Weekly Washington Healthcare Update - December 15, 2014

1. Congress

   House

   Bill Introduced to Strengthen FDA's Compassionate Use Program

   On Dec. 8, Rep. Michael McCaul (R-TX) introduced a bill that intends to set the foundation for future reforms to the Food and Drug Administration's (FDA) Compassionate Use program by mandating that pharmaceutical companies be transparent in how they make experimental drugs available to certain patients and requiring critical assessments of the program by the Government Accountability Office (GAO) and a stakeholder task force; moreover, the bill would also require the FDA to finalize its May 2013 draft compassionate use guidance for industry and clarify how it interprets and uses adverse drug event data in compassionate use cases. H.R. 5805, the Andrea Sloan Compassionate Use Reform and Enhancement (CURE) Act, was developed on a plan outlined in a white paper released in October. "Across the United States, patients with life-threatening conditions are desperate for treatments that hold the potential to save and prolong their lives. In some extreme cases, experimental drugs or devices may be a patient's only hope when FDA-approved treatments are not available and when patients are unable to enroll in a clinical trial. The Andrea Sloan CURE Act will give patients and doctors upfront information about how to access experimental treatments and provide drug companies more certainty about the compassionate use program." Rep. McCaul said he hopes his bill will be incorporated into a more comprehensive 21st Century Cures package expected to be unveiled by the House Energy and Commerce Committee in January 2015.

   House E&C Subcommittee Holds Hearing to Consider Ways to Increase Cost Savings in Medicare and Medicare

   The House Energy and Commerce Subcommittee on Health held a hearing Dec. 9 to review mounting federal health spending ahead of the 114th Congress. Subcommittee members discussed the escalating spending trajectory of Medicare, Medicaid and the Patient Protection and Affordable Care Act (ACA). The subcommittee also explored opportunities for savings and policy options to strengthen the health care safety net and protect the most vulnerable patient populations. Questions from members and statements from witnesses hinted at future battles over certain provisions of the ACA, including premium assistance in the insurance exchanges and the federal matching rate paid to states as part of the expansion of Medicaid coverage. Health Subcommittee Chairman Joe Pitts (R-PA) commented, "The federal government faces enormous budgetary challenges. Our biggest challenge is mandatory spending, particularly Medicare and Medicaid, which together accounted for 25 percent of all federal spending in FY 2013. These programs need to be strengthened and modernized, not just because millions of Americans depend on them for their health care, but also because out-of-control entitlement spending is crowding out other important priorities."

   Witnesses:

   Panel I

   Mark Miller, Ph.D. Executive Director Medicare Payment Advisory Commission (MedPAC)

   Panel II

   Chris Holt Director of Health Care Policy American Action Forum

   Marc Goldwein Senior Policy Director Committee for a Responsible Federal Budget

   Judy Feder, Ph.D. Professor of Public Policy Georgetown Public Policy Institute

   For more information, or to view the hearing, please visit energycommerce.gov.

   House E&C Looks for Guidance on FDA's Regulations on Laboratory Tests for Draft of Cure Bill

   The House Energy and Commerce Committee released a white paper Dec. 9 seeking stakeholder input on key issues surrounding the Food and Drug Administration's (FDA) divisive plan to regulate laboratory-developed tests (LDT); the white paper solicits ways Congress potentially could step in to shape FDA's and CMS' regulatory roles over LDTs as part of the committee's soon-to-be-released draft 21st Century Cures legislation. In July, FDA notified Congress of its plan to apply the existing medical device classification systems to LDTs and to prioritize regulation of "high-risk" tests, and the agency followed up with formal guidance in October. Of the 11 key regulatory issues addressed in the release, the committee is asking for comments on how the lines between the practice of medicine, the conduct of a diagnostic test and the manufacturing of diagnostic tests should be defined; along with what should comprise a "device" under the Food, Drug and Cosmetic Act subject to FDA regulation versus regulation by CMS. The 21st Century Cures Initiative is a multiyear, collaborative project by Committee Chairman Fred Upton (R-MI) and committee member Rep. Diana DeGette (D-CO) designed to assist in accelerating the pace of cures and medical breakthroughs in the United States in the 21st Century. Stakeholder feedback on the issues raised in the memo is due by Jan. 5, 2015.

   Breast Cancer Early Detection, Newborn Screening Bills Clear House

   On Wednesday, the House passed legislation, H.R. 1281, the Newborn Screening Saves Lives Reauthorization Act, which would extend through FY 2019 a grant program for screening, counseling and other services such as health professional training, related to heritable disorders that can be detected in newborns. Having already passed the Senate with amendment, the bill is cleared for President Obama's signature. And on Tuesday, another bill, H.R. 5185, the EARLY Act Reauthorization of 2014, which would extend through FY 2019 the Young Women's Breast Health Education and Awareness Requires Learning Young Act of 2009, passed the House by voice vote. The EARLY Act supports campaigns to educate the public and health care professionals about young women's breast health, research into prevention of breast cancer in young women and support for young women with breast cancer. Senate consideration is pending.

   Oversight Hearing Examines ACA Implementation, Transparency

   On Dec. 9, the House Oversight and Government Reform Committee held a hearing entitled "Examining ObamaCare Transparency Failures." The hearing allowed members of the committee to hear testimony regarding implementation of the ACA, particularly as it relates to recent concerns over enrollment data, and comments made by an outside consultant who assisted in the development of the health law. CMS Administrator Tavenner explained a mistake her agency made in reporting total ACA enrollment, which had double counted roughly 400,000 dental plans, and discussed her continued focus on health system security and an enhanced consumer experience during this year's ACA enrollment period.

   Witnesses:

   Marilyn Tavenner Administrator, CMS Department of Health and Human Services

   Dr. Jonathan Gruber Professor Massachusetts Institute of Technology

   Mr. Ari Goldmann Independent Contractor

   For more information, or to view the hearing, please visit oversight.house.gov.

   Senate

   Congress Averts Government Shutdown with Passage of "CROmnibus" Funding Measure

   The Senate on Saturday cleared the final hurdle facing a long-term spending bill, passing by a vote of 56-40 a $1.1 trillion package to keep most government operations funded through the remainder of FY 2015. Prior to the Senate vote, the House on Thursday voted 219-206 to pass the spending bill, which consists of an omnibus appropriations bill, combined with one continuing resolution for the Department of Homeland Security. The bill, developed through negotiations among House and Senate leaders, hit a mine field of controversy since its unveiling late Tuesday and nearly failed to pass when many House Republicans refused to back the bill, calling it a vote for amnesty for illegal immigrants because it did not do more to attack President Obama's recent executive order on immigration. House Democrats, whose votes were needed as a result of the Republican defections, revolted over the package's provision rolling back a Dodd-Frank financial reform restriction on banks engaging in derivatives trading. Democrats were also angered by a provision increasing allowable campaign contributions to party committees and a hit against current retiree benefits for those covered by underfunded multiemployer pension plans. Health-related funding in the legislation includes:

   Centers for Medicare and Medicaid Services (CMS): The legislation includes $3.6 billion for CMS management and operations, which is equal to the level put in place by...