The National Association of Worksite Health Centers provides its members with information and analysis on legal and legislative issues and developments impacting employer-sponsored onsite health, fitness, pharmacy and wellness centers. If you're interested in getting involved in future activities relating to any of these efforts, please contact Larry Boress at Lboress@nawhc.org.
EFFORTS TO CHANGE THE IRS CODE RELATED TO ONSITE CLINICS
NAWHC is participating in efforts by a coalition of business organizations to change the IRS code as relates to HSAs and the provisions in the code impacting onsite clinics. Among many other areas, the bill proposes to expand the types of services that could be offered through an onsite clinic, as well as to remove the requirement that people with an HSA plan have to pay some "fair market value" for the services they receive in the clinic.
The leadership of NAWHC, as well as the clinic vendor community, were solicited to submit comments and recommendations for the provisions,definitions and language within the proposed bill. A copy of our comments, as well as a draft of the bill, are included below. On March 22, James Gelfand, Senior Vice President, Health Policy for the ERISA Industry Committee (ERIC) briefed the membership and the clinic vendor community on the status of the legislation.
A link to that recording is available for NAWHC members under the "RESOURCES" tab, under "Legal, Tax and Regulatory Issues."
CLIA WAIVER COALITION
Point-of-care testing (“POCT”) is a cornerstone of patient care, and in coming years, will play an increasingly important role in improving patient outcomes and the public health at large. Roughly 80% of POCT facilities are so-called “Certificate of Waiver” laboratories, which include physician offices, health clinics, urgent care centers and other points of care.
In 2008, FDA published guidance rejecting Congressional standards and limiting development of new CLIA-waived diagnostic tests for nearly a decade. In 2016, Congress responded by directing FDA to propose new policies in the form of updated guidance reinterpreting the meaning of “accurate” as part of 21st Century Cures. The law gives FDA until December 2017 to publish draft guidance, and until December 2018 to finalize that guidance following public comment.
NAWHC has joined the Coalition for CLIA Waiver Reform, and entity dedicated to removing unnecessary impediments that are preventing patient access to innovative CLIA-waived point-of-care tests, and preventing providers from giving their patients the best care. With the large number of innovative lab tests now available in an ambulatory setting, there is an need to get the FDA to offer waivers from CLIA , the Clinical Laboratory Improvement Act, in order to allow worksite clinics to expand the testing that can be offered without people leaving the job site. NAWHC has participated in discussions with the FDA this topic and we continue to monitor its development. The most recent letter supporting changes is listed below.
LEGAL AND HEALTH REFORM ISSUES IMPACTING CLINICS
Listed below are articles or presentations related to how clinics are or may be impacted by health care reform proposals and legislation.