Bill Overview
Title: Access to Innovative Treatments Act of 2022
Description: 2022 This bill requires the Centers for Medicare & Medicaid Services (CMS) to review adverse national coverage determinations of drugs under Medicare within 30 days of receiving a request to do so. (Under the bill, adverse national coverage determinations are denials or limitations of coverage that are inconsistent with the drug's approval by the Food and Drug Administration.) The bill's requirements do not apply if the CMS already conducted such a review within a two-year period. The bill also prohibits the CMS from applying prior coverage determinations that were made for drugs before they were approved by the FDA if such determinations are inconsistent with the drug's approval.
Sponsors: Rep. Barragan, Nanette Diaz [D-CA-44]
Target Audience
Population: People dependent on Medicare and those needing innovative treatments
Estimated Size: 64000000
- The bill directly impacts individuals who are covered by Medicare, as it involves Medicare's coverage determinations.
- Medicare primarily serves people who are 65 years and older, as well as younger individuals with disabilities and certain conditions like end-stage renal disease.
- As of 2022, Medicare covers approximately 64 million people in the United States, including senior citizens and younger individuals with disabilities.
- Innovative drug treatments typically involve new, cutting-edge therapies that may not have existing coverage precedents under Medicare.
- The global pharmaceutical market is expected to reach $1.5 trillion by 2023, indicating a significant number of innovative drugs entering the market.
- This bill also impacts pharmaceutical companies, as it impacts how and when their products are covered by Medicare.
Reasoning
- The policy primarily affects individuals who rely on Medicare, particularly those who need access to costly and innovative medical treatments. Consequently, the population affected includes seniors and disabled individuals who are covered under Medicare.
- Since the policy targets coverage of innovative drugs, its effects would be more pronounced on people suffering from conditions that require cutting-edge medical treatments that are still awaiting CMS coverage decisions.
- Budgetary constraints imply that the policy may have to prioritize the most impactful cases or high-cost treatments that would benefit the maximum number of people under Medicare coverage.
- Not everyone within Medicare would require innovative treatments, so the policy likely impacts a subset of the population, focusing on those with complex health needs and conditions best treated with new medications.
- Within the broader policy and demographic context, people's personal circumstances (like health status, financial situation, and existing insurance coverage) and opinions about government healthcare decisions will shape their perception and reporting of wellbeing before and after policy intervention.
Simulated Interviews
Retired teacher (Florida)
Age: 75 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- I am hopeful that this new policy will make it easier for me to access the latest treatments.
- It's frustrating when treatments exist, but coverage issues make them inaccessible.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 4 |
Part-time consultant (California)
Age: 68 | Gender: male
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 10/20
Statement of Opinion:
- This policy could be a game-changer for me. Coverage uncertainty is a constant worry.
- It's important to have quicker decisions from Medicare, especially for expensive drug treatments.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 4 |
| Year 5 | 7 | 4 |
| Year 10 | 6 | 4 |
| Year 20 | 5 | 3 |
Retired nurse (New York)
Age: 80 | Gender: female
Wellbeing Before Policy: 3
Duration of Impact: 3.0 years
Commonness: 7/20
Statement of Opinion:
- I think it's great that they're trying to streamline the process.
- Access to innovative treatment is difficult, and every bit helps.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 3 |
| Year 2 | 6 | 3 |
| Year 3 | 5 | 2 |
| Year 5 | 4 | 2 |
| Year 10 | 4 | 1 |
| Year 20 | 3 | 1 |
Retired engineer (Texas)
Age: 72 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 0.0 years
Commonness: 12/20
Statement of Opinion:
- While the policy might not impact me directly, if it leads to better mental health benefits, I will support it.
- I am relatively okay with my current medications.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 5 |
Retired librarian (Illinois)
Age: 90 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 0.0 years
Commonness: 15/20
Statement of Opinion:
- I don't think this policy affects me much, but I support changes that could help others.
- The healthcare system is complicated, and any improvement is welcome.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 7 | 7 |
| Year 10 | 6 | 6 |
| Year 20 | 5 | 5 |
Disabled veteran (Ohio)
Age: 55 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 5.0 years
Commonness: 7/20
Statement of Opinion:
- I hope this speeds up access to better treatments through Medicare.
- Dealing with the VA and Medicare is already a lot; anything that improves efficiency is welcome.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 6 | 5 |
| Year 5 | 7 | 5 |
| Year 10 | 7 | 5 |
| Year 20 | 6 | 4 |
Retired social worker (North Carolina)
Age: 65 | Gender: female
Wellbeing Before Policy: 4
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- I welcome anything that makes approval for new treatments faster.
- My quality of life depends on access to a range of treatments.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 6 | 4 |
| Year 3 | 7 | 4 |
| Year 5 | 8 | 4 |
| Year 10 | 7 | 4 |
| Year 20 | 5 | 3 |
Retired factory worker (Michigan)
Age: 70 | Gender: other
Wellbeing Before Policy: 4
Duration of Impact: 3.0 years
Commonness: 9/20
Statement of Opinion:
- I am skeptical but hopeful that this policy can make some real changes.
- Usually, red tape delays treatment options.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 5 | 4 |
| Year 2 | 5 | 4 |
| Year 3 | 6 | 4 |
| Year 5 | 6 | 4 |
| Year 10 | 5 | 4 |
| Year 20 | 4 | 3 |
Retired farmer (Georgia)
Age: 85 | Gender: female
Wellbeing Before Policy: 3
Duration of Impact: 1.0 years
Commonness: 10/20
Statement of Opinion:
- Policies like this seem good on paper, but in rural areas, we rarely see the benefits.
- Access is my biggest issue.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 4 | 3 |
| Year 2 | 4 | 3 |
| Year 3 | 5 | 3 |
| Year 5 | 5 | 3 |
| Year 10 | 4 | 3 |
| Year 20 | 4 | 2 |
Retired government employee (Washington)
Age: 77 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 2.0 years
Commonness: 11/20
Statement of Opinion:
- If this helps with future treatments, I'm all for it.
- Currently, I'm okay, but I want the reassurance for the future.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 7 | 6 |
| Year 10 | 6 | 5 |
| Year 20 | 6 | 5 |
Cost Estimates
Year 1: $50000000 (Low: $30000000, High: $70000000)
Year 2: $50000000 (Low: $30000000, High: $70000000)
Year 3: $50000000 (Low: $30000000, High: $70000000)
Year 5: $50000000 (Low: $30000000, High: $70000000)
Year 10: $50000000 (Low: $30000000, High: $70000000)
Year 100: $50000000 (Low: $30000000, High: $70000000)
Key Considerations
- The capacity of CMS to effectively manage and process reimbursement determinations under tighter timelines.
- The possibility of CMS requiring additional staffing or contracting for expertise to review complex innovative treatments.
- Impact of the bill on encouraging faster market introduction of new and potentially cost-saving innovative treatments.