Issue: Health Care

Walorski Sponsors Legislation to Pilot Medically Tailored Meals

Walorski Sponsors Legislation to Pilot Medically Tailored Meals

Bipartisan Bill Would Establish Medicare Pilot Program to Address Link Between Diet, Chronic Illness, and Senior Health

MISHAWAKA, Ind. – U.S. Reps. Jackie Walorski (R-Ind.), Jim McGovern (D-Mass.), Roger Marshall (R-Kan.), and Chellie Pingree (D-Maine) today announced the introduction of H.R. 6774, the Medically Tailored Home-Delivered Meals Demonstration Pilot Act of 2020, a new bill that would establish a Medicare pilot program to address the critical link between diet, chronic illness, and senior health.

The bipartisan bill would help ensure nutritious meals reach medically vulnerable seniors in their homes, especially during the COVID-19 pandemic, while at the same time providing the data needed to build a more resilient and cost-effective health care system.

“Good nutrition can play a key role in improving health, especially for those living with a chronic illness,” Congresswoman Walorski said. “Getting nutritious, medically tailored meals to vulnerable seniors in their homes would not only lead to better health outcomes but also reduce health care costs in the long-term. This innovative, commonsense solution would strengthen Medicare and help older Americans thrive – especially in these challenging times.”

“There is no doubt that what we eat plays a huge role in our overall health, yet our federal policies are decades behind the science on this. We prioritize treatment instead of prevention by relying on costly hospital visits and expensive prescription drugs instead of addressing the underlying issues that lead to chronic conditions,” said Congressman Jim McGovern. “Our bill hopes to show that by providing medically tailored meals to vulnerable seniors, we can lower hospital admissions, improve outcomes, and save money. It’s time to transform America’s sick-care system into a health-care system, and I urge my colleagues on both sides of the aisle to support this important bipartisan bill.”

“As a physician for more than 25 years, I saw the importance of nutrition on the well-being of my patients,” said U.S. Congressman Roger Marshall, M.D. “Clinical evidence continues to suggest that malnutrition of protein and essential micronutrients can increase a person’s susceptibility to infections and other negative health outcomes. Several studies have shown nutrition to play a role in interrupting transmission, reducing susceptibility, and decreasing the severity of the disease symptoms. Our bill aims to provide powerful insight on how medically tailored meals can positively impact the health of seniors and produce cost savings.”

“Medically-tailored meals rely on the simple principle that access to nutritious food is foundational to good health. We’ve long understood the improved outcomes and potential savings associated with preparing healthy meals for vulnerable people. Now, when seniors and those with serious conditions are at the highest risk for contracting COVID-19, it’s more important than ever to invest in their health. As the cofounder of the bipartisan Food is Medicine Working Group with Rep. McGovern, I’m proud to be an original cosponsor of the Medically Tailored Home-Delivered Meals Demonstration Pilot Act, which would pilot the delivery of nutritious, medically-tailored meals to Medicare recipients,” said Congresswoman Chellie Pingree.

BACKGROUND

As of 2016, 62 percent of U.S. adults over the age of 65 were living with one or more chronic conditions. A poor diet contributes to COVID risks, especially for those with underlying chronic health conditions, and a growing body of research demonstrates that medically tailored meals can be a cost-effective strategy for improving health outcomes. These meals are designed by a registered dietitian or other nutrition professional and delivered to an individual living with diet-affected disease like diabetes and congestive heart failure. When included in treatment plans for individuals with complex health conditions, these meals have been shown to reduce overall health care costs by 16 percent while significantly reducing the need for hospitalizations, emergency department use, and emergency transports.

Medicare Parts A and B – covering two-thirds of Medicare enrollees – provide no coverage for medically tailored meals. This bill would take an important first step towards filling this gap by directing the Secretary of Health and Human Services to conduct a three-year demonstration pilot program to provide medically tailored meals to some of our nation’s most vulnerable Medicare enrollees. Under the demonstration, recently hospitalized Medicare enrollees with conditions such as congestive heart failure, diabetes, COPD, and kidney disease would receive a medically tailored meal intervention. This bill would provide at least two home-delivered meals per day to the qualified individual as well as any dependents under the age of 18 who reside in the household.

This pilot is separate from but could involve programs like Meals on Wheels that provide nutritious, prepared, ready-to-eat, home-delivered meals for seniors who are homebound and in great economic and medical need. Medically tailored meals would be delivered to individuals living with severe illness through a referral from a medical professional or healthcare plan.

Walorski represents the 2nd Congressional District of Indiana, serving as a member of the House Ways and Means Committee.

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Walorski Supports Immediate Economic Relief for Workers, Families, and Small Businesses

Walorski Supports Immediate Economic Relief for Workers, Families, and Small Businesses

President Signs Bipartisan Legislation That Includes Direct Cash Assistance, Expanded Unemployment Insurance, Forgivable Small Business Loans

MISHAWAKA, Ind. – U.S. Rep. Jackie Walorski (R-Ind.) today released the following statement on her support for the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which passed the House by voice vote and was signed by President Trump:

“We are fighting against an invisible enemy, and together we will defeat it.

“Coronavirus and the steps necessary to stop it are having a devastating impact on our economy, and many of our friends and neighbors are suddenly facing hardship and uncertainty. Today, Congress took action to provide immediate relief to families, workers, and small businesses so they can get through this crisis and be even stronger when it’s over.

“The bipartisan CARES Act will provide every American, except the highest earners, with $1,200 per adult and $500 per child. It will make loans available to small businesses and non-profits to maintain payroll and cover expenses like rent – and these loans will be forgiven as long as employees keep their jobs. For workers who are laid off, the bill will temporarily expand unemployment insurance – including making it available to independent contractors and self-employed individuals. And it will provide critical resources for our nation’s hospitals, health care workers, and state and local response efforts so they can keep fighting coronavirus and keep our communities safe.”

Walorski released a video statement following House passage of the bill. The video is available here.


The Coronavirus Aid, Relief, and Economic Security (CARES) Act


Relief for Workers and Families

  • Immediate Relief for American Families – American workers and families will receive a one-time check or direct deposit of $1,200 per individual or $2,400 per couple, plus $500 per eligible child. These payments will be reduced for higher earners starting at $75,000 for individuals and $150,000 for married couples. They phase out completely at $99,000 for individuals and $198,000 for married couples. Anyone with a valid Social Security number is eligible.
  • Expanded Unemployment Insurance – The CARES Act includes $250 billion to temporarily expand unemployment benefits through the end of the year. It makes self-employed individuals, independent contractors, and others eligible for unemployment during the public health emergency. It also provides an additional 13 weeks of unemployment benefits beyond what states typically allow, and it adds $600 per week across the board for each recipient for four months from through the end of July.

Assistance for Small Businesses

  • Paycheck Protection Program – The CARES Act provides $350 billion for forgivable loans to keep small businesses from going under and prevent workers from losing their jobs. These federally guaranteed loans will be available to small employers through private lenders to provide eight weeks of cash flow assistance to maintain payroll and pay rent. Independent contractors, self-employed individuals, and 501(c)3s are also eligible. If the employer maintains their payroll, the portion of the loans used for covered payroll costs, interest on mortgage obligations, rent, and utilities would be forgiven. There is also flexibility to rehire workers who have already been laid off.
  • Employee Retention Tax Credit – The Employee Retention Credit provides a refundable payroll tax credit equal to 50 percent of up to $10,000 in wages per employee (including health benefits) paid by certain employers during the coronavirus crisis.
  • Additional Main Street Assistance – SBA will pay all principal, interest and fees on all existing SBA loan products including 7(a), Community Advantage, 504, and Microloan programs for six months. The bill provides grants and funding to offer training, counseling, and assistance to small businesses affected by COVID-19. It provides $10 billion to expedite access to capital for small businesses that have applied for an SBA Emergency Economic Injury Disaster Loan (EIDL) grant. And it includes a tax reform technical correction to ensure businesses like restaurants can take advantage of full and immediate expensing for investments in improvements.

Industry Assistance to Stabilize Economy

  • Economic Stabilization – The CARES Act Provides more than $500 billion of emergency relief in the form of direct loans, loan guarantees, and tax relief to those industries hit hardest by COVID-19. These loans are to be used to keep these job creators in business so they can keep workers on the payroll. In order to protect taxpayers, there are restrictions on executive compensation, stock buybacks are prohibited for the duration of the loan, and borrowers must maintain existing payroll.

Resources to Fight Coronavirus

  • Support for Health Care Providers – The CARES Act gets more resources to health care providers quickly and expands access to care for patients. It increases Medicare reimbursement rate, including an add-on payment to hospitals for treating COVID-19 patients, and allows for accelerated payments.
  • Resources for Local and State Response – The bill provides $340 billion in funding to combat the pandemic, including $150 billion for state and local governments.
  • Supplies for Health Care Workers – It provides $16 billion for personal protective equipment, ventilators, and other supplies to be distributed to the states. It expands testing capabilities by allowing the Strategic National Stockpile to purchase swabs necessary for test kits.
  • Access Care for Patients – It boosts funding for research into new treatments and vaccines and allows the FDA to quickly approve the use of new medications. It facilitates the use of new and innovative telemedicine technology. And it allows HSAs to be used to purchase over-the-counter medicines.

Walorski represents the 2nd Congressional District of Indiana, serving as a member of the House Ways and Means Committee.

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Walorski on Medicare for All: “If You Like Your Plan – Too Bad, It’s Gone”

Walorski on Medicare for All: “If You Like Your Plan – Too Bad, It’s Gone”

Asks HHS Sec. Azar About Impact of Outlawing Private Health Insurance, Forcing Americans into One-Size-Fits-All Government Program

WASHINGTON – U.S. Rep. Jackie Walorski (R-Ind.) today criticized Democrats’ Medicare for All proposal that would eliminate private health insurance plans, including employer-sponsored coverage and Medicare Advantage, and replace it with a massive, taxpayer-funded government program.

“Ten years ago, Democrats rammed Obamacare through the Congress based on the slogan, ‘If you like your plan, you can keep it,’” Congresswoman Walorski said. “That slogan, of course, turned out to be a lie. Fast forward to today, and a majority of House Democrats have cosponsored the Medicare for All Act, which would outlaw virtually all private health insurance coverage and force every American into a one-size-fits-all government plan. So in just ten years, we went from, ‘If you like your plan, you can keep it,’ to ‘If you like your plan – too bad, it’s gone.’ What a difference a decade makes.”

Walorski asked Health and Human Services (HHS) Secretary Alexander Azar, who testified before the Ways and Means Committee, to outline the impact Medicare for All would have on America’s working families and seniors.

“It would be absolutely devastating,” Secretary Azar said. “We’ve got 180 million Americans who get their insurance through their employer or their union. Their insurance would be taken away. Collective bargaining rights that they have given up in exchange for insurance would be taken away without compensation in wages. There are 60 million seniors in Medicare. A third of them depend on private insurance, Medicare Advantage, the ever more popular private option with added often dental, vision benefits, and pharmacy benefits for them, would be taken away as part of this. It would be devastating for America’s seniors.”

Walorski also asked Azar about initiatives to improve maternal health and decrease rates of maternal mortality, as well as the need to strengthen Temporary Assistance for Needy Families (TANF).

Video of Congresswoman Walorski discussing Medicare for All and questioning Secretary Azar is available here.

Video of Congresswoman Walorski asking Secretary Azar about maternal health and TANF is available here.

Walorski represents the 2nd Congressional District of Indiana, serving as a member of the House Ways and Means Committee.

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Walorski Supports Bipartisan Protections from Surprise Medical Bills

Walorski Supports Bipartisan Protections from Surprise Medical Bills

Ways & Means Committee Approves Consumer Protections Against Surprise Medical Bills Act

WASHINGTON – U.S. Rep. Jackie Walorski (R-Ind.) today supported committee approval of the Consumer Protections Against Surprise Medical Bills Act (H.R. 5826), bipartisan legislation to protect patients from facing unexpected health care bills from out-of-network providers.

“Too many Hoosier and American families have been hit with these unexpected costly medical bills in some of their most stressful times of need,” Congresswoman Walorski said. “Our approach protects families from these unexpected medical costs by establishing a process that keeps patients out of billing disputes between providers and insurers. It is outrageous and unacceptable when hardworking Americans do everything right in both emergency and non-emergency situations and still find a financially devastating medical bill in their mailbox.”

In the Ways and Means Committee markup of the legislation, Walorski shared the stories of two Hoosiers who received care at in-network facilities but received unexpected bills from out-of-network providers through no fault of their own.

Video of Walorski’s comments can be found here.

BACKGROUND

The Ways and Means Committee approved H.R. 5826 by voice vote. The Consumer Protections Against Surprise Medical Bills Act would:

  • Protect patients from surprise medical bills for out-of-network services by prohibiting balance billing;
  • Require an advance explanation of benefits for non-emergency care that informs patients which providers will deliver treatment, the cost of these services, and provider network status; and
    Create a streamlined arbitration process for providers and insurers if they are unable to resolve a billing dispute.

Walorski represents the 2nd Congressional District of Indiana, serving as a member of the House Ways and Means Committee.

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Walorski Statement on President Trump’s State of the Union Address

Walorski Statement on President Trump’s State of the Union Address

WASHINGTON – U.S. Rep. Jackie Walorski (R-Ind.) today released the following statement on President Trump’s State of the Union Address:

“President Trump delivered an optimistic message about our country’s future and renewed his commitment to preserving and strengthening the American Dream.

“Our economy is booming, with more jobs and higher wages for hardworking Americans and new opportunities for our farmers, manufacturers, and small businesses. I stand ready to work with the president to continue building on that momentum and ensure working families have every opportunity to thrive, including by expanding access to paid family leave.

“President Trump has been steadfast as commander-in-chief in the face of national security threats from terrorists and rogue regimes, and his leadership in rebuilding our military has made our country safer. I look forward to continuing our work together to strengthen our national security, support our servicemembers, and ensure our veterans get the care and services they earned.

“The president’s agenda is one that puts the American people first and keeps our country on the path to a better, stronger, and more prosperous future. It’s time for Congress to put divisiveness and partisanship aside so we can make this bold vision a reality.”

BACKGROUND

Republicans in Congress and President Trump have worked together to achieve key victories for the American people, including:

  • Setting the stage for the strongest economy and job market in decades through historic tax cuts for working families and small businesses;
  • Passing USMCA, a historic deal to modernize North American trade and level the
  • playing field for American workers, farmers, and manufacturers;
  • Continuing the rebuilding of our military and giving servicemembers their biggest pay raise in a decade;
  • Repealing Obamacare taxes that were driving up the cost of health care, including the job-killing medical device tax and the burdensome health insurance tax;
  • Overhauling the IRS to hold its leaders accountable, modernize its IT systems, and put service to taxpayers first; and
  • Providing states the resources and flexibility needed to transform the nation’s foster care systems and put families first.

Congresswoman Walorski is committed to continuing to work with President Trump to find commonsense solutions for Hoosiers, including:

  • Helping working families thrive by passing pro-worker, pro-family legislation to expand paid family leave benefits without raising taxes or imposing inflexible mandates;
  • Investing in our nation’s infrastructure through innovative, cost-effective financing mechanisms;
  • Lowering the cost of health care and prescription drugs while expanding patient choice and supporting innovative research to find new cures;
  • Standing up for the sanctity of life and defending the unborn, including by passing the Dignity for Aborted Children Act; and
  • Ensuring our brave veterans get the care, benefits, and services they earned.

Walorski represents the 2nd Congressional District of Indiana, serving as a member of the House Ways and Means Committee.

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Walorski Introduces Bipartisan Legislation to Increase Access to Physical Therapy Treatment in Rural Areas

Walorski Introduces Bipartisan Legislation to Increase Access to Physical Therapy Treatment in Rural Areas

Bill Would Expand Access to Pain Management Treatment at Community Health Centers and Federally Qualified Health Centers

WASHINGTON – U.S. Reps. Jackie Walorski (R-Ind.) and Ron Kind (D-Wis.) this week introduced bipartisan legislation to increase access to physical therapy services at Community Health Centers (CHCs), which provide primary health services to more than 28 million people in more than 11,000 rural and urban communities nationwide.

The Primary Health Services Enhancement Act would eliminate restrictive and burdensome requirements that currently make it difficult for CHCs to provide physical therapy services. This legislation would improve access to alternative pain management treatments for patients in medically underserved areas.

“Physical therapy has proven to be a critical tool for patients to manage chronic pain and recover from injury, and it plays a major role in non-opioid alternative treatment plans,” Congresswoman Walorski said. “But far too often patients in rural and underserved communities face unnecessary barriers that prevent them from getting the treatment they need from community health centers. The bipartisan Primary Health Services Enhancement Act will give Hoosiers an affordable and convenient option to improve their quality of life and find innovative ways to treat pain.”

“Community Health Centers (CHCs) provide a lifeline to communities in Wisconsin that wouldn’t otherwise have access to essential health services close by. At CHCs, patients can receive care from physicians, nurses, and dentists, receive emergency medical help, and seek behavioral health services–they should be able to receive physical therapy without having to jump through extra hoops,” Congressman Kind said. “The Primary Health Services Enhancement Act will eliminate barriers and restrictions for services provided by physical therapists and create greater access to pain management alternatives.”

This legislation is supported by the National Association of Community Health Centers (NACHC), the National Association of Rural Health Clinics (NARHC), and the American Physical Therapy Association (APTA).

Read the bill text here.

Walorski represents the 2nd Congressional District of Indiana, serving as a member of the House Ways and Means Committee.

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Walorski Secures Permanent Repeal of Job-Killing Medical Device Tax

Walorski Secures Permanent Repeal of Job-Killing Medical Device Tax

Year-End Funding Agreement Also Boosts Defense Funding, Gives Troops Biggest Pay Raise in a Decade, Repeals Other Costly Obamacare Taxes

WASHINGTON – U.S. Rep. Jackie Walorski (R-Ind.) today applauded House passage of a year-end funding agreement that includes her bipartisan bill to permanently repeal the job-killing medical device tax. The legislative package also ends two other costly Obamacare taxes, boosts funding for our military, and gives servicemembers their biggest pay raise in a decade.

“After years of fighting Speaker Pelosi and special interests, today we’ve secured a major victory for Hoosier workers and patients across the country: permanent repeal of Obamacare’s job-killing medical device tax,” Congresswoman Walorski said. “Ending this destructive tax once and for all will protect manufacturing jobs in northern Indiana, boost research and innovation of medical technologies, and ensure patients continue to have access to the cutting-edge products they need.

“We’re also repealing two other costly Obamacare taxes that threatened to raise the cost of health care – the health insurance tax and the Cadillac tax. We’re ensuring states have the resources they need to transform their foster care systems and put families first. And we’re providing certainty and tax relief to American farmers and small businesses by extending the biodiesel tax credit and the short line railroad tax credit.

“Finally, this bill puts America’s national security first by providing the resources needed to continue the rebuilding of our military. It supports our servicemembers, veterans, and their families by providing a 3.1 percent pay raise for our troops – the largest in a decade – and fully funding the VA MISSION Act and Blue Water Navy Vietnam Veterans Act. And it will help secure the border by providing $1.375 billion in new funding for the border wall and maintaining the president’s authority to transfer funds if necessary.

“While this legislation is not perfect – it is clearer than ever that both parties need to come together to implement long-term spending reforms in order to get our national debt under control – it will protect Hoosier jobs, keep our nation’s economic momentum going, and prioritize the safety and security of the American people. This is a win for Hoosier manufacturers, farmers, workers, and families.”

BACKGROUND

Congresswoman Walorski has long fought to repeal the medical device tax, which cost tens of thousands of jobs when it was in effect from 2013 to 2017, particularly in northern Indiana. Walorski’s legislation to fully and permanently repeal the tax – the Protect Medical Innovation Act (H.R. 2207) – had more than 250 bipartisan co-sponsors, but Speaker Pelosi and House Democratic leadership repeatedly blocked a vote on the House floor this year. The 2.3 percent excise tax on lifesaving medical devices was set to return January 1, 2020, if Congress did not act. Repeal of the medical device tax will protect good-paying manufacturing jobs, encourage medical research and innovation, and ensure patients continue to have access to the lifesaving products they need.

The year-end legislative package also repeals two other damaging Obamacare taxes: the health insurance tax and the “Cadillac tax,” both of which threatened to raise health care costs for millions of Americans by health insurance plans more expensive.

In addition to providing critical tax relief, the legislation provides federal funding for the remainder of fiscal year 2020, including several key priorities for Hoosiers:

  • Prioritizes national security and continues rebuilding of our military with a $22 billion increase in defense funding;
  • Supports servicemembers and military families, including by providing a 3.1 percent pay raise for our troops – the largest in a decade;
  • Supports the U.S.-Israel alliance by providing $500 million for Israeli Cooperative programs, including Iron Dome;
  • Provides full funding for the VA MISSION Act and Blue Water Navy Vietnam Veterans Act;
  • Provides $1.375 billion in new funding for the border wall and does not restrict the president’s authority to transfer additional funds;
  • Includes Walorski’s bipartisan Family First Transition Act to provide states with the tools and resources to transform their child welfare systems and keep more children safely at home instead of placing them in foster care;
  • Advances efforts to combat opioid abuse through prevention, treatment, recovery, and law enforcement by investing $518 million in grant programs;
  • Includes the SECURE Act to make it easier for small businesses to set up retirement plans for employees and help workers save more and earlier for retirement;
  • Includes the CREATES Act to promote competition to lower the cost of prescription drugs by ensuring affordable generic and biosimilar versions of medications can enter the market;
  • Includes $1.2 billion in disaster relief for farmers and ranchers affected by severe weather and other natural disasters in 2018 and 2019;
  • Supports Hoosier soybean farmers and boosts clean energy innovation by extending the biodiesel tax credit;
  • Helps short line railroads keep rural Indiana connected to the national economy by extending the short line tax credit;
  • Maintains all pro-life protections; and
  • Retains long-standing Second Amendment protections.

The House passed H.R. 1158, which included defense and national security funding, by a vote of 297 to 120. The House passed H.R. 1865, which included repeal of Obamacare taxes, by a vote of 280 to 138. Both bills now head to the Senate.

Walorski represents the 2nd Congressional District of Indiana, serving as a member of the House Ways and Means Committee.

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Walorski Calls for Vote on Bipartisan Bill to Lower Cost of Prescription Drugs

Walorski Calls for Vote on Bipartisan Bill to Lower Cost of Prescription Drugs

House Instead Considers Speaker Pelosi’s Partisan Bill That Would Result in Fewer Cures

WASHINGTON – U.S. Rep. Jackie Walorski (R-Ind.) this week called for a vote on a bipartisan measure to lower the cost of prescription drugs, a commonsense alternative to a partisan proposal that would stifle medical innovation and lead to fewer treatments and cures.

“We all agree that prescription drug affordability is a vital issue for the American people,” Congresswoman Walorski said. “However, we shouldn’t be sacrificing new cures in the process. That’s why I support H.R. 19, the Lower Costs, More Cures Act. This bipartisan bill will lower out of pocket spending while also protecting access to new medicines and cures.”

Walorski on Wednesday spoke on the House floor in opposition to H.R. 3, a partisan bill that was written behind closed doors and would result in fewer cures, less innovation, and worse health outcomes for patients. She voted against the legislation, which passed the House on Thursday.

H.R. 19, the Lower Costs, More Cures Act, is a bipartisan alternative that includes more than 40 provisions with support from both sides of the aisle. The bill would:

  • Encourage innovation of life-saving medicines;
  • Promote more low-cost options for patients;
  • Improve transparency at the pharmacy counter;
  • Prevent drug companies from gaming the system;
  • Cap seniors’ out-of-pocket drug costs; and
  • Cut the cost of drug administration.

Video of Congresswoman Walorski speaking on the House floor is available here. The full text of her remarks is below.

“Thank you, Madam Speaker. I rise today in strong opposition to H.R. 3. This misguided, partisan legislation was written behind closed doors. It will result in fewer cures, less innovation, and worse health outcomes.

“We all agree that prescription drug affordability is a vital issue for the American people. However, we shouldn’t be sacrificing new cures in the process.

“This bill tells patients with cancer, Alzheimer’s, and other terrible diseases to keep waiting for the cures they so desperately need.

“That’s why I support H.R. 19, the Lower Costs, More Cures Act. This bipartisan bill will lower out of pocket spending while also protecting access to new medicines and cures.

“Madam Speaker, we have an important opportunity to work in a bipartisan fashion for the American people. But here we are again considering a partisan bill that has no path forward in the Senate. This has become such a disturbing trend.

“I urge my colleagues to vote against this flawed legislation so we can work together on a bipartisan solution. I yield back.”

Walorski represents the 2nd Congressional District of Indiana, serving as a member of the House Ways and Means Committee.

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Walorski Reintroduces Critical Bipartisan Legislation Ensuring Patient Access to Breakthrough Medical Products

Walorski Reintroduces Critical Bipartisan Legislation Ensuring Patient Access to Breakthrough Medical Products

WASHINGTON – U.S. Rep. Jackie Walorski (R-Ind.) today reintroduced the Ensuring Patient Access to Critical Breakthrough Products Act of 2019 (H.R. 5333). This bill would guarantee Medicare beneficiaries access to cutting-edge medical innovation by streamlining the coverage determination process and improving the availability of breakthrough devices for patients. Walorski’s bipartisan legislation is being co-led by Rep. Suzan DelBene (D-Wash.), Rep. Tony Cárdenas (D-Calif.), Rep. Gus Bilirakis (R-Fla.), Rep. Terri Sewell (D-Ala.), and Rep. Roger Marshall (R-Kan.).

“We need to remove the unnecessary barriers preventing seniors from getting the cutting-edge medical products they need, including medical devices,” Congresswoman Walorski said. “The Ensuring Patient Access to Critical Breakthrough Products Act will encourage life-saving medical innovation and expand treatment options covered by Medicare. These important reforms will open new doors for future innovative therapies and cures that will improve quality of life for seniors.”

“This hurry-up-and-wait situation makes no sense. Seniors shouldn’t have to wait unnecessarily to access medical products that can change or even save their lives,” Congresswoman DelBene said. “Guaranteeing coverage of breakthrough technologies and opening the door to coverage of new digital-based products encourages investment in the industry, facilitating innovation and future advancements.”

“It’s wrong that our seniors are forced to wait years for access to critical medical technologies,” Congressman Cárdenas said. “This bill cuts the time Medicare enrollees must wait to access revolutionary medical technology by improving the determination process for patients. This is a smart, bipartisan solution to a problem that affects millions of seniors across the United States.”

“This legislation will help millions of seniors on Medicare by ensuring more timely access to the treatments they need,” Congressman Bilirakis said. “Additionally, there are more than 600 medical device companies in our state working to develop innovative and effective products.  During a roundtable discussion in my district, I heard from many of these businesses about how these lengthy and unnecessary Medicare coverage delays create a significant barrier in bringing new products to market. This bill is about connecting patients with important devices and technologies more quickly. Additionally, it is about encouraging innovation rather than stifling it. Government has to get out of the way and streamline the payment process for effective new devices that can ultimately help improve and save lives.”

“All Americans deserve access to life-saving, breakthrough therapies and devices,” Congresswoman Sewell said. “This bill takes a critical step in the right direction to ensure that the review and approval process for breakthrough therapies doesn’t inhibit patient access to innovative and effective technologies as they come to market.”

“It is critical that Medicare beneficiaries receive timely access to innovative therapies that bring positive health outcomes,” Congressman Marshall said. “This bipartisan bill encourages the development of new medical devices to treat life-threatening illnesses by bridging the coverage gap so our seniors can actually access them. This is a common-sense initiative and I’m pleased to join this bipartisan group in working to bring innovative treatments and cures to America’s seniors.”

BACKGROUND

Currently, Medicare does not automatically cover the latest advances in medical technology, even when the products are approved through the Food and Drug Administration’s (FDA) breakthrough pathway process. Medicare’s coverage determination for FDA approved products can take up to three years, delaying vital treatments to millions of seniors. Walorski’s Ensuring Patient Access to Critical Breakthrough Products Act would require Medicare to temporarily cover all breakthrough products approved through the FDA’s breakthrough pathway for a three-year period, during which the Centers for Medicare and Medicaid Services (CMS) must make a permanent coverage determination. This allows patients to receive the most cutting-edge, innovative care as soon as it comes to market.

For a medical product to earn the FDA’s “breakthrough” designation it must meet the following criteria:

  • provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions;
  • has no approved alternatives;
  • offers significant advantages over existing approved alternatives; or
  • availability is in the best interest of patients.

H.R. 5333 also provides temporary coverage for certain breakthrough devices that did not exist or were not contemplated when Medicare was first created and do not have a Medicare benefit category. Since last Congress, the FDA has granted breakthrough status to products that do not have a benefit category in Medicare, and therefore no pathway or coverage for Medicare patients. For example, software or digital products, such as Prescription Digital Therapeutics are not eligible for Medicare coverage because today there is no appropriate benefit category. Walorski’s bill would allow the Health and Human Services (HHS) Secretary the flexibility to make coverage determinations for products that have FDA breakthrough status but no benefit category.

Walorski previously introduced the Ensuring Patient Access to Critical Breakthrough Products Act in 2018 during the 115th Congress.

Walorski represents the 2nd Congressional District of Indiana, serving as a member of the House Ways and Means Committee.

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Walorski, Kuster Lead Bipartisan Letter Calling on VA Clinicians to Check State Prescription Drug Monitoring Programs

Walorski, Kuster Lead Bipartisan Letter Calling on VA Clinicians to Check State Prescription Drug Monitoring Programs

WASHINGTON – U.S. Reps. Jackie Walorski (R-Ind.) and Annie Kuster (D-N.H.) today led a bipartisan group of 25 members of Congress in calling on the Department of Veterans Affairs (VA) to provide an update on their actions to ensure VA clinicians are complying with a law that aims to prevent overprescribing of opioids to veterans. The VA Prescription Data Accountability Act was  introduced by Kuster in 2017, co-sponsored by Walorski, and enacted with bipartisan support. The legislation requires VA clinicians to check prescription drug monitoring programs (PDMPs) for patients receiving opioid therapy.  A recent report from the Office of Inspector General (OIG) found that most VA clinicians are not adhering to the law and two-thirds of clinicians are unaware of the policy altogether.

“In light of the nationwide epidemic of prescription drug abuse, which has had a significant impact on veterans, we firmly believe that PDMP databases have proven effective and are valuable tools in tracking the coordination of prescriptions, preventing drug abuse and diversion, and reducing doctor shopping,” wrote the members. “We request an update on the actions VA is taking to carry out the recommendations outlined in the OIG report in order to ensure that VA clinicians are in full compliance with the law and providing the level of care our veterans deserve.”

PDMPs are statewide electronic databases that track controlled substance prescriptions. They can provide health authorities with up to date information about prescribing and patient behaviors that fuel the opioid epidemic and facilitate a smart, targeted response. Legislation introduced by Walorski, co-sponsored by Kuster, and passed into law in 2016 as part of the Comprehensive Addiction and Recovery Act requires VA to share information with state PDMPs in order to prevent overprescribing of opioids.

The full text of the letter is available here and below.

October 30, 2019

The Honorable Robert Wilkie
Secretary
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, D.C. 20420

Dear Secretary Wilkie,

As members of Congress who have been actively involved in crafting policy to prevent the overprescribing of opioids to veterans, we write with concern over a recent report (#18-02830-164) from the Office of Inspector General (OIG) that found most Department of Veterans Affairs (VA) clinicians are not adhering to requirements to check state prescription drug monitoring programs (PDMPs) for patients engaged with opioid therapy.

Specifically, the report found that from April 1, 2017, through March 31, 2018, VA clinicians failed to check PDMP databases for 567,000 of the 779,000 VA patients who are currently undergoing treatment with opioids.  It is estimated that 107,000 of the 567,000 patients for whom VA clinicians failed to make the required PDMP checks were at risk for opioid abuse or addiction due to poorly managed opioid treatment. Even more concerning, two-thirds of the 66 VA clinicians who were interviewed said they were unaware of the department policy regarding PDMPs, and only a quarter received training on PDMPs.

As you are aware, Veterans Administration Medical Centers (VAMCs) previously had the option to voluntarily report data to PDMPs, but were not mandated to do so as are all other doctors and pharmacists.  This created a glaring void in reporting that left veterans, already at an increased risk of abuse, even more vulnerable. In response to this situation, we worked together to enact legislation during the 114th Congress requiring the VA to report to state PDMPs.  In light of the nationwide epidemic of prescription drug abuse, which has had a significant impact on veterans, we firmly believe that PDMP databases have proven effective and are valuable tools in tracking the coordination of prescriptions, preventing drug abuse and diversion, and reducing doctor shopping.

We request an update on the actions VA is taking to carry out the recommendations outlined in the OIG report in order to ensure that VA clinicians are in full compliance with the law and providing the level of care our veterans deserve.  If you have any questions, your staff can contact Stephen Simonetti at stephen.simonetti@mail.house.gov or 202-225-3915, or Melanie Spears at melanie.spears@mail.house.gov or 202-225-5206.

We look forward to your response.

Sincerely,

Walorski represents the 2nd Congressional District of Indiana, serving as a member of the House Ways and Means Committee.

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