States Get Serious About Ethics
As state-level medical device anti-kickback legislation continues to emerge in differing forms across the country, HIA is maintaining a watch and updating our website regarding compliance activities required of manufacturers. State requirements are posted on the HIA website, with an analysis of how requirements impact hearing aid manufacturers (log in and visit "Device Manufacturer Gift & Reporting Requirements" under HIA Issues). The requirements range from limits on gifts or incentives provided to medical or health professionals and annual written compliance declarations (in California) to requisite development and provision of corporate codes of ethics, compliance training, schedules and sanctions (in Massachusetts).
To get a good sense of the states, HIA asked our FDA counsel Hyman, Phelps and McNamara to give us a report on 2010 lawsuits and settlements on the record. The attached chart will provide insight into how deep these actions are, as well as the broad range of activities that the states are targeting.
New Hampshire, North Carolina Insurance Mandates Come Into Effect
January 1 saw hearing aid insurance mandates come into effect in New Hampshire and North Carolina. As reported in the June HIA Update, the two bills were passed within a week of one another. The New Hampshire mandate, (NH HB561) now requires insurers "to cover the cost of a hearing aid for each ear, as needed, as well as related services necessary to assess, select, and fit the hearing aid with a maximum for the hearing aid and related services of no less than $1,500 per hearing aid every 60 months." The law has no age restriction. North Carolina's new mandate set a coverage limit of $2,500 per ear every 36 months, but capped eligibility at 21 years of age. New Hampshire and North Carolina's new laws bring the total of states with hearing aid coverage mandates to 18, a complete list of which can be found here.
Michigan Activists Come Close To Enacting Hearing Aid Tax Credit
Although Michigan hearing health activists were successful in their efforts to convince the state Senate to pass hearing aid tax credit legislation (MI S403), they were disappointed as the year ended without a House vote to adopt the bill. Efforts by activists from HLA-MI, AG Bell-MI and IHS, assisted by HIA, resulted in securing the crucial support of key state Senators and Reps, and the groups are reviewing plans to champion the issue again in the 2011/12 legislative session. Passage would also provide a significant boost for the federal effort given that Michigan is the home of hearing champions including incoming Ways and Means Committee Chairman Dave Camp and Senate Finance Committee Member Debbie Stabenow, both of whom have attended HIA sponsored HLA/AGB/IHS- MI events in support of the federal bill.
