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Medicaid Reform: It’s All About Paying Providers
February 22, 2017 | Blog
Health care services cost money. Often times, a lot of money. This fundamental truism captures the challenge facing Congressional Republicans as they consider coverage of low income populations as part of their so-called Repeal and Replace effort.
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Fourth Circuit Permits DOJ to Reject an FCA Settlement, But Punts Decision on Statistical Sampling
February 22, 2017 | Blog | By Brian Dunphy, Laurence Freedman
In a closely watched False Claims Act (“FCA”) case, the Fourth Circuit Court of Appeals decided that the Department of Justice (“DOJ”) has an unreviewable right to object to a proposed settlement agreement between a relator and a defendant when the Government has declined to intervene in the case.
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$5.5 Million HIPAA Settlement Underscores Importance of Audit Controls
February 21, 2017 | Blog
On February 16, 2017, the HHS Office for Civil Rights (OCR) disclosed a $5.5 million settlement with Memorial Healthcare Systems (MHS) for HIPAA violations affecting the protected health information (PHI) of 115,143 individuals. The Resolution Agreement, which can be found here, also contains a detailed corrective action plan (CAP).
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OIG Publishes Online Portfolio Highlighting its Body of Work on Drug Pricing and Reimbursement
February 21, 2017 | Blog
For several years now, the public outcry over the issue of drug pricing and reimbursement has increased in frequency and fervor. At least one government agency wants you to know that it has been listening and wants to help provide the information necessary to forge a solution.
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FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds
February 17, 2017 | Blog | By Benjamin Zegarelli
From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible.
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CMS’s Draft 2018 Call Letter: Minor Updates, but Largely a Continuation of Current Policies
February 15, 2017 | Blog | By Lauren Moldawer
Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2018 Medicare Advantage and Part D Advance Notice and Draft Call Letter (“Draft Call Letter”). For the majority of the letter's provisions, CMS is proposing to continue its current course of action and is refraining from introducing new policies.
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Another Court Agrees That A Difference Of Opinion On Medical Necessity Is Insufficient to Show Falsity Under the False Claims Act
February 14, 2017 | Blog | By Samantha Kingsbury, Laurence Freedman
Last month, the U.S. District Court for the District of Utah joined the AseraCare court and others in finding that a relator cannot successfully allege violations of the False Claims Act (“FCA”) based on a purported lack of medical necessity unless there is an objective standard articulated by Medicare.
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St. Jude Cybersecurity Vulnerability Extended to Provider-Owned Devices
February 9, 2017 | Blog
Earlier this week, the U.S. Department of Homeland Security (DHS) updated a prior advisory revealing cybersecurity vulnerabilities in St. Jude Medical's Merlin@home transmitter. The Merlin@home transmitter is used by patients with St. Jude implantable cardiac devices to wirelessly transmit data from the patient's cardiac device to the Merlin.net Patient Care Network.
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Revised Draft 2018 Medicare Marketing Guidelines Open For Comment
January 26, 2017 | Blog | By Tara E. Dwyer
Last week, CMS published the Revised Draft 2018 Medicare Marketing Guidelines and requested feedback from all interested parties.
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The Newly Updated Common Rule is Here – And On a Collision Course With the 21st Century Cures Act
January 26, 2017 | Blog | By Dianne Bourque
On January 18th, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule updating regulations for the protection of human research subjects, the so-called “Common Rule.”
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Recent HIPAA Enforcement Actions
January 25, 2017 | Blog
The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently announced the first ever settlement related to a Covered Entity’s untimely breach notification in violation of HIPAA.
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Health Care Outlook for 2017 from ML Strategies
January 23, 2017 | Blog
ML Strategies has published its Washington Outlook for 2017, with a collection of materials covering what to expect from the 115th Congress, spanning multiple issues and industries.
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Massachusetts Determination of Need Program – Final Regulations
January 23, 2017 | Blog | By Daria Niewenhous
The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has promulgated final DoN regulations.
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FDA’s Enforcement Priorities Likely to Change in 2017 and Other “Unknowable Knowns”
January 17, 2017 | Blog | By Joanne Hawana
As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post will outline some of our thoughts related to what could face FDA and its various stakeholders as we go forward into the great unknown.
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Grassley Continues To Press CMS on Medicaid Drug Rebate Classifications: What Will Be the Fallout?
January 12, 2017 | Blog
Back in early October, we were all transfixed by the announced Mylan settlement with the U.S. Department of Justice (DOJ) over Mylan’s alleged underpayments of Medicaid Drug Rebates for the EpiPen.
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Beyond the Eleventh Hour: FDA Prepares to Finalize Intended Use Amendments Despite Midnight Rule Relief Act
January 11, 2017 | Blog | By Benjamin Zegarelli
On Monday, FDA issued a final rule to amend FDA’s established definitions of “intended use” for drugs and devices, the primary consideration in determining whether a product is regulated for a particular use and what regulations apply.
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Health Care Enforcement Review and 2017 Outlook: Significant Health Care Fraud and Abuse Civil Settlements and Criminal Resolutions
January 10, 2017 | Blog | By Brian Dunphy, Karen Lovitch , Kevin McGinty
In this final installment of our Health Care Enforcement Review and 2017 Outlook series, we analyze health care enforcement trends gathered from 2016 civil settlements and criminal resolutions of health care fraud and abuse cases. Behind the headlines covering enormous recoveries in 2016, several themes are apparent.
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Health Care Enforcement Review and 2017 Outlook: Significant Regulatory Developments
January 6, 2017 | Blog | By Laurence Freedman, Karen Lovitch
While 2016 marked one of the least productive years in the history of Congress, the same cannot be said of health care enforcement and regulatory agencies. Perhaps motivated by the impending change in administration, these agencies promulgated a number of notable regulations in 2016.
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Health Care Enforcement Review and 2017 Outlook: Major Case Developments
January 5, 2017 | Blog | By Ryan Cuthbertson
Today, my colleagues Laurence Freedman, Samantha Kingsbury, and Karen Lovitch released the latest in our ongoing series reviewing health care enforcement activities in 2016 and their impacts looking forward to 2017.
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Join Mintz and ML Strategies as We Kick-Off Our 21st Century Cures Act Webinar Series
January 4, 2017 | Blog | By Lauren Moldawer
Next Tuesday, January 12th, Mintz and ML Strategies will host the first installment of our three-part series focusing on the 21st Century Cures Act (“Cures Act”). The Cures Act represents significant legislation that will have overarching implications on medical research, product development, and drug and biologic manufacturing.
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