Updates in Federal Legislation Addressing Digital Therapeutics, Access to Care

Health care legislation has been on hold at the federal level following Kevin McCarthy’s (R-CA) removal as Speaker of the House. Although legislation cannot currently pass through Congress, important actions around digital therapeutics, access to care, and health and care disparities, are still important to highlight.

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In a session at the Academy of Managed Care Pharmacy’s (AMCP) Nexus 2023 conference, Jennifer Mathieu, MA, senior vice president of Professional and Government Affairs at AMCP, and Geni Tunstall, JD, director of Regulatory Affairs at AMCP, discussed federal legislative and regulatory updates that are on the horizon.

“The really positive news is most of us are only looking at the next 3 months, but we do have a whole other calendar year where we can for pursue various health care legislation,” Mathieu said in the presentation. “We are not going to have to reintroduce because we're not starting a new Congress at the beginning of 2024, so we don't have to reintroduce any of these bills and continue to work on them in 2024 if we are unsuccessful in getting them signed into law this year.”

Mathieu started by discussing legislation regarding digital therapeutics and technology, including the Access to Prescribing Digital Therapeutics Act, which was initially introduced in 2022 and reintroduced in March 2023. The bill is designed to provide benefits for prescribing digital therapeutics (PDTs) in Medicare and Medicaid—including coverage and reimbursement—and would be limited to digital therapeutics that are cleared or authorized by the FDA and prescribed by a health care provider.

The legislation would not require coverage by the Centers for Medicare and Medicaid Services (CMS) for specific PDTs and would use the normal formulary decision processes for digital therapeutics. Currently, CMS does not have authority under the law to cover PDTs, as Medicare and Medicaid do not have the flexibility to cover these products outside of the defined benefits categories.

In addition to the legislation, the FDA will be putting together a Digital Health Advisory Committee to advise on digital health technologies. The FDA will be accepting nominees until December 11, 2023. This committee will include 9 core members who will advise the FDA commissioner on all digital health technology developments, including artificial intelligence, machine learning, wearable devises, and digital therapeutics, according to Mathieu.

High-cost therapies are also a focus of current legislation, including the Medicaid Value-Based Purchasing (VBP) for Patients (MVP) Act. This piece of legislation will enhance Medicaid access to new and high-cost therapies for patients, which would include cell and gene therapies. The intent is to modernize the framework for VBP arrangements in Medicaid, clarifying the best price under VBP arrangements for the maximum possible price paid, Mathieu said.

Further, if passed, the Equitable Community Access for Pharmacist Services Act will authorize pharmacists to receive reimbursements under Part B for COVID-19 care, including testing, vaccination, and treatment provided at the end of the public health emergency, according to Mathieu. It will expand upon future public health emergency issues under the PREP Act during COVID-19 and will also cover influenza and RSV. This will hopefully improve access to care in underserved communities, Mathieu said.

Another hot topic includes biosimilars. With more biosimilars coming to the forefront of care, the Biosimilar Research Fund and National Biosimilars Project Act will include appropriations for either the National Institutes of Health or other agencies of similar caliber, to help fund large population and epidemiology research on biosimilars, which will help to further define interchangeability. This will allow biosimilar-to-biosimilar interchangeability or substitution under pharmacy entities, Mathieu said.

Pharmacy benefit manger (PBM) reform has been one of the most noteworthy topics in pharmacy for 2023. Some current legislation includes the Pharmacy Benefit Manger Transparency Act, Modernizing PBMs and Ensuring Accountability Act, Pharmacy Benefit Manger Reform Act, PATIENT Act, Transparency in Coverage Act, and Health Care Price Transparency Act. In a separate session at AMCP Nexus 2023, Melissa Andel, MPP, principal of CommonHealth Solutions LLC, explored PBM reforms and important legislation on the horizon.

Mathieu included an AMCP prediction that the year-end health care package will include language related to drug access, PBMs, insulin caps in the commercial market, and product hopping. Other important legislation that could potentially pass includes the Pandemic and All Hazard Preparedness Act, and the Substance Use Disorder Prevention that Promotes Opioid Recovery Treatment for Patients and Communities Act. She added there is proposed legislation that targets drug shortages, which is another challenge that still needs to be addressed.

Tunstall also provided regulatory updates around the Inflation Reduction Act (IRA). The major prescription drug provisions would include Medicare drug pricing negotiation, Part D reforms, and inflationary rebates. CMS has also released a variety of rules and guidance over the past year and will continue to release more throughout the implementation of new requirements.

For drug price negotiations, CMS will meet with the various manufacturers of 10 medications, who will have 3o days to either accept the CMS offer or present a counteroffer to the agency. CMS will also host patient-focused listening sessions, which will include insight from patients, caregivers, beneficiaries, and patient advocacy groups, as part of the drug negotiation process. The sessions will be held between October 30 and November 15, 2023, and will be open to the public and live streamed.

The 10 drugs include apixaban (Eliquis; Bristol Myer Squibb, Pfizer); sacubitril/valsartan (Entresto; Novartis); insulin aspart (Fiasp, NovoLog; Novo Nordisk); sitagliptin (Januvia; Merck); ustekinumab (Stelara; Janssen Immunology); etanercept (Enbrel; Amgen); dapagliflozin (Farxiga; AstraZeneca); ibrutinib (Imbruvica; Pharmacyclis, Janssen); empaglifozin (Jardiance; Boehringer Ingelheim); and rivaroxaban (Xarelto; Janssen).

Some key dates for the IRA:

• January 1, 2024: The start date of the catastrophic phase of Medicare and the premium stabilization.
• July 1, 2024: The cap on Part B payment for new biosimilars.
• September 1, 2024: The maximum fair price for the first 10 drugs published from CMS that are listed above.
• January 1, 2025: Medicare Prescription Payment Plan and a $2000 out-of-pocket limit.
• September 30, 2025: Part B inflation rebates start.
• January 1, 2026: The maximum fair price will go into effect.

Reference

Mathuieu J, Tunstall G. Federal Legislative and Regulatory Update. AMCP Nexus 2023. Orlando, Florida. October 17, 2023. Accessed October 17, 2023.