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Pharmaceutical Industry Centers for Medicare & Medicaid Services

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

The State AG Report Weekly Update

by Cozen O'Connor on

2018 AG Elections- Democrat Amy Padden Announces Bid for Colorado Attorney General- Democrat Amy Padden, former Executive Assistant U.S. Attorney and Law Enforcement Coordinator for the District of Colorado, announced...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

Manatt on Health: August 2017

Next Steps on Healthcare Reform - Though President Trump has continued to call for action on repeal and replace in the wake of the Senate’s failed vote at the end of July, congressional Republicans have been fairly muted...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 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

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

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republican leaders are expected to make a series of changes to the healthcare legislation released Thursday as they scramble to gain the support of at least 50 lawmakers in a showdown vote scheduled for later this...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

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

CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy

A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post...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

Ten Things Investors Need to Know About Value-Based Healthcare

by Ropes & Gray LLP on

This article highlights key business and legal issues related to value-based healthcare for investors considering opportunities in the healthcare industry. 1. Value-Based Arrangements Are Here to Stay Value-based...more

California Federal Court Allows Indirect Purchasers of Securities to Sue Issuers for Fraud Under California Statute

by Carlton Fields on

A federal magistrate judge in California has allowed a securities fraud suit against a late-stage private company to proceed despite the plaintiff investors holding a security interest only through intermediary,...more

New York Institutes New Medicaid Drug Price Control Measures

by King & Spalding on

State Budget Includes Medicaid Drug Expenditure Cap - On April 20, 2017, New York Governor Andrew Cuomo signed into law certain cost-control measures that attempt to cap the state’s Medicaid drug spending, making New York...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

Healthcare Law Update: March 2017

by Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals - On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...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

Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?

Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen. Although Mylan indicated...more

21st Century Cures Act Brings Medicare Reimbursement and Policy Changes in 2017

by Latham & Watkins LLP on

Changes include increased transparency, delayed DMEPOS payment reductions, changed reimbursement for infusion drugs, changed hospital policies and more. On December 13, 2016, President Obama signed into law the 21st...more

Healthcare Law Update: December 2016

by Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

The Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger

The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move...more

Medicare, Medicaid Payment Policies, Fraud Authorities Enacted as Part of 21st Century Cures Act

by Reed Smith on

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). While much of the focus has been on policies intended to accelerate drug and device development and approval, the Cures Act also...more

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