FDA Commissioner Hamburg to Step Down

FDA Commissioner Margaret Hamburg announced that she will step down at the end of March. Dr. Hamburg was nominated by President Obama and confirmed by the Senate in 2009, making her one of the longest serving FDA commissioners of the modern era. During her final year at the agency, the FDA approved 51 new therapies – the most in almost 20 years. Her resignation comes at a time while both the Administration and Congress work to quicken the pace of drug approvals and the development of personalized treatments. The FDA’s chief scientist Dr. Stephen Ostroff will fill Commissioner Hamburg’s post until a new commissioner is named and confirmed by the Senate.

Report Outlines Failures of Mental Health System

The House Energy and Commerce Subcommittee on Oversight and Investigations has released a report from the Government Accountability Office (GAO) entitled “Mental Health: HHS Leadership Needed to Coordinate Federal Efforts Related to Serious Mental Illness.” The GAO found that while SAMHSA is responsible for coordinating mental health services across the federal government, its efforts to lead coordination are lacking. Across the over 100 distinct programs throughout eight federal agencies, the report found inconsistencies and difficulty in evaluating whether patients were successfully served by the programs. GAO recommends that HHS better facilitate inter-agency coordination and that the Department work to identify those programs that most need immediate evaluation.

House Passes Legislation to Repeal and Replace the ACA

For the fourth time, the House has passed legislation to repeal the health care law of 2010. H.R. 596, sponsored by Rep. Bradley Byrne (R-Ala.), would not only repeal the Affordable Care Act (ACA) but would set up a process to draft a replacement for the health insurance law. The bill was largely passed by a party line vote of 239-186, with every Democrat opposing the measure. Three Republicans, Rep. Robert Dold (R-Ill.), Rep. John Katko (R-N.Y.) and Rep. Bruce Poliquin (R-Maine), voted against the bill. Each Republican dissenter holds a seat that was previously occupied by a Democrat and is likely to face a difficult race in 2016. While the House has voted nearly sixty times to repeal or alter the ACA, H.R. 596 marks the first time the legislation has included instructions for ACA replacement. The bill directs the Committee on Education and the Workforce, the Committee on Energy and Commerce, the Committee on the Judiciary, and the Committee on Ways and Means to work together in developing an alternative to the health reform law. The Congressional Budget Office (CBO) was unable to provide an estimate of the budgetary impact of the legislation. In a letter to the House Committee on Rules, CBO Director Douglas W. Elmendorf stated that preparing a score of the legislation would take several weeks, because of the hundreds of provisions in the law that would be repealed which are still in various stages of implementation. In the 10th veto threat of the year, the Obama administration promised that the bill was dead on arrival. President Obama has only issued two vetoes in the first six years of his presidency.

Legislative Proposal to Repeal and Replace the ACA Unveiled

A bicameral Republican plan to repeal and replace the ACA was released by Sen. Richard Burr (R-N.C.), Senate Finance Chairman Orrin Hatch (R-Utah), and House Energy and Commerce Chairman Fred Upton (R-Mich.) last week. The Patient Choice, Affordability, Responsibility, and Empowerment (CARE) Act, based on a similar proposal released last Congress, would do away with both the individual and employer mandate. The proposal would also repeal the ACA’s ban on annual coverage limits by insurers, requirements that plans cover certain services, and rules that mandate the provision of preventative care without out-of-pocket costs for patients. However, the Patient CARE Act would maintain narrower protections for people with pre-existing conditions and would continue to allow young adults to stay on their parent’s plans until age 26. The plan would preserve the ACA’s Medicare cuts for providers such as hospitals, and would also keep health reform’s ban on lifetime limits on insurance coverage. The proposal includes medical liability reforms, and would revise the tax code to cap the exclusion of an employee’s employer-provided health coverage. It would also allow Americans to buy coverage across state lines. In addition to repealing Medicaid expansion, the health reform replacement plan would transition the Medicaid program to a capped allotment. Medicaid beneficiaries would be given tax credits to buy private plans. The Republican replacement proposal would tax workers’ medical coverage if it was valued at more than $12,000 for an individual or $30,000 for a family. The release of the plan comes as Republicans prepare for the Supreme Court decision in King v Burwell, which could eliminate the law’s essential insurance subsidies in states using the federal exchange. Last Congress, then-Sen. Tom Coburn (R-Okla.), Sen. Richard Burr (R-N.C.), and Sen. Orrin Hatch (R-Utah) released a similar proposal.

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