Compliance

The U.S. Department of Treasury’s Office of Foreign Assets Control (OFAC) and the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) recently announced additional rule amendments intended to continue improving relations between the U.S. and Cuba by allowing even greater commerce and humanitarian efforts between the two countries. These new OFAC  and BIS  rules took effect last week.

On September 12, 2016, the EPA issued its Strategy for Addressing the Retail Sector under RCRA’s Regulatory Framework (Strategy Document), which addresses growing concerns about the application of federal hazardous waste regulations to pharmacies and retail operations. The Strategy Document takes into account practices common to pharmacies (e.g., reverse distribution) that present unique compliance issues…

Roughly $2.95 for each $1 overpaid (plus legal costs and the overpayment) based on an August 24, 2016, U.S. Attorney’s Office press release regarding settlement of State of New York, ex rel. Robert P. Kane v. Healthfirst, Inc. et al case in the U.S. District Court for the Southern District of New York. Defendants previously lost a motion to dismiss this case based, in part, on the fact that defendants actually identified and repaid the overpayments. Specifically, about $1 million in overpayments were presented to the defendants in the form of a spreadsheet in February 2011. Subsequently, defendants repaid the overpayments in more than 30 installments from April 2011 to March 2013. Notwithstanding, the government took the position that, under the False Claims Act, repayment should have been made within 60 days of the date of the claims were identified in the spreadsheet. Defendants argued, among other things, that there was ambiguity about the term “identify” as used in the False Claims Act and that the spreadsheet was merely the first component of an investigation into the overpayments that was ongoing through the repayment process. Almost a year after losing the motion to dismiss, defendants settled the case for $2.95 million.

The Telephone Consumer Protection Act (TCPA), which imposes a penalty of $500-$1,500 per violation for pre-recorded or auto-dialed calls to cell phones, contains two statutory exceptions to liability:

  • where the recipient of the call provided his or her prior express consent to be called, or
  • where the call was placed for an “emergency purpose.”

47 U.S.C. § 227 (b)(1). While much attention has been focused on “consent,” the FCC’s definition of “emergency purpose” has remained relatively untested in TCPA litigation.

That landscape may be beginning to change. The federal district court’s recent decision in the putative class action lawsuit Roberts v. Medco Health Solutions, et al., No. 4:15 CV 1368 CDP (E.D. Mo., July 26, 2016) recognized that consistent with the FCC’s promulgated definition, the emergency purpose exception must be interpreted broadly to cover any calls that may affect the health and safety of a consumer.

The U.S. Dept. of Health & Human Services Centers for Medicare and Medicaid Services (CMS) published a memo (Ref:  S&C: 16-33-NH) Aug. 5, 2016, to state nursing home survey agency directors related to protecting resident privacy and prohibiting mental abuse related to photographs and audio/video recordings by nursing home staff. The memo is a response to recent media reports regarding inappropriate posting to social media of pictures of nursing home residents – namely a disconcerting report by ProPublica detailing 47 incidents in which workers shared photos or videos with friends or the public – these incidents involved both mistreatment of residents and inadvertent disclosure or patient health information. Within 30 days of the memo, surveyors are to implement changes to address these issues.

Backing up electronic health record data may become an important aspect of complying with and mitigating risk under the Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health Act (HITECH) if the U.S. Health and Human Services Office of Civil Rights (OCR) heeds legislators’ recommendations.

Employers often misconstrue the terms “non-exempt employee” and “hourly employee,” leading them to believe the terms are interchangeable. But, not all non-exempt employees are necessarily hourly employees. The Fair Labor Standards Act (FLSA) allows employers to pay their non-exempt employees on a salary basis as long as they meet minimum wage and overtime mandates. Paying certain non-exempt employees on a salary basis may prove a useful tool as healthcare institutions weigh changes in employee compensation practices necessitated by new FLSA regulations (previously discussed).

On April 29, 2016, the Joint Commission released an update (“Update”) providing for the use of text messaging to submit orders for patient care, treatment, or services to the hospital or other health care settings for all accreditation programs. Back in 2011, the Joint Commission believed that the technology necessary to secure contents of a text message, verify the identity of the person sending the message, and retain the original message within the medical record were not readily available, and, therefore, prohibited the use of text messaging to submit orders. However, this has changed as reasonably accessible technology has been developed which mitigates the security and record retention risks the Joint Commission previously identified. In the Update, the Joint Commission said, “effective immediately, licensed independent practitioners or other practitioners in accordance with professional standards of practice, law and regulation, and policies and procedures may text orders as long as a secure text messaging platform is used and the required components of an order are included.”

On April 27, 2016, the Department of Health & Human Services Centers for Medicare & Medicaid Services (CMS) released its proposed rule regarding models for tying professional reimbursement to quality. While this may be great news for providers who enjoy the challenges of tracking and reporting data, these challenges are going to cause problems (namely, reimbursement reductions) for some providers. Regardless of whether providers think this is good or bad, providers should start looking at the proposed regulations now because, as proposed, quality-based payments will be a fact of life for all physicians, mid-levels, CRNAs and groups effective Jan. 1, 2019. The regulations will be published in the May 9, 2016, Federal Register. The comment period will officially start at that time and run through 5 p.m. on June 27, 2016.