Author: Nicole Burgmeier

Nicole practices in the area of health law advising pharmacies, hospitals, long-term care providers, and medical practices on a variety of regulatory, compliance, and corporate transactional matters. She regularly advises on issues related to Medicare and Medicaid, state and federal privacy laws, state pharmacy laws, medical staff bylaws, tax-exempt status, certificate of need appeals, corporate structures and formation, and state and federal licensure.

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Uncategorized

July 18, 2017

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

On July 13, 2017, CMS released several proposed rules impacting health care, including the 2018 Outpatient Prospective Payment System (OPPS) proposed rule [available here https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-14883.pdf] which, among other proposals, could have a significant impact on 340B covered entities. The proposed rule states that CMS will change how Medicare pays hospitals that participate in the 340B...

Executive Orders

June 21, 2017

New York Times Obtains Copy of Draft Executive Order on Drug Prices; FDA Blogs that it is Working to Lift Barriers to Generic Drug Competition

New York Times Obtains Copy of Draft Executive Order on Drug Prices; FDA Blogs that it is Working to Lift Barriers to Generic Drug Competition On June 20, 2017, the New York Times reported that it had obtained a draft proposal of President Trump’s Executive Order on drug prices.[1] The draft Executive Order, which has...

Executive Orders / Healthcare Payment and Reimbursement

June 15, 2017

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

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 contracts for drug purchases, and to pursue trade policies that enhance the intellectual property rights of American pharmaceutical companies.” This is...

Healthcare Payment and Reimbursement / OIG Guidance

February 23, 2017

OIG Announces Drug Pricing and Reimbursement Web Portfolio

On February 17, 2017 the Office of the Inspector General (OIG) posted a Drug Pricing and Reimbursement Web portfolio on its website that, according to the OIG announcement, “pulls together the HHS OIG’s body of work since 2010 as well as other relevant items that relate to drug pricing and reimbursement in HHS programs.” The...

OIG Guidance

November 14, 2016

OIG Releases 2017 Work Plan

Executive Summary The United States Department of Health and Human Services Office of the Inspector General (“OIG”) published its Fiscal Year 2017 Work Plan (“2017 Plan”) on November 10, 2016. The work plan is published annually by the OIG and identifies new and ongoing investigative, enforcement and compliance priorities for the OIG in the upcoming...

Uncategorized

October 19, 2016

Omnicare Inc. Settles Kickback Allegations for $28 Million

Shared post from the Dorsey FCA NOW blog, October 19, 2016.

Opioids / Pharmacy

October 17, 2016

The Changing Landscape of the Fight Against Opioid and Heroin Addiction and the Availability of Naloxone

In recent months, the Obama administration and many health and pharmaceutical players at the state and local levels have focused their attention on the national opioid epidemic. Based on recent findings from the National Center for Injury Prevention and Control, approximately 40 Americans die each day from overdoses involving prescription opioids. Additionally, according to the...

Healthcare Payment and Reimbursement

July 14, 2016

CMS Issues Proposed Rule Addressing Off-Campus Outpatient Departments

July 14, 2016 The Centers for Medicare and Medicaid Services (CMS) published its 2017 Medicare Outpatient Prospective Payment System (OPPS) proposed rule on July 14, 2016 (the Proposed Rule). In part, the Proposed Rule addresses CMS’s implementation of Section 603 of the Bipartisan Budget Act of 2015 (Section 603) which significantly limits payment for items...

Healthcare Payment and Reimbursement

November 23, 2015

The Impact of the Bipartisan Budget Act of 2015 on Off-Campus Hospital Outpatient Departments

November 23, 2015 On November 2, 2015, President Obama signed the Bipartisan Budget Act of 2015 (“Act”) into law significantly impacting how Medicare pays certain off-campus hospital departments. Specifically, Section 603 of the Act provides that items and services furnished at off-campus departments of a hospital will not be reimbursed under the hospital outpatient prospective...

OIG Guidance

November 11, 2015

OIG Releases 2016 Work Plan

November 11, 2015 Executive Summary The United States Health and Human Services Office of the Inspector General (“OIG”) published its Fiscal Year 2016 Work Plan (“2016 Plan”) on November 2, 2015. The work plan is published annually by the OIG and identifies new and ongoing investigative, enforcement and compliance priorities for the OIG in the...

Contributors

Andrew Brantingham

Andrew's experience spans a wide range of industries, and has particular depth in...

Rebecca Brommel

Becki assists clients in the areas of litigation and administrative law wit...

Katie Cownie

Katie has worked on business and corporate issues for more than 20 years. Many of...

Lillie Cox

Lillie assists a wide array of healthcare industry clients with corporate transact...

Ross C. D'Emanuele

Ross works in the health care provider, payor, and drug and medical device segment...

Nathan Ebnet

Nate represents clients in all stages of complex civil disputes, from pre-...

Elise Fester

Elise counsels a wide variety of clients in the Health Care industry on regulatory...

Adam Freed

Adam provides strategic advice to health care providers through all stage...

Randall Hanson

Randall is an associate in Dorsey’s health transactions and regulations practice group.

Alan Iverson

Alan is a litigator in Dorsey’s trial group with a focus on clients in...

Michael Jenkins

Mike serves clients in highly regulated industries, including health care and gam...

Jamie McCarty

Jamie counsels clients in the healthcare industry in connection with complex busi...

Laura C.S. Newberry

Neal N. Peterson

Neal regularly advises clients regarding compliance with laws specific to the he...

Mara Sanders

Mara regularly advises clients on matters of state and federal regulatory complia...

Vanessa J. Szalapski

Vanessa's practice focuses on litigation in the healthcare industry, including gen...

Claire H. Topp

Claire works in three diverse sectors – health care, tax exempt organizations,...

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