Archives: Compliance

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Don’t miss Emerging Issues in Healthcare Law

Emerging Issues in Healthcare Law is coming to the Big Easy. The American Bar Association’s 18th annual conference is slated for New Orleans March 8-11. Husch Blackwell is a platinum sponsor of this event featuring the most emergent topics facing the healthcare bar. As the industry faces changes and continues to grow under healthcare reform … Continue Reading

St. Clair v. CVS Pharmacy, Inc. and healthcare calls under the TCPA’s emergency purpose exception

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. … Continue Reading

OIG updates policy regarding gifts of nominal value

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 … Continue Reading

EEOC’s targeting of wellness programs and what that means for your company

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 … Continue Reading

Managing MACRA – Part IV: When does it begin?

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 … Continue Reading

OSHA issues recommendations for employer safety and health programs

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 … Continue Reading

Revised Cuba rules allow medical collaboration, ease some pharmaceutical trade

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  … Continue Reading

Recent Regulatory Updates Aimed at Pharmacy (and Retail) Compliance with RCRA

An aisle in a pharmacy. The commercial product(s) or designs displayed in this image represent simulations of a real product, and are changed or altered enough so that they are free of any copyright infringements. Our team of retouching and design specialists custom designed these elements for each photo shoot http://195.154.178.81/DATA/i_collage/pi/shoots/784992.jpgOn 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 … Continue Reading

How much does it cost to identify and repay federal health plan overpayments late?

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 … Continue Reading

Calls and text messages from healthcare organizations: New developments under the TCPA’s ’emergency purpose’ exception

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 … Continue Reading

CMS targets inappropriate social media use in nursing homes

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 … Continue Reading

Congress’ suggestions for ransomware treatment under HIPAA

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.… Continue Reading

Compensating non-exempt employees using the fluctuating workweek method

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 … Continue Reading

Orders can be submitted by text – the Joint Commission update

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 … Continue Reading

CMS’ quest for quality – proposed merit-based and alternative payment model rules released

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 … Continue Reading

Austin becomes first Texas city to “Ban the Box”

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 … Continue Reading

Summary of the final HHS rule for reporting and returning of overpayments

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 … Continue Reading

Adding some class to Information Governance (Part 1)

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 … Continue Reading

CMS to rewrite the rules of EHR meaningful use

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 … Continue Reading

HIPAA compliance: another year older, but hopefully not deeper in debt

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 … Continue Reading

CMS implements first-ever mandatory episode-based bundled payment program for lower extremity joint replacements

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 … Continue Reading

CMS finalizes new timeshare exception to the Stark law

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” … Continue Reading

OIG issues FY 2016 Work Plan with more than 40 new focal areas

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 … Continue Reading
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