OSHA issues recommendations for employer safety and health programs

work incident injuri formLast 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.” Continue Reading

Revised Cuba rules allow medical collaboration, ease some pharmaceutical trade

Cuban flag against skyThe 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. Continue Reading

Managing MACRA – Part III: What is an APM?

A stethoscope and American money on a white background - HealthcUnder MACRA, the merit-based incentive payment system (MIPS) automatically applies to an eligible clinician (generally a physician or mid-level – see our previous blog post for details) except in certain circumstances. One of the circumstances in which an eligible clinician is excluded from MIPS is when the clinician participates in an advanced alternative payment model (APM) that meets certain operational, risk and patient/payment volume requirements. Notably, a participant in a qualifying advanced APM receives a 5 percent annual bonus payment from 2019-2024. A participant in an advanced APM who does not meet the patient/payment threshold requirements may still be exempt from MIPS adjustments (although such a partial qualifying advanced APM participant may choose to participate in MIPS) but will not receive the advanced APM bonus. Continue Reading

Managing MACRA – Part II: Does MACRA apply to me?

A stethoscope and American money on a white background - HealthcMACRA is making big changes to Medicare clinician reimbursement, so which clinicians are affected?

Under MACRA, the merit-based incentive payment system (MIPS) automatically applies to an eligible clinician except in certain circumstances. A MIPS Eligible Clinician (defined at 42 C.F.R. §414.1305) is a:

  • physician, including: (1) a doctor of medicine or osteopathy; (2) a doctor of dental surgery or of dental medicine; (3) a doctor of podiatric medicine; (4) a doctor of optometry; and (5) a chiropractor;
  • physician assistant, a nurse practitioner, and clinical nurse specialist;
  • certified registered nurse anesthetist; or
  • group that includes at least one of the clinicians above.

Continue Reading

Managing MACRA – Part I: What is MACRA?

A stethoscope and American money on a white background - HealthcMACRA is the Medicare Access and CHIP Reauthorization Act of 2015. MACRA ends the Sustainable Growth Rate (SGR) formula that has been in place since 1997 (and was the source of decades of legislative fixes to prevent Medicare reimbursement cuts under the SGR). Continue Reading

Husch Blackwell attorneys celebrate Nobel Prize winner

Sir Stoddart

Sir Stoddart

For Husch Blackwell’s Northwestern University grad school alums, Laura Labeots (Ph.D. 1992) and Ed Gamson (Ph.D. 1970), it was a huge thrill to learn that one of their own, a fellow chemist from Northwestern, had won the 2016 Nobel Prize in Chemistry last week. Sir J. Fraser Stoddart, who specializes in Nanotechnology, will be awarded the Nobel this December in Stockholm, Sweden, for his groundbreaking work on “molecular machines.” He and his group have devised molecules that remarkably can do mechanical work, such as lifting and moving other small molecules. 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

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 which are of significant concern given EPA’s enforcement actions during the past few years over similar practices at retail operations like Whole Foods and Wal-Mart.

Husch Blackwell attorneys, Megan Caldwell, Megan McLean and Jonathan Waldron provide the background, regulatory framework and what the proposed regulations could mean to you in a recent legal alert.

Challenge to the doubling of the white collar salary exemption under FLSA

white collarAs most are aware, on May 18, 2016, the U.S. Department of Labor (DOL) released its much anticipated final rule, drastically increasing the salary requirements to qualify as an exempt executive, administrative or professional employee. The DOL estimates that the final rule will extend overtime protections to 4.2 million workers in the first year of implementation and boost wages by $12 billion over the next 10 years. The rule is set to become effective Dec. 1, 2016. Continue Reading

Let’s Stay Together: Negotiating a Successful Joint Technology Development Agreement

Technology -circuit board-144346637An entrepreneurial company may face an early decision as to how it can afford to develop new technology, particularly new technology that does not fit within the technical specialties of that entity. Whether a new company needs to develop a new website, new software, or a compatible piece of technology, that company might consider entering into a contractual alliance with another party to develop that technology. Continue Reading

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

dollar-signiStock_000013001848_LargeRoughly $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. Continue Reading