Health

Washington, D.C. — House Committee on Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) and House Committee on Oversight and Accountability Chairman James Comer (R-KY) today wrote to Centers for Medicare & Medicare Services (CMS) Administrator Chiquita Brooks-LaSure, requesting documents and communications to assist in investigating CMS’s response to a data breach impacting personally identifiable information of approximately 254,000 Medicare beneficiaries.  “On October 8, 2022, [Healthcare Management Solutions, LLC (HMS)] ‘was subject to a ransomware attack on its corporate network.’ CMS was notified about the data breach a day later, and on October 18, 2022, CMS ‘determined with high confidence that the incident potentially included personally identifiable information and protected health information for some Medicare enrollees.’ However, it was not until December 1, 2022, that CMS made the determination that the data breach constituted a ‘major incident,’ as defined in the Federal Information Security Modernization Act of 2014,” wrote Rodgers and Comer.   After becoming aware of a major data breach and potential exposure of Medicare beneficiaries’ personal information, it took CMS two months to determine that the data breach constituted a “major incident” as defined in the Federal Information Security Modernization Act.  “In other words, bad actors had access to Medicare beneficiaries’ information for two months before CMS determined this ransomware attack was a ‘major incident,’ triggering a legal obligation to inform Congress of such incident. [...] The compromised information potentially includes the following personally identifiable information (PII) and protected health information (PHI): name, address, date of birth, phone number, Social Security Number, Medicare beneficiary identifier, banking information, including routing and account numbers, and Medicare entitlement, enrollment, and premium information,”  continued Chairs Rodgers and Comer.   CLICK HERE to read the letter to Administrator Brooks-LaSure. 

Washington, D.C. — House Energy and Commerce Subcommittee on Health Chair Brett Guthrie (R-KY) published an opinion piece in the Washington Examination ahead of a March 28th hearing where Members will explore how transparency and competition can lower health care costs for Americans.  Key Excerpts Below from the Washington Examiner piece titled “ Empowering patients through price transparency ”: “Our country’s most formidable healthcare challenges are rooted in ever-rising healthcare costs and a lack of basic transparency. Despite our country spending more than $4 trillion a year on healthcare, or about $13,000 per person, patients are not able to make informed decisions about how and where to spend their money as they can in virtually every other industry.”  […]  “Thankfully, there are bipartisan solutions to make healthcare pricing more transparent and the healthcare system easier to navigate for patients. These include the Centers for Medicare and Medicaid Services hospital price transparency rule and the multidepartment transparency in coverage rule, which were initially issued under then-President Donald Trump and continued by the Biden administration. These rules require hospitals to post publicly the prices of hundreds of common procedures on their website in a user-friendly format and require private health plans to disclose information about pricing and what patients are obligated to pay.”  […]  “Price transparency can also provide insight on why the costs of care are rapidly increasing. Exposing prices would help show whether healthcare services are priced correctly and give policymakers a clearer look at the value, or lack thereof, of some of the many steps in the healthcare supply chain.  “At the end of March, the Health Subcommittee will hold a hearing on healthcare affordability to examine these price transparency rules and other policies that promote more choices and drive down the costs of care for patients.  “Congress should also consider solutions to ensure the public and its employers are getting the best possible deal on their prescription drug benefits. We should build on our bipartisan   work to save our healthcare system billions of dollars and make pharmacy benefit managers be more transparent. Shining a light on these middlemen who are making prescriptions more expensive is one important step to bolster competition and allow for affordable new drugs, such as generics and biosimilars, to be made available for patients.”  CLICK HERE to read the full piece. 

Biden’s Partisan and Unrealistic Budget Request is Wrong for Americans Washington, D.C. —  House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee on Health Chair Brett Guthrie (R-KY) today announced that U.S. Department of Health and Human Services Secretary Xavier Becerra will testify at a hearing to discuss President Biden’s Fiscal Year 2024 (FY24) Budget Request.  “President Biden’s reckless spending is forcing Americans to deal with record levels of inflation. It has made it more difficult to purchase healthy foods, caused greater stresses on families, and driven up health care costs across the board. His budget request doubles down on massive inflationary spending, would crush medical innovation for new cures, attacks states’ rights to manage their Medicaid needs, forces taxpayers to fund abortion, and fails to restore trust in our public health agencies. Secretary Becerra owes it to the American people to explain why the Biden administration is placing these priorities over lowering health care costs, combating the fentanyl crisis, and protecting the dignity of all human life.”  WHAT : A hearing to discuss President Biden’s FY24 Budget Request  DATE : Wednesday, March 29, 2023    TIME : 10:00 AM ET   LOCATION : 2123 Rayburn House Office Building    This notice is at the direction of the Chair. The hearing will be open to the public and press and will be live streamed online at  https://energycommerce.house.gov/ . If you have any questions concerning the hearing, please contact Jolie Brochin with the Committee staff at  Jolie.Brochin@mail.house.gov . If you have any press-related questions, please contact Christopher Krepich at  Christopher.Krepich@mail.house.gov . 

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) sent a letter today to Dr. Lawrence Tabak, the senior official who is performing the duties of Director of the National Institutes of Health (NIH). This inquiry follows up an August 2022 letter to NIH regarding its handling of sexual harassment complaints.  KEY EXCERPT:   “ NIH’s own statistics show a significant problem with more than 300 cases related to harassment since 2018. That also represents hundreds of women who are being bullied or threatened.”  […]  “All the more troubling is the fact that recent independent surveys have found top institutions and major NIH grant recipients with a high number of reported instances of sexual misconduct. In 2015, the Association of American Universities (AAU) conducted a campus survey on Sexual Assault and Sexual Misconduct. This survey included over 150,000 undergraduate, graduate, and professional students at 27 universities that participated. For example, Yale University had the highest rates of female sexual assault with the exception of two other universities, which both boast a significantly larger student body population. Further, in 2019, AAU conducted a follow up Campus Sexual Assault and Sexual Misconduct survey and found that sexual assaults at Yale had actually increased.  “ Such findings and high-profile cases raise concerns about possible non-compliance with Federal laws applicable to NIH funding, including Title IX. As you know, Yale has been among the largest recipients of Federal taxpayer funding in the form of research grants. During the past ten years, for example, Yale has received approximately 9,584 awards to faculty and professors totaling around $4.3 billion from NIH alone. Each of these grants were conditioned on Yale’s full compliance with applicable Federal laws such as Title IX. We could cite several other major grantee institutions for similar issues.   “Based on the massive number of NIH grants and billions of Federal funds benefitting or inuring to the benefit of Yale and ongoing inquiries, we are concerned that Yale and other institutions may not have complied with their responsibilities under Title IX as a recipient of Federal funds. Compliance with Title IX is more than a mere formality—it is a prerequisite for receipt of Federal funds. Additionally, the Department of Health and Human Services (HHS) asserts that complying with research grant requirements is a significant priority.”  The Chairs asked for the information, including responses to the following questions, by March 28, 2023:  Upon receipt of a harassment complaint, what is the NIH process for requesting more information from grantees?  Does the NIH ask different questions if special populations (children) are involved in the complaint?  Does the NIH ever talk to the alleged victim of harassment, not just the grantee institution?  How many complaints were sent directly to the NIH Director or Acting NIH Director since January 1, 2019? How many of these complaints were referred to the OER? If there were any complaints not referred to OER, why not?  NIH indicated it was working with HHS Office of Civil Rights in September 2020. What was the outcome of these interactions? How many targets of discrimination or retaliation have been contacted as a result? Were NIH investigations or institutional Title IX investigations (or others) reviewed? Please provide specifics.  CLICK HERE to read the full letter. 

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) today, in a letter to Dr. Lawrence Tabak, the senior official who is performing the duties of Director of the National Institutes of Health (NIH) requested information from the NIH regarding grants that have been misallocated or grants with low or de minimis value that have the potential to harm the Institutes’ reputation.  KEY EXCERPT:   “We are interested in learning more about how, and to what extent, institutes and centers are implementing audit recommendations related to misallocated funds.”  […]  “In addition, the NIH apparently has a significant number of grants of low or de minimis value ($1,000 or less) that have been awarded. Based on a Majority Committee staff search of the NIH Reporter system, there are 292 grants in this low dollar category ($1,000 or less).”  […]  “ These low dollar awards have the effect of establishing a relationship between an entity and NIH but with no apparent research value associated with the award itself. It is our understanding from reviewing the terms of NIH grant documents that, unless the funds are drawn, the NIH protections, reporting requirements, and activity limitations do not apply to the grantee. So, the recipient appears to gain the benefit from its association with the NIH without the burden of the requirements. This may pose a risk to NIH, both in reputation and compliance. ”  The Chairs specifically asked for responses to the following questions by March 27, 2023: Since January 1, 2015, how many audits have been conducted by the NIH Office of Management Assessment (OMA)?  Since January 1, 2015, how many audits have been conducted by OMA and identified as a misallocation of funds in an award?  Since January 1, 2015, how many referrals of audit findings have been made by OMA to institutes and centers? Please specify the number and nature of the audit findings for each institute and center.  What are the potential actions that an institute or center can take on an audit finding?  What was the total amount of funds that OMA found in which NIH was entitled to recovery?  Out of that total amount of funds that OMA found in which NIH was entitled to recovery, what was the total amount of funds actually recovered?  How frequently are awards audited, and how is the frequency determined?  How many recommendations did OMA make to the institutes and centers, and how many recommendations were implemented?  Please produce the results of searching for NIH grants $1,000 or less in the eRA Commons system.  Has OMA conducted its own search of low value NIH grants? If so, when and why? What were the results?  How many low dollar grants are currently active? What is the purpose of low dollar grants?  Are all the U.S. entities listed as low dollar grant recipients owned and controlled by U.S. persons?  Why are there low dollar grants? Is it an end around some law, regulation, or Congressional requirement? Is it some administrative mechanism created to enable some activity?  What benefit to NIH is there from low dollar grants? Are there any trends to suggest a lack of impartiality on the part of awards? Is this process being exploited and by whom (perhaps nation states)?  What is the risk to NIH in such affiliations if in fact awardees are not beholden to the grants policy statement unless they draw the funds?  Please identify the sub-awardees and explain why there is a sub-awardee on such a small award.  CLICK HERE to read the full letter. 

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) today, in a letter to Dr. Lawrence Tabak, the senior official who is performing the duties of Director of the National Institutes of Health (NIH), requested information about the NIH’s failure to convene the Scientific Management Review Board (SMRB) as required under the NIH Reform Act of 2006. The Board advises the NIH on the most effective organizational structure for NIH.  KEY EXCERPT:   “According to a STAT review of agency records, the SMRB, tasked with making the NIH more efficient and more effective, 'mysteriously stopped meeting seven years ago' and SMRB members do not know why. As noted by STAT, 'the de facto disappearance of the NIH’s Scientific Management Review Board, critics charge, is emblematic of the agency’s broader reluctance to accept criticism and to modernize. Some science policy experts have argued lately that the NIH operates too slowly, funds research too conservatively, and labors under a bureaucratic structure that is cumbersome and unwieldy.' Further, by not convening the SMRB, the NIH is missing opportunities to address profound scientific management concerns such as what actions NIH is taking, or needs to take, to increase support for young researchers in the NIH intramural program.  “ By not convening the SMRB for the last seven years, the NIH has failed to comply with the NIH Reform Act of 2006. This law created the SMRB to provide advice on the use of organizational authorities granted to the NIH, and formally and publicly to review NIH’s organizational structure at least once every seven years. The law set out time frames for the Director to act on such recommendations and provide for review by Congress. As required by the Reform Act, SMRB has conducted public reviews of NIH’s organizational structure and processes from 2010 to 2015 but has not been convened since 2015.  “We note from the Board’s chart posted on the NIH website, that the estimated annual cost for operating the Board, including compensation and travel expenses for members, but excluding staff support, is $167,851. The estimate of annual person-years of staff support required is 2.2 full-time equivalent employees (FTEs), at an approximate annual cost of $321,050. The total annual cost of the Board is $488,901. Without convening the SMRB as was done from 2010 to 2015, we are concerned that the NIH has diverted this funding reserved for operating and supporting the SMRB to other purposes.”   The Chairs specifically requested the following information by March 27, 2023: Please explain why the NIH has failed to convene the SMRB since 2015. Who decided to stop convening the SMRB? When was this decision made? If the decision is in writing, please provide. If the decision is not in writing, why not?  Since the NIH has discontinued convening this board since 2015, how has the NIH used the $488,901 per year or $2,933,406 over six years?    Will the NIH return to the U.S. Treasury the more than $2.9 million in funding that was not used for operating and supporting the SMRB?   Please name the NIH staff who were originally designated to be responsible for staff support of the SMRB. What have these designated staff been working on since 2015 instead of supporting the SMRB?  Will the NIH reconvene the SMRB, and if so, when?  Can you provide a list of all recommendations voted on by the SMRB and the votes with respect to each recommendation?  For those recommendations that were supported by the SMRB, please provide the status of implementation of those recommendations.  CLICK HERE to read the full letter.