Senators Joe Donnelly (D-IN) and Cory Gardner (R-CO) have re-introduced the bipartisan FDA Regulatory Efficiency Act, which would allow the Food and Drug Administration (FDA) to bring innovative medical devices to market more quickly.
Donnelly stated, “As scientists and innovators across Indiana and our country work to find new cures and therapies, we should be making it easier for them to bring these products safely to those who need them. I’m proud to work with Sen. Gardner on this bipartisan legislation to cut through the red tape at the FDA and safely speed up the approval process.”
The FDA Regulatory Efficiency Act would help the FDA concentrate on high-priority activities by authorizing third parties to approve quality systems of device companies. Authorized third parties could only approve changes that do not involve major technology changes or changes in the use of the product. The legislation would still hold companies accountable for their quality systems, while also helping to alleviate the overwhelmed FDA. Donnelly and Gardner first introduced the legislation in October 2015.
Health Care Reform Notes
Freshman Sen. Todd Young has reached across the aisle in an attempt to find common ground on health care. He recently sent a letter to all Democratic senators urging them to share their views on what’s working and what’s not with the Affordable Care Act. Young is a member of the Senate Health, Education, Labor and Pensions Committee, which will have a key role in shaping the Senate’s version of health care reform.
Congresswoman Jackie Walorski (IN-02) is touting the American Health Care Act (AHCA), as passed in the U.S. House of Representatives, and how it “brings us closer to a better health care system that puts patients first.” Her editorial appeared Sunday in the South Bend Tribune.
Congressman Larry Bucshon, M.D. (IN-08), who sits on the House Committee on Energy and Commerce where he is a member of the Subcommittees on Health, is using his web site to promote the Washington Post’s fact-checking of several recent claims about the AHCA. One is on coverage for those with pre-existing conditions and the other on classification of assault as a pre-existing condition; both claims were deemed untrue.
The federal Health Insurance Tax is an aspect of the Affordable Care Act that poses a threat to businesses across the country. The following letter of concern from Caryl Auslander, the Indiana Chamber’s vice president of federal affairs, was sent to Sen. Joe Donnelly and explains the Chamber’s position on the issue.
As Hoosiers, we are proud that our state has shown strong and sustained economic growth ever since the nationwide recession in 2009. It is our concern that the Federal government is hurting, rather than helping, by enacting policies that harm the employer community, specifically small businesses. In particular, we are deeply concerned by the Health Insurance Tax (or “HIT”) that is embedded in the Affordable Care Act.
This provision ensures that those individuals and businesses that have to turn to private insurance companies for coverage are stuck with a disproportionate share of the costs of the ACA. While the original intent of the HIT was supposed to be paid by the insurance companies, in reality the companies really act only as tax-collecting proxies for the Federal government.
When a consumer cannot avoid purchasing a good or service, they have little or no power to resist price increases imposed by suppliers. And when all of the suppliers are charged the same tax, they all have the same incentive to pass it along to their consumers. Thus the HIT forms a hidden tax on health insurance consumers: The families and small businesses who can’t afford to self-insure.
By some estimates, the HIT will cost more than $500 per family every year. A tax burden like that can place real hardship on a middle-class family, push poor families straight into insolvency, and keep small businesses from being able to hire new workers, reinvest in their company or provide other services to consumers. In a small firm with 80 employees, the hidden HIT alone could cost more than $40,000 a year — well over the state’s per-capita income.
The HIT is a hidden and regressive tax, and bipartisan agreement has been enough thus far to delay its full implementation. But middle-class Hoosiers and small business owners here cannot afford the continued uncertainty. On behalf of 24,000 Chamber members and customers across the state of Indiana, it is our request that you place the permanent elimination of the Health Insurance Tax at the top of your agenda. Its unconditional repeal would be a victory for transparency, good government, and economic opportunity for all.
Thank you for your leadership on this issue and for defending the people of Indiana.
Vice President, Federal Affairs