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September Privacy and Security Updates

September 15, 2016 | Blog

Although National Cyber Security Month isn't until October, September has brought plenty of privacy and security updates that health care companies need to be aware of. In this post, we review guidance from the Office for Civil Rights (OCR) on cyberattacks, describe new state breach notification laws, and highlight the upcoming NIST/OCR security conference.
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Massachusetts Regulatory Overhaul: Hospitals, Clinics, Dialysis Units, and Medical Marijuana – Oh My!

September 15, 2016 | Blog | By Daria Niewenhous

The Massachusetts Department of Public Health (DPH) has released proposed amended regulations for the licensure of hospitals, clinics, and out-of-hospital dialysis units, proposed the rescission of separate birth center regulations, and proposed amended regulations for medical marijuana.
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CMS Proposes Flexible Reporting Under MACRA

September 14, 2016 | Blog

In a blog post last week, CMS acting administrator Andy Slavitt said that physicians will have the ability to choose among several options to report data to Medicare under the new physician payment system ushered in by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
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Medicaid Managed Care for Brain Injury Waiver Populations

September 13, 2016 | Blog

Our colleagues at ML Strategies, Eli Greenspan and Alexander Hecht, recently published an article in HFMA Advisor, the newsletter of the Massachusetts-Rhode Island chapter of the Healthcare Financial Management Association, on the impact of state Medicaid program transitions to managed care on brain injury waiver populations. 
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2018 Notice of Benefits and Payment: Proposed Updates to the HHS Risk Adjustment Model

September 8, 2016 | Blog | By Lauren Moldawer, Tara E. Dwyer

Last week, the Centers for Medicare & Medicaid Services (“CMS”) released its 2018 Notice of Benefit and Payment setting out payment parameters for the Health Insurance Marketplace for upcoming years.
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GAO Report Suggests Discount Coupons Impact Medicare Spending for Part B Drugs

September 7, 2016 | Blog | By Carrie Roll

Last month, the U.S. Government Accountability Office (GAO) released a report in which it found that manufacturer drug coupon programs for privately insured patients could potentially cause the Medicare Part B program to overspend on certain high-cost Part B drugs.
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FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

September 1, 2016 | Blog | By Joanne Hawana , Joseph Lipchitz

On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry.
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ML Strategies Provides Outlooks for Fall & Lame Duck

August 31, 2016 | Blog

Congress returns after Labor Day for a four-week sprint that will likely be centered on funding the government by way of a continuing resolution. Since Congress was last in session, the landscape on a number of health care issues remains unchanged.
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FDA Approves Third Biosimilar Product

August 31, 2016 | Blog | By Joanne Hawana

As we predicted in yesterday’s post, FDA approved a new biosimilar product, Sandoz’s Erelzi (etanercept-szzs), which is a biosimilar to Amgen’s Enbrel (etanercept), on August 30th. The FDA’s decision comes shortly after its Arthritis Advisory Committee voted unanimously in support of approving the biosimilar.
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Biosimilar FDA Approvals on the Horizon As More States Enact Substitution Laws

August 30, 2016 | Blog | By Joanne Hawana

In a sign of growing scientific acceptance and understanding of the biosimilar regulatory pathway, FDA’s Arthritis Advisory Committee (AAC) voted unanimously last month in favor of approving two new biosimilar products – GP2015, Sandoz’s biosimilar to Amgen’s Enbrel (etanercept); and ABP 501, Amgen’s biosimilar to Abbvie’s Humira (adalimumab).
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Mintz Highlights Legal Updates and Trends in Monthly TCPA Digest

August 25, 2016 | Blog

Mintz TCPA & Consumer Calling Practice team has issued its first monthly newsletter with legal updates and trends in this area.  As we have pointed out before, the healthcare industry is not immune from litigation and enforcement based on the Telephone Consumer Protection Act (TCPA).
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Third Circuit Affirms Dismissal of Exclusive Dealing Antitrust Suit Against Hospital and Physician Group

August 25, 2016 | Blog

Last week, in Deborah Heart & Lung Center v. Virtua Health, Inc., the Third Circuit affirmed a lower court’s dismissal of a suit filed by a hospital alleging an illegal exclusive dealing arrangement by a competing hospital and physician group for referrals made by the defendants to a third hospital rather than to the plaintiff hospital.
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Massachusetts Determination of Need Regulation Overhaul

August 24, 2016 | Blog | By Daria Niewenhous

The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has unveiled proposed regulations that constitute an ambitious and, perhaps, long overdue overhaul of the DoN Program regulations.
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Texas Medical Board's Appeal Must Proceed Under Existing Jurisdiction Arguments

August 22, 2016 | Blog | By Bridgette Keller, Dionne Lomax, Carrie Roll

In another procedural defeat for the Texas Medical Board (the “Board”) over its embattled telemedicine rule, last week, a federal judge held that the Board waited too long to request certification of appeal to the Fifth Circuit.
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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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