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HHS Task Force Says Healthcare Cybersecurity is in "Critical Condition"
June 7, 2017 | Blog
Unbeknownst to many, Congress established the Health Care Industry Cybersecurity Task Force in 2015 to address the health care industry's cybersecurity challenges. That Task Force--a combination of public and private participants--released a report last week describing U.S. healthcare cybersecurity as being in "critical condition."
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Healthcare Weekly Preview from ML Strategies - Week of June 5, 2017
June 6, 2017 | Blog
In addition to yesterday's post on the June session of Congress, our colleagues at ML Strategies have provided another weekly preview of Congressional activity for the week of June 5, 2017. The preview includes the upcoming schedule of the House and Senate, along with the looming issues of the American Health Care Act, the health care minibus, and tax reform.
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The Latest in the Epipen Medicaid Drug Rebate Saga – Where Are We Now?
June 6, 2017 | Blog
The latest installment in the ongoing saga over EpiPen Medicaid Drug Rebates came on May 31, 2017, when Senator Charles Grassley issued a press release stating that between 2006-2016 taxpayers may have overpaid for EpiPen by as much as $1.27 billion, “far more” than the announced-but-never-confirmed or finalized $465 million DOJ settlement with Mylan.
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Congress Returns for June Session to Face AHCA, User Fees and More
June 5, 2017 | Blog
Congress returns from its Memorial Day recess to four full weeks of legislative activity. The drama of the American Health Care Act (AHCA) now hangs over the Senate. The House will return to its regular work once they advance the FDA User Fee Reauthorization, with the Senate also having to schedule floor time for the package.
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Therapy Caps: A Minibus Rider
June 2, 2017 | Blog
In a recent post, we provided additional details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program. In this post we will go into detail on the background and outlook for outpatient therapy caps.This is part of our ongoing series on the potential riders on a health care minibus.
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FDA Commissioner Hints at Drug Pricing-Related Initiatives
May 31, 2017 | Blog | By Joanne Hawana
During his first appearance before Congress as FDA Commissioner on May 25, 2017, Scott Gottlieb reported that the Agency is preparing a "Drug Competition Action Plan" that it will unveil in upcoming weeks and months.
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Mintz’s Employment Matters Blog Analyzes Efforts to Shore up MassHealth
May 30, 2017 | Blog | By Lauren Moldawer
Our colleagues on the Employment Matters blog recently analyzed a budget proposal by the Massachusetts Senate that would authorize the Governor to collect additional funds from employers to offset increasing MassHealth costs.
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Seven Takeaways from the ABA National Institute On Health Care Fraud
May 25, 2017 | Blog
On May 17, 2017 the American Bar Association convened its 27th National Institute on Health Care Fraud. I have attended many of the past annual meetings, and always enjoy the presentations and the opportunity to network with colleagues from all sides of the aisle. And I always come away with a few nuggets to share with those who did not attend.
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CBO Greenlights Telehealth Provisions in Senate’s CHRONIC Care Act
May 25, 2017 | Blog | By Carrie Roll
Last week, the Congressional Budget Office (CBO) concluded that a key piece of telehealth legislation, the CHRONIC Care Act of 2017, would not, overall, increase or decrease Medicare spending.
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Trump Administration HHS 2018 Budget
May 24, 2017 | Blog
On May 23, the White House released its 2018 budget proposal, outlining its priorities for the upcoming fiscal year. In health care, the President has proposed cuts to several agencies and programs. The Administration’s annual budget is seen as a statement of policy, not necessarily a legislative proposal certain to become law.
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Hospital and its Clinic Agree to $34 Million Settlement to False Claims Act Allegation that Compensation to Oncologists Violated the Stark Law
May 24, 2017 | Blog | By Laurence Freedman
Last week, the Department of Justice (DOJ) entered into a $34 million settlement with Mercy Hospital Springfield ("Hospital") of Springfield, Missouri, and its affiliate Mercy Clinic ("Clinic").
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Health Care Weekly Preview from ML Strategies - Week of May 22, 2017
May 23, 2017 | Blog
Our ML Strategies colleagues have published a preview for another big week in health care. The American Health Care Act (AHCA) continues to be a big story as the Senate works on its version. This week we watch for updates on these items and how they might impact AHCA discussions.
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CMS Urged To Reverse Obama-Era Biosimilar Reimbursement Policy
May 22, 2017 | Blog | By Theresa Carnegie, Ryan Cuthbertson
A bipartisan congressional effort is underway to convince CMS to reverse its biosimilar reimbursement policy implemented under the Obama administration. We discussed the current reimbursement policy in a March 2016 blog post when CMS initially released the guidance. CMS implemented the controversial guidance as a final rule in October 2016.
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CMS Releases the Proposed Part D DIR Reporting Requirements for 2016
May 18, 2017 | Blog | By Tara E. Dwyer
Yesterday, CMS released the Proposed Part D DIR (Direct and Indirect Remuneration) Reporting Requirements for 2016 and postponed the 2016 DIR Reporting deadline.
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Memorial Hermann’s Use of Patient Name in Press Release Leads to $2.4 Million HIPAA Settlement
May 18, 2017 | Blog
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced another large HIPAA-related settlement last week with Memorial Hermann Health System (Memorial Hermann), the largest not-for-profit health system in southeast Texas.
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ML Strategies Publishes Weekly Preview for the Week of May 15, 2017
May 17, 2017 | Blog | By Samantha Kingsbury
Our ML Strategies colleagues, Eli Greenspan, Katie Weider, and Rodney Whitlock, have published a new edition of the Health Care Weekly Preview. This edition covers upcoming hearings in the House, including one before the House Ways & Means Committee regarding expiring Medicare programs, as well as changes to Medicare’s payment system.
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FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board
May 16, 2017 | Blog | By Joanne Hawana
On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934.
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Ransomware Attack – Quick Facts
May 13, 2017 | Blog | By Dianne Bourque, Cynthia Larose
By now, you may have heard about the global ransomware attacks affecting health care and other organizations throughout the world, in particular the United Kingdom, but also in the United States. The ransomware variant, called “Wanna Decryption” or “WannaCry” works like any other ransomware: once it is inadvertently installed, it locks up the organization’s data until ransom is paid.
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The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2
May 12, 2017 | Blog | By Benjamin Zegarelli
In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy might end up a few years from now.
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MIECHV: A Minibus Rider
May 10, 2017 | Blog
In a recent post we noted that the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program is one of the many potential riders on the health care minibus. In contrast to an omnibus bill, the “minibus” refers to a handful of policy provisions tied together in one piece of legislation.
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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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