Health

Report Requested by E&C Republicans to Better Understand Obamacare Program Integrity Washington, D.C. — A new report issued by the Government Accountability Office (GAO) has found that the Centers for Medicare and Medicaid Services (CMS) does not adequately enforce Obamacare’s requirement that states fund the cost of state-mandated health insurance benefits. The report, requested by Energy and Commerce Committee Republicans, raises issues about CMS’s controls to ensure federal taxpayer dollars are not illegally subsidizing state mandates. BACKGROUND : Obamacare mandates a certain set of essential health benefits (EHBs) be covered by insurance plans within the individual health insurance market. States may choose to mandate additional benefits but are then required to cover the cost of such benefits. States are not permitted to use federal tax dollars, in the form of Advance Premium Tax Credits (APTCs), to do so. In its report, GAO found that CMS delegates oversight of this policy to the States instead of enforcing it on its own. As outlined in the report, “CMS has limited assurance that APTCs accurately exclude the costs of non-EHB mandated benefits” and that “CMS has expressed concerns about states’ compliance with this requirement,” highlighting critical concerns about the potential for improper federal spending. “This report, coupled with the immense Obamacare fraud this administration has overseen, highlights the need for Congress and the incoming administration to work swiftly to safeguard taxpayer funds at every corner of the agency. CMS should prioritize rigorous enforcement of all requirements intended to prevent improper spending,” said Committee Chair Cathy McMorris Rodgers (R-WA). “I commend GAO for its investigative efforts, which will help Congress protect taxpayer dollars by correcting government waste, fraud, and abuse.” REPORT HIGHLIGHTS : CMS is supposed to enforce this requirement on States, but defers to states to enforce this federal requirement on themselves:  “States may require marketplace plans to cover items and services in addition to EHB; we refer to such benefits as non-EHB mandated benefits. However, APTCs cannot be used to offset the costs of these additional benefits. Specifically, the Centers for Medicare & Medicaid Services (CMS)—the federal agency responsible for determining the APTC amounts—must exclude the costs of non-EHB mandated benefits from the APTC calculation. CMS delegates responsibility for identifying non-EHB mandated benefits to the states.”   Even CMS has concerns with State compliance with the Obamacare requirement that States fund the cost of their coverage mandates.  “However, CMS has expressed concerns about states’ compliance with this requirement. For example, in the 2021 Payment Notice, CMS noted state confusion regarding the identification of non-EHB mandated benefits and concerns that the premium data it uses to calculate the APTCs did not exclude their costs, resulting in improper federal payments. CMS reiterated these concerns in its 2022 and 2023 Payment Notices.”   GAO found one state that did not believe it had the responsibility to identify benefits that it must fund, contrary to CMS’s position of deference to states.  “Further, we identified one state that inappropriately placed the onus on CMS to determine whether a mandated benefit was non-EHB, rather than identify these benefits itself.”   CMS does not know if premium data appropriately excludes state-mandated benefits:  “In addition, CMS does not know whether the premium data submitted by marketplace plans and used to calculate APTCs exclude the costs of non-EHB mandated benefits.”   GAO concludes that CMS does not have assurances that federal taxpayer dollars are not improperly funding state-mandated benefits.  “CMS has limited assurance that APTCs accurately exclude the costs of non-EHB mandated benefits. This poses a risk to its oversight objective and is inconsistent with federal internal control standards. These standards state that agencies should identify, analyze, and respond to risks related to achieving agency objectives. Assessing whether its current oversight approach is sufficient to respond to identified risks and making changes as appropriate would be consistent with these standards. Such an assessment would also provide greater assurance that the APTCs accurately exclude the costs of non-EHB mandated benefits.”   CLICK HERE to read the GAO report.

House Republicans scrutinize government grant funding recipients that fail to protect individuals from antisemitism Washington, D.C. — In a new letter to J. David Gladstone Institutes President Dr. Deepak Srivastava, the House Committee on Energy and Commerce (E&C) and House Committee on Education and the Workforce (E&W) have requested information about ongoing and pervasive acts of antisemitic harassment and intimidation at Gladstone and its leadership’s insufficient response to these acts. The letter is signed by E&C Chair Cathy McMorris Rodgers (R-WA), E&C Subcommittee on Health Chair Brett Guthrie (R-KY), E&C Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), E&W Chair Virginia Foxx (R-NC), and E&W Subcommittee on Higher Education and Workforce Development Chair Burgess Owens (R-UT).  KEY LETTER EXCERPTS: “The Gladstone Institutes, an independent biomedical research organization, claims that it takes an active stance against serious issues like discrimination and harassment and aims to ‘ensure all community members at Gladstone feel included’ and that the Institutes will aim to ‘implement accountability measures and reinforce Gladstone’s commitment to having an environment free of harassment.’ However, these values do not seem to be reflected in the actions of leadership in response to recent concerns of antisemitic harassment and discrimination within the Institutes.” [...] “The reports of antisemitic harassment at Gladstone coupled with the inadequate response by leadership is concerning to the Committees. Failing to act decisively to ensure a safe environment for all trainees, faculty, and staff is a grave dereliction of your responsibilities as President of Gladstone.” “Failing to comply with basic safety protections for members of Gladstone or failure to respond appropriately to and prevent harassment and discrimination, no matter the cause, may be grounds to withhold federal funds from the university. Congress has an obligation to exercise oversight of recipients of federal funds when blatant and ongoing Title VI violations appear to be happening. If Congress determines an institution of higher education/research is blatantly ignoring its legal responsibilities, we may consider rescinding research and development funds previously appropriated.” BACKGROUND ON TAXPAYER FUNDING: Gladstone received more than $41 million in funding from the NIH in Fiscal Year 2023, not including potential taxpayer funding that individual faculty may have received through their affiliation with the University of California, San Francisco (UCSF) or any other affiliated universities.   According to the NIH’s Grant Policy Statement, any institution receiving federal funds must assure work environments are free of discriminatory harassment and are safe and conducive to high-quality work.  Institutions receiving federal taxpayer financial assistance—such as NIH grants—are prohibited from discriminating based on a variety of categories, including national origin.   These laws also protect members of the institution who are or are perceived to be members of a group with shared ancestry, such as students/trainees of Jewish heritage. BACKGROUND ON INSTANCES OF ANTISEMITISM : Two days after the October 7, 2023, Hamas terrorist attack, a graduate student working in a lab within Gladstone sent an antisemitic email to all Gladstone faculty, trainees, and staff falsely stating that the attack on innocent Israeli civilians was “the resistance in Gaza launch[ing] a surprise attack against Israel, taking occupation soldiers hostage, taking over Israeli military vehicles, and gain[ing] control over illegal Israeli settlements.”  The email goes on to claim that all casualties resulting from Palestinian actions are the responsibility of Israel.  Immediately following this mass email, members of the Gladstone faculty began contacting the Gladstone Institutes’ President and other leadership, appalled by the language of the email, concerned for their safety and worried that the email could be seen as an incitement to violence.  Jewish members of the Institutes also expressed their deep, personal pain following the Hamas attack, as some members had family or friends reported killed or missing directly after the attack.  These fears—including fears of being attacked in the lab by the author of this cruel and antagonistic email—were shared directly with President Srivastava.  Despite this, Gladstone leadership did not issue a public statement or position against antisemitism to quell fears of Jewish faculty and trainees.  In May 2024, the Center for Combatting Antisemitism sent President Srivastava a letter requesting administrative action to address the hostile environment and disparate treatment of Jewish members at Gladstone.  This letter noted that Gladstone refused to acknowledge Jewish American Heritage Month, Passover, or Holocaust Remembrance Day, despite sending official celebratory emails and holding events for other religious, ethnic, or national holidays, including Black History Month, International Women’s Day, and Ramadan.  The Center followed up with Gladstone several times, but never received a response.  Jewish faculty and trainees have conveyed to leadership within Gladstone instances of antisemitic harassment and discrimination, which faculty and trainees believe were not taken seriously, making some feel uneasy about speaking out.  For example, per a publicly available Fair Employment and Housing Act complaint to the California Civil Rights Division, a Jewish faculty member openly discussed fellow faculty using racial stereotypes, including comments about a “Jewish nose.”  When these comments were brought to human resources, no investigation occurred.  Instead, the complainant was subsequently targeted with an investigation ultimately deemed to be unwarranted.  Then, following the complainant’s post-October 7th advocacy on behalf of Jewish faculty and trainees, the complainant was threatened repeatedly with career-ending termination, allegedly in an attempt to extort a resignation.  When the threats did not have their desired effect, Gladstone placed the complainant on administrative leave and removed the complainant’s electronic access to email and files but also physical access to the complainant’s lab, removing all ability to conduct work on an NIH-funded grant.  Gladstone ultimately paid an undisclosed sum to settle the matter and avoid litigation.  To elevate concerns regarding widespread, ongoing discrimination, Jewish faculty and trainees requested permission to bring in a speaker related to antisemitism.  Other minority groups had previously been given permission to bring in similar anti-racism speakers.  However, while leadership stated it would look into the idea, ultimately no speaker was brought, and no program was launched regarding antisemitism. BACKGROUND ON AFFILIATIONS WITH OTHER INSTITUTIONS UNDER INVESTIGATION : Gladstone Institutes is affiliated with other institutions under congressional investigation.  For example, Gladstone is an affiliate of the UCSF, which is undergoing congressional investigation for reports of antisemitism within the university, medical school, and medical centers.  Most of Gladstone’s principal investigators are also faculty at UCSF, and the Institutes provide research positions and opportunities for graduate students from UCSF.  Moreover, there is a joint institute—the Gladstone-UCSF Institute of Genomic Immunology—further linking the two institutions.  Gladstone is also affiliated with the University of California, Berkeley and Stanford University, both of which are also under investigation for concerns related to antisemitism. CLICK HERE to read the full letter.

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) issued the following statement after President Biden signed H.R. 7189, the Congenital Heart Futures Reauthorization Act , into law. The bill, led by Rep. Gus Bilirakis (R-FL), passed unanimously in the House on September 23, 2024, and the Senate on September 25, 2024. “More than 40,000 babies in the United States are born with a heart defect each year, making this news a positive step toward saving lives and improving the health and wellbeing of those affected by congenital heart conditions. I commend Rep. Bilirakis for his leadership on this bipartisan law that will support research and education on congenital heart disease throughout every stage of life,” said Chair Rodgers .  "As a co-founder of the Congenital Heart Caucus, I’ve become familiar with the struggles patients with congenital heart disease and their families face. This new law brings us one step closer to enhancing better treatment options and improving outcomes for all patients suffering with this condition. We’ve seen that this program yields positive results and I look forward to it continuing to help future generations live longer, healthier lives," said Rep. Bilirakis . H.R. 7189 reauthorizes and makes improvements to the national congenital heart disease research, surveillance, and awareness program at the CDC through fiscal year 2029. It passed out of the House Energy and Commerce Committee unanimously on March 20, 2024.

House Republicans scrutinize government grant funding recipients that fail to protect individuals from antisemitism Washington, D.C. — In a new letter to J. David Gladstone Institutes President Dr. Deepak Srivastava, the House Committee on Energy and Commerce (E&C) and House Committee on Education and the Workforce (E&W) have requested information about ongoing and pervasive acts of antisemitic harassment and intimidation at Gladstone and its leadership’s insufficient response to these acts. The letter is signed by E&C Chair Cathy McMorris Rodgers (R-WA), E&C Subcommittee on Health Chair Brett Guthrie (R-KY), E&C Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), E&W Chair Virginia Foxx (R-NC), and E&W Subcommittee on Higher Education and Workforce Development Chair Burgess Owens (R-UT).  KEY LETTER EXCERPTS: “The Gladstone Institutes, an independent biomedical research organization, claims that it takes an active stance against serious issues like discrimination and harassment and aims to ‘ensure all community members at Gladstone feel included’ and that the Institutes will aim to ‘implement accountability measures and reinforce Gladstone’s commitment to having an environment free of harassment.’ However, these values do not seem to be reflected in the actions of leadership in response to recent concerns of antisemitic harassment and discrimination within the Institutes.” [...] “The reports of antisemitic harassment at Gladstone coupled with the inadequate response by leadership is concerning to the Committees. Failing to act decisively to ensure a safe environment for all trainees, faculty, and staff is a grave dereliction of your responsibilities as President of Gladstone.” “Failing to comply with basic safety protections for members of Gladstone or failure to respond appropriately to and prevent harassment and discrimination, no matter the cause, may be grounds to withhold federal funds from the university. Congress has an obligation to exercise oversight of recipients of federal funds when blatant and ongoing Title VI violations appear to be happening. If Congress determines an institution of higher education/research is blatantly ignoring its legal responsibilities, we may consider rescinding research and development funds previously appropriated.” BACKGROUND ON TAXPAYER FUNDING: Gladstone received more than $41 million in funding from the NIH in Fiscal Year 2023, not including potential taxpayer funding that individual faculty may have received through their affiliation with the University of California, San Francisco (UCSF) or any other affiliated universities.   According to the NIH’s Grant Policy Statement, any institution receiving federal funds must assure work environments are free of discriminatory harassment and are safe and conducive to high-quality work.  Institutions receiving federal taxpayer financial assistance—such as NIH grants—are prohibited from discriminating based on a variety of categories, including national origin.   These laws also protect members of the institution who are or are perceived to be members of a group with shared ancestry, such as students/trainees of Jewish heritage. BACKGROUND ON INSTANCES OF ANTISEMITISM : Two days after the October 7, 2023, Hamas terrorist attack, a graduate student working in a lab within Gladstone sent an antisemitic email to all Gladstone faculty, trainees, and staff falsely stating that the attack on innocent Israeli civilians was “the resistance in Gaza launch[ing] a surprise attack against Israel, taking occupation soldiers hostage, taking over Israeli military vehicles, and gain[ing] control over illegal Israeli settlements.”  The email goes on to claim that all casualties resulting from Palestinian actions are the responsibility of Israel.  Immediately following this mass email, members of the Gladstone faculty began contacting the Gladstone Institutes’ President and other leadership, appalled by the language of the email, concerned for their safety and worried that the email could be seen as an incitement to violence.  Jewish members of the Institutes also expressed their deep, personal pain following the Hamas attack, as some members had family or friends reported killed or missing directly after the attack.  These fears—including fears of being attacked in the lab by the author of this cruel and antagonistic email—were shared directly with President Srivastava.  Despite this, Gladstone leadership did not issue a public statement or position against antisemitism to quell fears of Jewish faculty and trainees.  In May 2024, the Center for Combatting Antisemitism sent President Srivastava a letter requesting administrative action to address the hostile environment and disparate treatment of Jewish members at Gladstone.  This letter noted that Gladstone refused to acknowledge Jewish American Heritage Month, Passover, or Holocaust Remembrance Day, despite sending official celebratory emails and holding events for other religious, ethnic, or national holidays, including Black History Month, International Women’s Day, and Ramadan.  The Center followed up with Gladstone several times, but never received a response.  Jewish faculty and trainees have conveyed to leadership within Gladstone instances of antisemitic harassment and discrimination, which faculty and trainees believe were not taken seriously, making some feel uneasy about speaking out.  For example, per a publicly available Fair Employment and Housing Act complaint to the California Civil Rights Division, a Jewish faculty member openly discussed fellow faculty using racial stereotypes, including comments about a “Jewish nose.”  When these comments were brought to human resources, no investigation occurred.  Instead, the complainant was subsequently targeted with an investigation ultimately deemed to be unwarranted.  Then, following the complainant’s post-October 7th advocacy on behalf of Jewish faculty and trainees, the complainant was threatened repeatedly with career-ending termination, allegedly in an attempt to extort a resignation.  When the threats did not have their desired effect, Gladstone placed the complainant on administrative leave and removed the complainant’s electronic access to email and files but also physical access to the complainant’s lab, removing all ability to conduct work on an NIH-funded grant.  Gladstone ultimately paid an undisclosed sum to settle the matter and avoid litigation.  To elevate concerns regarding widespread, ongoing discrimination, Jewish faculty and trainees requested permission to bring in a speaker related to antisemitism.  Other minority groups had previously been given permission to bring in similar anti-racism speakers.  However, while leadership stated it would look into the idea, ultimately no speaker was brought, and no program was launched regarding antisemitism. BACKGROUND ON AFFILIATIONS WITH OTHER INSTITUTIONS UNDER INVESTIGATION : Gladstone Institutes is affiliated with other institutions under congressional investigation.  For example, Gladstone is an affiliate of the UCSF, which is undergoing congressional investigation for reports of antisemitism within the university, medical school, and medical centers.  Most of Gladstone’s principal investigators are also faculty at UCSF, and the Institutes provide research positions and opportunities for graduate students from UCSF.  Moreover, there is a joint institute—the Gladstone-UCSF Institute of Genomic Immunology—further linking the two institutions.  Gladstone is also affiliated with the University of California, Berkeley and Stanford University, both of which are also under investigation for concerns related to antisemitism. CLICK HERE to read the full letter.

Washington, D.C. — In a new letter to Government Accountability Office Comptroller General Gene Dodaro, House Energy and Commerce Committee Republicans have requested an examination of the structure of laboratory safety programs at the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH).  The letter was signed by 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).  KEY LETTER EXCERPT :  This committee remains concerned about the effectiveness of the oversight HHS and its agencies provide to the laboratories they own and operate. In addition to numerous GAO recommendations that remain unimplemented by the FDA, both the CDC and the FDA recently announced organizational reforms to their laboratory safety and security functions, and it is not clear whether these changes will strengthen oversight or create new undue risk. The FDA has, for example, reorganized several of its laboratories such that they now fall within the Office of the Chief Scientist. This raises potential independence concerns, as the FDA’s laboratory safety and security functions report to the same office.  BACKGROUND :  The mission of the U.S. Department of Health and Human Services (HHS) is to enhance the health and well-being of all Americans.   As such, HHS is most directly involved in leading public health preparedness and response efforts, as well as associated research.   However, past safety lapses involving the CDC, the FDA, and the NIH have been the result of multiple breakdowns in compliance with established policies coupled with inadequate oversight.   For example, in July 2014, boxes containing decades-old vials of smallpox and other hazardous biological agents were found in a storage space of an FDA laboratory on the NIH’s campus. GAO and other reviews resulted in numerous findings and recommendations to strengthen laboratory safety and security, which led to changes to the way HHS and its agencies oversee their laboratories.   Likewise, GAO and other reviews have highlighted the importance of laboratory science and security in the handling of federal select agents and other dangerous pathogens in research.  CLICK HERE to read the full letter.

Washington, D.C. — In a letter today to Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., a bipartisan group of House Energy and Commerce Committee Leaders requested a briefing about the presence of counterfeit Ozempic and other semaglutide products in the United States’ medical supply chain.  The letter was signed by Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr. (D-NJ); Subcommittee on Health Chair Brett Guthrie (R-KY) and Ranking Member Anna G. Eshoo (D-CA); and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) and Ranking Member Kathy Castor (D-FL).   KEY LETTER QUOTE : “In addition to concerns about integrity gaps in the legitimate supply chain, we are also concerned about counterfeit Ozempic entering through illegal channels. For example, in June of this year, Eli Lilly issued an open letter expressing concern that counterfeit versions of its own drugs, Mounjaro and Zepbound, were being sold online, through social media and at medical spas. On May 1, 2024, a Department of Justice press release reported that work by FDA’s Office of Criminal Investigations resulted in the arrest of an individual for selling misbranded and adulterated weight loss drugs on TikTok. The Committee fully supports these continued investigations of unlawful sales.”   BACKGROUND :   The FDA alerted the public on December 21, 2023, to the presence of counterfeit Ozempic injection products in the legitimate drug supply; an investigati ve article l ater found that thousands of counterfeit Ozempic pens had arrived in a warehouse in Elmira, New York, as early as the fall of 2023. The fact that counterfeit medications made it into the legitimate medical supply chain raises concern about potential gaps in our supply chain security infrastructure.    This threat continues to grow.   CLICK HERE to read the full letter.