House Judiciary Committee Passes Markup of the Innovation Act
On Wednesday, June 11, the House Judiciary Full Committee held a markup of H.R. 9, the Innovation Act. The bill, introduced by committee Chairman Bob Goodlatte (R-VA) and cosponsored by 26 House members, aims to reduce abusive patent litigations through increased pleading standards and transparency provisions while still protecting legitimate property rights. During the hearing, a Manager’s Amendment was offered by Chairman Goodlatte which sought to address some concerns raised by the drug and biotech industries pertaining to use of the IPR proceeding to engage in market manipulation, as well as addressing the potential for abuse by parties engaging in extortion of patent owners by seeking pay-offs to not file IPR cases. Congresswoman Mimi Walters (D-CA) addressed these concerns more aggressively by offering an amendment that would carve out drug and biologic product patents from being eligible for inter partes review entirely. While Goodlatte strongly opposed including the amendment in the bill, he did offer support to continue working with Walters to ensure the IPR process is not abused, and Walters withdrew the amendment. After all amendments were considered and others withdrawn, a vote commenced on the Innovation Act, as amended, and was passed by a vote of 24- 8. Text of the entire bill can be found HERE. The online webcast of the markup can be found HERE. The Walters amendment can be found HERE.
Medical Device Tax Repeal Vote Expected in the House Next Week
The House Ways and Means Committee approved a bill last week that would repeal the 2.3% medical device excise tax. That legislation currently scheduled to be deliberated on the House floor the week of June 15. H.R. 160, the Protect Medical Innovation Act of 2015, was originally introduced by Representative Erik Paulsen (R-MN) and passed the committee by a 25‒14 vote. Updated text of H.R. 160 can be found HERE.
Senate HELP Committee Holds Hearing on Solutions to Improve Health Information Exchanges
On Wednesday, June 10, the Senate Health, Education, Labor and Pensions (HELP) Committee chaired by Lamar Alexander (R-TN) held a hearing entitled “Health Information Exchange: A Path Towards Improving the Quality and Value of Health Care for Patients.” The hearing featured testimony from various stakeholders in the health care information technology industry and marked the first of a series of hearings seeking ways to improve the electronic health record exchange and interoperability of health IT systems. Senator Richard Burr (R-NC) along with various other senators directed their questions to the witness panel on why the exchange and interoperability of electronic health records (EHR) data is so difficult. Several members of the panel noted limited resources, different business models, and market competition as complex factors that can deter the information exchange process. In the conclusion of the hearing, Chairman Alexander and Ranking Member Patty Murray (D-WA) announced that Senator Bill Cassidy, MD (R-LA) will chair the committee’s next hearing that focuses on improving physician experience with health IT, with Senator Sheldon Whitehouse (D-RI) serving as ranking member. The full hearing can be found HERE.
House Ways & Means Committee Holds Hearing on HHS FY16 Budget Request
On Wednesday, June 10, the House Ways & Means Committee chaired by Congressman Paul Ryan (R-WI) held a hearing on the fiscal year 2016 budget request for the Department of Health and Human Services and the implementation of the Affordable Care Act (ACA). The hearing featured testimony from the U.S. Department of Health and Human Services Secretary Sylvia Burwell, and largely focused on the upcoming Supreme Court decision in King v. Burwell. Chairman Ryan and other members of the committee asked Secretary Burwell how the Administration would respond if the Supreme Court invalidated the subsidies provided for certain customers in federally facilitated exchanges. In response, Burwell testified that if the court rules in favor of the plaintiff, it is the responsibility of Congress and the states to find a solution. She also stated that President Obama would reject any proposals which would repeal the ACA or any of its core elements. The full hearing can be found HERE.
House Drops Medicare Pay-For from Trade Bills; Bills Fail to Advance
On Thursday, June 11 and Friday, June 12, the House & President Obama attempted to secure support for a controversial trade package, H.R. 1314, containing two major sections: the Trade Assistance Adjustment (TAA) program – a program designed to help workers displaced by trade that is typically supported by Democrats; and Trade Promotion Authority (TPA) – a program granting the President the authority to finalize trade agreements with Pacific Rim nations and the European Union, typically supported by Republicans. These programs are usually considered together to create a bipartisan coalition, and their passage is essential to action on other pending trade agreements such as the Trans-Pacific Partnership Agreement (TPP).
The Senate passed H.R. 1314 with a provision paying for the TAA section via sequestration of $700 million in Medicare spending in FY 2024. This offset became increasingly unpopular with House Democrats and some Republicans, which led to an agreement between House Minority Leader Nancy Pelosi (D-CA) and Speaker John Boehner (R-OH) to remove the Medicare provision and insert a new offset regarding stricter tax enforcement. On Friday, the House moved to vote on each section of the bill, TPA and TAA, separately (excluding the Medicare provision). However, the typically staunch Democratic support for TAA imploded when organized unions urged rank and file Democrats to oppose this section. The House failed to pass TAA by a count of 126-302. The House then agreed to the TPA section of H.R. 1314, but without TAA the entire trade package was essentially defeated, thwarting the efforts by Obama and House Leadership. The Senate could take up TPA as a standalone measure, or the House may try again to pass TAA again. For now, the Medicare offset remains in H.R. 1314 due to the failure to pass an amended trade package without the offset on Friday.
Leak Shows Administration Stopped Supporting Drug & Device Pricing Provision in Trans-Pacific Partnership Agreement in December 2014
On Wednesday, June 10, WikiLeaks released a secret December 2014 draft of an annex to the Trans-Pacific Partnership Agreement (TPP) “Transparency Chapter.” The newly released section reveals that the Obama administration is no longer requesting language requiring national health authorities, both foreign and domestic, to consider “competitive market-driven” prices when determining reimbursements for drugs and devices under TPP. However, the leak shows U.S. negotiators are still pressing for language regarding reimbursement rates for drugs and medical devices that “appropriately value” each product’s therapeutic significance. The full document can be found HERE.
GA Health Care Director Testifies before House VA Committee on VA Antidepressant Prescribing and VA Suicide Data
On Wednesday, June 10, the Government Accountability Office (GAO) released the testimony of Randall Williamson, Director of Health Care for GAO, before a House Committee on Veterans’ Affairs Subcommittee on Oversight and Investigations hearing. The testimony addresses GAO’s November 2014 report examining the Department of Veterans Affairs’ (VA) monitoring of veterans with major depressive disorder (MDD) who were prescribed antidepressants, as well as the use of suicide data within the VA. The report found that the VA failed to comply with current clinical practice guideline (CPG) related to treatment of MDD with antidepressants. The report also found that the demographic and clinical data the VA collects on veteran suicides was not always complete or accurate. The GAO Health Care Director’s testimony is available HERE.
PCORI Issues Schedule Cyclical Funding Opportunities for 2015 and 2016
The Patient Centered Outcomes Research institute (PCORI) has issued a chart containing a schedule of its cyclical funding opportunities for 2015 to 2016 under each of its project categories, including Pragmatic Clinical Studies to Evaluate Patient-Centered Outcomes. In addition, the application deadline for the Spring 2015 Cycle of the Pragmatic Clinical Studies funding announcement is Friday, July 31 for research teams invited to submit full applications. The schedule is available HERE.