Lawmakers Introduce NDAA Amendment to Support New Antibiotic Development

Sen. Michael Bennet (D-Colo.) and Sen. Orrin Hatch (R-Utah) announced that they will introduce the Promise for Antibiotics and Therapeutics for Health (PATH) Act as an amendment to the National Defense Authorization Act (NDAA) for fiscal year (FY) 2017. The bipartisan legislation encourages innovation in antibiotic research and development through the elimination of regulatory obstacles and the creation of a new drug approval pathway. The Food and Drug Administration (FDA) would be allowed to approve an antibacterial drug for a limited patient population if the drug treats a serious condition and addresses an unmet need. The amendment would also call for the implementation of stewardship programs and better surveillance to monitor the threat of antibiotic resistance. The announcement follows Defense Department researchers’ discovery of E.coli bacteria carrying the MCR-1 gene, which makes it resistant to an antibiotic of last resort known as colisitin, in a Pennsylvania woman last week. Sens. Bennet and Hatch stressed that these superbugs are of particular concern to members of the military serving overseas. The PATH Act is supported by the National Military and Veterans Alliance, and many physician, patient, and public health organizations.

ONC Holds Annual Meeting in Washington, D.C.

The Office of the National Coordinator for Health IT (ONC) held its annual meeting in Washington, D.C. last week. During the meeting, former Secretary of the U.S. Department of Health and Human Services (HHS) Kathleen Sebelius lauded the Centers for Medicare and Medicaid Services (CMS) for outpacing the private sector over the past five years on health care delivery and payment reform. The meeting convened stakeholders across the public and private sectors to participate in sessions on patient engagement, precision medicine, interoperability, cybersecurity, telehealth, and many other issues.

Lawmakers Request Raising of Buprenorphine Cap

Twenty-two bipartisan senators have written to U.S. Department of Health and Human Services (HHS) Secretary Sylvia Burwell requesting that HHS raise the cap on the number of patients a provider can treat with medication assisted therapy (MAT) for opioid abuse and addiction. “The current 100 patient cap is one of several factors that have created a huge disparity between those who can prescribe opioids for treatment of pain and those who can prescribe treatments for opioid use disorders,” the senators write. The lawmakers urge HHS to increase the number of patients doctors can treat with buprenorphine from 100 to 500, in line with the Recovery Enhancement for Addiction Treatment (TREAT) Act (S. 1455), advanced by the Senate Health, Education, Labor and Pensions (HELP) Committee last month.

New Members Appointed to MedPAC

The Government Accountability Office (GAO) announced last week that five new members have been appointed to the Medicare Payment Advisory Commission (MedPAC), including Amy Bricker of Express Scripts, Brian DeBusk of DeRoyal Industries, Paul Ginsburg of the Brookings Institution and the University of Southern California, Bruce Pyenson of Milliman, and Pat Wang of Healthfirst. Their terms will expire in April 2019. Jon Christianson of the University of Minnesota was re-appointed and will continue to serve as Vice Chair of the Commission.

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