On May 24, 2018, the U.S. Department of Justice announced a $23.85 million settlement with Pfizer, Inc., to settle anti-kickback claims against the company. The settlement arose after an investigation led by U.S. Attorney Andrew Lelling, which looked into the drug industry’s support of patient assistance charities. Pfizer is now…
Wachler & Associates Health Law Blog
Rebranding of the Medicare and Medicaid EHR Incentives Program
On May 7, 2018, the Centers for Medicare and Medicaid Services (“CMS”) released a proposed rule that would rebrand the current Medicare and Medicaid Electronic Health Records (“EHR”) Incentives program into the Promoting Interoperability program (“PI”). The EHR incentives program, created in 2011, encouraged eligible providers to adopt, implement, upgrade…
OIG Issues Report on Toxicology Overpayments
Urine drug testing is medical protocol for patients prescribed opioid drugs in order to monitor compliance and expose possible drug abuse or diversion. In the wake of the opioid crisis, there has been an increase in the frequency and cost of urine drug tests, resulting in a corresponding increase in…
OIG Issues Report on Outpatient PT Overpayments
In March of 2018, the Department of Health and Human Services Office of the Inspector General (OIG) issued a report titled “Many Medicare Claims for Outpatient Physical Therapy Services Did Not Comply With Medicare Requirements” [summary] (the “Report”) identifying millions of dollars of overpayments for outpatient physical therapy services and…
Court Orders AHA to Provide Strategies for Eliminating Medicare Appeals Backlog
On March 22, 2018, the latest development in American Hospital Association (AHA) v. Azar (formerly referred to as AHA v Burwell) emerged as Judge Boasberg issued an order to have the AHA develop strategies to assist the Department of Health and Human Services (HHS) in reducing the Medicare appeals backlog.…
DOJ and Kmart Reach $32.3 Million Settlement to Pharmacy False Claims Suit
On December 22, 2017, the U.S. Department of Justice (DOJ) announced a $32.3 million settlement (the Settlement) with Kmart Corporation, to settle False Claim Act (FCA) allegations against the company. The Settlement was based upon allegations that Kmart’s in-store pharmacies misled government payers by knowingly failing to report discounted prices…
HHS OCR Issues Guidance on Mobile Devices and Compliance with HIPAA
In October 2017, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued Health Insurance Portability and Accountability Act (HIPAA) guidance regarding the use of mobile devices in the healthcare field. The guidance recognizes the risks of mobile device use while also acknowledging the central role…
AHA v Burwell Questioned by DC Circuit Court
On August 11, 2017, a further development came in the Medicare appeals backlog saga, as the D.C. Circuit Court reached a decision on the Department of Health and Human Services’ (HHS’) appeal to the case American Hospital Association (AHA) v Burwell. The decision (“Appeal Decision”) handed down last week was…
OIG Reveals Plans to Scrutinize EHR Incentive Payments
In July 2017, the Department of Health and Human Services Office of Inspector General (OIG) revealed its plans to review the $14.6 billion in incentive payments the Centers of Medicare and Medicaid Services (CMS) made to hospitals between January 1, 2011 and December 31, 2016, pursuant to Medicare’s electronic health…
HHS’ 2nd Update on Appeals Backlog Shows Little Progress
In early June 2017 the Department of Health and Human Services (HHS) issued its second status report on the Medicare appeals backlog. The December 2016 case American Hospital Association v Burwell, in addition to dictating that HHS clear the backlog by 2020, required that HHS release a quarterly status report…