Employers should be aware of important year-end action items relating to qualified retirement plans and health and welfare plans.  Husch Blackwell attorney Uche A. Enemchukwu detailed a number of these obligations in an e-alert and noted that some require immediate attention to satisfy the December 2, 2013 deadline.  Other items must be addressed before the…

New research shows that hospitals with higher nursing levels have fewer readmissions and lower penalties for excessive readmission rates.  A new study, which appeared in the October issue of Health Affairs, found that hospitals with higher staffing levels had a 25 percent lower chance of being penalized for readmission rates when compared to hospitals with lower staffing levels.…

When was the last time you thought about your compliance program? As we know, an effective compliance program is important for healthcare companies. It’s also important to review your compliance program periodically and update it according to the latest guidance. OIG guidance and recent Corporate Integrity Agreements (CIAs) are informative about what the OIG is…

Husch Blackwell attorney Joe Geraci weighed in on recent guidance provided by HHS related to whether the federal anti-kickback statute applies to patients who purchase subsidized health insurance products on the new state or federal healthcare exchanges.  Specifically, the anti-kickback regulations apply to “federal healthcare programs” that are defined to include the following:

Any plan

…

Last week, U.S. Senators warned hospitals that higher rates of back surgery may indicate a kickback if the purchase of spinal devices has increased as a result of physician ownership of device distributors.  Senators Orrin Hatch (R-Utah), Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) issued the bipartisan statement based on an HHS report that showed a direct correlation between…

CMS continues to emphasize readmissions as a marker of quality.  CMS research shows that approximately 45% of hospital admissions among those receiving either Medicare skilled nursing services or Medicaid skilled nursing services could have been avoided.  Husch Blackwell attorneys Mark Chouteau and Michael Crowe recently authored an article in the October issue of AHLA Connections…

In late February of this year, an employee at an independent living facility in Bakersfield, California was asked by a 911 dispatcher to begin CPR on an 87-year-old resident.  Despite the 911 dispatcher’s pleas, the employee refused.  The employee was allegedly following a facility policy that, in the event of a health emergency, the staff is to immediately call EMS for assistance and wait with the resident. The residents are informed of and agree to this policy on admission. The resident ultimately passed away.  Although the resident’s family expressed satisfaction with the manner in which the facility handled the situation, the situation generated a great deal of negative publicity. This situation also caused many assisted living facilities (“ALFs”) to question whether they are required to provide CPR. Unlike skilled nursing facilities, ALFs provide a lower level of care to their residents and often do not have nursing personnel on staff 24-hours per day.

The answer to the question of whether an ALF can have a policy like the one at issue in the California situation depends largely on state law.  At least 18 states have explicit laws requiring CPR-trained staff members in ALFs.  Oregon recommends CPR training, but does not require it.  Montana law provides that CPR-trained staff need only be on duty if the facility offers CPR, impliedly authorizing a “no-CPR” policy.  Kentucky is similar but more explicit:  ALFs must train staff on CPR “unless the policies of the [ALF] state that this procedure is not initiated by its staff….” 

As the government shutdown drags on, some CMS activities are grinding to a halt. CMS recently released a memo to State Survey Agency Directors regarding which CMS survey and certification activities will continue and which ones have been put on hold for providers of all types. According to the memo, complaints that are triaged as…

Last week, our own Brian Bewley chaired the HCCA Midwest Regional Conference in Overland Park, Kansas.  The conference addressed current compliance issues such as the compliance officer’s evolving role, RAC audits and appeals, and HIPAA.  The conference had a great turnout – in fact, the most attendees in the conference’s history.

Husch Blackwell’s Julianne Story…

Pfizer, Inc. recently petitioned the Supreme Court, seeking review of three companion decisions from the First Circuit Court of Appeals.  These decisions found against Pfizer and in favor of multiple third-party payors (TPPs)—the Kaiser Foundation Health Plan, Inc. (an HMO), Aetna, Inc. (a health insurer), and a putative class of employer health plans—on civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims for damages suffered due to Pfizer’s fraudulent marketing of off-label uses for the prescription drug Neurontin, an anti-convulsive approved for the treatment of epilepsy.  At the heart of the dispute is causation—the causal chain that runs from a drug manufacturer, such as Pfizer, to third-party payors of prescription drug benefits, such as HMOs, insurers and other health plans.

The First Circuit’s lead opinion—laying the common predicate necessary to understand each of the companion cases—came in the action brought against Pfizer by Kaiser, in which the court affirmed a $142 million jury award to the HMO.

The Development and Marketing of Neurontin

Neurontin was developed during the 1980s and early 1990s as an anti-epileptic drug.  In 1993, the Food and Drug Administration approved Neurontin for treatment of partial seizures in adults with epilepsy.  A campaign to market Neurontin for off-label conditions—conditions not included on the official label approved by the FDA—began in 1995.  These off-label conditions included neuropathic pain (pain from nerve damage), migraine headaches, and bipolar disorder.  Neurontin was marketed for treatment of these off-label conditions by way of, among other things:  (1) direct marketing to doctors, which misrepresented Neurontin’s effectiveness for off-label indications; (2) misleading information supplements and continuing medical education programs; and (3) articles published in medical journals that touted Neurontin’s off-label effectiveness but suppressed negative information about the drug.