HEALTHCARE LAW NEWS - VOLUME 66
MEDICAID EXPANSION IN INDIANA
Indiana is the 28th state to expand Medicaid under ACA. Indiana received a three year waiver from HHS, and becomes the fifth state to be granted a waiver.
Indiana intendeds to pay for its share of the Medicaid expansion cost beginning in 2017 by assessing hospital fees and cigarette taxes. Nearly 350,000 Indiana residents are expected to qualify under the waiver/expansion plan, and it appears likely that the Indiana plan will be a model for other Republican dominated states.
Some participants could be eligible as soon as February 1, 2015. Those qualifying under the plan are given the option to enroll in their Healthy Indiana, or the broader Healthy Indiana Plus plan (these will commonly be called the Basic and the Plus Plans). The Plus Plan includes dental and visual benefits and more comprehensive prescription drug coverage, and requires enrollees to pay between $3 - $25 a month in to Indiana health savings accounts. There are reductions in costs available in some circumstances for quitting smoking, annual checkups or similar healthy behaviors under this Plan. Those under the federal poverty level do not have to pay these fees, but if they do not, they are required to use the Basic Plan, and make small copayments for care. There are a number of more complicated provisions such as one that excludes people over the poverty level who failed to pay premiums and join the Plus Plan from being in either Plan for six months. These are some of the Plan details which were negotiated between Indiana and HHS before a waiver was granted. Other Indiana requests, such as requiring certain work activities or incentives in order to get coverage were not accepted by HHS, and were removed.
There will be both advocates and critics of Indiana’s approach, as the fifth state to expand through the special waiver program. Critics decry the six month lockout period, while advocates point to the expansion itself being achieved for 350,000 Hoosiers, and the incentives it has to avoid unnecessary use of hospital emergency rooms.
All in all, the three year exemption can be seen as a “test drive” of a Republican advocated Medicaid expansion. It is likely that, depending on the results of the waiver program in Indiana, (and in Arkansas, Iowa, Michigan and Pennsylvania) that this may be the model that is advocated by conservatives as an alternative to the original ACA program.
ANTHEM, UNITED HEALTH ON HIGH
Anthem and United Health, the Country’s two largest insurers are watching their revenues and stock prices rise as a result of ACA. United Health indicated that they added 400,000 new members through the health exchanges during 4Q 2014, and Anthem reported more than 1.8M new enrollees from all business lines in 2014, with 800,000 members enrolled through state Medicaid plans.
Clearly, ACA has been a fountain of earnings and cash for Anthem and United Health.
NEW RULES FOR CLINICAL TRIALS?
FDA reports indicate that the Food and Drug Administration may begin imposing certain requirements for broader patient populations to be used in clinical trials prior to the FDA’s approval of treatments or products. The FDA has indicated that broadening clinical trial participation across more divergent populations is a concern.
These requirements may also affect the rules regarding Medicare and Medicaid coverage of routine care under the Medicare Clinical Trials Policy and the joint policy with Medicaid. If you offer or manage clinical trials, this is an opportunity to work with program sponsors and begin broadening representation of population subgroups ahead of FDA imposed requirements, where appropriate. Obviously, some clinical trials are purposefully limited to certain population subgroups because of the nature of the medicine or the study. Otherwise, the value of the clinical trials will be substantially reduced if there is FDA resistance to approval based upon underrepresented study populations. Note that this FDA action plan follows the recent FDA requirements for the testing of new medical products in pediatric populations.
This newsletter is edited by Paul Wallace of Jones ∙ Wallace, LLC, a member of the American Bar Association Healthcare Law Section and the American Health Lawyers Association who has been representing physicians and healthcare practices for over 25 years. Mr. Wallace assists physicians in health practices in contract items, federal legal compliance, creation of practice entities, estate and wealth planning and similar issues. Please feel free to call if you have any questions on this newsletter or legal matters at (812) 402-1600 or pwallace@joneswallace.com.