Legislative & Regulatory Issues
Lead Federal Issues
Prescription Digital Therapeutics
Prescription digital therapeutics (PDTs) are evidence-based treatments that use software or virtual tools, and sometimes hardware, to deliver a clinical benefit to patients. These innovative products may identify, treat, or manage illnesses across a wide range of conditions, including post-traumatic stress disorder (PTSD), diabetes management, substance and opioid use disorders, attention-deficit hyperactivity disorder (ADHD), chronic back pain, and decreasing eyesight. PDTs are subject to review and authorization by the Food & Drug Administration (FDA) and must be prescribed by a health care provider. While private health payers and even certain public payers like the Veterans Health Administration already provide some beneficiaries access to PDTs, Medicare and Medicaid are prevented from covering PDTs because they do not fit into any of the statutorily-defined benefit categories for these programs.
AMCP supports the Access to Prescription Digital Therapeutics Act (S. 723/H.R. 1458), which would create a Medicare benefit category for PDTs and direct the Centers for Medicare and Medicaid Services (CMS) to establish appropriate payment methodologies for these treatments. The Access to PDT Act will help millions of Americans receive innovative care to treat a growing range of conditions and illnesses.
Value-based Care in Medicaid
Value-based payment arrangements are a critical tools for ensuring patient access to high-cost treatments, such as cell and gene therapies. Many high-cost drugs have highly variable outcomes between patients; what works for one patient may be ineffective for another. This makes value-based agreements, where compensation is tied to patient outcomes, more important than ever. Some therapies may only ever be available through value-based agreements. Unfortunately, value-based arrangements remain underutilized in Medicaid, limiting access for America's most vulnerable patients to the care they need.
AMCP supports the Medicaid VBPs for Patients (MVP) Act (H.R. 2666), which would incentivize greater use of value- based agreements by codifying the existing multiple best price rule for Medicaid and modernizing the way pharmaceutical manufacturers report pricing structure data to CMS. This important bipartisan legislation will expand access for vulnerable patients to high-cost, life-changing therapies that may only be available under value-based arrangements. The MVP Act further improves value-based purchasing agreements in Medicaid by expanding their use to inpatient drugs as well. This will allow patients to receive the care they need in whatever setting is most appropriate while protecting Medicaid from paying for treatments that do not have the expected outcomes for patients.
Learn more about value in Medicaid.
Reimbursement for Pharmacist-Provided COVID-19 Care
Pharmacists are the most accessible health care providers, with nearly 90% of Americans living within 5 miles of a pharmacy, and patients are increasingly relying upon pharmacists as their first point of care. This is especially true in rural areas where 77% of community pharmacies serve population areas of 50,000 or fewer, making pharmacists an essential care provider to medically underserved communities. Pharmacists played a key role in America’s response to the COVID-19 public health emergency by ordering and administering COVID-19 tests, treatments, and vaccines, as well as providing other services to prevent the spread of influenza, Respiratory Syncytial Virus, and strep throat. With the Biden administration’s announcement that the public health emergency will end on May 11, 2023, patients stand to lose access to vital care from their pharmacist.
AMCP supports the Equitable Community Access to Pharmacist Services Act (H.R. 1770), which would extend certain provisions put in place during the public health emergency that have been a critical lifeline for millions of patients. The bill would also establish coverage and reimbursement under Medicare Part B to enable and empower pharmacists to perform vital services in their communities for beneficiaries of these programs.
Learn more about pharmacy care.
Inflation Reduction Act Implementation
AMCP seeks to establish consensus between health care industry stakeholders and provide CMS with valuable insight from managed care practitioners to guide the agency’s implementation of the Inflation Reduction Act's (IRA) drug pricing provisions. The prescription drug pricing provisions of IRA significantly alter the Medicare program, including by requiring CMS to negotiate prices for certain single-source drugs with the highest cost to Medicare, requiring drug manufacturers to pay a rebate to CMS if a drug’s price increases faster than inflation, and redesigning the Part D prescription drug benefit. Several of the IRA’s most important provisions, including the Medicare Drug Price Negotiation Program, will not be fully implemented for several years. Certain provisions, such as out-of-pocket smoothing, will be challenging to implement. AMCP shares CMS’s commitment to improving seniors’ access to safe and cost-effective treatments.
Learn about the latest regulatory developments.
AMCP supports enhanced federal research funding to produce real-world evidence on biosimilar utilization to inform both care and public policy decisions. Biological products (biologics) are derived using cells and tissue from living organisms such as humans, animals, and microorganisms such as yeast or bacteria. Biologics have vastly improved the treatment of conditions such as rheumatoid arthritis, anemia, and various forms of cancer. Biologics are often extremely costly due to greater manufacturing complexity, higher research and development investment, and lack of competition. While biologics make up less than 5% of U.S. prescriptions by volume, they account for over 40% of net spending on prescription drugs. The high cost of biologics places financial stress on payers and prevents some patients from accessing crucial therapies. AMCP believes that speeding the adoption of biosimilars, which are certified by the FDA to be highly similar to a reference biologic, can help control drug spending through competition while providing patients the same high-quality treatments. According to one recent analysis, biosimilars adoption could save the health care system over $120 billion by 2025. One key barrier limiting the use of biosimilars is the lack of patient and provider education and misinformation about the relative safety of using biosimilar products.