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Prescription Drugs Centers for Medicare & Medicaid Services

K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs

by K&L Gates LLP on

In this episode, Richard Church and Ryan Severson discuss the recent decision by the Centers for Medicare and Medicaid Services (CMS) to substantially decrease reimbursement under the Outpatient Prospective Payment System...more

Top Takeaways for Medicare Physician and Hospital Payments in 2018

by Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2017, released the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) Payment System Final Rule for...more

CMS Finalizes Reimbursement Cuts for 340B Hospitals

by Foley & Lardner LLP on

In a striking blow to 340B hospitals, the Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) released a final Medicare Outpatient Prospective Payment System (OPPS) rule adopting its...more

CMS Announces New Policy for Biosimilars Payments Under Part B

by Goodwin on

As we previously reported, the Centers for Medicare and Medicaid Services (“CMS”) has been considering comments on a proposed rule regarding biosimilar payment policies. On Thursday, CMS issued a final rule for the 2018...more

340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs

by K&L Gates LLP on

On November 1, 2017, the Centers for Medicare and Medicaid Services (“CMS”) issued a final rule updating the Medicare hospital Outpatient Prospective Payment System (“OPPS”) for the calendar year 2018. As part of this update,...more

Newly-Announced 340B Payment Rule Presents Financial & Operational Challenges to All Covered Entities

by Polsinelli on

In its 2018 Outpatient Prospective Payment System final rule (Final Rule) issued Nov. 1, Centers for Medicare and Medicaid Services (CMS) implemented a significant Medicare Part B payment reduction for separately payable,...more

CMS Finalizes Medicare Part B Reimbursement Cut for 340B – What Does it Mean?

On November 1, 2017, CMS announced that it is in fact cutting Medicare Part B reimbursement for 340B drugs to the tune of $1.6 billion. To be accurate, what CMS announced is its intent to finalize proposed rule changes to the...more

Health Care E-Note - October 2017

by Burr & Forman on

Health care providers are constantly receiving requests for copies of patient medical records. Some requests come by way of the patient exercising his/her right to access his/her medical records, some come by way of patient...more

CMS Completes Final Medicare Part D Reconciliation for 2016

CMS has completed the 2016 Final Part D Payment Reconciliation. Each Medicare Part D plan sponsor’s reconciliation reports will be available on October 12, 2017....more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

October 15th Deadline: Medicare Part D Notice Of Creditable (Or Non-Creditable) Coverage

by Fraser Trebilcock on

UPDATED: September 19, 2017 – Employers who offer prescription coverage to any Medicare Part D eligible employees (whether or not retired), or Medicare Part D Medicare-eligible spouses or dependents, you must provide those...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program

by K&L Gates LLP on

cmsThis episode outlines the basics of the 340B Drug Pricing Program and discusses potential changes affecting the program, including CMS’s recent proposal to cut reimbursement for Part B drugs purchased under the 340B...more

340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts

by Polsinelli on

In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more

Witnesses at Congressional Hearing on 340B Urge Congress To Give HRSA Broader Regulatory Authority

On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015. A...more

CMS Proposes Reimbursement Reduction for 340B Drugs

by Baker Ober Health Law on

When CMS issued its proposed rule for OPPS and ASC Payment System on July 13, the agency included a proposal to substantially scale back reimbursement for Part B drugs to hospitals participating in the federal 340B Drug...more

CMS Considers New Billing Code Policy for Biosimilars

by Goodwin on

Last week, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule regarding payment policies. Among other things, the proposed rule included a request for comment on the policy for biosimilar...more

New Medicare Proposals that Reduce Payment to Hospitals for 340B Drugs in 2018

by Dorsey & Whitney LLP on

On July 13, 2017, CMS released several proposed rules impacting health care, including the 2018 Outpatient Prospective Payment System (OPPS) proposed rule which, among other proposals, could have a significant impact on 340B...more

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more

340B Update: CMS Proposes to Reduce 340B Drug Reimbursement; Draft Executive Order Could Mean Further Changes to the 340B Program

by K&L Gates LLP on

The Trump administration is considering significant changes relating to the 340B Drug Pricing Program (“340B Program”), which allows certain categories of safety net providers to access discounted pricing on covered...more

Expected Executive Order to take on High Drug Prices; Senate Committee Hears Recommendations on Drug Supply Chain from Experts

by Dorsey & Whitney LLP on

According to an article posted today on the BioCentury website, the Trump administration is drafting an executive order that will take on the high costs of pharmaceuticals by instructing “executive agencies to use value-based...more

SEC and U.S. Attorney’s Office Continue Their Pursuit of Criminal Actions Against Purveyors of “Political Intelligence”

by Foley & Lardner LLP on

On May 24, 2017, the United States Attorney’s Office for the Southern District of New York and the Securities and Exchange Commission (SEC) launched their latest criminal and civil salvos against prohibited insider trading by...more

Manatt on Health Reform: Weekly Highlights - June 2017

House Ways and Means Committee advances three discrete healthcare bills as part of the broader repeal and replace effort; Nevada sends Medicaid-for-all legislation to the Governor; and New York requires insurers to remain in...more

Measures of success: How value-based pricing may change the pharmaceutical industry

by Hogan Lovells on

Adoption of value-based pricing, where drug prices are linked to real-world outcomes rather than on a per-pill or per-treatment basis, will have a profound impact on the pharmaceutical industry. And with the Centers for...more

Measures of success: How value-based pricing may change the pharmaceutical industry

by Hogan Lovells on

Hogan Lovells partner Alice Valder Curran teams up with Robert Spurr of Novartis to outline the challenges and share potential solutions to consider when entering into value-based pricing arrangements. Adoption of...more

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