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Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the Federal Register on November 28, 2017.
On Monday, November 13, our colleagues in the Antitrust Section published an alert on the recent FTC workshop, “Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics.” The workshop, which was held on November 8, 2017, began with two keynote addresses from FTC Acting Chairman Maureen Ohlhausen and FDA Commissioner Dr. Scott Gottlieb.
The release of the House and Senate GOP tax plan this month has left Washington on edge as it comes to grips with the realities of tax reform. However, the elimination of the medical expense tax deduction in the House Republicans' tax reform package stands out above the rest as misguided.
It's all about tax reform in Congress. This week, the House will look to pass its version of tax reform while the Senate begins marking up its package. Meanwhile, the end of the year is fast approaching and there are number of issues, including the health care minibus, that will need to be addressed.
The U.S. Department of Health and Human Services' Office for Civil Rights (OCR) released its October Cybersecurity Newsletter last week with a focus on mobile devices. Given the amount of work conducted on mobile devices (odds are that at least some of you are reading this on a smart phone), the newsletter is practical for many in the health care industry.
The CHIP Reauthorization fight heads to the Senate where it faces an uncertain path forward as neither side can agree on payfors and the Senate Finance Committee focuses in on tax reform. While the Trump Administration is reportedly preparing an executive order that would eliminate the individual mandate, they are in a holding pattern to see if it gets included in the tax reform package.
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 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Quality Reporting Program.
Given the uncertainty in reimbursement from private insurance and government programs such as Medicare and Medicaid, it is important early on to consider how best to land and leverage relationships with key customers and strategic partners.
Earlier this month the House Energy and Commerce Committee's subcommittee on Government Oversight and Investigations held its second hearing on the 340B Drug Discount Program.
As the calendar turns to November, pressure continues to grow in Congress to pass a CHIP extension and address outstanding minibus extenders. Also on the radar is the first open enrollment period under the Trump Administration and the implications this could have for other policy issues.
On October 23, 2017, a company that developed software to track and trace pharmaceuticals filed a complaint against a pharmaceutical distributors trade association that currently dominates the market for such software, alleging a conspiracy to lock up long-term contracts with customers and exclude competition in violation of the Sherman Act and the Virginia Antitrust Act. 
In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice ("DOJ") has been particularly aggressive in using the False Claims Act to pursue recoveries from individuals, health care providers, and drug manufacturers that participate in federal health benefit programs.
Consumers are increasingly turning to health apps for a variety of medical and wellness-related purposes. This has in turn caused greater amounts of data—including highly sensitive information—to flow through these apps. These data troves can trigger significant compliance responsibilities for the app developer, along with significant legal and contractual risk.
As Part of an ongoing series, we have previously provided details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program, Medicare therapy caps, and community health center funding. This post marks the first in an exploratory series illuminating the structure, funding, and outlook of the Special Needs Plans (SNPs).
Last week, ML Strategies released an Advisory providing a comprehensive review of the sweeping health care legislation recently released by the Massachusetts Senate.
Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 23, 2017. The preview discusses the Alexander-Murray stabilization package introduced by Senators Lamar Alexander (R-TN) and Patty Murray (D-WA).
As you take your health app from innovative idea to reality, you will be engaging in a development project that will likely entail the procurement of technology, services and perhaps even content from third parties.
Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 16, 2017. The preview discusses the Administration's decision to stop paying the cost-sharing reductions (CSRs) that plans have been receiving to cover lower-income individuals under the Affordable Care Act.
As a part of our ongoing blog series we have provided details on the structure, funding, and outlook of several expiring health care provisions, that we’ve referred to as the health care minibus. The minibus includes all of the health care extenders left behind from the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
The Massachusetts Department of Public Health (DPH) has provided a much anticipated pathway to enable for-profit entities to operate Registered Marijuana Dispensaries (RMDs). Which enables non-profit entities with a Provisional or Final Certificate of Registration to operate a RMD, or current applicants, to convert to a for-profit Massachusetts domestic corporate entity. 
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