House Passes Insulin Bill

The U.S. House of Representatives has passed the Affordable Insulin Now Act seen here. According to the bill’s summary this bill does the following: 

• Limits cost-sharing for insulin under private health insurance and the Medicare prescription drug benefit.

• Caps cost-sharing under private health insurance for a month's supply of selected insulin products at $35 or 25% of a plan's negotiated price (after any price concessions), whichever is less, beginning in 2023.

• Caps cost-sharing under the Medicare prescription drug benefit for a month's supply of covered insulin products at $35 beginning in 2023.

• Currently, the Centers for Medicare & Medicaid Services is testing a voluntary model under the Medicare prescription drug benefit (the Part D Senior Savings Model) in which the copayment for a month's supply of insulin is capped at $35 through participating plans. The model is set to expire on December 31, 2025.

• The bill also (1) further delays implementation of regulations relating to the treatment of certain Medicare prescription drug benefit rebates from drug manufacturers for purposes of federal anti-kickback laws, and (2) increases funding for the Medicare Improvement Fund.

The bill now goes to the Senate where 60 votes are needed to send it to the President. 

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our healthcare practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.   

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What to Know about CURES 2.0

In November 2021, U.S. Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) today introduced their bipartisan Cures 2.0 legislation. The bill which is aimed at helping patients of innovative companies within healthcare and life sciences can be viewed here.

According to Congressman Upton’s press release the bill:

• Creates an entirely new agency aimed at ending some of the world’s most difficult diseases – such as cancer, diabetes, ALS, Alzheimer’s and more. The so-called Advanced Research Projects Agency for Health, or ARPA-H, would be housed within the National Institutes of Health and tasked with finding new cures and treatments to a slate of illnesses that affect tens of millions of Americans across the country. 

• Transform how Medicare covers innovative new treatments and technologies to make those new discoveries available to patients sooner.

• Increase access to telehealth services for Medicare and Medicaid patients, including those covered under the Children’s Health Insurance Program, known as CHIP, to ensure more Americans are getting the help they need, when they need it. 

• Provide training and educational programs for at-home caregivers – including family members with no prior health care experience to help them better care for loved ones when they are home.

• Require more diversity in clinical trials to ensure any new drugs and treatments approved for use in the U.S. are both safe and effective for a greater – and more representative – portion of the population.

• Provide patients more information about the illness they face and the treatment options available to them to make them a more integral part of the decision-making process.

We have featured this bill in a previous November 23, 2021 blog post. We believe that this is a great opportunity if you are a manufacturer, telehealth provider or clinical trial stakeholder. CURES 2.0 is something that we have been forceasting since 2020 as a way to make our system better. 

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our life sciences practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

Prescription Digital Therapeutics (PDTs) Legislation Introduced

The Access to Prescription Digital Therapeutics Act of 2022 has been introduced by  Reps. Mike Thompson (D-CA) and David McKinley (R-WV) and Sens. Jeanne Shaheen (D-NH) and Shelly Moore Capito (R-WV). 

“According to the bill’s release, it would expand Medicare coverage to include PDTs, which are software-based treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the U.S. Food and Drug Administration (FDA), and prescribed by health care providers. PDTs are designed and tested much like traditional prescription drugs but rather than swallowing a pill or taking an injection, patients receive cognitive therapy through software.” 

The bill sponsors released a one page fact sheet about the bill and PDTs itself.

“Prescription Digital Therapeutics (PDTs) are software-based disease treatments designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the FDA, and prescribed by healthcare providers. These therapies are designed and tested much like traditional prescription drugs with one distinction: rather than swallowing a pill or taking an injection, patients are treated with software.

The COVID-19 pandemic and public health emergency rapidly accelerated the pace of innovation to address some of the most pressing challenges in health care. New tools are being rapidly deployed and adopted, particularly in the case of digital health, which are increasingly being used, PDTs provide clinicians and patients with evidence-based remote treatment modalities to treat substance and opioid use disorders, mental health, diabetes and other diseases and conditions. However, there is no clear statutory benefit category to allow for Medicare and Medicaid coverage for PDTs.”

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our HealthIT practice can help stakeholders understand what’s at issue with topics like digital therapeutics, RTM and RPM so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.

CURES 2.0 Biomedical Legislation Introduced Into Congress

U.S. Reps. Diana DeGette (D-CO) and Fred Upton (R-MI) are back as they recently introduced their long anticipated and bipartisan Cures 2.0 legislation. The bill is discussed via Congresswoman DeGette’s press release.  

So what does this proposed legislation do:

• Transform how Medicare covers innovative new treatments and technologies to make those new discoveries available to patients sooner.

• Increase access to telehealth services for Medicare and Medicaid patients, including those covered under the Children’s Health Insurance Program, known as CHIP, to ensure more Americans are getting the help they need, when they need it. 

• Provide training and educational programs for at-home caregivers – including family members with no prior health care experience to help them better care for loved ones when they are home.

• Require more diversity in clinical trials to ensure any new drugs and treatments approved for use in the U.S. are both safe and effective for a greater – and more representative – portion of the population.

• Provide patients more information about the illness they face and the treatment options available to them to make them a more integral part of the decision-making process.

• Conduct a nationwide study on the implications of long COVID; and 

• Develop a nationwide testing and vaccine distribution strategy to be used in future pandemics. 

The proposed bill can be viewed here while a section by section summary can be viewed here.   

Lanton Law is a national healthcare and life science boutique law and government affairs firm that closely monitors legislative, regulatory and legal developments for our clients. Our life sciences practice can help stakeholders understand what’s at issue so that we can help our valued clients reach their goals. Contact us to learn about how either our legal or lobbying services can help you attain your goals.