Compliance

A California federal court handed down a decision last Friday that may further influence how healthcare entities should approach the Telephone Consumer Protection Act’s (TCPA) “emergency purpose” exception as applied to calls or texts related to patient health and safety. In St. Clair v. CVS Pharmacy, Inc., No. 16-CV-04911-VC, 2016 WL 7489047, at *1 (N.D. Cal. Dec. 30, 2016), the plaintiff alleged that CVS Pharmacy called him multiple times about his prescriptions after he told a customer representative that he no longer wished to be called. CVS moved to dismiss the lawsuit by claiming that all of the calls at issues fell under the emergency purpose exception contained in the statute, and therefore were not subject to the TCPA.

On Dec. 7, 2016, the U.S. Department of Health & Human Services Office of Inspector General (OIG) released an update to its 2000 policy regarding gifts of nominal value given to a Medicare or Medicaid beneficiary. The update increases the nominal value of gifts given to a Medicare or Medicaid beneficiary to $15 per occurrence and $75 in the aggregate for a year (the previous limit was $10 per occurrence and $50 in the aggregate). If a gift complies with these limits, the arrangement does not need to fit within a “safe harbor” to 42 U.S.C. §1320a-7b(b) (the federal anti-kickback statute).

Husch Blackwell was recently named a finalist for the St. Louis Business Journal’s Healthiest Employers 2016 competition. The Business Journal’s profile of Husch Blackwell highlights the firm’s effective use of wellness challenges in the workplace and praises Chris Smith, a partner in our St. Louis office, for his dedicated participation in the wellness initiatives.

Given our firm’s success with health and wellness initiatives, we decided to take this opportunity to discuss and reflect on just a few (of the many) legal requirements relevant to employer wellness programs.

Under MACRA, the merit-based incentive payment system (MIPS) automatically applies to eligible clinicians (generally a physician or mid-level – see our previous blog post for details) and most clinicians who treat Medicare patients are expected to be included in MIPS. As a result, one of the most common questions about MACRA is when it starts. CMS’s final MACRA rule confirms that implementation begins Jan. 1, 2017.

Last week, OSHA published its new “Recommended Practices for Safety and Health Programs,” which advises employers in the healthcare industry and other private sector industries to establish comprehensive internal safety and health programs. The OSHA bulletin also provides extensive guidelines and resources for creating such programs.

In releasing the updated recommendations, OSHA argues that employers adopting such programs could reduce injuries and illnesses and promote sustainability. To the extent that this new guidance creates new compliance burdens and risks (see below), healthcare is likely to be one industry in which OSHA focuses its efforts. After all, OSHA believes that “[m]ore workers are injured in the healthcare and social assistance industry sector than any other.”

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.