Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
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House Committee Proposes Relief for Some Off-Campus Provider-Based Departments

On Wednesday May 18, 2016, members of the U.S. House Ways and Means Committee introduced a proposal to continue OPPS payment for those off-campus provider-based departments that were “mid-build” as of November 1, 2015. Under...more

Manatt on Health Reform: Weekly Highlights - May 2016 #4

Uninsurance hit a record-breaking low of 9.1% in 2015; Vermont legislators pass a bill to increase drug formulary and price transparency; and California rolls out its State-funded Medi-Cal expansion to undocumented children....more

New FDA Draft Guidance on the Use of Electronic Health Record Data in Clinical Investigations

FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies. Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more

New ADA and GINA Wellness Regulation Changes Complicate Wellness Program Compliance Analysis and Risks

Wellness programs should all be reviewed considering the Americans with Disabilities Act (“ADA”) and the Genetic Information Nondiscrimination Act (“GINA”) regulatory changes because noncompliance with the new requirements do...more

Connecticut Legislature Passes Non-Compete Act Concerning Contracts With Physicians

On May 18, 2016, the Connecticut legislature transmitted Public Act No. 16-95 (the “Act”) to the Governor for his signature. The Governor is expected to sign the bill into law in the coming weeks. Once he does, it will...more

OPPS Advisory Panel Meeting Set for August 22-23, 2016; CMS Moving to One Panel Meeting Per Year

CMS is hosting its next meeting of the Advisory Panel on Hospital Outpatient Payment (Panel) on August 22-23, 2016. The purpose of the Panel is to advise HHS and CMS on ambulatory payment classification clinical integrity and...more

What's Wellness Got To Do With It?

The EEOC Issues Two Final Rules Regarding Requirements for Employer Wellness Programs under the ADA and the GINA - The EEOC has issued two final rules that clarify when participation in an employer's wellness program is...more

Did You Know … Employers May Provide Limited Incentives to Encourage Participation in Workplace Wellness Programs under EEOC's...

On May 17, 2016, the U.S. Equal Employment Opportunity Commission (EEOC) issued two final rules relating to how employer-sponsored wellness programs may comply with the Americans with Disabilities Act (ADA) and the Genetic...more

North Carolina Legislative Report

Lawmakers returned to Raleigh for the Regular Session April 25, 2016. The MVA Public Affairs Legislative Report on North Carolina will be distributed weekly during session to keep you up to date on the latest legislative...more

EEOC Issues Final Rules Under ADA and GINA on Wellness Programs

The U.S. Equal Employment Opportunity Commission issued two final rules May 16, 2016 that guide employers on the manner with which their wellness programs that ask health-related questions and/or require participants to...more

EEOC Final Rules on Employer Wellness Programs: What Employers Need to Know

Increasingly, more employers are offering workplace wellness programs to promote and encourage healthier lifestyles for their employees and to prevent disease. These programs often involve medical questionnaires, health risk...more

Telemedicine in the UAE

Telemedicine is a product of 20th century information and communication technologies. It is generally defined as the provision of healthcare services from a healthcare professional to a patient from a remote location using a...more

Administration Releases Spring 2016 Regulatory Agenda with Timeline for Rulemaking

The Obama Administration has posted its updated 2016 regulatory agenda, which lists major pending or planned rulemaking and the expected timing for action. The latest agenda includes numerous rules in the pipeline impacting...more

EEOC Finalizes Wellness Program Regulations

The Equal Employment Opportunity Commission has published final regulations and a set of questions and answers on how the Americans with Disabilities Act (ADA) applies to employer-sponsored wellness programs that offer...more

Do surgeons’ (mis)perceptions of risk play too big a role for patients’ good?

A globally renowned seismologist, weary of recent scaremongering reports that a major fault in California was “locked, loaded, and ready to roll,” offered a pointed scientific evaluation of risk: “You’re about as likely to be...more

Supreme Court Considers Circuit Split On The “Implied Certification” Theory Under the False Claims Act

On April 19, 2016, the United States Supreme Court heard oral argument on the viability and breadth of the “implied certification” theory of the False Claims Act (“FCA”). The implied certification theory supports FCA...more

And You Thought RAC Audits Couldn’t Get Any Worse

If there’s one thing that unites the hospital industry—even the fiercest competitors—it’s hatred of audits by recovery audit contractors, or RACs. Why? For one thing, because RACs operate on a contingency fee basis. They...more

OIG Updates Permissive Exclusion Criteria – Suggests Compliance Programs Are Expected

On April 18th, the Office of Inspector General (OIG) issued updated guidance describing the factors it will consider in determining whether to exercise its permissive authority to exclude individuals and entities from federal...more

Health Update - May 2016

Actions to Advance Infant and Early Childhood Mental Health - Editor's Note: Children's earliest experiences—both positive and negative—impact their brain formation and in turn their social and emotional, physical,...more

Federal Court Strikes Down ACA Cost Sharing Reduction Payments

In Depth - A federal district court judge in Washington, DC ruled on May 12, 2016, that Congress did not appropriate funds for the Affordable Care Act’s (ACA) cost-sharing reduction (CSR) subsidies. See United States...more

Also In the News - Data, Privacy, & Security Practice Report - May 2016 #2

K&S Client Alert: Third Try Is A Charm: Defend Trade Secrets Act Of 2015 Enacted Into Law—For the third consecutive year, Congress introduced legislation to create a federal civil cause of action for trade secret...more

USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

Patient and Provider Groups Urge FDA to Institute Meaningful and Memorable Names for Biosimilars

A coalition of patient and provider groups sent an open letter to Leah Christl, FDA’s associate director for therapeutic biologics and biosimilars, urging FDA to use meaningful names for biosimilars instead of random ones. ...more

Court Finds Faulty Funding Provisions in Affordable Care Act Affect Low-Income Affordability Provisions

On Thursday, May 12, 2016, a federal district court judge ruled against the Obama administration, finding that no appropriations have been made to fund payments under Section 1402 of the Affordable Care Act to reimburse...more

Safety Troubles in Hospital Compounding Pharmacies

We wrote yesterday about contamination at the pharmacy of the NIH Clinical Center in Bethesda. Other big hospitals, judging by media reports, also may need to look at their pharmacy operations, especially when they compound...more

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