Health Care

Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP).  Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to submit accurate ASP data to CMS.

On March 19th, Representative Michael C. Burgess, M.D. (R-TX) and Senate Finance Committee Chairman Orrin Hatch (R-UT) unveiled a bipartisan plan to repeal and replace the sustainable growth rate (SGR) physician payment system for physician reimbursement under Medicare.

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

Mintz’s Health Care Enforcement Defense Practice has published its most recent Qui Tam Update, highlighting two qui tam cases unsealed in November and December of 2014 and giving an overview of the other 17 cases unsealed during the same time period.

Last week, I had the honor of participating in a panel discussion about how health care entities deal with reported compliance concerns at the ABA’s 16th Annual Conference on Emerging Issues in Healthcare Law.

In a highly anticipated announcement on Tuesday, March 10, the Centers for Medicare and Medicaid Services (CMS) released details for a new Accountable Care Organization (ACO) program called the Next Generation ACO (NGACO). 

ML Strategies has posted its weekly Health Care Update. This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

Despite the efforts of the Department of Health and Human Services (HHS) to combat fraud and contain costs in federal healthcare programs, Medicare’s fee-for-service program (Parts A and B)  and Medicaid were two of the top three culprits for the billions reported to have been improperly paid by the federal government in fiscal year 2014.

As a final addition to our series on the 2016 Draft Call Letter, we highlight some of the MA contracting issues raised by the Centers for Medicaid and Medicare Services (“CMS”).

Mother Nature claimed another victim this week. The U.S. House of Representatives Energy and Commerce Subcommittee on Health was scheduled to hold a hearing on March 5, 2015 – Examining the 340B Drug Pricing Program.

For the last of our series on the 2016 Draft Call Letter, we focus on the provisions impacting plans serving Medicare-Medicaid, or dual eligible, enrollees. As we have previously posted, the Centers for Medicare & Medicaid Services (CMS) has struggled with how to provide high quality, seamless care to dual eligible individuals.

In past Call Letters, CMS has proposed and finalized significant changes to the Medicare Advantage risk adjustment system including, recalibrations, deletions and additions of diagnoses codes, and questioning of the value of in-house health risk assessments.

As part of our continuing series on CMS's 2016 Call Letter, we take a closer look at the provisions in the Call Letter affecting PBM and plan sponsor pharmacy networks.  In the Call Letter, CMS raises concerns about preferred pharmacy networks and maximum allowable cost (MAC) pricing, and also provides clarifying guidance on mail order pharmacy auto-ship policies.

Last week, the Federal Trade Commission and the Department of Justice co-hosted the second installment of their public workshop series, “Examining Health Care Competition.”

Earlier this month, Mintz Levin’s Hope Foster and Bridget Rohde hosted a webinar entitled “Health Care Enforcement in 2015: A Look Back on 2014 and Forecasting the Year Ahead.”

Last week, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) co-hosted the second installment of their public workshop series, “Examining Health Care Competition.”

In its February 20, 2015 Advance Notice of Methodological Changes for Calendar Year (CY) 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter, CMS addressed a variety of issues relating to its Star Ratings system.

The Federal Trade Commission (“FTC”) on Monday completed its review of Novartis AG’s (“Novartis”) proposed $16 billion acquisition of GlaxoSmithKline’s (“GSK”) oncology drug portfolio with an announced consent decree that requires limited divestitures of BRAF- and MEK-inhibitor drugs used to treat melanoma, ovarian, colorectal, non-small cell lung, and other cancers.

On February 25, 2015, in a 6-3 decision authored by Justice Kennedy, the Supreme Court upheld the Federal Trade Commission’s decision finding that the North Carolina Board of Dental Examiners, although a state agency, was not exempt from federal antitrust laws when it sent 47 official cease-and-desist letters to non-dentist teeth whitening service providers.

On February 25, 2015, in a 6-3 decision authored by Justice Kennedy, the Supreme Court upheld the Federal Trade Commission’s (FTC) decision finding that the North Carolina Board of Dental Examiners (Board), although a state agency, was not exempt from federal antitrust laws when it sent 47 official cease-and-desist letters to non-dentist teeth whitening service providers.