Health Care

On October 14, 2014, the United States Supreme Court heard oral arguments in North Carolina State Board of Dental Examiners v. FTC, a U.S. Court of Appeals Fourth Circuit decision upholding an FTC finding that the North Carolina State Board of Dental Examiners (the “Board”) did not qualify for antitrust immunity after excluding non-dentists from providing teeth-whitening services.

Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments to the Anti-Kickback Statute’s regulatory safe harbors (AKS Safe Harbors) and adds protections for increasingly common payment practices and business arrangements under the Civil Monetary Penalty Law (CMP).

The first day of the Supreme Court term saw it decline, without comment, certiorari on two cases raising issues of liability and the sufficiency of pleading under the federal False Claims Act (FCA). 

The Tenth Circuit recently affirmed both class certification and one of the largest verdicts issued in the U.S. this year, denying Dow Chemical Company’s (“Dow”) appeal in a price fixing case related to polyurethane products.

Last week, a Tennessee federal district court judge ruled that government attorneys can extrapolate from a small sample of billing statements to over 50,000 patient admissions by Life Care Centers of America, Inc. (a nursing home operator) to try to hold Life Care Centers liable under the False Claims Act (FCA).

Dionne Lomax and Helen Kim, our colleagues in the Antitrust Practice, have authored an article in Competition Policy International's September 2014 edition of the Antitrust Chronicle observing that, even in the wake of the Affordable Care Act, which is intended to encourage efficiencies in health care delivery to improve health care quality overall.

As a service to our readers we have distilled last week’s joint HHS Office of Civil Rights (OCR) and National Institute of Standards in Technology (NIST) conference, “Safeguarding Health Information: Building Assurance through HIPAA Security” into three phrases: (i) risk assessment, (ii) workforce training, and (iii) adequate encryption.

September 30th marked the launch of transparency reports under the Sunshine Act through a new Open Payments website hosted by the Centers for Medicare & Medicaid Services (CMS).

A False Claims Act suit can be a company’s worst nightmare, as it may potentially result in large settlements and awards on account of the statute’s trebled damages provision.

Earlier this week, my colleague Dianne Bourque commented on a small medical practice’s inability to access its patients’ medical records one July day after its EHR vendor blocked the practice from pulling the data stored in the EHR.

On September 16, 2014, the Centers for Medicare & Medicaid Services (CMS) announced key shared savings and losses results of Accountable Care Organizations (ACOs) that began participating in the Medicare Shared Savings Program (MSSP) or the Pioneer ACO Program (PACO) in 2012 and 2013.

The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released guidance last Wednesday to help covered entities and business associates understand the privacy implications of the 2013 Supreme Court decision in United States v. Windsor (“Windsor”).

Last week CMS announced that it would not execute its option to terminate its 2015 contracts with Medicare Advantage Plans and Part D plans that had scored three stars or less for three consecutive years.

On Wednesday, during a speech before the Taxpayers Against Fraud Education Fund conference in Washington, D.C., Leslie R. Caldwell, Assistant Attorney General for the Department of Justice’s (DOJ) Criminal Division, announced that her office will be stepping up its review of False Claims Act (FCA) qui tam complaints for potential criminal prosecution.

ML Strategies has posted its weekly Health Care Update.  This publication provides timely information on implementation of the Affordable Care Act, Congressional initiatives affecting the health care industry, and federal and state health regulatory developments.

The mobile app and wearables market in health care is booming, most recently evidenced by Apple’s entry into the market with its widely-anticipated “HealthKit,” a purportedly secure platform that allows mHealth apps to share user’s health and fitness data with the new Health app and with each other.

Please join us on September 23rd, 2014 at 1:00 p.m. for a webinar where we’ll discuss the recent statements from the Department of Justice and the U.S. Securities and Exchange Commission describing the susceptibility of pharmaceutical and medical device companies in regards to FCPA enforcement.

As previously reported by the team from ML Strategies, one of the many telehealth developments to watch this year has been the Federation of State Medical Board’s (FSMB) Interstate Licensure Compact. 

The Affordable Care Act (“ACA”) requires that non-grandfathered health plans make preventive care and screenings available to their members at no cost (i.e. no deductibles, coinsurance, or co-payments).

For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations. But things just keep getting murkier.