Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
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21st Century Cures: A Closer Look

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

FDA Issues Discussion Paper on LDTs

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more

Alabama CON Report

I. Certificate of Need Program - A. AL2016-035, Bio-Medical Applications of Alabama, Inc. d/b/a - Fresenius Kidney Care Hope Hull, Montgomery, AL: Proposes to construct and operate a new End Stage Renal Disease...more

FDA Takes Action in the Last Days of the Obama Administration to Clarify Some of Its Views on Off-Label Communications

In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more

Are Hybrid Facilities the Wave of the Future?

Seniors Housing Business (www.seniorshousingbusiness.com) recently published a fascinating article on attempts by some senior housing operators to create facilities with a mix of independent living and assisted living...more

Obamacare in the Cross Hairs — but Procedural Hurdles Loom

President-elect Trump and congressional Republicans have promised to “repeal and replace” the Affordable Care Act (ACA), but there is deep division regarding which provisions will be rescinded and around the details of the...more

UK MHRA to develop quality standards for biological medicines

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines....more

MedPAC Votes on Medicare Payment Rate Sufficiency

On January 12, 2017, Medicare Payment Advisory Commission (MedPAC) members unanimously voted to maintain Medicare’s existing updates (i.e., maintain the increases Congress and the HHS Secretary have already established) to...more

Blue Shield Avoids TCPA-Related Liability

A federal court in California recently granted a summary judgment motion filed by Blue Shield of California (“Blue Shield”), allowing it to avoid liability for alleged violations of the Telephone Consumer Protection Act...more

Breaking News – Supreme Court Takes BMS Personal Jurisdiction Case

The United States Supreme Court today granted certiorari in Bristol-Myers Squibb Co. v. Superior Court. Here is a link to the order. The California Supreme Court decision in this case was our worst case for all of 2016. ...more

Unusual Removal Situation Yields Favorable Result

We’re pretty familiar with most diversity-based removal techniques, so when we see something unusual, we sit up and take notice (as we did with removal before service) – then we blog about it. Today’s case is Bahalim v....more

FDA Recommends Maximum Level of Lead in Cosmetic Products . . . But Finds that Most Products Surveyed are Already Well Below the...

As 2016 comes to an end, the Food and Drug Administration (FDA or agency) is turning its attention to cosmetics by issuing a draft guidance on December 21, 2016 recommending a limit of “no more than 10 parts per million (ppm)...more

CFPB Continues Its Focus on Medical Debt

Last week, the Consumer Financial Protection Bureau (CFPB) announced a consent order with two debt collection law firms specializing in medical debt. This action is similar to prior CFPB enforcement actions taken against debt...more

Health Care E-Note - January 2017

On October 4, 2016, The Centers for Medicare and Medicaid Services ("CMS") released the final rules regarding the requirements of participation for skilled nursing facilities. One of the most significant changes to the...more

Alert: FDA Maintains Assigned Unique Suffixes in Generic Names for Biologics

On January 12, 2017, the FDA issued its final guidance on generic naming for biological products submitted pursuant to 351(a) or (k) of the Public Health Service Act. The guidance is titled Nonproprietary Naming for...more

Health Care Reform in Transition While Congress Deliberates

Changes are imminent for the Affordable Care Act and a range of other laws and regulations affecting the health care industry. Ballard Spahr attorneys established a Health Care Reform Initiative in 2008 to monitor and analyze...more

Coherus Announces Positive Topline Phase III Results for its Humira Biosimilar

Coherus Biosciences announced “positive topline 24-week treatment phase three results” in patients with psoriasis for CHS-1420, its proposed biosimilar to Humira® (adalimumab). Coherus stated that it anticipates filing its...more

Potential Implications to the ACA Under the Incoming Republican Administration – Part I: the Insurance Industry

In the uncertain atmosphere surrounding the process of ‘repealing’ and replacing the Affordable Care Act (ACA), there are some clues as to what we can expect to come next, at least with regard with the health insurance...more

CMS Finalizes Revamped Home Health Agency Conditions of Participation

CMS recently issued revamped home health agency (HHA) conditions of participation (CoPs), strengthening patient confidentiality, patient rights, quality assessment, care and performance standards. The final rule was published...more

HHS Finalizes Overhaul of Federal Human Subjects Research Protections

In Depth - On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.”...more

Employment Law - January 2017

California: On-Duty, On-Call Rest Periods Violate State Law - Why it matters - Ruling in a closely watched case, the California Supreme Court declared that on-duty and on-call rest periods violate state law....more

FTC and States Reach $100 Million Antitrust Settlement with Mallinckrodt

On January 18, 2017, the Federal Trade Commission (“FTC”) announced that it reached a $100 million settlement with pharmaceutical company Questcor Pharmaartinceuticals, Inc. and its Irish parent company, Mallinckrodt plc. ...more

Do Routine Calls by Health Plans to Patients and Health Plan Members Constitute “Telemarketing” Under the Telephone Consumer...

Covered entities have a long list of laws and regulations governing their conduct, including their communications with patients, customers, and members. Specifically, the Health Insurance Portability and Accountability Act...more

What Is The Trump Pharmaceutical Policy?

Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump...more

DHS Announces Changes to U.S. & Cuba Migration Policies

On January 12, 2017, the U.S. Department of Homeland Security (DHS) announced changes to the policies and regulations affecting Cuban nationals. DHS stated the “changes represent another important step in the normalization of...more

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