Inside (The Beltway)
Scoop – Jennifer Zeitzer
The legislative gridlock continued in Washington as congressional leaders struggled to complete action on several high profile bills ahead of the upcoming Memorial Day recess. Wanting to go home with significant accomplishments that could be highlighted for their constituents, lawmakers spent the last part of May trying to wrap up work on major banking and financial regulatory reform legislation, a supplemental appropriations measure to provide additional funding for operations in Iraq and Afghanistan, and an extension of unemployment benefits and expiring tax breaks. However, escalating partisanship and the ongoing challenge of having to find 60 votes in the Senate to move forward on most bills left congressional leaders with several unfinished items on the “to-do” list. Despite Majority Leader Harry Reid’s threat to keep the Senate in session over the holiday weekend, that chamber failed to reach agreement on the unemployment extension and tax bill.
In addition, tensions over efforts to place strict limits on spending flared up during debate on the war funding measure as Senators Jeff Sessions (R-AL) and Claire McCaskill (D-MO) once again attempted to offer their amendment to cap discretionary spending for three years at fiscal year (FY) 2010 levels and require a two-thirds supermajority to waive the restrictions. According to an analysis by the Center for Budget and Policy Priorities, the Sessions-McCaskill amendment would require “much larger cuts in non-defense discretionary programs than many policymakers understand.” It would bring levels well below those in the Senate’s budget resolution, and compared to Obama’s FY 2011 request, the caps would require cuts in non-defense discretionary programs of $16 billion next year, $41 billion in fiscal 2012, and $33.1 billion in 2013. Two prior votes on this amendment (as part of a bill to renew funding for the Federal Aviation Administration and during the Senate Budget Committee’s consideration of a draft budget resolution) failed by very narrow margins.
With so many unresolved issues crowding the legislative agenda, the four week work period between the Memorial Day and Independence Day recesses will likely be busy. Whether any progress is made on the budget will depend largely on how quickly Congress reaches agreement on those items that did not get done before the break. The outlook for the FY 2011 appropriations process, which thus far has been very uncertain, became even cloudier the week of May 24th when House Majority Leader Steny Hoyer (D-MD) indicated that although negotiations on a budget resolution were ongoing, an agreement was not expected before the Memorial Day recess. Senate Budget Committee chairman, Kent Conrad (D-ND) seemed to take an even longer view regarding the timetable for progress on the budget, saying he hoped to pass his budget resolution by the start of the July 4th recess. Further adding to the confusion, both Conrad and Senator Daniel Inouye (D-HI), chairman of the Appropriations Committee, rejected the option of using a “deeming resolution” that had been previously discussed as a way to establish the spending caps that are necessary to move forward on the spending bills. Press reports indicated that after hearing from Senator Conrad at their weekly caucus meeting, Democrats expressed a willingness to debate a budget resolution on the floor. Producing a budget resolution is more palatable in the Senate because it cannot be filibustered. A “deeming resolution” would require 60 votes to overcome a filibuster.
As a plan took shape in the Senate for moving forward on the budget, the House made little progress in reaching an agreement on its strategy. While some members speculated that action in the Senate may help accelerate progress in the House, Budget Committee chairman John Spratt (D-SC) outlined two alternative options, including passing a one year budget with lower spending levels than were proposed by President Obama in his February request or adopting a “deeming resolution” to start the appropriations process while still writing a separate budget resolution later in the year.
One thing is clear amid the uncertainty – continued debate about the budget resolution will likely mean a further delay in consideration of the individual appropriations bills. Although Representative Hoyer has said he hopes to have all 12 appropriations bills on the House floor in June, Chairman Inouye has established a less ambitious goal of passing all of the Senate bills out of committee by the August recess. Given the delay in getting started on the spending bills, it is virtually certain that Congress will have to adopt a “continuing resolution” to keep government agencies funded through the mid-term elections. Depending on the outcome of November’s elections, Congress could return for a lame-duck session to pass the remaining appropriations bills (probably through an omnibus), or wait until next year to finish their work.
In other news, House Science and Technology Committee chairman, Bart Gordon (D-TN) is continuing his efforts to pass legislation renewing the 2007
America COMPETES Act. On May 19th, by a vote of 261 to 148, the
America COMPETES Reauthorization Act of 2010 failed to secure the number of votes required to pass the House of Representatives. After having been pulled from the House floor May 13th, the reintroduced bill (H.R. 5325) was considered under suspension, a process that prohibits the bill from being further amended and requires passage by two-thirds of voting members. Although the text of the bill was revised to reduce the reauthorization period from five to three years, the original language on open access did not change. As this article went to press, the legislation was tentatively scheduled for another vote in the House sometime on May 28th.
The language on open access that was included in the COMPETES Act renewal comes in addition to two similar bills that were introduced in the House over the last few months.
The Federal Research Public Access Act of 2010 (FRPAA), HR 5253, was introduced on May 6th by Representative Todd Tiahrt (R-KS) with no cosponsors. HR 5253 is identical to the
Federal Research Public Access Act of 2009, HR 5037, released by Representative Mike Doyle (D-PA) on April 15th. Both bills, which would require that peer-reviewed journal articles reporting on federally-funded research be made freely available no later than six months after publication, have been referred to the House Committee on Oversight and Government Reform.
TOP OF PAGE
FASEB Responds to Request for Information on HIPAA Privacy Rule Accounting of Disclosures
In a May 18th
letter to the Department of Health and Human Services (HHS) Office of Civil Rights, FASEB recommended that research be excluded from the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule accounting of disclosures provision. FASEB believes that researchers and research institutions have an obligation to protect the privacy and confidentiality of study participants and their clinical data. However, the federation also expressed concern about the adverse impact that the Privacy Rule has had on health research. Under the accounting of disclosures provision, for example, institutions covered under HIPAA must provide individuals, upon request, a comprehensive list of the disclosures made of their protected health information in the three years preceding the request. The accounting must include the date the disclosure was made, the identity of the individual receiving the information, a description of the information disclosed, and a statement of the purpose of the disclosure. While disclosures made to carry out treatment, payment, and health care operations had initially been excluded from the law, an amendment in the Health Information Technology for Economic and Clinical Health (HITECH) Act, extended the provision to disclosures made through an electronic health record for these reasons.
FASEB’s letter to HHS stated that the accounting of disclosures provision places a prohibitive burden on institutions. Tracking, storing, and communicating the details of each disclosure is costly, and some healthcare providers are reluctant to provide patient data to researchers for this reason. The time, expense, and harm to research associated with this regulation are not offset by added privacy protection, since the accounting is made after the information has been disclosed. Moreover, the Privacy Rule currently requires that investigators demonstrate how they will protect patient privacy before accessing patient data. These matters are also governed by the Common Rule, which mandates that access to data for research purposes be approved by an independent, institutional review board.
Insofar as the accounting of disclosures provision has a negative impact on research and does not enhance the protection of study participants, FASEB recommended the institutions not be required to account for disclosures made for research through an electronic health record or any other means. FASEB believes that both research and study participants would be better served if institutions focused on fully investigating reports that protected health information has been inappropriately disclosed and taking appropriate action if wrong doing is confirmed.
TOP OF PAGE
NIH Issues Long Awaited
Notice of Regulations on Financial Conflicts of
Interest
On May 20th, the National Institutes of Health (NIH) published a
Notice of Proposed Rule Making (NPRM) regarding financial conflicts of interests (FCOI) for researchers engaging in Public Health Service funded research. According to NIH, there are four primary changes introduced in the NPRM. First, investigators will have to disclose all significant financial interests to her/his institution. The institution must then determine if there is a FCOI. Under the current regulations, investigators are the arbiters of what constitutes a FCOI. Second, the
de minimis monetary threshold for “significant financial interest” will be lowered from $10,000 to $5000 per source,
per annum. Exclusions include seminars, lectures, teaching, and service on advisory panels for government or institutions of higher education. Third, institutions will be required to report the value and exact nature (consulting fees, stocks, etc.) of the FCOI to the Department of Health and Human Services. Finally, all institutions receiving Public Health Service funding will be required to post significant FCOI on the web. The research community has 60 days to submit comments. FASEB will continue to follow this issue closely, as well as send a formal statement to NIH about the proposed changes.
TOP OF PAGE
PAGE 1 |
PAGE 2
GO BACK TO MAY 28, 2010
WASHINGTON UPDATE |
