POLICY BRIEFINGS


Energy and Commerce Approves Five Public Health Bills


The House Energy and Commerce Committee approved five pieces of public health legislation last week. The Microbead-Free Waters Act of 2015 (H.R. 1321) would ban cosmetic and beauty products that contain synthetic plastic microbeads. The Medical Controlled Substances Transportation Act (H.R. 3014) would allow registered physicians to transport and administer controlled substances to patients at other practice settings and disaster areas. The Common Sense Nutrition Disclosure Act of 2015 (H.R. 2017) is aimed at providing clarity and flexibility for small businesses subject to menu-labeling requirement regulations. The Ensuring Terminated Providers Are Removed from Medicaid and CHIP Act (H.R. 3716) addresses the problem of health care providers terminated from Medicaid in one state who still participate in Medicaid and CHIP programs in other states. The Medicaid Directory of Caregivers Act (H.R. 3716) would require state Medicaid programs that operate under fee-for-service and/or primary care case management programs include a directory of physicians who served Medicaid patients in the prior 12 months on the Medicaid program’s website. The bills now await consideration by the full chamber.


FDA Releases Report on Laboratory Developed Tests


The Food and Drug Administration (FDA) released a report last week titled The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies. While laboratory developed tests (LDTs) are subject to both the Federal Food, Drug, and Cosmetic Act and the Clinical Laboratory Improvement Amendments, the FDA has historically exercised enforcement discretion towards these tests. In this report, the FDA makes the case for their proposal to increase oversight of LDTs. The report details 20 cases of faulty LDTs that may have caused or have caused harm to patients in the absence of compliance with FDA requirements. In some cases, false positives resulted in unnecessary treatment. In the case of false negatives, LDTs failed to detect potentially life-threatening diseases. Other case study examples provide information with no relevance to the intended disease or condition. During a congressional hearing on the subject, Director of the Center for Devices and Radiological Health Jeffrey Shuren said that he expects the FDA guidance on LDTs to be released by early next year.


Tiberi to Chair Ways and Means Health Subcommittee


Last week, it was decided that Rep. Pat Tiberi (R-Ohio) will take the gavel on the House Ways and Means Health Subcommittee. Tiberi is the fourth-ranking Republican on the committee and will be giving up his chairmanship of the Trade Subcommittee. He lost to Kevin Brady (R-Texas) earlier this month in the race to choose Speaker of the House Paul Ryan’s (R-Wis.) replacement as the chairman of the full committee. Rep. Brady previously chaired the Health Subcommittee. The Subcommittee’s jurisdiction includes the Medicare program and issues dealing with the Affordable Care Act (ACA). Rep. Dave Reichert (R-Wash.) will replace Tiberi as chairman of the Trade Subcommittee.


Bipartisan, Bicameral Request to Eliminate the Cadillac Tax


A bipartisan, bicameral group of lawmakers have written to the President requesting a meeting to discuss the elimination of the “Cadillac Tax.” The 40 percent excise tax on high-cost health insurance plans was included as a part of the Affordable Care Act (ACA) and is set to take effect in 2018. The tax will impact plans with costs exceeding $10,200 for individuals and $27,500 for families. It was meant to restrain health care costs, but both Republicans and Democrats have expressed concerns that it will simply result in the shifting of costs to patients. “In order to avoid hitting the tax, employers are raising deductibles and increasing other out-of-pocket expenses for beneficiaries,” the lawmakers write. “This provision and its impact on American workers is not acceptable.” The members of Congress request a meeting with the President to discuss repeal of the tax as soon as possible. The letter was signed by Sen. Dean Heller (R-Nev.), Sen. Sherrod Brown (D-Ohio), Sen. Martin Heinrich (D-N.M.), Rep. Joe Courtney (D-Conn.) and Rep. Frank Guinta (R-N.H.). Each has sponsored legislation to repeal the tax, which is projected to bring in $91 billion in revenue over ten years.



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