Health Care

This week, a high-profile FDA hearing sought to receive broad stakeholder input on four draft guidance documents from 2014 and early 2015 that further explain the agency’s views on some of the criteria for the regulation level of Human Cell and Tissue Products (HCT/P) as well as on the scope of the “same surgical procedure” exception under 21 CFR § 1271.15.

Earlier this week, the U.S. Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) filed an amicus brief with the Fifth Circuit stating that the Texas Medical Board's (the “Board”) appeal was inappropriate and the Court does not have jurisdiction over the appeal.

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.

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.

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).

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. 

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.

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.

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.

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.

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.

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).

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).

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.

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.

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.

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.

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).

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.

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.