News & Analysis as of

Healthcare Medicare Part B Prescription Drugs

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

ArentFox Schiff

Health Care Providers Navigate Fallout of Major Cyberattack on Change Healthcare

ArentFox Schiff on

Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records. On February 21, Change disconnected its...more

McDermott Will & Schulte

This Week in 340B: September 2023 #4

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Bass, Berry & Sims PLC

CMS Proposes $9 Billion Refund to 340B Hospitals and Reductions in Future Payments to All Hospitals for Non-Drug Services

Bass, Berry & Sims PLC on

On July 7, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to implement a remedy in response to last year’s Supreme Court decision finding the Medicare Part B payment policy for hospitals in the 340B...more

Quarles & Brady LLP

The Current State of 340B and What to Expect in 2023

Quarles & Brady LLP on

2022 was an eventful year on the 340B front, packed with updates to consequential litigation, proposed new rules, ongoing uncertainty into the Health Resources and Services Administration's (HRSA) underlying enforcement...more

McDermott Will & Schulte

The Inflation Reduction Act of 2022: Healthcare Provisions

After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...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

Quarles & Brady LLP

U.S. Supreme Court Sides with 340B Hospitals in Significant $1.6 Billion Part B Drug Payment Ruling

Quarles & Brady LLP on

On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more

King & Spalding

CMS Issues Final Rule Implementing Changes to Medicare Appeals Procedures

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On May 3, 2019, CMS issued its final rule implementing changes to the appeal procedures for Medicare claims and Medicare prescription drug coverage determinations (the Final Rule). The Final Rule will be published in the...more

Mintz - ML Strategies

Health Care Update - November 2015

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Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

McDermott Will & Emery

Congress Take Step Toward Site-Neutral Medicare Payments in Bipartisan Budget Act of 2015

McDermott Will & Emery on

On October 28, 2015, the U.S. House of Representatives approved legislation that, if enacted, would, among other things, substantially alter how and how much Medicare pays for outpatient services furnished by hospitals. The...more

Mintz - ML Strategies

Health Care Update - October 2015

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Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

King & Spalding

OIG Reports Medicare Part B Overpaid $35.8 Million for Outpatient Drugs

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According to a recent report by the HHS Office of Inspector General (OIG), Medicare contractors in 13 jurisdictions overpaid providers by $35.8 million for select outpatient drugs, including injectable drugs used for cancer...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... Healthcare.gov CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more

King & Spalding

GAO Report Concludes Prescribing Incentives Exist at 340B Hospitals

King & Spalding on

According to a report released July 6, 2015 by the Government Accountability Office (GAO), hospitals that qualify to participate in the 340B Drug Pricing Program by virtue of their serving a disproportionate share of...more

Arnall Golden Gregory LLP

GAO Recommends Congress Reduce Incentives for Prescribing 340B Drugs

The United States Government Accountability Office (GAO) recently released a report entitled “Medicare Part B Drugs: Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals” (“the...more

Patterson Belknap Webb & Tyler LLP

The Soon-to-be Reality of Medicare Part B Reimbursements for Biosimilars

As the country’s largest health insurer, Medicare has immense influence on the health care market. In the wake of the recent approval of Sandoz’s Zarxio (filgrastim-sndz), the first FDA-approved biosimilar, last month the...more

BakerHostetler

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

BakerHostetler on

On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the...more

King & Spalding

CMS to Congress: Sequestration of Cancer Drug Reimbursement to Continue

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A June 3, 2013 letter from CMS Administrator Marilyn Tavenner to Rep. Pete Sessions (R-Tex.) states that the agency does not believe it has any discretion under the Budget Control Act of 2011 to exempt Part B cancer drug...more

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