Latest Articles

The alarming news about potential research misconduct can come in a variety of ways: a negative report in Retraction Watch, an anonymous “Clare Francis” letter, or a tip on the employee hotline. Regardless of the source, every institution must take each allegation seriously, especially if it involves research funded with federal dollars. Not only can a single allegation grow into a full-blown investigation regulated by the Health and Human Services Department’s Office of Research Integrity (ORI),…
The following article was originally published in May 2018 Compliance Today and is reprinted with permission. For years, misconduct in scientific research was policed primarily by the Office of Research Integrity (ORI) at the U.S. Department of Health and Human Services.1 After a lengthy and confidential review, an institution suspected of producing false or fraudulent research was either cleared of the charges or required to issue retractions and pay back any federal grants that had…
In a surprising reversal, last week the U.S. House of Representatives passed legislation that would significantly modify the Affordable Care Act. The legislation, known as the American Health Care Act (the “AHCA”, H.R. 1628), passed on Thursday with a 217-213 party line vote.  After cancelling an expected vote on AHCA in March, the House Republicans developed additional amendments to the AHCA which ultimately led enough House Republicans to support the bill.…
Center for Medicare and Medicaid Services (CMS) issued the long-awaited implementation of the “site-neutrality” provisions of the H.R. 1314 Bipartisan Budget Act of 2015 (BiBA Section 603) on November 1, 2016. The Final Rule will cause new (non-grandfathered) hospital off-campus outpatient departments to no longer be reimbursed under the Medicare Outpatient Prospective Payment System (OPPS). Rather, those locations will receive something less than 50% of the old OPPS rate (at least initially) to approximate Medicare
Proposed Rule Recently, CMS published a Proposed Rule seeking to test a new model for how Medicare pays for drugs and biologicals paid under the Medicare Part B program. With the goals of determining whether alternative drug payment models will result in “better care” and “smarter spending” by reducing Medicare expenditures while enhancing the quality of care, CMS proposed a two phase Part B Drug Payment Model to “test whether alternative payment approaches for Part…
Four years after the issuance of the Proposed Rule and six years after the authorizing statute, CMS has published the much-awaited Final Rule regarding reporting and returning of Medicare Part A and B overpayments (the “Final Rule”). 81 Fed. Reg. 7654-7684 (Feb. 12, 2016).  Since the inception of section 6402(a) of the Affordable Care Act (ACA), there has been confusion among providers, lawyers, regulators, and courts regarding the requirements, scope, and impact of Social Security…
With confirmed Ebola Virus Disease (EVD) patients in the United States, health care facilities and providers should review whether they are compliant with existing laws and recommendations for emergency preparedness. Providers should take the time during non-emergency circumstances to identify issues, make advance legal decisions, and focus on training and education. There is a misperception that liability arises during exigency, but providers risk civil (and even potentially criminal) liability and loss of accreditation if they fail to…
In the hours before everyone began enjoying Labor Day Weekend, the Centers for Medicare & Medicaid Services (CMS) issued an important inpatient hospital review update. To expedite the appeals process and reduce the volume of inpatient status claims currently pending, “CMS is now offering an administrative agreement to any hospital willing to withdraw their pending appeals in exchange for timely partial payment (68% of the net allowable amount).”…