Medicare Drug Price Negotiations Again Target High-Impact Prescriptions, But at what Cost?

By: Marcus J. Hopkins, Health Policy Lead Consultant, ADAP Advocacy

The Trump Administration recently released the next round of medications selected for the Medicare Drug Price Negotiation Program, which includes 15 medications payable under Medicare Part B and/or covered under Medicare Part D, largely for the treatment of chronic diseases and cancer.

Photo Source: CMS

Of greatest concern to ADAP Advocacy is the inclusion of Biktarvy, the most commonly prescribed single-pill oral regimen to treat HIV made by Gilead Sciences, currently taken by over 430,000 people living with HIV in the United States (Gilead Sciences, 2026), or 35.8% of People Living With HIV/AIDS (PLWHA).

In June 2025, ADAP Advocacy submitted public comment to the Centers for Medicare and Medicaid Services (CMS). In this public comment, it requested that CMS create a carve-out exemption for all medications used for the treatment of HIV/AIDS in order to avoid any interruptions of service for PLWHA who rely upon Medicare for their HIV medications.

ADAP Advocacy followed up on this public comment with a sign-on letter to CMS requesting the carve-out exemption, which garnered signatures from nearly 40 organizations and received a direct response from Dr. Mehmet Oz, the current CMS Administrator.

The response?

"CMS acknowledges your recommendation to implement a carve-out exemption for all medications indicated for the treatment and prevention of HIV/AIDS; however, the statute does not specify a specific exclusion for medications used for the treatment of HIV/AIDS from selection under the Negotiation Program."

Essentially, “Sorry. Can’t help you.”

Photo Source: ADAP Advocacy

What Does Price Negotiation Mean?

As ADAP Advocacy detailed in a July 2025 blog, Medicare’s Negotiation Program essentially requires manufacturers to accept the final price after four negotiation meetings set by CMS, reject the offer, and pay a 95% excise tax on all of the medications sold to Medicare payors, or remove their products from the Medicare formularies altogether (Hammond, 2024). Because no business can feasibly accept a 95% excise tax and remain viable, manufacturers are left with the unenviable decision to either accept significant profit losses in the Medicare market or withdraw their drugs (Hopkins, 2025). This process, which is supposed to resemble a negotiation, has been characterized by many as a threat with the full force of the federal government behind it. One public health stakeholder attending ADAP Advocacy’s Health Fireside Chat last year in Minneapolis, Minnesota, called it extortion. 

For PLWHA, the inclusion of one of the most effective single-pill regimens in the history of HIV treatment on this list presents a real and present danger should Gilead Sciences determine that allowing Biktarvy to be purchased at a significant loss by Medicare payors is unacceptable.

Medicare is the 2nd-largest payor of HIV treatment and care in the United States, accounting for 39% of federal spending in 2020, and serving 28% of PLWHA (Dawson, et al., 2023).

Patient advocates continue to share their concerns over Biktarvy, or any other HIV-related product, being targeted by CMS for artificial government price controls. Among them is Aging and HIV Institute’s David “Jax” Kelly, JD, MPH, MBA. Kelly argued, “Nearly 28% of PLWH in the United States are Medicare beneficiaries, and most qualified through disability rather than age… [t]his unique cost profile reflects both the effectiveness and the financial burden of HIV treatment. Interruptions in ART jeopardize not only individual health but also public health goals. Sustained viral suppression—essential to ending the epidemic—depends on reliable, affordable access to medications.”

ADAP Advocacy will follow up with its aforementioned communications with CMS by submitting public comments in response to its request for information about selected drugs and their therapeutic alternatives, because the inclusion of an antiretroviral therapeutic “is playing with fire,” as ADAP Advocacy’s CEO has noted on numerous occasions.

Photo Source: Andreas Marquardt/Shutterstock

What Can Patients Do?

Please find information below on how you can get involved:

[From CMS]:

The Negotiation Program enables Medicare to directly negotiate the prices of certain high-cost drugs. The current cycle of negotiation and renegotiation is underway, and CMS wants to hear directly from patients, caregivers, clinicians, and others to gather input relevant to the selected drugs.

CMS invites you to rally the communities you represent to share information about the public engagement events, including a virtual livestreamed town hall meeting focused on the clinical considerations related to the selected drugs, and private (i.e., not livestreamed or open to press or general public) virtual patient-focused roundtable events, one for each selected drug, for patients, patient advocacy organizations, and caregivers.  

Take Action

• Learn more about the drugs selected for the current cycle of negotiation and renegotiation here.
• Use communication tools available here so that your organization can leverage your various communication channels to share information about these opportunities:
• Complete the Drug Price Negotiation Information Collection Request (ICR).
• Register for public engagement events here. 

Key Dates

• The Drug Price Negotiation ICR is now available, and responses are due by March 1, 2026. It is worth noting that for patients wanting to submit public comments, questions 28-33 are the patient- or caregiver-focused input (so don’t get overwhelmed by the length of the online form)
• Drugs selected for the upcoming cycle of negotiation and renegotiation were announced on January 27, 2026, and registration for the public engagement events is open now until March 6, 2026.
• Public engagement events for Biktarvy include:
• Roundtable event on Monday, April 6 from 2:30 – 4:30 p.m. ET 
• Town Hall Meeting on Wednesday, April 22, Session 1 from 10:30 a.m. – 12 p.m. ET

Photo Source: Portland.gov 

Registration for the opportunity to speak at the public engagement events is now open and will close at 11:59 p.m. PT on March 6, 2026.

• To register for a roundtable event, click here. 
• To register for the town hall meeting, click here. 

Reach out to IRARebateandNegotiation@cms.hhs.gov with any questions, using the subject line “Public Engagement.”

ADAP Advocacy urges patients and patient advocates to weigh in. While financial outlays may be high for PLWHA due to treatment costs, the financial impacts of treatment interruption are far higher. While treatment cessation for any disease state can cause serious complications, the nature of the HIV retrovirus is such that it can quickly mutate to develop resistance to a treatment regimen if that regimen is suddenly halted. This can create a strain of HIV that is multidrug-resistant (MDR-HIV), making the virus more difficult and significantly costlier to treat–and result in premature death. CMS targeting an HIV-related therapeutic signals a threat to AIDS exceptionalism, and it cannot be left to chance.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

References:

[1] Centers for Medicare and Medicaid Services. (2026, January). Medicare Drug Price Negotiation Program: Selected Drugs for Initial Price Applicability Year 2028. Washington, DS: United States Department of Health and Human Services: Centers for Medicare and Medicaid Services. https://www.cms.gov/files/document/factsheet-medicare-negotiation-selected-drug-list-ipay-2028.pdf

[2] Dawson, L., Kates, J., Roberts, T., Cubanski, J., Neuman, T., & Damico, A. (2023, May 27). Medicare and People with HIV. KFF: HIV/AIDS. https://www.kff.org/hivaids/issue-brief/medicare-and-people-with-hiv/

[3] Gilead Sciences. (2026). Biktarvy. Foster City, CA: Gilead Sciences: Biktarvy: About Biktarvy. https://www.biktarvy.com/about-biktarvy

[4] Hammon, J. (2024, August 19). Price controls – bad policy, big problems. Washington, DC: Paragon Health Institute. https://paragoninstitute.org/paragon-prognosis/price-controls-bad-policy-big-problems/

[5] Hopkins, M. J. (2025, July 10). CALL TO ACTION: HIV Medication Carve-Out Exemption from the Medicare Drug Price Negotiation Program. Nags Head, NC: ADAP Advocacy: ADAP Blog. https://adapadvocacyassociation.blogspot.com/2025/07/call-to-action-hiv-medication-carve-out.html

A HIV Drug Medicare Carveout Exemption is NOT All About the Profits

By: Marcus J. Hopkins, ADAP 340B Consultant

In July 2025, ADAP Advocacy submitted public comment to the Centers for Medicare and Medicaid Services (CMS) regarding the proposed guidance for the Medicare Drug Price Negotiation Program (“Negotiation Program”) established under the Inflation Reduction Act (2022), requesting a carveout exemption from forced price negotiations for medications used for the treatment of HIV.

Photo Source: ADAP Advocacy

After submitting this public comment, we took the opportunity to reach out to other HIV organizations, including the Aging and HIV Institute (A&H)’s David “Jax” Kelly, JD, MPH, MBA.

Kelly raised several key points that he believes would better center our arguments around patient access, medication affordability, and the elimination of barriers to accessing medications. These points, he told us, would help to reframe our argument to make it more patient-centered and less about pharmaceutical company participation in the Medicare market and profitability.

He was, in part, correct.

ADAP Advocacy is, at its heart, a patient-centered organization. From the beginning, our organization has prioritized patient access to HIV care, treatment, and supportive services. Our initial focus dealt with eliminating the waitlists that prevented patients in dire need of HIV treatment services from enrolling in state AIDS Drug Assistance Programs (ADAPs). Every aspect of our work has been patient-centered, and we have endeavored to frame every project, initiative, research effort, report, and infographic in a manner that prioritizes what is best for patients.

Our submission to CMS attempted to frame pharmaceutical company participation as a broader issue that could prevent patients from accessing their life-saving medications. We contend our framing achieved that objective, but nonetheless, we're open to alternative interpretations. After all, one of our organization's value statements reads, "That the voice of persons living with HIV/AIDS shall always be at the table and the center of the discussion."

With that in mind, ADAP Advocacy asked Kelly for his thoughts on the carveout. In his response, Kelly provided the following insights:

[The following comments were composed by David “Jax” Kelly, JD, MPH, MBA]

David "Jax" Kelly, JD, MPH, MBA

_____________________________________________

Medicare and HIV: A Lifeline for Long-Term Survivors

Nearly 28% of PLWH in the United States are Medicare beneficiaries, and most qualified through disability rather than age (Figueroa et al., 2024; Dawson, 2023). For this population, Medicare Part D is a lifeline, yet HIV medications account for a disproportionate share of program spending. In 2020, prescription drugs made up 63% of Medicare spending for PLWH compared to just 4% for other beneficiaries (Dawson, 2023).

This unique cost profile reflects both the effectiveness and the financial burden of HIV treatment. Interruptions in ART jeopardize not only individual health but also public health goals. Sustained viral suppression—essential to ending the epidemic—depends on reliable, affordable access to medications.

Moreover, a majority (61%) of Medicare beneficiaries with HIV are dually eligible for Medicaid, highlighting their financial and medical vulnerability (Dawson, 2023). These dual-eligible beneficiaries face some of the most complex systemic barriers and are at greatest risk if policy shifts raise out-of-pocket burdens.

Patient Affordability and Financial Burden

Even when medications are technically “covered,” high co-pays and cost-sharing can prevent patients from filling prescriptions. Research shows persistent gaps in ART adherence among Medicare beneficiaries with HIV, often tied to affordability barriers (Li et al., 2023).

The Inflation Reduction Act reshaped Medicare Part D plan designs, and analyses show that some changes may actually increase cost burdens for patients depending on their plan type (Cai et al., 2025; Doshi et al., 2025).

Consider a hypothetical example:

For a retired Medicare beneficiary living on $1,400 a month, an additional $100 in monthly drug costs could force a choice between filling an HIV prescription and paying for groceries or rent. For long-term survivors already managing multiple chronic conditions, even modest increases in out-of-pocket (OOP) costs can destabilize adherence and jeopardize viral suppression.

Drug coverage protections exist—ART is already a “protected class” under Part D—but these safeguards do not directly limit cost-sharing. Without a carveout, federal savings from negotiation could inadvertently be achieved at the expense of patient affordability and adherence.

Equity and Systemic Barriers

Medicare beneficiaries with HIV are disproportionately people of color, LGBTQ+ individuals, and long-term survivors. According to KFF, most (77%) qualified for Medicare through disability rather than age, and a majority (61%) are dually eligible for Medicaid (KFF, 2025). These data underscore the extent of financial and medical vulnerability within this population—reflecting the compounding effects of poverty, disability, and structural inequities.

The burden of prescription drug costs falls especially hard on people with HIV. While prescription drugs account for just 4% of Medicare spending among other beneficiaries, they represent 63% of Medicare spending for people with HIV (Dawson, 2023). This disproportionate reliance on costly medications makes beneficiaries uniquely exposed to policy changes that could shift costs onto patients.

Photo Source: HealthHIV

The most recent State of Aging with HIV Report adds further context. Nearly 80% of older adults living with HIV delayed or avoided care due to insurance or out-of-pocket costs, and almost half struggled to pay for housing, food, or utilities (HealthHIV, 2025). Insurance restrictions such as step therapy and prior authorizations are increasingly blocking or delaying access to needed HIV medications. At the same time, many report fragmented care: over one-third rely on emergency departments for non-urgent needs, while 63% lack access to case management services (HealthHIV, 2025).

These inequities extend beyond finances. Nearly half of older adults with HIV report feeling lonely or isolated, and more than three-quarters experience moderate to high levels of mental health stress (HealthHIV, 2025). Meanwhile, providers highlight systemic barriers as well: 59% cite shortages of clinicians trained in both HIV and geriatrics as the most pressing obstacle to appropriate care.

Equity in drug policy is not just a matter of fairness; it is central to survival. The National HIV/AIDS Strategy emphasizes reducing disparities in HIV outcomes for racial and ethnic minorities, LGBTQ+ communities, and older adults. If CMS drug price negotiations inadvertently increase barriers to HIV treatment, they risk undermining these national goals at a time when they are already under political attack.

Protecting affordability and uninterrupted access through a carveout would ensure that Medicare policy advances—rather than reverses—the nation’s commitment to equity in HIV care and outcomes.

_____________________________________________

Kelly’s comments offer additional clarity and justification in favor of a carveout exemption in a way that focuses less on the continued participation of pharmaceutical companies and more on the real-world needs of patients who rely upon the Medicare program.

One of the primary reasons we work with collaborative partners and organizations is to ensure that the work we’re doing is focused on meeting the needs of patients. ADAP Advocacy specifically works with other organizations and policy shops to inform, refine, and bring clarity to the positions we release.

We are incredibly grateful to Jax Kelly for helping us to fulfill that mission.

References:

Cai, C. L., Bhaskar, A., Kesselheim, A. S., & Rome, B. N. (2025). Changes in Medicare Part D plan designs after the Inflation Reduction Act. JAMA Internal Medicine. Advance online publication. https://doi.org/10.1001/jamainternmed.2025.4003

Dawson, L., Kates, J., Roberts, T., Cubanski, J., Neuman, T., & Damico, A. (2023). Medicare and people with HIV. San Francisco, CA: KFF. https://www.kff.org/hivaids/report/medicare-and-people-with-hiv/

Dickson, S., & Hernandez, I. (2023). Drugs likely subject to Medicare negotiation, 2026–2028. Journal of Managed Care & Specialty Pharmacy, 29(7), 732–739. https://doi.org/10.18553/jmcp.2023.29.3.229

Doshi, J. A., Li, P., Harrison, J., Romley, J., & McWilliams, J. M. (2025). Inflation Reduction Act provisions and Medicare Part D out-of-pocket costs for specialty drugs. JAMA Health Forum, 6(8), e233849. https://doi.org/10.1001/jamahealthforum.2025.1387

Figueroa, J. F., et al. (2024). Antiretroviral therapy use and disparities among Medicare beneficiaries with HIV. Journal of General Internal Medicine, 39(12), 3456–3464. https://doi.org/10.1007/s11606-024-08847-y

Figueroa, J. F., et al. (2025). Use of nonrecommended antivirals among Medicare beneficiaries with HIV. JAMA Network Open, 8(7), e2312345. https://doi.org/10.1001/jamanetworkopen.2025.8296

HealthHIV. (2025). The fourth state of aging with HIV national survey report. Washington, DC: HealthHIV. https://healthhiv.org/wp-content/uploads/2025/01/Fourth-HealthHIV-State-of-Aging-with-HIV-Report.pdf

Kakani, P., Kyle, M. A., Chandra, A., & Maini, L. (2024). Medicare Part D protected-class policy is associated with lower drug rebates. Health Affairs, 43(8), 1290–1298. https://doi.org/10.1377/hlthaff.2024.00273

Li, P., et al. (2023). Antiretroviral treatment gaps and adherence among people with HIV in Medicare. Journal of Acquired Immune Deficiency Syndromes, 92(2), 145–152. https://doi.org/10.1007/s10461-023-04208-8

Patterson, J. A., et al. (2024). Medicare Part D coverage of drugs selected for the Drug Price Negotiation Program. JAMA Health Forum, 5(2), e234562. https://doi.org/10.1001/jamahealthforum.2023.5237

Sadeghi, A., & Varisco, T. J. (2025). Medicare Drug Price Negotiation Under The Inflation Reduction Act: Ensuring the Continuity of Critical Real-world Pharmaceutical Studies. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, S1098-3015(25)02466-0. https://doi.org/10.1016/j.jval.2024.12.012

White, E. N., Saxon, M., Hodge, J. G., Jr, & Michaels, J. (2023). Medicare Drug Pricing Negotiations: Assessing Constitutional Structural Limits. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 51(4), 956–960. https://doi.org/10.1017/jme.2024.12 

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.     

CALL TO ACTION: HIV Medication Carve-Out Exemption from the Medicare Drug Price Negotiation Program

By: Marcus J. Hopkins, ADAP 340B Consultant

ADAP Advocacy has submitted public comments to the Centers for Medicare and Medicaid Services (CMS) regarding the proposed guidance for the Medicare Drug Price Negotiation Program (“Negotiation Program”) established under the Inflation Reduction Act (2022):

While ADAP Advocacy’s objections to the Negotiation Program’s proposed implementation are several, our primary request is for the creation of a carve-out exemption for all medications used for the treatment of HIV/AIDS in the U.S. that would prevent these treatments from being eligible for any future Medicare price negotiations.

Photo Source: CMS

ADAP Advocacy has requested this carve-out exemption due to the serious nature of the threat facing People Living with HIV/AIDS (PLWHA), should HIV medications be selected as part of the Negotiation Program. While the HIV treatment landscape has improved significantly over the last 25 years, today only a handful of manufacturers continue to work in the HIV space, including Gilead Sciences, ViiV Healthcare, and Merck. Over the past decade, three manufacturers—Bristol Myers Squibb, AbbVie, and Johnson & Johnson—have withdrawn from the HIV space for various reasons, not least of which is the difficulty of competing in a landscape where many of the most significant innovations, including well tolerated single-pill regimens, long-acting injectable agents, and highly effective oral and injectable prophylaxis, have already occurred.

As part of this effort, ADAP Advocacy has also spearheaded a national sign-on letter seeking support from national, state, and local advocacy organizations. The letter and the signature form are available online at: https://www.adapadvocacy.org/letter-cms-hiv-carveout.php. 

The Negotiation Program essentially requires manufacturers to accept the final price after four negotiation meetings set by CMS, reject the offer, and pay a 95% excise tax on all of the medications sold to Medicare payors, or remove their products from the Medicare formularies altogether (Hammond, 2024). Because no business can feasibly accept a 95% excise tax and remain viable, manufacturers are left with the unenviable decision to either accept significant profit losses in the Medicare market or withdraw their drugs.

Photo Source: Inside Sources

The prospect of losing access to HIV medications paid for through Medicare poses a significant risk to PLWHA. Medicare is the 2nd-largest payor of HIV treatment and care in the United States, accounting for 39% of federal spending in 2020, and serving 28% of PLWHA (Dawson, et al., 2023). Additionally, 77% of PLWHA who are enrolled in Medicare first qualified for the program not because of age but because of a disability diagnosis.

Patients who lose access to HIV medications may fall out of treatment entirely, placing them at risk of dying from opportunistic infections or having their HIV mutate to develop resistance to the medications used to achieve viral suppression—when the number of actively replicating HIV cells drops below 200 copies per milliliter of blood. In addition to these primary risks, patients whose HIV is not virally suppressed, or undetectable, can pass along the virus to others. In contrast, those whose viral load is undetectable are unable to do so.

In addition to the carve-out for HIV medications, ADAP Advocacy made the following recommendations:

1. CMS should implement a standardized Market Fair Price calculation methodology that replaces the methodology outlined in section 60.3 that is clear, transparent, and made available to manufacturers at the time the Market Fair Price is determined and when the initial offer is made to manufacturers;
2. CMS should revise its definition of “selected drug” as set forth in section 30.1 to ensure limit the inclusion of multiple formulations and strengths of medications to ensure that price determinations and negotiations are made in good faith;
3. CMS should undertake an immediate patient engagement campaign prior to the implementation of the proposed guidance for the Negotiation Program to ensure that Medicare beneficiaries have a clear understanding of how the Program will directly impact them and to allow patients to provide meaningful feedback and opinions to help guide the program to better patient-centered outcomes; and
4. CMS should exclude any cost-effectiveness calculations that utilize biased and discriminatory metrics, including Quality-Adjusted Life Years and similar measures of medical intervention efficacy.

A precedent already exists for protecting vulnerable populations from the unintended consequences of changes to the healthcare ecosystem, as evidenced by Medicare’s six protected classes (6PC). In Medicare Part D, 6PC protects vulnerable seniors and low-income beneficiaries with severe and complex health conditions, while also allowing Part D insurance plans to utilize the necessary tools to control costs. Medicines for some of the sickest patients in Part D are covered within the six protected classes, including those for cancer, epilepsy, HIV/AIDS and mental illness. Many of these conditions require patients to attempt a variety of therapies before they and their doctor settle on the most appropriate treatment, so there is no one-size fits all medicine for these conditions (Johnson, 2019).

Photo Source: VAROS

Healthcare decisions for complex health conditions should be left to patients, and their doctors. For people living with HIV/AIDS, numerous factors come into play when determining the appropriate highly active anti-retroviral therapy (HAART). And now with the advent of injectable HIV therapy, such decisions take-on an entirely new dimension."

These recommendations represent the bare minimum of changes that should be made to the Negotiation Program. ADAP Advocacy asks advocacy organizations to add their names to the circulating sign-on letter, as it continues to work with legislative and administrative officials to ensure that patient voices are heard and their access to life-saving treatments is sustained.

[1] Dawson, L., Kates, J., Roberts, T., Cubanski, J., Neuman, T., & Damico, A. (2023, May 27). Medicare and People with HIV. KFF: HIV/AIDS. https://www.kff.org/hivaids/issue-brief/medicare-and-people-with-hiv/

[2] Hammon, J. (2024, August 19). Price controls – bad policy, big problems. Washington, DC: Paragon Health Institute. https://paragoninstitute.org/paragon-prognosis/price-controls-bad-policy-big-problems/

[3] Inflation Reduction Act of 2022, Pub. L. No. 117-169, 136 Stat. 1818 (2022). https://www.congress.gov/117/plaws/publ169/PLAW-117publ169.pdf

[4] Johnson, Juliet (2019, January 31). New Research Shows Changes to the Six Protected Classes Would Harm Most Vulnerable Patients and Are Unnecessary. ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2019/01/new-research-shows-changes-to-six.html 

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.     

Trump's Executive Order on Drug Prices Includes Both Good and Bad Ideas

By: Ranier Simons, ADAP Blog Guest Contributor

On April 15, 2025, President Donald J. Trump signed Executive Order 14273: Lowering Drug Prices by Once Again Putting Americans First (Exec. Order No. 14273, 2025). The executive order is meant to delineate actions the Administration will take as solutions to lower prescription drug prices for Americans. The executive order’s actions include changes to the Medicare Drug Price Negotiation Program, drug importation, and addressing the activity of Pharmaceutical Benefit Managers (PBMs). The various provisions of the order are to be enacted on staggered timetables of 60, 180, and 365 days from the issuance of the order. The specificity of the various provisions varies. Yet, it is prudent to examine the major themes.

Photo Source: AP Photo/Alex Brandon

The most detailed section of the executive order is Section Three: Improving upon the Inflation Reduction Act (Exec. Order No. 14273, 2025). This section addresses the Administration's perceived flaws in the Medicare Prescription Drug Negotiation Program (MPDNP). The President describes the MPDNP as too complex and expensive, feels it caused changes to the Medicare Part D program that were detrimental to seniors, and distorts innovation by creating a “pill penalty” between large and small molecule drugs.

The “pill penalty” concerns the period allowed before a small-molecule or large-molecule drug is eligible for price negotiation. The MDPNP law identifies high-cost prescription drugs, whether brand name or biological, without generic or biosimilar equivalents, as eligible for negotiation (Cubanski & Neuman, 2025). This effectively means that small-molecule drugs would be affected by Medicare negotiated prices 9 years following their FDA approval, in contrast to 13 years for biologics. Small-molecule drugs are synthetic drugs that are chemically synthesized, while biologics are extracted from living organisms. Small-molecule drugs are typically administered in pill form or non-sterile liquid (Pantheon, 2025). Most biologics are available in injectable or intravenously administered forms, have special requirements to maintain stability, and are more complex and much more expensive to produce than small-molecule drugs (Caris, 2025).

Photo Source: YouTube / Seniors 4 Better Care

The executive order aims to increase small-molecule drug eligibility for price control to match that of the biologic drugs. The sentiment is that the discrepancy is a disincentive for investment in developing lower-cost small-molecule drugs, which are cheaper and used by a larger population than biologics (Exec. Order No. 14273, 2025). Biologics are typically used to treat things such as rare diseases or cancer. The possible outcome is that Medicare spending could increase. If this change were applied to the drugs that have already been selected in the first and second rounds of Medicare negotiations, half of the chosen medications, which equate to total gross Medicare Part D spending of $61 billion out of $91 billion, would not have qualified (Cubanski & Neuman, 2025). Some stakeholders are concerned that the change would result in higher prices and premiums for Medicare Part D recipients. The executive order mentions that other actions would be taken to prevent adverse price increases without specificity.

Section Eight: Reevaluating the Role of Middlemen hints at addressing issues surrounding PBMs (Exec. Order No. 14273, 2025). The order instructs a multi-department investigation to create recommendations “…on how best to promote a more competitive, efficient, transparent, and resilient pharmaceutical value chain that delivers lower drug prices”. The White House fact sheet released in tandem with the executive order also explains that the order will address the influence of middlemen and promote open competition (White House, 2025). While PBM reform initiatives are occurring in multiple states, recent actions of the Administration do not support the expressed desire for PBM reform. 

The Federal Trade Commission (FTC) is actively involved in a lawsuit against the three largest PBMs concerning their activities that allowed them to take in millions in profits at the expense of patients regarding high-priced insulin drugs. The FTC has also released a second report highlighting how PBMs have grossly marked up and manipulated generic drugs. Yet, the President fired two FTC commissioners in March (Godoy, 2025). This resulted in the FTC’s general counsel issuing an administrative stay in the case since there are no Commissioners available to adjudicate the case. 

Photo Source: AIS Health

Additionally, newly released draft legislation created by the House Judiciary Committee, in essence, removes federal antitrust enforcement powers from the FTC and consolidates them under the DOJ (Fuchs & McCarthy, 2025). The DOJ prosecutes the law, while the FTC, as an administrative body, has functions such as writing rules, enforcing laws, and conducting market studies. The Administration's actions favor its desire to bring about deregulation, which is not in alignment with PBM reform. The theme of deregulation is evidenced in the carefully worded verbiage of Section Two of the executive order, which states, “It is the policy of the United States that Federal health care programs, intellectual property protections, and safety regulations are optimized to provide access to prescription drugs at lower costs to American patients and taxpayers” (Exec. Order No. 14273, 2025).

Another notable section of the executive order is Section Ten: Increasing Prescription Drug Importation to Lower Prices (Exec. Order No. 14273, 2025). This section, in part, states it “shall take steps to streamline and improve the Importation Program under section 804 of the Federal Food, Drug, and Cosmetic Act to make it easier for States to obtain approval without sacrificing safety or quality.” A breadth of data indicates that drug importation as a means to lower prescription drug costs is not a viable tool. 

The nature of the drug supply and the drug supply chain indicate that there is not enough of a drug supply to acquire medications from a country like Canada, which is frequently referenced as a source for cheaper medications. Most importantly, drug importation lends itself to infiltration by bad actors that can introduce counterfeit, improperly handled, and low-efficacy drugs into the supply chain. Dangerous counterfeit drugs already exist in the U.S. drug supply. Bulk importation is a flawed idea since it would source medications from other countries outside the U.S. safe drug tracking system, which are not subject to our strict regulations and oversight. Moreover, Canada has explicitly stated, "Health Canada does not assure that products being sold to U.S. citizens are safe, effective, and of high quality, and does not intend to do so in the future” (Partnership for Safe Medicines, 2022). Florida, the only state with an FDA-approved drug importation plan, has already spent $50 million on a warehouse and over $24 million on an importer (Galewitz, 2024). It has not imported any drugs or saved any money.

The aforementioned sections are just a few of the fourteen sections listed in the executive order. Those sections describe more direct actions, indicating actionable changes. The other sections can be characterized as promises to investigate concerns, with the desired output being reports explaining the solution. Indeed, the high price of drugs is a problem worthy of intervention. However, the implementation of much of the order is unclear, as are the end products of what it nebulously implies. Time will indicate if the executive order results in benefits, falls short with no effect, or worse yet, creates more problems.

[1] Caris Life Sciences. (2025). Difference Between Small Molecule and Large Molecule Drugs. Retrieved from https://www.carislifesciences.com/difference-between-small-molecule-and-large-molecule-drugs/  

[2] Cubanski, J, Neuman, T. (2025, April 16). The Effect of Delaying the Selection of Small Molecule Drugs for Medicare Drug Price Negotiation. Retrieved from https://www.kff.org/policy-watch/the-effect-of-delaying-the-selection-of-small-molecule-drugs-for-medicare-drug-price-negotiation/

[3] Exec. Order No. 14273, F.R. 90 (2025, April 15). Lowering Drug Prices by Once Again Putting Americans First. Retrieved from https://www.federalregister.gov/documents/2025/04/18/2025-06837/lowering-drug-prices-by-once-again-putting-americans-first

[4] Fuchs, H., McCarthy, M. (2025, April 29). Trump could gain vast new deregulatory and antitrust powers under GOP megabill plans. Retrieved from https://www.politico.com/news/2025/04/29/trump-executive-powers-reins-act-ftc-antitrust-00317105

[5] Galewitz, P. (2024, November 20). Florida Gov. DeSantis' Canadian drug import plan goes nowhere after FDA approval. Retrieved from https://www.cbsnews.com/news/florida-desantis-fda-canadian-drug-imports/

[6] Godoy, J. (2025, March 19). Trump fires both Democratic commissioners at FTC. Retrieved from https://www.reuters.com/world/us/trump-fires-both-democratic-commissioners-ftc-sources-say-2025-03-18/

[7] The Partnership for Safe Medicines. (2022). Drug importation endangers U.S. patients. Retrieved from https://www.safemedicines.org/importation-page

[8] The White House. (2025, April 15). Fact Sheet: President Donald J. Trump Announces Actions to Lower Prescription Drug Prices. Retrieved from https://www.whitehouse.gov/fact-sheets/2025/04/fact-sheet-president-donald-j-trump-announces-actions-to-lower-prescription-drug-prices/

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

HIV Advocates Worry About the Unintended Consequences of the Inflation Reduction Act

By: Marcus J. Hopkins, Executive Director, Appalachian Learning Initiative

Advocates across the HIV patient, provider, and pharmaceutical sectors are sounding the alarm about the potential for provisions within the Inflation Reduction Act of 2022 to have unintended consequences for people living with HIV/AIDS (PLWHA). Specifically, advocates, including ADAP Advocacy, are concerned that Sections 11001 and 11002—the sections that establish the Medicare Drug Price Negotiation Program that will give the Centers for Medicare and Medicaid Services (CMS) the ability to negotiate maximum fair prices (MFPs) for certain high expenditure, single source drugs and biologic products—will stifle innovation, limit the selection of antiretroviral (ARV) medications for PLWHA, and create new barriers for PLWHA attempting to access medications to treat other conditions as PLWHA continue to age while living with the disease.

Photo Rights Purchased via iStock

Aside from restricting access to medications, there are other concerns. One of the primary arguments being made is that the setting of MFPs for ARV medications may inadvertently have a negative impact on AIDS Drug Assistance Program (ADAP) revenues generated by the 340B Drug Pricing Program.

For the uninitiated, 340B is a federal pricing program that requires pharmaceutical companies to sell drugs to covered entities—including ADAPs—at the lowest possible price. Pharmacies then sell those drugs to outpatients and receive rebates for the difference between the drug’s list price and the lowest possible price. The rebates are considered “revenues,” and are used to sustain operations by many AIDS Service Organizations’ and HIV clinics. (Editor's Note: Learn more about the 340B Program)

When MFPs are set, these rebates may, depending upon the medications in questions, leave pharmacies purchasing drugs at significantly lower “best prices” or even “penny prices,” where the total 340B discounts are greater than the MFP set for the drug and pharmacies are required to purchase the drugs for $0.01. This means that the rebate amount for those drugs would actually end up costing the pharmacy money to sell the medications, thus disincentivizing them from carrying the drugs, at all (Newton, 2024).

Right now, the MFPs would only apply to drugs covered by the Medicare program, and it is unknown how or if MFPs would have any direct impacts on ADAPs. However, as PLWHA continue to live relatively healthy lives into their later years, they will become eligible for Medicare. Once ADAP recipients become eligible for Medicare, they must enroll in Medicare Part D, and ADAPs can help clients with Part D plan-related co-pays, deductibles, and premiums.

A secondary concern related to MFPs is that placing price controls (in this case, MFPs) will disincentivize drugmakers from continuing to innovate (i.e., develop new treatments, potential vaccines, and potential cures) by limiting the profits they can make from their products. There is evidence to suggest it is already happening.

Section 11001 also instituted Prescription Drug Inflation Rebates, a mechanism by which drug manufacturers are required to issue rebates to CMS for brand name drugs without generic equivalents that cost $100 or more per year per patient and for which those manufacturers increase the prices of those drugs faster than the rate of inflation. Section 11002 goes further, requiring manufacturers that fail to comply with civil penalties (i.e., financial fines).

The issue with attempting to convince consumers that these provisions of the IRA will have negative impacts on the pharmaceutical market—and thus for patients—is that these provisions are broadly popular across the political spectrum. A majority of consumers have consistently been in favor of multiple approaches to lowering drug prices, with the Kaiser Family Foundation finding that 88% of respondents supporting the institution of price increase caps and 88% being in favor of forcing drug manufacturers to negotiate drug prices with the government for Medicare (Figure 1). In fact, majorities of patients across the political spectrum have reported being in favor of expanding these provisions beyond Medicare (Figure 2).

Figure 1 - Before the Inflation Reduction Act, There Was Broad Support to Many Approaches to Lowering Drug Costs

Photo Source: KFF

(Source: Sparks, Kirzinger, Montero, Valdes, & Hamel, 2024)

Figure 2 - Majorities of Voters Across Partisanship Support Proposals to Expand IRA Provisions Beyond Those With Medicare

Photo Source: KFF

(Source: Sparks, Kirzinger, Montero, Valdes, & Hamel, 2024)

Drug manufacturers and other experts across the healthcare industry, however, have consistently argued that the financial impacts of these types of measures are not conducive to continuing their investments in research and development for new drugs, and will force them to reevaluate their expenditures in continuing to innovate and bring new drugs to the market, as well as force them to make tough choices about which medications to continue making (Chen, 2024).

Part of what makes these arguments difficult to explain is the significant opacity as it relates to exactly how manufacturers determine the list prices of their medications in the United States and what percentage of that list price is actually paid by providers, insurers, and patients.

In general, American consumers are broadly unaware of how the United States healthcare system actually works. From the consumer perspective, the only concerns they tend to take into account are if and when they can see their doctors, whether or not the medications prescribed to them will work, and whether or not they can afford the costs of healthcare services and their prescription drugs. While this may seem like simple concerns, each of these steps along the way is fraught with multiple complex cost considerations behind the scenes.

From determining which physicians are “in-network” vs. “out-of-network,” to which services are covered, to whether or not a drug is included on a formulary, and what the out-of-pocket costs are to patients, every step includes complex price negotiations between public and private insurers, the providers, and drug manufacturers to which patients are both unaware and unallowed to evaluate due to trade secrets laws that protect how list prices and negotiated prices are determined.

Moreover, insurers, pharmacy benefit managers (PBMs), and manufacturers are not forthcoming with how these prices are established. This leaves both consumers and legislators to attempt to figure out these issues without being provided with a full picture of the greater healthcare ecosystem.

The MFPs and penalties for price increases above inflation, while popular with consumers and many legislators, may ultimately end up making the costs associated with developing, testing, branding, getting approval for, marketing to consumers, and selling prescription medications so cost prohibitive that manufacturers will simply decide to slow down the pace of innovation or to exit the market entirely.

An example of this can be directly seen in the decision by Novo Nordisk to discontinue Levemir (insulin detemir) in the United States. Levemir is basal insulin product that is widely used by some patients with Type 2 diabetes and Type 1 patients who are teens, athletes, or pregnant due to its short-lasting effects and the ability of patients to adjust their dosages to meet their insulin needs (Chen, 2024).

The IRA specifically set out-of-pocket price caps on insulin at $35 for patient on Medicare. While Novo Nordisk initially indicated that they would cut the prices of their insulin products by 75% for NovoLog and 65% for Novolin and Levemir (Silverman, 2023), the decision to discontinue this product for American consumers has left patients scrambling to find scrambling to find either new medications to treat their diabetes or new sources for Levemir, which may drive them to attempt to purchase the drug from other countries, and thus open them to the risk of counterfeit medications that could potentially kill them.

Additionally, this decision has exposed a key gap between the intention of these provisions and the reality of a relatively open market for drug manufacturers: even if officials can force manufacturers to lower their prices, those companies can simply pull the drugs off the markets without guaranteeing that other manufacturers will continue to make the compound (Chen, 2024).

This, again, goes back to why transparency in pricing and price negotiations is such a vital piece of information for both consumers and legislators. Without access to these details, pushes to make drugs more affordable to patients come up against the financial realities that drive the for-profit healthcare industry, as for-profit drug manufacturers are essentially the only entities developing, testing, and bringing medications to market.

Finally, one of the key arguments being made by advocates and drug manufacturers is that the voices of the patients who are impacted by healthcare laws and policies need to be more regularly and publicly included during the crafting of legislation and administrative rules.

Over the past forty years, patients and other consumers have become increasingly vocal about the healthcare services we receive, particularly in chronic disease spaces, like HIV. It is hard to argue the impacts that early HIV/AIDS groups, such as ACT UP New York, have had on several facets of the drug development and healthcare delivery arenas. Their very public, disruptive, and vocal protests and demonstrations during the 1980s and 90s forced the the U.S. Food & Drug Administration to shorten wait times during the development of key HIV medications during the early day of the epidemic (Neus, 2023).

While this type of patient activism has largely fallen out of favor, these actions paved the way for legislators and government agencies to establish patient and community advisory bodies. As part of the creation of those bodies, the processes through which patients could have a direct say in the decisions that impact them were formalized, and heavy emphases have been placed on civility and “right time; right place” expectations that have left many advocates hesitant to participate in formalized settings with which they’re unfamiliar and for which the rules of engagement are both unspoken and unclear.

Essentially, the fire and ire tactics used in the 1980s and 90s no longer fly in the 2020s, as politicians and administrative officials simply refuse to tolerate them. That isn't to say protests don't happen, because they do but their effectiveness is hard to measure. This means that public comment periods and other opportunities for patients to speak to these officials have become increasingly inaccessible over time, often requiring significant financial and time investments from those patients to attend oddly scheduled and poorly advertised in-person sessions, as well as submit written public comments through labyrinthine pathways that are made purposely difficult to navigate.

What ended up replacing those early protests were patient advocacy groups run by people who are more familiar with these processes and rules, and who work very diligently to craft specific messaging that, in their experiences, are more likely to move officials to go in directions that they believe most beneficial to patients. This has resulted in fewer realistic opportunities for patients to engage with the people who are making decisions that directly impact their lives.

Beyond those advocacy groups, drug and device manufacturers make significant financial investments in patient-level advocacy efforts. These efforts are almost always not specific to any one medication, instead focusing on specific disease states (e.g., HIV/AIDS, breast cancer, and other chronic conditions) where patients are both dependent upon the medications used to treat those conditions and have the most to lose if they lose access to them.

Investments in patient advocacy groups, such as ADAP Advocacy, are often used to craft educational campaigns designed to make patients aware of disease statistics and policies that may impact patient access to life-saving medications. Industry groups representing hospitals, PBMs, and insurers often use these investments as “evidence” to discount patient perspectives, both implying and directly stating that any advocacy efforts funded, either in part or in whole, by drug manufacturers cannot be trusted because they are being influenced by those manufacturers. It amounts to nothing more than a cheap shot, designed to further dismiss the patient perspective. (Editor's Note: Read ADAP Advocacy's transparency statement)

Photo Rights Purchased via iStock

As with every aspect of healthcare in the United States, including patients can be tricky. As tensions between political parties in this country have become more fraught over the past two decades, legislators in particular are more likely to treat public testimonies during hearings not as opportunities to hear from patients, but to cross examine “witnesses.” Example of this can be seen at all levels of government, particularly when the legislation being discussed relates to the provision of healthcare services that certain segments of the population have turned into “moral” issues (e.g., the sale of contraception, the provision of abortion services, and the dispensing of Pre-Exposure Prophylaxis [PrEP] to prevent the transmission of HIV). During these hearings, some legislators will use their time to not just ask questions of the patients and medical experts giving testimony, but to call into question their experiences and expertise, accuse them of being “funded” by nefarious sources (e.g., “You’re being funded by George Soros!”), and make openly defamatory and bigoted statements about the patients who need access to medications and services, such as contraceptives, in-vitro fertilization, abortions, and PrEP, making statements that imply that the fact that they need those services and medications is a moral failing on their part.

This adversarial atmosphere has convinced many patients that their voices are neither welcomed nor actually considered when laws and rules are made that directly impact their lives. This makes including the patient voice all the more vital to ensure that laws like the IRA are crafted with all of the stakeholders in mind and that careful consideration is given to the potential downstream consequences.

The inclusion of patient voices is invaluable. It affords elected officials and policy-makers to consider perspectives they may not otherwise think to includes; to take into account the real-world impacts of their policies that they may not see because those officials often have the best healthcare coverage tax dollars can buy, while patients—particularly those living with chronic conditions—are often just scraping by to survive.

The long-term impacts of the IRA can, just two years after its passage, only be predicted. While some short-term impacts are being felt, we don’t actually have good data to definitively state that certain outcomes will come to pass. We can only make our best guesses given the information we have at hand and the environments in which we work. We will continue to monitor the impacts of the IRA as the years progress, as well as any other developments that will directly impact patients.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Still Protected! Medicare's Six Protected Drug Classes Policy Survives Trump's Attack

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

In the waning days of the Trump Administration, Medicare Part D once again faced a serious threat. The Centers for Medicare & Medicaid Services (CMS) had authorized a potentially harmful demonstration project, which would have limited patient access to medications covered by the six protected classes (6PC) policy. The 6PC demonstration project would have proved disastrous for patients living with chronic health conditions, such as HIV/AIDS. Fortunately, President Joseph R. Biden Jr. pumped the brakes on the proposed changes.

Photo Source: The Associate Press

In Medicare Part D, 6PC protects vulnerable seniors and low-income beneficiaries with serious and complex health conditions, while also allowing Part D insurance plans to use the tools they need to control costs. Medicines for some of the sickest patients in Part D are covered within the six protected classes, including those for cancer, epilepsy, HIV/AIDS and mental illness.  Many of these conditions require patients to attempt a variety of therapies before they and their doctor settle on the most appropriate treatment, so there is no one-size fits all medicine for these conditions.[1]

Healthcare decisions for complex health conditions should be left to patients, and their doctors. For people living with HIV/AIDS, numerous factors come into play when determining the appropriate highly active anti-retroviral therapy (HAART). And now with the advent of injectable HIV therapy, such decisions take-on an entirely new dimension.  

Earlier this year, HealthHIV's Executive Director Brian Hujdich spelled out the importance of the Medicare Part D's 6PC for the HIV-positive community: "Those medications are protected for good cause. About 25 percent of people living with HIV in the United States depend on Medicare for their antiretrovirals, care, and preventative services. These patients often require very tailored treatment regimens."[2]

The insurance industry welcomed the proposed changes, but otherwise the 6PC demonstration project was universally condemned by the pharmaceutical industry, patient advocacy groups, and numerous powerful trade associations. Said Guy Anthony: “I’m deeply concerned as someone living with HIV and Bi-polar disorder. Insurers would be allowed to institute new prior authorization or step therapy requirements – or ‘fail first’ – as community advocates commonly call it. Let’s be clear, no patient should fail before being afforded life-saving treatment.”

The latest 6PC demonstration project wasn't the first time that the Trump Administration had attempted to weaken Medicare Part D. In the end, however, patients won the day! There is an inherent value in advocacy partnerships...AGAIN!

Photo Source: Partnership for Part D Access

The effort to fight the proposed changes to Medicare’s six protected classes policy was spearheaded by the Partnership for Part D Access, which is a broad coalition of healthcare stakeholders working to ensure that Medicare continues to provide beneficiaries with access to vital medications. The ADAP Advocacy Association actively fought against the proposed changes.

“Medicare beneficiaries with the most complex, chronic conditions are breathing a sigh of relief,” said Chuck Ingoglia, President and CEO of the National Council for Behavioral Health, who serves as Executive Director of the Partnership for Part D Access. “The Biden administration’s decision demonstrates the need to maintain the six protected classes policy as an essential patient safeguard in Medicare Part D.”[3]

According to the Partnership for Part D Access,[4] it was stakeholder mobilization against the 6PC demonstration project that led to it being halted by the Biden Administration. Advocacy efforts included:

• 67 bipartisan Members of Congress signed a letter to HHS and CMS urging them to withdraw the proposal;
• several thousand patients from across the country wrote letters to the CMS comment portal;
• over 130 individual patient groups joined a letter to HHS Secretary-designate Xavier Becerra;
• nine leading pharmacy stakeholder groups penned a letter to the Acting CMMI Director Amy Bassano;
• the Center for Medicare Advocacy and Medicare Rights Center sent a letter to Acting HHS Secretary Norris Cochrane; and
• a group of 30 leading HIV groups sent a letter to HHS Secretary-designate Becerra.

Although the Biden Administration is widely viewed more favorably by the patient advocacy community, now is not the time for the HIV community to let down its guard. Much more work needs to be done to reverse other harmful policies enacted by the Trump Administration, such as drug importation and co-pay accumulator programs.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

[1] Johnson, Juliet (2019, January 31). New Research Shows Changes to the Six Protected Classes Would Harm Most Vulnerable Patients and Are Unnecessary. ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2019/01/new-research-shows-changes-to-six.html.

[2] Hujdich, Brian (2021, February 26). President Biden must rescind a last-minute Trump rule that could leave people with HIV on the hook for thousands in prescription costs. HIV Plus Magazine. Retrieved online at https://www.hivplusmag.com/opinion/2021/2/26/trumps-parting-shot-hiv-patients.

[3] The Partnership for Part D Access (2021, March 16). Patient Advocates Applaud Biden Administration for Maintaining Medicare's Six Protected Classes Policy. Retrieved online at http://www.partdpartnership.org/newsroom/patient-advocates-applaud-biden-administration-for-maintaining-medicares-six-protected-classes-policy.

[4] The Partnership for Part D Access (2021, March 16). Patient Advocates Applaud Biden Administration for Maintaining Medicare's Six Protected Classes Policy. Retrieved online at http://www.partdpartnership.org/newsroom/patient-advocates-applaud-biden-administration-for-maintaining-medicares-six-protected-classes-policy.

Together, We Can Lower Out-of-Pocket Costs & Increase Access to Healthcare

By: Amy Niles, Executive Vice President, PAN Foundation 

Your voice as a patient advocate, and the voices of the patients you support, are critically important when it comes to health policy. You have experiences to share, perspectives to provide and valuable input on proposed policy solutions. Healthcare policy is only effective if it addresses patient needs and improves access to and affordability of treatment. 

That is why the PAN Foundation has launched its online advocacy action center – to provide a central place for information about effective ways to communicate with elected officials, and importantly, to be a key destination for campaigns and advocacy initiatives focused on improving access to and affordability of treatment. 

Photo Source: PAN Foundation

Our first campaign addresses the need to lower out-of-pocket costs for prescription medications in Medicare Part D. In one click, we make it easy for you or your constituents to send an email to their elected officials, letting them know that relief from out-of-pocket costs for millions of Americans is desperately needed – NOW! Information about this campaign is included below. 

My ask of you?

As soon as you can, please encourage your patient communities to visit PAN’s advocacy action center, learn more about this campaign, and take immediate action by writing their members of Congress. It is easy, important, and needed as we head into the fall months.

If you need any assistance or have ideas for encouraging patients to share their stories, and their voices, do not hesitate to reach out to me. Learn more at https://www.panfoundation.org/become-an-advocate/.

Thanks, as always, for all you do. 

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

Medicare's Low-Income Subsidy Program

By: Amy Niles, Vice President, External Relations, Patient Access Network (PAN) Foundation

Access to medically necessary healthcare is critical for successful patient outcomes, yet access is often impeded or blocked entirely by high deductibles, co-pays and coinsurance. These out- of-pocket (OOP) costs hit low-income seniors especially hard. For economically vulnerable Medicare beneficiaries and people with disabilities, the Low-Income Subsidy (LIS) program is a critical safety net that helps cover OOP costs for prescription drugs. The PAN Foundation's Issue Brief describes the LIS program, how it helps low-income seniors and people with disabilities, and what more can be done to ensure that OOP drug costs do not prevent these beneficiaries from getting the treatment they need.

WHAT IS THE LIS PROGRAM AND WHO IS ELIGIBLE?

All Medicare beneficiaries are eligible for prescription drug coverage through Medicare Part D drug plans. Medicare beneficiaries with low incomes and very few assets (e.g. bank accounts, stocks, bonds, etc.) as well as some people with disabilities may qualify for the LIS program, which helps cover OOP prescription drug costs. Also called “Extra Help,” the LIS program shields economically vulnerable and disabled beneficiaries from high OOP drug costs by helping them pay for monthly premiums, annual deductibles and co-payments for prescription medications obtained through Medicare prescription drug programs.[1]

The LIS program is divided into two parts: the “Full LIS program” and the “Partial LIS program,” and they differ based on who is eligible, how people enroll, and how much support the program provides for OOP drug costs.

To learn more about the LIS program, download the PAN Foundation's Issue Brief 11 - Medicare’s Low-Income Subsidy Program.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

An Inherent Value in Advocacy Partnerships...AGAIN! CMS Backs Down on Medicare Part D's Six Protected Drug Classes

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

In a blog posted last summer we highlighted why advocacy partnerships are so important to the HIV/AIDS community, and how these partnerships advance public policies designed with patients' interests in mind. Last week, we were reminded...AGAIN...why there is an inherent value in advocacy partnerships. The Centers for Medicare & Medicaid Services ("CMS") released its Final Rule on Medicare Part D, which did not include potential harmful changes to its six protected drug classes ("6PC").

Photo Source: indystar.com

The 6PC "protects vulnerable seniors and low-income beneficiaries with serious and complex health conditions, while also allowing Part D insurance plans to use the tools they need to control costs. Medicines for some of the sickest patients in Part D are covered within the six protected classes, including those for cancer, epilepsy, HIV/AIDS and mental illness. Many of these conditions require patients to attempt a variety of therapies before they and their doctor settle on the most appropriate treatment, so there is no one-size fits all medicine for these conditions."[1]

The current Administration had proposed to weaken these drug class protections, but their attempt was met with fierce opposition from the pharmaceutical industry, patient advocacy groups, and numerous powerful trade associations. Fortunately, in the end, CMS decided to walk back from their short-sighted proposal.[2]

The ADAP Advocacy Association discussed the issue at its recent HIV/AIDS Fireside Chat retreat in California, we all as endorsed numerous national sign-on letters and continually Tweeted to @CMSGov about the potential harm to people living with HIV/AIDS.

Reaction to the news was universally positive!

"The epilepsy community spoke up loudly against this proposal and we are grateful that the Administration heard us," said Philip M. Gattone, M.Ed., president and CEO of the Epilepsy Foundation. "For people living with epilepsy, there is no 'one-size-fits-all' anticonvulsant, and treatment is highly individualized. People with epilepsy need access to the full range of anticonvulsants so that they — along with their healthcare provider — can identify and remain on the medication(s) that helps them achieve seizure control. Preserving this important policy will enable that to happen."[3]

Altha Stewart, M.D., President of the American Psychiatric Association, said, "With adherence to medications already a challenge, this proposal would have added additional utilization management burden which contributes to burnout for clinicians, as well as confusion for patients trying to navigate an already complex system. This rule protects patients by ensuring they receive lifesaving medications through the protected classes."[4]

“Medicare beneficiaries with the most complex, chronic conditions are breathing a sigh of relief,” said Chuck Ingoglia, executive director of the Partnership for Part D Access, a coalition of drug makers and patient advocacy organizations that also opposed the proposal. “This rule cements Medicare’s protected classes policy as an essential patient safeguard in Medicare’s prescription drug program.”[5]

In 2014, like this year, advocacy partnerships also squashed attempts by the previous Administration to weaken Medicare Part D's 6PC. It demonstrates that stakeholders can from time to time, unite behind common goals. In the case of the 6PC proposals in 2014 and 2019 it was patient protections that won the day.

CMS's Final Rule also prohibits the use of step therapy for patients who are stable on their current treatment.[6] Yet another win for patients, which was achieved by different stakeholder groups uniting against the dangers of step therapy.

Advocacy partnerships prove that stakeholders don't have to agree on everything, yet can come together to advance (or protect) common interests. What happened last week with the CMS announcement shows that people living with HIV/AIDS are well-served by such collaboration. Chalk one up for us, finally!


__________
[1] Johnson, Juliet (2019, January 31). New Research Shows Changes to the Six Protected Classes Would Harm Most Vulnerable Patients and Are Unnecessary. ADAP Blog. Retrieved online at https://adapadvocacyassociation.blogspot.com/2019/01/new-research-shows-changes-to-six.html.
[2] Owermohle, Sarah, and Sarah Karlin-Smith. (2019, May 17). Patient groups, pharma cheer CMS retreat on protected class change. POLITICO. Retrieved online at https://www.politico.com/newsletters/prescription-pulse/2019/05/17/patient-groups-pharma-cheer-cms-retreat-on-protected-class-change-437838.
[3] Epilepsy Foundation. (2019, May 17). Epilepsy Advocates and Partners Successfully Preserve Medicare's Six Protected Classes Policy. Business Insider. Retrieved online at https://markets.businessinsider.com/news/stocks/epilepsy-advocates-and-partners-successfully-preserve-medicare-s-six-protected-classes-policy-1028210785.
[4] American Psychiatric Association. (2019, May 17). APA Commends CMS for Maintaining Medicare's Six Protected Classes Policy. Retrieved online at https://www.psychiatry.org/newsroom/news-releases/apa-commends-cms-for-maintaining-medicare-s-six-protected-classes-policy.
[5] Florko, Nicholas. (2019, May 16). Trump administration backs off a proposal to let Medicare plans exclude certain drugs. STAT. Retrieved online at https://www.statnews.com/2019/05/16/trump-backs-off-protected-classes/.
[6] Biotechnology Innovation Organization. (2019, May 20). Final Medicare Rule Improves Patient Rx Access, But Challenges Remain.