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Join Mintz and ML Strategies for the 2nd Annual Pharmacy Summit

April 3, 2017 | Blog | By Lauren Moldawer

Mintz and ML Strategies will be hosting the 2nd Annual Pharmacy Industry Summit on April 5th and 6th! The Summit will bring together stakeholders and thought leaders from across the industry to discuss legal and policy challenges facing manufacturers, PBMs, payors, pharmacies, and providers.
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States Continue Trend to Reduce Telemedicine Barriers

March 31, 2017 | Blog | By Carrie Roll

In 2016 and now in early 2017, state legislatures and regulatory boards continue to enact laws and rules setting telemedicine practice standards.
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Changes Needed to Stark Law Advisory Opinion Process

March 29, 2017 | Blog

The Stark Law has caused angst for many a physician and many a health care lawyer over the years. The Stark Law has also troubled hospital and health system CEOs looking for ways to align incentives with physicians. Some stakeholders say Congress should do away with the myriad statutes and regulations that comprise the strict liability federal law banning physician self-referral.
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C-THRU’s Proposed Changes to Negotiated Prices – A Demonstration of the Part D Program’s Complexities and Misunderstandings

March 29, 2017 | Blog | By Tara E. Dwyer

As described in last week’s post, Senator Wyden has introduced the C-THRU Act that seeks to require public disclosure of PBM rebate amounts, establish a minimum rebate percentage that PBMs must pass on to Part D and Exchange Plan clients, and intends to change the definition and/or application of “negotiated prices” under the Part D program. 
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FBI Warns of Cybersecurity Risk from FTPs

March 29, 2017 | Blog

Last week, the FBI issued guidance specifically applicable to medical and dental facilities regarding the cybersecurity risk of File Transfer Protocol ("FTP") servers operating in "anonymous" mode. 
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FDA User Fee Hearings Picking Up Steam on Capitol Hill

March 28, 2017 | Blog | By Joanne Hawana

As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C) Subcommittee on Health.
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Government Solidifies Victory Blocking Chicago Hospital Merger

March 28, 2017 | Blog | By Dionne Lomax

The Federal Trade Commission (“FTC”) and the State of Illinois successfully concluded their challenge to the proposed merger of Advocate Health Care and NorthShore University Health System earlier this month.
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Future of the Affordable Care Act and the American Health Care Act

March 23, 2017 | Blog | By Bridgette Keller

This week, in their “Future of the Affordable Care Act” series on our Employment Matters blog, my colleagues Alden Bianchi and Edward Lenz provided an analysis of the major provisions of the American Health Care Act (“AHCA”).
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Wyden’s C-THRU Act – Publicizing PBM Rebate Data

March 21, 2017 | Blog | By Tara E. Dwyer

Last week, Senate Finance Committee Ranking Member Ron Wyden (D- Ore.) introduced the “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017.”
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New York Medical Society Warns Providers to Avoid Percentage-Based Fees

March 21, 2017 | Blog

A series of recoupment letters from the New York State Medicaid Fraud Control Unit (MFCU) to healthcare providers who have management or billing company arrangements based on a percentage of collections has prompted the Medical Society of the State of New York (MSSNY) to warn its members that such arrangements are fraudulent under Medicaid law.
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Cures Act Developments: FDA Proposes Class II Device Exemptions

March 16, 2017 | Blog | By Benjamin Zegarelli

Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions.
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President’s Budget Blueprint Increases Funds For Health Care Fraud Enforcement

March 16, 2017 | Blog | By Brian Dunphy

The President has released a “budget blueprint” for fiscal year 2018. Although there are many aspects of the budget blueprint to digest, several budget items signal that government health care fraud enforcement remains a priority under the new administration.
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New Qui Tam Update from Mintz’s Health Care Enforcement Defense Group - March 2017

March 16, 2017 | Blog | By Ryan Cuthbertson

Earlier this month, Mintz’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update that looks at 18 health care-related qui tam cases unsealed in October and November of 2016.
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Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

March 15, 2017 | Blog | By Theresa Carnegie, Lauren Moldawer

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such models.
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The Uncertain Future of the 340B Drug Discount Program

March 14, 2017 | Blog

Here we are in March 2017 and no one is sure where things stand with the 340B Drug Discount Program. HRSA and its oversight of the 340B program are subject to the recent Executive Orders restricting issuance of federal regulations and the promised repeal of the Affordable Care Act (ACA) has the potential to impact 340B operations.
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Let the 2017 "UFA" Games Begin!

March 14, 2017 | Blog | By Joanne Hawana

In the alphabet soup that is health and FDA law and policy (if you don’t know what we mean, are you sure you should be reading this blog?), one acronym that doesn’t get a lot of respect is “UFA.” This is the first is a series of blog posts that aim to educate and inform our readers about why the UFA acronym matters and how the UFA legislative process may be particularly significant in 2017.
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Provider Payments Under a Medicaid Per Capita Cap

March 14, 2017 | Blog

In a February 24th blog post, we described Medicaid block grants and per capita caps in terms of A x B = C to demonstrate how those payment policies work.  ‘A’ is the amount a state is paid per beneficiary, ‘B’ is the number of beneficiaries in a given state, and ‘C’ is the total state payment from the federal government. 
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Medicare Advisors Debate Part B Drug Payment Reforms

March 10, 2017 | Blog | By Carrie Roll

Last week, the Medicare Payment Advisory Commission (the “Commission”) debated a package of policy reforms that would change the way Medicare reimburses physicians for Medicare Part B drugs.
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Advice to Healthcare Providers on Ransomware from the Head of the FBI

March 10, 2017 | Blog | By Dianne Bourque, Cynthia Larose

On Wednesday, March 8, James B. Comey, Director of the FBI, was at Boston College to deliver the keynote address for the inaugural Boston Conference on Cyber Security (BCCS 2017). 
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Massachusetts Department of Public Health – Final Hospital Licensure Regulations

March 9, 2017 | Blog | By Daria Niewenhous

The Massachusetts Department of Public Health (DPH) has promulgated final Hospital Licensure Regulations.  Approved by unanimous vote of the Massachusetts Public Health Council (PHC) on March 8, 2017, DPH anticipates that the Hospital Licensure Regulations (105 CMR 130.000, et seq.) will be published in the Massachusetts Register in April, 2017.
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