WASHINGTON, D.C. – U.S. Senators Mark R. Warner and Tim Kaine joined Senators Bob Casey (D-PA), John Fetterman (D-PA), Sherrod Brown (D-OH), and Joe Manchin (D-WV) and U.S. Representative Bobby Scott (D-VA-3) in introducing the Black Lung Benefits Improvement Act, which would help miners who have suffered from black lung disease and their survivors access the workers’ compensation they are entitled to receive under the Black Lung Benefits Program. This legislation would remove barriers that prevent miners and their survivors from accessing their benefits such as lengthy processing times, lack of a legal representative, and inflation.
“For generations, coal miners across Virginia have made tremendous sacrifices to power America, literally risking their lives and their health to electrify our nation,” said Senator Warner. “Miners living with black lung and their survivors need easy access to the benefits they’ve earned – but far too often, red tape gets in the way. The Black Lung Benefits Improvement Act would take important steps to make sure miners can access legal representation, have protection against inflation, and more so America can keep making good on the debt it owes to victims of black lung.”
“Many of our nation’s miners have developed black lung disease, and we owe it to them to provide them with the care and support they need,” said Senator Kaine. “The Black Lung Benefits Improvement Act is critical to helping more miners, miner retirees, and their families receive the benefits and compensation they’ve earned following their tremendous sacrifices.”
Many miners have developed coal workers’ pneumoconiosis—commonly referred to as “black lung”—a debilitating and deadly disease caused by the long-term inhalation of coal dust in underground and surface coal mines. In response, Congress passed the Black Lung Benefits Act in 1976 to provide monthly compensation and medical coverage for coal miners who develop black lung disease and are disabled. The Black Lung Benefits Improvement Act makes needed updates to ensure Congress is fulfilling its commitment to the Nation’s coal miners by:
- Restoring cost-of-living benefit increases for black lung beneficiaries and ensuring cost-of-living increases are never withheld in the future,
- Helping miners and their survivors secure legal representation by providing interim attorney fees for miners that prevail at various stages of their claim,
- Allowing miners or their survivors to reopen their cases if they had been wrongly denied benefits because of errors in medical interpretations, and
- Prohibiting unethical conduct by attorneys and doctors in the black lung claims process, such as withholding evidence of black lung, and helping miners review and rebut potentially biased or inaccurate medical evidence developed by coal companies.
Warner and Kaine have long worked to support miners and their families. The Senate-passed draft of the Fiscal Year 2024 government funding bill includes $12.19 million in federal funding for black lung clinics, which the senators are working to ensure is included in the final version of the bill. The Inflation Reduction Act, which the senators helped pass, included a permanent extension of the Black Lung Disability Trust Fund’s excise tax at a higher rate, providing certainty for miners, miner retirees, and their families who rely on the fund to access benefits. This followed Warner and Kaine’s successful efforts to ensure that miners receive the pensions and health care they earned. In July, the senators reintroduced the Relief for Survivors of Miners Act, which would ease restrictions to make it easier for miners’ survivors to successfully claim benefits. Warner and Kaine also urged the Biden Administration to issue new silica standards to protect miners across America – a push that helped contribute towards the release of those standards.
A one-pager on the bill is available here.
Sens. Warner & Kaine Introduce Bipartisan Bill to Expand Access to Telehealth Treatment for Substance Use Disorder
Nov 06 2023
WASHINGTON – U.S. Sens. Mark R. Warner and Tim Kaine (both D-VA) joined Sens. Sheldon Whitehouse (D-RI), Lisa Murkowski (R-AK), and Marsha Blackburn (R-TN) in introducing the Telehealth Response for E-prescribing Addiction Therapy Services (TREATS) Act, legislation that would increase access to telehealth services for individuals with substance use disorder (SUD). During the COVID-19 pandemic, the Drug Enforcement Administration (DEA) temporarily removed an in-person exam requirement for providers to prescribe SUD treatments. This change expanded access to care and reduced the risk of overdose, but it is set to expire at the end of next year. The TREATS Act would make this flexibility permanent.
“Over the course of the COVID-19 pandemic we learned valuable lessons in how to adapt our health care system in order to better care for patients, including the successful treatment of patients with opioid addiction using telehealth services,” said Sen. Warner. “The TREATS Act would make permanent commonsense, safe telehealth practices that will expand care options for those battling with substance use disorder.”
“Telehealth has helped many Virginians get the health care they need, including access to treatments for substance use disorder,” said Sen. Kaine. “By permanently allowing doctors to prescribe life-saving treatments via telehealth, the TREATS Act would better support individuals in recovery and help reduce the risk of overdoses.”
In 2021, 2,622 Virginians died from overdose, averaging seven Virginians per day. Despite strong evidence that medication is the most effective treatment for SUD, only one in five Americans with SUD receive medication treatment that would help them quit and stay in recovery. The TREATS Act would make life-saving medication like buprenorphine more accessible and save lives.
Joining the senators in cosponsoring this legislation are Sens. Catherine Cortez Masto (D-NV), Thom Tillis (R-NC), Shelley Moore Capito (R-WV), Amy Klobuchar (D-MN), Mark Kelly (D-AZ), and Cory Booker (D-NJ). U.S. Representatives David Trone (D-MD-6), Jay Obernolte (R-CA-23), and Brian Fitzpatrick (R-PA-1) led the introduction of the legislation in the House.
Full text of the bill is available here.
Warner, Thune, Cortez Masto, and Young Introduce Bipartisan Legislation to Reduce Burdensome Health Care Reporting Requirements for Employers
Nov 02 2023
WASHINGTON – U.S. Sens. Mark R. Warner (D-VA), John Thune (R-SD), Catherine Cortez Masto (D-NV) and Todd Young (R-IN) today introduced two pieces of bipartisan legislation that would protect Americans’ privacy and remove burdensome and bureaucratic reporting requirements in the Patient Protection and Affordable Care Act (ACA) by allowing certain communications to be electronically filed. Earlier this year, the U.S. House of Representatives unanimously passed companion legislation for the Employer Reporting Improvement Act and the Paperwork Burden Reduction Act.
“The Affordable Care Act was a seismic achievement in expanding access to health care, but it’s still incumbent on Congress to make sure it’s working as smoothly as possible for the Americans and businesses that it serves,” said Sen. Warner. “These two bipartisan bills will take important steps forward to modernize and streamline compliance requirements while protecting privacy, so that more Americans and employers can access and deploy benefits without getting entangled in red tape.”
“Small businesses in South Dakota and across the country have been forced to comply with overly burdensome administrative requirements from the Affordable Care Act,” said Sen. Thune. “These bills would eliminate convoluted paperwork and streamline the current reporting requirements to ensure businesses can focus their resources on serving their customers and employees.”
“We need to make it as easy as possible for Nevada businesses to provide workers with high-quality health care without forcing them to jump through unnecessary hoops,” said Sen. Cortez Masto. “Our bipartisan bills will reduce unnecessary paperwork burdening businesses, and I will continue working to cut through red tape and help Nevadans access high quality health care.”
“Under current law, overreaching compliance requirements create uncertainty and stress for employers in Indiana and across the nation. Our bipartisan bills will help reduce these unnecessary burdens and increase efficiency,” said Sen. Young.
The Employer Reporting Improvement Act would protect Americans’ privacy and ease compliance burdens on employers. Among other steps, it would modernize communication by allowing employers to electronically file certain documents. It would also protect privacy by clarifying that the IRS can accept full names and dates of birth in lieu of dependents’ and spouses’ Social Security numbers. In addition, it would ease compliance burdens by extending the time period (from 30 days to 90 days) during which an applicable large employer can appeal a penalty for not offering adequate, affordable health insurance to all full-time employees. Finally, it would enact a six-year statute of limitations for the IRS to levy penalties under the Employer Shared Responsibility provision of the ACA.
The Paperwork Burden Reduction Act would reduce the number of physical forms that employers have to mail to employees as part of complying with the ACA. Currently, employers and health insurance providers that provide minimum essential coverage must report this information to the IRS for each covered individual and provide a copy of this information to the covered individual (through 1095-B or 1095-C tax forms, depending on the coverage type) by January 31 of each year. Current IRS regulations allow employers to provide only 1095-B forms electronically. The Paperwork Burden Reduction Act would codify the current IRS policy by allowing the 1095-B to be provided electronically and would extend this to 1095-C, limiting unnecessary physical paperwork.
“The Partnership for Employer-Sponsored Coverage (P4ESC) applauds introduction of the Employer Reporting Improvement Act and the Paperwork Burden Reduction Act in the Senate. We thank the bill’s bipartisan sponsors, Senators Warner, Thune, Cortez Masto, and Young. We are particularly grateful to Senator Warner, who has championed this issue ever since the Affordable Care Act became law. P4ESC hopes that 2023 finally will be the year ACA reporting gets fixed,” said Neil Trautwein, P4ESC’s Executive Director.
“The IRS’s employer reporting requirements offer a significant, complex challenge to Virginia small businesses and employees. With new legislation, Congress can take immediate action to relieve employers and employees of this annual reporting burden and unintended tax implications. We thank Senator Warner and his colleagues for advancing bipartisan, streamlined solutions with these bills,” said Eric Terry, President, Virginia Restaurant, Lodging & Travel Association.
“We commend Senators Thune, Warner, Young, and Cortez Masto for introducing the Employer Reporting Improvement Act in the Senate. This is a breath of fresh air that small businesses desperately need. By allowing electronic filing of essential documents and promoting flexibility, this legislation slices through bureaucratic barriers, protecting small businesses from being overly exposed to unwarranted fines. It's not just about reducing unnecessary paperwork; it’s about empowering small business owners with the flexibility they need to better support their valued employees,” said Josselin Castillo, Manager of Federal Government Relations, National Federation of Independent Business (NFIB). “The Paperwork Reduction Act, introduced by Senators Warner, Young, Cortez Masto, and Thune, takes a significant step towards providing relief for small business owners from unnecessary red tape. By offering alternative reporting methods, this legislation reduces cumbersome red tape and drives efficiency. This legislation promotes badly needed flexibility and streamlines operations, lowering costs and helping small employers focus on what they do best, running their businesses and supporting their employees.”
Nov 02 2023
Today, U.S. Sens. Mark R. Warner (D-VA), Chairman of the Senate Select Committee on Intelligence, Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, John Cornyn (R-TX), and Maggie Hassan (D-NH) launched a bipartisan working group to examine and propose potential legislative solutions in the HELP Committee jurisdiction to strengthen cybersecurity in the health care and public health sector. This effort comes at a time of record cybersecurity attacks on health care entities. Health records, unlike other personal records like credit card numbers, are more valuable on the black market since health conditions are permanent and cannot be reissued.
According to the Department of Health and Human Services (HHS), a record 89 million Americans have already had their health information breached, more than double since last year. These cyberattacks severely impact health care operations, costing an average of $10 million per breach and leading to an interruption or long-term delay in care. Last year in Louisiana, hackers compromised almost 270,000 personal records, including health information.
“As Chairman of the Senate Select Committee on Intelligence, I am acutely aware of the most serious threats facing our country, and I know that shoring up our cybersecurity is one of the best tools we have to protect ourselves and our sensitive materials. In no industry is this more obvious and important than health care, where such care is increasingly connected and even a brief period of interruption can have life and death consequences. I am proud to launch this bipartisan group to build on the policy options I have been exploring and better improve our cybersecurity through legislative fixes,” said Sen. Warner.
“We are seeing a disturbing rise in cyberattacks on our health care system. These attacks not only put patients’ sensitive health data at risk but can delay life-saving care,” said Dr. Cassidy. “Just like a strong military and police force defends us against physical attacks, we must ensure health institutions can safeguard against increasing cyber threats and protect Americans’ crucial health data.”
“Cyberattacks on health care organizations threaten the security of patients’ private medical information and can interrupt the delivery of critical care,” said Sen. Cornyn. “I am eager to join my colleagues in looking for solutions that shield our health care institutions and Americans from these dangerous crimes.”
“Hospitals and doctor’s offices are increasingly facing cyberattacks that threaten to expose patients’ medical information and even shut down ERs,” said Sen. Hassan. “This is a particularly pressing challenge for rural doctors and hospitals, which often don’t have the resources necessary to protect against these threats. I am glad to join this bipartisan working group to find effective, commonsense ways to protect medical providers and patients from cyberattacks.”
WASHINGTON – Today, U.S. Sens. Mark R. Warner and Tim Kaine (both D-VA) announced that the U.S. Economic Development Administration (EDA) selected two projects in Virginia as part of the first phase of EDA’s Regional Tech Hubs Program.
The Tech Hubs Program, made possible by the CHIPS and Science Act, bipartisan legislation strongly supported by both senators, aims to strengthen U.S. economic and national security by investing in regions across the country that have the assets, resources, and potential to become globally competitive innovation centers focused on the technologies and industries of the future. Specifically, this U.S. Department of Commerce program brings together diverse public, private, and academic partners into collaborative consortia focused on driving inclusive regional growth. With their existing innovation assets as a foundation, these Tech Hubs are envisioned to build the workforce of the future, enable businesses to start and scale, and deploy and deliver critical and emerging technologies.
In the Richmond/Petersburg region, the Advanced Pharmaceutical Manufacturing Tech Hub was designated as one of 31 inaugural Tech Hubs in regions across the country that show potential for rapid growth in key technology sectors. Led by the Commonwealth Center for Advanced Manufacturing, this consortium will ensure that critical pharmaceuticals are manufactured here in America by employing regional assets, scientific capacities, and public and private investment to accelerate the growth, innovation, and sustainability of the U.S.-based pharmaceutical manufacturing industry. This comes as increasing overseas manufacturing creates supply chain vulnerabilities and difficulties in pharmaceutical quality regulation and monitoring. The designation of the Richmond/Petersburg region as a Tech Hub builds off last year’s award of $52.9 million from the EDA’s Regional Challenge program to the Virginia Advanced Pharma Manufacturing (APM) Cluster, led by the Virginia Biotechnology Research Partnership Authority and located in the Richmond/Petersburg region. That award, dedicated to expanding the domestic supply chain for essential medicines and critical active pharmaceutical ingredients, was made possible by the American Rescue Plan that the senators voted for and by the senators’ efforts to advocate directly for the project.
“The CHIPS and Science Act continues to deliver significant wins for Virginia, supporting the creation of an Advanced Pharmaceutical Manufacturing Tech Hub in the Richmond-Petersburg region. I was proud to support this project, which will help make the Richmond-Petersburg region a critical hub for the manufacturing of advanced pharmaceuticals. Today’s announcement will help boost the American pharmaceutical industry while creating 21st century jobs for Virginians,” said Sen. Warner.
“Manufacturing critical medicines, including insulin, in America is good for patients, our workers, our economy, and the stability of our supply chains. That’s why I’ve worked for decades to boost our biotechnology sector in the Richmond region. I helped form and grow the Virginia Biotechnology Research Partnership Authority, a leader of this project, while I was on Richmond City Council, served on the Authority’s board while I was Richmond’s mayor, and appointed its board members while I was governor. Now as Senator, I worked to secure funding from the American Rescue Plan for the project and pushed to make this competitive Tech Hub designation possible. I’ll keep working to advance this critical economic development project for Central Virginia,” said Sen. Kaine.
This designation is part of the first phase of the novel Tech Hubs program that will invest directly in high-potential U.S. regions and aim to transform them into globally competitive innovation centers. Designation is an endorsement of the region’s strategy to supercharge their respective technological industry to create jobs and strengthen U.S. economic and national security. Designated Tech Hubs are now eligible to apply for the next phase of the Tech Hubs Program that will invest between $50 and $75 million in each of 5-10 Designated Hubs. The consortium was selected from 198 applications from regional consortia that include industry, academia, state and local governments, economic development organizations, and labor and workforce partners. The Tech Hubs span regions across 32 states and Puerto Rico and represent a cross section of urban and rural regions.
In the New River Valley and Danville, the Virginia Additive Manufacturing and Applied Materials Strategy Development Consortium was awarded a Strategic Development Grant, which will go towards advancing a regional strategy based in the New River Valley to develop and deploy additive manufacturing system technologies for heavy industry to re-shore manufacturing and to strengthen domestic supply chain resilience.
“Today’s selection of Virginia’s Additive Manufacturing and Applied Materials Strategy Development Consortium as a Tech Hubs Strategy Development Grant recipient is great news for the New River Valley, Southside, and for the Commonwealth as a whole. I am proud to have supported this application and look forward to continuing the growth of the regions’ innovation economy,” said Sen. Warner. “The CHIPS & Science Act, which I was proud to author and lead through Congress, continues to bring high-paying, competitive jobs to Virginia.”
“Last month, I visited MELD manufacturing in Christiansburg and saw up close the strength of Virginia’s Additive Manufacturing and Applied Materials Strategy Development Consortium. Today’s exciting announcement by the U.S. Department of Commerce is a recognition of the incredible work Virginians have already accomplished through this partnership, and their great potential for job creation in the future. As Seapower Chair on the Senate Armed Services Committee, I am particularly impressed with how these innovations will enhance our national security. I will continue to do all that I can to support economic development in the New River Valley and applaud the innovators there that keep Virginia at the cutting-edge,” said Sen. Kaine.
Led by the New River Valley Regional Commission, this consortium will leverage the grant to increase local coordination and planning activities to strengthen the region’s capacity to manufacture, commercialize, and deploy technologies critical to U.S. economic and national security. This consortium was selected for a grant from a competitive pool of 181 applications.
The mission of the U.S. Economic Development Administration (EDA) is to lead the federal economic development agenda by promoting competitiveness and preparing the nation’s regions for growth and success in the worldwide economy. An agency within the U.S. Department of Commerce, EDA invests in communities and supports regional collaboration in order to create jobs for U.S. workers, promote American innovation, and accelerate long-term sustainable economic growth.
WASHINGTON, D.C. – Today, U.S. Senators Mark R. Warner and Tim Kaine applauded the announcement that all 10 drug manufacturers whose drugs were selected for price negotiation with Medicare have agreed to participate in the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. The Inflation Reduction Act, which the senators helped pass last year, allows the Centers for Medicare and Medicaid Services’ (CMS) to negotiate prescription drug prices for the first time in history, which will help lower costs for millions of Americans.
In August, CMS announced the first 10 drugs covered under Medicare Part D—among the costliest for the Medicare program without generic competition—that will be eligible for the program. The drug manufacturers had until October 1 to decide whether to participate in negotiations or face penalties. Nationwide, Medicare enrollees covered under Part D paid a total of $3.4 billion in out-of-pocket costs in 2022 for these 10 drugs. In Virginia, Medicare Part D enrollees have more than 193,000 active prescriptions for these 10 medications.
“Too many Americans aren’t able to afford the medications they need, and that’s why we fought to include a provision in the Inflation Reduction Act to allow Medicare to negotiate prescription drug prices,” said the senators. “Today’s announcement that all 10 drug manufacturers will participate in the Inflation Reduction Act’s drug price negotiation program is a positive step towards lowering prescription drug costs for millions of seniors. We’re glad that the program continues to progress and look forward to seeing its full impacts in the years ahead.”
Under the law, CMS will negotiate directly with drug companies, and the first set of negotiated prices will go into effect on January 1, 2026. CMS will then select up to 15 more Part D drugs eligible for negotiation for 2027 and will continue to build on this progress in subsequent years by negotiating prices of more prescription drugs. The Congressional Budget Office (CBO) has estimated that the drug price negotiation program will lower Medicare spending by $98.5 billion over 10 years.
Warner and Kaine have championed policies to lower the cost of prescription drugs and long fought to allow CMS and to negotiate drug prices for those on Medicare. The senators repeatedly introduced legislation to allow Medicare to negotiate the best price of prescription drugs for seniors enrolled in Medicare Part D. Additionally, Warner, a member of the Senate Finance Committee, helped author the Modernizing and Ensuring PBM Accountability (MEPA) Act, bipartisan legislation approved by the Committee in July 2023 to help address rising prescription drug prices by regulating the middlemen who manage prescription drug benefits on behalf of health insurers and which included key provisions authored by Warner.
Kaine, a member of the Senate Health, Education, Labor, & Pensions (HELP) Committee, previously introduced legislation that would allow Medicare to negotiate drug prices for Medicare Exchange plans, created under his Medicare-X Choice Act, and the Medicare Part D program. In May 2019, he gave a speech on the Senate floor highlighting stories from Virginians from Martinsville, Norfolk, Arlington, and Virginia Beach who have been hurt by the high cost of prescription drugs and calling for reforms to bring drug prices down. In May 2023, he voted to pass the bipartisan Pharmacy Benefit Manager Reform Act, legislation to lower drug costs, out of the HELP Committee. He has also authored and cosponsored bills to strengthen the pipeline and increase transparency for critical medicines and more efficiently usher drugs to the market by making key improvements to the Food and Drug Administration’s review process for interchangeable biosimilars.
Warner, Kaine & Colleagues Urge Biden Administration to Strengthen Protections Against “Junk” Insurance Plans
Sep 19 2023
WASHINGTON – U.S. Sens. Mark R. Warner and Tim Kaine, a member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, joined Senators Tammy Baldwin (D-WI), Bernie Sanders (I-VT) and Ron Wyden (D-OR) in calling on the Biden Administration to swiftly enact and continue to strengthen a proposed rule to limit the availability of short-term limited duration insurance (STLDI) plans, which are commonly referred to as “junk plans.” Junk plans provide inadequate coverage and deny coverage to people with pre-existing conditions.
In July, following pressure from Sens. Warner, Kaine, and their colleagues, the Biden Administration released new draft regulations to roll back a 2018 Trump Administration effort that made junk plans more widely available to consumers. Since 2018, these plans have continued to proliferate. However, they are not required to adhere to important standards, including protections for people with pre-existing conditions and coverage for essential health benefits like maternity care or mental health services. Once finalized, the Biden Administration’s rule will restore a 90-day limit on the use of junk plans, instead of the current four-year maximum, so they can only be used on a temporary basis as intended, such as when people are transitioning from one plan to another.
In a letter to Department of Health and Human Services Secretary Xavier Becerra, Department of Labor Acting Secretary Julie Su, and Department of Treasury Secretary Janet Yellen, the senators urged the Biden Administration to swiftly enact the proposed rule, continue to strengthen protections, and increase transparency on junk plans to protect Americans from this inadequate coverage.
“We applaud your efforts to protect Americans who may have been duped into these junk plans, and urge the Biden Administration to swiftly finalize the rule and bolster our collective efforts to expand access to affordable, comprehensive health coverage,” wrote the senators. “With this new proposal, the Biden Administration is taking action to better protect consumers and promote access to affordable, comprehensive health insurance.”
In addition to expressing support for the Biden Administration’s proposed rule, the senators urged administration leaders to take further measures to protect consumers as they finalize the new rule on STLDI plans, including cracking down on the practice of “stacking,” or repeatedly enrolling the same consumer in junk plans across different issuers. The senators also called on the Biden Administration to bring greater transparency to junk plans through disclosure and reporting requirements and to consider additional protections for individuals shopping for coverage during the annual Open Enrollment period, which is set to begin November 1.
“For too long, junk plans were able to proliferate unchecked, resulting in increased exposure to financial harm for consumers. By finally limiting the duration of these plans and providing better protections for consumers, we are helping ensure that when families spend their hard-earned dollars on health insurance, they get the high-quality coverage they deserve,” concluded the senators.
Joining Sens. Warner, Kaine, Baldwin, Sanders, and Wyden in signing the letter were Senators Michael Bennet (D-CO), Richard Blumenthal (D-CT), Cory Booker (D-NJ), Bob Casey (D-PA), Catherine Cortez Masto (D-NM), Dianne Feinstein (D-CA), Maggie Hassan (D-NH), John Hickenlooper (D-CO), Ben Ray Luján (D-NM), Ed Markey (D-MA), Robert Menendez (D-NJ), Christopher Murphy (D-CT), Alex Padilla (D-CA), Jeanne Shaheen (D-NH), Tina Smith (D-MN), Debbie Stabenow (D-MI), Chris Van Hollen (D-MD), Elizabeth Warren (D-MA), and Peter Welch (D-VT).
A full version of the letter is available here and below.
Dear Secretaries Becerra, Su, and Yellen:
We write in support of the Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury’s (collectively, the Departments’) long-awaited proposal to address short-term limited duration insurance (STLDI) plans. In 2018, the previous administration sought to sabotage the Affordable Care Act (ACA) by expanding access to STLDI plans that can deny coverage to people with preexisting conditions and fail to provide adequate health care coverage when Americans need it most. While STLDI plans have their purpose, such plans provide junk coverage when compared to high-quality, comprehensive coverage. We applaud your efforts to protect Americans who may have been duped into these junk plans, and urge the Biden Administration to swiftly finalize the rule and bolster our collective efforts to expand access to affordable, comprehensive health coverage.
In 2018, regulations issued by the previous administration rewrote the definition of STDLI coverage, allowing these plans to expand their term of coverage from three months to 364 days with the option to renew for up to three years. Unlike marketplace plans, STLDI plans are not required to comply with consumer protections that limit out-of-pocket costs or coverage of essential health benefits, including mental health services, treatment for substance-use disorder, prescription drugs, and maternity care. Furthermore, these plans engage in discriminatory practices, such as retroactive coverage rescissions, medical underwriting, and lifetime and annual caps, which were commonplace before the ACA. Since 2018, many consumers shopping for coverage may not have understood that they were buying a plan that puts them at risk for pre-existing conditions and coverage gaps.
With this new proposal, the Biden Administration is taking action to better protect consumers and promote access to affordable, comprehensive health insurance. We appreciate the Department’s efforts to hold true to a definition of “short-term” that is just that – short term. STLDI policies were originally intended to temporarily fill gaps in coverage while people transition between jobs or when students were required to disenroll from student health coverage over the summer months. As such, we believe these plans should be strictly limited to three months without the option for extensions.
We also strongly support the proposal to prevent insurance companies or brokers from repeatedly enrolling the same consumer in STLDI coverage, a practice known as “stacking,” and request that the Administration do more to prohibit stacking of STLDI plans across different issuers. In addition, as we continue to ensure that Americans have access to affordable coverage, it is critically important for Congress, state regulators, researchers, stakeholders, and federal departments to understand the true impact of the junk insurance market on the ACA marketplaces and other forms of high-quality coverage. As a part of this rulemaking, we strongly urge the agencies to implement policies that would bring greater transparency to these products including disclosure and reporting requirements for intermediary entities such as brokers, associations, and lead generators.
Finally, we urge the Administration to consider additional protections for individuals who may be shopping for coverage during the ACA’s annual Open Enrollment (OE) period.
Fraudsters, always looking for opportunities to take advantage of consumers, are enrolling individuals into plans without their consent, and numerous studies have documented the use of deceptive and misleading marketing to lure consumers into junk plans. We urge the Departments to proactively work with state insurance commissioners to address misleading marketing practices. High-quality insurance coverage is now more affordable than ever before thanks to the enhanced premium tax credits passed as part of the American Rescue Plan Act and the Inflation Reduction Act, as well as the Administration’s efforts to fix the “family glitch” which eliminated the subsidy cliff that impacted over five million Americans. It is our responsibility to ensure that the OE period, which is set to begin on November 1, is as successful as possible in promoting access to high-quality, affordable coverage.
For too long, junk plans were able to proliferate unchecked, resulting in increased exposure to financial harm for consumers. By finally limiting the duration of these plans and providing better protections for consumers, we are helping ensure that when families spend their hard-earned dollars on health insurance, they get the high-quality coverage they deserve.
Sep 13 2023
WASHINGTON – Today, U.S. Sens. Mark R. Warner (D-VA) and John Thune (R-SD) led a group of colleagues in a letter to Anne Milgram, Administrator of the Drug Enforcement Administration (DEA), expressing support for the agency’s new engagement on a potential special registration for telehealth but sharing serious concerns over the agency’s proposed rules on the future of prescribing controlled substances via telehealth. Despite efforts by Sen. Warner to ensure continued access to telehealth services following the end of the COVID-19 Public Health Emergency (PHE), the DEA’s rules as proposed would drastically affect patient care.
Joining Sens. Warner and Thune in this letter are U.S. Sens. Catherine Cortez Masto (D-NV), Shelley Moore Capito (R-WV), Sheldon Whitehouse (D-RI), and Dan Sullivan (R-AK).
At the start of the pandemic, the DEA acted swiftly to take advantage of exceptions detailed in the Ryan Haight Online Pharmacy Consumer Protection Act that allowed the agency to waive in-person requirements for prescribing controlled substances in the case of a Public Health Emergency (PHE). With the expiration of the COVID-19 PHE earlier this year, however, the DEA announced a proposed rule detailing their plans for prescribing these medications via telehealth going forward that would limit the ability of doctors to prescribe controlled substances without an in-person visit and place unnecessary requirements on care providers. The proposed rule would only allow a 30-day supply of a schedule III-V non-narcotic medication prior to an in-person medical evaluation, and would not permit any initial supply for schedule II or schedule III-V narcotic medication.
The senators wrote, “Although we appreciate the limited flexibilities proposed by the rule, they are insufficient to meet the health care needs of our constituents and the needs of the providers who care for them. We support the Drug Enforcement Administration (DEA) extending the full set of telehealth flexibilities through November 2023 and are encouraged by the upcoming public listening sessions on the proposed regulations. We urge the DEA to consider feedback from health care stakeholders and apply the lessons learned from the COVID-19 pandemic to ensure patients maintain access to care through telehealth, while still minimizing diversion and fraud.”
Highlighting the difficulty patients have scheduling in-person appointments, the senators continued, “We have concerns about our constituents’ ability to obtain in-person appointments within 30 days of starting a new medication, and the potential consequences to their health of starting a new medication and abruptly ending it should they not be able to obtain such an appointment. It takes on average 26 days to schedule a new patient appointment with a health care provider. Therefore, a 30-day supply could result in patients going without their medication while they wait for an in-person appointment or will turn to higher-acuity and higher-cost settings of in-person care to meet this deadline, such as emergency departments.”
The senators also called attention to a rule Congress created as part of the SUPPORT for Patients and Communities Act that requires the DEA create a registration for telemedicine practitioners who would not be subject to mandatory in-person medical evaluations. The goal of this special registration is to allow medical evaluations over telehealth more broadly, which the senators state this DEA rule does not accomplish.
Over the course of the COVID-19 pandemic, tremendous progress was made to ensure that patients could receive care without interruption. Reinstating these hard limits on telehealth would be taking a step backwards, and have serious impacts on the care options for thousands of patients. Sen. Warner has consistently led efforts to expand telehealth accessibility, introducing legislation to expand telehealth services and repeatedly calling on congressional leadership to extend telehealth services after the end of the pandemic.
A copy of the letter is available here and text is below:
Dear Administrator Milgram:
On behalf of our constituent patients, health care providers, and pharmacists, we’re writing to share strong concerns with the notice of proposed rulemaking on the future of controlled substances prescribing over telehealth. Although we appreciate the limited flexibilities proposed by the rule, they are insufficient to meet the health care needs of our constituents and the needs of the providers who care for them. We support the Drug Enforcement Administration (DEA) extending the full set of telehealth flexibilities through November 2023 and are encouraged by the upcoming public listening sessions on the proposed regulations. We urge the DEA to consider feedback from health care stakeholders and apply the lessons learned from the COVID-19 pandemic to ensure patients maintain access to care through telehealth, while still minimizing diversion and fraud.
As you know, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Ryan Haight Act”) offered seven exceptions to the in-person medical evaluation requirement when providers are engaged in the “practice of telemedicine;” a public health emergency is one such exception, and we’re grateful the DEA moved swiftly to utilize that exception during the COVID-19 pandemic.
However, we are concerned that the proposed rule undermines the gains made during the PHE that saw expanded access to critical health care services through telehealth
Initial supply: Prior to an in-person medical evaluation, the proposed rule permits a DEA-registered prescriber to provide an initial 30-day supply of a controlled substance for non-narcotic schedule III-V medications. We have concerns about our constituents’ ability to obtain in-person appointments within 30 days of starting a new medication, and the potential consequences to their health of starting a new medication and abruptly ending it should they not be able to obtain such an appointment. It takes on average 26 days to schedule a new patient appointment with a health care provider. Therefore, a 30-day supply could result in patients going without their medication while they wait for an in-person appointment or will turn to higher-acuity and higher-cost settings of in-person care to meet this deadline, such as emergency departments.
Despite the 180-day grace period after the end of the PHE, new and existing patients will be seeking in-person appointments simultaneously in a health care system that is already burdened by a shortage of health care providers. According to the U.S. Department of Health and Human Services, 163 million Americans live in Mental Health Care Health Professional Shortage Areas. Approximately 8,200 additional psychiatrists would be needed nationwide just to remove this shortage designation. Nationwide averages also obscure the variation among states and territories; for example, Arizona has only 8.5% of its psychiatric health care needs met and would need 227 psychiatrists to meet 100% of these needs. And beyond mental health care, 100 million Americans live in Primary Care Health Professional Shortage Areas, with more than 17,000 primary care providers needed at a minimum to remove the designation.
Medical societies representing health care providers and their patients nationwide have encouraged a window of longer than 30 days for an initial prescription in order to provide enough time to obtain an appointment: the American Medical Association (AMA) and the American Psychiatric Association recommend 180 days, with the Association of American Medical Colleges (AAMC) urging no less a 90-day maximum when the provider believes it is appropriate. In addition, the AMA and the AAMC recommend that existing patients have one year to fulfill the in-person appointment requirement.
Provider safety: The proposed rule requires the prescribing provider to report their physical address at the time of the telemedicine appointment. Health care providers have shared they sometimes do telemedicine appointments from their home and have safety and privacy concerns with their home address being on the prescription. We urge you to allow providers to use the business address of their DEA registration.
- Referring providers: The proposed rule requires that an in-person medical evaluation be performed by a DEA-registered provider before a referral to another DEA-registered provider who would be permitted to prescribe a controlled substance over telehealth. We are concerned that individuals without adequate in-person access to a DEA-registered provider will see their health care treatment options limited should they be referred to a specialist for a telehealth appointment, or instead a second in-person medical evaluation would be required with a DEA-registered provider prior to seeing a specialist, which would increase costs to the patient and the health care system as a whole. We urge you to work with health care providers to ensure patients do not encounter any truly unnecessary barriers to care.
- Prescribing practitioner: The proposed rule requires a referring provider to specifically include the name and National Provider Identifier (NPI) of the prescribing practitioner to which the referring prescriber is referring the patient. In practice, patients are often referred to a group practice where they see whichever specialist has a first available appointment. Or, referrals may not have a provider indicated at all, as the patient often has to explore insurance network coverage and new patient availability. This requirement may prevent patients from receiving the legitimate health care services they need.
Recordkeeping: Finally, we have heard widespread concerns about additional recordkeeping and other administrative burdens required from providers and pharmacies. This additional administrative burden will strain an already exhausted workforce could also deter providers from being able to provide this care. Stakeholders have shared that existing recordkeeping requirements should be sufficient for the purpose of DEA being able to combat diversion and fraud, and we encourage you to work with providers on the least burdensome path forward.
In addition to the PHE exception to the Ryan Haight Act discussed above, Congress also created a “special registration” exception, not as an option for DEA to utilize but a requirement to do so most recently in the SUPPORT for Patients and Communities Act (“SUPPORT Act”). We do not believe this NPRM fulfills DEA’s obligation to create a special registration.
Congress envisioned this special registration to allow certain health care providers to be cleared and registered to use their clinical judgment when a medical examination can be done over telehealth for the purposes of a controlled substances prescription. DEA envisioned this to be the case, as well: in the preamble to Ryan Haight Act implementation regulations, DEA wrote:
“Special registration for telemedicine—a practitioner who is engaged in the practice of telemedicine within the meaning of the Act is not subject to the mandatory in-person medical evaluation requirement of 21 U.S.C. 829(e) (although such practitioner remains subject to the requirement that all prescriptions for controlled substances be issued for a legitimate medical purpose.”
Although we appreciate DEA not requiring a special registration for the initial prescriptions currently proposed, we are concerned that the proposed rule does not include the special registration directed to be created by Congress and even envisioned by the DEA. However, we are pleased to see DEA recently indicate further consideration of a special registration process that would allow clinicians to prescribe a controlled substance via telemedicine without an in-person visit. We appreciate the continuation of the comment process via public listening sessions, and encourage the DEA to review and incorporate stakeholders’ feedback in future rulemaking related to telemedicine prescribing.
In addition to allowing qualified health care providers to determine when a medical evaluation over telehealth is appropriate, a special registration would also provide a framework to evaluate the appropriateness of certain prescribers having the ability to prescribe over telehealth medications not covered by the post-COVID-19 proposed rule, namely Schedule II medications and Schedule III-V narcotic medications.
Health care providers across the board continue to ask for a special registration process that would provide a pathway for certain providers to provide more care involving controlled substances over telehealth than the proposed rule allows, and we implore DEA to follow its statutory requirements under the Ryan Haight Act and the SUPPORT Act and do just that.
Thank you for your consideration of these concerns, and we look forward to continuing to work with you on these important issues.
Warner & Kaine Applaud Nearly $940,000 in Federal Funding to Support Those Recovering from Substance Use Disorder in Southwest Virginia
Sep 11 2023
WASHINGTON– Today, U.S. Sens. Mark R. Warner and Tim Kaine announced $939,669 in federal funding to help people in recovery from substance use disorder rejoin the workforce in Southwest Virginia. The funding was awarded by the Appalachian Regional Commission’s Investments Supporting Partnerships in Recovery Ecosystems (INSPIRE) Initiative, which provides funding across Appalachia to address the substance use disorder crisis.
“In addition to expanding access to substance use treatment programs, it's critical that we're helping individuals recovering from substance use disorders access the resources they need to succeed,” said the senators. “We’re glad this funding will help more Virginians across Southwest Virginia get the job skills and support they need to enter or renter the workforce.”
The funding is distributed as follows:
- $500,000 for the YWCA Northeast Tennessee and Southwest Virginia in Glade Spring to provide access to family resiliency and recovery-to-work supports, including workshops on health and wellness, soft skills and entrepreneurship, personal finance, housing, career coaching, teen and adult parenting, and nutrition and cooking.
- $439,669 for Mountain Empire Community College Foundation in Big Stone Gap to grow their Project Amelioration Program, which helps individuals with substance use disorder in Dickenson, Lee, and Wise counties gain hands-on job training, financial education, and life skills training. The program also offers counseling services, social services, and employment assistance.
Sens. Warner and Kaine, a member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, have long supported those recovering from substance use disorder. The senators announced $1.4 million in federal funding to expand access to mental health care across Virginia.
Warner & Kaine Announce $1.4 Million in Federal Funding to Expand Access to Mental Health Care in Virginia
Aug 25 2023
WASHINGTON – Today, U.S. Sens. Mark R. Warner and Tim Kaine announced $1,398,428 in federal funding for the Virginia Department of Behavioral Health and Developmental Services to expand access to mental health care in Virginia. The funding was awarded by the U.S. Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration’s (SAMHSA) Community Mental Health Services Block Grant program. This program allocates funding to states to provide comprehensive, community-based mental health services to adults and children with significant mental health conditions.
“Every Virginian deserves access to high-quality, affordable mental health care,” said the senators. “The last few years have underscored the importance of access to mental health services, and we’re glad this funding will help more Virginians reach the care they need.”
States may distribute funds from this program to local government entities and nongovernmental organizations to provide community mental health services. The funding was made possible by the (BSCA), which the senators helped pass. In Fiscal Year 2023, Virginia has received over $25 million in federal funding through the Community Mental Health Services Block Grant program.
Warner and Kaine have long supported efforts to expand access to mental health care. Warner and Kaine are sponsors of the CONNECT for Health Act, which would expand coverage of telehealth services, including mental health treatment and treatment for substance use disorders. Warner has additionally successfully pressed the Drug Enforcement Agency (DEA) to finalize long-delayed regulations allowing doctors to prescribe controlled substances, including those that treat opioid use disorder, through telehealth. Kaine, a member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, introduced legislation to reduce and prevent suicide, burnout, and mental and behavioral health conditions among health care professionals, which President Biden signed into law last year. Last year, the senators announced $1 million in federal funding through the BSCA to expand and enhance the 988 Suicide & Crisis Lifeline in Virginia. Kaine has also introduced legislation to support children’s access to mental health care, which was included in last year’s government funding bill that the senators helped pass.
WASHINGTON – U.S. Sen. Mark R. Warner (D-VA), Chairman of the Senate Select Committee on Intelligence, today urged Google CEO Sundar Pichai to provide more clarity into his company’s deployment of Med-PaLM 2, an artificial intelligence (AI) chatbot currently being tested in health care settings. In a letter, Sen. Warner expressed concerns about reports of inaccuracies in the technology, and called on Google to increase transparency, protect patient privacy, and ensure ethical guardrails.
In April, Google began testing Med-PaLM2 with customers, including the Mayo Clinic. Med-PaLM 2 can answer medical questions, summarize documents, and organize health data. While the technology has shown some promising results, there are also concerning reports of repeated inaccuracies and of Google’s own senior researchers expressing reservations about the readiness of the technology. Additionally, much remains unknown about where Med-PaLM 2 is being tested, what data sources it learns from, to what extent patients are aware of and can object to the use of AI in their treatment, and what steps Google has taken to protect against bias.
“While artificial intelligence (AI) undoubtedly holds tremendous potential to improve patient care and health outcomes, I worry that premature deployment of unproven technology could lead to the erosion of trust in our medical professionals and institutions, the exacerbation of existing racial disparities in health outcomes, and an increased risk of diagnostic and care-delivery errors,” Sen. Warner wrote.
The letter raises concerns over AI companies prioritizing the race to establish market share over patient well-being. Sen. Warner also emphasizes his previous efforts to raise the alarm about Google skirting health privacy as it trained diagnostic models on sensitive health data without patients’ knowledge or consent.
“It is clear more work is needed to improve this technology as well as to ensure the health care community develops appropriate standards governing the deployment and use of AI,” Sen. Warner continued.
The letter poses a broad range of questions for Google to answer, requesting more transparency into exactly how Med-PaLM 2 is being rolled out, what data sources Med-PaLM 2 learns from, how much information and agency patients have over how AI is involved in their care, and more.
Sen. Warner, a former tech entrepreneur, has been a vocal advocate for Big Tech accountability and a stronger national posture against cyberattacks and misinformation online. In April, Sen. Warner directly expressed concerns to several AI CEOs – including Sundar Pichai – about the potential risks posed by AI, and called on companies to ensure that their products and systems are secure. Last month, he called on the Biden administration to work with AI companies to develop additional guardrails around the responsible deployment of AI. He has also introduced several pieces of legislation aimed at making tech more secure, including the RESTRICT Act, which would comprehensively address the ongoing threat posed by technology from foreign adversaries; the SAFE TECH Act, which would reform Section 230 and allow social media companies to be held accountable for enabling cyber-stalking, online harassment, and discrimination on social media platforms; and the Honest Ads Act, which would require online political advertisements to adhere to the same disclaimer requirements as TV, radio, and print ads.
A copy of the letter can be found here are below.
Dear Mr. Pichai,
I write to express my concern regarding reports that Google began providing Med-PaLM 2 to hospitals to test early this year. While artificial intelligence (AI) undoubtedly holds tremendous potential to improve patient care and health outcomes, I worry that premature deployment of unproven technology could lead to the erosion of trust in our medical professionals and institutions, the exacerbation of existing racial disparities in health outcomes, and an increased risk of diagnostic and care-delivery errors.
Over the past year, large technology companies, including Google, have been rushing to develop and deploy AI models and capture market share as the technology has received increased attention following OpenAI’s launch of ChatGPT. Numerous media outlets have reported that companies like Google and Microsoft have been willing to take bigger risks and release more nascent technology in an effort to gain a first mover advantage. In 2019, I raised concerns that Google was skirting health privacy laws through secretive partnerships with leading hospital systems, under which it trained diagnostic models on sensitive health data without patients’ knowledge or consent. This race to establish market share is readily apparent and especially concerning in the health care industry, given the life-and-death consequences of mistakes in the clinical setting, declines of trust in health care institutions in recent years, and the sensitivity of health information. One need look no further than AI pioneer Joseph Weizenbaum’s experiments involving chatbots in psychotherapy to see how users can put premature faith in even basic AI solutions.
According to Google, Med-PaLM 2 can answer medical questions, summarize documents, and organize health data. While AI models have previously been used in medical settings, the use of generative AI tools presents complex new questions and risks. According to the Wall Street Journal, a senior research director at Google who worked on Med-PaLM 2 said, “I don’t feel that this kind of technology is yet at a place where I would want it in my family’s healthcare journey.” Indeed, Google’s own research, released in May, showed that Med-PaLM 2’s answers contained more inaccurate or irrelevant information than answers provided by physicians. It is clear more work is needed to improve this technology as well as to ensure the health care community develops appropriate standards governing the deployment and use of AI
Given these serious concerns and the fact that VHC Health, based in Arlington, Virginia, is a member of the Mayo Clinic Care Network, I request that you provide answers to the following questions.
- Researchers have found large language models to display a phenomenon described as “sycophany,” wherein the model generates responses that confirm or cater to a user’s (tacit or explicit) preferred answers, which could produce risks of misdiagnosis in the medical context. Have you tested Med-PaLM 2 for this failure mode?
- Large language models frequently demonstrate the tendency to memorize contents of their training data, which can risk patient privacy in the context of models trained on sensitive health information. How has Google evaluated Med-PaLM 2 for this risk and what steps has Google taken to mitigate inadvertent privacy leaks of sensitive health information?
- What documentation did Google provide hospitals, such as Mayo Clinic, about Med-PaLM 2? Did it share model or system cards, datasheets, data-statements, and/or test and evaluation results?
- Google’s own research acknowledges that its clinical models reflect scientific knowledge only as of the time the model is trained, necessitating “continual learning.” What is the frequency with which Google fully or partially re-trains Med-PaLM 2? Does Google ensure that licensees use only the most up-to-date model version?
- Google has not publicly provided documentation on Med-PaLM 2, including refraining from disclosing the contents of the model’s training data. Does Med-PaLM 2’s training corpus include protected health information?
- Does Google ensure that patients are informed when Med-PaLM 2, or other AI models offered or licensed by, are used in their care by health care licensees? If so, how is the disclosure presented? Is it part of a longer disclosure or more clearly presented?
- Do patients have the option to opt-out of having AI used to facilitate their care? If so, how is this option communicated to patients?
- Does Google retain prompt information from health care licensees, including protected health information contained therein? Please list each purpose Google has for retaining that information.
- What license terms exist in any product license to use Med-PaLM 2 to protect patients, ensure ethical guardrails, and prevent misuse or inappropriate use of Med-PaLM 2? How does Google ensure compliance with those terms in the post-deployment context?
- How many hospitals is Med-PaLM 2 currently being used at? Please provide a list of all hospitals and health care systems Google has licensed or otherwise shared Med-Palm 2 with.
- Does Google use protected health information from hospitals using Med-PaLM 2 to retrain or finetune Med-PaLM 2 or any other models? If so, does Google require that hospitals inform patients that their protected health information may be used in this manner?
- In Google’s own research publication announcing Med-PaLM 2, researchers cautioned about the need to adopt “guardrails to mitigate against over-reliance on the output of a medical assistant.” What guardrails has Google adopted to mitigate over-reliance on the output of Med-PaLM 2 as well as when it particularly should and should not be used? What guardrails has Google incorporated through product license terms to prevent over-reliance on the output?
Statement of U.S. Sen. Mark R. Warner on DEA's Consideration of a Rule Allowing Certain Controlled Substances to be Prescribed via Telehealth
Aug 04 2023
WASHINGTON – U.S. Sen. Mark R. Warner (D-VA) today released the following statement on a notice by the Drug Enforcement Agency (DEA) that it will consider creating a special registration process that would allow quality health care providers to prescribe controlled substances over telehealth safely, as they’ve done during the pandemic. Sen. Warner has been a vocal advocate for telehealth and has previously called on the DEA to establish this process.
“Telehealth was a lifesaver for patients during the peak of the pandemic and has since opened the door to uncomplicated and reliable access to a doctor for patients who need it. Given the shortage of mental health providers and the increased need for access to prescribers through telehealth, I’m pleased that the DEA is finally looking into establishing a rule to allow specially trained prescribers to continue administering controlled substances virtually without requiring an in-person visit. This rule will be especially meaningful to patients who rely on medications that treat opioid use disorder, among many others. I encourage prescribers and patients to participate in the DEA’s public comment period and provide their input on this proposed rule.”
Since 2008, Congress has directed the DEA to set up a special registration process, an exception process under the Ryan Haight Act, a law that regulates the online prescription of controlled substances. This special registration process would open up the door for quality health care providers to evaluate a patient and prescribe these medications over telehealth safely, as was done for years during the pandemic.
Sen. Warner, a former tech entrepreneur, has been a longtime advocate for increased access to telehealth. He is an original cosponsor of the CONNECT for Health Act, which would expand coverage of telehealth services through Medicare, make COVID-19 telehealth flexibilities permanent, improve health outcomes, and make it easier for patients to safely connect with their doctors. He previously wrote to both the Biden and Trump administrations, urging the DEA to finalize regulations long-delayed by prior administrations allowing doctors to prescribe controlled substances through telehealth. Sen. Warner also sent a letter to Senate leadership during the height of the COVID-19 crisis, calling for the permanent expansion of access to telehealth services.
In 2018, Sen. Warner included a provision to expand financial coverage for virtual substance use treatment in the Opioid Crisis Response Act of 2018. In 2003, then-Gov. Warner expanded Medicaid coverage for telemedicine statewide, including evaluation and management visits, a range of individual psychotherapies, the full range of consultations, and some clinical services, including in cardiology and obstetrics. Coverage was also expanded to include non-physician providers. Among other benefits, the telehealth expansion allowed individuals in medically underserved and remote areas of Virginia to access quality specialty care that isn’t always available at home.
Warner & Kaine Announce Nearly $11 Million in Federal Funding to Expand Access to Health Care in Rural Virginia
Jul 26 2023
WASHINGTON– Today, U.S. Sens. Mark R. Warner and Tim Kaine announced $10,968,600 in federal funding to expand access to health care in the Valley and Southwest Virginia. The funding was awarded by the U.S. Department of Agriculture’s (USDA) Community Facilities Emergency Rural Health Care Grant Program, which helps rural health care facilities, tribes, and communities expand access to health care services and nutrition assistance. The funding was made possible by the American Rescue Plan, which Warner and Kaine voted to pass in 2021.
“All Virginians, no matter where they live, should have access to high-quality, reliable health care,” said the senators. “We’re glad this funding will help expand telehealth services, improve capacity for mental health and substance use treatment programs, and update essential medical equipment so that more Virginians can get the care they need.”
The funding is distributed as follows:
- $5,118,100 for the Virginia Consortium to Advance Health Care in Appalachia to increase access to telehealth by expanding regional networks that will share resources, training, and educational opportunities for people living in rural areas throughout the Commonwealth. The Consortium includes the University of Virginia’s (UVA) Center for Telehealth, the Healthy Appalachia Institute at UVA’s College at Wise, the Southwest Virginia Health Authority, the Health Wagon, Tri-Area Health, and Ballad Health.
- $5,000,000 for the Mount Rogers Community Services (MRCS) Smyth County campus to expand access to mental health, developmental disability, and substance use disorder treatment. The funding will be used to create a second eight-bed unit at the Rhea B. Lawrence Recovery Center, which will double the space available for residential services. It will also be used to relocate the crisis care center from an offsite facility to centralize treatments and offer referral-based outpatient services in one location. These steps will help improve the quality of care available to the 32,208 residents located in the Center’s service area, which includes Bland, Carroll, Grayson, Smyth, and Wythe counties and Galax.
- $850,500 for the Bath County Community Hospital to purchase an X-ray machine and an electronic medical records system subscription, which will give doctors quick access to health records from labs and clinic emergency rooms. The equipment was damaged in an electrical fire, forcing staff to use a portable machine that is inadequate in many cases. The equipment will benefit nearly 30,000 residents in Bath, Highland, and Alleghany counties.
Warner and Kaine have long supported efforts to expand access to health care, especially in rural communities. The senators have introduced the CONNECT for Health Act of 2023, which would expand coverage of telehealth services through Medicare, make permanent telehealth flexibilities that were enacted during COVID, make it easier for patients to connect with their doctors, and help improve health outcomes. In March, the senators introduced the Save Rural Hospitals Act, which would help curb the trend of hospital closures in rural communities by making sure hospitals are fairly reimbursed for their services by the federal government.
WASHINGTON — The Senate Finance Committee today approved on a 26-1 vote the Modernizing and Ensuring PBM Accountability (MEPA) Act, bipartisan legislation to help address rising prescription drug prices by regulating the middlemen who manage prescription drug benefits on behalf of health insurers.
“For too long, and without any transparency, pharmacy middlemen have moved away from their origins negotiating to bring prices down on behalf of insurers and consumers and have instead moved toward extracting profit, leading to higher drug prices, more federal spending, and bigger out-of-pocket costs for Virginians,” said Sen. Warner, a member of the Committee and a co-author of the legislation. “The Inflation Reduction Act we enacted last year finally gave Medicare the power to negotiate prices for some of the most expensive prescription drugs for seniors on Medicare, but Congress needs to do more to lower the price of medicines, including through reforms to PBMs. I’m proud of our work today in the Finance Committee, and am hopeful that we can bring a bill to the Senate floor and get it to the president’s desk soon.”
Included in the legislation are multiple bipartisan bills proposed by Sen. Warner, including S. 2493, the PBM Reporting Transparency Act, which would hold PBMs accountable for providing good value to seniors and Medicare by making public information about the contracts between PBMs and Medicare prescription drug plans; S. 2408, the IMPROVE Part D Regulations Act, which would require the Centers for Medicare & Medicaid Services (CMS) to conduct patient-focused listening sessions about potential improvements to Medicare Part D; and an amendment requiring CMS to make sure that PBMs aren’t standing in the way of fair reimbursements for smaller pharmacies, such as long-term care pharmacies and home infusion pharmacies, that serve medically complex patients.
WASHINGTON — Today, U.S. Sens. Mark R. Warner (D-VA) and John Thune (R-SD) introduced the Equitable Community Access to Pharmacist Services Act, bipartisan legislation that would ensure seniors can continue to access certain clinical services from their pharmacist. The bill would allow Medicare to reimburse for certain pharmacist-administered tests, treatments, and vaccinations for influenza, respiratory syncytial virus (RSV), COVID-19, and strep throat, in accordance with state scope-of-practice laws.
“Pharmacists play a key role in delivering health care services in our communities,” said Sen. Warner. “This legislation will make care for common illnesses – including flu, COVID, RSV, and strep throat – easier for seniors to access by allowing pharmacists to seek reimbursement from Medicare for services that they are already licensed to perform under state laws, such as testing and vaccination.”
“Seniors across South Dakota rely on the care and support they receive from their community pharmacist,” said Sen. Thune. “I am proud to lead this common-sense legislation that would allow these trusted sources for vaccinations and other important treatments to remain a reliable option for seniors.”
“We extend our heartfelt appreciation to Senator Thune for introducing the Equitable Community Access to Pharmacists Services Act,” said Amanda Bacon, executive director of the South Dakota Pharmacists Association. “This groundbreaking legislation will make an incredible difference in increasing access to essential healthcare services provided by pharmacists across South Dakota. By recognizing the critical role pharmacists play in patient care and fostering collaboration with other healthcare providers, Senator Thune is paving the way for a healthier and more vibrant future for our communities.”
“Pharmacists are a vital part of the rural health care delivery system as many older adults in rural areas depend on their pharmacist to help manage multiple prescriptions and conditions,” said Alan Morgan, CEO of the National Rural Health Association (NRHA). “The Equitable Community Access to Pharmacist Services Act would remove barriers for older adults in rural areas to access essential pharmacist services related to respiratory illnesses, which tend to be more fatal for older populations. NRHA is proud to support this legislation to ensure rural communities maintain access to pharmacist services and care to help older adults manage their health.”
Manchin, Brown, Casey Fetterman, Warner, Kaine Statement on DOL Proposed Rule to Reduce Silica Dust Exposure
Jun 30 2023
Washington, DC – U.S. Senators Joe Manchin (D-WV), Sherrod Brown (D-OH), Bob Casey (D-PA), John Fetterman (D-PA), Mark Warner (D-VA) and Tim Kaine (D-VA) released the following statement on the Department of Labor’s (DOL) proposal by its Mine Safety and Health Administration (MSHA) to amend current federal standards to better protect the nation’s miners from health hazards related to exposure to respirable crystalline silica, or silica dust.
“We applaud the Mine Safety and Health Administration’s new proposed silica rule to enhance health protections for miners across the country. We urge swift implementation of this rule because protecting our hard-working miners from dangerous levels of silica cannot wait. After decades of declining rates of black lung deaths, we have seen the number of reported cases rapidly increase over the last 20 years - especially in Appalachia. America’s coal miners have risked their lives to power our great nation for generations, and we are committed to using every tool possible to protect miners from developing debilitating diseases that are entirely preventable.”
Earlier this month, the Senators sent a letter to Office of Management and Budget (OMB) Director Shalanda Young, seeking additional information on the delayed announcement of a new silica standard for miners across America and urging prompt promulgation.
Jun 15 2023
WASHINGTON — Today, U.S. Sen. Mark R. Warner (D-VA), co-chair of the Congressional Task Force on Alzheimer’s Disease, announced that a pair of bills that would build on the important progress that has been made to prevent and effectively treat Alzheimer’s disease advanced the Senate Health, Education, Labor, and Pensions (HELP) committee by a 20-1 vote.
More than six million Americans are living with Alzheimer’s. Alzheimer’s costs our nation an astonishing $345 billion per year, including $222 billion in costs to Medicare and Medicaid. If we continue along this trajectory, Alzheimer’s is projected to claim the minds of 13.8 million seniors by 2060 and nearly surpass $1 trillion in annual costs by 2050. In 2022, family caregivers provided 18 billion hours of unpaid care for loved ones with dementia.
“I lost my mother to Alzheimer’s after a courageous decade-long fight, so I understand the toll this terrible disease takes on seniors and families,” said Sen. Warner. “Today’s resounding bipartisan vote is a great step towards reauthorizing some of the most powerful tools we have to find a cure for Alzheimer’s. I look forward to getting it across the finish line.”
The NAPA Reauthorization Act—authored by Sen. Susan Collins (R-ME) and co-led by Sens. Warner, Shelley Moore Capito (R-WV), Ed Markey (D-MA), Jerry Moran (R-KS), Bob Menendez (D-NJ), Lisa Murkowski (R-AK), and Debbie Stabenow (D-MI)—would reauthorize the National Alzheimer’s Project through 2035 and modernize the legislation to reflect strides that have been made to understand the disease, such as including a new focus on promoting healthy aging and reducing risk factors. The National Alzheimer’s Project brings the whole of government together to make recommendations to improve policies and care for individuals with Alzheimer’s disease and their caregivers and families.
The Alzheimer’s Accountability and Investment Act—also authored by Sens. Collins, Warner, Capito, Markey, Moran, Menendez, Murkowski, and Stabenow—would continue through 2035 a requirement that the Director of the National Institutes of Health submit an annual budget to Congress estimating the funding necessary to fully implement NAPA’s research goals. Only two other areas of biomedical research – cancer and HIV/AIDS – have been the subject of special budget development aimed at speeding discovery.
The NAPA Reauthorization Act and Alzheimer’s Accountability and Investment Act are endorsed by the Alzheimer’s Association and UsAgainstAlzheimer’s. The NAPA Reauthorization Act, as reported out of Committee, also includes updated language in recognition of the need to include underserved populations, including individuals with Down syndrome, who are at increased risk for Alzheimer’s as they age. The reported bill is endorsed by the National Down Syndrome Society, the National Down Syndrome Congress, and LuMind IDSC Foundation.
Lawmakers Reintroduce Bipartisan, Bicameral Legislation to Increase Access to Medicare Home Infusion Benefit
Jun 14 2023
WASHINGTON – U.S. Sens. Mark R. Warner (D-VA) and Tim Scott (R-SC) joined by U.S. Reps. Vern Buchanan (R-FL-16), Chairman of the House Ways & Means Health Subcommittee, Debbie Dingell (D-MI-06), Diana Harshbarger (R-TN-01), and Terri Sewell (D-AL-07) today reintroduced legislation that will ensure patients maintain access to home infusion therapy. The Preserving Patient Access to Home Infusion Act protects access to Medicare’s home infusion benefit by making clear that pharmacy services for home infusion therapy can be reimbursed and sets an appropriate rate for such services.
“We have seen for years that patients are better off when they can receive quality care from the comfort of their own homes,” said Sen. Warner. “This legislation would ensure that millions of Americans who suffer from life threatening conditions such as immune diseases, cancer, serious infections, and heart failure can receive the care they need without having to make frequent, sometimes costly trips to the hospital.”
“High-risk patients who are more susceptible to contracting disease shouldn’t have to visit a hospital and further risk their health to receive life-saving treatment,” said Sen. Scott. “This commonsense legislation ensures that millions of Americans have the option to receive the care they need in the comfort and safety of their own homes.”
“The coronavirus pandemic taught us that home health services are invaluable for seniors in my district and across the country,” said Rep. Buchanan. “The aptly-named Preserving Patient Access to Home Infusion Act will ensure that Medicare recipients can continue to receive life-saving drugs in a safe and effective way from the comfort and convenience of their own home.”
“We know that the majority of people would prefer to receive care in the home when possible, and over the last few years, we have seen the effective expansion of many home care services, which can result in significant savings for patients and providers” said Rep. Dingell. “The legislation’s commonsense reforms will expand access to home infusion services for Medicare beneficiaries, saving the Medicare program millions of dollars, cutting patient costs, and ensuring people receive safe and adequate care in the comfort of their own home. I look forward to working with my colleagues to move this bipartisan legislation forward so we can effectively care for people and save money by doing so in a home setting.”
“For Medicare patients living in rural areas, regular visits to healthcare providers to receive infusion services often prove to be costly and burdensome,” said Rep. Harshbarger. “It is critical that common-sense reforms are passed to address CMS’ flawed implementation of home-based care for Medicare patients, which is why I am proud to co-sponsor the Preserving Patient Access to Home Infusion Act. This legislation is vital to our many seniors who receive infusion treatments, ensuring patients have access to effective therapies from the safety and comfort of their homes, while producing cost-savings for both the Medicare program and patient.”
“Countless Alabamians, especially those in rural communities, rely on home infusion services for life-saving care,” said Rep. Sewell. “It has never been more critical to ensure that patients continue to receive this care safely in their homes. I’m so proud to introduce this bipartisan bill and urge my colleagues on both sides of the aisle to give it their full support.”
Sen. Warner originally included provisions in the 21st Century Cures Act and the Bipartisan Budget Act of 2018 to create a professional services benefit for Medicare Part B home infusion drugs in order to maintain patient access to home infusion by covering professional services including assessments, education on administration and access device care, monitoring and remote monitoring, coordination with the patient, caregivers and other health care providers, and nursing visits.
Despite Congress’ intent, the Centers for Medicare and Medicaid Services (CMS) improperly implemented the benefit by requiring a nurse to be physically present in the patient’s home in order for providers to be reimbursed. As a result, provider participation in Medicare’s home infusion benefit has dropped sharply and beneficiaries have experienced reduced access to home infusion over the last several years.
The Preserving Patient Access to Home Infusion Act provides technical clarifications that will remove the physical presence requirement, ensuring payment regardless of whether a health care professional is present in the patient’s home. The legislation also acknowledges the full scope of professional services provided in home infusion — including essential pharmacist services — into the reimbursement structure.
Specifically the legislation would:
- include pharmacy services as part of covered home infusion therapy under Medicare, encompassing assessments, drug preparation and compounding, and care coordination and documentation;
- direct CMS to pay 50% of the nursing rate on home infusion days when a nurse is not present;
- allow nurse practitioners and physician assistants to establish and review the plan of care for home infusion therapy.
“The National Home Infusion Association (NHIA) applauds Senator Warner and Senator Scott for their leadership on common sense legislation that will ensure Medicare patients have access to home infusion therapy,” said Connie Sullivan, NHIA’s President and CEO. “Americans have overwhelmingly demonstrated they prefer to receive medical treatments at home when given the option — and this legislation marks an important step in making that option available to our Medicare beneficiaries.”
A copy of the bill text is available here.
May 22 2023
WASHINGTON – Today, U.S. Sens. Mark R. Warner (D-VA) and Tim Scott (R-SC) reintroduced bipartisan legislation to protect seniors by empowering nursing homes to better screen and vet potential employees. The Ensuring Seniors’ Access to Quality Care Act would allow nursing home operators to access the National Practitioner Data Bank (NPDB) – a national criminal background check system – to verify the records of potential caregivers and ensure they do not run the risk of endangering the seniors they are employed to look after. Currently, senior living facilities are not authorized to use the NPDB and instead must rely on state-level criminal background checks that can often omit key details about an employee’s background.
“Seniors are some of the most vulnerable people in our society. As they get older and come to rely on assistance, they deserve quality and compassionate care from professionals who have the adequate experience and temperament,” said Sen. Warner. “This legislation will provide senior living facilities with the tools they need to hire staff without sacrificing quality care.”
“Skilled nursing facilities across the country care for thousands of Americans as they live out their golden years. Ensuring these facilities can hire and train the best caregivers and provide exceptional service to for seniors - at no cost to the taxpayer - is a common sense, life-changing solution for our loved ones,” said Sen. Scott.
This legislation also amends overly restrictive regulations that bar certain senior living facilities from conducting training programs for in-house Certified Nurse Assistants (CNAs) – individuals who assist patients with their daily activities. Under existing regulations by the Centers for Medicare and Medicaid Services (CMS), senior living facilities found to have deficiencies, such as poor conditions or patient safety violations, are automatically prohibited from conducting CNA staff training programs for a period of two years, even if they have fixed the problem.
This lockout period can make it more difficult for senior care facilities to properly train new employees and retrain existing staff – a particularly concerning challenge given projections by the Bureau of Labor and Statistics, which estimates that the need for nursing assistants and orderlies is projected to rise 5 percent from 2021 to 2031. With this growing need for caregivers, in-house CNA education at senior living facilities often helps meet the need for CNAs.
Specifically, this legislation would allow a senior living facility to reinstate its CNA training program if:
- The facility has corrected the deficiency for which the CMP was assessed;
- The deficiency for which the CMP was assessed did not result in an immediate risk to patient safety and is not the result of patient harm resulting from abuse or neglect;
- And the facility has not received a repeat deficiency related to direct patient harm in the preceding two year period;
This legislation has the support of the American Health Care Association/National Center for Assisted Living, LeadingAge, LeadingAge Virginia, and LeadingAge South Carolina.
“I started my career as a CNA in a facility training program. I know how important it is to keep this pathway for hands-on training open to ensure we have caregivers for seniors,” said Derrick Kendall, Chairman of Virginia Health Care Association – Virginia Center for Assisted Living (VHCA-VCAL), and President & CEO of Lucy Corr of Chesterfield. “The demand for CNAs has never been greater, so it’s time to end this barrier to training more, especially when a facility has addressed the reason for the lockout.”
“Having access to the National Practitioner Data Bank would be extremely beneficial for us. It would help prevent bad actors from hopping from state to state,” said Melissa Green, Chief Clinical Officer of Trio Health Care, LLC, Hot Springs, VA, and a nursing home operator who has facilities close to neighboring states. She cites an incident when it was revealed that an employee had stolen an identity to work as a nurse—without access to the NPDB there was no way to know the actual nurse’s identity was stolen even though the nursing home completed the required background checks.
“We commend Senators Warner and Scott for reintroducing this important legislation at this critical moment for the long term care workforce. In the midst of a historic labor crisis, we need solutions like the Ensuring Seniors’ Access to Quality Care Act to help nursing homes vet and train crucially needed caregivers. By allowing facilities the ability to offer CNA training programs and access to the National Practitioner Data Bank, we can ensure our nation’s seniors receive high quality care delivered by highly-trained and dedicated caregivers,” said Mark Parkinson, President and CEO of the American Health Care Association/National Center for Assisted Living.
“Certified nurse aides (CNAs) are integral to the quality care that nursing homes provide; more are desperately needed. LeadingAge and our nonprofit mission-driven members support every opportunity to recruit and train new CNAs. This legislation will do just that by helping to alleviate a longstanding barrier to training and by ensuring the availability of onsite programs to build potential employees’ knowledge and skills,”said Katie Smith Sloan, president and CEO of LeadingAge. “In addition to providing a solid educational foundation, these training programs also serve as an introduction to aging services, exposing students to nursing homes’ daily work routines and community cultures. They’re critical. Particularly now, when nursing homes are in dire need of more staff, we must leverage every possible opportunity to bring qualified workers into the sector and build workforce pipelines to help deliver quality care for our country’s aging population. This Senate bill is a much-appreciated recognition of these issues and will help to resolve longstanding workforce shortages. We appreciate the support of Senators Warner and Scott, and we are eager to work with them and their House colleagues in moving these bills forward.”
“The dedication and compassion of CNAs are crucial in ensuring that older Americans receive the best possible care and quality of life. Part of our role is to provide training and essential services so they can continue to provide daily care, comfort, and compassion. We appreciate both Senators Warner and Scott’s work on alleviating this strain on our mission-driven providers,” said Dana Parsons, Vice President and Legislative Counsel of LeadingAge Virginia.
“CNAs are the backbone of caring for older Americans, providing essential services that allow seniors to live with dignity and independence. It is necessary for them to continue to have the hands-on training they need as they are the heart of long-term care,” said Josh Bagley, Executive Director of The View Alexandria by Goodwin Living, Alexandria, VA.
“It is through Senator Tim Scott’s determination and vision of a better future for our citizens that we can begin to correct the antiquated barriers to quality care that this bill seeks to address. Innovation and creation is cultivated through sound policies that give the freedom to our nation’s providers to enrich our field of service in ways uniquely appropriate for our diverse nation. This bill would be a meaningful and powerful catalyst to ensure proper training for those who care for our nation’s older adults, particularly as we continue to face workforce shortages in the long-term care sector. I remain proud of Senator Scott’s support and focus on a better path forward for all,” said David Buckshorn, Chairperson for LeadingAge South Carolina, and CEO of Wesley Commons.
Full text of the bill is available here.
May 16 2023
WASHINGTON – Today, during Brain Cancer Awareness Month, U.S. Sens. Mark Warner, Tim Kaine (both D-VA), and Jerry Moran (R-KS) introduced the Gabriella Miller Kids First Research Act 2.0. This legislation would provide a new source of funding for the National Institutes of Health’s (NIH) Gabriella Miller Kids First Pediatric Research Program (Kids First)—which Kaine helped create—by redirecting penalties collected from pharmaceutical, cosmetic, supplement, and medical device companies that break the law to pediatric and childhood cancer research. Congresswoman Jennifer Wexton (D-VA-10) introduced a version of the legislation in the U.S. House of Representatives.
The bill is named in honor of Gabriella Miller, a Leesburg, Virginia resident who died from a rare form of brain cancer at the age of 10. Miller was an activist and worked to raise support for research into childhood diseases like cancer until her death in October of 2013. In 2014, Kaine honored her by championing the Gabriella Miller Kids First Research Act, which established a Ten-Year Pediatric Research Initiative at the NIH and authorized $12.6 million per fiscal year through FY23 for pediatric disease research. Since President Barack Obama signed the original bill in 2014, $126 million has been directed to pediatric cancer research at the NIH through the Gabriella Miller Kids First Research program.
“I can think of no better way to honor the memory of Gabriella and other children who have lost their lives to rare pediatric cancers than by passing this legislation, which would provide crucial, sustainable funding for research to advance lifesaving treatments,” said Sen. Warner.
“Gabriella Miller was a Virginian and a passionate activist, and it’s my mission to honor her by working to make sure pediatric disease research is a priority in Congress,” said Sen. Kaine, who serves on the Senate Health, Education, Labor and Pensions Committee. “I’m proud to join together with colleagues from both sides of the aisle in introducing this legislation, which would provide a crucial source of funding for the pediatric cancer and disease research that can support treatments and save lives in the years to come.”
“Cancer is the leading cause of death by disease among children, and we must better understand this horrific disease,” said Sen. Moran. “By directing new resources to NIH to research cures and treatments for cancer in children, we can help save lives and honor the memory of Gabriella Miller.”
“It is unacceptable that less than 8% of the federal cancer research funding goes towards childhood cancer while tens of thousands of children are diagnosed each year in the U.S. – and cancer is taking more children’s lives than any other disease right now,” said Rep. Wexton. “I’m proud to lead this bipartisan, bicameral legislation to build on the remarkable work of the Kids First research programs and boost funding for treatments and cures that can save kids’ lives. It’s been an honor to work with Ellyn Miller, a constituent and Gabriella’s mother, as well as my colleagues on both sides of the aisle to deliver real change so no family has to go through what the Millers have faced.”
While cancer is the leading cause of death by disease among children past infancy, childhood cancer and other rare pediatric diseases remain poorly understood. According to the National Cancer Institute, an estimated 9,910 children under the age of 14 will be diagnosed with cancer, and about 1,040 will die of the disease in the United States in 2023.
The Gabriella Miller Kids First Research Program has supported critical research into pediatric cancer and structural birth defects and has focused on building a pediatric data resource combining genetic sequencing data with clinical data from multiple pediatric cohorts. The Gabriella Miller Kids First Data Resource Center is helping to advance scientific understanding and discoveries around pediatric cancer and structural birth defects and has sequenced nearly 20,000 samples thus far.
The legislation is also cosponsored by U.S. Sens. Martin Heinrich (D-NM), Marco Rubio (R-FL), Tina Smith (D-MN), Steve Daines (R-MT), Peter Welch (D-VT), Shelley Moore Capito (R-WV), Ted Budd (R-NC), and Chris Van Hollen (D-MD).
You can view the full bill text here.
May 11 2023
WASHINGTON – U.S. Sen. Mark R. Warner (D-VA) released the statement below on the official end of the nation’s Public Health Emergency (PHE) for COVID-19:
“When COVID-19 hit, Congress acted with force and urgency to save lives and livelihoods, taking actions that were made possible by the Public Health Emergency declaration, which opened the door to a wealth of additional tools and flexibilities. More than three years later, I’m proud to know that our nation has reached a point where we can move beyond the emergency stage of COVID-19 and the corresponding PHE declaration. Now, it’s up to Congress to adopt more permanent policies that reflect the valuable lessons we learned during this crisis, and that allow us to move forward rather than backwards. We must continue to strengthen our public health response capabilities, ensure that health care is affordable and easy to access through robust telehealth options, and improve the security of our southwest border while creating a better functioning asylum process and a reasonable path towards legal status for those who are undocumented. I look forward to working with my colleagues in Congress on these issues.”
Statement of U.S. Sen. Mark R. Warner on DEA Extension of Current Flexibilities Around Telehealth Prescriptions of Certain Medications
May 03 2023
WASHINGTON – U.S. Sen. Mark R. Warner (D-VA) released the statement below after the Drug Enforcement Agency (DEA) announced that it would extend current flexibilities around telehealth prescriptions of controlled substances, including those that treat opioid use disorder and anxiety, while it reviews a record number of comments received in response to its new proposed telemedicine rules. This move follows strong advocacy by Sen. Warner, who spoke out in March about the need to ensure that patients can continue getting their medications and sent a letter to DEA in August 2022 asking them to explain their plan for continuity of care after the COVID-19 Public Health Emergency.
“I’m pleased to see that the DEA is taking additional time to consider the comments to their proposed rule, which I believe overlooked the key benefits and lessons learned during the pandemic. This proposed rule could counterproductively exacerbate the opioid crisis and push patients to seek dangerous alternatives to proper health care, such as self-medicating, by removing a telehealth option in many cases. I’m working with my colleagues in Congress on a response to DEA’s proposed rule, and I look forward to further robust discussion on this critical issue.”
During COVID-19, patients widely adopted telehealth as a convenient and accessible way to get care remotely. This was made possible by the COVID-19 Public Health Emergency, which allowed for a number of flexibilities, including utilizing an exception to the in-person medical evaluation requirement under the Ryan Haight Online Pharmacy Consumer Protection Act, legislation regulating the online prescription of controlled substances. With the Public Health Emergency set to expire, patients will soon lose the ability to reap the benefits of a mature telehealth system in which responsible providers know how to take care of their patients remotely when appropriate.
Since 2008, Congress has directed the DEA to set up a special registration process, another exception process under the Ryan Haight Act, that would open up the door for quality health care providers to evaluate a patient and prescribe controlled substances over telehealth safely, as they’ve done during the pandemic. This special registration process has yet to be established, and DEA wrote they believe this proposed rule fulfills those Congressional mandates, despite not proposing such a registration.
Sen. Warner, a former tech entrepreneur, has been a longtime advocate for increased access to telehealth. He is a co-author of the CONNECT for Health Act, which would expand coverage of telehealth services through Medicare, make COVID-19 telehealth flexibilities permanent, improve health outcomes, and make it easier for patients to safely connect with their doctors. He previously wrote to both the Biden and Trump administrations, urging the DEA to finalize regulations long-delayed by prior administrations allowing doctors to prescribe controlled substances through telehealth. Sen. Warner also sent a letter to Senate leadership during the height of the COVID-19 crisis, calling for the permanent expansion of access to telehealth services.
In 2018, Sen. Warner included a provision to expand financial coverage for virtual substance use treatment in the Opioid Crisis Response Act of 2018. In 2003, then-Gov. Warner expanded Medicaid coverage for telemedicine statewide, including evaluation and management visits, a range of individual psychotherapies, the full range of consultations, and some clinical services, including in cardiology and obstetrics. Coverage was also expanded to include non-physician providers. Among other benefits, the telehealth expansion allowed individuals in medically underserved and remote areas of Virginia to access quality specialty care that isn’t always available at home.
Warner, Kaine & Colleagues Urge Appeals Court to Prevent Dangerous Ruling Threatening Access to Mifepristone from Taking Effect
Apr 12 2023
WASHINGTON – Today, following a federal district court judge’s ruling suspending the Food and Drug Administration (FDA)’s 2000 approval of mifepristone, U.S. Sens. Mark R. Warner and Tim Kaine, along with 238 other members of Congress, submitted an amicus brief urging a higher court to prevent that dangerous ruling from going into effect. Mifepristone is a safe and effective medication that has been widely used for abortion care and miscarriage management for over two decades. The Department of Justice announced on Monday that it would appeal the lower court ruling and ask the Fifth Circuit to stop the ruling from going into effect.
The lawmakers’ brief underscores that the district court ruling denies access to mifepristone in every state, posing serious health risks to pregnant patients, and jeopardizes patients’ access to other medications by threatening FDA’s drug approval process, which was mandated by Congress. Accordingly, the brief asks the Fifth Circuit to pause the district court’s order.
“The district court appears to have second-guessed FDA’s scientific determinations with cherry-picked anecdotes and studies, and on that basis, imposed a remedy that could significantly upend the status quo,” write the lawmakers in their brief.
If the Fifth Circuit allows the district court ruling to go into effect, the members stress that patients in every state may be denied access to the most common form of abortion care and a key drug used in miscarriage management. This ruling would also undermine FDA’s authority to determine the safety and efficacy of other drugs , threatening patients’ access to medications. The members also explain that Congress specifically designed FDA’s expert-driven drug approval process to ensure that the medications relied on by Americans are safe and effective. FDA followed that careful review process in its approval of mifepristone for use in 2000, and that approval has been repeatedly affirmed in the more than 20 years since.
“[T]he district court’s misguided stay under Section 705 of the Administrative Procedure Act will reduce access to abortion, exacerbating an already significant reproductive health crisis,” write the lawmakers, adding: “The consequences of the district court’s remedy could extend far beyond mifepristone, for it undermines the science-based, expert-driven process that Congress designed for determining whether drugs are safe and effective.”
“Its perilous consequences reach far beyond mifepristone. Providers and patients rely on the availability of thousands of FDA-approved drugs to treat or manage a range of medical conditions, including asthma, HIV, infertility, heart disease, diabetes, and more,” the lawmakers state.
“For the last century, a statutory scheme designed by Congress has assured the safety and effectiveness of the drugs available in the United States. At its core resides the application of scientific standards by agency experts,” the lawmakers write. “Here, FDA’s determination that mifepristone is safe and effective is based on a thorough and comprehensive review process prescribed and overseen by the legislative branch. Since mifepristone’s initial approval in 2000, FDA has repeatedly and consistently reaffirmed that the medication is safe and effective for its approved conditions of use. FDA’s process and conclusions have been validated by both Congress and the Government Accountability Office—and by the lived experience of over 5 million patients who have used the drug in the United States.”
The lawmakers conclude by asking the Fifth Circuit to stay the decision, writing: “emergency relief from the order is necessary to mitigate the imminent harm facing members of the public, many of whom rely on the availability of mifepristone for reproductive care—and many more rely on the integrity of FDA’s drug approval process for continued access to life-improving and life-saving drugs. Congress intended to—and did—vest authority in FDA to evaluate and ensure the safety and efficacy of drugs in the United States, and Amici call on this Court to give due weight to that intent.”
In addition to Warner and Kaine, the amicus brief was signed by U.S. Senators Chuck Schumer (D-NY), Patty Murray (D-WA), Bernie Sanders (I-VT), Dick Durbin (D-IL), Richard Blumenthal (D-CT), Tammy Baldwin (D-WI), Michael Bennet (D-CO), Cory Booker (D-NJ), Sherrod Brown (D-OH), Maria Cantwell (D-WA), Ben Cardin (D-MD), Tom Carper (D-DE), Bob Casey Jr. (D-PA), Chris Coons (D-DE), Catherine Cortez Masto (D-NV), Tammy Duckworth (D-IL), Dianne Feinstein (D-CA), John Fetterman (D-PA), Kirsten Gillibrand (D-NY), Maggie Hassan (D-NH), Martin Heinrich (D-NM), John Hickenlooper (D-CO), Mazie K. Hirono (D-HI), Mark Kelly (D-AZ), Angus King (I-ME), Amy Klobuchar (D-MN), Ben Ray Luján (D-NM), Edward J. Markey (D-MA), Bob Menendez (D-NJ), Jeff Merkley (D-OR), Chris Murphy (D-CT), Jon Ossoff (D-GA), Alex Padilla (D-CA), Gary Peters (D-MI), Jack Reed (D-RI), Jacky Rosen (D-NV), Brian Schatz (D-HI), Jeanne Shaheen (D-NH), Kyrsten Sinema (I-AZ), Tina Smith (D-MN), Debbie Stabenow (D-MI), Jon Tester (D-MT), Chris Van Hollen (D-MD), Raphael Warnock (D-GA), Elizabeth Warren (D-MA), Peter Welch (D-VT), Sheldon Whitehouse (D-RI), and Ron Wyden (D-OR). 190 members of the House of Representatives also signed the amicus brief.
The amicus brief is available here.
Mar 29 2023
WASHINGTON – U.S. Sen. Mark R. Warner (D-VA), released the statement below after Federal Drug Administration (FDA) today authorized the over-the-counter sale of Narcan, a nasal spray drug that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Prior to today’s action by the FDA, this lifesaving medication was available by prescription only.
“This announcement is welcome news for the communities in Virginia and across the country that have been torn apart by the opioid epidemic, including deaths from fentanyl. As we continue pursuing a comprehensive range of solutions to tackle the opioid epidemic, I applaud the FDA for acting to put this lifesaving medication in the hands of more Americans – a move that is sure to fight overdose deaths and save lives.”
WASHINGTON – Today, U.S. Sens. Mark R. Warner (D-VA) and Marsha Blackburn (R-TN), joined by Sens. Tim Kaine (D-VA), John Cornyn (R-TX), Rev. Raphael Warnock (D-GA), John Boozman (R-AR), Cindy Hyde-Smith (R-MS), and Roger Wicker (R-MS), reintroduced the Save Rural Hospitals Act - legislation to help curb the trend of hospital closures in rural communities by making sure hospitals are fairly reimbursed for their services by the federal government.
First introduced in 2020 as a response to the record number of rural hospitals that closed in the midst of the COVID-19 pandemic, 33 nationwide since 2020, the Save Rural Hospitals Act would amend the flawed Medicare Area Wage Index formula that has disproportionately harmed rural and low-income hospitals. Currently, many hospitals in rural areas lack the resources available to those in more populated areas to offer competitive salaries. Due to those salary differences, rural hospitals receive lower reimbursements from the federal government, which contributes to their lack of resources and perpetuates a harmful staffing crisis.
The Save Rural Hospitals Act would establish a national minimum of 0.85 for the Medicare Area Wage Index, which is used to adjust a hospital’s overall payment from the Medicare program on the basis of geographic differences in labor costs, to ensure that rural hospitals receive fair payment for the care they provide. In Virginia alone, 16 hospitals across the Commonwealth would benefit from this floor being put in place.
“Rural hospitals across the country and the Commonwealth of Virginia are struggling to recruit and retain quality health care professionals,” said Sen. Warner. “This legislation aims to ensure that all hospitals are able to deliver appropriate care by attracting employees and compensating them fairly for their lifesaving work – regardless of where they are located.”
“As I speak with Tennessee leaders and medical professionals, rural health care is a top priority. By establishing an appropriate national minimum to the Medicare hospital area wage index, we can help ensure rural hospitals have the resources to recruit and retain quality health care professionals. I’m pleased to join Senator Warner in this bipartisan effort,” said Sen. Blackburn.
The Save Rural Hospitals Act would offer a permanent fix to Medicare’s unfair Wage Index, which is harming rural and low-income hospitals. Earlier this year, Sens. Warner, Blackburn and a bipartisan group sent a letter to CMS Administrator Chiquita Brooks-LaSure requesting a four-year extension of the current Low Wage Index Hospital Policy, which serves as a temporary fix, raising the payments of hospitals in the bottom wage index quartile.
“Rural hospitals must have the capacity to recruit and retain high-quality professionals to serve their communities,” said Beth O’Connor, Executive Director of the Virginia Rural Health Association. “The Save Rural Hospitals Act by Senators Warner, Kaine, and Blackburn will help ensure the Commonwealth’s rural hospitals can continue to do just that.”
“The unfortunate reality is that the survival of many rural hospitals is financially endangered – nearly 200 have closed across the U.S. since 2005, including two in Virginia. Protecting rural hospitals is vital to the health and well-being of people in less populated communities across the Commonwealth and the United States so they can access essential medical services whenever they need them,” said Sean T. Connaughton, President and CEO of the Virginia Hospital & Healthcare Association. “We applaud Senator Warner for sponsoring legislation, the Save Rural Hospitals Act, that recognizes the challenging conditions facing many rural hospitals and offers a common sense approach to appropriately adjust reimbursement rates so hospitals aren’t unfairly penalized under an outdated payment methodology that fails to account for current realities.”
“As hospitals across Tennessee face unprecedented financial and workforce challenges, I applaud Senator Blackburn for her leadership on critical legislation to address the flawed area wage index that has strained Tennessee hospitals for decades. Currently 73 percent of Tennessee hospitals are below the floor the Save Rural Hospitals Act would establish. This legislation will help to level the playing field and ensure patients across Tennessee have access to the care they need.” Dr. Wendy Long, President and CEO, Tennessee Hospital Association
“In the struggle to provide health care access, rural hospitals are on the front line nationwide for large numbers of our most vulnerable citizens,” said Alan Levine, Executive Chairman and CEO of Ballad Health, an integrated delivery system in the Appalachian Highlands of Northeast Tennessee and Southwest Virginia. “The Save Our Rural Hospitals Act will fix long-standing problems in Medicare payment policy which has underpaid rural hospitals year after year, leaving many struggling financially or at worst, closing. This bill recognizes that rural hospitals are increasingly having to recruit nationwide for nurses and other staff in short supply, and Medicare’s Area Wage Index adjustments must account for that.”
A copy of the bill text is available here.