I have sent today to the so-called “Competition Advocate” for HHS a request to investigate what appears to be a dramatic failure of HHS to follow applicable federal law and regulations regarding full and open competition in its award of the $1 million contract to the Institute of Medicine.
This in some respect duplicates my second request to the Office of Inspector General of HHS, but I thought it would put additional pressure on HHS to have another position within the agency looking into deficiencies in the way this contract was awarded. The Competition Advocate is something like an ombudsman responsible for overseeing the Department’s adherence to the full-and-open-competition requirements of federal contracting law and regulations.
Dear Ms. Griffin,
I am writing to you in your capacity as Competition Advocate for the Department of Health and Human Services (“HHS”) with respect to what appears to be a dramatic failure of HHS to follow applicable federal law and regulations regarding full and open competition in its award of a $1 million contract to the Institute of Medicine (“IOM”) on September 23, 2013 to conduct a study on diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“IOM Contract”). The Statement of Work for the IOM Contract is attached. I have requested the IOM Contract under the FOIA, but have not received it to date.
I have written to HHS’s Office of Inspector General twice with respect to the IOM Contract asking for his investigation of the (1) potential conflict of interest of the IOM regarding its contracted-for study of diagnostic criteria for ME/CFS under the IOM Contract and (2) apparent failure of HHS to follow open-competition requirements in awarding the IOM Contract. My two letters to the Inspector General are attached as well.
On August 27, 2013, a sole-source-solicitation notice was published by HHS on FedBizOpps.gov (attached) without any other announcement by HHS. That notice gave potential vendors only seven (7) days, until September 3, 2013 (one day after Labor Day) to respond, far short of applicable requirements. Following an outcry from the patient population about the proposed contract with the IOM and the woefully inadequate response time, this notice was amended on August 29, 2013 to provide an additional seven (7) days to respond (attached). Later that same day, the notice was again amended to extend the period to respond by one (1) additional day with a revised response date of September 11, 2013 (attached).
On September 4, 2013, the solicitation request was discontinued “[b]ecause of all the of the concern from the public surrounding this potential sole source requisition” (attached). Later on the same day, HHS confirmed the cancellation of the request and stated that “HHS will continue to explore mechanisms to accomplish this work” (attached).
Following this and without further notice other than a message on September 3, 2013 (before the cancellation of the solicitation) from the CFSAC listserv stating that “HHS is actively pursuing a contract with the [IOM]” (attached), HHS entered into the IOM Contract on September 23, 2013.
The Competition in Contracting Act (“CICA”) governs competition in federal procurement agreements, unless the procurement is permitted by a particular statute. No particular procurement statute seems to authorize the IOM Contract. Therefore, CICA applies to the IOM Contract. Under CICA, “full and open competition” requires that “all responsible sources are permitted to submit sealed bids or competitive proposals.”
Under CICA, any procurement contract entered into without full and open competition is non-competitive. In order not to be in violation of CICA, one of seven exceptions allowing HHS to use procedures that are not competitive must apply to the procurement.
Only One Responsible Source and No Other Services Available
A secondary source, USA Spending (attached), indicates that HHS relied on the first exception to the competitive-bid requirements as set forth in 10 U.S.C. § 2304(c)(1) and 41 U.S.C. § 253(c) (single-source contract). None of the other seven exceptions would seem applicable here. However, in order for HHS to be permitted to enter into a non-competitive procurement contract under that first exception, HHS must (1) demonstrate not only that the services are available from only one responsible source, but also that no other type of service satisfies the agency’s needs, (2) in case of contracts over $650,000 such as the IOM Contract, (a) provide written justification for the use of non-competitive procedures as well as (b) obtain approval from your office for using non-competitivprocedures, (3) post the justification and approval within 14 days of contract award and (4) post the procurement notice before contract award.
In my requests to the Office of Inspector General dated November 11, 2013 and November 16, 2013, I set forth the basis for my conclusion that the reliance by HHS on the sole-source justification was unwarranted in light of the readily available alternative of an ad hoc committee of ME/CFS experts, HHS representatives and ME/CFS patient representatives that could develop diagnostic criteria for ME/CFS, similar to what has been done with the Panel on Antiretroviral Guidelines for Adults and Adolescents, a working group of the NIH Office of AIDS Research Advisory Council, which provides regular updates on HIV treatment recommendations.  Given the broad consensus among ME/CFS experts, such an ad hoc panel could relatively easily and expeditiously approve diagnostic criteria for ME/CFS to replace the outdated and discredited Fukuda definition without the delays, expense, conflict-of-interest and non-competition issues represented by the IOM Contract. This, unlike the IOM Contract, would be in line with the October 2012 CFSAC recommendation to hold a case-definition workshop with ME/CFS experts, advocates and patients.
It is obvious that HHS did not, in fact, seriously explore this or other alternatives to the IOM Contract despite its assurances made to the public on September 4, 2013 that it “will continue to explore mechanisms to accomplish this work,” a seeming misrepresentation because on the day before, September 3, 2013, it announced it was actively pursuing a contract with the IOM, and, in fact, awarded the contract to the IOM on September 23, 2013. To my knowledge, there is no public indication of any consideration by HHS of the viable alternative described above or any other means of satisfying HHS’s needs supposedly to be fulfilled by the IOM Contract.
Furthermore, a “responsible source” under CICA is a prospective contractor who, among other requirements, has the necessary experience. The IOM itself acknowledges that it is not experienced in developing case definitions or diagnostic criteria for particular diseases. In fact, according to Dr. Kenneth Shine, former president of IOM and chair of the current IOM committee tasked with the development of a case definition for Chronic Multisymptom Illness” (formerly Gulf War Illness), developing disease definitions is such “a unique task” for the IOM that that Dr. Shine “could not recall when the IOM was last charged with defining a disease.”
Written Justification and Approval and Publication of Both
Under CICA, HHS must justify any non-competitive procurements in writing and certify the accuracy and completeness of its justification. Moreover, the justification must be approved by your office.
The justification and the approval are to precede the contract award, unless HHS relies on the second exception, the unusual-and-compelling-urgency exception, but, even in that case, HHS must have determined the existence of the unusual and compelling urgency prior to awarding the contract. However, HHS may not cause unusual and compelling urgency by poor planning, such as waiting until the end of the fiscal year to procure services and, as a result, claiming unusual and compelling urgency because its appropriations are about to expire. HHS entered into the IOM Contract on September 23, 2013, just 7 days before the end of its fiscal year on September 30, 2013. Therefore, HHS would not have been able to rely on the second exception and, in any event, it seems that it indeed did not do so.
Therefore, HHS was required to provide the written justification and obtain the approval of your office before September 23, 2013, unless HHS’s head determined that the public interest warranted the use of non-competitive procedures, in which case, HHS’s head would have had to document the existence of such circumstances in writing and notify Congress accordingly, which does not seem to have occurred.
To my knowledge, no written justification by HHS or approval by your office of the sole-source nature of the IOM Contract was published on FedBizOpps.gov or on HHS’s website to this date of the IOM Contract, much less within the required 14-day limit (by October 7, 2013). I have spent a considerable amount of time looking for both the justification and approval on FedBizOpps.gov and HHS’s website and wasn’t able to find either, so I am assuming neither was published on either site. If it is impossible for a member of the public, like myself, to find this information, then it is not public even if it were located somewhere on these websites, but buried in such a way to make it impossible to find.
Therefore, I have to assume that neither the justification nor the approval exist or has been published as required. This leads one to speculate that the written justification does not exist and/or that the required approval from your office was not obtained.
Procurement Notice on FedBizOpps.gov
According to CICA, HHS is also required to publish a procurement notice on FedBizOpps.gov announcing requests for proposals for contracts exceeding $25,000. The IOM Contract is for more $1 million. Notice on FedBizOpps of the solicitation for the IOM Contract was therefore required. Moreover, under CICA, HHS may not issue solicitations earlier than 15 days after the publication of the notice or establish a deadline for submission of bids or offers earlier than 30 days after issuance of the solicitation.
Again, I was unable to locate any procurement notice for the IOM Contract on FedBizOpps.gov. The only notices that are published on FedBizOpps.gov regarding an HHS contract with the IOM on the diagnostic criteria for ME/CFS is the cancelled notice originally posted on August 27, 2013 and modified numerous times. However, as that notice was cancelled on September 4, 2013, it does not satisfy the CICA requirements for the IOM Contract. Moreover, even that cancelled sole-source solicitation did not comply with the federal lead-time requirements for sole-source solicitations. Although steps in an apparent attempt to remedy that situation were taken by repeated amendments/modifications to the initial solicitation notice, even these fell far short of the applicable 30-day requirement.
Ms. Griffin, it seems as if there has been a total disregard of the competition requirements for federal contracts by HHS in many respects regarding the IOM Contract, as laid out above. This is particularly astounding given (1) the availability of a superior alternative recommended by CFSAC and (2) the tremendous controversy surrounding the IOM Contract, which would lead one to expect that HHS would take extraordinary measures to ensure that it conduct all steps relating to the award of the IOM Contract in accordance with all applicable rules. These numerous potential violations of federal law appear to fall squarely within your jurisdiction.
I therefore request that you investigate this matter as one of extreme importance and urgency—especially given the history of DHHS with ME/CFS— and provide a reply of your findings. As you may be aware, DHHS was investigated by the Office of the Inspector General as well as the Government Accountability Office in the 1990s and it was determined that the CDC misappropriated millions of congressionally mandated taxpayer money allocated to the research of ME/CFS. This prior malfeasance of DHHS with respect to ME/CFS mandates special attention to the current matter. Given this alarming history, it is imperative that my request for investigation be treated with the utmost urgency and seriousness. The IOM has begun with the ME/CFS study process and taxpayer money is spent on this potentially tainted federal contract every day. If you find violations of federal law in entering into the IOM Contract, as I believe you will, it is imperative that any further waste of taxpayer money is stopped immediately.
I would be pleased to respond to any questions you might have in this regard.
Attorney at Law
CFSAC Listserv Message, September 3, 2013
Barack Obama, President of the United States of America
Daniel R. Levinson, Inspector General, Office of Inspector General, U.S. Department of Health and Human Services
Adam Trzeciak, Inspector General, U.S. Government Accountability Office
Senator Harry Reid, Majority Leader in the U.S. Senate
Senator Tom Harkin, Chairman, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Senator Jerry Moran, Ranking Member, Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Jack Kingston, Chairman, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Rosa DeLauro, Ranking Member, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Lucille Roybal-Allard, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Barbara Lee, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Mike Honda, California, U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
Secretary of Health and Human Services Kathleen Sebelius
 41 U.S.C. § 403(6).
 10 U.S.C. § 2304(c) and 41 U.S.C. § 253(c).
 10 U.S.C. § 2304(c) and 41 U.S.C. § 253(c).
 CFSAC Recommendations, October 3-4, 2012 meeting: http://www.hhs.gov/advcomcfs/recommendations/10032012.html
 41 U.S.C. § 403(7).
 10 U.S.C. § 2304(f)(5)(A) and 41 U.S.C. § 253(f)(5)(A).
 48 C.F.R. §6.305(a)(1)
 48 C.F.R. §6.305(a)(2)
 14 U.S.C. § 416(a)(3).
 48 C.F.R. §6.304(a)(2).