Skip to content
With the new administration bringing new leadership to the Centers for Medicare & Medicaid Services (CMS), one of the most significant healthcare decisions facing the agency will be the future of the Inflation Reduction Act (IRA) and changes to Medicare Part D.
It remains unclear how the new administration’s agenda may shape the program going forward. Nonetheless, these uncertainties have not stopped the Biotechnology Innovation Organization (BIO) from continuing its advocacy for IRA reforms that help patients.
BIO has long sought to recommend enhancements in Part D regulation and implementation to facilitate patients’ ability to access and afford their medicine, according to Crystal Kuntz BIO SVP, Health Policy & Research.
“We have concerns about how insurance plans will be tightening up the formulary of drugs they will cover—not just in terms of number of drugs covered, but also how a formulary is implemented,” Kuntz says. “For example, we take issue with how many hoops somebody has to jump through to get a drug, and we see other challenges to protecting patient access to medicine they need. That’s where a lot of our focus with CMS has been.”
While the IRA brought about important changes to make prescription drugs more affordable for seniors, including a cap on Medicare Part D beneficiary total out-of-pocket prescription drug costs at $2,000, other provisions have created unintentional negative consequences. One worry is that in response to increased financial liability, Medicare Part D plans could shift costs in a way that restricts patient access to prescription drugs.
“Patients face a growing risk that they will lose coverage of life-saving medications,” notes Melody Calkins, BIO Director, Healthcare Policy. “CMS needs to do more by listening to the patient community’s concerns and instituting guardrails to protect access.”
Removing barriers to Part D patient access
Part D plans and pharmacy benefit managers (PBMs) have significant flexibility in designing their drug coverage benefits and use utilization management (UM) tools to manage spending. In recent years, pressure from stakeholders led CMS to admit that inappropriate use of UM has become increasingly unsustainable, creating treatment delays and harming patient access to care, particularly in rural areas. With the new administration, BIO continues to urge CMS to more strictly oversee UM practices like:
- Step therapy, when patients are told they need to try cheaper alternatives to the drug their doctor prescribed. Patients may be asked to prove that several drugs “fail first” before they are allowed to get the doctor-recommended medication, and their health can suffer.
- Prior authorization, when an insurer or its PBM demand the right to approve a prescription before agreeing to cover it at the pharmacy, risking delays and the prescription of inferior drugs.
While there are general rules to ensure that health plans do not discriminate or discourage enrollment by beneficiary groups, current practices have not been sufficient to protect patients against UM. Additionally, there is limited publicly available information on plan formularies—the list of drugs that an insurer agrees to cover.
Call for more monitoring and reporting of Part D plans
Many of the industry’s concerns around Part D regulation involve the need for transparency into how CMS reviews health plans to ensure greater oversight of UM and stricter enforcement.
“It’s always been a black box, where CMS hasn’t been transparent in how they decide what health plans are deemed to be offering sufficient coverage,” says Calkins.
Over the longer term, BIO will work with incoming CMS leadership to recommend a number of Medicare Part D reforms around UM and coverage requirements to protect patients.
Improvements BIO calls for include establishment of an annual report on plan formularies that examines IRA trends and shows:
- What percentage of drugs in each category are subject UM for each insurer, as well as the type of UM (step therapy, prior authorization, or quantity limits).
- Percentages of Food and Drug Administration (FDA)-approved brand and generic/biosimilar drugs covered in each category, and percentages of drugs not covered.
- Comparative data on cost-sharing for each formulary tier, which is a grouping of drugs based on the amount copay/coinsurance for each drug.
BIO also calls for further reporting and monitoring of Part D exceptions and appeals. This information would give an indication of how often various insurers deny coverage for a drug and the reason for denial.
Improvements to help patients make payments
The Medicare Prescription Payment Plan (MPPP) is a new innovation that lets Part D beneficiaries spread the cost of medications over the course of a year, rather than having to deal with a large one-time payment.
The MPPP can be a big help to patients—as long as they know how to sign up and navigate the program. That’s why BIO urges CMS to improve accessibility and outreach so more patients can enroll. Simple fixes BIO recommend include facilitating navigation so the MPPP website is more accessible from the Medicare.gov homepage and the Medicare Plan Finder. Eventually, BIO hopes that the MPPP enrollment process is streamlined so that seniors can enroll in real time at the pharmacy counter and auto-enroll in future years.
When it comes to encouraging MPPP signup and navigating the challenges of choosing a Part D Plan, BIO has partnered with MapRX, a coalition of patient groups focused on Part D policy, and the National Health Council, a health policy coalition to which BIO belongs.
Working with these groups, and other organizations who advocate for patients, BIO is seeking to ensure that patients have access to the best care and treatments.
