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OCR to Increase Investigations of Smaller HIPAA Breaches
August 19, 2016 | Blog
HHS Office for Civil Rights will cast a wider net and increase its investigations into smaller HIPAA privacy breaches starting this month. OCR announced a new initiative to increase its efforts examining breaches that affect fewer than 500 individuals.
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FDA Releases Revised Guidance on Device Modification Policy
August 16, 2016 | Blog | By Benjamin Zegarelli
FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3).
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Medicare to Refine and Expand its Value-Based Insurance Design Model
August 15, 2016 | Blog
On August 10, 2016, the Centers for Medicare and Medicaid Services (CMS) released a memorandum through its Center for Medicare and Medicaid Innovation announcing changes to the Medicare Advantage Value-Based Insurance Design (MA-VBID) model for 2018.
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Latest OCR HIPAA Settlement Provides Lessons for Covered Entities
August 11, 2016 | Blog
Capping off a busy month of HIPAA settlements, on August 4, the Office for Civil Rights (“OCR”) announced a $5.55 million settlement with Advocate Health Care Network (“Advocate”), the largest fully-integrated healthcare system in Illinois.
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Mintz’s Health Care Enforcement Defense Group Publishes New Qui Tam Update
August 5, 2016 | Blog | By Brian Dunphy
Mintz’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update on August 4, 2016. This Update covers 31 health care-related False Claims Act cases that have been unsealed since the last Health Care Qui Tam Update.
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States’ Efforts for Drug Price Transparency Stymied by the Pharmaceutical Industry
August 2, 2016 | Blog | By Carrie Roll
As we previously reported, in 2015 and early 2016, bills and voter initiatives were introduced in several states that would impose drug pricing controls and transparency requirements on pharmaceutical manufacturers.
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OIG Gives Green Light to Hospice Provider’s Payment to Nursing Facilities
August 1, 2016 | Blog | By Lauren Moldawer
Last week, the OIG issued a favorable opinion to a hospice provider seeking to make supplemental payments to skilled nursing facilities. Under the proposed arrangement, the hospice provider would make a supplemental payment to the nursing facility for dual-eligible individuals electing the hospice benefit that would be in addition to and separate from what the managed care organization (“MCO”) pays the nursing facility.
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Mintz BNA Article Discusses PAMA Final Rule
July 28, 2016 | Blog
Expanding on our recent blog post discussing CMS's final rule (the "Final Rule") implementing portions of the Protecting Access to Medicare Act of 2014 related to clinical laboratories, my colleague Karen Lovitch and I published an article in BNA’s Medicare Report entitled CMS Regulations Overhaul Medicare Clinical Laboratory Fee Schedule.
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Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ's Yates Memo
July 27, 2016 | Blog | By Laurence Freedman, Samantha Kingsbury
Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”) Yates Memo.
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New Materials Help Covered Entities Comply with Nondiscrimination Rules
July 25, 2016 | Blog | By Bridgette Keller
Last week, the Department of Health and Human Services (“HHS”) released new materials for covered entities to use to comply with Section 1557, the nondiscrimination provision of the Affordable Care Act. Section 1557.
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FDA Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations
July 22, 2016 | Blog | By Benjamin Zegarelli
In recent years, applications for orphan drug designations have flooded into FDA at a rapid pace, and this year appears to be no exception. Orphan drug applications received by FDA rose by approximately 30% over the previous year in 2009, 2010, 2013, and 2014, with 467 applications submitted in 2014.
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The Emerging HIPAA Security Threat Presented by . . . Pikachu?
July 21, 2016 | Blog | By Dianne Bourque
Health care providers and other HIPAA-regulated entities should take note of the story on our companion blog, Employment Matters, regarding the augmented reality video game craze Pokémon Go.
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Dionne Lomax named Vice Chair of Publications for the AHLA Antitrust Practice Group
July 21, 2016 | Blog | By Theresa Carnegie, Karen Lovitch
Dionne Lomax named Vice Chair of Publications for the AHLA Antitrust Practice Group.
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FDA Releases Draft Guidance on Codevelopment of Therapeutic Products and Screening Tests
July 21, 2016 | Blog
On July 14, 2016, the U.S. Food and Drug Administration (the "FDA") released draft guidance on the co-development of therapeutic products (such as pharmaceuticals) and companion tests that are used to determine if the therapeutic products will be safe and effective.
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FDA Deep Dive: Real Life Implications of FDA NEST Program Explored
July 19, 2016 | Blog
In our Israel Connect Summer 2016 edition we summarized the FDA's post-market surveillance data programs, including the NEST program designed to consolidate and analyze real-world device data once a device is legally commercialized.
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FDA Reorganization Takes on Cancer Moonshot and Other Initiatives
July 15, 2016 | Blog
On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016 State of Union Address.
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OCR Sends Notification Letters to Phase 2 HIPAA Auditees
July 14, 2016 | Blog
On July 12, 2016, HHS's Office for Civil Rights (OCR) distributed an e-mail discussing recent developments in Phase II of its HIPAA audit program.
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CMS Releases Proposed Outpatient Payment System Rule for 2017, Leaving Hospitals Unhappy
July 14, 2016 | Blog
Last week, the Centers for Medicare and Medicaid Services (CMS) released its proposed rule for the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System for 2017.
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D.C. Circuit Strikes a Potential Blow to the Affordable Care Act
July 13, 2016 | Blog | By Lauren Moldawer
Earlier this month, the Court of Appeals for the D.C. Circuit issued its decision in Central United Life Insurance Co., v. Burwell, striking down a Department of Health and Human Services (HHS) rule prohibiting the sale and marketing of “fixed indemnity” plans to consumers who did not otherwise have minimum essential coverage.
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“Your Money or Your PHI”: OCR Releases Guidance on Ransomware
July 12, 2016 | Blog | By Dianne Bourque
On Monday, the Office for Civil Rights (OCR) released important new guidance on ransomware for hospitals and other healthcare providers and finally addressed the question of whether electronic protected health information (ePHI) that has been encrypted on a covered entity’s systems, but potentially not accessed by the hacker, has been breached for HIPAA purposes.
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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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