Health

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 a subcommittee legislative hearing to discuss the reauthorization of Food and Drug Administration animal drug and animal generic drug use free programs.  “From pet owners, to farmers and poultry producers, Americans rely on pharmaceuticals and generic drugs to keep our animals healthy and happy. It’s crucial that we continue to modernize the FDA’s Center for Veterinary Medicine review process, so sponsors can continue to review bring safe and effective animal drugs to the market. We look forward to the work ahead on reauthorizing these critical user fee programs—as we’ve done in the past—before their September 30 expiration date.”  Subcommittee on Health hearing titled “Reauthorization of the Animal Drug User Fee Programs.” WHAT : A legislative hearing to discuss reauthorization of the FDA’s animal drug and animal generic drug user fee programs.  DATE : Thursday, March 30, 2023  TIME : 9:00 AM ET  LOCATION : 2123 Rayburn House Office Building  WITNESSES : Witnesses will be announced and are by invitation only.  LEGISLATION UNDER CONSIDERATION : H.R. 1418, the Animal Drug User Fee Amendments of 2023, and H.R. 1683, the Generic Animal Drug Advancement Act.  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), House Ways and Means Committee Chair Jason Smith (R-MO), Energy and Commerce Subcommittee on Health Chair Brett Guthrie (R-KY), and Ways and Means Subcommittee on Health Chair Vern Buchanan (R-FL), along with their Republican committee colleagues, wrote to Department of Health and Human Services Secretary Xaiver Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure, urging them to provide clarity to seniors regarding the CMS Calendar Year 2024 Advance Notice for the Medicare Advantage (MA) program.  Energy and Commerce Committee Chair Rodgers: “Before making any significant unilateral changes to Medicare, the Biden administration needs to have an unambiguous understanding of any potential effect on seniors’ benefits and premiums. That said, excess payments that were not authorized or intended by Congress are a misuse of taxpayer dollars that weaken the Medicare program. Congress should seek to address both problems broadly across Medicare and the federal budget. If the administration has done its due diligence, it should have no issues responding promptly to our reasonable questions."  Ways and Means Committee Chair Smith: “President Biden’s has a detailed track record of mismanaging Medicare for our nation's seniors, from implementing the largest ever increase in Medicare premiums to severely limiting access to novel treatments such as for Alzheimer's. It is vital that the Biden Administration clarify the changes they are forcing through and the rationale behind them. The 31 million seniors who rely on Medicare Advantage need assurance that their cost, coverage, and access to care will not be impacted.”   Energy and Commerce Health Subcommittee Chair Brett Guthrie: “This is about ensuring the more than 31 million seniors, who use Medicare Advantage, and Congress understand the real impact the Biden Administration’s proposed changes will have on the availability of MA services across the country. The Biden Administration’s history with Medicare gives reason for skepticism and a call for more transparency on the decision-making behind the Biden Administration’s proposed changes.”   Ways and Means Health Subcommittee Chair Buchanan: “Medicare Advantage is an enormously successful program and model of a public-private partnership that offers greater choice, increased competition and lower costs,” said Buchanan. “The Biden administration’s proposed changes to Medicare are a direct attack on the 55 percent of Florida seniors enrolled in Medicare Advantage, and could affect their ability to receive access to timely, quality health care. At a time when inflation is eating away at seniors’ budgets, many of whom live on fixed incomes, the last thing they need are higher out-of-pocket costs and major cuts in services.”  The members requested responses to their questions no later than March 24, 2023.  CLICK HERE to read the full letter. 

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 Committee Chair Cathy McMorris Rodgers (R-WA), House Ways and Means Committee Chair Jason Smith (R-MO), Energy and Commerce Subcommittee on Health Chair Brett Guthrie (R-KY), and Ways and Means Subcommittee on Health Chair Vern Buchanan (R-FL), along with their Republican committee colleagues, wrote to Department of Health and Human Services Secretary Xaiver Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure, urging them to provide clarity to seniors regarding the CMS Calendar Year 2024 Advance Notice for the Medicare Advantage (MA) program.  Energy and Commerce Committee Chair Rodgers: “Before making any significant unilateral changes to Medicare, the Biden administration needs to have an unambiguous understanding of any potential effect on seniors’ benefits and premiums. That said, excess payments that were not authorized or intended by Congress are a misuse of taxpayer dollars that weaken the Medicare program. Congress should seek to address both problems broadly across Medicare and the federal budget. If the administration has done its due diligence, it should have no issues responding promptly to our reasonable questions."  Ways and Means Committee Chair Smith: “President Biden’s has a detailed track record of mismanaging Medicare for our nation's seniors, from implementing the largest ever increase in Medicare premiums to severely limiting access to novel treatments such as for Alzheimer's. It is vital that the Biden Administration clarify the changes they are forcing through and the rationale behind them. The 31 million seniors who rely on Medicare Advantage need assurance that their cost, coverage, and access to care will not be impacted.”   Energy and Commerce Health Subcommittee Chair Brett Guthrie: “This is about ensuring the more than 31 million seniors, who use Medicare Advantage, and Congress understand the real impact the Biden Administration’s proposed changes will have on the availability of MA services across the country. The Biden Administration’s history with Medicare gives reason for skepticism and a call for more transparency on the decision-making behind the Biden Administration’s proposed changes.”   Ways and Means Health Subcommittee Chair Buchanan: “Medicare Advantage is an enormously successful program and model of a public-private partnership that offers greater choice, increased competition and lower costs,” said Buchanan. “The Biden administration’s proposed changes to Medicare are a direct attack on the 55 percent of Florida seniors enrolled in Medicare Advantage, and could affect their ability to receive access to timely, quality health care. At a time when inflation is eating away at seniors’ budgets, many of whom live on fixed incomes, the last thing they need are higher out-of-pocket costs and major cuts in services.”  The members requested responses to their questions no later than March 24, 2023.  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) 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.