This post was contributed by Erik Flom and Edward Manzo, intellectual property lawyers at Husch Blackwell.   

Companies having inventions to patent should seriously consider filing their patent applications at the U.S. Patent and Trademark Office on or before Friday, March 15th – the “Ides of March.” This is the final day that entirely new applications can be filed and still be treated under the current patent system. There are five, simple reasons why you might want to meet the deadline:

  1. An applicant under the current system is entitled to prove a date of “invention” that is earlier than the application filing date. The earlier the date of invention, the more likely it is that you will be able to overcome some prior art references or to win a priority contest against a later inventor who filed an earlier application.
  2. Because the definition of “prior art” changes under the America Invents Act, prior art that can be cited against patent applications with an effective filing date after March 15, 2013, generally expands in scope. Unless that prior art derives from the applicant, it cannot be overcome except in narrow circumstances. Often, such prior art is not known until it arises in patent litigation. If the patent has an effective filing date before March 16, 2013, then the patent owner can attempt to overcome some of the prior art on the basis of dates of invention.

The Departments of Justice and Health and Human Services released a report last week showing that the government has achieved the highest return on investment in the 16-year history of the Health Care Fraud and Abuse (HCFAC) Program.  According to the report, for every dollar spent on healthcare-related fraud and abuse investigations in the last three years, the government recovered $7.90.

The government recovered $4.2 billion from healthcare fraud enforcement efforts in FY 2012, up from $4.1 billion in FY 2011.  The government continues to focus on reducing fraud and waste in the healthcare system.

“This was a record-breaking year for the Departments of Justice and Health and Human Services in our collaborative effort to crack down on health care fraud and protect valuable taxpayer dollars,” said Attorney General Holder.　 “In the past fiscal year, our relentless pursuit of health care fraud resulted in the disruption of an array of sophisticated fraud schemes and the recovery of more taxpayer dollars than ever before.　 This report demonstrates our serious commitment to prosecuting health care fraud and safeguarding our world-class health care programs from abuse.”

The government also touted the use of fraud-fighting tools authorized by the Affordable Care Act including enhanced screenings and enrollment requirements, increased data sharing across the government, expanded recovery efforts for overpayments and greater oversight of private insurance abuses.  Screening of all 1.5 million Medicare-enrolled providers through the new Automated Provider Screening system began in FY 2012.  The report states that nearly 150,000 ineligible providers have already been eliminated from Medicare’s billing system. 

While union organizing is decreasing in so many other parts of the economy, the healthcare industry remains a target.  The Service Employees International Union in particular continues in its efforts to organize healthcare facilities throughout the United States.  A recent settlement agreement through the NLRB between the University of Pittsburgh Medical Center and the Service…

President Barack Obama signed the American Taxpayer Relief Act of 2012, often called the “fiscal cliff” agreement, on January 2, 2013. Buried in the 59 pages of the act is a seven-line amendment to Section 1870 of the Social Security Act. This section bars recovery of overpayments from providers who are “without fault” and automatically deems a provider to be without fault three years from the year in which the original payment was made (unless there is evidence of fault). The three-year “without fault” limitation provision was enacted in 1972. Without much notice, the fiscal cliff deal extended this to five years.

The push for extension of the limitation began when the Department of Health and Human Service’s Office of Inspector General (OIG) issued a report recommending to the Centers for Medicare & Medicaid Services (CMS) that it pursue legislation to extend the statute of limitations. (See OIG, Obstacles to Collection of Millions in Medicare Overpayments.) This report blamed the time limitations on reopening and recovery of payments (four years and three years, respectively) as the reason why approximately $330 million in overpayments could not be recovered by CMS. The OIG also concluded that CMS’ inadequate guidance and monitoring of contractors was to blame. The Congressional Budget Office (CBO) has issued a report estimating that $500 million would be added to the federal treasury by 2022 as a result of the statute of limitation change. (See CBO, Detail on Estimated Budgetary Effects of Title VI.)

The biggest question for providers is how to deal with this change going forward. The following illustration demonstrates how the three-year limitation period applied: Provider was notified on February 22, 2009, that it had been paid for services provided to beneficiary. On January 2, 2013, the contractor determined that provider was overpaid for these services. If there was no evidence that provider acted fraudulently, this overpayment could not be recovered because under the statute of limitations the right to do so expired on December 31, 2012. Had the contractor determined that the provider was overpaid on any date prior to December 31, 2012, it would have been recoverable. (See Medicare Financial Management Manual, Chapter 3, Section 80.1.) Accordingly, any payments made in 2009 or before were not recoverable as of January 1, 2013.

On January 31, 2013, the Centers for Medicare & Medicaid Services (CMS) announced the health care organizations selected to participate in the Bundled Payments for Care Improvement initiative (“BPCI”).  BPCI was created by the Affordable Care Act (“ACA”) healthcare reform law to assess whether bundling payments for services in a single episode of care can…

On January 17, 2013, the Office for Civil Rights of the U.S. Department of Health & Human Services issued its final rule modifying the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy, security, enforcement, and breach notification rules under the Health Information Technology for Economic and Clinical Health (HITECH) Act. The final rule…

Pediatric critical care transport teams at the Alfred I. duPont Hospital for Children in Wilmington, Delaware participated in a study using iPads to communicate about the patient’s condition prior to and during transport.  The study, which was funded by the Nemours Fund for Children’s Health, found that use of iPads provided better communication between the transport…

The Long-Awaited HIPAA Omnibus Rule was just issued by HHS.

Brown McCarroll is reviewing the  563 page prepublication version of the new HITECH Act rules.  Of importance, there are new requirements for business associates and their subcontractors , as well as significant changes for hospitals and health systems, including provisions requiring changes to the Notice…

Recently, the U.S. Department of Health and Human Services (HHS) announced a settlement with the Hospice of North Idaho (HONI) for potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule.  The settlement, which was for $50,000, is unique because it is the first settlement involving a breach of electronic…