According to a newly released survey by the Massachusetts Medical Device Industry Council (“MassMEDIC”), medical device company executives say the federal medical device excise tax (“MDET”) has hampered industry development, leading to job reductions, reduced research and development spending, and an increased tax compliance burden.
Using Captive Insurance to Create Value for Your Company – Part III
The following is Part III of a six-part series of blog postings regarding whether a captive insurance subsidiary or one owned by the owners or affiliates of a company may represent an effective risk management tool that also provides economic benefits. Although there are various types of captive insurance, this posting and the three to follow will focus primarily on single parent/pure captives and how they might provide economic benefits for you or your healthcare company. Part I and Part II of the blog series are here.
Using captive insurance to create value for your company – Part II
The following is Part II of a six-part series of blog postings regarding whether a captive insurance subsidiary or one owned by the owners or affiliates of a company may represent an effective risk management tool that also provides economic benefits. Although there are various types of captive insurance, this posting and the four to follow will focus primarily on single parent/pure captives and how they might provide economic benefits for you or healthcare business. Part I of this series can be found here.
Using captive insurance to create value for your company
The following is Part I of a six-part series of blog postings regarding whether a captive insurance subsidiary or one owned by the owners or affiliates of a company may represent an effective risk management tool that also provides economic benefits. Although there are various types of captive insurance, this posting and the five to follow will focus primarily on single parent/pure captives and how they might provide economic benefits for you or your healthcare business.
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 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.
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” 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)].
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 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.
DOL may delay implementation of the new FLSA regulations until late 2016
The Wall Street Journal is reporting that the Department of Labor’s new overtime regulations are not likely to be final and implemented until late 2016. As we discussed in prior posts, in June of this year the DOL proposed regulations that would significantly increase the salary basis test for most FLSA exemptions. The proposed change would make several million more employees eligible for overtime payments, which could have a significant impact on an employer’s bottom line. Many commentators and employers were anticipating the new regulations would go into effect either late this year or early 2016. According to the WSJ report, however, the DOL’s Solicitor of Labor, Patricia Smith, recently commented at a labor and employment law conference that the new regulations are not likely to be final before late 2016. According to the report, Ms. Smith noted the DOL received approximately 270,000 comments in response to the proposed regulations and that this, along with the complex nature of the changes, warranted additional time to complete the regulations.
Court strips importation and sale of ‘gray market’ glucose test strips in U.S.
Abbott Labs recently obtained a preliminary injunction prohibiting numerous pharmacies, wholesalers, and other distributors from importing or otherwise using in the U.S. Abbott’s FreeStyle® blood glucose test strips that are intended for sale internationally. Chief Judge Amon of the Eastern District of New York found that Abbott is likely to succeed on the merits of its Lanham Act claim that consumers will likely be confused by the sale of “gray market” FreeStyle test strips in the U.S.
Courts review gene patents
The patentability of genes is under scrutiny all over the world.
Several weeks ago, the High Court of Australia shed light upon the patentability of nucleic acids (D’Arcy v. Myriad Genetics Inc.). Similar to the situation in the U.S. for 35 U.S.C. §101, the High Court found that an isolated nucleic acid coding for a mutant BRCA1 protein was not patentable subject matter.