Services Office of Inspector General (“OIG”) finalized a new rule expanding existing safe harbors to the federal...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

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