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.

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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.”

Full text of the Employer Reporting Improvement Act is available here. Full text of the Paperwork Burden Reduction Act is available here. 

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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.

Sincerely,

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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.

Proposed Rule

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.

Referrals:

• 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.

Special Registration

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.

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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.

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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.

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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.

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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.

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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.

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.

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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. 

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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.”

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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.

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