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ML Strategies Health Care Preview - Week of February 12th
February 12, 2018 | Blog
This week, the President's FY 2019 budget will be released, and the Administration will spend the next couple of weeks touting its goals. How this activity is received in Congress will play out in various committee hearings, as will issues like drug pricing, which the Administration is closely examining.
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The Administration's Budget Proposal for FY2019
February 12, 2018 | Blog
Today, the White House released its FY 2019 budget proposal, outlining its policy priorities for the fiscal year. In health care, the President's budget focuses on prescription drug pricing and opioid funding.
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The New Extender Timeline
February 8, 2018 | Blog
Based on the most up-to-date information on the budget deal, we have developed a new timeline for the major health care extenders. This new timeline is important because these provisions were once all tied together and now, they are not.
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Mintz’s Health Care Enforcement Defense Group Releases New Qui Tam Update
February 8, 2018 | Blog
Mintz’s Health Care Enforcement Defense Group recently published its most recent Health Care Qui Tam Update. This Update analyzes the 47 health care-related qui tam cases unsealed in August and September 2017.
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CMS Releases Advance Notice and Call Letter for Medicare Advantage and Part D
February 6, 2018 | Blog | By Tara E. Dwyer
Late last week, CMS released the Advance Notice of Methodological Changes for Calendar Year (CY) 2019 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2019 draft Call Letter (Advance Notice and Call Letter).
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February 5, 2018 Continuing Resolution: Health Care Provisions
February 6, 2018 | Blog
Late Monday night (February 5, 2018), the House of Representatives released a continuing resolution to keep the government funded and running until March 23, 2018. This CR includes many health care related provisions, specifically many of the health care “minibus” riders. In the chart below we summarize major health care provisions in this CR specific to the health care minibus.
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ML Strategies Health Care Preview - Week of February 5th
February 5, 2018 | Blog
This week, Congress needs to pass a government funding bill by Thursday. Will we get a final budget deal or another continuing resolution? There are still several important health care programs that need to be addressed as well as health care initiatives that have bipartisan support and could find their way into a deal.
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A Guide to New Jersey's New Limits on Pharmaceutical Industry Payments to Prescribers
February 1, 2018 | Blog
The pharmaceutical industry is facing new limits on payments to prescribers in New Jersey. Earlier this month the state's Division of Consumer Affairs finalized sweeping new rules prohibiting some types of payments and capping others. New Jersey now joins the ranks of other states, like California and Massachusetts, with specific payment prohibitions between manufacturers and prescribers.
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Perspective on DOJ Pivot on FCA Enforcement Policy
January 31, 2018 | Blog | By Laurence Freedman
Two new DOJ policies about False Claims Act enforcement became public last week.
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ML Strategies Health Care Preview - Week of January 29th
January 29, 2018 | Blog
This week, President Trump will deliver his first State of the Union address to a joint session of Congress. Following his speech, both parties will leave town for party retreats where they will discuss priorities for the year ahead.
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New York Executive Budget Proposes Corporate Ownership of Retail Clinics, Tax on Not-for-Profit Health Insurance Conversions
January 25, 2018 | Blog
Last week, Governor Andrew Cuomo unveiled his proposed $168 billion budget for fiscal year 2019, which proposes several changes to New York’s healthcare landscape.
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Mintz Reminds Drug Manufacturers of Looming Deadline to Submit Data to FDA
January 24, 2018 | Blog | By Carrie Roll
Last week, Mintz released an Advisory reminding holders of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) of the February 14, 2018, deadline to submit data to the U.S. Food and Drug Administration (FDA).
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Biosimilar Market Developments Continue Apace in 2018
January 18, 2018 | Blog | By Joanne Hawana
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation's abbreviated marketing pathway for biosimilar products.
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This Year May be a Game Changer for 340B Drug Discount Program, Take Two
January 17, 2018 | Blog
I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed to major changes in how the 340B Program operates.
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In Proposed Regulations CMS Requests Information on Changes to Part D Negotiated Prices
January 16, 2018 | Blog | By Tara E. Dwyer
Today is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations.
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ML Strategies Health Care Preview - Week of January 16th
January 16, 2018 | Blog
Congress has four days to fund the government. The emerging spending deal could include any number of legislative priorities. We will wait and see for signs that a spending deal is close before we start envisioning what a short-term continuing resolution might look like.
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CMS Guidance on Work Requirements for Medicaid Eligibility
January 11, 2018 | Blog
On January 11, 2018, CMS released a Letter to Medicaid Directors outlining guidance that work requirements can be used as a basis for eligibility for certain adult Medicaid beneficiaries through 1115 waivers.
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Azar's Nomination Hearing Highlights Medicare Negotiation of Part B Drug Prices
January 10, 2018 | Blog | By Tara E. Dwyer
On January 9th, the Senate Committee on Finance conducted its nomination hearing of Alex Michael Azar II, President Trump’s nominee for Secretary of Health and Human Services. Under President George W. Bush, Mr. Azar served in HHS, first as general counsel to HHS and then as deputy secretary.
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OIG Reaffirms Permissibility of Certain Gainsharing Arrangements
January 10, 2018 | Blog | By Ryan Cuthbertson
The Department of Health and Human Services Office of the Inspector General (OIG) has issued an Advisory Opinion (Opinion) in connection with a hospital’s gainsharing arrangement (Arrangement) with a designated group of neurosurgeons who perform spinal fusion surgeries at the hospital.
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ML Strategies Health Care Preview - Week of January 8th
January 8, 2018 | Blog
This week, Congress returns to D.C. with 11 days to pass a government funding bill that may touch on issues such as CHIP, the minibus, DACA, and disaster relief. How this all comes together by January 19th will start to play out this week.
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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