4/13/23 - Opinion Editorial by Ken Thorpe, PFCD Chair in Real Clear Health 
Under the IRA, the Center for Medicare & Medicaid Services (CMS) is able to negotiate prices for dozens of drugs. When choosing which medicines to include in the program, and in determining the 'maximum fair price' for those medicines, CMS plans to consider a number of factors. One of these determinants is whether the drug meets an 'unmet medical need' for 'a condition for which treatment or diagnosis is not addressed adequately by available therapy.' However, there are no clear criteria for what constitutes an 'unmet medical need' in the bill. CMS's choice of how narrowly – or broadly – to define that term will heavily influence Medicare reimbursements, and thus impact biotech companies' investment decisions.

4/14/23 - Letter to CMS from National Organization for Rare Disorders (NORD) + 100 other healthcare organizations 
As part of the IRA, and for the first time, CMS will negotiate the price of some prescription drugs available through the Medicare program. This will have significant impacts for some rare disease patients on their ability to afford needed treatments but could also impact broader rare disease drug development… the vast majority of the more than 7,000 known rare diseases do not have an FDA approved treatment. This makes continued research and innovation especially important to the rare disease community. Unfortunately, the small patient populations and medical complexity associated with rare diseases creates unique challenges to rare disease drug development. These same factors result in a scarcity of the data necessary to determine a fair negotiated price for products that treat rare diseases.  While CMS’ most recent guidance includes several elements that positively impact the rare disease community, our organizations urge CMS to incorporate several changes into future guidance and program implementation to ensure the rare disease community fully benefits from the IRA. 

4/14/23 - Letter to CMS from the Partnership to Improve Patient Care (PIPC) + 55 oher healthcare organizations 
56 organizations representing patients and people with disabilities sent a letter to CMS related to its guidance for implementation of the Medicare Drug Negotiation Program. The letter to CMS provides the following recommendations and comments:

• We Urge Meaningful Engagement of Patients and People with Disabilities
• We urge CMS to Explicitly Recognize, Without Exception, the Existing Statute Barring Use of QALYs and Similar Measures
• Recommendations for Consideration of Non-QALY Evidence in Reports Using QALYs
• Recommendations for Consideration of Comparative Clinical Effectiveness Research and Appropriate Comparators
• Recommendations for Therapeutic Advance and Unmet Need
• We Urge CMS to Set a High Bar for the Quality of Evidence to be Considered.

The letter states, "For CMS to meet its obligations to beneficiaries, it will be critically important for CMS to be thoughtful in how it assesses therapeutic benefit to affected patients. CMS must ensure that patients and people with disabilities are granted a seat at the table and a clear and robust path to engagement throughout the process."

4/14/23 - Letter to CMS from the Partnership to Fight Chronic Disease (PFCD) + 23 other organizations
The Inflation Reduction Act (IRA) of 2022 involves sweeping changes to Medicare including the new Medicare Drug Price Negotiation Program. Given the wide-ranging implications for Medicare beneficiaries today and in the future and the vulnerability of the individuals affected, care to identify and avoid unintended consequences is paramount. These changes also do not occur in a vacuum but are made more complex by challenges with workforce shortages and other access issues that adversely affect many and risk worsening existing health disparities. We urge the Centers for Medicare & Medicaid Services (CMS) to remain vigilant and avoid unintended consequences given the significant changes implementation of the drug negotiation program represents. 

4/14/23 - Letter to CMS from National Health Council (NHC)
The NHC strongly upholds that decisions on value should be driven by the patient perspective. The best results occur when patient organizations can engage and when patients are not limited by policies that restrict access to products that best meet their individual needs. The NHC urges CMS to carefully consider these comments for this and future guidance and allow for patient voices to be heard and emphasized throughout the negotiation process.

4/14/23 - Letter to CMS from Patients Rising NOW 
While nothing in the Inflation Reduction Act requires a patient-centered approach, it is important that CMS understand that it is the patient that has the best understanding of what constitutes value when assessing a medicine. It is critical for seniors that CMS not follow the flawed model of organizations like the Institute for Clinical and Economic Review (ICER), which simulate cost-effectiveness from the payer's perspective. Patients frequently experience benefits from a therapy that are not captured by the health system. ICER’s generalized, unscientific, and assumption-based models do not capture patient experience with any individual treatment. Patient engagement should be at the core of the IRA implementation and any decision on drug pricing. Relying on a small cadre of health economists, academics, and bureaucrats will create a narrow perspective that is evident in the initial guidance memo from CMS. How CMS is considering drugs based on unmet medical need is far too limited and unsophisticated.  

4/14/23 - Letter to CMS from Alliance for Aging Research 
The Alliance has consistently urged federal policymakers to reject reliance on cost-effectiveness methodologies that discriminate against older adults and persons with a disability – the very populations that Medicare serves. As CMS implements the price negotiation provisions of the IRA, it is vital that the agency avoid the use of such methodologies and instead focus on use of patient-centered value assessment techniques.  Our concerns regarding implementation without due consideration of potential beneficiary impacts—including significantly decreased access to necessary drugs, therapeutics, and other forms of care—remain.

4/14/23 - Letter to CMS from Cancer Support Community 
We urge the agency to include additional measures to ensure the program is truly centered on the needs of patients and people with disabilities. Our recommendations below center on three pillars: 1) creating additional procedures to meaningfully engage with patients and ensure that the evidence CMS relies on is transparent; 2) establishing patient-centered standards and outcomes; and 3) more definitively rejecting the use of Quality-Adjusted Life Years (QALYs) and other discriminatory cost-effectiveness standards. We believe these recommendations will be useful to CMS in developing evidentiary standards and engagement practices that ensure patient benefits are central to decision making.
 

3/21/23 - Chronic Care Policy Alliance (CCPA) Letter to Congress: Ensure Patients Are Heard On IRA Implementation
In a letter to Congress and the Centers for Medicare & Medicaid Services (CMS), the Chronic Care Policy Alliance (CCPA) was joined by 35 organizations urging Congress and the Administration to ensure that patient advocates have a seat at the table throughout the implementation of the Inflation Reduction Act’s health policies. CCPA and its partners want to protect patient interests and avoid any unintended consequences by asking for patient input in the planning phase before implementation. Key messages from the letter include:
As patient representatives, we advocate on behalf of patient interests and interpret how certain policies will positively or negatively affect them. Patients know firsthand the benefits of a strong health care system that provides access to new and groundbreaking treatments. In recent years, we have seen great strides in the treatment of ALS, cancer and Alzheimer’s disease that have increased lifespan, slowed the ravage of disease and improved the quality of lives...The Medicare Drug Price Negotiation Program contained in the law seeks to establish negotiated rates, or the Maximum Fair Price (MFP), for medications. While focused on reducing drug costs, the unintended negative consequences for drug coverage, formulary priority, access and further research and development could harm patients. For example, as new prices are determined, payors may favor products on their formularies that have a negotiated price. This could ultimately make other medications more difficult to access as payors encourage use of these negotiated price medications and discourage others. Payors already utilize cost saving measures that negatively impact patients such as restrictive formularies, step therapy and strict prior authorizations. Patients need access to the correct treatments, or they will suffer. The addition of products with artificially lowered prices is likely to create yet another restrictive process for patients... It is critical that the Administration take patient needs and access to treatments into account when implementing the law. Our specific recommendations include:

• Host regional roundtables to solicit feedback from patients.
• Release draft guidance, solicit written comments. 
• Develop patient-centered criteria. 
• Meaningfully engage patients in determining the MFP for each drug. 
• Study the impact of the drug pricing provisions on patients

11/18/22 - Healthcare Leadership Council (HLC) Letter to HHS RE: Implementation of H.R. 5376, the “Inflation Reduction Act” 
Lowering the out-of-pocket costs consumers pay for prescription drugs and ensuring that consumers can manage those costs over the plan year is a priority for HLC members. Now that the IRA has passed into law, implementation of the law by the Department of Health and Human Services (HHS) must happen in a way that includes sufficient safeguards and provides clarity in the implementation process for all stakeholders, especially the patient. These include: 

• Engaging in meaningful stakeholder input.
• Utilizing the federal rulemaking process. 
• Collaborating with the private sector. 

 
10/6/22 - Applied Policy: THE IMPACT OF THE INFLATION REDUCTION ACT ON PHYSICIANS
The American Academy of Neurology (AAN), American College of Rheumatology (ACR), American Gastroenterological Association (AGA), and Association for Clinical Oncology (ASCO) maintain that the IRA does not consider the overhead costs associated with the acquisition and administration of drugs under the “buy-and-bill” models frequently employed by their members for drug administration. They estimate that, as a result, providers could expect a 41.5% decrease “in total payment, even accounting for reduction in acquisition costs.”