News & Analysis as of

Prescription Drugs Centers for Medicare & Medicaid Services

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

OIG Issues Top 25 Unimplemented Cost-Savings and Quality-Improvement Recommendations for HHS Programs

by Reed Smith on

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has released the 2017 edition of its Compendium of Unimplemented Recommendations (“Compendium”). In the Compendium, OIG identifies...more

Health Care Provider Insights - Introductory Edition

by Wilson Elser on

Welcome to the introductory edition of Health Care Provider Insights. We are practice management consultants, providing legal and business management advice and assistance to physicians and dentists (health care...more

"Double Dip" Effectively Approved by Center for Medicare and Medicaid Services

by Hogan Lovells on

Last week the Centers for Medicare and Medicaid Services (CMS) issued Release No. 104 to Manufacturers and Release No. 180, which invalidated earlier agency releases addressing the treatment under the Medicaid drug rebate...more

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

by Ruder Ware on

The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical...more

Seventh Circuit Grants Interlocutory Appeal in Rx Discount Program Qui Tam Suit to Answer Several Important Questions

by Ropes & Gray LLP on

In United States ex rel. Garbe v. Kmart Co., 824 F.3d 632 (7th Cir. 2016), the Seventh Circuit granted interlocutory appeal following numerous motions for partial summary judgment to consider four questions: (1) whether the...more

"Republicans Chart New Course for US Health Care System"

While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health care issues. More...more

Blog: Medicare Part B Demo Declared Dead

by Cooley LLP on

On Thursday, the Center for Medicare & Medicaid Services (CMS) announced that it would not move forward with its controversial Medicare Part B Payment Model (Part B Demo). The Part B Demo had come under heavy fire from...more

What a Trump Administration Could Mean for the 340B Drug Program

by K&L Gates LLP on

A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress...more

OIG Releases 2017 Work Plan

On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) is charged with ensuring the integrity of more than 100 programs administered by DHHS, including...more

CMS Releases the First Comprehensive Overhaul of Nursing Home Conditions of Participation in Over 25 Years

by Ruder Ware on

On October 4, 2016, the Center for Medicare and Medicaid Services (CMS) published a final rule to revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. CMS...more

Manatt on Health Reform: Weekly Highlights - October 2016 #2

Kentucky receives final approval from CMS to transition its Marketplace to the HealthCare.gov platform; Ohio puts a prescription drug price ceiling on its November 2017 ballot; and a new study links Medicaid expansion to...more

House Bill Would Block CMS Proposed New Payment Model for Part B Drugs

by King & Spalding on

The Congressional Budget Office (CBO) released a report on October 4, 2016, estimating that a bill in the U.S. House of Representatives to block the implementation of CMS’s proposed payment model for Part B drugs would cost...more

Manatt on Medicaid: Monthly Expansion Recap - September 2016

National News - Growth in Prescription Drug Spending Not Linked to Medicaid Expansion, Study Finds - Medicaid expansion was not likely a “major driving force” behind the record high drug spending growth in 2014,...more

211 Results
|
View per page
Page: of 9
Cybersecurity

"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:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.