Questions for Mehmet Oz, M.D. for his nomination to lead CMS
1. Copay Assistance for Prescription Drugs: Due to high out-of-pocket costs, many patients rely on manufacturer assistance to afford their prescription drugs. In fact, in 2023 drug companies provided $23 billion in copay assistance to help consumers pay for their medications. Unfortunately, approximately half of all commercial health insurers along with their PBMs are not applying that copay assistance to the beneficiary’s out-of-pocket maximum and are collecting double what they should be, saddling consumers with added costs for their drugs. A federal judge in 2023 struck down the rule that allows insurers to carry out these harmful practices.1 However, CMS is ignoring the ruling and has failed to enforce it.
a) Will you comply with the court’s judgment and require insurance companies to apply copay assistance to a patient’s annual maximum out-of-pocket limit?
2. Preventive Services & PrEP: Each new HIV diagnosis has a lifetime treatment cost of more than $500,000. In 2023, the S. Preventive Services Task Force issued an updated Grade A recommendation for pre-exposure prophylaxis (PrEP) to include new long-acting PrEP formulations. CMS has directed insurers to cover all PrEP drugs and services without cost-sharing, including long-acting injectables. Despite this requirement, studies show that up to a third of commercially insured people are still being charged co-pays for their PrEP.2
a) Will the Trump administration continue to uphold the ACA preventive services requirements in order to help make America healthy again?
b) Will you commit to taking enforcement actions against insurers illegally implementing cost-sharing for preventive services?
c) Will you ensure that as new long-acting PrEP drugs are approved by the FDA, insurers will cover them without cost-sharing?
3. Private Insurance Prescription Drug Coverage & Affordability: Ending HIV, hepatitis, and other illnesses cannot happen without a comprehensive healthcare system that includes robust private insurance, Medicaid and Medicare programs, upholding non- discrimination protections, and combating stigma and disparities. The nondiscrimination patient protections in the Affordable Care Act ensure that insurers cannot design plans that place all or the majority of drugs for a certain condition in a high-cost tier and that they cover drugs included in widely accepted treatment guidelines.
a) Will you commit to robust enforcement of the ACA laws and regulations that protect patients with chronic diseases like HIV from discriminatory benefit designs related to formulary tiering and coverage?
4. Medicare Part D Six Protected Classes: Antiretrovirals for the treatment of HIV are one of Medicare’s six protected classes, and beneficiaries therefore have access to the full range of all effective medications in these classes of special significance. The serious health conditions treated by medications in the six protected classes, which also include people with mental health challenges, epilepsy, Parkinson’s disease, lupus, cancer, and those requiring organ transplants, require complex treatments by drugs that are not readily interchangeable.
a) Will you commit to supporting Medicare patients in the six protected classes and oppose policies that would limit drug coverage in the six protected classes?
b) Do you commit to maintaining the prohibition on prior authorization for antiretrovirals in Medicare?
1 https://hivhep.org/wp-content/uploads/2023/09/HIV-Hepatitis-Policy-Institute-v.-HHS-DDC-opinion.pdf
2 See https://www.croiconference.org/wp-content/uploads/sites/2/posters/2024/1117.pdf for ancillary services; for drug cost-sharing, see Slide 11, https://hivhep.org/wp-content/uploads/2024/05/Key-PrEP- Policy-Issues-Impacting-Access-for-InsuredPopulations-5.29.24.pdf. From Zachry et al., Impact of the United States Preventive Task Force Guidelines on Pre-Exposure Prophylaxis (PrEP) Claims and HIV-1 Infection Incidence: An Interrupted Time Series with Segmented Regression Analysis. AMCP-Nexus 2023, Orlando FL.