Compliance

A new ordinance went into effect April 4, 2016, which prohibits many employers in Austin from asking job applicants about their criminal histories until they’re well into the hiring process. The Fair Chance Hiring Ordinance, colloquially known as the “Ban the Box” measure, will forbid most employers from considering an applicant’s criminal record until after making a conditional offer of employment. Thus, Austin employers must evaluate whether the ordinance will affect their operations and, if so, what steps they need to take to alter their hiring processes and related guidelines.

On Feb. 12, the Department of Health and Human Services’ (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) published its final rule regarding reporting and returning Medicare overpayments. This final rule comes nearly four years after its proposed rule regarding the reporting and return of Medicare overpayments that left the provider community nervous and uncertain about when an overpayment would be considered “overdue” under CMS’s vague 60-day standard.

When governing information, it works well to identify and bundle rules (for legal compliance, risk, and value), identify and bundle information (by content and context), and then attach the rule bundles to the information bundles. Classification is a great means to that end, by both framing the questions and supplying the answers. With a classification scheme, we have an upstream “if-then” (if it’s this kind of information, then it has this classification), followed by a downstream “if-then” (if it’s information with this classification, then we treat it this way). A classification scheme is simply a logical paradigm, and frankly, the simpler, the better. For day-to-day efficiency, once the rules and classifications are set, we automate as much and as broadly as possible, thereby avoiding laborious individual decisions that reinvent the wheel.

Recent remarks made by the Centers for Medicare & Medicaid Services (“CMS”) Acting Administrator Andy Slavitt at a healthcare conference indicated that CMS will be ending the “meaningful use” electronic health record (“EHR”) Incentive Program in 2016, five years ahead of its original final end date of 2021. Acting Administrator Slavitt did not elaborate on the specifics of what will replace meaningful use, but stated it would likely be tied to the implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) and would include various streamlined quality reporting programs. MACRA emphasizes a new Merit-Based Incident Payment System and alternative payment models, and according to Acting Administrator Slavitt, this new law warrants a new streamlined regulatory approach to EHR as well.

My New Year’s resolutions will likely be broken early and often in 2016. My consequences are mostly non-monetary: a few more pounds, a little less savings, and not winning the triathlon in my age group. Your consequences, as a HIPAA-covered entity or business associate, for not complying with the Privacy and Security Rules could be much greater, and could put you into serious debt to the HHS Office of Civil Rights (OCR). Therefore, we propose that you resolve now to become fully HIPAA compliant in 2016.

OCR delivered an early holiday gift, wrapped in the Director’s Sept. 23, 2015, report to the Office of Inspector General. In that report, she disclosed that OCR will launch Phase 2 of its HIPAA audit program in early 2016, focusing on noncompliance issues for both covered entities and business associates.

So, grab that cup of hot cocoa and peruse this review of 2014-2015 HIPAA enforcement actions, which should help identify noncompliance issues on which OCR will focus in 2016.

The Centers for Medicare & Medicaid Services (“CMS”) issued its Final Rule on Nov. 16 for the Comprehensive Care for Joint Replacement (“CJR”) model, which mandates that CMS pay providers a bundled payment per episode of care for a Medicare beneficiary undergoing a hip or knee replacement, also referred to as lower extremity joint replacement or LEJR. This marks the first mandated episode-based bundled payment by CMS; all other episode-based bundled payments programs (e.g., Bundled Payment for Care Improvement, or BPCI, initiatives) are voluntary with regard to provider participation. The CJR model will require hospitals in 67 markets to participate in the program initially. A list of the participant hospitals in the selected markets is available here.

In the 2016 Physician Fee Schedule Final Rule published on Nov. 16, 2014, the Centers for Medicare & Medicaid Services (CMS) finalized the proposed exception for timeshare arrangements that we discussed in our earlier blog post [80 Fed. Reg. 70,886, 71,300 (Nov. 16, 2015)]. As we stated in our earlier post, a timeshare or part-time “space use” arrangement typically provides a physician with the use of office space during scheduled time periods. The space usually includes furnishings with basic medical office equipment, supplies and support personnel so that the physician is able to use the space, on a turn-key basis, to see patients during scheduled times. Prior to the implementation of the new timeshare exception, these types of arrangements needed to be structured to comply with the Rental of Office Space Exception, which includes “exclusive use” requirements that many hospitals and physicians found burdensome [42 C.F.R. § 411.357(a)].

The Office of the Inspector General (OIG) for the U.S. Department of Health & Human Services recently published its Fiscal Year 2016 Work Plan, which summarizes OIG’s priorities over the coming year. Notably, the 2016 Work Plan demonstrates the OIG’s expanded focus on delivery system reform and the effectiveness of alternate payment models, coordinated care programs, and value-based purchasing.

There were also noteworthy areas of new focus for several provider types, including skilled nursing facilities, hospice organizations, ambulatory surgical centers, and physician practices.  Below we have highlighted a few key areas from the FY 2016 Work Plan that will likely impact these providers. Please note this is not intended to be a comprehensive summary of the 2016 Work Plan and is focused only on the new OIG focal areas for these certain providers.

The Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) issued a fraud alert on June 9, 2015, targeting physician compensation agreements that potentially violate the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b). The Anti-Kickback Statute prohibits remuneration of payment in exchange for referrals of patients receiving aid from federally funded healthcare programs (i.e. Medicare and Medicaid). The OIG alert references 12 recent settlements with individual physicians who entered into “questionable” medical directorship and office staff arrangements. The key concern in those cases centered on individual physicians entering into arrangements where the compensation did not “reflect [the] fair market value for bona fide services the physicians actually provide[d].”

On August 31, 2015, the Environmental Protection Agency (“EPA”) issued its long-awaited Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule, which is designed to prevent facilities from disposing of hazardous waste pharmaceuticals by flushing them down the toilet or drain. The proposal creates a new subpart under the Resource Conservation and Recovery Act’s (“RCRA”) hazardous waste regulations for the regulation of hazardous waste pharmaceuticals generated by “healthcare facilities” and “pharmaceutical reverse distributors.”